• 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:
    CATHETER SET The invention relates to a catheter set (10) comprising: a catheter (12); a catheter cube (14) having a distal section and a proximal section, in which the distal section is joined to the catheter (12) and the proximal section defines a chamber (24); a needle (16) extending through the catheter hub (12) and defining an axial direction in which the needle (16) has opposite proximal and distal ends, the distal end forming a needle tip (18); a needle hub (20) attached to the proximal end of the needle (16); and a needle guard (26) slidably disposed on the needle, where the needle guard (26) is retained in the chamber (24) of the catheter hub (14) when the needle (16) extends through the catheter hub ( 14) and the catheter (12), and where the needle guard (26) is removable from the catheter hub (14) once the needle tip (18) is received in the needle guard (26) right after removal of the needle (16) from the catheter (12).
    公开号:BR112013006785B1
    申请号:R112013006785-3
    申请日:2011-09-21
    公开日:2020-12-08
    发明作者:Rishi Baid
    申请人:Poly Medicure Limited；
    IPC主号:
    专利说明:

    description RELATED ORDER CROSS REFERENCE
    This application claims the priority of Indian Patent Application No. 2253 / DEL / 2010, filed on September 21, 2010, the full disclosure of which is incorporated into this document by reference. FIELD OF THE INVENTION
    The present invention relates, in general, to the intravenous catheter assembly. More particularly, the present invention relates to a catheter assembly with improved safety means which automatically covers the fine tip of the needle after withdrawing the needle from the catheter and the catheter hub. BACKGROUND OF THE INVENTION
    A catheter assembly of the above type is generally known and typically used to facilitate the insertion and placement of a catheter or other medical device in a patient's vasculature.
    Due to the increasing incidence of blood-borne pathogens, such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), there is a constant need to protect doctors and health workers or personnel who handles catheter assemblies from accidental contact with the fine needle tip after removing the needle from the catheter and the catheter hub. SUMMARY OF THE INVENTION
    The invention in its most comprehensive aspect incorporates an intravenous catheter assembly comprising a catheter, a catheter hub having a distal section and a proximal section, in which the distal section is joined to the catheter and the proximal section defines a chamber, a needle extending through the catheter hub and the catheter and defining an axial direction, in which the needle has opposite proximal and distal ends, the distal end forming a tip, in which the distal end of said needle has a different dimension (protuberance or crimp) proximal at said needle tip, a needle hub attached to the proximal end of the needle; and a needle protector slidably arranged on the needle to protect said needle tip having a base portion with a hole extending in an axial direction through the hole to receive a needle; and two opposing grips extending from the base portion generally in the axial direction, and each having a head portion in the region of its free end characterized by the fact that said needle protector is partially or completely fixed in the hub chamber catheter or completely outside the catheter hub by means configured in and / or outside said needle protector and by means configured in and / or outside said catheter hub when the needle extends through said catheter hub and catheter, wherein said needle protector is removable from the catheter hub once the tear or crimp proximal to said needle tip is received in the needle protector right after the needle is removed from said catheter, and in which said needle protector comprises a resilient member or elastic element or tension ring surrounding the two opposite claws integrated thereto in a region between the base portion and the head portions of said needle protector.
    The needle as described has a protuberance or crimp proximal to the tip of the needle. This protuberance or bezel is used as an obstruction when the needle guard is in a protective position, that is, covering the needle tip. As the needle protector slides along the needle the protuberance or crimp proximal to the needle tip engages the needle protector base and locks the needle protector on the tip, thereby preventing slipping.
    The means configured on the inner surface of the needle guard may comprise at least one engagement, and / or retaining, and / or recess projection, and / or a combination of a projection and a recess capable of partially securing the needle guard and / or completely in the catheter hub chamber.
    The means configured on the outer surface of the needle guard may comprise retaining and / or latching arms attached to the base portion of the needle guard retaining and / or partially and / or fully engaging the catheter hub chamber when the needle extends through the catheter hub and the catheter, and where the needle protector is driven to protect the needle tip once the protuberance, hole, tear and / or depression proximal to said needle tip is received in the needle protector right after removing the needle from the catheter.
