CN115590654B - Degradable implant for preventing intrauterine adhesion and preparation method thereof - Google Patents

Abstract

The invention discloses a degradable implant for preventing intrauterine adhesion and a preparation method thereof, and relates to the technical field of medical instruments. The degradable implant is composed of a concave wrinkled elastic monomer, wherein the concave wrinkled elastic monomer expands and shrinks in the circumferential and axial directions of the degradable implant; When the degradable implant is not stretched, the geometric shape of the degradable implant matches the contour of the patient's uterine cavity; after the degradable implant is stretched, the degradable implant The geometric shape of the object is deformed into a cylindrical shape. In the present invention, the degradable implant is composed of a concave pleated elastic monomer, so that the degradable implant can fit well with the wall of the uterine cavity, and at the same time, it also improves the convenience of the placement operation of the degradable implant. Sex, which can effectively reduce the possibility of recurrence of intrauterine adhesions in patients after surgery.

Description

Degradable implant for preventing intrauterine adhesions and preparation method thereof

technical field

The invention relates to the technical field of medical devices, in particular to a degradable implant for preventing intrauterine adhesions and a preparation method thereof.

Background technique

Due to the gradual increase in clinical uterine surgery such as induced abortion, uterine adhesion separation, uterine fibroids, mediastinum, endometrial polypectomy, and uterine deformity plastic surgery, factors such as uterine surgery or secondary infection are likely to cause uterine abnormalities. Irreversible damage to the basal layer of the endometrium causes the pathological symptoms of partial or total mutual adhesion of the uterine cavity wall. At the same time, intrauterine adhesions will further damage the endometrium of the uterine cavity, reduce the volume of the uterus, affect the normal implantation of embryos, and easily lead to repeated miscarriages, premature births, and even infertility. This has become an urgent clinical problem in obstetrics and gynecology.

At present, in the clinical treatment of intrauterine adhesions, hysteroscopic separation of intrauterine adhesions is often used, and physical barriers such as intrauterine devices, balloon stents, Foley double-lumen catheters, and COOK silicone balloon stents are placed during the operation, or Inject drugs (hyaluronic acid, chitosan, estrogen and progesterone, polylactic acid gel), or a combination of drugs and stents. Its purpose is to release intrauterine adhesions, restore the normal anatomical shape of the uterine cavity, and promote endometrial regeneration and reproductive function. Although the existing methods have achieved a certain clinical effect, patients with moderate to severe intrauterine adhesions are prone to recurrence after surgery, and the rate of re-adhesion is as high as 62.5%, resulting in a postoperative pregnancy rate of only 22.5%-33.3%. Therefore, how to reduce the risk of hysteroscopy Re-adhesion has become the focus of clinical attention and a difficult problem.

The existing physical barriers placed after intrauterine adhesions generally have implants that are difficult to fit well with the patient's uterine cavity wall, so on the one hand, it is difficult to fully isolate the wound on the uterine cavity wall; The uniform pressure on the wall of the uterine cavity can also easily cause insufficient subendometrial blood supply in different areas of the uterine cavity wall, which is not conducive to the regeneration and repair of the endometrium, thus making it difficult to reduce the possibility of recurrence of intrauterine adhesions in patients after surgery.

Contents of the invention

The main purpose of the present invention is to provide a method for preparing a degradable implant for preventing intrauterine adhesions, which aims to solve the problem that the existing physical barrier placed after intrauterine adhesions is difficult to reduce the possibility of recurrence of postoperative intrauterine adhesions in patients technical problems.

In order to achieve the above purpose, the present invention provides a degradable implant for preventing intrauterine adhesions. The degradable implant is composed of a concave wrinkled elastic monomer, wherein the concave wrinkled elastic monomer is in the The circumferential and axial expansion and contraction deformation of the degradable implant; when the degradable implant is not stretched, the geometric shape of the degradable implant is consistent with the contour of the patient's uterine cavity Matching; after the degradable implant is stretched, the geometry of the degradable implant deforms into a cylindrical shape.

