Suturing device and method for sealing an opening in a blood vessel or other biological structure

• US 6,245,079 B1
• Filed: 12/23/1999
• Issued: 06/12/2001
• Est. Priority Date: 08/24/1995
• Status: Expired due to Term

• Current Assignee: Scarab Technology Services, LLC
• Original Assignee: Sutura Incorporated
• Inventors: Decker, Steven E., Nobles, Anthony A., Brosh, Benjamin G.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/471,866
• Time in Patent Office: 537 Days
• Field of Search: 606/139, 606/143, 606/144, 606/145, 606/146
• 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 17/0483 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 17/0491 Sewing machines for surgery
• 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 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/2911 rings

Abstract

A suturing device allows a physician to remotely seal an incision in a blood vessel or other biological tissue. The device comprises an elongated tubular body having a distal portion which is adapted to be inserted percutaneously through the incision and into the blood vessel. The distal portion has first and second retractable arms which extend from the distal portion of the body and releasably hold a suture within the blood vessel. First and second retractable needles, each of which is configured to catch the suture from a respective arm, are provided along the body proximal to the retractable arms. The arms and the needles are remotely movable by the physician using a handle or other control mechanism provided at a distal portion of the device. In operation, the arms are initially deployed within the blood vessel to hold the ends of the suture beyond the circumference of the tubular body. The needles are then deployed from and then retracted into the body, during which time the needles pierce the vessel wall on opposite sides of the incision, release the suture ends from the retractable arms, and pull the suture through the vessel wall. The device is particularly useful for closing an incision in an artery following a catheterization procedure. In one embodiment, the catheter sheath introducer (CSI) used to perform the catheterization procedure is left in place during the suturing procedure.

Claims

1. A suturing apparatus, comprising:

an elongate body;

an arm mounted to move relative to said elongate body, said arm having a needle receiving portion which mounts an end portion of a suture, said arm having a proximal side and a distal side, said arm being hingedly mounted to permit said proximal side to move away from said body to a first position and towards said body to a second position, said distal side being disposed adjacent said body during said movement of said proximal side; and

a needle having a distal end, said needle mounted to move relative to said elongate body, said distal end of said needle movable from a position adjacent said elongate body to a position spaced outwardly from said body and within said needle receiving portion of said arm when said arm is in said first position.

2. The apparatus of claim 1, wherein said needle comprises a shaft portion and tip portion, and wherein said apparatus comprises an eyelet disposed in said needle receiving portion, said eyelet sized to receive said distal end of said needle and to engage said needle by interference fit.

3. The apparatus of claim 1, wherein the needle comprises a shoulder proximal to the tip portion, said shoulder sized to capture said eyelet.

4. A suturing apparatus, comprising:

an elongated body;

an arm mounted to move relative to said elongated body, said arm having a needle receiving portion which mounts an end portion of a suture, said arm having a proximal side and a distal side, said arm being hingedly mounted at said distal side to permit said proximal side to move away from said body to an extended position and toward said body to a retracted position; and

a needle having a distal end, said needle mounted to move relative to said elongated body, said distal end of said needle movable from a position adjacent said elongated body to a position spaced outwardly from said body and within said needle receiving portion of said arm when said arm is in said extended position, such that the end portion of the suture is engaged by the distal end of the needle.

5. The apparatus of claim 4, wherein said needle comprises a shaft portion and tip portion, and wherein said suture comprises an eyelet disposed in said needle receiving portion, said eyelet sized to receive said distal end of said needle, such that said eyelet is captured by said needle.

6. The apparatus of claim 4, wherein the needle comprises a shoulder proximal to the tip portion, said shoulder sized to cap said eyelet.

7. The apparatus of claim 4, further comprising:

a second arm mounted to move relative to said elongated body, said second arm having a needle receiving portion which mounts a second end portion of a suture, said second arm having an extended position in which said arm extends away from said body and a retracted position in which said arm is against said body; and

a second needle having a distal end, said second needle mounted to move relative to said elongated body, said distal end of said second needle movable from a position adjacent said elongated body to a position spaced outwardly from said body and within said needle receiving portion of said second arm when said second arm is in said extended position, such that the second end portion of the suture is engaged by the distal end of the second needle.

8. The apparatus of claim 7, wherein the first and second needles are configured to move relative to said elongated body at the same time.

9. The apparatus of claim 7, wherein the first and second needles are configured to move relative to said elongated body at different times.

10. The apparatus of claim 9, wherein the first needle is configured to penetrate a first tissue portion and the second needle is configured to penetrate a second tissue portion, such that the first tissue portion and the second tissue portion are substantially drawn together when the end portions of the suture are drawn together.

11. The apparatus of claim 10, further comprising a patch adapted to occlude a space between the fist and second portions of tissue.

12. The apparatus of claim 4, wherein the elongated body is adapted to bend the needle away from the body as it is advanced to penetrate tissue.

