CN115590654A - Degradable implant for preventing intrauterine adhesion and preparation method thereof - Google Patents
Degradable implant for preventing intrauterine adhesion and preparation method thereof Download PDFInfo
- Publication number
- CN115590654A CN115590654A CN202211504616.3A CN202211504616A CN115590654A CN 115590654 A CN115590654 A CN 115590654A CN 202211504616 A CN202211504616 A CN 202211504616A CN 115590654 A CN115590654 A CN 115590654A
- Authority
- CN
- China
- Prior art keywords
- degradable
- implant
- degradable implant
- uterine cavity
- patient
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y10/00—Processes of additive manufacturing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B33—ADDITIVE MANUFACTURING TECHNOLOGY
- B33Y—ADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
- B33Y80/00—Products made by additive manufacturing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
- A61F2002/0081—Special surfaces of prostheses, e.g. for improving ingrowth directly machined on the prosthetic surface, e.g. holes, grooves
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 concave-type folded elastic single bodies, wherein the concave-type folded elastic single bodies are expanded and contracted in the circumferential direction and the axial direction of the degradable implant; when the degradable implant is not stretched, the geometric shape of the degradable implant is matched with the outline of the uterine cavity of a patient; after the degradable implant is stretched, the outer geometric shape of the degradable implant is deformed into a cylinder shape. According to the invention, the degradable implant is formed by the concave type folded elastic monomer, so that the degradable implant can be well attached to the wall surface of the uterine cavity, and the convenience of the placement operation of the degradable implant is improved, thereby effectively reducing the possibility of recurrence of postoperative intrauterine adhesion of a patient.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a degradable implant for preventing intrauterine adhesion and a preparation method thereof.
Background
Because clinical uterine cavity operations such as artificial abortion, intrauterine adhesion separation, hysteromyoma, mediastinum, endometrial polypectomy, uterine malformation plastic surgery and the like are gradually increased, factors such as uterine cavity operation or secondary infection and the like easily cause irreversible damage to an endometrial substrate, and pathological symptoms of local or complete mutual adhesion are caused to the uterine cavity wall. Meanwhile, the intrauterine adhesion further damages the endometrium of the uterine cavity, reduces the uterine volume, influences the normal implantation of the embryo, easily causes repeated abortion, premature delivery and even infertility, and becomes a clinical problem which needs to be solved urgently in obstetrics and gynecology.
Currently, hysteroscopic intrauterine adhesion separation is usually adopted for clinical treatment of intrauterine adhesion, and physical barrier barriers such as an intrauterine device, a balloon stent, a Foley double-lumen catheter, a COOK silica gel balloon stent and the like are placed in the operation, or medicines (hyaluronic acid, chitosan, estrogen, polylactic acid gel) are injected, or medicines and the stent are combined. The purpose is to relieve the adhesion of uterine cavity, recover the normal anatomical form of uterine cavity and promote the regeneration and repair of endometrium and reproductive function. Although the existing method achieves certain clinical curative effect, the moderate and severe intrauterine adhesion patients are easy to relapse after operation, the rate of re-adhesion is as high as 62.5%, so that the pregnancy rate after operation is only 22.5% -33.3%, and therefore, how to reduce the re-adhesion after the hysteroscope operation becomes a focus of clinical attention and a problem of thoroughness.
The physical barrier that current intrauterine adhesion postoperative was placed generally has the implant to be difficult to with the fine laminating of patient's palace chamber wall, consequently is difficult to fully keep apart the surface of a wound of palace chamber wall on the one hand, and on the other hand is that the implant also causes the blood supply under the membrane in the different regions of palace chamber wall easily to the even pressure of palace chamber wall not enough, is unfavorable for regeneration and the restoration of inner membrane, is difficult to reduce the possibility that patient's postoperative intrauterine adhesion recured from this.
Disclosure of Invention
The invention mainly aims to provide a preparation method of a degradable implant for preventing intrauterine adhesion, and aims to solve the technical problem that a physical barrier placed after an existing intrauterine adhesion operation is difficult to reduce the recurrence possibility of intrauterine adhesion of a patient after the operation.
In order to achieve the above object, the present invention provides a degradable implant for preventing intrauterine adhesion, which is composed of concave-type folded elastic single bodies, wherein the concave-type folded elastic single bodies are expanded and contracted in the circumferential direction and the axial direction of the degradable implant; when the degradable implant is not stretched, the geometric shape of the degradable implant is matched with the outline of the uterine cavity of a patient; after the degradable implant is stretched, the outer geometric shape of the degradable implant is deformed into a cylinder shape.
Optionally, the degradable implant is composed of 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, and the specified drug is loaded on the outer surface or inside of the matrix material.
Optionally, the degradable polymer is at least one of polylactic acid, polycaprolactone and polylactic-co-glycolic acid; the degradable biological ceramic is at least one of calcium silicate, calcium phosphate and biological glass; the mass fraction range of the degradable biological ceramics in the composite material is 0-50wt%.
