WO2020161374A1 - Partial prosthesis for the scaphoid bone - Google Patents

Partial prosthesis for the scaphoid bone Download PDF

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Publication number
WO2020161374A1
WO2020161374A1 PCT/ES2020/070078 ES2020070078W WO2020161374A1 WO 2020161374 A1 WO2020161374 A1 WO 2020161374A1 ES 2020070078 W ES2020070078 W ES 2020070078W WO 2020161374 A1 WO2020161374 A1 WO 2020161374A1
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WIPO (PCT)
Prior art keywords
prosthesis
scaphoid
bone
proximal
distal
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PCT/ES2020/070078
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Spanish (es)
French (fr)
Inventor
Patricia GÓMEZ BARBERO
Daniel MONTANER ALONSO
José Luis RODRIGO PÉREZ
Original Assignee
Universitat De València
Fundacion Para El Fomento De La Investigación Sanitaria Y Biomédica De La Comunitat Valenciana
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Publication of WO2020161374A1 publication Critical patent/WO2020161374A1/en

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Classifications

    • 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
    • A61F2/42Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • 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
    • A61F2/28Bones

Definitions

  • the present invention relates to a partial scaphoid bone prosthesis, adapted to replace, after exeresis of a proximal portion of the actual scaphoid, said removed proximal portion, thereby keeping at least the distal pole of the entire scaphoid bone undamaged and furthermore with integrity of the scapho-trapezius-trapezoid joint.
  • the scaphoid bone is the first external bone of the first row (proximal row) of the carpus. It has a cuboid shape, with six faces, of which four are articular, and presenting a proximal pole and a distal pole. It articulates with the radius, lunate bone, large bone, trapezoid bone, and trapezius bone.
  • the scaphoid plays a fundamental role as it acts as a connecting link between the two rows.
  • scaphoid and post-traumatic or idiopathic avascular bone necrosis are closely related to its anatomy, since the scaphoid bone is covered in more than 80% of articular cartilage where the supply main blood comes from the dorsal radial artery (70-80%), through the ligamentous attachments, although the blood supply at the proximal pole level depends only on intraosseous flow, which explains the delayed consolidation rates, recalcitrant pseudoarthrosis or NOA. Faced with any of these injuries, it will be indicated to carry out a surgical gesture in order to start the osteogenesis process again, correct bone deformities and avoid carpal collapse secondary to non-union.
  • NOA idiopathic avascular bone necrosis
  • the primary surgical options include the use of vascularized and non-vascularized bone grafts, with or without supplemental fixation with needles and screws.
  • these techniques are not always successful, and in some cases we find episodes of pseudoarthrosis or advanced NOA where, secondarily, an instability of the midcarpal joint has been generated that leads to the development of osteoarthritis and carpal collapse, following the patterns called SNAC wrist ( “Scaphoid nonunion advange collapse ').
  • the progression of the SNAC wrists is slow, presenting arthritic changes from 5-10 years after the initial injury in the scaphoid.
  • the joint between it and the radius remains preserved for many years, acting as a second lunate, which on many occasions does not prevent a progressive degenerative process of its cartilage, fragmentation and trabecular collapse.
  • the mission of an orthopedic surgeon should be to try to relieve pain while maintaining the greatest range of motion and strength possible.
  • Scaphoid excision represents an alternative in the treatment of advanced carpal osteoarthritis.
  • Scaphoidectomy is a relatively simple technique for those patients with symptoms secondary to chronic nonunion of the scaphoid or bone necrosis of the proximal fragment, a fragment with a more precarious vascularization where this pathology generally takes root.
  • Scaphoid excision can be partial at the distal pole, at the proximal pole, or complete.
  • Isolated complete scaphoidectomy is a technique currently ruled out as it presents problems associated with progressive carpal collapse with pain, significant loss of strength and mobility. Therefore, if it is carried out, it requires complementary techniques that stabilize the rest of the bones so that they transmit the load through the lunate bone.
  • European patent No. EP3170477 and WO201886765 describe respective scaphoid prostheses manufactured in a compatible biomaterial, where this material can comprise at least one element from the group consisting of titanium or be a polymer, such as a polyetherketone or a ceramic material. , eg, a ceramic material containing zirconium.
  • this material can comprise at least one element from the group consisting of titanium or be a polymer, such as a polyetherketone or a ceramic material. , eg, a ceramic material containing zirconium.
  • these scaphoid prostheses have a central channel along their axis.
  • the tendon plasty is passed, which is fixed by drilling a channel (110) through the lunate where the tendon is passed again according to the Henry / Corella technique and the dorsal and palmar ligaments of the scapho-lunar are biomechanically reconstructed to ensure the physiological movement of the prosthesis.
  • They are also known from patent document No. US4198712 and US4936860 respective complete scaphoid prostheses.
  • Implant instability has been observed in many of the current models, regardless of the material used, with pain, implant flexion and carpal collapse with deformity in DISI.
  • the pyrolytic carbon material has been used in arthroplasties of the trapeziometacarpal, interphalangeal or lunate joint.
  • a prosthesis in this case partial, in the shape of an ellipsoid for the proximal pole of the scaphoid, made of pyrolytic carbon, is known from patent document No. US6090145.
  • This prosthesis is known as APSI “Adaptive Proximal Scaphoid Implant” (Bioprofile®, Grenoble, France), and is used for cases of avascular necrosis or proximal nonunion without arthritic signs in the proximal radioscaphoid joint.
  • This prosthesis is inserted between the lunate bone and the distal scaphoid remnant after an exeresis of the proximal pole, its stability being based on the three-dimensional adaptation of the implant to the movements of the wrist.
  • implant or prosthesis is used interchangeably, with the same meaning.
  • proximal is used as the part of the scaphoid closest to the radius, and the term “distal” as the part of the scaphoid furthest from the radius.
  • the object of the present invention is to provide a partial prosthesis for a proximal part of the scaphoid bone of a patient, which solves the aforementioned drawbacks and has the advantages that are described below.
  • the present invention provides a partial prosthesis of the scaphoid bone, adapted to replace, after an exeresis of a proximal part of the real scaphoid of a patient, said removed proximal part, while the remaining part of the real scaphoid corresponding to the side distal remains in place without retreating as bone remnant, characterized in that it comprises a body: with a shape and external dimensions that correspond substantially to the actual morphology of the part removed from the scaphoid corresponding to a portion of the proximal side of the scaphoid, which, on the distal side, comprises a blind hole that extends along the prosthesis, where this blind hole comprises at least one threaded portion so that a fixation element can pass through the scaphoid bone remnant in a retrograde direction to stabilize the prosthesis distally, and that, on the proximal side , comprises through channels for the passage of a proximal tendinous plast
  • the prosthesis is made of a material that comprises a biocompatible material.
  • the prosthesis of the invention is based on maintaining the intrinsic capacity of the wrist at the distal pole, which is not affected in most cases, and making an anatomical partial prosthesis that only requires stabilization at the proximal level.
  • the distal third of the scaphoid is maintained together with the trapezius, so the prosthesis of the invention respects the intrinsic ligaments of the wrist, which play an important role in carpal kinematics during the different movements, especially in the “throwing darts” movement.
  • this distal scaphoid remnant will be used for the distal anchoring of the prosthesis, so that in future wrist movement they act as a single block, imitating the previous movement of the scaphoid.
  • the prosthesis of the invention advantageously does not act as a simple spacer (as is the case of patent No. US6090145) that, due to its curved surfaces and the low coefficient of friction that pyrolytic carbon presents, allows the prosthesis to slide , which is undesirable since it leads to a risk of implant dislocation.
  • This type of prosthesis type "spacers" were placed where previously the damaged bone was and filled its space to avoid collapse. The problem is that these systems were not fixed to other carpal bones trying to reproduce the normal anatomy of the wrist where there are multiple intrinsic and extrinsic ligaments that allow it to act in a coordinated and synchronous manner.
  • this invention does not have any anchor at the level of the radius that passes through the radiocarpal joint, which is also undesirable.
  • the implant of the present invention is optimally held in position in the patient, thanks to:
  • this invention does not use the flexor carpi radialis, a tendon involved in carpal kinetics that allows flexion of the hand on the forearm and also acts in part of the pronation and abduction movements. Failing that, the Long Palmar Flexor (Palmaris Longus) is used, an inconstant, narrow and elongated muscle that does not contribute to the kinetics or kinematics of the carpus, so that it may even be absent in 20% of patients, thus specifying the use of another donor tendon that does not alter the normal biology or mechanics of the organism, such as the Plantar Delgado.
  • the knockout hole is arranged in a substantially central position within the body, and in the desired orientation.
  • the threaded portion of the blind hole is disposed at the proximal end of said blind hole.
  • the aforementioned threaded portion of the blind hole comprises, according to a preferred embodiment, a thread in the part of the proximal end where it will engage the coil of the compression screw, which has a different thread pitch and a different diameter between the proximal and distal portion to allow compression.
  • self-drilling is performed by passing the self-tapping and self-drilling screw mentioned above.
