• 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:
    ANGLED RETRACTION SHEATH FOR SAFETY NEEDLE. This is a safety needle device that has a housing, a retractable sheath, and a needle cannula. The retractable sheath includes a tubular portion that is slidably mounted over a portion of the housing to completely or partially enclose the length of the cannula. The retractable sheath includes a sheath bevel at the distal end that has a blunt or angled tip. The angled tip is configured for suitable injection angles and can be fixed or swivelable. The sheath bezel may include a skin contact surface at the distal end. The needle can be connected to a needle connector at the proximal end of the housing and includes a needle bevel at the distal end. The sheath bevel and the needle bevel can be offset from each other. A safety needle device that has a retractable sheath that has a graduated injection depth gauge to indicate needle penetration is also described.
    公开号:BR112014022582B1
    申请号:R112014022582-6
    申请日:2013-03-14
    公开日:2021-07-20
    发明作者:Andrew Wong；Matthew Zachek
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    FIELD OF TECHNIQUE
    [001] The subject of the invention relates generally to a safety needle device, and more particularly to a safety needle device having a housing, a retractable sheath, and a needle cannula. The retractable sheath having a tubular portion that is slidably mounted over a portion of the housing to completely or partially enclose the length of the cannula. The retractable sheath also has a sheath bezel at the distal end. The sheath bezel that has a blunt or angled tip. The angled tip is configured for suitable injection angles and can be fixed or swivelable. The sheath bezel may have a skin contact surface at the distal end. The needle can be connected to a needle hub at the proximal end of the housing and includes a needle bevel at the distal end. The sheath bevel and the needle bevel can be offset from each other. A safety needle device that has a retractable sheath has a graduated injection depth gauge to indicate needle penetration is also described. BACKGROUND
    [002] Needle devices are used throughout the medical industry for the injection and removal of a wide variety of fluids and solutions in the human body. Due to the numerous potential risks associated with handling and handling bodily fluids, and particularly blood, there are a number of known safety features that are often incorporated into various types of needle devices to protect the practitioner from accidental needle exposure.
    [003] Previously retraction sheath safety needle devices were developed including a blunt tip for injection perpendicular to the injection site. While a blunt tip may be ideal for most intramuscular injections, administering other injection techniques, such as intradermally or subcutaneously, may require different injection angles. For example, shallow injection angles are difficult or impossible with existing needle safety devices.
    [004] Previously retraction sheath safety needle devices were developed including a disposable cover assembly that hides a substantial majority or all of the injection needle from view before, during, and after an injection procedure. However, many injection procedures require the provider to know precisely the depth at which the needle is inserted into the patient's tissue to ensure that the medication is administered to an appropriate location. Previously retraction sheath safety needle devices did not have depth gauges so injection depth can be quickly and easily determined.
    [005] There is a need to provide a safety needle device that has a sheath tip configured for several different injection angles to facilitate the administration of injection techniques, such as intradermal and subcutaneous, which may require shallow injection angles.
    [006] There is also a need in the art to provide a safety needle device that has a depth gauge feature that is able to quickly and easily determine the injection depth, this is especially useful for some types of injections, as intramuscular and subcutaneous. SUMMARY
    [007] The present invention relates to a safety needle device that includes a housing that has a proximal end and a distal end that have an opening. The safety needle device also includes a retractable sheath disposed and movable in the opening and surrounding a needle. The needle can be attached to a needle hub at the proximal end of the housing and has a blunt or beveled tip at the distal end. In one or more embodiments, the proximal end of the housing can be connectable to a luer fitting or other fluid connector, or integrated into a device such as a syringe. The retractable sheath may include a sheath bevel at the distal end. The sheath bevel and needle bevel are offset from each other. In one embodiment, the sheath bevel and needle bevel can be offset by 180 degrees.
    [008] In one or more embodiments of the present invention, the sheath bezel includes a section of skin contact surfaces. The skin-contacting surface section holds the skin taut before an injection and may include a friction-enhancing material.
