Flexible retractor and single-hole approach device applying same

Abstract

A flexible retractor is presented that includes an incision sleeve assembly and a nesting ring assembly. The incision sleeve assembly comprises an in-vivo ring, an in-vitro ring and a film pipeline arranged between the in-vivo ring and the in-vitro ring. The film pipeline comprises a long-barrel-shaped flexible pipe made of a plastic film, the far end of the pipeline and the in-vivo ring extend and intersect to be connected into a whole, and the near end of the pipeline and the in-vitro ring extend and intersect to be connected into a whole. The incision sleeve assembly further comprises an outer membrane attached to the outer surface of the thin film pipeline, the far end and the near end of the outer membrane are welded to the outer surface of the pipeline to form a welding seam, the outer membrane, the welding seam and the thin film pipeline jointly define a diaphragm cavity, the outer membrane is cut off in the axial direction of the thin film pipeline through the longitudinal seam, and the diaphragm cavity is communicated with the outside. The nesting ring assembly comprises an embedded ring, an outer wrapping ring and a connecting piece, the embedded ring is installed in the diaphragm cavity, the outer wrapping ring is installed outside the outer diaphragm, and the embedded ring and the outer wrapping ring are connected into a whole through the connecting piece.

Description

Technical Field

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

[0002] Laparoscopic single-port surgery is a surgical procedure that involves inserting a laparoscope and multiple instruments through a single incision in the patient's body wall. Usually, a single-incision access device is inserted into the patient's incision as a passage for the instruments to enter and exit the 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), which had serious air leakage during the operation. Subsequently, it was improved to insert an incision sleeve at the incision and connect a soft rubber platform outside the incision sleeve. Multiple conventional trocars punctured the soft rubber platform to form a single-incision access device (referred to as the R-Port scheme). After that, 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 practice. 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 hinder the development of laparoscopic single-port surgery. Summary of the Invention

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

[0004] In one aspect of the present invention, a flexible retractor is proposed, which includes an incision sleeve assembly and a nested ring assembly. The incision sleeve assembly includes an inner body ring, an outer body ring, and a thin film duct disposed therebetween; the thin film duct includes a long tubular flexible tube made of plastic film, the distal end of the duct intersects and is integrally connected with the extension of the inner body ring, and the proximal end of the duct intersects and is integrally connected with the extension of the outer body ring. The incision sleeve assembly further includes an outer film attached to the outer surface of the thin film duct, the distal end and the proximal end of the outer film are respectively welded to the outer surface of the duct to form weld seams, the outer film, the weld seams, and the thin film duct jointly define a diaphragm cavity, and a longitudinal seam cuts the outer film along the axial direction of the thin film duct to communicate the diaphragm cavity with the outside. The nested ring assembly includes an inner nested ring, an outer nested ring, and a connecting member, the inner nested ring is installed in the diaphragm cavity, the outer nested ring is installed outside the outer film, and the connecting member connects the inner nested ring and the outer nested ring into one body.

[0005] In one solution, the weld seams include a proximal weld seam and a distal weld seam, the distance between the distal weld seam and the inner body ring is L1, and the outer diameter of the inner body ring is D1, where L1≥0.5×D1.

[0006] In another embodiment, the inner ring includes an inner ring wall and an inner ring through hole penetrating the ring wall; the outer ring includes an outer ring wall and an outer ring through hole penetrating the ring wall; and the connector includes a knob and a connecting arm. The inner ring through hole, the outer ring through hole and the longitudinal slit are aligned, and the connecting arm of the connector passes through the outer ring through hole and the longitudinal slit and is inserted into the inner ring through hole to connect the inner ring and the outer ring into one. The inner ring through hole includes an internal thread, and the connecting arm includes an external thread matching therewith. The connecting arm matches the inner ring through hole to form a threaded connection. When the threaded connection is loosened, the nested ring assembly can be moved along the longitudinal slit, thereby shortening or lengthening the length of the film pipe between the outer ring and the inner ring; when the threaded connection is locked, the nested ring assembly is locked with the outer film without generating relative movement.

[0007] In another embodiment, the inner ring includes an inner ring wall, the connecting piece is integrally connected with the inner ring wall and extends outward transversely to form a connecting arm, the outer ring includes an outer ring wall and an outer ring through hole penetrating the ring wall, and the connecting arm is inserted into the outer ring through hole after passing through the longitudinal slit. The outer ring is made of a thermoplastic elastomer material or a thermosetting elastomer material to form a flexible or semi-rigid annular structure, the inner diameter of the outer ring is smaller than the outer diameter of the inner ring, and the outer ring produces elastic deformation, thereby generating a certain clamping force on the outer surface of the inner ring.

[0008] In another embodiment, the inner ring includes an inner ring wall, the connecting piece is connected to the inner ring wall as a whole and extends outward laterally to form a connecting arm; the outer ring includes an outer ring wall and an outer ring through hole penetrating the ring wall, the outer ring wall also includes a cutting groove to completely cut the outer ring wall, forming a first ring and a second ring end; the first ring end includes a thin wall and a wrench connected thereto and extending outward, the wrench includes inner teeth, and the second ring end includes outer teeth; the thin wall forms a sudden change in thickness relative to the first ring end, the thin wall has good flexibility, and the other parts have good rigidity, so that the wrench can rotate around the thin wall. The connecting arm passes through the longitudinal seam and is inserted into the outer ring through hole to connect the inner ring and the outer ring into one.

