Multifunctional ureter balloon catheter structure

Abstract

The utility model discloses a multifunctional ureter balloon catheter structure, which comprises a catheter main body with an expandable balloon, the front end of the catheter main body is a flexible tip, and a channel for injecting water or air into the expandable balloon is arranged in the catheter main body. And a core wire can extend into the catheter main body from the tail end of the catheter main body and is connected with the flexible tip. The ureteral balloon catheter has the advantages that the expandable balloon wraps the core wire after being shrunk, the outer diameter can be greatly reduced, the flexible tip is soft, damage to ureteral mucosa can be greatly reduced, the guide nozzle with the side opening can guide the ureteral balloon catheter structure to smoothly enter an endoscope, and the ureteral balloon catheter structure is convenient to use. And the guide nozzle can be detached after implantation, so that the operation of a clinician is facilitated.

Description

Technical Field

[0001] The utility model relates to the field of medical devices, in particular to a multifunctional ureteral balloon catheter structure. Background Art

[0002] Ureteral calculi are common diseases in urology. Calculus obstruction can lead to damage to renal function and even cause renal failure in severe cases. Ureteroscopy lithotripsy has many advantages such as minimal invasiveness, repeatable operation, high calculus clearance rate, and controllable complications, and is one of the important means for the treatment of upper urinary tract calculi.

[0003] Due to a physiological stricture at the ureteral orifice of the bladder, in some patients, this stricture is aggravated due to calculus incarceration and other factors, directly leading to difficulties in inserting the ureteroscope, and even resulting in surgical failure. Especially for inexperienced or novice surgeons, false passage formation or ureteral injury is extremely likely to occur during the operation.

[0004] Currently, the ureteroscope generally enters the ureter under the guidance of a guide wire. The front section of the guide wire is relatively thin, with a diameter of 0.032 or 0.038 inch, and it is relatively easy to insert into the ureteral orifice. However, the front end diameter of the ureteroscope is mostly 7F, and there is a large difference in size between the two, resulting in difficulties in inserting the ureteroscope. Further inserting a balloon catheter or other dilation instruments to create a passage for the advancement of the ureteroscope has the following problems: 1) The outer diameter of the balloon catheter or dilation instrument is required to be small enough to pass through the working channel of the ureteroscope; 2) At least one guide wire and a set of dilation instruments are required for a single operation, increasing the operation time and cost.

[0005] The existing balloon catheter products on the market have the following deficiencies: 1) The balloon material is relatively hard, and after inflation and deflation, the balloon cannot fully recover and is in a blade shape. When the catheter is withdrawn, it needs to be pulled out forcefully, which will scratch the ureteral mucosa; 2) The catheter diameter is basically 6F, and the head end is relatively hard; 3) The balloon catheter needs to be guided by a guiding nozzle when entering the endoscope. However, currently, the guiding nozzle cannot be removed after the catheter is inserted, affecting the operation of clinicians.

[0006] Therefore, how to solve the existing product and technical problems, reduce the difficulty of inserting the ureteroscope, improve the surgical success rate, and facilitate the use by clinicians is particularly important. Summary of the Utility Model

[0007] The purpose of the utility model is to provide a multifunctional ureteral balloon catheter structure that can reduce the outer diameter size and damage to the ureteral mucosa and facilitate the operation of clinicians.

[0008] To achieve the above purpose, the utility model adopts the following technical solutions:

[0009] A multifunctional ureteral balloon catheter structure provided by the utility model includes a catheter body with an expandable balloon. The front end of the catheter body is a flexible tip. A channel for injecting water or gas into the expandable balloon is provided in the catheter body. A core wire can extend into the catheter body from the tail end of the catheter body and be connected to the flexible tip.

[0010] Further, the catheter body includes a tube body. The proximal end of the expandable balloon is fixed to one end of the tube body, and the other end of the tube body is connected to a connector. The distal end of the expandable balloon is fixed to the flexible tip. The core wire can pass through the tube body and the inner cavity of the expandable balloon and then be fixed to the flexible tip. The expandable balloon is used for expanding or contracting and covering the corresponding surface of the core wire.

