CN115770347A - Medical antibacterial catheter, medical antibacterial catheter system and sterilization method - Google Patents
Medical antibacterial catheter, medical antibacterial catheter system and sterilization method Download PDFInfo
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- CN115770347A CN115770347A CN202111046360.1A CN202111046360A CN115770347A CN 115770347 A CN115770347 A CN 115770347A CN 202111046360 A CN202111046360 A CN 202111046360A CN 115770347 A CN115770347 A CN 115770347A
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Abstract
The present application relates to a medical antibacterial catheter, a medical antibacterial catheter system and a sterilization method, the medical antibacterial catheter comprising: a catheter body; and one end of the optical fiber is a driving end and is provided with a light source connector, the other end of the optical fiber is a working end, and the length of the optical fiber at least can extend to a preset area of the catheter body in the catheter body.
Description
Technical Field
The application relates to the field of medical equipment, in particular to a medical antibacterial catheter, a medical antibacterial catheter system and a sterilization method.
Background
Minimally invasive treatment is a common treatment means in clinic at present, and is realized by establishing an in-vivo and in-vitro channel to convey consumables such as a catheter and the like into a body and taking out the consumables after treatment. Due to clinical requirements, such extracorporeal pathways often need to be maintained for long periods of time. The in vivo and in vitro channels are also the hotbeds of bacteria, which are very easy to cause infection. And at the time of finishing the operation, changing the medicine and the like, the channel position needs to be subjected to spraying disinfection by adopting chlorhexidine, iodophor and the like, and the outer surface is sterilized by being wrapped by gauze and the like after the disinfection. In addition, at present, in clinical practice, besides intravenous infusion of antibiotics, antibacterial catheters are manufactured on the surfaces of the catheters in a slow-release antibiotic manner.
In the clinical treatment process, the current clinical disinfection mode is only disinfection at fixed time and fixed point, the aseptic state of the wound can not be completely ensured, if the spraying disinfection is not thorough, the infection risk is increased, the infection is caused, the prognosis is influenced, and the treatment cost is increased. In addition, the use of antibiotics is prone to in vivo flora chaos, bacterial resistance and superinfection problems.
Disclosure of Invention
In view of the above, it is necessary to provide a medical antibacterial catheter, a medical antibacterial catheter system and a sterilization method.
The application provides a medical antibiotic pipe, includes:
a catheter body;
and one end of the optical fiber is a driving end and is provided with a light source connector, the other end of the optical fiber is a working end, and the length of the optical fiber at least can extend to a preset area of the catheter body in the catheter body.
Several alternatives are provided below, but not as an additional limitation to the above general solution, but merely as a further addition or preference, each alternative may be combined individually for the above general solution or between several alternatives without technical or logical contradictions.
Optionally, the optical fiber is made of any one of glass optical fiber, plastic optical fiber, quartz optical fiber and liquid core optical fiber.
Optionally, the medical antibacterial catheter further comprises a bactericidal coating, and the bactericidal coating is coated on the periphery of the preset area of the catheter body.
Optionally, the bactericidal coating is a hydrogel layer loaded with carvacrol.
Optionally, the hydrogel layer is coated on the periphery of the predetermined area by chemical grafting or physical coating.
Optionally, the optical fiber has a hydrophilic PVP cladding on its outer surface.
Optionally, the length of the working end of the optical fiber is 0.1-10 cm, and the working end has a divergent irradiation direction.
Optionally, a fluorescent material is added to the optical fiber material of the working end.
Optionally, the working end has a diffusely reflective outer surface. Optionally, at least one of the catheter body and the optical fiber is provided with a mark indicating the insertion depth of the catheter body and the optical fiber.
Optionally, the catheter body is an interventional catheter.
The present application further provides a medical antimicrobial catheter system comprising:
a catheter body;
one end of the optical fiber is a driving end and is provided with a light source connector, the other end of the optical fiber is a working end, and the length of the optical fiber can at least extend to a preset area of the catheter body in the catheter body;
and the light source is connected with the optical fiber by adopting a light path.
Optionally, the light source has an adjustable light emitting wavelength, and the light emitting wavelength at least includes 10nm to 420nm.
Optionally, the outer periphery of the predetermined region of the catheter body is further covered with an antimicrobial coating.
The present application also provides a sterilization method, comprising:
the catheter body is inserted to a designated position, and the periphery of a preset area of the catheter body is covered with an antibacterial coating;
extending the working end of the optical fiber into the catheter body to a predetermined region;
and (4) performing illumination sterilization by using the optical fiber.
