Catheter apparatus and method for creating a vascular bypass in-vivo

• US 5,676,670 A
• Filed: 06/14/1996
• Issued: 10/14/1997
• Est. Priority Date: 06/14/1996
• Status: Expired due to Term

• Current Assignee: BETH Israel Medical Center (Mount Sinai Beth Israel)
• 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:
  US08/664,165
• Time in Patent Office: 487 Days
• Field of Search: 606/108, 606/191, 606/192, 606/194, 606/195, 606/198, 606/159, 606/170, 606/167, 606/185, 606/184
• 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 vascular 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 previously excised vascular segment as a shunt. The invention allows the placement and creation of single or multiple vascular 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 vascular bypass on-demand between an unobstructed blood vessel and an obstructed blood vessel in-vivo using a previously excised vascular segment as a conduit, said vascular bypass catheter apparatus comprising:

a catheter suitable for introduction into and extension through the body in-vivo, said catheter being comprised of

(a) a hollow tube of fixed axial length having a proximal end, a distal end, and at least one internal lumen of predetermined diameter, and

(b) a distal end tip adapted for guidance of said catheter in-vivo to a chose site wherein an unobstructed blood vessel is in anatomic proximity to an obstruction lying within another blood vessel;

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) an expandable and contractible puncturing headpiece for puncture of and entry into the lumen of an unobstructed blood vessel, said puncturing headpiece being expandable on-demand to a size greater than the diameter of said internal lumen of said catheter and being contractible on-demand to a size less than the diameter of said internal lumen of said catheter,

(2) a perforating end tip on said puncturing headpiece to facilitate the perforation of a blood vessel wall at the chosen vascular 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 the previously excised vascular segment with said internal lumen of said catheter to the chosen site on the unobstructed blood vessel in-vivo,

(4) means for expanding and contracting said puncturing headpiece of said obturator on-demand; and

a deformable cuff for positioning over said elongated shaft adjacent to said puncturing headpiece of said obturator together with a previously excised vascular segment

(i) wherein, prior to the perforation of the unobstructed blood vessel in-vivo by said puncturing headpiece of said obturator, at least a portion of said deformable cuff has been engaged and joined to one end of the excised vascular segment then carried by said elongated shaft of said obturator,

(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 engaged cuff is extended into the lumen of the unobstructed blood vessel, is partially deformed in-situ by an expansion of said puncturing headpiece of said obturator, and said engaged cuff becomes attached via said partial deformation to the interior of the unobstructed blood vessel,

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

2. The catheter apparatus as recited in claim 1 wherein said deformable cuff is comprised of metal.

3. The catheter apparatus as recited in claim 1 wherein said deformable cuff is comprised of a polymeric material.

4. The catheter apparatus as recited in claim 1 wherein said deformable cuff is overlaid with prosthetic matter.

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

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

7. The catheter apparatus as recited in claim 1 wherein said means for expanding and contracting said puncturing headpiece further comprises a mechanical assembly.

8. The catheter apparatus as recited in claim 1 wherein said means for expanding and contracting said puncturing headpiece further comprises a hydraulic assembly.

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

providing a catheter suitable for introduction into and extension through the body in-vivo, said catheter being comprised of

(a) a hollow tube of fixed axial length having a proximal end, a distal end, and at least one internal lumen of predetermined diameter, and

(b) a distal end tip adapted for guidance of said catheter in-vivo to a chosen site wherein an unobstructed blood vessel is in anatomic proximity to an obstruction lying within another blood vessel;

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

(1) an expandable and contractible puncturing headpiece for puncture of and entry into the lumen of an unobstructed blood vessel, said puncturing headpiece being expandable on-demand to a size greater than the diameter of said internal lumen of said catheter and also being contractible on-demand to a size less than the diameter of said internal lumen of said catheter,

(2) a perforating end tip of 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 previously excised vascular segment with said internal lumen of said catheter to the chosen vascular site on the unobstructed blood vessel,

(4) means for expanding and contracting said puncturing headpiece of said obturator on-demand;

placing a previously excised vascular segment on the elongated shaft adjacent to said puncturing headpiece of said obturator;

positioning a deformable cuff over said elongated shaft and one end of the previously excised vascular segment lying adjacent to said puncturing headpiece of said obturator such that at least a portion of said deformable cuff engages and is joined to the end of the excised vascular segment;

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

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

partially deforming said extended cuff in-situ by an expansion of said puncturing headpiece of said obturator

(i) whereby said engaged cuff becomes attached via said partial deformation to the interior of the unobstructed blood vessel,

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

joining the other end of the secured vascular segment to the obstructed blood vessel at a chosen site distal to the obstruction, said joined segment serving as vascular conduit for 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 vascular bypass is created between an unobstructed artery and an obstructed artery.

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

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