WO2014088522A2

WO2014088522A2 - Ortovia spinal system

Info

Publication number: WO2014088522A2
Application number: PCT/TR2013/000367
Authority: WO
Inventors: Hacı KUTLU
Original assignee: Spi̇namer Sağlik Ürünleri̇ Sanayi̇ Ve Teknoloji̇ Li̇mi̇ted Şi̇rketi̇
Priority date: 2012-12-07
Filing date: 2013-12-09
Publication date: 2014-06-12
Also published as: WO2014088522A3

Abstract

The present invention relates to a spinal pedicle screw system, which can be available in two different types as monopoly and polyaxial in order to provide stability, simplicity and functionality, which is applied to the pedicle of the spine for correction, stabilization and fusion in the surgical treatments of spinal diseases.

Description

DESCRIPTION

Ortovia Spinal System

Technical Field

The present invention relates to a spinal screw system, which can be available in two different types as monopoly and polyaxial in order to provide stability, simplicity and functionality, which is applied into pedicle of the spine for correction, stabilization and fusion in the surgical treatments of spinal diseases.

State of the Art

In the surgical treatment of spinal diseases, transpedicular screws that are applied into pedicle of the spine for correction, stabilization and fusion purposes are used. These screws are connected to each other by means of sticks called as rod, and therefore the spine is corrected and stabilized.

Even though the pedicle screws were developed in 80s; they are still being widely used. Various properties have been added in time to these screws, the first examples of which are monoaxial, that is one-piece and static; and therefore their functions have been increased and the possible complications have been eliminated.

Firstly, in order to prevent the set screw from being removed from the screw, some systems have also been developed which hold the screw head from the outside. In relation to these systems, the utility model application numbered TR 200702547 can be considered as an example. The invention according to the present invention relates to a dinamic spine screw. In spine surgery, the lower part of the head part is formed in the shape of a split (U form) so as to provide the movement of the screw part to the two opposite direction, which is used in the surgeries conducted with non-fusion technique. The globe-formed top part of the screw is the dinamic spine screw which can apply contolled movement to the opposite two directions within the channel by means of a ring within the globe. The patent applications numbered PCT/TR2001/000024, US7780706, US8167913, US 8123284 can be considered as examples for these type of systems.

The systems that have been developed later are granted with a polyaxial property by means of the movable head part. Here the screw head and screw shaft are jointed with ball-bearing system and fixed at a desired angle with different methods and designs. The patents numbered US8167913, 2008/00141 , US8197517, US7955359, US 8123284 can be considered as examples for these type of systems.

In time, some improvements have been made on the characteristics of the grooves so that the used set screw does not leave from its place. The patents numbered US8167913, US6302888, US5697929, US7018378, US07377923 relate to the improvements recorded on the groove characteristics.

In the meanwhile, different screw shaft designs have been created so that the screw does not pull away from the bone. Moreover, cannula is added into the screw shaft so that the material can be added into the bone for treatment purposes. The application numbered with US 8197517 and registered to TPE with the number TR201001050 relates to the improvements recorded on screw shaft.

Again, in the state of the art, channels have been created for the shafts of the screw head in order to increase the angle between the screw head and shaft. The application registered to TPE with the number 2008/00141 and the patent application with the publication number of EP2505157 A1 relate to the channels created on the shaft.

In addition to this, various surface processes have already been tried in order for the screw shafts to be integrated to the bone. Patent application numbered US 8197517 relates to such types of surface processes.

In some of the current spinal systems, some channels are created on the base of screw head, especially in medial-lateral direction so that the angle between the joint, namely the shaft and the screw head can be increased. This causes an extra insufficiency in the system because of the decrease in holding surface of the joint and the flexibility of ball-bearing channel. The more this angle increases, the more the level of insufficiency of the joint increases, which causes correction losses. In some of the screws, there is the risk of screws to pull away from the screw head. The application numbered 2008/00141 bears such type of a risk.