Optionally, the outer periphery of the predetermined region of the catheter body is further covered with a sterilization coating, and the implementation of light sterilization by using the optical fiber specifically includes:
performing first-stage illumination by using an optical fiber, and maintaining the first time, wherein the wavelength of light irradiated in the first stage is 10-400 nm;
and performing second-stage illumination by using an optical fiber, and maintaining for a second time, wherein the wavelength of the light irradiated in the second stage is 400-420 nm.
The sterilization method herein may be practiced using the medical antimicrobial catheter system described herein.
Drawings
FIG. 1 is a schematic view of a medical antimicrobial catheter according to an embodiment of the present disclosure;
fig. 2 is a schematic structural diagram of a medical antibacterial catheter system according to an embodiment of the present application.
The reference numerals in the figures are illustrated as follows:
10. a catheter body; 11. a predetermined area; 20. a bactericidal coating; 30. an optical fiber; 31. a driving end; 32. a working end; 33. a light emitting layer;
40. a light source; 41. a light source connector; 50. a host;
A. in vitro; B. in vivo.
Detailed Description
The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When a component is referred to as being "disposed on" another component, it can be directly on the other component or intervening components may also be present.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.
In this application, the terms "comprises" and "comprising," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a system, article, or apparatus that comprises a list of elements is not necessarily limited to those elements explicitly listed, but may include other elements not expressly listed or inherent to such system or apparatus.
In this application, the terms "center", "length", "width", "thickness", "top end", "bottom end", "up", "down", "left", "right", "front", "back", "vertical", "horizontal", "inside", "outside", "axial", "circumferential", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in some drawings, or based on the spatial attitude of the product in normal use, and are of course only for the convenience of describing and simplifying the present application, and do not indicate or imply that the position or element referred to must have a particular orientation, be of particular construction and operation, and thus should not be construed as limiting the present application.
To solve the technical problems in the prior art, as shown in fig. 1, an embodiment of the present application provides a medical antibacterial catheter, including:
a catheter body 10;
an optical fiber 30 having a driving end 31 with a light source connector 41 and a working end 32, the optical fiber 30 having a length at least capable of extending within the catheter body 10 to a predetermined region 11 of the catheter body 10.
In this embodiment, working end 32 of optical fiber 30 extends into predetermined region 11 of catheter body 10, and driving end 31 of optical fiber 30 transmits light to working end 32 via light source adapter 41. When the optical fiber 30 transmits the sterilizing light having the sterilizing effect specific wavelength, the sterilizing light assists in acting on the wound to form the sterilizing effect.
In a preferred embodiment, the medical antimicrobial catheter further comprises a bactericidal coating 20 covering the periphery of the predetermined area 11 of the catheter body 10; during operation of the medical antimicrobial catheter, the catheter body 10 is inserted into the human body B such that the antimicrobial coating 20 is at the site of injury (between a and B in vitro). In this embodiment, the sterilization coating 20 is a catheter drug slow-release coating, and the sterilization coating 20 can continuously sterilize for a long time, thereby avoiding the bacterial reproduction in the sterilization interval period and achieving more thorough sterilization. By non-contact sterilization, disinfectants such as chlorhexidine, iodophor and the like do not need to be sprayed regularly.
In this embodiment, the germicidal light may combine with the germicidal chemicals to form a dual germicidal effect. The sterilizing light transmitted by the optical fiber 30 can sterilize thoroughly in the range near the wound, and incomplete sterilization caused by incomplete wiping or insufficient time is avoided.
The predetermined region 11 may be understood as a section of the catheter body 10 or a local space inside the catheter body 10, which predetermined region 11 corresponds to a target sterilization zone of the human body when in use, i.e. adjacent to the junction between the outside a and the inside B of the body, in conjunction with the attached drawings.
The outer diameter of the optical fiber 30 (light conducting fiber) in this embodiment is in the range of 0.09-3mm, and the material of the optical fiber 30 may be a glass fiber, a plastic fiber, a quartz fiber, a liquid core fiber, or the like. The outer surface of the optical fiber 30 is provided with a hydrophilic PVP cladding to protect the optical fiber from erosion by liquids such as water and body fluids.
During operation of the medical antimicrobial catheter, the medical antimicrobial catheter is inserted into a wound (e.g., scalp), the optical fiber 30 is placed into the predetermined region 11 of the catheter body 10, and the middle of the working end 32 is maintained to sterilize the wound.
