• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    LUER ACCESS DEVICE AND INTEGRATED CATHETER FIXATION It is a Luer type fixation device that comprises a Luer type adapter that has a septum and a catheter cap, in which the Luer type adapter additionally has a gasket. wedge to receive a base portion of a catheter. The Luer-type fixture additionally includes an insert element body in which a catheter threader that has a probe that is configured to advance a base portion of a catheter through the settling septum is slidably housed , the base portion of the catheter in the Luer type wedge seal as a tip portion of the catheter is inserted into a patient. The catheter threader additionally includes a needle adapter that has a needle that is threaded through the probe and catheter to assist insertion of the catheter into the patient. After inserting the catheter, the catheter threader is retracted inside the insertion element body, thereby removing the needle from the catheter and shielding a sharp tip of the needle inside the hair (...).
    公开号:BR112015005651B1
    申请号:R112015005651-2
    申请日:2013-09-10
    公开日:2021-02-17
    发明作者:Stephen Bornhoft
    申请人:Becton, Dickinson And Company；
    IPC主号:
    专利说明:

    [0001] [001] This disclosure generally refers to Luer-type devices and catheters. More specifically, this disclosure discusses a Luer-type access and integrated catheter fixation device that comprises an insertion body selectively coupled to a Luer-type adapter, in which the insertion body advances and rests a catheter on the Luer-type adapter while simultaneously accessing the patient with the catheter.
    [0002] [002] As used in the present invention, the term "Luer" means the description and inclusion of any Luer-type connection or other small-scale fluid artifact system used to make leak-free connections between a connection artifact. male and its corresponding female part in medical devices and / or equipment. A Luer-type device according to the present invention can additionally include an integrated septum, through which selective access is provided between two interconnected devices via a Luer-type artifact connection. Non-limiting examples of Luer-type artifacts include the “Luer-Lok,” “Luer-Slip” and “Nexiva Closed IV Catheter” systems produced by Becton Dickenson, Inc.
    [0003] [003] Infusion therapy involves administering a fluid to a patient through a needle or catheter. It is usually prescribed when a patient under treatment cannot be treated effectively by oral medication. Typically, “infusion therapy” refers to procedures in which a drug or other fluid is administered intravenously. However, the term also refers to situations in which fluids are supplied via other non-oral routes, such as intramuscular injections, subcutaneous injections and epidural routes.
    [0004] [004] Intramuscular and subcutaneous injections install a fluid bolus on the patient's tissue. The bolus is slowly dissipated and is absorbed into the surrounding tissues, thereby administering medication or fluid to the patient over a period of time. The injection process generally requires fixed control of the catheter and needle to ensure proper access while preventing or minimizing injury to the patient. In emergency situations, such as when returning from a moving ambulance, a doctor or other healthcare professional may be unable to insert a catheter into a patient due to the excessive movement of the environment that surrounds the patient. As such, the ambulance is requested to stop to allow the healthcare professional to have a stable environment in which to insert the catheter. This creates inconvenience for the healthcare professional and wastes of available time that may be necessary to save the patient's life. Consequently, there is a need in the art for a device that overcomes the difficulties and deficiencies associated with currently available technologies. The present disclosure discusses such a device. BRIEF SUMMARY OF THE INVENTION
    [0005] [005] The present invention provides a Luer-type fixation device that includes a Luer-type adapter that has a first end that contains a septum and a second end that includes a catheter cap that has a base to form a fixation interface with a patient's body surface. The Luer-type adapter additionally includes a wedge seal interposed between the first and the second ends. The wedge seal is provided to receive a base portion of a catheter that is inserted through the septum and into the wedge seal through a probe portion of a catheter passer. Once seated inside the wedge seal, a fluid impermeable seal is established between the base of the catheter and the wedge seal.
    [0006] [006] Some implementations of the present invention additionally include an insertion body that is selectively coupled to the Luer-type adapter. The insertion body slidably houses a catheter passer that includes a probe for contacting and advancing a catheter through the septum to seat a base portion of the catheter in the wedge seal.
