Patent Application
20240173563
This application is based on and claims priority under 35 U.S.C. 119 to Korean Patent Application No. 10-2022-0159260, filed on Nov. 24, 2022, in the Korean Intellectual Property Office, the disclosure of which is herein incorporated by reference in its entirety.
The present disclosure relates to a light-based disinfection device. In particular, the present disclosure relates to a device that is capable of disinfecting a site around a skin tissue where a drug is injected based on light, such as laser beams, near-ultraviolet rays, visible rays, or near-infrared rays during, in close proximity to an injection needle for gradual drug injection into a patient's body, hemodialysis, or the like drug injection.
Injection needles are used for gradual drug injection into a patient's body, such as IV injection or injection using an implantable central venous catheter, or for hemodialysis, wherein disinfection of the injection needle inserted into the skin is essential to prevent the risk of inflammatory infection such as bacterial infection.
For example, during anticancer treatment, an implantable central venous tube (chemoport) is inserted into the patient's upper left subcutaneous fat layer for repeated administration of anticancer drugs. The implantable central venous catheter has the advantage of allowing intravenous injection without securing a blood vessel and allowing the patient to move freely during the injection of drugs, but caution is required as bacterial infection may occur. In particular, since disinfection is required when using needles and periodic needle replacement is required, an additional disinfection process is necessary to prevent the risk of inflammatory infection for safe anticancer treatment.
As related prior documents, U.S. Pat. No. 10,307,612 (issued on Jun. 4, 2019), U.S. Pat. No. 11,020,570 (issued on Jun. 1, 2021), and the like may be referred to.
Accordingly, the present disclosure was made to solve the above-mentioned problems, and the present disclosure provides a light-based disinfection device that is capable of minimizing and preventing infection by broadly and uniformly radiating light, such as laser beams, near-ultraviolet rays, visible rays, and near-infrared rays, to an area around a skin tissue where the drug is injected in close proximity to an injection needle for administering an anticancer drug or the like during drug injection to ensure that the site where the skin tissue and the injection needle are in contact with each other and the surroundings of the site are disinfected.
First, the features of the present disclosure may be summarized as follows. In view of the foregoing, a light-based disinfection device according to an aspect of the present disclosure configured to achieve disinfection of a skin tissue by placing light in close proximity to an injection needle for drug injection, the light-based disinfection device may include: a light delivery catheter including one end portion connected to a control device and the other end portion configured to direct light from a light source controlled by the control device toward skin tissue; a needle catheter including one end portion connected to a drug container and to accommodate a catheter line that supplies a drug, and the other end portion configured to accommodate an injection needle that receives the drug from the catheter line and injects the drug into a patient's body; and a coupler configured to couple the light delivery catheter and the needle catheter in parallel to each other in a longitudinal direction.
The light-based disinfection device may be used to insert the injection needle of the needle catheter into a chemoport inserted into a patient's body, and may also be used for the administration or the like of any injection drug that takes a certain amount of time, from an IV injection liquid container or the like.
The light source may be an optical element disposed at the other end portion of the light delivery catheter to be connected to control lines and power lines extending from the control device, and may be an optical fiber that delivers light generated by the control device and has an end portion disposed at the other end portion of the light delivery catheter.
The light source may be configured to emit laser beams, near-ultraviolet rays, visible rays or near-infrared rays as continuous or pulsed light with a wavelength ranging from 400 nm to 3000 nm and an energy density of 0.01 to 10 J/cm2, and power density of 0.01 to 10 W/cm2.
The light source may be configured to be controlled by the control device in terms of one or more disinfection conditions from among a light intensity, a light emission time, selection of a continuous or pulsed light delivery method, a light output energy or power range, selection of a light distribution, and a number of times of disinfection operation.
The light-based disinfection device may further include a user terminal connected to the control device in a wired or wireless manner, wherein the user terminal may be configured to control an operation of the light source by transmitting the disinfection conditions or a schedule including one or more lists of the disinfection conditions stored in advance to the control device, to store information on the controlled disinfection conditions or schedule which have been transmitted to the control device and under which the operation of the light source has been controlled, and to provide the information in response to a user's inquiry request.
