Main sealing cover of single-incision approach device, sealing system and approach device

Abstract

The invention discloses a main sealing cover of a single-incision approach device, a sealing system and the approach device. The main sealing cover 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 flange, the main dome, and the main housing together define a main cavity. The primary seal cover also includes a plurality of pleat regions, any pleat region including a plurality of pleats, each pleat including a pleat peak, a pleat valley, and a pleat wall extending therebetween. The wrinkle area transversely extends towards the center of the dome from an area close to the intersection of the main shell and the dome; and the main dome is divided into three or more than three dome areas. Any of the dome regions includes a nozzle extending through the main dome and toward the proximal end. And the main sealing cover is inflated, and the wrinkles of the wrinkled area expand, so that the dome area and the pipe opening deflect in the direction away from the center.

Description

Technical Field

[0001] The invention relates to a minimally invasive surgical instrument, and in particular to a main sealing cover, a sealing system and an access device of 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 main sealing cover of a single-incision access device is provided, comprising a distal main flange and a proximal main dome and a main shell extending therebetween; the main flange, the main dome and the main shell together define a main cavity. The main sealing cover also comprises a plurality of fold areas, any fold area comprises a plurality of folds, each fold comprises a fold peak, a fold valley and a fold wall extending therebetween. The fold area starts from the vicinity of the intersection of the main shell and the dome and extends laterally toward the center of the dome; and the main dome is divided into three or more dome areas. Any dome area comprises a tube opening that penetrates the main dome and extends toward the proximal end.

[0005] In one solution, the fold area includes a first fold area and a second fold area; the first and second fold areas divide the main dome into a first dome area, a second dome area and a third dome area.

[0006] In another embodiment, the main sealing cover further includes a central annular shell, the central annular shell includes a central revolving wall with a substantially uniform wall thickness and intersecting with the first pleated zone and the second pleated zone at the same time; the central revolving wall simultaneously extends and intersects with the pleated peaks, pleated walls, and pleated valleys to form a partially closed wave lip structure, and constitutes a seamless membrane structure. The central revolving wall defines a central hollow cavity. The first and second pleated zones are outside the central cavity. In another optional embodiment, the inner side of the central hollow cavity includes a central pleated zone. The central pleated zone includes a plurality of annular pleats, each of which includes a pleated peak, a pleated valley, and a pleated wall extending therebetween.

[0007] In another embodiment, the main sealing cover includes a first nozzle, a second nozzle and a third nozzle that penetrate the main dome and extend toward the proximal end; the fold area includes a first segmentation fold, a second segmentation fold and a third segmentation fold. The first segmentation fold starts from the vicinity of the intersection of the main shell and the main dome on the left side of the first nozzle, first extends laterally inward toward the center of the main sealing cover, then turns back and extends laterally outward (toward away from the center) to the vicinity of the intersection of the main shell and the main dome on the right side of the first nozzle, defining the first dome area. The second segmentation fold starts from the vicinity of the intersection of the main shell and the main dome on the left side of the second nozzle, first extends laterally inward toward the center of the main sealing cover, then turns back and extends laterally outward (toward away from the center) to the vicinity of the intersection of the main shell and the main dome on the right side of the second nozzle, defining the second dome area. The third segmented fold starts from the vicinity of the intersection of the main shell and the main dome on the left side of the third pipe outlet, first extends laterally inward toward the center of the main sealing cover, and then turns back and extends laterally outward (towards away from the center) to the vicinity of the intersection of the main shell and the main dome on the right side of the third pipe outlet, thereby defining the third dome area.

[0008] In another embodiment, the main sealing cover includes a first nozzle, a second nozzle and a third nozzle that penetrate the main dome and extend toward the proximal end; the fold area includes a first segmentation fold, a second segmentation fold and a third segmentation fold. The first segmentation fold starts from the vicinity of the intersection of the main shell and the main dome on the left side of the first nozzle, and extends circumferentially around the first nozzle to the vicinity of the intersection of the main shell and the main dome on the right side thereof, thereby defining the first dome area. The second segmentation fold starts from the vicinity of the intersection of the main shell and the main dome on the left side of the second nozzle, and extends circumferentially around the second nozzle to the vicinity of the intersection of the main shell and the main dome on the right side thereof, thereby defining the second dome area. The third segmentation fold starts from the vicinity of the intersection of the main shell and the main dome on the left side of the first nozzle, and extends circumferentially around the third nozzle to the vicinity of the intersection of the main shell and the main dome on the right side thereof, thereby defining the third dome area. In an optional solution, a region where the first pipe opening is at the shortest distance from the main shell is provided with transverse ribs extending laterally and connecting a plurality of pleated walls, and the transverse ribs can prevent the pleats in the adjacent region from stretching and deforming.

