Catheter apparatus having an improved shape-memory alloy cuff and inflatable on-demand balloon for creating a bypass graft in-vivo

• US 6,719,781 B1
• Filed: 12/24/1999
• Issued: 04/13/2004
• Est. Priority Date: 06/14/1996
• Status: Expired due to Fees

• Current Assignee: Aptus Medical Incorporated
• Original Assignee: Aptus Medical Incorporated
• Inventors: Kim, Ducksoo
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US09/472,711
• Time in Patent Office: 1,572 Days
• Field of Search: 606/108, 606/185, 606/195, 606/153, 606/155, 623/1.13, 623/1.14, 623/1.15, 623/1.19
• US Class Current: 623/1.13
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00292 mounted on or guided by flexible, e.g. catheter-like, means
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/30092 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/821 : Ostial stents
• CPC Class Codes: A61F 2002/8483 : Barbs
• CPC Class Codes: A61F 2002/8486 : provided on at least one of the ends
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0019 : operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2210/0023 : operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61M 2025/0233 : specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts

Abstract

The present invention provides a catheter apparatus, an improved introducer system, and a methodology for creating a bypass on-demand between an unobstructed blood vessel such as the aorta and an obstructed blood vessel such as an obstructed coronary artery in-vivo using a prepared shape-memory alloy cuff and a graft segment in tandem as a shunt. The invention allows the placement and creation of single or multiple bypass grafts without use of a heart-lung machine and without need for stopping the heart of the patient during the coronary artery bypass surgery.

Claims

1. A cuff connector for joining a tubular graft segment to a blood vessel in-vivo as a bypass conduit, said cuff connector comprising:

an unitary cuff portion comprised at least in part of thermoelastic material and prepared as an open meshwork in elongated extant dimensions and configuration for subsequent thermoelastic deformation on-demand into an outwardly flaired and permanently deformed shape, said unitary cuff portion being suitable for entry as an open meshwork in the elongated extant dimensions and configuration into the interior of a blood vessel, and wherein said on-demand thermoelastic deformation of said unitary cuff portion into an outwardly flared and permanently deformed shape within the interior of the blood vessel serves to secure the cuff connector to the blood vessel and places the cuff connector in fluid flow communication with the interior of the blood vessel; and

a conduit connector portion of elongated extant dimensions and configuration which does not thermoelastically deform and which substantially retains its elongated extant dimensions and configuration despite said unitary cuff portion becoming thermoelastically deformed on-demand into a an outwardly flaired and permanently deformed shape, said conduit connector portion being configured for connection to and permanent juncture with a tubular graft segment such that said juncture with the tubular graft segment serves to secure the tubular graft segment to the cuff connector and places the cuff connector in fluid flow communication with the tubular graft segment.

3. The cuff connector as recited in claim 1 or 2 wherein said cuff connector comprises a shape-memory alloy.

4. The cuff connector as recited in claim 1 or 2 wherein said cuff connector is dimensioned and configured at least in part as a cylindrical structure.

2. A cuff connector for joining a tubular graft segment to a blood vessel in-vivo as a bypass conduit, said cuff connector comprising:

a first unitary cuff end portion comprised at least in part of thermoelastic material and prepared as an open meshwork in elongated extant dimensions and configuration for subsequent thermoelastic deformation on-demand into an outwardly flaired and permanently deformable shape, said first unitary cuff end portion being suitable for entry as an open meshwork in the elongated extant dimensions and configuration into the interior of a blood vessel, and wherein said on-demand thermoelastic deformation of said first unitary cuff end portion into an outwardly flaired and permanently deformed shape within the interior of the blood vessel serves to secure the cuff connector to the blood vessel and places the cuff connector in fluid flow communication with the interior of the blood vessel;

a second unitary cuff end portion comprised at least in part of thermoelastic material and prepared as an open meshwork in elongated extant dimensions and configuration for subsequent thermoelastic deformation on-demand into an outwardly flaired and permanently deformed shape, said second unitary cuff end portion being suitable for positioning adjacent an exterior surface of a blood vessel, and wherein said on-demand thermoelastic deformation of said posterior cuff end portion into an outwardly flaired and permanently deformed shape adjacent the exterior surface of the blood vessel serves to secure the cuff connector to the exterior surface of the blood vessel; and

a medial conduit connector portion of determined dimensions and configuration which does not thermoelastically deform and which substantially retains its dimensions and configuration despite said first and second unitary cuff end portions becoming thermoelastically deformed on-demand into outwardly flaired and permanently deformed shapes, said medial conduit connector portion being configured for connection to and permanent juncture with a tubular graft segment such that said juncture with the tubular graft segment serves to secure the tubular graft segment to the cuff connector and places the cuff connector in fluid flow communication with the tubular graft segment.

5. A cuff conduit useful as a bypass graft for a blood vessel in-vivo, said cuff conduit comprising:

a cuff connector comprised of

an unitary cuff portion comprised at least in part of thermoelastic material and prepared as an open meshwork in elongated extant dimensions and configuration for subsequent thermoelastic deformation on-demand into an outwardly flaired and permanently deformed shape, said unitary cuff portion being suitable for entry as an open meshwork in the elongated extant dimensions and configuration into the interior of a blood vessel, and wherein said on-demand thermoelastic deformation of said unitary cuff portion into an outwardly flaired and permanently deformed shape within the interior of the blood vessel serves to secure the cuff connector to the blood vessel and places the cuff connector in fluid flow communication with the interior of the blood vessel, and

a conduit connector portion of elongated extant dimensions and configuration which does not thermoelastically deform and which substantially retains its elongated extant dimensions and configuration despite said unitary cuff portion becoming thermoelastically deformed on-demand into an outwardly flaired and permanently deformed shape, said conduit connector portion being configured for connection to and permanent juncture with a tubular segment such that said juncture with the tubular segment serves to secure the tubular segment to the cuff connector and places the cuff connector in fluid flow communication with the tubular segment; and

a tubular segment having at least two ends and at least one internal lumen wherein one of said ends is permanently joined to said connector portion of said cuff connector and is in fluid flow communication with said cuff connector.

6. The cuff conduit as recited in claim 5 wherein said cuff conduit is a unitary one-piece structure.

7. The cuff conduit as recited in claim 5 wherein said tubular segment comprises an excised blood vessel segment.

8. The cuff conduit as recited in claim 5 wherein said tubular segment comprises a synthetic prosthesis section.