[0009] In another embodiment, the nested ring assembly includes a locked state and an unlocked state; in the locked state, the outer teeth and the inner teeth engage with each other, causing the outer ring wall to move in the direction of reducing the inner diameter, thereby increasing the ring clamping force between the inner ring and the outer ring; prying the wrench outward allows the wrench to rotate around the thin wall, causing the inner teeth to rotate outward and disengage from the outer teeth, thereby changing from a locked state to an unlocked state.

[0010] In another solution, the embedded ring includes an inner ring wall and a connecting arm extending outward from the outer side of the inner ring wall. The end of the connecting arm includes a reverse buckle; the outer wrapping ring includes an outer ring wall and an outer ring through hole penetrating the ring wall; the connecting member includes a knob and a knob through hole and a knob counterbore penetrating through it; the knob counterbore includes a concave shoulder and a convex shoulder. After the connecting arm passes through the longitudinal slit and the ring through hole in sequence, the connecting member is fixed to the end of the connecting arm, wherein the reverse buckle is matched and engaged with the concave shoulder, thereby connecting the embedded ring and the outer wrapping ring into one body. Rotating the connecting member can make the convex shoulder and the reverse buckle engage with each other, thereby locally stretching the embedded ring and locally compressing the outer wrapping ring, and further locking the outer membrane around the connecting arm.

[0011] In another solution, the embedded ring includes an inner ring wall. The connecting member is integrally connected with the inner ring wall and extends laterally outward to form a connecting arm. The end of the connecting arm includes a connecting arm through hole; the outer wrapping ring includes an outer ring wall and an outer ring notch penetrating through it. The nested ring assembly further includes a cam and a fixing pin; the cam includes a wrench, a cam surface and a cam through hole. The cam surface includes a locking surface and an unlocking surface. The connecting arm passes through the longitudinal slit and the outer ring notch in sequence, and the fixing pin penetrates through the connecting arm through hole and the cam through hole to fix the cam on the connecting arm, thereby connecting the embedded ring and the outer wrapping ring into one body. The nested ring assembly includes a locked state and an unlocked state. Pull the wrench to make the cam rotate around the fixing pin until the locking surface of the cam contacts and presses the inner ring wall, thereby increasing the hoop force of the outer wrapping ring on the object wrapped inside it to achieve locking; pull the wrench to make the cam rotate around the fixing pin until the unlocking surface of the cam contacts the inner ring wall, thereby reducing the hoop force of the outer wrapping ring on the object wrapped inside it to achieve unlocking.

[0012] In another solution, the embedded ring includes an inner ring wall, and the connecting member is integrally connected with the inner ring wall and extends horizontally outward to form a connecting arm; the outer wrapping ring includes an outer ring wall and an outer ring through hole penetrating the ring wall, and the outer ring wall includes a cutting groove that completely cuts off the outer ring wall to form a first ring end and a second ring end; the first ring end includes a first outer lug and a first lug through hole penetrating it; the second ring end includes a second outer lug and a second lug through hole penetrating it. The nested ring assembly further includes a lock and a pin; the lock includes a wrench, a lock arm and an outer convex block connecting the two; the lock arm includes a first end through hole and a second middle through hole penetrating it. The connecting arm sequentially passes through the longitudinal slit and the outer ring through hole, the first end through hole of the lock is aligned with the first lug through hole and fixed with a pin, and the second middle through hole of the lock is aligned with the second lug through hole and fixed with a pin, thereby connecting the embedded ring and the outer wrapping ring into one body. The nested ring assembly includes a locked state and an unlocked state. When the outer convex block contacts the outside of the first ring end, the inner diameter of the outer wrapping ring is reduced, thereby increasing the hoop force of the outer wrapping ring on the object wrapped inside it to achieve locking; when the wrench is pulled outward to make the lock arm rotate to contact the outside of the first ring end, the inner diameter of the outer wrapping ring is increased at this time, thereby reducing the hoop force of the outer wrapping ring on the object wrapped inside it to achieve unlocking.

