Implants and implantation methods during male posterior urethral resection and reconstruction surgery

Abstract

The present application provides an implant and an implantation method for male posterior urethral resection and reconstruction surgery, which is used to provide support and protection for the urethra-bladder anastomosis segment or urethra-bladder anastomosis segment in the patient's pelvic cavity, and includes a first support structure with a housing space and an opening and closing structure, wherein when the opening and closing structure is in an open state, the housing space can be opened to allow the urethra-bladder anastomosis segment or urethra-bladder anastomosis segment to enter the housing space through the opening and closing structure; when the opening and closing structure is in a closed state, the housing space can be completely or partially closed to allow the urethra-bladder anastomosis segment or urethra-bladder anastomosis segment to be positioned in the housing space. By means of the present application, the urethra-bladder anastomosis segment or urethra-bladder anastomosis segment of the patient can be supported and shaped, so as to facilitate the recovery of urinary control and sexual function of the patient after surgery.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an implant used in male posterior urethra resection and reconstruction surgery and an implantation method thereof. Background Art

[0002] The male urethra starts from the internal urethral opening at the bladder neck and ends at the external urethral opening. It has the functions of urination and ejaculation. It is about 16-22cm long, with an average diameter of 5-7mm. It can be divided into the urethral spongiosum, bulbar, membranous and prostatic parts. Clinically, the part from the external urethral opening, the urethral spongiosum to the bulbar part is called the anterior urethra; the part from the urethral membranous part, the prostatic part of the urethra to the bladder neck opening is called the posterior urethra. Among them, the urethral membranous part is about 1cm long and is surrounded by the urethral striated sphincter (i.e., the external urethral sphincter) innervated by the somatic nerves. It can achieve urine control through conscious control; the prostatic part of the urethra is the part of the urethra that passes through the prostate, which is about 2.5cm long. The male lower urinary tract is composed of the bladder and urethra. Radical surgical resection of prostate malignant tumors requires complete resection of the prostate and seminal vesicles before re-anastomosis of the bladder neck and urethra. Radical surgical resection of muscle-invasive bladder malignant tumors requires the removal of the bladder, prostate, and seminal vesicles. Urethral reconstruction for such patients mainly involves three modes. In addition to ureterostomy and enterocystostomy, some patients can also undergo enterocystostomy in situ neobladder reconstruction. Such patients also involve similar anastomosis of the bladder and urethra. For the above two types of patients who have undergone posterior urethral resection and reconstruction, common postoperative complications are transient or permanent loss of urinary control and sexual function.

[0003] Prostate cancer (PCa) is the second most common malignant tumor in men worldwide. Radical prostatectomy (RP) can achieve ideal tumor control effects, with a 5-year survival rate of more than 99% for organ-confined PCa. Although the long-term urinary control recovery rate is usually more than 90%, the immediate urinary control recovery rate after catheter removal is only about 25%, and even for early patients who underwent nerve-sparing RP surgery, the sexual function recovery rate 3 months after surgery is only about 38%. Bladder cancer (BCa) is also one of the most common urogenital tumors. It originates from the transitional epithelial cells of the bladder mucosa. According to the depth of tumor infiltration, it is mainly divided into non-muscle-invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). The former only requires local tumor resection under endoscopy, while the latter requires radical cystectomy and urethral reconstruction after the removal of the bladder, prostate and seminal vesicle. Patients who undergo intestinal replacement orthotopic neobladder surgery will also face similar problems of urinary incontinence and sexual dysfunction as those after radical prostatectomy.

[0004] In recent years, the attention paid to prostate cancer and bladder cancer in China and the early diagnosis rate have been increasing. The age and clinical stage of the patients have also gradually decreased, and the patients' requirements for postoperative quality of life have also gradually increased. For these two types of patients, the main problems currently exist include: first, the prostate capsule is surrounded by a vascular neural network responsible for controlling urinary control and sexual function, namely the neurovascular bundle (NVB); second, the fibromuscular structure of the circular striated sphincter, pelvic fascia, and levator ani muscle surrounding the membranous urethra together constitutes the urethral complex (USC). These two groups of structures are important components responsible for male urinary control, and surgical operations will inevitably cause varying degrees of disconnection and damage to these neurovascular networks and fibromuscular structures. Secondly, the thermal damage caused by the electroresection and electrocoagulation hemostasis of surgical instruments and the traction damage caused by the separation operation will also have a reversible or irreversible effect on the recovery of postoperative urinary control. In addition, the trauma of surgery to local tissues can cause the body to produce a stress-induced inflammatory response, leading to transient anastomotic edema, neuropraxia, and other processes, which can lead to delayed anastomotic healing and delayed recovery of postoperative urinary control and sexual function. Excessive anastomotic tension, insufficient water tightness, and insufficient support around the urethra complex are also important factors that restrict postoperative urinary control and sexual function recovery.

[0005] Based on the existing knowledge, many studies have proposed improved surgical techniques, such as a five-level classification system for the range of vascular nerve bundle resection when preserving the sexual nerve, a cold knife cutting pattern to reduce the risk of neuropraxia, surgical techniques to improve the function of the periurethral complex (such as preserving the retropubic space, preserving the bladder neck, preserving the length of the urethral stump, periurethral myofascial reconstruction and suspension method, etc.), and local implantation of degradable membrane materials to promote NVB healing. All of these have achieved certain improvements, but there is no relevant research on the integration and comprehensive improvement of the above factors.

[0006] In view of this, the present application intends to design an implantable material to be placed around the urethral anastomosis during surgery. The material has comprehensive effects such as three-dimensional conformality, urethral shaping, local support, anti-inflammatory and healing, and is expected to further improve the urinary control and sexual function recovery effects after male posterior urethral resection and reconstruction surgery. Summary of the invention

[0007] In view of the above problems, the main purpose of this application is to provide an intraoperative implant and implant method for male posterior urethral resection and reconstruction surgery, which is used to provide support and shaping for the patient's urethra-bladder anastomosis segment or urethra-bladder anastomosis segment, so as to facilitate the patient's postoperative recovery of urinary control and sexual function.

