WO2023006566A1 - Moyen de fixation pour prothèse - Google Patents

Moyen de fixation pour prothèse Download PDF

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Publication number
WO2023006566A1
WO2023006566A1 PCT/EP2022/070467 EP2022070467W WO2023006566A1 WO 2023006566 A1 WO2023006566 A1 WO 2023006566A1 EP 2022070467 W EP2022070467 W EP 2022070467W WO 2023006566 A1 WO2023006566 A1 WO 2023006566A1
Authority
WO
WIPO (PCT)
Prior art keywords
fixing means
prosthesis
bone
quiver
over
Prior art date
Application number
PCT/EP2022/070467
Other languages
German (de)
English (en)
Inventor
Norbert Meier
Original Assignee
mechamed GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by mechamed GmbH filed Critical mechamed GmbH
Priority to EP22757219.5A priority Critical patent/EP4376773A1/fr
Publication of WO2023006566A1 publication Critical patent/WO2023006566A1/fr

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Classifications

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    • A61F2/00Filters 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
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    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3609Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3609Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3625Necks
    • A61F2002/3631Necks with an integral complete or partial peripheral collar or bearing shoulder at its base
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3609Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/365Connections of heads to necks

Definitions

  • the invention relates to a fixation means for a prosthesis, in particular for a thigh prosthesis, equipped with a prosthesis anchor and having at least one peripheral contact surface, by means of which the fixation means can be fixed in a recess of a bone. Furthermore, the invention relates to a prosthesis with such a fixation means.
  • Fixing means of this type for fixing a prosthesis in a bone, for example the femur, are already widely used and are therefore part of the prior art.
  • human bone is made up of two types of bone: a compact, solid outer layer (compact bone) and a spongy inner zone (spongiosa).
  • the spongiosa consists of bone trabeculae between which the blood-forming marrow tissue is embedded. At the ends of the long bones (epiphyses) the spongiosa dominates, in the middle (diaphysis) the compact bone.
  • the bone trabeculae of the spongiosa show an arrangement that corresponds to the course of the main stress lines that occur in the bone during compressive and tensile loads. Similar to a three-dimensional framework, a maximum of strength is achieved with a minimum of substance.
  • Femoral components can be anchored according to various principles. Intramedullary stem anchoring is used most frequently, in which the prosthesis stem is cemented or cement-free in the medullary cavity of the femoral stem.
  • the removal of the spongiosa is to be regarded as a non-physiological local disturbance in the sense of the formation of a defect, which impairs the ability to adapt to loads and, above all, to age-related factors.
  • a cementless hip joint endoprosthesis with a hollow shaft has become known under the designation spongiosa hip joint endoprosthesis, the interior of which is permeable via openings to the medullary cavity.
  • the interior is filled with spongy bone before implantation and then the prosthesis shaft is driven into the medullary cavity of the femur.
  • Improved integration of the implant is to be achieved through the ingrowth of bone into the interior of the prosthesis or through reorganization of the introduced spongiosa.
  • Another method is anchoring the artificial femoral head through the neck of the femur according to the tension screw principle.
  • This form of anchoring is particularly favored in younger patients, since the medullary cavity of the femoral shaft is not affected and subsequent intramedullary shaft anchoring when changing a prosthesis is possible without any problems.
  • EP 1 168988 B1 discloses a prosthesis with a shaft which penetrates the bone and is exposed on the outside of the bone.
  • EP 0270863 A1 relates to a hip joint prosthesis for cementless implantation in the medullary cavity of the femur, the shaft being designed as a single or multi-threaded spiral. This is intended to reduce the tension introduced into the bone in the shaft area physiologically favorable values and the shear forces and relative movements at the interface between shaft and bone are minimized.
  • EP 0547354 A1 discloses an adjustable prosthesis head that carries the joint ball and is adjustable by means of a link element, a supporting body and a threaded bolt and is connected to a shaft fixed in the femur.
  • a limiting element is provided that absorbs the forces and is reset after they occur.
  • DE 10308338 B4 relates to a bone dowel that can be inserted into a bore in the bone and into which a screw can be screwed.
  • the dowel jacket On the outer surface, the dowel jacket has a longitudinal slot and three longitudinal ribs arranged at an angle of 90° to prevent rotation.
  • DE 20305713 U1 also relates to a bone dowel with a longitudinal slot for fixing a screw in the bone, which has longitudinal ribs and circumferential ribs which are designed with sharp edges or barb-like and can dig into the bone tissue.
