CN114052004A - Tissue fixation treatment device and operation method thereof - Google Patents
Tissue fixation treatment device and operation method thereof Download PDFInfo
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- CN114052004A CN114052004A CN202010750243.2A CN202010750243A CN114052004A CN 114052004 A CN114052004 A CN 114052004A CN 202010750243 A CN202010750243 A CN 202010750243A CN 114052004 A CN114052004 A CN 114052004A
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- 238000000034 method Methods 0.000 title claims abstract description 28
- 239000000834 fixative Substances 0.000 claims abstract description 87
- 230000002093 peripheral effect Effects 0.000 claims abstract description 64
- SXRSQZLOMIGNAQ-UHFFFAOYSA-N Glutaraldehyde Chemical compound O=CCCCC=O SXRSQZLOMIGNAQ-UHFFFAOYSA-N 0.000 claims description 35
- 241001465754 Metazoa Species 0.000 claims description 28
- 239000003795 chemical substances by application Substances 0.000 claims description 12
- 230000002572 peristaltic effect Effects 0.000 claims description 10
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 claims description 9
- 230000008878 coupling Effects 0.000 claims description 9
- 238000010168 coupling process Methods 0.000 claims description 9
- 238000005859 coupling reaction Methods 0.000 claims description 9
- 239000004033 plastic Substances 0.000 claims description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 5
- 238000001356 surgical procedure Methods 0.000 claims description 4
- 229910001220 stainless steel Inorganic materials 0.000 claims description 3
- 239000010935 stainless steel Substances 0.000 claims description 3
- 239000002699 waste material Substances 0.000 claims description 3
- 238000012545 processing Methods 0.000 claims description 2
- 239000012530 fluid Substances 0.000 claims 1
- 210000001519 tissue Anatomy 0.000 description 110
- 210000003516 pericardium Anatomy 0.000 description 23
- 230000008569 process Effects 0.000 description 15
- 241000283690 Bos taurus Species 0.000 description 7
- 230000000694 effects Effects 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
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- 229910000589 SAE 304 stainless steel Inorganic materials 0.000 description 3
- 238000004140 cleaning Methods 0.000 description 3
- 230000006378 damage Effects 0.000 description 3
- 230000036541 health Effects 0.000 description 3
- 210000003709 heart valve Anatomy 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 230000000451 tissue damage Effects 0.000 description 3
- 231100000827 tissue damage Toxicity 0.000 description 3
- 239000012620 biological material Substances 0.000 description 2
- 238000004132 cross linking Methods 0.000 description 2
- 230000007613 environmental effect Effects 0.000 description 2
- 230000005847 immunogenicity Effects 0.000 description 2
- 239000012535 impurity Substances 0.000 description 2
- 230000001788 irregular Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- 229920004934 Dacron® Polymers 0.000 description 1
- 241000283073 Equus caballus Species 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
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- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000018578 heart valve disease Diseases 0.000 description 1
- 230000001744 histochemical effect Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 239000005020 polyethylene terephthalate Substances 0.000 description 1
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- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N1/00—Preservation of bodies of humans or animals, or parts thereof
- A01N1/02—Preservation of living parts
- A01N1/0205—Chemical aspects
- A01N1/0231—Chemically defined matrices, e.g. alginate gels, for immobilising, holding or storing cells, tissue or organs for preservation purposes; Chemically altering or fixing cells, tissue or organs, e.g. by cross-linking, for preservation purposes
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- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Dentistry (AREA)
- General Health & Medical Sciences (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Environmental Sciences (AREA)
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Abstract
The invention relates to a tissue fixing treatment device and an operation method thereof, and the tissue fixing treatment device comprises a fixative solution container, a container cover body, a plurality of hanging rods and a plurality of fixing devices, wherein the fixative solution container is provided with an opening at the upper part, two ends of the hanging rods are fixed on two opposite side edges of the opening, the fixing devices comprise a peripheral frame and a tissue connecting component, the fixing devices are vertically suspended in the fixative solution container through the hanging rods, and the tissue connecting component fixes tissues on the peripheral frame.
Description
Technical Field
The invention relates to the field of artificial heart valve biological tissue fixation, in particular to a device used in the process of fixing animal pericardial tissue by glutaraldehyde.