    [0007] [007] The catheter passer additionally includes a needle adapter slidably housed inside the catheter passer. The needle adapter includes a needle that has a sharp tip that extends through the probe and catheter in such a way that the sharp tip is exposed distally in addition to a tip of the catheter to assist in inserting the catheter into a patient. In some cases, a distal spring is interposed between the catheter passer and the insertion body to provide a proximal compression force between the two components. The Luer fixation device additionally includes a proximal spring interposed between the catheter passer and the needle adapter to provide distal compression force between the two components.
    [0008] [008] After inserting the catheter in the patient, the proximal spring retracts the catheter adapter in a proximal direction thereby removing and shielding the sharp tip of the needle within at least one of the insertion body and the portion of catheter passer probe. The insertion body is then removed from the Luer adapter and discarded. The Luer-type adapter remains attached to the patient through an adhesive film. The Luer-type adapter maintains the position of the catheter inside the patient and provides access to the catheter through the male Luer and the septum of the Luer-type adapter. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
    [0009] [009] In order for the features and advantages mentioned above, in addition to others, of the invention to be obtained and readily understood, a more particular description of the invention briefly described above will be produced by reference to its specific modalities, which are illustrated in the attached drawings. The understanding that these drawings reveal only the typical modalities of the invention and should not, therefore, be considered as limiting its scope, the invention will be described and explained with specificity and additional details through the use of the attached drawings, in which:
    [0010] [010] Figure 1 illustrates a perspective view of a Luer type fixation device according to a representative embodiment of the present invention.
    [0011] [011] Figure 2 illustrates a cross-sectional view of a Luer type fixation device according to a representative embodiment of the present invention.
    [0012] [012] Figure 3 illustrates an exploded cross-sectional view of a Luer type fixation device according to a representative embodiment of the present invention.
    [0013] [013] Figure 4A illustrates a cross-sectional top view of a Luer type fixation device that has a catheter passer in a first position and a needle adapter in a first needle position according to a representative embodiment of present invention.
    [0014] [014] Figure 4B illustrates a cross-sectional top view of a Luer type fixation device that has a catheter passer that is displaced from a first position and moves towards a second position, where the device has additionally a needle adapter in a first needle position according to a representative embodiment of the present invention.
    [0015] [015] Figure 4C illustrates a cross-sectional top view of a Luer type fixation device that has a catheter passer positioned between a first position and a second position, in which the device additionally has a needle adapter in contact with a boss of the insertion body according to a representative embodiment of the present invention.
    [0016] [016] Figure 4D illustrates a cross-sectional top view of a Luer type fixation device that has a catheter passer positioned between a first position and a second position, in which the device additionally has a needle adapter in one second needle position according to a representative embodiment of the present invention.
    [0017] [017] Figure 4E illustrates a cross-sectional top view of a Luer type fixation device that has a catheter passer positioned in a second position, in which the device additionally has a needle adapter positioned between a second position of needle and a third needle position according to a representative embodiment of the present invention.
    [0018] [018] Figure 4F illustrates a cross-sectional top view of a Luer type fixation device that has a catheter passer in a second position, in which the device additionally has a needle adapter positioned between a second needle position. and a third needle position according to a representative embodiment of the present invention.
    [0019] [019] Figure 4G illustrates a cross-sectional top view of a Luer type fixation device that has a catheter passer in a second position, in which the device additionally has a needle adapter positioned between a second needle position and a third needle position according to a representative embodiment of the present invention.
    [0020] [020] Figure 4H illustrates a cross-sectional top view of a Luer type fixation device that has a catheter passer and a second position, in which the device additionally has a needle adapter positioned between a second needle position. and a third needle position according to a representative embodiment of the present invention.
    [0021] [021] Figure 4I illustrates a cross-sectional top view of a Luer type fixation device that has a catheter passer positioned inside a device insertion body, in which the device additionally has a needle adapter positioned in a third needle position according to a representative embodiment of the present invention.
    [0022] [022] Figure 5 illustrates a cross-sectional view of a Luer-type adapter according to a representative embodiment of the present invention.
