WO2020242422A1

WO2020242422A1 - Screw and plate system for reconstruction of cervical vertebral defects, which are caused by various reasons in different regions

Info

Publication number: WO2020242422A1
Application number: PCT/TR2020/050458
Authority: WO
Inventors: Unal OZUM; Bahadir KARACA; Mustafa CETIN; Fatih OZAYDIN; Aysen MAT
Original assignee: Estas Tibbi Mamulleri Medikal Cihazlar Otomotiv Imalat Ithalat Ihracat Ve Ticaret Sanayi Anonim Sirketi
Priority date: 2019-05-30
Filing date: 2020-05-27
Publication date: 2020-12-03
Also published as: TR201908268A2

Abstract

The invention is a posterior plate used in the reconstruction of cervical vertebral defects, which are caused by various reasons in different regions, and characterized in that including - at least one fixed hole (10.1, 30.1, 40.1) and / or at least one variable hole (10.2, 30.2, 40.2) that secures the posterior plate (10, 30, 40) to the occipital region, -at least one bending channel (10.3, 30.3, 40.3), which enables the bending and shaping of the posterior plate (10, 30, 40) according to the region to be applied and / or guides to be cut to the proper size, -a set screw hole (10.4, 30.4, 40.4), which allows the rod (20) to be tightened by clamping, -for ease of application, the rod channel (10.5, 30.5, 40.5), which contains the movement allowance where the length "h" is in the range of 1-2 mm and is used to connect the neck and the head.

Description

Screw and Plate System for Reconstruction of Cervical Vertebral Defects, Which Are Caused by Various Reasons in Different Regions

Technical Field The invention relates to screw and plate system groups for reconstruction of cervical vertebral defects, which are caused by various reasons in different regions.

Prior Art

In the prior art there are two types of plates, 4 and 6-hole plates. Plates are not produced in accordance with the direction of fracture. One-sided fixation can be done only on the fractured area. During the connection of the mentioned plates with the rod (cylindrical rod), itching occurs in the rod. That itch makes it very difficult to fix the rod on the plate. This situation not only creates difficulties for the physician but also may harm the patient.,

In the American patent coded US20150032161 in the prior art, an adjustable occipital plate is mentioned. The plate expressed in the mentioned document is a fixation plate, which includes at least one lateral rod configured to be coupled to said fixation plate, at least one laterally sliding link configured to be coupled to and configured to be compressed around said at least one lateral rod to create a friction fit, and at least one rod connector coupled to said at least one laterally sliding link that is configured to receive at least one posterior cervical rod.

The American patent coded US20080183217 in the prior art mentions the posterior vertebra locking plate. The plate expressed in said document includes a four-hole locking plate designed with four locking screw holes and two lateral variable angle screw heads for posterior vertebrae fixation.

In the American patent coded US20080183217 in the prior art, the occipital plate and rod system are mentioned. The system expressed in said document has a plate and rod assembly for implantation in the cervical region of the spine which includes an occipital plate having an angled anchor bridging area that is attached to the lower posterior curve of the skull. On either side the bridging area is connected to offset legs which join flanged areas that include tethered rod anchors having rod-receiving channels. Specifically, the flanged areas have a high friction surface, which is preferably knurled, to bite into the surface of the rod that is received in the channels. These flanges include undercut slots that capture the side plates integral to the open U-shaped members including the rod-receiving channels. The side plates extend longer in the direction of the longitudinal axis of the rod when it is in the channel. These side plates can thus be lowered into the slot and rotated by 90 degrees to capture the channels in the flanges since the undercut slots are not as wide as they are long. The channels are closed by a cap-nut which has a bottom annular flange that also helps to lock the rod in place. The angle of the rod-receiving flanges relative to the plate bridging area allows the rods to be positioned close to the cervical vertebrae so that they can also be attached to the cervical vertebrae using vertebral anchors. The cap-nut is self-aligning as it includes an internal projection that cooperates with the internal recess of the rod-receiving channel members in the direction of the longitudinal axis of the attachment screw. Further, the cap-nut includes a visual alignment cue that helps to inhibit cross threading by indicating the proper side for starting the cap-nut on the threads of the channel. Three debossed dots show the alignment relative to a similarly placed set of dots on the proper side of the rod-receiving channel.

