Balloon assembly for dosing prostate

Abstract

The utility model provides a balloon assembly for dosing prostate, which comprises a balloon catheter, a positioning balloon fixedly arranged at the far end of the balloon catheter, and an olive-shaped balloon adjacent to the positioning balloon and fixedly arranged on the balloon catheter, a pharmaceutical composition layer is arranged on the outer surface of the olive-shaped balloon, and the positioning balloon is fixedly arranged on the balloon catheter. The positioning balloon is used for being arranged in the bladder of a patient and used for positioning the balloon catheter, and the olive-shaped balloon is used for being arranged in the prostate of the patient and used for expanding and dosing the prostate by making contact with the inner wall of the prostate. Wherein the positioning balloon and the olive-shaped balloon are both non-compliant balloons or low-compliant balloons. The balloon assembly is combined with an existing instrument to treat prostate diseases, the narrow urethra of the benign hyperplasia section of the prostate can be safely expanded, restenosis of the urinary tract is reduced, and the purpose that a patient normally urinates is achieved.

Description

Technical Field

[0001] The invention relates to the field of medical technology, in particular to a balloon component for administering medicine to the prostate. Background Art

[0002] Prostatic hyperplasia is one of the common diseases in middle-aged and elderly men, and the incidence is increasing with the aging of the global population. Its symptoms include frequent urination, urgency, waiting to urinate, difficulty urinating, prolonged urination time, and a series of other symptoms. Currently common surgical methods include: transurethral resection of the prostate (TURP), transurethral prostatic urethral dilation (Urolift), transurethral thermal ablation, etc. However, there are many problems that need to be overcome with today's surgical methods, such as: long operation time, long hospitalization time after surgery, heavy bleeding during surgery, a series of complications during surgery, etc. Patients often need multiple surgeries to ensure normal urination. Utility Model Content

[0003] The prostate drug balloon assembly is a new technology. This technology uses paclitaxel or other drugs to apply on the surface of a special balloon, and then inserts the balloon into the patient's bladder and prostate through the urethra. After full expansion, it eliminates the urethral stenosis of the prostate hyperplasia part, and can inhibit the proliferation of paclitaxel to prevent the prostate from proliferating again, leading to restenosis of the urethra, so that patients can urinate normally. Using the prostate balloon assembly as a device to solve the problem of prostate stenosis is a new and safe treatment method.

[0004] The present application discloses a drug-delivery balloon assembly, which uses a balloon surface coated with medicine and is placed in the prostate and bladder through the urethra to treat prostate hypertrophy and solve the problem of urination difficulties.

[0005] The technical solution disclosed in this application includes the following implementation methods:

[0006] Embodiment 1: A prostate drug delivery balloon assembly containing an olive-shaped balloon, also referred to as a balloon assembly for delivering drug to the prostate, comprising:

[0007] A balloon catheter, a positioning balloon fixedly arranged at the distal end of the balloon catheter, and an olive-shaped balloon adjacent to the positioning balloon and fixedly arranged on the balloon catheter.

[0008] A drug composition layer is disposed on the outer surface of the olive-shaped balloon,

[0009] The positioning balloon is used to be placed in the patient's bladder to position the balloon catheter, and the olive-shaped balloon is used to be placed in the patient's prostate to dilate and administer drugs to the prostate by contacting the inner wall of the prostate.

[0010] Wherein the positioning balloon and the olive-shaped balloon are both non-compliant balloons or low-compliant balloons.

[0011] In the present application, the term "olive-shaped balloon" refers to a "drug administration balloon" that is accommodated in the prostatic urethra and used to contact-drug administration to the prostate. Therefore, the term "olive-shaped balloon" in the present application has the same meaning as the term "drug administration balloon", both of which refer to a balloon adjacent to the positioning balloon, which is olive-shaped, with a drug composition disposed on its outer surface, and is used to contact-drug administration to the prostate by being accommodated in the prostatic urethra.

