A thoracoscope rib plate fixator and fixing method

Abstract

The present application relates to the technical field of medical devices, in particular to a thoracic surgery device, in particular to a rib plate fixator under thoracoscope and a fixing method, which is suitable for the internal fixation equipment and the matching fixing method of the minimally invasive repair of rib fracture combined with the endoscopic technology. The present application aims to provide a memory alloy rib fracture internal fixator or bone plate which is convenient to install, reasonable in structure, safe and reliable, and meets the minimally invasive surgery, so as to complete the minimally invasive surgery of rib fracture fixation under the thoracoscope chest wall subcutaneous or muscle tunnel. Through the split design of the embracing arm, the position of the affected bone under the thoracoscope is adjusted conveniently, the surgical obstacles caused by the early recovery of the embracing arm are reduced, and the main purpose is to reduce the recovery of the product embracing arm due to the influence of the chest cavity environment during installation, reduce the operation time, and provide better medical device products for patients.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to thoracic surgical instruments, and more specifically to a thoracoscopic rib plate fixator and fixation method, applicable to internal fixation equipment and supporting fixation methods for minimally invasive repair of rib fractures using thoracoscopic techniques. Background Technology

[0002] Rib fractures are the most common type of chest trauma, accounting for 10%-15% of all fractures. Traditional treatment involves making a large incision to directly expose the fracture site and using bone plates / screws for fixation. This may damage the pleura, lung tissue, or blood vessels / nerves, leading to long hospital stays and a high risk of pulmonary complications.

[0003] Thoracoscopic-assisted rib internal fixation offers unique advantages in treating rib fractures. The main steps involve accurately locating and adjusting the position of the rib fracture using a thoracoscope, and then fixing the fracture with internal fixation materials. Internal fixation plates and screws are commonly used materials that stabilize the rib fracture ends, accelerate fracture healing, and reduce patient pain. The minimally invasive nature of thoracoscopic-assisted rib internal fixation results in less postoperative pain, shorter recovery time, and a lower incidence of postoperative complications. With continuous advancements in medical technology, thoracoscopic-assisted rib internal fixation has achieved significant results. High-definition angle and direct-view endoscopes, as well as robot-assisted techniques, have made this procedure safer and more precise. These innovative technologies provide better visualization and operational accuracy, reducing surgical trauma and complications. Our company already has corresponding thoracoscopic rib fixation products. Because the products are made of shape memory alloy material, they need to be installed on the affected bone in an open state. When using practical tools inside the thoracoscopic cavity, the installation time is relatively long, and the product will sometimes return to its original shape before it is fully installed. To address this issue, we have improved the structure of our thoracoscopic rib fixation products. Summary of the Invention

[0004] The purpose of this invention is to provide a shape memory alloy rib fracture fixation device or bone plate that is easy to install, has a reasonable structure, is safe and reliable, and meets the requirements of minimally invasive surgery, so as to complete minimally invasive surgery for rib fracture fixation through subcutaneous or submuscular tunneling of the chest wall in thoracoscopic surgery.

[0005] A thoracoscopic rib plate fixator includes a bone plate assembly and a fixator assembly; the bone plate assembly and the fixator assembly are made of nickel-titanium shape memory alloy; the bone plate assembly and the fixator assembly expand and open in an ice-water mixture at 0-5℃, and the bone plate assembly and the fixator assembly contract and shrink at 34-38℃. The bone plate assembly includes a bone fixation plate, a bone circumferential arm, bone mounting holes, and an anti-slip tooth assembly; the bone fixation plate has bone mounting holes, the circumferential arm is located on one side of the fixation plate, and the anti-slip tooth assembly is located on the other side of the fixation plate; The fastener assembly includes a mounting plate, mounting holes, and a retaining arm; the mounting hole is provided on the mounting plate; retaining arms are provided on both sides of the mounting plate; The fixation plate of the fixator assembly fits into the bone fixation plate of the bone plate assembly, and the circumferential arm circumferentially locks the bone fixation plate.