Optionally, the composition material of the degradable implant is a matrix material and a specified drug, wherein the matrix material is a degradable polymer or a composite material of the degradable polymer and a degradable bioceramic, in the The outer surface or inner part of the matrix material is loaded with the specified drug.

Optionally, the degradable polymer is at least one of polylactic acid, polycaprolactone and polylactic-co-glycolic acid copolymer; the degradable bioceramic is at least one of calcium silicate, calcium phosphate and bioglass One; the mass fraction of degradable bioceramics in the composite material ranges from 0-50wt%.

Optionally, the specified drug includes at least one of estrogen, antibacterial drugs and growth factors.

Optionally, the concave pleated elastic monomers are connected by arc-shaped connecting beams.

Optionally, the end of the degradable implant close to the bottom of the uterine cavity is provided with a stretch retaining ring for preventing fluid leakage.

Optionally, the stretch retaining ring is provided with an external interface for connecting with a drainage device to drain the effusion.

Optionally, the initial degradation rate of the degradable implant is lower than 0.15mm/y, the medium-term degradation rate is 0.15-0.4mm/y, and the long-term degradation rate is greater than 0.4mm/y, until the degradable implant The substance is completely degraded.

In order to achieve the above object, the present invention also provides a preparation method of a degradable implant for preventing intrauterine adhesions, the preparation method comprising:

Obtain the patient's uterine cavity information;

Generate a corresponding implant model according to the uterine cavity information;

The degradable implant corresponding to the implant model is prepared by additive manufacturing, wherein the degradable implant is composed of a concave wrinkled elastic monomer, and the concave wrinkled elastic monomer is placed on the desirable circumferential and axial expansion and contraction deformation of the degradable implant; when the degradable implant is not stretched, the geometry of the degradable implant matches the contour of the patient's uterine cavity; After the degradable implant is stretched, the geometric shape of the degradable implant deforms into a cylindrical shape.

Optionally, the step of generating a corresponding implant model according to the uterine cavity information includes:

According to the information of the uterine cavity, determine the curved surface of the endometrium of the uterine cavity to be covered, and use the curved surface of the endometrium of the uterine cavity to expand the contour boundary within the first preset distance range in the direction of the submembranous normal as the patient's uterine cavity. Cavity profile;

According to the outline of the uterine cavity, an implant model corresponding to the outline of the patient's uterine cavity is generated.

The present invention proposes a degradable implant for preventing intrauterine adhesions. The degradable implant is composed of a concave wrinkled elastic monomer, wherein the concave wrinkled elastic monomer is placed in the degradable implant The circumferential and axial expansion and contraction deformation of the object. Therefore, when the degradable implant is not stretched based on the concave pleated elastic monomer, the geometric shape of the degradable implant matches the contour of the patient's uterine cavity; After the degradable implant is stretched, the geometric shape of the degradable implant is transformed into a cylindrical shape. Therefore, the present invention adopts the concave pleated elastic monomer to form the degradable implant, so that the degradable implant can fit well with the patient's uterine cavity wall, and at the same time improve the quality of the degradable implant. The convenience of the placement operation can effectively reduce the possibility of recurrence of intrauterine adhesions in patients after surgery. In addition, the implant used in the present invention is a degradable implant, so it can avoid multiple placements and removals to increase operational complexity and form new wounds, and improve the use safety of the degradable implant.

Description of drawings

Figure 1 is a schematic structural view of the degradable implant for preventing intrauterine adhesions involved in the embodiment of the present invention;

Fig. 2 is a schematic diagram of tensile deformation of the degradable implant for preventing intrauterine adhesions involved in the embodiment of the present invention;

Fig. 3 is a schematic flowchart of the first embodiment of the preparation method of the degradable implant for preventing intrauterine adhesions of the present invention.

The realization, functional features and advantages of the present application will be further described in conjunction with the embodiments and with reference to the accompanying drawings. These drawings and text descriptions are not intended to limit the scope of the concept of the application in any way, but to illustrate the concept of the application for those skilled in the art by referring to specific embodiments.

Detailed ways

It should be understood that the specific embodiments described here are only used to explain the present invention, not to limit the present invention.

