Medical endoscope

By designing a flexible, elongated endoscope body and an inflatable double-capsular channel core, the existing medical endoscopes are solved for the complicated operation and tissue damage in urinary tract surgery, and the smooth endoscope is achieved shorten the operation and surgery time.

WO2025031379A1PCT designated stage expired Publication Date: 2025-02-13ANHUI HAPPINESS WORKSHOP MEDICAL INSTRUMENTS CO LTD

Patent Information

Application Number
PCT/CN2024/110285
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-08-08
Filing Date
2024-08-07
Publication Date
2025-02-13

AI Technical Summary

Technical Problem

The existing medical endoscopes are complicated to operate during urinary tract surgery, and the hard lens needs to enter the tract first, and the soft lens has problems of gap blockage and multiple retraction when working in the guide sheath, resulting in tissue damage and long surgery time.

Method used

Design a flexible elongated endoscope body with a built-in inflatable capsule and channel core. The outer side of the channel core head covers the double capsule body. The capsule is expanded by filling the fluid outside the body and expands the narrow area radially. , realize the smooth progress of the endoscope, and integrate the functions of the hard and soft mirrors to eliminate the gap in the guide sheath.

Benefits of technology

It realizes that endoscopy is used directly in the tract without the need for a hard lens in urinary tract surgery, which simplifies the operation steps, reduces tissue damage, shortens the surgical time, and improves treatment efficiency and safety.

✦ Generated by Eureka AI based on patent content.

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Abstract

A medical endoscope, comprising an elongated bendable endoscope main body (1). An optical assembly is arranged on the endoscope main body (1), and the endoscope main body is provided with a main channel (11) penetrating the head and the tail thereof. The main channel (11) is provided with a main channel internal opening (111) which enters into a human body when in use and a main channel external opening (112) which is positioned at the outside of the human body when in use. A channel core (2) is arranged in the main channel (11), and a channel core head (21) extends out of the main channel internal opening (111). An inflatable balloon (C) is sheathed on the outer side of the channel core head (21), the maximum outer diameter of the expanded balloon body (C) is greater than or equal to the outer diameter of the head of the endoscope main body (1), and a balloon inner cavity (C0) is connected to the exterior thereof by means of a balloon passage (C00) provided in the channel core (2). When the endoscope becomes stuck during insertion into a living body cavity, a fluid can be filled into the balloon (C) from the exterior of the living body so as to expand the balloon, such that the narrow position of the living body cavity can be expanded in a radial direction, thereby facilitating the continuous advancing of the endoscope main body (1) in the living body cavity.
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Description

A medical endoscope Technical Field

[0001] The present invention relates to a medical endoscope, in particular to a flexible endoscope, belonging to the technical field of medical device products. Background Art

[0002] Existing medical endoscopes are divided into hard endoscopes with slender bodies that cannot or are difficult to bend, soft endoscopes with easily bendable bodies, and combination endoscopes with a hard endoscope and a soft endoscope. Hard endoscopes are easy to enter the natural cavities or pathological sinuses of living organisms due to their high strength. Although soft endoscopes have the defect of being difficult to insert, they are more slender and soft and can contact the natural cavity for a longer time during operation, so the damage is less than that of hard endoscopes. For example, transurethral laser kidney stone surgery usually involves 1. The hard endoscope enters the bladder through the urethra; 2. Then a guide wire is inserted into the renal pelvis; 3. The ureteral guide sheath is then inserted through the guide wire; 4. The inner core of the ureteral guide sheath is pulled out; 5. The soft endoscope is then inserted from the ureteral guide sheath, and the soft endoscope is inserted into the ureteral guide sheath. The working channel of the endoscope is responsible for functions such as fiber optic lithotripsy, cooling and flushing, and stone extraction. Inserting the soft endoscope requires four steps, which is cumbersome and causes great damage to the urinary tract. The soft endoscope is placed inside the ureteral guide sheath, and the outflow pathway for small fragments after stone crushing is usually the gap between the soft endoscope and the ureteral guide sheath. Larger stones need to be removed from the body through the soft endoscope under the sheath of the stone basket and then cleaned. If the water flow is not smooth or the gap is blocked, the endoscope needs to be withdrawn in time. There are usually dozens or hundreds of endoscope withdrawal operations in one operation, which is cumbersome and time-consuming. Even with the protection of the ureteral guide sheath, the repeated advance and retreat of the soft endoscope will cause the guide sheath to swing frequently in the ureter, thereby damaging the urinary tract.

[0003] The present invention provides a medical endoscope, specifically a flexible endoscope, which can be used to perform urinary tract or other endoscope-related diagnosis and / or treatment actions directly using the flexible endoscope of the present invention without the need for complicated steps such as using a hard endoscope first.

[0004] Summary of the Invention

[0005] The object of the present invention is achieved like this:

[0006] A medical endoscope has an optical component provided on a flexible and slender endoscope body, and the endoscope body is provided with a hollow main channel running through the head and tail. The main channel has an inner main channel opening that enters the body when in use and an outer main channel opening that is located outside the body when in use. A channel core is provided in the main channel, and the head of the channel core protrudes from the inner main channel opening. The outer side of the head of the channel core is covered with an expandable capsule. The maximum outer diameter of the expanded capsule is greater than or equal to the outer diameter of the head of the endoscope body. The inner cavity of the capsule is connected to the outside through the capsule passage opened on the channel core. When the endoscope is placed in a living body cavity and encounters an obstruction, fluid can be filled into the capsule from outside the body to expand it, radially expanding the narrow part of the living body cavity, which is conducive to the endoscope body continuing to move forward in the living body cavity.

