JP6931657B2 - Surgical fastening device - Google Patents

Description

The present application claims the benefit of priority to US Provisional Application No. 62 / 312,597 filed on March 24, 2016, the contents of which US Provisional Application is hereby incorporated by reference in its entirety. Incorporated in the book.

Surgical fastening devices, surgical fasteners, and surgical methods of mesh fastening to tissues.

Prolapse is a medical condition in which an organ such as the uterus falls or escapes from its home position. For example, pelvic organ prolapse involves loosening of the connecting tissue that holds the uterus, allowing the uterus to descend into the vagina. It is estimated that half of all women over the age of 50 may experience symptomatic prolapse. The health care effects of prolapse can be diminished based on the aging population. Surgical repair of prolapse is one of the most common procedures performed on women over the age of 70.

In laparoscopic sacral vaginal fusion, a preformed piece of mesh is inserted into the abdomen and attached to the vaginal tissue at one end and to the back of the sacral promenade at the other end, thereby. A surgical technique to lift the vagina, prevent prolapse, and repair pelvic organ prolapse. Adhesion of the mesh to the vaginal wall by suturing is difficult because it requires the insertion of sutures at a particular depth within the vaginal wall. Sutures must provide a secure attachment, but should not pass through the vaginal wall as they can cause serious complications.

The present invention provides devices and methods for delivering surgical fasteners to a controlled and specific depth within tissue and locking closed fasteners to provide reliable and reliable adhesion. offer. The device can be used to anchor the mesh to tissue and therefore in a sacral vaginal fusion procedure for treating prolapse conditions such as pelvic organ prolapse. The surgical fastening device will automatically apply the individual fasteners through the mesh and into the vaginal wall. The suture is inserted into a fixed depth, minimizing the risk of puncturing through the vaginal wall and providing reliable adhesion. Since the device locks the individual fasteners into a closed loop, there is no need to tie a knot, and therefore the devices and methods of the present disclosure are required to perform such procedures. , Save time and skill. The procedure will be cheaper and therefore more widely available, as the procedure can be performed more easily and quickly than by other methods. The device of the present invention will allow a larger number of people to be treated and relieve the pain from a prolapse state.

The surgical fastening devices and fasteners described herein provide benefits and benefits for surgical procedures such as laparoscopic sacral vaginal fusion for pelvic organ prolapse (POP). For example, fasteners are not limited to within a 5 mm diameter width of the laparoscopic instrument, as fasteners can be wider than the shaft diameter. They can be wide (eg, wider than the penetration depth), even for fasteners that will only penetrate to shallow depths. Sufficient width contributes to ensuring that the mesh adheres to the tissue.

In addition, the device has a tip angled with respect to the tissue or the shaft of the device. This means that the device shaft does not have to be oriented linearly towards the surface of the target tissue and the fasteners can be deployed slightly towards the sides of the tip of the shaft. This can prove useful in many procedures.

The device can be used to apply fasteners into very small depths, which is important for some applications. The penetration depth can be very shallow because the device contains a driving member that extends sharply from the tissue facing surface and curves back to the tissue facing surface. The acute angle can preferably be 5 ° to 60 °. The closed loop of the fastener is wide and therefore can cross the strong tissue in the width direction. In effect, the width can be wider than the diameter of the shaft of the device. A very shallow penetration depth is important in applications such as laparoscopic sacral vaginal fusion, where the fastener must provide a secure attachment without passing through the vaginal wall.

In addition, the fasteners disclosed herein do not have sharp edges oriented into the tissue. Such sharp edges can otherwise stimulate nerves and tissues. The disclosed fasteners, when closed, contain all tips or barbs within the smooth pot-like portion of the material, providing only a smooth surface to the surrounding tissue.

The surgical fastening device includes a driving member that extends sharply from the tissue facing surface and curves back to the tissue facing surface. The drive member is made from a superelastic material such as nitinol. Such a material is shallow, wide and unrelated, which gives the drive member the required strength and shape, which is useful and beneficial for procedures such as laparoscopic sacral vaginal fusion. In some configurations, it is advantageous because it allows the fasteners to be fastened.

In one aspect, the invention provides a surgical fastening device. The device comprises a body, a shaft extending from the body, a delivery tip at the distal end of the shaft, and a drive member located within the shaft, with a handle with a trigger extending from it. Includes fasteners held at the delivery tip. The fastener has an extended body with a barbed end and a receiving end. The action of the trigger is to push the barbed end of the fastener onto the drive member outward from the tissue facing surface of the delivery tip, along a curved path back to the tissue facing surface, and into the receiving end. The fastener is thereby formed into a closed fastener, released from the closed fastener, retracted into the shaft, and engaged with a second fastener. Preferably, only a single drive member extends from the delivery tip and fastens the fastener. The delivery tip may result in a tissue facing surface that projects from the shaft and has an exit port on it. The fastener is held at the delivery tip, at least in part, in a guide slot that spatially communicates with the exit port. Preferably, the delivery tip is urged away from the shaft so that the shaft axis and the tissue facing surface form an acute angle.
The drive member comprises a shape memory material that urges the drive member into a curved shape. When the drive member is placed within the shaft, the drive member is constrained by the shaft in a linear shape. In some embodiments, the barbed end of the fastener is placed in a delivery slot that engages with one or more barbs and the distal tip of the drive member, eg, terminates at an exit port. Including pushable surfaces. The receiving end of the fastener may define a pot-shaped portion with an opening and an edge overhanging the opening. The receiving end may be located within the distal end of the guide slot within the delivery tip for delivery. In certain embodiments, the exit port comprises the distal end of the delivery slot and has spatial communication with the distal end of the guide slot.

