Rib fracture fixing system

Abstract

The invention relates to a rib fracture fixing system in the field of medical instruments. The rib fracture fixing system comprises a thoracoscope, a guide needle, a polyether-ether-ketone suture anchor line and a low-temperature thermoplastic plate. The low-temperature thermoplastic plate is made of a thermoplastic material which is softened at the temperature of 60-90 DEG C and cooled and cured at the room temperature within 1.5-3 min, and a plurality of preset meshes are formed in a plate body. The polyether-ether-ketone suture anchor line is used for penetrating through rib tissue and fixing the low-temperature thermoplastic plate to the chest wall. The guide needle is used for guiding a polyether-ether-ketone suture anchor line to percutaneously penetrate in vitro and penetrate through the chest wall according to a specific path; the thoracoscope is used for guiding the puncture path of the guide needle. By means of the minimally invasive fixing system, accurate, firm and low-trauma fracture fixation can be achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a rib fracture fixation system. BACKGROUND

[0002] Rib fracture is a common type of injury in chest trauma, which is usually caused by external impact, extrusion, etc. If not properly treated or fixed, it is easy to cause complications such as hemothorax, pneumothorax, aggravated pulmonary contusion, flail chest, etc., and even endanger the patient's life in severe cases. At present, the treatment methods for rib fracture in clinical practice mainly include conservative treatment and surgical treatment.

[0003] The conservative treatment usually adopts chest band external fixation, elastic bandage, etc. The operation is relatively simple, but the fixation stability is poor, and it is difficult to effectively limit the displacement of the fracture end, especially for patients with multiple rib fractures or obvious displacement of the fracture end. The treatment effect is not good, and the recovery period of the patient is long. During the period, the patient is easy to cause severe pain due to coughing, turning over and other actions, affecting the recovery of respiratory function and increasing the risk of pulmonary infection.

[0004] Surgical treatment is currently the main means for treating severe rib fractures. Commonly used surgical fixation materials include bone plates, intramedullary nails, absorbable screws, etc. Among them, although the bone plate fixation can provide good stability, it has the problems of large surgical incision, heavy trauma, much bleeding during operation, slow postoperative recovery, etc. The intramedullary nail fixation is suitable for some types of rib fractures, but for patients with severe comminuted fracture ends or irregular rib shapes, the fixation effect is limited, and the implant needs to be removed again, increasing the pain and medical expenses of the patient. Although the absorbable material can avoid secondary surgery, it has the defects of mismatching between the degradation rate and the fracture healing rate, and the gradual decrease of the fixation strength with the degradation, etc., which is difficult to meet the fixation needs of complex fractures.

[0005] In recent years, the treatment concept of chest trauma has shifted to trauma control and enhanced recovery after surgery (ERAS). Minimally invasive rib fixation surgery (MIRFS) under thoracoscopy has become a development trend due to its small trauma and good vision. However, the existing fixation devices are difficult to adapt to such minimally invasive approach, and there is a lack of a fixation device that can be implanted through a small incision and achieve precise, firm and biocompatible fixation. SUMMARY

[0006] The present application aims to provide a rib fracture fixation system to achieve precise, firm and low-trauma fracture fixation.

[0007] To achieve the above-mentioned purpose, the present application adopts the following technical solution: a rib fracture fixation system, comprising a thoracoscope, a guide needle, a polyether ether ketone suture anchor wire and a low-temperature thermoplastic plate. The low-temperature thermoplastic plate is made of a thermoplastic material that softens at a temperature of 60-90℃ and solidifies at room temperature within 1.5-3 minutes, and a plurality of preset mesh holes are arranged on the plate body; The polyether ether ketone suture anchor line is used to pass through the rib tissue and fix the low-temperature thermoplastic plate to the chest wall. The guide needle is used to guide the polyether ether ketone suture anchor line to pass in from the outside of the body and pass through the chest wall along a specific path. The thoracoscope is used to guide the puncture path of the guide needle.

