• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    Needle Retraction Apparatus There is described a needle retraction apparatus comprising a body with a forwardly projecting needle, a needle retraction mechanism seated within the body and biasing the needle rearwardly with respect to the body, a sliding member attachable to the body. body and with an opening communicating with a needle retraction cavity protruding out of the body, and an actuator rotatable relative to the slide member for repositioning the slide member from a first position that prevents needle retraction to a second position that allows needle retraction. an iv catheter introducer comprising the subject needle retraction apparatus is also disclosed.
    公开号:BR112014025035B1
    申请号:R112014025035-9
    申请日:2013-11-27
    公开日:2021-07-13
    发明作者:Thomas J. Shaw；Mark Small；Ni Zhu
    申请人:Retractable Technologies, Inc.；Thomas J. Shaw；
    IPC主号:
    专利说明:

    CROSS REFERENCE TO RELATED ORDER
    [0001] This application claims the benefit of provisional US patent application No. 61/737,263, filed December 14, 2012. This application is also a continuation in part of US patent application No. 12/846,402, filed 29 of July 2010, as Order No. 12/846,402 discloses a trigger or actuator that contacts and moves an ear along an arc defined by a rotatable ear ring whose movement aligns a shaped opening with a flange correspondingly shaped on the needle holder to facilitate needle retraction. FUNDAMENTALS OF THE INVENTION 1. Field of invention
    [0002] This invention relates to a safety needle retraction apparatus for medical devices and, more particularly, to an unprecedented safety needle retraction apparatus that is part of a catheter introducer for intravenous or other biomedical applications, or as part of another device suitable for other infusion or fluid collection procedures.
    [0003] One aspect of the invention concerns an IV catheter introducer with a needle retraction apparatus that is rotationally activated. Another aspect of the invention relates to a needle retraction apparatus for a glass or plastic liquid infusion or collection device, the apparatus having a body, a needle retraction mechanism, and a rearward-facing forward-facing needle. .
    [0004] Another aspect of the invention is a retractable needle apparatus that is also adapted to be used with a conventional catheter hub and cannula that are attachable to the front of the apparatus.
    [0005] Another aspect of the invention concerns a rear slide assembly with a flash chamber and a laterally spaced and substantially parallel needle retraction tube. The rear slide assembly is adapted to move transversely to the body as the needle retraction tube is rotated relative to the body to initiate needle retraction after fluid collection or infusion.
    [0006] Another aspect of the invention relates to a method for retracting a needle into a medical device whereby rotation of a needle retraction tube causes the needle retraction tube to be repositioned laterally into coaxial alignment with a needle rearwardly biased to facilitate retraction of the needle into the needle retraction tube. 2. Description of Related Art
    [0007] Popov U.S. Publication No. 2006/0155244 discloses a venipuncture device that rotates a port unit after needle retraction. The needle retraction chamber is disposed within the medical device and remains stable while the port unit is rotationally moved relative to the retraction chamber after needle retraction. The front attachment revealed therein cannot be used with a generic luer lock syringe.
    [0008] Although many advances in medical safety technology have been made in recent years, a retractable needle apparatus is needed that can be used in combination with other commercially available fluid collection or infusion devices such as the IV catheter introducer here described. Such a device will desirably have a needle retraction chamber external to the fluid flow path and will offer the advantages of a retractable needle with sufficient retraction force. SUMMARY OF THE INVENTION
    [0009] There is disclosed a needle retraction apparatus comprising a body, a sliding member attachable to the back of the body, a needle retraction mechanism seated within the body, a fluid seal seated between the body and the sliding member , and a medical grade stainless steel needle (or approved equivalent) projecting to the front of the body. In accordance with an embodiment of the invention, the body comprises a centrally disposed stepped axial bore, laterally projecting gripping surfaces, and a forwardly projecting nose to which a conventional catheter hub and cannula are releasably attachable.
