Balloon dilatation catheter for prostatic hyperplasia

Abstract

The utility model relates to the technical field of medical instruments, in particular to a balloon dilatation catheter for benign prostatic hyperplasia, which comprises a limiting balloon, a dilatation balloon, a catheter and a seat body, the catheter comprises an inner tube, a filling tube, a tube body and an outer tube, the seat body comprises a dilatation balloon filling seat, a limiting balloon filling seat and a guide wire cavity seat which are integrally formed, and the dilatation balloon filling seat and the limiting balloon filling seat are arranged on the outer tube. The seat body is connected with one end of the tube body, the filling tube is arranged in the tube body, one end of the filling tube is communicated with the limiting balloon, the other end of the filling tube is communicated with the limiting balloon filling seat, the inner tube is arranged in the tube body, one end of the inner tube is connected with the limiting balloon, the other end of the inner tube is communicated with the guide wire cavity seat, and the tube body is connected with the limiting balloon. One end, close to the limiting balloon, of the tube body is connected with the dilatation balloon, the other end of the tube body is communicated with the dilatation balloon filling seat, and an outer tube wraps the portion, between the dilatation balloon and the seat body, of the tube body.

Description

Technical Field

[0001] The utility model relates to the technical field of medical devices, and specifically relates to a balloon dilation catheter for benign prostatic hyperplasia. Background Art

[0002] Benign prostatic hyperplasia (BPH) is a common disease among middle-aged and elderly men. The hyperplastic prostate compresses the urethra or affects the obstruction of the bladder urethral orifice, resulting in a series of micturition disorder symptoms. Benign prostatic hyperplasia (BPH) is mainly related to the age of men. With the increase of age, the incidence of BPH will increase significantly. For men over 50 years old, the incidence of benign prostatic hyperplasia is about 50%; for those over 80 years old, the incidence is >90%. The age is directly proportional to the incidence of BPH. It is estimated that by the end of 2035, the revenue of the global BPH prostate treatment market will reach $13 billion, with a compound annual growth rate of about 6% during the forecast period (i.e., from 2023 to 2035). With the intensification of the global population aging, the BPH market has also attracted the attention of more and more medical device manufacturers.

[0003] The main treatment methods for benign prostatic hyperplasia include drug treatment, surgical treatment, and minimally invasive treatment. Among them, for drug treatment, drugs such as 5α-reductase inhibitors and α1-receptor blockers are often used to relieve and delay the disease. However, the drugs have large side effects, including dizziness, sexual dysfunction, etc., and need to be taken for a long time. They are often used for prevention and relief and cannot completely cure the disease. Surgical treatments, such as transurethral resection of the prostate, transurethral prostate incision, open prostatectomy, etc., are invasive surgeries and may cause various complications, such as urinary incontinence, retrograde ejaculation, fluid overload syndrome, impotence, etc. Minimally invasive treatment is a new treatment method developed in the medical field in recent years and represents a new direction in medicine. Typical treatment methods include the Rezum prostate hot steam treatment device of Boston Scientific, the UroLift PUL prostate staple system of Teleflex, the iTind nitinol stent system of OLYMPUS, and balloon dilation catheters. However, Rezum is an active device that needs to be used in combination with equipment, and hot steam needs to be injected during use. The prostate staples and stents are implantable devices with high risks. The balloon dilation catheter dilates the prostate stenosis area through a simple balloon, but has a high restenosis rate. Content of the Utility Model

[0004] Aiming at the deficiencies of the existing technology, the purpose of the utility model is to provide a long-term effective balloon dilation catheter for benign prostatic hyperplasia to inhibit tissue hyperplasia in the hyperplastic prostate area and maintain long-term patency of the urethra.

[0005] To achieve the above object, the present utility model provides the following technical solutions: A balloon dilation catheter for benign prostatic hyperplasia, comprising a limiting balloon, a dilation balloon, a catheter, and a seat body,

[0006] The catheter includes an inner tube, a filling tube, a tube body, and an outer tube,

[0007] The seat body includes a dilation balloon filling seat, a limiting balloon filling seat, and a guide wire cavity seat which are integrally formed. The seat body is connected to one end of the tube body,

[0008] The filling tube is placed inside the tube body, and one end of the filling tube is communicated with the limiting balloon, and the other end is communicated with the limiting balloon filling seat,

[0009] The inner tube is placed inside the tube body, and one end of the inner tube is connected to the limiting balloon, and the other end is communicated with the guide wire cavity seat,

[0010] The tube body is connected to the limiting balloon, and one end of the tube body close to the limiting balloon is connected to the dilation balloon. The other end of the tube body is communicated with the dilation balloon filling seat,

[0011] An outer tube is coated on the tube body between the dilation balloon and the seat body.

