WO2022173024A1

WO2022173024A1 - Clip device and method of operating clip device

Info

Publication number: WO2022173024A1
Application number: PCT/JP2022/005503
Authority: WO
Inventors: Masaru Yuasa; Yoshitsugu Uekusa; Shinya ANSAI; Takushi Haramaki; Shogo SHINDO; Tatsunori Tsuneto
Original assignee: Olympus Medical Systems Corp.
Priority date: 2021-02-12
Filing date: 2022-02-10
Publication date: 2022-08-18

Abstract

This clip device including: a sheath including a lumen and at least one open end; a plurality of clip arms movable between a first configuration in which the plurality of clip arms are opened to receive a target tissue, and a second configuration, in which the plurality of clip arms are closed to grip the target tissue; locking mechanisms respectively provided on the plurality of clip arms to engage one another for maintaining the second configuration; and a restraining mechanism configured to be associated with the locking mechanisms to prevent the target tissue from being pinched between the locking mechanisms.

Description

CLIP DEVICE AND METHOD OF OPERATING CLIP DEVICE

This application is based on and claims priority under 35 U.S.C. §119 to U.S. Provisional Application No. 63/148,655, filed February 12, 2021, and No. 63/187,651 filed May 12, 2021. The entire contents of each of these applications are incorporated herein by reference.

The present invention relates to a clip device for an endoscope, and more particularly, to an endoscopic clip device with an improved mechanism for locking the clip arms of the clip device.

The present disclosure relates to a clip device for gripping tissue of a patient that includes a clip configured with latches to lock the clip in the closed state for use with surgical tools such as endoscopes and a method of operating the clip device.

Various endoscopic clip devices have been known, many of which require hemostasis clips to control internal bleeding. The hemostasis clips grasp tissue surrounding a wound and hold edges of the wound together temporarily to allow natural healing processes to permanently close the wound. Specialized endoscopic clip devices are used to deliver the hemostasis clips at the desired locations within the body after which the endoscopic clip delivery device is withdrawn, leaving the hemostasis clips within the body. Such a conventional endoscopic clip device may be loaded onto a distal end of an applicator assembly prior to an endoscopic procedure. Once a hemostasis clip has been deployed at a desired target area in the body, the applicator assembly may be reloaded with a new clip unit.

The conventional endoscopic clip device includes a pair of clip arms, proximal ends of which are connected to a connector that is configured to releasably engage a distal end of a control member of an applicator. The clip arms include respective locking mechanisms to lock the clip arms when a target tissue is gripped, such that the clip arms may be drawn toward one another until the locking mechanisms engage one another. Once the clip arms have been locked, a proximal force beyond a predetermined threshold value may be exerted on the control member, disengaging the control member from the connector so that the control member may be coupled to a new clip unit.

In the discussion that follows, reference is made to certain structures and/or methods. However, the following references should not be construed as an admission that these structures and/or methods constitute prior art. Applicant expressly reserves the right to demonstrate that such structures and/or methods do not qualify as prior art against the present invention.

Various treatment tools can be used with surgical tools, such as endoscopes, for a variety of therapeutic procedures such as to prevent tissue bleeding, closing perforations, and other surgical procedures. Such treatment tools can grasp tissue within a clip and lock the clip by operation of a wire connected to the clip. However, users of such tools can unintentionally lock the clip when operating the wire during a therapeutic procedure.

However, the locking mechanisms of the conventional endoscopic clip device are deficient in one or more ways. For example, when the conventional locking mechanisms are moved to lock the clip arms, the target tissue may be pinched between the locking mechanisms. In this situation, the locking mechanism cannot function properly, thereby causing an undesirable hemostasis procedure.

Furthermore, a continuing need exists for treatment tools that can be used with endoscopes which can minimize locking of clips when not intended.

Accordingly, the present disclosure is directed to an endoscopic clip device and clip unit, which substantially obviate one or more of the issues due to limitations and disadvantages found in conventional endoscopic clip devices and clip units.

An object of the present disclosure is to provide a clip device, which comprises a sheath having a lumen with at least one open end and a plurality of clip arms movable between a first configuration in which the plurality of clip arms are opened to receive a target tissue, and a second configuration in which the plurality of clip arms are closed to grip the target tissue. Locking mechanisms respectively provided on the plurality of clip arms engage one another for maintaining the second configuration. A restraining mechanism is optionally configured to be associated with the locking mechanisms to prevent the target tissue from being pinched between the locking mechanisms.

Another object of the present disclosure is to provide an endoscopic clip device system for treating tissue, which comprises a clip unit including a pair of clip arms, a proximal end of the clip arms connected to a connector, the clip unit movable between a first configuration, in which distal ends of the clip arms are separated from one another to receive a target tissue therebetween, and a second configuration, in which the target tissue is gripped by the clip arms; locking mechanisms respectively disposed on the clip arms for locking the clip arms in the second configuration; an applicator including a sheath and a control member extending therethrough, the sheath extending from a proximal end to a distal end and including a lumen extending therethrough, the control member extending from a proximal end to a distal end configured to be releasably coupled to the connector to move the clip unit between the first configuration and the second configuration, the clip arms being constrained toward the second configuration via a surface of the lumen when the clip arms are drawn proximally thereinto; and a restraining structure configured to operate associated with the clip unit to prevent the target tissue from being pinched between the locking mechanisms.

Still another object of the present disclosure is to provide a method of delivering an endoscopic clip device, which comprises loading a first clip unit on an applicator by coupling a control member of the applicator to a connector at a proximal end of clip arms of the first clip unit; inserting the first clip unit to a target site within a patient via a channel of an endoscope; moving the first clip unit between a first configuration, in which distal ends of the clip arms are separated from one another, and a second configuration, in which the distal ends of the clip arms are drawn toward one another, by moving the control member longitudinally until a target tissue is gripped between the distal ends of the clip arms; locking the clip arms in the second configuration by drawing the control member further proximally until the clip arms engage one another via a locking mechanism thereof; and releasing the first clip unit from the applicator by drawing the control member even further proximally until a proximal force exerted on the connector by the control member exceeding a predetermined threshold value so that the control member disengages from the connector to release the clip assembly from the applicator, wherein, in the second configuration, when the clip arms are drawn toward one another, a restraining mechanism is operated to prevent the target tissue from being pinched between the locking mechanisms.

Additional features and advantages will be set forth in the description that follows, and in part will be apparent from the description, or may be learned by practice of the invention. The objectives and other advantages of the disclosed an endoscopic clip device, a system and a method will be realized and attained by the structure particularly pointed out in the written description and claims thereof as well as the appended drawings.

An advantage of the present disclosure includes a treatment tool or device that includes a clip than can be reciprocally closed and opened in one operation and locked in a separate operation, distinct from the operation of reciprocally closing and opening the clip.

These and other advantages are satisfied, at least in part, by a clip device comprising a clip having a first arm and second arm in which the first arm and second arm are configured to move in a reciprocal direction toward and away from each other to close and open the clip; a wire connected to a proximal end of the clip configured to reciprocally move within a sheath to close and open the clip; and one or more latch elements on the clip configured to lock the clip in a closed state. Advantageously, operating the wire does not lock the clip in a closed state in a single operation. Rather, the clip can be locked by another operation, e.g., a second operation, such as by operating a stopper or by operating a control member reciprocally movable within the sheath to slid over the clip arms or to slid a locking ring over the clip.

Another aspect of the present disclosure includes a method of operating a clip device that includes closing a clip having a first arm and second arm biased in an open state and having one or more latch elements by pulling a wire connected to a proximal end of the clip to retract the clip in a tube or pipe (tube and pipe are used interchangeably herein); and locking the clip in a closed state by moving a stopper or by an operation other than pulling the wire to close the clip. The method can further include locking the clip by sliding a locking ring distally over the one or more latch elements and/or locking the clip by sliding a control member, e.g., an inner sheath, over the clip to lock mating latch elements.

Additional embodiments of the present disclosure include one or more of the following features individually or combined. For example, the clip device of claim can further include a locking ring that can slidably move over the one or more latch elements to lock the clip. The locking ring and the one or more latch elements can have complementary mating portions, which lock the locking ring to the one or more latch elements to lock the clip. In some embodiments, the first arm or second arm or both arms can include a projection that prevent(s) the arms from fully retracting in a tube distally connected to the sheath. In other embodiments, the clip device can further include a control member, e.g., an inner sheath, reciprocally movable within the sheath by operation of a control knob that is configured to slidably move the locking ring over the one or more latch elements to lock the clip. In still further embodiments, the first arm includes a first latch element and the second arm includes a second latch element opposite the first latch element and configured to engage the first latch element to lock the clip. In other embodiments, the clip device can further include a tube connected to a distal end of the sheath, which does not disconnect from the sheath.

In further embodiments, the clip device can further include a stopper connected to the wire, such as to a distal end region of the wire and the device can further include a control member, e.g., an inner sheath, reciprocally movable within the sheath by operation of a control knob. The stopper can be configured to abut a distal end of the inner sheath when the clip is in a closed state which prevents the wire from locking the clip and the inner sheath can be configured to move proximally to allow operating the wire to move proximally to lock the clip. In other embodiments, the clip device can further include a stopper configured to stop the wire from moving proximally. In some embodiments, the clip device can further include a handle having a main body and a slit with a slider located in the slit. The slider can be connected to a proximal end of the wire and the can be stopper located in the slit to prevent the slider from moving to a proximal end of the slit. In other embodiments, the stopper are protrusions that face each other on the first arm and second arm and the device further includes a tube with a pin in which the pin abuts the stoppers when the clip is retracted proximally in the tube.

Additional advantages of the present invention will become readily apparent to those skilled in this art from the following detailed description, wherein only the preferred embodiment of the invention is shown and described, simply by way of illustration of the best mode contemplated of carrying out the invention. As will be realized, the invention is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

The present disclosure is directed to a clip device to improve mechanism for locking the clip arms of the clip device which substantially obviate one or more of the issues due to limitations and disadvantages found in conventional clip device.

The present disclosure is directed to a clip device to be used with endoscopes which can minimize locking of clips when not intended.

