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    • 专利摘要:
    STABILIZING PLATE. According to an aspect of the invention, an anterior cervical plate (121) is provided, the anterior cervical plate comprising a plate part (122) for stabilizing a human or animal spine being located ventrally in the spinal column and being fixed in two or more different vertebral bodies, and further comprising a plurality of fixation parts adapted to be anchored in different vertebral bodies, at least one of one of the fixation parts (124) being rigidly connected to the plate part and comprising an element of sheath with a longitudinal opening that is accessible from a proximal side and at least one hole (14) that reaches from the longitudinal opening outwards, the anterior cervical plate additionally comprising a sheath element with an inserted thermoplastic element (21) or insertable in the sheath element and capable of being liquefied, for example, by the mechanical energy acting in the thermoplastic element, in which the The hole is positioned so that the liquefied thermoplastic material is pressed through the hole into the bone tissue of the vertebral body in which the fixator is to be anchored, in which at least one fixation part comprises a capable stabilization structure (.. .).
    公开号:BR112013007137B1
    申请号:R112013007137-0
    申请日:2011-09-22
    公开日:2021-01-26
    发明作者:Jörg Mayer；Andreas Wenger
    申请人:Spinewelding Ag.；
    IPC主号:
    专利说明:

    [0001] The present invention is in the field of medical technology. In particular, it refers to an anterior cervical plaque and an anterior cervical plaque system. Fundamentals of the Invention
    [0002] If screws are anchored in living bone tissue, often the problem of insufficient bone stability or insufficient stability of bone anchoring arises. Especially in trabecular bone tissue, any load action on the screw is passed to only a few trabeculae, with adverse consequences both for the load-bearing capacity of the screw-bone connection and for its long-term stability. This is especially severe in osteoporotic or osteopenic bone tissue or in some other way weakened.
    [0003] One solution to this problem is the use of an alternative anchoring method that is also suitable for the fabric on which the screws are not stable. The publications WO 02/069817, WO 2004/017 857, WO 2008/034 277 and WO 2009/055 952 refer to the anchoring of an implant in bone tissue with the aid of mechanical vibration and a thermoplastic material that is liquefied by mechanical vibration That is, the thermoplastic material is capable of being liquefied when vibrated and simultaneously kept in contact with a non-vibrating surface. The thermoplastic material, in contact with the bone tissue, is liquefied and pressed into the pores or cavities of the bone tissue to constitute, when again solidified, a positive fitting connection with the bone tissue.
    [0004] A special group of implant modalities and implant anchoring processes is based on the material that can be liquefied by being inserted (pre-assembled or inserted in situ) into a longitudinal opening of a sheath element. The sheath element comprises at least one hole in the wall of the sheath element, through which the liquefied material is pressed from the longitudinal opening within the structures (pores or cavities or other structures) of the bone tissue or other hard tissue or material of replacement of hard tissue where anchoring is desired. This principle of pressing the liquefied material out of a tube or sleeve element with side openings is, for example, described in US 7,335,205, US 6,921,264, WO 2009/055 952, WO 2009/010247, WO 2009 / 010234 and PCT publication No. PCT / CH 2009/000138, all of which are incorporated herein by reference. Summary of the Invention
    [0005] The invention relates to a surgical stabilizer plate. Such a plate comprises a plate part and a plurality of fastening parts, at least one of one of the fastening parts (and, for example, all) being rigidly connected to the plate part and comprising a sheath element with a longitudinal opening that it is accessible from a proximal side and at least one hole that reaches from the longitudinal opening to the outside. The stabilizer plate additionally comprises, by sheath element, a thermoplastic element inserted or that can be inserted in the sheath element and capable of being liquefied, for example, by the action of mechanical energy in the thermoplastic element.
    [0006] In a group of modalities, the at least one hole is a radial hole. The radial hole / holes can be arranged at a location other than the distal end of the respective fixation part, but the fixation parts can be distal with respect to the radial holes comprising a stabilizing part.
    [0007] An axial extension of the stabilizing part can be substantial; for example, it can be at least two thirds of a distance between the plate part and the radial holes, or equal to or greater than the distance between the plate part and the radial holes. The stabilizing part may have a non-circular cross section. The distance between the plate part and the radial hole is, for example, adjusted so that the liquefied material pressed out through the radial hole into the surrounding bone tissue after further solidification provides a subcortical anchorage of the ACP.
    [0008] An example of such a stabilizing plate is an anterior cervical plate (ACP), in which the plate part can stabilize a human or animal column being located anteriorly (ventrally) in relation to the spinal column and being affixed to two or more different vertebral bodies. The fixation parts are, therefore, intended to be anchored in different vertebral bodies.
    [0009] According to one aspect of the invention, an anterior cervical plate (ACP) is provided, the ACP comprising a plate portion for stabilizing a human or animal spine being located ventrally with respect to the spinal column and being attached to two or more different vertebral bodies, and further comprising a plurality of fixation parts adapted to be anchored in different vertebral bodies. At least one of the fixing part is rigidly connected to the plate part and comprises a sheath element with a longitudinal opening that is accessible from a proximal side and at least one hole that reaches from the longitudinal opening outwards. The anterior cervical plate additionally comprises, by sheath element, a thermoplastic element inserted in the sheath element and capable of being liquefied, for example, by mechanical energy acting on the thermoplastic element, in which the hole is positioned so that the liquefied thermoplastic material is pressed through the hole into the bone tissue of the vertebral body in which the fixator must be anchored, in which at least one fixation part comprises a stabilizing structure capable of absorbing mechanical loads in the Anterior Cervical Plate.
