Controllable dilatation muscular fascia release balloon catheter, liquid injection system and use method
By using a controllable expansion balloon catheter for myofascial release, combined with ultrasound guidance and a mesh-like tubular support structure, precise control of myofascial release is achieved, solving the problem of inappropriate myofascial expansion in traditional methods and improving treatment outcomes.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-16
- Publication Date
- 2026-04-03
AI Technical Summary
In treating myofascitis, existing techniques often fail to achieve complete release using traditional release methods, and may result in excessive fascial stretching or insufficient lateral release, thus affecting treatment outcomes.
A controllable dilatation myofascial release balloon catheter is used. With precise positioning guided by ultrasound, a liquid medium is injected into the balloon using an injection tool. Combined with a mesh tubular support structure, the balloon expansion direction is controlled to ensure an appropriate range of myofascial release.
It achieves precise and controllable myofascial release, avoiding excessive or insufficient expansion of the myofascia and improving treatment outcomes.
Smart Images
Figure CN121775299A_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of medical device technology, and in particular relates to a controllable dilatation myofascitis release balloon catheter, an injection system, and a method of use. Background Technology
[0002] Currently, the treatment of myofascitis requires the release of fascial adhesions. Traditional release methods include needle knife therapy and water separation techniques. However, needle knife therapy can only make "point-like cuts" at the fascial adhesions, resulting in a very narrow release range and making it difficult to comprehensively improve the fascial condition. As for water separation techniques, due to physical limitations, water tends to flow to areas with low resistance, preventing the water from reaching the truly adhered areas that urgently need release, while unadhesed areas that do not require intervention are flooded with water, thus failing to achieve effective release. In addition, traditional release methods sometimes result in excessive fascial stretching and over-release, while insufficient lateral release, thereby affecting the treatment effect. Therefore, existing techniques still have shortcomings and deficiencies. Summary of the Invention
[0003] The purpose of this invention is to provide a controllable dilatation myofascitis release balloon catheter, injection system, and method of use to solve the problems mentioned in the background art.
[0004] The technical solution adopted by the present invention to solve the above problems is as follows: A controllable dilatation myofascial release balloon catheter includes a catheter with a head end and a tail end. The head end of the catheter is fitted with a balloon, and the tail end of the catheter is fitted with a Y-type connector. The Y-type connector includes a main lumen tube with openings at both ends and a side lumen tube installed on the main lumen tube. A sealing cap is detachably installed at the end of the side lumen tube away from the main lumen tube. The catheter includes an inner tube and an outer tube arranged coaxially. One end of the inner tube extends to the outside of the outer tube, and the other end of the inner tube is sealed and fixedly connected to the outer tube and both are located inside the main lumen tube. The inner tube is connected to the main lumen tube, and the side lumen tube is connected to the inside of the outer tube. The balloon is located at the extension end of the inner tube. The balloon includes a mesh-like tubular support structure coaxially sleeved on the inner tube and made of woven fibers. A balloon body made of silicone material with openings at both ends is fixedly covered on the mesh-like tubular support structure. One end of the balloon body is fixedly connected to the end of the outer tube away from the Y-shaped connector, and the other end of the balloon body is sealed and fixedly connected to the extension end of the inner tube. A through hole is opened on the inner tube located inside the balloon body.
[0005] Furthermore, two spaced-apart radiopaque rings are fitted onto the inner tube inside the balloon.
[0006] Furthermore, the extension end of the inner tube is sealed and fixedly connected to the end of the balloon body by a sealing cap with imaging function.
[0007] Furthermore, the outer surface of the balloon body is coated with an anti-adhesion coating.
[0008] Furthermore, the above-mentioned controllable dilatation myofascitis release balloon catheter injection system includes an injection device, which includes an injection tube connected to the main lumen tube, and a push rod with a piston is slidably connected inside the injection tube.
[0009] Furthermore, the liquid outlet end of the injection tube is connected to a three-way connector. The end of the three-way connector away from the injection tube is detachably connected to the main cavity tube through a first connecting tube with a connecting connector. The remaining end of the three-way connector is also connected to a pressure detection device through a second connecting tube. The pressure detection device is electrically connected to a pressure control device, which is electrically connected to a power supply device. The pressure control device is also electrically connected to a pusher device capable of automatically pushing and pulling a push rod.
[0010] Furthermore, the connection joint is also connected to an overpressure protection device, which includes a pressure relief pipe connected to the connection joint. The end of the pressure relief pipe away from the connection joint is connected to a liquid reservoir, and a pressure relief valve is installed on the pressure relief pipe.
[0011] Furthermore, it also includes an open storage box, in which a partition is installed to divide the storage box into two open storage cavities. The injection device and the pushing device are installed in different storage cavities. The injection tube is parallel to the partition. The pushing device includes a lead screw parallel to the partition. The two ends of the lead screw are rotatably connected to the storage box, and one end of the lead screw is driven to a motor electrically connected to a pressure control device. The lead screw is also fitted with and threaded to a movable part. One end of the movable part passes through the partition and is slidably connected to the partition along its length. The end of a push rod located outside the injection tube is mounted on the movable part.