FIG. 1 shows a perspective view of a system according to an exemplary embodiment of the present invention. FIG. 2 shows a side view of a distal portion according to the system of FIG. 1. FIG. 3A shows a side view of an applicator according to the system of FIG. 1. FIG. 3B is an enlarged view of an applicator according to the system of FIG. 1. FIG. 3C is an enlarged view of an applicator according to the system of FIG. 1. FIG. 4 shows a side view of a distal portion of the applicator of FIG. 3. FIG. 5 shows a longitudinal cross-sectional view of the distal portion of FIG. 4. FIG. 6 shows a perspective view of a portion of the applicator of FIG. 3. FIG. 7 shows a longitudinal cross-sectional view of the portion of the applicator of FIG. 6. FIG. 8A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to an exemplary embodiment. FIG. 8B is a magnified cross-sectional view taken line A-A of FIG. 8A. FIG. 8C is a front view schematically illustrating a clip unit in the first configuration in which restraining members are located on the pair of clip arms more proximally than locking members according to an exemplary embodiment. FIG. 8D is a perspective view schematically illustrating an exemplary structural arrangement between restraining members and locking members. FIG. 8E is a perspective view schematically illustrating another exemplary structural arrangement between restraining members and locking members. FIG. 9A is a front view schematically illustrating a clip unit in a second configuration in which the target tissue is gripped by the pair of clip arms are according to an exemplary embodiment. FIG. 9B is a magnified cross-sectional view taken line B-B of FIG. 9A. FIG. 10A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to another exemplary embodiment. FIG. 10B is a magnified cross-sectional view taken line C-C of FIG. 10A. FIG. 11A is a front view schematically illustrating a clip unit in a second configuration in which the target tissue is gripped by the pair of clip arms are according to another exemplary embodiment. FIG. 11B is a cross-sectional view taken line D-D of FIG. 11A. FIG. 12A shows side view of distal portions of additional exemplary embodiment of a clip device system related to the first embodiment. FIG. 12B shows side view of distal portions of additional exemplary embodiment of a clip device system related to the first embodiment. FIG. 13A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to a further exemplary embodiment. FIG. 13B is a front view schematically illustrating a clip unit in a second configuration in which the pair of clip arms are closed and grip the target tissue. FIG. 14A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to another exemplary embodiment. FIG. 14B is a magnified cross-sectional view taken line E-E of FIG. 14A. FIG. 15A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to another exemplary embodiment. FIG. 15B is a magnified cross-sectional view taken line F-F of FIG. 15A. FIG. 16 is a view schematically illustrating a clip unit with a restraining rail that is inserted into a channel of an endoscope according to an exemplary embodiment. FIG. 17 a view schematically illustrating a clip unit with a restraining rail that is in a first configuration according to an exemplary embodiment. FIG. 18 shows a side view of a distal portion of an additional exemplary embodiment of a clip device system related to the second embodiment. FIG. 19A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to an exemplary embodiment. FIG. 19B is a side view schematically illustrating the clip unit of FIG. 19A. FIG. 19C is a side view schematically illustrating the clip unit of FIG. 19A when the clip unit is drawn into a sheath toward a second configuration. FIG. 19D is a side view schematically illustrating the clip unit of FIG. 19A when the clip unit is the second configuration. FIG. 20A1 is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to one exemplary embodiment. FIG. 20A2 is a cross-sectional view taken line I-I of FIG. 20A1. FIG. 20B1 is a front view schematically illustrating a clip unit in a second configuration in which a pair of clip arms are closed to grip the target tissue. FIG. 20B2 is a cross-sectional view taken line II-II of FIG. 20B1. FIG. 20C1 is a front view schematically illustrating a clip unit in the first configuration according to another exemplary embodiment that is different from the one in FIG. 20A. FIG. 20C2 is a cross-sectional view taken line III-III of FIG. 20C1. FIG. 21 shows a side view of a distal portion of an additional exemplary embodiment of a clip device system related to the third embodiment. FIG. 22A is a side view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened according to a still further exemplary embodiment. FIG. 22B is a top view schematically illustrating the clip unit of FIG. 22A. FIG. 22C is a side view schematically illustrating the clip unit in a second configuration in which the pair of clip arms are closed. FIG. 22D is a top view schematically illustrating the clip unit of FIG. 22C. FIG. 23 is a perspective view schematically illustrating an applicator of an endoscope using a clip unit according to one exemplary embodiment. FIG. 24 is a perspective view schematically illustrating the clip unit to be associated with the applicator of FIG. 23. FIG. 25 schematically illustrates a clip device with a clip having latch parts protruding from arms of the clip and configured to lock the clip in a closed state by pulling a wire in a single operation. FIG. 26A schematically illustrates a clip device with a latch element on a clip arm configured to lock the clip in a closed state by slidably moving a locking ring over the latch element with a control member in accordance with aspect of the present disclosure. FIG. 26B schematically illustrates a clip device with a latch element on a clip arm configured to lock the clip in a closed state by slidably moving a locking ring over the latch element with a control member in accordance with aspect of the present disclosure. FIG. 26C schematically illustrates a clip device with a latch element on a clip arm configured to lock the clip in a closed state by slidably moving a locking ring over the latch element with a control member in accordance with aspect of the present disclosure. FIG. 26D schematically illustrates a clip device with a latch element on a clip arm configured to lock the clip in a closed state by slidably moving a locking ring over the latch element with a control member in accordance with aspect of the present disclosure. FIG. 27A schematically illustrates a clip device with latch elements on clip arms and a locking ring complementary mating portions to the latch elements which lock the ring to the latch elements and lock the clip in a closed state in accordance with aspect of the present disclosure. FIG. 27B schematically illustrates a clip device with latch elements on clip arms and a locking ring complementary mating portions to the latch elements which lock the ring to the latch elements and lock the clip in a closed state in accordance with aspect of the present disclosure. FIG. 27C schematically illustrates a clip device with latch elements on clip arms and a locking ring complementary mating portions to the latch elements which lock the ring to the latch elements and lock the clip in a closed state in accordance with aspect of the present disclosure. FIG. 27D1 is an enlarged view of the locking ring with complementary mating portion to the latch elements on the clip arms of FIG. 27A. FIG. 27D2 schematically illustrates an examples of latch elements on clip arms of clip and complementary mating portions on locking ring to the latch elements on the clip arms of FIG. 27D1. FIG. 27D3 schematically illustrates an examples of latch elements on clip arms of clip and complementary mating portions on locking ring to the latch elements on the clip arms of FIG. 27D1. FIG. 27D4 schematically illustrates an examples of latch elements on clip arms of clip and complementary mating portions on locking ring to the latch elements on the clip arms of FIG. 27D1. FIG. 28A schematically illustrates a clip device including a clip having a first and second arm in which the first arm includes a first latch element and the second arm includes a second latch element opposite the first latch element and configured to engage the first latch element to lock the clip in accordance with aspect of the present disclosure. FIG. 28B schematically illustrates a clip device including a clip having a first and second arm in which the first arm includes a first latch element and the second arm includes a second latch element opposite the first latch element and configured to engage the first latch element to lock the clip in accordance with aspect of the present disclosure. FIG. 28C schematically illustrates a clip device including a clip having a first and second arm in which the first arm includes a first latch element and the second arm includes a second latch element opposite the first latch element and configured to engage the first latch element to lock the clip in accordance with aspect of the present disclosure. FIG. 28D schematically illustrates a clip device including a clip having a first and second arm in which the first arm includes a first latch element and the second arm includes a second latch element opposite the first latch element and configured to engage the first latch element to lock the clip in accordance with aspect of the present disclosure. FIG. 29A schematically illustrates a clip device including a clip, a wire connected to a proximal end of the clip, a stopper connected to a distal end region of the wire and an inner sheath reciprocally movable within a sheath by operation of a control knob in accordance with aspect of the present disclosure. FIG. 29B schematically illustrates a clip device including a clip, a wire connected to a proximal end of the clip, a stopper connected to a distal end region of the wire and an inner sheath reciprocally movable within a sheath by operation of a control knob in accordance with aspect of the present disclosure. FIG. 29C schematically illustrates a clip device including a clip, a wire connected to a proximal end of the clip, a stopper connected to a distal end region of the wire and an inner sheath reciprocally movable within a sheath by operation of a control knob in accordance with aspect of the present disclosure. FIG. 29D schematically illustrates a clip device including a clip, a wire connected to a proximal end of the clip, a stopper connected to a distal end region of the wire and an inner sheath reciprocally movable within a sheath by operation of a control knob in accordance with aspect of the present disclosure. FIG. 30A schematically illustrates a clip device including a removable stopper on an operational handle of the device in accordance with aspect of the present disclosure. FIG. 30B schematically illustrates a clip device including a removable stopper on an operational handle of the device in accordance with aspect of the present disclosure. FIG. 31A schematically illustrates another clip device including a stopper in accordance with aspect of the present disclosure. FIG. 31B schematically illustrates another clip device including a stopper in accordance with aspect of the present disclosure. FIG. 31C schematically illustrates another clip device including a stopper in accordance with aspect of the present disclosure. FIG. 32A1 schematically illustrates another clip device including a stopper in accordance with aspects of the present disclosure. FIG. 32A2 is top view of the stopper of another clip device including a stopper in accordance with aspects of the present disclosure. FIG. 32A3 schematically illustrate an inner sheath side surface of another clip device including a stopper in accordance with aspects of the present disclosure. FIG. 32B schematically illustrate another clip device including a stopper in accordance with aspects of the present disclosure. FIG. 33A schematically illustrates another clip device including a stopper in accordance with aspect of the present disclosure. FIG. 33B schematically illustrates another clip device including a stopper in accordance with aspect of the present disclosure. FIG. 34A schematically illustrates another clip device including a stopper in accordance with aspect of the present disclosure. FIG. 34B schematically illustrates another clip device including a stopper in accordance with aspect of the present disclosure.

(Chapter 1)
The following detailed description of preferred embodiments can be read in connection with the accompanying drawings in which like numerals designate like elements.

Throughout all of the drawings, dimensions of respective constituent elements are appropriately adjusted for clarity. For ease of viewing, in some instances only some of the named features in the figures are labeled with reference numerals.

Hereinafter, accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate exemplary embodiments of the invention, and together with the general description given above and the detailed description of the exemplary embodiments given below, serve to explain the principles of the invention.

Also, it should be noted that the terms “proximal” and “proximally” as used herein, are intended to refer to a direction toward (proximal/proximally) a user of the device, and the terms “distal” and “distally” as used herein, are intended to refer to a direction away from (distal/distally) the user of the device. The term “patient,” as used herein, comprises any and all organisms and includes the term “subject.” A patient can be a human or an animal.

FIG. 1 shows a perspective view of an exemplary clip device system 100 and FIG. 2 shows a side view of a distal portion of the exemplary clip device system 100. As shown in FIGS. 1 and 2, the clip device system 100 comprises a clip unit 102, an applicator 104 (clip device), and a cartridge 106. The clip unit 102 is loadable into a distal portion of the applicator 104 before the system 100 is inserted into a living body to clip a target tissue. The applicator 104 is configured such that, after deployment of the clip unit 102 in the body of a patient, a new clip unit 102 may be loaded onto the applicator 104 so that the same applicator 104 may be used to deliver a new clip unit 102 to a second portion of the target tissue in the patient. Each clip unit 102 according to this embodiment may be stored in the cartridge 106, which facilitates loading of the clip unit 102 onto the applicator 104.

Specifically, as shown in FIG. 1, prior to being loaded on the applicator 104, the clip unit 102 is stored in the cartridge 106, which may be configured, for example, as a storage container so that the clip unit 102 may be securely stored therein. In one embodiment, the clip unit 102 may be stored in the cartridge 106 in a first configuration (tissue receiving configuration). The cartridge 106 includes a proximal opening 174 through which a distal portion of the applicator 104 (e.g., a distal end of the control member 110 and a distal end of the sheath 108) may be inserted into the cartridge 106 to load the clip unit 102 thereon. Once the distal end 118 of the control member 110 has been coupled to the connector 116 of the clip unit 102, the clip unit 102 may be drawn toward a second configuration (tissue gripping configuration) to remove the clip unit 102 from the cartridge 106.

The applicator 104 includes a sheath 108 at a distal end of the applicator 104 and a control member 110 extending through the applicator 104. The clip unit 102 includes a pair of clip arms 112 including a proximal end 114 connected to a connector 116 that is configured to releasably engage a distal end 118 of the control member 110. Once the clip unit 102 has been connected to the control member 110, the clip unit 102 may be moved with respect to the sheath 108 between a first configuration, which is a tissue receiving configuration in which the pair of clip arms 112 are opened to receive a target tissue, and a second configuration, which is a tissue gripping configuration in which the target tissue is gripped by the pair of clip arms 112.

As shown in FIGS. 3A-7, the applicator 104 includes the sheath 108, a flexible member 120 extending proximally from the sheath 108, and the control member 110 extending through the sheath 108 and the flexible member 120. A proximal end of the flexible member 120 is connected to a handle member 122, which includes an actuator such as, for example, a spool 124, coupled thereto. In one example, the spool 124 is connected to a proximal end 126 of the control member 110 so that, once the clip unit 102 is loaded onto the applicator 104, the spool 124 may be slid longitudinally over the handle member 122 to move the clip unit 102 between the first configuration (tissue receiving configuration) and the second configuration (tissue gripping configuration). Specifically, sliding the spool 124 over the handle member 122 moves the control member 110, and thereby the clip unit 102, relative to the sheath 108 to move the clip unit 102 between the first and second configurations.

In one embodiment, as shown in FIGS. 6-7, the handle member 122 includes a positioning feature 128 interfacing with the spool 124 to provide tactile feedback to a user of the exemplary clip device system 100 regarding a position of the connector 116 with respect to the sheath 108. The positioning feature 128 may include a deformable protrusion extending laterally outward from an exterior surface therefrom. The protrusion is deformable so that the spool 124 may be slid over the protrusions when a force exerted thereon exceeds a predetermined threshold value. The spool 124 may be slid over the protrusions during initial loading of the clip unit 102. However, when a distal surface 130 of the spool 124 abuts a portion of the protrusion, the positioning feature 128 provides a tactile feedback to the user indicating that the connector 116 is at a distal-most position with respect to the sheath 108, without extending entirely distally past the sheath 108. In other words, the clip unit 102 is at a maximum open configuration without extending entirely out of the sheath 108 (e.g., separated from the sheath 108).

Moreover, as shown in FIGS. 3B-3C, a part of the handle member 122 may be cut off to form a recess portion, and a lid member 129, which is a roof-shaped cover, may be detachably fit into the handle member 122 to cover the recess portion. The lid member 129 has a projection 129a formed at a proximal end of the lid member 129. The projection 129a is configured to engage with the positioning feature 128 so that the lid member 129 is prevented from coming off the handle member 122.

The flexible member 120 (e.g. in FIGS. 1 and 3) may be formed as a coil of wire through which the control member 110 extends from the distal end 118 to the proximal end 126. As would be understood by those skilled in the art, the coil of wire preferably has sufficient flexibility to be passed through even tortuous paths of living body and, in this exemplary embodiment, is sized and shaped to permit it to be passed through a channel of an endoscope or other insertion device. Although the flexible member 120 is shown and described as a coil of wire, it will be understood by those of skill in the art that any other suitable flexible structure may be employed so long as the flexible member 120 is capable of providing a force in compression sufficient to counter the tension to be placed on the control member 110 from the clip unit 102. Although the applicator 104 is described as including the spool 124, the applicator 104 may include any of a variety of actuating mechanisms for moving the control member 110 to control movement of the clip arms 112.

