DEVICE FOR FIXING A SUTURE ANCHOR

专利摘要:
DEVICE AND METHOD FOR FIXING A SUTURE ANCHOR AND SUTURE ANCHOR SUITABLE FOR THE DEVICE. The present invention relates to a tool (1) for fixing a suture anchor (2) in a rigid tissue opening with the aid of a material that has thermoplastic properties and energy transmitted to the suture anchor for liquefaction in situ of at least part of the material that has thermoplastic properties, comprises a distal face (10), an axial channel (11) and a substantially tubular shaped interface piece (3) that fits within the axial channel (11) of the tool (1), in which the axial channel (11) and a proximal end of the interface piece (3) are equipped with capture elements (12 and 1239>) that cooperate to capture the interface piece (3) in the axial channel ( 11) when the interface piece (3) is moved in a proximal direction in the axial channel (11). The suture anchor coupled to the distal end of the interface piece (3) and comprises an anchor base (22), through which the suture (4) is threaded in the form of a loop, and a thermoplastic sleeve (23).
公开号:BR112013006697B1
申请号:R112013006697-0
申请日:2011-09-21
公开日:2020-06-23
发明作者:Jörg Mayer；Mario Lehmann；Stephanie Goebel-Mehl；Andreas Wenger
申请人:Sportwelding Gmbh；
IPC主号:

专利说明:

