Source: https://patents.google.com/patent/JP2016530021A/en
Timestamp: 2020-01-27 00:29:43
Document Index: 615931716

Matched Legal Cases: ['art 3', 'art 2', 'art 3', 'art 12', 'art 11', 'art 15', 'art 2', 'art 13', 'art 3', 'art 2', 'art 3', 'art 2', 'art 3', 'art 3', 'art 3', 'art 2', 'art 3', 'art 3', 'art 3', 'art 2', 'art 3', 'art 2', 'art 3']

JP2016530021A - Adjustable modular spacer device for knee joint - Google Patents
Adjustable modular spacer device for knee joint Download PDF
JP2016530021A
JP2016530021A JP2016539689A JP2016539689A JP2016530021A JP 2016530021 A JP2016530021 A JP 2016530021A JP 2016539689 A JP2016539689 A JP 2016539689A JP 2016539689 A JP2016539689 A JP 2016539689A JP 2016530021 A JP2016530021 A JP 2016530021A
JP2016539689A
JP6393333B2 (en
カペレティ，アヴァ
2013-09-09 Application filed by カペレティ，アヴァ filed Critical カペレティ，アヴァ
2013-09-09 Priority to PCT/IT2013/000235 priority Critical patent/WO2015033361A1/en
2016-09-29 Publication of JP2016530021A publication Critical patent/JP2016530021A/en
2018-09-19 Publication of JP6393333B2 publication Critical patent/JP6393333B2/en
The adjustable modular spacer device (1) for the knee joint is fixed to the tibia part (3) suitable for being fixedly coupled to one end of the tibia near the knee joint and to one end of the femur near the knee joint. And a femoral portion (2) adapted to contact and articulate with the tibia (3), the femoral portion comprising at least one condylar joint (7, 8) and an intercondylar central body The intercondylar central body (6) and the at least one condylar joint (7, 8) are separate parts of the femur (2).
TECHNICAL FIELD OF THE INVENTION The present invention relates to an adjustable modular spacer device for provisional replacement of an artificial knee joint.
Such artificial joints may have to be removed for various reasons such as infection.
Adjustable modular spacer device allows new artificial joints to be implanted and even walked for good movement of the joint itself and for the time required for joint treatment or the period from removal of the artificial joint to implantation of the next artificial joint The actual anatomy of the patient can be determined to maintain the joint space necessary to provide gender to the patient.
Prior Art In the field of artificial joint implantation, it is known that such devices may have to be removed for a variety of reasons, including local infection of the joint that occurs after the artificial joint is implanted.
In such a case, after removing the first artificial joint, it is necessary to treat the joint seat with an appropriate antibiotic medication before a new artificial joint can be implanted.
It is fundamental to maintain the joint space necessary for the implantation of a new prosthetic joint to prevent tissue shortening, joint atrophy, and loss of muscle tension during the treatment period.
Such a technique is known as “two-stage implantation” of an artificial joint.
Provisional joint spacers for knees, typically made of bone cement, are commercially available that can perform these functions.
Some spacers are manually shaped by the surgeon during the implantation procedure of the spacer itself, depending on the size and shape of the implantation site.
However, the disadvantages of the spacers are the difficulty for surgeons who have to have extended operative time and have sufficient dexterity and experience as the device is molded during surgery, and the risk of contamination of the device during fabrication. Will increase.
Furthermore, homemade spacers have the disadvantage that they can reduce the mobility of the joint being treated.
Furthermore, spacers for knee joints that have been molded in advance and can be immediately used for implantation are also commercially available. Such a spacer has two joint sides corresponding to both the femur and the tibia that are articulated together.
However, since the size and shape of this device are made in advance, it is necessary to replace artificial joints of various sizes and types, or if there are defects or abnormalities in the parts themselves, implant the artificial joints. It cannot be completely adapted to the site.
Therefore, this spacer cannot be closely matched to the size of the patient's knee, thus ensuring sufficient mobility of the joint and thus a good quality of life for the patient while waiting for a new prosthesis to be implanted. It is difficult. Alternatively, it may be necessary to remove more bone than strictly required.
DISCLOSURE OF THE INVENTION One object of the present invention is to improve the state of the art.
Another object of the present invention is to provide an adjustable modular spacer device for a knee joint that can be pre-shaped and simultaneously adapted to the actual condition of the knee joint to be implanted.
Another object of the present invention is the adjustability for the knee joint which can be adapted to various actual anatomical sizes of the joint, while also considering the amount of bone tissue excised after removal of the infected artificial joint. It is to provide a modular spacer device.
Another object of the present invention is to provide an adjustable modular spacer device for the knee joint that ensures high mobility and stability of the joint itself.
Yet another object of the present invention is to provide an adjustable modular spacer device for the knee joint that ensures that the patient has a good quality of life once the device is implanted.
According to one aspect of the invention, it is foreseen to be an adjustable modular spacer device for a knee joint according to the appended claim 1.
The invention further relates to a method for assembling an adjustable modular spacer device for a knee joint according to the appended claim 24.
The invention further relates to a combination of parts of an adjustable modular spacer device for a knee joint according to claim 27.
Other features and advantages of the present invention will become more apparent from the detailed description of the preferred but non-inclusive embodiment of a modular adjustable provisional spacer device for a knee joint, shown by way of non-limiting example in the following accompanying drawings. Become.