Currently, the above-mentioned movable polyaxial screws are preferred and widely used, which have different characteristics. However, the complications and functional insufficiency of these systems are still subsisting. Besides that, each new design brings about new disadvantages and complications, which results in needs for new designs.

Therefore, a more stable, functional and practical system is needed, which will eliminate the complications and disadvantages of the current systems.

As the spine is a very sensitive and risky zone, some aspects such as easy-applicability, modularity, functionality, simplicity, low-profile property, stability and safety are the desired features in an ideal screw system.

Object of the Invention

The main object of the present invention, in order to eliminate the disadvantages of the current systems, is to develop a spinal screw system which can be available in two different types as monopoly and polyaxial in order to provide stability, simplicity and functionality, which is applied to the pedicle of the spine for correction, stabilization and fusion in the surgical treatments of spinal diseases.

Another object of the present invention is to disclose a configuration which has the features such as easy- applicability, modularity, functionality, simplicity, being low-profile, stability and security in the spinal screw systems according to the present invention, as the spine is a very sensitive and risky zone.

So as to achieve said objects, the present invention relates to a spinal screw system which is applied to the pedicle of the spine for correction, stabilization and fusion in the surgical treatments of spinal diseases; which can be available in two different types as monopoly and polyaxial in order to provide stability, simplicity and functionality; which comprises a screw head, a screw shaft connected with said screw head in a way that it can make angular movement and a set screw fixing the rod compressing on said screw shaft; characterized in that the screw shaft can move 360 degree in any direction inside the screw head; the rod inside the screw head fixes the screw shaft by pressing on the global head of the screw shaft when the set screw is tightened at a desired angle; the global bearing of the screw head is comparatively smaller than the global head of the screw shaft.

In a preferred embodiment of the present invention, the channel inlet where the rod fits on the scew head is narrower than the channel base; the rod is kept within its bearing after a "click" sound is heard from the relatively narrow place while the rod is being fitted; and therefore the set screw application is conducted.

In a preferred embodiment of the present invention, the outer surface of the top of the screw head is dented and the outer side surface of the screw head is in the shape of an inclined ramp decreasing towards the dent.

In a preferred embodiment of the present invention, the head of screw shaft can be fitted with a "click" sound into the shaft bearing after passing through a relatively narrow place, and be removed similarly.

In a preferred embodiment of the present invention, a groove is created at the side part of the screw head base, the angling increases up to 45 degrees after the shaft goes into said groove while it is being angled in order to increase angling.

In a preferred embodiment of the present invention, the shapes of the set screw groove and the grooves of the screw head are square; the grooves pose a 90-degree angle with the screw shaft and they are in a trapezoid form.

In a preferred embodiment of the present invention, the screw shaft head has a global shape, the side parts of the 40% of the upper globe are in a square shape, and its top is global (figure 7).

In a preferred embodiment of the present invention, the screw shaft head is conical, the side parts of the 40% of the upper globe are square, its top is flat (figure 8); when applied with the screw head, it is movable and angled when the set screw is loose, and it gains the features of monoaxial screw when the set screw is fastened.

In a preferred embodiment of the present invention, the inner part of the screw shaft is cannulated, there are two longitudinal channels which are thoroughly connected with the cannule that is located inside with a 180- degree to each other at the end of the shaft; the channel is connected with the split created towards the end for self-taping purpose; the part of 3-5 mm without grooves which is available at the end part of the shaft does not have any channel (figure 9). In a preferred embodiment of the present invention (called monopoly), the spinal screw system is movable when the set screw is loose, and monoaxial and neutral when the set screw is fastened.

In a preferred embodiment of the present invention, the groove structure of the screw shaft is in a trapezoid form, and the threads are located with a 90-degree angle to the shaft.

In a preferred embodiment of the present invention, the double surface of the rod is made flat at 180 degree.

