CN107929921B

CN107929921B - Catheter device

Info

Publication number: CN107929921B
Application number: CN201711384908.7A
Authority: CN
Inventors: 向谷兮; 欧阳志伟
Original assignee: Wuhan Xunshu Technology Co ltd
Current assignee: Wuhan Xunshu Technology Co ltd
Priority date: 2017-12-20
Filing date: 2017-12-20
Publication date: 2024-08-27
Anticipated expiration: 2037-12-20
Also published as: CN107929921A

Abstract

A catheter device, characterized in that at least a part of it around a catheter drainage hole is a hard reinforcement provided with a urinary hole corresponding to the catheter drainage hole, the urinary hole having a span size in at least one direction smaller than the outer diameter of the guide wire. Preferably, the hard reinforcing piece is an embedded piece, is injection-molded in the side wall of the catheter head end and is surrounded by the material of the catheter head end; the hard reinforcing piece and the head end are split pieces, and are in interference fit and/or are adhered to an inner hole of the head end of the catheter or are sleeved outside the catheter; or the hard reinforcement is an integral piece with the head end and is made of a hard material. According to the invention, the size and shape of the urine drainage hole are limited, so that the guide wire can be prevented from falling out to damage the urethra; the urethral catheterization channel can be used as a channel for supplementing lubricant, so that the integral structure of the urethral catheter is simplified; the overall flexibility of the catheter is maintained while enhancing the local stiffness of the head end.

Description

Catheter device

Technical Field

The present invention relates to a catheter device which can ensure safety of clinical operation, lighten the overall weight, facilitate clinical operation, and simplify the overall structure.

Background

As a first generation research and development product of the present inventor, CN103861196a discloses a urine guide-out device capable of supplementing lubricant in real time, the head end of which is curved, and the internal structure is complex; the guide wire is provided with a central channel for supplementing lubricant, so that the diameter of the guide wire is increased, and the weight of the whole catheter is increased; and the central channel for supplementing the lubricant and the urethral catheterization channel are independent and cannot be used simultaneously, so that the overall structure of the urethral catheter is complicated.

To better meet the market demand, the present inventors have started to develop second generation products within the industry and have not so far retrieved the same or similar disclosures as the present invention.

CN201375745Y discloses a catheter with an internal guide wire to enhance the rigidity of the catheter to facilitate insertion into the urethra. However, most catheters currently used clinically are rubber or silica gel products, and these two substances have extremely high stretch deformability, so that there is always a clinical operation risk in the prior art that the diameter size of the urine excretory hole of such products may be expanded to several times under the action of external force, resulting in the guide wire penetrating out of the urine excretory hole, thereby causing clinical medical accidents.

However, in the prior art, the person skilled in the art never notices this risk and does not think about how to take precautions.

Disclosure of Invention

The invention aims to provide a catheter device which can avoid the damage of a guide wire to the urethra and ensure the safety of clinical operation.

It is a further object of the present invention to provide a catheter device which allows the catheter channel to be used as a channel for lubricant replenishment, so that the overall structure of the catheter is simplified.

It is another object of the present invention to provide a urinary catheter device that can limit the size and shape of the urine drainage hole by enhancing the local stiffness of the head end, preventing the guidewire from exiting and damaging the urethra.

It is a further object of the present invention to provide a catheter device that maintains flexibility of the circumference of the catheter while enhancing the local stiffness of the head end.

To this end, according to a first aspect of the present invention, there is provided a catheter device, characterized in that at least a part thereof around a catheter drainage hole is a rigid reinforcement provided with a catheter hole corresponding to the catheter drainage hole, the catheter hole having a span dimension in at least one direction smaller than the outer diameter of the guide wire.

Preferably, the hard reinforcing piece is an embedded piece, is injection-molded in the side wall of the catheter head end and is surrounded by the material of the catheter head end; the hard reinforcing piece and the head end are split pieces, and are in interference fit and/or are adhered to an inner hole of the head end of the catheter or are sleeved outside the catheter; or the hard reinforcement is an integral piece with the head end and is made of a hard material.

Preferably, the annular space between the inner wall of the mid-section catheter and the outer wall of the guidewire acts as a lubricant injection channel and a urine drainage channel; the front end of the guide wire is flat and is inserted into a matching hole of the head end; the stiffening member is in clearance with the guidewire, the clearance being in communication with the drainage aperture.

Preferably, one, two or more catheter drainage holes are provided, each drainage hole having a drainage volume of more than 110 ml/min.

