WO2024088089A1 - Adjustable postoperative safety tube and method for using same, and medical observation passage forming assembly - Google Patents

Abstract

An adjustable postoperative safety tube (1) and a method for using same, and a medical observation passage forming assembly (8100). The adjustable postoperative safety tube (1) is configured to be inserted into a surgical fistula (2) after surgery, and comprises: a safety tube body (10), wherein the safety tube body (10) is prepared from degradable material, and the safety tube body (10) is configured to define a safety passage (100) in the surgical fistula (2); an inner extension portion (20), wherein the inner extension portion (20) is connected to a front end of the safety tube body (10), and an in vivo opening (101) of the safety passage (100) is located at the head of the inner extension portion (20); and an adjustable component (30), wherein the adjustable component (30) comprises a limiting member (31), which is installed at a rear end of the safety tube body (10) and adjustable in terms of position and is configured to restrictively change, by adjusting the installation position of the limiting member (31), the length of the safety tube body (10) allowed to be inserted into the surgical fistula (2), so as to meet the requirements of different populations.

Description

Adjustable postoperative safety tube and use method thereof and a medical observation channel forming component Technical Field

The invention relates to the technical field of medical equipment and supplies, in particular to an adjustable postoperative safety tube and a use method thereof and a medical observation channel forming component.

Background technique

In existing clinical applications, during surgeries such as prostate hyperplasia surgery, ureteroscopy surgery, or bladder cancer surgery, a catheter is usually inserted into the bladder through a natural human channel (such as the human urethra) to drain urine; that is, the catheter, as a medical product for inserting the catheter into the bladder through the urethra to drain urine, has been widely used in clinical medicine. However, when performing surgery on organs such as the kidneys or liver and gallbladder (such as percutaneous nephroscopy or percutaneous hepatocholangioscopy, etc.), since it is impossible to directly insert the corresponding organs through the natural channels of the human body, the doctor will construct a surgical fistula during the operation, and then insert a drainage tube into the surgical fistula for drainage. It is understandable that this surgical fistula constructed during the operation is not a natural human channel. After the operation, as time passes, the surgical fistula will gradually heal until the fistula disappears.

At present, after the operation is completed through the surgical fistula, if the postoperative bleeding is small, the doctor will place hemostatic gauze or other methods at the wound position of the surgical fistula after the tube is removed to stop bleeding, in the hope that the wound will heal as soon as possible and reduce infection. However, the future is always unknown. If after a period of time after the operation, it is found that the operation is not good and a secondary operation is required on organs such as the kidney or liver and gallbladder, the doctor will need to reinsert the relevant instruments from the wound position that may have healed to re-construct the surgical channel (i.e., the surgical fistula), which is very painful for the patient. If the drainage tube is retained in the surgical fistula for a long time after the operation, the surgical fistula will gradually shrink when the wound heals, so the drainage tube will hinder the contraction of the fistula, thereby hindering the healing of the wound, increasing the risk of wound infection, and is not conducive to the rapid recovery of the patient. In addition, since taller or fatter patients need longer catheters, while shorter or thinner patients need shorter catheters, the existing catheters are usually designed to be long enough to meet the needs of different groups of people. However, although the existing urinary catheter is provided with an air bag structure at its head to prevent it from sliding outward and falling off, it is easy to slide inward along the natural passage of the human body so that the head touches the inner wall of the organ, causing adverse effects or injuries to the patient's body.

For some animals with lesions in the internal organs, it is necessary to create at least one surgical channel AO (refer to Figure 21) connected to the outside world on the animal to facilitate the subsequent treatment of the diseased internal organs. Especially in the field of human medical treatment, in existing surgical operations, after the surgical channel AO is created, a wound connected to the surgical channel AO is usually formed on the patient. In order to prevent the surgical channel AO from being infected, medical staff will plug gauze in the wound for hemostasis, but such hemostasis is often not effective, and even tissue deterioration and aggravation may occur due to unsatisfactory hemostasis. For the recovery of the patient's internal organs, it is usually necessary to wait for a scheduled recovery period after surgery to know the effect of the operation. The recovery period of some internal organ surgeries is as long as several months. During this period, since the patient has the ability to heal the wound by himself, the previously created channel may have been partially closed before the recovery period expires. If the patient finds that the recovery of the internal organs is not ideal during this period and needs another operation, the closed surgical channel AO needs to be opened again. In this way, the patient will suffer the pain of a second operation.

In addition, since the gauze plugged in the wound has no auxiliary fixation, once the patient makes a certain range of movement, the gauze plugged in the wound is easy to fall off. In this way, the tissue corresponding to the surgical channel AO on the patient may be infected, which will bring certain potential threats to the patient's health.

Summary of the invention

One advantage of the present invention is that it provides an adjustable postoperative safety tube and method thereof, which can provide a safe channel for secondary surgery within a period of time without hindering wound healing, avoiding the reconstruction of the surgical fistula and causing harm to the patient.

Another advantage of the present invention is to provide an adjustable postoperative safety tube and method thereof, wherein, in one embodiment of the present invention, the adjustable postoperative safety tube can be selectively degraded so as to assist wound healing by degradation while retaining a safety channel.

Another advantage of the present invention is to provide an adjustable postoperative safety tube and method thereof, wherein, in one embodiment of the present invention, the adjustable postoperative safety tube can adjust and limit the length of the surgical fistula to meet the needs of different patients. For example, for a fatter patient, the The length of the adjustable postoperative safety tube inserted into the surgical fistula is longer, while for thinner patients, the length of the adjustable postoperative safety tube inserted into the surgical fistula is shorter.

Another advantage of the present invention is to provide an adjustable postoperative safety tube and method thereof, wherein, in one embodiment of the present invention, the adjustable postoperative safety tube can change and limit the length inserted into the surgical fistula by adjusting the installation position of the limiter on the safety tube body.

Another advantage of the present invention is to provide an adjustable postoperative safety tube and method thereof, wherein, in one embodiment of the present invention, the adjustable postoperative safety tube can swell when in contact with liquid to closely contact the inner wall of the surgical fistula, thereby achieving a hemostatic effect.

Another advantage of the present invention is that it provides an adjustable postoperative safety tube and method thereof. In one embodiment of the present invention, the adjustable postoperative safety tube can not only facilitate the construction of a secondary channel, but also can guide the body's fluid out of the body for observation by the doctor, so as to accurately judge the body's situation and help the doctor make a reasonable medical plan.

Another advantage of the present invention is that it provides an adjustable postoperative safety tube and method thereof. In one embodiment of the present invention, the adjustable postoperative safety tube can be fixed by bending the end, which can not only prevent the safety tube from accidentally falling off, but also prevent the end of the safety tube from causing adverse stimulation to the organ.

Another advantage of the present invention is to provide an adjustable postoperative safety tube and method thereof, wherein, in one embodiment of the present invention, the adjustable postoperative safety tube can disperse accumulated liquid or particles through multiple drainage grooves to reduce channel blockage by diversion.

Another advantage of the present invention is that it provides an adjustable postoperative safety tube and method thereof. In one embodiment of the present invention, the adjustable postoperative safety tube can be passed through a guide member so that it can be switched from a bent state to a straight state under the guidance of the guide member, which helps to take and place the safety tube in the surgical fistula.

Another advantage of the present invention is to provide an adjustable postoperative safety tube and method thereof, wherein, in order to achieve the above advantages, no complicated structure or design is required in the present invention. Therefore, the present invention successfully and effectively provides a solution, not only providing a simple adjustable postoperative safety tube and method thereof, but also increasing the practicality and reliability of the adjustable postoperative safety tube and method thereof.

One advantage of the present invention is that it provides a medical observation channel forming component, wherein the medical observation channel forming component can keep the surgical channel unobstructed during the patient's recovery period without affecting the patient's self-healing, wherein the medical observation channel forming component can not only ensure the unobstructed surgical channel, but also assist the patient's wound self-healing, thereby avoiding secondary infection at the patient's surgical channel.

Another advantage of the present invention is that it provides a medical observation channel forming component, wherein the medical observation channel forming component can be left in the patient's surgical channel for a long time, so as to facilitate timely follow-up treatment when the patient's internal organs do not recover ideally, wherein the medical observation channel forming component can be directly removed after the patient's internal organs recover, and will not cause damage to the patient during the removal.

Another advantage of the present invention is that it provides a medical observation channel forming component, wherein the medical observation channel forming component can form an observation channel, wherein the observation channel can also export tissue fluid from the postoperative internal organs, so that auxiliary medical personnel can judge the recovery of the postoperative internal organs based on the exported tissue fluid.

Another advantage of the present invention is to provide a medical observation channel forming component, wherein the medical observation channel forming component can stop the continuous bleeding of the tissue forming the surgical channel on the patient.

Another advantage of the present invention is to provide a medical observation channel forming component, wherein the medical observation channel forming component can be stably maintained in the surgical channel and is difficult to deviate from a preset posture.

Another advantage of the present invention is that it provides a medical observation channel forming component, wherein the medical observation channel forming component can separate the tissue fluid in the normal part of the patient and the tissue fluid overflowed from the patient's internal organs. In this way, the content of the tissue fluid exported by the medical observation channel forming component can be guaranteed, thereby enabling medical staff to make a more accurate judgment on the recovery results.

One advantage of the present invention is that it provides a medical observation channel forming component, wherein the observation channel formed by the medical observation channel forming component can be blocked to prevent external bacteria and other contamination sources from entering the patient's internal organs when there is no need to observe the recovery of the patient's internal organs.

Another advantage of the present invention is to provide a medical observation channel forming component, wherein the medical observation channel forming component can be inserted and removed along the surgical channel, and will not cause the patient the pain of a second operation during the insertion and removal process.

Another advantage of the present invention is to provide a medical observation channel forming component, wherein the medical observation channel forming component has a guide member to form a guide line between the patient's postoperative internal organs and the wound on the patient's body to guide the medical observation channel forming component The surgical channel is inserted.

Another advantage of the present invention is that it provides a medical observation channel forming component, wherein the medical observation channel forming component has a simple structure and low manufacturing cost, and is suitable for wide application in surgical operations.

In order to achieve at least one of the above advantages or other advantages and purposes, the present invention provides an adjustable postoperative safety tube for inserting into a surgical fistula after surgery, wherein the adjustable postoperative safety tube comprises:

A safety tube body, wherein the safety tube body is made of a degradable material and is used to define a safety passage in the surgical fistula;

an inner extension, wherein the inner extension is connected to a front end of the safety tube body, and an inner opening of the safety channel is located at a head of the inner extension; and

An adjustable component, wherein the adjustable component includes a limiter mounted in an adjustably mounted position on the rear end of the safety tube body, and is used to restrictively change the length of the safety tube body that is allowed to be inserted into the surgical fistula by adjusting the mounting position of the limiter.

In the adjustable postoperative safety tube according to the present application, the limiter of the adjustable component includes a sleeve portion adjustably sleeved on the safety tube body and a stopper portion extending outwardly and laterally from the sleeve portion.

In the adjustable postoperative safety tube according to the present application, the sleeve portion of the limiting member is interference fit with the safety tube body.

In the adjustable postoperative safety tube according to the present application, the stopper further includes a fastener, and the fastener is used to fix the sleeve portion at a predetermined position of the safety tube body.

In the adjustable postoperative safety tube according to the present application, the stop portion of the limit member extends outward integrally from the front end of the sleeve portion, and the fastener is screwed to the rear end of the sleeve portion to increase the squeezing force of the sleeve portion on the safety tube body through the fastener.

In the adjustable postoperative safety tube according to the present application, the limiting member further includes a cushion member, wherein the cushion member is disposed between the sleeve portion and the safety tube body to increase the friction force between the sleeve portion and the safety tube body.

In the adjustable postoperative safety tube according to the present application, the fastener includes an annular base, an outer peripheral arm extending integrally from the outer periphery of the annular base, and an inner peripheral arm extending integrally from the inner periphery of the annular base, wherein the outer peripheral arm and the inner peripheral arm extend longitudinally in the same direction from the annular base to form a fastening groove between the outer peripheral arm and the inner peripheral arm that is compatible with the rear end of the sleeve part, and when the rear end of the sleeve part is inserted into the fastening groove of the fastener for threaded connection, the inner peripheral arm of the fastener extends into the gap between the sleeve part and the safety tube body to contact the gasket.