[0013] In another aspect of the present invention, a single-hole access device is proposed, which includes any one of the foregoing flexible retractors and also includes a sealing system; the sealing system includes a main sealing cover and a plurality of sealing tube assemblies communicated therewith; 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 that matches the shape and size of the outer ring outside the body, and the inner ring cavity forms a detachable elastic interference connection with the outer ring outside the body and forms an airtight seal. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more fully understand the essence of the present invention, the following will be described in detail with reference to the drawings, in which: Figure 1 is a three-dimensional schematic diagram of the flexible retractor 1; Figure 2 is an exploded view of the flexible retractor 1; Figure 3 is a side projection view of the incision sleeve assembly 2; Figure 4 is Figure 3 a 4-4 cross-sectional view of; Figure 5 is an exploded view of the nested ring assembly 3; Figure 6 is a three-dimensional schematic diagram of the nested ring assembly 3; Figure 7 is a side projection view of the flexible retractor 1; Figure 8 is Figure 7 the 8-8 cross-sectional view; Figure 9 is Figure 8 the enlarged view of 9-9; Figure 10 is the 3D partial cross-sectional view of the main seal cover 100; Figure 11 is the three-dimensional schematic diagram of the single-hole access device 6; Figure 12 is the three-dimensional schematic diagram of the nested ring assembly 3a; Figure 13 is the exploded view of the nested ring assembly 3a; Figure 14 is the side projection view of the connecting piece 80a; Figure 15 is Figure 14 the 15-15 cross-sectional view; Figure 16 is the exploded view of the nested ring assembly 3b; Figure 17 is the projection view of the nested ring assembly 3b from the proximal end to the distal end; Figure 18 is Figure 17 the 18-18 cross-sectional view; Figure 19 is the exploded view of the nested ring assembly 3c; Figure 20 is the projection view of the outer ring 70c from the proximal end to the distal end; Figure 21 is Figure 20 the enlarged view of 21-21; Figure 22 is the side projection view of the nested ring assembly 3c; Figure 23 is Figure 22 the 23-23 cross-sectional view; Figure 24 is the exploded view of the nested ring assembly 3d; Figure 25 is the projection view of the nested ring assembly 3d from the proximal end to the distal end; Figure 26 is Figure 25 the 26-26 cross-sectional view; Figure 27 is the exploded view of the nested ring assembly 3e; Figure 28 is the side projection view of the outer ring 70e; Figure 29 is Figure 28 the 29-29 cross-sectional view; Figure 30Yes Figure 29 30 - 30 enlarged view of Figure 31 is a three - dimensional schematic diagram of the latch 80e; Figure 32 is a three - dimensional schematic diagram of the nested ring assembly 3e; Figure 33 is a side projection view of the nested ring assembly 3e; Figure 34 is Figure 33 34 - 34 cross - sectional view of In all views, the same reference numerals denote equivalent parts or components. Detailed implementation manners

[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 content disclosed herein is not to be construed as restrictive, 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 disclosed embodiments of the present invention will now be described in detail with reference to the accompanying drawings. For 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.

[0016] Figures 1 - 2 depicts the structure and composition of a flexible retractor 1. The flexible retractor 1 includes an incision sleeve assembly 2 and a nested ring assembly 3.

[0017] As Figures 3 - 4 , the incision sleeve assembly 2 includes an in - vivo ring 10, an ex - vivo ring 20, and a thin - film conduit 30 disposed therebetween. The thin - film conduit 30 is a flexible tube made of plastic film in a long - tube shape. Its distal end 31 of the conduit intersects and is integrally connected with the extension of the in - vivo ring 10, and its proximal end 39 of the conduit intersects and is integrally connected with the extension of the ex - vivo ring 20. The incision sleeve assembly 2 further includes an outer membrane 40 attached to the outer surface of the conduit 30. In one implementation, the distal end of the outer membrane is welded to the outer surface of the conduit 30 to form a distal weld 41, the proximal end of the outer membrane is welded to the outer surface of the conduit 30 to form a proximal weld 49, and the outer membrane 40 and the conduit 30 define a diaphragm cavity 47. The outer membrane 40 further includes one or more longitudinal slits 43, and the longitudinal slits 43 divide the outer membrane 40 into a plurality of outer membrane pieces 45.

[0018] As Figures 5 - 6, the nested ring assembly 3 includes an inner nested ring 60, an outer nested ring 70, and a connecting member 80. The inner nested ring 60 includes an inner ring wall 61 and an inner ring through hole 62 penetrating the ring wall. The outer nested ring 70 includes an outer ring wall 71 and an outer ring through hole 72 penetrating the ring wall. The connecting member 80 includes a knob 81 and a connecting arm 82. The inner nested ring 60 is installed inside the outer nested ring 70, where the through holes 62 and 72 are aligned, and the connecting arm 82 of the connecting member 80 is inserted into the through holes 62 and 72 to integrally connect the inner nested ring 60 and the outer nested ring 70.

[0019] As Figure 7 , Figure 8 and Figure 9 , the inner nested ring 60 is installed in the diaphragm cavity 47, where the outer diaphragm 45 passes through the gap between the inner nested ring and the outer nested ring, and the connecting member 80 passes through the longitudinal seam 43. Those skilled in the art should understand that at least two methods can be used to assemble the flexible retractor 1: Method 1, before welding the distal weld 41 and / or the proximal weld 49, first place the inner nested ring 60 between the thin film conduit 30 and the outer film 40, and then assemble the nested ring assembly 3 after welding; Method 2, when assembling the nested ring assembly, first clamp the outer film 40 between the inner nested ring 60 and the outer nested ring 70, and then weld the outer film 40 to the outside of the thin film conduit 30.

[0020] Figures 10 - 11 Illustrated is a single-port access device 6 including a flexible retractor 1 and a sealing system 7. The sealing system 7 includes a main sealing cover 100 and a plurality of sealing tube assemblies communicating therewith. The main sealing 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 main flange includes an inner ring cavity 105 that matches the shape and size of the outer ring 20 outside the body, and the inner ring cavity forms a detachable elastic interference connection with the outer ring outside the body and forms a gas seal.

[0021] In this embodiment, the main sealing cover 100 includes four sealing tube assemblies, namely, sealing tube assemblies 111, 112, 113, and 114. However, it may also include fewer or more sealing tube assemblies. Each sealing tube assembly further includes 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 a gas seal, and the one-way valve 121 is used to automatically close when the instrument is withdrawn or no instrument is inserted, thereby preventing gas leakage.