The American patent coded US20080183217 in the prior art mentions the bone- screwed bearing system in the prior art. The system expressed in said document is configured as a bone screw retention system comprising an implant adapted to apply the anterior human cervical spine to contact the anterior aspects of the stem of the at least two cervical vertebrae and having a plate defining a number of transverse extending holes, and each hole is configured to receive a bone screw to attach the plate to the cervical spine.

In the US patent coded US20180310966 in the prior art, the anterior cervical plate is mentioned. The plate expressed in the said document is is configured to receive bone screws for attachment to and immobilization of adjacent vertebrae of the spine. The system includes a lock configured to prevent the bone screws from backing out of the plate. The lock includes at least one blocking surface that is movable between a blocked configuration preventing the bone screw from backing out and an unblocked configuration allowing passage of the bone screw. The lock achieves a blocked position in a rotation of less than 90 degrees while maintaining or increasing a low-profile.

In the US patent coded US20180185071 in the prior art, the anterior cervical plate is mentioned. The plate, expressed in said document, includes a retention ring with a deflectable flange that is upwardly spaced from the top surface of the ring and configured to prevent an inserted bone fastener from backing out of the plate. The plate includes a locking pin having a camming surface and a blocking surface. When the camming surface is moved into position adjacent to the flange, the flange is free to flex out of the way of a bone screw being inserted into or removed from the plate. When the blocking surface is positioned adjacent to the flange, outward deflection of the flange is prevented to retain the bone screw inside the plate. The locking pin is rotated through a camming surface to bring a blocking surface against the flange deflecting the flange onto the head of the bone screw.

Occipital and anterior plates used in the prior art are available in separate sets. However, there are approximately 31 types of separate hand tools in the set of occipital and anterior plate systems. Excessive number of hand tools not only delays fixing of the plaque system to the relevant part of the body but also makes it difficult. The composite plates in the prior art do not have a fixed rod connection. For this reason, moving occurs at the rod. In addition, when fixing the plates and screws to the relevant places, the fixing angles are unilateral so that they can hardly be fixed by the physician. However, the intervertebral region does not appear in the anterior plates currently used. Therefore, physicians have difficulty in determining the region where the plate will be fixed.

The screws used to fix the parts of the current plaque system are different for the occipital plaque and the anterior plaque. However, each screw can be fixed to the relevant place at a single angle. In addition, the plates and screws used do not contain antibacterial coating.

Purpose of the Invention

The object of the invention is to obtain a screw and plate system that can be easily applied to the relevant part of the body.

Another object of the invention is it obtain a screw and plate system that provides comfort to the patient.

Another object of the invention is to obtain a screw and plate system, in which the number of hand tools and products used during the operation are halved.

Another object of the invention is to obtain a screw and plate system designed in accordance with the fracture direction.

Another object of the invention is to obtain a screw and plate system where the intervertebral region can be easily seen.

Another object of the invention is to obtain a screw and plate system in which the risk of infection is minimized. Screw and plate system for reconstruction of cervical vertebral defects, which are caused by various reasons in different regions, that was developed to realize these objects include

at least one fixed hole (10.1, 30.1, 40.1) and / or at least one variable hole (10.2, 30.2, 40.2) that secures the posterior plate (10, 30, 40) to the occipital region,

at least one bending channel (10.3, 30.3, 40.3), which enables the bending and shaping of the posterior plate (10, 30, 40) according to the region to be applied and / or guides to be cut to the appropriate size,

a set screw hole (10.4, 30.4, 40.4), which allows the rod (20) to be tightened by clamping,

a rod channel (10.5, 30.5, 40.5) which contains the movement share in which the“h” length is in the range of 1-2 mm for ease of application and used to connect the neck and the head.

