Periosteal distraction device

Abstract

The application discloses a periosteal distraction device, comprising a plurality of liquid-filled capsule parts, each of the liquid-filled capsule parts is arranged in a row by being connected in series, and a balloon string is formed. The liquid-filled capsule part comprises a main channel and a balloon in communication with the main channel. The main channel in any one of the liquid-filled capsule parts is provided with a liquid passage. The main channels in adjacent liquid-filled capsule parts are connected through a control valve. The balloon is configured to expand in the same direction after being filled with liquid. The balloon string is arranged to make all the balloons in the periosteal distraction device shrink during implantation, so that the periosteal distraction device is easy to implant, and the surgical trauma is small. The balloons in each liquid-filled capsule part can be expanded in sequence through the control valve, so that the daily distraction step is accurately controlled.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a periosteal traction device. Background Technology

[0002] Diabetic foot is a serious complication of diabetes, caused by long-term abnormal blood sugar levels damaging blood vessels and nerves in the lower limbs. Patients experience decreased sensation and poor blood circulation in their feet, making them prone to ulceration and infection from even minor injuries. Numbness, ulceration, and gangrene may also occur.

[0003] For the treatment of diabetic foot, periosteal distraction technique can be used. The core of this technique is to apply slow, continuous, stable, and uniform axial distraction stress to living tissue. This activates the tissue's regenerative potential, stimulates cell proliferation and the expression of pro-angiogenic factors such as growth factors, and induces widespread capillary angiogenesis and collateral circulation in the distraction area. Periosteal distraction is mainly achieved through periosteal distraction devices, currently the mainstream types being distraction plates and balloons.

[0004] However, distraction plate-type periosteal distraction devices have the drawback of significant surgical trauma. While balloon-type periosteal distraction devices have less surgical trauma, the expansion of the balloon is difficult to control, making it difficult to precisely achieve the same daily distraction step length as distraction plate-type devices. Summary of the Invention

[0005] To address the problems existing in the prior art, this invention discloses a periosteal traction device that allows for precise control of the daily traction step length while minimizing implantation trauma.

[0006] The objective of this invention is achieved through the following technical solution:

[0007] A periosteal traction device includes a plurality of fluid-filled sacs, which are connected in series in a row to form a balloon string. Each fluid-filled sac includes a main channel and a balloon communicating with the main channel. Each main channel in any one of the fluid-filled sacs has a fluid inlet. The main channels in adjacent fluid-filled sacs are connected by a control valve. The balloons are configured such that each balloon expands in the same direction after being inflated with fluid.

[0008] Furthermore, it also includes several drug supply sub-tubes for containing the liquid medicine. Each of the filling bladders is equipped with a corresponding drug supply sub-tube. The drug supply sub-tubes are located close to the balloon, and the outer wall of the drug supply sub-tube has a bevel extending into the interior of the drug supply sub-tube. The drug supply sub-tubes are configured such that when the balloon inflates, the corresponding drug supply sub-tube is deformed by the balloon. The compression point of the drug supply sub-tube by the balloon is located away from the bevel, and the bevel is located within the deformation area of ​​the drug supply sub-tube under compression. The bevel opens to form an opening that facilitates the outflow of the liquid medicine. When the balloon contracts, the corresponding drug supply sub-tube is released from compression deformation and returns to its natural state. The opening closes, and the bevel prevents the liquid medicine from flowing out.

[0009] Furthermore, in a single inflatable bladder portion, the inflatable bladder portion includes a first balloon disposed on the first side of the main channel and a second balloon disposed on the second side of the main channel, and the drug delivery sub-tube is disposed between the first balloon and the second balloon; the drug delivery sub-tube is configured to be clamped by the inflated first balloon and the second balloon.

[0010] Furthermore, the control valve is a capillary valve.

[0011] Furthermore, each of the capillary valves is configured such that the opening pressure of the capillary valve increases as it moves away from the liquid inlet.

[0012] Furthermore, the drug supply sub-tubes corresponding to adjacent filling bladders are connected to each other to form a drug supply tube. A deformation buffer tube is connected between two adjacent drug supply sub-tubes. The deformation buffer tube is configured to prevent the drug supply sub-tube in the natural state from being deformed by the adjacent drug supply sub-tube in the deformed state.

[0013] Furthermore, the drug supply tube is connected to the main channel via a connector, and the oblique cut is located away from the connector.

[0014] Furthermore, the fluid inlet is located on the main channel in the fluid-filled bladder at one end of the balloon string.

