![]() CATHETER FIXING DEVICE AND METHOD FOR MANUFACTURING THE SAME
专利摘要:
luer clamping device. a luer attachment device (10) comprising a flexible shield (12) that is configured to attach to a patient's surface, the flexible shield additionally having a luer adapter (20) for receiving a catheter insert and/or a line of fluid. the luer attachment device further includes a wedge seal (50) which is positioned within the luer adapter and is configured to receive a base portion of a catheter during a catheterization procedure. once the base of the catheter is seated within the wedge seal, an adequate depth of insertion of the catheter into the patient is achieved. the interaction between the wedge seal and the base of the catheter prevents fluid leakage between the catheter and the luer adapter. a fluid can be delivered to the patient by attaching a fluid delivery device to the luer adapter portion of the luer attachment device following catheterization. 公开号:BR112015005642B1 申请号:R112015005642-3 申请日:2013-09-10 公开日:2021-08-17 发明作者:Stephen Bornhoft 申请人:Becton, Dickinson And Company; IPC主号:
专利说明:
FUNDAMENTALS OF THE INVENTION [001] This description generally refers to Luer catheters and devices. More specifically, this description discusses a Luer fixation device comprising a flexible shield coupled to a Luer adapter having a wedge-type seal disposed therein, where the flexible shield is attached to a patient and a catheter is simultaneously inserted into the patient and seated inside the wedge seal during a catheterization procedure. [002] As used herein, the term "Luer" is understood to describe and include any Luer taper or other small-scale fluid fitting system for making leak-free connections between a male taper fitting and its mating female part on medical devices or equipment. A Luer device in accordance with the present invention may additionally include an integrated membrane, where selective access is provided between two interconnected devices via a Luer fitting connection. Non-limiting examples of Luer accessories include "Luer-Lok", "Luer-Slip" and "Nexiva Closed IV Catheter" systems produced by Becton Dickinson, Inc. [003] Infusion therapy involves administering a fluid to a patient through a needle or catheter. It is usually prescribed when the patient's treatment cannot be efficiently carried out by oral medication. Typically, "infusion therapy" refers to procedures where a drug or other fluid is administered intravenously. However, the term also refers to situations in which fluids are delivered through other non-oral routes, such as intramuscular injections, subcutaneous injections, and epidural routes. [004] Infusion therapies are generally used to introduce or remove fluid from a patient. The infusion process generally requires stable control of the catheter and needle to ensure adequate access while avoiding or minimizing patient injury. In emergency situations, such as in a moving ambulance, a physician or other healthcare professional may be unable to insert a catheter into a patient due to excessive movement in the patient's surroundings. As such, the ambulance needs to stop to allow the healthcare professional to have a stable environment in which to insert the catheter. This creates an inconvenience for the healthcare professional and wastes valuable time that may be needed to save the patient's life. Accordingly, there is a need in the art for a device that overcomes the difficulties and disadvantages associated with currently available technologies. The present description describes such a device. [005] EP1776980 discloses a catheter fixation device as defined in the preamble of claim 1. BRIEF SUMMARY OF THE INVENTION [006] The present invention provides a Luer attachment device that includes a flexible shield having a base configured to attach to a surface of a patient, thus forming a secure interface with the patient. Flexible shield is attached to a Luer adapter. The Luer Adapter includes a wedge seal disposed on an inner surface of the Luer Adapter. The Luer fitting further includes a membrane disposed within the Luer fitting, an internal lumen being formed between the wedge seal and the membrane. [007] In some cases, the Luer fixation device further comprises a shield adapter having a distal end coupled to a proximal end of the flexible shield, the shield adapter additionally having a proximal end coupled to the Luer adapter. The base of the flexible shield can additionally include an adhesive film that isolates an indoor environment from the flexible shield from the external environment. [008] The wedge-type seal generally comprises an annular seal having an inside diameter configured to receive a base portion of a catheter. The base portion of the catheter is seated in the wedge seal as