Apical closure system

Abstract

Aspects of the present invention provide apparatuses and methods for closing an apical hole in a heart of a subject, including a hole-closure device that includes a tissue-attachment portion configured to attach to cardiac tissue around the apical hole, and a collapsible portion coupled to the tissue-attachment portion and configured to close the hole by collapsing inwardly inside the apical hole.

Claims

1. An apparatus for closing a hole in tissue comprising: a tissue-attachment portion configured to attach to tissue around a hole, wherein the tissue-attachment portion comprises one or more hooks, barbs, pins, adhesive portions, screws, staples or other elements that are configured to become attached to tissue; a ring-shaped collapsible portion coupled to the tissue-attachment portion and being at least partially formed from a shape-memory material to be configured to close the hole by collapsing inwardly to assume a collapsed state from an expanded state; and a sealing material disposed within an interior of the collapsible portion and configured to seal a center of the collapsible portion when the collapsible portion is in the collapsed state, wherein collapse of the collapsible portion causes collapse of the tissue attachment portion, and wherein collapse of the tissue-attachment portion is configured to draw tissue together and in conjunction with the sealing material disposed within the interior of the collapsible portion is configured to close the hole.

2. The apparatus of claim 1, wherein the tissue-attachment portion comprises a plurality of hooks of a shape-memory alloy that are configured to assume a U-shape when the tissue-attachment portion is not constrained.

3. An apparatus for closing a hole in tissue comprising: a tissue-attachment portion configured to attach to tissue around a hole; a ring-shaped collapsible portion coupled to the tissue-attachment portion and being at least partially formed from a shape-memory material to be configured to close the hole by collapsing inwardly to assume a collapsed state from an expanded state; and a sealing material disposed within an interior of the collapsible portion and configured to seal a center of the collapsible portion when the collapsible portion is in the collapsed state, wherein collapse of the collapsible portion causes collapse of the tissue attachment portion, and wherein collapse of the tissue-attachment portion is configured to draw tissue together and in conjunction with the sealing material disposed within the interior of the collapsible portion is configured to close the hole, wherein the tissue-attachment portion comprises: a first tissue-attachment portion configured to couple to tissue around a first side of the hole; and a second tissue-attachment portion configured to couple to tissue around a second side of the hole.

4. A system for closing a hole in tissue comprising: a hole-closure device comprising: a tissue-attachment portion configured to attach to tissue around a hole; and a collapsible portion coupled to the tissue-attachment portion and configured to close the hole by collapsing inwardly, the collapsible portion having an expanded configuration and a collapsed configuration; wherein collapse of the collapsible portion from the expanded configuration to the collapsed configuration causes collapse of the tissue-attachment portion; wherein collapse of the tissue-attachment portion draws the tissue together to close the hole; and a delivery device comprising: a shaft configured to maintain the collapsible portion of the hole-closure device in the expanded configuration by extending therethrough, wherein the hole-closure device is in a delivery configuration when mounted on the shaft with the collapsible portion in the expanded configuration; and a sheath that covers the hole-closure device in the delivery configuration, wherein the sheath is slidable relative to the delivery device and is configured to be removably disposed around the tissue-attachment portion to maintain the tissue-attachment portion in a non-attachment configuration, when the hole-closure device is in the delivery configuration; wherein upon withdrawal of the sheath from around the tissue-attachment portion, the tissue-attachment portion returns to an attachment configuration; and wherein upon withdrawal of the shaft from within the collapsible portion, the collapsible portion inwardly collapses from the expanded configuration to the collapsed configuration.

5. The system of claim 4, wherein the delivery device is configured to be used for a transapical procedure conducted via an apical hole, while the hole-closure device is in the delivery configuration and disposed around the delivery device shaft.

6. The system of claim 5, wherein the delivery device comprises a lumen configured to allow passage therethrough of an instrument for use in the transapical procedure.

7. The system of claim 4, wherein the delivery device comprises a lumen configured to allow passage therethrough of an instrument for use in a medical procedure.

8. The system of claim 4, wherein the collapsible portion comprises a sealing material disposed in an interior thereof.

9. The system of claim 4, wherein the tissue-attachment portion is in a straightened state when in the non-attachment configuration, and wherein the tissue-attachment portion defines a U-shape when in the attachment configuration.