    [0010] After, for example, mechanical vibration, in particular, the energy stops pushing into the thermoplastic element, the liquefied material pressed into the bone tissue solidifies again and, in this way, provides an anchor for the fixation part and, thus, for the the ACP.
    [0011] In a group of modalities, the at least one hole - or at least one of the holes - is a radial hole.
    [0012] The stabilizing effect of the stabilizing structure is an effect in addition to the anchoring effect of the thermoplastic material. For this purpose, the fastening parts according to a first option comprise structural features that deviate from a purely rotating cylinder. For example, the fastening parts may have a greater extent in the transverse direction than in the upper / lower direction. In addition to or as an alternative to the first option, the fastening parts according to a second option may comprise a distal hole stabilization part since the radial hole / holes are not arranged at a distal end of the respective fixation part. The stabilizing part may have a non-circular cross section and may, for example, have a greater extension in the lateral (or transverse) direction than in the upper-lower (cranial-caudal) direction.
    [0013] Radial holes can be positioned to ensure subcortical anchoring. Generally, a more subcortical anchorage can, for example, be achieved if a distance between an external surface of the bone tissue and the proximal end of an opening through which the anchoring material exits the elongated cavity is, for example, from 2 mm to 7 mm, especially between 3.5 mm and 5.5 mm (these being quantities that refer to adults). Accordingly, a distance between a distal end face of the plate part and the proximal onset of the opening can be chosen so that it is of the same order, that is, between 2 mm and 7 mm, especially between 3.5 mm and 5, 5 mm.
    [0014] A length (near-distal extension) of the openings through which the anchor material comes out can be between 1 mm and 6 mm, especially between 2.5 mm and 5 mm. Experiments with subcortical anchoring (in the vertebral body's bone tissue) have shown that for a plurality of (for example, four) holes equally distributed in the circumferential dimension, a ring of anchor material of a near-distal extension corresponding to the extension of anchoring of the openings and a diameter of 10 mm surrounding a tube element of 4 mm in diameter can be obtained.
    [0015] In modalities dealing with spine stabilization devices having an intervertebral spacer and with respect to a lateral extension of the vertebral body, subcortical anchoring can be achieved if the depth at which the anchoring material exits is between about 5% and 20% of the extension of the vertebral body.
    [0016] In addition to the fastening parts with a longitudinal opening, the stabilizer plate may comprise conventional fasteners.
    [0017] In a special embodiment, the stabilizer plate (for example, ACP) comprises four fastening parts of the type described above being rigidly connected to the plate part and comprising a longitudinal opening and at least one hole (for example, two, three or four openings) axial positions in approximately equal axial positions) from the longitudinal opening outward. If the stabilizer plate is an ACP, the fixation parts are then positioned to be added into the vertebral bodies of two neighboring vertebrae - two in each.
    [0018] In another special embodiment, the stabilizer plate comprises four, five or six fixing parts of the type described above, being rigidly connected to the plate part and comprising a longitudinal opening and at least one hole (for example, two, have or four radial openings in approximately equal axial positions) from the longitudinal opening outward. The ACP in this modality reaches through three neighboring vertebrae, and the fixation parts are then positioned to be activated into the vertebral bodies of at least the upper and lower part of the three vertebrae, and possibly in the vertebral bodies of all three vertebrae. .
    [0019] Instruments for implanting the stabilizer plate may comprise a template that defines the positions of the notches to be made in the bone tissue in positions corresponding to the positions of the fixation parts. According to a first option, the notches can be prefabricated holes, where the template serves to guide the drill that makes the holes. According to a second option, only the cortical bone is removed or pre-drilled (or otherwise prepared) in the places where the fixation parts must penetrate the bone tissue, for example, with a drill or other instrument guided by the template . According to an additional option, the fixation parts, then having a sharp point, can be used to penetrate the cortical bone and advance into the tissue; the template (if any) can be used to directly guide the stabilizer plate during implantation (hammering).
    [0020] The fixing parts, comprising a plurality of radial holes through which the liquefied thermoplastic material can be pressed, can be configured to comprise a direction structure structured in an angled manner with respect to a longitudinal geometric axis of the longitudinal opening to direct the parts different from the liquefied material for different radial holes. Such targeting structures can be of the type described in WO 2011/054122.
    [0021] In embodiments with a plurality of radial holes, these radial holes through which the liquefied material flows out during implantation, may be in the same axial position, or may be in different axial positions. The angular positions can be evenly distributed around the circumference. In the special embodiments, the angular positions can have a deviation distribution adapted to a particular need. For example, if the implant is intended to be an implant to fuse two joint parts, and to be inserted into a joint space, the PDT holes (if more than one) will be concentrated on opposite sides to be in contact with the areas of joint.
