Drug delivery and dilatation catheter

• US 5,295,962 A
• Filed: 12/18/1992
• Issued: 03/22/1994
• Est. Priority Date: 04/29/1992
• Status: Expired due to Term

• Current Assignee: CardioVascular Dynamics, Inc. (Radiance Medical Systems, Inc.)
• Original Assignee: CardioVascular Dynamics, Inc. (Radiance Medical Systems, Inc.)
• Inventors: Henson, Michael R., Crocker, Michael D., Chum, Muny
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Maglione, Corrine
• Application Number:
  US07/992,835
• Time in Patent Office: 459 Days
• Field of Search: 604/53, 604/96, 604/101, 606/192, 606/194
• US Class Current: 604/101.02
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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 2025/0183 Rapid exchange or monorail catheters
• 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 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/0043 characterised by structural features
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An improved drug delivery catheter, for use in the prevention of restenosis of a dilated vascular region, and/or for use in the delivery of a medication to a preselected vascular site. The catheter comprises an elongate body, an inflation balloon disposed about a catheter body. In a drug delivery embodiment, a perforated drug delivery balloon is disposed concentrically about the inflation balloon. In another embodiment, the two balloons are heat sealed together at the distal and proximal ends of the catheter body. A first lumen extends through the catheter body for communicating with the inflation balloon, and a second lumen extends through the body for communicating with the drug delivery balloon. Methods describing the intraluminal delivery of drugs to a site specific location are also disclosed, including the delivery of a drug to a vascular area before, during or after a conventional PTCA procedure.

Claims

1. A drug delivery and balloon dilatation catheter, comprising:

an elongate catheter body, having proximal and distal ends;

an inflation balloon on the distal end of the catheter body, the inflated profile of said inflation balloon having proximal and distal conical sections and a central cylindrical section,

a delivery balloon on the catheter, disposed about the inflation balloon;

a first lumen extending through the catheter for communication with the inflation balloon;

a second lumen extending through the catheter for communication with the delivery balloon;

a proximal annular seal between the inflation balloon and the delivery balloon; and

a distal annular seal between the inflation balloon and the delivery balloon;

wherein said proximal and distal annular seals extend axially into the conical sections of the inflation balloon so that deflation of the inflation balloon will cause a reduction in the exterior profile of the delivery balloon.

2. A delivery catheter as in claim 1, wherein said inflation balloon comprises polyethylene.

3. A delivery catheter as in claim 2, wherein said delivery balloon comprises polyethylene.

4. A delivery catheter as in claim 1, wherein the sum of the axial lengths of the proximal and distal annular seals in within the range of from about 10% to about 60% of the axial length of the delivery balloon.

5. A delivery catheter as in claim 4, wherein at least one of said proximal and distal annular seals extends for approximately 25% of the axial length of the delivery balloon.

6. A delivery catheter as in claim 1, wherein said delivery balloon comprises a plurality of delivery ports.

7. A delivery catheter as in claim 6, wherein said delivery ports are between about 100 microns and about 300 microns in diameter.

8. A delivery catheter as in claim 7, wherein said delivery ports are preferably about 250 microns in diameter.

9. A delivery catheter as in claim 6, wherein the total cross-sectional area of all of said delivery ports is at least 300% of the cross-sectional area of the second lumen.

10. A delivery catheter as in claim 1, wherein said delivery balloon comprises between about 3 and 50 delivery ports.

11. A delivery catheter as in claim 1, further comprising a delivery passageway extending through said proximal annular seal to provide communication between the second lumen and the delivery balloon.

12. A delivery catheter as in claim 1, wherein the deflated profile of the delivery balloon is preferably between 0.025 inches and 0.070 inches in diameter.

13. A delivery and balloon dilatation catheter for delivering a quantity of a fluid to a preselected site in a body lumen, comprising:

an elongate catheter body having proximal and distal ends;

a cross linked polyethylene inflation balloon on the distal end of the catheter body the inflated profile of said inflation balloon having proximal and distal control sections and a central cylindrical section;

a delivery balloon on the catheter, disposed coaxially about the inflation balloon;

a first lumen extending through the catheter for communication with the inflation balloon;

a second lumen extending through the catheter for communication with the delivery balloon;

a first annular seal between the distal end of the inflation balloon and the delivery balloon, said first annular seal extending axially into the cylindrical section of the inflation balloon;

a second annular seal between the proximal end of the inflation balloon and the delivery balloon, said second annular seal extending axially into the cylindrical section of the inflation balloon; and

a delivery passageway extending through said second annular seal to provide communication between the second lumen and the delivery balloon;

wherein deflation of the inflation balloon will cause a reduction in the exterior profile of the delivery balloon.

14. A delivery catheter as in claim 13, wherein from about 10% to 60% of the axial length of the delivery balloon is bonded to the inflation balloon.

15. A delivery catheter as in claim 14, wherein said first annular seal extends approximately 25% of the axial length of the delivery balloon.

16. A delivery catheter as in claim 14, wherein said second annular seal extends approximately 25% of the axial length of the delivery balloon.

17. A delivery catheter as in claim 13, further comprising a wire receiving lumen extending throughout at least a portion of the axial length of the catheter, wherein the longitudinal axis of the wire receiving lumen is co-axial to the inflation balloon on the distal end of the catheter body.

18. A delivery catheter as in claim 13, wherein said delivery balloon comprises a plurality of delivery ports.

19. A delivery catheter as in claim 18, wherein said delivery ports are between about 100 μ

m and about 300 μ

m in diameter.

20. A delivery catheter as in claim 19, wherein said delivery ports are preferably about 250 μ

m in diameter.

21. A delivery catheter as in claim 18, wherein said delivery balloon comprises between about 3 and 50 delivery ports.

22. A delivery catheter as in claim 13, wherein a majority of the length of said catheter body has a cross sectional area which i generally triangular in shape.

23. A delivery catheter as in claim 13, wherein said fluid is delivered intraluminally.