Background
Valvular heart disease has a high mortality rate, and valve replacement surgery is an effective means for treating such diseases at present. The valves used in clinical replacement surgery are mainly mechanical and biological valves. The mechanical valve has high durability and poor tissue compatibility, and needs long-term anticoagulation treatment after being implanted into a human body, otherwise, thrombus is easily generated. The biological valve replacement has the characteristics of no need of lifelong administration of anticoagulant, low immunogenicity and the like, so that the use amount of the biological valve replacement is increased year by year. The same valve, as a biological valve, has good tissue compatibility, but limited source and poor durability, and the clinical application of the same valve is limited due to the defects. The heterogeneous biological valve is a biological valve which is widely applied clinically, and the biochemical treatment of biological tissues is the main research content of the heterogeneous biological valve at home and abroad at present. There are many biological materials from which the heterologous valve is made, such as porcine or bovine pericardium. The bovine pericardium is a biological material with wide source, low immunogenicity and good histocompatibility. In recent years, with the development of tissue engineering, the strength of tissues and the service life of implanted tissues of the bovine pericardium treated by glutaraldehyde are obviously improved, the stretching force is obviously superior to that of the self pericardium tissues, and the bovine pericardium has wide sources and is easy to shape and suture. Animal pericardium tablet (such as cattle pericardium tablet) is gradually used alone or combined with dacron tablet and other materials for treating various congenital or acquired cardiovascular diseases.
The animal pericardium treatment process comprises the process steps of collecting animal pericardium, cleaning pericardium tissue, fixing the pericardium, cutting the pericardium, selecting the pericardium, storing the pericardium, transporting and using the pericardium and the like, wherein the fixing process is particularly important for fixing the shape of the animal pericardium. Tissue fixation refers to the structural stabilization of tissue by exposure to a fixative solution (a fixative such as glutaraldehyde). When the glutaraldehyde fixing treatment is carried out, animal pericardial tissue needs to be soaked in glutaraldehyde solution in a fully unfolded form for fixing, and the unfolding state of the animal pericardial tissue needs to be controlled by a tissue fixing device. In the traditional method, animal pericardial tissue can be flatly placed in a stainless steel tray for fixation, and a frame can be independently used for pressing the animal pericardial tissue. However, if the tissue is fixed in a folded state or creased, all of these appearances will be "permanently" stabilized. Therefore, such a process has the following problems: 1) in the fixing process, animal pericardial tissue is not easy to be completely unfolded and easily generates folds, the finished product rate of the final animal pericardial product is influenced, and the effective area for fixing the animal pericardial tissue is small; 2) the efficiency of animal pericardium fixing treatment is low; 3) glutaraldehyde solutions are easily volatilized under open container storage conditions, causing damage to the environment and operator health.
The problem to be solved in the art is to provide a tissue fixing treatment device which can fix animal pericardial tissue with irregular shape, can realize complete tissue expansion by randomly adjusting the length of a tissue fixing clamp, and meets the requirement that a fixing agent solution container is provided with a cover.
The above statements in the background are merely intended to facilitate a thorough understanding of the present disclosure (including the technical means used, technical problems solved and technical advantages brought about) and should not be taken as an acknowledgement or any form of suggestion that this information forms part of the prior art already known to a person skilled in the art.
Disclosure of Invention
In view of the shortcomings of the prior art, the invention aims to provide a tissue fixing treatment device which can be used by an operator to fix animal pericardial tissue with irregular shape in the animal pericardial fixing process, can realize complete expansion of the animal pericardial tissue by randomly adjusting the length of a tissue fixing clamp and meets the requirement that a fixing agent solution container is provided with a cover body.
Another object of the present invention is to provide a peripheral frame capable of flattening and fixing animal pericardial tissue, and vertically suspending the peripheral frame in a fixative solution container filled with fixative solution, so as to effectively fix and treat dozens of animal pericardial tissues at the same time, avoid tissue damage caused by mutual adhesion of tissues, and ensure good fixation effect.
It is another object of the present invention to provide a method of operating a tissue fixation device so that tissue can be conveniently and quickly retained in the tissue fixation device.
To achieve the above object, the present invention provides a tissue fixing treatment device comprising a fixative solution container having an opening at an upper portion, a container cover, a plurality of hanging bars having both ends fixed to opposite sides of the opening, and a plurality of fixing means including a peripheral frame and a tissue connecting member vertically suspended in the fixative solution container by the hanging bars, the tissue connecting member fixing the tissue to the peripheral frame.
