CN106474617B

CN106474617B - Combined water-lubricated urethral dilator

Info

Publication number: CN106474617B
Application number: CN201611067484.7A
Authority: CN
Inventors: 莫曾南; 李天宇
Original assignee: First Affiliated Hospital of Guangxi Medical University
Current assignee: First Affiliated Hospital of Guangxi Medical University
Priority date: 2016-11-28
Filing date: 2016-11-28
Publication date: 2022-09-02
Anticipated expiration: 2036-11-28
Also published as: CN106474617A

Abstract

The invention provides a combined water-lubricated urethral dilator, which comprises a hollow super-smooth catheter, a urethral probe sleeved outside the super-smooth catheter and a guide wire penetrating through the super-smooth catheter; the urethral probe is made of PVC material, and the surfaces of the urethral probe and the ultra-smooth catheter are covered with hydrophilic adhesive films; the guide wire is a hook-shaped guide wire with the front end having the deformation capability. The ultra-smooth catheter replaces the guide function of the guide wire on the urethral probe, so that the conditions of coiling in the urethra or prolapsing from the bladder and the like are not easy to occur; the ultra-smooth catheter can drain urine in the bladder, so that the false passage and the over-filling condition of the bladder are avoided; the hydrophilic adhesive film is modified by a non-hydrophilic material, so that the surface of equipment is lubricated, and the injury and secondary infection caused by inserting into urethra and bladder are reduced. The urethral dilator can well reduce the injury of urethral mucosa and the discomfort of urethral dilation when the urethral dilator is used, avoid the slide-out of the guide wire in the dilation process, ensure the continuous drainage of urine in bladder, and avoid the situations of urethral mucosa false passage, urethral perforation and bladder over-filling.

Description

Combined water-lubricated urethral dilator

Technical Field

The invention relates to the technical field of urethral dilators, in particular to a combined water-lubricated urethral dilator which does not need to be coated with a lubricant.

Background

With the development of urological intraluminal techniques, transurethral access has become the most important natural passage of the body for urological diagnosis and treatment. In the case of endoluminal procedures (e.g., transurethral prostatectomy, transurethral cystectomy), where the endoscope is unable to access the posterior urethra and bladder, dilation of the stenotic urethra using a urethral dilator is the most common procedure. When the urethra is expanded, a urinary surgeon inserts the traditional urethra expander into the urethra and the bladder according to the anatomical structure and operation experience of the urethra, and the male urethra with the narrow and abnormal angles is easily damaged by urethral mucosa false passage, avulsion, perforation and the like, so that complications such as urine extravasation, long-term urethral stricture and the like are caused.

Conventional urethral dilators can be classified into metal urethral dilators, hollow urethral dilators, and wire-probe-bonded metal urethral dilators. The metal urethra dilator is a commonly used dilator, comprises a series of urethra bouts made of metal materials with different thicknesses, utilizes the urethra dilator with the smaller circumference to perform primary dilation on male urethra, then uses sequentially-increased dilators to perform gradual dilation on the urethra, and realizes dilation on the male urethra under the condition of reducing the pain of a patient as much as possible.

The prior chinese patent CN201061668Y discloses a urethral dilator, which comprises at least one dilating tube and at least one guide wire, wherein the dilating tube has a through hole. The guide wire comprises two head ends, a hollow section and a core wire, wherein the hollow section is located between the two head ends and is formed by winding wire windings connecting the two head ends, the core wire is located in the hollow section and is at least connected with one head end, and the guide wire penetrates through the through hole and penetrates out of the top end of the expansion pipe. This structure adopts the seal wire to guide the expansion pipe and designs the expansion pipe head for the toper, avoids barriers such as the cyst of urethra inside effectively, reduces the risk that arouses the complication.