The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some of the embodiments of the present invention, but not all of them. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of the present invention.

The term "and/or" in this article is just an association relationship describing associated objects, which means that there can be three relationships, for example, A and/or B can mean: A exists alone, A and B exist simultaneously, and there exists alone B these three situations.

The terms "first" and "second" in the description and claims of the embodiments of the present invention are used to distinguish different objects, rather than to describe a specific sequence of objects. For example, the first target object, the second target object, etc. are used to distinguish different target objects, rather than describing a specific order of the target objects.

In the embodiments of the present invention, words such as "exemplary" or "for example" are used as examples, illustrations or illustrations. Any embodiment or design solution described as "exemplary" or "for example" in the embodiments of the present invention shall not be construed as being more preferred or more advantageous than other embodiments or design solutions. Rather, the use of words such as "exemplary" or "such as" is intended to present related concepts in a concrete manner.

In the description of the embodiments of the present invention, unless otherwise specified, "plurality" means two or more. For example, multiple processing units refer to two or more processing units; multiple systems refer to two or more systems.

In order to describe the following embodiments clearly and concisely, a brief introduction of the existing physical barriers placed after intrauterine adhesions is firstly given:

Due to the gradual increase in clinical uterine surgery such as induced abortion, uterine adhesion separation, uterine fibroids, mediastinum, endometrial polypectomy, and uterine deformity plastic surgery, factors such as uterine surgery or secondary infection are likely to cause uterine abnormalities. Irreversible damage to the basal layer of the endometrium causes the pathological symptoms of partial or total mutual adhesion of the uterine cavity wall. At the same time, intrauterine adhesions will further damage the endometrium of the uterine cavity, reduce the volume of the uterus, affect the normal implantation of embryos, and easily lead to repeated miscarriages, premature births, and even infertility. This has become an urgent clinical problem in obstetrics and gynecology.

At present, in the clinical treatment of intrauterine adhesions, hysteroscopic separation of intrauterine adhesions is often used, and physical barriers such as intrauterine devices, balloon stents, Foley double-lumen catheters, and COOK silicone balloon stents are placed during the operation, or Inject drugs (hyaluronic acid, chitosan, estrogen and progesterone, polylactic acid gel), or a combination of drugs and stents. Its purpose is to release intrauterine adhesions, restore the normal anatomical shape of the uterine cavity, and promote endometrial regeneration and reproductive function. Although the existing methods have achieved a certain clinical effect, patients with moderate to severe intrauterine adhesions are prone to recurrence after surgery, and the rate of re-adhesion is as high as 62.5%, resulting in a postoperative pregnancy rate of only 22.5%-33.3%. Therefore, how to reduce the risk of hysteroscopy Re-adhesion has become the focus of clinical attention and a difficult problem.

Facing the clinical complications of intrauterine adhesions, through an in-depth analysis of the physical barrier devices placed after intrauterine adhesions, there are still many deficiencies, as follows:

1) IUD: The surface area of the conventional IUD is small, which makes the isolation ability limited, and it is difficult to maintain the separation of the walls of the uterine cavity, especially the middle and lower segments of the uterine cavity and the uterine horn; recurrence and re-adhesion will wrap the IUD, and the IUD will be deformed and taken out Difficult, high recurrence rate, aseptic inflammation is not conducive to endometrial healing, multiple placement and removal are easy to form new damage;

2) Foley balloon catheter: the spherical structure does not conform to the shape of the uterine cavity, and cannot fully isolate the wound, especially the high-recurrence peripheral adhesions; the spherical structure leads to obvious pressure on the local wound, which affects the subintimal blood supply and is not conducive to intimal regeneration ; The catheter is kept on both sides of the vagina, causing iatrogenic infection and patient discomfort, and increasing the duration of antibiotic use; it can only be kept for a short time, and keeping it for a long time will increase the risk of infection and affect the growth of the endometrium; the balloon pressure lacks quantification According to standards and standards, it is easy to fall off when the pressure is low, otherwise it will cause discomfort and affect the repair of the endometrium.