The light may be radiated toward the end portion of the injection needle at an angel of 30 to 90 degrees by the other end portion of the light delivery catheter.
The light delivery catheter may further include a light diffusion prevention film at the other end portion to block light reflected or scattered rearward when the light from the light source is radiated to the skin tissue.
The light diffusion prevention film may be configured to be rotatable or bendable.
The light diffusion prevention film may include a coating film configured to reflect or scatter light.
The light diffusion prevention film may include a coating film configured to absorb light.
The coupler may include a catheter connector configured to be placed and rotated around the light delivery catheter or the needle catheter.
The coupler may include a tube configured to wrap bodies of the light delivery catheter and the needle catheter to place the bodies of the light delivery catheter and the needle catheter therein.
When the end portion of the injection needle at the other end portion of the needle catheter is bent and directed in a different direction with respect to the longitudinal direction, the other end portion of the light delivery catheter may extend in an extension direction without being bent.
When the end portion of the injection needle at the other end portion of the needle catheter is bent and directed in a different direction with respect to the longitudinal direction, the other end portion of the light delivery catheter may be bent in the other direction to direct the light toward the skin tissue.
When the injection needle at the other end portion of the needle catheter extends in an extension direction without being bent, the light source disposed at the other end portion of the light delivery catheter may be configured to be rotatable or bendable such that a light radiation direction can be changed.
The other end portion of the light delivery catheter may include a light radiation portion having a hole for inserting the injection needle, and a plurality of light sources controlled by the control device may be arranged around the hole of the light radiation portion.
The light-based disinfection device may further include a light radiation regulation portion configured to diffuse or scatter the light from the other end portion of the light delivery catheter to regulate the light to have a predetermined light radiation range, light radiation intensity, or light distribution on the skin tissue.
With the light-based disinfection device of the present disclosure, it is possible to minimize and prevent infection by radiating light such as laser beams, near-ultraviolet rays, visible rays, or near-infrared rays widely and uniformly around the skin tissue in close proximity to the injection needle during drug injection to ensure that the site where the skin tissue and the injection needle are in contact with each other and the surroundings of the site are disinfected. For example, when administering an anticancer drug by inserting an injection needle into the chemoport, the needle insertion site and the surroundings of the needle insertion site can be disinfected by applying the light-based disinfection device of the present disclosure in the vicinity of the needle, and the light-based disinfection device can also be applied to the surrounding transplanted tissues, which allows for extensive optical disinfection. In addition, infection around the chemoport can be prevented by performing periodic non-contact optical disinfection by applying the light-based disinfection device of the present disclosure during or after anticancer drug administration. In addition, it is expected that the light-based disinfection device of the present disclosure can be used in various implantable devices or the like.
The accompanying drawings, which are included as a part of the detailed description to help the understanding of the present disclosure, provide embodiments of the present disclosure and illustrate the technical spirit of the present disclosure together with the detailed description, in which:
Hereinafter, the present disclosure will be described in detail with reference to the accompanying drawings. Herein, like components in each drawing are denoted by like reference numerals if possible. In addition, detailed descriptions of already known functions and/or configurations will be omitted. In the following description, components necessary for understanding operations according to various embodiments will be mainly described, and descriptions of elements that may obscure the gist of the description will be omitted. In addition, some elements in the drawings may be exaggerated, omitted, or schematically illustrated. The size of each component does not entirely reflect the actual size, and therefore, the descriptions provided herein are not limited by the relative sizes or spacings of the components drawn in each drawing.
In describing the embodiments of the present disclosure, when it is determined that a detailed description of the known technology related to the present disclosure may unnecessarily obscure the subject matter of the present disclosure, the detailed description will be omitted. In addition, terms to be described later are defined in consideration of functions in the present disclosure and may vary according to the intention, custom, or the like of a user or operator. Therefore, the definitions of the terms should be made based on the description throughout this specification. Terms used in the detailed description are only for describing the embodiments of the present disclosure, and should not be treated as limiting. Unless expressly used otherwise, an expression in the singular form includes the meaning in the plural form. In this description, expressions such as “including” or “comprising” are intended to indicate any features, numbers, steps, operations, elements, or some or combinations thereof, and should not be construed to exclude the existence or possibility of one or more other features, numbers, steps, operations, elements, or some or combinations thereof.