  • the surface of the prosthesis that contacts the scaphoid bone remnant comprises a rough material, i.e. not polished. This, advantageously, achieves a correct osseointegration with the bone remnant and avoids micromotion.
  • the present invention provides the above-described partial prosthesis that further incorporates the fixation element, to anchor the prosthesis to the distal scaphoid bone remnant.
  • the fixation element is a cannulated screw with a length between 18 and 26 mm. This cannulated screw is inserted through the bone remnant in a retrograde direction (ie distal to proximal), stabilizing the prosthesis. During the intervention, it is preferably guided by a Kirschner wire that allows the remnant to be connected to the prosthesis.
  • the effects of this connection to the bone remnant consist of a decrease in the “microgap” between both components (prosthesis and scaphoid bone remnant). This fact is verified, from a mechanical point of view, in a decrease in the implant-bone remnant micro-movements, supported by an increase in their contact surface, with the consequent improvement in stability.
  • the prosthesis comprises proximal channels that allow a proximal (biological) tendon plasty to pass with the long palmar flexor or, failing that, with the plantar thin one up to the lunate bone.
  • proximal plasty In the process of designing the proximal plasty, it is used, as in the 3LT technique by Marc Garc ⁇ a Elias, the reconstruction of the dorsal lunate ligament and in the same way the ulnar traction of the lunate and pyramidal is decreased by tightening the joint to the radiopyramidal ligament.
  • This proximal tendon plasty that passes through channels from the proximal pole of the scaphoid prosthesis to the lunate bone simulates the scapholunate ligament. With this, it is intended that the prosthesis simulates the scaphoid in carpal kinematics, avoiding its flexion and subluxation when applying loads.
  • these proximal through channels of the prosthesis body are two channels that intersect each other, forming a "T", so that there are three openings in the body. These channels are preferably straight. These channels are of such a diameter to allow a tendon plasty to pass.
  • the lunate bone must have previously been drilled through two openings (opening from dorsal to palmar and opening from the lunate side to converge with the other perforation), so the doctor opens two channels in the lunate bone connected to each other.
  • the partial denture is anchored distally with a retrograde fixation screw.
  • the shape and exterior dimensions of the prosthesis body correspond substantially to the actual morphology of a part of the distal side greater than the proximal pole itself.
  • the shape and exterior dimensions of the body of the prosthesis correspond substantially to the actual morphology of the 2/3 parts of the proximal side of the actual scaphoid removed from a patient, while the remaining distal 1/3 of the scaphoid remains in place without retreating.
  • a partial prosthesis of a proximal part can be made with a portion other than 2/3 parts as long as it is sufficient to allow proximal stabilization of the lunate with a plasty through the transosseous channels mentioned above and allows the step of the retrograde screw exerting distal stabilization.
  • the body of the prosthesis presents a narrowing at the waist level of the resulting scaphoid, simulating the part of the waist of the real scaphoid removed. It also has a base on the distal side, substantially flat, for attachment to the distal bone remnant.
  • the shape and external dimensions of the body of the prosthesis will depend on the anatomical shapes and sizes of the scaphoid of each patient.
  • the prosthesis is manufactured, preferably, in three different sizes, and a prosthesis for the left side and others for the right side. However, this prosthesis can be made to measure, according to the specific dimensions of each patient. It can be manufactured according to known manufacturing techniques, for example by 3D printing.
  • the optimal exterior dimensions of the prosthesis can vary according to the following parameters: length of the prosthesis body from the proximal end to the distal end added to the length of the bone remnant between 25 and 31 mm. thickness at the level of the scaphoid girdle of the prosthesis is between 8 and 1 1, 9mm.
  • the blind hole of the prosthesis extends along the prosthesis with a total length between 10 and 20mm. and it has a diameter between 3 to 4mm., and more preferably 3.5mm.
  • the proximal channels of the prosthesis have a diameter of between 2 and 4mm, and more preferably between 2.5 and 3.5mm.
  • the exit of the central hole and the proximal channels can be rounded or blunt, so as not to damage the plasty and prevent it from breaking or cutting.
  • the body of the prosthesis is made of an outer portion of biocompatible ceramic.
  • it can be formed of a metallic alloy with at least one outer portion of biocompatible ceramic.
  • Pyrolytic carbon is a totally biocompatible material, highly resistant to deterioration by friction, practically indestructible and chemically inert, without causing bone wear. Its coefficient of friction is very low, which allows the implant to slide without causing bone wear in order to achieve the least resistance. Furthermore, its Young's modulus, identical to that of bone, allows it to be perfectly tolerated.
  • the prosthesis of the present invention is used, preferably, in cases of recalcitrant pseudoarthrosis of the scaphoid, avascular necrosis thereof, Preiser's disease, acute fractures with great comminution or displacement where it is impossible to perform an anatomical reduction and primary osteosynthesis, or in cases of Incipient osteoarthritis of the wrist secondary to advanced collapse due to scaphoid nonunion, provided there is no compromise of SNAC III-IV type intercarpal degeneration.
  • prosthesis of the invention remains stabilized to the rest of the carpal bones, imitating the native scaphoid and, therefore, fully integrated with the carpal kinematics. In this way, there is an implant that replaces the non-viable part of the scaphoid while maintaining the distal third of it, which allows prosthetic anchorage and behaves as a unit. In addition, the prosthesis is also stabilized at the proximal level to recreate 100% carpal anatomy and kinematics.
  • Figures 1 to 5 represent different views of a possible embodiment of the prosthesis of the invention, where the shape and external dimensions can be seen, as well as the three openings of the two proximal channels for the passage of the plasty and the opening on the distal side. the central knockout hole.
  • Figure 6 schematically represents the carpal bones, where the scaphoid bone has not been removed.
  • Figure 7 schematically represents the carpal bones in a position other than that of Figure 6, where the most proximal part of the scaphoid bone has been removed and has been replaced by the partial prosthesis of the invention and with the plasty inserted.
  • FIGS 8 and 9 schematically represent respective detailed views of the prosthesis of the invention once positioned in a patient and with the plasty inserted.
  • Figure 10 schematically represents a possible embodiment of the cannulated fixation screw.
  • the kinematic behavior of the prosthesis (10) of the invention has been empirically tested by the owner on cadavers, with satisfactory results. The tests carried out were:
  • the cadaver forearm piece is prepared (with 4 to 6 specimen pieces). Almost all soft tissues are removed both proximally and distally, leaving only four axes of traction that correspond to the flexor carpi radialis, flexor carpi lunaris, extensor carp ⁇ s lunaris and extensor carp ⁇ s radialis longus and brevis that work together.
  • the forearm is attached to a support by means of screws anchored in the ulna and radius and connected to a photogrammetry system with several dynamometers in the 4 main tendons that allows to apply flexion-extension forces and radial and ulnar deviation and analyze them.
  • the complete real scaphoid bone (1) is located in the carpus being in contact with the trapezoid (6), the trapezoid (5), the large one (4), the lunate (3), and the radius (7).
  • the scaphoid bone (1) has a length "A” and a thickness at the level of the waist "B", the parameters of which will depend on each patient.
  • Figures 7 to 9 represent the situation of the carpus in which the prosthesis (10) of the invention has already been placed in place, keeping the bone remnant on the distal side of the scaphoid bone (2).
  • the prosthesis (10) is firmly attached to the bone remnant (2) by means of a screw (in Figures 7 to 9 only the hole (12) is shown while in Figure 10 the screw (18 ), which is arranged within the central blind hole (12).
  • the prosthesis is anatomically stabilized with the lunate bone (3) by means of a tendon plasty (23) with the Flexor Palmar Largo muscle or with the Plantar Delgado
  • This tendon plasty (23) is arranged by forming two loops that pass through the channels (16 and 17) following the operations described in the part of the Description, and being fixed by means of a suture point (22), see Figures 8 and 9.
  • the final end and the proximal end of the plasty (23), once the two loops have been passed, are sewn on the same plasty (23) already passed.
  • this particular embodiment of the prosthesis (10) of the invention presents a body with a shape and external dimensions that substantially correspond to the real morphology of 2/3 parts of the proximal side that have previously been removed from the scaphoid of a patient. It has a surface (1 1) on the distal side that is substantially flat, where an opening (12a) is provided, which extends to form the central blind hole (12).
  • the body of the prosthesis is solid and at the proximal level it has three openings (13, 14, and 15) that form two channels (16, 17) that intercept each other for the passage of the plasty (23).
  • the first channel (16) extends from the first opening (13) to the second channel (17), and this second channel (17) extends from the second opening (14) until reaching the third opening (15). It can be seen in Figure 5 how these two channels intersect forming a "T" shape.
  • FIG 10 shows a possible configuration of the screw (18) that is screwed inside the central blind hole (12) of the prosthesis and the continuation of the central blind hole (12) of the bone remnant (2).
  • Said screw (18) has a slightly conical body, and is characterized in that its proximal and distal threads have different size and different thread pitch. Thus, it has a lower portion (screw head area) (21) equipped with a larger and larger thread, an intermediate portion (20) without thread, and an upper portion (screw tip) (19) provided with a smaller pitch and smaller thread, wherein the upper portion (called the first thread pitch) (19) is adapted to be threaded into the internal thread (13a) of the hole (12) of the prosthesis (10).

