CN110721392A

CN110721392A - Disposable ureter guide sheath

Info

Publication number: CN110721392A
Application number: CN201910937666.2A
Authority: CN
Inventors: 陈伟; 叶林辉; 郑立巧; 谢正武
Original assignee: Shenzhen Tairuishi Medical Technology Co Ltd
Current assignee: Shenzhen Tairuishi Medical Technology Co Ltd
Priority date: 2019-09-29
Filing date: 2019-09-29
Publication date: 2020-01-24

Abstract

The invention discloses a disposable ureteral guide sheath, which comprises a sheath tube and an expander, wherein the sheath tube is sleeved on the expander tube, the expander tube is provided with a first guide wire channel which penetrates through the expander tube along the axial direction, the near end of the sheath tube is provided with a sheath tube joint, the near end of the expander tube is provided with an expander tube joint matched with the sheath tube joint, the far end of the expander tube is provided with an elastic guide head, the elastic guide head is provided with a second guide wire channel which penetrates through the expander tube along the axial direction and is communicated with the first guide wire channel, the expander tube comprises an elastic main body and a core column arranged in the elastic main body, the core column is made of HDPE materials, the elastic main body and the elastic guide head are of an integral connecting structure, and the elastic main body and the elastic guide head are both made of liquid silica gel. In the expansion process of the ureter, even if the ureter is bent or passes through a narrow cavity, the elastic guide head can actively deform to adapt to the cavity, so that the condition of inserting injury or puncture is effectively prevented, and the safety in use is high.

Description

Disposable ureter guide sheath

Technical Field

The invention relates to the technical field of medical instruments, in particular to a disposable ureteral guide sheath.

Background

With the popularization and application of ureteroscopes in China, urologists increasingly apply ureteroscopes to solve various ureteral diseases in clinic, and treatment methods and means are continuously improved and perfected. However, the ureter is narrow, and the difficulty in entering the ureter due to the narrow lumen of the ureter is easy to cause ureter injury, operation failure and the like, which always troubles the urologist operating the ureteroscope. The ureter guide sheath obviously reduces the damage of the ureter and improves the success rate of ureteroscope. During operation, the ureter guide sheath is adopted to expand the ureter, and then ureteroscopy or treatment is carried out.

However, the ureteral introducer sheaths currently on the market have an expansion tube made entirely of a rigid material, including a tapered insertion end. Because the insertion end has higher hardness, the harder insertion end can easily cut tissues such as a cavity channel and the like when passing through a narrow or bent cavity channel in the expansion process of the ureter. Therefore, there is a need for a ureteral access sheath that is safer to use.

Disclosure of Invention

To overcome the above-mentioned drawbacks and deficiencies of the prior art, it is an object of the present invention to provide a disposable ureteral access sheath. The expansion tube of the ureteral guide sheath is provided with the elastic guide head made of liquid silica gel, has the characteristics of softness and high elasticity, and can be actively deformed to adapt to a cavity channel even through a bent or narrow cavity channel in the expansion process of the ureteral guide sheath, so that the insertion injury or insertion penetration condition is effectively prevented, and the use safety is high. In addition, the expansion tube of the ureteral guide sheath is composed of a core column for supporting and an elastic main body for wrapping the core column, and the elastic main body is also made of liquid silica gel, is easy to be integrally connected with the elastic guide head, is firmly connected and cannot fall off.

In order to realize the purpose, the invention adopts the technical scheme that:

the utility model provides a disposable ureter guide sheath, its includes sheath pipe and expander, the sheath pipe cup joint in on the expansion pipe, the expansion pipe is equipped with along the first seal wire passageway that the axial runs through, the near-end of sheath pipe is equipped with sheath coupling, the near-end of expansion pipe be equipped with sheath coupling complex expansion coupling, the distal end of expansion pipe is equipped with the elasticity seeker, the elasticity seeker be equipped with along the axial run through and with the second seal wire passageway of first seal wire passageway intercommunication, the expansion pipe includes the elasticity main part and locates the inside stem of elasticity main part, the stem is made by the HDPE material, the elasticity main part with the elasticity seeker is connection structure as an organic whole, just the elasticity main part with the elasticity seeker is made by liquid silica gel.

The high-density polyethylene (HDPE) has higher hardness, better tensile strength and creep property and lighter specific weight than water, and the core column made of the HDPE is used for the disposable ureteral guide sheath, can play an axial supporting role, and ensures that the expansion tube has enough strength to be pushed forward for expansion. The liquid silica gel is a non-toxic flexible material, has good elasticity and is suitable for injection molding process. The invention uses liquid silica gel to make the elastic main body and the elastic guide head, on one hand, the elastic guide head has soft and high elastic characteristics, and can not damage the cavity when touching the cavity tissue, on the other hand, the elastic guide head and the elastic main body are easy to realize seamless connection because of the same material, and the use safety is higher. The elastic main body and the elastic guide head are integrally formed by injection molding by adopting the existing injection molding process, and specifically, a core column is placed in a mold, and then liquid silica gel is injected to form the elastic guide head and the elastic main body wrapping the core column by molding the liquid silica gel. Therefore, the elastic guide head and the elastic main body can be connected integrally and seamlessly, and the surface of the expansion pipe is smooth.

