Patent Description:
Intravenous (IV) needles are frequently used in medical procedures. As with any invasive procedure, IV-related infections are a significant concern. Where repeated access to the bloodstream is needed, IV catheters are used. These catheters frequently use cylindrical Luer fittings and valves as an alternative to traditional needle based injection ports. However, in order to be effective, catheters must avoid dislodgment as well as avoid bloodstream infection and local site infection.

IV catheter securement poses a number of challenges. In order to maximize residence time, IV catheters must be secured from dislodgement or causing damage from unwanted movement. The insertion site should also be easily inspected for and protected from contamination or infection. Preferably, the catheter port can also be readily serviced.

Traditional methods call for securing 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 keep sterile and is prone to irritate a patient's skin. The use of a transparent film is preferable since it serves as a pathogenic barrier and permits viewing of the insertion site. However, transparent films are problematic in that the film eventually loosens from casual contact and permits catheter migration.

The disparity in diameter between an IV needle and a Luer fitting further complicates the securement problem. While an adhesive strip can be taped over the Luer fitting to secure the luer fitting to the skin, the opaque tape prevents visual inspection of the Luer fitting. Moreover, securing the Luer fitting under a transparent film or under adhesive tape is problematic in that the larger diameter of the Luer fitting acts as a spacer and creates a gap between the film or tape and the patient's skin. This gap compromises the infection barrier purpose of securement.

<CIT> discloses a patient access site securement system including a housing with an inlet, an outlet and an internal fluid path between the inlet and the outlet. The housing also has a connecting portion that connects to a catheter and/or a fluid line attached to the catheter. A contact surface is located on an underside of the housing and positions the patient access site securement system on the patient. A first reservoir with an interior holds a liquid and transitions from a first state to a second state. The interior is in fluid communication with the inlet when the reservoir is in the second state to allow the liquid to flow from the inlet, through the internal fluid path and exit the outlet. The liquid interacts with the contact surface and/or the patient to alter a level of securement between the catheter and the patient.

<CIT> Al discloses a barrier system for use in reducing infections associated with a percutaneous medical device, such as a catheter, that is disposed within a percutaneous incision. Such a barrier system can include: a barrier device having a skin-contacting surface and a catheter-receiving surface; and an adhesive composition configured for adhering to skin, the barrier device, and/or the catheter so as to form a barrier at or adjacent to an incision in the skin where the catheter is percutaneously inserted through the skin. The barrier device can include a conduit configured to receive the catheter. Alternatively, the barrier device can include a groove in a base surface that is configured to receive the catheter. A system that includes a medical device, the barrier device, and adhesive can also be provided.

Further relevant prior art can be found in <CIT> and <CIT>.

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 perimetal surface. An adhesive layer may overlay the lower surface of the flexible substrate. The adhesive layer may have an adhesive for adhering to skin of the patient. The holder may 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 perimetal 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.

According to various examples of the present disclosure, a not claimed method of assembling a holder for securing a venous access device to a patient may include selecting a flexible substrate including a breathable material, and placing an adhesive layer over a lower surface of the flexible substrate. The adhesive layer may have an adhesive for adhering to skin of the patient. The method may further include fluidly coupling at least one solvent source to the adhesive layer, and securing a connector to an outer perimetal 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.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology as claimed. It is also to be understood that other aspects may be utilized, and changes may be made.

The following figures are included to illustrate certain aspects of the embodiments, and should not be viewed as exclusive embodiments. The subject matter disclosed is capable of considerable modifications, alterations, combinations, and equivalents in form and function, as will occur to those skilled in the art and having the benefit of this disclosure.

Various embodiments of the present disclosure are generally directed to securement devices for stabilizing venous access devices, and, in particular, to a holder having an integrated adhesive backing for securing venous access devices such as intravenous needles and their associated luer fittings to a patient's skin.

As used herein, the terms "medical connector," "connector," "fitting," and any variation thereof refer to any device used to provide a fluid flow path between fluid lines coupled thereto. For example, the medical connector may be or include a bond pocket or other types of connectors. Additionally, the terms "medical connector," "connector," "fitting," and any variation thereof refer to any device used to deliver liquids, solvents, or fluids to or from a patient under medical care. For example, the medical connector may be used for intravenous (IV) delivery of fluids, fluid drainage, oxygen delivery, a combination thereof, and the like to the patient.

