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WO2019145965A1 - Prothèse totale du genou pour fémur distal à rotation tibiale-fémorale à petit angle auto-limitante - Google Patents

Prothèse totale du genou pour fémur distal à rotation tibiale-fémorale à petit angle auto-limitante Download PDF

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Publication number
WO2019145965A1
WO2019145965A1 PCT/IN2018/050244 IN2018050244W WO2019145965A1 WO 2019145965 A1 WO2019145965 A1 WO 2019145965A1 IN 2018050244 W IN2018050244 W IN 2018050244W WO 2019145965 A1 WO2019145965 A1 WO 2019145965A1
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WO
WIPO (PCT)
Prior art keywords
tibial
femoral
knee prosthesis
total knee
distal femur
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IN2018/050244
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English (en)
Inventor
Manish Agarwal
Nirmal PANDA
Nitin KANOONGO
Balasubramanian KRISHNAMURTY
Ravi Bhallamudi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
NONFERROUS MATERIALS TECHNOLOGY DEVELOPMENT CENTRE
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NONFERROUS MATERIALS TECHNOLOGY DEVELOPMENT CENTRE
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Publication of WO2019145965A1 publication Critical patent/WO2019145965A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/3836—Special connection between upper and lower leg, e.g. constrained
    • A61F2/384—Special connection between upper and lower leg, e.g. constrained hinged, i.e. with transverse axle restricting the movement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/3836—Special connection between upper and lower leg, e.g. constrained
    • A61F2/384—Special connection between upper and lower leg, e.g. constrained hinged, i.e. with transverse axle restricting the movement
    • A61F2/385—Special connection between upper and lower leg, e.g. constrained hinged, i.e. with transverse axle restricting the movement also provided with condylar bearing surfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/38—Joints for elbows or knees
    • A61F2/3836—Special connection between upper and lower leg, e.g. constrained
    • A61F2/3854—Special connection between upper and lower leg, e.g. constrained with ball and socket joint

Definitions

  • the present invention relates to a Distal Femur Total Knee Prosthesis With Self Limiting Small Angle Tibial-Femoral Rotation, which is an orthopedic implant with 0°-150° flexion and tibial-femoral rotation of upto ⁇ 5° and has application in the field of medical surgery, specifically, in the area of mega bone replacement involving articulating knee joint generally found in tumour and trauma cases.
  • UHMWPE ultra-high-molecular-weight-poly-ethylene
  • PEEK Poly ether ether Ketone
  • the present invention is to retain all the vasculature and the mobility by replacing the joint and femur side bone lost due to either trauma or cancer by a Distal Femur Total Knee Prosthesis with Self Limiting Small Angle Tibial-Femoral Rotation
  • Knee Prosthesis available presently can be classified into four categories. They are:
  • PCL Posterior Cruciate Ligament
  • US Patent No. 6,491 ,726 B2 on“POSTERIOR STABILIZED PROSTHETIC KNEE REPLACEMENT WITH BEARING TRANSLATION AND DISLOCATION PREVENTION FEATURES” relates to a prosthetic replacement knee joint which includes a tibial component, a femoral component, a bearing and a control arm.
  • the tibial component has a superior bearing surface and a conical recess extending into the superior bearing surface.
  • the bearing has an inferior surface slidably engaged with the superior surface of the tibial component and formed with a dovetailed groove therein.
  • the bearing also has a concave superior surface. A notch extends into the posterior extreme of the bearing.
  • the femoral component has a pair of convex arcuate condyles in articular bearing engagement with the superior surface of the bearing.
  • the femoral component also includes a posterior notch having a minor medial-lateral width at the inferior surface of the femoral component and a major width at more superior locations on the femoral component.
  • the control arm has a conical bearing rotatable positioned in the conical recess of the tibial component.
  • the control arm further has a dovetail guide slidably engaged in the dovetail groove of the bearing.
  • a post projects through the notch in the bearing and into the notch of the femoral component.
  • the post has medial and lateral projections that engage portions of the notch in the femoral component that define the major width thereof.
  • a mobile bearing knee prosthesis which may include an interface (e.g., a spherical radius interface) comprised of a concave superior surface on a tibial tray and a convex inferior surface on a tibial insert.
