Prostate stent and implantation system

Abstract

The invention relates to the technical field of medical instruments, and discloses a prostate stent and an implantation system. The prostate stent comprises a stent body and a positioning part, the stent body comprises three cutting parts which are arranged in parallel at intervals, the far ends of every two adjacent cutting parts are connected through a front supporting part, and the near end of each cutting part is connected with a rear supporting part; one or more convex teeth are arranged on the outer side of at least one cutting part; the positioning part is used for connecting and fixing the three rear supporting parts together and can be used for positioning the implanting direction of the prostate stent. The support body is in the shape of a hollow column and can support an affected part. The convex teeth can be propped against the inner wall of an affected part, so that the prostate stent can be effectively prevented from displacing; meanwhile, an operator does not need to adjust the angle, and the operation difficulty is reduced. The positioning part can be used for positioning the implantation direction of the prostate stent while realizing connection of the stent body, so that the prostate stent is convenient to take and place.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a prostate stent and an implantation system. Background Art

[0002] In the prior art, prostate stents are usually provided with anchoring leaflets, which are pressed against the inner wall of the prostate urethra to prevent the prostate stent from migrating and entering the patient's bladder. First, the additional anchoring leaflets make the structure of the prostate stent more complicated and increase the patient's discomfort; second, during the operation, the operator needs to rotate the implant system to adjust the position of the anchoring leaflets, which increases the difficulty of the operation. In addition, most current prostate stents are provided with extraction ropes for removing the prostate stents. The provision of extraction ropes will affect the patient's daily life, reduce comfort, and even pose a risk of infection.

[0003] Therefore, there is an urgent need for a prostate stent and implantation system to solve the above problems. Summary of the invention

[0004] Based on the above, the purpose of the present invention is to provide a prostate stent and implant system with simpler structure, better comfort, greater safety and less difficulty in operation.

[0005] To achieve the above object, the present invention adopts the following technical solutions:

[0006] Prostate stents, including:

[0007] The stent body comprises three cutting parts arranged in parallel and at intervals, the distal ends of each two adjacent cutting parts are connected by a front supporting part, and the proximal end of each cutting part is connected to a rear supporting part; at least one of the cutting parts is provided with one or more convex teeth on the outer side;

[0008] The positioning part connects and fixes the three rear supporting parts together and can position the implantation direction of the prostate stent.

[0009] As a preferred solution of the prostate stent, when observed along the length direction of the cutting portion, the projections of the three front supporting portions form an isosceles triangle, and the vertex angle of the isosceles triangle ranges from 20° to 60°.

[0010] As a preferred solution of the prostate stent, the length of the cutting portion is between 2 cm and 10 cm; the length of the height perpendicular to the base of the isosceles triangle is between 1 cm and 5 cm.

[0011] As a preferred solution of the prostate stent, the positioning portion is an ellipsoid, a triangular prism, a quadrangular prism, a pentagonal prism or a hexagonal prism, and the positioning portion is located inside the isosceles triangle.

[0012] As a preferred solution of the prostate stent, the spatial position and angle of the positioning portion relative to the stent body are fixed values.

[0013] As a preferred embodiment of the prostate stent, when one convex tooth is provided on the outer side of the cutting portion, the length of the convex tooth is greater than or equal to one quarter of the length of the cutting portion; when a plurality of convex teeth are provided on the outer side of the cutting portion, when observed along the length direction of the cutting portion, relative to the extension direction of the midlines of the sides of the isosceles triangle, the plurality of convex teeth may be in the extension direction, or may be fully or partially deflected to one or both sides of the extension direction, and the deflection angle is 0-60°.

[0014] As a preferred solution of the prostate stent, along the length direction of the cutting portion, all or part of the plurality of convex teeth are inclined toward the distal end of the stent body, and the inclination angle is 0-60°.

[0015] As a preferred embodiment of the prostate stent, the shape of the convex teeth is triangle, rectangle, trapezoid, pentagon, hexagon, wave, blade or arc, and the height of the convex teeth is 1 mm-5 mm.

[0016] As a preferred solution of the prostate stent, the cutting portion, the front supporting portion and the rear supporting portion are all made of NiTi alloy, and the positioning portion is made of alloy or polymer material.

[0017] As a preferred solution of the prostate stent, the cutting portion can continuously generate a supporting force of 0.1N / cm-5N / cm outward.

[0018] As a preferred solution of the prostate stent, the cutting portion, the front supporting portion and the rear supporting portion are surface polished and / or antibacterial treated.

[0019] As a preferred solution of the prostate stent, an adhesive layer is provided on the cutting portion, and the adhesive layer includes an anti-adhesive layer directly in contact with the inner wall of the prostate and an adhesive layer located between the anti-adhesive layer and the cutting portion.

[0020] As a preferred solution of the prostate stent, the anti-adhesion layer can be naturally degraded, the adhesive layer can be naturally degraded and / or urgently released from adhesion, and the natural degradation time of the adhesive layer is greater than the natural degradation time of the anti-adhesion layer.

