Protective medical endoscope device and transureteral lithotripsy surgical system

Abstract

The present invention provides a protective medical endoscope device and a transureteral lithotripsy surgical system, which relate to the field of medical devices. The head of the endoscope main body is provided with an inflatable sac structure, the head is protected by an integrated endoscope sheath, and the endoscope sheath is inserted synchronously in an integrated manner. The flexible sac shielding structure prevents the hard edge of the sheath main body head from contacting the tender mucous membrane of the natural cavity throughout the entire process. When the device encounters resistance when advancing in the natural cavity, fluid is filled into the inner cavity of the sac from outside the body to expand the natural cavity and flexibly expand the natural cavity. The filling is released to restore the sac. At this time, the expanded natural cavity has not yet returned to its original state. Continuing to advance will minimize the resistance. The value of the present invention is particularly prominent when encountering stenosis of the natural cavity. The present invention eliminates cumbersome steps while fully ensuring the safety of the patient's natural cavity, thereby improving operating efficiency.

Description

Technical Field

[0001] The present invention relates to a protective medical endoscope device and a transureteral lithotripsy operation system, 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 strong but easy to enter natural cavities or pathological sinuses of living organisms. Although soft endoscopes have the defect of being difficult to insert, they are slender and soft, allowing them to contact natural cavities for a longer time during operation and causing less damage than hard endoscopes. For example, transurethral laser kidney stone surgery usually involves 1. inserting a hard endoscope into the bladder and ureter through the urethra; 2. then inserting a guide wire into the renal pelvis through the working channel of the hard endoscope; 3. withdrawing the hard endoscope, leaving only the guide wire in the urinary tract; 4. then inserting a ureteral sheath and a sheath core located inside the sheath through the guide wire; 5. . Pull out the sheath core from the ureteral sheath; 6. Then insert the soft endoscope from the ureteral sheath, and the working channel opening at the head of the soft endoscope undertakes the functions of optical fiber lithotripsy, cooling and flushing, and stone extraction; inserting the soft endoscope requires multiple steps and the operation is cumbersome; and regardless of hard endoscopes or soft endoscopes, when advancing in the natural cavity of a living body, the hard edge of the head of the endoscope component is in continuous dynamic contact with the natural cavity mucosa, and shear damage is difficult to avoid. When encountering a narrow part of the natural cavity, this shear damage is more serious and may even cause perforation; the safety protection measures for the endoscope placement process in the existing technology are weak or even non-existent, and the shear damage to the natural cavity mucosa is prone to secondary infection and functional disorders. Summary of the Invention

[0003] The present invention provides a protective medical endoscope device and a transureteral lithotripsy surgical system. The head of the endoscope main body is provided with an inflatable sac structure, the head is protected by an integrated endoscope sheath, and the endoscope sheath is inserted synchronously in an integrated manner. The flexible sac shielding structure prevents the hard edge of the sheath main body head from contacting the tender mucous membrane of the natural cavity throughout the entire process. When the device encounters resistance when advancing in the natural cavity, fluid is filled into the inner cavity of the sac from outside the body to expand the natural cavity and flexibly expand the natural cavity. The filling is released to restore the sac. At this time, the expanded natural cavity has not yet returned to its original state. Continuing to advance will minimize the resistance. The value of the present invention is particularly prominent when encountering stenosis of the natural cavity. The present invention eliminates cumbersome steps while fully ensuring the safety of the patient's natural cavity, thereby improving operating efficiency.

[0004] The object of the present invention is achieved like this:

[0005] A protective medical endoscope device, wherein an optical component is provided on a slender endoscope body, the endoscope body is provided with a working channel running through the head and tail, the working channel is provided with an inner working channel opening which enters the body when in use and an outer working channel opening which is located outside the body when in use; a sheath, a slender sheath body is sleeved on the outside of the endoscope body, the sheath body is provided with an inner sheath body opening which enters the body when in use and an outer sheath body opening which is located outside the body when in use, the top end of the endoscope body head is covered with an expandable capsule, the capsule is composed of a capsule connecting part and a capsule free part, the capsule connecting part is cylindrical and connected to the outer surface of the endoscope body head, the capsule free part is the expandable part of the capsule, and the gap between the capsule free part and the top end of the endoscope body head forms the capsule inner cavity; the maximum outer diameter of the expanded capsule free part is at least larger than the outer diameter of the endoscope body head diameter; the free part of the capsule is transparent or at least the area corresponding to the optical component at the top of the endoscope main body head is transparent; the inner cavity of the capsule is connected to the working channel; a fastening mechanism that can be tightly connected to the tail of the endoscope is provided at the outer opening of the sheath main body. When in use, the top of the endoscope main body head is protruded from the inner opening of the sheath main body, at least a part of the free part of the capsule at the top of the head is exposed to the outside, and the fastening mechanism is activated to tightly connect the sheath main body with the endoscope main body, so as to realize the synchronous advance and retreat of the endoscope and the sheath; when the endoscope main body encounters resistance when moving forward in the natural cavity of a living body, fluid can be filled into the inner cavity of the capsule through the outer opening of the working channel to make it expand, and radially flexibly expand the tissue at the narrow part of the natural cavity, so as to facilitate the endoscope main body to continue to move forward in the natural cavity; after the device reaches the target position, the fastening mechanism is loosened, and the endoscope main body can freely rotate or move back and forth in the sheath main body.

