Gastric bypass stent conveying device with externally adjusted rigidity and stent conveying system

Abstract

The invention discloses a stomach bypass stent conveying device with externally-adjusted rigidity and a stent conveying system, and relates to the field of medical instruments. The device comprises a small release ball, a storage tube, an outer tube, a handle and a rigidity regulator, the rigidity adjuster comprises an outer sleeve and an air pipe, the outer sleeve comprises a first adjusting pipe and a second adjusting pipe which are coaxially arranged, the second adjusting pipe is sleeved with the first adjusting pipe, an outer sleeve inner cavity is formed between the first adjusting pipe and the second adjusting pipe, and the air pipe is communicated with the outer sleeve inner cavity so that the outer sleeve inner cavity can be inflated or vacuumized. The second adjusting pipe is slidably arranged on the outer pipe in a sleeving mode. When the inner cavity of the outer sleeve is filled with air, the stomach bypass stent conveying device with externally adjusted rigidity is in a flexible state; when the inner cavity of the outer sleeve is vacuumized, the stomach bypass stent conveying device with the externally-adjusted rigidity is in a rigid state. The rigidity of the gastric bypass stent conveying device is adjusted by adjusting the vacuum state in the inner cavity of the outer sleeve, and the storage tube can conveniently enter a scotodoor.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and more particularly, to a gastric bypass stent delivery device and a stent delivery system with externally adjustable stiffness. Background Art

[0002] In existing gastric bypass stent delivery devices, the delivery device needs to first pass through the patient's pharynx, and then pass through the esophagus, cardia, and stomach and finally reach the duodenal pylorus. Since it needs to pass through the pharynx, most components of the delivery device are designed as flexible parts to protect the patient's pharynx and esophagus. However, when the front end of the delivery device enters the stomach, although the flexible part can effectively protect the patient's pharynx and esophagus, it is of no help for the gastric bypass stent delivery device to smoothly enter the pylorus. The greater curvature of the stomach of obese patients is more curved than that of normal people. When the front end of the delivery device enters the stomach, the design of the flexible part will inevitably cause the outer tube of the device to travel along the greater curvature of the patient's stomach ( Figure 1 as shown in (a) of the figure). Once the outer tube of the delivery device travels along the greater curvature of the stomach, the force externally applied to the delivery device will only cause the outer tube to continue to coil in the stomach, rather than continue to push the receiving tube into the pylorus, and the force cannot be effectively transmitted, bringing great inconvenience to the surgical operation.

[0003] The current clinical solution is to use a foreign body forceps to clamp the green part of the receiving tube to increase the system rigidity so as to achieve the pushing of the receiving tube and finally reach the pylorus. Using a foreign body forceps to push the receiving tube has certain skills in clinical use. Clamping the green connection cap with a foreign body forceps will increase the operation difficulty and time, requiring a longer operation time. At the same time, an additional medical staff is needed to operate the foreign body forceps.

[0004] In view of this, the present application is specifically proposed. Summary of the Invention

[0005] The object of the present application is to provide a gastric bypass stent delivery device and a stent delivery system with externally adjustable stiffness. The gastric bypass stent delivery device and the stent delivery system with externally adjustable stiffness can adjust the stiffness of the gastric bypass stent delivery device by adjusting the vacuum state in the inner cavity of the outer sleeve tube, facilitating the gastric bypass stent delivery device to be in a flexible state when passing through positions such as the patient's pharynx, esophagus, cardia, and stomach, and being in a rigid state when it needs to enter the pylorus, so that the pushing force applied from the outer tube at the handle end can be well transmitted to the receiving tube, making it easier for the receiving tube to enter the pylorus.

