巴西专利BR102013033772B1 medical device

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"MEDICAL DEVICE" Medical device having a front accessory and a connector housing at least one body part of an associated medical device, the front accessory slidingly into the connector housing and having a needle protruding forward, rearward and a unit needle retraction chamber, and the connector housing having a needle retraction chamber laterally displaced from the needle in a first position, the needle retraction chamber being selectively movable in relation to the front attachment, after use to reposition the retraction chamber needle, in alignment with the needle, to allow retraction.
公开号:BR102013033772B1
申请号:R102013033772-2
申请日:2013-12-27
公开日:2021-01-26
发明作者:Thomas J. Shaw；Mark Small；Ni Zhu
申请人:Retractable Technologies, Inc.；Thomas J. Shaw；
IPC主号:

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REFERENCE TO RELATED REQUESTS
[001] This application claims the benefit of the previous filing dates of U.S. Provisional Patent Applications Nos. 61 / 737,263, filed on December 4, 2012 and 61 / 836,723, filed on June 19, 2013. This application is also a partial continuation of provisional US Patent Application No. 13 / 714,819, filed on December 14, 2012 , whose priority is claimed. BACKGROUND OF THE INVENTION 1. Field of the Invention
[002] This invention is a medical device having a front attachment comprising a retractable needle. One aspect of the invention relates to a front attachment which desirably attaches to and sits in a sliding fit with a connector housing comprising a unitly shaped or otherwise formed needle retraction chamber and at least one body or tube part of an apparatus associated physician in a laterally distant relationship. The associated medical device may include, for example, a syringe, IV catheter insertion device, infusion set, fluid collection device, or other medical device with which a retractable needle can be used.
[003] Another aspect of the invention relates to a front attachment having a retractable needle propped back and a needle retraction mechanism, in which the needle is longitudinally aligned with a fluid flow path through the connector housing to the associated apparatus , whenever the fluid is flowing through the needle, but it is not aligned with the needle retraction chamber until the needle retraction is initiated.
[004] Another aspect of the invention relates to a connector housing desirably comprising a needle retraction chamber open at one end and having a needle retraction chamber with a longitudinal geometry axis that is substantially parallel to but laterally offset from the geometry axis longitudinal or center line of the needle during use and before retracting the needle.
[005] Another aspect of the invention relates to a connector housing, which is desirably fitted with and slid in relation to a central accessory, in a direction substantially transversal to the longitudinal geometric axis, through a retractable needle placed on the front accessory. The sliding movement is desirably initiated by applying opposing forces to at least the front accessory and the connector housing. One of the opposing forces may be a resistance force.
[006] Another aspect of the invention relates to a medical device, within which a retractable needle holder and needle placed on a front attachment before use are propelled to a safe position after use, so that the tip of the needle is not exposed and the front accessory device cannot be reused. When the needle and needle holder are in the "secure position", the needle holder and part of the needle are desirably arranged in a retraction chamber within a needle retraction chamber that is not coaxially aligned with the needle when the fluid is passing through the needle while using the medical device. 2. Description of the Related Art
[007] Conventional syringes, comprising a generally cylindrical tube, a needle projecting forward from the tube, and a plunger slidably disposed within the tube through an opening at the rear of the tube, are well known. Some conventional syringes are made with a luer slide or luer lock connector on the front of the tube where a cooperatively configured needle or exchangeable needle hole is fixable to allow needles of different calibers or sizes to be used. The luer tips of such syringes are typically exposed to bacterial or viral contamination by accidental contact with a person or object during use. A notable exception is U.S. 8,343,094, which describes a syringe that can be used with an exchangeable needle and also has a protective structure that extends forward beyond the luer tip to reduce the likelihood of contact contamination.
[008] More recently, syringes and other medical devices having fixed or exchangeable needles have been designed to embody various elements of “safety” in an effort to control the spread of blood-borne pathogens and contamination by contact with exposed needles, body fluids or others contaminated objects or surfaces. Such devices sometimes include retractable needles, as in US 7,351,224, but the term “security” is also often applied to products having movable guards, shields or covers, which must be manually manipulated to cover or block access to the tip of a needle that is not retractable after use. The use of such movable guards, shields or covers is not effective, unless the needle is first removed from the patient or other device into which fluid has been injected or extracted. The use of products having movable guards, shields or covers as “safety” elements has, in some cases, been reported to increase the number of accidental needle sticks and such devices should be distinguished from those having retractable needles, and especially those having needles that they can be retracted while still inserted into a patient or other device. Examples of devices incorporating a "safety" element that is not a retractable needle are described in U.S. 5,370,628 and U.S. 8,500,690. US 8,500,690 recognizes that the safety shield described there cannot fully cover the needle cannula until it is completely removed from the patient and also recognizes that automatic shielding can be triggered by the user's intentional or unintended release of the fingertips at any time following the removal of the packaging cover.
[009] In previously known medical devices, having retractable needles and needle retraction mechanisms, a needle retraction chamber is typically provided that is aligned with the longitudinal geometric axis through the needle during use. In such devices, a tube and / or a cylindrical inner part of a plunger cable often serves as the needle retraction chamber. An example of such a device is described in U.S. 7,351,224.
[0010] In other medical devices, the needle retraction chamber is made as a unitary part of a body comprising both a tube and a needle retraction chamber, each having a longitudinal geometric axis that is substantially parallel to and away from the axis longitudinal geometric shape of the other during use. In those devices, however, the needle and needle retraction chamber remain aligned during both use and needle retraction, and a transverse fluid path is provided between the tube and the rear end of the needle. An example of such a device, in which the needle is not extended backwards, is described in U.S. 4,941,883. An example of such a device, in which the needle is propelled backwards, is described in U.S. 6,468,250.
[0011] Among medical devices having retractable needles, some have an actuator to which a retraction force is manually applied to retract the needle by sliding it back into a needle retraction chamber following use. Other devices also automatically retract the needle into a needle retraction chamber after use, or require separate and subsequently applied manual force to initiate needle retraction. The manual force required to initiate needle retraction is sometimes applied longitudinally, such as through all or part of a plunger to replace a retaining plug or member or to cut, fracture or puncture an interfering element. Such devices are described, for example, in U.S. 5,503,010 and Pub. U.S. No. 2008/0287881. Sometimes the initial manual force is applied by articulating a firing element in an angular relationship with the longitudinal geometric axis of the needle to replace an element interfering with the retraction of an element propelled backwards as shown, for example, in the Pub. US No. 2010/0317999. Sometimes the initiating force is applied by lateral movement of an actuator disposed within a housing comprising a needle retraction mechanism as described, for example, in Pub. U.S. No. 2009/0306601. Sometimes the starting force is applied by compressing a lever in a direction transverse to the longitudinal geometric axis through the needle to pull a trigger pin and thereby release a sliding piston unit, propelled backwards by a spring as described, for example, in US 4,973,316. Some known medical devices, as described, for example, in U.S. 7,351,224, have needle retraction mechanisms with needles extended backwards, which allow the needle to be retracted directly from the patient, but many others do not.