    [009] In one or more embodiments of the present invention, the sheath bezel includes at least one injection angle guide configured in the range between 10 to 90 degrees. In one or more modalities, the injection angle guide can be set in the range between 5 to 50 degrees. In another embodiment, the injection angle guide is configured as a blunt tip.
    [010] In yet another embodiment, the sheath bezel includes at least two injection angle guides wherein a first injection angle guide is set in the range between 10 to 90 degrees and a second injection angle guide is set to be greater than the first angle and is in the range between 10 to 90 degrees. In one or more embodiments, the first injection angle guide is configured as a blunt tip. In one or more embodiments, the second injection angle guide is configured as a blunt tip.
    [011] In one or more embodiments, the injection angle guide can be fixed or swivelable to adjust the needle bevel angle relative to an injection site.
    [012] In one or more embodiments, the sheath bezel may have a frustoconical shaped tip.
    [013] The frustoconical shaped tip may be transparent, and may be comprised of a different material, and/or may include a thin transparent overmold. The tip and/or overmold can be made of a material that has a high coefficient of friction with the skin.
    [014] In one or more embodiments, the sheath bezel may have a curved tip. The curved tip may include a high friction contact surface.
    [015] In one or more embodiments, the sheath bezel may have a blunt tip that includes an axial projection facing the distal direction. The axial projection may further include a protrusion made of a material that has a high coefficient of friction with the skin.
    [016] The present invention also relates to a safety needle device that includes a housing that has a proximal end and a distal end that have an opening. In one or more embodiments, the proximal end of the housing can be connectable to a luer fitting or other fluid connector, or integrated into a device such as a syringe.
    [017] The safety needle device also includes a retractable sheath disposed and movable in the opening and surrounding a needle. The retractable sheath may include a graduated injection depth gauge to indicate needle penetration and a sheath bevel at the distal end. The needle may be connected to a needle hub at the proximal end of the housing and may have a needle bevel at the distal end. The sheath bevel and the needle bevel can be offset from each other.
    [018] In one or more modalities, the graduated injection depth gauge can be printed on an outer surface of the retractable sheath. In another embodiment, the graduated injection depth gauge may be notched, engraved, embossed, embossed by molding, or formed on an outer surface of the retractable sheath.
    [019] In one or more embodiments, the graduated injection depth gauge can be scaled to correlate with needle length or injection angles. The needle penetration depth can be read from the intersection of the scale and the connector.
    [020] The safety needle device may further include a visual indicator for reading the graduated injection depth gauge, which includes an enlarged window, arrow, line or other visible feature or mark printed or formed on the retractable sheath. BRIEF DESCRIPTION OF THE DRAWINGS
    [021] Figure 1 is a perspective view of the safety needle device before injection into the skin.
    [022] Figure 2 is a perspective view of the safety needle device after injection into the skin.
    [023] Figure 3 is a perspective view of the safety needle device that has two bevel guides according to an alternative embodiment of the present invention.
    [024] Figure 4 is a perspective view of the safety needle device that has two bevel guides according to an alternative embodiment of the present invention.
    [025] Figure 5 is a perspective view of the safety needle device that has two bevel guides according to an alternative embodiment of the present invention.
    [026] Figure 6 is a perspective view of the safety needle device that has two bevel guides according to an alternative embodiment of the present invention.
    [027] Figure 7 is a perspective view of the safety needle device that has two bevel guides according to an alternative embodiment of the present invention. DETAILED DESCRIPTION
    [028] Before describing various exemplary embodiments of the invention, it should be understood that the invention is not limited to the construction details or process steps presented in the following description. The invention is capable of other modalities and of being practiced or carried out in various ways.
    [029] In this description, a convention is followed in which the distal end of the device is the end closest to a patient and the proximal end of the device is the end distal to the patient and closest to a practitioner.