[0007] The main channel can be used for the passage of medical tools when in use, providing guidance, protection and other corresponding functions for the medical tools located therein, such as various catheters, guide wires, stone baskets, optical fibers, ultrasonic catheters, etc.; the head of the endoscope body is provided with a pressure sensor and / or a temperature sensor.

[0008] This design can combine the functions of traditional hard endoscopes and soft endoscopes; the functions of traditional guide sheaths or channel sheaths and soft endoscopes; lithotripsy can be performed under pressure and temperature monitoring, which increases the safety factor; when the traditional guide sheath is 12Fr, the soft endoscope inside it must be significantly smaller than 12Fr, such as 10Fr or thinner, while the present invention directly makes the soft endoscope into 12Fr, eliminating the space occupied by the thickness of the guide sheath wall and the gap between it and the soft endoscope, and the main channel as the internal working channel is significantly spacious, which is convenient for surgical operations. When the channel core of the present invention is used in conjunction with other applicable catheters, the endoscope body of the present invention also includes the catheter. For example, when the channel core of the present invention is used in conjunction with a sheath, the channel core can be placed in the channel of the sheath and enter the natural cavity of the human body. At this time, after the channel core is expanded, the maximum outer diameter of the capsule is greater than or equal to the outer diameter of the sheath head.

[0009] In order to be used more non-invasively in living bodies, the outer side of the channel core head is covered with an expandable capsule with a conical outer contour, so that the entire channel core head protrudes from the opening in the main channel in a conical shape; by setting ribs or a capsule wall design with a thin top and thick bottom in the capsule, the outer contour of the capsule can be conical before filling or partially filled, and the conical structure has less resistance when moving forward.

[0010] In order to insert a conventional guide wire, the channel core is hollow inside and penetrates from head to tail, and the inner cavity of the channel core allows the guide wire to pass through.

[0011] A further design is that the outer side of the channel core head is covered with two expandable capsules, namely the inner capsule and the outer capsule. The inner capsule and the outer capsule are respectively provided with an inner capsule passage and an outer capsule passage connected to the outside, and the outer capsule at least partially covers the inner capsule.

[0012] During use, the inner bladder is filled first, making the outer shape conical, which is easy to advance in the natural cavity. When encountering resistance, the outer bladder is further filled or the inner bladder is continued to be filled simultaneously to expand the narrow area. This design makes it easy to pull the channel core out of the main channel after the inner and outer bladders are unfilled.

[0013] Another design is that the outer capsule only covers the upper part of the inner capsule, while the lower area of ​​the inner capsule is directly exposed to the outside, that is, the lower area of ​​the inner capsule can contact the biological tissue when in use; the outer capsule covers the upper part of the inner capsule, and can be covered to varying degrees, but at least a part of the lower part of the inner capsule is exposed, so that the exposed lower area of ​​the inner capsule is directly exposed to the outside, and can contact the biological tissue when in use, such as the natural cavity lining, and can directly play a role of radial expansion.

[0014] In a specific solution, the outer side of the channel core head is covered with an expandable eccentric sac that is asymmetrically distributed along the axial direction. When partially filled, the outer contour of the eccentric sac is conical and protrudes from the opening in the main channel.

[0015] When the eccentric sac is partially filled, it can compensate for the geometric deviation caused by the non-centering of the main channel, and ensure the mechanical stability of the endoscope body when it moves forward; and when the resistance to advancement increases due to stenosis, the eccentric sac will be further filled to expand the stenosis; the eccentric expansion can also better adapt to the irregular shape of the natural cavity of the organism itself.

[0016] In order to optimize medical operations such as laser lithotripsy, an annular protrusion is connected to the head of the endoscope body, and the channel core head can be protruded from the upper opening of the annular protrusion.

[0017] The annular protrusion can be made of a transparent material so as not to affect light transmission; to prevent stones from damaging the lens during laser lithotripsy, the stones can also be adsorbed on the annular protrusion to release laser energy at a stable distance.

[0018] At least one notch is provided on the upper edge of the annular protrusion; the notch of the annular protrusion can be arranged singly or multiple in a wave shape. During operation, water can be discharged or returned from the notch of the annular protrusion, and small gravel can also enter the main channel through the notch of the annular protrusion and be sucked out of the body by negative pressure.

[0019] In order to reduce friction with living tissue, at least the channel core head and / or the outer surface of the endoscope body are coated with a hydrophilic coating.

[0020] An optimized parameter design is that the inner diameter of the main channel on the endoscope body is between 1.2 mm and 2.8 mm.

[0021] In order not to affect the endoscope field of view, at least the head of the channel core is transparent or translucent.

[0022] In order to achieve the effect of a hard mirror, at least a portion of the slender channel core body is made of hard material. After being inserted into the main channel of the endoscope body, it can increase at least the local strength of the endoscope, so that at least the local strength of the endoscope is close to or equivalent to that of a hard mirror.

