Medical endoscope, safe-insertion-type endoscope device and surgical system

By designing an inflatable capsule structure and integrated protection of the lens sheath on the head of the medical endoscope, combined with the assistance of the capsule extension tube and guidewire, the problems of mucosal shear damage and cumbersome insertion process when the endoscope is advanced in the natural cavity are solved, and more efficient and safe endoscope insertion and operation are achieved.

WO2025051251A1PCT designated stage expired Publication Date: 2025-03-13ANHUI HAPPINESS WORKSHOP MEDICAL INSTRUMENTS CO LTD

Patent Information

Application Number
PCT/CN2024/117501
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-10
Filing Date
2024-09-06
Publication Date
2025-03-13

AI Technical Summary

Technical Problem

Existing medical endoscopes are prone to cause mucosal shear damage when they are propelled in the natural cavity, especially in narrow places, and the insertion process is cumbersome and lacks effective safety protection measures.

Method used

A medical endoscope was designed, with an inflatable capsule structure on its head, combined with the integrated head protection of the lens sheath, protecting the natural cavity mucosa through the flexible capsule blocking part, and expanding forward with the assistance of the capsule extension tube and guidewire to solve the resistance in the narrow area.

Benefits of technology

It significantly reduces the risk of shear damage to the natural cavity mucosa, simplifies the insertion process, improves operating efficiency, reduces surgical time and treatment costs, and provides safer protection from vesicureteral reflux.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present patent relates to the field of medical instruments. Provided are a medical endoscope, a safe-insertion-type endoscope device and a surgical system. In the medical endoscope, the head top end of an endoscope main body is covered with an expandable balloon, the balloon comprises a balloon connecting portion and a balloon free portion, the inner surface area of the balloon free portion is connected to a hollow balloon extension pipe, and the balloon extension pipe is provided with a balloon extension pipe inner opening and a balloon extension pipe outer opening; the balloon extension pipe can extend into an endoscope operation channel directly or under the assistance of a guidewire, and the tip of the balloon extension pipe extends out of an endoscope operation channel outer opening; and the junction of the balloon free portion and the balloon connecting portion extends outward to form a flexible balloon shielding portion. When the endoscope main body is blocked when advancing into a natural orifice of a living body, the inner cavity of the balloon is filled with fluid through a perfusion gap to expand the balloon free portion, so as to radially and flexibly expand the tissue at the narrow part of the natural orifice, thereby making it convenient for the endoscope main body to advance in the expanded natural orifice to significantly reduce shearing injuries to the mucosa during the endoscope insertion process.
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Description

Medical endoscopes, safe insertion endoscope devices and surgical systems Technical Field

[0001] The present invention relates to a medical endoscope, a safe insertion endoscope device and a surgical 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 slenderer and softer, can contact natural cavities for a longer time during operation, and cause less damage than hard endoscopes. For example, in transurethral laser kidney stone surgery, the usual operation is: 1. The hard endoscope enters the bladder and ureter through the urethra; 2. Then, a guide wire is inserted into the renal pelvis through the working channel of the hard endoscope; 3. The hard endoscope is withdrawn, leaving only the guide wire in the urinary tract; 4. The ureteral sheath and the sheath core located in the sheath are then inserted through the guide wire; 5. Withdrawal out of the sheath core in 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 endoscope or soft endoscope, 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 mucosa of the natural cavity, and shear damage is difficult to avoid. When encountering a narrow part of the natural cavity, this shear damage is more serious, and even perforation of the natural cavity may occur; the safety protection measures in the existing technology during the endoscope placement process are weak or even non-existent, and the shear damage of the natural cavity mucosa is prone to secondary infection and functional disorders.

[0003] The present invention provides a medical endoscope, a safe insertion type endoscope device and a surgical system, wherein the endoscope head is provided with an expandable sac structure, the endoscope sheath has an integrated head protection, and the endoscope sheath is integrated and synchronously inserted; the soft sac shielding portion prevents the hard sheath tube main body head edge from shearing and damaging the tender mucous membrane of the natural cavity throughout the process; when the device encounters resistance when advancing in the natural cavity, fluid is filled into the inner cavity of the expandable sac from outside the body to expand it to radially flexibly expand the natural cavity, and the filling is released to restore the sac. At this time, the expanded natural cavity has not yet returned to its original state, and continued advancement will minimize the resistance. The value is particularly prominent when encountering a narrow natural cavity; the present invention fully guarantees the safety of the natural cavity of a living organism while eliminating tedious steps and improving operating efficiency.