[0015] Furthermore, a valve body is connected between the main channel and the balloon; the valve body is configured to open the channel from the main channel to the balloon; when the pressure difference between the balloon and the main channel is lower than the pressure setting value of the valve body, the channel from the balloon to the main channel is closed; when the pressure difference between the balloon and the main channel is greater than or equal to the pressure setting value of the valve body, the channel from the balloon to the main channel is opened.

[0016] Furthermore, it also includes a shape memory alloy sheet, which includes a base plate and side plates disposed on opposite sides of the base plate; the shape memory alloy sheet is configured such that, when the shape memory alloy sheet is in the martensitic phase, the side plates on opposite sides of the base plate are close to each other, and the shape memory alloy sheet is tubular and wraps around the balloon string and the drug delivery tube; during the transformation of the shape memory alloy sheet from the martensitic phase to the austenitic phase, the side plates on opposite sides of the base plate move away from each other; when the shape memory alloy sheet is in the austenitic phase, the shape memory alloy sheet is flat.

[0017] Furthermore, it also includes an actuator, which includes a sheath tube, a connecting rod disposed within the sheath tube, and the shape memory alloy sheet, the balloon string, and the drug delivery tube forming a tension module; the tension module is configured to be connected to the connecting rod, and when the shape memory alloy sheet is in the martensitic phase, moving the connecting rod allows the tension module to enter the sheath tube or extend outside the sheath tube.

[0018] Compared with existing technologies, the advantages of this invention are as follows: By using a series of balloons, all balloons in the periosteal traction device are in a contracted state during implantation, facilitating implantation and minimizing surgical trauma. Furthermore, the control valves allow for sequential inflation of the balloons in each inflatable sac, enabling precise control of the daily traction step length. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the connection between the filling bladders of the present invention; Figure 2 This is a three-dimensional schematic diagram of the balloon string of the present invention, in which all balloons are inflated; Figure 3 This is a three-dimensional schematic diagram of the inflation of a portion of the balloons in the balloon string of the present invention; Figure 4 This is a schematic diagram of the sequential inflation of the balloon of the present invention; Figure 5 This is a schematic diagram of the second method of squeezing the drug delivery tube in this invention; Figure 6 yes Figure 2 Enlarged diagram of section A in the middle; Figure 7 This is a schematic diagram of the radial cross-section of the shape memory alloy sheet and the string of balloons of the present invention; Figure 8 This is a schematic diagram of the shape memory alloy sheet of the present invention transforming from the martensitic phase to the austenitic phase; Figure 9 This is a schematic diagram of the driver and tension module of the present invention; Figure 10This is a schematic diagram of the periosteal traction device of the present invention in use.

[0020] In the picture: 1 – Main channel; 2 – Balloon; 2a – First balloon; 2b – Second balloon; 2c – Contracted state; 2d – Inflated state; 3 – Fluid inlet; 4 – Drug solution; 5 – Capillary valve; 6 – Drug delivery tube; 7 – Connector; 8 – Valve body; 9 – Shape memory alloy sheet; 9a – Base plate; 9b – Side plate; 10 – Sheath tube; 11 – Connecting rod; 12 – Tension module; 13 – Periosteum; 14 – Bone; 15 – Vibrator; 16 – Strap; 17 – Thigh. Detailed Implementation

[0021] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] In the description of this invention, it should be noted that the terms "inner" and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0023] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the term "connection" should be interpreted broadly. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, the technical features involved in the different embodiments of this invention described below can be combined with each other as long as they do not conflict with each other.

[0024] like Figures 1 to 3As shown, this invention discloses a periosteal traction device, comprising several fluid-filled sacs arranged in series to form a balloon string. Specifically, each fluid-filled sac includes a main channel 1 and a balloon 2 communicating with the main channel 1. Adjacent fluid-filled sacs are connected to the main channel 1 via control valves. Preferably, two balloons 2 are provided, respectively located on opposite sides of the main channel 1. The balloon string as a whole resembles a centipede, with the main channel 1 representing the centipede's body and the balloons 2 representing its legs. In this invention, any one of the fluid-filled sacs has a fluid inlet 3 on its main channel 1. That is, the fluid inlet 3 can be located on the main channel 1 of a fluid-filled sac at one end of the balloon string, or on the main channel 1 of a fluid-filled sac in the middle of the balloon string.

[0025] Meanwhile, the main channel 1 is designed as a pipe, and will not expand when liquid is introduced into it. The main channel 1 has a certain strength and rigidity, facilitating its insertion into the human body. The balloons 2 are in a contracted state when empty of liquid, and will expand when filled with liquid. Furthermore, the balloons 2 are configured such that each balloon expands in the same direction after being filled with liquid; that is, after the balloon string is implanted into the human body, each balloon 2 can expand towards the periosteum 13 after being filled with liquid.

