[go: up one dir, main page]

WO2025045068A1 - 一种悬挂式自适应前列腺支架 - Google Patents

一种悬挂式自适应前列腺支架 Download PDF

Info

Publication number
WO2025045068A1
WO2025045068A1 PCT/CN2024/115021 CN2024115021W WO2025045068A1 WO 2025045068 A1 WO2025045068 A1 WO 2025045068A1 CN 2024115021 W CN2024115021 W CN 2024115021W WO 2025045068 A1 WO2025045068 A1 WO 2025045068A1
Authority
WO
WIPO (PCT)
Prior art keywords
stent
prostate
suspension structure
stent according
bearing ring
Prior art date
Application number
PCT/CN2024/115021
Other languages
English (en)
French (fr)
Inventor
王伯涛
Original Assignee
王伯涛
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202322340777.XU external-priority patent/CN221130121U/zh
Priority claimed from CN202323136447.5U external-priority patent/CN221750949U/zh
Application filed by 王伯涛 filed Critical 王伯涛
Publication of WO2025045068A1 publication Critical patent/WO2025045068A1/zh

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

  • the present invention belongs to the technical field of medical devices, and in particular, relates to a prostate stent for alleviating pain caused by prostate hyperplasia.
  • Prostatic hyperplasia is one of the common diseases in middle-aged and elderly men.
  • the incidence rate is 50% to 60% for those over 50 years old.
  • the incidence rate will increase by about 10% for every 10 years of age over 60 years old, and the incidence rate can be as high as 90% for those over 80 years old.
  • the direct consequence of prostatic hyperplasia is urethral stenosis, which is clinically manifested as frequent urination, urgency, and difficulty urinating, which is very painful. About 25% of patients have to undergo surgical treatment. In addition to the traumatic pain and high medical expenses brought to patients by surgical treatment, the widespread sequelae are daunting.
  • a prostate stent is a physical device placed in the prostate urethra to relieve lower urinary tract symptoms caused by benign prostatic hyperplasia and other prostate diseases. It is an alternative treatment for urethral catheterization. Prostate stent treatment for prostate hyperplasia is classified as a non-drug, non-surgical treatment.
  • a temporary stent is also called a non-epithelialized stent, which means it always covers the outside of the urethral epithelium and will not be embedded in the epithelium.
  • a permanent stent is also called an intraprostatic stent; the urothelium can grow on the stent and cover the surface of the stent, and eventually gradually embed into the prostate tissue. This is what we usually say "growing into the flesh.”
  • prostate stents are mostly metal mesh stents or coated metal mesh stents.
  • they rely on the strong elasticity of the metal material itself to expand, swell, and support the urethral wall for initial anchoring and positioning. This anchoring method will cause patients to suffer from persistent pain, discomfort, or foreign body sensation.
  • the intraprostatic stent cannot be replaced at will. If it is to be removed, the urethral epithelial tissue must be surgically cut to achieve this, and a new stent cannot be placed immediately.
  • the coated stent also has many problems such as displacement or even slippage after placement.
  • Prior art Chinese patent application No. 200780019099.8 discloses a method of using threaded concave-convex patterns on the surface of a stent as an anchoring structure.
  • the reliability of this anchoring structure is seriously questionable, and there is a great risk of slippage and displacement.
  • a fixing frame is used, but it is difficult to keep balance when in the body and it is very easy to tilt and get stuck at the bladder neck.
  • the fixing frame and the urethral stent are connected by only one thin wire, and the lower end is connected to one side of the upper opening of the urethral stent.
  • the connecting thin wire cannot keep a straight state, which is bound to produce a lasting pressure, pricking, strangling, and cutting stress on the bladder sphincter. Over time, it can even be embedded in the bladder neck muscle, which will undoubtedly cause continuous pain, discomfort or foreign body sensation to the patient.
  • the present invention is designed to address various problems of prostate stents in the prior art, and is designed in combination with the safety, convenience, and effectiveness of clinical applications and the feasibility and stability of industrial production, as well as the approval of medical ethics and national regulations.
  • Biosafety is the primary consideration for medical products.
  • the present invention adopts organic polymer materials with good biocompatibility and high safety or metal alloy materials through reasonable matching and organic compounding. Multiple materials are shared, rigid and flexible, complementing each other, and can perfectly exert the expected design effect of the stent.
  • the present invention abandons the need for anchoring structures or elastic expansion support positioning of general stents, and rejects the idea of permanent in-body embedding inside tissues, so as to reduce the patient's pain, discomfort or foreign body sensation.
  • the overall idea of the present invention is to conform to the natural space of the cavity based on the anatomical characteristics of the urethra, adopt a suspended structure for positioning, and adapt to the physiological process of bladder sphincter contraction and relaxation without affecting autonomous urination and urine locking functions.
  • the invention concept of a small-scale stent body is to reduce patient discomfort and foreign body sensation, so that the product fits the tissue better, adapts to physiological functions, reduces the patient's postoperative pain, and enhances the patient's compliance and comfort in the body during clinical applications.
  • the present invention is divided into three parts: upper, middle and lower according to the functions of the stent.
  • the upper part is the suspension structure
  • the lower part is the prostate stent body
  • the middle part is the transition connection structure between the suspension structure and the stent body.
  • the function of the suspension structure is to suspend and position the stent body. When in the body, it is located in the bladder cavity above the urethral opening and bears and evenly distributes the gravity of the lower stent body itself and the downward flushing force of urine on the stent body during urination, thereby ensuring that the stent body will not shift downward or slip.
  • the suspension structure is designed to be in a spiral or inverted cone shape and a flexible material is selected so that it can be surface-to-surface embedded with the internal opening of the urethra and the surrounding bladder tissue to reduce local irritation of the bladder neck.
  • a load-bearing ring is provided at the upper opening of the suspension structure, and has a certain elasticity.
  • the elasticity of the load-bearing ring allows the suspension structure to fully stretch in the bladder, and the gravity of the lower support body and the flushing force of urine during urination can be evenly dispersed on the load-bearing ring through the side wall structure, which is both rigid and flexible, and can ensure the stability of the suspension structure when in the body.
  • the load-bearing ring also has a certain degree of flexibility and deformability, which is sufficient to facilitate the insertion or removal of it into the body through the external urethra with the help of instruments.
  • the positioning concept of the suspension structure is the key innovative technology of the present invention.
  • the load-bearing ring can also be made into a hollow body or a thin-walled tubular body. The latter is injected with liquid or gas before use, and the internal pressure makes it elastic and flexible.
  • the side wall of the spiral or cone-shaped body of the suspension structure is soft and weak, has limited physical strength, and is easily torn. Reinforcements of other heterogeneous materials may be added therein, or strip or mesh structures may be attached to the surface to enhance its tear resistance.
  • one or more holes are set at the junction of the upper edge of the side wall of the vortex or cone of the suspension structure and the bearing ring as the grasping site of the urethral intervention device to avoid the tearing and damage of the side wall of the suspension structure caused by the push and pull of mechanical force.
  • the edge can be thickened and strengthened, and the overall shape of the hole can be made as smooth as possible.
  • the stent body is the main structure that performs its basic functions such as dilating the urethra and unblocking urine flow.
  • a channel space is indispensable in terms of physical structure, so the tubular structure is the preferred physical form.
  • a spindle-shaped cystic body with a large puff in the middle can also be selected.
  • the stent body does not need to consider the anchoring device, which can greatly simplify the physical structure of the stent body.
  • it is necessary to minimize the size of the physical size of the stent body while ensuring the functional effectiveness of the stent body. This is a disruptive improvement for the stent that previously relied on expansion positioning.
  • the outer surface of the stent body may be provided with some transverse annular protuberances, which are axially distributed on the outer surface of the stent body, equidistant or uneven, and the overall appearance is bamboo-like.
  • the annular protuberances can prevent the stent body from sliding frequently and slightly in the urethra, and have a certain help in anchoring the position in the body, but do not play a decisive role.
  • the cross section of the transverse annular protuberance is smooth, triangular or arched.
  • the supporting force of the tube wall of the stent body is the basis for maintaining the patency of the inner lumen of the pipeline.
  • reinforcing ribs with appropriate rigid elastic force can be added while appropriately increasing the wall thickness to ensure that the stent body has sufficient and appropriate rigid supporting force.
  • the reinforcing ribs in the tube wall of the stent body can be made of organic polymer materials with higher hardness, or metal alloy materials.
  • the reinforcing ribs can be designed as spiral spring tubes with equal or uneven pitch; or as a combination of two or more unconnected single rings, axially distributed in the tube wall, with equal or uneven spacing.
