CN219354281U - Valve preprocessing device and valve preprocessing module - Google Patents

Abstract

The utility model provides a valve pretreatment device and a valve pretreatment module. The valve pretreatment module comprises a mould core and a valve pretreatment device, wherein the valve pretreatment device is used for presetting valve materials, the mould core is used for folding the preset valve materials, the valve pretreatment device comprises a sizing mould and a gravity block, the sizing mould comprises a male mould and a female mould which are matched with each other, the valve materials are placed between the male mould and the female mould, the gravity block is used for connecting the valve materials on the sizing mould so as to apply tension in the circumferential direction to the valve materials and tension the valve materials, and the valve materials on the sizing mould can be preset under preset conditions so as to strengthen the mechanical property of the artificial valve in the circumferential direction, reduce the valve She Xizhou and improve the valve durability.

Description

Valve preprocessing device and valve preprocessing module

Technical Field

The utility model relates to the field of production and processing of artificial valves, in particular to a valve pretreatment device and a valve pretreatment module.

Background

The heart contains four heart chambers, the left atrium and left ventricle being located on the left side of the heart and the right atrium and right ventricle being located on the right side of the heart. The atrium forms a ventricular outflow tract with the ventricle, the left ventricle forms a left ventricular outflow tract with the aorta, and the right ventricle forms a right ventricular outflow tract with the pulmonary artery. Valves with a one-way valve function are arranged at the positions of the ventricular inflow channel and the left ventricular outflow channel, so that the normal flow of blood in the heart chamber is ensured. When this valve becomes problematic, cardiac hemodynamics changes and cardiac dysfunction, known as valvular heart disease.

With the development of socioeconomic performance and the aging of population, the incidence of valvular heart disease is obviously increased, and research shows that the incidence of valvular heart disease of the aged population over 75 years is as high as 13.3%. At present, the traditional surgical treatment is still the first treatment means for patients with severe valvular disease, but for the aged, combined multi-organ diseases, patients with history of open chest surgery and poor cardiac function, the traditional surgical treatment has high risk and mortality rate, and some patients do not have the opportunity of operation. The transcatheter valve replacement/repair has the advantages of no need for chest opening, less trauma, quick patient recovery, and the like, and has received great attention.

The manufacture of valves is an extremely complex process, for example biological valves, including pericardial harvesting, defect removal, solution fixation, decellularization, load reduction, anti-calcification, suturing, sterilization, etc. However, most of the prepared valves have insufficient durability, the service life of the valves is reduced, the production process is complex, and the production efficiency is low.

It should be noted that the information disclosed in the background section of the present application is only for enhancement of understanding of the general background of the present application and should not be taken as an admission or any form of suggestion that this information forms the prior art already known to a person skilled in the art.

Disclosure of Invention

The utility model provides a valve pretreatment device and a valve pretreatment module, which are used for solving the problems of insufficient durability, complex production procedures and low production efficiency of a prosthetic valve in the prior art.

To achieve the above object, the present utility model provides a valve pretreatment device for pre-shaping treatment of valve material, comprising a shaping mold and a gravity block, wherein the shaping mold comprises a male mold and a female mold which are matched, the male mold and the female mold are used for placing the valve material therebetween, and the gravity block is used for connecting the valve material on the shaping mold so as to apply a tensile force in a circumferential direction to the valve material and tension the valve material.

In one embodiment, the valve pretreatment device further comprises a treatment chamber, wherein the sizing die and the gravity block are both for placement in the treatment chamber, and wherein the valve material on the sizing die is for being pre-shaped for treatment in the treatment chamber with predetermined conditions.

In one embodiment, the processing chamber is a stationary container for holding a cross-linking agent that constitutes the predetermined condition.

In one embodiment, the cross-linking agent is glutaraldehyde or genipin.

In one embodiment, the valve pretreatment device further comprises a support seat disposed within the fixed container, and the sizing die is configured to be placed on the support seat.

