Prostate stent and implantation system
By designing a prostate stent with protruding teeth and positioning parts, and combining NiTi alloy and polymer materials, the problems of complex structure and low comfort of existing stents have been solved, achieving a simple, safe and reliable support effect.
Patent Information
- Application Number
- CN202422403448.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-30
- Publication Date
- 2025-11-11
- Estimated Expiration
- 2034-09-30
AI Technical Summary
Existing prostate stents have complex structures due to the anchoring lobes, which increases patient discomfort and operational difficulty. Furthermore, the retrieval rope affects comfort and poses a risk of infection.
A prostate stent is designed, comprising parallel spaced cutting sections and support sections, with protruding teeth to prevent displacement and positioning via a positioning section. It employs NiTi alloy and polymer materials, combined with an adhesive layer and a temperature-sensitive polymer to improve comfort and safety.
This invention achieves a prostate stent that is simple in structure, easy to operate, comfortable, and safe, reducing patient discomfort and infection risk, and ensuring reliable support and positioning of the stent.
Smart Images
Figure CN223529590U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, and in particular to a prostate stent and implantation system. Background Technology
[0002] In existing technologies, prostate stents typically include an anchoring lobule that rests against the inner wall of the prostatic urethra to prevent migration and entry into the bladder. Firstly, the additional anchoring lobule complicates the stent's structure and increases patient discomfort. Secondly, during procedure, the operator needs to rotate the implantation system to adjust the position of the anchoring lobule, increasing the difficulty of the procedure. Furthermore, most current prostate stents include a retrieval rope for removal, which can disrupt 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. Utility Model Content
[0004] Based on the above, the purpose of this utility model is to provide a prostate stent and implantation system that has a simpler structure, better comfort, greater safety, and easier operation.
[0005] To achieve the above objectives, the present invention adopts the following technical solution:
[0006] Prostate stents, including:
[0007] The support body includes three parallel and spaced-apart cutting sections, with the distal ends of every two adjacent cutting sections connected by a front support section and the proximal end of each cutting section connected by a rear support section; at least one cutting section has one or more protruding teeth on its outer side.
[0008] The positioning part connects and fixes the three rear support parts together and can position the implantation direction of the prostate stent.
[0009] As a preferred embodiment of the prostate stent, when viewed along the length of the cut portion, the projections of the three anterior support portions form an isosceles triangle, with the vertex angle of the isosceles triangle ranging from 20° to 60°.
[0010] As a preferred embodiment of the prostate stent, the length of the cutting portion is 2cm-10cm; the length of the height perpendicular to the base of the isosceles triangle is 1cm-5cm.
[0011] As a preferred embodiment of the prostate stent, the positioning part is an ellipsoid, a triangular prism, a quadrangular prism, a pentagonal prism, or a hexagonal prism, and the positioning part is located inside the isosceles triangle.
[0012] In a preferred embodiment of a prostate stent, the spatial position and angle of the positioning part relative to the stent body are fixed.
[0013] As a preferred embodiment of the prostate stent, when one of the protruding teeth is provided on the outer side of the cutting portion, the length of the protruding tooth is greater than or equal to one-quarter of the length of the cutting portion; when multiple protruding teeth are provided on the outer side of the cutting portion, when viewed along the length direction of the cutting portion, relative to the extension direction of the median of each side of the isosceles triangle, the multiple protruding teeth may be located in the extension direction, or may be deflected to one or both sides of the extension direction, with a deflection angle of 0-60°.
[0014] As a preferred embodiment of the prostate stent, along the length of the cut portion, all or part of the plurality of protruding teeth are inclined toward the distal end of the stent body, with an inclination angle of 0-60°.
[0015] As a preferred embodiment of the prostate stent, the protrusion teeth are triangular, rectangular, trapezoidal, pentagonal, hexagonal, wavy, leaf-shaped, or arc-shaped, and the height of the protrusion teeth is 1mm-5mm.
[0016] As a preferred embodiment of the prostate stent, the cutting part, the anterior support part, and the posterior support part are all made of NiTi alloy, and the positioning part is made of alloy or polymer material.
[0017] As a preferred embodiment of the prostate stent, the cutting portion can continuously generate a supporting force of 0.1 N / cm to 5 N / cm outward.