Optionally, the specified medication includes at least one of an estrogen, an antibacterial drug, and a growth factor.
Optionally, the concave-type folded elastic single bodies are connected through arc-shaped connecting beams.
Optionally, one end of the degradable implant close to the bottom of the uterine cavity is provided with a tensile check ring for preventing effusion from leaking outwards.
Optionally, an external connector is arranged on the stretching retainer ring and used for connecting a drainage device to lead out the accumulated liquid.
Optionally, the degradable implant has an initial degradation rate of less than 0.15mm/y, a medium degradation rate of 0.15-0.4mm/y, and a long degradation rate of greater than 0.4mm/y until the degradable implant 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 adhesion, the preparation method comprising:
obtaining uterine cavity information of a patient;
generating a corresponding implant model according to the uterine cavity information;
preparing a degradable implant corresponding to the implant model through additive manufacturing, wherein the degradable implant is composed of concave-type folded elastic single bodies which expand and contract in the circumferential direction and the axial direction of the degradable implant; when the degradable implant is not stretched, the geometric shape of the degradable implant is matched with the outline of the uterine cavity of a patient; after the degradable implant is stretched, the outer geometric shape of the degradable implant is deformed into a cylindrical shape.
Optionally, the step of generating a corresponding implant model according to the uterine cavity information includes:
determining an inner membrane curved surface of the uterine cavity to be covered according to the uterine cavity information, and taking a contour boundary of the inner membrane curved surface of the uterine cavity, which is expanded outwards in a first preset distance range towards a lower membrane normal direction, as an external contour of the uterine cavity of the patient;
and generating an implant model corresponding to the outline of the uterine cavity of the patient according to the outline of the uterine cavity.
The degradable implant is composed of concave type folded elastic single bodies, wherein the concave type folded elastic single bodies expand and contract in the circumferential direction and the axial direction of the degradable implant. Thereby, the geometric shape of the degradable implant is matched with the outline of the uterine cavity of the patient when the degradable implant is not stretched based on the concave folded elastic monomer; after the degradable implant is stretched, the outer geometric shape of the degradable implant is deformed into a cylindrical shape. Therefore, the degradable implant is formed by the concave type folded elastic monomer, so that the degradable implant can be well attached to the uterine cavity wall surface of a patient, the convenience of the placement operation of the degradable implant is improved, and the possibility of recurrence of postoperative intrauterine adhesion of the patient can be effectively reduced. In addition, the implant adopted by the invention is a degradable implant, so that the increase of operation complexity and the formation of new wounds caused by repeated placement and removal can be avoided, and the use safety of the degradable implant is improved.
Drawings
FIG. 1 is a schematic structural diagram of a degradable implant for preventing intrauterine adhesion according to an embodiment of the present invention;
FIG. 2 is a schematic drawing showing the tensile deformation of a degradable implant for preventing intrauterine adhesion according to an embodiment of the present invention;
fig. 3 is a schematic flow chart of a first embodiment of the preparation method of the degradable implant for preventing intrauterine adhesion of the invention.
The implementation, functional features and advantages of the objectives of the present application will be further explained with reference to the accompanying drawings. These drawings and written description are not intended to limit the scope of the inventive concepts in any manner, but rather to illustrate the inventive concepts to those skilled in the art by reference to specific embodiments.
Detailed Description
It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, not all, embodiments of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The term "and/or" herein is merely an association describing an associated object, meaning that three relationships may exist, e.g., a and/or B, may mean: a exists alone, A and B exist simultaneously, and B exists alone.
The terms "first" and "second," and the like in the description and in the claims of embodiments of the present invention, are used for distinguishing between different objects and not for describing a particular order of the objects. For example, the first target object and the second target object, etc. are specific sequences for distinguishing different target objects, rather than describing target objects.
In the embodiments of the present invention, words such as "exemplary" or "for example" are used to mean serving as examples, illustrations or descriptions. Any embodiment or design described as "exemplary" or "e.g.," an embodiment of the present invention is not necessarily to be construed as preferred or advantageous over other embodiments or designs. Rather, use of the word "exemplary" or "such as" is intended to present concepts related in a concrete fashion.
In the description of the embodiments of the present invention, the meaning of "a plurality" means two or more unless otherwise specified. For example, a plurality of processing units refers to two or more processing units; a plurality of systems refers to two or more systems.
For clarity and conciseness of the description of the following embodiments, a brief introduction of the existing physical barrier placed after intrauterine adhesion is first given:
because clinical uterine cavity operations such as artificial abortion, intrauterine adhesion separation, hysteromyoma, mediastinum, endometrial polypectomy, uterine malformation plastic surgery and the like are gradually increased, factors such as uterine cavity operation or secondary infection and the like easily cause irreversible damage to the endometrial substrate, and the pathological symptoms of partial or total mutual adhesion of uterine cavity walls are caused. Meanwhile, the intrauterine adhesion further damages the endometrium of the uterine cavity, reduces the uterine volume, influences the normal implantation of the embryo, easily causes repeated abortion, premature delivery and even infertility, and becomes a clinical problem which needs to be solved urgently in obstetrics and gynecology.