[0012] Furthermore, the cavity containing the liquid injection device is the first cavity, and the other cavity is the second cavity. The second cavity also contains a power supply device and a pressure control device. A fixed cover is installed at the opening of the second cavity. A control panel electrically connected to the pressure control device is embedded in the fixed cover. A display screen electrically connected to the control panel is embedded in the control panel. LED lights and various buttons are also installed on the control panel.
[0013] Furthermore, both the pressure detection device and the injection device are located inside the first storage cavity, and the pressure detection device is electrically connected to the pressure control device via a wire with a pluggable connector. The injection tube is detachably fixed inside the first storage cavity, and the push rod and the movable part are detachably fixedly connected. An openable flip cover is installed at the opening of the first storage cavity.
[0014] Furthermore, the method of using the above-mentioned controllable dilatation myofascitis release balloon catheter injection system includes the following steps: Step 1: Preoperative preparation S1 Instrument Preparation: Fill the injection tube with liquid medium and connect or link various medical devices; S2 imaging localization: Using an ultrasound probe to scan the target area and mark superficial or deep fascial adhesion points; S3 local anesthesia; Step 2: Balloon catheter insertion and dilation S1 puncture and catheterization: Before catheterization, the balloon is folded and inserted through the puncture needle or incision into the balloon catheter, so that the folded balloon reaches the target fascia layer. S2 Pressure Control: Connect the connector to the main lumen tube, turn on the pressure control device, and set the safe pressure threshold that the balloon can reach based on the tear threshold of the superficial or deep fascia. Then, start the pusher device, push the push rod to inject liquid medium into the balloon. At this time, after removing the sealing cap, the gas in the balloon catheter can be discharged through the side lumen tube until the liquid medium flows out of the side lumen tube. Then, reinstall the sealing cap and continue to inject liquid medium into the balloon to gradually increase the pressure inside the balloon. The pressure detection device can provide real-time feedback of pressure value data to the pressure control device, and automatically control the operation of the pusher device through the pressure control device until the pressure inside the balloon reaches the safe pressure threshold preset in the pressure control device. After the balloon is inflated, the pusher device stops operating and maintains stable pressure. S3 fasciolysis: balloon dilation is maintained for 5-10 minutes, and the width of the fascial space is monitored by ultrasound. Step 3: Withdraw the balloon catheter S1 depressurization and retraction: The pressure control device controls the push device to pull the push rod in the opposite direction, so as to discharge the liquid medium from the balloon, thereby depressurizing the balloon until the balloon retracts to its initial folded state. S2 Catheter Removal: Disconnect the connector, slowly withdraw the balloon catheter, and apply pressure bandage to the puncture site or incision site with gelatin sponge to prevent hematoma formation.
[0015] Furthermore, in step S2 pressure regulation, it is assumed that the safe pressure threshold that can be reached inside the balloon is set to A in the pressure control device, and it is assumed that the pressure detection device detects the pressure value inside the balloon in real time as B, both in kPa. When B is less than or equal to A-1, the pushing device pushes the push rod to continuously inject liquid medium into the balloon, so that the pressure inside the balloon is gradually increased until B is greater than A-1 and less than or equal to A+1. Then the pushing device stops operating and maintains the pressure stable. Based on this, during the procedure, when the balloon is compressed by human tissue and the pressure value inside changes, if B is directly greater than A+1, the pusher will pull the push rod in the opposite direction to expel the liquid medium from the balloon until B is greater than A-1 and less than or equal to A+1, at which point the pusher will stop operating. If B is directly greater than (1+15%)A, the pressure value B inside the balloon will exceed the set pressure for opening the pressure relief valve. The overpressure protection device will automatically release the pressure and cooperate with the pusher to pull the push rod in the opposite direction to expel the liquid medium from the balloon until B is greater than A-1 and less than or equal to A+1. In addition, after the liquid medium is expelled from the balloon, if the pressure from human tissue weakens or gradually disappears, the pusher can push the push rod to re-inject the liquid medium into the balloon, so that the pressure inside the balloon is always maintained between A-1 and A+1, thus maintaining pressure stability.
