Device and method for sealing puncture wounds

• US 5,830,130 A
• Filed: 10/05/1994
• Issued: 11/03/1998
• Est. Priority Date: 09/21/1990
• Status: Expired due to Term

• Current Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories)
• Original Assignee: Datascope Corporation (Getinge AB)
• Inventors: Ruttgers, Gunther, Saper, Lawrence, Janzen, Ernst, Wolvek, Sid
• Primary Examiner(s): STRIGHT, RONALD K
• Application Number:
  US08/318,380
• Time in Patent Office: 1,490 Days
• Field of Search: 606/213, 606/215, 606/191, 604/11, 604/14-17, 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, 604/68, 604/181, 604/187, 604/183, 604/218, 602/43-53
• 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 through a tissue channel and against the outside wall of a blood vessel of a patient wherein the blood vessel wall has a puncture having a predetermined width therein adjacent the tissue channel, the tissue channel and the 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 the puncture such that said charge of hemostatic material cannot enter the blood vessel through the puncture,

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

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

(d) a tissue dilator having a size substantially corresponding to said width of said charge of hemostatic material for slidably engaging said inner diameter of said hollow insertion sheath and for advancing said hemostatic material through said hollow insertion sheath to the outside of the vessel wall around the puncture without ever actually entering the lumen of the blood vessel.

2. The device of claim 1, wherein said charge of hemostatic material is in the form of a liquid.

3. The device of claim 2 wherein said liquid is comprised of fibrin glue.

4. The device of claim 2 wherein said liquid is comprised of thrombin.

5. The device of claim 1, wherein said charge of hemostatic material is in the form of a paste.

6. The device of claim 5 wherein said paste is comprised of fibrin glue.

7. The device of claim 5 wherein said paste is comprised of thrombin.

8. The device of claim 1, wherein said charge of hemostatic material is in the form of a plug of loose fibers.

9. The device of claim 1, wherein said charge of hemostatic material is in the form of a sponge.

10. The device of claim 1, wherein said charge of hemostatic material is in the form of a plug having a front end and a back end and wherein said front end is covered with a membrane of hemostatic material and wherein the remainder of said plug is in the form of a densely packed material.

11. The device of claim 1, wherein said charge of hemostatic material is in the form of a balloon made of collagen membrane.

12. A device for use in sealing a puncture having a predetermined width in a wall of a blood vessel of a patient where the blood vessel is separated from the skin of the patient by a layer of tissue, where a tissue channel communicates between the puncture and the patient'"'"'s skin and where a guide wire having proximal and distal ends extends at least from the puncture, through the channel, to the patient'"'"'s skin, the tissue channel and the puncture having been formed by an original procedure sheath, comprising

(a) a tissue dilator having a front portion and a rear portion,

(b) a dilator channel running through said tissue dilator from said front portion to said rear portion, said dilator channel being adapted to receive therein and pass therethrough the proximal end of said guide wire,

(c) 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 the puncture,

(d) hemostatic material having a width greater than said predetermined width of the puncture, whereby said hemostatic material is slidable within said inner diameter of said hollow insertion sheath, and said hemostatic material cannot enter the blood vessel through the puncture, and

(e) means for inserting said hemostatic material into said hollow insertion sheath,

said tissue dilator having a size substantially corresponding to said width of said hemostatic material for slidably engaging said inner diameter of said hollow insertion sheath and for advancing said hemostatic material through said hollow insertion sheath to the outside of the vessel wall around the puncture without ever actually entering the lumen of the blood vessel.

13. The device of claim 12, wherein said hemostatic material is in the form of a plug of loose fibers.

14. The device of claim 12, wherein said hemostatic material is densely packed.

15. The device of claim 12, wherein said hemostatic material is in the form of a plug having a front end and a back end and wherein said front end is covered with a membrane of hemostatic material and wherein the remainder of said plug is in the form of a densely packed sponge of hemostatic material.

16. The device of claim 12, wherein said hemostatic material is in the form of a balloon having a collagen membrane.