Devices and methods for performing vascular anastomosis

• US 6,280,460 B1
• Filed: 02/13/1998
• Issued: 08/28/2001
• Est. Priority Date: 02/13/1998
• Status: Expired due to Fees

• Current Assignee: Heartport, Inc. (Johnson & Johnson)
• Original Assignee: Heartport, Inc. (Johnson & Johnson)
• Inventors: Bolduc, Lee R., Gannoe, James R., Johnson, Theodore C.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): NGO, LIEN M
• Application Number:
  US09/023,876
• Time in Patent Office: 1,292 Days
• Field of Search: 606/222, 606/144-159, 606/123-126, 606/223, 606/224, 606/228, 606/139
• US Class Current: 606/222
• 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
• 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 passing at least one needle through tissue, the device comprising:

a handle;

a shaft assembly including a shaft movably coupled to the handle, at least one needle removably supported by the shaft and movable between radially extended and non-extended positions, and a protective cover overlying at least a portion of the shaft and needle when the needle is in said radially non-extended position, the cover being movable with respect to the shaft to allow the needle to move to said radially extended position, the shaft assembly having a ram slidably disposed over the shaft for moving the needle into said radially extended position, the protective cover being slidably disposed over the ram; and

an actuator assembly operable using one hand for moving the cover to allow the needle to assume said radially extended position and moving the shaft to pass the needle through the tissue, the actuator assembly having a linkage coupled to a movable component, and movement of the movable component drives the linkage and moves the protective cover to allow the needle to assume said radially extended position, moves the ram to force the needle into said radially extended position, and moves the shaft to pass the needle through the tissue.

2. The device of claim 1, wherein the shaft comprises a solid rod, the ram comprises a first sleeve coaxially disposed over the solid rod, and the protective cover comprises a second sleeve coaxially disposed over the first sleeve.

3. The device of claim 1, wherein the shaft has proximal and distal ends, and the needle is supported at the distal end of the shaft.

11. The device of claim 1, further comprising a needle guard disposed around the needle when the needle is in said radially extended and non-extended positions.

12. The device of claim 11, wherein the needle guard comprises a cage disposed around the needle and movable between expanded and collapsed orientations.

16. The device of claim 1, wherein the shaft assembly is substantially straight over the length thereof.

4. A device for passing at least one needle through tissue, the device comprising:

a handle;

a shaft assembly including a shaft movably coupled to the handle, at least one needle removably supported by the shaft and movable between radially extended and non-extended positions, and a protective cover overlying at least a portion of the shaft and needle when the needle is in said radially non-extended position, the cover being movable with respect to the shaft to allow the needle to move to said radially extended position;

an actuator assembly operable using one hand for moving the cover to allow the needle to assume said radially extended position and moving the shaft to pass the needle through the tissue; and

at least one length of suture having two ends, one end being secured to the needle and the other end being removably supported by the shaft assembly.

5. The device of claim 4, wherein a first plurality of needles are removably supported adjacent the distal end of the shaft, and wherein one end of each of a plurality of lengths of sutures is secured to one of the needles, while the other end of each length of suture is removably supported by the shaft assembly.

6. The device of claim 5, further comprising a suture supporting member disposed on the shaft assembly, wherein the other end of each length of suture is removably supported by the suture supporting member.

7. The device of claim 6, wherein the suture supporting member comprises an inner sleeve having channels each of which receives a length of suture, and an outer tube disposed around the inner sleeve to enclose each length of suture in one of said channels.

8. The device of claim 6, wherein the suture supporting member is fixed to the handle assembly and has a distal end provided with a foot for contacting the tissue.

9. The device of claim 8, wherein the foot has a plurality of slots receiving the lengths of suture and the needles after the needles have passed through the tissue.

10. The device of claim 5, further comprising a second plurality of needles each of which is secured to the other end of one of the lengths of suture, wherein each of the second plurality of needles is removably supported by the shaft assembly.

13. A device for passing at least one needle through tissue, the device comprising:

a handle;

a shaft assembly including a shaft movably coupled to the handle, at least one needle removably supported by the shaft and movable between radially extended and non-extended positions, and a protective cover overlying at least a portion of the shaft and needle when the needle is in said radially non-extended position, the cover being movable with respect to the shaft to allow the needle to move to said radially extended position; and

an actuator assembly operable using one hand for moving the cover to allow the needle to assume said radially extended position and moving the shaft to pass the needle through the tissue;

a needle oguard disposed around the needle when the needle is in said radially extended and non-extended positions, the needle guard having a cage disposed around the needle and movable between expanded and collapsed orientations,

the cage having a plurality of flexible struts having one end secured to the shaft and another end secured to a ram slidably disposed over the shaft, wherein sliding the ram with respect to the shaft moves the needle into said radially extended position and moves the cage into said expanded orientation.

14. A device for passing at least one needle through tissue, the device comprising:

a handle assembly which is generally pistol shaped;

a shaft assembly including a shaft movably coupled to the handle, at least one needle removably supported by the shaft and movable between radially extended and non-extended positions, and a protective cover overlying at least a portion of the shaft and needle when the needle is in said radially non-extended position, the cover being movable with respect to the shaft to allow the needle to move to said radially extended position; and

an actuator assembly operable using one hand for moving the cover to allow the needle to assume said radially extended position and moving the shaft to pass the needle through the tissue, the actuator assembly having a trigger slidably mounted on the handle assembly.

15. The device of claim 14, wherein the trigger is movable in one direction to move the cover and the shaft, and the actuator assembly is provided with a mechanism preventing movement of the trigger in a different direction.

17. A device for passing at least one needle through tissue, the device comprising:

a handle;

a shaft assembly including a shaft movably coupled to the handle, at least one needle removably supported by the shaft and movable between radially extended and non-extended positions, and a protective cover overlying at least a portion of the shaft and needle when the needle is in said radially non-extended position, the cover being movable with respect to the shaft to allow the needle to move to said radially extended position the shaft assembly having a proximal portion adjacent the handle assembly and a distal portion, and the distal portion being angled with respect to the proximal portion; and

an actuator assembly operable using one hand for moving the cover to allow the needle to assume said radially extended position and moving, the shaft to pass the needle throuoh the tissue.

18. A device for passing a plurality of needles and a plurality of separate lengths of suture through tissue in a patient'"'"'s body, the device comprising:

a handle;

a shaft assembly supporting a plurality of needles and a plurality of separate lengths of sutures, the shaft assembly having a distal portion configured to be positioned adjacent tissue of a patient'"'"'s body through which the needles are to be passed, wherein the needles are located adjacent the distal portion of the shaft assembly and are movable between an extended position and a non-extended position, and one end of each length of suture is secured to one of the needles and the other end of each length of suture is located away from the needles; and

an actuator assembly operable to pass the needles through tissue.

19. The device of claim 18, wherein the shaft assembly includes a shaft to which the needles are mounted so as to be movable in a radial direction between said extended and non-extended positions, and the actuator is operable to move the shaft and pass the needles through tissue.

20. The device of claim 19, wherein the shaft assembly comprises a ram slidably disposed over the shaft for moving the needles into said radially extended position, and a protective cover slidably disposed over the ram.

21. The device of claim 20, wherein actuation of the actuator assembly moves the protective cover in a first direction, moves the ram in a second direction to force the needles into said radially extended position, and moves the shaft in said first direction to pass the needles through the tissue.

22. The device of claim 21, wherein the ram comprises a solid rod with individual portions each con-esponding to one of the needles, and the actuator assembly moves the individual portions of the ram in unison to force the needles into said radially extended position at the same time.