[0018] As a preferred embodiment of the prostate stent, the cutting portion, the anterior support portion, and the posterior support portion are surface-polished and / or antibacterial treated.
[0019] As a preferred embodiment of the prostate stent, the cutting portion is provided with an adhesive layer, the adhesive layer including an anti-adhesion layer that is in direct contact with the inner wall of the prostate and an adhesive layer located between the anti-adhesion layer and the cutting portion.
[0020] As a preferred embodiment of the prostate stent, the anti-adhesion layer is biodegradable, the adhesive layer is biodegradable and / or capable of emergency release from adhesion, and the biodegradation time of the adhesive layer is longer than that of the anti-adhesion layer.
[0021] As a preferred embodiment of the prostate stent, the anti-adhesion layer does not adhere to the inner wall of the prostate and can slide relative to it; the adhesive layer can adhere to the inner wall of the prostate and will not slide relative to it after adhesion.
[0022] In a preferred embodiment of a prostate stent, the adhesion between the adhesive layer and the inner wall of the prostate occurs after the anti-adhesion layer has naturally degraded, and the adhesive layer directly contacts and adheres to the inner wall of the prostate.
[0023] As a preferred embodiment of the prostate stent, the adhesive layer is disposed partially or entirely on the outer side of the cutting portion.
[0024] As a preferred embodiment of the prostate stent, the adhesive layer comprises a thermosensitive polymer that loses its adhesion to the inner wall of the prostate at a set temperature.
[0025] As a preferred embodiment of the prostate stent, the emergency method for releasing the adhesive layer is to introduce an aqueous solution at a set temperature into the prostate, causing the adhesive layer to lose its adhesiveness.
[0026] As a preferred embodiment of the prostate stent, the natural degradation time of the anti-adhesion 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 embodiment of the prostate stent, the anterior support portion is composed of at least two straight metal wires connected together, or one or more curved metal wires connected together, or a combination of curved metal wires and straight metal wires connected together.
[0029] An implantation system for implanting a prostate stent as described in any of the above protocols.
[0030] As a preferred embodiment of the implantation system, the implantation system includes an implantation rod, one end of which is configured as a clamping end. The clamping end includes two clamping arms that can be opened and closed relative to each other. The clamping arms are provided with positioning grooves that match the shape of the positioning part. When the two clamping arms are closed together, they can clamp and fix the positioning part.
[0031] As a preferred embodiment of the implantation system, the implantation system is further provided with a drive assembly and a handle, the drive assembly being used to drive the clamping arm to open and close, and the handle being located at the end of the implantation rod away from the clamping end.
[0032] As a preferred embodiment of the implantation system, the implantation system further includes an outer sleeve and a handle, the outer sleeve and the handle being slidably fitted onto the outside of the implantation rod, the handle being fixed to the outer sleeve and capable of driving the outer sleeve to slide on the implantation rod.
[0033] As a preferred embodiment of the implantation system, the prostate stent has a compressed state in which three cutting portions are close to each other and an expanded state in which three cutting portions are far apart. The prostate stent can be placed inside the outer sheath in the compressed state, and as the outer sheath slides towards the handle with the pull handle, the prostate stent gradually returns to the expanded state.
[0034] As a preferred embodiment of the implantation system, the positioning part is placed in the positioning groove of the clamping arm, and the clamping arm is driven by the driving component to fasten and fix the positioning part. When the outer tube is slid away from the handle by the pull handle, the prostate stent is gradually compressed to the compressed state by the outer tube.
[0035] The beneficial effects of this utility model are as follows:
[0036] This invention features interconnected front support, cutting sections, and rear support sections, with the three cutting sections arranged parallel and spaced apart. The front and rear ends are connected via the front and rear support sections, respectively, resulting in a hollow cylindrical stent body that provides support to the affected area for therapeutic purposes. Specifically, the cutting sections have protruding teeth that abut against the inner wall of the affected area after the prostate stent is placed, effectively preventing stent displacement and ensuring reliable support. This design also simplifies the structure. Furthermore, the presence of protruding teeth on each cutting section eliminates the need for angle adjustments, reducing operational difficulty. The positioning section not only connects the stent body but also positions the implantation direction of the prostate stent, facilitating stent placement and removal without disrupting the patient's daily life, resulting in greater comfort and safety. Attached Figure Description
[0037] To more clearly illustrate the technical solutions in the embodiments of this utility model, the drawings used in the description of the embodiments of this utility model will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on the content of the embodiments of this utility model and these drawings without creative effort.