The action of the trigger is to the drive member with the barbed end of the fastener from the distal end of the delivery slot to the outside, along a curved path to the distal end of the guide slot, and one or more. The barb is pushed into the receiving end of the fastener so that it engages with the edge of the pot-shaped portion of the receiving end, thereby forming the fastener into a closed fastener. Preferably, the step of placing the tissue facing surface against the tissue and pulling the trigger is such that the drive member has a closed fastener across the surface of the tissue over a width W and a depth H within the tissue. The barbed end is pushed through the tissue and into the receiving end of the fastener outside the tissue so as to penetrate. The shaft may have a length L of at least 15 cm and a diameter D of less than 1 cm. In certain embodiments, L ≧ 25 cm, D ≦ 7 mm, and H <D <W.

The delivery tip may be flexible towards the axis of the shaft.

The device includes additional fasteners that are placed with a shaft, each of which triggers can deliver a single fastener and advance the additional fasteners towards the delivery tip.

Aspects of the invention provide surgical fasteners that include an extended body, at least a portion of the extended body being flexibly deformable, with the extended body being a barbed end and Terminated at the receiving end, the receiving end defines a pot-shaped portion with an opening and an edge overhanging the opening. The step of bending the deformable portion of the extended body and inserting the barbed end into the receiving end locks the fastener into a closed loop. Preferably, the barbed end comprises a pointed tip for puncturing through the tissue. When the fastener is locked in the closed loop, the tip of the tip is confined in the pot shape. The closed loop is confined within the pot-shaped portion, at the barbed end and at the first portion of the extended body and at the end of the first portion, which extends substantially linearly from the pot-shaped portion. It may include a bent portion of the extended body and an arched portion of the extended body that defines the curvature between the barbed end and the bent portion. In one embodiment, the closed loop spans a width W from the barbed end confined within the pot to the bent portion, and the bow portion does not exceed the depth H and is separated from the first portion. NS. Preferably, 3 cm> W> H, H <6 mm, or both.

In some embodiments, the barbed end comprises one or more barbs, and when the fastener is locked within the closed loop, the barbs overhang into the opening of the pot. It is retained by the margin. When the fastener is locked in the closed loop, the barb is confined in the pot shape. The barbed end may include a pushable surface behind the tip of the tip.

In some aspects, the invention provides a surgical fastener that includes an extended body, at least a portion of the extended body is flexibly deformable, and the extended body is: Terminate at the rounded ends and the receiving ends that define the loop. The rounded end comprises a bulb shape that requires the rounded end to elastically deform the loop so that it passes through the loop. The step of bending the deformable portion of the extended body and inserting the rounded end into the receiving end locks the fastener into a closed loop. In one embodiment, the closed loop spans a width W from the barbed end confined within the pot to the bent portion, and the bow portion does not exceed the depth H and is separated from the first portion. NS. Preferably, 3 cm> W> H, H <6 mm, or both.

In a related aspect, the present invention is a body and a delivery tip on the handle, a trigger and a shaft extending from the body, and a distal end of the shaft, with a handle extending from it. The delivery tip projects from the shaft, resulting in a tissue facing surface with an exit port on it, and the delivery tip is urged and separated from the shaft so that the shaft axis and tissue facing surface form a sharp angle. The delivery tip is bendable towards the axis of the shaft, the exit port includes the distal end of the delivery slot, which carries the barbed end of the fastener located within the shaft, and the exit port is the fastener. A drive member located within a shaft with a delivery tip that spatially communicates with the distal portion of the guide channel, including the receiving end of the drive member, which is a shape memory that urges the drive member into a curved shape. When the material is provided and the drive member is placed in the shaft, the drive member is held by the drive member, a barbed end held by the delivery slot, and a guide slot, which is constrained in a linear shape by the shaft. At least one fastener having an extended body with a receiving end that engages the distal end of one or more barbs and pushers. It comprises a pushable surface, the receiving end includes a fastener that defines a pot-shaped portion, with an opening and an edge overhanging the opening, and the action of the trigger is on the drive member. The barbed end of the fastener, from the distal end of the delivery slot to the outside, along a curved path to the distal end of the guide slot, and one or more barbs are potted portions of the receiving end. Push into the receiving end of the fastener to engage with the margin of the fastener, thereby forming the fastener into a closed fastener and the closed fastener from the release port. Provided is a surgical fastening device that is released outward, retracted into the shaft, and engaged with a second fastener.

In some aspects, the invention provides a surgical method of attaching a mesh. The method comprises a body, a shaft extending from the body, a delivery tip at the distal end of the shaft, and a drive member located within the shaft, with a handle with a trigger extending from it. Includes the step of obtaining a surgical fastening device, including a fastener that is held at the delivery tip. The fastener has an extended body with a barbed end and a receiving end.