[0012] Another known medical device, described in European Order No. EP 0 479 303 A1, is a front fitting for a luer-tip syringe in which the front fitting comprises a needle retraction chamber having a longitudinal geometric axis that is parallel a and away from the longitudinal geometric axis of a connector part to which a luer tip of the syringe is connected. With this device, however, the needle is coaxially aligned with the retraction chamber at all times and a fluid path is provided for the fluid to pass between the syringe and the needle. Also, even though the syringe that can be used is characterized as “conventional” in the description, the plunger part of the syringe is specially adapted by adding a push rod extending forward from the plunger seal that cooperates with the front accessory. The retraction of the needle in the device is initiated manually with an aid provided by a tensioned rubber strip, connected to the distal end of the retraction chamber.
[0013] Although the safety benefits of medical devices having retractable needles have become more widely recognized and appreciated in recent years, in the interest of the safety of patients, their families and health care workers, the need for medical devices remains an economical and reliable front attachment for use with medical devices, such as a conventional syringe or IV catheter introducer having a luer locking connector or luer slide. The necessary devices must be usable without requiring special adaptation or modification of an associated medical device (such as a syringe), have some parts, be comparatively inexpensive to manufacture and incorporate a selectively fixable retractable needle of a desired size and a mechanism retraction needle that can be activated with one hand and retracts the needle directly from a patient without applying force during needle retraction. SUMMARY OF THE INVENTION
[0014] The invention described here is a medical device comprising a front accessory and a connector housing. The front accessory and the connector housing of the subject are desirably selectable and are kept in close relation, sliding between them by one or more structural elements connected to one or both of them. In an embodiment of the invention, the front attachment desirably grips and slips into the connector housing, and a stop member is provided to prevent excess displacement or disengagement. The connector housing also desirably comprises, as an integral part of the device, at least part of a medical device associated with which a retractable needle can be used. Such an associated medical device may include, for example, a syringe, IV catheter insertion device, infusion set, or fluid collection device. The connector housing desirably further comprises a needle retraction chamber and a needle retraction chamber, both having a common longitudinal geometric axis, which is displaced from and not aligned with the longitudinal geometric axis of the needle during use of the medical device and before needle retraction.
[0015] In an embodiment of the invention, the front accessory comprises a body, a needle retraction unit placed inside the body and a needle projecting forward. The needle retraction unit desirably includes a needle holder and a biasing member that extends the needle holder back in relation to the body. The needle protruding forward is desirably supported by the needle holder placed within the body of the subject's front attachment, and the needle holder is extended backwards. A satisfactory bias member is a compressed spiral spring, which is retained in compression when the body is attached to the connector housing, although other similarly effective bias devices may also be used.
[0016] The connector housing desirably further comprises a needle retraction chamber that has at least one open end facing forward, unobstructed, communicating with a needle retraction chamber extending backwards. If desired, small ventilation can also be provided at or near the rear end of the needle retraction chamber. The connector housing is desirably unitary shaped with at least a part of the associated medical device, although other substantially rigid fastening means, such as adhesives, plastic welding or the like can also be used to join a part of an associated medical device, such as a syringe tube, in a substantially fixed positional relationship with the needle retraction chamber of the connector housing. Whether the connector housing is unitarily molded together with, that is, otherwise attached to and made an integral part of at least a part of the associated medical device, the connector housing desirably establishes a substantially linear fluid flow path between the associated device and the needle holder (no need for transverse channels or the like), thereby reducing the pressure required to move fluids from one to another, compared to a non-linear flow path, as could be experienced in a device having a transverse channel between a fluid chamber and the retractable needle.
[0017] A fluid seal is desirably disposed between the front fitting and the connector part of the connector housing, and is placed in a recess arranged in axial alignment with the connector part of the connector housing in coaxial alignment with the needle prior to retraction. In an embodiment of the invention, the fluid seal is annular and movable, so that it remains aligned with the connector part of the connector housing and is repositioned in face contact with the rear part of the front accessory body when the retraction of the front needle is started. The annular fluid seal desirably surrounds the fluid flow path between the connector housing, the front accessory body before retracting the needle and restricts fluid leakage between the facing surfaces of the body and connector housing before, during and after the needle retraction. The needle retraction chamber within the needle retraction chamber of the connector housing is initially displaced from the longitudinal axis through the needle, but is desirably moved laterally into substantial alignment with the needle axis during retraction of the needle. A locking needle cap is desirably provided to prevent premature activation of the needle retraction mechanism during packaging, shipping and handling and to protect the needle tip from becoming blunt, bent or otherwise damaged prior to use.
[0018] Needle retraction is desirably initiated by firming or stabilizing the subject's medical device in relation to the patient and then applying pressure, desirably with one hand, to move the needle retraction chamber and the housing connector in relation to the front accessory, until the retraction chamber is substantially aligned coaxially with the longitudinal geometric axis of the needle. As shown in one embodiment, an optional textured contact surface is arranged on at least one of the front attachment and the connector housing, respectively, to facilitate the application of opposing or opposing forces. Manual pressure is desirably applied in the face directions along a geometry axis, which is substantially parallel to a sliding interface between the front attachment and the connector housing, and substantially transversal to the longitudinal geometry axes laterally spaced through the needle and the camera. needle retraction. As used herein, the term “sliding interface” refers to an interface that allows relative sliding movement between facing surfaces of the front accessory and the connector housing. It should be noted, however, that one of the opposing directed forces, applied to initiate the retraction of the needle in the subject's medical device, may be a resisting force. Although not shown in the attached drawings, we also observed, when reading this description, that a similarly effective but more complex device can replace the manual pressure used to initiate the retraction of the needle. For example, another means of propensity, such as a spring-activated or similarly effective mechanism, may be incorporated into the subject's medical device to reposition the needle retraction chamber in substantial coaxial alignment with the needle to facilitate retraction of the needle. needle after using the device. As will be evident to those skilled in the art, when reading this description, the use of such a propensity means will also require a release or firing element to release the propensity and, thus, initiate the relative sliding movement between the front attachment and the connector housing.
[0019] When the opening into the retraction chamber is sufficiently aligned with the needle holder head to receive the needle holder within the needle retraction chamber, a bias member, such as a compressed spiral spring, arranged inside the body, it propels the needle and needle holder backwards, simultaneously removing the beveled front tip of the needle, so that it no longer protrudes in front of the body of the front accessory. When the needle retraction chamber slides laterally in relation to the needle, the annular fluid seal reduces the likelihood of any leakage of fluid from the subject's medical device due to fluid flowing out of the associated medical device after use.