[0038] Figure 1 This is a schematic diagram of a prostate stent provided in a specific embodiment of this utility model;
[0039] Figure 2 This is a projection view of the prostate stent provided in a specific embodiment of this utility model;
[0040] Figure 3 This is a schematic diagram of the implantation rod of the implantation system provided in a specific embodiment of this utility model;
[0041] Figure 4 yes Figure 3 Enlarged schematic diagram of the clamping end;
[0042] Figure 5 This is a schematic diagram of the implantation system provided in a specific embodiment of the present invention being connected to a prostate stent, with the prostate stent in an expanded state.
[0043] Figure 6 This is a perspective view of the implantation system provided in a specific embodiment of the present invention, when it is connected to a prostate stent and the prostate stent is in a compressed state.
[0044] Figure 7 yes Figure 6 A partially enlarged schematic diagram.
[0045] In the picture:
[0046] 1. Cutting section; 12. Teeth; 2. Rear support section; 3. Positioning section; 4. Front support section; 5. Clamping arm; 6. Implantation rod; 7. Drive assembly; 8. Handle; 9. Positioning groove; 10. Outer sleeve; 11. Handle. Detailed Implementation
[0047] The embodiments of this utility model are described in detail below, with examples of the embodiments shown in the accompanying drawings. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain this utility model, and should not be construed as limiting this utility model.
[0048] The technical solution of this utility model will be further described below with reference to the accompanying drawings and specific embodiments.
[0049] like Figures 1-5 As shown, this embodiment provides a prostate stent, which includes a stent body and a positioning part 3. The stent body includes three parallel and spaced cutting parts 1. The distal ends of every two adjacent cutting parts 1 are connected by a front support part 4, and the proximal end of each cutting part 1 is connected to a rear support part 2. At least one cutting part 1 has one or more protruding teeth 12 on its outer side. The positioning part 3 connects and fixes the three rear support parts 2 together and can position the implantation direction of the prostate stent.
[0050] By setting up interconnected front support 4, cutting section 1, and rear support 2, with the three cutting sections 1 arranged in parallel and spaced apart, and the front and rear ends connected by the front support 4 and rear support 2 respectively, the stent body is a hollow column shape, which can support the affected area to achieve the therapeutic purpose. Specifically, the cutting section 1 is provided with protruding teeth 12, so that after the prostate stent is placed in the human body, the protruding teeth 12 can abut against the inner wall of the affected area, which can effectively prevent the prostate stent from shifting, ensure reliable support of the prostate stent for the affected area, and make the structure simpler and more comfortable; at the same time, since each cutting section 1 is provided with protruding teeth 12, the operator does not need to adjust the angle, reducing the difficulty of operation. By setting up the positioning section 3, the connection of the stent body can be realized, and the stent placement process can be made easier, reducing the difficulty of operation.
[0051] It is understood that the distal and anterior ends are both closer to the patient, while the proximal and posterior ends are both closer to the operator. In other embodiments, protruding teeth 12 can be provided on one of the cutting sections 1, on any two of the cutting sections 1, or on all three cutting sections 1. Protruding teeth 12 can be one or more, with multiples including two, three, four, five, or more. Alternatively, the number of protruding teeth 12 on the three cutting sections 1 can be different, such as one cutting section 1 having no protruding teeth 12, one cutting section 1 having one protruding tooth 12, and another cutting section 1 having multiple protruding teeth 12.
[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 curved metal wires and straight metal wires. This arrangement allows a protrusion to form between the lines connecting the two distal ends of adjacent cut portions when the support body is compressed, facilitating the bending of the support body when the outer sleeve 10 is compressed, until it enters the outer sleeve 10. It can be understood that the protrusion is the bending point where the support body is compressed.
