CN118490417A

CN118490417A - Papillary muscle band with smooth closure

Info

Publication number: CN118490417A
Application number: CN202310149287.3A
Authority: CN
Inventors: D·诺伊斯塔德特; B·马那什
Original assignee: Heart Success Ltd
Current assignee: Heart Success Ltd
Priority date: 2023-02-15
Filing date: 2023-02-15
Publication date: 2024-08-16

Abstract

Embodiments of the present disclosure include a cardiac device including a band configured to form a loop within a heart and including a first end and a second end, a plurality of sequential locking segments located in a region of the band proximate the second end, and an actuatable clasp located at or near the first end. Each locking segment may have a raised region and a sloped region. The actuatable clasp may be configured to form a fixed length loop by locking onto the raised area of the locking segment after the second end has been inserted into the clasp. Adjacent locking segments may be configured to bend relative to one another such that adjacent sloped regions can cooperate to facilitate sliding of the locking segments into the buckle.

Description

Papillary muscle band with smooth closure

Cross Reference to Related Applications

The present application continues in part from U.S. non-provisional patent application Ser. No. 16/166291, filed on 22. 10, 2018, which claims priority from U.S. provisional patent application Ser. No. 62/575538, filed on 23, 10, 2017. The disclosures of the above applications are incorporated herein by reference in their entirety.

Technical Field

Some applications of the present invention generally relate to devices and methods for improving cardiac function. More particularly, some applications of the invention relate to cardiac devices for transcatheter repositioning of papillary muscles in the body's heart.

Background

Repositioning papillary muscles within the heart chamber during atrioventricular valve repair procedures may improve results. Papillary muscle displacement due to ischemia, heart failure, or other causes of ventricular remodeling may lead to tethering of the valve leaflets, which may interfere with their normal function. Repair focused only on the valve annulus often results in recurrence of regurgitation due to leaflet tethering.

Methods of papillary muscle repositioning include suturing from the papillary muscle to the valve annulus or aorta, a sling around multiple papillary muscles to draw the papillary muscles together, and suturing to draw the papillary muscles together. However, these methods of papillary muscle repositioning are typically performed during open heart surgery.

Another method of repositioning papillary muscles includes positioning a band around the papillary muscles to improve cardiac function. For example, transcatheter papillary muscle bands are inserted into the heart chambers through a catheter and locked tightly around the base of the papillary muscle to reposition the papillary muscle and improve cardiac function. Some transcatheter papillary muscle bands include a clasp that can be actuated by a catheter to lock the band in the loop forming the sling. The clasp may lock onto any one of a plurality of ridges or protrusions along the strap, allowing the size of the loop to be adjusted prior to locking the clasp.

In some sling designs, the distal end of the sling containing the protuberance may be pulled through the buckle until the desired loop size is obtained. The clasp may then be actuated to lock onto the protuberance of the strap located within the clasp. Because the band is tightly wrapped around the papillary muscle, the distal end of the band may not be inserted into the buckle in a straight configuration during insertion, but may be inserted at an angle. Because of the angle at which the strap is inserted into the buckle (which may typically be up to or greater than 90 degrees), the locking ridge in the distal portion of the strap may interfere with the insertion of the strap into the buckle. For example, the bulge may increase the amount of force required to pull the strap into the buckle and may make the insertion unstable and difficult to control. This interference with the insertion of the buckle due to the protrusion in the strap is referred to as the "protrusion effect". While the change in radius of the strap is a mechanical feature that allows the buckle to lock onto the protuberance, the change in radius is also a mechanical feature that interferes with the smooth insertion of the strap into the buckle.

Accordingly, there is a need for a system and method for papillary muscle repositioning that reduces the bulging effect of the smooth insertion of the interfering strap into the buckle.

Disclosure of Invention

The presently disclosed embodiments recognize that there is a need for improved devices and methods for repositioning papillary muscles that can be more easily positioned, adjusted, and locked in place, while also reducing the effects of bumps, as compared to conventional devices and methods. Furthermore, the presently disclosed embodiments may address the need for a device and method for repositioning papillary muscles that potentially enable papillary muscle repositioning to be performed on a beating heart through a catheter. In addition, conventional devices and methods for papillary muscle repositioning have been commercially scarcely successful. Accordingly, there is a need for improved devices and methods, whether delivered through a catheter or otherwise.

Embodiments of the present disclosure include devices and methods for repositioning papillary muscles. Advantageously, the exemplary embodiments provide a method of repositioning papillary muscles by delivering a tape through a trabecula. The strap may include a plurality of sequential locking segments that are to be inserted into an adjustable buckle to form a loop. Various embodiments of the disclosure may include one or more of the following aspects.

According to an embodiment of the present disclosure, a cardiac device is provided that includes a band configured to form a loop within a heart and including a first end and a second end, and a plurality of sequential locking segments located in a region of the band proximate the second end. Each locking segment may include a raised region and a sloped region. The cardiac device can further include an adjustable clasp at or near the first end. The adjustable clasp may be configured to form a fixed length loop by locking onto the raised area of the locking section after the second end has been inserted into the clasp. Adjacent locking segments may be configured to bend relative to one another such that adjacent sloped regions can cooperate to facilitate sliding of the locking segments into the buckle.

According to embodiments of the present disclosure, at least a portion of the strap may be a tube and the plurality of sequential locking segments may be located within the tube. According to a further embodiment of the present disclosure, each locking segment may be tapered. In some embodiments, adjacent locking segments may be connected together by a mechanical joint configured to allow the locking segments to rotate relative to one another in at least one plane. In yet another embodiment, adjacent locking segments may comprise beads strung on flexible wires. In some embodiments, the locking segments may be separated by spacer beads. In some embodiments, at least a portion of each spacer bead may be located within the hollow interior of the locking segment.

According to another embodiment of the invention, adjacent locking segments may include a hollow interior such that the sloped region of each locking segment may be rotated relative to the centerline of the chain sequential locking segment to reduce the size of the protrusion between adjacent locking segments. In some embodiments, the plurality of sequential locking segments may be integrally formed from a single piece, and the single piece may include an area connecting the plurality of sequential locking segments. These areas may be more flexible than the locking segments.

In yet another embodiment of the present invention, the raised and sloped regions of the plurality of sequential locking segments may slope and bulge in only one plane such that the raised and sloped regions have at least one side that is smooth and free of projections.

According to another embodiment of the invention, the strap may be made of a material configured to allow the adjustable clasp to close on the outside surface of the tube and securely lock onto the raised area of the locking section inside the tube. In some embodiments, the band may comprise at least one of Polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), or dacron.

According to another embodiment of the present disclosure, the plurality of sequential locking segments may include a first end and a second end. The second end of the strap may be connected to the first ends of the plurality of sequential locking segments. In some embodiments, the second ends of the plurality of sequential locking segments may be connected to locations along the belt.

According to another embodiment of the invention, the locking segments may include indentations, and the indentations may be configured such that when the belt is bent, adjacent locking segments are configured to align with each other such that there are no protrusions between adjacent locking segments, thereby providing a smooth surface along the inner surface of the belt.

In another embodiment of the present disclosure, the locking segments and spacer beads may be configured such that when the belt is bent, adjacent locking segments are configured to align with each other such that there are no protrusions between adjacent locking segments, thereby providing a smooth surface along the inner surface of the belt.

In yet another embodiment of the invention, the regions connecting the plurality of sequential locking segments and locking segments may be configured such that when the belt is bent, adjacent locking segments are configured to align with one another such that there are no protrusions between adjacent locking segments, thereby providing a smooth surface along the inner surface of the belt.

Additional objects and advantages of the embodiments will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the embodiments. The objects and advantages of the embodiments will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claims.