Preferably, the elastic guide head is conical in shape and 20-25 mm in length. The elastic seeker with the length has good overall softness and elasticity, is not easy to fall off or break, and has high use safety and good guiding and expanding effect.

Preferably, the stem is provided with at least 3, and is distributed on the periphery of the first guide wire channel in an equidistant annular array. So, can make stem evenly distributed in the inside of elastic main body to when going the expansion, make elastic main body is even in axial and radial atress, impels forward more easily, controls more easily.

Preferably, the sheath comprises a PTFE membrane layer, a spring support layer and a PA membrane layer which are sequentially arranged from inside to outside.

Preferably, the thickness of the PTFE film layer is 0.03-0.06 mm. The friction coefficient of PTFE (polytetrafluoroethylene) is extremely low, and the friction of the inner wall of the sheath can be reduced, so that the resistance of other instruments passing through the sheath is reduced. Due to the small radial size of the sheath, and the fact that ureteroscopy and other instruments can pass through the sheath is ensured. Therefore, if the thickness of the PTFE membrane layer is too large, the inner diameter of the sheath tube becomes small, which affects the passage of other instruments, but if the thickness of the PTFE membrane layer is too small, the PTFE membrane layer is easily broken. According to the invention, through series of researches, the PTFE film layer is not easy to damage when the thickness of the PTFE film layer is 0.03-0.06 mm, and the instrument can be ensured to smoothly pass through the sheath tube.

Preferably, the spring support layer is made of a developed metal. Therefore, the sheath can be visible under projection of the developing device, and operation and positioning tracking are facilitated.

Preferably, the surface of the elastic guide head is provided with a hydrophilic lubricating coating. The hydrophilic lubricious coating can significantly reduce the surface friction of the elastomeric introducer, allowing it to more easily pass through during expansion without damaging the tissue.

Preferably, the surface of the PA membrane layer is provided with a hydrophilic lubricating coating. The hydrophilic lubricious coating can significantly reduce the surface friction of the sheath, thereby greatly reducing the resistance of the ureteral access sheath to the urinary tract.

Preferably, the hydrophilic lubricating coating of the present invention is a polyvinylpyrrolidone coating. The polyvinylpyrrolidone is nontoxic, is a water-soluble biopolymer material, has hydrophilic groups, and can be combined with water to rapidly swell when contacting aqueous liquid to form hydrophilic gel, thereby showing excellent lubricity and biocompatibility.

The invention has the beneficial effects that: the expansion tube of the ureteral guide sheath is provided with the elastic guide head made of liquid silica gel, has the characteristics of softness and high elasticity, can be actively deformed to adapt to a cavity even through a bent or narrow cavity in the expansion process of the ureteral, effectively prevents the occurrence of the condition of insertion injury or insertion penetration, and has high use safety. In addition, the expansion tube of the ureteral guide sheath comprises a core column for supporting and an elastic main body for covering the core column. Because the elastic main body is also made of the liquid silica gel material, the elastic main body and the elastic guide head can be simultaneously prepared by adopting the existing integral injection molding process, so that the elastic main body and the elastic guide head are seamlessly and integrally connected, are firmly connected and cannot fall off. When the expansion pipe is expanded, the core column made of the HDPE material can play a role in axial support, so that the expansion pipe has enough strength to be pushed forward for expansion.

Drawings

Fig. 1 is a schematic structural view of a disposable ureteral access sheath according to the present invention;

FIG. 2 is a schematic structural view of the sheath according to the present invention;

FIG. 3 is a schematic structural view of the dilator of the present invention;

FIG. 4 is a cross-sectional view taken along plane A-A of FIG. 2;

fig. 5 is a sectional view taken along the plane B-B of fig. 3.

In the figure, a sheath 1, a dilator 2, a first guide wire channel 3, a sheath joint 4, a dilating tube joint 5, an elastic guide head 6, a second guide wire channel 7, an elastic main body 8, a stem 9, a PTFE membrane layer 10, a spring support layer 11, a PA membrane layer 12, and a polyvinylpyrrolidone coating layer 13.

Detailed Description

To better illustrate the objects, technical solutions and advantages of the present invention, the present invention is further described below with reference to the accompanying drawings and examples. It should be understood that the embodiments of the present invention are only for illustrating the technical effects of the present invention, and are not intended to limit the scope of the present invention.