[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 slender endoscope body, and the endoscope body is provided with a working channel running through the head and tail, the working channel having an inner working channel opening that enters the body when in use and an outer working channel opening that is located outside the body when in use; the top end of the endoscope body head is covered with an expandable capsule, the capsule consisting of a capsule connecting portion and a capsule free portion, the capsule connecting portion is cylindrical and connected to the outer surface of the endoscope body head, the capsule free portion is the expandable part of the capsule, and the gap between the capsule free portion and the top end of the endoscope body head forms the capsule inner cavity; the maximum outer diameter of the capsule free portion after expansion is at least larger than the outer diameter of the endoscope body head; the capsule free portion is transparent or at least the area corresponding to the optical component at the top end of the endoscope body head is transparent; a flexible capsule shielding portion extends outward from the junction of the capsule free portion and the capsule connecting portion.

[0007] A more prominent structure is that the inner surface area of ​​the free part of the balloon is connected to a hollow balloon extension tube, which is provided with an inner opening of the balloon extension tube located on the free part of the balloon and an outer opening of the balloon extension tube located outside the body when in use; the balloon extension tube can be inserted into the working channel of the endoscope directly or with the assistance of a guide wire, and the end of the balloon extension tube passes out from the outer opening of the working channel of the endoscope; the external fluid can enter the inner cavity of the balloon through the perfusion gap between the outer surface of the balloon extension tube and the inner surface of the working channel to expand the free part of the balloon.

[0008] The inner lumen of the balloon extension tube can not only be used for the guidewire to pass through, becoming a pathway for the guidewire to be placed and an aid for the guidewire to move along; drugs, including lubricating, diagnostic, and therapeutic drugs, can also be injected into natural cavities and pathological sinuses through the inner lumen of the balloon extension tube; and distensible, diagnostic, and therapeutic gases can also be injected; the balloon extension tube moves in the working channel of the endoscope, and can pull the free part of the balloon in the expanded state, promote its repositioning, control the degree of expansion, and adjust the shape of the free part of the balloon in the expanded state to meet the individualized operation needs of the patient or doctor; under the premise of the existence of the balloon extension tube, the external fluid filling the free part of the balloon needs to be injected into the inner lumen of the balloon through the perfusion gap between the outer surface of the balloon extension tube and the inner surface of the working channel of the endoscope.

[0009] Inserting a guide wire into the balloon extension tube allows the medical endoscope to move forward under the guidance of the guide wire or expand forward along the guide wire when the free part of the balloon is filled, thereby expanding a longer natural cavity; in order to prevent the balloon from hugging the guide wire therein when it expands, thereby affecting the expansion of the natural cavity of the free part of the balloon along the guide wire, the inner cavity of the balloon extension tube and the opening area in the balloon extension tube are preferably in non-interference contact with the guide wire inserted therein; a reinforcement structure is provided around the opening in the balloon extension tube, including an annular thick-walled reinforcement rib that bulges around the opening in the balloon extension tube, and a hollow upper thickened section and a lower thickened section that are integrated with the opening in the balloon extension tube. The guide wire passes through the thickened section, and when the free part of the balloon expands, it will not be hugged by the free part that may retract in the opening area in the balloon extension tube, thereby ensuring that the free part of the balloon can expand forward along the guide wire when it is filled.

[0010] The balloon is preferably made of compliant material and can extend forward while flexibly radially expanding the natural cavity; the balloon connection part is cylindrical and the connection with the outer surface of the endoscope main head is easy to separate. After completing the expansion task, the balloon is removed to expose the working channel, and other subsequent medical operations are performed through the working channel.

[0011] The medical endoscope in the present invention includes a flexible endoscope with a bendable endoscope body and a hard endoscope with a non-bendable endoscope body, and includes an electronic endoscope and an optical endoscope.

[0012] Better yet, a conical protrusion protruding toward the distal end is provided on the free portion of the balloon around the opening in the balloon extension tube; the flexible conical protrusion helps the endoscope to advance in the natural cavity. After the balloon is inflated, the conical protrusion is pushed further forward, synchronously expanding the natural cavity further ahead, achieving the effect of extended expansion.

[0013] One solution to increase the volume of the balloon after expansion is to provide hollow nipple-shaped protrusions around the opening of the balloon extension tube on the free part of the balloon, and / or to provide one or more annular wrinkles on the free part of the balloon; the nipple-shaped protrusions help the free part of the balloon to expand in an extended manner after filling; the annular wrinkles can significantly increase the surface area of ​​the free part of the balloon while keeping the plane projection area of ​​the top of the endoscope main body head unchanged, thereby increasing the volume of the balloon inner cavity after expansion, which is beneficial to the axial extension expansion along the natural cavity when filling, thereby expanding a longer natural cavity.

[0014] In order to ensure that the balloon can be stably expanded and expanded multiple times, the wall thickness and / or strength of the balloon connecting part of the balloon is greater than that of the balloon free part; this prevents the balloon connecting part from being affected and detached from the endoscope main body head when the balloon free part expands.

[0015] In order to facilitate the operator's operation, the outer opening of the working channel is connected to a hollow elastic power bag. Squeezing the elastic power bag can fill the fluid inside the bag into the inner cavity of the bag, causing the free part of the bag to expand; after the squeezing is released, the fluid in the inner cavity of the bag flows back to the inner cavity of the elastic power bag; usually, the gas in the inner cavity of the elastic power bag can be used.

