Medical connector with integrated adhesive backing

Abstract

A holder for securing an venous access device to a patient can include a flexible substrate having an upper surface, a lower surface, and an outer peripheral surface. An adhesive layer can cover the lower surface of the flexible substrate. The adhesive layer can have an adhesive for adhering to the patient's skin. The holder can further include a hydrophilic matrix integrated into at least a portion of the adhesive layer, at least one solvent reservoir disposed on the upper surface of the flexible substrate, and a connector secured to the outer peripheral surface. The connector can have a first end for connection to a needle assembly and a second end for connection to an IV fluid line.

Description

Technical Field

[0001] The present disclosure generally relates to fixation devices for stabilizing intravenous access devices, and more particularly to holders having an integral adhesive backing for securing intravenous access devices, such as intravenous injection needles and their associated luer fittings, to a patient's skin.

Background Art

[0002] Intravenous (IV) needles are frequently used in medical procedures. As with any invasive procedure, IV-related infections are a major concern. When repeated access to the bloodstream is required, IV catheters are used. These catheters frequently use cylindrical luer fittings and valves as an alternative to conventional needle-based injection ports. However, to be effective, catheters must not only avoid bloodstream and local site infections, but also avoid dislodgement.

[0003] IV catheter fixation presents a number of challenges. To maximize dwell time, IV catheters must be fixed so as not to dislodge or cause damage from unwanted movement. Also, the insertion site should be readily inspected for contamination or infection and protected from contamination or infection. Preferably, the catheter port should also be readily repairable.

[0004] Conventional methods call for fixing the catheter insertion site with a gauze dressing or a transparent film with adhesive tape. Adhesive tape is problematic in that it is difficult to maintain a sterile state and is prone to irritating the patient's skin. The use of a transparent film is preferred because it serves as a pathogen barrier and allows the insertion site to be viewed. However, transparent films are problematic in that the film will eventually loosen from everyday contact and allow movement of the catheter.

[0005] The difference in diameter between the IV needle and the Luer fitting further complicates the fixation problem. While adhesive strips can be applied over the Luer fitting to secure it to the skin, the opaque tape obstructs visual inspection of the fitting. Furthermore, securing the Luer fitting under a transparent film or adhesive tape presents several problems, as the larger diameter of the Luer fitting acts as a spacer, creating a gap between the film or tape and the patient's skin. This gap undermines the infection barrier purpose of the fixation.

[0006] Descriptions provided in the background art chapter should not be considered prior art simply because they are mentioned in or associated with the background art chapter. The background art chapter may contain information describing one or more aspects of the subject art. [Overview of the project] [Means for solving the problem]

[0007] According to various embodiments of the present disclosure, a holder for securing a venous access device to a patient may include a flexible substrate having an upper surface, a lower surface, and an outer peripheral surface. An adhesive layer may cover the lower surface of the flexible substrate. The adhesive layer may have an adhesive for adhesion to the patient's skin. The holder may further include a hydrophilic matrix integrated with at least a portion of the adhesive layer, at least one solvent reservoir disposed on the upper surface of the flexible substrate, and a connector fixed to the outer peripheral surface. The connector may have a first end for connection to a needle assembly and a second end for connection to an IV fluid line.

[0008] According to various embodiments of the present disclosure, a method for assembling a holder for securing a venous access device to a patient may include the steps of selecting a flexible substrate containing a breathable material and placing an adhesive layer on the lower surface of the flexible substrate. The adhesive layer may have an adhesive for adhesion to the patient's skin. The method may further include the steps of fluidly connecting at least one solvent source to the adhesive layer and securing a connector to the outer surface of the flexible substrate. The connector may have a first end for connection to a needle assembly and a second end for connection to an IV fluid line.

[0009] According to various embodiments of the present disclosure, a holder for securing a venous access device to a patient may include a flexible substrate having an upper surface and a lower surface, a solvent delivery line connected to the upper surface of the flexible substrate, and an adhesive layer covering the lower surface of the flexible substrate. The adhesive layer may include an adhesive for adhesion to the patient's skin. The holder may further include a solvent pathway integrated into at least a portion of the adhesive layer and a connector fixed to the upper surface. The solvent pathway may include the solvent delivery line and at least one aperture for fluid connection to the solvent pathway. The connector may include a first end for connection to a needle assembly and a second end for connection to an IV fluid line.

[0010] It should be understood that both the general description above and the detailed description below are illustrative and descriptive, and are intended to provide a further description of the subject matter technology as claimed. It should also be understood that other embodiments may be used, and modifications may be made without departing from the scope of the subject matter technology.