  • RU 2661 019 C1 describes a dental prosthesis which, in the use position, is spread and clamped over its entire length in the recess of the bone.
  • the invention is based on the object of creating an endoprosthesis of the type mentioned at the outset, which ensures that the physiology of the bone marrow space including the spongiosa is preserved and thus favorable anatomical conditions during revision operations and optimal adaptation options to age-related bone changes and an optimal physiological introduction of force as well as an enlarged contact surface for the Growth of bone material and an individual adjustment in terms of orientation and position in the bone allows.
  • This object is achieved according to the invention with a fixation means of a prosthesis according to the features of claim 1.
  • the further development of the invention can be found in the dependent claims.
  • a fixing means which has a socket that encloses the contact surface at least in sections and is in particular elastically or flexibly deformable, which extends parallel to the main extension of the fixing means in the axial direction, with the socket in the use position extending uniformly over its entire length in opposite radial directions Directions with a matching or nearly matching amount concentric to the clamping axis is expanded or spread.
  • the fixing agent according to the invention enables an endoprosthesis to be introduced while preserving the spongy structures, so that the metabolic biology is not disturbed and the blood flow conditions are not significantly changed.
  • preserving the physiology of the bone marrow space, including the intertrochanteric spongiosa favorable anatomical conditions are created for revision operations and optimal adaptation options to age-related bone changes.
  • the fixing means achieves secure anchoring of the contact surface provided with the peripheral quiver, so that the surfaces of the quiver that are supported on the spongiosa are significantly enlarged and, in particular, do not develop a wedge effect during fixation.
  • the quiver according to the invention the relative axial movement of different contact surfaces is not transmitted to the surrounding cancellous structure. Rather, the contact surfaces slide on the inside of the quiver without displacing it relative to the cancellous structures. Since the quiver also has sufficient inherent rigidity, the peripheral radial displacement always takes place over the entire axial extent of the quiver due to the spreading effect, namely synchronously in opposite directions.
  • the quiver not only achieves a far better, in particular almost homogeneous distribution of the compressive forces introduced into the spongy structures, but at the same time a transverse displacement or a tilting movement of the entire fixation means and consequently the prosthesis is reliably avoided. Inaccuracies in the orientation and position of the prosthesis are thus significantly reduced. It has been shown that in many cases pre-cutting or rasping is not necessary. Rather, the fixative can be driven directly into the bone without any major preliminary work.
  • This procedure offers decisive surgical advantages, in particular a considerable time saving and a reduction in the risk of infection.
  • the surface structure of the quiver as well as its outer cross-sectional shape can be adjusted as desired, in particular to the patient, an enlarged contact surface for the growth of bone material and, on the other hand, the prerequisite for an individual adaptability of the endoprosthesis to the respective bone shape are made possible with little means .
  • the solution according to the invention is based on the knowledge that, contrary to the prejudice in the professional world, the fixing agent finds sufficient support in the spongy structure and can easily meet the requirements for the holding forces.
  • the prerequisite for this is the parallelism of the spread of the quiver over the entire length and synchronously with the central longitudinal axis of the fixing means.
  • the attachment of the prosthesis to the femur of a patient which is possible due to the shape of the endoprosthesis according to the invention while largely sparing the spongiosa, creates a secure physiological, ie proximal, force application, with the spongy structures offering an extremely firm hold and allowing the transmission of high compressive forces.
  • the quiver has a slotted sleeve with an area in which a fold, a fold, a deformable insert and/or a slot is provided, which preferably extends parallel to the slotted sleeve over the entire extent of the clamping axis, so that the quiver can be either perforated or closed on the circumference. Due to the spreading effect of the fixing means, which is equipped, for example, with wedge sleeves, the quiver is thus expanded radially along its longitudinal extent, with a concentric cross-sectional shape being retained in every phase of the spreading process.
  • the quiver could, at least in sections, consist of a perforated material, for example a perforated metal sheet or a lattice, in order to encourage ingrowth.
  • a perforated material for example a perforated metal sheet or a lattice
