Balloon dilation device for osteotomy surgery

Abstract

The application provides a balloon dilatation device for osteotomy, and belongs to the technical field of medical instruments.The balloon dilatation device for osteotomy comprises a handle part, an injection inlet, balloon bodies A and B, and the injection inlet is arranged on one side of the handle part, and the balloon bodies A and B are connected with the handle part respectively.Two balloon bodies that can be independently or synchronously controlled are arranged, and the relative size of the front and rear gaps of the osteotomy surface can be accurately and flexibly adjusted.The working principle is that fluid is injected into the front and rear balloons respectively, and the differential expansion of the front and rear gaps can be realized.This design enables doctors to adjust the tibial plateau posterior slope angle to the ideal angle according to the accurate requirements of the surgical plan, and the adjustment can be completed only by controlling the expansion degree of different balloons, thereby realizing the fine and one-time control of the three-dimensional spatial form of the osteotomy, and effectively avoiding the problems of precision deviation and low surgical efficiency caused by repeated manual adjustment of traditional instruments.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a balloon dilation device for osteotomy surgery. Background Technology

[0002] The purpose of high tibial osteotomy (HTO) is to restore the lower limb alignment by performing a high osteotomy on the proximal end of the tibia, thereby relieving joint pain, reducing arthritis symptoms, prolonging the life of the knee joint, avoiding or delaying joint replacement as much as possible, which is in line with the concept of knee preservation.

[0003] The osteotomy surface of the medial open HTO is a three-dimensional structure with two osteotomy gaps, anterior and posterior. Generally, it is required that the anterior gap be 2 / 3 of the posterior gap to maintain normal tibial plateau posterior tilt. The actual tibial plateau posterior tilt angle is also affected by factors such as cartilage and meniscus, and therefore is smaller than the bony plateau posterior tilt angle. For patients with partial cruciate ligament injury, the tibial plateau posterior tilt angle needs to be increased or decreased according to the patient's tibial deformity. Currently, the conventional HTO osteotomy opening method uses instruments such as bone chisels, retractors, angle rulers, and gap measuring instruments to open the anterior and posterior gaps at equal angles, and then manually adjusts the posterior tilt angle. This operation is difficult, has poor precision, and is prone to loss of opening and reduction angle, requiring multiple adjustments, resulting in excessively long operation time and increased surgical risks for patients. Relying on manual instruments for multi-step coordinated operations, this procedure is highly dependent on the surgeon's experience. Independent control of the anterior-posterior gap is difficult, making it hard to achieve precise, one-time adjustment of the anterior-posterior gap ratio. Multiple attempts and adjustments are often required to approach the target angle, prolonging the operation time. After finding the ideal angle, the retractor or measuring block must be removed before the internal fixation plate can be implanted and screws fixed. During the transition between instrument removal and plate implantation, the corrected osteotomy surface lacks continuous and stable internal support, making it prone to slight displacement or retraction. This can lead to partial or complete loss of the carefully adjusted retractor angle, affecting the final surgical outcome. Mechanical retractors apply concentrated point or line force, which may cause stress damage or splitting of local bone. Furthermore, the magnitude of the retractor force depends entirely on the surgeon's feel, lacking quantitative standards and buffering, and carries the risk of over-retraction. Summary of the Invention

[0004] The purpose of this invention is to provide a balloon dilation device for osteotomy surgery, aiming to solve the problems in existing technologies where, during the transition between instrument withdrawal and plate implantation, the corrected osteotomy surface lacks continuous and stable internal support, making it prone to slight displacement or retraction. This can lead to partial or complete loss of the carefully adjusted dilation angle, affecting the final surgical outcome. Mechanical dilatators apply concentrated point or line forces, which may cause stress damage or fracture of the local bone. Furthermore, the dilation force depends entirely on the surgeon's feel, lacking quantitative standards and buffering, and carries the risk of over-dilation.

[0005] To achieve the above objectives, the present invention provides the following technical solution: A balloon dilation device for osteotomy surgery, comprising: handle part; The injection port is located on one side of the handle. The balloon body A and the balloon body B are respectively connected to the handle portion; A support plate is placed in the osteotomy gap and is used to accommodate balloon body A and balloon body B; A pressure supply device, connected to an injection port, for selectively or synchronously injecting fluid through a first balloon and a second balloon.

[0006] As a preferred embodiment of the present invention, two balloon limiting grooves are formed on the surface of the support plate, and the first balloon body and the second balloon body are accommodated in the corresponding balloon limiting grooves in the uninflated state.

[0007] As a preferred embodiment of the present invention, an inner tube and a core tube are provided between the balloon body A and the balloon body B and the handle portion, and an outer tube and a protective sleeve are fitted on the surface of the inner tube and the core tube.