[0006] The sac is preferably made of a compliant material and can extend forward while radially expanding the natural cavity; the sac connection portion is cylindrical and is connected to the outer surface of the endoscope body head in an easily separable connection so as to expose the working channel of the endoscope body for subsequent other medical operations; the outer opening area adjacent to the sheath body is provided with a fastening mechanism that can be tightly connected to the tail of the endoscope, and the fastening mechanism can be set at the tail of the sheath body or at the tail of the endoscope body, preferably at the tail of the sheath body; the protective medical endoscope device in the present invention covers a flexible endoscope body and a hard endoscope body, and covers an electronic endoscope and an optical endoscope.

[0007] In order to meet some clinical needs, the area on the free part of the capsule corresponding to the working channel is a fragile area that is easily punctured by the guide wire, and one or more fragile structures are provided on the fragile area.

[0008] When there is only one vulnerable structure, the guide wire can be accurately positioned when the balloon is not inflated; when there are multiple vulnerable structures, the guide wire can easily contact a certain vulnerable structure even when the balloon is inflated.

[0009] The free part of the capsule is provided with a guide wire hole for the guide wire to pass through; the guide wire hole is in contact with the guide wire without a gap; a reinforcement structure is provided around the guide wire hole, including at least one of a reinforcement rib, an upper extension section, and a lower extension section.

[0010] When an endoscope is used with a sheath to advance under the guidance of a guidewire, or when a balloon is used to expand a natural cavity and then advance under the guidance of a guidewire; the guidewire hole and the guidewire inserted therein are in gapless contact, preferably interference contact. In order to ensure that the fluid in the inner cavity of the balloon will not leak from the gap that may appear between the guidewire and the guidewire hole when the free part of the balloon expands, a reinforcement structure is provided around the guidewire hole on the free part of the balloon, including an annular reinforcement rib that bulges around the guidewire hole, and a hollow upper extension section and a lower extension section that are integrated with the guidewire hole; when the reinforcement structure is an upper extension section and a lower extension section, the guidewire passes through the extension section, the contact area is larger, and it is less likely to leak fluid when the free part of the balloon expands. Even if partial fluid leakage occurs during specific use, it will not seriously affect the effect of balloon expansion and expansion of the natural cavity.

[0011] A refined design is that, in order to increase the volume after expansion, the free part of the capsule is provided with a protrusion extending toward the distal end in a nipple-like manner; or, the free part of the capsule is provided with one or more annular folds.

[0012] The hollow protrusion and the annular wrinkle structure significantly increase the surface area of ​​the free part of the capsule while keeping the projection area of ​​the top of the endoscope main body head unchanged, thereby increasing the volume of the capsule lumen after expansion, which is beneficial for axial extension and expansion along the natural cavity when filled, and expanding more narrow cavities; if the protrusion is designed to be non-hollow, the non-hollow solid protrusion can easily move forward along the narrow natural cavity, and play a certain guiding role in the subsequent capsule expansion.

[0013] In order to ensure that there is no fluid leakage when the balloon is filled and expanded, the balloon connecting part is sealed and connected to the outer surface of the endoscope main head. In order to increase the friction between the two, the balloon connecting part and the outer surface of the endoscope main head are preferably interference fit. This interference fit can be detached when the free part of the balloon is pulled by a greater external force. In order to increase the stability of the connection and to make the free part of the balloon easier to expand, preferably, the wall thickness of the balloon connecting part is greater than that of the free part of the balloon.

[0014] A key safety design is that a flexible capsule shielding portion extends outward from the junction of the capsule free portion and the capsule connecting portion.

[0015] Furthermore, a flexible capsule shielding portion that can cover the outer edge of the inner opening of the sheath body extends outward from the junction of the capsule free portion and the capsule connecting portion. The flexible capsule shielding portion is provided with a cylindrical flange that covers the outer edge of the inner opening of the sheath body.

[0016] The outer edge of the inner opening of the thin-walled sheath body is relatively sharp, which can easily shear and damage the natural cavity lining it contacts when moving forward. The flexible capsule shielding part covers the outer edge of the inner opening of the sheath body, eliminating the above-mentioned risk of shear damage. Combined with the characteristics of the expansion-type forward movement of the free part of the capsule, it has a double protection effect.

[0017] One solution for manually filling the sac is that the outer opening of the working channel is connected to a hollow elastic power sac. Squeezing the elastic power sac can fill the fluid inside the sac into the inner cavity of the sac, causing the free part of the sac to expand; after the squeezing is released, the fluid in the inner cavity of the sac flows back to the inner cavity of the elastic power sac, and the shape of the free part of the sac returns to the shape before expansion.

