Handle for suturing apparatus

• US 20060069397A1
• Filed: 09/27/2005
• Published: 03/30/2006
• Est. Priority Date: 09/27/2004
• Status: Active Grant

• Current Assignee: Gary S. Kohler, Pandora Select Partners, L.P., Scarab Technology Services, LLC, Scot W. Malloy
• Original Assignee: Nobles Medical Technologies, Inc (Medtronic Plc)
• Inventors: Decker, Steven E., Nobles, Anthony A., Tran, Hung, Brosch, Benjamin G.
• Granted Patent: US 7,803,167 B2
• Time in Patent Office: Days
• US Class Current: 606/144
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 2017/00296 mounted on an endoscope
• CPC Class Codes: A61B 2017/00367 Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/2911 rings
• CPC Class Codes: A61B 2017/2912 transmission of forces to actuating rod or piston

Abstract

Methods and apparatus are provided for closing incisions within biological tissue. In one embodiment, a device and method are provided for suturing biological tissue, such as, for example, an organ or blood vessel. The suturing apparatus is particularly well suited for suturing an incision made in an artery, such as the femoral artery, following a catheterization procedure. The device eliminates the need to apply pressure to a patient'"'"'s thigh for an extended period of time, and eliminates many of the complications and costs associated with the creation of a thrombus patch. In addition, the device comprises an improved handle portion which enables the physician to quickly and easily apply suture. The handle portion is very reliable and easy to manipulate. The suturing may be used in combination with existing catheter sheath introducers.

Claims

1. A suturing apparatus, comprising:

an elongate body;

an arm mounted to move relative to said elongate body, said arm having a suture mounting portion which mounts an end portion of a suture;

a needle having a distal end, said needle mounted to move relative to said elongate body; and

a handle attached to said elongate body, said handle comprising an actuator having a camming surface and a follower having a cammed surface, said follower connected to move said needle, said camming surface and cammed surface interacting in response to movement of said actuator to drive said follower to move said needle.

2. The apparatus of claim 1, wherein said handle has a longitudinal axis, and wherein at least a portion of said cammed surface is inclined at at least about 35°

relative to said axis.

3. The apparatus of claim 1, wherein said handle has a longitudinal axis, and wherein at least a portion of said cammed surface is inclined at at least about 40°

relative to said axis.

4. The apparatus of claim 1, wherein said handle has a longitudinal axis, and wherein at least a portion of said cammed surface is inclined at about 41°

relative to said axis.

5. The apparatus of claim 1, wherein said handle has a longitudinal axis, and wherein at least a portion of said cammed surface is inclined at between 35-45°

relative to said axis.

6. The apparatus of claim 1, wherein said handle has a longitudinal axis, and wherein at least a portion of said cammed surface is inclined at between 39-43°

relative to said axis.

7. The apparatus of claim 1, wherein said handle has a longitudinal axis, and wherein at least a portion of said cammed surface is inclined at between 40-42°

relative to said axis.

8. The apparatus of claim 1, wherein the camming surface is curved.

9. The apparatus of claim 1, wherein said handle comprises a second actuator having a second camming surface and a second cammed surface which interact in response to movement of said second actuator to move said arm.

10. The apparatus of claim 1, wherein said actuator rotates about an axis generally orthogonal to a longitudinal axis of the handle.

11. The apparatus of claim 1, wherein said elongate body includes a port for receiving a guide wire.

12. The apparatus of claim 1, comprising a second needle and a second arm.

13. The apparatus of claim 1, wherein said elongate body is flexible.

14. The apparatus of claim 1, including a finger loop on said actuator for manually retracting the actuator with a finger.

15. A suturing apparatus, comprising:

an elongate body;

an arm mounted to move relative to said elongate body, said arm having a suture mounting portion which mounts an end portion of a suture;

a needle having a distal end, said needle mounted to move relative to said elongate body, said distal end of said needle movable; and

a handle attached to said elongate body, said handle comprising an actuator and a follower connected to move said needle by an amount equal to movement of the follower;

wherein the amount of movement of said follower is visible to the user, such that the amount of movement of the needle may be monitored without directly viewing the needle.

16. The apparatus of claim 15, wherein the handle has a housing portion comprised of transparent material, said follower visible to the user through the transparent material.

17. The apparatus of claim 15, wherein the needle moves from a start position to a finish position in response to movement of the actuator, and wherein the handle includes indicia that at least indicates the position of the follower when the needle is in the finish position.

18. The apparatus of claim 17, wherein the indicia further indicates the position of the follower when the needle is in the start position.

