3D (three-dimensional) printing surgical device for repairing osteochondral injury of talus

Abstract

The invention discloses a 3D printing surgical device used for talus osteochondral injury repair. The 3D printing surgical device comprises a fixing piece, a connecting piece and a guide channel. The fixing piece is of a curved surface sheet structure and comprises a left fixing piece body and a right fixing piece body which are symmetrical. The connecting piece is connected with the left fixing piece and the right fixing piece; the guide channel extends outwards from the center point of the focus part along the inner surface of the fixing piece and protrudes out of the outer surface of the fixing piece. The 3D printing surgical device can ensure that ideal positions and angles can be obtained at a time, repeated X-ray radiation exposure is avoided, and surgical time is saved; a plurality of repair and reconstruction paths can be flexibly arranged; the surgical precision is not influenced by limb movement, the operation is simple and convenient, and the cost is low.

Description

Technical Field

[0001] The present invention relates to the technical field of 3D printing, and in particular to a 3D printing surgical device for repairing talus osteochondral damage. Background Art

[0002] Osteochondral Lesions of the Talus (OLT) is a common bone and joint disease with a high incidence rate. It is often seen in various violent injuries involving the tibiotalar joint surface, such as ankle sprains and impacts. Osteochondral lesions of the talus are often accompanied by ankle swelling, pain, and limited joint movement, which will seriously affect the patient's ability to move and take care of themselves, causing great harm.

[0003] There are various treatments for osteochondral injuries of the talus, including conservative treatment and surgical treatment. Conservative treatment usually includes nonsteroidal anti-inflammatory drugs, physical rehabilitation therapy, etc., but it can only relieve symptoms in the short term and cannot fundamentally solve the problem. When conservative treatment is ineffective, surgical treatment becomes the main means to improve symptoms and restore joint function. Arthroscopic surgery is less invasive and has a quick recovery. It is one of the main surgical methods for OLT. The surgeon constructs a surgical channel from the skin to the ankle joint cavity through the area around the ankle joint with the help of arthroscopic instruments, and repairs the lesion under direct vision. Accurate positioning and complete reconstruction are the core principles of OLT repair surgery. Based on the above principles, arthroscopic surgery provides the surgeon with the technical means to intuitively observe the surface of the talus in the ankle joint, and can be operated with a variety of instruments including probes and scrapers.

[0004] However, in actual clinical practice, traditional arthroscopic OLT repair surgery still faces many limitations. The main reasons are: (1) It is difficult to locate the lesion. During arthroscopic surgery, the surgeon can only observe the cartilage surface of the talar dome, but cannot directly detect the location, structure and range of the lesion inside the bone. For lesions that have not undergone obvious degeneration on the cartilage surface and cannot be directly identified by appearance changes or probing with a probe hook, it is difficult to accurately determine the lesion area, which requires high surgeon experience. In addition, frequent use of X-rays for intraoperative positioning will also increase the patient's radiation exposure. (2) The operation is complex and costly. Arthroscopic surgery requires a large number of devices, and the preoperative preparation process is complicated. During the operation, the surgeon and related auxiliary personnel are required to have a high degree of operation and equipment coordination. The cost of equipment loss and consumables consumption in arthroscopic surgery is high, which brings a heavy medical economic burden. (3) Limb movement has a great impact on surgical errors. Movement of the ankle joint can cause relative displacement of the tibia and talus articular surfaces. In particular, plantar flexion and dorsiflexion can lead to large-scale changes in the exposed area of ​​the talar dome in the field of view. This causes more displacement interference and increased errors when the surgeon calculates the location of the lesion area based on the relative distance of the surrounding anatomical landmarks during surgery. (4) It is relatively difficult to implement multi-angle repair and reconstruction. The arthroscopic channel is relatively fixed, and the surgeon needs to complete the positioning, cleaning and repair of the lesion under the field of view of the channel. For deep and offset lesions, it is inconvenient to locate and repair from a single perspective. Increasing the number of channels will bring additional surgical operations, which not only increases the complexity of instrument coordination, but also prolongs the operation time. Summary of the invention

[0005] The purpose of the present invention is to overcome the problems existing in arthroscopic OLT repair surgery, such as high difficulty in lesion positioning, difficulty in multi-angle repair and reconstruction, and large surgical errors, and to provide a 3D printed surgical device that can be customized according to the patient's ankle joint CT three-dimensional reconstruction structure and can guide the percutaneous closed repair of talar osteochondral injuries.

