Periosteal distraction device

Abstract

The application relates to a periosteal distraction device and relates to the technical field of medical devices. The periosteal distraction device comprises an inflatable balloon, a connecting catheter and a balloon pressure charging mechanism. The connecting catheter is in communication with the inflatable balloon. The balloon pressure charging mechanism is connected with the connecting catheter and is used for charging contrast agent into the connecting catheter and the inflatable balloon. A flexible tight fixing ring is further arranged on the connecting catheter and is used for fixing the connecting catheter and the inflatable balloon. In the application, the inflatable balloon is used to replace the traditional steel plate made of hard material, so that the damage to the bone is avoided, and the risk of infection is reduced. Moreover, the inflatable balloon can adapt to various complex bone surface shapes, so that the safety and effectiveness of the operation are improved.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a periosteal traction device. Background Technology

[0002] Periosteal distraction is an effective treatment for non-healing wounds, pain, and foot necrosis caused by lower limb ischemia. This procedure involves dissecting the periosteum at a specific site and applying continuous traction to promote local blood circulation and tissue regeneration. With advancements in medical technology, periosteal distraction is increasingly widely used clinically, bringing significant therapeutic benefits to many patients.

[0003] The periosteal distraction device is one of the important medical instruments in periosteal distraction surgery. The procedure is as follows: After disinfection and draping at the site corresponding to the lesion, an incision is made in the skin and subcutaneous tissue to expose the periosteum. The periosteum is then transversely incised approximately 1.5 cm, closely adhering to the bone surface, and longitudinally dissected along the long axis of the bone. The periosteal distraction device is then inserted to slowly distract the periosteum, promoting the regeneration of a new microvascular system on the periosteum at the lesion site. This restores blood circulation, alleviates tissue necrosis caused by vascular occlusion, significantly improves the condition of patients with lower limb ischemic diseases, and enhances their quality of life.

[0004] Traditional periosteal distraction devices typically use rigid periosteal distraction plates. These plates require the use of hollow metal screws, adjusting nuts, and antibacterial bone pins for positioning, fixation, and adjustment to ensure stability and traction on the bone surface. The antibacterial bone pins, which penetrate the cortical bone twice for fixation, can easily damage the bone. Furthermore, the incision directly contacts the distraction plate, and the potential gaps between the hollow metal screws and antibacterial bone pins communicate directly with the medullary cavity, increasing the risk of infection. The rigid structure of the plate is also ill-suited to complex bone surface morphologies, making effective distraction impossible in certain areas. Additionally, traditional periosteal distraction devices rely heavily on the surgeon's experience and the patient's subjective feelings when adjusting tension, lacking quantifiable standards. This results in imprecise operation and susceptibility to human error; these problems severely impact surgical outcomes and patient recovery. Utility Model Content

[0005] To reduce surgical trauma and lower the risk of infection, this application provides a periosteal traction device.

[0006] The periosteal traction device provided in this application adopts the following technical solution: A periosteal traction device includes an inflatable balloon, a connecting catheter, and a balloon inflation mechanism. The connecting catheter is connected to the inflatable balloon, and the balloon inflation mechanism is connected to the connecting catheter and used to inflate the connecting catheter and the inflatable balloon with a contrast agent. The connecting catheter is also provided with a flexible, tight-fitting fixation loop for fixing the connecting catheter and the inflatable balloon.

[0007] By adopting the above-mentioned technical solution, this periosteal traction device uses an inflatable balloon instead of a traditional rigid steel plate, avoiding damage to the bone and reducing the risk of infection. A flexible, tight-fitting fixation loop is used to fix the inflatable balloon and connecting catheter to the periosteum. The inflatable balloon can easily deform to adapt to various complex bone surface morphologies, improving the safety and effectiveness of the surgery. Furthermore, the expansion and contraction are achieved by injecting contrast agent, which not only simplifies the surgical procedure but also achieves precise periosteal traction, reducing the workload of the surgeon and improving patient comfort and quality of life. In addition, in this application, the inflatable balloon and connecting catheter are inserted into the periosteum via minimally invasive guidance, with the puncture point far from the periosteal incision, greatly reducing the risk of soft tissue infection; it also does not damage the medullary cavity, eliminating the risk of bone infection; the entire device is a flexible tubing system, with minimal impact from joint movement, resulting in good patient comfort.

[0008] Optionally, the number of inflatable balloons is two or three, and all the inflatable balloons are connected in series side by side with intervals on the connecting catheter.