  • a mobile bearing knee prosthesis may include an interface (e.g., a spherical radius interface) comprised of a convex superior surface on a tibial tray and a concave inferior surface on a tibial insert.
  • a mobile bearing knee prosthesis may include a bi- concave interface (e.g., having a "wave” like surface geometry).
  • This "wave” like surface geometry may be at the second bearing (i.e., at the interface between a tibial insert and a tibial tray in the mobile bearing knee as opposed to the interface between the tibial insert and a femoral component).
  • US Patent Application No. 2011/0137425 Al on “TOTAL KNEE PROSTHESIS AND RANGE OF ELEMENTS FOR PRODUCING SAID PROSTHESIS” concerns a prosthesis comprising a femoral implant and a tibial implant equipped with anchoring rods, each anchoring rod not being integral with the corresponding implant and capable of being connected thereto, the prosthesis including therefor means for assembling each anchoring rod to the corresponding implant.
  • the invention is characterized in that the means for assembling each medullar anchoring rod to the corresponding implant are configured to allow a plurality of possible angular positions of that same anchoring rod relative to the implant in translation along an axis inscribed in the frontal plane, that is lateral, or in the sagittal plane, that is antero-posterior, of the implant.
  • US Patent No. 8,540,776 B2 on“TOTAL KNEE PROSTHESIS” relates to a total knee prosthesis.
  • This prosthesis includes a femoral implant including two condyles delimiting between them an intercondylar notch, a tibial implant intended to rest on the end of the tibia, and an articular insert interposed between the tibial implant and the femoral implant and the upper surface of which includes two glenoid cavities with an external profile congruent with the external profile of the condyles of the femoral implant and connected together through an interglenoidal connecting surface.
  • the intercondylar notch and the interglenoidal connecting surface have congruent contact surfaces which are inscribed in two mating hyperbolic paraboloids and the contact surface of the glenoid cavities have in a horizontal section an ovoid shape and its inclined point is located posteriorly to the line of larger width of the insert.
  • US Patent No. 9,289,304 B2 on “PROSTHESIS FOR PARTIAL AND TOTAL JOINT REPLACEMENT” relates to a prosthetic joint which is secured to the bones forming the original joint by utilizing strictly mechanical fasteners, for example, a threaded rod engaging a tapped intramedullary canal. Cross locking members may be provided. The need for bone cement is avoided.
  • the prosthetic joint may be used to replace one end of one bone forming the joint, utilizing the naturally occurring end of the other bone. Alternatively, both bone ends may be replaced with prosthetic joint portions. The decision to replace one or both bone ends may be made mid-surgery.
  • the prosthetic joint portions are secured together utilizing ligament reconstruction members made from portions of the patient's tendons or allograft tendons. A bearing forming the interface between the two joint portions is designed to wear in order to protect the remaining components from wear, and to be easily replaced in relatively simple future surgeries.
  • US Patent Application No. 2016/0100950 A1 on “TOTAL KNEE PROSTHESES AND METHOD FOR THE ASSEMBLY THEREOF” focuses on a method for assembling a total knee prosthesis wherein portions of femoral and tibial implants, which are referred to as common portions and are each attachable in a femur and in a tibia of a knee, respectively, are assembled, and interchangeable portions are selected for adjustable assembly onto said common portions for each implant, respectively, depending on the type of prosthesis desired, some for a first posterior stabilization assembly configuration, and the others for a second rotary hinge assembly configuration.
  • US Patent Application No. 2016/0158018 Al on “PROSTHESIS FOR PARTIAL AND TOTAL JOINT REPLACEMENT” relates to a prosthetic joint which is secured to the bones forming the original joint by utilizing strictly mechanical fasteners, for example, a threaded rod engaging a tapped intramedullary canal. Cross locking members may be provided. The need for bone cement is avoided.
  • the prosthetic joint may be used to replace one end of one bone forming the joint, utilizing the naturally occurring end of the other bone. Alternatively, both bone ends may be replaced with prosthetic joint portions. The decision to replace one or both bone ends may be made mid-surgery.
