Self-activating catheter insertion site dressing

A self-activating dressing impregnated with a nitric oxide-releasing compound addresses CRBSIs by providing broad-spectrum antimicrobial protection and wound healing, effectively reducing infection risks and promoting healing at catheter insertion sites.

JP7748953B2Active Publication Date: 2025-10-03BECTON DICKINSON & CO
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Patent Information

Application Number
JP2022546058
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2021-01-07
Filing Date
2021-01-14
Publication Date
2025-10-03
Estimated Expiration
2041-01-14

AI Technical Summary

Technical Problem

Catheter-related bloodstream infections (CRBSIs) are a significant healthcare challenge due to bacterial colonization at the insertion site, leading to substantial illness and medical costs, despite existing antimicrobial dressings, there is a need for a self-activating dressing that provides broad-spectrum antimicrobial activity and promotes wound healing.

Method used

A self-activating dressing impregnated with a nitric oxide-releasing compound that reacts with physiological fluids to release nitric oxide, offering antimicrobial protection and wound healing, incorporating catalysts and additional antibacterial agents for enhanced efficacy.

Benefits of technology

The dressing effectively prevents microbial colonization and promotes wound healing by releasing nitric oxide, synergizing with common antimicrobial agents, thereby reducing the risk of CRBSIs and enhancing healing at catheter insertion sites.

✦ Generated by Eureka AI based on patent content.

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Abstract

A self-activating bandage for use with a medical device inserted into a patient's skin surface through a skin insertion site. The bandage includes a bandage body impregnated with a nitric oxide-releasing compound that reacts in the presence of physiological fluids to release nitric oxide. The nitric oxide provides antimicrobial activity and promotes wound healing. The nitric oxide-releasing compound may include s-nitroso-n-acetylpenicillamine (SNAP), s-nitrosoglutathione (GSNO), and mixtures thereof. A slit defined in the bandage body allows the bandage body to be placed around the medical device on the skin surface at the skin insertion site so that the bandage body surrounds and contacts the skin insertion site. The bandage body may be further impregnated with a catalyst, such as copper, iron, zinc, selenium, or silver, to facilitate the release of nitric oxide. The bandage body may also be further impregnated with an additional antimicrobial agent.
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Description

[Technical Field]

[0001] The present invention relates to a self-activating bandage. [Background technology]

[0002] The present disclosure relates to catheter insertion site dressings impregnated with nitric oxide precursors that are activated in the presence of physiological fluids to release nitric oxide, which provides antimicrobial activity and promotes wound healing.

[0003] Catheters are commonly used for various infusion therapies. Infusion therapy is one of the most common medical procedures. Hospitalized, home health, and other patients receive fluids, medications, and blood products through vascular access devices inserted into their vascular systems. Infusion therapy may be used to treat infections, provide anesthesia or analgesia, provide nutritional support, treat cancer growths, maintain blood pressure and cardiac rhythm, or for many other clinically important applications. For example, catheters are used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into patients, withdraw blood from patients, and monitor various parameters of the patient's vascular system.

[0004] Catheters are typically introduced into a patient's vascular system as part of an intravenous catheter assembly. The catheter assembly generally includes a catheter hub that supports the catheter, which is coupled to a needle hub that supports an introducer needle. The introducer needle extends and is positioned within the catheter such that a beveled portion of the needle is exposed beyond the tip of the catheter. The beveled portion of the needle is used to pierce the patient's skin and provide an opening thereby for inserting the needle into the patient's vascular system. After insertion and placement of the catheter, the introducer needle is removed from the catheter, thereby providing intravenous access to the patient.