Drawings

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, the accompanying drawings of which:

FIG. 1A illustrates an exemplary apparatus for repositioning papillary muscles according to an embodiment of the present disclosure;

FIG. 1B illustrates an exemplary apparatus for repositioning papillary muscles according to another embodiment of the present disclosure;

FIG. 1C shows an enlarged view of the exemplary device of FIG. 1B;

FIG. 2 illustrates an exemplary band for repositioning papillary muscles in a ring according to another embodiment of the present disclosure;

FIG. 3 illustrates an exemplary anatomy of a human heart in which embodiments of the present disclosure may be employed;

FIG. 4 illustrates an exemplary embodiment of an adjustable clasp according to an embodiment of the present disclosure;

FIG. 5 illustrates another exemplary embodiment of an adjustable clasp according to an embodiment of the present invention;

FIG. 6 illustrates another exemplary embodiment of an adjustable clasp according to an embodiment of the present invention;

FIG. 7A illustrates an exemplary embodiment of an adjustable clasp according to an embodiment of the present disclosure;

FIG. 7B illustrates another exemplary embodiment of an adjustable clasp according to an embodiment of the present disclosure;

FIG. 7C illustrates another exemplary embodiment of an adjustable clasp according to an embodiment of the present disclosure;

FIG. 7D illustrates another exemplary embodiment of an adjustable clasp according to an embodiment of the present disclosure;

FIG. 8 illustrates an exemplary human body in which embodiments of the present disclosure may be employed;

FIG. 9 illustrates an exemplary delivery device in which embodiments of the present disclosure may be employed;

FIG. 10 illustrates an exemplary delivery device with an exemplary insert cable according to an embodiment of the present disclosure;

FIG. 11 illustrates another exemplary delivery device in which embodiments of the present disclosure may be employed;

FIG. 12 illustrates an exemplary embodiment of a plurality of sequential lock segments according to an embodiment of the present disclosure;

FIG. 13A illustrates an exemplary embodiment of adjacent locking segments mated when the sling is bent in accordance with an embodiment of the present disclosure;

FIG. 13B illustrates another exemplary embodiment of adjacent locking segments mated when the sling is bent in accordance with an embodiment of the present disclosure;

FIG. 14 illustrates an exemplary embodiment of a plurality of locking segments with ball joints according to an embodiment of the present disclosure;

FIG. 15 illustrates an exemplary embodiment of a plurality of locking segments with spacers strung on a wire in accordance with an embodiment of the present disclosure;

FIG. 16A illustrates an exemplary embodiment of a hollow locking segment according to an embodiment of the present disclosure;

FIG. 16B illustrates an exemplary embodiment of a hollow locking segment with a ball joint according to an embodiment of the present disclosure;

FIG. 16C illustrates an exemplary embodiment of the plurality of hollow locking segments of FIG. 16A, according to an embodiment of the present disclosure;

FIG. 16D illustrates another exemplary embodiment of the plurality of hollow locking segments of FIG. 16C when the sling is bent in accordance with embodiments of the present disclosure;

FIG. 17 illustrates another exemplary embodiment of a plurality of sequential lock segments according to an embodiment of the present disclosure;

FIG. 18 illustrates an exemplary embodiment of a sling formed from a tube in which a plurality of sequential locking segments are disposed within the tube, according to embodiments of the present disclosure;

FIG. 19A is a graph showing radius and slope along the length of a curved chain spherical sequential locking segment in accordance with an embodiment of the present disclosure;

FIG. 19B is a graph showing the radius and slope of the length of a tapered sequential locking segment along a curved chain in accordance with an embodiment of the present disclosure;

FIG. 19C is a graph showing radius and slope along the length of a curved chain hollow taper sequence lock segment according to an embodiment of the present disclosure;

FIG. 20A illustrates an exemplary embodiment of a hollow tapered locking segment with a notch in accordance with an embodiment of the present disclosure;

FIG. 20B is another view of the hollow tapered locking segment of FIG. 20A in accordance with an embodiment of the present disclosure;

FIG. 21 illustrates an exemplary embodiment of a hollow tapered locking segment with a spacer according to an embodiment of the present disclosure;

FIG. 22A illustrates an exemplary embodiment of radiopaque markers on the distal end of a delivery device, a buckle holder, and a second end of a sling according to an embodiment of the present disclosure;

FIG. 22B illustrates another exemplary embodiment of the radiopaque marker of FIG. 22A, in accordance with embodiments of the present disclosure;

FIG. 22C illustrates another exemplary embodiment of the radiopaque marker of FIG. 22A, in accordance with embodiments of the present disclosure;

FIG. 22D illustrates another exemplary embodiment of the radiopaque marker of FIG. 22A, in accordance with embodiments of the present disclosure;

FIG. 23A illustrates an exemplary embodiment of radiopaque markers on the distal end of a delivery device, a buckle holder, and a sling insertion cable according to an embodiment of the present disclosure;

FIG. 23B illustrates another exemplary embodiment of the radiopaque marker of FIG. 23A, in accordance with embodiments of the present disclosure;

FIG. 23C illustrates another exemplary embodiment of the radiopaque marker of FIG. 23A, in accordance with embodiments of the present disclosure; and

Fig. 23D illustrates another exemplary embodiment of the radiopaque marker of fig. 23A, according to an embodiment of the present disclosure.

Detailed Description

The present disclosure relates to methods and apparatus for improving cardiac function. While the present disclosure provides an example of repositioning papillary muscles by encircling a band around a plurality of papillary muscles, it should be noted that aspects of the present disclosure are not limited in their broadest sense to encircling a band around a plurality of papillary muscles. Instead, it is contemplated that the foregoing principles may also be applied to other devices that improve cardiac function. In addition, looping can also occur through multiple spaces between the trabeculae, pulling multiple papillary muscles closer to each other and repositioning the papillary muscles. The multiple spaces between the trabeculae may be located along the wall of the heart ventricle. Thus, looping the band through multiple spaces between the trabeculae and tightening the band in a single loop may pull the heart chamber wall inward, repositioning the papillary muscles and pulling the papillary muscles closer to each other.

The term "band" generally refers to any element that is capable of partially or completely encircling a desired anatomical structure. For example, the band may be an element that is capable of partially or completely encircling a plurality of papillary muscles in the heart ventricle in order to bring the papillary muscles closer to each other. As shown in fig. 3, a band encircling a plurality of papillary muscles is one example of a device for repositioning papillary muscles according to the invention. Looping may include partially or completely surrounding one or more papillary muscles. As described above, looping may additionally or alternatively include passing the ribbon through multiple spaces between the trabeculae. Furthermore, the terms "protuberance" and "protuberance" generally refer to any protrusion from the surface of the strap upon which a clasp may lock to form a loop. Thus, the terms "bump" and "protrusion" may be used interchangeably.

Referring to fig. 1A-1C, an exemplary apparatus 100 for repositioning papillary muscles according to the present disclosure may include a strap 110. The strap 110 can include a first end 120 and a second end 130. The band 110 may be placed around at least one, optionally at least two papillary muscles within the heart chamber. As shown in fig. 1A-1C, the band 110 may be selectively configured between an elongated configuration in which the first end 120 is disconnected from the second end 130 and a looped configuration in which the band 110 forms a loop. In some embodiments, the band may be sized to simultaneously encircle multiple papillary muscles, forming a loop around the papillary muscles and pulling the papillary muscles toward each other. The term "belt" may include a tube. Alternatively, the band 110 may be a tube. In some embodiments, a portion of the band 110 may be a tube, while another portion of the band 110 may not be a tube. As shown in fig. 1A-1C, the strap 110 may have different widths along different portions of its length.

In some embodiments of the present disclosure, the band 110 may be made of Polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), dacron, and/or any other bio-inert synthetic material having suitable tensile strength for drawing papillary muscles closer. In other embodiments, the band 110 may be manufactured by extrusion, knitting, weaving, braiding, or any other method of forming a biologically inert synthetic material into a band or tubular band. The belt 110 may be elastic, inelastic, partially elastic, or any combination thereof. For example, a portion of the belt 110 may be elastic while another portion of the belt 110 may be inelastic. In some embodiments, the band 110 may be made of more than one material. For example, one portion of the strap 110 may be made of one material, while another portion of the strap 110 may be made of a different material. Alternatively, the strap 110 may be made of biological material from a patient, from another human donor, or from animal-derived material.

At or near the first end 120 of the strap 110, at least one fastener, such as a clasp 150, may be provided. For example, the retaining ring 150 may be formed from a crown-shaped cut nitinol tube. Additionally or alternatively, the grommet 150 may be formed in the form of a cylinder having a plurality of tabs protruding from one end. The clasp 150 may be configured to transition from an open configuration (an example of which is shown in fig. 1A) to a closed configuration (an example of which is shown in fig. 1B and 1C), and vice versa. In the closed configuration, as shown in fig. 1B, the tabs of the clasp 150 can be bent inward toward the center of the cylinder to form a clasp that grips a portion of the strap 110 that passes through the clasp 150. The wings may be sharpened at the distal end to securely hold and/or pierce the material of the band 110 in the closed configuration. Alternatively, the tabs may be flat or rounded at the ends to close between one or more protrusions on the strap 110 and prevent the protrusions from passing through the buckle 150. In the open configuration, as shown in fig. 1A, the tab may be straight with the wall of the cylinder and allow the strap 110 to pass through the buckle 150. During positioning and adjustment of the strap 110, the tab may be biased toward the closed configuration and may be resiliently flexed into the open configuration. Upon actuation of a buckle actuator (not shown), the tab may be allowed to return to the closed configuration.

As shown in the example of fig. 1A-1C, a clasp 150 may be attached to the first end 120 of the strap 110. In some embodiments, the band 110 may be a tube. Thus, the buckle 150 may be located within the first end 120 of the strap 110. The grommet 150 may include one or more cutouts in the tube wall. The wire or loop may be wrapped around the outside of the band 110 over one or more cuts in the tube, pushing the material of the band 110 into the cuts in the tube. The foregoing features may permanently or semi-permanently connect the strap 110 to the buckle 150.