[0009] In another embodiment, the main sealing cover includes a main axis, the nozzle includes a tube axis, and the main sealing cover includes two states: an initial state and a gas-deformed state. In the initial state, the main axis and the tube axis are substantially parallel. In the gas-deformed state, when all openings on the main sealing cover are sealed to form an airtight condition, gas is injected into the main cavity and a gas pressure of 2000±300 Pascal is maintained, the fold area is stretched and deformed, and the dome area and the nozzle are turned or deflected in a direction away from the center of the main sealing cover, and the first axis and the main axis form an angle A. In a specific embodiment, 15°≤A<90°.

[0010] In another embodiment, the folds have a V-shaped cross section or a U-shaped cross section, or one portion is V-shaped and the other portion is U-shaped.

[0011] In another aspect of the present invention, a main sealing system is proposed, comprising any of the aforementioned main sealing covers, and also comprising a sealing tube assembly, wherein the sealing tube assembly comprises a sealing membrane, a one-way valve, a first rigid ring and a second rigid ring; the sealing membrane and the one-way valve are clamped between the first rigid ring and the second rigid ring in a compressed state to form an airtight seal; the sealing tube assembly is connected to the pipe opening of the main sealing cover.

[0012] In another aspect of the present invention, a single incision access device is proposed, wherein the main sealing system 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 concave annular cavity matching the shape and size of the outer ring, wherein the inner concave annular cavity is detachably connected to the outer ring and forms an airtight seal.

[0013] When the single-incision access device is in clinical working conditions (or the main flange is closed to form an airtight condition), gas is injected into the sealing system 3d and the air pressure is maintained at 2000±300 Pascals, and the first, second, and third folds are stretched and deformed. The first, second, and third folds are asymmetrically arranged relative to their tube openings, and the folds toward the central area of ​​the main sealing cover have a greater degree of freedom, while the folds adjacent to the main shell have a smaller degree of freedom; therefore, under the action of air pressure, the first dome area and the first tube opening are turned over or deflected in a direction away from the center of the main sealing cover; the second dome area and the second tube opening are turned over or deflected in a direction away from the center of the main sealing cover; and the third dome area and the third tube opening are turned over or deflected in a direction away from the center of the main sealing cover. 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 It is a projection view of the single-incision approach device from the proximal end to the distal end; Figure 4 yes Figure 3 4-4 sectional view; Figure 5 is an exploded schematic diagram of the sealing tube assembly 5; Figure 6 is a three-dimensional schematic diagram of the main sealing cover 4; Figure 7 is a 3D partial cross-sectional view of the main sealing cover 4; Figure 8 is a three-dimensional schematic diagram of the main sealing cover 4a; Fig. 9 is a 3D partial cross-sectional view of the main sealing cover 4a; Fig.10 is a projection view of the main sealing cover 4a from the proximal end to the distal end; Fig.11 yes Fig.10 11-11 sectional view; Fig.12 is a three-dimensional schematic diagram of the main sealing cover 4b; Fig.13 is a 3D partial cross-sectional view of the main sealing cover 4b; Fig.14 is a three-dimensional schematic diagram of the main sealing cover 4c; Fig.15 is a 3D partial cross-sectional view of the main sealing cover 4c; Fig.16 is a side projection view of the main sealing cover 4c; Fig.17 yes Fig.16 17-17 sectional view; Fig.18 is a three-dimensional schematic diagram of the main sealing cover 4d; Fig.19 is a 3D partial cross-sectional view of the main sealing cover 4d; Fig. 20 is a side projection view of the main sealing cover 4d; Fig.21 yes Fig. 20 21-21 sectional view; Fig. 22 is an exploded schematic diagram of the sealing tube assembly 500; Fig.23 is a projection view of the sealing system 3e from the proximal end to the distal end; Fig.24 yes Fig.23 24-24 sectional view; 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 sealing tube assembly 5 connected to a main sealing cover 4.

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

[0018] like Figure 4-5 , the sealing tube assembly 5 comprises a sealing membrane 40, a one-way valve 50, a sleeve cover 60 and a sleeve shell 70. The sealing membrane 40 comprises a proximal membrane flange 41, a distal membrane sealing lip 49 and a membrane wall 45 extending therebetween. The one-way valve 50 comprises a proximal valve flange 51, a valve plate 59 and a valve side wall 55 connected thereto. The one-way valve comprises at least two valve plates 59. When an instrument is inserted through the center of the one-way valve, the valve plate can be rotated to open; when the inserted instrument is removed, the valve plate can automatically restore and close to prevent gas from leaking outward through the one-way valve. The sleeve cover 60 comprises a proximal cover top 61 and a cover flange 69 connected thereto and extending to the distal end, and a cover center hole 65 penetrates the sleeve cover from the proximal end to the distal end. The sleeve shell 70 comprises a proximal shell flange 71, a distal shell mouth 79 and a sleeve shell wall 75 extending therebetween; the sleeve center hole 72 penetrates the sleeve shell 70 from the proximal end to the distal end. The membrane flange 41 and the valve flange 51 are sandwiched between the cover flange 69 and the shell flange 71 and are in a compressed state to form an airtight seal. The sleeve cover and the sleeve shell can be fixed by interference fit, snap connection, glue bonding and other fixing methods.