[0020] The medical device of the subject provides numerous benefits and advantages when compared to the devices of the prior art. One such benefit is that the retraction of the needle can be activated independent of aspiration, so that, for example, the fluid can be withdrawn from a needle and the needle can still be retracted without fully lowering the plunger cable. Another benefit is that the subject's medical device is configured to retract the needle directly from a patient without first having to manually remove the needle and risk possible contamination by exposure to body fluids containing infectious pathogens. The retraction of the needle can be initiated after the injection of a partial dose. Greater control can be exercised by the clinician using the invention because the retraction is initiated by applying pressure closer to the base of the device, thereby reducing the likelihood of the needle "oscillating" in the patient.
[0021] In an embodiment of the invention, the medical device of the subject is also provided with a needle cap or needle cover that reliably fits the body and locks the connector housing in a position where it cannot be moved sufficiently to allow premature activation of the needle retraction mechanism, without first removing the needle cap. If desired, the subject medical device can itself be used as a cap, closure or cap for a pre-filled syringe. When done in combination with a syringe tube, for example, the front fitting of the subject can be used to completely pull a dose of expensive or caustic medications or remedies and then capped for later use, to avoid waste or injury. While the cap or needle cover is in position, the medical device of the invention can also be conveniently carried in a pocket or secured within or over it, particularly when configured as described below.
[0022] If desired, the medical device of the subject may be rigidly attached to, integrally molded with or otherwise manufactured or assembled with at least part of an associated medical device. As an example, the connector housing and syringe tube are individually or integrally molded from a medical grade, moldable polymeric resin. As another example, a syringe tube is otherwise fixed or connected in substantially fixed relation to the connector part of the connector housing and is arranged in substantially coaxial alignment with the needle retraction unit and the needle, before the movement of the connector housing in relation to the frontal accessory after use, but before retracting the needle. In this embodiment, the substantially parallel longitudinal geometrical axes, centrally arranged through the needle retraction chamber and needle retraction chamber, are still desirably spaced laterally apart from each other, even if the needle retraction chamber and the needle tube are unitary or integrally molded, in such a way that they are side by side, with no open space between them, so that part of the needle retraction chamber and part of the syringe tube share a common wall. Several benefits can be achieved through the use of this embodiment and it can be packaged and sold in combination with a plunger and plunger seal that cooperate to create a fluid chamber of varying volume within the device that is aligned with the needle and enable that the device is used to inject or withdraw fluids through the needle under positive or negative pressure.
[0023] The frontal accessory of the invention can also be used with needles and syringes of different and variable calibers and sizes, without special modification. If desired, the associated medical device with which the subject medical device is used, or the doctor himself, can be provided with a buffer containing an anticoagulant, such as heparin, for use in blood gas applications. The structure and operation of the invention is simplified by the provision of a substantially linear fluid flow path and a needle retraction chamber and associated retraction chamber, which are displaced laterally from the fluid flow path during fluid injection or extraction. The medical device of the subject has few parts and these are easy and not inexpensively shaped.
[0024] The medical device of the invention also incorporates safety details that are not typically available in many prior art devices. For example, the subject device is effectively “locked locked” against reactivation and reuse by the spring and needle, which encompass the chamber and needle retraction body together after retraction. The lateral movement and associated sliding repositioning of the needle retraction chamber, in relation to the fluid flow path through the connector housing, and the presence of a fluid seal between the body and connector housing, cooperate to interrupt the flow path and avoid backflow of fluid from an associated medical device after use. After the needle is retracted, the subject's medical device can be removed from the associated medical device and discarded as with other needle covers. In circumstances where the associated medical device is reusable, it can be autoclaved, sterilized or otherwise processed for possible reuse, regardless of the component containing the needle.
[0025] Other benefits and advantages of the medical devices of the subject will also become more evident for those of ordinary skill in the technique, when reading this description in relation to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The apparatus of the invention is further described and explained in relation to the following drawings, in which: Fig. 1 is a perspective view from the right front of an embodiment of the medical device of the invention, with the needle cover installed ; Fig. 2 is a perspective view from the front of the medical device of Fig. 1; Fig. 3 is the medical device as in Fig. 1, with the needle cover removed; Fig. 4 is the medical device as in Fig. 2, with the needle cover removed and before the needle retracts; Fig. 5 is an exploded front perspective view of the medical device as in Fig. 1 (exploded along the longitudinal geometric axis through the retractable needle unit of the front accessory and the connector part of the connector housing); Fig. 6 is a front elevation view of the medical device of Figs. 1 and 2; Fig. 7 is a front elevation view of the medical device of Figs. 2 and 3, with the needle cover removed; Fig. 8 is a rear elevation view of the medical device of Fig. 7; Fig. 9 is a top plan view of the medical device of Fig. 1; Fig. 10 is a right side elevation view of the medical device of Fig. 1; Fig. 11 is a cross-sectional plan view of the medical device in a pre-use position, taken along line 11 - 11 of Fig. 10 and also showing in schematic outline a conventional luer locking syringe attached to the housing subject medical device connector; Fig. 12 is a top plan view of the medical device and syringe of Fig. 11, with the syringe again shown in schematic outline; Fig. 13 is a cross-sectional plan view of the medical device as in Fig. 11, but with the needle cover removed and the needle plunger removed to an aspirated position; Fig. 14 is a top plan view as in Fig. 12, but with the needle cover removed and the needle plunger removed to an aspirated position; Fig. 15 is a top plan view as in Fig. 13, but with the syringe plunger fully lowered to a post-injection position and with the needle fully retracted. Fig. 16 is a perspective view from the right front of the subject's medical device, following the separation of a syringe and with the needle in the fully retracted position; Fig. 17 is a right side elevation view of the medical device of Fig. 16; Fig. 18 is a top plan view of the medical device, taken along line 18 - 18 of Fig. 17; Fig. 19 is a rear elevation view of the medical device of Fig. 16; Fig. 20 is a left rear perspective view of the body part of the front attachment; Fig. 21 is a rear, right perspective view of the body part of the front attachment; Fig. 22 is a side elevation view in cross section along line 22 - 22 of Fig. 6; Fig. 23 is a perspective view from the left front of the medical device as in Fig. 4, but with the needle cover removed and following the retraction of the needle; Fig. 24 is a perspective view from the right front of another embodiment of the medical device of the invention, in which the associated medical device is a syringe having a body part that is integrally molded as part of the connector housing and in which the removable needle cover, as shown in relation to the embodiment described above, is not shown. Fig. 25 is a perspective view from the right front as in Fig. 24, in which a plunger cable of the associated medical device is fully lowered and the needle is retracted; Fig. 26 is a right side elevation view of the