Apparatus and method for engrafting a blood vessel

• US 5,591,195 A
• Filed: 10/30/1995
• Issued: 01/07/1997
• Est. Priority Date: 10/30/1995
• Status: Expired due to Term

• Current Assignee: World Medical Manufacturing Corp. (Medtronic Plc)
• Original Assignee: Howard J. Leonhardt, Syde Taheri
• Inventors: Taheri, Syde, Leonhardt, Howard J.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/549,880
• Time in Patent Office: 435 Days
• Field of Search: 606/192, 606/193, 606/194, 606/195, 606/197, 606/198, 623/1, 623/12, 604/96, 604/104
• US Class Current: 623/1.11
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• 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 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/09183 having tools at the distal tip
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 2210/127 : Aorta
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/10184 : Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A method and apparatus for engrafting a blood vessel is disclosed. The apparatus includes a hollow tubular graft of a preselected cross section having a proximal and distal end containing compressable and expandable nitinol springs, and connecting bars to facilitate physical communication between both springs. Furthermore, the apparatus contains a transport and deployment member for delivering said hollow tublar graft to an engrafting site within a blood vessel. The transport and deployment apparatus is comprised of an insertion catheter having a graft balloon and a tip balloon, as well as multiple inner tracks for injection of fluid into said balloons and the blood vessel interior. The method includes transport and deployment of said graft, as well as non surgical movement and removal of said graft in the event of misplacement.

Claims

1. An apparatus for engrafting a blood vessel comprising:

a hollow tubular graft of a preselected cross section having a proximal end, a distal end, and a middle portion; and

said hollow tubular graft being capable of substantially deforming so as to conform to an interior surface of said blood vessel;

a compressible and expandable proximal spring perpendicularly located at said proximal end of said hollow tubular graft, and said proximal spring being capable of deforming so as to conform to

the interior surface of said blood vessel;

said proximal spring containing sufficient outward force to exert continuous force against

and inner wall of said blood vessel;

said proximal spring being comprised of nitinol;

a compressible and expandable distal spring perpendicularly

located at said distal end of said hollow tubular graft, and said distal spring being capable of deforming so as to conform to the interior surface of said blood vessel;

said distal spring containing sufficient outward force to exert continuous force against the inner wall of said blood vessel;

said distal spring being comprised of nitinol;

at least one flexible connecting bars for maintaining physical communication between said proximal and distal springs;

said at least one connecting bars being comprised of nitinol;

a graft material;

said graft material encasing said proximal spring, said distal spring, and said at least one connecting bars;

said graft material being distensible at said distal and said proximal ends to facilitate expansion of said proximal and distal springs.

2. An apparatus according to claim 1 further comprising:

a transport and deployment means for delivering said hollow tubular graft to an engrafting site of said blood vessel.

3. An apparatus according to claim 1 wherein said force exerted against the inner wall of said blood vessel by said proximal and distal nitinol springs is sufficient to prevent blood flow between said hollow tubular graft and the inner wall of said blood vessel.

4. An apparatus according to claim 1 wherein said force exerted against the inner wall of said blood vessel by said proximal and distal nitinol springs is between 240 grams and 340 grams.

5. An apparatus according to claim 1 wherein middle portion of said graft contains a smaller diameter than said distal and said proximal ends.

6. An apparatus according to claim 1 wherein said middle portion of said graft material is non-distensible.

7. An apparatus according to claim 1 further comprising a first nitinol mesh extension connected to said proximal nitinol spring;

and a second nitinol mesh extension connected to said distal nitinol spring.

8. An apparatus according to claim 1 wherein said graft further comprises:

one or more outer v-shaped portions of said proximal nitinol spring, one or more strings having a first and second end;

said one or more strings movably connected to said one or more outer v-shaped portions of said proximal nitinol spring.

9. An apparatus according to claim 2 wherein said transport and deployment means comprises:

an insertion catheter having a length, a proximal end, a distal end, and one or more inner tracks;

a first inner track having an opening at both said proximal and said distal ends;

a second inner track having an opening at said proximal end and being closed at said distal end;

a nitinol core wire embedded in and along said length of said insertion catheter;

a controllable inflatable and deflatable graft balloon disposed about and integral with said insertion catheter;

a third inner track having a first opening at said proximal end and a second opening into said controllable inflatable and deflatable graft balloon;

a controllable inflatable and deflatable tip balloon disposed about and integral with said distal end of said insertion catheter;

a fourth inner track having a first opening at said proximal end of said insertion catheter and a second opening into said controllable inflatable and deflatable tip balloon;

a means for inflating and deflating said controllable inflatable and deflatable graft balloon and tip balloon; and

a sheath introducer.

10. A method for engrafting a blood vessel comprising the steps of:

a. providing a sizing means for sizing a diameter of said blood vessel and the length of a rupture;

b. sizing said diameter of said blood vessel and length of said rupture with said sizing means;

c. pre-loading an insertion catheter having a tip balloon, a graft balloon, and at least one inner track within a graft having a distal and proximal end;

positioning said insertion catheter with said tip balloon extending outward from said distal end of said graft;

d. pre-loading said graft and said insertion catheter within a sheath introducer;

e. providing a means for inflating and deflating said tip balloon;

f. inflating said tip balloon;

g. inserting said sheath introducer into said blood vessel;

h. moving said sheath introducer through said blood vessel to said rupture;

i. providing a means for verifying position of said graft;

j. verifying said position of said graft;

k. providing a means for inflating and deflating said graft balloon;

l. providing a push rod;

m. inserting said push rod into one of said one or more inner tracks of said insertion catheter;

n. providing a means for reducing a mean arterial and pulmonary artery venous blood pressure and subsequently returning said mean arterial pressure and pulmonary artery venous blood pressure to a normal pressure;

o. reducing said mean arterial and pulmonary artery venous blood pressure to said normal pressure;

p. inflating said graft balloon while applying inward force to said push rod and pulling back said sheath introducer until both said proximal and distal nitinol springs are released from said sheath introducer;

q. returning said mean arterial pressure and pulmonary artery venous blood pressure to said normal pressure;

r. slowly deflating said graft balloon;

s. removing said insertion catheter from said blood vessel.

11. A method according to claim 10 wherein said means for reducing a mean arterial and pulmonary artery venous blood pressure and subsequently returning said mean arterial and pulmonary artery venous blood pressure to a normal pressure is a double balloon blocking catheter.

12. A method according to claim 10 wherein said means for reducing a mean arterial and pulmonary artery venous blood pressure and subsequently returning said mean arterial and pulmonary artery venous blood pressure to a normal pressure are two single balloon blocking catheters.

13. A method according to claim 10 wherein said means for verifying the

position of said graft is injecting contrast media into a blood vessel lumen.

14. A method according to claim 10 wherein said means for inflating and

deflating said graft balloon is a syringe.