part of a catheterization process. In some implementations, the inner diameter of the wedge seal receives the outer surface of the base of the catheter to form the fluid impermeable seal. [009] The Luer adapter portion of the Luer fixture further comprises a set of threads for compliantly receiving a catheter insertion element. A catheter inserter can include any device or combination of devices that delivers and inserts a catheter into the Luer fixture as part of a catheterization process. For example, a catheter inserter may include a probe that contacts the base portion of the catheter to advance the catheter through the membrane of the Luer adapter and into the patient such that the base portion of the catheter be seated inside the wedge seal. [010] In some implementations, the base of the flexible shield is angled with respect to a sidewall of the flexible shield to facilitate insertion of the catheter at a desired angle. For example, in some cases, the base is angled from approximately 30 to approximately 90. [011] The present invention further includes one or more methods of manufacturing a Luer fixture. In some implementations, a method of manufacturing a Luer fixation device includes the steps to (1) provide a flexible shield having a base configured to attach to a patient's surface; (2) attach the flexible shield to a Luer adapter; (3) insert a wedge seal into an inner surface of the Luer adapter; and (4) disposing a membrane with the Luer adapter. The method of the present invention may further include the steps of providing a shield adapter, where the shield adapter is coupled to a proximal end of the flexible shield and a distal end of the Luer adapter. A step can additionally be provided to attach an adhesive film to the base of the flexible shield, where the adhesive film encloses an internal environment of the flexible shield. [012] Some implementations of the present invention further include a Luer fixture having a flexible shield having a base configured to fix to a surface of a patient; an adhesive film fixed to the base and enclosing an internal environment of flexible protection; a Luer adapter coupled to the flexible shield, an inner surface of the Luer adapter comprising an annular wedge-type seal; a membrane disposed within the Luer adapter; and an insertion target formed in the adhesive film and in concentric alignment with the membrane and the annular wedge-type seal. BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS [013] In order that the manner in which the aforementioned and other features and advantages of the invention are obtained and are readily understood, a more particular description of the invention described briefly above will be created by reference to the specific embodiments thereof, which are illustrated in the attached drawings. With the understanding that these drawings present only the typical embodiments of the invention and are therefore not considered to limit its scope, the invention will be described and explained with specificity and additional details through the use of the attached drawings in which: [014] Figure 1 illustrates a side perspective view of a Luer fixation device coupled to the surface of a patient according to a representative embodiment of the present invention [015] Figure 2 illustrates a cross-sectional view of a Luer fixture of Figure 1 according to a representative embodiment of the present invention; [016] Figure 3, illustrated by parts A and B, illustrates a cross-sectional view of a Luer fixation device before receiving a catheter according to a representative embodiment of the present invention; [017] Figure 4, illustrated by parts A to D, illustrates a cross-sectional view of a Luer fixation device in various positions during a catheterization process according to a representative embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION [018] The currently preferred embodiments of the described invention will be better understood by reference to the figures, where similar parts are designated by similar numerical references. It will be readily understood that components of the present invention, as generally described and illustrated in the accompanying figures, can be arranged and designed in a wide variety of different configurations. Thus, the more detailed description below of some embodiments of the invention as represented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of some currently preferred embodiments of the invention. [019] Generally, the present invention relates to an integrated Luer fixation device for securing a catheter and a Luer access port or coupler to a patient. In particular, some embodiments of the present invention provide a Luer fixation device that is attached to a patient and subsequently