Spinal stabilizing and guiding fixation system

[0001] Children's scoliosis (EOS) is a pathology that begins to affect children usually before the age of ten (10). Untreated lateral curvature of the spine can gradually increase, leading to severe deformity of the chest and some organs. Generally, two surgical options are available. The first consists in anastomosis of the spine changed by lateral curvature, which stops the development of the chest at an early age. The second option is to treat the spine with some forms of growth-guiding implants, which usually need to be repeatedly adjusted or replaced during the patient's childhood. Typically, these additional adjustments and replacements require additional surgery.

[0002] It is desirable to develop easy-to-use implant systems and methods for using them to stabilize and control spinal growth and to treat spinal defects such as EOS.

US 2006/0241594 A1 discloses a system for stabilizing the spine. The elongated bracket is attached to the vertebra by means of anchoring elements. The first type of anchoring elements connects the longitudinal brackets in a way that prevents their axial movement, while the second type allows this type of movement. The anchoring elements include a set screw, which can be screwed in various ways, ensuring correspondingly limited and unlimited anastomosis.

US 6,440,132 B1 discloses an open medical implant into which it is inserted and fastens it to the bone.

longitudinal support and which

The implant closure includes an upper plate with a setscrew hub. The screw is screwed to fix the longitudinal support in the implant.

US 2004/0111088 A1 discloses an assembly for attaching an elongated bracket to the vertebral bodies. The joining element comprises two channels into which longitudinal brackets are inserted. The longitudinal brackets are attached with set screws closing the channels.

US 2007/0161987 A1 discloses a connector assembly for connecting the longitudinal support to the patient's spine. The assembly includes a connector into which the longitudinal bracket is inserted, in which the spherical sleeve surrounding the longitudinal bracket is inserted into the connector seat. The position and direction of the longitudinal bracket and connector assembly can be adjusted and locked using a clamp.

US 2007/0161994 A1 discloses a bone anchoring device. A part of the head of the device is hingedly connected to a part of the nut, where a substantially spherical hollow is formed between the part of the head and the nut. The longitudinal support is inserted into the ball connector, which in turn is inserted into the ball hollow. The direction of the longitudinal support can be adjusted by turning the spherical connector and locking it.

SUMMARY OF THE INVENTION [0003] The present invention relates to an implant system, and more particularly to an implant system and lead connector for the treatment, correction or stabilization of a spine with defects or damaged, and more specifically to the treatment of childhood scoliosis (EOS). The present invention relates to the system as claimed below. Preferred modes for carrying out the invention are set out in the dependent claims. [0004] Preferably, the implant system stabilizes the spine and directs, controls and indicates the direction of spinal growth along a predetermined path. The system preferably includes one or more longitudinal brackets, typically one or more rods implanted in a particular position that direct the growth of the spine allowing the development of the vertebral vertebrae but which limit and control this growth in a particular direction and along a particular path. In addition, the system preferably includes one or more fixed bone anchors that are stably attached to the vertebrae and one or more lead fasteners that are stably attached to the vertebrae but which can slide along the bars. Fixed bone anchoring elements act as attachment points for bars, which preferably act as rails or guide bars. Leading connectors can move relative to the bars, and their guidance through the bars directs the growth of the spine. Leading (or sliding) connectors allow passive growth and elongation of the spine. [0005] In one embodiment, the system for stabilizing and directing growth of the spine includes (i) one or more elongated brackets, preferably longitudinal bars of a specified width and length; (ii) one or more lead fasteners with a bone fastener portion and a lead portion where the bone fastener portion has been configured and adjusted to securely fasten the lead fastener to the vertebra and the lead portion has a support member with one or more configured passages and fitted to the longitudinal brackets, where the support element allows relative sliding movement of the longitudinal brackets in the transitions of the support element; and (iii) one or more bone aggregate elements with a channel intended for the longitudinal support, locking mechanism and bone anchoring portion that has been configured and adapted to securely attach bone aggregate components to the bone to provide a stable attachment point, and the locking mechanism has been configured and fitted for stable fastening of the longitudinal bracket in the channel. The lead connectors have been configured so that they can slide along the longitudinal brackets, preferably to allow and control the growth of the spine along a predetermined path.

[0006] The bone fastener of the lead fastener and the bone anchoring part of the bone fastening element may preferably be from the group of hooks, bolts, wide head nails, pins, nails, blades, screws and clamps. The bone fastening portion and the bone anchoring portion may be uniaxial, single turn, or pivotable about multiple axes with respect to the second leading link portion or bone joining element.