[0022] 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.

[0023] Those skilled in the art should understand that during clinical application, the flexible retractor 1 is placed at the incision of the patient's body wall, and the inner ring 10 and the thin film conduit 30 in its adjacent area can be compressed and deformed to pass through the incision of the patient's body wall. Once the 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 inner ring 10 can automatically recover to form a substantially circular ring, and the flexible retractor 1 in its adjacent area is then pulled outwards and pressed against the inner surface of the patient's body wall incision. The muscles and tissues of the patient's incision squeeze the thin film conduit 30 inwards and force the inner diameter of the thin film conduit 30 to become smaller, thereby forming a tension in the first outer membrane and forming an approximately hourglass-shaped structure.

[0024] In a design scheme, the connecting arm 82 includes an external thread, and the inner ring through hole 62 includes an internal thread. The connecting arm 82 and the inner ring through hole 62 are matched to form a threaded connection. When the connecting piece is loosened, the nested ring assembly can be moved along the longitudinal seam, thereby shortening or lengthening the length of the thin film conduit between the outer wrapping ring and the inner ring, and further adjusting the shape and size of the hourglass-shaped thin film conduit, and further adjusting the opening size of the patient's incision.

[0025] U.S. Invention Application US20070088202A1 (hereinafter referred to as 202A1) lists various methods for adjusting the length of the incision sleeve by the flipping method. Its principle is roughly that the external ring is designed to be a semi-rigid structure, and the user holds the external ring by hand and applies a flipping torque to its interior, which can cause the external ring to be distorted and flipped, so that the thin film conduit in the adjacent area of the external ring wraps around the outer surface of the external ring. The external ring can be flipped multiple times to make the thin film conduit wrap around the external ring multiple times and in multiple layers. This method of adjusting the incision size by flipping has a relatively large force and is not suitable for female doctors or older doctors. And flipping and wrapping easily cause the thin film to accumulate and wrinkle, resulting in unreliable connection with the sealing system and air leakage.

[0026] Those skilled in the art should be able to understand that the flexible retractor 1 has at least two improvements compared to the incision sleeve disclosed in Invention Application 202A1: First, it can conveniently and quickly adjust the opening size of the patient's incision for the second or multiple times during the operation. The adjustment method is simple and fast. Just loosen the connecting piece and move the inner embedded ring and the outer wrapping ring together. There are many clinical application scenarios where the incision size of the patient needs to be adjusted for the second 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 Calot triangle. During this period, the diameter of the instruments entering the patient's body is relatively small. About 10% requires the use of thick-diameter clip appliers. At this time, it is necessary to briefly expand the patient's incision and then reduce the incision again after the clipping is completed. This is beneficial to reducing the damage to the patient's wound. However, for the incision sleeve disclosed in 202A1, the main sealing cover installed on it must be removed first, that is, after destroying the pneumoperitoneum state of the patient, the incision size can be adjusted.

[0027] Second, for the incision sleeve described in the present invention, the main sealing cover is integrated with the external ring and the thin film pipeline. When moving and swinging the instruments at various angles during the operation, it has greater deformation ability and more movement freedom. However, for the incision sleeve disclosed in 202A1, its external ring and the incision sleeve are closely attached to the patient's incision and are connected to the main sealing cover at the same time, restricting the swinging space of the instruments.

[0028] To ensure the sealing reliability between the flexible retractor 1 and the patient's incision, in one implementation solution, the distance between the distal weld 41 and the inner body ring 10 is L1, and the outer diameter of the inner body ring is D1, where L1≥0.5×D1. This setting is beneficial to avoiding the longitudinal seam air leakage caused by the outer membrane 40 pulling the patient's incision.

[0029] Figures 12 - 15 Another nested ring assembly 3a is depicted. The nested ring assembly 3a includes an inner embedded ring 60a, an outer wrapping ring 70a, and a connecting piece 80a.

[0030] As Figure 13 , the inner embedded ring 60a includes an inner ring wall 61a and a connecting arm 62a extending outward from the side of the ring wall. The end of the connecting arm 62a includes a reverse buckle 63a. Each connecting arm 62a includes one or two sector-shaped reverse buckles. In this example, each connecting arm 62a includes two sector-shaped reverse buckles, and the proportion of each sector-shaped reverse buckle in the circumferential direction of the connecting arm ≤0.25 (that is, the central angle of the reverse buckle sector ≤90°). The outer wrapping ring 70a includes an outer ring wall 71a and an outer ring through hole 72a penetrating the ring wall.

[0031] As Figures 14 - 15 , the connecting piece 80a includes a knob 81a, a knob through hole 82a penetrating it, and a knob counterbore 83a. The knob counterbore 83a includes a concave shoulder 84a and a convex shoulder 85a.

[0032] The inner ring 60a is installed inside the outer ring 70a, wherein the connecting arm 62a passes through the outer ring through hole 72a. The connecting piece 80a is fixed at the end of the connecting arm 62a, wherein the connecting arm 62a passes through the knob through hole 82a, and the undercut 63a and the concave shoulder 84a are engaged with each other, thereby connecting the inner ring 60a and the outer ring 70a into one body.

