Variable stiffness carrier and system thereof

Abstract

The application discloses a variable stiffness access carrier, system, use method and application thereof, and relates to a variable stiffness access carrier, system, use method and application thereof, which comprises an inflatable air bag, an elastic folding and unfolding framework structure, a sealing film and a gas extraction pipe; the elastic folding and unfolding framework structure is internally provided with an inner cavity channel with a variable radial dimension, the sealing film is attached to both sides and an end of the elastic folding and unfolding framework structure, forming a closed inner cavity, the gas extraction pipe is connected with the closed inner cavity; the inflatable air bag is arranged in the inner cavity channel, and the inflatable air bag is provided with an inflation port at an end thereof. The tooth-shaped protruding units can realize bending with a large curvature and can adapt to the complex cavity path of a human body. The inflatable air bag can adapt to the physiological bending of a cavity of a human body, and can effectively avoid extrusion on the curved part of the cavity when a long air bag is inflated and straightened. The variable stiffness access carrier can pass through the natural cavity of a human body in a low-rigidity and small-diameter state.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of natural orifice transluminal endoscopic surgery instruments, and in particular to a variable stiffness access carrier and a system thereof. BACKGROUND

[0002] Natural Orifice Transluminal Endoscopic Surgery (NOTES) is a new research hotspot in the field of surgery after multi-port minimally invasive surgery and single-port minimally invasive surgery. In such surgery, the surgeon places the surgical instrument into the patient's abdominal or thoracic cavity through the natural orifice of the human body to perform surgical operations. Compared with other types of minimally invasive surgery, natural orifice transluminal endoscopic surgery has many advantages such as no scar on the body surface, less pain, shorter hospital stay, etc. The Global Engineering Frontier 2021 published by the Chinese Academy of Engineering lists "Flexible endoscopic minimally invasive surgery robot" as the first research frontier in the field of mechanical and transportation engineering.

[0003] However, the natural orifice of the human body has physiological characteristics such as narrow and tortuous, long and soft, making it extremely challenging to safely insert and accurately operate the NOTES instrument. In order to safely insert the natural orifice of the human body, the NOTES instrument adopts an elongated continuum structure. The current NOTES instrument has a large outer diameter, and the high-frequency friction between the NOTES instrument and the inner wall of the cavity during insertion causes severe discomfort to the patient and can easily cause complications such as mucosal rupture and bleeding. In addition, the current NOTES instrument usually only has a single stiffness, and under the action of dynamic environmental loads such as intestinal peristalsis and diagnostic and treatment operations, it is easy to have non-purpose movement and repeatedly rub the inner wall of the cavity, causing cavity wear and affecting the control accuracy.

[0004] Therefore, it is an effective way to solve the above problems by applying new principles and methods to design a serpentine tubular access carrier with radial folding and variable stiffness functions. Taking transesophageal natural orifice surgery as the research object, the serpentine tubular access carrier first enters the esophagus in a small diameter and flexible state and reaches the lesion site; then it is radially unfolded and its stiffness is controlled to lock the shape; further, the NOTES instrument is placed through the cavity and the surgical operation is completed; after the operation, the NOTES instrument and the access carrier are removed in reverse order. The access carrier can assist the NOTES instrument to achieve safe and lossless insertion, and provide physical protection, isolation and stable and reliable support. Therefore, the present application has important significance for the development of natural orifice transluminal endoscopic surgery SUMMARY

[0005] The application aims to solve the problem that the prior art generally has only a single stiffness, and is prone to non-purpose movement and repeated friction against the inner wall of the cavity under the action of dynamic environmental loads such as intestinal peristalsis and medical operations, causing cavity wear and affecting control accuracy.

[0006] In order to achieve the above-mentioned purpose, the application adopts a variable stiffness access carrier, which comprises an inflatable air bag, an elastic folding framework structure, a sealing film and a gas extraction pipe.