Preferably, the embedded part is net-shaped, sheet-shaped, barrel-shaped, annular or barrel-shaped.

Preferably, the rear end of the guide wire gradually thickens towards the tail end of the catheter device; the nozzle at the front end of the guide wire is conical or trumpet-shaped; or at least one fluid channel is arranged between the space outside the peripheral surface of the guide wire and the drainage conical joint.

Preferably, the device also comprises an air bag, an air bag interface and an inflating device; and/or further comprising a washer/anti-inflammatory interface, a washer/anti-inflammatory channel, and a washer/anti-inflammatory infusion device.

Preferably, the outer wall of the catheter is photographed at the enlarged diameter section at the rear side of the drainage hole.

According to a second aspect of the present invention, there is provided a method of using a urinary catheter device, characterized in that a urinary catheter is inserted into the urinary bladder, during which time lubricant is injected into the urinary tract; inflating the balloon to closely adhering to the inner wall of the urethra; urine is extracted; and injecting a cleaning liquid into the bladder to extract residual dirty liquid in the bladder.

According to a third aspect of the present invention, there is provided a guide wire structure, characterized in that it comprises a front end of a guide wire, a guide wire and a rear end of the guide wire, the guide wire itself being of solid or hollow structure, the rear end of the guide wire having at least one channel with a connection to the tail end of a catheter device, a space outside the peripheral surface of the guide wire and a drainage cone-shaped interface; the tail end of the built-in guide wire of the catheter is provided with a connecting device for connecting a liquid injection device or a urine collecting bag; a gap or channel is arranged between the rear end of the guide wire and the tail drainage cone-shaped interface of the catheter so that liquid flows into or out of the catheter.

According to the catheter device, the damage of the guide wire to the urethra can be avoided, and the safety of clinical operation is ensured; the urethral catheterization channel can be used as a channel for supplementing lubricant, so that the integral structure of the urethral catheter is simplified; the size and shape of the urine excretory hole can be limited by enhancing the local rigidity of the head end, so that the guide wire is prevented from being separated from the urethra to damage the urethra; the flexibility of the catheter circumference is maintained while enhancing the local stiffness of the head end.

Drawings

Fig. 1 is a schematic diagram of the principle of a urinary catheter in a working preparation according to an embodiment of the invention in a side view.

Fig. 2 is a schematic diagram of the side view of the catheter of the embodiment shown in fig. 1 in a catheterized state.

Fig. 3 is a schematic top view of the catheter of the embodiment shown in fig. 1 in a ready-to-use state.

Fig. 4 is a schematic cross-sectional view of the urinary catheter shown in fig. 3, taken along the section A-A.

Fig. 5 is a schematic cross-sectional view of the urinary catheter shown in fig. 3, taken along section B-B.

Fig. 6 is a schematic view of a partial structure of a catheter drainage hole according to another embodiment of the invention.

Fig. 7 is a schematic view of a partial structure of a catheter drainage hole according to yet another embodiment of the invention.

Fig. 8 is a schematic view of a partial structure of a catheter drainage hole according to yet another embodiment of the invention.

Fig. 9 is a schematic view of a catheter drainage hole restriction device according to an embodiment of the invention.

Fig. 10 is a schematic view of a catheter drainage hole restriction device according to another embodiment of the invention.

Fig. 11 is a schematic view showing a partial structure of a catheter drainage hole according to another embodiment of the present invention.

Fig. 12 is a schematic view showing a partial structure of a catheter drainage hole according to another embodiment of the present invention.

Fig. 13 is a schematic view showing a partial structure of a catheter drainage hole according to another embodiment of the present invention.

Fig. 14 is a schematic view showing a partial structure of a catheter drainage hole according to another embodiment of the present invention.

Fig. 15 is a schematic view showing a partial structure of a catheter drainage hole according to another embodiment of the present invention.

Fig. 16 is a schematic view of a guidewire assembly structure according to one embodiment of the invention.

Fig. 17 is a schematic diagram of the structure of an interface support disc according to an embodiment of the present invention.

Fig. 18 is a schematic view of the structural principle of one embodiment of a nozzle for a guidewire.

Fig. 19 is a schematic view of a guidewire assembly according to another embodiment of the present invention.

Fig. 20 is a schematic view of the structure of an interface support disc according to another embodiment of the present invention.