    The means configured on the inner surface of the catheter hub may comprise at least one annular projection, and / or recess and / or a combination of a projection and a recess configured within said catheter hub to partially secure the needle guard and / or completely in the catheter hub chamber.
    The means configured on the external surface of the catheter hub may comprise at least one engagement projection, and / or retention, and / or recess, and / or a combination of a projection and a recess for engaging and / or retaining the protector. needle partially and / or completely into the catheter hub chamber.
    It is, therefore, a main object of this invention to provide a catheter assembly that can be manufactured at low cost, that is easy to operate and design, and that provides reliable protection against accidental needle stick, once the needle has been removal of the catheter and catheter hub. BRIEF DESCRIPTION OF THE DRAWINGS
    Figs. IA and B show side views of a catheter assembly of the invention before use.
    Fig. 2 shows a perspective view of a needle, a needle hub attached to it and a needle protector protecting a tip of the needle after using the catheter assembly of fig. 1.
    Figs. 3A to C show perspective views (A and B) and a side view (C) of the needle guard of fig. two.
    Fig. 4 shows a longitudinal sectional view of a needle guard received in a catheter hub from the catheter assembly of fig. 1.
    Figs. 5A and B show a side view (A) and a perspective view (C) of an alternative needle guard.
    Figs. 6A to C show a side view (A), a perspective view (B) and a longitudinal sectional view (C) of the needle guard of fig. 5 without the tension element.
    Fig. 7 shows a longitudinal sectional view of a needle protector partially received in a catheter hub of the catheter assembly of fig. 1.
    Fig. 8 shows a longitudinal sectional view of a needle guard completely out of the catheter hub of the catheter assembly of FIG. 1. DETAILED DESCRIPTION OF THE INVENTION AND DRAWINGS
    A reading of all the figures together describes the invention incorporating an intravenous catheter set 10 comprising a catheter 12, a catheter hub 14 having a distal section and a proximal section, wherein the distal section is joined to catheter 12 and the proximal section defines a chamber 24, a needle 16 extending through the catheter hub 14 and the catheter 12 and defining an axial direction, where the needle 16 has opposite proximal and distal ends, the distal end forming a tip 18, where the distal end said tip has a different dimension (crimp or protuberance) proximal to said needle tip 18, a needle hub 20 attached to the proximal end of needle 16; and a needle guard 26 slidably arranged on the needle 16 to cover said needle tip 18 having a base portion 28 with a hole 52 extending in an axial direction through the hole 52 to receive a needle 16; and two opposite claws (30, 32) extending from the base portion 28 generally in the axial direction, and each having a head portion in the region of its free end, wherein said needle guard 26 is partially or completely attached in the chamber of the catheter hub 14 or completely outside the catheter hub by means 52 configured inside and / or outside said needle guard 26 and by means 80 configured inside and / or outside said catheter hub 14 when the needle 16 extends through said catheter hub 14 and catheter 12, wherein said needle guard 26 is removable from catheter hub 14 since the crimp or protuberance proximal to said needle tip 18 is received on needle guard 26 shortly after withdrawing the needle 16 from said catheter 12 and wherein said needle protector 26 comprises a resilient member 48, or elastic element 48, or tension ring 48 surrounding the two opposite claws (30, 32) integrated therein in a region between the base portion and the head portions of said needle protector.
    Fig. 1 shows a catheter assembly 10 according to the invention before use. The catheter assembly 10 includes a tube-type catheter 12 having distal and proximal ends, and a catheter hub 14 attached to catheter 12 at the proximal end of catheter 12.
    The catheter assembly 10 further comprises a needle 16 extending through the catheter 12 and the catheter hub 14 and defining an axial direction. Needle 16 has distal and proximal ends, where a fine needle tip 18 is formed at the distal end of needle 16, which protrudes from catheter 12 at the distal end thereof.
