CN114225056A - Medical ultrasonic coupling patch - Google Patents
Medical ultrasonic coupling patch Download PDFInfo
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- CN114225056A CN114225056A CN202111629676.3A CN202111629676A CN114225056A CN 114225056 A CN114225056 A CN 114225056A CN 202111629676 A CN202111629676 A CN 202111629676A CN 114225056 A CN114225056 A CN 114225056A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K49/00—Preparations for testing in vivo
- A61K49/22—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations
- A61K49/222—Echographic preparations; Ultrasound imaging preparations ; Optoacoustic imaging preparations characterised by a special physical form, e.g. emulsions, liposomes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/42—Details of probe positioning or probe attachment to the patient
- A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
- A61B8/4281—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Veterinary Medicine (AREA)
- Acoustics & Sound (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
The invention belongs to the technical field of medical equipment, and particularly relates to a medical ultrasonic coupling patch. The medical coupling patch consists of hydrogel containing non-woven fabric. Under the specified size of the non-woven fabric, the introduction of the non-woven fabric can avoid causing adverse effects on ultrasonic imaging and ensure the imaging effect of the non-woven fabric. The non-woven fabric is embedded in the hydrogel, so that the mechanical property of the hydrogel is greatly improved, the hydrogel is not easy to break and deform during use, the imaging quality is not damaged, and the hydrogel has excellent stability. The coupling patch has clear ultrasonic image, high resolution, comfortable use body feeling and high stability.
Description
Technical Field
The invention belongs to the technical field of medical equipment, and particularly relates to a medical ultrasonic coupling patch.
Background
Ultrasound couplants are sound-conducting media used in ultrasound diagnostic procedures. In the ultrasonic diagnosis process, in order to obtain good imaging quality, an ultrasonic coupling medium is generally required to be filled between an ultrasonic probe and the skin, air between the probe and the skin is removed, and the influence of the air on sound wave transmission is eliminated. The good ultrasonic couplant has acoustic impedance matched with human skin and lower acoustic attenuation, and can smoothly discharge air to ensure that acoustic waves are smoothly transmitted at the interface of the probe and the skin, thereby improving the imaging quality. At present, the liquid couplant prepared based on carbomer is widely used clinically. The imaging device is widely used due to the advantages of low price, easy obtaining and good imaging effect. However, some of the disadvantages of liquid couplants cannot be neglected: in the diagnosis process, the skin surface to be detected needs to be smeared and cleaned after the diagnosis process is finished, so that the diagnosis efficiency and the treatment experience are influenced; in addition, the liquid couplant does not completely isolate the test site from the probe, risking cross-infection between patients. It is possible to solve the above problems by developing a solid-state ultrasonic couplant.
In recent years, ultrasound-coupled patch products made of hydrogels have emerged. The system has attracted wide attention because of comfortable use feeling and imaging convenience at special positions. However, the currently used solid coupling patch has poor mechanical properties, and is easy to deform or plastically deform during use, thereby causing certain influence on the ultrasonic effect. Therefore, it is necessary to develop a novel ultrasound coupling patch with good acoustic and mechanical properties.
The invention discloses a novel ultrasonic coupling patch. Consists of hydrogel containing non-woven fabric. Due to the introduction of the non-woven fabric, the mechanical property of the hydrogel is greatly improved, the hydrogel has good stability in the using process, and the hydrogel is not easy to break or generate plastic deformation. Under the condition of the size of the non-woven fabric specified by the invention, the non-woven fabric fibers can not diffract, reflect and attenuate sound waves, the influence of the introduction of the non-woven fabric on ultrasound is avoided, and the coupling patch has good acoustic performance. The coupling patch is simple in preparation process, comfortable in use body feeling and clear in ultrasonic imaging.
Disclosure of Invention
In order to solve the problems in the prior art, the invention provides the solid medical ultrasonic coupling patch which is convenient and sanitary to use, does not damage the probe, has high ultrasonic image quality and is low in cost.
The medical ultrasonic coupling patch provided by the invention consists of hydrogel containing hydrophilic non-woven fabric, and the hydrophilic non-woven fabric is embedded into the hydrogel to form a composite sheet consisting of the hydrogel and a hydrophilic non-woven fabric layer.