[0012] In some embodiments, a fixing member for fixing the inner tube and the filling tube is provided at the end of the tube body where the limiting balloon is located.

[0013] In some embodiments, the limiting balloon is a compliant bladder.

[0014] In some embodiments, the dilation balloon is a semi-compliant or non-compliant bladder.

[0015] In some embodiments, a drug coating is coated on the outer surface of the dilation balloon.

[0016] In some embodiments, the material of the limiting balloon is silicone, latex, PU or PVC.

[0017] In some embodiments, the material of the dilation balloon is Pebax, nylon, PVC or PET.

[0018] In some embodiments, the material of the inner tube is PA, PE, Pebax or PI, and the material of the filling tube is PA, PE, Pebax or PI.

[0019] In some embodiments, cutting slits are distributed on the tube body. The angular range of the cutting slits corresponding to the area covered by the dilation balloon on the tube body is 70° - 90°; the angular range of the cutting slits in other areas of the tube body is 85° - 90°, and the width range of the cutting slits is 0.005mm - 0.5mm.

[0020] In some embodiments, the drug material of the drug coating is an anti-proliferative drug.

[0021] Compared with the prior art, the beneficial effect of the utility model is that through the cooperation of the expansion balloon, the drug coating and the limiting balloon, after the expansion balloon is filled and expanded to expand the narrow area of ​​the prostate, the drug is transferred to the diseased tissue, which can effectively inhibit cell proliferation and maintain long-term continuous urethra patency.

[0022] Details of one or more embodiments of the present application are presented in the following drawings and descriptions to make other features, purposes and advantages of the present application more concise and easy to understand. The present application is fully described and understood through the embodiments of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 It is a schematic diagram of the structure of the utility model;

[0024] Figure 2 It is a cross-sectional view of the tube body of the utility model;

[0025] Figure 3 Diagram of the state of the prostate gland during insertion of a catheter for prostate dilation;

[0026] Figure 4 It is a state diagram of the limited balloon expansion;

[0027] Figure 5 This is a state diagram of the dilation balloon expansion;

[0028] Figure 6 It is the state when it is taken out after use.

[0029] In the figure: 1. limiting balloon; 2. inner tube; 3. fixing piece; 4. filling tube; 5. expansion balloon; 6. outer tube; 7. tube body; 8. stress protection tube; 9. expansion balloon filling seat; 10. limiting balloon filling seat; 11. guide wire cavity seat. DETAILED DESCRIPTION

[0030] The following will be combined with the drawings in the embodiments of the utility model to clearly and completely describe the technical solutions in the embodiments of the utility model. Obviously, the described embodiments are only part of the embodiments of the utility model, not all of the embodiments. Based on the embodiments in the utility model, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model. Example

[0031] See also Figures 1-6 The utility model provides a technical solution: a balloon dilatation catheter for prostate hyperplasia, comprising a limiting balloon, a dilatation balloon, a catheter and a seat body.

[0032] The catheter includes an inner tube, a filling tube, a tube body, and an outer tube.

[0033] The seat body includes an integrally formed dilation balloon filling seat, a limiting balloon filling seat, and a guide wire cavity seat. The seat body is connected to one end of the tube body through a stress protection tube.

[0034] The filling tube is placed inside the tube body, and one end of the filling tube is communicated with the limiting balloon, and the other end is communicated with the limiting balloon filling seat.

[0035] The inner tube is placed inside the tube body, and one end of the inner tube is connected to the limiting balloon, and the other end is communicated with the guide wire cavity seat.

[0036] The tube body is connected to the limiting balloon, and one end of the tube body close to the limiting balloon is connected to the dilation balloon. The other end of the tube body is communicated with the dilation balloon filling seat.

[0037] An outer tube is coated on the tube body between the dilation balloon and the seat body.

[0038] A fixing member for fixing the inner tube and the filling tube is arranged at the limiting balloon end inside the tube body. The material of the fixing member is PC, ABS or PE.

[0039] One end of the filling tube is placed inside the tube body through the fixing member in the distal tube body and is communicated with the limiting balloon. The other end is fixed to the limiting balloon filling seat. The filling and pressure relief of the limiting balloon are realized through this filling seat.

[0040] One end of the inner tube is placed inside the distal tube body through the fixing member and is welded to the distal end of the limiting balloon. The other end is fixed inside the guide wire cavity seat. The advancement of the product in the body is guided through the guide wire in the guide wire cavity seat and the inner tube.

[0041] The limiting balloon is a compliant balloon body, and the material of the limiting balloon is silicone, latex, PU or PVC.