[0016] The present invention also proposes a safe implantable endoscope device, comprising a sheath and the medical endoscope as described above, wherein the slender sheath body is sleeved on the outside of the endoscope body, and the sheath body is provided with an inner opening of the sheath body that enters the body when in use and an outer opening of the sheath body that is located outside the body when in use; in order to protect the natural cavity mucosa from being sheared by the sharp edges of the opening in the inner cavity of the sheath body, a flexible capsule shielding portion is extended outward from the junction of the free portion of the capsule and the connecting portion of the capsule, which can shield or cover the outer edge of the inner cavity opening of the sheath body.

[0017] Furthermore, the flexible capsule shielding portion extending outward from the junction of the capsule free portion and the capsule connecting portion is provided with a cylindrical flange, which fully covers the outer edge of the inner opening of the sheath; the outer edge of the inner opening of the thin-walled sheath is relatively sharp, and it is very easy to shear and damage the inner membrane of the cavity it contacts when moving forward. The flexible capsule shielding portion fully covers the outer edge of the inner opening of the sheath, eliminating the above-mentioned shear damage risk. Combined with the characteristics of the expansion-type forward movement of the free portion of the capsule, it has a double protection effect on the natural cavity mucosa.

[0018] A fastening mechanism that can be tightly connected to the tail of the endoscope body is provided in the area adjacent to the outer opening of the sheath body. When in use, the top of the endoscope body head is protruded from the inner opening of the sheath body, exposing at least a part of the free part of the capsule to the outside, and the fastening mechanism is activated to tightly connect the sheath body with the endoscope body, thereby realizing the synchronous advance and retreat of the endoscope body and the sheath body of the sheath; when the endoscope 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 perfusion gap to expand the free part of the capsule, and radially flexibly expand the tissue at the narrow part of the natural cavity, so as to facilitate the movement of the endoscope body in the expanded natural cavity; after the device reaches the target position, the fastening mechanism is loosened, the sheath-in-one state is released, and the endoscope body can freely rotate or move back and forth in the inner cavity of the sheath body.

[0019] A fastening mechanism that can be tightly connected to the tail of the endoscope body is provided at the outer opening of the sheath body. The fastening mechanism can be set at the tail of the sheath body or at the tail of the endoscope body. It is preferably set at the tail of the sheath body. The fastening mechanism can also be an independent component, which is connected to the tail of the endoscope body and the tail of the sheath body when in use; the fastening mechanism not only allows the sheath to move as a whole, but also ensures the stability of the relative position of the capsule, the endoscope and the sheath.

[0020] To facilitate operation, a section adjacent to the opening in the sheath body is a bendable section of the sheath, and / or a section adjacent to the opening in the working channel of the endoscope body is a bendable section of the endoscope; the bendable section makes it less likely for the endoscope to have visual and operational blind spots in the renal pelvis and calyx.

[0021] A transureteral lithotripsy surgical system includes, in addition to the above-mentioned safe implantable medical endoscope device, 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 vicinity of the opening in the sheath body, or in the head 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 the friction with the natural cavity mucosa and various components, at least one or more of the outer surface of the free part of the capsule, the outer surface of the endoscope body, the inner surface of the sheath body, the outer surface of the sheath body, the outer surface of the capsule extension tube, and the inner surface of the endoscope working channel are provided with a hydrophilic coating.

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

[0024] 1. During the advancement of the endoscope into the natural cavity, the hard head edge of the sheath body is protected by the flexible capsule shielding part throughout the entire process, which significantly reduces the shear damage to the mucosa during the insertion 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 fastening mechanism enables the endoscope and sheath to be advanced synchronously, reducing the operation steps and improving 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 safer and 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 the occurrence of 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] 8. During the advancement of the endoscopic device along the natural cavity, lubricating and smooth muscle relaxing drugs or contrast agents can be injected into the natural cavity through the lumen of the balloon extension tube to ensure the safety of the operation.

[0032] The present invention significantly simplifies surgical operation steps, reduces tissue damage, greatly saves operation time, and reduces treatment costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The accompanying drawings which do not limit the present invention are as follows:

[0034] FIG1A is a schematic diagram showing the use of a sheath, sheath core, and guidewire in the prior art;

[0035] 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;

[0036] FIG1B is a schematic diagram showing the endoscope body 1 entering the sheath body 3 in the prior art;

[0037] 1B-1: The endoscope body 1 enters the sheath body 3, and the flexible head portion 12 of the endoscope body protrudes from the opening 321 in the sheath body; 1B-2: The sheath body head 32 is located near the junction of the ureter U and the renal pelvis P; 1B-3: The flexible head portion 12 of the endoscope body protrudes from the opening in the sheath body and extends into the renal pelvis P;

[0038] FIG1C is a schematic diagram of an endoscope according to Example 1. The endoscope head 12 is covered with an expandable bladder 2. The free portion 22 of the bladder is connected to a bladder extension tube 24. The bladder extension tube 24 extends from the outer opening 112 of the endoscope working channel. The outer opening 242 of the bladder extension tube is adapted to receive a blocking member 243. The bladder shielding portion 23 is provided with a cylindrical flange 232.