Preferably, a plurality of through holes are formed in each of two opposite side edges of the opening of the fixative solution container, the through holes in the two opposite side edges are opposite to each other in pairs and are coaxial, and two ends of each hanging rod are inserted into the two opposite through holes and are fixed in the two opposite through holes respectively.
Preferably, each hanging rod is provided with a plurality of hooks.
Preferably, the peripheral frame is sized to fit within the interior of the fixative solution container so that the fixation device can be fully inserted into the fixative solution container.
Preferably, the internal space defined by the peripheral frame is a space for tissue fixation treatment.
Preferably, the peripheral frame is provided with a fixing clamping groove for hanging the peripheral frame on the hook.
Preferably, the peripheral frame is provided with a plurality of connecting through holes so that the tissue connecting member is fixed on the peripheral frame.
Preferably, the tissue connecting member comprises a tissue fixation clamp and a clamp holder.
Preferably, the tissue fixation clamp comprises a clip or hook.
Preferably, the clamp fixer comprises a connecting band and a fixing buckle, or comprises a screw and a nut.
Preferably, the clip fixing means is coupled to the tissue fixing clip by means of coupling through-holes formed in the peripheral frame, and the corresponding tissue fixing clip is coupled to the peripheral frame, and the coupling band or the screw is adjustable in length within the peripheral frame within its respective length range.
Preferably, a blank label is arranged on the outer wall of the fixative solution container.
Preferably, the container top is provided with a handle.
Preferably, the hook is S-shaped or Ω -shaped.
Preferably, the fixative solution container can be further provided with a circulating system, the circulating system comprises a pipeline connected outside the fixative solution container and a peristaltic pump connected to the pipeline, and the fixative solution is circulated by the pipeline driven by the peristaltic pump, so that the fixative solution keeps fluidity during the fixation treatment and the concentration balance of the fixative is maintained.
Preferably, a tap communicating with the inside is provided at a lower portion of a sidewall of the fixer solution container, and the fixer solution can be discharged through the tap after the fixing process operation is completed.
Preferably, the peripheral frame and the hanging rod are made of medical plastic or medical stainless steel materials.
Preferably, the tissue comprises animal pericardial tissue and is used to prepare a prosthetic valve for valve replacement surgery.
Preferably, the fixative solution comprises glutaraldehyde and isopropanol.
Preferably, the internal dimensions of the fixative solution container are 45cm long, 30cm wide and 30cm high, and the wall thickness of the fixative solution container is 4-8 mm.
The present invention also provides a method of operating the tissue fixation treatment device, comprising the steps of securing tissue to a peripheral frame by a tissue attachment member; sequentially installing the peripheral frame with the tissue on a hanging rod in a fixing agent solution container, wherein a glutaraldehyde solution is filled in the fixing agent solution container, the concentration range of the glutaraldehyde solution is from 0.20% to 0.625%, and the pH value of the glutaraldehyde solution is 7.3-7.5; maintaining the tissue in glutaraldehyde solution at room temperature for a period of 2 days to 2 weeks; until the tissue is completely cross-linked to complete the fixation, the peripheral frame is removed from the fixative solution container, and the tissue is then removed from the peripheral frame.
Preferably, during the tissue fixation process, an external peristaltic pump is turned on to ensure the fixative solution to flow circularly at a flow rate of 0.1-2L/min.
Preferably, after the fixation is completed, a water tap is opened, and the used fixative solution is collected in a waste liquid tank for treatment.
Preferably, the glutaraldehyde solution has a concentration of 0.5% and the glutaraldehyde solution has a pH of 7.4, and the tissue is maintained in the glutaraldehyde solution for 2 days at a temperature of 20 ℃.
Preferably, the flow rate of the fixative solution is 1.6L/min.
The invention has the beneficial effects that:
1. the peripheral frame can be fixed with the tissue exhibition flat, keeps vertical the hanging in the box that is full of stationary liquid with the peripheral frame, and the advantage is convenient to use, and the process is stable, can effectively fix the processing several tens of animal pericardium tissues simultaneously, and avoids the tissue to paste each other and cause the tissue damage, guarantees to reach good fixed effect, promotes the treatment effeciency, satisfies security and practicality.
2. The fixer solution container is in a completely sealed state after being covered with the container cover body, so that the glutaraldehyde or isopropanol solution in the fixer solution container is prevented from volatilizing, and the harm to the environment and the health of operators is avoided.
