阅读说明：本技术 阴道松弛矫治假体及其用法 (Vaginal relaxation correction prosthesis and use method thereof ) 是由 王忠堂 于 2021-08-21 设计创作，主要内容包括：一种阴道松弛矫治假体,其包括多个植入小体,多个植入小体连接成为鹅卵石样排列的网格结构,或串珠样阵列结构,植入小体还可包括裙边,植入小体可以为实心体,也可以包括内囊,内囊可由医用液态凝胶或生理盐水充填,植入小体采用柔软材料制作,通过外科手术在阴道后壁和侧壁粘膜下植入假体,达到长期稳定的缩小阴道容积、减轻阴道后壁脱垂效果。(The utility model provides a vagina laxity corrects prosthesis, it includes a plurality of implant corpuscles, a plurality of implant corpuscles are connected and become the grid structure of cobblestone appearance arrangement, or string bead appearance array structure, implant the corpuscle and can also include the shirt rim, implant the corpuscle and can be the solid, also can include the inner bag, the inner bag can be filled by medical liquid gel or normal saline, implant the corpuscle and adopt soft material to make, implant the prosthesis through surgery under vagina back wall and lateral wall mucosa, reach long-term stable reduction vagina volume, alleviate vagina back wall prolapse effect.)

1. The utility model provides a vagina laxity is rescued and is rescued false body for implanting vagina back wall and lateral wall submucosal lacuna, reduces vagina volume, alleviates vagina back wall prolapse which characterized in that: the prosthesis comprises:

a filling member for placement into the posterior vaginal wall and the lateral submucosal cavity, the filling member including a plurality of implanted bodies;

and the cross-linking component is used for connecting two or three adjacent small implant bodies so that the small implant bodies are arranged into a cobblestone pavement-like grid structure, and the cross-linking component comprises a plurality of ropes.

2. The prosthesis of claim 1, wherein:

the filling part comprises a high convex implanted corpuscle, a medium convex implanted corpuscle and a low convex implanted corpuscle;

the small implant body comprises a central area and a peripheral area, wherein the central area is raised, and the peripheral area is low and flat;

the strip cable is in a cylindrical, linear or belt-shaped structure.

3. The prosthesis according to claims 1 and 2, wherein:

the filling part comprises a core area and a peripheral area, the core area comprises the high-convexity implanted corpuscle and the medium-convexity implanted corpuscle, and the peripheral area comprises the low-convexity implanted corpuscle.

4. The prosthesis of claim 1, wherein:

the implanted corpuscle further comprises a skirt for alleviating capsular contracture, the skirt surrounding the implanted corpuscle.

5. The prosthesis of claim 1, wherein:

the prosthesis further comprises a "bead-like" arrangement consisting of the cord connecting a plurality of the implant bodies;

the prosthesis further comprises a 'fence' -like arrangement consisting of the cord connecting a plurality of the implanted corpuscles.

6. The prosthesis of claim 1, wherein:

the small implant body further comprises a shell, an inner bag and a core material, wherein the shell wraps the inner bag, and the core material is arranged inside the inner bag.

7. The prosthesis of claims 1 and 5, wherein:

the prosthesis further comprises a mesh bag surrounding the "cobblestone pavement" like grid structure or the "bead string" like arrangement structure or the "fence" like arrangement structure.

8. The utility model provides a vagina laxity is rescued and is rescued false body application, selects the accurate implantation preset position of the false body of suitable vagina laxity, its characterized in that: the use method comprises the following steps:

step 1: evaluating the vaginal relaxation type and the relaxation degree of a patient, and selecting a proper vaginal relaxation correction prosthesis;

step 2: surgery creates a cavity between the vaginal mucosa and the muscle layer;

and step 3: the vaginal relaxation correcting prosthesis is placed, the position of the vaginal relaxation correcting prosthesis is adjusted, and a certain number of implanted corpuscles and a certain number of bar ropes are cut off or the implanted corpuscles are carved to modify the shape and the thickness of the implanted corpuscles when necessary;

and 4, step 4: fixing the vaginal relaxation correction prosthesis;

and 5: the incision is sutured and bandaged.

9. The use according to claim 8, wherein: in step 1, the method further comprises:

when the patient is pure vaginal soft tissue laxity, the vaginal laxity correction prosthesis suitable for the vaginal back wall is selected to be implanted;

when the patient relaxes the vaginal soft tissue and widens the pubis combined gap, implanting vaginal relaxation correction prostheses suitable for the back wall and partial side walls of the vagina selectively;

when the patient has vaginal soft tissue relaxation and pubic symphysis gap is obviously widened, vaginal relaxation corrective prostheses suitable for the back wall and all side walls of the vagina are selectively implanted.

10. The use according to claim 8, wherein: in step 1, the method further comprises:

when the patient is slightly lax of the vagina soft tissue, the thin vagina laxity correcting prosthesis is selected to be implanted;

when the patient has moderate laxity of the vaginal soft tissue, the middle-thick vaginal laxity correction prosthesis is selected to be implanted;

when the patient is severely relaxed in the vaginal soft tissue, the thick vaginal relaxation correction prosthesis is selected to be implanted;

when the patient is very severely relaxed in the vagina soft tissue, implanting thickened vagina relaxation corrective prosthesis;

when the patient has vaginal soft tissue relaxation and vaginal back wall prolapse, the vaginal relaxation corrective prosthesis with the fence-like arrangement structure is implanted.

Technical Field

The application relates to the field of medical instruments, in particular to a vaginal relaxation correction prosthesis and a use method thereof.

Background

Vaginal relaxation is difficult to avoid due to childbirth, congenital development or aging. The vaginal relaxation causes the reduction of the sexual life quality and brings endless troubles to people, so the technical proposal for correcting the vaginal relaxation is produced at present.

Kegel exercise corrects vaginal laxity. Many people do not achieve good results because of the need to adhere to exercise for a long period of time.

The noninvasive photoelectric treatment achieves the effect of mild vagina contraction by damaging vagina mucosa and mucosa edema. When mucosal edema subsides, the effect disappears.

The minimally invasive filling is injected with the filling agent through the vaginal mucosa to achieve the effects of mild and moderate vagina contraction. When the filler is absorbed and degraded, the effect disappears. In addition, the perineum is rich in blood vessels, and the filler is easy to cause venous embolism and death of patients.

The elastic thread is embedded under the vaginal mucosa, on one hand, the effect is poor, and on the other hand, the elastic thread is embedded under blind vision, so that the urethra is easy to be damaged or ligated, and the urination is difficult.

The surgical operation achieves the vagina contracting effect by separating the wound surface, repositioning the vaginal mucosa muscle by using a suture, and healing the wound surface in a staggered way. But with the degradation or the tearing off of the suture, the wound surface with the malposition healing is reset again, and the effect is lost. In addition, surgical treatment of vaginal relaxation caused by pubic symphysis widening is not effective.

The vaginal implant (CN 102770095A) is mainly used for preventing pain caused by friction of vaginal scar during sexual intercourse, and also has vagina contracting effect. In actual use, it is easy to slip from the vagina.

In view of this, implantable prostheses are designed and manufactured to be suitable for various types of vaginal relaxation, and the lacuna is separated between the vaginal mucosa and the perineal muscle layer by a simple surgical operation, and the corresponding type of prosthesis is selected and implanted into the lacuna, thereby enabling patients with different degrees of vaginal relaxation and patients with vaginal relaxation combined with pubic symphysis widening and posterior vaginal wall prolapse to obtain a long-term stable vaginal tightening effect.

Disclosure of Invention

The technical problem to be solved.

The method comprises the steps of designing and manufacturing implantable prostheses suitable for various vaginal relaxation types, separating cavities between vaginal mucosa and perineal muscle layers through surgical operations, implanting prostheses of corresponding types, and correcting different types of vaginal relaxation, vaginal relaxation and pubic symphysis widening and vaginal posterior wall prolapse.

