Method and device for closing holes in tissue

• US 9,572,557 B2
• Filed: 10/15/2012
• Issued: 02/21/2017
• Est. Priority Date: 02/21/2006
• Status: Active Grant

• Current Assignee: Kardium Inc.
• Original Assignee: Kardium Inc.
• Inventors: Gelbart, Daniel, Lichtenstein, Samuel Victor
• Primary Examiner(s): Scherbel, Todd J
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US13/652,299
• Publication Number:
  US 20130041405A1
• Time in Patent Office: 1,590 Days
• Field of Search: 606/139, 606142-143, 606151-158, 606/213, 606/219
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00584 Clips
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/22061 for spreading elements apart

Abstract

A device for closing holes in tissue is delivered via a catheter to the inside of a body lumen such as a heart. An elastic barbed clip is expanded, pulled into the tissue and released, pulling the tissue with it. The operation is fully reversible.

Claims

1. A medical apparatus to close a hole in cardiac tissue, the medical apparatus comprising:

at least one tool; and

a closure device comprising;

a closed band,

a central passage open at opposed ends thereof to selectively removably receive a portion of the at least one tool therethrough, and

a plurality of barbs disposed radially about the central passage for attachment to the cardiac tissue,

wherein the closure device is resiliently biased from a first configuration in which a radial size of the central passage has a first dimension toward a second configuration in which the radial size of the central passage has a second dimension, the second dimension smaller than the first dimension, and a portion of the closure device forming at least part of a periphery of the central passage, the at least part of the periphery of the central passage located radially inward from the plurality of barbs at least in the second configuration, and

wherein the at least one tool includes a plurality of arms each with respective distal ends and proximate ends, the distal ends engaging the closed band of the closure device, the proximate ends pivotally coupled such that the distal ends are radially spaceable from one another between a retracted configuration and an expanded configuration to move the closure device from the second configuration to the first configuration.

2. The medical apparatus of claim 1, wherein the at least one tool cooperatively engages at least the part of the periphery of the central passage of the closure device to move the closure device between the second configuration and the first configuration.

3. The medical apparatus of claim 1 wherein the closure device is made of Nitinol.

4. The medical apparatus of claim 1 wherein the closure device comprises a plurality of lobes, a respective barb of the plurality of barbs extends from each lobe of the plurality of lobes.

5. The medical apparatus of claim 4 wherein the plurality of lobes surround the central passage.

6. The medical apparatus of claim 1 wherein, in each of the first configuration and the second configuration, each barb of the plurality of barbs extends generally parallel to a direction through the central passage along which the portion of the at least one tool is selectively removably receivable.

7. The medical apparatus of claim 1 wherein, in the first configuration, the closure device is in an expanded state and, in the second configuration, the closure device is in a relaxed state.

8. The medical apparatus of claim 7, wherein the at least one tool cooperatively engages at least the part of the periphery of the central passage of the closure device to move the closure device between the relaxed state and the expanded state.

9. The medical apparatus of claim 7 wherein, in at least the relaxed state, each barb of the plurality of barbs extends generally parallel to a direction through the central passage along which the portion of the at least one tool is selectively removably receivable.

10. The medical apparatus of claim 7 wherein each barb of the plurality of barbs is radially spaced outwardly from a longitudinal axis of the central passage by a respective first radial distance in the relaxed state and by a corresponding second radial distance in the expanded state, each first radial distance smaller than the corresponding second radial distance.

11. The medical apparatus of claim 7 wherein the at least part of the periphery of the central passage is located radially inward from the plurality of barbs by a first distance in the expanded state and by a second distance in the relaxed state, the first distance smaller than the second distance.

12. The medical apparatus of claim 1 wherein the at least part of the periphery of the central passage is located radially inward from the plurality of barbs by a first distance in the first configuration and by a second distance in the second configuration, the first distance smaller than the second distance.

13. The medical apparatus of claim 1 wherein, when mounted to the at least one tool for foreside implantation into the cardiac tissue, the barbs extend forwardly from a distal end of the at least one tool.

14. The medical apparatus of claim 1 wherein, when mounted to the at least one tool for blindside implantation into the cardiac tissue, the barbs extend rearwardly from a distal end of the at least one tool.

15. The medical apparatus of claim 1 wherein the closed band is made of Nitinol.

16. The medical apparatus of claim 1 wherein the closed band is tubular.

17. The medical apparatus of claim 16 wherein the closed band is multi-lobed.

18. The medical apparatus of claim 17 wherein each of the plurality of barbs are located at respective ones of the lobes.

19. The medical apparatus of claim 1, wherein the plurality of arms includes four arms, the distal ends of which are configured to engage the closed band of the closure device during implantation of the closure device.

20. The medical apparatus of claim 1 wherein the at least one tool includes a taper element mounted for translation along at least one catheter, and which physically engages the arms of the at least one tool to cause the arms to pivot between the retracted and the expanded configurations.

