Intravascular catheter with infusion array

• US 5,609,574 A
• Filed: 05/11/1994
• Issued: 03/11/1997
• Est. Priority Date: 11/02/1992
• Status: Expired due to Fees

• Current Assignee: LocalMed, LLC (Dental Intelligence, Inc.)
• Original Assignee: LocalMed, LLC (Dental Intelligence, Inc.)
• Inventors: Kermode, James R., Kaplan, Aaron V., Klein, Enrique J.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/241,428
• Time in Patent Office: 1,035 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: 604/508
• 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 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• 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 2025/09183 having tools at the distal tip
• 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 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• 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 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• 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 means for infusing an agent into a treatment site in a body lumen and means for deploying the infusing means adjacent the treatment site which operate independently of one another. In a first embodiment, a flexible catheter body has an expansion member attached to its distal end in communication with an inflation passage, and an infusion array disposed about the expansion member in communication with one or more delivery passages. In a second embodiment, the infusion array is a separate component and slidably received over the expansion member, which may be a balloon dilatation catheter. In both embodiments, the infusion array includes a plurality of delivery conduits having laterally oriented orifices. The delivery conduits may be extended radially from the catheter body to contact a treatment site by expanding the expansion member with an inflation fluid. An agent may be introduced into the delivery passages and infused into the treatment site through orifices in the delivery conduits. The expansion member may be expanded for dilatation of the lumen before, during, or after infusion.

Claims

1. A method of delivering an agent to a treatment site on an interior wall of a blood vessel, the method comprising:

positioning a catheter in the blood vessel with an infusion array having a plurality of fluidly isolated delivery conduits at the distal end of the catheter near the treatment site, wherein each delivery conduit has a multiplicity of infusion orifices;

expanding an expansion member at the distal end of the catheter to position the infusion array adjacent to the treatment site, the expansion member being fluidly isolated from the infusion array;

thereafter, delivering an agent from a proximal housing to the infusion array such that delivery of the agent through each delivery conduit is controlled independently.

2. A method as in claim 1 wherein an agent is infused through a selected delivery conduit without infusing the agent through at least one other delivery conduit.

3. A method as in claim 1 wherein a first agent is infused through a first delivery conduit while a second agent is infused through a second delivery conduit.

4. Apparatus for infusing an agent in a body lumen, the apparatus comprising:

a catheter body having a distal end, a proximal end and an inflation passage and a plurality of independent delivery passages extending therebetween;

an expansion member attached to the catheter body near the distal end, the interior of the expansion member being in fluid communication with the inflation passage;

a plurality of delivery conduits disposed about the periphery of the catheter body near the distal end, each delivery conduit in communication with one of the delivery passages, wherein at least a portion of the delivery conduits are fluidly independent of others of the delivery conduits so as to be individually supplied with an agent through the delivery passages; and

a plurality of orifices on a lateral-facing surface of the delivery conduits for infusing the agent into the lumen.

5. The apparatus of claim 4 wherein the orifices are disposed on a portion of the delivery conduits disposed over the expansion member.

6. The apparatus of claim 4 wherein the orifices are disposed on a portion of the delivery conduits distally of the expansion member.

7. The apparatus of claim 4 wherein the orifices are disposed on a portion of the delivery conduits proximal to the expansion member.

8. The apparatus of claim 4 wherein the catheter body, delivery conduits and expansion member comprise a single monolithic extrusion.

9. Apparatus for infusing an agent to a treatment site on a wall of a body lumen, the apparatus comprising:

a catheter body having a distal end, a proximal end and first and second passages therebetween;

a guidewire extending from the distal end of the catheter body;

an expansion member disposed at the distal end of the catheter body, the interior of the expansion member being in fluid communication with the first passage; and

an infusion array fluidly isolated from the expansion member and disposed adjacent to a lateral surface thereof so as to be positionable adjacent to the treatment site by expansion of the expansion member, the infusion array comprising at least one delivery conduit having a plurality of orifices on a surface thereof and an axial lumen connecting the orifices to the second passage in the catheter body, wherein the catheter body, expansion member, and infusion array comprise a single monolithic extrusion.

10. Apparatus for infusing an agent to a treatment site on a wall of a body lumen, the apparatus comprising:

a catheter body having a distal end, a proximal end and at least first and second axial passages therebetween;

a second catheter having a distal end, a proximal end, and an expansion member connected proximally to its distal end, wherein the second catheter is removably disposed in the first passage of the catheter body; and

an infusion array at the distal end of the catheter body, wherein the infusion array comprises at least one laterally deflectable delivery conduit having a plurality of orifices on a surface thereof and an axial lumen connecting the orifices to the second axial passage in the catheter body.

11. The apparatus of claim 10 wherein the infusion array further comprises a plurality of said delivery conduits disposed about the periphery of the expansion member.

12. The apparatus of claim 11 wherein the catheter body further includes a plurality of independent delivery passages extending between the distal and proximal ends, each of the delivery passages being in communication with one of the delivery conduits.

13. The apparatus of claim 12 further comprising a manifold at the proximal end of the catheter body, the manifold being in fluid communication with each of said delivery passages and connectable to an agent delivery source.

14. The apparatus of claim 12 wherein an agent may be infused through a selected delivery conduit without infusing the agent through others of the delivery conduits.

15. The apparatus of claim 14 wherein a first agent may be infused through a first delivery conduit while a second agent is infused through a second delivery conduit.

16. The apparatus of claim 15 wherein each delivery passage includes means at the proximal end for independently introducing an agent into the delivery passage.

17. The apparatus of claim 10 wherein the infusion array is mounted on an expandable support member attached to the catheter body such that the expansion member engages the support member to position the infusion array adjacent to the treatment site.

18. The apparatus of claim 10 further comprising a movable guidewire, the catheter body further having a guidewire passage through which the movable guidewire is slidably disposed.

19. The apparatus of claim 10 wherein the infusion array infuses the agent into the treatment site at a pressure sufficient to penetrate to an adventitial layer of the body lumen.

20. Apparatus for infusing an agent to a treatment site on the wall of a body lumen, the apparatus comprising:

a flexible shaft having a distal end, a proximal end, and a guide passage, the guide passage being open at the distal end;

an inflation tube slidably disposed in the guide passage having a distal end, a proximal end, an axial inflation lumen therebetween, and an expansion member attached to the distal end in communication with the inflation lumen, wherein the expansion member may be advanced distally from the distal end of the shaft; and

a plurality of laterally-deflectable delivery conduits attached to the distal end of the shaft generally parallel thereto, each delivery conduit having an axial lumen and a plurality of orifices on a lateral surface thereof, wherein the expansion member is axially positionable adjacent to the delivery conduits for laterally positioning the delivery conduits in apposition to the treatment site; and

a plurality of fluidly independent delivery passages extending from the proximal end to the distal end of the shaft, wherein an axial lumen of each delivery conduit is in communication with at least one delivery passage and at least a first of the delivery conduits is in communication with a different delivery passage than at least a second of the delivery conduits so as to allow independent delivery of agents to the first and second delivery conduits.

21. The apparatus of claim 20 further comprising means for maintaining relative alignment of the delivery conduits during lateral deflection thereof.

22. The apparatus of claim 20 wherein the shaft, delivery passage and delivery conduits comprise a single monolithic extrusion.

23. The apparatus of claim 20 wherein the delivery conduits are separated from one another by axial splits in said extrusion.