# US 6,638,246 B1 · 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 6,638,246 B1 - Document ID: US6638246B1 - Status: Granted - Kind: B1 - Application number: 09/724,505 - Filed: 2000-11-28 - Granted: 2003-10-28 - Earliest claimed: 2000-11-28 - Assignees: SciMed Life Systems, Inc. - Inventors: Wendy Naimark; Maria Palasis; Robbert A Herrmann - Web page: https://patentgrep.com/patent/US6638246B1 ## 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 oating 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 an outer surface, disposed at the distal portion of the catheter; and a plurality of micro-needles disposed upon the outer surface of the balloon, a sheath having an inner surface and a plurality of ports, wherein the micro-needles are capable of contacting the body lumen to deliver the biologically active material to the body lumen, and wherein said sheath surrounds the balloon in a manner such that upon expansion of the balloon, an outer surface of the balloon contacts the inner surface of the sheath and the micro-needles project through the ports. ### Claim 2 (depends on 1) The apparatus of claim 1, wherein the sheath is attached to the balloon in a manner such that the sheath expands as the balloon expands and the sheath collapses as the balloon is deflated. ### Claim 3 (depends on 1) The apparatus of claim 1, wherein the micro-needles lay along the outer surface of the balloon when the balloon is in a deflated state, and the micro-needles become erect such that they protrude from the outer surface of the balloon when the balloon is in an expanded state. ### Claim 4 (depends on 1) The apparatus of claim 1, wherein the sheath comprises a plurality of micro-needle channels that are capable of guiding the micro-needles through the ports upon expansion of the balloon. ### Claim 5 (depends on 1) The apparatus of claim 1, wherein the sheath is formed of a mesh material. ### Claim 6 (depends on 1) The apparatus of claim 1, wherein the ports of the sheath are made by being punctured by the micro-needles when the balloon is inflated. ### Claim 7 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 an outer 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, the balloon has an interior compartment for containing the biologically active material, the micro-needles each have a lumen in fluid communication with the interior compartment, the micro-needles allow the biologically active material to be delivered from the interior compartment through the lumens of the micro-needles to the body lumen, and the interior compartment containing the biologically active material is not in fluid communication with the catheter. ### Claim 8 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 an outer 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, the micro-needles are selected from the group consisting of micro-needles having an exterior surface having at least one gutter disposed along the longitudinal axis of the micro-needles to allow the biologically active material to be delivered along the gutter or micro-needles capable of being ruptured, and there are between about 1×103 and about 1×105 micro-needles per cm2 of the outer surface of the balloon upon which the micro-needles are disposed. ### Claim 9 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 an outer 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, the balloon has an interior compartment for containing the biologically active material, the micro-needles each have a lumen in fluid communication with the interior compartment, the micro-needles allow the biologically active material to be delivered from the interior compartment through the lumens of the micro-needles to the body lumen, and there are between about 1×103 and about 1×105 micro-needles per cm2 of the outer surface of the balloon upon which the micro-needles are disposed.