Healthcare providers often access treatment areas through the use of elongated devices that penetrate or pierce a physiological boundary, such as the skin/epidermal system, gastrointestinal, urinary, nasal and ocular, to name several. The penetration of a foreign member introduces a risk of adverse results from infection resulting from the artificial path created by the inserted foreign member. Particularly in a healthcare environment, where many therapeutic procedures utilize these foreign members, the risk of provider or hospital caused infections is prevalent.
A wound is a disruption of the normal structure and function of the skin and soft tissue architecture. An acute wound demonstrates normal physiology, and healing is anticipated to progress through the expected stages of wound healing, whereas a chronic wound is broadly defined as one that is physiologically impaired.
To ensure proper healing through the expected stages, the wound base should be well vascularized, free of devitalized tissue, clear of infection, and moist. Wound dressings might help facilitate this process if they eliminate dead space, control exudate, prevent bacterial overgrowth, ensure proper fluid balance, demonstrate cost-efficiency, and are manageable for the patient and/or nursing staff. Wounds with progressive healing as evidenced by granulation tissue and epithelialization can undergo closure or coverage. All wounds are colonized with microbes; however, not all wounds are infected. Wound infections can lead to morbidity and mortality.
Surgical site infections (SSIs) are a common cause of health care-associated infection. SSIs are often localized to the incision site (superficial/deep incisional SSI) but can also extend into deep tissues. Careful infection control and efforts to reduce skin flora burden are essential to reduce morbidity and mortality.
Configurations herein are based, in part, on the observation that therapeutic procedures and treatment often involve a foreign member for transfer of fluids or samples between the human patient body and a treatment source or testing facility. Unfortunately, conventional approaches often involve the use of a foreign member such as a needle, vessel or probe to cross an external bodily boundary to access various organ systems for used in patient care. Insertion or breach into the bodily region by these foreign members can form a path for pathogens such as bacteria and other microorganisms to cause infection. Whether the foreign member remains for an extended period, or is withdrawn and leaves a wound, a path of vulnerability is exposed for pathogens. Accordingly, configurations herein substantially overcome the shortcomings of the infection risk presented by conventional foreign members by providing an antibacterial, antipathogen light source for illuminating or irradiating a treatment region defining an insertion point of epidermal, gastrointestinal, urinary, or oral breach by a foreign member used in the course of treatment.
Catheter usage for urinary tract intervention involves insertion of a catheter vessel for urethral engagement. An inserted catheter vessel or tube, even if sterile upon insertion, presents a path for pathogens into the urethra and bladder. A circumferential frame having an array of lights around a perimeter and directed for focusing on a central void for illuminating a catheter provides a barrier to passage of pathogens. The frame provides an antimicrobial and safe light emission having a wavelength of or around 222 nm far UVC or 405 nm visible blue light for eradicating any bacteria or pathogens prior to infiltration via the catheter vessel.
In the case of percutaneous breach, intravenous delivery of medication is an effective medium for medicinal treatment directly to blood or tissue, which allows the medication to be quickly delivered to a specific region. General bloodstream delivery avoids degradation that can occur by oral administration which must pass via the gastrointestinal barrier. Unfortunately, conventional approaches to percutaneous delivery, typically via a needle or similar insertion member, suffer from the shortcoming that they pose an infection risk from a breach of the natural dermal (skin) barrier which guards against infiltration of pathogens. Typically, an antimicrobial substance is applied around the insertion point of the needle, however such chemical based approaches generally have diminishing effects over time, and need repeated applications for continued effectiveness. Accordingly, configurations herein substantially overcome the shortcomings of chemical and topical approaches by providing an antimicrobial light dressing device, system and method for a percutaneous treatment that bathes a treatment region around the percutaneous insertion with an antibacterial illumination source for preventing pathogens around the insertion from entering via the dermal puncture created by the insertion. The antimicrobial light dressing device combines a circumferential body centered around the insertion, and an arrangement of LEDs around the body that focus the light around the insertion and onto a therapeutic region of the insertion. An opening in the circumferential body has an articulated protrusion for offsetting a medicinal vessel such as an IV tube off the skin surface to avoid blocking light to an area under the vessel. The result is a 360 degree coverage of antimicrobial light around the percutaneous insertion as the medicinal vessel contacts the skin surface only at the insertion point in the center of the treatment region.
The foregoing and other objects, features and advantages of the invention will be apparent from the following description of particular embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.
A device for the dressing of wounds and insertion sites of percutaneous and drug delivery devices provides circumferential protection of a wound or insertion site of a percutaneous or drug delivery device. In particular, the device is an integrated dressing for vascular and non-vascular percutaneous medical devices (e.g., IV catheters, central venous lines, arterial catheters, dialysis catheters, peripherally inserted coronary catheters, mid-line catheter, drains, chest tubes, externally placed orthopedic pins, ventricular assist device drivelines, and epidural catheters) comprising an adhesive dressing and an antimicrobial light source, such as visible light, far UVC light, and any suitable electromagnetic emission of a therapeutically beneficial wavelength. The dressing device reduces infection risk from vascular and non-vascular percutaneous medical devices by providing sufficient tissue-safe antimicrobial light at a wound or insertion site.
In the antimicrobial epidermal device 100, the circumferential body 110 is adapted for epidermal placement on the treatment region 50 of a larger epidermal surface 10. Placement is based on a central void 120 in the circumferential body for epidermal access and alignment generally over the insertion site 52. The circumferential body 110 includes an illumination source disposed for emitting a therapeutic light on the treatment region 50 defined by the central void 120. An adhesive member 116, such as a patch or bandage, adheres the circumferential body 110, vessel 140 and a percutaneous penetration member such as a needle to the epidermal area around the treatment region 50.