In the adjustable postoperative safety tube according to the present application, the inner peripheral arm of the fastener has an inclined end surface facing the safety tube body, and when the fastener is screwed together with the sleeve portion, the inclined end surface of the inner peripheral arm abuts against the side surface of the cushion to squeeze the cushion toward the safety tube body.

In the adjustable postoperative safety tube according to the present application, the adjustable component further includes a blocking piece suitable for blocking the in vitro opening of the safety channel, and the blocking piece is flexibly connected to the stop portion of the limiting piece.

In the adjustable postoperative safety tube according to the present application, the adjustable component further includes a blocking piece suitable for blocking the extracorporeal opening of the safety channel, and the blocking piece is integrally connected to the sleeve portion of the limiting member, wherein the blocking piece is located inside the sleeve portion, so that the adjustable component has a cap-like structure, and the blocking piece is interference fit with the safety tube body.

In the adjustable postoperative safety tube according to the present application, the adjustable component further includes an adhesive layer, and the adhesive layer is disposed on the front side of the stop portion of the limiting member.

In the adjustable postoperative safety tube according to the present application, hemostatic drugs and/or anti-infective drugs are added to the safety tube body during the preparation process of the degradable material.

In the adjustable postoperative safety tube according to the present application, the degradable material used to prepare the safety tube body is a water-swellable material; or, in the process of preparing the safety tube body from the degradable material, the water-swellable material is added.

In the adjustable postoperative safety tube according to the present application, the inner extension portion extends straightly forward from the front end of the safety tube body.

In the adjustable postoperative safety tube according to the present application, the inner extension portion has an insertion state and a fixed state, wherein the inner extension portion extends in a curved manner from the front end of the safety tube body in a natural state to be in the fixed state; and the inner extension portion is suitable for straightening forward from the front end of the safety tube body under the guidance of the guide member to be in the insertion state.

In the adjustable postoperative safety tube according to the present application, the inner extension portion further has at least one drainage groove, wherein the groove of the drainage groove The opening is located on the peripheral side wall of the inner extension portion, and the notch of the drainage groove is connected to the safety passage.

In the adjustable postoperative safety tube according to the present application, the adjustable postoperative safety tube further includes an airbag assembly, wherein the airbag assembly includes an airbag cavity arranged between the inner extension portion and the safety tube body and an inflation pipe extending along the safety tube body and connected to the airbag cavity, wherein the airbag assembly has an inflated state and an uninflated state, in the inflated state, the airbag cavity expands so that the surface of the airbag cavity protrudes from the surface of the safety tube body, and in the uninflated state, the airbag cavity contracts so that the surface of the airbag cavity is consistent with the surface of the safety tube body.

The tube body of the inflation conduit of the airbag assembly of the adjustable postoperative safety tube is integrally connected to the inner wall of the safety tube body.

According to another aspect of the present application, a method for using an adjustable postoperative safety tube is provided, comprising the steps of:

Inserting an adjustable postoperative safety tube into the surgical fistula, so that the inner extension of the adjustable postoperative safety tube is located in the internal organ;

Adjusting the installation position of the adjustable component of the adjustable postoperative safety tube on the safety tube body of the adjustable postoperative safety tube to restrictively change the length of the safety tube body that is allowed to be inserted into the surgical fistula; and

The safety tube body is degraded so that the outer diameter of the safety tube body decreases as the surgical fistula tract heals and shrinks.

In the method for using the adjustable postoperative safety tube according to the present application, before the step of degrading the safety tube body so that the outer diameter of the safety tube body decreases as the surgical fistula heals and shrinks, the method further comprises the following steps:

The safety tube is expanded so that the outer diameter of the safety tube becomes larger to match the initial inner diameter of the surgical fistula.

The present invention provides a medical observation channel forming component, characterized in that the medical observation channel forming component includes a main body, wherein the main body has an inner end and an outer end, wherein the main body has a non-degradable portion and a radially deformable portion coated on the outside of the non-degradable portion, wherein the non-degradable portion forms an observation channel between the inner end and the outer end, and an inner port and an outer port, both of which are connected to the observation channel, are respectively formed at the inner end and the outer end.

According to an embodiment of the present invention, the radially deformable portion is implemented as a degradable portion, wherein the degradable portion is implemented as a material that can be absorbed by a biological body.

According to one embodiment of the present invention, the radially deformable portion is implemented as at least one expansion bladder, wherein the expansion bladder forms a cavity, wherein the expansion bladder is coated on the outside of the non-degradable portion, and wherein the radial size of the expansion bladder is configured to vary with the amount of fluid filled into the cavity.

According to an embodiment of the present invention, a direction in which the cavity extends between the inner end and the outer end is coaxial with a direction in which the non-degradable portion extends.

According to an embodiment of the present invention, a bendable section is formed on the main body between the inner end portion and a predetermined position away from the inner end portion, and the bendable section is configured to be bendable in a natural state.

According to an embodiment of the present invention, an anti-blocking groove is formed on the main body between the inner end portion and a predetermined position away from the inner end portion, and the anti-blocking groove is arranged to be connected to the observation channel.

According to one embodiment of the present invention, at least one expandable stop portion is formed on the circumferential side of the main body at a predetermined distance from the inner end portion, and the stop portion forms a fluid cavity, wherein the stop portion is configured to radially expand to a radial size greater than the radial size of other portions of the main body after a predetermined amount of fluid is injected into the fluid cavity, and radially contract to a radial size smaller than the radial size of other portions of the main body after the fluid in the fluid cavity is discharged.

According to one embodiment of the present invention, at least one expandable stop portion is formed on the circumferential side of the main body at a predetermined distance from the inner end portion, and the stop portion forms a fluid cavity, wherein the stop portion is configured to radially expand to a radial size greater than the radial size of other parts of the main body after a predetermined amount of fluid is injected into the fluid cavity, and radially contract to a radial size smaller than the radial size of other parts of the main body after the fluid in the fluid cavity is discharged, and the fluid cavity is configured to be connected to the cavity body.

According to an embodiment of the present invention, the degradable portion is made of a material that is absorbable by a living body and can swell by absorbing liquid.

According to one embodiment of the present invention, at least one expansion bladder is arranged between the degradable part and the non-degradable part, wherein the expansion bladder forms a cavity, wherein the radial dimension of the expansion bladder is arranged to change with the amount of fluid filled into the cavity, so as to drive the degradable part coated on the outside of the expansion bladder to move radially.

According to an embodiment of the present invention, at least one supporting portion is provided between the outer wall of the expansion bladder and the degradable portion, the inner side of the supporting portion is connected to the outer wall of the expansion bladder, and the outer side of the supporting portion is connected to the degradable portion, and the strength of the supporting portion is greater than that of the degradable portion. The strength of the solution.

According to an embodiment of the present invention, the medical observation channel forming component includes a protective member, wherein the protective member is detachably covered on the outer wall of the main body.

According to an embodiment of the present invention, at least two pre-tear marks are formed between two ends of the protective member.

According to an embodiment of the present invention, a partition is formed between two adjacent pre-tear lines, wherein the outer end of each of the partitions is respectively connected to a force applying arm.

Further objects and advantages of the present invention will be fully apparent from an understanding of the following description and the accompanying drawings.

These and other objects, features and advantages of the present invention will be more fully understood from the following detailed description, accompanying drawings and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

By describing the embodiments of the present application in more detail in conjunction with the accompanying drawings, the above and other purposes, features and advantages of the present application will become more apparent. The accompanying drawings are used to provide a further understanding of the embodiments of the present application and constitute a part of the specification. Together with the embodiments of the present application, they are used to explain the present application and do not constitute a limitation of the present application. In the accompanying drawings, the same reference numerals generally represent the same components or steps.

FIG1 is a perspective schematic diagram of an adjustable postoperative safety tube in a fixed state according to an embodiment of the present invention.

FIG. 2 is a schematic three-dimensional cross-sectional view of the adjustable postoperative safety tube according to the above embodiment of the present invention.

FIG3 shows a schematic diagram of assembling the adjustable postoperative safety tube according to the above embodiment of the present invention.

FIG. 4 is a schematic diagram showing a process of creating a surgical fistula before using the adjustable postoperative safety tube according to the above embodiment of the present invention.

FIG. 5 is a schematic diagram showing the insertion process of the adjustable postoperative safety tube according to the above embodiment of the present invention.

FIG. 6 is a schematic diagram showing the expansion process of the adjustable postoperative safety tube according to the above embodiment of the present invention.

FIG. 7 is a schematic diagram showing the degradation process of the adjustable postoperative safety tube according to the above embodiment of the present invention.

FIG. 8 shows a first modified implementation of the adjustable postoperative safety tube according to the above embodiment of the present invention, wherein the inner extension portion of the adjustable postoperative safety tube is in a fixed state.

FIG9 shows a schematic three-dimensional cross-sectional view of the adjustable postoperative safety tube according to the first variant embodiment of the present invention, wherein the inner extension portion of the adjustable postoperative safety tube is in an inserted state.

FIG. 10 shows a schematic diagram of the application of the adjustable postoperative safety tube according to the first variant embodiment of the present invention.

FIG. 11 shows a second modified implementation of the adjustable postoperative safety tube according to the above embodiment of the present invention.

FIG. 12 is a partial cross-sectional schematic diagram of the adjustable postoperative safety tube according to the second variant embodiment of the present invention.

FIG. 13 shows a third modified implementation of the adjustable postoperative safety tube according to the above embodiment of the present invention.

FIG. 14 shows a schematic diagram of the application of the adjustable postoperative safety tube according to the third variant embodiment of the present invention.

FIG. 15 shows a fourth modified implementation of the adjustable postoperative safety tube according to the above embodiment of the present invention.

FIG. 16 shows a fifth modified implementation of the adjustable postoperative safety tube according to the above embodiment of the present invention.

FIG. 17 shows a sixth modified implementation of the adjustable postoperative safety tube according to the above embodiment of the present invention, wherein the airbag assembly of the adjustable postoperative safety tube is in a non-inflated state.

FIG. 18 is a perspective schematic diagram of the adjustable postoperative safety tube according to the sixth variant embodiment of the present invention, wherein the inner extension portion of the adjustable postoperative safety tube is in an inflated state.

FIG. 19 is a partial enlarged schematic diagram of the airbag assembly of the adjustable postoperative safety tube according to the sixth variant embodiment of the present invention.

FIG. 20 is a flow chart of a method for using an adjustable postoperative safety tube according to an embodiment of the present invention.

FIG. 21 is a schematic diagram showing the existing need to establish an observation channel between the patient's kidney and the outside world.

FIG. 22 shows a stereoscopic view of a first embodiment of a medical observation channel forming assembly according to the present invention.

Figure 23 shows a partial cross-sectional view along the A-A direction of the first embodiment of the medical observation channel forming component described in the present invention.

24A-24E are schematic diagrams showing the process of the medical observation channel forming component of the present invention establishing an observation channel between the patient's kidney and the outside world.

FIG. 25 is a three-dimensional diagram showing a partial structure of the second embodiment of the medical observation channel forming assembly of the present invention in one state.

FIG. 26 shows a three-dimensional view of a partial structure of the second embodiment of the medical observation channel forming assembly of the present invention in a first state.

Figure 27 shows a partial cross-sectional view of the B-B direction of part of the structure of the second embodiment of the medical observation channel forming component of the present invention in the second state.

Figure 28 shows a partial cross-sectional view of the C-C direction of a partial structure of the second embodiment of the medical observation channel forming component of the present invention in one state.

Detailed ways

Below, the exemplary embodiments according to the present application will be described in detail with reference to the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application, and it should be understood that the present application is not limited to the exemplary embodiments described here.

Application Overview

As described in the background art, unlike the human urethra, the surgical fistula is not a natural passage of the human body, that is, after surgery, the surgical fistula will gradually shrink over time until it heals, while the human urethra will not shrink over time, so that existing drainage tubes (such as urinary catheters) cannot be directly applied to surgical fistulas after surgery. In addition, in order to meet the needs of different groups of people, existing urinary catheters are usually designed to be long enough and relatively smooth, so that the existing urinary catheters are easy to slide inward along the natural passage of the human body and the head thereof touches the inner wall of the organ, causing adverse effects or harm to the patient's body. Therefore, there is a need for an adjustable postoperative safety tube specifically for human fistulas, which can not only provide a safe passage for secondary surgery within a period of time without hindering the wound healing of the surgical fistula, avoiding the reconstruction of the surgical fistula and causing harm to the patient, but also can adjust the length of the surgical fistula insertion to meet the needs of different groups of people.