[0006] In order to achieve the above-mentioned object, the present invention provides a 3D printed surgical device for repairing talar osteochondral damage, comprising a fixing member, a connecting member, and a guide channel;

[0007] The fixing member is a curved sheet structure, and the fixing member includes a symmetrical left fixing member and a right fixing member;

[0008] The connecting member connects the left fixing member and the right fixing member;

[0009] The guide channel extends outward from the center point of the lesion site along the inner surface of the fixing member and protrudes from the outer surface of the fixing member.

[0010] Optionally, the number of the guide channels is greater than or equal to 1.

[0011] Optionally, the guide channel is arranged to be away from an edge position of an outer surface of the fixing member.

[0012] Optionally, the guide channel has an inner diameter of 3mm-5mm, an outer diameter of 7mm-12mm, and a length of 35mm-65mm.

[0013] Optionally, the guide channel is used to insert a guide needle to treat the lesion site.

[0014] Optionally, the outer surfaces of the left fixing member and the right fixing member are respectively provided with a plurality of left through-hole members and right through-hole members, the left through-hole members and the right through-hole members are symmetrical to each other and protrude from the outer surfaces of the left fixing member and the right fixing member, and the protruding length of the left through-hole members and the right through-hole members is 10mm-25mm; the left through-hole members and the right through-hole members correspond to each other and match to form through-hole members.

[0015] Optionally, the left through hole member and the right through hole member are respectively provided with through holes which are symmetrical to each other, and the diameter of the through holes is 5mm-10mm.

[0016] Optionally, the connecting member passes through the through holes on the left through-hole member and the right through-hole member to connect the left fixing member and the right fixing member.

[0017] Optionally, the connecting piece is any one of a bolt, a pin, and a rivet.

[0018] Optionally, the fixing member is made by 3D printing.

[0019] Compared with the prior art, the technical solution of the present invention has at least the following beneficial effects:

[0020] 1) The lesion location is easy to locate. The surgical device accurately designs the fixing parts according to the patient's CT three-dimensional reconstructed skin morphology, and accurately places them by fitting them to the surface around the patient's ankle. It also uses a guide channel specially designed according to the fixing parts and the lesion location to guide the precise positioning of the lesion, ensuring that the ideal position and angle are obtained in one go, which not only avoids repeated X-ray radiation exposure, but also saves surgical time;

[0021] 2) Multiple repair and reconstruction pathways can be flexibly set. During the structural design stage, the surgical device can flexibly design multiple guide channels to guide the position and angle of the repair and reconstruction pathway according to the patient's bones, body surface morphology and surgical needs, so that the surgeon can perform multi-position and multi-directional puncture and repair operations, thereby quickly achieving multi-angle repair and reconstruction;

[0022] 3) The accuracy of the surgery is not affected by limb movement. The surgical device fully surrounds and fixes all surface structures from the lower leg to the front of the sole, preventing the influence of limb movement during surgical operations such as positioning and repair;

[0023] 4) Easy to operate and low cost. The entire process of using the surgical device is a surface operation without entering the body. The intraoperative installation process does not require complicated film reading and position calculation, nor does it require the use of arthroscopy, surgical navigators and other equipment. The surgical device can be produced using general precision resin 3D printing equipment, and the structural design process is standardized and process-based, with low requirements for equipment, materials and labor costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 These are the side view, top view, front view and three-axis view of the left fixing member and the right fixing member of the present invention; wherein a is the left fixing member and b is the right fixing member.