[0007] The elastic folding framework structure has an inner cavity passage with a variable radial dimension, the sealing film is attached to both sides and the end of the elastic folding framework structure, forming a closed inner cavity, and the gas extraction pipe is connected to the closed inner cavity; the inflatable air bag is arranged in the inner cavity passage, and the end of the inflatable air bag is provided with an inflation port; the elastic folding framework structure comprises a super-elastic nickel-titanium alloy wire and a plurality of rib folding units, and the plurality of rib folding units are sequentially connected end to end; the plurality of rib folding units are formed by the super-elastic nickel-titanium alloy wire in series; the rib folding unit comprises a tooth-shaped protruding unit and a spring steel wire; the spring steel wire is in the shape of a spiral line, the tooth-shaped protruding unit has a passage, and the spring steel wire is embedded in the passage; when the inflatable air bag is inflated and pressurized and the closed inner cavity is subjected to negative pressure, the rib folding unit is unfolded from the original spiral line to a circle under the action of the inflatable air bag.

[0008] Preferably, the tooth-shaped protruding unit comprises a plurality of teeth with a middle convex and two sides concave; the tooth-shaped protruding unit is made of silica gel casting; and the number of turns of the spring steel wire is two.

[0009] Preferably, the inflatable air bag comprises a plurality of flexible connecting units and a plurality of inflatable deformation units; the plurality of flexible connecting units and the plurality of inflatable deformation units are sequentially and spacedly connected; when inflated, the inflatable deformation unit increases in volume, and the flexible connecting unit does not change.

[0010] Preferably, the sealing film is a silica gel film.

[0011] The application further provides a variable stiffness access carrier system, which comprises a variable stiffness access carrier, an exhaust valve, a pressurized latex ball, a pressure regulating valve and a negative pressure pump; the closed inner cavity, the gas extraction pipe, the pressure regulating valve and the gas extraction device are sequentially connected; the pressurized latex ball and the inflation port are connected through a connecting pipe, and the connecting pipe is provided with the exhaust valve.

[0012] Compared with the prior art, the application has the following beneficial effects:

[0013] 1. The tooth-shaped protrusion units in the variable stiffness access carrier of the present application are distributed in a ring shape, and have good flexibility when no negative pressure is applied, can realize bending with large curvature, and can adapt to the complex cavity path of the human body.

[0014] 2. The inflatable air bag in the variable stiffness access carrier of the present application can be inflated locally, and the non-inflated part has a flexible joint function, can adapt to the physiological bending of the human body cavity, and can effectively avoid the extrusion of the long air bag when inflated and straightened on the curved part of the cavity.

[0015] 3. The variable stiffness access carrier of the present application can pass through the natural cavity of the human body in a low stiffness and small diameter state, and then expand the middle channel under the action of the inflatable air bag to provide a large diameter access channel.

[0016] 4. After the variable stiffness access carrier of the present application is expanded, it can be converted into a high stiffness state under the action of negative pressure, and the surgical tool can be safely and smoothly placed through the internal channel, which can protect the human body cavity from physical damage such as scratching and scratching by the surgical tool.

[0017] 5. The variable stiffness access carrier of the present application can recover to a small diameter and low stiffness state after the surgical tool completes the surgical operation, and can be safely withdrawn from the human body cavity without causing obvious discomfort to the patient.

[0018] 6. The variable stiffness access carrier of the present application can quickly adjust the stiffness by negative pressure, and provide stable rigid support for the surgical tool to improve the stability and accuracy of the surgical operation. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 The structure of the variable stiffness access carrier of the present application is shown.

[0020] Figure 2 The exploded structure of the variable stiffness access carrier of the present application is shown.

[0021] Figure 3 The structure of the inflatable air bag in the variable stiffness access carrier of the present application is shown.

[0022] Figure 4 The size and stiffness change of the variable stiffness access carrier of the present application is shown.

[0023] Figure 5 The structure of the variable stiffness access carrier system of the present application is shown.

[0024] Figure 6 The flow chart of the use method of the variable stiffness access carrier of the present application is shown.

[0025] Figure 7The application shows a schematic diagram of the application of the variable stiffness access carrier.