In one embodiment, the processing chamber is a temperature and humidity box configured to have a temperature, humidity and processing time that constitute the predetermined condition.

In one embodiment, the temperature is 60 ℃ to 120 ℃, the humidity is 10% -80%, and the treatment time is 1-6 hours.

In one embodiment, the female die has a plurality of concave surfaces arranged in a linear manner, the male die has a plurality of convex surfaces arranged in a linear manner, the convex surfaces are matched with the concave surfaces in a one-to-one correspondence manner, valve materials are arranged between the convex surfaces and the concave surfaces, and in the process of presetting, the concave surfaces are arranged in the horizontal direction, and the concave surfaces are arranged upwards or downwards.

In one embodiment, the female die has a groove for mounting the male die, the groove and the female face are disposed on the same side, and/or the weight of the gravity block is 1g-20g.

To achieve the above object, the present utility model further provides a valve pretreatment module, which includes a mold core and any one of the valve pretreatment devices, wherein the valve pretreatment device is used for pre-shaping of valve materials, and the mold core is used for folding treatment of pre-shaped valve materials.

The valve pretreatment device provided by the utility model is used for pre-shaping treatment of valve materials and comprises a shaping mould and a gravity block, wherein the shaping mould comprises a male mould and a female mould which are matched, the valve materials are placed between the male mould and the female mould, the gravity block is used for connecting the valve materials on the shaping mould so as to apply a tensile force in the circumferential direction to the valve materials and tension the valve materials, and the valve materials on the shaping mould are used for being pre-shaped under a preset condition. So configured, during the manufacturing process, the mechanical properties of the prosthetic valve in the circumferential direction can be enhanced, the valve She Xizhou can be reduced, and the durability of the valve can be improved through a pre-shaping procedure.

Because the valve pretreatment module provided by the application and the valve pretreatment device provided by the application belong to the same utility model conception, the valve pretreatment module provided by the application has all the advantages of the valve pretreatment device provided by the application, and the beneficial effects of the valve pretreatment module provided by the application are not repeated one by one.

Drawings

Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present utility model and do not constitute any limitation on the scope of the present utility model. Wherein:

FIG. 1 is a simplified schematic structural diagram of a valve pretreatment device of an embodiment of the present utility model;

FIG. 2 is a top view of a valve pretreatment device of an embodiment of the present utility model;

FIG. 3 is a schematic view of the configuration of a sizing die of an embodiment of the present utility model loaded with valve material by a male die and a female die;

FIG. 4 is a schematic structural view of a female die according to an embodiment of the present utility model;

FIG. 5 is a force diagram of a prosthetic valve of an embodiment of the utility model;

FIG. 6 is a schematic view of a mold core according to an embodiment of the present utility model at a first view angle;

FIG. 7 is a schematic view of a mold core according to an embodiment of the present utility model at a second view angle;

FIG. 8 is a flow chart of the preparation of a prosthetic valve prosthesis according to a preferred embodiment of the present utility model;

fig. 9 is a flow chart of the preparation of a prosthetic valve prosthesis according to another preferred embodiment of the present utility model.

In the accompanying drawings:

10-valve material; 20-a prosthetic valve; 100-valve pretreatment device; 110-a processing chamber; 120-supporting seats; 130-shaping a mold; 1310-a female die; 1311-concave; 1312-trenches; 1320—a punch; 1321-convex; 140-gravity block; 200-mould cores; f1-flap She Zhouxiang stress; f2-radial stress of the valve leaflet; l-length direction.

Detailed Description

The following description of the embodiments of the present utility model will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the utility model are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to be within the scope of the utility model.

In the description of the present utility model, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present utility model and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present utility model.

In the description of the present utility model, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present utility model will be understood in specific cases by those of ordinary skill in the art.