Specifically, the technical concept of the present application is to use a degradable safety tube to replace the traditional drainage tube while fully considering the self-healing characteristics of the surgical fistula and its difference from the natural channels of the human body, so as to retain the safety channel for a period of time, and assist the wound healing of the surgical fistula through the degradation of the safety tube, so as to avoid the need for a second surgery within a period of time to reconstruct the surgical fistula and bring harm to the patient. At the same time, an adjustable component with an adjustable installation position is used to limit the length of insertion into the surgical fistula, so as to avoid the safety tube sliding inward along the surgical fistula and irritating the inner wall of the organ.

Based on this, the present application provides an adjustable postoperative safety tube for being inserted into a surgical fistula after surgery, wherein the adjustable postoperative safety tube comprises: a safety tube body, wherein the safety tube body is made of a degradable material, and the safety tube body is used to define a safety channel in the surgical fistula; an inner extension portion, wherein the inner extension portion is connected to the front end of the safety tube body, and the in-body opening of the safety channel is located at the head of the inner extension portion; and an adjustable component, wherein the adjustable component comprises a limit piece that is adjustably mounted on the rear end of the safety tube body, and is used to limitably change the length of the safety tube body allowed to be inserted into the surgical fistula by adjusting the installation position of the limit piece.

Based on this, the present application also provides a method for using an adjustable postoperative safety tube, which includes the following steps: inserting the inner extension portion and the safety tube body of the adjustable postoperative safety tube into the surgical fistula to define a safety channel in the surgical fistula; installing a limiter of an adjustable component at the rear end of the safety tube body in an adjustable position to limit the change in the length of the safety tube body allowed to be inserted into the surgical fistula; and degrading the safety tube body so that the outer diameter of the safety tube body decreases as the surgical fistula heals and shrinks.

For some animals with lesions in their internal organs, it is necessary to create at least one surgical channel AO (see Figure 1) on the animal that is connected to the outside world, so as to facilitate the subsequent treatment of the diseased internal organs. Especially in the field of human medicine, in existing surgical operations, after the surgical channel AO is created, a wound connected to the surgical channel AO is usually formed on the patient. In order to prevent the surgical channel AO from being infected, medical staff will plug gauze in the wound to stop bleeding.

As for the recovery of the patient's internal organs, it usually takes a predetermined recovery period after the operation to know the effect of the operation. The recovery period of some internal organ surgeries is as long as several months. During this period, because the patient has the ability to heal the wound by itself, the previously opened channel may have been partially closed before the recovery period is over. If the patient finds that the recovery of the internal organs is not ideal during this period and needs another operation, the closed surgical channel AO needs to be opened again. This will cause the patient the pain of a second operation.

In addition, since the gauze plugged in the wound has no auxiliary fixation, once the patient makes a certain range of movement, the gauze plugged in the wound is easy to fall off. In this way, the tissue corresponding to the surgical channel AO on the patient may be infected, which will bring certain potential threats to the patient's health.

In addition, after the surgical channel AO is created, the tissue forming the surgical channel AO on the patient's body will bleed. If the bleeding is not stopped in time, the tissue forming the surgical channel AO on the patient's body may deteriorate, thereby aggravating the injury.

Illustrative Embodiments

With reference to Figures 1 to 7 of the accompanying drawings of the specification of the present invention, an embodiment of the present invention provides an adjustable postoperative safety tube 1 for inserting into a surgical fistula 2 after surgery, wherein the surgical fistula 2 can be implemented, but not limited to, as a surgical channel constructed during operations such as percutaneous nephrolithotomy or percutaneous hepatobiliary endoscopy, so that medical instruments such as endoscopes can be inserted into the corresponding organs through the surgical channel for surgery. It is understandable that since the surgical fistula 2 constructed in these operations is not a natural channel of the human body, after the operation, the surgical fistula 2 will gradually heal and shrink until it disappears. For ease of explanation, this application defines the direction of the adjustable postoperative safety tube 1 entering the body as the front, and the direction outside the body as the back.

Specifically, as shown in Figures 1, 2 and 3, the adjustable postoperative safety tube 1 may include a safety tube body 10, an inner extension 20 and an adjustable component 30. The safety tube body 10 is made of a degradable material, and the safety tube body 10 is used to define a safety channel 100 in the surgical fistula 2 to connect the internal organs and the external space. The inner extension 20 is connected to the front end of the safety tube body 10, and the internal opening 101 of the safety channel 100 is located at the head of the inner extension 20. The adjustable component 30 includes a limiter 31 that is adjustably mounted on the rear end of the safety tube body 10, and is used to restrictively change the length of the surgical fistula 2 allowed to be inserted on the safety tube body 10 by adjusting the installation position of the limiter 31.

It is worth noting that, as shown in Figure 7, since the safety tube body 10 of the adjustable postoperative safety tube 1 is made of degradable material, after the adjustable postoperative safety tube 1 is inserted into the surgical fistula 2, as the surgical fistula 2 gradually heals and shrinks, the safety tube body 10 of the adjustable postoperative safety tube 1 gradually degrades, so that while retaining the safety channel 100, its outer diameter gradually decreases, so that the outer diameter size of the safety tube body 10 of the adjustable postoperative safety tube 1 can be synchronously matched with the inner diameter size of the surgical fistula 2, so as to prevent the adjustable postoperative safety tube 1 from hindering the healing progress of the surgical fistula 2.

In addition, as shown in FIG3 , since the limiter 31 of the adjustable component 30 of the adjustable postoperative safety tube 1 can be adjustably installed at the rear end of the safety tube body 10, the length of the safety tube body 10 that is allowed to be inserted into the surgical fistula 2 can not only be limited to prevent the safety tube body 10 from sliding forward indefinitely and completely submerging into the surgical fistula 2, but also the length of the safety tube body 10 that is allowed to be inserted into the surgical fistula 2 can be changed to accommodate patients of different groups. For example, for patients who are fatter or larger in size, the installation position of the limiter 31 in the adjustable postoperative safety tube 1 on the safety tube body 10 is moved backward, so that the length of the safety tube body 10 that is allowed to be inserted into the surgical fistula 2 becomes longer; while for patients who are thinner or smaller in size, the installation position of the limiter 31 in the adjustable postoperative safety tube 1 on the safety tube body 10 is moved forward, so that the length of the safety tube body 10 that is allowed to be inserted into the surgical fistula 2 becomes shorter.

According to the above embodiments of the present application, the degradable material can be, but is not limited to, implemented as a degradable medical polymer material, such as polylactic acid (PLA), PLC copolymer, PGG copolymer, polyglycolic acid (PGA), polycaprolactone (PCL), polydioxanone or polytrimethylene carbonate (PTMC) and the like. It is understandable that when the adjustable postoperative safety tube 1 is inserted into the surgical fistula 2, the blood exuded from the capillaries on the inner wall of the surgical fistula 2 will first contact the outer wall of the safety tube body 10 of the adjustable postoperative safety tube 1, causing the safety tube body 10 of the adjustable postoperative safety tube 1 to gradually degrade from the outside to the inside under the action of the blood, so that the adjustable postoperative safety tube 1 can provide the safety channel 100 for a period of time, while its outer diameter gradually decreases to match the gradually shrinking surgical fistula 2, so as to avoid the adjustable postoperative safety tube 1 hindering the wound healing of the surgical fistula 2.

Preferably, in the process of preparing the safety tube body 10 of the adjustable postoperative safety tube 1 from the degradable material, some hemostatic drugs and/or anti-infective drugs can be additionally added to the degradable material, so that during the degradation process of the safety tube body 10, the added hemostatic drugs and/or anti-inflammatory drugs are slowly released into the surgical fistula 2, so as to achieve hemostatic and/or anti-inflammatory effects, and help the wound healing of the surgical fistula 2. It is understandable that the hemostatic drug can be implemented as, but not limited to, Anloxetine, vitamin C or Rutin, etc.; the anti-infective drug can be implemented as, but not limited to, β-lactamase inhibitors or quinolone drugs, etc.

According to the above-mentioned embodiment of the present application, the limit piece 31 of the adjustable component 30 of the adjustable postoperative safety tube 1 is adjustably installed on the rear end of the safety tube body 10, so that when the safety tube body 10 of the adjustable postoperative safety tube 1 is inserted into the surgical fistula 2, the limit piece 31 of the adjustable component 30 is maintained outside the body to abut against the skin surface, so that the length of the safety tube body 10 allowed to be inserted into the surgical fistula 2 can be controllably changed, which is convenient for preventing the adjustable postoperative safety tube 1 from accidentally sliding forward and causing the inner extension part 20 to stimulate the inner wall of the organ, while also being able to meet the different requirements of patients from different groups for the insertion length of the safety tube body 10.

Exemplarily, as shown in FIG3 and FIG6 , the limiter 31 of the adjustable component 30 of the adjustable postoperative safety tube 1 includes a sleeve portion 311 that is adjustably sleeved on the safety tube body 10 and a stopper portion 312 that extends outwardly and laterally from the sleeve portion 311, wherein when the safety tube body 10 of the adjustable postoperative safety tube 1 is inserted into the surgical fistula 2, the sleeve portion 311 of the limiter 31 is sleeved on the rear end of the safety tube body 10, so that the stopper portion 312 of the limiter 31 abuts against the skin outside the body to prevent the rear end of the safety tube body 10 of the adjustable postoperative safety tube 1 from sliding forward into the surgical fistula 2. In fact, when the sleeve portion 311 of the limiter 31 is sleeved on different positions of the safety tube body 10, the length of the safety tube body 10 that is allowed to be inserted into the surgical fistula 2 is different, so as to meet the needs of patients of different groups or meet the needs of different organs. It is understandable that the stopper 312 of the stopper 31 can be implemented as a stopper sheet made of a flexible material so as to fully fit the skin outside the body. Of course, the stopper 312 of the stopper 31 can also be made of a rigid material, but its surface shape needs to be ergonomically designed so as to still fully fit the skin outside the body.

In the above example of the present application, as shown in FIG3 , the sleeve portion 311 of the stopper 31 is preferably interference fit with the safety tube body 10, that is, the inner diameter of the sleeve portion 311 of the stopper 31 is equal to or slightly smaller than the outer diameter of the safety tube body 10, so that when the sleeve portion 311 is sleeved on the safety tube body 10, the sleeve portion 311 and the safety tube body 10 are squeezed to increase the friction between the two, so that the stopper 31 will not slide on the safety tube body 10 unintentionally or accidentally, so as to achieve a better limiting effect (i.e., it can relatively stably limit the length of the safety tube body 10 that is allowed to be inserted into the surgical fistula 2). At the same time, under the action of external force, the sleeve portion 311 can slide forward or backward along the safety tube body 10, so as to adjust the sleeve position of the sleeve portion 311 on the safety tube body 10 according to the needs, thereby changing the length of the safety tube body 10 that is allowed to be inserted into the surgical fistula 2, so as to meet the needs of different people or surgical fistulas of different lengths. It can be understood that when the inner contour shape of the sleeve portion 311 is different from the outer contour shape of the safety tube body 10, an interference fit between the sleeve portion 311 of the limiter 31 and the safety tube body 10 can also be achieved; for example, when the outer contour shape of the safety tube body 10 is a perfect circle, the inner contour shape of the sleeve portion 311 of the limiter 31 is an ellipse, and the inner minor axis length of the sleeve portion 311 is slightly smaller than the outer diameter of the safety tube body 10.

Preferably, as shown in FIG6 and FIG7, the adjustable component 30 of the adjustable postoperative safety tube 1 further includes an adhesive layer 32 disposed on the front side of the stopper 312 of the limiter 31, so as to adhesively attach the stopper 312 of the limiter 31 to the external skin to prevent the adjustable postoperative safety tube 1 from loosening or moving. It is understandable that the adhesive layer 32 of the adjustable component 1 can be implemented as, but not limited to, double-sided tape or formed by applying a sticky material such as glue to the inner side of the limiter. In addition, a coating can be provided on the outer side of the adhesive layer 32, which can protect the adhesive layer 32 from being contaminated or damaged before use, and when in use, the coating can be torn off, so that the stopper 312 of the limiter 31 can be bonded to the external skin through the adhesive layer 32 for fixation.