    [0023] [023] Figure 6 illustrates a cross-sectional view of a Luer-type adapter and catheter inserted into a patient according to a representative embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION
    [0024] [024] The presently preferred embodiments of the described invention will be better understood with reference to the Figures, in which similar parts are projected by similar numbers throughout the document. It will be readily understood that the components of the present invention, as generally described and illustrated in the accompanying Figures, could be arranged and designed in a wide variety of different configurations. Accordingly, the following more detailed description of some embodiments of the invention, as shown in the Figures, is not intended to limit the scope of the invention as claimed, but is merely representative of some presently preferred embodiments of the invention.
    [0025] [025] In general, the present invention relates to an integrated unit for attaching a catheter and a Luer type access device to a patient. In particular, some embodiments of the present invention provide a portable device that includes an applicator or catheter insertion element that is selectively coupled to a Luer-type adapter. In some cases, the Luer-type adapter comprises a cap made of a flexible polymer material that comprises a base configured to form an interface with a patient's body surface. In some embodiments, the base of the Luer-type adapter additionally comprises an adhesive to secure and secure the location of the Luer-type adapter to the patient. Non-limiting examples of a compatible Luer adapter are provided in Patent Application under serial number US13 / 614.481, entitled LUER SECUREMENT DEVICE, filed on September 13, 2012 by Stephen Bornhoft, which is incorporated into the present invention by way of reference in its entirety.
    [0026] [026] The catheter insertion element is removably coupled to the Luer-type adapter. Thus, after inserting the catheter in the patient, the catheter insertion element is selectively removed from the Luer adapter and discarded. The Luer-type adapter remains in place, thereby allowing the fluid to access the patient.
    [0027] [027] The embodiments of the present invention additionally include a catheter. The catheter of the present invention can include any type or style of catheter compatible with in vitro use. For example, in some cases, the present invention includes a subcutaneous or intramuscular catheter. Consequently, catheters compatible with the present invention can include flexible polymer catheters and / or rigid metallic or polymeric catheters.
    [0028] [028] The applicator or catheter insertion element comprises several components to facilitate patient catheterization. In particular, the catheter insertion element comprises a catheter passer that is slidably housed within the catheter insertion element and that includes a probe configured to advance a catheter through a septum of the Luer-type device and into a patient. The catheter passer additionally includes an inserting needle or needle adapter that is slidably housed inside the catheter passer and that includes a needle that extends through the catheter passer probe and through the cannula to assist insertion of the catheter in a patient. Once the catheter is inserted into the patient, the position of the catheter passer inside the catheter insertion element is retracted, thereby removing the needle from the catheter and shielding a sharp tip of the needle inside the catheter insertion element. catheter.
    [0029] [029] The interconnected relationship between the Luer-type adapter and the catheter insertion element provides a bridge connection between the catheter and the patient's surface. In particular, the Luer-type adapter cover provides a stable and constant connection between the patient and the catheter, thereby allowing the catheterization of a patient in surrounding environments or unstable conditions. In other words, the Luer-type adapter cover provides a constant connection between the Luer-type fixture and the patient's surface, such that a distance between the user's hand and the patient remains constant during catheterization. To provide a better understanding of the Luer type fixture, the various integrated components of the device are described in more detail below.
    [0030] [030] Now with reference to Figure 1, a perspective view of a mounted Luer type fixture 10 is shown. In general, the Luer type 10 fixing device comprises an applicator or insertion body 20 which is selectively coupled to an adapter of the Luer type 70. The insertion body 20 comprises a hollow housing in which a slide passer is slidably housed. catheter 50. The catheter passer 50 is slidably repositioned inside the insertion body 20 by the user to advance a catheter and the needle through the Luer type adapter 70 and on a patient. After catheterization, the needle is automatically retracted from the patient and the Luer 70 adapter in such a way that a sharp tip of the needle is shielded within at least one of the insertion body 20 and the catheter passer 50. The body insert 20 is then separated from the Luer 70 adapter and discarded. The Luer 70 adapter remains attached to the patient to provide access to the patient through the inserted catheter.
    [0031] [031] More specifically, in some embodiments, the Luer type 10 fixture comprises an applicator or insertion body 20 that has a proximal end 22 and a distal end 24. The insertion body 20 additionally comprises a hollow interior space in the which a catheter passer 50 is slidably housed. The insertion body 20 additionally comprises an access window 26 which is generally located at the proximal end 22, and which provides access for the user to the catheter passer 50. The catheter passer 50 further comprises a feature 52 which is configured to receive or accommodate a thumb or other finger from a user to slidably reposition the catheter passer 50 within the insertion body 20. For example, in some embodiments, the feature 52 comprises an opening that is large enough to accommodate a user's thumb.
