Incision protection device, single-incision approach device and manufacturing and using methods of incision protection device and single-incision approach device

Abstract

The invention provides an incision protection device which comprises a first inner ring, a second outer ring, a third outer ring, a first outer membrane and a second inner membrane, the far end of the first outer membrane and the first inner ring extend and intersect to be connected into a whole, and the near end of the first outer membrane and the second outer ring extend and intersect to be connected into a whole. The near end of the second inner membrane and the third outer ring extend and intersect to be connected into a whole, and the far end of the second inner membrane and the first inner ring extend and intersect to form a complete weld joint or extend and intersect with the first outer membrane to form a membrane fusion belt. The second outer ring is of a semi-rigid structure made of a plastic material, the second outer ring is held by a hand to apply overturning torque to the interior of the second outer ring, the outer ring wall of the second outer ring can be twisted and overturned, and the first outer film in the area close to the second outer ring is wound around the outer surface of the second outer ring.

Description

Technical Field

[0001] The present invention relates to minimally invasive surgical instruments, and particularly to a laparoscopic minimally invasive access device. Background Art

[0002] Laparoscopic single-port surgery, that is, through a single incision in the patient's body wall, a laparoscope and multiple instruments are inserted and removed to complete a surgical operation. Usually, a single-incision access device is inserted into the patient's incision as a channel for the instruments to enter and exit the human body. Initially, laparoscopic single-port surgery used three conventional trocars inserted into a single patient incision to form a single-incision access device (referred to as the Mickey Mouse scheme), and this scheme had serious air leakage during the operation. Subsequently, it was improved to place an incision protection device at the incision, connect a soft rubber platform outside the incision protection device, and multiple conventional trocars pierce the soft rubber platform to form a single-incision access device (referred to as the R-Port scheme). Subsequently, the soft rubber platform was improved to connect a simplified conventional trocar to a soft rubber chamber body to form a single-incision access device (referred to as the triport scheme). The Triport scheme is one of the most widely used single-incision access devices in clinical applications at present. However, so far, single-incision access devices represented by Triport have defects in aspects such as the ultimate operating freedom in the surgical hemispherical space, interference between instruments during the operation, inconvenience in taking out objects during the operation, effectiveness of smoke evacuation during the operation, and adjustment of the patient's incision size, which seriously hinders the development of laparoscopic single-port surgery. Summary of the Invention

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

[0004] In one aspect of the present invention, an incision protection device is proposed. The incision protection device includes a first inner ring, a second outer ring, and a first outer membrane. The first outer membrane is made of a plastic film into a long tubular flexible pipe structure. The distal end of the first outer membrane intersects and is integrated with the extension of the first inner ring, and the proximal end of the first outer membrane intersects and is integrated with the extension of the second outer ring. The incision protection device further includes a second inner membrane and a third outer ring. The second inner membrane is made of a plastic film into a long tubular flexible seamless pipe structure. The proximal end of the second inner membrane intersects and is integrated with the extension of the third outer ring. The distal end of the second inner membrane intersects with the extension of the first inner ring to form a complete weld seam or intersects with the extension of the first outer membrane to form a membrane fusion zone. The first inner ring is made of a thermosetting elastomer or thermoplastic elastomer material into a flexible or semi-rigid structure. The second outer ring is made of a plastic material into a semi-rigid structure. When a person holds the second outer ring by hand and applies a flipping torque to its interior, the outer wall of the second outer ring can be twisted and flipped, causing the first outer membrane in the adjacent area of the second outer ring to wrap around the outer surface of the second outer ring.

[0005] In one solution, a common membrane is formed between the membrane fusion zone and the first inner ring. The length of the first outer membrane is L1, the length of the second inner membrane is L2, and the length of the common membrane is L3, where L1 > L2 ≥ 2×L3.

[0006] In another solution, the first outer membrane and the second inner membrane are made of a plastic film to form a truncated conical pipe structure. The distal ends of the first outer membrane and the second inner membrane extend and intersect to form a whole, wrapping part or all of the first inner ring.

[0007] In another solution, it further includes a third inner membrane and a fourth outer ring. The third inner membrane is made of a plastic film to form a long cylindrical flexible seamless pipe structure. The distal end of the third inner membrane intersects with the side wall extension of the second inner membrane to form a membrane fusion zone. The membrane inside the inner circle of the fusion zone is removed to connect the pipe defined by the third inner membrane with the pipe defined by the second inner membrane. The proximal end of the third inner membrane intersects with the extension of the fourth outer ring to form a whole.

[0008] In another solution, it further includes a sealing component arranged at the fourth outer ring. The sealing component includes a one-way valve, a sealing valve, and a sealing upper cover. The one-way valve and the sealing valve are clamped between the sealing upper cover 83c and the fourth outer ring and are in a compressed state, forming a gas-tight connection among the fourth outer ring, the one-way valve, the sealing valve, and the sealing upper cover.

