Medical devices with photosensitizers and related methods

Abstract

A medical device can include a body and a photosensitizer integrated with the body. The medical device can passively resist colonization by bacteria under ambient light. The medical device can also actively resist colonization by bacteria by releasing reactive oxygen species (ROS) in response to a light dose applied over a duration between 1 second and 1 hour ranging from 0.5 J / cm 2 to 320 J / cm 2 . The body can be formed from a base resin. The photosensitizer can be compounded with the base resin. The photosensitizer can be absorbed into the base resin. The medical device can include a coating disposed on a surface of the body. The photosensitizer can be disposed within the coating. The medical device can include a catheter adapter and a catheter extending distally from the catheter adapter. The catheter can be co-extruded with the photosensitizer and another material.

Description

Technical Field

[0001] This disclosure generally relates to medical devices and related methods that help to purify and promote antimicrobial resistance. Background Technology

[0002] There are different types of photosensitizers, each with a specific excitation wavelength. During photosensitization, excited electrons are raised to higher energy levels, and the photosensitizer reaches the first excited singlet state. The first excited singlet state decays to a lower energy level by emitting fluorescence or, alternatively, by intersystem crossing to a state called the triplet state. The triplet state has a long lifetime, and due to this property, it can react with triplet oxygen molecules and other biomolecules or emit phosphorescence. When a photosensitizer in the triplet state transfers energy to triplet oxygen, a highly reactive substance called singlet oxygen is produced. Both triplet photosensitizers and singlet oxygen are unstable molecules, and therefore, after photosensitizer irradiation, they can damage polyunsaturated lipids, nucleic acids, and proteins in biological tissues.

[0003] The direct reaction between a triplet photosensitizer and a biomolecule is called a type I reaction, and this process causes photosensitizer bleaching. The generation of singlet oxygen from a triplet photosensitizer is called a type II reaction, and it regenerates the ground-state photosensitizer. Although both type I and type II reactions damage cells, the damage induced by type II reactions is more severe than that induced by type I reactions.

[0004] Conventionally, catheters are used to infuse fluids (such as saline solutions, various medications, and / or total parenteral nutrition) into a patient. Such catheters can also be used to draw blood from a patient and / or monitor various parameters of a patient's vascular system. To introduce the catheter into the patient, a guide needle may be used, which may include a sharp distal tip. The catheter may include a sheathed peripheral venous (“IV”) catheter mounted on the guide needle. The inner surface of the catheter may tightly engage the outer surface of the guide needle to prevent catheter dislodgement and facilitate catheter insertion into a blood vessel. The sharp distal tip of the guide needle may extend beyond the distal tip of the catheter to allow the catheter to pass through the patient's skin at a small angle and be inserted into a blood vessel.

[0005] To verify proper placement of the needle and catheter in the blood vessel, clinicians can confirm the presence of a blood "flashback" in the flashback chamber associated with the catheter and needle assembly. Once proper placement is confirmed, the clinician can apply pressure to the blood vessel to occlude it, thereby reducing further blood flow through the guide needle and catheter. The clinician can then withdraw the needle from the catheter to establish a continuous pathway through the catheter into the blood vessel.

[0006] Catheters are susceptible to bacterial infection, which can infect and harm patients. Similarly, other vascular access devices, as well as ultrasound devices, dressings, pumps, and other medical devices located close to the patient, are also prone to bacterial infection, which can infect and harm patients. There is a need for materials that can enhance the antimicrobial resistance of medical devices.

[0007] The subject matter claimed in this disclosure is not limited to embodiments that address any shortcomings or operate only in environments such as those described above. Rather, this background is provided merely to illustrate an exemplary technical field in which some of the embodiments described in this disclosure can be practiced. Summary of the Invention

[0008] This disclosure generally relates to medical devices and related methods that facilitate purification and promotion of antimicrobial resistance. In some embodiments, the medical device may include a body and a photosensitizer integrated with the body. In some embodiments, the photosensitizer may include methylene blue, neomethylene blue, Nile blue, rose red, toluidine blue O, crystal violet, or another suitable photosensitizer. In some embodiments, the body may include a variety of photosensitizers integrated with the body.

[0009] The photosensitizer can be integrated with the host in various ways. For example, the host can be formed of a base resin, and the photosensitizer can be compounded with the base resin. In some embodiments, the base resin may include polyphenylsulfone, polyurethane, or silicone. In some embodiments, the concentration of the photosensitizer within the base resin may be between 0.05% and 5%.

