Prostate dilatation balloon catheter system

Abstract

The utility model provides a prostate dilatation balloon catheter system which comprises a balloon which has a contraction state and an expansion state and comprises a first balloon part and a second balloon part, and in the expansion state, the maximum outer diameter of the first balloon part is smaller than the maximum outer diameter of the second balloon part; the near end of the guide tube is provided with an injection port, at least part of the far end enters the interior of the balloon, and the guide tube is provided with a water outlet; at least part of the guide sheath is arranged outside the guide tube in a sleeving mode, and the far-end part of the guide sheath is used for wrapping the balloon in the contraction state; the operation part is connected to the near end of the guide sheath, and when the operation part is driven to move towards the near end, the operation part drives the guide sheath to move towards the near end relative to the guide tube so as to release the balloon. By the adoption of the balloon, after the balloon is conveyed to the prostate position, the neck opening of the bladder is expanded through the first balloon part, the prostate is expanded through the second balloon part, so that benign prostatic hyperplasia is treated, damage to a patient is small, and the treatment effect can be better prolonged.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly to a prostate dilation balloon catheter system. Background Art

[0002] Benign prostatic hyperplasia (BPH) is a slowly developing senile disease, often manifested as symptoms such as frequent urination, urgency of urination, increased nocturia, and incomplete urination. In severe cases, it can cause urinary retention. Existing non-implant treatment methods mainly include transurethral resection of the prostate (TURP), prostate dilation and splitting, etc., but all have the disadvantages of greater patient injury, large intraoperative bleeding volume, and easy recurrence. Among them, the prostate dilation balloon uses the method of dilating the outer membrane of the prostate to open the urethra, but the injury to the patient is relatively high. In order to prolong the treatment effect, drug balloons can also be used for treatment. The drug balloons rely on drugs to maintain the channel after the prostate is dilated, for up to 1 - 1.5 years. However, the drugs have a greater impact on the reproductive system and the price is very high. In addition, some technologies use ureteral dilation balloons for prostate dilation, but the outer diameter is small and the effect can only be maintained for 2 - 4 weeks.

[0003] Therefore, a prostate dilation technology that does not pursue long-term effects but is simple to operate, causes no damage to patients, and has a low price is needed. Summary of the Utility Model

[0004] Aiming at the problems in the prior art, the purpose of the present application is to provide a prostate dilation balloon catheter system. After the balloon is delivered to the prostate position, the bladder neck is dilated by the first balloon part, and the prostate is dilated by the second balloon part to treat benign prostatic hyperplasia, with less damage to the patient and being beneficial to prolonging the treatment effect.

[0005] The embodiment of the present application provides a prostate dilation balloon catheter system, including:

[0006] A balloon, having a contracted state and an expanded state. The balloon includes a first balloon part and a second balloon part. The first balloon part is located at the distal end of the second balloon part, and when the balloon is in the expanded state, the maximum outer diameter of the first balloon part is smaller than the maximum outer diameter of the second balloon part;

[0007] A guiding tube, with an injection port provided at the proximal end of the guiding tube. At least a part of the distal end of the guiding tube enters the interior of the balloon, and a water outlet is provided at the part of the guiding tube located inside the balloon;

[0008] A guiding sheath, at least partially sleeved outside the guiding tube, and the distal part of the guiding sheath is used to cover the balloon in the contracted state;

[0009] The operation part is connected to the proximal end of the guiding sheath. When the operation part is configured to be driven to move in the proximal direction, it drives the guiding sheath to move in the proximal direction relative to the guiding tube, thereby releasing the balloon.

[0010] In some embodiments, it further includes a flexible tip part, and the tip part is arranged at the distal end of the balloon.

[0011] In some embodiments, a smooth transition surface is provided between the first balloon part and the second balloon part.

[0012] In some embodiments, the operation part includes a connecting part and handle parts arranged on both sides of the connecting part, and the extending direction of the handle parts is perpendicular to the extending direction of the guiding sheath.

[0013] In some embodiments, it further includes a finger ring part, and the finger ring part is connected to the proximal end of the guiding tube.

[0014] In some embodiments, a developing part is provided on the outer side of the part of the guiding tube located inside the balloon.

[0015] In some embodiments, the developing part is arranged on the outer side of the part of the guiding tube located inside the first balloon part.

[0016] In some embodiments, the water outlet is arranged at the part of the guiding tube located inside the first balloon part.