    [030] Figure 1 illustrates an exemplary safety needle device 10 according to the present invention. Generally speaking, safety needle device 10 is comprised of a needle 40, a housing 20, and a retractable sheath 50. Housing 20 includes a proximal end 22 and a distal end 24 that have an opening 26. or more embodiments, the proximal end of the housing may be connectable to a luer connection 30 or other fluid connector. The retractable sheath 50 is slidably and movably mounted in the opening 26 to accommodate and slidingly enclose the needle 40 which protrudes axially from the housing 20. The term "retractable sheath" is intended to include any type of tubular element. The retractable sheath 50 is sized to be compatible with the size and type of needle 40 as will be appreciated by those skilled in the art. The housing 20 may include a housing body portion with an inner hollow region (not shown) in which the retractable sheath 50 is movable in the proximal direction. Needle 40 may be connected to a needle hub (not shown) disposed at the proximal end 22 of housing 20 and has a blunt or beveled tip at the distal end. The needle is disposed in the needle hub in a way that could be well understood in the art and that does not form part of the invention. The needle hub may be integrally formed with the housing body portion. Needle 40 extends from needle hub disposed in housing 20 to a needle tip and is fully received within retractable sheath 50 when retractable sheath 50 is in a distal position. The needle tip is exposed from the retractable sheath 50 when the retractable sheath 50 is in a proximal position. Retractable sheath 50 may include a sheath bevel 54 at the distal end. Sheath bevel 54 and needle bevel 48 are offset from each other. In one embodiment, the sheath bevel 54 and needle bevel 48 can be offset by 180 degrees.
    [031] As illustrated in various drawings, most notably in Figure 2, the retractable sheath 50 is generally comprised of a tubular portion and is retractably slidable along the length of needle 40 so that at least a substantial portion of needle 40 is exposed when sheath 50 is in its retracted position. As shown in Figure 1, the length of needle 40 extending outward from the needle hub in a distal direction is partially or fully closed when the retractable sheath 50 is in its unretracted position.
    [032] Upon administration of the injection, the retractable sheath 50 moves from a distal to a proximal position and the needle tip is exposed so that the needle tip can penetrate the injection site. Upon continued application of force by pressing sheath 50 against the skin at the site where needle 40 is to be inserted, sheath 50 retracts into housing 20 allowing the injection site to be penetrated by the needle tip. When the retractable sheath 50 reaches a fully retracted position (in the most proximal position), the needle reaches a fully extended position where the needle tip reaches its maximum penetration of the injection site. Upon completion of an injection, the practitioner need only remove the needle to resiliently return the retractable sheath 50 to the fully extended condition to be repositioned again to enclose the needle 40. In one or more embodiments herein In the invention, the retractable sheath is connected to the proximal end of the housing by a spring mechanism that acts to resiliently return the retractable sheath to the fully extended condition.
    [033] The retraction sheath 50 can include a bevel formed or cut at the tip at optimal angles for specific injection procedures. For example, for intradermal injections the ideal injection angle could be 10-15 degrees, therefore, in one or more embodiments of the present invention, the bevel tip could be 10-15 degrees to guide the user at that angle. In one or more embodiments of the present invention, the sheath bezel 54 includes at least one injection angle guide configured in the range of 10 to 90 degrees. In one or more embodiments, the injection angle guide 58 can be configured in the range of 5 to 50 degrees. In another embodiment, the extreme tip of the injection angle guide is configured as a blunt tip 52 so that perpendicular injections continue to be comfortable for a patient.