The second technical proposal.

In order to solve the above technical problems, an aspect of the present application provides a vaginal relaxation orthosis, the prosthesis including a filling member for filling the posterior vaginal wall and the submucosal space of the side wall, a cross-linking member for connecting two or three adjacent "cobblestone" -like implant bodies such that the implant bodies are arranged in a "cobblestone" like lattice, and a plurality of cords.

In an exemplary embodiment of the present application, the filling member includes a high convexity implanted corpuscle, a medium convexity implanted corpuscle, and a low convexity implanted corpuscle.

In an exemplary embodiment of the present application, the implant body includes a central region, a rim region, the central region being raised, the rim region being low flat.

In an exemplary embodiment of the present application, the cord is cylindrical, wire-like or ribbon-like.

In an exemplary embodiment of the present application, the filling member includes a core region and a peripheral region, the core region includes the high convexity implanted corpuscle and the medium convexity implanted corpuscle, and the peripheral region includes the low convexity implanted corpuscle.

In an exemplary embodiment of the present application, the prosthesis further comprises a skirt for reducing capsular contracture, the skirt surrounding the implant corpuscle.

In an exemplary embodiment of the present application, the prosthesis further comprises a "bead" like arrangement consisting of the cord connecting a plurality of the implant corpuscles.

In an exemplary embodiment of the present application, the prosthesis further comprises a "palisade" -like arrangement consisting of the cord connecting a plurality of the implant corpuscles.

In an exemplary embodiment of the present application, the implanted corpuscle is elliptical, with a major axis of 10 mm to 100 mm and a minor axis of 5 mm to 25 mm.

In an exemplary embodiment of the present application, the implanted corpuscle may also be circular, rectangular, irregular.

In an exemplary embodiment of the present application, the implanted corpuscle includes a shell, an inner bag, a core material, the shell wraps the inner bag, the inner bag is internally provided with the core material, the thickness of the shell is 0.1 mm to 1 mm, the shore hardness is 10 degrees to 45 degrees, the medical silica gel or other materials are adopted, and the core material is liquid medical gel, physiological saline or other materials.

In an exemplary embodiment of the present application, the prosthesis further comprises a mesh bag, wherein the mesh bag is wrapped around a "cobblestone pavement" like grid or a "bead string" like arrangement structure formed by the implanted corpuscles and the rope, and is made of absorbable degradable materials or non-degradable materials.

In an exemplary embodiment of the present application, the prosthesis further comprises a needle inlet hole, which is provided in the implant body, the cord, the mesh bag or the skirt for suture fixation.

In one aspect of the application, a process for manufacturing a vaginal relaxation corrective prosthesis is provided. The vagina laxity correction prosthesis manufacturing process comprises solid prosthesis manufacturing, hollow prosthesis manufacturing and mixed prosthesis manufacturing, and the solid prosthesis manufacturing of the embodiment of the application comprises silica gel solid prosthesis manufacturing, expanded solid prosthesis manufacturing and solid prosthesis knitting manufacturing.

In an exemplary embodiment of the present application, the process flow 100 for manufacturing a silicone solid prosthesis includes the following steps.

110: and 3D modeling of the silica gel solid prosthesis.

120: and developing a silica gel solid prosthesis mould.

130: the method for producing the silica gel solid prosthesis comprises compression molding, injection molding and 3D printing.

140: the quality of the silicone solid prosthesis was checked.

150: and (5) sterilizing the silica gel solid prosthesis.

160: and classifying and aseptically packaging the silica gel solid prosthesis.

In an exemplary embodiment of the present application, another process flow 200 for manufacturing a silicone solid prosthesis includes the following steps.

210: and 3D modeling, including implant corpuscle modeling and cord modeling.

220: implant corpuscle and cord molds were developed.

230: implant bodies and cords are produced.

240: assembling the silica gel solid prosthesis, which comprises preparing an implant corpuscle, a truncated rope and combining and bonding the silica gel solid prosthesis.

250: checking the quality of the silica gel solid prosthesis, sterilizing, classifying and packaging aseptically.

In an exemplary embodiment of the present application, the mesh bag manufacturing process 300 may include mold pressing, mold injection, 3D printing, and weaving.

In an exemplary embodiment of the present application, the process 400 for manufacturing an expanded solid prosthesis includes the following steps.

410: 3D modeling implants small bodies.

420: the implant small body is manufactured, and the expanded plate type material is put into intelligent forming equipment for processing.

430: the solid prosthesis is assembled and the implant corpuscles produced in step 420 are placed and secured in the mesh bag made in process flow 300.

440: inspecting the quality of the expanded solid prosthesis, sterilizing, classifying and packaging aseptically.

In an exemplary embodiment of the present application, the woven prosthesis manufacturing process flow 500 includes the following steps.

510: 3D modeling of the braided prosthesis.

520: producing the knitted prosthesis, processing the medical knitted silk by intelligent digital textile equipment, and manufacturing the knitted prosthesis.

530: inspecting the quality of the braided prosthesis, sterilizing, classifying and packaging aseptically.

The manufacturing process 600 of the hollow silica gel prosthesis for correcting vaginal relaxation according to the embodiment of the present application includes the following steps.

610: 3D modeling implants small bodies.

620: a small body series of molds were developed for implantation.

630: producing hollow silica gel implant bodies. The production method comprises the steps of immersing the small body implanting mould into liquid medical silica gel, and then demoulding to obtain the shell of the hollow silica gel implanted small body. The shells can also be manufactured in batches by adopting a 3D printing technology.

640: the shell is filled with the core material to make the implant corpuscle.

650: and assembling the hollow silica gel prosthesis.

660: checking the quality of the hollow silica gel prosthesis, sterilizing, classifying and packaging aseptically.

In one aspect of the application, a vaginal relaxation orthosis application is provided, comprising the following steps.

Step 1: and (3) evaluating the vaginal relaxation type and the relaxation degree of the patient, and selecting the model and the size of the vaginal relaxation corrective prosthesis.

Step 2: surgery creates a cavity between the vaginal mucosa and the muscle layer.

And step 3: and (4) inserting a vaginal relaxation correction prosthesis.

And 4, step 4: the prosthesis is fixed.

And 5: the incision is sutured and bandaged.

In an exemplary embodiment of the present application, in step 1, the use further comprises selecting to implant a vaginal relaxation orthosis suitable for the posterior vaginal wall when the patient is a simple vaginal soft tissue relaxation.

In an exemplary embodiment of the present application, in step 1, the method further comprises selecting a vaginal relaxation orthosis for implantation in the posterior and lateral walls of the vagina when the patient is relaxing the soft vaginal tissue and widening a portion of the pubic symphysis space.

In an exemplary embodiment of the present application, in step 1, the method further comprises selecting a vaginal relaxation orthosis for implantation in the posterior and lateral walls of the vagina when the patient has relaxed vaginal soft tissue and the pubic symphysis space has substantially widened.

In an exemplary embodiment of the present application, in step 1, the use further comprises using a thin vaginal laxity orthosis prosthesis when the patient is a patient with a slight laxity of the vaginal soft tissue.

In an exemplary embodiment of the present application, in step 1, the use further comprises using a medium thickness vaginal relaxation orthosis when the patient is a moderate relaxation of the vaginal soft tissue.

In an exemplary embodiment of the present application, in step 1, the use further comprises using a thick vaginal laxity orthosis prosthesis when the patient is severely lax in the vaginal soft tissue.

In an exemplary embodiment of the present application, in step 1, the method further comprises using a thickened vaginal relaxation orthosis when the patient is in a state of extreme laxity of the vaginal soft tissue.