[0025] Figure 2 It is a schematic structural diagram of the assembly of the left fixing member and the right fixing member of the present invention; wherein a is a front view and b is a front triaxial view.

[0026] Figure 3 It is a schematic diagram of the structure of the left fixing member and the right fixing member of the present invention fitting with the patient's ankle; wherein a is a front view and b is a positive triaxial view.

[0027] Figure 4 It is a structural schematic diagram of a connecting piece of the present invention connecting a left fixing piece and a right fixing piece.

[0028] Figure 5 It is a structural schematic diagram of inserting a guide needle into the guide channel of the present invention.

[0029] Figure 6 It is a 3D image of a patient's foot and ankle and a schematic diagram of the use of the 3D printing surgical device of the present invention; wherein a is a 3D image of a patient's foot and ankle, and b, c, and d are schematic diagrams of the use of the 3D printing surgical device.

[0030] Figure ID:

[0031] Left fixing 1

[0032] Right fixing 2

[0033] Guide channel 11

[0034] Guide channel 21

[0035] First connecting piece 3

[0036] First through-hole member 31

[0037] First left through hole member 31a

[0038] First right through-hole member 31b

[0039] Second connecting piece 4

[0040] The second through hole member 41

[0041] The second left through hole member 41a

[0042] Second right through-hole member 41b

[0043] The third connecting piece 5

[0044] The third through hole member 51

[0045] The third left through-hole member 51a

[0046] The third right through-hole member 51b

[0047] Guide needle 6

[0048] Talus osteochondral7. DETAILED DESCRIPTION

[0049] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0050] In the description of the present invention, it should be noted that the terms "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0051] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0052] In traditional arthroscopic surgery, the surgeon can only observe the cartilage surface of the talar dome, but cannot directly detect the location, structure and range of the lesion inside the bone, making it difficult to accurately determine the lesion area. Secondly, arthroscopic surgery requires a large number of devices, and the preoperative preparation process is complicated, resulting in high equipment loss and consumables costs. In addition, ankle joint movement can cause relative displacement of the tibia and talus articular surfaces, resulting in more displacement interference and increased errors when calculating the position of the lesion area during surgery. On the other hand, the arthroscopic channel is relatively fixed. For deep and offset lesions, it is relatively difficult for the surgeon to locate, clean and repair the lesion under the field of view of the channel.

[0053] In order to solve the above problems, the present invention designs a 3D printed surgical device for repairing osteochondral damage of the talus. The surgical device accurately designs a fixing according to the skin morphology of the patient's CT three-dimensional reconstruction, and uses a guide channel specially designed according to the fixing and the lesion site to guide the precise positioning of the lesion, which can ensure that the ideal position and angle are obtained at one time, which not only avoids repeated X-ray radiation exposure, but also saves operation time; the operation does not require cutting the skin to observe the bones or inserting an arthroscope to observe the bones, which greatly simplifies the surgical process; in addition, the surgical device can flexibly design multiple guide channels according to the patient's bones, body surface morphology and surgical needs to achieve multi-angle repair and reconstruction; and the surgical device is easy to operate, low cost, and is not affected by limb movement. The 3D printed surgical device includes a fixing, a connecting piece, and a guide channel. The fixing is connected by a connecting piece, and the guide channel protrudes from the outer surface of the fixing, which is described in detail below.

[0054] like Figure 1 As shown, the fixing member includes a symmetrically arranged left fixing member 1 and a right fixing member 2. The left fixing member 1 and the right fixing member 2 are both curved sheet structures, with the same shape and size and symmetrical structure. They are precisely designed according to the surface morphology of the patient's foot and ankle, and are adapted to the surface morphology of the patient's foot and ankle. The left fixing member 1 and the right fixing member 2 can be quickly and accurately assembled into a whole (see Figure 2 In addition, holes are evenly distributed on the left fixing member 1 and the right fixing member 2 during design, which is used to reduce the weight of the fixing member so as to facilitate the patient to wear it. In actual use, the left fixing member 1 and the right fixing member 2 are respectively attached to the left and right sides of the patient's ankle, and then closed to form an integral shell that fits around the ankle joint (see Figure 3 ) to prevent the impact of limb movement during surgical operations such as positioning and repair.