[0019] Continue to refer Figure 3-Figure 4 The main sealing cover 4 also includes a plurality of nozzles 27 that penetrate the main dome 25 and extend toward the proximal end. In this example, three nozzles 27 are included, and the number of nozzles can be increased or decreased as needed. The distal shell nozzle 79 of the sealing tube assembly 5 is inserted into the nozzle 27 to form a reliable airtight connection. In order to ensure the reliability of the connection, a protrusion (undercut) or glue bonding can be added at the distal shell nozzle.

[0020] Combination Figure 1 , the single-incision access device 1 of this example protects three sealing tube assemblies. When the device 1 is used for laparoscopic single-port surgery, the inner ring of the incision sleeve is inserted into the patient's body, the flexible channel is close to the patient's incision, and the outer ring is left outside the body and connected to the concave ring cavity 22 of the sealing system 3 to form an airtight seal. A reliable airtight seal is formed between the various components of the sealing system 3, and the sealing device 3 usually also includes a trachea 9. During laparoscopic single-port surgery, CO2 gas is continuously input into the patient's body through the trachea, and the air pressure is maintained at 2000±300 Pascals. When the instrument is not inserted, the valve sheet of the one-way valve can automatically restore and close to prevent gas from leaking outward through the one-way valve. When the instrument is inserted, the membrane sealing lip 49 wraps the instrument to form an airtight seal. Usually, the first sealing tube assembly is used as the endoscope channel, the second sealing tube assembly is used as the main operation channel, and the third sealing tube assembly is used as the auxiliary operation channel. Depending on the complexity of the operation, more sealing tube assemblies can also be added.

[0021] Reference Figure 3 , Figure 4 , Figure 6 and Figure 7In an optimized solution, the main sealing cover 4 further comprises a first fold area 80 and a second fold area 90. The first fold area 80 comprises a plurality of first folds, wherein the first folds comprise a first fold peak 81, a first fold valley 83 and a first fold wall 82 extending therebetween. The second fold area 90 comprises a plurality of second folds, wherein the second folds comprise a second fold peak 91, a second fold valley 93 and a second fold wall 92 extending therebetween.

[0022] The first fold area and the second fold area start from the adjacent area where the main shell and the dome meet, and extend laterally toward the center of the dome; the first and second fold areas divide the dome into a first dome area 25a, a second dome area 25b and a third dome area 25c. The first dome area 25a includes a first pipe opening 27a and a first axis 271a; the second dome area 25b includes a second pipe opening 27b and a second axis 271b; the third dome area 25c includes a third pipe opening 27c and a third axis 271c.

[0023] In a typical design, the main sealing cover 4 includes two states: an initial state and a gas-deformed state. In the initial state, the main axis 8 of the main sealing cover is substantially parallel to the first axis 271a, the second axis 271b, and the third axis 271c.

[0024] Gas deformation state (combined Figure 4 and Figure 7 Understanding): When the single-incision access device 1 is in clinical working conditions (or the main flange 21 is closed to form an airtight condition), gas is injected into the sealing system 3 and the air pressure of 2000±300 Pa is maintained, the first fold area and the second fold area are stretched and deformed, so that the first dome area and the first nozzle are flipped or deflected in the direction away from the center of the main sealing cover (reference shear head direction), and the first axis and the main axis form an angle A1. Similarly, the second dome area and the second nozzle are flipped or deflected in the direction away from the center of the main sealing cover, and the second axis and the main axis form an angle A2; the third dome area and the third nozzle are flipped or deflected in the direction away from the center of the main sealing cover, and the third axis and the main axis form an angle A3. More vividly, the main sealing cover 4 in the gas-deformed state forms a tree-like structure: the main shell forms a hollow trunk, and the deflected nozzle and the sealing tube assembly form a hollow branch connected to the hollow trunk. Such a hollow tree-like structure in the non-deformed state (initial state) is difficult to manufacture or is very expensive to manufacture.

