A urinary bladder drainage device

Abstract

The application discloses a bladder drainage device which comprises a catheter, a bare sensing electrode, a bare sensing electrode connector, an inner flower crown anti-stone ballon, a heating electrode, a heating electrode connector, a bladder function regulating electrode, a bladder function regulating electrode connector, a left side water injection hole, a water injection catheter interface, a right side drainage hole, a water outlet catheter interface, an outer fixed balloon, an outer fixed balloon water injection hole and an inner flower crown anti-stone balloon water injection hole. The application has the advantages that the drainage device is integrated with the bare sensing electrode, the bladder function regulating electrode contact, the heating electrode and the anti-stone balloon, the diagnosis and treatment function modules are integrated, and the difficult problems that part of neurogenic bladder needs to frequently replace catheters, urine drainage is released and bladder function recovery is promoted can be solved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to a bladder drainage device. Background Technology

[0002] Currently, patients with neurogenic bladder experience varying degrees of loss of efferent nerve innervation. The nerve plexuses and receptors in the submucosal layer of the bladder remain dormant. Physical thermotherapy or intravesical bioelectric stimulation can promote the activation of these receptors. Over time, this process directly generates impulses to the central region of the spinal cord, allowing the patient to perceive these impulses. With more impulse transmission, the detrusor muscle contraction is more effectively promoted, achieving the therapeutic goal. In some patients, due to long-term indwelling cystostomy tubes or catheters, a loose mucus sheath forms between the catheter and the urethral mucosa, providing a favorable environment for bacterial invasion and penetration. Substances in the urine deposit into a thin film, making it easy for bacteria to adhere to the catheter surface. Therefore, these patients experience recurrent bladder-genitourinary tract infections, and smegma formation at the tip of the drainage tube, making removal and replacement difficult. This is more likely to occur in patients with long-term indwelling bladder drainage tubes.

[0003] In clinical practice, the common practice to address this issue is to regularly change the urinary catheter or intensify bladder irrigation to prevent infection and stone formation. However, this approach has significant drawbacks. Frequent catheter changes increase the number of invasive procedures and raise the risk of damage to the bladder and urethral mucosa. Furthermore, evidence-based medicine suggests that with increased bladder irrigation frequency, the incidence of exogenous pathogens entering the body also increases (2019 Guidelines for the Diagnosis and Treatment of Urological Diseases, p. 422).

[0004] Furthermore, some patients experience a reduction in effective bladder capacity, detrusor muscle overactivity unresponsive to medication, high bladder pressure, secondary upper urinary tract dysfunction, and even renal failure requiring hemodialysis. In these cases, simple bladder catheter drainage is insufficient to relieve the obstruction, necessitating invasive sacral nerve electrical stimulation. These clinical problems lead to patient suffering, emotional distress, repeated hospital visits, decreased quality of life, and increased costs. Therefore, a bladder drainage device is needed that can address these issues by providing controllable physical thermotherapy of the bladder mucosa, increasing bladder urine solubility, reducing inflammation, providing bladder mucosal nerve electrical stimulation, and predicting early stone formation. Summary of the Invention

[0005] To overcome the shortcomings of the prior art, the present invention aims to provide a bladder drainage device.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] A bladder drainage device includes a catheter with a central drainage hole in the center. The outer wall of the catheter tip has an inner garland-shaped anti-stone balloon and an outer fixation balloon arranged sequentially from front to back. The inner garland-shaped anti-stone balloon is connected to the catheter via a tubing and has its water inlet located at the end of the catheter. The outer fixation balloon is connected to the catheter via a tubing and has its water inlet located at the end of the catheter.

[0008] The catheter has a left water injection hole and a right drainage hole on the tube wall located between the inner wreath-shaped anti-stone balloon and the outer fixation balloon. The water injection catheter interface connected to the left water injection hole is located at the end of the catheter, and the water outlet catheter interface connected to the right drainage hole is located at the end of the catheter.

[0009] The end face of the catheter tip is provided with an exposed sensing electrode, and the exposed sensing electrode connector, which is connected by a wire, is placed at the end of the catheter.

[0010] The catheter tip has multiple heating electrodes and bladder function control electrode contacts arranged circumferentially on its end face. Each heating electrode is connected to a heating electrode connector via a wire and placed at the end of the catheter. Each bladder function control electrode contact is connected to a bladder function control electrode connector via a wire and placed at the end of the catheter.

[0011] Furthermore, the left-side water injection hole has an inclined structure.

[0012] Furthermore, the inner and outer surfaces of the catheter are respectively provided with a smooth antibacterial coating to prevent adhesion.

[0013] Furthermore, both the heating electrode and the bladder function regulation electrode contacts are narrow square S-shaped.