[0011] The following figures are included to illustrate specific aspects of the embodiments and should not be viewed as exclusive embodiments. The disclosed subject matter is subject to considerable modification, substitution, combination, and equivalents in terms of form and function, as will be conceivable to those skilled in the art who are interested in this disclosure. [Brief explanation of the drawing]

[0012] [Figure 1] This is a perspective view of an IV set including a holder for securing a venous access device, according to some embodiments of the present disclosure. [Figure 2] This is a perspective view of a holder for securing a venous access device according to some embodiments of the present disclosure. [Figure 3] Figure 2 is a front view of a holder according to some embodiments of the present disclosure. [Figure 4] This is a bottom view of the holder according to some embodiments of the present disclosure. [Figure 5] Figure 2 is a top view of the holder according to some embodiments of the present disclosure. [Figure 6] This is a bottom view of the holder connector shown in Figure 2, according to some embodiments of the present disclosure. [Figure 7] This is a perspective top view of a holder for securing a venous access device according to some embodiments of the present disclosure. [Figure 8] This is a bottom view of the holder shown in Figure 7, according to some embodiments of the present disclosure. [Modes for carrying out the invention]

[0013] The detailed description below illustrates various configurations of the subject art and is not intended to represent only the configurations in which the subject art can be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject art. Thus, dimensions may be provided as non-limiting examples with respect to certain embodiments. However, it will be apparent to those skilled in the art that the subject art can be practiced without these specific details. In some cases, to avoid obscuring the concepts of the subject art, well-known structures and components are shown in the form of block diagrams.

[0014] It should be understood that this disclosure includes examples of the subject art and does not limit the scope of the appended claims. Herein, various aspects of the subject art are disclosed in accordance with specific but non-limiting examples. The various embodiments described in this disclosure may be carried out in different ways and variations and may be carried out according to a desired use or implementation.

[0015] Various embodiments of the present disclosure generally relate to fixation devices for stabilizing venous access devices, and more particularly to holders having an integrated adhesive backing material for fixing venous access devices (e.g., intravenous needles and their associated Luer fittings, etc.) to the patient's skin.

[0016] As used herein, the terms “medical connector,” “connector,” “fitting,” and any variations thereof refer to any device used to provide a fluid passage between fluid lines connected thereto. For example, a medical connector may be or contain a bond pocket or other type of connector. Additionally, the terms “medical connector,” “connector,” “fitting,” and any variations thereof refer to any device used to deliver liquids, solvents, or fluids to or from a patient under medical care. For example, a medical connector may be used for intravenous (IV) delivery of fluids to a patient, fluid drainage, oxygen delivery, and combinations thereof.

[0017] In some embodiments, the holder may include a flexible substrate having an upper surface, a lower surface, and an outer peripheral surface. Connectors (e.g., male Luer lock fittings) may be coupled to the surface of the flexible substrate to connect to a venous access device in order to secure the venous access device to the patient via the holder. An adhesive layer or adhesive backing material may cover the lower surface of the flexible substrate. The adhesive layer or adhesive backing material 120 may be coated, bonded, fastened, or otherwise attached to the lower surface of the flexible substrate. The adhesive layer or adhesive backing material may contain an adhesive for bonding the holder, which has the intravenous needle assembly and associated connector (e.g., Luer lock fitting), to the patient's skin. A hydrophilic matrix may be integrated into the adhesive backing material. One or more solvent reservoirs containing solvents that are harmful to the adhesive but safe for skin contact may be disposed on the upper surface of the flexible substrate. One or more solvent reservoirs may each have a hollow interior, which is fluidly in communication with a hydrophilic matrix integrated into the adhesive layer or adhesive backing material. A barrier may be included between the hydrophilic matrix and each solvent reservoir. Before removal from the patient's skin, the barrier may be removed, allowing the solvent to be absorbed throughout the hydrophilic matrix. The solvent can then begin to dissolve the adhesive binding the connector to the patient's skin. After the solvent has been allowed to break down the adhesive, the clinician may be able to remove the Luer lock fitting from the patient's skin without causing injury or pain.

[0018] In some embodiments, the holder may include a flexible substrate and an adhesive layer or adhesive backing covering the lower surface of the flexible substrate, and a solvent pathway may be integrated into at least a portion of the adhesive layer or adhesive backing. The holder may further include at least one solvent delivery line connected to the upper surface of the flexible substrate. The solvent delivery line may be configured to transport a solvent from a solvent source (e.g., a syringe) into the solvent pathway. Thus, the solvent pathway may be provided for a clinician to inject a dissolving solvent onto the surface of the skin and thereby weaken the adhesive bond. When the clinician injects the fluid, the flexible substrate inflates like a balloon, allowing the fluid to reach further parts of the adhesive and gently dissolve and peel away the adhesive layer throughout the holder.