19. A suturing apparatus, comprising:

an elongate body;

an arm mounted to move relative to said elongate body, said arm having a suture mounting portion which mounts an end portion of a suture;

a needle having a distal end, said needle mounted to move relative to said elongate body; and

a handle attached to said elongate body, said handle comprising an actuator having a camming surface and a follower having a cammed surface, said follower connected to move said needle, such that movement of the follower in a distal direction drives the needle in a distal direction and movement of the follower in a proximal direction drives the needle in a proximal direction, said follower being spring biased towards a proximal direction, said actuator having a range of movement, said camming surface and cammed surface interacting to drive said follower in a distal direction during at least a substantial portion of said range of movement.

20. The apparatus of claim 19, wherein said actuator has a first finish position, said interaction of said cammed surface and camming surface being released in said first finish position such that said spring biasing drives said follower in a proximal direction, thereby automatically retracting the needle in a proximal direction, without retracting the actuator from the first finish position.

21. The apparatus of claim 20, wherein said actuator has a second finish position in which said spring biasing further retracts the needle, said actuator and said follower are relatively configured such that said follower is driven in a proximal direction at a substantially faster rate upon reaching said second finish position than upon reaching said first finish position.

22. The apparatus of claim 19, wherein said actuator has a finish position in which said needle is at a distal end of a range of movement of the needle, said spring biasing of said follower retracting the needle in a proximal direction in response to retraction of the actuator from the finish position.

23. The apparatus of claim 19, comprising a follower retractor member for manually retracting the follower and the needles in the event that said spring biasing of said follower fails to retract the needles.

24. A method of applying suture to an opening, comprising:

inserting an elongate body into the opening;

extending at least one arm from the elongate body on a distal side of the opening, the at least one arm holding a suture portion;

advancing at least one needle from the elongate body from the proximal side of the opening, through tissue adjacent the opening, and into engagement with the suture portion held by the at least one arm; and

retracting the at least one needle in a distal to proximal direction, pulling the suture portion proximally through the opening;

wherein the needle is advanced by moving an actuator from a first position to a second position and is biased to retract to its first position.

25. The method of claim 24, wherein the actuator is depressed to advance the needle.

26. The method of claim 25, wherein the needle retracts by releasing the actuator to return to its first position.

27. The method of claim 25, wherein the needle automatically retracts by further depressing the actuator.

28. The method of claim 24, wherein the needle is spring biased to return to its first position.

29. A method of applying suture to an opening, comprising:

inserting an elongate body into the opening, the elongate body being connected to a handle having a plurality of actuators;

depressing a first actuator to extend at least one arm from a first position to a second position, the arm in its second position extending from the elongate body on a distal side of the opening, the at least one arm holding a suture portion;

depressing a second actuator to advance at least one needle from the elongate body from the proximal side of the opening, through tissue adjacent the opening, and into engagement with the suture portion held by the at least one arm;

retracting the at least one needle in a distal to proximal direction, pulling the suture portion proximally through the opening; and

retracting the arm to its first position.

30. The method of claim 29, further comprising depressing a third actuator to return the at least one arm from its second position to its first position.

31. The method of claim 29, wherein the needle is retracted by returning the second actuator to its initial position.

32. The method of claim 29, wherein the needle is spring biased to return to its initial position.

33. A method of advancing a needle, comprising:

providing an actuator capable of being depressed;

providing a follower having an angled surface, the follower being connected with the needle and the angled surface being engageable with a surface of the actuator; and

depressing the actuator to advance the needle, wherein the distance moved by the needle is proportional to the angle of the angled surface.

34. A method of closing an incision in a body, comprising:

providing a suturing device having a handle portion and an elongate body, the elongate body having a distal end portion sized for insertion through a vessel wall, the suturing device having two deployable suture arms for holding ends of a suture and two extendable needles for grabbing the ends of the suture from the arms,

advancing the elongate body through an incision in the vessel wall;

depressing a first actuator on the handle portion for deploying the suture arms within the vessel;

depressing a second actuator on the handle portion for extending the needles through the vessel wall for grabbing the ends of the suture from the suture arms;

releasing the second actuator for withdrawing the needles and pulling the suture ends through the vessel wall;

releasing the first actuator for retracting the suture arms;

withdrawing the suturing device from the body; and

tying the ends of the suture for closing the incision.

35. The method of claim 34, wherein the first actuator is releasably securable in the depressed position.

36. The method of claim 34, wherein a first follower member is coupled to the suture arms by an actuating rod, and wherein depression of the first actuator causes the first follower member to translate longitudinally within the handle portion for causing the arms to deploy.

37. The method of claim 34, wherein a second follower member is coupled to the needles, and wherein depression of the first actuator causes the second follower member to translate longitudinally within the handle portion for causing the needles to extend.