[0006] To achieve the above object, in a first aspect, the present invention provides an externally adjustable stiffness gastric bypass stent delivery device, which includes a release ball, a receiving tube, an outer tube, a handle, and a stiffness adjuster; the cylindrical end of the release ball is inserted into the receiving tube, a stent pusher is slidably arranged in the receiving tube, the release ball is connected to a membrane tube on the stent pusher through a dissolvable inner core, the receiving tube is connected to the outer tube, and the outer tube is connected to the handle;

[0007] The stiffness adjuster includes an outer sleeve and an air tube. The outer sleeve includes a first adjustment tube and a second adjustment tube arranged coaxially. The first adjustment tube is sleeved on the second adjustment tube, and an inner cavity of the outer sleeve is formed between the first adjustment tube and the second adjustment tube. The air tube is communicated with the inner cavity of the outer sleeve to facilitate inflation or vacuum extraction into the inner cavity of the outer sleeve. The second adjustment tube is slidably sleeved on the outer tube;

[0008] When the inner cavity of the outer sleeve is filled with air, the externally adjustable stiffness gastric bypass stent delivery device is in a flexible state; when the inner cavity of the outer sleeve is evacuated, the externally adjustable stiffness gastric bypass stent delivery device is in a rigid state.

[0009] In an optional embodiment, the stiffness adjuster further includes a sleeve base, which is arranged at one end of the outer sleeve and away from the receiving tube. The sleeve base is provided with a ventilation hole and a shielding piece for opening or closing the ventilation hole. The ventilation hole is communicated with the inner cavity of the outer sleeve, and the ventilation hole is communicated with the air tube.

[0010] In an optional embodiment, a control knob is rotatably installed on the sleeve base, the shielding piece is connected to the control knob, and the control knob drives the shielding piece to shield or open the ventilation hole.

[0011] In an optional embodiment, the sleeve base is provided with a base groove, the ventilation hole is arranged in the base groove, and the shielding piece rotates in the base groove.

[0012] In an optional embodiment, a Luer connector is connected to one end of the air tube away from the ventilation hole, and the Luer connector is used to connect to a negative pressure aspirator.

[0013] In an optional embodiment, the materials of the first adjustment tube and the second adjustment tube are independently selected from TPU or TPE, and the elastic moduli of the first adjustment tube and the second adjustment tube are both 20 - 100 Mpa.

[0014] In an optional embodiment, the stiffness adjuster further includes a guiding head, which is connected to the end of the outer sleeve and close to the receiving tube.

[0015] In an alternative embodiment, the adjustable-rigidity gastric bypass stent delivery device further includes a handle and an internal sliding rod for pushing the stent pusher block. The internal sliding rod has a hollow structure and sequentially passes through and is slidably disposed within the handle, the outer tube, and the receiving tube. One end of the internal sliding rod is fixedly connected to the handle, and the other end is fixedly connected to the stent pusher block. The adjusting core rod is selectively inserted into the internal sliding rod.

[0016] In an alternative embodiment, the handle is provided with a knob and a locking wire. The outer tube is a double-channel tube, which includes a coaxially arranged outer tube wall and an inner tube wall. A first hollow channel for the locking wire to pass through is formed between the outer wall of the outer tube wall and the inner tube wall. The inner tube wall encloses a second hollow channel for the internal sliding rod to pass through. One end of the locking wire is fixed to the knob, and the other end passes through the first hollow channel and is connected to the release ball.

[0017] In a second aspect, the present invention provides a stent delivery system, which includes a gastroscope, a guide wire, and the adjustable-rigidity gastric bypass stent delivery device according to any one of the foregoing embodiments. The gastroscope is used to guide the guide wire, and after the gastroscope is withdrawn, the guide wire cooperates with the central cavity of the release ball of the adjustable-rigidity gastric bypass stent delivery device and guides the movement of the adjustable-rigidity gastric bypass stent delivery device.

[0018] The beneficial effects of the present invention include:

[0019] Through the above technical solutions, the adjustable-rigidity gastric bypass stent delivery device provided by the present invention introduces a rigidity regulator, and uses the inner cavity of the outer sleeve formed between the first adjusting tube and the second adjusting tube to adjust the rigidity of the rigidity regulator. Since the rigidity regulator is sleeved on the outer tube, the rigidity of the outer tube can be adjusted, and it is easier to transmit the pushing force applied to the outer tube at the handle end to the receiving tube. When the rigidity regulator is in a flexible state, the gastric bypass stent delivery device is in a flexible state, which has a protective effect on the patient's pharynx and esophagus. When the rigidity regulator is in a rigid state, the outer tube of the gastric bypass stent delivery device changes from a flexible part to a relatively rigid part. After the rigidity of the gastric bypass stent delivery device is improved, the pushing force applied from the outer tube at the handle end can be well transmitted to the receiving tube, making it easier for the receiving tube to enter the pylorus. The present invention simplifies the operation steps and reduces the operation time of doctors.

