BALLOON CATHETER FOR DELIVERING A THERAPEUTIC AGENT

• US 20110060276A1
• Filed: 09/11/2008
• Published: 03/10/2011
• Est. Priority Date: 09/12/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Schaeffer, Darin G., Lentz, David Christian
• Granted Patent: US 8,182,446 B2
• Time in Patent Office: Days
• US Class Current: 604/101.05
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1056 having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: Y10T 29/49865 by temperature differential [e.g., shrink fit]

Abstract

Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel. Preferably, the catheter balloon assemblies include a stiffening′ member (210) within the proximal portion and/or a plurality of lumens lined with a fluorinated hydrocarbon to independently inflate the inner balloon, deliver the therapeutic agent through the outer balloon and house a wire guide (50). The catheter balloon assemblies may provide improved tractability and/or pushability characteristics.

Claims

1. A balloon intraluminal drug delivery catheter assembly comprising:

a catheter shaft extending from a proximal end to a distal end including an outer sleeve disposed along a portion of the catheter shaft, a first tubular member defining an inflation lumen and a second tubular member defining a fluid delivery lumen, the first and second tubular members each disposed within the outer sleeve and extending through at least a portion of the catheter shaft, with the first and second tubular members being adjacent with respect to each other, the catheter shaft further comprising a thermoformable polymer disposed within the outer sleeve and about the first and second tubular members;

a first balloon mounted on a distal region of the catheter shaft in communication with the inflation lumen; and

a second balloon disposed about at least a portion of the first balloon and defining an annular balloon fluid delivery lumen between the first balloon and the second balloon in communication with the fluid delivery lumen, the second balloon including a plurality of apertures in communication with the annular balloon fluid delivery lumen, the plurality of apertures being disposed along a longitudinal portion of the second balloon and having a total cross sectional area that increases in a distal longitudinal direction along the second balloon.

2. The drug delivery catheter of claim 1 further comprising a stiffening member within a portion of the catheter shaft and disposed within the outer sleeve adjacent with respect to the first and second tubular members, a portion of the stiffening member being surrounded by the thermoformable polymer, where the stiffening member is in non-translatable contact with the thermoformable polymer.

3. The drug delivery catheter of claim 2, where at least a distal portion of the stiffening member comprises a tapered member with a transverse cross-sectional area that decreases along the distal longitudinal direction.

4. The drug delivery catheter of claim 1, where the total cross sectional area of the plurality of apertures increases in the distal longitudinal direction by at least one of increasing the size of the apertures and increasing the density of the apertures along the distal longitudinal direction along the second balloon.

5. The drug delivery catheter of claim 1, where the catheter shaft further comprises a third tubular member defining a guide wire lumen, the third tubular member disposed within the outer sleeve and being adjacent with respect to the first and second tubular members, a portion of the third tubular member being surrounded by the thermoformable polymer.

6. The drug delivery catheter of claim 5, where the catheter shaft comprises an intermediate region interposed between a proximal region and the distal region and a wire guide port disposed along the intermediate region, and where the third tubular member includes a proximal end in communication with the wire guide port and a distal end proximate the distal end of the catheter shaft.

7. The drug delivery catheter of claim 5, where the catheter shaft comprises a wire guide port disposed proximate the proximal end of the catheter shaft, and where the third tubular member includes a proximal end in communication with the wire guide port and a distal end proximate the distal end of the catheter shaft.

8. The drug delivery catheter of claim 1, where the first balloon comprises a polyamide material and is attached to the catheter shaft at a first balloon proximal seal and a first balloon distal seal, the first balloon being unattached to the second balloon between the first balloon proximal and distal seals.

9. The drug delivery catheter of claim 8, where the second balloon comprises a polyamide material and is attached to the catheter shaft at a second balloon proximal seal and a second balloon distal seal, where the second balloon proximal and distal seals are disposed axially outward of the first balloon proximal and distal seals.

10. The drug delivery catheter of claim 1, where the catheter shaft further comprises a first portion having the inflation lumen and the fluid delivery lumen in a coaxial configuration and a second portion having the inflation lumen and the fluid delivery lumen in a side-by-side configuration.

11. The drug delivery catheter of claim 1, where the first and second tubular members comprise fluorinated hydrocarbon tubular liner, and the thermoformable polymer has a lower melting temperature than the fluorinated hydrocarbon tubular liner.

12. The drug delivery catheter of claim 1, where the outer sleeve of the catheter shaft comprises a cross-linked heat-shrinkable polymer.

13. The drug delivery catheter of claim 12, where the cross-linked heat-shrinkable polymer includes a polymer selected from the group consisting of:

high density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), polyester or polyether block amide (PEBA), polyurethane, polyimide, polyolefin and nylonpolyether block amide (PEBA).

14. The drug delivery catheter of claim 1, where the first and second balloons are formed from material having substantially equal Young'"'"'s modulus.

15. The drug delivery catheter of claim 1, where the first and second tubular members comprise polytetrafluoroethylene (PTFE).

16. The drug delivery catheter of claim 1, where the thermoformable polymer is selected from the group consisting of:

polyolefin, polyester or polyether block amide (PEBA).

17. The drug delivery catheter of claim 1, where the catheter shaft has a diameter of less than about 9 French and has a burst pressure of about at least 2.7 MPa (27 atmospheres).

18. The drug delivery catheter of claim 1, where the burst pressure of the catheter shaft is greater than the burst pressure of any one of the outer sleeve and the first and second tubular members.

19. A method of making a drug delivery catheter comprising the steps of:

(a) aligning a first tubular member and a second tubular member substantially parallel and adjacent with respect to each other, where each tubular member is formed from a fluorinated hydrocarbon tubular liner;

(b) disposing the first and second tubular members and a thermoformable polymer within an outer sleeve, where the thermoformable polymer contacts the first and second tubular members, the outer sleeve being formed from a heat-shrinkable polymer;

(c) applying heat to the outer sleeve with the tubular members and the thermoformable polymer to melt the thermoformable polymer and shrink the outer sleeve in order to join the first and second tubular members in a fixed orientation to one another within the outer sleeve to form a catheter shaft;

(d) attaching a first expandable material to a distal region of the catheter shaft to form the first balloon in fluid communication with a distal end of the first tubular member;

(e) attaching a second expandable material to the distal region of the catheter shaft about the first balloon such that an annular balloon fluid delivery lumen is formed between the second balloon and the first balloon, the annular balloon fluid delivery lumen being in fluid communication with a distal end of the second tubular member; and

(f) forming the plurality of apertures in the second expandable material, where the plurality of apertures define a total cross sectional area that increases in a distal longitudinal direction along the second balloon.

20. The method of claim 19, wherein disposing step further comprises disposing a stiffening member within the outer sleeve adjacent with respect to the first and second tubular members, with at least a portion of the stiffening member being surrounded by the thermoformable polymer, so that after application of heat the stiffening member is in non-translatable contact with the thermoformable polymer.