Abstract

The invention relates to a partial prosthesis for the scaphoid bone, which is adapted to replace a proximal portion of the scaphoid bone following its removal, thereby protecting at least the distal pole of the entire scaphoid bone and maintaining the integrity of the scaphotrapeziotrapezoid joint. It has the advantage of not having radial anchoring that passes through the radiocarpal joint. Instead, the prosthesis is kept in position by means of: (a) distal anchoring to the remaining scaphoid bone using a blind hole, for example, by means of a threaded Morse taper; and (b) proximal stabilisation by means of proximal channels that enable a tendon graft, formed by the palmaris longus flexor muscle or the plantaris muscle, to pass to the semilunar bone.

Description

PRÓTESIS PARCIAL PARA EL HUESO ESCAFOIDES PARTIAL PROSTHESIS FOR THE SCAFOID BONE
La presente invención se refiere a una prótesis parcial del hueso escafoides, adaptada para sustituir, tras una exéresis de una porción proximal del escafoides real, dicha porción proximal retirada, manteniendo de ese modo indemne como mínimo el polo distal del hueso escafoides integro y además con integridad de la articulación escafo-trapecio-trapezoidea. The present invention relates to a partial scaphoid bone prosthesis, adapted to replace, after exeresis of a proximal portion of the actual scaphoid, said removed proximal portion, thereby keeping at least the distal pole of the entire scaphoid bone undamaged and furthermore with integrity of the scapho-trapezius-trapezoid joint.
Antecedentes de la invención Background of the invention
La muñeca, y especialmente los huesos carpianos, forman un conjunto articular sometido a importantes fuerzas de cizallamiento, torsión y compresión. El hueso escafoides es el primer hueso externo de la primera fila (fila proximal) del carpo. Presenta una forma cuboidea, con seis caras, de las cuales cuatro son articulares, y presentando un polo proximal y un polo distal. Se articula con el radio, hueso semilunar, hueso grande, hueso trapezoide y hueso trapecio. Dentro del carpo, el escafoides ocupa un papel fundamental pues actúa como nexo de unión entre las dos hileras. Cualquier alteración en el mismo conlleva una modificación de la biomecánica de la muñeca, causando una transmisión anormal de cargas entre el radio y el escafoides que llevan a una clínica de dolor con pérdida de movilidad y en un futuro a la inestabilidad articular que derivará en una artrosis carpiana. The wrist, and especially the carpal bones, form a joint joint subjected to significant forces of shear, torsion and compression. The scaphoid bone is the first external bone of the first row (proximal row) of the carpus. It has a cuboid shape, with six faces, of which four are articular, and presenting a proximal pole and a distal pole. It articulates with the radius, lunate bone, large bone, trapezoid bone, and trapezius bone. Within the carpus, the scaphoid plays a fundamental role as it acts as a connecting link between the two rows. Any alteration in the same entails a modification of the biomechanics of the wrist, causing an abnormal transmission of loads between the radius and the scaphoid that leads to pain symptoms with loss of mobility and in the future to joint instability that will lead to a carpal osteoarthritis.
Por otra parte, tras un impacto en mano o muñeca las fracturas del hueso escafoides son las más comunes, representando el 80% de las fracturas del carpo. La importancia de su correcto diagnóstico y tratamiento en fase aguda es fundamental para el pronóstico y evolución, pues las lesiones de este hueso no tratadas o incorrectamente manejadas tendrán complicaciones a largo plazo como la ausencia de consolidación o pseudoartrosis, la necrosis avascular hasta en un 50% de los casos o la inestabilidad crónica que conducirán progresivamente al desarrollo de una artrosis carpiana. On the other hand, after an impact on the hand or wrist, scaphoid bone fractures are the most common, representing 80% of carpal fractures. The importance of its correct diagnosis and treatment in the acute phase is fundamental for the prognosis and evolution, since the lesions of this bone not treated or incorrectly managed will have long-term complications such as the absence of consolidation or pseudoarthrosis, avascular necrosis up to 50 % of cases or chronic instability that will progressively lead to the development of carpal osteoarthritis.
La“no-unión” crónica del escafoides y la necrosis ósea avascular (NOA) postraumática o idiopática (Enfermedad de Preiser) guardan una estrecha relación con su anatomía, pues el hueso escafoides está cubierto en más del 80% de cartílago articular donde el suministro sanguíneo principal proviene de la arteria radial dorsal (70-80%), a través de las inserciones ligamentosas, si bien el aporte sanguíneo a nivel del polo proximal depende únicamente del flujo intraóseo, lo que explica las tasas de retardo de consolidación, pseudoartrosis recalcitrante o NOA. Ante cualquiera de estas lesiones citadas estará indicado llevar a cabo un gesto quirúrgico con el fin de poner nuevamente en marcha el proceso de osteogénesis, corregir las deformidades óseas y evitar el colapso carpal secundario a la no-unión. Chronic “non-union” of the scaphoid and post-traumatic or idiopathic avascular bone necrosis (NOA) (Preiser's disease) are closely related to its anatomy, since the scaphoid bone is covered in more than 80% of articular cartilage where the supply main blood comes from the dorsal radial artery (70-80%), through the ligamentous attachments, although the blood supply at the proximal pole level depends only on intraosseous flow, which explains the delayed consolidation rates, recalcitrant pseudoarthrosis or NOA. Faced with any of these injuries, it will be indicated to carry out a surgical gesture in order to start the osteogenesis process again, correct bone deformities and avoid carpal collapse secondary to non-union.
Dentro de las opciones quirúrgicas primarias se plantea el uso de injertos de hueso vascularizados y no vascularizados, con o sin fijación suplementaria con agujas y tornillos. Desafortunadamente, estas técnicas no siempre son exitosas, y en algunos casos nos encontramos con episodios de pseudoartrosis o NOA avanzados donde secundariamente se ha generado una inestabilidad de la articulación mediocarpiana que conduce al desarrollo de artrosis y colapso carpiano, siguiendo los patrones denominados muñeca SNAC (“ scaphoid nonunion advange collapse’). The primary surgical options include the use of vascularized and non-vascularized bone grafts, with or without supplemental fixation with needles and screws. Unfortunately, these techniques are not always successful, and in some cases we find episodes of pseudoarthrosis or advanced NOA where, secondarily, an instability of the midcarpal joint has been generated that leads to the development of osteoarthritis and carpal collapse, following the patterns called SNAC wrist ( “Scaphoid nonunion advange collapse ').
La progresión de las muñecas SNAC es lenta, presentando cambios artríticos a partir de los 5-10 años de la lesión inicial en el escafoides. En la muñeca SNAC con presencia de un fragmento proximal escafoideo la articulación entre este y el radio se mantiene conservada durante muchos años, actuando como un segundo semilunar, lo que no evita en bastantes ocasiones, un proceso degenerativo progresivo de su cartílago, la fragmentación y el colapso trabecular. El problema del colapso carpal avanzado es que plantea dificultades adicionales de tratamiento, en muchos casos no bien resueltas, pues en la mayoría de casos se optan por técnicas quirúrgicas de salvamento (carpectomía proximal, escisión del escafoides o artrodesis mediocarpianas como la cuatro esquinas o de la articulación luno-grande o artrodesis totales), donde se consigue controlar el dolor pero sacrificando un gran rango articular con la consiguiente limitación funcional en sus actividades de la vida diaria. Además todas estas cirugías, cada vez más agresivas, conllevan un alto riesgo de complicaciones como infección, pseudoartrosis, fallo del sistema de soporte, prominencia del sistema con irritación de las partes blandas o rigidez asociada a un tiempo prolongado de inmovilización. De hecho, en la artrodesis cuatro esquinas o en la carpectomía se elimina la articulación mediocarpiana y la revisión de estas intervenciones obligan a una artrodesis total de la muñeca o una artroplastia. The progression of the SNAC wrists is slow, presenting arthritic changes from 5-10 years after the initial injury in the scaphoid. In the SNAC wrist with the presence of a proximal scaphoid fragment, the joint between it and the radius remains preserved for many years, acting as a second lunate, which on many occasions does not prevent a progressive degenerative process of its cartilage, fragmentation and trabecular collapse. The problem of advanced carpal collapse is that it poses additional treatment difficulties, in many cases not well resolved, since in most cases salvage surgical techniques are chosen (proximal carpectomy, scaphoid excision or midcarpal arthrodesis such as the four corners or of the luno-large joint or total arthrodesis), where pain is controlled but sacrificing a great joint range with the consequent functional limitation in their activities of daily living. In addition, all these increasingly aggressive surgeries carry a high risk of complications such as infection, pseudoarthrosis, failure of the support system, prominence of the system with irritation of the soft tissues or rigidity associated with a long time of immobilization. In fact, in four-corner arthrodesis or carpectomy, the midcarpal joint is removed, and revision of these interventions requires a total wrist arthrodesis or arthroplasty.
La misión de un cirujano ortopeda debería ser intentar aliviar el dolor pero manteniendo el mayor rango de movilidad y fuerza posible. The mission of an orthopedic surgeon should be to try to relieve pain while maintaining the greatest range of motion and strength possible.
En la mayoría de articulaciones del cuerpo humano está establecido el uso de la artroplastia en casos de artrosis o NOA con el fin de recuperar la situación articular previa, controlando el dolor e intentando conservar el mayor rango articular. Sin embargo, a nivel de la articulación radio-escafoidea, la cirugía reconstructiva deja paso a la cirugía de salvamento, donde efectivamente se controla el dolor del paciente, pero a un precio muy alto. En estos casos, se debería disponer de una alternativa donde se pudiera ofrecer al paciente muñecas más móviles sin dolor, siendo la sustitución protésica una alternativa factible. In most joints of the human body, the use of arthroplasty is established in cases of osteoarthritis or NOA in order to recover the previous joint situation, controlling pain and trying to preserve the greater joint range. However, at the level of the joint radio-scaphoid, reconstructive surgery gives way to salvage surgery, where the patient's pain is effectively controlled, but at a very high price. In these cases, an alternative should be available where more mobile wrists without pain could be offered to the patient, with prosthetic replacement being a feasible alternative.
La escisión del escafoides representa una alternativa en el tratamiento de la artrosis carpiana avanzada. La escafoidectomía es una técnica relativamente sencilla para aquellos pacientes con síntomas secundarios a la no unión crónica del escafoides o a la necrosis ósea del fragmento proximal, fragmento con una vascularización más precaria donde generalmente asienta esta patología. Scaphoid excision represents an alternative in the treatment of advanced carpal osteoarthritis. Scaphoidectomy is a relatively simple technique for those patients with symptoms secondary to chronic nonunion of the scaphoid or bone necrosis of the proximal fragment, a fragment with a more precarious vascularization where this pathology generally takes root.
La exéresis escafoidea puede ser parcial a nivel de su polo distal, a nivel del polo proximal o completa. La escafoidectomía completa aislada es una técnica actualmente descartada pues presenta problemas asociados al progresivo colapso carpal con dolor, pérdida importante de fuerza y de movilidad. Por lo que, en caso de realizarse, precisa de técnicas complementarias que estabilicen el resto de huesos para que transmitan la carga a través del hueso semilunar. Scaphoid excision can be partial at the distal pole, at the proximal pole, or complete. Isolated complete scaphoidectomy is a technique currently ruled out as it presents problems associated with progressive carpal collapse with pain, significant loss of strength and mobility. Therefore, if it is carried out, it requires complementary techniques that stabilize the rest of the bones so that they transmit the load through the lunate bone.