[0019] The holder configuration described above is advantageous over prior art dressing and bonding methods (e.g., taping) for needles and needle assemblies that directly adhere the needle assembly and associated connector (e.g., male Luer lock fitting) to the patient's skin. For example, by incorporating a fixing mechanism within the male Luer lock fitting (i.e., by connecting the needle assembly to the holder 100 via the Luer lock fitting, and then attaching the holder to the patient), further isolation can be provided in cases where the needle assembly being used contains a short extension tube. Given the above configuration of the holder, the short extension tube can eliminate small dynamic loads, thereby preventing these loads from being applied to the needle assembly being inserted into the patient.

[0020] FIG. 1 is a perspective view of an IV set including a medical connector according to some embodiments of the present disclosure. As shown in FIG. 1, the IV set 10 includes holders 100 and 200 therein. The IV set 10 includes a main fluid system 2 and an auxiliary fluid system 4. An IV pump (not shown) receives fluid from the main fluid system 2 and the branch or auxiliary fluid system 4 via a supply line 5, and then controls and dispenses the fluid to a patient 50.

[0021] The main fluid system 2 includes a main fluid source (e.g., a fluid bag 3, etc.), and the main fluid source can contain or be capable of containing an aqueous saline solution or other fluid to be administered to a patient. As shown, a tube 6 conveys the flow from a drip chamber 7 to a Y-connector 12. A check valve 14 is disposed in the tube 6 upstream from the Y-connector 12, allowing flow from the fluid bag 3 to an IV pump (not shown) while preventing backflow of fluid from the auxiliary fluid system 4 toward the fluid bag 3.

[0022] The auxiliary fluid system 4 includes an auxiliary fluid source such as a fluid bag 8, which can contain a drug or other fluid to be supplied to a patient for treatment. An auxiliary fluid line 9 conveys the flow from a drip chamber 11 to the Y-connector 12.

[0023] The present disclosure generally relates to a fixation device for stabilizing a venous access device, and more particularly to a holder having an integral adhesive backing for fixing a venous access device (e.g., an intravenous needle and their associated luer fittings, etc.) to a patient's skin.

[0024] Figure 2 is a perspective view of a holder 100 for securing a venous access device according to some embodiments of the present disclosure. Figure 3 is a front view of the holder of Figure 2 according to some embodiments of the present disclosure. Referring to Figure 2, the holder 100 may include a flexible substrate 105, which has an upper surface 110, a lower surface 115, and an outer peripheral surface 117. In some embodiments, the flexible substrate 105 may be formed from urethane or a similar material, which is flexible, transparent, breathable, and sterilizable to minimize contamination when the IV holder 100 is applied to the patient's skin. In some embodiments, the flexible substrate 105 may be formed from or include at least one of foam, silicone, soft plastic, rubber, or elastomer.

[0025] As illustrated in Figure 3, the adhesive layer or adhesive backing material 120 can cover the lower surface 115 of the flexible substrate 105. In some embodiments, the adhesive layer or adhesive backing material 120 may be bonded, fastened, or otherwise attached to the lower surface 115 of the flexible substrate 105. However, various embodiments of the present disclosure are not limited to the configurations described above. In some embodiments, the adhesive layer or adhesive backing material 120 may be in the form of a coating (e.g., an adhesive coated on the lower surface 115 of the flexible substrate 105). The adhesive layer or adhesive backing material 120 may include an adhesive for bonding a holder 100 having an intravenous needle assembly and associated connectors (e.g., Luer fittings) to the skin of a patient 50.

[0026] Figure 4 is a bottom view of the holder of Figure 2 according to some embodiments of the present disclosure. In some embodiments, the hydrophilic matrix 125 may be integrated into at least a portion of the adhesive layer or adhesive backing material 120. As shown, the hydrophilic matrix 125 is integrated throughout the entire adhesive layer or adhesive backing material 120. However, various embodiments of the present disclosure are not limited to the above-described configuration. In some embodiments, the hydrophilic matrix 125 may be integrated into only a portion of the adhesive layer or adhesive backing material 120.

