Catheter with variable pipe diameter

Abstract

The utility model relates to a catheter with a variable pipe diameter, and belongs to the technical field of medical instruments. Comprising a catheter body internally provided with a urinary catheterization channel. The first sleeve is coaxially connected to the outer part of the catheter main body in a sleeving manner; the elastic anchoring sleeve is coaxially connected to the exterior of the first sleeve in a sleeving mode, and a second annular channel is defined by the elastic anchoring sleeve and the outer wall of the first sleeve; and the pressure release structure is communicated with the second annular channel and is configured to be in an open state or a closed state based on the fluid pressure in the second annular channel. The elastic anchoring sleeve can reliably prevent excessive radial pressure applied to urethral mucosa due to excessive expansion of the elastic anchoring sleeve, so that serious complications such as ischemia, edema, pressure necrosis and even long-term urethrostenosis caused by long-term compression of local tissues are effectively avoided.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, and particularly relates to a catheter with variable tube diameter. Background Technique

[0002] Indwelling catheters are widely used medical devices in clinical practice. They mainly drain urine through a hollow tube body and rely on an inflatable positioning balloon arranged at the distal end of the tube body to be anchored in the bladder to prevent the catheter from falling off. However, this traditional design that only relies on the end balloon for single-point fixation has an inherent defect of insufficient stability in clinical practice. The catheter still has a large movement space in the body and is prone to axial reciprocating movement or rotation due to changes in the patient's body position or accidental pulling. This will not only stimulate the urethra and bladder neck, causing pain and discomfort to the patient, but also may lead to unsmooth drainage, and even cause trauma under accidental pulling.

[0003] To solve the above technical pain points of unstable fixation, those skilled in the art will additionally add an inflatable tube section on the tube body of the catheter, and after the catheter is inserted, it is filled to make it radially expand and fully fit with the inner wall of the patient's urethra, so as to achieve axial fixation of the catheter tube body.

[0004] However, the urethra is a tubular organ that is more narrow, delicate and sensitive than the bladder, and its mucosal tissue is very sensitive to continuous pressure. When filling this variable-diameter tube section, if it completely relies on manual operation, it is extremely easy to cause its over-expansion due to excessive injection of fluid. The over-expanded tube section will exert too large and continuous radial pressure on the inner wall of the urethra, which will seriously hinder the blood circulation of the capillaries under the urethral mucosa and may cause ischemia and edema of local tissues in a short time. If the duration is longer, it will even cause irreversible pressure necrosis and urethral stricture. Urethral stricture is a serious long-term complication that will bring long-term dysuria to the patient and often requires multiple dilations or even surgical operations to solve, bringing great physical and mental pain to the patient. Content of the Utility Model

[0005] To solve the above-mentioned problems of the prior art, the utility model provides a catheter with variable tube diameter.

[0006] To achieve the above purpose, the technical solution adopted by the utility model is:

[0007] Provide a catheter with variable tube diameter, including:

[0008] A catheter body, which has a urine drainage channel inside;

[0009] A first cannula coaxially sleeved outside the catheter body and defining a first annular channel with the outer wall of the catheter body, the first annular channel communicating with a positioning balloon provided at the end of the catheter body;

[0010] An elastic anchoring cannula coaxially sleeved outside the first cannula and defining a second annular channel with the outer wall of the first cannula;

[0011] And a pressure release structure communicating with the second annular channel and configured to be in an open state or a closed state based on the fluid pressure in the second annular channel.

[0012] Preferably, the pressure release structure is a valve assembly, and the valve assembly includes:

[0013] A valve seat fixed to the elastic anchoring cannula and forming a fluid communication with the second annular channel;

[0014] And an elastic pressure release member installed in the valve seat;

[0015] Wherein, an outlet end of the pressure release member forms a pair of valve lips that are attached to each other by their own elasticity in a natural state;

[0016] And only when the fluid pressure in the second annular channel overcomes the elasticity of the valve lips, the pair of valve lips opens to release pressure.

[0017] Preferably, an annular manifold cavity is defined inside the valve seat, the annular manifold cavity is used to collect the fluid released by the pressure release member, and the outlet end of the pressure release member is located in the annular manifold cavity.

[0018] Preferably, at least a part of the annular manifold cavity is defined by an elastic wall surface, and the elastic wall surface is configured to undergo a recoverable expansion deformation due to accommodating the fluid when the pressure release member releases the fluid.

[0019] Preferably, the elastic wall surface includes a thin-walled region with a thickness smaller than its peripheral region, and the thin-walled region is configured to form an externally convex portion that can be visually recognized or tactilely sensed due to preferentially undergoing elastic expansion.