Currently, hysteroscopic intrauterine adhesion separation is usually adopted for clinical treatment of intrauterine adhesion, and physical barrier barriers such as an intrauterine device, a balloon stent, a Foley double-lumen catheter, a COOK silica gel balloon stent and the like are placed in the operation, or medicines (hyaluronic acid, chitosan, estrogen, polylactic acid gel) are injected, or medicines and the stent are combined. The purpose is to relieve the adhesion of uterine cavity, recover the normal anatomical form of uterine cavity and promote the regeneration and repair of endometrium and reproductive function. Although the existing method achieves certain clinical curative effect, the moderate and severe intrauterine adhesion patients are easy to relapse after operation, the rate of re-adhesion is as high as 62.5%, so that the pregnancy rate after operation is only 22.5% -33.3%, and therefore, how to reduce the re-adhesion after the hysteroscope operation becomes a focus of clinical attention and a problem of thoroughness.
In view of the clinical complications of intrauterine adhesions, there are still a number of disadvantages by deep analysis of physical barriers placed after intrauterine adhesions, as follows:
1) Intrauterine device: the surface area of the conventional intrauterine device is small, so that the isolation capability is limited, and the separation of all walls of the uterine cavity is difficult to maintain, particularly the middle-lower segment and the uterine horn of the uterine cavity; the intrauterine device is wrapped by the recurrent re-adhesion, the intrauterine device is difficult to take out due to deformation, the recurrence rate is high, aseptic inflammation is not beneficial to healing of endometrium, and new injury is easy to form after the intrauterine device is placed and taken out for many times;
2) Foley balloon catheter: the spherical structure is not in accordance with the shape of the uterine cavity, the wound surface cannot be fully isolated, and particularly the peripheral type adhesion with high recurrence rate; the spherical structure causes obvious pressure on local wound surface, influences blood supply under intima, and is not beneficial to intimal regeneration; the catheter is kept in the inner side/the outer side of the vagina, iatrogenic infection and discomfort of patients are caused, and the use time of antibiotics is prolonged; only can be reserved for a short time, and the long-time reservation has the risks of increasing infection and influencing the growth of intima; the lack of quantitative basis and standard of balloon pressure can cause the balloon to easily fall off when the pressure is small, and otherwise, discomfort and influence on intimal repair can be caused.
3) Uterine cavity conformable balloon: the placement is complicated and the cervix needs to be dilated; the catheter can not drain the effusion in the uterine cavity and can not inject anti-adhesion medicines into the uterine cavity; the catheter remains in the vagina, with the risk of infection and patient discomfort; the long-term retention can press the wound surface, which is not beneficial to regeneration and repair of the intima. The balloon pressure is relatively uniform, but the balloon pressure still lacks quantification and standardization.
Generally, the problems that exist in the physical barrier that is placed after the existing intrauterine adhesion operation are: the physical separation barrier that current palace chamber adhesion postoperative was placed generally has the implant to be difficult to with the fine laminating of patient's palace chamber wall, consequently is difficult to fully keep apart the surface of a wound of palace chamber wall on the one hand, and on the other hand then the implant also causes the blood supply of membrane under in the different regions of palace chamber wall easily to the even pressure of palace chamber wall not enough, is unfavorable for regeneration and the restoration of inner membrance, is difficult to reduce the possibility that patient's postoperative palace chamber adhesion recurs from this. In addition, the problems of difficult promotion of regeneration and repair of the intima through the supply of the combined medicament and the discharge and leakage prevention of effusion such as effusion, adhesion liquid and the like in the uterine cavity are also solved when the uterine cavity is separated by simply depending on compression.
Referring to fig. 1, fig. 1 is a schematic structural view of a degradable implant for preventing intrauterine adhesion according to an embodiment of the present invention;
one embodiment of the invention provides a degradable implant for preventing intrauterine adhesion, which is composed of concave-type folded elastic single bodies, wherein the concave-type folded elastic single bodies expand and contract in the circumferential direction and the axial direction of the degradable implant; when the degradable implant is not stretched, the geometric shape of the degradable implant is matched with the outline of the uterine cavity of a patient; after the degradable implant is stretched, the outer geometric shape of the degradable implant is deformed into a cylindrical shape.