Description of Figures

The figures are presented in the appendix.

Figure-1 is a front view of the composite plate (10).

Figure-2 is a front perspective view of the composite plate (10).

Figure-3 is a side perspective view of the composite plate (10).

Figure-4 is the bottom view of the composite plate (10).

Figure-5 is the front view of the composite plate (10).

Figure-6 is a cross-sectional view of the composite plate (10).

Figure-7 is the bottom view of the composite plate (10).

Figure-8 is a front perspective view of the right plate (30).

Figure-9 is the front perspective view of the left plate (40).

Figure- 10 is a perspective view of the exploded single window anterior plate (70). Figure- 11 is a top view of the single window anterior plate (70).

Figure- 12 is a top view of the double windows anterior plate (80).

The main parts expressed in the figures are given below as numbers and names. (10) Composite plate (10.1) Fixed hole

(10.2) Variable hole

(10.3) Bending channel

(10.4) Set screw hole

(10.5) Rod channel (20) Rod

(20.1) Nut-cap

(20.2) Set screw plane (30) Right plate

(30.1) Fixed hole

(30.2) Variable hole

(30.3) Bending channel

(30.4) Set screw hole

(30.5) Rod channel (40) Left plate

(40.1) Fixed hole

(40.2) Variable hole

(40.3) Bending channel

(40.4) Set screw hole

(40.5) Rod channel (50) Set screw

(60) Posterior plate screw

(70) Single window anterior plate

(70.1) Anterior screw hole

(70.2) Fixing screw hole

(70.3) Window

(70.4) Bending channel (80) Double window anterior plate

(80.1) Anterior screw hole

(80.2) Fixing screw hole

(80.3) Window

(80.4) Bending channel (90) Anterior plate screw

(100) Fixing screw

Detailed Description of the Invention

The invention relates to screw and plate system groups for reconstruction of cervical vertebral defects, which are caused by various reasons in different regions. System of the invention includes composite plate (10), rod (20), right plate (30), left plate (40), set screw (50), posterior plate screw (60), fixing screw (100), anterior plate screw (90), single window anterior plate (70) and double window anterior plate (80).

Anterior plate (70, 80) is the plate placed in the cervical vertebrae by opening an incision from the front of the neck. The posterior plate (10, 30, 40) is the plate placed in the occipital bone by opening the incision from the back of the neck. Anterior plate (70, 80) and posterior (occipital) plate (10, 30, 40) are not used at the same time. However, anterior plate (70,80) and posterior plate (10, 30, 40) are combined and given as a set to reduce the number of hand tools to half.

On the composite plate (10), there are fixed hole (10.1), variable hole (10.2), bending channel (10.3), set screw hole (10.4) and rod channel (10.5). The number of variable holes (10.2) on the composite plate (10) can vary depending on the need. There is a fixed hole (30.1), variable hole (30.2), bending channel (30.3), set screw hole (30.4) and rod channel (30.5) on the right plate (30). The number of variable holes (30.2) on the right plate (30) can vary depending on the need.

There is a fixed hole (40.1), variable hole (40.2), bending channel (40.3), set screw hole (40.4) and rod channel (40.5) on the left plate (40). The number of variable holes (40.2) on the left plate (40) can vary depending on the need.

The number and dimensions of the holes in the composite plate (10), right plate (30) and left plate (40) provide the physician with an easy fixing. In addition, the number of holes and dimensions mentioned are such that they increase the fractured region adhesion. Plates (10, 30, 40) contain 2, 3, 4 and 6 variable holes (10.2, 30.2, 40.2) for optimum benefit. In alternative embodiments of the invention, variable holes (10.2, 30.2, 40.2) can also be found in different numbers. Plates (10, 30, 40) are fixed with posterior plate screw (60) to the relevant part of the body through variable holes (10.2, 30.2, 40.2) and fixed holes (10.1, 30.1, 40.1). Posterior plate screws (60) are 03.5 mm and 5-25 mm long cortical screws. Said posterior plate screw (60) is produced from Ti6A14V Grade ELI material by the machining method.

