# US 10,945,759 B2 · Microneedle device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,945,759 B2 - Document ID: US10945759B2 - Status: Granted - Kind: B2 - Application number: 15/857,491 - Filed: 2017-12-28 - Published: 2019-07-04 - Granted: 2021-03-16 - Earliest claimed: 2017-12-28 - Assignees: Refine USA, LLC - Applicants: Refine USA, LLC - Inventors: Brian Smith; Anthony A. Johnson - Web page: https://patentgrep.com/patent/US10945759B2 ## CPC - A61B 17/34: Trocars; Puncturing needles - A61M 37/0015: {by using microneedles} - A61B 17/205: {Vaccinating by means of needles or other puncturing devices} - A61B 2017/00367: {Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like} - A61B 2017/00761: {Removing layer of skin tissue, e.g. wrinkles, scars or cancerous tissue} - A61M 2037/0023: {Drug applicators using microneedles} - A61M 2037/0061: {Methods for using microneedles} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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)} ## Abstract A microneedle device includes an elastic sleeve to provide a biasing force and also to provide a fluid impermeable seal. The biasing force urges a barrel from the extended position to the retracted position. As a seal, the sleeve prevents contamination by fluids that may enter the barrel. Additionally, the distal end of the barrel features an undulating (waveform-like) formation to prevent suction buildup between the barrel and a patient's skin. ## Claims ### Claim 1 A microneedle device comprising: a sleeve having a proximal end and a distal end, the proximal end of the sleeve being open, the distal end of the sleeve being open, a central channel extending through the sleeve from the proximal end of the sleeve to the distal end of the sleeve, the sleeve being elastic and stretchable from a relaxed length to a stretched length, and at the stretched length the sleeve exerting a tensile force, the tensile force urging return of the sleeve to the relaxed length, and the sleeve providing a fluid tight seal between the rod and the plunger; and a rod having a proximal end, a medial portion, a distal end, a proximal portion extending from the medial portion of the rod to the proximal end of the rod, and a distal portion extending from the medial portion to the distal end of the rod; the distal portion of the rod extending through the central channel of the sleeve, and the rod being movable linearly in reciprocating fashion relative to the proximal end of the sleeve, reciprocating motion of the rod being between a retracted position and an extended position; and a barrel having a proximal end and a distal end, the proximal end of the barrel being open, the distal end of the barrel being open, and a central channel extending through the barrel from the distal end of the barrel to the proximal end of the barrel, and the barrel being rigid; and a plunger having a proximal end, a distal end, and a body between the distal end of the plunger and the proximal end of the plunger, the distal end of the plunger including a substantially planar surface, the body of the plunger being sized and shaped to fit within the central channel of the barrel and allow reciprocating linear motion of the plunger in the barrel, and the distal end of the rod being coupled to the proximal end of the plunger, and reciprocating motion of the rod being between the retracted position and the extended position causing equal reciprocating motion of the plunger, and the distal end of the elastic sleeve being coupled to the proximal end of the plunger; and a plurality of needles attached to and extending from the distal end of the plunger, the plurality of needles being contained within the central channel of the barrel when the rod is in the retracted position, and the plurality of needles extending beyond the distal end of the barrel when the rod is in the extended position. ### Claim 2 (depends on 1) The microneedle device according to claim 1, the sleeve being impermeable. ### Claim 3 (depends on 1) The microneedle device according to claim 1, the sleeve being comprised of a material from the group consisting of a medical grade rubber, a medical grade polydimethylsiloxane and a medical grade fluoropolymer elastomer. ### Claim 4 (depends on 1) The microneedle device according to claim 1, the medial portion of the rod including an annular stop, the annular stop and rod being concentric. ### Claim 5 (depends on 1) The microneedle device according to claim 1, further comprising a sleeve housing, the sleeve housing comprising a hollow elongated cylinder with a proximal end and a distal end, the proximal end of the hollow elongated cylinder being open, the distal end of the hollow elongated cylinder being open, and a central channel extending through the hollow elongated cylinder from the distal end of the hollow elongated cylinder to the proximal end of the hollow elongated cylinder, and the hollow elongated cylinder being rigid, and the hollow elongated cylinder containing at least a substantial portion of the sleeve including the proximal end of the sleeve, and the proximal end of the sleeve being coupled to the proximal end of the sleeve housing. ### Claim 6 (depends on 5) The microneedle device according to claim 5, further comprising a flanged bushing including an annular flange and a tube, the tube extending perpendicularly from the annular