[0027] Figure 5 is a top view of the holder of Figure 2 according to some embodiments of the present disclosure. Figure 6 is a bottom view of the holder connector of Figure 2 according to some embodiments of the present disclosure. In some embodiments, the holder 100 may include at least one solvent reservoir 130 disposed on the upper surface 110 of the flexible substrate 105. As shown, two solvent reservoirs 130 may be disposed on the upper surface 110. However, various embodiments of the present disclosure are not limited to the above configurations. In some embodiments, the holder may include only one solvent reservoir. In yet another embodiment, the holder 100 may include three or more solvent reservoirs 130. The solvent reservoir may be a cylindrical body portion configured to contain a hollow interior for holding a solvent therein. Although the solvent reservoir 130 is shown to be cylindrical in shape, various embodiments of the present disclosure are not limited to this configuration. In other embodiments, the solvent reservoir 130 may be of any shape (e.g., circular, rectangular, or other polygonal shape). The solvent reservoir 130 may contain a solvent that, when absorbed into the hydrophilic matrix, can decompose or otherwise dissolve the adhesive in the adhesive layer or adhesive backing material 105. In some embodiments, the solvent may be isopropyl alcohol.

[0028] In some embodiments, at least one solvent reservoir 130 may have a hollow interior that is fluidically in communication with a hydrophilic matrix 125 integrated into the adhesive layer or adhesive backing material 120. For example, the flexible substrate 105 may include cutouts or longitudinally extending apertures at positions corresponding to the locations of each solvent reservoir 130. Thus, the solvent contained in the solvent reservoir 130 can flow into and be absorbed into the hydrophilic matrix 125 of the adhesive layer or adhesive backing material 120. Before removal of the holder 100 from the patient's skin, a barrier 135 having a shape and size corresponding to the aperture that fluidly communicates the solvent reservoir 130 and the adhesive layer or adhesive backing material 120 may be interposed between the solvent reservoir 130 and the adhesive layer or adhesive backing material 120 to close the aperture or otherwise block it. Therefore, fluid communication between the solvent reservoir 130 and the adhesive layer or adhesive backing material 120 may be blocked until it is desired to remove the holder 100 from the patient's skin. Thus, the barrier 135 can act as or serve as a removable base for the solvent reservoir 130, which is removable to expose the solvent to the adhesive layer or adhesive backing material 120.

[0029] According to various embodiments of this disclosure, the holder 100 may further include a connector 140 fixed to the outer peripheral surface 117 of the flexible substrate. The connector 140 may have a first end 145 for connection to a needle assembly (e.g., a catheter) and a second end 150 for connection to an IV fluid line (e.g., an IV supply line 5). For example, the connector 140 may be a Luer lock fitting, and not limited to, a male Luer lock fitting. In these embodiments, the first end 145 of the male Luer lock fitting may have a spin lock collar 155 for screw-type engagement and connection of a needle assembly (e.g., a catheter or other needle device) which will be inserted into the patient's body through the skin. Thus, the needle assembly may be attached to or bonded to the patient's skin via the holder 100. The above configuration is advantageous over prior art dressing and bonding methods (e.g., taping) of needles and needle assemblies that directly adhere the needle assembly and associated connector (e.g., male Luer lock fitting) to the patient's skin. For example, by incorporating a fixation mechanism within the male Luer lock fitting (i.e., by connecting the needle assembly to the holder 100 via the Luer lock fitting 140, and then attaching the holder 100 to the patient), further isolation can be provided in cases where the needle assembly being used contains a short extension tube. Given the above configuration of the holder 100, the short extension tube can eliminate small dynamic loads, thereby preventing these loads from being applied to the needle assembly being inserted into the patient.

[0030] While not strictly necessary, there may be benefits to be gained if the holder 100 is longer (i.e., in the Y direction) than wider (i.e., in the X direction). A narrower width can provide better support and fixation of the holder 100. Additionally, a longer length may allow for added versatility in positioning the holder 100 relative to the luer lock fitting 140.

[0031] During operation, the needle assembly (for example, a catheter or other needle device to be inserted into the patient's body) can be screw-engaged to the first end 145 of the Luer-lock fitting 140 via the spin-lock collar 155. The lower surface 115 of the holder 100 can then be pressed against the patient's skin, exposing the adhesive layer or adhesive backing material 120, which can then be bonded to the patient's skin. Thus, the needle assembly can be firmly attached to or bonded to the patient's skin via the holder 100. The IV supply line 5 can then be connected to the second end 150 of the Luer-lock fitting 140 to deliver fluid or other drugs from the IV supply line 5 to the patient via the needle assembly. Once the fluid has been administered to the patient's body via the needle assembly and / or removed from the patient's body, the holder 100 can be removed from the patient's skin as detailed below.

