A new pectus excavatum orthotic system

Abstract

The utility model provides a novel funnel chest orthopedic system, include: orthopedic subassembly and be used for overturning orthopedic subassembly's overturning subassembly, orthopedic subassembly includes orthopedic main part and be used for fixing orthopedic main part's fixed component, orthopedic main part is arc, orthopedic main part includes first end and with first end opposite second end, first end's width is less than second end's width, fixed component includes first fixed part and second fixed part, first fixed part with second fixed part all is provided with recess structure, first end passes recess structure of first fixed part, and first fixed part with first end passes detachable mode connection, second end passes recess structure of second fixed part, and second fixed part with second end passes detachable mode connection, the utility model discloses novel funnel chest orthopedic system is more small, operation is more simple, and security is higher.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a novel pectus excavatum correction system. Background Technology

[0002] Pectus excavatum (PE) is the most common congenital malformation of the anterior chest wall, characterized by a funnel-shaped depression of the sternum, costal cartilage, and part of the ribs towards the spine. Its etiology is complex, but mainstream research suggests it is primarily related to the following factors: congenital chest wall developmental abnormalities, excessive growth of the costal cartilage leading to posterior displacement of the sternum, shortening of the central tendon of the diaphragm pulling the lower sternum towards the spine, and nutritional and metabolic diseases (such as rickets).

[0003] This condition has a dual impact on patients, both physically and psychologically. Physiologically, the sunken sternum directly compresses the heart and lungs, leading to a decreased ejection fraction and reduced lung capacity. Although most patients' cardiopulmonary function indicators are still within the lower limit of the normal range at rest, their physiological potential is significantly impaired, manifesting as decreased exercise tolerance, fatigue, palpitations, and shortness of breath, severely restricting their quality of life and physical development. Psychologically, the abnormal appearance of the chest, especially for adolescents in their psychologically sensitive period, can easily trigger profound feelings of inferiority and anxiety, leading to social phobia and withdrawn personalities, casting a long-term negative shadow on their mental health. The clinical medical community agrees that all medications, physical exercises, or traction devices are ineffective in correcting the skeletal structure of pectus excavatum; surgery is the only treatment that can fundamentally correct the deformity and relieve organ compression.

[0004] Looking back at the history of surgical treatment for pectus excavatum, it has evolved from major incision to minimally invasive surgery:

[0005] First-generation surgery: Traditional sternal rotation surgery.

[0006] This was an early, representative surgical technique. Its core procedure involved extensively cutting the affected ribs and sternum, flipping the entire sunken bony structure as a whole, like turning a bowl upside down, and then fixing it with wire. While the intention was clear, this method was extremely invasive, almost equivalent to "disassembling and reconstructing" the ribcage. The surgery resulted in significant bleeding, was lengthy, and often yielded unsatisfactory corrective results, transforming the original sunken deformity into a jarring bulge. Aesthetic improvement was limited, and the incidence of postoperative complications was high. It has now been completely phased out.

[0007] Second-generation surgery: Long incision sternal elevation surgery (Ravitch procedure).

[0008] As an improvement on the first-generation surgery, the Ravitch procedure was once considered the gold standard. This procedure involves a long, midline incision in the sternum, removing multiple excessively long costal cartilages, and then, after a retrosternal osteotomy, implanting a metal support plate (such as a steel plate) to elevate the sternum, and reconnecting the bones with wires. Compared to sternal rotation surgery, its corrective concept is more rational. However, it is essentially still a major open surgery, causing significant trauma, disrupting the stability of the chest wall and the growth potential of the costal cartilage, resulting in slow postoperative recovery and leaving long and noticeable scars, causing secondary cosmetic trauma to patients.

[0009] Third-generation surgery: Nuss procedure for three-port pectus excavatum correction.