Example 1

As shown in fig. 1 to 5, the present embodiment 1 provides a disposable ureteral access sheath, which includes a sheath tube 1 and an expander 2. Wherein, sheath pipe 1 cup joints on expansion pipe 2, and expansion pipe 2 is equipped with along the first seal wire passageway 3 that the axial runs through, and the near-end of sheath pipe 1 is equipped with sheath coupling 4, and the near-end of expansion pipe 2 is equipped with and connects 5 with sheath coupling 4 complex expansion pipe, and the distal end of expansion pipe 2 is equipped with elasticity seeker 6, and elasticity seeker 6 is equipped with along the axial run through and with the second seal wire passageway 7 of first seal wire passageway 3 intercommunication. The expanding tube 2 comprises an elastic body 8 and a stem 9 arranged inside the elastic body 8, wherein the stem 9 is made of HDPE material. The elastic main body 8 and the elastic seeker 6 are of an integral connecting structure, and the elastic main body 8 and the elastic seeker 6 are both made of liquid silica gel.

In this embodiment, the elastic guiding head 6 is tapered and has a length of 25mm (20-25 mm). The elastic seeker 6 with the length is good in overall softness and elasticity, not prone to falling off or breaking, high in use safety and good in guiding and expanding effect.

In this embodiment, there are 3 stems 9, and the stems are distributed around the first wire guide channel 3 in an equidistant annular array. The core column 9 can be provided with more than 3, preferably 3-6. So, can make stem 9 evenly distributed in elastic main body 8's inside to when going the expansion, make elastic main body 8 even in axial and radial atress, impel forward more easily, control more easily.

In this embodiment, the sheath 1 includes a PTFE membrane layer 10, a spring support layer 11, and a PA membrane layer 12 that are sequentially disposed from inside to outside. The friction coefficient of PTFE (polytetrafluoroethylene) is extremely low, and the friction of the inner wall of the sheath tube 1 can be reduced, so that the resistance of other instruments passing through the sheath tube is reduced. Due to the small radial dimension of the sheath 1, it is ensured that instruments such as a ureteroscope can pass through the sheath. Therefore, if the thickness of the PTFE membrane layer 10 is too large, the inner diameter of the sheath 1 becomes small, which affects the passage of other instruments, but if the thickness of the PTFE membrane layer 10 is too small, the PTFE membrane layer 10 is easily broken. According to the invention, through series of researches, when the thickness of the PTFE film layer 10 is 0.03-0.06 mm, the PTFE film layer 10 is not easy to damage, and the instrument can be ensured to smoothly pass through the sheath. The spring support layer 11 is made of a developing metal, such as tantalum, tungsten alloy, molybdenum alloy, gold alloy, or other metal material that can be developed under X-ray, so that the sheath 1 can be viewed under projection of a developing device, and is convenient to operate and position and track.

In this embodiment, the surfaces of the elastic seeker 6 and the PA membrane layer 12 are both provided with a polyvinylpyrrolidone coating 13. The polyvinylpyrrolidone is nontoxic, is a water-soluble biopolymer material, has hydrophilic groups, and can be combined with water to rapidly swell when contacting aqueous liquid to form hydrophilic gel, thereby showing excellent lubricity and biocompatibility.

Finally, it should be noted that the above embodiments are only used for illustrating the technical solutions of the present invention and not for limiting the protection scope of the present invention, and although the present invention is described in detail with reference to the preferred embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made on the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention.

Claims

1. The utility model provides a disposable ureter guide sheath, its characterized in that, includes sheath pipe and expander, the sheath pipe cup joint in on the expansion pipe, the expansion pipe is equipped with along the first seal wire passageway that the axial runs through, the near-end of sheath pipe is equipped with sheath coupling, the near-end of expansion pipe be equipped with sheath coupling complex expansion coupling, the distal end of expansion pipe is equipped with the elasticity seeker, the elasticity seeker be equipped with along the axial run through and with the second seal wire passageway of first seal wire passageway intercommunication, the expansion pipe includes the elasticity main part and locates the inside stem of elasticity main part, the stem is made by the HDPE material, the elasticity main part with the elasticity seeker is connection structure as an organic whole, just the elasticity main part with the elasticity seeker is made by liquid silica gel.

2. The single use ureteral access sheath of claim 1, wherein the surface of the flexible introducer is provided with a hydrophilic lubricious coating.

3. The disposable ureteral access sheath of claim 1, wherein the flexible introducer is tapered in shape and has a length of 20 to 25 mm.

4. A single-use ureteral access sheath according to claim 1, wherein said stem is provided with at least 3, and is distributed around the periphery of said first guide wire channel in an equally spaced annular array.

5. The single-use ureteral access sheath of claim 1, wherein the sheath comprises a PTFE membrane layer, a spring support layer, and a PA membrane layer arranged in this order from inside to outside.

6. The single-use ureteral access sheath of claim 5, wherein the PTFE membrane layer has a thickness of 0.03 to 0.06 mm.

7. The single use ureteral access sheath of claim 5, wherein the spring support layer is made of a contrast metal.

8. The single-use ureteral access sheath of claim 5, wherein the surface of the PA film layer is provided with a hydrophilic lubricious coating.

9. The single use ureteral access sheath of claim 2 or 8, wherein the hydrophilic lubricious coating is a polyvinylpyrrolidone coating.