# US 7,569,032 B2 · Medical device for delivery of a biologically active material to a lumen > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,569,032 B2 - Document ID: US7569032B2 - Status: Granted - Kind: B2 - Application number: 10/645,652 - Filed: 2003-08-20 - Published: 2004-03-04 - Granted: 2009-08-04 - Earliest claimed: 2000-11-28 - Assignees: Boston Scientific Scimed, Inc. - Inventors: Wendy Naimark; Maria Palasis; Robbert A Herrmann - Web page: https://patentgrep.com/patent/US7569032B2 ## CPC - A61M 37/0015: {by using microneedles} - 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}) - 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) - A61M 2025/0093: {wherein at least one needle is a microneedle} - A61M 2025/1013: {with concentrically mounted balloons, e.g. being independently inflatable} - A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes} - A61M 2025/1072: {having balloons with two or more compartments} - 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} - A61M 2025/1086: {having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves} - B33Y 80/00: Products made by additive manufacturing - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - B33Y: ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING ## 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 ### Claim 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. ### Claim 2 (depends on 1) 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. ### Claim 3 (depends on 1) The apparatus of claim 1, wherein the plate is solid. ### Claim 4 (depends on 1) The apparatus of claim 1, wherein the plate is porous. ### Claim 5 (depends on 1) 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. ### Claim 6 (depends on 1) The apparatus of claim 1, wherein the biologically active material is contained in the layer of the balloon wall. ### Claim 7 (depends on 1) 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. ### Claim 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. ### Claim 9 (depends on 8) 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. ### Claim 10 (depends on 8) The apparatus of claim 8, wherein the triggering source is disposed at the proximal portion of the catheter. ### Claim 11 (depends on 8) The apparatus of claim 8, wherein the triggering source is a shockwave.