FIG. 1 is a perspective side view showing a femur of an adjustable modular spacer device according to the present invention before assembly. FIG. 2 is a front view showing the femur of the apparatus of FIG. FIG. 3 is a front view showing the femur of the apparatus of FIGS. 1 and 2 after assembly. FIG. 4 is a perspective view showing the assembled femur part of FIG. 3. FIG. 5 is a perspective side view showing another mold of the femur of the adjustable modular spacer device according to the present invention that is partially assembled. FIG. 6 is a front view of the tibial portion of an adjustable modular spacer device according to the present invention that has been assembled. FIG. 7 is a front view of the tibia portion of FIG. 6 before assembly. 8 is a perspective side view of the tibia part of FIG. 7 before assembly. FIG. 9 is a perspective side view showing the tibia part after assembly in FIG. 6. FIG. 10 is a perspective side view showing one embodiment of the femoral portion of the adjustable modular spacer device according to the present invention after assembly. FIG. 11 is a perspective side view showing another embodiment of the femur of the adjustable modular spacer device according to the present invention after assembly. FIG. 12 is a perspective side view showing one embodiment of the tibial portion of the adjustable modular spacer device according to the present invention after assembly. FIG. 13 is a perspective side view showing another embodiment of the tibial portion of the adjustable modular spacer device according to the present invention after assembly.
The human body can be divided into regions along a plane that theoretically passes through the human body according to the following terms.
The “sagittal plane” is a left-right symmetrical plane that extends from the front to the rear and divides the human body into left and right portions. The sagittal plane includes a median sagittal plane that divides the human body into two substantially symmetrical portions and a side sagittal plane that is parallel to the mid sagittal plane. Accordingly, the position or direction relative to the human body is defined as “center” or “middle” when in the mid-sagittal plane, and “side” when close to the lateral sagittal plane.
A “crown” plane is a plane extending perpendicular to the sagittal plane.
Finally, a “transverse” plane is a plane that extends perpendicular to both the sagittal and coronal planes.
Similarly, an “anatomical axis” can be defined. The main axis is the “vertical” or vertical axis that is perpendicular to the ground when the body is standing, the “horizontal” or horizontal axis that is from left to right (or vice versa) and perpendicular to the vertical axis, and the human body Including a “sagittal” or anteroposterior axis from the rear surface to the front surface (or vice versa). The last axis is perpendicular to the other two axes.
As used herein below, phrases such as “front”, “rear”, “vertical” or “horizontal”, “lower” or “upper” refer to the direction taken by the human body when standing.
The knee joint includes the bone structure of the distal epiphysis of the femur, the proximal epiphysis of the tibia, and the patella. The articular surface is represented by the femoral condyle and the tibial base. The distal epiphysis of the femur consists of two condyles, the middle and the side, which join together on the anterior side to form the diaphysis and branch laterally on the posterior side. The space created between the condyles is the intercondylar fossa. The anterior side of the distal epiphysis is a triangular area of the patella that is articulated with the patella, which is concave in the side and convex in the length.
Since the articular surface of the femur, which consists of the lower surfaces of the two condyles, is flat and “U” shaped, it is articulated with the flat area of the tibia, ie, the upper surface of the proximal end of the tibia.
Referring to the accompanying drawings, reference numeral 1 schematically represents an adjustable modular spacer device for a knee joint.
Such spacers, as described in more detail herein below, are particularly suitable for severe cases where critical surgery is required on the patient's knee joint, both semicondylar and fully condylar. Can be used to replace an infected knee prosthesis. An advantage of the adjustable modular spacer device is that the surgeon can select and assemble the device according to actual requirements after assessing the actual condition of the joint under surgery after implantation. Will be described in more detail below.
The adjustable modular spacer device 1 comprises only the femur 2 and the tibia 3. The femur 2 is suitable for being fixed to the end of the femur close to the knee joint. The tibia part 3 is suitable for fixing to the end part of the tibia with a knee joint.
The adjustable modular spacer device 1 according to the present invention is actually a provisional device and is not provided with a patella portion for the purpose of reducing the complexity of implantation. In order to perform a therapeutic function, it is not necessary to provide a portion that replaces the patella like a permanent prosthesis because it is placed in the human body for a short period of time. The femoral part 2 and the tibia part 3 are suitable for moving the patient's knee joint to regenerate the patient's knee joint.
The femur 2 and tibia 3 each comprise at least two separate parts that are assembled together to fit the size of the connecting epiphysis and are described in more detail herein below. In practice, due to the above features, the adjustable modular spacer device 1 is used as a semicondylar spacer, i.e. having either a central articular surface or a lateral articular surface, or used as a full spacer. That is, it has both a central articular surface and a lateral articular surface. In practice, at the time of implantation, the surgeon assembles the various parts constituting the femur 2 and / or tibia 3 based on actual surgical and anatomical requirements.
As shown in FIGS. 3 and 4, the femur 2 is substantially “U” -shaped in its assembled state, and is suitable for contacting the concave inner surface 4 contacting the bone seat and the tibia 3. And a convex outer surface 5.
The inner surface 4 is secured to the end of the femur that is contacted via bone cement.
1 and 2 show the femur 2 before assembly. The femur 2 includes an intercondylar central body 6 and at least one condylar joints 7 and 8. According to one aspect of the invention, the femur 2 comprises two condylar joints 7 and 8, one central to the intercondylar central body 6 and the other lateral to the intercondylar central body 6. Placed in.
The inner surface 4 of the femur 2 is formed by an intercondylar central body 6 and at least one condylar joints 7 and 8.
The outer surface 5 of the femur 2 is formed by at least one condylar joint 7, 8.
The intercondylar central body 6 has a substantially “L” shape and includes a first vertical arm 9 and a second horizontal arm 10 that are substantially perpendicular to each other.
The first vertical arm 9 substantially corresponds to the anterior space between the femoral condyles.
The second horizontal arm 10 corresponds to the space between the femoral condyles relative to the intercondylar fossa.