In an exemplary embodiment of the present application, in step 1, the method further comprises applying a "bead" or "fence" like arrangement of the vaginal laxity orthosis when the patient is a laxity of the soft vaginal tissue with prolapse of the posterior vaginal wall.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.

(III) the beneficial effects.

(1) After the vaginal relaxation correction prosthesis is implanted, the prosthesis cannot slip off, and a long-term stable vaginal contraction effect can be obtained.

(2) The vaginal relaxation correction prosthesis is connected with the implanted small body into a cobblestone pavement-like grid structure through the lines, the lines are made of high-elasticity materials, so that the prosthesis has good extensibility and flexibility, and the patient implants the prosthesis without influencing gynecological examination, sexual behaviors or natural childbirth.

(3) The vaginal relaxation correcting prosthesis connects the implant small bodies into a fence-like arrangement structure through a rope, so that after the prosthesis is implanted, not only can the vaginal relaxation be corrected, but also the prolapse of the back wall of the vagina can be corrected.

(4) The vaginal relaxation correcting prosthesis comprises small implanted body models with different thicknesses, can correct patients with different vaginal relaxation degrees, and can combine patients with the widening of the pubic symphysis.

(5) The implanted corpuscle of the vaginal relaxation corrective prosthesis can trim part of the prosthesis to be implanted into the corpuscle according to individual conditions of patients in the application process, and can also be carved by a scalpel to adjust part of the prosthesis to be implanted into the corpuscle, thereby fully meeting the clinical requirements.

(6) The small implanted bodies of the vaginal relaxation correction prosthesis are provided with the strips, and the gaps are formed among the strips, so that the tissue healing adhesion is facilitated, and the position of the prosthesis is fixed.

(7) The skirt structure of the implanted capsule of the vaginal relaxation correction prosthesis can avoid or reduce capsular contracture formed around the prosthesis.

(8) The vaginal relaxation correction prosthesis comprises a suture fixing hole, and the prosthesis can be fixed by a suture or a rivet in the operation to prevent the prosthesis from moving.

(9) The small implanting body of the vaginal relaxation correction prosthesis is wrapped by the mesh bag, so that the implantation operation of the prosthesis is facilitated, and meanwhile, the displacement of the prosthesis can be avoided.

(10) The vaginal relaxation correcting prosthesis is made of soft polymer medical materials, and the high-convexity implanted corpuscles are arranged in the core area of the prosthesis, and the low-convexity implanted corpuscles are arranged in the peripheral area of the prosthesis, so that the prosthesis is free of obvious abrupt feeling and foreign body feeling after being implanted into a human body.

(11) The vagina relaxation correction prosthesis is manufactured by adopting a mature 3D modeling technology, a mould production technology, a medical spinning and weaving technology and a 3D printing technology, has simple process and easily obtained materials, is beneficial to large-scale batch production and reduces the manufacturing cost.

(12) The vaginal relaxation correcting prosthesis is simple to implant and operate, has small wound, has exact, stable and lasting effect of correcting vaginal relaxation or vaginal posterior wall prolapse, is easy to accept by patients and is easy to popularize and promote.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the present application and together with the description, serve to explain the principles of the application. It is obvious that the drawings in the following description are only some embodiments of the application, and that for a person skilled in the art, other drawings can be derived from them without inventive effort.

Fig. 1 schematically illustrates a top view of a "cobblestone pavement" like vaginal relaxation orthosis with which the present application may be applied.

Figure 2 schematically illustrates a top view of a "beaded" vaginal relaxation orthosis with which the present application may be used.

Figure 3 schematically illustrates a top view of a "fence" like vaginal relaxation orthosis with which the present application may be applied.

Fig. 4 schematically shows a cross-sectional structure of an implanted corpuscle to which the present application may be applied.

Fig. 5A schematically shows a hollow implant corpuscle cross-sectional structure to which the present application may be applied.

Fig. 5B schematically shows another cross-sectional structure of a hollow implant corpuscle to which the present application may be applied.

Fig. 6 schematically shows another implant corpuscle cross-sectional structure to which the present application may be applied.

Fig. 7 schematically illustrates an implanted corpuscle skirt construction to which the present application may be applied.

Fig. 8 schematically illustrates a cross-sectional structure of a vaginal relaxation orthosis including a mesh bag to which the present application may be applied.

Fig. 9 schematically illustrates a process flow for manufacturing a solid silicone vaginal relaxation orthosis in which the present application may be applied.

Fig. 10 schematically illustrates one vaginal laxity orthosis implantation procedure to which the present application may be applied.

Figure 11 schematically illustrates a vaginal relaxation orthosis of one type of the present application that can be used to correct mild vaginal relaxation.

Figure 12 schematically illustrates a vaginal relaxation orthosis to which one of the present applications may be applied for the treatment of moderate vaginal relaxation.

Figure 13 schematically illustrates a vaginal relaxation orthosis that can be used with one of the present applications to correct severe vaginal relaxation.

Figure 14 schematically illustrates a vaginal relaxation orthosis that can be used to correct one type of vaginal relaxation of the present application with a symphysis pubis widening.

Detailed Description

Example embodiments will now be described more fully with reference to the accompanying drawings. Example embodiments may, however, be embodied in many different forms and should not be construed as limited to the examples set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the concept of example embodiments to those skilled in the art. The described features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

It should be noted that the directional phrases in the present embodiment are only relative concepts or reference to the normal use status of the product, and should not be considered as limiting.

Furthermore, the drawings are merely schematic illustrations of the present application and are not necessarily drawn to scale. The same reference numerals in the drawings denote the same or similar parts, and thus their repetitive description will be omitted. Some of the block diagrams shown in the figures are functional entities and do not necessarily correspond to physically or logically separate entities.

Fig. 1 schematically illustrates a top view of a "cobblestone pavement" like vaginal relaxation orthosis with which the present application may be applied. As shown in fig. 1, the vaginal relaxation prosthesis of the embodiment of the present application may include a filling member and a cross-linking member, the filling member may include a plurality of implanted small bodies 10, the cross-linking member may include a plurality of strings 20, and the strings 20 may connect two adjacent implanted small bodies 10, such that the vaginal relaxation prosthesis is arranged in a lattice structure like a "cobblestone pavement".

It should be noted that the "cobblestone pavement" like lattice structure prosthesis of the embodiment of the present application shown in fig. 1 is exemplified by two rows of six implanted corpuscles 10, and in fact, the "cobblestone pavement" like lattice structure prosthesis may include three or more rows of implanted corpuscles 10, and each row may include two, four or more implanted corpuscles 10. In addition, the implanted corpuscles 10 may be arranged regularly, and the implanted corpuscles 10 may be arranged irregularly.

It should be noted that in the prosthesis with a grid structure like a cobblestone pavement, the implanted corpuscle 10 may be circular, elliptical, square, rectangular or irregular in the front plan view, but the implanted corpuscle 10 has no obvious edges and corners around the body, so as to avoid stabbing human tissues.

It should be noted that in the prosthesis having a lattice structure like a cobblestone pavement, the intervals between the implanted corpuscles 10 may be different, and accordingly, the lengths of the strings 20 connecting the implanted corpuscles 10 are changed.

In addition, the cord 20 may connect two adjacent implanted corpuscles 10, or may connect three or more adjacent implanted corpuscles 10.

It should be noted that the prosthesis size of the "cobblestone pavement" like grid structure can be set in a plurality of models so as to be suitable for different individuals. Typically the prosthesis size does not exceed 200 mm by 100 mm.

It should be noted that the filling component of the prosthesis with the "cobblestone pavement" like grid structure may include a core region and a peripheral region, the implanted corpuscles in the core region may generally have a larger volume, and the implanted corpuscles in the peripheral region may generally have a smaller volume, so that the surface of the vagina is smoother and has no obvious foreign body sensation after the prosthesis is placed in the human body.