Compared with the traditional urethral dilator, the urethral dilator has the innovation of guide wire guidance, which reduces the blindness of urethral dilation, but in the process of using the guide wire to guide the dilation tube, several defects can exist: 1) the seal wire coils in the urethra, reverse or form the false way, 2) the easy slippage of seal wire guide in-process is outside to the bladder, lose its guide effect, 3) use the cystoscope to put into behind the seal wire, only when urethra dilator head end is located the bladder when expanding step by step, can carry out the drainage of urine, 4) seal wire and urethra dilator can't accomplish seamless connection, when expanding step by step, the gap between them can increase the frictional force in the urethra, damage urethra mucosa or mix with partial urethra mucosa or scar tissue, 5) when expanding step by step, urethra dilator need scribble the lubricant repeatedly, because the lubricant can be diluted by the lavage liquid in the urethra, reasons such as uneven are scribbled to the lubricant, can not furthest reduce the friction with the urethra mucosa, protect the urethra mucosa, reduce the formation of urethra scar.

The urethral dilator provided at present is mainly applied to the complicated urethral stricture dilation in men and the dilation in the transurethral operation. 1) The hook-shaped guide wire is required to be arranged to reach the bladder under the direct vision of an endoscope (such as a urethroscope, a ureteroscope and the like), the blindness of guide wire placement is reduced, and the guide wire has a hydrophilic coating to protect the mucosa to the maximum extent; 2) the hollow F6 or F8 super-slippery catheter is arranged to enter the bladder under the guidance of the hook-shaped guide wire, compared with the guide wire, a surgical assistant holds the catheter and is not easy to slip out, and the surface of the super-slippery catheter is provided with a hydrophilic adhesive film, so that the hydrophilic adhesive film is not required to be repeatedly smeared, the urine in the bladder can be continuously drained in the guidance process, and the bladder is prevented from being excessively full; 3) the urethral dilator made of the PVC material is provided with the hydrophilic adhesive film and is uniformly distributed, the lubricant does not need to be repeatedly smeared, the operation time is saved, the urethral mucosa is protected to the maximum extent, meanwhile, a connecting gap between the urethral dilator and the ultra-smooth catheter is smaller than a guide wire, and the urethral mucosa is not easily damaged and the urethral tissue is not easily involved.

Disclosure of Invention

The invention provides a combined water-lubricated urethral dilator, which makes several technical improvements in order to reduce the injury of urethral mucosa and the uncomfortable feeling of urethral dilation when the urethral dilator is used, avoid the slide-out of a guide wire in the dilation process, ensure the continuous drainage of urine in a bladder, and reduce the incidence rate of urethral false passage, perforation and bladder overfilling.

In order to achieve the technical purpose and achieve the technical effects, the invention solves the problems through the following technical scheme:

combined water lubrication urethra dilator, including urethra dilator body, the dilator body comprises three components, including hollow super-slippery pipe, the urethra dilator of the different models of cover outside the pipe, the collusion form seal wire that passes super-slippery pipe.

For the complicated, narrow male urethra, it is currently most common in the clinic to use an endoscope to place a guide wire within the bladder as a guide for a stylet. However, during the use process, the situation that the placement of the urethral dilator is influenced by factors such as the coiling in the urethra, the reverse direction or the prolapsed bladder during the guide wire guiding can occur. The invention uses the ultra-smooth catheter with the hydrophilic adhesive film to replace the guide effect of the traditional guide wire on the urethral probe, before the urethral dilator is placed, the hook-shaped guide wire is used for guiding and placing the ultra-smooth catheter, the ultra-smooth catheter is used as the guide piece of the urethral probe, and simultaneously, the real-time drainage of urine in the bladder is realized.

At present, no urethral dilator which jointly uses a hydrophilic hook-shaped guide wire, a super-smooth catheter and a water-lubricating urethral probe is available. The ultra-smooth catheter with certain hardness and circumference is used as the guide of the urethral probe, and compared with a guide wire, the condition of coiling in the urethra or falling out from the bladder is not easy to occur; the head end of the ultra-smooth catheter and the head end of the urethral probe are better embedded, and urethral mucosa is not easy to be damaged and urethral tissues are not easy to be embedded; meanwhile, the hollow ultra-smooth catheter in the inner part can drain urine in the bladder in real time, the head end of the catheter is confirmed to be positioned in the bladder through continuous urine outflow, and complications such as urethral false passage, perforation, rectal injury, excessive bladder filling and the like are reduced.

