Method and apparatus for pressurized intraluminal drug delivery

• US 5,810,767 A
• Filed: 05/10/1996
• Issued: 09/22/1998
• Est. Priority Date: 05/11/1994
• Status: Expired due to Fees

• Current Assignee: LocalMed, LLC (Dental Intelligence, Inc.)
• Original Assignee: LocalMed, LLC (Dental Intelligence, Inc.)
• Inventors: Klein, Enrique J.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/644,790
• Time in Patent Office: 865 Days
• Field of Search: 604/53, 604/96, 604/101, 604/104-106, 604/265-266, 604/280, 606/192, 606/194, 606/198
• US Class Current: 604/509
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4488 the transducer being a phased array
• 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 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• 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 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• 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 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

An intravascular catheter provides fluid infusion tubes over a balloon surface to form isolated reservoir pockets for delivering drugs intraluminally. The fluid infusion tubes will be arranged in a network which, upon balloon expansion, defines the isolated reservoir pockets between adjacent tubes. In one embodiment, the drug infusion tubes are formed as part of an expansible sleeve which is positioned over a separate balloon catheter for expansion. In another embodiment, the infusion tubes are disposed over a balloon of a balloon catheter.

Claims

1. A method for intramural fluid delivery, said method comprising:

expanding a balloon within a body lumen, said balloon having an outer peripheral surface;

providing a plurality of isolated fluid reservoir pockets between the outer peripheral surface of the balloon and an inner wall portion of the body lumen; and

delivering fluid to said isolated pockets, wherein at least some of the individual reservoir pockets are surrounded by a continuous periphery of the infusion tubes which deliver fluid to the pockets.

2. A method as in claim 1, wherein the body lumen is a blood vessel.

3. A method as in claim 1, wherein from 6 to 64 isolated pockets are provided and wherein the isolated pockets each have an area in the range from 10 mm² to 60 mm².

4. A method as in claim 3, wherein the isolated pockets are substantially uniformly distributed over the outer peripheral surface of the balloon.

5. A method as in claim 1, wherein the balloon is inflated to a pressure in the range from 0.5 atm to 6 atm and wherein the fluid is delivered to said isolated pockets at a delivery pressure in the range from 0.5 psi to 10 psi.

6. A method as in claim 1, wherein the fluid is delivered to said isolated pockets from delivery lumens and through flow-limiting infusion ports, wherein the delivery lumens and flow-limiting infusion ports are present on a catheter which carries the balloon.

7. A method as in claim 6, wherein the flow-limiting infusion ports open to a single isolated pocket have an aggregate cross-sectional area which is from 5% to 20% of the cross-section area of the delivery lumen.

8. A method as in claim 1, wherein the providing step comprises disposing a network of fluid infusion tubes between the balloon and the inner wall portion, wherein the fluid infusion tubes are arranged to form said isolated pockets.

9. A method as in claim 8, wherein the fluid infusion tubes are arranged to form a diamond pattern when the balloon is expanded.

10. A method as in claim 8, wherein the network of fluid infusion tubes is disposed on an expansible sleeve which is positioned between the balloon and the luminal wall prior to balloon expansion.

11. A method as in claim 10, wherein the balloon is non-distensible.

12. A method as in claim 10, wherein the balloon is elastomeric.

13. A method as in claim 8, wherein the network of fluid infusion tubes is disposed as an integral component of the balloon.

14. A method as in claim 13, wherein the balloon is non-distensible.

15. A method as in claim 13, wherein the balloon is elastomeric.

16. An infusion catheter for intramural drug delivery within a body lumen, said infusion catheter comprising:

a catheter body having a proximal end, a distal end, and a fluid delivery lumen therethrough; and

a radially expansible segment disposed at the distal end of the catheter body, said radially expansible segment having a network of fluid infusion tubes which are arranged to form a plurality of isolated pockets when said segment is expanded against a body lumen wall, said fluid infusion tubes having infusion ports for delivering fluids into said isolated pockets, wherein at least some of said isolated pockets are surrounded by a continuous periphery of infusion tubes when said pockets are disposed against a lumenal wall.

17. An infusion catheter as in claim 16, further comprising a balloon near the distal end of the catheter body, wherein the network of infusion tubes are formed over an outer peripheral surface of the balloon.