[0026] Element number explanation:

[0027] 1 access carrier; 2 surgical tool; 1-1 inflatable balloon; 1-2 elastic folding framework structure; 1-3 sealing membrane; 1-4 exhaust valve; 1-5 pressurized latex ball; 1-6 pressure regulating valve; 1-7 negative pressure pump; 1-8 air exhaust pipe; 1-1-1 flexible connection unit; 1-1-2 inflatable deformation unit; 1-2-1 tooth-shaped protrusion unit; 1-2-2 spring wire; 1-2-3 super-elastic nickel-titanium alloy wire. DETAILED DESCRIPTION

[0028] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0029] Embodiment one: a variable stiffness access carrier, comprising an inflatable balloon, an elastic folding framework structure, a sealing membrane and an air exhaust pipe; the elastic folding framework structure has an inner cavity passage with variable radial dimension, the sealing membrane is attached to both sides and the end of the elastic folding framework structure, forming a closed inner cavity, and the air exhaust pipe is connected to the closed inner cavity; the inflatable balloon is arranged in the inner cavity passage, and the inflatable balloon has an inflation port at the end. As shown in the figure, the inflatable balloon 1-1 is placed in the middle passage of the access carrier, the inflatable balloon 1-1 is inflated and pressurized by the pressurized latex ball 1-5, and the access carrier can be unfolded to a large diameter state under the action of the inflatable balloon 1-1 and self-adapted to the shape of the human digestive tract. The air exhaust pipe 1-8 is connected to the negative pressure pump 1-7, the negative air pressure of the closed inner cavity formed by the sealing membrane 1-3 is controlled by the pressure regulating valve 1-6, so as to adjust the static friction force between the elastic folding framework structure 1-2, and the stiffness of the access carrier changes. Figure 1

[0030] ​The elastic folding framework structure comprises super-elastic nickel-titanium alloy wires and a plurality of rib folding units, the plurality of rib folding units are sequentially connected end to end, and the plurality of rib folding units are formed in series by the super-elastic nickel-titanium alloy wires. The rib folding unit comprises a tooth-shaped protruding unit and a spring steel wire; the spring steel wire is in a spiral line shape, the tooth-shaped protruding unit has a channel, and the spring steel wire is embedded in the channel. The tooth-shaped protruding unit comprises a plurality of teeth with a middle convex and two sides concave; the tooth-shaped protruding unit is made of silica gel pouring; the number of turns of the spring steel wire is two. The inflatable air bag comprises a plurality of flexible connecting units and a plurality of inflatable deformation units; the plurality of flexible connecting units and the plurality of inflatable deformation units are sequentially and spacedly connected; when inflated, the inflatable deformation unit has a larger volume, and the flexible connecting unit does not change. The sealing film is a silica gel film. As shown in Figure 2 The sealing film 1-3, which constitutes a closed inner cavity, wraps the elastic folding framework structure 1-2. The elastic folding framework structure 1-2 is composed of super-elastic nickel-titanium alloy wires 1-2-3 in series with a plurality of rib folding units. The rib folding unit is composed of a tooth-shaped protruding unit 1-2-1 with a middle drum and two sides flat and a spring steel wire 1-2-2. The spring steel wire 1-2-2 is in a spiral line shape, and the tooth-shaped protruding unit 1-2-1 has a channel in the middle which can embed the spring steel wire 1-2-2. The tooth-shaped protruding unit 1-2-1 is made of silica gel pouring, which can avoid scratching the inner wall of the natural cavity during placement.

[0031] As shown in Figure 3 The size of the internal passage of the access carrier can be controlled by the inflatable air bag 1-1. The sealing film 1-3 is made of silica gel and has strong ductility, which can be stretched and deformed under the action of the inflatable air bag 1-1. The inflatable air bag 1-1 is composed of inflatable deformation units 1-1-2 and flexible connecting units 1-1-1. When inflated and pressurized, only the inflatable deformation unit 1-1-2 has a larger volume, while the flexible connecting unit 1-1-1 does not change, which can effectively avoid the excessive extrusion of the curved part of the natural cavity of the human body caused by the overall straightening of the long air bag when inflated and pressurized.

[0032] As shown in Figure 4As shown, when the inflatable air bag 1-1 is not inflated and pressurized and no negative pressure is applied, the rib unfolding unit is in a spiral line shape and is distributed in series in the closed inner cavity formed by the sealing film 1-3, and the rib unfolding unit has sufficient space to move relative to each other, at this time, the access carrier is in a small diameter and low stiffness state, and has good flexibility, which can adapt to the natural shape of the human body curved and variable cavity; when the inflatable air bag 1-1 is inflated and pressurized and negative pressure is applied to the closed inner cavity, the rib unfolding unit is expanded from the original spiral line shape to a circular shape under the action of the inflatable air bag 1-1, and the size of the inner cavity space is increased, under the action of negative pressure, the gas in the closed inner cavity is extracted, the sealing film 1-3 is tightly attached to the elastic folding framework structure 1-2, the rib unfolding unit is pressed against each other, the tooth-shaped protruding unit 1-2-1 is arranged in a staggered and crossed manner and is attached to each other, the friction force between them is increased, at this time, the access carrier is in a large diameter and high stiffness state, which can provide a safe channel and rigid support for the insertion and operation of surgical instruments.

