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

• US 6,551,331 B2
• Filed: 01/30/2001
• Issued: 04/22/2003
• 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., Brosh, Benjamin G., Nobles, Anthony A.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/773,046
• Publication Number:
  US 20010031973A1
• Time in Patent Office: 812 Days
• Field of Search: 606/139, 606/144, 606/147
• 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 suture mounting portion which mounts an end portion of a suture, said arm having a proximal portion and a distal portion, said arm being mounted to permit said proximal portion to move away from said body to a first position and towards said body to a second position; 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 to said suture mounting portion of said arm when said arm is in said first position.

2. The apparatus of claim 1, wherein said distal portion is disposed adjacent said body during said movement of said proximal portion.

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

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

5. A suturing device, comprising:

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

an arm mounted to move relative to said elongate body, said arm including a suture mounting portion and being actuatable between a first position wherein said arm is within said body and a second position wherein said arm is extended away from said body; and

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

6. The suturing device of claim 5, further comprising an actuator within said housing for actuating said arm between said first and second positions.

7. The suturing device of claim 6, wherein said actuator moves proximally to actuate said arm from said first position to said second position.

8. The suturing device of claim 5, comprising another of said arms.

9. The suturing device of claim 8, wherein said arms are substantially parallel to one another when said arms are in their second position.

10. The suturing device of claim 9, wherein each of said arms is substantially transverse to the longitudinal axis of the elongate housing when said arms are in their second position.

11. The suturing device of claim 8, wherein each of said arms is a separate piece.

12. A suturing apparatus, comprising:

an elongated body;

an arm mounted to move relative to said elongated body, said arm having a suture mounting portion which mounts a portion of a suture, said arm being mounted to move away from said body to an extended position and towards 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 within said elongated body to a position spaced outwardly from said body and to said suture mounting portion of said arm when said arm is in said extended position, such that said portion of said suture is engaged by said distal end of said needle.

13. The apparatus of claim 12, wherein said needle comprises a shaft portion and a tip portion, and wherein said suture comprises an eyelet disposed in said suture mounting portion, said eyelet sized to receive said distal end of said needle, such that said eyelet is captured by said needle.

14. The apparatus of claim 13, wherein said needle comprises a shoulder proximal to the tip portion, said shoulder sized to capture said eyelet.

15. The apparatus of claim 12, further comprising:

a second arm mounted to move relative to said elongated body, said second arm having a suture mounting portion which mounts another portion of said suture, said second arm being mounted to move away from said body to an extended position and towards said body to a retracted position; 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 within said elongated body to a position spaced outwardly from said body and to said suture mounting portion of said second arm when said second arm is in said extended position, such that said another portion of said suture is engaged by said distal end of said second needle.

16. The apparatus of claim 15, wherein both of said needles are configured to move relative to said elongated body at the same time.

17. The apparatus of claim 15, wherein said needles are configured to move relative to said elongated body at different times.

18. The apparatus of claim 17, wherein each of said needles is configured to penetrate a first tissue portion and said second needle, respectively, such that said first tissue portion and said second tissue portion are substantially drawn together when said portions of said suture are drawn together.

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

20. The apparatus of claim 19, wherein said elongated body comprises a needle guide for bending the needle.