Accordingly, the first arm 9 extends along the longitudinal axis or the vertical axis of the human body.
The second arm 10 extends along the sagittal axis of the human body and is disposed along the cross section of the human body.
At least one extension 11 extends outwardly from the second horizontal arm 10 laterally and / or centrally along the transverse axis of the human body, the extension 11 being connected to the arm 10 from which the extension branches. On substantially the same cross section. According to one aspect of the present invention, two extensions 11 are provided, one disposed laterally with respect to the central body 6 or the second horizontal arm 10 and the other disposed centrally.
The intercondylar central body 6 and the condylar joints 7 and 8 are separate parts of the femur 2 but can be associated with each other to form a single body and are described in more detail herein below. .
At least one condylar joint 7, 8 is disposed laterally and / or centrally of the central body 6 and substantially corresponds to the femoral condyle and the articular surface formed by them.
At least one condylar joint 7, 8 is substantially “U” shaped and has an anterior portion 12, a central portion 13, and a posterior portion 14.
The anterior portion 12 of the at least one condylar joint 7, 8 has a vertical extension substantially corresponding to the surface of the first vertical arm 9 of the central body 6, ie along the sagittal plane of the human body. The front part 12 is located in front of the human body.
The central portion 13 is substantially located on the same surface as the second horizontal arm 10 of the central main body 6, that is, on the cross section of the human body.
The anterior portion 14 substantially corresponds to the posterior surface of the femoral condyle.
A part of the intercondylar central body 6 and a part of the at least one condylar joint 7, 8 constitute the front face 30 of the device which substantially corresponds to the front face of the femoral end. Specifically, the front surface 30 is composed of at least one anterior portion 12 of the condylar joint portions 7, 8 and the first vertical arm 9 of the intercondylar central body 6.
At least one seat 15 is provided in the central portion 13 of the at least one condylar joint 7, 8. The seat portion 15 corresponds to the extended portion 11 of the central body 6 and constitutes one housing. Thus, the expansion part 11 is accommodated in the seat part 15, and the assembly of the femoral part 2 of the adjustable modular spacer device 1 according to the present invention is determined. At least one seat 15 is arranged in the central part 13 on the inner surface 4 of the femur 2. Thus, the inner surface 4 comprises an intercondylar central body 6 and an anterior portion 12 and a posterior portion 14 of at least one condylar joint 7, 8. The seat 15 is positioned on the inner surface 4 of the femur 2 and the extension 11 is accommodated therein, so that the femoral portion 2 is moved between the intercondylar central body 6 and the at least one condylar joints 7 and 8. The bone cement used to fix to the corresponding bone part can be optimally bonded. Furthermore, the tibial portion 3 and the outer surface 5 of the joint are smooth without any irregularities, and are continuous without interruption, thus promoting an appropriate knee joint.
Between the seat portion 15 and the expansion portion 11, there are provided some fitting and fixing means 16 that can join the condylar joint portions 7 and 8 to the intercondylar central body 6.
In practice, as described above, the surgeon selects various portions of the femur 2 to best fit the adjustable modular spacer device 1 to the size of the joint to be treated and the specific surgical requirements of the patient, Assemble them.
According to one aspect of the present invention, the fitting and fixing means is detachable.
According to one aspect of the present invention, the fitting and fixing means 16 has a shape of a protrusion 16 ′ that can be inserted into the corresponding hole 16 ″.
Alternatively, the fitting and fixing means 16 may be any known combination suitable for two-part coupling, i.e., fixation to a corresponding other means, such as a cap-type coupling means, a mechanical fastening means, a detachable mechanical fastening means, etc. It can be a means.
According to one aspect of the present invention, the lateral fitting and fixing means 16 in the condylar joint portion 7, for example, the corresponding expansion portion 11, is a central fitting and fixing means in the condylar joint portion 8, for example, the corresponding expansion portion 11. 16 is different. In this way, during implantation, the condylar joint at the lateral position can be reliably coupled to the corresponding extension, avoiding the possibility of errors during the assembly of the femur 2.
Once assembled, the peripheral surface of the central body 6 and the peripheral surfaces of the joints 7, 8 are flat so that a femur similar to a pre-formed femur as a single piece known in the market can be obtained. It matches.
As will be described herein below, the size of the femur 2 can be selected to suit the surgeon's needs and the structure of the implant location, but to enhance the modularity of the adjustable modular spacer device 1, At least one extension 11 and at least one seat 15 have the same size and coupling mode.
At least one of the condylar joints 7, 8 has a size D1, D2, or D3. Specifically, the size D1 is smaller than D2 and further smaller than D3. During implantation, the surgeon can select the size D1, D2, or D3 depending on the patient's actual needs. Accordingly, the at least one condylar joint portion 7, 8 has a different size so that it can be selected according to the size and shape of the knee joint.
All sized joints 7, 8 are associated with the central body 6 by means of fitting and fixing means 16 so as to achieve a complete connection and assembly of the femur 2.
Thus, the femur 2 is composed of many parts and is modular because it is adjustable, and by replacing the part and selecting a more appropriately sized part, the anatomical requirements of the patient Can be adapted as much as possible.
Furthermore, as illustrated in FIG. 5, a joint portion 7 having a size different from that of the joint portion 8 can be selected according to specific requirements.
According to one aspect of the invention, the central body 6 also has a size d1, d2, or d3, where d1 is smaller than d2 and even smaller than d3.
Assuming that the fitting and fixing means 16 have the same size and the same structure, the intercondylar central body 6 of any size can be assembled to the at least one condylar joint 7 or 8 of any size. Accordingly, the intercondylar body 6 has different sizes so that it can be selected according to the size and shape of the knee joint.