[0014] Furthermore, both the heating electrode and the bladder function regulation electrode have four contacts, and the heating electrode and the bladder function regulation electrode are arranged alternately.

[0015] Using the above technical solutions, it is possible to predict the formation of smegma at the catheter tip in the early stage, and to provide anti-inflammatory and anti-stone treatments. It can also provide continuous bladder irrigation, thereby prolonging the indwelling time of the bladder drainage tube. At the same time, it has physical thermotherapy with controllable bladder mucosal temperature and electrical stimulation of the bladder mucosa without causing additional damage to the patient, promoting the recovery of bladder urination function, and effectively solving some difficult cases of neurogenic bladder diagnosis and treatment. Attached Figure Description

[0016] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments;

[0017] Figure 1 This is a longitudinal section view of the present invention;

[0018] Figure 2 This is an end view of the catheter tip. Implementation

[0019] like Figure 1-2 As shown, the bladder drainage device of the present invention includes a catheter 1 with a central drainage hole 2 in the center. The catheter 1 is 30cm long and comes in various models from F14 to F120 to meet the needs of different anatomical differences among patients. It is made of silicone, which has high biocompatibility. The inner and outer surfaces of the catheter 1 have a smooth, antibacterial coating designed to prevent adhesion. The central drainage hole 2 is circular in shape with a diameter of approximately 1.5mm and has a dual function of guidewire guidance and drainage. For patients with difficulty in catheterization, the catheter 1 can be placed along the guidewire.

[0020] The outer wall of the catheter tip has an inner garland-shaped anti-stone balloon 3 and an outer fixation balloon 4 arranged sequentially from front to back. The inner garland-shaped anti-stone balloon 3 is connected to the inner garland-shaped anti-stone balloon water inlet 31 through the tubing and placed at the end of the catheter 1. The outer fixation balloon 4 is connected to the outer fixation balloon water inlet 41 through the tubing and placed at the end of the catheter 1. The outer fixation balloon 4 (near the urethral orifice) plays a role in fixation and protection. When the outer fixation balloon 4 (near the bladder) is inflated, it can protect the bladder. At the same time, it can appropriately fill the bladder with water to avoid damage to the heating electrode 8, and can also maximize the prevention of stone formation and ensure the safety of use.

[0021] The catheter 1 has a left water injection hole 5 and a right drainage hole 6 on the wall between the inner flower-shaped anti-stone balloon 3 and the outer fixation balloon 4. The water injection catheter interface 51 connected to the left water injection hole 5 is located at the proximal end of the catheter 1, and the water outlet catheter interface 61 connected to the right drainage hole 6 is located at the distal end of the catheter 1.

[0022] The left-side water inlet 5 can be connected to an external irrigator via the water inlet tube interface 51 to achieve continuous bladder irrigation. The left-side water inlet 5 has a beveled design, and the distal diameter of the left-side water inlet 5 is reduced by 2F compared to the proximal diameter, which helps to enhance the irrigation effect and prevent stone formation. In addition, it can also be used as one of the drainage tube holes.

[0023] The right-side drainage hole 6 is connected to the central drainage hole 2, and a drainage bag is connected to the outside through the water outlet pipe interface 61.

[0024] An exposed sensing electrode 7 is provided on the end face of the catheter 1 tip. The exposed sensing electrode 7 is connected to the exposed sensing electrode connector 71 by a wire and placed at the end of the catheter 1. When the resistance of the exposed sensing electrode 7 changes, it indicates that surface stones and scale have begun to form. Heating to prevent stones should be performed, and more frequent and close monitoring should be conducted. The removal or replacement of the bladder drainage tube should be considered.

[0025] Multiple heating electrodes 8 and bladder function regulating electrodes 9 are arranged circumferentially on the end face of the catheter 1. Each heating electrode 8 is connected to a heating electrode connector 81 via a wire and is placed at the end of the catheter 1. Each bladder function regulating electrode 9 is connected to a bladder function regulating electrode connector 91 via a wire and is placed at the end of the catheter 1. Preferably, in this invention, both the heating electrodes 8 and bladder function regulating electrodes 9 are narrow square S-shaped strips. There are four heating electrodes 8 and four bladder function regulating electrodes 9, which are arranged alternately. Each wire is embedded in the catheter wall.

[0026] Heating electrode 8 has a controlled heating function, which raises the temperature around the bladder end of catheter 1 and conducts heat through the surrounding liquid environment. It uses heat energy to stimulate the bladder mucosa, improve local blood circulation, reduce inflammation, and increase the solubility of solutes in the bladder fluid and has an anti-inflammatory effect. When the inner ring-shaped anti-stone balloon is inflated and fills the bladder to 200-300ml, the inflation and filling states can maximize the protection of the bladder mucosa from damage during heating. If the balloon is repeatedly inflated and deflated, the mechanical force can prevent the shell-like material on the surface of the bladder drainage tube from adhering or falling off, thus playing an anti-stone role.

