# US 10,369,280 B2 · Indwelling needle assembly > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,369,280 B2 - Document ID: US10369280B2 - Status: Granted - Kind: B2 - Application number: 15/526,832 - Filed: 2015-11-20 - Published: 2018-02-15 - Granted: 2019-08-06 - Earliest claimed: 2014-11-21 - Assignees: Nipro Corporation - Applicants: Nipro Corporation - Inventors: Hiroyuki Nakagami; Shingo Sakamoto; Asumi Mino - Web page: https://patentgrep.com/patent/US10369280B2 ## CPC - A61M 5/158: Needles {for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body} - A61M 5/50: having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile {(retractable needles or needle protectors with means for preventing re-use A61M5/321)} - A61M 25/06: Body-piercing guide needles or the like - A61M 25/0618: {having means for protecting only the distal tip of the needle, e.g. a needle guard} - A61M 25/0693: {Flashback chambers} - A61M 25/0014: {Connecting a tube to a hub} - A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections} - A61M 25/065: {Guide needles} - 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 In an indwelling needle assembly, a safety mechanism part is provided with an outer-needle-hub engaging part to be engaged with an outer needle hub, and an engaging-part opposing wall. Relative rotation of the outer-needle-hub engaging part and the engaging-part opposing wall is restricted, and at least one of the outer-needle-hub engaging part and the engaging-part opposing wall displaces integrally with urging parts. When an inner needle is pulled out of the outer needle hub, a block part engaged with the inner needle through an inner-needle engaging part is moved relative to the urging parts and forced to a non-contact state, and the urging parts displace in a direction approaching the inner needle, thereby preventing a needle tip of the inner needle from protruding from the safety mechanism part and releasing engagement of the outer needle hub with the safety mechanism part. ## Claims ### Claim 1 An indwelling needle assembly comprising: an outer needle hub; an inner needle inserted into the outer needle hub; and a safety mechanism part externally mounted about the inner needle and is configured to protect a needle tip of the inner needle when the inner needle is pulled out of the outer needle hub, wherein the safety mechanism part includes at least one urging part urged in a direction of approaching the inner needle and a block part that is in contact with the urging part such that the urging part is kept remote from the inner needle, the block part includes an inner-needle engaging part that is engaged with the inner needle in an axial direction and a peripheral wall part on which the urging part is held in contact and being disposed about the inner needle with a radial space therebetween so that the peripheral wall part is radially spaced away from the inner needle, and the urging part and the block part are movable relative to each other in a lengthwise direction of the inner needle, the safety mechanism part further includes an outer-needle-hub engaging part that is engaged with an outer surface of the outer needle hub and an engaging-part opposing wall that is positioned in opposition to the outer-needle-hub engaging part and limits displacement of the outer needle hub in a direction of disengagement from the outer-needle-hub engaging part by being in contact with the outer needle hub, and relative rotation of the outer-needle-hub engaging part and the engaging-part opposing wall around the inner needle is restricted, at least one of the outer-needle-hub engaging part and the engaging-part opposing wall is configured to displace integrally with the urging part, and by the inner needle being pulled out of the outer needle hub, the block part engaged with the inner needle by the inner-needle engaging part is configured to move relative to the urging part to be in a state of non-contact, while the urging part is configured to displace in the direction of approaching the inner needle such that the needle tip of the inner needle is prevented from protruding from the safety mechanism part and engagement of the outer needle hub with the safety mechanism part is allowed to be released. ### Claim 2 (depends on 1) The indwelling needle assembly according to claim 1, wherein the engaging-part opposing wall extends to an inside of the outer needle hub. ### Claim 3 (depends on 2) The indwelling needle assembly according to claim 2, wherein the outer-needle-hub engaging part includes on an inner surface thereof a sloping part that gradually slopes in the direction of approaching the inner needle towards a distal end side in a needle axis direction. ### Claim 4 (depends on 1) The indwelling needle assembly according to claim 1, wherein the safety mechanism part further includes an outside tube part in which the urging part is inserted, and one of the outer-needle-hub engaging part and the engaging-part opposing wall is integrally provided with the outside tube part, while another of the outer-needle-hub engaging part and the engaging-part opposing wall is configured to displace integrally with the urging part. ### Claim 5 (depends on 4) The indwelling needle assembly according to claim 4, wherein the outside tube part includes a rotation restricting part that restricts rotation relative to the urging part, and the rotation restricting part restricts the rotation of the outside tube part relative to the urging part while limiting disengagement of the outside tube part from the