FIELD OF THE INVENTION
[0001] The present invention belongs to the field of medical technology and relates to a device and a method for fixing a suture anchor and thereby a suture in the rigid tissue in particular, for fixation, with the aid of suture , from soft tissue to rigid tissue, where the rigid tissue is in particular, the bone tissue of a human or animal patient. The invention also relates to an anchor applicable to the method according to the invention. BACKGROUND OF THE INVENTION
[0002] WO 2009/109057 (Woodwelding) describes devices and methods for fixing a suture to rigid tissue with the aid of a suture anchor, in which the suture anchor comprises a material that has thermoplastic properties and is anchored in a opening of rigid tissue with the aid of the vibratory energy used for in situ liquefaction of the material that has thermoplastic properties. The liquefied material penetrates the pores or other suitable structures of the rigid tissue through the opening of the rigid tissue, where in its resolidification it constitutes a connection with a positive fit between the rigid tissue and the suture anchor. The devices, as described in the named publication, comprise a source of vibration in a housing, a vibration tool, a guide tube, an anchor, a suture and possibly a traction chuck. The proximal end of the vibration tool is coupled to the vibration source, the proximal end of the guide tube is supported on the housing, the anchor is disposed on the distal end of the vibration tool. The anchor comprises material that has thermoplastic properties in the form of a thermoplastic sleeve, the anchor or the vibration tool that reaches through the sleeve and the glove that is compressed between a part of the base of the anchor and the vibration tool, the guide tube or the drive sleeve. A suture loop is attached to the base part of the anchor, two terminal sections of suture extending through other parts of the anchor and through the vibration tool and guide tube portions from which they exit to possibly be kept straight or tensioned by attaching it to the guide tube or housing.
[0003] For implantation, an opening is arranged in the rigid tissue and the distal end of the device or the suture anchor is respectively inserted in the opening, such that at least part of the thermoplastic glove is located in the opening, in which a section cross section of the opening is slightly wider than the cross section of the thermoplastic sleeve so that the material that has thermoplastic properties is located close to the rigid fabric of the opening wall, but in such a way that, during the introduction of the anchor into the opening , there is no friction between the sleeve and the opening wall. The vibration source is then activated and the material that has thermoplastic properties of the thermoplastic sleeve that is compressed between a vibration element (vibration tool or anchor base that is attached to the vibration tool) and a counter element (the anchor base does not). being attached to the vibration tool, the guide tube or the traction chuck) it is liquefied starting from its proximal face and / or distal face and flows into the rigid tissue, through which the thermoplastic sleeve becomes shorter. To maintain the compressive force on the thermoplastic sleeve while the latter is being shortened, the device elements are moved relative to each other in an axial direction which is preferably carried out by a pretensioned spring arranged together with at least the sleeve thermoplastic and the elements between which the thermoplastic sleeve is compressed into a closed load structure. This measure allows the automatic anchoring of the suture anchor, the surgeon having only to position the device with the distal end of the guide tube on the surface of the rigid tissue and activate the vibration source. However, special measures are necessary to allow the verification and adequacy of the device before the anchoring process, without liquefying the material of the thermoplastic sleeve.
[0004] US publication 2009/131947 (Woodwelding) also describes a method for attaching a suture to rigid tissue with the aid of a suture anchor comprising a thermoplastic material that is liquefied in situ with the aid of vibrating energy. The method described is based on the same principle as the method that was briefly described above, in which the suture is threaded through a distal end portion of the anchor, in which a proximal portion of the anchor end comprises the thermoplastic material, and in which a proximal face of the anchor is secured against a distal face of a vibration tool by tractioning the terminal portions of the suture in a proximal direction.
[0005] Other methods and devices for attaching sutures to rigid tissue with the aid of suture anchors are described in publications US-7678134, US-7695495, US-2006/161159, US-2009/192546, US2009 / 187216 (all of which are Arthrex), US-5733307 (Dinsdale), or US6508830 (Steiner), in which the anchors described above comprise an interference screw to be screwed into a bone opening provided for the purpose or a plug made preferably of bone material and to be snapped into a bone opening provided for the purpose, in which the suture is secured by the screw or plug or by an additional element that is retained in the opening with the aid of the screw or plug.
[0006] The methods of anchoring an item in an opening provided in the rigid tissue, for example, in the bone tissue of a human or animal patient with the aid of a material that has thermoplastic properties which is liquefied in situ and driven to penetrate in the rigid fabric of the opening wall are described in publications US7335205, US-7008226, US-2006/0105295, US-2008/109080, US2009 / 131947, WO-2009/109057, and WO-2009/132472. The description of all these publications and applications is included here by reference. SUMMARY OF THE INVENTION
[0007] Expressed in general terms, the objective of the invention is the creation of another device and method for fixing a suture anchor and thereby a suture in the rigid tissue, in which the suture is fixed in the rigid tissue with the the aid of the suture anchor must be, in particular, suitable for fixing the soft tissue to the rigid tissue, in which the rigid tissue is in particular, the bone tissue of a human or animal patient, and in which one of the steps of the method comprises liquefaction in situ of a material that has thermoplastic properties and the exposure of the liquefied material to contact with the rigid fabric. The suture anchor is attached to a rigid tissue opening by penetrating the liquefied material into the rigid tissue walls of the opening, or it is attached after a rigid tissue opening by the expanding liquefied material (flowing in the radial direction) ) beyond the opening, that is, on an inaccessible side of a layer of rigid fabric, possibly combined with the penetration of the surface of the rigid fabric on this inaccessible side of a layer of rigid fabric. In the re-consolidation of the material that penetrated the rigid fabric, a connection with a positive fit is formed between this rigid fabric and the anchor and / or the material expanded beyond the rigid fabric opening, which constitutes a body that cannot pass through the opening. The improvement obtained by the invention, in comparison to the prior art methods and devices that serve the same purpose, refers, in particular, to the simplicity of the method and the device.
[0008] In particular, it is an object of the invention to create another device and another method for fixing a suture anchor during or after an opening in the rigid tissue of a human or animal patient, the suture anchor and the fixation which are particularly suitable for the suture fixed with the aid of the suture anchor must be slidable in relation to the anchor that is fixed on the rigid tissue. In this sense, the fixation of the suture anchor in the rigid tissue, in particular, under a layer of cortical bone must be carried out with the aid of a material that has thermoplastic properties and that is liquefied in situ to be placed in contact with the tissue. rigid, in particular, to penetrate the natural pores (trabecular structure) of the rigid tissue or within suitable structures or cavities provided in the rigid tissue, to preferably form, during resolidification, a positive fit connection between the anchor and the tissue hard. The device and the method according to the invention must constitute an improvement in relation to the state of the art known, in particular, in relation to the stability and simplicity of the device and simplicity of the entire fixation process which includes preparatory steps. The device and method according to the invention must be suitable, in particular, for minimally invasive surgery, however, they must also be applicable to open surgery.
[0009] The mentioned objectives are obtained by the device and method as defined in the independent claims.
[00010] The device and method according to the invention constitute another advance of the devices and methods as described in WO 2009/109057, the description of which is included in its entirety here by reference. In this sense, the device is improved in relation to the stability against the lateral forces acting on the anchor when it is disposed on a distal end of the tool and this device is simpler because it does not need a guide sleeve. In addition, it can understand means for easy mechanical and possibly visual control of the liquefaction of the material that has thermoplastic properties. In addition, the device according to the invention may comprise a lever system which is operated by the surgeon and which facilitates the handling of the suture, that is, it constitutes means for fixing, tensioning and moving the suture. Device according to the invention is easily operated by the surgeon with one hand, in which he is able to operate the lever system with one finger of this hand. The lever system simplifies not only the implantation process, but also the steps of preparing the device for the implantation process.
[00011] The device according to the invention comprises a tool with a proximal end suitable for coupling to the energy source and a distal end suitable for the suture anchor arrangement, which includes the suture. In addition, the device comprises an interface piece with a substantially tubular shape, which serves to stabilize the anchor at the distal end of the tool, such that it can be safely positioned in relation to the rigid fabric and can be kept in line with the tool during the fixing procedure. The interface piece is designed to be displaceable in an axial channel at the distal end of the tool during the clamping procedure and to be removable from the clamping place together with the tool.
[00012] The device can also comprise the anchor that includes a suture, and possibly the energy source, the anchor being arranged at the distal end of the tool and the energy source being coupled to the proximal end of the tool. The power source or housing can load the lever system mentioned above. The anchor comprises material that has thermoplastic properties in the form of a thermoplastic sleeve which is stuck between a distal tool face and an anchor base and which, in the process of fixation, is at least partially liquefied preferably starting from of its proximal face in contact with the distal tool face, whereby the liquefied material flows in a radial direction to penetrate the rigid tissue surrounding the liquefaction site or a cavity provided in this rigid tissue, or to expand within the soft tissue or a cavity in addition to the hard tissue. To keep the thermoplastic glove in great contact with the distal tool face during the liquefaction process, the anchor base is pulled in relation to the tool in the proximal direction with the aid of the suture, which is performed by the surgeon in an advantageous way with the aid of the lever system mentioned above.
[00013] The interface part is dimensioned to reach the thermoplastic sleeve, a distal end of the interface part being attachable or being coupled to the anchor base and a proximal end that reaches an axial channel of the tool. During the liquefaction process, the thermoplastic sleeve becomes shorter and the anchor base together with the interface piece is moved in relation to the tool in a proximal direction. For the mechanical control of the liquefaction process, the tool may comprise a lock in which the proximal face of the interface piece will touch when the thermoplastic sleeve has reached the desired minimum axial length. For additional visual control, the tool can comprise a lateral recess or a hollow portion adjacent to the lock distally, in which the movement of the recess or hollow portion of the proximal end of the interface piece can be visually controlled, during minimally surgery invasive through an arthroscope or during surgery opened directly by the surgeon. In order to be removable from the clamping place with the tool after the clamping has ended, the interface piece is stuck in the axial channel of the tool as long as possible during the completion of the clamping process, so that it cannot be removed of the channel in a distal direction. The anchor base is preferably connected to the interface piece with the aid of a push or tight connection which holds the two elements together when they are not under any load, which stabilizes the two elements in relation to each other under one compressive load, which is easily disconnected under a small extensible load.
[00014] The suture extends in a loop through a system of channels and / or grooves in the anchor base, the two end sections of the suture projecting from the proximal side of the suture and extending from there through the piece interface and axial channel of the tool from which they preferentially exit through the recess mentioned above. The system of channels and / or grooves is preferably dimensioned in such a way that the suture is easily slidable through it and in such a way that, during implantation, the suture does not come into contact with the rigid tissue of the tissue opening or with the liquefied material. This measure ensures that neither the friction on the rigid tissue nor the thermal influence or mechanical influence of the liquefied or resolidified material of the thermoplastic glove will impair the ability of the suture to slide along the implanted anchor. This means not only that after the suture anchor is anchored, the suture will be slidably attached to the last, but it also means that the suture may well be of the friction and / or heat sensitive type, which consists, for example, in a material that has characteristics similar to the material of the thermoplastic glove.
[00015] For the fixing process, the tool is preferably supported on the rigid fabric. To achieve liquefaction under a layer of cortical bone or on an inaccessible side of a bone plate, the tool comprises the step at a distance from the distal tool face adapted to the thickness of the cortical bone layer or bone plate . In this sense, the tool portion on the distal side of the step has a smaller cross section than the cross section of the opening, and a portion of the tool on the proximal side of the step has a wider cross section than the cross section of the opening. , in such a way that the step limits the introduction of the distal end of the device into the opening of the rigid tissue through contact with the surface of the rigid tissue, with the interface between the distal tool face and the proximal face of the thermoplastic glove and with this is the liquefaction site and is located just below the cortical bone layer or on the other side (not accessible) of the bone plate. During the liquefaction process, the tool is kept in the same position.
[00016] The energy source is preferably a source of vibration, in particular, a source of ultrasonic vibration (for example, an ezoelectric pivibration generator that possibly comprises an amplifier to which the tool is attached) and the tool is suitable for transmission of vibration from its proximal end to its distal face, preferably in such a way that the distal face vibrates with a maximum longitudinal amplitude. For in situ liquefaction, the proximal face of the thermoplastic sleeve is held against the vibration of the distal tool face, thereby creating frictional heat at the interface. It is also possible to activate the tool to vibrate in a radial or rotational direction.
[00017] Alternatively, the energy source can be a laser, preferably a laser that emits light in the visible or infrared frequency range and the tool is equipped to transmit this light to its distal end, preferably via fiber glass. For in situ liquefaction the laser light is absorbed close to the distal tool face or in the thermoplastic glove attached to the distal tool face, where in the latter case, the material of the thermoplastic glove may contain particles or substances that perform such absorption. In addition, the energy source may be an electrical energy source that, for example, heats an electrical resistor in a distal portion of the tool or that causes eddy currents and thereby thermal energy near the distal tool face or in the thermoplastic sleeve. .