[0010] As another example, the medical device may include a coating disposed on the surface of a body, and a photosensitizer may be disposed within the coating. In some embodiments, the concentration of the photosensitizer within the coating may be between 0.05% and 5%. As yet another example, the medical device may include a catheter adapter and a catheter extending distally from the catheter adapter. In these embodiments, the catheter may be co-extruded with the photosensitizer and another material. As yet another example, the body may be formed from a base resin, and the photosensitizer is absorbed into the base resin.

[0011] In some embodiments, the medical device may include a needle-free connector or cap. In some embodiments, the medical device may include an ultrasound transducer. In some embodiments, the medical device may include a dressing, surgical mesh, a pump, or another suitable medical device.

[0012] In some embodiments, a method for sterilizing a medical device may include providing the medical device. In some embodiments, the method may include applying a photosensitizer integrated with the body in the range of 0.5 J / cm². 2 and 320J / cm 2The light dose is between [a certain value]. In some embodiments, the light dose may be applied over a duration between 1 second and 1 hour.

[0013] In some embodiments, the method may include integrating a photosensitizer with the body of a medical device. In some embodiments, integrating a photosensitizer with the body of a medical device may include compounding the photosensitizer with a base resin. In some embodiments, integrating a photosensitizer with the body of a medical device may include applying a coating to the surface of the medical device. In some embodiments, the medical device may include a catheter adapter and a catheter, and integrating a photosensitizer with the body of the medical device may include co-extruding the catheter along with the photosensitizer and another material. In some embodiments, integrating a photosensitizer with the body of a medical device may include absorbing the photosensitizer into a base resin.

[0014] It should be understood that the foregoing general description and the following detailed description are exemplary and illustrative, and do not limit the scope of the claimed disclosure. It should be understood that the various embodiments are not limited to the settings and means shown in the accompanying drawings. It should also be understood that these embodiments may be combined, other embodiments may be utilized, and structural changes may be made (unless required) without departing from the scope of the various embodiments of this disclosure. Therefore, the following detailed description should not be considered limiting. Attached Figure Description

[0015] The exemplary embodiments will be described and illustrated in a more specific and detailed manner using the accompanying drawings, wherein:

[0016] Figure 1A This is a top perspective view of an example medical device according to some embodiments;

[0017] Figure 1B According to some embodiments Figure 1A A cross-sectional view of a medical device, showing an example coating;

[0018] Figure 2 This is a top perspective view of another example medical device according to some embodiments;

[0019] Figure 3 This is a top perspective view of another example medical device according to some embodiments;

[0020] Figure 4 This is a top perspective view of another example medical device according to some embodiments;

[0021] Figure 5A This is a top perspective view of another example medical device according to some embodiments;

[0022] Figure 5B According to some embodiments Figure 5A An enlarged top perspective view of the medical device; and

[0023] Figure 6 This is a schematic diagram of an example chamber for providing light dose to a medical device according to some embodiments. Detailed Implementation

[0024] Now for reference Figure 1A The figure illustrates a medical device 10. As shown, for example, in Figure 1, the medical device 10 may include an ultrasound transducer. In other embodiments, the medical device 10 may include a catheter, catheter adapter, connector, cap, ultrasound transducer, dressing, surgical mesh, pump, or another suitable medical device that comes into contact with or is in close proximity to the patient.

[0025] In some embodiments, the medical device 10 may include a body 12 and a photosensitizer integrated with the body 12. In some embodiments, the body 12 may include any part of the medical device 10 that contacts or is located near the patient. In some embodiments, the medical device 10 may include an ultrasound transducer, and the body 12 may include a distal end 14 of the ultrasound transducer. In some embodiments, the photosensitizer may include methylene blue, neomethylene blue, Nile blue, rose red, toluidine blue O, crystal violet, or another suitable photosensitizer.

[0026] In some embodiments, the photosensitizer may be integrated with the body 12 in various ways. In some embodiments, the body 12 may be formed of a base resin, and the photosensitizer may be compounded with the base resin. In some embodiments, the base resin may include polyphenylsulfone, polyurethane, silicone, or another suitable base resin. In some embodiments, the concentration of the photosensitizer within the base resin may be between 0.05% and 5%.

[0027] In some embodiments, the body 12 may be formed of a base resin, and the photosensitizer may be absorbed into the base resin. In some embodiments, absorption may include dissolving the photosensitizer in methyl ethyl ketone (MEK), tetrahydrofuran (THF), or another suitable solvent to form a solution. In some embodiments, absorption may include exposing the body 12 to the solution, causing the body 12 to absorb the solution and swell. In some embodiments, the body 12 may be co-extruded with the photosensitizer and another material using a die.

