Device and method for sealing a puncture in a blood vessel

• US 6,632,237 B2
• Filed: 01/11/2001
• Issued: 10/14/2003
• Est. Priority Date: 01/11/2001
• Status: Expired due to Fees

• Current Assignee: Bio SEAL Tech Incorporated
• Original Assignee: Bio SEAL Tech Incorporated
• Inventors: Ben-David, Shlomo, Mageni, Yohanan
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/757,623
• Publication Number:
  US 20020091410A1
• Time in Patent Office: 1,006 Days
• Field of Search: 606/213, 604/167.01
• US Class Current: 606/213
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3423 Access ports, e.g. toroid shape introducers for instruments or hands access sites for liquids A61M39/0247
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue

Abstract

A sealing device for a puncture in a blood vessel, device being slidingly receivable over a guide tube and comprising a tubular, resilient sealing member formed with a sealing portion spontaneously sealable upon deployment of the device into an activated state, an engaging portion for bearing against an external surface of the blood vessel and a plurality of anchors fitted at their fore end with fasteners for engaging a corresponding internal surface of the blood vessel and at a rear end with a manipulating bit. The anchors being displaceable between a constricted position in which they blend with the tubular sealing member, and an operative position in which the fasteners are laterally expanded and engage the internal surface of the blood vessel.

Claims

1. A sealing device for a puncture in a blood vessel, the device being slidingly receivable over a guide tube and comprising a tubular, resilient sealing member formed with a sealing portion spontaneously sealable upon deployment of the device into an activated state, an engaging portion for beating against an external surface of the blood vessel and a plurality of anchors fitted at their fore end with fasteners for engaging a corresponding internal she of the blood vessel and at a rear end with a manipulating bit;

said anchors being displaceable between a constricted position in which they blend with the tubular sealing member, and an to operative position in which the fasteners are lateral expanded and engage the internal surface of the blood vessel.

2. A sealing device according to claim 1, further comprising a plurality of tissue-grabbing members adapted for engaging with tissue portion surrounding the puncture, and an arrangement for applying to said tissue-grabbing members an inwardly directed radial force.

3. A sealing device according to claim 2, wherein the fasteners are fitted with spikes facing rearwards, for engaging tissue of the blood vessel.

4. A scaling device according to claim 3, wherein at the deployed state the anchors are biased radially inwardly, for constricting the size of the puncture in the blood vessel.

5. A sealing device according to claim 2, wherein the sealing member is fitted with a plurality of spear members for grabbing external wall surface of the blood vessel around the puncture and constricting the size of the puncture by applying thereto force in a radially-inward direction.

6. A sealing device according to claim 5, wherein the spear members have a rear head projecting from a rear end of the sealing member, a rear stem portion axially extending through a bore of the sealing member, a fore stem portion extending through a common cavity of the sealing member and pointed tissue engaging fore ends.

7. A sealing device according to claim 1, wherein the engaging portion of the sealing member is truncated, whereby upon engaging with the blood vessel the sealing member bears at an inclination thereover.

8. A sealing device according to claim 7, wherein the fasteners are axially graded, giving rise to an imaginary path extending between edges thereof, said path conforming with the truncated edge of the sealing member.

9. A sealing device according to claim 1, wherein each anchor comprises a stem portion axially extending along the sealing member, said stem being formed at its rear end with the manipulating bit and at its fore end with the fastener.

10. A sealing device according to claim 9, wherein a first portion of the stem extends through side walls of the sealing member and a second portion of the stem extends within a common cavity of the sealing member.

11. A sealing device according to claim 10, wherein the sealing member is formed with a plurality of bores extending only a portion of the length of the sealing member and rotationally receiving the first portion of each stem.

12. A sealing device according to claim 9, wherein at an operative position of the device the sealing member applies radial force on the stems of the anchors, urging the fasteners radially inwardly for constricting the size of the puncture formed at the blood vessel.

13. A sealing device according to claim 1, wherein the anchors are formed at their aft end with a manipulating bit temporarily engageable by a deploying member for displacing into the operative position.

14. A sealing device according to claim 1, deployable into its operative position by a deploying assembly comprising a tubular housing, a tubular controller received within the housing and a tubular pusher member received within the controller, coaxially received within one another;

said pusher adapted for manipulating the sealing member into its activated position.

15. A sealing device according to claim 14, wherein the pusher member has restricted axial displacement with respect to the housing.

16. A sealing device according to claim 15, wherein the pusher member is formed with at least one lateral projection exiting through a corresponding slot formed in the controller and a corresponding slot formed in the housing, thereby restricting the axial displacement of the pusher within the housing.