outer needle hub. ### Claim 6 (depends on 1) The indwelling needle assembly according to claim 1, wherein by the inner needle being pulled out of the outer needle hub, the urging part is configured to displace onto a needle axis of the inner needle such that the needle tip of the inner needle is prevented from protruding from the safety mechanism part. ### Claim 7 An indwelling needle assembly comprising: an outer needle hub; an inner needle inserted into the outer needle hub; and a safety mechanism part externally mounted about the inner needle and is configured to protect a needle tip of the inner needle when the inner needle is pulled out of the outer needle hub, wherein the safety mechanism part includes at least one urging part urged in a direction of approaching the inner needle and a block part that is in contact with the urging part such that the urging part is kept remote from the inner needle, the block part includes an inner-needle engaging part that is engaged with the inner needle in an axial direction, and the urging part and the block part are movable relative to each other in a lengthwise direction of the inner needle, the safety mechanism part further includes an outer-needle-hub engaging part that is engaged with an outer surface of the outer needle hub and an engaging-part opposing wall that is positioned in opposition to the outer-needle-hub engaging part and limits displacement of the outer needle hub in a direction of disengagement from the outer-needle-hub engaging part by being in contact with the outer needle hub, and relative rotation of the outer-needle-hub engaging part and the engaging-part opposing wall around the inner needle is restricted, at least one of the outer-needle-hub engaging part and the engaging-part opposing wall is configured to displace integrally with the urging part, by the inner needle being pulled out of the outer needle hub, the block part engaged with the inner needle by the inner-needle engaging part is configured to move relative to the urging part to be in a state of non-contact, while the urging part is configured to displace in the direction of approaching the inner needle such that the needle tip of the inner needle is prevented from protruding from the safety mechanism part and engagement of the outer needle hub with the safety mechanism part is allowed to be released, the engaging-part opposing wall extends to an inside of the outer needle hub, and the engaging-part opposing wall is made of synthetic resin. ### Claim 8 An indwelling needle assembly comprising: an outer needle hub; an inner needle inserted into the outer needle hub; and a safety mechanism part externally mounted about the inner needle and is configured to protect a needle tip of the inner needle when the inner needle is pulled out of the outer needle hub, wherein the safety mechanism part includes at least one urging part urged in a direction of approaching the inner needle and a block part that is in contact with the urging part such that the urging part is kept remote from the inner needle, the block part includes an inner-needle engaging part that is engaged with the inner needle in an axial direction, and the urging part and the block part are movable relative to each other in a lengthwise direction of the inner needle, the safety mechanism part further includes an outer-needle-hub engaging part that is engaged with an outer surface of the outer needle hub and an engaging-part opposing wall that is positioned in opposition to the outer-needle-hub engaging part and limits displacement of the outer needle hub in a direction of disengagement from the outer-needle-hub engaging part by being in contact with the outer needle hub, and relative rotation of the outer-needle-hub engaging part and the engaging-part opposing wall around the inner needle is restricted, at least one of the outer-needle-hub engaging part and the engaging-part opposing wall is configured to displace integrally with the urging part, by the inner needle being pulled out of the outer needle hub, the block part engaged with the inner needle by the inner-needle engaging part is configured to move relative to the urging part to be in a state of non-contact, while the urging part is configured to displace in the direction of approaching the inner needle such that the needle tip of the inner needle is prevented from protruding from the safety mechanism part and engagement of the outer needle hub with the safety mechanism part is allowed to be released, and the engaging-part opposing wall is engaged with the outer surface of the outer needle hub. ### Claim 9 (depends on 8) The indwelling needle assembly according to claim 8, wherein the at least one urging part comprises a pair of urging parts provided in opposition to each other, the outer-needle-hub engaging part continuously extends from one of the urging parts positioned on an opposite side thereof with the inner needle being interposed therebetween, while the engaging-part opposing wall continuously extends from another of the urging parts positioned on an opposite side thereof with the inner needle being interposed therebetween, and by the pair of urging parts displacing in the direction of approaching the inner needle, the outer-needle-hub engaging part and the engaging-part opposing wall are configured to displace with respect to the outer needle hub in a direction of separation from the inner needle such that engagement of the outer-needle-hub engaging part and the engaging-part opposing wall with the outer surface of the outer needle