3) Uterine cavity-fitting balloon: placement is more complicated, and the cervix needs to be dilated; the catheter cannot drain intrauterine exudate, nor can it inject anti-adhesion drugs into the uterine cavity; the catheter remains in the vagina, and there is a risk of infection and patient discomfort; long-term retention will compress the wound, which is not conducive to the regeneration and repair of the intima. The balloon pressure is relatively uniform, but there is still a lack of quantitative basis and standards for balloon pressure.

In general, the existing physical barriers placed after intrauterine adhesions have the following problems: the existing physical barriers placed after intrauterine adhesions generally have implants that are difficult to fit well with the patient's uterine wall, so On the one hand, it is difficult to fully isolate the wound on the wall of the uterine cavity; on the other hand, the uniform pressure of the implant on the wall of the uterine cavity can easily cause insufficient blood supply to the endometrium in different areas of the wall of the uterine cavity, which is not conducive to the regeneration and repair of the endometrium. Therefore, it is difficult to reduce the possibility of recurrence of intrauterine adhesions in patients after surgery. In addition, it is difficult to promote endometrial regeneration and repair through combined drug supply when only relying on compression separation, and the efflux and leakage prevention of fluids such as exudate and adhesions in the uterine cavity.

Referring to Fig. 1, Fig. 1 is a schematic structural diagram of a degradable implant for preventing intrauterine adhesions according to an embodiment of the present invention;

An embodiment of the present invention provides a degradable implant for preventing intrauterine adhesions, the degradable implant is composed of a concave wrinkled elastic monomer, wherein the concave wrinkled elastic monomer is in the Circumferential and axial expansion and contraction deformation of the degradable implant; when the degradable implant is not stretched, the geometry of the degradable implant matches the contour of the patient's uterine cavity ; After the degradable implant is stretched, the geometric shape of the degradable implant is deformed into a cylindrical shape.

As shown in FIG. 1 , the degradable implant 1 is used to be placed in the uterine cavity 2 to prevent intrauterine adhesions in the uterine cavity 2 . The degradable implant 1 is composed of concave folded elastic monomer 3 . Since the concave pleated elastic monomer expands and shrinks in the circumferential and axial directions of the degradable implant, as shown in FIG. 2, FIG. Schematic illustration of tensile deformation of a biodegradable implant with lumen adhesions. After the degradable implant is stretched, the geometric shape of the degradable implant can be transformed into a cylindrical shape. After the rebound of the degradable implant, the geometric shape of the degradable implant returns to match the outline of the patient's uterine cavity. Therefore, before clinical implantation, the volume of the degradable implant can be reduced under the action of axial tensile force, and the shape of the degradable implant can be deformed into a cylindrical shape, and then the degradable implant can be placed in a specified position. After positioning, the axial stretching force is gradually reduced until the geometry of the degradable implant returns to an initial shape that matches the contour of the patient's uterine cavity when it is not stretched. When the axial tensile force pulls or releases the degradable implant, the deformation rate of the degradable implant is in the range of 0.5-5 mm/s, so as to avoid excessive pulling and releasing on the degradable implant. damage to the structure of the degradable implant described above.

Wherein, the cross-sectional shape, curvature and geometric size of the concave pleated elastic monomer can be adjusted according to the deformation response requirements of the degradable implant. Wherein the cross-sectional shape of the concave pleated elastic monomer can be at least one of rectangle, circle or other polygons (such as pentagon, hexagon, etc.) other than the rectangle, wherein the cross-sectional shape can be preferably Rectangular, so as to ensure that the degradable implant has a larger contact area with the inner membrane of the patient's uterine cavity, the curvature of the concave fold elastic monomer is preferably arc-shaped, and the concave fold elastic The thickness of the monomer is preferably 0.5 mm. The concave pleated elastic monomers are connected by arc-shaped connecting beams, so as to ensure the elastic deformation capability between the concave pleated elastic monomers.