More preferably, the adjustable component 30 of the adjustable postoperative safety tube 1 further includes a blocking piece 33, wherein the blocking piece 33 is suitable for blocking the extracorporeal opening 102 of the safety channel 100 of the adjustable postoperative safety tube 1, so as to block the extracorporeal opening 102 of the safety channel 100 without drainage or pulling out the guide member 3, thereby preventing extracorporeal air or dust from entering the internal organs through the safety channel 100.

Optionally, as shown in FIG3 , the blocking member 33 is flexibly connected to the stopper 312 of the stopper 31, so that after the blocking member 33 is removed from the external opening 102 of the safety passage 100, the blocking member 33 is still connected to the stopper 312 of the stopper 31, so as to avoid the blocking member 33 from being lost or inconvenient to carry. It is understandable that the blocking member 33 of the present application can be implemented as a pipe plug that is compatible with the external opening 102 of the safety passage 100, but is not limited to it, and the blocking member 33 can be connected to the stopper 312 of the stopper 31 through a connecting member such as a belt or a rope. Of course, the two ends of the connecting member can be integrally connected to the blocking member 33 and the stopper 312 of the stopper 31, that is, the stopper 312 of the blocking member 33 is integrally formed with the stopper 31.

According to the above-mentioned embodiments of the present application, as shown in Figures 4 to 7, taking percutaneous nephrolithotomy as an example: first, a fistula 2 connecting the kidney and the outside is constructed through surgery to insert a guide 3; then, a sheath 4 is inserted along the guide 3 to form a surgical channel through the sheath 4, so that medical devices such as an endoscope can be inserted through the channel formed by the sheath 4 to perform observation or treatment surgery; then, after the operation is completed, the adjustable postoperative safety tube 1 is sent in along the guide 3; finally, the sheath 4 and the guide 3 are removed, and the adhesive layer 32 of the adjustable component 30 is bonded to the skin outside the body, so that the adjustable postoperative safety tube 1 is stably retained in the surgical fistula 2 to pass through the adjustable postoperative safety tube 1. The whole tube 1 maintains the safety channel 100 for a period of time in the surgical fistula 2. In this way, if a secondary operation is required later, the surgical channel can be reestablished by simply inserting the guide 3 along the safety channel 100 of the adjustable postoperative safety tube 1.

It is worth noting that the guide member 3 of the present application can be, but is not limited to, implemented as a guide wire or a predetermined guide member specially made to cooperate with the adjustable postoperative safety tube 1. In other words, in actual manufacturing, the shape and size of the guide member 3 can be designed according to the size and shape of the adjustable postoperative safety tube 1. If the requirements are consistent with the existing guide wire, the existing guide wire can be used for guidance. If they are inconsistent, it is necessary to manufacture a guide member 3 that cooperates with the adjustable postoperative safety tube 1 separately.

It is understandable that, since the adjustable postoperative safety tube 1 is inserted into the sheath 4 along the guide 3, the outer diameter of the safety tube body 10 of the adjustable postoperative safety tube 1 must be smaller than the size of the channel in the sheath, and thus will inevitably be smaller than the initial inner diameter of the surgical fistula 2. Therefore, after the sheath 4 is removed, there will be a gap between the outer surface of the safety tube body 10 of the adjustable postoperative safety tube 1 and the inner wall of the surgical fistula 2, which is not only not conducive to the hemostasis of the wound of the surgical fistula 2, but also easy for external bacteria to enter the surgical fistula 2 and cause infection risks. In order to solve this problem, the safety tube body 10 of the adjustable postoperative safety tube 1 of the present application can further have the characteristic of swelling when encountering liquid, so that after the sheath 4 is removed, the blood or other liquid in the surgical fistula 2 will contact the safety tube body 10, so that the safety tube body 10 expands to closely contact the inner wall of the surgical fistula 2, so as to block the capillaries that ooze blood, thereby playing the role of squeezing hemostasis. In addition, since the safety tube body 10 expands when in contact with liquid and closely contacts the inner wall surface of the surgical fistula 2, the hemostatic drug carried by the safety tube body 10 can directly contact the wound of the surgical fistula 2, thereby achieving a better hemostatic effect.

Specifically, as shown in FIG6 , the degradable material used to prepare the safety tube body 10 is also a water-swellable material, so that the safety tube body 10 will swell when it contacts blood or other liquids in the surgical fistula 2, so that it can achieve the effect of squeezing hemostasis while slowly degrading. Of course, in other examples of the present application, during the preparation of the safety tube body 10 of the adjustable postoperative safety tube 1 from the degradable material, a water-swellable material can be further added to the degradable material, so that the safety tube body 10 of the adjustable postoperative safety tube 1 contacts blood or other liquids in the surgical fistula 2 and swells, so as to closely contact the inner wall of the surgical fistula 2. It is understandable that the water-swellable material can be, but is not limited to, implemented as a material such as a water-soluble polyurethane or a highly absorbent resin.

According to the above embodiment of the present application, as shown in FIG. 2 , the inner extension portion 20 of the adjustable postoperative safety tube 1 is preferably integrally connected to the front end of the safety tube body 10 , that is, the inner extension portion 20 extends forward integrally from the front end of the safety tube body 10 .

More preferably, the inner extension 20 and the safety tube body 10 are made of a degradable material in one piece. For example but not limited to, when manufacturing the adjustable postoperative safety tube 1, the adjustable postoperative safety tube 1 can be formed once or multiple times by means of a mold or blow molding, injection molding, etc., and the safety tube body 10 and the inner extension 20 are formed once or multiple times. Of course, in other examples of the present invention, the safety tube body 10 and the inner extension 20 can also be detachably connected, which will not be described in detail in this application.

It is worth noting that after the adjustable postoperative safety tube 1 is inserted into the surgical fistula 2 for a period of time, the fluid flowing out of the safety channel 100 of the adjustable postoperative safety tube 1 is observed in vitro (such as whether it contains blood or pus, etc.) to determine whether a second operation is needed. If the operation needs to be repeated, the guide 3 is first inserted along the safety channel 100, and then the safety tube that has not been completely degraded is pulled out, and the sheath 4 is placed under the guidance of the guide 3 to construct the surgical channel; or the sheath 4 is directly placed based on the safety tube that has not been completely degraded to construct the surgical channel. If the operation does not need to be repeated, as time goes by, the internal part of the adjustable postoperative safety tube 1 (including the inner extension 20 and the part of the safety tube body 10 located in the body) will automatically degrade, and the external part of the adjustable postoperative safety tube 1 (including the inner and outer parts 20 and the part of the safety tube body 10 located in the body) will automatically fall off or can be cut off, so that the surgical fistula 2 will be completely healed, as shown in Figure 7. Of course, in other examples of the present application, if there is no need to re-perform the operation, the adjustable postoperative safety tube 1 that has not been completely degraded can be directly pulled out to completely eliminate the safety channel 100 .

In other words, in addition to providing the safety channel 100, the adjustable postoperative safety tube 1 can also provide a drainage channel to allow the fluid in the internal organs to flow out to the outside of the body through the channel of the adjustable postoperative safety tube 1, so that doctors and other professionals can judge the postoperative recovery situation based on the situation of the outflowing fluid, and then determine whether a second operation is needed.

In one example of the present application, the safety channel 100 and the drainage channel in the adjustable postoperative safety tube are preferably implemented as the same channel, that is, there is only one inner channel in the adjustable postoperative safety tube 1, so that the safety channel 100 can be inserted into the guide 3 to reconstruct the surgical channel during a secondary operation, and can also be used as the drainage channel to drain the fluid in the internal organs to the outside of the body. Of course, in other examples of the present application, the safety channel 100 and the drainage channel in the adjustable postoperative safety tube 1 can also be implemented as different channels, that is, the adjustable postoperative safety tube 1 can have two or more inner channels.

Exemplarily, as shown in Fig. 2 and Fig. 5, when the adjustable postoperative safety tube 1 has only one inner channel, namely, the safety channel 100, the guide member 3 is suitable for being inserted into the body opening 101 of the safety channel 100 of the adjustable postoperative safety tube 1, so as to insert the adjustable postoperative safety tube 1 into the surgical fistula 2 under the guidance of the guide member 3. It can be understood that when the guide member 3 is withdrawn, the body opening 101 of the safety channel 100 of the adjustable postoperative safety tube 1 is unblocked, and at this time, the fluid in the body organ can flow into the safety channel 100 via the body opening 101, and then flow out to the outside of the body through the safety channel 100.

It is worth noting that although the internal opening 101 of the safety channel 100 can allow fluid in the internal organs to flow through, in some operations, wounds need to be formed in the internal organs, so that the internal organs will inevitably bleed to varying degrees after the operation, which may cause blood clots or other particles (such as gravel, etc.) in the fluid drained through the safety channel 100, which may easily block the internal opening 101 and cause the problem of drainage failure. Of course, this problem can be solved to a certain extent by increasing the size of the internal opening 101, but due to the small size of the head of the inner extension part 20, it is difficult to increase the size of the internal opening 101. Therefore, in order to solve this problem, as shown in FIGS. 1 to 3 , the inner extension portion 20 of the adjustable postoperative safety tube 1 may be further provided with at least one drainage groove 21, wherein the notch of the drainage groove 21 is located on the peripheral side wall of the inner extension portion 20, and the notch of the drainage groove 21 is connected to the safety channel 100, so as to allow the fluid in the internal organs to be drained from the peripheral side wall of the inner extension portion 20 to the safety channel 100 through the drainage groove 21, and then drained out of the body through the safety channel 100. It can be understood that, since the notch of the drainage groove 21 is provided on the peripheral side wall of the inner extension portion 20, and the size of the peripheral side wall of the inner extension portion 20 is much larger than the size of the head of the inner extension portion 20, the size of the notch of the drainage groove 21 can be designed to be large enough to avoid being blocked by blood clots or other particles in the fluid.

Preferably, the notch of the drainage groove 21 extends longitudinally from the head of the inner extension portion 20 to a predetermined position so as to extend the length of the notch of the drainage groove 21 as much as possible to prevent the drainage groove 21 from being blocked.

More preferably, as shown in FIG. 2 , the inner extension 20 of the adjustable postoperative safety tube 1 preferably has a plurality of drainage grooves 21, and the plurality of drainage grooves 21 are evenly distributed on the peripheral sidewall of the inner extension 20, that is, the plurality of drainage grooves 21 evenly surround the safety channel 100, so as to divert the fluid in the internal organs into the safety channel 100, and prevent the accumulation of particles such as blood loss and blockage. At the same time, the plurality of drainage grooves 21 also help to drain the fluid at all positions in the internal organs into the safety channel 100, which helps to speed up the drainage speed and efficiency and avoid the occurrence of drainage dead corners. It can be understood that the structure of the drainage groove 21 of the present application may have other features. For example, the drainage groove 21 may be formed by the cooperation of a tube body and a guide vane, a protective vane may be further provided at the outer end of the guide vane, and a through hole may be provided on the guide vane to connect two adjacent drainage grooves 21, etc. These specific structures are recorded in the applied PCT patent "Anti-blocking Catheter for Surgical Use", and the present application will not repeat them here.

It is worth noting that in the above embodiments of the present application, the inner extension part 20 extends straight forward from the front end of the safety tube body 10 to be in an interpenetrating state, so as to facilitate the insertion of the inner extension part 20 of the adjustable postoperative safety tube 1 into the internal organ through the surgical fistula 2. However, although the limiter 31 of the adjustable component 30 of the adjustable postoperative safety tube 1 can limit the length of the safety tube body 10 that is allowed to extend into the surgical fistula 2 to prevent the safety tube body 10 from sliding forward without restriction along the surgical fistula 2, and the adhesive layer 32 of the adjustable component 30 is bonded to the external skin to prevent the safety tube body 10 from sliding backward along the surgical fistula 2 to a certain extent, once the adhesive layer 32 is not bonded firmly enough or is separated from the external skin under the action of external force, the adjustable postoperative safety tube 1 still has the risk of falling out of the surgical fistula 2. Therefore, in order to solve this problem, Figures 8 to 10 show a first modified embodiment of the adjustable postoperative safety tube 1 according to the above-mentioned embodiment of the present application, wherein the inner extension portion 20 has an insertion state 201 and a fixed state 202, wherein when the inner extension portion 20 is in the insertion state 201, the inner extension portion 20 extends straight forward from the front end of the safety tube body 10, and when the inner extension portion 20 is in the fixed state 202, the inner extension portion 20 extends from the front end of the safety tube body 10 in a curved manner.