[0026] like Figures 1 to 4 As shown, the method of using the periosteal traction device of the present invention is as follows, taking the example of the fluid inlet 3 being located on the main channel 1 in the fluid-filled bladder at one end of the balloon string: Step 1: Make a minimally invasive incision to facilitate the entry of the periosteal traction device into the area to be tractioned.

[0027] Step 2: Ensure all balloons 2 are in a contracted state 2c, and connect the inlet 3 to the external fluid supply line. The external fluid supply line of the balloons can supply physiological saline to the inlet 3.

[0028] Step 3: Drive the balloon string from the micro-incision to the lesion site. The end of the balloon string away from the fluid inlet 3 passes through the micro-incision first, until the entire balloon string reaches the area to be stretched. At this time, the balloon string is located between the periosteum 13 and the bone 14.

[0029] Step 4: Define the fluid-filled bladder with the inlet 3 as the first fluid-filled bladder, the fluid-filled bladder adjacent to the one with the inlet 3 as the second fluid-filled bladder, and so on. The fluid-filled bladders moving away from the first fluid-filled bladder are sequentially designated as the third, fourth, ..., Nth fluid-filled bladder. The control valve between the first and second fluid-filled bladders is closed, and other control valves are also closed. Then, physiological saline is injected into the inlet 3, causing the balloon 2 in the fluid-filled bladder with the inlet 3 to inflate. The balloon 2 remains inflated for 2 days. Specifically, the balloon 2 inflates towards the periosteum 13, and even if the balloon 2 ruptures, the saline flowing into the body will not cause harm. The periosteum 13 is pushed away from the periosteum by the inflated balloon 2, i.e., the periosteum 13 is stretched. Due to the stretching of the periosteum 13, the periosteum 13 is stimulated, which induces cell proliferation and widespread capillary angiogenesis and the establishment of collateral circulation in the stretching area. However, due to the control valve, no saline solution flows into the balloon 2 within the second fluid-filled sac; the balloon 2 remains in a contracted state 2c.

[0030] Step 5: After a period of time (which could be one day), open the control valve between the first and second fluid-filled sacs, while keeping the other control valves closed. This allows saline solution to flow from the main channel 1 in the first fluid-filled sac into the main channel 1 in the second fluid-filled sac, and then into the balloon 2 within the second fluid-filled sac, causing the balloon 2 to inflate and remain in an inflated state for 2 days. The periosteum 13 is stretched by the expansion force of the balloon 2 in the second fluid-filled sac. Similarly, at regular intervals, open the corresponding control valves one by one in the direction away from the inlet 3, causing the balloons 2 in each fluid-filled sac to inflate sequentially. Each time a balloon 2 inflates, the periosteum 13 is stretched, allowing the periosteum 13 to be stretched periodically.

[0031] Step Six: After all balloons 2 have inflated, open all control valves and simultaneously drain fluid from the inlet 3. All saline solution in the main channels 1 and balloons 2 is drained, and each balloon 2 returns to a contracted state.

[0032] Step 7: Drive the balloon string through the micro-incision and leave the body.

[0033] This invention utilizes a series of cylindrical balloons, ensuring that all balloons 2 are in a contracted state 2c during implantation of the periosteal traction device. This results in a smaller overall size of the periosteal traction device, particularly in its shorter radial length, facilitating implantation and minimizing surgical trauma. Furthermore, the control valve allows for sequential inflation of each balloon 2 within its fluid-filled section, enabling precise control of the daily traction step length.

[0034] In the periosteal traction device of the present invention, many technical features, such as the structure of the control valve and the structure of other components in the periosteal traction device, have multiple implementations. Below, for each of the many technical features, including the structure of the control valve, one implementation is mainly selected for detailed description. The embodiment in which this implementation is located is referred to as this embodiment. Other implementations of the many features, including the structure of the control valve, are referred to as other embodiments, which are briefly described below.

[0035] In this embodiment, as Figure 1 As shown, the inlet 3 is located on the main channel 1 in the fluid-filled balloon portion at one end of the balloon string. Therefore, during balloon string implantation, as mentioned in step three above, the tubing responsible for connecting to the inlet 3 can be kept to a minimum size within the body, reducing the size of the micro-incision. In other embodiments, the inlet 3 can also be located on the main channel 1 in any other fluid-filled balloon portion.

