Apparatus and method for retaining a catheter in a blood vessel in a fixed position

• US 6,071,263 A
• Filed: 06/07/1995
• Issued: 06/06/2000
• Est. Priority Date: 03/02/1992
• Status: Expired due to Fees

• Current Assignee: Kirkman, Thomas R.
• Original Assignee: Kirkman, Thomas R.
• Inventors: Kirkman, Thomas R.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/473,129
• Time in Patent Office: 1,826 Days
• Field of Search: 604/104-107, 604/280, 604/282, 604/160, 604/174, 604/175, 606/198-200, 606/108, 606/191
• US Class Current: 604/104
• CPC Class Codes: A61B 2017/3484 Anchoring means, e.g. spreading-out umbrella-like structure
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A method and apparatus for retaining a catheter tip in a fixed position within a blood flow and preventing it from contacting a blood vessel wall. The apparatus includes a tip retainer at the distal end of the catheter that anchors the tip of the catheter within the blood vessel. The catheter tip is retained within the blood vessel spaced from the wall to ensure that it does not contact the wall of the blood vessel. This reduces damage to the blood vessel caused by chronic movement and contact between the catheter tip and the wall of the blood vessel. In one embodiment, the tip retainer includes a prong that penetrates the wall of the blood vessel, thus preventing the catheter tip from moving longitudinally within the blood vessel. In alternative embodiments, the tip retainer contacts the wall but does not penetrate the wall.

Claims

1. A catheter adapted for insertion into a blood vessel having blood flowing therethrough, comprising:

a catheter having a distal end, a proximal end, a tip and an internal passageway for permitting fluids to pass through the catheter; and

a tip immobilizing means located at the distal end of the catheter for anchoring the distal end of the catheter within the blood flow to maintain the tip of the catheter in a spaced relationship from a blood vessel wall and to prevent the tip of the catheter from contacting a wall of the blood vessel without substantially obstructing fluid flow of blood through the blood vessel, such that catheter failure due to stenosis or thrombosis at the catheter distal end if reduced.

2. A catheter adapted for insertion into a blood vessel comprising:

a catheter having a lumen therein that permits fluids to pass through said catheter, the catheter having a tip portion and a proximal portion spaced form the tip portion;

a tip retainer assembly attached to the tip portion of the catheter; and

a plurality of wall contact members, each of which contacts a blood vessel wall when the catheter is within a blood vessel, the wall contact members being a part of the tip retainer assembly, the wall contact members including a wall contact portion for contacting the blood vessel wall at a selected location and remaining in contact with the blood vessel wall for an extended time, the wall contact members being attached to said catheter tip portion and maintaining the catheter tip a spaced distance from the blood vessel wall and preventing the catheter tip from contacting the blood vessel to prevent damage to the blood vessel wall by repeated contact between the catheter tip and the blood vessel wall.

3. The catheter according to claim 2 wherein each of said wall contact members is spring biased with a selected spring force for extending into abutting contact with said blood vessel wall, each of said wall contact members being spaced from each other circumferentially around the catheter tip portion to provide a tip retainer assembly that resiliently biases the catheter tip a fixed distance spaced from said blood vessel wall and maintains the catheter tip within the blood flow region.

4. The catheter according to claim 2 wherein said wall contact portion contacts said wall at a position adjacent the tip of said catheter tip.

5. The catheter according to claim 2 wherein said wall contact members are spring biased for permitting the tip portion to move within the blood vessel for providing a spring bias force that prevents repeated contact between the tip portion and the blood vessel wall to prevent damage to the blood vessel wall.

6. The catheter according to claim 5 wherein the wall contact members exert a light spring force for centering the tip portion within the blood vessel wall when the tip portion is approximately in the center of the blood vessel and exerts a gradually increasing spring bias force as the tip portion becomes closer to the wall, increasing the force with which the catheter tip portion is held away from the wall as the tip portion comes closer to the wall, the light spring force permitting relative movement of the catheter tip, and the gradually increasing spring force making it more difficult for the catheter tip to actually contact the wall.