13. The apparatus of claim 12, wherein the elongated body comprises a needle guide for bending the needle.

14. A method of suturing a vessel, comprising:

providing a housing having a proximal end and a distal end and an actuating rod therein;

attaching a suture to at least one needle point, said needle point being removably attached to a deformable arm, said deformable arm being fixed to an end of the actuator rod;

pushing the actuating rod distally such that the deformable arm moves from an undeployed position with the needle point positioned inside the housing to a deployed position with the needle point positioned outside the housing and beyond the circumference of the housing into an internal passageway of a vessel through an opening in the vessel;

pulling the actuating rod proximally such that the needle point penetrates the wall of the vessel; and

catching the needle point with a suture catch and pulling the suture catch proximally such that the needle point is removed from the arm.

15. The method of claim 14, wherein the needle point is press fit onto the deformable arm.

16. The method of claim 14, wherein the deformable arm is made of a shape memory material.

17. The method of claim 16, wherein the deformable arm is at rest when in the deployed position.

18. The method of claim 14, further comprising moving the actuating rod proximally following catching the needle point with the suture catch to pull the arm into the housing.

19. The method of claim 14, wherein the suture is attached to a pair of needle points, each needle point being correspondingly removably attached to a deformable arm.

20. The method of claim 14, wherein the suture catch is a rod extending longitudinally along the housing.

21. The method of claim 20, wherein the suture catch includes a V-shaped notch and a cavity for holding the needle point.

25. The method of claim 21, wherein introducing the needle point into the internal passageway comprises pushing the actuating rod through the housing to allow the arm to move the needle point from within the housing into the internal passageway.

22. A method of suturing a vessel, comprising:

attaching a suture to at least one needle point, said needle point being attached to an arm;

introducing the needle point into an internal passageway of a vessel through an opening in a wall of the vessel;

penetrating the vessel wall from within the internal passageway with the needle point; and

pulling the needle point with the suture from outside the vessel away from the vessel wall, said pulling of the needle point detaching the needle point from the arm.

23. The method of claim 22, wherein the needle point is introduced through a housing.

24. The method of claim 23, wherein the arm is operably connected to an actuating rod within the housing.

26. A suturing device for suturing an opening in a wall of a vessel, comprising:

a housing;

an actuating rod supported within the housing;

at least one arm having a first end fixed to the actuating rod and a second end;

at least one needle point adapted to hold a suture and configured to penetrate biological tissue, the needle point being removably connected to said arm at said second end, wherein the actuating rod is moveable within the housing from a first position in which the arm is in an undeployed position and the needle point is inside the housing, to a second position in which the arm is in a deployed position and the needle point is outside the housing and beyond the circumference of the housing in an internal passageway of the vessel, and to a third position in which the needle point penetrates into the wall of the vessel; and

at least one suture catch adapted to engage the needle point after the needle point has penetrated the wall of the vessel, wherein when said suture catch is moved in a direction away from the arm, the needle point disengages from the arm to carry the suture with the needle point.

27. The suturing device of claim 26, wherein the needle point is press fit onto the arm.

28. The suturing device of claim 26, wherein the arm is deformable.

29. The suturing device of claim 28, wherein the deformable arm is made of a shape memory material.

30. The suturing device of claim 29, wherein the deformable arm is at rest when in the deployed position.

31. The suturing device of claim 26, wherein the suture catch is a rod extending longitudinally along the housing.

32. The suturing device of claim 26, wherein said suture catch has a cavity for holding the needle point.

33. A suturing device, comprising:

an elongate housing having a proximal end and a distal end;

at least one arm mounted to move relative to said elongate body, said arm including a needle receiving portion and being actuatable between a first and second position, said needle receiving portion being substantially within said housing in said first position and said needle receiving portion disposed outwardly away from said housing in said second position; and

a needle having a distal end, said needle mounted to move longitudinally along at least a portion of the extension of said elongate body in a proximal to distal direction and into said needle receiving portion when said arm is in said second position.

34. The suturing device of claim 33, further comprising an actuator within said housing for actuating said arm between said first and second positions.

35. The suturing device of claim 34, wherein said actuator moves proximally to actuate said arm from said first position to said second position.

36. The suturing device of claim 33, comprising a pair of arms.

37. The suturing device of claim 36, wherein each of said arms is substantially parallel to one another when said arms are in their second position.

38. The suturing device of claim 37, wherein each of said arms is substantially transverse to the longitudinal axis of the elongate housing.

39. The suturing device of claim 36, wherein each of the arms is a separate piece.

40. A method of suturing a vessel, comprising:

holding a suture with at least one suture clasp, the suture clasp being contained inside an elongate housing;

introducing the elongate housing containing the suture clasp and suture into an internal passageway of a vessel through an opening in a wall of the vessel;

moving the suture clasp from inside the elongate housing to outside the elongate housing;

piercing the vessel wall with a suture catch;

catching the suture with the suture catch after the suture clasp is moved outside away from the elongate housing; and

penetrating the vessel wall with the suture, the step of penetrating comprising retracting the suture catch from the vessel wall.