[0010] The Nuss procedure was a revolutionary breakthrough in the treatment of pectus excavatum, establishing its dominance in minimally invasive surgery. Its core concept is to bypass bone structures and, under thoracoscopic guidance, penetrate the potential space behind the sternum to implant a pre-bent orthotic plate that instantly lifts the sunken sternum. A standard Nuss procedure requires three small incisions on both sides of the patient's chest wall (usually two on the right and one on the left, with a total incision length of approximately 6 cm). During the procedure, a penetrating device is used to repeatedly and roughly penetrate the mediastinal tissue behind the sternum to create a tunnel, a process that carries the potential risk of damage to the heart, major blood vessels, and pericardium. The orthotic plate used is made of stainless steel with serrated edges. While this helps with fixation after implantation, it can severely tear and damage surrounding soft tissues during the penetration process and during removal surgery several years later. Furthermore, the orthotic plate is manufactured as a straight plate and must be manually bent by the surgeon during the operation based on experience. The accuracy of the shape and its fit to the individual's chest is difficult to guarantee, directly affecting the corrective effect. Stainless steel not only has poor biocompatibility, easily triggering rejection or allergies, but also prevents patients from undergoing important medical examinations such as MRI after surgery, posing a risk to future health management. Although it is called "minimally invasive," the characteristics of three incisions, repeated punctures, and serrated steel plates mean that its trauma should not be underestimated.

[0011] Currently, while the mainstream third-generation Nuss procedure represents a significant leap forward compared to the previous two generations, its technical system still has the following pain points that urgently need to be addressed:

[0012] Insufficient controllability of trauma: Three incisions and repeated retrosternal punctures result in cumulative trauma to muscles, nerves and soft tissues, leading to significant postoperative pain and a longer recovery period.

[0013] The surgical procedure is complex and relies heavily on experience: the manual bending of the steel plate introduces a great deal of uncertainty. Whether the curvature of the orthotic plate matches the patient's physiological chest wall depends heavily on the surgeon's personal experience and feel. The low degree of standardization affects the uniformity and reliability of the surgical results.

[0014] Aesthetic and psychological well-being are lacking: The three scars left on both sides of the chest wall are still a psychological burden for patients who seek treatment for cosmetic reasons.

[0015] Existing pectus excavatum correction devices, especially the widely used third-generation Nuss procedure, still have many shortcomings in terms of trauma control, surgical simplification, implant biocompatibility, and long-term safety. Therefore, there is an urgent clinical need for a new orthopedic system that is less invasive, easier to operate, safer, and has better corrective effects to overcome the deficiencies of existing technologies. Utility Model Content

[0016] The purpose of this invention is to provide a novel pectus excavatum correction system. Based on this device, surgery can achieve a single incision, minimize trauma, reduce intraoperative bleeding and tissue damage, thereby effectively reducing surgical complications, promoting rapid patient recovery, and simplifying postoperative care procedures.

[0017] The first aspect of this utility model provides a novel pectus excavatum correction system, comprising:

[0018] Orthopedic assembly and a flipping assembly for flipping the orthopedic assembly;

[0019] The orthopedic assembly includes an orthopedic body and a fixing assembly for fixing the orthopedic body;

[0020] The orthopedic body is arc-shaped, and includes a first end and a second end opposite to the first end; the width of the first end is smaller than the width of the second end;

[0021] The fixing component includes a first fixing member and a second fixing member;

[0022] Both the first and second fixing members are provided with groove structures;

[0023] The first end passes through the groove structure of the first fixing member, and the first fixing member is detachably connected to the first end;

[0024] The second end passes through the groove structure of the second fixing member, and the second fixing member is detachably connected to the second end.

[0025] According to this utility model, in some embodiments, the orthopedic body is made of titanium alloy.

[0026] According to this utility model, in some embodiments, the width of the groove structure is greater than or equal to the width of the orthopedic body.

[0027] According to this utility model, in some embodiments, the first fixing member is connected to the first end by means of screws.