[0032] If it is necessary to remove the needle assembly from the Luer lock fitting 140 for service and / or to remove the needle from the needle assembly, the Luer lock fitting 140 can be unscrewed from the needle assembly via the spinlock collar 155.

[0033] When it is desired to remove the holder 100 from the patient's skin, the barrier 135 is removed, thereby opening the fluid connection between the solvent chamber 130 and the adhesive layer or adhesive backing material 120. Thus, the solvent can flow from the solvent chamber 130 into the adhesive layer or adhesive backing material 120. In particular, the solvent can flow into the hydrophilic matrix 125 within the adhesive layer or adhesive backing material 120 and be absorbed throughout the hydrophilic matrix 125. The solvent can then begin to dissolve the adhesive in the adhesive layer or adhesive backing material 120 that bonds the Luer lock fitting 140 to the patient's skin. As the solvent dissolves and breaks down the adhesive, clinicians or other users may be able to remove the male Luer lock fitting from the patient's skin advantageously without causing damage or pain. Further advantageously, by incorporating means for adhesive removal as described above, a wider selection of adhesives may be available for use, potentially leading to improved fixation architectures than current fixation devices. For example, the above method of removing the holder from the patient's skin can allow the use of stronger adhesives without the risks that may be seen in conventional fixation methods, or without injuring or damaging the patient's skin. Furthermore, the adhesive layer or adhesive backing material 120 provides a fixation method that further reduces the risk of needle assembly (e.g., catheter or other needle device) detachment.

[0034] Figure 7 is a perspective top view of a holder 200 for securing a venous access device according to some embodiments of the present disclosure. Figure 8 is a bottom view of the holder 200 of Figure 7 according to some embodiments of the present disclosure. Referring to Figures 7 and 8, the holder 200 may include a flexible substrate 205, which has an upper surface 210 and a lower surface 215. In some embodiments, the flexible substrate 205 may be formed from urethane or a similar material, which is flexible, transparent, breathable and sterilizable to minimize contamination when the IV holder 200 is applied to the patient's skin. In some embodiments, the flexible substrate 105 may be formed from or include at least one of foam, silicone, soft plastic, rubber or elastomer.

[0035] As illustrated in Figure 8, the adhesive layer or adhesive backing material 220 can cover the lower surface 215 of the flexible substrate 205. In some embodiments, the adhesive layer or adhesive backing material 220 can be bonded, fastened, or otherwise attached to the lower surface 215 of the flexible substrate 205. However, various embodiments of the present disclosure are not limited to the configurations described above. In some embodiments, the adhesive layer or adhesive backing material 220 can be in the form of a coating (e.g., an adhesive coated on the lower surface 215 of the flexible substrate 205). The adhesive layer or adhesive backing material 220 can include an adhesive for bonding a holder 200 having an intravenous needle assembly and associated connectors (e.g., Luer fittings) to the skin of a patient 50.

[0036] In some embodiments, the solvent pathway 225 may be integrated into at least a portion of the adhesive layer or adhesive backing material 220. As shown, the solvent pathway 225 is integrated throughout the entire adhesive layer or adhesive backing material 220. However, various embodiments of the present disclosure are not limited to the above configuration. In some embodiments, the solvent pathway 225 may be integrated into only a portion of the adhesive layer or adhesive backing material 220.

[0037] The holder 200 may include at least one solvent delivery line 255 connected to the upper surface 210 of the flexible substrate 205. As shown, one solvent delivery line 255 may be connected to the upper surface 210. However, various embodiments of the present disclosure are not limited to the above configuration. In some embodiments, the holder 200 may include two or more solvent delivery lines 255. The solvent delivery line 255 may be configured to transport a solvent from a solvent source (e.g., a syringe) into a solvent pathway 225. Thus, the solvent pathway 225 may include at least one aperture 235 for fluidly connecting the solvent delivery line 255 and the solvent pathway 225. As shown, the solvent pathway 225 includes one aperture 225. However, various embodiments of the present disclosure are not limited to the above configuration. In some embodiments, the solvent pathway 225 may include two or more apertures 235. As shown, the solvent delivery line 255 may have a hollow interior, which is fluidly connected to a solvent pathway 225 integrated into the adhesive layer or adhesive backing material 120. Thus, the solvent delivery line 255 may be a vessel for transporting a solvent from a solvent source (e.g., a syringe) through an aperture 235 into the solvent pathway 225 of the adhesive layer or adhesive backing material 220. The solvent pathway may be interposed between the patient's skin and the adhesive layer or adhesive backing material 220 when the holder 200 is adhered to the patient's skin. The solvent may contain a solvent that can decompose or otherwise dissolve the adhesive in the adhesive layer or adhesive backing material 205 when the solvent is absorbed into the solvent pathway 225, as will be described in more detail below. In some embodiments, the solvent may be isopropyl alcohol.