[0025] The aforementioned single-incision access device with a hollow tree-like structure in a gas-deformed form has the following main beneficial effects: the single-incision access device 1 is conducive to solving two key problems in laparoscopic single-port surgery. In the gas-deformed state, the fold area produces a stretching deformation, so that the first (second, third) dome area and the first (second, third) tube opening are flipped or deflected in a direction away from the center of the main sealing cover, so that the sealing tube assemblies connected to the first (second, third) tube openings are separated from each other. Those skilled in the art should be able to understand that the single incision size of laparoscopic single-port surgery is usually 20~30mm, and the diameter of the incision sleeve built into the patient's incision is usually 50~80mm. Keeping the proximal ends of the sealing tube assemblies as far away from each other as possible under the condition of maintaining a small-sized channel, that is, making the fulcrums of the surgical instruments separated from each other, can effectively solve the problem of mutual interference of instruments (chopstick effect). This fulcrum separation cannot be achieved by increasing the length of the sealing tube assembly, because this requires increasing the length of the operating instrument and increases the difficulty of operation to a certain extent. The sealing tube components in the aforementioned gas-varied form are separated from each other, providing operating fulcrums that are as far away from each other as possible within the limited size; since such operating fulcrums that are separated from each other are achieved by the folds stretching under gas pressure, they do not affect the flexibility of movement and swinging in the hemispherical space. When the device is static, operating fulcrums that are as far away from each other as possible are provided; when the device is moving, the folds deformed under gas pressure can be rotated or deflected at will. The aforementioned fold area segmentation effect causes the segmented dome area and the pipe opening connected thereto to flip or deflect in a direction away from the center of the main sealing cover, so it can be figuratively called an eccentric fold.

[0026] In a preferred design, the size and shape of the first and second pleats are designed so that when they are stretched and deformed in the pneumatic state, the angles formed are: 15°≤A1<90°, 15°≤A2<90°, 15°≤A3<90°.

[0027] Figure 8-11 A further improved main seal 4a is depicted. The main seal 4a comprises a main flange 21 and a main dome 25 and extends to a main housing 23 therebetween. The flange, dome and main housing together define a main cavity 24; the flange comprises an inner concave annular cavity 22 which matches the outer ring 19.

[0028] The primary sealing cover 4a further comprises a first pleated area 180 and a second pleated area 190. The first pleated area 180 comprises a plurality of first pleats, wherein the first pleats comprise pleat peaks 181, pleat valleys 183 and pleat walls 182 extending therebetween. The second pleated area 190 comprises a plurality of second pleats, wherein the second pleats comprise pleat peaks 191, pleat valleys 193 and pleat walls 192 extending therebetween.

[0029] The first fold area and the second fold area start from the adjacent area where the main shell and the dome meet, and extend laterally toward the center of the dome. The first and second fold areas divide the dome into a first dome area 25a, a second dome area 25b, a third dome area 25c and a fourth dome area 25d. The first dome area 25a includes a first pipe opening 27a and a first axis 271a; the second dome area 25b includes a second pipe opening 27b and a second axis 271b; the third dome area 25c includes a third pipe opening 27c and a third axis 271c; the fourth dome area 25d includes a fourth pipe opening 27d and a fourth axis 271d.

[0030] In a preferred embodiment, the main sealing cover 4a further comprises a central ring shell 100, wherein the central ring shell 100 comprises a central rotating wall 101 having a substantially uniform wall thickness and intersecting with the first fold area 180 and the second fold area 190 at the same time. Fig. 9 and Fig.11 It is understood that the central revolving wall 101 extends and intersects with the fold peak 181, the fold wall 182, the fold valley 183, the fold peak 191, the fold wall 192 and the fold valley 193 at the same time, forming a seamless film-like structure. The central revolving wall 101 extends and intersects with the first and second fold areas to form a partially closed wave lip structure 103. The central revolving wall 101 defines a central hollow cavity 105. The first and second fold areas are outside the central cavity 105.

[0031] The main sealing cover 4 a replaces the main sealing cover 4 to form a new sealing system 3 a (not shown in the figure). The main sealing cover 4 a has similar beneficial effects as the main sealing cover 4 .

[0032] That is, the main sealing cover 4a includes two states: an initial state and a gas-deformed state. In the initial state, the main axis 8 of the main sealing cover is substantially parallel to the first axis 271a, the second axis 271b, the third axis 271c, and the fourth axis 271d.

[0033] Gas deformation state: When the single-incision access device is in clinical working conditions (or the main flange 21 is closed to form an airtight condition), gas is injected into the sealing system 3a and the gas pressure is maintained at 2000±300 Pa, the first fold area and the second fold area are stretched and deformed, so that the first dome area and the first pipe opening are turned or deflected in a direction away from the center of the main sealing cover, and the first axis and the main axis form an angle A1. The second dome area and the second pipe opening are turned or deflected in a direction away from the center of the main sealing cover, and the second axis and the main axis form an angle A2; the third dome area and the third pipe opening are turned or deflected in a direction away from the center of the main sealing cover, and the third axis and the main axis form an angle A3. The fourth dome area and the fourth pipe opening are turned or deflected in a direction away from the center of the main sealing cover, and the fourth axis and the main axis form an angle A4. In a preferred design scheme, the size and shape of the first and second pleats are designed so that when they are stretched and deformed in the gas-variable state, the angles formed are: 15°≤A1<90°, 15°≤A2<90°, 15°≤A3<90°, 15°≤A4<90°.