In the invention, the hydrophilic non-woven fabric is one or more of hydrophilic hot-rolled non-woven fabric, hydrophilic melt-blown non-woven fabric and hydrophilic spun-bonded non-woven fabric;
in the present invention, the nonwoven fabric has a fiber diameter of less than 50 μm, for example, 5 nm to 50 μm, as a standard, without affecting the effect of ultrasonic imaging at a specific frequency.
In the present invention, the nonwoven fabric may be a single layer or a plurality of layers.
In the invention, the hydrogel can be any gel substance with good acoustic performance;
according to the invention, the hydrogel comprises the following components in parts by weight:
deionized water: 100 parts of (A);
water-soluble polymer: 0.001 to 30 parts, preferably 1 to 30 parts of a water-soluble polymer;
glycerol: 0-30 parts, preferably 2-30 parts of glycerol;
auxiliary substances: 0 to 20 parts, preferably 2 to 20 parts of auxiliary substances.
In the present invention, the water-soluble polymer may be a natural polymer, a synthetic polymer or a mixture thereof.
In the invention, the natural polymer can be selected from carrageenan, sodium alginate, cellulose, gelatin, agar, collagen, gellan gum, xanthan gum, chitosan and the like; the synthetic polymer is selected from polyacrylamide, polyacrylic acid, sodium polyacrylate, poly N-hydroxyethyl propionamide, sodium polyacrylate, polyethylene glycol and the like.
In the invention, the auxiliary substance can be one or more of a humectant, a preservative, an antibacterial agent, a coloring agent, a flavoring agent, a lubricant, a cross-linking agent and an initiator.
The invention provides a preparation method of a medical ultrasonic coupling patch, which comprises the following specific steps:
(1) taking a certain amount of deionized water, water-soluble polymers or water-soluble polymer monomers, heating and stirring to obtain a homogeneous transparent precursor solution;
(2) pouring the precursor solution obtained in the step (1) into a mold paved with non-woven fabrics in advance, and firstly crosslinking the natural macromolecules to form gel by a cooling or cross-linking agent adding method; then, ultraviolet irradiation is carried out to initiate monomer in-situ polymerization to form a synthetic polymer network (or the effect is realized by directly adding the synthetic polymer and a cross-linking agent, the effect is the same) to obtain the hydrogel of the composite non-woven fabric, and the ultrasonic coupling patch is obtained by processes of cutting, packaging and the like.
In the invention, the hydrogel is ensured to have sufficient acoustic performance by adjusting the solid content and the glycerol content of the hydrogel, the imaging is ensured to be clear and stable, the requirements related to YY 0299-2008 are met, the acoustic performance is good, and the ultrasonic conduction effect is good.
In the invention, the non-woven fabric with hydrophilicity and proper size is compounded with the hydrogel, so that the non-woven fabric with hydrophilicity and the hydrogel are compounded well. The non-woven fabric with proper size can not generate the influences of diffraction, reflection, attenuation and the like on the ultrasound under the ultrasound diagnosis frequency, the ultrasound coupling paste has clear imaging and high resolution;
the solid medical ultrasonic coupling patch provided by the invention does not adhere to skin and an ultrasonic probe after being used, is convenient and sanitary to use, and has no irritation or allergy.
Compared with the prior art, the invention has the beneficial effects that:
(1) the coupling patch provided by the invention is compounded with non-woven fabrics with proper sizes. The coupling paste has excellent mechanical property, and can not generate breakage and plastic deformation under the diagnosis condition. Has low friction and good wettability, and can be tightly attached to skin. As shown in the following figure 1, the sliding friction force generated by the 0.2Kg metal weight on the surface of the coupling paste is only 0.3N; the coupling patch can bear a tensile force of up to 0.8MPa (800 kPa).
(2) The ultrasonic coupling patch provided by the invention can completely isolate the detection part from the probe, and avoids the risk of cross infection among patients caused by using a liquid coupling agent. And has comfortable use feeling compared with liquid coupling agent.
(3) The coupling patch provided by the invention has low cost, and the used raw materials are all common and easily available raw materials. The coupling patch is beneficial to improving the current situation that the price of the existing coupling patch product is high, and the pressure of a patient is relieved.
(4) The coupling paste provided by the invention is simple in preparation method and strong in repeatability. The preparation process does not need to use organic solvent, does not need to take time and prepare in multiple steps, and has high gelling speed and high yield. Various common functional additives can be conveniently added into the raw materials to endow the coupling patch with various required functions.
Drawings
Fig. 1 is an imaging diagram of the liquid couplant of example 1.