[0008] The present application provides an implant for male posterior urethral resection and reconstruction surgery, which is used to provide support and protection for a urethra-bladder anastomosis section or a urethra-bladder substitute anastomosis section in a patient's pelvic cavity, and is characterized in that the implant for male posterior urethral resection and reconstruction surgery comprises: a first supporting structure and an opening and closing structure, wherein the first supporting structure has a housing body, and a housing space is formed inside the housing body; the opening and closing structure is arranged on the first supporting structure; wherein, when the opening and closing structure is in an open state, the housing space in the housing body can be opened to allow the urethra-bladder anastomosis section or the urethra-bladder substitute anastomosis section to enter the housing space through the opening and closing structure; and when the opening and closing structure is in a closed state, the housing space of the housing body can be completely closed or incompletely closed to position the urethra-bladder anastomosis section or the urethra-bladder substitute anastomosis section in the housing space, thereby providing support and shaping for the urethra-bladder anastomosis section or the urethra-bladder substitute anastomosis section.

[0009] Optionally, in an embodiment of the present application, the housing body further has an inner wall of the housing body for defining the housing space, and the inner wall of the housing body is also covered with a first functional factor layer for providing anti-inflammatory, anti-fibrosis and promoting vascular tissue growth and repair functions for the urethra-bladder anastomosis segment or the urethra-surrogate bladder anastomosis segment.

[0010] Optionally, in an embodiment of the present application, the implant during male posterior urethra resection and reconstruction surgery also includes a second supporting structure, wherein the opening and closing structure is also provided on the second supporting structure, and when the opening and closing structure is in the closed state, the second supporting structure is covered on the outside of the first supporting structure, so as to provide support and shaping for the first supporting structure and prevent the surrounding tissue in the pelvic cavity from squeezing the urethra-bladder anastomosis segment or the urethra-bladder anastomosis segment in the accommodating space.

[0011] Optionally, in an embodiment of the present application, when the opening and closing structure is in the closed state, the outer shape of the second support structure is adapted to the shape of a cavity formed in the patient's pelvic cavity after the prostate of the patient is removed.

[0012] Optionally, in the embodiment of the present application, when the opening and closing structure is in the closed state, the outer shape of the second supporting structure is preferably an inverted cone.

[0013] Optionally, in an embodiment of the present application, the second support structure also has an outer side wall, and a second functional factor layer on the outer side wall, which is used to guide the growth and repair of the peri-prostatic nerve bundle in the pelvic cavity, and / or to provide anti-fibrosis, anti-inflammatory, and vascular tissue growth and repair functions for the surrounding tissues in the pelvic cavity.

[0014] Optionally, in an embodiment of the present application, the second functional factor layer is constructed of a degradable material or a non-degradable material.

[0015] Optionally, in an embodiment of the present application, the first supporting structure has a first hardness, and the second supporting structure has a second hardness.

[0016] Optionally, in an embodiment of the present application, the first hardness is the same as the second hardness, or the first hardness is greater than the second hardness.

[0017] Optionally, in an embodiment of the present application, the implant during male posterior urethra resection and reconstruction surgery further has a transition structure, which is sandwiched between the first supporting structure and the second supporting structure.

[0018] Optionally, in an embodiment of the present application, the transition structure has a third hardness, wherein the second hardness ≤ the third hardness ≤ the first hardness.

[0019] Optionally, in an embodiment of the present application, the transition structure is a multi-layer structure.

[0020] Optionally, in the embodiment of the present application, the hardness of the transition structure preferably gradually decreases from an inner layer adjacent to the first supporting structure to an outer layer adjacent to the second supporting structure.

[0021] Optionally, in an embodiment of the present application, the materials of the first support structure and the second support structure are the same or different, and the materials of the first support structure and the second support structure are selected from degradable materials, non-degradable materials, or a combination of degradable materials and non-degradable materials.

[0022] Optionally, in an embodiment of the present application, the second support structure is further provided with a positioning structure, and the positioning structure is adapted to the neck structure of the bladder. By making the positioning structure and the neck of the bladder fit each other, the implant can be positioned around the anastomosis between the patient's urethra and bladder or around the anastomosis between the patient's urethra and substitute bladder during the male posterior urethra resection and reconstruction surgery.

[0023] Optionally, in an embodiment of the present application, the implant during male posterior urethra resection and reconstruction surgery also includes an auxiliary fixation device, which can be fixedly connected to the surrounding tissues or pubic bone in the pelvic cavity to provide the implant during male posterior urethra resection and reconstruction surgery to be positioned around the anastomosis between the patient's urethra and bladder or around the anastomosis between the patient's urethra and substitute bladder.

[0024] Optionally, in the embodiment of the present application, the opening and closing structure is maintained in the closed state by suturing and / or snapping.

[0025] Optionally, in an embodiment of the present application, the first supporting structure includes a plurality of first supporting units, wherein the first supporting units are combined with each other to form the first supporting structure.

[0026] Optionally, in an embodiment of the present application, the volume of the space occupied by the implant in the patient's pelvic cavity during the male posterior urethra resection and reconstruction surgery is between 5 ml and 40 ml.

[0027] Optionally, in an embodiment of the present application, the volume of space occupied by the implant in the patient's pelvic cavity during the male posterior urethra resection and reconstruction surgery is between 10 ml and 30 ml, wherein the volume of space is preferably 20 ml.