10. The system of claim 4, wherein the tissue-attachment portion comprises a shape-memory alloy.

11. The system of claim 4, wherein the tissue-attachment portion comprises a plurality of tissue-attachment elements.

12. The system of claim 4, wherein the tissue-attachment portion comprises a plurality of hooks configured to hook to tissue.

13. The system of claim 4, wherein the tissue-attachment portion comprises: a first tissue-attachment portion configured to couple to tissue around a first side of the hole; and a second tissue-attachment portion configured to couple to tissue around a second side of the hole.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a schematic illustration of an apical-hole closure device, in accordance with some exemplary embodiments of the present invention.

(2) FIG. 2 is a schematic illustration of the apical-hole closure device disposed around a delivery device, in accordance with some exemplary embodiments of the present invention.

(3) FIG. 3 is a schematic illustration of the delivery device being advanced toward the apex of the heart, in accordance with some exemplary embodiments of the present invention.

(4) FIG. 4 is a schematic illustration of the delivery device inserted inside an apical hole, the apical-hole closure device being disposed around the delivery device, in accordance with some exemplary embodiments of the present invention.

(5) FIG. 5 is a schematic illustration of a sheath being withdrawn from around the distal end of the apical-hole closure device, in accordance with some exemplary embodiments of the present invention.

(6) FIG. 6 is a schematic illustration of distal tissue-attachment elements of the apical-hole closure device becoming attached to cardiac tissue around the intracardiac end of the apical hole, in accordance with some exemplary embodiments of the present invention.

(7) FIG. 7 is a schematic illustration of proximal tissue-attachment elements of the apical-hole closure device becoming attached to cardiac tissue around the extracardiac end of the apical hole, in accordance with some exemplary embodiments of the present invention.

(8) FIG. 8 is a schematic illustration of the insertion device being withdrawn from the apical hole subsequent to the tissue-attachment elements becoming attached to the cardiac tissue, in accordance with some exemplary embodiments of the present invention.

(9) FIG. 9 is a schematic illustration of the apical-hole closure device in a collapsed state thereof, subsequent to the withdrawal of the insertion device from the apical hole, in accordance with some exemplary embodiments of the present invention.

(10) FIG. 10A is a schematic illustration of the apical-hole closure device on a delivery device while a sheath is disposed around the apical-hole closure device, in accordance with some exemplary embodiments of the present invention.

(11) FIG. 10B is a schematic illustration of the apical-hole closure device on a delivery device subsequent to the sheath having been withdrawn from around the apical-hole closure device.

(12) FIG. 10C is an enlarged cross-sectional schematic illustration of a portion of the schematic illustration of FIG. 10B.

(13) FIG. 11 is a schematic illustration of an apical-closure device that includes a flexible material in a central portion thereof, in accordance with some exemplary embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

(14) Reference is now made to FIG. 1, which is a schematic illustration of an apical-hole closure device 20, in accordance with some exemplary embodiments of the present invention. The apical-hole closure device is typically used to close an artificial hole in the apex of a subject's heart due to a transapical procedure, such as an aortic valve implantation procedure, a left ventricular bypass procedure, an aortic cannulation procedure, and/or a different transapical procedure.

(15) Apical-hole closure device 20 includes at least one tissue-attachment portion 22. For example, as shown in FIG. 1, apical-hole closure device 20 may include distal and proximal tissue-attachment portions 22 disposed respectively at distal end 24 and proximal end 26 of device 20. For some exemplary embodiments, as shown, tissue-attachment portion 22 includes a plurality of tissue-attachment elements 28, such as hooks, pins, adhesive portions, and/or other elements that are configured to become attached to tissue of the subject around the apical hole.

(16) Apical-hole closure device 20 additionally includes a collapsible portion 32 that is coupled to tissue-attachment portion 22, and that has expanded and contracted states thereof, as described in further detail herein. For some exemplary embodiments, collapsible portion 32 includes collapsible members 34 that couple tissue-attachment elements 28 to each other, as shown. For example, collapsible members 34 may have a saw-tooth shape (as shown), or a sinusoidal shape (not shown), and/or another shape that facilitates the collapse of the collapsible portion from an expanded state to a collapsed state thereof.