[0039] FIG1D is a schematic diagram of the sheath body 3 of Example 1, showing a cross-section of the fastening mechanism T of the sheath tail 34;

[0040] FIG1E is a schematic diagram showing the combination of the endoscope body 1 and the sheath body 3 of Example 1, with a partial cutaway view showing the elastic power bladder 5 connected to the bladder body 2 at the head of the endoscope body, and the fastening mechanism T of the sheath tail 34 connected to the endoscope handle 15;

[0041] FIG1F is a schematic diagram showing 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;

[0042] FIG1G is a perspective view of the elastic power bladder 5 connected to the endoscope handle 15 according to Example 1;

[0043] FIG1H is a cross-sectional view of the free portion 22 of the endoscope body head 12 in an unexpanded state, with the extension tube 24 of the endoscope located in the working channel 11 and encountering the ureteral stenosis N;

[0044] FIG1I is a cross-sectional view of the expanded free portion 22 of the bladder in Example 1, in which the narrowed portion N of the ureter U is radially expanded;

[0045] FIG1J is a cross-sectional view of the expanded state of the free portion 22 of the balloon in Example 1, wherein the guide wire G is passed through the lumen 240 of the balloon extension tube, and the free portion 22 of the balloon is expanded under the guidance of the guide wire G;

[0046] FIG1K : After the endoscope and sheath are advanced integrally to the junction of the ureter U and the renal pelvis P in Example 1, a partial cross-section shows the separation of the embracing arm T1 and the tightening knob T2, and the endoscope main body head 12 is inserted through the sheath main body head 32 into the renal pelvis P;

[0047] FIG1L : The endoscope body of Example 1 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 part of the capsule;

[0048] FIG2A is a cross-sectional view of a tapered protrusion 228 extending distally in a papillary manner in the opening 241 region of the balloon extension tube 24 of Example 2;

[0049] FIG2B is a cross-sectional view of the guide wire G passing through the lumen 240 of the balloon extension tube of Example 2;

[0050] 3A is a schematic diagram of the annular wrinkles 227 on the free portion 22 of the bladder, the annular thick-walled reinforcement ribs 223 in the opening 241 of the bladder extension tube 24, and the downward thickening section 225 of Example 3;

[0051] FIG3B is a partial cross-sectional view of the guide wire G passing through the lumen 240 of the balloon extension tube of Example 3;

[0052] FIG4A is a schematic diagram of an upwardly thickened section 224 in the peripheral area of ​​the opening 241 in the balloon extension tube of Example 4;

[0053] FIG4B is a partial cross-sectional view of the guide wire G passing through the lumen 240 of the balloon extension tube of Example 4;

[0054] FIG5A is a cross-sectional view of a hollow nipple-like protrusion 226 protruding distally in the peripheral area of ​​the opening 241 in the balloon extension tube 24 of Example 5;

[0055] FIG5B is a cross-sectional view of the guide wire G inserted into the lumen 240 of the balloon extension tube of Example 5, wherein the guide wire G is not cut. DETAILED DESCRIPTION

[0056] The embodiments of the present invention are not limited to the following:

[0057] Example 1:

[0058] As shown in FIG1C , a safe insertion type medical endoscope device is provided. The 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 when in use and a main channel outer opening 112 for being located outside the body when in use. The endoscope body tail 14 is connected with an operating handle 15 for the user to operate the endoscope. The operating handle 15 is provided with a power interface 151. The top end 121 of the head of the endoscope body 1 is covered with an inflatable capsule 2. The capsule is composed of a capsule connecting part 21 and a capsule free part 22. The capsule connecting part 21 is cylindrical and connected to the outer surface of the endoscope body head 12. The capsule free part 22 is the inflatable part of the capsule 2. The capsule free part 22 is connected to the endoscope body. The gap between the top end 121 of the head of the endoscope body 1 forms the capsule inner cavity 20; the maximum outer diameter of the expanded capsule free part 22 is at least larger than the outer diameter of the top area of ​​the endoscope body head 12; the capsule free part 22 is transparent or at least the area corresponding to the optical component 121 of the top endoscope body 1 head (as shown in Figure 1I) is transparent; the capsule inner cavity 20 is connected to the working channel 11; the inner side of the capsule free part 22 is connected to a hollow capsule extension tube 24, most of the capsule extension tube 24 is located in the working channel 11, and the capsule extension tube inner cavity 240 is provided with two openings, namely the capsule extension tube inner opening 241 and the capsule extension tube inner and outer openings 242. In this example, the proximal end of the capsule extension tube 24 extends from the endoscope working channel outer opening 112 on the handle extension section 152, and the capsule extension tube outer opening 242 can be blocked by a blocking body 243.