[0009] By employing the above technical solution, multiple inflatable balloons are connected in series side-by-side with intervals on the connecting catheter, enabling simultaneous traction at different locations of the periosteum. This ensures a uniform distribution of traction tension and avoids the localized stress concentration problems that may occur with a single balloon. Furthermore, the multi-balloon design allows for flexible adjustment of the position and number of balloons according to actual needs, adapting to different treatment requirements and improving the applicability and flexibility of the device.

[0010] Optionally, the inflatable balloon is made of TPE material or medical-grade silicone material. After being inflated, the inflatable balloon is cylindrical. Both ends of the inflatable balloon have hemispherical curved surfaces. The connecting catheter is coaxially arranged with the inflatable balloon.

[0011] By adopting the above technical solution, the inflatable balloon is made of TPE material or medical-grade silicone material, which has good biocompatibility and flexibility, and can adapt well to different bone surface morphologies, avoiding damage to the bone. After inflation, the inflatable balloon is cylindrical, with hemispherical curved surfaces at both ends, which helps to evenly distribute pressure, reduce local stress concentration, improve the traction effect, and effectively reduce damage to the periosteum caused by the inflatable balloon.

[0012] Optionally, one end of the connecting catheter is closed, and the other end is provided with a first interface and a second interface respectively; the balloon inflation mechanism includes a controller, a solvent container and an infusion pump, the infusion pump is connected to the solvent container and the first interface of the connecting catheter respectively; a pressure detection mechanism is connected to the second interface of the connecting catheter; the pressure detection mechanism and the infusion pump are both electrically connected to the controller.

[0013] By adopting the above technical solution, one end of the connecting catheter to the balloon inflation mechanism is far from the lesion area, thus not interfering with the function of the inflatable balloon. The inflation and traction of the balloon are automatically controlled by the balloon inflation mechanism, and the pressure inside the inflatable balloon is monitored by a pressure detection mechanism. This achieves precise control of the inflatable balloon, ensuring that the force applied during periosteal traction is uniform and controllable. This avoids the problems of relying on the doctor's experience and the patient's subjective feelings in traditional methods, improving the accuracy and safety of the surgery. In addition, the automated control system can monitor and adjust the pressure in real time, reducing the influence of human factors and making the surgery more standardized and reliable.

[0014] Optionally, the pressure detection mechanism is a pointer pressure gauge or a digital pressure gauge connected to the second interface of the connecting conduit.

[0015] By employing the aforementioned technical solutions, pointer or digital pressure gauges can monitor and display the pressure values ​​within the inflatable balloon in real time, providing doctors with an intuitive quantitative reference and ensuring precise control of periosteal tension. This not only reduces errors arising from reliance on doctor's experience and patient's subjective feelings in traditional methods but also improves the safety and effectiveness of the surgery. Furthermore, digital pressure readings are easy to record and analyze, aiding in postoperative evaluation and adjustments to the treatment plan.

[0016] Optionally, the periosteal traction device further includes a periosteal stripping guide needle for stripping the periostea and a guiding guide needle for guiding the inflatable balloon and connecting catheter into the stripped medial periosteal channel.

[0017] By employing the above-mentioned technical solutions, the periosteal dissection guide can accurately dissect the periosteum during the operation, ensuring thoroughness and safety. The guiding needle effectively guides the inflatable balloon and its connecting catheter into the medial channel of the dissected periosteum, ensuring smooth placement of the device in the target area and improving the ease of operation and success rate of the surgery. These designs not only simplify the surgical steps but also reduce damage to surrounding tissues and lower the risk of postoperative infection.

[0018] Optionally, the output end of the infusion pump is detachably connected to the first interface of the connecting conduit, and a sealing head is detachably connected to the first interface of the connecting conduit.

[0019] By adopting the above technical solution, the output end of the infusion pump can be detachably connected to the first interface of the connecting catheter. After pressurization, the infusion pump can be removed, facilitating patient movement and reducing maintenance requirements. The first interface of the connecting catheter can be sealed with a plug to prevent contamination and leakage, improving the safety and reliability of the device.

[0020] Optionally, a circumference measuring sensor is provided on the outer peripheral surface of the inflatable balloon along its circumference, and the circumference measuring sensor is connected to the controller via a wireless signal transmission module.