Of course, it can be understood that, according to the elastic deformation requirements of different areas on the wall surface of the uterine cavity of the patient, each concave pleated elastic monomer on the degradable implant can adopt a structure of non-uniform thickness and geometric size. In addition, the overall deformation capacity of the degradable implant is greater than 30%, the deformation force of the degradable implant during the deformation process is lower than the yield strength of the material, and the safety factor is greater than 1.5, so as to prevent the degradable implant from Problems such as fracture and breakage of the implant occur during the deformation process.

Therefore, in this embodiment, the degradable implant is formed by using the concave pleated elastic monomer, because the concave pleated elastic monomer can expand and expand in the circumferential and axial directions of the degradable implant. Therefore, on the one hand, the degradable implant can fit well with the wall of the patient's uterine cavity; on the other hand, before the degradable implant is placed into the patient's uterine cavity, it can The degradable implant makes the geometric shape of the degradable implant deform into a cylindrical shape, so that the uterus does not need to be expanded when the degradable implant is placed, and the convenience of the implant placement operation is also improved. , can reduce or even avoid new injuries and pain during operation, and can effectively reduce the possibility of recurrence of postoperative intrauterine adhesions in patients. In addition, the implant used in the present invention is a degradable implant, so it can avoid multiple placements and removals to increase operational complexity and form new wounds, and improve the use safety of the degradable implant.

Wherein, the composition material of the degradable implant is a matrix material and a specified drug, wherein the matrix material is a composite material of a degradable polymer or a degradable polymer and a degradable bioceramic, and the matrix material The external surface or internal loading of the designated drug.

It should be noted that, in order to reduce the occurrence of infectious inflammation of the endometrium of the patient's uterine cavity, promote the regeneration and repair of the endometrium of the uterine cavity, thereby further reducing the probability of intrauterine adhesions. In addition to the base material used to isolate the wound surface of the wall of the uterine cavity, the constituent materials of the degradable implant also include specified drugs used for antibacterial and/or growth promotion. Wherein, the matrix material is a degradable polymer or a composite material of the degradable polymer and degradable bioceramics. The degradable polymer includes, but is not limited to, a mixture of one or more of polylactic acid, polycaprolactone, and polylactic-co-glycolic acid copolymer, and can also be other degradable polymers that are harmless to the patient's body. The degradable bioceramic includes but is not limited to calcium silicate, calcium phosphate and a mixture of one or more of bioglass, and may also include other degradable bioceramic materials that are harmless to the patient's body.

Compared with the degradable polymer, the composite material of the degradable polymer and the degradable bioceramic has better physical properties, such as stiffness, yield strength and the like. As for the loading method of the specified drug, the specified drug can be loaded on the outer surface or inside of the matrix material. Exemplarily, the specified drug can be loaded on the surface of the base material by using the specified drug as a coating. The matrix material with a porous structure can also be used, so that the prescribed drug can be injected into the interior of the matrix material, so that the prescribed drug can be released through the pores of the matrix material.

Wherein, the degradable polymer is at least one of polylactic acid, polycaprolactone and polylactic-co-glycolic acid copolymer; the degradable bioceramic is at least one of calcium silicate, calcium phosphate and bioglass ; The mass fraction range of degradable bioceramics in the composite material is 0-50wt%.

It can be understood that the degradable polymer is a mixture of one or more of polylactic acid, polycaprolactone and polylactic-co-glycolic acid copolymer, and the degradable bioceramic is calcium silicate, calcium phosphate and biological A mixture of one or more types in glass. Wherein, the mass fraction range of the degradable bioceramic in the composite material is 0-50wt%. In this embodiment, the proportion of the mass fraction of the degradable bioceramic in the composite material is controlled below 50wt%, so as to avoid the high proportion of the degradable bioceramic in the composite material and affect the degradable bioceramic. The elastic deformation capacity of the body.

Wherein, the specified drug includes at least one of estrogen, antibacterial drugs and growth factors.