[0017] In some embodiments, when the balloon is in the inflated state, the first balloon part includes a first transition section and a first straight section arranged in sequence from the distal end to the proximal end; the second balloon part includes a second transition section, a second straight section and a third transition section arranged in sequence from the distal end to the proximal end. The second transition section is connected to the proximal end of the first straight section, and the outer diameter of the first straight section is smaller than the outer diameter of the second straight section.

[0018] In some embodiments, the outer surface of the guiding sheath is provided with a hydrophilic coating.

[0019] The prostate dilation balloon catheter system provided by the present application has the following advantages:

[0020] The present application provides a prostate dilation balloon catheter system that is non-invasive, takes effect immediately after the operation, and can quickly meet the requirements of patients for lower urinary tract disorders. After the balloon is delivered to the prostate position, the bladder neck is dilated by the first balloon part, and the prostate is dilated by the second balloon part to treat benign prostatic hyperplasia. Since the outer diameter of the second balloon part is smaller, it will not damage the bladder sphincter, and the first balloon part can be set with a larger outer diameter according to needs, which is beneficial to prolonging the treatment effect. There is no need to coat drugs on the surface of the balloon, and there is no drug residue after the operation, avoiding adverse effects of drugs on the reproductive system. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Other features, objects, and advantages of the present application will become more apparent from the following detailed description of non - limiting embodiments read in conjunction with the accompanying drawings.

[0022] Figure 1 FIG. is a schematic structural diagram of a prostate dilation balloon catheter system according to an embodiment of the present application;

[0023] Figure 2 FIG. is a schematic partial structural diagram of a prostate dilation balloon catheter system according to an embodiment of the present application;

[0024] Figure 3 FIG. is a schematic diagram of a prostate dilation balloon catheter system inserted into a surgical site according to an embodiment of the present application;

[0025] Figure 4 FIG. is a schematic diagram of a prostate dilation balloon catheter system after being filled with a contrast agent according to an embodiment of the present application.

[0026] Reference Numerals:

[0027] 1 Tip portion 4 Guide tube

[0028] 2 Balloon 41 Water outlet

[0029] 21 First balloon portion 42 Injection port

[0030] 211 First transition section 5 Operating portion

[0031] 212 First straight section 6 Finger ring portion

[0032] 22 Second balloon portion 7 Imaging portion

[0033] 221 Second transition section 91 Bladder

[0034] 222 Second straight section 92 Bladder neck opening

[0035] 223 Third transition section 93 Prostate

[0036] 3 Guide sheath DETAILED DESCRIPTION OF THE EMBODIMENTS

[0037] Example embodiments will now be described more fully. However, the example embodiments can be implemented in various forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this application will be thorough and complete, and will fully convey the concept of the example embodiments to those skilled in the art. Like reference numerals in the figures denote like or similar structures, and thus their repetitive description will be omitted. In the specification, "or" or "either...or" may mean "and" or "or". Nothing in this specification should be construed as requiring a particular three-dimensional orientation of the structure to fall within the scope of this application. Although the terms "first", "second", etc. are used in this specification to denote certain features, they are merely for the purpose of indication and do not limit the quantity and importance of the specific features.

[0038] To solve the technical problems in the prior art, an embodiment of the present application provides a prostate dilation balloon catheter system, which includes a balloon, a guiding tube, a guiding sheath, and an operating portion. Among them, the balloon has a contracted state and an inflated state. The proximal end of the guiding tube is provided with an injection port, and at least a part of the distal end of the guiding tube enters the interior of the balloon, and a water outlet is provided at the part of the guiding tube located inside the balloon. The guiding sheath is at least partially sleeved outside the guiding tube, and the distal part of the guiding sheath is used to cover the balloon in the contracted state. The operating portion is connected to the proximal end of the guiding sheath. When the operating portion is configured to be driven to move in the proximal direction, it drives the guiding sheath to move in the proximal direction relative to the guiding tube, thereby releasing the balloon. After the balloon is released, a contrast agent can be injected into the balloon through the guiding tube to inflate the balloon.