As shown in figure 1, the degradable implant 1 is used for being placed in a uterine cavity 2 and preventing the uterine cavity 2 from generating intrauterine adhesion. The degradable implant 1 is composed of concave-type folded elastic single bodies 3. Since the concave-type folded elastic single body expands and contracts in the circumferential direction and the axial direction of the degradable implant, as shown in fig. 2, fig. 1 is a schematic drawing of the tensile deformation of the degradable implant for preventing intrauterine adhesion according to the embodiment of the present invention. After the degradable implant is stretched, the geometry of the degradable implant can then be deformed into a cylindrical shape. After the degradable implant rebounds, the geometric shape of the degradable implant returns to match the contour of the uterine cavity of the patient. Therefore, before clinical implantation, the volume of the degradable implant can be reduced under the action of axial tensile force, the shape of the degradable implant is deformed to be similar to a cylindrical shape, and then the axial tensile force is gradually reduced after the degradable implant is placed at a specified position until the geometric shape of the degradable implant is restored to the initial shape matched with the outline of the uterine cavity of a patient when the geometric shape of the degradable implant is not stretched. The rate of deformation of the degradable implant is in the range of 0.5-5mm/s when the degradable implant is pulled or released by an axial tensile force so as not to damage the structure of the degradable implant by too fast pulling and releasing.
Wherein, the cross-sectional shape, curvature and geometric dimension of the concave-fold elastic monomer can be adjusted and controlled according to the deformation response requirement of the degradable implant. Wherein the cross-sectional shape of the inwardly concave folded elastic single body may be at least one of a rectangle, a circle or other polygons (such as pentagon, hexagon, etc.) except the rectangle, wherein the cross-sectional shape may be preferably a rectangle, so as to ensure that the degradable implant has a larger contact area with the inner membrane of the uterine cavity of the patient, the curvature of the inwardly concave folded elastic single body is preferably a circular arc, and the thickness of the inwardly concave folded elastic single body is preferably 0.5mm. The concave fold elastic single bodies are connected through arc-shaped connecting beams, so that the elastic deformation capacity of the concave fold elastic single bodies is ensured.
It is understood that, according to the elastic deformation requirements of different areas on the uterine cavity wall of the patient, the concave folded elastic single bodies on the degradable implant can adopt non-uniform thickness and geometric dimension structures. In addition, the whole deformability of the degradable implant is more than 30%, the deformation stress of the degradable implant in the deformation process is lower than the yield strength of the material, and the safety factor is more than 1.5, so that the problems of breakage, breakage and the like of the degradable implant in the deformation process are avoided.
Therefore, the embodiment forms the degradable implant by adopting the concave-type folded elastic single body, and the concave-type folded elastic single body can expand and contract in the circumferential direction and the axial direction of the degradable implant, so that on one hand, the degradable implant can be well attached to the wall surface of the uterine cavity of a patient, on the other hand, before the degradable implant is placed in the uterine cavity of the patient, the degradable implant can be stretched to enable the geometric outer deformation of the degradable implant to form a cylinder shape, so that the degradable implant is placed without expanding the uterus, the convenience of placing operation of the implant is improved, new damage and pain caused by operation can be reduced or even avoided, and the possibility of recurrence of postoperative intrauterine adhesion of the patient can be effectively reduced. In addition, the implant adopted by the invention is a degradable implant, so that the increase of operation complexity and the formation of new wounds caused by repeated placement and removal can be avoided, and the use safety of the degradable implant is improved.
The degradable implant is prepared from 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, and the specified drug is loaded on the outer surface or inside of the matrix material.
It should be noted that, in order to reduce the occurrence of intimal infectious inflammation in the uterine cavity of the patient, the regeneration and repair of the intima of the uterine cavity are promoted, thereby further reducing the occurrence of intrauterine adhesion. The degradable implant is made of a matrix material for isolating the wound surface on the wall surface of the uterine cavity, and also comprises a specified medicament for resisting bacteria and/or promoting growth. Wherein the matrix material is a degradable polymer or a composite material of the degradable polymer and degradable biological ceramics. The degradable polymer comprises but is not limited to one or a mixture of polylactic acid, polycaprolactone and polylactic-co-glycolic acid, and can also be other degradable polymers harmless to the body of a patient. The degradable biological ceramic comprises but is not limited to a mixture of one or more of calcium silicate, calcium phosphate and bioglass, and can also comprise other degradable biological ceramic materials harmless to the body of a patient.
Compared with degradable polymers, the degradable polymer and degradable biological ceramic composite material has better physical properties such as rigidity, yield strength and the like. For the loading mode of the specified drug, the specified drug can be loaded on the outer surface or the inner part of the matrix material. Illustratively, the specified drug may be loaded by applying the specified drug as a coating on the surface of the base material. The matrix material may also be of a porous structure so that the specified drug can be injected into the interior of the matrix material so that the specified 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; the degradable biological ceramic is at least one of calcium silicate, calcium phosphate and biological glass; the mass fraction of the degradable biological ceramic in the composite material is 0-50wt%.
It is understood that the degradable polymer is a mixture of one or more of polylactic acid, polycaprolactone and polylactic-co-glycolic acid, and the degradable bioceramic is a mixture of one or more of calcium silicate, calcium phosphate and bioglass. Wherein the mass fraction of the degradable biological ceramic in the composite material is 0-50wt%. The embodiment controls the mass fraction of the degradable bioceramic in the composite material to be less than 50wt% so as to avoid that the mass fraction of the degradable bioceramic in the composite material is too high to influence the elastic deformability of the degradable implant.