[0042] The dilation balloon is a semi-compliant or non-compliant balloon body, and the material of the dilation balloon is Pebax, nylon, PVC or PET.

[0043] A drug coating is coated on the outer surface of the dilation balloon. The drug material of the drug coating is an anti-proliferative drug such as paclitaxel or rapamycin.

[0044] The material of the inner tube is PA, PE, Pebax or PI, and the material of the filling tube is PA, PE, Pebax or PI.

[0045] The material of the tube body is stainless steel or nitinol alloy.

[0046] Cutting slits are distributed on the tube body. The angular range of the cutting slits corresponding to the area covered by the dilation balloon on the tube body is 70° to 90°; the angular range of the cutting slits in other areas of the tube body is 85° to 90°, and the width range of the cutting slits is 0.005 mm to 0.5 mm.

[0047] The distal end of the tube body is welded to the proximal end of the limiting balloon and is also welded to the dilation balloon. An outer tube is coated from the proximal end of the self-expanding balloon to the seat body. The tube body adjusts its flexibility through the cutting slits distributed on it, and the dilation balloon is filled and depressurized through the cutting slits.

[0048] After the dilation balloon is filled and expands the prostate stenosis area, when the drug is transferred to the diseased tissue, it can effectively inhibit cell proliferation and keep the urethra unobstructed for a long time.

[0049] Through this technical solution, the use process of the prostate dilation catheter is as Figures 3-6 shown. The prostate dilation catheter enters the prostate along the guide wire pre-implanted in the body, and the limiting balloon extends into the bladder; the limiting balloon is filled through the limiting balloon filling seat. After the filling is completed, the tube body of the prostate dilation catheter is pulled back until obvious resistance is encountered. At this time, the limiting balloon is stuck at the internal sphincter; the dilation balloon is filled through the dilation balloon filling seat to completely expand the prostate stenosis area (the balloon dilation area is between the internal sphincter and the external sphincter). While expanding, the drug coated on the balloon penetrates into the prostate tissue.

[0050] The above embodiments only represent several implementation manners of the present application, and the description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several deformations and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

[0051] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principle and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A balloon dilatation catheter for prostate hyperplasia, characterized in that: It includes a limiting balloon, an expansion balloon, a catheter and a seat body. The catheter comprises an inner tube, a filling tube, a tube body, and an outer tube. The seat body includes an expansion balloon filling seat, a limiting balloon filling seat, and a guide wire cavity seat which are integrally formed, and the seat body is connected to one end of the tube body. The filling tube is placed in the tube body, and one end of the filling tube is connected to the limiting balloon, and the other end is connected to the limiting balloon filling seat. The inner tube is placed in the tube body, and one end of the inner tube is connected to the limiting balloon, and the other end is connected to the guide wire cavity seat. The tube body is connected to the limiting balloon, and one end of the tube body close to the limiting balloon is connected to the expansion balloon, and the other end of the tube body is connected to the expansion balloon filling seat. The tube body is covered with an outer tube between the expansion balloon and the seat body.

2. A balloon dilatation catheter for prostate hyperplasia according to claim 1, characterized in that: A fixing piece for fixing the inner tube and the filling tube is arranged in the tube body at the end of the limiting balloon.

3. A balloon dilatation catheter for prostate hyperplasia according to claim 1, characterized in that: The limiting balloon is a compliant balloon.

4. A balloon dilatation catheter for prostate hyperplasia according to claim 1, characterized in that: The expansion balloon is a semi-compliant or non-compliant balloon.

5. A balloon dilatation catheter for prostate hyperplasia according to claim 1 or 4, characterized in that: The balloon body of the dilatation balloon is coated with a drug coating.

6. A balloon dilatation catheter for prostate hyperplasia according to claim 3, characterized in that: The limiting balloon is made of silicone, latex, PU or PVC.

7. A balloon dilatation catheter for prostate hyperplasia according to claim 4, characterized in that: The expansion balloon is made of Pebax, nylon, PVC or PET.

8. The balloon dilatation catheter for prostate hyperplasia according to claim 1, characterized in that: The inner tube is made of PA, PE, Pebax or PI, and the filling tube is made of PA, PE, Pebax or PI.

9. A balloon dilatation catheter for prostate hyperplasia according to claim 1, characterized in that: The tube body is provided with cutting slits, and the angle range of the cutting slits on the tube body corresponding to the area covered by the expansion balloon is 70°~90°; the angle range of the cutting slits in other areas of the tube body is 85°~90°, and the width range of the cutting slits is 0.005mm~0.5mm.

10. The balloon dilatation catheter for prostate hyperplasia according to claim 5, characterized in that: The drug material of the drug coating is an anti-proliferative drug.

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