The control member 110 extends from the distal end 118 releasably coupled to the connector 116 to the proximal end 126 connected to the spool 124. The distal end 118 is sized and shaped to be releasably coupled to a corresponding feature of the connector 116. In one embodiment, the distal end 118 may be shaped as an enlarged ball that is received within a correspondingly shaped socket of the connector 116. It will be understood by those of skill in the art, however, that the distal end 118 may have any of a variety of shapes and sizes so long as the distal end 118 is releasably coupleable with the connector 116.

As shown in FIG. 2, the connector 116 includes a distal end 148 connected to the proximal end 114 and extends proximally therefrom to receive the distal end 118 of the control member 110 therein. The connector 116 includes a longitudinal slot 160 defined via opposed portions 162 that are spreadable to receive the distal end 118 of the control member 110. The longitudinal slot 160 extends from a proximal opening 164 to a space 166 sized and shaped to receive the distal end 118. In one exemplary embodiment, the distal end 118 may be configured as a ball received within a correspondingly sized and shaped socket of the space 166. The proximal opening 164 of the slot 160 has a smaller cross-sectional area (e.g., diameter) than a cross-sectional area of the space 166. The opposed portions 162 are spreadable to receive the distal end 118 of the control member 110 and biased toward one another so that, once the distal end 118 passes distally into the space 166, the opposed portions 162 spring back to lock the distal end 118 within the space 166, coupling the control member 110 to the connector 116. Thus, longitudinal movement of the control member 110 relative to the sheath 108 may control movement of the clip arms 112 between the tissue receiving and the tissue clipping configurations.

According to this embodiment, the distal end 118 of the control member 110 may be inserted into the connector 116 via the proximal opening 164. When the control member 110 is pushed distally into the connector 116 beyond a predetermined threshold value, the proximal opening 164 of the longitudinal slot 160 deforms to permit the distal end 118 to be passed through the proximal opening 164 into the space 166. In one embodiment, opposed portions 162 defining the longitudinal slot 160 may be separated from one another to permit the distal end 118 to be passed through the proximal opening 164 into the space 166. Once the distal end 118 is received within the space 166, the longitudinal slot 160 reverts to its original size, holding the distal end 118 of the control member 110 therein.

As shown in FIGS. 4 and 5, the sheath 108 extends longitudinally from a proximal end 132 connected to a distal end 134 of the flexible member 120 to a distal end 136 and including a lumen 138 extending therethrough. The lumen 138 may be sized and shaped to receive at least a portion of the clip unit 102 therein. The lumen 138 includes a shoulder 176 along a proximal portion of the lumen 138 which reduces a cross-sectional area of the lumen 138 proximally thereof so that, the connector 116 is prevented from passing proximally past the shoulder 176. The sheath 108 may be configured as a hypotube attached to the distal end 134 of the flexible member 120. The sheath 108 may be laser cut to increase a flexibility thereof. For example, the sheath 108 may include a helically extending cut therealong so that the sheath 108 may be flexed along a length thereof. Moreover, the sheath 108 may be such a coil sheath that is configured to include a PTFE tube provided between the coil sheath and stranded wires of multiple metal wires inserted through the sheath 108. The stranded wires of multiple metal wires may be coated by silicon as a lubricant.

As shown in FIG. 2, the clip unit 102 includes the pair of clip arms 112, which have a proximal end 114 connected to the connector 116. In one embodiment, the pair of clip arms 112 may be formed of a single piece of material bent in half at the proximal end 114 to form the two clip arms 112. The connector 116 may be connected to the single piece of material at the point at which the material bends (e.g., the proximal end 114) to form the two clip arms 112. Although the clip arms 112 are described and shown as being formed of the single piece of material, the pair of clip arms 112 may be formed via two separate pieces of material, proximal ends of which are connected to one another via the connector 116.

The clip arms 112 of this embodiment are biased so that distal ends 140 of the clip arms 112 move apart from one another into an open tissue receiving configuration when not drawn into the sheath 108. When drawn into the sheath 108, the sheath 108 constrains the clip arms 112, holding the distal ends 140 of the clip arms 112 together in a closed tissue gripping configuration. The connector 116 is longitudinally slidable with the lumen 138 of the sheath 108 to move the clip arms 112 between the tissue receiving configuration and the tissue gripping configuration. The distal ends 140 of each of the clip arms 112 may project laterally inward toward the distal end 140 of the other of the clip arms 112 to facilitate gripping of target tissue therebetween. The distal ends 140 may further include other gripping features such as, for example, teeth and/or protrusions.

The clip arms 112 may include locking mechanisms to lock the pair of clip arms when the clip unit 102 is in the closed tissue gripping configuration. In this exemplary embodiment, as shown in FIG. 2, the locking mechanisms include corresponding mating features 150, 152 (a pair of locking members) for locking the clip arms 112 in the closed tissue gripping configuration. A first one of the clip arms 112 includes a male lock feature 150 while a second one of the clip arms 112 includes a female lock feature 152. In particular, the male lock feature 150 is disposed on and extends from an inner surface of the first one of the clip arms 112 toward the second one of the clip arms 112 and includes a pair of prongs. The female mating feature 152 is disposed on and extends from an inner surface of the second one of the clip arms 112 toward the first one of the clip arms 112. The female mating feature 152 includes an opening that is sized and shaped to permit the pair of prongs to be received therein.

Additionally, on each arm, the restraining mechanism and the locking mechanism extend in a direction away from the arm different distances. For example and as shown in FIG. 2, a restraining member 181 of the restraining mechanism extends a first distance d1 in a first direction away from the first arm 112a and mating feature 150 of the locking mechanism extends a second distance d2 in the first direction away from the first arm 112a, and the first distance d1 is greater than the second distance d2.

The pair of prongs are deformable, and once the pair of prongs pass through the opening, the pair of prongs revert to their original configuration, locking the male locking member 150 within the female locking member 152. The male and

female locking members

150 and 152 are specifically configured so that the male and

female locking members

150 and 152 engage one another only when the pair of clip arms 112 are drawn toward one another beyond a predetermined threshold distance. Thus, the pair of clip arms 112 may be moved between the tissue receiving and tissue gripping configurations multiple times, as desired, prior to locking of the clip unit 102 in the tissue gripping configuration.

Although the clip unit 102 is described as including the

above locking mechanisms

150 and 152, it will be understood by those of skill in the art that a clip unit of the present disclosure may include any of a variety of corresponding mating features for locking the clip arms relative to one another.

The clip unit 102 further includes a restraining mechanism which is operated associated with the locking mechanisms and configured to prevent the target tissue from being pinched between the locking mechanisms when the clip unit 102 is drawn into the sheath 108 to close the pair of clip arms 112 toward the closed tissue gripping configuration. As will be described in details below, the restraining mechanism may have different configurations and may be disposed with different position relationships with respect to the locking mechanisms, as long as the restraining mechanism is configured to be suitable to prevent the target tissue to be pinched between the locking mechanisms.

First Embodiment
FIG. 8A schematically illustrates a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to a first exemplary embodiment, and FIG. 8B is a cross-sectional view taken line A-A of FIG. 8A. In the first exemplary embodiment, the clip unit 102 includes a restraining mechanism mounted on the pair of clip arms 112. Specifically, the restraining mechanism includes a first restraining member 181 and a second restraining member 182. The first restraining member 181 is disposed on and extends from an inner surface of a first one of the clip arms 112 toward a second one of the clip arms 112. The second restraining member 182 is disposed on and extend from an inner surface of the second one of the clip arms 112 toward the first one of the clip arms 112. The restraining first and

second members

181 and 182 may be located more distally than the locking

members

150 and 152, respectively. Alternatively, the restraining

members

181 and 182 may be attached to the distal end sides of the locking

members

150 and 152, respectively.

Moreover, as shown in FIG. 8C, the first restraining member 181 and the second restraining member 182 may be respectively located on the pair of clip arms 112 more proximally than the locking

members

150 and 152. In this situation, a distal end portion of the first restraining member 181a and a distal end portion of the second restraining member 182a should be positioned more distally than the locking

members

150 and 152, respectively. FIG. 8D is a perspective view schematically illustrating an exemplary structural arrangement between the restraining

members

181 and 182 and the locking

members

150 and 152. As shown in FIG. 8D, each of the restraining

members

181 and 182 may include an opening that is sized and shaped for a corresponding one of the locking

members

150 and 152 to extend from the inner surface of one of the clip arms 112 through the opening without interfering with the corresponding one of the restraining

members

181 and 182. FIG. 8E is a perspective view schematically illustrating another exemplary structural arrangement between the restraining

members

181 and 182 and the locking

members

150 and 152. As shown in FIG. 8E, the locking

members

150 and 152 may be each attached to two sides of the respective clip arms 112 so that the restraining

members

181 and 182 each extend passing through the

respective locking members

150 and 152 in a distal direction without interfering with the

respective locking members

150 and 152.

As described above, when the clip unit 102 is in the first configuration, the pair of clip arms 112 are opened to receive the target tissue 200. As will be described in detail below, the first and

second restraining members

181 and 182 are sized and shaped to prevent the target tissue 200 from being pinched between the locking

mechanisms

150 and 152 when the pair of clip arms 112 are moved to close and grip the target tissue 200.

In this exemplary embodiment, the first and

second restraining members

181 and 182 are each configured as a curved bar, which may have a flat/round front end surface that comes to contact with the target tissue 200 without hurting the target tissue 200, when the pair of clip arms 112 are moved to receive and grip the target tissue 200. The invention is not limited to the flat/round shape for the front end surface. The front end surface of each of the restraining

members

181 and 182 may have any suitable protection shape that can minimize or prevent the restraining

member

181 and 182 from causing unwanted damage to the target tissue 200. Additionally, when the restraining

members

181 and 182 are configured as a curved bar, the curvature can be such that the distal ends of the restraining members (i.e., the end not attached to the clip arms 181, 182) can be toward the distal end of the clip unit 102 (i.e., toward the opening through which the target tissue 200 is received by the clip unit 102) or can be toward the proximal end of the clip unit 102 (i.e., toward proximal end 114 connected to a connector 116).

The first and

second restraining members

181 and 182 may be formed of the same single piece of material that is employed to form the pair of clip arms 112 as noted above. Alternatively, the pair of restraining

members

181 and 182 may be formed of a different material from the pair of clip arms 112 and thus are attached to the pair of clip arms 112 during an assembly process by an adhesive substance or soldering.

The first and

second restraining members

181 and 182 may be made of any suitable biocompatible materials, such as, but not limited to, polymeric polymers and materials, including fillers such as metals, carbon fibers, glass fibers or ceramics, and combinations thereof. The metals may include cobalt chrome alloy, nickel titanium alloy, titanium, stainless steel, and the like. Useful, but non-limiting, polymeric materials include polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, polyvinyl acetate, polystyrene, polyethylene terephthalate), naphthalene dicarboxylatε derivatives, such as polyethylene naphthalate, polybutylene naphthalate, polytrimethylene naphthalate and trimethylenediol naphthalate, polyurethane, polyurea, silicone rubbers, polyamides, polycarbonates, polyaldehydes, natural rubbers, polyester copolymers, styrene-butadiene copolymers, polyethers, fully or partially halogenated polyethers, polyamidc/polyether polyesters, and copolymers and combinations thereof, and ABS (acrylonitrile butadiene styrene copolymer), PEEK (Poly Ether Ether Ketone), etc.

FIG. 9A is a front view schematically illustrating a clip unit in a second configuration in which the target tissue is gripped by the pair of clip arms are according to the first exemplary embodiment, and FIG. 9B is a cross-sectional view taken line B-B of FIG. 9A. Once the target tissue 200 is received between the clip arms 112 as shown in FIG. 8A, the clip assembly 102 is moved toward the second configuration, in which the target tissue 200 is gripped by the pair of clip arms 112, by moving the control member 110 proximally relative to the clip assembly 102. With the pair of clip arms 112 are closed to each other, the first and

second restraining members

181 and 182 are moved to contact each other and are deformed to extend distally, thereby pushing the target tissue away from the locking

mechanisms

150 and 152. As shown in FIG. 9B, the restraining

members

181 and 182 contact each other and form a stopping bar in front of the locking

mechanisms

150 and 152. The stopping bar formed by the restraining

members

181 and 182 is able to stop the target tissue 200 from entering into an area between the locking

mechanisms

150 and 152, thereby preventing the target tissue 200 from being pinched therebetween.

Also, the restraining

members

181 and 182 may be made flexible and deformable (i.e., movable toward one another). When the pair of clip arms 112 are closed further to each other, as shown in FIG. 9A, the stopping bar formed by the restraining

members

181 and 182 is moved further distally to keep the target tissue away from the locking

mechanisms

150 and 152.