[0033] The nested ring assembly 3a has similar functions to the nested ring assembly 3. The ring assembly 3a is used to replace the ring assembly 3, and the incision sleeve assembly 2 is adaptively modified to include four longitudinal slits, thereby forming a new flexible retractor 1a (not shown in the figure). The flexible retractor 1a has similar methods of use and beneficial effects as the retractor 1. The difference lies mainly in the locking method: the connecting member 80a is rotated to make the convex shoulder 85a and the undercut 63a engage with each other, thereby locally stretching the inner ring 60a and locally compressing the outer ring 70a, thereby locking the outer membrane 40 around the connecting arm 62a, and the longitudinal slit-moving nested ring assembly cannot be moved at this time. On the contrary, when the undercut 63a and the concave shoulder 84a engage with each other, the nested ring assembly can be moved along the longitudinal slit, thereby shortening or lengthening the length of the film conduit between the outer ring and the inner body ring, thereby adjusting the shape and size of the hourglass-shaped film conduit, and thereby adjusting the opening size of the patient's incision.

[0034] The outer ring 70a can be made of TPE thermoplastic elastomer material (such as TPV / TPR / TPU / TPO, etc.) or thermosetting elastomer material (such as silicone rubber, isoprene rubber, etc.) to form a flexible or semi-rigid ring. The inner diameter of the outer ring 70a is smaller than the outer diameter of the inner ring 60a. The outer ring 70a can produce a large elastic deformation, thereby generating a certain clamping force on the outer surface of the inner ring. When the connector 80a is not locked, when the nested ring assembly is moved along the longitudinal seam, this clamping force provides appropriate friction, which is convenient for the operator to adjust.

[0035] Figures 16 - 18 Another nested ring assembly 3b is depicted. The nested ring assembly 3b includes an inner ring 60b and an outer ring 70b. The inner ring 60b includes an inner ring wall 61b and a connecting arm 62b extending outward from the side of the ring wall. The outer ring 70b includes an outer ring wall 71b and an outer ring through hole 72b penetrating the ring wall. The inner ring 60b is installed on the inner side of the outer ring 70b, wherein the connecting arm 62b passes through the outer ring through hole 72b. In this example, 4 connecting arms and 4 outer ring through holes are included, but more or less connecting arms and outer ring through holes are also suitable.

[0036] Similarly, the outer sleeve ring 70b can be made of a flexible or semi-rigid ring of TPE thermoplastic elastomer material or thermosetting elastomer material. The inner diameter of the outer sleeve ring 70b is smaller than the outer diameter of the inner embedded ring 60b. The outer sleeve ring 70b can produce a large elastic deformation, so as to generate a certain tightening force on the outer surface of the inner embedded ring.

[0037] The nested ring assembly 3b has a similar function to the nested ring assembly 3a. Replacing the ring assembly 3a with the ring assembly 3b can form a new flexible retractor 1b (not shown in the figure). The usage method and beneficial effects of the flexible retractor 1b are similar to those of the retractor 1a.

[0038] The frictional force F of the inner embedded ring assembly 3b on the outer membrane 40 sandwiched therebetween can be comprehensively considered in terms of the elastic modulus E of the outer sleeve ring 70b, the width B of the outer sleeve ring, the thickness T of the outer sleeve ring, the inner diameter D of the outer sleeve ring 3 and the outer diameter D of the inner embedded ring 2 The ratio is set by the friction coefficient u and the correction coefficient x between the inner embedded ring assembly and the outer membrane: F = xuEBTD 3 / D 2 .

[0039] Those skilled in the art should be able to understand that, based on multiple tests, the frictional force F can reach a reasonable level: when the user moves the nested ring assembly along the cylindrical outer membrane, the touch is smooth and easy; the patient's incision squeezes the outer membrane 40 of the flexible retractor 1c to form an outer membrane with an approximate hourglass shape, but the tension in the outer membrane and the elastic recovery pressure of the patient's skin are not sufficient to offset the frictional force F of the inner embedded ring assembly 3b on the outer membrane 40 sandwiched therebetween, so as to realize the locking of the nested ring assembly 3b at any position.

[0040] Figures 19 - 23 depicts yet another nested ring assembly 3c. As Figure 19 , the nested ring assembly 3c includes an inner embedded ring 60c and an outer sleeve ring 70c. The inner embedded ring 60c includes an inner ring wall 61c and a connecting arm 62c extending outward from the side of the ring wall.

[0041] As Figures 20 - 21, the outer ring 70c includes an outer ring wall 71c and an outer ring through hole 72c penetrating the ring wall. The outer ring wall 71c includes a cutting groove 73c that completely cuts off the outer ring wall 71c to form a first ring end 74c and a second ring end 75c. The first ring end 74c includes a thin wall 76c and a wrench 77c connected thereto and extending outward, the wrench 77c includes inner teeth 78c, and the second ring end 75c includes outer teeth 79c. The outer ring 70c is made of a plastic material with good toughness such as PP (polypropylene), PE (polyethylene), PA (nylon), etc. The thickness of the thin wall 76c changes suddenly, the thin wall 76c has good flexibility, and the other parts have good rigidity, so that the wrench 77c can rotate around the thin wall 76c.