[0038] According to various embodiments of the present disclosure, the solvent delivery line may have a first end 260 with a syringe connection portion 265 and a second end 250 connected to at least one aperture 235. As shown, the syringe connection portion 265 may be formed as a housing, which is adapted to receive a syringe containing a solvent configured to dissolve and decompose at least a portion of the adhesive layer or adhesive backing material 220.

[0039] According to various embodiments of this disclosure, the holder 200 may further include a connector 240 fixed to the upper surface 210 of the flexible substrate 205. The connector 240 may have a first end 145 for connection to a needle assembly (e.g., a catheter) and a second end 150 for connection to an IV fluid line (e.g., an IV supply line 5). For example, the connector 240 may be a Luer lock fitting, and not limited to, a male Luer lock fitting. In these embodiments, the first end 145 of the male Luer lock fitting may have a spin lock collar 155 for screw-type engagement and connection of a needle assembly (e.g., a catheter or other needle device) which will be inserted into the patient's body through the skin. Thus, the needle assembly may be attached to or bonded to the patient's skin via the holder 200. The above configuration is advantageous over prior art dressing and bonding methods (e.g., taping) of needles and needle assemblies that directly adhere the needle assembly and associated connector (e.g., male Luer lock fitting) to the patient's skin. For example, by incorporating a fixation mechanism within the male Luer lock fitting (i.e., by connecting the needle assembly to the holder 200 via the Luer lock fitting 240, and then attaching the holder 200 to the patient), further isolation can be provided in cases where the needle assembly being used contains a short extension tube. Given the above configuration of the holder 200, the short extension tube can eliminate small dynamic loads, thereby preventing these loads from being applied to the needle assembly being inserted into the patient.

[0040] While not strictly necessary, there may be benefits to be gained if the holder 200 is longer (i.e., in the Y direction) than wider (i.e., in the X direction). A narrower width can provide better support and fixation of the holder 200. Additionally, a longer length may allow for added versatility in positioning the holder 200 relative to the luer lock fitting 240.

[0041] During operation, the needle assembly (for example, a catheter or other needle device to be inserted into the patient's body) can be screw-engaged to the first end 145 of the Luer-lock fitting 240 via the spin-lock collar 155. The lower surface 215 of the holder 200 can then be pressed against the patient's skin, exposing the adhesive layer or adhesive backing material 220, which can then be bonded to the patient's skin. Thus, the needle assembly can be firmly attached to or bonded to the patient's skin via the holder 200. The IV supply line 5 can then be connected to the second end 150 of the Luer-lock fitting 240 to deliver fluid or other drugs from the IV supply line 5 to the patient via the needle assembly. Once the fluid has been administered to the patient's body via the needle assembly and / or removed from the patient's body, the holder 200 can be removed from the patient's skin as detailed below. If it is necessary to remove the needle assembly from the Luer lock fitting 240 for service and / or to remove the needle from the needle assembly, the Luer lock fitting 240 can be unscrewed from the needle assembly via the spinlock collar 155.

[0042] When it is desired to remove the holder 200 from the patient's skin, a syringe containing the solvent may be connected to or otherwise attached to the syringe connection portion 265. The solvent can then be injected from the syringe into the solvent delivery line 255 and transported through the aperture 250 to the solvent pathway 225. Thus, the solvent can flow from the solvent pathway 225 into the adhesive layer or adhesive backing material 220. In particular, the solvent can flow into the legs 230 and 240 of the solvent pathway 225 and be absorbed throughout the legs 230 and 240. The solvent can then begin to dissolve the adhesive in the adhesive layer or adhesive backing material 220 that bonds the Luer lock fitting 240 to the patient's skin. As the solvent is delivered into the solvent pathway 225, the flexible substrate 205 is able to inflate like a balloon or expand in other ways, allowing the solvent to reach further parts of the adhesive layer or adhesive backing material 220 and gently dissolve and peel away the adhesive layer or adhesive backing material 220 throughout the holder 200.