  • the spiral spring tube or the single ring combination can be of equal diameter or unequal diameter.
  • the reinforcing ribs can also be designed as mesh tubular bodies with various patterns and plane shapes, and the mesh size and shape can vary with the material and manufacturing process.
  • the reinforcing body can be made of metal or non-metal materials, but should have a certain degree of softness and moderate rigidity. The design of the reinforcing body itself and the appropriate related parameters are well known in the field of human body stents.
  • the transition connection between the suspension structure and the bracket body is another key innovative technology of the present invention. It is a structure that connects the suspension structure and the bracket body into a whole, with its upper end connected to the lower end of the suspension structure, and the lower end connected to the upper end of the bracket body.
  • the connection structure When the bracket is placed in the human body, the connection structure is located in the urethra at the bladder sphincter (one of the three narrow parts of the male urethra). Functionally, it can neither interfere with the contraction of the bladder sphincter nor interfere with the relaxation of the bladder sphincter.
  • the contraction and relaxation of the bladder sphincter correspond to the urinary locking function and urination function of the bladder, respectively. Any factors that may affect the contraction and relaxation of the bladder sphincter can lead to abnormalities in the bladder's urinary locking function and urination function.
  • the present invention adopts the following measures to meet this technical demand. First, ultra-soft materials are selected, and then ultra-thin structures are adopted, and then combined with the physical design of the tubular body, multiple measures are taken to achieve the goal of not affecting the contraction function of the bladder sphincter, nor affecting the relaxation function of the bladder sphincter. Ultimately, the abnormality of the bladder's normal urine locking and autonomous urination functions due to the influence of the stent is avoided.
  • reinforcing ribs of homogeneous material can be arranged on its surface or heterogeneous material can be arranged in its wall to increase its physical strength, but it should not significantly affect its function.
  • the reinforcing ribs can be made into strips, distributed longitudinally, or in a mesh shape.
  • the novel stent of the present invention can be further used as a convenient drug carrier.
  • the prostatic urethra mucosal epithelial cells do not have a stratum corneum, and the drug can easily and quickly penetrate the skin with a high penetration rate, which is the closest site for transdermal administration of prostatic diseases.
  • the prostatic urethra runs through the prostate, and the drug can immediately reach the prostatic tissue and directly reach the lesion after penetrating the mucosal epithelial cells, which is one of the most promising topics for transdermal administration of prostatic diseases.
  • the bracket body is positioned by a suspension structure, and its upper load-bearing ring and spiral or inverted cone shape are important details for achieving the special effect of the suspension structure; (2) the ultra-thin connection structure in the middle will not affect the normal physiological function of the bladder sphincter; (3) the bracket body abandons its anchoring structure and functions in the body at the smallest scale, which can avoid many application sequelae; and (4) as a drug carrier, it provides an effective method for transurethral mucosal transdermal drug administration for prostate diseases.
  • FIG. 1 is a perspective schematic diagram of an embodiment.
  • FIG. 2 is a schematic diagram of a use state of an embodiment.
  • FIG. 3 is a front view of an embodiment.
  • FIG4 is a cross-sectional view along direction D in one embodiment, wherein axis D is the central axis of the entire prostate stent.
  • Suspension structure 1: Suspension structure; 2: Transition connection structure; 3: Bracket body; 4: Reinforcement ribs.
  • the suspended adaptive prostate stent of the present invention is made of organic polymer material and metal alloy material.
  • the organic polymer material is preferably silicone material
  • the metal alloy material is preferably titanium alloy or medical stainless steel.
  • the suspended adaptive prostate stent can be divided into three parts: upper, middle and lower according to its structure.
  • the upper part is the suspension structure 1
  • the lower part is the prostate stent body 3
  • the middle part is the transition connection structure 2 between the suspension structure and the stent body.
  • the upper suspension structure is generally in a spiral shape or an inverted cone shape, preferably a spiral shape; the diameter of the upper opening is 3 to 50 mm, Optimized to 5 ⁇ 30mm; lower opening diameter 1 ⁇ 15mm, optimized to 3 ⁇ 10mm; height 3 ⁇ 50mm, optimized to 8 ⁇ 30mm; wall thickness 0.01 ⁇ 3mm, optimized to 0.05 ⁇ 2mm.
  • the upper opening edge of the suspension structure has a load-bearing ring, whose cross section is quasi-circular, quasi-rectangular or quasi-semicircular, preferably quasi-circular, with a diameter of 0.5-8 mm, preferably 1-4 mm.
  • the load-bearing ring can be hollow or solid, preferably solid.
  • the ring body may or may not contain reinforcing ribs, and the reinforcing ribs 4 may be made of one to more strands of metal alloy material or other materials. Preferably, there is no reinforcing rib.
  • the suspension structure 1 may have reinforcing ribs made of homogeneous or heterogeneous materials on the surface or inside the side wall of the vortex or cone; preferably, the reinforcing ribs are arranged on the surface and made of homogeneous materials.
  • the reinforcing ribs 4 may be strip-shaped or grid-shaped, preferably strip-shaped, with one or more strips, arranged longitudinally, and located on the inner surface of the suspension structure; the upper end is connected to the lower edge of the load-bearing ring, and the lower end is connected to the lower opening of the suspension structure.
  • the cross section of the reinforcing rib is triangular, and the width and height are respectively 0.1 to 0.8 mm, preferably 0.2 to 0.5 mm.
  • the suspension structure 1 has one or more equally or unevenly distributed hollow holes at the junction of the bearing ring and the side wall of the vortex or cone, that is, on the side wall of the vortex or cone at the lower edge of the bearing ring, and is preferably 1 to 4 and symmetrically distributed; the hollow holes are semicircular or inverted triangles, with a width and height of 0.5 to 5 mm, and are preferably inverted triangles, with a width and height of 2 to 4 mm.
  • the edges of the hollow holes can be appropriately thickened.
  • the suspended adaptive prostate stent has a cylindrical tubular body or a spindle-shaped sac-like structure with a large middle part, preferably a cylindrical tubular body. Both ends are open.
  • the inner diameter of the tube body is 2 to 15 mm, preferably 3 to 8 mm; the wall thickness is 0.1 to 4 mm, preferably 0.2 to 2 mm, and the length is 10 to 100 mm, preferably 2 to 80 mm.
  • the outer surface of the lower support body 3 has a plurality of transverse annular protrusions.
  • the cross section of the protrusion ring is arched, with a width of 1 to 5 mm, preferably 2 to 3 mm, and a height of 0.1 to 2 mm, preferably 0.2 to 1 mm.
  • the tube wall of the lower support body 3 contains reinforcing ribs.
  • the reinforcing ribs are in the shape of a spiral spring tube, or in various patterns and mesh shapes, or in the combination of two or more unconnected single rings, preferably in the shape of a spiral spring tube, with equal or uneven pitch, preferably equal pitch, 0.1 to 4 mm, preferably 0.2 to 3 mm, and axially distributed in the tube wall.
  • the presence of the reinforcing ribs can overcome external pressure to maintain an unobstructed lumen of the support body, and its design and parameters can be routinely adjusted by those skilled in the art according to the requirements and specific embodiments of the present invention.
  • the transition connection structure 2 of the suspended adaptive prostate stent is a transition connection between the suspension structure and the stent body, and is tubular; the upper end is connected to the lower end of the suspension structure 1, and the lower end is connected to the upper end of the stent body 3; the length is 2 to 30 mm, and the optimized length is 5 to 20 mm; the wall thickness is 0.02 to 2 mm, and the optimized length is 0.05 to 1 mm.
  • the design and parameters of the middle transition connection structure 2 can be routinely adjusted by those skilled in the art according to the requirements and specific embodiments of the present invention.
  • the general principle is that its structure should be easily affected by the bladder sphincter and be in an occluded state. At the same time, when the bladder sphincter is released, it is easy to be affected by the internal liquid pressure and its own elasticity to make the internal cavity present a dilated state.
  • connection structure between the suspension structure 1 and the support body 3 may be provided with strip or grid-shaped reinforcement ribs on its surface.
  • the reinforcement ribs are strip-shaped, one or more, arranged longitudinally, and located on the inner surface of the tubular body of the transition connection structure 2; the upper end is seamlessly connected to the reinforcement ribs on the inner surface of the side wall of the suspension structure 1, and the lower end is connected to the upper end of the support body 3.
  • the suspended adaptive prostate stent of this embodiment is made of a composite of organic polymer material and metal alloy material.
  • the organic polymer material is made of silicone material
  • the metal alloy material is made of medical stainless steel.
  • the suspended adaptive prostate stent of this embodiment has an upper suspension structure 1 in a spiral shape, with an upper outer diameter of 25 mm, a lower inner diameter of 5 mm, a height of 13 mm, and a wall thickness of 0.3 mm.
  • a bearing ring is provided at the upper edge of the upper suspension structure, and the cross section of the bearing ring is circular with a diameter of 2.5 mm.