[0007] In another embodiment, the lead fitting has a transverse notch in the bone connecting part, and the leading part additionally includes a platform element with one or more flexible panels with a defined internal and external surface and a connecting part for attaching the platform element to the bone connecting part, wherein the lobes bend around the longitudinal brackets to form at least part of the support element and, where the leading connector additionally includes a cable, which has been configured to extend around the outer surface of the panels and through a cut-out to attach the longitudinal brackets to the support formed by the panels. In one embodiment, the linkage portion articulatedly secures the platform member to the bone linkage portion. Preferably the platform element comprises a protruding element and at least two bendable panels, which protruding element and panels form at least two cavities for the longitudinal brackets and which form at least part of the support element for the longitudinal brackets.

[0008] The system may further include devices for use with implants, such as, for example, a lead connector holder. The lead connector grip may include a distal grip with a channel, a proximal grip with a channel and a portion of the grip with a distal and proximal end shaft, which proximal end includes a restraining member. The proximal chuck channel is introduced through the distal end of the handle part and moved relative to the shaft, and its purpose is to secure the clamping band to the handle part. The channel of the distal grip is introduced through the distal end of the handle part and the purpose of the platform or its element and band is moved relative to the shaft, is to secure the panels, the housing of the clamping lead connector to the handle part.

[0009] Other implants used with the system include parallel abutments. In one embodiment, the parallel connector has a housing in which there is a hook for securing and optionally permanently attaching at least one longitudinal bracket and a notch for the sleeve, which sleeve has a hole in which the longitudinal bracket is inserted and which allows it to move in situ. In another embodiment, the parallel connector has a housing in which there are two holes, two notches and external sides, which both notches extend from the outside of the housing into the interior of the holes. The holes are large enough to slide longitudinal brackets into them, and the size of the cutouts is smaller than the width of the longitudinal bracket, which allows the longitudinal bracket to be secured in the holes. The flexibility of the housing allows the elongated bracket to pass through the cutout and into the holes. In addition, there is a cable channel in the housing on the outside that extends at least around some of the holes, which cable is inserted into the channel to fix the longitudinal brackets in the holes and to allow the longitudinal brackets to be moved relative to the housing. DETAILED DESCRIPTION OF THE DRAWINGS [0010] The accompanying drawings help to better understand the summary presented previously, as well as a detailed description of preferred embodiments of the application, which is given below. The drawings have been shown for illustrative purposes of the preferred implant system and method of applying the present invention. It should be remembered, however, that the application is not limited to the exact arrangements, structures, properties, embodiments, aspects, methods and measures presented, and the presented arrangements, structures, properties, embodiments, aspects, methods and measures may be used alone or in combination with other systems, structures, properties, examples, aspects, methods and means. In the drawings:

[0011] Figure 1 is a top view of the stabilization and guiding spine system of the present invention that directs growth of the spine along a predetermined path implanted in the patient's spine according to a first attachment configuration;

[0012] Figure 2 is a perspective view of the embodiment given for illustrative purposes of a lead connector that can be used in the stabilization system of Figure 1;

[0013] Figure 3 is a top view of a schematic representation of the stabilization system and the leading spine of the present invention using a lead connector according to a second attachment configuration;

[0014] Figure 4 is a top view of a schematic representation of the stabilization system and the spine guiding object of the present invention using a lead connector according to a third preferred attachment configuration;

[0015] Figure 5A is a side perspective view of the first preferred embodiment of a lead connector according to the present invention;

<td> [0016]</td><td>Figure 5B</td><td>presents</td><td>Hello</td><td>liaison</td><td>bones</td>

<td>linker</td><td>leading</td><td>of Figure 12A;</td><td></td><td></td><td></td>

<td> [0017]</td><td>Figure 5C</td><td>presents</td><td>Hello</td><td>liaison</td><td>bones</td>

<td>linker</td><td>leading</td><td>of Figure 5A;</td><td></td><td></td><td></td>

<td> [0018]</td><td>Figure</td><td colspan="2">5D presents</td><td>side</td><td>view</td>

<td colspan="2">perspektywistyczny</td><td colspan="2">leading connector from</td><td>Figures 5A,</td><td>which</td>

it is pre-connected to the bone connector part, which is connected to the leading part before the rods are introduced;

[0019] Figure 6A is a side perspective view of a second preferred embodiment of a lead connector according to the present invention;

[0020] Figure 6B is a side perspective view of the alternative lead connector structure of Figure 6A;

[0021] Figure 6C is a side view of the lead connector of Figure 6A with a pre-mounted hose clip.

[0022] Figure 6D is a top view of the lead connector of Figure 6B schematically attached to the vertebrae according to one method as part of the stabilizing and leading spine system;

[0023] Figure 7 is a perspective view of the lead connector of Figure 6C and the cable tie assembly pre-attached to the implant holder;

[0024] Figure 8 shows parts of the lead connector and implant holder of Figure 7;

[0025] Figures 9A-C show the steps of mounting the lead connector and implant holder device to a screwdriver;

[0026] Figure 10 is a perspective view of the parallel connector; and [0027] Figure 11 is a perspective view of the parallel connector.