3. The fixative solution container is provided with a circulation system to maintain the fluidity of the fixative solution during the fixation treatment, maintain the concentration balance of the fixative, and maintain the concentration of the fixative solution at a target level, thereby positively affecting the effect of the tissue fixation treatment. In addition, the circulating system is arranged, so that impurities can be prevented from being attached to and remained on tissues or being deposited at the bottom of the fixative solution container in the fixing treatment process, and the fixing agent solution container is convenient to clean and maintain.
4. The fixing agent solution container is also provided with a faucet, and the fixing agent solution can be discharged through the faucet after the fixing treatment operation is completed, so that the situation that glutaraldehyde is spilled due to pouring of the fixing agent solution is completely avoided, the dangerous occurrence frequency and the severity are reduced, and the fixing agent solution container has the advantages of simple structure, quickness, convenience, safety and environmental friendliness.
Drawings
Fig. 1 is a schematic view of a fixative solution container and a container cover of a tissue fixation treatment device according to an exemplary embodiment of the present invention.
Fig. 2 is a schematic view of a fixation device structure of a tissue fixation treatment device according to an exemplary embodiment of the present invention.
It is to be understood that the appended drawings are not to scale, but are merely drawn with appropriate simplifications to illustrate various features of the basic principles of the invention. Specific design features of the invention disclosed herein, including, for example, specific dimensions, orientations, locations, and configurations, will be determined in part by the particular intended application and use environment.
In the several figures of the drawings, identical or equivalent parts are referenced with the same reference numerals.
Description of reference numerals:
1. fixative solution container
2. Through hole
3. Hanging rod
4. Hook for hanging articles
5. Container cover
6. Handle (CN)
7. Blank label
8. Peristaltic pump
9. Pipeline
10. Water tap
20. Fixing device
21. Peripheral frame
22. Fixing clamp groove
23. Clamp apparatus
24. Connecting belt
25. Fixing buckle
26. Tissue of
27. Connecting through hole
100. A tissue fixation treatment device.
Detailed Description
Exemplary embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
FIG. 1 is a schematic view of a fixative solution container and container cap configuration of a tissue fixation treatment device according to an exemplary embodiment of the present invention; fig. 2 is a schematic view of a fixation device structure of a tissue fixation treatment device according to an exemplary embodiment of the present invention.
Referring to fig. 1, there is provided a tissue fixing treatment device 100 for the present invention, which comprises a fixative solution container 1, a container cap 5 and a fixing means 20 (to be described in detail later), the fixative solution container 1 and the container cap 5 being made of medical plastic or medical 304 stainless steel, and being able to resist corrosion. The fixative solution container 1 is in a completely sealed state after being covered by the container cover body 5, thereby preventing the glutaraldehyde or isopropanol solution in the fixative solution container 1 from volatilizing and causing damage to the environment and the health of operators.
The whole fixer solution container 1 is cuboid, an opening is formed in the upper portion of the fixer solution container, a plurality of through holes 2 are formed in each of two opposite side edges of the opening, the through holes 2 in the two opposite side edges are opposite and coaxial, therefore, two ends of the hanging rod 3 are ensured to be inserted into the two opposite through holes 2 respectively, and the end portion of the hanging rod 3 is matched with the through hole 2 in the opening of the fixer solution container 1, so that the hanging rod 3 can be fixed in the through hole. The shape of the through-hole 2 may be a circle, but the present invention is not limited thereto, and the shape of the through-hole 2 may also be an ellipse, a polygon, or the like.
The inside dimensions of the fixative solution container 2 are 45cm long, 30cm wide and 30cm high, and the wall thickness of the fixative solution container 1 is 4 to 8mm, preferably 4 mm.
As shown in fig. 1, the opening of the fixative solution container 1 is rectangular, and a plurality of through holes 2 are provided on each of two longer sides of the rectangular opening, the through holes 2 on the two longer sides being opposed to each other and coaxial two by two. However, the present invention is not limited thereto, and a plurality of through holes may be provided on each of the two shorter sides of the rectangular opening of the fixer solution container 1. The opening of the fixative solution container 1 may also be square.