[0016] The beneficial effects of the present invention by adopting the above technical solution are as follows: Before use, this invention allows for ultrasound guidance to scan the target area, mark superficial or deep fascial adhesions, and identify interfascial spaces for precise release. The balloon can be folded to its minimum diameter by compression, facilitating subsequent insertion of the balloon catheter into the patient. During use, the balloon catheter is inserted through a needle or incision, bringing the folded balloon to the target fascial layer. Liquid is then injected into the balloon via the main lumen and inner tube using a syringe or other injection tool. After removing the sealing cap, gas inside the balloon catheter is expelled through the side lumen until the liquid is released from the side lumen. After the fluid drains out, the sealing cap is replaced, and liquid medium is injected into the balloon to gradually increase pressure and expand it. This effectively separates and loosens the adhesions in the fascia. In addition, during the injection of liquid medium into the balloon, a mesh tubular support structure guides the distribution of force, allowing the balloon to fully expand along its axial direction first. This reduces the possibility of insufficient lateral fascial release. At the same time, the mesh tubular support structure also limits excessive radial expansion of the balloon, controlling the direction of balloon expansion and preventing excessive fascial stretching. This reduces the possibility of excessive fascial release and ensures the therapeutic effect. Attached Figure Description
[0017] Figure 1 This is one of the structural schematic diagrams of the present invention; Figure 2 This is the second structural schematic diagram of the present invention; Figure 3 This is the third structural schematic diagram of the present invention; Figure 4 This is a schematic diagram of the structure of some of the devices of the present invention; Figure 5 for Figure 4 A cross-sectional view of the middle part of the device; Figure 6 for Figure 4 A schematic diagram of the structure of the middle part of the device; Figure 7 This is a schematic diagram of the structure of the balloon of the present invention; Figure 8 This is a flowchart illustrating the operation of part of the present invention; Figure 9 This is a coordinate axis diagram of the liquid injection system of the present invention when it performs its operation.
[0018] Reference numerals: 1. Power supply device; 2. Pushing device; 21. Lead screw; 22. Motor; 23. Moving part; 3. Pressure detection device; 31. Pluggable connector; 4. Storage box; 41. Partition; 42. First storage cavity; 43. Second storage cavity; 44. Fixed cover; 45. Flip cover; 46. Handle; 5. Overpressure protection device; 51. Pressure relief pipe; 52. Liquid reservoir; 53. Pressure relief valve; 6. Pressure control device; 61. Microcontroller; 62. Pressure sensing and control module; 63. Motor control module; 64. Control panel; 65. Display screen; 7. Catheter; 71. Inner tube; 72. Outer tube; 73. Through hole; 8. Injection device; 81. Injection tube; 82. Push rod; 83. T-connector; 84. Connecting connector; 85. First connecting tube; 9. Y-connector; 91. Main lumen tube; 92. Side lumen tube; 10. Balloon; 101. Mesh tubular support structure; 102. Balloon body; 103. Anti-adhesion coating; 11. Sealing cap; 12. Imaging marker ring; 13. Occlusion cap; 14. Second connecting tube. Detailed Implementation
[0019] To make the objectives, technical solutions, and beneficial effects of the present invention clearer, the embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.
[0020] like Figures 1 to 7 As shown, the present invention provides a controllable dilatation myofascitis release balloon catheter, including a catheter 7 having a head end and a tail end. A balloon 10 is fitted onto the head end of the catheter 7, and a Y-type connector 9 is installed at the tail end of the catheter 7. The Y-type connector 9 includes a main lumen 91 with openings at both ends and a side lumen 92 installed on the main lumen 91. The side lumen 92 is a tubular structure with openings at both ends. A sealing cap 11 is detachably installed at the end of the side lumen 92 away from the main lumen 91. Specifically, the sealing cap 11 is fitted onto the side lumen 92 and threadedly connected to the side lumen 92, which facilitates the installation and removal of the sealing cap 11 on the Y-type connector 9.
[0021] Furthermore, the catheter 7 includes an inner tube 71 and an outer tube 72 arranged coaxially. One end of the inner tube 71 extends outside the outer tube 72, and the other end of the inner tube 71 is sealed and fixedly connected to the outer tube 72, both located within the main lumen 91. That is, the end of the outer tube 72 located within the main lumen 91 is closed. The inner tube 71 is connected to the main lumen 91, and the side lumen 92 is connected to the outer tube 72. The balloon 10 is located at the extended end of the inner tube 71. The balloon 10 includes a mesh tubular support structure 101 coaxially sleeved on the inner tube 71 and made of woven fibers. Specifically, the mesh tubular support structure 101 is made of polyester fiber material or nylon fiber. The material is woven at a 45-degree angle; a balloon body 102 made of silicone material with two open ends is fixedly covered on the mesh tubular support structure 101, or the mesh tubular support structure 101 can be embedded in the balloon body 102; the wall thickness of the balloon body 102 can be set to 0.1mm; one end of the balloon body 102 is fixedly connected to the end of the outer tube 72 away from the Y-shaped connector 9, and the other end of the balloon body 102 is sealed and fixedly connected to the extension end of the inner tube 71, and a through hole 73 is opened on the inner tube 71 located inside the balloon body 102, that is, the inner tube 71 is connected to the inside of the balloon body 102.