[0012] Embodiment 2: The balloon assembly according to embodiment 1, further comprising a balloon connecting portion disposed between the positioning balloon and the olive-shaped balloon, wherein the outer diameter of the balloon connecting portion is smaller than the outer diameters of the positioning balloon and the olive-shaped balloon.

[0013] Embodiment 3: The balloon assembly according to embodiment 1, further comprising a sheath for accommodating the positioning balloon, the olive-shaped balloon and the corresponding balloon catheter, so that the positioning balloon and the olive-shaped balloon can reciprocate in the sheath, and the outer diameter of the sheath is 2 mm to 10 mm, preferably 4 mm to 8 mm, or 5 mm to 7 mm.

[0014] Embodiment 4: A balloon assembly according to embodiment 2, wherein the balloon connecting portion is non-compliant or has low compliance.

[0015] Embodiment 5: According to the balloon assembly described in embodiment 1, the positioning balloon and the olive-shaped balloon are directly connected, and there is no balloon connection portion between the two balloons. In this application, the term "balloon connection portion" is also referred to as "balloon neck", and the two terms have the same meaning and can be used interchangeably, both referring to a connection portion that may exist between the two balloons, and the connection portion is neither a positioning balloon nor an olive-shaped balloon in shape.

[0016] Embodiment 6: The balloon assembly according to embodiment 1, wherein the longitudinal sections of the outer surfaces of the positioning balloon and the olive-shaped balloon independently have convex arc-shaped contours at the ends.

[0017] Embodiment 7: According to the balloon assembly of embodiment 1, the longitudinal sections of the outer surfaces of the positioning balloon and the olive-shaped balloon independently form an angle of 30 to 50 degrees with the balloon catheter at the end.

[0018] Embodiment 8: The balloon assembly according to embodiment 1, wherein the drug composition layer contains at least one of paclitaxel and rapamycin, and an optional drug carrier.

[0019] Embodiment 9, according to any one of embodiments 1-7, wherein the radial dimensions of the positioning balloon and the olive-shaped balloon when expanded are independently 6-40 mm, such as 10 to 35 mm, such as 12 to 30 mm, such as 15 to 25 mm, such as 16 to 23 mm.

[0020] When a prostate drug delivery balloon assembly containing an olive-shaped balloon in the above embodiment is used to treat prostate hyperplasia, the operation can be completed by only making the olive-shaped balloon in the balloon assembly contact and expand the urethra wrapped in the prostate (also called prostate urethra), and the treatment process is simple and safe. The drug delivery balloon is set to an olive shape, which matches the shape of the prostate urethra in a healthy state, so that the prostate urethra can be properly expanded and the prostate can be inhibited from hyperplasia again through contact drug delivery; the olive-shaped balloon tip design can also prevent damage to the external urethral sphincter. In some embodiments, the two balloon ends are set at a certain angle to the balloon catheter, are made of non-compliant materials, and the balloon is easily retracted into the balloon sheath after the drug delivery is completed, which can further improve the safety of the operation and ensure excellent surgical results. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below. Obviously, the drawings in the following description only relate to some embodiments of the present disclosure, but are not limitations of the present disclosure.

[0022] Figure 1 A schematic diagram showing that both the positioning balloon and the olive-shaped balloon described in Example 1 are not expanded;

[0023] Figure 2 A schematic diagram showing the positioning balloon after expansion in Example 1 is shown;

[0024] Figure 3 A schematic diagram showing the positioning balloon and the olive-shaped balloon described in Example 1 after both are expanded;

[0025] Figure 4 A schematic diagram showing the positioning balloon and the olive-shaped balloon described in Example 2 after both are expanded;

[0026] Figure 5 A schematic diagram showing the positioning balloon and the olive-shaped balloon described in Example 3 after both are expanded;

[0027] The figures are marked as follows: 1 - balloon catheter, 2 - positioning balloon, 3 - olive-shaped balloon, 4 - sheath, 5 - pressurized fluid channel, 6 - guidewire channel, 7 - front part of balloon catheter, 8 - rear part of balloon catheter, 9 - balloon connecting part, 10 - cystoscope. DETAILED DESCRIPTION