    A needle hub 20 is — attached- to needle 16 at the proximal end of needle 16. A port member 22 is mounted on needle hub 20 on a proximal side of needle hub 20, which makes it possible to connect, for example, a PVC tube to the catheter assembly 10 to collect blood from a patient or deliver a fluid to be administered to a patient.
    The catheter hub 14 defines an inner chamber 24 (fig. 4 & 7) in which a needle guard 26 is fully or partially seated. In fig. 1 only a retaining arm 54 of the needle guard 26 can be seen. The needle guard 26 is slidably arranged on the needle 16 such that it moves along the needle 16 when the needle 16 is removed from the catheter 12. The purpose of the needle guard 26 is to cover the needle tip 18 after needle 16 has been used in order to prevent accidental pricking by needle 16 to a person handling the catheter assembly 10, as can be seen from fig. two.
    As shown in fig. 3, needle guard 26 includes a generally cylindrical base portion 28 at a proximal end of needle guard 26. The first and second arms 30, 32 extend from a distal face 34 of the base portion 28 generally in the axial direction. The first arm 30 is longer than the second arm 32.
    A transverse wall 36 is arranged in a distal region of the first arm 30. The dimension of the transverse wall 36 as seen in a radial direction is selected in such a way that the transverse wall 36 overlaps the second arm 32 when a needle tip 18 is received in the needle guard 26, that is, between the first and second arms 30, 32, such that the needle tip 18 is prevented by the transverse wall 36 from protruding distally from the needle guard 26 (fig. two).
    Before use, that is, when needle -16 extends all the way through needle guard 26, the cross wall 36 is supported on needle 16 and the first arm 30 is deflected against the second arm 32. An axial groove 38 is provided in the cross wall 36 on its side 40 facing the needle 16, in order to guide the cross wall 36 over the needle 16, in particular, when the needle 16 is pulled through the needle guard 26 just after the needle withdrawal 16 from catheter 12.
    A recess 42 is provided on the outer surface of a proximal section 44 of the first arm 30, in order to increase the deflexibility of the first arm 30.
    The distal sections 46, 47 of the first and second arms 30, 32 have outer surfaces that are tapered to the distal ends of the first and second arms 30, 32. The first and second arms 30, 32 are surrounded by an elastic band 48 in the region distal sections 46, 47. Due to the tapered outer surfaces of distal sections 46, 47 the elastic band 48 is prevented from sliding away from distal sections 46, 47 towards the proximal end of needle guard 26 when the first and second arms 30, 32 are pushed away against a restoring force of the elastic band 48 by the needle 16 extending all the way through the needle protector 26. In order to further define the axial position of the elastic band 48, projections 50 extending along the contour outer of the first and second arms 30, 32 can be supplied adjacent to the elastic band 48 (fig. 4). These projections 50 are not shown in Figs. 2 and 3.
    As best seen in fig. 4 and 7, an axial hole 52 extends through the base portion 28 of the needle guard 26 to receive the needle 16. The profile of the hole 52 is adapted to the principle of external profile of the needle 16. The needle 16 has a change in the profile , in particular, an enlargement (not shown), close to its needle tip 18, - which has an external profile, one dimension of which is greater than the maximum dimension of the profile of hole 52. Thus, the change in the profile prevents the needle guard 26 from sliding off needle 16 when a needle tip 18 is received between the first and second arms 30, 32 and is covered by the needle guard 26.
    In another construction, an axial hole 52 extends through the base portion 28 of the needle guard 26 to receive the needle 16. The profile of the hole 52 is adapted to the principle of the outer profile of the needle 16. The needle 16 has a change in profile, in particular, a bezel (not shown), close to its needle tip 18, which has an external profile, one dimension of which is less than a maximum dimension of the profile of hole 52. Thus, the change in the profile prevents the needle guard 26 from sliding off needle 16 when a needle tip 18 is received between the first and second arms 30, 32 and is covered by the needle guard 26.