[0008] In a preferred embodiment of the present invention, the support plate is made of a flexible material.

[0009] As a preferred embodiment of the present invention, the handle portion is provided with a control valve for controlling the fluid passage to the first balloon and the second balloon.

[0010] In a preferred embodiment of the present invention, the pressure supply device is a balloon dilation pressure pump, which is connected to the handle.

[0011] As a preferred embodiment of the present invention, the first and second balloons can provide continuous and stable support for the support plate after expansion.

[0012] As a preferred embodiment of the present invention, the outer tube is provided with a through hole, which communicates with the cavities of the core tube and the inner tube.

[0013] Compared with the prior art, the beneficial effects of the present invention are: 1. The device features two independently or synchronously controllable balloons, allowing for precise and flexible adjustment of the relative size of the anterior and posterior spaces before and after the osteotomy. Its working principle involves injecting fluid into the anterior and posterior balloons respectively, achieving differentiated expansion of the anterior and posterior spaces. This design enables surgeons to precisely adjust the tibial plateau tilt angle to the ideal angle according to the specific needs of the surgical plan, simply by controlling the expansion degree of different balloons. This achieves refined, one-time control of the three-dimensional spatial morphology of the osteotomy, effectively avoiding the precision deviations and low surgical efficiency caused by repeated manual adjustments using traditional instruments.

[0014] 2. It can provide continuous, uniform, and stable support during and after expansion. The inflated balloon, with its inherent physical properties, applies flexible planar support to the support plate and osteotomy surface. This not only avoids the stress concentration risk associated with traditional rigid instruments, but more importantly, it can firmly maintain the corrected osteotomy gap angle and lower limb force line after angle adjustment and before implantation of the internal fixation plate. This completely solves the angle loss problem that easily occurs between the removal of the retractor and the implantation of the plate in traditional surgery, greatly improving the controllability of the surgery and the reliability of the final corrective effect.

[0015] 3. By integrating multiple key surgical steps such as dislocation, precise adjustment, and maintenance of repositioning into one unit, the surgical procedure is simplified, significantly shortening the surgical time required for repeated instrument adjustments and measurements. The device is intuitive to operate, lowering the technical threshold of the surgery and reducing over-reliance on the surgeon's personal experience, thus contributing to improved surgical standardization. Ultimately, by achieving more precise correction, more stable maintenance, and more efficient operation, this invention not only improves postoperative biomechanical outcomes for patients but also effectively reduces potential surgical risks associated with complex and time-consuming procedures, demonstrating significant clinical practical value and promising prospects for wider application. Attached Figure Description

[0016] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used in conjunction with embodiments of the invention to explain the invention and do not constitute a limitation thereof. In the drawings: Figure 1 This is a front perspective view of the present invention; Figure 2 This is a top view of the present invention; Figure 3 This is the right view in this invention; Figure 4 This is an enlarged structural schematic diagram of the balloon body in this invention; Figure 5 This is a schematic diagram of the balloon dilation pressure pump in this invention; Figure 6 For the present invention Figure 1 Enlarged structural diagram of the central support plate.

[0017] In the diagram: 1. Balloon body A; 2. Balloon body B; 3. Support plate; 4. Outer tube; 5. Sheath; 6. Handle; 7. Injection port; 8. Core tube; 9. Inner tube; 10. Through hole; 11. Balloon dilation pressure pump; 12. Balloon limiting groove. Detailed Implementation

[0018] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. 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.

[0019] Example 1

[0020] Please see Figures 1-6 The present invention provides the following technical solutions: A balloon dilation device for osteotomy surgery, comprising: handle part 6; Inlet 7, the injection port 7 is located on one side of the handle part 6; The balloon body A1 and the balloon body B2 are respectively connected to the handle part 6; Support plate 3 is placed in the osteotomy gap and is used to accommodate balloon body A1 and balloon body B2. A pressure supply device is connected to the injection port 7 for selectively or synchronously injecting fluid through the first balloon 1 and the second balloon 2.