[0043] The solvent dissolves and breaks down the adhesive, causing the underside surface of the flexible substrate 205 to bulge like a balloon and detach from the patient's skin, so that clinicians or other users may be able to remove the male Luer lock fitting 240 from the patient's skin advantageously without causing injury or pain. Further advantageously, the above method of removing the holder 200 from the patient's skin may allow the use of stronger adhesives without the risks that may be seen in conventional fixation methods, or without injuring or damaging the patient's skin. Moreover, the adhesive layer or adhesive backing material 220 provides a fixation method that further reduces the risk of needle assembly (e.g., catheter or other needle device) detachment.

[0044] This disclosure is provided to enable any person skilled in the art to practice the various embodiments described herein. This disclosure provides various examples of the subject art, and the subject art is not limited to these examples. Various modifications to these embodiments will be readily apparent to a person skilled in the art, and the general principles set forth herein may also apply to other embodiments.

[0045] References to elements in the singular form are intended to mean "one or more" and not "only" unless specifically stated otherwise. The term "several" refers to "one or more" unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and that), and vice versa. Headings and subheadings (where present) are used merely for convenience and do not limit the invention.

[0046] The term “exemplary” is used herein to mean “serving as an example or illustration.” Any embodiment or design described herein as “exemplary” should not necessarily be construed as being superior or advantageous to other embodiments or designs. In one embodiment, various alternative configurations and operations described herein may be considered at least equivalent.

[0047] As used herein, the phrase “at least one of” preceding a set of items (with the term “or” to distinguish any of the items) modifies the list as a whole, rather than each individual item in the list. The phrase “at least one of” does not require the selection of at least one item. Rather, the phrase allows for meanings that include at least one of any one of the items, and / or at least one of any combination, and / or at least one of each of the items. For example, the phrase “at least one of A, B, or C” could refer to A only, B only, or C only; or any combination of A, B, and C.

[0048] The phrase "aspect" does not imply that such aspect is essential to the subject art, or that such aspect applies to all configurations of the subject art. Disclosure relating to an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. The phrase "aspect," etc., may refer to one or more aspects, and vice versa. The phrase "embodiment," etc., does not imply that such embodiment is essential to the subject art, or that such embodiment applies to all configurations of the subject art. Disclosure relating to an embodiment may apply to all embodiments, or to one or more embodiments. An embodiment may provide one or more examples. The phrase "such embodiment" may refer to one or more embodiments, and vice versa. The phrase "configuration," etc., does not imply that such configuration is essential to the subject art, or that such configuration applies to all configurations of the subject art. Disclosure relating to a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. The phrase "such a configuration" can refer to one or more configurations, and vice versa.

[0049] In one aspect, unless otherwise stated, all measurements, values, ratings, locations, sizes, dimensions, and other specifications described herein (including the claims that follow) are approximate and not precise. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they relate and with the functions that are customary in the art to which they relate.

[0050] It is understood that any particular order or hierarchy of actions or methods in the disclosed steps or processes is illustrative of an exemplary approach. It is understood that any particular order or hierarchy of steps, actions or processes may be rearranged based on preferred implementations or scenarios. Some of the steps, actions or processes may be performed simultaneously. In some preferred implementations or scenarios, certain actions may or may not be performed. Some or all of the steps, actions or processes may be performed automatically without user intervention. The attached claims for the methods present various elements of steps, actions or processes in a sample order and are not intended to be limited to any particular order or hierarchy presented.

[0051] All structural and functional equivalents to the various aspects of the elements described throughout this disclosure, whether known to those skilled in the art or to be subsequently known to those skilled in the art, are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, whether such disclosure is expressly contained in the claims or not. No element of a claim should be construed under Section 112(f) of the United States Patent Act unless that element is expressly described using the phrase “means for” or, in the case of a method claim, “step for.” Furthermore, to the extent that terms such as “include” or “have” are used, such terms are intended to be comprehensive in the same manner as the term “comprise,” so that when used as a transitional clause in a claim, “comprise” is construed.

[0052] The Title of the Invention, Background Art, Summary of the Invention, Brief Description of the Drawings, and Abstract of the Disclosure are thus incorporated into the Disclosure and are provided as illustrative examples, not as restrictive descriptions. They are submitted with the understanding that they are not to be used to limit the claims or their meaning. In addition, in the Detailed Description, it can be understood that the Description provides illustrative examples and that various features are grouped together in various embodiments for the purpose of streamlining the Disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed subject matter requires more features than those expressly described in each claim. Rather, as reflected in the following claims, the subject matter of the Invention is fewer than all features of a single disclosed configuration or operation. The following claims are thus incorporated into the Detailed Description, and each claim stands alone as a separate claimed subject matter.