In some embodiments, a holder may include a flexible substrate having an upper surface, a lower surface, and an outer perimetal surface. A connector (e.g., a male luer lock fitting) may be coupled to a surface of the flexible substrate for connecting to a venous access device in order to secure the venous access device to the patient via the holder. An adhesive layer or backing may overlay the lower surface of the flexible substrate. The adhesive layer or backing <NUM> may be coated, adhered, fastened or otherwise attached to the lower surface of the flexible substrate. The adhesive layer or backing may include an adhesive for adhering the holder having an intravenous needle assembly and associated connector (e.g., luer lock fitting) to skin of the patient. A hydrophilic matrix may integrated into the adhesive backing. One or more solvent reservoirs containing a solvent deleterious to the adhesive but safe for skin contact may be disposed on the upper surface of the flexible substrate. The one or more solvent reservoirs may each have a hollow interior which is fluidly communicated with the hydrophilic matrix that is integrated into the adhesive layer or backing. A barrier may be included between the hydrophilic matrix and each solvent reservoir. Prior to removal from the patient's skin, the barrier may be removed and the solvent allowed to absorb throughout the hydrophilic matrix. The solvent may then begin to dissolve the adhesive bonding the connector and 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 damage or pain.

In some embodiments, a holder may include a flexible substrate, an adhesive layer or backing overlaying a lower surface of the flexible substrate, a solvent pathway may be integrated into at least a portion of the adhesive layer or backing. The holder may further include at least one solvent delivery line coupled to an 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. Accordingly, the solvent pathway may be provided for the clinician to inject the dissolving solvent onto the surface of the skin and thereby weaken the adhesive bond. As the clinician injects the fluid, the flexible substrate will balloon, allowing the fluid to reach further parts of the adhesive and gently dissolve & peel away the adhesive layer throughout the holder.

The aforementioned holder configurations are advantageous over prior art dressings and adhesive methods (e.g., taping) of needles and needle assemblies which directly adhere the needle assembly and associated connector (e.g., male luer lock fitting) to the patient's skin. For example, by incorporating the securement mechanism in the male luer lock fitting (i.e., by connecting the needle assembly to the holder <NUM> via the luer lock fitting and then attaching the holder to the patient), further isolation may be provided in cases where the needle assembly that is being used contains a short extension tube. Given the aforementioned configuration of the holder, the short extension tube may filter out small dynamic loads and thereby not impart these loads onto the needle assembly that is inserted into the patient.

<FIG> is a perspective view of an IV set including a medical connector in accordance with some embodiments of the present disclosure. As illustrated in <FIG>, an IV set <NUM> includes the holder <NUM>, <NUM> therein. IV set <NUM> includes a main fluid system <NUM> and an auxiliary fluid system <NUM>. An IV pump (not shown) receives fluid from main fluid system <NUM> and branch or auxiliary fluid system <NUM> via a supply line <NUM> and controls and dispenses the fluids therefrom to a patient <NUM>.

Main fluid system <NUM> includes a main fluid source such as a fluid bag <NUM> which may include or contain saline solution or other fluid to be administered to the patient. As illustrated, tube <NUM> carries flow from a drip chamber <NUM> to a Y-connector <NUM>. Check valve <NUM> is disposed in tube <NUM> upstream from the Y-connector <NUM> and enables flow from fluid bag <NUM> to the IV pump (not illustrated) while preventing reverse flow (backflow) of fluid from auxiliary fluid system <NUM> toward fluid bag <NUM>.

Auxiliary fluid system <NUM> includes an auxiliary fluid source such as a fluid bag <NUM>, which may contain drugs or other fluid to be supplied to the patient for treatment. An auxiliary fluid line <NUM> carries flow from drip chamber <NUM> to the Y-connector <NUM>.

The present disclosure relates generally to securement devices for stabilizing venous access devices, and, in particular, to a holder having an integrated adhesive backing for securing venous access devices such as intravenous needles and their associated luer fittings to a patient's skin.

<FIG> is a perspective view of a holder <NUM> for securing a venous access device, in accordance with some embodiments of the present disclosure. <FIG> is a front view of the holder of <FIG>, in accordance with some embodiments of the present disclosure. Referring to <FIG>, the holder <NUM> includes a flexible substrate <NUM> having an upper surface <NUM>, a lower surface <NUM>, and an outer perimetal surface <NUM>. In some embodiments, the flexible substrate <NUM> may be formed of a urethane or similar material which is flexible, clear, breathable and sterilizable to minimize contamination when the IV holder <NUM> is applied to the patient's skin. In some embodiments, the flexible substrate <NUM> may be formed of or include at least one of foam, silicone, soft plastic, rubber or elastomers.