[0020] Other features and advantages of the present application will be described in detail in the subsequent specific implementation section. Brief Description of the Drawings

[0021] To more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the accompanying drawings required in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and therefore should not be regarded as a limitation of the scope. For those of ordinary skill in the art, without creative efforts, other related drawings can also be obtained based on these drawings.

[0022] Figure 1 It is a simulation schematic diagram when the receiving tube enters the pylorus of the patient. Among them, (a) is a simulation schematic diagram when the receiving tube and the outer tube travel along the greater curvature of the patient's stomach, and (b) is a simulation schematic diagram of the ideal pushing angle when the receiving tube and the outer tube enter the patient's pylorus;

[0023] Figure 2 It is a schematic diagram of the stiffness regulator assembled on the outer tube in the gastric bypass stent delivery device with externally adjustable stiffness provided by the embodiment of the present application;

[0024] Figure 3 It is a schematic diagram of the stiffness regulator not assembled on the outer tube in the gastric bypass stent delivery device with externally adjustable stiffness provided by the embodiment of the present application;

[0025] Figure 4 It is a schematic diagram of the structure of the stiffness regulator in the gastric bypass stent delivery device with externally adjustable stiffness provided by the embodiment of the present application;

[0026] Figure 5 It is a schematic diagram of the structure of the stiffness regulator in a flexible state in the gastric bypass stent delivery device with externally adjustable stiffness provided by the embodiment of the present application;

[0027] Figure 6 It is Figure 5 The sectional view at A-A in;

[0028] Figure 7 It is a schematic diagram of the structure of the stiffness regulator in a rigid state in the gastric bypass stent delivery device with externally adjustable stiffness provided by the embodiment of the present application;

[0029] Figure 8 It is Figure 7 The sectional view at A-A in;

[0030] Figure 9 It is the stiffness evaluation test model diagram of the experimental example of the present application.

[0031] Icons: 10 - release ball; 20 - storage tube; 30 - locking wire; 40 - connecting cap; 50 - stiffness adjuster; 501 - guiding head; 502 - outer sleeve; 5021 - first adjusting tube; 5022 - second adjusting tube; 503 - sleeve base; 504 - control knob; 505 - air tube; 506 - Luer connector; 507 - inner cavity of outer sleeve; 508 - ventilation hole; 509 - shielding piece; 510 - base groove; 60 - outer tube; 70 - handle; 80 - knob; 90 - inner sliding rod; 100 - handle. Detailed implementation manners

[0032] To make the objectives, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of them. Usually, the components of the embodiments of the present application described and illustrated in the accompanying drawings here can be arranged and designed in various different configurations.

[0033] In the description of the present application, it should be noted that the orientation or positional relationship indicated by terms such as "inner" and "outer" is based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this application is usually placed during use. It is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present application. In addition, terms such as "first" and "second" are only used for descriptive distinction and cannot be understood as indicating or implying relative importance.

[0034] In the description of the present application, it should also be noted that unless otherwise clearly specified and defined, the terms "arrangement" and "connection" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present application can be understood according to specific situations.

[0035] Please refer to Figure 2 and Figure 3 , the present application provides a gastric bypass stent delivery device with externally adjustable stiffness, which includes a release ball 10, a storage tube 20, an outer tube 60, a handle 70 and a handle 100.

[0036] The cylindrical end of the release ball 10 is inserted into the receiving tube 20. A bracket push block is slidably arranged in the receiving tube 20. The release ball 10 is connected to the membrane tube on the bracket push block through a dissolvable inner core. The receiving tube 20 is connected to the outer tube 60, and the outer tube 60 is connected to the handle 70. The handle 100 is located at one end of the handle 70 away from the outer tube 60. The handle 70 and the handle 100 are not directly connected, and the handle 100 can move within a certain range. The connections described in this application can be glue bonding, threaded connection, or mechanical press-fit connection.