[0009] In another solution, the third outer ring includes a lower side ring, a one-way valve, and an upper side ring. The one-way valve includes a plurality of deflectable valve pieces. When inserting the instrument, the instrument pushes open the valve pieces to allow gas to pass through the valve pieces. When removing the instrument, the valve pieces automatically return to their original positions to close and form a gas seal. The lower side ring is integrally connected with the proximal end of the second inner membrane. The one-way valve is clamped between the lower side ring and the upper side ring and is in a compressed state to form a gas-tight connection.

[0010] On the other hand of the present invention, a notch access device is proposed. It includes any of the foregoing notch protection devices and further includes a sealing system. The sealing system includes a main sealing cover and a plurality of sealing tube components connected thereto. The main sealing cover includes a distal main flange, a proximal main dome, and a flexible main housing extending therebetween. The main flange, the main dome, and the main housing together define a main cavity. The main flange includes an inner ring cavity matching the shape and size of the outer ring outside the body. The inner ring cavity forms a detachable elastic interference connection with the outer ring outside the body and forms a gas seal.

[0011] On the other hand of the present invention, a manufacturing method of the foregoing notch protection device is proposed, including the following steps: 1) S1 Weld the membrane: First, cut the plastic film into appropriate sizes, then fold it in half so that the two long sides overlap and weld to form a weld seam, respectively making a long cylindrical first outer membrane and a first inner membrane. Then, nest the first outer membrane and the first inner membrane together and weld their overlapping distal ends to form a weld seam (i.e., the membrane fusion zone). 2) S2 Welding Rings: Weld the distal end of the first inner ring to the film, weld the second outer ring to the proximal end of the first outer film, and weld the third outer ring to the proximal end of the second inner film.

[0012] In another aspect of the present invention, another manufacturing method of the incision protection device is proposed, which includes the following steps: S1 Welding Film: First, cut the plastic film into a suitable size, then fold it in half so that the two long sides overlap and are welded to form a fusion seam, forming a flexible pipe structure in the shape of a truncated cone. S2 Welding Rings: Turn the smaller-diameter end of the truncated cone pipe inward to form an outer truncated cone film (the first outer film) and an inner truncated cone film (the second inner film). Weld the first inner ring to the transition area between the inner truncated cone film and the outer truncated cone film, then weld the second outer ring to the proximal end of the outer truncated cone film, and weld the third outer ring to the proximal end of the inner truncated cone film.

[0013] In another aspect of the present invention, another manufacturing method of the incision protection device is proposed, which includes the following steps: S1 Welding Film: Stack two plastic films and weld them to form a fusion seam, then cut off the excess film to form a combination of the second inner film and the third inner film; overlap and weld the long sides of a single film to form a fusion seam to form a long tubular first outer film; then nest the first outer film and the first inner film together and weld their overlapping distal ends to form a fusion seam (i.e., the film fusion zone).

[0014] S2 Welding Rings: Weld the first inner ring to the distal end of the film, weld the second outer ring to the proximal end of the first outer film, weld the third outer ring to the proximal end of the second inner film, and weld the fourth outer ring to the proximal end of the third inner film.

[0015] In another aspect of the present invention, another manufacturing method of the said incision protection device is proposed, which includes the following steps: S1 Welding Film: Stack two plastic films and weld them according to the drawing to form a fusion seam, then cut off the excess film to form a combination of the first outer film, the second inner film and the third inner film; S2 Welding Rings: Turn the distal end of the film welded in the previous step outward. The rolled-up outer ring film forms the first outer film and its inner ring film forms the second inner film. Weld the first inner ring to the transition area between the first outer film and the second inner film, then weld the second outer ring to the proximal end of the first outer film, weld the third outer ring to the proximal end of the second inner film, and weld the fourth outer ring to the other proximal opening of the film. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more fully understand the essence of the present invention, the following will be described in detail with reference to the drawings, wherein: Figure 1 is a partial three-dimensional sectional view of the incision protection device 1; Figure 2is the front view of the incision protection device 1 from the distal end to the proximal end; Figure 3 is Figure 2 the sectional view taken along line 3-3; Figure 4 is the simulated schematic diagram after the second outer ring twists, flips and wraps the first outer membrane; Figure 5 is Figure 4 the longitudinal sectional view of the incision protection device shown; Figure 6 is the 3D view of the incision access device 2; Figure 7 is the partial 3D sectional view of the main seal cover 100; Figure 8 is the schematic diagram of the welding process of the first outer membrane 20 or the second inner membrane 40; Figure 9 is the schematic diagram of the welding process of the first outer membrane and the second inner membrane to form the membrane fusion zone; Figure 10 is the partial 3D sectional view of the incision protection device 1a; Figure 11 is the schematic diagram of the welding process of the first outer membrane 20a and the second inner membrane 40a; Figure 12 is the 3D view of the incision protection device 1b; Figure 13 is the front view of the flexible incision protection device 1b from the proximal end to the distal end; Figure 14 is Figure 13 the sectional view taken along line 14-14; Figure 15 is the 3D view of the incision access device 2b; Figure 16 is the front view of the incision access device 2b from the proximal end to the distal end; Figure 17 is Figure 16 the sectional view taken along line 17-17; Figure 18 is the 3D view of the incision protection device 1c; Figure 19 is the 3D view of the incision access device 2c; Figure 20 is the schematic diagram of the welding process of the first outer membrane 20b, the second inner membrane 40b and the third inner membrane 60b; In all views, the same reference numerals denote equivalent parts or components. Detailed implementation