Therefore, the surgeon selects the part of the femur 2 necessary for implantation and then selects the optimum size and assembles the whole to obtain the assembled femur 2 that best meets the specific requirements. Can do.
The tibial part 3 of the adjustable modular spacer device 1 corresponds to the tibial flat part where the femur part 2 is connected by a joint.
The tibia 3 includes an intercondylar central element 17 and at least one condylar joint base 18, 19. According to one aspect of the invention, two condylar joint bases 18, 19 are provided.
As shown in FIGS. 6 and 9, the tibia 3 is jointed with the outer surface 5 of the femur 2 as a whole in the assembled state, and comes into contact with the bone seat portion and the upper surface 21 that is slightly concave. And a lower surface 22.
The lower surface 22 is fixedly coupled directly and through the additional tibia (not shown) to the end of the tibia that contacts via bone cement.
7 and 8 show the tibia 3 before assembly.
The intercondylar central element 17 corresponds to the second horizontal arm 10 of the intercondylar space or the intercondylar central body 6 of the femur 2. The intercondylar central element 17 is located substantially in the cross section of the human body and extends parallel to the sagittal axis of the human body.
The intercondylar central element 17 can be provided with a projection 23 at the front which is suitable for improving the connection with the femur 2 and limiting the possibility of rotation between them.
The pin 24 projects from the intercondylar central element 17, in particular from the lower surface 22. The pin 24 extends substantially vertically, that is, parallel to the longitudinal axis of the human body. The pin 24 is implanted in the tibia so as to stabilize the implantation of the tibia part 3 of the adjustable modular spacer device 1 according to the invention. The intercondylar central element 17 and the at least one condylar joint base 18, 19 are separate parts of the tibia 3, but are combined and associated to form a single body, as will be described in more detail herein below. Can do.
The at least one condylar joint base 18, 19 is arranged laterally and / or centrally with respect to the intercondylar central element 17, and at least one condylar joint part of the tibial flat part, the femoral condyle or the femoral part 2. 7 and 8 substantially correspond to the ground and the rotation base.
The surfaces of the joint bases 18 and 19 corresponding to the upper surface 21 are slightly recessed so as to correspond to the convex surfaces of the joint portions 7 and 8 of the femur.
The upper surface 21 is formed by at least one condylar joint base 18, 19 and an intercondylar central element 17.
The lower surface 22 is formed by the intercondylar central element 17.
The at least one second extension 25 is located approximately in the transverse plane of the human body and projects outwardly from the intercondylar central element 17 laterally and / or centrally along the transverse axis of the human body.
Each of the condylar joint bases 18, 19 has at least one seat 26 suitable to receive at least one second extension 25.
Specifically, the at least one seat 26 is on at least one second extension 25 of the central element 17 of the tibia 3 and below the condylar joint bases 18, 19 on the rest surface of the base itself. Be placed. By accommodating at least one second extension 25 and at least one seat 26, the tibial part 3 of the adjustable modular spacer device 1 according to the invention is assembled.
Between the seat portion 26 and the second extension portion 25, a fitting fixing means 16 capable of fixing the condylar joint bases 18 and 19 to the central element 17 is provided.
In practice, as described above, the surgeon selects various parts of the tibia 3 to best adapt the adjustable modular spacer device 1 to the size of the joint to be treated and the specific surgical requirements of the patient. Assemble. According to one aspect of the present invention, the fitting and fixing means is detachable.
Alternatively, the fitting and fixing means 16 may be any known means suitable for fixing the corresponding other means so as to form a bond between the two parts, such as a plug-in coupling means, a mechanical hooking means. It can be a detachable mechanical hooking means.
According to one aspect of the present invention, the lateral fitting and fixing means 16 on the condylar joint base 18, eg, the second extension 25, is connected to the center of the condylar joint base 19, eg, the second extension 25. Different from the fitting and fixing means 16.
In this way, during implantation, for example, the lateral joint base can be securely coupled to the corresponding second extension so as to avoid possible errors during the assembly of the tibia part 3.
Once assembled, the peripheral surface of the intercondylar central element 17 and the peripheral surfaces of the condylar joint bases 18, 19 are matched to achieve a tibia similar to that pre-formed as a single piece known in the market. . As described above, the size of the tibia 3 can be selected to suit the surgeon's needs and the structure of the implant location, as will be described herein below, but the modularity of the adjustable modular spacer device 1 To enhance, the second extension 25 and the seat 26 have the same size and coupling mode. Therefore, the surgeon can select the portion of the femur 2 necessary for implantation, determine the optimum size, assemble the whole, and obtain the assembled femur 2 that best meets the specific requirements.
The condylar joint bases 18, 19 have shoulders 27 at the lateral or central ends. The shoulder 27 protrudes from the cross section of the joint base 18, 19 toward the tibia part and covers at least one second extension 25. The shoulder 27 provides a second extension 15 with any size or size of the condylar joint bases 18, 19 in the intercondylar central element 17 of any size, as will be described in more detail herein below. Can be accommodated. In practice, in addition to the size of the fitting and fixing means 16, the size of the extension 11, or the second extension 25, the seat 15, or the second seat 26 is determined based on the actual needs of the patient. The intercondylar central body 6, so that they can be connected to various parts of any size of the adjustable modular spacer device 1 according to the invention, in particular It is identical to any size of the condylar joints 7, 8 or central condylar element 17 and condylar joint bases 18, 19.
In practice, the condylar joint base 18, 19 has a size T1, T2, or T3. Specifically, the size T1 is smaller than T2 and smaller than T3. At the time of implantation, the surgeon can select a size T1, T2, or T3 depending on the patient's actual needs. All sizes of the condylar joint bases 18, 19 can be associated with the intercondylar central element 17 using the fitting and fixing means 16 so as to achieve the connection and assembly of the tibia 3. Accordingly, the intercondylar central element 17 has a different size so that it can be selected according to the size and shape of the knee joint.
