Insertion assembly and method of inserting a vessel plug into the body of a patient

• US 5,591,205 A
• Filed: 06/06/1995
• Issued: 01/07/1997
• Est. Priority Date: 10/01/1990
• Status: Expired due to Term

• Current Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories Incorporated)
• Original Assignee: Quinton Instrument Co. (Cardica Incorporated)
• Inventors: Fowler, Bradford C.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US08/470,816
• Time in Patent Office: 581 Days
• Field of Search: 606/213, 606/215, 606/230, 604/15, 604/285-288
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• 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 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/06 Blood vessels

Abstract

A device and method of closing an incision or puncture in a patient by inserting a vessel plug into the incision or puncture until the distal end of the vessel plug is adjacent to the outer lumen of the blood vessel or target organ so that the vessel plug does not obstruct the flow of fluid through the blood vessel or target organ. The precise positioning of the vessel plug in the incision or puncture is accomplished through the use of a balloon catheter or a cylindrical insertion assembly having a proximal plunger member associated therewith.

Claims

1. An assembly for sealing an incision formed in the body of a patient wherein the incision extends from the skin of the patient into a target organ or blood vessel of the patient, said assembly comprising:

an elongate vessel plug formed of a hemostasis promoting material and having distal and proximal portions and said vessel plug adapted to be received in the incision such that said distal portion is located at a first predetermined position in the incision adjacent to the outer surface of the target organ or blood vessel of the patient and said vessel plug is positioned in the incision to obstruct the flow of fluids therethrough; and

a removable positioning member having an outer diameter and a length sufficient to extend between the skin of the patient and the blood vessel of the patient to identify the location of the blood vessel through the incision and determine said first predetermined position therefrom.

2. The assembly of claim 1 wherein said positioning member further includes an elongate passageway therein.

3. The assembly of claim 2 wherein said positioning member includes distal and proximal end portions thereon and said passageway is in communication with a plunger member operatively associated with the proximal end portion thereof.

4. The assembly of claim 1 wherein said hemostasis promoting material is sized to be received in said positioning member prior to use.

5. The assembly of claim 1 wherein said assembly includes a plunger member in operative contact with said hemostatic promoting material to move said hemostasis promoting material to said predetermined position in the incision as determined by said positioning member.

6. The assembly of claim 5 wherein said hemostasis promoting material includes a clotting agent therein.

7. The assembly of claim 5 wherein said hemostasis promoting material includes a tissue thromboplastin therein.

8. A method of sealing an incision formed in the body of a patient wherein the incision extends generally from the skin of a patient into a selected blood vessel of the patient, the method comprising;

inserting a positioning member into the incision and blood vessel to determine the location of the blood vessel through the incision, and

inserting a hemostasis promoting material into the incision along a portion of the positioning member such that the hemostasis promoting material is positioned in the incision in accordance with the location determined by the positioning member to seal the incision from the flow of blood passing through the blood vessel without extending into the blood vessel.

9. The method of claim 8 further including the step of inflating a balloon member on the positioning member to limit the movement of the hemostasis promoting material in the incision thereby preventing the hemostasis promoting material from being positioned in the blood vessel of the patient.

10. The method of claim 8 further including the step of inserting a radio-opaque material into the incision along with the hemostasis promoting material into the incision.

11. The method of claim 8 further including the step of manually increasing the diameter of at least a portion of the positioning member prior to inserting the hemostasis promoting material into the incision.

12. The method of claim 11 further including the step of positioning the hemostasis promoting material along the outer diameter of the positioning member in the incision.

13. The method of claim 8 further including the step of causing the positioning member to contact the wall of the blood vessel as the positioning member is positioned adjacent to the blood vessel.

14. The method of claim 8 further including the step of causing the hemostasis promoting material to be aligned with the wall of the blood vessel as the outer diameter of the positioning member contacts the wall of the blood vessel.