[0018] The elastic power sac can be squeezed or relaxed repeatedly with the fingers, and the sac body will be filled, expanded or restored synchronously, making full use of the elastic power sac's own restoration ability and being easy to use. The elastic power sac is connected to the outer opening of the working channel through an extension section. A connecting hole can be provided on the elastic power sac. When squeezing, the finger presses and closes the connecting hole, and the gas in the elastic power sac is filled into the inner cavity of the sac. After the free part of the sac expands for a certain period of time, the finger is released, and the elastic power sac's own rebound plus the gas flows out of the connecting hole, so that the free part of the sac recovers faster. An external syringe or other electronically controlled perfusion device and negative pressure suction device can also be connected.

[0019] For flexible operation, a section of the sheath body adjacent to the inner opening of the sheath body is a bendable section of the sheath body, and / or a section of the endoscope body adjacent to the inner opening of the working channel is a bendable section of the endoscope.

[0020] The flexible section makes it less likely for the endoscope to have blind spots in vision and operation in the renal pelvis and calyx.

[0021] A transureteral lithotripsy surgical system further includes at least one of an irrigation device, a lithotripsy optical fiber, a negative pressure suction device, a pressure sensor, a temperature sensor, a stone basket, and a guide wire.

[0022] The pressure sensor and temperature sensor can be set in the area near the opening inside the sheath body, or in the head of the endoscope, to facilitate the monitoring of pressure and temperature in the urinary tract during surgery and ensure the safety of the surgery; in order to reduce friction during insertion and operation, at least one of the free part of the capsule, the endoscope body, the sheath body, and the guide wire is provided with a hydrophilic coating.

[0023] The beneficial effects of the present invention are:

[0024] 1. During the natural cavity advancement process of this device, the hard head edge of the sheath body is protected by the flexible capsule shielding part throughout the entire process, significantly reducing the mucosal shear damage during the endoscope placement process.

[0025] 2. When encountering natural cavity stenosis during the endoscope placement process, the capsule at the head of the endoscope body is inflated and expanded, and after radial expansion of the tissue at the stenosis, the capsule is released to facilitate subsequent passage.

[0026] 3. The endoscope and sheath are advanced synchronously, which reduces the operation steps and improves efficiency.

[0027] 4. The expansion of the head capsule based on visualization can eliminate the need for a guide wire during the endoscopic procedure.

[0028] 5. The head bladder expands under pressure monitoring to expand the natural cavity, and the expansion effect is more reliable.

[0029] 6. When inserted into the urethra, the capsule at the head of the endoscope body can slowly expand the urethral membranous part radially, protect the external urethral sphincter, and avoid postoperative urinary control difficulties to the greatest extent.

[0030] 7. Flexibly dilate the junction of the ureter and bladder, protect the Waldeyer sheath, and minimize the occurrence of postoperative vesicoureteral reflux.

[0031] It significantly simplifies the operation steps, reduces tissue damage, greatly saves operation time and reduces treatment costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The accompanying drawings which do not limit the present invention are as follows:

[0033] Figure 1A : Schematic diagram of the use of sheath tube, sheath core and guide wire in the prior art;

[0034] 1A-1: The sheath, sheath core, and guidewire are combined; 1A-2: A rigid endoscope is inserted into the renal pelvis P while the guidewire G is inserted; 1A-3: The sheath core is inserted into the sheath body and ascends along the guidewire G;

[0035] Figure 1B : Schematic diagram of the prior art endoscope main body entering the sheath main body;

[0036] Among them, 1B-1: the endoscope body enters the sheath body, and the bendable head portion of the endoscope body protrudes from the opening in the sheath body; 1B-2: the head portion of the sheath body is located near the junction of the ureter U and the renal pelvis P; 1B-3: the bendable head portion of the endoscope body protrudes from the opening in the sheath body and extends into the renal pelvis P;

[0037] Figure 1C : Schematic diagram of an endoscope in Example 1, wherein the head of the endoscope body is covered with an expandable bladder;

[0038] Figure 1D : Schematic diagram of the sheath tube of Example 1, showing the fastening mechanism T at the tail of the sheath tube body in cross section;

[0039] Figure 1E: Schematic diagram of the combination of an endoscope and a sheath tube in Example 1, with a partial cutaway showing the elastic power bladder connected to the bladder body at the head of the endoscope body, and the fastening mechanism T at the tail of the sheath tube body connected to the endoscope handle;

[0040] Figure 1F : Schematic diagram of the two embracing arms T1 and the fastening knob T2 of the sheath body tail fastening mechanism T of Example 1 in the separated state, with the endoscope body tail 14 placed therein;

[0041] Figure 1G : A cross-sectional view of a type of capsule free portion 22 covering the head of an endoscope body in an unexpanded state in Example 1, wherein the capsule free portion is provided with a hollow protrusion extending toward the distal end in a papillary shape;

[0042] Figure 1H : A cross-sectional view of another embodiment of the capsule free portion 22 having an annular wrinkle structure;

[0043] Figure 1I : A cross-sectional view of another solid protrusion extending toward the distal end in a papillary shape from the free portion 22 of the capsule in Example 1;

[0044] Figure 1J : A schematic cross-sectional view of the capsule shielding portion 23 of Example 1;

[0045] Figure 1K : Schematic cross-sectional view of the cylindrical flange 232 of the capsule shielding portion 23 of Example 1;