When it is confirmed that a desired portion of the target tissue 200 is gripped between the clip arms 112 (e.g., portions of tissue on opposite sides of a bleeding wound), the control member 110 is drawn further proximally relative to the clip assembly 102 (via the spool 124) to lock the clip assembly 102 in the closed configuration. That is, the clip arms 112 are drawn further proximally into the sleeve 1088 until the locking

mechanisms

150, 152 engage one another, locking the clip arms 112 relative to one another.

FIG. 10A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to another exemplary embodiment. FIG. 10B is a cross-sectional view taken line C-C of FIG. 10A. FIG. 11A is a front view schematically illustrating a clip unit in a second configuration in which the target tissue is gripped by the pair of clip arms are according to another exemplary embodiment, FIG. 11B is a cross-sectional view taken line D-D of FIG. 11A.

In this modified exemplary embodiment, as shown in FIG. 10B, the restraining member 181 is disposed on the first one of the clip arms 112 at a position different from a position where the restraining member 182 is disposed on the second one of the clip arms 112. Thus, the restraining

members

182 and 182 do not contact each other even when the clip unit 102 is drawn toward the second configuration in which the pair of clip arms 112 are closed to grip the target tissue 200. As shown in FIGS. 11A and 11B, the restraining

member

181 and 182 cross each other in the second configuration, in which each of the restraining

member

181 and 182 serves as a stopping bar (anti-intrusion mechanism) to prevent the target tissue 200 from being pinched between the locking

mechanisms

150 and 152 when the locking

mechanisms

150 and 152 are moved to engage one another.

FIGS. 12A and 12B show side views of a distal portion of additional exemplary embodiments of a clip device system related to the first embodiment. The clip delivery system 100 includes a clip unit 102 attached to distal end of an applicator 104. For example, the clip unit 102 can be connected to a control member 110 via a connector 116. The control member 110 is movable within a plenum of the applicator 104 and manipulation of the control member 110, e.g., retracting and extending, moves the clip unit 102 to be withdrawn into at least a portion of the passage 10c or extended out from an opening at the distal end of the control member 110. Stop 56 serves to delimit the distance the clip unit 102 can move in the retracting direction.

As shown in FIGS. 12A and 12B, the clip unit 102 has two

clip arms

112a, 112b and the bases of the two

clip arms

112a, 112b are pivotable relative to each other about pivot connection 142a. In the embodiment shown, a groove or track 144 in the

clip arms

112a and 112b accommodates the movement of the

clip arms

112a and 112b as they move from the open position, i.e., the first configuration, to the closed position, i.e., the second configuration. Additionally, the clip unit 102 is pivotable and/or rotatable relative to the control member 110 about pivot connection 142b.

As with other embodiments disclosed herein, each

clip arm

112a and 112b includes locking mechanisms to lock the pair of

clip arms

112a and 112b when the clip unit 102 is in the closed tissue gripping configuration and the locking mechanisms includes corresponding mating features 150 and 152 (e.g., a pair of locking members - male lock feature 150 and female lock feature 15) for locking the clip arms 112 in the closed tissue gripping configuration. As with other embodiments disclosed herein, each

clip arm

112a and 112b also includes a restraining mechanism mounted on the pair of

clip arms

112a and 112b. Specifically, the restraining mechanism includes a first restraining member 181 and a second restraining member 182. Any of the embodiments disclosed herein for the locking mechanisms and restraining mechanism can be utilized in the clip unit 102 of the embodiment shown and described with respect to FIGS. 12A and 12B. In some embodiments, the clip unit 102 only includes a restraining mechanism (such as first restraining member 181 and second restraining member 182 as shown in FIG. 12B), which function to suppress tissue from entering the proximal side of the clip unit 102 and interfering with the pivoting of the clip unit 102. In other respects, such as other structural features, configuration and operation, the embodiments of the clip unit 102 and clip

arms

112a and 112b in FIGS. 12A and 12B can be consistent with the structural features, configuration and operation for the first embodiments describe above with reference to FIGS. 2 to 11.

Second Embodiment
FIG. 13A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to a second exemplary embodiment. FIG. 13B is a front view schematically illustrating a clip unit in a second configuration in which the pair of clip arms are closed and grip the target tissue according to the second exemplary embodiment.

In the second exemplary embodiment, the restraining mechanism is a restraining rail 184 that connects the locking mechanism 150 to the locking mechanism 152. The restraining rail 184 may be shaped as a bar and serves as a stopping bar between the locking

mechanisms

150 and 152. The restraining rail 184 is able to stop the target tissue 200 from entering into an area between the locking

mechanisms

As shown in FIG. 13A, the clip unit 102 includes the restraining rail 184, which has one end attached to a tip end of the locking mechanism 150, and the other end passing through a through-hole (or slot) formed on the locking mechanism 152. By this exemplary configuration, the restraining rail 184 serves as a stopping bar that is able to stop the target tissue 200 from entering into an area between the locking

mechanisms

The one end of the restraining rail 184 may be bonded to the tip of the locking mechanism 150 by an adhesive substance, heating or pressing process. The through-hole may be part of an opening of the locking mechanism 152, which is sized and shaped to permit the locking mechanism 150 to be received therein and also to permit the restraining rail 184 to be passed the through-hole.

As shown in FIG. 13B, when the clip unit 102 is drawn proximally toward the second configuration, in which the pair of clip arms 112 are closed to grip the target tissue 200, the restraining rail 184 passes through the opening of the locking mechanism 152, during which the target tissue 200 is prevented from being pinched by the locking

mechanisms

150 and 152 by the restraining rail 184. Once the locking

mechanisms

150 and 152 are engaged to one another, the restraining rail 184 is moved outside the clip unit 102.

The restraining rail 184 is made of a flexible and deformable material, and may be formed of any suitable biocompatible materials, such as, but not limited to, polymeric polymers and materials, including fillers such as metals, carbon fibers, glass fibers or ceramics, and combinations thereof. The metals may include cobalt chrome alloy, nickel titanium alloy, titanium, stainless steel, and the like. Useful, but non-limiting, polymeric materials include polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, polyvinyl acetate, polystyrene, polyethylene terephthalate), naphthalene dicarboxylatε derivatives, such as polyethylene naphthalate, polybutylene naphthalate, polytrimethylene naphthalate and trimethylenediol naphthalate, polyurethane, polyurea, silicone rubbers, polyamides, polycarbonates, polyaldehydes, natural rubbers, polyester copolymers, styrene-butadiene copolymers, polyethers, fully or partially halogenated polyethers, polyamidc/polyether polyesters, and copolymers and combinations thereof, and ABS (acrylonitrile butadiene styrene copolymer), PEEK (Poly Ether Ether Ketone), etc.

FIG. 14A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to another exemplary embodiment. FIG. 14B is a cross-sectional view taken line E-E of FIG. 14A.

In this modified exemplary embodiment, as shown in FIGS. 14A and 14B, a pair of restraining rails 186 each have one end attached to a corresponding side of the locking mechanism 150, and the other end passing through a corresponding through-hole of the locking mechanism 152. The other end of each of the pair of restraining rails 186 may pass through a groove formed on a corresponding side of the locking mechanism 152 and the second one of the pair of clip arms 112.

The one end of each of the restraining rails 186 may be bonded to the corresponding side of the locking mechanism 150 by an adhesive substance, heating or pressing process. The corresponding through-hole may be part of an opening of the locking mechanism 152, which is sized and shaped to permit the locking mechanism 150 to be received therein and also to permit the restraining rails 186 to be passed the through-hole. The groove may be sized and shaped to permit the restraining rails 186 to be passed through the locking mechanism 152 and the second one of the pair of clip arms 112.

The invention is not limited to have the pair of restraining rails 186. The invention may have one single restraining rail 186, which has its one end attached to one side of the locking mechanism 150, and its other end passing through a through-hole of the locking mechanism 152. The other end of the single restraining rail 186 may pass through a groove formed on one side of the locking mechanism 152 and the second one of the pair of clip arms 112.

The restraining rails 186 may be made of a flexible and deformable material, and may be formed of any suitable biocompatible materials, such as, but not limited to, polymeric polymers and materials, including fillers such as metals, carbon fibers, glass fibers or ceramics, and combinations thereof. The metals may include cobalt chrome alloy, nickel titanium alloy, titanium, stainless steel, and the like. Useful, but non-limiting, polymeric materials include polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, polyvinyl acetate, polystyrene, polyethylene terephthalate), naphthalene dicarboxylatε derivatives, such as polyethylene naphthalate, polybutylene naphthalate, polytrimethylene naphthalate and trimethylenediol naphthalate, polyurethane, polyurea, silicone rubbers, polyamides, polycarbonates, polyaldehydes, natural rubbers, polyester copolymers, styrene-butadiene copolymers, polyethers, fully or partially halogenated polyethers, polyamidc/polyether polyesters, and copolymers and combinations thereof, and ABS (acrylonitrile butadiene styrene copolymer), PEEK (Poly Ether Ether Ketone), etc.

FIG. 15A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to another exemplary embodiment. FIG. 15B is a cross-sectional view taken line E-E of FIG. 15A.

In this modified exemplary embodiment, as shown in FIGS. 15A and 15B, a groove 260 is formed at one side of each of the locking

mechanisms

150 and 152, and a restraining rail 188 has one end attached to the groove 260 of the one locking mechanism 150, and the other end passing through the groove 260 of the other locking mechanism 152.

The one end of the restraining rail 188 may be bonded to the groove 260 of the locking mechanism 150 by an adhesive substance, heating or pressing process. The groove 260 is sized and shaped to permit the restraining rail 188 to be passed through the locking mechanism 152 and the second one of the pair of clip arms 112.

The restraining rail 188 may be made of a flexible and deformable material, and may be formed of any suitable biocompatible materials, such as, but not limited to, polymeric polymers and materials, including fillers such as metals, carbon fibers, glass fibers or ceramics, and combinations thereof. The metals may include cobalt chrome alloy, nickel titanium alloy, titanium, stainless steel, and the like. Useful, but non-limiting, polymeric materials include polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, polyvinyl acetate, polystyrene, polyethylene terephthalate), naphthalene dicarboxylatε derivatives, such as polyethylene naphthalate, polybutylene naphthalate, polytrimethylene naphthalate and trimethylenediol naphthalate, polyurethane, polyurea, silicone rubbers, polyamides, polycarbonates, polyaldehydes, natural rubbers, polyester copolymers, styrene-butadiene copolymers, polyethers, fully or partially halogenated polyethers, polyamidc/polyether polyesters, and copolymers and combinations thereof, and ABS (acrylonitrile butadiene styrene copolymer), PEEK (Poly Ether Ether Ketone), etc.

FIG. 16 is a view schematically illustrating a clip unit with a restraining rail that is inserted into a channel of an endoscope according to an exemplary embodiment. FIG. 17 a view schematically illustrating a clip unit with a restraining rail that is in a first configuration according to an exemplary embodiment. As shown in FIGS. 16 and 17, in use, after the clip unit 102 has been loaded onto the applicator 104, the clip unit 102 in a closed configuration is disposed at the distal end of the sheath 108 and the pair of clip arms 112 projecting out of an open end 222 of the sheath 108 are closed. In this configuration, the clip unit 102 is inserted through a channel 230 of an insertion portion 240 of an endoscope (or any other insertion device) and inserted into the body (e.g., through a natural body lumen) to a site adjacent to a target portion of tissue to be clipped. The restraining rail 184 is connected to the locking

mechanisms

150 and 152, and is deformed to be disposed between the clip unit 102 and an inner surface of the channel 230. Once the insertion portion 240 arrives the side adjacent to the target portion to be clipped, the clip unit 102 is pushed out of a channel 230 through an endoscope tip 242, and the pair of clip arms 112 are opened for use.

FIG. 18 shows a side view of a distal portion of an additional exemplary embodiment of a clip device system related to the second embodiment. The clip delivery system 100 includes a clip unit 102 attached to distal end of an applicator 104. For example, clip unit 102 can be connected to a control member 110 via a connector 116. The control member 110 is movable within a plenum of the applicator 104 and manipulation of the control member 110, e.g., retracting and extending, moves the clip unit 102 to be withdrawn into at least a portion of the passage 10c or extended out from an opening at the distal end of the control member 110. A stop 56 serves to delimit the distance the clip unit 102 can move in the retracting direction.

As shown in FIG. 18, the clip unit 102 has two

clip arms

112a, 112b and the bases of the two

clip arms

112a and 112b are pivotable relative to each other about pivot connection 142a. In the embodiment shown, a groove or track 144 in the

clip arms

112a and 112b accommodates the movement of the

clip arms

112a and 112b as the

clip arms

112a and 112b move from the open position, i.e., the first configuration, to the closed position, i.e., the second configuration. Additionally, the clip unit 102 is pivotable and/or rotatable relative to the control member 110 about pivot connection 142b.