[0022] Specifically, before use, the present invention can be used with ultrasound guidance to scan the target area, mark superficial or deep fascial adhesion points, and identify the gaps between fascia to achieve precise release. Furthermore, by squeezing the balloon 10, it can be folded to its minimum diameter to facilitate subsequent insertion of the balloon catheter into the patient's body. During use, the balloon catheter can be inserted through a puncture needle or incision, allowing the folded balloon 10 to reach the target fascial layer. Then, using an injection tool such as a syringe, liquid medium can be injected into the balloon 10 through the main lumen 91 and inner tube 71. At this point, after removing the sealing cap 11, the gas inside the balloon catheter can be expelled through the side lumen 92 until the liquid medium flows out from the side lumen 92. Afterward, the sealing cap 11 is reattached, and liquid medium is continued to be injected into the balloon 10 to gradually increase pressure and expand it, thereby effectively separating and releasing the fascia. In addition to releasing adhesions to the fascia, during the injection of liquid medium into the balloon 10, the mesh tubular support structure 101 guides the distribution of force, allowing the balloon 10 to fully expand along its axial direction first. This reduces insufficient lateral fascial release. At the same time, the mesh tubular support structure 101 also limits excessive radial expansion of the balloon 10, controlling the expansion direction of the balloon 10 and preventing excessive fascial stretching, thereby reducing excessive fascial release and ensuring treatment effectiveness. Then, after the balloon 10 is expanded and maintained for 5-10 minutes, the width of the fascial gap is monitored by ultrasound. For example, when the width of the fascial gap is greater than or equal to the target width of 3mm, the liquid medium is expelled from the balloon 10 using a syringe or other injection tool to depressurize the balloon 10 until it retracts to its initial folded state, at which point the balloon catheter is withdrawn.
[0023] Furthermore, such as Figure 4 and Figure 6 As shown, two spaced-apart contrast-enhancing rings 12 are fitted onto the inner tube 71 inside the balloon 10, with the two contrast-enhancing rings 12 located at opposite ends of the balloon 10. Specifically, the contrast-enhancing rings 12 are barium rings, with a width that can be set to 1 mm, and the distance between the two barium rings can be set to 5 cm, adaptable to ultrasound or X-ray imaging. Furthermore, the reflected signal is strongest when the barium rings are at a 45° angle to the ultrasound probe. By setting two contrast-enhancing rings 12, the position of the balloon 10 can be monitored and observed in real time during the operation, facilitating intraoperative positioning and adjustment and avoiding the risk of blind puncture. In addition, after the liquid medium is injected into the balloon 10, it can be displayed as a high-echo ring structure under ultrasound, which can be contrasted with the surrounding low-echo fascia during the operation, meaning that the balloon 10 itself has contrast-enhancing function.
[0024] Furthermore, such as Figures 1 to 4 and Figure 6As shown, the extension end of the inner tube 71 is sealed and fixedly connected to the end of the balloon body 102 by a sealing cap 13 with imaging function. Specifically, the sealing cap 13 has imaging function under ultrasound, which makes it easier to locate the position of the tip of the catheter 7 during the operation.
[0025] Furthermore, such as Figure 7 As shown, the outer surface of the balloon body 102 is coated with an anti-adhesion coating 103. Specifically, the anti-adhesion coating 103 is a hyaluronic acid anti-adhesion coating with a thickness of 10 μm. By setting the anti-adhesion coating 103, it is easier to insert the balloon catheter into the patient's body.
[0026] Furthermore, such as Figures 1 to 3 As shown, the above-mentioned controllable dilatation myofascial release balloon catheter injection system includes an injection device 8, which includes an injection tube 81 connected to the main lumen tube 91. A plunger 82 with a piston is slidably connected inside the injection tube 81. Specifically, the injection tube 81 has the same structure as a syringe needle in the prior art. The injection tube 81 can be used to hold liquid media such as contrast agents or saline. In use, after inserting the balloon catheter into the patient's body and positioning the folded balloon 10 to the target fascial layer, then... The injection tube 81 is connected to the main lumen tube 91 to facilitate the insertion of the balloon catheter into the patient's body. Then, by pushing the push rod 82, liquid medium is injected into the balloon 10 through the main lumen tube 91 and the inner tube 71 to gradually increase the pressure inside the balloon 10 for expansion. Before withdrawing the balloon catheter, the liquid medium can be expelled from the balloon 10 by pulling the push rod 82 to depressurize the balloon 10 until it retracts to its initial folded state. Then, the injection tube 81 is removed to facilitate the withdrawal of the balloon catheter.
[0027] Furthermore, such as Figures 1 to 3 As shown, the liquid outlet of the injection tube 81 is connected to a three-way connector 83. The end of the three-way connector 83 away from the injection tube 81 is detachably connected to the main lumen tube 91 through a first connecting tube 85 with a connecting connector 84, that is, the connecting connector 84 and the main lumen tube 91 are detachably connected. The remaining end of the three-way connector 83 is also connected to a pressure detection device 3 through a second connecting tube 14. The pressure detection device 3 is a capacitive pressure sensor with a measurement range of 0-30 kPa and an accuracy of ±0.5 kPa. In use, the built-in chip of the sensor is directly connected to the liquid medium inside the balloon 10, and can detect the pressure value inside the balloon 10 in real time. The pressure detection device 3 is electrically connected to a pressure control device 6, which includes a microcontroller 61 and a pressure sensing control module 62. The pressure control device 6 is electrically connected to a power supply device 1, and the pressure control device 6 is also electrically connected to a pusher device 2 that can automatically push and pull the push rod 82.