Thus, the tibia part 3 is composed of many parts and is modular because it is adjustable, and by replacing the part and selecting a more appropriately sized part, the patient's anatomical requirements can be met. It can be adapted as much as possible.
Furthermore, the condylar joint base 18 having a different size from the condylar joint base 19 can be selected according to specific requirements.
According to one aspect of the invention, the intercondylar central element 17 can also have a size t1, t2, or t3, where t1 is smaller than t2, or even t3.
Assuming that the fitting and fixing means 16 have the same size and the same structure, the intercondylar central element 17 of any size can be assembled to the condylar joint bases 18 and 19 of any size. Thus, the at least one condylar joint base 18, 18 has a different size so that it can be selected depending on the size and shape of the knee joint.
Once the correct size and shape of the adjustable modular spacer device 1 is established, the mating and securing means 16 is secured using bone cement or other material suitable for the purpose.
The femur 2 and tibia 3 are pre-formed only with biocompatible materials.
The biocompatible material is porous.
The biocompatible material can be selected from metals, alloys, organometallic compounds, ceramics, porous resins, plastic materials, and / or combinations thereof.
Specifically, the plastic material described above can be selected from thermoplastic polymers such as acrylic resins, polyethylene, polypropylene, polyester, thermoformable polymers, and other similar materials.
According to one aspect of the present invention, the biocompatible material is a bone cement such as polymethyl methacrylate (PMMA).
The biocompatible material described above can be loaded with drugs and / or therapeutic products due to its porosity.
Filling the biocompatible material with drug and / or therapeutic product can be performed directly by the manufacturer or surgeon prior to implantation. Furthermore, depending on the specific requirements of the patient, the surgeon fills the adjustable modular spacer device 1 already filled with the first drug and / or treatment product by the manufacturer with the second drug and / or treatment product. The first drug and / or therapeutic product can be different from the second drug and / or therapeutic product.
In another embodiment, at least one drug and / or therapeutic product can be added to the biocompatible material during manufacture of the adjustable modular spacer device 1.
The porosity of the material from which the adjustable modular spacer device 1 is manufactured can be selected to release the drug and / or therapeutic substance at a low concentration for a long period of time or at a high concentration for a short period of time. In this way, the patient's specific requirements can be satisfied.
Of course, each part of the adjustable modular spacer device 1 can carry specific drugs and / or therapeutic products depending on the requirements, or at the same time can exclude the substances.
Furthermore, if only a small part of the knee joint is damaged or a local infection has occurred, the surgeon may choose to use only the femoral part 2 or tibia part 3 of the adjustable modular spacer device 1. You can choose.
In addition, if the knee joint damage is hemi-condylar, or if the hemi-condylar prosthesis is replaced, i.e. only involving either the lateral or central area, or there is a local infection In this case, as shown in FIGS. 10 to 13, only a necessary portion, that is, only one of the condylar joint portions 7 and 8 or only one of the condylar joint bases 18 and 19 can be selected. Thus, the surgeon selects the parts and size of the various parts of the adjustable modular spacer device 1 by performing a specific evaluation prior to implantation of the device itself.
Even in such a case, the whole can be assembled using the above-mentioned portion having a desired size. The extension 11 or the second extension 25 that is not used because the corresponding portion of the knee joint is not included in the implant can be excised and removed by the surgeon using common surgical instruments. Alternatively, the intercondylar central body 6 and / or the intercondylar central element 17 can only foresee the extension 11 and / or the second extension 25 according to requirements. An example of the above embodiment is shown in FIGS.
Finally, between the extension 11 and the intercondylar central body 6 and / or between the second extension 25 and the intercondylar central element 17 so as to simplify the separation of parts not used and unnecessary for the surgeon. Separation means or cuts can be provided in the joint seam between.
The femur 2 and tibia 3 that contact the corresponding bone tissue at face 4 and face 22 comprise at least one groove 20 that can promote bone cement adhesion.
The at least one groove 20 can contain and hold bone cement to prevent the bone cement from diffusing or flowing out during the bonding step between the femur 2 or tibia 3 and the bone tissue.
The present invention further comprises a method for assembling an adjustable modular spacer device 1 for a knee joint comprising only the femur 2 and the tibia 3 wherein the femur 2 is fixedly attached to one end of the femur close to the knee joint. Suitable for joining, the tibia 3 is suitable for being fixedly joined to one end of the tibia near the knee joint, and the femur 2 is suitable for contacting and articulating with the tibia 3. The method comprises the step of providing a femur 2 comprising an intercondylar central body 6 and at least one condylar joint 7, 8, wherein the at least one condylar joint 7, 8 is of size D 1, D 2, or D3, size D1 is smaller than D2, size D2 is smaller than D3, and / or intercondylar central body 6 has size d1, d2, or d3, d1 is smaller than d2, and d2 is smaller than d3.
The method according to the invention comprises the step of selecting a size D1, D2 or D3 of at least one condylar joint 7, 8 and a size d1, d2 or d3 of the intercondylar central body 6.
Next, a step is provided for associating the selected size of the at least one condylar joint 7, 8 with the selected size of the intercondylar central body 6. A step of assembling the femur 2 is also provided.
Instead of the above steps or in combination with the above steps, the method according to the invention comprises the step of arranging a tibial part 3 comprising at least one condylar joint base 18, 19 and an intercondylar central element 17, comprising at least One condylar joint base 18, 19 has a size T1, T2, or T3, size T1 is smaller than T2, size T2 is smaller than T3, and the intercondylar central element 17 has a size t1, t2, or t3. T1 is smaller than t2, and t2 is smaller than t3.