[0021] As a preferred solution of the prostate stent, the anti-adhesion layer does not adhere to the inner wall of the prostate and can slide relatively; the adhesive layer can adhere to the inner wall of the prostate and will not slide relatively after adhesion.

[0022] As a preferred embodiment of the prostate stent, the adhesion between the adhesive layer and the inner wall of the prostate occurs after the natural degradation of the anti-adhesive layer is completed, and the adhesive layer directly contacts and adheres to the inner wall of the prostate.

[0023] As a preferred solution of the prostate stent, the adhesion layer is arranged on part or all of the outer side of the cutting portion.

[0024] As a preferred solution of the prostate stent, the adhesive layer includes a temperature-sensitive polymer, which can lose its adhesion to the inner wall of the prostate at a set temperature.

[0025] As a preferred solution of the prostate stent, the emergency release method of the adhesive layer is: introducing an aqueous solution of a set temperature into the prostate to make the adhesive layer lose its viscosity.

[0026] As a preferred embodiment of the prostate stent, the natural degradation time of the anti-adhesive layer is 1 hour to 1 day, and the natural degradation time of the adhesive layer is 1 day to 1 month.

[0027] As a preferred embodiment of the prostate stent, the adhesion force between the adhesive layer and the inner wall of the prostate is 0.05 N / cm to 0.5 N / cm.

[0028] As a preferred solution of the prostate stent, the front support portion is formed by connecting at least two sections of straight metal wires, or by connecting one or more curved metal wires, or by connecting a curved metal wire and a straight metal wire.

[0029] An implantation system is used to implant a prostate stent as described in any of the above schemes.

[0030] As a preferred embodiment of the implant system, the implant system includes an implant rod, one end of which is configured as a clamping end, the clamping end including two clamping arms that can be relatively opened and snapped together, a positioning groove that matches the shape of the positioning part is provided inside the clamping arm, and the two clamping arms can clamp and fix the positioning part after being snapped together.

[0031] As a preferred solution of the implant system, the implant system is further provided with a drive assembly and a handle, the drive assembly is used to drive the clamping arm to open and close, and the handle is arranged at one end of the implant rod away from the clamping end.

[0032] As a preferred solution of the implant system, the implant system also includes an outer sleeve and a handle, the outer sleeve and the handle are slidably mounted on the outside of the implant rod, and the handle is fixed on the outer sleeve and can drive the outer sleeve to slide on the implant rod.

[0033] As a preferred embodiment of the implant system, the prostate stent has a compressed state in which the three cutting portions are close to each other and an expanded state in which the three cutting portions are away from each other. The prostate stent can be placed in the outer sleeve in the compressed state, and when the handle drives the outer sleeve to slide toward the handle, the prostate stent gradually returns to the expanded state.

[0034] As a preferred solution of the implant system, the positioning portion is placed in the positioning groove of the clamping arm, and the clamping arm is driven by the driving assembly to buckle and fix the positioning portion. When the outer sleeve is driven by the handle to slide away from the handle, the prostate stent is gradually compressed by the outer sleeve to the compressed state.

[0035] The beneficial effects of the present invention are:

[0036] The present invention provides a front support part, a cutting part and a rear support part which are interconnected, and the three cutting parts are arranged in parallel and spaced apart, and the front end and the rear end are respectively connected by the front support part and the rear support part, that is, the stent body is in a hollow columnar shape, which can support the affected part to achieve the purpose of treatment. Specifically, the cutting part is provided with convex teeth, so that after the prostate stent is placed in the human body, the convex teeth can abut against the inner wall of the affected part, which can effectively prevent the displacement of the prostate stent, ensure the reliable support of the prostate stent to the affected part, and the structure is simpler; at the same time, since each cutting part is provided with convex teeth, there is no need for the operator to adjust the angle, which reduces the difficulty of operation. By providing a positioning part, while realizing the connection of the stent body, the implantation direction of the prostate stent can also be positioned, which is convenient for taking and placing the prostate stent, and will not affect the daily life of the patient, with higher comfort and safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments of the present invention. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the contents of the embodiments of the present invention and these drawings without paying any creative work.

[0038] Figure 1 is a schematic diagram of a prostate stent provided in a specific embodiment of the present invention;

[0039] Figure 2 is a projection view of a prostate stent provided in a specific embodiment of the present invention;

[0040] Figure 3 is a schematic diagram of an implant rod of an implant system provided in a specific embodiment of the present invention;

[0041] Figure 4 yes Figure 3 An enlarged schematic diagram of the clamping end;

[0042] Figure 5 is a schematic diagram of an implant system provided by a specific embodiment of the present invention being coupled to a prostate stent, and the prostate stent being placed in an expanded state;

[0043] Figure 6 is a perspective view of an implant system provided by a specific embodiment of the present invention being coupled to a prostate stent, and the prostate stent being placed in a compressed state;

[0044] Figure 7 yes Figure 6 A partially enlarged schematic diagram of .