[0028] Optionally, in an embodiment of the present application, the transverse diameter of the implant during male posterior urethra resection and reconstruction surgery is between 3 cm and 6 cm, the longitudinal diameter is between 1 cm and 5 cm, and the anterior-posterior diameter is between 2 cm and 4 cm, and wherein the transverse diameter of the implant during male posterior urethra resection and reconstruction surgery is preferably 4.2 cm, the longitudinal diameter is preferably 3.2 cm, and the anterior-posterior diameter is preferably 2.8 cm.

[0029] The present application also provides a method for implanting an implant during male posterior urethra resection and reconstruction surgery, which comprises: after performing urethral bladder anastomosis or urethral bladder replacement anastomosis during radical prostatectomy or radical bladder cancer in situ intestinal replacement bladder surgery, providing the male posterior urethra resection and reconstruction surgery implant according to the above-mentioned method; making the opening and closing structure of the male posterior urethra resection and reconstruction surgery implant in the open state to open the accommodation space of the accommodation body; placing the male posterior urethra resection and reconstruction surgery implant in the patient's pelvic cavity. The opening and closing structure is used to open and close the urethra and bladder or substitute bladder, and provide the patient's urethra-bladder anastomosis section or urethra-substitute bladder anastomosis section to enter the accommodating space through the opening and closing structure; and the opening and closing structure is switched from the open state to the closed state to completely close or incompletely close the accommodating space of the accommodating body, so that the urethra-bladder anastomosis section or the urethra-substitute bladder anastomosis section is positioned in the accommodating space, and support and shaping are provided for the urethra-bladder anastomosis section or the urethra-substitute bladder anastomosis section.

[0030] It can be seen from the above technical scheme that the intraoperative implant for male posterior urethra resection and reconstruction surgery provided in the embodiment of the present application enables the opening and closing structure to be in an open state so that the patient's urethra-bladder anastomosis segment or the urethra-bladder substitute anastomosis segment can enter the accommodating space of the first support structure through the opening and closing structure, and enables the opening and closing structure to be switched to a closed state to completely or partially close the accommodating space so that the urethra-bladder anastomosis segment or the urethra-bladder substitute anastomosis segment can be positioned in the accommodating space, thereby providing support and plasticity to the urethra-bladder anastomosis segment or the urethra-bladder substitute anastomosis segment, so as to facilitate the recovery of the patient's urinary control ability after surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the embodiments of the present application. For ordinary technicians in this field, other drawings can also be obtained based on these drawings.

[0032] Figure 1A and Figure 1B A schematic diagram showing an embodiment of an implant used in male posterior urethra resection and reconstruction surgery of the present application;

[0033] FIG. 2A to FIG. 2C A schematic diagram showing another embodiment of an implant used in male posterior urethra resection and reconstruction surgery of the present application;

[0034] FIG. 3A to FIG. 3C A schematic diagram showing an embodiment of placing an implant in a patient's pelvic cavity during male posterior urethral resection and reconstruction surgery of the present application;

[0035] FIG. 4A to FIG. 4C A schematic diagram showing an embodiment of the degradation state of an implant at different stages during male posterior urethra resection and reconstruction surgery of the present application;

[0036] FIG. 5A to FIG. 5B A schematic diagram showing another embodiment of an implant used in male posterior urethra resection and reconstruction surgery of the present application;

[0037] FIG. 6A to FIG. 6C A schematic diagram showing an example of a second functional factor layer of an implant during male posterior urethra resection and reconstruction surgery of the present application;

[0038] Figure 7 A schematic diagram showing an embodiment of a transition structure of an implant during male posterior urethra resection and reconstruction surgery of the present application;

[0039] FIG. 8A to FIG. 8C A schematic diagram showing different ways of fixing the implant in the male posterior urethra resection and reconstruction surgery of the present application;

[0040] 9A to 9D A schematic diagram showing an embodiment of the present invention in which the opening and closing structure of the implant is in a closed state during male posterior urethral resection and reconstruction surgery;

[0041] FIG. 10A to FIG. 10C A schematic diagram showing an embodiment of the present invention in which the opening and closing structure of the implant is in an open state during male posterior urethral resection and reconstruction surgery;

[0042] FIG. 11A to FIG. 11C A schematic diagram showing another embodiment of an implant during male posterior urethra resection and reconstruction surgery of the present application; and

[0043] FIG. 12A to FIG. 12E The present invention is a schematic diagram showing different combinations of implants used in male posterior urethra resection and reconstruction surgery.

[0044] Component number

[0045]

[0046] DETAILED DESCRIPTION

[0047] In order to enable those skilled in the art to better understand the technical solutions in the embodiments of the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments in the embodiments of the present application should fall within the scope of protection of the embodiments of the present application.

[0048] The implant 1 (hereinafter referred to as implant 1) used in male posterior urethral resection and reconstruction surgery of the present invention is used to provide support and protection for the urethra-vesical anastomosis section 2 or urethra-vesical anastomosis section 2' in the patient's pelvic cavity (with reference to FIG. 3A to FIG. 3C ),in, Figure 3A and Figure 3B The schematic diagram shows that the implant 1 provides support and protection for the urethra-vesical anastomosis section 2 in the patient's pelvic cavity, wherein the urethra-vesical anastomosis section 2 referred to in the present application is located at the peripheral position of the anastomosis between the patient's urethra 3 and bladder 4 after the patient's prostate is removed (i.e., above the urethra-pelvic cavity outlet, on the inner side of the pelvis and pelvic muscles). However, this is not limited to this. Figure 3A and Figure 3B The bladder 4 in the embodiment may also be replaced by a substitute bladder 4' (eg Figure 3C As shown), it refers to the use of the ileum to replace the removed bladder to form a substitute bladder 4' after the patient's bladder is removed during surgery.

[0049] In order to simplify the explanation and avoid confusing the technical focus of this case, in the following description, the implant 1 of this application is described in detail only by using the implant 1 to provide support and protection for the urethra-vesical anastomosis segment 2 in the patient's pelvic cavity. It should be noted that in actual applications, the urethra-vesical anastomosis segment 2 referred to in the following specifications can be replaced by the urethra-vesical anastomosis segment 2', which should be stated first.