[0008] Preferably, as an improvement, the preset mesh holes are arranged in a matrix, the hole diameter is 1.5-3.0 mm, and the center distance between adjacent mesh holes is 5-10 mm.

[0009] Preferably, as an improvement, the rib fracture fixation system further comprises a steam treatment box, which comprises a sealed box body, a steam generation unit and a timing control module arranged in the box body. The steam generation unit generates and maintains saturated water vapor at 60-90℃. The timing control module sets the fumigation time to 3-5 minutes.

[0010] The use method of the rib fracture fixation system comprises the following steps: (1) Connect the polyether ether ketone suture anchor line to the guide needle, and pass the polyether ether ketone suture anchor line through the guide needle from the outside of the body under the guidance of the thoracoscope, penetrate the needle close to the upper edge of the adjacent rib below the fractured rib, and then penetrate the needle from the upper edge of the fractured rib and lead the needle out of the body through another intercostal space. (2) Place the low-temperature thermoplastic plate in hot steam at 60-80℃ for fumigation for 3-5 minutes to soften the plate. (3) After the low-temperature thermoplastic plate is softened, it is attached to the patient's chest to shape and cool and solidify. (4) Pass the polyether ether ketone suture anchor line led out of the body through the preset mesh holes on the low-temperature thermoplastic plate, and tie a knot outside the body to form a stable fixation between the low-temperature thermoplastic plate and the rib.

[0011] The beneficial effects of the present application are: 1. Minimally invasive and low trauma: The present application places the polyether ether ketone (PEEK) suture anchor line through the skin under the guidance of the thoracoscope, and combines the low-temperature thermoplastic plate shaped outside the body to avoid the extensive incision and exposure of the rib required by the traditional bone plate fixation, significantly reducing the surgical incision, tissue damage and intraoperative bleeding volume, and meeting the concept of enhanced recovery after surgery (ERAS).

[0012] 2. Precise fixation and good stability: The procedure is performed under direct thoracoscopy, which allows for precise control of the guide needle puncture path and ensures that the anchor thread passes through the anatomically safe area of ​​the fractured rib and its adjacent ribs. Combined with a low-temperature thermoplastic plate with a pre-set mesh structure, the fracture site is effectively compressed and stabilized by external knotting, which effectively limits the displacement of the fracture ends and promotes bone healing.

[0013] 3. Personalized fit and good conformability: The low-temperature thermoplastic plate has excellent plasticity after softening in steam at 60-90℃. It can closely conform to the individualized thoracic curvature of the patient. After cooling and solidification, it maintains its shape and provides uniform support, avoiding stress concentration or fixation failure caused by shape mismatch of traditional rigid bone plates.

[0014] 4. High biocompatibility and safety: The polyetheretherketone (PEEK) material used has excellent biocompatibility, corrosion resistance and mechanical properties, and there is no obvious rejection reaction after long-term implantation in the body; the low-temperature thermoplastic plate is also a medical-grade thermoplastic material, which is non-toxic and non-allergenic, and is suitable for long-term fixation of the chest wall.

[0015] 5. No need for secondary surgery to remove: Unlike metal bone plates or intramedullary nails, this system uses polymer materials that can be left in place for a long time, avoiding the pain and risks of secondary surgery to remove internal fixation, reducing the burden on patients and medical costs.

[0016] 6. Simple operation and suitable for minimally invasive approaches: The entire system has simplified components and standardized operating procedures, making it particularly suitable for minimally invasive rib fixation surgery (MIRFS) assisted by thoracoscopic surgery. It solves the technical bottleneck of existing fixation instruments that are difficult to implant through small incisions or cannot provide sufficient fixation strength.