[0036] In this embodiment, as Figure 1As shown, the control valve is capillary valve 5. A capillary valve is a passive, partless microfluidic valve that controls the start, stop, and flow direction of liquid in a microchannel by relying on surface tension and capillary pressure, without the need for external energy or mechanical drive. Specifically, the capillary valve between the first and second filling bladders is defined as the first capillary valve. Taking the first and second filling bladders as an example, physiological saline is injected into the first filling bladder through the inlet 3. The saline enters the bulb 2 in the first filling bladder, causing the bulb 2 to inflate. At this time, when the pressure of the saline in the main channel 1 of the first filling bladder on the first capillary valve is less than the critical opening pressure of the first capillary valve, the first capillary valve closes, and the saline cannot flow into the main channel 1 of the second filling bladder through the first capillary valve. Subsequently, after a period of time, physiological saline is continuously injected into the first filling bladder through the inlet 3, causing the pressure of the physiological saline in the first filling bladder against the first capillary valve to increase. When the pressure of the physiological saline in the first filling bladder against the first capillary valve is greater than or equal to the critical opening pressure of the first capillary valve, the first capillary valve opens, and physiological saline flows from the main channel 1 in the first filling bladder through the first capillary valve into the main channel 1 in the second filling bladder, thereby causing physiological saline to flow into the balloon 2 in the second filling bladder, causing the balloon 2 in the second filling bladder to inflate. Similarly, in the other capillary valves 5 besides the first capillary valve, the opening method is also by continuously injecting physiological saline through the inlet 3, causing the other capillary valves 5 to sequentially open in the direction away from the inlet 3. When it is necessary to aspirate saline from each of the filling bladders, only the inlet 3 needs to be aspirated. After the saline in the main channel 1 and balloon 2 of the first filling bladder is aspirated, a negative pressure is formed in the main channel 1 and balloon 2 of the first filling bladder. At this time, the main channel 1 and balloon 2 of the second filling bladder still contain saline, thus creating a pressure difference between the main channel 1 of the second filling bladder and the main channel 1 of the first filling bladder. When the pressure difference is greater than the critical opening pressure of the first capillary valve, the first capillary valve opens. The other capillary valves 5, other than the first capillary valve, also open using the same principle. This invention, through the setting of capillary valves, can control the opening of capillary valves without the need for additional control mechanisms; it only requires continuously injecting saline into the first filling bladder through the inlet 3. Simultaneously, the capillary valve 5 and the fluid inlet 3 are positioned on the main channel 1 in the fluid-filled sac section at one end of the balloon string, allowing the balloons 2 in each fluid-filled sac section to expand sequentially in the same direction, maximizing the number of stretches of the periosteum 13. In other embodiments, the control valve can be an electric valve, which is controlled to open and close by providing an electrical signal.

[0037] In this embodiment, as Figure 1As shown, each capillary valve 5 is configured such that its opening pressure increases with distance from the inlet 3. Along the direction away from the inlet 3, each capillary valve 5 is defined as the first capillary valve, the second capillary valve, the third capillary valve, ..., the Nth capillary valve. That is, the opening pressure of the second capillary valve is greater than that of the first capillary valve, the opening pressure of the third capillary valve is greater than that of the second capillary valve, and so on, with the opening pressure of the Nth capillary valve being greater than that of the (N-1)th capillary valve. One method to make the opening pressure of the second capillary valve greater than that of the first capillary valve is to have the same pipe diameter for both the first and second capillary valves, but with a longer pipe length for the second capillary valve than for the first capillary valve. Alternatively, the pipe lengths for both the first and second capillary valves can be the same, but with a smaller pipe diameter for the second capillary valve than for the first capillary valve. The capillary valve 5 is designed to open at an increasing pressure as it moves away from the inlet 3. This is intended to prevent multiple capillary valves 5 from opening simultaneously due to excessive saline injected through the inlet 3, which would reduce the number of times the periosteum 13 is stretched and thus affect the treatment effect. In other embodiments, the opening pressure of each capillary valve 5 may be the same.

[0038] In this embodiment, as Figure 2 and Figure 3 As shown, to improve the treatment effect on diabetic foot, medication needs to be administered to the stretched periosteum 13 to promote blood circulation. In conventional stretching procedures, medication is usually administered to the entire periosteum 13 area regardless of whether the periosteum 13 is stretched, undoubtedly resulting in significant waste, and excessive medication often causes adverse reactions. Therefore, the periosteum stretching device of this invention also includes several sub-supply tubes for containing the medication solution 4, with each filling bladder equipped with a corresponding sub-supply tube. The sub-supply tubes are positioned close to the balloon 2, and the outer wall of the sub-supply tube has a slanted cut extending into the interior of the sub-supply tube. The slanted cut refers to a long strip of slit cut at an angle on the wall of the sub-supply tube, not perpendicular to its axis, with the cut forming an acute or obtuse angle with the axis of the sub-supply tube. The slit extends obliquely along the wall of the sub-supply tube, and the cut surface is elliptical.