[0005] Catheter use causes skin breakdown, which provides an access point for pathogens to enter the body, putting patients at risk for local and systemic infectious complications. The likelihood of infection can be increased by bacterial proliferation within or beneath the dressing at the catheter insertion site. Skin flora is a major source of microbial contamination and is responsible for approximately 65% ​​of catheter-related infections. Bacteria from the skin migrate along the catheter's exterior and colonize the catheter tip within the blood vessels, leading to catheter-related bloodstream infections. Catheter-related bloodstream infections (CRBSIs) are the third most common healthcare-acquired infection in the United States and are considered one of the most dangerous complications for patients. These infections are a significant cause of illness and excessive medical costs, with approximately 250,000 to 400,000 central venous catheter (CVC)-related bloodstream infections occurring annually in U.S. hospitals. In addition to the financial cost, these infections are associated with 20,000 to 100,000 deaths annually. Despite existing guidelines to reduce healthcare-associated infections (HAIs), catheter-related bloodstream infections continue to plague our healthcare system. Most of the microorganisms that cause CRBSI originate at the catheter insertion site, so reducing bacterial colonization at the insertion site may help reduce the incidence of CRBSI.

[0006] Although antimicrobial dressings are known for use with catheters and other percutaneous medical devices at insertion sites, there remains a need for a catheter insertion site dressing that provides broad spectrum antimicrobial activity and is self-activating to promote wound healing at the insertion site.

[0007] The subject matter disclosed and claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments. Rather, this background is only provided to illustrate one example technology area where some embodiments described herein may be practiced. Summary of the Invention

[0008] The present disclosure generally relates to a self-activating dressing for use with a medical device inserted into a patient's skin surface at a dermal insertion site. The dressing body is impregnated with a nitric oxide-releasing compound that reacts in the presence of physiological fluids to release nitric oxide, providing antimicrobial activity and wound healing. The dressing body includes a slit configured to allow the dressing body to be positioned around the medical device on the skin surface at the dermal insertion site so that the dressing body surrounds and contacts the dermal insertion site.

[0009] Nitric oxide is a broad-spectrum antimicrobial and homeostasis agent effective for prophylactic and therapeutic applications. Nitric oxide released from insertion site dressings promotes healing and antimicrobial protection. In addition, nitric oxide has synergistic properties with common antimicrobial agents, such as chlorhexidine or silver, to enhance function. One or more nitric oxide-releasing compounds are incorporated into self-activating antimicrobial insertion site dressings, which release nitric oxide in the presence of physiological fluids. Non-limiting examples of physiological fluids include sweat, interstitial fluid, and blood.

[0010] Any physiologically compatible nitric oxide-releasing compound may be used herein. Non-limiting examples of nitric oxide-releasing compounds include s-nitroso-n-acetylpenicillamine (SNAP), s-nitrosoglutathione (GSNO), and mixtures thereof. The nitric oxide-releasing compound is impregnated into the dressing body.

[0011] The impregnation step can be accomplished by exposing the bandage body to a solvent having the nitric oxide-releasing compound dissolved therein. The bandage body is exposed to the solvent solution for a time sufficient to allow the nitric oxide-releasing compound to penetrate the bandage body. The impregnation step can be performed at room temperature. The impregnation step can occur at a temperature ranging from about 25 to 55°C. Any solvent compatible with the nitric oxide-releasing compound and the bandage body can be used. The nitric oxide-releasing compound can be dissolved in tetrahydrofuran (THF), dioxolane, methyl ethyl ketone (MEK), methanol, ethanol, isopropyl alcohol, water, or a combination thereof. The bandage can be immersed in these solutions containing the nitric oxide-releasing compound for a sufficient time to impregnate the bandage with the nitric oxide-releasing compound. The exposure time can be between 5 minutes and 24 hours.

[0012] The bandage body may be further impregnated with a catalyst to facilitate the release of nitric oxide. Non-limiting examples of such catalysts include copper, iron, zinc, selenium, and silver. The catalyst may be impregnated into the bandage body by exposing the bandage body to a solvent having the catalyst dissolved therein. The catalyst may be impregnated into the bandage body using the same solvent system as the nitric oxide-releasing compound described above, either during the same impregnation step, a subsequent impregnation step, or a previous impregnation step. The bandage body is exposed to the solvent solution for a time sufficient to allow the catalyst to penetrate the bandage body. The impregnation step may be performed at room temperature. The impregnation step may occur at a temperature ranging from about 25 to 55°C. Any solvent compatible with the catalyst and the bandage body may be used, including those described above for the nitric oxide-releasing compound.