hub is released. ### Claim 10 An indwelling needle assembly comprising: an outer needle hub; an inner needle inserted into the outer needle hub; a safety mechanism part externally mounted about the inner needle and is configured to protect a needle tip of the inner needle when the inner needle is pulled out of the outer needle hub; and a plate spring, wherein the safety mechanism part includes at least one urging part urged in a direction of approaching the inner needle and a block part that is in contact with the urging part such that the urging part is kept remote from the inner needle, the block part includes an inner-needle engaging part that is engaged with the inner needle in an axial direction, and the urging part and the block part are movable relative to each other in a lengthwise direction of the inner needle, the safety mechanism part further includes an outer-needle-hub engaging part that is engaged with an outer surface of the outer needle hub and an engaging-part opposing wall that is positioned in opposition to the outer-needle-hub engaging part and limits displacement of the outer needle hub in a direction of disengagement from the outer-needle-hub engaging part by being in contact with the outer needle hub, and relative rotation of the outer-needle-hub engaging part and the engaging-part opposing wall around the inner needle is restricted, at least one of the outer-needle-hub engaging part and the engaging-part opposing wall is configured to displace integrally with the urging part, by the inner needle being pulled out of the outer needle hub, the block part engaged with the inner needle by the inner-needle engaging part is configured to move relative to the urging part to be in a state of non-contact, while the urging part is configured to displace in the direction of approaching the inner needle such that the needle tip of the inner needle is prevented from protruding from the safety mechanism part and engagement of the outer needle hub with the safety mechanism part is allowed to be released, and the urging part is made of synthetic resin at least in a portion that is in contact with the block part, and the portion made of synthetic resin is urged by the plate spring in the direction of approaching the inner needle. ### Claim 11 (depends on 10) The indwelling needle assembly according to claim 10, wherein the safety mechanism part further includes an urging-part opposing wall that is provided integrally with the urging part and positioned mutually in opposition to the urging part with the inner needle being interposed therebetween, the plate spring is made of metal and has a U-letter shape, the urging part and the urging-part opposing wall have respective guiding grooves on outer surfaces thereof, and distal end portions of the plate spring, which are on an opening side of the plate spring, are inserted into the respective guiding grooves such that the urging part and the urging-part opposing wall are urged in the direction of approaching the inner needle. ### Claim 12 (depends on 10) The indwelling needle assembly according to claim 10, wherein the plate spring is made of metal and has a U-letter shape, and distal end portions of the plate spring extend toward a proximal end side in a needle axis direction. ### Claim 13 An indwelling needle assembly comprising: an outer needle hub; an inner needle inserted into the outer needle hub; and a safety mechanism part externally mounted about the inner needle and is configured to protect a needle tip of the inner needle when the inner needle is pulled out of the outer needle hub, wherein the safety mechanism part includes at least one urging part urged in a direction of approaching the inner needle and a block part that is in contact with the urging part such that the urging part is kept remote from the inner needle, the block part includes an inner-needle engaging part that is engaged with the inner needle in an axial direction, and the urging part and the block part are movable relative to each other in a lengthwise direction of the inner needle, the safety mechanism part further includes an outer-needle-hub engaging part that is engaged with an outer surface of the outer needle hub and an engaging-part opposing wall that is positioned in opposition to the outer-needle-hub engaging part and limits displacement of the outer needle hub in a direction of disengagement from the outer-needle-hub engaging part by being in contact with the outer needle hub, and relative rotation of the outer-needle-hub engaging part and the engaging-part opposing wall around the inner needle is restricted, at least one of the outer-needle-hub engaging part and the engaging-part opposing wall is configured to displace integrally with the urging part, by the inner needle being pulled out of the outer needle hub, the block part engaged with the inner needle by the inner-needle engaging part is configured to move relative to the urging part to be in a state of non-contact, while the urging part is configured to displace in the direction of approaching the inner needle such that the needle tip of the inner needle is prevented from protruding from the safety mechanism part and engagement of the outer needle hub with the safety mechanism part is allowed to be released, and the block part has a plate shape. ### Claim 14 An indwelling needle assembly comprising: an outer needle hub; an inner needle inserted into the outer needle hub; and a safety mechanism part externally mounted about the inner needle and is configured to protect a needle