[0017] 7. Reduced risk of complications: Due to the stable fixation, minimal trauma, and less pain, patients can move early after surgery and cough up sputum effectively, which significantly reduces the incidence of pulmonary complications such as atelectasis, pneumonia, and respiratory failure, and improves the overall prognosis. Attached Figure Description

[0018] Figure 1 This is a model diagram of a rib fracture fixation system. Detailed Implementation

[0019] The following detailed description illustrates the specific implementation method: 1. Materials and Methods 1.1 General Information Inclusion criteria: (1) Flail chest diagnosed by chest CT + bone 3D reconstruction (≥3 consecutive ribs with multiple fractures and chest wall floating); (2) Admission within 48 hours after injury; (3) Age 18-95 years; (4) Signed informed consent form.

[0020] Exclusion criteria: (1) Concurrent severe head, abdominal or limb injuries requiring simultaneous surgery; (2) Thoracic infection or history of thoracic surgery; (3) Pathological rib fractures (such as tumor metastasis or osteoporotic fractures); (4) Concurrent severe heart, liver or kidney dysfunction, coagulation disorders, systemic infectious diseases or malignant tumors; (5) Women who are pregnant or lactating.

[0021] Seventy patients meeting the above criteria were selected from July 2021 to December 2025 and randomly divided into three groups using a random number table. Group A (external fixation group, n=30): 18 males and 12 females; age 44-91 years, mean (68.5±10.2) years; causes of injury: traffic accidents (16 cases), falls from heights (8 cases), and impacts from heavy objects (6 cases); number of fractures: 3-6, mean (4.3±1.0) fractures. Group B (open reduction and internal fixation group, n=30): 19 males and 11 females; age 37-79 years, mean (58.6±9.5) years; causes of injury: traffic accidents (17 cases), falls from heights (7 cases), and impacts from heavy objects (6 cases); number of fractures: 3-7, mean (4.6±1.2) fractures. Group C (rib fracture fixation system group, n=10): 6 males and 4 females; age range 46-74 years, mean (64.3±8.5) years; cause of injury: traffic accidents (5 cases), falls from heights (3 cases), and impact from heavy objects (2 cases); number of fractures: 3-6, mean (4.5±1.1) fractures. There were no statistically significant differences among the three groups in terms of gender, age, cause of injury, and number of fractures (P>0.05), indicating comparability. This study has been approved by the Ethics Committee of Xishui County People's Hospital (Ethics Approval No.: 2025XRYLS).

[0022] 1.2 Treatment methods 1.2.1 Group A (External Thoracic Fixation Group) After successful local anesthesia, a closed thoracic drainage tube was inserted through the midaxillary line at the 6th-7th intercostal space to continuously drain pleural effusion / hemiplegia. This was combined with external fixation using a traditional multi-headed chest strap or chest brace. Simultaneously, symptomatic treatment including mechanical ventilation with positive pressure ventilation, intravenous analgesia, anti-infection medication, expectorants, and measures to promote fracture healing was administered. Early bed mobility was encouraged, and the patient was instructed on effective coughing and expectoration to prevent pulmonary infection. The drainage tube was removed once the pleural drainage volume was <50 ml / day and chest X-ray results were assessed.

[0023] 1.2.2 Group B (Open Reduction and Internal Fixation Group) Under general anesthesia, endotracheal intubation is performed, and the patient is placed in the lateral decubitus position on their healthy side. An incision of 8-12 cm in length is made according to the fracture site. The skin and subcutaneous tissue are incised layer by layer, and the chest wall muscles are dissected along the muscle texture to fully expose the fracture ends. Hematoma and necrotic tissue are cleaned, and the periosteum on both sides of the fracture ends is dissected 2-4 cm. After anatomical reduction, a matching shape memory alloy retainer is selected, placed in sterile ice water to open the retainer arms, and quickly fitted onto the fracture ends. Hot saline gauze is used for wet dressing to encourage the retainer to automatically tighten and fix. After confirming secure fixation, the muscles, subcutaneous tissue, and skin are sutured layer by layer. A closed chest drainage tube and a negative pressure drainage device are placed according to the specific condition of the thoracic cavity. Postoperatively, mechanical ventilation with positive pressure is provided, along with routine antibiotics for 3-5 days. Intensive pulmonary physical therapy is administered, and the patient is encouraged to ambulate early. The drainage tube is removed once the thoracic drainage volume is <50 ml / day and the chest X-ray results are assessed.