[0013] The dressing body may be further impregnated with an additional antibacterial agent. Non-limiting examples of additional antibacterial agents include chlorhexidine diacetate, chlorhexidine base, chlorhexidine gluconate, and mixtures thereof. Further non-limiting examples of additional antibacterial agents include silver, silver-sulfadiazine, and mixtures thereof. Other non-limiting examples of additional antibacterial agents include ethyl violet, gentian violet, methylene blue, and mixtures thereof. The additional antibacterial agent may be impregnated into the dressing body by exposing the dressing body to a solvent having the additional antibacterial agent dissolved therein. The additional antibacterial agent may be impregnated into the dressing body using the same solvent system as the nitric oxide-releasing compound described above, either during the same impregnation step, a subsequent impregnation step, or a previous impregnation step. The dressing body is exposed to the solvent solution for a time sufficient to allow the additional antibacterial agent to penetrate the dressing body. The impregnation step may be performed at room temperature. The impregnation step may occur at a temperature ranging from about 25 to 55°C. Any solvent compatible with the additional antimicrobial agent and the dressing body may be used, including those described above with respect to the nitric oxide-releasing compound.

[0014] The bandage body can be made of any physiologically compatible material that can be impregnated with a nitric oxide-releasing compound and release nitric oxide. The bandage body material also functions as a dressing for the insertion site of the medical device. The bandage body material can also be impregnated with a catalyst and additional antimicrobial agents. Non-limiting examples of suitable bandage body materials include oxidized cellulose foam, collagen fibrils, and alginate hydrogel.

[0015] The bandage body can have any geometric shape. In one preferred embodiment, the bandage body is substantially disc-shaped. Other non-limiting geometric shapes for the bandage body include oval, triangle, square, rectangle, pentagon, hexagon, octagon, and the like. The bandage body can include a central opening for receipt of a medical device. The central opening can have a diameter ranging from 0.04 inches to 0.3 inches. The bandage body can have an outer dimension or diameter ranging from 0.5 inches to 3 inches. The bandage body can have a thickness ranging from 0.03 inches to 0.2 inches.

[0016] The self-activating bandage is particularly adapted for use with a medical device inserted into the patient's skin surface via a skin insertion site. The medical device may be a catheter.

[0017] Various embodiments are listed below. It will be understood that the embodiments listed below may be combined in other suitable combinations in accordance with the scope of the present invention, not just those listed below.

[0018] In one aspect, a self-activating bandage for use with a medical device inserted into a patient's skin surface through a skin insertion site includes a bandage body impregnated with a nitric oxide-releasing compound that reacts in the presence of physiological fluid to release nitric oxide, and a slit defined in the body to allow the body to be positioned around the medical device on the skin surface at the skin insertion site so that the bandage body surrounds and contacts the skin insertion site.

[0019] In one or more embodiments, the nitric oxide-releasing compound impregnated into the dressing body may be selected from s-nitroso-n-acetylpenicillamine (SNAP), s-nitrosoglutathione (GSNO), and mixtures thereof.

[0020] In one or more embodiments, the physiological fluid may be selected from sweat, interstitial fluid, and blood.

[0021] In any embodiment herein, the dressing body may be further impregnated with a catalyst to facilitate the release of nitric oxide. The catalyst may be selected from copper, iron, zinc, selenium, and silver.

[0022] In any embodiment herein, the dressing body may be further impregnated with an additional antibacterial agent. The additional antibacterial agent may be selected from chlorhexidine diacetate, chlorhexidine base, chlorhexidine gluconate, and mixtures thereof. The additional antibacterial agent may be selected from silver, silver-sulfadiazine, and mixtures thereof. The additional antibacterial agent may be selected from ethyl violet, gentian violet, methylene blue, and mixtures thereof.

