Composite drug delivery catheter

• US 6,824,532 B2
• Filed: 01/28/2002
• Issued: 11/30/2004
• Est. Priority Date: 06/23/1999
• Status: Expired due to Fees

• Current Assignee: DURECT Corporation
• Original Assignee: DURECT Corporation
• Inventors: Gillis, Edward M., Theeuwes, Felix
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US10/059,895
• Publication Number:
  US 20020095133A1
• Time in Patent Office: 1,037 Days
• Field of Search: 604/264, 604/96.01, 604/101-1-1, 604/523, 604/524, 604/525, 604/526, 604/527, 604/528, 604/529, 604/530, 604/532, 604/533, 604/534, 604/535, 606/191-194
• US Class Current: 604/264
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts

Abstract

The present invention features a composite catheter comprising an elongate outer member and an elongate inner member positioned within the outer member so that the inner and outer members define an interstitial space. The outer member has a size and other characteristics that facilitate handling and implantation of the composite catheter, while the inner diameter of the inner member has the size and other characteristics suitable for delivery of a drug through a lumen of the inner member. The interstitial space imparts flexibility to the composite catheter by, for example, removing material from the cross-sectional area that would otherwise provide additional stiffness to the catheter, and/or by accommodating movement of the outer member relative to the inner member.

Claims

1. A method for delivery of a drug to a treatment site in a subject, the method comprising the steps of:

(a) implanting a composite catheter into a subject, the composite catheter comprising;

an outer member comprising a proximal end, a distal end, and an outer member body defining an outer member lumen; and

an inner member comprising a proximal end, a distal end, and an inner member body defining an inner member lumen, wherein the inner member is interposed within the outer member lumen so as to define an interstitial space between the inner member and the outer member, wherein the inner member body comprises a substantially impermeable material selected from the group consisting of a polymer, metal, glass, a polyolefin, nylon, polyethylene terephtholate, urethane, a fluorenated polymer, poly(methyl)methacrylate, polyvinylidine chloride, laminous hydrophilic polymer, laminous hydrophobic polymer, acrylonitrile, nickel titanium, superelastic nickel titanium, and laminates of hydrophilic and hydrophobic polymers, and wherein the inner member lumen defines a drug delivery conduit suitable for delivery of a drug from the inner member proximal end to the inner member distal end, wherein said implanting provides a drug delivery pathway from a proximal end of the catheter, through the inner member lumen to a distal end of the catheter, and out a drug delivery outlet positioned at a treatment site in a subject; and

(b) introducing a drug into the inner lumen of the catheter, wherein the drug is delivered to the treatment site in the subject.

2. The method of claim 1, wherein the inner member lumen is suitable for delivery of the drug at a low volume delivery rate.

3. The method of claim 2, wherein the low volume delivery rate is from about 0.01 μ

l/day to about 200 μ

l/day.

4. The method of claim 1, wherein the catheter is substantially filled with the drug prior to implanting.

5. The method of claim 1, wherein the catheter further comprises a distal extension at the distal end of the catheter, wherein the distal extension is flexible.

6. The method of claim 1, wherein the treatment site is subcutaneous, percutaneous, intravenous, intrathecal, intramuscular, intra-arterial, intravascular, intraperitoneal, intraspinal, epidural, intracranial, intracardial, peritumoral, or intratumoral.

7. The method of claim 2, wherein the treatment site is a site within a kidney, liver, pancreas, heart, lung, eye, ear, lymph node, breast, prostate, ovary, testicle, thyroid, spleen, central nervous system, skeletal muscle, bone, lymph vessel, artery, arteriole, capillary bed, blood vessel, vein, peripheral nervous system, digestive system, gastrointestinal tract, urinary bladder, gall bladder, adrenal gland, adipose tissue, parathyroid gland, uterus, fallopian tube, skin, tumorous growth, autologous graft, synthetic graft, or site of microbial infection.