[0050] In the embodiments of the present application, the implant 1 is mainly used to replace the resected prostate after the prostate of the patient is removed to fill the potential cavity, thereby providing support and protection for the urethra-vesical anastomosis section 2 of the patient. Figure 1A and Figure 1BThe schematic diagram of the overall structure of an embodiment of the implant 1 of the present application is shown. In this embodiment, the implant 1 is mainly composed of a first support structure 11 and an opening and closing structure 12. The first support structure 11 has a housing 110, and a housing space 1101 is formed inside the housing 110. The opening and closing structure 12 is disposed on the first support structure 11 and can provide switching between an open state and a closed state. Among them, when the opening and closing structure 12 is in an open state, the accommodating space 1101 inside the accommodating body 110 can be opened to provide the patient's urethra-vesical anastomosis section 2 to enter the accommodating space 1101 of the first supporting structure 11 through the opening and closing structure 12 in the open state; and when the opening and closing structure 12 is in a closed state, the accommodating space 1101 of the accommodating body 110 can be completely closed or incompletely closed, so that the patient's urethra-vesical anastomosis section 2 can be positioned in the accommodating space 1101 of the first supporting structure 11, thereby providing support and shaping for the urethra-vesical anastomosis section 2 accommodated therein by virtue of the structural strength of the first supporting structure 11 itself.

[0051] exist Figure 1B In the figure, a schematic diagram is shown in which the accommodating space 1101 of the accommodating body 110 is in an incompletely closed state when the opening and closing structure 12 is in a closed state, that is, the cross-section of the accommodating space 1101 of the accommodating body 110 is C-shaped, but it is not limited to this. When the opening and closing structure 12 is in a closed state, the accommodating space 1101 of the accommodating body 110 may also be in a completely closed state, for example, the cross-section of the accommodating space 1101 of the accommodating body 110 is O-shaped.

[0052] In addition, it should be noted that the cross-section of the accommodating space 1101 of the accommodating body 110 is not limited to the above-mentioned C-shaped state or O-shaped state. In other embodiments, the inner surface shape of the accommodating space 1101 (such as a funnel shape, etc.) can be arbitrarily changed according to actual needs, so that the inner surface shape of the accommodating space 1101 is adapted to the actual shape of the patient's urethra-vesical anastomosis section 2, thereby providing better positioning and support effects (please describe in detail later).

[0053] In addition, the first support structure 11 and the opening and closing structure 12 constituting the implant 1 can be designed to be integrally formed. Figure 1A and Figure 1B In the embodiment shown, the opening and closing structure 12 is designed as an opening formed on the side wall of the first supporting structure 11 along the axial direction of the first supporting structure 11, but it is not limited to this. The first supporting structure 11 and the opening and closing structure 12 can also be designed as two relatively independent structural components according to actual needs.

[0054] like Figure 2AAs shown, in this embodiment, the opening and closing structure 12 is further formed with a stitching unit / clamping unit 121, which is used to provide the opening and closing structure 12 to maintain the closed state by stitching and / or clamping. However, this is not limited to this, and the opening and closing structure 12 can also be maintained in the closed state by other methods.

[0055] In one embodiment, the material constituting the first support structure 11 can be selected from a degradable material, a non-degradable material, or a combination of a degradable material and a non-degradable material. Specifically, the first support structure 11 can be, for example, a biocompatible material, and its material is composed of a degradable polymer material, including but not limited to: poly (caprolactone), polycarbonate, polyamide ester, polyanhydride, poly (amino acid), polycyanoacrylate, polyamide, polyacetal, poly (ether ester), poly (dioxanone), poly (alkylene alkyl), biodegradable polyurethane, blends and / or copolymers of the above materials, which is used to support and protect the patient's urethral bladder anastomosis segment 2 for a certain period of time after surgery, and can be self-degraded after the patient recovers function.

[0056] Furthermore, the non-degradable material constituting the first supporting structure 11 may be, for example, a metal material, including but not limited to titanium alloy and nickel-titanium alloy; the non-degradable material may also be, for example, a polymer material, including but not limited to: polyethylene glycol, polyethylene glycol (PEG) acrylate, polymethacrylate (for example, PEG methacrylate, polymethyl methacrylate, polyethyl methacrylate, polybutyl methacrylate, poly-2-ethylhexyl methacrylate, polydodecyl methacrylate, polyhydroxyethyl methacrylate), polymethyl acrylate, 2-methacryloyloxyethyl phosphorylcholine (MPC), polystyrene, derived polystyrene, polylysine, poly-N-ethyl-4-vinyl-pyridinium bromide, silicone, ethylene-vinyl acetate copolymer, polyethylene, polypropylene, polytetrafluoroethylene, polyurethane, polyacrylate, polyethylene acetate, ethylene vinyl acetate, polyethylene, polyvinyl chloride, polyvinyl fluoride, copolymers of ethylene vinyl acetate and acyl-substituted cellulose acetate polymers, poly(vinylimidazole), chlorosulfonated polyolefins, polyethylene oxide, and mixtures of the above materials.

[0057] Please continue reading Figure 1A and Figure 1B In another embodiment, the housing body 110 further has an inner wall 111 for defining the housing space 1101, and a first functional factor layer 112 is coated on the inner wall 111 of the housing body, which can be used to provide anti-inflammatory, anti-fibrosis and vascular tissue growth and repair functions for the urethra-vesical anastomosis section 2 positioned in the housing space 1101, thereby avoiding the generation of fibrotic tissue near the urethra-vesical anastomosis section 2, forming scars and affecting urination.