[0028] According to this utility model, in some embodiments, the second fixing member is connected to the second end by means of screws.

[0029] According to this utility model, in some embodiments, the first fixing member and the second fixing member are respectively placed on both sides of the orthopedic body; the first fixing member is placed on the upper side of the orthopedic body and the second fixing member is placed on the lower side of the orthopedic body; or the second fixing member is placed on the upper side of the orthopedic body and the first fixing member is placed on the lower side of the orthopedic body.

[0030] According to this utility model, in some embodiments, the flipping assembly includes a handle assembly, a clamping assembly, and a fixing screw; the handle assembly is a T-shaped structure, including a horizontal handle structure and a through-hole structure perpendicular to the horizontal handle structure; the clamping assembly is connected to the through-hole structure; the clamping assembly is used to clamp the orthopedic body; the fixing assembly is screwed into the through-hole structure and uses the fixing screw to hold the orthopedic body in place.

[0031] According to this utility model, in some embodiments, the novel pectus excavatum correction system further includes a shaping device, which can shape the correction body into the desired shape according to the patient's chest shape.

[0032] According to this utility model, in some embodiments, the novel pectus excavatum correction system further includes a thoracoscopic cannula, which can establish a passage for the correction components.

[0033] This invention, through a single-incision design, successfully reduces the number of incisions to 1-2, resulting in less postoperative pain, less intraoperative bleeding, and significantly smaller surgical scars. Clinical results show that patients experience shorter postoperative recovery periods and correspondingly shorter hospital stays, greatly satisfying patients' urgent needs for cosmetic improvement and rapid recovery.

[0034] The flipping assembly of this invention significantly reduces the surgeon's over-reliance on personal experience and touch during surgery. When the orthotic body is flipped using the flipping assembly, the T-shaped structure essentially constitutes a highly efficient lever system. When the critical flipping action of the orthotic body 11 needs to be performed, the force applied by the surgeon to both ends of the T-shaped handle is transmitted along the handle and generates a torsional torque that is much greater than that of directly rotating the straight rod. This allows the surgeon to complete a stable 180° flip of the orthotic body within the chest cavity with relatively little hand force. Attached Figure Description

[0035] Figure 1 This is a schematic diagram of the overall orthopedic components;

[0036] Figure 2 This is a schematic diagram of the overall flip component;

[0037] Figure 3 This is an overall schematic diagram of the fixed components;

[0038] Figure 4 This is a schematic diagram of the overall assembly of the flip-up component. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of this disclosure clearer, the technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. The same reference numerals in the drawings represent the same components. It should be noted that the described embodiments are only some, not all, of the embodiments of this disclosure. All other embodiments obtained by those skilled in the art based on the described embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

[0040] Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this utility model pertains. The terms "first," "second," and similar words used in this utility model patent application specification and claims do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as "comprising" or "including" mean that the element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, without excluding other elements or objects. Terms such as "inner," "outer," "upper," "lower," "far," "near," "front," and "rear" are used only to indicate relative positional relationships; when the absolute position of the described object changes, the relative positional relationship may also change accordingly. The accompanying drawings described in this disclosure are merely structural schematic diagrams.

[0041] This utility model discloses a novel pectus excavatum correction system, such as Figures 1 to 3 As shown, it includes:

[0042] Orthopedic component 1 and flipping component 2 for flipping the orthopedic component;

[0043] The orthopedic assembly 1 includes an orthopedic body 11 and a fixing assembly 12 for fixing the orthopedic body;

[0044] The orthotic body 11 is made of high-strength, biocompatible medical-grade stainless steel or titanium alloy. Under the assistance of thoracoscopy, the orthotic body 11 is passed behind the sternum, flipped, and then the depressed sternum is lifted using the lever principle to restore the normal shape of the thoracic cavity.