[0023] The channel core is hard. One solution during the specific production is to select a hard material. Another solution is to set a slender cavity in the channel core and place a slender rigid guide wire in the cavity, thereby improving the overall strength of the channel core, further improving the strength of the endoscope, and achieving at least partial strength of the endoscope close to or equivalent to that of a hard endoscope. When in use, after the head of the endoscope main body reaches the target position, the at least partially hard channel core is pulled out, and the endoscope main body returns to the properties of a soft endoscope, and subsequent operations significantly reduce tissue damage.

[0024] Furthermore, an operating handle is connected to the rear end of the endoscope body, and an internal channel of the operating handle is connected to the main channel.

[0025] In order to observe flexibly in the body and eliminate blind spots in operation, a component that can actively or passively bend the head of the endoscope body is provided in the endoscope body, such as a snake bone component and a traction line.

[0026] The tail of the main channel is connected to a side branch pathway and is provided with a side branch opening; the side branch pathway is connected to the main channel, and multiple side branch pathways can be set to meet different clinical needs.

[0027] The beneficial effects of the present invention are:

[0028] 1. When passing through the narrow part of the natural cavity, the capsule of the channel core head expands radially, eliminating the local stenosis, and then the capsule of the channel core head recovers, and the soft lens head moves forward smoothly, eliminating the shear damage to the tissue when the traditional hard mirror encounters resistance when advancing axially, and replacing the function of the hard mirror.

[0029] 2. Compared with the traditional soft endoscope used in the guide sheath, the gap between the soft endoscope and the guide sheath is eliminated, and the soft endoscope and the guide sheath are integrated into one, thereby expanding the working channel of the soft endoscope and eliminating the tedious operation of multiple endoscope withdrawals, improving efficiency while reducing tissue damage.

[0030] 3. The internal channel of the operating handle is connected to the main channel of the endoscope. This axial connection method is different from the traditional use of the endoscope sheath. After the channel core is pulled out, the main channel of the endoscope can be used as a working channel. The structure is simple and the external connection pipeline is convenient. When an external negative pressure suction device is connected, the suction effect is better because there are no corners.

[0031] 4. The double-bladder design of the channel core head ensures that the inner bladder maintains a conical shape, while the outer bladder expands conformably to the natural stenosis of the cavity, ensuring smooth progress while protecting the living tissue from shear damage to the soft lens head structure to the greatest extent.

[0032] 5. The integration of hard endoscope, soft endoscope and guide sheath into one will further reduce product costs when produced in large quantities.

[0033] 6. During insertion, the head balloon can radially expand the membranous urethra to protect the external sphincter; the head balloon can radially expand the tissue at the junction of the ureter and bladder to protect the Waldeyer sheath; when the ureter is locally narrowed, the balloon can easily pass through after radial expansion, eliminating the axial shear damage at the local narrowing of the ureter caused by traditional passage methods.

[0034] 7. Stone crushing, stone removal, water flushing and other operations can be carried out under real-time monitoring of pressure and temperature, and the safety factor is significantly improved.

[0035] 8. The endoscope head can be bent automatically to observe the renal calyx without blind spots, so as to completely crush the stones.

[0036] 9. The annular protrusion protruding from the head of the endoscope can be combined with the negative pressure in the main channel to suck the stones into the opening of the annular protrusion without blocking the lens, thus safely and accurately crushing the stones. The notch on the upper edge of the annular protrusion is a water flow channel, which can be injected with water for cooling to avoid thermal damage to the tissue during laser release.

[0037] 10. The liquid outlet on the head of the endoscope sprays sterile flushing fluid to flush the gravel into the spacious main channel. The main channel is externally connected to a negative pressure suction device, which facilitates the thorough removal of the stones during the operation. Compared with the traditional postoperative procedure in which patients need to urinate for several days to excrete all the gravel, the treatment effect is significantly improved.

[0038] 11. Due to the expansion and advancement function of the channel core head capsule under visual guidance, it is not necessary to insert a guide wire in advance under normal circumstances, which reduces the patient's pain and shortens the operation time.

[0039] 12. If the insertion process requires the strength of a traditional hard endoscope, at least the hard channel core at the head can significantly improve the strength of the soft endoscope when combined with the endoscope body, so that the endoscope reaches the level of a hard endoscope or close to the level of a hard endoscope to meet clinical needs.

[0040] 13. Significantly simplifies the operation steps, reduces tissue damage, greatly saves operation time and reduces treatment costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] The accompanying drawings which do not limit the present invention are as follows:

[0042] Figure 1A: Schematic diagram of the structure of Example 1, endoscope part

[0043] Figure 1B: Cross-sectional view of the endoscope portion of Example 1

[0044] Figure 1C: Cross-sectional view of the channel core placed in the endoscope in Example 1

[0045] Figure 1D: Cross-sectional view of the channel core in Example 1 advancing to the ureteral stenosis

[0046] Figure 1E: Cross-sectional view of the expanded state of the channel core head capsule in Example 1

[0047] Figure 1F: Cross-sectional view of the process of the channel core exiting from the main channel of the endoscope in Example 1

[0048] Figure 2A: Cross-sectional view of the double-bladder structure at the head of the channel core in Example 2

[0049] Figure 2B: Cross-sectional view of the guidewire passing through the channel core in Example 2

[0050] Figure 2C: Cross-sectional view of the expanded capsule in the channel core of Example 2

[0051] Figure 2D: Cross-sectional view of the expanded outer balloon of the channel core of Example 2

[0052] Figure 2E: A cross-sectional view of an outer bladder partially invaginated with an inner bladder in Example 2, with the outer bladder expanded.