    [0032] [032] In some embodiments, the length of the access window 26 is determined and selected based on a desired or allowed path length for the catheter passer 50 inside the insertion body 20. Thus, the distal and proximal limits the access window 26 dictates the maximum proximal and distal positions of the catheter passer 50 inside the insertion body 20.
    [0033] [033] The insertion body 20 further comprises distal side handles 28 which are provided to assist the user in grasping the distal end 24 of the insertion body 20 between two adjacent fingers, for example, between the middle fingers and the index of the hand. In this way, the side handles 28 provide opposite surfaces that are configured to accommodate the handle of the Luer type 10 fixture and provide opposite surfaces against which the user's adjacent fingers can pull to facilitate the user in sliding the catheter passer 50 into the insertion body 20 through the user's thumb inserted into opening 52. Consequently, some embodiments of the present invention allow a user to hold and use the Luer type 10 fixture in a door handle configuration, in which a The distal end of the device 10 is held between the user's adjacent fingers with the user being positioned in the opening 52. In some embodiments, the side handles 28 additionally comprise a flexible or moldable material that conforms to support the user's grip. In other embodiments, the side handles 28 comprise lateral extensions of the insertion body 20 which provide handle surfaces that are perpendicular to the insertion body 20.
    [0034] [034] The Luer type 10 fixture additionally comprises a Luer type 70 adapter which is selectively coupled to a distal end 24 of the insertion body 20. The Luer type 70 adapter includes a cover 72 comprising a polymeric material, elastomeric and flexible. The cap 72 further comprises a base 74 which is configured to interface with a patient's body surface. In some embodiments, the base 74 additionally comprises an adhesive through which the position of the Luer 70 type adapter is attached and fixed on the patient.
    [0035] [035] In some embodiments, the Luer-type adapter 70 is threadably coupled to the distal end 24 of the insertion body 20. For example, in some embodiments, the distal end 24 of the insertion body 20 additionally comprises a set of threads females configured to threadably receive a set of male disks from the Luer 70 adapter. In this way, a user can selectively remove the insert body 20 of the Luer 70 adapter by unscrewing the two components.
    [0036] [036] Now referring to Figure 2, a cross-sectional view of the Luer type 10 fixation device is shown before catheterization. In some embodiments, the Luer-type adapter 70 comprises a male Luer 76 in which a septum 80 is housed. The septum 80 additionally comprises a slot or other pathway through which a catheter 90 can be inserted. In some embodiments, the gap or path is preformed. In other embodiments, the slit or pathway is formed by advancing the catheter 90 through the septum 80.
    [0037] [037] A distal end of the male Luer 76 further comprises a cap adapter 78 which has a distal channel on which a proximal end of the cap 72 is seated. The cap adapter 78 additionally includes a proximal end that forms an interface with septum 80. In some embodiments, the proximal end of the cap adapter 78 seals or otherwise captures a distal end of the septum 80 between the cap adapter 78 and an internal surface of the male Luer 76.
    [0038] [038] The cap adapter 78 additionally comprises an intermediate channel on which a wedge seal 82 is seated. The wedge seal 82 generally comprises a polymeric material capable of forming a fluid impermeable seal between the cap adapter 78 and a base portion 92 of catheter 90.
    [0039] [039] As previously discussed, the Luer 70 adapter is threadably coupled to the distal end 24 of the insertion body 20. In some embodiments, the distal end 24 comprises a nozzle that has an internal surface that includes a threaded surface for to threadably receive the threaded surface of the male Luer 76. The distal end 24 additionally comprises a distal opening 30 which is dimensioned and configured to allow the passage of catheter 90 and probe 53 of catheter passer 50.
    [0040] [040] The catheter passer 50 is slidably housed within the interior space 32 of the insertion body 20. In some embodiments, the catheter passer 50 comprises an alignment channel 54 which is configured to receive and travel along an inner ridge 34 of the insertion body 20 in the proximal and distal directions 12 and 14, respectively. In some cases, the catheter passer 50 comprises a plurality of alignment channels 54 which is provided to maintain the proper alignment and position of the catheter passer 50 within the inner space 32 of the insertion body 20.