[0059] Because the outer edge 322 of the inner opening of the thin-walled sheath body 3 (Figure 1A-1) is relatively sharp, it is very easy to shear and damage the mucosa in the natural cavity it contacts when advancing. In order to protect the mucosa of the natural cavity, a flexible capsule shielding portion 23 that can block or cover the outer edge 322 of the inner opening of the sheath body 3 is extended outward at the junction of the capsule free portion 22 and the capsule connecting portion 21. The horizontal wing 231 of the flexible capsule shielding portion 23 is connected with a cylindrical flange 232, and the cylindrical flange 232 more thoroughly covers the outer edge 322 of the inner opening of the sheath. Figure 1E shows that the flexible shielding portion 23 blocks the outer edge 322 of the inner opening of the sheath body 3, blocks the opening on the mirror sheath gap 130, and will not shear and damage the ureteral U mucosa when advancing in the ureter U; combined with the characteristic that the capsule free portion 22 can advance in an expandable manner, it has a double protection effect.

[0060] As shown in Figure 1D, the sheath tube that matches the endoscope (the "sheath tube" and the "sheath tube body" are described equivalently in this article) is a slender sheath tube body 3 that is sleeved on the outside of the endoscope body 1 when in use. 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 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 is connected to a negative pressure suction device (not shown), the adjusting button 341 is used to control whether the sheath tube side branch lumen 340 is connected to the outside; a fastening mechanism T that can be tightly connected to the endoscope body tail 14 is provided at the sheath tube body outer opening 312, which in this embodiment is composed of an arc The embracing arm T1 is composed of a thin sheet and a hollow fastening knob T2. The fastening knob T2 has a circular knob outer opening T22. The embracing arm T1 is set to two pieces. The embracing arm T1 is connected to the tail part 34 of the sheath tube 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 two embracing arms T1 move radially toward the axis L, clamping the tail part 14 of the endoscope body located in the embracing arm (as shown in Figure 1E) so that the sheath ("sheath" in this article refers to the endoscope and the sheath tube) can be pushed forward synchronously; Figure 1F shows that the two embracing arms T1 are separated from the fastening knob T2, and the clamping of the tail part 14 of the endoscope body by the embracing arm T1 is released. In this case, the sheath is no longer tightly combined, and the endoscope body 1 can move and rotate freely back and forth in the sheath tube body 3.

[0061] As shown in Figures 1E and 1G, a hollow elastic power capsule 5 is connected to the outer opening 112 of the working channel on the endoscope handle. The elastic power capsule 5 is sleeved with the handle extension section 152 (see Figure 1C) through the extension portion 51, so that the outer opening 112 of the endoscope working channel is connected to the elastic power capsule lumen 50. The proximal end of the capsule extension tube 24 protrudes from the outer opening 112 of the endoscope working channel and is located in the elastic power capsule lumen 50. When in use, the blocking body 243 is first inserted into the outer opening 242 of the capsule extension tube to block it. The inner cavity 50 of the power sac can be filled with gas or liquid, and the inner cavity 50 of the elastic power sac is provided with a connecting hole 52 (not shown) communicating with the external space; when the endoscope sheath is advanced in the ureter U and encounters a narrow place N that makes it difficult to advance (as shown in FIG1H ), the elastic power sac 5 can be squeezed in vitro to fill the fluid (in this case, air) inside the sac into the inner cavity 20 of the sac through the perfusion gap 110. The perfusion gap 110 refers to the gap between the outer surface of the sac extension tube 24 and the inner surface of the endoscope working channel 11, as shown in FIG1H . 1I, after the fluid enters the bladder lumen 20, the bladder free portion 22 expands, and the stenosis N of the ureter U is subjected to flexible radial expansion. Without shearing and damaging the mucosa, the stenosis N eliminates the obstruction to the forward movement, which is beneficial to the passage of the endoscope. After the squeezing is released, the fluid in the bladder lumen 20 flows back to the elastic power bladder lumen 50, and the bladder free portion 22 returns to its shape before expansion. The elastic power bladder 5 can be squeezed or relaxed repeatedly with the fingers, and the bladder free portion 22 is simultaneously filled, expanded or restored, making full use of the elastic power bladder. 5 has its own recovery ability and is easy to use. The connecting hole 52 on the elastic power bladder 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 bladder 5 is filled into the bladder inner cavity 20. The free part 22 of the bladder expands for a certain period of time. After releasing the finger, the elastic power bladder 5 recovers itself and the gas quickly flows out of the connecting hole 52, so that the free part 22 of the bladder recovers faster. Of course, the elastic power bladder 5 can also be controlled by an external syringe or other electronically controlled perfusion device or negative pressure suction device.