[0039] The drug delivery tube is configured such that when the balloon 2 inflates (i.e., the balloon 2 in the fluid-filled portion remains inflated for 2 days), the corresponding drug delivery tube is deformed by the compression of the balloon 2. The compression point of the drug delivery tube by the balloon 2 is located away from the oblique slit, and the oblique slit is located within the deformation area of ​​the drug delivery tube under compression. Therefore, when the drug delivery tube is a circular tube, the compressed part of the drug delivery tube becomes an elliptical tube, and the oblique slit is opened by compression, forming an opening that facilitates the outflow of the drug solution 4. The drug solution 4 can flow out from the opening formed by the opening of the oblique slit to the vicinity of the stretched periosteum 13.

[0040] The drug delivery tube is also configured such that when the balloon 2 contracts (i.e., the balloon 2 in the filling section is still in a contracted state 2c), the corresponding drug delivery tube is released from compression deformation and returns to its natural state, with the opening closed. At this time, the entire drug delivery tube is in a circular tube state. Compared to the open state of the oblique slit, the oblique slit is now only a small gap. Because the drug solution 4 itself has viscosity, the drug solution 4 is insufficient to flow out from this small gap, so the oblique slit prevents the drug solution 4 from flowing out.

[0041] This invention, through the oblique slit design, allows the drug delivery tube near the balloon 2 in its inflated state (2d) to flow with the drug solution 4, while preventing the drug delivery tube near the balloon 2 in its contracted state (2c) from flowing out. In other words, the periosteum 13 under tension receives the drug solution 4, while the periosteum 13 without tension does not receive the drug solution 4, effectively ensuring precise drug delivery. In other embodiments, a separate drug delivery tube with small holes around its perimeter can also be provided. This tube contains the drug solution 4, which flows out through the holes under gravity. The drug delivery tube is configured to be manually movable. During use, the drug delivery tube is positioned between the periosteum 13 and the periosteum 13. Simultaneously, the manually movable drug delivery tube only moves within the tensioned area of ​​the periosteum 13. Specifically, when the balloon 2 is just inflated, the manually movable drug delivery tube moves towards the balloon 2, allowing the drug solution 4 in the tube to flow to the corresponding periosteum 13.

[0042] In this embodiment, there are three ways to inflate the balloon 2 to squeeze the drug delivery tube, thereby opening the oblique slit to facilitate the outflow of the drug solution 4. These three methods will be described in detail below.

[0043] The first method: like Figure 2 and Figure 3 As shown, in a single inflatable bladder, the inflatable bladder includes a first balloon 2a disposed on the first side of the main channel 1 and a second balloon 2b disposed on the second side of the main channel 1, with a drug delivery tube disposed between the first balloon 2a and the second balloon 2b. The drug delivery tube is configured to be clamped by the inflated first balloon 2a and the second balloon 2b. Therefore, after the drug delivery tube is clamped, it is squeezed and deformed under the clamping force, thereby opening the oblique slit to form an opening that facilitates the outflow of the drug liquid 4. When both the first balloon 2a and the second balloon 2b are in the contracted state 2c, the first balloon 2a and the second balloon 2b do not exert a clamping force on the drug delivery tube, and the drug delivery tube is in its natural state.

[0044] The second method: like Figure 5As shown, the drug delivery tube is positioned on the side of the balloon string near the periosteum 13. When the balloon 2 inflates, the drug delivery tube, pressing against the periosteum 13, pushes the periosteum 13, causing it to stretch. This results in the drug delivery tube at the inflated portion of the balloon 2 being clamped between the balloon 2 and the periosteum 13, i.e., the drug delivery tube is compressed and deformed. For the drug delivery tube at the contracted portion of the balloon 2, since there are some gaps between the periosteum 13 and the periosteum 13, the drug delivery tube remains in its natural state. In this configuration, only one balloon 2 is needed in a single inflatable balloon section.

[0045] The third method: The difference from the second method is that in each inflatable bladder section, there is only one balloon 2, and the balloon 2 is annular, with the drug delivery tube passing through each balloon 2 sequentially. When the balloon 2 inflates, it clamps the drug delivery tube, causing the clamped tube to deform under pressure. Similarly, when the balloon is in a contracted state 2c, it cannot clamp the drug delivery tube, so the unclamped drug delivery tube remains in its natural state.

