Closing openings in anatomical tissue

• US 9,050,066 B2
• Filed: 05/20/2011
• Issued: 06/09/2015
• Est. Priority Date: 06/07/2010
• Status: Active Grant

• Current Assignee: Kardium Inc.
• Original Assignee: Kardium Inc.
• Inventors: Lichtenstein, Samuel
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US13/112,695
• Publication Number:
  US 20110301618A1
• Time in Patent Office: 1,481 Days
• Field of Search: 606/151, 606/213, 606/139, 606/219, 606/153, 606/158, 606/142, 227/175.1
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft
• CPC Class Codes: A61B 2090/08021 of the patient or his organs

Abstract

A device for closing at least one opening leading to an anatomical cavity is delivered via a catheter positioned in a first opening leading to the anatomical cavity. An orientation control unit, positioned within the anatomical cavity, an orientation of a portion of a tissue surface within the anatomical cavity that is skewed with respect to the first opening and orients a closure member of the device with the tissue surface. An occluding member and a constricting unit are positioned within the anatomical cavity, the occluding member blocking a portion of an opening that is constricted by the constricting unit. An intermediate member of the device is positioned within the anatomical cavity and a closure unit employing at least one piercing element pierces through the intermediate member into a tissue wall surrounding the anatomical cavity.

Claims

1. A medical system to perform a procedure on a tissue wall, at least a portion of the tissue wall forming an anatomical cavity, an opening in the tissue wall leading to the anatomical cavity from a foreside of the tissue wall to a blind side of the tissue wall opposed across a thickness of the tissue wall from the foreside thereof, the opening extending along a path having a direction having a skewed angle relative to a portion of an interior surface of the tissue wall on the blind side of the tissue wall, and the medical system comprising:

a closure unit arranged to constrict at least a portion of the opening from the blind side of the tissue wall;

an elongated member comprising a proximal portion and a distal portion, the distal portion at which the closure unit is detachably removably coupled, the elongated member arranged to deliver at least a portion thereof through the opening in the tissue wall from the foreside thereof distal portion first into the anatomical cavity, and to cause penetration of the tissue wall from the blind side thereof by the closure unit from an interior of the anatomical cavity, the elongated member further comprising an articulation portion arranged to provide articulated movement between the proximal portion of the elongated member and the closure unit; and

an orientation control unit coupled to the articulation portion to cause the articulation portion to change an angle between the closure unit and a portion of the elongated member via the articulated movement to accommodate the skewed angle and align the closure unit with the portion of the interior surface of the tissue wall on the blind side of the tissue wall,

wherein at least a portion of the orientation control unit is positionable within the anatomical cavity to block the opening, constricted by the closure unit, in the tissue wall on the blind side of the tissue wall.

2. The medical system of claim 1 wherein the portion of the orientation control unit extends radially outwardly from a tube through which a portion of the medical system, including the portion of the orientation control unit, passes and aligns the closure unit within the anatomical cavity to reduce an angular deviation of the closure unit from an axis positioned normal to a point on the portion of the interior tissue surface within the anatomical cavity.

3. The medical system of claim 1 wherein the orientation control unit comprises a member having a contact surface arranged to contact the interior tissue surface surrounding the opening on the blind side of the tissue wall within the anatomical cavity, an orientation of the portion of the interior tissue surface within the anatomical cavity defined by the orientation control unit based at least on the contact established between the contact surface of the member and the interior tissue surface on the blind side of the tissue wall within the anatomical cavity.

4. The medical system of claim 3 wherein the contact surface of the member is selectively moveable between a retracted position when the orientation control unit is delivered though the opening in the tissue wall and an extended position when the contact surface of the member is positioned to directly contact the interior tissue surface that surrounds the opening in the tissue wall on the blind side of the tissue wall within the anatomical cavity.

5. The medical system of claim 4 wherein the member of the orientation control unit includes an inflatable member including the contact surface, the inflatable member further comprising a fluid source in fluid communication with the orientation control unit, the fluid source being selectively controllable to move the contact surface of the inflatable member between the retracted position and the extended position.

6. The medical system of claim 3 wherein the member of the orientation control unit comprises an inflatable member sized and positioned between the elongated member and the closure unit to be completely received in the anatomical cavity when the closure unit is positioned to cause penetration of the tissue wall from the blind side thereof.

7. The medical system of claim 3 wherein the member having the contact surface is an inflatable member.

8. The medical system of claim 3 wherein the contact surface of the member is selectively moveable between a retracted position when the orientation control unit is delivered though the opening in the tissue wall and an extended position when the contact surface of the member is positioned to directly contact the interior tissue surface that surrounds the opening in the tissue wall on the blind side within the anatomical cavity.