The method pushes the barbed end of the fastener onto the drive member outward from the delivery tip, along a curved path and into the receiving end, thereby closing the fastener. It comprises the step of operating the trigger to form on the fastener, release it from the closed fastener, retract it into the shaft and engage it with the second fastener. Preferably, the delivery tip projects from the shaft, providing a tissue facing surface with an exit port on it. Fasteners are held at the delivery tip, at least in part, in a delivery slot that terminates at the exit port. Preferably, the distal end of the fastener is held within the distal end of the guide slot, which extends through the shaft. In a preferred embodiment of the method, the delivery tip is urged away from the shaft so that the shaft axis and the tissue facing surface form an acute angle, and the drive member urges the drive member into a curved shape. It is provided with a shape memory material to be used.

The method includes the step of constraining the drive member in a linear shape by arranging the drive member in the shaft.

Preferably, the barbed end of the fastener comprises one or more barbs and a pushable surface that is engaged with the distal tip of the push member, and the receiving end of the fastener is open. A pot-shaped portion is defined with a portion and an edge overhanging the opening. The barbed end can be held by the delivery slot and the receiving end can be held by a guide slot (eg, the distal end of the delivery and guide slot).

The method provides the drive member with a barb end of the fastener from the distal end of the delivery slot to the outside, along a curved path to the distal end of the guide slot, and one or more barbs. Triggers to push into the receiving end of the fastener so that it engages with the edge of the pot-shaped portion of the receiving end, thereby forming the fastener into a closed fastener. May include steps to operate.

Preferably, the method also includes a step of placing a tissue facing surface against the tissue and pulling a trigger so that a closed fastener traverses the surface of the tissue, spans a width W, and is within the tissue. The drive member is forced to push the barbed end through the mesh and tissue and into the receiving end of the fastener outside the tissue so as to penetrate at depth H. The shaft may have a length L of at least 15 cm and a diameter D of less than 1.55 cm. In a preferred embodiment of the method, L ≧ 25 cm and D ≦ 10 mm. Further, H <D <W.

The method may include bending the delivery tip towards the axis of the shaft (eg, for insertion through standard trocars or incisions during minimally invasive surgery). The method delivers one or more additional fasteners from the shaft by operating a trigger to deliver a single fastener and advance any residual fastener towards the delivery tip. May include steps to do.
The present specification also provides, for example, the following items.
(Item 1)
Surgical fastening device
A body with a handle and a trigger extending from it,
The shaft extending from the main body and
With the delivery tip at the distal end of the shaft,
The drive member arranged in the shaft and
A fastener held at the delivery tip, wherein the fastener has an extended body with a barbed end and a receiving end.
The operation of the trigger is performed on the driving member.
The barbed end of the fastener is pushed outward from the delivery tip along a path back towards the delivery tip and into the receiving end, thereby closing the fastener. Forming on the fasteners that have been made
To release from the closed fastener
Retreating into the shaft and engaging the second fastener
Let the device do.
(Item 2)
The device of item 1, wherein the delivery tip projects from the shaft and provides a tissue facing surface with an exit port on it.
(Item 3)
The device of item 2, wherein the fastener is held in the guide slot, at least in part, at the delivery tip.
(Item 4)
The device of item 3, wherein the delivery tip is urged and separated from the shaft so that the shaft and the tissue facing surface form an acute angle.
(Item 5)
The device according to item 4, wherein the drive member comprises a shape memory material that urges the drive member into a curved shape.
(Item 6)
The device according to item 5, wherein when the drive member is arranged in the shaft, the drive push member is constrained in a linear shape by the shaft.
(Item 7)
6. The device of item 6, wherein the barb end of the fastener comprises one or more barbs and a pushable surface that engages with the distal tip of the drive member.
(Item 8)
7. The device of item 7, wherein the receiving end of the fastener defines a pot-shaped portion with an opening and an edge overhanging the opening.
(Item 9)
8. The device of item 8, wherein the exit port comprises a distal end of a delivery slot extending through the shaft, the exit port spatially communicating with a distal portion of a guide slot extending through the shaft.
(Item 10)
The action of the trigger is such that the drive member has the barbed end of the fastener from the distal end of the delivery slot to the outside, along a curved path to the distal end of the guide slot, and said. One or more barbs were pushed into the receiving end of the fastener so that it was engaged with the edge of the potted portion of the receiving end, thereby closing the fastener. Item 9. The device according to item 9, which is formed on a fastener.