[0037] Among them, the release ball 10 has a spherical structure, and one end thereof is provided with a cylindrical end for inserting into the receiving tube 20 to block the covered stent in the receiving tube 20. The release ball 10 and the receiving tube 20 are in clearance fit. The release ball 10 can be separated from the receiving tube 20 under the push of an external force to achieve the unlocked state. The locked state means that the release ball 10 remains fixed at the end of the receiving tube 20 and cannot be separated by an external force. The unlocked state means that the release ball 10 and the end of the receiving tube 20 can be separated under the action of an external force.

[0038] In this embodiment, a covered stent (not shown in the figure) and a bracket push block are arranged in the receiving tube 20. The covered stent is installed on the bracket push block, and the membrane tube on the covered stent is connected to the release ball 10 through a dissolvable inner core.

[0039] The outer tube 60 is a double-channel pipe, which includes an outer tube 60 wall (not labeled in the figure) and an inner tube wall (not labeled in the figure) arranged coaxially. A first hollow channel (not labeled in the figure) for the locking wire 30 to pass through is formed between the outer wall of the outer tube 60 wall and the inner tube wall, and the inner tube wall forms a second hollow channel (not labeled in the figure) for the internal sliding rod 90 to pass through. The receiving tube 20 and the outer tube 60 are connected through a connecting cap 40.

[0040] The handle 70 is used to lock and release the release ball 10. Specifically, a knob 80 and a locking wire 30 are arranged on the handle 70. One end of the locking wire 30 is fixed to the knob 80, and the other end passes through the first hollow channel and is connected to the release ball 10. When the knob 80 fixes the locking wire 30, at this time, the relative position of the release ball 10 is fixed, the release ball 10 remains fixed at the end of the receiving tube 20, and an external force cannot separate them, presenting a locked state. When it is necessary to release the release ball 10, turn the knob 80 to open it. At this time, the locking wire 30 is in a free state, and the release ball 10 can be released by pushing the internal sliding rod 90 of the handle 100, presenting an unlocked state.

[0041] The handle 100 is used to push the bracket push block under the action of an external force. An internal sliding rod 90 is fixedly arranged inside the handle 100. The internal sliding rod 90 is of a hollow structure and sequentially passes through and is slidably arranged inside the handle 70, the outer tube 60, and the receiving tube 20. One end of the internal sliding rod 90 is fixedly connected to the handle 100, and the other end is fixedly connected to the bracket push block. The connection between the internal sliding rod 90 and the handle 100 and the bracket push block can be integrally formed by injection molding, glued connection, etc. During operation, the handle 100 can drive the internal sliding rod 90 to move inside the handle 70, the outer tube 60, and the receiving tube 20, thereby pushing the pushing bracket inside the receiving tube 20 to slide inside the receiving tube 20, and further realizing the release of the small ball 10.

[0042] Due to the relatively soft structure and material, the force transmitted from the outside to the conveying device only causes the outer tube 60 to continue to coil inside the stomach, rather than continuing to push the receiving tube 20 into the pylorus.

[0043] Therefore, the present application introduces a stiffness regulator 50, which can adjust the stiffness of the gastric bypass stent delivery device, facilitating the gastric bypass stent delivery device to be in a flexible state when passing through positions such as the patient's pharynx, esophagus, cardia, and stomach, and being in a rigid state when it needs to enter the pylorus. The pushing force applied from the handle 70 end to the outer tube 60 can be well transmitted to the receiving tube 20, making it easier for the receiving tube 20 to enter the pylorus.

[0044] Specifically, please refer to Figure 4 and Figure 5 , the stiffness regulator 50 includes an outer sleeve 502 and an air tube 505. The outer sleeve 502 includes a first adjustment tube 5021 and a second adjustment tube 5022 arranged coaxially. The first adjustment tube 5021 is sleeved on the second adjustment tube 5022. An outer sleeve inner cavity 507 is formed between the first adjustment tube 5021 and the second adjustment tube 5022. The air tube 505 is communicated with the outer sleeve inner cavity 507 to facilitate inflation or vacuum extraction into the outer sleeve inner cavity 507. The second adjustment tube 5022 is slidably sleeved on the outer tube 60. One end of the air tube 505 away from the ventilation hole 508 is connected with a Luer connector 506, and the Luer connector 506 is used to connect a negative pressure aspirator.