[0053] Figure 2F: A cross-sectional view of an outer bladder partially invaginated with an inner bladder in Example 2, with the inner bladder continuing to expand.

[0054] Figure 2G: A three-dimensional view of the annular protrusion on the head of the endoscope body of Example 2

[0055] Figure 3A: Cross-sectional view of the eccentric outer capsule of Example 3,

[0056] Figure 3B: Cross-sectional view of the eccentric inner capsule of Example 3

[0057] Figure 4A: Cross-sectional view of Example 4

[0058] Figure 4B: Cross-sectional view of Example 4 DETAILED DESCRIPTION

[0059] The embodiments of the present invention are not limited to the following:

[0060] Example 1:

[0061] As shown in Figures 1A-1F, a medical endoscope, a flexible and elongated endoscope body 1 is composed of a head 12, a middle part 13, and a tail 14. The tail 14 is connected to an operating handle 15 for the user to operate the endoscope. The operating handle 15 is provided with a power interface 151, a negative pressure suction side branch 10f, an optical fiber side branch 10g, and an irrigation side branch 10e. The opening 113e is connected to an external device, and the laser fiber can enter from the main channel 11 or through the fiber channel (omitted in the figure) in the wall of the endoscope body; a lens 10a, an optical window 10b and a pressure and temperature two-in-one sensor 10d are located at the top of the head 12 of the endoscope body 1; two liquid outlets 10c are distributed on opposite sides. Compared with a single liquid outlet, the relatively distributed double liquid outlets have a more uniform heat dissipation effect after the liquid is discharged and the flushing is more thorough; the liquid outlet 10c is connected to the endoscope body 1 The perfusion side branch 10e extending from the tail area of ​​the endoscope body 1 is fluid-connected; the endoscope body 1 is provided with a hollow main channel 11 running through the head and tail, as shown in FIG1B , the main channel 11 has a main channel inner opening 111 that enters the body when in use and a main channel outer opening 112 that is located outside the body when in use, the main channel outer opening 112 is connected to the internal channel 150 of the operating handle, and the external opening 151 of the internal channel 150 of the operating handle is directly connected to the outside; as shown in FIG1C , an elongated channel core 2 is sheathed in the main channel 11, and the channel core 2 is divided into a channel core head 21, a channel core middle part 22, and a channel core tail 23. When in use, most of the channel core tail 23 is placed in the internal channel 150 of the operating handle, and the channel core tail end 231 protrudes downward from the internal channel 150 of the operating handle, while the channel core head 21 protrudes upward from the main channel inner opening 111. The outer side of the channel core head 21 is covered with an expandable balloon C, and the balloon C is preferably made of a compliant material. Through the capsule inner cavity opening C01, the capsule passage C00 opened on the channel core 2 and then through the power capsule inner cavity opening P01 is connected to the inner cavity P0 of the power capsule P; as a variation of this embodiment, in order to facilitate operation, the power capsule P connected to the capsule passage C00 can be set on the operating handle 15 (not shown); in this embodiment, the internal channel 150 of the operating handle is connected to the main channel 11. This axial connection method is different from the traditional combination of a mirror and a sheath. After the channel core 2 is pulled out, it can be used as a working channel. It has a simple structure and is convenient for connecting to the outside. When an external negative pressure suction device is connected, the suction effect is better because there are no corners; the power capsule P passes through the operating handle from the outer opening 151 of the internal channel 150 of the operating handle, which has a connection effect equivalent to the outer opening 112 of the main channel extending to the outer opening 151 of the internal channel 150 of the operating handle.

[0062] During use, the channel core 2 is first placed into the main channel 11, and the channel core head 21 is protruded from the opening 111 in the main channel. The channel core 2 and the endoscope body 1 are fixed relative to each other by manual manipulation or using a locking mechanism (not shown). The power interface 151 is plugged into the external power data cable. During the visualization process, after the channel core 2 is advanced to the target position of a natural cavity such as the urinary tract, the fixed relationship between the channel core 2 and the endoscope body 1 is released, and the channel core 2 is pulled out from the main channel 11.

[0063] When the endoscope body 1 moves forward, the power capsule P is pressed to squeeze the fluid in the power capsule inner cavity P0 into the capsule inner cavity C0, which can expand the capsule C. In order to make the channel core head 21 form a cone to reduce the resistance when moving forward in the natural cavity, the capsule C can first be expanded in the first stage. The first stage expansion refers to expanding the capsule C into a cone, and setting expansion constraint ribs or a capsule wall design with thick top and thin bottom in the capsule to make the head of the capsule C pointed and the outer edge C111 of the bottom end of the capsule C flush with or slightly larger than the outer edge 121 of the top end of the endoscope body head. When encountering resistance when moving forward, the second stage expansion with a greater degree is activated to expand the body tissue in the narrow part. The first stage expansion of the capsule C can be maintained at the same level by a locking structure (not shown) that prevents the elastic recovery of the power capsule P.

[0064] Another solution based on the same idea is that the channel core head 21 is a soft cone when the capsule C has not yet expanded. This solution increases the wall thickness of the capsule C and thus increases the resistance of the channel core 2 to being pulled out of the main channel 11.