La idea de estabilizar el carpo tras la escisión del escafoides con una artroplastia ha sido intentada en repetidas ocasiones. Sus defensores argumentan que es una técnica sencilla y menos agresiva que las técnicas de salvamento donde se recupera la anatomía y la biomecánica del carpo sin sacrificar otras articulaciones. Además, en caso de fallo siempre existe la posibilidad de recurrir a una artrodesis cuatro esquinas o la carpectomía proximal. The idea of stabilizing the carpus after excision of the scaphoid with arthroplasty has been tried repeatedly. Its defenders argue that it is a simple and less aggressive technique than salvage techniques where the anatomy and biomechanics of the carpus are recovered without sacrificing other joints. Furthermore, in case of failure there is always the possibility of resorting to a four-corner arthrodesis or proximal carpectomy.
En la actualidad se conocen algunos modelos de prótesis diseñadas para sustituir todo el hueso escafoides. Por ejemplo, la patente europea No. EP3170477 y WO201886765 describen respectivas prótesis de escafoides fabricadas en un biomaterial compatible, donde este material puede comprender al menos un elemento del grupo que consiste en titanio o ser un polímero, tal como una polietercetona o un material cerámico, p.ej., un material cerámico que contiene zirconio. Sin embargo, para la estabilización de estas prótesis de escafoides las mismas cuentan con un canal central a lo largo de su eje. En éste se pasa la plastia tendinosa que se fija mediante la perforación de un canal (110) a través del semilunar donde nuevamente se pasa el tendón según la técnica de Henry/Corella y se reconstruye biomecánicamente los ligamentos dorsal y palmar de escafo-lunar para asegurar el movimiento fisiológico de la prótesis. También se conocen por el documento de patente No. US4198712 y US4936860 respectivas prótesis completa de escafoides. En el primer caso (US4198712) se describe una prótesis réplica anatómica completa del escafoides, con un vástago (78) que se introduce en el trapecio (es decir en el hueso de la hilera distal del carpo) y se fija al semilunar con una sutura transósea con Dexon de 2-0 para proporcionar estabilidad al implante, o bien en casos que la anatomía del paciente no permita el uso de vástagos este puede ser acortado o incluso eliminado y se fija mediante una sutura transósea al trapecio. Está fabricada de un material elástico. En el segundo caso (US4936860) se describe también una prótesis réplica anatómica completa del escafoides, pero en este caso metálica, y presenta un eje (104) que se extiende por el interior del cuerpo del implante. Se posiciona en la muñeca con el eje que se introduce en el trapecio para proporcionar estabilidad al implante con un procedimiento similar al descrito en la patente No. US4198712. Los primeros resultados publicados de la primera prótesis (US4198712) fueron muy esperanzadores, sin embargo, a largo plazo se observó que el colapso carpal evolucionaba, posiblemente asociado al desarrollo en la mayoría los pacientes de una sinovitis por partículas de silicona (88% a los 8 años) 12, 13. Este hecho llevó a la retirada del implante en algunas series en el 90% de los pacientes por dolor con necesidad de realizar intervenciones de artrodesis parcial en aproximadamente un 25-30% de los casos. Currently, some models of prostheses designed to replace the entire scaphoid bone are known. For example, European patent No. EP3170477 and WO201886765 describe respective scaphoid prostheses manufactured in a compatible biomaterial, where this material can comprise at least one element from the group consisting of titanium or be a polymer, such as a polyetherketone or a ceramic material. , eg, a ceramic material containing zirconium. However, for the stabilization of these scaphoid prostheses they have a central channel along their axis. In this, the tendon plasty is passed, which is fixed by drilling a channel (110) through the lunate where the tendon is passed again according to the Henry / Corella technique and the dorsal and palmar ligaments of the scapho-lunar are biomechanically reconstructed to ensure the physiological movement of the prosthesis. They are also known from patent document No. US4198712 and US4936860 respective complete scaphoid prostheses. In the first case (US4198712) a complete anatomical replica prosthesis of the scaphoid is described, with a stem (78) that is inserted in the trapezius (that is, in the bone of the distal row of the carpus) and is fixed to the lunate with a suture Transosseous with 2-0 Dexon to provide stability to the implant, or in cases where the anatomy of the patient does not allow the use of stems, it can be shortened or even eliminated and fixed by means of a transosseous suture to the trapezius. It is made of an elastic material. In the second case (US4936860) a complete anatomical replica prosthesis of the scaphoid is also described, but in this case metallic, and it presents a shaft (104) that extends inside the implant body. It is positioned on the wrist with the shaft that is inserted into the trapezius to provide stability to the implant with a procedure similar to that described in patent No. US4198712. The first published results of the first prosthesis (US4198712) were very encouraging, however, in the long term it was observed that the carpal collapse progressed, possibly associated with the development in most patients of a synovitis due to silicone particles (88% of the patients). 8 years) 12, 13. This fact led to implant removal in some series in 90% of patients due to pain requiring partial arthrodesis interventions in approximately 25-30% of cases.
Los fallos en los intentos de sustituir el escafoides se han atribuido al material, sinovitis secundaria al silastic y la inestabilidad del implante. La inestabilidad del implante se ha observado en muchos de los modelos actuales, independientemente del material utilizado, apareciendo dolor, flexión del implante y colapso carpiano con deformidad en DISI. Failures in attempts to replace the scaphoid have been attributed to the material, synovitis secondary to silastic, and implant instability. Implant instability has been observed in many of the current models, regardless of the material used, with pain, implant flexion and carpal collapse with deformity in DISI.
El material carbono pirolítico, ha sido empleado en artroplastias de la articulación trapecio- metacarpiana, interfalángicas o del semilunar. The pyrolytic carbon material has been used in arthroplasties of the trapeziometacarpal, interphalangeal or lunate joint.
Se conoce, a través del documento de patente No. US6090145, una prótesis, en este caso parcial, en forma de elipsoide para el polo proximal del escafoides, fabricada en carbón pirolítico. Esta prótesis se conoce como APSI “Adaptive Proximal Scaphoid Implant” (Bioprofile®, Grenoble, Francia) , y se utiliza para casos de necrosis avascular o no unión proximal sin signos artrósicos en la articulación radioescafoidea proximal. Dicha prótesis se introduce entre el hueso semilunar y el remanente del escafoides distal tras una exéresis del polo proximal, radicando su estabilidad en la adaptación tridimensional del implante a los movimientos de la muñeca. Por lo tanto, no proporciona ningún tipo de elemento de fijación al resto de huesos ni ligamentos del carpo y únicamente actúa como un mero espaciador, es decir está en contacto móvil con al menos una superficie de hueso y el implante permanece libre. Se ha constatado que, a corto plazo, esta prótesis permite una recuperación de la fuerza de prensión similar a la muñeca contralateral, una movilidad simétrica al lado contralateral. Sin embargo, es difícil entender que un implante que prescinda de la sujeción que proporcionan los ligamentos intrínsecos del carpo pueda mantenerse en su sitio simplemente con la ayuda de la cápsula articular o de su morfología tridimensional, por lo que con este implante persiste el problema de la inestabilidad. Existen actualmente estudios a largo plazo con una media de 8,7 años de seguimiento que así lo corroboran, presentando un 21 % de luxaciones del implante o deformidad en DISI. Por lo tanto, persiste el problema de la estabilización una prótesis parcial de escafoides para intentar mantener al implante en posición para minimizar el riesgo de una luxación del implante y que este funcione según la cinemática carpal. A prosthesis, in this case partial, in the shape of an ellipsoid for the proximal pole of the scaphoid, made of pyrolytic carbon, is known from patent document No. US6090145. This prosthesis is known as APSI “Adaptive Proximal Scaphoid Implant” (Bioprofile®, Grenoble, France), and is used for cases of avascular necrosis or proximal nonunion without arthritic signs in the proximal radioscaphoid joint. This prosthesis is inserted between the lunate bone and the distal scaphoid remnant after an exeresis of the proximal pole, its stability being based on the three-dimensional adaptation of the implant to the movements of the wrist. Therefore, it does not provide any type of fixing element to the rest of the bones or ligaments of the carpus and only acts as a mere spacer, that is, it is in mobile contact with at least one bone surface and the implant remains free. It has been found that, in the short term, this prosthesis allows a recovery of grip strength similar to that of the contralateral wrist, a symmetrical mobility to the contralateral side. However, it is difficult to understand that an implant that dispenses with the support provided by the intrinsic carpal ligaments can be kept in place simply with the help of the joint capsule or its three-dimensional morphology, so with this implant the problem of Instability. There are currently long-term studies with a mean follow-up of 8.7 years that corroborate this, presenting 21% of implant dislocations or deformity in DISI. Therefore, the problem of stabilizing a partial scaphoid prosthesis persists in an attempt to keep the implant in position to minimize the risk of implant dislocation and for it to function according to carpal kinematics.
A la vista de lo expuesto anteriormente, existe una necesidad evidente de una prótesis parcial de una parte proximal del hueso escafoides, que permita estabilizar la prótesis para mantenerla sin desplazarse y que éste funcione según la cinemática carpal, reduciendo así e incluso eliminando completamente el riesgo de una luxación de la prótesis. In view of the above, there is an evident need for a partial prosthesis of a proximal part of the scaphoid bone, which allows stabilizing the prosthesis to keep it without moving and that it works according to carpal kinematics, thus reducing and even completely eliminating the risk of a dislocation of the prosthesis.
Descripción de la invención Description of the invention
En la descripción de esta invención se utiliza indistintamente de término implante o prótesis, con el mismo significado. In the description of this invention, the term implant or prosthesis is used interchangeably, with the same meaning.
En la descripción de esta invención se utiliza el término“proximal” como la parte del escafoides más cercana al radio, y el término“distal” como la parte del escafoides más alejada del radio. In the description of this invention the term "proximal" is used as the part of the scaphoid closest to the radius, and the term "distal" as the part of the scaphoid furthest from the radius.
El objeto de la presente invención es el de proporcionar una prótesis parcial para una parte proximal del hueso escafoides de un paciente, que resuelve los inconvenientes mencionados y presenta las ventajas que se describen a continuación. The object of the present invention is to provide a partial prosthesis for a proximal part of the scaphoid bone of a patient, which solves the aforementioned drawbacks and has the advantages that are described below.
