Devices and methods for performing vascular anastomosis

• US 6,709,441 B2
• Filed: 04/23/2001
• Issued: 03/23/2004
• Est. Priority Date: 02/13/1998
• Status: Expired due to Term

• Current Assignee: Heartport, Inc. (Johnson & Johnson)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Gannoe, James R., Johnson, Theodore C., Bolduc, Lee R.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/840,262
• Publication Number:
  US 20010021856A1
• Time in Patent Office: 1,065 Days
• Field of Search: 606/153, 606/155, 606/156
• US Class Current: 606/153
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 2017/00946 malleable
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/2924 Translation movement of handle without rotating movement
• CPC Class Codes: A61B 2017/2927 the angular position of the head being adjustable with respect to the shaft

Abstract

Devices and methods for performing vascular anastomosis. A needle passer is used to pass one or more needles through tissue to thread one or more lengths of suture through the tissue. The needle passer is operable using one hand and includes a handle supporting a shaft assembly carrying first and second sets of needles connected by lengths of suture. An actuator assembly uncovers the first set of needles, moves them into a radially extended position, and then passes them through tissue, for example, the wall of a patient'"'"'s aorta. The needle passer may be pistol-shaped with a trigger that is moved in one direction to sequentially uncover, radially extend, and move the first set of needles through the aorta around an aortotomy. The needles may then be pulled away from the patient to thread the suture through the tissue. A delivery device is used to deliver a member adapted to be secure to body tissue, such as a vascular conduit. The delivery device includes a shaft and a collar mounted for relative movement. The shaft supports a vascular conduit so that an end of the conduit is disposed against the collar. A sealing element may be positioned on the collar beneath the end of the conduit. The needles in the second set are removed from the needle passer and are placed through the conduit and sealing element and into the collar. The shaft is then moved through the collar to move the vascular conduit along the suture into contact with the aorta. The delivery device is then removed and the respective ends of each suture length secured to fix the end of the vascular conduit to the aorta.

Claims

1. A device for delivering a member adapted to be secured to a patients'"'"' body tissue, the device comprising:

a first component;

a second component mounted to the first component, the first and second components being relatively movable;

the first component being configured to removably support a member adapted to be secured to a patient'"'"'s body tissue;

the second component being configured to hold at least one needle carrying suture for securing the member to the body tissue;

wherein the first component is relatively movable with respect to the second component to move the member along the suture into contact with the body tissue.

2. The device of claim 1, further comprising a sealing element configured to be carried by the first component.

3. The device of claim 2, further comprising a vascular conduit supported by the first component, the conduit having an end overlying the sealing element.

4. A device for delivering a vascular conduit to body tissue located at an anastomosis site within a patient'"'"'s body, the device comprising:

a shaft having a proximal end and a distal end, a portion of the shaft being configured to support a vascular conduit adapted to be anastomosed to body tissue;

a collar disposed on the shaft, the shaft and collar being slidably movable with respect to one another, the collar having an area configured to hold at least one needle adapted to be passed through a vascular conduit supported by the shaft.

5. The device of claim 4, wherein the shaft comprises a tube with a hollow interior configured to receive the vascular conduit.

6. The device of claim 5, wherein the tube has a cut-out section for positioning the vascular conduit within the hollow interior of the tube.

7. The device of claim 4, further comprising a sealing element configured to engage an end of the vascular conduit.

8. The device of claim 7, wherein the sealing element comprises a ring having a closed periphery.

9. The device of claim 7, wherein the sealing element has a surface provided with at least one member for engaging an end of a vascular conduit to hold the conduit on the sealing element.

10. The device of claim 9, wherein the sealing element has a plurality of barbs for engaging an end of a vascular conduit.

11. The device of claim 4, wherein the distal end of the shaft has at least one radially extending flange for supporting an end of a vascular conduit.

12. The device of claim 11, wherein the distal end of the shaft has a pair of radially extending flanges for supporting an end of a vascular conduit.

13. The device of claim 4, wherein the collar has a proximal end, a distal end, and a bore in which the shaft is slidably mounted.

14. The device of claim 13, wherein the bore of the collar is frictionally engaged with the shaft.

15. The device of claim 13, wherein the shaft has a guide element along at least a portion of the exterior thereof, and the collar has a slot slidably engaged with the guide.

16. The device of claim 13, wherein the area on the collar configured to hold at least one needle comprises a sleeve surrounding at least part of the shaft, and the sleeve is formed so as to grip a needle placed therein.

17. The device of claim 16, wherein the sleeve is formed of a resilient material.

19. The method of claim 14, wherein the member is adapted to be secured to the body tissue adjacent an opening in the body tissue, and the suture passes through the body tissue adjacent the opening.

18. A method for delivering a member adapted to be secured to body tissue to a location adjacent the body tissue, the method comprising steps of:

placing suture through body tissue so that the suture extends away from the body tissue, the suture having an end which carries a needle;

providing a delivery device comprising first and second components mounted so as to be relatively movable;

positioning a member adapted to be secured to the body tissue on the first component;

placing the needle carried by the end of the suture into the second component; and

imparting relative movement to the first and second components to move the first component and the member along the suture to a location adjacent the body tissue.

20. The method of claim 18, wherein separate lengths of suture are placed through the body tissue and extend through the opening and through the tissue, each length of suture having an end which carries a needle.

21. The method of claim 20, wherein the member is adapted to be secured over the opening in the body tissue, and the lengths of suture extend through the opening and pass through the tissue at locations spaced around the opening.

22. The method of claim 21, wherein the member is a vascular conduit, and the opening in the body tissue is formed in patient'"'"'s aorta, and the vascular conduit is moved along the suture into contact with the aorta and then anastomosed thereto.

23. The method of claim 22, further comprising positioning a sealing member between the first component and the vascular conduit, and then securing the vascular conduit to the body tissue with the sealing member therebetween.

24. The method of claim 23, further comprising the step of measuring the size of the vascular conduit and selecting a particular size sealing member.

25. The method of claim 24, wherein the cutting instrument comprises four cutting surfaces and the opening has four flaps.

26. The method of claim 18, wherein the opening in the tissue is formed by a surgical cutting instrument comprising a plurality of cutting surfaces configured to cut an opening in tissue having a plurality of flaps.

27. An anastomosis system for securing a vascular conduit to a hollow body structure, the system comprising:

a needle passer comprising a shaft assembly supporting at least one length of suture secured to first and second needles, and an actuator for moving at least one of the needles through tissue of a hollow body structure to thread the length of suture through the tissue to permit an end of a vascular conduit to be attached to the tissue in fluid communication with the hollow body structure; and

a sealing element configured to be positioned against the end of the vascular conduit, the sealing element being formed of a material that is able to receive one of the first and second needles.

28. The system of claim 27, wherein the sealing element is ring-shaped and is formed of a resilient material.

29. A method for anastomosing a vascular conduit to a hollow body structure so that the vascular conduit is in fluid communication with the interior of the hollow body structure, the method comprising steps of:

forming an opening in tissue of a hollow body structure so that the opening passes into an interior of the body structure;

positioning an end of a vascular conduit against the tissue; and

attaching the vascular conduit to the tissue so that the vascular conduit is in fluid communication with the interior of the hollow body structure, wherein a sealing element is used to enhance the attachment between the end of the vascular conduit and the tissue.

30. The method of claim 29, wherein the end of the vascular conduit is positioned against the tissue, and the sealing element is positioned against the end of the vascular conduit to force the end of the vascular conduit against the tissue.

31. The method of claim 30, wherein the sealing element is a ring and the ring is positioned around the vascular conduit and forces the end of the vascular conduit against the tissue.