[0045] In the figure:

[0046] 1. Cutting part; 12. Convex teeth; 2. Rear support part; 3. Positioning part; 4. Front support part; 5. Clamping arm; 6. Implant rod; 7. Drive assembly; 8. Handle; 9. Positioning groove; 10. Outer sleeve; 11. Handle. DETAILED DESCRIPTION

[0047] The embodiments of the present invention are described in detail below, and examples of the embodiments are shown in the accompanying drawings. The embodiments described below with reference to the accompanying drawings are exemplary and intended to be used to explain the present invention, but should not be understood as limiting the present invention.

[0048] The technical solution of the present invention is further described below with reference to the accompanying drawings and through specific implementation methods.

[0049] like Figure 1-Figure 5 As shown, this embodiment provides a prostate stent, which includes a stent body and a positioning portion 3, the stent body includes three cutting portions 1 arranged in parallel and spaced apart, the distal ends of each two adjacent cutting portions 1 are connected by a front supporting portion 4, and the proximal end of each cutting portion 1 is connected to a rear supporting portion 2; at least one cutting portion 1 is provided with one or more convex teeth 12 on the outer side; the positioning portion 3 connects and fixes the three rear supporting portions 2 together and can position the implantation direction of the prostate stent.

[0050] By setting up the front support part 4, the cutting part 1 and the rear support part 2 which are connected to each other, and the three cutting parts 1 are arranged in parallel and spaced apart, and the front end and the rear end are respectively connected by the front support part 4 and the rear support part 2, that is, the stent body is in the shape of a hollow column, which can realize the support of the affected part to achieve the purpose of treatment. Specifically, the cutting part 1 is provided with a convex tooth 12, so that after the prostate stent is placed in the human body, the convex tooth 12 can abut against the inner wall of the affected part, which can effectively prevent the displacement of the prostate stent, ensure the reliable support of the prostate stent to the affected part, and the structure is simpler and more comfortable; at the same time, since each cutting part 1 is provided with a convex tooth 12, there is no need for the operator to adjust the angle, which reduces the difficulty of operation. By setting up the positioning part 3, while realizing the connection of the stent body, it can also make the process of placing the stent easier and reduce the difficulty of operation.

[0051] It can be understood that the distal end and the front end are both ends close to the patient, and the proximal end and the rear end are both ends close to the operator. In other embodiments, a convex tooth 12 can be provided on one of the cutting parts 1, a convex tooth 12 can be provided on any two of the cutting parts 1, and a convex tooth 12 can be provided on all three cutting parts 1. The convex teeth 12 can be provided as one or more, wherein the plurality can be two, three, four, five or more. Or the number of convex teeth 12 on the three cutting parts 1 can be provided as different, such as no convex tooth 12 is provided on one of the cutting parts 1, one convex tooth 12 is provided on one of the cutting parts 1, and a plurality of convex teeth 12 are provided on the other cutting part 1.

[0052] In this embodiment, the front support portion 4 is formed by connecting at least two straight metal wires, or by connecting one or more curved metal wires, or by connecting a curved metal wire and a straight metal wire. The above arrangement allows a bulge to be generated between the connecting lines of the two distal ends of the adjacent cutting portions when the stent body is compressed, facilitating the bending of the stent body when the outer sleeve 10 is compressed until the stent body enters the outer sleeve 10. It can be understood that the bulge is the bending point that is bent.

[0053] Specifically, when viewed along the length direction of the cutting portion 1, the projections of the three front supporting portions 4 form an isosceles triangle, and the projections of the three cutting portions 1 extend along the angle bisector of the isosceles triangle. The vertex angle of the isosceles triangle ranges from 20° to 60°, and optionally, the vertex angle of the isosceles triangle is set to 20°, 25°, 30°, 35°, 40°, 45°, 50°, 55° or 60°.

[0054] Exemplarily, the length of the cutting portion 1 is between 2cm and 10cm to ensure the effective support length for the affected part, and can be set to 2cm, 4cm, 6cm, 8cm or 10cm; the length of the height perpendicular to the base of the isosceles triangle is between 1cm and 5cm to ensure that the inner diameter of the hollow column can meet the support distance, and can be set to 1cm, 2cm, 3cm, 4cm or 5cm. Further, the cutting portion 1 can continuously generate a support force of 0.1N / cm-5N / cm outward to provide reliable and stable support for the affected part, and can be set to 0.1N / cm, 1N / cm, 1.5N / cm, 2N / cm, 2.5N / cm, 3N / cm, 3.5N / cm, 4N / cm, 4.5N / cm or 5N / cm.