[0055] like Figure 4As shown, a plurality of through-hole members can be respectively provided on the front, back and bottom surfaces of the left fixing member 1 and the right fixing member 2, and the through-hole members protrude from the outer surface of the fixing member, and the protruding length thereof is 10 mm-25 mm. It can be understood that the above-mentioned front, back and bottom surfaces refer to the front, back and bottom surfaces determined according to the patient's ankle after the left fixing member 1 and the right fixing member 2 are respectively attached to the left and right sides of the patient's ankle. As an example, in this embodiment, a first left through-hole member 31a and a first right through-hole member 31b are respectively arranged on the front sides of the left fixing member 1 and the right fixing member 2, the first left through-hole member 31a and the first right through-hole member 31b are symmetrical, and when the left fixing member 1 and the right fixing member 2 wrap the patient's ankle, they can be combined to form the first through-hole member 31; a second left through-hole member 41a and a second right through-hole member 41b are respectively arranged on the back sides of the left fixing member 1 and the right fixing member 2, the second left through-hole member 41a and the second right through-hole member 41b are symmetrical, and when the left fixing member 1 and the right fixing member 2 wrap the patient's ankle, they can be combined to form the second through-hole member 41; a third left through-hole member 51a and a third right through-hole member 51b are respectively arranged on the bottom surfaces of the left fixing member 1 and the right fixing member 2, the third left through-hole member 51a and the third right through-hole member 51b are symmetrical, and when the left fixing member 1 and the right fixing member 2 wrap the patient's ankle, they can be combined to form the third through-hole member 51.

[0056] Among them, the first left through hole member 31a and the first right through hole member 31b are respectively provided with through holes symmetrical to each other, so that the first through hole member 31 formed by merging has a first through hole; the second left through hole member 41a and the second right through hole member 41b are respectively provided with through holes symmetrical to each other, so that the second through hole member 41 formed by merging has a second through hole; the third left through hole member 51a and the third right through hole member 51b are respectively provided with through holes symmetrical to each other, so that the third through hole member 51 formed by merging has a third through hole, and the diameters of the first, second and third through holes are all 5mm-10mm. After the left fixing member 1 and the right fixing member 2 are aligned with each other, the first connecting member 3, the second connecting member 4 and the third connecting member 5 are respectively passed through the first, second and third through holes of the first through hole member 31, the second through hole member 41 and the third through hole member 51 to complete the assembly of the fixing members. In some embodiments, the first connecting member 3, the second connecting member 4 and the third connecting member 5 are any one of bolts, pins and rivets.

[0057] like Figure 5As shown, when the left fixing member 1 and the right fixing member 2 are designed, guide channels are also provided on the outer surfaces of the left fixing member 1 and the right fixing member 2 according to the lesion site. The guide channels extend outward from the center point of the lesion site along the inner surface of the fixing member and protrude from the outer surface of the fixing member. To ensure reliable mechanical properties and facilitate surgical operations, the guide channels need to be away from the edge of the outer surface of the fixing member. The inner diameter of the guide channel is 3mm-5mm, the outer diameter is 7mm-12mm, and the length is 35mm-65mm. The inner diameter, outer diameter and length of the guide channel can be freely adjusted according to the patient's body surface morphology and surgical needs. The number of guide channels is greater than or equal to 1, and preferably, the number is 2. As an example, in this embodiment, a guide channel 11 is provided on the outer surface of the left fixing member 1, and a guide channel 21 is provided on the outer surface of the right fixing member 2. Since the guide channel 11 and the guide channel 21 extend outward from the center point of the lesion site along the inner surfaces of the left fixing member 1 and the right fixing member 2 and protrude from the outer surfaces of the left fixing member 1 and the right fixing member 2, the lesion site can be accurately located and surgical instruments such as a guide needle 6 can be inserted along its inner diameter to perform treatments such as diseased bone removal and new bone filling in the corresponding lesion area, ultimately achieving percutaneous closure and precise repair of the talar osteochondral 7 damage, which not only avoids repeated X-ray radiation exposure but also saves operation time.