(Item 11)
In the step of installing the tissue facing surface on the tissue and pulling the trigger, the closing fastener is attached to the driving member across the surface of the tissue over a width W and within the tissue. 10. The device of item 10, wherein the barbed end is pushed through the tissue and into the receiving end of a fastener outside the tissue so as to penetrate at depth H.
(Item 12)
The device of item 11, wherein the shaft has a length L of at least 15 cm and a diameter D of less than 1.55 cm.
(Item 13)
The device of item 12, wherein L ≧ 25 cm and D ≦ 10 mm.
(Item 14)
The device according to item 13, wherein H <D <W.
(Item 15)
14. The device of item 14, wherein the delivery tip is bendable towards the axis of the shaft.
(Item 16)
Further comprising a plurality of additional fasteners arranged with the shaft, each of the trigger actions delivers a single fastener and advances the additional fastener towards the delivery tip. , Item 15.
(Item 17)
16. The device of item 16, wherein the fastener is formed on the closed fastener only through the drive member, without any other member extending from the delivery tip.
(Item 18)
Surgical fasteners, said fasteners
An extended body, at least a portion of the extended body being flexibly deformable, the extended body being terminated at a barbed end and a receiving end, the receiving end being An extended body that defines a pot-shaped portion, with an opening and an edge overhanging the opening.
A fastener.
(Item 19)
18. The step of bending the deformable portion of the extended body and inserting the barbed end into the receiving end locks the fastener into a closed loop, item 18. Fastener.
(Item 20)
The barbed end comprises a cusp tip for puncturing through tissue, and when the fastener is locked in the closed loop, the cusp tip is confined within the pot-shaped portion. The fastener according to item 19.
(Item 21)
The closed loop includes a barbed end confined within the pot-shaped portion, a first portion of the extended body extending substantially linearly from the pot-shaped portion, and an end of the first portion. The item 20 comprises a bent portion of the extended body in the portion and an arched portion of the extended body that defines a curvature between the barbed end and the bent portion. Fasteners.
(Item 22)
The closed fastener extends from the barbed end confined in the pot-shaped portion to the bent portion over a width W, and the bow-shaped portion does not exceed the depth H and is from the first portion. The fastener according to item 21, which is separated.
(Item 23)
The fastener according to item 22, wherein 3 cm>W> H.
(Item 24)
The fastener according to item 23, wherein H <6 mm.
(Item 25)
The barbed end comprises one or more barbs, and when the fastener is locked in the closed loop, the barb overhangs the opening of the pot-shaped portion. 24. The fastener according to item 24, which is retained by.
(Item 26)
25. The fastener according to item 25, wherein when the fastener is locked in the closed loop, the barb is confined in the pot-shaped portion.
(Item 27)
26. The fastener according to item 26, wherein the barbed end comprises a pushable surface behind the tip of the tip.
(Item 28)
Surgical fastening device
The main body with the handle extending from there,
With the trigger on the handle,
The shaft extending from the main body and
A delivery tip at the distal end of the shaft, the delivery tip protruding from the shaft and providing a tissue facing surface with an exit port on which the delivery tip is the axis of the shaft and the tissue facing surface. Is urged away from the shaft to form a sharp angle, the delivery tip is bendable towards the axis of the shaft, and the outlet port at the distal end of the delivery slot extends through the shaft. There is a delivery tip,
A drive member arranged in the shaft, the drive member includes a shape memory material that urges the drive member into a curved shape, and when the drive member is arranged in the shaft, The drive pushing member is a drive member that is constrained in a linear shape by the shaft.
At the delivery tip, at least one fastener that is held at least partially in a guide slot that spatially communicates with the exit port, the fastener being extended with a barbed end and a receiving end. It has a body, the barbed end comprises one or more barbs and a pushable surface that engages with the distal tip of the pushing member, the receiving end with an opening. With at least one fastener defining a pot-shaped portion, with a margin overhanging the opening.
The operation of the trigger is performed on the driving member.
The barb end of the fastener is outward from the distal end of the delivery slot, along a curved path to the distal end of the guide slot, and one or more barbs are receiving ends. Pushing into the receiving end of the fastener so that it engages with the margin of the pot-shaped portion of the fastener, thereby forming the fastener into a closed fastener.
To release the closed fastener to the outside through the release port,
Retreating into the shaft and engaging the second fastener
Let the device do.

