Medical graft connector or plug structures, and methods of making and installing same

• US 6,391,036 B1
• Filed: 03/31/2000
• Issued: 05/21/2002
• Est. Priority Date: 01/30/1998
• Status: Expired due to Term

• Current Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical ATG Incorporated (Abbott Laboratories Incorporated)
• Inventors: Peterson, Alex Alden, Berg, Todd Allen, Wahlberg, Mark D.
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/540,665
• Time in Patent Office: 781 Days
• Field of Search: 606/151, 606/153, 606/155, 606/156, 411/502, 411/503, 411/508, 411/509, 411/510, 292/35, 292/37, 623/1.1, 623/23.64, 604/174, 128/898
• US Class Current: 606/151
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• 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 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11

Abstract

A medical graft connector or plug is made, for example, by cutting end portions of a tube of highly elastic material axially at numerous locations spaced circumferentially around the tube to produce a plurality of fingers which extend axially from each end of an uncut medial portion of the tube. The fingers are deflected radially outwardly from the medial portion and set in that condition. For a graft connector, the medial portion is coaxially connected to an end portion of a tubular graft. The connector is then installed through an aperture in the side wall of a patient'"'"'s tubular body conduit, for example, by using a delivery tube in which the fingers are elastically deflected back to approximately their initial positions. When the delivery conduit is withdrawn from the connector, the fingers spring out to engage the inner and outer surfaces of the body conduit wall. For a plug, the medial portion is occluded and then the structure is installed through the aperture to be plugged in a manner similar to installation of the connector.

Claims

1. The method of making a medical graft connector comprising:

providing a metal tube;

substantially axially cutting an axial end portion of the tube at a plurality of locations spaced circumferentially around the axial end portion to convert the axial end portion to a plurality of fingers that extend substantially axially from an adjacent end of another axial portion of the tube;

deflecting the fingers substantially radially out from the other axial portion; and

setting the fingers as deflected in the deflecting.

2. The method defined in claim 1 wherein the setting comprises:

heat treating the fingers.

3. The method of making a medical graft assembly comprising:

making a medical graft connector by the method defined in claim 1; and

substantially coaxially attaching the medical graft connector to a tubular graft conduit.

4. The method of making an assembly for installing a medical graft comprising:

making a medical graft assembly by the method defined in claim 3; and

substantially coaxially surrounding the medical graft assembly with a delivery structure which elastically deflects the fingers inwardly toward parallelism with a central longitudinal axis of the other axial portion.

5. The method of installing a medical graft comprising:

providing an assembly for installing a medical graft by the method defined in claim 4;

inserting the delivery structure through an aperture in a side wall of a patient'"'"'s tubular body conduit; and

shifting the delivery structure relative to the medical graft assembly and the tubular body conduit so that the delivery structure is removed from the aperture but the medical graft connector is left extending through the aperture with the fingers again extending substantially radially out from the other axial portion inside the tubular body conduit.

6. The method defined in claim 1 further comprising:

substantially axially cutting a second axial end portion of the tube remote from the axial end portion at a second plurality of locations spaced circumferentially around the second axial end portion to convert the second axial end portion to a second plurality of second fingers that extend substantially axially from an adjacent second end of the other axial portion of the tube;

deflecting the second fingers substantially radially out from the other axial portion; and

setting the second fingers as deflected in the deflecting of the second fingers.

7. The method defined in claim 1 further comprising:

perforating the other axial portion.

8. The method defined in claim 1 further comprising:

pointing free ends of the fingers.

9. The method defined in claim 1 further comprising:

barbing free end portions of the fingers.

10. The method defined in claim 1 wherein the deflecting comprises:

concave curving the fingers as viewed from a plane extending radially out from the other axial portion.

11. The method defined in claim 1 wherein the tube is provided with a substantially round cross section.

12. The method defined in claim 1 wherein the tube is provided with a substantially elliptical cross section.

13. The method defined in claim 6 wherein the deflecting of the fingers and the deflecting of the second fingers cause free end portions of the fingers to overlap with free end portions of the second fingers.

14. The method defined in claim 1 wherein the tube is provided with different wall thickness at different locations along its length.

15. The method defined in claim 1 wherein the cutting causes each finger to have different width at different locations along its length.

16. The method defined in claim 1 wherein the tube is provided with an axial end which is transverse but not perpendicular to a longitudinal axis of the tube.

17. The method defined in claim 1 further comprising:

providing structure on free end portions of the fingers configured to facilitate releasable retention of the fingers in a condition in which they extend substantially parallel to a longitudinal axis of the other axial portion.

18. The method of making an assembly for installing a medical graft comprising:

making a medical graft assembly by the method defined in claim 3; and

placing a removable structure around the fingers to releasably retain the fingers in a condition in which they extend substantially parallel to a longitudinal axis of the other axial portion.

19. The method of installing a medical graft comprising:

providing an assembly for installing a medical graft by the method defined in claim 18;

inserting the assembly for installing a medical graft part way through an aperture in a side wall of a patient'"'"'s tubular body conduit so that the fingers are inside the tubular body conduit; and

removing the structure from around the fingers so that the fingers can again extend radially out from the other axial portion inside the tubular body conduit.