    [0022] The general shape of the plate part can be strapped where the waist is formed between the vertebral bodies, and where the fasteners are located in the corners. Here, "strapped" means that a transverse extension of the plaque part in a central region (for example, between the vertebrae to which the ACP is anchored) is less than a transverse extension at the upper / lower end and is, for example, less than a transverse distance between the geometry axes of the fastening parts. This may imply that the fixation parts are located in the locations of the ACP that have the greatest distance from the sagittal plane. This serves the purpose of providing a minimum of side plate extension along with maximum lateral fold and twist prevention / absorption capacity.
    [0023] In a special embodiment, the anterior cervical plate comprises a portion of the plate with exactly four fixation parts, one fixation part in each corner. Here, the fastening parts are of the type described above and are integral with the plate part. The anterior cervical plate can additionally comprise a - initially separated - thermoplastic element by means of the fixation part, the shape of the adaptive thermoplastic element to be introduced into the longitudinal opening of the respective fixation part. The plate part can be folded towards the dorsal side at the corners that hold the fixing parts.
    [0024] The plate part does not have to be flat, nor does it need to have another particular shape, such as, for example, translation symmetry. Instead, it is a particular advantage of the one-piece (integral) construction of the plate part with the fixing parts that the plate part can be shaped according to the user's needs. For example, it can be formatted to assume mechanical loads in a desired way. Mechanical reinforcements can, for example, have the shape of ribs, protrusions, etc. Additionally or alternatively, the plate part can be shaped to be adapted to the geometry and dimensions of bone and to have a minimum depth away from the vertebral bodies. As a particular example, the anterior cervical plaque can be folded in the dorsal direction near the sagittal plane to minimize irritation of the esophagus or sensitive soft tissue structures.
    [0025] According to a further aspect, the invention thus relates to an anterior cervical plate comprising a portion of a plate to stabilize a human or animal spine being located ventrally from the spine column and being affixed to two or more different vertebral bodies , and further comprising a plurality of fixation parts adapted to be anchored in different vertebral bodies, the fixation parts being rigidly connected to the plate part and comprising a sheath element with a longitudinal opening that is accessible from a proximal side and at least one hole that reaches from the longitudinal opening outwards, in which the hole is positioned so that the liquefied thermoplastic material is pressed through the hole into the bone tissue of the vertebral body in which the fixator needs to be anchored, in which one or both of the following conditions are met: the plate part is not flat (it is uneven) the external contour of the fastening parts does not have a rotating cylindrical symmetry.
    [0026] The characteristic that the external contour of the "fastening parts" does not have a rotating cylindrical symmetry in this context implies that the shape of the fastening parts is different from rotationally cylindrical in addition to holes (for example, radial). In particular, the fixing part may have a non-circular external contour and / or it may have at least one trench or the like.
    [0027] In particular, at least a plurality of holes can be radial holes, and the fastening parts can comprise a stabilizing part distal to the radial holes, the stabilizing part having a greater extent in the transverse direction than in the upper / lower direction. The plate part can be strapped according to the definition provided above. The fixing parts can be carried by the edges of the plate part, and the edge parts can be optionally folded to the dorsal side. The plate part may comprise projections or reinforcement ribs.
    [0028] In addition, according to the additional aspect, the anterior cervical plate may additionally comprise a sheath element, a thermoplastic element inserted in the sheath element and capable of being liquefied, for example, by the mechanical energy acting on the thermoplastic element.
    [0029] In other embodiments, the stabilizer plate, instead of being an ACP, can be a fracture stabilizer or post-osteotomy plate. Osteotomy is a surgical procedure in which a bone is cut in order to be shortened, lengthened or realigned. Osteotomy is performed on human and animal patients basically for realigning the load-bearing surfaces in joints and for realigning bone parts in particular in the facio-maxillary region, but also to realign the healed bone parts together with an unwanted alignment with respect to each other after a fracture. The bone parts separated by the osteotomy procedure basically need to be realigned in a desired position with respect to each other and stabilized in that position in order to be able to heal joints again. According to the state of the art, osteotomy sites are usually stabilized with the aid of plates (for example, metal plates) that are positioned on the bone surface by cutting the osteotomy and are fixed in that position with the aid of screws or nails for bone. Simple bone fractures are stabilized in this way.
    [0030] In particular, the stabilizer plate can be used to stabilize fractures or bone cuts close to human or animal joints, where conventional plates are sometimes not easy to fix since the anchorage of conventional surgical screws is weak. For example, if the plate should extend from a bone part in a joint to a bone part remote with respect to the joint, the anchors of the plate that are closest to the joint may be fastening parts of the type described above, whereas for anchoring in remote bone parts of conventional joint fixation surgical screws can be used. Alternatively, all fastening parts can be of the type described above with longitudinal coverage and elements of thermoplastic material.
    [0031] In addition, the stabilizer plate is generally advantageous in situations where there is too little soft tissue to cover the plate (as a consequence, conventional metal surgical screws tend to cause irritation).
    [0032] A special application of a stabilizer plate is stabilization after osteotomy of the tibial plateau, especially for human, canine or feline patients.