The method according to the invention comprises the step of selecting the size T1, T2 or T3 of at least one condylar joint base 18, 19 and the size t1, t2 or t3 of the intercondylar central element (17). The method further comprises associating at least one condylar joint base 18, 19 of a selected size with the selected size of the intercondylar central element 17 and assembling the tibia part (3).
The method according to the invention comprises the steps of placing an intercondylar central body 6 with at least one extension 11 and placing at least one condylar joint 7, 8 with at least one seat 15. Inserting at least one extension portion 11 into at least one seat portion 15, coupling at least one extension portion 11 and at least one seat portion 15 by fitting and fixing means 16, and And assembling the femur 2.
The method according to the invention comprises the step of positioning an intercondylar central element 17 with at least one second extension 25 and at least one condylar joint base 18 with at least one second seat 26. , 19, inserting at least one second extension 25 into at least one second seat 26, at least one second extension 25 and at least one second seat The step of connecting the portion 26 with the fitting fixing means 16 and the step of assembling the tibia portion 3 in this way are further provided.
In order to give the surgeon maximum freedom of choice, the intercondylar central body 6, the intercondylar central element 17, and the condylar joint bases 18, 19 of the condylar joints 7, 8 of the femur 2 are specified in separate packages. Can be summarized in size. In practice, elements of each size in the femur can be combined with other elements of any size in the femur, and can be articulated with any size tibia and vice versa. It is.
In addition, the shape of the adjustable modular spacer device 1 described above provides high mobility of the knee joint and movement similar to a natural joint, despite different anatomical requirements between the various joints of the patient. Can be earned.
The ability to add drugs and / or treatment products to the adjustable modular spacer device 1 in advance or later allows treatment of various local infections of the joint seat and achieves an optimal state for the implantation of new prosthetic joints can do.
The present invention relates to a combination of parts of an adjustable modular spacer device 1 for a knee joint having only a femur 2 and a tibia 3, wherein the femur 2 is fixedly coupled to one end of the femur close to the knee joint. The tibial part 3 is suitable for being fixedly coupled to one end of the tibia near the knee joint, the femoral part 2 is suitable for contacting and articulating with the tibia part 3, and the femoral part 2 comprises at least one condylar joint 7, 8 and an intercondylar central body 6 and / or the tibial part 3 comprises an intercondylar central element 17 and at least one condylar joint base 18, 19; One condylar joint 7, 8 has size D1, D2, or D3, size D1 is smaller than D2, size D2 is smaller than D3, and / or intercondylar central body 6 is of size d1, d2. Or d3, d1 is more than d2 Small, d2 is smaller than d3, and / or at least one condylar joint base 18, 19 has size T1, T2, or T3, size T1 is smaller than T2, and size T2 is smaller than T3, And / or the central element 17 has a size t1, t2, or t3, where t1 is smaller than t2 and t2 is smaller than t3.
The present invention thus contemplated can be modified or modified in various ways under the same inventive concept.
Moreover, all details can be replaced with other technically equivalent elements. Thus, in practice, the materials used and the uncertain shapes and sizes can meet the requirements without departing from the scope of protection of the following claims.
U.S. Patent Publication No. 2006/01900086 A1 discloses a modular prosthetic device for permanent knee replacement comprising a plurality of components. Such an artificial joint device is very complicated to assemble as the number of parts increases. The prosthetic device according to US 2006/01900086 A1 does not offer the possibility of assembling a central femur with two sized femurs of different sizes based on the human anatomy .
An adjustable modular spacer device (1) for a knee joint comprising only a femur (2) and a tibia (3), the femur (2) being fixed to one end of the femur close to the knee joint The tibial portion (3) is suitable for being fixedly connected to one end of the tibia near the knee joint, and the femoral portion (2) is in contact with the tibial portion (3) The femoral part (2) is suitable for being ligated by a joint, and the femoral part (2) is in contact with the concave inner surface (4, 6, 7, 8) in contact with the end part of the femur and the tibial part (3) in contact with the condylar joint. The tibial portion (3) is in contact with the femoral portion (2) to form a condylar joint (21, 17, 18, 19) and a lower surface (22, 17) in contact with the end of the tibia, the femur (2) having at least one condylar joint (7, 8). And / or the intercondylar central body (6) and / or the tibia (3) comprises an intercondylar central element (17) and at least one condylar joint base (18, 19), the intercondylar central body ( 6) and the at least one condylar joint (7, 8) and / or the intercondylar central element (17) and the at least one condylar joint base (18, 19) Or an adjustable modular spacer device (1), characterized in that it is a separate part of the tibia (3).
The intercondylar central body (6) of the femur (2) and the at least one condylar joint (7, 8) and / or the intercondylar central element (17) of the tibia (3); Adjustable modular spacer device (1) according to claim 1, characterized in that the at least one condylar joint base (18, 19) has a different size so that it can be selected depending on the size and shape of the knee joint. 1).
Adjustable modular spacer device (1) according to claim 1 or 2, characterized in that the intercondylar central body (6) can be associated with the at least one condylar joint (7, 8).
The at least one condylar joint (7, 8) is disposed centrally or laterally with respect to the intercondylar central body (6), or two condylar joints (7, 8) are disposed between the condyles. 4. Adjustable modular spacer device (1) according to any one of claims 1 to 3, characterized in that it is arranged centrally or laterally with respect to the central body (6).
Adjustable modular spacer device (1) according to claim 1, characterized in that the femur has a cross-section parallel to the sagittal plane of the human body which is substantially "U" shaped.