9. The medical system of claim 3 wherein the member of the orientation control unit includes a pad which overlaps the opening in the tissue wall from the blind side thereof and contacts the tissue wall surrounding the opening in the tissue wall on the blind side to occlude the opening.

10. The medical system of claim 1 wherein the closure unit comprises a plurality of tissue piercing elements arranged to piercingly engage the tissue wall from the blind side thereof from the interior of the anatomical cavity when the closure unit is positioned in the anatomical cavity, a distal most portion of the closure unit positioned to precede the portion of the orientation control unit through the hole and into the anatomical cavity.

11. The medical system of claim 10 wherein each tissue piercing element of at least some of the tissue piercing has a respective tip and is arranged to pierce the tissue wall tip first, each tip pointed rearwardly with respect to a direction of travel as the closure unit is delivered through the opening in the tissue wall from the foreside of the tissue wall to the blind side of the tissue wall.

12. The medical system of claim 10 wherein the medical system comprises an actuator operable to expand the plurality of tissue piercing elements to surround the opening at least when the closure unit is positioned in the anatomical cavity.

13. The medical system of claim 1 wherein the articulation portion of the elongated member forms at least part of a passive self-aligning mechanism that in use aligns the closure unit with the portion of the interior surface of the tissue wall within the anatomical cavity.

14. The medical system of claim 1 wherein the closure unit is arranged at the distal portion of the elongated member to piercingly engage the tissue wall from the blind side thereof from the interior of the anatomical cavity as the elongated member is drawn proximally.

15. The medical system of claim 1 wherein the orientation control unit aligns the closure unit within the anatomical cavity to reduce an angular deviation of the closure unit from an axis positioned normal to a surface of the blind side of the tissue wall.

16. The medical system of claim 1 wherein the orientation control unit aligns the closure unit within the anatomical cavity to reduce an angular deviation between (a) a direction of travel of the closure unit through the opening in the tissue wall from the foreside of the tissue wall to the blind side of the tissue wall and (b) a direction that an axis positioned normal to a surface of the blind side of the tissue wall extends along.

17. The medical system of claim 1 wherein the orientation control unit comprises a member having a contact surface, the orientation of the portion of the interior tissue surface within the anatomical cavity defined by the orientation control unit based at least on contact established between the contact surface and a surface of the blind side of the tissue wall.

18. The medical system of claim 1 wherein the portion of the orientation control unit comprises a member selectively moveable between a retracted position in which the member is shaped for delivery through the opening in the tissue wall and an extended position in which the member is shaped to surround the opening in the tissue wall at least when the portion of the orientation control unit is positioned within the anatomical cavity.

19. The medical system of claim 1 wherein the elongated member further comprises an elongated rod member extending toward the closure unit, and wherein the articulation portion comprises a hinge that pivotally couples the closure unit to the rod member.

20. The medical system of claim 1 wherein the elongated member further comprises an elongated rod member extending toward the closure unit, and wherein the articulation portion pivotally couples the closure unit to the rod member, the articulation portion arranged such that the articulation portion is located in (a) the opening in the tissue wall, (b) the anatomical cavity, or both (a) the opening in the tissue wall and (b) the anatomical cavity when the closure unit is located in the anatomical cavity.

21. The medical system of claim 1 wherein the anatomical cavity is a naturally occurring anatomical cavity, and wherein the opening in the tissue wall is formed by a perforation in the tissue wall.

22. The medical system of claim 1 wherein the at least a portion of the orientation control unit comprises an inflatable member detachably removably coupled, along with the closure unit, at the distal portion of the elongated member, the inflatable member positionable within the anatomical cavity to block, when detached from the distal portion of the elongated member, the opening, constricted by the closure unit, in the tissue wall on the blind side of the tissue wall.

23. A medical system to perform a procedure on a tissue wall, at least a portion of the tissue wall forming an anatomical cavity having an interior tissue surface interrupted by one or more openings, at least a first opening in the tissue wall providing a passage through the tissue wall leading to the anatomical cavity from a foreside of the tissue wall to a blind side of the tissue wall opposed across a thickness of the tissue wall from the foreside thereof, the medical system comprising:

an elongated member;

a constricting unit detachably removably coupled to the elongated member and comprising a plurality of tissue piercing elements, the constricting unit arranged to be delivered through one of the one or more openings into the anatomical cavity to a location proximate the first opening in the tissue wall where the constricting unit is manipulable to constrict at least a portion of the first opening, the tissue piercing elements piercing the tissue wall from the blind side thereof during the constricting of the at least a portion of the first opening; and

an occluding member detachably removably coupled to the elongated member and moveable between a retracted configuration and an extended configuration, the occluding member shaped in the retracted configuration to be delivered through the first opening in the tissue wall from the foreside of the tissue wall to the blind side of the tissue wall into the anatomical cavity, wherein the occluding member, when detached from the elongated member, blocks the constricted portion of the first opening in the tissue wall from the blind side thereof when at least a portion of the occluding member is positioned in the anatomical cavity between the plurality of tissue piercing elements and in physical contact with a portion of the interior surface of the tissue wall that surrounds the first opening.

