Disposable endoscope sheath assembly

Abstract

The invention relates to the technical field of medical instruments, and discloses a disposable endoscope sheath assembly which comprises a disposable sheath assembly, the disposable sheath assembly comprises an inner tube assembly, an outer tube assembly and a liquid inlet and outlet assembly, one end of the outer tube assembly is connected to the first end of the liquid inlet and outlet assembly, and an endoscope is connected to the second end of the liquid inlet and outlet assembly. The inner tube assembly comprises a transparent head sleeve, a soft isolation sleeve and a connecting tube which are sequentially connected in a sealed mode, the connecting tube is fixed in the liquid inlet and outlet assembly, the liquid inlet and outlet assembly and the outer tube assembly are arranged on the outer side of the soft isolation sleeve in a sleeving mode, the transparent head sleeve extends out of the outer tube assembly, and a lens of the endoscope sequentially penetrates through the connecting tube, the soft isolation sleeve and the transparent head sleeve. And the end face of the transparent head sleeve is abutted. According to the sheath assembly, the endoscope can be repeatedly used, the cost is reduced, postoperative treatment is convenient, and the cross infection risk is small.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a disposable endoscope sheath assembly. Background Technology

[0002] Endoscopes, as core medical devices combining diagnostic and minimally invasive treatment functions, are widely used in clinical practice. During use, they come into direct contact with human tissues or bodily fluids. To avoid cross-infection between patients due to endoscope reuse, the industry currently mainly adopts post-use processing methods such as cleaning, disinfection, and sterilization before reuse, or uses disposable endoscopes that are discarded after use. However, for reusable endoscopes, the instrument channel and distension fluid channel are integrated inside the endoscope body, resulting in a complex channel structure and narrow space, making cleaning and disinfection extremely difficult and hindering the complete removal of residual tissue debris and microorganisms. For disposable endoscopes, to meet the needs of continuous clinical diagnosis and treatment, hospitals need to maintain a certain number of disposable endoscopes to cope with replacement needs, resulting in high overall costs. Summary of the Invention

[0003] To address the aforementioned technical problems, this invention provides a disposable endoscope sheath assembly, which enables the endoscope to be reused, facilitates postoperative care, and reduces the risk of cross-infection.

[0004] The specific technical solution of the present invention is as follows: a disposable endoscope sheath assembly, comprising a disposable sheath assembly, wherein the disposable sheath assembly comprises an inner tube assembly, an outer tube assembly, and an inlet / outlet fluid assembly, one end of the outer tube assembly is connected to the first end of the inlet / outlet fluid assembly, and the endoscope is connected to the second end of the inlet / outlet fluid assembly, the inner tube assembly comprises a transparent head cover, a soft isolation sleeve, and a connecting tube that are sequentially sealed and connected, the connecting tube being fixed inside the inlet / outlet fluid assembly, the inlet / outlet fluid assembly and the outer tube assembly being sleeved on the outside of the soft isolation sleeve, the transparent head cover extending outside the outer tube assembly, and the endoscope lens sequentially passing through the connecting tube, the soft isolation sleeve, and the transparent head cover, and abutting against the end face of the transparent head cover.

[0005] In the aforementioned sheath assembly, the inlet / outlet fluid assembly serves as the connection base between the endoscope and the connecting tube. The endoscope lens extends from the connecting tube into the transparent headgear located outside the outer tube assembly, facilitating endoscope observation of the internal environment. The connecting tube, soft isolation sheath, and transparent headgear are tightly connected to form an isolation barrier, completely enclosing the endoscope lens and the portion inserted into the body, preventing contaminants such as patient tissues and bodily fluids from adhering to the endoscope surface. The soft isolation sheath is designed to accommodate the bending and rotation of the endoscope, maintaining airtightness without affecting its normal function. The outer tube assembly is fitted over the soft isolation sheath, providing support and preventing the soft isolation sheath from collapsing or twisting during insertion or operation, ensuring a smooth diagnostic and treatment process. Because the part of the endoscope inserted into the body remains in a closed space and is not contaminated, there is no need for complicated disassembly, cleaning and sterilization procedures after the operation. Only the disposable sheath component needs to be removed and replaced, which can quickly prepare for the next treatment. This allows the endoscope to be reused, reduces costs, and avoids the risk of incomplete cleaning and disinfection, thus reducing the risk of cross-infection.

[0006] Optionally, the transparent headgear has a stepped structure that abuts against the end of the outer tube assembly to restrict the transparent headgear from entering the outer tube assembly.

[0007] In the above technical solution, since the soft isolation sleeve has elastic retraction force, there is a risk that the transparent head cover will be pulled into the outer tube assembly when assembling the inner tube assembly and the outer tube assembly. The step structure is set to limit the transparent head cover from extending out of the outer tube assembly and ensure the field of vision of the endoscope lens.