[0006] The anti-slip tooth assembly of the bone plate assembly consists of multiple parallel tooth-like protrusions. There are multiple sets of anti-slip tooth assemblies, which are arranged at intervals. The circumferential arm is located at the gap between two adjacent sets of anti-slip tooth assemblies.

[0007] The anti-slip tooth assembly of the bone plate assembly consists of multiple parallel tooth-like protrusions. There are two sets of anti-slip tooth assemblies, which are arranged at intervals. The circumferential arm is located at the gap between the two sets of anti-slip tooth assemblies.

[0008] The bone plate assembly and the fixator assembly are interlocked and circumferentially connected.

[0009] The bone plate assembly and the fixator assembly are arranged in a cross shape.

[0010] The bone fixation plate of the bone plate assembly is arc-shaped and fits against the rib.

[0011] The fixation plate is in close contact with the bone fixation plate, and the outer edge of the fixation plate extends along the axial direction of the bone fixation plate.

[0012] A method for fixing a rib plate fixator under thoracoscopic guidance includes the following steps: S1. Unfold and open the bone plate assembly and fixation assembly in a 0~5℃ ice-water mixture; S2. Move the bone plate assembly to the side of the affected bone to be fixed, and form a fixed ring end by the ring arm contracting at 30-35℃ to fix the bone plate assembly to the affected bone. S3. Adjust the position of the fixation assembly, use the circumferential arm to circumferentially lock the bone fixation plate and the affected bone, and at 30-35℃, perform a secondary fixation on the circumferentially contracted end. The circumferential arm will press the anti-slip tooth assembly tightly against the affected bone.

[0013] In steps S1 and S2, a laparoscopic tool is used to connect to the bone mounting hole or mounting hole with a snap-fit ​​mechanism, and the laparoscopic tool moves the bone plate assembly and the fixator assembly to adjust their positions.

[0014] The purpose of this invention is to provide a shape-memory alloy rib fracture fixation device or plate that is easy to install, structurally sound, safe, reliable, and suitable for minimally invasive surgery, enabling thoracoscopic fixation of rib fractures via subcutaneous or submuscular tunneling of the chest wall. The modular design of the wrap-around arm facilitates adjustment of the affected bone position during thoracoscopic surgery, reducing surgical obstacles caused by premature recovery of the wrap-around arm. The main objective is to minimize the impact of the thoracic environment on the product during installation, thus reducing surgical time and providing patients with a superior medical device.

[0015] This invention comprises components assembled using shape memory alloy materials and anti-slip teeth. Component two recovers its shape in a warm water environment. Because the fixation plate 201 is in close contact with the bone fixation plate 103, with the outer edge of the fixation plate 201 extending axially along the bone fixation plate 103 and having the same curvature as the bone fixation plate 103, it will fit tightly after recovering its shape. After installation, the circumferential arm 203 is located at the gap between a pair of anti-slip teeth 104, forming a stable mechanical structure to prevent dislodgement and reducing the uncontrollable risks associated with complex structures. It solves the problems of increased manufacturing difficulty, reduced reliability, and increased difficulty in endoscopic implantation caused by the use of screws in traditional bone plates; it also avoids secondary damage to the affected bone caused by traditional screw fixation, making it particularly suitable for fixing bones with osteoporosis or bone lesions. Fixation via a circumferential method eliminates the need for screw fixation. Attached Figure Description

[0016] Figure 1 This is a side view of the bone plate assembly of the present invention; Figure 2 This is a top view of the bone plate assembly of the present invention; Figure 3 for Figure 1 Sectional view along axis AA; Figure 4 This is a side view of the bone plate assembly with three sets of anti-slip teeth according to the present invention; Figure 5 This is a top view of the three-group anti-slip tooth bone plate assembly of the present invention; Figure 6 This is a side view of the retainer assembly of the present invention; Figure 7 This is a top view of the retainer assembly of the present invention; Figure 8 This is a side view of the combined state of the present invention; Figure 9 This is a top view of the combined state of the present invention; Figure 10 A schematic diagram showing the clamping and installation of laparoscopic tools and bone plate components; Figure 11 A schematic diagram showing the clamping of laparoscopic tools and fixation components; Figure 12 This is a schematic diagram of the fixture assembly.