[0023] In any embodiment herein, the bandage body may comprise oxidized cellulose foam. In any embodiment herein, the bandage body may comprise collagen fibrils. In any embodiment herein, the bandage body may comprise alginate hydrogel.

[0024] In any embodiment herein, the bandage body may be substantially disc-shaped. In any embodiment herein, the bandage body may include a central opening for receiving a medical device. The central opening may have a diameter ranging from 0.04 inches to 0.3 inches. In any embodiment herein, the bandage body may include a slit extending from the central opening to the outer periphery of the bandage body.

[0025] In any embodiment herein, the bandage body may have an outer diameter ranging from 0.5 inches to 3 inches. In any embodiment herein, the bandage body may have a thickness ranging from 0.03 inches to 0.2 inches.

[0026] In any embodiment herein, the medical device may be a percutaneous device such as a catheter.

[0027] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed invention. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. It is also to be understood that embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief explanation of the drawings]

[0028] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1] FIG. 1 is a perspective view of an insertion site dressing, according to some embodiments. [Figure 2] FIG. 2 is a close-up perspective view of an insertion site dressing, according to some embodiments. [Figure 3] FIG. 3 is a perspective view of an insertion site dressing placed around a medical device on a patient's skin surface, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0029] The present disclosure relates to a self-activating antimicrobial catheter insertion site dressing impregnated with a nitric oxide (NO)-releasing compound that is activated in the presence of physiological fluids to release nitric oxide, which exhibits potent broad-spectrum antimicrobial properties and promotes wound healing at the insertion site.

[0030] Nitric oxide is a natural antibacterial agent. It reacts with physiological concentrations of superoxide to induce oxidative stress, nitrifying amino acids in bacterial cells (nitrosates), oxidizing and destroying their DNA strands, and producing peroxynitrite, which causes cell membrane damage via lipid peroxidation. In addition, nitric oxide reacts with oxidizing agents to form N2O3, which reacts with sulfhydryl groups of cysteine ​​residues on bacterial membrane proteins, altering or inhibiting their function.

[0031] By incorporating a nitric oxide-releasing compound into the insertion site dressing, the nitric oxide-releasing compound reacts and decomposes in the presence of physiological fluids such as sweat, interstitial fluid, or blood, releasing nitric oxide in the gas phase at physiologically relevant levels to exert the physiological mechanisms described above at the insertion site. Additionally, nitric oxide has synergistic properties with common antimicrobial agents such as chlorhexidine or silver to enhance function.

[0032] 1 and 2, which illustrate a self-activating antimicrobial insertion site bandage 10 for use with a medical device inserted into a patient's skin surface via a cutaneous insertion site. The bandage 10 includes a bandage body 12 impregnated with a nitric oxide-releasing compound that reacts in the presence of physiological fluids to release nitric oxide.

[0033] The bandage body 12 described herein may be of any suitable shape. In the embodiment shown in Figures 1 and 2, the bandage body 12 has a circular or disc shape. Other suitable shapes include, but are not limited to, oval, triangular, square, rectangular, hexagonal, octagonal, or any polygonal shape. One skilled in the art will understand how to modify the shape and size, including length, width, and / or diameter, of the devices of the present disclosure based on the intended use of the device and the expected results, including, but not limited to, the intended dosage and release profile of the nitric oxide-releasing compound and any other antimicrobial or bioactive agent.

[0034] One or more nitric oxide-releasing compounds are incorporated into the self-activating antimicrobial insertion site dressing 10 to release nitric oxide in the presence of physiological fluids. Any physiologically compatible nitric oxide-releasing compound may be used herein. Non-limiting examples of nitric oxide-releasing compounds include s-nitroso-n-acetylpenicillamine (SNAP), s-nitrosoglutathione (GSNO), and mixtures thereof.