Each hanging rod 3 is provided with two hooks 4, and the hooks 4 are connected with fixing clamping grooves 22 (to be described in detail later) on the peripheral frame 21, so that the fixing device 20 is vertically suspended in the fixative solution container 1 and cannot move. Wherein, the hanging rod 3 is made of medical plastic or medical 304 stainless steel. The number of hooks 4 is not limited to two, and may be set to be greater than two according to actual requirements. The hooks 4 may be S-shaped, omega-shaped, etc., depending on the number of tissues to be fixed and the interval of the through holes 2 on each side. The peripheral frame 21 of the fixing device 20 is hung by the hook 4, dozens of pieces of animal pericardial tissues can be effectively fixed and processed at the same time, tissue damage caused by mutual adhesion of the tissues is avoided, and a good fixing effect is guaranteed.
The container cover body 5 is provided with a handle 6, which is convenient for opening and closing the container cover body 5. The number of the handles 6 may be one or two.
The blank label 7 is arranged on the outer wall of the fixative solution container 1, so that an operator can conveniently note related information of the fixative solution and the fixed tissue, such as the name and the concentration of the fixative solution, the source of the tissue and the like, and the traceability requirement is met.
Referring to fig. 2, the fixation device 20 includes a peripheral frame 21 and a tissue 26 connecting member, wherein the peripheral frame 21 is made of medical plastic or medical 304 stainless steel, and the peripheral frame 21 has a generally rectangular shape with a size corresponding to the inner cavity of the fixative solution container 1 so that the fixation device 20 can be completely inserted into the fixative solution container 1 and vertically placed side by side in the fixative solution container 1.
Two fixing clamping grooves 22 are formed in the side edge of the peripheral frame 21, and the peripheral frame 21 is fixed on the hanging rod 3 by hanging the two fixing clamping grooves 22 on the hook 4. The fixing slots 22 may be disposed on one or more sides of the peripheral frame 21, and the number of the fixing slots 22 is not limited to two, and may be set to be greater than two according to actual requirements. The number of the hooks 4 on each hanging rod 3 is equal to the number of the fixed clamping grooves 22 hung on the hooks 4 on the side edge of the peripheral frame 21.
The peripheral frame 21 defines an inner space where the tissue 26 is fixedly treated, and each side of the peripheral frame 21 includes a plurality of coupling through-holes 27 so that the coupling members of the tissue 26 are fixed to the peripheral frame, and specifically, the coupling members of the tissue 26 pass through the coupling through-holes 27 and are fixed to the peripheral frame 21. The connecting member of the tissue 26 includes a tissue fixing jig 23 and a jig fixer, wherein the tissue fixing jig 23 includes a clip or a hook, and the jig fixer includes a connecting band 24 and a fixing buckle 25, and the fixing buckle 25 is fitted over the connecting band 24 so that the connecting band can be fixed to the peripheral frame 21 by abutting against the peripheral frame 21. The connection band 24 passes through the connection through-hole 27 of the peripheral frame 21 and engages with the tissue fixing clip 23 to connect the corresponding tissue fixing clip 23 to the peripheral frame 21. The tissue fixing clip 23 is fixed to one end of the connection band 24 in the peripheral frame 21, thereby fixing the tissue 26.
In the using process, firstly, the tissue fixing clamp 23 is connected with the tissue 26, then the length of the connecting belt 24 in the inner space of the peripheral frame 21 is adjusted until the tissue 26 to be fixed is completely unfolded, the fixing buckle 25 is fastened to abut against the peripheral frame 21, after the examination, the fixing device with the tissue 26 is connected to the hook 4 on the hanging rod 3 through the fixing clamping groove 22, the fixing device is vertically suspended in the fixative solution container 1 and is completely immersed in the fixative solution, and the container cover body 5 is covered to start the fixing treatment.
Alternatively, the attachment through-holes 27 may be threaded holes, and the jig holder includes a screw and a nut (not shown in the drawings), by which the screw may be fixed to the peripheral frame 21. Wherein the screw is rotatably fixed to the tissue fixation clamp 23 such that the tissue 26 is not twisted during rotation of the screw to adjust the length of the screw within the interior space of the peripheral frame 21.
The tissue 26 is animal pericardial tissue such as bovine pericardium, porcine pericardium, and equine pericardium, and preferably bovine pericardium.