[0046] In this embodiment, as Figure 2 and Figure 3 As shown, in the first method mentioned above, adjacent fluid-filled bladder sections have corresponding drug delivery tubes connected to each other to form a drug delivery tube 6. A deformation buffer tube connects two adjacent drug delivery tubes. The deformation buffer tube is configured to prevent the drug delivery tube in its natural state from being deformed by the adjacent drug delivery tube in a deformed state. The deformation buffer tube can be a tube with a higher hardness than the drug delivery tube, such as a rubber tube for the drug delivery tube and a metal tube for the deformation buffer tube. Alternatively, the deformation buffer tube can be a corrugated tube, while the drug delivery tube remains a rubber tube. When one of the two adjacent fluid-filled bladder sections inflates, the balloon 2 in the other fluid-filled bladder section contracts. At this time, the drug delivery tube corresponding to the inflated fluid-filled portion of balloon 2 is deformed by compression, while the drug delivery tube corresponding to the contracted fluid-filled portion of balloon 2 should not be affected by the deformed drug delivery tube. Therefore, it is necessary to set up a deformation buffer tube so that the deformation force of the drug delivery tube is completely consumed within the deformation buffer tube. Simultaneously, a long drug delivery tube 6 is set parallel to the same balloon string. Therefore, during the insertion of the balloon string into the human body, the long drug delivery tube 6 will also enter the human body. This invention facilitates the implantation of the periosteal traction device by interconnecting the various drug delivery tubes. In other embodiments, the various drug delivery tubes can also be separated and set up individually. In this case, each drug delivery tube needs to have its own drug delivery channel connected to it to facilitate drug delivery.

[0047] In this embodiment, as Figure 6As shown, in the first method mentioned above, the drug delivery tube 6 is connected to the main channel 1 via a connector 7, with the oblique cut positioned away from the connector 7. The connector 7 can be an adhesive component or a thin rope. This invention, through the design of the connector 7, prevents the drug delivery tube 6 from easily drifting away from the balloon string during its entry into the human body. In other embodiments, a groove for accommodating the drug delivery tube 6 can also be provided on the main channel 1, similarly preventing the drug delivery tube 6 from drifting away from the balloon string during its entry into the human body.

[0048] In this embodiment, as Figure 1 and Figure 7 As shown, a valve body 8 connects the main channel 1 and the balloon 2. The valve body 8 is configured such that the flow from the main channel 1 to the balloon 2 is always open; that is, when saline solution is introduced into the main channel 1, the saline solution flows into the balloon 2 through the valve body 8. However, when the pressure difference between the balloon 2 and the main channel 1 is lower than the pressure setting value of the valve body 8, the flow from the balloon 2 to the main channel 1 is cut off; that is, when the pressure difference between the balloon 2 and the main channel 1 is not greater than or equal to the pressure setting value of the valve body 8, such as when the pressure difference between the saline solution pressure in the balloon 2 and the main channel 1 is less than the pressure setting value of the valve body 8, the saline solution in the balloon 2 cannot flow back into the main channel 1. The valve body 8 is also configured such that when the pressure difference between the balloon 2 and the main channel 1 is greater than or equal to the pressure setting value of the valve body 8, the channel flowing from the balloon 2 to the main channel 1 is opened; that is, when it is necessary to aspirate saline from the main channel 1 and the balloon 2, in the same inflatable balloon section, the saline in the main channel 1 is aspirated before the saline in the balloon 2, creating a negative pressure in the main channel 1. When the pressure difference between the saline in the balloon 2 and the negative pressure in the main channel 1 is greater than or equal to the pressure setting value of the valve body 8, the saline in the balloon 2 is aspirated into the main channel 1 via the valve body 8. This invention, through the valve body 8, ensures that the inflated balloon 2 will not contract without external force during the stretching of the periosteum 13. In other embodiments, the main channel 1 and the balloon 2 can also be directly connected without any valve.