As with other embodiments disclosed herein, each

clip arm

112a and 112b includes locking mechanisms to lock the pair of

clip arms

112a and 112b when the clip unit 102 is in the closed tissue gripping configuration and the locking mechanisms includes corresponding mating features 150 and 152 (e.g., a pair of locking members - male lock feature 150 and female lock feature 15) for locking the clip arms 112 in the closed tissue gripping configuration. As with other embodiments disclosed herein, one of the

clip arms

112a and 112b also includes a restraining mechanism mounted on the

clip arms

112a and 112b. Specifically, the restraining mechanism includes restraining rail 184. Any of the embodiments disclosed herein for the locking mechanisms and restraining mechanism can be utilized in the clip unit 102 of the embodiment shown and described with respect to FIG. 18. In some embodiments, the clip unit 102 includes a restraining mechanism (such as the restraining rail 184 as shown in FIGS. 13A-13B, 14A-14B and 16-17 or the restraining rail 188 as shown in FIGS. 15A-15B). In other respects, such as other structural features, configuration and operation, the embodiments of the clip unit 102 and clip

arms

112a and 112b in FIG. 18 can be consistent with the structural features, configuration and operation for the second embodiments describe above with reference to FIGS. 13A to 17.

Third Embodiment
FIG. 19A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to a third exemplary embodiment. FIG. 19B is a side view schematically illustrating the clip unit of FIG. 19A. FIG. 19C is a side view schematically illustrating the clip unit of FIG. 19A when the clip unit is drawn into a sheath toward a second configuration. FIG. 19D is a side view schematically illustrating the clip unit of FIG. 19A when the clip unit is the second configuration.

In the third exemplary embodiment, the positions of the locking

mechanisms

150 and 152 are adjusted such that the locking

mechanisms

150 and 152 are disposed more proximally than those in the first and second exemplary embodiments, so that the

locking mechanism

150 and 152 are engaged to one another inside the sheath 108. By this adjustment, the open end 222 of the sheath 108 can serve the restraining mechanism, because the open end is sized and shaped such that the target tissue 200 cannot enter into the sheath 108 through the opening, thereby preventing the target tissue 200 from being pinched between the locking

mechanisms

150 and 152.

As shown in FIGS. 19A-19D, when the clip unit 102 is drawn proximally into the sheath 108, the pair of clip arms 112 are moved toward the closed configuration. Even if there is a portion of the target tissue 200 that projects in-between the locking

mechanisms

150 and 152, since the locking

mechanisms

150 and 152 are adjusted to engage one another inside the sheath 108, the portion of the target tissue 200 is blocked outside the sheath 108 by the open end 222.

FIG. 20A is a front view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened to receive a target tissue according to another exemplary embodiment, and FIG. 20B is a front view schematically illustrating a clip unit in a second configuration in which a pair of clip arms are closed to grip the target tissue.

As shown in FIGS. 20A1-20B2, the open end 222 of the sheath 108 includes a restraining member 190 (see FIGS. 20A2 and 20B1) that is a partition member equally dividing the open end 222 into a first opening 222a for the first one of the pair of clip arms 112 and a second opening 222b for the second one of the pair of clip arms 112. The first opening 222a is sized and shaped to permit the first one of the pair of clip arms 112 and the locking mechanism 150 to pass through the first opening 222a, and the second opening 222b is sized and shaped to permit the second one of the pair of clip arms 112 and the locking mechanism 152 to pass through the second opening 222b. By this configuration, even if there is a portion of the target tissue 200 that projects in-between the locking

mechanisms

150 and 152, since the locking

mechanisms

150 and 152 are adjusted to engage one another inside the sheath 108, the portion of the target tissue 200 is blocked outside the sheath 108 by the restraining member 190.

FIG. 20C1 is a front view schematically illustrating a clip unit in the first configuration according to a modified embodiment of FIG. 20A1. As shown in FIG. 20C2, the open end 222 of the sheath 108 includes two restraining members 191 and 192. The restraining member 191 is a bar-shaped member that extends inwardly from the open end 222 toward a center axis “O” of the open end 222. The restraining member 192 is also a bar-shaped member that extends inwardly from the open end 222 and faces the restraining member 191 without contacting the restraining member 191. By this configuration, even if there is a portion of the target tissue 200 that projects in-between the locking

mechanisms

150 and 152, since the locking

mechanisms

150 and 152 are adjusted to engage one another inside the sheath 108, the portion of the target tissue 200 can be blocked outside the sheath 108 by the restraining members 190 and 191.

The restraining member 190 may be integrally formed with the sheath 108, or may be bonded to the open end 222 by an adhesive substance, heating or pressing process. The restraining members 191 and 192 may also be formed integrally with the sheath 108, or be respectively attached to an inner surface of the open end 222 by an adhesive substance, heating or pressing process.

The restraining member 190 may be made of any suitable biocompatible materials, such as, but not limited to, polymeric polymers and materials, including fillers such as metals, carbon fibers, glass fibers or ceramics, and combinations thereof. The metals may include cobalt chrome alloy, nickel titanium alloy, titanium, stainless steel, and the like. Useful, but non-limiting, polymeric materials include polyethylene, polypropylene, polyvinyl chloride, polytetrafluoroethylene, fluorinated ethylene propylene copolymer, polyvinyl acetate, polystyrene, polyethylene terephthalate), naphthalene dicarboxylatε derivatives, such as polyethylene naphthalate, polybutylene naphthalate, polytrimethylene naphthalate and trimethylenediol naphthalate, polyurethane, polyurea, silicone rubbers, polyamides, polycarbonates, polyaldehydes, natural rubbers, polyester copolymers, styrene-butadiene copolymers, polyethers, fully or partially halogenated polyethers, polyamidc/polyether polyesters, and copolymers and combinations thereof, and ABS (acrylonitrile butadiene styrene copolymer), PEEK (Poly Ether Ether Ketone), etc.

FIG. 21 shows a side view of a distal portion of an additional exemplary embodiment of a clip device system related to the third embodiment. The clip delivery system 100 includes a clip unit 102 attached to distal end of an applicator 104. For example, clip unit 102 can be connected to a control member 110 via a connector 116. The control member 110 is movable within a plenum of the applicator 104 and manipulation of the control member 110, e.g., retracting and extending, moves the clip unit 102 to be withdrawn into at least a portion of the passage 10c or extended out from an opening at the distal end of the control member 110. A stop 56 serves to delimit the distance the clip unit 102 can move in the retracting direction.

As shown in FIG. 21, the clip unit 102 has two

clip arms

112a and 112b and the bases of the two

clip arms

112a and 112b accommodates the movement of the

clip arms

As with other embodiments disclosed herein, each

clip arm

112a and 112b includes locking mechanisms to lock the pair of clip arms when the clip unit 102 is in the closed tissue gripping configuration and the locking mechanisms includes corresponding mating features 150, 152 (e.g., a pair of locking members - male lock feature 150 and female lock feature 15) for locking the clip arms 112 in the closed tissue gripping configuration. Any of the embodiments disclosed herein for the locking mechanisms can be utilized in the clip unit 102 of the embodiment shown and described with respect to FIG. 21. In some embodiments, the clip unit 102 includes a locking mechanism as shown in FIGS. 19A-19D and 20A1-20B2 and does not include a retaining mechanism. In other respects, such as other structural features, configuration and operation, the embodiments of the clip unit 102 and clip

arms

112a and 112b in FIG. 18 can be consistent with the structural features, configuration and operation for the third embodiments describe above with reference to FIGS. 19A-19D and 20A1-20B2.

Fourth Embodiment
FIG. 22A is a side view schematically illustrating a clip unit in a first configuration in which a pair of clip arms are opened according to a fourth exemplary embodiment. FIG. 22B is a top view schematically illustrating the clip unit of FIG. 22A. FIG. 22C is a side view schematically illustrating the clip unit in a second configuration in which the pair of clip arms are closed. FIG. 22D is a top view schematically illustrating the clip unit of FIG. 22C.

In the fourth embodiment, as shown in FIGS. 22A and 22B, the clip unit 102 includes locking

mechanisms

154 and 156 that are disposed inside the sheath 108 and positioned more proximally than the open end 222 of the sheath 108. The sheath 108 includes a recess (notch) 224 extending proximally from the open end 222 and having a U-shape. The recess/notch 224 in this invention is not limited to the U-shape, and may be any shape and size that is suitable for the recess/notch 224 to receive the locking

mechanisms

154 and 156. The locking

mechanisms

154 and 156 are engaged with a groove 192 that is formed on each of the pair of clip arms 112. The

locking mechanism

154 and 156 each include a locking pin P that has a diameter larger than a width of the groove 192 so that the locking

mechanisms

154 and 156 is slidable along the groove 192 without coming off the pair of clip arms 112.

The groove 192 may be shaped as a taper extending narrowly in the distal direction, and includes a reduced diameter portion 194 at a distal end portion thereof. By this configuration, as shown in FIGS. 22C and 22D, when the clip unit 102 is drawn proximally, the locking pin P moves distally with respect to the pair of clip arms 112 and makes the locking

mechanisms

154 and 156 closer to each other. When the locking pin P arrives the reduced diameter potion 194, the locking pin P is locked at the reduced diameter portion 194 so as to prevent the locking

mechanisms

154 and 156 from moving with respect to the pair of clip arms 112.

Since the locking

mechanisms

154 and 156 are located inside the sheath 108 and more proximally than the open end 222 of the sheath 108, the target tissue 200 cannot enter into the sheath 108 because of the configuration of the open end 222 as described above. Thus, as the target tissue 200 is blocked by the open end 222 from entering into the sheath 108, the target tissue 200 can be prevented from being pinched between the locking

mechanisms

154 and 156.

Exemplary Methods
An exemplary method for loading the clip unit 102 housed within the cartridge 106 to the applicator 104 comprises inserting the control member 110 and/or the sheath 108 of the applicator 104 through the proximal opening 174 of the cartridge 106. The distal end 118 of the control member 110 is moved with respect to the cartridge 106 by, for example, moving the spool 124 distally against the connector 116 until a distal force of the distal end 118 against the connector 116 exceeds a predetermined threshold value, deforming the proximal opening 164 of the slot 160 of the connector 116 to permit the distal end 118 to pass therethrough into the space 166 of the connector 116. As the distal end 118 is moved distally with respect to the sheath 108, the spool 124 may slide distally over the positioning feature 128 of the handle member 122, providing tactile feedback to the user that the distal end 118 of the control member 110 has been extended distally past the distal end 136 of the sheath 108 to be coupled to the connector 116. Once the distal end 118 is received within the space 166, the connector 116 reverts to its original shape, holding the distal end 118 within the space 166. Upon coupling of the connector 116 and the control member 110, the clip unit 102 has been successfully loaded onto the applicator 104.

To remove the loaded clip unit 102 from the cartridge 106, the clip arms 112 are drawn proximally with respect to the sheath 108 of the applicator 104 to move the clip arms 112 toward the tissue gripping configuration, in which the restraining

members

181 and 182 contact and are deform by each other as shown in FIG. 9A or cross each other as shown in FIG. 11A. The spool 124 may be drawn proximally with respect to the handle member 122 until the spool 124 is drawn proximally of the positioning feature 128. As described above, an interior surface of the lumen 138 of the sheath 108 constrains the clip arms 112 as they are drawn into the lumen 138, to move the clip unit 102 toward the tissue gripping configuration. The clip unit 102 may then be drawn out of the cartridge 106 via the opening 174.

In use, after the clip unit 102 has been loaded onto the applicator 104, the clip unit 102 is inserted through the channel 230 (in FIG. 16) of an endoscope (or any other insertion device) and inserted into the body (e.g., through a natural body lumen) to a site adjacent to a target portion of tissue to be clipped. The clip unit 102 is inserted toward the target tissue 200 in the closed configuration to facilitate its passage through the channel 230. Upon reaching the site of the target tissue 200, the clip unit 102 is advanced out of the distal end 42 (in FIG. 17) of the channel 230 and the clip arms 112 are extended out of the sheath 108 of the applicator 104 to move the clip arms 112 toward the tissue receiving configuration by, for example, sliding the spool 124 distally over the handle member 122. Abutment of the distal surface 130 (in FIG. 6) of the spool 124 with the positioning feature 128 provides tactile feedback to the user, indicating that the clip arms 112 are at the maximum open configuration, and that moving the spool 124 any further distally would result in the connector 116 extending distally out of the sheath 108.