Según un primer aspecto, la presente invención proporciona una prótesis parcial del hueso escafoides, adaptada para sustituir, tras una exéresis de una parte proximal del escafoides real de un paciente, dicha parte proximal retirada, mientras que la parte restante del escafoides real correspondiente al lado distal permanece en su sitio sin retirarse como remanente óseo, caracterizada porque comprende un cuerpo: con una forma y dimensiones exteriores que corresponden sustancialmente a la morfología real de la parte retirada del escafoides correspondiente a una porción del lado proximal del escafoides, que, en el lado distal, comprende un orificio ciego que se extiende a lo largo de la prótesis, donde este orificio ciego comprende como mínimo una porción roscada para que a través del remanente óseo de escafoides en dirección retrógrada puede pasar un elemento de fijación para estabilizar distalmente la prótesis, y que, en el lado proximal, comprende unos canales pasantes para el paso de una plastia tendinosa proximal con el músculo Flexor Palmar Largo o con el Plantar Delgado hasta el hueso semilunar, de modo que se estabiliza la prótesis a nivel proximal de manera anatómica con el hueso semilunar. According to a first aspect, the present invention provides a partial prosthesis of the scaphoid bone, adapted to replace, after an exeresis of a proximal part of the real scaphoid of a patient, said removed proximal part, while the remaining part of the real scaphoid corresponding to the side distal remains in place without retreating as bone remnant, characterized in that it comprises a body: with a shape and external dimensions that correspond substantially to the actual morphology of the part removed from the scaphoid corresponding to a portion of the proximal side of the scaphoid, which, on the distal side, comprises a blind hole that extends along the prosthesis, where this blind hole comprises at least one threaded portion so that a fixation element can pass through the scaphoid bone remnant in a retrograde direction to stabilize the prosthesis distally, and that, on the proximal side , comprises through channels for the passage of a proximal tendinous plasty with the Flexor Palmar Largo muscle or with the Plantar Delgado muscle up to the lunate bone, so that the prosthesis is anatomically stabilized at the proximal level with the lunate bone.
Además, la prótesis está fabricada de un material que comprende un material biocompatible. Furthermore, the prosthesis is made of a material that comprises a biocompatible material.
La prótesis de la invención se basa en mantener la capacidad intrínseca de la muñeca en el polo distal, no afecto en la mayoría de las ocasiones, y realizar una prótesis parcial anatómica que únicamente precisa de una estabilización a nivel proximal. Es decir que, en lugar de sustituir completamente el escafoides, se mantiene el tercio distal del escafoides junto con el trapecio, por lo que la prótesis de la invención respeta los ligamentos intrínsecos de la muñeca los cuales juegan un papel importante en la cinemática carpal durante los diferentes movimientos, especialmente en el movimiento“de lanzar dardos”. Además, este remanente de escafoides distal será utilizado para el anclaje distal de la prótesis, de manera que en futuro movimiento de la muñeca actúen como un bloque único imitando al movimiento previo del escafoides. The prosthesis of the invention is based on maintaining the intrinsic capacity of the wrist at the distal pole, which is not affected in most cases, and making an anatomical partial prosthesis that only requires stabilization at the proximal level. In other words, instead of completely replacing the scaphoid, the distal third of the scaphoid is maintained together with the trapezius, so the prosthesis of the invention respects the intrinsic ligaments of the wrist, which play an important role in carpal kinematics during the different movements, especially in the “throwing darts” movement. Furthermore, this distal scaphoid remnant will be used for the distal anchoring of the prosthesis, so that in future wrist movement they act as a single block, imitating the previous movement of the scaphoid.
Es decir que la prótesis de la invención ventajosamente no actúa como un simple espaciador (como es el caso de la patente No. US6090145) que debido a sus superficies curvadas y al bajo coeficiente de fricción que presenta el carbón pirolítico permite que la prótesis se deslice, lo que es indeseable puesto que deriva en un riesgo de una luxación del implante. Este tipo de prótesis tipo“espaciadores” eran colocadas donde previamente estaba el hueso dañado y rellenaban su espacio para evitar el colapso. El problema es que estos sistemas no estaban fijados a otros huesos del carpo intentando reproducir la anatomía normal de la muñeca donde existen múltiples ligamentos intrínsecos y extrínsecos que le permiten actuar de manera coordinada y sincrónica. In other words, the prosthesis of the invention advantageously does not act as a simple spacer (as is the case of patent No. US6090145) that, due to its curved surfaces and the low coefficient of friction that pyrolytic carbon presents, allows the prosthesis to slide , which is undesirable since it leads to a risk of implant dislocation. This type of prosthesis type "spacers" were placed where previously the damaged bone was and filled its space to avoid collapse. The problem is that these systems were not fixed to other carpal bones trying to reproduce the normal anatomy of the wrist where there are multiple intrinsic and extrinsic ligaments that allow it to act in a coordinated and synchronous manner.
Además, otra ventaja es que esta invención no cuenta con ningún anclaje a nivel del radio que atraviese la articulación radiocarpiana, lo que es también indeseable. Por el contrario, el implante de la presente invención se mantiene óptimamente en su posición en el paciente, gracias a: Furthermore, another advantage is that this invention does not have any anchor at the level of the radius that passes through the radiocarpal joint, which is also undesirable. On the contrary, the implant of the present invention is optimally held in position in the patient, thanks to:
- (a) su anclaje a nivel distal al remanente óseo de escafoides merced a la provisión de un único orificio ciego a nivel distal, por ejemplo, mediante sistema tipo cono morse con rosca, y - (a) its anchorage distally to the scaphoid bone remnant thanks to the provision of a single blind hole at the distal level, for example, by means of a threaded morse cone system, and
- (b) a su estabilización a nivel proximal de manera totalmente anatómica con el hueso semilunar gracias a la provisión de unos canales proximales para el paso de una plastia tendinosa formada por el músculo Flexor Palmar Largo o con el Plantar Delgado hasta el hueso semilunar. - (b) to its stabilization at the proximal level in a totally anatomical way with the lunate bone thanks to the provision of proximal channels for the passage of a tendinous plasty formed by the Flexor Palmar Largo muscle or with the Plantar Delgado to the lunate bone.
Otra ventaja es que, para la estabilización protésica, esta invención no usa el flexor carpís radialis, un tendón implicado en la cinética carpal que permite la flexión de la mano sobre el antebrazo y también actúa en parte de los movimientos de pronación y abducción. En su defecto, se usa el Flexor Palmar Largo (Palmaris Longus), un músculo inconstante, estrecho y alargado que no contribuye a la cinética ni cinemática del carpo, de forma que puede incluso estar ausente en un 20% de los pacientes, precisando entonces la utilización de otro tendón donante que no altera la normal biología o mecánica del organismo como es el Plantar Delgado. Another advantage is that, for prosthetic stabilization, this invention does not use the flexor carpi radialis, a tendon involved in carpal kinetics that allows flexion of the hand on the forearm and also acts in part of the pronation and abduction movements. Failing that, the Long Palmar Flexor (Palmaris Longus) is used, an inconstant, narrow and elongated muscle that does not contribute to the kinetics or kinematics of the carpus, so that it may even be absent in 20% of patients, thus specifying the use of another donor tendon that does not alter the normal biology or mechanics of the organism, such as the Plantar Delgado.
De modo preferente, el orificio ciego se dispone en una posición sustancialmente central dentro del cuerpo, y con la orientación deseada. Preferably, the knockout hole is arranged in a substantially central position within the body, and in the desired orientation.
De modo preferente, la porción roscada del orificio ciego está dispuesta en el extremo proximal del indicado orificio ciego. La citada porción roscada del orificio ciego comprende, según una realización preferida, una rosca en la parte del extremo proximal donde acoplará la espira del tornillo de compresión que cuenta con diferente paso de rosca y diferente diámetro entre la porción proximal y distal para permitir ejercer compresión en el momento de posicionar el escafoides. En el remanente de hueso escafoideo real se realiza el autoterrajado al pasar el tornillo autorroscante y autoperforante citado anteriormente. Opcionalmente, la superficie de la prótesis que contacta con el remanente de hueso escafoideo comprende un material rugoso, es decir no pulido. Ello, ventajosamente, logra una correcta osteointegración con el remanente de hueso y evita los micromovimientos. Preferably, the threaded portion of the blind hole is disposed at the proximal end of said blind hole. The aforementioned threaded portion of the blind hole comprises, according to a preferred embodiment, a thread in the part of the proximal end where it will engage the coil of the compression screw, which has a different thread pitch and a different diameter between the proximal and distal portion to allow compression. at the time of positioning the scaphoid. In the real scaphoid bone remnant, self-drilling is performed by passing the self-tapping and self-drilling screw mentioned above. Optionally, the surface of the prosthesis that contacts the scaphoid bone remnant comprises a rough material, i.e. not polished. This, advantageously, achieves a correct osseointegration with the bone remnant and avoids micromotion.
Según un segundo aspecto, la presente invención proporciona la prótesis parcial anteriormente descrita que incorpora, además, el elemento de fijación, para anclar la prótesis al remanente óseo distal de escafoides. Preferentemente, el elemento de fijación es un tornillo canulado con una longitud comprendida entre 18 y 26 mm. Este tornillo canulado se introduce a través del remanente óseo en dirección retrógrada (es decir en sentido de distal a proximal), estabilizando la prótesis. Durante la intervención, se guía preferentemente por una aguja Kirschner que permite conectar el remante con la prótesis. Los efectos de dicha conexión al remanente óseo consisten en una disminución del “microgap” entre ambos componentes (prótesis y remanente óseo de escafoides). Este hecho se verifica, desde un punto de vista mecánico, en un descenso de los micromovimientos implante-remanente óseo, apoyados en un aumento de la superficie de contacto de los mismos, con la consiguiente mejora en la estabilidad. According to a second aspect, the present invention provides the above-described partial prosthesis that further incorporates the fixation element, to anchor the prosthesis to the distal scaphoid bone remnant. Preferably, the fixation element is a cannulated screw with a length between 18 and 26 mm. This cannulated screw is inserted through the bone remnant in a retrograde direction (ie distal to proximal), stabilizing the prosthesis. During the intervention, it is preferably guided by a Kirschner wire that allows the remnant to be connected to the prosthesis. The effects of this connection to the bone remnant consist of a decrease in the “microgap” between both components (prosthesis and scaphoid bone remnant). This fact is verified, from a mechanical point of view, in a decrease in the implant-bone remnant micro-movements, supported by an increase in their contact surface, with the consequent improvement in stability.
Conforme se ha comentado inicialmente, la prótesis comprende unos canales proximales que permiten pasar una plastia tendinosa (biológica) proximal con el flexor palmar largo o en su defecto con el delgado plantar hasta el hueso semilunar. En el proceso de diseño de la plastia proximal, se utiliza, al igual que en la técnica 3LT de Marc García Elias, la reconstrucción del ligamento semilunar dorsal y de igual forma se disminuye la tracción cubital del semilunar y piramidal mediante el tensado de la unión al ligamento radiopiramidal. As initially discussed, the prosthesis comprises proximal channels that allow a proximal (biological) tendon plasty to pass with the long palmar flexor or, failing that, with the plantar thin one up to the lunate bone. In the process of designing the proximal plasty, it is used, as in the 3LT technique by Marc García Elias, the reconstruction of the dorsal lunate ligament and in the same way the ulnar traction of the lunate and pyramidal is decreased by tightening the joint to the radiopyramidal ligament.
Esta plastia tendinosa proximal que pasa a través de unos canales desde el polo proximal de la prótesis escafoidea al hueso semilunar simula el ligamento escafosemilunar. Con ello se pretende que la prótesis simule al escafoides en la cinemática carpal, evitando su flexión y subluxación al aplicar cargas. This proximal tendon plasty that passes through channels from the proximal pole of the scaphoid prosthesis to the lunate bone simulates the scapholunate ligament. With this, it is intended that the prosthesis simulates the scaphoid in carpal kinematics, avoiding its flexion and subluxation when applying loads.