[0045] Please refer to Figure 5 and Figure 6 , when the outer sleeve inner cavity 507 is filled with air, the gastric bypass stent delivery device with externally adjustable stiffness is in a flexible state; please refer to Figure 7 and Figure 8 , when the outer sleeve inner cavity 507 is evacuated, the gastric bypass stent delivery device with externally adjustable stiffness is in a rigid state.

[0046] In this embodiment, the inner cavity 507 of the outer sleeve formed between the first adjusting tube 5021 and the second adjusting tube 5022 is used to adjust the stiffness of the stiffness adjuster 50. Since the stiffness adjuster 50 is sleeved on the outer tube 60, the stiffness of the outer tube 60 can be adjusted, and it is easier to transmit the pushing force applied to the outer tube 60 at the handle 70 end to the receiving tube 20. Among them, the materials of the first adjusting tube 5021 and the second adjusting tube 5022 are independently selected from TPU or TPE, and the elastic modulus of both the first adjusting tube 5021 and the second adjusting tube 5022 is 20 - 100 Mpa.

[0047] Among them, the vacuum state in the inner cavity 507 of the outer sleeve can be adjusted through the air tube 505. For example, when no vacuum is pumped, the inner cavity 507 of the outer sleeve is naturally filled with air, which can make the outer sleeve 502 have a certain flexibility and facilitate its passage through the throat. When the inner cavity 507 of the outer sleeve is evacuated, the first adjusting tube 5021 is tightly adsorbed on the surface of the second adjusting tube 5022, improving the density of the second adjusting tube 5022, thereby enhancing the stiffness of the outer sleeve 502 and facilitating its passage through the pylorus.

[0048] In some embodiments, the stiffness adjuster 50 further includes a sleeve base 503. The sleeve base 503 is disposed at one end of the outer sleeve 502 and away from the receiving tube 20. An air vent 508 and a shielding piece 509 for opening or closing the air vent 508 are provided on the sleeve base 503. The air vent 508 is communicated with the inner cavity 507 of the outer sleeve, the air vent 508 is communicated with the air tube 505, and the air tube 505 is fixedly connected to the sleeve base 503. The connection methods include but are not limited to threaded connection, glue bonding, or welding.

[0049] The arrangement of the air vent 508 and the shielding piece 509 on the sleeve base 503 can better control the vacuum condition in the inner cavity 507 of the outer sleeve. Among them, by using one air vent 508, the inner cavity 507 of the outer sleeve can be inflated or evacuated through the air vent 508, and at the same time, it is convenient to use the shielding piece 509 to close the air vent 508, and the operation is simpler.

[0050] There are various control methods and structures for the shielding piece 509. For example, manual control, or the rotation, sliding, etc. of the shielding piece 509 are used to open and close the air vent 508.

[0051] In this embodiment, a typical but non-limiting example is provided. A control knob 504 is rotatably mounted on the sleeve base 503. The shielding piece 509 is connected to the control knob 504. The control knob 504 can rotate relative to the sleeve base 503, thereby driving the shielding piece 509 to shield or open the ventilation hole 508. The control knob 504 can control whether a passage is formed between the trachea 505 and the inner cavity 507 of the outer sleeve. When no passage can be formed, the outer sleeve 502 is in a flexible state. When a passage is formed, a vacuum can be drawn inside the outer sleeve 502, and at this time, the outer tube 60 becomes rigid.

[0052] Furthermore, in order to limit the movement trajectory of the shielding piece 509, in this embodiment, a base groove 510 is further provided on the sleeve base 503. The ventilation hole 508 is provided in the base groove 510, and the shielding piece 509 rotates in the base groove 510. By providing the base groove 510, it is possible to prevent the rotation angle and range of the control knob 504 from being too large. At the same time, the base groove 510 can be used to prevent the shielding piece 509 from protruding, making it more aesthetically pleasing.

[0053] Furthermore, the stiffness regulator 50 further includes a guiding head 501. The guiding head 501 is connected to the end of the outer sleeve 502 and is close to the receiving tube 20. The setting of the guiding head 501 can cooperate with the gastric bypass stent delivery device with externally adjustable stiffness to better enter the patient's body.