medical device as in Fig. 24, but with the needle cover shown; Fig. 27 is a top plan view in cross section of the medical device as in Fig. 26; Fig. 28 is an exploded front perspective view of the medical device as in Fig. 26; Fig. 29 is a top plan view in cross section along line 29 - 29 of Fig. 31, showing the needle in the post retraction position; Fig. 30 is a front elevation view of the medical device of Fig. 26; Fig. 31 is a front elevation view of the medical device of Fig. 26, following the removal of the needle cover and also following the retraction of the needle; Fig. 32 is a rear elevation view of the medical device of Fig. 30; Fig. 33 is a rear elevation view of the medical device of Fig. 31, following the removal of the needle cover and also following the retraction of the needle; Fig. 34 is a perspective view from the right front of another embodiment of the subject medical device, in which a syringe tube is molded together with the connector housing of the invention and showing a removable needle cover in position over the needle retractable and a plunger inserted into an opening in the rear of the syringe tube; Fig. 35 is the medical device of Fig. 34 with the needle cover removed and the retractable needle projecting forward from the front attachment in the position of use; Fig. 36 is the medical device of Fig. 35, with the plunger cable more fully lowered into the syringe tube and with the needle retraction chamber and needle retraction chamber moved laterally with respect to the front attachment and retracted needle ; Fig. 37 is an exploded right perspective view of the medical device of Fig. 34; Fig. 38 is a right side elevation view of the medical device of Fig. 34; Fig. 39 is a top plan view in cross section of the medical device of Fig. 38; Fig. 40 is a top plan view of the medical device of Fig. 39, with the needle cover removed; Fig. 41 is a top plan view of the medical device in Fig. 40, with the plunger more fully lowered into the syringe tube, with the connector housing repositioned laterally in relation to the front fitting to align the needle retraction chamber and needle retraction chamber with the needle retraction unit and the retracted needle; Fig. 42 is a top plan view in cross section of the medical device of Fig. 41; Fig. 43 is a rear elevation view of the front accessory of the medical device of Fig. 37; and Fig. 44 is a cross-sectional view taken along line 44 - 44 of Fig. 43, with parts removed to simplify the view and better illustrate the resilient polymeric fasteners used to slide the front attachment into the base of the connector housing. . DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] With reference to Figs. 1, 2 and 10, medical device 30 comprises connector housing 32, front accessory 34 and locking needle cover 36. Referring to Figs. 3, 4 and 9, the locking needle cover 36 is removed to reveal the needle 38 with a beveled end facing upwards 40. Referring to Figs. 5 and 9, the connector housing 32 of the medical device 30 desirably further comprises needle retraction chamber 42 having closed end facing backward 44 and opening facing forward 46 limiting with retraction chamber 58. Opening 46 is desirably shaped elongated or oval, with a transverse dimension greater than the internal diameter of the elongated cylindrical part of the needle retraction chamber 42. As seen in Figs. 5 - 8, the opening 46 desirably transitions along the tapered inner wall 102 (rear 103 visible in Fig. 8) to the inner diameter of the needle retraction chamber 42. The tapered inner wall 102 facilitates insertion and removal of the arm locking mechanism 98 of the locking needle cover 36 and also facilitates the entry of the needle holder 72 and retraction spring 80 into the retraction chamber 58 during the retraction of the needle, as is discussed in more detail below. If desired, the closed end 44 may also comprise a small opening (such as for ventilation purposes), provided that it is not large enough to allow the needle retraction spring 80, needle holder 72 or needle 38 to exit through the rear of the needle retraction chamber 42.
[0028] As shown in Fig. 5, connector housing 32 desirably further comprises connector 48 for use in connecting medical device 30 to an associated medical device, such as, for example, syringe 104, which is shown and described in relation to to the medical device 30 of Figs. 11 - 15. Connector 48 comprises a substantially cylindrical side wall, having an internal fluid flow path 54 with opening facing forward 52 and open end facing rear 50. Two luer locking lugs projecting radially, diametrically opposed 56 are provided near the rear end 50 for use in attaching connector 48 to an associated medical device. The forward facing opening 52 desirably further comprises a lowered annular fixing surface for receiving fluid seal 68. Fluid seal 68 also desirably comprises a centrally disposed fluid flow path 70, which is coaxial with the fluid flow path. 54 through connector 48. With reference to Figs. 4 and 6 - 10, a textured digital contact surface 100 is desirably but optionally provided on the surface facing out of the needle retraction chamber 42, to facilitate the application of manual force (indicated by arrow 35 in Fig. 4) to the housing connector 32 for use when initiating needle retraction, as discussed below.
[0029] Still with reference to Fig. 5, the front accessory 34 of medical device 30 further comprises a base 82 and a needle holder projecting forward 84. The needle holder 84 preferably has a plurality of tapered ribs, spaced apart between si 88, to provide releasable frictional fit with the inner side of collar 97 of the locking needle cover 36, although it is appreciated by those of ordinary skill in the art, when reading this description, that other similarly effective means can be provided to release reliably secure the locking needle cover 36 to the needle holder 84. With reference to Figs. 5 and 20 - 22, the base 82 and needle holder 84 desirably comprise a stepped inner bore 86. With reference more particularly to Figs. 20 - 21, the base 82 further comprises a back facing surface 87 with an opening into the stepped inner hole 86, which desirably comprises an annular recess configured to receive and place the larger diameter head portion 76 of the needle holder 72 ( visible in Fig. 5) when the needle retraction mechanism (Fig. 5), comprising the compressed spring 80 and the needle holder 72, is inserted in the front fitting 34 before fixing the front fitting 34 in the connector housing 32. One textured contact surface facing out 90 is desirably but optionally provided at the end of the base 82 for use in applying a force as indicated by the arrow 45 of Fig. 4 during needle retraction, as discussed in more detail below. The force applied to the front attachment 34 can be a resistive force and preferably comprises a main component that is opposite or opposite to the applied force as indicated by the arrow 35 in relation to the connector housing 34.
[0030] With general reference to Figs. 1 - 23 and, more specifically, to Figs. 5 - 8 and 19 - 23, during the assembly of the medical device 30, the front end of the spiral spring 80 is desirably inserted into and placed into the hole 86 and the elongated tubular shaft part 74 of the needle holder 72 is desirably inserted into the spiral spring 80 and forced downward to compress the spring and allow the larger diameter head 76 of the needle holder 72 to be placed into the hole 86. This causes the compressed spring 80 to exert a directed biasing force back against the underside of the head 76. The needle holder 72 desirably comprises a longitudinally extending hole 78, which is placed in fluid communication with the needle 38 when the needle 38 is installed inside the part extending in front of the hole 38. According to an embodiment of the invention, a shallow recess is provided at the end facing behind the head 76 of the needle holder 72 (not visible in Fig. 5) to loosely fit in the end f igniting in front of the fluid seal 68 when the medical device 30 is mounted. As shown in Figs. 3 and 4, the end extending to the front of the needle holder 72 desirably extends slightly beyond the tip extending to the front of the needle holder 84 to facilitate attachment of the needle 38 to the needle holder 72 following installation from the needle retraction mechanism and attachment of the front attachment 34 to the connector housing 32 by any suitable conventional method, known to those skilled in the art. Although needle 38 may be attached to needle holder 72 before or after installation of needle holder 72 within the front fitting 34, fixation after installation of the needle retraction mechanism is preferred.