As an improvement of the combined water-lubricated urethral dilator, the ultra-smooth catheter and the urethral probe are made of PVC materials. Most of the current urethral probes are made of metal materials, have no elasticity, and are difficult to pass through the urethra with abnormal angles or stenosis. The probe has certain hardness and elasticity by adopting the PVC material; and the probe made of PVC material has moderate price, can be used as disposable consumable, and has the advantages of avoiding repeated disinfection and reducing cross infection.

As an improvement of the combined water-lubricated urethral dilator, the surfaces of the urethral probe and the ultra-smooth catheter are covered with hydrophilic adhesive films. The existing guide wire and urethral probe are embedded and need to be smeared with lubricant to reduce the injury of urethral mucosa and the discomfort during urethral expansion, and equipment coated with a hydrophilic adhesive film is adopted, so that the lubricant is not required to be added, the operation is simplified, and the operation time are shortened.

As an improvement of the combined water-lubricated urethral dilator, the hydrophilic adhesive film has a three-layer structure, wherein the first layer is a weak-polarity transition elastic protective layer tightly attached to the coated surface, the second layer is a polarity transition layer outside the elastic protective layer, and the third layer is a super-hydrophilic coating outside the polarity transition layer.

The hydrophilic adhesive film can solve the problems of excessive polarity and binding force on the surface of the PVC material and between layers, and the surface of the non-hydrophilic material is modified to have hydrophilic and lubricating surface properties, so that infection and damage of instruments inserted into a body are reduced or avoided. Meanwhile, the hydrophilic adhesive film coated with the weak-polarity transition elastic protective layer can be better suitable for PVC materials, the protective layer formed on the PVC surface by the weak-polarity elastic body on the inner layer of the hydrophilic adhesive film has the same stretching elasticity as the PVC surface, and the adhesive layer is not broken in the using process to achieve a compact protective effect.

As an improvement of the combined water-lubricated urethral dilator, the guide wire is a hook-shaped guide wire with the front end having the deformability. The guide wire adopted by the invention has a structure similar to that of a central venipuncture guide wire, the head end has high elasticity and deformation capacity, the head end is in a linear state when passing through the pipe hole and is in a natural bending state when entering the cavity, and the guide wire is not easy to have the problems of reverse direction and falling out of the bladder. The design that the guide wire head end is crooked can not only avoid the guide wire to stab the urethra, bladder mucosa when putting into, can reach the purpose that prevents the guide wire from following the bladder roll-off in the expansion process moreover.

As an improvement of the combined water-lubricated urethral dilator, the opening of the ultra-smooth catheter is positioned on the front end surface so as to facilitate the guide wire to pass through, and the end part of the ultra-smooth catheter is cone-like, so that the urethral mucosa is prevented from being damaged.

As an improvement of the combined water-lubricated urethral dilator, the front end surface of the urethral probe is of a cambered surface structure with an opening in the middle, the front part of the urethral probe is provided with a bending angle matched with the urethral structure, and the tail end of the urethral probe is provided with a handle; the bending angle is 35-40 degrees, and the length from the bending starting position to the end part is 2-5 cm.

According to the structure of the urethra, the female has few cases of using the urethral probe, has poor market prospect and is replaced by the cervical dilating strip. The urethra dilator is a device commonly used in male urinary surgery, has a good market prospect, the pubic inferior angle of the male urethra, and the bending angle matched with the urethra structure is arranged at the front part of the urethra probe, so that the discomfort of a patient in the urethra dilation operation can be reduced, and the urethra dilator conforms to the human body structure.

As an improvement of the combined water-lubricated urethral dilator, the circumference of at least one urethral probe is gradually increased. When the urethral dilator is used, the urethral probe is usually gradually increased on the gradient with the circumference of 2mm, so that the injury to the urethra caused by sudden increase is avoided. Firstly, the F12 urethral probe is placed into the urethra along the ultra-smooth catheter, and then the urethral probe is sleeved from thin to thick in sequence, so that the aim of gradually expanding the urethra is achieved on the premise of reducing discomfort of urethral expansion.