In various applications of the medical antibacterial catheter, the catheter body 10 may be a drainage tube or a catheter as an interventional catheter.
The optical fiber 30 may be single or bundled, and as a whole, may be selected in different diameter ranges according to different application scenarios of the medical antibacterial catheter, for example, at least the catheter, the drainage tube, etc. can be inserted smoothly without affecting the fluid movement in the tube. Typically, the diameter of the fiber 30 is within 3000 microns. The bactericidal coating 20 is loaded with chemicals that can participate in sterilization, and for the carrier, hydrogel can be used. The chemical substances which can participate in sterilization are, for example, carvacrol (or raw materials, downstream derivatives thereof, etc.).
The chemical substance can be pre-dispersed in the carrier and then coated on the periphery of the predetermined area 11 by chemical grafting or physical coating, for example, the medical antibacterial catheter is a drainage tube, and a hydrogel coating loaded with the vitex polyphenol is added on the outer wall of the drainage tube by a grafting technology. During the working process of the medical antibacterial catheter, the medicine is released from the hydrogel layer in vivo along with time, and the hydrogel layer is degraded along with time in vivo. Specifically, the hydrogel releases the drug by swelling, and the drug release time is 1 to 7 hours (the drug is completely released after 7 hours).
The hydrogel drug-loaded (for example, the hydrogel layer loaded with the drug vitex polyphenol) is prepared by cross-linking konjac glucomannan prepared by using glutaraldehyde as a cross-linking agent and polyvinylpyrrolidone (PVP) to synthesize a semi-interpenetrating network hydrogel, soaking a section (the peripheral part of the predetermined area 11) of the catheter body 10 in a solution for 6 hours in the process of synthesizing the hydrogel, and forming a PVP hydrogel coating with a certain thickness on the catheter wall after drying. Then dissolving the drug in ethanol (or ether), soaking the catheter with the PVP hydrogel coating in the drug solution for 24 hours, and then carrying out vacuum drying to obtain the drug-loaded hydrogel coating. Wherein the polyvinylpyrrolidone (PVP) may be PVPK 30 Or PVPK 60 Or PVPK 90 。
Regarding the preparation of the hydrogel drug carrier, which can be done in a conventional manner, but in combination with the environment of body fluids, the following also provides a preferred solution, for example, in parts by weight, including:
200 parts of water for providing an aqueous reaction environment
1-5 parts of PVP, preferably 2 parts;
1-5 parts of konjac glucomannan, preferably 2 parts, and further preferably the weight ratio of PVP to konjac glucomannan is 1:1;
0.1-0.5 part, preferably 0.25 part of glutaraldehyde, and the glutaraldehyde can be prepared into an aqueous solution with the mass percentage concentration of 2-10, preferably 5%.
The hydrogel prepared by the preferred scheme has better performance, and maximum drug-loading rate and drug release amount. In this case, the maximum drug release amount can reach 70%.
There is no strict material limitation on the catheter body, and for example, a common silicone material may be used.
In this embodiment, the thickness of the bactericidal coating 20 is in the range of 0.001mm to 1 mm. It is understood that in the case of a coating thickness of less than 0.001mm, the hydrogel drug loading was insufficient; in the case of a slightly larger coating thickness, the use of the medical antimicrobial catheter may be compromised. Specifically, the crosslinker dosage is used to adjust the coating thickness of the antimicrobial coating 20. For example, when the thickness is insufficient, the amount of the crosslinking agent is increased or the soaking treatment is performed again; when the thickness is thicker, the cross-linking agent dosage is reduced.
Along the length direction of the catheter body, the coating area of the bactericidal coating 20 ranges from 2cm to 20cm, for example from 8 cm to 12cm, and in the case of 10cm, the catheter can cover 5cm in front and back of the catheter by taking the position where the catheter is inserted into a human body (between the outside A and the inside B).
To ensure the working end 32 functions, in one embodiment, referring to FIG. 1, the working end 32 of the optical fiber 30 (the tail of the optical fiber 30) is 0.1-10 cm in length, and the working end 32 has a diverging illumination direction.
The divergent illumination direction is at least to avoid unidirectional light emission, preferably to radiate in a spherical space, and may be achieved by adding a fluorescent substance to the material of the optical fiber 30 at the working end 32 and/or by providing a diffusely reflective outer surface at the working end.