Wherein the specified drug comprises at least one of estrogen, antibacterial drugs and growth factors.
The estrogen can promote the rapid growth and recovery of the intima, maintain the integrity of the intima, reduce the uncovering caused by the damage of the intima basal layer and protect the muscular layer tissue; meanwhile, the property of cervical mucus can be changed, the cervical mucus is reduced and sticky, bacteria can be prevented from ascending, and pelvic infection is prevented. Antibacterial drugs such as gentamicin, penicillin and streptomycin can effectively prevent infection, avoid toxic and side effects of systemic administration, and reduce occurrence of endometrium infectious inflammation. The Growth Factor is a cell Growth Factor required for promoting regeneration of the inner membrane, such as EGF (Epidermal Growth Factor), and can promote regeneration and repair of the inner membrane of the uterine cavity. Wherein the drug loading of the specified drug is selected according to the size specification and degradation period of the degradable implant and the detection index level of the body of a patient, and the drug loading is generally 0.05-5mg. One or more of estrogen, antibacterial drugs and growth factors can be used as the specified drugs to reduce the occurrence of intimal infectious inflammation of the uterine cavity of a patient and promote the regeneration and repair of the intima of the uterine cavity, thereby further reducing the probability of occurrence of intrauterine adhesion.
Wherein, the degradable implant is provided with a tensile retaining ring near one end of the bottom of the uterine cavity for preventing the effusion from leaking.
Tissue fluid is often exuded due to the intima of the patient's uterine cavity during regeneration and repair. Therefore, in the embodiment, one end of the degradable implant, which is close to the bottom of the uterine cavity, is provided with the stretching retainer ring, so that effusion is prevented from leaking outwards, and the normal life of a patient is prevented from being influenced.
Furthermore, an external connector is arranged on the stretching retainer ring and is used for connecting a drainage device to lead out the accumulated liquid.
In order to prevent the situation that the effusion is too much, the uterine cavity of the patient is infected again and the regeneration and the repair of the inner membrane are influenced, an external interface is arranged on the stretching retainer ring and is used for connecting a drainage device to lead out the effusion. Therefore, the effusion in the uterine cavity is led out after the external interface is connected with the drainage device.
Wherein the initial degradation rate of the degradable implant is lower than 0.15mm/y, the middle 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 degraded.
It should be noted that the degradation rate of the degradable implant can be regulated according to the degree of intrauterine adhesion and clinical requirements of patients. The degradable implant primarily serves as a physical barrier during the initial period of time, and therefore, the initial degradation rate of the degradable implant should be less than 0.15mm/y. In the middle period, in order to promote the regeneration of endometrium, the middle degradation rate of the degradable implant is controlled to be 0.15-0.4mm/y, and in the long period (namely after the separation of endometrium and the regeneration effect are remarkably checked clinically), the long degradation rate of the degradable implant is more than 0.4mm/y until the degradable implant is completely degraded. Usually, the degradable implant is stored in the body of a patient for 1-6 months, and the degradation products of the degradable implant have no side effect on the body of the patient and can effectively promote the regeneration of intima and the inhibition of related inflammation.
Referring to fig. 3, fig. 3 is a schematic flow chart of a first embodiment of the preparation method of the degradable implant for preventing intrauterine adhesion of the present invention.
The preparation method of the degradable implant for preventing intrauterine adhesion provided by the embodiment of the invention comprises the following steps:
step S100, obtaining uterine cavity information of a patient;
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 concave-type folded elastic single bodies which expand and contract in the circumferential direction and the axial direction of the degradable implant; when the degradable implant is not stretched, the geometric shape of the degradable implant is matched with the outline of the uterine cavity of a patient; after the degradable implant is stretched, the outer geometric shape of the degradable implant is deformed into a cylindrical shape.
In particular, the patient is a patient who needs to be implanted with a degradable implant for preventing intrauterine adhesion. The uterine cavity information at least comprises a three-dimensional structure of the uterine cavity of the patient and an adhesion separation zone of the uterine cavity of the patient (namely, a zone which needs to be separated in the uterine cavity to avoid adhesion). Illustratively, according to CT data scanned by the uterine cavity of the patient, mimics software is adopted to reconstruct a three-dimensional model of the uterine cavity, and the three-dimensional structure of the uterine cavity of the patient is determined. And judging the adhesion separation area through the B-ultrasonic examination result. According to the uterine cavity information, a target placement area of the degradable implant and an endometrium curved surface to be covered can be determined, so that a corresponding implant model can be generated. Because the three-dimensional structures of the uterine cavities of different patients and the adhesion separation area have certain differences. The degradable implant corresponding to the implant model is prepared through additive manufacturing, so that the accuracy of the prepared degradable implant can be ensured, and the degradable implant can be well attached to the inner wall of the uterine cavity of a patient.