receives a catheter that is inserted into the patient. The process of coupling the catheter to the Luer fixation device provides an integrated unit that secures and maintains the position of the catheter within the patient. Additionally, the integrated device protects the catheter insertion site, thus preventing infection and unwanted exposure of blood to a healthcare professional. [020] In some cases, the Luer fixation device comprises a shield made of a flexible polymeric material comprising a base configured to interface with a patient's body surface. In some embodiments, the base of the Luer adapter additionally comprises an adhesive to secure and secure the location of the Luer fixture on the patient. The Luer fixation device further comprises a Luer adapter to which a catheter inserter is temporarily coupled. The catheter insertion element is configured to advance a catheter through the Luer fixture and into the patient. After insertion is completed into the patient, a base portion of the catheter is seated within a wedge-like seal of the Luer fixture, thus providing the integrated device. The wedge seal provides a fluid-tight seal between the base of the catheter and the Luer adapter, thereby isolating the area surrounding the insertion site from an outside environment. Following insertion of the catheter into the patient, the catheter insertion element is selectively removed from the Luer adapter and discarded. The Luer adapter remains in place thus allowing fluid access to the patient. [021] 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 an intravascular catheter, or a subcutaneous or intramuscular catheter. Accordingly, catheters compatible with the present invention may include flexible polymeric catheters and/or rigid metallic or polymeric catheters. [022] The catheter insertion element may include any device or combination of devices to facilitate simultaneous patient catheterization and placement of the catheter base within the wedge seal of the Luer fixture. Non-limiting examples of compatible catheter inserts are set forth in US patent application No. 13/615,201 entitled INTEGRATED CATHETER SECUREMENT AND LUER ACCESS DEVICE, filed September 13, 2012 by Stephen Bornhoft, and US patent application No. 13/615,012, entitled INTRAVENOUS CATHETER INSERTER, filed September 13, 2012 by Stephen Bornhoft, each of which is incorporated herein in its entirety. In some cases, a catheter insert comprises a probe configured to advance a catheter through a membrane of the Luer fixture and into a patient. The catheter insertion element includes a needle that extends through the probe of the catheter insertion element and through the catheter to aid insertion of the catheter into a patient. Once the catheter is inserted into the patient, the catheter insert and needle are retracted, and the inserted catheter is removed from the Luer fixture. [023] The interconnected relationship between the Luer fixture and the catheter insertion element provides a bridging connection between the catheter and the patient's surface. In particular, the protection of the Luer Fixation Device provides a constant and stable connection between the patient and the catheter, thus allowing a patient to be catheterized under stable conditions. In other words, the Luer adapter shield provides a constant connection between the Luer fixation device and the patient's surface so that a distance between the user's hand and the patient remains constant during catheterization. To provide a better understanding of the Luer fixture, the various integrated components of the fixture are described in more detail below. [024] Referring now to Figure 1, a perspective view of an assembled Luer fixture 10 is shown attached to a patient 100. In general, the Luer fixture 10 comprises a flexible shield 12 having a base 14 which is coupled to an adhesive layer or film 16. The adhesive film 16 is applied to the patient 100 to secure and retain the position of the Luer fixation device 10 to the patient 100. In some embodiments, the adhesive surface additionally comprises a wrap or protective cover 17 which is removed to expose the adhesive surface prior to application of the Luer fixation device 10 to patient 100 (see figure 3B, for example). [025] The flexible shield 12 is attached to a Luer connector or adapter 20. In some embodiments, the flexible shield 12 is attached to the Luer adapter 20 through a shield adapter 30. For example, in some embodiments a proximal end or upper ferrule portion 18 of flexible shield 12 is inserted into a distal end or annular channel 32 of shield adapter 30. A proximal end of shield adapter 30 is further coupled to a distal end of Luer adapter 20. Luer adapter 20 further comprises a set of threads 32 for receiving a catheter insert