    A retaining arm 54 is provided on the needle guard 26 in order to secure the needle guard 26 to the chamber 24 of the catheter hub and, in particular, to prevent removal of the needle guard 26 from the catheter hub 14 shortly after removal of the catheter hub. needle 16 before needle tip 18 was securely received in needle guard 26. Retaining arm 54 is connected to base portion 28 of needle guard 26 via a cross section 56. The cross section 56 extends outwardly from the base portion 28 in a generally radial direction on the side of the second arm 32. The retaining arm 54 extends distally from the transverse segment 56 and is slightly inclined towards the second arm 32. Preferably, the retention 45 forms an angle in the range between 0 o and 10 ° with the axial direction, such that an offset between the retention arm 54 and the second arm 32 narrows to a distal end of the retention arm 54.
    A hook-like projection 58 is provided in the region of the distal end of the retaining arm 54. The hook-shaped projection 58 of the retaining arm 54 engages behind a corresponding projection 60 and in a groove or recess 61 provided on the outer surface 62 of the catheter hub 14. Due to the engagement between the hook-like projection 58 of the retaining arm 54 and the combination of the projection 60 and the recess 61 formed in the catheter hub 14, the needle guard 26 is prevented from axial movement relatively to the catheter hub 14 and remains retained in the catheter hub 14 until a traction force exerted by the needle 16 on the base portion 28 of the needle guard 26 by changing the profile of the needle 16 shortly after withdrawing the needle 16 of catheter 12 becomes large enough to disengage the retaining arm 54 from the protrusion 60 of the catheter hub 14.
    It is important to note that instead of a combination of the projection 60 and the recess 61 formed in the catheter hub 14, it is also possible to provide either a projection 60 or a recess 61 on the outer surface 62 of the catheter hub 14 for engagement with the projection of the catheter hub. hook type 58 of the retaining arm 54.
    The retention of the needle guard 26 in the catheter hub 14 can be further improved if the elastic band 48 engages an internal surface 64 of the catheter hub 14 in the away state of the first and second arms 30, 32. Since the needle tip 18 extends across the transverse wall 36 and the first and second arms 30, 32 engage, thereby allowing the elastic band 48 to contract, the elastic band 48 can disengage from the inner surface 64 of the catheter hub 14.
    A support arm 66 is provided on one side of the needle guard 26 opposite the retaining arm 54. The support arm 66 forms a generally right angle with a transverse segment 68 extending from the base portion 28 in a generally radial direction. The support arm 66 is configured to be in contact with the outer surface 62 of the catheter hub 14 over substantially its entire length and width. The support arm 66 thus prevents the needle guard 26 received in the catheter hub 14 from moving in a radial direction inside the chamber 24. The support arm 66 can also help to secure the needle guard 26 against axial movement with respect to the catheter hub 14, thereby increasing the retention of the needle guard 26 in the catheter hub 14. However, the support arm 66 need not necessarily be in such a retention relationship with the catheter hub 14.
    In the embodiment of figures 4 & 7, the retaining arm 54 is provided on the side of the base portion 28 adjacent to the second arm 32, and the support arm 66 is provided on the side of the base portion 28 adjacent to the first arm 30. However, in general it is also possible to provide the retaining arm 54 on the side of the base portion 28 adjacent to the first arm 30 and the support arm 66 on the side of the base portion 28 adjacent to the second arm 32.
    In the embodiments of figure 4, the needle guard 26 is completely inside the catheter hub 14 and is retained on the outside by means of engagement 80 on the catheter hub 14. The engagement means 80 can be in the form of a groove, as shown in figure 4 just below the hook 58 or in the firmness of a protrusion 80, as shown in figures 7 and 8.