The second end 130 of the strap 110 can further include protruding elements 140 (also referred to as "graspable elements") and the clasp 150 can be closed between the protruding elements 140. The protruding element 140 may be an object, a soft or hard ball made of plastic, metal and/or polymer, a protrusion, a spike or any material that can be grasped by a clasp. In some embodiments, as shown in fig. 1B and 1C, the protruding element 140 cannot pass back through the closed clasp 150. In some embodiments, protruding element 140 may comprise a hard ball located within band 110, band 110 being a tube. The band 110 may be sandwiched between hard balls by loops, wires or ropes around the outside of the band 110 so that the hard balls cannot move within the band 110. Any number of protrusions may be manufactured at the second end 130 of the strap 110, and the clasp 150 may be locked closed between any of the protrusion members 140 or past the last protrusion member 140, thereby locking in any of a plurality of positions along the strap 110.

In some embodiments of the present disclosure, the grommet 150 may be connected to the distal end 160 of the delivery device 190 such that when the grommet 150 is actuated, the grommet 150 automatically disconnects from the delivery device 190. The inner and outer diameters of the distal end 160 of the delivery device 190 may be similar to the inner and outer diameters of the grommet 150. Further, the distal end 160 of the delivery device 190 may be cut with a cutting pattern that complements the tab shape of the buckle 150 such that when the buckle 150 is in the open configuration and the tab is bent into the cylindrical shape of the tube, the tab of the buckle 150 may lock into the cutting pattern of the distal end 160 of the delivery device 190, as shown in fig. 1A. When the clasp 150 is allowed to return to the closed configuration, the tab may flex inwardly, thereby breaking away from the cutting pattern at the distal end 160 of the delivery device 190. Thus, the buckle 150 and strap 110 may be disconnected from the delivery device 190, as shown in fig. 1B.

As shown in the example of fig. 1A and 1B, the device 100 may also include a clasp actuator 180 and/or a pull wire 170. The pull wire 170 can be coupled to a clasp retainer ring 165 located within the clasp 150 and within the distal end 160 of the delivery device 190 such that the clasp retainer ring 165 can retract from the clasp 150 upon actuation of the clasp by the clasp actuator 180. Thus, upon actuation of the buckle actuator 180, the buckle 150 may transition to a closed configuration in which the buckle 150 is closed between the protruding elements 140 at the second end 130 of the strap 110. In this way, the buckle 150 and the strap 110 may be disconnected from the delivery device 190, thereby forming a loop.

According to another embodiment of the present disclosure, the band 110 may be configured to pass through the space between the papillary muscles and the trabeculae between the ventricular wall. For example, fig. 3 shows a device 300 that includes a strap 310 having a clasp 320. The band 310 may be configured to pass through the space between the papillary muscles 340 and the trabeculae 330 between the walls of the ventricle 350. In some embodiments of the present disclosure, after the strap has passed around one, two, or more papillary muscles, two locations along the strap may be attached together to form a loop. In some embodiments, the attachment is configured such that the strap or ring pulls the papillary muscles toward each other.

In some embodiments of the present disclosure, the band may be configured such that it does not contact the opposite face of the papillary muscle. For example, the band may contact only the sides of the non-opposing surface of the papillary muscle. For example, fig. 3 shows that the band 310 only contacts the sides of the non-opposing surface of the papillary muscle 340. Alternatively, the straps may be configured to contact non-opposite sides of the papillary muscles and pull the papillary muscles toward each other.

In another embodiment of the present disclosure, the band may be configured to contact the papillary muscles such that there is no band material between opposing faces of the papillary muscles. For example, in fig. 3, the band 310 encircles the papillary muscles 340 such that there is no band material between the papillary muscles 340. Thus, the band 310 may be configured such that when positioned around the papillary muscles 340, no portion of the band 310 is interposed between the papillary muscles 340 around which the band 310 is positioned. In some embodiments, the band 310 may be configured such that when it pulls the papillary muscles 340 together, the papillary muscles 340 may contact each other without any portion of the band 310 or other foreign matter therebetween.

In some embodiments of the present disclosure, the two locations of attachment that form the strap into a loop may be at the first end and the second end of the strap. The term "attached" may refer to a clasp or any material used to hold the ends of a strap together to form a loop. Referring back to fig. 1A, for example, two locations forming the attachment of the strap 110 may be at the first end 120 and the second end 130 of the strap 110. In some embodiments of the present disclosure, two locations of attachment that form the strap 110 into a loop may be proximate the first end 120 and the second end 130 of the strap 110. Alternatively, the attachment of the strap 110 to form a loop may be closer to the first end 120 than the second end 130. In other embodiments, the attachment of the strap 110 to form a loop may be in a fixed position relative to the first end 120 of the strap 110 and its position relative to the second end 130 of the strap 110 may be varied in order to adjust the size of the strap 110.

For example, fig. 2 shows an apparatus 200 that includes a belt 210. Strap 210 includes a first end 230, a second end 220, and a clasp 240. Clasp 240 may be in a fixed position relative to first end 230 of strap 210. The position of clasp 240 relative to second end 220 of strap 210 may be varied to adjust the size of the loop formed by strap 210. Alternatively, the attachment forming the strap may attach one end of the strap to any location along the strap. In yet another embodiment, the attachment forming the strap may attach any two locations along the strap together.

The strap may also include a buckle according to embodiments of the present disclosure. For example, fig. 1A-1C illustrate a strap 110 including a clasp 150, the clasp 150 forming an attachment between a first end 120 and a second end 130 along the strap 110 to form a loop. In some embodiments, the buckle 150 may be provided with the strap 110 and attached to the strap 110. In other embodiments, the buckle 150 may be attached to or near the first end 120 of the strap 110. In other embodiments, the buckle 150 may not be attached to the strap 110 until the buckle 150 is actuated. When the clasp 150 is actuated, the clasp 150 may be attached to the first end 120 and the second end 130 of the strap 110 to form a loop (an example of which is shown in fig. 2). In some embodiments of the present disclosure, the device 100 may further include a clasp actuator (not shown) that may be used to actuate the clasp 150. The position of the buckle 150 relative to the second end 130 of the strap may be varied to adjust the size of the loop formed by the strap 110 until a buckle actuator (not shown) actuates the buckle 150. For example, once actuated, the clasp 150 may transition from an open configuration (an example of which is shown in fig. 1A) to a closed configuration (an example of which is shown in fig. 1B and 1C). Alternatively, the length of the loop formed by the band 110 may be adjusted within a range of at least 5mm, at least 8mm, or at least 10 mm.

In some embodiments, the buckle may be attached to the wall of the strap near one end of the strap. For example, fig. 2 shows clasp 240 attached to a wall of strap 210 near first end 230. For example, prior to implantation in the heart, a clasp 240 may be attached to the band 210 at the first end 230. The second end of the strap may pass through or past the clasp 240. For example, referring to fig. 2, second end 220 of strap 210 may pass through or past clasp 240. Upon actuation of clasp 240 after implantation in the heart, the actuation may cause clasp 240 to grasp a portion of strap 210 that has passed through or past clasp 240, thereby locking second end 220 of strap 210 in a fixed position relative to first end 230 of strap 210. Thus, a ring can be formed.

The width or diameter of the belt may be between about 2mm and about 5 mm. For example, the width or diameter of the belt may be between about 3mm and about 4 mm. The width of the belt may be constant along the length of the belt. Alternatively, the width of the belt may vary along its length, with one end being larger than the other. For example, the ends of the buckle-connected strap may have a greater width than the ends of the strap inserted into the buckle. Thus, the end of the strap inserted into the buckle can have a smaller width.

In some embodiments, the band may comprise a tube. In some embodiments, the clasp may be located within the first end of the strap and/or may be attached to the wall of the strap near the first end. For example, fig. 2 shows clasp 240 attached to a wall of strap 210 near first end 230. The second end of the strap may pass through or past the buckle in the lumen of the strap. For example, the second end 220 of the band 210 may pass through or past the clasp 240 in the interior cavity of the band 110. Upon actuation of clasp 240 after implantation in the heart, the actuation may cause clasp 240 to grasp a portion of strap 210 that has passed through or past clasp 240, thereby locking second end 220 of strap 210 in a fixed position relative to first end 230 of strap 210. Thus, a ring can be formed. In some embodiments, the clasp may be positioned within the band such that the band prevents the clasp from contacting heart tissue. For example, fig. 3 shows a device 300 that includes a strap 310 and a clasp 320 positioned within the strap 310. The band 310 may prevent the retaining ring 320 from contacting surrounding tissue in the heart chamber 350.