[0034] The main sealing cover 4a has a similar design concept to the main sealing cover 4. However, the cross section of the folds of the main sealing cover 4a is U-shaped, and under the same design size, its deformable range is larger. When the center of the main sealing cover 4a includes a central ring shell 100, the first fold and the second fold thereof can be deformed in a larger range by turning or deflecting from the center to the outside.

[0035] Figure 12-13 Another improved main seal cover 4b is depicted. The main seal cover 4b is substantially the same as the main seal cover 4a, and the difference mainly lies in the arrangement of the central ring shell. Briefly, the main seal cover 4b comprises a main flange 21, a main dome 25, a main shell 23, a first folded area 180 and a second folded area 190. The first and second folded areas divide the dome into first, second, third and fourth dome areas.

[0036] The main sealing cover 4b further includes a central annular shell 100b, wherein the central annular shell 100b includes a central revolving wall 101 having a substantially uniform wall thickness and intersecting the first fold area 180 and the second fold area 190 at the same time. Fig. 9 and Fig.11It is understood that the central revolution wall 101 extends and intersects with the fold peak 181, the fold wall 182, the fold valley 183, the fold peak 191, the fold wall 192 and the fold valley 193 at the same time, forming a seamless membrane structure. The central revolution wall 101 extends and intersects with the first and second fold areas to form a partially closed wave lip structure 103. The central revolution wall 101 defines a central hollow cavity 105. The first and second fold areas are outside the central cavity 105. The central hollow cavity 105 includes a central fold area 110 inside. The central fold area 110 includes a plurality of annular folds, each of which includes a fold peak 111, a fold valley 113 and a fold wall 112 extending therebetween.

[0037] That is, the main sealing cover 4b is similar in design concept to the main sealing cover 4a, and also includes two states: an initial state and a gas-deformed state. Since the central ring shell 100b of the main sealing cover 4b includes a central annular folded area 110, under the same design size, its deformable range is larger.

[0038] Figure 14-17 A further improved main seal cover 4c is depicted. The main seal cover 4c comprises a distal flexible main flange 21 and a proximal flexible 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 concave annular cavity 22 matching the outer ring 19.

[0039] The main sealing cover 4c includes a first pipe opening 27a and a first axis 271a, a second pipe opening 27b and a second axis 271b, a third pipe opening 27c and a third axis 271c, and a first segmentation pleat 210, a second segmentation pleat 220 and a third segmentation pleat 230, which are disposed in and penetrate the main dome 25.

[0040] In an optional design, the first dividing fold 210 starts from the vicinity of the intersection of the main shell and the main dome on the left side of the first pipe opening 27a, and first extends laterally inward toward the center of the main sealing cover; then turns back and extends laterally outward (toward away from the center) to the vicinity of the intersection of the main shell and the main dome on the right side of the first pipe opening 27a; thereby defining the first dome area 25a. The first dividing fold 210 includes a plurality of first folds, and the first folds include fold peaks 211, fold valleys 213 and fold walls 212 extending therebetween. The folds of the first dividing fold 210 "divide" the first dome area 25a from the main dome 25. The so-called "division" is not a real cut, but a Figure 16-17 As shown in the cross-section, the first dome area 25a is separated from the main dome 25, and as viewed from an overall perspective, the first dome area 25a is connected to the side of the fold to form a complete seamless membrane structure.

[0041] Similarly, the second segmented fold 220 starts from the vicinity of the intersection of the main shell and the main dome on the left side of the second pipe opening 27b, first extends laterally inward toward the center of the main sealing cover, then turns back and extends laterally outward (toward away from the center) to the vicinity of the intersection of the main shell and the main dome on the right side of the second pipe opening 27b, thereby defining the second dome area 25b. The second segmented fold 220 includes a plurality of second folds, each of which includes a fold peak 221, a fold valley 223, and a fold wall 222 extending therebetween.

[0042] Similarly, the third segmented fold 230 starts from the vicinity of the intersection of the main shell and the main dome on the left side of the third pipe opening 27c, first extends laterally inward toward the center of the main sealing cover, then turns back and extends laterally outward (toward away from the center) to the vicinity of the intersection of the main shell and the main dome on the right side of the third pipe opening 27c, thereby defining the third dome area 25c. The third segmented fold 230 includes a plurality of third folds, each of which includes a fold peak 231, a fold valley 233, and a fold wall 232 extending therebetween.

[0043] The main sealing cover 4c replaces the main sealing cover 4 to form a new sealing system 3c (not shown in the figure), and the main sealing cover 4c has similar beneficial effects as the main sealing cover 4. That is, the main sealing cover 4c includes two states: an initial state and a gas-deformed state. In the initial state, the main axis 8 of the main sealing cover is substantially parallel to the first axis 271a, the second axis 271b, and the third axis 271c.