[0008] Optionally, the front end face of the transparent headgear is tilted, and the tilt angle is consistent with the viewing angle of the endoscope.

[0009] In the above technical solution, the angle of the inclined surface at the front end of the transparent headgear is consistent with the viewing angle of the endoscope, so that the light-transmitting area of ​​the transparent headgear accurately covers the observation angle of the endoscope, ensuring that the lens can clearly capture the preset diagnostic and treatment field of view through the inclined surface.

[0010] Optionally, it also includes a damage inspection fixture, which includes a needle, a pressure gauge, a hose and an inflation component. The needle is provided with a sealing ring near its end. The connecting tube is a rigid tube. When the needle is inserted into the connecting tube from the second end of the inlet / outlet liquid assembly, the sealing ring on the needle seals with the inner hole of the connecting tube.

[0011] In the above technical solution, a damage inspection fixture is set up to test the sealing performance of the inner tube assembly. During the test, the disposable sheath assembly is disassembled from the endoscope, and the needle is inserted into the connecting tube to achieve a sealed connection between the damage inspection fixture and the inner tube assembly. Subsequently, a pressure of 40 kPa is applied to the tube through the inflation device, and the disposable sheath assembly is immersed in water. The presence or absence of air bubbles in the water is observed to determine whether the inner tube assembly is intact. Postoperatively, the sealing performance of the inner tube assembly is tested to determine whether the disposable sheath assembly is intact. If the sheath is damaged, the endoscope needs to be disinfected and sterilized to further reduce the risk of cross-infection.

[0012] Optionally, the outer tube assembly includes a tip, an outer tube, and a positioning head connected in sequence. A transparent head is sleeved on the outside of the tip, and the outer tube is sleeved on the outside of the flexible isolation sleeve. A water return channel is formed between the inner wall of the outer tube and the outer wall of the flexible isolation sleeve. A water return hole communicating with the outside is provided on the side wall of the outer tube near the tip. The positioning head is sealed and connected to the inlet / outlet liquid assembly. One end of the water return channel is connected to the water return hole, and the other end is connected to the outlet end of the inlet / outlet liquid assembly.

[0013] In the above technical solution, a return water channel is formed between the inner wall of the outer tube and the outer wall of the soft isolation sleeve. During the operation, the return water hole draws the surrounding waste liquid into the return water channel and discharges it out of the body through the inlet and outlet liquid assembly, ensuring the cleanliness of the treatment area and clear endoscopic vision; the sealing connection between the positioning head and the inlet and outlet liquid assembly prevents waste liquid leakage.

[0014] Optionally, the disposable sheath assembly further includes an instrument channel assembly, which includes an instrument tube A, a channel connector, an instrument tube B, a valve sleeve, and a cap connected in sequence. The valve sleeve is equipped with a one-way valve, the front end of the instrument tube A is connected to the tip, and the channel connector is located inside the inlet / outlet assembly and is connected to the inlet end of the inlet / outlet assembly.

[0015] In the above technical solution, the instrument channel assembly is used to provide an instrument passage and a fluid flow path for the endoscopic diagnosis and treatment process. When the endoscope is inserted into the disposable sheath assembly, the fluid enters the instrument channel assembly from the inlet / outlet fluid assembly and flows into the body at the front end of the instrument tube A. The one-way valve and the sheath cap ensure the fluid sealing. When the instrument is inserted, the instrument opens the one-way valve and enters the instrument tube B, and exits at the front end of the instrument tube A, realizing functional reuse and simplifying the structure.

[0016] Optionally, the instrument tube A is a thin-walled plastic structure that can deform when the outer wall is compressed.

[0017] In the above technical solution, when the instrument is inserted into the instrument channel assembly, the instrument tube A can be deformed by the pressure of the hard object while maintaining a constant circumference, ensuring the stability of the total space of the lumen, which meets both the requirements of instrument operation and the function of liquid delivery.

[0018] Optionally, the disposable sheath assembly further includes a connecting assembly. The endoscope is connected to the inlet / outlet fluid assembly through the connecting assembly. The connecting assembly is located at the front end of the instrument tube B. The instrument tube B is a thin-walled plastic structure that can be elastically bent and spring back relative to the axis.

[0019] In the above technical solution, the instrument tube B can bend and spring back elastically relative to the axis, so that when the endoscope is inserted into the disposable sheath assembly or connected to the inlet / outlet fluid assembly, the instrument tube B will be displaced, avoiding structural interference, facilitating assembly, and the instrument tube B is stable in shape after resetting, which can ensure the smooth insertion of the instrument.

[0020] Optionally, the outer tube assembly includes an outer tube, an instrument tube A and a flexible isolation sleeve arranged side by side inside the outer tube, and a return water channel is formed between the outer wall of the instrument tube A, the outer wall of the flexible isolation sleeve and the inner wall of the outer tube.