According to an exemplary embodiment of the present disclosure, the clasp may be configured to secure the length of the ring to correspond to a unique anatomy of the patient. In addition, the clasp may be configured to be actuated within the heart of the patient. Thus, the clasp may be configured to be selectively actuatable to fix the length of the loop formed by the band such that the loop corresponds to a unique anatomy of the patient. As noted above, the clasp may have a variety of mechanical configurations. For example, during insertion and positioning of the strap within a patient's heart, the buckle may be in an open configuration (an example of which is shown in fig. 1A). For example, in the open configuration, the insert cable (not shown) and the second end of the strap may be free to move through or past the buckle. Once the strap is properly positioned and adjusted, the buckle actuator can be used to actuate the buckle, reconfiguring it into a closed configuration (examples of which are shown in fig. 1B and 1C). For example, in a closed configuration, the buckle may grasp a portion of the strap that has passed through or over the buckle, thereby preventing the strap from moving relative to the buckle and forming a loop.

The clasp may be a clip, grasper, latch, fastener, buckle, or any other type of clasp capable of attaching one location of the strap to another location of the strap. Fig. 4 illustrates various exemplary embodiments of a clasp in an open and closed configuration. For example, as shown in fig. 4, the clasp may be a bear clip clasp 410, a clip clasp 420, a fastener clasp 430, a self-locking zipper strip clasp 440, a buckle clasp 450, a fastener clasp 460, or any other type of clasp capable of attaching one position of a strap to another position of the strap.

In some embodiments, the retaining ring may be made of metal, such as spring steel, stainless steel, and/or nitinol. In other embodiments, the clasp may be made of a polymeric material or any other material having the mechanical properties required to provide the open and closed configurations. In some embodiments, the clasp may be biased toward a closed configuration and may be elastically deformed into an open configuration until actuated by a clasp actuator. For example, the clasp actuator may allow the clasp to return to a closed configuration. The second end of the strap may pass through or past the clasp in the open configuration. Thus, when the second end of the strap is properly positioned, the buckle actuator may allow the buckle to resiliently return to the closed configuration so that the buckle may grasp the strap and lock the strap in place, thereby forming a loop.

In other embodiments, the clasp may be biased toward an open configuration and may be deformed into a closed configuration when actuated by a clasp actuator. For example, a clasp actuator may force the clasp into a closed configuration. In such embodiments, the second end of the strap may pass through or past the buckle in the open configuration. When the second end of the strap is properly positioned, the buckle actuator can force the buckle into a closed configuration so that the buckle can grasp the strap and lock the strap in place, thereby forming a loop.

According to another embodiment of the present disclosure, the clasp may be a cylinder with a resilient member extending inwardly into the cylinder interior. In the open configuration, the resilient element of the clasp may be held outwardly in or adjacent to the wall of the cylinder. For example, fig. 5 illustrates various embodiments of a clasp that may be cylindrical. For example, the grommet 510 may be manufactured from a cut tube, wherein the resilient element is cut from the tube wall and then bent inwardly. Clasp 510 may be configured to grasp a portion of the strap at any location along the strap, or clasp 510 may be configured to grasp a graspable member or feature located at a particular location along the strap. The clasp 510 may be held in the open configuration by a tube (not shown) placed within the clasp 510. The clasp 510 may be actuated back to its closed configuration by removing the tube from the clasp 510.

Alternatively, the clasp 520 may be made of a bending wire, such as a coil spring, and the elastic element may be a portion of the bending wire configured to extend inwardly into the interior of the cylinder. The clasps 510 and 520 may be flexible such that the strap in the area of the clasps 510 and 520 remains flexible. Such flexibility may be achieved by a design of a bend line spring or by cutting a cut in the tube wall configured to increase the flexibility of the tube.

In another embodiment, the retaining ring may be a disk having a plurality of cutouts forming a plurality of blades. The plurality of blades may rotate out of the plane of the disk. For example, FIG. 6 shows a grommet 610 having a plurality of cuts 620 forming a plurality of blades 630. The perimeter of the clasp 610 may remain intact and the blade 620 may be attached to the clasp 610 near the perimeter such that when the blade 620 rotates out of the plane of the clasp 610, the blade 620 may leave an open channel 640 through the middle of the clasp 610. The blade 620 may be configured such that when an object (not shown) passes through the open channel 640 in one direction through the middle of the grommet 610, the blade 620 may press against the object and prevent or reduce the likelihood of the object returning through the open channel 610 in the opposite direction. In another embodiment, the blade 620 may include at least one spike 650 in a region that contacts an object (not shown) passing through the open channel 640. Thus, if the passing object is able to be penetrated, spike 650 may penetrate the object and increase the ability of clasp 610 to grasp the object passing through clasp 610.

Although only one clasp 610 is shown in fig. 6, multiple clasps 610 may be used together to increase the strength with which the clasps 610 can grasp objects passing through them. Alternatively, a single clasp 610 may include multiple layers of blades 630, thereby increasing the strength with which the clasp 610 can grasp objects passing through it. Such a multi-layer buckle can be made flexible so that a portion of the strap to which the buckle is attached can remain flexible. The retaining ring 610 may be manufactured by cutting or punching the shape of the retaining ring 610 from a flat plate, or by cutting the shape of the retaining ring 610 from a tube and bending the blades 630 inward.

In some embodiments, the clasp may be made from multiple panels. For example, FIGS. 7A-7B illustrate a clasp 710 that includes a plurality of panels 720. The panel 720 may include a plurality of spikes 730 protruding from the panel 720. The spikes 730 may be pressed against each other to grip, for example, a strap passing between the panels 720. The panels 720 may be connected at their edges by resilient members that urge the panels 720 against each other. The panels 720 may be flexible such that they naturally flatten each other, but may elastically deform into a curved shape, as shown by way of example in fig. 7A, 7B.

The grommet 710 may be cut from a tube having the panel 720 and the resilient members holding the panel 720 together at their edges may also be cut from the same tube. Spikes 730 protruding from the panel 720 may be cut from the wall of the panel 720 and bent inward to form protruding spikes 730. By placing an inner tube (not shown) between the panels 720, the spikes 730 and/or the panels 720 can be elastically deformed outwardly into the open configuration of the clasp 710. Upon removal of the inner tube, the spike 730 and the panel 720 may return to a closed configuration, wherein the spike 730 may protrude perpendicular to the panel 720 and the panels 720 may press against each other.

In other embodiments, the clasp may be formed of a ring with spikes protruding from the ring. For example, fig. 7C-7D illustrate a clasp 740 including a ring 750, the ring 750 having a plurality of spikes 760 protruding from the ring 750. In a closed configuration (examples of which are shown in fig. 7C-7D), spike 760 may span a portion (fig. 7C) or all (fig. 7D) of the interior of ring 750. In the open configuration, spike 760 may rotate out of the plane of ring 750 and may allow an object, such as a strap, to pass through the center of ring 750. During positioning and adjustment of the band around the papillary muscles, spike 760 may be biased toward a closed configuration and may resiliently rotate to an open configuration. Spike 760 may then be allowed to return to the closed configuration upon actuation of the buckle actuator. Alternatively, spike 760 may be biased toward an open configuration and may be forcibly bent into a closed configuration upon actuation by a buckle actuator. In some embodiments, spike 760 may be configured to abut ring 750 or a protrusion (not shown) extending from ring 750 in a closed configuration such that spike 760 does not rotate through the plane of ring 750.

As described above, the buckle may be locked in the closed configuration upon actuation of the buckle actuator. In some embodiments of the present disclosure, the clasp actuator may be configured to be able to remotely actuate the clasp, for example from outside the heart. In other embodiments, the buckle actuator may be configured to actuate the buckle from outside the patient's body. Thus, the clasp actuator may be configured to enable a user to actuate the clasp from a position remote from the clasp.

For example, fig. 8 illustrates a clasp actuator 800 that may enable a user to actuate a clasp 840 from outside of a body 830. The buckle actuator 800 may include a pull wire, a rotating shaft, a rotating tube, a movable shaft, a movable tube, an electrical actuator, a pneumatic actuator, a hydraulic actuator, or any other device that provides actuation remotely to actuate a buckle located within the heart from outside the body. For example, the clasp actuator 800 may be configured to allow actuation of the clasp 840 from outside the body 830 via the flexible conduit 820. In some embodiments, the clasp actuator 800 may further include a trigger 810 external to the body 830, which may be used to actuate the clasp 840 internal to the heart.

In some embodiments of the present disclosure, the first end of the band may be mounted on a delivery device to encircle the band around the papillary muscles. The delivery device may incorporate some or all of the buckle actuator within the device. Furthermore, the delivery device may comprise a rigid or flexible tube. Alternatively, the delivery device may comprise a tube having a rigid portion and a flexible portion. The delivery device may include a tube or catheter passing through the side wall of the band, the tube or catheter configured to form a loop around the papillary muscle.