Specifically, as shown in FIGS. 8 and 9 , the inner extension portion 20 of the adjustable postoperative safety tube 1 is bent in a natural state so as to be in the fixed state 202; but it is suitable for being straightened under the guidance of the guide member 3 so as to be in the insertion state 201. That is to say, in the process of using the adjustable postoperative safety tube 1, if it is necessary to insert the adjustable postoperative safety tube 1 into the corresponding organ through the surgical fistula 2, or if it is necessary to remove the adjustable postoperative safety tube 1 from the surgical fistula 2, the adjustable postoperative safety tube 1 is roughly straightened under the guidance of the guide member 3, that is, the inner extension portion 20 is in the insertion state 201, so that the adjustable postoperative safety tube 1 can be smoothly inserted into the surgical fistula 2; and when the adjustable postoperative safety tube 1 is inserted into the corresponding organ through the surgical fistula 2, After the organ is removed, the guide 3 is pulled out, and the inner extension 20 of the adjustable postoperative safety tube 1 will naturally recover and become curved to be in the fixed state. At this time, since the inner extension 20 of the adjustable postoperative safety tube 1 is curved, it does not match the linear channel of the surgical fistula 2, so the adjustable postoperative safety tube 1 will not be able to escape from the surgical fistula 2, which is convenient for fixing the adjustable postoperative safety tube 1 in the surgical fistula 2. It can be understood that the bending of the inner extension 20 of the adjustable postoperative safety tube 1 is an elastic change, which is related to the organ morphology requirements during use.

It is worth noting that, due to the basic structure of traditional urinary catheters, the insertion head is generally in a straight line, so the length of the urinary catheter inserted into the bladder will affect the user's feeling. If it is too long, it will cause adverse stimulation reactions such as urgency to urinate to the patient. If it is too short or too close to the outside, it cannot achieve a good diversion effect, so that this type of urinary catheter requires a higher level of operation. When the inner extension portion 20 of the adjustable postoperative safety tube 1 according to the present invention is in the fixed state 202, that is, when it is located in an organ in the body, the inner extension portion 20 of the adjustable postoperative safety tube 1 is naturally bent, which can not only fix the safety tube, but also reduce the stimulation of the inner extension portion 20 on the organ, thereby relatively reducing the requirements for the operation level of medical staff in placing the safety tube.

Exemplarily, as shown in FIG10 , taking percutaneous nephroscopic surgery as an example: first, a fistula 2 connecting the kidney and the outside is constructed through surgery to insert a guide wire; then, a sheath 4 is inserted along the guide wire to form a surgical channel through the sheath 4, so that a medical device such as an endoscope can be inserted through the channel formed by the sheath 4 to perform observation or treatment surgery; then, after the surgery is completed, the adjustable postoperative safety tube 1 is inserted along the guide wire (at this time, the inner extension 20 of the adjustable postoperative safety tube 1 is in the interlaced state 201 under the action of the guide wire); finally, the sheath 4 and the guide wire are removed, and the inner extension 20 of the adjustable postoperative safety tube 1 will be in the fixed state 202, so that the adjustable postoperative safety tube 1 is stably placed in the surgical fistula 2, so that the adjustable postoperative safety tube 1 maintains the safety channel 100 in the surgical fistula 2 for a period of time. In this way, if a secondary surgery is required later, it is only necessary to insert a guide wire along the safety channel 100 of the adjustable postoperative safety tube 1 to re-establish the surgical channel.

Preferably, the inner extension part 20 of the adjustable postoperative safety tube 1 is integrally extended longitudinally from the front end of the safety tube body 10, and when the adjustable postoperative safety tube 1 has only one inner channel, namely the safety channel 100, the in-body opening 101 of the safety channel 100 of the adjustable postoperative safety tube 1 is preferably located at the head of the inner extension part 20, so as to ensure that after the guide 3 is inserted into the adjustable postoperative safety tube 1, the inner extension part 20 of the adjustable postoperative safety tube 1 is straightened to be in the insertion state 201. It can be understood that, after the guide is withdrawn, the inner extension part 20 of the adjustable postoperative safety tube 1 is bent to be in the fixed state 202, at which time the fluid in the internal organs can flow into the safety channel 100 via the in-body opening 101, and then flow out to the outside of the body through the safety channel 100.

More preferably, the notch of the drainage groove 21 extends longitudinally from the head of the inner extension 20 to a predetermined position, so that when the inner extension 20 is in the fixed state 202, the notch of the drainage groove 21 is bent, that is, the drainage groove 21 forms a drainage bend instead of a straight drainage. It can be understood that this curved drainage method can reduce the probability of direct accumulation of particles such as blood clots to a certain extent because it does not form a large area of a straight plane or a bearing surface.

Most preferably, as shown in FIG. 8 , the extension lengths of the plurality of drainage grooves 21 are different from each other, and the length of the drainage groove 21 located on the inner side of the bend of the inner extension portion 20 is shorter than the length of the drainage groove 21 located on the outer side of the bend of the inner extension portion 20 .

It is worth noting that Figures 11 and 12 show a second variant implementation of the adjustable postoperative safety tube 1 according to the above embodiment of the present application. Specifically, compared with the above first variant implementation, the difference of the adjustable postoperative safety tube 1 according to the second variant implementation of the present application is that the limiter 31 of the adjustable component 30 may further include a fastener 313, wherein the fastener 313 is used to securely fix the sleeve portion 311 of the limiter 31 to a predetermined position of the safety tube body 10 to prevent the sleeve portion 311 from accidentally sliding on the safety tube body 10, so as to stably limit the length of the safety tube body 10 that allows the surgical fistula 2 to be inserted. It can be understood that in this embodiment of the present application, the sleeve portion 311 and the stop portion 312 of the limit member 31 can be made of different materials. For example, the sleeve portion 311 is made of a hard material, and the stop portion 312 is made of a soft material. At this time, the sleeve portion 311 and the stop portion 312 can be connected together by means of embedding or gluing.

Optionally, as shown in FIG11 , the stopper portion 312 of the stopper 31 extends outwardly from the front end of the sleeve portion 311, and the fastener 313 is screwed to the rear end of the sleeve portion 311, so that the fastener 313 increases the squeezing force of the sleeve portion 311 on the safety tube body 10, thereby stably fixing the stopper 31 to a predetermined position on the safety tube body 10. It is understandable that when the position of the stopper 31 on the safety tube body 10 needs to be adjusted, it is only necessary to remove the fastener 313 from the sleeve portion 311. The squeezing force applied to the sleeve portion 311 is removed, so that the sleeve portion 311 of the limiting member 31 can slide on the safety tube body 10 under the action of external force to change the length of the safety tube body 10 that allows the surgical fistula 2 to be inserted.

Specifically, as shown in FIG. 12 , the sleeve portion 311 of the stopper 31 is provided with an external thread, and the fastener 313 is provided with an internal thread matching the external thread, so that when the internal thread of the fastener 313 and the external thread of the sleeve portion 311 are engaged with each other, the fastener 313 will apply an extrusion force to the sleeve portion 311, so that the friction between the sleeve portion 311 and the safety tube body 10 becomes larger, so as to prevent the sleeve portion 311 from sliding relative to the safety tube body 10 under the action of a smaller external force or its own gravity. , thereby stably limiting the length of the safety tube body 10 that is allowed to be inserted into the surgical fistula 2; and when the internal thread of the fastener 313 is not engaged with the external thread of the sleeve portion 311, the extrusion force applied by the fastener 313 to the sleeve portion 311 is removed, so that the friction between the sleeve portion 311 and the safety tube body 10 becomes smaller. At this time, only a small external force is needed to make the sleeve portion 311 slide forward or backward on the safety tube body 10 to change the length of the safety tube body 10 that is allowed to be inserted into the surgical fistula 2.

Preferably, as shown in FIG. 12 , the stopper 31 further comprises a cushion 314 , wherein the cushion 314 is disposed between the sleeve portion 311 and the safety tube body 10 to increase the friction between the sleeve portion 311 and the safety tube body 10 .

It is worth noting that, since the cushion 314 is provided between the sleeve portion 311 and the safety tube body 10, the inner diameter of the sleeve portion 311 can be larger than the outer diameter of the safety tube body 10, so that while the cushion 314 generates friction between the sleeve portion 311 and the safety tube body 10, it also helps to insert the rear end of the safety tube body 10 into the sleeve portion 311, so as to achieve adjustable socket connection between the sleeve portion 311 and the safety tube body 10.

More preferably, as shown in FIG. 12 , the cushion 314 is embedded in the inner wall of the sleeve portion 311 to prevent the cushion 314 from coming out of the sleeve portion 311 during the sleeve connection of the safety tube body 10 , thereby failing to increase the friction force.

Most preferably, as shown in Figure 12, the fastener 313 includes an annular base 3131, an outer peripheral arm 3132 extending integrally from the outer periphery of the annular base 3131, and an inner peripheral arm 3133 extending integrally from the inner periphery of the annular base 3131, wherein the outer peripheral arm 3132 and the inner peripheral arm 3133 extend longitudinally in the same direction from the annular base 3131 to form a fastening groove 3130 between the outer peripheral arm 3132 and the inner peripheral arm 3133 that is adapted to the rear end of the sleeve portion 311, and the internal thread of the fastener 313 is arranged on the inner side of the outer peripheral arm 3132 to be located in the fastening groove 3130. In this way, when the rear end of the sleeve portion 311 is inserted into the fastening groove 3130 of the fastener 313 for threaded connection, the peripheral arm 3132 of the fastener 313 is covered on the outside of the rear end of the sleeve portion 311 so that the internal thread of the fastener 313 and the external thread of the sleeve portion 311 are engaged with each other; at the same time, the inner peripheral arm 3133 of the fastener 313 extends into the gap between the sleeve portion 311 and the safety tube body 10 to contact the gasket 314, which helps to prevent the gasket 314 from longitudinal deformation, so that the lateral deformation of the gasket 314 is increased, thereby helping to increase the friction between the gasket 314 and the safety tube body 10.

In particular, as shown in Figure 12, the inner circumferential arm 3133 of the fastener 313 has an inclined end surface 31330 facing the safety tube body 10, and when the fastener 313 is screwed together with the sleeve portion 311, the inclined end surface 31330 of the inner circumferential arm 3133 abuts against the side of the gasket 314 to squeeze the gasket 314 toward the safety tube body 10, which helps to further increase the friction between the gasket 314 and the hollow tube 10.

13 and 14 show a third variant implementation of the adjustable postoperative safety tube 1 according to the above embodiment of the present application, wherein the blocking member 33 of the adjustable component 30 is integrally connected to the sleeve portion 311 of the stopper 31, and the blocking member 33 is located in the sleeve portion 311, so that the adjustable component 30 is a cap-shaped structure. In particular, the blocking member 33 is interference-fitted with the safety tube body 10, so that when the sleeve portion 311 of the adjustable component 30 is placed on the rear end of the safety tube body 10, the blocking member 33 blocks the external opening 102 of the safety channel 100.

It is worth noting that in this example of the present application, as shown in FIG14 , the position of the stopper 312 of the limiter 31 on the safety tube 10 is adjusted by controlling the length of the plugging member 33 inserted into the safety tube 10, thereby changing the length of the surgical fistula 2 allowed to be inserted into the safety tube 10 to a certain extent. For example, when the plugging member 33 is inserted into the safety tube 10 for a long time, the position of the stopper 312 of the limiter 31 on the safety tube 10 will move forward, and at this time, the length of the surgical fistula 2 allowed to be inserted into the safety tube 10 will become shorter; and vice versa.

Preferably, the stopper 312 of the stopper 31 is flexibly connected to the safety tube body 10, so that after the blocking member 33 and the stopper 31 are removed from the external opening 102 of the safety passage 100, the stopper 312 of the stopper 31 is still connected to the safety tube body 10. The whole pipe body 10 is connected to prevent the blocking member 33 and the position limiting member 31 from being lost or inconvenient to carry. It is understandable that the stopper 312 of the position limiting member 31 of the present application can be connected to the safety pipe body 10 through a connecting member such as a belt or a rope. Of course, the two ends of the connecting member can be integrally connected to the stopper 312 of the position limiting member 31 and the safety pipe body 10 respectively.