As an improvement of the combined water-lubricated urethral dilator, the front end surface of the urethral probe is of a cambered surface structure with a hole in the middle, and the tail end of the urethral probe is provided with a holding handle. The front end face adopts a smooth cambered surface structure, so that the resistance of the dilating tube inserted into the urethra is well reduced, and the urethral mucosa injury and discomfort of a patient are reduced.

As an improvement of the combined water-lubricated urethral dilator, the circumference of the urethral probe is 12-26 mm. According to the structure and the size of the urethra of a human body, the circumference of the urethral probe has a certain size range, and the urethra is expanded in the range, so that the obvious discomfort of a patient is not caused.

As an improvement of the combined water-lubricated urethral dilator, the circumference of the ultra-smooth catheter is 6-8 mm. The urethral probe is sleeved from thin to thick in sequence to achieve the purpose of gradually enlarging the urethra. The circumference of the catheter is not required to be too large, the working space of the urethral probe is reduced by exceeding 8mm, and the urethra is possibly damaged by placing the ultra-smooth catheter with a larger tube diameter; the circumference of the ultra-smooth catheter is not suitable to be too small, and the undersize catheter is easy to form a false urethral passage and cannot achieve the effect of continuous urine drainage in the bladder.

The invention has the advantages and effects that:

1. the invention uses the ultra-smooth catheter to replace the guide function of the guide wire to the urethral probe, before the urethral probe is placed, the hook-shaped guide wire is used for guiding and placing the ultra-smooth catheter, and the ultra-smooth catheter is used as the guide piece of the urethral probe. Compared with the guide wire, the ultra-smooth catheter is not easy to be coiled in the urethra or shed from the bladder; meanwhile, the ultra-smooth catheter can drain urine in the bladder in real time, the urine continuously flows out to clearly determine the position of the head end of the ultra-smooth catheter, and the incidence rate of false passage, rectal injury and excessive bladder filling in the urethra expansion process is reduced.

2. The urethra dilator coated with the hydrophilic adhesive film is adopted, the hydrophilic adhesive film can modify the surface of a non-hydrophilic material, the damage and secondary infection caused by the fact that the urethra dilator is inserted into a urethra and a bladder are reduced, the lubricating effect is guaranteed while the cost of using sterile paraffin oil is reduced, the operation is simplified, and the operation time is shortened.

3. The guide wire with the high elasticity and the deformation capacity at the head end and the ultra-smooth catheter matched with the guide wire are adopted, so that the injury of urethral mucosa when the urethral dilator is placed can be relieved, and the guide wire can be prevented from slipping out of the urethra in the dilation process.

The invention can be used for simple urethral stricture patients to realize the purpose by using a common urethral dilator, and can gradually dilate the complicated and narrow male urethra on the basis of water lubrication, thereby achieving the purpose of dilating the male urethra and facilitating the operation of endoscopic surgery. Can better meet the diagnosis and treatment requirements of transurethral operation.

The urethral dilator can better reduce the injury of urethral mucosa and the uncomfortable feeling of urethral dilation when the urethral dilator is used; the guide wire is prevented from slipping out in the expansion process, the continuous drainage of urine is ensured, and the incidence rate of the false passage and the excessive filling of the bladder is effectively reduced; reducing the incidence of cross-infection; the operation flow is simplified, and the operation time is shortened.

Drawings

FIG. 1 is a schematic view of a combination water lubricated urethral dilator;

FIG. 2 is a schematic view of a guidewire;

FIG. 3 is a schematic view of a catheter;

fig. 4 is a schematic view of a urethral sound.

And (3) identifying the figure number: 10. urethral probe, 11, bending angle, 12, handle, 20, guide wire, 30 and catheter.

Detailed Description

The present invention will be further described with reference to the following examples, but the present invention is not limited to these examples.