  • Three reinforcing ribs are provided on the side wall of the spiral body. They are arranged equidistantly in the longitudinal direction and are located on the inner surface of the suspension structure; the upper end is connected to the lower edge of the bearing ring, and the lower end reaches the upper opening of the bracket body and ends at the middle of the first transverse annular protrusion on the outer surface of the corresponding bracket body.
  • the cross section of the reinforcing rib is triangular, with a height of 0.2 mm and a bottom width of 0.4 mm.
  • the suspended adaptive prostate stent of this embodiment has a lower stent body 3 that is a cylindrical tubular structure with open ends; the tube body is 46.5 mm long, 5 mm in inner diameter, and 0.5 mm in wall thickness.
  • transverse annular protrusions are arranged on the outer surface of the lower support body 3.
  • the cross section of the protrusion is arch-shaped, with a chord width of 3 mm and a chord height of 0.5 mm.
  • Reinforcement ribs are arranged in the tube wall of the support body 3, which is in the shape of a spiral spring tube.
  • the middle structure 2 is a transitional connection between the upper suspension structure and the lower stent body, and is tubular; the upper end is connected to the lower end of the suspension structure, and the lower end is connected to the upper end of the stent body; the length is 12mm, the inner diameter is 5mm, and the wall thickness is 0.2mm.
  • the inner surface has a reinforcing rib 4 from the suspension structure passing through longitudinally.
  • Mould Made of aluminum alloy material and commissioned by a specialized CNC company for precision processing.
  • Stainless steel spiral spring tube 42.5mm long, 5.2mm inner diameter. Made of SUS316LVM stainless steel wire, 0.2286mm diameter. 0.75mm pitch. Manufactured by a specialized industrial spring manufacturer.
  • Medical syringes comply with relevant regulations.
  • the second embodiment of the present invention is a suspended adaptive prostate stent, which is the same as the first embodiment.
  • the upper end outer diameter of the upper suspension structure 1 is 28 mm, the inner diameter of the lower opening is 5.5 mm.
  • the cross-section diameter of the load-bearing ring is 3 mm.
  • the suspension structure 1 is provided with 4 holes, and 4 reinforcing ribs 4 are formed accordingly.
  • the main body of the lower bracket of the second embodiment is 55mm long, with an inner diameter of 5.5mm, and 6 transverse annular protrusions are arranged on the outer surface.
  • the inner wall spiral spring tube is 51mm long and with an inner diameter of 5.7mm;
  • the tubular body of the middle transition connection structure 2 is 14 mm long and has an inner diameter of 5.5 mm.
  • the suspended adaptive prostate stent is pressed into a special catheter, which is then sent to the internal opening of the bladder through the external urethral opening.
  • the catheter is withdrawn and the stent is released into the prostate at the same time.
  • the position and posture of the stent are checked under cystoendoscopy to see if they are appropriate, and can be adjusted to a suitable position with foreign body forceps.
  • the stent can also be removed from the body using a cystoendoscope and a special foreign body forceps.
  • the cystoendoscope is inserted into the urethra and passed through the inner cavity of the stent body to enter the bladder opening.
  • the cystoendoscope and the special foreign body forceps are operated to clamp the bearing ring of the suspension structure with the forceps mouth, and the bearing ring is slowly pulled to pull one side of the suspension structure 1 toward the bladder opening. Since the entire suspension structure 1 is soft, the bearing ring and the entire suspension structure are folded at this time.
  • the cystoendoscope is slowly withdrawn, and the folded and deformed bearing ring and the entire suspension structure can enter the urethra through the bladder opening under the traction of the foreign body forceps.
  • the folded bearing ring cannot enter the inner cavity of the stent body; as the cystoscope is withdrawn, the pulling force of the foreign body forceps on the bearing ring will drive the stent body to slide down along the urethra. Until the cystoscope is completely withdrawn, the entire prostate stent is removed.
  • prostate stents In the existing public information, prostate stents mostly rely on their own strong radial elastic expansion and expansion support to the inner wall of the urethra for initial anchoring and positioning. This anchoring method can cause bleeding, continuous pain, irritation, discomfort or foreign body sensation to patients.
  • metal stents cannot be replaced at will due to the growth and embedding of epithelial cells. If they are to be removed, the urethral epithelial tissue must be surgically cut open, and a new stent cannot be placed immediately. Covered stents may shift or even slip after placement, and may also cause ischemia and necrosis of tissues around the urethra or even part of the prostate due to long-term compression of the stent.
  • the present invention abandons the idea of elastic expansion support positioning, and adopts a suspension structure positioning according to the anatomical characteristics of the male urethra and the natural space of the cavity, thereby greatly reducing the physical size of the stent body, thereby reducing or eliminating the pain, discomfort or foreign body sensation of the patient after the stent is placed.
  • the suspension structure 1 is embedded in the urethral internal opening and the bladder cavity above it, bearing and evenly dispersing the gravity of the lower stent body 3 and the downward flushing force of urine on the stent body during urination, thereby ensuring that the stent body will not shift downward or slip.
  • the suspension structure 1 is in a spiral or inverted triangle shape and is made of flexible material, so that it can be embedded in the urethral opening and the surrounding bladder tissue in a face-to-face manner to reduce local irritation of the bladder neck.
  • the elastic bearing ring of the suspension structure 1 can make the suspension structure 1 fully stretch in the bladder, so that the suspension structure 1 is both rigid and flexible, and the posture of the suspension structure 1 can be ensured to be stable when in the body.
  • the elastic bearing ring also has a certain degree of flexibility and deformability, which is sufficient to facilitate the insertion or removal of the suspension structure 1 into the body through the external urethra with the help of instruments.
  • the urination process of normal men under voluntary consciousness is controlled by two barriers, the upper sphincter and the lower sphincter.
  • the upper sphincter is the bladder sphincter
  • the lower sphincter is the urethral sphincter.
  • both the upper and lower sphincters are in a contracted state, completely locking the urine in the bladder.
  • the upper and lower sphincters relax at the same time under the control of voluntary consciousness, and the two gates of the urethra are fully opened.
  • the bladder detrusor contracts, and urine is able to pass through the urethra and be discharged from the body under the pressure of the bladder detrusor contraction.
  • the bladder detrusor relaxes, and the upper and lower urethral sphincters return to a contracted state at the same time. Therefore, under normal conditions, urine in the bladder will not involuntarily flow out of the body through the urethra.
  • some external force such as medical equipment, or surgical damage such as prostatectomy, or a disease causes the urethral sphincter or a sphincter to contract incompletely, it can lead to urinary incontinence, urine leakage, or stress urinary incontinence.
  • the bladder sphincter is the first barrier of the human body to lock the urine in the bladder.
  • the bladder sphincter and its internal urethral opening are mechanically stretched open under the physical action of the stent or device, so that the "gate” between the bladder and the prostatic urethra, namely the internal urethral opening, is forcibly opened, the basic physiological function of the bladder sphincter is released, and the first barrier to lock the urine is also lost. Therefore, the "burden” of the human body to control urine falls entirely on the urethral sphincter. Due to the loss of a "gate", the body's autonomous urine locking function will be greatly reduced, so clinically it may manifest as postoperative pathological symptoms such as urine leakage, urinary incontinence, especially stress urinary incontinence.
  • the present invention provides a thin-walled, soft and elastic tubular connection structure between the prostate stent body and the accessory device at the position corresponding to the bladder sphincter, so that it can adapt to the relaxation and contraction function of the bladder sphincter and open and close accordingly with the opening and closing of the internal urethral opening. This is undoubtedly the most effective measure to preserve the patient's normal physiological urine locking function and avoid adverse reactions such as urine leakage or urinary incontinence after the use of an inappropriate stent.
  • the present invention is consistent with the anatomical characteristics of the human body cavity, and can fully avoid the influence on the patient's bladder sphincter function, thereby avoiding the adverse consequences caused by the implantation of the stent.
  • the small-scale structure of the stent body can be realized.
  • the small-scale structure may cause the stent body to slide freely in the prostate in the longitudinal direction with a small amplitude under the action of slight external forces such as levator anus and other physiological forces.
  • the present invention provides a raised transverse annular structure on the outer surface of the stent body, which can prevent the stent body from sliding freely in the longitudinal direction with a small amplitude in the prostate, and also has a certain synergistic effect on its overall anchoring and positioning.
  • Topical transdermal drug delivery has many advantages, such as no first-pass effect, small dosage, high drug concentration in the tissue at the administration site, no systemic effect, small toxic and side effects, high clinical efficacy, and good patient compliance.