[00018] Adequate in situ liquefaction of a material that has thermoplastic properties with the aid of vibration energy combined with an acceptable thermal loading of the fabric and the production of suitable mechanical properties of the positive fitting connection are possible through the use of materials with thermoplastic properties having an initial modulus of elasticity of at least 0.5 GPa and a melting temperature of up to about 350 ° C in combination with vibration frequencies preferably in the range of 2 to 200 kHz (preferably 15 to 40 kHz) kHz, or more preferably between 20 and 30 kHz). The modulus of elasticity of at least 0.5 GPa is particularly necessary if the material that has thermoplastic properties needs to transmit vibration or mechanical forces without loss of mechanical stiffness. If the material that has thermoplastic properties does not need to transmit vibration, but has to be liquefied when it is in direct contact with the vibration tool, or if the material that has thermoplastic properties needs to transmit vibration or mechanical forces, but is supported and guided by parts of the device from other materials, the material having thermoplastic properties may have a considerably less modulus of elasticity.
[00019] Materials that have thermoplastic properties suitable for the thermoplastic sleeve of the device and method according to the invention are thermoplastic polymers, for example, resorbable or degradable polymers such as polymers based on lactic acid and / or glycolic acid (PLA , PLLA, PGA, PLGA etc.) or polyhydroxy alkanoates (PHA), polycaprolactone (PCL), polysaccharides, polydioxanes (PD) corresponding polyanides, polypeptides or copolymers or composite materials containing the mentioned polymers as one of their components; or non-resorbable or non-degradable polymers such as polyolefins (for example, polyethylene), polyacrylates, polymethacrylates, polycarbonates, polyamides, polyester, polyurethanes, polysulfones, polyarylketones, polyimides, liquid crystal polymers of polyphenylsulphates, polymers, polyacetals in particular, halogenated polyolefins, polyphenylsulfides, polysulfones, polyethers, equivalent copolymers or composite materials containing the mentioned polymers as one of their components.
[00020] The specific modalities of degradable materials are Polylactides such as LR706 PLDLLA 70/30, R208 PLDLA 50/50, L210S, and PLLA 100% L, all from Böhringer. A list of suitable degradable polymer 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 more information on PGA and PLA see pages 202 f, on PCL see page 207, on PHB / PHV copolymers see page 206; on polydioxanone PDS page 209. The discussion of other bioresorbable material can be found, for example, in CA Bailey et al., J Hand Surg [Br] 2006 Apr, 31 (2): 208-12.
[00021] The specific modalities of non-degradable materials are Polyetherketone (PEEK Optima, Grades 450 and 150, Invibio Ltd), Polyetherimide, Polyamide 12, Polyamide 11, Polyamide 6, Polyamide 66, Po-licarbonate, Polymethylmethacrylate, Polyoxymethylene, or polycarbonatourethane ( for example, DSM Bionate, in particular, types 65D and 75D). A table of the overview of polymers and their applications is listed in Wintermantel, page 150; specific examples can be found at Wintermantel page 161 f. (PE, Hostalen Gur 812, Hõchst AG), pages 164 f. (PET) 169f. (PA, namely, PA 6 and PA 66), 171 f. (PTFE), 173 f. (PMA), 180 (PUR, see table), 186 f. (PEEK), 189 f. (PSU), 191 f (POM Poliacetal, trade names Delrin, Tenac, are also used in Protec endoprostheses).
[00022] The material that has thermoplastic properties can also contain external phases or compounds that serve additional functions. In particular, the thermoplastic material can be reinforced by mixed fibers or fluff (for example, from ceramics or calcium phosphate glasses) and they represent a composite material. The material that has thermoplastic properties may also contain components that expand or dissolve (create pores) in situ (for example, polyesters, polysaccharides, hydrogels, sodium phosphates), compounds that make the implant opaque and thereby visible on X-rays, or compounds to be released in situ and which have a therapeutic effect, for example, promoting healing and regeneration (eg growth factors, antibiotics, inflammation inhibitors or buffers such as sodium phosphate or calcium carbonate against adverse effects of acidic decomposition). If the thermoplastic material is resorbent, the release of such compounds is delayed. If the device has to be anchored without the aid of vibration energy but with the aid of electromagnetic radiation, the material that can be liquefied and that has thermoplastic properties can contain locally compounds (particulate or molecular) which are capable of absorbing such radiation from a specific frequency range (in particular, from the visible or infrared frequency range), for example, calcium phosphates, calcium carbonates, sodium phosphates, titanium oxide, mica, saturated fatty acids, polysaccharides, glucose or mixtures of the same.
[00023] The fillers used may include degradable fillers, osseostimulants to be used in degradable polymers, which includes: P-Tricalciophosphate (TCP), Hydroxyapatite (HA, <90% crystallinity); or mixtures of TCP, HA, DHCP, Bio-glasses (see Wintermantel). Bone integration simulation fillers that are only partially or extremely degradable for non-degradable polymers include: Bio-glass, Hydroxyapatite (> 90% crystallinity), HAPEX®®, see SM Rea et al., J Mater Sci Mater Med. 2004 Sep; 15 (9): 997-1005; for hydroxyapatite see also L. Fang et al., Biomaterials 2006 Jul; 27 (20): 3701-7, M. Huang et al., J Mater Sci Mater Med 2003 Jul; 14 (7): 655-60, and W. Bonfield and E. Taner, Materials World 1997 Jan; at the. 1: 18-20. The modalities of bioactive fillers and their discussion can, for example, be found in X. Huang and X. Miao, J Biomater Abr. 2007 Abr; 21 (4): 351-74), JA Juhasz and other Biomaterials, 2004 Mar; 25 (6): 949-55. The types of particulate filling include: coarse type: 5-20um (contents, preferably 10-25% by volume), submeron (nano-fillings as from precipitation, preferably plate-type aspect ratio> 10, 10-50 nm, contents of 0.5 to 5% by volume). Experiments show that liquefaction with the aid of ultrasonic vibration energy allows the filling of the thermoplastic polymer to a relatively high degree without impairing the ability of the liquefied material to penetrate structures such as, for example, the viable spongy bone trabecular structure.
[00024] Anchor portions other than the thermoplastic sleeve can consist of any suitable material (for example, polymer, metal, ceramic, glass) which material can be bio-absorbent or non-bio-absorbent and can be liquefied or may not be liquefied. Such non-bio-absorbent or non-biodegradable materials may comprise surfaces equipped for more osseointegration (for example, per se known surface structures or coatings) where in contact with bone tissue, in particular, if the material of the thermoplastic glove is bio-absorbent or biodegradable and, therefore, the anchoring function needs to be gradually controlled by osseointegration. Good results were obtained, for example, with anchor bases made of polylactic acid (PLA) filled with Hydroxyapatite or chalcophosphates, in particular, PLLA filled with 60% tricalciophosphate or PDLLA 70% / 30% (70% L and 30% D / L) filled with 30% biphasic calciophosphate, combined with PLDLLA 70% / 30% thermoplastic gloves (70% L and 30% D / L), as available through Böhringer as LR706. PDLLA 70% / 30% filled with 30% biphasic calciophosphate and similar materials have proven that they are also suitable for the thermoplastic glove and, therefore, suitable for the manufacture of bioresorbents, one-piece anchors that are made of only one material.
[00025] Since the tool can be designed to be very thin and with an axial length of 200m or even longer, the device and method according to the invention are in particular suitable for minimally invasive surgery, but they are also applicable to open surgery. If the tool is a vibrating tool, it preferably has a length that corresponds to half the wavelength of the vibration in the tool material (or a multiple thereof). This half of the vibration wavelength is, for example, in the degree of titanium and at a vibration frequency of 20 kHz 126. 5 m.
[00026] The device and method according to the invention to the extent described above are applicable to all surgical procedures on a human or animal patient, in that surgical procedure a suture needs to be fixed to the rigid tissue, in particular, fixed to be at least primarily slidable in relation to the implanted anchor, and in particular to bone tissue with a layer of cortical bone in which anchor fixation is preferably obtained under the layer of cortical bone (the so-called subcortical fixation) in the bone spongy located underneath the cortical bone layer, on the inner side of the cortical bone layer, or in a cavity or soft tissue adjacent to the cortical bone layer on its inner side. Likewise, the device and method according to the invention are applicable for attaching a suture to a replacement material that has characteristics comparable to the characteristics of the rigid tissue, or to the part of the rigid tissue, part of the replacement material, or the another implant (eg, endoprosthesis) in which the implant needs to be adequately equipped, for example, with openings with sub-cuts. An example of such an application is the fixation of a soft tissue tip to a bone, for example, the fixation of a rotator cut to underlie the bone tissue (or a corresponding endoprosthesis), the repair of the Achilles tendon, or the fixation from another end of ligament or tendon in bone tissue using the so-called double-row procedure. For this procedure, the sutures are slidably fixed to the bone by a row of medial anchors, they are traversed in the soft tissue, tensioned and cross, the anchors not slidably fixed (locked) with the aid of a side row, this second row extending substantially parallel to the row of medial anchors.
[00027] During the use of the device and the method discussed above according to the invention for the sliding fixation of the sutures, that is, for the anchoring of the medial anchors, with the aid of the material that has thermoplastic properties and preferably with the vibration energy, it is advantageous to use a similar technique for non-slip fixation or suture locking, that is, also for anchoring side anchors.
[00028] As described below, it is also possible to use the device and method according to the invention not only for the lateral fixation of a suture in relation to a rigid tissue, but also for such non-slip fixation or locking of the suture in relative to the rigid tissue respectively. BRIEF DESCRIPTION OF THE FIGURES
[00029] The device and method according to the invention are described in more detail in connection with the attached Figures, in which:
Figure 1 illustrates an exemplary embodiment of the device according to the invention by illustrating a distal portion of the device before the anchoring procedure and after the anchoring procedure, this distal portion of the device comprising a distal portion of the tool, the workpiece interface, the suture anchor and the suture extending through the anchor; Figure 2 shows the suture anchor as shown in Figure 1 which is attached to the opening of rigid tissue; Figure 3 shows another exemplary embodiment of the distal portion of the tool and the interface part of a device according to the invention; figures 4 and 5 further illustrate an exemplary embodiment of the device according to the invention by illustrating an exemplary embodiment of the proximal portion of the device comprising the proximal portion of the tool, the energy source with the housing and fixed in the housing, the lever system for securing and tensioning the suture and for moving the anchor base with the aid of the suture; Figure 6 illustrates another exemplary embodiment of the method according to the invention and of the anchor that is fixed with the aid of the metos; Figure 7 illustrates four successive stages of the known double-row procedure per se using the example of a rotator cut repair; Figure 8 shows the anchor fixed as shown in Figure 2 and still equipped with a locking plug to lock the suture in relation to the anchor; Figure 9 illustrates another exemplary method of the method according to the invention in which the suture is locked in relation to the anchor with the aid of a locking plug; Figure 10 shows the anchor fixed as shown in Figure 2 and equipped with a fixing sleeve that prevents damage at the edge of the opening of the rigid tissue opening by the suture or the suture by this edge; Figure 11 shows a preferred embodiment of a suture anchor applicable to the device and method according to the invention; Figures 12 to 15 show the proximal end portion of a vibration tool which is, for example, applicable to the device and method according to the invention. DESCRIPTION OF THE PREFERRED EMBODIMENTS
[00030] Figure 1 shows a distal portion of an exemplary embodiment of the device according to the invention and illustrates in section the distal end of a tool 1, suture anchor 2 and interface piece 3. Suture 4 is also illustrated (shown as a dotted line), which extends in a loop through anchor 2, the suture end sections extending through the interface piece 3 and through the tool parts 1. The distal device portion is shown positioned in relation to the opening of rigid tissue before liquefaction and the anchoring process (left side of Figure 1) and after this process (right side of Figure 1), in which the opening of rigid tissue is, for example, an opening in bone tissue and arrives from a bony surface 6 through a layer of cortical bone 7 within the spongy bone tissue 8.
[00031] Tool 1 comprises at its distal end a distal tool face, axially extending from the distal tool face an axial channel 11. The axial channel 11 comprises a first catch element 12, for example, a protrusion in wedge-shaped and in the proximal direction that follows the first capture element 12, a lock 13 which terminates the axial channel 11 or closes it at least partially. The lock 13 consists of the housing illustrated by the proximal wall of a lateral recess 14, the recess opening the axial channel 11 laterally for visual inspection. The portion of the tool adjacent to the side recess 14 in the proximal direction comprises a groove aligned with the side recess 14 for the accommodation of suture 4. Tool 1 preferably still comprises an external elevation 16, which separates a distal end portion 17 from the tool 1 which has a smaller cross section of a proximally adjacent portion which has a wider cross section. As shown in Figure 1, it is sufficient that the elevation 16 extends only around part of the circumference of the tool. However, it can also extend around the entire circumference of the tool.
[00032] Suture anchor 2 comprises anchor base 22 and thermoplastic sleeve 23, in which anchor base 22 and thermoplastic sleeve 23 can be separate items or in which anchor base 22 and thermoplastic sleeve 23 can constitute a piece. The anchor base 22 comprises a system of channels and / or grooves 25 through which suture 4 extends through a preferably slidable loop that enters and exits through the proximal face of the anchor base 22. As shown in Figure 1, the system of the channels and / or grooves comprises, for example, a first transverse channel 30 that extends substantially perpendicular to the geometric axis of the anchor base, and in the region where both openings of these recesses 31 or grooves of the first channel 30, as well as a second axial channel 32 extending to the proximal face of the anchor base 22 and which is connected to the recesses 31 or grooves through third angled channels 33.
[00033] For accommodating more than one suture 4, the system of channels and / or grooves 25 can comprise more than one first transverse channel 30 and these channels can be arranged axially being spaced from one another, parallel to each other others or angled each other.
[00034] The interface piece 3 has a substantially tubular shape and is designed to extend loosely through the thermoplastic sleeve 23. The interface piece is coupled (or is attachable) by an distal end to the anchor base 22 and passes from the face of the proximal glove when the face of the proximal glove rests on the proximal face of the anchor base 22. The coupling of the anchor base 22 and the interface piece 3 is carried out, for example, as illustrated between a protrusion shaped anchor base tube into which a distal end portion of interface piece 3 is, for example, snap-fit. Instead of such a snap-fit coupling, any per se known clamping connection is applicable to which, for example, the distal end of the interface piece 3 comprises a ring-shaped protrusion and a tube-shaped protrusion. the anchor base comprises a ring-shaped projection adapted for the projection. At its proximal end, the interface piece 3 comprises a second capture element 12 ', for example, a depression, adapted for the first capture element 12 in the axial channel 11 of the tool 1 and which cooperates with this first capture element 12 in a manner as described below.
[00035] The suture anchor 2 is arranged at the distal end of the tool 1 with the proximal end of the interface piece 3 extending into the axial channel 11 of the tool 1 and the suture 4 extending from the proximal face of the base anchor 22 through the interface part 3 inside the recess 14 of the tool 1 and from there, into the groove 15. The thermoplastic sleeve 23 is held between the distal face 10 of the tool 1 and the anchor base 22 by the end sections or by suture 4 that is attached to a proximal end of the tool (see, for example, Figure 4). The axial lengths of the interface part 3, the thermoplastic sleeve 23 and the section tool adjacent to the recess 14 in a distal direction are adapted to each other in such a way that the proximal face of the interface part 3 is almost visible in the recess 14, when the thermoplastic sleeve 23 has maximum initial length. The lock 13 is separated from the mentioned position of the proximal face of the interface piece 3 by the length of the thermoplastic sleeve 23 which must be liquefied. The capture elements 12 and 12 'are arranged in such a way that they capture each other before the proximal face of the interface piece 3 touches the lock 13, the collaborating capture elements limiting the distal movement of the interface piece 3 in relation to the tool in such a way that the interface piece cannot be removed from channel 11, however, possibly allowing for another proximal movement.