and/or a fluid dispensing apparatus, such as a syringe and a fluid line. The Luer fixture 10 further comprises a membrane 40 which is housed within the Luer adapter 20. [026] Referring now to Figure 2, a cross-sectional view of the Luer fixture 10 is illustrated. In some embodiments, membrane 40 is housed within Luer adapter 20 and interlocked between Luer adapter 20 and shield adapter 30. As such, the position of membrane 40 is maintained during use of device 10. Membrane 40 may include additionally a cut 42. The cut 42 may be pre-cut or may be provided by the needle of the catheter inserter during the catheterization process. In some cases, cut 42 is self-sealing. In the closed or sealed position, the membrane 40 and cut 42 prevent fluid communication between the insertion site 86 and the external environment 102, thus preventing exposure of blood to the user, and preserving the sterile environment within the shield. flexible 12. [027] The protective adapter 30 additionally comprises a wedge-type seal 50. The wedge-type seal 50 generally comprises an annular polymeric seal that is seated in a channel or groove 34 formed in an inner surface of the adapter 30. The seal-type 50 wedge 50 further comprises an inside diameter that is configured to compatibly receive and retain a base 92 of catheter 90 in a fluid impermeable manner, as illustrated. [028] In some embodiments, catheter 90 is advanced through cut 42 of membrane 40 and into patient 100 to a depth at which base 92 of catheter 90 is fully seated in wedge seal 50. Accordingly, a depth The desired insertion length of catheter 90 can be selected by increasing or decreasing the length between tip 94 and base 92 of catheter 90. The fully seated position of base 92 within wedge seal 50 provides a fluid impermeable seal that further insulates the insertion location 86 from the external environment 102. Additionally, the fluid-tight seal between the base 92 and the wedge seal 50 prevents fluid leakage between the lumen 36 and the sterile environment within the flexible shield 12. [029] Referring now to Figure 3A, the Luer 10 fixation device is illustrated prior to catheterization. In some embodiments, flexible shield 12 comprises a sidewall 13 and a base 14. In some cases the base 14 of the flexible shield 12 is angled with respect to the sidewall 13 to facilitate insertion of the catheter into the patient at an angle wanted. The angle of base 14 can be selected based on an optimal insertion angle for the catheter. For example, in some embodiments, base 14 of shield 12 comprises an angle θ of approximately 90°, as illustrated in Figure 3B. [030] Adhesive film 16 may additionally include an insert mark or target 19 that is positioned in concentric alignment with the wedge seal 50 and cut 42 of the membrane 40. In some embodiments, the insert target 19 comprises a contrasting color or design that is printed or otherwise provided on film 16. In other embodiments, insertion target 19 comprises a physical hole. Insertion target 19 is useful in precisely positioning the Luer fixation device 10 on the patient to achieve catheterization at a desired location. For example, a healthcare professional can use the insertion target 19 to position the Luer fixation device 10 on a patient so as to avoid puncturing a mole or hitting a nerve or other anatomical feature of the patient with the needle and catheter. Thus, as the catheter and catheter insert needle are advanced through membrane 40 and shield 12, a tip portion of the needle and catheter passes through insertion target 19 and into the desired location of the patient 100. In some embodiments, the flexible nature of shield 12 allows for slight adjustment of the needle and catheter trajectory during the catheterization process. Accordingly, insertion of the needle and catheter is not restricted by insertion target 19. Instead, insertion target 19 can be used as a visual indicator by which to calibrate the approximate location of the catheter. [031] As discussed previously, in some embodiments, the adhesive film 16 additionally comprises a protective layer 17 or backing. The protective layer 17 can include any material that can adhere to and be removed from the adhesive film 16 without compromising adhesive properties. For example, in some embodiments, the protective layer comprises paper having a coating of wax or plastic, as is commonly used in the art. [032] Referring now to Figures 4A to 4D, a cross section of the Luer 10 fixture is illustrated in various positions during a catheterization procedure. As discussed previously, the Luer fixation device 10 is used in combination with a catheter insertion element 120. The catheter insertion element 120 may include any device or combination of devices necessary to deliver and