18. An infusion catheter as in claim 17, wherein the balloon is non-distensible and the infusion tubes are integrally formed therewith.

19. An infusion catheter as in claim 17, wherein the balloon is elastomeric and the infusion tubes are formed from a different material and attached to the balloon.

20. An infusion catheter as in claim 16, wherein the infusion ports opening to a single isolated pocket have an aggregate cross-sectional area which is from 5% to 20% of the cross-section area of the delivery lumen.

21. An infusion catheter as in claim 16, wherein the radially expansible segment comprises a receptacle which receives and is expanded by a balloon of a balloon catheter deployed therein.

22. An infusion catheter as in claim 16, wherein the network of infusion tubes forms from 6 to 64 isolated pockets disposed substantially uniformly over the expansible segment and wherein the isolated pockets each have an area in the range from 10 mm² to 60 mm².

23. An infusion catheter as in claim 16, wherein the fluid infusion tubes are arranged to form a diamond pattern when the expansible segment is expanded.

24. An infusion catheter as in claim 16, wherein the catheter body comprises a shaft having the fluid delivery lumen therethrough and wherein the radially expansible segment comprises a sleeve having the fluid infusion tubes formed thereover.

25. An infusion catheter as in claim 24, further comprising a manifold structure disposed between the shaft and the network of infusion tubes which distributes fluid from the fluid delivery lumen to the fluid infusion tubes.

26. An infusion catheter for use in combination with a balloon catheter, said infusion catheter comprising:

a catheter body having a proximal and a distal end;

a radially expansible sleeve disposed at the distal end of the catheter body, said radially expansible sleeve having a central receptacle, for receiving a balloon or the balloon catheter, and a network of fluid infusion tubes which are arranged to form a plurality of isolated pockets when expanded by the balloon present in the central receptacle, said fluid infusion tubes having infusion ports for delivering fluids into said isolated pockets, wherein at least some of said isolated pockets are surrounded by a continuous periphery of infusion tubes when said pockets are disposed against a lumenal wall.

27. An infusion catheter as in claim 26, wherein the catheter body comprises a shaft having a fluid delivery lumen therethrough.

28. An infusion catheter as in claim 27, further comprising a manifold structure disposed between the shaft and the network of infusion tubes which distributes fluid from the fluid delivery lumen to the fluid infusion tubes.

29. An infusion catheter as in claim 26, wherein the infusion ports opening to a single isolated pocket have an aggregate cross-sectional area which is from 5% to 20% of the cross-section area of the delivery lumen.

30. An infusion catheter as in claim 26, wherein the network of infusion tubes forms from 6 to 64 isolated pockets disposed substantially uniformly over the expansible segment and wherein the isolated pockets each have an area in the range from 10 mm² to 60 mm².

31. An infusion catheter as in claim 26, wherein the fluid infusion tubes are arranged to form a diamond pattern when the segment is expanded.

32. An infusion catheter for use in combination with a balloon catheter, said infusion catheter comprising:

a shaft having a proximal and a distal end and a fluid delivery lumen therethrough;

a radially expansible sleeve disposed at the distal end of the shaft, said radially expansible sleeve having a (i) central receptacle for receiving a balloon or the balloon catheter and (ii a network of fluid infusion tubes which are arranged to form a plurality of isolated pockets when the sleeve is expanded by the balloon present in the central receptacle, said fluid infusion tubes having infusion ports for delivering fluids into said isolated pockets; and

a manifold structure disposed between the shaft and the network of infusion tubes which distributes fluid from the fluid delivery lumen to the fluid infusion tubes.

33. An infusion catheter as in claim 32, wherein the infusion ports opening to a single isolated pocket have an aggregate cross-sectional area which is from 5% to 20% of the cross-section area of the delivery lumen.

34. An infusion catheter as in claim 32, wherein the network of infusion tubes forms from 6 to 64 isolated pockets disposed substantially uniformly over the expansible segment.

35. An infusion catheter as in claim 32, wherein the isolated pockets each have an area in the range from 10 mm² to 60 mm².

36. An infusion catheter as in claim 32, wherein said radially expansible sleeve has reinforcing ribs within the fluid infusion tube network.

37. An infusion catheter as in claim 32, wherein the fluid infusion tubes are arranged to form a diamond pattern when the sleeve is expanded.