DETAILED DESCRIPTION OF THE INVENTION [0028] In the following description, specific terminology has been used only for the convenience of the reader and is not a limitation. The words 'right side', 'left side', 'bottom', 'top', 'below', 'above', 'up' and 'down' determine the directions in these drawings. The words "internally" or "distally" and "externally" or "proximal" refer to the directions toward the geometric center of the spinal stabilization device, system or surgeon or the opposite direction, respectively, and are not limiting. The words "front", "back", "up", "down", "side" and "middle" and related words and / or phrases mean the beneficial positions and directions in the human body discussed and are not limited. Terminology includes the words listed above, words derived from them, or words with similar meanings.

[0029] Some preferred embodiments of the invention will be discussed below with reference to the drawings. Generally, these embodiments relate to preferred spine stabilization systems and growth management systems, preferably including lead connectors and associated devices, which examples are not intended to limit use during spinal treatment.

[0030] Referring to Figures 1-4, a first preferred embodiment of the stabilization and lead system of the implanted spine configuration 100 in spine 7 has been shown as having three different attachments. The spine stabilization system 100 is preferably used in the spine and can be used in its cervical, thoracic and / or lumbar segment. The spine stabilization system 100 may be of particular use for the correction of childhood scoliosis. Although the system 100 has been described as being generally intended for use in the spine, it may have other uses and may be used as a system and device for bone fixation or stabilization for use on other bones or joints such as, for example, arm, elbow, wrist, hand , finger, skull, jaw, ribs, hips, knees, ankles, feet, toe, limbs and can be used in non-orthopedic and / or non-medical applications.

[0031] The spine stabilization system 100 may include (1) one or more elongated brackets 9, such as, for example, longitudinal rods 10, (2) one or more standard vertebral joining devices 15 for fastening the vertebra to longitudinal brackets, such as, for example, screws trans-basic (single-axis, single-turn, multi-axis bolts), plate and trans-basic hooks (single-axis, single-turn and / or multi-axis hooks) or other bone anchoring elements, which can be stably attached to one or more vertebrae, preferably to act as anchor points, (3) one or more lead connectors for anchoring in the vertebra and for navigating and controlling the movement of the vertebrae along the longitudinal supports 9 in such a way that the vertebral vertebrae 7 can move along the growth path to allow growth of the spine 7 and chest, (4) one or more lateral connectors for lateral displacement of the connectors from the axis of the spine; and (5) one or more parallel connectors enabling the relative movement of the longitudinal brackets.

[0032] It should be remembered that the longitudinal support 9 is usually a bar 10, but there is no limit to using the system only with the bars and the use of longitudinal supports of any shape and configuration may be considered. The bracket 9 may include durable, unstable, concave, semi-permanent, flexible or dynamic rods 10. The rods 10 for use in the stabilization system 100 may be standard rods commonly used during spinal stabilization surgery, typically with a diameter of approximately 6 mm. However, for pediatric use for which this system may be specifically adapted and designed, the use of 5.5 mm rods may be preferred. Alternatively or additionally, the system may use dynamic rods to allow the rod implanted in the patient to stretch.

[0033] The longitudinal supports 9, hereinafter interchangeably referred to as rods, act as guide rails that guide the growth of the spine. This means that in one preferred embodiment, the surgeon inserts the bars so that they match the desired growth path for the patient. The rods are preferably stably attached to one or more vertebrae that act as anchor points. The rod is implanted in such a way that it corresponds to the desired growth path of the spine by supplying or bending the rod to the desired configuration. Then, the lead connectors are preferably connected to the remaining vertebrae and can move and slide along the rods to allow passive growth and elongation of the spine. The bars act as guide rails, which navigate and control the movement of the lead connectors, thus controlling the direction of growth of the vertebrae to which they are attached. Fixed anchor points for the stabilization and leading systems can be placed at the ends or in the center of the structure.

[0034] The possibility of attaching bone anchoring elements and / or lead connectors to the vertebrae by means of multi-axis, uniaxial or single-turn screws, hooks, pins, wide-head nails, nails, pins, blades or other types of bone anchoring mechanisms or clamps is highly appreciated. Optionally, the system may include one or more adapter 12 for fastening two parallel bars 10, 10 'implanted in the patient's spine 7.

[0035] Referring to Fig. 1, the first preferred spine stabilization system 100 and attachment configuration include a first pair of longitudinal brackets 9, typically rods 10, placed longitudinally on the posterior side of the spine on one or both sides of the spinous process 8 of the spine 7 stably attached to the anastomoses pedicle

Bars 10, 10 ', 10' ', 10' '' are vertebrae using standard bolt elements, standard bolt channel used for e.g.

15. The body usually includes insertion of the rod and a locking cap or mechanism for attaching the rod 10, 10 'to the puncture screw 15. The puncture screw used in the spinal fusion assembly 100 has been disclosed in WO 2009/015100 A2. The bone stabilizing element 15 may include a body rotating with respect to the bone anchoring element, commonly known as multi-axial trans-base screws or multi-axis hooks. Consideration may also be given to the use of uniaxial or single-turn screws and / or hooks for use with the stabilizing and leading system of the spine 100. The use of other bone-joining elements with the stabilizing and leading system 100 may also be considered.