In addition, terms such as “first” and “second” may be used to describe various components, but the components are not limited by the terms, and these terms are only used for the purpose of distinguishing one component from another.
First, a description will be made of the principle of a delivery device of the present disclosure in which diseases are treated by inducing stimulation, destruction, incision, or coagulation of a lesional tissue with cancer or other symptoms in a digestive organ system by radiating light, such as laser beams, near-ultraviolet rays, visible rays, or near-infrared rays to a target lumen or tubular lesion tissue.
Low-level laser therapy induces stimulation, destruction, incision, or coagulation of lesion tissue and includes low-power therapy, photodynamic therapy, photothermal therapy, and the like. The low-level laser therapy is based on a treatment principle of stimulating cell activity and vitality without damaging issue by a non-invasive and non-thermal method by generally radiating light with a wavelength ranging from 400 to 3000 nm at an intensity equal to or less than 100 J/cm2. Such low-level laser therapy is capable of achieving clinical effects by radiating a predetermined level of electromagnetic energy to stimulate or inhibit cellular functions. Here, light sources of near-ultraviolet rays, visible rays, near-infrared rays, and the like may be applicable for pain relief, inflammation, swelling, tissue necrosis prevention, tissue recovery, and the like. The low-level laser therapy may maximize the treatment effect depending on the exact wavelength required for treatment, appropriate power, distribution of electromagnetic energy, and control of the amount of electromagnetic energy. In addition, LED chips may be used to generate electromagnetic energy, and the power varies depending on the wavelength, wherein, in the LED chips that have been developed so far, the near-ultraviolet region of the 400 nm band has an optical output of 20 mW, the 850 to 900 nm band has an optical output of 10 mW or more, and the 600 to 700 nm band, which is effective in relieving pain, has an average power of up to 40 mW.
The typical initial response of cells to light radiation is an increase in adenosine triphosphate (ATP) and calcium ions. ATP and calcium ions increase, and the energy generated at this time may increase mitochondria potential, activate second messengers (CAMP, cGMP, heat shock protein, and the like), and adjust the amount of generation of reactive oxygen species (ROS). In particular, differentiation, migration, and proliferation of normal cells may be induced by 7 regulating the amount of ROS, and in damaged states of the tissue, antioxidant effects and inflammation-relieving effects may be induced by reducing the amount of ROS.
The mechanism of low-level lasers on cellular function relies on photon absorption by cytochrome c (CCO), which plays an important role in oxygen metabolism and adenosine triphosphate (ATP) production. Low-level lasers may increase the concentration of cytochrome c, which may lead to a longer-term metabolic effect, resulting in an effect of improving cellular oxygen metabolism. Low-level lasers may adjust molecule-dependent biological processes such as growth factor production, cell proliferation, migration, and cell death. Fibroblasts, which are the main mechanism of fibrosis, are transformed into myofibroblasts by growth factors during a wound healing process. During this process, excessive expression of growth factors leads to abnormal expression of extracellular matrix and formation of collagen, causing fibrosis. The treatment principle of red light in the 600 to 800 nm wavelength range is to reduce the expression of induced growth factors that cause stenosis, that is, fibrotic disease. Blue light in the 400 nm wavelength range functions to directly generate reactive oxygen species (ROS) and photo-stimulate flavin attached to the complex of mitochondrial electron transport chain, and may induce and adjust changes in cytokines, growth factors, and inflammatory mediators that promote inflammatory responses.