  • the prosthetic joint portions are secured together utilizing ligament reconstruction members made from portions of the patient's tendons or allograft tendons. A bearing forming the interface between the two joint portions is designed to wear in order to protect the remaining components from wear, and to be easily replaced in relatively simple future surgeries.
  • US Patent No. 9,387,084 B2 on “ANTERIOR STABILIZED PCL RETAINING TOTAL KNEE PROSTHESIS” highlights a knee prosthesis that includes a tibial component and femoral component.
  • the tibial component includes an articular surface, a posterior portion and an anterior portion.
  • the posterior portion includes a recess for receipt of a posterior cruciate ligament.
  • the anterior portion includes a post extending therefrom.
  • the post includes a posterior surface.
  • the femoral component includes a condylar portion and an intercondylar portion.
  • the intercondylar portion includes a posterior recess for receipt of the posterior cruciate ligament, a cam, and an engagement recess for receipt of the post.
  • the cam includes a sliding surface and is disposed between the engagement recess and posterior recess.
  • the sliding surface of the cam slides along the posterior surface of the post for restricting anterior subluxation of a femur bone when the articular surface and the condylar portion articulates through flexion of a knee joint.
  • US Patent Application No. 2016/0228254 Al on“IMPLANT SET HAVING MODULARITY WITH CONFORMITY FOR TOTAL KNEE REPLACEMENT” discloses an implant set having modularity with conformity for total knee replacement.
  • the set having a femoral metal component, Tibial Component with locked tibial Insert therein and Patella to provide the exact conformity of combination of femoral component and tibial component.
  • each of the Femoral component to tibial insert pair there will be at least three sizes of tibial components available, namely, a minus size tibial component, a standard tibial component, and a plus size tibial component; the dimensions of the locking mechanism will be same on all the three sizes, i.e. on minus size, standard size, and plus size.
  • the present application is for a Distal Femur Total Knee Prosthesis with Self Limiting Small Angle Tibial-Femoral Rotation implant which ensures patient comfort by allowing large flexion angles coupled with certain amount of tibial-femoral rotation to replicate, as far as possible, human motion while ensuring minimal wear.
  • a Distal Femur Total Knee Prosthesis with Self Limiting Small Angle Tibial-Femoral Rotation implant which ensures patient comfort by allowing large flexion angles coupled with certain amount of tibial-femoral rotation to replicate, as far as possible, human motion while ensuring minimal wear.
  • the main object of the invention is to find an innovative solution to malignant bone tumours around Knee, especially involving resection of articulating knee joint as mega-prosthesis.
  • Another object of this invention is to develop a Distal Femur knee Prosthesis which attempts to mimic, as far as possible, the natural knee joint.
  • An additional object of this invention is to develop an innovative prosthesis which enables the transfer of all the load from the upper leg to the lower leg without shear while retaining all the possible degrees of freedom (i.e., Flexion Extension and Tibial Rotaion), thereby reducing the strain in the leg muscles.
  • Yet another object of this invention is to ensure that the Distal Femur Knee prosthesis fills the mega-bone defect as conformally as possible to real knee joint in terms of function and sizes.
  • a further object of this invention is to provide a cost effective high quality Tumour Knee Prosthesis with a Flexion Extension of 0°-l50° and Tibial Rotation up to ⁇ 5°.
  • Yet another objective of this invention is to design a High quality prosthesis using the existing bio-compatible raw materials such as CoCr alloy, Ti64 alloy and UHMWPE.
  • Figure 1(a) Assembly view of the complete prosthesis.
  • Figure 1(b) An additional view of the complete prosthesis showing the valgus/varus angle between the tibial and the femoral axis
  • Figure 3(b) Sectional View of Section AA of assembly shown in Fig. 1 showing the features that provides self-limiting small angle tibial-femoral rotation .
  • a Distal Femur Total Knee Prosthesis with Self Limiting Small Angle Tibial-Femoral Rotation consisting: (a central pin assembly having a pin shaft (37) containing a spherical protuberance (38) at the central portion, a central UHMWPE bush (39), medio-lateral lock plate (41), condylar bushes (42, 43) and circlips (44); (b) a tibial assembly comprising a tibial stem (1), a tibial tray (2) and a tibial Ultra-high-molecular-weight-poly-ethylene (UHMWPE) seat/ tibial poly (3); and (c ) a femoral assembly consisting of femoral condyle (4), femoral extension piece (5), femoral collar (6), and femoral stem (7).