[0039] In the present application, the balloon includes a first balloon portion and a second balloon portion. The first balloon portion is located at the distal end of the second balloon portion. When the balloon is in the inflated state, the maximum outer diameter of the first balloon portion is smaller than the maximum outer diameter of the second balloon portion. Therefore, after the balloon is delivered to the prostate position and enters the inflated state, the bladder neck opening is dilated by the first balloon portion, and the prostate is dilated by the second balloon portion to treat benign prostatic hyperplasia. Since the outer diameter of the second balloon portion is smaller, it will not damage the bladder sphincter, and the first balloon portion can be set to have a larger outer diameter as needed, which is beneficial to prolong the treatment effect. There is no need to coat the surface of the balloon with drugs, and there is no drug residue after the operation, avoiding adverse effects of drugs on the reproductive system. Therefore, the present application provides a prostate dilation balloon catheter system that is non-invasive, has an immediate effect after the operation, and can quickly meet the requirements of patients for lower urinary tract obstruction.

[0040] The structure of the prostate dilation balloon catheter system in the embodiments will be specifically introduced below in conjunction with the accompanying drawings. The same reference numerals in the drawings denote the same or similar structures, and thus their repeated descriptions will be omitted. In the present application, the distal end and the proximal end are relative to the operator. The end close to the operator is the proximal end, and the end far from the operator is the distal end. The proximal end is also the end far from the surgical site, and the distal end is also the end close to the surgical site.

[0041] As Figure 1 and Figure 2 shown, an embodiment of the present application provides a prostate dilation balloon catheter system, including a balloon 2, a guiding tube 4, a guiding sheath 3, and an operating portion 5. Among them, the balloon 2 has a contracted state and an inflated state. Figure 1 What is shown is the structure of the balloon 2 in the inflated state. The balloon catheter system further includes a flexible tip portion 1, and the tip portion 1 is provided at the distal end of the balloon 2. The head shape of the tip portion 1 can be selected as a conical shape. By providing the tip portion 1, it is easier to bend through the stenosis section when inserting the balloon 2 into the urethra, and it is not easy to damage the urethra. A liquid injection port 42 is provided at the proximal end of the guiding tube 4, and a Luer connector is provided at the liquid injection port 42 for injecting contrast liquid into the balloon 2 and performing a vacuum pumping operation when withdrawing the balloon 2. At least a part of the distal end of the guiding tube 4 enters the interior of the balloon 2, and a water outlet 41 is provided at the part of the guiding tube 4 located inside the balloon 2. The contrast liquid can be injected into the interior of the balloon 2 through the guiding tube 4 to enable the balloon 2 to enter the inflated state from the contracted state. In this embodiment, a finger ring portion 6 is further provided at the proximal end of the guiding tube 4 to facilitate the doctor's grasping during the operation. The finger ring portion 6, the Luer connector, and the guiding tube 4 can be made of a polymer material. A developing portion 7 is provided on the outer side of the part of the guiding tube 4 located inside the balloon 2. The position of the balloon 2 in the body can be observed through the developing portion 7. The developing portion 7 is, for example, a developing ring provided on the outer side of the guiding tube 4, and it is made of a developing material such as platinum tungsten, platinum iridium, and the like.

[0042] As Figure 1As shown, the guiding sheath 3 is at least partially sleeved outside the guiding tube 4, and the distal part of the guiding sheath 3 is used to wrap the balloon 2 in a contracted state. In the initial state, the balloon 2 is not filled with the developer solution and is in a contracted state and is received inside the distal end of the guiding sheath 3. The operating part 5 is connected to the proximal end of the guiding sheath 3. When the operating part 5 is configured to be driven to move in the proximal direction, it drives the guiding sheath 3 to move in the proximal direction relative to the guiding tube 4, and releases the balloon 2. After the balloon 2 is released, injecting the developer solution into the balloon 2 through the guiding tube 4 can make the balloon 2 enter the inflated state. The guiding sheath 3 can be made of a composite polymer material, which can increase the rigidity and toughness of the overall balloon catheter system. In this embodiment, the operating part 5 includes a connecting part and handle parts provided on both sides of the connecting part. The extending direction of the handle parts is perpendicular to the extending direction of the guiding sheath 3, so that the overall operating part 5 has a handle structure, and the structure of the operating part 5 is more convenient for doctors to hold and operate.