Fig. 2 is an imaging diagram of the liquid couplant of example 2.
Fig. 3 is an imaging diagram of the liquid couplant of embodiment 3.
Fig. 4 is an imaging diagram of the liquid couplant of example 4.
Fig. 5 is an imaging diagram of the liquid couplant of example 5.
Fig. 6 is an imaging diagram of the liquid couplant of example 6.
Detailed Description
The present invention is further described in detail below by way of specific examples, but the scope of protection is not limited to the examples described below, which are exemplary and not limiting.
Example 1
According to the following mixture ratio, 100 parts of deionized water, 2.5 parts of carrageenan, 15 parts of acrylamide monomer, 0.03 part of cross-linking agent N' N-methylene bisacrylamide and 0.52 part of initiator 2-hydroxy-4- (2-hydroxyethoxy) -2-methyl propiophenone are heated and homogenized to form transparent gel precursor solution. Mixing 25g/m2The method comprises the following steps of paving a single-layer hydrophilic PEPP non-woven fabric into a mold, pouring a precursor solution into the mold, cooling to obtain carrageenan-crosslinked hydrogel, initiating in-situ polymerization of acrylamide monomers by ultraviolet irradiation to obtain the carrageenan/polyacrylamide double-network hydrogel loaded with the single-layer hydrophilic PEPP non-woven fabric, cutting and packaging to obtain the ultrasonic coupling patch.
A human tissue phantom is imaged by using the liquid couplant and the prepared ultrasonic coupling patch respectively, as shown in figure 1. The similarity between the two images is calculated to be up to 96.7% by adopting a mean value hash algorithm, and the similarity between the image and an image obtained by using the liquid couplant is calculated to be 84.4% by adopting a histogram comparison algorithm (the similarity between the image and the image obtained by using the two algorithms under the same condition of a certain commercially available coupling paste is 86.3% and 82.8%, respectively).
Example 2
According to the following mixture ratio, 100 parts of deionized water, 2.5 parts of carrageenan, 15 parts of acrylamide monomer, 0.03 part of cross-linking agent N' N-methylene bisacrylamide and 0.52 part of initiator 2-hydroxy-4- (2-hydroxyethoxy) -2-methyl propiophenone are heated and homogenized to form transparent gel precursor solution. 3 layers of 25g/m2The preparation method comprises the steps of paving the hydrophilic PEPP non-woven fabric into a mold, pouring a precursor solution into the mold, cooling to obtain carrageenan-crosslinked hydrogel, irradiating by ultraviolet light to initiate in-situ polymerization of acrylamide monomers in the hydrogel to obtain carrageenan/polyacrylamide double-network hydrogel loaded with 3 layers of hydrophilic PEPP non-woven fabric, cutting and packaging to obtain the ultrasonic coupling patch.
The prepared coupling patch and the liquid couplant are used for imaging a human tissue phantom, as shown in figure 2. The similarity of the imaging graphs of the two images is calculated by adopting a mean hash algorithm and a histogram comparison algorithm and is respectively 80.2 percent and 98.4 percent.
Example 3
According to the following mixture ratio, 100 parts of deionized water, 2.5 parts of carrageenan, 15 parts of acrylamide monomer, 0.03 part of cross-linking agent N' N-methylene bisacrylamide and 0.52 part of initiator 2-hydroxy-4- (2-hydroxyethoxy) -2-methyl propiophenone are heated and homogenized to form transparent gel precursor solution. 8 layers of 25g/m2The preparation method comprises the steps of paving the hydrophilic PEPP non-woven fabric into a mold, pouring a precursor solution into the mold, cooling to obtain carrageenan-crosslinked hydrogel, irradiating by ultraviolet light to initiate in-situ polymerization of acrylamide monomers in the hydrogel to obtain carrageenan/polyacrylamide double-network hydrogel loaded with 8 layers of hydrophilic PEPP non-woven fabric, cutting and packaging to obtain the ultrasonic coupling patch.
The prepared coupling patch and the liquid couplant are used for imaging a human tissue phantom, as shown in figure 3. The similarity of the two imaging images is calculated by a histogram comparison algorithm and is 82.8 percent.