[00036] In the case of using vibrational energy for the liquefaction process, it is advantageous to equip the distal face 10 of tool 1 (or the proximal face of the thermoplastic sleeve 23) with energy drivers, for example, with a border that limits contact the thermoplastic sleeve to a line, and / or to rigidly fix the distal face of the thermoplastic sleeve 23 to the anchor base 22, which is easily possible if the anchor base 22 is made of a thermoplastic material, for example, of PEEK to which the thermoplastic sleeve 23 can be welded. It is also possible to produce the anchor base and the thermoplastic sleeve as a single piece consisting only of the material that has thermoplastic properties (see also Figure 11), for example, of a polylactide polymer, for example, PDLLA, in a preferred way PDLLA 70% / 30% filled with up to 30% biphasic calcium phosphate. All the mentioned measures help to guarantee the limitation of the liquefaction of the thermoplastic glove 23 on its proximal face. On an anchor base made of a polymer that is prone to dripping, it may be advantageous to reinforce the area more loaded by the tension of the suture, for example, by covering the transversal channel of the suture 30 with a tube made of a more resistant material such as, for example, a polylactide with higher crystallinity or PEEK, or by positioning the portion of such material proximal to the transverse channel of the suture 30.
[00037] As it is more convenient to provide the opening of rigid fabric 5 for anchoring the suture anchor 2 by means of drilling, the anchor and at least the distal end portion 16 of the tool, which must be positioned in the opening 5, advantageously have a circular cross section. The same applies to the anchor base 22, the interface part 3 and the axial channel, as well as the thermoplastic sleeve 23 and the axial channel 11 of tool 1. However, this is not a condition for the invention, according to which any of the items mentioned may have a non-circular cross section. The only condition in relation to the cross sections is the condition that the thermoplastic sleeve 23 must fit within the opening 5 so that a sufficient part of the material is liquefied and is located near the wall of the opening 5. The cross section of the portion distal end 17 of tool 1 and the cross section of the anchor base 22 are preferably the same as the cross section of the thermoplastic sleeve 23 or they are slightly smaller than the last.
[00038] For fixing the suture anchor 2 in the opening of rigid tissue and thereby fixing the suture 4 in relation to the surface of the rigid tissue 6, the device according to the invention is positioned in relation to the bone opening 5 as illustrated on the left side of Figure 1. The power source is attached to the proximal end of the tool 1 (not shown), the interface piece 3 and the anchor 2 are arranged at the distal end of the tool with suture 4 that extends through the base of anchor 22, the interface piece 3, the axial channel 11 of the tool 1 and the recess 14 is attached even more proximally to be at least straightened or slightly tensioned, such that the thermoplastic sleeve 23 is trapped between the proximal face 10 of the tool 1 and the anchor base 22, and the tool 1 is positioned in such a way that the elevation 16 touches the surface of the bone 6. To start the liquefaction of the thermoplastic sleeve 23, the energy source is activated and possibly the tension of the s uture is increased. The liquefied material flows radially away from the anchor 2 and the tool 1, and the thermoplastic sleeve 23 becomes shorter and is kept in contact with the distal face 10 of the tool 1 by pulling the suture 4 in a proximal direction and thereby pulling the base anchor 22 closer to the distal tool face 10, while the elevation 16 continues in contact with the bone surface 6.
[00039] The principle of the anchoring process is described (for different applications), for example, in publication US-2009/131947.
[00040] During operation with a vibration tool and with a friction and / or heat sensitive suture, it is particularly important not to tension the suture during activation of the energy source, but only when the proximal face of the thermoplastic glove is at less heated so that it cannot transmit vibration even more distally or at least not completely. If the suture is tensioned at the moment of the start of the vibration, it can happen that the vibrations are transmitted through the thermoplastic sleeve inside the anchor base which vibrates in relation to the suture. This can damage a sensitive suture before liquefaction of the thermoplastic glove begins. Other measures to prevent the transmission of vibration to the anchor base are the energy drivers at the interface between the tool 1 and the thermoplastic sleeve as described above and / or the beginning of the vibration with a lower starting amplitude and being increased after the beginning of the interval in which the proximal end of the thermoplastic sleeve is heated.
[00041] With the liquefaction process advancing, the thermoplastic sleeve 23 getting shorter and the anchor base 22 being pulled in a proximal direction, the interface piece 3 advances through the axial channel 11 of the recess 14 respectively, until the elements of capture 12 and 12 'reach the capture interaction with each other and the proximal face of the interface piece touches the lock 13, which means the end of the liquefaction process as shown on the right side of Figure 1. The advance of the proximal end of the interface piece 3 and with this the liquefaction process can be visually controlled in the recess 14.
[00042] At the end of the liquefaction process, the thermoplastic glove 23 has a minimum axial length and the liquefied and resolidified material 40 of the thermoplastic glove 23 extends radially into the spongy bone 8 and / or anchors the suture anchor 2 so firmly on the inside of the cortical bone layer 7. In addition, the interface piece 3 is attached to the axial channel 11 of the tool 1, which means that during the removal of tool 1 from within the anchored suture anchor, the interface 3 is removed along with tool 1.
[00043] To make sure that suture 4 is not compressed between the proximal end of the interface piece 3 and the lock 13, when the proximal face of the interface piece touches the lock 13, it is advantageous to project this proximal face and / or the lock 13 that tilts in such a way that the contact of the interface piece 3 with the lock occurs only at the bottom of the recess 14, while suture 4 is removed from this bottom, that is, towards the opening of the recess 14. A the mentioned shape of the proximal face of the interface piece 3 also results in an easier resilience of the contact portion of the proximal face of the interface piece 3 which can make use of the model of the second capture element 12 '.
[00044] After completion of the liquefaction process, suture 4 is released from tensioning and released, and tool 1 along with interface piece 3 is removed from the opening 5 in which suture anchor 2 is now safely anchored, and the suture is slidably attached to the bone tissue.
[00045] Figure 2 shows the result of the method as illustrated in Figure 1, that is, of suture 4 that is attached to the rigid tissue with the aid of suture anchor 2 being anchored in the rigid tissue opening 5 by the resolidified material 40 located in the rigid tissue or the bone tissue that surrounds the opening, in particular, in the spongy bone tissue 8 just below the cortical bone layer 7 (subcortical fixation), the resolidified material 40 being connected to the rest of the thermoplastic glove 23. Obviously the The fixation process according to the invention is not dependent on the quality of the cancellous bone 8, which may even be completely absent. In the latter case, the liquefied material may or may not penetrate the inner surface of the cortical bone layer and may be trapped in the opening of rigid tissue mainly because it is formed after the resolidification of a body which can no longer pass through the opening . This means that the fixation according to the invention is suitable not only for subcortical fixation on spongy bone with reduced mechanical stability, but also in the absence of spongy bone, for example, in the medullary cavity of long bones or on an inaccessible side of a bone plate.
[00046] Figure 3 shows an alternative embodiment of the capture mechanism and the locking mechanism between the tool 1 and the interface part 3 of a device according to the invention. The tool again comprises an axial channel 11 which extends at least through a distal portion of the tool and into which the substantially tubular interface piece 3 extends, and it comprises a recess 14 in which the proximal end of the interface piece 3 lies moves in the proximal direction during the liquefaction process. The first capture element 12 consists of the tool face on the distal side of the recess 14, and the second capture element 12 'is arranged on the proximal protuberance of the interface piece 3. The two capture elements hold the interface piece 3 stuck in the axial channel 11 of tool 1 even when the thermoplastic sleeve still has its original (maximum) length. This means that the interface piece which is removed from the tool to attach to the thermoplastic sleeve and the anchor base is already attached to the axial channel of the tool 11 during the introduction of the proximal end of the interface piece into the axial channel 10 to prepare the device for the fixing procedure. During the liquefaction of the thermoplastic glove material, the second capture element 12 'is distanced in a proximal direction from the first capture element 12 and during the removal of the tool 1 and the interface piece 3 from within the attachment location, the interface piece 3 is moved to its most distal position, in which the two capture elements are in contact with each other.
[00047] The lock 13 of the tool according to Figure 3 is arranged as the elevation in the recess 14 and interacts with the portion of the proximal face of the interface piece 3 which portion is approximately opposite the protuberance with the second capture element 12 '. It is completely possible to dispense with the provision of a lock 13 for the interface piece 3. In such a case, the proximal movement of the interface piece 3 and the anchor base will finally be finished, when the thermoplastic sleeve 23 is completely liquefied and the base of anchor touching the distal tool face. It is also possible to limit the liquefaction process by tensioning the suture, which can be done, for example, with the aid of the lever system which will be discussed together with Figure 4.
[00048] The method and the device according to the invention are suitable, for example, to establish the medial anchors in the procedure per se known with double row, which is described below together with Figure 7 and which is used , for example, for rotator cut repairs or Achilles tendon repairs. For this application, the suture must be kept slid in relation to the anchor. Other exemplary applications of the method and device according to the invention are, for example, related to the shoulder joint of a human being: Bankart's repair or repair of SLAP injuries (anterior and posterior upper labral injury), in relation to the hand of a human being: the repair of UCL (ulnar collateral ligament), the repair SL (scalesfolunar ligament), the repair of collateral ligaments, the fixation of the flexor tendon, or the capsular fixation of the metacarpophalangeal junction, and in relation to the foot of a human being: repair of the Bromstrom ligament, treatment of hallux valgus with me-dial capsulorrhaphy, or perineal retinacular repair.
[00049] The distal end of the device according to the invention, which is shown in Figures 1 to 3 and the method of fixing carried out with the aid of such a device can be varied, for example, as follows without escaping of the basic idea of the invention:
• Instead of the illustrated capture elements 12 and 12 ', any per se known pair of capture elements can be used, in which it is advantageous to design the capture elements in such a way that, at least during the fixation process, the friction between tool 1 and interface part 3 is kept as low as possible and / or only occurs during the last part of the advance of interface part 3 in the axial channel 11 of tool 1. • Instead of the side recess 14, the tool 1 can comprise a hollow portion that allows visual inspection of the movement of the proximal end of the interface piece 3 in the axial channel 11 of the tool 1 and the suture 4 extends out of the tool through a separate opening or through a slot extending from the distal tool face at least to the lock 13. • The tool does not include any means of visual inspection. • The recess 14 is narrow, but it extends exactly on the distal tool face, the interface part 3 comprising for the visual control of the fixing process a frame that extends into the recess and possibly protrudes from the recess and which is visible from the outside of tool 1. • The axial position of the lock 13 is selectable by projecting the lock as a separate lock element, which can be fixed in the recess 14 in various axial positions, or as the selection of separate lock elements of varying axial lengths which can be fixed in recess 14. • Instead of the system of channels and / or grooves which maintain suture 4 in a distal region of the anchor base 22, the anchor base comprises an orifice that projects from its proximal face or other proximal means suitable for maintain suture 4 in a slidable manner. • Suture 4 is attached to the anchor base 22 in a non-slip mode, for example, with the aid of a suture knot or retainer that is retained in a distal recess that has a wider cross section than a proximally adjacent channel in which the suture extends in the proximal direction, or through an end or suture loop that is molded into the anchor base. • Tool 1 does not comprise the elevation 16 limiting the axial length of the distal portion of the tool 17 which has a cross section adapted to fit within the rigid fabric opening 5 or the elevation 16 has another proximal position. This means that the distal end of the tool can be inserted into the opening of rigid tissue at a depth that can be chosen by the surgeon, or the distal end of the tool can be inserted into the opening of rigid tissue to reach the underside of this opening when the process fixing is started. During the fixing process, the distal end of the tool can then be moved further and further into the rigid fabric opening while the thermoplastic sleeve 23 is made shorter as a result of liquefaction, the anchor base 22 remaining positioned against the underside of the opening of rigid fabric 5.
[00050] Unlike what was described above in conjunction with Figure 1, in such a case, during the liquefaction step, it is not the tensioned suture that holds the thermoplastic glove 23 against the vibration tool and it is not the bone surface 6 that supports the tool, but both functions are performed by the bottom face of the opening of rigid fabric. This means that the bone tissue of this lower face needs to have a corresponding mechanical resistance while the necessary mechanical resistance of the suture needs to be adapted solely for the tissue fixation function of this suture.
• The anchor base 22 is adapted, for example, having a distal end tapered or sharpened so that it can be forced at least into the spongy bone without the need to provide an opening in that direction, or to provide such an opening in advance only through the cortical bone. The act of forcing the anchor base 22 into the bone tissue is performed by positioning the anchor base 22 disposed at the distal end of the tool as shown in Figure 1 and applying a force corresponding to the tool 1, the force being transmitted to the anchor base 22 through the thermoplastic sleeve 23. The liquefaction process is initiated by the activation of the energy source (for example, by the vibration source), only when the anchor base 22 has reached the desired depth in the bone tissue. If the act of forcing the anchor base 22 into the bone tissue has to be supported with vibrational energy, the transmission of the pressure force and the vibration from the tool 1 to the anchor base 22 through the thermoplastic sleeve 23 must be prevented to prevent unwanted liquefaction of the thermoplastic sleeve 23 during the pressure step. This can be done by transmitting force and vibration to the anchor base through the interface piece 3 and ensuring that the thermoplastic sleeve 23 rests only loosely between the distal tool face and the anchor base, for example, through the introduction into the recess 14 of a block element which prevents the proximal movement of the interface piece and is capable of transmitting vibration and force from the tool1 to the interface piece. The block element must be removed for the anchoring step. • Anchor base 22 is equipped to be forced into rigid tissue (at least spongy bone tissue) without providing an opening in advance, for example, comprising a distal tapered or otherwise sharpened end and it is forced inward from rigid fabric, for example, aided by ultrasonic vibration, in which to transmit the necessary traction force and vibration to the anchor base 22, the interface piece 3 or another suitable traction tool is used. The thermoplastic sleeve may or may not be attached to the anchor base. When the anchor base has reached the desired depth and, if applicable, after the removal of the traction tool and the assembly of the interface piece 3 on the anchor base 22, and, if applicable, after the assembly of the thermoplastic sleeve 23, the distal end of tool 1 is positioned on the proximal face of the thermoplastic sleeve and the step fixation is performed as described above in conjunction with Figure 1. Instead of forcing the anchor base into the rigid fabric, it is also possible to screw it inside the rigid fabric, on which the interface piece 3 or any other suitable tool can be used to transmit the rotation to the screw-shaped anchor base.