[0036] As shown in Fig. 1, the system 100 can be hooked to the upper vertebrae 1, 2 and the lower vertebrae 5, 6 by means of standard pedicle screws 15 that place the bars 10, 10 ', 10' ', 10' '' in fixed position relative to the attached vertebrae. In the example shown in Fig. 1, four (4) standard pituitary screws 15 are implanted in circle 1 and 2, and four (4) standard pituitary screws 15 are implanted in circle 5, 6. Two rods

10, 10 'extend extensively parallel from the upper vertebra 1, 2 towards the lower vertebrae 5, 6, and two 10' ', 10' '' rods extend extensively parallel from the lower vertebrae 5, 6 towards the upper vertebrae circles

1, 2, i.e. all four (4) bars are used in total.

Two 10, 10 'rods that extend from the upper vertebrae

1, 2 cut across two intermediate rings 3, 4, and two 10 '', 10 '' 'bars that extend from the lower vertebrae

5, 6 also cut across the two intermediate circles 3, 4 in such a way that all four (4) bars 20 preferably extend through at least part of the intermediate circles 3, 4. Four (4) bars 10, 10 ', 10' ', 10' '' are preferably largely parallel and allow telescopic extension of the system and allow spinal growth and relative movement of the vertebrae 2, 3, 4, 5. The structure of Fig. 1 is hereinafter referred to as the parallel structure. The parallel structure is hooked distally and proximal, and in the middle it is possible to use a telescopic extension by using 20 lead connectors.

[0037] The sliding and leading connectors 20 are attached to the intermediate vertebrae 3, 4. The leading connectors 20 preferably allow the spine to grow and elongate. In particular, the distance between adjacent vertebrae may change as the patient grows, because the 10, 10 ', 10' ', 10' '' bars can move and fold telescopically relative to the lead connector 20.

[0038] Preferably, the lead connector 20 should be stably attached to one or more vertebrae so that the lead connectors can slide and slide relative to the bars as the spine increases. Leading connectors 20 preferably include a bone connecting portion 30 and a leading portion of a rod 40. In the embodiment for illustrative purposes in Fig. 2, the bone connecting portion 30 is a screw 35 including a portion of a screw shank 37 with a longitudinal axis 39. Although in the embodiment of Fig. 2 for illustrative purposes the bone fastener has been illustrated and described as a screw 35, it may be important that the bone fastener 30 may include multi-axis, single-axis or single-turn screws, hooks, pins, blades, pins, nails , clamps and anchoring mechanisms of other types of bones that are currently known or will be discovered later.

[0039] The lead portion 40 of the lead screw 35 includes at least one carrier 50 with one or more passes. The lead portion 40 of the embodiment of Fig. 2 preferably has two (2) passages 42, 44, which are inclined, preferably usually perpendicular to the longitudinal axis 39 of the shank 37 of the screw 35. The passages 42, 44 extend through the lead portion 40, allowing insertion through not rods. The size and dimensions of the passages 42, 44 allow the rods to slide through the lead portion 40 during implantation of the system in the patient's body. In this way, passages 42, 44 preferably have a diameter PD close to the diameter of RD of bars 10, 10 ', 10' ', 10' '' and preferably 42, 44 serve as bearing sleeves. Larger width In passages (e.g. larger length of bearing sleeve) potentially facilitates sliding and insertion of the bar into the passage. Exemplary widths in the carrier 50 are approximately 1 to 10 mm. The use of a support element 50 with a different width W may be considered depending on many factors.

[0040] Alternatively, the leading portion 40 may include two passages 42, 44, which extend substantially perpendicular to the longitudinal axis of the shank 37, but are open in the upper part, forming a channel 55, 57 connected to the holes 52, 54. Channel 55 , 57 enables the surgeon to latch rods 10, 10 'from the top of the lead fitting 20, making it easier to move the system assembly 100. The size of the channels 55, 57 is preferably smaller than the width or diameter RD of the rod 10 in such a way that the rod 10 is limited by the leading part 40 and cannot be easily detached from the leading connector 20. After placing the rod in the passages 42, 44 the element 58, the cable or band 62 can close the channels 55, 57 to prevent detachment of the rod 10 from the lead portion 40 during implantation into the patient's body.