There are bending channels (10.3, 30.3, 40.3) that allow the composite plate (10), right plate (30) and left plate (40) to be shaped easily. It provides the bending channels (10.3, 30.3, 40.3) and the plate (10, 20, 30) to be bent and shaped as the physician deems appropriate for fixing it to the region to be applied. Furthermore, the bending channels (10.3, 30.3, 40.3) also guide the said plates (10, 20, 30) to be cut to their proper size.

In the fracture region where the composite plate (10) is large, instead of placing multiple one-hole plates in the region, right plate (30) and / or left plate (40) can be used in accordance with the fracture direction. However, the number of holes of said right plate (30) and / or left plate (40) should be chosen in accordance with the location of the fracture. Thus, the fracture region can be fixed without using multi part plates.

Rods (20) to be placed in the rod channel (10.5, 30.5, 40.5) connect the spinal system screws placed on the spine and the plates to be placed in the cervical region. While connecting the spinal system screws and cervical plates, they may not be on the same axis. Plates can be varied on the right and left, higher and lower. The difference of the location of the cervical plates creates difficulties for the physician in connecting them with the spinal system. To this end, the "h" length of movement allowance has been left in the rod canals (10.5, 30.5, 40.5), which are used to connect the neck and head design, and to provide ease of application to the physician. Movement allowance provides ease of application to the physician and comfort to the patient by removing the itching in the rod channel (10.5, 30.5 40.5) and / or rod (20). The preferred value of the said movement allowance, which is "h", is ± 1.5 mm. In alternative embodiments of the invention, the value of "h" may vary depending on the thickness of the rod (20) used.

Screws and plates used in the vertebrae are the products with the highest risk of infection. These products cause infection in the patient after use and cause discharge in the patient. In order to prevent said infection, antibacterial coating is applied to the plates (10, 30, 40). Thus, the patient's comfort is provided by reducing the possible infection in the patient.

The composite plate (10), the right plate (30) and / or the left plates (40) are first fixed in the occipital bone by opening the incision from the posterior or anterior region. After fixing, the rods (20) are placed in the rod channels (10.5, 30.5, 40.5) located on the plates (10, 30, 40). After the rod (20) connection is made, the screws are fixed on the plates to ensure fracture stability.

The rod (20) is placed in the rod channel (10.5, 30.5, 40.5) on the plate (10, 30, 40) and then is fixed by tightening with the set screw (50). On the rod (20) there is a set screw plane (20.2). Said plane ensures that the rod (20) is firmly compressed without slipping the set screw (50) over the rod (20).

There is a nut-cap (20.1) for clamping on both ends of the rod (20). Said nut-cap (20.1) and rod (20) connect the screws of the spinal system located on the cervical plates and the spine.

The set screw hole (10.4) on the composite plate (10) is positioned at a certain angle for convenience to the physician. While fixing the screws, the physician works within the surgical region and away from soft tissues and the clamping screw axis angle can be used towards the skull and the centre. Said angles are shown with the letters“a, b, c, d, f” on Figure-5, Figure-6 and Figure-7. Said angles are between these intervals: a = 100.71° - 123.09°, b = 19.71° - 24.09°, c = 36° - 45.4°, d = 39.51° -53.69°, e = 103.5° - 126.5°, f = 22.5° - 27.5°. The optimum values of the mentioned angles are as follows: a = 111.9°, b = 21.9°, c = 40.7°, d = 49.3°, e = 115°, f = 25°. In alternative embodiments of the invention, the angles mentioned can vary.

The anterior plates (70, 80) and posterior plates (10, 30 40) used in the invention are presented as a single set. Said set is named as cervical region plates. In the set, the same screws (60, 90) are used for the anterior plates (70, 80) and posterior plates (10, 30, 40). In this way, the number of hand tools and plate screws (60, 90) used in the set is halved.