The core of the utility model is to provide a valve pretreatment device and a valve pretreatment module, so as to solve the problems of insufficient durability, complex production and preparation process, high production cost, low production efficiency and the like of the artificial valve prepared by the prior art.

The following description refers to the accompanying drawings. The following embodiments and features of the embodiments may be complemented or combined with each other without conflict.

As shown in fig. 1-4, the present utility model provides a valve pretreatment device 100 for pre-shaping of valve material 10 to improve the mechanical properties of a prosthetic valve. The valve material 10 herein is used to make a prosthetic valve, which may be of various uses including, but not limited to, a prosthetic heart valve. The valve pretreatment device 100 of the present application is also applicable to the pre-molding of an integrated valve, where the integrated design refers to the valve and skirt being integrally or unitarily molded. The integrated valve can furthest reduce damage to valve materials, increase durability of the valve, simplify sewing procedures, reduce production cost and improve production efficiency.

The valve material 10 may be selected from biological tissue, such as chemically stable tissue from a heart valve of an animal (e.g., pig), or from pericardial tissue of an animal, such as bovine (bovine pericardium) or ovine (ovine pericardium) or porcine (porcine pericardium) or equine (equine pericardium), preferably bovine pericardial tissue. In addition, synthetic materials may also be used to prepare valve material 10. The synthetic material is for example selected from expanded polytetrafluoroethylene or polyester. Optionally, the synthetic material may further be at least one material selected from the group consisting of thermoplastic polycarbonate polyurethane, polyether polyurethane, segmented polyether polyurethane, silicone-polycarbonate polyurethane, and ultra-high molecular weight polyethylene. The synthetic material may also be selected from other biocompatible polymers, optionally including polyolefins, elastomers, polyethylene glycol, polyethersulfone, polysulfone, polyvinylpyrrolidone, polyvinylchloride, other fluoropolymers, silicone polyesters, silicone polymers and/or oligomers, and/or polylactones, and block copolymers using them, particularly combinations of one or more of these materials.

After the valve material 10 is obtained, the valve material 10 is preformed by the valve pretreatment device 100, so that the mechanical property of the artificial valve in the circumferential direction is enhanced, valve folds are reduced, and the durability of the valve is improved.

The valve pretreatment device 100 comprises at least a sizing die 130 and a gravity block 140, optionally the valve pretreatment device 100 further comprises a treatment chamber 110. Wherein the sizing die 130 comprises a female die 1310 and a male die 1320 which are matched, and valve material 10 can be placed between the male die 1320 and the female die 1310. Specifically, the female die 1310 has a plurality of concave surfaces 1311 arranged in a linear fashion, the male die 1320 also has a plurality of convex surfaces 1321 arranged in a linear fashion, the convex surfaces 1321 and the concave surfaces 1311 mate in a one-to-one correspondence, the shapes of the convex surfaces 1321 and the concave surfaces 1311 match, the shapes of the convex surfaces 1321 and the concave surfaces 1311 are each determined by the shape of the desired prosthetic valve, and the valve material 10 is placed between the convex surfaces 1321 and the concave surfaces 1311. The gravity block 140 is used to connect the valve material 10 on the sizing die 130 to apply a tension in the circumferential direction to the valve material 10 and to tension the valve material 10. Here, the pulling force applied by the gravity block 140 is along the gravity direction, but the pulling force applied by the gravity block 140 is mapped to the circumferential stress of the prosthetic valve when the prosthetic valve is in a three-dimensional form.

In the pre-shaping, the valve material 10 on the shaping die 130 needs to be pre-shaped under predetermined conditions. The predetermined conditions herein are set in accordance with the valve material 10. If biological tissue is selected for the valve material 10, the predetermined conditions are set using a cross-linking agent. If the valve material 10 is a polymeric material, the predetermined conditions are heat set. Typically, both the sizing die 130 and the gravity block 140 are placed in the processing chamber 110 such that the valve material 10 on the sizing die 130 is pre-molded in the processing chamber 110 with predetermined conditions. The processing chamber 110 may be an external structure or a self-structure of the valve pretreatment device 100. In this embodiment, the valve pretreatment device 100 further includes a treatment chamber 110.

