Vascular closure devices, systems, and methods of use

• US 8,961,541 B2
• Filed: 10/31/2008
• Issued: 02/24/2015
• Est. Priority Date: 12/03/2007
• Status: Expired due to Fees

• Current Assignee: CardioVascular Technologies, Inc.
• Original Assignee: CardioVascular Technologies, Inc.
• Inventors: Houser, Russell A.
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US12/263,322
• Publication Number:
  US 20090143789A1
• Time in Patent Office: 2,307 Days
• Field of Search: 606/213, 606/139, 606144-148, 606/142, 606/73, 606/95, 606/194
• US Class Current: 606/142
• 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 2017/00668 the implement being a tack or a staple

Abstract

A tissue closure system can include a deployment instrument and a sealing element. The deployment instrument can be slidably mounted to and guided by a tubular medical device. The deployment instrument can be advanced over the tubular medical device to the desired location. The sealing element can then be advanced off of the end of the tool. The sealing element can include tissue engaging elements that are configured to automatically close upon deployment to bring together tissue. A slidably attached guided skin (or other tissue) cutter can also be used if desired to facilitate entry of the deployment instrument.

Claims

1. A method of deploying a vascular closure device, comprising the steps of:

providing a deployment device having an inner tube and an outer tube, with a plug in a non-swelled state mounted on a distal end of the inner tube, wherein at least a portion of the plug is within the outer tube, the plug comprising a swellable material that swells when exposed to fluid, the plug further comprising a first portion having a first cross-sectional area and a second portion having a second cross-sectional area, the second cross-sectional area being larger than the first cross-sectional area, the plug having a longitudinal channel passing through the first and second portions;

advancing a distal end of the deployment device over an elongate medical device to an opening in a blood vessel such that said second portion of the plug is received against an outer wall of the vessel opening and said plug is exposed to a bodily fluid, wherein the plug remains mounted on the distal end of the inner tube and the portion of the plug within the outer tube remains therewithin when the second portion of the plug is received against the outer wall of the vessel opening; and

producing generally longitudinal movement between the inner tube and the outer tube of the deployment device to release the plug from the deployment device, wherein the inner tube pushes the plug free of the outer tube;

wherein the plug swells upon said exposure to the bodily fluid to substantially occlude the longitudinal channel, thereby sealing the vessel opening.

2. The method of claim 1 wherein the first portion of the plug is within the outer wall of the vessel when the second portion is received against the outer wall of the vessel.

3. The method of claim 1 wherein the longitudinal channel is coated with an adhesive or other coating configured to assist in occluding the longitudinal channel.

4. The method of claim 1 wherein the elongate medical device is within the longitudinal channel while advancing the distal end of the deployment device over the elongate medical device.

5. The method of claim 1 further comprising withdrawing the elongate medical device from the blood vessel prior to releasing the plug from the deployment device.

6. The method of claim 1 wherein the bodily fluid is blood, saline, or subcutaneous fluid.

7. The method of claim 1 wherein the plug is at least partially bioabsorbable.

8. The method of claim 7 wherein the plug is configured to be absorbed by the patient'"'"'s body after about 4 weeks.

9. The method of claim 1 wherein the plug includes a rigid outer coating that begins to dissolve upon exposure to the bodily fluid.

10. The method of claim 1 wherein the elongate medical device is one or more of the following:

introducer, sheath, dilator, trocar, endoscope, catheter, guide wire, needle, or tube.

11. The method of claim 1 wherein the inner tube has a handle and is moved longitudinally by applying pressure to the handle in a distal direction or by pulling the handle in a proximal direction.

12. The method of claim 1 wherein the inner tube has a handle and the outer tube has a handle, and a stop is provided that maintains separation between the inner tube handle and the outer tube handle.

13. The method of claim 12 further comprising removing the stop, thereby permitting the inner tube to move relative to the outer tube.

14. The method of claim 13 wherein the stop is a removable element affixed to the outer tube between the inner tube handle and the outer tube handle.

15. The method of claim 13 wherein the plug is fully deployed when the inner tube handle and the outer tube handle are brought together.

16. The method of claim 1 wherein the plug is partially or completely fabricated from polyethylene glycol (PEG).

17. The method of claim 1 wherein the plug comprises a contact surface with an adhesive or bonding compounds.

18. The method of claim 1 wherein the plug includes a therapeutic agent.

19. The method of claim 1, wherein the inner tube has an inner lumen configured to receive the elongate medical device.

20. The method of claim 19, wherein inner tube has an elongate slot allowing a proximal portion of the elongate medical device to be tilted away from and axially separated from the inner tube without detaching the deployment device from the elongate medical device when received by the inner lumen of the inner tube.