[0046] Figure 1L : A schematic cross-sectional view of the free portion 22 of the capsule at the narrowed portion N of the ureter U according to Example 1;

[0047] Figure 1M : A cross-sectional view of the expanded state of the free portion 22 of the balloon in Example 1, wherein the narrow portion N of the ureter U is radially expanded;

[0048] Figure 1N : Example 1: The endoscope and sheath are advanced in an integrated manner. The partial cross-section shows that the sheath main body head is located at the junction of the ureter U and the renal pelvis P, and the embracing arm T1 and the fastening knob T2 are separated;

[0049] Figure 1O : Example 1 The endoscope body is withdrawn from the inner cavity 31 of the sheath body to the outside of the body, and the partial cross-section shows the reverse deformation state of the shielding portion 23 of the free portion of the capsule;

[0050] Figure 2A : A cross-sectional view of a vulnerable region 220 of the free portion 22 of the capsule that is easily punctured by the guidewire G and a vulnerable structure 221 on the vulnerable region in Example 2;

[0051] Figure 2B : A three-dimensional schematic diagram of Example 2;

[0052] Figure 2C : A three-dimensional schematic diagram of the guidewire G of Example 2 puncturing the fragile structure 221;

[0053] Figure 3A : Partial cross-sectional view of the guide wire hole 222 and the surrounding reinforcing ribs 223 on the free portion 22 of the capsule in Example 3;

[0054] Figure 3B : A partial cross-sectional view of Example 3 showing a guide wire G inserted into the guide wire hole 222 on the free portion 22 of the capsule and the free portion 22 of the capsule in an expanded state;

[0055] Figure 3C : A cross-sectional view of a modified structure of Example 3, in which an upper extension section 224 is provided around the guide wire hole 222;

[0056] Figure 3D : A cross-sectional view of a modified structure of Example 3, in which the upper extension section 224 moves forward as the free portion 22 of the capsule expands;

[0057] Figure 3E : Another alternative structure of Example 3, a partial cross-section shows that a lower extension section 225 is provided around the guide wire hole 222 of the free part 22 of the capsule and the capsule shielding part 23 has a cylindrical flange 232. DETAILED DESCRIPTION

[0058] The embodiments of the present invention are not limited to the following:

[0059] Example 1:

[0060] like Figure 1C As shown, a protective medical endoscope device, a flexible and slender endoscope body 1 includes an endoscope body head 12, an endoscope body middle part 13 and an endoscope body tail 14. The endoscope body 1 is 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 for entering the body in the use state and a main channel outer opening 112 for being located outside the body in the use state. The endoscope body tail 14 is connected to an operating handle 15 for the user to operate the endoscope, and the operating handle 15 is provided with a power interface 151; the top end 121 of the endoscope body 1 is covered with an expandable The capsule 2 is composed of a capsule connecting portion 21 and a capsule free portion 22. The capsule connecting portion 21 is cylindrical and connected to the outer surface of the endoscope head 12. The capsule free portion 22 is the expandable portion of the capsule 2. The gap between the capsule free portion 22 and the top end 121 of the endoscope head 1 forms a capsule lumen 20. The maximum outer diameter of the expanded capsule free portion 22 is at least greater than the outer diameter of the endoscope head 12. The capsule free portion 22 is transparent, or at least the area corresponding to the optical component at the top end 121 of the endoscope head 1 is transparent. The capsule lumen 20 is connected to the working channel 11. Figure 1GAs shown, a lens 10, two optical windows 101, a pressure and temperature two-in-one sensor 102 are located at the top 121 of the endoscope head 12; Figure 1D , a sheath tube matched with an endoscope, when in use, a slender sheath tube body 3 is sleeved on the outside of the endoscope body 1, the sheath tube body 3 includes a sheath tube body head 32, a sheath tube body middle part 33, and a sheath tube body tail 34, the sheath tube body 3 has a sheath tube body inner opening 311 that enters the body when in use and a sheath tube body outer opening 312 that is located outside the body when in use, and a sheath tube body side branch opening 313, an adjusting button 341 is provided on the sheath tube body side branch, when the sheath tube body side branch opening 313 is connected to a negative pressure suction device (not shown), the adjusting button 341 is used to adjust whether the sheath tube body side branch inner cavity 340 is connected to the outside The outer opening 312 of the sheath body is provided with a fastening mechanism T which can be tightly connected to the tail portion 14 of the endoscope body. In this embodiment, the fastening mechanism T is composed of an arc-shaped thin-sheet embracing arm T1 and a hollow fastening knob T2. The fastening knob T2 has a circular knob outer opening T22. The embracing arm T1 is provided with two pieces. The embracing arm T1 is connected to the tail portion 34 of the sheath body through the base T12 thereon. After the internal thread T21 of the fastening knob T2 is matched with the external thread T11 of the embracing arm, the embracing arm T1 moves toward the axis L to clamp the endoscope body tail 14 part located in the embracing arm (such as Figure 1E ) enables synchronous advancement of the sheath; Figure 1F It shows that the two embracing arms T1 are separated from the tightening knob T2, and the clamping of the embracing arms T1 on the tail part 14 of the endoscope body is released. In this case, the sheath is no longer tightly combined, and the endoscope body 1 can move back and forth and rotate freely in the sheath body 3.