    [00010] According to an embodiment of the invention, the sliding member comprises a forward-facing surface that is configured to support and move transversely in sliding relation to the rear of the housing during the needle retraction process. In one embodiment, the rear of the body comprises upper and lower tracks that slidingly engage the main transverse portion of the slide member. The sliding member desirably further comprises two laterally spaced openings, one of which serves as an opening for a flash chamber projecting rearwardly beyond the forward facing surface, and another of which serves as an opening for a needle retraction tube. rearward projecting that is substantially parallel to, but spaced laterally from, the lightning chamber.
    [00011] The flash chamber is desirably initially aligned with the needle holder, and is preferably transparent or sufficiently translucent that medical personnel using the device can easily determine if vascular access has been achieved during insertion. A polymeric plug or other suitable apparatus is desirably installed at the rear of the flash chamber to facilitate the infusion or collection of fluid through the flash chamber. The plug can be pierceable or it can be provided with a continuous hole to facilitate connection to another fluid collection or infusion device.
    [00012] The needle retraction tube is desirably supported by the slide element, but is rotatable relative to the slide element, to facilitate lateral repositioning of the needle retraction tube during the needle retraction process. In accordance with an embodiment of the invention, the needle retraction tube desirably has an open front end and a closed rear end, and comprises an annular flange disposed about the open end. The annular flange preferably comprises a forwardly projecting ear which is received in a cooperatively aligned positioning notch in the body during assembly. As the needle retraction tube is rotated to initiate needle retraction, the forward projecting ear moves arcuately around the longitudinal axis of the retraction tube and engages the sides of the repositioning notch in the body, which causes the slider moves transversely with respect to the body, thereby placing the needle retraction tube in substantially coaxial alignment with the needle holder and the needle.
    [00013] According to an embodiment of the invention, the needle retraction mechanism comprises an elongated needle holder that can be received in the axial bore of the body and captures a retraction spring compressed within the body. Other devices similarly effective to predispose the needle holder and needle back can also be used. The needle support is desirably limited within the housing prior to retraction of the needle by the confronting and sliding member, and a fluid seal is desirably disposed between the rearwardly facing head of the needle support and a forwardly facing annular recess in the opening for inside the lightning chamber.
    [00014] The needle retraction apparatus of the invention may be provided separately or in combination with the catheter hub, but is desirably provided with the catheter hub already installed in the body. In accordance with a satisfactory method of using the invention, the protective cap (not shown) is removed from the front of the needle and catheter hub and, with the ear projecting to the front of the needle retraction tube, positioning the flash chamber in alignment substantially coaxial with the needle holder and needle, the needle is inserted into a patient. If blood appears in the flash chamber, this means successful vascular insertion. The needle can be retracted from the cannula and into the instrument by rotating the needle retraction tube relative to the body to reposition the needle retraction tube in coaxial alignment with the needle holder. Once the coaxial alignment point is reached, the rearwardly biased needle holder is pushed back into a retraction cavity within the needle retraction tube. At this point, the catheter hub is available for connection to another device such as an IV set. BRIEF DESCRIPTION OF THE DRAWINGS
    [00015] The apparatus of the invention is further described and explained in relation to the following drawings, in which:
    [00016] Figure 1 is a top plan view of an embodiment of an apparatus of the invention with the needle projecting forward from the needle hub of the apparatus in coaxial alignment with the flash chamber tube of the apparatus;
    [00017] Figure 2 is a side elevation view of the embodiment of Figure 1;
    [00018] Figure 3 is a transverse sectional side elevation view taken along line 3 - 3 of figure 1;
    [00019] Figure 4 is an exploded front perspective view of the embodiment of figure 1;
    [00020] Figure 5 is a top cross-sectional plan view of the embodiment of Figure 1 after needle retraction and with the needle retraction tube repositioned in coaxial alignment with the needle hub;
