Medical device for delivery of a biologically active material to a lumen

• US 7,569,032 B2
• Filed: 08/20/2003
• Issued: 08/04/2009
• Est. Priority Date: 11/28/2000
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Herrmann, Robbert A, Palasis, Maria, Naimark, Wendy
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): WITCZAK, CATHERINE
• Application Number:
  US10/645,652
• Publication Number:
  US 20040044308A1
• Time in Patent Office: 2,176 Days
• Field of Search: 604/164.01, 604/264, 604/507, 604/191, 604/500, 604/104, 604/96.01, 604103-10302, 604/103.08
• US Class Current: 604/103.01
• CPC Class Codes: A61M 2025/0093 wherein at least one needle is a microneedle
• 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 2025/1072 having balloons with two or more compartments
• 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 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• 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 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

An apparatus for delivery of biologically active materials comprises a catheter and balloon having micro-needles or pores. In the apparatus, the balloon can have a polymer coating containing the biologically active material, and the apparatus can include a sheath surrounding the balloon. In one embodiment the biologically active material is delivered through lumens in the micro-needles. Another embodiment of the invention is an apparatus for delivery of biologically active materials comprising a catheter with a balloon disposed thereon and a shockwave generator for producing a shockwave for delivering the biologically active material to a body lumen. Methods for delivery of biologically active materials are also disclosed.

Claims

1. An apparatus for delivering a biologically active material to a body lumen comprising:

a catheter having a distal portion and a proximal portion;

a balloon, having a balloon wall including a layer defining an outer surface and an inner surface, disposed at the distal portion of the catheter; and

a plurality of micro-needles disposed upon the outer surface of the balloon,

wherein the micro-needles are capable of contacting the body lumen to deliver the biologically active material to the body lumen; and

the micro-needles are disposed upon a plate, which is attached to the inner surface of the layer of said balloon wall in a manner such that the micro-needles project through the layer of the balloon wall.

2. The apparatus of claim 1, wherein the plate is attached to the balloon in a manner such that the micro-needles are capable of being retracted when the balloon is deflated and capable of being projected through the balloon wall when the balloon is expanded.

3. The apparatus of claim 1, wherein the plate is solid.

4. The apparatus of claim 1, wherein the plate is porous.

5. The apparatus of claim 1, wherein the balloon wall also includes an additional layer and the plate is between the layer and the additional layer.

6. The apparatus of claim 1, wherein the biologically active material is contained in the layer of the balloon wall.

7. The apparatus of claim 1, wherein the balloon includes a first compartment for storing the biologically active material and a second compartment for inflating the balloon.

8. An apparatus for delivering a biologically active material to a body lumen comprising:

(a) a catheter having a distal portion, a proximal portion and a first lumen therethrough;

(b) a balloon disposed at the distal portion of the catheter, wherein the balloon has an interior compartment in fluid communication with the first lumen of the catheter;

the balloon has an outer surface having a plurality of micro-needles disposed thereon; and

each micro-needle of said plurality of micro-needles has a lumen in fluid communication with the interior compartment and wherein the micro-needles are capable of being ruptured; and

(c) a triggering source to rupture the micro-needles when activated to deliver the biologically active material from the interior compartment of the balloon through the micro-needle lumens to the body lumen, wherein the triggering source is selected from the group consisting of a shockwave, ultrasound energy and energy source for delivering a detachable coil.

9. The apparatus of claim 8, wherein the balloon outer surface is part of a balloon wall, and the micro-needles are disposed upon a plate attached to the balloon wall in a manner such that the micro-needles project through the balloon wall.

10. The apparatus of claim 8, wherein the triggering source is disposed at the proximal portion of the catheter.

11. The apparatus of claim 8, wherein the triggering source is a shockwave.