[0035] The nitric oxide-releasing compound may be impregnated into the bandage body 12 by exposing the bandage body 12 to a solvent having the nitric oxide-releasing compound dissolved therein. The bandage body 12 is exposed to the solvent solution for a time sufficient to allow the nitric oxide-releasing compound to penetrate the bandage body 12. The impregnation process may occur at any suitable temperature. The impregnation process may occur at room temperature. The impregnation process may occur at a temperature ranging from about 25 to 55°C. Any solvent compatible with the nitric oxide-releasing compound and the bandage body may be used.

[0036] The nitric oxide-releasing compound may be dissolved in tetrahydrofuran (THF), dioxolane, methyl ethyl ketone (MEK), methanol, ethanol, isopropyl alcohol, water, or a combination thereof. The bandage may be immersed in these solutions containing the nitric oxide-releasing compound for a sufficient time to impregnate the bandage with the nitric oxide-releasing compound. The exposure time may be between 5 minutes and 24 hours.

[0037] The bandage body 12 may further be impregnated with a catalyst to facilitate the release of nitric oxide. Non-limiting examples of such catalysts include copper, iron, zinc, selenium, and silver. The catalyst may be impregnated into the bandage body 12 by exposing the bandage body 12 to a solvent having the catalyst dissolved therein. The catalyst may be impregnated into the bandage body using the same solvent system as the nitric oxide-releasing compound described above, either during the same impregnation step, a subsequent impregnation step, or a previous impregnation step. The bandage body is exposed to the solvent solution for a time sufficient to allow the catalyst to penetrate the bandage body. The impregnation step may occur at any suitable temperature. The impregnation step may be performed at room temperature. The impregnation step may occur at a temperature ranging from about 25 to 55°C. Any solvent compatible with the nitric oxide-releasing compound and the bandage body may be used.

[0038] The dressing body may be further impregnated with an additional antibacterial agent. Non-limiting examples of additional antibacterial agents include chlorhexidine diacetate, chlorhexidine base, chlorhexidine gluconate, and mixtures thereof. Further non-limiting examples of additional antibacterial agents include silver, silver-sulfadiazine, and mixtures thereof. Other non-limiting examples of additional antibacterial agents include ethyl violet, gentian violet, methylene blue, and mixtures thereof. The additional antibacterial agent may be impregnated into the dressing body by exposing the dressing body to a solvent having the additional antibacterial agent dissolved therein. The additional antibacterial agent may be impregnated into the dressing body using the same solvent system as the nitric oxide-releasing compound described above, either during the same impregnation step, a subsequent impregnation step, or a previous impregnation step. The dressing body is exposed to the solvent solution for a time sufficient to allow the additional antibacterial agent to penetrate the dressing body. The impregnation step may occur at any suitable temperature. The impregnation step may be performed at room temperature. The impregnation process may occur at a temperature ranging from about 25 to 55° C. Any solvent compatible with the nitric oxide-releasing compound and the dressing body may be used.

[0039] The dressing body 12 may be made of any physiologically compatible material that can be impregnated with a nitric oxide-releasing compound and release nitric oxide. Non-limiting examples of suitable dressing body materials include oxidized cellulose foam, collagen fibrils, and alginate hydrogel.

[0040] The bandage 10 described herein is configured for use with a percutaneous medical device, such as an indwelling catheter, which pierces a patient's skin and leaves a portion of the catheter protruding from the skin. The bandage body includes a slit 14 configured to allow the bandage body to be placed around the medical device on the skin surface at the skin insertion site so that the bandage body surrounds and contacts the skin insertion site. The slit 14 can be formed in the bandage body 12 by cutting, punching, or other similar mechanical forming techniques. The width of the slit 14 is adapted to facilitate placement over an already placed percutaneous medical device. The width of the slit can range from very small (i.e., cut with a very narrow blade) when the sides of the slit touch each other, to a slit corresponding to a gap of less than about 0.004 inches to a gap of about 0.04 inches. The slit 14 allows the bandage to completely surround the percutaneous medical device at the insertion or puncture site.