[0061] In order to better expand the capsule 2, there are several refinements as follows: Figure 1G The free portion 22 of the capsule is provided with a hollow protrusion 226 extending toward the distal end in a nipple-like manner; Figure 1H , a plurality of annular wrinkles 227 are provided on the free portion 22 of the capsule; Figure 1I A solid protrusion 228 extending toward the distal nipple is provided on the free portion 22 of the capsule; in order to increase the volume of the free portion 22 of the capsule after expansion, the hollow protrusion 226 and the annular wrinkle 227 structure enable the free portion 22 of the capsule to significantly increase the surface area of ​​the free portion 22 of the capsule while keeping the projection area of ​​the top end 121 of the endoscope body 1 unchanged, thereby increasing the volume of the inner cavity of the capsule after expansion, which is beneficial for the free portion 22 of the capsule to extend and expand along the axial direction of the natural cavity when filled, thereby expanding more narrow cavities; the non-hollow solid protrusion 228 can also extend and expand the narrow cavity at the front end of the capsule after expansion and has a stronger breakthrough force.

[0062] like Figure 1EThe outer opening 112 of the working channel on the endoscope handle is connected to a hollow elastic power capsule 5, which is connected to the handle 15 through an extension portion 51. The inner cavity 50 of the elastic power capsule can be filled with gas or liquid. The elastic power capsule 5 is provided with a connecting hole 52 communicating with the external space; Figure 1L When the device of the present invention is advanced in the ureter U with the combined scope and sheath, if it encounters a narrow area N and is difficult to advance, Figure 1M In vitro squeezing of the elastic power bladder 5 can fill the fluid (in this case, air) inside the bladder cavity 20, causing the free portion 22 of the bladder to expand. The narrow portion N of the ureter U is subjected to flexible radial expansion, eliminating the obstruction of the narrow portion N to the forward movement without shearing and damaging the mucosa, thus facilitating the passage of the endoscope. After the squeezing is released, the fluid in the bladder cavity 20 flows back to the elastic power bladder cavity 50, and the free portion 22 of the bladder returns to its shape before expansion. The elastic power bladder 5 can be squeezed or relaxed repeatedly with the fingers, and the bladder 2 is simultaneously filled, expanded, or restored. , making full use of the recovery ability of the elastic power capsule 5 itself, and easy to use; the connecting hole 52 on the elastic power capsule 5 is particularly suitable for gas circulation. When squeezing, the finger presses and closes the connecting hole 52, and the gas in the elastic power capsule 5 is filled into the capsule inner cavity 20. After the capsule free part 22 expands for a certain period of time, the finger is released. The recovery of the elastic power capsule 5 itself and the outflow of gas from the connecting hole 52 make the capsule free part 22 recover faster; of course, the elastic power capsule 5 can also be controlled by an external syringe or other electronically controlled perfusion device and a negative pressure suction device.

[0063] Because the outer edge 322 of the inner opening of the thin-walled sheath body 3 is relatively sharp, it is very easy to shear and damage the mucosa in the cavity when it moves forward. In order to protect the natural mucosa of the cavity, Figure 1J The flexible capsule shielding portion 23 extends outward from the junction of the capsule free portion 22 and the capsule connecting portion 21 to shield the outer edge 322 of the inner opening of the sheath body 3. This figure shows that the horizontal portion 231 of the flexible shielding portion 23 shields the outer edge 322 of the inner opening of the sheath body 3, blocking the upper opening of the scope sheath gap 130, and will not shear or damage the ureteral U mucosa when advancing in the ureter U ( Figure 1L ); further optimization scheme such as Figure 1K As shown, the horizontal portion 231 of the flexible capsule shielding portion 23 is connected with a cylindrical flange 232, which more thoroughly covers the outer edge 322 of the inner opening of the sheath body 3; combined with the expansion-type forward characteristics of the capsule free portion 22, it has a double protection effect.

[0064] When the present invention is used, the top end 121 of the head of the endoscope body 1 is extended out from the opening 311 inside the sheath body, exposing at least the free part 22 of the capsule to the outside, and the fastening mechanism T is activated to tightly connect the sheath body 3 with the endoscope body 1, thereby realizing the synchronous advance and retreat of the endoscope and sheath; when the endoscope body 1 encounters obstacles when moving forward in the natural cavity of a living body, fluid can be filled into the inner cavity 20 of the capsule through the outer opening 112 of the working channel to expand it, and the narrow part of the natural cavity can be radially and flexibly expanded to facilitate the endoscope body 1 to continue moving forward in the natural cavity; after the device reaches the target position, the fastening mechanism T is loosened, and the endoscope body 1 can freely rotate or move back and forth in the sheath body 3.

[0065] The positions of the various types of tubes described in the present invention are as follows: the head portion is toward the distal end and enters the body when in use; the tail portion is toward the proximal end and is usually located outside the body when in use; the inner opening is the distal opening, and the outer opening is the proximal opening; "forward" is toward the distal direction, and "backward" is toward the proximal direction.