[0011] Further, the expandable balloon is a memory balloon.

[0012] Further, the channel for injecting water or gas into the expandable balloon is the same as the guide wire cavity for the core wire to extend into the tube body, both of which are the inner cavity of the catheter body.

[0013] Further, the material of the expandable balloon is made of semi-compliant material.

[0014] Further, the expandable balloon is columnar, with a filling diameter of 5 - 8 mm and an effective length of 10 - 30 mm.

[0015] Further, the expandable balloon includes a balloon body and multi-lobe arc-shaped fan-shaped balloon leaves. Both ends of the balloon body are respectively communicated with the tube body and the flexible tip. Each balloon leaf can be attached and surrounded outside the balloon body, and each balloon leaf is communicated with the balloon body.

[0016] Further, the number of lobes of the balloon leaf is 5, the lobe separation period is 20 - 30 s, and the curling period is 180 - 200 s.

[0017] Further, the core wire is made of nitinol or stainless steel metal material, and the front section of the core wire has a gradually changing taper.

[0018] Further, the flexible tip is made of PEBAX material with a hardness of 25 - 40 D, or TPU material with a hardness of 80 - 90 A, and the length of the flexible tip is 20 - 25 mm.

[0019] Further, the tube body is provided with scales, and the scales start from the starting point of the scale mark at the proximal end of the expandable balloon.

[0020] Further, the surfaces of the tube body and the flexible tip are provided with a hydrophilic coating.

[0021] Further, an anti-kinking protective sleeve is provided at one end of the tube body close to the connector.

[0022] Furthermore, it also includes a two-way valve, which is connected to the joint.

[0023] Furthermore, it also includes a guide nozzle, which is funnel-shaped and has a through opening on its side.

[0024] Due to the adoption of the above structure, the utility model has the following beneficial effects:

[0025] 1. The utility model provides a catheter body and supports the internal core wire, which plays a role in force conduction during use, thereby facilitating the operator to better operate in the ureteroscope. In addition, since the flexible tip has a certain degree of softness and can be bent arbitrarily, when it touches the ureteral mucosa, bladder wall and other tissues during the advancement process, the flexible tip will actively bend, thereby avoiding damage to the patient.

[0026] 2. The utility model provides an expandable balloon, the two ends of which are respectively fixed to the tube body and the flexible tip and are covered on the corresponding surface of the core wire after shrinkage, thereby effectively reducing the outer diameter and facilitating the passage of the catheter body in the working channel of the ureteroscope.

[0027] 3. The utility model provides a guide nozzle which is funnel-shaped and has a through opening on its side, so as to guide the balloon catheter into the patient and enable the catheter to be detachable after insertion, which is convenient for the clinician to operate.

[0028] The present invention will become more clear through the following description in conjunction with the accompanying drawings, which are used to explain the embodiments of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0030] Figure 1 It is a schematic diagram of the overall structure of the utility model;

[0031] Figure 2 It is a schematic diagram of the utility model in an expanded state;

[0032] Figure 3 It is a partial enlarged schematic diagram of the utility model;

[0033] Figure 4 It is a schematic diagram of the utility model in a contracted state;

[0034] Figure 5It is a schematic diagram of the expandable balloon in the expanded state;

[0035] Figure 6 It is a schematic diagram of the expandable balloon in the contracted state.

[0036] In the figure: 1 - expandable balloon, 2 - tube body, 3 - core wire, 4 - anti-kinking protective sleeve, 5 - connector, 6 - flexible tip, 7 - two-way valve, 8 - guiding nozzle, 101 - proximal end, 102 - distal end, 103 - balloon body, 104 - balloon lobe. Detailed implementation manners

[0037] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.