[0017] 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 content disclosed herein is not to be construed as restrictive, but only as the basis for the claims and as the basis for teaching those skilled in the art how to use the present invention. The disclosed embodiments of the present invention will now be described in detail with reference to the accompanying drawings. For the convenience of description, in the following, the side closer to the operator is defined as the proximal end, and the side farther from the operator is defined as the distal end.

[0018] Figures 1 - 3 The structure and composition of an incision protection device 1 are depicted.

[0019] The incision protection device 1 includes a first inner ring 10, a second outer ring 30, and a first outer membrane 20. The first outer membrane 20 is made of a plastic film into a long cylindrical flexible pipe structure. Its first outer membrane distal end 21 intersects and is integrally connected with the extension of the first inner ring 10, and its first outer membrane proximal end 29 intersects and is integrally connected with the extension of the second outer ring 30.

[0020] The incision protection device 1 further includes a second inner membrane 40 and a third outer ring 50. The second inner membrane 40 is made of a plastic film into a long cylindrical flexible seamless pipe structure. Its second inner membrane distal end 41 intersects with the extension of the first outer membrane 20 to form a membrane fusion zone 22, and its second inner membrane proximal end 49 intersects and is integrally connected with the extension of the third outer ring 50. A common membrane 25 is formed between the membrane fusion zone 22 and the inner ring 10.

[0021] The first inner ring 10 is made of a thermosetting elastomer material (such as silicone rubber, isoprene rubber, latex, etc.) or a thermoplastic elastomer TPE material (such as polyurethane TPU, vulcanized rubber TPV, etc.) into a flexible or semi-rigid structure. The incision protection device 1 is placed at the incision of the patient's body wall. The first inner ring 10 and the first outer membrane 20 in its adjacent area can be compressed and deformed to pass through the incision of the patient's body wall. Once the first inner ring 10 completely passes through the body wall incision and enters the patient's body cavity (or a local space equivalent to the body cavity artificially established) and is released, the first inner ring 10 can automatically recover to form a substantially circular ring, and the first outer membrane in its adjacent area is then pulled outwards and closely adheres to the inner surface of the patient's body wall incision.

[0022] The second outer ring 30 is made of a plastic material into a semi-rigid structure. When the user manually holds the second outer ring 30 and applies a flipping torque to its interior, the outer ring wall 35 of the outer ring 30 can be twisted and flipped, causing the first outer membrane 20 in the adjacent area of the second outer ring 30 to wrap around and wrap around the outer surface of the second outer ring 30. The outer ring 30 can be flipped multiple times to make the first outer membrane 20 wrap around the outer ring 30 multiple times and in multiple layers. Figure 1 The arrow depicts the flipping direction, Figure 4 and Figure 5Depicts a simulation schematic diagram after the second outer ring 30 twists, flips, and wraps the first outer membrane 20.

[0023] In the US Invention Application US20070088202A1 (hereinafter referred to as 202A1), various structural designs of the second outer ring that are beneficial to such flipping are listed. Research shows that the "8" and "0" - shaped cross - section second outer ring structures disclosed therein have good flipping effects. The schematic diagrams and methods of the aforementioned "flipping" and "wrapping" are disclosed in detail in the aforementioned literature and will not be elaborated here.

[0024] Those skilled in the art should be able to understand that when the first inner ring 10 is in the patient's body and elastically resumes its shape, the first outer membrane 20 passes through the patient's incision. The muscles and tissues of the patient's incision squeeze the first outer membrane inward and force the inner diameter of the flexible pipe space defined by the first outer membrane to become smaller, thereby forming tension in the first outer membrane. Flipping the second outer ring 30 and wrapping the first outer membrane 20 can shorten the length of the unwrapped first outer membrane between the first inner ring and the second outer ring, thereby increasing the tension on the first outer membrane. The shorter the length of the unwrapped membrane of the first outer membrane, the greater the tension of the first outer membrane. Furthermore, the tension of the first outer membrane is used to squeeze and expand the patient's incision to the desired size.