[0041] The bandage body 12 can have any geometric shape. In one preferred embodiment, the bandage body is substantially disc-shaped. Other non-limiting geometric shapes for the bandage body include oval, triangle, square, rectangle, pentagon, hexagon, octagon, etc.

[0042] The bandage body 12 may include a central opening 16 for receipt of a medical device. The size or diameter (D a ) is adapted to completely surround the medical device protruding from the insertion site in a snug or loose configuration and has an opening size or diameter (D aThe central opening typically ranges in size or diameter (D ) from about 90 percent of the outer diameter of the medical device to about 150 percent of the outer diameter of the medical device. The central opening ranges in size or diameter (D ) from 0.04 inches to 0.3 inches. a ) may be included.

[0043] The slit 14 extends from a central opening 16 to the outer periphery 18 of the dressing body.

[0044] The bandage body can have an outer size or diameter (D) ranging from 0.5 inches to 3 inches. b ).

[0045] The thickness (T) of the bandage body 12 can vary as desired depending on the desired pharmaceutical dosage of nitric oxide, any other antimicrobial or biologically active agents impregnated in the bandage body, and the delivery period. A suitable pad thickness is in the range of about 0.03 inches to 0.2 inches.

[0046] 3 is a perspective view of one exemplary use of bandage 10 positioned around a medical device on a patient's skin surface 20. Bandage 10 includes a bandage body 12 that covers a skin insertion site 22 through which a medical device, such as a catheter assembly 24, is passed for disposal within the patient's body.

[0047] 3, the catheter assembly 24 includes a catheter tube 26 and a hub 28 attached to the proximal end of the catheter tube 26. The catheter tube 26 extends through the skin surface into the patient via the skin insertion site 22.

[0048] Although the discussion herein focuses on the use of bandages with peripheral IV catheters, other types of catheters and medical devices can benefit from the use of bandages. Non-limiting examples of such catheters and medical devices include central venous catheters, peripheral venous catheters, or any other indwelling catheter for delivery to and / or sampling from a patient. All of these indwelling catheters, when in place, leave a portion of the catheter device outside and protruding from the skin, which can be a source of infection around the insertion site of the medical device.

[0049] An adhesive (not shown) may optionally be provided on the bottom surface of the bandage body 12 configured to adhere the bandage 10 to the patient's skin surface.

[0050] The slits 14 allow the bandage body 12 to completely surround and contact the skin entry site 22 through which the catheter tube 26 passes (or other medical device that passes through the skin). This prevents a portion of the area immediately surrounding the skin entry site 22 from being exposed. In response to physiological fluids, such as sweat, interstitial fluid, or blood, the nitric oxide-releasing compound within the bandage body releases nitric oxide to contact the skin surface at the skin entry site 22. In this manner, the bandage is self-activated in response to physiological fluids. The released nitric oxide prevents microbial colonization and promotes wound healing.

[0051] The dressing film 32 may optionally have an inner surface facing the patient's skin and an outer surface facing away from the patient's skin. The dressing film 32 can be formed from any physiologically compatible adhesive translucent or transparent dressing for wounds, such as a polyurethane film or a copolyester film. The film may have a thickness of approximately 50 to 350 microns, preferably 100 to 200 microns. Other suitable materials for the dressing film 32 include a transparent polyester film with a pressure-sensitive biocompatible adhesive. The pressure-sensitive adhesive may be disposed on the inner surface of the dressing film 32. The pressure-sensitive adhesive may be any pressure-sensitive adhesive known in the art. The adhesive may be continuous or discontinuous, i.e., applied in a patterned manner. In one embodiment, the adhesive is applied in stripes, thus providing breathability for the dressing. In another embodiment, adhesive is applied to the peripheral frame 34 of the bandage film and not to the bandage film surrounded by the peripheral frame 34, thereby creating an adhesive-free area over the bandage 10 and catheter assembly 24, which may facilitate removal of the bandage 10 during bandage changes.