    [034] In yet another embodiment, the sheath bezel 54 includes at least two injection angle guides wherein a first injection angle guide is configured in the range between 10 to 90 degrees and a second injection angle guide is configured to be larger than the first angle and is in the range between 10 to 90 degrees. In one or more embodiments, the first injection angle guide can be configured as a blunt tip. In one or more embodiments, the second injection angle guide can be configured as a blunt tip. In one or more embodiments, a third or other injection angle guide can be configured as a blunt tip. A multi-beveled hem stitch can be formed through a plurality of individual bevels which together define a beveled face around the distal end periphery of the retractable sheath. In one embodiment, the multi-beveled stitch is characterized by a primary bevel 62; a secondary bevel 64, and a blunt tip 52. The secondary bevel 64 is formed on opposite sides of the primary bevel 62. The primary bevel 62 and the secondary bevels 64 meet at an “A” intersection shown in Figure 3 which demarcates their respective planes in which the primary bevel and the secondary bevels are formed. This could allow for almost all common injection techniques, with shallow, medium and perpendicular injection angles.
    [035] As shown in Figures 4-7, it is envisioned that the sheath bevel 54 in one or more embodiments is configured to allow continuously variable injection angles. As shown in Figures 4 and 5, the bevel tip can be configured in a frustoconical shape to allow for continuously variable injection angles. As shown in Figure 4, the sheath bezel 54 can also include a transparent rubber tip. The sheath bezel 54 may also include a thin, preferably transparent, overmold as shown in Figure 5. The overmold may be made of any resilient, flexible material having a suitable coefficient of friction with the skin including, but not limited to, rubber. Figure 6 shows the sheath bezel that has a curved contact surface. The curved tip of the sheath bezel may also include an adherent high friction contact surface. The material of construction of the high friction contact surface can be any resilient, flexible material with an adequate coefficient of friction with the skin. Suitable materials include substances such as latex rubber, butyl rubber, silicone and the like. Alternatively, additional materials may be omitted if the contact surfaces have sufficient adhesion. Figure 7 shows the sheath bezel having a blunt tip 60 that includes an axial projection 70 facing in the distal direction. The axial projection of the blunt tip may also include a protrusion 80. The material of construction for the protrusion over the axial projection may be any resilient, flexible material with an adequate coefficient of friction with the skin. Suitable materials for the overhang include substances such as latex rubber, butyl rubber, silicone and the like. In this mode, the tip 70 is the only point of contact, allowing rotation around that point, and therefore a continuously variable injection angle.
    [036] In one or more embodiments, the injection angle guide can be fixed or swivelable to adjust the needle bevel angle relative to an injection site. It is believed that most, if not all, of common injections are "tilted up" or not oriented in relation to the bevel. In a preferred embodiment, the needle bevel 48 is oriented in an upward position relative to the injection angle guide and the injection angle.
    [037] In some types of injection technique, it is desired to firmly pull the patient's skin before administering the injection. In one or more embodiments of the present invention, the sheath bezel 54 includes a skin-contacting surface section 56 to increase friction between the bevel tip and the patient's skin to keep the patient's skin taut prior to an injection. . Upon contact with the patient's skin, the skin contact surface is frictionally or adhesively fixed and exerts an external or lateral force on the injection site so that the skin is kept taut before the needle tip pierces the injection site. At the same time, the needle tip can be extended until the needle tip penetrates the skin at the injection site. The skin contact surface is placed on the bevel tip of the sheath. In a preferred embodiment, the skin-contacting surface section 56 is positioned at a distal end of the sheath bevel. The skin contacting surface section 56 may be comprised of a friction enhancing material. The material of construction for the skin-contacting surface may be any resilient, flexible material with the proper coefficient of friction with the skin. Suitable materials include polymeric substances such as latex rubber, butyl rubber, silicone and the like. In a preferred embodiment, the skin-contacting surface operates in combination with the spring force of the sheath to firmly pull the patient's skin.
    [038] The needle 40 according to the present invention may be formed from conventional materials such as steel or more preferably stainless steel. It will be appreciated by those skilled in the art that plastics, composites, medical grade ceramics, or similar materials can be substituted. Bevels can be formed on needle 40 by conventional processes such as milling.