It is worth noting that although the safety tube body 10 of the adjustable postoperative safety tube 1 according to the above-mentioned embodiments and various modified implementations of the present application will gradually degrade from the outside to the inside under the action of blood or other liquids in the surgical fistula 2, different parts of the safety tube body 10 of the adjustable postoperative safety tube 1 may have the problem of uneven degradation speed, that is, some parts of the safety tube body 10 of the adjustable postoperative safety tube 1 degrade quickly, and some parts degrade slowly, resulting in that when the slow degradation part is just half degraded, the fast degradation part has been completely degraded, resulting in the safety channel 100 of the adjustable postoperative safety tube 1 being destroyed, and the safety channel 100 cannot be maintained in a good state. Therefore, in order to solve the above problems, Figure 15 shows a fourth variant implementation of the adjustable postoperative safety tube 1 according to the above embodiment of the present application, wherein the safety tube body 10 of the adjustable postoperative safety tube 1 includes an inner core layer 11 defining the safety channel 100 and an outer tube layer 12 coated on the inner core layer 11, wherein the outer tube layer 12 of the safety tube body 10 is made of the degradable material, and the inner core layer 11 of the safety tube body 10 is made of the non-degradable material.

In this way, when the outer tube layer 12 of the safety tube body 10 is degraded, even if the fluid is drained through the safety channel 100 so that the fluid contacts the inner core layer 11 of the safety tube body 10, the inner core layer 11 of the safety tube body 10 will not be degraded, which not only can well maintain the safety channel 100, but also can ensure that after the outer tube layer 12 is completely degraded, the safety tube body 10 still maintains a smooth outer surface, so that the safety tube body 10 is easy to pull out.

Optionally, the non-degradable material may be, but is not limited to, implemented as a synthetic polymer compound, such as silicone, polytetrafluoroethylene, polyethylene, polypropylene, polyethylene terephthalate (or ester), polyurethane or polyvinyl alcohol, etc.

In particular, the stopper 31 of the adjustable component 30 of the adjustable postoperative safety tube 1 is integrally connected to the inner core layer 11 of the safety tube body 10, so that after the outer tube layer 12 of the safety tube body 10 is degraded, the stopper 31 can still be firmly connected to the safety tube body 10. Of course, the inner extension portion 20 of the adjustable postoperative safety tube 1 can have the same layered structure as the safety tube body 10, and this application will not repeat it in detail.

It is worth noting that in other examples of the present application, the inner core layer 11 in the safety tube body 10 of the adjustable postoperative safety tube 1 is made of a first degradable material, and the outer tube layer 12 of the safety tube body 10 is made of a second degradable material, and the degradation rate of the first degradable material is lower than the degradation rate of the second degradable material. In this way, when the outer tube layer gradually degrades to adapt to the healing contraction of the surgical fistula, the inner core layer slowly degrades to maintain the safety channel for a longer period of time.

FIG16 shows a fifth variant implementation of the adjustable postoperative safety tube 1 according to the above embodiment of the present application, wherein the inner core layer 11 and the outer tube layer 12 in the safety tube body 10 of the adjustable postoperative safety tube 1 can be made of the same degradable material, but the safety tube body 10 can further include an isolation layer 13 arranged between the inner core layer 11 and the outer tube layer 12, wherein the isolation layer 13 is made of a waterproof material to prevent the liquid in the surgical fistula 2 from passing through the isolation layer 13 and contacting the inner core layer 11, to prevent the inner core layer 11 from contacting the liquid in the surgical fistula 2 and being degraded, and to help better maintain the safety passage 100. It can be understood that the waterproof material of the present application is a medical polymer material, such as a PTFE film material or a TPU film material, etc.

17 to 19 show a sixth variant embodiment of the adjustable postoperative safety tube 1 according to the above embodiment of the present application, wherein the adjustable postoperative safety tube 1 may further include an airbag assembly 40, wherein the airbag assembly 40 includes an airbag cavity 41 disposed between the inner extension portion 20 and the safety tube body 10 and an inflation pipe 42 extending along the safety tube body 10 and connected to the airbag cavity 41. In this way, the airbag cavity 41 is inflated through the inflation pipe 42 to form an airbag at a position between the inner extension portion 20 and the safety tube body 10 by inflation, and then the adjustable postoperative safety tube 1 is fixed by the airbag, that is, the airbag assembly 40 is used to fix the adjustable postoperative safety tube 1 at the inner opening position of the surgical fistula 2 (that is, from the body) to prevent the adjustable postoperative safety tube 1 from coming out of the surgical fistula 2.

In one example of the present application, the inflation pipe 42 of the airbag assembly 40 is formed integrally with the inner wall of the safety tube body 10, that is, the tube body forming the inflation pipe 42 is integrally connected to the inner wall of the safety tube body 10. Of course, in other examples of the present invention, the inflation pipe 42 may also be formed by an independent pipe and accommodated in the safety channel 100.

Exemplarily, as shown in FIG. 19 , the airbag assembly 40 has an inflated state 401 and an uninflated state 402, wherein in the inflated state 401, the airbag cavity 41 of the airbag assembly 40 expands so that the surface of the airbag cavity 41 protrudes spherically from the and in the uninflated state 402, the airbag cavity 41 of the airbag assembly 40 shrinks, and its surface is consistent with the surface of the safety tube body 10. That is, in the inflated state 401, the airbag cavity 41 of the airbag assembly 40 forms an airbag and protrudes from the surface of the safety tube body 10.

In this way, when the adjustable postoperative safety tube 1 is used, after the airbag cavity 41 passes through the surgical fistula 2 and enters the predetermined position of the internal organ, an inflation device is used to inflate the airbag cavity 41 through the inflation pipe 42 so that the airbag cavity 41 expands and is fixed in the body, and the inflated airbag can be used to compress and stop bleeding.

Preferably, as shown in Figures 17 and 18, the airbag assembly 40 of the adjustable postoperative safety tube 1 further includes a one-way valve 43, wherein the one-way valve 43 is sealed and arranged in the inflation pipe 42. That is, the airbag cavity 41 can be inflated by the inflation device, and when the airbag cavity 41 is inflated, the one-way valve 43 unidirectionally closes the inflation pipe 42, so that the airbag cavity 41 is maintained in the expanded inflation state 401.

More preferably, the airbag cavity 41 surrounds the outside of the safety channel 100 to form a substantially spherical airbag, or in other words, a ring-shaped supporting and fixing airbag is formed around the safety channel 100. In this way, in the inflated state, the safety channel 100 can still communicate with the inner extension portion 20 and the safety tube body 10 to serve as a drainage channel, so that the fluid in the internal organs can be drained to the outside of the body through the safety channel 100.

It is worth mentioning that according to an embodiment of the present application, as shown in FIG. 20 , the present application further provides a method for using an adjustable postoperative safety tube, which may include the steps of:

S100: inserting an adjustable postoperative safety tube into the surgical fistula, so that the inner extension of the adjustable postoperative safety tube is located in the internal organ;

S200: adjusting the installation position of the adjustable component of the adjustable postoperative safety tube on the safety tube body of the adjustable postoperative safety tube to restrictively change the length of the safety tube body that is allowed to be inserted into the surgical fistula; and

S300: Degrading the safety tube body so that the outer diameter of the safety tube body decreases as the surgical fistula tract heals and shrinks.

It is worth noting that, as shown in FIG. 20 , the method for using the adjustable postoperative safety tube may further include the following steps before step S300:

S400: Expanding the safety tube body so that the outer diameter of the safety tube body becomes larger to match the initial inner diameter of the surgical fistula.

With reference to FIGS. 21 to 28 , a medical observation channel forming component 8100 according to a preferred embodiment of the present invention will be described in detail below, wherein the medical observation channel forming component 8100 can be at least partially retained on the patient's body to connect the patient's internal organs with the external surgical channel, and maintain at least one channel connecting the patient's internal organs with the external environment when the patient's internal organs are in the recovery period.

Specifically, the medical observation channel forming component 8100 forms an observation channel 8101, wherein when the medical observation channel forming component 8100 can at least partially remain in the surgical channel, the observation channel 8101 connects the patient's internal organs with the outside world, so that medical staff can regularly observe the recovery status of the patient's internal organs through the observation channel 8101.

Furthermore, the medical observation channel forming component 8100 includes a main body 810 having an inner end 8102 and an outer end 8103, wherein the observation channel 8101 is formed between the inner end 8102 and the outer end 8103. The observation channel 8101 forms an inner viewing port 81011 at the inner end 8102 and an outer viewing port 81012 at the outer end 8103.

The main body 810 includes a non-degradable part 811 and a degradable part 812 coated outside the non-degradable part 811. The non-degradable part 811 is made of a material that cannot be absorbed by the organism, such as plastic or metal. The degradable part 812 is made of a material that can be absorbed by the organism, such as sheep intestines, chitosan, etc. The non-degradable part 811 forms the observation channel 8101 between the inner end 8102 and the outer end 8103.

Therefore, after the medical observation channel forming component 8100 is inserted into the surgical channel, it is only necessary to keep the inner end 8102 in the patient's operated internal organs and connect the outer end 8103 to the outside world. Medical staff can then regularly perform endoscopy on the patient's operated internal organs through the observation channel 8101 to understand the recovery status of the patient's operated internal organs.

In at least one example of the present invention, the medical observation channel forming component 8100 is retained in the surgical channel to perform endoscopy on the patient's operated kidney. However, this is not a limitation on the use of the medical observation channel forming component of the present invention. In other words, the medical observation channel forming component 8100 can also perform endoscopy on the patient's operated spleen, liver, bladder, lungs, etc.

It is understandable that, since the main body 810 of the medical observation channel forming component 8100 directly connects the operated internal organs of the patient to the outside world, tissue fluid from other parts of the patient will not enter the observation channel 8101. The external viewing port 81012 allows blood to flow out, so it will not interfere with the medical staff's judgment on the recovery of the patient's operated internal organs.

It is worth mentioning that the part of the main body 810 that directly contacts the patient is the degradable part 812, not the non-degradable part 811. Therefore, even if the main body 810 remains in the surgical channel for a long time, the observation channel 8101 formed by the non-degradable part 811 will not be blocked due to the patient's self-healing. It is particularly important to point out that when the patient's visceral surgery is completed and the patient is in the recovery period, the degradable part 812 can be gradually absorbed with the patient's metabolism, so that the overall radial size of the main body 810 will gradually decrease.

If the patient's operated internal organs recover well after the recovery period, the non-degradable portion 811 of the main body 810 can be directly removed. Since the part of the patient's body where the surgical channel is formed has basically healed at this time, and the radial dimension of the non-degradable portion 811 is small, the patient will hardly feel pain when the non-degradable portion 811 is removed. If the patient's operated internal organs do not recover as expected after the recovery period, the medical staff can continue to perform follow-up treatment through the observation channel 8101 formed by the non-degradable portion 811, thereby avoiding the patient from being injured by a secondary operation.

In addition, the degradable part 812 is made of a material that is absorbable by a living body and can swell by absorbing liquid. Thus, after the degradable part 812 is inserted into the surgical channel, the degradable part 812 can absorb the tissue fluid (such as blood) overflowing from the tissue around the surgical channel formed by the patient during the process of opening the surgical channel, and then swell, and in turn press the tissue around the surgical channel, thereby preventing the tissue around the surgical channel from bleeding continuously, so as to accelerate the recovery of the tissue around the surgical channel.

On the other hand, after the expansion, the cross-sectional size of the degradable portion 812 increases, thereby being able to increase the friction between the main body 810 and the patient. As a result, when the main body 810 is left in the surgical channel of the patient, even if the patient makes a certain degree of movement, it is difficult for the main body 810 to deviate from the corresponding posture, thereby allowing the inner end portion 8102 to form the endoscope port 81011 and always remain on the patient's operated internal organs.

It can be understood that by using the medical observation channel forming component 8100, not only will it not hinder the patient's postoperative recovery, but it can also directly form a smooth observation channel 8101 between the patient's internal organs and the outside world after surgery.

Because the observation channel 8101 can be kept unobstructed, the observation channel 8101 can also be used as a pipeline for guiding the fluid flowing out of the patient's internal organs after surgery. In this way, medical staff can accurately judge the recovery of the patient's internal organs by observing and testing the fluid flowing out of the patient's internal organs after surgery.