    [0033] Mechanical vibration or oscillation suitable for devices and methods according to the modalities of the invention which include liquefaction of a polymer by frictional heat created by mechanical vibration preferably has a frequency between 2 and 200 kHz (even more preferably between 10 and 100 kHz , or between 20 and 40 kHz) and a vibration energy of 0.2 to 20 W per square millimeter of active surface. The vibrating element (sonotrode) is, for example, designed so that its contact face oscillates predominantly in the direction of the geometric axis of the element (longitudinal vibration) and with an amplitude of between 1 and 100 µm, preferably around 10 to 30 µm. Rotational or radial oscillation is also possible.
    [0034] For specific types of devices, it is also possible to use, instead of mechanical vibration, a rotating movement to create the so-called frictional heat necessary for the liquefaction of the anchoring material. Such a rotary movement preferably has a speed in the range of 10,000 to 100,000 rmp. An additional way of producing thermal energy for the desired liquefaction comprises the electromagnetic radiation of coupling in one of the device parts to be implanted and the design of one of the device parts to be able to absorb the electromagnetic radiation, in which such absorption occurs preferably within the anchoring material to be liquefied or in the immediate vicinity thereof. Preferably electromagnetic radiation in the visible or infrared frequency range is used, where the preferred radiation source is a corresponding laser. Electric heating of one of the device parts may also be possible.
    [0035] In this text the expression "thermoplastic material being liquefied, for example, by mechanical vibration" or in short "liquefied thermoplastic material" or "liquefied material" is used to describe a material comprising at least one thermoplastic component, which material becomes liquid or fluid when heated, in particular when heated through friction, that is, when disposed on one of a pair of surfaces (contact faces) in contact with each other and moved in a vibratory or rotating manner with respect to each other, in that the frequency of vibration is between 2 kHz and 200 kHz, preferably between 20 and 40 kHz and the amplitude between 1 μm and 100 μm, preferably around 10 to 30 µm. Such vibrations are, for example, produced by ultrasonic devices as, for example, known for dental applications. In order to provide a load-bearing connection for the fabric, the material has an elasticity coefficient of more than 0.5 GPa, preferably more than 1 GPa. The elasticity coefficient of at least 0.5 GPa also ensures that the liquefied material can transmit ultrasonic oscillation with little damping so that internal liquefaction and, thus, the destabilization of the liquefied element does not occur, that is, liquefaction occurs only when the liquefied material is in the liquefaction interface for the stop face. The plasticization temperature is preferably up to 200 C, between 200 C and 300 C or even more preferably 300 C. Depending on the application, the liquefied thermoplastic material may or may not be reabsorbed.
    [0036] Suitable resorbed polymers are, for example, based on lactic acid and / or glycolic acid (PLA, PLLA, PGA, PLGA, etc.) or polyhydroxyalkanoates (PHA), polycaprolactones (PCL), polysaccharides, poly-dioxanones (PD) , corresponding polyanhydrides, polypeptides, or copolymers or mixed polymers or composite materials containing the polymers mentioned as components are suitable as resorbable liquefied materials. Thermoplastics such as, for example, polyolefins, polyacrylates, polymethylacrylates, polycarbonates, polyamides, polyesters, polyurethanes, polysulfones, polyaryl ketones, polyimides, polyphenyl sulfides or liquid crystal polymers (LCPS), polyacetals, halogenated polymers, in halogenated polymers, particularly halogenated polyolefins, polyphenylene sulfides, polysulfones, polyethers, polypropylene (PP), or corresponding copolymers or mixed polymers or composite materials containing the polymers mentioned as components are suitable as non-resorbable polymers. Examples of suitable thermoplastic material include any of the polylactide products LR708 (Amorphous Poly-L-DL 70/30), L209 or L210S by Böhringer Ingelheim.
    [0037] Specific modalities of degradable materials are Polylacti-des such as LR706 PLDLLA 70/30, R208 PLDLA 50/50, L210S and PLLA 100% L, all from Böhringer. A list of suitable degradable polymeric materials can also be found at: Erich Wintermantel und Suk-Woo Haa, "Medizinaltechnik MIT biokompatiblen Materialien und Verfahren", 3. Auflage, Springer, Berlin 2002 (hereinafter referred to as "Wintermantel"), page 200 ; for information on PGA and PLA see pages 202 ff., on PCL see page 207, on PHB / PHV copolymers page 206; in polydioxanone PDS page 209. Discussion of additional bioreabsorbed material can, for example, be found in CA Bailey et al, J Hand Surg [Br] 2006 April; 31 (2); 208-12.
    [0038] Specific modalities of non-degradable materials are: Po-lyetherketone (PEEK Optima, Degrees 450 and 150, Invibio Ltd), Polyetherimide, Po-liamide 12, Polyamide 11, Polyamide 6, Polyamide 66, Polycarbonate, Polymethylmethylacrylate, Polyoxymethylene, or polycarbonateurethane (in particular Biona-te® by DSM, especially Bionate 75D and Bionate 65D; according to information available in publicly accessible reports, for example, via WWW.matweb.com by Automation Creations, Inc.). An overview table of polymers and applications is listed in Wintermantel, page 150; specific examples can be found at Wintermantel, page 161 ff. (PE, Hostalen Gur 812, Höchst AG), pages 164 ff. (PET) 169ff. (PA, that is, PA 6 and PA 66), 171 ff. (PTFE), 173 ff. (PMMA), 180 (PUR, see table), 186 ff. (PEEK), 189 ff. (PSU), 191 ff. (POM - Poliacetal, trademarks Delrin, Tenac, has also been used in endoprostheses by Protec).