7. An assembly adapted for insertion into a blood vessel comprising:

a catheter means for introduction into a blood vessel, the catheter means being adapted to being positioned within the blood vessel, the catheter means having a tip portion;

an introducer assembly means for aid in inserting the said catheter means into a blood vessel; and

a tip retainer assembly means located at the distal end of the catheter for retaining the tip portion in a relatively fixed position within a blood vessel, the tip retainer assembly means being adapted to be in a retracted position when the catheter means is not positioned within the blood vessel and in a deployed position when the catheter means is within the blood vessel, the tip retainer assembly means retaining the tip portion of the catheter means in a spaced position from the blood vessel wall and preventing repeated contact of the tip portion of the catheter means with the blood vessel wall.

8. The assembly according to claim 7 wherein the introducer assembly includes a means for holding the blood vessel open to facilitate positioning of the catheter means at a desired location in the blood vessel.

9. The assembly according to claim 8 wherein said means for holding the blood vessel open includes an introducer sheath means for enclosing the catheter means and for holding the blood vessel open.

10. The assembly according to claim 9 wherein said introducer sheath means includes an introducer sheath removal means for permitting easy removal of the introducer sheath from the catheter means.

11. The assembly according to claim 10 wherein the introducer sheath removal means includes a tearable membrane which forms a tubular portion of the introducer sheath for enclosing the catheter means and gripping means for gripping the introducer sheath, while tearing the introducer sheath to the introducer sheath from the catheter means.

12. The assembly according to claim 7 wherein said tip retainer assembly means includes a spring means for permitting the tip portion to move a limited distance within the blood vessel but for providing a spring bias force that prevents repeated contact between the tip portion and the blood vessel wall to prevent damage to the blood vessel wall.

13. The assembly according to claim 12 wherein the spring force provided by the spring means increases in strength as the tip portion becomes closer to the blood vessel wall, thus serving to maintain a spaced relationship between the blood vessel wall and the tip portion.

14. The assembly according to claim 12 wherein the spring means exerts a light spring force for centering the tip portion within the blood vessel wall and exerts a gradually increasing spring force as the tip portion becomes closer to one wall, increasing the force with which the catheter tip portion is held away from the wall as the tip portion comes closer to the wall, the light spring force permitting some relative movement of the catheter tip, and the gradually increasing spring force making it more difficult for the catheter tip to actually contact the wall.

15. A method of inserting a catheter having a tip retainer assembly attached at one end thereof into a blood vessel, comprising:

placing a sheath insertion tube assembly within a blood vessel, the sheath insertion tube assembly including an insertion sheath having handles at a proximal end thereof which are not inserted into the blood vessel, a tip portion which is inserted into a blood vessel and a catheter within the insertion sheath, said catheter having a tip retainer assembly at a distal end of said catheter;

maneuvering the insertion sheath assembly with the catheter therein to a selected position within the blood vessel; and

withdrawing the insertion sheath from the catheter tube while maintaining the catheter tube at a fixed position within the blood vessel, the withdrawal of the insertion sheath causing the tip retainer assembly to be deployed in a spaced position away from the catheter tube such that the tip retainer assembly contacts the blood vessel wall with a preselected resilient spring biased force and maintains the catheter tip anchored at a preselected location and held a selected distance from the blood vessel wall to prevent the catheter tip from contacting the blood vessel wall.

16. The method according to claim 15 wherein said tip retainer assembly includes a plurality of wires, the method further including:

selectively extending or retracting said plurality of wires at a distal region of the tip retainer to ensure that the tip retainer assembly contacts the blood vessel wall with sufficient force to retain the tip spaced from the wall but not with excessive force such as to significantly distort the blood vessel wall shape or penetrate through the wall.

17. The method of securing a catheter tip at a selected location in a blood vessel, comprising:

inserting a catheter within a blood vessel, the catheter having a tip and a tip retainer assembly adjacent the tip in a retracted position, the tip retainer assembly having a distal end in a retracted position and including a control assembly at a proximal end of the catheter outside the blood vessel;

maneuvering the catheter tip to a selected location within the blood vessel; and

manipulating the control assembly of the tip retainer to deploy the tip retainer assembly into abutting contact with the blood vessel wall such that the tip retainer assembly contacts the blood vessel wall with sufficient force to maintain the catheter tip anchored at a preselected location and holds the catheter tip in a spaced relationship from the blood vessel wall to prevent the catheter tip from repeatedly contacting the blood vessel wall.