The clip arms 112 may be repeatedly moved between the tissue receiving and the tissue gripping configurations (the first and second configurations) until a target portion of tissue is received between the distal ends 140 of the clip arms 112, as desired. Once the target portion of tissue is received between the clip arms 112, the clip unit 102 is moved toward the tissue gripping configuration by moving the control member 110 proximally relative to the clip unit 102. At this time, the restraining member 180 is also activated to prevent the target portion of tissue from being pinched between the locking

mechanisms

150 and 152 as described in the first through fourth embodiments.

When it is confirmed that the desired portion of tissue is gripped between the clip arms 112 (e.g., portions of tissue on opposite sides of a bleeding wound), the control member 110 is drawn further proximally relative to the clip unit 102 (via the spool 124) to lock the clip unit 102 in the closed configuration. That is, the clip arms 112 are drawn further proximally into the sheath 108 until the locking

mechanisms

150 and 152 engage one another, locking the clip arms 112 relative to one another. The control member 110 is drawn proximally with respect to the locking sheath 108 until the connector 116 comes into contact with and abuts the shoulder 176 of the lumen 138 of the sheath 108. The shoulder 176 prevents the connector 116 from moving proximally there past while a continued proximal force is exerted on the control member 110.

When the distal end 118 of the control member 110 exerts a force on the connector 116 beyond a predetermined threshold value, the connector 116 deforms (e.g., the proximal opening 164 expands) to permit the distal end 118 to be released from the longitudinal slot 160. Once the distal end 118 is released from the connector 116, the applicator 104 may be withdrawn from the living body, leaving the clip unit 102 including the restraining member 180 in the body over the target tissue. If so desired, a new clip unit 102 including the restraining member 180 is then loaded onto the applicator 104, in the same manner as described above, so that the device may then be used to clip a second portion of tissue. This process may be repeated using the same applicator 104 as many times as needed or desired.

The invention is not limited the above-described embodiments including connecting configurations between the clip unit 102 and the applicator 104. FIG. 23 is a perspective view schematically illustrating another connecting configuration in which an applicator of an endoscope to be used in combination with a clip unit according to one exemplary embodiment. FIG. 24 is a perspective view schematically illustrating the clip unit to be used in combination with the applicator of FIG. 23.

As shown in FIG. 23, an applicator 10 is a unit for inserting into an abdominal cavity (a control unit), and may include an insertion tube 20, a control wire 30, and a control unit 40. The applicator 10 is used in combination with a clip unit 60, for example, by inserting into a surgical tool insertion channel (not shown) of an endoscope. Therefore, the insertion tube 20 includes a distal end tip 21, a distal end coil 22, and a proximal end coil 24. The control wire 30 includes a hook unit 31 at the distal end of the applicator 10 and wire 32. The control unit 40 includes a control unit main body 41, a slider 42, a supporter 47, and a thumb ring 48. The main body 41 includes a slit 41a and a grip 41b. The slider 42 includes a first slide member 51 and a second slide member 52 with a slit 52b.

As shown in FIG. 24, a clip unit 60 is configured to be fit to the hook unit 31. The clip unit 60 may include a clip 61, a connection member 62, and a constraining pipe 63 as a tightening member. The clip 61 may have a loop (base) 61a made by bending a metallic plate material such as a flat spring made of stainless steel, for example, at substantially a central part. The clip 61 is crossed in vicinity of the loop 61a, and extended as a pair of clip arms 61b having an expanding characteristic in the state that the distal ends are separated. A tissue grasping part (a clip claw) 61c is formed at the end of the clip 61.

The crossing part of the arms 61b of the clip 61 is made narrower than the distal end side, and the tissue grasping parts 61c are opposed to each other. The clip 61 can slide on the inner surface of the constraining pipe 63 when moving the clip 61 in the direction of pulling into the pipe 63, but the clip 61 is engaged in the inner surface of the pipe 63 when moving the clip 61 in the direction reverse to the pulling-in direction.

The connection member 62 is formed by injection molding out of strong resin such, as liquid crystal polymer and polyamide synthetic fiber, for example. The connection member 62 is a cylindrical bar, and is engaged with the clip 61 inside the constraining pipe 63.

The connection member 62 includes a stopper projection 62i connected to the constraining pip 63, and the proximal end of the connection member 62 is forked into two branches that include a cutout 62d and an elastic arm 62e. The two branches are configured to receive the end of the arrowhead hook unit 31.

The constraining pipe 63 is formed by injection molding of rigid resin having appropriate elasticity, such as a material more flexible than the clip 61, for example, polyphthalamide (PPA) and polyamide (PA). By fitting the pipe 63 to the arms 61b of the clip 61, the arms 61b of the clip 61 are closed. The constraining pipe includes a pair of wings 63d elastically retractable in the radial direction is formed.

While preferred embodiments of the invention have been described and illustrated above, it should be understood that these are exemplary of the invention and are not to be considered as limiting. Additions, omissions, substitutions, and other modifications can be made without departing from the spirit and scope of the present invention. Accordingly, the invention is not to be considered as being limited by the foregoing description, and is only limited by the scope of the appended claims

While various embodiments of the disclosed technology have been described above, it should be understood that they have been presented by way of example only, and not of limitation. Likewise, the various diagrams may depict an example schematic or other configuration for the disclosed technology, which is done to aid in understanding the features and functionality that can be included in the disclosed technology. The disclosed technology is not restricted to the illustrated example schematic or configurations, but the desired features can be implemented using a variety of alternative illustrations and configurations. Indeed, it will be apparent to one of skill in the art how alternative functional, logical or physical locations and configurations can be implemented to implement the desired features of the technology disclosed herein.

Although the disclosed technology is described above in terms of various exemplary embodiments and implementations, it should be understood that the various features, aspects and functionality described in one or more of the individual embodiments are not limited in their applicability to the particular embodiment with which they are described, but instead can be applied, alone or in various combinations, to one or more of the other embodiments of the disclosed technology, whether or not such embodiments are described and whether or not such features are presented as being a part of a described embodiment. Thus, the breadth and scope of the technology disclosed herein should not be limited by any of the above-described exemplary embodiments.

Terms and phrases used in this document, and variations thereof, unless otherwise expressly stated, should be construed as open ended as opposed to limiting. As examples of the foregoing: the term “including” should be read as meaning “including, without limitation” or the like; the term “example” is used to provide exemplary instances of the item in discussion, not an exhaustive or limiting list thereof; the terms “a” or “an” should be read as meaning “at least one,” “one or more” or the like; and adjectives such as “conventional,” “traditional,” “normal,” “standard,” “known” and terms of similar meaning should not be construed as limiting the item described to a given time period or to an item available as of a given time, but instead should be read to encompass conventional, traditional, normal, or standard technologies that may be available or known now or at any time in the future. Likewise, where this document refers to technologies that would be apparent or known to one of ordinary skill in the art, such technologies encompass those apparent or known to the skilled artisan now or at any time in the future.

The presence of broadening words and phrases such as “one or more,” “at least,” “but not limited to” or other like phrases in some instances shall not be read to mean that the narrower case is intended or required in instances where such broadening phrases may be absent.

　　Additionally, the various embodiments set forth herein are described in terms of exemplary schematics, block diagrams, and other illustrations. As will become apparent to one of ordinary skill in the art after reading this document, the illustrated embodiments and their various alternatives can be implemented without confinement to the illustrated examples. For example, block diagrams and their accompanying description should not be construed as mandating a particular configuration.

(Chapter 2)
Reference is made to the attached drawings, wherein elements having the same reference numeral designations represent similar elements throughout.

Throughout all of the drawings, dimensions of respective constituent elements are appropriately adjusted for clarity. For ease of viewing, in some instances only some of the named features in the figures are labeled with reference numeral.

Clips of the present disclosure are useful in therapeutic procedures of a patient such as to prevent tissue bleeding, closing perforations and hemostasis, and suture contraction of an inner wound, marking lesions and traction (mucosal elevation) and other surgical procedures. Generally a clip device for grasping tissue of a patient includes a clip that can be actuated by a wire configured in a sheath in which the wire can advance and retract longitudinally within the sheath by operating a handle of the device. References herein to the term “distal” are to a direction away from the operating handle, while references to the term “proximal” are to a direction towards the operating handle. For example, US 2019/0104926, which is incorporated by reference herein, discloses an endoscope treatment tool having clips that can lock. The term “patient,” as used herein, comprises any and all organisms and includes the term “subject.” A patient can be a human or an animal.

FIG. 25 schematically illustrates a clip device 1100 configured to lock a clip by pulling a wire in a single operation. As shown, such a device includes a clip 1110 having

arms

1112, and 1113, for grasping tissue and

claws

1112a, and 1113a at distal ends of the

arms

1112, and 1113, respectively. The device further includes a wire 1111 connected to a proximal end of the clip 1110 and configured to reciprocally move within a sheath (not shown) and a tube or pipe 1114 connected to a distal end of a sheath (not shown)(the terms “tube” and “pipe” are used interchangeably herein). During operation,

arms

1112 and 1113, which are biased toward an open, tissue receiving configuration, can be deployed from pipe 1114 and retracted into pipe 1114 by reciprocally moving wire 1111. For example, as the wire 1111 is pulled proximally, arms of the clip 1110 are drawn into the pipe 1114 so that contact with the pipe 1114, such as contact with edges forming the opening of the pipe 1114, draws distal ends of the arms toward one another to close the clip arms and, as the wire is pushed distally, arms of the clip 1110 are deployed from the pipe 1114 so that distal ends of the arms move away from one another due to the natural bias of the

arms

1112, and 1113 to be in an open state. Hence, the

arms

1112, and 1113 of the clip 1110 can be reciprocally (R) closed and opened by reciprocally moving the wire 1111 connected to the clip 1110 proximally or distally.

As further illustrated in FIG. 25, the clip 1110 includes a latch part 1115 protruding on an outer surface of at least one arm and a corresponding a latch part 1117 at a proximal end of pipe 1114 such that when the wire 1111 is pulled proximally, the latch part 1115 moves from a distal surface 1117a to a proximal surface 1117b of corresponding the latch part 1117 of the pipe 1114 to lock the clip 1110 in a closed state. Such a configuration allows the wire 1111 to close the

clip arms

1112, and 1113 and lock the clip 1110 in a single operation by simply pulling the wire 1111 proximally without interruption. However, users of such a clip device 1100 can unintentionally lock the clip 1110 when operating the wire 1111 during a therapeutic procedure.

An advantage of the present disclosure includes a device, e.g., treatment tool, that includes a clip 1110 that can be reciprocally closed and opened in one operation and locked in a separate operation, distinct from the operation of reciprocally closing and opening the clip 1110, thereby minimizing unintended locking of the clip 1110 while operating the device. For example, the clip 1110 can be locked by an operation other than operating the wire 1111 to close and open the clip 1110 such as by operating a stopper or by operating a control member reciprocally movable within the sheath to slid over the

clip arms

1112 and 1113 or to slid a locking ring over the

clip arms

1112, and 1113. Various embodiments and aspects of a clip device 1100 according to the present disclosure will be described with references to FIGS. 26A through 34B.

FIGS. 26A-27D4 schematically illustrate a clip device with one or more latch elements on a

clip arm

1112 and 1113 configured to lock the clip in a closed state by slidably moving a locking ring over the one or more latch elements with a control member in accordance with aspects of the present disclosure. For example, and as shown in FIGS. 26A, 26B, 26C and 26D, a clip device 1200 can include clip 1210 and wire 1211 connected to a proximal end of the clip 1210 and configured to reciprocally move within coil sheath 1216 to retract and deploy clip 1210 from pipe 1214 disposed at a distal end of sheath 1216 to close and open the clip 1210. The arms of such a clip 1210 are biased toward an open, tissue receiving configuration. A proximal end of the wire 1211 is connected to and operated by a slider 1234 housed on handle 1230. The slider 1234 can reciprocally move the wire 1211 within the coil sheath 1216 to retract and deploy clip 1210 from pipe 1214.

In this example, the device further includes a locking ring 1224 housed in the coil sheath 1216 and a control member, e.g., an inner sheath 1226, reciprocally movable within the coil sheath 1216 by reciprocal operation of a control knob 1228. The clip 1210 further includes a latch element 1220 protruding therefrom and also includes the projection 1222 at a distal end region of at least one arm of the clip. As shown in FIGS. 26A-26B, the clip 1210 can be drawn into pipe 1214 to close the clip arms 1112 and 1113and also clip 1210 can be deployed from the pipe 1214 to open the

clip arms

1112 and 1113 by operation of the wire 1211 through the slider 234 without locking the clip 1210. For this example, the wire 211 is configured to reciprocally move within the control member, e.g., the inner sheath 1226. The projection 1222 limits the clip 1210 from moving too far proximally in the pipe 1214 as shown in FIG. 26B. Thus a separate operation is needed to lock the clip 1210.