[0025] Figures 6 - 7 Depicts an incision access system 2 comprising an incision protection device 1 and a sealing system 3. The sealing system 3 comprises a main sealing cover 100 and a plurality of sealing tube assemblies connected thereto. The main sealing cover 100 comprises a distal main flange 101, a proximal main dome 103, and a flexible main housing 102 extending therebetween. The main flange, main dome, and main housing together define a main cavity 104. The main flange comprises an inner ring cavity 105 that matches the shape and size of the third outer ring 50. The inner ring cavity and the outer ring form a detachable elastic interference connection and form an airtight seal.

[0026] In this embodiment, the main sealing cover 100 comprises four sealing tube assemblies, namely, sealing tube assemblies 111, 112, 113, and 114. However, it may also comprise fewer or more sealing tube assemblies. Each sealing tube assembly further comprises a one - way valve 121 and an instrument sealing valve 122. The instrument sealing valve 122 is used to accommodate and wrap the instrument inserted therein and form an airtight seal. The one - way valve 121 is used to automatically close when the instrument is withdrawn or no instrument is inserted, thereby preventing gas leakage.

[0027] For simplicity of description, the detailed structures and connection relationships of the main seal cover and the seal tube assembly are not disclosed in this embodiment. Chinese Invention Applications CN110179505A, CN119385662A, CN119367012A, etc. disclose the detailed structures of various main seal covers and seal tube assemblies. Those skilled in the art can use the disclosed prior art and make adaptive modifications to replace the main seal cover 100 in this embodiment to form a new embodiment, which does not depart from the idea of the present invention.

[0028] The film thicknesses of the first outer membrane 20 and the second inner membrane 40 are generally 0.05 mm to 0.15 mm, and the third outer ring 50 can be made of a plastic material into a semi-rigid structure. Similarly, when the user holds the third outer ring with a bare hand and applies a flipping torque thereto, the outer ring wall of the third outer ring can be twisted and flipped, so that the second outer membrane in the adjacent area of the third outer ring wraps and covers around the outer surface of the third outer ring. The main seal cover 100 is made of an elastic material such as silicone rubber or isoprene rubber, and the inner ring cavity 105 can be elastically deformed and adapted to wrap the third outer ring after wrapping.

[0029] Since wrinkles and accumulations are likely to occur on the surface of the second inner membrane on the third outer ring during the process of twisting and wrapping the third outer ring with the second inner membrane, such wrinkles and accumulations are likely to damage the airtight seal between it and the inner ring cavity 105. In order to maintain its airtight seal, it is necessary to increase the interference amount between the inner ring cavity and the third outer ring, which makes it inconvenient to disassemble during the operation. In an improved solution, the third outer ring 50 is made of a metal material or a plastic material into a rigid structure, and the rigid third outer ring 50 cannot be twisted, deformed or flipped. The rigid third outer ring and the inner ring cavity 105 can achieve a precise and reliable airtight connection.

[0030] Those skilled in the art should be able to understand that the incision protection device 1 has at least two improvements compared with the incision protection device disclosed in the invention application 202A1: First, during the operation, the stretching size of the patient's incision can be adjusted secondarily or multiple times conveniently and quickly. The adjustment method is simple and fast. As described above, a flipping torque is applied inside the second outer ring, causing the second outer ring to twist and flip, and the first outer membrane to wrap around the outer surface of the second outer ring, thereby shortening the length of the unwrapped first outer membrane between the first inner ring and the second outer ring, and then expanding the size of the incision. By twisting and flipping in the reverse direction, the wrapped first outer membrane is released, increasing the length of the unwrapped first outer membrane, thereby reducing the tension in the first outer membrane and reducing the retraction of the patient's incision. There are many clinical application scenarios where the size of the patient's incision needs to be adjusted secondarily or multiple times during the operation. For example, in single-incision cholecystectomy, about 90% of the operation time is used to separate and expose the blood vessels and bile ducts in the gallbladder triangle. During this period, the diameter of the instruments entering the patient's body is relatively small. About 10% requires the use of a thick-diameter clip applicator. At this time, the patient's incision needs to be briefly expanded, and the incision is reduced again after the clamping is completed. This is beneficial to reducing the damage to the patient's wound. However, for the incision protection device disclosed in 202A1, the main seal cover installed on it must be removed first, that is, after destroying the pneumoperitoneum state of the patient, the size of the incision can be adjusted.

[0031] Second, for the incision protection device described in the present invention, the main seal cover is integrated with the third outer ring and the second inner membrane. When various angularly moving and swinging instruments are used during the operation, it has greater deformation ability and more degrees of freedom of movement. However, for the incision protection device disclosed in 202A1, its second outer ring and the first outer membrane are closely attached to the patient's incision and are connected to the main seal cover at the same time, restricting the swinging space of the instruments.

