Needle apparatus for closing septal defects and methods for using such apparatus

• US 20030050665A1
• Filed: 09/07/2001
• Published: 03/13/2003
• Est. Priority Date: 09/07/2001
• Status: Active Grant

• Current Assignee: Promed, Inc.
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Ginn, Richard S.
• Granted Patent: US 6,702,835 B2
• Time in Patent Office: Days
• US Class Current: 606/215
• 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 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture

Abstract

Apparatus and methods for closing a septal defect including a flap of tissue partially detached from a septum of a heart. A needle is advanced through a patient'"'"'s vasculature within a delivery apparatus until the needle is disposed within a first chamber adjacent the septum. The needle is directed through the flap of tissue until the needle is disposed within a second chamber opposite the septum. A filament attached to an intermediate region of the needle is pulled, thereby causing the needle to pivot about the intermediate region such that the ends of the needle straddle the septal opening. A locking element is secured to the filament to secure the flap of tissue against the septum, and the filament is cut. Alternatively, the filament is biased to coil to engage the flap of tissue and secure the needle against the septum to close the opening.

Claims

1. An apparatus for closing a septal defect, comprising:

an elongate needle comprising a first end defining a tissue-penetrating tip, and a second end defining a substantially blunt tip;

a filament extending from an intermediate portion of the needle between the first and second ends; and

a locking element securable to the filament, thereby preventing the locking element from moving along the filament away from the needle.

2. The apparatus of claim 1, wherein the needle has a tapered cross-section such that the second end is substantially larger than the first end.

3. The apparatus of claim 1, wherein the needle comprises a slot therein extending from the intermediate portion to the second end, the slot having a size for receiving a portion of the filament therein.

4. The apparatus of claim 1, wherein the filament is pivotally coupled to the intermediate portion of the needle.

5. The apparatus of claim 1, wherein the intermediate portion of the needle comprises a hole through which the filament is substantially secured to the needle.

6. The apparatus of claim 1, wherein the locking element comprises a clip slidable along the filament towards the needle, the clip comprising engaging elements for preventing the clip from being moved along the filament away from the needle.

7. The apparatus of claim 1, further comprising:

a tubular member comprising proximal and distal ends and a lumen therebetween, the distal end having a size for insertion into a blood vessel, the needle being carried within the lumen such that the first end is disposed distally to the second end; and

a pusher member slidably disposed within the lumen, the pusher member comprising a distal end disposed proximate the second end of the needle, the pusher member being movable axially relative to the tubular member for ejecting the needle distally from the lumen.

8. The apparatus of claim 7, wherein the pusher member comprises a lumen extending proximally from the distal end of the pusher member, and wherein the filament is received through the lumen.

9. The apparatus of claim 8, further comprising an actuator on the proximal end of the tubular member for advancing the pusher member relative to the tubular member such that the distal end of the pusher member extends a predetermined distance beyond the distal end of the tubular member.

10. The apparatus of claim 9, wherein the second end of the needle has a cross-section that is substantially larger than a cross-section of the distal end of the pusher member.

11. The apparatus of claim 10, wherein the second end of the needle comprises a flared outer edge such that the second end extends laterally from the distal end of the pusher member.

12. The apparatus of claim 9, wherein the actuator is coupled to the filament for pulling the filament proximally after the pusher member is advanced the predetermined distance.

13. The apparatus of claim 12, wherein the second end of the needle comprises a rounded edge for facilitating pivoting of the needle about the intermediate region when the filament is pulled proximally.

14. The apparatus of claim 1, further comprising a carrier member having a proximal end and a distal end having a size for introduction into a body lumen, and wherein the locking element is releasably carried by the distal end of the carrier member.

15. The apparatus of claim 14, wherein the locking element comprises opposing arms defining a space therebetween for receiving the filament therein, and wherein the carrier member comprises a hammer arrangement for plastically deforming at least one of the opposing arms to frictionally engage the filament.

16. The apparatus of claim 1, further comprising an imaging device comprising a imaging element associated with the distal end of the tubular member for imaging beyond the distal end of the tubular member.

17. The apparatus of claim 16, wherein the imaging device comprises an endoscope received within a lumen of the tubular member.

18. The apparatus of claim 16, wherein the imaging device comprises an elongate member comprising a distal end having a size for introduction into a body lumen.

19. A method for closing a septal defect within a patient'"'"'s heart, the septal defect comprising a flap of tissue partially detached from a septum wall between first and second chambers of the heart, the flap of tissue and surrounding tissue defining a septal opening through the septum wall, the method comprising:

providing a needle comprising a first end defining a tissue-penetrating tip, a second end defining a substantially blunt tip, and an intermediate portion between the first and second ends from which a filament extends;

advancing the needle through the patient'"'"'s vasculature until the needle is disposed within the first chamber of the heart adjacent the septal opening;

directing the first end of the needle through the flap of tissue until the second end passes through the flap of tissue and the needle is disposed within the second chamber of the heart;

pulling the filament, thereby causing the needle to pivot about the intermediate region such that the first and second ends of the needle straddle the septal opening within the second chamber; and

directing the flap of tissue into engagement with the septum wall to at least partially close the septal opening.