[0065] As shown in FIG1D , in actual use, when the insertion into the natural cavity encounters resistance, in this embodiment, the conical tip of the channel core head 21 is inserted into the stenosis N of the ureter U and cannot move forward, and the power balloon P can be pressed in vitro, and fluid can be filled into the balloon C, which can be gas in the inner cavity P0 of the power balloon or liquid, to expand the balloon C. As shown in FIG1E , the balloon C in the radially expanded state can fully and safely expand the stenosis N of the natural cavity. After the expansion lasts for several seconds or minutes, the power balloon P in vitro is quickly released, and the expanded balloon C quickly returns to its original state, while the expanded ureter U will not recover quickly. At this time, the endoscope can be pushed forward to pass through the previous stenosis N smoothly.

[0066] The outer diameter of the expanded balloon C is preferably at least larger than the outer diameter of the head of the endoscope body 1, which is beneficial for the endoscope body 1 to continue to move forward in the ureter U. When the head 12 of the endoscope body 1 reaches the predetermined position, as shown in Figure 1F, the relative position of the endoscope body 1 and the ureter U remains unchanged, and force is applied from outside the body to retract the head 21 of the channel core into the main channel 11, and finally the channel core 2 is pulled out as a whole, and the main channel 11 is vacated. The outer opening 151 of the internal channel 150 of the operating handle connected to the outer opening 112 of the main channel can be blocked or opened according to operational needs, or an external negative pressure suction line can be connected.

[0067] The main channel 11 is used for the passage of medical tools when in use, and provides guidance, protection and other corresponding functions for the medical tools located therein, such as various catheters, guide wires, stone baskets, optical fibers, ultrasonic catheters, etc. During laser lithotripsy operations such as holmium laser and thulium laser, the negative pressure suction side branch 10f of the main channel is connected to a negative pressure device (not shown) to continuously attract and transport the fragments out of the body. In this example, the laser optical fiber (not shown) can enter the main channel 11 from the hollow optical fiber side branch 10g extending from the tail 14 of the endoscope body, or it can enter from a separate optical fiber channel set up in the endoscope body (not shown); the perfusion side branch 10e can be injected with physiological saline to cool and flush during the lithotripsy process; and a secondary channel can also be set outside the main channel 11 according to clinical needs for the passage of the above-mentioned medical tools.

[0068] The medical endoscope of the present invention combines the functions of traditional hard endoscopes and soft endoscopes; and combines the functions of traditional guide sheaths or channel sheaths and soft endoscopes; thereby significantly enlarging the inner diameter of the working channel, i.e., the main channel 11, on the endoscope body 1. When the endoscope body is 12Fr, the inner diameter of the main channel 11 can be released to between 1.2mm and 2.8mm, which is much larger than the working channel size of the soft endoscope under the same guide sheath; and when the endoscope body is made into 10Fr or 8Fr, its working channel is larger than the working channel size of the traditional endoscope used in the guide sheath of the same specification.

[0069] The traditional transurethral laser lithotripsy operation usually involves placing a flexible endoscope into the lumen of the ureteral guide sheath. The outflow path for small fragments after the stones are broken is usually the gap between the flexible endoscope and the ureteral guide sheath. Due to the narrow working channel, larger stones need to be removed from the body through the flexible endoscope under the sheath of the stone basket and then cleaned. If the water flow is not smooth or the gap is blocked, the endoscope needs to be withdrawn in time. There are usually dozens or hundreds of endoscope withdrawal operations in one operation, which is cumbersome and time-consuming. Even with the protection of the ureteral guide sheath, the repeated advancement and withdrawal of the flexible endoscope will cause the ureteral guide sheath to swing, thereby damaging the urinary tract. In the lithotripsy operation of the present invention, the stone fragments are discharged through the spacious main channel, and there is no need to withdraw the endoscope. Laser lithotripsy can generally crush the stones to less than 2 mm, and the main channel diameter can be greater than 2 mm. If laser equipment is used to crush the stones to a smaller degree, the size of the main channel can be reduced simultaneously.

[0070] When used in the treatment of urinary stones, lithotripsy is performed under pressure and temperature monitoring, which increases the safety factor. In order to reduce the resistance of the endoscope during advancement, at least the channel core head 21 and / or the outer surface of the endoscope body 1 are provided with a hydrophilic coating (not shown), and the hydrophilic coating can be applied to the outside of the capsule C. To facilitate optical observation of the endoscope, at least the channel core head 21 is made of a transparent or translucent material. Due to the expansion and advancement function of the channel core head capsule C under visual guidance, many operations do not require the insertion of a guide wire first, which reduces the patient's pain and shortens the operation time.

[0071] If the soft endoscope is difficult to advance during the insertion process and the strength of the traditional hard endoscope is needed, the channel core 2 with at least a hard head can be placed in the main channel 11 of the endoscope. When combined with the endoscope body 1 which is itself a soft endoscope, the strength of the soft endoscope can be significantly improved to achieve the effect of a hard endoscope or a near-hard endoscope. The slender channel core 2 body part, such as the channel core head 21 or the channel core head 21 together with a part of the channel core middle part 22, can be made of hard materials such as metals such as nickel-titanium alloy or high-strength polymer materials such as polyetheretherketone. Alternatively, the part of the channel core 2 body located in the main channel 11 of the endoscope when in use can be made hard. The strategy of uneven hardness of the channel core 2 body can be used to meet different clinical needs. When the endoscope body head 12 reaches the target position during use, By pulling out the at least partially hard channel core 2, the endoscope body 1 will restore its soft mirror properties, and subsequent operations will significantly reduce tissue damage; of course, in addition to changing the hardness of the channel core 2 material, setting a slender inner cavity in the channel core 2 and inserting a rigid guide wire into the hollow channel core 2 during use can also make the entire endoscope approach or reach the strength of a hard mirror.