FIG. 1 shows a surgical fastening device. FIG. 2 shows the delivery tip of the device. FIG. 3 shows the surgical fastener of the present invention. FIG. 4 shows a fastener formed in a closed loop. FIG. 5 shows a fastener held within the delivery tip. FIG. 6 presents a detailed view of the barbed end of the fastener and the drive member. FIG. 7 shows a driving member extending along a curved path. FIG. 8 shows a drive member released from a closed fastener. FIG. 9 shows a closed fastener released from the guide slot. FIG. 10 shows a fastener formed in a closed loop. FIG. 11 shows the steps of positioning the device relative to the surface of the tissue. FIG. 12 shows a driving member extending through the tissue. FIG. 13 shows a closed loop that holds the mesh in the tissue. FIG. 14 shows a device loaded with a plurality of fasteners. FIG. 15 is an outline of the delivery tip. FIG. 16 shows a bent delivery tip. FIG. 17 shows a slit that can be included on the delivery tip. FIG. 18 illustrates pelvic organ prolapse. FIG. 19 illustrates a sacral vaginal fusion procedure.

Devices and methods for delivering surgical fasteners to a specific depth within the tissue and locking the fasteners for anchoring the mesh to the tissue are for treating prolapse conditions such as pelvic organ prolapse. Useful for sacral vaginal fusion procedures. The devices of the present invention generally have a body with a handle and an extended shaft, sized for minimally invasive surgery. That is, the shaft is preferably smaller in diameter than a standard trocar (eg, it can be <about 15.5 mm in diameter, preferably <10 mm). The shaft is preferably long enough to reach the surgical target, eg, at least about 15 cm long, preferably at least 25 cm long. The shaft terminates within the delivery tip that provides a tissue facing surface at an acute angle to the axis of the shaft. Due to this arrangement, when the drive member extends from the shaft while the tissue facing surface is held against the surface of the target tissue, the drive member first punctures the tissue at an acute angle. (Eg, about 25 ° to 65 °), this allows the fastener to limit the penetration depth, minimize the risk of puncturing through tissue (eg, vaginal wall), and provide reliable adhesion. Allows for a wide range. The fasteners can be wider than the diameter of the shaft of the device, and the fasteners are not limited to within the width of the diameter of the laparoscopic instrument. They can be wide (eg, wider than the penetration depth), even for fasteners that will only penetrate to shallow depths. The closed loop of the fastener is wide and therefore can cross the strong tissue in the width direction. In effect, the width can be wider than the diameter of the shaft of the device. Fasteners preferably have sharp edges that, once fastened, will capture any tip or barb within a smooth bowl and thus otherwise stimulate nerves and tissues. No. The drive member is made from a superelastic material such as nitinol. Such a material is shallow, wide and unrelated, which gives the drive member the required strength and shape, which is useful and beneficial for procedures such as laparoscopic sacral vaginal fusion. In some configurations, it is advantageous because it allows the fasteners to be fastened.

FIG. 1 shows a surgical fastening device 101. The device 101 includes a body 109 with a handle 113 with a trigger 117 extending from it, a shaft 103 extending from the body 109, and a delivery tip 201 at the distal end of the shaft. The trigger 117 is operably engaged with a drive member extending through the shaft 103. Any suitable engagement can be used. For example, the trigger can result in a curved, geared surface within the body 109. A curved, geared surface can be engaged with a geared slot wheel (optional and optional, increasing or decreasing the magnitude of rotation applied as the trigger 117 is squeezed and rotated around the Axis. Through the stepper gears). The geared slot wheel in the handle 109 may include an eccentric slot and the proximal end of the drive member may have a pin engaged in the slot. Trigger squeezing rotates the slot wheel. The eccentric slot pushes the pin in a direction that includes a displacement parallel to the axis of the shaft 103. The displacement of the pin pushes the drive member distally along the shaft 103 and then pulls the drive member back proximally. Therefore, squeezing the trigger 117 translates the drive member outward and back along the shaft to deliver the fastener, as described below. Suitable geared triggers with slot wheels and pins that can be modified for use with the present invention are incorporated by reference in US Pat. No. 8,535,339 (see, eg, FIG. 14 and accompanying text). Shown in.

FIG. 2 shows the delivery tip 201. The delivery tip 201 includes an extension 205 that results in a tissue facing surface 207 with an outlet port 221 projecting from the shaft 103 and spatially communicating with the guide slot 215. The exit port 221 is proximal to the axis of the shaft and includes the distal end of delivery slot 225. The guide slot 215 extends from the shaft 103, curves through the extension 205, and terminates at the release port 209. The delivery slot 225 opens into the outlet port 221 which allows the drive member to be pushed outward from the shaft and through the exit port 221. The delivery tip 201 is urged and separated from the shaft 103 so that the shaft axis and the tissue facing surface 207 form an acute angle. The guide slot 215 holds the end of the fastener 301 therein.

FIG. 3 shows the surgical fastener 301. The fastener 301 includes an extended main body 321, and at least a part 319 of the extended main body 321 can be flexibly deformed. The extended body 321 terminates at the barbed end 305 and the receiving end 339. Preferably, the receiving end 339 defines a pot-shaped portion 327 with an opening and an edge 333 overhanging the opening.

The barbed end 305 may include a cusp tip 341 for puncturing through the tissue.

The step of bending the deformable portion 319 of the extended body and inserting the barbed end 305 into the receiving end 339 locks the fastener 301 into the closed loop 401.

The barbed end 305 of the fastener 301 has one or more barbs 311. In a preferred embodiment, the barbed end 305 comprises one or more pushable surfaces 317 posterior to the cusp tip 341.

FIG. 4 shows a fastener 301 formed in a closed loop 401. When the fastener 301 is locked within the closed loop 401, the pointed tip 341 is confined within the pot-shaped portion. Preferably, the closed loop 401 is confined within the pot-shaped portion 327 with a barbed end 305 and a first portion 415 of the extended body 321 extending substantially linearly from the pot-shaped portion 327. , The extended body 321 at the end of the first portion 415, defining the curvature between the bent portion 411 of the extended body 321 and the barbed end 305 and the bent portion 411. Includes the bow-shaped portion 407 of. When the fastener 301 is locked in the closed loop 401, the barb is confined in the pot-shaped portion 327.

Specifically, when the fastener 301 is locked in the closed loop 401, the barb 311 is held by an edge 333 overhanging the opening of the pot-shaped portion 327.

FIG. 5 shows the fastener 301 held within the delivery tip 201. The drive member 601 is arranged in the shaft 103, in which the drive member 601 is pulled in and guided by a delivery slot 225 extending in the shaft 103. It can be understood that the receiving end 339 of the fastener 301 is held in the guide slot 225. The barbed end 305 of the fastener 301 is held by the delivery slot 225. The pushable surface 317 of the barbed end 305 is oriented to engage the distal tip 611 of the drive member 601. The exit port 221 defines a space through which the drive member 601 can push the barbed end 305 of the fastener 301 to the outside of the shaft 103.