[0053] Specifically, when viewed along the length of the cut section 1, the projections of the three front support sections 4 form an isosceles triangle, and the projections of the three cut sections 1 extend along the angle bisectors 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] For example, the length of the cutting part 1 is between 2cm and 10cm to ensure effective support length for the affected area. For example, it 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. For example, it can be set to 1cm, 2cm, 3cm, 4cm, or 5cm. Furthermore, the cutting part 1 can continuously generate a support force of 0.1N / cm to 5N / cm to provide reliable and stable support for the affected area. For example, it 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 protruding teeth 12 can be triangular, rectangular, trapezoidal, pentagonal, hexagonal, wavy, leaf-shaped, or arc-shaped. Those skilled in the art can set the specific shape of the protruding teeth 12 according to actual needs, as long as it reduces the relative migration between the cutting part 1 and the inner wall of the affected area. The height of the protruding teeth 12 is 1mm-5mm, and can be set to 1mm, 2mm, 3mm, 4mm, or 5mm, reducing relative displacement without damaging the inner wall of the affected area.
[0056] It is worth noting that when a protruding tooth 12 is provided on the outer side of the cutting part 1, the length of the protruding tooth 12 is greater than or equal to one-quarter of the length of the cutting part 1, to ensure a more reliable fit with the inner wall of the affected area. When multiple protruding teeth 12 are provided on the outer side of the cutting part 1, when viewed along the length direction of the cutting part 1, relative to the extension direction of the median of each side of the isosceles triangle, the multiple protruding teeth 12 can be located in the extension direction to improve the anti-migration effect, or they can be deflected to one or both sides of the extension direction to reduce damage to the inner wall of the affected area. Optionally, the deflection angle is between 0-60°. It is understood that if the deflection angle is too large, it 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 of the cutting portion 1, all or part of the plurality of protrusions 12 are inclined toward the distal end of the stent body at an angle of 0-60°, providing greater resistance to the migration of the prostate stent toward the bladder, thereby preventing the prostate stent from migrating into the patient's bladder and improving the safety of prostate stent use. For example, the angle can be set to 0°, 10°, 20°, 30°, 40°, 50° or 60°.
[0058] In this embodiment, the positioning part 3 is an ellipsoid, triangular prism, square prism, pentagonal prism, or hexagonal prism. The positioning part 3 is located inside an 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. This allows the operator to place the prostate stent in the correct position based on the positioning part 3, which corresponds to three angles with the stent body, without adjustment or with only minor adjustments. This reduces the number of steps required during release and thus lowers the difficulty of the release operation. For example, the length direction of one of the three cutting portions 1 can be set to the midline of the major axis or the midline of the minor axis of the positioning portion 3 of the corresponding ellipsoid; or the length direction of one of the three cutting portions 1 can be set to be on the same straight line as the prism direction of one of the three prisms in the positioning portion 3; or the length direction of one of the three cutting portions 1 can be set to be on the same straight line as the prism direction of one of the three prisms in the positioning portion 3; or the length direction of one of the three cutting portions 1 can be set to be on the same straight line as the prism direction of one of the three prisms in the positioning portion 3; or the length direction of one of the three cutting portions 1 can be set to be on the same straight line as the prism direction of one of the three prisms in the positioning portion 3; or the length direction of one of the three cutting portions 1 can be set to be on the same straight line as the prism direction of one of the three prisms in the positioning portion 3. It is understood that the prism-shaped positioning portion 3 makes it easier for the operator to observe its relative positional relationship with the cutting portion 1 of the support body. In other embodiments, the positioning portion 3 can also be set to be spherical. To facilitate observation of the relative positional relationship between the spherical positioning portion 3 and the cutting portion 1 of the support body, corresponding marks can be set on the spherical positioning portion 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 physicochemical properties. The positioning part 3 is made of alloy, polymer material, or a combination thereof, which has better strength. Examples include NiTi alloy, stainless steel, PTFE, TPU, PP, PE, etc.
[0060] Preferably, the cutting part 1, the anterior support part 4, and the posterior support part 2 are surface polished and / or antibacterial treated to ensure that they do not adhere to the prostate surface tissue during the implantation period, making the implantation process smoother; at the same time, reducing the infection site will also significantly reduce the probability of stone formation, which is conducive to the smooth removal of the prostate stent later.