    [00021] Figure 6 is a side elevation view of the embodiment of Figure 5; and
    [00022] Figure 7 is a cross-sectional side elevation of the embodiment of Figure 1 showing the needle holder and at least a portion of the needle and retraction spring retracted into the needle retraction cavity;
    [00023] Figure 8 is a rear elevation view of the apparatus of Figure 1;
    [00024] Figures 9 and 10 are rear elevation views of the device in figure ! wherein the needle retraction tube has been rotated sufficiently to cause the rear slide assembly to begin repositioning the needle retraction tube into coaxial alignment with the needle holder; and
    [00025] Figure 11 is a rear elevation view of the apparatus of figure 1 with the needle retraction tube completely repositioned to the retraction position. DESCRIPTION OF THE PREFERRED MODALITIES
    [00026] Figures 1-4 reveal an IV catheter introducer 30 comprising the needle retraction apparatus of the invention, which further comprises a body 34, forwardly projecting needle 78 (figure 4) with beveled tip 94, mechanism of needle retraction 36, slider 38, and needle retraction tube 42. Referring to Figures 1-4, catheter hub assembly 32 is a conventional IV catheter hub that is releasably attachable to body 34 and includes a forward-facing flexible sheath or cannula 44 through which needle 78 is inserted to facilitate vascular insertion. The needle retraction mechanism 36 is seated within the body 34, and is held in place by the slider 38 (figure 4) into which the needle retraction tube 42 is inserted before being slidably fitted with the rear of the body. 34 during assembly. Those skilled in the art also realize, upon reading this disclosure, that the needle retraction apparatus of the invention is readily adaptable for use with other medical devices in which a retractable needle and rotationally activated needle retraction mechanism are desired.
    [00027] As shown, the catheter hub 32 further comprises hub nose 46 projecting forward from the substantially cylindrical barrel 48 which also has a rear opening surrounded by the annular attachment collar 50 comprising opposing ears 52, 54. The collar interior of annular attachment 50 and barrel 48 desirably comprises a conical female luer surface configured to provide frictional fluid tight fit with the forwardly projecting male luer tip 56 of body 34.
    [00028] The body 34 comprises a stepped inner surface (figure 3) and has outer grip surfaces 58 desirably configured to be easily gripped by a clinician during vascular insertion. The rear portion of body 34 preferably comprises upper track 60 and laterally extending lower track 62 which are desirably configured to slidingly engage and retain the forwardly facing frame 80 of slide member 38 in close proximity to body 34. positioning notch 64 is desirably provided at the rear of body 34 to facilitate engagement with the forwardly projecting ear 102 of needle retraction tube 42 as described further below in connection with operation of the device.
    [00029] Needle retraction mechanism 36 comprising needle holder 70 and spring 76 (shown in its compressed state to save space for illustrative purposes in Figure 4, rather than in the relaxed state shown in Figure 7) is desirably seated within the stepped cylindrical body 34. The needle holder 70 shown comprises an elongated cylindrical shaft 72 and a head having a diameter 74. The outer diameter of the shaft 72 is desirably slightly smaller than the inner diameter of the coil spring 76 to allow insertion of the shaft 72 through the spiral spring. A continuous axial bore 92 desirably extends through shaft 72 and head 74 of needle holder 70. The outer diameter of head 74 is desirably sufficiently larger than shaft 72 to provide a forwardly facing annular surface at the rear end. of shaft 72 on which the rear end of spring 76 bears when compressed and installed within body 34. The rearward facing end of head 74 of needle holder 70 may comprise a slight recess to facilitate seating of fluid seal 68 , although the fluid seal 68 is desirably carried by the slider 38 during needle retraction, as discussed below. Compressed spring 76 biases needle holder 70 rearwardly with respect to body 34, and needle holder 70 is retained within body 34 against biasing the spring by slider 38 when slider 38 is mounted to body 34. While spring 76 is satisfactory for use in biasing the needle holder back with respect to body 34, other similarly effective configurations may also be used. During assembly of the needle retraction apparatus in question, the rearwardly blunt tip of needle 78 (figure 4) is desirably inserted into hole 92 of needle holder 70 from the front and is attached in fixed relation to needle holder 70 by any suitable known device, such as by glue or the like.