Referring to FIGS. 25 to 28 , in one embodiment, at least one radially expandable expansion capsule 813 is provided between the non-degradable portion 811 and the degradable portion 812, and the expansion capsule 813 has a cavity 81301 and an outer opening 81302 formed in communication with the cavity 81301. When a predetermined amount of fluid is filled into the cavity 81301 of the expansion capsule 813 and the outer opening 81302 is sealed, the expansion capsule 813 can expand radially. The expanded expansion capsule 813 will drive the degradable portion 812 disposed outside the expansion capsule 813 to move radially, so that after the medical observation channel forming component 8100 is inserted into the surgical channel, the medical staff can press the degradable portion 812 against the tissue of the patient to form the surgical channel by filling the expansion capsule 813 with fluid, so that the patient's tissue can be effectively prevented from continuous bleeding.

It is worth mentioning that the medical staff can also adjust the pressure in the expansion bag 813 by adjusting the amount and type of fluid filled into the expansion bag 813, thereby adjusting the pressure on the tissue forming the surgical channel on the patient. In this way, the pressure on the tissue forming the surgical channel on the patient can be adjusted according to the bleeding state of the tissue forming the surgical channel on the patient, so as to better stop bleeding while taking care of the patient's physical feelings.

In addition, if the patient recovers well after the recovery period and the main body 810 of the medical observation channel forming component 8100 needs to be removed, the fluid in the expansion bag 813 can be discharged to reduce the overall radial size of the main body 810 to a size smaller than the radial size of the surgical channel after the patient's recovery period. In this way, the main body 810 can be quickly removed from the surgical channel.

It is worth mentioning that the fluid filled in the expansion bag 813 can be gas or liquid, and the present invention is not limited in this aspect.

Preferably, the material forming the outer wall of the expansion capsule 813 can be made of a preset membrane material that allows small molecule drugs to pass through. The degradable portion 812 is disposed on the outer wall forming the expansion capsule 813 .

In this way, the tissue healing of the surgical channel formed on the patient's body can be assisted by filling a predetermined amount of small molecule drugs into the cavity 81301. That is, the small molecule drugs filled into the cavity can penetrate into the degradable part 812 through the expansion capsule 813, and then assist the tissue healing of the surgical channel formed on the patient's body together with the degradable part 812.

In addition, a heat-absorbing liquid may be injected into the cavity 81301, so that the heat of the tissue forming the surgical channel on the patient's body can be absorbed by heat exchange to prevent the tissue forming the surgical channel on the patient's body from swelling.

When using the medical observation channel forming component 8100, the cavity 81301 can be first filled with fluid so that the tissue forming the surgical channel on the patient can receive the maximum pressure and stop bleeding quickly. As the patient continues to recover, the amount of fluid in the cavity 81301 can be reduced in a component manner, so that the radial size of the cavity 81301 is reduced to reduce the pressure on the tissue forming the surgical channel on the patient, so that the self-healing of the patient's wound will not be affected. When the patient's wound is completely healed, the radial size of the entire main body 810 can be made smaller than the radial size of the surgical channel by discharging the fluid in the cavity 81301, so that medical staff can pull the main body 810 away from the surgical channel.

Preferably, at least one support portion 814 is provided between the outer wall of the expansion capsule 813 and the degradable portion 812. The inner side of the support portion 814 is connected to the outer wall of the expansion capsule 813, and the outer side of the support portion 814 is connected to the degradable portion 812. The strength of the support portion 814 is greater than the strength of the degradable portion 812, so that after the expansion capsule 813 is filled with fluid, the support portion 814 and the degradable portion 812 located on the periphery of the expansion capsule 813 can be expanded synchronously, so that the cross-sectional shape of the outer wall of the expansion capsule 813 after expansion is annular. In this way, the non-degradable portion 811 radially expanded along with the expansion capsule 813 can fully contact the tissues forming the surgical channel on the patient's body, thereby allowing the tissues forming the surgical channel on the patient's body to be fully pressed to stop bleeding. In other words, the support portion 814 can guide the time and direction of the expansion of the expansion sac 813 to increase the contact area between the tissue forming the surgical channel on the patient and the degradable portion 812, thereby allowing the tissue forming the surgical channel on the patient to stop bleeding quickly.

Preferably, a bendable section 815 is formed on the main body 810 between the inner end 8102 and a predetermined position away from the inner end 8102. The bendable section 815 is configured to be bend in a natural state, and the inner end 8102 of the main body 8102 is rolled inward. In this way, when the main body 810 is retained in the patient's internal organs and the patient performs a certain range of movement, the bent bendable section 815 can reduce the foreign body sensation brought to the patient, thereby alleviating the patient's foreign body reaction.

In addition, the curved bendable section 815 can cooperate with the patient's postoperative internal organs, thereby preventing the entire main body 810 from slipping out of the surgical channel and deviating from the preset posture.

An anti-blocking groove 81501 is formed on the main body 810 between the inner end 8102 and a predetermined position away from the inner end 8102. The anti-blocking groove 81501 is arranged to be connected to the observation channel 8101, so that when the endoscope port 81011 of the inner end 8102 is blocked, medical staff can also observe the surgical viscera of the patient through the anti-blocking groove 81501. In other words, when the observation channel 8101 formed by the endoscope port 81011 and the external viewing port 81012 is blocked, a channel for medical staff to observe can still be formed between the notch of the anti-blocking groove 81501 and the external viewing port 81012 arranged between the outer end 8103. In this way, it can be ensured that there is always a channel for medical staff to observe the postoperative viscera of the patient. Preferably, the anti-blocking groove 81501 is arranged in the bendable section 815.

Furthermore, at least one expandable stopper 816 is formed on the circumferential side of the main body 810 at a predetermined distance from the inner end 8102. The stopper 816 forms a fluid cavity 81601, wherein the fluid cavity 81601 is configured to expand radially after being filled with a predetermined amount of fluid. The radial dimension of the expanded stopper 816 will gradually increase until it is larger than the radial dimension of other parts of the main body 810, and as the fluid in the fluid cavity 81601 is discharged, the radial dimension of the stopper 816 will gradually decrease until it is no larger than the radial dimension of other parts of the main body 810.

After the main body 810 is inserted into the surgical access, the stop portion 816 remains in the patient's postoperative internal organs, so that when a predetermined amount of fluid is subsequently filled into the stop portion 816 and the radial dimension of the stop portion 816 is larger than the radial dimension of other parts of the main body 810 and the radial dimension of the surgical channel, the main body 810 will be difficult to slip out of the patient's postoperative internal organs. In other words, the stop portion 816 can effectively prevent the main body 810 from deviating from a predetermined position, thereby enabling the main body 810 to not only establish a smooth observation channel 8101 between the patient's postoperative internal organs and the outside world, but also enable the inner end portion 8102 of the established observation channel 8101 to always remain in the patient's postoperative internal organs.

This ensures that during the patient's postoperative recovery period, the internal organs that the medical staff see through the external end portion 8103 are always the patient's operated internal organs. This prevents the medical staff from misdiagnosing and causing irreparable medical accidents.

In one embodiment, the fluid chamber 81601 of the deflection-stopping portion 816 is arranged to communicate with the cavity 81301 formed by the expansion bladder 813. In this way, the expansion bladder 813 and the cavity 81301 can share the outer opening 81302.

The direction in which at least a portion of the expansion bladder 813 extends may not be colinear with the direction in which the main body 810 extends, but may be independently extended from the main body 810. The portion 810 is separated into a channel so that the external opening 81302 is not coaxial with the external viewing port 81012.

Referring to Figure 22, further, the medical observation channel forming component 8100 also includes at least one sealing unit 820, wherein the sealing unit 820 is removably sealed to the external viewing port 81012 of the outer end portion 8103, so that when the medical staff does not need to observe the patient's postoperative internal organs through endoscopy, the external viewing port 81012 can be sealed by the sealing unit 820.

Preferably, the sealing unit 820 is fixedly connected to the main body 810 to prevent the sealing unit 820 from being lost and difficult to find. It is understandable that the sealing unit 820 can be fixedly connected to the main body 810 by integral injection molding or by snap-fitting, and the present invention is not limited in this respect.

More preferably, the cavity 81301 formed by the expansion bladder 813 is coaxial with the observation channel 8101. When the sealing unit 820 seals the external viewing port 81012, it can seal the cavity 81301 at the same time.

In one embodiment, a cover body may be separately provided to cover the outer opening 81302 connected to the cavity 81301, so as to prevent the fluid filled in the cavity 81301 from overflowing. In particular, when the cavity 81301 formed by the expansion bladder 813 is not coaxial with the observation channel 8101, the cover body for covering the outer opening 81302 and the sealing unit 820 for covering the external viewing port 81012 may be separately provided.

In order to enable those skilled in the art to understand the preferred embodiments of the present invention, at least one embodiment of the present invention is described by taking as an example that the cavity 81301 and the observation channel 8101 are coaxially arranged, and the external opening 81302 and the external viewing port 81012 are simultaneously covered by the sealing unit 820.

Preferably, the main body 810 is provided with a covering portion 817 extending radially at the outer end 8103. After the patient inserts the main body 810 into the surgical channel, the covering portion 817 can be attached to the wound of the surgical channel of the patient to prevent the main body 810 from excessively deflecting when the patient moves.

Furthermore, the medical observation channel forming assembly 8100 further includes a protective member 830, wherein the protective member 830 is detachably covered on the outer wall of the main body 810. The protective member 830 is made of a non-degradable material.

It can be understood that when the main body 810 needs to be inserted into the surgical channel, the main body 810 covered with the protective member 830 can be first inserted into the surgical channel. Subsequently, by removing the protective member 830, the tissue at the surgical channel on the patient's body can be brought into contact with the degradable portion 812 of the main body 810.

It is worth mentioning that the protective member 830 can prevent the main body 810 from being contaminated in the external environment before being inserted into the surgical channel. On the other hand, during the process of the main body 810 connected to the protective member 830 and inserted into the surgical channel, the protective member 830 can prevent the degradable part 812 of the main body 810 from directly contacting the tissue at the surgical channel of the patient at the beginning, so as to prevent the non-degradable part 811 from being absorbed by the patient's tissue and deformed before the surgery is completely completed.

Preferably, two pre-tear lines are provided on the side wall between the two ends of the protective member 830. The protective member 830 is sleeved on the main body 810 so as to be slidable along the main body 810. In this way, after the protective member 830 is inserted into the surgical channel together with the main body 810, the medical staff can tear the protective member 830 while pulling the protective member 830 outward. By removing the protective member 830 in this way, on the one hand, it can be prevented that the sealing unit 820 covering the external viewing port 81012 interferes with the removal of the protective member 830 in the direction in which the protective member 830 slides away. On the other hand, since the medical staff applies force in the radial direction when pulling out the protective member 830, it can be prevented that the medical staff accidentally touches the sealing unit 820.

More importantly, when the medical staff tears off the protective piece 830, the protective piece 830 will expand under the pulling force of the medical staff in the radial direction, so the contact area between the inner wall of the protective piece 830 and the degradable part 812 outside the main body 810 will be reduced as much as possible, so that when the protective piece 830 is torn off, the main body 810 can be effectively prevented from being driven and sliding out of the surgical channel. Accordingly, the inner end portion 8102 of the main body 810 is always kept in the patient's postoperative internal organs, thereby ensuring that the observation channel 8101 is unobstructed.

Preferably, the outer end of the protective member 830 forms at least two force-applying arms separated from each other, so that the medical staff can subsequently apply force to the protective member 830 to tear off the protective member 830. A partition is formed between two adjacent pre-tear lines, wherein the outer end of each partition is connected to one of the force-applying arms. Preferably, the protective member 830 has three or more pre-tear lines along its extending direction.

It is worth mentioning that the protective member 830 has a predetermined strength so that after the main body 810 is covered by the protective member 830, The bendable section 815 on the main body 810 is constrained by the protective member 830 and is aligned with other parts of the main body 810, so that it is convenient for medical personnel to smoothly insert the part of the medical observation channel forming assembly 8100 that needs to be inserted into the surgical channel. In other words, the protective member 830 can also play the function of straightening the bendable section 815.

Preferably, in order to facilitate the subsequent tearing off of the protective member 830 , only a portion of the bendable section 815 is covered by the protective member 830 , while the inner end portion 8102 is not covered by the protective member 830 .