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)

Abstract

一种悬挂式自适应前列腺支架，属于医疗器械技术领域。按其功能结构可分为上、中、下三个部分：上部为悬挂结构（1），大体呈旋涡状或倒圆锥形；上口具承力环，中空或内实，环体中可设加强筋（4）；其侧壁可设置加强筋（4），侧壁上缘与承力环交界处，可设有若干镂孔。下部为前列腺支架主体（3），总体呈管状或中部彭大的纺锤形囊状体；外侧可设置若干横向隆起，壁中可设置抗压加强筋（4）。中部为悬挂结构（1）与支架主体（3）的过渡连接结构（2），呈一超薄柔软管状体，表面可设置若干加强筋。支架整体由高分子材料或与金属材料复合制成，可用于前列腺疾病引起的尿路阻塞、狭窄所引起的排尿困难、不畅等问题，也可以作为前列腺疾病经尿道透皮给药系统的载体。

Description

一种悬挂式自适应前列腺支架 技术领域
本发明属于医疗器械技术领域，具体地，涉及一种前列腺支架，用于减缓前列腺增生带来的病痛。
背景技术
前列腺增生症是中老年男性的常见疾病之一，50岁以上的发病率为50％～60％，60岁以上每增加10岁其发病率将上升约10％，80岁以上的发病率可高达90％。前列腺增生的直接后果是造成尿道狭窄，临床表现为尿频、尿急、排尿困难，十分痛苦。其中约25％的患者不得不接受手术治疗。手术治疗除了给病人带来创伤痛苦及高额的医疗费用以外，广泛普遍的后遗症令人望而生畏。据介绍，前列腺切除术后，后遗症主要有阳痿(85％～90％)、完全性尿失禁(1％～5％)、压力性尿失禁(5％～20％)、直肠损伤(1％～7％)、膀胱尿道吻合口狭窄(2％～23％)、切口感染(2％～20％)等，甚至还有因手术而造成患者的死亡(1％～5％)。而且，本领域技术人员知道，任何手术都不是完美的。特别是前列腺摘除术后勃起障碍，这给中老年病人本就捉襟见肘的性功能雪上加霜。因此，人们想到了使用前列腺支架作为一种简单、有效、无创、价廉、痛苦小，可摘除、可重复解决方案之一。
前列腺支架是放置在前列腺部尿道，可以缓解前列腺良性增生和前列腺其它疾病所致下尿路症状的一种物理装置。作为导尿的一种替代治疗方法。前列腺支架治疗前列腺增生被列为非药物、非手术治疗范畴。
前列腺支架可分为两种类型。一类为暂时性支架，一类为永久性支架。暂时性支架又叫非上皮化支架，即始终覆盖于尿道上皮组织之外，不会嵌入上皮组织内部。永久性支架又叫前列腺内支架；尿路上皮可在支架上生长并覆盖支架表面，最终逐渐嵌入前列腺组织内部。即我们平时俗话所说的“长到肉里去了”。
1980年Fabian首先介绍了金属螺旋支架置入前列腺尿道治疗下尿路梗阻。1990年代之后，国内陆续出现相关技术。在现有公开资料中，前列腺支架多为金属网状支架或覆膜金属网状支架，但无论如何，均是依靠其金属材料本身强力的弹性，扩张、膨胀、支撑于尿道内壁赖以初期的锚定定位，这种锚定方式会给患者带来持续的疼痛、不适或异物感。另外，前列腺内支架不可随意更换，若要取出，必需手术切开尿道上皮组织方能如愿，且不能立即放置新的支架。而覆膜支架还存在置入后移位甚至滑脱等诸多问题。
现有技术中国专利申请号200780019099.8公布了一种以支架表面的螺纹状凹凸纹作为锚定结构，但这种锚定结构的可靠性严重存疑，存在较大的滑脱和移位的风险。
现有技术申请号200610153278.8中，采用一种固定架，但其在体时很难保持平衡，极易歪斜卡顿于膀胱颈处。另外，固定架与尿道支架之间的连接仅有一根细线，且下端与尿道支架上口的一侧相连，当膀胱括约肌处于收缩状态时，此连接细线无法保持直线状态，势必对膀胱括约肌产生持久的压、扎、勒、割的应力，久而久之，甚至能够嵌入膀胱颈肌肉里，无疑将给患者带来持续的疼痛、不适或异物感。
现有技术中国专利申请号92239852.6没有顾及膀胱括约肌的作用，当支架在物理作用撑开前列腺尿道的同时也撑开了膀胱括约肌，这使控制尿液的闸门仅剩尿道括约肌，极易造成病人漏尿或压力性尿失禁。
正是基于现有技术中的种种问题，致使目前医疗实际中至今没有形成真正能够广泛应用于临床的商用产品。因此，本领域技术人员深感需要有一种新型的前列腺支架以实现一种简单、有效、无创、价廉、痛苦小，可摘除、可重复的方法，用于有效地解决前列腺增生带来的病症和痛苦。
发明内容
本发明针对现有技术中前列腺支架的各种问题，并结合临床应用的安全、方便、有效和工业生产的可行、稳定，以及医学伦理和国家法规层面的许可而设计的。
生物安全性是医疗产品首要考虑的因素。本发明采用生物相容性好、安全性高的有机高分子材料或和金属合金材料经合理搭配、有机复合制成。多材共用，刚柔并济，相得益彰，可以完美发挥支架的预期设计效果。
本发明摒弃一般支架需要锚定结构或弹力扩张支撑定位依赖，拒绝嵌入组织内部的永久性在体思维，以减少患者的疼痛、不适或异物感。
所以本发明的总体思路是根据尿道的解剖学特征，顺应腔道自然空间，采用悬挂结构定位，自适应膀胱括约肌收缩、松弛的生理过程，不影响自主排尿和锁尿功能，和小尺度支架主体以降低病人不适和异物感的发明理念，使产品更加贴合组织，适从生理功能，减轻病人术后痛苦，增强临床应用中病人的顺应性和在体的舒适感。
根据上述思路，本发明将按其支架的功能作用分为上、中、下三个部分。其上部为悬挂结构，下部为前列腺支架主体，中部为悬挂结构与支架主体的过渡连接结构。
悬挂结构的功能在于支架主体的悬挂定位。在体时，位于尿道内口及其上方的膀胱腔内，承担并均匀分散下部支架主体本身的重力和排尿时尿液对支架主体的向下冲刷力，从而确保支架主体不会向下移位或滑脱。