[0066] The capsule 2 is preferably made of a compliant material, and can extend forward while flexibly radially expanding the natural cavity.

[0067] When using, such as Figure 1N After the sheath of the device is pushed to the target position, the embracing arm T1 is separated from the tightening knob T2, the clamping of the endoscope body tail 14 by the embracing arm T1 is released, and the endoscope body head 12 is extended from the opening 311 in the sheath body into the renal pelvis P; Figure 1O The endoscope body 1 withdraws backward from the inner cavity 31 of the sheath body, and in the gap 130 of the sheath, the free part 22 of the capsule and the shielding part 23 are deformed and tilted upward; when the head of the endoscope body 12 withdraws from the outer opening 312 of the sheath body, the capsule 2 covering the head of the endoscope body 12 is removed to expose the working channel 11, and then the endoscope body 1 is placed into the inner cavity 31 of the sheath body for subsequent lithotripsy or other medical operations (not shown).

[0068] The capsule connection portion 21 is cylindrical and is connected to the outer surface of the endoscope body head 12 in a manner that is easily detachable, in order to expose the working channel 11 for subsequent other medical operations;

[0069] Prior art endoscope systems, such as Figure 1A 、 1BAs shown, the hollow sheath tube body 3 includes a sheath tube body head 32, a sheath tube body middle part 33, and a sheath tube body tail 34. The sheath tube body is provided with a sheath tube body inner opening 311 that enters the body when in use and a sheath tube body outer opening 312 that is located outside the body when in use, and a sheath tube body side branch opening 313. An adjusting button 341 is provided on the sheath tube body side branch. When the sheath tube body side branch opening 313 is connected to a negative pressure suction device (not shown), the adjusting button 341 is used to adjust whether the sheath tube body side branch inner cavity 340 is connected to the outside. A hollow elastic sealing plug S is provided in the sheath tube body outer opening 312; the sheath core 4 includes a sheath core head 42, a sheath core middle part 43, and a sheath core tail. The sheath core inner cavity 41 is provided with a sheath core inner opening 411 and a sheath core outer opening 412, and the sheath core outer opening 412 protrudes from the sheath tube main body tail 34, and the end of the sheath core tail 44 is located outside the sheath tube main body inner cavity 31, and the end of the sheath core tail 44 is provided with a snap body 441, and the snap body 441 is snap-connected with the receiving body 342 at the end of the sheath tube main body tail 34. After the snap connection, the sheath tube and the sheath core can be combined into one and synchronously advance and retreat, and the sheath core head 42 is tapered and extends from the sheath tube main body inner opening 311. As can be seen in the figure, the top 321 of the sheath tube main body 3 and the sharp edge 322 of the sheath tube main body 3 inner opening, the guide wire G passes through the sheath core inner cavity 41 and protrudes from the sheath core inner opening 411.

[0070] The steps of ureteral nephrolithotomy in the prior art are as follows: 1. Figure 1A -2. The rigid endoscope head 12 enters the bladder through the urethra and then into the ureter U; 2. A guide wire G is inserted into the renal pelvis P along the working channel of the rigid endoscope; 3. The rigid endoscope is withdrawn, leaving only the guide wire in the urinary tract; 4. Figure 1A -3, then insert the ureteral sheath and the sheath core inside it through the guide wire; 5. Pull out the sheath core inside the ureteral guide sheath (picture omitted); 6. Figure 1B -1, and then insert the soft endoscope from the inner cavity 31 of the ureteral sheath body. 1B-2 shows that the sheath body head 32 is located near the connection between the ureter U and the renal pelvis P, and the inner opening 311 of the sheath body is facing the renal pelvis P; 1B-3 shows that the flexible endoscope body head 12 of the endoscope partially protrudes from the inner opening 311 of the sheath body and extends into the renal pelvis P; the working channel 11 opened in the soft endoscope body head 12 undertakes the functions of optical fiber lithotripsy, cooling and flushing, and stone extraction. The process of inserting the soft endoscope is cumbersome.

[0071] During the advancement of the protective endoscope device of the present invention into the natural cavity, the hard head edge of the sheath body is protected by the flexible shielding part throughout the entire process, which significantly reduces the shear damage of the mucosa during the endoscope placement process; when the natural cavity is narrowed during the endoscope placement process, the head balloon of the endoscope body is filled and expanded, and the balloon is released after radial expansion of the narrow part to facilitate subsequent passage; the endoscope and sheath are advanced synchronously, which reduces the operation steps and improves efficiency, eliminates the sheath core 4 components and also eliminates the use of the guide wire G; the head balloon expands and advances based on visualization; the head balloon expands and expands the natural cavity under pressure monitoring, and the expansion effect is more reliable; when inserted into the urethra, the head balloon can slowly radially expand the urethral membrane to protect the external urethral sphincter and avoid postoperative urinary control disorders to the greatest extent; it flexibly expands the connection between the ureter and the bladder to protect the Waldeyer sheath and avoid postoperative vesicoureteral reflux to the greatest extent; it significantly simplifies the operation steps, reduces tissue damage, greatly saves operation time, and reduces treatment costs.