[0028] In some embodiments, the body 12 can actively resist bacterial colonization by releasing reactive oxygen species (ROS) in response to a light dose. In some embodiments, the range can be 0.5 J / cm³. 2 and 320J / cm 2A light dose is applied to a photosensitizer integrated with the body 12. In some embodiments, the duration of the applied light dose can range from 1 second to 1 hour. In some embodiments, the light dose can be red light (approximately 700 nm–635 nm), yellow light (approximately 590 nm–560 nm), or ultraviolet (UV) light, such as ultraviolet C. In some embodiments, the body 12 can passively resist bacterial colonization under ambient light, which can be applied to the photosensitizer integrated with the body 12. In some embodiments, in response to a light dose in the range of 0.5 J / cm 2 and 320J / cm 2 Compared to the ROS generated by light doses, photosensitizers can generate lower levels of ROS in response to ambient light.

[0029] In some embodiments, the light dose can activate the photosensitizer, and as the excited electrons are raised to higher energy levels, the photosensitizer can reach a first excited singlet state. The first excited singlet state can decay to a lower energy level through intersystem crossing to a state called the triplet state. The triplet state has a long lifetime, and due to this property, the photosensitizer can react with triplet oxygen molecules and other biomolecules. When the photosensitizer in the triplet state transfers energy to triplet oxygen, ROS called singlet oxygen can be generated. Both the triplet photosensitizer and singlet oxygen are unstable molecules, and therefore they can provide the body 12 with purifying and antibacterial resistance. In some embodiments, light of different wavelengths can be applied to the body 12 at different times, and / or the body 12 can include a variety of photosensitizers that can be activated in response to light of different wavelengths.

[0030] refer to Figure 1B In some embodiments, the medical device 10 may include a coating 15, which may be disposed on all or part of the surface of the body 12. In these embodiments, a photosensitizer may be disposed within the coating 15. In some embodiments, integrating the photosensitizer with the body 12 of the medical device 10 may include applying the coating 15 to the surface of the medical device 10. In some embodiments, the concentration of the photosensitizer within the coating 15 may be between 0.05% and 5%. In some embodiments, the photosensitizer may be dissolved in urethane, polyurethane, or another suitable solvent and may be cured on the body 12 to form the coating 15.

[0031] Now for reference Figure 2In some embodiments, the body 12 of the medical device 10 may include a catheter adapter 16 and / or a catheter 18 extending distally from the catheter adapter 16. In some embodiments, a photosensitizer may be integrated with the body 12 via one or more methods discussed with respect to FIG. 1. Thus, in some embodiments, the photosensitizer may be compounded with a base resin, disposed within a coating on the body 12, absorbed into the base resin, or co-extruded with another material. In some embodiments, the catheter 18 may be co-extruded with the photosensitizer and another material. In some embodiments, the catheter 18 may include a peripheral venous catheter, a midline catheter, or a peripherally inserted central catheter. In some embodiments, the catheter 18 may include a proximal end 20 secured within the catheter adapter 16 and a distal end 22 configured for insertion into a patient's vascular system.

[0032] In some embodiments, the extension tube 24 may extend from the catheter adapter 16. In some embodiments, the distal end of the extension tube 24 may be integrated with or coupled to a side port 26 of the catheter adapter 16. In some embodiments, the proximal end of the extension tube 24 may be integrated with or coupled to an adapter 28, which may include a Y-type adapter or another suitable adapter.

[0033] Now for reference Figure 3 In some embodiments, the medical device 10 may include a connector 29, which may include a body 12. In some embodiments, the connector 29 may include a needleless connector, such as a SMARTSITE needleless valve available from Beckton Dickinson, Franklin Lake, New Jersey. In some embodiments, the connector 29 may be coupled to an adapter 28 (e.g., see...). Figure 2 This can be connected to another adapter of a specific conduit adapter, the port of the specific conduit adapter, or another suitable location. In some embodiments, the photosensitizer can be integrated with the body 12 via one or more methods discussed with respect to FIG1. ​​Thus, in some embodiments, the photosensitizer can be compounded with a base resin, disposed within a coating on the body 12, absorbed into the base resin, or co-extruded with another material.

[0034] Now for reference Figure 4 In some embodiments, the medical device 10 may include a surgical mesh 30, which may include a body 12. In some embodiments, a photosensitizer may be integrated with the body 12 via one or more methods discussed with respect to FIG. 1. Thus, in some embodiments, the photosensitizer may be compounded with a base resin, disposed within a coating on the body 12, absorbed into the base resin, or co-extruded with another material.