[0045] In a preferred embodiment, the orthopedic body 11 is made of titanium alloy. Examples of suitable products include: Ti-6Al-4V ELI, Ti-6Al-4V, Ti-6Al-7Nb, β-type titanium alloy, etc.

[0046] The orthopedic body 11 has an arc-shaped structure, and different lengths and curvatures of the orthopedic body 11 can be selected according to the patient's age, gender and degree of deformity.

[0047] In a preferred embodiment, the orthopedic body 11 includes a first end 111 and a second end 112 opposite to the first end; the width of the first end 111 is smaller than the width of the second end 112. Figure 1 As shown, the first end 111 and the second end 112 are not symmetrical structures. The width of the first end 111 is smaller than the width of the second end 112. Its function is, on the one hand, to facilitate the orthopedic body 11 to pass through the sternum; the rounded and pointed structure at the front end will reduce the resistance of the orthopedic body 11 passing through the sternum.

[0048] The fixation assembly includes a first fixator 121 and a second fixator 122; the fixation assembly is used to fix the orthopedic body 11 to the ribs. After the orthopedic body 11 is flipped and the sternum is lifted, the two ends of the orthopedic body 11 become new mechanical fulcrums.

[0049] Both the first fixing member 121 and the second fixing member 122 are provided with groove structures;

[0050] The first end 111 passes through the groove structure 1211 of the first fixing member 121, and the first fixing member 121 is detachably connected to the first end 111.

[0051] The second end 112 passes through the groove structure 1221 of the second fixing member 122, and the second fixing member 122 is detachably connected to the second end 112.

[0052] Detachable connection methods include: screw connection, snap-fit ​​connection, magnetic connection, hook / slot connection, etc.

[0053] In a preferred embodiment, the first fastener 121 is connected to the first end 111 by a screw.

[0054] In a preferred embodiment, the second fastener 122 is connected to the second end 112 by a screw.

[0055] In a preferred embodiment, the first fixing member 121 and the second fixing member 122 are respectively placed on both sides of the orthopedic body 11. Figure 1(Not shown).

[0056] In a preferred embodiment, the first fastener 121 is positioned on the upper side of the orthopedic body 11, and the second fastener 122 is positioned on the lower side of the orthopedic body 11.

[0057] In another preferred embodiment, the second fastener 122 is positioned on the upper side of the orthopedic body 11, and the first fastener 121 is positioned on the lower side of the orthopedic body 11.

[0058] The present invention places the first fixing member 121 and the second fixing member 122 on both sides of the orthopedic body 11, transforming the orthopedic body 11, ribs, and fixing components into a stable "triangular truss" structure. The force is distributed to the upper and lower ribs, and the shear stress borne by a single rib is reduced by more than 40%, thereby preventing the steel plate from sinking or "cutting" the intercostal muscles.

[0059] like Figure 2 As shown, in another preferred embodiment, the flipping assembly 2 includes a handle assembly 21, a clamping assembly 22, and a fixing screw 3. The handle assembly 21 has a T-shaped structure. This T-shape facilitates hand operation by the surgeon and effectively prevents the instrument from slipping or rotating during force application, ensuring absolute precision even in surgical environments stained with blood or bodily fluids, thus improving surgical safety. Furthermore, when the flipping assembly 2 is used to flip the orthotic body 11, the T-shaped structure essentially constitutes a highly efficient lever system. When the critical flipping action of the orthotic body 11 needs to be performed, the force applied by the surgeon to both ends of the T-shaped handle is transmitted along the handle and generates a torsional torque much greater than that of directly rotating the straight rod. This allows the surgeon to complete a stable 180° flip of the orthotic body 11 within the chest cavity with relatively little hand force.

[0060] The handle assembly 21 includes a horizontal handle structure and a through-hole structure 23 perpendicular to the horizontal handle structure; the through-hole structure 23 has a through-hole channel 24 inside. Figure 3 As shown, the fixing screw 3 passes through the through hole channel 24 from top to bottom, and its lower end is connected to the threaded screw of the clamping assembly 22. Tightening the fixing screw 3 can drive it to move axially, thereby applying a clamping force to the orthopedic body 11 housed in the groove of the clamping assembly 22, thus locking the orthopedic body 11.

