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

• US 6,099,542 A
• Filed: 08/17/1998
• Issued: 08/08/2000
• Est. Priority Date: 03/15/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: BETH Israel Medical Center (Mount Sinai Beth Israel)
• Inventors: Cohn, William E., Kim, Ducksoo
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US09/134,995
• Time in Patent Office: 722 Days
• Field of Search: 606/167, 606/159, 606/153, 606/170, 606/171, 604/22, 128/899
• 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. An intervascular fistula generating catheter apparatus for percutaneous introduction through a perforation in a blood vessel wall, extension within a blood vessel in-vivo, and generation of a fistula on-demand between closely associated blood vessels at a chosen anatomic site in-vivo, said intervascular fistula generating catheter apparatus comprising:

a hollow sheath for percutaneous introduction through a perforation surgically created in a wall of a blood vessel in-vivo; and

a fistula generating vascular catheter suitable for percutaneous introduction through a perforation in a wall of a blood vessel via said hollow sheath and subsequent extension within a blood vessel in-vivo to a chosen anatomic site, said fistula generating vascular catheter being comprised of

(a) a vascular catheter tube suitable for entry through a vascular wall perforation and subsequent extension within a blood vessel in-vivo, said 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 tube tip adapted for entry through a perforation in a vascular wall and intravascular guidance of said vascular catheter tube within a blood vessel in-vivo to a chose anatomic site,

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

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

(e) remote activation means for activating said vascular wall perforation means of said vascular catheter tube on-demand wherein said vascular wall performation means perforates the vascular walls of the closely associated blood vessels at the chosen anatomic site to generate a fistula in-vivo between the closely associated blood vessels.

4. The intervascular fistula generating catheter apparatus as recited in claim 1, 2, or 3 wherein said magnet means comprises at least one rare earth magnet.

5. The intervascular fistula generating catheter apparatus as recited in claim 1, 2, or 3 wherein said magnet means comprises at least one electromagnet.

6. The intervascular fistula generating catheter apparatus as recited in claim 1, 2, or 3 wherein said vascular well perforation means is selected from the group consisting of radiofrequency electric circuitry means, static electricity discharge means, mechanical cutting means, and laser light energy carrying means.

2. An intervascular fistula generating catheter apparatus for percutaneous introduction through a perforation in a blood vessel wall, extension within a blood vessel in-vivo, and generation of a fistula on-demand between closely associated blood vessels at a chosen anatomic site in-vivo, said intervascular fistula generating catheter apparatus comprising:

a pair of hollow sheaths for individual percutaneous introduction through a performation surgically created in the walls of two different blood vessels in-vivo;

a pair of fistula generating vascular catheters suitable for individual percutaneous introduction through a perforation in a wall of a blood vessel via said hollow sheaths and subsequent extension individually within different blood vessels wherein at least one of said vascular catheters is comprised of

(a) a vascular catheter tube suitable for entry through a vascular wall perforation and subsequent extension within a blood vessel in-vivo, said 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 tube tip adapted for entry through a perforation in a vascular wall and intravascular guidance of said vascular catheter tube within a blood vessel in-vivo to a chosen anatomic site,

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

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

(e) remote activation means for activating said vascular wall perforation means of said vascular catheter tube on-demand wherein said vascular wall perforation means perforates the vascular walls of the closely associated blood vessels at the chosen anatomic site to generate a fistula in-vivo between the closely associated blood vessels; and

wherein the other of said fistula generating vascular catheter pair is comprised of

(a) a vascular catheter tube suitable for entry through a vascular wall perforation and subsequent extension within a blood vessel, said tube having a fixed axial length, a discrete proximal end, discrete distal end, and at least one internal lumen of predetermined volume, and

(b) a source of magnetic attraction positioned within said internal lumen of said vascular catheter tube.

3. An intervascular fistula generating catheter apparatus for percutaneous introduction through a perforation in a blood vessel, extension within a blood vessel in-vivo, and generation of a fistula on-demand between closely associated blood vessels at a chosen anatomic site in-vivo, said intervascular fistula generating catheter apparatus comprising:

a pair of hollow sheaths for individual percutaneous introduction through a perforation surgically created in the walls of two different blood vessels in-vivo;

a pair of fistula generating vascular catheters suitable for individual percutaneous introduction through a perforation in a wall of a blood vessel via said hollow sheaths and subsequent extension individually within different blood vessels comprising

a first vascular catheter comprised of

(a) a first vascular catheter tube suitable for entry through a vascular wall perforation and subsequent extension within a blood vessel in-vivo, said 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 first distal end tube tip adapted for entry through a perforation in a vascular wall and intravascular guidance of said first vascular catheter tube within a blood vessel in-vivo to a chosen anatomic site,

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

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

(e) remote activation means for activating said first component of vascular wall perforation means of said first vascular catheter tube on-demand in-vivo such that a fistula is generated between closely associated blood vessels at the chosen anatomic site; and

a second vascular catheter comprised of

(a) a second vascular catheter tube suitable for entry through a vascular wall perforation and subsequent extension within a blood vessel in-vivo, said 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 second distal end tube tip adapted for entry through a perforation in a vascular wall and intravascular guidance of said second vascular catheter tube within a blood vessel in-vivo to a chosen anatomic site,

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

(d) a second component of vascular wall perforation means positioned within said second vascular catheter tube at said second distal tube end adjacent to but separate from said second discrete magnet means and set in axial alignment with said second distal end tube tip, said second component of vascular wall perforation means becoming adjusted in position within the blood vessel via the magnetic force of said second magnetic means of said second vascular catheter tube and acting in concert with said first component of vascular wall perforation means to generate a fistula on-demand between closely associated blood vessels in-vivo at the chosen anatomic site.