[0032] As Figure 3 shown, the length L1 of the first outer membrane, the length L2 of the second inner membrane, and the length L3 of the common membrane. Among them, L1 and L2 represent the distance from the proximal end of the measured membrane to the distal end of the membrane, and L3 represents the distance from the fusion zone 22 of the measured membrane to the distal end of the membrane. In a preferred solution, L1, L2, and L3 satisfy the following relationship: L1 > L2 ≥ 2×L3. This size design is beneficial for conveniently adjusting the size of the patient's incision while taking into account the free movement and swing of the second inner membrane.

[0033] Figures 8 - 9 Describes the manufacturing method of the incision protection device 1: S1 Welding the membranes: First, cut the plastic film into appropriate sizes, then fold it in half so that the two long sides overlap and are welded to form a weld seam, respectively making the long tubular first outer membrane and the first inner membrane; then nest the first outer membrane and the first inner membrane together and weld their overlapping distal ends to form a weld seam (i.e., the membrane fusion zone) ( Figures 8 - 9 The grid area of

[0034] represents the weld seam).

[0035] Figure 10 depicts the structure and composition of another incision protection device 1a.

[0036] The incision protection device 1a includes a first inner ring 10a, a second outer ring 30a, and a first outer membrane 20a. The first outer membrane 20a is made of a plastic film and forms a flexible conical pipe structure. Its distal end 21a of the first outer membrane intersects and is integrally connected with the extension of the first inner ring 10a, and its proximal end 29a of the first outer membrane intersects and is integrally connected with the extension of the second outer ring 30a.

[0037] The incision protection device 1a further includes a second inner membrane 40a and a third outer ring 50a. The second inner membrane 40a is made of a plastic film and forms a flexible seamless pipe structure in a conical shape. Its distal end 41a of the second inner membrane intersects and is integrally connected with the extension of the first inner ring 10a, and its proximal end 49a of the second inner membrane intersects and is integrally connected with the extension of the third outer ring 50a.

[0038] The first inner ring 10a is made of materials such as silicone rubber and thermoplastic elastomer TPE material (polyurethane TPU) to form a flexible or semi-rigid structure. The second outer ring 30a is made of a plastic material to form a semi-rigid structure. The shown incision protection device 1a is similar to the incision protection device 1a, and the main difference is that the distal ends of the shown first outer membrane 20a and the second inner membrane 40a do not extend and intersect to form a common membrane. The clinical use method of the shown device 1a is the same as that of device 1 and will not be elaborated here.

[0039] To reduce the production cost of device 1, a simplified manufacturing method of an incision protection device 1a is proposed as follows: S1 Welding the membrane: First, cut the plastic film into a suitable size, then fold it in half so that the two long sides overlap and are welded to form a weld seam, forming a flexible conical pipe structure ( Figure 11 The grid area represents the weld seam).

[0040] S2 Welding the rings: Turn the smaller-diameter end of the conical pipe inside out to form an outer conical membrane (the first outer membrane 20a) and an inner conical membrane (the second inner membrane 40a). Weld the first inner ring at the turning area of the inner conical membrane and the outer conical membrane, then weld the second outer ring at the proximal end of the outer conical membrane, and weld the third outer ring at the proximal end of the inner conical membrane.

[0041] Those skilled in the art should easily think that since the shown first outer membrane and the first inner membrane are compliant and easily deformable, the plastic film can also be cut into a suitable size, then folded in half so that the two long sides overlap and are welded to form a weld seam, forming a cylindrical flexible pipe structure. Then, one end of the cylindrical pipe is turned inside out, thereby forming an outer cylindrical membrane (the first outer membrane) and an inner cylindrical membrane (the second inner membrane). The first inner ring is welded to the turning area of the inner cylindrical membrane and the outer cylindrical membrane, then the second outer ring is welded to the proximal end of the outer cylindrical membrane, and the third outer ring is welded to the proximal end of the inner cylindrical membrane. It is also possible to cut and weld a part to form a truncated conical membrane and cut and weld a part to form a cylindrical membrane. That is, a combination of a cylindrical membrane and a truncated conical membrane. The distal ends of the first outer membrane 20a and the second inner membrane 40a in the device 1a do not extend and intersect to form a common membrane. However, the welding position can also be changed to construct a common membrane similar to that of the device 1.

[0042] Figures 12 - 14 Depicts the structure and composition of another incision protection device 1b.