Según una realización preferida de la invención, estos canales pasantes proximales del cuerpo de la prótesis son dos canales que se entrecruzan entre sí, formando una“T”, de manera que hay tres aberturas en el cuerpo. Estos canales son preferentemente rectos. Estos canales presentan un diámetro tal para poder hacer pasar una plastia tendinosa. La operación de estabilizar a nivel proximal de manera anatómica la prótesis con el hueso semilunar se detalla a continuación: According to a preferred embodiment of the invention, these proximal through channels of the prosthesis body are two channels that intersect each other, forming a "T", so that there are three openings in the body. These channels are preferably straight. These channels are of such a diameter to allow a tendon plasty to pass. The operation to anatomically stabilize the prosthesis with the lunate bone at the proximal level is detailed below:
1. Extracción de la parte proximal del hueso escafoides, manteniendo una parte distal sin extraer. 1. Extraction of the proximal part of the scaphoid bone, keeping a distal part not extracted.
2. Perforado en el remanente óseo lado distal del hueso escafoides de un orificio ciego para el paso del elemento de fijación. 2. Drilling a blind hole in the distal side of the scaphoid bone remnant for the passage of the fixation element.
3. Para poder esta estabilizar a nivel proximal de manera anatómica la prótesis con el hueso semilunar, el hueso semilunar previamente se deberá haber perforado por dos aberturas (abertura de dorsal a palmar y abertura desde el lado semilunar hacia confluir con la otra perforación), de modo que el doctor abre dos canales en el hueso semilunar conectados entre sí. 3. To be able to anatomically stabilize the prosthesis with the lunate bone at the proximal level, the lunate bone must have previously been drilled through two openings (opening from dorsal to palmar and opening from the lunate side to converge with the other perforation), so the doctor opens two channels in the lunate bone connected to each other.
4. Se coloca la prótesis parcial. 4. The partial denture is placed.
5. Se ancla la prótesis parcial a nivel distal con un tornillo de fijación retrógrado. 5. The partial denture is anchored distally with a retrograde fixation screw.
6. Se empieza a estabilizar la misma a nivel proximal pasando la plastia por la abertura más dorsal del escafoides y se saca la plastia por el del lado del semilunar. Entonces el doctor introduce la plastia al semilunar por su abertura palmar saliendo por el dorsal. 6. It begins to stabilize it proximally by passing the plasty through the most dorsal opening of the scaphoid and the plasty is removed from the side of the lunate. Then the doctor introduces the plasty to the lunate through its palmar opening, leaving through the dorsal.
7. Después nuevamente el doctor introduce la plastia por la misma abertura dorsal del escafoides y en esta ocasión la saca por la abertura más distal para finalmente suturar el tendón sobre sí mismo sin perder la tracción. 7. Then again the doctor introduces the plasty through the same dorsal opening of the scaphoid and this time takes it out through the most distal opening to finally suture the tendon on itself without losing traction.
Preferentemente, la forma y dimensiones exteriores del cuerpo de la prótesis corresponden sustancialmente a la morfología real de una parte del lado distal mayor al propio polo proximal. Según una realización preferida de la invención, la forma y dimensiones exteriores del cuerpo de la prótesis corresponden sustancialmente a la morfología real de las 2/3 partes del lado proximal del escafoides real retirado de un paciente, mientras que el 1/3 distal restante del escafoides permanece en su sitio sin retirarse. No obstante, se podrá realizar una prótesis parcial de una parte proximal con una porción distinta a las 2/3 partes en tanto en que sea suficiente para permitir la estabilización proximal al semilunar con una plastia a través de los canales transóseo citados anteriormente y permita el paso del tornillo retrógrado que ejerza la estabilización distal. Preferably, the shape and exterior dimensions of the prosthesis body correspond substantially to the actual morphology of a part of the distal side greater than the proximal pole itself. According to a preferred embodiment of the invention, the shape and exterior dimensions of the body of the prosthesis correspond substantially to the actual morphology of the 2/3 parts of the proximal side of the actual scaphoid removed from a patient, while the remaining distal 1/3 of the scaphoid remains in place without retreating. However, a partial prosthesis of a proximal part can be made with a portion other than 2/3 parts as long as it is sufficient to allow proximal stabilization of the lunate with a plasty through the transosseous channels mentioned above and allows the step of the retrograde screw exerting distal stabilization.
El cuerpo de la prótesis presenta un estrechamiento a nivel de la cintura del escafoides resultante, simulando la parte de la cintura del escafoides real retirado. Además presenta una base en el lado distal, sustancialmente plana, de unión con el remanente óseo distal. La forma y dimensiones exteriores del cuerpo de la prótesis dependerán de las formas anatómicas y tamaños que tiene el escafoides de cada paciente. La prótesis se fabrica, preferentemente, en tres tallas distintas, y una prótesis para lado izquierdo y otras para lado derecho. No obstante, se podrá fabricar esta prótesis a medida, según las dimensiones concretas de cada paciente. La misma se podrá fabricar según técnicas de fabricación conocidas, por ejemplo, mediante impresión en 3D. The body of the prosthesis presents a narrowing at the waist level of the resulting scaphoid, simulating the part of the waist of the real scaphoid removed. It also has a base on the distal side, substantially flat, for attachment to the distal bone remnant. The shape and external dimensions of the body of the prosthesis will depend on the anatomical shapes and sizes of the scaphoid of each patient. The prosthesis is manufactured, preferably, in three different sizes, and a prosthesis for the left side and others for the right side. However, this prosthesis can be made to measure, according to the specific dimensions of each patient. It can be manufactured according to known manufacturing techniques, for example by 3D printing.
Tras numerosas mediciones llevadas a cabo por parte de los titulares, se ha visto que las dimensiones exteriores óptimas de la prótesis pueden variar según los siguientes parámetros: longitud del cuerpo de la prótesis desde el extremo proximal al extremo distal sumada a la longitud del remanente óseo comprendida entre 25 y 31 mm. grosor a nivel de la cintura escafoidea de la prótesis está comprendido entre 8 y 1 1 ,9mm. After numerous measurements carried out by the holders, it has been seen that the optimal exterior dimensions of the prosthesis can vary according to the following parameters: length of the prosthesis body from the proximal end to the distal end added to the length of the bone remnant between 25 and 31 mm. thickness at the level of the scaphoid girdle of the prosthesis is between 8 and 1 1, 9mm.
Debido a esta variabilidad en la longitud y grosor, se ha decidido realizado realizar la prótesis de la invención en tres tallas distintas, con el fin de amoldar la prótesis a la mejor anatomía del paciente. Due to this variability in length and thickness, it has been decided to make the prosthesis of the invention in three different sizes, in order to mold the prosthesis to the best anatomy of the patient.
De modo preferente, a nivel interno, el orificio ciego de la prótesis se extiende a lo largo de la prótesis con una longitud total comprendida entre 10 y 20mm. y presenta un diámetro comprendido entre 3 a 4mm., y más preferentemente 3’5mm. Preferably, internally, the blind hole of the prosthesis extends along the prosthesis with a total length between 10 and 20mm. and it has a diameter between 3 to 4mm., and more preferably 3.5mm.
De modo también preferente, los canales proximales de la prótesis presentan un diámetro comprendido entre 2 y 4mm., y más preferentemente entre 2’5 y 3’5mm. Also preferably, the proximal channels of the prosthesis have a diameter of between 2 and 4mm, and more preferably between 2.5 and 3.5mm.
Opcionalmente, la salida del orificio central y de los canales proximales puede ser redondeada o roma, para no dañar la plastia y evitar que se pueda romper o cortar. Optionally, the exit of the central hole and the proximal channels can be rounded or blunt, so as not to damage the plasty and prevent it from breaking or cutting.
Preferentemente, el cuerpo de la prótesis está fabricado por una porción exterior de cerámica biocompatible. Por ejemplo, puede estar formado por una aleación metálica con al menos una porción exterior de cerámica biocompatible. Se puede escoger el carbón pirolítico como cerámica, aunque el uso de otras cerámicas es también posible, por ejemplo la alúmina cerámica que se ha empleado de manera satisfactoria en implantes de mano. El carbón pirolítico es un material totalmente biocompatible, de gran resistencia al deterioro por fricción, prácticamente indestructible y químicamente inerte, sin producir desgaste óseo. Su coeficiente de fricción es muy bajo lo que le permite al implante deslizarse sin producir desgaste óseo a fin de conseguir la menor resistencia. Además, su módulo de Young, idéntico al del hueso, le permite ser perfectamente tolerado. Preferably, the body of the prosthesis is made of an outer portion of biocompatible ceramic. For example, it can be formed of a metallic alloy with at least one outer portion of biocompatible ceramic. You can choose pyrolytic carbon as ceramic, although the use of other ceramics is also possible, for example alumina. ceramic that has been used successfully in hand implants. Pyrolytic carbon is a totally biocompatible material, highly resistant to deterioration by friction, practically indestructible and chemically inert, without causing bone wear. Its coefficient of friction is very low, which allows the implant to slide without causing bone wear in order to achieve the least resistance. Furthermore, its Young's modulus, identical to that of bone, allows it to be perfectly tolerated.
La prótesis de la presente invención se usa, preferentemente, en casos de pseudoartrosis recalcitrante del escafoides, necrosis avascular del mismo, enfermedad de Preiser, fracturas agudas con gran conminución o desplazamiento donde es imposible realizar una reducción anatómica y osteosíntesis primaria, o en casos de artrosis incipiente de la muñeca secundaria a un colapso avanzado por pseudoartrosis del escafoides, siempre que no exista un compromiso de degeneración intercarpiano tipo SNAC III- IV. The prosthesis of the present invention is used, preferably, in cases of recalcitrant pseudoarthrosis of the scaphoid, avascular necrosis thereof, Preiser's disease, acute fractures with great comminution or displacement where it is impossible to perform an anatomical reduction and primary osteosynthesis, or in cases of Incipient osteoarthritis of the wrist secondary to advanced collapse due to scaphoid nonunion, provided there is no compromise of SNAC III-IV type intercarpal degeneration.
Lo más significativo que diferencia a la prótesis de la invención respecto de otros implantes es que queda estabilizada al resto de los huesos del carpo, imitando al escafoides nativo y, por tanto, totalmente integrado con la cinemática carpal. De esta manera, se tiene un implante que sustituye la parte del escafoides no viable pero manteniendo el tercio distal del mismo lo que permite el anclaje protésico y que se comporten como una unidad. Además, la prótesis queda estabilizada también a nivel proximal para recrear al 100% la anatomía y cinemática carpal. The most significant thing that differentiates the prosthesis of the invention from other implants is that it remains stabilized to the rest of the carpal bones, imitating the native scaphoid and, therefore, fully integrated with the carpal kinematics. In this way, there is an implant that replaces the non-viable part of the scaphoid while maintaining the distal third of it, which allows prosthetic anchorage and behaves as a unit. In addition, the prosthesis is also stabilized at the proximal level to recreate 100% carpal anatomy and kinematics.
Gracias a la ventajosa configuración de la prótesis, la hacen única y diferente a lo que actualmente existe en el mercado. Thanks to the advantageous configuration of the prosthesis, they make it unique and different from what currently exists on the market.
Breve descripción de las figuras Brief description of the figures
Para mejor comprensión de cuanto se ha expuesto se acompañan unos dibujos en los que, esquemáticamente y tan sólo a título de ejemplo no limitativo, se representan casos prácticos de diferentes realizaciones. For a better understanding of what has been explained, some drawings are attached in which, schematically and only as a non-limiting example, practical cases of different embodiments are represented.