[0028] Specifically, before use, a safe pressure threshold that the balloon 10 can reach can be preset in the pressure control device 6 according to the tear threshold of the superficial or deep fascia. For example, if the tear threshold of the ex vivo fascia is 20-30 kPa, the safe pressure threshold can be set to 50% of the tear threshold. When specifically separating superficial or deep fascial adhesions, i.e., for different treatment areas, the corresponding safe pressure threshold can be adjusted according to the different tear thresholds of the superficial or deep fascia to ensure that the expansion force inside the balloon 10 is within a safe range and can be controlled for expansion. During use, when the pushing device 2 is activated, the push rod 82 can be automatically pushed to inject liquid medium into the balloon 10, and the pressure detection device 3 can detect the balloon 10 in real time. The pressure value inside the balloon 10 is measured and transmitted in real time to the pressure control device 6. The pressure value signal is then fed back to the pressure control device 6 until the pressure value inside the balloon 10 reaches the safety pressure threshold preset in the pressure control device 6. After the balloon 10 is expanded, the pressure control device 6 controls the pushing device 2 to stop working and maintain pressure stability to prevent excessive expansion pressure inside the balloon 10. In other words, the present invention can control the pressure inside the balloon 10 in a closed loop according to the different expansion pressures required for deep fascia and superficial fascia release to prevent over-release. Then, when it is necessary to withdraw the balloon catheter, the pressure control device 6 controls the pushing device 2 to pull the push rod 82 in the opposite direction, which can discharge the liquid medium outside the balloon 10 to depressurize the balloon 10 until the balloon 10 retracts to its initial folded state.
[0029] Furthermore, it is possible to... Figure 9 As shown, assuming that the safe pressure threshold that can be reached inside the balloon 10 is set to A in the pressure control device 6, and assuming that the pressure detection device 3 detects the pressure value inside the balloon 10 in real time as B, both in kPa, when B is less than or equal to A-1, the pushing device 2 pushes the push rod 82 to continuously inject liquid medium into the balloon 10, so that the pressure inside the balloon 10 is gradually increased until B is greater than A-1 and less than or equal to A+1, the pushing device 2 stops working and maintains the pressure stable. That is, the present invention can control the pressure fluctuation range inside the balloon 10 within ±1 kPa.
[0030] Based on this, when the pushing device 2 stops operating, if the pressure value inside the balloon 10 changes during the operation due to pressure from human tissue, and if B is directly greater than A+1, the pushing device 2 pulls the push rod 82 in the opposite direction to discharge the liquid medium from the balloon 10 until B is greater than A-1 and less than or equal to A+1, then the pushing device 2 stops operating. In addition, after the liquid medium is discharged from the balloon 10, if the pressure from human tissue weakens or gradually disappears, the pushing device 2 can push the push rod 82 to re-inject the liquid medium into the balloon 10, so that the pressure inside the balloon 10 is always maintained between A-1 and A+1, thus maintaining pressure stability.
[0031] Furthermore, such as Figures 1 to 3 As shown, the connecting joint 84 is also connected to an overpressure protection device 5. The overpressure protection device 5 includes a pressure relief pipe 51 connected to the connecting joint 84. The end of the pressure relief pipe 51 away from the connecting joint 84 is connected to a reservoir 52, and a pressure relief valve 53 is installed on the pressure relief pipe 51. The pressure relief valve 53 is a spring-loaded pressure relief valve. During use, when the pressure inside the balloon 10 reaches the set pressure for opening the pressure relief valve 53, the pressure relief valve 53 can automatically open to avoid instantaneous high pressure damage to human tissue; and when the pressure inside the balloon 10 gradually decreases, the pressure relief valve 53 can also automatically close. The overpressure protection device 5 can be used for emergency pressure relief inside the balloon 10. Specifically, during the operation, when the balloon 10 is compressed by human tissue and its internal pressure changes, if B is directly greater than (1+15%)A, this... When the pressure B inside the balloon 10 exceeds the set pressure for opening the pressure relief valve 53, the overpressure protection device 5 will automatically release pressure and cooperate with the push device 2 to pull the push rod 82 in the opposite direction to discharge the liquid medium from the balloon 10 until B is greater than A-1 and less than or equal to A+1. At this time, after the liquid medium is discharged from the balloon 10, if the pressure of the human tissue weakens or gradually disappears, the push device 2 can push the push rod 82 to inject liquid medium back into the balloon 10, so that the pressure inside the balloon 10 is always kept between A-1 and A+1, maintaining pressure stability. That is to say, when the pressure inside the balloon 10 is within different ranges, the push device 2 and the overpressure protection device 5 can perform corresponding operations to dynamically control the expansion pressure inside the balloon 10 in real time.