[0033] Embodiment two: a variable stiffness access carrier system, characterized in that it comprises the above-mentioned variable stiffness access carrier, an exhaust valve, a pressurized latex ball, a pressure regulating valve and a negative pressure pump; the closed inner cavity, the exhaust pipe, the pressure regulating valve and the exhaust device are sequentially communicated; the pressurized latex ball and the inflation port are connected through a connecting pipe, and the connecting pipe is provided with the exhaust valve. Figure 5 As shown, the variable stiffness access carrier system is composed of an inflatable air bag 1-1, an elastic folding framework structure 1-2, a sealing film 1-3, an exhaust valve 1-4, a pressurized latex ball 1-5, a pressure regulating valve 1-6 and a negative pressure pump 1-7. The elastic folding framework structure 1-2 is arranged in the closed inner cavity formed by the sealing film 1-3, the inflatable air bag 1-1 can be inflated and pressurized by manually pressing the pressurized latex ball 1-5, and the negative pressure pump 1-7 can form a negative gas pressure in the closed inner cavity, so that the elastic folding framework structure 1-2 in the closed inner cavity is pressed tightly against each other, and the stiffness of the access carrier is increased.

[0034] Embodiment three: a variable stiffness access carrier using method, comprising the steps of:

[0035] S1, in a natural state, the access carrier is in a low stiffness and small diameter state, and is inserted into the human body cavity; the access carrier can flexibly and passively adapt to the shape of the human body cavity and reach the lesion, and the access process will not cause obvious discomfort to the patient.

[0036] S2, inflate and pressurize the inflatable air bag in the middle channel, and expand the middle channel of the access carrier by the inflatable air bag, so that the access carrier is locally expanded and presents a large diameter state;

[0037] S3, apply negative pressure to the closed inner cavity, and control the stiffness of the access carrier through the pressure regulating valve, so that the access carrier can maintain its diameter state;

[0038] S4, release the inflation balloon internal gas, in the case of the access carrier maintaining its diameter state, move the inflation balloon and re-inflate and pressurize, so that the access carrier can adapt to the digestive tract path and make the non-deployed part to be deployed under the inflation balloon effect, while maintaining its diameter state after deployment under the action of negative pressure;

[0039] S5, adjust the pressure regulating valve to make the closed internal cavity negative pressure pressure maximum, the access carrier is in a high stiffness state, and the large diameter state of the internal cavity channel of the access carrier is maintained;

[0040] S6, release the inflation balloon internal gas and separate it from the access carrier, the access carrier can provide a large diameter channel that adapts to the natural cavity shape; under the action of negative pressure, the rib folding unit can make the access carrier maintain a stable spatial shape, and the radial size of the middle channel is no longer affected by the inflation balloon. At this time, the inflation balloon is extracted, and the access carrier will maintain the state of supporting the human cavity.

[0041] S7, insert the NOTES instrument through the hollow channel of the access carrier to perform surgical operation; during the insertion of the surgical tool, the access carrier can protect the cavity tissue from physical damage such as puncture and scratch caused by the surgical tool. During the execution of the surgical operation, the access carrier can play a supporting role.

[0042] S8, after the operation is completed, the NOTES instrument is withdrawn and the negative pressure of the closed internal cavity is removed, under the action of the elastic recovery force of the spring steel wire inside the elastic folding skeleton structure, the access carrier returns to a low stiffness and small diameter state. After the operation is completed, the surgical tool is withdrawn from the access carrier. Then, the negative pressure pump is turned off and the air pressure of the closed chamber is gradually restored to atmospheric pressure state through the pressure regulating valve. At this time, the extrusion between the tooth-shaped units disappears, and the access carrier can return to the initial small diameter and low stiffness state under the action of the elastic recovery force of the silicone.