As illustrated in <FIG>, an adhesive layer or backing <NUM> overlays the lower surface <NUM> of the flexible substrate <NUM>. In some embodiments, the adhesive layer or backing <NUM> may be adhered, fastened or otherwise attached to the lower surface <NUM> of the flexible substrate <NUM>. However, the various embodiments of the present disclosure are not limited to the aforementioned configuration. In some embodiments, the adhesive layer or backing <NUM> may be in the form of a coating, for example, an adhesive coated onto the lower surface <NUM> of the flexible substrate <NUM>. The adhesive layer or backing <NUM> may include an adhesive for adhering the holder <NUM> having an intravenous needle assembly and associated connector (e.g., Luer fitting) to skin of the patient <NUM>.

<FIG> is a bottom view of the holder of <FIG>, in accordance with some embodiments of the present disclosure. A hydrophilic matrix <NUM> is integrated into at least a portion of the adhesive layer or backing <NUM>. As depicted, the hydrophilic matrix <NUM> is integrated throughout the adhesive layer or backing <NUM>. However, the various embodiments of the present disclosure are not limited to the aforementioned configuration. In some embodiments, the hydrophilic matrix <NUM> may be integrated into only a portion of the adhesive layer or backing <NUM>.

<FIG> is a top view of the holder of <FIG>, in accordance with some embodiments of the present disclosure. <FIG> is a bottom view of the holder connector of <FIG>, in accordance with some embodiments of the present disclosure. The holder <NUM> includes at least one solvent reservoir <NUM> disposed on the upper surface <NUM> of the flexible substrate <NUM>. As depicted, two solvent reservoirs <NUM> may be disposed on the upper surface <NUM>. The various embodiments of the present disclosure however are not limited to the aforementioned configuration. In some embodiments, the holder may include only one solvent reservoir. In yet other embodiments, the holder <NUM> may include more than two solvent reservoirs <NUM>. The solvent reservoirs may be a cylindrical body configured with a hollow interior for containing a solvent therein. Although the solvent reservoirs <NUM> are depicted as being cylindrical in shape, the various embodiments of the present disclosure are not limited to this configuration. In other embodiments, the solvent reservoirs <NUM> may be of any shape such as circular, rectangular or other polygonal shapes. The solvent reservoirs <NUM> may contain a solvent capable of breaking down or otherwise dissolving the adhesive in the adhesive layer or backing <NUM> when the solvent is absorbed into the hydrophilic matrix, as shall be described in further detail below. In some embodiments, the solvent may be isopropyl alcohol.

In some embodiments, the at least one solvent reservoir <NUM> may have a hollow interior which is fluidly communicated with the hydrophilic matrix <NUM> that is integrated into the adhesive layer or backing <NUM>. For example, the flexible substrate <NUM> may include a cut-out or longitudinally extending aperture at a position corresponding to the position of each solvent reservoir <NUM>. Accordingly, solvent contained in the solvent reservoirs <NUM> may flow and be absorbed into the hydrophilic matrix <NUM> of the adhesive layer or backing <NUM>. Prior to removal of the holder <NUM> from a patient's skin, a barrier <NUM> having a shape and size corresponding to the aperture which fluidly communicates the solvent reservoirs <NUM> and the adhesive layer or backing <NUM>, may be interposed between the solvent reservoirs <NUM> and the adhesive layer or backing <NUM> in order to close or otherwise block the aperture. Accordingly, fluid communication between the solvent reservoirs <NUM> and the adhesive layer or backing <NUM> may be blocked until a time that it is desired to remove the holder <NUM> from the patient's skin. The barrier <NUM> may thus act or serve as a removable base of the solvent reservoirs <NUM>, which is removable in order to expose the solvent to the adhesive layer or backing <NUM>.