The posterior plate screw (60) used in posterior plates (10, 30, 40) can be sent at different angles to the holes (10.1, 10.2, 30.1, 30.2, 40.1, 40.2) via the chamfers in the holes (10.1, 10.2, 30.1, 30.1, 30.2, 40.1, 40.2). Considering the vertical, i.e. the Y-axis, said holes (10.1, 10.2, 30.1, 30.2, 40.1, 40.2) include chamfers or curved chamfers that expand the holes (10.1, 10.2, 30.1, 30.2, 40.1, 40.2) themselves from centre to the sides of the said Y axis, i.e. in the direction of + Z and -Z. The chamfered holes are clearly shown in Figure-6. By holding the posterior plate screw (60) at different angles, a better adhesion to the body is provided. Moreover, the fact that the posterior plate screw (60) can be sent at different angles provides ease of application to the physician. The screws and caps used in alternative embodiments of the invention may be different.

Anterior plates (70, 80) are plates placed in the vertebrae by making an incision through the anterior part of the neck. Anterior plates (70, 80) are of two types, single window anterior plate (70) and double window anterior plate (80). For easy viewing of the neck vertebrae, there is a single window (70.3) in the single window anterior plate (70), and two windows (80.3) in the double window anterior plate (80). In this way, the regions between the vertebrae can be easily seen. Thanks to the view of the area between the vertebrae, the physician can easily fix it. On the single window anterior plate (70), there are anterior screw hole (70.1), fixing screw hole (70.2), window (70.3) and bending channels (70.4). The single window anterior plate (70) is fixed to the relevant part of the body with the anterior plate screw (90). After said fixing process is completed, fixing screws (100) and anterior plate screws (90) are locked together.

On the double window anterior plate (80), there are anterior screw hole (80.1), fixing screw hole (80.2), windows (80.3) and bending channels (80.4). The double window anterior plate (80) is fixed to the relevant part of the body with the anterior plate screw (90). After said fixing process is completed, fixing screws (100) and anterior plate screws (90) are locked together. The anterior screw holes (70.1, 80.1) on the right and left of the windows (70.3, 80.3) on the anterior plates (70, 80) can be 17, 20 and 23 mm apart. The wall thickness of the anterior plates (70,80) is 3 mm. Anterior plate screws (90) and posterior plate (occipital plate) screws (60) have the same properties. Anterior plates (70, 80) are placed in the vertebrae by opening the incision from the front of the neck and fixed to the vertebrae with the anterior plate screws (90).

In order to shape the anterior plate (70, 80), bending channels (70.4, 80.4) are left on it. The bending channels (70.4, 80.4) and the anterior plate (70, 80) allow the said anterior plate (70, 80) to be shaped so that it can be fixed to the area to be applied as the physician deems it appropriate. However, the bending channels (70.4, 80.4) also guide the said anterior plate (70, 80) to be cut to the proper size.

The anterior plate screw (90) used in the anterior plates (70, 80) can be sent to said holes (70.1, 70.2, 80.1, 80.2) at different angles, thanks to the chamfers located in the holes (70.1, 70.2, 80.1, 80.2). Considering the vertical, i.e. the Y-axis, said holes (70.1, 70.2, 80.1, 80.2) include chamfers or curved chamfers that expand the holes (70.1, 70.2, 80.1, 80.2) themselves from centre to the sides of the said Y axis, i.e. in the direction of + Z and -Z. The anterior plate screw (90) can be sent at different angles, resulting in a better grip on the body. In addition, the fact that the anterior plate screw (90) can be sent at different angles provides ease of application to the physician. The screws and caps used in alternative embodiments of the invention may be different.

Posterior plates used in to screw and plate system for reconstruction of cervical vertebral defects, which are caused by various reasons in different regions, are produced by machining with a wall thickness of 2-mm TI6A14V Grade ELI material. The thickness of the anterior plates is 3 mm. There are bending channels (10.3, 30.3, 40.3, 70.4, 80.4) on the plates (10, 30, 40, 70, 80). Plates and other products are coated with anodic oxidation. Since the plates (10, 30, 40, 70, 80) and other products are spinal system products, the risk of infection is high. For this reason, antibacterial properties are gained by applying chitosan coating on the products. In alternative embodiments of the invention, the thicknesses and dimensions of the plates (10, 30, 40, 70, 80) can vary.