[0043] The incision protection device 1b includes a first inner ring 10b, a second outer ring 30b, and a first outer membrane 20b. The first outer membrane 20b is made of a plastic film into a long cylindrical flexible pipe structure. Its distal end 21b of the first outer membrane extends and intersects with the first inner ring 10b to be integrated, and its proximal end 29b of the first outer membrane extends and intersects with the second outer ring 30b to be integrated.

[0044] The incision protection device 1b further includes a second inner membrane 40b and a third outer ring 50b. The second inner membrane 40b is made of a plastic film into a long cylindrical flexible seamless pipe structure. Its distal end 41b of the second inner membrane extends and intersects with the first outer membrane 20b to form a membrane fusion zone 22b. Its proximal end 49b of the second inner membrane extends and intersects with the third outer ring 50b to be integrated. A common membrane 25b is formed between the membrane fusion zone 22b and the inner ring 10b.

[0045] The incision protection device 1b further includes a third inner membrane 60b and a fourth outer ring 70b. The third inner membrane 60b is made of a plastic film into a long cylindrical flexible seamless pipe structure. Its distal end 61b of the third inner membrane extends and intersects with the side wall of the second inner membrane 40b to form a membrane fusion zone 62b. The membrane inside the inner circle of the fusion zone is removed so that the pipe defined by the third inner membrane communicates with the pipe defined by the second inner membrane. Its proximal end 69b of the third inner membrane extends and intersects with the fourth outer ring 70b to be integrated.

[0046] For the convenience of observing and understanding the structure and composition of the incision protection device 1b, Figures 12 - 14 the length of the first outer membrane depicted is shorter than the length of the second inner membrane. However, it is also appropriate that the length of the first outer membrane is greater than or equal to the length of the second inner membrane. Since the cylindrical flexible pipes formed by the first outer membrane, the second inner membrane, and the third inner membrane are deformable, their actual shapes are the same as Figures 12 - 14The depicted simulation graphics may vary significantly.

[0047] The first inner ring 10b is made of materials such as silicone rubber and thermoplastic elastomer TPE (polyurethane TPU) to form a flexible or semi-rigid structure. The second outer ring 30b is made of plastic material to form a semi-rigid structure. The method of using the incision protection device 1b and the incision protection device 1 for fixing at the patient's incision is the same and will not be elaborated here.

[0048] Those skilled in the art should easily understand that the third outer ring 50b and the third outer ring 70b can be respectively connected to different main seal covers, thereby constructing two independent sealing systems, which is more convenient for intraoperative operation.

[0049] Such as Figures 15 - 17 In another implementation, the incision protection device 1b further includes a sealing assembly 80b provided at the fourth outer ring. The sealing assembly 80b includes a one-way valve 81b, a sealing valve 82b, and a sealing upper cover 83c. The one-way valve 81b and the sealing valve 82b are made of materials such as silica gel or isoprene rubber. The two are sandwiched between the sealing upper cover 83c and the fourth outer ring 70b and are in a compressed state, so as to form an airtight connection between the fourth outer ring, the one-way valve, the sealing valve, and the sealing upper cover. The one-way valve 81b includes a plurality of rotatable and openable valve pieces, which can automatically close to form a seal when no instrument is inserted. The sealing valve 82b can form a seal for the inserted instrument. In another solution, the sealing upper cover 83c includes a hollow air nozzle 85b. The one-way valve 81b and the sealing valve 82b include through holes communicating with the air nozzle, and gas can be injected into the pipeline defined by the third inner membrane 60 through the air nozzle.

[0050] Figures 15 - 17 Depicts an incision access system 2b including an incision protection device 1b and a sealing system 3. The sealing system 3 includes a main seal cover 100 and a plurality of seal tube assemblies communicating therewith. The main seal cover 100 includes a distal main flange 101, a proximal main dome 103, and a flexible main housing 102 extending therebetween. The main flange, the main dome, and the main housing together define a main cavity 104. The shape and size of the third outer ring 50b match the inner ring cavity 105, and the inner ring cavity and the outer ring form a detachable elastic interference connection and form an airtight seal.

[0051] Those skilled in the art should be able to understand that the main beneficial effects of the incision access system 2b compared to the existing single-incision access system are as follows: An endoscope can be inserted via the sealing assembly 80b, and gas can be injected via the gas nozzle 85b. In this case, if a relatively large object such as a patient tissue or a hemostatic gauze needs to be removed during the operation, the object can be first removed through the duct defined by the second inner membrane into the main sealing cover, then the second inner membrane can be closed with a clip or a tying rope, and then the main sealing cover can be removed to conveniently take away the foreign object. This process can maintain real-time video monitoring of the patient's body while not losing the inflated state. When taking objects with the existing single-incision access system, the inflated state and the monitoring state are usually necessarily lost.