[0035] Now for reference Figure 5A-5B, In some embodiments, the medical device 10 may include a dressing 32, which is used in conjunction with a medical device inserted into a patient's vascular system via a skin insertion point or puncture site, the dressing including a body 12. In some embodiments, a photosensitizer may be integrated with the body 12 via one or more methods discussed with respect to FIG1.

[0036] In some embodiments, dressing 32 may be configured for use with a medical device, such as catheter 18 (e.g., see...). Figure 2 The medical device has pierced the patient's skin, and a portion of the medical device protrudes from the skin. In some embodiments, the body 12 may include a slit 34 configured such that the body 12 can be positioned around the medical device and on the skin surface so that the body of the dressing surrounds and contacts the skin insertion point or puncture site. In some embodiments, the slit 34 may be formed in the body 12 by cutting, stamping, or other similar mechanical forming techniques. In some embodiments, the width of the slit 34 may be adapted to facilitate installation on a medical device already implanted within the patient's vascular system. In some embodiments, the slit 34 may allow the dressing 32 to completely surround the medical device at the skin insertion point or puncture site.

[0037] In some embodiments, the body 12 can take any geometric shape. In some embodiments, the body 12 can be disc-shaped. In some embodiments, the shape of the body 12 can include ellipse, triangle, square, rectangle, pentagon, hexagon, octagon, etc. In some embodiments, the body 12 can be made of any physiologically compatible material capable of being impregnated with or absorbing photosensitizers. In some embodiments, the body 12 can be composed of oxidized cellulose foam, collagen fibers, alginate hydrogel, or another suitable material.

[0038] In some embodiments, the body 12 may include an aperture 36 for receiving a medical device. In some embodiments, a slit 34 may extend from the aperture 36 to the periphery 38 of the body 12. In some embodiments, the slit 34 allows the body 12 to completely surround and contact a skin insertion site, such as a catheter 18 (see...). Figure 2 Medical devices such as [device name] can pass through this slit.

[0039] Now for reference Figure 6According to some embodiments, a chamber for providing light dose to a medical device 10 is shown. In some embodiments, the chamber may be disposed within a cover 42 (e.g., a box, container, etc.). In some embodiments, one or more sides of the chamber may include mirrors 44. In some embodiments, one or more light sources 46 may be disposed within the chamber. For example, the light sources may include one or more of the following: a first light source 46a, a second light source 46b, and a third light source 46c (the first, second, and third light sources may be referred to as "light source 46" in this disclosure).

[0040] In some embodiments, each of the light sources 46 can emit a light dose with a specific wavelength. In some embodiments, a first light source 46a can emit a first wavelength, a second light source 46b can emit a second wavelength, and a third light source 46c can emit a third wavelength. For example, the first light source 46a can emit ultraviolet C, the second light source 46b can emit red light, and the third light source 46c can emit yellow light. In some embodiments, the light sources 46 may include light-emitting diodes (LEDs). In some embodiments, the light sources 46 can be activated at different time periods and / or for different durations. In some embodiments, in response to the activation of the light source 46, different photosensitizers integrated with the body 12 can be activated, thereby generating free radicals and purifying the medical device 10 disposed within the chamber.

[0041] All examples and conditional language described in this disclosure are intended for pedagogical purposes to help the reader understand the present disclosure and the ideas made by the inventors for further development of the art, and should be construed as not being limited to such specific examples and situations. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of this disclosure.

Claims

1. A method of disinfecting a medical device, characterized in that, The disinfection method includes: positioning a medical device within a chamber, wherein the medical device includes a body and a photosensitizer integrated with the body, and wherein one or more sides of the chamber include a mirror and one or more light sources are positioned within the chamber; and a light dose ranging from 0.5 J / cm 2 to 320 J / cm 2 is applied to the photosensitizer integrated with the main body of the medical device for a duration ranging between 1 second and 1 hour.

2. The method of disinfecting of claim 1, wherein, The disinfection method further includes integrating the photosensitizer with the body of the medical device.

3. The method of disinfecting of claim 2, wherein, The body is formed from a base resin, wherein integrating the photosensitizer with the body of the medical device includes compounding the photosensitizer with the base resin.

4. The method of disinfecting of claim 2, wherein, Integrating the photosensitizer with the body of the medical device includes applying a coating on a surface of the body, wherein the photosensitizer is disposed within the coating.

5. The method of disinfecting of claim 2, wherein, The medical device includes a catheter adapter and a catheter extending distally from the catheter adapter, wherein integrating the photosensitizer with the body of the medical device includes co-extruding the catheter with the photosensitizer and another material.

6. The method of disinfecting of claim 2, wherein, The medical device includes a base resin, wherein integrating the photosensitizer with the body of the medical device includes absorbing the photosensitizer into the base resin.

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