[00051] Figure 4 shows a proximal end portion of an exemplary embodiment of the device that has a distal end as, for example, described above in conjunction with Figures 1 to 3. This proximal end portion is shown in axial section and it comprises the proximal end of the tool 1 which is coupled to the energy source 50 (preferably the ultrasonic vibration generator) disposed in a housing 51, and the two end sections of suture 4 (dotted line). The proximal portion of the end of the device further comprises a lever system 52 which serves as a means to secure and straighten and / or tension the suture 4 and to move the anchor base in a proximal direction in relation to the tool 1 with the aid of the suture 4 that extends through the anchor base (as shown in Figure 1). The lever system 52 is preferably arranged on the housing 51 of the power source 50, but they can also possibly be arranged on the energy source or on the proximal portion of the tool 1. The lever system 52 is designed to be operated by the surgeon.
[00052] In Figure 4 the proximal portion of the device and in particular, the lever system 52 mentioned is illustrated in the three configurations (a), (b) and (c) within which it is placed in succession for an anchoring process . Configuration (a) serves to introduce the end sections of suture 4 into the lever system. In configuration (b), the end sections of the suture are secured by being compressed or locked (by folding around at least a small radius) in the lever system and in configuration (c) the terminal end portions of suture 4 are moved to away in the radial direction and in the proximal direction from tool 1 and housing 51, thereby straightening or tensioning the suture and moving the anchor base (see Figure 1) in relation to the tool once the liquefaction of the thermoplastic glove has started .
[00053] The exemplary embodiment of the lever system 52 as shown in Figure 4 comprises a compression arm 53 and a tensioning arm 54, the compression arm 53 being arranged on the housing 51 in a rotating manner, the tensioning arm 54 being hingedly connected to the free end of the compression arm 53, and the tensioning arm 54 being longer than the compression arm 53 and advantageously being equipped with a terminal section suitable for activating the system manually (not shown). Each of the arms 53 and 54 of the lever system 52 comprises means for securing the suture between the two arms, for example, a pair of compression clamps 55 arranged to compress the suture end sections together when the arms 53 and 54 are rotated relative to each other to extend away from their hinged connection and in substantially the same direction. The arms are also equipped to be locked together (for example, clamping connection) in this clamping position, in which the connector function can be integrated into the compression clamps 55.
[00054] Figure 4 also shows the groove 15 which has already been discussed together with Figure 1 and which preferably reaches the proximal end of the tool and serves to accommodate suture 4, in which the groove 15 and the system lever 52 are aligned with each other. Figure 4 further shows a suture guide 56 disposed between the groove 15 and the lever system 52.
[00055] The fixation of the end sections of suture 4 in the lever system, the straightening or tensioning of suture 4 and the displacement of the anchor base with the aid of the suture are obtained as follows: to thread the end sections of suture 4 through of the lever system 52, the two arms are placed in a substantially extended outward position, advantageously extended in a distal direction (configuration (a)). The end sections of suture 4 extending along the groove 15, or if no groove has been provided, right along the tool 1 towards the proximal end of the tool, and the end sections are threaded through the suture guide 56 and one orifice 57 arriving through one of the arms 53 and 54 on the other (outer) side of the arms, which, in this arm configuration, faces tool 1. The suture ends are then threaded through the other hole 58 on this side outer of the tensioning arm 54 to extend in, guided by the two holes 57 and 58, in addition to the compression clamps 55 of the tensioning arm 54. The end sections of suture 4 are then attached to the free end of the tensioning arm 54 to extend in a stretched way, but not too tensioned along the described path (arrow T, configuration (a)). The tensioning arm 54 is then rotated against the compression arm 53 while the end sections of suture 4 are still attached to the free end of the tensioning arm 54 until suture 4 is compressed between the compression clips 55 and the arms 53 and 54 are locked in relation to each other in the compression position (configuration (b)). In this configuration, the device is checked and possibly adjusted by briefly activating the power source. After such verification and possible adjustment, the device is ready for implantation of the suture anchor.
[00056] During such implantation, suture 4 is tensioned by pulling the free end of the tensioning arm 54 against the housing 51, thereby moving its other end, to which the suture end sections are attached, away from the housing 51 and in the proximal direction, and energy source 50 is activated to start liquefaction. During the liquefaction process, pressure on the tension arm 54 (arrow P in configuration (c)) is maintained and the free end of the tension arm 54 is moved closer to housing 51 or its other end further away from housing 51 and more proximal, thereby moving the anchor base in a proximal direction (configuration (c)).
[00057] The lever system 52 as shown in Figure 4 can also comprise means to control the tension of the suture and the liquefaction process or the proximal movement of the anchor base respectively. To ensure minimal tension on the suture or a straight extension of the suture when the suture is initially threaded and secured in the lever system, a cylinder 59 can be fixed to housing 51 in a resilient manner (for example, by means of a spring) to be positioned between holes 56 and 57. If the suture is passed around the cylinder 59, the cylinder takes on a loose shape in the suture and is driven away from the holes by the spring. During activation of the lever system to tension the suture, cylinder 59 is moved to its most extended position in line with the two holes. The resilience of fixing the cylinder 59 can be obtained as illustrated with the aid of a tension spring, but also with the aid of a pressure spring or any other means per se known (for example, mechanical, pneumatic or hydraulic) not not only to assume a loose suture and keep the suture tension approximately constant, but also to absorb the vibration or shock that can damage the suture.
[00058] The lever system 52 can also exercise the function of the lock as discussed together with Figures 1 and 3, in the simplest case through contact with the housing, when the anchor base has reached its most proximal position. The liquefaction process and its desired end can also be controlled through the tension of the suture by projecting a distal portion of the tensioning arm to be resilient and, therefore, to be able to tension the suture only with the maximum desired force and to just bend while applying more force. This measure to control the liquefaction process allows not only to stop the process when the thermoplastic glove is saturated, but also when the ability of the hard tissue to be penetrated by the liquefied material is saturated and when only the force of an unwanted size could put more pressure on the material into the fabric. This means that in the latter case, the liquefaction process is controlled regardless of the length of the suture under tension, and depending on the rigid tissue to which the anchor must be attached. In addition, limiting the tension of the suture, for example, in the aforementioned manner ensures that the suture is not damaged during the fixation process.
[00059] Figure 5 illustrates another exemplary embodiment of the means for securing the suture in the lever system and the means for locking the compression arm 53 and the tensioning arm 54 in the compression position. Similar items are designated with the same reference number as shown in Figure 4. Instead of compression clamps 55 as shown in Figure 4, the two arms comprise curved cooperation profiles 55. 1 that intertwine is loosened when the two arms 53 and 54 are in the compression position, in which the curves of the curved profiles have a number large enough and / or a radius small enough to sufficiently prevent a suture from extending between the two profiles to prevent movement of the suture through the vacant space between the profiles. The advantage of the fixation means according to Figure 5 is the fact that the suture does not need to be compressed and therefore be deformed in relation to the cross section, which can damage a sensitive type of suture.
[00060] The means for locking the compression arm 53 and the tensioning arm 54 in the compression position as shown in Figure 5 is a clamping connection 55. 2 comprising a protuberance on the tensioning arm 54 and a corresponding depression on the compression arm 53, in which the protrusion is resilient enough to be long within the depression.
[00061] Instead of the lever system 52 described above, the device may comprise a ratchet mechanism or simply a tongue that is inclined against a surface, for example, of the housing 51 to compress the suture end sections against this surface and that is designed to allow movement of the suture in only one direction, or it may comprise any other mechanism per se known that allows suture 4 to be fixed, straightened or tensioned and the anchor base to move with the aid of the suture and at the same time, allow the tension of the suture, in which the surgeon operates the mechanism by pulling on the ends of the suture or the mechanism comprises a limb to be handled by the surgeon. In a very simple modality of the device, there may be no means to fix, tension and move, for the surgeon to use to hold the suture and to tension it and with which he can move the anchor base.
[00062] Figure 6 illustrates the method as already mentioned above, a method that serves to fix a suture anchor after opening a rigid tissue, that is, in a cavity or in a soft tissue on one side not accessible from a layer of rigid tissue (for example, in the medullary cavity of a long bone, in a location under a layer of cortical bone where there is no spongy bone tissue, or on the inaccessible side of a bone plate or a prosthesis that replaces a bone plate). The device shown in Figure 6 is a simplified version of the device as shown in Figures 1 and 3.
[00063] The opening provided for fixing the suture anchor 2 is a so-called supracortical fixation in which the opening of the rigid tissue provided for fixing the suture anchor does not reach the rigid tissue (for example, even the bone tissue spongy beneath a layer of cortical bone), but it reaches a bone 41 from an accessible side 42 to an inaccessible side 43 thereof and in which instead of a subcortical anchorage, a supracortical device 44 is formed. This supracortical device 44 may or may not be anchored to the bone surface on the side of the inaccessible bone. The method according to which the fixation is established in a very similar way to that as described together with Figures 1 to 5.
[00064] In the simplified form of the device, suture anchor 2 again comprises an anchor base 22 and a thermoplastic sleeve 23, a loop of suture 4 that is preferably slidably attached to the anchor base (channel system and / or grooves) and end sections of the suture reaching the termoplastic sleeve 23 and a distal portion 17 of tool 1, that distal portion of tool 17 which again comprises an axial channel 11 and whose axial length is determined to be approximately equal to bone thickness 41 by the corresponding elevation position 16. In particular, when a relatively short thermoplastic sleeve 23 is used, it is possible not to use the interface piece as shown in Figures 1 and 3. Fixing the distal face of the thermoplastic sleeve 23 on the anchor base 22 or providing energy directives on the distal face 10 of the tool 1 or on the proximal face of the thermoplastic glove 23, the preferred liquefaction of the thermoplastic glove is caused at its proximal end.
[00065] If suture 4 has yet to be slidably attached by anchor base 22 and supracortical device 44 after the fixation process, it is preferable to equip anchor base 22 with a proximal protuberance in the form of a tube (not shown) ) reaching the cannulation of the thermoplastic sleeve 23 and having an axial length at least as large as the final thickness of the supracortical device 44 and / or using an interface piece as shown in Figures 1 and 3. If the ability to slide from the suture not important, the anchor base 22 can be flat as shown, and the interface piece can be omitted. Thus, the suture may or may not be locked by the liquefied material of the thermoplastic glove 23.
[00066] Obviously, for the method as shown in Figure 6, there is no need for the cross section of the thermoplastic sleeve 23 to be adapted to the cross section of the rigid fabric opening in such a way that the material glove is located in close proximity to the wall of the opening as discussed in conjunction with Figures 1 and 2. It is necessary that the base of the anchor 22, the thermoplastic sleeve 23 and preferably, the distal end of the tool 1 fit inside and through the opening and that there is material for the sleeve enough to produce a body 44 that cannot pass through opening 5.
[00067] Exemplary applications of the supracortical devices 44 established as described above are, for example, in relation to the human shoulder: stabilization of acute acromioclavicular junction; and in relation to the human foot: the fixation of syndesmosis rupture. In the mentioned applications, the suture 4 fixed by the supracortical device can be a suture roll that is used to directly replace a tendon or ligament.
[00068] Figure 7 illustrates the known double-row procedure for suturing a soft tissue into a rigid tissue, using the example of fixing a ruptured tendon by cutting rotator 60 to humeral bone tissue 61 (or a corresponding endoprosthesis) in four successive phases (a), (b), (c) and (d). Phase (a) is before the repair operation and shows the location 62 where refixing is required. In phase (b) two medial anchors 63 are attached to the bone tissue, in places to be eventually located under the tendon 60, each of the medial anchors 63 fixing at least one suture 4 to the bone tissue in a sliding way. In phase (c), the terminal sections of each suture attached to one of the medial anchors are passed through the ruptured tendon 60 and tensioning the sutures away from the tip of the tendon (not shown), the last is pulled over the medial anchors 63. In phase (d), two lateral anchors 64 are anchored in the bone tissue just beyond the edge of the tear, the row of lateral anchors 64 extending almost parallel to the row of medial anchors 63, the terminal sections of sutures 4 being tensioned and locked with the aid of the lateral anchors 64 in a crossed way, such that the two suture end sections secured by a medial anchor 63 are locked by the two different lateral anchors 64 thus forming cross bridges of suture 65 between the row of medial anchors 63 and the row of side anchors 64.
[00069] If in a double row procedure in which to establish the medial anchors 63, the methods and devices according to the invention are used, it is advantageous to establish the side anchor row using also the technical fixation based on in situ liquefaction of a material that has thermoplastic properties or even similar anchors as described above and that is still equipped to lock the suture (see Figures 8 and 9), in which each row of anchors can comprise two or more than two anchors and in which each medial anchor 63 is used to fix at least one suture 4 (two end portions of the suture) and each side anchor 64 is used to lock at least two end portions of the suture that originate from two different medial anchors 63.