[0017] The components are labeled as follows: bone plate assembly 1, fixator assembly 2, bone circumferential arm 101, bone mounting hole 102, bone fixation plate 103, anti-slip tooth assembly 104, fixation plate 201, mounting hole 202, and circumferential arm 203. Detailed Implementation

[0018] A thoracoscopic rib plate fixator includes a bone plate assembly 1 and a fixator assembly 2; the bone plate assembly 1 and the fixator assembly 2 are made of nickel-titanium shape memory alloy; the bone plate assembly 1 and the fixator assembly 2 expand and open in an ice-water mixture at 0-5℃, and the bone plate assembly 1 and the fixator assembly 2 shrink and contract at 34-38℃. The bone plate assembly 1 includes a bone fixation plate 103, a bone circumferential arm 101, a bone mounting hole 102, and an anti-slip tooth assembly 104; the bone fixation plate 103 has a bone mounting hole 102, the circumferential arm 101 is disposed on one side of the fixation plate 103; the anti-slip tooth assembly 104 is disposed on the other side of the fixation plate 103. The fastener assembly 2 includes a fixing plate 201, mounting holes 202, and a retaining arm 203; the fixing plate 201 has mounting holes 202; and retaining arms 203 are respectively provided on both sides of the fixing plate 201. The fixation plate 201 of the fixator assembly 2 is attached to the bone fixation plate 103 of the bone plate assembly 1, and the circumferential arm 203 circumferentially locks the bone fixation plate 103.

[0019] The anti-slip tooth group 104 of the bone plate assembly 1 consists of multiple parallel tooth-like protrusions. Multiple sets of anti-slip tooth groups 104 are provided, spaced apart. The circumferential arm 203 is located at the gap between two adjacent sets of anti-slip tooth groups 104. The relative position of the fixator assembly 2 and the bone plate assembly 1 can be adjusted by clamping different anti-slip tooth groups 104. The anti-slip tooth group 104 of the bone plate assembly 1 consists of multiple parallel tooth-like protrusions. Two sets of anti-slip tooth groups 104 are provided, spaced apart. The circumferential arm 203 is located at the gap between the two sets of anti-slip tooth groups 104. The positions of the two sets of anti-slip tooth groups 104 can be designed and adjusted during prefabrication. The relative position of the fixator assembly 2 and the bone plate assembly 1 is fixed. In actual use, either of the two types of fixators can be flexibly selected for use.

[0020] The bone plate assembly 1 and the fixator assembly 2 are interlocked and circumferentially connected. The bone plate assembly 1 and the fixator assembly 2 are arranged in a cross shape. The bone fixation plate 103 of the bone plate assembly 1 is arc-shaped and fits snugly against the rib. This ensures a tight fit between the bone plate assembly 1 and the fixator assembly 2, and they are circumferentially supported by the bone circumferential arms 101 and 203, respectively, and the affected bone and bone plate assembly 1 are then fixed together by the circumferential arms 203. The fixation plate 201 is in close contact with the bone fixation plate 103, and the outer edge of the fixation plate 201 extends axially along the bone fixation plate 103. This increases the contact area between the bone plate assembly 1 and the fixator assembly 2 and prevents stress concentration and rubbing under force.

[0021] A method for fixing a rib plate fixator under thoracoscopic guidance includes the following steps: S1. Unfold and open the bone plate assembly 1 and the fixator assembly 2 in a 0~5℃ ice-water mixture; S2. The bone plate assembly 1 is moved to the side of the affected bone to be fixed. The fixed ring arm 101 is wrapped and contracted at 30-35°C to form a fixed ring end, thus fixing the bone plate assembly 1 to the affected bone. S3. Adjust the position of the fixator assembly 2, and use the circumferential arm 203 to circumferentially lock the bone fixation plate 103 and the affected bone, and at 30-35℃, perform a secondary fixation of the circumferential end in a shrinking shape. The circumferential arm 203 presses the anti-slip tooth assembly 104 tightly against the affected bone.