Tissue fixative solution glutaraldehyde solution is a very important solution throughout the tissue treatment process as it is the first step in histochemical fixation or crosslinking by glutaraldehyde solution. Because glutaraldehyde crosslinking of the tissue is a concentration and time dependent process, the fixative solution container 1 may also be provided with a circulation system including a tube 9 connected outside the fixative solution container 1 and a peristaltic pump 8 connected to the tube 9, the fixative solution being circulated through the tube 9 by the peristaltic pump 8 to maintain fluidity of the fixative solution during the fixation process, maintain the concentration balance of the fixative, and maintain the concentration of the fixative solution at a target level, thereby positively affecting the effect of the tissue fixation process. In addition, the circulating system is arranged, so that impurities can be prevented from being attached to and remained on tissues or being deposited at the bottom of the fixative solution container 1 in the fixing treatment process, and cleaning and maintenance are facilitated.
Wherein the tubing 9 is made of medical plastic.
In addition, the lower part of the side wall of the fixative solution container 1 is also provided with a water tap 10 communicated with the inside, and the fixative solution can be discharged through the water tap 10 after the fixation treatment operation is finished, so that the situation that glutaraldehyde is spilled due to pouring of the fixative solution is completely avoided, the dangerous occurrence frequency and the serious degree are reduced, and the device has the advantages of simple structure, rapidness, convenience, safety and environmental protection.
The method of operation of the tissue fixation treatment device of the present invention is described in detail below.
Opening the container cover 5 of the fixative solution container 1, taking out the peripheral frame 21, preparing for cleaning the tested animal pericardial tissue, adjusting the length of each connecting band 24 to be suitable for the area of the tissue 26, opening the clamp 23 to clamp the tissue 26, slightly adjusting the length of the connecting band 24 until the tissue 26 is unfolded and has no folds, and fastening the fixing buckle 25 to ensure that the tissue 26 is completely unfolded and mounted on the peripheral frame 21 and locked in a proper position. After the examination, the peripheral frame 21 is installed on the hook 4, and is vertically suspended in the fixative solution container 1 through the hanging rod 3, and the fixing of the pericardial tissues of the next batch of animals can be carried out by repeating the steps.
The fixing agent solution container 1 is filled with glutaraldehyde solution, the concentration of the glutaraldehyde is ranged from 0.20% to 0.625%, and the preserved/fixed animal pericardium tissue is used as valve material of the artificial heart valve. Preferably, a 0.5% glutaraldehyde solution is used to immobilize animal pericardial tissue as the valve material of a prosthetic heart valve. The glutaraldehyde solution has a pH of 7.3 to 7.5, preferably 7.4.
After it is determined that all the tissues to be fixed are placed in the tissue fixing treatment device 100, the container cover 5 of the fixative solution container 1 is closed, and important information such as the name and concentration of the fixative solution and the source of the tissues is noted on the blank label 7 on the box.
Maintaining the tissue in glutaraldehyde solution at room temperature for a period of 2 days to 2 weeks; preferably, the tissue is maintained in the glutaraldehyde solution for a period of 2 days at a temperature of 20 ℃.
The external peristaltic pump 8 is turned on to ensure circulation of the fixative solution at a flow rate of 0.1-2L/min, preferably 1.6L/min. At the same time, the operator records the fixation time until the tissue is completely cross-linked and fixed, and removes the tissue from the peripheral frame 21 for further study. After the fixation is completed, the tap 10 is opened, and the used fixative solution is collected in a waste liquid tank for treatment.
The above description of exemplary embodiments has been presented only to illustrate the technical solution of the invention and is not intended to be exhaustive or to limit the invention to the precise form described. Obviously, many modifications and variations are possible in light of the above teaching to those skilled in the art. The exemplary embodiments were chosen and described in order to explain certain principles of the invention and its practical application to thereby enable others skilled in the art to understand, implement and utilize the invention in various exemplary embodiments and with various alternatives and modifications.
Claims (25)
1. The utility model provides a processing apparatus is fixed to tissue, includes fixative solution container, container lid, a plurality of peg and a plurality of fixing device, its characterized in that:
the fixer solution container has an opening at the upper part, two ends of the plurality of hanging rods are fixed on two opposite side edges of the opening,
the fixation device includes a peripheral frame and tissue connecting members that are vertically suspended in a fixative solution container by hanger rods and that secure the tissue to the peripheral frame.