[0027] The bladder function modulation electrode 9 is connected to an external pulse current generator via the bladder function modulation electrode connector 91. Different pulses have excitatory or inhibitory effects on the nerve endings of the bladder mucosa, thereby playing a neuromodulatory role in urination function. Compared with sacral nerve modulation technology, which is expensive, involves invasive procedures, and requires precise electrode placement, this technology plays a crucial role in urination without adding extra invasive procedures, and offers high adjustability and repeatability. As is well known, the diagnosis and treatment of neurogenic bladder still faces many challenges in clinical practice. Before urination function is restored, intermittent catheterization, indwelling catheterization, or suprapubic cystostomy are currently the most common treatment methods. Therefore, this technology is of great significance in the diagnosis, treatment, and research of neurogenic bladder.

[0028] How to use this invention:

[0029] First, for patients requiring indwelling bladder drainage, insert this catheter 1 using a catheterization method or a bladder stent. If insertion is difficult, first insert a zebra guidewire, pass it through the central drainage hole 2 and insert the catheter 1 along the guidewire, inject 10ml of water through the water injection hole of the external fixation balloon 4, and fix the catheter 1. The external drainage device and water injection device are used. Clinically, after one week, smegma and infection are prone to form at the bladder end of catheter 1. At this time, the resistance change of the exposed sensing electrode 7 is tested daily through the exposed sensing electrode connector 71 to determine whether smegma has formed. After injecting 20ml of water through the inner ring-shaped anti-stone balloon injection port 31, the inner ring-shaped anti-stone balloon 3 is inflated to protect the bladder mucosa around catheter 1 from damage to the bladder mucosa during heating by the heating electrode 8. After heating by the heating electrode 8 for 10 minutes, 20ml of water is released from the inner ring-shaped anti-stone balloon 3 to restore its original state. The bladder function control electrode 9 can then directly contact the bladder mucosa. Through the bladder function control electrode connector, a specific pulse frequency, voltage of 0.5-12V, current of 15-25mA, and frequency of 25Hz are applied for 15 minutes of treatment, 2-3 times a day. The mechanical force of the expansion and contraction of the inner ring-shaped anti-stone balloon 3 after inflation can resist stone formation. When a patient is fully assessed for signs of infection such as frequent urination, urgency, painful urination, cloudy urine, or obstruction of the catheter by secretions, water is first introduced through the water inlet 51. The water then circulates through the right drainage hole 6 or the central drainage hole 2 to the external drainage bag, enabling continuous water flushing.

[0030] The implementation of the present invention has been described above with reference to the accompanying drawings. However, the present invention is not limited to the specific embodiments described above. The specific embodiments described above are illustrative and not intended to limit the present invention. Those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be covered within the scope of the claims and specification of the present invention.

Claims

1. A bladder drainage device, comprising a catheter having a central drainage hole in the center of the catheter, characterized in that: The outer wall of the catheter tip has an inner garland-shaped anti-stone balloon and an outer fixation balloon arranged sequentially from front to back. The inner garland-shaped anti-stone balloon is connected to the catheter via a tubing and has its water inlet located at the end of the catheter. The outer fixation balloon is connected to the catheter via a tubing and has its water inlet located at the end of the catheter. The catheter has a left water injection hole and a right drainage hole on the tube wall located between the inner wreath-shaped anti-stone balloon and the outer fixation balloon. The water injection catheter interface connected to the left water injection hole is located at the end of the catheter, and the water outlet catheter interface connected to the right drainage hole is located at the end of the catheter. The end face of the catheter tip is provided with an exposed sensing electrode, and the exposed sensing electrode connector, which is connected by a wire, is placed at the end of the catheter. The catheter tip has multiple heating electrodes and bladder function control electrode contacts arranged circumferentially on its end face. Each heating electrode is connected to a heating electrode connector via a wire and placed at the end of the catheter. Each bladder function control electrode contact is connected to a bladder function control electrode connector via a wire and placed at the end of the catheter.

2. The bladder drainage device according to claim 1, characterized in that: The left-side water injection hole has an inclined structure.

3. A bladder drainage device according to claim 1, characterized in that: The inner and outer surfaces of the catheter are respectively provided with a smooth antibacterial coating to prevent adhesion.

4. A bladder drainage device according to claim 1, characterized in that: Both the heating electrode and the bladder function regulation electrode contacts are narrow square S-shaped.

5. A bladder drainage device according to claim 1, characterized in that: Both the heating electrode and the bladder function regulation electrode have four contacts, and the heating electrode and the bladder function regulation electrode are arranged alternately.

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