[0022] In steps S1 and S2, a laparoscopic tool is used to snap into the bone mounting hole 102 or mounting hole 202, and the laparoscopic tool moves the bone plate assembly 1 and the fixator assembly 2 to adjust their positions.

[0023] The bone plate assembly 1 is the main structure of the bone plate that fixes one side of the affected bone. The endoscopic tool can be the tool pliers head disclosed in our company's patent CN108403181A. The bone mounting hole 102 and the mounting hole 202 can be matched with the serrated circular mounting hole.

[0024] The bone plate assembly 1 and the fixator assembly 2 form a mechanical interlocking structure through the anti-slip tooth group 104, achieving separate fixation. During operation, the bone plate assembly 1 and the fixator assembly 2 are separately and sequentially fixed and assembled. Furthermore, the spacing between the two anti-slip teeth on the bone plate assembly 1 is larger than the width of the circumferential arm on the bone plate assembly 1, ensuring that the fixator assembly 2 will not detach from the bone plate assembly 1 during use. Therefore, a mechanical interlock can be formed when used together, preventing the product and components from detaching from the system.

[0025] The bone-setting plate assembly 1, including the bone-setting circumferential arm 101 and the bone-setting fixation plate 103, is manufactured in accordance with the human rib structure, enabling it to better fit the surface of the affected bone. The bone-setting circumferential arm 101 is curled along its open end to fit the cross-section of the rib, and the bone-setting fixation plate 103 can be designed according to different positions of the rib, with its curvature fitting the inner side of the rib.

[0026] The anti-slip tooth group 104 of the bone plate assembly 1 consists of multiple parallel tooth-like protrusions, used to form a mechanical interlock with the circumferential arm 203 of the fixator assembly 2. This structure utilizes the properties of shape memory alloy material, allowing the product to be in a clamping state during normal operation, thus precisely fitting with the U-shaped groove reserved in the bone plate assembly 1, and continuously providing circumferential force at body temperature. Compared with the existing screw-locking plate structure, this structure has the following characteristics: 1. The screw-locking plate structure will form stress concentration at the screw connection, increasing the risk of use. This structure avoids stress concentration by using a groove; 2. The screw-locking plate has many parts under thoracoscopy, and the fit is too precise, which poses a surgical difficulty. The groove structure has a significant surgical advantage over the screw-locking plate structure; 3. The fixator assembly 2 installed with this groove structure can move slightly within the groove, increasing the product's flexibility and reducing product fatigue caused by chest cavity fluctuations.

[0027] After restoring its shape, the circumferential arm 203 of the fixator assembly 2 will fit tightly against the bone fixation plate 103 of the bone plate assembly 1, and the inner side of the circumferential arm is located between the teeth of the anti-slip tooth group 104, forming a stable mechanical connection. This structure utilizes the inherent property memory of the material. Since the size of the circumferential arm of the product is slightly smaller than the size of the affected bone during selection, the product will fit tightly against the affected bone when installed. Relying on the material's restorative force, the two groups will interlock, resulting in a significant anti-slip and anti-dislodgement effect.

[0028] Using laparoscopic tools, connect the bone plate assembly 1 and move it to the affected side for initial fixation. During initial fixation, ensure that the center of the fixation plate 103 is at the fracture end, the bone-embracing arm 101 is tightly fitted with the rib, and the bone-embracing arm 101 of the bone plate assembly 1 is tightly engaged with one side of the fracture. The bone fixation plate 103 can move within a certain range. Adjust the position of the affected bone to the ideal alignment. Return both ends of the fractured bone to their pre-fracture positions. Using laparoscopic tools, connect the fixator assembly 2 and move it to the other side of the affected bone. Allow the fixator assembly 2 to recover its shape under body temperature, forming a mechanical interlock with the bone plate assembly 1 for fixation.