Laser radiation with red light not only has the effect of normalizing excessive fibrotic activity in metastasis-induced fibroblasts by regulating growth factors, but also has an anti-inflammatory effect by regulating prostaglandin E2 production and cyclooxygenase (COX) m-RNA expression. In addition, the laser in the 600 to 800 nm wavelength range reduces inflammatory responses based on the mechanism of inhibiting intracellular reactive oxygen species in blood pressure via the action of peroxide-removing enzymes and catalase enzyme activity and changing calcium (Ca2) mobilization. The blue light laser in the 400 nm wavelength ranges may perform functions such as directly generating reactive oxygen species (ROS) and optically stimulating flavins attached to complexes of mitochondrial electron transport chains, and induces and regulates changes in cytokines, growth factors, and inflammatory mediators that promote inflammatory responses. The infrared laser in the 900 nm wavelength range has an anti-inflammatory effect that alleviates inflammatory responses based on the mechanism of reducing the immune response to allergens by suppressing histamine release. In addition, an infrared laser, with its high penetration capability, has effects on cell proliferation, neovascularization, collagen accumulation, and re-epithelialization in a wound healing process.
Photodynamic therapy injects a photosensitizer (or photosensitizing agent) into a patient's body to accumulate the same in the patient's body, and uses light energy to destroy diseases or tumors. When the photosensitizer absorbs light energy, reactive oxygen (reactive singlet oxygen) is generated, which directly causes necrosis or death of cells and eliminates diseases or tumors. In the photodynamic therapy, the wavelength range of 600 to 800 nm is frequently used, and light energy is radiated several days after the photosensitizer is administered. The effect of photodynamic therapy varies depending on the type and dosage of the photosensitizer, the drug-light interval, wavelength (nm), radiation intensity (mW), radiation energy (J), and the number of times of radiation. Photodynamic therapy is a photochemical process that does not generate heat and has little impact on surrounding tissues, so there is less deformation of the underlying tissue compared to heat-based treatments, but evenly delivering light to the side of the optical fiber has a significant impact on the treatment effect.
Photothermal therapy, unlike low-level laser treatment or photodynamic therapy, uses high energy to deliver light energy to tissues, causing the chromophore within the tissues to absorb the light to increase the temperature, thereby inducing necrosis in diseases, tumor tissues, or the like. Light energy is first absorbed into the tissue, then heat is generated, raising the temperature, and as the heat is conducted to surrounding tissues, affecting the composition or combination of the tissue. Various biological changes occur depending on the temperature generated within the tissue. When the temperature is 42° C., a thermal effect and protein shrinkage occur, when the temperature is 50° C., a decrease in enzyme activity and slowing of cell movement occur, when the temperature is 60 to 70° C., protein denaturation and coagulation occur, when the temperature is 80° C. osmosis of cell membrane occurs, when the temperature is 100° C. vaporization, thermal decomposition, removal, and destruction occur, and when the temperature is above 100° C., dissolution, carbonization, and the like occur. In order to induce tissue changes as temperature rises, light energy must be delivered uniformly to ensure high treatment effectiveness and safety. Temperature rise (ΔT, ° C.) may be predicted by using [Equation 1], wherein μa is tissue absorption rate (1/cm), H is light energy per unit area (J/cm2), ρ is tissue density (kg/cm3), c is tissue specific heat (J/kgK). To increase the effect of photothermal therapy, light energy, pulse length, beam size, repetition rate, wavelength, and optical/thermal characteristics of tissues must be carefully considered and selected.
ΔT=μaH/ρc [Equation 1]
The present disclosure focuses on the above-described low-level light therapy, photodynamic therapy, and photothermal therapy methods and applies them to a light-based disinfection device, wherein the light-based disinfection device widely and uniformly radiates light, such as laser beams, near-ultraviolet rays, visible rays, and near-infrared rays, around a skin tissue where the drug is injected in close proximity to the injection needle during drug injection, thereby disinfecting the area where the skin tissue and the injection needle are in contact with each other, thereby minimizing and preventing infection. For example, when administering an anticancer drug by inserting an injection needle into the chemoport, the needle insertion site can be disinfected by applying the light-based disinfection device of the present disclosure in the vicinity of the needle, and the light-based disinfection device can also be applied to the surrounding transplanted tissues, which allows for extensive optical disinfection. In addition, infection around the chemoport can be prevented by performing periodic non-contact optical disinfection by applying the light-based disinfection device of the present disclosure during or after anticancer drug administration. In addition, it is expected that the light-based disinfection device of the present disclosure can be used in various implantable devices or the like.