flange, the annular flange and the tube being concentric, and the tube being pressed within the proximal end of the sleeve within the proximal end of the sleeve housing and thereby securing the proximal end of the sleeve at the proximal end of the sleeve housing, and the flange abutting the proximal end of the sleeve housing, and the distal portion of the rod extending through the flanged bushing. ### Claim 7 (depends on 1) The microneedle device according to claim 1, the distal end of the barrel including a plurality of concave formations. ### Claim 8 (depends on 1) The microneedle device according to claim 1, the distal end of the barrel including undulating formations. ### Claim 9 (depends on 1) The microneedle device according to claim 1, the sleeve being impermeable and comprised of a material from the group consisting of a medical grade rubber, a medical grade polydimethylsiloxane and a medical grade fluoropolymer elastomer; and the medial portion of the rod including an annular stop, the annular stop and rod being concentric; and the distal end of the barrel including undulating formations; and the microneedle device further comprising a sleeve housing, the sleeve housing comprising a hollow elongated cylinder with a proximal end and a distal end, the proximal end of the hollow elongated cylinder being open, the distal end of the hollow elongated cylinder being open, and a central channel extending through the hollow elongated cylinder from the distal end of the hollow elongated cylinder to the proximal end of the hollow elongated cylinder, and the hollow elongated cylinder being rigid, and the hollow elongated cylinder containing at least a substantial portion of the sleeve including the proximal end of the sleeve, and the proximal end of the sleeve being coupled to the proximal end of the sleeve housing; and a flanged bushing including an annular flange and a tube, the tube extending perpendicularly from the annular flange, the annular flange and the tube being concentric, and the tube being pressed within the proximal end of the sleeve within the proximal end of the sleeve housing and thereby securing the proximal end of the sleeve at the proximal end of the sleeve housing, and the flange abutting the proximal end of the sleeve housing, and the distal portion of the rod extending through the flanged bushing. ### Claim 10 A microneedle device comprising: a barrel having a proximal end and a distal end, the proximal end of the barrel being open, the distal end of the barrel being open, and a central channel extending through the barrel from the distal end of the barrel to the proximal end of the barrel, and the distal end of the barrel including a plurality of concave formations, and the barrel being rigid; and a plunger having a proximal end, a distal end, and a body between the distal end of the plunger and the proximal end of the plunger, the distal end of the plunger including a substantially planar surface, the body of the plunger being sized and shaped to fit within the central channel of the barrel and allow reciprocating linear motion of the plunger in the barrel; and a rod having a proximal end, a medical portion, a distal end, a proximal portion extending from the medial portion of the rod to the proximal end of the rod, and a distal portion extending from the medial portion to the distal end of the rod; the rod being movable linearly in reciprocating fashion relative to the proximal end of the barrel, reciprocating motion of the rod being between a retracted position and an extended position, and the distal end of the rod being coupled to the proximal end of the plunger, and reciprocating motion of the rod being between the retracted position and the extended position causing equal reciprocating motion of the plunger; and a biasing means coupled to the plunger, the biasing means urging the plunger, and the rod coupled to the proximal end of the plunger, towards the retracted position; and a plurality of needles attached to and extending from the distal end of the plunger, the plurality of needles being contained within the central channel of the barrel when the rod is in the retracted position, and the plurality of needles extending beyond the distal end of the barrel when the rod in the extended position; and the biasing means comprising a sleeve having a proximal end and a distal end, the proximal end of the sleeve being open, the distal end of the sleeve being open, a central channel extending through the sleeve from the proximal end of the sleeve to the distal end of the sleeve, the sleeve being elastic and stretchable from a relaxed length to a stretched length, and at the stretched length the sleeve exerting a tensile force, the tensile force urging return of the sleeve to the relaxed length, and the sleeve providing a fluid tight seal between the rod and the plunger. ### Claim 11 (depends on 10) The microneedle device according to claim 10, the sleeve being impermeable. ### Claim 12 (depends on 10) The microneedle device according to claim 10, the sleeve being comprised of a material from the group consisting of a medical grade rubber, a medical grade polydimethylsiloxane and a medical grade fluoropolymer elastomer. ### Claim 13 (depends on 10) The microneedle device according to claim 10, further comprising a sleeve housing, the sleeve housing comprising a hollow elongated