A part of said intercondylar central body (6) and a part of said at least one condylar joint (7, 8) constitute a front surface (30), according to any one of claims 1 to 5 Adjustable modular spacer device (1).
The intercondylar central body (6) is "L" shaped and has a first vertical arm (9) and a second horizontal arm (10). Adjustable modular spacer device (1).
The at least one condylar joint (7, 8) is substantially "U" shaped and has an anterior portion (12), a central portion (13) and a posterior portion (14). Adjustable modular spacer device (1) according to any of 1 to 7.
The front part (12) of the at least one condylar joint part (7, 8) and the first vertical arm (9) of the intercondylar central body (6) constitute a front face (30). Adjustable modular spacer device (1) according to any of the preceding claims.
10. Adjustment according to any one of the preceding claims, characterized in that the central body (6) comprises at least one extension (11) extending along the transverse axis of the human body and located in the cross section of the human body. Modular spacer device (1).
The at least one joint (7, 8) comprises at least one seat (15) that can be associated with at least one extension (11) of the central body (6). Adjustable modular spacer device (1) according to any of 1 to 10.
Modular modularity according to any of the preceding claims, characterized in that the seat (15) is arranged in the central part (13) of the inner surface (4) of at least one joint (7, 8). Spacer device (1).
The concave inner surface (4) of the femur (2) includes the intercondylar central body (6), the at least one extension (11), and the at least one condylar joint (7, 8). Adjustable modular spacer device (1) according to any of the preceding claims, characterized in that it consists of the front part (12) and the rear part (14).
The intercondylar central element (17) of the tibial part (3) is located in a transverse section of the human body and / or the intercondylar central element (17) comprises a pin (24) projecting longitudinally. Adjustable modular spacer device (1) according to any of the preceding claims.
The intercondylar central element (17) comprises at least one second extension (25) extending laterally and / or centrally along the transverse axis of the human body and located in the transverse plane of the human body. 15. Adjustable modular spacer device (1) according to any one of the preceding claims.
The at least one condylar joint base (18, 19) is suitable for accommodating the at least one second extension (25) and can be associated with the at least one second extension (25). 16. Adjustable modular spacer device (1) according to any of the preceding claims, characterized in that it forms at least one second seat (26) that can be formed.
The at least one condylar joint base (18, 19) is configured to cover the central end or the side to cover one central end or one lateral end and the at least one second extension (25). 17. Adjustable modular spacer device (1) according to any of the preceding claims, characterized in that it forms at least one shoulder (27) arranged at the end and projecting towards the tibia.
The femur (2) and / or the tibia (3) between the intercondylar central body (6) and the at least one condylar joint (7, 8) and / or between the condyles A projection (16 ′), a base coupling means, a detachable mechanical fixation, arranged between the central element (17) and the at least one condylar joint base (18, 19), corresponding to the hole (16 ″) 18. Adjustable modular spacer device (1) according to any of claims 1 to 17, characterized in that it comprises fitting and fixing means (16) such as means, mechanical fixing means.
The fitting and fixing means (16) is provided between the at least one seat (15) and the at least one extension (11) of the femur (2) and / or the tibia (3). 19. Modular modularity according to any one of claims 1 to 18, characterized in that it is located between the at least one second seat (26) and the at least one second extension (25). Spacer device (1).
20. Adjustable modular spacer device (1) according to any of the preceding claims, characterized in that the fitting and fixing means (16) are detachable.
The femur (2) and the tibia (3) are metal, alloy, organometallic compound, ceramic, porous resin, plastic material, thermoplastic polymer, acrylic resin, polyethylene, polypropylene, polyester, thermoformable polymer, Preformed and made from a biocompatible and porous material selected from at least one of bone cement, polymethyl methacrylate (PMMA), combinations thereof,
21. According to any of the preceding claims, characterized in that the biocompatible material is filled or can be filled or at least one drug and / or therapeutic product can be added or added. Modular spacer device (1).
22. The femur (2) and / or the tibia (3) comprises at least one groove 20 that contacts the end of the femur and / or tibia. Modular spacer device (1).
The at least one condylar joint (7, 8) has a size D1, D2, or D3, the size D1 is smaller than the size D2, the size D2 is smaller than D3, and / or the intercondylar central body (6) has a size d1, d2, or d3, d1 is smaller than d2, d2 is smaller than d3, and / or said at least one condylar joint base (18, 19) is of size T1, T2. Or T3, size T1 is smaller than T2, and size T2 is smaller than T3, and / or said central element (17) has size t1, t2, or t3, and t1 is smaller than t2. Modular spacer device (1) according to any of the preceding claims, characterized in that it is small and t2 is smaller than t3.
A method of assembling an adjustable modular spacer device (1) for a knee joint, comprising only a femur (2) and a tibia (3), wherein the femur (2) is close to the knee joint Suitable for being fixedly coupled to one end of the tibia, wherein the tibia (3) is suitable for being fixedly coupled to one end of the tibia close to the knee joint, and the femur (2) is adapted to the tibia ( 3) Suitable for contacting and articulating, the method comprising:
Providing a femur (2) comprising an intercondylar central body (6) and at least one condylar joint (7, 8), wherein the at least one condylar joint (7, 8) Having size D1, D2, or D3, size D1 being smaller than D2, size D2 being smaller than D3, and / or said intercondylar central body (6) having size d1, d2, or d3; a step in which d1 is smaller than d2 and d2 is smaller than d3;
Selecting a size D1, D2, or D3 of the at least one condylar joint (7, 8) and a size d1, d2, or d3 of the intercondylar central body (6);
Associating the at least one condylar joint (7, 8) of a selected size with the intercondylar central body (6) of a selected size;
Assembling the femur (2) and / or placing a tibia (3) comprising at least one condylar joint base (18, 19) and an intercondylar central element (17), said at least one One condylar joint base (18, 19) has a size T1, T2, or T3, the size T1 is smaller than T2, the size T2 is smaller than T3, and the intercondylar central element (17) has a size t1, a step having t2 or t3, where t1 is smaller than t2 and t2 is smaller than t3;
Selecting a size T1, T2 or T3 of the at least one condylar joint base (18, 19) and a size t1, t2 or t3 of the intercondylar central element (17);
Associating at least one condylar joint base (18, 19) of the selected size with the intercondylar central element (17) of the selected size;
Assembling the tibia (3);
Positioning the intercondylar central body (6) with at least one extension (11);
Positioning said at least one condylar joint (7, 8) with at least one seat (15);
Inserting the at least one extension (11) into the at least one seat (15);
Joining the at least one extension (11) and the at least one seat (15) to assemble the femur (2) using fitting and fixing means (16);
Method for assembling an adjustable modular spacer device (1) according to claim 24.