Among them, estrogen can promote the rapid growth and recovery of the endometrium, maintain the integrity of the endometrium, reduce the exposure caused by damage to the basal layer of the endometrium, and protect the muscular tissue; at the same time, it can change the properties of cervical mucus, making cervical mucus less and more viscous. Thick, can prevent bacteria from ascending and prevent pelvic infection. Antibacterial drugs such as gentamicin, penicillin and streptomycin can effectively prevent infection while avoiding the side effects of systemic medication and reducing the occurrence of endometrial infectious inflammation. The growth factor is a cell growth factor that can promote the regeneration of the endometrium, such as EGF (Epidermal Growth Factor, epidermal growth factor), which can promote the regeneration and repair of the endometrium of the uterine cavity. Wherein, the drug loading amount of the specified drug is selected according to the size specification of the degradable implant, the degradation cycle and the detection index level of the patient's body, and the general drug loading amount is 0.05-5 mg. One or more of estrogen, antibacterial drugs, and growth factors can be used as the specified drug to reduce the occurrence of infectious inflammation of the endometrium of the patient's uterine cavity and promote the regeneration and repair of the endometrium of the uterine cavity , thereby further reducing the chance of intrauterine adhesions.

Wherein, the end of the degradable implant close to the bottom of the uterine cavity is provided with a stretch retaining ring for preventing fluid leakage.

During the regeneration and repair of the inner lining of the patient's uterine cavity, interstitial fluid usually leaks out. Therefore, in this embodiment, the end of the degradable implant close to the bottom of the uterine cavity is provided with a stretched retaining ring, so as to prevent the leakage of fluid accumulation and avoid affecting the normal life of the patient.

Further, the stretch retaining ring is provided with an external interface for connecting with a drainage device to drain the effusion.

In order to prevent excessive effusion from causing reinfection of the patient's uterine cavity and affecting regeneration and repair of the endometrium, the stretch retaining ring is provided with an external interface for connecting a drainage device to drain the effusion. Therefore, the fluid in the uterine cavity can be drained after the external interface is connected to the drainage device.

Wherein, the initial degradation rate of the degradable implant is lower than 0.15mm/y, the medium-term degradation rate is 0.15-0.4mm/y, and the long-term degradation rate is greater than 0.4mm/y, until the degradable implant is completely degradation.

It should be noted that the degradation rate of the degradable implant can be regulated in stages according to the degree of intrauterine adhesion and clinical needs of the patient. In the initial period, the degradable implant mainly plays a role of physical isolation, therefore, the initial degradation rate of the degradable implant should be lower than 0.15mm/y. In the mid-term period, in order to promote endometrial regeneration, the mid-term degradation rate of the degradable implant is controlled at 0.15-0.4mm/y. The long-term degradation rate of the degradable implant should be greater than 0.4 mm/y until the degradable implant is completely degraded. Usually, the degradable implant is stored in the patient's body for 1-6 months, and the degradation products of the degradable implant have no side effects on the patient's body and can effectively promote intimal regeneration and inhibit related inflammation.

Referring to Fig. 3, Fig. 3 is a schematic flowchart of the first embodiment of the preparation method of the degradable implant for preventing intrauterine adhesions of the present invention.

An embodiment of the present invention provides a method for preparing a degradable implant for preventing intrauterine adhesions, the preparation method comprising:

Step S100, obtaining the patient's uterine cavity information;

Step S200, generating a corresponding implant model according to the uterine cavity information;

Step S300, preparing a degradable implant corresponding to the implant model through additive manufacturing, wherein the degradable implant is composed of a concave wrinkled elastic monomer, and the concave wrinkled elastic monomer is Circumferential and axial expansion and contraction deformation of the degradable implant; when the degradable implant is not stretched, the geometric shape of the degradable implant is consistent with the contour of the patient's uterine cavity matching; after the degradable implant is stretched, the geometric shape of the degradable implant is deformed into a cylindrical shape.