It is understood that the prosthesis with the grid structure like the cobblestone pavement is usually arranged in a left-right symmetrical structure, and of course, the prosthesis with the left-right asymmetrical structure can also be arranged to meet the requirements of specific individuals.

Figure 2 schematically illustrates a top view of a "beaded" vaginal relaxation orthosis with which the present application may be used. As shown in FIG. 2, the "bead-string" type vaginal relaxation orthosis of the present embodiment may include a filling member and a cross-linking member, the filling member may include four implanted small bodies 10, the cross-linking member may include six strands 20, and two adjacent implanted small bodies 10 may be connected by two strands 20, such that the vaginal relaxation orthosis is arranged in a "bead-string" type structure.

It should be noted that the "bead string" like structure prosthesis filling component of the embodiment of the present application shown in fig. 2 is exemplified by four implanted corpuscles 10, and the cross-linking component is exemplified by six strings 20, in practical applications, the number of the implanted corpuscles 10 may be two or three, or more than four, two adjacent implanted corpuscles 10 may be connected by one string 20, and two adjacent implanted corpuscles 10 may be connected by three or more than three strings 20. In addition, the implanted corpuscles 10 may be arranged regularly, and the implanted corpuscles 10 may be arranged irregularly.

In the "bead string" type prosthesis, the front surface of the implanted small body 10 may be circular, elliptical or irregular in plan view, but the implanted small body 10 has no obvious edge angle, so as to avoid stabbing human tissues.

It should be noted that in a "beaded" prosthesis, the spacing between the implanted corpuscles 10 may vary, and accordingly, the length of the cord 20 connecting the implanted corpuscles 10 may vary.

It should be noted that the "beaded" construction prosthesis size can be provided in a number of sizes to accommodate different individuals. Typically the prosthesis size does not exceed 150 mm 80 mm.

It should be noted that the implanted corpuscles in the middle area of the prosthesis with the "bead string" like structure can be generally larger in volume, and the implanted corpuscles in the two side areas can be generally smaller in volume, so that the surface of the vagina is smoother and has no obvious foreign body sensation after the prosthesis is placed in a human body.

It will be appreciated that "beaded" like structures are typically provided in a side-to-side symmetric configuration, although non-symmetric versions of the side-to-side configuration may be provided to meet specific individual needs.

Figure 3 schematically illustrates a top view of a "fence" like vaginal relaxation orthosis with which the present application may be applied. As shown in FIG. 3, the "palisade" vaginal relaxation orthosis of the present embodiment may include a filling member and a cross-linking member, the filling member may include four implanted corpuscles 10, the cross-linking member may include six strands 20, and two adjacent implanted corpuscles 10 may be connected by two strands 20, such that the vaginal relaxation orthosis is arranged in a "palisade" configuration.

It should be noted that the "palisade" like structure prosthesis filling component of the embodiment of the present application shown in fig. 3 is exemplified by four implanted corpuscles 10, and the cross-linking component is exemplified by six cables 20, in practical applications, the number of the implanted corpuscles 10 may be two or three, or more than four, two adjacent implanted corpuscles 10 may be connected by one cable 20, and two adjacent implanted corpuscles 10 may be connected by three or more than three cables 20. In addition, the implanted corpuscles 10 may be arranged regularly, and the implanted corpuscles 10 may be arranged irregularly.

In the prosthesis with the fence-like structure, the implanted small body 10 can be elliptical or rectangular in the front plan view, but the implanted small body 10 has no obvious edges and corners, so that the human tissues are prevented from being punctured.

It should be noted that in the case of the "palisade" type prosthesis, the distance between the implanted corpuscles 10 may vary, and accordingly, the length of the cord 20 connecting the implanted corpuscles 10 varies.

It should be noted that the "cage" like structure prosthesis may be sized in a number of sizes to accommodate different individuals. Typically the prosthesis size does not exceed 150 mm 80 mm.

It should be noted that the implanted corpuscles in the middle area of the prosthesis with the fence-like structure can usually have larger volume, and the implanted corpuscles in the two side areas can usually have smaller volume, so that the surface of the vagina is smoother and has no obvious foreign body sensation after the prosthesis is placed in a human body.

It will be appreciated that prostheses of a "fence" like configuration are typically provided in a left-right symmetrical configuration, although models of left-right asymmetrical configurations may also be provided to meet the needs of a particular individual.

Fig. 4 schematically shows a cross-sectional structure of an implanted corpuscle to which the present application may be applied. As shown in fig. 4, the small implant 10 according to the embodiment of the present application may be a solid body, the small implant 10 may include a central region 11 and a marginal region 12, the central region 11 is obviously raised, the marginal region 12 is low and flat, and the convexity of the small implant 10 is gradually reduced from the highest point of the central region 11 to the outermost edge of the marginal region 12, so that the cross section of the small implant 10 is in an oval structure.

The cross section of the implanted corpuscle 10 has an oval structure, and the cross section of the implanted corpuscle 10 may have other shapes.

It should be noted that the long diameter of the implanted corpuscle 10 can be set to 5 mm-25 mm, the thickness of the central area of the implanted corpuscle 10 can be set to 2 mm-20 mm, and the thickness of the peripheral area of the implanted corpuscle 10 can be set to 0.25 mm-5 mm.

It will be appreciated that the major diameter of the implanted corpuscle 10 may be set to 10 mm-15 mm optimally, the thickness of the central zone of the implanted corpuscle 10 may be set to 5 mm-10 mm optimally, and the thickness of the peripheral zone of the implanted corpuscle 10 may be set to 0.5 mm-2 mm optimally.

It should be noted that, if the rope 20 is cylindrical, its diameter may be set to 0.2 mm to 5 mm and its length may be set to 0.5 mm to 10 mm. It will be appreciated that the diameter of the cord 20 may be optimally set to 0.2 mm-2.5 mm.

It should be noted that the implanted small body 10 can adopt medical silica gel with shore hardness of 0-30 degrees, so that the prosthesis is close to the softness of the soft tissue of the human body, and the strip cable 10 can adopt medical silica gel with shore hardness of 15-45 degrees, which gives consideration to the softness, the rigidity and the elasticity.

It is understood that other polymer medical materials or biomedical materials can be used for the implanted corpuscle 10, and other polymer medical materials or biomedical materials can be used for the cord 10.

Fig. 5A and 5B schematically show a cross-sectional structure of a hollow implant corpuscle to which the present application can be applied. As shown in fig. 5A and 5B, the implanted corpuscle 10 of the embodiment of the present application may be a hollow structure, and the implanted corpuscle 10 may include an outer shell 13, an inner capsule 14 and a core material 15, wherein the outer shell 13 encloses the inner capsule 14, and the core material 15 is arranged inside the inner capsule 14.

It should be noted that the central region 11 of the implanted corpuscle 10 with a hollow structure is obviously raised, the edge region 12 is low and flat, and the convexity of the implanted corpuscle 10 is gradually reduced from the highest point of the central region 11 to the outermost edge of the edge region 12.

It should be noted that the small implanted body 10 with a hollow structure can be circular, disc-shaped, square, rectangular or irregular, but the small implanted body 10 has no obvious edges and corners, so as to avoid stabbing human tissues.

It should be noted that the thickness of the outer shell 13 of the hollow implanted corpuscle 10 is usually set to 0.1 mm-1 mm, wherein the optimal thickness of the outer shell 13 is 0.2 mm-0.5 mm, the outer shell 13 of the hollow implanted corpuscle 10 can be medical silica gel with shore hardness of 10-45 degrees, or can be other high molecular medical materials or biomedical materials, and the core material 15 can be liquid medical gel or physiological saline, or can be other high molecular medical materials.

It will be appreciated that the inner capsule 14 of the implanted personal body 10, which is a hollow structure, may be filled with the core material 15, or may be partially filled with the core material 15.