Positioning said intercondylar central element (17) with at least one second extension (25);
Positioning said at least one condylar joint base (18, 19) with at least one second seat (26);
Inserting said at least one second extension (25) into said at least one second seat (26);
The at least one second extension part (25) and the at least one second seat part (26) are coupled to each other so as to assemble the tibial part (3) using fitting and fixing means (16). Steps,
Method for assembling an adjustable modular spacer device (1) according to claim 24 or 25.
A component group of an adjustable modular spacer device (1) for a knee joint having only a femur (2) and a tibia (3), wherein the femur (2) Suitable for being fixedly coupled to one end, suitable for the tibial portion (3) being fixedly coupled to one end of the tibia close to the knee joint, and wherein the femoral portion (2) is adapted to the tibial portion (3 The femur (2) comprises at least one condylar joint (7, 8) and an intercondylar central body (6) and / or the tibia (3) comprises an intercondylar central element (17) and at least one condylar joint base (18, 19), said at least one condylar joint (7, 8) being of size D1, D2, or D3 And size D1 is smaller than D2, size D2 is smaller than D3, and / or The intercondylar central body (6) has a size d1, d2, or d3, d1 is smaller than d2, d2 is smaller than d3, and / or the at least one condylar joint base (18, 19) Has a size T1, T2, or T3, size T1 is smaller than T2, size T2 is smaller than T3, and / or said central element (17) has size t1, t2, or t3, t1 Is a component group in which t2 is smaller than t2 and t2 is smaller than t3.
18. A group of parts according to claim 17, wherein one or more of the parts or one or more of the size of the parts are individually packaged.
JP2016539689A 2013-09-09 2013-09-09 Adjustable modular spacer device for knee joint Active JP6393333B2 (en)
PCT/IT2013/000235 WO2015033361A1 (en) 2013-09-09 2013-09-09 Adjustable modular spacer device for the articulation of the knee
JP2016530021A true JP2016530021A (en) 2016-09-29
JP6393333B2 JP6393333B2 (en) 2018-09-19
ID=49880900
JP2016539689A Active JP6393333B2 (en) 2013-09-09 2013-09-09 Adjustable modular spacer device for knee joint
US (1) US10265179B2 (en)
EP (1) EP3043751B1 (en)
JP (1) JP6393333B2 (en)
KR (1) KR20160058819A (en)
CN (1) CN105636553B (en)
AR (1) AR097583A1 (en)
AU (1) AU2013399815B2 (en)
CA (1) CA2923358A1 (en)
ES (1) ES2708553T3 (en)
WO (1) WO2015033361A1 (en)
JP2008541785A (en) * 2005-02-22 2008-11-27 マコ サージカル コーポレーション Knee implant
JP2009082713A (en) * 2007-09-28 2009-04-23 Depuy Products Inc Fixed-bearing knee prosthesis having interchangeable component
WO2013041905A1 (en) * 2011-09-19 2013-03-28 Tecres S.P.A. Temporary modular spacer device for joints of the human body
2013-09-09 WO PCT/IT2013/000235 patent/WO2015033361A1/en active Application Filing
2013-09-09 US US14/917,146 patent/US10265179B2/en active Active
2013-09-09 CA CA2923358A patent/CA2923358A1/en active Pending
2013-09-09 CN CN201380079752.5A patent/CN105636553B/en active IP Right Grant
2013-09-09 AU AU2013399815A patent/AU2013399815B2/en active Active
2013-09-09 JP JP2016539689A patent/JP6393333B2/en active Active
2013-09-09 KR KR1020167008460A patent/KR20160058819A/en active Search and Examination
2013-09-09 EP EP13812181.9A patent/EP3043751B1/en active Active
2013-09-09 ES ES13812181T patent/ES2708553T3/en active Active
2014-09-08 AR ARP140103344A patent/AR097583A1/en unknown
CN105636553A (en) 2016-06-01
CN105636553B (en) 2018-03-20
EP3043751B1 (en) 2018-10-31
EP3043751A1 (en) 2016-07-20
ES2708553T3 (en) 2019-04-10
WO2015033361A1 (en) 2015-03-12
JP6393333B2 (en) 2018-09-19
AU2013399815B2 (en) 2018-12-06
CA2923358A1 (en) 2015-03-12
US20160206434A1 (en) 2016-07-21
AR097583A1 (en) 2016-03-23
AU2013399815A1 (en) 2016-04-21
US10265179B2 (en) 2019-04-23
KR20160058819A (en) 2016-05-25
CN102058448B (en) 2016-04-27 There is the fixed-bearing knee prosthesis of interchangeable components
2017-11-08 A601 Written request for extension of time
Ref document number: 6393333