[0061] In a preferred embodiment, the novel pectus excavatum correction system further includes a shaper that can shape the orthopedic body into the desired shape according to the patient's chest shape.

[0062] The shaping device can be independently driven and locked, thereby collectively defining a three-dimensional contoured surface that conforms to the patient's target chest shape. The orthotic body 11 can be placed on this three-dimensional contoured surface and plastically deformed by applying external force, thereby being precisely shaped into the desired form. The shaping device is commercially available.

[0063] In a preferred embodiment, the novel pectus excavatum correction system further includes a thoracoscopic cannula, which can establish access for the correction components.

[0064] The thoracoscopic cannula enables coaxial real-time visualization throughout the entire implantation process of the orthopedic components, transforming the previously "semi-blind" operation into a fully visible one, fundamentally reducing the risk of injury. The thoracoscopic cannula was obtained commercially.

[0065] The method of using the novel pectus excavatum correction system of this utility model specifically includes the following steps:

[0066] S1. Measure the patient’s chest length to fit the orthopedic components, and mark the lowest point of the sternal indentation and the highest points on both sides of the funnel on the body surface.

[0067] S2. Place the orthopedic component on the surface of the thorax and check whether its curvature and length match; if the curvature does not match, shape the orthopedic body into the required shape according to the patient's thorax shape.

[0068] S3. Assemble the clamping component of the flipping component onto the orthopedic body, screw in the connecting screw, and confirm that the screw hole of the orthopedic body has been sealed by the sealing screw.

[0069] S4. Make a single incision of 2cm length at the anterior axillary line of the right chest wall; insert the thoracoscope cannula through the incision, guide the thoracoscope in and then remove the cannula, and then insert the assembled orthopedic component through the same incision.

[0070] S5. Under direct thoracoscopic guidance, the perforating end of the orthopedic component is passed through the retrosternal space until it penetrates the bone or muscle layer at the highest point marked on the left side and reaches the subcutaneous tissue.

[0071] S6. Remove the thoracoscope, use the flipping assembly to flip the orthopedic body 180° so that its arched side lifts the concave sternum, then unscrew the connecting screw and remove the flipping assembly;

[0072] S7. Place fixation components at the two ends of the orthopedic body where they contact the chest wall, and fix the orthopedic body and fixation components with bone screws. The first end of the orthopedic body passes through the groove structure of the first fixation member, and the first fixation member is connected to the first end by screws. The second end of the orthopedic body passes through the groove structure of the second fixation member, and the second fixation member is connected to the second end by screws. The fixation holes on both sides of the fixation component are sutured and fixed to the bone or muscle layer by medical steel wire.

[0073] The above-described method of use provided by this utility model has brought about significant technological progress in clinical applications.

[0074] First, it achieves precision and personalization in preoperative planning. Through precise measurement of thoracic length and surface marking of key anatomical landmarks in step S1, combined with the placement of the orthopedic component on the thoracic surface for curvature detection and adaptive shaping in step S2, this method ensures that the orthopedic component achieves a high degree of conformity with the patient's three-dimensional thoracic anatomy before implantation. This step overcomes the biases caused by traditional intraoperative reliance on experience-based estimations, laying a scientific biomechanical foundation for achieving the ideal postoperative thoracic morphology and significantly improving the symmetry and aesthetics of the orthodontic procedure.

[0075] Secondly, this method achieves an extremely minimally invasive surgical incision and a highly efficient integration of the operative pathway. A significant advantage of this approach is that, according to step S4, a single micro-incision is made in the unilateral chest wall, and thoracoscopic exploration and orthotic component implantation are performed sequentially through this same pathway. Compared to the multiple incisions required by traditional surgical procedures, this design greatly reduces the number and total length of surface trauma. This not only meets the aesthetic requirements of modern surgery but also directly reduces the risk of postoperative incision-related complications, alleviates patient pain, and accelerates the postoperative recovery process.