20. The method defined in claim 1 further comprising:

providing an elastic web between adjacent ones of the fingers.

21. The method defined in claim 1 further comprising:

providing a second tube of an elastic material;

substantially axially cutting an axial end portion of the second tube at a second plurality of locations spaced circumferentially around the axial end portion of the second tube to convert that axial end portion to a second plurality of second fingers that extend substantially axially from an adjacent end of a second other axial portion of the second tube;

deflecting the second fingers substantially radially out from the second other axial portion;

setting the second fingers as deflected in the deflecting of the second fingers; and

assembling the other axial portion substantially concentrically inside an axial end section of a tubular graft conduit and the second other axial portion substantially concentrically outside the axial end section.

22. The method defined in claim 21 wherein the assembling is performed so that the fingers extend out of the axial end section and so that the second fingers extend in a direction which is generally away from the fingers extending out of the axial end section.

23. The method defined in claim 21 wherein the assembling comprises:

securing the other axial portion and the second other axial portion relative to one another via the axial end section.

24. The method defined in claim 23 wherein the securing comprises:

suturing the other axial portion and the second other axial portion to one another through the axial end section.

25. The method of making a medical plug comprising:

providing a metal tube;

substantially axially cutting an axial end portion of the tube at a plurality of locations spaced circumferentially around the axial end portion to convert the axial end portion to a plurality of fingers that extend substantially axially from an adjacent end of another axial portion of the tube;

deflecting the fingers substantially radially out from the other axial portion;

setting the fingers as deflected in the deflecting; and

occluding the other axial portion.

26. The method defined in claim 25 wherein the setting comprises:

heat treating the fingers.

27. The method of making an assembly for installing a medical plug comprising:

making a medical plug by the method defined in claim 25; and

substantially coaxially surrounding the medical plug with a delivery structure which elastically deflects the fingers inwardly toward parallelism with a central longitudinal axis of the other axial portion.

28. The method of installing a medical plug comprising:

providing an assembly for installing a medical plug by the method defined in claim 27;

inserting the delivery structure through an aperture in a patient'"'"'s body tissue; and

shifting the delivery structure relative to the medical plug and the body tissue so that the delivery structure is removed from the aperture but the medical plug is left extending through the aperture with the fingers extending substantially radially out from the other axial portion on one side of the body tissue.

29. The method defined in claim 25 further comprising:

substantially axially cutting a second axial end portion of the tube at a second plurality of locations spaced circumferentially around the second axial end portion to convert the second axial end portion to a second plurality of second fingers that extend substantially axially from an adjacent end of the other axial portion;

deflecting the second fingers substantially radially out from the other axial portion; and

setting the second fingers as deflected in the deflecting of the second fingers.

30. The method of making an assembly for installing a medical plug comprising:

making a medical plug by the method defined in claim 29; and

substantially coaxially surrounding the medical plug with a delivery structure which elastically deflects the fingers and the second fingers inwardly toward parallelism with a central longitudinal axis of the other axial portion.

31. The method of installing a medical plug comprising:

providing an assembly for installing a medical plug by the method defined in claim 30;

inserting the delivery structure through an aperture in a patient'"'"'s body tissue; and

shifting the delivery structure relative to the medical plug and the body tissue so that the delivery structure is removed from the aperture but the medical plug is left extending through the aperture with the fingers again extending radially out from the other axial portion on one side of the body tissue and the second fingers again extending radially out from the other axial portion on an opposite side of the body tissue.

32. The method defined in claim 25 further comprising:

pointing free ends of the fingers.

33. The method defined in claim 25 further comprising:

barbing free end portions of the fingers.

34. The method defined in claim 25 wherein the deflecting comprises:

concave curving the fingers as viewed from a plane extending radially out from the other axial portion.

35. The method defined in claim 25 wherein the tube is provided with a substantially round cross section.

36. The method defined in claim 25 wherein the tube is provided with a substantially elliptical cross section.

37. The method defined in claim 29 wherein the deflecting causes free end portions of the fingers to overlap with free end portions of the second fingers.

38. The method defined in claim 25 wherein the tube is provided with different wall thickness at different locations along its length.

39. The method defined in claim 25 wherein the cutting causes each finger to have different width at different locations along its length.

40. The method defined in claim 25 further comprising:

providing structure on free end portions of the fingers configured to facilitate releasable retention of the fingers in a condition in which they extend substantially parallel to a longitudinal axis of the other axial portion.

41. The method of making an assembly for installing a medical plug comprising:

making a medical plug by the method defined in claim 25; and

placing a removable structure around the fingers to releasably retain the fingers in a condition in which they extend substantially parallel to a longitudinal axis of the other axial portion.

42. The method of installing a medical plug comprising:

providing an assembly for installing a medical plug by the method defined in claim 41;

inserting the assembly for installing a medical plug part way through an aperture in a patient'"'"'s body tissue so that the fingers extending from one end of the other axial portion pass through the aperture; and

removing the structure from around the fingers that extend from said one end of the other axial portion so that those fingers can again extend radially out from the other axial portion and engage tissue around the aperture.

43. The method defined in claim 25 further comprising:

providing an elastic web between adjacent ones of the fingers.