  • Another, likewise particularly advantageous embodiment is also achieved in that the quiver is made of a plastic material, at least in sections consists, which facilitates the introduction of the fixative into the bone by a low frictional resistance.
  • the holder has a rib-like and/or groove-like shape running at least in sections parallel to the longitudinal axis.
  • the longitudinal formations are driven into the cancellous structures during the introduction of the fixative and wedge there without disturbing the cancellous tissue. Rather, the formations displace the spongy tissue, which can then continue to fulfill its physiological function.
  • the formations thereby prevent an undesired rotation about the central longitudinal axis and thus an undesired deflection from the predetermined angular position.
  • a plurality of the in particular rib-shaped formations are preferably arranged evenly distributed on the circumference of the quiver or the slotted sleeve, so that torques acting on the prosthesis can be effectively absorbed.
  • the rib-shaped formations preferably have a cross-sectional shape in the cross-sectional plane of the slotted sleeve, which becomes narrower or tapers in the course of the radial extension and in particular tapers to a point and thus promotes the penetration of the formations into the cancellous tissue.
  • the quiver extends in the axial direction with its distal end area beyond the length of the wedge sleeves with a projection. This avoids direct contact of the wedge sleeves with the spongy tissue, even in the end area of the contact surface. Because the quiver has a flexible surface, for example, the material of the quiver is optimally suited as a contact surface with the cancellous tissue, with wedge effects, in particular due to edges or projections, being avoided in contact with the cancellous tissue.
  • the quiver can be closed at its distal end section, which is surrounded by the spongy structure, in order to create a closed cover for the contact surface by means of a bottom surface. This means that the connection can be released again if necessary because the spongy tissue does not grow into the contact surface. To separate, the tension is released and the fixative off taken from the quiver. This is then removed from the spongy structures, possibly destructively.
  • the quiver In order to achieve the best possible transfer of force from the quiver to the spongy structures, it has already proven to be particularly promising if the quiver is made of a flexible material and can therefore optimally mold to the existing structures. If necessary, this effect can also be supported by a suitable, for example knob-like surface structure.
  • the invention permits various embodiments. To further clarify its basic principle, one of them is shown in the drawing and is described below. This shows in
  • FIG. 1 shows a side view of a fixing means according to the invention
  • Figure 2 is a sectional side view of the fixture shown in Figure 1;
  • Fig. 3 is a perspective view of the fixing means
  • Fig. 4 is a sectional side view of the fixative used in a femur.
  • a fixing means 2 according to the invention intended for fixing a prosthesis in a bone 1 is explained in more detail below with reference to FIGS.
  • the fixing means 2 has a prosthesis anchor 3 for coupling to a functional section (not shown) of an artificial joint and at least two wedge sleeves 4 that are movable relative to one another and form the contact surfaces of Figure 2 can be seen.
  • the wedge sleeves 4 are enclosed on the peripheral side by a quiver 7, which extends coaxially to the clamping axis 5 in the axial direction over both wedge sleeves 4 .
  • the fixing means 2 has this one than one Slot sleeve 8 running quiver 7 with a continuous longitudinal slot 9 and consists of a plastic material. Rib-shaped formations 10 running parallel to the clamping axis 5 can only be seen in outline in FIG.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (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 se rapporte à un moyen de fixation (2) qui est conçu pour une prothèse, en particulier pour une prothèse fémorale, et qui est équipé d'un ancrage de prothèse. Le moyen de fixation présente au moins deux surfaces de contact qui peuvent être déplacées l'une par rapport à l'autre et qui sont déviées radialement au moyen d'un arbre de tension (5) et sont ainsi fixées dans un évidement de l'os (1). L'objectif de l'invention est d'obtenir une surface d'appui fiable et porteuse du moyen de fixation à l'intérieur de la structure spongieuse (6) de l'os. À cet effet, les surfaces de contact sont entourées de manière circonférentielle par un support tubulaire 57) qui s'étend dans la direction axiale coaxialement à l'arbre de tension. Ainsi, le support tubulaire n'est pas en forme de coin, comme c'est le cas avec les chevilles osseuses connues, mais s'étale plutôt sur toute son étendue longitudinale de manière synchrone et concentrique par rapport à l'arbre de tension, ce qui permet d'obtenir une introduction optimale d'une force dans les structures spongieuses.
PCT/EP2022/070467 2021-07-28 2022-07-21 Moyen de fixation pour prothèse WO2023006566A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP22757219.5A EP4376773A1 (fr) 2021-07-28 2022-07-21 Moyen de fixation pour prothèse