    [0039] The liquefied material having thermoplastic properties may contain foreign phases or compounds serving additional functions. In particular, the thermoplastic material can be reinforced by mixed fillings, for example, particulate fillers which can have a therapeutic or other desired effect. The thermoplastic material can also contain components that expand or dissolve (create pores) in situ (for example, polyesters, polysaccharides, hydrogels, sodium phosphates) or compounds to be released in situ and having a therapeutic effect, for example, promotion healing and regeneration (for example, growth factors, antibiotics, inflammation inhibitors, or stored such as sodium phosphate or calcium carbonate against adverse effects of acidic decomposition). If the thermoplastic material is reabsorbed, the release of such compounds is delayed.
    [0040] If the liquefied material is liquefied not with the aid of vibration energy, but with the aid of electromagnetic radiation, it may contain locally compounds (particulate or molecular) that can absorb such radiation from a specific frequency range (in particular frequency range) visible or infrared), for example, calcium phosphates, calcium carbonates, sodium phosphates, titanium oxide, mica, saturated fatty acids, polysaccharides, glucose or mixtures thereof.
    [0041] Fillers used may include bone degradable fillers to be used in degradable polymers including: β-Tricalciumphosphate (TCP), hydroxyapatite (HA, <90% crystallinity; or mixtures of TCP, HA, DHCP, Bio-glass (see Wintermantel). of bone integration stimuli that are only partially or hardly degradable, for non-degradable polymers include: Bio-glass, hydroxyapatite (> 90% crystallinity), HAPEX®, see SM Rea et al., J. Mater Sci Mater Med. 2004 September; 15 (9): 997-1005; for hydroxyapatite see also L. Fang et al, Biomaterials 2006 July; 27 (20): 3701-7, M. Huang et al., J. Mater Sci Mater Med 2003 July ; 14 (7): 655-60, and W. Bonfield and E. Tanner, Materials World 1997 January; 5 No. 1: 18-20. The modalities of bioactive fillers and salt discussion can, for example, be found in X. Huang and X. Miao, J. Biomater App. 2007, April; 21 (4): 351 -74), ALREADY Juhasz et al. Biomaterials, 2004 March; 25 (6): 949-55. The types of particulate filling include: coarse type: 5 to 20 μm (content, preferably 10 to 25% by volume), submeron (nano-fill as precipitation, preferably plate-like appearance ratio> 10, 10 to 50 nm, content 0 , 5 to 5% by volume).
    [0042] A specific example of a material with which the experiments were carried out was PLDLA 70/30 comprising 30% (weight percentage) biphasic Ca phosphate which showed a particularly advantageous liquefaction behavior.
    [0043] The ACP material can be any material that does not melt at melting temperatures of the liquefied material. In particular, the sheath element may be metal, for example, a titanium alloy. A preferred material is grade 5 titanium. This material, in addition to being generally suitable for implantable devices, has a comparatively low heat conduction. Due to this bad heat conduction, the melting zone that appears in the liquefied material is heated quickly, without the surroundings being heated to very high temperatures. Alternative materials for ACP or other metals such as other titanium alloys, stainless steel or hard plastics such as PEEK, etc. Brief Description of Drawings
    [0044] In the following, embodiments of the invention and modalities are described with reference to the drawings. The drawings are basically schematic. In the drawings, the same numerical references refer to the same or analogous elements. The drawings illustrate: Figure 1 is a modality of an anterior cervical plate (ACP); Figure 2 is a variation of the modality of Figure 1; partially in section: Figure 3 schematically illustrates the use of a modality of an anterior cervical plate; Figure 4 is a schematic cross section of an anterior cervical plate with an esophagus; Figures 5a to 5d are an embodiment of an anterior cervical plate with reinforcement strips; Figure 6 is an asymmetric anterior cervical plate in use; Figures 7a and 7b are distal and proximal ends, respectively, of an alternative fixation part; Figures 8 and 9 are regions of the distal end of additional variations of the fixation parts; and Figure 10 is an alternative embodiment of an anterior cervical plate. Description of Preferred Modalities
    [0045] In Figures 1 and 2, an anterior cervical plate (ACP) 121 is shown. The ACP has a plate portion 122 for stabilizing a human (or animal) spine, being located anteriorly (ventrally) in relation to the spinal column and being affixed to two different (or more) vertebral bodies. The plate portion may be of a shape of a type known in the art that can be adapted to the particular needs of the patient. For example, in contrast to the embodiment shown, the plate part may comprise holes shaped according to biomechanical considerations to provide some elasticity for certain movements while providing a desired stiffness against other movements.
    [0046] In the embodiment of Figure 1, the plate part has two holes 123 with an internal thread that can serve to maintain the plate during the surgical operation, while the variation in Figure 2 has two holes 123 without any thread. In addition to this difference, the modalities of Figures 1 and 2 can be identical.
    [0047] ACP can be used to stabilize a section of the human spine with or without an interbody fusion implant between two bodies of vertebrae. Especially, ACP can be used in connection with an intercorporeal fusion implant as described in WO 2010/096942 incorporated herein by reference.