Specifically, the patient is a patient who needs to be placed with a degradable implant for preventing intrauterine adhesions. The uterine cavity information includes at least the three-dimensional structure of the patient's uterine cavity and the adhesion-dissociation area of the patient's uterine cavity (that is, the area that needs to be separated in the uterine cavity to avoid adhesions). Exemplarily, according to the CT data of the patient's uterine cavity scan, Mimics software is used to reconstruct the three-dimensional model of the uterine cavity to determine the three-dimensional structure of the patient's uterine cavity. The adhesion and separation area was judged by the results of B-ultrasound examination. According to the uterine cavity information, the target placement area of the degradable implant and the curved surface of the uterine cavity endometrium to be covered can be determined, so that a corresponding implant model can be generated. There are certain differences in the three-dimensional structure of the uterine cavity and the adhesion separation area in different patients. The degradable implant corresponding to the implant model is prepared by additive manufacturing, which can ensure the accuracy of the prepared degradable implant, so that the degradable implant can fit well in the patient's uterus. on the cavity wall.

Also, the degradable implant is composed of a concave wrinkled elastic monomer, and the concave wrinkled elastic monomer expands and shrinks in the circumferential and axial directions of the degradable implant; When the degradable implant is not stretched, the geometric shape of the degradable implant matches the contour of the patient's uterine cavity; after the degradable implant is stretched, the degradable implant The geometric shape of the object is deformed into a cylindrical shape. Therefore, before the degradable implant is placed into the patient's uterine cavity, the geometric shape of the degradable implant can be deformed into a cylindrical shape by stretching the degradable implant, so that The aforementioned biodegradable implants do not require uterine dilatation, and also improve the convenience of implant placement operations, which can reduce or even avoid new damage and pain during operation. In summary, it can effectively reduce postoperative intrauterine adhesions in patients. possibility of recurrence. In addition, the implant used in the present invention is a degradable implant, so it can avoid multiple placements and removals to increase operational complexity and form new wounds, and improve the use safety of the degradable implant.

Wherein, step S200 generates a corresponding implant model according to the uterine cavity information, including:

Step S210, according to the information of the uterine cavity, determine the curved surface of the endometrium to be covered, and use the curved surface of the endometrial surface of the uterine cavity to expand outward in the direction of the submembranous normal line within a first preset distance as the patient's contour boundary. The outline of the uterine cavity;

Step S220, according to the outline of the uterine cavity, an implant model corresponding to the outline of the patient's uterine cavity is generated.

After obtaining the information of the patient's uterine cavity, the surface of the endometrium to be covered can be determined according to the three-dimensional structure of the patient's uterine cavity and the adhesion and separation area of the patient's uterine cavity, and of course the target placement area of the degradable implant can also be included. In order to further ensure that the degradable implant can be stably attached to the inner wall of the patient's uterine cavity, the curved endometrium of the uterine cavity is used to face the submembrane normal direction (that is, the endometrial functional layer of the uterine cavity points to the direction of the basal layer) Outwardly expanding the contour boundary within the first preset distance range as the contour of the patient's uterine cavity. Wherein the first preset distance range is 0.1-2.5mm. The area of the uterine cavity covered by the degradable implant can reach 15-50%, and the expansion distance of the end of the degradable implant near the bottom of the uterine cavity is smaller than that of the end near the top of the uterine cavity. Therefore, according to the contour of the uterine cavity, an implant model corresponding to the contour of the uterine cavity of the patient is generated.

In this embodiment, the curved surface of the endometrium to be covered is determined according to the information of the uterine cavity, and the contour boundary within the first preset distance range is expanded outward in the direction of the normal line of the submembrane with the curved surface of the endometrial cavity As the patient's uterine cavity contour, an implant model corresponding to the patient's uterine cavity contour is generated according to the uterine cavity contour. Therefore, there is a difference in the first preset distance range between the contour of the implant model and the curved surface of the endometrium to be covered, so that the degradable implant prepared based on the implant model is stably fixed on the In the patient's uterine cavity.

It should be noted that in this article, relational terms such as first and second etc. are only used to distinguish one entity/operation/object from another entity/operation/object and do not necessarily require or imply these the existence of any such actual relationship or order between entities/operations/objects; the term "comprises", "comprises" or any other variation thereof is intended to cover a non-exclusive inclusion such that a process, method, An article or system includes not only those elements, but also other elements not expressly listed, or elements inherent in such a process, method, article, or system. Without further limitations, an element defined by the phrase "comprising a..." does not preclude the presence of additional identical elements in the process, method, article or system comprising that element.