For example, fig. 9 shows an exemplary delivery device 910 coupled near a first end 980 of a belt 970. The band 970 may include an opening 930 in a sidewall of the band 970 through which the removable delivery device 910 may pass. The delivery device 910 may pass through the wall of the band 970 near the first end 980 such that a portion of the delivery device 910 is within a portion of the band 970 near the first end 980. The portion of the band 970 that includes the delivery device 910 within the band 970, such as the distance from the first end 980 of the band 970 to the location where the delivery device 910 passes through the opening 930 of the band 970, may be in the range of about 5mm to about 25 mm. For example, the distance may be in the range of about 10mm to about 15 mm. In some embodiments, the grommet 940 may be located within 25mm, 15mm, 10mm, or 5mm of the first end 980 of the strap 970. The grommet 940 may be located within the portion of the band 970 having the delivery device 910 therein. In some embodiments, components of the buckle actuation mechanism, such as a pull wire or buckle retainer ring that engages the buckle, may be located in a portion of the delivery device 910 within the band 970. A grommet 940 may be located at one end of the delivery device 910. The other end of the delivery device 910 may be located outside the patient. In other embodiments, the buckle actuation mechanism may comprise an elongate member that may pass through the delivery device 910.

The delivery device 910 may also include an area proximate to where the delivery device 910 passes through the opening 930 of the band 970, which may be flexible and/or actively deflectable. The deflection of deflectable region 920 may be controllable between at least 0 degrees and 90 degrees. In some embodiments, the delivery device 910 may further include an insertion cable threader 960 protruding from both ends of the delivery device 910. One end of the threader 960 protruding from one end of the delivery device 910 may include a grasper 950 configured to grasp an insertion cable (not shown) coupled to the band 970. In some embodiments, grasper 950 may removably grasp an insertion cable coupled to band 970. The other end of the grasper 960 protruding from the other end of the delivery device 910 may be configured to be pulled to pull an insertion cable (not shown) through the delivery device 910. The insertion cable may be released from the threader 960 after being pulled through the delivery device 910.

In some embodiments, an insertion cable coupled to the ribbon may be provided to assist in inserting the ribbon into the heart. For example, fig. 10 shows a device 1000 that includes an insertion cable 1050 coupled to a strap 1010. Insertion cable 1050 can facilitate insertion of strap 1010 around the heart and papillary muscles. In some embodiments, an insertion cable 1050 may assist in inserting the strap 1010 into the clasp 1040.

According to embodiments of the present disclosure, the distal end of the insert cable 1050 may be removably connected to the second end 1030 of the strap 1010. The insert cable 1050 may be configured to adjust the size of the loop formed by the band 1010 encircling the papillary muscle. The insert cable 1050 may be flexible such that the insert cable 1050 may help guide the tape 1010 to form a loop around papillary muscles. The proximal end of insertion cable 1050 may be configured to pass through the space between the papillary muscles and the trabeculae between the ventricular walls. In addition, when the clasp 1040 is in the open configuration, the insert cable 1050 may be fitted into the first end 1020 of the strap 1010 and pass through or past the clasp 1040. Alternatively, the insertion cable 1050 may be fitted to the distal end of a delivery device (an example of which is shown in fig. 9), which may be located within the first end 1020 of the strap 1010.

In alternative embodiments, the patch cable 1050 may also include a patch cable release trigger (not shown) located at or near the proximal end of the patch cable 1050. The distal end of the insert cable 1050 may be configured to separate from the second end 1030 of the strap 1010 upon actuation of the insert cable release trigger. In some embodiments, the insertion cable release trigger may be a proximal end of a wire or tube (not shown) extending through the lumen of the insertion cable 1050 that is pulled, pushed, rotated, or otherwise manipulated to actuate release of the insertion cable 1050.

The strap 1010 may be releasably connected to the insert cable 1050. For example, the patch cord may be releasably connected to the strap 1010 by a patch cord adapter 1060. A patch cable adapter 1060 may be attached to the second end 1030 of the strap 1010. In other embodiments, the patch cable adapter 1060 may be permanently attached to the second end 1030 of the strap 1010, and the patch cable 1050 may be removably attached to the patch cable adapter 1060.

In some embodiments, at least a portion of the band may be preloaded into the tube. For example, fig. 11 shows at least a portion of band 1110 preloaded into tube 1120. Alternatively, at least a portion of the band 1110, at least a portion of the insert cable 1170 attached thereto, and at least a portion of the attached delivery device 1180 may be preloaded into the tube 1120.

Referring back to fig. 10, the band 1010, delivery device (not shown), and insertion cable 1050 may be configured to be inserted into the heart via a transthoracic approach, a transarterial approach, a transvenous approach, a transarterial/transaortic approach, a transvenous/transseptal/transmitral approach, or any other surgical or minimally invasive approach to the heart.

In some embodiments, a buckle 1040 may be attached at or near the first end 1020 of the strap 1010 and may be configured to grasp the strap 1010 at a location where the strap 1010 passes through or past the buckle 1040. Thus, the amount of belt adjustment required to form a loop of a desired circumference may be independent of the length of the clasp 1040.

As described above, the clasp 1040 may be attached at or near the first end 1020 of the strap 1010 and may be configured to grasp a graspable member or feature located at or near the second end 1030 of the strap 1010 or anywhere along the strap 1010. In other embodiments, multiple graspable members or features may be located at multiple locations along the strap 1010. The clasp 1040 may be configured to grasp a graspable member or feature at a plurality of locations or at any location along the length of the clasp 1040. In some embodiments, the amount of strap adjustment required to form a loop of a desired circumference may depend on the length of the clasp 1040 and the number of locations of the graspable member or feature, as the graspable member or feature may need to be grasped within the clasp (examples of which are shown in fig. 1A-1C).

In some embodiments, the clasp 1040 may interact with the material of the strap 1010 itself to achieve grasping. In other embodiments, there may be a feature or feature in or on the strap 1010 that the clasp 1040 may grasp. The graspable member or feature that the clasp 1040 may grasp may be moved relative to the position of the second end 1030 of the strap 1010.

The clasp 1040 may be attached to the wall of the strap 1010 at or near the first end 1020 of the strap 1010 using glue or adhesive. Additionally or alternatively, the clasp 1040 may be attached to the wall of the band 1010 using a fusion or thermal bond, attached to the wall of the band 1010 using stitching, sewing, or sewing, attached using clasp elements that couple the clasp 1040 to the wall of the band 1010, or any other attachment method or combination of attachment methods that may attach the clasp 1040 to the wall of the band 1010.

For example, fig. 11 shows a band 1110 that includes a plurality of graspable members 1130 at or near a second end 1150 of the band 1110. The graspable member 1130 may be an object, a soft or hard ball made of plastic, metal, and/or polymer, a protrusion, a spike, or any material capable of being grasped by a clasp. At or near the first end 1160 of the band 1110, a clasp 1140 may be provided that is configured to grasp at least one graspable member 1130. The second end 1150 of the band 1110 may be pulled over the first end 1160 of the band 1110. The buckle 1140 may then be configured to transition from the open configuration to the closed configuration upon actuation of the buckle actuator to grasp the at least one graspable member 1130 to form a loop of a desired circumference, preferably based on the patient's unique anatomy.

Referring back to fig. 1A-1B, in some embodiments, the distal end of the delivery device 190 can include a clasp retainer ring 165 within the outer tube of the delivery device 190. The distal end of the outer tube may be proximal to the clasp 150 and have a diameter such that the clasp 150 cannot fit into the outer tube. The clasp retainer ring 165 may extend distally beyond the distal end of the outer tube and be positioned within the clasp 150 to retain the clasp 150 in an open configuration (an example of which is shown in fig. 1A). Thus, the buckle 150 may be biased toward the closed configuration and may be held in the open configuration by a buckle retainer ring 165 located within the buckle 160. Actuation of the buckle 150 may include pulling the buckle retainer ring 165 proximally relative to the outer tube such that the buckle retainer ring 165 retracts from within the buckle 150 into the outer tube, allowing the buckle 150 to return to a closed configuration (an example of which is shown in fig. 1B). Additionally or alternatively, a pull wire or tube may be connected to the buckle retainer ring 165 and may extend through the delivery device 190 to the proximal end of the delivery device 190. At the proximal end of the delivery device 190, a pull wire or tube may be connected to a trigger that may pull the pull wire proximally relative to the delivery device 190 to retract the buckle retainer ring 165 into the outer tube. After actuation of the buckle 150, the delivery device 190 may be removed from the band 110.

In some aspects, the insert cable (an example of which is shown in fig. 10) may include a tube with the wire positioned within the tube. The distal end of the tube may have a longitudinal slit dividing the tube wall into a plurality of fins. The fins may have a thickened wall at their distal ends so that when the wire is inside the tube, the distal end of the tube may not fit through a hole of the same diameter as the outer diameter of the tube. However, when the wire is removed from the distal end of the tube, the distal end of the tube may be able to fit through a hole of the same diameter as the outer diameter of the tube. In other embodiments, the distal end region of the wire that holds the tab outward may have a larger diameter than the rest of the wire. In some aspects, the tube may be a coil having a solid tubular region at a distal end. The coil may be tightly wound to avoid compression and have a wire or ribbon threaded through the coil connected at both ends to avoid stretching.