8. A method for delivery of a drug to a treatment site in a subject, the method comprising the steps of:

(a) implanting a composite catheter into a subject, the composite catheter comprising;

an outer member comprising a proximal end, a distal end, and an outer member body defining an outer member lumen, wherein the outer member body comprises a substantially biocompatible material selected from the group consisting of silicone, polyethylene, an ethylene vinyl acetate copolymer, a polyvinylchloride, polymethylmethacrylate, polyethylmethacrylate, polymethacrylate, ethylene glycol dimethacrylate, ethylene dimethacrylate, hydroxymethyl methacrylate, polyurethane, polyvinylpyrrolidone, 2-pyrrolidone, polyacrylonitrile butadiene, a polycarbonate, polyamides, a fluoropolymers, a polystyrene, a styrene acrylonitrile homopolymer, a styrene acrylonitrile copolymer, cellulose acetate, an acrylonitrile butadiene styrene homopolymer, acrylonitrile butadiene styrene copolymer, polyvinylchloride, silicone rubber, polymethylpentene, a polysulfone, a polyester, a polyimide, polyisobutylene, polymethylstyrene, a polyvinyl chloride elastomer, a polyolefin homopolymeric elastomer, a polyolefine copolymeric elastomer, a urethane-based elastomer, a natural rubber, and a synthetic rubber, and

an inner member comprising a proximal end, a distal end, and an inner member body defining an inner member lumen, wherein the inner member is interposed within the outer member lumen so as to define an interstitial space between the inner member and the outer member, and wherein the inner member lumen defines a drug delivery conduit suitable for delivery of a drug from the inner member proximal end to the inner member distal end, wherein said implanting provides a drug delivery pathway from a proximal end of the catheter, through the inner member lumen to a distal end of the catheter, and out a drug delivery outlet positioned at a treatment site in a subject; and

(b) introducing a drug into the inner lumen of the catheter, wherein the drug is delivered to the treatment site in the subject.

9. The method of claim 8, wherein the inner member lumen is suitable for delivery of the drug at a low volume delivery rate.

10. The method of claim 9, wherein the low volume delivery rate is from about 0.01 μ

l/day to about 200 μ

l/day.

11. The method of claim 8, wherein the catheter is substantially filled with the drug prior to implanting.

12. The method of claim 8, wherein the catheter further comprises a distal extension at the distal end of the catheter, wherein the distal extension is flexible.

13. The method of claim 8, wherein the treatment site is subcutaneous, percutaneous, intravenous, intrathecal, intramuscular, intra-arterial, intravascular, intraperitoneal, intraspinal, epidural, intracranial, intracardial, peritumoral, or intratumoral.

14. A method for delivery of a drug to a treatment site in a subject, the method comprising the steps of:

(a) implanting a composite catheter into a subject, the composite catheter comprising;

an outer member comprising a proximal end, a distal end, and an outer member body defining an outer member lumen,

an inner member comprising a proximal end, a distal end, and an inner member body defining an inner member lumen, wherein the inner member is interposed within the outer member lumen so as to define an interstitial space between the inner member and the outer member, and wherein the inner member lumen defines a drug delivery conduit suitable for delivery of a drug from the inner member proximal end to the inner member distal end, and

a support member positioned within the interstitial space, wherein the support member comprises a material selected from the group consisting of metal, a metal alloy, carbon fiber, a polycarbonate, a polymer, plexiglass, stainless steel, parylene-coated stainless steel, Teflon-coated stainless steel, and nickel titanium, wherein said implanting provides a drug delivery pathway from a proximal end of the catheter, through the inner member lumen to a distal end of the catheter, and out a drug delivery outlet positioned at a treatment site in a subject; and

(b) introducing a drug into the inner lumen of the catheter, wherein the drug is delivered to the treatment site in the subject.

15. The method of claim 14, wherein the inner member lumen is suitable for delivery of the drug at a low volume delivery rate.

16. The method of claim 15, wherein the low volume delivery rate is from about 0.01 μ

l/day to about 200 μ

l/day.

17. The method of claim 14, wherein the catheter is substantially filled with the drug prior to implanting.

18. The method of claim 14, wherein the catheter further comprises a distal extension at the distal end of the catheter, wherein the distal extension is flexible.

19. The method of claim 14, wherein the treatment site is subcutaneous, percutaneous, intravenous, intrathecal, intramuscular, intra-arterial, intravascular, intraperitoneal, intraspinal, epidural, intracranial, intracardial, peritumoral, or intratumoral.