[0054] The working principle of the gastric bypass stent delivery device with externally adjustable stiffness provided in this embodiment is as follows: During use, the outer tube 60 surface of the gastric bypass stent delivery device with externally adjustable stiffness is sleeved with the stiffness regulator 50. At this time, the stiffness regulator 50 is not evacuated and is in a flexible state. The design of its flexible body can help the gastric bypass stent delivery device with externally adjustable stiffness protect the patient's pharynx and esophagus and enter the patient's stomach. When the receiving tube 20 reaches the stomach, the Luer connector 506 of the stiffness regulator 50 is connected to a vacuum aspirator for evacuation. After evacuation, the stiffness regulator 50 changes into a rigid body, so the rigidity of the entire delivery device can be improved. After the rigidity of the gastric bypass stent delivery device with externally adjustable stiffness is improved, the pushing force applied from the outer tube 60 at the handle 70 end can be well transmitted to the receiving tube 20, making it easier for the receiving tube 20 to enter the pyloric orifice.

[0055] Experimental Example

[0056] The present invention adopts Figure 9A stiffness evaluation test model is provided, that is, a certain span is set for the conveyor outer tube 60, the conveyor outer tube 60 is fixed at one end of the test model, and the other end is in a slidable state. A force is applied in the middle of the conveyor outer tube 60. When the conveyor outer tube 60 is displaced downward by 10 mm, the force value applied by the tensile tester is recorded at this time. The so-called stiffness is the ability of a product to resist deformation. In this paper, the difference in rigidity is evaluated by comparing the reaction force of different schemes on the test machine under the same test conditions. Among them, the gastric bypass stent delivery device provided in an embodiment of the present invention when the stiffness regulator 50 is used is used as an example, and the gastric bypass stent delivery device when the stiffness regulator 50 is not used is used as a comparative example.

[0057]

[0058]

[0059] It can be seen from the above table that after the implementation of the present invention, the average value of the force resisting deformation when the outer tube 60 of the conveyor moves downward by 10 mm is 17.04 N, while the average value of the force resisting deformation when the outer tube 60 of the conveyor without the stiffness adjuster 50 moves downward by 10 mm is 8.77 N. It can be seen that the stiffness enhancement method of the present invention has significantly improved the force resisting deformation compared with the previous method.

[0060] In summary, the gastric bypass stent delivery device with externally adjusted stiffness provided by the present invention introduces a stiffness regulator 50, and uses the outer sleeve inner cavity 507 formed between the first adjustment tube 5021 and the second adjustment tube 5022 to adjust the stiffness of the stiffness regulator 50. Since the stiffness regulator 50 is sleeved on the outer tube 60, the stiffness of the outer tube 60 can be adjusted, and it is easier to transfer the pushing force applied by the outer tube 60 at the handle 70 end to the receiving tube 20. When the stiffness regulator 50 is in a flexible state, the gastric bypass stent delivery device is in a flexible state, which has a protective effect on the patient's throat and esophagus. When the stiffness regulator 50 is in a rigid state, the outer tube 60 of the gastric bypass stent delivery device is changed from a flexible part to a partially rigid part. After the rigidity of the gastric bypass stent delivery device is improved, the pushing force applied by the outer tube 60 at the handle 70 end can be well transmitted to the receiving tube 20, so that the receiving tube 20 can enter the pyloric orifice more easily. The present invention simplifies the operation steps and reduces the doctor's operation time. The stiffness regulator 50 of the present invention is designed with an outer sleeve 502, a control knob 504, an trachea 505 and a Luer connector 506. The control knob 504 can control whether the trachea 505 and the inner cavity 507 of the outer sleeve form a passage. When the passage cannot be formed, the outer sleeve 502 is in a flexible state. When the passage is formed, the outer sleeve 502 can be evacuated into a vacuum, and the outer tube 60 is in a rigid state. The front end of the stiffness regulator 50 of the present invention is designed with a guide head 501, which can be used in conjunction with a delivery system to better enter the patient's body.

[0061] It should be noted that, without conflict, the features in the embodiments of the present application may be combined with each other.

[0062] The above are only the preferred embodiments of the present application, and are not intended to limit the present application. For those skilled in the art, the present application may have various changes and modifications. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included within the protection scope of the present application.