[0038] As Figure 1-6 shown, the present invention provides a multi-functional ureteral balloon catheter structure, including a catheter main body with an expandable balloon 1. The front end of the catheter main body is a flexible tip 6, which can be bent arbitrarily. During the advancement process, when touching tissues such as the ureteral mucosa and bladder wall, the flexible tip 6 will actively bend, thereby avoiding damage to the patient. A channel for injecting water or gas into the expandable balloon 1 is provided in the catheter main body. A core wire 3 can extend into the catheter main body from the tail end of the catheter main body and be connected to the flexible tip 6. When in use, the expandable balloon 1 is in a contracted state. By controlling the flexible tip 6 and the catheter main body to extend into the ureter or the ureteroscope, and with the support of the internal core wire 3, a force conduction function is achieved during the use process, thus facilitating the operator to better operate in the ureteroscope.

[0039] In the present invention, the catheter main body includes a tube body 2, and the material for making the tube body 2 is nylon material with a certain hardness. Among them, the proximal end 101 of the expandable balloon 1 is fixed to one end of the tube body 2, and the other end of the tube body 2 is connected to the connector 5. The distal end 102 of the expandable balloon 1 is fixed to the flexible tip 6. The core wire 3 can pass through the lumen of the tube body 2 and the expandable balloon 1 and then be fixed to the flexible tip 6. Among them, the expandable balloon 1 is used for expansion work or is contracted and wrapped around the corresponding surface of the core wire 3, so as to effectively reduce the outer diameter size and facilitate the catheter main body to pass through the working channel of the ureteroscope.

[0040] In the present utility model, the expandable balloon 1 is a memory-type balloon. After the expandable balloon 1 shrinks, it is wrapped around the surface of the core wire 3 and baked at 90-110 °C for 1 h, which can endow the expandable balloon 1 with good memory, so that the expandable balloon 1 can still maintain good recoverability after being pressurized and depressurized repeatedly for many times.

[0041] In the present utility model, the channel for injecting water or gas into the expandable balloon 1 is the same as the guide wire cavity for the core wire 3 to extend into the tube body 2, and both are the inner cavity of the catheter main body.

[0042] In the present utility model, the material of the expandable balloon 1 is made of a semi-compliant material.

[0043] In the present utility model, the expandable balloon 1 is columnar, with a filling diameter of 5-8 mm and an effective length of 10-30 mm. For example, the filling diameter of the expandable balloon 1 is 5 mm or 6.5 mm or 8 mm, and the effective length is 10 mm or 20 mm or 30 mm.

[0044] In the present utility model, the expandable balloon 1 includes a balloon body 103 and multi-lobe arc-shaped fan-shaped balloon leaves 104. The two ends of the balloon body 103 are respectively connected to the tube body 2 and the flexible tip 6. Each of the balloon leaves 104 can be attached and surrounded outside the balloon body 103 and each balloon leaf 104 is connected to the balloon body 103. When not in use, the balloon leaves 104 are curled and stacked on the balloon body 103. Injecting water or gas into the expandable balloon 1 can make the balloon body 103 and the balloon leaves 104 expand, and the balloon leaves 104 stretch, so that the outer diameter of the expandable balloon 1 becomes larger, thereby being able to fix the catheter main body.

[0045] In the present utility model, the number of lobes of the balloon leaf 104 is 5, the lobe separation period is 20-30 s, and the curling period is 180-200 s. For example, the lobe separation period is 20 s or 25 s or 30 s, and the curling period is 180 s or 190 s or 200 s.

[0046] In the present utility model, the core wire 3 is made of nitinol alloy or stainless steel metal material, and the front section of the core wire 3 has a gradually changing taper.

[0047] In the present utility model, the flexible tip 6 is made of PEBAX material with a hardness of 25-40 D, or TPU material with a hardness of 80-90 A, and the length of the flexible tip is 20-25 mm. The PEBAX is polyether block amide, and the TPU is thermoplastic polyurethane; PEBAX, Pebax material has excellent film-forming properties and mechanical properties. The balloon wall made of Peabx material is thin, has good dimensional stability, is not easy to rupture, can withstand high pressure, and can generate sufficient expansion force under a small water pressure, and has a good expansion effect on the narrow ureteral duct.

