Lined infusion catheter

• US 5,702,372 A
• Filed: 02/08/1995
• Issued: 12/30/1997
• Est. Priority Date: 02/08/1995
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Nelson, Timothy S.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/385,498
• Time in Patent Office: 1,056 Days
• Field of Search: 604/265, 604/280, 604/131, 604/151, 604/283, 604/282, 604/284
• US Class Current: 604/264
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0048 with an outer layer made from silicon
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: C08L 23/06 Polyethene
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 53/02 of vinyl-aromatic monomers and conjugated dienes
• CPC Class Codes: C08L 75/02 Polyureas
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 75/08 from polyethers
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

An infusion catheter for delivering drugs or other agents to selected sites in an organism, such as a human. In an alternate embodiment, a catheter system is disclosed having an infusion catheter and a pump that may be implanted or disposed outside the organism. In either embodiment, the free end of the catheter bears a rounded tip that has at least one elution hole for discharging an agent or drug to a selected site. The catheter has a tubular inner liner that is integral with the tip. The inner liner and tip are formed from a drug compatible polymeric material that is relatively nonporous and unreactive with the agent to be infused. A biocompatible flexible elastomeric tubular jacket surrounds the inner liner and a portion of the tip excluding that portion containing the elution hole or holes. Since the agent flowing in the catheter is isolated from the jacket while flowing through the catheter, and since the inner liner is relatively nonporous and unreactive with the agent to be infused, the agent is prevented from diffusing out of the catheter, adsorbing to the surface of the biocompatible jacket, reacting adversely with the jacket material or becoming exposed to substances diffusing through the jacket.

Claims

1. A catheter for delivering, to a selected site within an organism, agents, drugs or other fluids that exhibit some detrimental sensitivity to material used to make the catheter or that may diffuse through material used to make the catheter, the catheter comprising:

a jacket having a proximal and a distal end;

an inner liner forming a lumen, the inner liner having a proximal end and a distal end, the inner liner disposed inside the jacket and made of a material that is non-reactive with the agent, drug or fluid to be delivered through the inner liner, the proximal end of the inner liner adapted to be in fluid communication with a source of fluid;

a tip, attached to the distal end of and in fluid communication with the lumen of the inner liner, the tip made of the same material as the inner liner, the tip extending distally beyond the distal end of the jacket, the tip having at least one orifice for delivering fluid from the lumen of the inner liner to outside the catheter at the distal end of the catheter through the orifice;

a radiographic marker attached to the distal end of the catheter, the radiographic marker comprising a semispherical portion with a cylindrical nipple emanating away therefrom, the cylindrical nipple being sized to fit snugly within the lumen and held in place by a biocompatible adhesive, the radiographic marker being made of a material opaque to x-rays;

whereby the jacket is isolated from fluid flowing in lumen, and

whereby the fluid flowing through the lumen contacts only the material of the inner tubular lumen and tip as the fluid flows through the lumen and out the orifice.

2. The catheter of claim 1 wherein the jacket is made of a material that an agent, drug or other fluid to be delivered to a selected site within an organism exhibits detrimental sensitivity to.

3. The catheter of claim 1 wherein the jacket is made of a material that an agent, drug or other fluid to be delivered to a selected site within an organism may diffuse through.

4. The catheter of claim 1 wherein the jacket is made of a material that may allow a fluid to diffuse through the jacket from outside the catheter and affect an agent, drug or other fluid being delivered to a selected site within an organism.

6. The catheter system of claim 1 wherein the jacket is made of a material selected from the group consisting of silicone, barium loaded silicone, polyurethane, polyether urethane, polyether urethane urea and styrene butadiene rubber.

7. The catheter of claim 1 wherein the radiographic marker material further comprises a tantalum powder dispersed in a matrix composed of a biocompatible adhesive.

8. The catheter of claim 7 wherein the ratio of tantalum to adhesive is about 3 to 1.

9. The catheter of claim 1 wherein radiographic marker made a material is also detectable during nuclear magnetic resonance imaging (MRI).

10. The catheter of claim 9 wherein the radiographic material is selected from the group consisting of platinum, tantalum, and cobalt.

5. The catheter wherein the material of the inner liner is selected from the group consisting of relatively nonporous polyethylene, poly tetrafluoroethylene, and polyurethane.

11. A catheter system for delivering fluid to a selected site within an organism, comprising:

a pump for delivering the fluid; and

a catheter coupled to the pump, the catheter comprising;

a jacket having a proximal and a distal end;

an inner liner forming a lumen, the inner liner having a proximal end and a distal end, the inner liner disposed inside the jacket and made of a material that is flexible and non-reactive with the agent, drug or fluid to be delivered through the inner liner, the proximal end of the inner liner adapted to be in fluid communication with a source of fluid;

a tip, integrally formed as the distal end of and in fluid communication with the lumen of the inner liner, the tip extending distally beyond the distal end of the jacket, the tip having at least one orifice for delivering fluid from the lumen of the inner liner to outside the catheter at the distal end of the catheter through the orifice, the tip made of the same material as the inner liner;

a radiographic marker attached to the distal end of the catheter, the radiographic marker comprising a semispherical portion with a cylindrical nipple emanating away therefrom, the cylindrical nipple being sized to fit snugly within the lumen and held in place by a biocompatible adhesive, the radiographic marker being made of a material opaque to x-rays;

whereby the jacket is isolated from fluid flowing in lumen, and

whereby the fluid flowing through the lumen contacts only the material of the lumen of the inner liner and tip as the fluid flows through the lumen and out the orifice.

12. The catheter system of claim 11 wherein the pump is adapted for subcutaneous disposition in the organism.

13. The catheter system of claim 11 wherein the pump is adapted for placement external to the organism.

14. The catheter system of claim 11 wherein the inner liner is selected from the group consisting of relatively nonporous polyethylene, poly tetrafluoroethylene, and polyurethane.

15. The catheter system of claim 11 wherein the jacket is selected from the group consisting of silicone, barium loaded silicone, polyurethane, polyether urethane, polyether urethane urea and styrene butadiene rubber.