[00070] Figures 8 and 9 illustrate the device and method used, for example, for fixing lateral anchors in the double-row procedure that was briefly described above in which the suture anchor that securely holds the suture is first attached to the bone tissue according to the method described above, and then the suture is locked in relation to the suture anchor in an additional step, thereby eliminating the need to tie the knot. Obviously, the modalities shown in Figures 8 and 9 are also applicable to other applications in which such locking of the suture is necessary.
[00071] Figure 8 shows the same anchor fixed as in Figure 2, where the suture which after the fixation process performed as shown in Figure 1 is slidable in relation to the anchor and is then locked in the anchor in a locking step following the fixation step, whose two-step procedure allows tensioning of the suture after completion of the fixation step. In the locking step, a plug 35 is forced and preferably welded into the proximal opening of the axial channel 32 of the anchor base 22, in which the suture can be primarily locked by being compressed between plug 35 and the anchor base 22, or primarily by the welding procedure, or by combining the two. Plug 35 is positioned and secured as soon as the suture needs to be finally locked in relation to bone tissue. In order to be welded to the anchor base, plug 35 and anchor base 22 comprise a thermoplastic material, the two thermoplastic materials being weldable to each other in a preferred manner using ultrasonic vibration energy that is coupled within the plug 35 via of applying a suitable vibration tool (not shown) to the proximal face of plug 35. It is also possible to attach plug 35 to anchor base 22 by pairing a thermoplastic plug 35 with an internal surface of channel 32 which is rough or suitably structured in another way or a thermoplastic anchor base 22 with a rough circumferential plug surface or suitably structured in another way and applying, for example, ultrasonic vibration energy to the plug while simultaneously forcing the plug into channel 32 Other methods per se known for fixing the plug 35 on the anchor base 22, and for locking the suture in relation to the anchor base are also possible .
[00072] Figure 9 shows in four successive stages from (a) to (d) another exemplary embodiment of a fixation suture so that a suture anchor 2 comprising an anchor base 22 and a thermoplastic sleeve 23 (for example, a anchor with a single piece which consists only of a material that has thermoplastic properties) with a loop of a 4 'threaded suture auxiliary (or substitute) through its base 22 is fixed in a rigid fabric opening 5 using the device and method as, for example, described together with Figure 1, in which the auxiliary suture loop 4 'assumes the function of the suture during fixation according to the invention and must be slidable in relation to the fixed anchor 2. In phase (a ), anchor 2, auxiliary suture 4 ', tool 1 and interface piece 3 are positioned for the anchoring process in a similar way as shown on the left side of Figure 1. In phase (b), anchor 2 is shown after completion of the anchoring process and after the r emotion of tool 1 and interface piece 3, in a similar way to that illustrated in Figure 2. Phase (b) also shows suture 4 that has a surgical function (for example, pair of sutures that extend from the anchors medials that are anchored in a double row procedure) and that need locking in relation to bone tissue. Suture 4 is threaded through the auxiliary suture loop 4 'and then threaded through the anchor base 22 by the suture loop 4' which is pulled out of the anchor base. In phase (c), suture 4 extends through anchor base 22 and a locking plug 35 to be fixed (for example, welded, preferably using ultrasonic vibration energy) to the proximal face of the anchor, that is, in the rest of the thermoplastic sleeve 23. The locking plug 35 advantageously enters the axial channel of the thermoplastic sleeve 23 and is also firmly attached to the latter, locking suture 4 in relation to anchor 2. A phase (c) also shows a locking tool T, the locking plug 35 being fixed to its distal end, for example, with the aid of the protrusion on the tool and the depression on the proximal face of plug 35. In phase (d) , the procedure is finished, that is, suture 4 is firmly locked in relation to anchor 2 or bone tissue respectively. As discussed, just above in conjunction with Figure 8, the effective locking of the suture can be effected by mechanical compression of the suture between plug 35 and suture anchor 2, by welding the two or by combining both.
[00073] As shown in Figure 9, it is advantageous (but not necessary) to dimension anchor 2 and plug 35 in such a way that the plug, when attached to the anchor, is flush with the surface of the bone 6. To obtain a fixation additional in the bone opening is also advantageous, however, it is not necessary to dimension the distal end portion 17 of the tool 1 in such a way that it does not fit exactly inside the bone opening 5, but so that there is a small gap between the wall of this bone opening and the distal end of the tool 17. During the liquefaction of the material of the thermoplastic sleeve 23, the liquefied material will be compressed within this gap and, in the locking step, it will be welded to the locking plug.
[00074] As already described in conjunction with Figure 8, the locking plug according to Figure 9 is preferably made of a thermoplastic material that is weldable to the rest of the thermoplastic sleeve 23 either through ultrasonic welding or comprises a material that is not it can be liquefied and a surface structure (structure with roughness or undercut, for example, filament) that is suitable for the formation of a positive connection by fitting with the rest of the thermoplastic sleeve when forced into the latter under the influence of a force compression and ultrasonic vibration. Obviously, it is also possible to use other per se known methods of fixation to fix the locking plug 35 to anchor 2 such as, for example, the application of adhesive, thermal welding, a tight connection that results in a positive fitting connection, a filament or a combination of a plurality of such fixation methods.
[00075] The advantage of using the suture anchor, fixation and locking method as shown in Figures 8 and 9 to establish the lateral row of anchors in a double row procedure is that the medial and lateral anchors can be fixed using substantially the same method and tools are used.
[00076] Figure 10 illustrates another additional step for the method according to the invention, the additional step serving to prevent suture 4 when tensioned from being damaged by the edge of the rigid tissue, located around the bone opening and / or to prevent the mentioned border is damaged by the suture. The fixed anchor 2 shown in Figure 10 is the same as the fixed anchor shown in Figure 2. In the fixing step, a fixing sleeve 36 is fixed to the rest of the thermoplastic glove 23 in substantially the same manner as described together with Figure 9 for the locking plug 35, in which suture 4 extends loosely through the fixing sleeve 36 and in which the fixing sleeve 36 is again advantageously dimensioned to be substantially flush with the surface of the bone 6 when attached to the anchor 2 or to protrude slightly from the bone surface 6.
[00077] Figure 11 is an axial section through a suture anchor 2 comprising an anchor base 22 and a thermoplastic sleeve 23 and which is suitable for the device and method according to the invention. Suture anchor 2 as shown in Figure 11 is preferably a one-piece item and preferably consists of only one material that has thermoplastic properties and is suitable for in situ liquefaction which is a characteristic of the method according to the invention . The anchor is preferably bioreabsorbent. Such a one-piece anchor is mentioned as an exemplary type of anchor just above (for example, in conjunction with Figure 9) and consists, for example, in PDLLA 70% / 30% filled with up to 30% biphasic calcium phosphate, in the which it can be advantageous to fill the material of the anchor base 22 more than the material of the thermoplastic sleeve 23 or to reinforce the material of the anchor base by integrating within it, as mentioned above, a suture sleeve or a reinforcement element , for example, a higher crystallinity polylactide or hydroxyapatite.
[00078] The suture anchor shown in Figure 11 is, for example, about 15m long and has a circular cross section with a diameter of about 3 to 4 m, the diameter of the axial channel of the thermoplastic sleeve 23 adding about 2 to 3 m. The system of channels and / or grooves 25 corresponds approximately to the system described together with Figure 1 and comprises a transversal channel 30, lateral recesses 31, a second axial channel 32 which is coaxial with the axial channel of the thermoplastic sleeve 23 and the channels angled thirds 33 connecting the recesses 31 with the second channel 5 32. In this sense, it is possible to equip the anchor with two (or possibly more than two) parallel transverse channels 30 to accommodate two sutures, the channels being radially or axially spaced each other.
[00079] The present invention also relates to a vibration tool (sonotrode) which is in particular suitable for the device and the method according to the invention, but which is also applicable to other fields in which the vibration energy, in particular, ultrasonic vibration energy should be used for fixing an implant to rigid tissue, in particular, in the field of minimally invasive surgery. The vibration tool is characterized by a stem portion and a coupling portion being fixed to the proximal end of the stem portion, in which the proximal end of the stem portion is fixed in an axial hole of the coupling portion, preferably by a press fit connection.
[00080] Figures 12 to 15 show exemplary proximal end modalities of vibrating tools 70 showing a proximal end of the stem portion 71 which is fixed in an axial bore of the coupling portion 72. Figure 12 is a side view and Figures 13 to 15 are possible axial sections. The coupling portion 72 comprises coupling means, preferably a threaded screw 73 designed to cooperate with a coupling means disposed on a source of vibration (not shown). Such a cooperative coupling means can also be designed for a bayonet-type coupling or similar coupling capable of transmitting mechanical vibration from the vibration source to the tool with the least possible loss of energy. The coupling portion further comprises the axial bore 74 into which the stem portion enters and to which the stem portion is attached, preferably by the snap connection or other possible attachments such as, for example, a thread or a bayonet-type coupling, if applicable, which has a screw rotation opposite the direction of the screw of a thread to couple the coupling portion to the source of vibration.
[00081] Compared to a vibration tool made as a single piece, the vibration tool according to Figures 12 to 15 has several advantages: it makes it possible to use portions with a very small cross-section rod; the separate manufacture of the two tool portions and, therefore, the combination of them is simpler than the manufacture of the tool as a single piece; and the stem portion and the coupling portion may be made of different materials, the stem portion of a material advantageous for the transfer of vibration and the coupling portion of a material advantageous for the coupling function. The stem portion is preferably a drawn wire, preferably an aluminum wire that has a limited bending capacity and good vibration characteristics, the coupling portion is preferably made of stainless steel, for example, implant steel 1. 4441 (X2CrNiMo 1815-3), a thread with coupling that is less likely to be damaged, in particular, if the tool has to be used more than once, for each use it must be decoupled from the vibration source. However, the rod portion or the coupling portion can also be made of titanium (preferably grade 5), aluminum or stainless steel.
[00082] As shown in Figures 13 to 15, the axial bore of the coupling portion 72 to which the stem portion 71 is fixed, preferably snapped together, can be a blind hole (Figures 13 and 14) or a a hollow hole (Figure 15) within that rod portion is pushed to any suitable depth.
[00083] The vibration tool is preferably adapted for vibration and it must be transferred to an implant such as, for example, a suture anchor and therefore has an axial length that is approximately the same as half the length of wave (possibly multiplied by a whole factor) of the vibration mentioned in the stem portion material. This half wavelength and thus the theoretically shortest tool length is for vibration with a frequency of 20 KHz: 126.5 m (titanium grade 5) and 127.5 m (aluminum); for vibration with a frequency of 25 KHz: 1.2 (grade 5 titanium) and 102 m (aluminum), the numbers being applicable for coupling the tool to the vibration source in a location with the maximum vibration amplitude. The ideal tool length, in particular for the tool with non-constant cross sections, is best determined experimentally.
[00084] The method for fixing a suture to the rigid tissue (for example, bone tissue) that has been described above relates in particular to the suture anchors suitable for fixing soft tissue to the rigid tissue. In all the described modalities of the methods for fixing such suture anchors in the rigid tissue, the sutures can be protected against damage caused by heat dissipation from the material that has thermoplastic properties when liquefied by immersion in liquid (water) or saline) preferably, before the sutures or part of it is threaded through the suture anchor, or before the sutures are positioned in the opening of rigid tissue and necessarily before the liquefaction of the material that has thermoplastic properties.
[00085] In most parts of the description above, the suture that is fixed in relation to the rigid tissue is expected to assume a surgical function when fixed, but it also has a specific function in the fixation method, namely, the function of hold the anchor or the thermoplastic sleeve against the tool respectively and move the anchor base against the tool when the thermoplastic sleeve becomes shorter. If the method according to the invention is to be used in applications other than suture fixation or in combination with sutures that are not suitable for the mentioned fixation functions (for example, not easily available as shown in Figure 9, or too fragile), it is possible to execute the method with an auxiliary suture or a substitute suture, which is used instead or in addition to the suture that takes on the surgical function and that is after the fixation removed or compressed, as it has no more function . Such a substitute suture can be any flexible elongated item such as, for example, a thread, a ribbon or a suture with suitable characteristics. In the present description, the term suture should mean not only that the sutures assume a surgical function when fixed, but also that the auxiliary suture described above or the substitute suture has only one function in the method of fixing the suture anchor.
[00086] In most of the methods described above for fixing a suture anchor to the rigid tissue, a material that has thermoplastic properties is liquefied to preferentially penetrate rigid tissue or cavities provided in the rigid tissue to constitute, when re-solidified, a connection positive fit between the anchor or part of it and the rigid fabric of the opening wall. Such positive fitting connections can also be obtained, in all cases described, in a two-step procedure, in which the walls of the rigid tissue opening are pre-treated according to a method as described in publications WO-2010/045751 or WO-2009/141252 (Nexilis), the description of which is included here in its entirety by reference. In this sense, a material that has thermoplastic properties is forced in a liquefied state into the rigid fabric of the opening wall to form together with this fabric a type of composite material substantially without coating this wall with the material that has thermoplastic properties. In a second step, the anchoring process, which is part of the method according to the invention, is then carried out as described in the present description and in the cited publications, in which the liquefied material is not able to penetrate the composite material of the opening wall. established in the pre-treatment stage, and instead it is welded to the composite material of this wall. For such welding it is a condition that the material that has thermoplastic properties used in the second stage or in the fixation stage can be welded in the material that has thermoplastic properties used in the first stage or pretreatment stage. Preferably, the two materials that have thermoplastic properties comprise the same thermoplastic polymer.
[00087] If the aforementioned pretreatment step is performed in order to form the composite material comprising rigid fabric and the material that has thermoplastic material right at the opening of the rigid fabric, this opening is reinforced and thereby has an increased capacity to withstand be cut by the suture attached to the rigid tissue opening and by the anchor attached to it when this suture is tensioned, which means that a similar effect as described in conjunction with Figure 10 is obtained.
[00088] If the pre-treatment step mentioned is performed only on an external region of the rigid tissue (for example, to reinforce a damaged or very thin cortical bone layer), the composite material comprising the rigid tissue and the material that has thermoplastic material will form a ring at the opening of the opening of the rigid tissue serving as an almost cortical layer under which the suture anchor is then anchored as shown in Figure 2.