Las Figuras 1 a 5 representan distintas vistas de una posible realización de la prótesis de la invención, donde se aprecia la forma y dimensiones exteriores, así como también las tres aberturas de los dos canales proximales para el paso de la plastia y la abertura lado distal del orificio central ciego. La Figura 6 representa esquemáticamente los huesos del carpo, en donde el hueso escafoides no se ha retirado. Figures 1 to 5 represent different views of a possible embodiment of the prosthesis of the invention, where the shape and external dimensions can be seen, as well as the three openings of the two proximal channels for the passage of the plasty and the opening on the distal side. the central knockout hole. Figure 6 schematically represents the carpal bones, where the scaphoid bone has not been removed.
La Figura 7 representa esquemáticamente los huesos del carpo en otra posición distinta a la de la Figura 6, en donde la parte más proximal del hueso escafoides se ha retirado y se ha sustituido por la prótesis parcial de la invención y con la plastia introducida. Figure 7 schematically represents the carpal bones in a position other than that of Figure 6, where the most proximal part of the scaphoid bone has been removed and has been replaced by the partial prosthesis of the invention and with the plasty inserted.
Las Figuras 8 y 9 representan esquemáticamente respectivas vistas en detalle de la prótesis de la invención una vez posicionada en un paciente y con la plastia introducida. Figures 8 and 9 schematically represent respective detailed views of the prosthesis of the invention once positioned in a patient and with the plasty inserted.
La Figura 10 representa esquemáticamente una posible realización del tornillo de fijación canulado. Figure 10 schematically represents a possible embodiment of the cannulated fixation screw.
Descripción de unos ejemplos de realización Description of some examples of realization
A continuación, se describen unos ejemplos de realización de la presente invención haciendo referencia a las Figuras 1 a 10. Hereinafter, some embodiments of the present invention are described with reference to Figures 1 to 10.
El comportamiento cinemático de la prótesis (10) de la invención se ha probado empíricamente por parte del titular en cadáveres, con unos resultados satisfactorios. Las pruebas efectuadas fueron: The kinematic behavior of the prosthesis (10) of the invention has been empirically tested by the owner on cadavers, with satisfactory results. The tests carried out were:
En primer lugar, se prepara la pieza del antebrazo de cadáver (con 4 a 6 piezas de especímenes). Se retira casi la totalidad de partes blandas tanto a nivel proximal como distal dejando únicamente cuatro ejes de tracción que corresponden al flexor carpís radialis, flexor carpís lunaris, extensor carpís lunaris y extensor carpís radialis longus y brevis que funcionan conjuntamente. El antebrazo es acoplado a un soporte mediante unos tornillos anclados en cúbito y radio y conectado a un sistema de fotogrametría con varios dinamómetros en los 4 tendones principales que permite aplicar fuerzas de flexo-extensión y desviación radial y cubital y analizarlas. First, the cadaver forearm piece is prepared (with 4 to 6 specimen pieces). Almost all soft tissues are removed both proximally and distally, leaving only four axes of traction that correspond to the flexor carpi radialis, flexor carpi lunaris, extensor carpís lunaris and extensor carpís radialis longus and brevis that work together. The forearm is attached to a support by means of screws anchored in the ulna and radius and connected to a photogrammetry system with several dynamometers in the 4 main tendons that allows to apply flexion-extension forces and radial and ulnar deviation and analyze them.
- A continuación se sustituyen los 2/3 del escafoides carpiano por la prótesis diseñada previamente que es estabilizada y se repite el mismo análisis cinemático. Durante el movimiento se captura todo con cámaras y células de carga para poder extraer los fotogramas y calcular la posición relativa de los marcadores y las fuerzas de tracción, los ángulos de Euler y los centros instantáneos de rotación. - Next, the 2/3 of the carpal scaphoid is replaced by the previously designed prosthesis that is stabilized and the same kinematic analysis is repeated. During the movement everything is captured with cameras and load cells to be able to extract the frames and calculate the relative position of the markers and the tensile forces, the Euler angles and the instantaneous centers of rotation.
Además, se completa el estudio con mediciones radiográficas de los movimientos de flexo- extensión, prono-supinación, lateralización. In addition, the study is completed with radiographic measurements of flexion-extension, prono-supination, and lateralization movements.
Tal y como se muestra en la Figura 6, en donde se representa la situación del carpo en la que no se ha colocado aún la prótesis (10), el hueso escafoides real completo (1) se encuentra dispuesto en el carpo estando en contacto con el trapecio (6), el trapezoide (5), el grande (4), el semilunar (3), y el radio (7). El hueso escafoides (1) presenta una longitud“A” y un grosor a nivel de la cintura“B”, cuyos parámetros dependerán de cada paciente. As shown in Figure 6, where the situation of the carpus is represented in which the prosthesis (10) has not yet been placed, the complete real scaphoid bone (1) is located in the carpus being in contact with the trapezoid (6), the trapezoid (5), the large one (4), the lunate (3), and the radius (7). The scaphoid bone (1) has a length "A" and a thickness at the level of the waist "B", the parameters of which will depend on each patient.
En cambio, en las Figuras 7 a 9 se representa la situación del carpo en la que ya se ha colocado la prótesis (10) de la invención en su sitio, manteniendo el remanente óseo del lado distal del hueso escafoides (2). En dichas Figuras se aprecia como la prótesis (10) queda unida fijamente al remanente óseo (2) mediante un tornillo (en las Figuras 7 a 9 sólo se muestra el orificio (12) mientras que en la Figura 10 se representa el tornillo (18), que se dispone dentro del orificio central ciego (12). A nivel proximal, la prótesis queda estabilizada de manera anatómica con el hueso semilunar (3) mediante una plastia tendinosa (23) con el músculo Flexor Palmar Largo o con el Plantar Delgado. Esta plastia tendinosa (23) se dispone formando dos lazos que atraviesan los canales (16 y 17) siguiendo las operaciones descritas en la parte de la Descripción, y quedando fijada mediante un punto de sutura (22), véase figuras 8 y 9. Preferentemente, el cabo final y el cabo proximal de la plastia (23), una vez se han pasado los dos lazos, se cose sobre la misma plastia (23) ya pasada. On the other hand, Figures 7 to 9 represent the situation of the carpus in which the prosthesis (10) of the invention has already been placed in place, keeping the bone remnant on the distal side of the scaphoid bone (2). In said Figures it can be seen how the prosthesis (10) is firmly attached to the bone remnant (2) by means of a screw (in Figures 7 to 9 only the hole (12) is shown while in Figure 10 the screw (18 ), which is arranged within the central blind hole (12). Proximally, the prosthesis is anatomically stabilized with the lunate bone (3) by means of a tendon plasty (23) with the Flexor Palmar Largo muscle or with the Plantar Delgado This tendon plasty (23) is arranged by forming two loops that pass through the channels (16 and 17) following the operations described in the part of the Description, and being fixed by means of a suture point (22), see Figures 8 and 9. Preferably, the final end and the proximal end of the plasty (23), once the two loops have been passed, are sewn on the same plasty (23) already passed.
Tal y como se aprecia en las Figuras adjuntas 1 a 5, esta realización particular de la prótesis (10) de la invención presenta un cuerpo con una forma y dimensiones exteriores que corresponden sustancialmente a la morfología real de 2/3 partes del lado proximal que han sido previamente retiradas del escafoides de un paciente. Presenta una superficie (1 1) en el lado distal sustancialmente plana, en donde se prevé una abertura (12a) que se prolonga formando el orificio central ciego (12). El cuerpo de la prótesis es sólido y a nivel proximal presenta tres aberturas (13, 14, y 15) que forman dos canales (16, 17) que se interceptan entre sí para el paso de la plastia (23). El primer canal (16) se prolonga desde la primera abertura (13) hasta llegar al segundo canal (17), y este segundo canal (17) se prolonga desde la segunda abertura (14) hasta llegar a la tercera abertura (15). Se puede observar en la Figura 5 cómo estos dos canales se interceptan formando una forma de“T”. As can be seen in the attached Figures 1 to 5, this particular embodiment of the prosthesis (10) of the invention presents a body with a shape and external dimensions that substantially correspond to the real morphology of 2/3 parts of the proximal side that have previously been removed from the scaphoid of a patient. It has a surface (1 1) on the distal side that is substantially flat, where an opening (12a) is provided, which extends to form the central blind hole (12). The body of the prosthesis is solid and at the proximal level it has three openings (13, 14, and 15) that form two channels (16, 17) that intercept each other for the passage of the plasty (23). The first channel (16) extends from the first opening (13) to the second channel (17), and this second channel (17) extends from the second opening (14) until reaching the third opening (15). It can be seen in Figure 5 how these two channels intersect forming a "T" shape.
Volviendo nuevamente a las Figuras 7 a 9, en las mismas se aprecia una posible configuración del orificio central ciego (12) de la prótesis, el cual presenta una rosca (13a) en el extremo proximal del orificio central (13), y en la continuación del orificio central ciego (12). En el remanente óseo (2) se creará sola una segunda rosca que autoterraja al introducir el tornillo retrógrado que es autoperforante y autorroscante (13b). Returning again to Figures 7 to 9, in them a possible configuration of the blind central hole (12) of the prosthesis can be seen, which has a thread (13a) at the proximal end of the central hole (13), and in the continuation of the central blind hole (12). In the bone remnant (2), a second thread will be created that will self-tapping when the retrograde screw is inserted, which is self-drilling and self-tapping (13b).
En la Figura 10 se aprecia una posible configuración del tornillo (18) que se atornilla en el interior del orificio central ciego (12) de la prótesis y de la continuación del orificio central ciego (12) del remanente óseo (2). Dicho tornillo (18) presenta un cuerpo ligeramente cónico, y se caracteriza porque su rosca proximal y distal tienen diferente tamaño y diferente paso de rosca. Así, cuenta con una porción inferior (zona de la cabeza del tornillo) (21) dotada de una rosca de paso mayor y mayor tamaño, una porción intermedia (20) sin rosca, y una porción superior (punta del tornillo) (19) dotada de una rosca de paso menor y menor tamaño, en donde la porción superior (llamado primer paso de rosca) (19) está adaptada para ser roscada en la rosca interior (13a) del orificio (12) la prótesis (10). Figure 10 shows a possible configuration of the screw (18) that is screwed inside the central blind hole (12) of the prosthesis and the continuation of the central blind hole (12) of the bone remnant (2). Said screw (18) has a slightly conical body, and is characterized in that its proximal and distal threads have different size and different thread pitch. Thus, it has a lower portion (screw head area) (21) equipped with a larger and larger thread, an intermediate portion (20) without thread, and an upper portion (screw tip) (19) provided with a smaller pitch and smaller thread, wherein the upper portion (called the first thread pitch) (19) is adapted to be threaded into the internal thread (13a) of the hole (12) of the prosthesis (10).
A pesar de que se ha hecho referencia a una realización concreta de la invención, es evidente para un experto en la materia que la prótesis parcial de escafoides descrita es susceptible de numerosas variaciones y modificaciones, y que todos los detalles mencionados pueden ser substituidos por otros técnicamente equivalentes, sin apartarse del ámbito de protección definido por las reivindicaciones adjuntas. Although reference has been made to a specific embodiment of the invention, it is clear to a person skilled in the art that the partial scaphoid prosthesis described is susceptible to numerous variations and modifications, and that all the mentioned details can be substituted by others. technically equivalent, without departing from the scope of protection defined by the appended claims.