[0049] In this embodiment, as Figure 7 and Figure 8As shown, the periosteal traction device of the present invention also includes a shape memory alloy sheet 9, which includes a base plate 9a and side plates 9b disposed on opposite sides of the base plate 9a. The shape memory alloy sheet 9 is configured such that, when the shape memory alloy sheet 9 is in the martensitic phase, the side plates 9b located on opposite sides of the base plate 9a are close to each other, and the shape memory alloy sheet 9 is tubular and wraps around the balloon string and the drug delivery tube. Specifically, before surgery, the shape memory alloy sheet 9, together with the balloon string and the drug delivery tube, is placed in ice water, and the shape memory alloy sheet 9 is bent into a tubular shape and wrapped around the balloon string and the drug delivery tube. Subsequently, the tubular shape memory alloy sheet 9, together with the balloon string and the drug delivery tube, is implanted through a minimally invasive incision between the periosteum 13 and the periosteum 13. The tubular shape memory alloy sheet 9 effectively protects the balloon string and the drug delivery tube from easy entry into the human body, and the balloon 2 is not easily damaged. When the shape memory alloy sheet 9, along with the balloon string and the drug delivery tubing, is brought to the tension position, the shape memory alloy sheet 9 heats up due to the influence of body temperature, and gradually transforms into the austenitic phase. During the transformation of the shape memory alloy sheet 9 from the martensitic phase to the austenitic phase, the side plates 9b located on opposite sides of the base plate 9a move away from each other. This continues until the shape memory alloy sheet 9 is in the austenitic phase, as... Figure 2 and Figure 3 As shown, the shape memory alloy sheet 9 is flat. Figure 8 As shown, during the transformation of the shape memory alloy sheet 9 from a tubular shape to a flat shape, the movement of the side plate 9b creates a large gap between the periosteum 13 and the periosteum 13, allowing the drug delivery tube sufficient space to remain in its natural state. After the periosteum 13 is stretched, before the drive balloon string passes through the micro-incision and leaves the body, an external device is needed to transform the shape memory alloy sheet 9 back into a tubular shape. Because this process is rather cumbersome, in other embodiments, the shape memory alloy sheet 9 may not be used.

[0050] In this embodiment, to facilitate better flow of the medication 4 from the opening formed by the oblique cut, the periosteal traction device of the present invention also includes a vibrator 15. After the periosteal membrane 13 is stretched, the vibrator 15 is positioned close to the skin surface, and the vibrator 15 is controlled to vibrate. The vibration waves of the vibrator 15 are transmitted to the drug delivery tube, which helps the medication 4 to flow out from the opening. In other embodiments, the vibrator 15 may not be provided.

[0051] In this embodiment, as Figure 9 As shown, the periosteal traction device of the present invention further includes an actuator, which includes a sheath tube 10 and a connecting rod 11 disposed within the sheath tube 10. A shape memory alloy sheet 9, a balloon string, and a drug delivery tube constitute a traction module 12. The traction module 12 is configured to be connected to the connecting rod 11, and when the shape memory alloy sheet 9 is in the martensitic phase, moving the connecting rod 11 allows the traction module 12 to enter into or extend out of the sheath tube 10. See also the attached diagram. Figure 10 As shown, the periosteal traction device of the present invention also includes a strap 16, and a vibrator 15 is fixed on the strap 16.

[0052] like Figure 9 and Figure 10 As shown, before the traction module 12 is inserted into the human body, the strap 16 is first tied to the thigh 17 of the patient with diabetic foot. Then, the connecting rod 11 is moved to allow the traction module 12 to enter the sheath 10. Next, the actuator is moved to allow the sheath 10 to pass through the micro-incision. During this process, the sheath 10 effectively protects the traction module 12. When it is about to reach the surgical position, the connecting rod 11 is moved so that the traction module 12 is fully extended out of the sheath 10, and the traction module 12 reaches between the periosteum 13 and the periosteum 13 to be stretched. The actuator also includes an infusion tube for supplying fluid to the inlet 3 to facilitate the inflation of the balloon 2. The present invention facilitates the placement of the traction module 12 to the surgical position through the actuator. In other embodiments, the strap 16 may be omitted, and an adhesive layer may be provided on the vibrator 15 so that the vibrator 15 can be adhered to the skin.

[0053] In summary, the periosteal traction device of the present invention, through the arrangement of the balloon string and control valve, allows for the sequential inflation of each balloon 2 in the inflated balloon section, thereby achieving precise control of the daily traction step length with minimal surgical trauma. Furthermore, by placing the inlet 3 on the main channel 1 in the inflated balloon section at one end of the balloon string, the size of the minimally invasive incision is reduced. The capillary valve design eliminates the need for an additional control mechanism to control its opening. The design also prevents multiple capillary valves 5 from opening simultaneously by increasing the opening pressure as the device moves away from the inlet 3. The oblique slit design effectively ensures precise drug delivery of the medication 4. Connecting the various drug delivery tubes facilitates implantation of the periosteal traction device. The connector 7 prevents the drug delivery tube 6 from drifting away from the balloon string during insertion into the body. Finally, the valve body 8 prevents the inflated balloon 2 from contracting without external force. Furthermore, the tubular shape of the shape memory alloy sheet 9 effectively protects the balloon string and drug delivery tubing, ensuring smooth entry into the body and preventing damage to the balloon 2. The vibrator 15 facilitates the outflow of the drug solution 4 from the opening. The actuator facilitates the placement of the traction module 12 at the surgical site.

[0054] It should be emphasized that the above are merely preferred embodiments of the present invention and are not intended to limit the present invention in any way. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention shall still fall within the scope of the technical solution of the present invention.