    [0041] [041] The catheter passer 50 further comprises a probe 53 which extends distally from the distal end 56. The probe 53 is dimensioned and configured to form an interface with the base portion 92 of the catheter 90. For example, in some embodiments , the outer diameter of probe 53 is approximately equal to the outer diameter of base portion 92 of catheter 90. As such, probe 53 is capable of advancing base portion 92 of catheter 90 through distal opening 30 and through septum 80 to settle the base portion 92 on the wedge seal 82 of the cap adapter 78.
    [0042] [042] The distal end 56 additionally comprises a distal protuberance 58 on which a distal spring 60 is seated. The distal spring 60 provides compressive force between the catheter passer 50 and the insertion body 20 as the catheter passer 50 is. slid in the distal direction 14. As such, the distal spring 60 assists the user in sliding the catheter dowel 50 in the proximal direction 12.
    [0043] [043] The distal end 56 further comprises a proximal protuberance 62 on which a proximal spring 64 is seated. The proximal spring 64 provides compressive force between the catheter passer 50 and the needle adapter 100 when the needle adapter 100 is in a first position or distal needle position, as shown. In some embodiments, an internal surface of the catheter passer 50 further comprises a stop feature 66 that maintains the first needle position of the needle adapter 100 during the catheterization process. The first needle position is defined as the position of the needle adapter 100 within catheter passer 50 where the sharp tip 104 of needle 102 extends distally beyond tip 94 of catheter 90.
    [0044] [044] When engaged by the stop feature 66, the needle adapter 100 travels with the catheter dowel 50 as the catheter dowel 50 is slid in the distal direction 14. A yaw force between the needle adapter 100 and the dowel feature stop 66 is selected as being greater than the compression force of the proximal spring 64 when the needle adapter 100 is in the first needle position, thereby maintaining the first needle position of the needle adapter 100. An element versed in The skilled artisan will note that the stop feature 66 can include any mechanical feature that maintains the first needle position of the needle adapter 100 with a force greater than the compression force of the proximal spring 64.
    [0045] [045] In some embodiments, the interior space 32 additionally comprises a rigid boss 36 which is positioned and configured to pass through the alignment channel 54 and to contact the needle adapter 100 as the catheter passer 50 is slid in the direction distal 14. Through contact between boss 36 and needle adapter 100, the compression force between boss 36 and needle adapter 100 increases as the catheter passer continues to slide in the distal direction 14. At the point where the compression force between boss 36 and needle adapter 100 exceeds the yaw force between stop feature 66 and needle adapter 100, needle adapter 100 deflects stop feature 66 in the proximal direction 12. Once the needle adapter 100 deflects the stop feature 66, the proximal spring compression force 64 pushes the needle adapter 100 in the proximal direction 12 thereby removing needle 102 from catheter 90 and through the septum 80.
    [0046] [046] Referring generally to Figures 3 to 4I, a cross-sectional view of the Luer type 10 fixture is shown in various stages of activation or use. For example, Figure 4A shows the Luer 10 fixture prior to activation, while Figure 4I shows the Luer 10 fixture after use. Consequently, the insertion process is shown sequentially from Figure 4A to Figure 4I, in which the structural features of each component are clearly shown and isolated in Figure 3.
    [0047] [047] The length of the access window 26 is selected to limit the movement of the catheter passer 50 between a first position and a second position. The first position is characterized by the opening 52 of the catheter passer 50 which is aligned with the proximal end 38 of the access window 26, as shown in Figure 4A. The second position is characterized by the opening 52 which is aligned with the distal end 40 of the access window 26, as shown in Figure 4E.
    [0048] [048] In continuous reference to Figure 4A, the first position is additionally characterized by the position of the sharp tip 104 of the needle 102 in relation to the tip 94 of the catheter 90 and the septum 80. In particular, in the first position the sharp point 104 extends distally in addition to tip 94 and is positioned distally to septum 80. As such, sharp tip 104 and catheter 90 can be inserted into the patient without causing damage to septum 80, since sharp point 104 is required to pass through the septum 80 during catheterization. Consequently, the placement of the proximal end 38 of the access window 26 is selected to position the interface between probe 53 and base portion 92 of catheter 90 such that tip 94 of catheter 90 extends through septum 80.