[0044] Gas deformation state: When the single-incision access device is in clinical working conditions (or the main flange 21 is closed to form an airtight condition), gas is injected into the sealing system 3c and the gas pressure of 2000±300 Pa is maintained, and the first, second, and third segmented folds are stretched and deformed, so that the first dome area and the first pipe opening are turned or deflected in a direction away from the center of the main sealing cover, and the first axis and the main axis form an angle A1. The second dome area and the second pipe opening are turned or deflected in a direction away from the center of the main sealing cover, and the second axis and the main axis form an angle A2; the third dome area and the third pipe opening are turned or deflected in a direction away from the center of the main sealing cover, and the third axis and the main axis form an angle A3. In a preferred design scheme, the structure and size of the first, second, and third segmented folds are designed so that when they are stretched and deformed in the gas-deformed state, the angles formed are: 15°≤A1<90°, 15°≤A2<90°, and 15°≤A3<90°.

[0045] The main sealing cover 4c has a similar design concept to the main sealing cover 4. However, the cross section of the folds of the main sealing cover 4c is U-shaped, and the stretching and deformation of the divided folds are easier. Under the same design size, the deformation range is larger.

[0046] Figure 14-17 The structures and sizes of the first, second and third segmented folds are substantially the same, and the first, second and third segmented folds are not intersecting and connected to each other. It should be easy for a person skilled in the art to understand that the structures and sizes of the first, second and third segmented folds can be designed to be different, or they can be partially intersecting with each other.

[0047] Figure 18-Figure 21 A further improved main seal cover 4d is depicted. The main seal cover 4d comprises a distal flexible main flange 21 and a proximal flexible 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 concave annular cavity 22 matching the outer ring 19.

[0048] The main sealing cover 4d includes a first pipe opening 27a and a first axis 271a, a second pipe opening 27b and a second axis 271b, a third pipe opening 27c and a third axis 271c, a fourth pipe opening 27d and a fourth axis 271d, and a first segmentation pleat 310, a second segmentation pleat 320, a third segmentation pleat 330 and a fourth segmentation pleat 340, which are disposed in and penetrate the main dome 25.

[0049] In an optional design, the first segmented fold 310 starts from the vicinity of the intersection of the main shell and the main dome on the left side of the first pipe opening 27a, and extends circumferentially around the first pipe opening 27a to the vicinity of the intersection of the main shell and the main dome on the right side thereof; thereby defining the first dome area 25a. The first segmented fold 310 includes a plurality of first folds, each of which includes a fold peak 311, a fold valley 313, and a fold wall 312 extending therebetween. Figure 20-21 As shown in the cross-section, the first dome fold area 25a is separated from the main dome 25; as viewed from an overall perspective, the first dome area 25a is connected to the fold side surface to form a complete seamless membrane structure.

[0050] Similarly, the second segmented fold 320 starts from the vicinity of the intersection of the main shell and the main dome on the left side of the second nozzle 27b, and extends circumferentially around the second nozzle 27b to the vicinity of the intersection of the main shell and the main dome on the right side thereof, thereby defining the second dome area 25b. The second segmented fold 320 includes a plurality of second folds, each of which includes a fold peak 321, a fold valley 323, and a fold wall 322 extending therebetween.

[0051] Similarly, the third segmented fold 330 starts from the vicinity of the intersection of the main shell and the main dome on the left side of the third pipe opening 27c, and extends circumferentially around the third pipe opening 27c to the vicinity of the intersection of the main shell and the main dome on the right side thereof, thereby defining the third dome area 25c. The third segmented fold 330 includes a plurality of third folds, each of which includes a fold peak 331, a fold valley 333, and a fold wall 332 extending therebetween.

[0052] Similarly, the fourth segmented fold 340 starts from the vicinity of the intersection of the main shell and the main dome on the left side of the fourth pipe opening 27d, and extends circumferentially around the fourth pipe opening 27d to the vicinity of the intersection of the main shell and the main dome on the right side thereof, thereby defining the fourth dome area 25d. The fourth segmented fold 340 includes a plurality of fourth folds, each of which includes a fold peak 341, a fold valley 343, and a fold wall 342 extending therebetween.

[0053] The main sealing cover 4d replaces the main sealing cover 4 to form a new sealing system 3d (not shown in the figure), and the main sealing cover 4d has similar beneficial effects as the main sealing cover 4. That is, the main sealing cover 4d includes two states: an initial state and a gas-deformed state. In the initial state, the main axis 8 of the main sealing cover is substantially parallel to the first axis 271a, the second axis 271b, the third axis 271c and the fourth axis 271d.

[0054] Gas deformation state: When the single-incision access device is in clinical working conditions (or the main flange 21 is closed to form an airtight condition), gas is injected into the sealing system 3d and the gas pressure of 2000±300 Pa is maintained, and the first, second, third, and fourth segmented folds are stretched and deformed. The first, second, third, and fourth segmented folds are asymmetrically arranged relative to the tube openings of their sleeves, and the folds toward the central area of ​​the main sealing cover have a greater degree of freedom, while the folds adjacent to the main shell have a smaller degree of freedom; therefore, under the action of gas pressure, the first dome area and the first tube opening are turned over or deflected in a direction away from the center of the main sealing cover; the second dome fold area and the second tube opening are turned over or deflected in a direction away from the center of the main sealing cover; the third dome area and the third tube opening are turned over or deflected in a direction away from the center of the main sealing cover; the fourth dome area and the fourth tube opening are turned over or deflected in a direction away from the center of the main sealing cover.