[0052] In one embodiment, the dressing film 32 is at least partially translucent or transparent to allow a medical professional to visually inspect the dressing 10 and catheter assembly 24 .

[0053] The disclosed bandage 10, which releases nitric oxide at the insertion site of a medical device, provides hemostatic and wound healing activity. The bandage can control minor bleeding at percutaneous medical device insertion access sites. Additionally, the present disclosure promotes wound healing while providing protection at the insertion site through the slow release of nitric oxide, a broad-spectrum antimicrobial agent that helps resist microbial colonization of the bandage.

[0054] All examples and conditional language set forth herein are intended for educational purposes to aid in understanding the invention and concepts provided by the inventor to further the technology, and should be construed as not being limited to the specifically recited examples and conditions. Although embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

1. 1. A self-activating bandage for use with a medical device inserted into a patient's skin surface via a skin insertion site, comprising: a bandage body made from a material selected from oxidized cellulose foam or collagen fibrils and impregnated with a nitric oxide-releasing compound, the bandage body material releasing nitric oxide in response to physiological fluids; a slit formed in the bandage body configured to allow the bandage body to be placed around the medical device on the skin surface at the skin insertion site so that the material of the bandage body impregnated with a nitric oxide-releasing compound surrounds and contacts the skin insertion site around the medical device.

2. 2. The self-activating bandage of claim 1, wherein the nitric oxide-releasing compound impregnated in the bandage body is selected from s-nitroso-n-acetylpenicillamine (SNAP), s-nitrosoglutathione (GSNO), and mixtures thereof.

3. The self-activating bandage of claim 1 , wherein the physiological fluid is selected from sweat, interstitial fluid, and blood.

4. 10. The self-activating bandage of claim 1, wherein the bandage body is further impregnated with a catalyst to promote the release of nitric oxide.

5. 5. The self-activating bandage of claim 4, wherein the catalyst is selected from copper, iron, zinc, selenium, and silver.

6. The self-activating bandage of claim 1 , wherein the bandage body is further impregnated with an additional antimicrobial agent.

7. 7. The self-activating bandage of claim 6, wherein the additional antimicrobial agent is selected from chlorhexidine diacetate, chlorhexidine base, chlorhexidine gluconate, and mixtures thereof.

8. 7. The self-activating bandage of claim 6, wherein the additional antimicrobial agent is selected from silver, silver-sulfadiazine, and mixtures thereof.

9. 7. The self-activating bandage of claim 6, wherein the additional antimicrobial agent is selected from ethyl violet, gentian violet, methylene blue, and mixtures thereof.

10. The self-activating bandage of claim 1 , wherein the bandage body is substantially disc-shaped.

11. The self-activating bandage of claim 1 , wherein the bandage body includes a central opening for receipt of the medical device.

12. 12. The self-activating bandage of claim 11, wherein the central opening has a diameter in the range of 0.04 inches to 0.3 inches.

13. 10. The self-activating bandage of claim 1, wherein the bandage body has an outer diameter in the range of 0.5 inches to 3 inches.

14. 10. The self-activating bandage of claim 1, wherein the bandage body has a thickness in the range of 0.03 inches to 0.2 inches.

15. 11. The self-activating bandage of claim 10, wherein the bandage body includes a central opening for receipt of the medical device, the central opening having a diameter in the range of 0.04 inches to 0.3 inches, the bandage body having an outer diameter in the range of 0.5 inches to 3 inches, and the bandage body having a thickness in the range of 0.03 inches to 0.2 inches.

16. The self-activating bandage of claim 1 , wherein the medical device is a catheter.

17. 2. The self-activating bandage of claim 1, wherein the bandage body is made from oxidized cellulose foam, the nitric oxide-releasing compound impregnated into the bandage body is s-nitro-n-acetylpenicillamine (SNAP), the bandage body is further impregnated with silver sulfadiazine as an additional antibacterial agent, and the bandage body is further impregnated with a silver catalyst to promote the release of nitric oxide.

Citation Information

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