[0031] Following the insertion of the fluid seal 68 into an annular recess within the opening facing forward 52 of the connector housing 32 (as mixed, for example, in Figs. 5 and 22) and while retaining the needle holder 72 inside the front attachment 34 against the backward biasing force exerted by the compressed spring 80, the back facing surface 87 of the base 82 of the front attachment 34 is positioned opposite the forward facing surface 60 (seen in Fig. 5) of the housing connector 32. The front facing surface 60 of the connector housing 32 is desirably configured to face and slide into the rear 87 of the base 82, when the opposite rails 64, 66 (Figs. 5, 8 and 19 - 23) of the connector housing they cooptively fit in the opposite rails 91, 93, respectively, of the base 82. The rails 64, 66 and 91, 93 are desirably made so that they can fit in a sliding fit when the connector housing 32 and front accessory 34 s They are retained in facet parallel alignment, so that the hole 86 is disposed opposite the opening 52, and tightened together applying force in front of the front accessory 34 and in the back of the connector housing 32, simultaneously. When the front fitting 34 is attached to the connector housing 32, the fluid seal 68 is pressed in limiting contact with the backward facing end of the needle holder head 76. The annular fluid seal 68 desirably prevents leakage of fluid between the connector housing 32 and front accessory 34 during use of the medical device 30 and a medical device 30 and an associated medical device before repositioning the connector housing 32 in relation to the front accessory 34 before retracting the needle.
[0032] With reference to Figs. 5, 17 and 20, the stop members 62, 63 are desirably provided to engage in limiting contact with the opposing upper and lower shoulders (lower shoulder 65 visible in Fig. 20) of the surface 87 adjacent to the base 82 of the front fitting 34, to limit or restrict the range of lateral sliding movement of the connector housing 32 in relation to the front accessory 34, to avoid accidental separation. When the medical device 30 is assembled as described, the head 76 of the needle holder 72 (Fig. 5) is placed inside the recess 86 (Figs. 19 - 20 of the front attachment 34 and a substantially linear fluid path is desirably defined through from hole 54 of connector 48, hole 70 of fluid seal 68, hole 78 of needle holder 72 and needle 38.
[0033] With reference to Figs. 1 - 3, 5 - 6 and 11, the locking needle cover 36 desirably comprises a substantially cylindrical side wall 92, having closed end 94, open end 96 and a plurality of longitudinally extending ribs extending to provide necessary rigidity to protect needle 38 from damage before use. The locking arm 98 desirably projects backwards from the collar 97 of the locking needle cover 36 and is configured to be insertable into the opening 46 of the connector housing 32 to limit the relative sliding movement between the connector housing 32 and the front attachment 34, prior to removal of the locking needle cover 36 from the needle holder 84. Other similarly effective locking structures can also be provided within the scope of the invention and we have noted that such locking structures are not necessary to be part of the cover of the invention. needle. Figs. 6 and 7, respectively, show the medical device 30 as seen from the front with and without a locking needle cover 36 in position.
[0034] With reference to Figs. 11 - 15, An associated medical device is shown in schematic outline, in combination with the medical device 30 of the invention. The associated medical device is a conventional syringe 104, having a generally cylindrical tube 106 with a luer locking connector facing forward and a plunger 108 having a plunger seal slidably engaging the inner wall of the tube. Plunger 108 cooperates with tube 106 to define a fluid chamber of varying volume 110 within the syringe, which can supply fluid to needle 38 through the fluid path through medical device 30, as described above. As shown in Figs. 11 and 12, medical device 30 and syringe 104 are shown in fully assembled form, with needle cover 36 in position over needle 387. Plunger 108 is shown in a position relative to tube 106, which can be termed a affixing a 'pre-injection', such as one in which a conventional syringe without a needle could be packaged and shipped before use.
[0035] With reference to Figs. 13 and 14, the fully assembled medical device of Figs. 11 and 12 is shown again with the needle cover removed and the plunger 108 removed to a position, such as that in which the fluid was aspirated into the fluid chamber 110. Such aspiration could occur, for example, by pulling fluid into the syringe of a vial or other fluid source, or extracting a fluid sample from a patient (following the expulsion of air from the fluid chamber 110). For pre-filling use, syringe 104 can be filled to the desired level and packaged for shipment with or without medical device 30 already in position.
[0036] With reference to Figs. 13 and 15, after the use of the fully assembled medical device, the retraction of the needle is desirably achieved within the medical device 30 by repositioning the connector housing 32 in relation to the front accessory 34, so that the needle retraction chamber 42 is moved to coaxial alignment with needle 38. This can be done, for example, by manually applying pressure (as indicated by the arrow 35 in Fig. 4) to the optionally provided contact surface 100 of the connector housing 32, while stabilizing the tube 106 and front fitting 34 and / or applying resistance pressure (as indicated by the arrow 45 in Fig. 4) to the optionally provided contact surface 90 of the front fitting 34. If needle 3 is not inserted into a patient in the When the needle is retracted, the front accessory 34 and connector housing 32 can be repositioned in relation to each other, applying manual pressure opposite to the contact surfaces 90 and 100 or to other parts of the front accessory. such 34 and connector housing 32. Applying pressure as described above will cause the fluid seal 68 and connector housing 32 to move from a first position (Fig. 13) in which syringe 108 is aligned with needle 38 in a second position (Fig. 15) in which the needle retraction chamber of the connector housing 32 is aligned with needle 38. When this repositioning occurs, the propensity force directed backwards 80 will cause needle holder 72 and needle 38 to enter opening 46 when they are sufficiently aligned to allow full retraction. Similarly, if desired, the medical device 30 can also be constructed by providing the connector housing 32 in relation to the front accessory 34, so that the proposed repositioning allows the retraction of the needle to occur when applying a firing force on a cooperatively configured release element.
[0037] In Fig. 15, the fully assembled medical device of Figs. 13 and 14 is shown again with the plunger 108 fully lowered into the tube 106 as it could be after an injection, with the connector housing 32 repositioned in relation to the front fitting 34 from the position shown in Fig. 14 and with the support of needle 72, spring 80 and needle 38 all retracted into the medical device 30 in a safe position, without part of the needle 38 still projecting forward from the front attachment 34. Following retraction, the expanded spring and the needle retracted can provide a “bridge” connection between the front attachment 34 and the connector housing 32, which will stop the removal of the front accessory 34 from the connector housing 32, to reconfigure the medical device 30 to its pre-retract state, and will also stop the reverse movement of the connector housing 32 with respect to the front accessory 34, which could otherwise realign a fluid path through the medical device 30.