  • a central pin assembly having a pin shaft (37) containing a spherical protuberance (38) at the central portion, a
  • the present invention describes a“Distal Femur Total Knee Prosthesis With Self Limiting Small Angle Tibial-Femoral Rotation” (Fig.1), which consists of three major component assemblies, namely a tibial assembly (Fig.2), a central pin assembly (Fig. 3(a)) and a femoral assembly (Fig. 4)
  • Tibial Stem (1) is further illustrated in Fig. 5. It has contoured tibial stem projection (11) at one end, contoured tibial stem body (10) and a threaded tibial stem head (9) at the other end. This tibial stem head is threaded to ensure rigid fitment with tibial tray. From this threaded end, the stem body (10) tapers down to a size that is suitable for inserting into the tibia ending in a long rounded end cylindrical shape with rectangular tibial stem projections (1 1). The projections and groves between the projections aid in ensuring proper adhesion with the tibia.
  • Tibial Tray (2) as shown in Fig. 6, has a tibial stem support (12) which is a ribbed cylindrical projection protruding from the bottom of the tibial tray, with a threaded hole (13) into which the threaded tibial stem head (9) fits.
  • the ribs (14) act as stiffeners to provide enhanced strength and also to ensure a firm grounding with the tibial cancellous bone.
  • the tibial tray has, projecting from its top surface, a round headed central tibial post (19). The central pin assembly passes through a central hole (20) in the rounded head of this post (19).
  • the tibial tray also has three projections, known as anterior anchor (24), medio-posterior anchor (25), and latero-posterior anchor (26) which serve as anchors to precisely locate and firmly hold the UHMWPE seat in place while doing the articulating motion.
  • Figure 7 refers to UHMWPE seat.
  • the UHMWPE seat has a cavity (28) at the centre to accommodate the tibial central post and a contoured projection (29) on the anterior side which exactly conforms to trochlear surface of the femoral assembly (femoral condyle). This projection (29) restricts the anterior movement (hyperextension) in flexion-extension.
  • FIG. 3(a) shows the various components of central pin assembly.
  • the central pin assembly consists of a central pin (37) which is a shaft having a spherical protuberance (38)at the centre.
  • This central pin at its extreme ends, passes through two condylar bushes (42, 43), - which are UHMWPE bushes that fit inside the holes of the femoral condyles (55, 56) - and at the centre passes through a central bush (39), this central bush also being made of UHMWPE, and fitting in the hole (20) the tibial post.
  • the central UHMWPE bush fitted inside the tibial post is machined in such a way as to provide, as shown in Fig. 3(b), freedom of movement of ⁇ 5° to the spherical protuberance (38) in the axis pin, giving a freedom of movement akin to mobile bearings. This movement has a positive lock and limits to ⁇ 5°.
  • Femoral stem has a self-holding taper at one end (65) which fits in the tapered hole (57) of the extension piece (5) or the tapered hole of the femoral condyle (46). Beyond this taper, the stem is reversed tapered (66) which fits in the tapered central bore (61) of the femoral collar. Further to this reversed tapered body, the stem ends up in a cylindrical rod with rectangular cavities (67) grooved on its periphery.
  • Femoral condyle (Figure 8), comprising of condyles, inter-condylar notch annotated/listed in table 4, as condylar cavity (54)and the trochlear surface also referred to as patellar surface (48) which merges with the inter-condyle notch (54).
  • the condyles have a profile exactly conforming to the requirements for the articulation and have holes (55, 56) for the central pin assembly.
  • the terminologies used to denote directions here are guided by the position of the implant in a human body with the human body in a standing position facing the viewer.
  • the upper and lower (or bottom) directions indicate direction pointing towards head and towards feet respectively.
  • Another term frequently used in succeeding paragraphs for lower direction is distal.
  • the direction towards the viewer is called anterior and direction pointing towards the back of the human body is called posterior.