[0020] Preferably, the tube wall of the elastic anchoring cannula is configured to have an uneven wall thickness, so that after being filled, the radial expansion profile along its axis is in an olive shape or a barrel shape with a middle diameter larger than the diameters at both ends.

[0021] Preferably, two filling ports respectively communicating with the first annular channel and the second annular channel are provided at the proximal end of the catheter body;

[0022] Moreover, the two filling ports are different in at least one of the following features:

[0023] Different color markings;

[0024] Or, mutually exclusive mechanical interface configurations.

[0025] Preferably, the urinary catheterization channel forms at least one urinary catheterization hole at the distal end of the catheter body.

[0026] Preferably, a preset neck length is axially spaced between the proximal end of the positioning balloon and the distal end of the elastic anchoring sleeve along the catheter body. The neck length is configured such that when the positioning balloon is correctly positioned in the patient's bladder, the elastic anchoring sleeve is located in the urethra.

[0027] Preferably, an emergency pressure relief structure communicating with the first annular channel is provided at the proximal end of the catheter body;

[0028] Wherein, the emergency pressure relief structure is configured to be permanently opened through an irreversible mechanical operation.

[0029] The present utility model provides a variable-diameter urinary catheter. The beneficial effects of the present utility model are as follows:

[0030] Through the elastic pressure release structure of the present utility model, pressure relief is initiated when the fluid pressure exceeds the preset range, which can reliably prevent excessive radial pressure exerted on the urethral mucosa due to over-expansion of the elastic anchoring sleeve, thereby effectively avoiding serious complications such as ischemia, edema, pressure necrosis caused by long-term local tissue compression, and even long-term urethral stricture. Description of the Drawings

[0031] Figure 1 is the front view of the variable-diameter urinary catheter proposed by the present utility model;

[0032] Figure 2 is the cross-sectional view of the variable-diameter urinary catheter proposed by the present utility model;

[0033] Figure 3 is Figure 2 the partial enlarged schematic view at A;

[0034] Figure 4 is the structural schematic view when the valve lip of the variable-diameter urinary catheter proposed by the present utility model is opened;

[0035] Figure 5 is the structural schematic view of the elastic wall surface and the thin-wall region of the variable-diameter urinary catheter proposed by the present utility model.

[0036] Description of the Reference Numerals:

[0037] 1. Catheter body; 101. Urinary catheterization channel; 2. First sleeve; 201. First annular passage; 3. Positioning balloon; 4. Elastic anchoring sleeve; 401. Second annular channel; 5. Pressure release structure; 501. Valve seat; 5011. Annular manifold chamber; 5012. Elastic wall surface; 5013. Thin wall region; 502. Pressure release member; 5021. Valve lip; 6. Filling port; 7. Emergency pressure relief structure. Detailed implementation manners

[0038] 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.

[0039] Please refer to Figures 1 - 5 As shown below, the specific embodiments provided by the present invention are as follows:

[0040] As Figures 1 to 2 As shown, an embodiment of the present invention provides a variable-diameter urinary catheter having a catheter body 1. The catheter body 1 has a distal end inserted into the patient's bladder and a proximal end for connecting devices such as a urinary catheter belt. Among them, a urinary catheterization channel 101 is formed inside the catheter body 1, and the urinary catheterization channel 101 is used for discharging urine from the patient's body.

[0041] In a specific implementation manner, at least one urinary catheterization hole is formed at the distal end of the urinary catheterization channel 101 in the catheter body 1.

[0042] The variable-diameter urinary catheter further includes a first sleeve 2. The first sleeve 2 is coaxially sleeved outside the catheter body 1, and a first annular passage 201 is formed between the two. Among them, the distal end of the first annular passage 201 is communicated with a positioning balloon 3. During clinical use, medical staff can inject a fluid (such as sterile water or air) into the first annular passage 201 through the corresponding port at the proximal end of the first sleeve 2 to fill the positioning balloon 3, so as to achieve preliminary anchoring in the patient's bladder.

[0043] Among them, the variable-diameter urinary catheter further includes an elastic anchoring sleeve 4. The elastic anchoring sleeve 4 is the outermost tubular structure of the entire catheter device, and it is coaxially sleeved outside the first sleeve 2. Therefore, a second annular channel 401 is defined between the inner wall of the elastic anchoring sleeve 4 and the outer wall of the first sleeve 2. During clinical use, the outer wall of the elastic anchoring sleeve 4 is the surface in direct contact with the patient's urethral tissue.