As shown in fig. 1 and fig. 4, the dilator body of the combined water-lubricated urethral dilator in this embodiment includes a PVC urethral sound 10 which can be used as a disposable device, the urethral sound 10 is hollow, the front end of the urethral sound is round, the tail end of the urethral sound is provided with a wing-shaped handle 12 which is convenient to hold, and the shape of the handle 12 is similar to that of the conventional urethral sound 10. The 3cm position of the front end part of the urethral probe 10 is bent upwards to form a bending angle 11 of 37 degrees, and the bending angle 11 is matched with the male urethra and pubic bone structure. If a straight tube probe is adopted, the angle of the urethra needs to be adjusted to adapt to the shape of the probe, so that the urethra is in an unnatural state, and discomfort of a patient is caused.

The urethral sound 10 of the whole set is designed in the embodiment, the circumference of the urethral sound 10 is respectively 12mm, 14mm, 16mm, 18mm, 20mm, 22mm, 24mm and 26mm, and the diameters are gradually increased by 2 mm. When the urethra is expanded, the urethral probe 10 needs to be gradually increased in a small range, otherwise, the urethral injury infection caused by the sudden increase of the circumference of the probe can occur.

As shown in the attached figures 1 and 3, a hollow super-smooth catheter 30 is sleeved in the urethral sound 10, the front end part of the catheter 30 is round, and the circumference diameter of the catheter 30 is 6mm or 8 mm. The circumference of the ultra-smooth catheter 30 is not too large, which can cause damage to the unexpanded urethra; the circumference should not be too small, which can not achieve the effect of continuous drainage of urine, and may also cause false passage and over-filling of bladder.

As shown in fig. 1 and 2, the hooked guide wire 20 at the front end has a length larger than that of the catheter 30 and the urethral probe 10, and can smoothly pass through the catheter 30. The front end of the guide wire 20 has good deformability, is in a linear state when passing through the catheter 30, and is in a natural bending state when entering the bladder or being withdrawn from the catheter.

The surfaces of the urethral probe 10, the guide wire 20 and the catheter 30 are all covered with hydrophilic adhesive films, and the hydrophilic performance of the components is changed through the hydrophilic adhesive films. The urethral probe 10, the guide wire 20 and the catheter 30 are ensured to be lubricated on the surface after being placed, the damage to the inner cavity of the urethra is reduced, and meanwhile, the use of lubricants such as sterile paraffin oil is reduced.

The hydrophilic adhesive film can adopt various coatings capable of changing the surface hydrophilic performance of the component, and the embodiment adopts the hydrophilic adhesive film which has a three-layer structure and is suitable for PVC materials. The first layer of glued membrane is the transition elasticity inoxidizing coating of weak polarity that closely laminates with the surface of being paintd, and the transition elasticity inoxidizing coating of weak polarity is made by the glue solution that has the weak polar body of strong bonding performance with PVC, and the glue solution component of this embodiment is: 8% of weak-polarity elastomer polyvinyl chloride and 98% of mixed solvent I; the mixed solvent I comprises the following components: 30% of petroleum ether, 30% of acetone and 40% of ethyl acetate.

The second layer is a polar transition layer outside the elastic protective layer, is prepared by compounding and co-melting a low-polarity elastomer and a polar adhesive and adding a softener and/or a water-retaining agent. The components of the polarity transition layer in this embodiment are: 3% of weak-polarity elastomer polyvinyl chloride, 5% of polar binder polydopamine, 1.0% of glycerol and 91% of a mixture solution; the mixed agent solution II comprises the following components: 20% of acetone, 30% of ethyl acetate, 40% of isopropanol and 10% of ethanol.

The third layer is a super-hydrophilic coating outside the polar transition layer, the super-hydrophilic coating is formed by dissolving a polar binder and a water-soluble polymer by using a mixed solvent III, adding a proper amount of a softening agent to obtain a lubricating coating solution, adding a proper amount of an antibacterial agent and an analgesic agent, uniformly mixing and coating the mixture outside the polar transition layer. The components of the super-hydrophilic coating in this example were: 3% of polar binder polydopamine, 5% of water-soluble polymer sodium alginate, 1% of softening agent, 1.0% of antibacterial agent glucosamine quaternary ammonium salt, 1.0% of analgesic lidocaine and 89.0% of mixed solvent; the mixed solvent III comprises the following components: 20% of isopropanol, 50% of ethanol and 30% of methanol. The hydrophilic adhesive film has the same stretching elasticity with the surface of the PVC material, and can achieve better compact protection effect.