  • the inner side of the knee joint that is, the side pointing towards the vertical centre line of the body (an imaginary vertical line passing between the legs) is called medial and the side pointing outwards towards the hands is called lateral.
  • Fig 1 (b) shows an additional view of the assembly showing the valgus/varus angle of 5°between the tibial and femoral axis.
  • This invention is essentially made up of a tibial assembly shown in Fig. 2, a central pin assembly the components of which are shown in Fig. 3(a) and a femoral assembly shown in Fig. 4. These sub-assemblies and the components that these assemblies are made up of are dealt with in the subsequent paragraphs.
  • the tibial assembly shown in Fig. 2 comprises of a tibial stem(l) shown in Fig. 5, a tibial tray (2) shown in Fig. 6, and a tibial UHMWPE seat also called tibial poly (3) shown in Fig.7.
  • the tibial stem is shown in Fig 5.
  • One end of this stem referred to as tibial stem head (9) is threaded to ensure rigid fitment with the tibial tray.
  • the stem body (10) tapers down to a size that is suitable for inserting into the tibia, ending in a long rounded end cylindrical shape with rectangular tibial stem projections(l l). The projections together with the grooves between the projections aid in ensuring proper adhesion with the tibia.
  • Fig 6 shows the tibial tray.
  • the tibial tray is fixed to the tibia through the tibial stem.
  • a tibial stem support which is a cylindrical projection (12), protruding from the bottom of the tibial tray, containing within it a closed ended threaded hole(l3).
  • the threaded tibial stem head (9) fits into this threaded hole (13).
  • Ribs, also called stiffeners (14) provide additional strength to the tibial stem support and also provide positive anchoring in the cancellous bone of tibia.
  • the external profile of the tray comprises of the anterior profile (15), the posterior profile (16), the medial profile (17) and the lateral profile (18) and these profiles, together, largely mimic the natural anatomical features.
  • a central tibial post with rounded head (19) juts out perpendicularly.
  • the rounded head of this post has a hole, the central hole (20), passing through it in the medio-lateral direction.
  • This hole contains a specially contoured recess (21) at the bottom portion. This recess serves as locating and anchoring point for placing the central UHMWPE bush (39) (to be discussed later as part of central pin assembly) which fits inside the central hole (20).
  • this central post there are two rectangular slots with rounded corners, namely the medial cavity (22) and the lateral cavity (23).
  • Three L-shaped anchors called the anterior anchor (24), the medio-posterior anchor (25) and the latero-posterior anchor (26), are provided on the periphery at appropriate locations as shown in the drawing.
  • These anchors together with the medial cavity (22) and the lateral cavity (23) ensure precise location and rigid immovable fixing of the tibial UHMWPE seat (also called tibial poly) to the tibial tray.
  • the anterior anchor is shaped like a‘L’ hook and the UHMWPE seat needs to be first slid at an angle and inserted into this hook and then pressed down for proper seating and alignment.
  • Fig 7 shows the tibial poly (also called as tibial seat or UHMWPE seat) made out of ultra-high-molecular-weight-poly-ethylene (UHMWPE).
  • the anterior top surface of this seat has a contoured projection jutting out (27) and the contour profile of the surface of this projection matches with the mating surface profile of the distal femoral condyle.
  • the seat has a rectangular slot (28) cut in the middle to accommodate the tibial post.
  • the top surface on either side of the slot are slightly contoured to match the mating profile in the femoral condyle.
  • the profiles on the anterior (29), medial (30) and lateral(3 l) sides of the seat match with the profiles of the tibial tray.
  • the seat On either side of the earlier mentioned rectangular slot (28), the seat has two projections (32, 33) of rectangular shape with rounded comers protruding out from its bottom surface. These protrusions get located in the medial cavity (22) and the lateral cavity (23) respectively and help in proper alignment of the tibial poly with the tibial tray.
  • the tibial poly in addition has appropriately shaped anterior anchor cavity (34), medial anchor cavity (35) and lateral anchor cavity (36) which match respectively with the anterior anchor (24), the medio-posterior anchor (25) and the latero-posterior anchor (26) of the tibial tray and help in rigidly fixing the tibial poly to the tibial tray.