[0021] In a specific embodiment of the present invention, when performing a high tibial osteotomy, the proximal end of the tibia is first osteotomized using an oscillating saw to form two osteotomy gaps, one anterior and one posterior. Next, a support plate 3 is placed into the osteotomy gap along the working channel, and the positioning groove 12 on the support plate 3 is aligned with the expected opening position. Then, balloon bodies A1 and B2 are placed in the anterior and posterior positioning grooves 12 of the support plate 3, respectively, and guided to the osteotomy position via the handle 6 and the outer tube 4. When the balloon... After the balloon A1 and balloon B2 reach their predetermined positions, the pressure supply device 11 is connected to the injection port 7, and fluid is slowly injected into the balloon A1 and balloon B2 through the injection port 7. As the balloon A1 and balloon B2 gradually expand under the fluid pressure, the expanded balloon A1 and balloon B2 will push against the front and rear parts of the support plate 3 respectively, thereby opening the osteotomy gap to the required angle. During this process, the pressure supply device 11 can independently control the pressure of the balloon A1 and balloon B2. The expansion degree is adjusted to achieve differentiated opening of the anterior and posterior gaps, thereby precisely adjusting the posterior tilt angle of the tibial plateau. After the opening angle reaches the expected value and the lower limb alignment is restored, a bone plate is used for fixation. After fixation, the pressure supply device 11 is released, allowing balloons A1 and B2 to return to their contracted state. Subsequently, the balloon catheter and inner tube 9 are removed sequentially, and finally, the support plate 3 is removed from the osteotomy gap. By setting two independently controllable balloons A1 and B2, combined with the support plate 3 with positioning groove 12, precise and differentiated opening of the anterior and posterior gaps can be achieved, thereby accurately adjusting the posterior tilt angle of the tibial plateau. The entire opening process is completed in one operation without repeated adjustments, significantly shortening the operation time. After expansion, balloons A1 and B2 can provide continuous and stable support to the osteotomy surface, effectively preventing angle loss and reducing surgical difficulty and risk. The device has a simple structure, is easy to operate, and is suitable for various osteotomy opening needs, showing good clinical application prospects.

[0022] Please refer to the details. Figures 1-6 The support plate 3 has two balloon limiting grooves 12 on its surface. The first balloon body 1 and the second balloon body 2 are accommodated in the corresponding balloon limiting grooves 12 in the uninflated state.

[0023] In this embodiment: when balloon bodies A1 and B2 need to be precisely positioned on the support plate 3, two grooves, namely balloon limiting grooves 12, are pre-processed on the upper surface of the support plate 3 to match the shape of balloon bodies A1 and B2. When the support plate 3 is placed, balloon bodies A1 and B2, which are in an uninflated vacuum folded state, are respectively embedded into the corresponding balloon limiting grooves 12. At this time, the balloon limiting grooves 12 can effectively restrict the lateral displacement of balloon bodies A1 and B2 on the surface of the support plate 3, ensuring that they are always in the predetermined anterior and posterior positions during the expansion process, thereby realizing independent and precise pushing of the anterior and posterior parts of the osteotomy gap.

[0024] Please refer to the details. Figures 1-6 An inner tube 9 and a core tube 8 are provided between the balloon body A1 and the balloon body B2 and the handle part 6. An outer tube 4 and a sheath 5 are sleeved on the surface of the inner tube 9 and the core tube 8.

[0025] In this embodiment: When assembling the device and establishing the fluid channel, an inner tube 9 and a core tube 8 extend from the inside of the handle part 6. The lumen of the inner tube 9 is used to deliver expansion fluid to the balloon body A1 and balloon body B2, while the core tube 8 can provide a channel for the guidewire or other instruments or serve as a reinforcing structure. The outer tube 4 and the sheath 5 are sequentially sleeved on the outer layers of the inner tube 9 and the core tube 8. The outer tube 4 is a rigid or semi-rigid tube used to protect the internal tubing and transmit the pushing force. The sheath 5 is a flexible sleeve that covers the outside of the outer tube 4 and is used to protect the tissue and reduce friction during surgical implantation. This multi-layered tubular structure ensures the reliability of fluid delivery, the operational rigidity of the device, and the safety of the implantation process.

[0026] Please refer to the details. Figures 1-6 The support plate 3 is made of flexible material.

[0027] In this embodiment: when the support plate 3 is placed in the osteotomy gap and bears the expansion force of the balloon body A1 and the balloon body B2, since the support plate 3 is made of medical-grade silicone, polyurethane or other biocompatible flexible materials, it can undergo elastic deformation under the push of the balloon body A1 and the balloon body B2, conforming to the irregular shape of the bone osteotomy surface; this flexible characteristic allows the support plate 3 to form a more close contact with the bone surface and a more uniform stress distribution, avoiding local stress concentration that could damage bone tissue. At the same time, it is also beneficial for the support plate 3 to better maintain the restored lower limb force line position after the opening angle is adjusted.

[0028] Please refer to the details. Figures 1-6 The handle 6 is equipped with a control valve that controls the fluid passage to the first balloon 1 and the second balloon 2.

[0029] In this embodiment: when it is necessary to independently or synchronously control the expansion of balloon A1 and balloon B2, the operator operates through the control valve provided on the handle 6; the control valve can be a multi-way valve or two independent switching valves, which are respectively connected to the branches of the inner tube 9 leading to balloon A1 and balloon B2; when the knob or lever is in the first position, the fluid of the pressure supply device 11 is simultaneously supplied to balloon A1 and balloon B2 to achieve synchronous expansion; when the knob or lever is switched to the second or third position, fluid can be selectively injected into balloon A1 or balloon B2 only to achieve differential and precise adjustment of the anterior and posterior osteotomy gap, thereby flexibly controlling the tibial plateau posterior tilt angle.