[0055] Optionally, the shape of the convex teeth 12 can be triangular, rectangular, trapezoidal, pentagonal, hexagonal, wavy, blade-shaped or arc-shaped. The specific shape of the convex teeth 12 can be set by those skilled in the art according to actual needs, as long as the relative migration between the cutting portion 1 and the inner wall of the affected part can be reduced. The height of the convex teeth 12 is 1mm-5mm, and can be set to 1mm, 2mm, 3mm, 4mm or 5mm, which can reduce the relative displacement without causing damage to the inner wall of the affected part.

[0056] It is worth noting that when a convex tooth 12 is provided on the outside of the cutting portion 1, the length of the convex tooth 12 is greater than or equal to one quarter of the length of the cutting portion 1 to ensure a more reliable fit with the inner wall of the affected part. When multiple convex teeth 12 are provided on the outside of the cutting portion 1, when observed along the length direction of the cutting portion 1, relative to the extension direction of the midlines of the sides of the isosceles triangle, the multiple convex teeth 12 can be in the extension direction to improve the anti-migration effect, or they can be fully or partially deflected to one or both sides of the extension direction to reduce damage to the inner wall of the affected part. Optionally, the deflection angle is 0-60°. It is understandable that a too large deflection angle will reduce the anti-migration effect. For example, it can be set to 0°, 10°, 20°, 30°, 40°, 50° or 60°.

[0057] Furthermore, along the length direction of the cutting portion 1, all or part of the multiple convex teeth 12 are inclined toward the distal end of the stent body, and the inclination angle is 0-60°, providing greater resistance to the migration of the prostate stent toward the bladder, so as to avoid the migration of the prostate stent and enter the patient's bladder, thereby improving the safety of the use of the prostate stent. Exemplary settings can be 0°, 10°, 20°, 30°, 40°, 50° or 60°.

[0058] In this embodiment, the positioning part 3 is an ellipsoid, a triangular prism, a quadrangular prism, a pentagonal prism or a hexagonal prism, and the positioning part 3 is located inside the isosceles triangle to ensure a more reliable connection to the stent body. Furthermore, the spatial position and angle of the positioning part 3 relative to the stent body are fixed values, so that when implanting the prostate stent, the operator can place the prostate stent in the correct position according to the positioning part 3 corresponding to the three angles of the stent body, without adjustment, or only fine-tuning, reducing the operating steps during release, thereby reducing the difficulty of the release operation. For example, the length direction of one of the three cutting parts 1 can be set to the midline position of the long axis or the midline position of the short axis of the positioning part 3 of the corresponding ellipsoid; or the length direction of one of the three cutting parts 1 can be set to be in the same straight line with the direction of one of the prisms in the positioning part 3 of the triangular prism; or the length direction of one of the three cutting parts 1 can be set to be in the same straight line with the direction of one of the prisms in the positioning part 3 of the quadrangular prism; or the length direction of one of the three cutting parts 1 can be set to be in the same straight line with the direction of one of the prisms in the positioning part 3 of the pentagonal prism; or the length direction of one of the three cutting parts 1 can be set to be in the same straight line with the direction of one of the prisms in the positioning part 3 of the hexagonal prism. It can be understood that the prismatic positioning part 3 is convenient for the operator to observe the relative position relationship between it and the cutting part 1 of the bracket body. In other embodiments, the positioning part 3 can also be set to a spherical shape. In order to facilitate the observation of the relative position relationship between the spherical positioning part 3 and the cutting part 1 of the bracket body, a corresponding mark can be set on the spherical positioning part 3.

[0059] In this embodiment, the cutting part 1, the front support part 4 and the rear support part 2 are all made of NiTi alloy, which is in a superelastic state at human body temperature and has more stable physical and chemical properties. The positioning part 3 is made of alloy, polymer material or a combination thereof, which has better strength. For example, it can be NiTi alloy, stainless steel, PTFE, TPU, PP, PE, etc.

[0060] Preferably, the cutting portion 1, the front supporting portion 4 and the rear supporting portion 2 are surface polished and / or antibacterial treated to ensure that they do not adhere to the surface tissue of the prostate during the implantation period, making the implantation process smoother; at the same time, it reduces the infection of the affected area and greatly reduces the probability of stone occurrence, which is conducive to the smooth removal of the subsequent prostate stent.

[0061] As an optional solution for the prostate stent, an adhesive layer is provided on the cutting portion 1 to improve the reliability of the prostate stent and the inner wall of the prostate. The adhesive layer includes an anti-adhesive layer in direct contact with the inner wall of the prostate and an adhesive layer located between the anti-adhesive layer and the cutting portion 1. It is worth noting that the anti-adhesive layer does not adhere to the inner wall of the prostate and can slide relatively, which is used to avoid adhesion between the prostate stent and the inner wall of the prostate during the implantation process and improve the smoothness of the implantation; the adhesive layer can adhere to the inner wall of the prostate and will not slide relatively after adhesion, which is used to make the prostate stent adhere to the inner wall of the prostate after the prostate stent is implanted and not migrate, and to provide stable support. Exemplarily, the adhesion force between the adhesive layer and the inner wall of the prostate is 0.05N / cm to 0.5N / cm, which makes the bonding more reliable and avoids the migration of the prostate stent. Exemplarily, it can be set to 0.05N / cm, 0.1N / cm, 0.15N / cm, 0.2N / cm, 0.25N / cm, 0.3N / cm, 0.35N / cm, 0.44N / cm, 0.45N / cm or 0.5N / cm.