2. The tissue fixation treatment device according to claim 1, wherein a plurality of through holes are provided on each of two opposite sides of the opening of the fixative solution container, the through holes on the two opposite sides are opposite to each other in pairs and coaxial, and both ends of each hanging rod are inserted into and fixed in the two opposite through holes, respectively.
3. The tissue fixation treatment device of claim 1 or 2, wherein each hanger bar is provided with a plurality of hooks.
4. The tissue fixation treatment device of claim 1, wherein the peripheral frame is sized to fit within the interior cavity of the fixative solution container to allow the fixation device to be fully advanced into the fixative solution container.
5. The tissue fixation treatment device of claim 1, wherein the internal space defined by the peripheral frame is a tissue fixation treatment space.
6. The tissue fixation device of claim 3, wherein the peripheral frame defines a fixation slot for hanging the peripheral frame from the hook.
7. The tissue fixation device of claim 5, wherein the peripheral frame defines a plurality of attachment openings therethrough for securing the tissue attachment member to the peripheral frame.
8. The tissue fixation treatment device of claim 7, wherein the tissue attachment member comprises a tissue fixation clamp and a clamp holder.
9. The tissue fixation device of claim 8, wherein the tissue fixation clamp comprises a clip or hook.
10. The tissue fixation device of claim 9, wherein the clip holder comprises a connector strap and a fastener, or a screw and nut.
11. The tissue fixation device of claim 10, wherein the clip holder is coupled to the tissue fixation clip by a coupling aperture in the peripheral frame, the coupling band or screw being adjustable in length within the peripheral frame by a respective length of the coupling band or screw.
12. The tissue fixation treatment device of claim 1 or 2, wherein a blank label is provided on the outer wall of the fixative solution container.
13. The tissue fixation device of claim 1, wherein a handle is provided on the container cover.
14. The tissue fixation treatment device of claim 3, wherein the hooks are S-shaped or omega-shaped.
15. The tissue fixation treatment device of claim 1, wherein the fixative solution container is further provided with a circulation system comprising a tube connected outside the fixative solution container and a peristaltic pump connected to the tube, the fixative solution being circulated through the tube by the peristaltic pump to maintain the fixative solution in a fluid state during the fixation treatment and to maintain a concentration balance of the fixative.
16. The tissue fixation treatment device according to claim 1, wherein a water tap communicating with the inside is provided at a lower portion of a sidewall of the fixative solution container, and the fixative solution can be discharged through the water tap after the fixation treatment operation is completed.
17. The tissue fixation treatment device of claim 1, wherein the peripheral frame, the hanger bar are made of a medical plastic or a medical stainless steel material.
18. The tissue fixation treatment device of claim 1, wherein the tissue comprises animal pericardial tissue and is used to prepare a prosthetic valve for valve replacement surgery.
19. The tissue fixation treatment device of claim 1, wherein the fixative solution comprises glutaraldehyde and isopropyl alcohol.
20. The tissue fixation treatment device of claim 1, wherein the internal dimensions of the fixative solution container are 45cm long, 30cm wide, and 30cm high, and the wall thickness of the fixative solution container is 4-8 mm.
21. A method of operating the tissue fixation treatment device of any one of claims 1-20, comprising the steps of,
securing the tissue to the peripheral frame by tissue attachment members;
sequentially installing the peripheral frame with the tissue on a hanging rod in a fixing agent solution container, wherein a glutaraldehyde solution is filled in the fixing agent solution container, the concentration range of the glutaraldehyde solution is from 0.20% to 0.625%, and the pH value of the glutaraldehyde solution is 7.3-7.5;
maintaining the tissue in glutaraldehyde solution at room temperature for a period of 2 days to 2 weeks;
until the tissue is completely cross-linked to complete the fixation, the peripheral frame is removed from the fixative solution container, and the tissue is then removed from the peripheral frame.
22. The method of claim 21, wherein during the tissue fixation, an external peristaltic pump is turned on to ensure circulation of the fixative solution at a flow rate of 0.1-2L/min.
23. The method of claim 21, wherein after the fixing is completed, a tap is opened and the used fixative solution is collected in a waste tank for disposal.
24. The method of claim 21, wherein the glutaraldehyde solution has a concentration of 0.5% and the glutaraldehyde solution has a PH of 7.4, and the tissue is maintained in the glutaraldehyde solution for 2 days at a temperature of 20 ℃.
25. The method of claim 22, wherein the flow rate of the fixative solution is 1.6L/min.
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