    [0048] Thermoplastic elements 21 can initially separate from the fastening parts. In the presented modality, they have a rotating cylinder shape, but other shapes - adapted to the shape of the longitudinal opening - are possible.
    [0049] In Figure 1, also the longitudinal geometric axis 11 (which, after the operation, is intended to be parallel to the longitudinal geometric axis (cranial-caudal; upper-lower) of the vertebrae and, thus, to the sagittal plane) and the axis transversal geometric 12 (which after the implant should be parallel to the lateral geometric axis (left-right / mediolateral) of the patient's body) of the ACP are presented. In the present text, the directions "longitudinal", "transversal / lateral", "dorsal" and "ventral" generally refer to the geometric axes and directions when the ACP is located in the body in the intended way.
    [0050] In addition to the plate part 122, the ACP has a plurality of (four in the modality shown) fixing parts 124. Each fixing part is rigidly connected to the plate part 122 and, for example, a (integral) part with the same . Each fastening part is shaped like a sheath element (tube element) with a longitudinal opening that is accessible from the proximal side and at least one radial hole 14 (two holes in the configuration shown) through which, after liquefaction , especially by mechanical energy, the thermoplastic material can be pressed for anchoring.
    [0051] The radial holes 14 are arranged at a distance from the plate that guarantees subcortical anchoring.
    [0052] The presented embodiment comprises, in addition to the radial holes 14, a distal, axial hole 19 per tube element. The purpose of the distal, axial hole 19 is the same as the corresponding distal, axial hole of the modalities described above. In the alternative embodiments - described in greater detail below - only one distal hole is present in at least one fixation part 124 instead of a radial hole.
    [0053] In the illustrated embodiment, the fastening parts 124 comprise, in a distal manner from the radial openings 14, a substantial extension serving as additional stabilizers. In particular, the main load, acting on an ACP, is initiated by flexions along the longitudinal geometric axis of the spinal column, which will cause forces in the up-down direction (in the orientation of the Figure) at the distal ends of the fixation parts. The greater distal extension helps to absorb such loads.
    [0054] Additionally or alternatively, the fastening parts may comprise wings 126 that extend in the lateral directions. Such wings or other deviations from a circular shape can be advantageous - especially if they make the transverse extension (extension in a direction perpendicular to the direction connecting neighboring vertebrae) greater than the upper-lower extension (extension in the direction along the geometric axis location of the spinal column / cranial-caudal geometric axis) - so that again the loads arising from the spinal column flexions can be ideally absorbed.
    [0055] Also for applications other than the application as an ACP, such as non-circular cross sections of the additional stabilizers can be advantageous - depending on restrictions on the lengths of the fastening parts and the loads to be carried by the stabilizer plate.
    [0056] In addition, as an alternative to the presented configuration, it may be advantageous to make the fastening parts less rigid and more flexible than the tube shape often very rigid, for example, making it the same as a blade. Too high stiffness can be problematic in situations where it is not desirable to fully transmit each impulse acting on the fixator in the bone trabeculae, but to absorb part of it by some elasticity of the fixator. A blade shape can be more flexible than a tube shape. In addition, a blade shape, for which no opening in the bone tissue needs to be prefabricated during surgical insertion, is less than an exposure of the bone tissue than a tube shape reaching more distally would be.
    [0057] The fastening parts or at least one of the fastening parts can be shaped according to the first aspect of the invention, that is, the tube elements or at least one of the tube elements can comprise a targeting structure that is structured in a way angled with respect to a longitudinal geometric axis of the longitudinal opening to direct different parts of liquefied material from a liquefied element to different holes 14.
    [0058] While in the modality presented, the ACP comprises four fastening parts, each with a longitudinal opening for a liquefied element to be inserted, which is not necessary. For example, the ACP may comprise a combination of fastening parts of the type described with conventional fasteners such as surgical screws that need to be inserted through the fastening holes. For example, ACP may comprise conventional fasteners for anchoring to stronger and healthier bone tissue and fastening parts for subcortical anchoring of the type described in locations where the bone tissue is weaker and / or less dense.
    [0059] In other variations, it is possible to replace at least some of the fixing parts that are rigidly fixed to the plate part by the tube elements that can be inserted separately, for example, as described in WO 2010/096942 incorporated here by reference .
    [0060] In addition, the total number of fastening parts need not be four, but it can be another suitable number, for example, three, five or six. It is additionally possible that the ACP extends not only through two vertebrae, but through more vertebrae, for example, three vertebrae, whereas the ACP can be anchored in all the vertebrae through which it extends (for example, by two fixation parts for each) or, in special situations (for example, with a vertebra partially removed) only in some of them, for example, the upper and lower vertebrae of a series of three vertebrae.
    [0061] In all embodiments, the plate part and the fixing parts can be made of a metal, for example, titanium or stainless steel. In the alternative modalities, they can also be made of an unabsorbed plastic, such as PEEK. It is also possible to create them from a reabsorbed plastic, such as a PLA. If the plate part and the fastening parts are made of a thermoplastic, the softening temperature should preferably be higher than the softening temperature of the thermoplastic elements that are inserted in the sheath elements of the fastening parts, so that only the thermoplastic elements and not the fixing parts liquefy. Often, a softening temperature difference of 20 C (or more) is sufficient to guarantee this.