[0062] When the device of the present invention moves forward in the expansion of the natural cavity, in some cases, if it is necessary to proceed under the guidance of the guide wire G, the guide wire G can be inserted through the lumen 240 of the balloon extension tube. Figure 1J shows that the guide wire G passes through the opening 241 in the balloon extension tube, and the free part 22 of the balloon is in a filled and expanded state. In this case, the free part 22 of the balloon is filled and expanded along the guide wire G, thereby better expanding the natural cavity.

[0063] The inner cavity 240 of the balloon extension tube can not only allow the guide wire G to pass through, but also serve as a passage for the guide wire G to be inserted and a guide for the guide wire G to move along; after the occluding body 243 is pulled out from the outer opening 242 of the balloon extension tube, drugs can be injected into the natural cavity through the inner cavity 240 of the balloon extension tube, including lubricating, diagnostic, and therapeutic drugs, such as smooth muscle relaxants, contrast agents, etc.; expansive, diagnostic, and therapeutic gases can also be injected; the balloon extension tube 24 moves in the working channel 11 of the endoscope, and can pull the free part 22 of the balloon in the expanded state, promote its reset, control its expansion degree, and adjust the shape of the free part 22 of the balloon in the expanded state, so as to meet the needs of individualized operation of patients or doctors.

[0064] As shown in Figure 1I, there is a lens 10 and two optical windows 101 located at the top 121 of the head of the endoscope body 1; a two-in-one pressure and temperature sensor 102. The pressure sensor can monitor the pressure when the free part 22 of the capsule expands, thereby adjusting the radial expansion force, effectively expanding the narrow natural cavity while ensuring operational safety. The temperature sensor can monitor temperature changes during the lithotripsy process to avoid high-temperature damage.

[0065] When the present invention is used, the top end 121 of the head of the endoscope body 1 is appropriately extended from the opening 311 in the sheath body, at least the free part 22 of the capsule is exposed to the outside, and the fastening mechanism T is activated to tightly connect the sheath body 3 and the endoscope body 1, so as to realize 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 perfusion gap 110 to make it expand, and the narrow part of the cavity can be radially and flexibly expanded, which is beneficial to the subsequent advancement of the endoscope body 1; after the sheath body 3 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 3.

[0066] As shown in Figure 1K, after the sheath of the device is pushed to the target position as a whole, the tightening knob T2 is rotated outside the body to separate the embracing arm T1 from the tightening knob T2, and the clamping of the embracing arm T1 on the tail 14 of the endoscope body is released, and the head 12 of the endoscope body protrudes from the inner opening 311 of the sheath body into the renal pelvis P; as shown in Figure 1L, the endoscope body 1 withdraws backward from the inner cavity 31 of the sheath body, and the shielding part 23 of the free part of the capsule in the gap 130 of the sheath is deformed and tilted upward; when the head 12 of the endoscope body withdraws from the outer opening 312 of the sheath, the capsule 2 covering the head 12 of the endoscope body together with the capsule extension tube 24 are taken out through the upper opening 111 or the lower opening 112 of the working channel 11 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 (figure omitted).

[0067] The capsule connection portion 21 is cylindrical and is connected to the outer surface of the endoscope main body head 12 in a manner that is easily detachable in order to expose the working channel for subsequent other medical operations.

[0068] The positions of the various types of tubes described in the present invention are as follows: the head portion is toward the distal end, which enters the body when in use; the tail portion is toward the proximal end, which is usually located outside the body when in use; the inner opening is the distal opening, which is located inside the body when in use; the outer opening is the proximal opening, which is located outside the body when in use; "forward" is toward the distal direction, and "backward" is toward the proximal direction; "up" and "front" are toward the distal end; "down" and "back" are toward the proximal end.

[0069] The capsule 2 is preferably made of a compliant material, and can extend forward while flexibly radially expanding the natural cavity.

[0070] The endoscope system of the prior art is shown in Figures 1A and 1B, wherein the hollow sheath body 3 includes a sheath body head 32, a sheath body middle portion 33, and a sheath body tail 34. The sheath has an inner opening 311 of the sheath body that enters the body when in use, an outer opening 312 of the sheath body that is located outside the body, and a sheath body side branch opening 313. An adjusting button 341 is provided on the sheath body side branch. When the sheath 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 side branch lumen 340 is connected to the outside. A hollow elastic sealing plug S is provided in the sheath outer opening 312; the sheath core 4 includes a sheath core head 42, a sheath core middle portion 4 3. The sheath core tail 44. The sheath core inner cavity 41 is provided with a sheath core inner opening 411 and a sheath core outer opening 412. The sheath core outer opening 412 protrudes from the sheath tube main body tail 34. The end of the sheath core tail 44 is located outside the sheath tube main body inner cavity 31. The end of the sheath core tail 44 is provided with a snap body 441. 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 and moved forward and backward synchronously. The sheath core head 42 is tapered and extends from the sheath tube main body inner opening 311. The top 321 of the sheath tube main body 3 and the sharp edge 322 of the sheath tube inner opening can be seen in the figure. The guide wire G passes through the sheath core inner cavity 41 and protrudes from the sheath core inner opening 411.