[0052] As Figure 18 Another incision protection device 1c is depicted. The incision protection device 1c is substantially the same as the incision protection device 1b, with the main difference lying in the setting of the third outer ring. Briefly speaking, the incision protection device 1c includes a first inner ring 10b, a second outer ring 30b, a first outer membrane 20b, a second inner membrane 40b, a third inner membrane 60b, a fourth outer ring 70b, and a sealing assembly 80b. The device 1c also includes a third outer ring 50c, and the third outer ring 50c includes a lower side ring 51c, a one-way valve 52c, and an upper side ring 53. The one-way valve 52c includes a plurality of deflectable valve sheets. When an instrument is inserted, the instrument pushes open the valve sheets so that gas can pass through the valve sheets. When the instrument is removed, the valve sheets automatically return to their original state and close to form an airtight seal. The lower side ring 51c is integrally connected to the proximal end of the second inner membrane 40b, and the one-way valve 52c is clamped between the lower side ring 51c and the upper side ring 53c and is in a compressed state to form an airtight connection. Those skilled in the art should be able to understand that replacing the third outer ring 5b in the device 1b with the third outer ring 5c constitutes the device 1c.

[0053] Figure 19 An incision access system 2c is depicted, which includes the incision protection device 1c and a sealing system 3. The shape and size of the third outer ring 50c match those of the inner ring cavity 105, and the inner ring cavity and the third outer ring form a detachable elastic interference connection to form an airtight seal. Similarly, when a relatively large object needs to be removed from the patient's body during clinical application, the object to be removed can be clamped and removed via the one-way valve 52c, and then the sealing system 3 can be disassembled. This process can maintain real-time video monitoring of the patient's body while not losing the inflated state.

[0054] Combined with Figure 8 and Figure 20 Understand the manufacturing method of the incision protection device 1b: S1 Welding the film: After stacking two plastic films, press Figure 20Welding forms a fusion seam and cuts off the redundant film to form the combination of the second inner film and the third inner film; the long sides of the single-piece films are overlapped and welded to form a fusion seam to form a long tubular first outer film; then the first outer film and the first inner film are nested together and their overlapping distal ends are welded to form a fusion seam (i.e., the film fusion zone).

[0055] S2 Welding rings: Weld the distal end of the first inner ring, weld the second outer ring to the proximal end of the first outer film, weld the third outer ring to the proximal end of the second inner film, and weld the fourth outer ring to the proximal end of the third inner film.

[0056] Combination Figure 17 And Figure 20 Understand another simplified manufacturing method of the incision protection device 1b: S1 Welding films: Stack two plastic films and press Figure 20 Welding forms a fusion seam and cuts off the redundant film to form the combination of the first outer film, the second inner film and the third inner film ( Figure 20 The grid area represents the fusion seam).

[0057] S2 Welding rings: Turn the distal end of the welded film in the previous step outwards. The rolled-up outer ring film forms the first outer film and its inner ring film forms the second inner film. Weld the first inner ring at the turning area of the first outer film and the second inner film, then weld the second outer ring to the proximal end of the first outer film, weld the third outer ring to the proximal end of the second inner film, and weld the fourth outer ring to the other proximal opening of the film.

[0058] Those skilled in the art should easily think that the features of the foregoing different embodiments can be mutually replaced and recombined, or the features in each example can be borrowed to fuse and add more features, so as to form a new implementation scheme. A person of ordinary skill in the art can make adaptive improvements to the said method and instrument by appropriate modification without departing from the scope of the present invention. As long as these modified schemes are observed from an overall perspective and are still basically the same as the idea of the present invention, they still fall within the scope of protection of the present invention. Many different implementation schemes 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 said method and instrument by appropriate modification without departing from the scope of the present invention. Several modified schemes have been mentioned, and other modified schemes can also be thought of by those skilled in the art. Therefore, the scope of the present invention should be in accordance with the appended claims and should not be construed as being limited by the specific contents of the structures, materials or behaviors shown and recorded in the specification and drawings.

Claims

1. An incision protection device, characterized in that: 1) The incision protection device comprises a first inner ring, a second outer ring and a first outer membrane, wherein the first outer membrane is made of a plastic film and is a long cylindrical flexible pipe structure, wherein the distal end of the first outer membrane is extended to intersect and connect with the first inner ring, and the proximal end of the first outer membrane is extended to intersect and connect with the second outer ring; 2) The incision protection device further comprises a second inner membrane and a third outer ring, wherein the second inner membrane is made of a plastic film to form a long cylindrical flexible seamless pipe structure, wherein the proximal end of the second inner membrane extends and intersects with the third outer ring to form a whole, and the distal end of the second inner membrane extends and intersects with the first inner ring to form a complete weld or extends and intersects with the first outer membrane to form a membrane fusion zone; 3) The first inner ring is made of a thermosetting elastomer or a thermoplastic elastomer material to have a flexible or semi-rigid structure, and the second outer ring is made of a plastic material to have a semi-rigid structure. By holding the second outer ring with bare hands and applying a flipping torque to the inside thereof, the outer ring wall of the second outer ring can be twisted and flipped, so that the first outer membrane in the vicinity of the second outer ring is wrapped around the outer surface of the second outer ring.

