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

• US 6,007,544 A
• Filed: 04/16/1998
• Issued: 12/28/1999
• 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): Apley, Richard J.
• Assistant Examiner(s): YU, JUSTINE ROMANG
• Application Number:
  US09/060,958
• Time in Patent Office: 621 Days
• Field of Search: 606/108, 606/195, 606/198, 606/191, 606/192, 606/185, 606/194, 604/93, 604/96, 604/164, 623/1, 623/11, 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 2017/00867 shape memory effect
• 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 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 catheter apparatus for creating a bypass on-demand between an unobstructed blood vessel and an obstructed blood vessel in-vivo using a graft segment of predeterminable internal diameter as a conduit, said bypass catheter apparatus comprising:

a cathether 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

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

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

(c) 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 at least one 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 alloy in a chosen extant configuration for positioning over said elongated shaft adjacent to said puncturing headpiece of said obturator with a graft segment of predeterminable internal diameter, said thermoplastic cuff having a central portion and two end portions

(i) wherein, prior to the perforation of the unobstructed blood vessel in-vivo by said puncturing headpiece of said obturator, said central portion of said cuff 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 central cuff portion and two non-engaged cuff end portions,

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

(iii) and wherein, after perforation of the unobstructed blood vessel in-vivo by said puncturing headpiece of said obturator, the other of said non-engaged cuff end portions is positioned adjacent an exterior surface of the unobstructed blood vessel, and becomes thermoelastically deformed in-situ adjacent the exterior surface of the unobstructed blood vessel into a second prepared memory-shaped end configuration, and is disposed in the second prepared memory-shaped end configuration onto an exterior surface of the unobstructed blood vessel,

(iv) and whereby the end of the graft segment engaged by the central portion of the cuff becomes secured to and placed in blood flow communication with the unobstructed blood vessel and serves as conduit means for bypassing an obstruction and restoring blood flow from the unobstructed blood vessel to an obstructed blood vessel.

4. The catheter apparatus as recited in claim 1, 2, or 3 wherein said deformable cuff is comprised of a nickel-titanium alloy.

5. The catheter apparatus as recited in claim 1, 2, or 3 wherein said deformable cuff is overlaid with a biocompatible coating.

6. The catheter apparatus as recited in claim 1, 2, or 3 wherein said deformable cuff comprises an open meshwork.

7. The catheter apparatus as recited in claim 1, 2, or 3 wherein said deformable cuff comprises a solid mass of material.

8. The catheter apparatus as recited in claim 1, 2, or 3 wherein said obturator further comprises means for expansion and contraction of said puncturing headpiece on-demand.

9. The catheter apparatus as recited in claim 1, 2, or 3 wherein said graft segment comprises a synthetic prosthetic channel section.

10. The catheter apparatus as recited in claim 1, 2, or 3 wherein said graft segment comprises a previously excised blood vessel segment.

2. 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 of predeterminable internal diameter as a conduit, said bypass catheter apparatus comprising:

a cathether 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

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

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

(c) 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 of predeterminable internal diameter within said at least one internal lumen of said catheter to the chosen site on the unobstructed blood vessel in-vivo;

an inflatable and deflatable on-demand balloon of prechosen girth and configuration disposed adjacent to said puncturing headpiece on said elongated shaft of said obturator, the girth of said balloon in the deflated state being less than the internal diameter of the graft segment to be used as a conduit; and

a thermoelastic deformable cuff comprised of a prepared shape-memory alloy in a chosen extant configuration for positioning over said elongated shaft adjacent to said puncturing headpiece of said obturator with a graft segment of predeterminable internal diameter, said thermoplastic cuff having a central portion and two end portions

(i) wherein, prior to the perforation of the unobstructed blood vessel in-vivo by said puncturing headpiece of said obturator, said central portion of said cuff 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 central cuff portion and two non-engaged cuff end portions,

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

(iii) and wherein, after perforation of the unobstructed blood vessel in-vivo by said puncturing headpiece of said obturator, the other of said non-engaged cuff end portions is positioned adjacent an exterior surface of the unobstructed blood vessel, and becomes thermoelastically deformed in-situ adjacent the exterior surface of the unobstructed blood vessel into a second prepared memory-shaped end configuration, and is disposed in the second prepared memory-shaped end configuration onto an exterior surface of the unobstructed blood vessel,

(iv) and whereby the end of the graft segment engaged by the central portion of the cuff becomes secured to and placed in blood flow communication with the unobstructed blood vessel and serves as conduit means for bypassing an obstruction and restoring blood flow from the unobstructed blood vessel to an obstructed blood vessel.

11. The catheter apparatus as recited in claim 2 or 3 wherein said balloon comprises means for conveying fluid.

12. The catheter apparatus as recited in claim 2 or 3 wherein said balloon comprises an enclosing sheath.

13. The catheter apparatus as recited in claim 2 or 3 wherein said balloon is composed of at least one material selected from the group consisting of elastic and non-elastic substances.

3. 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 of predeterminable internal diameter as a conduit, said bypass catheter apparatus comprising:

a cathether 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

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

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

(c) 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 of predeterminable internal diameter within said at least one internal lumen of said catheter to the chosen site on the unobstructed blood vessel in-vivo;

an inflatable and deflatable on-demand balloon of prechosen girth and configuration disposed adjacent to said puncturing headpiece on said elongated shaft of said obturator, the girth of said balloon in the deflated state being less than the internal diameter of the graft segment to be used as a conduit; and

a thermoelastic deformable cuff comprised of a prepared shape-memory alloy in a chosen extant configuration for positioning over said elongated shaft adjacent to said puncturing headpiece of said obturator with a graft segment of predeterminable internal diameter

(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 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 two non-engaged cuff end portions,

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

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