[0041] The construction materials for the leading part 40, and in particular for the support element 50, are preferably chosen so as to minimize friction and wear between the inner surface 43, 45 forming the passages 42, 44 and the bars 10, 10 ', 10' ', 10 '' '. The material forming the passages 42, 44 or at least the surface 43, 45, which acts on the 10, 10 ', 10' ', 10' '' bars and comes into contact with them can be made of PEEK or very high molecular weight polyethylene (UHMWPE ). The bone rod and / or bone connector part 30 may advantageously be made of metals such as e.g. titanium, titanium alloys (Ti-6Al-7Nb), stainless steel, cobalt chromium alloys, nitinol etc. Rods and / or internal surfaces 43, 45 passages 42, 44 can be ground or coated, for example with polytetrafluoroethylene, to reduce the coefficient of friction, which in turn enhances the sliding and / or sliding characteristics of the bars 20 in the passages 42, 44.

[0042] The leading portion 40 may include a housing 65, which at least partially and preferably completely surrounds the sides of the carrier 50 preferably to provide support and reinforcement for the carrier 50. The housing 65 may be attached to the bone connector part 35 in a number of ways among others by welding, welding, gluing, pressing, threaded, integral and monolithic connections, etc. The housing can be made of biocompatible metals, metal alloys or other materials. The passages 42, 44 and the support element 50 are preferably attached to the housing 65 and the bone connector part in such a way that the passage for the rod is not adjusted before, during or after implantation of the lead connector 20.

[0043] In the stabilization and lead system 100, the rod 10 can slide through the passage 42 located in the lead connector 20 implanted into the circle 3 and through the passage 42 of the lead connector 20 implanted into the circle 4, as a result of the movement of the circle 2 in relation to the circle 3 and 4 (or circle 3 relative to circle 4). In addition, the rod 10 'can preferably move and slide in the passage 44 of the lead connector 20 implanted in the vertebra 3 and the passage of the lead connector 20 implanted in the vertebra 4, as a result of the movement of the vertebra 2 relative to verse 3 and 4 (or vertebra 3 relative to vertebra 4). The bar 10 '' can move and slide in the passage 44 of the lead connector 20 implanted in circle 3 and in the passage 44 of the lead connector 20 implanted in circle 4, as a result of the movement of circle 5 relative to circle 3 and 4 (or circle 3 relative to circle 4). In addition, the rod 10 '' 'can preferably move and slide in the passage 44 of the lead connector 20 implanted into the circle 3 and the passage 44 of the lead connector 20 implanted into the circle 4, due to the movement of the circle 5 relative to the circle 3 and 4 (or circle 3 relative to the circle 4). In this way, the system allows the vertebrae that are attached to the lead connectors to move relative to the path determined by the shape and configuration of the implanted rods.

[0044] The lead portion 40 has been designed and configured so that it can move along the bars, which preferably limits the movement of the lead connectors along a particular path and / or in a certain direction. The attachment, and preferably the stable attachment of the lead connector to the vertebrae, allows the growth and movement of the vertebrae and the growth of the spine, but preferably the growth and movement are limited to the path allowed and defined by the implanted rods. The bars 10, standard joining devices 15 (e.g., pedicular screws) and lead connectors 20 can be positioned in the spine 7 in various configurations, such as the configuration of Fig. 1, where the standard transbital fastening screws 15 that engage and fasten the 10, 10 ', 10' ', 10' '' rods with respect to the vertebrae are positioned and attached to the vertebrae at the ends of the implanted system 100, while the lead connectors 30 are attached to intermediate vertebrae 3, 4 sandwiched between immobilized end vertebrae.

[0045] Although the system 100 has been shown to have fixed bone anchors 15 in two adjacent vertebrae at the ends of the implanted system, the fixed bone anchors 15 can be attached to a single vertebra using one or more pairs of fixed bone anchors 15 and / or fixed bone anchors may extend into one or more vertebrae. In addition, although the system 100 of Fig. 1 has been illustrated and described as laterally implanted on both sides of the spinous process 8, the use of the system on the right or left of the spinous process 8 may be considered. [0046] In Figure 3 another configuration of the stabilization and lead system 100 'is shown, in which standard transplantation screws 15 they are attached to intermediate vertebrae 3, 4, and lead connectors 20 are attached to end vertebrae 2, 5. More specifically, the two standard pedicle screws 16, 17 are attached to the intermediate vertebra 3, and the two standard bolts 18, 19 are attached to the adjacent vertebra 4. The first rod 10 is stably attached to the pedicle screws 16, 18, while the second rod 10 'is firmly attached to the standard pituitary screw 18, 19. Preferably, the bars 10, 10 'are curved and correspond to the appropriate curvature of a healthy, normal spine and assist in determining the growth path for the vertebral column.

[0047] Leaders 20 are attached to first circle 2 and last circle 5. Leaders 20 are preferably in the form of bolts 35 with leading portion 40 as shown in Figure 2, but may be any of the embodiments described and illustrated herein or their modifications. The leading portion carrier 50 may include multiple passages 42, 44 for bars 10, 10 ', or each end coil 2.5 may include one or more leading connectors 20, each having a carrier 50 comprising only a single passage 42 for a single bar.