The degradable implant is composed of concave-type folded elastic single bodies which expand and contract in the circumferential direction and the axial direction of the degradable implant; when the degradable implant is not stretched, the geometric shape of the degradable implant is matched with the outline of the uterine cavity of a patient; after the degradable implant is stretched, the outer geometric shape of the degradable implant is deformed into a cylindrical shape. Thereby can be in before the degradable implant is placed into patient's palace intracavity, can be through stretching the degradable implant makes the outer deformation of geometry of degradable implant forms the tube-shape, thereby need not to expand the palace when the degradable implant is placed, has also improved the convenience of placing the operation of implant, can reduce and avoid bringing new damage and pain when the operation even, to sum up can effectively reduce the possibility that patient's postoperative palace chamber adhesion recurs. In addition, the implant adopted by the invention is a degradable implant, so that the increase of operation complexity and the formation of new wounds caused by repeated placement and removal can be avoided, and the use safety of the degradable implant is improved.
Step S200 is a step of generating a corresponding implant model according to the uterine cavity information, and comprises the following steps:
step S210, determining an endometrium curved surface to be covered according to the uterine cavity information, and taking a contour boundary of the endometrium curved surface expanded outwards in a first preset distance range towards the direction of a normal line below a membrane as the outline of the uterine cavity of a patient;
and S220, generating an implant model corresponding to the outline of the uterine cavity of the patient according to the outline of the uterine cavity.
After obtaining the uterine cavity information of the patient, the endometrium curved surface to be covered can be determined through the three-dimensional structure of the uterine cavity of the patient and the adhesion separation area of the uterine cavity of the patient, and a target placement area of the degradable implant can be included. In order to further ensure that the degradable implant can be stably attached to the inner wall of the uterine cavity of a patient, a contour boundary of the endometrial curve of the uterine cavity, which is expanded towards the subintimal normal direction (namely the direction of the endometrial functional layer of the uterine cavity to the basal layer) within a first preset distance range, is adopted as the outline of the uterine cavity of the patient. Wherein the first preset distance range is 0.1-2.5mm. The area of the degradable implant covering the uterine cavity can reach 15-50%, and the outward expansion distance of one end of the degradable implant close to the bottom of the uterine cavity is smaller than that of one end close to the top of the uterine cavity. Thereby generating an implant model corresponding to the patient's uterine cavity contour based on the uterine cavity contour.
In this embodiment, the endometrium curved surface to be covered is determined according to the uterine cavity information, a contour boundary within a first preset distance range extending outwards from the endometrium curved surface to the direction of the sub-membrane normal line is used as the external contour of the uterine cavity of the patient, and an implant model corresponding to the external contour of the uterine cavity of the patient is generated according to the external contour of the uterine cavity. So that the difference of the first preset distance range exists between the outline of the implant model and the curved surface of the endometrium to be covered, and the degradable implant prepared based on the implant model is stably fixed in the uterine cavity of the patient.
It should be noted that, in this document, relational terms such as first and second, and the like are only used for distinguishing one entity/operation/object from another entity/operation/object, and do not necessarily require or imply any actual relationship or order between these entities/operations/objects; the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or system that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or system. Without further limitation, an element defined by the phrases "comprising a," "8230," "8230," or "comprising" does not exclude the presence of other like elements in a process, method, article, or system comprising the element.
The above-mentioned serial numbers of the embodiments of the present invention are only for description, and do not represent the advantages and disadvantages of the embodiments.
The above description is only a preferred embodiment of the present invention, and is not intended to limit the scope of the present invention, and all equivalent structures or equivalent processes performed by the present invention or directly or indirectly applied to other related technical fields are also included in the scope of the present invention.
Claims (10)
1. A degradable implant for preventing intrauterine adhesion is characterized in that the degradable implant is composed of concave folded elastic single bodies, wherein the concave folded elastic single bodies are expanded and contracted in the circumferential direction and the axial direction of the degradable implant; when the degradable implant is not stretched, the geometric shape of the degradable implant is matched with the outline of the uterine cavity of a patient; after the degradable implant is stretched, the outer geometric shape of the degradable implant is deformed into a cylindrical shape.
2. The degradable implant for preventing intrauterine adhesion of claim 1, wherein the composition materials of the degradable implant are 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, and the specified drug is loaded on the outer surface or inside of the matrix material.
3. The degradable implant for preventing intrauterine adhesion of claim 2, wherein said degradable polymer is at least one of polylactic acid, polycaprolactone and polylactic glycolic acid copolymer; the degradable biological ceramic is at least one of calcium silicate, calcium phosphate and biological glass; the mass fraction range of the degradable biological ceramics in the composite material is 0-50wt%.
4. The degradable implant for preventing intrauterine adhesion of claim 2, wherein said prescribed drug comprises at least one of estrogen, antibiotic-type drug and growth factor.
5. The degradable implant for preventing intrauterine adhesion of claim 1, wherein each concave-type folded elastic monomer is connected with each other by a circular arc-shaped connecting beam.
