Devices for sealing openings through tissue and apparatus and methods for delivering them

• US 6,846,319 B2
• Filed: 12/14/2000
• Issued: 01/25/2005
• Est. Priority Date: 12/14/2000
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Core Medical Incorporated
• Inventors: Ginn, Richard S., Jabba, Ronald J., Salmon, Stephen M.
• Primary Examiner(s): NERBUN, PETER P
• Application Number:
  US09/738,431
• Publication Number:
  US 20020077656A1
• Time in Patent Office: 1,503 Days
• Field of Search: 606/213, 606/192, 606/191, 606/194, 606/195, 606/1, 606/65, 606/72, 606/73, 600/32, 623/11.11, 623/1.11, 604/8
• 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 2010/0003 including means for analysis by an unskilled person
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid

Abstract

An apparatus for sealing a passage through tissue includes an elongate shaft and a cylindrical plug disposed on a distal end of the shaft, the plug including a helical thread on its outer surface. Intestinal submucosa may be secured to the plug, e.g., in a cavity in its distal end, that may be delivered into the passage. Alternatively, the plug may be formed from a bioabsorbable material and may be released from the shaft within the passage. The plug is threaded into the passage, thereby engaging the tissue to seal the passage. The shaft is rotated until it engages a blood vessel within the tissue while monitoring blood flow through the vessel. The shaft is rotated to thread the plug into the passage until blood flow ceases through the vessel, whereupon rotation of the shaft is reversed to back the plug until blood flow through the vessel resumes.

Claims

1. In an apparatus for sealing a passage through tissue which communicates with a body lumen, the improvement comprising:

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

an opening in the proximal region of the elongate shaft,

a plug member disposed on the distal end of the elongate shaft, the elongate shaft having a cross-section that is substantially smaller than a cross-section of the plug member, and

an opening in the distal region of said plug,

wherein said plug member and said elongate shaft have a position indicating lumen therein which extends from the opening in the distal region of said plug to the opening in the proximal region-of said elongate shaft.

2. The apparatus of claim 1, wherein the plug member is at least partially tapered at its distal end.

3. The apparatus of claim 1, further comprising at least one of a hemostasis-promoting material and an infection-resistant material secured to a distal end of the plug member.

4. The apparatus of claim 1, wherein the plug member is releasable from the elongate shaft.

5. The apparatus of claim 4, wherein the elongate shaft comprises an actuator for releasing the plug member from the distal end of the elongate shaft.

6. The apparatus of claim 4, further comprising cooperating connectors on the distal end of the elongate shaft and on the plug member for releasably securing the plug member to the distal end of the elongate shall.

7. The apparatus of claim 4, wherein the plug member comprises bioabsorbable material.

8. The apparatus of claim 1, wherein the plug member is substantially permanently attached to the distal end of the elongate shaft.

9. The apparatus of claim 1, wherein the elongate shaft is provided with a seal for selectively sealing the lumen.

10. The apparatus of claim 9, wherein the seal is disposed on the proximal end of the elongate shaft.

11. In an apparatus for sealing a passage through tissue which communicates with a body lumen, the improvement comprising:

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

an opening in the proximal region of the elongate shaft,

a plug member substantially permanently attached to the distal end of the elongate shaft, and

an opening in the distal region of said plug,

wherein said plug member and said elongate shaft have a position indicating lumen therein which extends from the opening in the distal region of said plug to the opening in the proximal region of the elongate shaft.

12. The apparatus of claim 11, wherein the plug member is at least partially tapered at its distal end.

13. The apparatus of claim 11, wherein the plug member comprises a cavity in its distal end.

14. The apparatus of claim 13, further comprising at least one of a hemostasis-promoting material and an infection-resistant material disposed in the cavity.

15. The apparatus of claim 14, wherein the material comprises intestinal submucosa.

16. The apparatus of claim 11, further comprising at least one of a hemostasis-promoting material and an infection-resistant material secured to a distal end of the plug member.

17. The apparatus of claim 11, wherein the plug member comprises bioabsorbable material.

18. The apparatus of claim 11, wherein the elongate shaft is provided with a seal for selectively sealing the lumen.

19. The apparatus of claim 18, wherein the seal is disposed on the proximal end of the elongate shaft.

20. In an apparatus for sealing a passage through tissue which communicates with a body lumen, the improvement comprising:

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

an opening in the proximal region of the elongate shaft,

a plug member substantially permanently attached to the distal end of the elongate shaft, the plug member comprising a helical thread on its outer surface, the elongate member having a cross section that is substantially smaller than a cross section of the plug member, and an opening in the distal region of said plug wherein said plug member and said elongate shaft have a position indicating lumen therein which extends from the opening in the distal region of said plug to the opening in the proximal region of said elongate shaft.