  • Fig 3(a) shows the different components of the central pin assembly.
  • This pin contains the central pin (or shaft)(37).
  • This pin has a spherical protuberance (38) at its centre.
  • the radius of this spherical protuberance can be controlled in such a way that a femoro-tibial rotation of about ⁇ 5° can be achieved as shown in Fig. 3(b).
  • the diameter of the pin is stepped down at both the ends.
  • the central bush (39) made of UHMWPE, at its bottom, has a projection (40) which securely sits in the contoured recess (21) in the tibial tray.
  • the spherical protuberance (38) of the pin is located inside this central bush in the final assembly.
  • FIG. 8 shows different views of femoral condyle.
  • a tapered hole with self-holding morse taper (46) for fixing the femoral extension piece or the femoral stem.
  • two teeth like projections (47) are provided which fix and lock the rotational movement between the femoral condyle and the femoral extension piece or the femoral collar.
  • the tapered hole (46) is suitably angled as shown in Fig.l (b) to incorporate the specified varus/valgus requirements.
  • the trochlear surface (48) also called patellar surface
  • the profiles of the medial condylar surface (49) as well as the lateral condylar surface (50) have been designed to mimic natural anatomical features.
  • the anterior condylar surface (51) and the bottom condylar surface (52) have been designed with some amount of flatness which together with contoured projection of tibial poly (27) leads to self- limiting of hyper extension i.e. flexion below 0°.
  • the mating portion of the condyle which mates with the tibial UHMWPE seat has a cylindrical contact condylar profile(53).
  • the surface of the inter-condylar notch (54) in between the medial condylar surface and the lateral condylar surface smoothly merges at the bottom with the trochlear surface /Patellar surface (48).
  • Both the medial and the lateral condyles contain co-axial holes (55, 56). These holes within them contain seating grooves for locating, fixing and seating of UHMWPE condylar bushes (42, 43).
  • Fig. 9 shows the Femoral Extension Piece.
  • This is a modular piece designed to accommodate the various tumour resection lengths since the extent of damaged knee part varies with every patient.
  • it has a self-holding morse tapered cavity(57) with two teeth like projection pins jutting out on either side(58), the combined profile being exactly identical to the one that is available at the top of the femoral condyle (46 and 47).
  • At the bottom, it has a self-holding morse tapered male end (59) which goes and securely sits inside the tapered hole (46) of femoral condyle or, if required, a similar cavity in an additional extension piece (57).
  • Two recesses, on either side of this morse tapered male portion (60) matching the tooth like projections on the femoral condyle (47) or the extension piece (58) provide secure rotational lock.
  • Fig.10 shows the femoral collar.
  • This has a tapered central bore ((61), its taper matching the taper of the femoral stem (66) (which is being dealt with in the succeeding paragraph).
  • On the bottom are two recesses (62) which match the projections on the top of the femoral condyle (47) or the femoral extension piece (58).
  • At the top of the collar on the outside, there are specialized serrations (63). These serrations are coated with Hydroxyapatite coating in order to ensure integration/assimilation, (in due course of time), of the femoral assembly with the femoral bone since a proper integration would greatly reduce the chances of the stem/femoral assembly getting loosened.
  • a laser mark on the surface (64) denotes the assembly with femoral stem.
  • the faces of the collar are slightly inclined to facilitate assembly-disassembly of the collar from the joint.
  • Fig 1 1 shows the femoral stem.
  • This stem has a tapered (self-holding taper) end (65) which securely fits into the tapered hole (46) on the top of femoral condyleor on top of the femoral extension piece (57).
  • Above the tapered end is the femoral stem tapered (66) in the reverse direction.
  • Top portion of this body ends in a thinner rod having slots cut in them as femoral stem cavities (67) which aid in securing the stem to the femur bone’s intramedullary canal using cement.
  • the femoral condyle is supplied with the condylar bush and circlip already in place.
  • the central bush is inserted using specially designed armamentarium.
  • the central pin assembly is inserted subsequently and is locked in place using lock plate.
  • the opened end condylar bush is inserted and its position is locked using circlip.