[0058] In this embodiment, the materials of the fixing parts, through-hole parts and guide channels are all photosensitive resins, which can be produced using general precision resin 3D printing equipment. The structural design process is standardized and process-based, and the requirements for equipment, materials and labor costs are relatively low.

[0059] In some embodiments, multiple guide channels can be flexibly designed to perform multi-position and multi-directional puncture and repair operations according to the patient's bones, body surface morphology and surgical needs, thereby quickly and easily achieving multi-angle repair and reconstruction of talar osteochondral injuries.

[0060] In this embodiment, the specific operations of designing and using the 3D printed surgical device include:

[0061] Before surgery, CT scan was performed to determine the location of the lesion. Figure 6As shown in a, the Mimics Medical 20.0 software was used to 3D reconstruct the structure of the patient's foot and ankle, and the Siemons UG NX 12.0 software was used to design the structure of the 3D printed surgical device based on the 3D reconstructed structure. First, an area was selected on the medial and lateral sides of a piece of photosensitive resin, and the concave and convex morphology of the surface was thickened into a plate-like structure surrounding the ankle, thereby forming a boot shape, and the boot shape was divided into two left and right pieces by the median symmetry plane to form the "structural embryo" of the left fixture 1 and the right fixture 2. Subsequently, the center point of the lesion site was taken as point A, and a point on the outer surface of the "structural embryo" was taken as point B. When selecting point B, it is necessary to stay away from the edge of the outer surface of the "structural embryo" to ensure reliable mechanical properties and facilitate surgical operations. Connect point A and point B to form a straight line AB, and construct a hollow tube along the extension line of straight line AB. Take a small section of the hollow tube protruding from the outer surface of the "structural embryo", and fuse the small section with the "structural embryo" into one. This small section is the guide channel, with an inner diameter of 3.5mm, an outer diameter of 8mm, and a length of 40mm. Because it extends outward from the center point of the lesion site along the inner surface of the fixture and protrudes from the outer surface of the fixture during structural design, when the fixture is installed and fixed to the patient's ankle, the guide channel can accurately locate the lesion site. After the design of the fixture and the guide channel is completed, the left fixture 1 and the right fixture 2 are set to be assembled with each other in the Siemons UG NX 12.0 software. Three straight lines perpendicular to the three intersection lines (front, back, and bottom) of the left fixture 1 and the right fixture 2 are drawn according to the midpoints of the three intersection lines (front, back, and bottom) where the left fixture 1 and the right fixture 2 intersect. With one of the straight lines as the central axis, two thick and thin cylinders are made. The difference between the two cylinders forms a hollow circular tube. Six hollow circular tubes are formed in this way. The six hollow circular tubes are symmetrically connected in pairs and respectively integrated into the front, back and bottom surfaces of the left fixing member 1 and the right fixing member 2, thus completing the design of the six through-hole members (the first left through-hole member 31a, the first right through-hole member 31b, the second left through-hole member 41a, the second right through-hole member 41b, the third left through-hole member 51a, and the third right through-hole member 51b). The length of the six through-hole members is 15 mm, and the diameter of the through-holes on the through-hole members is 5 mm. When the left fixing member 1 and the right fixing member 2 are aligned with each other, the six through-hole members can be combined in pairs to form three through-hole members (the first through-hole member 31, the second through-hole member 41, and the third through-hole member 51). Finally, some holes are appropriately dug out in the plate-like area to form a hollow structure for weight reduction, thereby obtaining a 3D printed surgical device.