权利要求:
Claims (15)
[0001]
Device for fixing a suture anchor (2), in a rigid tissue opening, with the aid of a material that has thermoplastic properties and the energy transmitted to the suture anchor for in situ liquefaction of at least part of the material having thermoplastic properties, the device comprising:
a tool (1) comprising a distal tool face (10) and an axial channel (11) with a distal opening located on the distal tool face (10), the distal tool face (10) being formed to contact the material having thermoplastic properties, and
a substantially tubular shaped interface piece (3) that fits within the axial channel (11) of the tool (1), and a substantially tubular shaped interface piece (3) is formed to couple with an anchor base (22 ) arranged at a distance from the thermoplastic material,
characterized by the fact that the axial channel (11) and the interface piece (3) are equipped with capture elements (12 and 12 ') that cooperate to capture the proximal end of the interface piece (3) in the axial channel (11 ) when the interface piece (3) is moved in a proximal direction in the axial channel (11).
[0002]
Device according to claim 1, characterized by the fact that the capture element (12 ') is arranged at a proximal end of the interface piece (3).
[0003]
Device according to claim 1 or 2, characterized by the fact that the tool (1) still comprises a lock (13) in the axial channel (11) capable of limiting the proximal movement of the interface piece (3), and , adjacent to the lock (13) distally, an inspection portion that allows visual inspection of the axial channel (11) in a radial direction.
[0004]
Device according to claim 3, characterized in that the inspection portion comprises a lateral recess (14) of a depth that reaches up to the axial channel (11).
[0005]
Device according to claim 4, characterized in that a portion of the tool adjacent to the recess (14) proximally comprises a groove that extends axially (15) being aligned with the recess (14).
[0006]
Device according to any one of claims 1 to 5, characterized in that the tool (1) is a sonotrode coupled or attachable to a source of vibration energy, in particular, to an ultrasonic vibration generator.
[0007]
Device according to claim 6, characterized in that the tool (1) comprises a shank portion (71) and a coupling portion (72), a proximal end of the shank portion that is fixed in an axial hole the coupling portion (72) and the coupling portion (72) which comprises a nut screw (73) in order to be coupled to the vibration energy source.
[0008]
Device according to any one of claims 1 to 7, and characterized by the fact that it still comprises the suture anchor (2) and a suture (4), wherein the suture anchor (2) comprises the anchor base (22 ) and a thermoplastic sleeve (23), where the anchor base (22) comprises a system (25) of channels and / or grooves, the suture (4) which extends in the form of a loop through the system (25) , in which the thermoplastic sleeve (23) comprises the material that has thermoplastic properties and is located between the distal face (10) of the tool (1) and a proximal face of the anchor base (22), in which the interface piece ( 3) extends from the anchor base (22) through the thermoplastic sleeve (23) and into the axial channel (11) and the end portions of the suture (4) extend from the anchor base (22) through of the interface piece (3), and where the anchor base (22), the thermoplastic sleeve (23) and the interface piece (3) are attached in relation to the distal end of the tool ( 1) by the terminal portions of the suture (4) that are held in a more proximal position and / or by the interface piece (3) that is held in the axial channel (11) of the tool (1).
[0009]
Device according to claim 8, characterized by the fact that the suture anchor (2) is a one-piece item made of only one material.
[0010]
Device according to claim 8 or 9, characterized by the fact that the suture (4) is slidably attached to the system (25) of the channels and / or grooves.
[0011]
Device according to any one of claims 8 to 10, characterized in that the capture elements (12 and 12 ') are arranged to be able to capture the interface piece (3) in the axial channel (11) when the thermoplastic sleeve has an initial axial length, or only when the thermoplastic sleeve is shortened by liquefying the material that has thermoplastic properties.
[0012]
Device according to any one of claims 1 to 11, characterized in that it still comprises the energy source (50) and means for fixing end sections of a suture (4), for straightening or tensioning the suture, and for moving the anchor base (22) with the aid of the suture (4).
[0013]
Device according to claim 12, characterized in that said means for fixing, straightening or tensioning and moving comprise a lever system (52) with a compression arm (53) and a tensioning arm (54), the compression arm being fixed to the housing (51), to the power source (50), or to the tool (1) in a rotating manner, the tensioning arm (54) being connected to a free end of the compression arm (53 ) in an articulated manner, and which further comprises means for securing the end sections of the suture (4) in relation to the lever system (52) and the locking means for locking the compression arm (53) and the tensioning arm ( 54) in a compression position.
[0014]
Device according to any one of claims 1 to 13, characterized in that the suture anchor (2) comprises the anchor base (22) and a thermoplastic sleeve (23), the anchor base (22) comprising a system (25) of channels and / or grooves with an opening on a proximal face of the anchor base (22), the system (25) being suitable for threading a suture (4) in the form of a loop through it, the glove thermoplastic (23) being arranged or may be arranged coaxially in said opening.
[0015]
Device according to any one of claims 1 to 14, characterized by the fact that the suture anchor consists entirely of a material that has thermoplastic properties and is suitable for liquefaction in situ with the aid of vibratory energy, in particular, with ultrasonic vibrating energy.

