Device for sealing hemostatic incisions

• US 5,630,833 A
• Filed: 03/24/1995
• Issued: 05/20/1997
• Est. Priority Date: 07/16/1992
• Status: Expired due to Term

• Current Assignee: Sherwood Medical Company (Medtronic Plc)
• Original Assignee: Sherwood Medical Company (Medtronic Plc)
• Inventors: Thomas, David G., Allison, Richard D., Katsaros, Georges
• Primary Examiner(s): SCHMIDT, JEFFREY
• Application Number:
  US08/409,787
• Time in Patent Office: 788 Days
• Field of Search: 606/213, 606/215, 606/216, 128/887, 604/51, 604/59, 604/60, 604/285, 604/286, 600/32, 623/11, 623/12
• 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 or resorptive

Abstract

A device for sealing incisions in the body of a patient wherein the device includes a bioabsorbable sealing member having an elongate shaft member and an elastomeric and flexible balloon member. The device may also include a preformed or injectable collagenous material associated therewith to hemostatically seal the incision in the body of the patient. The shaft member may include one or more lumens extending therethrough in flow communication with one or more balloon members thereon to provide a relatively simple device which effectively seals an incision in the body of a patient.

Claims

1. A device for sealing an incision which extends between the skin and a blood vessel in the body of a patient, the device comprising:

a bioabsorbable member for sealing the incision wherein said bioabsorbable member includes a first member having an elongate shaft member having a lumen therein and an expandable member operatively associated therewith, said shaft member and expandable member being sized to extend through the incision and at least one of said first member and said expandable member being constructed in such a manner so as to be absorbable within the body of the patient after a period of time sufficient for permitting the effective sealing of the incision.

2. The device of claim 1 wherein said expandable member includes a first radial diameter for insertion of said first member through the incision and a second radial diameter for operatively retaining said shaft member in a predetermined position in the incision in use.

3. The device of claim 1 wherein said shaft member is an elongate member having a lumen extending therethrough and wherein said lumen is in communication with said expandable member.

4. An assembly for sealing or closing an incision or puncture in the body of a living patient wherein the incision or puncture extends into a blood vessel of the patient, the assembly comprising:

a bioabsorbable elongate shaft member having a proximal end and a distal end and having a bioabsorbable expandable member disposed at said distal end, said expandable member constructed to be positioned alternatively in a relaxed condition and an expanded condition;

said shaft member and said expandable member dimensioned to be inserted within the puncture so that said expandable member is positioned within a blood vessel of the patient;

control member associated with said shaft member and in communication with said expandable member for selectively positioning said expandable member between said expanded condition and said relaxed condition; and

a slidable member operatively associated with said shaft member for insertion into the incision or puncture, said expandable member configured to cooperate with said slidable member when said expandable member is in said expanded condition to prevent said slidable member from extending into the blood vessel of the patient.

5. The assembly as defined in claim 4 further including an introducer having a lumen extending longitudinally therethrough, said introducer dimensioned to receive said shaft member and said expandable member within said lumen.

6. An assembly for sealing or closing an incision or puncture in the body of a living patient wherein the incision or puncture extends into a blood vessel or an organ of the patient, the assembly comprising:

a bioabsorbable elongate shaft member having a proximal end and a distal end and having a bioabsorbable expandable member disposed at said distal end, said expandable member constructed to be positioned alternatively in a relaxed condition and an expanded condition;

said shaft member and said expandable member dimensioned to be inserted within the puncture so that said expandable member is positioned within a target organ or blood vessel of the patient;

control member associated with said shaft member and in communication with said expandable member for selectively positioning said expandable member between said expanded condition and said relaxed condition;

.

a slidable member operatively associated with said shaft member for insertion into the incision or puncture, said expandable member configured to cooperate with said slidable member when said expandable member is in said expanded condition to prevent said slidable member from extending into the blood vessel or the organ of the patient; and

wherein said slidable member is a cylindrical member constructed of a biodegradable material.

7. An apparatus for sealing or closing an incision or puncture in the body of a living patient wherein the incision or puncture extends into a blood vessel or an organ of the patient, the apparatus comprising:

a bioabsorbable tubular member having a proximal end and a distal end and having an expandable member disposed at said distal end of said tubular member, said expandable member constructed to be absorbed in the body of the patient and positioned alternatively in a relaxed condition and an expanded condition;

said expandable member dimensioned to be positioned within a target organ or blood vessel of the patient and constructed to permit blood and other body fluids to pass through the blood vessel or target organ while said expandable member is positioned therein; and

a bioabsorbable vessel plug operatively associated with said tubular member and said expandable member, said vessel plug dimensioned to obstruct the flow of fluids through the puncture or incision and said expandable member, when in said expanded condition within the blood vessel or the target organ, preventing said vessel plug from extending into the vessel or the target organ.

8. The apparatus of claim 7 wherein said vessel plug is a cylindrical rod shaped member constructed of a biodegradable material.

9. The apparatus of claim 7 further including an introducer having a lumen extending longitudinally therethrough, said introducer dimensioned to receive said tubular member and said expandable member within said lumen.

10. A method for sealing or closing an incision or puncture in the body of the living patient wherein the incision or puncture extends into a blood vessel of the patient, the method comprising:

inserting an elongated member into the incision, the elongated member being formed of a bioabsorbable material and having a distal end and a proximal end and having an expandable member disposed at the distal end, the expandable member constructed to be positioned alternatively in a relaxed condition and an expanded condition;

expanding the expandable member within the blood vessel and permitting blood to pass through the blood vessel while the expandable member is positioned therein;

positioning a surface of the expandable member adjacent the incision or puncture in the blood vessel; and

inserting a vessel plug into the incision or puncture proximally of the expandable member and the expandable member operating in the expanded condition to prevent the vessel plug from extending into the blood vessel of the patient.

11. The method of claim 10 wherein the insertion of an elongated member into the incision is accomplished by inserting the elongate member through a sheath introducer extending from the skin of the patient and into the blood vessel.

12. A method for sealing or closing an incision or puncture in the body of the living patient wherein the incision or puncture extends into a blood vessel or target organ of the patient, the method comprising:

inserting an elongated member into the incision, the elongated member being formed of a bioabsorbable material and having a distal end and a proximal end and having an expandable member disposed at the distal end, the expandable member constructed to be positioned alternatively in a relaxed condition and an expanded condition;

expanding the expandable member within the blood vessel or target organ and permitting blood or other body fluids to pass through the blood vessel or target organ while the expandable member is positioned therein;

positioning a surface of the expandable member adjacent the incision or puncture in the blood vessel or the target organ;

inserting a vessel plug into the incision or puncture proximally of the expandable member and the expandable member operating in the expanded condition to prevent the vessel plug from extending into the blood vessel or target organ of the patient; and

wherein the insertion of the vessel plug includes providing the plug as a cylindrical member made of a biodegradable material and inserting the plug in the incision or puncture to contact the surface of the expandable member adjacent to the incision.