It is worth mentioning that the cross-sectional diameter of the protective member 830 is larger than the cross-sectional diameter of the main body 810, so that the protective member 830 can be sleeved on the main body 810. In one embodiment, since the expansion sac 813 can expand radially, when the protective member needs to be sleeved on the outside of the main body 810, the fluid in the cavity 81301 of the expansion sac 813 can be discharged first, so that the cross-sectional size of the main body 810 as a whole is smaller than the size of the inner channel formed by the protective member 830, so that the protective member 830 can be sleeved on the main body 810. Subsequently, by injecting fluid into the cavity 81301, the protective member 830 can be relatively fixed to the protective member 830. When the protective member 830 needs to be torn off later, the fluid in the cavity 81301 can be discharged again, so that the protective member 830 can be torn off from the surgical channel and the outside of the main body 810.

Furthermore, the medical observation channel forming component 8100 also includes a guide member 840, wherein the cross-sectional diameter of the guide member 840 is smaller than the cross-sectional diameter of the observation channel 8101 of the main body 810, so that the guide member 840 can pass through the observation channel 8101 of the main body 810.

It is worth mentioning that after the surgical channel is created, the guide 840 can be first inserted into the surgical channel to establish a guide line between the patient's postoperative internal organs and the outside world. Subsequently, the observation channel 8101 of the main body 810 is kept coaxial with the guide 840, and the guide 840 gradually penetrates the observation channel 8101 from the endoscope port 81011 until the inner end 8102 forming the endoscope port 81011 is inserted into the patient's postoperative internal organs.

Then, the guide member 840 is pulled off, and the protective member 830 is torn off. In this way, a smooth observation channel 8101 can be formed between the postoperative internal organs of the patient and the outside world.

It can be understood that since the guide piece 840 is set to establish the guide line between the patient's postoperative internal organs and the outside world, during the process of the guide piece 840 gradually penetrating from the endoscope port 81011 into the observation channel 8101, the main body 810 will not deviate excessively from the surgical channel due to the restriction of the guide piece 840. As a result, the tissue forming the surgical channel on the patient's body will not be punctured by the main body 810 that deviates excessively from the extension direction of the surgical channel.

It can be understood that the non-degradable portion 811 of the main body 810 forms the observation channel 8101. Therefore, as long as the inner end portion 8102 of the main body 810 can be maintained in the patient's postoperative internal organs, there is always an unobstructed observation channel between the patient's postoperative internal organs and the outside world, which can be used by medical staff for endoscopy.

In addition, the non-degradable portion 811 is coated with at least one radially deformable portion. The radially deformable portion can expand radially relative to the non-degradable portion 811 to compress the tissue forming the surgical channel on the patient to prevent excessive bleeding when the main body 810 is kept in the surgical channel.

In one embodiment, the radially deformable portion is implemented as a medical material that is coated on the outside of the non-degradable portion 811 and can absorb liquid and expand. In this way, the radially deformable portion can not only absorb the blood flowing out of the tissue forming the surgical channel on the patient's body, but also press the tissue forming the surgical channel on the body to prevent excessive bleeding. Preferably, the radially deformable portion is also implemented as a biodegradable material, so that the radially deformable portion can not only press to stop bleeding, but also will not affect the patient's postoperative recovery after the surgical channel is established.

In another embodiment, the radially deformable portion is implemented as the expansion sac 813, wherein the expansion sac 813 is coated on the main body 810. A predetermined amount of fluid, such as gas, liquid, etc., can be injected into the cavity 81301 formed by the expansion sac 813, so that the expansion sac 813 can expand radially, thereby pressing the tissue on the patient's body that forms the surgical channel to prevent excessive bleeding.

Preferably, the radially deformable portion may further include the support portion 814 coated on the outer wall of the expansion bladder 813. More preferably, the radially deformable portion may further include the degradable portion 812 coated on the outermost side.

It should be understood by those skilled in the art that the embodiments of the present invention described above and shown in the accompanying drawings are only examples and do not limit the present invention. The purpose of the present invention has been fully and effectively achieved. The functional and structural principles of the present invention have been demonstrated and explained in the embodiments, and the embodiments of the present invention may be deformed or modified in any way without departing from the principles.

Claims (30)

An adjustable postoperative safety tube, used for inserting into a surgical fistula after surgery, characterized in that the adjustable postoperative safety tube comprises: A safety tube body, wherein the safety tube body is hollow and made of a degradable material, and the safety tube body is used to define a safety passage in the surgical fistula; an inner extension, wherein the inner extension is connected to a front end of the safety tube body, and an inner opening of the safety channel is located at a head of the inner extension; and An adjustable component, wherein the adjustable component includes a limiter mounted in an adjustably mounted position on the rear end of the safety tube body, and is used to restrictively change the length of the safety tube body that is allowed to be inserted into the surgical fistula by adjusting the mounting position of the limiter. The adjustable postoperative safety tube according to claim 1, wherein the limiter of the adjustable component comprises a sleeve portion adjustably sleeved on the safety tube body and a stopper portion extending laterally outward from the sleeve portion. The adjustable postoperative safety tube according to claim 2, wherein the sleeve portion of the limit member is interference fit with the safety tube body. The adjustable postoperative safety tube according to claim 2, wherein the stopper further comprises a fastener, and the fastener is used to fix the sleeve portion to a predetermined position of the safety tube body. The adjustable postoperative safety tube as described in claim 4, wherein the stop portion of the limit member extends outward from the front end of the sleeve portion as a whole, and the fastener is screwed to the rear end of the sleeve portion to increase the squeezing force of the sleeve portion on the safety tube body through the fastener. The adjustable postoperative safety tube as described in claim 5, wherein the limit member further includes a cushion, wherein the cushion is arranged between the sleeve portion and the safety tube body to increase the friction between the sleeve portion and the safety tube body. The adjustable postoperative safety tube as described in claim 6, wherein the fastener includes an annular base, an outer peripheral arm extending integrally from the outer periphery of the annular base, and an inner peripheral arm extending integrally from the inner periphery of the annular base, wherein the outer peripheral arm and the inner peripheral arm extend longitudinally in the same direction from the annular base to form a fastening groove matched with the rear end of the sleeve portion between the outer peripheral arm and the inner peripheral arm, and when the rear end of the sleeve portion is inserted into the fastening groove of the fastener for threaded connection, the inner peripheral arm of the fastener extends into the gap between the sleeve portion and the safety tube body to contact the gasket. An adjustable postoperative safety tube as described in claim 7, wherein the inner peripheral arm of the fastener has an inclined end surface facing the safety tube body, and when the fastener is screwed together with the sleeve portion, the inclined end surface of the inner peripheral arm abuts against the side surface of the cushion to squeeze the cushion toward the safety tube body. The adjustable postoperative safety tube according to any one of claims 3 to 8, wherein the adjustable component further comprises a blocking member suitable for blocking the in vitro opening of the safety channel, and the blocking member is flexibly connected to the stop portion of the limiting member. The adjustable postoperative safety tube as described in claim 2, wherein the adjustable component further includes a blocking piece suitable for blocking the extracorporeal opening of the safety channel, and the blocking piece is integrally connected to the sleeve portion of the limiting member, wherein the blocking piece is located inside the sleeve portion, so that the adjustable component has a cap-like structure, and the blocking piece has an interference fit with the safety tube body. The adjustable postoperative safety tube according to any one of claims 2 to 8, wherein the adjustable component further comprises an adhesive layer, and the adhesive layer is disposed on the front side of the stop portion of the limiting member. The adjustable postoperative safety tube according to any one of claims 1 to 8, wherein hemostatic drugs and/or anti-infective drugs are added to the safety tube body during the preparation process of the degradable material. The adjustable postoperative safety tube according to any one of claims 1 to 8, wherein the degradable material used to prepare the safety tube body is a water-swellable material; or, in the process of preparing the safety tube body from the degradable material, the water-swellable material is added. The method for using the adjustable postoperative safety tube is characterized by comprising the steps of: Inserting an adjustable postoperative safety tube into the surgical fistula, so that the inner extension of the adjustable postoperative safety tube is located in the internal organ; Adjusting the installation position of the adjustable component of the adjustable postoperative safety tube on the safety tube body of the adjustable postoperative safety tube to restrictively change the length of the safety tube body that is allowed to be inserted into the surgical fistula; and The safety tube body is degraded so that the outer diameter of the safety tube body decreases as the surgical fistula tract heals and shrinks. The method for using the adjustable postoperative safety tube according to claim 14, further comprising the steps of: The safety tube is expanded so that the outer diameter of the safety tube becomes larger to match the initial inner diameter of the surgical fistula. A medical observation channel forming component, characterized in that the medical observation channel forming component includes a main body, wherein the main body has an inner end and an outer end, wherein the main body has a non-degradable portion and a radially deformable portion coated on the outside of the non-degradable portion, wherein the non-degradable portion forms an observation channel between the inner end and the outer end, and an inner port and an outer port are respectively formed at the inner end and the outer end, both of which are connected to the observation channel. According to the medical observation channel forming component of claim 16, the radially deformable portion is implemented as a degradable portion, wherein the degradable portion is implemented as a material that can be absorbed by a biological body. According to the medical observation channel forming component according to claim 16, the radially deformable portion is implemented as at least one expansion sac, wherein the expansion sac forms a cavity, wherein the expansion sac is coated on the outside of the non-degradable portion, and wherein the radial size of the expansion sac is configured to vary with the amount of fluid filled into the cavity. According to the medical observation channel forming assembly according to claim 18, the direction in which the cavity extends between the inner end and the outer end is coaxial with the direction in which the non-degradable portion extends. According to the medical observation channel forming assembly according to claim 16, a bendable section is formed on the main body between the inner end portion and a predetermined position away from the inner end portion, and the bendable section is configured to be bendable in a natural state. According to the medical observation channel forming component of claim 16, an anti-blocking groove is formed on the main body between the inner end portion and a predetermined position away from the inner end portion, and the anti-blocking groove is arranged to be connected to the observation channel. According to the medical observation channel forming component according to any one of claims 16 to 21, at least one expandable stop portion is formed on the circumferential side of the main body at a predetermined distance from the inner end portion, and the stop portion forms a fluid cavity, wherein the stop portion is configured to radially expand to a radial size greater than the radial size of other parts of the main body after a predetermined amount of fluid is injected into the fluid cavity, and radially contract to a radial size smaller than the radial size of other parts of the main body after the fluid in the fluid cavity is discharged. According to the medical observation channel forming component of claim 18, at least one expandable stop portion is formed on the circumferential side of the main body at a predetermined distance from the inner end portion, and the stop portion forms a fluid cavity, wherein the stop portion is configured to radially expand to a radial size greater than the radial size of other parts of the main body after a predetermined amount of fluid is injected into the fluid cavity, and radially contract to a radial size smaller than the radial size of other parts of the main body after the fluid in the fluid cavity is discharged, and the fluid cavity is configured to be connected to the cavity. According to the medical observation channel forming component of claim 17, the degradable part is made of a material that is absorbed by a living body and can swell by absorbing liquid. A medical observation channel forming component, characterized in that the medical observation channel forming component includes a main body, wherein the main body has an inner end and an outer end, wherein the main body has a non-degradable part and a radially deformable part coated on the outside of the non-degradable part, wherein the non-degradable part forms an observation channel between the inner end and the outer end, and an inner port and an outer port are respectively formed at the inner end and the outer end, both of which are connected to the observation channel, wherein the radially deformable part is implemented as a degradable part, wherein the degradable part is implemented as a material that can be absorbed by a biological body, and at least one expansion sac is arranged between the degradable part and the non-degradable part, wherein the expansion sac forms a cavity, wherein the radial size of the expansion sac is arranged to change with the amount of fluid filled into the cavity, so as to drive the degradable part coated on the outside of the expansion sac to move radially together. According to the medical observation channel forming assembly of claim 25, at least one supporting portion is provided between the outer wall of the expansion sac and the degradable portion, the inner side of the supporting portion is connected to the outer wall of the expansion sac, and the outer side of the supporting portion is connected to the degradable portion, and the strength of the supporting portion is greater than the strength of the degradable portion. According to the medical observation channel forming component according to claim 16, 17, 18, 19, 20, 21, 23, 24, 25 or 26, the medical observation channel forming component comprises a protective member, wherein the protective member is detachably covered on the outer wall of the main body. According to the medical observation channel forming assembly of claim 27, at least two pre-tear marks are formed between the two ends of the protective member. According to the medical observation channel forming assembly of claim 28, a partition is formed between two adjacent pre-tear lines, wherein the outer end of each of the partitions is respectively connected to a force applying arm. According to the medical observation channel forming component of claim 25, the degradable part comprises chitosan.