[0028] In order to make the purpose, technical solution and advantages of the embodiments of the present disclosure clearer, the technical solution of the embodiments of the present disclosure will be clearly and completely described below in conjunction with the drawings of the embodiments of the present disclosure. Obviously, the described embodiments are part of the embodiments of the present disclosure, not all of the embodiments. Based on the described embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

[0029] The following terms have specific meanings in this application:

[0030] In the present application, the direction along the catheter is defined as “longitudinal”, and the direction perpendicular to the catheter is defined as “radial”. The balloon mainly expands in the radial direction.

[0031] In the present application, the part that first reaches the area to be processed during use is defined as the "front", and the direction opposite to the "front" is defined as the "rear".

[0032] In this application, unless otherwise specified or different meanings can be derived from the context, each term has the meaning commonly understood in the art.

[0033] The present application discloses a prostate drug delivery balloon assembly containing an olive-shaped balloon, which comprises: a balloon catheter, a positioning balloon fixedly arranged at the distal end of the balloon catheter, and an olive-shaped balloon adjacent to the positioning balloon and fixedly arranged on the balloon catheter, wherein a drug composition layer is arranged on the outer surface of the olive-shaped balloon, wherein the positioning balloon is used to be arranged in the patient's bladder for positioning the balloon catheter, and the olive-shaped balloon is used to be arranged in the patient's prostate for dilating and administering the prostate by contacting the inner wall of the prostate, wherein both the positioning balloon and the olive-shaped balloon are non-compliant balloons or low-compliant balloons.

[0034] First, through conventional methods such as guidewire guidance, the balloon catheter is guided along the urethra into the area to be treated. The positioning balloon and the olive-shaped balloon are pressurized to expand. The olive-shaped balloon contacts the outer surface of the prostate. After the drug on the surface of the olive-shaped balloon is administered to the surface of the prostate, the two balloons are depressurized. After the positioning balloon and the olive-shaped balloon are retracted, the balloon catheter is finally withdrawn from the human body to complete the treatment. The positioning balloon and the olive-shaped balloon are both non-compliant balloons or low-compliant balloons. The compliance of the balloon is mainly reflected in the ability of the balloon diameter to change with pressure. The compliance of the balloon is closely related to the material. Commonly used materials include nylon and special polyethylene, which have good physical properties such as ultra-thin thickness, low compliance, and high pressure resistance. The non-compliant and low-compliant balloons ensure the safety of the patient and prevent the excessive expansion of the balloon, which may cause injury to the patient's prostate or bladder.

[0035] In some embodiments, the balloon assembly further comprises a balloon connection portion disposed between the positioning balloon and the olive-shaped balloon, wherein the outer diameter of the balloon connection portion is smaller than the outer diameters of the positioning balloon and the olive-shaped balloon. The balloon connection portion having a smaller diameter can anchor the olive-shaped balloon and the positioning balloon more firmly in the body cavity, thereby preventing the balloon from sliding freely in the body cavity. If the olive-shaped balloon slides or leaves the lesion site, it may cause injury to the healthy lumen.