[0061] As an alternative to a prostate stent, the cutting portion 1 is provided with an adhesive layer to improve the reliability of the prostate stent's support to the prostate wall. The adhesive layer includes an anti-adhesion layer that directly contacts the prostate wall and an adhesive layer located between the anti-adhesion layer and the cutting portion 1. It is worth noting that the anti-adhesion layer does not adhere to the prostate wall and can slide relative to it, preventing adhesion between the prostate stent and the prostate wall during implantation and improving the smoothness of implantation; the adhesive layer can adhere to the prostate wall and will not slide relative to it after adhesion, ensuring that the prostate stent adheres to the prostate wall after implantation and does not migrate, providing stable support. For example, the adhesion force between the adhesive layer and the inner wall of the prostate is 0.05 N / cm to 0.5 N / cm, which makes the adhesion more reliable and avoids the migration of the prostate stent. For example, it can be set to 0.05 N / cm, 0.1 N / cm, 0.15 N / cm, 0.2 N / cm, 0.25 N / cm, 0.3 N / cm, 0.35 N / cm, 0.44 N / cm, 0.45 N / cm or 0.5 N / cm.
[0062] Specifically, the anti-adhesion layer can degrade naturally, which facilitates subsequent degradation to expose the adhesive layer. That is, the adhesion between the exposed adhesive layer and the inner wall of the prostate occurs after the anti-adhesion layer has degraded naturally, and the adhesive layer comes into direct contact with the inner wall of the prostate and forms an adhesion.
[0063] Optionally, the adhesive layer can naturally degrade and / or be readily detached to adapt to different usage scenarios. Furthermore, the natural degradation time of the adhesive layer is longer than that of the anti-adhesion layer, preventing the adhesive layer from degrading before the anti-adhesion layer has fully degraded, thus ensuring the prostate stent adheres firmly to the prostate wall. Optionally, the natural degradation time of the anti-adhesion 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 may be disposed on part or all of the outer side of the cutting portion 1. Those skilled in the art may make such a provision according to actual needs, and no specific limitation is made here.
[0065] For example, the adhesive layer includes a temperature-sensitive polymer that loses its adhesion to the inner wall of the prostate at a set temperature. Further, the adhesive layer also includes a bioadhesive material.
[0066] It's worth noting that the adhesion between the adhesive layer and the inner wall occurs after the anti-adhesion layer has completed its natural degradation. The adhesive layer then directly contacts and adheres to the inner wall. Setting the natural degradation time of the anti-adhesion layer to be much shorter than that of the adhesive layer allows the surgeon sufficient time to place the stent in the target location within the prostate. After the anti-adhesion layer has completed its natural degradation, the adhesive layer can directly contact and adhere to the inner wall, securing the stent in place and preventing 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 amine compounds, thiols, imidazoles, maleamide, isocyanates, epoxy compounds, acrylates, catechols, and aryl azides. For example, 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 cause the adhesive force between the adhesive layer and the inner wall to disappear when an aqueous solution of a set temperature is introduced. By incorporating a temperature-sensitive polymer into the adhesive layer, when it is necessary to urgently release the adhesive force of the adhesive layer, an aqueous solution of a set temperature can be introduced into the prostate, causing the adhesive force between the adhesive layer and the inner wall of the cavity to disappear.