[0021] In the above technical solution, the outer tube supports the instrument tube A and the soft isolation sleeve, preventing them from collapsing or twisting during insertion into the body or operation. There is no need to set up a separate support structure for the instrument tube A, optimizing the internal space layout of the outer tube and achieving a compact structure. The instrument tube A and the soft isolation sleeve are arranged side by side, which can ensure sufficient space in the return water channel.

[0022] Optionally, the disposable sheath assembly further includes a connecting assembly, which includes connector A, connector B, and a locking assembly disposed on the endoscope. Connector A is connected to the inlet / outlet fluid assembly, connector A and connector B are detachably connected, and connector B and the locking assembly are interlocked by a latch and a slot.

[0023] In the above technical solution, when connecting the endoscope to the disposable sheath assembly, the locking component is first engaged with the connector B. The connector A and the inlet / outlet liquid assembly are in a pre-installed and fixed state. The connection between the connector B and the connector A can realize the connection between the endoscope and the inlet / outlet liquid assembly without the need for additional fasteners, thus achieving rapid positioning and assembly of the disposable sheath assembly and the endoscope.

[0024] Compared with the prior art, the present invention has at least the following advantages: (1) Since the part of the endoscope inserted into the body is in a closed space and is not contaminated, there is no need for complicated disassembly, cleaning and sterilization after the operation. Only the disposable sheath component needs to be disassembled and replaced, which can quickly prepare for the next treatment. Thus, after the operation, only the disposable sheath component needs to be replaced, and the endoscope can continue to be used for surgery. There is no need for cleaning and sterilization and other post-processing procedures, which saves the time required for post-processing, improves the efficiency of surgery, and eliminates the risk of infection caused by incomplete post-processing. (2) The disposable sheath assembly has a dual channel, which can realize the functions of water inlet and outlet and instrument insertion. Compared with the disposable endoscope, it is more complete and convenient for surgical operation. At the same time, the instrument channel and the water inlet channel share the same channel, realizing functional reuse and simplifying the structure. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the connection between the disposable sheath assembly of the present invention and the endoscope; Figure 2 This is a schematic diagram of the structure of the disposable sheath assembly of the present invention; Figure 3 yes Figure 2 A magnified view of a section at point A in the middle; Figure 4 yes Figure 2 Cross-sectional view at point B in the middle; Figure 5 This is a schematic diagram of the connection state between the disposable sheath assembly and the damage inspection fixture of the present invention; Figure 6 This is a schematic diagram of the inner tube assembly of the present invention; Figure 7 This is a schematic diagram of the outer tube assembly of the present invention; Figure 8 This is a schematic diagram of the structure of the instrument channel assembly of the present invention; Figure 9 This is a schematic diagram of the structure of the connecting component of the present invention; Figure 10 This is a schematic diagram of the structure of the endoscope of the present invention; Figure 11 This is a schematic diagram of the structure of the damage inspection tooling of the present invention; Figure 12 This is a cross-sectional view of the disposable sheath assembly of the present invention connected to the endoscope in place; Figure 13 This is a cross-sectional view of the initial connection between the disposable sheath assembly of the present invention and the endoscope.

[0026] In the diagram: 1. Disposable sheath assembly; 1.1. Inner tube assembly; 1.1.1. Transparent headgear; 1.1.2. Soft isolation sleeve; 1.1.3. Connecting tube; 1.1.4. Stepped structure; 1.2. Outer tube assembly; 1.2.1. Tip; 1.2.2. Outer tube; 1.2.3. Positioning head; 1.2.4. Return water hole; 1.3. Connecting assembly; 1.3.1. Connector A; 1.3.2. Connector B; 1.3.3. Locking pin; 1.3.4. Pass-through part; 1.4. Instrument channel assembly; 1.4.1. Instrument tube A; 1.4.2. Channel connection 1.4.3. Instrument tube B; 1.4.4. Valve sleeve; 1.4.5. Cap; 1.4.6. Check valve; 1.5. Inlet / outlet assembly; 1.5.1. Inlet valve; 1.5.2. Rotary seat; 1.5.3. External connecting seat; 1.5.4. Elastic seal; 1.5.5. Outlet valve; 1.5.6. Inlet end; 1.5.7. Outlet end; 2. Endoscope; 2.1. Locking assembly; 2.1.1. Slot; 3. Damage inspection fixture; 3.1. Needle; 3.2. Pressure gauge; 3.3. Hoses; 3.4. Inflation component; 3.5. Sealing ring. Detailed Implementation

[0027] The present invention will now be described through specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Variations and advantages that can be conceived by those skilled in the art without departing from the spirit and scope of the inventive concept are included in the present invention, and the scope of protection of the present invention is defined by the appended claims and any equivalents thereof.