[0036] In some embodiments, the balloon assembly also includes a sheath tube for accommodating the positioning balloon, the olive-shaped balloon and the corresponding balloon catheter, so that the positioning balloon and the olive-shaped balloon can reciprocate in the sheath tube, and the outer diameter of the sheath tube is 2mm to 10mm, preferably 4mm to 8mm, or 5mm to 7mm. The sheath tube serves to wrap the balloon to prevent the drug from damaging other areas, while ensuring that the two balloons can be expanded in sequence, and allowing the balloon catheter to enter and withdraw conveniently. During treatment, a guide wire is first set, and then the sheath tube is set with the help of a sheath core. After the sheath tube arrives at the desired position, the sheath core is then withdrawn, and the balloon catheter is set through the sheath tube, that is, the balloon is pushed to the desired position. It should be noted that the sheath core used when setting the sheath tube has the meaning commonly understood by those skilled in the art, and is used to be nested in the sheath tube to assist the sheath tube in safely entering the body. When the balloon catheter enters the area to be treated along the urethra, the sheath is pulled toward the rear of the balloon catheter to expose the positioning balloon, and then the pressurizing liquid is injected into the positioning balloon through the pressurizing liquid channel. After the positioning balloon is fully expanded, the positioning balloon is positioned exactly in the patient's bladder. Then the sheath is continued to be pulled toward the rear of the balloon catheter until the olive-shaped balloon is exposed, and the pressurizing liquid is continued to be injected into the pressurizing liquid channel until the olive-shaped balloon is fully expanded. After the drug on the surface of the olive-shaped balloon is administered to the surface of the prostate, the pressurizing liquid is extracted through the pressurizing liquid channel, and negative pressure is generated in the positioning balloon and the olive-shaped balloon. Under the action of the negative pressure, the positioning balloon and the olive-shaped balloon are contracted and folded, and the sheath is moved so that the balloon is completely stored in the sheath to prevent tingling and damage to the human body when the balloon catheter is pulled backward, and finally the sheath and the balloon catheter are withdrawn from the human body at the same time to complete the treatment. The outer diameter of the sheath described in the present application ranges from 2 mm to 10 mm, preferably from 4 mm to 8 mm, or from 5 mm to 7 mm, and the inner diameter is substantially close to the outer diameter, and is usually 0.3 to 0.6 mm smaller than the outer diameter, so that the balloon catheter with the balloon can move in the sheath. The balloon catheter can enter the human body through the sheath during treatment, and after the treatment is completed, the balloon is retracted into the sheath, so that the balloon catheter can be withdrawn smoothly.

[0037] In some embodiments, the balloon connector is non-compliant or low-compliant. The balloon connector may include a material that does not interact with the drug coating or a material such as nylon, polyether block amide (PEBA), polyvinyl chloride (PVC), polyester, polyurethane, derivatives thereof, or a combination thereof, to ensure that the balloon connector is non-compliant or low-compliant, to prevent over-expansion from damaging the bladder, prostate, or the connection between the two. There is no particular limitation on the material and method for making the balloon connector, and those skilled in the art may select according to actual needs.

[0038] In some embodiments, the positioning balloon and the olive-shaped balloon are directly connected, and there is no balloon connection portion between the two balloons. The "no balloon connection portion between the two balloons" mentioned in this application means that the positioning balloon and the olive-shaped balloon are directly connected, and there is no balloon connection portion connection surface. When the two balloons are fully expanded, the outer contour lines of the connection of the two balloons are directly intersected by the balloon expansion arcs.

[0039] In some embodiments, the longitudinal sections of the outer surfaces of the positioning balloon and the olive-shaped balloon each independently have a convex arc-shaped profile at the end. The structure of the end having a convex arc-shaped profile is adapted to the structure of the human body, and avoids damage to the bladder or prostate when the booster fluid channel is pressurized. When pressurized, the balloon can slide slightly appropriately, thereby effectively avoiding damage to the external urethral sphincter when the balloon is expanded.

[0040] In some embodiments, the longitudinal sections of the outer surfaces of the positioning balloon and the olive-shaped balloon are independently at an angle of 30 to 50 degrees with the balloon catheter at the end. The feature that the end of the balloon is at an angle of 30 to 50 degrees with the balloon catheter is adapted to the structure of the human body. The range of 30 to 50 degrees is the most suitable range. If the angle is too large, the shape of the balloon will not match the shape of the prostatic urethra, affecting the effect of drug administration; when the angle is too small, it will make it difficult for the balloon to expand after pressurization to stretch the patient's prostate to obtain enough space, affecting the surgical effect, and it is not easy to have a slight sliding adaptive effect, which is easy to damage the external urethral sphincter. The angle here refers to the angle between the surface of the balloon at the radial dimension of 12 mm and the balloon catheter when the balloon is expanded.