17. A sealing device according to claim 16, wherein the at least one slot formed in the controller and in the housing are formed at their front ends with a lateral extension allowing for rotation of the pusher member about its longitudinal axis.

18. A sealing device according to claim 14, wherein the pusher member has restricted rotational displacement with respect to the housing.

19. A sealing device according to claim 14, wherein at least a fore end of the housing is radio-opaque material.

20. A sealing device according to claim 14, wherein a fore end of the housing converges to a lesser diameter, said fore end being radially expandable to admit deployment therethrough of the sealing device.

21. A scaling device according to claim 14, wherein a sleeve is fitted into the pusher via the fore end of the housing, said sleeve extending also through the sealing device and retaining it in its constricted position.

22. A sealing device according to claim 14, wherein the controller is axially displaceable within the housing, whereby axially displacement thereof entails intrusion of the sealing member through the fore end of the housing.

23. A sealing device according to claim 14, wherein a fore end of the pusher member is formed with activating surfaces adapted for engagement with the manipulating bits of the anchors and deploying the anchors into the operative position.

24. A sealing device according to claim 23, wherein the activating surfaces are gliding surfaces inclined so as to engage with the manipulating bits at their constricted position and where rotation of the pusher member entails sliding displacement of the manipulating bits about said activating surfaces thereby deploying the anchors into their operative position.

25. A sealing device according to claim 1, wherein the tubular sealing member is biased to axially shrink.

26. A sealing device according to claim 1, wherein the sealing portion is a diaphragm with a normally closed flow path formed by a plurality of slots, intrinsically biased into close the flow path.

27. A sealing device according to claim 1, wherein at least a component of the sealing member is made of a biodegradable or bio-absorbable material.

28. A deploying assembly for deploying a sealing device according to claim 1, comprising a tubular housing, a tubular controller received within the housing and a tubular pusher member received within the controller, coaxially received within one another;

said pusher adapted for engagement with the manipulating bits of the sealing device and manipulating the sealing member into its activated position.

29. A method for sealing a puncture in a blood vessel, the method comprising the following steps:

(a) obtaining a sealing assembly comprising a sealing member fitted within an associated deploying assembly, with a sleeve extending through the sealing assembly, said sleeve defining a through-going path;

(b) introducing a medical guide tube through the path;

(c) removing the sleeve;

(d) carrying out a medical procure through the guide tube;

(e) slidingly displacing the sealing assembly over the guide tube until a fore end of the deploying assembly engages the blood vessel;

(f) expelling the sealing assembly from the deploying assembly and introducing anchor fastener members of the sealing assembly into the blood vessel through the puncture;

(g) deploying anchor faster members into an operative position in which they are laterally expanded and engage the internal surface of the blood vessel;

(h) disengaging the sealing assembly from the deploying assembly and withdrawing the guide tube, allowing a resilient sealing member formed in the sealing member to spontaneously seal.

30. A method according to claim 29, wherein at step (d) the guide tube is inserted into the blood vessel at an angle corresponding with a truncation angle of an engaging portion formed at the sealing member, for bearing against an external surface of the blood vessel.

31. A method according to claim 29, wherein at least step (e) is radio-monitored, whereby at least a fore end of the housing is radio-opaque material.

32. A method according to claim 29, wherein the anchors are biased radially inwardly, for constricting the size of the puncture in the blood vessel.

33. A method according to claim 29, wherein the fasteners of the fitted with rearwardly facing spikes whereby after step (e) axial force is applied to the sealing member in a rearward direction, thereby having the spikes engage tissue of the blood vessel.

34. A method according to claim 29, wherein the deploying assembly comprises a tubular housing, a tubular controller received within the housing and a tubular pusher member received within the controller, coaxially received within one another;

said pusher adapted for manipulating the sealing member into its activated position;

wherein step (f) is carried out by the following steps;

(a) axially displacing the controller within the housing in a forward direction;

(b) axially displacing the pusher within the controller.

35. A method according to claim 34, wherein the controller and housing are thread-engaged whereby step (a) is carried out by rotating the controller within the housing.

36. A method according to claim 34, wherein a fore end of the pusher member is formed with activating surfaces adapted for engagement with corresponding manipulating bits formed at rear ends of the anchors, whereby deploying the anchors into the operative position of step (g) is carried out by rotating the pusher within the housing.

37. A method according to claim 29, which after step (f) spear members are engaged with an external surface of the blood vessel surrounding to puncture and by applying inwardly directed radial force, the lips of the punctured blood vessel are adjoined, thereby decreasing the size of the puncture.