    [039] The inner diameter of the open-end retraction sheath 50 is selected so that it will fit closely with the needle 40 and still slide freely along the needle 40. The retraction sheath 50 can be made of any suitable material, however preferably from a polymer that is strong enough to protect needle 40 and can be easily sterilized. The material is preferably transparent or translucent so that the position of needle 40 within retraction sheath 50 can be visually verified. Sheath 50 is preferably made of a transparent material so that a healthcare professional can see the progress of needle 40 as it emerges from sheath 50 to ensure that it is positioned in the desired location for an injection.
    [040] In another embodiment, the present invention also relates to a safety needle device 10 that includes a housing 20, which has a proximal end 22 and a distal end 24 that has an opening 26, and a retractable sheath 50 that has a graduated injection depth gauge to indicate needle penetration. In one or more embodiments, the proximal end of the housing may be connectable to a luer connection 30 or other fluid connector. Retractable sheath 50 is disposed and movable in opening 26 and surrounds a needle 40. Retractable sheath 50 includes a sheath bevel 54 at the distal end. Needle 40 may be connected to a needle hub at the proximal end 22 of housing 20 and may have a needle bevel 48 at the distal end. Sheath bevel 54 and needle bevel 48 can be offset from each other.
    [041] As the injection is performed and the needle 40 is inserted into the tissue, the retractable sheath 50 is pushed into the housing 20. As shown in Figure 1 and 2, the depth of the needle 40 can be read from the meter where it enters the connector in the mode shown.
    [042] In one or more embodiments, the graduated injection depth gauge may be printed on an outer surface of the retractable sheath 50. In another embodiment, the graduated injection depth gauge may be carved, engraved, embossed, embossed by molding or formed on an outer surface of the retractable sheath 50 to help the practitioner measure needle depth penetration.
    [043] The depth gauge represented to scale in the mode shown could be unique for each needle length.
    [044] It is anticipated that different injection angles on the same device may require different scales. For example, in a perpendicular injection, the needle 40 could enter a depth relative to the scale other than a shallow angle. Therefore, it is contemplated that multiple scales may be required if accurate readings are taken at different injection angles.
    [045] In one or more embodiments, the graduated injection depth gauge can be scaled to correlate needle length or injection angles. Needle penetration depth can be read from the intersection of penetration depth markers appearing on the outside of retractable sheath 50 and the distal end of housing 24. Depth markers can be arranged so that when needle 40 is in a home position, for example, the retractable sheath 50 is in the most distal position, the position of the needle point in relation to the depth markers indicates, for example, the maximum penetration depth of the needle tip.
    [046] The safety needle device 10 may further include a visual indicator to read the graduated injection depth gauge, including an enlarged readout window, arrow, line, or other visible feature or mark imprinted or formed on the retractable sheath 50. Other visual markers can also be used, for example symbols and words can be arranged in the retraction sheath 50.
    [047] Reference throughout this descriptive report to "a modality", "some modalities", "one or more modalities" or "any modality" means that a particular attribute, structure, material, or characteristic described in conjunction with the modality is included in at least one embodiment of the invention. Thus, the appearance of phrases such as “in one or more modalities”, “in some modalities”, “in a modality” or “in any modality” in several places throughout this descriptive report does not necessarily refer to the same modality of the invention. Furthermore, particular attributes, structures, materials, or characteristics may be combined in any suitable way in one or more modalities.
    [048] Although the invention is described herein with reference to particular embodiments, it will be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It will be apparent to those skilled in the art that various modifications and variations can be made to the method and apparatus of the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention include modifications and variations that are within the scope of the appended claims and their equivalents.
    权利要求:
    Claims (17)
    [0001]
    1. A safety needle device (10), comprising: a housing (20) having a proximal end (22) and a distal end (24) having an opening (26); a retractable sheath (50) disposed and movable in the opening and surrounding a needle (40); the needle (40) connected to a needle hub (80) at the proximal end of the housing and having a needle bevel at the distal end; the retractable sheath (50) having a sheath bevel (54) at the distal end, CHARACTERIZED in that the sheath bevel (54) comprises at least two injection angle guides (58) and includes a section of contact surfaces with the skin comprised of a friction enhancing material to keep the skin taut before an injection, the sheath bevel and needle bevel being offset from each other.