[0058] In this embodiment, the composite drugs contained in the first functional factor layer 112 mainly include anti-fibrosis, anti-scar drugs (for example: TGF-β1 / 2 receptor inhibitors (such as LY364947), TGF-β3 analogs (such as Avotermin), valproic acid, etc.) and materials promoting tissue growth and repair (urethral anastomotic cells (derived from pig bladder extracellular matrix (UB-ECM))

[0059] Please refer to FIG. 2A to FIG. 2C , which is a structural schematic diagram showing another embodiment of the implant 1 of the present application. In this embodiment, the implant 1 also includes a second support structure 13, wherein the opening and closing structure 12 is also arranged on the second support structure 13, wherein when the opening and closing structure 12 is in an open state, the first support structure 11 and the second support structure 13 are opened simultaneously to open the accommodation space 1101 in the accommodation body 110, and when the opening and closing structure 12 is in a closed state, the second support structure 13 is covered on the outside of the first support structure 11 (i.e., the outside of the accommodation space 1101 of the accommodation body 110 that is completely closed or not completely closed), so as to further provide support and shaping for the first support structure 11 by means of the second support structure 13, thereby preventing the surrounding tissues in the patient's pelvic cavity from squeezing the urethra-vesical anastomosis section 2 in the accommodation space 1101 of the first support structure 11, and at the same time limiting the urethra-vesical anastomosis section 2 from squeezing the surrounding sphincter due to excessive expansion of the urethra due to urine filling. When the opening and closing structure 12 is in the closed state, the overall shape of the implant 1 can be referred to 9A to 9C As shown in the schematic diagram, when the opening and closing structure 12 is in the open state, the overall shape of the implant 1 can be referred to FIG. 10A to FIG. 10C Schematic diagram shown.

[0060] In a preferred embodiment of the present application, when the opening and closing structure 12 is in a closed state, the outer shape of the second support structure 13 can be adapted to the shape of the cavity formed in the patient's pelvic cavity after the prostate of the patient is removed. For example, the outer shape of the second support structure 13 is preferably designed to be an inverted cone (e.g., a chestnut shape), that is, the cross-sectional circumference of the outer shape of the second support structure 13 gradually increases and then decreases, wherein the tip of the second support structure 13 is close to the urethra exiting the pelvic cavity, and the bottom is toward the bladder (e.g., Figure 2A shown).

[0061] In addition, the material of the second support structure 13 may be the same as or different from the material of the first support structure 11, wherein the material constituting the second support structure 13 may also be selected from a degradable material, a non-degradable material, or a combination of a degradable material and a non-degradable material. Specifically, the degradable polymer material includes, but is not limited to: poly(caprolactone), polycarbonate, polyamide ester, polyanhydride, poly(amino acid), polycyanoacrylate, polyamide, polyacetal, poly(ether ester), poly(dioxanone), poly(alkylene alkylate), biodegradable polyurethane, blends and / or copolymers of the above materials. The non-degradable material may be, for example, a metal material, including but not limited to titanium alloy and nickel-titanium alloy; the non-degradable material may also be, for example, a polymer material, including but not limited to polyethylene glycol, polyethylene glycol (PEG) acrylate, polymethacrylate (e.g., PEG methacrylate, polymethyl methacrylate, polyethyl methacrylate, polybutyl methacrylate, poly-2-ethylhexyl methacrylate, polydodecyl methacrylate, polyhydroxyethyl methacrylate), polymethyl acrylate, 2-methacryloyloxyethyl phosphorylcholine (MPC), polystyrene, derivatized polystyrene, polylysine, poly-N-ethyl-4-vinyl-pyridinium bromide, silicone, ethylene-vinyl acetate copolymer, polyethylene, polypropylene, polytetrafluoroethylene, polyurethane, polyacrylate, polyvinyl acetate, ethylene vinyl acetate, polyethylene, polyvinyl chloride, polyvinyl fluoride, copolymers of ethylene vinyl acetate and acyl-substituted cellulose acetate polymers, poly(vinylimidazole), chlorosulfonated polyolefins, polyethylene oxide, and mixtures of the above materials.

[0062] At Figure 2C In the illustrated embodiment, the first support structure 11 and the second support structure 13 are nested together by two different materials, and the inner and outer parts of the implant 1 (i.e., the inner side wall 111 of the container of the first support structure 11 and the outer side wall 131 of the second support structure 13) are respectively coated with a biocompatible coating formed by silicon or PTFE to increase the adaptability of the implant 1.

[0063] also, FIG. 4A to FIG. 4C The schematic diagram shows the degradation state of the implant 1 at different stages according to an embodiment of the present application, wherein the first support structure 11 of the implant 1 is made of a non-degradable material, and the second support structure 13 is made of a degradable material.

[0064] Furthermore, the first support structure 11 has a first hardness, and the second support structure 13 has a second hardness, wherein the first hardness and the second hardness may be the same, or the first hardness may be greater than the second hardness, so that the first support structure 11 located on the inside can provide a stronger support force for the patient's urethrovesical anastomosis section 2 to achieve a better protection effect, and the second support structure 13 located on the outside can be well integrated with the surrounding tissues in the patient's pelvic cavity due to its lower hardness, and can conform to the pressure of the surrounding tissues, and when the pressure of the surrounding tissues is eliminated, it can restore its original shape by itself, so as to improve the patient's comfort and provide a better support and buffering effect. In addition, when the first hardness is greater than the second hardness, the deformation of the second support structure 13 can be greater than the deformation of the first support structure 11, so as to maximize the opening of the accommodation space 1101 in the accommodation body 110.