As shown in FIG. 5, the guide slot 215 holds the receiving end 339 of the fastener 301 and the delivery slot 225 holds the barbed end 305 of the fastener 301. The receiving end 339 is held in place during the operation of the device 101 to prevent it from retracting to the shaft 103 due to tension in the fastener. The guide slot 215 opens at the release port 209 on the distal end of the guide slot 215 to facilitate the release of the closed fastener 401 from the device once the fastener has been delivered and locked. .. Preferably, the guide slot 215 is characterized by having a narrow width along the tissue facing surface 207 to hold the receiving end 339 during its advance along the slot 215. In some embodiments, device 101 includes a spring-loaded mechanism within the operating handle to facilitate faster application, which may be necessary for better penetration through tissue. ..

FIG. 6 presents a detailed view of the barbed end 305 of the fastener 301 and the distal tip 611 of the drive member 601. The pushable surface 317 includes a recess defined to receive the distal tip 611. The drive member 601 also includes a thinner extension 607 and may be fully engaged with the pushable surface 317 on the barbed end 305 of the fastener 301. The barbed end 305 of the fastener 301 has a barb and a pushable surface 317 that engages with the distal tip 611 of the drive member 601 (in FIG. 6, the pushable surface 317 and the distal tip). The 611 is separated and aids visualization, but it will be readily understood that the distal tip 611 engages the pushable surface 317). FIG. 6-10 illustrates the movement of the surgical fastening device 101 in response to the movement of the trigger 117.

The step of pulling the trigger 117 pushes the barbed end 305 of the fastener onto the drive member 601 outward from the delivery slot 225 on the delivery tip 201, along a curved path and into the receiving end 339. It is moved, thereby forming the fastener into the closed fastener 401, releasing it from the closed fastener 401, retracting it into the shaft 103, and engaging it with the second fastener.

FIG. 7 shows a drive member 601 that extends along a curved path and pushes the barbed end 305 of the fastener 301 into the receiving end 339. It will be understood that the drive member 601 includes a shape memory material that urges the drive member 601 into a curved shape, as illustrated in FIG. When the drive member 601 is arranged in the shaft 103, the drive member 601 is constrained in a linear shape by the delivery slot 225 in the shaft 103.

FIG. 8 shows the drive member 601 released from the closed fastener 401. Specifically, the operation of the trigger 117 is to attach the barbed end 305 of the fastener 301 to the drive member 601 outward from the exit port 221 of the delivery tip 201, along a curved path, and one or more thereof. The return 311 above is pushed into the receiving end 339 held in the guide slot 215 so that it engages with the edge 333 of the pot-shaped portion 327 of the receiving end 339, thereby the fastener. The 301 is formed on the closed fastener 401.

FIG. 9 shows a closed fastener 401 released through release port 209 as the drive member 601 retracts into the shaft 103 and engages the second fastener.

One important feature of the surgical fastening device 101 is the control of delivery depth and fastening strength provided by the particular dimensional relationship between the fastener 301 and the device 101. The step of installing the tissue facing surface 207 against the tissue and pulling the trigger 117 causes the drive member 601 to push the barbed end back through the tissue and into the receiving end 339 of the fastener on the outside of the tissue and fasten. The tool 301 is formed in a closed loop 401.

FIG. 10 shows a fastener 301 formed in a closed loop 401 with the delivery tip 201 still in place with respect to tissue 505. Here, device 101 is used to fasten mesh 511 to tissue 505. The shaft 103 is positioned such that the tissue facing surface 207 of the delivery tip 201 faces the surfaces of the mesh 511 and the tissue 505. The closed fastener 401 traverses the surface of the tissue, spans a width W, and penetrates a depth H within the tissue. The delivery tip 201 is urged away from the shaft 103 so that the axis of the shaft 103 and the tissue facing surface 207 form an acute angle A, so that the shaft 103 forms an angle A with the surface of the tissue 505. In a preferred embodiment, the shaft is sized for minimally invasive surgery and has a length L of at least 15 cm and a diameter D of less than 1 cm. More preferably, L ≧ 25 cm and D ≦ 7 mm. Most preferably, H <D <W.

FIG. 11-13 shows the operation of the device 101.

FIG. 11 shows a step of positioning the tissue facing surface 207 with respect to the surface of the tissue 505, specifically with respect to the mesh 511 fastened to the tissue.

FIG. 12 shows a drive member 601 extending through tissue 505 and forming fasteners 301 in a closed loop 401.

FIG. 13 shows a closed loop 401 holding mesh 511 in tissue 505. The closed loop 401 is confined in the pot-shaped portion 327, with a barbed end 305, a first portion 415 of the extended body 321 extending substantially linearly from the pot-shaped portion 327, and a first. Extended, defining the curvature extending through the tissue 505 between the bent portion 407 of the extended body 321 and the barbed end 305 and the bent portion 411 at the end of the portion 415. Includes the bow-shaped portion 407 of the main body 321. For successful surgical procedures, the closed fastener 401 preferably spans a width W from the barbed end 305 confined within the pot-shaped portion 327 to the bent portion 411, with the bow-shaped portion 407. Preferably, it does not exceed the depth H and is separated from the first portion 415. In a preferred embodiment, 3 cm> W> H. In addition, or as an alternative, it may be preferable that H <6 mm.

As discussed above, the step of pulling the trigger 117 causes the device 101 to form the fastener on the closed fastener 401, release it from the closed fastener 401, and retract it into the shaft 103. And engage with the second fastener.