The configuration of
The proximate layer 110-1 engages with the adhesive member 116, which may be integrated as an adhesive whole or applied in separate phases. In the configuration of
In
A power connection 113 receives the power supply 111 on the circumferential body 110. The power supply couples to the illumination source 130 and is adapted for receiving an electrical source for powering the illumination source, such as an external USB, batteries, AC or similar AC or DC source based on the electrical requirements of the illumination source 30. A discontinuity in the circumferential body defines the vessel gap 122 for accommodating the treatment vessel 140. The treatment vessel 140 couples to the percutaneous insertion member in the treatment region 50 under the central void 120. Routing of the treatment vessel 140 is provided by a protrusion 124 extending outward from the circumferential body. The protrusion 124 has an elevated surface 126 disposed away from the epidermal surface 10, such that the elevated surface 126 is adjacent the vessel gap 122 for directing the treatment vessel at an offset distance from the dermal surface 10. Elevation of the treatment vessel 140 above the skin avoids a shadow from the light and instead allows a shadowed region 125 to be reached by light from the illumination source 130 rather than being shaded or obscured by the vessel 140 from reaching the skin at the shadowed region.
In either configuration, the circumferential body 110 is disposed onto the treatment region 52. The circumferential body 110 extends generally circular around a central void 120, and placement centers the central void around the insertion site so that the central void allows clearance for the medication vessel 140 and any uninserted portion of the rigid insertion member. The circumferential body 110 may be any suitable shape and size based on the treatment region 50 and the intensity of the illumination source 130 thereby irradiating the treatment region.
The circumferential body 110 includes a discontinuous portion defining the vessel gap 122, which may be continuous with the central void 120. In conjunction with placement of the circumferential body 110, the medication vessel is routed over the elevated surface 126 on the protrusion 124 extending from the circumferential body for permitting the vessel to extending through the vessel gap 122 above and out of contact with the skin surface. The treatment region 50 is illuminated from one or more LEDs (Light Emitting Diodes) 132 disposed on an inner surface of the circumferential body 110 for irradiating an illumination cavity 118 defined by the inner surface and the central void. The LEDs 132 or other illumination source irradiate the treatment region for maintaining an antimicrobial and sterile environment around the insertion site 50. This prevents pathogens from entering the patient along the insertion member 150.
In a particular configuration shown in
In a particular configuration, the illumination source includes one or more light emitting diodes (LEDs) 432, such that each LED provides an antimicrobial and safe light emission in a wavelength around 222 nm or 405 nm. A wavelength in a range between 217-227 nm or 400-410 nm may also provide beneficial results.
The frame 410 may be formed from a light conductive medium formed including one or more of light-transmissive materials such as polymethyl methacrylate (PMMA), silica/quartz, thermoplastic polyurethane (TPU), flexible acrylic, transparent polyvinyl chloride (PVC), UV-inhibitor-free transparent PVC and solar cell material.
In particular configurations, the frame 410 has an adhesion on an underside, similar to the IV irradiation device above, where the adhesion provides temporary attachment to the dermal surface in a region surrounding the epidermal treatment region. Adhesion can also seal the dermal area if the frame 410 is sufficiently flush with the soft tissue in the epidermal treatment region 450, which provides a barrier to further infections influx while the illumination source eradicates the pathogens already in the treatment region defined by the frame 410. The illumination source and/or LEDs generate a light source having a wavelength of 222 nm far UVC or 405 nm visible blue light, or of similar wavelengths having comparable antibacterial effects for eradicating microorganisms.
The wound closure safety device also employs a connection 434 to a power supply for activating the illumination source, or may be powered by on-board batteries. When used as a wound treatment, it is expected that constant usage, such as for inpatient recovery, would be best suited by a hardwired power source.
A corresponding method for deployment of the epidermal device for sterile maintenance of a wound region includes identifying an epidermal treatment region 450 having a therapeutic need for a sterile environment, such as an incision 452 healing. The frame 410 arranges an array of illumination elements of LEDs 432 on the frame for defining an illumination source, where the frame having a shape based on the epidermal treatment region 450. Various sizes of frames 410 may be employed, similar to the manner in which various sizes of bandages are employed for various size skin regions. The frame engages an epidermal surface at the treatment region 450 for directing light of the predetermined therapeutic wavelength at the epidermal treatment region, and energizes the illumination source for irradiating the epidermal treatment region with the light of the therapeutic wavelength.
While the system and methods defined herein have been particularly shown and described with references to embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.
This Patent Application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent App. No. 63,215,910, filed Jun. 28, 2021, entitled “ANTIMICROBIAL LIGHT-EMITTING DEVICES,” and is a Continuation-in-Part (CIP) of U.S. patent application Ser. No. 17/665,965, filed Feb. 7, 2022, entitled “ANTIMICROBIAL LIGHT-EMITTING PERCUTANEOUS SITE DRESSING,” which claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent App. No. 63,146,697, filed Feb. 7, 2021, entitled “ANTIMICROBIAL LIGHT DRESSING DEVICE,” incorporated herein by reference in entirety.
Number | Date | Country | |
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63146697 | Feb 2021 | US | |
63215910 | Jun 2021 | US |
Number | Date | Country | |
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Parent | 17665965 | Feb 2022 | US |
Child | 17851572 | US |