[0028] Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Unless otherwise specified, the raw materials and equipment used in this invention are conventional in the art and can be obtained through conventional commercial means; unless otherwise specified, the methods used in this invention are conventional methods in the art.

[0029] In the following embodiments, "front end" and "first end" refer to the end facing the inside of the human body during surgery; "rear end" and "second end" refer to the end away from the inside of the human body during surgery.

[0030] Example 1: Refer to Figure 1 to Figure 13As shown, the present invention provides a disposable endoscope sheath assembly, including a disposable sheath assembly 1. The disposable sheath assembly 1 includes an inner tube assembly 1.1, an outer tube assembly 1.2, and an inlet / outlet assembly 1.5. One end of the outer tube assembly 1.2 is connected to the first end of the inlet / outlet assembly 1.5, and the endoscope 2 is connected to the second end of the inlet / outlet assembly 1.5. The inner tube assembly 1.1 includes a transparent head cover 1.1.1, a soft isolation sleeve 1.1.2, and a connecting tube 1.1.3 connected in sequence and sealed together. The connecting tube 1.1.3 is fixed inside the inlet / outlet assembly 1.5. The inlet / outlet assembly 1.5 and the outer tube assembly 1.2 are sleeved on the outside of the soft isolation sleeve 1.1.2. The transparent head cover 1.1.1 extends out of the outer tube assembly 1.2. The lens of the endoscope 2 passes through the connecting tube 1.1.3, the soft isolation sleeve 1.1.2, and the transparent head cover 1.1.1 in sequence and abuts against the end face of the transparent head cover 1.1.1. Endoscope 2 can be an electronic endoscope or an optical endoscope.

[0031] In this embodiment, the inner tube assembly 1.1 adopts a split structure, consisting of a transparent headgear 1.1.1, a soft isolation sleeve 1.1.2, and a connecting tube 1.1.3 sealed and glued together. In other embodiments, the inner tube assembly 1.1 can be manufactured using an integrated molding process, i.e., the transparent headgear 1.1.1, the soft isolation sleeve 1.1.2, and the connecting tube 1.1.3 are integrally formed by injection molding or other methods. The transparent headgear 1.1.1 is made of transparent plastic with a light transmittance of ≥90%, such as PMMA, PC, or PET. The connecting tube 1.1.3 is made of a rigid material, meaning it can maintain its shape stability under stress and is not prone to deformation or collapse. Simultaneously, it serves as a precise assembly reference, providing rigid support for related components such as the soft isolation sleeve 1.1.2.

[0032] In the aforementioned sheath assembly, the inlet / outlet fluid assembly 1.5 serves as the connecting base between the endoscope 2 and the connecting tube 1.1.3. The lens of the endoscope 2 extends from the connecting tube 1.1.3 into the transparent headgear 1.1.1 located outside the outer tube assembly 1.2, facilitating observation of the internal condition by the endoscope 2. The connecting tube 1.1.3, the soft isolation sheath 1.1.2, and the transparent headgear 1.1.1 form a sealed barrier, completely enclosing the lens of the endoscope 2 and the portion inserted into the body, preventing contaminants such as patient tissues and body fluids from adhering to the surface of the endoscope 2. The design of the soft isolation sheath 1.1.2 can accommodate the bending and rotation of the endoscope 2, maintaining a tight seal without affecting the normal function of the endoscope 2. The outer tube assembly 1.2 is fitted over the soft isolation sheath 1.1.2, providing support and preventing the soft isolation sheath 1.1.2 from collapsing or twisting during insertion or operation, ensuring a smooth diagnostic and treatment process. Since the part of the endoscope 2 inserted into the body is kept in a closed space and is not contaminated, there is no need for complicated disassembly, cleaning and sterilization procedures after the operation. Only the disposable sheath component 1 needs to be removed and replaced to quickly prepare for the next treatment. This allows the endoscope 2 to be reused, reducing costs and avoiding the risk of incomplete cleaning and disinfection, thus reducing the risk of cross-infection.

[0033] Furthermore, such as Figure 6 As shown, the transparent headgear 1.1.1 has a stepped structure 1.1.4, which abuts against the end of the outer tube assembly 1.2 to restrict the transparent headgear 1.1.1 from entering the outer tube assembly 1.2. Because the soft isolation sleeve 1.1.2 has an elastic retraction force, there is a risk that the transparent headgear 1.1.1 may be pulled into the outer tube assembly 1.2 by the soft isolation sleeve 1.1.2 during assembly of the inner tube assembly 1.1 and the outer tube assembly 1.2. Therefore, the stepped structure 1.1.4 is provided to limit the transparent headgear 1.1.1 from extending beyond the outer tube assembly 1.2, ensuring the field of view of the endoscope 2 lens.