[0048] The system and structure 100 'of Fig. 3 preferably stabilizes the apex of scoliotic curvature. The term "vertex" as used herein means the center of curvature of the scoliotic deformation and is at the center of the curve. Preferably, the apex will include the onset of pathology, and its active therapy preferably means focusing. Stabilizing the apex on the cause will cause deformation.

joining and immobilizing the center of curvature. However, the final vertebrae 2 and 5 will be able to slide relative to the intermediate vertebrae 3, 4, and the system 100 'will direct this path along the direction and curvature of the bars 10, 10'.

[0049] In another configuration of the stabilization and lead system 100 '' illustrated in Fig. 4, the system 100 '' uses standard transbital screws 15 on the end circle 2 to fix the position of the bar 10, 10 'in relation to circle 2 and only one end of the structure system. System and design

100'

FIG.

are intended to stabilize the curvature of the spine 7 at the end (vertebra 2) and allow the spine to grow outside the vertebra 2. In particular, the system 100 '' of Fig. 4 includes bars 10, 10 'attached to standard transbasic screws 15 in vertebra 2. Rods 10, 10 'extend through the lead connectors 20 attached to the vertebrae 3, 4 and 5. Rods 10, 10' extend through the passages 42, 44 located in the carrier 50 of the leading part 40 of the lead connectors 20. Leading connectors 20 can move along rods 10, 10 'allowing and allowing passive growth and elongation of the spine, preferably along a path initially fixed by rods 10, 10'.

[0050] Figures 5A-5D show a first preferred embodiment of a lead connector 320 for use in a lead system for stabilizing the spine and providing growth path. Lead fitting 320 includes a bone connecting piece 330, preferably in the form of a pedicle screw 337 and a leading portion 340. The leading portion 340 includes a platform member 365 with panels 380 and 385, a central projecting member 390 and a connecting portion 395. The 395 connecting piece connects the 365 platform with the bone connecting piece 330. The link portion 395 has flexible tabs 396 that preferably snap into a recess 333 in the link link portion 330. The flaps 380, 385 have an inner and an outer surface, preferably they are flexible and bendable, and can be used to attach one or more rods 10 to lead fitting 330. Part of platform 365 (preferably the protruding element and panels) is preferably made of plastic or other polymer, preferably PEEK or very high molecular weight polyethylene (UHMWPE) to facilitate the displacement and movement of rods through panels 380, 385. The central protruding element 390 is optional. preferably separates the two bars and preferably provides a support surface to facilitate the relative movement of the bars in the platform member 365. In addition, panels 380, 385 and / or platform element 365 can be made of metal, metal alloy or other materials reinforcing and supporting the platform element 365. In addition, the bearing surfaces can be ground or coated with materials facilitating the sliding movement of the bars in the folded panels 380, 385 and through these patches.

[0051] In use, the bars 10 are introduced through the upper cutout 361 in such a way that they rest in a recess or cavities 393 formed between the central protruding element 390 and the panels 380, 385. After placing the bars 10 in the platform element 365 one of the panels 380, 385 is bent and stretched around the bars. Then the second panel 380, 385 is bent around the bars 10 and the first panel 380, 385. The clamp 362 is introduced through the opening 333 and extends around the outer surface of the bent panels 380, 385. It is clamped to immobilize the bars 10 relative to the lead connector 330 to allow sliding movement of the bars 10 relative to the lead connector 330. The movement of the lead connector 320 along the bar limits vertebral movement and growth, preferably along a predefined path. To strengthen and facilitate the bent nature of panels 380, 385, panels may have edges 398 formed along their width 380, 385. Clamp 362 also facilitates the attachment of platform element 365 to the link portion 330 of bone.

[0052] Although the lead connector 320 has been shown and described as having two (2) panels 380, 385 and one central protruding member 390 forming two (2) depressions or recesses 393 for two (2) rods 10, 10 ', it may be relevant the fact that the platform element may comprise only one panel, no protruding element 390 and only one depression 393 for one rod. The platform element may also be configured for more than two rods and may include two or more protruding elements 390, two or more cavities 393, and more than two panels.

[0053] In Figures 6A-C a second preferred embodiment of a lead connector 420 for use in a system stabilizing the spine and limiting and / or facilitating the growth of the spine 7 along a predefined path is shown and illustrated. Lead connector 420 includes a bone connector portion 430, preferably in the form of a screw 437 with threads for anchoring in the vertebra. Lead connector 420 further includes a leader portion 440 attached to the link portion 430 of the bone. The connecting piece 440 includes a platform element 465, one or more panels 480, 485 and a central projection 490. The leading connector 420 is similar to the connector 320 described above. Platform member 465 is attached to the bone link portion 430 in a manner that preferably provides passage 433 for the tourniquet 462, as shown and described below.