In one embodiment, as shown in fig. 1 and 2, the processing chamber 110 is a stationary container for holding a cross-linking agent that constitutes a predetermined, pre-set condition. The type of the crosslinking agent is not particularly limited, and is generally glutaraldehyde, genipin, or the like. The cross-linking agent facilitates the shaping of the biological tissue-prepared valve material 10 without disrupting the structure of the valve material 10. Further, the valve pretreatment device 100 further comprises a support base 120, the support base 120 is disposed in the fixed container, the shaping mold 130 can be placed on the support base 120, and the gravity block 140 can be freely suspended at two ends of the valve material 10. The valve material 10 described herein is in a two-dimensional deployed configuration, which may be two-valved or three-valved, in this embodiment the valve material 10 is three-valved. The weight of the weight block 140 is set as desired and is used to tension the valve material 10. The weight 140 may be selected as a weight having a gram number of 1g to 20g, preferably 5g to 15g.

In one embodiment, during the pre-molding process, the valve material 10 is placed in the sizing mold 130, and a gravity block 140 is used to apply a circumferential pulling force to the valve material 10 on the sizing mold 130 and to tension the valve material 10, and the sizing mold 130 is placed in the process chamber 110 containing the cross-linking agent, preferably the sizing mold 130 is placed on the support base 120. In this embodiment, when a tension force is applied to the valve material 10 in the circumferential direction by using the gravity blocks 140, gravity blocks 140 having a proper weight are respectively connected to both ends of the valve material 10 in the longitudinal direction L. The cross-linking agent is preferably glutaraldehyde, and the mass percentage concentration of the glutaraldehyde solution is 0.1% -1%, preferably 0.3% -0.7%. The treatment time for setting the crosslinking agent is generally not less than 7 days.

In another embodiment, the process chamber 110 is a temperature and humidity tank configured to have a temperature, humidity, and process time that constitute predetermined conditions for heat setting. Further, the temperature is 60-120 ℃, preferably 80-100 ℃, the humidity is 10-80%, preferably 30-60%, and the treatment time is 1-6 hours, preferably 2-4 hours.

The shaping mold 130 may be made of metal material, such as 316 stainless steel, 304 stainless steel, or polymer material, such as PTFE, PET, PE.

As shown in fig. 4, the female die 1310 of the shaping mold 130 may have a groove 1312, the groove 1312 and the concave surface 1311 being disposed on the same side. Referring also to fig. 3, a punch 1320 may be inserted into the groove 1312 for a locating installation. Referring to fig. 1, in the pre-shaping, the length direction L of the valve material 10 is in the horizontal direction, i.e., the plurality of concave surfaces 1311 are arranged in the horizontal direction, and the concave surfaces 1311 are disposed upward or downward, in this embodiment, the concave surfaces 1311 are upward.

The valve material 10 retains a margin prior to the pre-molding process, where the margin facilitates attachment of the gravity blocks 140 at both ends of the valve material 10 such that the gravity blocks 140 can be secured to the valve material 10 and exert a tensile force on the valve material 10.

As will be appreciated with reference to fig. 5, a three-valve prosthetic valve 20 is illustrated as an example. During normal use, the circumferential force F1 of the prosthetic valve 20 is greater than the radial force F2, and then, during pre-shaping, the weight 140 applies a tensile force to the valve material 10 in the circumferential direction, enhancing the mechanical properties of the prosthetic valve 20 in the circumferential direction, reducing the valve She Xizhou, and improving the valve durability.

The valve pretreatment device 100 may perform a pretreatment of the valve material 10 that has been cut. In one embodiment, the cut valve material 10 is obtained, and then the cut valve material 10 is subjected to a pre-shaping process, and then the pre-shaped valve material 10 is folded into a three-dimensional shape.

