Arthroscopic approach water leakage prevention device

Abstract

The present application relates to a kind of arthroscopic approach water leakage prevention device, including the elastic cover with dome structure, the sealing valve being arranged in the center position of cover and negative pressure suction mechanism, sealing valve has the conical hollow structure extending to base direction and gradually reducing outer diameter, reverse compensation sealing is realized using joint cavity infusion liquid pressure, cover base edge is equipped with flexible sealing skirt, by the negative pressure interface connection external negative pressure source, so that cover and skin form negative pressure sealing space, the device can be connected in series by negative pressure interface multiple occluder, and equipped with detachable guide rod auxiliary coaxial positioning.The present application uses non-insertion type surface adsorption occlusion, effectively solve the space interference and tissue damage problem in multiple tunnel operation, realize the dynamic water stop of pressure self-adaption, with the advantages of simple operation, sealing stable, strong dissection adaptability, can significantly improve the operation visual clarity and maintain joint cavity pressure stability.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a water-proof device for arthroscopic access and instrument channel for arthroscopic surgery. Background Technology

[0002] In arthroscopic surgeries (such as anterior and posterior cruciate ligament reconstruction of the knee), surgeons need to make incisions in the skin to create a surgical approach. To ensure a clear surgical view and maintain joint cavity stability, saline solution is usually injected into the joint cavity to create space and maintain a certain pressure. However, the injected fluid can leak out through the established surgical approach, leading to decreased joint cavity pressure, blurred vision, and intraoperative bleeding.

[0003] Currently, the commonly used solutions in clinical practice mainly fall into the following two categories: The first type is threaded sealing sleeves, such as... Figure 1 As shown, this device is fixed to the skin tissue by being screwed in through the threads on the outer circumference of the tube. Its proximal end has a sealing cap with an elastic valve. A puncture core (guide head) passing through the center of the tube guides the threaded sealing cannula into the skin tissue during initial insertion. The head of the puncture core is usually rounded to prevent damage to surrounding tissue from the transparent tube wall edge and provides dynamic water-stopping during instrument insertion and withdrawal. However, the sealing cap and water inlet of this type of device have a large radial dimension, far exceeding the diameter of the surgical approach. In surgical scenarios involving multiple adjacent approaches, the large tails of adjacent cannulas are prone to physical interference, resulting in the cannula not being fully screwed in or having a limited angle. Furthermore, the length of the puncture core / guide head and the tube itself is also relatively large, which can easily cause physical interference within the joint cavity.

[0004] The second type is the elastic shielding sleeve (with a channel-type tunnel plug), as shown in the attached... Figure 2 As shown, the cannula is typically made of flexible polymer material with elastic flanges at both ends. During use, the elastic flanges are inserted into the joint cavity, and an elastic valve within the central channel provides access for instruments. While such devices are relatively lightweight and cause minimal tissue damage, the insertion of the elastic flanges into the joint cavity is a cumbersome and time-consuming process. Furthermore, because it relies primarily on the elasticity of the flanges for fixation, the cannula is prone to displacement or being pulled out of the tunnel by instruments during frequent instrument switching or large-angle manipulations, leading to increased water usage, unstable arthroscopic pressure, and bleeding. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide an arthroscopic approach water-proof device that is compact in size to prevent interference, firmly fixed and not easy to fall off, and causes little tissue damage.

[0006] To solve the above-mentioned technical problems, the present invention proposes an arthroscopic access leak-proof device, including a cover, a sealing valve and a negative pressure adsorption mechanism; The cover is made of elastic medical material and has a raised dome structure and a base edge located at the bottom of the dome. The sealing valve is located at the center of the cover and has a through-hole self-sealing incision for surgical instruments to enter and exit while maintaining airtightness; the negative pressure adsorption mechanism includes at least one negative pressure interface on the cover, which penetrates the cover wall and communicates with the inner cavity of the cover; in use, the negative pressure interface is used to connect to an external negative pressure source to form a negative pressure sealing space between the base edge and the skin.

[0007] Compared with existing technologies, the present invention has the following significant advantages and advancements: 1) The device of this invention adopts a surface adsorption structure, and its dome height and radial dimensions are much smaller than those of traditional sleeves with large sealing caps and water injection interfaces, completely solving the spatial interference problem of multi-access operations. Through non-insertion positioning and flattened design, this invention allows multiple caps to fit closely side by side during multi-access surgery without physical impact or angular interference, providing doctors with a wider operating space.