[0030] Please refer to the details. Figures 1-6The pressure supply device is a balloon dilation pressure pump 11, which is connected to the handle part 6.

[0031] In this embodiment: when a controllable inflation pressure is required for balloon bodies A1 and B2, a dedicated balloon dilation pressure pump 11 is used; the pressure pump 11 is connected to the injection port 7 on the handle 6 via tubing; the balloon dilation pressure pump 11 typically includes a syringe-type handle with a pressure gauge, and the operator can slowly push its piston to deliver fluids such as saline at a controllable pressure and flow rate through the injection port 7, the control valve in the handle 6, and the inner tube 9 to the target balloon bodies 1 and 2; the pressure gauge can display the current pressure in real time to ensure that the dilation process is carried out within a safe pressure range and to avoid over-dilation and tissue damage.

[0032] Please refer to the details. Figures 1-6 The first balloon 1 and the second balloon 2, after expansion, can provide continuous and stable support for the support plate 3.

[0033] In this embodiment: After the balloon bodies A1 and B2 are injected with fluid and fully expanded by the balloon expansion pressure pump 11, a stable static pressure is formed inside them; the balloon bodies A1 and B2 in the expanded state, with their inherent shape and pressure, apply a continuous and uniform radial support force to the anterior and posterior parts of the osteotomy surface through the support plate 3; this support force will not decay or be lost before the bone plate is fixed, and can reliably maintain the adjusted tibial plateau posterior tilt angle and lower limb force line, providing a stable working environment for surgeons to perform internal fixation operations, and completely solving the problem that traditional instruments are prone to loss of angle due to loosening or displacement after being opened.

[0034] Please refer to the details. Figures 1-6 The outer tube 4 is provided with a through hole 10, which is connected to the lumen of the core tube 8 and the inner tube 9.

[0035] In this embodiment: when it is necessary to use a guidewire, inject drugs, or irrigate after the balloon dilation device is in place during surgery, one or more through holes 10 provided on the side wall of the outer tube 4 can be used; these through holes 10 are connected to the lumen of the inner core tube 8 and / or the inner tube 9; for example, when the through hole 10 is connected to the core tube 8, the guidewire can be inserted from the tail end of the handle part 6, pass through the core tube 8 and exit from the through hole 10, providing additional guidance or fixation for the device; or, when the through hole 10 is connected to the auxiliary cavity of the inner tube 9, it can be used to locally inject saline for irrigation or inject drugs into the dilated area, increasing the functionality of the device and the convenience of the surgery.

[0036] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A balloon dilation device for osteotomy surgery, characterized in that: include: handle part (6); Injection port (7), the injection port (7) is located on one side of the handle (6); The balloon body A (1) and the balloon body B (2) are respectively connected to the handle part (6); Support plate (3), which is placed in the osteotomy gap, is used to accommodate balloon body A (1) and balloon body B (2). A pressure supply device, which is connected to an injection port (7), is used to selectively or synchronously inject fluid through a first balloon (1) and a second balloon (2).

2. The balloon dilation device for osteotomy surgery according to claim 1, characterized in that: The support plate (3) has two balloon limiting grooves (12) on its surface. The first balloon body (1) and the second balloon body (2) are accommodated in the corresponding balloon limiting grooves (12) in the uninflated state.

3. The balloon dilation device for osteotomy surgery according to claim 2, characterized in that: An inner tube (9) and a core tube (8) are provided between the balloon body A (1) and the balloon body B (2) and the handle part (6), and an outer tube (4) and a sheath (5) are sleeved on the surface of the inner tube (9) and the core tube (8).

4. The balloon dilation device for osteotomy surgery according to claim 3, characterized in that: The support plate (3) is made of flexible material.

5. The balloon dilation device for osteotomy surgery according to claim 4, characterized in that: The handle (6) is provided with a control valve that controls the fluid passage to the first balloon (1) and the second balloon (2).

6. The balloon dilation device for osteotomy surgery according to claim 5, characterized in that: The pressure supply device is a balloon dilation pressure pump (11), which is connected to the handle (6).

7. The balloon dilation device for osteotomy surgery according to claim 6, characterized in that: The first balloon (1) and the second balloon (2) can provide continuous and stable support for the support plate (3) after inflation.

8. The balloon dilation device for osteotomy surgery according to claim 7, characterized in that: The outer tube (4) is provided with a through hole (10), which is connected to the lumen of the core tube (8) and the inner tube (9).

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