advance catheter 90 through the catheter device. Luer 10 fixation and into a patient. In some embodiments, catheter insertion member 120 is configured to advance catheter 90 to a maximum depth of insertion into the patient, where the maximum depth of insertion results in base portion 92 being fully seated in the wedge seal. 50. In other embodiments, shield adapter 30 comprises a physical feature that prevents excessive insertion of catheter 90 into the patient. [033] Referring to Figure 4A, the Luer fixture 10 is shown threadedly coupled to the catheter inserter 120. In some cases, a catheter inserter 120 is provided having a housing 122 comprising a set of threads for coupling to the Luer fixture 10. Catheter inserter 120 further includes a lumen 124 in which catheter 90 is housed prior to catheterization. A compatible catheter insertion member 120 will additionally include a probe 130 that is configured to advance catheter 90 through lumen 124, through membrane 40 and into the patient to a depth at which the base 92 of catheter 90 is fully seated in wedge seal 50. [034] In some cases, the catheter 90 comprises a rigid material having a sharpened distal end 94. As such, the catheter 90 is capable of being advanced through the Luer fixation device 10 and into the patient by the probe 130 For example, catheter 90 may comprise a rigid or metallic polymeric material having a sharp beveled distal end 94. In other cases, catheter 90 comprises a flexible or semi-flexible material that is incapable of piercing the patient's skin. Accordingly, in some embodiments, a compatible catheter inserter 120 will further comprise a needle 140 that extends through catheter 90 such that a sharp distal tip 144 of needle 140 is exposed in addition to distal tip 94 of catheter 90. During catheterization, sharpened distal tip 144 contacts the patient and provides an opening into which catheter 90 is inserted and advanced. Needle 140 is located within the lumen of catheter 90, thereby providing rigidity to catheter 90 to facilitate insertion of catheter 90 into the patient. [035] In some embodiments, the catheterization process begins when the catheter insertion member 120 is coupled to the Luer 10 fixture. Probe 130 (or an equivalent variation thereof) advances catheter 90 and needle 140 through the membrane 40. In some cases, sharp point 144 of needle 140 pierces membrane 40 to provide a path through membrane 40. In other cases, membrane 40 comprises a self-sealing cut 42 through which sharp point 144 and catheter 90 are advanced. [036] After further advancement, the sharp point 144 pierces the adhesive film 16 approximately into the insertion target 19, as illustrated in Figure 4B. Needle tip 144 and catheter tip 94 are advanced through the opening in adhesive film 16 and into the patient until the base 92 of catheter 90 is seated in wedge seal 50, as illustrated in Figure 4C. In some embodiments, the protective adapter 30 comprises an accessory that prevents excessive insertion of the catheter 90 into the patient. For example, in some embodiments, aperture 33 comprises a diameter that is less than the outer diameter of base 92. As such, base 92 is prevented from passing through aperture 33. In other embodiments, aperture 33 comprises a chamfered surface that mirrors the tapered surface of base 92. As such, base 92 rests in opening 33 at a depth where base 92 is fully seated in wedge seal 50. [037] After catheterization, catheter insert 120 is detached from the Luer 10 fixture. In some embodiments, probe 130 and needle 140 are withdrawn into lumen 124 before detaching the member. of catheter insertion 120 from the Luer fixture 10. Upon withdrawal of probe 130 and needle 140 from membrane 40, cutout 43 automatically seals, thus preventing leakage of fluids from catheter 90 and lumen 36. [038] After removal of the catheter insert 120, the Luer fixture 10 can be further coupled to a fluid source, such as a fluid line 150 through a Luer connector 152, as illustrated in Figure 4D. In some embodiments, fluid line 150 comprises a probe or nozzle 154 that has passed through membrane 40 and into lumen 36. As such, fluid communication between the patient and fluid line 150 is facilitated through catheter 90 . [039] The present invention can be embodied in other specific forms without departing from its structures, methods or other essential features as widely described here and claimed hereinafter. All described modalities and examples are to be considered in any and all respects as illustrative only, and not restrictive. The scope of the invention is therefore indicated by the appended claims, rather than the description above. All changes that fall within the meaning and equivalence range of the claims must be encompassed within their scope.