cylinder with a proximal end and a distal end, the proximal end of the hollow elongated cylinder being open, the distal end of the hollow elongated cylinder being open, and a central channel extending through the hollow elongated cylinder from the distal end of the hollow elongated cylinder to the proximal end of the hollow elongated cylinder, and the hollow elongated cylinder being rigid, and the hollow elongated cylinder containing at least a substantial portion of the sleeve including the proximal end of the sleeve, and the proximal end of the sleeve being coupled to the proximal end of the sleeve housing. ### Claim 14 (depends on 13) The microneedle device according to claim 13, further comprising a flanged bushing including an annular flange and a tube, the tube extending perpendicularly from the annular flange, the annular flange and the tube being concentric, and the tube being pressed within the proximal end of the sleeve within the proximal end of the sleeve housing and thereby securing the proximal end of the sleeve at the proximal end of the sleeve housing, and the flange abutting the proximal end of the sleeve housing, and the distal portion of the rod extending through the fanged bushing. ### Claim 15 (depends on 10) The microneedle device according to claim 10, the concave formations at the distal end of the barrel being part of an undulating formation. ### Claim 16 A microneedle device comprising: a sleeve having a proximal end and a distal end, the proximal end of the sleeve being open, the distal end of the sleeve being open, a central channel extending through the sleeve from the proximal end of the sleeve to the distal end of the sleeve, the sleeve being elastic and stretchable from a relaxed length to a stretched length, and at the stretched length the sleeve exerting a tensile force, the tensile force urging return of the sleeve to the relaxed length, and the sleeve providing a fluid tight seal between the rod and the plunger; and a reciprocating rod having a proximal end, a medial portion, a distal end, a proximal portion extending from the medial portion of the reciprocating rod to the proximal end of the reciprocating rod, and a distal portion extending from the medial portion to the distal end of the reciprocating rod; the distal portion of the reciprocating rod extending through the central channel of the sleeve, and the reciprocating rod undergoing reciprocating motion relative to the proximal end of the sleeve, the reciprocating motion of the reciprocating rod being between a retracted position and an extended position; and a barrel having a proximal end and a distal end, the proximal end of the barrel being open, the distal end of the barrel being open, and a central channel extending through the barrel from the distal end of the barrel to the proximal end of the barrel, and the barrel being rigid; and a plunger having a proximal end, a distal end, and a body between the distal end of the plunger and the proximal end of the plunger, the distal end of the plunger including a substantially planar surface, the body of the plunger being sized and shaped to fit within the central channel of the barrel and allow reciprocating linear motion of the plunger in the barrel, and the distal end of the reciprocating rod being coupled to the proximal end of the plunger, and reciprocating motion of the reciprocating rod being between the retracted position and the extended position causing equal reciprocating motion of the plunger, and the distal end of the elastic sleeve being coupled to the proximal end of the plunger, and a plurality of needles attached to and extending from the distal end of the plunger, the plurality of needles being contained within the central channel of the barrel when the reciprocating rod is in the retracted position, and the plurality of needles extending beyond the distal end of the barrel when the reciprocating rod is in the extended position. ### Claim 17 (depends on 16) The microneedle device according to claim 16, further comprising a sleeve housing, the sleeve housing comprising a hollow elongated cylinder with a proximal end and a distal end, the proximal end of the hollow elongated cylinder being open, the distal end of the hollow elongated cylinder being open, and a central channel extending through the hollow elongated cylinder from the distal end of the hollow elongated cylinder to the proximal end of the hollow elongated cylinder, and the hollow elongated cylinder being rigid, and the hollow elongated cylinder containing at least a substantial portion of the sleeve including the proximal end of the sleeve, and the proximal end of the sleeve being coupled to the proximal end of the sleeve housing; and a flanged bushing including an annular flange and a tube, the tube extending perpendicularly from the annular flange, the annular flange and the tube being concentric, and the tube being pressed within the proximal end of the sleeve within the proximal end of the sleeve housing and thereby securing the proximal end of the sleeve at the proximal end of the sleeve housing, and the flange abutting the proximal end of the sleeve housing, and the distal portion of the reciprocating rod extending through the flanged bushing. ### Claim 18 (depends on 17) The microneedle device according to claim 17, the distal end of the barrel including an undulating formation.