Claims

1. An external stiffness-adjustable gastric bypass stent delivery device, characterized in that, It includes a release ball, a storage tube, an outer tube, a handle and a stiffness adjuster; the cylindrical end of the release ball is inserted into the storage tube, a bracket push block is slidably arranged in the storage tube, the release ball is connected to the membrane tube on the bracket push block through a dissolvable inner core, the storage tube is connected to the outer tube, and the outer tube is connected to the handle; The stiffness adjuster includes an outer sleeve tube and an air tube. The outer sleeve tube includes a first adjustment tube and a second adjustment tube arranged coaxially. The first adjustment tube is sleeved on the second adjustment tube, and an inner cavity of the outer sleeve tube is formed between the first adjustment tube and the second adjustment tube. The air tube is communicated with the inner cavity of the outer sleeve tube to facilitate inflation or vacuum extraction into the inner cavity of the outer sleeve tube. The second adjustment tube is slidably sleeved on the outer tube; When the inner cavity of the outer sleeve tube is filled with air, the gastric bypass stent delivery device with externally adjustable stiffness is in a flexible state; when the inner cavity of the outer sleeve tube is evacuated, the gastric bypass stent delivery device with externally adjustable stiffness is in a rigid state.

2. The adjustable stiffness gastric bypass stent delivery device according to claim 1, wherein The stiffness adjuster further includes a sleeve base, which is arranged at one end of the outer sleeve tube and away from the storage tube. An air vent and a shielding piece for opening or closing the air vent are arranged on the sleeve base. The air vent is communicated with the inner cavity of the outer sleeve tube, and the air vent is communicated with the air tube.

3. The adjustable stiffness gastric bypass stent delivery device according to claim 2, wherein A control knob is rotatably installed on the sleeve base. The shielding piece is connected to the control knob, and the control knob drives the shielding piece to shield or open the air vent.

4. The adjustable stiffness gastric bypass stent delivery device according to claim 2, wherein The sleeve base is provided with a base groove, the air vent is arranged in the base groove, and the shielding piece rotates in the base groove.

5. The adjustable stiffness gastric bypass stent delivery device according to claim 2, wherein One end of the air tube away from the air vent is connected with a Luer connector, and the Luer connector is used for connecting a negative pressure aspirator.

6. The adjustable stiffness gastric bypass stent delivery device according to claim 1, wherein The materials of the first adjustment tube and the second adjustment tube are independently selected from TPU or TPE, and the elastic moduli of the first adjustment tube and the second adjustment tube are both 20 - 100 Mpa.

7. The adjustable stiffness gastric bypass stent delivery device according to claim 1, characterized in that, The stiffness adjuster further includes a guide head, and the guide head is connected to the end of the outer sleeve tube and close to the storage tube.

8. The adjustable stiffness gastric bypass stent delivery device according to claim 1, wherein, The gastric bypass stent delivery device with externally adjustable stiffness further includes a handle and an internal sliding rod for pushing the bracket push block. The internal sliding rod is of a hollow structure and sequentially passes through and is slidably arranged in the handle, the outer tube and the storage tube. One end of the internal sliding rod is fixedly connected to the handle, and the other end is fixedly connected to the bracket push block. The adjustment core rod can be selectively inserted into the internal sliding rod.

9. The adjustable stiffness gastric bypass stent delivery device according to claim 8, characterized in that, A knob and a locking wire are arranged on the handle. The outer tube is a double-channel pipe, which includes an outer tube wall and an inner tube wall arranged coaxially. A first hollow channel for the locking wire to pass through is formed between the outer tube wall and the outer wall of the inner tube wall. The inner tube wall encloses a second hollow channel for the internal sliding rod to pass through. One end of the locking wire is fixed to the knob, and the other end passes through the first hollow channel and is connected to the release ball.

10. A stent delivery system, characterized in that, It includes a gastroscope, a guide wire, and an externally adjustable stiffness gastric bypass stent delivery device as described in any one of claims 1-9. The gastroscope is used to guide the guide wire. After the gastroscope is withdrawn, the guide wire cooperates with the central cavity of the release ball of the externally adjustable stiffness gastric bypass stent delivery device and guides the movement of the externally adjustable stiffness gastric bypass stent delivery device.

Images