[0054] The link mechanism 495 includes two brackets 496, 496 'extending from the link portion 430 of the bone. The brackets 496, 496 'have holes, while the central ridge 490 of the platform element has a hollow 453 (not shown). Rivet or screw 499 is introduced through holes 497 and a hollow 453 to attach panels 480, 485 to the connecting part 495. Pin 499 in the holes

497 and hollow 453 preferably allows rotation, twisting and twisting of platform member 465 relative to bone fastener 430. The bendable and flexible panels 480, 485 may extend as shown in Fig. 6A, or alternatively may be curved, forming recesses or recesses 493, 494 for rods 10. The leading portion 440 may also include only one panel 480 and one central projection 490 'as shown in Fig. 6B. Additional panels, projections and optional recesses 493 may be available in lead portion 440. [0055] During use, rods 10 are inserted from above into cutout 461, with each rod 10 being inserted on one side of lead fitting 420 so that each rod 10 was placed between the projection 490 and the panel 480, 485. After the rods 10 have been adjusted to the desired positions, the clamp band 462 is introduced through the passage 433, wrapped around the panels 480, 485 and clamped to attach the rods 10 to the lead connector 420. Fig. 13C illustrates the clamp band 462 introduced through the passage 433. Embodiments illustrated in Figures 13A and C may accommodate two rods, while the embodiment illustrated in Fig. 13B has been designed to hold a single rod. FIG. 13D illustrates a system using a 420 'lead connector implanted into the schematic spine. Platform element 465 preferably forms a support element with protruding element 490 and flaps 480, 485, preferably formed to facilitate and favor relative movement of rods 10.

[0056] Lead fitting 320, 420, 420 'and clamping band 462 can be implanted using the implant holder 425, which is illustrated in Fig. 14. The implant holder 425 includes part of the handle 426, the distal handle 427 and the proximal handle 428. The proximal handle has a channel 422 and is introduced through the distal end 421 of the implant holder 425. Part of the stem 423 of the implant holder 425 is inserted through the channel 422, and the proximal holder 428 is moved up the stem 423 of the handle part 426 in such a way that it is loaded and preferably contacts or adjacent the stop 429. The distal handle 427 has a channel 424 and the distal tip 421 of the handle portion 426 is inserted through the channel 424. The distal handle 427 is moved up the shank portion 423 of the handle part 426 so that it is near the proximal handle 428 previously loaded on the handle part 426. The implant holder 425 with proximal and distal handles 427, 428 adjacent the stop 429 is in position ready to insert into it and connect the lead connector 420 and cable tie 462.

[0057] To load the lead connector 420, 420 'and the cable tie 462 on the implant holder 425, the distal tip 421 of the stem 423 of the handle portion 426 is positioned adjacent to the central projection 490, 490' of the lead connector 420, 420 '. Hose clamp 462 is introduced through passage 433 before or after placing lead connector 420, 420 'adjacent to implant holder 425. Plates 480, 485 and the band 462 are preferably bent and tilted up to position along the sides of the stem member 423. Then, the distal handle 427 is slid down the stem portion 423 towards the distal portion 421 of the handle portion 426. The ends of the tie clip 262 are inserted through channel 424 of distal handle 427, and distal handle 427 is slid further down the shank 423 until flaps 480, 485 are also included in channel 424. The distal handle 427 may mate with an incision or other retention mechanism to hold the distal handle 427 at the proximal end 421 of the handle portion 426, holding the clamp band 462 and lobes 480, 485 in the implant holder 425.

[0058] The optional proximal chuck 428 is then slid down the shank 423 towards the distal end 421 of the handle portion 426, and the ends of the clamp band 462 are inserted through the channel 422 of the proximal chuck 427 to hold the ends of the clamp band in part of the handle 426. In this way the clamp 462 and the lead connector 420 are charged on the implant holder 425 and held thereon, as shown in Fig. 7 and are ready to be inserted into the tool to attach lead leader 420 to the desired bone. Lead abutment 420, 420 ', band clip 462 and implant holder 425 can be pre-assembled, packaged, sterilized and sold as a whole, or individual parts can be delivered separately and assembled before or during a surgical procedure.

[0059] The steps for inserting the lead connector, the cable tie, and the implant holder 425 into the drive tool are illustrated in Figures 9A-9C. The drive tool facilitates the delivery of torque to the lead connector 420 to attach it to the coil. The drive tool 434 is preferably configured as a concave sleeve 439 with a central cannula and torque transmitting connector at its distal end. The torque transmission connector has been designed to connect and interact with a mechanism or structure on the lead connector to transmit torque to the lead connector.