The holder <NUM> further includes a connector <NUM> secured to the outer perimetal surface <NUM> of the flexible substrate. The connector <NUM> may have a first end <NUM> for connection to a needle assembly (e.g., a catheter) and a second end <NUM> for connection to an IV fluid line (e.g. IV supply line <NUM>). For example, the connector <NUM> may be a luer lock fitting, and in particular may be, but not limited to, a male luer lock fitting. In these embodiments, the first end <NUM> of the male luer lock fitting may have a spin lock collar <NUM> for threaded engagement and connection of a needle assembly (e.g., catheter or other needle device) to be inserted into the body of the patient through the skin. Accordingly, a needle assembly may be attached or adhered to the patient's skin via the holder <NUM>. The aforementioned configuration is advantageous over prior art dressings and adhesive methods (e.g., taping) of needles and needle assemblies which directly adhere the needle assembly and associated connector (e.g., male luer lock fitting) to the patient's skin. For example, by incorporating the securement mechanism in the male luer lock fitting (i.e., by connecting the needle assembly to the holder <NUM> via the luer lock fitting <NUM> and then attaching the holder <NUM> to the patient), further isolation may be provided in cases where the needle assembly that is being used contains a short extension tube. Given the aforementioned configuration of the holder <NUM>, the short extension tube may filter out small dynamic loads and thereby not impart these loads onto the needle assembly that is inserted into the patient.

While not strictly necessary, there may be a benefit to be obtained if the holder <NUM> is longer (i.e., in the Y direction) than it is wide (i.e., in the X direction). A narrower width may provide for better support and securement of the holder <NUM>. Additionally, a longer length may allow for added versatility in the positioning of the holder <NUM> relative to the luer lock fitting <NUM>.

In operation, a needle assembly (e.g., a catheter or other needle device to be inserted into the body of a patient) may be threadedly engaged to the first end <NUM> of the luer lock fitting <NUM> via the spin lock collar <NUM>. The lower surface <NUM> of holder <NUM> may then be pressed against the skin of the patient to expose and adhere the adhesive layer or backing <NUM> to the patient's skin. Accordingly, the needle assembly may be securely attached or adhered to the patient's skin via the holder <NUM>. The IV supply line <NUM> may then be connected to the second end <NUM> of the luer lock fitting <NUM> in order to deliver a fluid or other drug from the IV supply line <NUM> to the patient via the needle assembly. Once the fluid has been administered to and/or removed from the patient's body via the needle assembly, the holder <NUM> may be detached from the patient's skin as detailed below.

In the event that it is necessary to detach the needle assembly from the luer lock fitting <NUM> for service and/or to clear a needle of the needle assembly, the luer lock fitting <NUM> may be unthreaded from the needle assembly via the spin lock collar <NUM>.

When it is desired to remove the holder <NUM> from the patient's skin, the barrier <NUM> may be removed thereby opening fluid connection between the solvent chambers <NUM> and the adhesive layer or backing <NUM>. Accordingly, the solvent may flow from the solvent chambers <NUM> into the adhesive layer or backing <NUM>. In particular, the solvent may flow into and be absorbed throughout the hydrophilic matrix <NUM> in the adhesive layer or backing <NUM>. The solvent may then begin to dissolve the adhesive of the adhesive layer or backing <NUM> which bonds the luer lock fitting <NUM> to the patient's skin. Since the solvent dissolves and breaks down the adhesive, the clinician or other user may advantageously be able to remove the male luer lock fitting from the patient's skin without causing damage or pain. Further advantageously, by incorporating means for removal of the adhesives as described above, a wider selection of adhesives may be available for use potentially leading to a securement architecture which is improved over current securement devices. For example, the aforementioned method of detaching the holder from the patient's skin may allow a stronger adhesive to be used without risk or hurting or damaging the patient's skin as may be the case with conventional securement methods. Furthermore, the adhesive layer or backing <NUM> provides a securement method, which further reduces the risk of needle assembly (e.g., catheter or other needle device) dislodgment.

<FIG> is a perspective top view of a holder <NUM> for securing a venous access device, in accordance with some embodiments of the present disclosure. <FIG> is a bottom view of the holder <NUM> of <FIG>, in accordance with some embodiments of the present disclosure. Referring to <FIG>, the holder <NUM> may include a flexible substrate <NUM> having an upper surface <NUM>, and a lower surface <NUM>. In some embodiments, the flexible substrate <NUM> may be formed of a urethane or similar material, which is flexible, clear, breathable and sterilizable to minimize contamination when the IV holder <NUM> is applied to the patient's skin. In some embodiments, the flexible substrate <NUM> may be formed of or include at least one of foam, silicone, soft plastic, rubber or elastomers.

