MEDICAL DEVICE WITH THERAPEUTIC AGENTS

• US 20080051737A1
• Filed: 10/31/2007
• Published: 02/28/2008
• Est. Priority Date: 04/16/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Sirota, Daniel, Amarant, Paul, Paul, Ram
• Granted Patent: US 7,780,647 B2
• Time in Patent Office: Days
• US Class Current: 604/265
• 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 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections

Abstract

A medical device is adapted for at least partial implantation into a body and includes first and second sections along the length of the device. A first therapeutic agent is associated with the first section and a second therapeutic agent is associated with the second section. The first therapeutic agent can be one or more antiproliferative, such as paclitaxel, a paclitaxel derivative, or a paclitaxel pro-drug, anti-coagulant, antithrombotic, thrombolytic, fibrinolytic, or combination thereof. The second therapeutic agent can be one or more antimicrobials, such as one or more antibiotics. Each of the first and second therapeutic agents can either be posited on one or more surfaces of the respective section, or impregnated within the section. The device can include a separator to space the first and second sections. A method of making a medical device and a method of establishing access to a vessel within a body are also provided.

Claims

1. A medical device for at least partial implantation, comprising:

a main body having a length extending between a first end and a second end, the main body including a first tube at least partially positioned within a lumen of a second tube to form an annular space between an interior surface of the second tube and an exterior surface of the first tube, the first tube having a lumen extending from the first end to the second end;

a first section along the length of the main body proximal the first end of said main body and having a first therapeutic agent, said first therapeutic agent comprising one or more members selected from the group consisting of antiproliferatives, anticoagulants, antithrombotics, thrombolytics, and fibrinolytics; and

a second section along the length of the main body proximal the second end of said main body and having a second therapeutic agent, said second therapeutic agent comprising an antimicrobial.

2. The medical device of claim 1, wherein the main body has a length such that when said device is at least partially implanted said first end accesses a body vessel and at least a portion of said second section is disposed within a subcutaneous space of a patient.

3. The medical device of claim 1, wherein the first therapeutic agent is positioned within the annular space between the first tube and the second tube.

4. The medical device of claim 3, wherein at least the portion of the second tube is formed of a porous material.

5. The medical device of claim 3, wherein the medical device further comprises a seal positioned between a first end of the first tube and a first end of the second tube to prevent escape of the first therapeutic agent directly from the annular space between the first tube and the second tube.

6. The medical device of claim 1, wherein the second therapeutic agent is positioned on or within the second tube.

7. The medical device of claim 1, wherein the medical device is characterized by the following:

(a) the main body has a length such that when said device is at least partially implanted said first end accesses a body vessel and at least a portion of said second section is disposed within a subcutaneous space of a patient;

(b) the first therapeutic agent is positioned within the annular space between the first tube and the second tube;

(c) at least the portion of the second tube is formed of a porous material;

(d) the medical device further comprises a seal positioned between a first end of the first tube and a first end of the second tube to prevent escape of the first therapeutic agent directly from the annular space between the first tube and the second tube; and

(e) the second therapeutic agent is positioned on or within the second tube.

8. The medical device of claim 1, wherein the medical device further comprises an access line in communication with the annular space.

9. The medical device of claim 8, wherein the medical device further comprises a seal positioned proximal to the access line.

10. The medical device of claim 9, wherein at least a portion of the second tube is formed of a porous material.

11. The medical device of claim 10, wherein the first therapeutic agent is contained within the annular space distal to the seal.

12. The medical device of claim 11, wherein the second therapeutic agent is contained in one or more portions of the medical device selected from the group consisting of:

the annular space proximal to the seal, on a surface of the first tube, on a surface of the second tube, within the first tube and within the second tube.

13. The medical device of claim 1, wherein the medical device comprises a catheter forming the main body and having the first section and the second section positioned along the length of the second tube.

14. The medical device of claim 13, wherein the first section of the catheter comprises a coating of the first therapeutic agent on the exterior surface of the second tube.

15. The medical device of claim 14, wherein the second section of the catheter comprises the second therapeutic agent coated on the exterior surface of the second tube, proximal to the first section.

16. The medical device of claim 13, wherein at least the portion of the second tube is formed of a porous material forming a portion of the exterior surface of the catheter.

17. The medical device of claim 13, wherein the catheter has a length such that when said catheter is at least partially implanted said first end accesses a body vessel and at least a portion of said second section is disposed within a subcutaneous space of a patient.

18. The medical device of claim 1, wherein

(a) the medical device further comprises an access line in communication with the annular space;

(b) the medical device further comprises a seal positioned proximal to the access line;

(c) at least a portion of the second tube is formed of a porous material;

(d) the first therapeutic agent is contained within the annular space distal to the seal;

(e) the second therapeutic agent is contained in one or more portions of the medical device selected from the group consisting of;

the annular space proximal to the seal, on a surface of the first tube, on a surface of the second tube, within the first tube and within the second tube;

(f) the medical device comprises a catheter forming at least a portion of the main body and having the first section and the second section positioned along the length of the second tube;

(g) the first section of the catheter comprises a coating of the first therapeutic agent on the exterior surface of the second tube;

(h) the second section of the catheter comprises the second therapeutic agent coated on the exterior surface of the second tube, proximal to the first section;

(i) at least the portion of the second tube formed of the porous material also forms a portion of the exterior surface of the catheter; and

(j) the catheter has a length such that when said catheter is at least partially implanted said first end accesses a body vessel and at least a portion of said second section is disposed within a subcutaneous space of a patient.

19. A method of establishing access to a vessel of the body, the method comprising

(a) implanting a distal portion of medical device within a body vessel with a proximal portion of the medical device outside the body vessel, the medical device including:

(i) a main body having a length extending between a first end and a second end, the main body including a first tube at least partially positioned within a lumen of a second tube to form an annular space between an interior surface of the second tube and an exterior surface of the first tube, the first tube having a lumen extending from the first end to the second end;

(ii) a first section along the length of the main body proximal the first end of said main body and having a first therapeutic agent, said first therapeutic agent comprising one or more members selected from the group consisting of antiproliferatives, anticoagulants, antithrombotics, thrombolytics, and fibrinolytics; and

(iii) a second section along the length of the main body proximal the second end of said main body and having a second therapeutic agent, said second therapeutic agent comprising an antimicrobial; and

(b) forming an interface between the distal end and the vessel to provide access to the vessel through the lumen of the first tube.

20. A method of making a medical device for at least partial implantation within a body, the method comprising

(a) providing a main body having a first end, a second end, a length extending from the first end to the second end, a first section along the length, and a second section along the length;

(b) exposing the first section to a solvent so that the first sections swells;

soaking the first section in a solution containing a first therapeutic agent;

drying the first section; and

(c) coating at least a portion of the second section with a second therapeutic agent.