Example 4
Taking 100 parts of deionized water according to the following mixture ratio2.5 parts of carrageenan, 15 parts of acrylamide monomer, 0.03 part of cross-linking agent N' N-methylene bisacrylamide and 0.52 part of initiator 2-hydroxy-4- (2-hydroxyethoxy) -2-methyl propiophenone, and heating and homogenizing to form a transparent gel precursor solution. Selecting the standard of 30g/m2And a hydrophilic nonwoven fabric (hot-rolled nonwoven fabric, 30 g/m) composed of 30%4080+70% terylene2) The carrageenin/polyacrylamide double-network hydrogel loaded with 4080/terylene just-like cloth is obtained by laying the carrageenan/polyacrylamide double-network hydrogel into a mould, pouring a precursor solution into the mould, cooling to obtain carrageenan-crosslinked hydrogel, and initiating in-situ polymerization of acrylamide monomers in the hydrogel by ultraviolet irradiation, and cutting and packaging to obtain the ultrasonic coupling patch.
The prepared coupling patch and the liquid couplant are used for imaging a human tissue phantom, as shown in figure 4. The similarity of the imaging graphs of the two images is calculated by adopting a mean hash algorithm and a histogram comparison algorithm and is respectively 95.4 percent and 98.4 percent.
Example 5
According to the following mixture ratio, 100 parts of deionized water, 2.5 parts of carrageenan, 15 parts of acrylamide monomer, 0.03 part of cross-linking agent N' N-methylene bisacrylamide and 0.52 part of initiator 2-hydroxy-4- (2-hydroxyethoxy) -2-methyl propiophenone are heated and homogenized to form transparent gel precursor solution. A monolayer of 40g/m2The hydrophilic PEPP non-woven fabric is laid in a mould, a precursor solution is poured into the mould, the hydrogel crosslinked by carrageenan is obtained after cooling, and then the acrylamide monomer is initiated to be polymerized in situ by ultraviolet irradiation to obtain the load of 40g/m2The carrageenan/polyacrylamide double-network hydrogel of the hydrophilic PEPP non-woven fabric is cut and packaged to obtain the ultrasonic coupling patch.
The prepared coupling patch and the liquid couplant are used for imaging a human tissue phantom, as shown in fig. 5. The similarity of the imaging graphs of the two images is calculated by adopting a mean hash algorithm and a histogram comparison algorithm, and is respectively 96.7 percent and 90.6 percent.
Example 6
According to the following mixture ratio, 100 parts of deionized water, 2.5 parts of carrageenan, 15 parts of acrylamide monomer and a crosslinking agent N' N-methylene-bis-propylene0.03 portion of amide and 0.52 portion of initiator 2-hydroxy-4- (2-hydroxyethoxy) -2-methyl propiophenone, and heating and homogenizing to form a transparent gel precursor solution. The selected components are hydrophobic PP non-woven fabric (hot-rolled non-woven fabric, 30 g/m)2) The carrageenin/polyacrylamide double-network hydrogel loaded with 4080/terylene just-like cloth is obtained by laying the carrageenan/polyacrylamide double-network hydrogel into a mould, pouring a precursor solution into the mould, cooling to obtain carrageenan-crosslinked hydrogel, and initiating in-situ polymerization of acrylamide monomers in the hydrogel by ultraviolet irradiation, and cutting and packaging to obtain the ultrasonic coupling patch.
The prepared coupling patch and the liquid couplant are used for imaging a human tissue phantom, as shown in fig. 6. The similarity of the two imaging graphs is calculated by adopting a mean hash algorithm and a histogram comparison algorithm, and is respectively 76.7 percent and 79.7 percent.
The above is only a preferred embodiment of the present invention, and it should be noted that the above preferred embodiment is not a limitation of the present invention, and the protection scope of the present invention should be subject to the scope defined by the claims. For the technical field, certain improvements and modifications can be made without departing from the spirit and scope of the invention, such as addition of various common functional additives, such as metal salts, cross-linking agents, humectants, antibacterial agents, preservatives, disinfectants, coloring agents, flavoring agents, and the like; such modifications and variations are considered to be within the scope of the present invention, as the gel-coupled patches are prepared by different processes with similar structures.
Claims (10)
1. A medical ultrasonic coupling patch is characterized by consisting of hydrogel containing hydrophilic non-woven fabric, wherein the hydrophilic non-woven fabric is embedded into the gel to form a composite sheet consisting of the hydrogel and a hydrophilic non-woven fabric layer.
2. The medical ultrasound coupling patch according to claim 1, wherein the hydrophilic non-woven fabric is one or more of a hydrophilic hot-rolled non-woven fabric, a hydrophilic melt-blown non-woven fabric and a hydrophilic spun-bonded non-woven fabric.