[0024] 1.2.3 Group C (rib fracture fixation system group) After endotracheal intubation and general anesthesia, the patient is placed in the lateral decubitus position on their healthy side. A 2cm incision is made in the 6th or 7th intercostal space along the midaxillary line. A protective sheath and thoracoscope are inserted to thoroughly explore lung tissue damage, hemothorax, fracture displacement, and active bleeding. If necessary, lung repair, pleural hemostasis, and debridement of the hemothorax are performed simultaneously. Under real-time thoracoscopic guidance, a guide needle is used to insert polyetheretherketone (PEEK) sutures through the skin, close to the upper edge of the rib below the fracture, and exits from the upper edge of the fractured rib, exiting through another intercostal space. A low-temperature thermoplastic plate is placed in a steam treatment box and softened by fuming with 60-90℃ hot steam for 3-5 minutes. After removal, it is quickly applied to the patient's chest wall and shaped, then cooled and solidified within 2 minutes. The sutures are then tied externally to the pre-set mesh of the thermoplastic plate. After confirming again via thoracoscopy that the fracture is securely fixed and there is no intercostal bleeding, a chest drainage tube is routinely placed, the incision is closed, and external fixation with a chest band is used for reinforcement. Postoperatively, patients are given positive pressure ventilation with a ventilator and routinely use antibiotics for 3-5 days. The drainage tube is removed after the amount of pleural drainage is <50ml / day and the chest X-ray results are evaluated.

[0025] 1.3 Observation Indicators (1) Perioperative indicators: intraoperative blood loss, operation time, chest drainage volume, time to extubation, time to get out of bed, length of hospital stay, and time to fracture healing; (2) Pain assessment: Visual analog scale (VAS)[5] was used to record pain scores before surgery and 1, 3 and 7 days after surgery (0 points for no pain, 10 points for severe pain); (3) Lung function and blood gas indicators: blood oxygen saturation (SpO2), arterial blood oxygen partial pressure (PaO2), and arterial blood carbon dioxide partial pressure (PaCO2) before surgery and 1 week after surgery; (4) Complications: the occurrence of complications such as pulmonary infection, pleural effusion, atelectasis, chest deformity, and incision infection was statistically analyzed; (5) Other indicators: excellent treatment rate, time required for removal of fixation device and operation difficulty (divided into easy, medium and difficult), and appearance satisfaction rate (divided into satisfactory, basically satisfactory and unsatisfactory).

[0026] 1.4 Efficacy Evaluation Criteria Excellent: No chest wall deformity or collapse, bilaterally symmetrical, X-ray shows good fracture alignment, normal respiratory function, and no pain symptoms; Good: Mild chest wall deformity or collapse, X-ray shows a few ribs displaced <2cm, mild respiratory dysfunction, and occasional dull pain; Poor: Rib displacement >2cm, significant pain and respiratory distress, and no improvement in chest wall collapse. Excellent / Good Rate = (Excellent + Good) / Total Number of Cases × 100%.

[0027] 1.5 Statistical Analysis Data analysis was performed using SPSS 20.0 statistical software. Quantitative data were expressed as mean ± standard deviation (x ± s), and comparisons between groups were performed using one-way ANOVA or independent samples t-test. Categorical data were expressed as number (percentage) [n (%)], and comparisons between groups were performed using χ². 2 The test was performed, with P < 0.05 considered statistically significant.

[0028] 2 Results 2.1 Comparison of perioperative indicators The operation time in group C was (1.01±0.31) h, significantly shorter than that in group B (1.45±0.22) h (t=5.287, P<0.05), but there was no statistically significant difference compared to group A (0.34±0.07) h (t=1.896, P>0.05). Intraoperative blood loss and chest drainage volume in group C were significantly lower than in group B (P<0.05), but there was no statistically significant difference compared to group A (P>0.05). The time to extubation, time to ambulation, and length of hospital stay in group C were significantly shorter than in the other two groups (P<0.05). There was no statistically significant difference in fracture healing time among the three groups (P>0.05). See Table 1 for details.