[0021] The perimeter measurement sensor can employ a similar sensor structure to those used for high-precision and continuous measurement of plant perimeter changes. The signal indicating perimeter changes is received via a metal cord covering the object being measured. This metal cord is made of a special alloy with a low coefficient of thermal expansion, achieving a measurement accuracy of 0.01 μm. By adopting this technical solution, the perimeter measurement sensor can perform high-precision and continuous measurement of changes in the circumference of the inflatable balloon, thereby enabling more accurate and reliable monitoring of balloon changes. This facilitates timely feedback on the effect of periosteal traction, allowing surgeons to more precisely control and adjust traction tension, ultimately improving surgical outcomes.

[0022] In summary, this application includes at least one of the following beneficial technical effects: 1. This application employs an inflatable balloon design and uses a flexible, tight-fitting fixation loop for fixation, which reduces iatrogenic damage to the bone and thus lowers the risk of bone infection.

[0023] 2. The inflatable balloon in this application can easily deform, has good adaptability to bone surface morphology, can meet the treatment needs of different sites, and improves the safety and effectiveness of surgery. 3. The inflatable balloon design used in this application allows for precise control of its expansion and contraction via a controller, achieving the effect of eliminating the need for frequent adjustments to the fixation pin position. Furthermore, it allows for automated timed adjustment, realizing intelligent monitoring and adjustment effects. Quantitative standard tension adjustment reduces interference from subjective factors.

[0024] 4. In this application, periosteal traction is achieved by expanding and contracting an inflatable balloon, which eliminates the need for complex mechanical adjustments, greatly simplifies the surgical procedure, shortens the operation time, and reduces the workload of doctors.

[0025] 5. This application eliminates the adjusting screw, reducing the number of screw wounds, lowering the risk of infection, and also facilitating care, minimizing the impact on the patient's daily activities. Attached Figure Description

[0026] Figure 1 This is a three-dimensional structural schematic diagram of the periosteal traction device in this application.

[0027] Figure 2 This is a partial structural schematic diagram of the periosteal traction device in this application.

[0028] Figure 3 This is a schematic diagram of the control flow of the periosteal traction device in this application.

[0029] In the picture: 10. Inflatable balloon; 20. Connecting conduit; 21. First interface; 22. Second interface; 30. Balloon inflation mechanism; 31. Solvent container; 32. Infusion pump; 33. Controller; 40. Fixed ring loop; 50. Pressure testing agency; 60. Sealing head; 70. Perimeter measurement sensor. Detailed Implementation

[0030] The following will be combined with the appendix Figure 1 -Appendix Figure 3 The technical solutions in the embodiments of this utility model are clearly and completely described herein. The described embodiments are only possible technical implementations of this utility model and not all possible implementations. Those skilled in the art can obtain other embodiments in conjunction with the embodiments of this utility model without creative effort, and these embodiments are also within the protection scope of this utility model.

[0031] Reference Figure 1 and Figure 2As shown, the periosteal traction device provided in this embodiment includes an inflatable balloon 10 and a connecting catheter 20. Multiple inflatable balloons 10 can be connected side-by-side in series with intervals on the connecting catheter 20, and the connecting catheter 20 is connected to the inflatable balloons 10. The multiple inflatable balloons 10 connected side-by-side in series with intervals on the connecting catheter 20 allow for simultaneous traction at different locations of the periosteum, ensuring a uniform distribution of traction tension and avoiding the localized stress concentration problem that may occur with a single balloon. Furthermore, the multi-balloon design allows for flexible adjustment of the position and number of balloons according to actual needs, adapting to different treatment requirements and improving the applicability and flexibility of the device. For example, the number of inflatable balloons 10 can be two or three. The inflatable balloon 10 is made of TPE or medical-grade silicone, exhibiting good biocompatibility and flexibility with human tissue. After inflation, the balloon 10 forms a cylindrical shape, with both ends having hemispherical curved surfaces to prevent damage to the periosteum when it travels within the periosteum. The connecting catheter 20 is coaxially positioned with the balloon 10. The entire inflatable balloon 10 maintains good adaptability to different bone surface morphologies, avoiding bone damage and helping to evenly distribute pressure, reduce local stress concentration, and improve the traction effect.