    The slider 38 desirably comprises the frame 80 and the substantially cylindrical, rearwardly projecting fluid flash chamber 110 with an interior space in which fluid can flow from a patient through the needle 78, needle holder 70 and opening 90. Elastomeric plug 40 is desirably fitted in a rearwardly facing flash chamber opening 110. The forwardly facing portion of slider 38 desirably comprises first and second circular apertures including apertures 90, 86, respectively. The opening 90 is provided rearwardly by the annular recess 88 in the forwardly facing surface 84. The annular recess 88 is provided to seat the fluid seal 68, which is preferably an elastomeric O-ring disposed between the head 74 of the needle holder. 70 and slide 38 for preventing fluid leakage during use and prior to needle retraction. Aperture 86 is provided in the recessed surface section 82 to facilitate assembly of the needle retraction tube 42 with the slider 38.
    [00031] The needle retraction tube 42 desirably comprises a first tubular section 104 with a forwardly facing open end 98 surrounded by a radially projecting annular collar 100, and a second tubular section 108 with a closed end 106 projecting outwardly from the body 34. The substantially cylindrical interior space of needle retraction tube 42 serves as a retraction cavity. A plurality of ribs (or other similarly effective surface texturing) is desirably provided around section 108 to facilitate gripping of needle retraction tube 42 to rotate needle retraction tube 42 relative to body 34 to initiate needle retraction. needle. The forwardly projecting ear 102 is desirably provided in front of the needle retraction tube 42, and is preferably cooperatively aligned with the positioning notch 64 in the body 34. During assembly, the needle retraction tube 42 is desirably inserted into the opening 86 from the front of the sliding member 38 such that the tube 42 is rotatable about its longitudinal axis when mounted on the sliding member 38 and such that the front face of the annular collar 100 (except for ear 102) is substantially flush with the forward facing surface 84 of slider 38.
    [00032] Referring to figures 1-3, when the IV catheter introducer 80 is fully assembled, and ready for use (with the needle cover removed), the beveled tip of the needle 94 protrudes towards the front of the cannula 44 and the central longitudinal axis of the flash chamber 110 is aligned with the longitudinal axis of the needle. Referring to Figures 5-7 and 8-11, when the needle retraction tube 42 is rotated relative to the body 34, as indicated by arrow 114, the forwardly projecting ear 102 presses against the side of the notch. positioning 64 of body 34 and causes slider 38 to slide relative to body 34 in the direction indicated by arrow 118. As slider 38 moves laterally relative to body 34, fluid seal 68 (Figure 4) disengaging head 74 from needle holder 70, eventually reaching the position shown in Figures 5-7 and 11, wherein the central longitudinal axis through needle retraction tube 42 is aligned with needle holder 70. The diameter of the front opening 98 of the retraction tube 42 (figure 4) is slightly larger than the outer diameter of the head 74 of the needle holder 70, the force of the expansion spring 76 (figure 4) drives the needle holder 70 and the needle 78 backward into the retraction tube d the needle 42.
    [00033] Skilled in the art also realize, upon reading this specification and the description of preferred embodiments disclosed herein, that modifications and changes in the apparatus and method of use can be made within the scope of the invention, and it is intended that the scope of the invention be limited only by the comprehensive interpretation of the appended claims to which inventors are legally entitled.
    权利要求:
    Claims (18)
    [0001]
    1. Needle retraction apparatus, comprising a body (34) with a forwardly projecting needle (78), a needle retraction mechanism (36) seated within the body (34) and biasing the needle (78) backwards. with respect to the body (34), a slider (38) attached to the body (34) and having a second opening (86) communicating with a needle retraction cavity projecting out of the body (34), and an actuator (42 ), wherein the needle retraction mechanism (36) comprises a needle holder (70) seated within the body (34); and wherein the slide element (38) comprises a first opening (90) laterally spaced from the second opening (86), each opening (90, 86) being coaxially alignable with the needle holder (70) at different times by repositioning the slide element (38) in relation to the body (34), characterized in that the actuator (42) is rotatable in relation to the sliding element (38) to reposition the sliding element (38) from a first position that prevents retraction of the needle to a second position that allows retraction of the needle.