[0062] Specifically, the anti-adhesive layer can be naturally degraded, so that it can be degraded later to expose the adhesive layer, that is, the adhesion between the exposed adhesive layer and the inner wall of the prostate occurs after the natural degradation of the anti-adhesive layer is completed, and the adhesive layer directly contacts and bonds with the inner wall of the prostate.

[0063] Optionally, the adhesive layer can be naturally degraded and / or urgently released to adapt to different usage scenarios. In addition, the natural degradation time of the adhesive layer is longer than the natural degradation time of the anti-adhesive layer, so that the anti-adhesive layer will not be degraded before the adhesive layer is naturally degraded, thereby ensuring that the prostate stent is bonded to the inner wall of the prostate. Optionally, the natural degradation time of the anti-adhesive layer is 1 hour to 1 day, and the natural degradation time of the adhesive layer is 1 day to 1 month.

[0064] Optionally, the adhesive layer is disposed on part or all of the outer side of the cutting portion 1 , and those skilled in the art may configure it according to actual needs, which is not specifically limited here.

[0065] Exemplarily, the adhesive layer includes a thermosensitive polymer, which can lose its adhesiveness to the inner wall of the prostate at a set temperature. Further, the adhesive layer also includes a bioadhesive material.

[0066] It is worth noting that the adhesion of the adhesive layer to the inner wall occurs after the natural degradation of the anti-adhesive layer is completed, and the adhesive layer is in direct contact and adhesion with the inner wall. The natural degradation time of the anti-adhesive layer is set to be much shorter than the natural degradation time of the adhesive layer, leaving doctors with enough surgical operation time to place the stent at the target position in the prostate. After the natural degradation of the anti-adhesive layer is completed, the adhesive layer can be in direct contact and adhesion with the inner wall to fix the stent in place and prevent displacement.

[0067] Specifically, the bioadhesive material includes any one or a combination of at least two of N-hydroxysuccinimide, N-hydroxysuccinimide ester, cyanoacrylate, aldehyde compounds, primary amino compounds, thiol compounds, imidazole, maleamide, isocyanate, epoxy compounds or acrylate, catechol, and aromatic azide. Exemplarily, the combination of at least two is a combination of N-hydroxysuccinimide and N-hydroxysuccinimide ester, a combination of maleamide and acrylate, or a combination of N-hydroxysuccinimide ester and acrylate, etc.

[0068] Furthermore, the adhesive layer also includes a temperature-sensitive polymer, which can make the adhesive force between the adhesive layer and the inner wall disappear when a set temperature aqueous solution is passed in. By providing the temperature-sensitive polymer in the adhesive layer, when it is necessary to urgently release the adhesive force of the adhesive layer, a set temperature aqueous solution can be passed into the prostate to make the adhesive force between the adhesive layer and the inner wall of the cavity disappear.

[0069] Regarding the thermosensitive polymer, when the temperature is lower than the transition temperature (LCST) of the thermosensitive polymer, the hydrophilic groups in the thermosensitive polymer molecules play a dominant role, and the hydrophilic groups form hydrogen bonds with water molecules to form a dense hydration shell structure, so that the thermosensitive polymer presents an extended "coil" state, and the thermosensitive polymer is soluble at this time. The thermosensitive polymer exhibits a cloud point (CP) or a lower critical solution temperature (LCST) in an aqueous solution. The water-soluble thermosensitive polymer is selected to produce a low viscosity liquid when dissolved in water at low temperatures. Raising the temperature above the gelation temperature (T gel) will cause the composition to solidify. The thermosensitive polymer is an ABA triblock structure, wherein A is a hydrophilic oligomer and B is a hydrophobic oligomer; or A is a hydrophobic oligomer and B is a hydrophilic oligomer; or A and B contain aliphatic polyether and / or polyester units; or A is poly (ethylene oxide) and B is poly (propylene oxide). The thermosensitive polymer is poly (N-substituted (meth) acrylamide). The poly(N-substituted (meth)acrylamide) is poly(N-isopropyl (meth)acrylamide). The thermosensitive polymer is hydroxypropyl methylcellulose, ethyl hydroxyethyl cellulose (EHEC) or any combination thereof. The thermosensitive polymer is a multi-block (ABA-X)m random or repeating structure, wherein m is an integer from 1 to 30, and X is a chain extender. X is selected from di-, tri- and polyisocyanates, di-, tri- and polycarboxylic acids, diacyl halides, triphosgene or any combination thereof. A is a hydrophilic oligomer and B is a hydrophobic oligomer; or, A is a hydrophobic oligomer and B is a hydrophilic oligomer. The multi-block structure is polyurethane, polycarbonate, polyester or any combination thereof, and the transition can occur at as low as 30°C-40°C. Poly(N-isopropylacrylamide) [poly(NIPAM)] shows a lower critical solution temperature (LCST) at about 31°C in aqueous solution. Poly(NIPAM) gel undergoes a volume phase transition from a swollen gel to a shrunk gel at about 33.6°C in water. First, the thermosensitive copolymer synthesized from the hydrophilic monomer and the thermosensitive polymer monomer shrinks by being sensitive to temperature (human body temperature 36.5°C). Increasing the amount of hydrophilic monomer can increase the transition temperature of the formed thermosensitive copolymer. Therefore, for thermosensitive polymer monomers with a very high transition temperature (such as N-isopropylacrylamide), the amount of hydrophilic monomer should not be too large. For thermosensitive polymer monomers with a lower transition temperature (such as 2-methyl-2-acrylic acid-2-(2-methoxyethoxy)ethyl ester), the transition temperature of the formed polymer can be increased by increasing the amount of hydrophilic polymer monomer.