Detailed Description

As shown in fig. 1, in a ready-to-catheterization state, a guidewire 20 is inserted into an inner bore of a urinary catheter 10, according to an embodiment of the invention; a drainage hole limiting device 21 connected with the guide head 30 is inserted into the catheter 10; the front end 24 of the guide wire 20 is flat and is inserted into the oblong hole of the front end 25 of the excretory orifice-limiting device 21, so that the guide wire 20 does not rotate relative to the excretory orifice-limiting device 21; the lubricant bore 31 of the guide head 30 is axially aligned with the central bore of the guide wire 20; the drain hole 22 of the drain hole stop means 21 is radially aligned with the drain hole 11 of the urinary catheter 10; a gap 23 is arranged between an inner hole at the rear end of the drain hole limiting device 21 and the guide wire 20, and the gap 23 is communicated with the drain hole 22; the trailing end 26 of the guidewire 20 expands slightly from front to back; the tail end of the guide wire 20 is fixedly connected with a connecting frustum of the interface 40 of the guide wire operating handle 60; the tail end 12 of the catheter 10 is sealed on the conical surface of the connection frustum of the interface 40 by the interface 40 in threaded fit through the locking sleeve 41; a lubricant reservoir 50 is mounted to the guidewire operating handle 60, the lubricant reservoir 50 being in communication with the interior bore of the guidewire 20.

As shown in fig. 2, in the catheterized state, the guidewire operating handle 60 and its interface 40 are removed, the guidewire 20 is withdrawn, and the interface 70 of the urine bag 80 is replaced; the catheter 10 is brought into a catheterized condition, in which the drainage channel 71 of the hub 70 communicates with the urine bag 80 via a catheter 81.

The layout of the air bag 13, the inflation channel 14, the inflation seat 15, and the inflator 16 is more clearly shown in fig. 3. The air bag 13 is provided at the rear side of the drain hole 11; the inflation channel 14 is disposed in the sidewall of the urinary catheter 10; the inflatable seat 15 is arranged at a position close to the tail end 12 of the catheter 10; the inflator 16 is connected to and in gaseous communication with the inflation seat 15. In addition, an anti-inflammatory or cleansing liquid channel 17 is also provided in the sidewall of the urinary catheter 10; an anti-inflammatory or cleaning solution injection site 18 is disposed on the catheter 10 proximal to the tail end 12; an anti-inflammatory or cleaning fluid injector 19 communicates with an anti-inflammatory or cleaning fluid injection seat 18.

Fig. 4 and 5 more clearly show the anti-rotation design of the guidewire 20 through a flat mating structure.

As shown in fig. 6, according to another embodiment of the invention, the drainage hole restriction device 21 can also be built into the side wall of the urinary catheter 10, as can be done by means of a one-piece casting process. The drain hole 11 doubles as an outlet for lubricant, anti-inflammatory agent, cleaning liquid, etc., eliminating the lubricant passage 31.

As shown in fig. 7, according to yet another embodiment of the present invention, the drainage hole restriction device 21 can also be built into the inner wall of the urinary catheter 10, as can be achieved by means of a one-piece casting process. Similarly, the drain hole 11 doubles as an outlet for lubricant, anti-inflammatory agent, cleaning liquid, or the like, eliminating the lubricant passage 31.

As shown in fig. 8, according to still another embodiment of the present invention, the drain hole stopper 21 may be built in the inner wall of the guide head 30, which may be achieved using an integral casting process, with the lubricant channel 31 reserved. A broken and enlarged diameter section 5 is arranged at the rear side of the drain hole 11 of the catheter 10.

Figures 9 and 10 illustrate a pre-buried drain hole limiting device according to the present invention that defines a catheter drain aperture smaller than the diameter of the guidewire, preventing the guidewire from penetrating out of the catheter drain hole and damaging the urethra. The limiting device for the drain hole can be in a net-shaped, sheet-shaped, barreled, annular structure and the like.

Fig. 11 shows an insertion-type drainage hole restriction device according to the present invention, which defines a catheter drainage aperture smaller than the diameter of the guidewire, preventing the guidewire from penetrating out of the catheter drainage hole and damaging the urethra. A connecting node 123 is arranged among the catheter 10, the guide wire 20 and the guide head 30, so that the reliable adhesion of the three is ensured. With lubricant channels 31, the guide head 30 is inserted in a cylindrical shape and glued to the connection node 123 and the guide wire 20.