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021119574.8A DE102021119574B4 (de) 2021-07-28 2021-07-28 Fixiermittel für eine Prothese
DE102021119574.8 2021-07-28

Publications (1)

Publication Number Publication Date
WO2023006566A1 true WO2023006566A1 (fr) 2023-02-02

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PCT/EP2022/070467 WO2023006566A1 (fr) 2021-07-28 2022-07-21 Moyen de fixation pour prothèse

Country Status (3)

Country Link
EP (1) EP4376773A1 (fr)
DE (1) DE102021119574B4 (fr)
WO (1) WO2023006566A1 (fr)

Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0270863A1 (fr) 1986-11-17 1988-06-15 Roger Prof. Dr.-Ing. Thull Prothèse de la hanche à implanter
DE3838388A1 (de) * 1988-11-11 1990-05-17 Thomas Dr Med Pfeifer Befestigungsvorrichtung
EP0547354A1 (fr) 1991-12-17 1993-06-23 Dr.Ing.h.c. F. Porsche Aktiengesellschaft Endoprothèse réglable pour l'articulation de la hanche
DE4325714A1 (de) * 1993-07-30 1995-02-02 Schmidt Ramsin Eckhard Dr Med Hüftprothese
US6319255B1 (en) * 1996-12-18 2001-11-20 Eska Implants Gmbh & Co. Prophylactic implant against fracture of osteoporosis-affected bone segments
DE20305713U1 (de) 2003-04-09 2003-07-10 Willmen Hans Rainer Knochendübel
EP1168988B1 (fr) 1999-02-19 2006-01-18 James B. Grimes Prothése osseuse
DE10308338B4 (de) 2003-02-27 2006-06-14 Gausepohl, Thomas, Dr. Knochendübel
WO2008154762A1 (fr) * 2007-06-18 2008-12-24 Roderic Alexander Frei Élément d'ancrage pour endoprothèses dans des os longs
EP1847238B1 (fr) * 2006-04-18 2009-09-09 Plus Orthopedics Italy Srl Prothèse fémorale
US8968415B2 (en) * 2012-02-07 2015-03-03 Biomet Manufacturing, Llc Implant fixation device
RU2661019C1 (ru) 2017-01-13 2018-07-11 Общество С Ограниченной Ответственностью "Инновационный Стоматологический Центр "Нано-Дент" Зубной имплантат и комплект для дентальной имплантации
DE102020128512B3 (de) * 2020-10-29 2021-11-18 mechamed GmbH Prothesenanker

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0270863A1 (fr) 1986-11-17 1988-06-15 Roger Prof. Dr.-Ing. Thull Prothèse de la hanche à implanter
DE3838388A1 (de) * 1988-11-11 1990-05-17 Thomas Dr Med Pfeifer Befestigungsvorrichtung
EP0547354A1 (fr) 1991-12-17 1993-06-23 Dr.Ing.h.c. F. Porsche Aktiengesellschaft Endoprothèse réglable pour l'articulation de la hanche
DE4325714A1 (de) * 1993-07-30 1995-02-02 Schmidt Ramsin Eckhard Dr Med Hüftprothese
US6319255B1 (en) * 1996-12-18 2001-11-20 Eska Implants Gmbh & Co. Prophylactic implant against fracture of osteoporosis-affected bone segments
EP1168988B1 (fr) 1999-02-19 2006-01-18 James B. Grimes Prothése osseuse
DE10308338B4 (de) 2003-02-27 2006-06-14 Gausepohl, Thomas, Dr. Knochendübel
DE20305713U1 (de) 2003-04-09 2003-07-10 Willmen Hans Rainer Knochendübel
EP1847238B1 (fr) * 2006-04-18 2009-09-09 Plus Orthopedics Italy Srl Prothèse fémorale
WO2008154762A1 (fr) * 2007-06-18 2008-12-24 Roderic Alexander Frei Élément d'ancrage pour endoprothèses dans des os longs
US8968415B2 (en) * 2012-02-07 2015-03-03 Biomet Manufacturing, Llc Implant fixation device
RU2661019C1 (ru) 2017-01-13 2018-07-11 Общество С Ограниченной Ответственностью "Инновационный Стоматологический Центр "Нано-Дент" Зубной имплантат и комплект для дентальной имплантации
DE102020128512B3 (de) * 2020-10-29 2021-11-18 mechamed GmbH Prothesenanker

Also Published As

Publication number Publication date
EP4376773A1 (fr) 2024-06-05
DE102021119574B4 (de) 2024-03-07
DE102021119574A1 (de) 2023-02-02

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