将悬挂结构设计成旋涡状或倒圆锥形，选用柔性材料，可使其与尿道内口及周围的膀胱组织呈面-面嵌合，以减少膀胱颈部的局部刺激。
悬挂结构上口设一承力环，并具备一定的弹张性。承力环的弹张力可使悬挂结构充分舒展于膀胱内，并通过侧壁结构可使下部支架主体的重力和排尿时尿液的冲刷力均匀分散于承力环上，刚柔并济，可确保悬挂结构在体时姿态稳定。另一方面，承力环还具备一定的柔韧变形性，足以方便借助器械操作通过外尿道将其置入体内或取出体外。悬挂结构定位理念是本发明的关键创新技术所在。
为保证承力环的物理性能，可在其中复合添加其它异质材料的加强筋或弹力体。承力环也可以做成中空体，或薄壁管状体。后者使用前注入液体或气体，借助内压使其具备弹性和柔性。
悬挂结构旋涡形或锥形体的侧壁柔软薄弱，物理强度有限，容易撕裂，可在其中复合添加其它异质材料的加强筋、或在其表面附设条状或网纹结构以增强其抗撕裂强度。
为方便临床使用中将支架置入或取出时的器械操作，在悬挂结构涡形或锥形体侧壁上缘与承力环的交界处设置1个或多个镂孔，作为尿道介入器械的抓摄位点，以避免机械力的推拉作用导致悬挂结构侧壁的撕裂破损。为增强镂孔的抗撕裂强度，可将边缘加厚增强，并使镂孔的整体形状尽量圆滑。
支架主体是发挥其扩张尿道、疏通尿流等基本功能的主体结构，在物理构造上一个通道空间是不可或缺的，因此管状体结构是首选的物理形态，结合前列腺内尿道的解剖学特征，也可以选择中间彭大的纺锤形囊状体造型。
由于悬挂结构的存在，支架主体无需考虑锚定装置，从而可以极大地简化支架主体的物理结构。另外，为了尽可能减少支架在体时的刺激及植入后病人的异物感，需要在保证支架主体功能效用的前提下尽量减小其物理尺度的大小。这对于此前依赖扩张定位的支架是一种颠覆性的改进。
支架主体的外表面，可设置一些横向环状隆起，轴向分布在支架主体外表面，等距或不均匀，整体外观呈竹节状。环状隆起可以防止支架主体在尿道内频繁的小幅度滑动，对在体位置的锚定具有一定的帮助，但不起决定性作用。横向环状隆起的横截面呈平滑的类三角形或弓形。
支架主体管壁的支撑力是保持管道内腔通畅的基础，为了增强支架的基本支撑功能，在适当增加壁厚的同时可添加适宜刚弹力的加强筋，以达到支架主体具备足够而又恰当的刚性支撑力。
支架主体管壁中的加强筋可选用硬度更高的有机高分子材料，也可选用金属合金材料。加强筋可设计成螺旋形弹簧管状，旋距相等或不均匀；或为2个或多个互不连接的单环组合，轴向分布在管壁内，间距相等或不均匀排列。螺旋状弹簧管或是单环组合可以是等径的，也可以是不等径的。加强筋也可设计成各种图案和平面造型的网状管形体，网孔大小和形状可随材料与制作工艺而异。加强体可由金属材料或非金属材料制成，但应具备一定的柔软性和适度的刚性。加强体本身的设计和合适的相关参数是人体支架领域所熟知的。
悬挂结构与支架主体之间的过渡连接是本发明的另一关键创新技术。它是将悬挂结构与支架主体之间连接成整体的结构，其上端与悬挂结构的下口相连接，下端与支架主体的上口相连接。当支架置入人体后该连接结构位于膀胱括约肌处尿道(男性尿道三大狭部之一)，在功能上，既不能干扰膀胱括约肌的收缩，也不能干扰影响膀胱括约肌的舒张。膀胱括约肌的收缩与舒张分别对应着膀胱的锁尿功能和排尿功能，任何可能影响膀胱括约肌收缩和舒张的因素均可导致膀胱锁尿功能和排尿功能的失常。
针对这一技术关键，本发明采用如下措施以满足这一技术需求。首先选用超柔材料，其次采用超薄结构，再结合管状体物理设计，多措并举，从而达到既不会影响膀胱括约肌的收缩功能，也不会影响膀胱括约肌的舒张功能。最终避免由于支架的影响导致膀胱正常锁尿和自主排尿功能的失常。临床应用中，可以极大降低患者使用支架后漏尿和尿失禁特别是压力性尿失禁发生的风险，而且这种管状连接可以减少其对膀胱括约肌的局部刺激，消除病人术后不适。
基于过渡连接的超薄结构，可在其表面设置同质材料或在其壁中设置异质材料的加强筋，以增加其物理强度，但不能明显影响其功能的发挥。加强筋可制成条状，纵向分布，或呈网状。
这种悬挂式自适应前列腺支架，作为一个有机整体，刚柔并济，相得益彰。其中上部悬挂结构可与尿道内口及其附近的膀胱内壁紧密贴合，极大地减小支架在体时对膀胱内口的压迫和刺激。中部结构管壁超薄柔软，具有优异的柔韧性；在体时，位于膀胱括约肌狭部尿道，当膀胱括约肌随自主意识松弛时，中部结构可以在内部尿液压力下自然舒张，呈现管状结构，尿液在膀胱收缩压力下自管中流过，因而不影响自主排尿。排尿结束后，膀胱括约肌收缩，管状结构可随之闭合。这样便有效地解决现有技术在撑开前列腺尿道的同时也强行撑开了膀胱括约肌，导致膀胱括约肌不能闭合而造成漏尿甚至尿失禁特别是压力性尿失禁的问题。下部结构支架主体，相较于现有技术，管径小，不存在对尿道壁的扩张支撑锚定，因而可以避免支架在体时病人的持续疼痛、不适和异物感。加上支架主体的柔软、可弯曲特性，力求达到体内无感或微感。从而最大限度地增加病人的顺应性和舒适度。
可选地，本发明的新型支架可以进一步的用于作为一个方便的药物载体。前列腺尿道粘膜上皮细胞没有角质层，药物透皮容易迅速，透过率高，是前列腺疾病透皮给药最接近的部位。前列腺尿道穿行于前列腺中，药物透过粘膜上皮细胞后可以立即到达前列腺组织，直达病灶，是前列腺疾病透皮给药治疗最有前景的课题之一。
综上所述，本发明的主要技术特征概括为(1)采用悬挂结构为支架主体定位，其上口承力环和旋涡状或倒圆锥形造型又是实现悬挂结构特殊效果的重要细节；(2)中部的超薄连接结构，不会影响膀胱括约肌的正常生理功能；(3)支架主体摒弃其锚定结构，以最小尺度在体并发挥作用，可避免许多应用后遗症；以及(4)作为药物载体为前列腺疾病经尿道粘膜透皮给药治疗提供了有效方法。