  • the design also ensures easy dis-assembly.
  • the matching profiles of Tibia poly and the femoral condyle preclude any femuro-tibial movement.
  • the spherical protuberance in the central axis pin allows some amount of femoro-tibial rotation and the extent of allowable rotation can be controlled by the design and size of the spherical protuberance.
  • the instant invention comprises of several different parts used in such a way to achieve 0°-150° flexion and with tibial-femoral rotation upto ⁇ 5°
  • the assembly has been subjected to standard testing conditions with applied load of 250 kg and after 10 million cycles of testing, the tested samples of“Distal Femur Total Knee Prosthesis With Self Limiting Small Angle Tibial-Femoral Rotation” exhibited wear losses of about 250 microns and weight loss of about l lOmg in the UHMWPE components. This corresponds to medio-lateral play due to wear of approximately 0.5 mm and femoral tibial rotation of about ⁇ 8°.
  • Table 2 Wear & Surface Roughness of UHMWPE components (TibialUHMWPE Seat and Central Bush)
  • Distal Femur Total Knee Prosthesis with Self Limiting Small Angle Tibial- Femoral Rotation comprises of several different components used in such a manner so as to function as desired.
  • a complete list of various components use in the instant tumour knee prosthesis is given in Table 4 as follows:

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une prothèse totale du genou pour fémur distal à rotation tibiale-fémorale à petit angle auto-limitante, comprenant : un ensemble broche centrale possédant une tige (37) de broche contenant une protubérance sphérique (38) au niveau de la partie centrale, une emboîture centrale en PE-UHPM (39), une plaque de verrouillage médio-latérale (41), des bagues condyliennes (42, 43) et des anneaux élastiques (44) ; (b) un ensemble tibial comprenant une tige tibiale (1), un plateau tibial (2) et un siège tibial (3) en polyéthylène à ultra haut poids moléculaire (PE-UHPM) ; et (c) un ensemble fémoral constitué d'un condyle fémoral (4), d'une pièce d'extension fémorale (5), d'un collier fémoral (6) et d'une tige fémorale (7).
PCT/IN2018/050244 2018-01-25 2018-04-23 Prothèse totale du genou pour fémur distal à rotation tibiale-fémorale à petit angle auto-limitante Ceased WO2019145965A1 (fr)

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Cited By (6)

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Publication number Priority date Publication date Assignee Title
CN112741714A (zh) * 2021-01-20 2021-05-04 北京积水潭医院 一种可延长下肢关节假体
CN113069246A (zh) * 2021-03-31 2021-07-06 北京市春立正达医疗器械股份有限公司 一种双动膝关节假体
CN114867433A (zh) * 2019-12-16 2022-08-05 沃尔德马连接两合公司 关节假体
CN115349984A (zh) * 2022-08-08 2022-11-18 山东威高骨科材料股份有限公司 铰链式3d打印人工踝关节假体
WO2023051889A1 (fr) * 2021-09-28 2023-04-06 Hafez Mahmoud Alm El Din Méga-écarteur pour perte osseuse grave et tumeur
CN120585524A (zh) * 2025-05-09 2025-09-05 北京力达康科技有限公司 一种单踝关节临床手术表面置换系统

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114867433A (zh) * 2019-12-16 2022-08-05 沃尔德马连接两合公司 关节假体
CN112741714A (zh) * 2021-01-20 2021-05-04 北京积水潭医院 一种可延长下肢关节假体
CN112741714B (zh) * 2021-01-20 2023-06-20 北京积水潭医院 一种可延长下肢关节假体
CN113069246A (zh) * 2021-03-31 2021-07-06 北京市春立正达医疗器械股份有限公司 一种双动膝关节假体
WO2023051889A1 (fr) * 2021-09-28 2023-04-06 Hafez Mahmoud Alm El Din Méga-écarteur pour perte osseuse grave et tumeur
CN115349984A (zh) * 2022-08-08 2022-11-18 山东威高骨科材料股份有限公司 铰链式3d打印人工踝关节假体
CN120585524A (zh) * 2025-05-09 2025-09-05 北京力达康科技有限公司 一种单踝关节临床手术表面置换系统

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