    As shown in figs. 1 to 4, 7 and 8, the base portion 28, the first and second arms 30, 32, the retaining arm 54 and the support arm 66 are integrally formed, for example, from a plastic material, by means of molding by injection. However, it is important to understand that this integral design is not mandatory. Conversely, one or more of the named components could be made of a material different from the material of the other components, and this component could be attached to the other components, for example, by gluing, welding, weak brazing or the like.
    Although not shown in figs. 1 to 4, 7 and 8, a limiting element may be provided on the base portion 28 or on the distal face 34 of the base portion 28, wherein the limiting element has a through hole which is aligned with the axial hole 52 in the portion base 28 and which has a profile that is adapted to the principle of external profile of needle 16. Preferably, this type of limiting element would be made of a material of greater hardness and / or rigidity than the material of the base portion 28, of such that this limiting element withstands greater forces exerted by the change in the profile of the needle 16 just after the withdrawal of the needle 16 from the catheter 12, thereby more effectively preventing the change in the profile of the needle 16 from passing through the base portion 28 and, thus preventing needle guard 26 from sliding off needle 16 more effectively.
    Figs. 5 and 6 show an alternative needle guard 26 that can be used in the catheter assembly 10 of the invention. This needle guard 26 generally has the same function, but differs from the needle guard 26 mentioned above basically in that it has no support arm and in that the first arm 30 is not integrally formed with the base portion 28 , with the second arm 32 and the retaining arm 54.
    In contrast, the first arm 30 is made of a strip of laminated metal 70, a distal end portion 72 from which it is curved to form the transverse wall 36 and a proximal end portion 74 from which it is attached, for example, glued or welded to a proximal face 76 of the base portion 28. As described above, the distal sections 46, 47 of the first and second arms 30, 32 are surrounded by an elastic band 48, such that the first and second arms 30 , 32 can be pushed away against a restoring force of elastic band 48 (Fig. 5).
    As best seen in fig. 6C, a through hole 78 is provided in the proximal end portion 74 of the laminated metal strip 70 and is aligned with the axial hole 52 in the base portion 28. The through hole profile 78 is adapted to the main outer profile of the needle 16, while the profile of the axial bore 52 is somewhat wider. Hence, in this needle protector 26, changing the profile of the needle 16, for example, its widening, can slide along the axial hole 52 and is limited in movement in the proximal direction only shortly after engagement with the proximal end portion 74 of the laminated metal strip 70 on the proximal side of the base portion 28. The proximal end portion 74 of the laminated metal strip 70 thus functions as a limiting element of the type already discussed above, and helps to prevent the needle guard 26 to slide off the needle 16.
    In further contrast to the needle guard 26 shown in figs. 1 to 4, 7 and 8, in the needle protector 26 of figs. 5 and 6, the axial groove 38 for guiding the needle 16 just after movement in relation to the needle guard 26 is not provided on the first arm 30, but on the second arm 32, as best seen in fig. 6B.
    Figs. 4, 7 and 8 are embodiments of the invention described above, and work in substantially the same way, and for the sake of brevity -, - repetition is being avoided.