附图说明
图1为一个实施例的立体示意图。
图2为一个实施例中的使用状态示意图。
图3为一个实施例的正视图。
图4为一个实施例中沿方向D的剖视图，D轴为所述前列腺支架整体的中心轴线。
其中：
1：悬挂结构；2：过渡连接结构；3：支架主体；4：加强筋。
具体实施方式
本发明悬挂式自适应前列腺支架整体由有机高分子材料与金属合金材料复合制成。有机高分子材料首选硅胶材料，金属合金材料首选钛合金或医用不锈钢。
如图1-4所示，所述的悬挂式自适应前列腺支架，按其结构可分为上、中、下三个部分。其上部为悬挂结构1，下部为前列腺支架主体3，中部为悬挂结构与支架主体的过渡连接结构2。
所述上部悬挂结构大体呈旋涡状或倒圆锥形，首选旋涡状；其上端开口直径3～50mm， 优化为5～30mm；下端开口直径1～15mm，优化为3～10mm；高3～50mm，优化为8～30mm；壁厚0.01～3mm，优化为0.05～2mm。
所述悬挂结构的上端开口边缘具承力环，其横切面为类圆形或类矩形或类半圆形，优选类圆形，直径0.5～8mm，优化为1～4mm。承力环可以是中空的，也可以是实心的，优选实心体。环体中可含有或不含加强筋，加强筋4可由1～多股金属合金材料或其它材料制成。优选不含加强筋。
所述的悬挂结构1，其涡状体或锥体侧壁表面或壁内可设置同质或异质材料制成的加强筋；优选为加强筋设置在表面，同质制造。加强筋4可呈条形或网格状，优选条形，1道或多道，纵向排列，位于悬挂结构的内侧表面；上端连接承力环下缘，下端至所述悬挂结构的下口。
进一步的，所述加强筋横截面为类三角形，宽、高分别为0.1～0.8mm，优选0.2～0.5mm。
所述的悬挂结构1，其承力环与涡状体或锥形体侧壁的交界处，亦即在承力环下缘的涡状体或锥形体侧壁上，具1～多个等距或不等距分布的镂孔，优化为1～4个，对称分布；镂孔类半圆形、或倒三角形，宽、高各0.5～5mm，优化为倒三角形，宽、高各2～4mm。镂孔边缘可适当加厚。
所述悬挂式自适应前列腺支架，其下部支架主体呈圆柱形管状或中部彭大的纺锤形囊状结构，优选为圆柱形管状。两端开敞。管体内径2～15mm，优选3～8mm；壁厚0.1～4mm，优选0.2～2mm，长10～100mm，优选2～80mm。
进一步的，所述的下部支架主体3的外表面具多个横向环状隆起。隆起环的横截面呈弓形，宽1～5mm，优选2～3mm，高0.1～2mm，优选0.2～1mm。
进一步的，所述的下部支架主体3的管壁中含有加强筋。加强筋呈螺旋形弹簧管状，或为各种图案和网状造型，或为2个或多个互不连接的单环组合，优选为螺旋形弹簧管状，旋距相等或不均匀，优选相等旋距，0.1～4mm，优选0.2～3mm，轴向分布在管壁内。加强筋的存在可以克服外部压力使支架主体维持通畅的管腔，其设计和参数可由本领域技术人员根据本发明的要求和具体实施例进行常规调整。
所述的一种悬挂式自适应前列腺支架的过渡连接结构2，为悬挂结构与支架主体的过渡连接，呈管状；上端与悬挂结构1的下口连接，下端与支架主体3的上口相连；长2～30mm，优化5～20mm；壁厚0.02～2mm，优化为0.05～1mm。中部过渡连接结构2的设计和参数可由本领域技术人员根据本发明的要求和具体实施例进行常规调整。一般原则是，其结构应该易于受膀胱括约肌的作用而处于闭塞状态，同时在解除膀胱括约肌作用时，易于受内部液体压力和其自身弹性的作用使内部空腔呈现舒张状态。
进一步的，所述的悬挂结构1与支架主体3的连接结构，其表面可设置条形或网格状加强筋。优选条形，1道或多道，纵向排列，位于过渡连接结构2管状体的内侧表面；上端与悬挂结构1侧壁内表面的加强筋无缝对接，下端与支架主体3的上端相连。
实施例一
设计
本实施例悬挂式自适应前列腺支架整体由有机高分子材料与金属合金材料复合制成。有机高分子材料选用硅胶材料，金属合金材料选用医用不锈钢。
本实施例悬挂式自适应前列腺支架，其上部悬挂结构1呈旋涡状，上口外径25mm，下口内径5mm，高13mm，壁厚0.3mm。
进一步地，上部悬挂结构的上口边缘设置承力环，承力环横切面为圆形，直径2.5mm。其旋涡状体侧壁设置3条加强筋。纵向等距排列，位于悬挂结构的内侧表面；上端连接承力环下缘，下端直达支架主体的上口，并止于对应支架主体外表面第一个横向环状隆起的中部。加强筋横截面呈类三角形，高0.2mm，底宽0.4mm。
本实施例悬挂式自适应前列腺支架，其下部支架主体3呈圆柱形管状结构，两端开敞；管体长46.5mm，内径5mm，壁厚0.5mm。
进一步的，下部支架主体3的外表面设置5个横向环状隆起。隆起横截面呈弓形，弦宽3mm，弦高0.5mm。支架主体3的管壁中设置加强筋，呈螺旋形弹簧管样。
本实施例悬挂式自适应前列腺支架，其中部结构2为上部悬挂结构与下部支架主体的过渡连接，呈管状；上端与悬挂结构的下口连接，下端与支架主体的上口相连；长12mm，内径5mm，壁厚0.2mm。其内表面具源自悬挂结构的加强筋4纵向穿过。
制作过程
设备与材料
模具：采用铝合金材料委托专门CNC企业精密加工制成。
硅胶：采用Momentive-Silopren LSR 2003液体硅橡胶，其质量符合ISO 10993和USP Class VI的要求。
不锈钢螺旋弹簧管：长42.5mm，内径5.2mm。采用SUS316LVM不锈钢丝，直径0.2286mm。旋距0.75mm。委托专门工业弹簧生产企业加工制作。
白凡士林：符合《中国药典》(2020年版)规定。
医用注射器：符合有关法规规定。
工艺方法