[0060] The implant holder 425 with the pre-mounted abutment 420, 420 'and the clamp band 462, which are illustrated in Fig. 7, is inserted into the proximal end of the drive tool 434 and down the concave sleeve 439, which is shown in Fig. 9A until until the distal grip 427 touches and rests against the proximal end of sleeve 439. The implant holder 425 with the lead connector 420 and the clamp band 462 is further inserted into the sleeve 439 in such a way that the distal holder 427 moves proximal towards the proximal holder 428 and stop element 429, as shown in Fig. 9B. Implant holder 425 and shaft 423 are further moved down the sleeve 439 (where distal and proximal handles 427, 428 are moved towards the stop element 429) until the lead connector 320, 420, 420 'extends beyond the distal notch of the sleeve 439, as shown in Fig. 9C. The implant holder 425 can extend into the sleeve 439 until the stop element 429, proximal holder 427 and the distal holder 428 touch or abut, as shown in Fig. 9C. In this way, a smooth push of the implant holder 425 causes the holder 425 to freely move to the drive tool 434, so that the distal and proximal holder 427, 428 will move back automatically.

[0061] In Fig. 10 a parallel connector is shown. Parallel connector 820 has a leading portion 840, but no bone connector. The lead portion 840 has a housing 865 that includes a hook portion 867 that is preferably firmly attached to the rod 10 by a set screw. The set screw is optional and can be omitted, allowing rod 10 to move relative to housing 865. Housing 865 also includes a sleeve 850, preferably a sleeve 850, which can rotate about a plurality of axes relative to the housing 865. The sleeve 850 has an opening 842 through which a rod 10 'is inserted. The rod 10 'can preferably move and slide through the sleeve 850 in a direction relatively parallel to the axis of the rod 10.

[0062] An alternative parallel connector is shown in Fig. 11. Parallel connector 920 includes a leading portion 940, but not the bone connector. The leading portion 940 has a housing 965, which preferably includes one or more holes 942, preferably configured as supporting elements for bars 10, 10 '. In parallel connector 920, the housing includes two holes 942 for bars 10, 10 '. Preferably, the bars 10, 10 'can move and slide through the holes 942. One or more set screws (not shown) may be provided to lock the position of any of the bars 10, 10 '. One or more cutouts 961 may be available that extend into the holes 942, enabling rods 10, 10 'to be laterally loaded. The cutouts 961 are preferably smaller than the diameter of the rods, whereby the rods can be latched into the holes 942 and held in the housing 965. The channel 983 can be formed to a significant extent around the side of the parallel connector 920, which is intended for a protective tape, such as, for example, a clamp. The securing tape 962 can secure the bars 10, 10 'in the holes 942, while allowing them to be displaced or moved in situ when the system is implanted in the patient's body. Parallel connectors advantageously support the parallel holding of rods, and away from each other, to promote and support easy sliding and telescopic operations.

[0063] Those skilled in the art will appreciate the ability to provide any or all of the elements described herein in kits or kits from which the surgeon can choose different combinations of elements to perform a stabilization procedure or to create a system configured specifically for the specific needs and anatomy of a patient. It should be noted that one or more copies of the item may be included in the set or set. In some sets and kits, the same device can be supplied in multiple copies and in various shapes and / or sizes.

[0064] The stabilization and guiding system is preferably provided to the user in a kit that may include (1) one or more elongated brackets, such as rods, for example; (2) one or more bone anchoring elements for securely fixing the longitudinal brackets to the bone (e.g. vertebra) preferably to form one or more anchoring points; (3) one or more lead connectors with bone connector parts and mechanisms; (4) one or more side connectors; and (5) one or more parallel connectors. [0065] Lead connectors may be pre-mounted and include one or more security elements, such as cable ties, tapes or cables. Lead connectors can be pre-mounted and loaded on the implant holder or to it and / or the drive tool. Lead connectors and rods can be made of any biocompatible material that is currently known or will be discovered in the future, such as, for example, titanium, titanium alloy, stainless steel, chromium-cobalt alloy, Nitinol, etc. Other materials, such as plastics, polymers , composites, ceramics and other materials currently known or that will be discovered later can also be used for lead fasteners and rods. The rods and lead connectors or parts thereof may be ground or coated with material to facilitate and favor the relative movement of the rods relative to the lead connectors.

[0066] Although the previous descriptions and drawings represent preferred embodiments of the present invention, it is understood that various additions, modifications, combinations and / or substitutions may be made to the invention without departing from the broad scope of the present invention defined by the appended claims. In particular for those skilled in the art, it is obvious that the present invention is not limited to the specific embodiments shown and described, but can be made in other specific forms, structures, systems, proportions and using other elements, materials, departing from the essence of the invention .

Appreciate the possibility of using the invention of functions and elements without or essential features. Those skilled in the art of engineering with modifications of structures, systems, proportions, with many materials, with the practice of functions and the invention, elements that are and otherwise in particular adapted to the specific environment and working requirements without departing from the assumptions of the present invention. In addition, the functions described herein can be used alone or in combination with other functions. Therefore, the currently disclosed embodiments should in all respects be considered as exemplary and non-limiting, where the scope of the invention is indicated by the appended claims and is not limited to the description given previously.

Synthes GmbH, Switzerland Representative:

EP 2 337 512 B1 Z-9502/12