6. The degradable implant for preventing intrauterine adhesion of claim 1, wherein a tensile retainer ring is disposed at one end of the degradable implant near the bottom of the uterine cavity for preventing effusion from leaking out.
7. The degradable implant for preventing intrauterine adhesion of claim 6, wherein the extension retaining ring is provided with an external interface for connecting a drainage device to lead out effusion.
8. The degradable implant for preventing intrauterine adhesion of claim 1, wherein said degradable implant has an initial degradation rate of less than 0.15mm/y, a middle degradation rate of 0.15-0.4mm/y and a long degradation rate of more than 0.4mm/y until the degradable implant is completely degraded.
9. A preparation method of a degradable implant for preventing intrauterine adhesion is characterized by comprising the following steps:
obtaining uterine cavity information of a patient;
generating a corresponding implant model according to the uterine cavity information;
preparing a degradable implant corresponding to the implant model through additive manufacturing, wherein the degradable implant is composed of concave-type folded elastic single bodies which expand and contract in the circumferential direction and the axial direction of the degradable implant; when the degradable implant is not stretched, the geometric shape of the degradable implant is matched with the outline of the uterine cavity of a patient; after the degradable implant is stretched, the outer geometric shape of the degradable implant is deformed into a cylindrical shape.
10. The method for preparing the degradable implant for preventing the intrauterine adhesion according to claim 9, wherein the step of generating the corresponding implant model according to the intrauterine information comprises:
determining an inner membrane curved surface of the uterine cavity to be covered according to the information of the uterine cavity, and taking a contour boundary of the inner membrane curved surface of the uterine cavity, which is expanded outwards in a first preset distance range towards the direction of a normal line below the uterine cavity, as the contour of the uterine cavity of a patient;
and generating an implant model corresponding to the outline of the uterine cavity of the patient according to the outline of the uterine cavity.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211504616.3A CN115590654B (en) | 2022-11-29 | 2022-11-29 | Degradable implant for preventing intrauterine adhesion and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211504616.3A CN115590654B (en) | 2022-11-29 | 2022-11-29 | Degradable implant for preventing intrauterine adhesion and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN115590654A true CN115590654A (en) | 2023-01-13 |
| CN115590654B CN115590654B (en) | 2023-03-14 |
Family
ID=84851988
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202211504616.3A Active CN115590654B (en) | 2022-11-29 | 2022-11-29 | Degradable implant for preventing intrauterine adhesion and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN115590654B (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117084836A (en) * | 2023-08-11 | 2023-11-21 | 北京尚宁科智医疗器械有限公司 | Release system of degradable metallic material uterine cavity bracket |
Citations (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000042946A1 (en) * | 1999-01-22 | 2000-07-27 | Al Saadon Khalid | Expandable intravascular tubular stents |
| US20050228486A1 (en) * | 2004-04-13 | 2005-10-13 | Case Brian C | Implantable frame with variable compliance |
| CN102711677A (en) * | 2009-10-06 | 2012-10-03 | 动脉再造技术股份有限公司 | Bioresorbable vascular implant having homogenously distributed stresses under a radial load |
| CN104127266A (en) * | 2014-06-16 | 2014-11-05 | 苏州固基电子科技有限公司 | Drug-loading vascular stent |
| CN104998342A (en) * | 2015-07-22 | 2015-10-28 | 严聪颖 | Medicine-carrying slow release apparatus for uterus, and implantation method thereof |
| CN106618821A (en) * | 2017-01-06 | 2017-05-10 | 青岛市第三人民医院 | Intravascular stent capable of preventing vascular restenosis and preparation method of intravascular stent |
| US20170196714A1 (en) * | 2007-02-09 | 2017-07-13 | Taheri Laduca Llc | Vascular implants and methods of fabricating the same |
| CN107744417A (en) * | 2017-10-18 | 2018-03-02 | 易浦润（上海）生物技术有限公司 | One kind can post-operation adhesion preventing apparatus in degradable uterine cavity |
| US20190021842A1 (en) * | 2017-07-19 | 2019-01-24 | Cook Medical Technologies Llc | Non-cylindrical variable pitch mesh top stent |
| CN208552221U (en) * | 2017-11-08 | 2019-03-01 | 柏文有限责任公司 | Lesions of ears system frame |
| CN111067679A (en) * | 2020-03-02 | 2020-04-28 | 南京浩衍鼎业科技技术有限公司 | Intracranial degradable polyester stent with high support strength |