2. The incision protection device according to claim 1, characterized in that: A common membrane is formed between the membrane fusion zone and the first inner ring, the first outer membrane has a length of L1, the second inner membrane has a length of L2, and the common membrane has a length of L3, wherein L1>L2≥2×L3.

3. The incision protection device according to claim 1, characterized in that: The first outer membrane and the second inner membrane are made of plastic film to form a truncated cone-shaped pipe structure. The distal ends of the first outer membrane and the second inner membrane extend to intersect and connect to form a whole, and wrap up part or all of the first inner ring.

4. The incision protection device according to claim 1, characterized in that: It also includes a third inner membrane and a fourth outer ring. The third inner membrane is made of a plastic film to form a long cylindrical, flexible, seamless pipe structure. The distal end of the third inner membrane extends and intersects with the side wall of the second inner membrane to form a membrane fusion zone. The membrane of the inner circle of the fusion zone is removed to make the pipe defined by the third inner membrane communicate with the pipe defined by the second inner membrane. The proximal end of the third inner membrane extends and intersects with the fourth outer ring to form a whole.

5. The incision protection device according to claim 4, characterized in that: It also includes a sealing component arranged at the fourth outer ring, which includes a one-way valve, a sealing valve and a sealing upper cover; the one-way valve and the sealing valve are clamped between the sealing upper cover 83c and the fourth outer ring and are in a compressed state, so that an airtight connection is formed between the fourth outer ring, the one-way valve, the sealing valve and the sealing upper cover.

6. The incision protection device according to claim 4, characterized in that: The third outer ring includes a lower ring, a one-way valve and an upper ring, and the one-way valve includes a plurality of deflectable valve sheets; when the instrument is inserted, the instrument pushes the valve sheet open to allow gas to pass through the valve sheet; when the instrument is removed, the valve sheet automatically restores and closes to form an airtight seal; the lower ring is connected to the proximal end of the second inner membrane, and the one-way valve is clamped between the lower ring and the upper ring and is in a compressed state to form an airtight connection.

7. An incision access device, characterized in that: A cutting protection device comprising any one of claims 1 to 6, further comprising a sealing system; the sealing system comprises a main sealing cover and a plurality of sealing tube assemblies connected thereto; the main sealing cover comprises a distal main flange and a proximal main dome and a flexible main shell extending therebetween; the main flange, the main dome and the main shell together define a main cavity; the main flange comprises an inner ring cavity matching the shape and size of the outer ring, the inner ring cavity and the outer ring forming a detachable elastic interference connection and forming an airtight seal.

8. The method for manufacturing the incision protection device according to claim 1, comprising the following steps: 1) S1 welding film: First, the plastic film is cut into a suitable size, then folded in half so that the two long sides overlap and welded to form a weld seam, and a first outer film and a first inner film are made into a long tube; then the first outer film and the first inner film are nested together and their overlapping distal ends are welded to form a weld seam (i.e., a membrane fusion zone); 2) S2 welding ring: weld the first inner ring to the distal end of the membrane, weld the second outer ring to the proximal end of the first outer membrane, and weld the third outer ring to the proximal end of the second inner membrane.

9. The method for manufacturing the incision protection device according to claim 3, comprising the following steps: S1 welding film: first cut the plastic film into a suitable size, then fold it in half so that the two long sides overlap and weld them to form a weld seam, forming a truncated cone-shaped flexible pipe structure; S2 welding ring: turn the smaller diameter end of the truncated cone pipe inward to form an outer truncated cone membrane (first outer membrane) and an inner truncated cone membrane (second inner membrane), weld the first inner ring to the turning area between the inner truncated cone membrane and the outer truncated cone membrane, weld the second outer ring to the proximal end of the outer truncated cone membrane, and weld the third outer ring to the proximal end of the inner truncated cone membrane.

10. The method for manufacturing the incision protection device according to claim 4, comprising the following steps: S1 welding film: two pieces of plastic film are stacked and welded to form a weld seam and the excess film is cut to form a combination of the first outer film, the second inner film and the third inner film; S2 welding ring: roll the distal end of the membrane welded in the previous step outward, the rolled outer ring membrane constitutes the first outer membrane and the inner ring membrane constitutes the second inner membrane, weld the first inner ring at the turning point between the first outer membrane and the second inner membrane, then weld the second outer ring to the proximal end of the first outer membrane, weld the third outer ring to the proximal end of the second inner membrane, and weld the fourth outer ring to the other proximal end opening of the membrane.

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