[0034] Furthermore, the front end face of the transparent headgear 1.1.1 is tilted, and its tilt angle is consistent with the viewing angle of the endoscope 2, so that the light-transmitting area of ​​the transparent headgear 1.1.1 accurately covers the observation angle of the endoscope 2, ensuring that the lens can clearly capture the preset diagnostic field of view through the tilted surface.

[0035] The flexible isolation sleeve 1.1.2 always keeps the transparent headpiece 1.1.1 in a seamless fit. When the endoscope 2 is not inserted, the flexible isolation sleeve 1.1.2 itself is elastic, and the tension generated by its stretching will pull the transparent headpiece 1.1.1 towards the tip 1.2.1, making the two fit tightly. During the insertion of the endoscope 2, the tip of the endoscope 2 will push against the inclined surface of the transparent headpiece 1.1.1, causing a slight distance to form between the transparent headpiece 1.1.1 and the tip 1.2.1. At this time, although the stretched length of the flexible isolation sleeve 1.1.2 increases slightly, the tension remains basically unchanged due to the small distance. The transparent headpiece 1.1.1 will not fall out of the fit due to the push. Instead, under the action of this stable tension, it will smoothly switch from fitting the tip 1.2.1 to fitting tightly against the tip of the endoscope 2, ensuring that after the endoscope 2 is inserted, the transparent headpiece 1.1.1 can always fit the tip of the endoscope 2 without gaps.

[0036] In a preferred embodiment of the present invention, the disposable sheath assembly 1 includes an inner tube assembly 1.1, an outer tube assembly 1.2, a connecting assembly 1.3, an instrument channel assembly 1.4, and an inlet / outlet fluid assembly 1.5.

[0037] like Figure 4 , Figure 7 and Figure 12 As shown, the outer tube assembly 1.2 includes a tip 1.2.1, an outer tube 1.2.2, and a positioning head 1.2.3 connected in sequence. A transparent head sleeve 1.1.1 is located outside the tip 1.2.1. The outer tube 1.2.2 is fitted around the soft isolation sleeve 1.1.2. A return water channel is formed between the inner wall of the outer tube 1.2.2 and the outer wall of the soft isolation sleeve 1.1.2. A return water hole 1.2.4 communicating with the outside is provided on the side wall of the outer tube 1.2.2 near the tip 1.2.1. The positioning head 1.2.3 is sealed and connected to the inlet / outlet liquid assembly 1.5. One end of the return water channel is connected to the return water hole 1.2.4, and the other end is connected to the outlet end 1.5.7 of the inlet / outlet liquid assembly 1.5. The tip 1.2.1 connects to the instrument channel assembly 1.4 and fixes the transparent headgear 1.1.1. The outer tube 1.2.2 is a metal tube used to strengthen the insertion components. The front end of the outer tube 1.2.2 has return water holes 1.2.4 for discharging waste fluid. A return water channel is formed between the inner wall of the outer tube 1.2.2 and the outer wall of the soft isolation sleeve 1.1.2. During surgery, the return water holes 1.2.4 draw surrounding waste fluid into the return water channel and discharge it through the inlet / outlet assembly 1.5, ensuring a clean treatment area and a clear view for the endoscope 2. The positioning head 1.2.3 is sealed to the inlet / outlet assembly 1.5 to prevent waste fluid leakage. When the lens of the endoscope 2 is inserted into the soft isolation sleeve 1.1.2, the soft isolation sleeve 1.1.2 expands radially. After the lens of the endoscope 2 is fully inserted, the soft isolation sleeve 1.1.2 retracts, increasing the cross-sectional area of ​​the return water channel.

[0038] like Figure 8 and Figure 12 As shown, the instrument channel assembly 1.4 includes an instrument tube A1.4.1, a channel connector 1.4.2, an instrument tube B1.4.3, a valve sleeve 1.4.4, and a cap 1.4.5 connected in sequence. The valve sleeve 1.4.4 is equipped with a one-way valve 1.4.6. The front end of the instrument tube A1.4.1 is connected to the tip 1.2.1, and the rear end is connected to the channel connector 1.4.2. The channel connector 1.4.2 is located inside the inlet / outlet assembly 1.5 and is connected to the inlet end 1.5.6 of the inlet / outlet assembly 1.5. The instrument tube B1.4.3 is located at the rear end of the inlet / outlet assembly 1.5. The instrument channel assembly 1.4 provides an instrument access and fluid flow path for the endoscope 2 during diagnosis and treatment. When the endoscope 2 is inserted into the disposable sheath assembly 1, the fluid enters the instrument channel assembly 1.4 from the inlet / outlet assembly 1.5 and flows into the body through the front end of the instrument tube A1.4.1. The one-way valve 1.4.6 and the sheath cap 1.4.5 ensure fluid sealing. When the instrument is inserted, the instrument opens the one-way valve 1.4.6 and enters the instrument tube B1.4.3, and exits through the front end of the instrument tube A1.4.1, realizing functional reuse and simplifying the structure.