[0042] like Figures 22 - 23 , the inner ring 60c is installed inside the outer ring 70c, wherein the connecting arm 62c passes through the outer ring through hole 72c. The nested ring assembly 3c includes a locked state and an unlocked state. In the locked state, the outer teeth 79c and the inner teeth 78c are engaged with each other, and this engagement causes the outer ring wall 71c to move in the direction of reducing the inner diameter, thereby increasing the ring clamping force between the inner ring 60c and the outer ring 70c. By breaking the wrench 77c outward, the wrench 77c can be rotated around the thin wall 76c, so that the inner teeth 78c rotate outward to disengage the outer teeth 79c, and the locked state is changed to the unlocked state.

[0043] The nested ring assembly 3c has similar functions to the nested ring assembly 3. The ring assembly 3 is replaced by the ring assembly 3c, and the incision sleeve assembly 2 is adaptively modified to include three longitudinal slits, which can form a new flexible retractor 1c (not shown in the figure). The flexible retractor 1c has similar usage and beneficial effects as the retractor 1: when the nested ring assembly 3c is in an unlocked state, the nested ring assembly can be moved along the longitudinal slit, thereby shortening or lengthening the length of the film tube between the outer ring and the body ring, thereby adjusting the shape and size of the hourglass-shaped film tube, and thereby adjusting the opening size of the patient's incision. When the nested ring assembly 3c is in a locked state, the longitudinal slit-moving nested ring assembly cannot be moved.

[0044] Figures 24 - 26 A further nested ring assembly 3d is depicted. The nested ring assembly 3d comprises an inner ring 60d, an outer ring 70d, a cam 80d and a fixing pin 90d.

[0045] like Figure 24, the embedded ring 60d includes an inner ring wall 61d and connecting arms 62d extending outward from the side of the ring wall. The connecting arms 62d include connecting arm through-holes 63d penetrating their ends. This embodiment includes two connecting arms, but more connecting arms can also be included. Each of the connecting arms 62d includes two bifurcations (or branches), but there can also be only one bifurcation (branch). The outer wrapping ring 70d includes an outer ring wall 71d and an outer ring notch 72d penetrating the ring wall. The cam 80d includes a wrench 81d, a cam surface 82d, and a cam through-hole 83d. The cam surface 82d includes a locking surface 84d and an unlocking surface 85d, and the locking surface is farther from the axis of the cam through-hole than the unlocking surface.

[0046] As Figures 25 - 26 , the embedded ring 60d is installed inside the outer wrapping ring 70d, where the connecting arms 62d pass through the outer ring notch 72d. The fixing pin 90d penetrates the connecting arm through-hole and the cam through-hole 83d to fix the cam 80d on the connecting arms 62d, thereby connecting the embedded ring 60d and the outer wrapping ring 70d into one body. The nested ring assembly 3d includes a locked state and an unlocked state. Pull the wrench 81d to rotate the cam 80d around the fixing pin 90d until the locking surface 84d of the cam contacts and presses the inner ring wall 61, thereby increasing the hoop force of the outer wrapping ring on the object it wraps inside, achieving locking. Pull the wrench 81d to rotate the cam 80d around the fixing pin 90d until the unlocking surface 84d of the cam contacts the inner ring wall 61, thereby reducing the hoop force of the outer wrapping ring on the object it wraps inside, achieving unlocking.

[0047] The nested ring assembly 3d is similar in function to the nested ring assembly 3. Replacing the ring assembly 3 with the ring assembly 3d can form a new flexible retractor 1d (not shown in the figure). The usage method and beneficial effects of the flexible retractor 1d are similar to those of the retractor 1: when the nested ring assembly 3d is in the unlocked state, the nested ring assembly can be moved along the longitudinal seam, thereby shortening or lengthening the length of the thin film pipeline between the outer wrapping ring and the inner ring in the body, and further adjusting the shape and size of the hourglass-shaped thin film pipeline, and further adjusting the opening size of the patient's incision. When the nested ring assembly 3d is in the locked state, the nested ring assembly cannot be moved along the longitudinal seam at this time.

[0048] Figures 27 - 34 Another nested ring assembly 3e is depicted. The nested ring assembly 3e includes an embedded ring 60e, an outer wrapping ring 70e, a latch 80e, a pin 91e, and a pin 92e.

[0049] As Figure 27 , the embedded ring 60e includes an inner ring wall 61e and connecting arms 62e extending outward from the side of the ring wall.

[0050] As Figures 28 - 30, the outer wrapping ring 70e includes an outer ring wall 71e and an outer ring through-hole 72e penetrating the ring wall. The outer ring wall 71e includes a cutting groove 73e that completely cuts off the outer ring wall 71e, forming a first ring end 74e and a second ring end 75e. The first ring end 74e includes a first outer lug 741e and a first lug through-hole 742e penetrating it; the second ring end 75e includes a second outer lug 751e and a second lug through-hole 752e penetrating it. In this example, the second outer lug includes two bifurcations (or branches), but there can also be only one bifurcation (branch).

[0051] As Figure 30 , the latch 80e includes a wrench 81e, a locking arm 82e, and an outer convex block 83e connecting the two. The locking arm 82e includes a first end through-hole 86e and a second intermediate through-hole 87e penetrating it. In this example, the end of the locking arm 82e includes two bifurcations (or branches), but there can also be only one bifurcation (branch).

[0052] As Figures 32 - 34 , the embedded ring 60e is installed inside the outer wrapping ring 70e, where the connecting arm 62e passes through the outer ring through-hole 72e. The first end through-hole 86e of the latch 80e is aligned with the first lug through-hole 742e and fixed with a pin 91e. The second intermediate through-hole 87e of the latch is aligned with the second lug through-hole 752e and fixed with a pin 92e.