[0044] The elastic anchoring sleeve 4 is made of a medical-grade elastomer with high elasticity or high compliance, such as medical-grade silicone rubber or thermoplastic elastomer. This material selection ensures that when the sleeve is subjected to internal fluid pressure, it can undergo significant and controllable radial expansion deformation, and after the pressure is removed, it can basically return to its original, smaller outer diameter state relying on its own elastic restoring force.

[0045] When the catheter is inserted into the patient's body and the terminal positioning balloon 3 completes the initial fixation in the bladder, medical staff can inject fluid into the second annular channel 401 through the corresponding filling port 6. The injected fluid will fill the second annular channel 401 and exert a uniform pressure on the inner wall of the elastic anchoring sleeve 4, causing it to expand radially outward. The outer wall of the expanded sleeve will gently and comprehensively fit with the inner wall of the patient's urethra, thereby generating an axial frictional fixing force along a section of the length of the catheter body 1. Thus, the stability of the catheter body 1 in the body is improved, and it can effectively prevent the reciprocating movement, rotation, and accidental dislodgment of the catheter body 1 in the urethra caused by changes in the patient's body position, body movement, or accidental bedding pulling.

[0046] As Figures 3 to 4 shown, on the above basis, it further includes an elastic pressure release structure 5. The elastic pressure release structure 5 is connected to the second annular channel 401 that fills the elastic anchoring sleeve 4.

[0047] In a specific implementation, the elastic pressure release structure 5 is specifically a valve assembly. The valve assembly includes a valve seat 501 and a pressure release member 502 installed therein. The pressure release member 502 is preferably made of medical-grade silicone or other high-elastic polymers through an integral molding process.

[0048] Specifically, the outlet end of the pressure release member 502 is configured to have a pair of elastic valve lips 5021 that are tightly fitted by the elasticity of the material itself in the natural state. This pair of valve lips 5021 together form a normally closed slit. Therefore, only when the fluid pressure in the second annular channel 401 rises and the generated thrust is sufficient to overcome the inherent elastic restoring force of this pair of valve lips 5021, the slit will be opened passively to form a pressure relief passage to discharge the excess fluid. Once the pressure drops and the fluid thrust weakens, the valve lips 5021 will instantly rebound by their elasticity and close the slit again, thereby maintaining the pressure in the second annular channel 401 below a preset upper limit that is safe for human tissues.

[0049] Further, an annular flow collecting cavity 5011 for collecting the released fluid is provided inside the valve seat 501. When the fluid pressure in the second annular channel 401 reaches or exceeds a preset threshold value, that is, the valve lip 5021 is opened, the fluid enters the annular flow collecting cavity 5011 to prevent the elastic anchoring sleeve 4 from overexpanding and damaging the urethra.

[0050] As Figure 5 shown, in a specific embodiment, at least a part of the annular flow collecting cavity 5011 is defined by an elastic wall surface 5012, and the elastic wall surface 5012 is configured to undergo a recoverable expansion deformation due to accommodating the fluid when the pressure release member 502 releases the fluid.

[0051] Specifically, when the pressure in the second annular channel 401 triggers the opening of the pressure release member 502, the fluid will rush into the annular flow collecting cavity 5011. If the annular flow collecting cavity 5011 is a cavity with a fixed volume, then the fluid it can accommodate will be limited.

[0052] What is expected in this embodiment is that through the expansion deformation of the elastic wall surface 5012, the annular flow collecting cavity 5011 has a larger volume, so as to accommodate more fluid, relieve the fluid pressure in the second annular channel 401, and further prevent the elastic anchoring sleeve 4 from overexpanding, effectively protecting the urethra.

[0053] On the above basis, the elastic wall surface 5012 includes a thin-wall region 5013 with a thickness smaller than its peripheral region, and the thin-wall region 5013 is configured to form an externally protruding part that can be visually recognized or tactilely sensed due to preferentially undergoing elastic expansion.

[0054] Based on this, by introducing an uneven wall thickness, the stress is actively guided and concentrated, so that the expansion deformation is no longer uniform, but has a clear functional orientation.

[0055] Therefore, when pressure relief occurs and the fluid rushes into the annular flow collecting cavity 5011, the entire elastic wall surface 5012 will be pressurized and start to expand. At the same time, since the structural resistance of the thin-wall region 5013 is much lower than that of the thick-wall region around it, most of the expansion deformation will occur concentratedly here. As a result, the thin-wall region 5013 will quickly and preferentially bulge outwards, forming a clear indication bubble or tactile button outside the valve seat 501. Thus, it serves as an extremely intuitive event indicator. The appearance of this bulge provides a signal that can be visually recognized or tactilely sensed for medical staff, clearly informing them that the pressure relief event has occurred, and they should pay attention to the patient's condition or check the operation process.