本实施例悬挂式自适应前列腺支架采用注塑工艺、模具内一次整体成型的方法制作。
不锈钢螺旋弹簧管以家用厨房洗洁精洗净，自来水汰涤至无泡沫，去离子水终洗，150℃干燥30min。
打开模具，清洁内部表面，并擦试白凡士林作为脱模剂，置入螺旋形弹簧管，扣合模具，夹紧固定备用。
分别称取液体硅橡胶A、B，按1∶1比例等量混合，搅拌均匀，真空脱气。用注射器吸取适量，排除气泡，缓缓注入模具至溢流口有少量硅胶流出。180℃固化3分钟。脱模，整理，即得。
实施例二
本实施例二悬挂式自适应前列腺支架，同实施例一。其上部悬挂结构1上口外径28 mm，下口内径5.5mm。承力环横切面直径3mm。悬挂结构1设置镂孔4个，并相应形成4条加强筋4。
本实施例二下部支架主体长55mm，内径5.5mm，外表面设6个横向环状隆起。壁内螺旋弹簧管长51mm，内径5.7mm；
本实施例悬挂式自适应前列腺支架，其中部过渡连接结构2管状体长14mm，内径5.5mm。
临床使用方法
将本悬挂式自适应前列腺支架压置于专用导管中，借助导管经外尿道口送到膀胱内口处，撤出导管，并同时释放支架进入前列腺，在膀胱内镜下检查支架的位置与姿态是否恰当，并可用异物钳进行调整至合适。
亦可利用膀胱内镜及专用异物钳将本支架取出体外。操作时将膀胱内镜插入尿道，并穿过支架主体的内腔进入膀胱口。操作膀胱内镜和专用异物钳，将钳嘴夹住悬挂结构的承力环，缓缓拉动承力环，使悬挂结构1的一侧拉向膀胱口，由于悬挂结构1的整体都是柔软的，此时的承力环连同整个悬挂结构即呈折叠状。缓缓外撤膀胱内镜，折叠变形的承力环连同整个悬挂结构，在异物钳的牵引下，即可通过膀胱口进入尿道。当达到支架主体的上端时，由于形成折叠的承力环其空间尺寸大于支架主体的内腔，故折叠的承力环不能进入支架主体内腔；随着膀胱镜的回撤，异物钳对承力环的牵拉力将带动支架主体沿着尿道向下滑动。直到完全退出膀胱镜，从而取出整个前列腺支架。
有益效果：
一、关于悬挂结构
在现有公开资料中，前列腺支架多是依靠其本身强力的径向弹性扩张、膨胀支撑于尿道内壁进行最初的锚定定位，这种锚定方式会给患者带来出血、持续的疼痛、刺激、不适或异物感。另外，对于金属支架或因上皮细胞的生长与包埋不可随意更换，若要取出，必需手术切开尿道上皮组织方可如愿，且不能立即放置新的支架。而覆膜支架则存在置入后移位、甚至滑脱的可能，也可因支架的长期挤压造成尿道周围乃至前列腺部分组织缺血坏死等诸多风险。
为了克服这些问题，本发明摒弃弹力扩张支撑定位思维，根据男性尿道的解剖学特征，顺应腔道自然空间，采用悬挂结构定位，从而大大降低支架主体的物理尺度，进而降低或消除病人置入支架后的疼痛、不适或异物感。悬挂结构1卡嵌在尿道内口及其上方的膀胱腔内，承担并均匀分散下部支架主体3的重力和排尿时尿液对支架主体的向下冲刷力，从而确保支架主体不会向下移位或滑脱。
悬挂结构1呈旋涡状或倒三角状，以柔性材料制造，可使其与尿道内口及周围的膀胱组织呈面-面嵌合，以减少膀胱颈部的局部刺激。悬挂结构1的弹性承力环可使悬挂结构1充分舒展于膀胱内，如此刚柔并济，可确保悬挂结构1在体时姿态稳定。另一方面，弹性承力环还具备一定的柔韧变形性，足以方便借助器械操作通过外尿道将其置入体内或取出体外。
二、关于膀胱括约肌自适应结构
正常男性在自主意识下的排尿过程受控于上括约肌和下括约肌二道屏障，上括约肌即膀胱括约肌，下括约肌即尿道括约肌。在正常的生理状态下，上、下括约肌均呈收缩状态，将膀胱中的尿液完全锁住，只有在排尿时，上下括约肌在自主意识的控制下同时松弛，尿道的两道闸门全部打开，同时膀胱逼尿肌收缩，尿液在膀胱逼尿肌收缩压力下得以通过尿道并排出体外。排完尿液后膀胱逼尿肌松弛，尿道上下括约肌同时恢复收缩状态。所以在正常状态下，膀胱中的尿液不会通过尿道不自主地流出体外。当存在某种外力如医疗器械，或因手术损伤如前列腺切除术，或因某种疾病造成尿道括约肌或某一括约肌收缩不全，就可导致尿失禁、漏尿、或压力性尿失禁。
膀胱括约肌是人体锁住膀胱尿液的第一道屏障，当患者植入不具备膀胱括约肌自适应支架或器械时，在该支架或器械的物理作用下机械地撑开了膀胱括约肌及其尿道内口，使膀胱与前列腺尿道之间的“闸门”即尿道内口被强行打开，膀胱括约肌的基本生理功能被解除，锁住尿液的第一道屏障也随之丧失，因而人体控制尿液的“重担”就全部落在了尿道括约肌上，由于失去了一道“闸门”，人体的自主锁尿功能将大打折扣，所以临床上可表现出漏尿、尿失禁，尤其是压力性尿失禁等术后病态症状。
本发明在对应于膀胱括约肌处即前列腺支架主体与附属装置之间设置了一个薄壁柔软富有弹性的管状连接结构，使其能够顺应膀胱括约肌的舒张和收缩功能，随尿道内口的张合而随之开闭，无疑是保留患者正常的生理锁尿机能，避免应用不适支架后出现漏尿或尿失禁等不良反应的最有效的措施。
本发明契合人体腔道的解剖学特点，可充分避免对患者膀胱括约肌功能的影响，从而避免植入支架后所致的不良后果。
三、关于支架主体3
正是有了悬挂结构，支架主体的小尺度构造方能得以实现。然而，这一设计虽然消除了大尺度支架带来的支撑痛苦，但小尺度构造有可能导致支架主体在轻微外力如提肛动作等生理性力量的作用下于前列腺内的小幅度纵向自由滑动，为了消除这一隐患，本发明在支架主体的外表面设置有隆起的横向环形结构，可防止支架主体在前列腺内纵向小幅自由滑动的同时，对其整体的锚定定位也有一定的协同效果。
四、作为药物载体
局部经皮给药具有无首过效应，用药剂量小，给药部位组织中药物浓度高，无全身作用，毒副作用小，临床疗效高，患者顺应性好等诸多收益。
五、临床试用效果
试用患者4例，效果统计如下：

