Device and method for sealing puncture wounds

• US 5,591,204 A
• Filed: 10/05/1994
• Issued: 01/07/1997
• Est. Priority Date: 09/21/1990
• Status: Expired due to Term

• Current Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories Incorporated)
• Original Assignee: Datascope Corporation (Getinge AB)
• Inventors: Janzen, Ernst, Saper, Lawrence, Ruttgers, Gunter
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): STRIGHT, RONALD K
• Application Number:
  US08/318,381
• Time in Patent Office: 825 Days
• Field of Search: 606/213, 606/215, 606/191, 604/11, 604/14-17, 604/18, 604/46, 604/47, 604/52, 604/53, 604/57, 604/59, 604/60, 604/93, 604/158, 604/164, 604/171, 604/173, 604/310, 604/311, 604/285-288, 604/367, 604/368, 128/887
• 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 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening

Abstract

A device is proposed for inserting hemostatic material through a tissue channel and against the outside wall of a blood vessel of a patient, wherein the blood vessel wall has a puncture therein adjacent the tissue channel. The device includes a charge of hemostatic material and a hollow sheath adapted to pass through the tissue channel, the sheath having a cross sectional profile larger than the puncture. The device places the hemostatic material in the hollow sheath and advances the hemostatic material through the sheath to the outside of the vessel wall around the puncture.

Claims

1. A device for inserting hemostatic material inward through a tissue channel until it is disposed by an outside wall of a blood vessel of a patient, said blood vessel wall having a puncture having a predetermined width therein adjacent said tissue channel, said tissue channel and said puncture having been formed by an original procedure sheath, comprising:

(a) a charge of hemostatic material having a width greater than said predetermined width of said puncture, such that the material cannot enter the blood vessel,

(b) a hollow insertion sheath adapted to pass through said tissue channel and having an inner diameter, said inner diameter of said insertion sheath being larger than said predetermined width of said puncture whereby said charge of hemostatic material can slidably engage said inner diameter of said hollow insertion sheath,

(c) means for placing said hemostatic material in said hollow insertion sheath, and

(d) means for advancing said hemostatic material through said hollow insertion sheath inward to the outside of said vessel wall around said puncture,

whereby said charge of hemostatic material cannot enter said blood vessel through said puncture.

2. The device of claim 1 further comprising a tissue dilator, wherein said insertion sheath is adapted to fit over said tissue dilator.

3. The device of claim 2 wherein said dilator is larger in cross section than said tissue channel and wherein said dilator is adapted to be inserted into said channel, thereby to increase the size of said channel.

4. The device of claim 2 wherein said dilator is larger in cross section than said puncture.

5. The device of claim 2 wherein said hemostatic material is made at least primarily of collagen.

6. The device of claim 1, 2, 3, 4 or 5 wherein said charge of hemostatic material is in the form of a plug partially of loose fibers and partially of a more densely packed construction.

7. A device for use in sealing a puncture having a predetermined width in a wall of a blood vessel of a patient where said blood vessel is separated from the skin of the patient by a layer of tissue, where a tissue channel communicates between said puncture and the patient'"'"'s skin, said tissue channel and said puncture having been formed by an original procedure sheath, comprising:

(a) an elongated hollow insertion sheath having a distal end, a proximal end, and an inner diameter, said inner diameter of said hollow insertion sheath being larger than said predetermined width of said puncture,

(b) hemostatic material, having a width greater than said predetermined width of said puncture such that the material cannot enter the blood vessel, whereby said hemostatic material can slidably engage said inner diameter of said hollow insertion sheath,

(c) means for inserting said hemostatic material into said insertion sheath, and

(d) means for advancing said hemostatic material through said insertion sheath, out of the distal end thereof and inward until it is disposed by said vessel wall by said puncture,

whereby said charge of hemostatic material cannot enter said blood vessel through said puncture.

8. The device of claim 7 wherein said means for inserting said hemostatic material into said insertion sheath is the same as said means for advancing said hemostatic material through said insertion sheath.

9. The device of claim 8 wherein said hemostatic material is made at least primarily of collagen.

10. The device of claim 7, wherein said hemostatic material insertion means further comprises a plug holder to retain therein said hemostatic material prior to its insertion into said insertion sheath.

11. The device of claim 7 or 10 wherein said hemostatic material is made at least primarily of collagen.

12. The device of claim 7 or 10 wherein said hemostatic material is in the form of a plug partially of loose fibers and partially of one of a densely packed and a sponge-like material.