[0056] In this embodiment, the wall of the elastic anchoring sleeve 4 is configured to have an uneven wall thickness, so that after it is filled, the radial expansion profile along its axis is in the shape of an olive or a barrel with a middle diameter larger than the diameters at both ends.

[0057] Specifically, when the second annular channel 401 is uniformly injected with fluid, the pressure will cause the entire sleeve to expand. However, since the wall of the middle section is thinner and its structural resistance is relatively small, the maximum elastic deformation will occur; while the thicker walls at both ends will limit their own expansion degree. This preset wall thickness gradient ultimately guides the entire sleeve to form an olive or barrel-shaped profile that is plump in the middle and narrowed at both ends after being filled.

[0058] The olive or barrel-shaped structure can form an effective mechanical self-locking in the urethra. Its widest middle part provides a strong radial supporting force, closely fits with the urethral wall, and effectively prevents the axial sliding of the catheter.

[0059] On the other hand, the human urethra is not a pipe with a completely uniform diameter. The olive or barrel shape can better adapt to the natural shape of the urethra, concentrate the main supporting force on the relatively wide section of the urethra, and at the same time reduce the compression on sensitive areas such as the external urethral orifice and the bladder neck, thereby greatly improving the comfort of the patient during indwelling and reducing the sense of foreign body and irritation.

[0060] In this embodiment, the operation joint at the proximal end of the catheter body 1 (i.e., the end held by medical staff for operation) has a structure for preventing wrong operation.

[0061] Specifically, two independent filling ports 6 are provided on the operation joint. Among them, the first filling port 6 is connected to the first annular channel 201 that communicates with the positioning balloon 3 and is used for filling and draining the positioning balloon 3; the second filling port 6 is connected to the second annular channel 401 that communicates with the elastic anchoring sleeve 4 and is used for opening and releasing the tube body anchoring function.

[0062] To ensure that the operator can clearly distinguish these two ports with completely different functions and avoid injecting fluid into the wrong channel due to confusion (for example, injecting a large amount of liquid for the anchoring sleeve into the positioning balloon 3 with a very small volume by mistake), the two filling ports 6 are different in at least one of the following features: different color markings; or, mutually exclusive mechanical interface configurations.

[0063] In a specific implementation, the two filling ports 6 are given prominent and completely different color identifications. For example, the first filling port 6 can be identified as blue, while the second filling port 6 is identified as yellow. This intuitive visual distinction provides a first-level of safety guarantee for medical staff to quickly identify, enabling them to confirm by color before connecting the filling device. The color identification can be achieved by injection molding the port itself with materials of different colors, or by attaching color rings or imprints of different colors to the port.

[0064] In a more preferred embodiment, the two filling ports 6 have mutually exclusive mechanical interface configurations. This is a physical anti-mistake design that makes incorrect connections physically impossible.

[0065] For example, the first filling port 6 can adopt an international standard Luer lock connector and can be connected to any standard syringe. The second filling port 6 is a non-standard special mechanical interface, such as a bayonet connector that needs to be rotated by a specific angle to lock, or a keyed connector with special concave and convex grooves. Based on this, only a matching filling device can be connected to the second filling port 6. Conventional syringes cannot be connected due to physical shape mismatches, thus fundamentally eliminating the risk of misinjecting fluid into the second annular channel 401.

[0066] In this embodiment, between the proximal end of the positioning balloon 3 and the distal end of the elastic anchoring sleeve 4, a preset neck length is axially spaced along the catheter body 1.

[0067] This neck length is specifically manifested as a common tube body section on the structure of the catheter body 1 that does not have an expansion function, so as to effectively separate the positioning balloon 3 and the elastic anchoring sleeve 4 in space.

[0068] In standard clinical catheterization operations, the positioning balloon 3 is filled and then gently pulled back until it is reliably blocked by the patient's bladder neck. Based on this standard operation, due to the existence of this neck length, when the positioning balloon 3 is blocked by the bladder neck, the entire elastic anchoring sleeve 4 is arranged in its preset working area - that is, within the patient's urethra. This ensures that the tube body anchoring function can play a role on the correct physiological structure, thereby providing an effective fixing force.

[0069] In this embodiment, in order to cope with rare but serious equipment failure situations that may occur clinically, an emergency pressure relief structure 7 communicating with the first annular channel 201 is provided at the proximal end of the catheter body 1 (i.e., the end held and operated by medical staff).

[0070] Throughout the entire normal life cycle of the urinary catheter, including insertion, indwelling, and normal fluid drainage and removal, the emergency pressure relief structure 7 is functionally completely "invisible", and its internal passage maintains an absolute sealed state, without causing any interference to the normal filling and pressure maintenance of the positioning balloon 3.