In a preferred embodiment of the present invention, the rod is fixed with transverse binders, the clips and plates binding these clips which are created on the transverse binder are used for the fixing process; the clipses grab the rod with a "click" sound; the transverse binder comprises rod-holding legs having a circular bearings more than a semi-circle; it fixes both the plate and the rod-holding heads by holding the rod firmly when the set screw is fasted and the set screw channel is opened (by means of a mechanism similar to the opposite side of a scissor), respectively.

In a preferred embodiment of the present invention, the end part of the plate is in a global form, and it can be fixed at different angles polyaxially.

Figures for a Better Understanding of the Invention

Figure 1 is the front view of the spinal screw system.

Figure 2, is the exploded view of the spinal screw system.

Figure 3, is the front view of the spinal screw system when the screw is angled.

Figure 4, is the perspective view of the screw head.

Figure 5, is the perspective view of the screw head.

Figure 6, is the perspective view of the screw head.

Figure 7, is the side view of the polyaxial screw shaft.

Figure 8, is the side view of the monopoly screw shaft.

Figure 9, is the side view of the cannulated screw shaft.

Figure 10a, is the side view of the set screw.

Figure 10b, is the sectional side (A-A) view of the set screw.

Figure 1 1 a, is the front view of the double flattened rod.

Figure 1 1 b, is the side view of the rod.

Figure 12, is the general perspective view of the spinal screw system when it is mounted.

Figure 13, is the side view of the spinal screw system when it is demounted.

Figure 14, is the side view of the spinal screw system when it is demounted.

Figure 15a, is the side view of the screw shaft.

Figure 15b, is the side sectional view (B-B) of the screw shaft.

Figure 16, is the perspective view of the screw shaft having a global head.

Figure 17, is the perspective view of the screw shaft with channels-cannules.

Figure 18, is the perspective view of the set screw.

Figure 19, is the perspective view of the transverse binder.

Figure 20, is the perspective view of the plate. Figure 21 , is the perspective view of the rod

Reference Numbers

1. Spinal screw system

2. Screw head

2.1. Channel inlet

2.2. Channel base

2.2.1. Groove

2.3. Dent

2.4. Outer side surface

2.5. Global bearing

2.6. Vertical groove

3. Screw Shaft

3.1. Shaft head

3.2. Channel

3.3. Polyaxial shaft head

3.4. Monopoly shaft head

3.5. Shaft Channel

4. Set screw

5. Rod

6. Transverse binder

6.1. Rod-holding leg

6.2. Set screw channel

6.3.Clips

7. Plate

Detailed Decsription of the Invention

The present invention relates to a spinal screw system (1 ), which can be available in two different types as monopoly and polyaxial additionally with cannulated shaft options (Figure 9) in order to provide stability, simplicity and functionality, which is applied to the pedicle of the spine for correction, stabilization and fusion in the surgical treatments of spinal diseases.

Spinal screw system (1 ) according to the present invention has two types as monopoly and poliaxial because of need for stability, simplicity and functionality (Figure 1, Figure 2, Figure 3, Figure 7, Figure 8).

The spinal screw system (1) is a simple and modular system which is composed of three parts as screw head (2), screw shaft (3) and set screw (4). In Figure 4, 5 and 6, the perspective views of the screw head (2) are provided. In Figure 7, 8 and 9, the perspective views of the screw shafts (3) are given. In Figure 10a and 10b, on the other hand, the detailed views of the set screw (4) are provided. Screw Head;

The screw head (2) has a global housing (2.5) where screw shaft (3) fixes the globe head (3.1 ) and the shaft head (3.1 ) makes polyaxial movement. This housing has a global form, and different from its similars, the globe diameter (2.5) is relatively smaller than that of the shaft head (3.1). In the spinal screw system according to the present invention, the set screw (4) presses on the rod (5) (Figure 1 a-1 l b), and the rod (5) directly presses on the shaft head (3.1 ) (Figure 1 , Figure 12). In this Figure, as the shaft head (3.1 ) is put into a global housing which is relatively narrower than its own diameter, it is squeezed and therefore fixed at a desired angle in a secure way. When the set screw (4) is unfastened, the joint is moved.