[0072] Example 2:

[0073] As shown in Figures 2A-2G, in this example, the channel core 2 is hollow inside and connected from head to tail, and the inner cavity 20 of the channel core can allow a slender guide wire G to pass through (Figure 2B); as shown in Figure 2A, the outer side of the channel core head 21 is covered with two expandable capsules C, namely the inner capsule C1 and the outer capsule C2, and the wall of the channel core 2 is provided with an inner capsule passage C100 and an outer capsule passage C200 connected to the outside, the inner capsule cavity C10 is connected to the inner capsule passage C100 through the inner opening C101 of the inner capsule passage; the outer capsule cavity C20 is connected to the outer capsule passage through the inner opening C101 of the outer capsule passage. The opening C201 is connected to the outer balloon passage C200; the outer balloon C2 completely covers the inner balloon C1; as shown in Figure 2C, when the inner balloon C1 is in the first stage of expansion, the channel core head 21 is shaped into a cone, and it encounters resistance when advancing along the guide wire G in the ureter U. As shown in Figure 2D, the outer balloon C2 is inflated to expand the ureter U and then continues to ascend along the guide wire G until it reaches the target position. The double-balloon setting allows the inner balloon C1 to be used to shape the flexible cone shape of the channel core head 21, while the outer balloon C2 is used for safe radial expansion of the narrow area.

[0074] As a variation of this example, the outer capsule C2 and the inner capsule C1 can also be designed to be separated up and down (not shown). The shaping is slightly worse, but the outer diameter of the channel core head 21 can be minimized, making it easier to pull the channel core 2 out of the main channel 11.

[0075] As shown in FIG2E , as another variation of this example, the outer balloon C2 only covers the upper part C11 of the inner balloon C1, while the lower area C12 of the inner balloon is directly exposed to the outside. When in use, the inner balloon C1 is first filled to make the outer shape conical, which is easy to advance in the natural cavity. A one-way air valve similar to the inflation and deflation of the endotracheal tube airbag (not shown) can be used to pre-fill the balloon C1 before use. The external connecting pipeline connected to the inner balloon passage C100 can also be temporarily clamped. When resistance is encountered, the outer balloon C2 is further filled to expand the narrow area. As shown in FIG2F , the inner balloon C1 can also be further filled while the outer balloon C2 is filled. The pressure of the upper part C11 of the inner balloon embedded in the outer balloon C2 can be transmitted to the outer balloon C2 to start The outer capsule C2 can adjust the pressure inside the outer capsule C2 and change the external shape of the outer capsule C2 after expansion, so that the expansion of the stenosis has a variety of strength and structural adjustment methods, which makes it easier to achieve a good expansion effect; this design can also make it easy to pull the channel core 2 out of the main channel 11 after the inner capsule C1 and the outer capsule C2 are released from filling; the outer capsule C2 covers the upper part C11 of the inner capsule, and the lower area C12 of the inner capsule is directly exposed to the outside, that is, when in use, the lower area C12 of the inner capsule can contact the biological tissue, and can also play a role in radial expansion of the stenosis; the outer capsule C2 is preferably a compliant capsule, which can fully and evenly expand the tissue at the stenosis without easily causing tissue tearing and damage, and the inner capsule C1 can be compliant or non-compliant.

[0076] As shown in FIG2G , the endoscope body 1 has an annular protrusion 16 connected to its head. The protrusion 16 is preferably made of a thin-walled flexible material and can be a separate component connected to the endoscope body 1 or an extension of the outer layer of the tubular endoscope body 1. The portion that blocks the field of view of the lens 10a can be made of a transparent material. As shown in FIG2A , the channel core head 21 can protrude from the upper opening 160 of the annular protrusion 16. The lower edge of the outer capsule C2 is higher than or at least flush with the upper opening 160 of the annular protrusion 16 to prevent obstruction during the filling and expansion of the outer capsule C2. The material of the annular protrusion 16 does not affect the conduction of light; during laser lithotripsy, stones are prevented from damaging the lens 10a, and the stones can also be adsorbed on the upper opening 160 of the annular protrusion 16 while maintaining a stable distance from the lens 10a to release laser energy; a notch 161 is provided on the upper edge of the annular protrusion 16, and the notches 161 of the annular protrusion 16 can be arranged in a wave shape singly or in multiples. During operation, water can be discharged or returned from the notch 161 of the annular protrusion. After the water is discharged, it can not only reduce the high temperature of the local area of ​​laser treatment, but also drive the fine gravel through the notch 161 of the annular protrusion 16 into the main channel 11, and thus be sucked out of the body by negative pressure.

[0077] The guide wire G in this example is used for forward guidance in complex urinary tract conditions and for placement of ureteral stents after surgery; the height of the annular protrusion 16 is preferably within 20 mm, and actual measurements show that it is usually 2 mm to 6 mm, which does not affect the observation and bending functions of the lens 10a. The upper edge of the annular protrusion 16 can be moderately retracted or everted.