Claims

1. A periosteal traction device, comprising a plurality of fluid-filled sacs, wherein the fluid-filled sacs are connected in series in a row to form a balloon string, characterized in that, The inflatable bladder includes a main channel (1) and a balloon (2) connected to the main channel (1). Each main channel (1) in the inflatable bladder has a liquid inlet (3). The main channels (1) in adjacent inflatable bladders are connected by a control valve. The balloon (2) is configured such that each balloon (2) expands in the same direction after being inflated.

2. The periosteal traction device according to claim 1, characterized in that, It also includes several drug supply sub-tubes for containing liquid medicine (4), each of the filling bladders is equipped with a corresponding drug supply sub-tube, the drug supply sub-tubes are located close to the bladder (2), and the outer wall of the drug supply sub-tubes is provided with oblique cuts extending into the inside of the drug supply sub-tube pipe; The drug delivery tube is configured such that when the balloon (2) inflates, the corresponding drug delivery tube is deformed by the balloon (2), the compression point of the drug delivery tube by the balloon (2) is located away from the oblique cut, and the oblique cut is located in the deformation area of ​​the drug delivery tube under compression deformation, and the oblique cut opens to form an opening that facilitates the flow of the drug liquid (4); when the balloon (2) contracts, the corresponding drug delivery tube is released from compression deformation and is in a natural state, the opening is closed, and the oblique cut prevents the drug liquid (4) from flowing out.

3. The periosteal traction device according to claim 2, characterized in that, In a single inflatable bladder, the inflatable bladder includes a first balloon (2a) disposed on a first side of the main channel (1) and a second balloon (2b) disposed on a second side of the main channel (1), and the drug delivery tube is disposed between the first balloon (2a) and the second balloon (2b); the drug delivery tube is configured to be clamped by the inflated first balloon (2a) and the second balloon (2b).

4. The periosteal traction device according to claim 1, characterized in that, The control valve is a capillary valve (5).

5. The periosteal traction device according to claim 4, characterized in that, Each of the capillary valves (5) is configured such that the opening pressure of the capillary valve (5) increases as it moves away from the liquid inlet (3).

6. The periosteal traction device according to claim 2, characterized in that, The drug supply sub-tubes corresponding to adjacent filling bladders are connected to each other to form a drug supply tube (6). A deformation buffer tube is connected between two adjacent drug supply sub-tubes. The deformation buffer tube is configured to prevent the drug supply sub-tube in the natural state from being deformed by the adjacent drug supply sub-tube in the deformed state.

7. The periosteal traction device according to claim 6, characterized in that, The drug supply tube (6) is connected to the main channel (1) via a connector (7), and the oblique cut is set away from the connector (7).

8. The periosteal traction device according to claim 1, characterized in that, The fluid inlet (3) is located on the main channel (1) in the fluid-filled bladder at one end of the balloon string.

9. The periosteal traction device according to claim 1, characterized in that, A valve body (8) is connected between the main channel (1) and the balloon (2); the valve body (8) is configured to open the channel from the main channel (1) to the balloon (2); when the pressure difference between the balloon (2) and the main channel (1) is lower than the pressure setting value of the valve body (8), the channel from the balloon (2) to the main channel (1) is closed; when the pressure difference between the balloon (2) and the main channel (1) is greater than or equal to the pressure setting value of the valve body (8), the channel from the balloon (2) to the main channel (1) is opened.

10. The periosteal traction device according to claim 2, characterized in that, It also includes a shape memory alloy sheet (9), which includes a base plate (9a) and side plates (9b) disposed on opposite sides of the base plate (9a); the shape memory alloy sheet (9) is configured such that when the shape memory alloy sheet (9) is in the martensitic phase, the side plates (9b) located on opposite sides of the base plate (9a) are close to each other, the shape memory alloy sheet (9) is tubular and surrounds the balloon string and the drug delivery tube; during the transformation of the shape memory alloy sheet (9) from the martensitic phase to the austenitic phase, the side plates (9b) located on opposite sides of the base plate (9a) are far apart from each other; when the shape memory alloy sheet (9) is in the austenitic phase, the shape memory alloy sheet (9) is flat.

11. The periosteal traction device according to claim 10, characterized in that, It also includes an actuator, which includes a sheath tube (10) and a connecting rod (11) disposed in the sheath tube (10). The shape memory alloy sheet (9), the balloon string and the drug delivery tube form a tension module (12). The tension module (12) is configured to be connected to the connecting rod (11), and when the shape memory alloy sheet (9) is in the martensitic phase, the connecting rod (11) is moved, and the tension module (12) can enter into the sheath tube (10) or extend out of the sheath tube (10).

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