tip of the inner needle when the inner needle is pulled out of the outer needle hub, wherein the safety mechanism part includes at least one urging part urged in a direction of approaching the inner needle and a block part that is in contact with the urging part such that the urging part is kept remote from the inner needle, the block part includes an inner-needle engaging part that is engaged with the inner needle in an axial direction, and the urging part and the block part are movable relative to each other in a lengthwise direction of the inner needle, the safety mechanism part further includes an outer-needle-hub engaging part that is engaged with an outer surface of the outer needle hub and an engaging-part opposing wall that is positioned in opposition to the outer-needle-hub engaging part and limits displacement of the outer needle hub in a direction of disengagement from the outer-needle-hub engaging part by being in contact with the outer needle hub, and relative rotation of the outer-needle-hub engaging part and the engaging-part opposing wall around the inner needle is restricted, at least one of the outer-needle-hub engaging part and the engaging-part opposing wall is configured to displace integrally with the urging part, by the inner needle being pulled out of the outer needle hub, the block part engaged with the inner needle by the inner-needle engaging part is configured to move relative to the urging part to be in a state of non-contact, while the urging part is configured to displace in the direction of approaching the inner needle such that the needle tip of the inner needle is prevented from protruding from the safety mechanism part and engagement of the outer needle hub with the safety mechanism part is allowed to be released, and the urging part includes a needle restricting part that is configured to come into contact with a side surface of the inner needle, and by the inner needle being pulled out of the outer needle hub, the needle restricting part is configured to come into contact with the side surface of the inner needle such that the needle tip of the inner needle is prevented from protruding from the safety mechanism part. ### Claim 15 (depends on 14) The indwelling needle assembly according to claim 14, wherein the needle restricting part is configured to be engaged with either one of a convex part and a concave part formed on an outer circumferential surface of the inner needle by the inner needle being pulled out of the outer needle hub. ### Claim 16 (depends on 14) The indwelling needle assembly according to claim 14, wherein the safety mechanism part further includes a reinforcing part that is configured to limit flexure of the needle restricting part in a position to which the urging part displaces in the direction of approaching the inner needle. ### Claim 17 An indwelling needle assembly comprising: an outer needle hub; an inner needle inserted into the outer needle hub; and a safety mechanism part is externally mounted about the inner needle and is configured to protect a needle tip of the inner needle when the inner needle is pulled out of the outer needle hub, wherein the safety mechanism part includes an urging part urged in a direction of approaching the inner needle and a block part that is in contact with the urging part such that the urging part is kept remote from the inner needle, the block part includes an inner-needle engaging part that is engaged with the inner needle in an axial direction and a peripheral wall part on which the urging part is held in contact and being disposed about the inner needle with a radial space therebetween so that the peripheral wall part is radially spaced away from the inner needle, and the urging part and the block part are movable relative to each other in a lengthwise direction of the inner needle, the outer needle hub is provided with an engaging projection on an outer surface thereof, the safety mechanism part further includes an outer-needle-hub engaging part that is engaged with the engaging projection and an engaging-part opposing wall that limits disengaging displacement of the outer-needle-hub engaging part radially outward from the engaging projection by coming into contact with an inner surface of the outer needle hub, an amount of displacement to be limited by the engaging-part opposing wall coming into contact with the inner surface of the outer needle hub is set so as not to reach an amount of displacement required for disengagement of the outer-needle-hub engaging part radially outward from the engaging projection in every axis-perpendicular direction of the outer needle hub, at least one of the outer-needle-hub engaging part and the engaging-part opposing wall is configured to displace integrally with the urging part, and by the inner needle being pulled out of the outer needle hub, the block part engaged with the inner needle by the inner-needle engaging part is configured to move relative to the urging part to be in a state of non-contact, while the urging part is configured to displace in the direction of approaching the inner needle such that the needle tip of the inner needle is prevented from protruding from the safety mechanism part and engagement of the outer needle hub with the safety mechanism part is allowed to be released. ### Claim 18 (depends on 17) The indwelling needle assembly according to claim 17, wherein the engaging-part opposing wall has a curving surface shape in a portion that is configured to come into contact with the inner surface of the outer needle hub.