[0043] As Figure 2 shown, the balloon 2 includes a first balloon part 21 and a second balloon part 22. The balloon 2 can be made of a polymer material and has semi-compliance. When the developer solution is injected in the contracted state, it can expand outward to dilate the prostate and the bladder neck. The first balloon part 21 is located at the distal end of the second balloon part 22. The first balloon part 21 is used to dilate the bladder neck, and the second balloon part 22 is used to dilate the prostate. When the balloon 2 is in the inflated state, the maximum outer diameter of the first balloon part 21 is smaller than the maximum outer diameter of the second balloon part 22. A smooth transition surface is provided between the first balloon part 21 and the second balloon part 22 to enable a smooth transition between the first balloon part 21 and the second balloon part 22. Specifically, when the balloon 2 is in the inflated state, the first balloon part 21 includes a first transition section 211 and a first straight section 212 arranged in sequence from the distal end to the proximal end. The surface of the first transition section 211 is an inclined transition surface. The second balloon part 22 includes a second transition section 221, a second straight section 222, and a third transition section 223 arranged in sequence from the distal end to the proximal end. The second transition section 221 is connected to the proximal end of the first straight section 212. The surface of the second transition section 221 serves as the transition surface between the first balloon part 21 and the second balloon part 22, and the surface of the third transition section 223 is also an inclined transition surface. The first straight section 212 is the main part for dilating the bladder neck, and it is a column with a substantially uniform outer diameter. The second straight section 222 is the main part for dilating the prostate, and it is a column with a substantially uniform outer diameter. The outer diameter of the first straight section 212 is smaller than the outer diameter of the second straight section 222 to meet the different requirements of its dilated parts.

[0044] Next, in combination with Figure 3And Figure 4 Specifically introduce the usage method of the prostate dilation balloon catheter system. The process of performing surgery using this balloon catheter system is mainly divided into the following steps:

[0045] (1) The patient is in the lithotomy position and undergoes spinal anesthesia. Then, the doctor uses a cystoscope to observe the conditions of the patient's urethra, prostate 93, bladder neck 92, etc.

[0046] (2) Take out the balloon catheter system in the initial state. In the initial state, the balloon 2 is in a contracted state and is received inside the distal end of the guiding sheath 3, and the operating part 5 is in a low position near the surgical site as shown. The doctor retrogradely inserts the tip part 1 of the balloon catheter system from the urethral orifice, and the tip part 1 reaches inside the bladder 91. Since the imaging part 7 is provided inside the balloon 2, the front half of the balloon 2 can be confirmed to be located at the bladder neck 92 position by using an X-ray machine. At this time, the cooperation between the balloon catheter system and the surgical site is as shown. Figure 3 In this embodiment, the imaging part 7 can be optionally provided on the outer side of the part of the guiding tube 4 located inside the first balloon part 21, so as to more accurately determine the position where the first balloon part 21 is located and ensure that the first balloon part 21 is located at the bladder neck 92 position. Figure 3 as shown.

[0047] In this embodiment, the outer surface of the guiding sheath 3 is provided with a hydrophilic coating. When the guiding sheath 3 is partially inserted into the body, the guiding sheath 3 will not damage the urethra.

[0048] In this embodiment, the outer surface of the guiding sheath 3 is provided with a hydrophilic coating. When the guiding sheath 3 is partially inserted into the body, the guiding sheath 3 will not damage the urethra.

[0049] (3) The doctor holds the ring part 6 with one hand and presses the operating part 5 in the proximal direction with the other hand, so that the operating part 5 moves proximally to the high position as shown, until the operating part 5 reaches the position of the ring part 6. The operating part 5 drives the guiding sheath 3 to retract proximally to release the balloon 2. The balloon 2 completely disengages from the guiding sheath 3, with its first balloon part 21 located at the bladder neck 92 and the second balloon part 22 located at the prostate 93 position. Figure 4 as shown.

[0050] (4) The doctor uses a pressure pump to inject the imaging liquid into the injection port 42. The imaging liquid enters the balloon 2 through the water outlet 41, causing the balloon 2 to expand outward until the pressure reaches 3 - 5 atmospheres, and then stops injecting the imaging liquid. At this time, the cooperation between the balloon catheter system and the surgical site is as shown. Figure 4As shown, maintain in this state for 5 to 10 minutes. Therefore, after the balloon 2 is delivered to the prostate 93 position and the balloon 2 enters the inflated state, the bladder neck 92 is dilated by the first balloon portion 21, and the prostate 93 is dilated by the second balloon portion 22 to treat benign prostatic 93 hyperplasia. Since the outer diameter of the second balloon portion 22 is small, it will not damage the bladder sphincter, and the first balloon portion 21 can be set with a larger outer diameter as needed, which is beneficial to prolong the treatment effect.