According to one embodiment of the invention, the fins may be formed by cutting the tube wall near the distal end. Thickening of the distal wall of the fin may be created by bending the distal end of the fin back onto itself one or more times. The distal portion of the tube of the insertion cable forming the tab may be made of metal, polymer or plastic or any other material capable of forming a tab with a thickened wall.

In other aspects, the airfoil may have a radially outward step prior to the thickened portion. Thus, if excessive force is not applied to the wire holding the fins outwardly, the insertion cable is not allowed to pass through the hole having the same diameter as the outer diameter of the tube. Additionally or alternatively, the fins may be biased radially inward so that when the wire is not located in the region of the tube containing the fins, the fins may bend inward and the tube may pass freely through a hole of the same diameter as the outer diameter of the tube.

Referring back to fig. 10, a patch cable adapter 1060 may be attached to the second end 1030 of the strap 1010. For example, the insert cable adapter may have a passage (not shown) therethrough that has a diameter equal to or slightly greater than the outer diameter of the tube of the insert cable 1050. The region of the channel may have a diameter large enough to fit the distal end of the tube with the wire therein. The diameter of the tube, the thickened fins at the distal end of the tube, and the narrow and wide regions of the channel in the adapter may be configured such that when the outer tube is within the channel in the adapter and the wire is within the distal end of the tube, the tube may be locked in the adapter because its distal end cannot fit through the narrow region of the channel. In this way, when the wire is removed from the distal end of the tube, the tube can then be removed from the adapter. The wire may extend through the tube, additionally or alternatively, beyond the proximal end of the tube such that the wire may be pulled from the proximal end to retract the wire from the distal end of the tube in order to separate the insertion cable from the adapter. Additionally or alternatively, the proximal end of the wire may be attached to a puller, which may be removably attached to the proximal end of the tube. Thus, when the puller is removed and pulled away from the tube, the puller can then pull the wire, retracting the wire from the distal end of the tube. In some aspects, the puller may be removably attached to the proximal end of the tube by screwing or screwing into the distal end of the tube. Alternatively, the puller may not be at the distal end of the tube, but may be located in the middle of the tube near the distal end.

In some aspects, the drop cable may be removably connected to the drop cable adapter by one or more wires, fibers, or other elongated elements that pass through holes in the tube wall and back into the tube through the drop cable adapter and holes in the tube wall. Wires, fibers or other elongate elements may extend through the tube and may be pulled at or near the proximal end of the tube to remove them from the bore, thereby releasing the connection of the insert cable with the insert cable adapter. The insert cable may be a suture, rope, fiber or wire that is cut to separate the insert cable from the second end of the strap. The insert cable may be a flexible torque cable or torque tube with a screw at its distal end. The screw of the distal end of the insert cable may be threaded into an insert cable adapter connected to the second end of the strap. Thus, rotating the proximal end of the insert cable may cause the distal end of the insert cable to unscrew from the insert cable adapter and disengage from the strap. In other embodiments, the flexible torque cable or torque tube may be covered by a flexible braided tube to enhance its tensile strength. The flexible braided tube may be made of metal, polymer, wire or any other biocompatible material that may be made into a fine braid and used to cover a torque cable or torque tube, thereby increasing tensile strength.

According to another embodiment of the present disclosure, a cardiac implant is provided. The cardiac implant may include a papillary muscle band formed from a tube having an opening in a sidewall of the tube and a removable catheter passing through the opening. The cardiac implant may additionally include a buckle associated with the band. The clasp may be configured to be actuated by an elongate member passing through the removable catheter. Upon actuation, the clasp may attach two locations along the strap to each other, thereby forming the strap into a loop. The clasp may be located at the distal end of the catheter and the proximal end of the catheter may be located outside the patient. The removable catheter may be configured to be removed from the tube after actuation of the clasp.

As described above, the band may be configured to contact a non-opposing surface of the papillary muscle. The band may be configured to encircle multiple or a cluster of papillary muscles, thereby pulling the papillary muscles toward each other, and no portion of the band is interposed between the papillary muscles (an example of which is shown in fig. 3).

According to another embodiment of the present disclosure, a cardiac implant is provided. The cardiac implant may include a papillary muscle band having a first end and a second end and being selectively configurable between an elongated configuration in which the first end is disconnected from the second end and a looped configuration in which the band forms a loop. The cardiac implant may further include a clasp attached to the band, the clasp being closer to the first end of the band than to the second end of the band. The implant may also include an elongate insertion cable removably connected to the second end of the strap. The papillary muscle strips may be configured to form a loop that simultaneously encircles a set of papillary muscles, and the elongate insertion cable may be configured to adjust the size of the loop. The band may be configured to contact a non-opposing portion of the papillary muscle. The strap may be configured to encircle a plurality of papillary muscles, thereby pulling the plurality of papillary muscles toward each other, and no portion of the strap is interposed between the papillary muscles. In some embodiments, the clasp may be selectively configurable between two configurations, an open configuration and a closed configuration. In the open configuration, the second end of the insert cable and strap may pass through the buckle. In the closed configuration, the area of the strap passing through the buckle may remain in place such that the strap cannot move relative to the buckle.

According to another embodiment of the present disclosure, the strap may include a sling including an actuatable buckle and a plurality of sequential locking segments configured to slide into the actuatable buckle. For example, as shown in fig. 12, the strap may include a sling 1200 and a plurality of sequential locking segments 1210. Each locking segment 1210 may include a raised region 1220 and an angled region 1230. Adjacent locking segments 1210 may be configured to flex relative to one another such that adjacent sloped regions 1230 can mate with one another and facilitate sliding of the locking segments 1210 into an actuatable clasp, such as clasp 240 of fig. 2 and/or clasp 1140 of fig. 11.

As shown in fig. 12, in the sloped region 1230, the radius of each locking segment 1210 may increase with increasing distance from the end 1240 of the sling 1200. Thus, in the sloped region 1230, the outer surface of the locking segment 1210 can have a positive slope. Conversely, in the raised region 1220, the radius of each locking segment 1210 may decrease with increasing distance from the end 1240 of the sling 1200. Thus, in the raised region 1220, the outer surface of the locking segment 1210 may have a negative slope.

In some embodiments, a clasp, such as an actuatable clasp, may lock onto the reduced radius of the raised area 1220. Thus, the greater positive slope of the sloped region 1230 can increase the force required to pull the sling 1200 into the buckle. Thus, the design of the locking segment 1210 may require minimizing the positive slope of the sloped region 1230 while maintaining sufficient protrusion on which the clasp may lock.

In some embodiments of the present disclosure, when the sling is bent, the cooperation of adjacent locking segments may reduce the size of the protrusion along the inside of the bent sling, thereby reducing the protrusion effect. For example, as shown in fig. 13A and 13B, when sling 1300 is bent, adjacent locking segments 1310 cooperate with each other, so that the size of protrusions 1320 decreases along inner side 1330 of bent sling 1300. Accordingly, when sling 1300 is bent and the size of protrusion 1320 is reduced, sling 1300 can more easily slide over the buckle.

According to some embodiments of the present disclosure, the locking segment may be tapered. For example, as shown in fig. 14, the locking segment 1410 may be tapered, and thus, the raised region 1420 and the sloped region 1430 may be formed from the tapered segment 1410. Additionally or alternatively, the plurality of locking segments 1410 may include individual locking members configured to fit together in a manner that allows the locking segments 1410 to flex relative to one another. For example, the plurality of locking segments 1410 may be assembled together with a ball joint 1440, a cylindrical socket joint, or any other similar type of joint capable of locking adjacent segments together while allowing the segments to rotate relative to one another in at least one plane.

In some embodiments, the plurality of locking segments may be strung on a belt, sling, wire, line, rope, cable, or the like. Alternatively, a spacer may be located between each locking segment. For example, as shown in fig. 15, sling 1500 includes a plurality of locking segments 1510 strung on a wire with spacers 1520 between the locking segments 1510. Multiple sequential locking segments 1510 may be individually coupled to the wire such that they cannot move along the wire. In some embodiments, the spacer 1520 may be strung on a line between adjacent locking segments 1510. In some embodiments, the spacer 1520 may be strung between some adjacent lock segments 1510, but not between each adjacent lock segment 1510. In some embodiments, a spacer 1520 may be coupled to the wire and hold the locking segment 1510 in place. Additionally or alternatively, only the first and last of the plurality of locking segments 1510 may be coupled to the wire on which they are strung. Thus, the first and last of the plurality of locking segments 1510 may be configured to hold the remaining locking segments 1510 in place. In yet another embodiment, the plurality of sequence lock segments 1510 may not be coupled to a wire. Instead, other components may be coupled to the wire at the ends of the plurality of locking segments 1510, and these components may be configured to hold the locking segments 1510 in place.