20. The method of claim 19, wherein the step of directing the flap of tissue comprises securing a locking element to the filament, the locking element engaging the proximal surface of the flap of tissue to secure the flap of tissue between the needle and the locking element.

21. The method of claim 20, wherein the step of securing the locking element comprises introducing a carrier member into the first chamber of the heart, the carrier member carrying the locking element.

22. The method of claim 20, wherein the carrier member is manipulated to receive the filament within a slot in the locking element, and wherein the locking element is crimped to secure the filament within the slot.

23. The method of claim 19, wherein a locking element comprises a clip slidably secured on the filament.

24. The method of claim 19, wherein the step of directing the flap of tissue comprises advancing the clip along the filament towards the needle until the flap of tissue is secured against the tissue surrounding the septal opening.

25. The method of claim 19, wherein the step of pulling the filament comprises slidably engaging the blunt tip of the needle along a distal surface of the flap of tissue, thereby causing the needle to pivot about the intermediate region of the needle.

26. The method of claim 25, wherein the blunt tip of the needle comprises a rounded inner edge for facilitating movement of the needle along the distal surface.

27. The method of claim 19, wherein the needle is disposed within a distal end of a delivery apparatus comprising a catheter and a pusher member slidably coupled to one another, and wherein the step of advancing the needle comprises advancing the distal end of the delivery apparatus into the first chamber until the distal end is disposed adjacent the flap of tissue.

28. The method of claim 27, wherein the step of directing the first end of the needle through the flap of tissue comprises advancing the pusher member distally relative to the catheter, thereby directing the needle from within the delivery apparatus.

29. An apparatus for closing a septal defect, comprising:

an elongate needle comprising a first end defining a tissue-penetrating tip, a second end defining a substantially blunt tip, and a longitudinal axis extending between the first and second ends; and

a filament extending from an intermediate portion of the needle between the first and second ends, at least a segment of the filament being biased towards a configuration defining a plane extending generally parallel to the longitudinal axis, the filament being resiliently extendable towards a generally linear configuration.

30. The apparatus of claim 29, wherein the needle has a tapered cross-section such that the second end is substantially larger than the first end.

31. The apparatus of claim 29, wherein the needle comprises a slot therein extending from the intermediate portion to the second end, the slot having a size for receiving a portion of the filament therein.

32. The apparatus of claim 29, wherein the filament comprises first and second segments, the first segment attached to the intermediate portion of the needle and biased to extend transversely with respect to the longitudinal axis, the second segment extending from the first segment and being biased to extend transversely to the first segment such that the second segment defines the plane.

33. The apparatus of claim 32, wherein the second segment is biased towards a coiled configuration, the coiled configuration lying substantially within the plane.

34. The apparatus of claim 32, wherein the second segment is biased towards a planar configuration lying substantially within the plane.

35. The apparatus of claim 34, wherein the planar configuration comprises at least one of an “

L,”

a “

U,”

a “

Y,” and

an “

s”

shape that lies substantially within the plane.

36. The apparatus of claim 29, further comprising:

a tubular member comprising proximal and distal ends and a lumen therebetween, the distal end having a size for insertion into a blood vessel, the needle being carried within the lumen such that the first end is disposed distally to the second end; and

a pusher member slidably disposed within the lumen, the pusher member comprising a distal end disposed proximate the second end of the needle, the pusher member being movable axially relative to the tubular member for ejecting the needle distally from the lumen.

37. The apparatus of claim 36, wherein the pusher member comprises a gripping mechanism for releasably securing a loose end of the filament, thereby restraining the filament in the generally linear configuration.

38. The apparatus of claim 37, further comprising an actuator on the proximal end of the pusher member for releasing the loose end of the filament, whereupon the filament becomes biased to assume the planar configuration.

39. The apparatus of claim 36, further comprising an imaging element associated with the distal end of the tubular member for imaging beyond the distal end of the tubular member.

40. A method for closing a septal defect within a patient'"'"'s heart, the septal defect comprising a flap of tissue partially detached from a septum wall between first and second chambers of the heart, the flap of tissue and surrounding tissue defining a septal opening through the septum wall, the method comprising:

providing a needle comprising a first end defining a tissue-penetrating tip, a second end defining a substantially blunt tip, and an intermediate portion between the first and second ends from which a filament extends;

advancing the needle through the patient'"'"'s vasculature until the needle is disposed within the first chamber of the heart adjacent the septal opening;

directing the first end of the needle through the flap of tissue until the second end passes through the flap of tissue and the needle is disposed within the second chamber of the heart;

pulling the filament, thereby causing the needle to pivot about the intermediate region such that the first and second ends of the needle straddle the septal opening within the second chamber; and

releasing the filament, the filament resiliently assuming a generally planar configuration, thereby engaging the flap of tissue between the needle and the filament to at least partially close the septal opening.