[0008] 2) This invention only contacts the skin surface through the edge of the flexible base, without the need for mechanical compression or expansion of the soft tissue at the tunnel opening as in existing threaded sleeves. This greatly protects the integrity of the joint capsule and surrounding ligaments, avoids problems such as postoperative local swelling, pain and slow wound healing caused by iatrogenic damage to the tissue at the tunnel opening, and reduces postoperative complications.

[0009] 3) This invention generates continuous adsorption force through an external negative pressure source, ensuring that the device remains firmly locked on the skin surface even when instruments are frequently inserted and removed or swing at large angles, thus completely solving the problem of dislocation caused by instruments in traditional tunnel plugs. Attached Figure Description

[0010] The invention will now be further described with reference to the accompanying drawings.

[0011] Figure 1 This is a schematic diagram of the structure of a threaded sealing sleeve in the prior art.

[0012] Figure 2 This is a schematic diagram of the structure of an elastic shielding sleeve in the existing technology.

[0013] Figure 3 This is a schematic diagram of the structure of the arthroscopic access water-proof device in an embodiment of the present invention.

[0014] Figure 4 yes Figure 3 An internal diagram.

[0015] Figure 5 This is a schematic diagram illustrating the use of the guide rod.

[0016] Reference numerals: 1. Cover; 2. Sealing valve; 3. Flexible sealing skirt; 4. Negative pressure interface; 5. Handle; 6. Reinforcing rib; 7. Conical hollow structure; 8. Guide rod; 31. Outer skirt; 32. Inner skirt; 11. Tube body; 12. Sealing cap; 13. Puncture core; 21. Elastic flange; 22. Sleeve; 23. Elastic valve. Detailed Implementation

[0017] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0018] See Figures 3 to 5 This embodiment provides an arthroscopic access leak-proof device, whose core design concept lies in changing the traditional "insertion-type" sealing logic and adopting a "surface adsorption-type" non-invasive sealing solution. The device mainly includes a cover 1, a sealing valve 2 set in the center of the cover 1, and a negative pressure adsorption mechanism set on the cover 1.

[0019] The cover 1 is made of a biocompatible elastic medical material (such as medical-grade silicone or thermoplastic elastomer) to ensure safety when in contact with human skin and to provide the necessary elastic deformation capacity. The cover 1 has an overall upward-convex dome structure. This dome design not only creates a buffer cavity inside the cover 1 to accommodate spilled fluids but also utilizes the mechanical stability of a hemispherical shape. When external negative pressure is applied, the dome structure can evenly distribute the pressure, preventing excessive local deformation. Furthermore, this convex structure provides ample space for the internal reinforcing ribs 6 and the conical hollow structure 7, ensuring that the instrument handles do not prematurely contact the surface of the cover 1 during frequent insertion and removal of surgical instruments, increasing operational flexibility.

[0020] See Figure 4 and Figure 5 The sealing valve 2 is located at the center of the top of the cover body 1. The center of the sealing valve 2 has a through self-sealing slit (preferably a cross-shaped slit) that is in a naturally closed state without external force.

[0021] The cover 1 is equipped with a negative pressure port 4, which penetrates the wall of the cover 1 and communicates with the inner cavity of the cover. The port design preferably conforms to standard medical Luer connector specifications. In actual cruciate ligament reconstruction surgery, three or more bone tunnels are typically created. This embodiment allows multiple occlusion devices to be connected in series via the negative pressure port 4. The surgeon can connect the first port of the first occlusion device to the negative pressure suction source in the operating room, connect its second port to the first port of the second occlusion device via a flexible tube, and seal the unused port of the last device with a matching end plug. This series design greatly simplifies the tubing layout during surgery; the surgeon only needs to operate one negative pressure switch to simultaneously and securely occlude multiple bone tunnels. Compared to pulling a separate tube for each tunnel, this solution significantly reduces tubing interference on the operating table and lowers the risk of contamination of the sterile operating area by messy tubing. Preferably, in this embodiment, the sealing valve 2 has a conical hollow structure 7 extending towards the base of the cover 1 (i.e., towards the human skin) with a gradually decreasing outer diameter. The conical hollow structure 7 forms an inverted cone. When the pressure of the infusion fluid (such as saline) in the joint cavity increases during surgery and attempts to flow out from the bone tunnel opening, the fluid pressure acts directly on the outer wall of the conical hollow structure 7. According to the principles of fluid dynamics, the fluid pressure is perpendicular to the conical surface. Since the conical surface narrows downwards, the horizontal component of the fluid pressure converges from the periphery to the center, thereby generating a radial compressive stress that forces the four edges of the cross incision to interlock more tightly. The higher the infusion pressure in the joint cavity, the more intense the compression of the conical hollow structure 7 by the fluid, and the stronger the sealing performance of the sealing valve 2. This fundamentally solves the drawbacks of traditional planar valves, which are prone to flipping and leakage under high pressure, ensuring absolute clarity of the surgical field. When a surgical instrument (such as a grasping forceps or a planer) passes through the sealing valve 2, the elastic wall of the conical hollow structure 7 surrounds the outer periphery of the instrument, which not only serves as a guide, but also allows the sealing valve 2 to maintain a good sealing effect due to the long radial buffer stroke of the conical structure.

[0022] To improve the sealing effect, this embodiment provides a flexible sealing skirt 3 at the bottom edge of the cover 1. The flexible sealing skirt is existing technology and can be composed of multiple layers of elastic materials with gradually varying thicknesses. For example, in mechanical seals, industrial suction cups, diving masks, and CPAP masks, flexible materials (such as silicone or rubber) are used to create "skirts" to compensate for unevenness on the contact surface. Its core principle is to achieve airtightness by conforming to the microscopic texture under pressure. Preferably, as... Figure 4 and Figure 5As shown, the skirt adopts a stepped double-skirt structure, including an inner skirt 31 on the inside and an outer skirt 32 on the outside. The inner skirt 31 is designed to be relatively rigid and thick, and its main function is to serve as a mechanical support structure for the bottom of the cover 1, preventing the cover 1 from collapsing under strong negative pressure adsorption, while also undertaking the task of the first physical waterproofing. The outer skirt 32 is made of a soft, elastic material. Because the skin at the surgical site (such as around the patella of the knee joint) is not absolutely smooth, there are often fine skin lines, wrinkles, and even small postoperative bulges. The outer skirt 32, with its extremely high flexibility, can conform to the micro-texture of the skin under negative pressure to fill all possible air leakage gaps. Preferably, the rigidity of the inner skirt is greater than that of the outer skirt to provide mechanical support and initial waterproofing; the thickness of the outer skirt is less than that of the inner skirt to conform to the skin texture for micro-adhesive sealing. In addition, the bottom surface of the outer skirt 32 is preferably provided with a micro-suction cup array (not shown in the figure). These tiny concave structures can further increase the grip through negative pressure at the micro level when adsorbing.

[0023] This embodiment can also be improved in the following ways: 1) On the bottom surface of the base edge, a medical hydrophilic gel layer is preferably provided. The hydrophilic gel layer can effectively seal the gaps caused by skin hair or deep folds. When the negative pressure is turned on, the gel layer can quickly establish an initial seal, which greatly shortens the adsorption and fixation time of the device. At the same time, the gel layer can also alleviate the mechanical stimulation that direct adsorption of silicone may cause to the skin and reduce the risk of postoperative skin redness.

[0024] 2) In order to adapt to different anatomical positions, the shape of the base edge can be preset to be flat (for the tibial side), arc-shaped (for the condyle protrusion) or saddle-shaped (for the joint angle), thus ensuring that the device can achieve optimal fit in different patients and different bone tunnel positions.

[0025] 3) such as Figure 4 and Figure 5 As shown, radially distributed anti-collapse reinforcing ribs 6 are provided on the inner wall of the cover 1. When the attractive force is strong, the cover 1 will tend to shrink towards the center. The reinforcing ribs 6 provide the necessary radial stiffness, ensuring the stability of the internal cavity volume and preventing the inner wall of the cover from sticking to the surgical instruments and generating frictional resistance.

[0026] 4) The side wall of the lid 1 is integrally formed and has at least one handle, such as Figures 3-5 As shown, the handle 5 is an outwardly extending elastic protrusion with a ring-shaped or sheet-like structure at its end for easy finger pinching. Through the handle 5, medical staff can gently pull the edge outward and upward to facilitate the initial positioning of the sealing device and its non-destructive and rapid removal after the operation.

[0027] 5) This embodiment also includes a detachable guide rod 8. The guide rod 8 passes through the sealing valve 2, and its tip has a rounded, blunt structure without sharp edges. During installation, the doctor first inserts the guide rod 8 into the sealing cap. Since the sealing cap obstructs the view after covering the skin, the doctor can use their sense of touch to guide the tip of the guide rod 8 into the established bone tunnel (it doesn't need to be very deep). Following the guidance of the guide rod 8, the doctor presses the cap 1 against the skin surface and then applies negative pressure. Once the negative pressure is established and the device is firmly attached, the doctor pulls the guide rod 8 upwards and removes it. The guide rod 8, as an auxiliary installation tool, solves the common alignment problem of non-insertion devices. It ensures that the center of the sealing valve 2 and the opening of the bone tunnel are coaxial, greatly improving the accuracy and efficiency of the surgery. In this embodiment, the sealing device itself does not enter the bone tunnel during operation. The guide rod, as a temporary positioning element, is used for coaxial alignment during the installation phase and is removed after the seal is established.

[0028] 6) The cover 1 is also equipped with a pressure regulating mechanism, such as an overflow hole or an adjustable pressure relief valve. Considering that the pressure of the central negative pressure system in different hospitals may fluctuate, this pressure regulating mechanism allows doctors to make fine adjustments according to the situation on site. For example, when it is observed that the patient's skin is excessively bulging due to excessive negative pressure, the pressure relief valve can be finely adjusted to maintain the minimum negative pressure required for sealing and reduce skin damage.

[0029] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A water-proof device for arthroscopic access, characterized in that, Includes a cover, a sealing valve, and a negative pressure adsorption mechanism; The cover is made of elastic medical material and has a raised dome structure and a base edge located at the bottom of the dome. The sealing valve is located at the center of the cover and has a through self-sealing incision for the entry and exit of surgical instruments and to maintain airtightness. The negative pressure adsorption mechanism includes at least one negative pressure interface disposed on the cover, the negative pressure interface penetrating the cover wall and communicating with the inner cavity of the cover; in use, the negative pressure interface is used to connect an external negative pressure source to form a negative pressure sealing space between the base edge and the skin.

2. The arthroscopic access leak-proof device according to claim 1, characterized in that: The base edge is provided with a flexible sealing skirt.

3. The arthroscopic access leak-proof device according to claim 1, characterized in that: The flexible sealing skirt adopts a stepped double skirt structure, including an inner skirt located on the inside and an outer skirt located on the outside; wherein, the hardness of the inner skirt is greater than that of the outer skirt, and the thickness of the outer skirt is less than that of the inner skirt.

4. The arthroscopic access leak-proof device according to claim 1, characterized in that: At least one handle is provided on the base edge or outer peripheral sidewall of the cover.

5. The arthroscopic access leak-proof device according to claim 1, characterized in that: The negative pressure interface includes a first interface and a second interface, wherein the first interface is used to connect to a negative pressure source or a pre-stage arthroscopic access leak-proof device, and the second interface is used to connect a post-stage arthroscopic access leak-proof device in series via a connecting pipe.

6. The arthroscopic access leak-proof device according to claim 1, characterized in that: The cover is also provided with a pressure regulating mechanism, which is an overflow hole or an adjustable pressure relief valve provided on the wall of the cover.

7. The arthroscopic access leak-proof device according to claim 1, characterized in that: The sealing valve has a conical hollow structure that extends toward the base of the cover and gradually decreases in outer diameter.

8. The arthroscopic access leak-proof device according to claim 2, characterized in that: The bottom surface of the flexible sealing skirt is provided with a micro-suction cup array.

9. The arthroscopic access leak-proof device according to claim 1, characterized in that: The inner wall of the cover is provided with anti-collapse reinforcing ribs.

10. The arthroscopic access leak-proof device according to claim 1, characterized in that: It also includes a detachable guide rod that runs through the sealing valve.

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