[0055] refer to Figure 18-Figure 21In an optional solution, the area where the first pipe opening 27a is the shortest distance from the main shell 23 is provided with a transverse rib 251a extending transversely and connecting multiple pleated walls. The transverse rib 251a can prevent the pleats in the adjacent area from stretching and deforming, thereby forming a more obvious way to cause the first pipe opening to flip or deflect in a direction away from the center of the main sealing cover. Similarly, the area where the second pipe opening 27b is the shortest distance from the main shell 23 is provided with a transverse rib 251b extending transversely and connecting multiple pleated walls; the area where the third pipe opening 27c is the shortest distance from the main shell 23 is provided with a transverse rib 251c extending transversely and connecting multiple pleated walls; the area where the fourth pipe opening 27d is the shortest distance from the main shell 23 is provided with a transverse rib 251d extending transversely and connecting multiple pleated walls.

[0056] The main sealing cover 4d has a similar design concept to the main sealing cover 4. However, the cross section of the folds of the main sealing cover 4d is U-shaped, and the stretching and deformation of the divided folds are easier. Under the same design size, the deformation range is larger.

[0057] Continue to refer Figure 18-Figure 21 In an optional solution, the main sealing cover 4d further includes a central fold area 350. The central fold area 350 includes a plurality of annular folds, each of which includes a fold peak 351, a fold valley 353 and a fold wall 352 extending therebetween. Under the same design size, the central fold area 350 can make the deformation range larger.

[0058] Figure 22-Figure 24Another sealing tube assembly 500 is depicted. The sealing tube assembly 500 includes a first rigid ring 510, a flexible sealing tube 520, a flexible one-way valve 530 and a second rigid ring 540. The flexible sealing tube 520 includes a flexible distal flange 521, a flexible proximal membrane 529 and a sealing tube wall 525 connected thereto; the distal flange 521 includes tube through holes 522 that are roughly evenly distributed in the circumferential direction; the flexible membrane 49 includes an instrument sealing hole 528. The flexible one-way valve 530 includes a flexible proximal flange 531, a valve plate 539 and a valve side wall 533 connected thereto. The proximal flange 531 includes valve through holes 532 that are roughly evenly distributed in the circumferential direction. The first rigid ring 510 includes a first rigid ring body 511 and rigid columns 512 that are roughly evenly distributed along the circumferential direction; the second rigid ring 540 includes a second rigid ring body 541 and rigid ring fixing holes 542 that are roughly evenly distributed along the circumferential direction. The first pipe opening 27a of the main sealing cover 4 is provided with a first pipe opening flange 273a matching the sealing pipe assembly 500, and dome through holes 275a (not shown in the figure) penetrating the flange 273a and roughly evenly distributed along the circumference thereof. The first rigid ring body 511 and the second rigid ring body 541 sandwich the first pipe opening flange 273a, the proximal flange 541 and the distal flange 521 therebetween, so that they are stacked on each other and the rigid column passes through the corresponding through hole and is then inserted into the rigid ring fixing hole 72 to form a tight connection, so that the flexible material between the first rigid ring body 511 and the second rigid ring body 541 is in a compressed state to form an airtight fixation.

[0059] like Figure 23-Figure 24 The sealing tube assembly 500 replaces the sealing tube assembly 5 to form another sealing system 3e. The main difference between the sealing system 3e and the sealing system 3 is that the sealing tube assembly is different. The other components are the same, and the two have similar beneficial effects.

[0060] Those skilled in the art should be able to understand that the flexible sealing tube 520 can be integrated with the main sealing cover to form an integral whole; or the flexible one-way valve 530 can be integrated with the main sealing cover to form an integral whole. This can reduce molds, reduce component manufacturing time, and reduce assembly links.

[0061] Those skilled in the art should be able to understand that the technical features disclosed in the various examples of the present invention can be combined with each other, such as a combination of several existing folds and fold sections. Although the disclosed examples include the first, second, third, and fourth fold areas or segmented fold areas, it can also be composed of two or three or more card fold areas. The examples describe the use of first, second, third, fourth, etc. to distinguish different features, but it should not be understood as a limitation on the order of precedence. The words "left" and "right" in this article are mainly for the convenience of distinction during description, not for fixed perspectives, and should not be interpreted as restrictive.