[0076] Furthermore, it ensures absolute safety and visibility of core operational steps. Step S5 explicitly requires the puncture of the retrosternal space under direct thoracoscopic guidance. This design places the path of the orthopedic components under real-time, coaxial visual monitoring, enabling the surgeon to clearly identify and proactively avoid critical organs such as the heart and major blood vessels. This visualization mechanism fundamentally solves the uncontrollable risks inherent in traditional blind procedures, elevating surgical safety to a new level.

[0077] Finally, a long-term stable mechanical fixation system was constructed. The fixation scheme employed in step S7, which utilizes bone screws to achieve a rigid connection between the orthotic body and the fixation components, supplemented by medical wires to anchor the fixation components to the bone or muscle layer, together forms a robust dual fixation system. This structure effectively resists the cyclical stresses generated by breathing and daily activities, minimizing the risk of long-term complications such as postoperative displacement or rotation of the orthotic body, thus providing a reliable mechanical environment for the thoracic cage to complete bony remodeling in the predetermined position.

[0078] The above are merely specific embodiments of this disclosure, but the scope of protection of this disclosure is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this disclosure should be included within the scope of protection of this disclosure. Therefore, the scope of protection of this disclosure should be determined by the scope of the claims.

Claims

1. A new pectus excavatum orthotic system characterized in that, include: Orthopedic assembly and a flipping assembly for flipping the orthopedic assembly; The orthopedic assembly includes an orthopedic body and a fixing assembly for fixing the orthopedic body; The orthopedic body is arc-shaped, and includes a first end and a second end opposite to the first end; the width of the first end is smaller than the width of the second end; The fixing component includes a first fixing member and a second fixing member; Both the first and second fixing members are provided with groove structures; The first end passes through the groove structure of the first fixing member, and the first fixing member is detachably connected to the first end; The second end passes through the groove structure of the second fixing member, and the second fixing member is detachably connected to the second end.

2. The novel pectus excavatum correction system according to claim 1, characterized in that, The orthopedic body is made of titanium alloy.

3. The novel pectus excavatum correction system according to claim 1, characterized in that, The width of the groove structure is greater than or equal to the width of the orthopedic body.

4. The novel pectus excavatum correction system according to claim 1, characterized in that, The first fastener is connected to the first end by a screw.

5. The novel pectus excavatum correction system according to claim 1, characterized in that, The second fastener is connected to the second end by a screw.

6. The new pectus deformity correction system according to claim 1, wherein, The first fixing member and the second fixing member are respectively placed on both sides of the orthopedic body; the first fixing member is placed on the upper side of the orthopedic body and the second fixing member is placed on the lower side of the orthopedic body; or the second fixing member is placed on the upper side of the orthopedic body and the first fixing member is placed on the lower side of the orthopedic body.

7. The new pectus deformity correction system according to claim 1, wherein, The flipping assembly includes a handle assembly, a clamping assembly, and a fixing screw; the handle assembly has a T-shaped structure, including a horizontal handle structure and a through-hole structure perpendicular to the horizontal handle structure; the clamping assembly is connected to the through-hole structure; the clamping assembly is used to clamp the orthopedic body; the fixing assembly is screwed into the fixing screw through the through-hole structure to hold the orthopedic body in place.

8. The new pectus deformity correction system according to claim 1, wherein, The novel pectus excavatum correction system also includes a shaper that can shape the corrective body into the desired shape according to the patient's chest shape.

9. The novel pectus excavatum correction system according to claim 1, characterized in that, The novel pectus excavatum correction system also includes a thoracoscopic cannula, which can create a pathway for the correction components.

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