Catheter apparatus and methodology for generating a fistula on-demand between closely associated blood vessels at a pre-chosen anatomic site in-vivo

• US 5,830,224 A
• Filed: 03/15/1996
• Issued: 11/03/1998
• Est. Priority Date: 03/15/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: BETH Israel Deaconess Medical Center (Caregroup Incorporated)
• Inventors: Cohn, William E., Kim, Ducksoo
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): RASCHE, PATRICK WILLIAM
• Application Number:
  US08/616,588
• Time in Patent Office: 963 Days
• Field of Search: 606/159, 606/167, 606/153, 606/170, 606/171, 604/22, 128/772
• US Class Current: 606/167
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/1139 Side-to-side connections, e.g. shunt or X-connections

Abstract

The present invention provides catheter apparatus and catheterization methodology for generating an arteriovenous fistula or a veno-venous fistula on-demand between closely associated blood vessels and at a chosen anatomic site in-vivo. The catheter apparatus is preferably employed in pairs, each catheter of the pair being suitable for percutaneous introduction into and extension through a blood vessel. The catheterization methodology employs the catheter apparatus preferably in conjunction with conventional radiological techniques in order to place, verify, and confirm a proper alignment, orientation, and positioning for the catheters in-vivo prior to activating the perforation means for generating a fistula. The invention permits the generation of arteriovenous fistulae and veno-venous fistulae anatomically anywhere in the vascular system of a patient; nevertheless, the invention is most desirably employed in the peripheral vascular system as exists in the extremities of the body to aid in the treatment of the patient under a variety of different medical ailments and pathologies.

Claims

1. A catheterization method for generating a fistula on-demand between closely associated blood vessels at a chosen anatomic site in-vivo, said catheterization method comprising the steps of:

procuring at least one catheter suitable for percutaneous introduction into and extension through a blood vessel in-vivo to a chosen anatomic site, said catheter being comprised of

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

(b) a distal end tip adapted for intravascular guidance of said tube through a blood vessel in-vivo to a chosen anatomic site,

(c) magnet means positioned at said discrete distal end and set in axial alignment with said distal end tip of said tube, said magnet means having sufficient magnetic force to cause an intravascular adjustment in position for said catheter when in proximity with a source of magnetic attraction disposed within a closely associated blood vessel in-vivo,

(d) vascular wall perforation means positioned at said discrete distal end adjacent to said magnet means and set in axial alignment with said distal end tip of said tube, said vascular wall perforation means becoming intravascularly adjusted in position via the magnetic force of said magnet means when in proximity with a source of magnetic attraction disposed within a closely associated blood vessel in-vivo,

(e) means for activating said vascular wall perforation means of said catheter on-demand wherein said vascular wall perforation means perforates a chosen anatomic site between closely associated blood vessels;

percutaneously introducing said catheter into a first blood vessel and extending said catheter intravascularly to a chosen site adjacent to a closely associated second blood vessel;

percutaneously introducing a source of magnetic attraction into a closely associated second blood vessel and extending said source of magnetic attraction intravascularly to a chosen anatomic site in proximity to said extended catheter;

permitting a transvascular magnetic attraction to occur between said magnet means of said extended catheter in the first blood vessel and said source of magnetic attraction in the closely associated second blood vessel whereby said vascular wall perforation means of said catheter in the first blood vessel comes into transvascular alignment with the closely associated second blood vessel at the chosen anatomic site; and

then

activating said vascular wall perforation means of said catheter on-demand wherein said vascular wall perforation means perforate of said catheter the vascular walls of said closely associated blood vessels concurrently at the chosen anatomic site to generate a fistula in-vivo.

2. A catheterization method for generating an arteriovenous fistula on-demand between a closely associated artery and vein at a chosen anatomic site in-vivo, said catheterization method comprising the steps of:

procuring a first catheter suitable for percutaneous introduction into and extension through a vein in-vivo to a chosen anatomic site, said first catheter being comprised of

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

(b) a distal end tip adapted for intravascular guidance of said first tube through a vein in-vivo to a chosen anatomic site,

(c) first magnet means positioned at said discrete distal end and set in axial alignment with said distal end tip of said first tube, said first magnet means having sufficient magnetic force to cause an intravascular adjustment in position for said first catheter when in proximity with a source of magnetic attraction in-vivo, and

(d) a first component of vascular wall perforation means positioned at said discrete distal end adjacent to said first magnet means and set in axial alignment with said distal end tip of said first tube, said first component of vascular wall perforation means becoming intravascularly adjusted in position via the magnetic force of said first magnetic means of said first catheter in-vivo,

(e) means for activating said first component of vascular wall perforation means of said first catheter on-demand wherein said vascular wall perforation means perforates a chosen anatomic site to generate a fistula in-vivo;

percutaneously introducing said first catheter into a vein and extending said first catheter intravascularly to a chosen anatomic site adjacent to a closely associated artery;

procuring a second catheter suitable for percutaneous introduction into and extension through an artery in-vivo to a chosen anatomic site, said second catheter being comprised of

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

(b) a distal end tip adapted for intravascular guidance of said second tube through an artery in-vivo to a chosen anatomic site,

(c) second magnet means positioned at said discrete distal end and set in axial alignment with said distal end tip of said second tube, said second magnet means having sufficient magnetic force to cause an intravascular adjustment in position for said second catheter when in proximity with said first magnetic means of said first catheter in-vivo,

(d) a second component of vascular wall abutment means positioned at said discrete distal end adjacent to said second magnet means and set in axial alignment with said distal end tip of said second tube, said second component of vascular wall perforation means becoming intravascularly adjusted in position via the magnetic force of said second magnet means of said second catheter in-vivo;

percutaneously introducing said second catheter into an artery and extending said second catheter intravascularly to a chosen anatomic site in proximity to said first catheter in to a closely associated vein;

permitting a transvascular magnetic attraction to occur between said first magnetic means of said extended first catheter in the vein and said second magnetic means of said extended second catheter in the closely associated artery whereby said first component of vascular wall perforation means of said first catheter lying within the vein comes into transvascular alignment with said second component of vascular wall abutment means of said second catheter lying within the artery; and

then

activating said first component of vascular wall perforation means of said first catheter on-demand wherein said vascular wall perforation means perforate the vascular walls of said vein and closely associated artery concurrently at the chosen anatomic site to generate an arteriovenous fistula in-vivo.