[0039] In the instrument channel assembly 1.4, the valve sleeve 1.4.4 and the cap 1.4.5 are connected in a sealed manner to achieve the airtightness and unidirectionality of the liquid passage. This invention does not limit the specific connection method between the two; as an example, such as... Figure 12 As shown, the cap 1.4.5 and the one-way valve 1.4.6 are made of silicone. The valve sleeve 1.4.4 has a groove, and the cap 1.4.5 has a corresponding embedded step. The groove is designed to be slightly smaller than the size of the embedded step. During assembly, a seal is formed by interference fit. In addition, a boss is provided at the position where the cap 1.4.5 and the valve sleeve 1.4.4 end face abuts to fill the gap between the cap 1.4.5 and the valve sleeve 1.4.4 end face, further blocking the path of liquid leakage from the end face gap.

[0040] In the instrument channel assembly 1.4, instrument tube A1.4.1 is a thin-walled plastic structure that can deform when its outer wall is compressed; instrument tube B1.4.3 is a thin-walled plastic structure that can bend elastically relative to its axis and spring back. When an instrument is inserted into the instrument channel assembly 1.4, instrument tube A1.4.1 can deform under the pressure of a hard object while maintaining a constant circumference, ensuring the stability of the total lumen space, thus meeting both the requirements of instrument operation and the function of liquid delivery.

[0041] like Figure 12As shown, the liquid inlet / outlet assembly 1.5 includes an inlet end 1.5.6 with an inlet valve 1.5.1, an outlet end 1.5.7 with an outlet valve 1.5.5, a rotating seat 1.5.2 connected to the inlet end 1.5.6, and an outer connecting seat 1.5.3. The rotating seat 1.5.2, the outer connecting seat 1.5.3, and the channel connector 1.4.2 are arranged in a sleeve structure from the outside to the inside. An elastic sealing element 1.5.4 is provided on the mating surface of the outer connecting seat 1.5.3 and the rotating seat 1.5.2 to seal the gap between them and prevent liquid from overflowing. External liquid flows into the inlet end 1.5.6 of the inlet / outlet assembly 1.5 through the inlet valve 1.5.1, enters the instrument tube A1.4.1 of the instrument channel assembly 1.4 through the channel holes of the rotating seat 1.5.2 and the outer connecting seat 1.5.3, and finally enters the human body through the tip 1.2.1. Meanwhile, waste fluid in the human body enters the return water channel inside the outer tube 1.2.2 through the return water hole 1.2.4, and finally flows out through the outlet valve 1.5.5 from the outlet end 1.5.7 of the inlet / outlet assembly 1.5. During the waste fluid discharge process, a certain water pressure is applied to the soft isolation sleeve 1.1.2 in the inner tube assembly 1.1, making it fit tightly against the endoscope 2, thereby increasing the water outlet area.

[0042] like Figure 2 , Figure 9 and Figure 10 As shown, the connecting assembly 1.3 includes connector A1.3.1, connector B1.3.2, and locking assembly 2.1, which is mounted on endoscope 2 and can rotate circumferentially relative to endoscope 2. Connectors A1.3.1 and B1.3.2 are respectively provided with passage portions 1.3.4 adapted to endoscope 2. Connector A1.3.1 is connected to inlet / outlet fluid assembly 1.5. Connector A1.3.1 and connector B1.3.2 are inserted into each other. After they are connected, their respective passage portions 1.3.4 are aligned to form a continuous channel, reserving axial displacement space for the insertion of endoscope 2. Connector B1.3.2 and locking assembly 2.1 are interlocked by a latch 1.3.3 and a slot 2.1.1, so that endoscope 2 is connected to disposable sheath assembly 1. The locking pin 1.3.3 of the connector B1.3.2 is provided in the passage 1.3.4, and the locking groove 2.1.1 of the locking assembly 2.1 extends circumferentially.

[0043] When endoscope 2 is inserted, it can move forward axially a certain distance through the passage 1.3.4 of connector A1.3.1 and connector B1.3.2 until the locking pin 1.3.3 on connector B1.3.2 enters the slot 2.1.1 of locking assembly 2.1. Rotating locking assembly 2.1 causes the locking pin 1.3.3 to engage with slot 2.1.1, thereby restricting the axial displacement of endoscope 2 and fixing endoscope 2 to connector B.

