Catheter apparatus and method using a shape-memory alloy cuff for creating a bypass graft in-vivo

• US 5,797,920 A
• Filed: 08/23/1996
• Issued: 08/25/1998
• Est. Priority Date: 06/14/1996
• Status: Expired due to Term

• Current Assignee: BETH Israel Deaconess Medical Center (Caregroup Incorporated)
• Original Assignee: BETH Israel Deaconess Medical Center (Caregroup Incorporated)
• Inventors: Kim, Ducksoo
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): YU, JUSTINE ROMANG
• Application Number:
  US08/702,068
• Time in Patent Office: 732 Days
• Field of Search: 606/108, 606/159, 606/184, 606/185, 606/192, 606/198, 606/195, 604/164, 604/161, 623/1, 623/12
• US Class Current: 606/108
• 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 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections
• 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 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/821 Ostial stents
• 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 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 shaped 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 catheter apparatus for creating a bypass on-demand between an unobstructed blood vessel and an obstructed blood vessel in-vivo using a graft segment as a conduit, said bypass catheter apparatus comprising:

a catheter suitable for introduction into and extension through the body in-vivo to a chosen site wherein an unobstructed blood vessel is in anatomic proximity to an obstruction lying within another blood vessel, said catheter being comprised of a hollow tube of fixed axial length having a proximal end, a distal end, and at least one internal lumen of predetermined diameter;

an obturator for on-demand introduction and passage through said catheter to a chosen site on the unobstructed blood vessel in-vivo, said obturator comprising

(1) a puncturing headpiece for puncture of and entry into the lumen of an unobstructed blood vessel,

(2) a perforating end tip on said puncturing headpiece to facilitate the perforation of a blood vessel wall at the chosen site in-vivo,

(3) an elongated shaft of fixed axial length integrated with said puncturing headpiece, said elongated shaft being configured for the carrying and transport of a graft segment within said internal lumen of said catheter to the chosen site on the unobstructed blood vessel in-vivo; and

a thermoelastic deformable cuff comprised of a prepared shape-memory allow for positioning over said elongated shaft adjacent to said puncturing headpiece of said obturator together with a graft segment

(i) wherein, prior to the perforation of the unobstructed blood vessel in-vivo by said puncturing headpiece of said obturator, a portion of said cuff in a first shaped configuration has been engaged and joined to one end of the graft segment then carried by said elongated shaft of said obturator thereby forming an engaged cuff portion and a non-engaged cuff portion,

(ii) and wherein, after the perforation of the unobstructed blood vessel in-vivo by said puncturing headpiece of said obturator, at least part of said non-engaged cuff portion is extended into the lumen of the unobstructed blood vessel and becomes thermoelastically deformed in-situ into a prepared memory-shaped second configuration, and said prepared memory-shaped second configuration of said deformed non-engaged cuff portion becomes disposed onto an interior surface of the unobstructed blood vessel,

(iii) and whereby said cuff engaged end of the graft segment become secured to and placed in blood flow communication with the unobstructed blood vessel and serves as a conduit means for bypassing an obstruction and restoring blood flow from the unobstructed blood vessel to the obstructed blood vessel to the obstructed blood vessel.

2. The catheter apparatus as recited in claim 1 wherein said thermally deformable cuff is comprised of a nickel-titanium alloy.

3. The catheter apparatus as recited in claim 1 wherein said thermally deformable cuff is overlaid with a biocompatible coating.

4. The catheter apparatus as recited in claim 1 wherein said thermally deformable cuff comprises an open meshwork.

5. The catheter apparatus as recited in claim 1 wherein said thermally deformable cuff comprises a solid mass of material.

6. The catheter apparatus as recited in claim 1 wherein said obturator further comprises means for expansion and contraction of said puncturing headpiece on-demand.

7. The catheter apparatus as recited in claim 1 wherein said graft segment comprises a synthetic prosthetic channel section.

8. The catheter apparatus as recited in claim 1 wherein said graft segment comprises a previously excised blood vessel segment.

9. A catheterization method for creating a bypass on-demand between an unobstructed blood vessel and an obstructed blood vessel in-vivo using a graft segment as a conduit, said bypass catheterization method comprising the steps of:

providing a catheter suitable for introduction into and extension through the body in-vivo to a chosen site wherein an unobstructed blood vessel is in anatomic proximity to an obstruction lying within another blood vessel, said catheter being comprises of a hollow tube of fixed axial length having a proximal end, a distal end, and at least one internal lumen of predetermined diameters;

providing an obturator for on-demand introduction and passage through said catheter to a chosen site on the unobstructed blood vessel in-vivo, said obturator comprising

(1) a puncturing headpiece for puncture of and entry into the lumen of an unobstructed blood vessel,

(2) a perforating end tip on said puncturing headpiece to facilitate the perforation of a blood vessel wall at the chosen site in-vivo, and

(3) an elongated shaft of fixed axial length integrated with said puncturing headpiece, said elongated shaft being configured for the carrying and transport of a graft segment within said internal lumen of said catheter to the chosen vascular site on the unobstructed blood vessel;

placing a graft segment on the elongated shaft adjacent to said puncturing headpiece of said obturator;

positioning a thermoelastic determable cuff comprised of a prepared shape-memory alloy for positioning over said elongated shaft and an end of said graft segment lying adjacent to said puncturing headpiece of said obturator such that at least a portion of said cuff in a first configuration engages and is joined to one end of said graft segment thereby forming an engaged cuff portion and a non-engaged cuff portion;

perforating the unobstructed blood vessel at the chosen site in-vivo using said puncturing headpiece of said obturator;

extending at least part of said non-engaged cuff portion into the lumen of the unobstructed blood vessel;

allowing said extended non-engaged cuff portion to deform thermoelastically in-situ into a prepared memory-shaped second configuration within the lumen of the unobstructed blood vessel,

(i) whereby said prepared memory-shaped second configuration of said deformed non-engaged cuff portion becomes disposed onto an interior surface of the unobstructed blood vessel,

(ii) and whereby said cuff engaged end of said graft segment become secured to and placed in blood flow communication with the unobstructed blood vessel; and

joining the other end of said secured graft segment to the obstructed blood vessel at a chosen site distal to the obstruction, said joined graft serving as means for bypassing the obstruction and restoring blood flow from the unobstructed blood vessel to the obstructed blood vessel.

10. The catheterization method as recited in claim 9 wherein the bypass conduit is created between an unobstructed artery and an obstructed artery.

11. The catheterization method as recited in claim 9 wherein the bypass conduit is created between an unobstructed vein and an obstructed vein.

12. The catheterization method as recited in claim 9 wherein the bypass conduit is created between an artery and a vein.