[0038] In Figs. 16 - 18, syringe 104 has been separated from medical device 30 by unscrewing the luer locking connector, and medical device 30 is ready for safe disposal. In Fig. 18, it is seen that the fluid seal 68 remains in limiting contact with the rear side of the base 82 of the front fitting 34 around the bore 70, following the retraction of the needle.
[0039] The connector housing 32, front accessory 34 and needle cover 36, of the medical device 30, are all desirably made of any moldable polymeric material, approved for such medical applications and for sterilization. The fluid seal 68 is desirably made of an elastomeric polymeric material, having a composition and durometer that are satisfactory for containing fluids within the fluid path, between the connector housing 32 and the front fitting 34, without degradation, before and during the use, and which will allow disengagement of the needle holder 72 and relative sliding movement between the connector housing 32 and the front accessory 34, when the seal 68 and needle retraction chamber 42 are repositioned laterally before the needle retraction. Needle 38 is preferably made of stainless steel, another metal or alloy, or a ceramic or other material that is approved for such use. Compression springs are made of metal, are generally known in the industry and are readily available from commercial vendors.
[0040] Another embodiment of the subject invention is described in relation to Figs. 24 - 33 of the accompanying drawings. With reference to Figs. 24 and 25, a medical device 200 is described in which an associated medical device, in this case syringe tube 222, is provided as a unitary part of the connector housing. The medical device 200 desirably comprises the front accessory 204 and the connector housing 202, which are selectively fixed to each other and are held by one or more fixing members in a sliding relation closely spaced from each other along at least one sliding interface allowing lateral movement limited slide between the front accessory 204 and the connector housing 202, as previously discussed in relation to the embodiment of Figs. 1 - 23. In Fig. 24, the needle cover (shown and described in relation to Figs. 26 - 28 below) is removed to reveal needle 210 in Fig.
[0041] Front attachment 204 desirably further comprises body 206, nose extending forward 208, retractable needle 210 and textured contact surface 214. Connector housing 202 further comprises base 216, needle retraction chamber 218 and tube syringe 222. In Fig. 24, the needle cover (shown and described in relation to Figs. 26 - 28 below) is removed to show a first position where tube 222 is coaxially aligned with needle holder 208, chamber laterally displaced needle retraction 218 and needle retraction chamber 220 having a forward facing opening, which is unobstructed. In Fig. 25, the connector housing 202 has been moved laterally with respect to the front attachment 204, to a second position in which the needle retraction chamber 218 is substantially aligned with the needle holder 208, and the needle 210 (no longer visible ) was retracted into the needle holder 208 and the needle retraction chamber 220 (Fig. 24) into the needle retraction chamber 218.
[0042] In this embodiment of the invention, an associated medical device, such as syringe tube 222 (or other associated medical device previously mentioned in this description) is rigidly connected to and part of the connector housing. In parts made with a moldable medical grade material, this substantially rigid connection can be achieved by any suitable method, such as, for example, by unitary or integrally molded connector housing 202, comprising base 216, needle retraction chamber 218 and syringe tube 222 as a single unit, or using other known technologies of similar effect, including, without limitation, the use of laser welding or adhesives. When the medical device 200 is configured in this way, the needle retraction chamber 220 is considered to be laterally spaced from the tube 222, even though the needle retraction chamber 218 and tube 222 share a common wall (best seen in Fig. 27) . We have also observed that the medical devices of the invention, having an associated medical device attached, can be produced in which the needle retraction chamber and the associated medical device do not share a common wall. Referring again to Figs. 24 and 25, laterally projecting tube flanges 224, 226 can also be integrally molded together as part of tube 222 or can be separately manufactured and fixed to the tube by conventional methods. Plunger 228 is slidably disposed within barrel 222 and is shown in Fig. 24 in a typical position relative to tube 222, how it could be shipped and stored before use. As shown, plunger 228 comprises cable 230 and end cap 232 and plunger seal 238 (visible in Figs. 27 - 29). In Fig. 25, the plunger cable 230 is more fully lowered in relation to tube 222, as it would be in an injection application. For other applications, such as withdrawing body fluid from a patient, the plunger cable can also be removed a greater distance from tube 222 than shown in Fig. 24, when needle 210 is retracted.
[0043] With reference to Fig. 27, the removable needle cover 234 is shown installed on the medical device 220, with the locking arm 236 protruding into the needle retraction chamber 220, to limit the relative sliding movement between the body 206 of the front accessory 204 (Fig. 26) and the base 216 of the connector housing 202 (Fig. 26) during shipping and handling before use. Without locking arm 236 or similarly effective structure retaining needle 210 in substantial coaxial alignment with fluid path 244 and fluid chamber 240 of tube 222 prior to use, premature lateral displacement of front attachment 204 and / or connector housing 202 in relation to the other it could realign the retractable needle unit comprising the needle holder 246 and compressed needle retraction spring 250 with the needle retraction chamber 220 sufficiently to allow the spring 250 to expand and impel the needle holder 246 and needle 210 back into needle retraction chamber 220.
[0044] With reference to Figures 27 - 28, the medical device 200 desirably further comprises annular piston seal 238 disposed at the facing end of the piston cable 230, to provide sliding and sealing fit with the inner wall of the tube 222 (Fig . 28). With reference to Fig. 28, the connector housing 202 desirably further comprises the laterally spaced openings, facing forward 221 and 248. The opening 221 is provided to receive the needle holder 246 and expanded needle retraction spring 250 during retraction of the needle following the repositioning and realignment of the connector housing 202 in relation to the front accessory 204. The upper and lower stop members 245 and upper and lower rails 223 (lower rail not visible) are desirably provided to facilitate the assembly of the front accessory 204 in the housing connector 202, provide at least one side sliding interface between them, which is substantially transversal to the longitudinal geometric axis through needle 210 and tube 222, and provide cooperatively aligned stop members and locking structures, which prevent accidental disassembly, as described in greater detail details above in relation to the first embodiment described. In one embodiment, the stop members 245 and the upper and lower rails 223 are cooperatively configured, so that the front attachment 204 can be fitted in a sliding fit with the connector housing 202 and remain in a sliding fit within one another. predetermined displacement range. The predetermined displacement range is desirably sufficient to allow movement between a first or initial position, where needle 210 is aligned with tube 222 and a second or subsequent position, where needle 210 is aligned with needle retraction chamber 218 .