    [0062] For implantation, the surgeon can optionally, in a first step, locally remove the cortical bone tissue in places where the fixation parts must be activated into the vertebral bodies. After that, the ACP is inserted; if necessary, it can be hammered to drive the fixation parts fully into the bone tissue until the plate part rests against the cortical bone. Then, if the fastening parts do not comprise a thermoplastic element, that thermoplastic element is introduced into the longitudinal opening from the proximal side of it. An insertion tool with a mechanical vibration generator (such as an ultrasonic transducer) and a sonotrode is used to liquefy at least partially the thermoplastic material of the thermoplastic element at the distal end to drive that material through the holes 14 within the surrounding tissue. The sonotrode, for this purpose, may have a transverse area slightly smaller than the transverse area of the longitudinal opening in order to drive the thermoplastic element more deeply into the cover.
    [0063] While in the embodiment described above, the plate part is shown to be essentially flat and the fastening parts are essentially perpendicular to the plate part, this need not be the case. A main advantage of the approach according to the invention which comprises the fixing parts to be integrally formed with the plate part is that mechanically stable constructions are possible and when implanted they extend only minimally away from the vertebral bodies. Such constructions may comprise non-flat plate parts. A first approach presented schematically is illustrated in Figure 3. The anterior cervical plate is implanted and anchored in two neighboring vertebral bodies 31. An intervertebral disc is illustrated between the intervertebral bodies; as the case may be instead of a natural intervertebral disc, an intercorporeal spacer (cage) can be located to replace the intervertebral disc prior to anchoring the ACP. The parts of thermoplastic material 22 that during the anchoring process come out through the holes 14 into the surrounding fabric are schematically illustrated in Figure 4. As can be the case for any modality, the fixing parts are positioned to be anchored centrally with respect to to the upper-lower geometric axis in the vertebral bodies. Whereas the anterior cervical plaques according to the modalities of the invention can be designed to stabilize different types of vertebrae, i.e., lumbar vertebrae, thoracic vertebrae, and cervical vertebrae, the embodiment of Figure 3 belongs to the vertebrae of the upper thorax. In Figure 3, esophagus 35 is also illustrated schematically. If an anterior cervical plaque is implanted, its configuration and location must ensure that the esophagus is not irritated despite being instead of close to the spine. Figure 4 illustrates, in schematic section through a transverse plane, a possible configuration with the plate being folded, in a central region (around the longitudinal geometric axis of the ACP / in proximity to the sagittal plane), in the direction of the dorsal direction to provide more space for the esophagus 35.
    [0064] The plate part can be comparatively thin and despite having sufficient mechanical stability. Figures 5a to 5d illustrate a configuration in which the friezes 131 varying from the corner regions, in continuity with which the fastening parts are made, towards the center and reduce towards the center are illustrated. Figures 5b, 5c, and 5d illustrate sections along lines B-B, C-C and D-D in Figure 5a, respectively. The characteristics illustrated in Figure 3 (a concave configuration folded towards the ventral side in a longitudinal section (cut along the sagittal plane); a central region being folded towards the dorsal side in the transverse direction; the friezes; and / or the inclined corner parts) can be arbitrarily combined, that is, all of these characteristics can be combined with each other, or subgroups of two or three of these characteristics can be combined in any grouping; in addition, the anterior cervical plate need not be symmetrical, but it can also be asymmetrical (for example, the friezes and / or the inclined corners may be present on one side only, etc.)
    [0065] The shape of the plate part illustrated with respect to Figures 5a to 5d is merely an example. The way in which the plate part differs from a flat configuration can be changed in many ways. For example, it is possible to provide the plate part with protrusions instead of illustrated friezes. In addition, the friezes can be folded to project into the opposite direction and / or can be located elsewhere. Depending on the anatomy surrounding the ACP, the total 3D structure of the plate can be chosen in many different ways.
    [0066] Figure 6 schematically illustrates a configuration in which the fastening parts 124 are not at right angles to the plate part, but at a different angle. Generally, the fastening parts (or at least those fastening parts that are integral with the plate part) are approximately parallel to each other.
    [0067] Figures 7a and 7b illustrate a variation of a fixation part 124. In this variation, the fixation part does not comprise a radial hole, but only a distal hole 19 through which the liquefied material exits into the surrounding tissue. In order to provide configuration stability against the movements of the ACP in the ventral directions, the longitudinal opening comprises a shoulder 128 that cooperates with a proximal widening 22 of the thermoplastic element 21.
    [0068] Figures 8 and 9 illustrate the possibility of providing the fixator with a non-enlarging retention structure within which the bone tissue can grow to ensure long-term anchorage stability.
    [0069] Figure 8 illustrates a distal region of a fixation part, with wings 126 similar to the mode of Figures 1 and 2. The wings are provided with notches 130 (in alternative configurations, the external contour comprises a waveform). These notches form a non-enlarging retention structure that does not cause substantial additional resistance against the insertion of the fixation part of the anterior cervical plate. At the time after implantation, the bone tissue can grow within the retention structures so that the anchorage in the bone tissue has additional stability. The approach of supplying the fastening parts with an external retaining structure can be combined with the use of a resorbed thermoplastic material.