[0070] The set temperature is not specifically limited here, and those skilled in the art can set it according to the transition temperature of the thermosensitive polymer. The aqueous solution can be physiological saline or purified water.

[0071] The anti-adhesion layer does not adhere to the inner wall of the prostate, so that the stent can move to the target position in the cavity. The anti-adhesion layer delays the release of the adhesive layer, providing doctors with time to operate and avoiding the stent from adhering to the inner wall of the prostate before the implantation operation is completed; or when the stent is in the shelf life, the stent is folded and squeezed to prevent the adhesive layer of the stent from self-adhering and causing the stent to fail. During the implantation process of the prostate, the anti-adhesion layer can also ensure that the stent can move in the prostate, allowing doctors to implant the stent in the target position of the prostate.

[0072] The surface of the anti-adhesive layer can be a smooth surface or a concave-convex surface with a certain friction force, as long as it does not affect the relative movement of the stent relative to the wall of the cavity. The anti-adhesive layer includes a degradable material, and the degradable material can be selected from: PLGA (poly(lactic-co-glycolic acid), polylactic acid-glycolic acid copolymer), hyaluronic acid, deacetylated chitosan, quaternized chitosan, carboxymethyl chitosan, type I collagen, carboxymethyl chitosan, regenerated oxidized cellulose, dextran, starch, collagen and gelatin. The anti-adhesive layer can select one or more of the above-mentioned degradable materials.

[0073] Furthermore, the emergency release method of the adhesive layer is: introducing a water solution at a set temperature into the prostate to make the adhesive layer lose its viscosity. When release is needed, it can be achieved by introducing a water solution at a set temperature, and the release operation is simple and the release effect is good.

[0074] This embodiment also discloses an implantation system for implanting the prostate stent as described in any of the above schemes. The implantation system can shrink the prostate stent, then implant the shrunken prostate stent into the affected area and release it, and can also shrink and remove the prostate stent placed in the affected area.

[0075] Specifically, to achieve the connection between the implant system and the prostate stent, the implant system includes an implant rod 6, one end of the implant rod 6 is set as a clamping end, the clamping end includes two clamping arms 5 that can be relatively opened and buckled, and the clamping arm 5 is provided with a positioning groove 9 that matches the shape of the positioning part 3. When the positioning part 3 is placed between the two clamping arms 5, the two clamping arms 5 are buckled with each other to clamp and fix the positioning part 3, thereby achieving the connection between the implant system and the prostate stent. It can be understood that the size of the positioning groove 9 is not less than the size of the positioning part 3.

[0076] Further, the implant system is also provided with a drive assembly 7 and a handle 8, the handle 8 is provided at one end of the implant rod 6 away from the clamping end, and the drive assembly 7 is used to drive the clamping arm 5 to open and close. For ease of operation, the drive assembly 7 is provided with an operation button, and the operator can control the drive assembly 7 through the operation button. The operation button is provided on the handle 8, which is convenient for the operator to operate. Optionally, the operator can press the operation button to realize the opening or closing operation of the clamping arm 5 relative to the implant rod 6.