[0045] With reference to Figs. 27 - 29 and 32, a fluid seal, such as an annular fluid seal 242, is desirably provided to prevent fluid leakage around fluid path 244 (Fig. 27) between opening 248 of connector housing 202 and a extreme annular surface facing backward from the needle holder 246. In this embodiment, the fluid seal 242 is desirably made of a medical grade elastomeric material and is placed within the opening 148 of the base 216 of the connector housing 202. The length, radius, durometer of the fluid seal 242 and the internal diameter of the fluid path 244, through the fluid seal 242, are desirably so that the facing face of the fluid seal 242 can be compressed against the needle holder head 246, without blocking or excessively restricting the flow of fluid through the fluid path 244 during use. Referring to Fig. 29, following the use of medical device 200, fluid seal 242 is desirably carried by connector housing 202 when connector housing 202 is repositioned in relation to front attachment 204 to initiate retraction. During this repositioning, the forward facing end of the fluid seal 242 is desirably moved away from the needle holder 246 and into the fluid tight housing with the opposite facing face of the 206 body (Fig. 32) of the front fitting 204, to prevent any fluid leakage or reflux from syringe 222. Although the use of an annular fluid seal 242 as described herein is preferred, other similarly effective fluid seals may also be employed within the scope of the invention.
[0046] With reference to Figs. 29 - 33, following the repositioning of connector housing 202 from the first position to the second position, as discussed above, the needle retraction spring 250 expands behind the needle holder 208 and pushes the needle holder 246 back inside the needle retraction chamber 220 inside the chamber 218, thereby retracting the front end of the needle 210 into the needle holder 208 or needle retraction chamber 220. The relative lengths of the needle holder 208, retraction chamber needle 220 and needle retraction spring 250 are desirably sized cooperatively according to the range of needle lengths with which the medical device 200 is anticipated to be used.
[0047] Although the medical device described here in relation to the embodiment of Figs. 24 - 33 is in many respects similar to that described in relation to the embodiment of Figs. 1 - 23, medical device 200 offers several distinct advantages, which are only available in an embodiment in which an associated medical device, such as a syringe, is made as an integral part of the medical device. More particularly, the presence of a syringe tube, in combination with a plunger, such as a plunger 228, having a slide fluid seal, such as a plunger seal 238, allows the creation of a fluid chamber of varying volume, such as as a fluid chamber 240, within a device. In addition, the user is provided with the ability to create positive or negative pressure within a fluid supply or extraction device, having a retractable needle and a needle retraction chamber that is not disposed at any time within the fluid path. . This configuration allows a user to infuse or extract variable volumes of various fluids having various viscosities at varying pressures for the intended application, without the risk of explosion or premature needle retraction. In addition, the subject device provides all the safety benefits associated with the use of one hand and retraction with a needle that can be retracted directly from a patient after use and in a safe position, where the needle cannot be reused. In addition, the simple and compact design, with few moving parts and lower manufacturing and assembly costs, will hopefully increase its potential for widespread use.
[0048] Another embodiment of the invention of the subject is described in relation to Figs. 34 - 44 of the accompanying drawings. This embodiment is similar to the embodiment of Figs. 24 - 33 in that it comprises a part of an associated medical device which is an integral part of the connector housing. In the embodiment shown in Figs. 34 - 44, the associated medical device is a syringe. With reference generally to those drawing figures, the medical device 300 desirably comprises a connector housing 302 and front accessory 304. The connector housing 302 further comprises a generally cylindrical tube 306 and needle retraction chamber 310 which are molded or otherwise manufactured as a unitary or unified structure, along with base 326 (Fig. 37). The base 326 desirably comprises openings facing forward, laterally spaced into the needle retraction chamber 320 and into the cylindrical bore 334, which communicate with the fluid chamber 352 (Fig. 39) disposed within the tube 306. Stop members Opposites 328, 330 (Fig. 37) are provided to limit the travel range of the connector housing 306 (Figs. 34 - 36) with respect to the front accessory 304 during retraction of the needle, as discussed above in relation to the medical device 200 of the Figs. 24 - 33. As shown in Figs. 34 - 42, the plunger cable 308, with plunger seal facing forward 324, is desirably slidable inside the tube 306 and can be inserted or removed in relation to the tube 306 to vary the volume of the fluid chamber 352 when necessary for suction , injection or extraction through the fluid path 354 (Fig. 39), communicating with the front end of the fluid chamber 352.
[0049] With reference to Figs. 34 - 37, 43 and 44, the front accessory 304 desirably further comprises the body 312 having a pair facing backwards of opposing fastening members, upper and lower, laterally disposed 315, having chamfered surfaces, adapted to slide over and fit into place side slide, with upper and lower rails disposed between opposing stop members 328, 330 of base 326 of body 312. As seen in Fig. 44, the square shoulder arranged on the back of each of the upper and lower holding members 315 desirably maintains the front accessory 304 in sliding fit with the body 312 along at least one sliding interface extending laterally. The annular fluid seal 336 (Figs. 37, 39 and 42) is desirably provided between the connector housing 302 and the front fitting 304, to limit fluid leakage between them, when slidably fitted and when the medical device 300 is being used .
[0050] With reference more particularly to Figs. 37, 39 and 42, front attachment 304 also desirably comprises a needle retraction mechanism comprising needle holder 338 and fixed retractable needle 340 and a bias member, such as a spiral spring 342 exerting a bias force directed backwards against needle holder 338, to facilitate withdrawal of needle 340 from a patient, vial or other fluid source or receptacle, during needle retraction, as discussed below. The front end of the spring 342 is desirably placed inside the nose 344 and the elongated part of the needle holder 338 is desirably inserted into the spring 342 and the spring 342 is desirably maintained in compression until the front fitting 304 is fitted with the base 326 connector housing 302 during assembly. The annular fluid seal 336 is desirably placed inside the cylindrical bore 334 (Fig. 37) before the attachment of the front fitting 304 to the connector housing 302 and the facing face of the needle holder 338 is desirably compressed into a limiting fit with the part facing the seal 336 by the compressed spring 342.
[0051] Before use, the removable needle cover 314 (Figs. 34 and 37 - 39) is desirably installed in a frictional fit with the nose 344 (Fig. 37) of the body 312 to protect the needle 340 from being blunted or contaminated and to protect that medical device handling 300 from an inadvertent needle stick prior to use. As shown, the needle cover 314 desirably comprises the locking arm projecting forward 3128, which is received within the front opening of the needle retraction chamber 320 and prevents premature relative sliding movement between the connector housing 302 and the accessory 304 before use. It will be noted, however, when reading this description, that other similarly effective braking devices can also be provided and used to prevent premature lateral displacement or repositioning of the connector housing 302 in relation to the front accessory 304 of the medical device 300 prior to use.