    As can be seen from the description above, the base portion 28 and a first arm 30 of said needle guard are integrally made of a different material, for example, of a plastic material, and the second arm 32 is made of a second different material, such as steel, from said first material. It is well within the scope of this invention that the base portion 28, the first arm 30, the second arm 32 and the holding arm 54 can be made of the same material. Likewise, it is well within the scope of the invention to have all the elements of the needle protector as described, to be single or in separate parts and / or different materials. Reference number list 10 catheter set 12 catheter 14 catheter hub 16 needle 18 needle tip 20 needle hub 22 port member 24 chamber 26 needle guard 28 base portion 30 first arm 32 second arm 34 distal face 36 wall transverse 38 axial groove 40 side 42 recess 44 proximal portion 46 distal section 47 distal section 48 protrusion 52 protrusion 52 axial bore 54 retaining arm 56 segment transverse 58 projection 60 protrusion 61 recess 62 outer surface 64 inner surface 66 support arm 68 segment transverse 70 strip of laminated metal 72 distal end portion 74 proximal end portion 76 proximal face 78 through hole 80 protrusion or groove on the outside of the catheter hub
    权利要求:
    Claims (8)
    [0001]
    1. CATHETER SET (10), comprising: a catheter (12); a catheter cube (14) having a distal section and a proximal section, in which the distal section is joined to the catheter (12) and the proximal section defines a chamber; a needle (16) extending through the catheter hub (14) and catheter (12) and defining an axial direction, in which the needle (16) has opposite proximal and distal ends, the distal end forming a needle tip (18); a needle hub (20) attached to the proximal end of the needle (16); and a needle guard (26) comprising a cylindrical base portion (28) in the region of its proximal end and first and second arms (30, 32) extending in an axial direction from a distal side of the base portion (28), the needle guard (26) is slidably arranged on the needle (16), where the needle guard (26) is partially retained in the catheter hub chamber (14) or the needle guard (26) is completely outside the catheter hub (14) via a retaining arm (54) engaging the outside of the catheter hub (14) when the needle (16) extends through the catheter hub (14) and the catheter ( 12), and where the needle guard (26) is removable from the catheter hub (14) once the needle tip (18) is received in the needle guard (26) right after the needle is removed (16) the catheter (12); a support arm (66) is provided on at least one side of the needle guard (26) opposite the retaining arm (54), where the support arm is configured to be in contact with the outer surface (62) of the catheter hub (14), characterized in that the needle guard (26) is retained outside the catheter hub (14) or partially retained in the catheter hub chamber (14) by engaging (80) in the catheter hub (14) in the form of a protrusion.
    [0002]
    2. CATHETER ASSEMBLY (10) according to claim 1, characterized in that a proximal end of the retaining arm (54) is connected to a base portion of the needle guard (26) via a transverse segment (56 ), in particular, in which the transverse segment (56) extends in a radial direction and / or from a region of the proximal end of the needle guard (26).
    [0003]
    3. CATHETER ASSEMBLY (10), according to claim 1 or 2, characterized in that the retaining arm (54) is inclined and forms an angle between 0 ° and 10 ° with respect to the axial direction, in particular, in such a way that an offset between the retaining arm (54) and the catheter hub (14) narrows to a distal end of the retaining arm (54).
    [0004]
    CATHETER ASSEMBLY (10) according to any one of claims 1 to 3, characterized in that a hook-like projection (58) is provided in the region of a distal end of the retaining arm (54).
    [0005]
    CATHETER ASSEMBLY (10), according to any one of claims 1 to 4, characterized in that the first and second arms (30, 32) are surrounded by a tension element, for example, an elastic band (48), in a distal region of the first and second arms.
    [0006]
    6. CATHETER ASSEMBLY (10), according to claim 5, characterized in that the first and second arms (30, 32) are spaced apart by the needle (16) extending completely through the needle guard (26), in such a way that the tensioning element (48) is placed in a retaining engagement with an internal surface (64) of the catheter hub (14).
    [0007]
    CATHETER ASSEMBLY (10) according to claim 6, characterized in that a transverse wall (36) is arranged in a distal region of one of the first and second arms (30, 32), in which a groove (38) is provided on one side (40) of the transverse wall (36), the groove (38) extending in the axial direction.
    [0008]
    CATHETER ASSEMBLY (10) according to any one of claims 1 to 7, characterized in that the base portion (28) of the needle guard (26) has an axial hole (52) extending through it to receive the needle (16), in which the hole profile (52) is adapted to the main external profile of the needle (16), and the needle (16) has a profile change close to the needle tip (18), said change of profile having an external profile, one dimension of which is greater than a maximum dimension of the hole profile (52).
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    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-09-03| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-05-19| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2020-09-24| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2020-12-08| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/09/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    IN2253/DEL/2010|2010-09-21|
    IN2253DE2010|2010-09-21|
    PCT/IB2011/054137|WO2012038900A1|2010-09-21|2011-09-21|Catheter assembly with improved safety means|
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