FIG. 14 shows a device 101 loaded with a fastener 301, a second fastener 399, and three additional fasteners 1401 arranged within a shaft. The delivery slot 225 extending to the exit port 221 and the guide slot 215 extending to the release port 209 are also visible within the shaft 103. Each of the fasteners 301 is held in the shaft 103 in an open configuration, the receiving end is held in the guide slot 215, and the barbed end 205 is held in the delivery slot 225. The device 101 may be loaded with any suitable number of fasteners 301. Each of the trigger actions delivers a single fastener and advances the additional fastener towards the delivery tip.

For minimally invasive surgery, the delivery tip 201 is flexible towards the axis of the shaft 103, i.e. the extended shaft is most easily able to pass through a standard surgical trocar. That can be preferable.

FIG. 15 is an outline of the delivery tip 201. It can be understood that the delivery tip 201 is urged and separated from the shaft 103 so that the axis X of the shaft 103 and the tissue facing surface 207 form an acute angle. For example, it may be possible to deform the delivery tip 201 to facilitate insertion of the shaft 103 through a standard surgical trocar.

FIG. 16 shows a delivery tip 201 bent towards axis X.

FIG. 17 shows a compression slit 1701 and an expansion slit 1709 that may be included so that the delivery tip 201 can be more easily bent towards the shaft 103 axis X. It will be appreciated that the axis X is an idealized geometric concept defined by the substantially cylindrical nature of the shaft 103 and does not need to have any tangible shaft axis. Axis X is referenced to help understand the configuration of delivery tip 201.

Accordingly, the present disclosure discloses a body 109 with a handle 113 extending from it, a trigger 117 on the handle, a shaft 013 extending from the body, and a delivery tip 201 at the distal end of the shaft 103. The delivery tip 201 projects from the shaft 103 to provide a tissue facing surface 207 with an exit port 221 and a guide slot 215, which is such that the axis of the shaft 103 and the tissue facing surface 207 have a sharp angle. Bounced away from the shaft 103 to form, the delivery tip 201 is bendable towards the axis of the shaft 103, and the outlet port 221 includes the delivery tip and the shaft, including the end of the delivery slot 225. A drive member 601 arranged within the 103, wherein the drive member 601 includes a shape memory material that urges the drive member 601 into a curved shape, and the drive member 601 is arranged within the shaft 103. When the drive push member 601 is linearly constrained by the shaft 103, at least one fastener 301 is held in the guide slot 215 at least partially in the drive member and the delivery tip 201. The fastener has an extended body 321 with a barb end 305 and a barb end 339, the barb end 305 having one or more barbs 311 and a drive member 601. Fastener with a pushable surface 317 engaged with the distal tip 611, the receiving end 339 defining a pot-shaped portion 327 with an opening and a margin 333 overhanging the opening. The operation of the trigger 117 includes, on the drive member 601 the barbed end 305 of the fastener 301 on a curved path outward from the exit port 221 to the receiving end 339 held by the guide slot 215. Along and one or more barbs 311 are pushed into the receiving end 339 of the fastener 301 so as to engage the margin 333 of the pot-shaped portion 327 of the receiving end 339, thereby. , The fastener 301 is formed on the closed fastener 401, the closed fastener is released from the release port 209, retracted into the shaft 103 and engaged with the second fastener 399 for surgery. It can be understood that the fastening device 101 is included.

Other documents such as patents, patent publications, and treatises are also referenced within this disclosure. All such documents are incorporated by reference.

In addition to what is illustrated and described herein, various modifications of the present invention and many further embodiments thereof are made from the entire contents of this document, including references to scientific and patent documents cited herein. Will be apparent to those skilled in the art. The disclosure herein contains information, examples, and guidelines that may be adapted to the practice of the invention in its various embodiments and equivalents thereof.

Laparoscopic sacral vaginal fusion for pelvic organ prolapse (POP).

FIG. 18 illustrates pelvic organ prolapse. Approximately half of all women over the age of 50 complain of symptomatic prolapse, as reported in Swift's Am J Obtest Gynecol 183 (2): 277-85 (incorporated by reference) in 2000. ..

The health care implications of prolapse may be exacerbated based on estimates of increasing morbidity in the population growth of older women. 2009 Wu et al. Forecasting the prevalence of pelvic floor disorders in U.S.A. S. See Woman: 2010 to 2050, Obstet Gynecol 114: 1278 (incorporated by reference). Surgical repair of prolapse was the most common hospitalization procedure performed in women over the age of 70 from 1979 to 2006. 2010 Olifant et al. See Trends over time with communly performed obstetric and gynecological inpatient processes, Obstetric Gynecol 116: 926 (incorporated by reference).

Laparoscopic sacral vaginal fusion is a surgical technique for repairing pelvic organ prolapse.

FIG. 19 illustrates a sacral vaginal fusion procedure. During the procedure, a preformed piece of mesh is inserted into the abdomen and attached to the vaginal wall, then the other end of the mesh is attached to the back of the pelvis (sacral promonch) and thus the vagina. Lift and prevent prolapse. Adhesion of the mesh to the vaginal wall by suturing is difficult because it requires the insertion of sutures at a particular depth within the vaginal wall. Sutures must provide a secure attachment, but should not pass through the vaginal wall as they can cause serious complications.