以上理论阐述和实施例描述并指出了应用本发明的根本性新颖特征，但应理解的是，本领域技术人员可以在不背离本发明精神的情况下对所示实施例的形式和细节进行各种省略、替换和改变。本发明不受上述理论阐述的束缚，也不限于上述仅作为示例的实施例，而是可以在所附专利权利要求限定的保护范围内以各种方式进行修改。还应理解的是，即使不参考所示具体实施例，也可以实践本发明，因为本发明的本质不在于技术难度或复杂性，而在于新颖的理念本身。一旦权利要求中所述的理念为人所知，其实践就属于本领域的普通技术范围。

Claims (15)

  1. 一种悬挂式自适应前列腺支架，其特征在于，总体呈倒喇叭形管状体，两端开口、管腔通畅，包括上、中、下三个部分；其中上部为悬挂结构，其有一个上端开口和一个下端开口，且上端开口的直径至少是下端开口直径的2倍；下部为前列腺支架主体，其有一个上端开口和一个下端开口；中部为连接所述悬挂结构与所述支架主体的过渡连接结构，其有一个上端开口和一个下端开口；所述过渡连接结构的上端开口与所述悬挂结构的下端开口相连，而所述过渡连接结构的下端开口与所述支架主体的上端开口相连。
  2. 根据权利要求1所述的前列腺支架，其特征在于，其中所述悬挂结构呈旋涡状或倒圆锥形，上端开口直径3～50mm，下端开口直径1～15mm，高3～50mm。
  3. 根据权利要求1所述的前列腺支架，其特征在于，其中所述悬挂结构的上端开口边缘设有承力环，所述承力环的横切面为类圆形或类矩形或椭圆形或半圆形，可以是实心的，也可以是中空的，所述承力环的外径0.5～8mm。
  4. 根据权利要求3所述的前列腺支架，其特征在于，其中所述承力环中设有加强筋，所述加强筋可以由金属或其它材料制成，其物理性能可以是柔软的，也可以具有一定的弹张性能。
  5. 根据权利要求2所述的前列腺支架，其特征在于，其中所述悬挂结构的壁厚为0.05～3mm，其表面或壁中可设置同质或异质材料制成的加强筋。
  6. 根据权利要求5所述的前列腺支架，其特征在于，其中所述悬挂结构的壁的上缘与承力环交界处设置若干镂孔，镂孔类三角形，或类半圆形，宽高或直径各0.5～5mm，镂孔边缘可以加厚增强。
  7. 根据权利要求1所述的前列腺支架，其特征在于，其中所述支架主体呈管状或中部彭大的纺锤形囊状，两端开敞；管体或囊腔内径2～15mm；壁厚0.1～4mm，长10～100mm。
  8. 根据权利要求1所述的前列腺支架，其特征在于，其中所述支架主体的外表面设若干横向环状隆起，轴向分布。
  9. 根据权利要求7所述的前列腺支架，其特征在于，其中所述支架主体的管壁或囊壁内设置抗压加强筋。
  10. 根据权利要求9所述的前列腺支架，其特征在于，其中所述抗压加强筋可为螺旋形弹簧样管状体，旋距相等或不均匀；或可为2个或多个互不连接的单环组合，等径或不等径、均匀或不等距地轴向分布在管壁或囊壁中；所述抗压加强筋也可以为网状管形体；所述抗压加强筋可由金属材料或非金属材料制成。
  11. 根据权利要求1所述的前列腺支架，其特征在于，其中所述过渡连接结构呈管状，其长度2～30mm，壁厚0.02～2mm。
  12. 根据权利要求1所述的前列腺支架，其特征在于，其中所述过渡连接结构的表面或壁中可设置同质或异质材料制成的加强筋。
  13. 根据权利要求1所述的前列腺支架，由有机高分子材料、或有机高分子材料与金属材料复合制成。
  14. 根据权利要求1所述的前列腺支架用于前列腺疾病患者导尿的用途。
  15. 根据权利要求1所述的前列腺支架用于前列腺疾病经尿道透皮给药系统作为载体的用途。
PCT/CN2024/115021 2023-08-30 2024-08-28 一种悬挂式自适应前列腺支架 WO2025045068A1 (zh)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202322340777.XU CN221130121U (zh) 2023-08-30 2023-08-30 一种悬挂式前列腺支架及前列腺部尿道粘膜透皮给药载体
CN202322340777.X 2023-08-30
CN202323136447.5 2023-11-21
CN202323136447.5U CN221750949U (zh) 2023-11-21 2023-11-21 一种前列腺支架的膀胱括约肌自适应结构

Publications (1)

Publication Number Publication Date
WO2025045068A1 true WO2025045068A1 (zh) 2025-03-06

Family

ID=94818180

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2024/115021 WO2025045068A1 (zh) 2023-08-30 2024-08-28 一种悬挂式自适应前列腺支架

Country Status (1)

Country Link
WO (1) WO2025045068A1 (zh)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5059169A (en) * 1989-07-07 1991-10-22 C. R. Bard, Inc. High-friction prostatic stent
CN2143120Y (zh) * 1992-11-02 1993-10-06 宋乐明 前列腺尿道支架
US20020072788A1 (en) * 2000-02-03 2002-06-13 Hammond Gaines W. Facilitating drainage
US20090156977A1 (en) * 2007-12-12 2009-06-18 Boston Scientific Scimed, Inc. Urinary stent
US20100241240A1 (en) * 2005-06-20 2010-09-23 Abbeymoor Medical, Inc. Self-adjusting endourethral device & methods of use
US8465551B1 (en) * 2011-07-09 2013-06-18 Bandula Wijay Temporary prostatic stent for benign prostatic hyperplasia
CN107648720A (zh) * 2016-07-26 2018-02-02 北京万生人和科技有限公司 一种内置式导尿管
CN110691564A (zh) * 2017-04-04 2020-01-14 马德琳·拉姆斯泰特 尿道装置
CN113967305A (zh) * 2021-12-22 2022-01-25 德宝恒生科技服务有限公司 一种排尿管
CN221130121U (zh) * 2023-08-30 2024-06-14 王伯涛 一种悬挂式前列腺支架及前列腺部尿道粘膜透皮给药载体

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5059169A (en) * 1989-07-07 1991-10-22 C. R. Bard, Inc. High-friction prostatic stent
CN2143120Y (zh) * 1992-11-02 1993-10-06 宋乐明 前列腺尿道支架
US20020072788A1 (en) * 2000-02-03 2002-06-13 Hammond Gaines W. Facilitating drainage
US20100241240A1 (en) * 2005-06-20 2010-09-23 Abbeymoor Medical, Inc. Self-adjusting endourethral device & methods of use
US20090156977A1 (en) * 2007-12-12 2009-06-18 Boston Scientific Scimed, Inc. Urinary stent
US8465551B1 (en) * 2011-07-09 2013-06-18 Bandula Wijay Temporary prostatic stent for benign prostatic hyperplasia
CN107648720A (zh) * 2016-07-26 2018-02-02 北京万生人和科技有限公司 一种内置式导尿管
CN110691564A (zh) * 2017-04-04 2020-01-14 马德琳·拉姆斯泰特 尿道装置
CN113967305A (zh) * 2021-12-22 2022-01-25 德宝恒生科技服务有限公司 一种排尿管
CN221130121U (zh) * 2023-08-30 2024-06-14 王伯涛 一种悬挂式前列腺支架及前列腺部尿道粘膜透皮给药载体

Similar Documents

Publication Publication Date Title
US8887731B2 (en) Pessary device
JP2005504558A (ja) 尿道内で用いる装置及びその方法
WO2009152609A1 (en) Catheter device for the control of liquid discharge from the urinary bladder by a user person
US20160135942A1 (en) Urinary flow control device and method
CN107670160A (zh) 防止拔出时破坏周围组织的引流管
JP5318925B2 (ja) 尿道カテーテル
EP2648642B1 (en) Medical device for the prevention and/or correction of phimosis through the static progressive dilatation of scar ring
JP7216712B2 (ja) 尿失禁治療のための尿道プラグおよびシステム
CN221130121U (zh) 一种悬挂式前列腺支架及前列腺部尿道粘膜透皮给药载体
WO2025045068A1 (zh) 一种悬挂式自适应前列腺支架
CN110025423B (zh) 一种肠袢式造口支架和用该肠袢式造口支架的造口袋
CN210205560U (zh) 一种男性内置隐藏式导尿管
CN105877870A (zh) 治疗男性尿失禁的新型尿道夹
CN221750949U (zh) 一种前列腺支架的膀胱括约肌自适应结构
CN110478082A (zh) 隐形男性尿道夹及其使用方法
CN214970992U (zh) 一种新型辅助导尿的尿道扩张器
CN204972651U (zh) 一种防堵塞侧球囊导尿管
CN211356073U (zh) 隐形男性尿道夹
JP2014531251A (ja) 膀胱内に尿道を配置するように構成された失禁治療装置
CN221637084U (zh) 一种具有牵拉冲洗功能的前列腺导尿管
US20100010478A1 (en) Intraurethral catheter
CN210728395U (zh) 一种导尿鞘
CN216258673U (zh) 一种导尿管辅助置入装置
CN221751963U (zh) 一种负载药物的导尿管
CN215084009U (zh) 一种新型易留置三腔导尿管