[0071] The steps of ureteral renal stone surgery in the prior art are as follows: 1. As shown in Figure 1A-2, the rigid endoscope head 12 is passed through the urethra into the bladder 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. As shown in Figure 1A-3, a ureteral sheath and the sheath core inside the guide wire are inserted; 5. The sheath core inside the ureteral guide sheath is withdrawn (not shown); 6. As shown in Figure 1B-1, the flexible endoscope is then passed through the ureteral guide sheath to The inner cavity 31 of the sheath tube body is inserted, and 1B-2 shows that the head of the sheath tube body 32 is located near the connection between the ureter U and the renal pelvis P, and the opening 311 in the sheath tube body is facing the renal pelvis P; 1B-3 shows that the flexible endoscope body head 12 of the endoscope partially protrudes from the opening 311 in the sheath tube and extends into the renal pelvis P; the working channel 11 opening at the head of the soft endoscope head undertakes the functions of light lithotripsy, cooling and flushing, and stone extraction. The soft endoscope insertion operation process under the existing technology is cumbersome and has no safety protection.

[0072] 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 sheath is 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 moves forward 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.

[0073] Example 2:

[0074] As shown in Figure 2A, in this example, a conical protrusion 228 extending toward the distal end is provided on the free portion 22 of the balloon around the opening 241 in the balloon extension tube. The flexible conical protrusion helps to advance the endoscope in the cavity. After the balloon 2 is inflated, the conical protrusion 228 is pushed forward, synchronously expanding the cavity in front, achieving the effect of extended expansion.

[0075] As shown in 2B , the guidewire G passes through the inner cavity 240 of the balloon extension tube and the tapered protrusion 228 thereon, and the free portion 22 of the balloon can be filled and expanded under the guidance of the guidewire G to better expand the natural cavity, especially the narrow natural cavity.

[0076] Example 3:

[0077] As shown in Figure 3A, the difference between this embodiment and embodiment 2 is that in order to strengthen the cooperation between the sac 2 and the guide wire G, that is, to prevent the opening 241 area in the sac extension tube from being squeezed inward and tightly embraced with the guide wire G when the sac free part 22 expands, so that the expanded free part 22 cannot stretch along the guide wire, an annular thick-walled reinforcement rib 223 and a downward thickening section 225 are provided in the opening 241 area in the sac extension tube, so that the free part 22 of the sac does not tightly embrace the guide wire G when it expands.

[0078] In order to increase the volume after expansion under the same filling pressure, a plurality of annular wrinkles 227 that can increase the area are provided on the free part 22 of the sac; FIG3B shows the guide wire G inserted into the lumen 240 of the sac extension tube; the annular wrinkles 227 on the free part 22 of the sac significantly increase the surface area of ​​the free part 22 of the sac while keeping the projection area of ​​the endoscope head top 121 unchanged, thereby increasing the volume of the sac lumen after expansion, which is beneficial for the free part 22 of the sac to extend and expand axially along the natural cavity when filled, and can fill and expand a longer narrow cavity at one time.

[0079] Example 4:

[0080] As shown in FIG. 4A and FIG. 4B , the difference from Example 3 is that an upwardly thickened section 224 is provided in the area surrounding the opening 241 in the balloon extension tube, the purpose of which is still to prevent the balloon free portion 22 from hugging the guide wire G when it expands.

[0081] Example 5:

[0082] As shown in FIG5A , a hollow nipple-shaped protrusion 226 protruding distally is provided in the peripheral area of ​​the opening 241 in the balloon extension tube; the hollow nipple-shaped protrusion 226 can be more easily extended forward when the balloon free portion 22 is filled, thereby increasing the range of expansion and extending the axial distance of expansion; FIG5B shows the guide wire G inserted into the inner cavity 240 of the balloon extension tube; to ensure that no fluid leaks from the balloon connecting portion 21 when the balloon is filled and expanded, the balloon connecting portion 21 is sealedly connected to the outer surface of the endoscope main head 12, the wall thickness of the balloon connecting portion 21 is greater than that of the balloon free portion 22, and the balloon connecting portion 21 and the outer surface of the endoscope main head 12 are preferably interference fit. After assembly, the balloon connecting portion 21 is located in the scope sheath gap 130. Although it is an interference fit, the characteristics of the elastic material of the balloon 2 can cause the balloon connecting portion 21 to deform upward when the balloon free portion 22 is pulled by a greater external force, and eventually detach from the endoscope main head 12.

[0083] 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.