(17) Typically, collapsible portion 32 includes a shape-memory material (e.g., nitinol). For some applications, the shape-memory material is shaped such that when unconstrained, it assumes the shape that it has in the collapsed state. During insertion of apical-hole closure device 20 into the apical hole, collapsible portion 32 is stretched by a delivery device 40, as described herein. When delivery device 40 is withdrawn from apical-hole closure device 20 (i.e., removed from inside collapsible portion 32), collapsible portion 32 recollapses into the collapsed state. Alternatively, the shape-memory material is configured such that collapsible portion 32 is in the expanded state at a temperature which is not 37 C. Shape-memory techniques are used to configure collapsible portion 32 to change to the collapsed state, when collapsible portion 32 is allowed to reach 37 C, when it is disposed inside the apical hole.

(18) For some exemplary embodiments, a sealing material 36 is disposed inside collapsible portion 32. For example, sealing material 36 may include a supple biocompatible material (such as woven or knitted polyester, biological tissue (e.g., tissue of the pericardium), or expanded polytetrafluoroethylene (ePTFE)). The material is typically folded inside collapsible portion 32, such that when collapsible portion 32 is in the collapsed state thereof, the sealing material seals the inside of apical-hole closure device 20, as described herein.

(19) Reference is now made to FIG. 2, which is a schematic illustration of apical-hole closure device 20 disposed around delivery device 40, in accordance with some exemplary embodiments of the present invention. In accordance with respective exemplary embodiments, delivery device 40 is a dedicated delivery device for delivering apical-hole closure device 20 to the apical hole, or is a device that is additionally used for a part of the transapical procedure other than the delivery of apical-hole closure device 20. For example, delivery device 40 may be a catheter by means of which tools are inserted into the subject's heart during a transapical procedure. For some exemplary embodiments, delivery device 40 is used to insert apical-hole closure device 20 into the apical hole prior to or subsequent to the transapical procedure.

(20) A sheath 42 is typically disposed around apical-hole closure device 20 during insertion of apical-hole closure device 20 into the apical hole. Sheath 42 constrains tissue-attachment elements 28 of apical-hole closure device 20 during insertion of apical-hole closure device 20 into the hole.

(21) Reference is now made to FIG. 3, which is a schematic illustration of delivery device 40 being advanced toward a hole 50 at apex 52 of a heart 54, in accordance with some exemplary embodiments of the present invention. For some exemplary embodiments, distal end 56 of delivery device 40 is used to incise the subject's heart 54 and to create hole 50 in apex 52 of heart 54. Alternatively or additionally, a cutting tool is inserted via delivery device 40 in order to incise apex 52 of heart 54, and the distal end of delivery device 40 dilates hole 50. Further alternatively or additionally, delivery device 40 is inserted into hole 50 subsequent to apex 52 having been incised during a transapical procedure.

(22) Reference is now made to FIG. 4, which is a schematic illustration of delivery device 40 inserted within apical hole 50, with apical-hole closure device 20 disposed around delivery device 40, in accordance with some exemplary embodiments of the present invention. As can be seen, the apical-hole closure device 20 is preferably positioned such that tissue-attachment elements 28 are aligned with a proximal and a distal side of apical hole 50. It is understood that although tissue-attachment elements 28 are shown as tines, in some embodiments other types of tissue-attachment elements are alternatively or additionally used, including, for example, adhesive, sutures, screws, pins, or staples.

(23) Reference is now made to FIGS. 5 and 6, which are schematic illustrations of sheath 42 being withdrawn from around distal end 24 of apical-hole closure device 20, in accordance with some exemplary embodiments of the present invention. For some exemplary embodiments, once apical-hole closure device 20 is positioned inside apical hole 50, sheath 42 is withdrawn from around distal end 24 of apical-hole closure device 20, in the direction of arrow 60. In response to sheath 42 being withdrawn, tissue-attachment portion 22 at distal end 24 of apical-hole closure device 20 becomes attached to cardiac tissue around apical hole 50. For example, tissue-attachment elements 28 of tissue-attachment portion 22 may include a shape-memory alloy (such as nitinol). While tissue-attachment elements 28 are inside sheath 42, sheath 42 constrains tissue-attachment elements 28 in a non-attachment configuration (e.g., straightened). In response to sheath 42 being withdrawn from around tissue-attachment elements 28, tissue-attachment elements 28 curve in an attachment configuration (e.g., defining a U-shape) and become attached to tissue around apical hole 50. Although the illustrated embodiment contains six tissue-attachment elements 28, it is understood that greater than six or less than six tissue-attachment elements 28 can be used.