[0032] Combination Figure 3As shown in the embodiment of this application, the periosteal traction device also includes a balloon inflation mechanism 30 and a pressure detection mechanism 50. The balloon inflation mechanism 30 is connected to the connecting catheter 20 and is used to inflate the connecting catheter 20 and the inflatable balloon 10 with contrast agent. One end of the connecting catheter 20 is closed, and the other end is provided with a first interface 21 and a second interface 22. The balloon inflation mechanism 30 includes a controller 33, a solvent container 31, and an infusion pump 32. The infusion pump 32 is connected to the solvent container 31 and the first interface 21 of the connecting catheter 20. The output end of the infusion pump 32 is detachably connected to the first interface 21 of the connecting catheter 20, and a sealing head 60 is detachably connected to the first interface 21 of the connecting catheter 20. After the balloon inflation mechanism 30 inflates the inflatable balloon 10, the infusion pump 32 can be removed, which facilitates patient movement and reduces maintenance requirements. The first interface 21 of the connecting catheter 20 can be sealed by the sealing head 60 to prevent contamination and leakage, thereby improving the safety and reliability of the device. The pressure detection mechanism 50 is a pointer or digital pressure gauge connected to the second interface 22 of the connecting catheter 20; both the pressure detection mechanism 50 and the infusion pump 32 are electrically connected to the controller 33. The pointer or digital pressure gauge can monitor and display the pressure value inside the inflatable balloon 10 in real time, providing doctors with an intuitive quantitative reference and ensuring precise control of periosteal tension. This reduces errors caused by reliance on doctor's experience and patient's subjective feelings in traditional methods, improving the safety and effectiveness of the surgery. In addition, the digital pressure readings are easy to record and analyze, which helps in postoperative evaluation and adjustment of the treatment plan. The connecting catheter 20 is also equipped with a flexible tight-fitting fixation loop 40 for fixing the connecting catheter 20 and the inflatable balloon 10.

[0033] The periosteal distraction device in this application also includes a periosteal dissection guide needle for dissecting the periosteum and a guiding needle for guiding the inflatable balloon 10 and the connecting catheter 20 into the dissected medial periosteal channel. The periosteal dissection guide needle can accurately dissect the periosteum during the operation, ensuring thoroughness and safety of the dissection. The guiding needle can effectively guide the inflatable balloon 10 and its connecting catheter 20 into the dissected medial periosteal channel, ensuring smooth placement of the device in the target area and improving the ease of operation and success rate of the operation. These designs not only simplify the surgical steps but also reduce damage to surrounding tissues and lower the risk of postoperative infection.

[0034] Furthermore, in this embodiment, a circumference measurement sensor 70 is disposed on the outer peripheral surface of the inflatable balloon 10 along its circumference. The circumference measurement sensor 70 is connected to the controller 33 via a wireless signal transmission module. The circumference measurement sensor 70 can adopt a similar sensor structure for high-precision and continuous measurement of plant circumference changes. The signal of circumference change is received through a metal rope covering the object being measured. The metal rope is made of a special alloy with a low coefficient of thermal expansion. Its measurement accuracy can reach 0.01 μm. The circumference measurement sensor 70 can perform high-precision and continuous measurement of the circumference change of the inflatable balloon 10, thereby more accurately and reliably monitoring the changes of the inflatable balloon 10, which is beneficial for timely feedback on the effect of periosteal traction, thus helping doctors to more accurately control and adjust the traction tension and improve surgical outcomes.

[0035] The implementation principle of this embodiment is as follows: During use, the periosteal dissection guide needle is inserted into the tissue through a puncture operation. The skin and subcutaneous tissue are incised away from the puncture point, and part of the periosteum is incised and gently dissected. The guide needle is used to dissect the periosteum distally to a sufficient length, and then the guide needle is withdrawn. A guide needle with a certain degree of hardness and toughness is inserted into the connecting catheter 20 and the inflatable balloon 10. The guide needle presses against the closed end of the connecting catheter 20, and the guide needle, together with the connecting catheter 20, is inserted into the minimally invasively dissected periosteum channel. Then the guide needle is withdrawn; it is then fixed to the periosteum by suturing with the fixation loop 40. The periosteum and the corresponding skin incision are sutured. The balloon inflation mechanism 30 is used to gradually fill the inflatable balloon 10 with contrast agent. The position of the balloon is confirmed and the pressure is tested under fluoroscopy. Finally, the periosteum is slowly stretched, prompting the regeneration of a new microvascular system on the periosteum at the lesion site.