Referring to
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The catheter line 121 may be supported by being fixed to the patient's body, a surrounding holder, or the like via a clip 50. The light delivery catheter 112 and the needle catheter 122, which are coupled and fixed by the coupler 130, are fixed at a predetermined distance from the patient's body so as not to shake while the drug is administered to the patient through the injection needle 123. In order to ensure that the light delivery catheter 112 and the needle catheter 122 are fixed at a predetermined distance from the patient's body so as not to shake as described above, a fixation tool 60 may be used. The fixation tool 60 may be shaped to surround the light delivery catheter 112 and the needle catheter 122, and may be provided with an adhesive material (e.g., in the form of adhesive tape) attached to the patient's body, at least on its opposite sides.
Referring to
Here, the light source 11 disposed at the other end portion of the light delivery catheter 112 may be an end portion of an optical fiber or an optical element. The optical device may be a variety of light-generating devices for optical disinfection, such as a light emitting diode (LED), a diode laser element, a pulsed laser element, a semiconductor laser element, and a diode pumped solid state (DPSS) laser device. When the optical element is placed at the other end portion of the light delivery catheter 112, the optical element may be connected to control lines and power lines 111 extending from the control device 90. When the optical element is placed in the control device 90, the light generated in the control device by the optical element may be delivered to the end portion of the optical fiber fixed to the other end portion via the optical fiber 111. The end portion of the optical fiber may be protected by being wrapped with an appropriate protective material that is effective in dissipating light.
The light source 11 may emit laser beams, near-ultraviolet rays, visible rays, or near-infrared rays with a wavelength ranging from 400 nm to 3000 nm as continuous or pulsed light with an energy density ranging from 0.01 to 10 J/cm2, and a power density ranging from 0.01 to 10 W/cm2. Regarding the light source 11, under the control of the control device 90, one or more disinfection conditions may be controlled from among a light intensity (or selection in the above-mentioned wavelength range), a light emission time (variously applicable for, for example, 30 seconds to 10 minutes), selection of a continuous or pulsed light delivery method, an output energy or power range of the light (selection from the above energy/power density range), selection of a light distribution (whether optional use of the light radiation adjusting portion in
As illustrated in
Such a user terminal transmits the above-mentioned disinfection conditions or a schedule including one or more lists of the disinfection conditions stored in advance (e.g., disinfection conditions to operate in a predetermined order) to the control device 90 to control the operation of the light source 11. In addition, the user terminal may store information on the disinfection conditions or schedule which have been transmitted to the control device 90 and under which the operation of the light source 11 has been controlled, so that the corresponding information is provided in response to a user's inquiry request made in the future.
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The light delivery catheter 112, the needle catheter 122, and the connector-type coupler 130 may be made of polytetrafluoroethylene (PTFE), polyethylene, polyvinyl chloride, nylon 66, 11, 12, urethanes, polyurethanes, polypropylene, polycarbonate, ABS, Pebax, polyetheretherketone (PEEK), or polyethylene terephthalate (PET).
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Although not illustrated in the drawing, when the end portion of the injection needle 123 at the other end portion of the needle catheter 122 is bent and directed in a different direction with respect to the longitudinal direction as described above, the other end portion of the light delivery catheter 112 may be extended in an extension direction without being bent. At this time, in order to secure the disinfection range, the light source 11 of the light delivery catheter 112 may be arranged to be directed toward the end portion of the injection needle 123 by the rotatable or bendable mechanical member. The angle of the radiated light 150 may be 30 to 90 degrees.