Fig. 6 schematically shows another implant corpuscle cross-sectional structure to which the present application may be applied. As shown in fig. 6, the upper portion of the implanted corpuscle 10 of the embodiment of the present application may include a central region 11 and a rim region 12, the lower portion of the implanted corpuscle 10 may include a bottom 16, the convexity of the upper portion of the implanted corpuscle 10 gradually decreases from the highest point of the central region 11 to the outermost rim of the rim region 12, and the bottom 16 of the lower portion of the implanted corpuscle 10 approaches a planar structure.

It should be noted that the implanted small body 10 including the bottom 16 may include an outer shell 13, an inner capsule 14 and a core material 15.

It should be noted that the implanted body 10 including the base 16 may be applied to a "cobblestone" like prosthesis, as well as to a "beaded" like prosthesis or a "fence" like prosthesis.

It should be noted that the filling member of the "cobblestone pavement" like prosthesis, the "bead" like prosthesis or the "fence" like prosthesis may be constituted by the whole implanted corpuscle 10 including the bottom 16, or may be constituted by the whole implanted corpuscle 10 not including the bottom 16, or may be constituted by the implanted corpuscle 10 partially including the bottom 16 and the implanted corpuscle 10 partially not including the bottom 16.

It should be noted that the bottom 16 of the implanted corpuscle 10 may be oriented toward the mucosal layer 60 or toward the muscle layer 50 when the prosthesis is implanted in the body.

Fig. 7 schematically illustrates an implanted corpuscle skirt construction to which the present application may be applied. As shown in FIG. 7, the small implanted body 10 of the present embodiment may include a skirt 30, the skirt 30 annularly surrounding the outer edge of the small implanted body 10.

It should be noted that, as shown in the research, the skirt 30 is provided at the outer edge of the implanted small body 10, and the structure of the skirt 30 can reduce or prevent capsular contracture formed after the prosthesis is implanted into the human body, and the capsular contracture can cause slight change of the structure of the human tissue.

It should be noted that the skirt 30 of the implanted small body 10 can be generally set to have a thickness of 0.1 mm to 1 mm and a width of 0.5 mm to 2.5 mm.

It can be understood that the material for making the skirt 30 of the implanted corpuscle 10 can be selected to be the same as the material for making the implanted corpuscle 10 or the shell 13 of the implanted corpuscle 10, and the material can be made integrally, thereby simplifying the process and reducing the manufacturing cost.

Fig. 8 schematically illustrates a cross-sectional structure of a vaginal relaxation orthosis including a mesh bag to which the present application may be applied. As shown in fig. 8, the prosthesis of the present embodiment may comprise a mesh bag 40, and the mesh bag 40 may be wrapped around a "cobblestone" like or "bead" like or "fence" like arrangement of a plurality of implanted corpuscles 10 and cords 20, such that the prosthesis is an integral body.

It should be noted that the mesh gap size of the mesh bag 40 is limited by the incomplete exposure of the accommodated implanted small body 10, so as to prevent the implanted small body 10 from falling out of the mesh bag 40.

It should be noted that the mesh bag 40 may be made of degradable material that can be absorbed by human body, or may be made of non-degradable material.

It can be understood that the material for making the mesh bag 40 can be selected to be the same as the material for implanting the small body 10 or the shell 13 of the small body 10, and can be made integrally, thereby simplifying the process and reducing the manufacturing cost.

It should be noted that the mesh bag 40 may include a barb structure to prevent displacement of the prosthesis after it has been placed.

In addition, the mesh bag 40 may also function as a needle insertion hole, and may be used for suture fixation such as sutures and staples after the prosthesis is implanted. Of course, the small implant 10 near the incision side of the "cobblestone pavement" prosthesis can also be provided with a needle hole, and the small implant 10 near the incision side of the "bead" or "fence" prosthesis can be provided with a needle hole for suturing and fixing the prosthesis.

The vaginal relaxation corrective prosthesis of the embodiment of the application can be divided into three categories, namely, a solid prosthesis, a hollow prosthesis and a mixed prosthesis according to whether the implanted corpuscle 10 comprises the inner capsule 14, namely, the implanted corpuscle 10 which forms the prosthesis does not comprise the inner capsule 14 is the solid prosthesis, the implanted corpuscle 10 which forms the prosthesis comprises the inner capsule 14 is the hollow prosthesis, and the combined prosthesis is the mixed prosthesis, namely, the implanted corpuscle 10 which does not comprise the inner capsule 14 is also the implanted corpuscle 10 which comprises the inner capsule 14.

The solid prosthesis of the embodiment of the application can be divided into a silica gel solid prosthesis, an expanded solid prosthesis and a woven solid prosthesis according to different materials.

Fig. 9 schematically shows a manufacturing process flow of a vaginal relaxation-correcting solid silicone prosthesis to which the present application can be applied. As shown in fig. 9, the process flow 100 for manufacturing a silicone solid prosthesis according to the embodiment of the present application may include the following steps.

110: and 3D modeling of the silica gel solid prosthesis. And respectively designing and constructing a 3D model of the silica gel solid prosthesis according to the type, the model and the size of the vaginal relaxation correction prosthesis.

It should be noted that the vaginal relaxation orthopedic prosthesis can be divided into the following shapes: "cobblestone pavement" appearance prosthesis, "string of beads" appearance prosthesis, "fence" appearance prosthesis.

It should be noted that the vaginal relaxation orthosis can be divided into the following parts by the left and right length: small prosthesis, medium prosthesis, large prosthesis, and extra large prosthesis. In the case of "cobblestone pavement" like prostheses, typically the small size prostheses may be no more than 100 mm 50 mm, the medium size prostheses may be between 100 mm 50 mm and 150 mm 80 mm, the large size prostheses may be between 150 mm 50 mm and 200 mm 80 mm, and the large size prostheses may be more than 200 mm 80 mm.

It should be noted that the dimensions of the vaginal relaxation orthosis can be divided into the following categories, with respect to the convexity of the central zone 11 of the implanted corpus 10: thin prostheses, thick prostheses, thickened prostheses. Specifically, the shape of the implanted small body 10 can be a disk shape, a 'go' shape, a 'cobblestone' shape or other shapes, and the long diameter of the implanted small body 10 can be set to be 5 mm-25 mm. Taking the "cobblestone" type implanted corpuscle 10 as an example, the thickness of the central region of the implanted corpuscle 10 of a thin prosthesis can be set to be 2 mm to 5 mm, the thickness of the central region of the implanted corpuscle 10 of a thick prosthesis can be set to be 5 mm to 10 mm, and the thickness of the central region of the implanted corpuscle 10 of a thicker prosthesis can be set to be 10 mm to 20 mm. In addition, the thickness of the rim area of the implanted small body 10 can be set to 0.25 mm to 5 mm in general.

It will be appreciated that the major diameter of the implanted corpuscle 10 may be set to 10 mm-15 mm and the thickness of the rim area of the implanted corpuscle 10 may be set to 0.5 mm-2 mm.

It should be noted that, if the rope 20 is cylindrical, its diameter may be set to 0.2 mm to 2.5 mm and its length may be set to 0.5 mm to 10 mm.

It will be appreciated that the three categories of vaginal relaxation orthosis described above may be combined into more types of prosthesis to meet clinical needs.

120: and developing a silica gel solid prosthesis mould. And respectively opening molds according to the 3D models of the silica gel solid prosthesis with different types and sizes designed in the step 110, thereby forming a series of silica gel solid prosthesis molds.

It should be noted that after developing the mold for the silicone solid prosthesis, the mold is usually tested, and if necessary, the mold needs to be modified.

The surface of the silica gel solid prosthesis die can be provided with lines, so that the surface layer of the final product silica gel solid prosthesis forms a rough surface, and the prosthesis is lightened or prevented from moving after being placed into a human body.