    [0002]
    2. Safety needle device according to claim 1, CHARACTERIZED by the fact that the sheath bevel and the needle bevel are offset by 180 degrees.
    [0003]
    3. Safety needle device according to claim 1, CHARACTERIZED by the fact that the sheath bezel comprises at least one injection angle guide (58) configured in the range between 5 to 90 degrees.
    [0004]
    4. Safety needle device according to claim 3, CHARACTERIZED by the fact that at least one injection angle guide is configured as a blunt tip (60).
    [0005]
    5. Safety needle device according to claim 1, CHARACTERIZED by the fact that a first injection angle guide is configured in the range between 10 to 90 degrees and a second injection angle guide is configured to be greater than than the first injection angle and is in the range between 10 to 90 degrees.
    [0006]
    6. Safety needle device according to claim 5, CHARACTERIZED by the fact that the second injection angle guide is configured as a blunt tip.
    [0007]
    7. Safety needle device according to claim 5, CHARACTERIZED by the fact that it further comprises a third injection angle guide configured as a blunt tip.
    [0008]
    8. Safety needle device according to claim 3, CHARACTERIZED by the fact that at least one injection angle guide is swivelable to adjust the needle bevel angle with respect to an injection site.
    [0009]
    9. Safety needle device, according to claim 1, CHARACTERIZED by the fact that the sheath bezel has a tip in a frustoconical shape.
    [0010]
    10. Safety needle device according to claim 1, CHARACTERIZED by the fact that the sheath bezel has a curved tip that has a high friction contact surface.
    [0011]
    11. Safety needle device according to claim 1, CHARACTERIZED by the fact that the sheath bezel comprising a blunt tip that has an axial projection facing the distal direction.
    [0012]
    12. Safety needle device according to claim 11, CHARACTERIZED by the fact that the axial projection also includes a protrusion made of a material that has a high coefficient of friction with the skin.
    [0013]
    13. Safety needle device according to claim 1, CHARACTERIZED by the fact that it further comprises: a retractable sheath having a graduated injection depth gauge to indicate the depth of penetration of the needle and a sheath bevel at the end distal; where the depth of needle penetration can be read from the intersection of the scale and the cube.
    [0014]
    14. Safety needle device according to claim 13, CHARACTERIZED by the fact that the graduated injection depth gauge is printed, notched, engraved, embossed, or embossed on an outer surface of the retractable sheath.
    [0015]
    15. Safety needle device according to claim 13, CHARACTERIZED by the fact that the graduated injection depth gauge is represented to scale to correlate with the needle length or injection angles.
    [0016]
    16. Safety needle device according to claim 13, CHARACTERIZED by the fact that it additionally comprises a visual indicator to read the graduated injection depth meter.
    [0017]
    17. Safety needle device according to claim 16, CHARACTERIZED by the fact that the indicator is an enlarged window.
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    AU2016203190B2|2017-06-15|
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    CA2867152A1|2013-09-19|
    CA2959785C|2020-07-28|
    JP6240148B2|2017-11-29|
    US8801680B2|2014-08-12|
    WO2013138555A3|2014-04-10|
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    法律状态:
    2018-12-04| 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]|
    2021-06-22| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-07-20| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 14/03/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201261610576P| true| 2012-03-14|2012-03-14|
    US61/610,576|2012-03-14|
    US13/793,831|US8801680B2|2012-03-14|2013-03-11|Angled retracting sheath for safety needle|
    US13/793,831|2013-03-11|
    PCT/US2013/031191|WO2013138555A2|2012-03-14|2013-03-14|Angled retracting sheath for safety needle|
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