[0029] Table 1 Comparison of perioperative related indicators among the three groups of patients (x±s)

[0030] 2.2 Comparison of pain scores There were no statistically significant differences in VAS scores among the three groups before surgery (P>0.05); on postoperative days 1, 3, and 7, the VAS scores of group C were significantly lower than those of groups A and B (P<0.05), and the VAS scores of group B were lower than those of group A (P<0.05). See Table 2 for details.

[0031] Table 2 Comparison of VAS scores at different time points before and after surgery in the three groups of patients (x±s, points)

[0032] 2.3 Comparison of pulmonary function and blood gas parameters Preoperatively, there were no statistically significant differences in SpO2, PaO2, and PaCO2 among the three groups (P>0.05). One week postoperatively, SpO2 and PaO2 in group C were significantly higher than those in group A (P<0.05), while PaCO2 was significantly lower in group C than in group A (P<0.05). There were no statistically significant differences in the above indicators between group C and group B (P>0.05). See Table 3 for details.

[0033] Table 3 Comparison of pulmonary function and blood gas parameters of the three groups of patients before and 1 week after surgery (x±s)

[0034] 2.4 Comparison of complications, excellent treatment rate, and appearance satisfaction rate The overall complication rate in group C (10.0%) was significantly lower than that in group A (23.3%) and group B (50.0%) (χ²). 2 =8.752, P<0.05; there was no statistically significant difference in the incidence of single complications (pulmonary infection, pleural effusion, atelectasis) among the three groups (P>0.05). The excellent and good treatment rate was 100.0% in all three groups, and there was no statistically significant difference between the groups (P>0.05); the appearance satisfaction rate in group C (100.0%) was significantly higher than that in group A (90.0%) and group B (50.0%) (χ²). 2 =9.568, P<0.05). See Table 4 for details.

[0035] Table 4 Comparison of complication rates, excellent treatment rates, and appearance satisfaction rates among the three groups of patients [n (%)]

[0036] 3. Fixation effect of rib fracture fixation system 3.1 Rib fracture fixation system model A model diagram of a rib fracture fixation system is attached. Figure 1 As shown.

[0037] 3.2 Minimally Invasive and Precise: Collaborative Solutions to the Dilemmas of Traditional Surgical Procedures Using only a 2cm thoracoscopic incision, replacing the traditional 5-10cm incision of open surgery, intraoperative blood loss is significantly reduced (53.0±12.2 ml vs. 195.6±22.3 ml), and muscle stripping and rib periosteal damage are avoided. This method, combining preoperative musculoskeletal ultrasound localization with real-time intraoperative thoracoscopic guidance, achieves individualized and precise puncture and fixation, establishing an integrated model of minimally invasive exploration, precise reduction, and reliable fixation, significantly improving patient prognosis.

[0038] 3.3 Biomechanical optimization: From structural fixation to functional preservation The key to treating flail chest lies in restoring chest wall stability while preserving respiratory function to the maximum extent possible. Low-temperature thermoplastic plates, after being heated, conform to the shape of the chest wall and provide rigid support after curing, achieving "selective rib fixation." This stabilizes the floating chest wall while preserving its physiological mobility, avoiding the instability caused by traditional external fixation or the restriction of respiratory movement by internal fixation devices. In this application, Group C showed better SpO2 and PaO2 at 1 week post-operation than the traditional external fixation group, demonstrating this mechanism. Furthermore, precise fixation reduces micromovement at the fracture ends, and combined with minimally invasive procedures to protect the intercostal nerves, resulting in a significant reduction in postoperative VAS scores, promoting early cough and activity, and forming a virtuous cycle of "reliable fixation, reduced pain, and functional recovery," aligning with the enhanced recovery after surgery (ERAS) principle of prioritizing function.