    [0070] Another example of non-flaring retaining structures is illustrated in Figure 9. The fastening part comprises circumferential protrusions 129 serving as retaining structures. Combinations of the wing retaining structures 126 (if present, as shown in Figure 8) and the attachment part body (as shown in Figure 9) are possible. A ditionally or alternatively, micro retention structures can be used, such as a desired surface roughness of the fastening part or a part thereof. A maximum surface roughness of such parts can, for example, be between 1 μm and 100 μm, especially between 1 μm and 50 μm or 20 μm, for example, between 2 μm and 10 μm.
    [0071] The stabilization structure in most of the modalities described so far comprises a distal stabilization part of the radial holes through which the liquefied thermoplastic material exits. Alternative configurations are possible, for example, fastening parts that have an elliptical or otherwise elongated cross section, especially to have a greater extent in the transverse direction than in the upper / lower direction. An example in which this is done for one end is shown in Figure 10. The embodiment of Figure 10 comprises only two fastening parts 24 that have a substantial transverse extension. In contrast to the modalities described so far, the thermoplastic elements 21 are not pin-shaped, but have a shape adapted to the shape of the fastening parts 124. In the embodiment shown, the radial holes 14 are arranged at the distal end of the fastening parts. However, the configuration in Figure 10 can also be implemented with more proximal radial holes, for example, for subcortical anchoring.
    权利要求:
    Claims (14)
    [0001]
    Surgical stabilizer plate (121), comprising a plate portion (122) for stabilizing a human or animal spine being placed ventrally from the spinal column and being affixed to two or more different vertebral bodies, and additionally comprising a plurality of fixation parts (124) adapted to be anchored in different vertebral bodies, at least one of the fixing parts (124) being rigidly connected to the plate part (122) and comprising a sheath element with a longitudinal opening that is accessible from a proximal side and at least one radial hole (14) reaching from the longitudinal opening outwards, the surgical stabilizer plate (121) additionally comprising, by sheath element, a thermoplastic element (21) inserted or insertable in the sheath element and capable to be liquefied by the energy acting on the thermoplastic element (21), in which the hole (14) is positioned so that the liquefied thermoplastic material is p through the hole (14) into the bone tissue of the vertebral body in which the fixation part (124) must be anchored, characterized by the fact that the at least one fixation part (124) comprises a stabilization structure capable of absorbing mechanical loads on the surgical stabilizer plate (121), wherein the stabilizing structure is comprised in addition to a portion of the at least one fixation part (124), said portion of the at least one fixation part (124) forming the element sheathed, and comprising a distal stabilizing part with respect to the radial hole (14), and in which the plate part (122) is non-flat.
    [0002]
    Surgical stabilizer plate (121) according to claim 1, characterized in that a distance between the plate part (122) and the at least one radial hole (14) is adjusted so that the liquefied material is pressed out through the radial hole (14) into the surrounding bone tissue after resolidification provide a subcortical anchorage.
    [0003]
    Surgical stabilizer plate (121) according to claim 1 or 2, characterized in that an axial extension of the stabilization part is at least two thirds of a distance between the plate part (122) and the radial hole (14 ).
    [0004]
    Surgical stabilizing plate (121) according to any one of claims 1 to 3, characterized in that the fixing parts (124) have a non-circular cross section.
    [0005]
    Surgical stabilizing plate (121), according to claim 4, characterized by the fact that a transverse extension of the fixation parts (124) is greater than an extension in an upper-lower direction.
    [0006]
    Surgical stabilizing plate (121) according to claim 4 or 5, characterized in that at least one of the fixing part (124) comprises a wing projection of a fixing body.
    [0007]
    Surgical stabilizer plate (121) according to any one of claims 1 to 6, characterized in that the plate part (122) has a belted shape.
    [0008]
    Surgical stabilizer plate (121) according to any one of claims 1 to 7, characterized in that the plate part (122) comprises at least one of the protrusions and ridges.
    [0009]
    Surgical stabilizer plate (121), according to claim 8, characterized by the fact that the friezes (131) extend from the corner regions of the plate part towards the center.
    [0010]
    Surgical stabilizing plate (121), according to claim 9, characterized by the fact that the friezes (131) reduce towards the center.
    [0011]
    Surgical stabilizer plate (121) according to any one of claims 1 to 10, characterized in that the plate part is curved.
    [0012]
    Surgical stabilizing plate (121), according to claim 11, characterized by the fact that the plate part is curved, and in a cross section, a central region extends towards the dorsal direction.
    [0013]
    Surgical stabilizing plate (121) according to any of claims 11 to 12, characterized in that in a section along the sagittal plane, the plate part (122) is curved towards a ventral side.
    [0014]
    Surgical stabilizing plate (121) according to any one of claims 1 to 13, characterized in that it is an anterior cervical plate.
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    JP2013540509A|2013-11-07|
    JP2017060774A|2017-03-30|
    CN103269650B|2016-10-26|
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    法律状态:
    2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-08-04| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2020-12-01| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-01-26| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 22/09/2011, OBSERVADAS AS CONDICOES LEGAIS. |
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    US39458010P| true| 2010-10-19|2010-10-19|
    US61/394,580|2010-10-19|
    PCT/CH2011/000224|WO2012040863A1|2010-09-30|2011-09-22|Anterior cervical plate|
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