    [0002]
    2. Needle retraction apparatus according to claim 1, characterized in that the first opening (90) in the sliding element (38) communicates with a lightning chamber (110).
    [0003]
    3. Needle retraction apparatus according to claim 2, characterized in that the second opening (86) in the sliding element (38) communicates with the needle retraction cavity.
    [0004]
    4. Needle retraction apparatus according to claim 2 or 3, characterized in that the lightning chamber (110) has a closed end and disposed opposite the first opening (90) in the sliding element (38).
    [0005]
    5. Needle retraction apparatus according to claim 4, characterized in that the closed end comprises an elastomeric plug (40).
    [0006]
    A needle retraction apparatus according to claim 5, characterized in that the elastomeric plug (40) is penetrated by a cannula to establish a fluid path through the closed end of the flash chamber (110).
    [0007]
    7. Needle retraction apparatus according to any one of claims 1 to 6, characterized in that the actuator (42) is a needle retraction tube.
    [0008]
    8. Needle retraction apparatus according to claim 7, characterized in that the needle retraction tube comprises a projecting ear (102) which engages a positioning notch (64) in the body (34).
    [0009]
    9. Needle retraction apparatus according to claim 7 or 8, characterized in that the rotation of the needle retraction tube (42) repositions the slide element (38) in relation to the body (34).
    [0010]
    10. Needle retraction device according to any one of claims 1 to 9, characterized in that the body (34) additionally comprises a luer tip (56) projecting forward.
    [0011]
    11. Needle retraction apparatus according to claim 10, characterized in that it is in combination with an IV catheter comprising a hub (32) that is releasably attached to the luer tip (56) and a flexible cannula ( 44) attached to the hub (32) through which the needle (78) protrudes forward from the hub (32).
    [0012]
    12. Needle retraction apparatus according to any one of claims 1 to 11, characterized in that the needle (78) is attached to the needle holder (72) and is biased backwards by a retraction spring (36 ) of the compressed needle that makes contact with the needle holder (72).
    [0013]
    13. Needle retraction apparatus according to any one of claims 1 to 12, characterized in that the sliding element (38) is arranged in a transverse sliding fit with a longitudinal axis through the body (34).
    [0014]
    14. Needle retraction apparatus according to any one of claims 1 to 13, characterized in that the sliding element (38) is retained in intimate arrangement with the body (34) by spaced tracks (60, 62) connected in the body (34).
    [0015]
    15. Needle retraction apparatus according to claim 1, characterized in that the needle retraction cavity is disposed within a needle retraction tube (42) which protrudes out of the body (34) .
    [0016]
    16. Needle retraction apparatus according to claim 15, characterized in that the needle retraction tube (42) has an elongated portion with a closed end that can be received through the second opening.
    [0017]
    17. Needle retraction apparatus according to claim 15 or 16, characterized in that the needle retraction tube (42) has an open end (98) with a radially projecting annular flange (100) having a diameter larger than the second opening (86) and is supported in a forward-facing recess (82) in the sliding member (38).
    [0018]
    18. IV catheter introducer, characterized in that it comprises the needle retraction device as defined in any one of claims 1 to 17.
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    MX363472B|2019-03-25|
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    法律状态:
    2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-12-31| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-06-15| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-07-13| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/11/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/841,462|2013-03-15|
    US13/841,462|US9308353B2|2010-07-29|2013-03-15|Needle retraction apparatus|
    PCT/US2013/072222|WO2014143220A1|2013-03-15|2013-11-27|Needle retraction apparatus|
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