[0069] Regarding thermosensitive polymers, when the temperature is below the thermosensitive polymer transition temperature (LCST), the hydrophilic groups within the polymer molecule dominate. These hydrophilic groups form hydrogen bonds with water molecules, creating a dense hydration shell structure, causing the thermosensitive polymer to exhibit an extended "coil" state. At this point, the thermosensitive polymer is soluble. Thermosensitive polymers exhibit a cloud point (CP) or a lower critical dissolution temperature (LCST) in aqueous solutions. Water-soluble thermosensitive polymers are selected to produce low-viscosity liquids when dissolved in water at low temperatures. Raising the temperature above the gelation temperature (Tgel) will cause the composition to solidify. The thermosensitive polymer has an ABA triblock structure, where 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). This thermosensitive polymer is poly(N-substituted (meth)acrylamide). This 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 has a multi-block (ABA-X)m random or repeating configuration, where 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 transformation can occur at temperatures as low as 30°C-40°C. Poly(N-isopropylacrylamide) [poly(NIPAM)] exhibits a low critical dissolution temperature (LCST) of about 31°C in aqueous solution. NIPAM gels undergo a volumetric phase transition from a swollen gel to a shrinking gel in water at approximately 33.6°C. First, the thermosensitive copolymer synthesized from the hydrophilic monomer and the thermosensitive polymer monomer exhibits shrinkage responsive to temperature (human body temperature 36.5°C). Increasing the amount of hydrophilic monomer raises the transition temperature of the resulting thermosensitive copolymer. Therefore, for thermosensitive polymer monomers with inherently high transition temperatures (such as N-isopropylacrylamide), the amount of hydrophilic monomer should not be excessive. Conversely, for thermosensitive polymer monomers with inherently low transition temperatures (such as 2-methyl-2-acrylate-2-(2-methoxyethoxy)ethyl ester), increasing the amount of hydrophilic polymer monomer can raise the transition temperature of the resulting polymer.
[0070] No specific temperature is specified here; those skilled in the art can set it based on the transition temperature of the temperature-sensitive polymer. The aqueous solution can be physiological saline or purified water.
[0071] The anti-adhesion layer prevents adhesion to the inner wall of the prostate, allowing the stent to move within the prostate cavity to its target location. The anti-adhesion layer also delays the release of the adhesive layer, providing the physician with time to maneuver and preventing the stent from adhering to the prostate wall before the implantation procedure is complete. Furthermore, during the stent's shelf life, folding and compressing the stent prevents the adhesive layer from self-adhering and causing stent failure. During prostate implantation, the anti-adhesion layer also ensures the stent can move within the prostate, allowing the physician to place the stent at the target location.
[0072] The surface of the anti-adhesive layer can be smooth or uneven with a certain degree of friction, as long as it does not affect the relative movement of the stent to the wall of the cavity. The anti-adhesive layer includes biodegradable materials, which can be selected from: PLGA (poly(lactic-co-glycolic acid), 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 be selected from one or more of the above biodegradable materials.
[0073] Furthermore, the emergency method for removing the adhesive layer is as follows: an aqueous solution at a set temperature is introduced into the prostate, causing the adhesive layer to lose its stickiness. When removal of adhesion is required, it can be achieved by introducing an aqueous solution at a set temperature; the removal operation is simple and the removal effect is good.
[0074] This embodiment also discloses an implantation system for implanting a prostate stent as described in any of the above embodiments. The implantation system can retract the prostate stent, then implant the retracted prostate stent into the affected area and release it, and can also retract and remove the prostate stent placed in the affected area.
[0075] Specifically, to achieve the connection between the implantation system and the prostate stent, the implantation system includes an implantation rod 6. One end of the implantation rod 6 is configured as a clamping end, which includes two clamping arms 5 that can open and close relative to each other. The clamping arms 5 have internal positioning grooves 9 that match 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 interlock to clamp and fix the positioning part 3, thereby achieving the connection between the implantation system and the prostate stent. It is understood that the size of the positioning groove 9 is not smaller than the size of the positioning part 3.
[0076] Furthermore, the implantation system also includes a drive assembly 7 and a handle 8. The handle 8 is located at the end of the implantation rod 6 furthest from the clamping end. 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 equipped with an operation button, which the operator can use to control the drive assembly 7. The operation button is located on the handle 8 for easy operation. Optionally, the operator can press the operation button to open or close the clamping arm 5 relative to the implantation rod 6.
[0077] Preferably, the implantation system further includes an outer sleeve 10 and a handle 11. The outer sleeve 10 and the handle 11 are slidably fitted onto the outside of the implantation rod 6. The handle 11 is fixed to the outer sleeve 10, allowing the operator to drive the handle 11 to slide the outer sleeve 10 on the implantation rod 6, making the operation more convenient. The prostate stent has a compressed state and an expanded state. In the compressed state, the anterior support portion 4 and the posterior support portion 2 are compressed, and the three cutting portions 1 are close to each other. In the expanded state, the anterior support portion 4 and the posterior support portion 2 are in a natural state, and the three cutting portions 1 are far apart. It is understood that the outer sleeve 10 can drive the prostate stent into the compressed state, where the outer diameter of the prostate stent is smaller and it is located inside the outer sleeve 10, used for implantation and removal operations. When the prostate stent is dislodged from the outer sleeve 10, it can return to the expanded state, where it can be used to support the affected area.