(24) In regard to an embodiment using, for example, adhesive as tissue-attachment elements 28, the withdrawal of sheath 42 from around tissue attachment elements 28 can expose the adhesive to tissue around apical hole 50, thereby causing apical-hole closure device 20 to become attached to tissue around apical hole 50.

(25) In regard to an embodiment using, for example, pins or staples as tissue-attachment elements 28, tissue-attachment elements 28 can be constrained in a non-attachment configuration by sheath 42, and the withdrawal of sheath 42 from around tissue attachment elements 28 can allow tissue-attachment elements 28 to naturally move to a non-constrained state, which coincides with an attachment configuration. This movement can cause tissue-attachment elements 28 to attach to tissue around apical hole 50 (e.g., pins or staple tines can extend into and affix to the tissue), thereby causing apical-hole closure device 20 to become attached to tissue around apical hole 50.

(26) Reference is now made to FIG. 7, which is a schematic illustration of sheath 42 having been withdrawn from around proximal end 26 of apical-hole closure device 20, in accordance with some exemplary embodiments of the present invention. For some exemplary embodiments, subsequent to the withdrawal of sheath 42 from distal end 24 of apical-hole closure device 20, sheath 42 is withdrawn from proximal end 26 of device 20, in the direction of arrow 60. In response to sheath 42 being withdrawn, tissue-attachment portion 22 at proximal end 26 of apical-hole closure device 20 becomes attached to cardiac tissue around apical hole 50. For example, tissue-attachment elements 28 at proximal end 26 of apical-hole closure device 20 may function in a similar manner to tissue-attachment elements 28 at distal end 24 of apical-hole closure device 20, as described with reference to FIGS. 5-6. Although the illustrated embodiment includes hooks at both distal end 24 and proximal end 26 of apical-hole closure device 20, it is understood that tissue-attachment elements 28 on the proximal end may be of a different type different from tissue attachment elements 28 on the distal end, and that more than one type of tissue-attachment element 28 may be on the same end.

(27) As shown, for some exemplary embodiments, apical-hole closure device 20 includes tissue-attachment portions 22 at distal end 24 and at proximal end 26 of apical-hole closure device 20. Apical-hole closure device 20 is shaped such that when sheath 42 is withdrawn from apical-hole closure device 20, distal tissue-attachment portion 22 becomes attached to intracardiac tissue around apical hole 50, and the proximal tissue-attachment portion 22 becomes attached to extracardiac tissue around apical hole 50. Alternatively, apical-hole closure device 20 is shaped such that one or both of the tissue-attachment portions 22 become attached to a different portion of the subject's tissue. For example, apical-hole closure device 20 may be shaped such that one or both of the tissue-attachment portions 22 becomes attached to tissue of the myocardium that surrounds a central portion of hole 50 (i.e., a portion of hole 50 that is not at the intracardiac or the extracardiac end of hole 50). Further alternatively, apical-hole closure device 20 includes only one tissue-attachment portion 22, disposed at proximal end 26 or distal end 24 of apical-hole closure device 20, or in a different region of apical-hole closure device 20. For example, apical-hole closure device 20 may include a single tissue-attachment portion 22, disposed along part or the entire length of device 20 (e.g., an adhesive surrounded by a sheath, or a plurality of mechanical tissue-engagement elements as described herein (for example, hooks or barbs)). Still further alternatively, apical-hole closure device 20 includes more than two tissue-attachment portions 22.

(28) Reference is now made to FIG. 8, which is a schematic illustration of insertion device 40 being withdrawn from apical hole 50 subsequent to tissue-attachment portions 22 becoming attached to cardiac tissue, in accordance with some exemplary embodiments of the present invention. Typically, as insertion device 40 is withdrawn from the distal end of apical hole 50, in the direction of arrow 70, collapsible portion 32 at distal end 24 of apical-hole closure device 20 collapses. As insertion device 40 continues to be withdrawn in the direction of arrow 70, collapsible portion 32 at proximal end 26 of apical-hole closure device 20 collapses (FIG. 9). Since tissue-attachment portions 22 of the apical-hole closure device are attached to tissue around hole 50, the collapse of collapsible portion 32 results in the tissue that surrounds hole 50 being pulled toward the center of hole 50, thereby at least partially closing hole 50.