As illustrated in <FIG>, an adhesive layer or backing <NUM> may overlay the lower surface <NUM> of the flexible substrate <NUM>. In some embodiments, the adhesive layer or backing <NUM> may be adhered, fastened or otherwise attached to the lower surface <NUM> of the flexible substrate <NUM>. However, the various embodiments of the present disclosure are not limited to the aforementioned configuration. In some embodiments, the adhesive layer or backing <NUM> may be in the form of a coating, for example, an adhesive coated onto the lower surface <NUM> of the flexible substrate <NUM>. The adhesive layer or backing <NUM> may include an adhesive for adhering the holder <NUM> having an intravenous needle assembly and associated connector (e.g., Luer fitting) to skin of the patient <NUM>.

In some embodiments, a solvent pathway <NUM> may be integrated into at least a portion of the adhesive layer or backing <NUM>. As depicted, the solvent pathway <NUM> is integrated throughout the adhesive layer or backing <NUM>. However, the various embodiments of the present disclosure are not limited to the aforementioned configuration. In some embodiments, the solvent pathway <NUM> may be integrated into only a portion of the adhesive layer or backing <NUM>.

The holder <NUM> may include at least one solvent delivery line <NUM> coupled to the upper surface <NUM> of the flexible substrate <NUM>. As depicted, one solvent delivery line <NUM> may be coupled to the upper surface <NUM>. The various embodiments of the present disclosure however are not limited to the aforementioned configuration. In some embodiments, the holder <NUM> may include more than one solvent delivery line <NUM>. The solvent delivery line <NUM> may be configured to transport a solvent from a solvent source (e.g., a syringe) into the solvent pathway <NUM>. Accordingly, the solvent pathway <NUM> may include at least one aperture <NUM> for fluidly connecting the solvent delivery line <NUM> and the solvent pathway <NUM>. As depicted, the solvent pathway <NUM> includes one aperture <NUM>. However, the various embodiments of the present disclosure are not limited to the aforementioned configuration. In some embodiments, the solvent pathway <NUM> may include more than one aperture <NUM>. As depicted, the solvent delivery line <NUM> may have a hollow interior which is fluidly communicated with the solvent pathway <NUM> that is integrated into the adhesive layer or backing <NUM>. Accordingly, the solvent delivery line <NUM> may be a vessel for transporting solvent from the solvent source (e.g., syringe) into the solvent pathway <NUM> of adhesive layer or backing <NUM> via the aperture <NUM>. The solvent pathway may be interposed between the patient's skin and the adhesive layer or backing <NUM> when the holder <NUM> is adhered to the patient's skin. The solvent may be capable of breaking down or otherwise dissolving the adhesive in the adhesive layer or backing <NUM> when the solvent is absorbed into the solvent pathway <NUM>, as shall be described in further detail below. In some embodiments, the solvent may be isopropyl alcohol.

According to various embodiments of the present disclosure, the solvent delivery line may have a first end <NUM> with a syringe connection portion <NUM> and a second end <NUM> coupled to the at least one aperture <NUM>. As depicted, the syringe connection portion <NUM> may be formed as a housing adapted to receive a syringe containing the solvent configured to dissolve and break down at least a portion of the adhesive layer or backing <NUM>.

According to various aspects of the present disclosure, the holder <NUM> may further include a connector <NUM> secured to the upper surface <NUM> of the flexible substrate <NUM>. The connector <NUM> may have a first end <NUM> for connection to a needle assembly (e.g., a catheter) and a second end <NUM> for connection to an IV fluid line (e.g., IV supply line <NUM>). For example, the connector <NUM> may be a luer lock fitting, and in particular may be, but not limited to, a male luer lock fitting. In these embodiments, the first end <NUM> of the male luer lock fitting may have a spin lock collar <NUM> for threaded engagement and connection of a needle assembly (e.g., catheter or other needle device) to be inserted into the body of the patient <NUM> through the skin. Accordingly, a needle assembly may be attached or adhered to the patient's skin via the holder <NUM>. The aforementioned configuration is advantageous over prior art dressings and adhesive methods (e.g., taping) of needles and needle assemblies which directly adhere the needle assembly and associated connector (e.g., male luer lock fitting) to the patient's skin. For example, by incorporating the securement mechanism in the male luer lock fitting (i.e., by connecting the needle assembly to the holder <NUM> via the luer lock fitting <NUM> and then attaching the holder <NUM> to the patient), further isolation may be provided in cases where the needle assembly that is being used contains a short extension tube. Given the aforementioned configuration of the holder <NUM>, the short extension tube may filter out small dynamic loads and thereby not impart these loads onto the needle assembly that is inserted into the patient.