The working principle of the embodiment is as follows:

firstly, the endoscope is placed into a urethra to be expanded, the narrow part of the urethra and the bladder are observed through the endoscope, the hook-shaped guide wire 20 is slowly placed into the urethra and the bladder with the assistance of the endoscope, after the guide wire 20 is placed in the bladder, the endoscope body for observation is drawn out, and the endoscope can be used by using a urethroscope or a ureteroscope.

Then, the ultra-smooth catheter 30 is sleeved from the tail end of the guide wire 20, the ultra-smooth catheter 30 is placed to the bladder by the guiding function of the guide wire 20, the guide wire 30 is taken out from the urethra after urine flows out of the ultra-smooth catheter 30, and the catheter 30 can be determined to be placed in the bladder cavity.

Further, the guiding function of the ultra-smooth catheter 30 is performed, and the urethral sound 10 with the smallest circumference is placed into the urethra to reach the bladder through the stenosis. After this operation, the catheter 30 cannot be removed, and the catheter 30 needs to guide the urethral probe 10 of the next stage of circumference and ensure continuous drainage of bladder urine.

The urethral sound 10 with the smallest first-order circumference enters the human bladder and exits the urethral sound in the opposite operation steps as the urethral sound is put in. The same operation is repeated, and the urethral probes 10 with the increased circumference are sequentially placed for gradual expansion. When the urethral probe 10 to be used reaches the maximum suitable circumference, the urethral probe is left for 10 minutes and then withdrawn. The narrow urethra of the patient is periodically dilated according to the disease condition, so that a better treatment effect can be achieved.

The embodiments of the present invention are described in detail above with reference to the accompanying drawings, but are not limited to the described embodiments. Many changes, modifications, substitutions and alterations to these embodiments are within the scope of the present invention without departing from the principles and spirit of the invention.

Claims

1. Modular water lubrication urethra expander, including the expander body, its characterized in that: the dilator body consists of three components, including a hollow ultra-smooth catheter (30), a urethral probe (10) sleeved outside the ultra-smooth catheter (30), and a hook-shaped guide wire (20) penetrating through the ultra-smooth catheter (30);

the opening of the ultra-smooth guide pipe (30) is positioned on the front end surface; the front end surface of the urethral probe (10) is of a cambered surface structure with an opening in the middle, the front part of the urethral probe (10) is provided with a bending angle (11) matched with the urethral structure, and the tail end of the urethral probe is provided with a handle (12); at least one urethral probe (10) with a gradually increasing circumference;

the urethral probe (10) and the ultra-smooth catheter (30) are covered with a hydrophilic adhesive film, the hydrophilic adhesive film has a three-layer structure, the first layer is a weak-polarity transition elastic protective layer tightly attached to the coated surface, the second layer is a polarity transition layer outside the elastic protective layer, and the third layer is an ultra-hydrophilic coating outside the polarity transition layer.

2. The combined water-lubricated urethral dilator of claim 1, wherein: the ultra-smooth catheter (30) and the urethral probe (10) are made of PVC materials.

3. The modular water-lubricated urethral dilator according to claim 1, wherein: the guide wire (20) is a hook-shaped guide wire with the front end having deformation capacity.

4. The modular water-lubricated urethral dilator according to claim 1, wherein: the angle of the front bending angle (11) of the urethral probe (10) is 35-40 degrees, and the length from the bending starting position to the end part is 2-5 cm.

5. A combined water-lubricated urethral dilator according to any one of claims 1 to 4, characterised in that: the circumference of the urethral probe (10) is 12-26 mm.

6. The combined water-lubricated urethral dilator according to any one of claims 1 to 4, wherein: the circumference of the ultra-smooth guide pipe (30) is 6-8 mm.