| CN210990958U (en) * | 2019-08-16 | 2020-07-14 | 上海七木医疗器械有限公司 | Layered degradable polymer stent |
| CN112494189A (en) * | 2020-11-03 | 2021-03-16 | 北京科技大学 | Degradable metal uterine cavity stent and release system and use method |
| CN213310619U (en) * | 2020-09-04 | 2021-06-01 | 苏州市美新迪斯医疗科技有限公司 | Degradable stent with adjustable outer diameter |
-
2022
- 2022-11-29 CN CN202211504616.3A patent/CN115590654B/en active Active
Patent Citations (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2000042946A1 (en) * | 1999-01-22 | 2000-07-27 | Al Saadon Khalid | Expandable intravascular tubular stents |
| US20050228486A1 (en) * | 2004-04-13 | 2005-10-13 | Case Brian C | Implantable frame with variable compliance |
| US20170196714A1 (en) * | 2007-02-09 | 2017-07-13 | Taheri Laduca Llc | Vascular implants and methods of fabricating the same |
| CN102711677A (en) * | 2009-10-06 | 2012-10-03 | 动脉再造技术股份有限公司 | Bioresorbable vascular implant having homogenously distributed stresses under a radial load |
| CN104127266A (en) * | 2014-06-16 | 2014-11-05 | 苏州固基电子科技有限公司 | Drug-loading vascular stent |
| CN104998342A (en) * | 2015-07-22 | 2015-10-28 | 严聪颖 | Medicine-carrying slow release apparatus for uterus, and implantation method thereof |
| CN106618821A (en) * | 2017-01-06 | 2017-05-10 | 青岛市第三人民医院 | Intravascular stent capable of preventing vascular restenosis and preparation method of intravascular stent |
| US20190021842A1 (en) * | 2017-07-19 | 2019-01-24 | Cook Medical Technologies Llc | Non-cylindrical variable pitch mesh top stent |
| CN107744417A (en) * | 2017-10-18 | 2018-03-02 | 易浦润（上海）生物技术有限公司 | One kind can post-operation adhesion preventing apparatus in degradable uterine cavity |
| CN208552221U (en) * | 2017-11-08 | 2019-03-01 | 柏文有限责任公司 | Lesions of ears system frame |
| CN210990958U (en) * | 2019-08-16 | 2020-07-14 | 上海七木医疗器械有限公司 | Layered degradable polymer stent |
| CN111067679A (en) * | 2020-03-02 | 2020-04-28 | 南京浩衍鼎业科技技术有限公司 | Intracranial degradable polyester stent with high support strength |
| CN213310619U (en) * | 2020-09-04 | 2021-06-01 | 苏州市美新迪斯医疗科技有限公司 | Degradable stent with adjustable outer diameter |
| CN112494189A (en) * | 2020-11-03 | 2021-03-16 | 北京科技大学 | Degradable metal uterine cavity stent and release system and use method |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117084836A (en) * | 2023-08-11 | 2023-11-21 | 北京尚宁科智医疗器械有限公司 | Release system of degradable metallic material uterine cavity bracket |
Also Published As
| Publication number | Publication date |
|---|---|
| CN115590654B (en) | 2023-03-14 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| AU2007307639B2 (en) | Method and apparatus for occluding a lumen | |
| EP1722732B1 (en) | Device for conduit occlusion | |
| CN102368966B (en) | Cervical occluder | |
| CN107744417B (en) | One kind can post-operation adhesion preventing instrument in degradable uterine cavity | |
| CN102657546B (en) | Carrier barrier system applied to prevention and treatment of metrosynizesis | |
| CN115590654B (en) | Degradable implant for preventing intrauterine adhesion and preparation method thereof | |
| JPS5967969A (en) | Cathetel stayed in cervical canal | |
| CN109925538A (en) | A kind of elastic membrane, preparation method and application | |
| US5562654A (en) | Time-released delivery system | |
| US20180000517A1 (en) | Anti-adhesion intrauterine balloon | |
| CN109513097B (en) | Double-tube saccule support for preventing and treating intrauterine adhesion | |
| CN110559061A (en) | anti-adhesion tension-free uterine cavity conformable barrier and using method thereof | |
| CN202859206U (en) | Carrier barrier system applied to prevention and treatment of intrauterine adhesion | |
| CN217430094U (en) | Multipurpose adjustable vagina packing and fixing device | |
| KR100365006B1 (en) | Artificial amnion device appropriate to organism | |
| CN209885005U (en) | Double-tube sacculus support for preventing and treating intrauterine adhesion | |
| CN203539420U (en) | Medicine-distribution type uterus stent | |
| US11426294B2 (en) | Degradable foldable biological amniotic membrane composite repair stent | |
| CN214285112U (en) | Amniotic sac supporting device for preventing abortion | |
| CN219423546U (en) | Annular medicine device of putting of degradable in uterine cavity | |
| CN211633753U (en) | Estradiol slow-release uterine cavity anti-adhesion stent | |
| CN212439690U (en) | Multifunctional intrauterine adhesion prevention and treatment device | |
| CN213911658U (en) | Cervical supporting and continuous drainage instrument | |
| CN212662450U (en) | Expansion defecation device for stoma patient | |
| Liao et al. | Effect of Chitosan-assisted Combination of Laparoscope and Hysteroscope on the Levels of IFN-γ and ICAM-1 in Treatment of Infertility Caused by Obstruction of Fallopian Tubes |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |