Sealing system and single-incision approach device

Abstract

The invention discloses a sealing system and a single-incision approach device. The sealing system comprises a main sealing cover and a sealing pipe assembly communicated with the main sealing cover. The main sealing cover is made of flexible material and comprises a far-end main flange, a near-end main dome and a main shell extending between the far-end main flange and the near-end main dome. The main sealing cover is provided with two or more sets of flexible sealing pipe assemblies made of flexible materials, and any flexible sealing pipe assembly comprises a flexible sealing pipe, a flexible one-way valve, a first rigid ring and a second rigid ring. The flexible sealing pipe, the flexible one-way valve and the main dome are fixed between the first rigid ring and the second rigid ring through the first rigid ring and the second rigid ring, and airtight sealing connection is formed. The flexible sealing tube comprises an instrument sealing hole defined by the near-end membrane, and when an instrument is inserted, the instrument sealing hole and the near-end membrane can form airtight sealing. The flexible one-way valve comprises at least two valve plates; when an instrument is inserted, the valve plate can be rotationally opened; when the instrument is removed, the valve plate can be automatically restored and closed.

Description

Technical Field

[0001] The invention relates to minimally invasive surgical instruments, and in particular to a sealing system and a single-incision access device. Background Art

[0002] Laparoscopic single-port surgery is a surgical procedure that is performed through a single incision in the patient's body wall to insert and remove a laparoscope and multiple instruments. Usually, a single-incision access device is installed in the single incision as a channel for instruments to enter and exit the human body. Published in Journal of Minimal Access Surgery in 2011, number: doi: 10.4103 / 0972-9941.72360, document name: Single-incision laparoscopic surgery - current status and controversies, hereinafter referred to as document 1. Document 1 details the improvement process of the clinical application of single-incision access devices. In brief, initially three conventional puncture cannulas were inserted into a single incision to form a single incision access device (referred to as the Mickey Mouse scheme), which caused serious air leakage during surgery. This was later improved to insert an incision sleeve into the single incision, connect a soft gel platform to the outside of the incision sleeve, and puncture the soft gel platform with multiple conventional puncture cannulas to form a single incision access device (referred to as the R-Port scheme). The access platform size of this scheme was relatively large and was also prone to air leakage during surgery. The soft gel platform was then improved to connect a simplified conventional puncture cannula to the soft gel tank body to form a single incision access device (referred to as the triport scheme), which effectively solved the problem of air leakage during surgery. The Triport scheme is currently one of the most widely used single incision access devices in clinical practice. However, this scheme is limited by the conventional cannula technology formula and cannot solve two key problems in laparoscopic single-port surgery: first, the operability of any extreme angle in the hemispherical space; second, the problem of interference between multiple instruments in a very small space (referred to as the chopstick effect). Chinese invention CN110179505 discloses a highly flexible centralized single-incision access device, which adds an elastic corrugated ring to the connection area between the soft gel tank body and the puncture cannula of the single-incision access device to enhance the rotation angle of the puncture cannula, thereby increasing the flexibility of operation. This solution has a certain effect, but it still does not break through the technical framework of the triport solution and cannot solve the above two key problems. Summary of the invention

[0003] Therefore, in order to solve the problems of the prior art, the present invention proposes multiple solutions.

[0004] In one aspect of the present invention, a sealing system is proposed, comprising a main sealing cover and a sealing tube assembly connected thereto. The main sealing cover is made of a flexible material, comprising a distal main flange and a proximal main dome and a main shell extending therebetween. The main sealing cover is provided with two or more sets of flexible sealing tube assemblies made of flexible material, any of which comprises a flexible sealing tube, a flexible one-way valve, a first rigid ring and a second rigid ring; the first and second rigid rings fix the flexible sealing tube, the flexible one-way valve and the main dome therebetween to form an airtight connection. The flexible sealing tube comprises an instrument sealing hole defined by a proximal membrane, which can form an airtight seal with the instrument when the instrument is inserted; the flexible one-way valve comprises at least two valve sheets; when the instrument is inserted, the valve sheet can be rotated to open; when the instrument is removed, the valve sheet can automatically return to close.

[0005] In one solution, one or more flexible sealing tubes and the main sealing cover are integrally formed from the same material to form a single part; or one or more one-way valves and the main sealing cover are integrally formed from the same material to form a single part.

[0006] In another embodiment, the sealing tube includes a tube flange and tube through holes that are roughly evenly distributed in the circumferential direction; the one-way valve includes a valve flange and valve through holes that are roughly evenly distributed in the circumferential direction; the first rigid ring includes a first rigid ring body and rigid columns that are roughly evenly distributed along its circumferential direction; the second rigid ring includes a second rigid ring body and rigid ring fixing holes that are roughly evenly distributed along its circumferential direction; the first rigid ring body and the second rigid ring body sandwich the valve flange and the tube flange between them, so that they are stacked on each other and the rigid columns pass through the through holes and then are inserted into the rigid ring fixing holes, so that the flexible material between the first rigid ring body and the second rigid ring body is in a compressed state to form an airtight seal, and the first and second rigid ring bodies and the materials sandwiched therebetween constitute a local rigid structure.

[0007] In another embodiment, the total height of the flexible portion of the main sealing cover along the axial direction of the sealing tube assembly is H1, and the total height of the rigid portion of the local rigid structure along the axial direction of the sealing tube assembly is H2, wherein H1≥5H2.

[0008] In another embodiment, the sealing system includes four sets of sealing tube assemblies, and the lengths of the sealing tube assemblies along their tube axes are L1, L2, L3, and L4 respectively; the length difference between any two circumferentially adjacent flexible sealing tube assemblies is greater than the height H1 of the rigid part.

[0009] In another embodiment, the main sealing cover is projected from the proximal end to the distal end along the axis of the sealing tube assembly, and the projection area of ​​the maximum flexible contour is A1, and the projection area of ​​the single rigid structure is A2, wherein A1≥10A2.

[0010] In another embodiment, the flexible sealing tube comprises an instrument sealing hole with a diameter of D1 and a sealing tube wall with a diameter of D2, and a minimum inner diameter of the first and second rigid ring bodies is D3, wherein D3>D2≥3D1.

[0011] In another embodiment, the proximal membrane includes a sealing lip, and the flexible sealing tube further includes a plurality of grooves, wherein the grooves are recessed from the proximal surface of the proximal membrane to the distal surface and divide the proximal membrane into a plurality of regions; each of the grooves includes two side walls and a bottom wall; the grooves extend radially outward and penetrate the sealing tube wall, dividing the junction area between the sealing tube wall and the proximal membrane into a plurality of relatively independent convex hull areas; the side walls, bottom wall, proximal membrane and sealing tube wall are integrated into a seamless sealing membrane.

[0012] In another embodiment, the wall thickness of the proximal membrane is T1, the wall thickness of the side wall is T2, and the wall thickness of the sealing tube wall is T3, wherein 3≥2T1>2T2.

[0013] In one aspect of the present invention, a single incision access device is proposed, comprising any of the aforementioned sealing systems, and further comprising an incision sleeve, wherein the incision sleeve comprises an inner ring and an outer ring and a flexible channel connecting them, and the main flange comprises an inner ring cavity matching the shape and size of the outer ring, and the inner ring cavity is detachably connected to the outer ring and forms an airtight seal. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more fully understand the essence of the present invention, a detailed description will be given below in conjunction with the accompanying drawings, in which: Figure 1 is a three-dimensional schematic diagram of a single-incision access device 1; Figure 2 It is a three-dimensional schematic diagram of the incision sleeve 2; Figure 3 is a 3D partial cross-sectional view of the sealing system 3; Figure 4 is a projection view of the sealing system 3 from the proximal end to the distal end; Figure 5 yes Figure 4 5-5 sectional view; Figure 6 is a three-dimensional schematic diagram of the main sealing cover 4; Figure 7 is an exploded schematic diagram of the sealing tube assembly 5; Figure 8 is a three-dimensional schematic diagram of the flexible sealing tube 40a; Fig. 9 is a 3D partial cross-sectional view of the flexible sealing tube 40a; Fig.10 is a side projection view of the flexible sealing tube 40a; Fig.11 yes Fig.1011-11 sectional view; Fig.12 is a three-dimensional schematic diagram of the sealing system 3a; Fig.13 is a three-dimensional schematic diagram of the sealing system 3b; Fig.14 is a 3D partial cross-sectional view of the main sealing cover 4c; Fig.15 yes Fig.14 3D partial cross-sectional view of the inverted direction; Fig.16 is a 3D partial cross-sectional view of the main sealing cover 4d; Fig.17 is a 3D partial cross-sectional view of the main sealing cover 4e; Fig.18 is a 3D partial cross-sectional view of the sealing system 3e; Fig.19 is a side projection view of the sealing system 3e; Fig. 20 is a projection view from the proximal end to the distal end of the sealing system 3e; Throughout the several views, the same reference numerals designate identical parts or components. DETAILED DESCRIPTION

[0015] Embodiments of the present invention are disclosed herein, however, it should be understood that the disclosed embodiments are merely examples of the present invention, and the present invention can be implemented in different ways. Therefore, the contents disclosed herein are not to be interpreted as limiting, but only as a basis for the claims, and as a basis for teaching those skilled in the art how to use the present invention. The embodiments disclosed in the present invention will now be described in detail with reference to the accompanying drawings. For ease of description, the side close to the operator is defined as the proximal end, and the side away from the operator is defined as the distal end.

[0016] Figure 1 The overall composition and structure of a single incision access device 1 are described. The single incision access device 1 comprises an incision sleeve 2 and a sealing system 3. Figure 2 The incision sleeve 2 comprises an inner ring 11 and an outer ring 19 and a flexible channel 15 connecting them. Figure 3-5 The sealing system 3 includes a flexible main sealing cover 4 and a flexible sealing tube assembly 5 connected thereto.

[0017] refer to Figure 1 , Figure 3 and Figure 5The main sealing cover 4 comprises a distal main flange 21, a proximal main dome 25 and a flexible main shell 23 extending therebetween. The main flange, the main dome and the main shell together define a main cavity 24; the main flange comprises an inner ring cavity 22 matching the shape and size of the outer ring 19, and the inner ring cavity is detachably connected to the outer ring and forms an airtight seal.

[0018] like Figure 5-Figure 7 , the flexible sealing tube assembly 5 includes a flexible sealing tube 40, a flexible one-way valve 50, a first rigid ring 60 and a second rigid ring 70. The first rigid ring and the second rigid ring clamp the main dome, the flexible one-way valve and the flexible sealing tube between the two and form an airtight connection and fixation. In more detail, the flexible sealing tube 40 includes a flexible tube flange 41, a flexible proximal membrane 49 and a sealing tube wall 45 connected thereto; the tube flange 41 includes tube through holes 42 that are roughly uniformly distributed in the circumferential direction; the flexible membrane 49 includes an instrument sealing hole 48 with a diameter of D1. In a preferred embodiment, the sealing tube 40 also includes a corrugated wall 43 arranged between the sealing tube wall and the tube flange, the corrugated wall 43 includes at least one annular corrugated ring area composed of wave crests and wave troughs, and when the sealing tube rotates and swings at any angle relative to the central axis of the sealing system 3, the corrugated wall 43 is conducive to reducing its pulling force on the rigid ring fixing area.

[0019] refer to Figure 5 and Figure 7 , the flexible one-way valve 50 includes a valve flange 51, a valve sheet 59 and a valve side wall 53 connected thereto. The valve flange 51 includes valve through holes 52 that are roughly evenly distributed in the circumferential direction. The one-way valve includes at least two valve sheets 59. When an instrument is inserted through the center of the one-way valve, the valve sheet can be rotated to open; when the inserted instrument is removed, the valve sheet can automatically restore and close to prevent gas from leaking outward through the one-way valve. The first rigid ring 60 includes a first rigid ring body 61 and rigid columns 62 that are roughly evenly distributed along the circumference thereof, and the first rigid ring body defines a first center hole 64. The second rigid ring 70 includes a second rigid ring body 71 and rigid ring fixing holes 72 that are roughly evenly distributed along the circumference thereof, and the second rigid ring body defines a second center hole 74.

[0020] Continue to refer Figure 5 and Figure 7In one implementation, the main dome 35 includes a dome window 27 passing through it and dome through holes 28 that are roughly evenly distributed in the circumferential direction of the area adjacent to the window circumference. The first rigid ring body 61 and the second rigid ring body 71 sandwich the main dome 35, the valve flange 51 and the pipe flange 41 between them, so that they are stacked on each other and the rigid column passes through the dome through hole 28, the pipe through hole 42 and the valve through hole 52, and then is inserted into the rigid ring fixing hole 72 to form a tight connection, so that the flexible material between the first rigid ring body 61 and the second rigid ring body 71 is in a compressed state to form an airtight fixation. The first and second rigid ring bodies and the materials sandwiched therebetween constitute a local rigid structure.

[0021] Compared with the single incision access device of the prior art, the single incision access device 1 has the following main beneficial effects: the single incision access device 1 is an overall flexible and partially rigid structure, which is conducive to solving two key problems in laparoscopic single-port surgery. The rigid structure and flexible structure here can be understood as a flexible structure that can be deformed by the pulling or squeezing force of the surgical instrument when the instrument is moved or swung during surgery; and a rigid structure that cannot be deformed by the pulling or squeezing force of the surgical instrument.

[0022] More detailed: the distal flange, main dome, main shell, sealing tube, and one-way valve are fully flexible structures made of soft rubber materials (such as silicone, rubber, latex, etc.); the first and second rigid rings are made of engineering plastics such as polycarbonate and polypropylene, and can also be made of metal materials. The connection area between the first and second rigid rings constitutes a local rigid structure. It should be understood by those skilled in the art that the fully flexible main sealing cover can obviously achieve operability at any extreme angle in the hemispherical space. At the same time, the fully flexible main sealing cover has obvious advantages in solving the problem of mutual interference of instruments compared to the simplified rigid puncture sleeve connected to the flexible main sealing cover disclosed in the aforementioned CN110179505 (triport solution). Simulated clinical studies have shown that during single-port surgery, the instrument needs to be moved and swung at any extreme angle in the hemispherical space so that the instruments inserted into the patient's body can avoid each other; at this time, the traditional rigid puncture sleeve structure is very likely to cause mutual interference, thereby hindering the movement and swinging of the instrument. The fully flexible main sealing cover has flexible sealing tubes that can be squeezed and deformed to avoid each other without destroying the airtight state between the proximal membrane of the flexible sealing tube and the insertion instrument.

[0023] Those skilled in the art should understand that the local rigid structure can prevent the deformation from being transmitted to the valve plate of the one-way valve when the inserted instrument swings at any angle and compresses the deformation of the fully flexible main sealing cover, thereby causing leakage of the tube assembly without the instrument inserted. In particular, when the single-incision access device 1 is provided with 4 or more flexible sealing tube assemblies, instruments are inserted into 3 of the sealing tube assemblies for a long time, and instruments are inserted into the other sealing tube assemblies intermittently. For the sealing tube assembly when no instrument is inserted, the deformation blocking ability of this local rigid structure is quite important.

[0024] Continue to refer Figure 4-5 In an optimized design, the total height of the flexible part of the fully flexible main sealing cover along the axis of the flexible sealing tube assembly is H1, and the total height of the rigid part of the local rigid structure along the axis of the flexible sealing tube assembly is H2, where H1≥5H2. Simulated clinical studies have shown that this setting is conducive to better solving two key problems in laparoscopic single-port surgery.

[0025] In another optimized solution, the fully flexible main sealing cover is projected from the proximal end to the distal end along the axis of the flexible sealing tube assembly, and the projection area of ​​the maximum flexible contour is A1 (i.e. Figure 4 The projected area of ​​a single rigid structure is A2 (i.e. Figure 4 Any square filled annular area), where A1≥10A2. Simulated clinical studies have shown that this setting is conducive to better solving two key problems in laparoscopic single-port surgery.

[0026] In a typical laparoscopic single-port surgery, the single-incision access device is usually equipped with four sealing tube assemblies, the first hole is used as the endoscope operation hole, the second hole is used as the main operation hole, the third hole is used as the auxiliary operation hole, and the fourth hole is used as the intermittent use hole. Those skilled in the art should understand that the swing range of the endoscope in single-port surgery is relatively small, followed by the swing ranges of the auxiliary operation hole and the intermittent use hole, while the swing range of the main operation hole is the largest. Figure 5 In a preferred solution, the diameter D1 of the instrument sealing hole 48 of the main operation hole, the inner diameter D2 of the sealing tube wall 45, and the minimum inner diameter D3 of the first and second rigid ring bodies, wherein D3>D2≥3D1. Simulated clinical studies have shown that this setting is conducive to better solving two key problems in laparoscopic single-port surgery. The settings of the endoscopic operation hole, auxiliary operation hole, and intermittent use hole can use this diameter ratio or not.

[0027] Figure 8-11An improved flexible sealing tube 40a is described. The flexible sealing tube 40a comprises a flexible tube flange 41, a flexible proximal membrane 49a and a sealing tube wall 45a connected thereto; the tube flange 41 comprises tube through holes 42 that are substantially uniformly distributed in the circumferential direction. The sealing tube 40a further comprises a corrugated wall 43 disposed between the sealing tube wall and the tube flange, and the corrugated wall 43 comprises at least one annular corrugated ring region consisting of wave crests and wave troughs.

[0028] The proximal membrane 49a includes an instrument sealing hole 48a defined by a sealing lip 400. The flexible sealing tube 40a also includes a plurality of grooves 410. The grooves 410 are recessed from the proximal surface of the proximal membrane 49a to the distal surface and divide the proximal membrane 49a into a plurality of regions. Each of the grooves 410 includes two side walls 411 and a bottom wall 413. The side walls are gradually widened areas extending laterally outward from the sealing lip defined on both sides. The grooves 410 extend radially outward and penetrate the sealing tube wall 45a, dividing the junction area of ​​the sealing tube wall 45a and the proximal membrane 49a into a plurality of relatively independent convex hull areas 420. The side walls 411, the bottom wall 413, the proximal membrane 49a and the sealing tube wall 45a are connected as a whole to form a seamless sealing membrane.

[0029] The groove can increase the circumferential circumference, reduce the sealing wrapping area formed after the instrument is inserted, reduce the actual contact area between the instrument and the sealing film, improve lubrication reliability, increase axial tensile stiffness and other functions, thereby greatly reducing the friction resistance and reducing stick-slip, reducing the probability of the sealing film turning inward or improving the operating comfort after the sealing film turning inward; at the same time, the sealing tube wall and the proximal membrane junction area are circumferentially disconnected, which is beneficial to reducing the deformation force when the flexible sealing tube is squeezed and deformed, and at the same time, it is beneficial to reduce the pulling effect of the deformation force on the sealing lip, which is beneficial to better solve the two key problems in laparoscopic single-port surgery.

[0030] The wall thickness of the proximal membrane 49a is T1, the thickness of the side wall 411 is T2, and the wall thickness of the sealing tube wall 45a is T3. In a preferred solution, T3≥2T1>2T2. This arrangement is conducive to the sealing tube wall 45a providing sufficient axial rigidity when inserting and removing the instrument, making the instrument easy to insert; but at the same time, it can reduce the friction resistance between the instrument and the sealing lip and reduce the lateral extrusion deformation force of the sealing tube to a certain extent.

[0031] Fig.12Another improved sealing system 3a is depicted, comprising a flexible main sealing cover 4 and a flexible sealing tube assembly 5a connected thereto. The flexible sealing tube assembly 5a comprises a flexible sealing tube 40a, a flexible one-way valve 50, a first rigid ring 60 and a second rigid ring 70. The first rigid ring body 61 and the second rigid ring body 71 sandwich the main dome 25, the valve flange 51 and the pipe flange 41 therebetween, so that they are stacked on each other and the rigid column passes through the dome through hole 28, the pipe through hole 42 and the valve through hole 52, and then is inserted into the rigid ring fixing hole 72 to form a tight connection, so that the flexible material between the first rigid ring body 61 and the second rigid ring body 71 is in a compressed state to form an airtight fixation.

[0032] In a preferred solution, the sealing system 3a includes 4 identical flexible sealing tube assemblies 5a, and the flexible sealing tube assembly 5a is compatible with 5~12mm instruments. As described in Document 1, the prior art gives a simplified puncture cannula assembly to the single-hole access device, and its puncture cannula assembly usually clearly distinguishes between cannulas with a diameter of 10mm and a diameter of 5mm. During use, the instrument must strictly select a channel with a corresponding diameter specification. In particular, this type of access device usually cannot use pre-bent instruments because pre-bent instruments cannot pass through a puncture cannula with a specification of 5mm. The sealing system 3a includes 4 identical flexible sealing tube assemblies that are compatible with 5~12mm instruments. Any passage in a single-hole surgery can pass through a 12mm instrument or a pre-bent instrument, and the surgeon can flexibly and freely choose according to needs.

[0033] Fig.13 Another improved sealing system 3b is depicted, comprising a flexible sealing tube assembly 5a and a flexible sealing tube assembly 5b connected to a flexible main sealing cover 4. The flexible sealing tube assembly 5b is substantially identical to the flexible sealing tube assembly 5, except that the instrument sealing hole of the flexible sealing tube assembly 5b has a larger diameter, and can form an airtight seal with an inserted instrument with a diameter of 8 to 12 mm, but cannot form an airtight seal with an instrument with a diameter of 5 mm. In a preferred embodiment, the sealing system 3b comprises two identical flexible sealing tube assemblies 5a and two identical flexible sealing tube assemblies 5b, and the flexible sealing tube assemblies 5a and 5b are arranged at intervals.

[0034] Those skilled in the art should understand that one of the flexible sealing tube assemblies 5a is used as the main operating channel, and the other flexible sealing tube assembly 5a is used as the auxiliary operating channel, and both can use pre-bent instruments; 8~12mm instruments can also be used when necessary. One of the flexible sealing tube assemblies 5b can be used as an endoscope channel, and the other flexible sealing tube assembly 5b can be used as an intermittent hole. The sealing system 3b is suitable for single-port cholecystectomy, single-port appendectomy, single-port gynecological surgery and other surgeries that use pre-bent instruments to avoid instrument interference (i.e., chopstick effect); situations where gauze needs to be frequently inserted and removed for hemostasis, closing clamps are applied, and fragmented tissues are removed. The application of the sealing system 3b can greatly improve the operability of instruments during surgery, reduce the switching of instruments, and improve surgical efficiency.

[0035] Figure 14-15 A further improved main sealing cover 4c is depicted, comprising a distal main flange 21 and a proximal main dome 25c and extending to a flexible main shell 23 therebetween. The main flange, the main dome and the flexible main shell together define a main cavity 24; the main flange comprises an inner ring cavity 22 matching the shape and size of the outer ring 19. The main dome 25c comprises a plurality of flexible one-way valves 50c recessed from the proximal end into the main cavity 24. The one-way valve 50c comprises a flexible valve flange 51c, a valve sheet 59c and a valve side wall 53c connected thereto. The valve flange 51c comprises valve through holes 52c that are substantially uniformly distributed in the circumferential direction. The one-way valve comprises at least two valve sheets 59c. When an instrument is inserted through the center of the one-way valve, the valve sheet can be rotated to open; when the inserted instrument is removed, the valve sheet can automatically return to close to prevent gas from leaking outward through the one-way valve.

[0036] The flexible main sealing cover 4 and the one-way valve 50 in the sealing system 3 are replaced by the main sealing cover 4c to form a new sealing system 3c (not shown in the figure). It should be easy for those skilled in the art to understand that the sealing system 3c is basically the same as the sealing system 3. The main difference is that the main sealing cover 4c and the one-way valve 50c are integrally formed to form a single part, which is conducive to reducing the overall parts manufacturing cost and reducing assembly links.

[0037] Fig.16 A further improved main sealing cover 4d is depicted, comprising a distal main flange 21 and a proximal main dome 25d and extending to a flexible main shell 23 therebetween. The main flange, the main dome and the flexible main shell together define a main cavity 24. The main flange comprises an inner ring cavity 22 matching the shape and size of the outer ring 19. The main dome 25d comprises a plurality of flexible sealing tubes 40d protruding proximally from the main cavity 24. The flexible sealing tubes 40d comprise a flexible tube flange 41d, a flexible proximal membrane 49d and a sealing tube wall 45d connected thereto; the tube flange 41d comprises tube through holes 42d substantially uniformly distributed in the circumferential direction; and the flexible membrane 49d comprises an instrument sealing hole 48d having a diameter D1.

[0038] The flexible main sealing cover 4 and the flexible sealing tube 40 in the sealing system 3 are replaced by the main sealing cover 4d to form a new sealing system 3d (not shown in the figure). It should be easy for those skilled in the art to understand that the sealing system 3d is basically the same as the sealing system 3. The main difference is that the main sealing cover 4d and the flexible sealing tube 40d are integrally formed to form a single part, which is conducive to reducing the overall parts manufacturing cost and reducing assembly links.

[0039] Fig.17 A further improved main sealing cover 4e is depicted, comprising a distal main flange 21 and a proximal main dome 25e and extending to a flexible main shell 23 therebetween. The main flange, the main dome and the flexible main shell together define a main cavity 24. The main flange comprises an inner annular cavity 22 matching the shape and size of the outer ring 19. The main dome 25e comprises a plurality of flexible sealing tubes 40e protruding proximally from the main cavity 24. The flexible sealing tube 40e comprises a sealing tube wall 45e, a proximal membrane 49e and a flange 41e disposed therebetween. The flange 41e comprises tube through holes 42e that are substantially uniformly distributed in the circumferential direction. The proximal membrane 49e comprises an instrument sealing hole 48e having a diameter D1.

[0040] The main sealing cover 4e is similar to the main sealing cover 4d, and the main difference is that the flange position of the flexible sealing pipe is different. The main sealing cover 4e replaces the main sealing cover 4d of the sealing system 3d to form a new sealing system 3e (such as Fig.18 As shown). The first and second rigid rings sandwich the flexible sealing pipe point flange 41e and the one-way valve flange 51 between the two, so that they are stacked on each other and the rigid column passes through the pipe through hole 42e and the valve through hole 52, and then is inserted into the rigid ring fixing hole 72 to form a tight connection, so that the flexible material between the first rigid ring body 61 and the second rigid ring body 71 is in a compressed state to form an airtight fixation, forming a flexible sealing pipe assembly 5e. The first and second rigid ring bodies and the materials sandwiched therebetween constitute a local rigid structure, and the rigid part height of the local rigid structure along the axis direction of the flexible sealing pipe assembly is L0.

[0041] In an optional solution, the flexible sealing tube assembly 5e includes a flexible sealing tube assembly 51e with a length of L1, a flexible sealing tube assembly 52e with a length of L2, a flexible sealing tube assembly 53e with a length of L3, and a flexible sealing tube assembly 54e with a length of L4. The length of the flexible sealing tube assembly is measured as the shortest distance between the main dome 25e and the proximal end of the rigid ring body along the tube axis (e.g. Fig.19 In a preferred embodiment, the length difference between any two circumferentially adjacent flexible sealing tube components 53e is greater than the height L0 of the rigid portion. Figure 19-20, for example, L2-L1>L0, L3-L2>L0, L3-L4>L0, L4-L1>L0. Those skilled in the art should understand that this arrangement can maximize the swing range of the flexible pipe assembly as much as possible, thereby ensuring the reliability of the seal and avoiding mutual interference between local rigid parts.

[0042] Those skilled in the art should be able to understand that the technical features disclosed in various examples of the present invention can be combined with each other, such as a combination of several flexible sealing tubes, a flexible one-way valve, a first rigid ring and a second rigid ring. The examples describe different features using first, second, third, fourth, etc., but they cannot be understood as restrictions on the order of precedence. The circles, rings, etc. in the examples cannot be limited to perfect circles, and the approximate circles formed by ellipses or closed polygons do not deviate from the concept of the present invention. Many different embodiments and examples of the present invention have been shown and described.

[0043] A person of ordinary skill in the art can make adaptive improvements to the method and apparatus by appropriate modifications without departing from the scope of the invention. For example, changing the radius of the fillet, adding a process cavity, changing a plane to a curved surface, and adding reinforcing ribs. As long as these modifications are still basically the same as the idea of ​​the invention when viewed from an overall perspective, they still fall within the scope of protection of the invention. Many different embodiments and examples of the invention have been shown and described. A person of ordinary skill in the art can make adaptive improvements to the method and apparatus by appropriate modifications without departing from the scope of the invention. Several modifications have been mentioned, and other modifications are conceivable to a person of ordinary skill in the art. Therefore, the scope of the invention should be in accordance with the appended claims, and should not be understood as being limited by the specific contents of the structures, materials or behaviors shown and recorded in the specification and drawings.

Claims

1. A sealing system, comprising a main sealing cover and a sealing tube assembly connected thereto, characterized in that: 1) The main sealing cover is made of a flexible material, and comprises a distal main flange, a proximal main dome and a main shell extending therebetween; 2) The main sealing cover is provided with two or more sets of flexible sealing tube assemblies made of flexible materials, any of which comprises a flexible sealing tube, a flexible one-way valve, a first rigid ring and a second rigid ring; the first rigid ring and the second rigid ring fix the flexible sealing tube, the flexible one-way valve and the main dome therebetween to form an airtight connection; 3) The flexible sealing tube includes an instrument sealing hole defined by a proximal membrane, which can form an airtight seal with the instrument when it is inserted; the flexible one-way valve includes at least two valve sheets; when the instrument is inserted, the valve sheet can be rotated to open; when the instrument is removed, the valve sheet can automatically restore to close.

2. The sealing system according to claim 1, characterized in that: One or more flexible sealing tubes and the main sealing cover are integrally formed from the same material to form a single part; or one or more one-way valves and the main sealing cover are integrally formed from the same material to form a single part.

3. The sealing system according to claim 1, characterized in that: The sealing tube includes a tube flange and tube through holes that are roughly evenly distributed in the circumferential direction; the one-way valve includes a valve flange and valve through holes that are roughly evenly distributed in the circumferential direction; the first rigid ring includes a first rigid ring body and rigid columns that are evenly distributed along the circumferential direction; the second rigid ring includes a second rigid ring body and rigid ring fixing holes that are evenly distributed along the circumferential direction; the first rigid ring body and the second rigid ring body sandwich the valve flange and the tube flange between them, so that they are stacked on each other and the rigid columns pass through the through holes and then are inserted into the rigid ring fixing holes, so that the flexible material between the first rigid ring body and the second rigid ring body is in a compressed state to form an airtight seal, and the first and second rigid ring bodies and the materials sandwiched therebetween constitute a local rigid structure.

4. The sealing system according to claim 3, characterized in that: The total height of the flexible part of the main sealing cover along the axial direction of the sealing tube assembly is H1, and the total height of the rigid part of the local rigid structure along the axial direction of the sealing tube assembly is H2, wherein H1≥5H2.

5. The sealing system according to claim 4, characterized in that The sealing system comprises four sets of sealing tube assemblies, and the lengths of the sealing tube assemblies along their tube axes are L1, L2, L3, and L4 respectively; the length difference between any two circumferentially adjacent flexible sealing tube assemblies is greater than the height H1 of the rigid part.

6. The sealing system according to claim 3, characterized in that: The main sealing cover is projected from the proximal end to the distal end along the axis of the sealing tube assembly, and the projection area of ​​the maximum flexible contour is A1, and the projection area of ​​the single rigid structure is A2, wherein A1≥10A2.

7. The sealing system according to claim 6, characterized in that: The flexible sealing tube comprises an instrument sealing hole with a diameter of D1 and a sealing tube wall with a diameter of D2, and a minimum inner diameter D3 of the first and second rigid ring bodies, wherein D3>D2≥3D1.

8. The sealing system according to claim 6, characterized in that: The proximal membrane includes a sealing lip, and the flexible sealing tube also includes a plurality of grooves, which are recessed from the proximal surface of the proximal membrane to the distal surface and divide the proximal membrane into a plurality of areas; each of the grooves includes two side walls and a bottom wall; the grooves extend radially outward and penetrate the sealing tube wall, dividing the junction area between the sealing tube wall and the proximal membrane into a plurality of relatively independent convex hull areas; the side walls, bottom wall, proximal membrane and sealing tube wall are connected as a whole to form a seamless sealing membrane.

9. The sealing system according to claim 6, characterized in that: The wall thickness of the proximal membrane is T1, the side wall thickness of the proximal membrane is T2, and the wall thickness of the sealing tube wall is T3, wherein 3≥2T1>2T2.

10. A single incision access device comprises any sealing system as claimed in claims 1-9, and further comprises an incision sleeve, wherein the incision sleeve comprises an inner ring and an outer ring and a flexible channel connecting them, the main flange comprises an inner ring cavity matching the shape and size of the outer ring, the inner ring cavity is detachably connected to the outer ring and forms an airtight seal.

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