(29) Reference is now made to FIG. 9, which is a schematic illustration of apical-hole closure device 20 in a collapsed state thereof, subsequent to the withdrawal of insertion device 40, in accordance with some exemplary embodiments of the present invention. Collapsible portion 32 typically causes apical-hole closure device 20 to collapse toward the center of apical hole 50. Since apical-hole closure device 20 is attached to myocardial tissue via tissue-attachment elements 28, the collapse of apical-hole closure device 20 pulls the myocardial tissue around hole 50 toward the center of hole 50. For some exemplary embodiments, the myocardial tissue naturally contracts toward the center of hole 50 following removal of insertion device 40 from hole 50, and apical-hole closure device 20 assists the natural process.

(30) Typically, sealing material 36 is disposed in the center of apical-hole closure device 20, and seals apical hole 50 due to the collapse of apical-hole closure device 20. For some exemplary embodiments, a different element is used to seal the center of device 20. For example, a valve may be disposed in the center of device 20, the valve being configured to close upon the removal of insertion device 40 from inside apical-hole closure device 20. Sealing material 36 typically seals apical-hole closure device 20, thereby sealing apical hole 50.

(31) Reference is now made to FIG. 10A, which is a schematic illustration of apical-hole closure device 20 on delivery device 40 while sheath 42 is disposed around apical closure device 20, FIG. 10B, which is a schematic illustration of apical-hole closure device 20 on delivery device 40 subsequent to sheath 42 having been withdrawn from around apical-hole closure device 20, and FIG. 10C, which is an enlarged cross-sectional schematic illustration of a portion of the schematic illustration of FIG. 10B. FIG. 10B shows tissue-attachment portion 22 having become attached to the myocardial tissue of heart 54 around hole 50 in the tissue, due to the removal of sheath 42 from around apical-hole closure device 20. It is noted that, for illustrative purposes, FIG. 10B does not show certain portions of apical-hole closure device 20, such as collapsible portion 32.

(32) Reference is now made to FIG. 11, which is a schematic illustration of apical-hole closure device 20, including a flexible central portion 80, made of flexible material, in accordance with some exemplary embodiments of the present invention. For some exemplary embodiments, there are proximal and distal collapsible portions 32 toward the distal and proximal ends 24 and 26 of apical-hole closure device 20. Proximal and distal collapsible portions 32 facilitate closure of the extracardiac and intracardiac ends of apical hole 50, in accordance with the techniques described herein. In between proximal and distal collapsible portions 32, there is flexible central portion 80, and there is no collapsible portion disposed around flexible central portion 80. Flexible central portion 80 seals the central region of apical hole 50 (i.e., the region of apical hole 50 that is between extracardiac and intracardiac ends of hole 50), even in the absence of a collapsible portion at the central region, due to contraction of the cardiac tissue at the central region of hole 50, around flexible central portion 80. For some exemplary embodiments, flexible central portion 80 is the same material as (and is optionally coupled to) sealing material 36. Alternatively, flexible central portion 80 is different from sealing material 36 (as shown). For example, flexible central portion 80 may be a supple biocompatible material (such as woven or knitted polyester, biological tissue (e.g., tissue of the pericardium), or ePTFE)

(33) Although exemplary embodiments have been described herein for closing a hole in the apex of a subject's heart, the scope of the present invention includes the application of the apparatus and methods described herein to close any hole in a subject's body. For example, the hole-closure device described herein may be used to close holes resulting from other types of surgery, and/or bullet holes.

(34) For some applications, techniques and apparatus described in the present patent application are combined with techniques and apparatus described in U.S. patent application Ser. No. 12/750,829, filed Mar. 21, 2010 to Rothstein et al., entitled Auto-Closure Apical Access Positioner Device and Method, which is incorporated herein in its entirety by reference thereto.

(35) It is noted that in transapical procedures, a hole is typically made at an apical site that is superior and lateral to the lowest point of the subject's heart (i.e., the anatomical apex of the heart). Therefore, the apical-hole closure device described herein is typically used to close apical holes that are in the vicinity of the anatomical apex of the heart, but not necessarily at the anatomical apex of the heart. Nevertheless, the scope of the present invention includes using the apical closure device to close an apical hole that is located at the anatomical apex of the heart. The term apical hole as used in the present application should be interpreted as including holes at the anatomical apex of the heart, as well as holes that are in the vicinity of the anatomical apex of the heart, but not necessarily at the anatomical apex of the heart.

(36) It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described herein. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described herein, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.