[0032] Furthermore, such as Figures 1 to 3As shown, it also includes an open storage box 4, with a partition 41 inside the storage box 4 dividing it into two open storage chambers. The injection device 8 and the pushing device 2 are installed in different storage chambers. The injection tube 81 is parallel to the partition 41. The pushing device 2 includes a lead screw 21 parallel to the partition 41, with both ends of the lead screw 21 rotatably connected to the storage box 4. One end of the lead screw 21 is connected to a motor 22 electrically connected to the pressure control device 6. Specifically, the pressure control device 6 also includes a motor control module 63, and the motor 22 is a reversible motor. During use, the pressure control device 6, combined with a PID algorithm, can dynamically adjust the forward and reverse rotation and speed of the motor 22. The lead screw 21 also... A movable part 23 is fitted and threadedly connected to the partition 41. One end of the movable part 23 passes through the partition 41 and is slidably connected to the partition 41 along its length. Specifically, the movable part 23 is slidably connected to the partition 41 through a slide rail that is parallel to the partition 41. The end of the push rod 82 located outside the injection tube 81 is mounted on the movable part 23. Specifically, in use, the forward and reverse rotation of the motor 22 can drive the lead screw 21 to rotate. During the rotation of the lead screw 21, the movable part 23 can be moved along the length of the partition 41, thereby driving the push rod 82 to move inside the injection tube 81 to perform push-pull operations, that is, the push rod 82 moves forward and backward, which can realize the injection and discharge of liquid medium.
[0033] Furthermore, such as Figures 1 to 3 As shown, the cavity containing the injection device 8 is the first cavity 42, and the other cavity is the second cavity 43. The second cavity 43 also contains a power supply device 1 and a pressure control device 6. A fixed cover 44 is installed at the opening of the second cavity 43. A control panel 64, electrically connected to the pressure control device 6, is embedded in the fixed cover 44. A display screen 65, also electrically connected to the control panel 64, is embedded in the control panel 64. The display screen 65 can display the pressure value inside the balloon 10 in real time, facilitating real-time monitoring of the pressure inside the balloon 10. Furthermore, an LED is also installed on the control panel 64. The device includes a D-shaped indicator light and various buttons, such as the pressure release button, stop button, power-on button, setting button, and injection button. Specifically, pressing the power-on button turns on the pressure control device 6; pressing the setting button allows setting the safe pressure threshold that the balloon 10 can reach in the pressure control device 6; pressing the injection button activates the pusher device 2 to push the push rod 82; pressing the pressure release button activates the pusher device 2 to pull the push rod 82 in the opposite direction; and pressing the stop button for a long time also activates the pusher device 2 to pull the push rod 82 in the opposite direction, but this quickly empties the liquid medium from the balloon 10.
[0034] Furthermore, such as Figures 1 to 3As shown, the pressure detection device 3 and the injection device 8 are both located in the first storage cavity 42. The pressure detection device 3 is electrically connected to the pressure control device 6 via a wire with a pluggable connector 31. That is, the pressure detection device 3 can be removed after the pluggable connector 31 is unplugged. The injection tube 81 is detachably fixed in the first storage cavity 42. The push rod 82 and the movable part 23 are detachably fixedly connected. Specifically, the injection tube 81 is placed in the housing slot opened in the first storage cavity 42. The end of the push rod 82 outside the injection tube 81 is placed in the slot opened on the movable part 23, that is, the injection device 8 is detachable. In other words, the pressure detection device 3, the injection device 8, the second connecting tube 14, the balloon catheter and the overpressure protection device 5 are all replaceable parts, for single use only, which complies with the medical consumables management regulations.
[0035] In addition, a hinged cover 45 is installed at the opening of the first storage cavity 42. Specifically, one side of the cover 45 is hinged to the storage box 4, and a handle 46 is provided on the outer surface of the cover 45 to facilitate opening and closing the cover 45.
[0036] Furthermore, the method of using the above-mentioned controllable dilatation myofascitis release balloon catheter injection system includes the following steps: Step 1: Preoperative preparation S1 Instrument Preparation: Fill the injection tube 81 with liquid medium and connect or link various medical devices. S2 imaging localization: Using an ultrasound probe to scan the target area and mark superficial or deep fascial adhesion points; S3 local anesthesia: The puncture site can be infiltrated with 1% lidocaine; Step 2: Balloon catheter insertion and dilation S1 puncture and catheter placement: Before catheter placement, the balloon 10 is folded and inserted into the balloon catheter through the puncture needle or incision, so that the folded balloon 10 reaches the target fascia layer. S2 Pressure Regulation: Connect connector 84 to main cavity tube 91, then... Figure 8As shown, when the pressure control device 6 is turned on, a safe pressure threshold that can be reached inside the balloon 10 is set in the pressure control device 6 according to the tear threshold of the superficial or deep fascia. Then, the pushing device 2 is activated, pushing the push rod 82 to inject liquid medium into the balloon 10. At this time, after removing the sealing cap 11, the gas in the balloon catheter can be discharged through the side lumen tube 92 until the liquid medium flows out from the side lumen tube 92. Then, the sealing cap 11 is reinstalled, and liquid medium is injected into the balloon 10 to gradually increase the pressure inside the balloon 10. The pressure detection device 3 can feed back the pressure value data to the pressure control device 6 in real time, and automatically control the operation of the pushing device 2 through the pressure control device 6 until the pressure inside the balloon 10 reaches the safe pressure threshold set in the pressure control device 6. After the balloon 10 is expanded, the pushing device 2 stops operating and maintains stable pressure. S3 fasciolysis: balloon dilation with 10 was maintained for 5-10 minutes, and the width of the fascial space was monitored by ultrasound. Step 3: Withdraw the balloon catheter S1 Pressure relief and retraction: The pressure control device 6 controls the push device 2 to pull the push rod 82 in the opposite direction to discharge the liquid medium from the balloon 10, so as to relieve the pressure of the balloon 10 until the balloon 10 retracts to the initial folded state. S2 Catheter Removal 7: Remove the connector 84, slowly withdraw the balloon catheter, and apply pressure bandage to the puncture site or incision site with gelatin sponge to prevent hematoma formation.