    [0049] [049] Similarly, the second position is characterized by the position of the base portion 92 of catheter 90 in relation to the wedge seal 82, as shown in Figure 4E. In particular, in the second position, the base portion 92 is completely seated on the wedge seal 82. In this way, the placement of the distal end 40 of the access window 26 is selected to limit the distal sliding of the catheter passer 50 in such a way that the base portion 92 of the catheter 90 is fully seated on the wedge seal 82.
    [0050] [050] Referring to Figures 4B and 4C, as the catheter passer 50 is slid in the distal direction 14, the boss 36 comes into contact with the needle adapter 100 thereby stopping the distal movement of the needle adapter 100 and, consequently, stopping the distal movement of the sharp tip 104 of the needle 102 resulting in the configuration shown in Figure 4C. Consequently, the position of the boss 36 is selected to limit the distal movement of the needle adapter 100. In particular, the position of the boss 36 is selected to stop the distal movement of the needle adapter 100 after insertion of the sharp tip 104 in the patient. Once stopped, catheter passer 50 is allowed to continue to slide distally, thereby advancing the tip of catheter 94 on the patient while the sharp tip 104 remains stationary, as shown in Figures 4D and 4E. By sliding or further advancing the catheter passer 50 in the distal direction 14, the tip of the catheter 94 advances in the distal direction 14 thereby removing or shielding the sharp tip 104 inside the catheter 90. Thus, the boss 36 is positioned to limit or stop the distal movement of the needle adapter 100 before the catheter passer 50 fully reaches the second position.
    [0051] [051] As previously discussed, the stops feature 66 temporarily interlocks catheter adapter 100 and catheter dowel 50. Thus, when catheter dowel 50 is in first position, needle adapter 100 is in first position needle, as shown in Figures 4A to 4C. The first needle position is characterized by the position of the sharp tip 104 in relation to the tip of catheter 94. In particular, the first needle position is characterized by the sharp tip 104 of needle 102 that extends distally beyond the tip of catheter 94. Thus, the first needle position ensures that the sharp tip 104 is exposed to assist in providing access to the catheter 90 for the patient.
    [0052] [052] As catheter passer 50 moves distally from the first position towards the second position, the needle adapter 100 remains in the first needle position until the rigid boss 36 contacts the needle adapter 100, shown in Figures 4D to 4G. When this contact occurs, probe 53 continues to advance catheter 90 distally, thereby removing sharp point 104 in catheter 90, as shown in Figures 4D to 4G. Consequently, a second needle position is characterized by the contact between the rigid boss 36 and the needle adapter 100, in which the sharp tip 104 is removed proximally in the catheter 90.
    [0053] [053] Since the needle adapter 100 deflects the stop resources 66, the needle adapter 100 is oriented proximally through the proximal spring 64, thereby causing the needle adapter 100 to travel from the second position needle to a third needle position, as shown in Figures 4E to 4H. The third needle position is characterized by the position of the sharp point 104 in relation to the distal end 24 of the insertion body 20. In particular, the third needle position results in the positioning of the sharp point 104 within the interior space 32 of the insertion body 20, as shown in Figure 4I. Alternatively, in some embodiments, the third needle position results in the sharp tip 104 being positioned inside probe 53 of catheter passer 50.
    [0054] [054] Referring to Figures 4E to 4H, as needle 102 is withdrawn or retracted in the proximal direction 12, the outer surface of needle 102 is cleaned by passing through septum 80. As such, blood or other fluid in the needle 102 is removed before being shielded inside the insertion body 20. In some embodiments, the drag force of the slit 88 of the septum 80 on the outer surface of the needle 102 is greater than the compression force of the proximal spring 64. As such, the position of the needle adapter 100 remains stationary against the boss 36 until the insertion body 20 is disconnected from the Luer type adapter 70 and moved in the proximal direction 12. As the insertion body 20 is moved in the proximal direction 12, the needle 102 is extracted through the slit 88 of the septum 80, thereby cleaning the outer surface of the needle 102. When the sharp point 104 crosses the slit 88, the compressive force of the proximal spring 64 is released by quickly withdrawing, the tip sharp 104 on probe 53 of catheter passer 50, as shown in Figure 4I.