[0039] 3.4 Enhanced security and expanded target audience In this application, the overall complication rate (10.0%) was significantly lower than that of the traditional group, attributed to several advantages: First, the minimally invasive thoracoscopic procedure reduces intrathoracic disturbance and lowers the risk of intrathoracic complications. The lower incidence of pleural effusion and pulmonary infection in group C in this application is consistent with this conclusion. Second, the thermoplastic plate external fixation avoids chronic inflammation caused by foreign body retention, eliminating the need for a second surgery to remove the internal fixation device, thus reducing patient suffering and financial burden. Third, intrathoracic injuries (such as lung repair and hemostasis) can be treated simultaneously during the procedure, overcoming the limitation of traditional external fixation that neglects intrathoracic lesions. In this application, the extubation time and hospital stay in group C were significantly shortened, further validating the safety and efficiency of this procedure.

[0040] 3.5 Technological Innovation and Clinical Applicability This application integrates "thoracoscopic visualization guidance" and "low-temperature thermoplastic plate individualized shaping," absorbing the advantages of minimally invasive and precise thoracoscopic surgery while also drawing on the biomechanical properties of novel fixation materials to form a unique treatment model. Its learning curve is gentle, easy to master, and conducive to promotion at the grassroots level; at the same time, it addresses the needs of precision medicine, providing a new treatment option for patients who refuse open surgery through preoperative ultrasound positioning and individualized shaping.

[0041] The above descriptions are merely embodiments of the present invention, and common knowledge such as specific technical solutions and / or characteristics are not described in detail here. It should be noted that those skilled in the art can make various modifications and improvements without departing from the technical solutions of the present invention, and these should also be considered within the scope of protection of the present invention. These modifications and improvements will not affect the effectiveness of the implementation of the present invention or the practicality of the patent. The scope of protection claimed in this application should be determined by the content of its claims, and the specific embodiments described in the specification can be used to interpret the content of the claims.

Claims

1. A rib fracture fixation system, characterized in that: This includes a thoracoscope, guide needle, polyetheretherketone (PEEK) suture anchors, and a low-temperature thermoplastic plate; The low-temperature thermoplastic board is made of a thermoplastic material that softens at 60-90°C and cools and solidifies at room temperature within 1.5-3 minutes, and the board has multiple pre-set mesh holes. The polyetheretherketone suture anchor is used to pass through the rib tissue and fix the low-temperature thermoplastic plate to the chest wall; The guide needle is used to guide the polyetheretherketone suture anchor suture through the skin from outside the body and through the chest wall along a specific path; The thoracoscope is used to guide the puncture path of the guide needle.

2. The rib fracture fixation system according to claim 1, characterized in that: The preset mesh is arranged in a matrix, with a mesh diameter of 1.5 to 3.0 mm and a center-to-center distance of 5 to 10 mm between adjacent meshes.

3. The rib fracture fixation system according to claim 2, characterized in that: It also includes a steam treatment box, which includes a sealed box body, a built-in steam generating unit and a timer control module. The steam generating unit generates and maintains saturated water vapor at 60-90°C, and the timer control module sets the fumigation time to 3-5 minutes.

4. The method of using the rib fracture fixation system according to any one of claims 1 to 3, characterized in that: Includes the following steps: (1) Connect the polyetheretherketone suture anchor to the guide needle. Under the guidance of thoracoscopy, the polyetheretherketone suture anchor is percutaneously inserted through the guide needle, and the needle is inserted close to the upper edge of the adjacent rib below the fractured rib. The needle is then exited from the upper edge of the fractured rib and out of the body through another intercostal space. (2) Place the low-temperature thermoplastic board in hot steam at 60-80℃ for 3-5 minutes to soften it; (3) The softened low-temperature thermoplastic board is fitted to the patient's chest and then cooled and solidified; (4) Pass the polyether ether ketone suture anchor thread that has been brought out of the body through the pre-set mesh on the low-temperature thermoplastic plate and tie it outside the body to form a stable fixation between the low-temperature thermoplastic plate and the rib.

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