According to some embodiments of the present disclosure, the plurality of sequential locking segments may be integrally formed as a single piece. The single piece may include a region that is more flexible than the locking segment. The more flexible region may connect less flexible locking segments. In some embodiments, the more flexible regions connecting the locking segments may be made of a different material than that used to make the less flexible locking segments. Thus, the different flexibilities of the different regions may result from the use of different materials having different mechanical properties. Additionally or alternatively, the entire chain sequential locking section including the flexible region and the locking section may be made of the same material. Thus, different flexibilities of different regions may result from different thicknesses of the same material. For example, the more flexible region may comprise a first thickness of material and the locking segment may comprise a second thickness of the same material. The second thickness may be greater than the first thickness. That is, the locking section may be thicker than the flexible connection area.

In some embodiments, the sloped region of the locking segment may include a hollow interior. For example, as shown in fig. 16A and 16B, the locking segment 1600 may include a hollow interior 1610, such as an undercut. The hollow interior 1610 may allow each locking segment 1600 to rotate relative to the centerline of the chain sequential locking segment 1600. Thus, the size of the protrusion on the inner side of the curved sling may be reduced. For example, as discussed with respect to fig. 13A and 13B, when the sling of a plurality of locking segments is bent, adjacent locking segments may mate with each other, and thus, the size of the protrusions may decrease along the inside of the bent sling. Thus, the sling can more easily slide over the buckle. Similarly, fig. 16C shows sling 1620 of multiple sequential locking segments 1600 that have not been bent. In contrast, fig. 16D shows a curved sling 1620. As shown in fig. 16C and 16D, when sling 1620 of locking segment 1600 is bent, the size of protuberance 1630 is significantly reduced inside of bent sling 1620. The hollow interior 1610 of each locking segment 1600 may allow adjacent locking segments 1600 to better mate with one another as sling 1620 is bent, thereby helping to further reduce the size of the protrusions.

In some embodiments of the invention, the sloped region of the locking segment may expand in radius in only one plane or in only one direction. For example, as shown in fig. 17, the sloped region 1700 of the locking segment 1710 can be enlarged in radius in only one plane. When the sloped region 1700 expands in radius in only one plane, the bump effect may be substantially completely eliminated, except for some possible variation in force due to uneven bending. Further, when the sloped region 1700 expands in radius in only one plane, the locking strength of the buckle may be reduced due to the expansion of the protrusion 1720 of each locking segment 1710 in only one plane and within the thickness of each locking segment 1710.

In some embodiments of the present disclosure, the band may comprise a tube and the plurality of sequential locking segments may be disposed within the tube. For example, as shown in fig. 18, a plurality of sequential locking segments may be disposed within the tube 1800. The tube 1800 may be made of a soft, flexible material such that the clasp may close over the outer surface of the tube 1800 and securely lock onto the raised area of the locking segment disposed inside the tube 1800. In some embodiments, tube 1800 may be made of ePTFE, dacron, or any other biocompatible material that is soft and flexible. In some embodiments, one end of the tube 1800 may be connected to one end of a chain sequential locking segment. In other embodiments, one end of the tube 1800 may be connected to one end of a chain of consecutive locking segments by an adapter. For example, an adapter may be connected to one end of the chain sequential locking segment and one end of the tube 1800, thereby connecting the chain sequential locking segment to the tube 1800. In yet another embodiment, the location in the middle of the tube 1800 may be connected to the other end of the chain of continuous locking segments.

Fig. 19A-19C are graphs showing the radius and slope along the length of a curved chain spherical sequential locking segment, a tapered sequential locking segment, and a hollow tapered sequential locking segment, respectively. For example, as shown in fig. 19A, the upper graph shows the radius along the inside length of the curved chain spherical sequential locking segments. The lower graph shows that the maximum slope along the length of the curved chain ball lock segment is about 1.2mm/mm. In contrast, fig. 19B shows the radius (upper graph) and slope (lower graph) of the length of the tapered sequential locking segment along the curved chain. The maximum slope along the length of the curved chain tapered locking section is reduced to about 0.4mm/mm as compared to the maximum slope along the length of the curved chain spherical locking section. Thus, by reducing the maximum slope from about 1.2mm/mm to about 0.4mm/mm, the tapered locking segment may provide an improvement over the spherical locking segment.

Similarly, fig. 19C shows the radius (upper graph) and slope (lower graph) of the length of the hollow tapered sequential locking segment along the curved chain. The maximum slope of the length of the hollow tapered locking section along the curved chain is further reduced to about 0.17mm/mm compared to the maximum slope of the length of the spherical locking section along the curved chain and the length of the tapered locking section along the curved chain. Thus, the hollow tapered locking section may reduce the maximum slope to about 0.17mm/mm, which is lower than the spherical locking section and the tapered locking section. The hollow conical locking section also differs in that the hollow conical locking section may have a relatively reduced radius, which may reduce the force required to pull the chain-forming locking section into the buckle, especially in the event of an increase in tension when tightening the sling.

According to another embodiment of the present disclosure, the hollow conical locking section may comprise a notch. For example, as shown in fig. 20A and 20B, the hollow tapered locking section 2010 may include a notch 2020. The hollow tapered locking section 2010 may include a ball joint, such as ball joint 1440 of fig. 14. In some embodiments, as shown in fig. 20A and 20B, the notch 2020 may allow adjacent locking segments 2010 to be aligned with each other when the sling 2000 is bent to form a smooth surface with reduced or no protrusions along the inside of the sling 2000. Thus, when locking segments 2010 are aligned with each other through notch 2020, the radius from the centerline may be constant, with zero positive slope, thereby eliminating or reducing any protruding effect except for possible variations in force due to the angle between adjacent locking segments 2010.

In some embodiments, the hollow tapered locking segments may be strung on a belt, sling, wire, string, rope, cable, or the like, with a spacer between each locking segment. For example, as shown in FIG. 21, hollow tapered locking segments 2110 may be strung on a band 2100 with a spacer 2120 between each adjacent locking segment 2110. Similar to the hollow tapered locking section 2010 of fig. 20A and 20B, the hollow tapered locking section 2110 may include a notch 2130. The indentations 2130 may allow adjacent locking segments 2110 to align with one another when the sling 2100 is bent to form a smooth surface with no protrusions along the inside of the sling 2100. Thus, when the locking segments 2110 are aligned with one another through the notch 2130, the radius from the centerline may be constant, with zero positive slope, thereby eliminating or significantly reducing the protrusion effect, except for possible variations in force due to the angle between adjacent locking segments 2110.

According to another embodiment of the present disclosure, an improved method of visualizing an apparatus is disclosed. For example, the manipulation and actuation of an in vivo transcatheter device is typically guided by visualization using fluoroscopy. Thus, to facilitate visualization of the transcatheter device using fluoroscopy, radiopaque markers may be used. Radiopaque markers may appear with high contrast on fluoroscopic images and may be attached to the transcatheter device at strategic locations so that the location, orientation, and/or relative position of the transcatheter device can be clearly visualized.

In some embodiments, the radiopaque markers may be disposed at one or more locations on a component of the band, on the band, or on the band delivery device. Radiopaque markers may aid in the positioning and deployment of, for example, the transcatheter papillary muscle bands or ventricular bands. In some embodiments of the present disclosure, the radiopaque markers may aid in the positioning of the transcatheter tape by providing visual confirmation that the tape is properly positioned for deployment. For example, for a belt that includes a clasp (e.g., an actuatable clasp) at a first end thereof that locks in place along the belt to form a loop, it may be necessary to visually confirm that the second end of the belt has been inserted far enough into the clasp. Thus, accidental actuation of the buckle before the second end of the strap is fully inserted into the buckle can be avoided.

In another embodiment, the radiopaque marker may assist deployment of the transcatheter tape by providing a visual confirmation that actuation of the buckle has occurred. For example, for a strap that includes a buckle actuated by retraction of the buckle holder, visual confirmation may be required that the buckle holder has actually been retracted from the buckle in order to provide the user with confidence that the buckle has been actuated and locked in place.

In yet another embodiment of the present disclosure, the tape delivery device may include a radiopaque marker at its distal end. The radiopaque marker may be disposed adjacent to a clasp disposed in the band, and the band may include another radiopaque marker at its second end. Thus, this may provide confirmation that the second end of the strap is sufficiently inserted through the buckle so that the buckle may be actuated when the radiopaque marker on the second end of the strap passes the radiopaque marker on the distal end of the strap delivery device.

In some embodiments of the present disclosure, the tape delivery device may include a radiopaque marker at its distal end, a buckle adjacent the tape, and a tape insertion cable that may be attached to the second end of the tape may include a radiopaque marker near the location where the insertion cable is attached to the tape. Thus, when the radiopaque marker on the insertion cable passes over the radiopaque marker on the distal end of the delivery device, this provides confirmation that the second end of the strap is sufficiently inserted through the buckle so that the buckle can be actuated.