It is understood that step 125 may be further included, and step 125 may be performed by using 3D printing technology to mass-produce different types and sizes of silicone solid prostheses, and step 120 may not be required.

130: producing the silica gel solid prosthesis. The forming method can comprise compression molding and injection molding.

It should be noted that the solid silica gel prosthesis can adopt medical silica gel with shore hardness of 0-60 degrees, and the medical silica gel with shore hardness of 0-30 degrees is optimally selected, so that the prosthesis is close to the softness of human soft tissues.

It should be noted that 3D printing technology can also be used to mass-produce different types and sizes of solid silica gel prostheses, and the printing material is selected from silica gel.

140: the quality of the silicone solid prosthesis was checked. The inspection items at least comprise the indexes of the appearance, the microstructure, the size, the softness, the elasticity and the like of the silica gel solid prosthesis, so that the inspection items meet the national quality standard of the silica gel prosthesis placed in the body.

150: and (5) sterilizing the silica gel solid prosthesis. At least comprises cleaning, sterilizing, heat source removing and the like so as to meet the national aseptic requirement of the in-vivo placement of the silica gel prosthesis.

160: and classifying and aseptically packaging the silica gel solid prosthesis. The package at least comprises a name, a model, a size, a generation date, a expiration date, a purpose and the like, so that the package meets the national packaging requirements of the body built-in silica gel prosthesis.

It should be noted that, in step 110, when the silicone solid prosthesis is modeled in 3D, the implanted small body 10 may further include a skirt 30, and the skirt 30 may have a thickness of 0.1 mm to 1 mm and a width of 0.5 mm to 2.5 mm. Correspondingly, when the die is opened in the step 120, the die for the solid silica gel prosthesis has a skirt 30 structure, and the solid silica gel prosthesis is produced in the step 130 and has the skirt 30 structure. Of course, when the 3D printing technology is used to manufacture the silica gel solid prosthesis, the mold opening step 120 is not required.

It should be noted that step 130 may further include a step of perforating the silicone solid prosthesis. Specifically, after the solid silica gel prosthesis is generated, the solid silica gel prosthesis enters a drilling process of the implanted corpuscle 10, the drilling process can include laser drilling of the solid silica gel prosthesis and drilling of the solid silica gel prosthesis, the solid silica gel prosthesis is placed in laser drilling or drilling equipment, the equipment identifies that the solid silica gel prosthesis is implanted into the corpuscle 10 according to a preset program, and pores with a certain depth are formed in the implanted corpuscle 10 according to a certain distance. The purpose of perforating the silicone solid prosthesis can allow human tissues to grow into the pores of the implanted corpuscle 10 to avoid displacement of the prosthesis on one hand, and can increase the flexibility of the prosthesis on the other hand. Certainly, when the 3D printing technology is adopted to manufacture the silica gel solid prosthesis with pores, no additional punching process is needed, and only in step 110, the small body 10 is implanted with pores with certain spacing, pore diameter and pore depth when the silica gel solid prosthesis is modeled in a 3D mode.

It should be noted that, in step 110, when the silica gel solid prosthesis is modeled in 3D, the implanted small body 10 may further include a barb structure, and correspondingly, when the mold is opened in step 120, the silica gel solid prosthesis mold has the barb structure, and in step 130, the silica gel solid prosthesis with the barb structure is produced. Of course, when the 3D printing technology is used to manufacture the silicone solid prosthesis with barbs, it is only necessary that in step 110, the implanted small body 10 has a barb structure during 3D modeling of the silicone solid prosthesis.

It should be noted that, in step 110, when the silica gel solid prosthesis is modeled in 3D, the implanted corpuscle 10 in the edge area of the prosthesis may further include a needle insertion hole structure, and correspondingly, when the mold is opened in step 120, the mold of the silica gel solid prosthesis has the needle insertion hole structure, and in step 130, the silica gel solid prosthesis having the needle insertion hole structure is produced. Of course, when the 3D printing technology is used to manufacture the solid silica gel prosthesis with the needle insertion hole structure, it is only necessary that in step 110, the implanted small body 10 has the needle insertion hole structure when the solid silica gel prosthesis is modeled in a 3D manner.

As shown in fig. 9, another manufacturing process flow 200 of the silicone solid prosthesis of the embodiment of the present application may include the following steps.

210: the 3D modeling may include modeling of the implanted corpuscles 10, modeling of the cord 20.

It should be noted that the small body 10 can be implanted in a low convex implant 10, a medium convex implant 10, or a high convex implant 10. Specifically, the shape of the implanted small body 10 can be a disk shape, a 'go' shape, a 'cobblestone' shape or other shapes, and the long diameter of the implanted small body 10 can be set to be 5 mm-25 mm. Taking the "cobblestone" type implanted corpuscle 10 as an example, the thickness of the central region of the low convex implanted corpuscle 10 can be set to be 2 mm-5 mm, the thickness of the central region of the medium convex implanted corpuscle 10 can be set to be 5 mm-10 mm, and the thickness of the central region of the high convex implanted corpuscle 10 can be set to be 10 mm-20 mm. In addition, the thickness of the rim area of the implanted small body 10 can be set to 0.25 mm to 5 mm in general.

It should be noted that the cord 20 may comprise a cylindrical shape, a ribbon shape, and in the case of a cylindrical shape, the diameter may be generally set to 0.2 mm to 2.5 mm, and the length may be several hundred millimeters or more.

220: a model of the implanted corpuscle 10 and the cord 20 was developed.

It should be noted that the surface of the mold for implanting the small body 10 may be provided with lines, barb structures, or skirt structures.

It will be appreciated that if the 3D printing technique is used to mass produce different types and sizes of the implant corpuscle 10, the string 20 mold, step 220 may not be required.

230: producing an implanted corpuscle 10 and a cord 20.

It should be noted that the implanted corpuscle 10 may be made of medical silica gel with shore hardness of 0-30 degrees, and the cord 20 may be made of medical silica gel with shore hardness of 15-45 degrees.

It should be noted that, in the steps, the drilling process of the implanted corpuscle 10 is added, and a hole is made on the implanted corpuscle 10.

It should be noted that the implanted corpuscles 10 and the cord 20 can be manufactured in batch by using 3D printing technology, and the printing material is selected from silicone.

240: assembling the silicone solid prosthesis may include the following steps.

242: the implanted corpuscle 10 is prepared and placed according to the shape and convexity of the implanted corpuscle 10.

244: the cord 20 is cut to the desired length.

246: and combining and bonding the silica gel solid prosthesis. Selecting the implant small body 10, and respectively assembling a thin prosthesis, a thick prosthesis and a thickened prosthesis according to the cobblestone pavement-like prosthesis, the bead-like prosthesis, the fence-like prosthesis type and the size of the small prosthesis, the medium prosthesis, the large prosthesis and the extra large prosthesis.

250: checking the quality of the silica gel solid prosthesis, sterilizing, classifying and packaging aseptically.

The process flow 300 for manufacturing the mesh prosthesis bag 40 according to the embodiment of the present application may include mold pressing, mold injection, 3D printing, and weaving.

It should be noted that, the manufacturing of the mesh prosthesis bag 40 needs to be based on the model size data of the vaginal relaxation orthodontic prosthesis, and 3D modeling.

It should be noted that, the mold pressing and mold injection for manufacturing the mesh bag for prosthesis 40 requires opening a mold based on 3D modeling, and then performing the mold pressing and mold injection for manufacturing the mesh bag 40.

It should be noted that the 3D printing for making the mesh prosthesis bag 40 needs to be made by a 3D printer based on 3D modeling.

The weaving needs to be made by intelligent spinning weaving equipment on the basis of 3D modeling.

It should be noted that the material for making the mesh bag 40 may be medical silica gel, medical degradable polymer material, medical biomaterial, bulking material, woven material, etc.