[0062] like Figure 6As shown in b, c and d, after the left fixing member 1 and the right fixing member 2 are aligned with each other at the ankle of the patient, the bolts are respectively inserted into the through holes of the three through-hole members to complete the installation. After the guide needle 6 accurately enters the lesion site through the guide channels 11 and 21 on the outer surfaces of the left fixing member 1 and the right fixing member 2, the bolts, the left fixing member 1 and the right fixing member 2 are removed, and surgical instruments such as a hollow drill bit are inserted along the guide needle 6 to perform treatments such as removal of diseased bones and filling of new bones at the corresponding lesion site, and finally achieve percutaneous closure and precise repair of talar osteochondral injury.

[0063] In summary, the 3D printed surgical device designed by the present invention for repairing talar osteochondral damage accurately designs a fixing part according to the patient's CT three-dimensionally reconstructed skin morphology, and uses a guide channel specially designed according to the fixing part and the lesion site to guide the precise positioning of the lesion, which not only avoids repeated X-ray radiation exposure, but also saves operation time; the entire operation does not require cutting the skin to observe the bones or inserting an arthroscopy to observe the bones, which greatly simplifies the surgical process; in addition, the surgical device can flexibly design multiple guide channels according to the patient's bones, body surface morphology and surgical needs to achieve multi-angle repair and reconstruction; and the surgical device is easy to operate, low cost, and is not affected by limb movement.

[0064] Although the content of the present invention has been described in detail through the above preferred embodiments, it should be appreciated that the above description should not be considered as a limitation of the present invention. After reading the above content, it will be apparent to those skilled in the art that various modifications and substitutions of the present invention will occur. Therefore, the protection scope of the present invention should be limited by the appended claims.

Claims

1. A 3D printed surgical device for repairing talus osteochondral damage, characterized in that: It includes fixing parts, connecting parts and guide channels; The fixing member is a curved sheet structure, and the fixing member includes a symmetrical left fixing member and a right fixing member; The connecting member connects the left fixing member and the right fixing member; The guide channel extends outward from the center point of the lesion site along the inner surface of the fixing member and protrudes from the outer surface of the fixing member.

2. The 3D printing surgical device for repairing talar osteochondral damage according to claim 1, characterized in that: The number of the guide channels is greater than or equal to one.

3. The 3D printing surgical device for repairing talar osteochondral damage according to claim 1, characterized in that: The guide channel is arranged to be away from the edge position of the outer surface of the fixing member.

4. The 3D printing surgical device for repairing talar osteochondral damage according to claim 1, characterized in that: The inner diameter of the guide channel is 3mm-5mm, the outer diameter is 7mm-12mm, and the length is 35mm-65mm.

5. The 3D printing surgical device for repairing talar osteochondral damage according to claim 1, characterized in that: The guide channel is used for inserting a guide needle to treat the lesion site.

6. The 3D printing surgical device for repairing talar osteochondral damage according to claim 1, characterized in that: The outer surfaces of the left fixing member and the right fixing member are respectively provided with a plurality of left through-hole members and right through-hole members, the left through-hole members and the right through-hole members are symmetrical to each other and protrude from the outer surfaces of the left fixing member and the right fixing member, and the protruding length of the left through-hole members and the right through-hole members is 10mm-25mm; The left through-hole component and the right through-hole component are matched with each other to form a through-hole component.

7. The 3D printing surgical device for repairing talar osteochondral damage according to claim 6, characterized in that: The left through hole member and the right through hole member are respectively provided with through holes which are symmetrical to each other, and the diameter of the through holes is 5mm-10mm.

8. The 3D printing surgical device for repairing talar osteochondral damage according to claim 7, characterized in that: The connecting member passes through the through holes on the left through-hole member and the right through-hole member to connect the left fixing member and the right fixing member.

9. The 3D printing surgical device for repairing talar osteochondral damage according to claim 1, characterized in that: The connecting piece is any one of a bolt, a pin and a rivet.

10. The 3D printing surgical device for repairing talar osteochondral damage according to claim 1, characterized in that: The fixing piece is made by 3D printing.

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