As shown in FIGS. 26A-26D, the locking ring 1224 is configured to slidably move over the latch element 1220 and be disposed between the pipe 1214 and the latch 1220 in an axial direction to lock the clip 1210 in the pipe 1214. As shown in FIG. 26C, while the clip 1210 is retracted within the pipe 214 and is in a closed state, the locking ring 1224 can be pushed distally over the latch element 1220 by sliding the control member 1226 distally with the control knob (1228). Once the locking ring 1224 is pushed distally over the latch element 1220, arms of the clip 1210 are locked in a closed state and cannot be readily opened. Once the clip 1210 is locked, the clip 1210 and the pipe 1214 can be disconnected from the coil sheath 1216 as shown in FIG. 26D. Certain clip devices can include a link mechanism that can engage and release a pipe from the sheath such as in a QuickClip pro (QCP) clip having a connection member (not shown). See, e.g., U.S. 9,949,740, which is incorporated herein by reference. Such devices include a connection member to engage and disengage a distal end of the clip 1210 from the wire 1211.

In another example, FIGS. 27A, 27B, and 27C schematically illustrate a clip device 1300 with latch elements on clip arms and a locking ring having complementary mating portions to the latch elements which lock the ring to the latch elements and lock the clip in a closed state in accordance with aspects of the present disclosure. As shown in FIGS. 27A, 27B and 27C, the clip device includes the clip 1310 including a first arm 1312, and a second arm 1313, which are biased toward an open, tissue receiving configuration, and

claws

1312a, 1313a, at distal ends of the

arms

1312 and 1313, respectively. In addition, the first arm 1312 of the clip 1310 has a first latch element 1320a and the second arm 1313 has a second latch element 1320b. A wire 1311 is connected to a proximal end of the clip 1310 and configured to reciprocally move within the coil sheath 1316. A slider 1334 housed on a handle 1330 is connected to a proximal end of the wire 1311 to operate the wire 1311.

In this example, a tube 1340 is disposed at a distal end of the sheath 1316. The tube 1340 can be a pipe, which can be disconnectable from the sheath 1316, or fixed onto the sheath 1316 without being able to be disconnected from the sheath 1316. In additional embodiments, the tube 1340 is integral with the sheath 1316 and constitutes a distal end region of the sheath 1316. An integrally formed tube 1340 is stiffer than the sheath 1316 so that the distal end provides a sufficiently rigid bearing surface to interact with the

arms

1312 and 1313 and cause them to move toward each other when the

clip arms

1312 and 1313 are drawn into the distal end region. For example, the distal end region does not expand when the clip arms 312 and 313 are drawn into the distal end region. The device further includes a locking ring 1324 located at a distal end of the tube 1340 and a control member, e.g., an inner sheath 1326, reciprocally movable within the coil sheath 1316 by operation of a control knob 1328. The locking ring 1324 can be held in place by the

clip arms

1312 and 1313 which are biased in an open state and which can apply a constant force against the locking ring 1324 toward the distal end of the sheath 1316.

As shown in FIGS. 27A-27B, the clip 1310 can be drawn into the tube 1340 to close the

clip arms

1312 and 1313 and can also be deployed from the tube 1340 to open the

clip arms

1312 and 1313 by operation of the wire 1311, which is configured to reciprocally move within the control member through the slider 1334 without locking the clip 1310. In a separate operation, as shown in FIG. 27C, while the clip 1310 is retracted within the tube 1340 and is in a closed state, the locking ring 1324 can be pushed distally over the

latch elements

1320a and 1320b by sliding the control member 1326 distally with the control knob 1328. Once the locking ring 1324 is pushed distally over the

latch elements

1320a and 1320b, the clip arms 1312and 1313 of the clip 1310 are locked in a closed state and cannot be readily opened. In addition, the

latch elements

1320a and 1320b can have complementary mating portions to the locking ring 1324 which lock the locking ring 1324 to the one or

more latch elements

1320a and 1320b thereby locking the clip 1310. FIGS. 27D1-27D4 illustrates three different examples of the latch elements 1320 on the

clip arms

1312 and 1313 of the clip 1310, and a complementary mating portions 1350 on locking rings 324.

FIGS. 28A-28D schematically illustrate another example of a clip device 1400 in which different structural elements are used to lock the clip and to close and open the clip. As shown in FIGS. 28A, 28B, and 28C, the clip device 1400 includes a clip 1410 and a wire 1411 connected to a proximal end of the clip 1410 and configured to reciprocally move within a coil sheath 1416. The clip 1410 includes a first arm 1412, and a second arm 1413, which are biased toward an open, in a tissue receiving configuration, and

claws

1412a and 1413a, at distal ends of the

arms

1412 and 1413, respectively. The wire 1411 is operated by a slider 1434 housed on a handle 1430 and the slider 1434 is connected to a proximal end of the wire 1411. A tube 1440 is connected to a distal end of the sheath 1416. In this example, the tube 1440 is fixed onto the sheath 1416 without being configured to disconnect from the sheath 1416. In alternative embodiments, the tube 1440 can be a separate element attached to the sheath 1416 or can be integrally formed with the sheath 1416, i.e., as a distal end region of the sheath 1416.

As shown in FIGS. 28A and 28B, the clip 1410 can be drawn into the tube 1440 to close the

clip arms

1412 and 1413 and also can be deployed from the tube 1440 to open the clip arms 1412 and 413 by operation of the wire 1411 through the slider 1434 without locking the clip 1410. In this example, the clip 1410 includes a first arm 1412 which has a first latch element 1420a and a second arm 1413 which has a second latch element 1420b. The first and

second latch elements

1420a and 1420b, oppose each other and are configured to engage each other and lock when pressed together. As shown in FIG. 28C, while the clip 1410 is retracted within the tube 440 and is in a closed state, the control member, e.g., the inner sheath 1426, can be slid distally with the control knob 1428 over the

clip arms

1412 and 1413, to press and lock the first and

second latch elements

1420a and 1420b together. Once the inner sheath 1426 is pushed distally over the

latch elements

1420a and 1420b, the

latch elements

1420a and 1420b engage to lock the

arms

1412 and 1413 of the clip 1410. Once locked, the

arms

1412 and 1413 cannot be readily opened. Once the clip 1410 is locked, the clip 1410 itself can be disconnected from the wire 1411 as shown in FIG. 28D. In this example, no pipe is released when the clip 1410 is released from the sheath 1416.

FIGS. 29A-29D schematically illustrate another example of a clip device in which operating a wire does not lock the clip in a closed state in a single operation. As shown in FIGS. 29A, 29B, 29C, and 29D, a clip device 1500 includes a clip 1510, a wire 1511 connected to a proximal end of the clip 1510 and configured to reciprocally move within a sheath 1516, and a pipe 1514 connected to a distal end of the sheath 1516. The wire 1511 is operated by a slider 1534 housed on a handle 1530 and the slider 1534 is connected to a proximal end of the wire 1511. The clip device 1500 further includes a control member, e.g., an inner sheath 1526, reciprocally movable within the sheath 1516 by operation of a control knob 1528. A stopper 1550 is connected to a distal end region of the wire 511.

As further illustrated in FIG. 29A-29B, the clip 1510 includes a latch part 1520 protruding on an outer surface of at least one arm of the clip 1510 and a corresponding latch part 1517 at a proximal end of the pipe 1514. However, the wire 1511, a stopper 1550, and the inner sheath 1526 are configured to prevent locking of the clip, e.g., by pulling the latch part 1520 past corresponding the latch part 1517 such that the protruding latch part 1520 engages with the corresponding latch part 1517 to prevent movement of the clip 1510 in a distal direction, in a single operation by simply pulling the wire proximally without interruption.

As shown in FIG. 29B, the stopper 1550 is configured to abut a distal end 1526a of the inner sheath 1526 when the clip 1510 is in a closed state and when the inner sheath 1526 is positioned distally. Such a configuration prevents the wire 1511 from locking the clip 1510 when the wire 1511 and the slider 1534 are pulled proximally to close clip 1510 in the pipe 514. Such a configuration prevents a user from unintentionally locking the clip 1510 when closing the clip 1510 during operating the device.

As shown in FIGS. 29C-29D, the inner sheath 1526 is configured to move proximally by operating knob 1528. When positioned proximally, the inner sheath 1526 allows the stopper 1550 to move proximally when further moving the wire 1511 and the slider 1534 proximally. After moving the inner sheath 1526 proximally, a user can move the wire 1511 proximally such that when the wire 1511 is pulled proximally the latch part 1520 moves from a distal surface 1517a to a proximal surface 1517b of the corresponding latch part 1517 of the pipe 1514 to lock the clip 1511 in a closed state.

FIGS. 30A-34B illustrate other stopper configurations with clip devices according to aspects of the present disclosure. Such stopper configuration can be included with one or more features of devices illustrated in FIGS. 26A-29D.

For example, FIGS. 30A-33B illustrate a clip 1610, including a first arm 1612, having a first latch element 1620a, a second arm 1613 having a second latch element 1620b, and a wire 1611 connected to a proximal end of the clip 1610 and configured to reciprocally move within a coil sheath 1616. The

clip arms

1612 and 1613, further include

claws

1612a and 1613a, at distal ends of the

clip arms

1612 and 1613. During operation, the

clip arms

1612 and 1613, which are biased toward an open, in a tissue receiving configuration, can be deployed from and retracted into a tube or pipe by reciprocally moving the wire 1611. The device further includes a control member, e.g., an inner sheath (626 or 826), and the locking ring 1624 which can be slid over the

latch elements

1620a and 1620b of the

clip arms

1612 and 1613 by operation of the inner sheath 1626. A slider 1634 is connected to a proximal end of the wire 1611 to operate the wire 1611.

As further shown in the example of FIGS. 30A-30B, the clip device 1600 includes a handle 1630 connected to a proximal end portion of the sheath 1616. The handle 1630 in this example includes a main body 1635. The main body 1635 is in the form of a bar shape extending in the axial direction Y having a finger hooking part 1636 at the proximal end region of the main body 1635 and a slit 1632 extending in the axial direction Y.

In this device, a removable stopper 1650 is included in the slit 1632 at a proximal end of the slit 1632 to prevent the slider 1634 from reaching the proximal end of the slit 1632 when the stopper 1650 is in place. In such a configuration, the clip 1610 cannot be inadvertently locked by pulling the slider 1634 to close the clip 1610. Additional operations are needed to lock the clip 1610 in a closed state for the configuration of this example, which include removing the stopper 1650 and moving the inner sheath 1626 to push the locking ring 1624 distally over the

latch elements

1620a and 1620b. Once the locking ring 1624 is pushed distally over the

latch elements

1620a and 1620b, the

clip arms

1612 and 1613 of the clip 1610 are locked in a closed state and cannot be readily opened.

FIGS. 31A, 31B, and 31C schematically illustrate another clip device 1700 including a stopper structure in accordance with aspects of the present disclosure. As shown, a stopper 1750 is a restraining device that is reversibly connected to a knob 1628 and extends to a proximal length of where the slider 1634 moves proximally to close the clip 1610. When the stopper 1750 is connected to the knob 1628, the stopper 1750 prevents an inner sheath 1626 from moving distally to lock the clip 1610 when the clip 1610 in in a closed state as shown in FIG. 31B. To lock the clip 1610, the stopper 1750 is released from the knob 1628 and the knob 1628 and inner sheath 1626 are moved distally to push the locking ring 1624 over the

latch elements

1620a and 1620b.

FIGS. 32A1-32B schematically illustrate another clip device 1800 including a stopper and inner sheath structure in accordance with aspects of the present disclosure. As shown in this example, a stopper 1850 is connected to a distal end region of a wire 1611. An additional stopper 1851 is housed in and connected to a sheath 1616 at a location proximal to the stopper 1850 on the wire 1611. The stopper 1851 connected to the sheath 1616 can have a port 1851a, typically in a center of a cross-section, to allow the wire 1611 to reciprocally move through the stopper 1851 and ports 1851b, typically off-center, to allow the inner sheath 1826 to reciprocally translate through the stopper 1851. As shown in FIG. 32A3, the inner sheath 1826 is configured to have extending portions 1826a to translate past stopper 1851 and push the locking ring 1624 over the

latch elements

1620a and 1620b when locking the clip 1610. As further shown in FIG. 32B, when the wire 1611 is moved proximally by the slider 624 to close the

clip arms

1612 and 1613, the stopper 1850 abuts the additional stopper 1851 in the sheath 1616 preventing the clip 1610 from inadvertently being locked. To lock the clip 1610, the inner sheath 1826 is pushed through the additional stopper 1851, e.g., though one or more ports 1851b, to push the locking ring 1624 over the

latch elements

1620a and 1620b.