[0037] Furthermore, in step S2 pressure regulation, it is assumed that the safe pressure threshold that the balloon 10 can reach is set to A in the pressure control device 6, and it is assumed that the pressure detection device 3 detects the pressure value inside the balloon 10 in real time as B, both in kPa. When B is less than or equal to A-1, the pushing device 2 pushes the push rod 82 to continuously inject liquid medium into the balloon 10, so that the pressure inside the balloon 10 is gradually increased until B is greater than A-1 and less than or equal to A+1. Then the pushing device 2 stops operating and maintains the pressure stable. Based on this, when the balloon 10 is compressed by human tissue and the pressure value inside changes, if B is directly greater than A+1, the pushing device 2 pulls the push rod 82 in the opposite direction to discharge the liquid medium from the balloon 10 until B is greater than A-1 and less than or equal to A+1, at which point the pushing device 2 stops operating; if B is directly greater than (1+15%)A, the pressure value B inside the balloon 10 will exceed the set pressure of the pressure relief valve 53, and the overpressure protection device 5 will automatically release pressure and cooperate with the pushing device 2 to pull the push rod 82 in the opposite direction to discharge the liquid medium from the balloon 10 until B is greater than A-1 and less than or equal to A+1; in addition, after the liquid medium is discharged from the balloon 10, if the pressure from the human tissue weakens or gradually disappears, the pushing device 2 can push the push rod 82 to inject liquid medium back into the balloon 10 so that the pressure inside the balloon 10 is always maintained between A-1 and A+1, thus maintaining pressure stability.
[0038] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claims. The scope of protection of this invention is defined by the appended claims and their equivalents.
Claims
1. A controllable dilatation myofascitising balloon catheter, comprising a catheter having a head end and a tail end, wherein a balloon is fitted onto the head end of the catheter, characterized in that: The catheter is fitted with a Y-type connector at its tail end. The Y-type connector includes a main lumen tube with openings at both ends and a side lumen tube installed on the main lumen tube. A sealing cap is detachably installed at the end of the side lumen tube away from the main lumen tube. The catheter includes an inner tube and an outer tube arranged coaxially. One end of the inner tube extends to the outside of the outer tube, and the other end of the inner tube is sealed and fixedly connected to the outer tube and both are located inside the main lumen tube. The inner tube is connected to the main lumen tube, and the side lumen tube is connected to the inside of the outer tube. The balloon is located at the extension end of the inner tube. The balloon includes a mesh-like tubular support structure coaxially sleeved on the inner tube and made of woven fibers. A balloon body made of silicone material with openings at both ends is fixedly covered on the mesh-like tubular support structure. One end of the balloon body is fixedly connected to the end of the outer tube away from the Y-shaped connector, and the other end of the balloon body is sealed and fixedly connected to the extension end of the inner tube. A through hole is opened on the inner tube located inside the balloon body.
2. The controllable dilatation myofascitis release balloon catheter according to claim 1, characterized in that: Two spaced-apart radiopaque rings are fitted onto the inner tube inside the balloon.
3. A fluid injection system for a controllable dilatation myofascitising balloon catheter as described in claim 1, characterized in that: The device includes an injection device, which includes an injection tube connected to the main cavity tube, and a push rod with a piston is slidably connected inside the injection tube.
4. The fluid injection system of the controllable dilatation myofascitis release balloon catheter according to claim 3, characterized in that: The liquid outlet end of the injection tube is connected to a three-way connector. The end of the three-way connector away from the injection tube is detachably connected to the main cavity tube through a first connecting tube with a connecting connector. The remaining end of the three-way connector is also connected to a pressure detection device through a second connecting tube. The pressure detection device is electrically connected to a pressure control device, which is electrically connected to a power supply device. The pressure control device is also electrically connected to a pusher device that can automatically push and pull the push rod.
5. The fluid injection system of the controllable dilatation fascia release balloon catheter according to claim 4, characterized in that: The connection joint is also connected to an overpressure protection device, which includes a pressure relief pipe connected to the connection joint. The end of the pressure relief pipe away from the connection joint is connected to a liquid reservoir, and a pressure relief valve is installed on the pressure relief pipe.