[0044] like Figure 12 and 13As shown, the endoscope 2 is connected to the inlet / outlet fluid assembly 1.5 via the connecting component 1.3, which is located at the front end of the instrument tube B1.4.3. Because the instrument tube B1.4.3 is a thin-walled plastic structure, it can bend and spring back elastically relative to its axis. This allows the instrument tube B1.4.3 to shift when the endoscope 2 is inserted into the disposable sheath assembly 1 or connected to the inlet / outlet fluid assembly 1.5, avoiding structural interference and facilitating assembly. After the endoscope 2 is in place, the instrument tube B1.4.3 returns to its original position, ensuring smooth instrument insertion.

[0045] like Figure 4 As shown, for a compact structure, the instrument tube A1.4.1 and the flexible isolation sleeve 1.1.2 are arranged side by side inside the outer tube 1.2.2. A return water channel is formed between the outer wall of the instrument tube A1.4.1, the outer wall of the flexible isolation sleeve 1.1.2, and the inner wall of the outer tube 1.2.2. The outer tube 1.2.2 provides support for the instrument tube A1.4.1 and the flexible isolation sleeve 1.1.2, preventing them from collapsing or twisting during insertion into the body or operation. This eliminates the need for a separate support structure for the instrument tube A1.4.1, optimizing the spatial layout within the outer tube 1.2.2 and achieving a compact structure. The side-by-side arrangement of the instrument tube A1.4.1 and the flexible isolation sleeve 1.1.2 ensures sufficient space for the return water channel.

[0046] When the endoscope 2 is inserted into the disposable sheath assembly 1, the instrument tube A1.4.1 is compressed and deformed, but its height is still sufficient to accommodate the designed instrument. When the instrument is inserted into the instrument tube A, the instrument tube A elastically expands, and after the instrument passes through, the instrument tube A automatically springs back to its original position, ensuring smooth passage of the instrument while reducing the radial space occupied by the tube itself. Both the instrument tube A1.4.1 and the soft isolation sleeve 1.1.2 are elastic structures. When the instrument or endoscope lens passes through, they avoid rigid collisions through elastic yielding, avoiding the space waste caused by the rigid channel needing to adapt to the maximum outer diameter of the endoscope, and achieving efficient use of limited space.

[0047] In a preferred embodiment of the present invention, a damage inspection fixture 3 is provided that can be inserted into the disposable sheath assembly 1 to inspect its isolation effect on the endoscope 2. The damage inspection fixture 3 includes a needle 3.1, a pressure gauge 3.2, a hose 3.3, and an inflation component 3.4. The needle 3.1 has a sealing ring 3.5 near its end. The connecting tube 1.1.3 is a rigid tube. When the needle 3.1 is inserted into the connecting tube 1.1.3 from the second end of the inlet / outlet fluid assembly 1.5, the sealing ring 3.5 on the needle 3.1 seals with the inner hole of the connecting tube 1.1.3. A damage inspection fixture 3 is set up to test the sealing performance of the inner tube assembly 1.1. During the test, the disposable sheath assembly 1 is disassembled from the endoscope 2, and the needle 3.1 is inserted into the connecting tube 1.1.3 to achieve a sealed connection between the damage inspection fixture 3 and the inner tube assembly 1.1. Then, a pressure of 40 kPa is applied to the tube through the inflation component 3.4, and the disposable sheath assembly 1 is immersed in water. The presence or absence of air bubbles in the water is observed to determine whether the sealing performance of the inner tube assembly 1.1 is intact. After the procedure, the sealing performance of the inner tube assembly 1.1 is tested to determine whether the disposable sheath 1 is intact. If the sheath is damaged, the endoscope 2 needs to be disinfected and sterilized to further reduce the risk of cross-infection.

[0048] Unless otherwise specified, the raw materials and equipment used in this invention are all commonly used in the field; unless otherwise specified, the methods used in this invention are all conventional methods in the field.

[0049] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications, alterations, and equivalent transformations made to the above embodiments based on the technical essence of the present invention shall still fall within the protection scope of the present invention.

Claims

1. A disposable endoscope sheath assembly, comprising a disposable sheath assembly (1), the disposable sheath assembly (1) comprising an inner tube assembly (1.1), an outer tube assembly (1.2) and a liquid inlet and outlet assembly (1.5), one end of the outer tube assembly (1.2) being connected to a first end of the liquid inlet and outlet assembly (1.5), and an endoscope (2) being connected to a second end of the liquid inlet and outlet assembly (1.5), characterized in that the inner tube assembly (1.1) comprises, in sequence, a transparent head cover (1.1.1), a soft isolation sleeve (1.1.2) and a connecting tube (1.1.3) which are sealingly connected, the connecting tube (1.1.3) being fixed in the liquid inlet and outlet assembly (1.5), and the liquid inlet and outlet assembly (1.5) and the outer tube assembly (1.2) being sleeved on the soft isolation sleeve (1.1.2). 1.1.2) The transparent head cover (1.1.1) extends out of the outer tube assembly (1.2), the lens of the endoscope (2) passes through the connecting tube (1.1.3), the soft isolation sleeve (1.1.2) and the transparent head cover (1.1.1) in turn, and abuts against the end face of the transparent head cover (1.1.1).