[0065] like Figure 5A and Figure 5B As shown, in one embodiment of the present application, the first support structure 11 and the second support structure 13 are designed to be integrally formed, and the implant 1 composed of the first support structure 11 and the second support structure 13 has a certain thickness, which can provide better support and protection effects, wherein, Figure 5A To show that when the opening and closing structure 12 is in the closed state, the accommodating space 1101 of the accommodating body 110 is in an incompletely closed state. Figure 5B It shows that when the opening and closing structure 12 is in the open state, the second supporting structure 13 can generate local topographic deformation, so that the accommodating space 1101 in the accommodating body 110 can be expanded outward, thereby providing a larger operating space when performing the operation of inserting the urethral vesical anastomosis section 2.

[0066] Please continue reading FIG. 6A to FIG. 6C In this embodiment, the outer side wall 131 of the second support structure 13 is also coated with a second functional factor layer 132, which is mainly used to guide the growth and repair of the peri-prostatic nerve bundle in the patient's pelvic cavity. Specifically, by means of the second functional factor layer 132, the peri-prostatic nerve bundle in the patient's pelvic cavity can be gradually contracted from the side close to the patient's bladder to the side of the patient's urethra and / or the grid density can be gradually contracted, so as to provide a guiding "bridge", guide the growth direction of the nerve bundle, and promote the regeneration and repair of the nerve bundle at the bottom of the pelvic cavity.

[0067] In addition, the second functional factor layer 132 can also be used to provide anti-fibrosis, anti-inflammation, and promote the growth and repair of vascular tissues for the surrounding tissues in the patient's pelvic cavity. In this embodiment, the second functional factor layer 132 is constructed of degradable materials or non-degradable materials, and the second functional factor layer 132 can be covered on the entire surface or a specific local surface of the outer side wall 131 according to actual use requirements.

[0068] In this embodiment, the composite drugs contained in the second functional factor layer 132 mainly include: a) neuroprotective and repair drugs, including but not limited to: hyaluronic acid-sodium carboxymethylcellulose (HACM), erythropoietin (EPO), tacrolimus (FK506) analogs (such as GPI-1046), neurotrophic factors (such as BDNF, GDNF, NT-3, GDF-5 analogs, etc.), Hedgehog protein analogs, etc.; b) vasoactive drugs, including but not limited to: PDE-5 inhibitors (such as tadalafil), alprostadil, etc.; and c) nerve regeneration promoting materials, including but not limited to: chitosan membrane (ChiMe), dehydrated human chorionic membrane / amniotic membrane (dHACM), etc.

[0069] Please continue reading Figure 7 In another embodiment, the implant 1 of the present application further has a transition structure 14, which is sandwiched between the first support structure 11 and the second support structure 13. The transition structure 14 has a third hardness. In the present application, the second hardness ≤ the third hardness ≤ the first hardness. Figure 7 In the embodiment shown, the transition structure 14 can be designed as a multi-layer structure, and the hardness of the transition structure 14 preferably gradually decreases from the inner layer 141 adjacent to the first support structure 11 to the outer layer 142 adjacent to the second support structure 13. It should be noted that the number of layers constituting the transition structure 14 is not limited to Figure 7 The figure is limited. In other words, the number of layers constituting the transition structure 14 can be changed arbitrarily according to actual use requirements.

[0070] In addition, in order to increase the stability of the implant 1 in the patient's pelvic cavity and avoid uncontrollable bending of the urethra-vesical anastomosis section 2 positioned in the accommodation body 110, in one embodiment of the present application, a positioning structure 15 (such as Fig. 8A As shown), the shape of the positioning structure 15 can be designed to match the neck structure of the patient's bladder 4, so that the implant 1 is positioned around the anastomotic opening between the patient's urethra 3 and bladder 4 by making the positioning structure 15 and the neck portion of the bladder 4 fit each other (as shown in FIG. Figure 8B shown).

[0071] Furthermore, in another embodiment, a better positioning effect can be achieved by providing an auxiliary fixing device 16. Specifically, Figure 8CAs shown, the auxiliary fixing device 16 can be, for example, a plurality of mesh belts fixedly designed on the implant 1, which can be fixedly connected to the surrounding tissues or pubic bones in the patient's pelvic cavity. In this embodiment, the auxiliary fixing device 16 includes at least two mesh belts, which are centrally symmetrically distributed, wherein one end of the mesh belt can be fixed to the circumference of the implant 1, and the other end of the mesh belt can be fixedly connected to the surrounding tissues or pubic bones in the pelvic cavity, thereby allowing the implant 1 to be stably positioned around the anastomosis of the urethra 3 and the bladder 4. It should be noted that the design of the auxiliary fixing device 16 is not based on Figure 8C The mesh belt shown is limited and can also be designed as a structure such as a hook or a screw.

[0072] In one embodiment, the volume of space occupied by the implant 1 of the present application in the patient's pelvic cavity may be between 5 ml and 40 ml, preferably, the volume of space occupied by the implant 1 in the patient's pelvic cavity is between 10 ml and 30 ml, specifically, the transverse diameter of the implant 1 is between 3 cm and 6 cm, the longitudinal diameter is between 1 cm and 5 cm, and the anterior-posterior diameter is between 2 cm and 4 cm. In a preferred embodiment, the volume of space occupied by the implant 1 in the patient's pelvic cavity is 20 ml, specifically, the transverse diameter of the implant 1 is 4.2 cm, the longitudinal diameter is 3.2 cm, and the anterior-posterior diameter is 2.8 cm.

[0073] As mentioned above, the shape of the accommodation space 1101 of the accommodation body 110 of the present application is designed as follows Figure 1B In addition to the designed C-shaped state, it can also be designed into a funnel shape according to the actual shape of the patient's urethra-vesical anastomosis section 2, such as Fig.9D As shown, it is displayed Fig. 9B Schematic cross-sectional view along line BB. As shown in the figure, in this embodiment, the bladder fitting surface 1101A located on the left side of the accommodating space 1101 is designed to be wider to fit with the bladder 4 of the patient, while the urethra fitting surface 1101B located on the right side of the accommodating space 1101 is designed to be narrower to fit with the urethra 3 of the patient. In addition, the left side of the accommodating space 1101 can provide a larger surgical field of view during the operation to facilitate the surgical operation.