Fig. 12 shows another insertion-type drainage hole restriction device according to the present invention, which defines a catheter drainage aperture smaller than the diameter of the guidewire, preventing the guidewire from penetrating out of the catheter drainage hole to damage the urethra. A connecting node 123 is arranged among the catheter 10, the guide wire 20 and the guide head 30, so that the reliable adhesion of the three is ensured. Which has lubricant passages 31 and the barbed 32 configuration of the guide head 30 is inserted into and bonded to the connection node 123 and the guide wire 20. Thus, even if the glue is spread between the guide head 30 and the guide wire 20, the guide head 30 is difficult to separate from the inner hole of the guide wire 20, and the reliability of the structure is improved.

Fig. 13 shows another insertion-type drainage hole restriction device according to the present invention, which defines a catheter drainage aperture smaller than the diameter of the guidewire, preventing the guidewire from penetrating out of the catheter drainage hole and damaging the urethra. A drain hole stop 21 integral with the guide head 30 is inserted directly into and glued to the inner bore of the guide wire 20.

Fig. 14 shows another integrated drainage hole stop device according to the present invention, which defines a catheter drainage aperture smaller than the diameter of the guidewire, preventing the guidewire from penetrating out of the catheter drainage hole to damage the urethra. The drainage hole stop means 21 are directly part of the urinary catheter 10.

Fig. 15 shows another integrated drainage hole stop device according to the present invention, which defines a catheter drainage aperture smaller than the diameter of the guidewire, preventing the guidewire from penetrating out of the catheter drainage hole to damage the urethra. The drainage hole stop means 21, the catheter 10 and the guide head 30 are integrated.

As shown in the guidewire structure assembly of fig. 16, the foremost end of the guidewire 20 is a nozzle 27; the rear end of the guide wire 20 is a frustum 26, the rear side of the frustum 26 is a connection frustum 28, and the rear side of the connection frustum 28 is a threaded connection 29. The space between the outer circumference of the guidewire 20 and the inner wall of the urinary catheter 10 communicates with the urine collection bag through a support disk with a plurality of small holes at the interface 40 (see fig. 17). The nozzle 27 of the guide wire 20 is gradually flared from back to front, and the channel in the nozzle 27 is also gradually flared from back to front, in a conical or trumpet shape (see fig. 18).

As shown in the guidewire structure assembly of fig. 19, the foremost end of the guidewire 20 is a nozzle 27; the rear end of the guide wire 20 is integrally formed with a frustum 26 and a connection frustum 28, and the rear side of the connection frustum 28 is provided with a threaded connection portion 29. The space between the outer circumference of the guidewire 20 and the inner wall of the urinary catheter 10 communicates with the urine collection bag via a support disc with a large hole at the interface 40 (see fig. 20).

Currently, the materials of catheters are basically plastic materials such as silica gel, latex and the like. Under the action of external force, the catheter made of the material has extremely large stretching deformation. When a hard guide wire is applied to a patient with urethral stricture or prostatic hyperplasia to assist in catheterization, the guide wire is easy to penetrate out of a drainage hole, so that the urethra or the prostate is damaged. Therefore, the catheter drainage hole limiting device is adopted to limit the deformation of the drainage hole caused by the external force applied by the guide wire, so that the damage of the urethra and the prostate caused by the penetration of the guide wire from the catheter drainage hole is avoided.

At present, the catheter is generally provided with only two drain holes, and after the limiting device for the drain hole diameter of the catheter is added, the number of the drain holes can be increased, so that the problem of poor urinary catheterization caused by blockage of the drain holes is solved.

The catheter drainage hole limiting device is suitable for catheters made of plastic materials such as latex, silica gel and the like.

The guide wire of the present invention has two functions: a) Guiding the catheter to pass through the urethra, B) injecting lubricant by utilizing a gap between the catheter and the guide wire and a device at the rear part of the guide wire, and enabling the lubricant to enter the urethra through the catheter drainage hole, so as to reduce uncomfortable feeling to a patient when the catheter insertion operation is carried out; the guide wire in the prior art is a solid guide wire or a hollow guide wire, wherein the solid guide wire is not provided with a lubricant injection device, and the hollow guide wire is difficult to manufacture.

According to the invention, the drainage volume per drainage hole may be greater than 110 ml/min.