3. The medical ultrasound coupling patch according to claim 1, wherein the hydrophilic nonwoven fabric has a fiber diameter of 5 nm to 50 μm.
4. The medical ultrasound coupling patch according to claim 1, wherein the hydrophilic non-woven fabric is one or more layers.
5. The medical ultrasound coupling patch according to claim 1, wherein the hydrogel comprises the following components in parts by weight:
deionized water: 100 parts of (A);
water-soluble polymer: 0.001-30 parts;
glycerol: 0-30 parts of a solvent;
auxiliary substances: 0 to 20 parts.
6. The medical ultrasound coupling patch according to claim 5, wherein the hydrogel comprises the following components in parts by weight:
deionized water: 100 parts of (A);
water-soluble polymer: 1-30 parts;
glycerol: 2-30 parts of a solvent;
auxiliary substances: 2-20 parts.
7. The medical ultrasound coupling patch according to claim 6, wherein the water-soluble polymer is a natural polymer, a synthetic polymer or a mixture thereof.
8. The medical ultrasound coupling patch according to claim 7, wherein the natural polymer is selected from carrageenan, sodium alginate, cellulose, gelatin, agar, collagen, gellan gum, sesbania gum, xanthan gum, chitosan; the synthetic polymer is selected from polyacrylamide, polyacrylic acid, sodium polyacrylate, poly N-hydroxyethyl propionamide, sodium polyacrylate and polyethylene glycol.
9. The medical ultrasound coupling patch according to claim 7, wherein the auxiliary substance is one or more of a humectant, a preservative, an antimicrobial agent, a colorant, a flavoring agent, a lubricant, a cross-linking agent, an initiator.
10. A method for preparing a medical ultrasound coupling patch according to any one of claims 1 to 9, comprising the following steps:
(1) taking a certain amount of deionized water, water-soluble polymers or water-soluble polymer monomers, heating and stirring to obtain a homogeneous transparent precursor solution;
(2) pouring the precursor solution obtained in the step (1) into a mold paved with non-woven fabrics in advance, and firstly crosslinking the natural macromolecules to form gel by a cooling or cross-linking agent adding method; and then ultraviolet irradiation is carried out to initiate in-situ polymerization of the monomer to form a synthetic polymer network, hydrogel of the composite non-woven fabric is obtained, and the ultrasonic coupling patch is obtained after cutting and packaging.
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| CN102599937A (en) * | 2012-04-06 | 2012-07-25 | 蔡信东 | Convenient medical couplant patch and preparation method thereof |
| CN105536005A (en) * | 2016-01-06 | 2016-05-04 | 深圳市敏浩科技有限公司 | Solid medical ultrasound coupling patch and preparing method thereof |
| CN208876582U (en) * | 2017-12-29 | 2019-05-21 | 珠海全德科技有限公司 | A kind of medical supersonic coupled patch |
| CN210044026U (en) * | 2018-12-25 | 2020-02-11 | 苏州乐泰医疗科技有限公司 | Medical ultrasonic coupling plaster |
| CN214181160U (en) * | 2021-01-08 | 2021-09-14 | 沈阳赛镝医疗器械有限公司 | Hydrophilic gel skeleton coupling paster |
| CN113652050A (en) * | 2021-06-30 | 2021-11-16 | 广东粤港澳大湾区国家纳米科技创新研究院 | Hydrogel film, preparation method thereof and ultrasonic coupling patch |
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2021
- 2021-12-28 CN CN202111629676.3A patent/CN114225056A/en active Pending
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|---|---|---|---|---|
| CN102599937A (en) * | 2012-04-06 | 2012-07-25 | 蔡信东 | Convenient medical couplant patch and preparation method thereof |
| CN105536005A (en) * | 2016-01-06 | 2016-05-04 | 深圳市敏浩科技有限公司 | Solid medical ultrasound coupling patch and preparing method thereof |
| CN208876582U (en) * | 2017-12-29 | 2019-05-21 | 珠海全德科技有限公司 | A kind of medical supersonic coupled patch |
| CN210044026U (en) * | 2018-12-25 | 2020-02-11 | 苏州乐泰医疗科技有限公司 | Medical ultrasonic coupling plaster |
| CN214181160U (en) * | 2021-01-08 | 2021-09-14 | 沈阳赛镝医疗器械有限公司 | Hydrophilic gel skeleton coupling paster |
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