21. The method of claim 20, wherein the outer tube has an elongate slot aligned with the elongate slot of the inner tube.

22. The method of claim 1, wherein the plug includes a longitudinal slit or spiral allowing the plug to be attached to the elongate medical device or the deployment device from a side of the elongate medical device or the deployment device.

23. A method of deploying a vascular closure device, comprising the steps of:

providing a deployment device having an inner tube and an outer tube, with a plug in a non-swelled state mounted on a distal end of the inner tube, wherein a portion of the plug is within a distal end of the outer tube of the deployment device and a portion of the plug extends out of the distal end of the deployment device, the plug comprising a swellable material that swells when exposed to fluid, the plug further comprising a first portion having a first cross-sectional area and a second portion having a second cross-sectional area, the second cross-sectional area being larger than the first cross-sectional area, the plug having a longitudinal channel passing through the first and second portions;

advancing the distal end of the deployment device over an elongate medical device to an opening in a blood vessel such that said second portion of the plug is received against an outer wall of the vessel opening and said plug is exposed to a bodily fluid, wherein the plug remains mounted on the distal end of the inner tube and the portion of the plug within the distal end of the deployment device remains therewithin when the second portion of the plug is received against the outer wall of the vessel opening; and

producing generally longitudinal movement between the inner tube and the outer tube of the deployment device to release the plug from the deployment device;

wherein the plug swells upon said exposure to the bodily fluid to substantially occlude the longitudinal channel, thereby sealing the vessel opening.

24. The method of claim 23 wherein the portion of the plug that extends out of the distal end of the deployment device has the second cross-sectional area and the portion of the plug that is within the outer tube of the distal end of the deployment device has a smaller cross-sectional area than the second cross-sectional area.

25. The method of claim 23 wherein the first portion of the plug is within the outer wall of the vessel when the second portion is received against the outer wall of the vessel.

26. The method of claim 23 wherein the longitudinal channel is coated with an adhesive or other coating configured to assist in occluding the longitudinal channel.

27. The method of claim 23 wherein the elongate medical device is within the longitudinal channel while advancing the distal end of the deployment device over the elongate medical device.

28. The method of claim 23 further comprising withdrawing the elongate medical device from the blood vessel prior to releasing the plug from the deployment device.

29. The method of claim 23 wherein the bodily fluid is blood, saline, or subcutaneous fluid.

30. The method of claim 23 wherein the plug is at least partially bioabsorbable.

31. The method of claim 23 wherein the plug is configured to be absorbed by the patient'"'"'s body after about 4 weeks.

32. The method of claim 23 wherein the plug includes a rigid outer coating that begins to dissolve upon exposure to the bodily fluid.

33. The method of claim 23 wherein the elongate medical device is one or more of the following:

introducer, sheath, dilator, trocar, endoscope, catheter, guide wire, needle, or tube.

34. The method of claim 23 wherein the distal end of the inner tube pushes the plug free of the outer tube.

35. The method of claim 34 wherein the inner tube has a handle and is moved longitudinally by applying pressure to the handle in a distal direction or by pulling the handle in a proximal direction.

36. The method of claim 34 wherein the inner tube has a handle and the outer tube has a handle, and a stop is provided that maintains separation between the inner tube handle and the outer tube handle.

37. The method of claim 36 further comprising removing the stop, thereby permitting the inner tube to move relative to the outer tube.

38. The method of claim 37 wherein the stop is a removable element affixed to the outer tube between the inner tube handle and the outer tube handle.

39. The method of claim 37 wherein the plug is fully deployed when the inner tube handle and the outer tube handle are brought together.

40. The method of claim 23 wherein the plug is partially or completely fabricated from polyethylene glycol (PEG).

41. The method of claim 23 wherein the plug comprises a contact surface with an adhesive or bonding compounds.

42. The method of claim 23 wherein the plug includes a therapeutic agent.

43. The method of claim 23, wherein the inner tube has an inner lumen configured to receive the elongate medical device.

44. The method of claim 43, wherein inner tube has an elongate slot allowing a proximal portion of the elongate medical device to be tilted away from and axially separated from the inner tube without detaching the deployment device from the elongate medical device when received by the inner lumen of the inner tube.

45. The method of claim 44, wherein the outer tube has an elongate slot aligned with the elongate slot of the inner tube.

46. The method of claim 23, wherein the plug includes a longitudinal slit or spiral allowing the plug to be attached to the elongate medical device or the deployment device from a side of the elongate medical device or the deployment device.