[0051] In this embodiment, the water outlet 41 can be optionally provided at the part of the guiding tube 4 located within the first balloon portion 21. When injecting the contrast agent, the first balloon portion 21 is first filled, but the present application is not limited thereto.

[0052] (5) Finally, the contrast agent inside the balloon 2 is drawn out through the injection port 42, so that the balloon 2 shrinks again, and the balloon catheter is withdrawn along the original path. The shrunk balloon 2 can be easily withdrawn from the urethra. At this time, a cystoscope 91 is used to check the conditions of the patient's urethra, prostate 93, and bladder neck 92 after dilation.

[0053] Therefore, the present application provides a prostate dilation balloon catheter system that is non-invasive, immediately effective after surgery, and can quickly meet the requirements of patients for lower urinary tract obstruction. A good treatment effect can be achieved without coating drugs on the surface of the balloon 2, and there is no drug residue after surgery, avoiding adverse effects of drugs on the reproductive system. When performing surgery using this prostate dilation balloon catheter system, it can also be operated under transrectal ultrasound, avoiding X-ray radiation. Moreover, in this embodiment, by providing the ring portion 6 and the handle-shaped operation portion 5, it is more convenient for doctors to hold and operate, and it is more convenient to use. An inclined transition surface is provided between the first balloon portion 21 and the second balloon portion 22, at the distal end of the first balloon portion 21, and at the proximal end of the second balloon portion 22 to achieve a smooth transition and prevent damage to the urethra during use.

[0054] The above content is a further detailed description of the present application in combination with specific preferred embodiments. It cannot be determined that the specific implementation of the present application is only limited to these descriptions. For those of ordinary skill in the technical field to which the present application belongs, without departing from the concept of the present application, several simple deductions or substitutions can still be made, which should all be regarded as belonging to the protection scope of the present application.

Claims

1. A prostate dilatation balloon catheter system, characterized in that: include: A balloon having a contracted state and an expanded state, the balloon comprising a first balloon portion and a second balloon portion, the first balloon portion being located at the distal end of the second balloon portion, and when the balloon is in the expanded state, the maximum outer diameter of the first balloon portion is smaller than the maximum outer diameter of the second balloon portion; A guide tube, wherein the proximal end of the guide tube is provided with an injection port, the distal end of the guide tube at least partially enters the interior of the balloon, and the portion of the guide tube located in the balloon is provided with a water outlet; A guide sheath, wherein the guide sheath is at least partially sleeved on the outside of the guide tube, and the distal end of the guide sheath is used to cover the balloon in a contracted state; The operating part is connected to the proximal end of the guide sheath. When the operating part is driven to move in the proximal direction, it drives the guide sheath to move in the proximal direction relative to the guide tube, thereby releasing the balloon.

2. The prostate dilatation balloon catheter system according to claim 1, characterized in that: Also included is a flexible tip portion disposed at the distal end of the balloon.

3. The prostate dilatation balloon catheter system according to claim 1, characterized in that: A smooth transition surface is provided between the first balloon portion and the second balloon portion.

4. The prostate dilatation balloon catheter system according to claim 1, characterized in that: The operating portion includes a connecting portion and handle portions arranged on both sides of the connecting portion, and an extending direction of the handle portions is perpendicular to an extending direction of the guide sheath.

5. The prostate dilatation balloon catheter system according to claim 1, characterized in that: It also includes a finger ring portion, which is connected to the proximal end of the guide tube.

6. The prostate dilatation balloon catheter system according to claim 1, characterized in that: A developing portion is provided on the outer side of the portion of the guide tube located in the balloon.

7. The prostate dilatation balloon catheter system according to claim 6, characterized in that: The developing portion is disposed outside a portion of the guide tube located inside the first balloon portion.

8. The prostate dilatation balloon catheter system according to claim 1, characterized in that: The water outlet is arranged at the portion of the guide tube located inside the first balloon portion.

9. The prostate dilatation balloon catheter system according to claim 1, characterized in that: When the balloon is in the expanded state, the first balloon portion includes a first transition section and a first straight section arranged in sequence from the distal end to the proximal end; the second balloon portion includes a second transition section, a second straight section and a third transition section arranged in sequence from the distal end to the proximal end, the second transition section is connected to the proximal end of the first straight section, and the outer diameter of the first straight section is smaller than the outer diameter of the second straight section.

10. The prostate dilatation balloon catheter system according to claim 1, characterized in that: The outer surface of the guide sheath is provided with a hydrophilic coating.

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