[0062] Many different embodiments and examples of the present 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 present 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 present invention when viewed from an overall perspective, they still fall within the scope of protection of the present invention. Many different embodiments and examples of the present 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 present 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 present 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 main sealing cover of a single-incision access device, comprising a distal main flange and a proximal main dome and a main shell extending therebetween; the main flange, the main dome and the main shell together define a main cavity, characterized in that: 1) The main sealing cover further comprises a plurality of fold areas, each fold area comprises a plurality of folds, and each fold comprises a fold peak, a fold valley and a fold wall extending therebetween; 2) The fold zone starts from the vicinity of the intersection of the main shell and the dome and extends laterally toward the center of the dome; and divides the main dome into three or more dome zones; 3) Any of the dome regions includes a tube opening penetrating through the main dome and extending toward the proximal end.

2. The main sealing cover according to claim 1, characterized in that: The fold area includes a first fold area and a second fold area; the first and second fold areas divide the main dome into a first dome area, a second dome area and a third dome area.

3. The main sealing cover according to claim 2, characterized in that: The main sealing cover also includes a central annular shell, which includes a central revolving wall with uniform wall thickness and intersecting with the first fold area and the second fold area at the same time; the central revolving wall extends and intersects with the fold peaks, fold walls, and fold valleys to form a partially closed wave lip structure and a seamless membrane structure.

4. The main sealing cover according to claim 1, characterized in that: 1) The main sealing cover comprises a first nozzle, a second nozzle and a third nozzle which penetrate the main dome and extend toward the proximal end; the fold area comprises a first segmentation fold, a second segmentation fold and a third segmentation fold; 2) The first segmented fold starts from the vicinity of the intersection of the main shell and the main dome on the left side of the first pipe opening, first extends laterally inward toward the center of the main sealing cover, and then turns back and extends laterally outward to the vicinity of the intersection of the main shell and the main dome on the right side of the first pipe opening, defining the first dome area; 3) The second segmented fold starts from the vicinity of the intersection of the main shell and the main dome on the left side of the second pipe opening, first extends laterally inward toward the center of the main sealing cover, and then turns back and extends laterally outward to the vicinity of the intersection of the main shell and the main dome on the right side of the second pipe opening, defining a second dome area; 4) The third segmented fold starts from the vicinity of the intersection of the main shell and the main dome on the left side of the third pipe outlet, first extends laterally inward toward the center of the main sealing cover, and then turns back and extends laterally outward to the vicinity of the intersection of the main shell and the main dome on the right side of the third pipe outlet, thereby defining the third dome area.

5. The main sealing cover according to claim 1, characterized in that: 1) The main seal includes a main axis, the pipe orifice includes a pipe axis, and the main seal cover includes two states: an initial state and a gas-deformed state; 2) In the initial state, the main axis is parallel to the tube axis; 3) In the gas deformation state, when all openings on the main sealing cover are blocked to form airtightness, gas is injected into the main cavity and the gas pressure of 2000±300 Pa is maintained, the fold area produces stretching deformation, so that the dome area and the pipe mouth are turned or deflected in the direction away from the center of the main sealing cover, and the first axis forms an angle A with the main axis.

6. The main sealing cover according to claim 5, characterized in that: 15°≤A＜90°。 7. The main sealing cover according to claim 1, characterized in that: 1) The main sealing cover comprises a first nozzle, a second nozzle and a third nozzle which penetrate the main dome and extend toward the proximal end; the fold area comprises a first segmentation fold, a second segmentation fold and a third segmentation fold; 2) The first segmented fold starts from the vicinity of the intersection of the main shell and the main dome on the left side of the first nozzle, and extends circumferentially around the first nozzle to the vicinity of the intersection of the main shell and the main dome on the right side thereof, thereby defining a first dome area; 3) The second segmented fold starts from the vicinity of the intersection of the main shell and the main dome on the left side of the second nozzle, and extends circumferentially around the second nozzle to the vicinity of the intersection of the main shell and the main dome on the right side thereof, thereby defining a second dome area; 4) The third segmented fold starts from the adjacent area where the main shell and the main dome meet on the left side of the first nozzle, and extends circumferentially around the third nozzle to the adjacent area where the main shell and the main dome meet on the right side, thereby defining a third dome area.

8. The main sealing cover according to claim 7, characterized in that: The area where the first pipe opening is at the shortest distance from the main shell is provided with transverse ribs extending transversely and connecting a plurality of fold walls, and the transverse ribs can prevent the folds in the adjacent area from stretching and deforming.

9. A sealing system, comprising a main sealing cover as claimed in any one of claims 1 to 8, and also comprising a sealing tube assembly, wherein the sealing tube assembly comprises a sealing membrane, a one-way valve, a first rigid ring and a second rigid ring; the sealing membrane and the one-way valve are clamped between the first rigid ring and the second rigid ring in a compressed state to form an airtight seal; the sealing tube assembly is connected to the pipe opening of the main sealing cover.

10. An access device, comprising the sealing system as described in claim 9, and further comprising 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 concave ring cavity matching the shape and size of the outer ring, and the inner concave ring cavity is detachably connected to the outer ring and forms an airtight seal.

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