[0041] In some embodiments, the drug composition layer contains at least one of paclitaxel and rapamycin, and an optional drug carrier. The drug carrier preferably includes a hydrophilic drug carrier and / or a hydrophobic drug carrier. In some embodiments, the drug carrier is selected from at least one of iopamidol, iopromide, PEG, and PVP. The existing drug-coated balloon interventional therapy technology attaches drugs that inhibit cell proliferation to the balloon surface, and through the expansion of the balloon, the drug surface is attached to the diseased area to achieve the effect of directly administering drugs to the diseased area to inhibit proliferation. Both paclitaxel and rapamycin have the effect of inhibiting cell proliferation, and are widely used in clinical treatment fields such as anti-cancer. Both of these drugs are lipophilic drugs, and the lipophilic drugs paclitaxel and / or rapamycin are arbitrarily combined with the hydrophilic drugs to form the drug composition, and the hydrophilic drug carrier can form a coating with a high contact surface between the lipophilic drug molecules and the prostate, enhance the dissolution and release of the lipophilic drug molecules, and may change drug delivery and its interaction with tissues. The drug composition is loaded on the surface of the olive-shaped balloon as a balloon coating. After the olive-shaped balloon is expanded, the loaded drug composition is in complete contact with the area to be treated, and the target drug dose is evenly and rapidly released. Clinical experience shows that a short contact time of only 10 minutes is sufficient to fully administer the drug, inhibit cell proliferation, and prevent prostate cell hyperplasia.

[0042] In the present application, the coating position of the pharmaceutical composition is not particularly limited. It should be understood by those skilled in the art that the pharmaceutical composition is mainly coated on the olive-shaped balloon. In some embodiments, the pharmaceutical composition is also coated on the positioning balloon, for example, coated on the side of the positioning balloon facing the olive-shaped balloon. In some embodiments, the pharmaceutical composition can also be coated on the connecting portion of the positioning balloon and the olive-shaped balloon, and the coating drug here is mainly used to treat the internal urethral sphincter.

[0043] In some embodiments, the radial dimensions of the positioning balloon and the olive-shaped balloon when expanded are independently 6-40 mm, such as 10 to 35 mm, such as 12 to 30 mm, such as 15 to 25 mm, such as 16 to 23 mm. The radial dimension of the balloon is directly related to the positioning effect of the positioning balloon and whether it will cause prostate or bladder damage. When the radial dimensions of the positioning balloon and the olive-shaped balloon when expanded are too large, the injection of pressurized liquid causes the balloon to expand. Due to the excessive radial dimensions of the balloon, the bladder and prostate are over-expanded from the inside, which is prone to complications such as urethral hemorrhage. When the radial dimension of the balloon is small, the positioning balloon cannot be accurately positioned, causing the olive-shaped balloon to move back and forth after expansion, and it is impossible to accurately administer medication to the affected area, and it is impossible to fully expand the prostate part that causes urethral stenosis. Affected by individual differences, the selection of a balloon with a suitable radial dimension depends on early medical observations and diagnoses. In addition, the longitudinal dimensions of the positioning balloon and the olive-shaped balloon are independently 20-60 mm, such as 30 to 50 mm, such as 20 to 30 mm, 30 to 40 mm. Similarly, affected by individual differences, the selection of a balloon with a suitable longitudinal dimension depends on early medical observation and diagnosis.

[0044] The above ranges can be used alone or in combination. The present application can be more easily understood through the following examples.

[0045] Example

[0046] Example 1

[0047] like Figure 1-3 As shown, a prostate drug delivery balloon assembly containing an olive-shaped balloon in this embodiment includes: the balloon catheter 1, a positioning balloon 2 fixedly arranged at the distal end of the balloon catheter 1, and an olive-shaped balloon 3 adjacent to the positioning balloon 2 and fixedly arranged on the balloon catheter 1, the positioning balloon and the olive-shaped balloon are directly connected and do not have the balloon connecting part.