6. The fluid injection system for a controllable dilatation myofascitis release balloon catheter according to claim 4, characterized in that: It also includes an open storage box, in which a partition divides the storage box into two open storage cavities. The injection device and the pusher are installed in different storage cavities. The injection tube is parallel to the partition. The pusher includes a lead screw parallel to the partition. Both ends of the lead screw are rotatably connected to the storage box, and one end of the lead screw is driven by a motor electrically connected to a pressure control device. The lead screw is also fitted with and threaded to a movable part. One end of the movable part passes through the partition and is slidably connected to the partition along its length. The end of a pusher located outside the injection tube is mounted on the movable part.
7. The fluid injection system for a controllable dilatation myofascitis release balloon catheter according to claim 6, characterized in that: The first storage chamber contains the liquid injection device, and the second storage chamber contains a power supply device and a pressure control device. The opening of the second storage chamber is fitted with a fixed cover, on which a control panel electrically connected to the pressure control device is embedded. The control panel is fitted with a display screen electrically connected to the control panel, and LED lights and various buttons are also installed on the control panel.
8. The fluid injection system for a controllable dilatation myofascitis release balloon catheter according to claim 7, characterized in that: The pressure detection device and the injection device are both located in the first storage cavity. The pressure detection device is electrically connected to the pressure control device via a wire with a pluggable connector. The injection tube is detachably fixed in the first storage cavity. The push rod and the movable part are detachably fixedly connected. An openable flip cover is installed at the opening of the first storage cavity.
9. A method of using the fluid injection system of the controllable dilatation myofascitis release balloon catheter as described in claim 5, characterized in that: Includes the following steps: Step 1: Preoperative preparation S1 Instrument Preparation: Fill the injection tube with liquid medium and connect or link various medical devices; S2 imaging localization: Using an ultrasound probe to scan the target area and mark superficial or deep fascial adhesion points; S3 local anesthesia; Step 2: Balloon catheter insertion and dilation S1 puncture and catheterization: Before catheterization, the balloon is folded and inserted through the puncture needle or incision into the balloon catheter, so that the folded balloon reaches the target fascia layer. S2 Pressure Control: Connect the connector to the main lumen tube, turn on the pressure control device, and set the safe pressure threshold that the balloon can reach based on the tear threshold of the superficial or deep fascia. Then, start the pusher device, push the push rod to inject liquid medium into the balloon. At this time, after removing the sealing cap, the gas in the balloon catheter can be discharged through the side lumen tube until the liquid medium flows out of the side lumen tube. Then, reinstall the sealing cap and continue to inject liquid medium into the balloon to gradually increase the pressure inside the balloon. The pressure detection device can provide real-time feedback of pressure value data to the pressure control device, and automatically control the operation of the pusher device through the pressure control device until the pressure inside the balloon reaches the safe pressure threshold preset in the pressure control device. After the balloon is inflated, the pusher device stops operating and maintains stable pressure. S3 fasciolysis: balloon dilation is maintained for 5-10 minutes, and the width of the fascial space is monitored by ultrasound. Step 3: Withdraw the balloon catheter S1 depressurization and retraction: The pressure control device controls the push device to pull the push rod in the opposite direction, so as to discharge the liquid medium from the balloon, thereby depressurizing the balloon until the balloon retracts to its initial folded state. S2 Catheter Removal: Disconnect the connector, slowly withdraw the balloon catheter, and apply pressure bandage to the puncture site or incision site with gelatin sponge to prevent hematoma formation.
10. The method of using the fluid injection system of the controllable dilatation myofascitis release balloon catheter according to claim 9, characterized in that: In step S2 pressure regulation, it is assumed that the safe pressure threshold that can be reached inside the balloon is set to A in the pressure control device, and it is assumed that the pressure detection device detects the pressure value inside the balloon in real time as B, both in kPa. When B is less than or equal to A-1, the pushing device pushes the push rod to continuously inject liquid medium into the balloon, so that the pressure inside the balloon is gradually increased until B is greater than A-1 and less than or equal to A+1. Then the pushing device stops working and maintains the pressure stable. Based on this, during the procedure, when the balloon is compressed by human tissue and the pressure value inside changes, if B is directly greater than A+1, the pusher will pull the push rod in the opposite direction to expel the liquid medium from the balloon until B is greater than A-1 and less than or equal to A+1, at which point the pusher will stop operating. If B is directly greater than (1+15%)A, the pressure value B inside the balloon will exceed the set pressure for opening the pressure relief valve. The overpressure protection device will automatically release the pressure and cooperate with the pusher to pull the push rod in the opposite direction to expel the liquid medium from the balloon until B is greater than A-1 and less than or equal to A+1. In addition, after the liquid medium is expelled from the balloon, if the pressure from human tissue weakens or gradually disappears, the pusher can push the push rod to re-inject the liquid medium into the balloon, so that the pressure inside the balloon is always maintained between A-1 and A+1, thus maintaining pressure stability.