[0074] In addition, tissue can be filled between the accommodating space 1101 and the patient's urethra-vesical anastomosis section 2 to fill the gap between the accommodating space 1101 (i.e., the inner wall 111 of the accommodating body) and the patient's urethra-vesical anastomosis section 2. In the present application, tissues that can be used for filling include but are not limited to the greater omentum or the reflected peritoneum 5.

[0075] Please continue reading FIG. 11A to FIG. 11C In this embodiment, the bottom portion of the outer sidewall 131 of the second support structure 13 is larger than Fig.9AThe embodiment shown is slightly convex to better conform to the shape of the cavity formed in the pelvic cavity after the prostate is removed. In addition, the bottom of the inner wall 111 of the container is designed at an inclined angle, which not only matches the actual shape of the patient's prostate, but also facilitates the actual operation.

[0076] It should also be noted that, in addition to being composed of a single component, the first support structure 11 of the present application can also be formed by assembling multiple independent units, so that the first support structure 11 can be split as a whole into multiple split independent units to facilitate the rapid implantation of the implant 1 into the patient's body during surgery.

[0077] For more details, please refer to FIG. 12A to FIG. 12D The first support structure 11 may include a plurality of first support units 113, wherein each first support unit 113 may be combined with each other to form the first support structure 11. In the present application, each first support unit 113 may be arranged along the circumference of the urethra-vesical anastomosis section 2 (e.g. FIG. 12A to FIG. 12B as shown) and / or axially (as Figures 12C-12D As shown) are distributed around the urethrovesical anastomosis segment 2.

[0078] For example, in Fig. 12A In the embodiment shown, the first support structure 11 is composed of two first support units 113. Fig. 12B In the embodiment shown, the first support structure 11 is composed of three first support units 113, each of which is distributed around the urethra-vesical anastomosis section 2 and can be assembled into one by splicing to form, for example, Figure 1A and Figure 1B The first supporting structure 11 of the C-shaped structure is shown.

[0079] Furthermore, if Fig. 12C and Fig.12D In the illustrated embodiment, the first support structure 11 includes at least two first support units 113 distributed along the circumference of the urethrovesical anastomosis section 2, and a tapered groove 1131 is formed on the side wall of each first support unit 113, so that each first support unit 113 can be assembled into one piece by, for example, plugging through the tapered groove 1131, thereby forming the first support structure 11. The advantage of this embodiment is that the overall length of the first support structure 11 can be adjusted by assembling different numbers of first support units 113, thereby adapting to the actual length of the urethrovesical anastomosis section 2 of the patient.

[0080] In addition, in other embodiments, multiple implants 1 may be combined to provide overall support and protection for the urethra-vesical anastomosis section 2 of the patient. Fig.12EAs shown, in this embodiment, since the part of the urethra-vesical anastomosis section 2 adjacent to one side of the urethra is relatively narrow, the implant 1 can be first placed in this part of the urethra-vesical anastomosis section 2, and then the implant 1' can be placed in the part of the urethra-vesical anastomosis section 2 adjacent to the bladder, so that the implants 1 and 1' are combined to form an overall protection for the patient's urethra-vesical anastomosis section 2. The advantage of this embodiment is that it can facilitate the implantation operation during the operation, thereby providing greater operational flexibility.

[0081] The implantation method of the male posterior urethra resection and reconstruction surgery intraoperative implant of the present application comprises: first, after performing urethral bladder anastomosis or urethral bladder anastomosis in radical prostatectomy and radical cystectomy with intestinal replacement of in situ new bladder surgery, providing the male posterior urethra resection and reconstruction surgery intraoperative implant of the present application; and making the opening and closing structure 12 of the male posterior urethra resection and reconstruction surgery intraoperative implant 1 in an open state to open the accommodating space 1101 in the accommodating body 110; and then, setting the male posterior urethra resection and reconstruction surgery intraoperative implant 1 at the urethra 3 and bladder 4 in the patient's pelvic cavity. At the anastomosis, the patient's urethra-vesical anastomosis section is placed in the accommodating space 1101 of the accommodating body through the opening-closing structure in the open state; then, the opening-closing structure 12 is switched from the open state to the closed state by suturing or snapping, so as to completely or partially close the accommodating space 1101 in the accommodating body 110, so that the patient's urethra-vesical anastomosis section can be positioned in the accommodating space 1101, so as to replace the removed prostate with an implant during the male posterior urethra resection and reconstruction surgery, thereby providing support and shaping for the patient's urethra-vesical anastomosis section 2.

[0082] In summary, the implant during male posterior urethral resection and reconstruction surgery of the present application can prevent the internal tissue of the pelvic cavity from squeezing the urethra-bladder anastomosis section or the urethra-bladder anastomosis section of the patient. In addition, when the patient's urethra is full, it can also relieve the compression and stimulation of the urethral sphincter caused by the patient's urethra expansion, so as to provide the function of shaping, limiting expansion and maintaining the shape, thereby facilitating the recovery of urinary control and sexual function of the patient after surgery.