[0048] The balloon catheter 1 has a guidewire channel 6 and a pressurized liquid channel 5, wherein the pressurized liquid channel 5 is connected to the positioning balloon 2 and the olive-shaped balloon 3, and the guidewire channel 6 is not connected to the pressurized liquid channel 5.

[0049] The drug delivery balloon assembly further comprises a sheath tube 4 for accommodating the positioning balloon 2, the olive-shaped balloon 3 and the corresponding balloon catheter 1, so that the positioning balloon 2 and the olive-shaped balloon 3 can reciprocate in the sheath tube 4, and a drug composition layer is arranged on the outer surface of the olive-shaped balloon 3.

[0050] Among them, the positioning balloon 2 is used to be set in the patient's bladder for positioning the balloon catheter 1, the olive-shaped balloon 3 is used to be set in the patient's prostate for dilating and administering the prostate by contacting the inner wall of the prostate, the length of the sheath 4 is greater than the length of the balloon catheter 1 in the patient's body when in use, and is less than the length of the balloon catheter 1, and ensures that when the sheath 4 is withdrawn proximally relative to the balloon catheter 1, at least the positioning balloon 2 and the olive-shaped balloon 3 are exposed.

[0051] The length of the balloon catheter 1 is 500mm, and the length in the patient's body during treatment is 250mm. The length of the balloon catheter 1 is greater than the length in the patient's body to ensure the operation space outside the body. The outer diameter of the sheath 4 is 4mm and the length is 300mm. The front part of the sheath of the sheath is 3mm. The outer diameter of the sheath 4 is set to 4mm, which is enough to accommodate the positioning balloon 2, the olive-shaped balloon 3 and the balloon catheter 1, so that it can be stored after the drug administration is completed. The front part of the sheath of the sheath is 3mm and is made of silicone. It is not easy to scratch human organs and tissues, and it is also conducive to storage after the drug administration is completed. The positioning balloon 2 is made of nylon 66 and has non-compliance. Its radial dimension is 30mm when expanded, and it is at an angle of 40 degrees with the balloon catheter 1 at the end. The olive-shaped balloon 3 is made of nylon 66 and is also non-compliant. The radial dimension during expansion is 30mm, and it is at an angle of 30 degrees with the balloon catheter 1 at the end. The non-compliant material is selected, there is no balloon connection part between the two balloons, and they are directly made by blow molding, which greatly improves the safety of the operation. The positioning balloon 2 and the olive-shaped balloon 3 are at an angle of 40 degrees with the balloon catheter 1 at the end, which is easy to slide and avoids damaging the internal urethral sphincter and the external urethral sphincter.

[0052] The method used in this embodiment is as follows:

[0053] First, a guide wire is set, and then a sheath is introduced, and the front section of the guide wire is observed under B-ultrasound to be located in the bladder, and then the prostate drug delivery balloon assembly with an olive-shaped balloon is inserted from the tail of the guide wire until it penetrates into the front section of the guide wire, so that the prostate drug delivery balloon assembly containing the olive-shaped balloon is positioned.

[0054] like Figure 1-2 As shown, the sheath tube 4 is moved toward the rear portion 8 of the balloon catheter until the positioning balloon 2 is completely exposed, at which time the movement of the sheath tube 4 is stopped, and the positioning balloon 2 is pressurized through the pressurizing fluid channel 5. After the positioning balloon 2 is fully expanded, the pressurization is stopped. The balloon catheter 1 is gently pulled, and when a slight resistance is felt, it indicates that the positioning balloon 2 is located at the bladder opening close to the prostate, and the positioning is completed.