[0084] When the present invention is used for kidney stone surgery, a section adjacent to the inner opening 311 of the sheath body is a bendable section of the sheath body, and / or a section adjacent to the inner opening 111 of the working channel of the endoscope body is a bendable section of the endoscope (as shown in FIG1K ); the bendable section makes it less likely for the endoscope to have visual and operational blind spots in the renal pelvis and calyx.

[0085] 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, and can also be arranged at the head 12 of the endoscope body, so as to facilitate the monitoring of the pressure and temperature in the urinary tract during the operation and ensure the safety of the operation; 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.

[0086] The safe implantable medical endoscope of the present invention significantly simplifies the operating steps, reduces tissue damage, saves surgical 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 medical endoscope, wherein an optical component is provided on a slender endoscope body (1), the endoscope body (1) is provided with a working channel (11) running through the head and tail, the working channel (11) being provided with an inner working channel opening (111) for entering the body when in use and an outer working channel opening (112) for being located outside the body when in use; Features: The top end (121) of the endoscope body (1) is covered with an expandable sac (2), and the sac (2) is composed of a sac connecting portion (21) and a sac free portion (22). The sac connecting portion (21) is cylindrical and connected to the outer surface of the head (12) of the endoscope body (1), and the sac free portion (22) is the expandable part of the sac (2). The gap between the sac free portion (22) and the top end (121) of the endoscope body (1) forms a sac inner cavity (20); the maximum outer diameter of the expanded sac free portion (22) is at least greater than the outer diameter of the endoscope body head (12); the sac 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 inner surface area of ​​the sac free portion (22) is connected to a hollow sac extension tube (24), and the sac extension tube (24) is provided with a sac extension tube. The long tube has an inner opening (241) and an outer opening (242) of the balloon extension tube; the balloon extension tube (24) can be directly or with the assistance of a guide wire (G) inserted into the endoscope working channel (11), and the end of the balloon extension tube (24) passes out from the outer opening (112) of the endoscope working channel; the fluid can enter the balloon lumen (20) through the perfusion gap (110) between the outer surface of the balloon extension tube (24) and the inner surface of the working channel (11); a flexible balloon shielding portion (23) extends outward from the junction of the balloon free portion (22) and the balloon connecting portion (21); when the endoscope body (1) encounters obstacles when moving forward in the natural cavity of a living body, the fluid can be filled into the balloon lumen (20) through the perfusion gap (110) to expand the balloon free portion (22), radially flexibly expand the tissue at the narrow part of the natural cavity, and facilitate the endoscope body (1) to move forward in the expanded natural cavity.

2. A medical endoscope according to claim 1, characterized in that: The free part (22) of the bladder body is provided with a conical protrusion (228) protruding toward the distal end and located in the peripheral area of ​​the opening (241) in the bladder body extension tube.

3. A medical endoscope according to claim 1, characterized in that: The free part (22) of the bladder is provided with a hollow nipple-shaped protrusion (226) located in the peripheral area of ​​the opening (241) in the bladder extension tube, and / or the free part (22) of the bladder is provided with one or more annular folds (227).

4. A medical endoscope according to claim 1, characterized in that: A reinforcement structure is provided in the peripheral area of ​​the opening (241) in the bladder extension tube connected to the bladder free portion (22), including at least one of an annular thick-wall reinforcement rib (223), an upper thickening section (224), and a lower thickening section (225).

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

6. A medical endoscope according to claim 1, characterized in that: The wall thickness and / or strength of the capsule connecting portion (21) of the capsule (2) is greater than that of the capsule free portion (22).

7. A safe implantable endoscope device, characterized in that: It comprises a sheath and a medical endoscope as described in any one of claims 1 to 6, wherein an elongated sheath body (3) is sleeved outside the endoscope body (1), and the sheath body (3) is provided with an inner opening (311) of the sheath body that enters the body when in use, and an outer opening (312) of the sheath body that is located outside the body when in use; a flexible capsule shielding portion (23) that extends outward from the junction of the capsule free portion (22) and the capsule connecting portion (21) and that can shield or cover the outer edge (322) of the inner opening of the sheath body cavity (31).

8. The safe insertion endoscope device according to claim 7, characterized in that: A flexible capsule shielding portion (23) that can shield the outer edge (322) of the inner opening of the sheath tube main body inner cavity (31) extends outward from the junction of the capsule free portion (22) and the capsule connecting portion (21); 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.

9. The safe insertion endoscope device according to claim 7, characterized in that: A fastening mechanism (T) that can be tightly connected to the tail end of the endoscope body (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 head of the endoscope body (1) is extended out from the inner opening (312) of the sheath body, exposing at least a portion of 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 achieving synchronous advancement and retreat of the endoscope body (1) and the sheath body (3); 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 body.

10. A transureteral lithotripsy surgical system, characterized in that: It comprises the safe insertion type endoscope device as described in any one of claims 7 to 9, and also 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.

Citation Information

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