Claims

REIVINDICACIONES
1. Prótesis parcial (10) del hueso escafoides, adaptada para sustituir, tras una exéresis de una parte proximal del escafoides real de un paciente, dicha parte proximal retirada, mientras que la parte restante del escafoides real correspondiente al lado distal permanece en su sitio sin retirarse como remanente óseo (2), caracterizada porque comprende un cuerpo: con una forma y dimensiones exteriores que corresponden sustancialmente a la morfología real de la parte retirada del escafoides correspondiente a una porción del lado proximal del escafoides, que, en el lado distal, comprende un orificio ciego (12) que se extiende a lo largo de la prótesis, donde este orificio ciego (12) comprende como mínimo una porción roscada (13a) para que a través del remanente óseo de escafoides en dirección retrógrada puede pasar un elemento de fijación para estabilizar distalmente la prótesis, que, en el lado proximal, comprende unos canales (16, 17) pasantes para el paso de una plastia tendinosa proximal (23) con una banda del músculo Flexor Palmar Largo o con el Plantar Delgado hasta el hueso semilunar (3), de modo que se estabiliza la prótesis (10) a nivel proximal de manera anatómica con el hueso semilunar (3), y fabricada de un material que comprende un material biocompatible. 1. Partial prosthesis (10) of the scaphoid bone, adapted to replace, after an exeresis of a proximal part of the real scaphoid of a patient, said proximal part removed, while the remaining part of the real scaphoid corresponding to the distal side remains in place without being removed as a bone remnant (2), characterized in that it comprises a body: with a shape and external dimensions that correspond substantially to the actual morphology of the removed part of the scaphoid corresponding to a portion of the proximal side of the scaphoid, which, on the distal side , it comprises a blind hole (12) that extends along the prosthesis, where this blind hole (12) comprises at least one threaded portion (13a) so that an element can pass through the scaphoid bone remnant in a retrograde direction fixation system to distally stabilize the prosthesis, which, on the proximal side, comprises through channels (16, 17) for the passage of a proximal tendon plasty al (23) with a band of the Flexor Palmar Largo muscle or with the Plantar Slim muscle up to the lunate bone (3), so that the prosthesis (10) is anatomically stabilized proximally with the lunate bone (3), and made of a material comprising a biocompatible material.
2. Prótesis (10) de acuerdo a la reivindicación 1 , en la que la forma y dimensiones exteriores del cuerpo corresponden sustancialmente a la morfología real de un parte sustancialmente mayor al polo proximal del escafoides, mientas que la parte distal restante del escafoides permanece en su sitio. Prosthesis (10) according to claim 1, in which the shape and external dimensions of the body correspond substantially to the actual morphology of a part substantially greater than the proximal pole of the scaphoid, while the remaining distal part of the scaphoid remains in your site.
3. Prótesis (10) de acuerdo a la reivindicación 2, en la que la forma y dimensiones exteriores del cuerpo corresponden sustancialmente a la morfología real de las 2/3 partes del lado proximal del escafoides real retirado de un paciente, mientas que el 1/3 distal restante del escafoides permanece en su sitio. Prosthesis (10) according to claim 2, in which the shape and external dimensions of the body correspond substantially to the actual morphology of the 2/3 parts of the proximal side of the actual scaphoid removed from a patient, while the 1 Remaining distal / 3 of the scaphoid remains in place.
4. Prótesis (10) de acuerdo a la reivindicación 1 , en la que los canales (16, 17) pasantes son dos que convergen entre sí formando una“T”, de manera que hay tres aberturas (13, 14 y 15) en el cuerpo. Prosthesis (10) according to claim 1, in which the through channels (16, 17) are two that converge together forming a "T", so that there are three openings (13, 14 and 15) in the body.
5. Prótesis (10) de acuerdo a la reivindicación 1 , en la que además comprende un tornillo canulado (18) a modo de elemento de fijación, el cual presenta una longitud comprendida entre 18 y 26 mm. 5. Prosthesis (10) according to claim 1, in which it also comprises a cannulated screw (18) as a fixation element, which has a length between 18 and 26 mm.
6. Prótesis de acuerdo a la reivindicación 1 , en la que la porción roscada (13a) del orificio ciego (12) está dispuesta en el extremo proximal del orificio central (12). Prosthesis according to claim 1, in which the threaded portion (13a) of the blind hole (12) is arranged at the proximal end of the central hole (12).
7. Prótesis (10) de acuerdo a la reivindicación anterior, en la que la porción roscada (13a) del orificio ciego (12) comprende una rosca en el extremo proximal con un paso de rosca menor, y en el remanente óseo del escafoides (2) asienta una segunda rosca con un mayor paso de rosca, para permitir ejercer compresión en el momento de posicionar el escafoides. Prosthesis (10) according to the preceding claim, in which the threaded portion (13a) of the blind hole (12) comprises a thread at the proximal end with a smaller thread pitch, and in the bone remnant of the scaphoid ( 2) Seats a second thread with a greater thread pitch, to allow for compression when positioning the scaphoid.
8. Prótesis (10) de acuerdo a la reivindicación 1 , en la que el cuerpo está fabricado por una aleación metálica con al menos una porción exterior de cerámica. Prosthesis (10) according to claim 1, in which the body is made of a metallic alloy with at least one outer portion of ceramic.
9. Prótesis (10) de acuerdo a la reivindicación anterior, en la que se escoge el carbón pirolítico como cerámica. 9. Prosthesis (10) according to the preceding claim, in which pyrolytic carbon is chosen as the ceramic.
10. Prótesis (10) de acuerdo a la reivindicación 1 , en la que la parte (1 1) de la prótesis que contacta con el remanente de hueso del escafoides (2) comprende un material rugoso, es decir no pulido, para conseguir la osteointegración con el remanente de hueso y evitar los micromovimientos. 10. Prosthesis (10) according to claim 1, in which the part (1 1) of the prosthesis that contacts the bone remnant of the scaphoid (2) comprises a rough material, that is to say not polished, to achieve the osseointegration with the bone remnant and avoid micromotion.
1 1. Prótesis (10) de acuerdo a la reivindicación 1 , en que la longitud del cuerpo de la prótesis desde el extremo proximal al extremo distal sumado al del remanente óseo (2) está comprendida entre 25 y 31 mm. 1 1. Prosthesis (10) according to claim 1, in which the length of the prosthesis body from the proximal end to the distal end added to that of the bone remnant (2) is between 25 and 31 mm.
12. Prótesis (10) de acuerdo a la reivindicación 1 , en la que el orificio ciego (12) se extiende a lo largo de la prótesis (10) con una longitud total comprendida entre 10 y 20 mm. 12. Prosthesis (10) according to claim 1, in which the blind hole (12) extends along the prosthesis (10) with a total length between 10 and 20 mm.
13. Prótesis (10) de acuerdo a la reivindicación 1 , en la que el cuerpo presenta un estrechamiento a nivel de la cintura del escafoides resultante, donde el escafoides resultante es el conjunto de la prótesis proximal más la parte distal remanente en el paciente. 13. Prosthesis (10) according to claim 1, in which the body has a narrowing at the waist of the resulting scaphoid, where the resulting scaphoid is the set of the proximal prosthesis plus the distal part remaining in the patient.
14. Prótesis (10) de acuerdo a la reivindicación anterior, en la que el grosor del cuerpo de la prótesis (10) a nivel de la cintura escafoidea está comprendido entre 8 y 11 ,9mm. Prosthesis (10) according to the preceding claim, in which the thickness of the body of the prosthesis (10) at the level of the scaphoid girdle is between 8 and 11.9mm.
15. Uso de la prótesis de acuerdo a una cualquiera de las reivindicaciones 1 a 14, en los casos de pseudoartrosis recalcitrante del escafoides, necrosis avascular del mismo, enfermedad de Preiser, fracturas agudas con gran conminución o desplazamiento donde es imposible realizar una reducción anatómica y osteosíntesis primaria, o en casos de artrosis incipiente de la muñeca secundaria a un colapso avanzado por pseudoartrosis del escafoides, siempre que no exista un compromiso de degeneración intercarpiano tipo SNAC III- IV. 15. Use of the prosthesis according to any one of claims 1 to 14, in cases of recalcitrant pseudoarthrosis of the scaphoid, avascular necrosis thereof, Preiser's disease, acute fractures with great comminution or displacement where it is impossible to perform an anatomical reduction and primary osteosynthesis, or in cases of incipient osteoarthritis of the wrist secondary to advanced collapse due to scaphoid pseudoarthrosis, provided there is no compromise of SNAC III-IV type intercarpal degeneration.
PCT/ES2020/070078 2019-02-08 2020-02-03 Partial prosthesis for the scaphoid bone WO2020161374A1 (en)

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Cited By (1)

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Publication number Priority date Publication date Assignee Title
CN112137767A (en) * 2020-09-18 2020-12-29 湖南普林特医疗器械有限公司 Integrated replacement scaphoid used in orthopedic surgery and matched processing and mounting method

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Publication number Priority date Publication date Assignee Title
GB2032782A (en) * 1978-10-13 1980-05-14 Dow Corning Scaphoid implant
WO1998056318A1 (en) * 1995-03-09 1998-12-17 Robert Goldberg Biaxial ligamentous-restrained prostheses for upper and lower extremity arthroplasties

Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
GB2032782A (en) * 1978-10-13 1980-05-14 Dow Corning Scaphoid implant
WO1998056318A1 (en) * 1995-03-09 1998-12-17 Robert Goldberg Biaxial ligamentous-restrained prostheses for upper and lower extremity arthroplasties

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112137767A (en) * 2020-09-18 2020-12-29 湖南普林特医疗器械有限公司 Integrated replacement scaphoid used in orthopedic surgery and matched processing and mounting method
CN112137767B (en) * 2020-09-18 2024-04-12 湖南华翔医疗科技有限公司 Integrated replacement navicular bone used in orthopedic operation and matched machining and installing method

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