Referring to
The light radiation portion 200 in which the plurality of light sources 11 are arranged may also be arranged to be directed toward the end portion of the injection needle 123 in the direction of a predetermined angle (e.g., 10 to 30 degrees) by the rotatable or bendable mechanical member. Light beams from the plurality of light sources 11 may be radiated to the skin tissue in an overlapping manner, or may be radiated to the skin tissue independently without overlapping. The plurality of light sources 11 may be configured such that each light source radiates light beams having the same wavelength, the light sources radiate light beams having different wavelengths from group to group, or all the light sources may radiate light beams having different wavelengths.
Referring to
In order to radiate the light 150 from the light source 11 to the skin tissue at a predetermined energy density during optical disinfection, the light radiation regulation portion 300 may be made of a light diffusion or scattering material or may have a layer of the material on the surface or inside a transparent material. Alternatively, when the light radiation regulation portion 300 is for diffusion, the light radiation regulation portion 300 may be provided with grooves on its surface (one side or both sides) continuously/discontinuously and symmetrically/asymmetrically to enable light diffusion. Alternatively, when the light radiation regulation portion 300 is for scattering, a scattering material (e.g., SiO2, nano or micro particles, or the like) may be placed on or inside the transparent surface of the light radiation regulation portion 300.
Similar to detachably attaching the light delivery catheter 112 to the needle catheter 122 by using the catheter connector 130, the light radiation regulation portion 300 may be configured to be detachably attached to the other end portion of the light delivery catheter 112 by using an additional connector 135. The additional connector 135 may be configured to be rotatable along the circumference of the body of the light delivery catheter 112, and the light radiation regulation portion 300 may be configured to be rotatably or bendably coupled to the additional connector 135.
This light radiation regulation portion 300 may include respective elements for the above-mentioned functions, and in some cases where the disinfection conditions such as light radiation range, light radiation intensity, and light distribution are selected under the control of the control device 90, the corresponding elements of the light radiation regulation portion 300 may be selected so that disinfection can be performed. The selection of the corresponding elements of the light radiation regulation portion 300 may be made automatically under electronic control, or may be manually performed by a user by displaying the corresponding information on a display device such as an LCD or LED to notify the user of the information.
Referring to
For example, when the injection needle 123 is inserted vertically when administering an anticancer drug, it is possible to optically disinfect the site where the injection needle 123 is inserted into the skin tissue and the surrounding tissue at a predetermined distance from the site at the same time by placing the light delivery catheter 112 in parallel to the needle catheter 122 and bending the end portion of the light delivery catheter 112 by a predetermined angle or by forming the light radiation direction from the light source 11, such as an optical fiber, at a predetermined angle.
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As described above, with the light-based disinfection device 100 of the present disclosure, during drug injection, it is possible to minimize and prevent infection by radiating light such as laser beams, near-ultraviolet rays, visible rays, or near-infrared rays widely and uniformly around the skin tissue in close proximity to the injection needle 123 during drug injection to ensure that the site where the skin tissue and the injection needle 123 are in contact with each other and the surroundings of the site are disinfected. For example, when administering an anticancer drug by inserting the injection needle 123 into the chemoport 70, the site where the injection needle 123 is inserted and its surroundings can be disinfected by applying the light-based disinfection device 100 of the present disclosure around the injection needle 123, and the light-based disinfection device can also be applied to the surrounding transplanted tissues, which allows for extensive optical disinfection. In addition, infection around the chemoport 70 can be prevented by performing periodic non-contact optical disinfection by applying the light-based disinfection device 100 of the present disclosure during or after anticancer drug administration. In addition, it is expected that the light-based disinfection device 100 of the present disclosure can be used in various implantable devices or the like.
As described above, the present disclosure has been described based on specific details, such as specific components, limited embodiments, and drawings, but these are only provided to help a more general understanding of the present disclosure, and the present disclosure is not limited to the above-described embodiments. A person ordinarily skilled in the art to which the present disclosure pertains may make various modifications and changes without departing from the essential characteristics of the present disclosure. Therefore, the spirit of the present disclosure should not be limited to the described embodiments, and not only the appended claims, but also all technical ideas equivalent to or equivalently modified to the claims should be interpreted as being included in the scope of the present disclosure.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10-2022-0159260 | Nov 2022 | KR | national |