The invention is the posterior plate (10, 30, 40) used in the reconstruction of cervical vertebral defects, which are caused by various reasons in different regions; and characterised in that including at least one fixed hole (10.1, 30.1, 40.1) and / or at least one variable hole (10.2, 30.2, 40.2), which secures the posterior plate (10, 30, 40) to the occipital region, the posterior plate (10, 30, 40) at least one bending channel (10.3, 30.3, 40.3), which provides bending and shaping according to the region to be applied and / or cuts to the appropriate size by cutting, set screw hole (10.4, 30.4, 40.4), which allows the rod (20) to be fixed by tightening, and the rod channel (10.5, 30.5, 40.5), which contains the movement allowance in which the length "h" is in the range of 1-2 mm for ease of application and is used to connect the neck and the head.

Claims

C L A I M S

1. The invention is a posterior plate used in the reconstruction of cervical vertebral defects, which are caused by various reasons in different regions, and characterized in that; including

- at least one bending channel (10.3, 30.3, 40.3), which enables the bending and shaping of the posterior plate (10, 30, 40) according to the region to be applied and / or guides to be cut to the proper size, a set screw hole (10.4, 30.4, 40.4), which allows the rod (20) to be tightened by clamping,

- for ease of application, the rod channel (10.5, 30.5, 40.5), which contains the movement allowance where the length“h” is in the range of 1-2 mm and is used to connect the neck and the head.

2. The posterior plate mentioned in Claim 1 is characterized in that; including right plate (30) and / or left plate (40), which can be used in accordance with the direction of fracture, instead of placing multiple one-hole plates in the regions where the composite plate (10) is large.

3. The movement allowance mentioned in Claim 1 is characterized in that; in the preferred embodiment of the invention, the length of "h" is 1.5 mm.

4. Rod (20) mentioned in Claim 1 is characterized in that; including the set screw plane (20.2) that allows the rod (20) to be compressed without the set screw (50) slipping over the said rod (20).

5. Rod (20) mentioned in Claim 1 is characterized in that; including a nut-cap (20.1) which connects the cervical plates and the spinal system screws on the spine and is located at least one end of the said rod (20).

6. The set screw hole (10.4, 30.4, 40.4) mentioned in Claim 1 is characterized in that; allowing operation within the surgical area and away from soft tissues and for ease of application, positioning in the angle range of a = 100.71° - 123.09°, b = 19.71° - 24.09°, c = 36° - 45.4°, d = 39.51° -53.69°, e = 103.5° - 126.5°, f = 22.5° - 27.5°.

7. Set screw hole (10.4, 30.4, 40.4) mentioned in Claim 1 is characterized in that; allowing operation within the surgical area and away from soft tissues and positioning at the optimum angle values a = 111.9°, b = 21.9°, c = 40.7°, d = 49.3°, e = 115°, f = 25°.

8. Fixed hole (10.1, 30.1, 40.2) and variable hole (10.2, 30.2, 40.2) mentioned in Claim 1 are characterized in that; including chamfers or curved chamfers, considering the vertical axis, i.e. Y axis, that expand the holes (10.1, 10.2, 30.1, 30.2, 40.1, 40.2) themselves from centre to the sides of the said Y axis, i.e. in the direction of + Z and -Z.

9. Posterior plate screw (60) mentioned in Claim 7 is characterized in that; production from Ti6A14V Grade ELI material by machining method and being a cortical screw with 03.5mm diameter and 5-25mm length.

10. Posterior (10, 30, 40) mentioned in any one of the above claims and is characterized in that; including an anodic oxidation and chitosan coating to prevent possible infection or to minimize the risk of infection.

11. Plate system as claimed in any one of the above claims and is characterized in that; being a set of the posterior plate (10, 30, 40) and the anterior plate (70, 80).