[0048] In the present utility model, the tube body 2 is provided with scales, and the scales are marked starting from the proximal end of the expandable balloon 1. That is, the proximal end of the expandable balloon 1 is the zero position of the scales.

[0049] In the present utility model, the surfaces of the tube body 2 and the flexible tip 6 are provided with hydrophilic coatings, which can enable the tube body 2 and the flexible tip 6 to smoothly pass through the ureteroscope and the stenosis position.

[0050] In the present utility model, an anti-fold protection sleeve 4 is provided at one end of the tube body 2 close to the joint 5.

[0051] In the present utility model, a two-way valve 7 is further included, and the two-way valve 7 is connected to the joint 5. Liquid or gas is filled into the expandable balloon 1 through the two-way valve 7, and the expandable balloon 1 can maintain a constant pressure by adjusting the switch of the two-way valve.

[0052] In the present utility model, a guiding nozzle 8 is further included. The guiding nozzle 8 is funnel-shaped and has a through opening on its side. The structure of the traditional guiding nozzle is optimized, which can guide a multifunctional ureteral balloon catheter structure to smoothly enter the endoscope, and the guiding nozzle 8 can be removed after being inserted, which is convenient for clinicians to operate.

[0053] The operation method of the above-mentioned multifunctional ureteral balloon catheter in clinical application is as follows:

[0054] 1 As Figure 4 shown, the expandable balloon 1 is in a contracted state. The multifunctional ureteral balloon catheter structure is passed through the working channel of the ureteroscope, and the flexible tip 6 is inserted into the ureteral orifice under direct vision. When the expandable balloon 1 gradually moves upward to the stenosis site, 1 ml of water is injected with a syringe. It can be seen under direct vision that the expandable balloon 1 gradually expands. After the ureteral orifice is dilated by the expandable balloon 1, the expandable balloon 1 is deflated to return to the contracted state, and the ureteroscope enters the ureteral lumen through the dilated ureteral orifice;

[0055] 2 The ureteroscope moves upward in the ureteral lumen. After finding a ureteral calculus, the multifunctional ureteral balloon catheter structure is passed through the ureteral calculus. There are scale lines on the tube body 2, and an appropriate length is passed according to the length of the calculus. The expandable balloon 1 is placed above the calculus, and the expandable balloon 1 is injected with water again to expand, forming a seal above the ureteral calculus to prevent the calculus from slipping upward;

[0056] 3 In case of an impacted calculus, first use a holmium laser to crush part of the calculus until there is a gap, and then use the same method to expand and seal after the expandable balloon 1 passes over the calculus; if the calculus escapes, the expandable balloon 1 can be repeatedly contracted and expanded, the position can be adjusted to seal the calculus again, and the remaining calculus can be pulled through the expanded expandable balloon 1 and adjusted to a suitable position for laser lithotripsy.

[0057] Clinical use has shown that: The structure of this multifunctional ureteral balloon catheter can effectively solve the problem of difficult endoscope insertion. The multifunctional ureteral balloon catheter structure is used to bluntly dilate the ureteral orifice, and the degree of dilation of the ureteral orifice is observed throughout the process, which is intuitive and controllable. Compared with the original wire-guided method, it can significantly shorten the endoscope insertion time; the expandable balloon 1 is made of a soft material, which can be repeatedly contracted and expanded, and can adjust the occlusion site according to the position of the stone at any time to prevent the stone from floating upward under the perfusion of water or the impact of energy; obviously, this structure can reduce the operation difficulty of the ureteroscope, reduce the surgical risk, and improve the surgical success rate.