[0053] The claims are not intended to be limited to the embodiments described herein, but rather to be given a full scope consistent with the language of the claims and intended to encompass all legal equivalents. Nevertheless, none of the claims are intended, nor should they be construed, to encompass subject matter that does not satisfy the requirements of Section 101, 102, or 103 of the U.S. Patent Act.

Claims

1. A holder for securing a venous access device to a patient, wherein the holder is A flexible substrate having an upper surface, a lower surface, and an outer peripheral surface; An adhesive layer covering the lower surface of the flexible substrate, wherein the adhesive layer has an adhesive for adhering to the patient's skin; A hydrophilic matrix integrated into at least a portion of the adhesive layer; Disposed on the upper surface of the flexible substrate and fluidly connected to the adhesive layer, the solvent reservoir is configured to contain a solvent for decomposing the adhesive; A connector fixed to the outer surface, the connector having a first end including a Luer lock fitting for connection to a needle assembly, and a second end for connection to an IV fluid line. A holder that includes this.

2. The holder according to claim 1, further comprising a removable barrier interposed between the hydrophilic matrix and the at least one solvent reservoir.

3. The holder according to claim 1, wherein the flexible substrate comprises at least one of foam, silicone, soft plastic, rubber, or elastomer.

4. The holder according to claim 1, wherein the solvent reservoir contains a solvent configured to dissolve at least a portion of the adhesive.

5. The holder according to claim 4, wherein the hydrophilic matrix comprises a hydrophilic material capable of absorbing the solvent.

6. The holder according to claim 4, wherein the solvent comprises isopropyl alcohol.

7. The holder according to claim 1, wherein the lure lock fitting includes a spin lock collar.

8. A method for assembling a holder for securing a venous access device to a patient, the method being: The steps include: selecting a flexible substrate containing a breathable material; Steps include: placing an adhesive layer on the lower surface of the flexible substrate, wherein the adhesive layer has an adhesive for adhering to the patient's skin; The steps include: fluidly connecting at least one solvent source to the adhesive layer; A step of fixing a connector to the outer peripheral surface of the flexible substrate, wherein the connector includes a first end with a Luer lock fitting for connection to a needle assembly, and a second end for connection to an IV fluid line. Methods that include...

9. The method according to claim 8, further comprising the step of integrating a hydrophilic matrix into at least a portion of the adhesive layer.

10. The step of fluidly connecting at least one solvent source to the adhesive layer is, The steps include positioning at least one solvent reservoir on the upper surface of the flexible substrate; The steps include interposing a removable barrier between the at least one solvent reservoir and the upper surface of the flexible substrate. The method according to claim 9, including the method described in claim 9.

11. The method according to claim 8, further comprising the step of integrating a solvent pathway comprising at least one aperture into at least a portion of the adhesive layer.

12. The method according to claim 11, wherein the step of fluidly connecting at least one solvent source to the adhesive layer includes the step of fluidly connecting a solvent delivery line to the solvent path via the at least one aperture, the solvent delivery line being disposed on the upper surface of the flexible substrate.

13. The method according to claim 8, wherein the solvent of the at least one solvent source comprises isopropyl alcohol.

14. A holder for securing a venous access device to a patient, wherein the holder is A flexible substrate having an upper surface and a lower surface; A solvent delivery line connected to the upper surface of the flexible substrate; An adhesive layer covering the lower surface of the flexible substrate, wherein the adhesive layer has an adhesive for adhering to the patient's skin; A solvent pathway integrated into at least a portion of the adhesive layer, wherein the solvent pathway includes the solvent delivery line and at least one aperture for fluid connection to the solvent pathway; A connector fixed to the upper surface, the connector having a first end including a Luer lock fitting for connection to a needle assembly, and a second end for connection to an IV fluid line. A holder that includes this.

15. The holder according to claim 14, wherein the flexible substrate comprises at least one of foam, silicone, soft plastic, rubber, or elastomer.

16. The holder according to claim 14, wherein the solvent delivery line includes a first end having a syringe connection portion and a second end connected to the at least one aperture.

17. The holder according to claim 16, wherein the syringe connection portion includes a housing adapted to receive a syringe containing a solvent configured to dissolve and decompose at least a portion of the adhesive layer.

18. The holder according to claim 17, wherein the solvent comprises isopropyl alcohol.

19. The holder according to claim 14, wherein the solvent pathway is interposed between the patient's skin and the adhesive layer when the holder is in contact with the patient's skin.

20. The holder according to claim 14, wherein the lure lock fitting includes a spin lock collar.

Images