[0055] like Figure 3As shown, the sheath tube 4 continues to move along the balloon catheter 1 toward the rear portion 8 of the balloon catheter until the olive-shaped balloon 3 is completely exposed, and the outer surface of the olive-shaped balloon 3 is evenly provided with a drug composition layer composed of paclitaxel and iopromide with a thickness of about 50 microns. The olive-shaped balloon 3 is pressurized through the pressurizing liquid channel 5 until the olive-shaped balloon 3 is fully expanded. The drug composition layer on the surface of the olive-shaped balloon 3 contacts the prostate diseased area, expands the urethral stricture area, and quickly releases the drug to the contacted area. After reaching the predetermined expansion time, the pressurizing liquid is extracted through the pressurizing liquid channel 5, and the sheath tube 4 is moved toward the front portion 7 of the balloon catheter, so that the pressure-free positioning balloon 2 and the olive-shaped balloon 3 are received in the sheath tube 4. Finally, the prostate drug delivery balloon assembly containing the olive-shaped balloon is completely withdrawn to end the treatment.

[0056] The use of a prostate drug delivery balloon treatment containing an olive-shaped balloon in this embodiment can greatly shorten the operation time. The operation can be completed only by contacting the balloon with the prostate, and the treatment process is simple. In addition, the two balloon ends are arranged at an angle of 40 degrees with the balloon catheter 1, are made of non-compliant materials, and the balloon is retracted into the balloon sheath after the drug delivery is completed, which can improve the safety of the operation and ensure excellent surgical results.

[0057] Example 2

[0058] like Figure 4 As shown, the balloon catheter 1, the positioning balloon 2 fixedly arranged at the distal end of the balloon catheter 1, and the olive-shaped balloon 3 adjacent to the positioning balloon 2 and fixedly arranged on the balloon catheter 1, the positioning balloon 2 and the olive-shaped balloon 3 are connected via the balloon connecting portion 9.

[0059] The length of the balloon catheter 1 is 500mm, and the length inside the patient's body during treatment is 250mm. The length of the balloon catheter 1 is greater than the length inside the patient's body, which ensures the operation space outside the body. The positioning balloon 2 is made of nylon 66 and is non-compliant. Its radial dimension is 20mm when expanded, and it forms an angle of 45 degrees with the balloon catheter 1 at the end. The olive-shaped balloon 3 is made of nylon 66 and is also non-compliant. Its radial dimension is 30mm when expanded, and it forms an angle of 45 degrees with the balloon catheter 1 at the end. The balloon connecting part 9 is made of nylon 66, with a length of 3mm. It uses the same material as the positioning balloon 2 and the olive-shaped balloon 3 and is non-compliant.

[0060] The method used in this embodiment is as follows:

[0061] First, a prostate drug delivery balloon assembly containing an olive-shaped balloon is placed in the cystoscope 10, and the cystoscope 10 with the assembly placed is placed in the area to be treated, so that the prostate drug delivery balloon assembly containing the olive-shaped balloon is positioned.

[0062] The pressurizing liquid is directly injected into the positioning balloon 2 and the olive-shaped balloon 3 through the balloon catheter 1 until the positioning balloon 2 and the olive-shaped balloon 3 are fully expanded. The drug composition layer on the surface of the olive-shaped balloon 3 contacts the diseased area of ​​the prostate, expands the urethral stricture area, and quickly releases the drug to the contacted area. After the predetermined expansion time is reached, the pressurizing liquid is extracted through the balloon catheter 1, and the balloon catheter 1 is gently pulled toward the rear part 8 of the balloon catheter, so that the positioning balloon 2 and the olive-shaped balloon 3 are re-entered into the ball cystoscope 10, and finally the prostate drug delivery balloon assembly containing the olive-shaped balloon is completely withdrawn to end the treatment.

[0063] The use of a prostate drug delivery balloon treatment containing an olive-shaped balloon in this embodiment can greatly shorten the operation time. The operation can be completed by only contacting the balloon with the prostate, and the treatment process is simple. The cystoscope 10 is directly used as a channel for the balloon catheter 1, the positioning balloon 2, and the olive-shaped balloon 3, eliminating the sheath component. The two balloon ends are set at an angle of 45 degrees with the balloon catheter 1, are made of non-compliant materials, and the balloon is retracted into the endoscope after the drug delivery is completed. The setting can improve the safety of the operation and ensure excellent surgical results.