[0053] The nested ring assembly 3e includes a locked state and an unlocked state. Figure 34 The locked state of the nested ring assembly 3e is depicted: when the outer convex block 83e contacts the outside of the first ring end 74e, the inner diameter of the outer wrapping ring 70e is reduced, thereby increasing the hoop force of the outer wrapping ring on the object it wraps inside, achieving locking. Combining Figure 34 Understanding, pulling the wrench 81e outward to rotate the locking arm 82e to contact the outside of the first ring end 74e. At this time, the inner diameter of the outer wrapping ring 70e is increased, thereby reducing the hoop force of the outer wrapping ring on the object it wraps inside, achieving unlocking.

[0054] The nested ring assembly 3e is similar in function to the nested ring assembly 3. Replacing the ring assembly 3 with the ring assembly 3e, the incision sleeve assembly 2 is adaptively modified to include 3 longitudinal slits, which can form a new flexible retractor 1e (not shown in the figure). The usage method and beneficial effects of the flexible retractor 1e are similar to those of the retractor 1: when the nested ring assembly 3e is in the unlocked state, the nested ring assembly can be moved along the longitudinal slits, thereby shortening or lengthening the length of the thin film pipeline between the outer wrapping ring and the in-body ring, and further adjusting the shape and size of the hourglass-shaped thin film pipeline, and further adjusting the opening size of the patient's incision. When the nested ring assembly 3e is in the locked state, the nested ring assembly cannot be moved along the longitudinal slits at this time.

[0055] Those skilled in the art should easily conceive that the features of the foregoing different embodiments can be mutually replaced and recombined, or the features in each example can be borrowed and fused to add more features, thereby forming a new implementation scheme. For example, after making adaptive modifications to the flexible outer sleeve ring 70b, it can be added between the inner sleeve ring 60c and the outer sleeve ring 70c, or between the inner sleeve ring 60d and the outer sleeve ring 70d, and between the inner sleeve ring 60e and the outer sleeve ring 70e, to generate a new nested ring assembly that has both a reasonable damping feeling (friction) and can be firmly locked. For the sake of simplicity of expression, the inner sleeve rings and outer sleeve rings shown are all circular, however, they can also be oval, polygonal and other shapes. Although the inner sleeve rings in the shown cases are all closed rings, they can also be disconnected. For example, the inner sleeve ring includes a cut-off opening, which is more convenient for assembly; under the hoop force of the outer sleeve ring, the cut-off of the inner sleeve ring closes to form a stable nested combination. Alternatively, the cut-off can also be closed by additional ultrasonic welding, heat welding or bonding. Similarly, for the convenience of assembly, the outer sleeve ring can also be first processed with a cut-off opening and then welded or bonded together.

[0056] A person of ordinary skill in the art can make adaptive improvements to the methods and instruments by appropriate modifications without departing from the scope of the present invention. As long as these modified schemes are still basically the same as the idea of the present invention when observed from an overall perspective, 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 methods and instruments by appropriate modifications without departing from the scope of the present invention. Several modified schemes have been mentioned, and for those skilled in the art, other modified schemes can also be conceived. Therefore, the scope of the present invention should be determined according to the appended claims and should not be construed as being limited by the specific contents of the structures, materials or actions shown and recorded in the specification and drawings.

Claims

1. A flexible retractor, comprising an incision sleeve assembly and a nested ring assembly, characterized in that: 1) The incision sleeve assembly comprises an inner body ring, an outer body ring and a thin film pipe arranged therebetween; the thin film pipe comprises a long cylindrical flexible tube made of a plastic film, the distal end of which is connected to the inner body ring and the proximal end of which is connected to the outer body ring; 2) The incision sleeve assembly further comprises an outer film attached to the outer surface of the film pipe, the distal end and the proximal end of the outer film are respectively welded to the outer surface of the pipe to form a weld, the outer film and the weld and the film pipe together define a diaphragm cavity, and the longitudinal seam cuts the outer film along the axial direction of the film pipe, so that the diaphragm cavity is connected to the outside; 3) The nested ring assembly comprises an inner ring, an outer ring and a connector. The inner ring is installed in the diaphragm cavity, the outer ring is installed outside the outer membrane, and the connector connects the inner ring and the outer ring into one.

2. The retractor according to claim 1, characterized in that The weld includes a proximal weld and a distal weld, the distance between the distal weld and the inner ring is L1, the outer diameter of the inner ring is D1, wherein L1≥0.5×D1.

3. The retractor according to claim 1, characterized in that: 1) The inner ring includes an inner ring wall and an inner ring through hole penetrating the ring wall; the outer ring includes an outer ring wall and an outer ring through hole penetrating the ring wall; the connecting piece includes a knob and a connecting arm; 2) The inner ring through hole, the outer ring through hole and the longitudinal seam are aligned, and the connecting arm of the connecting piece passes through the outer ring through hole and the longitudinal seam and is inserted into the inner ring through hole, so as to connect the inner embedded ring and the outer wrapping ring into one body; 3) The inner ring through hole includes an internal thread, and the connecting arm includes an external thread matching therewith. The connecting arm matches the inner ring through hole to form a threaded connection. When the threaded connection is loosened, the nested ring assembly can be moved along the longitudinal seam, thereby shortening or lengthening the length of the film pipe between the outer ring and the inner ring; when the threaded connection is locked, the nested ring assembly is locked with the outer film without generating relative movement.