[0077] Preferably, the implantation system further comprises an outer sleeve 10 and a handle 11, the outer sleeve 10 and the handle 11 are slidably sleeved on the outside of the implantation rod 6, and the handle 11 is fixed on the outer sleeve 10, so that the operator can drive the handle 11 to drive the outer sleeve 10 to slide on the implantation rod 6, and the operation is more convenient. Among them, the prostate stent has a compressed state and an expanded state. When placed in the compressed state, the front support part 4 and the rear support part 2 are in a compressed state, and the three cutting parts 1 are close to each other; when placed in the expanded state, the front support part 4 and the rear support part 2 are in a natural state, and the three cutting parts 1 are far away from each other. It can be understood that the outer sleeve 10 can drive the prostate stent to be placed in a compressed state, at which time the outer diameter of the prostate stent is small and is located in the outer sleeve 10, which is used for implantation and removal operations; when the prostate stent is out of the outer sleeve 10, it can be restored to the expanded state, and at this time it can be used to support the affected area.

[0078] When in use, first, the positioning portion 3 of the prostate stent is placed in the positioning groove 9 of the clamping arm 5, and the clamping arm 5 is driven by the driving assembly 7 to clamp and fix the positioning portion 3, and then the outer sleeve 10 is driven by the handle 11 to slide away from the handle 8, and the prostate stent is gradually compressed by the outer sleeve 10 to a compressed state and is received in the outer sleeve 10. At this time, the prostate stent is in a compressed state and completely placed in the outer sleeve 10, which is convenient for implantation operation; after the compressed prostate stent is implanted into the affected part, the implantation system is kept as immobile as possible, and the outer sleeve 10 is driven by the handle 11 to slide toward the handle 8. The prostate stent gradually breaks away from the outer sleeve 10, and under the action of its elastic restoring force, it is restored from the compressed state to the expanded state to support the affected part, providing outward compression to the prostate tissue, and generating an incision in the inner wall tissue of the prostate, thereby alleviating prostate hypertrophy. At this time, if the position of the prostate stent needs to be adjusted, it can be adjusted by rotating the implantation system, and after adjustment, the clamping arm 5 is driven to open to disconnect from the positioning portion 3, and then the implantation system can be taken out.

[0079] After the prostate stent is placed for a period of time, an incision has been formed in the inner wall tissue of the prostate, and prostate hypertrophy is relieved. When the prostate stent needs to be removed from the affected area, under the action of the cystoscope, first insert one end of the implant system with the clamping arm 5 into the prostate, and move it to the vicinity of the affected area, then expose the clamping arm 5, press the operation button, open the clamping arm 5 relative to the implant rod 6, find the positioning part 3 under the cystoscope, and press the operation button again to make the clamping arm 5 relative to the implant rod 6 and clamp the positioning part 3. Keep the outer sleeve 10 as still as possible, pull the handle 8 toward the side close to the operator, move the implant rod 6, and then gradually shrink the prostate stent into the outer sleeve 10. When the prostate stent is completely placed in the outer sleeve 10, ensure that the outer sleeve 10 and the implant rod 6 are relatively still and gradually move the implant system and the prostate stent out of the body. At this time, the prostate stent is removed.

[0080] The above contents are only preferred embodiments of the present invention. For ordinary technicians in this field, according to the concept of the present invention, there will be changes in the specific implementation methods and application scopes. The content of this specification should not be understood as limiting the present invention.

Claims

1. A prostate stent, characterized in that: include: The stent body comprises three cutting portions (1) arranged in parallel and at intervals, the distal ends of each two adjacent cutting portions (1) are connected by a front supporting portion (4), and the proximal end of each cutting portion (1) is connected to a rear supporting portion (2); at least one of the cutting portions (1) is provided with one or more convex teeth (12) on its outer side; The positioning part (3) connects and fixes the three rear supporting parts (2) together and can position the implantation direction of the prostate stent.

2. The prostate stent according to claim 1, characterized in that: When observed along the length direction of the cutting portion (1), the projections of the three front supporting portions (4) form an isosceles triangle, and the vertex angle of the isosceles triangle ranges from 20° to 60°.

3. The prostate stent according to claim 2, characterized in that: The length of the cutting portion (1) is between 2 cm and 10 cm; the length of the height perpendicular to the base of the isosceles triangle is between 1 cm and 5 cm.

4. The prostate stent according to claim 2, characterized in that: The positioning portion (3) is an ellipsoid, a triangular prism, a quadrangular prism, a pentagonal prism or a hexagonal prism, and the positioning portion (3) is located inside the isosceles triangle.

5. The prostate stent according to claim 4, characterized in that: The spatial position and angle of the positioning portion (3) relative to the bracket body are fixed values.

6. The prostate stent according to claim 2, characterized in that: When one convex tooth (12) is provided on the outer side of the cutting portion (1), the length of the convex tooth (12) is greater than or equal to one quarter of the length of the cutting portion (1); when a plurality of convex teeth (12) are provided on the outer side of the cutting portion (1), when observed along the length direction of the cutting portion (1), relative to the extension direction of the midlines of the sides of the isosceles triangle, the plurality of convex teeth (12) may be in the extension direction, or may be fully or partially deflected to one or both sides of the extension direction, and the deflection angle is 0-60°.