权利要求:
Claims (15) [0001] 1. A catheter fixation device (10) (90), comprising: a flexible shield (12) having a base (14) configured to attach to a surface of a patient (100); a catheter adapter (20) coupled to the flexible shield (12), an inner surface of the adapter (20) comprising a wedge-type seal (50); and a membrane (40) disposed within the adapter (20) CHARACTERIZED by the fact that the wedge-type seal (50) comprises an annular seal having an inner diameter that is configured to receive a catheter (90) in which a portion (92) The base (14) of the catheter (90) rests within the wedge-type seal (50) to form a fluid impermeable seal. [0002] 2. Device (10) according to claim 1, CHARACTERIZED in that it further comprises a shield adapter (30) having a distal end coupled to a proximal end of the flexible shield (12), and having a proximal end coupled to the adapter (20). [0003] 3. Device (10) according to claim 1, CHARACTERIZED by the fact that the flexible protection (12) additionally comprises an adhesive film (16) that is sandwiched between the protection and the patient (100) when the device (10 ) is fixed to the patient's surface (100). [0004] 4. Device (10) according to claim 1, CHARACTERIZED by the fact that it additionally comprises a set of threads (32) positioned on a proximal end of the adapter (20). [0005] 5. Device (10) according to claim 1, CHARACTERIZED by the fact that the membrane (40) additionally comprises an automatic sealing cut (42). [0006] 6. Device (10) according to claim 1, CHARACTERIZED by the fact that the flexible protection (12) comprises a base (14) and a side wall (13), the base (14) being angled with respect to the side wall (13) from 30° to 90°. [0007] 7. Device (10) according to claim 6, CHARACTERIZED by the fact that the base (14) is angled with respect to the side wall (13) at 90°. [0008] 8. Device (10) according to claim 4, CHARACTERIZED by the fact that the catheter (90) is seated in the wedge-type seal (50) through an insert (120) of a catheter (90). [0009] 9. Device (10) according to claim 8, CHARACTERIZED by the fact that the insertion element (120) of catheter (90) is coupled to the adapter (20). [0010] 10. Method for manufacturing a catheter fixation device (10) (90) as defined in claim 1, CHARACTERIZED in that it comprises: providing a flexible shield (12) having a base (14) configured to attaching to a surface of a patient (100); coupling the flexible shield (12) to an adapter (20); inserting a wedge-type seal (50) into an inner surface of the adapter (20), wherein the wedge-type seal (50) comprises an annular seal having an inner diameter that is configured to receive a catheter (90) in which a base portion (92) of the catheter (90) rests within the wedge seal (50) to form a fluid impermeable seal; and disposing a membrane (40) within the adapter (20). [0011] 11. Method according to claim 10, CHARACTERIZED by the fact that it further comprises: providing a protective adapter (30) having a proximal end and a distal end; coupling the flexible shield (12) to the distal end of the shield adapter (30); and coupling the proximal end of the shield adapter (30) to a distal end of the adapter (20). [0012] 12. Method according to claim 11, CHARACTERIZED by the fact that it additionally comprises the attachment of an adhesive film (16) to the base (14) of the flexible protection (12), the adhesive film (16) enclosing an internal environment of the flexible protection (12). [0013] 13. Method according to claim 10, characterized in that it further comprises a step of providing a set of threads (32) on a proximal end of the adapter (20). [0014] 14. Method according to claim 10, CHARACTERIZED by the fact that the membrane (40) additionally comprises an automatic sealing cut (42). [0015] 15. Method according to claim 11, CHARACTERIZED in that it additionally comprises a step of angling the base (14) of the flexible shield (12) with respect to a side wall (13) of the flexible shield (12) to a angle from 30° to 90°.
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法律状态:
2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]| 2019-11-12| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]| 2021-01-26| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]| 2021-06-29| B09A| Decision: intention to grant [chapter 9.1 patent gazette]| 2021-08-17| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 10/09/2013, OBSERVADAS AS CONDICOES LEGAIS. |
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申请号 | 申请日 | 专利标题 US13/614,481|US9155866B2|2012-09-13|2012-09-13|Luer securement device| US13/614,481|2012-09-13| PCT/US2013/059053|WO2014043124A1|2012-09-13|2013-09-10|Luer securement device| 相关专利
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