Further, the utility model also provides a valve pretreatment module, which comprises the valve pretreatment device 100. As shown in fig. 6 and 7, the valve pretreatment module further includes a mold core 200 for performing a folding process on the pre-shaped valve material 10, so that the valve material 10, which is originally two-dimensionally unfolded, is folded into a three-dimensional form. Compared with manual folding, the folding effect of the mold core 200 is better, and the folding is more convenient and quick. The mold core 200 may be made of metal material, such as 316 stainless steel, 304 stainless steel, etc., or polymer material, such as PTFE, PET, PE, etc. The configuration of the mold core 200 depends on the three-dimensional morphology of the prosthetic valve 20. The pre-shaped valve material 10 is folded along the mold core 200 and excess valve material is trimmed away.

The present application is further described below in connection with the preparation of a prosthetic valve prosthesis.

In an exemplary embodiment, as shown in fig. 8, a complete prosthetic valve prosthesis may be prepared using steps S (1) through S (5) as follows.

Step S (1): and obtaining pericardial tissue. Pericardial tissue is used as valve material 10.

After obtaining the pericardial tissue, the pericardial tissue is quickly washed in a sterile physiological saline (e.g., a sterile physiological saline at about 4 ℃), and the washed pericardial tissue is preserved in a physiological saline containing an antibiotic (e.g., a physiological saline containing 1% of the antibiotic), and the pericardial tissue is fat-stripped, trimmed and washed.

Step S (2): cutting. Pericardial tissue is trimmed according to the specified leaflet shape, typically by laser cutting or blade cutting, with laser cutting being preferred.

Step S (3): and (5) presetting. At this time, the valve pretreatment device 100 performs the pretreatment of the cut pericardial tissue, and the mechanical properties in the direction of the valve She Zhouxiang are enhanced by the pretreatment, so that the valve She Xizhou is reduced and the valve durability is improved. Specifically, the shaping mold 130 with the pericardial tissue is placed in a fixed container together with the gravity block 140, and the pre-shaping is completed by the crosslinking agent.

Step S (4): folding. The pre-shaped pericardial tissue is folded by the mold core 200.

Step S (5): and (5) stitching. And suturing and fixing the folded pericardial tissue and the valve stent to finally obtain the complete prosthetic valve prosthesis.

Since the present application does not relate to improvements to valve stents, the structure of the valve stent is not described in detail.

In another exemplary embodiment, as shown in fig. 9, another prosthetic heart valve prosthesis is prepared using the following steps S (1 ') to S (5'), in which the pericardial tissue of the above embodiment is replaced with a polymer material.

Specifically, step S (1'): and obtaining a high polymer material. The polymer material can be selected from PU, PTFE, PET, SIBS, etc., and can be obtained by synthesis, braiding, heat setting, etc. The polymer material is also used as the valve material 10.

Step S (2'): cutting. And cutting the high polymer material according to the specified valve leaf shape, and likewise, cutting can be realized by laser cutting or blade cutting, and laser cutting is preferred.

Step S (3'): and (5) presetting. The valve pretreatment device 100 is used for presetting the cut polymer material, and the mechanical property of the valve She Zhouxiang is enhanced by the presetting, so that the valve She Xizhou is reduced, and the durability of the valve is improved. Specifically, the shaping mold 130 filled with the polymer material and the gravity block 140 are put together into a temperature and humidity box, and the heat pre-shaping is completed in the temperature and humidity box with a certain temperature, humidity and processing time.

Step S (4'): folding. The pre-molded polymer material is also folded by the mold core 200, and the excess polymer material is trimmed.

Step S (5'): and (5) stitching. And suturing and fixing the folded high polymer material and the valve stent to finally obtain the complete artificial valve prosthesis.