The process flow 400 for manufacturing an expanded solid prosthesis according to embodiments of the present disclosure may include the following steps.

410: the 3D modeling implants the corpuscle 10.

It should be noted that the small body 10 can be implanted in a low convex implant 10, a medium convex implant 10, or a high convex implant 10. The implanted corpuscle 10 may have a shape of a disk, a "go," a "cobblestone," a rectangle, or other shapes.

420: an implanted corpuscle 10 is made. The expanded sheet material is placed in an intelligent forming tool and the modeling data is received 410 to produce the implant body 10.

It should be noted that the porosity of the material of the expanded plate type is usually greater than 85%, which is beneficial for the human tissue to grow into the implanted small body 10, and avoids the displacement of the prosthesis.

It should be noted that, in step 420, the implanted corpuscles 10 can also be mass-produced by using a 3D printer.

430: assembling the bulked solid prosthesis. The small implant 10 fabricated in step 420 is placed and secured in the appropriate mesh bag 40 fabricated in process flow 300, thereby obtaining a "cobblestone" like prosthesis, "beaded" like prosthesis, "fenced" like prosthesis type and size for small, medium, large, and extra large prostheses, which can be assembled into thin, thick, and thickened prostheses.

440: inspecting the quality of the expanded solid prosthesis, sterilizing, classifying and packaging aseptically.

The process 500 for manufacturing a lax vagina correction braided prosthesis according to the embodiments of the present application may include the following steps.

510: 3D modeling of the braided prosthesis.

It should be noted that the small body 10 can be implanted in a low convex implant 10, a medium convex implant 10, or a high convex implant 10.

It should be noted that the cord 20 may comprise a cylindrical shape, a ribbon shape, and in the case of a cylindrical shape, the diameter thereof may be set to be generally 0.2 mm to 2.5 mm.

520: producing a braided prosthesis. The medical braided silk is processed by intelligent digital textile equipment to manufacture the braided prosthesis.

It should be noted that the medical braided wire material can be a single non-degradable material, or a braided wire formed by mixing a non-degradable material and a degradable material.

It should be noted that the braiding process allows for good extensibility of the strands 20 of the cross-linked components of the prosthesis.

It will be appreciated that medical filament materials are generally required to have a bulky structure, with good flexibility.

530: inspecting the quality of the braided prosthesis, sterilizing, classifying and packaging aseptically.

The process 600 for manufacturing a hollow silicone prosthesis for correcting vaginal relaxation according to the embodiment of the present application may include the following steps.

610: the 3D modeling implants the corpuscle 10. According to the type, model and size of the vaginal relaxation correction prosthesis, a 3D model of the implanted corpuscle 10 is designed and constructed respectively.

620: a series of molds for implanting corpuscles 10 were developed.

630: hollow silica gel is produced to implant the corpuscle 10. The production method can include that the body 10 is implanted into a mould, the mould is immersed into liquid medical silica gel, and then demoulding is carried out, so that the shell 13 of the hollow silica gel implanted body 10 is obtained.

It should be noted that, liquid medical silica gel may also be sprayed to the mold of the implanted corpuscle 10, and then the mold is removed to obtain the outer shell 13 of the hollow silica gel implanted corpuscle 10.

It should be noted that the 3D printing technology may also be used to fabricate the housing 13 in batch, so that the step 620 of developing a mold is not required.

640: the shell 13 is filled with the core material 15 to make the implanted corpuscle 10. The core material 15 may comprise a medical hydrogel, medical high cross-linking hyaluronic acid, saline, or other medical material.

650: and assembling the hollow silica gel prosthesis. The implant corpuscle 10 manufactured in step 640 is placed and fixed in the mesh bag 40 manufactured in the process flow 300, so that a "cobblestone pavement" -like prosthesis, "bead" -like prosthesis, "fence" -like prosthesis type and size for small, medium, large and extra large prostheses can be obtained, thin, thick and thickened prostheses can be assembled.

660: checking the quality of the hollow silica gel prosthesis, sterilizing, classifying and packaging aseptically.

In step 640, the outer shell 13 may be filled with the core material 15, or may be partially filled with the core material 15.

It should be noted that step 650 may be performed to place and secure the shell 13 in the appropriate mesh bag 40 made in the process 300 to obtain an unfilled prosthesis. And step 640, filling the core material 15 into the shell 13 to manufacture hollow silica gel prostheses in batch.

It should be noted that step 650 may be performed to place and secure the shell 13 in the appropriate mesh bag 40 made in the process 300 to obtain an unfilled prosthesis. Then, in the operating room of the hospital, the core material 15 is filled in the shell 13 by the surgeon according to the actual needs of the patient.

It will be appreciated that the 3D modeled implanted corpuscle 10 in step 610 may include a skirt 30 such that the housing 13 produced in step 640 has a skirt 30.

In addition, in step 650, the hollow silicone prosthesis is assembled by connecting the implant bodies 10 manufactured in step 640 with the cord 20 to obtain a series of hollow silicone prostheses.

In addition, the silica gel implanted corpuscle 10 produced by the process flow 200, the expanded implanted corpuscle 10 produced by the process flow 300, and the hollow implanted corpuscle 10 produced by the process flow 600 can be mixed, placed and fixed in the mesh bag 40 manufactured by the process flow 300, so as to obtain the mixed prosthesis.

Fig. 10 schematically illustrates one vaginal laxity orthosis implantation procedure to which the present application may be applied. As shown in fig. 10, a vaginal relaxation orthosis application process 700 of an embodiment of the present application includes the following steps.

710: the patient is assessed for vaginal relaxation type and degree of relaxation.

It should be noted that if perineal trauma and natural birth canal delivery are experienced, assessment of vaginal relaxation needs to be performed after complete repair of perineal trauma and post-partum recovery.

It should be noted that the vaginal relaxation is a relative concept, and the evaluation of the vaginal relaxation degree depends on the matching degree of the vaginal volume and the genital organ size of the sexual partner and the sexual life experience feeling, and can be divided into mild vaginal relaxation, moderate vaginal relaxation and severe vaginal relaxation according to the vaginal relaxation degree. If the vagina has prolapse, it is generally characterized by severe vaginal relaxation.

It should be noted that the type of vaginal relaxation can be divided into no-widening vaginal relaxation at the pubic symphysis interval, moderate-widening vaginal relaxation at the pubic symphysis interval, and significant-widening vaginal relaxation at the pubic symphysis interval according to the distance between the pubic symphysis.

720: and selecting the proper vaginal relaxation correction prosthesis model and size.

It should be noted that the vaginal relaxation orthopedic prosthesis can be divided into the following shapes: "cobblestone pavement" appearance prosthesis, "string of beads" appearance prosthesis, "fence" appearance prosthesis.

It should be noted that the vaginal relaxation orthosis can be divided into the following parts by the left and right length: small prosthesis, medium prosthesis, large prosthesis, and extra large prosthesis.

It should be noted that the dimensions of the vaginal relaxation orthosis can be divided into thin prosthesis, thick prosthesis, and thick prosthesis by the convexity of the central region 11 of the implanted corpus 10.

Therefore, the three vaginal relaxation correction prostheses are classified and combined into more types of prostheses so as to meet the clinical requirements.

It should be noted that after the patient assessment data is obtained in step 710, the one of the prostheses that is closest to the actual needs of the patient is selected from the library of vaginal relaxation orthosis products, depending on the individual condition of the patient. Of course, if there is no prosthesis in the product library of vaginal laxity correction prostheses that is suitable for the actual needs of the patient, it is usually necessary to order the manufacturer, and the patient can take a custom-made prosthesis.

730: surgery creates a cavity between the vaginal mucosa and the muscle layer.