2. The disposable endoscope sheath assembly of claim 1, wherein, The transparent head cover (1.1.1) is provided with a stepped structure (1.1.4) which abuts against the end of the outer tube assembly (1.2) to limit the entry of the transparent head cover (1.1.1) into the outer tube assembly (1.2).

3. The disposable endoscope sheath assembly of claim 1, wherein, The front end face of the transparent head cover (1.1.1) is obliquely arranged, and the oblique angle is consistent with the viewing angle of the endoscope (2).

4. The disposable endoscope sheath assembly of claim 1, wherein, The damage inspection tool (3) further comprises a plug (3.1), a pressure gauge (3.2), a hose (3.3) and an inflation member (3.4), the plug (3.1) is provided with a sealing ring (3.5) near the end position, the connecting tube (1.1.3) is a hard tube, and when the plug (3.1) is inserted into the connecting tube (1.1.3) from the second end of the liquid inlet and outlet assembly (1.5), the sealing ring (3.5) on the plug (3.1) is sealed with the inner hole of the connecting tube (1.1.3).

5. The disposable endoscope sheath assembly of claim 1, wherein, The outer tube assembly (1.2) comprises a first end head (1.2.1), an outer tube (1.2.2) and a positioning head (1.2.3) which are connected and communicated in turn, the transparent head cover (1.1.1) is arranged outside the first end head (1.2.1), the outer tube (1.2.2) is gap-sleeved outside the soft isolation sleeve (1.1.2), a backwater channel is formed between the inner wall of the outer tube (1.2.2) and the outer wall of the soft isolation sleeve (1.1.2), the side wall of the outer tube (1.2.2) close to the first end head (1.2.1) is provided with a backwater hole (1.2.4) which is communicated with the outside, the positioning head (1.2.3) is sealingly connected to the liquid inlet and outlet assembly (1.5), one end of the backwater channel is communicated with the backwater hole (1.2.4), and the other end is communicated with the liquid outlet end (1.5.7) of the liquid inlet and outlet assembly (1.5).

6. A single use endoscope sheath assembly according to any one of claims 1 to 4, wherein, The disposable sheath assembly (1) further comprises an instrument channel assembly (1.4), the instrument channel assembly (1.4) comprises an instrument tube A (1.4.1), a channel connecting piece (1.4.2), an instrument tube B (1.4.3), a valve sleeve (1.4.4) and a sleeve cap (1.4.5) which are connected and communicated in turn, the valve sleeve (1.4.4) is provided with a one-way valve (1.4.6) therein, the front end of the instrument tube A (1.4.1) is connected with the first end head (1.2.1), and the channel connecting piece (1.4.2) is arranged in the liquid inlet and outlet assembly (1.5) and communicated with the liquid inlet end (1.5.6) of the liquid inlet and outlet assembly (1.5).

7. The disposable endoscope sheath assembly of claim 6, wherein, The instrument tube A (1.4.1) is a thin-walled plastic structure which can be deformed when the outer side wall is extruded.

8. The disposable endoscope sheath assembly of claim 6, wherein, The disposable sheath assembly (1) further comprises a connecting assembly (1.3), the endoscope (2) is connected with the liquid inlet and outlet assembly (1.5) through the connecting assembly (1.3), the connecting assembly (1.3) is arranged at the front end of the instrument tube B (1.4.3), the instrument tube B (1.4.3) is a thin-walled plastic structure and can be elastically bent and rebounded relative to the axis.

9. The disposable endoscope sheath assembly of claim 6, wherein, The outer tube assembly (1.2) comprises an outer tube (1.2.2), the instrument tube A (1.4.1) and the soft isolation sleeve (1.1.2) are arranged side by side in the outer tube (1.2.2), and a backwater channel is formed between the outer side wall of the instrument tube A (1.4.1), the outer side wall of the soft isolation sleeve (1.1.2) and the inner wall of the outer tube (1.2.2).

10. A single use endoscope sheath assembly according to any one of claims 1 to 4, wherein, The disposable sheath assembly (1) further comprises a connecting assembly (1.3), the connecting assembly (1.3) comprises a connecting piece A (1.3.1), a connecting piece B (1.3.2) and a locking assembly (2.1) arranged on the endoscope (2), the connecting piece A (1.3.1) is connected with the liquid inlet and outlet assembly (1.5), the connecting piece A (1.3.1) is detachably connected with the connecting piece B (1.3.2), and the connecting piece B (1.3.2) and the locking assembly (2.1) are interlocked through a snap pin (1.3.3) and a snap groove (2.1.1).

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