In operation, a needle assembly (e.g., a catheter or other needle device to be inserted into the body of a patient) may be threadedly engaged to the first end <NUM> of the luer lock fitting <NUM> via the spin lock collar <NUM>. The lower surface <NUM> of holder <NUM> may then be pressed against the skin of the patient to expose and adhere the adhesive layer or backing <NUM> to the patient's skin. Accordingly, the needle assembly may be securely attached or adhered to the patient's skin via the holder <NUM>. The IV supply line <NUM> may then be connected to the second end <NUM> of the luer lock fitting <NUM> in order to deliver a fluid or other drug from the IV supply line <NUM> to the patient via the needle assembly. Once the fluid has been administered to and/or removed from the patient's body via the needle assembly, the holder <NUM> may be detached from the patient's skin as detailed below. In the event that it is necessary to detach the needle assembly from the luer lock fitting <NUM> for service and/or to clear a needle of the needle assembly, the luer lock fitting <NUM> may be unthreaded from the needle assembly via the spin lock collar <NUM>.

When it is desired to remove the holder <NUM> from the patient's skin, a syringe containing the solvent may be connected or otherwise attached to the syringe connection portion <NUM>. The solvent may then be injected from the syringe into the solvent delivery line <NUM> and transported to the solvent pathway <NUM> via the aperture <NUM>. Accordingly, the solvent may flow from the solvent pathway <NUM> into the adhesive layer or backing <NUM>. In particular, the solvent may flow into and be absorbed throughout the legs <NUM> and <NUM> of the solvent pathway <NUM>. The solvent may then begin to dissolve the adhesive of the adhesive layer or backing <NUM>, which bonds the luer lock fitting <NUM> to the patient's skin. As the solvent is delivered into the solvent pathway <NUM>, the flexible substrate <NUM> may balloon or otherwise expand, allowing the solvent to reach further parts of the adhesive layer or backing <NUM> and gently dissolve & peel away the adhesive layer or backing <NUM> throughout the holder <NUM>.

Since the solvent dissolves and breaks down the adhesive and causes the lower surface of the flexible substrate <NUM> to balloon and peel away from the patient's skin, the clinician or other user may advantageously be able to remove the male luer lock fitting <NUM> from the patient's skin without causing damage or pain. Further advantageously, the aforementioned method of detaching the holder <NUM> from the patient's skin may allow a stronger adhesive to be used without risk or hurting or damaging the patient's skin as may be the case with conventional securement methods. Furthermore, the adhesive layer or backing <NUM> provides a securement method which further reduces the risk of needle assembly (e.g., catheter or other needle device) dislodgment.

It is understood that the specific order or hierarchy of steps, or operations in the processes or methods disclosed are illustrations of exemplary approaches. Based upon implementation preferences or scenarios, it is understood that the specific order or hierarchy of steps, operations or processes may be rearranged. Some of the steps, operations or processes may be performed simultaneously. In some implementation preferences or scenarios, certain operations may or may not be performed. Some or all of the steps, operations, or processes may be performed automatically, without the intervention of a user. The accompanying method claims present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

Furthermore, to the extent that the term "include," "have," or the like is used, such term is intended to be inclusive in a manner similar to the term "comprise" as "comprise" is interpreted when employed as a transitional word in a claim.

Claim 1:
A holder (<NUM>, <NUM>) for securing a venous access device to a patient, the holder comprising:
a flexible substrate (<NUM>, <NUM>) having an upper surface (<NUM>, <NUM>), a lower surface (<NUM>, <NUM>), and an outer perimetal surface (<NUM>);
an adhesive layer (<NUM>, <NUM>) overlaying the lower surface (<NUM>, <NUM>) of the flexible substrate, the adhesive layer (<NUM>, <NUM>) having an adhesive for adhering to skin of the patient;
a hydrophilic matrix (<NUM>) integrated into at least a portion of the adhesive layer (<NUM>, <NUM>);
at least one solvent reservoir (<NUM>) disposed on the upper surface (<NUM>, <NUM>) of the flexible substrate; and
a connector (<NUM>) secured to the outer perimetal surface (<NUM>), the connector comprising a first end (<NUM>) for connection to a needle assembly and a second end (<NUM>) for connection to an IV fluid line.