[0052] The front accessory 304 desirably further comprises the textured surface facing laterally 322, configured for use in applying pressure or resistance force in a direction transverse to the direction of fluid flow through needle 340 and fluid path 354, to start the retraction of the needle after use. Such pressure or resistance, when combined with oppositely directed pressure, applied to some part of the connector housing 302, facilitates the lateral repositioning of the connector housing 302 relative to the front accessory 304, to interrupt the flow of fluid through the fluid path 354 and start the needle retraction after use. The lateral movement of the connector housing 302 in relation to the front accessory 304 disengages the face facing face of the annular seal 336 from the facing face of the needle holder 338 and causes the annular seal 336 to slide laterally to engage with the facing face to behind the body 312, thereby completely blocking any flow of fluid in front of the syringe tube 306 or cylindrical bore 334, subsequent to such repositioning.
[0053] The relative lateral movement between the connector housing 302 and the front accessory 304 is limited to move between a first position (Fig. 35), where the needle 340 extends forward from the front accessory 304, in substantially alignment coaxial with the syringe tube 306 and a second position (Fig. 36), where the needle is retracted to a safe position after use and no longer protrudes forward from the nose 344 (Fig. 37) and body 312 When the back facing head of needle holder 338 moves to substantial coaxial alignment with the forward facing opening within needle retraction chamber 320 of needle retraction chamber 310, the biasing force directed backward from the spring 342 forces the needle holder 338 back to the closed rear end of the needle retraction chamber 310. The rear end of the needle retraction chamber 310 can be vented if desired, as long as the needle holder 338 remains. the one captured inside the needle retraction chamber 310. Because the spring 342 and needle 340 fill the gap between the needle retraction chamber 310 and the body 312 of the front attachment 304, the front attachment 304 is then held in the second position and cannot be returned to the first position without impermissibly disassembling the used medical device 300.
[0054] Importantly, the medical devices described here can be manufactured and assembled with greater tolerances than are otherwise required for conventional medical devices, having plunger-activated retractable needles, with an associated reduction in manufacturing cost that can provide a basis for sale at lower costs to medical providers and consumers. Other benefits are also associated with having a needle retraction chamber laterally spaced and a sequence of operation that does not require cutting, breaking or the use of retaining or retaining members disposed between the needle retraction mechanism and the wall of the needle. a syringe tube.
[0055] Although the luer connectors and compression springs are suitable for use in the present invention, it should be understood that other connectors and bias members can also be used, provided that they otherwise satisfy the general parameters of the invention, as described and claimed here. Other changes and modifications of the invention will also become apparent to those skilled in the art when reading this report, in view of the accompanying drawings, and it is intended that the scope of the invention described here be limited only by the broadest interpretation of the claims annexes, to which inventors are legally entitled.

权利要求:
Claims (11)
[0001]
1. Medical device (30) comprising: a connector housing (32) and a front accessory (34) connected to the connector housing (32), the connector housing (32) and the front accessory (34) being cooperatively engaged in a close sliding relationship spaced apart from each other along at least one sliding interface; a needle retraction unit placed within the front accessory (34), the needle retraction unit comprising a rearwardly propelled needle holder (72); a retractable needle (38) projecting forward from the front attachment (34); and a fluid seal (68) disposed between the connector housing (32) and the front accessory (34); the connector housing (32) further comprising at least a body part of an associated medical device (104) and a fluid path communicating with the needle holder (72) through the fluid seal (68), and a fluid chamber needle retraction (44) having a needle retraction chamber that is located laterally away from the fluid path, characterized by the fact that the connector housing (32) still comprises a forward facing surface (60) and rails (64, 66) , a first opening (52) communicating with a backward facing connector (48), and a second opening (46) into the needle retraction chamber (58), where the connector (48) has luer locking tabs ( 56) provided near the rear end (50) for use in attaching the connector (48) to an associated medical device and where the associated medical device is a syringe (104) having a generally cylindrical tube (106) with a locking connector luer facing forward and a plunger (108); the front accessory (34) still comprises base (82) and needle holder projecting forward (84), where the base (82) has a back facing surface and a plurality of cooperatively fitted rails (91, 93) which can be fitted in a slide-in slot with rails (64, 66) of the connector housing (32) along at least one sliding interface, and in which at least one sliding surface surface is substantially transversal to a longitudinal axis through the retractable needle (38).
[0002]
Medical device (30) according to claim 1, characterized in that the fluid seal (68) limits fluid leakage around the fluid path between the connector housing (32) and the front accessory (34) ) both before and after the needle retraction.
[0003]
Medical device (30) according to claim 1 or 2, characterized in that the fluid seal (68) is an annular seal placed in a recess arranged around a part of the fluid path of an opening ( 52) with the front facing the connector housing (32).
[0004]
Medical device (30) according to claim 2 or 3, characterized in that the fluid seal (68) contacts an end with the front facing behind the needle holder (72).
[0005]
Medical device (30) according to any one of the preceding claims, characterized in that it comprises a stop (62, 63) that limits the relative movement of the connector housing (32) and the front accessory (34) in relation to along the sliding interface.
[0006]
Medical device (30) according to any one of the preceding claims, characterized in that the connector housing (32) has a first position relative to the front accessory (34), in which the needle retraction unit is coaxially aligned with the fluid path.
[0007]
Medical device (30) according to any one of the preceding claims, characterized in that the connector housing (32) has a second position relative to the front accessory (34), in which the needle retraction chamber (44) it is substantially coaxially aligned with the needle retraction unit, preferably the connector housing (32) has a second position relative to the front accessory (34) in which at least part of the needle and needle retraction unit (38) are disposed within the needle retraction chamber (58).
[0008]
Medical device (30) according to any one of the preceding claims, characterized in that it further comprises a selectively removable needle cover (36).
[0009]
Medical device (30) according to claim 8, characterized by the fact that the needle cover (36) further comprises a locking arm (98) which is interlockable with the connector housing (32), preferably the locking arm locking (98) limits the relative sliding movement between the connector housing (32) and the front accessory (34).
[0010]
Medical device (30) according to claim 9, characterized in that the locking arm (98) of the needle cover (36) is inserted into an opening facing forward (46) of the retraction chamber of needle (42).
[0011]
Medical device (30) according to any one of the preceding claims, characterized in that the needle retraction chamber (42) has a forward-facing opening (46) that is not obstructed, and / or the needle retraction (42) has a rear end (44) that is closed or ventilated.

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AU2013399612B2|2019-05-02|

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法律状态:
2017-05-23| B03A| Publication of an application: publication of a patent application or of a certificate of addition of invention|

2018-11-13| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

2019-11-05| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

2020-11-24| B09A| Decision: intention to grant|

2021-01-26| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/12/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US201261737263P| true| 2012-12-14|2012-12-14|

US13/714,819|US9138545B2|2012-12-14|2012-12-14|Needle retraction apparatus|

US201361836723P| true| 2013-06-19|2013-06-19|

US14/020,465|US9956352B2|2012-12-14|2013-09-06|Combined medical device with sliding frontal attachment and retractable needle|

US14/020465|2013-09-06|

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