[0078] In use, first, place the positioning part 3 of the prostate stent into the positioning groove 9 of the clamping arm 5. Drive the clamping arm 5 via the drive assembly 7 to clamp and fix the positioning part 3. Then, as the outer tube 10 slides away from the handle 8 via the pull handle 11, the prostate stent is gradually compressed by the outer tube 10 and retracted into it. At this point, the prostate stent is compressed and completely placed within the outer tube 10, facilitating implantation. After implanting the compressed prostate stent into the affected area, keep the implantation system as still as possible. As the outer tube 10 slides closer to the handle 8 via the pull handle 11, the prostate stent gradually detaches from the outer tube 10 and, under its elastic recovery force, returns from a compressed state to an expanded state to support the affected area, providing outward pressure to the prostate tissue and creating an incision in the prostate wall tissue, thereby alleviating prostate enlargement. If the position of the prostate stent needs adjustment, it can be adjusted by rotating the implantation system. After adjustment, drive the clamping arm 5 to open, disengaging it from the positioning part 3, and then remove the implantation system.
[0079] After the prostate stent has been in place for a period of time, an incision has formed in the inner wall of the prostate, and the prostate enlargement has been relieved. When it is necessary to remove the prostate stent from the affected area, under the guidance of a cystoscope, first insert one end of the implantation 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 to open the clamping arm 5 relative to the implantation rod 6, locate the positioning part 3 under the cystoscope, and press the operation button again to close the clamping arm 5 relative to the implantation rod 6 and clamp the positioning part 3. Keep the outer cannula 10 as still as possible, pull the handle 8 towards the side closer to the operator to move the implantation rod 6, and then gradually retract the prostate stent into the outer cannula 10. When the prostate stent is completely placed in the outer cannula 10, ensure that the outer cannula 10 and the implantation rod 6 are relatively still and gradually remove the implantation system and the prostate stent from the body. At this point, the prostate stent removal is complete.
[0080] The above description is only a preferred embodiment of this utility model. For those skilled in the art, there will be changes in the specific implementation method and application scope based on the idea of this utility model. The content of this specification should not be construed as a limitation of this utility model.
Claims
1. A prostate stent, characterized in that, include: The support body includes three parallel and spaced cutting sections (1), the distal ends of every two adjacent cutting sections (1) are connected by a front support section (4), and the proximal end of each cutting section (1) is connected by a rear support section (2); at least one cutting section (1) has one or more protruding teeth (12) on its outer side. The positioning part (3) connects and fixes the three rear support 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 viewed along the length of the cut section (1), the projections of the three front support sections (4) form an isosceles triangle, with the vertex angle of the isosceles triangle ranging from 20° to 60°.
3. The prostate stent according to claim 2, characterized in that, The length of the cut section (1) is 2cm-10cm; the length of the height perpendicular to the base of the isosceles triangle is 1cm-5cm.
4. The prostate stent according to claim 2, characterized in that, 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.
5. The prostate stent according to claim 4, characterized in that, The spatial position and angle of the positioning part (3) relative to the bracket body are fixed.
6. The prostate stent according to claim 2, characterized in that, When a tooth (12) is provided on the outer side of the cutting part (1), the length of the tooth (12) is greater than or equal to one-quarter of the length of the cutting part (1); when multiple teeth (12) are provided on the outer side of the cutting part (1), when viewed along the length direction of the cutting part (1), relative to the extension direction of the median of each side of the isosceles triangle, the multiple teeth (12) can be located in the extension direction, or they can be deflected to one or both sides of the extension direction, with a deflection angle of 0-60°.
7. The prostate stent according to claim 1 or 6, characterized in that, Along the length of the cutting portion (1), all or part of the plurality of protruding teeth (12) are inclined toward the distal end of the support body, with an inclination angle of 0-60°.