    [0055] [055] In some embodiments, the catheter drawer 50 additionally comprises one or more proximal stopping features 68. The proximal stopping features 68 are provided to limit the proximal movement of the needle adapter 100 within the catheter drawer 50. Consequently , in some embodiments, the third needle position is defined by the contact between the needle adapter 100 and the proximal stopping features 68, in which the third needle position shields the sharp point 104 within at least one of the body of insert 20 and catheter passer 50, as shown in Figure 4I. Thus, as the needle adapter 100 is slid proximally 12 by the proximal spring 64, the needle adapter 100 is to prevent the catheter passer 50 from exiting through the contact of the proximal stopping features 68.
    [0056] [056] Now referring to Figure 5, a cross-sectional side view of the Luer 70 adapter is shown. In some embodiments, the base 74 of the cap 72 is angled to facilitate insertion of the catheter 90 into the patient. The angle of the base 74 can be selected based on an ideal insertion angle for the catheter 90. For example, in some embodiments, the base 74 of the cap 72 comprises an angle θ of approximately 30 and 45 °. In other embodiments, the angle θ comprises approximately 90 °.
    [0057] [057] As previously discussed, in some embodiments, the base 74 additionally comprises an adhesive layer or film 84 that surrounds the distal end of the cover 72. The adhesive film 84 is applied to a patient's body surface to secure and maintain the position of the Luer 70 adapter on the patient. In some embodiments, the adhesive film 84 further comprises an external non-adhesive cover (not shown) that is removed by a user to expose the adhesive film 84 prior to the application of the Luer-type adapter 70 on the patient's body. The adhesive film 84 additionally comprises an insertion target 86 in concentric alignment with the wedge seal 82 and the slit 88 of the septum 80. Thus, as the catheter 90 and the needle 102 are advanced through the septum 80 and the cap 72, the tip portion 94 and the sharp tip 104 pass through the adhesive film 84 to contact the patient. In some embodiments, the insertion target 86 further comprises a contrast color that serves as a visual marker for aligning the insertion target 86 with an anatomical characteristic of the patient. For example, in some cases, insertion target 86 is visually aligned to prevent perforation of a vein.
    [0058] [058] Adhesive film 84 and cap 72 additionally provide a blood barrier between patient 110 and an outdoor environment 120, as shown in Figure 6. For example, during catheterization, blood may leak or leak from the insertion site 112 through the adhesive film 84. The involved nature of the cap 72 and the adhesive film 84 captures any blood or other fluids thereby preventing undesirable exposure to the user. The wedge seal 82 additionally provides a fluid impermeable seal between the base portion 92 of the catheter 90 and the cap adapter 78 thereby preventing blood from diverting from the male Luer 76. Consequently, once inserted into a patient 110 , the Luer 70 adapter provides a closed fluid impermeable system that is selectively accessible through slit 88 of septum 80.
    [0059] [059] The present invention can be incorporated in other specific ways without departing from its structures, methods or other essential features as widely described in the present invention and claimed hereinafter. All the modalities and examples described should be considered in any and all aspects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that fall within the meaning and equivalence range of the claims must be covered in their scope.
    权利要求:
    Claims (9)
    [0001]
    Fixing device (10) CHARACTERIZED by the fact that it comprises: a Luer-type adapter (70) having a first end comprising a septum (80) and a second end comprising a catheter cap (72) having a base (74), the Luer-type adapter (70) comprises additionally a wedge seal (82) interposed between the first and second ends; an insertion body (20) having a distal end (24) for receiving the first end of the Luer-type adapter (70); a catheter (90) comprising a base portion (92); a catheter passer (50) slidably housed inside the insertion body (20), the catheter passer (50) having a probe (53) to contact the base portion (92) of the catheter (90) , the probe (53) being configured to advance the base portion (92) of the catheter (90) through the septum (80) of the Luer-type adapter (70) and into the wedge seal (82), the seal in wedge (82) being configured to retain the base portion (92) of the catheter and form a fluid impermeable seal (82) between the base portion (92) and the wedge seal (82), the probe (53) additionally having a opening that provides a path through the probe (53); a needle adapter (100) slidably housed inside the catheter passer (50) and which includes a needle (102) that extends through the opening of the probe (53) and the catheter (90) to assist in the insertion of the catheter (90) in a patient; and a distal spring (60) interposed between an external surface of the catheter passer (50) and an internal surface of the insertion body (20) and a proximal spring (64) interposed between an internal surface of the catheter passer (50) and the needle adapter (100).