FIGS. 33A and 33B schematically illustrate another clip device 1900 including stopper structures in accordance with aspects of the present disclosure. As illustrated in this example, the device includes a stopper 1950 connected to the wire 1611 located at a proximal region of the wire 1611 and stoppers 1951a and 1951b on the inner sheath 1626. The stoppers 1951a and 1951b project inward relative to the inner surface of the inner sheath 1626. For this example, the stoppers 1951a and 1951b on the inner sheath 1626 are located at the knob 1628. Further, the inner stoppers 1951a and 1951b are configured in a spaced-apart relation to allow the wire 1611 to translate through a space between the inner stoppers 1951a and 1951b. However, the size of the space is less than a size of the stopper 1950 such that, when translated proximally by the wire 1611, the stopper 1950 abuts the inner stoppers 1951a and 1951b and is stopped from further moving in the proximal direction. However, the wire stopper 1950 can translate through the space between the inner stoppers 1951a and 1951b with sufficient force applied to the wire 1611, which may assist in assembly of the wire 1611 in the clip device 1900. In some embodiments, at least a portion of one or both of the stopper 1950 and the inner stoppers 1951a and 1951b can be made of resilient material, such as rubber.

FIGS. 34A and 34B schematically illustrate another clip device 2000 including a stopper in accordance with aspects of the present disclosure. As shown in this example, clip 2010 includes two opposing protrusions facing each other. The clip 2010 includes a first arm 2012 with a first inner protrusion 2050a, a second arm 2013 with a second inner protrusion 2050b, in which the protrusions are on inner surfaces of the

arms

2012 and 2013 and face each other. The tube or pipe in this example further includes a pin 2051 configured to abut the

protrusions

2050a and 2050b on the

clip arms

2012 and 2013 when the clip 2010 is retracted in the tube or pipe. The interaction of the

protrusions

2050a and 2050b with the pin 2051 limits the distance that the clip 2010 can retract into the tube or pipe. In such a configuration, the clip 2010 cannot be inadvertently locked by pulling the wire 1611 to close the clip 2010. Rather, to lock the clip 2010, the inner sheath 1626 is pushed in the distal direction to move the locking ring 1624 distally over the

latch elements

1620a and 1620b

As illustrated by the various examples, a clip device can be operated by closing a clip having a first arm and second arm biased in an open state and having one or more latch elements by pulling a wire connected to a proximal end of the clip to retract the clip in a tube or pipe in one operation. In a second operation, the clip can be locked in a closed state by moving a stopper or by an operation other than pulling the wire to close the clip. For example, locking the clip can be carried out by sliding a locking ring distally over the one or more latch elements or by sliding an inner sheath over the clip arms to lock mating latch elements on the clip arms.

While the claimed invention has been described in detail and with reference to specific embodiments thereof, it will be apparent to one of ordinary skill in the art that various changes and modifications can be made to the claimed invention without departing from the spirit and scope thereof. Thus, for example, those skilled in the art will recognize, or be able to ascertain, using no more than routine experimentation, numerous equivalents to the specific substances and procedures described herein. Such equivalents are considered to be within the scope of this invention, and are covered by the following claims.

The present disclosure can be applied to improve mechanism for locking the clip arms of the clip device which substantially obviate one or more of the issues due to limitations.

The present disclosure can be applied to be used with endoscopes which can minimize locking of clips when not intended.

10, 104 Applicator (Clip device)
108, 1216, 1316, 1416, 1516, 1616 Sheath
112 Clip arm
138 Lumen
150, 152, 154, 565 Locking mechanism (Stopping bar)
181 First restraining member (Restraining mechanism, Stopping bar, Curved bar)
182 Second restraining member (Restraining mechanism, Stopping bar, Curved bar)
150, 152 Mating Feature (First locking member, Second locking member)
184, 186, 188 Restraining rail (First restraining rail, Second restraining rail)
194 Reduced diameter portion
190 Restraining member (Partition member)
1100, 1200, 1300, 1400, 1500, 1600, 1700, 1800, 1900, 2000, Clip device
1110, 1210, 1310, 1410, 1510, 1610 Clip
1111, 1211, 1311, 1411, 1511, 1611 Wire
1220, 1320, 1320a, 1320b, 1420, 1420a, 1420b, 1620a, 1620b Latch element
1224, 1324, 1624 Locking ring
1222 Projection
1312, 1313, 1412, 1413, 1512, 1513, 1612, 1613 Clip arm
1340, 1440 Tube
1350 Mating portion
1226, 1326, 1426, 1526, 1626, 1826 Inner sheath
1550, 1650, 1750, 1850, 1851 Stopper
1230, 1330, 1430, 1530, 1630 Handle
1635 Main body
1632 Slit

Claims

A clip device comprising:
　　　　a sheath including a lumen and at least one open end;
　　　　a plurality of clip arms movable between a first configuration in which the plurality of clip arms are opened to receive a target tissue, and a second configuration, in which the plurality of clip arms are closed to grip the target tissue;
　　　　locking mechanisms respectively provided on the plurality of clip arms to engage one another for maintaining the second configuration; and
　　a restraining mechanism configured to be associated with the locking mechanisms to prevent the target tissue from being pinched between the locking mechanisms.
The clip device according to claim 1,
　　wherein the plurality of clip arms includes a first arm and a second arm; and the locking mechanisms are respectively disposed on inner surfaces of the first and second clip arms.
The clip device according to claim 2,
　　wherein the restraining mechanism includes a first restraining member and a second restraining member, distal end portions of which are respectively positioned more distally than the locking mechanisms.
The clip device according to claim 3,
　　wherein the first restraining member and the second restraining member contact each other and are deformed to extend distally in the second configuration, thereby pushing the target tissue away from the locking mechanisms.
The clip device according to claim 3,
　　wherein the first restraining member and the second restraining member cross each other in the second configuration and are each configured as a stopping bar to prevent the target tissue from being pinched between the locking mechanisms.
The clip device according to claim 4,
　　wherein the first restraining member and the second restraining member are each configured as a curved bar having a protection front end surface.
The clip device according to claim 1,
　　wherein the locking mechanisms includes a first locking member and a second locking member, and
　　wherein the restraining mechanism includes a restraining rail having one end attached to the first locking member and the other end passing through a through-hole formed in the second locking member.
The clip device according to claim 7,
　　wherein the through-hole is part of an opening of the second locking member, and the opening of the second locking member is configured to receive the first locking member.
The clip device according to claim 1,
　　wherein the locking mechanisms includes a first locking member and a second locking member,
　　wherein the restraining mechanism includes a first restraining rail and a second restraining rail, and
　　wherein the first and second restraining rails have respective end portions attached to respective side surfaces of the first locking member, and pass through a through-hole formed in the second locking member.
The clip device according to claim 9,
　　wherein the through-hole is part of an opening of the second locking member, and the opening of the second locking member is configured to receive the first locking member.
The clip device according to claim 1,
　　wherein the locking mechanisms includes a first locking member and a second locking member,
　　wherein the restraining mechanism includes at least one restraining rail, and
　　wherein the at least one restraining rail has an end portion attached to a first side surface of the first locking member, and is movable along a second side surface of the second locking member.
The clip device according to claim 1,
　　wherein the locking mechanisms includes a first locking member and a second locking member,
　　wherein the restraining mechanism includes a restraining rail, and
　　wherein the restraining rail has one end attached to a groove formed on the first locking member, and is movable along a groove formed on the second locking member.
The clip device according to claim 1,
　　wherein the locking mechanism is drawn into the sheath in the second configuration, and
　　wherein an open end of the sheath serves as the restraining mechanism.
The clip device according to claim 13,
　　wherein the open end of the sheath includes at least one restraining member that extends inwardly from the open end toward a center axis of the sheath.
The clip device according to claim 1,
　　wherein the sheath includes a recess extending proximally from the open end of the sheath for accommodating the locking mechanisms, and
　　wherein the plurality of clip arms each include a groove that is configured to engage with the locking mechanisms such that the locking mechanisms is able to slidably move along the groove with respect to the plurality of clip arms.
The clip device according to claim 15,
　　wherein the groove includes a reduced diameter portion formed at a distal end portion of the groove, and
　　wherein the locking mechanisms each include a locking pin that is configured to engage with the reduced diameter portion so as to prevent the locking mechanisms from moving with respect to the plurality of clip arms.
The clip device according to claim 14,
　　wherein the open end of the sheath includes one additional restraining member that extends inwardly from the open end, and faces toward the at least one restraining member.
The clip device according to claim 13,
　　wherein the open end of the sheath includes a partition member that divides the open end into a first opening and a second opening.
The clip device according to claim 1, wherein the restraining mechanism and the locking mechanisms are provided on a first arm of the plurality of clip arms,
　　wherein the restraining mechanism extends a first distance in a first direction away from the first arm and the locking mechanisms extends a second distance in the first direction away from the first arm, and
　　wherein the first distance is greater than the second distance.
The clip device according to claim 2,
　　wherein the restraining mechanism includes a first restraining member and a second restraining member and the locking mechanisms include a first locking member and a second locking member, and
　　wherein, in the first configuration, a first distance between the first restraining member and the second restraining member is less than a second distance between first locking member and the second locking member.
A clip device comprising:
　　a clip having a first arm and second arm in which the first arm and second arm are configured to move in a direction toward and away from each other to close and open the clip;
　　a wire connected to a proximal end of the clip configured to reciprocally move within a sheath to close and open the clip;
　　one or more latch elements on the clip configured to lock the clip in a closed state;
　　wherein operating the wire cannot lock the clip in a closed state in a single operation.
The clip device of claim 21, further comprising a locking ring that can slidably move over the one or more latch elements to lock the clip.
The clip device of claim 22,
　　wherein the first arm or second arm or both include a projection that prevents the arms from fully retracting in a tube disposed at a distal end of the sheath.
The clip device of claim 22,
　　wherein the locking ring and the one or more latch elements have complementary mating portions which lock the locking ring to the one or more latch elements and to lock the clip.
The clip device of claim 22, further comprising a control member reciprocally movable within the sheath by operation of a control knob that is configured to slidably move the locking ring over the one or more latch elements to lock the clip.
The clip device of claim 25,
　　wherein the control member is an inner sheath and the wire is configured to reciprocally move within the inner sheath to close and open the clip.
The clip device of claim 22, further comprising a tube disposed at a distal end of the sheath,
　　wherein the wire connected to the proximal end of the clip is configured to reciprocally move the clip within the tube to close and open the clip and
　　wherein the locking ring is configured to slidably move over the one or more latch elements and be disposed between the tube and the one or more latch elements in an axial direction to lock the clip.
The clip device of claim 21,
　　wherein the first arm includes a first latch element and the second arm includes a second latch element opposite the first latch element and configured to engage the first latch element to lock the clip.
The clip device of claim 28, further comprising an inner sheath reciprocally movable within the sheath by operation of a control knob that can slidably move over the first arm and second arm to engage the first and second latch elements to lock the clip.
The clip device of claim 28, further comprising a tube connected to a distal end of the sheath, which does not disconnect from the sheath.
The clip device of claim 21, further comprising a stopper connected to a distal end region of the wire and an inner sheath reciprocally movable within the sheath by operation of a control knob,
　　wherein the stopper is configured to abut a distal end of the inner sheath when the clip is in a closed state which prevents the wire from locking the clip and the inner sheath is configured to move proximally to allow operating the wire to move proximally to lock the clip.
The clip device of claim 21, further comprising a stopper configured to stop the wire from moving proximally.
The clip device of claim 31, further comprising a handle having a main body and a slit with a slider located in the slit, wherein the slider is connected to a proximal end of the wire and the stopper is located in the slit to prevent the slider from moving to a proximal end of the slit.
The clip device of claim 32, wherein the stopper is connected to the wire.
The clip device of claim 32, wherein the stopper are protrusions that face each other on the first arm and second arm and the device further includes a tube with a pin in which the pin abuts the stoppers when the clip is retracted proximally in the tube.
A method of operating a clip device, the method comprising
　　closing a clip having a first arm and second arm biased in an open state and having one or more latch elements by pulling a wire connected to a proximal end of the clip to retract the clip in a tube; and
　　locking the clip in a closed state by moving a stopper or by an operation other than pulling the wire to close the clip.
The method of claim 36, further comprising locking the clip by sliding a locking ring distally over the one or more latch elements.
The method of claim36, further comprising locking the clip by sliding an inner sheath over the clip to lock mating latch elements.
A clip device comprising:
　　a clip having a first arm and second arm in which the first arm and second arm are configured to move in a direction toward and away from each other to close and open the clip;
　　a wire connected to a proximal end of the clip configured to reciprocally move within a sheath to close and open the clip; and
　　one or more latch elements on the clip configured to lock the clip in a closed state;
　　wherein a first operation of the clip device reciprocally moves the wire within the sheath to close and open the clip,
　　wherein a second operation of the clip device locks the clip in a closed state, and
　　wherein the first operation is distinct from the second operation.
The clip device of claim 38, wherein the second operation occurs without operating the wire.