[0058] The preferred embodiments of the present invention have been described above. It should be understood that the present invention is not limited to the above specific embodiments, and the equipment and structures not described in detail should be understood to be implemented in a common manner in the art; any person skilled in the art can make many possible changes and modifications to the technical solution of the present invention by using the methods and technical contents disclosed above without departing from the scope of the technical solution of the present invention, or modify it into an equivalent embodiment with equivalent changes, which does not affect the essence of the present invention. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of the protection of the technical solution of the present invention.

Claims

1. A multifunctional ureteral balloon catheter structure, characterized in that: The invention comprises a catheter body with an expandable balloon (1), the front end of the catheter body is a flexible tip (6), a channel for injecting water or air into the expandable balloon (1) is provided in the catheter body, a core wire (3) can be extended from the rear end of the catheter body into the catheter body and connected to the flexible tip (6); the expandable balloon (1) comprises a balloon body (103) and multi-petal arc-shaped fan-shaped balloon leaves (104), the two ends of the balloon body (103) are respectively connected to the tube body (2) and the flexible tip (6), each of the balloon leaves (104) can fit around the outer side of the balloon body (103) and each of the balloon leaves (104) is connected to the balloon body (103).

2. A multifunctional ureteral balloon catheter structure as claimed in claim 1, characterized in that: The catheter body comprises a tube body (2), wherein the proximal end (101) of the expandable balloon (1) is fixed to one end of the tube body (2) and the other end of the tube body (2) is connected to a joint (5), and the distal end (102) of the expandable balloon (1) is fixed to a flexible tip (6); the core wire (3) can penetrate the tube body (2) and the inner cavity of the expandable balloon (1) and then be fixed to the flexible tip (6); wherein the expandable balloon (1) is used for expansion or expansion work or is covered on the corresponding surface of the core wire (3) after contraction.

3. A multifunctional ureteral balloon catheter structure as claimed in claim 2, characterized in that: The expandable balloon (1) is a memory-type balloon.

4. A multifunctional ureteral balloon catheter structure as claimed in claim 3, characterized in that: The channel for injecting water or air into the expandable balloon (1) is the same as the guidewire cavity for the core wire (3) to extend into the tube body (2), and both are the inner cavities of the catheter body.

5. The multifunctional ureteral balloon catheter structure according to claim 1, characterized in that: The expandable balloon (1) is made of semi-compliant material.

6. The multifunctional ureteral balloon catheter structure according to claim 1, characterized in that: The expandable balloon (1) is columnar, has a filled diameter of 5 to 8 mm, and an effective length of 10 to 30 mm.

7. The multifunctional ureteral balloon catheter structure according to claim 1, characterized in that: The sac leaf (104) has five petals, a petal splitting cycle of 20 to 30 seconds, and a rolling and gripping cycle of 180 to 200 seconds.

8. The multifunctional ureteral balloon catheter structure according to claim 1, characterized in that: The core wire (3) is made of nickel-titanium alloy or stainless steel metal material, and the front section of the core wire (3) has a gradually changing taper.

9. The multifunctional ureteral balloon catheter structure according to claim 1, characterized in that: The flexible tip (6) is made of PEBAX material with a hardness of 25-40D, or TPU material with a hardness of 80-90A, and the length of the flexible tip is 20-25mm.

10. The multifunctional ureteral balloon catheter structure according to claim 2, characterized in that: The tube body (2) is provided with a scale, and the scale marks the starting point of the scale from the proximal end of the expandable balloon (1).

11. The multifunctional ureteral balloon catheter structure according to claim 2, characterized in that: The surfaces of the tube body (2) and the flexible tip (6) are provided with a hydrophilic coating.

12. The multifunctional ureteral balloon catheter structure according to claim 2, characterized in that: An anti-bending protective sleeve (4) is provided at one end of the tube body (2) close to the joint (5).

13. The multifunctional ureteral balloon catheter structure according to claim 2, characterized in that: It also comprises a two-way valve (7), wherein the two-way valve (7) is connected to the connector (5).

14. The multifunctional ureteral balloon catheter structure according to claim 1, characterized in that: It also comprises a guide mouth (8), which is funnel-shaped and has a through opening on its side.

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