The serial numbers of the above embodiments of the present invention are for description only, and do not represent the advantages and disadvantages of the embodiments.

The above are only preferred embodiments of the present invention, and are not intended to limit the patent scope of the present invention. Any equivalent structure or equivalent process conversion made by using the description of the present invention and the contents of the accompanying drawings, or directly or indirectly used in other related technical fields , are all included in the scope of patent protection of the present invention in the same way.

Claims (10)

1. A degradable implant for preventing intrauterine adhesions, characterized in that, the degradable implant is composed of concave folded elastic monomers, wherein the concave folded elastic monomers circumferential and axial expansion and contraction deformation of the degradable implant; when the degradable implant is not stretched, the geometry of the degradable implant matches the contour of the patient's uterine cavity, Wherein the implant model corresponding to the degradable implant is generated according to the uterine cavity information of the patient; after the degradable implant is stretched, the geometric shape of the degradable implant is transformed into a cylindrical shape. 2. The degradable implant for preventing intrauterine adhesions as claimed in claim 1, wherein the composition material of the degradable implant is a matrix material and a prescribed drug, wherein the matrix material is a degradable polymer or the composite material of the degradable polymer and the degradable bioceramic, and the outer surface or the inner part of the matrix material is loaded with a specified drug. 3. the anti-uterine adhesion degradable implant as claimed in claim 2, is characterized in that, described degradable polymer is at least one in polylactic acid, polycaprolactone and polylactic-co-glycolic acid copolymer The degradable bioceramic is at least one of calcium silicate, calcium phosphate and bioglass; the mass fraction of the degradable bioceramic in the composite material ranges from 0-50wt%. 4 . The degradable implant for preventing intrauterine adhesions according to claim 2 , wherein the designated drug includes at least one of estrogen, antibacterial drugs and growth factors. 5. The degradable implant for preventing intrauterine adhesions according to claim 1, characterized in that, each of the concave folded elastic monomers is connected by an arc-shaped connecting beam. 6. The degradable implant for preventing intrauterine adhesions according to claim 1, characterized in that, the end of the degradable implant near the bottom of the uterine cavity is provided with a stretch retaining ring for preventing fluid leakage . 7. The degradable implant for preventing intrauterine adhesions according to claim 6, characterized in that, the stretch retaining ring is provided with an external interface for connecting with a drainage device to drain the effusion. 8. The degradable implant for preventing intrauterine adhesions as claimed in claim 1, wherein the initial degradation rate of the degradable implant is lower than 0.15mm/y, and the mid-term degradation rate is 0.15-0.4mm /y, the long-term degradation rate is greater than 0.4mm/y, until the degradable implant is completely degraded. 9. A preparation method of a degradable implant for preventing intrauterine adhesions, characterized in that the preparation method comprises: Obtain the patient's uterine cavity information; Generate a corresponding implant model according to the uterine cavity information; The degradable implant corresponding to the implant model is prepared by additive manufacturing, wherein the degradable implant is composed of a concave wrinkled elastic monomer, and the concave wrinkled elastic monomer is placed on the desirable circumferential and axial expansion and contraction deformation of the degradable implant; when the degradable implant is not stretched, the geometry of the degradable implant matches the contour of the patient's uterine cavity; After the degradable implant is stretched, the geometric shape of the degradable implant deforms into a cylindrical shape. 10. The method for preparing a degradable implant for preventing intrauterine adhesions as claimed in claim 9, wherein the step of generating a corresponding implant model according to the intrauterine cavity information includes: According to the information of the uterine cavity, determine the curved surface of the endometrium of the uterine cavity to be covered, and use the curved surface of the endometrium of the uterine cavity to expand outward in the direction of the submembrane normal to the contour boundary within the first preset distance range as the patient's uterine cavity. Cavity profile; According to the outline of the uterine cavity, an implant model corresponding to the outline of the patient's uterine cavity is generated.

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