In some embodiments of the present disclosure, the delivery device may include a radiopaque marker on the buckle holder, and the band may include a radiopaque marker at its second end. Thus, this provides confirmation that the second end of the strap is sufficiently inserted through the buckle so that the buckle can be actuated when the radiopaque marker on the second end of the strap passes the radiopaque marker on the buckle holder.

In some embodiments of the present disclosure, the strap delivery device may include a radiopaque marker on the buckle holder, and the strap insertion cable, which may be attached to the second end of the strap, may include a radiopaque marker near the location where the insertion cable is attached to the strap. Thus, when the radiopaque marker on the insertion cable passes the radiopaque marker on the buckle holder, this provides confirmation that the second end of the strap is sufficiently inserted into the buckle so that the buckle can be actuated.

In some embodiments of the present disclosure, the tape delivery device can include a radiopaque marker on the buckle holder and a second radiopaque marker on the distal end of the delivery device. Additionally or alternatively, the radiopaque markers may be aligned such that when the holder is within the buckle, the radiopaque markers appear as a single marker (e.g., overlapping one another) in the fluoroscopic image. Furthermore, when the retainer is retracted from the buckle, the indicia appear as two separate indicia (e.g., no longer overlapping one another) in the fluoroscopic image. Additionally or alternatively, the radiopaque markers may be aligned such that when the retainer is within the buckle, the radiopaque markers appear in the fluoroscopic image as two separate markers in the fluoroscopic image, and when the retainer is retracted from the buckle, the markers overlap one another and appear as a single marker in the fluoroscopic image. In some embodiments, the radiopaque marker may comprise a cylindrical band.

22A-22D, for example, radiopaque markers may be provided on the delivery device, on the buckle holder, and on the strap to confirm buckle actuation. For example, as shown in fig. 22A, a radiopaque marker 2200a may be provided on the distal end 2210 of the delivery device 2220, a radiopaque marker 2200b may be provided on the clasp retainer 2230, and a radiopaque marker 2200c may be provided on the second end 2240 of the band 2250. In fig. 22A, the radiopaque markers 2200a and 2200b appear as a single band in the fluoroscopic image, indicating that the radiopaque markers 2200a and 2200b are aligned and overlap each other. In the fluoroscopic image of fig. 22A, the radiopaque marker 2200c on the second end 2240 of the band 2250 is located outside the distal end 2210 of the delivery device 2220, and therefore, the second end 2240 of the band 2250 has not yet passed through the buckle associated with the buckle holder 2230.

Referring now to fig. 22B, the radiopaque marker 2200c has passed through the radiopaque marker 2200a of the delivery device 2220 and is located inside the delivery device 2220. This indicates that the second end 2240 of the strap 2250 has been inserted through the clasp, and that the clasp may be actuated. Referring now to the fluoroscopic image of fig. 22C, the radiopaque markers 2200a and 2200b appear to be separate and no longer overlap each other. This confirms that the buckle associated with the buckle retainer 2230 has been actuated and thus locked to a portion of the strap 2250. As shown in fig. 22D, the radiopaque marker 2200c remains on the second end 2240 of the band 2250 even when the band insertion cable 2260 is separated from the band 2250.

Referring now to fig. 23A-23D, in some embodiments, radiopaque markers may be provided on the delivery device, on the buckle holder, and on the strap insertion cable to confirm buckle actuation. For example, as shown in fig. 23A, a radiopaque marker 2300a may be provided on the distal end 2310 of the delivery device 2320, a radiopaque marker 2300b may be provided on the clasp retainer 2330, and a radiopaque marker 2300c may be provided on the tape insertion cable 2340. In fig. 23A, the radiopaque markers 2300a and 2300b appear as a single band in the fluoroscopic image, indicating that the radiopaque markers 2300a and 2300b are aligned and overlap each other. In the fluoroscopic image of fig. 23A, the radiopaque marker 2300c on the strap insertion cable 2340 is positioned outside the distal end 2310 of the delivery device 2320, thereby indicating that one end of the strap 2350 attached to the strap insertion cable 2340 has not passed through the buckle associated with the buckle holder 2330.

Referring now to fig. 23B, the radiopaque marker 2300c has passed through the radiopaque marker 2300a of the delivery device 2320 and is located inside the delivery device 2320. This indicates that the end of the strap 2350 attached to the strap insertion cable 2340 has been inserted through the buckle, and that the buckle can be actuated. Referring now to the fluoroscopic image of fig. 23C, the radiopaque markers 2300a and 2300b appear to be separate and no longer overlap each other. This confirms that the buckle associated with buckle retainer 2330 has been actuated and thus locked to a portion of strap 2350. As shown in fig. 23D, the radiopaque marker 2300c is disengaged from the end of the band 2350, indicating that the band insertion cable 2340 has been disengaged from the end of the band 2350.

While the present disclosure is described herein with reference to illustrative embodiments of catheters, bands, and guidewires for particular applications, such as for papillary muscle repositioning and improving cardiac function, it should be understood that the embodiments described herein are not limited thereto. Those of ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, embodiments, and alternatives equivalent thereto, which are within the scope of the embodiments disclosed. Accordingly, the disclosed embodiments should not be considered limited by either the foregoing or the following description.

The many features and advantages of the present disclosure are apparent from the detailed specification and, thus, it is intended by the appended claims to cover all such features and advantages of the disclosure which fall within the true spirit and scope of the disclosure. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the disclosure to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the disclosure.

Moreover, those skilled in the art will appreciate that the conception upon which this disclosure is based may readily be utilized as a basis for the designing of other structures, methods and systems for carrying out the several purposes of the present disclosure. Accordingly, the claims are not to be regarded as limited by the foregoing description.

Claims

1. A cardiac device comprising:

a band configured to form a loop within the heart, wherein the band includes a first end and a second end;

A plurality of sequentially tapered locking segments located in a region of the belt proximate the second end, each locking segment comprising a raised region and an inclined region; and

An adjustable clasp at or near the first end, the adjustable clasp configured to form a fixed length loop by locking onto the raised area of the locking section after the second end has been inserted into the clasp,

Wherein adjacent locking segments are configured to bend relative to one another such that adjacent sloped regions can cooperate with one another to facilitate sliding of the locking segments into the buckle.

2. The apparatus of claim 1, wherein:

At least a portion of the band is a tube; and

The plurality of sequential locking segments are located within the tube.

3. The device of claim 1, wherein the adjacent locking segments are connected together by a mechanical joint configured to allow the locking segments to rotate relative to one another in at least one plane.

4. The device of claim 1, wherein the adjacent locking segments comprise beads strung on a flexible wire.

5. The device of claim 4, wherein the locking segments are separated by spacer beads.

6. The apparatus of claim 1, wherein the adjacent locking segments comprise hollow interiors such that the sloped region of each locking segment may be rotated relative to a centerline of the chain sequential locking segment to reduce the size of the protrusion between adjacent locking segments.

7. The device of claim 5, wherein at least a portion of each spacer bead is located within the hollow interior of the locking segment.

8. The apparatus of claim 1, wherein:

The plurality of sequential locking segments are integrally formed from a single piece,

The single piece includes an area connecting a plurality of sequential locking segments, an

The region is more flexible than the locking segment.

9. The device of claim 1, wherein the raised and sloped regions of the plurality of sequential locking segments slope and rise in only one plane such that the raised and sloped regions have at least one side that is smooth and free of protrusions.

10. The device of claim 2, wherein the strap is made of a material configured to allow the adjustable clasp to close on an outside surface of the tube and securely lock onto a raised area of a locking section inside the tube.

11. The device of claim 1, wherein the band comprises at least one of Polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), or dacron.

12. The apparatus of claim 1, wherein:

the plurality of sequential locking segments includes a first end and a second end, and

The second end of the strap is connected to the first ends of the plurality of sequential locking segments.

13. The apparatus of claim 12, wherein the second ends of the plurality of sequential locking segments are connected to locations along the belt.

14. A device according to claim 3, wherein:

The locking segment includes a notch, and

The indentations are configured such that when the belt is bent, adjacent locking segments are configured to align with one another such that there are no protrusions between adjacent locking segments, thereby providing a smooth surface along the inner surface of the belt.

15. The device of claim 5, wherein the locking segments and the spacer beads are configured such that when the band is bent, adjacent locking segments are configured to align with each other such that there are no protrusions between adjacent locking segments, thereby providing a smooth surface along the inner surface of the band.

16. The device of claim 8, wherein the region and the locking segments are configured such that when the band is bent, adjacent locking segments are configured to align with one another such that there are no protrusions between adjacent locking segments, thereby providing a smooth surface along the inner surface of the band.