[0043] In addition, the embodiment also includes subsequent steps:

[0044] S9: withdraw the access carrier from the human natural cavity. In a natural state, the access carrier is in a low stiffness and small diameter state, and the access carrier can be smoothly withdrawn from the natural cavity, and the withdrawal process will not cause obvious discomfort to the patient.

[0045] Embodiment four: application of a variable stiffness access carrier, characterized in that the variable stiffness access carrier of claims 1-6 is used, the variable stiffness access carrier system of claim 7 is used, and the use method of the variable stiffness access carrier of claim 8 is used to send surgical instruments into the lesion and perform surgery. For example, Figure 7As shown, when the surgical instrument is inserted into the access carrier, the access carrier is in a large-diameter, high-rigidity state, and the surgical instrument is inserted completely without damaging the natural cavity of the human body, so the surgical instrument only needs to be inserted to safely reach the lesion. After the operation is completed, the surgical instrument can safely and smoothly return to the original path, and then the access carrier is restored to a small-diameter, low-rigidity state and the access carrier is withdrawn, at which time the entire surgical procedure is completed.

[0046] The variable rigidity access carrier, system, use method and application provided by the present application can realize large-curvature bending and adapt to the complex cavity environment of the human body. After entering the cavity of the human body, the inflation air bag can be self-adapted to the physiological bending of the cavity and expanded to a large-diameter state, and the access carrier is changed to a high-rigidity state by adjusting the negative pressure of the closed inner cavity. Thus, a stable and safe access path is provided for the surgical tool. During the access process, the access carrier can protect the cavity tissue of the human body from being physically damaged by the surgical tool, such as being poked and scratched. During the operation, the access carrier can provide stable support for the surgical instrument to ensure the safe operation of the surgical operation. After the operation is completed, the access carrier can be restored to a small-diameter, low-rigidity state, so as to be safely withdrawn from the cavity of the human body.

[0047] The above is only a preferred specific embodiment of the present application, but the protection scope of the present application is not limited thereto. Any person skilled in the art can make equivalent replacements or changes to the technical solution and the inventive concept of the present application within the technical range disclosed by the present application, which should be covered within the protection scope of the present application.

Claims

1. A variable stiffness access carrier, characterized by, The inflatable air bag, the elastic folding framework structure, the sealing film and the air extraction pipe are included. The elastic folding framework structure has an inner cavity channel with variable radial dimension, and the sealing film is attached to both sides and the end of the elastic folding framework structure to form a closed inner cavity, and the air extraction pipe is connected to the closed inner cavity; the inflatable air bag is arranged in the inner cavity channel, and the inflatable air bag is provided with an inflation port at the end; the elastic folding framework structure includes a super-elastic nickel-titanium alloy wire and a plurality of rib folding units, and the plurality of rib folding units are sequentially connected in a head-to-tail manner; the plurality of rib folding units are formed by the super-elastic nickel-titanium alloy wire in series; the rib folding unit includes a tooth-shaped protruding unit and a spring steel wire; the spring steel wire is in a spiral line shape, the tooth-shaped protruding unit has a channel, and the spring steel wire is embedded in the channel; when the inflatable air bag is inflated and pressurized and the closed inner cavity is subjected to negative pressure, the rib folding unit is unfolded from the original spiral line shape to a circular shape under the action of the inflatable air bag.

2. The variable stiffness access carrier of claim 1, wherein, The tooth-shaped protruding unit includes a plurality of teeth with intermediate protrusions and two recesses on both sides; the tooth-shaped protruding unit is made of silica gel casting; the number of turns of the spring steel wire is two.

3. The variable stiffness access carrier of claim 1, wherein, The inflatable air bag includes a plurality of flexible connection units and a plurality of inflatable deformation units; the plurality of flexible connection units and the plurality of inflatable deformation units are sequentially and spacedly connected; when inflated, the inflatable deformation unit increases in volume, and the flexible connection unit does not change.

4. The variable stiffness access carrier of claim 1, wherein, The sealing film is a silica gel film.

5. A variable stiffness access carrier system, characterized by, The variable stiffness access carrier, the exhaust valve, the pressurized latex ball, the pressure regulating valve and the negative pressure pump are included. The closed inner cavity, the air extraction pipe, the pressure regulating valve and the air extraction device are sequentially connected. The pressurized latex ball and the inflation port are connected through a connecting pipe, and the connecting pipe is provided with the exhaust valve.

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