It will be appreciated that the patient is subjected to surgery with surgical indications, the patient is placed in a cystectomy, the procedure is performed under anesthesia, and the incision is typically selected at the mucosal-skin interface between 3 and 9 points of the vagina, separated in the potential space between the mucosal layer 60 and the muscle layer 50, creating a cavity, the size of which depends on the predetermined separation.

It will be appreciated that the predetermined separation range is typically slightly larger than the size of the prosthesis selected in step 720.

It is understood that the surgical approach may include scalpel separation, water knife separation, electrotome separation, ultrasonic knife separation.

740: and (4) inserting a vaginal relaxation correction prosthesis.

It should be noted that the prosthesis is carefully checked before the prosthesis is placed.

It will be appreciated that the prosthesis is rolled into a tubular shape to fit into the compartment formed in step 730, and therefore, the incision need not be too large, but may not be too small, to allow easy passage of the rolled prosthesis into a tubular shape when forming the compartment in step 730.

It should be noted that after the prosthesis is inserted, the prosthesis is adjusted in position, and the prosthesis can be flattened into a tubular shape by a surgical instrument, and the position of the prosthesis is adjusted so that the strings 20 of the prosthesis are usually positioned at 6 o' clock in the vagina.

It is understood that after the prosthesis is implanted, if the prosthesis is found to be too large, a certain number of the implanted corpuscle 10 and the cord 20 can be cut off, or the implanted corpuscle 10 can be carved to modify the shape and thickness thereof.

It will be appreciated that after insertion of the prosthesis, if the prosthesis is found to be smaller or of the wrong type, a more suitable prosthesis may be replaced.

It will be appreciated that after insertion of the prosthesis, if the compartment created in step 730 is found to be too small, the prosthesis may be removed and the compartment further separated until the compartment fits the prosthesis.

750: and fixing the vaginal relaxation correction prosthesis.

It should be noted that if the selected prosthesis has a barbed configuration, the prosthesis may be secured by pressing the barbed configuration into tight engagement with the mucosal layer 60 and the muscle layer 50 after step 740 is completed.

It should be noted that the prosthesis fixing points include at least two, and the prosthesis fixing manner may include suture fixing, glue adhering fixing or other fixing.

It will be appreciated that the effect of the prosthesis anchoring can be checked by gently pushing the prosthesis.

760: the incision is sutured and pressure bandaged.

It should be noted that after the prosthesis has been positively secured in step 750, the incision in step 730 may be sutured.

It should be noted that, after operation, it is usually necessary to perform local pressure dressing to avoid the secondary bleeding and edema after operation.

It will be appreciated that the incision stitching may include suture stitching, staple stitching, glue bonding, or other fastening.

Figure 11 schematically illustrates a vaginal relaxation orthosis of one type of the present application that can be used to correct mild vaginal relaxation. As shown in fig. 11, in the embodiment of the present application, if the soft tissue of the vagina is simply relaxed in mild-moderate degree, the left and right vaginal diameter and the upper and lower vaginal channels are close, and the combined pubic symphysis gap is not widened, a small-size thin prosthesis or a medium-thick prosthesis can be selected, the surgical incision can be selected between 5 and 7 points of the vagina, and the prepared lacuna between the mucosa layer 60 and the muscle layer 50 can be between 4 and 8 points of the vagina or slightly exceed the range between 4 and 8 points of the vagina.

It should be noted that, according to the needs of the patient, a small-size thick prosthesis can be selected to achieve a more compact effect.

It will be appreciated that the surgical incision may alternatively be chosen between 5 and 6 points or between 6 and 7 points of the vagina, the size of the incision being such that the prosthesis can be easily placed in the rolled tubular shape, and the incision being further reduced if the creation of the lacuna is carried out with the aid of an endoscope.

Figure 12 schematically illustrates a vaginal relaxation orthosis to which one of the present applications may be applied for the treatment of moderate vaginal relaxation. As shown in fig. 12, in the embodiment of the present application, if the soft tissue of the vagina is simple and moderate, the left and right vaginal diameters are close to the upper and lower vaginal diameters, or the left and right vaginal diameters are slightly wider than the upper and lower vaginal diameters, and the combined pubic symphysis gap is not widened, a medium-sized and thick prosthesis can be selected, the surgical incision can be selected between 5 points and 7 points of the vagina, and the prepared lacuna between the mucosa layer 60 and the muscle layer 50 can be between 3 points and 9 points of the vagina or slightly exceed the range between 4 points and 8 points of the vagina.

It should be noted that, according to the needs of the patient, a medium-sized thick prosthesis can be selected, so as to achieve a more compact effect.

It will be appreciated that the surgical incision may alternatively be chosen between 5 and 6 points or between 6 and 7 points of the vagina, the size of the incision being such that the prosthesis can be easily placed in the rolled tubular shape, and the incision being further reduced if the creation of the lacuna is carried out with the aid of an endoscope.

Figure 13 schematically illustrates a vaginal relaxation orthosis that can be used with one of the present applications to correct severe vaginal relaxation. As shown in figure 13, in the embodiment of the present application, the soft tissue of the vagina with heavy degree is relaxed, the left and right diameter of the vagina is widened compared with the upper and lower channels, the combined light and medium pubic symphysis space is widened, a large and medium-thick prosthesis can be selected, the surgical incision can be selected between 4 points and 8 points of the vagina, and the prepared lacuna between the mucosa layer 60 and the muscle layer 50 can be close to between 3 points and 9 points of the vagina or slightly exceed the range between 3 points and 9 points of the vagina.

It should be noted that, according to the needs of the patient, a large-size thick prosthesis can be selected to achieve a more compact effect.

It will be appreciated that the surgical incision may alternatively be selected to be between 5 and 7 points of the vagina, the size of the incision being such that the rolled tubular prosthesis can be easily inserted, and the incision can be further reduced if the lacuna is created with the aid of an endoscope.

Figure 14 schematically illustrates a vaginal relaxation orthosis that can be used to correct one type of vaginal relaxation of the present application with a symphysis pubis widening. As shown in figure 14, in the embodiment of the present application, for severe vaginal soft tissue relaxation and significant pubic symphysis space widening, the left and right vaginal diameter is significantly widened compared to the upper and lower vaginal diameter, a large-size thick prosthesis can be selected, the surgical incision can be selected between 4 and 8 points of the vagina, and the prepared lacuna between the mucosa layer 60 and the muscle layer 50 can be close to between 2 and 11 points of the vagina or slightly exceed the range between 1 and 11 points of the vagina.

It should be noted that, according to the needs of the patient, the thickened prosthesis with a larger size can be selected to achieve a more compact effect.

It will be appreciated that two or three surgical incisions may be selected to accommodate the need to separate the cavity between the larger mucosal layer 60 and the muscle layer 50.

It should be noted that care was taken to protect the urethra when creating the separation cavity, near point 0 of the vagina.

It will be appreciated that the cut can be further reduced if the creation of the cavity is carried out with the aid of an endoscope.

It will be appreciated that, in order to solve the problem of difficult insertion of the large prosthesis, if necessary, a portion of the cord 20 may be cut off, so that the large prosthesis is divided into two or three small prostheses, and after the small prostheses are inserted into the lacuna, the small prostheses are fixed by means of suturing, which may also achieve a similar effect.

In addition, when the patient is the laxity of the vagina soft tissue and the prolapse of the back wall of the vagina, the fence-like vaginal laxity correction prosthesis can be selected to achieve the effect of correcting the laxity of the vagina soft tissue and the prolapse of the back wall.

It should be noted that although several steps for method flow execution are mentioned in the above detailed description, such partitioning is not mandatory.

Other embodiments of the present application will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. This application is intended to cover any variations, uses, or adaptations of the invention following, in general, the principles and including such departures from the present disclosure as come within known or customary practice within the art to which the invention pertains. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the disclosure being indicated by the following claims.