[0029] This invention is a rib fixator or bone plate for thoracoscopic surgery, requiring the simultaneous use of bone plate assembly 1 and fixator assembly 2 to achieve internal fixation of the affected bone. Both components are manufactured using nickel-titanium shape memory alloy material conforming to GB / T 24627, allowing the product's arm to open in an ice-water mixture at 0–5°C and return to its original shape at body temperature. The arm and fixation plate are both modeled after the structure of the human rib, ensuring a better fit to the affected bone.

[0030] In laparoscopic surgery, the bone plate assembly 1 and fixator assembly 2 are first placed in an ice-water mixture to open the retaining arm. Then, bone plate assembly 1 is connected to the laparoscopic tool. Using the laparoscopic tool, bone plate assembly 1 is moved into the patient's chest cavity, and the retaining arm is moved to one side of the affected bone for installation. After one side is stably installed, fixation is performed on that side. When installing the other side, the position of the affected bone can be adjusted until it is aligned. Then, assembly 2 is connected to the laparoscopic tool, and fixator assembly 2 is moved to the other side of the affected bone using the laparoscopic tool. Fixator assembly 2 is then used to connect the side of bone plate assembly 1 without the retaining arm to the affected bone, and fixator assembly 2 is placed between the anti-slip teeth. This installation method avoids the cumbersome steps of existing bone plates, which require aligning the affected bone first, and then removing the fixator, aligning the affected bone again, and then reinstalling it due to bone displacement during installation.

Claims

1. A thoracoscopic rib plate fixator, characterized in that, Includes a bone plate assembly (1) and a fixator assembly (2); the bone plate assembly (1) and the fixator assembly (2) are made of nickel-titanium shape memory alloy; the bone plate assembly (1) and the fixator assembly (2) expand and open in a 0-5℃ ice-water mixture, and the bone plate assembly (1) and the fixator assembly (2) shrink and encircle at 34-38℃; The bone plate assembly (1) includes a bone fixation plate (103), a bone circumferential arm (101), a bone mounting hole (102), and an anti-slip tooth assembly (104); the bone fixation plate (103) has a bone mounting hole (102), the circumferential arm (101) is located on one side of the fixation plate (103), and the anti-slip tooth assembly (104) is located on the other side of the fixation plate (103); The fastener assembly (2) includes a fixing plate (201), mounting holes (202) and a retaining arm (203); the fixing plate (201) has mounting holes (202); and retaining arms (203) are provided on both sides of the fixing plate (201). The fixation plate (201) of the fixator assembly (2) is attached to the bone fixation plate (103) of the bone plate assembly (1), and the circumferential arm (203) circumferentially locks the bone fixation plate (103).

2. The thoracoscopic rib plate fixator according to claim 1, characterized in that, The anti-slip tooth group (104) of the bone plate assembly (1) is composed of multiple parallel tooth-like protrusions. The anti-slip tooth group (104) is provided in multiple sets, and the multiple sets of anti-slip tooth groups (104) are arranged at intervals. The circumferential arm (203) is located at the gap between two adjacent sets of anti-slip tooth groups (104).

3. The thoracoscopic rib plate fixator according to claim 2, characterized in that, The anti-slip tooth group (104) of the bone plate assembly (1) is composed of multiple parallel tooth-like protrusions. There are two sets of anti-slip tooth groups (104), which are arranged at intervals. The circumferential arm (203) is located at the gap between the two sets of anti-slip tooth groups (104).

4. The thoracoscopic rib plate fixator according to claim 1, characterized in that, The bone plate assembly (1) and the fixator assembly (2) are interlocked and connected in a ring.

5. A thoracoscopic rib plate fixator according to claim 4, characterized in that, The bone plate assembly (1) and the fixator assembly (2) are arranged in a cross shape.

6. A thoracoscopic rib plate fixator according to claim 5, characterized in that, The bone fixation plate (103) of the bone plate assembly (1) is arc-shaped and fits against the rib.

7. A thoracoscopic rib plate fixator according to claim 6, characterized in that, The fixation plate (201) is in contact with the bone fixation plate (103), and the outer edge of the fixation plate (201) extends along the axial direction of the bone fixation plate (103).

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