8. The prostate stent according to claim 1, characterized in that, The shape of the protruding tooth (12) is triangular, rectangular, trapezoidal, pentagonal, hexagonal, wavy, leaf-shaped or arc-shaped, and the height of the protruding tooth (12) is 1mm-5mm.
9. The prostate stent according to claim 1, characterized in that, The cutting part (1), the front support part (4) and the rear support part (2) are all made of NiTi alloy, and the positioning part (3) is made of alloy, polymer material or a combination thereof.
10. The prostate stent according to claim 1, characterized in that, The cutting section (1) can continuously generate a supporting force of 0.1N / cm-5N / cm outward.
11. The prostate stent according to claim 1, characterized in that, The cutting part (1), the front support part (4) and the rear support part (2) are surface polished and / or antibacterial treated.
12. The prostate stent according to claim 1, characterized in that, An adhesive layer is provided on the cutting part (1), the adhesive layer including an anti-adhesion layer that is in direct contact with the inner wall of the prostate and an adhesive layer located between the anti-adhesion layer and the cutting part (1).
13. The prostate stent according to claim 12, characterized in that, The non-stick layer is capable of natural degradation, the adhesive layer is capable of natural degradation and / or emergency release of adhesion, and the natural degradation time of the adhesive layer is longer than that of the non-stick 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 relative to it; the adhesive layer can adhere to the inner wall of the prostate and will not slide relative to it 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 anti-adhesion layer has naturally degraded, at which point the adhesive layer comes into direct contact with the inner wall of the prostate and forms an adhesion.
16. The prostate stent according to claim 12, characterized in that, The adhesive layer is disposed on part or all of the outside of the cut portion (1).
17. The prostate stent according to claim 13, characterized in that, The adhesive layer includes a temperature-sensitive polymer that loses 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 method for removing the adhesive layer is to introduce an aqueous solution at a set temperature into the prostate, causing the adhesive layer to lose its stickiness.
19. The prostate stent according to claim 13, characterized in that, The natural degradation time of the anti-stick 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 12-14, characterized in that, The adhesion force between the adhesive layer and the inner wall of the prostate is 0.05 N / cm to 0.5 N / cm.
21. The prostate stent according to claim 1, characterized in that, The front support (4) is formed by connecting at least two straight metal wires, or by connecting one or more arc-shaped metal wires, or by connecting arc-shaped metal wires and straight metal wires.
22. An implantable system, characterized in that, For implantation of a prostate stent as described in any one of claims 1-21.
23. The implantation system according to claim 22, characterized in that, The implantation system includes an implantation rod (6), one end of which is configured as a clamping end. The clamping end includes two clamping arms (5) that can be opened and closed relative to each other. The clamping arms (5) are provided with positioning grooves (9) that match the shape of the positioning part (3). The two clamping arms (5) can clamp and fix the positioning part (3) after they are closed together.
24. The implantation system according to claim 23, characterized in that, The implantation system is also provided with a drive assembly (7) and a handle (8). The drive assembly (7) is used to drive the clamping arm (5) to open and close, and the handle (8) is located at the end of the implantation rod (6) away from the clamping end.
25. The implantation system according to claim 24, characterized in that, The implantation system also includes an outer tube (10) and a handle (11). The outer tube (10) and the handle (11) are slidably sleeved on the outside of the implantation rod (6). The handle (11) is fixed on the outer tube (10) and can drive the outer tube (10) to slide on the implantation rod (6).
26. The implantation system according to claim 25, characterized in that, The prostate stent has a compressed state in which three cutting portions (1) are close to each other and an expanded state in which three cutting portions (1) are far apart from each other. The prostate stent can be placed in the outer tube (10) in the compressed state, and as the handle (11) drives the outer tube (10) to slide towards the handle (8), the prostate stent gradually returns to the expanded state.
27. The implantation system according to claim 26, characterized in that, When the positioning part (3) is placed into the positioning groove (9) of the clamping arm (5), the clamping arm (5) is driven by the driving component (7) to fasten and fix the positioning part (3). When the outer tube (10) is slid away from the handle (8) by the handle (11), the prostate stent is gradually compressed to the compressed state by the outer tube (10).