24. The medical system of claim 23, further comprising an elongated rod member, a portion of the elongated rod member sized for passage through the first opening into the anatomical cavity, wherein each of the constricting unit and the occluding member is releasably coupled to the elongated rod member.

25. The medical system of claim 24 wherein the elongated rod member is moveable along a first direction to insert the constricting unit and the occluding member into the anatomical cavity, and wherein the tissue piercing elements pierce the tissue wall from the blind side thereof during the constricting of the at least a portion of the first opening when the elongated member is moved along a second direction opposite to the first direction.

26. The medical system of claim 23 wherein at least part of the constricting unit is arranged to be delivered into the anatomical cavity through the first opening in the tissue wall from the foreside of the tissue wall to the blind side of the tissue wall to the location proximate the first opening in the tissue wall where the constricting unit is manipulable to constrict the at least a portion of the first opening.

27. The medical system of claim 26 wherein each tissue piercing element of at least some of the tissue piercing elements has a respective tip and is arranged to pierce the tissue wall tip first, each tip pointed rearwardly with respect to a direction of travel when at least part of the constricting unit is arranged to be delivered into the anatomical cavity through the first opening in the tissue wall from the foreside of the tissue wall to the blindside of the tissue wall to the location proximate the first opening in the tissue wall where the constricting unit is manipulable to constrict the at least a portion of the first opening.

28. The medical system of claim 26 wherein the occluding member is positioned with respect to at least part of the constricting unit to follow the at least part of the constricting unit through the first opening in the tissue wall into the anatomical cavity.

29. The medical system of claim 23 wherein the constricting unit constricts the at least a portion of the first opening in the tissue wall by a manipulation of each of the respective tissue piercing elements to pierce a respective one of a plurality of regions of the blind side of the tissue wall and by drawing the plurality of regions together, each of the regions located at least proximate to a port of the first opening in the tissue wall located on the blind side of the tissue wall.

30. The medical system of claim 23 wherein the occluding member comprises an inflatable member, the inflatable member comprising a flexible membrane selectively moveable between a retracted position when the occluding member is delivered through the first opening and an extended position in which the occluding member is sized sufficiently large to overlap and surround the first opening in the tissue wall on the blind side thereof.

31. The medical system of claim 30 wherein at least a portion of the flexible membrane is manipulable to block the constricted portion of the first opening in the tissue wall from the blind side thereof.

32. The medical system of claim 30 wherein at least a portion of the flexible membrane is manipulable to block the constricted portion of the first opening in the tissue wall from the blind side thereof when the flexible membrane is positioned in the retracted position.

33. The medical system of claim 23 wherein the constricting unit comprises an implantable clip that includes the plurality of tissue piercing elements.

34. The medical system of claim 23 wherein the occluding member comprises an inflatable member, and the medical system comprises a fluid source fluidly coupled to the inflatable member,

wherein the fluid source is selectively controllable to expand the inflatable member to increase a spacing between at least two of the tissue piercing elements, and

wherein the fluid source is selectively controllable to contract the inflatable member to cause the at least two piercing elements to pinch at least a portion of the tissue wall comprising the first opening when the at least two tissue piercing elements pierce the tissue wall from the blind side thereof during the constricting of the at least a portion of the first opening.

35. The medical system of claim 34 wherein at least a portion of the inflatable member is manipulable to block the constricted portion of the first opening from the blind side thereof when the flexible membrane is positioned in the retracted position.

36. The medical system of claim 34 wherein the inflatable member is positioned between the at least two piercing elements to prevent a pointed portion of each piercing element from extending beyond a surface of the inflatable member when the fluid source is selectively controlled to expand the inflatable member.

37. The medical system of claim 23 wherein the constricting unit is arranged to secure the at least a portion of the occluding member to the blind side of the tissue wall when the constricting unit constricts the portion of the first opening in the tissue wall.

38. The medical system of claim 37 wherein at least one of the tissue piercing elements is arranged to pierce into the occluding member to secure the at least a portion of the occluding member to the blind side of the tissue wall.

39. The medical system of claim 23 wherein the occluding member includes a pad which overlaps the first opening in the tissue wall from the blind side thereof and contacts the tissue wall surrounding the first opening in the tissue wall on the blind side to occlude the first opening.