[0083] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the embodiments of the present application, rather than to limit them. Although the present application has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. An implant for male posterior urethral resection and reconstruction surgery, used to provide support and protection for the urethra-vesical anastomosis segment or the urethra-vesical anastomosis segment in the patient's pelvic cavity, characterized in that: The implants used in male posterior urethral resection and reconstruction surgery include: A first supporting structure having a housing body, wherein a housing space is formed inside the housing body; and An opening and closing structure is arranged on the first supporting structure; wherein, When the opening and closing structure is in an open state, the accommodation space in the accommodation body can be opened to allow the urethra-vesical anastomosis section or the urethra-vesical anastomosis section to enter the accommodation space through the opening and closing structure; When the opening and closing structure is in a closed state, the accommodation space of the accommodation body can be completely or partially closed, so that the urethra-vesical anastomosis section or the urethra-bladder anastomosis section is positioned in the accommodation space, thereby providing support and shaping for the urethra-vesical anastomosis section or the urethra-bladder anastomosis section; The implant for male posterior urethra resection and reconstruction surgery further comprises a second supporting structure, wherein the opening and closing structure is also arranged on the second supporting structure, and when the opening and closing structure is in the closed state, the second supporting structure is covered on the outside of the first supporting structure, so as to provide support and shaping for the first supporting structure and prevent the surrounding tissue in the pelvic cavity from squeezing the urethra-vesical anastomosis section or the urethra-vesical anastomosis section in the accommodating space; When the opening and closing structure is in the closed state, the outer shape of the second supporting structure matches the shape of a potential cavity formed in the pelvic cavity of the patient after the prostate of the patient is removed; The first support structure has a first hardness, and the second support structure has a second hardness, and the first hardness is greater than the second hardness.

2. The implant for male posterior urethral resection and reconstruction surgery according to claim 1, characterized in that: The housing body also has an inner wall of the housing body for defining the housing space, and the inner wall of the housing body is also covered with a first functional factor layer for providing anti-inflammatory, anti-fibrosis and promoting vascular tissue growth and repair functions for the urethra-vesical anastomosis segment or the urethra-surrogate vesical anastomosis segment.

3. The implant for male posterior urethra resection and reconstruction surgery according to claim 1, characterized in that: When the opening and closing structure is in the closed state, the outer shape of the second supporting structure is an inverted cone.

4. The implant for male posterior urethra resection and reconstruction surgery according to claim 1, characterized in that: The second support structure also has an outer side wall, and a second functional factor layer on the outer side wall, which is used to guide the growth and repair of the prostate peri-nerve bundle in the pelvic cavity, and / or to provide anti-fibrosis, anti-inflammatory, and vascular tissue growth and repair functions for the surrounding tissues in the pelvic cavity.

5. The implant for male posterior urethra resection and reconstruction surgery according to claim 4, characterized in that: The second functional factor layer is constructed of degradable materials or non-degradable materials.

6. The implant for male posterior urethra resection and reconstruction surgery according to claim 1, characterized in that: The implant for male posterior urethra resection and reconstruction surgery also has a transition structure, which is sandwiched between the first supporting structure and the second supporting structure.

7. The implant for male posterior urethra resection and reconstruction surgery according to claim 6, characterized in that: The transition structure has a third hardness, wherein the second hardness≤the third hardness≤the first hardness.

8. The implant for male posterior urethra resection and reconstruction surgery according to claim 6, characterized in that: The transition structure is a multi-layer structure.

9. The implant for male posterior urethra resection and reconstruction surgery according to claim 8, characterized in that: The hardness of the transition structure gradually decreases from an inner layer adjacent to the first supporting structure to an outer layer adjacent to the second supporting structure.

10. The implant for male posterior urethral resection and reconstruction surgery according to claim 1, characterized in that: The materials of the first supporting structure and the second supporting structure are the same or different, and the materials of the first supporting structure and the second supporting structure are selected from degradable materials, non-degradable materials, or a combination of degradable materials and non-degradable materials.

11. The implant for male posterior urethra resection and reconstruction surgery according to claim 1, characterized in that: The second supporting structure is also provided with a positioning structure, which is adapted to the neck structure of the patient's bladder or substitute bladder. By making the positioning structure and the neck of the bladder or substitute bladder fit each other, the implant can be positioned around the anastomosis between the patient's urethra and bladder or around the anastomosis between the patient's urethra and substitute bladder during the male posterior urethra resection and reconstruction surgery.

12. The implant for male posterior urethral resection and reconstruction surgery according to claim 1, characterized in that: The implant during male posterior urethra resection and reconstruction surgery also includes an auxiliary fixation device, which can be fixedly connected to the surrounding tissues or pubic bone in the pelvic cavity to provide the implant during male posterior urethra resection and reconstruction surgery to be positioned around the anastomosis between the patient's urethra and bladder or around the anastomosis between the patient's urethra and substitute bladder.

13. The implant for male posterior urethra resection and reconstruction surgery according to claim 1, characterized in that: The opening and closing structure is maintained in the closed state by sewing and / or snapping.

14. The implant for male posterior urethral resection and reconstruction surgery according to claim 1, characterized in that: The first supporting structure includes a plurality of first supporting units, wherein the first supporting units are combined with each other to form the first supporting structure.

15. The implant for male posterior urethra resection and reconstruction surgery according to claim 1, characterized in that: The volume of the space occupied by the implant in the patient's pelvic cavity during the male posterior urethra resection and reconstruction surgery is between 5 ml and 40 ml.

16. The implant for male posterior urethra resection and reconstruction surgery according to claim 15, characterized in that: The volume of the space occupied by the implant in the patient's pelvic cavity during the male posterior urethra resection and reconstruction surgery is between 10 ml and 30 ml.

17. The implant for male posterior urethra resection and reconstruction surgery according to claim 16, characterized in that: The volume of the space is 20 ml.

18. The implant for male posterior urethra resection and reconstruction surgery according to claim 15, characterized in that: The transverse diameter of the implant during the male posterior urethra resection and reconstruction surgery is between 3 cm and 6 cm, the longitudinal diameter is between 1 cm and 5 cm, and the anterior-posterior diameter is between 2 cm and 4 cm.

19. The implant for male posterior urethra resection and reconstruction surgery according to claim 18, characterized in that: The transverse diameter of the implant during male posterior urethra resection and reconstruction surgery is 4.2 cm, the longitudinal diameter is 3.2 cm, and the anterior-posterior diameter is 2.8 cm.

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