Preferably, valve material 10 is a unitary valve material from which the unitary valve is made. The integrated valve is used on a prosthetic heart valve prosthesis and is sutured and fixed with a valve stent by sutures. The integrated valve may include a prosthetic leaflet and skirt connected in sequence, the skirt may be a single inner skirt or a double inner and outer skirt. The inner skirt is directly connected with the artificial valve leaflet, and the outer skirt is folded along one side of the inner skirt to the outside of the valve support.

In summary, the valve pretreatment device provided by the application can perform presetting on valve materials, enhance the mechanical property of the artificial valve in the circumferential direction, reduce the valve She Xizhou, improve the durability of the valve, simplify the production process and improve the production efficiency.

It should be noted that, in the present description, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different manner from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other. For the system disclosed in the embodiment, the description is relatively simple because of corresponding to the method disclosed in the embodiment, and the relevant points refer to the description of the method section.

It should be further noted that although the present utility model has been disclosed in the preferred embodiments, the above embodiments are not intended to limit the present utility model. Many possible variations and modifications of the disclosed technology can be made by anyone skilled in the art without departing from the scope of the technology, or the technology can be modified to be equivalent. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present utility model still fall within the scope of the technical solution of the present utility model.

It should be further understood that the terms "first," "second," and the like in this specification are used solely to distinguish one from another component, element, step, or the like in the specification and do not necessarily denote a logical or sequential relationship between the individual components, elements, steps, or the like, unless otherwise indicated.

It should also be understood that the terminology described herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present utility model. It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. For example, reference to "a step" or "an apparatus" means a reference to one or more steps or apparatuses, and may include sub-steps as well as sub-apparatuses. All conjunctions used should be understood in the broadest sense. And, the word "or" should be understood as having the definition of a logical "or" rather than a logical "exclusive or" unless the context clearly indicates the contrary. Furthermore, implementation of the methods and/or apparatus in embodiments of the utility model may include performing selected tasks manually, automatically, or in combination.

Claims (9)

1. A valve pretreatment device for pre-shaping valve materials, comprising a shaping mould and a gravity block, wherein the shaping mould comprises a male mould and a female mould which are matched, the male mould and the female mould are used for placing the valve materials, the gravity block is used for connecting the valve materials on the shaping mould so as to apply tension in the circumferential direction to the valve materials and tension the valve materials, and the valve materials on the shaping mould can be pre-shaped under the preset condition.

2. The valve pretreatment device of claim 1, further comprising a treatment chamber, wherein the sizing mold and the gravity block are each for placement in the treatment chamber, wherein the valve material on the sizing mold is for being pre-shaped in the treatment chamber with a predetermined condition.

3. The valve pretreatment device of claim 2, wherein the treatment chamber is a stationary container for holding a cross-linking agent, the cross-linking agent comprising the predetermined condition.

4. The valve pretreatment device of claim 3, wherein the cross-linking agent is glutaraldehyde or genipin.

5. The valve pretreatment device of claim 3, further comprising a support seat disposed within the stationary container, the sizing die being configured to rest on the support seat.

6. The valve pretreatment device of claim 2, wherein the treatment chamber is a temperature and humidity tank.

7. The valve pretreatment device according to claim 1, wherein the female die has a plurality of concave surfaces arranged in a straight line, the male die has a plurality of convex surfaces arranged in a straight line, the convex surfaces are mated with the concave surfaces in one-to-one correspondence, the valve material is disposed between the convex surfaces and the concave surfaces, the plurality of concave surfaces are disposed in a horizontal direction in the pre-shaping, and the concave surfaces are disposed upward or downward.

8. Valve pretreatment device according to claim 7, characterized in that the female die has a groove for mounting the male die, the groove and the concave surface being arranged on the same side, and/or that the weight of the gravity block is 1g-20g.

9. Valve pretreatment module comprising a mould core for a pre-shaping of valve material and a valve pretreatment device according to any of claims 1-8 for a folding treatment of the pre-shaped valve material.