[0078] Example 3:

[0079] As shown in Figure 3A, the outer side of the channel core head 21 is covered with an expandable eccentric capsule that is asymmetrically distributed along the axial direction. This figure shows that the outer capsule C2 is an eccentric capsule, while the inner capsule C1 is non-eccentric. The eccentric outer capsule C2 can expand asymmetrically on the left and right to adapt to the inherent asymmetric characteristics of the natural cavity.

[0080] As shown in FIG3B , another eccentric sac configuration is that the outer sac C2 is not eccentric but the inner sac C1 is eccentric. When the eccentric inner sac C1 undergoes secondary expansion, it drives the outer sac C2 to also undergo eccentric deformation.

[0081] When the main channel 11 is designed to be eccentric and not centered on the endoscope body 1, even if an eccentric single capsule is selected, when partially filled, the outer contour of the eccentric capsule is conical and protrudes from the opening 111 in the main channel. When the eccentric capsule is partially filled, it can compensate for the geometric deviation caused by the non-centering of the main channel 11, and ensure the mechanical stability of the endoscope body when it moves forward; and when encountering a stenosis and the resistance to advancement increases, the stenosis can be expanded by further filling the eccentric capsule.

[0082] Example 4:

[0083] As shown in Figures 4A and 4B, for better operation, a component that can actively bend the endoscope body head 12 is provided in the endoscope body 1. In order to eliminate the visual blind spot, the endoscope body head 12 is bent at least more than 200°, preferably to about 300°. A knob 152 for adjusting the degree of bending is provided on the operating handle 15. The bending structure can be achieved by traditional methods such as connecting multiple snake-bone components in series and controlling the traction line (Figure omitted).

[0084] As shown in Figure 4A, this example shows the first power bag P1 and the second power bag P2 extending out of the operating handle 15, which can respectively drive the inner bag body C1 and the outer bag body C2 in Example 2, Example 3, and Example 4. The first power bag inner cavity P10 and the second power bag inner cavity P20 are connected to the inner bag inner cavity C10 and the outer bag inner cavity C20 through the first inner cavity opening P11 and the second inner cavity opening P21 via the inner bag passage C100 and the outer bag passage C200.

[0085] The curved structure of the endoscope head 12 will cause local thickening. For example, when the cross-sectional circumference of the middle part 13 of the endoscope body is 12Fr, the curved part of the endoscope head 12 may be close to 14Fr. Although it is locally thickened, it is mainly operated in the spacious part of the renal pelvis and will not have too many disadvantages. If a circular shape is used, the inner diameter of the main channel 11 can be released to between 1.2mm and 2.8mm, which is much larger than the working channel size of the soft endoscope under the same guide sheath.

[0086] According to the above description and embodiments of the medical endoscope of the present invention, when passing through a narrow part of a natural cavity, the head capsule of the channel core expands radially, eliminating the local narrowing, and then the head capsule recovers, allowing the soft lens head to move forward smoothly, eliminating the shear damage to the tissue when the axial advancement of the traditional hard endoscope encounters resistance, and replacing the function of the hard endoscope.

[0087] Compared with the traditional soft endoscope used in the guide sheath, the gap between the soft endoscope and the guide sheath is eliminated, and the soft endoscope and the guide sheath are integrated into one, thereby expanding the working channel of the soft endoscope and eliminating the tedious operation of multiple withdrawal of the endoscope, improving efficiency and reducing tissue damage; because the head capsule of the channel core can expand and move forward under visual guidance, many operations do not require the insertion of a guide wire first, reducing patient pain and shortening operation time; the internal channel of the operating handle is connected to the main channel of the endoscope. This axial connection method is different from the traditional combination of endoscope and sheath. After the channel core is pulled out, the main channel of the endoscope can be used as a working channel. It has a simple structure and is convenient for connecting to the external pipeline. When an external negative pressure suction device is connected, the suction effect is better because there are no corners.

[0088] The channel core head has a double-bladder design. While the inner bladder maintains a conical shape, the outer bladder expands conformably to the natural stenosis of the cavity, ensuring smooth progress while protecting living tissues from shear damage to the soft lens head structure to the greatest extent.

[0089] The integration of hard endoscope, soft endoscope and guide sheath into one will further reduce product costs when produced in large quantities.

[0090] When the present invention is used in urinary tract surgery, such as transurethral laser lithotripsy, the head capsule can radially expand the urethral membranous part during insertion to protect the external sphincter; the head capsule can radially expand the tissue at the connection between the ureter and the bladder to protect the Waldeyer sheath; when the ureter is locally narrowed, the radial expansion makes it easier to pass through, eliminating the axial shear damage at the local narrowing of the ureter caused by traditional passage methods.

[0091] Lithotripsy, stone removal, flushing and other operations can be performed under real-time monitoring of pressure and temperature, which significantly improves the safety factor; the endoscope head is actively bent, and there is no blind spot in observing the renal calyx, which can completely crush the stones.

[0092] The annular protrusion protruding from the head of the endoscope can combine with the negative pressure in the main channel to suck the stones into the opening of the annular protrusion without blocking the lens, thereby safely and accurately crushing the stones. The notch on the upper edge of the annular protrusion is a water flow channel, which can be injected with water for cooling to avoid thermal damage to the tissue during laser release.