[0064] Example 3

[0065] like Figure 5 As shown, the balloon catheter 1, the positioning balloon 2 fixedly arranged at the distal end of the balloon catheter 1, and the olive-shaped balloon 3 adjacent to the positioning balloon 2 and fixedly arranged on the balloon catheter 1, the positioning balloon 2 and the olive-shaped balloon 3 are directly connected, and there is no balloon connecting part between the two balloons.

[0066] Its material size and usage are the same as those in Example 2.

[0067] The “no balloon connection portion between the two balloons” means that the positioning balloon and the olive-shaped balloon are directly connected without a balloon connection portion, and when the two balloons are fully expanded, the outer contour lines of the connection between the two balloons are directly intersecting balloon expansion arcs.

[0068] The above description is merely an exemplary embodiment of the present disclosure and is not intended to limit the protection scope of the present disclosure. The protection scope of the present disclosure is determined by the appended claims.

Claims

1. A balloon assembly for administering drugs to the prostate, comprising: A balloon catheter, a positioning balloon fixedly arranged at the distal end of the balloon catheter, and an olive-shaped balloon adjacent to the positioning balloon and fixedly arranged on the balloon catheter. A drug composition layer is disposed on the outer surface of the olive-shaped balloon, The positioning balloon is used to be placed in the patient's bladder to position the balloon catheter, and the olive-shaped balloon is used to be placed in the patient's prostate to dilate and administer drugs to the prostate by contacting the inner wall of the prostate. Wherein the positioning balloon and the olive-shaped balloon are both non-compliant balloons or low-compliant balloons.

2. The balloon assembly according to claim 1, wherein: It also includes a balloon connecting portion arranged between the positioning balloon and the olive-shaped balloon, and the outer diameter of the balloon connecting portion is smaller than the outer diameters of the positioning balloon and the olive-shaped balloon.

3. The balloon assembly according to claim 1, wherein: It also includes a sheath tube for accommodating the positioning balloon, the olive-shaped balloon and a corresponding balloon catheter, so that the positioning balloon and the olive-shaped balloon can reciprocate in the sheath tube, and the outer diameter of the sheath tube is 2 mm to 10 mm. The balloon assembly according to claim 3 , wherein the outer diameter of the sheath tube is 4 mm to 8 mm.

5. The balloon assembly according to claim 3, wherein the outer diameter of the sheath tube is 5 mm to 7 mm.

6. The balloon assembly according to claim 2, wherein: The balloon connection portion is non-compliant or low-compliant.

7. The balloon assembly according to claim 1, wherein: The positioning balloon and the olive-shaped balloon are directly connected.

8. The balloon assembly according to claim 1, wherein: The longitudinal sections of the outer surfaces of the positioning balloon and the olive-shaped balloon independently have convex arc-shaped contours at the ends.

9. The balloon assembly according to claim 1, wherein: The longitudinal sections of the outer surfaces of the positioning balloon and the olive-shaped balloon independently form an angle of 30 to 50 degrees with the balloon catheter at the end.

10. The balloon assembly according to any one of claims 1 to 7, wherein: The radial dimensions of the positioning balloon and the olive-shaped balloon when expanded are independently 6-40 mm.

11. The balloon assembly according to any one of claims 1 to 7, wherein: The radial dimensions of the positioning balloon and the olive-shaped balloon when expanded are independently 10 to 35 mm.

12. The balloon assembly according to any one of claims 1 to 7, wherein: The radial dimensions of the positioning balloon and the olive-shaped balloon when expanded are independently 12 to 30 mm.

13. The balloon assembly according to any one of claims 1 to 7, wherein: The radial dimensions of the positioning balloon and the olive-shaped balloon when expanded are independently 15 to 25 mm.

14. The balloon assembly according to any one of claims 1 to 7, wherein: The radial dimensions of the positioning balloon and the olive-shaped balloon when expanded are independently 16 to 23 mm.

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