    [0002]
    Device according to claim 1, CHARACTERIZED by the fact that a proximal end of the catheter passer (50) additionally comprises an opening (52) into which the user's thumb can be inserted to slide the catheter passer (50) into the inside the insertion body (20).
    [0003]
    Device according to claim 2, CHARACTERIZED by the fact that the insertion body (20) additionally comprises an access window (26) to allow a user to access the opening of the catheter passer (50), the access window (26) having a longitudinal length greater than the opening (52) of the catheter passer (50).
    [0004]
    Device according to claim 1, CHARACTERIZED by the fact that the catheter passer (50) is slidably movable inside the insertion body (20) from a first position to a second position, where, when in the first position, the probe (53) and the base portion (92) of the catheter (90) are positioned inside the insertion body (20), and when in the second position, the probe (53) is at least partially positioned inside the septum (80) of the adapter (70), and the base portion (92) of the catheter (90) is seated inside the wedge seal (82).
    [0005]
    Device according to claim 4, CHARACTERIZED by the fact that the needle adapter (100) is slidably movable inside the catheter passer (50) from a first needle position, to a second needle position , for a third needle position, where, when in the first needle position, a sharp tip (104) of the needle extends distally beyond a tip (94) of the catheter (90), and, when in the second needle position , the sharp tip (104) of the needle (102) is withdrawn into the tip (94) of the catheter (90), and, when in the third needle position, the sharp tip (104) of the needle (102) is removed entirely of the catheter (90) and positioned inside at least the catheter passer (50) and the insertion body (20).
    [0006]
    Device according to claim 5, CHARACTERIZED by the fact that the needle adapter (100) is in the first needle position as the catheter dowel (50) moves from the first position to the second position, the needle (100) is in the second needle position when the catheter dowel (50) is in the second position, and the needle adapter (100) moves from the second needle position to the third needle position according to the needle dowel. catheter (50) moves from the second position to the first position.
    [0007]
    Device according to claim 1, CHARACTERIZED by the fact that the base (74) additionally comprises an external adhesive layer (84) that surrounds the distal end of the cover (72).
    [0008]
    Device according to claim 7, CHARACTERIZED by the fact that the external adhesive layer (84) additionally comprises an insertion target (86) in concentric alignment with a path through the septum (80) and the opening of the probe (53) .
    [0009]
    Device according to claim 8, CHARACTERIZED by the fact that the sharp tip (104) of the needle (102) and the tip (94) of the catheter (90) pass through the adhesive layer (84) as the passer of catheter (50) is moved from the first position to the second position.
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    同族专利:
    公开号 | 公开日
    AU2013315695A1|2015-04-09|
    BR112015005651A2|2017-07-04|
    CN203647840U|2014-06-18|
    JP2015528378A|2015-09-28|
    AU2013315695B2|2017-06-15|
    EP2895231A1|2015-07-22|
    CA2884768C|2019-12-17|
    WO2014043123A1|2014-03-20|
    CA2884768A1|2014-03-20|
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    MX2015003334A|2015-06-05|
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    US8915891B2|2014-12-23|
    JP6262741B2|2018-01-17|
    MX355991B|2018-05-08|
    US20140074031A1|2014-03-13|
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    法律状态:
    2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-11-12| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2021-01-26| B09A| Decision: intention to grant|
    2021-02-17| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/09/2013, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US13/615,201|2012-09-13|
    US13/615,201|US8915891B2|2012-09-13|2012-09-13|Integrated catheter securement and luer access device|
    PCT/US2013/059052|WO2014043123A1|2012-09-13|2013-09-10|Integrated catheter securement and luer access device|
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