According to the invention, the catheter head end catheter/drainage hole limiting device can be embedded, integrated and separated;

Preferably, the pre-embedding type is that the limiting device is pre-embedded at the head end of the catheter, the drainage hole limiting device limits the drainage aperture of the catheter, and the aperture of the limiting device is smaller than the diameter of the guide wire, so that the guide wire is prevented from penetrating out of the drainage hole of the catheter to damage the urethra. The pre-buried limiting device can be in a net-shaped, sheet-shaped, barrel-shaped or annular structure;

Preferably, the catheter head end catheter/drainage hole limiting device may also be a separate type: namely, the catheter drainage hole limiting device is arranged in the catheter of the catheter or sleeved outside the catheter, the aperture of the catheter drainage hole limiting device is smaller than the diameter of the guide wire, and the guide wire is prevented from penetrating out of the urinary catheter Kong Sunshang urethra. The limiting device can be of a net-shaped, sheet-shaped, barrel-shaped or annular structure;

Preferably, the catheter head end catheter/drainage hole limiting device can also be an integrated one; the head end of the catheter is directly made of hard materials, so that the aperture of the catheter hole is smaller than the diameter of the guide wire, and the guide wire is prevented from penetrating out of the catheter Kong Sunshang urethra.

Preferably, the catheter head end catheter/drain hole limiting device can make the number of drain holes of the catheter head end two or more so as to increase the urine guiding-out rate.

Preferably, the built-in guide wire of the catheter can be solid or hollow; the outer diameter of the head end of the guide wire can be smaller than/larger than/equal to the inner diameter of the catheter, the guide wire structure can be cylindrical or have other geometric shapes, and the structure can enable liquid to flow into or flow out of the catheter through the drainage hole; the outer diameter of the middle and rear sections of the guide wire is smaller than the inner diameter of the catheter.

Preferably, the tail end of the catheter built-in guide wire is provided with a connecting device which can be connected with a liquid injection device or a urine collecting bag.

Preferably, an interface is provided between the tail end of the guide wire and the drainage cone of the tail of the catheter, and the tail end of the guide wire is provided with a gap or channel which allows liquid to flow into or out of the catheter.

Claims

1. A catheter device, characterized in that at least a part of the catheter device around a drainage hole (11) of a catheter (10) is a drainage hole limiting device (21) as a rigid reinforcement connected to a guide head (30), the drainage hole limiting device (21) being provided with a drainage hole (22) corresponding to the drainage hole (11) of the catheter (10), the drainage hole (22) having a span size in at least one direction smaller than the outer diameter of a guide wire (20);

The hard reinforcing piece is an embedded piece, is injection molded in the side wall of the catheter head end and is surrounded by the material of the catheter head end;

The front end (24) of the guide wire (20) is flat and is inserted into a flat matching hole of the head end (25) of the front end (21) of the drainage hole limiting device;

the hard reinforcement and the guide wire are provided with a gap which is communicated with the drainage hole;

The rear end (26) of the guide wire (20) expands slightly from front to back; the tail end of the guide wire (20) is fixedly connected with a connecting frustum of an interface (40) of a guide wire operating handle (60); the tail end (12) of the catheter (10) is sealed on the conical surface of the connection frustum of the interface (40) through the locking sleeve (41) by the interface (40) under the threaded fit; a lubricant container (50) is arranged on the guide wire operating handle (60), and the lubricant container (50) is communicated with the inner hole of the guide wire (20);

in the urethral catheterization state, the guide wire operating handle (60) and the interface (40) thereof are disassembled, the guide wire (20) is pulled out, and the interface (70) of the urine bag (80) is replaced; the catheter (10) enters a catheterization state, and at the moment, the drainage channel (71) of the interface (70) is communicated with the urine bag (80) through the catheter (81).

2. The catheter device of claim 1, wherein the rigid reinforcement is a separate piece from the head end, which is interference fit and/or glued into the internal bore of the catheter head end or around the outside of the catheter; or the hard reinforcement is an integral piece with the head end and is made of a hard material.

3. The catheter device of claim 1, wherein an annular space between an inner wall of the mid-section catheter and an outer wall of the guidewire acts as a lubricant injection passage and a urine drainage passage.

4. The catheter device of claim 1, wherein one, two or more catheter drainage holes are provided, each drainage hole having a drainage volume of more than 110 ml/min.

5. The catheter device of claim 2, wherein the embedment is mesh, sheet, barrel, ring, or barrel mesh.

6. The catheter device of claim 1, wherein the trailing end of the guidewire gradually thickens to the trailing end of the catheter device; the nozzle at the front end of the guide wire is conical or trumpet-shaped; or at least one fluid channel is arranged between the space outside the peripheral surface of the guide wire and the drainage conical joint.

7. The catheter device of claim 1, further comprising a balloon, a balloon interface, an inflation device; and/or further comprising a washer/anti-inflammatory interface, a washer/anti-inflammatory channel, and a washer/anti-inflammatory infusion device.