[0036] The periosteal traction device in this application utilizes an inflatable balloon 10 instead of a traditional rigid steel plate, avoiding damage to the bone and reducing the risk of infection. A flexible, tight-fitting fixation loop 40 secures the inflatable balloon 10 and connecting catheter 20 to the periosteum. The inflatable balloon 10 can easily deform to adapt to various complex bone surface morphologies, improving the safety and effectiveness of the surgery. Furthermore, the expansion and contraction are achieved through contrast agent injection, simplifying the surgical procedure and achieving precise periosteal traction, reducing the workload of the surgeon and improving patient comfort and quality of life. Additionally, the inflatable balloon 10 and connecting catheter 20 are inserted into the periosteum via minimally invasive guidance, with the puncture point far from the periosteal incision, significantly reducing the risk of soft tissue infection; it also avoids damage to the medullary cavity, eliminating the risk of bone infection; the entire device is a flexible tubing system, minimizing the impact of joint movement on the tubing and ensuring good patient comfort.

[0037] In this application, one end of the connecting catheter 20 connected to the balloon inflation mechanism 30 is far from the lesion area, so it does not interfere with the function of the inflatable balloon 10. The inflation and traction of the inflatable balloon 10 is automatically controlled by the balloon inflation mechanism 30, and the pressure detection mechanism 50 monitors the pressure inside the inflatable balloon 10, thereby achieving precise control of the inflatable balloon 10. This ensures that the force applied during periosteal traction is uniform and controllable, avoiding the problems of relying on the doctor's experience and the patient's subjective feelings in traditional methods, and improving the accuracy and safety of the surgery. In addition, the automated control system can monitor and adjust the pressure in real time, reducing the influence of human factors and making the surgery more standardized and reliable.

[0038] The embodiments described in this specific implementation are preferred embodiments of this application and are not intended to limit the scope of protection of this application. Identical components are represented by the same reference numerals. Therefore, all equivalent changes made to the structure, shape, and principle of this application should be covered within the scope of protection of this application.

Claims

1. A periosteal traction device, characterized in that, The periosteal traction device includes an inflatable balloon (10), a connecting catheter (20), and a balloon inflation mechanism (30). The connecting catheter (20) is connected to the inflatable balloon (10), and the balloon inflation mechanism (30) is connected to the connecting catheter (20) and is used to inflate the connecting catheter (20) and the inflatable balloon (10) with contrast agent. The connecting catheter (20) is also provided with a flexible tight-fitting fixation loop (40) for fixing the connecting catheter (20) and the inflatable balloon (10).

2. The periosteal traction device according to claim 1, characterized in that, The number of the inflatable balloons (10) is two or three, and all the inflatable balloons (10) are connected in series side by side at intervals on the connecting catheter (20).

3. The periosteal traction device according to claim 1 or 2, characterized in that, The inflatable balloon (10) is made of TPE material or medical grade silicone material. The inflatable balloon (10) is cylindrical after being inflated. The outer surfaces of both ends of the inflatable balloon (10) are hemispherical curved surfaces. The connecting catheter (20) is coaxially arranged with the inflatable balloon (10).

4. The periosteal traction device according to claim 1 or 2, characterized in that, One end of the connecting conduit (20) is closed, and the other end is provided with a first interface (21) and a second interface (22); the balloon inflation mechanism (30) includes a controller (33), a solvent container (31) and an infusion pump (32), the infusion pump (32) is connected to the solvent container (31) and the first interface (21) of the connecting conduit (20); a pressure detection mechanism (50) is connected to the second interface (22) of the connecting conduit (20); the pressure detection mechanism (50) and the infusion pump (32) are both electrically connected to the controller (33).

5. The periosteal traction device according to claim 4, characterized in that, The pressure detection mechanism (50) is a pointer pressure gauge or a digital pressure gauge connected to the second interface (22) of the connecting conduit (20).

6. The periosteal traction device according to claim 1 or 2, characterized in that, The periosteal traction device also includes a periosteal stripping guide needle for stripping the periosteal membrane and a guide needle for guiding the inflatable balloon (10) and the connecting catheter (20) into the inner channel of the stripped periosteal membrane.

7. The periosteal traction device according to claim 4, characterized in that, The output end of the infusion pump (32) is detachably connected to the first port (21) of the connecting conduit (20), and a plug (60) is detachably connected to the first port (21) of the connecting conduit (20).

8. The periosteal traction device according to claim 4, characterized in that, A circumference measurement sensor (70) is provided on the outer circumferential surface of the inflatable balloon (10) along its circumferential direction. The circumference measurement sensor (70) is connected to the controller (33) through a wireless signal transmission module.

Images