Specifically, at the position of the working end 32 (tube-tail optical fiber 30) of the optical fiber 30, the core material of the optical fiber 30 is polished to destroy the total reflection in the core material of the optical fiber 30, so as to obtain a diffuse reflection core material, and if necessary, the light is uniformly scattered by combining with the added fluorescent material, so that the transmitted light is scattered at the tube tail. That is, the diffuse reflection core material-added fluorescent material may be doped in the material of the optical fiber 30, or may be formed on the surface, that is, the light-emitting layer 33, so as to realize a divergent irradiation direction. The added fluorescent substance may be, for example, pearl powder, glass beads, transparent ceramic beads, fluorescent agent, or the like.
To confirm the relative position of the catheter body 10 and the optical fiber 30, in one embodiment, at least one of the catheter body 10 and the optical fiber 30 is provided with a marker indicating the insertion depth of the two. It will be appreciated that the catheter body 10 and the optical fiber 30 may also be provided with cooperating stop structures to determine the relative position of the catheter body 10 and the optical fiber 30 such that the working end 32 of the optical fiber 30 reaches the predetermined region 11.
Referring to fig. 2, an embodiment of the present application further provides a medical antimicrobial catheter system, which includes the medical antimicrobial catheter according to the embodiments of the present application and a light source 40, wherein the light source 40 is optically connected to the optical fiber 30. Further, the light source 40 has an adjustable light emitting wavelength, and the light emitting wavelength at least includes 10nm to 420nm.
In this embodiment, the light source 40 is emitted by a light source emitter, which has a function of adjusting the light emitting wavelength and can emit ultraviolet light, violet light, and blue light. The light source emitter comprises a host 50 and a light source 40, wherein the host 50 can adjust power and light emitting wavelength of the light source, and an output end of the light source is connected with the driving end 31 of the optical fiber 30 through a light source connector 41.
An embodiment of the present application further provides a sterilization method, including using the medical antibacterial catheter system of the embodiments of the present application to complete the following steps: the catheter body 10 is inserted to a designated position, and the periphery of a preset area 11 of the catheter body 10 is covered with an antibacterial coating 20; extending the working end 32 of the optical fiber 30 into the catheter body 10 to the predetermined region 11; performing first-stage illumination on the bactericidal coating 20 by using the optical fiber 30, and maintaining the first time, wherein the wavelength of light irradiated in the first stage is 10-400 nm, and the time range of the first stage is 0.02-30min; ultraviolet light of 10 nm-400 nm can directly kill bacteria.
After the first stage irradiation, the second stage irradiation is performed on the sterilization coating 20 by using the optical fiber 30, and the second period of time is maintained, and the wavelength of the light irradiated at the second stage is 400nm to 420nm.
The time range of the second stage is not limited strictly, and may be the time period associated with the use of the catheter body 10, but the drug release is always performed in the early stage, and the synergy between the drug and the light sterilization can be achieved, and after a long time, the light sterilization effect can be maintained despite the fact that the drug release is completed.
In particular, since infection is most likely to occur just after intubation (when the body comes into contact with the outside world), bacteria in the light accessible site on the surface of the lesion are killed mainly by light irradiation in the first stage. It will be appreciated that in the first stage, the drug is also in a released state but not as a primary bactericidal means. After the first stage is finished, the second stage is sterilized by the combined action of the medicine and the light, after hidden bacteria are thoroughly killed (the light on the non-focus surface can reach the part), the sterile state of the wound surface is maintained by the continuous irradiation of the purple light, and the second stage is performed until the tube is pulled out.
The drug release time range is affected by the swelling ratio of the PVP hydrogel. Specifically, the PVP hydrogel releases the loaded drug by swelling, the main factor influencing the drug release amount is the swelling ratio of the hydrogel, and the higher the swelling ratio is, the faster the drug is released, and further the time range of the drug release is influenced.
In the second stage, the catechin polyphenols released from the germicidal coating 20, under the irradiation of light (blue light) with a wavelength around 405nm, generate ROS (reactive oxygen species) with the bacterial endogenous photosensitizer 1 O2、H 2 O 2 And various oxygen radicals) trigger a series of linked blue photochemical reactions. Excitation of bacterial endogenous photosensitizers by 405nm blue light via energy transfer and electron transfer to generate ROS, e.g. 1 O 2 、H 2 O 2 Oxidizing schizonepeta-phenol (namely, vitex polyphenol) with ROS (reactive oxygen species) such as various oxygen free radicals as oxidizing agents to generate thymoquinone and thymohydroquinone with blue light photosensitive characteristics and phototoxicity, wherein the thymoquinone and the thymohydroquinone respond to blue light with the same wave band, and a large amount of H is generated by using oxygen 2 O 2 ，H 2 O 2 Blue light photolysis occurs to produce OH, which induces bacterial DNA oxidative damage and destruction of the lipid layer of the membrane, resulting in bacterial death. Detected by in vitro sterilization experiments.