4. The retractor according to claim 1, characterized in that: 1) The inner embedded ring includes an inner ring wall, the connecting piece is integrally connected with the inner ring wall and extends outward transversely to form a connecting arm, the outer wrapping ring includes an outer ring wall and an outer ring through hole penetrating the ring wall, and the connecting arm is inserted into the outer ring through hole after passing through the longitudinal slit; 2) The outer ring is made of thermoplastic elastomer material or thermosetting elastomer material to form a flexible or semi-rigid ring structure. The inner diameter of the outer ring is smaller than the outer diameter of the inner ring. The outer ring is elastically deformed, thereby exerting a certain clamping force on the outer surface of the inner ring.

5. The retractor according to claim 1, characterized in that: 1) The embedded ring includes an inner ring wall, the connecting piece is connected to the inner ring wall as a whole and extends outward laterally to form a connecting arm; the outer ring includes an outer ring wall and an outer ring through hole penetrating the ring wall, the outer ring wall also includes a cutting groove to completely cut off the outer ring wall to form a first ring and a second ring end; the first ring end includes a thin wall and a wrench connected thereto and extending outward, the wrench includes internal teeth, and the second ring end includes external teeth; the thin wall forms a sudden change in thickness relative to the first ring end, the thin wall has good flexibility, and the other parts have good rigidity, so that the wrench can rotate around the thin wall; 2) The connecting arm passes through the longitudinal slit and is inserted into the through hole of the outer ring to connect the inner ring and the outer ring into one.

6. The retractor according to claim 5, characterized in that The nested ring assembly includes a locked state and an unlocked state; in the locked state, the outer teeth and the inner teeth engage with each other, causing the outer ring wall to move in the direction of reducing the inner diameter, thereby increasing the ring clamping force between the inner embedded ring and the outer wrapping ring; prying the wrench outward allows the wrench to rotate around the thin wall, causing the inner teeth to rotate outward and disengage from the outer teeth, thereby changing from the locked state to the unlocked state.

7. The retractor according to claim 1, characterized in that: 1) The embedded ring includes an inner ring wall and a connecting arm extending outward from the outer side of the inner ring wall, and the end of the connecting arm includes an undercut; the outer ring includes an outer ring wall and an outer ring through hole penetrating the ring wall; the connecting piece includes a knob and a knob through hole and a knob countersunk hole penetrating the knob; the knob countersunk hole includes a concave shoulder and a convex shoulder; 2) After the connecting arm passes through the longitudinal seam and the ring through hole in sequence, the connecting piece is fixed to the end of the connecting arm, wherein the undercut is matched and engaged with the concave shoulder, thereby connecting the inner ring and the outer ring into one; 3) Rotating the connector can cause the boss and the undercut to engage with each other, thereby locally stretching the embedded ring and locally compressing the outer ring, thereby locking the outer membrane around the connecting arm.

8. The retractor according to claim 1, characterized in that: 1) The inner ring includes an inner ring wall, the connecting piece is integrally connected with the inner ring wall and extends outward transversely to form a connecting arm, and the end of the connecting arm includes a connecting arm through hole; the outer ring includes an outer ring wall and an outer ring notch penetrating the outer ring wall; 2) The nested ring assembly further comprises a cam and a fixing pin; the cam comprises a wrench, a cam surface and a cam through hole, and the cam surface comprises a locking surface and an unlocking surface; 3) The connecting arm passes through the longitudinal seam and the outer ring notch in sequence, and the fixing pin penetrates the connecting arm through hole and the cam through hole to fix the cam on the connecting arm, thereby connecting the inner ring and the outer ring into one.

9. The retractor according to claim 1, characterized in that: 1) The inner ring includes an inner ring wall, the connecting piece is connected to the inner ring wall as a whole and extends outward transversely to form a connecting arm; the outer ring includes an outer ring wall and an outer ring through hole penetrating the ring wall, the outer ring wall includes a cutting groove to completely cut the outer ring wall to form a first ring end and a second ring end; the first ring end includes a first outer lug and a first lug through hole penetrating therethrough; the second ring end includes a second outer lug and a second lug through hole penetrating therethrough; 2) The nested ring assembly further comprises a lock buckle and a pin; the lock buckle comprises a wrench, a lock arm and an outer protrusion connecting the two; the lock arm comprises a first end through hole and a second middle through hole penetrating therethrough; 3) The connecting arm passes through the longitudinal seam and the outer ring through hole in sequence, the first end through hole of the lock buckle is aligned with the first lug through hole and fixed with a pin, and the second middle through hole of the lock buckle is aligned with the second lug through hole and fixed with a pin, thereby connecting the inner ring and the outer ring into one.

10. A single-port access device comprising any flexible retractor according to claim 1 to claim 9, characterized in that It also includes a sealing system; the sealing system includes a main sealing cover and a plurality of sealing tube assemblies connected thereto; the main sealing cover includes 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 includes an inner ring cavity that matches the shape and size of the outer ring, and the inner ring cavity forms a detachable elastic interference connection with the outer ring and forms an airtight seal.

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