[0093] The liquid outlet on the head of the endoscope sprays sterile flushing fluid to flush the gravel into the spacious main channel. The main channel is externally connected to a negative pressure suction device, which makes it easy to completely remove the stones during the operation. Compared with the traditional postoperative procedure in which patients need to urinate for many days to excrete all the gravel, the treatment effect is significantly improved.

[0094] If the insertion process requires the strength of a traditional hard endoscope, at least the hard channel core at the head can significantly improve the strength of the soft endoscope when combined with the endoscope body, reaching the level of a hard endoscope or close to that of a hard endoscope to meet clinical needs.

[0095] The medical endoscope of the present invention significantly simplifies the operating steps, reduces tissue damage, greatly saves surgical time and reduces treatment costs; it can be used for medical operations in various natural cavities including the cardiovascular tract, respiratory tract, tear duct, ear canal, reproductive tract, and digestive tract, or in the third space of a living body such as the chest cavity and abdominal cavity, and can also be used for medical operations on penetrating wounds, pathological sinuses, etc.

Claims

1. A medical endoscope, wherein the endoscope body (1) is provided with an optical component, the endoscope body (1) is further provided with a main channel (11) running through the head and tail, the main channel (11) is provided with a main channel inner opening (111) entering the body in the use state and a main channel outer opening (112) located outside the body in the use state, a channel core (2) is provided in the main channel (11), and the characteristics are: The channel core head (21) protrudes from the opening (111) in the main channel. The outer side of the channel core head (21) is covered with an expandable sac (C). The maximum outer diameter of the expanded sac (C) is greater than or equal to the outer diameter of the head of the endoscope body (1). The inner cavity (C0) of the sac is connected to the outside through a sac passage (C00) opened on the channel core (2). When the endoscope is placed in a living body cavity and encounters resistance, fluid can be filled into the sac (C) from outside the body to expand it, radially expanding the narrow part of the living body cavity, so as to facilitate the endoscope body (1) to continue to move forward in the living body cavity.

2. A medical endoscope according to claim 1, characterized in that: The outer side of the channel core head (21) is covered with an expandable bladder (C) with a conical outer contour, so that the channel core head (21) protrudes from the inner opening (111) of the main channel in a conical shape.

3. A medical endoscope according to claim 1, characterized in that: The channel core (2) is hollow inside and connected from head to tail, and the inner cavity (20) of the channel core allows the guide wire (G) to pass through.

4. A medical endoscope according to claim 1, characterized in that: The outer side of the channel core head (21) is covered with two expandable capsules (C), namely an inner capsule (C1) and an outer capsule (C2); the inner capsule (C1) and the outer capsule (C2) are respectively provided with an inner capsule passage (C100) and an outer capsule passage (C200) connected to the outside; the outer capsule (C2) at least partially covers the inner capsule (C1).

5. A medical endoscope according to claim 4, characterized in that: The outer capsule (C2) covers the upper part of the inner capsule (C1), and the lower area of ​​the inner capsule (C1) is directly exposed to the outside, that is, when in use, the lower area of ​​the inner capsule (C1) can contact biological tissue.

6. A medical endoscope according to claim 1, characterized in that: The outer side of the channel core head (21) is covered with an expandable eccentric sac that is asymmetrically distributed along the axial direction. When partially filled, the outer contour of the eccentric sac is conical and protrudes from the inner opening (111) of the main channel.

7. A medical endoscope according to claim 1, characterized in that: The head of the endoscope body (1) is connected to an annular protrusion (16), and the channel core head (21) can be protruded from the upper opening (160) of the annular protrusion (16).

8. A medical endoscope according to claim 7, characterized in that: At least one notch (161) is provided on the upper edge of the annular protrusion (16).

9. A medical endoscope according to any one of claims 1 to 8, characterized in that: At least the channel core head (21) and / or the outer surface of the endoscope body (1) is coated with a hydrophilic coating.

10. A medical endoscope according to any one of claims 1 to 8, characterized in that: The inner diameter of the main channel (11) on the endoscope body (1) is between 1.2 mm and 2.8 mm.

11. A medical endoscope according to any one of claims 1 to 8, characterized in that: At least the channel core head (21) is in a transparent or translucent state.

12. A medical endoscope according to any one of claims 1 to 8, characterized in that: At least a portion of the elongated channel core (2) is made of hard material, and after being inserted into the main channel (11) of the endoscope, it can increase at least the local strength of the endoscope, making at least the local strength of the endoscope close to or equivalent to that of a hard endoscope.

13. A medical endoscope according to any one of claims 1 to 8, characterized in that: The rear end of the endoscope body (1) is connected to an operating handle (15), and an internal channel (150) of the operating handle is connected to the main channel (11).

14. A medical endoscope according to any one of claims 1 to 8, characterized in that: A component capable of actively or passively bending the endoscope body head (12) is provided inside the endoscope body (1).

15. A medical endoscope according to any one of claims 1 to 8, characterized in that: The endoscope main body head (12) is provided with a pressure sensor and / or a temperature sensor (10d).

16. A medical endoscope according to any one of claims 1 to 8, characterized in that: The tail of the main channel (11) is connected to at least one side branch passage, and the side branch passage is provided with a side branch opening.

Citation Information

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