[0072] Example 2:

[0073] like Figures 2A-2C In this example, the free part 22 of the capsule is provided with a fragile area 220 that is easily punctured by the guide wire G and a fragile structure 221 located in the fragile area 220. In order to meet the possible needs of the guide wire G passing through the free part 22 of the capsule in individual cases during clinical use, during the insertion process, the guide wire G is directly inserted through the endoscope working channel 11 without removing the capsule 2; the fragile area 220 is a local thin-walled area that is more prone to deformation and rupture, and the fragile structure 221 is a variety of shapes. The thin-walled structure of the guided local micro-area, in this case, a cross-shaped thinner-walled fragile structure 221 is set in the center of the fragile area 220. It is not easy to be damaged when the free part 22 of the capsule is filled and expanded, but it is easy to rupture when punctured by a thin-diameter guide wire G, but it will still hold the guide wire G after rupture. Experiments show that after the guide wire G penetrates the fragile structure 221, the free part 22 of the capsule can still be filled and expanded multiple times, even if there is a small amount of fluid leakage, it will not affect the expansion of the natural cavity of the free part 22 of the capsule.

[0074] Example 3:

[0075] like Figures 3A-3E The difference between this embodiment and embodiment 2 is that a guide wire hole 222 is preset on the free portion 22 of the capsule, and a reinforcement structure is provided around the guide wire hole 222. When the guide wire G passes through, it can still be well sealed, that is, it is difficult for the fluid to escape and leak from between the guide wire G and the guide wire hole 222. Figure 3AAn annular thick-walled reinforcing rib 223 is shown around the guidewire hole 222. The outer diameter of the guidewire hole 222 in the reinforcing rib 223 is less than or equal to the outer diameter of the guidewire G passing through the guidewire hole 222. At the same time, the wall thickness of the capsule connecting portion 21 is greater than that of the capsule free portion 22. In order to ensure that no fluid leaks from the capsule connecting portion 21 when the capsule 2 is inflated and expanded, the capsule connecting portion 21 is sealedly connected to the outer surface of the endoscope main body head 12. The wall thickness of the capsule connecting portion 21 is greater than that of the capsule free portion 22, and the capsule connecting portion 21 and the outer surface of the endoscope main body head 12 are preferably interference fit, that is, the assembled capsule connecting portion 21 is slightly deformed outward within the scope sheath gap 130. Although it is an interference fit, the characteristics of the elastic material of the capsule 2 can cause the capsule connecting portion 21 to be deformed when the capsule free portion 22 is pulled by a greater external force, thereby detaching from the endoscope main body head 12. Figure 3B It shows that when the free part 22 of the sac is in the expanded state, the guidewire hole 222 holds the guidewire G therein tightly, and the annular reinforcement rib 223 strengthens this holding force. The gas or liquid in the sac inner cavity 20 is not easy to leak from between the guidewire hole 222 and the guidewire G. This figure shows that the sharp outer edge 322 of the inner opening of the sheath body 3 touches the ureter U mucosa, which is very likely to cause shear damage when moving forward.

[0076] Another reinforcing structure of the guide wire hole 222 is as follows Figure 3C The guide wire hole 222 is connected to a tubular upper extension section 224. The upper extension section 224 can be set to a structure with unequal inner diameters, that is, the upper opening or the lower opening is slightly larger, and the larger lower opening can be used as a guide for the guide wire G when it passes through the lower opening; Figure 3D The free portion 22 of the balloon is shown in an expanded state, the upper extension section 224 wraps the guide wire G, and the fluid portion of the balloon lumen 20 does not leak or only leaks a small amount.

[0077] Figure 3E Another guide wire hole 222 reinforcement structure is shown. The guide wire hole 222 is connected to a tubular lower extension section 225. At the same time, the capsule shielding portion 23 has a soft tubular flange 232 to better protect the natural cavity mucosa.

[0078] The hollow upper extension section 224 and the lower extension section 225 are connected to the guide wire hole 222 as a whole. When the guide wire passes through the extension section, the contact area is larger, and it is not easy for fluid leakage to occur when the free part 22 of the balloon is expanded. Experiments show that even if some trace leakage occurs during actual use, it will not seriously affect the effect of the balloon expanding the natural cavity.

[0079] In order to clearly show the key structures, the change in the wall thickness of the free portion 22 of the capsule after expansion is not shown in the drawings of the present invention.

[0080] When the present invention is used for kidney stone surgery, a section of the sheath body 3 adjacent to the inner opening 311 of the sheath body is a bendable section of the sheath body, and / or a section of the endoscope body adjacent to the inner opening 111 of the working channel is a bendable section of the endoscope; the bendable section of the endoscope makes it less likely for the head of the endoscope body to have visual and operational blind spots in the renal pelvis and calyx.

[0081] When the present invention is used in a transureteral lithotripsy surgical system, it also includes at least one of an irrigation device (omitted), a lithotripsy optical fiber (omitted), a negative pressure suction device (omitted), a pressure sensor, a temperature sensor (omitted), a stone basket (omitted), and a guide wire; the pressure sensor and the temperature sensor can be arranged in the vicinity of the opening 311 in the sheath body, or in the area of ​​the head 12 of the endoscope body, to facilitate the monitoring of the pressure and temperature in the urinary tract during surgery and ensure the safety of the surgery; in order to reduce friction during insertion and operation, the free part 22 of the capsule, the endoscope body 1, the sheath body 3, and the guide wire G are provided with a hydrophilic coating.