7. The prostate stent according to claim 1 or 6, characterized in that: Along the length direction of the cutting portion (1), all or part of the plurality of protruding teeth (12) are inclined toward the distal end of the stent body, and the inclination angle is 0-60°.

8. The prostate stent according to claim 1, characterized in that: The shape of the convex teeth (12) is triangle, rectangle, trapezoid, pentagon, hexagon, wave, blade or arc, and the height of the convex teeth (12) is 1 mm-5 mm.

9. The prostate stent according to claim 1, characterized in that: The cutting portion (1), the front supporting portion (4) and the rear supporting portion (2) are all made of NiTi alloy, and the positioning portion (3) is made of alloy, polymer material or a combination thereof.

10. The prostate stent according to claim 1, characterized in that: The cutting portion (1) can continuously generate a supporting force of 0.1N / cm-5N / cm outwards.

11. The prostate stent according to claim 1, characterized in that: The cutting portion (1), the front supporting portion (4) and the rear supporting portion (2) are subjected to surface polishing and / or antibacterial treatment.

12. The prostate stent according to claim 1, characterized in that: The cutting portion (1) is provided with an adhesive layer, the adhesive layer comprising an anti-adhesive layer in direct contact with the inner wall of the prostate and an adhesive layer located between the anti-adhesive layer and the cutting portion (1).

13. The prostate stent according to claim 12, characterized in that: The release layer can be naturally degraded, the adhesive layer can be naturally degraded and / or urgently released from adhesion, and the natural degradation time of the adhesive layer is longer than the natural degradation time of the release layer.

14. The prostate stent according to claim 12, characterized in that: The anti-adhesion layer does not adhere to the inner wall of the prostate and can slide relatively; the adhesive layer can adhere to the inner wall of the prostate and will not slide relatively after adhesion.

15. The prostate stent according to claim 13, characterized in that: The adhesion between the adhesive layer and the inner wall of the prostate occurs after the natural degradation of the anti-adhesive layer is completed, and the adhesive layer directly contacts and adheres to the inner wall of the prostate.

16. The prostate stent according to claim 12, characterized in that: The adhesive layer is arranged on part or all of the outer side of the cutting portion (1).

17. The prostate stent according to claim 13, characterized in that: The adhesive layer includes a temperature-sensitive polymer, which can lose its adhesion to the inner wall of the prostate at a set temperature.

18. The prostate stent according to claim 17, characterized in that: The emergency release method of the adhesive layer is: introducing a water solution of a set temperature into the prostate to make the adhesive layer lose its viscosity.

19. The prostate stent according to claim 13, characterized in that: The natural degradation time of the anti-adhesive layer is 1 hour to 1 day, and the natural degradation time of the adhesive layer is 1 day to 1 month.

20. The prostate stent according to any one of claims 12 to 14, characterized in that: The adhesion between the adhesive layer and the inner wall of the prostate is 0.05N / cm to 0.5N / cm.

21. The prostate stent according to claim 1, characterized in that: The front support part (4) is formed by connecting at least two sections of straight metal wires, or by connecting one or more curved metal wires, or by connecting a curved metal wire and a straight metal wire.

22. An implant system, characterized in that Used for implanting a prostate stent as described in any one of claims 1-21.

23. The implant system according to claim 22, characterized in that The implantation system comprises an implantation rod (6), one end of which is arranged as a clamping end, and the clamping end comprises two clamping arms (5) which can be relatively opened and snapped together, and a positioning groove (9) which matches the shape of the positioning part (3) is arranged inside the clamping arm (5), and the two clamping arms (5) can clamp and fix the positioning part (3) after being snapped together.

24. The implant system according to claim 23, characterized in that The implant system is also provided with a drive assembly (7) and a handle (8), wherein the drive assembly (7) is used to drive the clamping arm (5) to open and close, and the handle (8) is arranged at one end of the implant rod (6) away from the clamping end.

25. The implant system according to claim 23 or 24, characterized in that The implant system further comprises an outer sleeve (10) and a handle (11), wherein the outer sleeve (10) and the handle (11) are slidably mounted on the outside of the implant rod (6), and the handle (11) is fixed on the outer sleeve (10) and can drive the outer sleeve (10) to slide on the implant rod (6).

26. The implant system according to claim 25, characterized in that The prostate stent has a compressed state in which the three cutting portions (1) are close to each other and an expanded state in which the three cutting portions (1) are away from each other. The prostate stent can be placed in the outer sleeve (10) in the compressed state, and when the handle (11) drives the outer sleeve (10) to slide in the direction of the handle (8), the prostate stent gradually returns to the expanded state.

27. The implant system according to claim 25, characterized in that The positioning portion (3) is placed in the positioning groove (9) of the clamping arm (5), and the clamping arm (5) is driven by the driving component (7) to snap and fix the positioning portion (3). When the outer sleeve (10) is driven by the handle (11) to slide away from the handle (8), the prostate stent is gradually compressed by the outer sleeve (10) to the compressed state.

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