[0071] However, when a malfunction occurs in the normal filling valve of the positioning balloon 3, such as being blocked by saline crystals or blood clots, resulting in the inability to draw out the liquid in the positioning balloon 3 through normal means, and further causing the urinary catheter to be unable to be removed, the emergency pressure relief structure 7 is then enabled as the final solution.

[0072] Among them, the emergency pressure relief structure 7 is configured to be permanently opened through an irreversible mechanical operation.

[0073] In a specific embodiment, the emergency pressure relief structure 7 can be a small side pipeline that is heat-sealed and blocked beside the main valve. In an emergency, medical staff only need to cut this side pipeline with scissors to immediately create an irreparable open channel.

[0074] Alternatively, in a specific embodiment, the emergency pressure relief structure 7 can be a plastic knob or pull ring with a preset weak point. When a specific torque or pulling force exceeding normal operation is applied, this weak point will break, thereby permanently opening the hidden internal pressure relief passage.

[0075] Furthermore, in a specific embodiment, the emergency pressure relief structure 7 can be a diaphragm made of soft rubber or silica gel that is easy to puncture. In an emergency, medical staff can directly puncture this diaphragm with a standard syringe needle to establish a drainage path directly communicating with the first annular passage 201.

[0076] Although the embodiments of the present invention have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A variable-diameter catheter, characterized in that, Comprising: A catheter body having a urinary catheterization channel therein; A first sleeve coaxially sleeved outside the catheter body and defining a first annular channel with the outer wall of the catheter body, the first annular channel communicating with a positioning balloon provided at the end of the catheter body; An elastic anchoring sleeve coaxially sleeved outside the first sleeve and defining a second annular channel with the outer wall of the first sleeve; And a pressure release structure communicating with the second annular channel and configured to be in an open state or a closed state based on the fluid pressure in the second annular channel.

2. The variable-diameter catheter according to claim 1, wherein The pressure release structure is a valve assembly, and the valve assembly includes: A valve seat fixed to the elastic anchoring sleeve and forming a fluid communication with the second annular channel; And an elastic pressure release member installed in the valve seat; Wherein, an outlet end of the pressure release member forms a pair of valve lips that are mutually attached by their own elasticity in a natural state; And, only when the fluid pressure in the second annular channel overcomes the elasticity of the valve lips, the pair of valve lips opens to release pressure.

3. The variable-diameter urinary catheter according to claim 2, wherein An annular flow collecting cavity is defined inside the valve seat, the annular flow collecting cavity is used for collecting the fluid released by the pressure release member, and the outlet end of the pressure release member is located in the annular flow collecting cavity.

4. The variable-diameter urinary catheter according to claim 3, wherein At least a part of the annular flow collecting cavity is defined by an elastic wall surface, and the elastic wall surface is configured to undergo a recoverable expansion deformation due to accommodating the fluid when the pressure release member releases the fluid.

5. The variable-diameter urinary catheter according to claim 4, wherein The elastic wall surface includes a thin-wall region with a thickness smaller than its peripheral region, and the thin-wall region is configured to form an externally protruding part that can be visually recognized or tactilely sensed due to preferentially undergoing elastic expansion.

6. The variable-diameter urinary catheter according to claim 1, wherein The tube wall of the elastic anchoring sleeve is configured to have an uneven wall thickness, so that after it is filled, the radial expansion profile along its axis is in an olive shape or a barrel shape with a middle diameter larger than the diameters at both ends.

7. The variable-diameter urinary catheter according to claim 1, wherein Two filling ports respectively communicating with the first annular channel and the second annular channel are provided at the proximal end of the catheter body; And, the two filling ports are different in at least one of the following features: Different color markings; Or, mutually exclusive mechanical interface configurations.

8. The variable-diameter urinary catheter according to claim 1, wherein At least one urinary catheterization hole is formed at the distal end of the urinary catheterization channel in the catheter body.

9. The variable-diameter urinary catheter according to claim 2, wherein A preset neck length is spaced along the axial direction of the catheter body between the proximal end of the positioning balloon and the distal end of the elastic anchoring sleeve, and the neck length is configured such that when the positioning balloon is correctly positioned in the patient's bladder, the elastic anchoring sleeve is located in the urethra.

10. The variable-diameter catheter according to claim 1, wherein a proximal end of the catheter body is provided with an emergency pressure relief structure communicating with the first annular channel; wherein the emergency pressure relief structure is configured to be permanently opened by an irreversible mechanical operation.

Images