[0082] The protective medical endoscope of the present invention significantly simplifies the operating steps, reduces tissue damage, saves operation time, and reduces treatment costs; it can be used for medical operations in various natural cavities including the cardiovascular tract, respiratory tract, ear canal, tear duct, 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 protective medical endoscope device, wherein: An endoscope, wherein an optical component is provided on an elongated endoscope body (1), the endoscope body (1) is provided with a working channel (11) running through the endoscope head and tail, the working channel (11) being provided with an inner working channel opening (111) for entering the body in a use state and an outer working channel opening (112) for being located outside the body in a use state; A sheath tube, wherein the elongated sheath tube body (3) is sleeved on the outside of the endoscope body (1), and the sheath tube body (3) is provided with an inner opening (311) of the sheath tube body that enters the body in the use state and an outer opening (312) of the sheath tube body that is located outside the body in the use state; The invention is characterized in that: the top end (121) of the endoscope body (1) is covered with an expandable capsule (2), the capsule (2) is composed of a capsule connecting portion (21) and a capsule free portion (22), the capsule connecting portion (21) is cylindrical and connected to the outer surface of the endoscope body head (12), the capsule free portion (22) is the expandable portion of the capsule (2), and the gap between the capsule free portion (22) and the top end (121) of the endoscope body (1) forms a capsule inner cavity (20); the maximum outer diameter of the expanded capsule free portion (22) is at least greater than the outer diameter of the endoscope body head (12); the capsule free portion (22) is transparent or at least the area corresponding to the optical component of the top end (121) of the endoscope body (1) is transparent; the capsule inner cavity (20) is connected to the working channel (11); A fastening mechanism (T) that can be tightly connected to the endoscope body tail (14) is provided in the area adjacent to the outer opening (312) of the sheath body. When in use, the top end (121) of the endoscope body (1) is extended out from the inner opening (311) of the sheath body, at least a portion of the capsule free portion (22) of the top end (121) is exposed to the outside, and the fastening mechanism (T) is activated to tightly connect the sheath body (3) with the endoscope body (1), thereby achieving synchronous advancement and retreat of the endoscope and the sheath. When the endoscope body (1) encounters resistance when moving forward in the natural cavity of a living body, fluid can be injected into the inner cavity (20) of the capsule through the outer opening (112) of the working channel to expand it, thereby radially and flexibly expanding the tissue at the narrow part of the natural cavity, so that the endoscope body (1) can continue to move forward in the natural cavity; after the device reaches the target position, the fastening mechanism (T) is released, and the endoscope body (1) can freely rotate or move forward and backward in the inner cavity (31) of the sheath tube; The free portion (22) of the capsule (2) is provided with a protrusion extending toward the distal end in a papillary shape; or the free portion (22) of the capsule is provided with one or more annular wrinkles (227); The free portion (22) of the capsule (2) is provided with a guide wire hole (222) for the guide wire (G) to pass through; A flexible capsule shielding portion (23) that can shield the outer edge (322) of the inner opening of the sheath tube body (3) extends outward from the junction of the capsule free portion (22) and the capsule connecting portion (21) of the capsule (2).

2. The protective medical endoscope device according to claim 1, characterized in that: The guide wire hole (222) is in contact with the guide wire (G) without a gap; a reinforcement structure is provided around the guide wire hole (222), and the reinforcement structure includes at least one of a reinforcement rib (223), an upper extension section (224), and a lower extension section (225).

3. The protective medical endoscope device according to claim 1, characterized in that: The wall thickness of the capsule connecting portion (21) of the capsule (2) is greater than that of the capsule free portion (22).

4. The protective medical endoscope device according to claim 1, wherein: The flexible capsule shielding portion (23) is provided with a cylindrical flange (232), and the cylindrical flange (232) covers the outer edge (322) of the inner opening of the sheath tube body (3).

5. The protective medical endoscope device according to claim 1, characterized in that: The outer opening (112) of the working channel is connected to a hollow elastic power sac (5). The elastic power sac (5) is squeezed to fill the fluid in the sac inner cavity (20), thereby expanding the sac free portion (22); after the squeezing is released, the fluid in the sac inner cavity (20) flows back to the elastic power sac inner cavity (50).

6. The protective medical endoscope device according to claim 1, characterized in that: A section of the sheath body head (32) adjacent to the sheath body inner opening (311) is the sheath body bendable section, and / or a section of the endoscope body head (12) adjacent to the working channel inner opening (111) is the endoscope bendable section.

7. A transureteral lithotripsy surgical system, characterized in that: The protective medical endoscope device comprises the protective medical endoscope device as described in any one of claims 1 to 6, and further comprises at least one of an irrigation device, a lithotripsy optical fiber, a negative pressure suction device, a pressure sensor, a temperature sensor, a stone basket, and a guide wire.

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