It will be appreciated that in the first stage, the surface is more bacteria, so the first stage uses uv sterilization to kill bacteria quickly. The subsequent second stage kills the residual bacteria and the subsequently generated bacteria to maintain the sterile state.
The application can quickly eliminate the planktonic bacteria forms of multiple drug-resistant gram-positive bacteria MRSA, gram-negative bacteria pseudomonas and acinetobacter baumannii, has the same bactericidal effect on a biomembrane in a mature period and a persistent bacterium in a dormant period, and does not induce bacteria to generate drug resistance. Tested at 7.5log CFU/mL (representing 10 per mL) 7.5 Individual colony), vitexin 0.2mg/mL (concentration of drug in mixed solution of drug and PVP), and wavelength 405nm,20J/cm 2 Under the condition of (2), the time for complete sterilization is 6min. It will be appreciated that the hydrogel continues to release nepeta-fragrance during degradation and use in a catheterThe purple light can always exist in the process of (1) to keep the sterilization effect.
All possible combinations of the technical features of the embodiments described above may not be described for the sake of brevity, but should be considered as being within the scope of the present disclosure as long as there is no contradiction between the combinations of the technical features. Features of different embodiments are shown in the same drawing, which is to be understood as also disclosing combinations of the various embodiments concerned.
The above-mentioned embodiments only express several embodiments of the present application, and the description thereof is more specific and detailed, but not construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application.
Claims (10)
1. Medical antimicrobial catheter, characterized in that it comprises:
a catheter body;
and one end of the optical fiber is a driving end and is provided with a light source connector, the other end of the optical fiber is a working end, and the length of the optical fiber at least can extend to a preset area of the catheter body in the catheter body.
2. The medical antimicrobial catheter of claim 1, further comprising a biocidal coating surrounding a predetermined area of the catheter body.
3. The medical antimicrobial catheter of claim 2, wherein the antimicrobial coating is a hydrogel layer loaded with carvacrol;
the hydrogel layer is coated on the periphery of the preset area in a chemical grafting or physical coating mode.
4. The medical antimicrobial catheter of claim 1, wherein the working end of the optical fiber has a length of 0.1 to 10cm and the working end has a divergent irradiation direction.
5. The medical antimicrobial catheter of claim 4, wherein the optical fiber material of the working end is doped with a fluorescent material and/or the working end has a diffusely reflective outer surface.
6. The medical antimicrobial catheter of claim 1, wherein at least one of the catheter body and the optical fiber is provided with a marking indicating the insertion depth of the catheter body and the optical fiber.
7. The medical antimicrobial catheter of claim 1, wherein the catheter body is an interventional catheter.
8. A medical antimicrobial catheter system, comprising:
a catheter body;
one end of the optical fiber is a driving end and is provided with a light source connector, the other end of the optical fiber is a working end, and the length of the optical fiber can at least extend to a preset area of the catheter body in the catheter body;
and the light source is connected with the optical fiber by adopting a light path.
9. The medical antimicrobial catheter system according to claim 8, wherein the light source has a tunable light emitting wavelength, and the light emitting wavelength is at least 10nm to 420nm.
10. The sterilization method is characterized by comprising the following steps:
inserting a catheter body to a designated location;
extending the working end of the optical fiber into the catheter body to a predetermined region;
and (4) performing illumination sterilization by using the optical fiber.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202111046360.1A CN115770347A (en) | 2021-09-07 | 2021-09-07 | Medical antibacterial catheter, medical antibacterial catheter system and sterilization method |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202111046360.1A CN115770347A (en) | 2021-09-07 | 2021-09-07 | Medical antibacterial catheter, medical antibacterial catheter system and sterilization method |
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| CN115770347A true CN115770347A (en) | 2023-03-10 |
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| CN202111046360.1A Pending CN115770347A (en) | 2021-09-07 | 2021-09-07 | Medical antibacterial catheter, medical antibacterial catheter system and sterilization method |
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