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同族专利:

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公开号 | 公开日

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KR20140022758A|2014-02-25|

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ES2516190T3|2014-10-30|

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EP2618747B1|2014-07-16|

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US8545536B2|2013-10-01|

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CN103220989B|2015-11-25|

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RU2013118032A|2014-10-27|

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CA2811343C|2020-04-07|

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HK1187229A1|2014-04-04|

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BR112013006697A2|2016-06-07|

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IL248305A|2019-06-30|

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KR102058812B1|2019-12-23|

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JP6057900B2|2017-01-11|

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EP2807981B1|2020-04-22|

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PL2618747T3|2015-03-31|

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WO2012037700A1|2012-03-29|

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KR20180127521A|2018-11-28|

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JP2013540494A|2013-11-07|

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CA2811343A1|2012-03-29|

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IL225143A|2016-10-31|

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RU2570969C2|2015-12-20|

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KR101922264B1|2018-11-26|

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EP2618747A1|2013-07-31|

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US20120095506A1|2012-04-19|

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IL248305D0|2016-11-30|

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CN103220989A|2013-07-24|

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EP2807981A1|2014-12-03|

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法律状态:
2018-03-27| B15K| Others concerning applications: alteration of classification|Ipc: A61B 17/04 (2006.01), A61B 17/00 (2006.01), A61B 9 |

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2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

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2019-09-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

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2020-04-14| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

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2020-06-23| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/09/2011, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US38616010P| true| 2010-09-24|2010-09-24|

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US61/386,160|2010-09-24|

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US201161437227P| true| 2011-01-28|2011-01-28|

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US61/437,227|2011-01-28|

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PCT/CH2011/000223|WO2012037700A1|2010-09-24|2011-09-21|Device and method for fixating a suture anchor in hard tissue|

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