21. The medical apparatus of claim 20 wherein the taper element is at a distal end of a rod slideably received through a passage in a tube to which the arms are pivotally coupled, the tube received in a lumen of the at least one catheter.

22. The medical apparatus of claim 21 wherein the taper element engages the arms to pivotally expand the arms as the taper element moves away from the distal end with respect to the tube.

23. The medical apparatus of claim 20 wherein the taper element is at a distal end of a rod, the rod including a longitudinal passage that slideably receives the at least one catheter, the rod slideably received through a passage in a tube to which the arms are pivotally coupled.

24. The medical apparatus of claim 23 wherein the taper element engages the arms to pivotally expand the arms as the tube moves with respect to the rod.

25. The medical apparatus of claim 1, wherein the at least one tool cooperatively engages the closure device to move the closure device between a relaxed state and an expanded state.

26. The medical apparatus of claim 1 wherein the closed band comprises a laser cut structure.

27. The medical apparatus of claim 1

wherein, in the first configuration, tissue-penetrating-tips of the plurality of barbs are positioned to be arranged about the cardiac tissue that encompasses the hole just prior to embedding the tissue-penetrating-tips into the cardiac tissue, and

wherein the distal ends engage the closed band in an arrangement that avoids any contact with the tissue-penetrating tips of the plurality of barbs during a movement between the second configuration and the first configuration.

28. The medical apparatus of claim 1

wherein, in the first configuration, tissue-penetrating-tips of the plurality of barbs are positioned to be arranged about the cardiac tissue that encompasses the hole just prior to embedding the tissue-penetrating-tips into the cardiac tissue, and

wherein the distal ends engage the closed band in an arrangement that avoids any contact with the tissue-penetrating tips of the plurality of barbs during a movement of the portion of the at least one tool through the central passage in the second configuration.

29. The medical apparatus of claim 1 wherein the portion of the at least one tool, which is selectively removably receivable through the central passage, comprises a tissue-penetrating portion.

30. The medical apparatus of claim 29 wherein the portion of the at least one tool and the closure device are configured to close the hole in the cardiac tissue around the tissue penetrating portion while the tissue-penetrating portion is in a position configured to penetrate the cardiac tissue and while the at least one tool causes the peripheral portion to move between the second configuration and the first configuration.

31. The medical apparatus of claim 1 wherein the at least part of the periphery of the central passage is located radially inward from the plurality of barbs in the first configuration.

32. A medical apparatus to close a hole in cardiac tissue, the medical apparatus comprising:

at least one tool; and

a closure device comprising;

a central passage open at opposed ends thereof to selectively removably receive a portion of the at least one tool therethrough, and

a plurality of barbs disposed radially about the central passage for attachment to the cardiac tissue,

wherein the closure device is resiliently biased from a first configuration in which a radial size of the central passage has a first dimension toward a second configuration in which the radial size of the central passage has a second dimension, the second dimension smaller than the first dimension, and a portion of the closure device forming at least part of a periphery of the central passage, the at least part of the periphery of the central passage located radially inward from the plurality of barbs at least in the second configuration,

wherein the closure device comprises a plurality of lobes, a respective barb of the plurality of barbs extending from each lobe, and

wherein the at least one tool includes a plurality of arms each with respective distal ends and proximate ends, each of the distal ends respectively engaging one of the plurality of lobes, the proximate ends pivotally coupled such that the distal ends are radially spaceable from one another between a retracted configuration and an expanded configuration to move the closure device from the second configuration to the first configuration.

33. A medical apparatus to close holes in a cardiac tissue, comprising:

a closure device comprising a lobed band with a central passage open at opposed ends thereof, and a plurality of barbs disposed radially about the central passage and extending generally longitudinally from the lobed band for selective attachment to the cardiac tissue, the closure device resiliently biased from a first configuration in which a radial size of the central passage has a first dimension toward a second configuration in which the radial size of the central passage has a second dimension, the second dimension smaller than the first dimension; and

a tool having a plurality of arms each with respective distal ends and proximate ends, at least a portion of the arms are selectively removably receivable together through the central passage of the lobed band at least during implantation of the closure device, the proximate ends of the arms pivotally coupled such that the distal ends are radially spaceable from one another between a retracted configuration and an expanded configuration to move the closure device from the second configuration to the first configuration.

34. The medical apparatus of claim 33, further comprising:

a tube having a longitudinal passage, the arms pivotally coupled to the tube at the proximate ends thereof; and

a rod translatable to selectively engage the arms with a tapered element.

35. The medical apparatus of claim 33 wherein the rod is translatably received in the longitudinal passage of the tube.

36. The medical apparatus of claim 35 wherein the tube is receivable through a lumen of a catheter.

37. The medical apparatus of claim 35 wherein the rod has a passage sized to slideably receive a catheter.

38. The medical apparatus of claim 33 wherein the lobed band comprises a laser cut metal structure.