Vascular plug having composite construction

• US 8,083,768 B2
• Filed: 01/19/2005
• Issued: 12/27/2011
• Est. Priority Date: 12/14/2000
• Status: Expired due to Fees

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Ensure Medical, Inc. (Cardinal Health, Inc.)
• Inventors: Ginn, Richard S., Palermo, Thomas J, Olsen, Phil, Hartridge, Tellis, Shively, Adam
• Primary Examiner(s): WOO, JULIAN W
• Application Number:
  US11/038,995
• Publication Number:
  US 20050267528A1
• Time in Patent Office: 2,533 Days
• Field of Search: 606/232, 606/151, 424422-425, 424/443, 424/444, 623/23.75, 623/23.76, 128830-833, 435/402, 530/356
• US Class Current: 606/232
• 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 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12163 having a string of elements connected to each other
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid

Abstract

This invention relates to apparatus and methods for use in sealing a vascular puncture site, particularly sites of punctures that are the result of catheterization or other interventional procedures. In several of the preferred embodiments, the sealing device includes a sealing member and a tether. The sealing member generally performs the function of occupying a space in an incision, puncture, or other wound and sealing the space in the incision, puncture, or wound that it occupies, to prevent further blood flow. The tether is typically attached in some manner to the sealing member, and provides the user with the ability to withdraw the sealing member if necessary. In a particularly preferred form, the sealing device further includes a restraining member associated with the sealing member. The restraining member provides the ability to more securely restrain the sealing member to prevent it from migrating from the deployment location within a tissue tract. The restraining member may also provide an additional capability of manipulating the sealing member after deployment.

Claims

1. A device for substantially sealing a wound that extends through tissue to an opening in a body lumen comprising:

a restraining member comprising a first bioabsorbable material and defining an interior space therein, a sealing member comprising a second bioabsorbable material at least partially located within the interior space of said restraining member, and an elongated tubular member, wherein the restraining member and the sealing member are releasably disposed in an unexpanded state within the elongated tubular member, and wherein at least the sealing member will expand when placed in the body lumen.

2. The device of claim 1 further comprising a tether attached at a first end to said sealing member.

3. The device of claim 1, wherein said first bioabsorbable material is the same as said second bioabsorbable material.

4. The device of claim 1, wherein said first bioabsorbable material is selected from the group consisting of polyglycolic acid, polylactide, polyglycol-lactide acid, collagen, and hydrogel.

5. The device of claim 1, wherein said restraining member comprises a porous member.

6. The device of claim 5, wherein said restraining member comprises a material having a knit, braided or woven construction.

7. The device of claim 5, wherein said restraining member is a tubular fabric member and said sealing member is a coiled foam pad enclosed by said tubular fabric member.

8. The device of claim 7, wherein said coiled form pad comprises a hydrogel.

9. A method for substantially sealing a wound that extends through tissue to an opening in a body lumen, comprising:

providing a sealing device comprising a hydrogel material, at least partially located within an interior space of a restraining member and deploying the sealing device in the wound through an elongated tubular member, wherein the sealing device is releasably disposed in an unexpanded state in the elongated tubular member and wherein at the sealing device will expand when placed in the body lumen, and wherein the restraining member comprises a bioabsorbable material.

10. The method of claim 9, wherein said sealing device further comprises a tether attached at a first end to said sealing device.

11. The method of claim 9, wherein said bioabsorbable material is selected from the group consisting of polyglycolic acid, polylactide, polyglycol-lactide acid, collagen, and hydrogel.

12. The method of claim 9, wherein said restraining member comprises a material having a knit, braided or woven construction.

13. The method of claim 12, wherein said restraining member is a tubular fabric member and said sealing member is a coiled foam pad enclosed by said tubular fabric member.

14. A device for substantially sealing a wound that extends through tissue to an opening in a body lumen comprising:

a sealing member, at least a portion of which having a first radial dimension for delivery of said sealing member into the wound and will expand to a second radial dimension upon delivery into said wound and exposure to fluid flow associated with said wound, the second radial dimension being larger than the first radial dimension, and wherein said sealing member comprises a hydrogel, further comprising a restraining member comprising a first bioabsorbable material and defining an interior space therein, said sealing member being located at least partially within the interior space of said restraining member and an elongated tubular member, wherein the sealing device is releasably disposed in a state with the first radial dimension within the elongated tubular member and wherein at least the sealing member will expand to the second radial dimension when placed in the body lumen.

15. The device of claim 14, further comprising a tether connected to said sealing member and having a length sufficient to extend externally of said wound after delivery of the sealing member.

16. The device of claim 15, further comprising a stop member at a terminal end of said tether, said stop device adapted to retain the sealing member on the tether.

17. The device of claim 14, wherein said first bioabsorbable material is selected from the group consisting of polyglycolic acid, polylactide, polyglycollactide acid, collagen, and hydrogel.