The mesh can be attached using the method of attaching the mesh according to the present disclosure. The method comprises a body, a shaft extending from the body, a delivery tip at the distal end of the shaft, and a drive member located within the shaft, with a handle with a trigger extending from it. Includes the step of obtaining a surgical fastening device, including a fastener that is held at the delivery tip.

The method pushes the barbed end of the fastener onto the drive member outward from the delivery tip, along a curved path and into the receiving end, thereby closing the fastener. It comprises the step of operating the trigger to form on the fastener, release it from the closed fastener, retract it into the shaft and engage it with the second fastener. Preferably, the delivery tip projects from the shaft to provide a tissue facing surface that provides an exit port. The fastener is held in the guide slot, at least in part, at the delivery tip. In a preferred embodiment of the method, the delivery tip is urged away from the shaft so that the shaft axis and the tissue facing surface form an acute angle, and the drive member urges the drive member into a curved shape. It is provided with a shape memory material to be used.

The method includes the step of constraining the drive member in a linear shape by arranging the drive member in the shaft.

Preferably, the barbed end of the fastener comprises one or more barbs and a pushable surface that is engaged with the distal tip of the push member, and the receiving end of the fastener is open. A pot-shaped portion is defined with a portion and an edge overhanging the opening. The exit port may include the end of the delivery slot.

The method provides the drive member with a barb end of the fastener from the distal end of the delivery slot to the outside, along a curved path to the distal end of the guide slot, and one or more barbs. Triggers to push into the receiving end of the fastener so that it engages with the edge of the pot-shaped portion of the receiving end, thereby forming the fastener into a closed fastener. May include steps to operate.

Preferably, the method also includes a step of placing a tissue facing surface against the tissue and pulling a trigger so that a closed fastener traverses the surface of the tissue, spans a width W, and is within the tissue. The drive member is forced to push the barbed end through the tissue and into the receiving end of the fastener outside the tissue so as to penetrate at depth H. The shaft may have a length L of at least 15 cm and a diameter D of less than 1 cm. In a preferred embodiment of the method, L ≧ 25 cm and D ≦ 7 mm. Further, H <D <W.

The method may include bending the delivery tip towards the axis of the shaft (eg, for insertion through standard trocars or incisions during minimally invasive surgery). The method delivers one or more additional fasteners from the shaft by operating a trigger to deliver a single fastener and advance any residual fastener towards the delivery tip. May include steps to do.

Claims (17)

Surgical fastening device
A body with a handle and a trigger extending from it,
The shaft extending from the main body and
With the delivery tip at the distal end of the shaft,
The drive member arranged in the shaft and
A fastener held at the delivery tip, the fastener comprising a fastener having an extended body with a barbed end and a receiving end, the trigger operation of the driving member. NS,
The barbed end of the fastener is pushed outward from the delivery tip along a path back towards the delivery tip and into the receiving end, thereby closing the fastener. Forming on the fasteners that have been made
To release from the closed fastener
A device that retracts into the shaft and engages with a second fastener. The device of claim 1, wherein the delivery tip projects from the shaft and provides a tissue facing surface with an exit port on it. The device of claim 2, wherein the fastener is held in the guide slot, at least in part, at the delivery tip. The device of claim 3, wherein the delivery tip is urged away from the shaft so that the axis of the shaft and the tissue facing surface form an acute angle. The device of claim 4, wherein the drive member comprises a shape memory material that urges the drive member into a curved shape. When said drive member is disposed within said shaft, said drive moving member is by the shaft, it is constrained in a linear shape, The device of claim 5. The device of claim 6, wherein the barbed end of the fastener comprises one or more barbs and a pushable surface that engages with the distal tip of the driving member. The receiving end of the fastener defines an opening, the pot-shaped part with a peripheral projecting into the opening, according to claim 7 device. 8. The device of claim 8, wherein the exit port includes a distal end of a delivery slot that extends through the shaft, and the exit port is spatially communicable with a distal portion of a guide slot that extends through the shaft. .. The action of the trigger is such that the drive member has the barbed end of the fastener from the distal end of the delivery slot to the outside, along a curved path to the distal end of the guide slot, and said. One or more barbs were pushed into the receiving end of the fastener so that they were engaged with the edge of the potted portion of the receiving end, thereby closing the fastener. The device according to claim 9, which is formed on the fastener. In the step of installing the tissue facing surface on the tissue and pulling the trigger, the closing fastener is attached to the driving member across the surface of the tissue over a width W and within the tissue. 10. The device of claim 10, wherein the barbed end is pushed through the tissue and into the receiving end of a fastener outside the tissue so as to penetrate at depth H. 11. The device of claim 11, wherein the shaft has a length L of at least 15 cm and a diameter D of less than 1.55 cm. 12. The device of claim 12, wherein L ≧ 25 cm and D ≦ 10 mm. 13. The device of claim 13, wherein H <D <W. 14. The device of claim 14, wherein the delivery tip is bendable towards the axis of the shaft. Further comprising a plurality of additional fasteners arranged with the shaft, each of the trigger actions delivers a single fastener and advances the additional fastener towards the delivery tip. , The device of claim 15. 16. The device of claim 16, wherein the fastener is formed on the closed fastener only through the drive member, without any other member extending from the delivery tip.

Images