In order to provide ease of usage in the spinal screw system (1) according to the present invention, new designs have been made on the screw head (2). The channel inlet (2.1 ) in which the rod (5) is fitted on the screw head (2) is relativey narrower than the channel base (2.2); and the rod (5) passes through a relatively narrow place with a "click" sound while it is being fitted on the screw; and it provides the set screw (4) application to be easier by keeping the rod (5) in its housing (Figure 14).

Moreover, the top of the screw head (2) has a dented (2.3) form, and its outer side surfaces (2.4) are inclined towards the dent (2.3) (Figure 14). Thanks to this dent-slide system, the screw head (2) can easily be held by means of the screw persuader, and therefore the rod (5) can easily be fitted on the screw and set screw can easily be applied.

Again for modularity, mounting and ease of production purposes, the screw shaft head (3.1 ) is fitted on its housing (2.5) with a "click" sound by passing through a relatively narrow place. And it can be removed in the same way.

The screw head (2) has a simple structure, and has a lower profile comparatively.

The screw heads (2) are modular and polyaxial; and there are three separate screw heads (2) for functionality and stability (Figure 4, Figure 5, Figure 6).

Normoflex screw head (Figure 4): The polyaxial screw head (2) is movable 360 degrees, and has a polyaxial feature of 0-30 degrees. It has a pretty stable joint feature, and is a secure system in terms of correction loss. In the configurations where stability comes to the forefront, normaflex polyaxial screws should be preferred.

Hyperflex screw head: In the hyperflex screw system, a vertical groove is created on the side wall of the screw base (2.6), having the shaft neck diameter and connected with the outlet channel of the screw shaft (3) and with a limited depth in a way that it will affect the stability of the system at a minimum level. Moreover, this process provides an easy production, as well. Therefore the angling increases up to 45 degrees.

Hyperflex S (Figure 6): Medio-lateral hyperflex (hyperflex S) is obtained by means of the groove (2.6) created on the side part of the screw head base (2.2) for medial or lateral angling. Hyperflex F (Figure 5): It is obtained by means of the groove (2.6) created on the cranial or caudal part of the screw head base (2.2). When cranial or caudal forward angling is desired, hyperflex F polyaxial screws should be preferred.

Monopoly screw: It is obtained by the combination of screw head (2) in Figure 4 and screw shaft with conical head (3.4) (Figure 8). The monopoly screws are movable and angled when the set screw (4) is loose; whereas they gain a monoaxial screw feature when the set screw (4) is fastened. If full-stability is desired, monopoly screws should be preferred.

Screw shaft:

The neck of the screw shaft (3) measuring 5mm does not have thread; and the shaft part is conical up to the end part. The thread thereon are in a trapezoid form, and the angle between the shaft and the thread is 90 degree. The 5-mm part at the end part of the shaft is conical and has a self taping feature (Figure 15a-15b).

The system has three different screw shafts (3) such as global-head (Figure 7, Figure 16), conical-head (Figure 8) and channeled-cannulated (Figure 9, Figure 17) in terms of stability and functionality.

Global-head screw shaft (Figure 7): The head of the screw shaft (3.1 ) is in the form of a globe. The side parts of the upper 40% of the globe are in a square shape, and its top is global. The remaining 60% part is global. Therefore, it can be screwed or removed easily by being held from its square part. When applied with the screw head, it can be movable and angled when the set screw is unfastened; and it can be fixed at desired angle, when the set screw is fastened. The spinal screw set is called polyaxial pedicle screw.

Conical-head screw shaft (Figure 8): The head (3.4) of the screw shaft (3) is conical, and the side parts of the upper 40% of the globe are square and have a flat top. When applied with the screw head, it can be movable and angled when the set screw is unfastened; and it gains the feature of a monoaxial screw when the set screw is fastened. This spinal screw set is called monopoly pedicle screw in present invention.

In present invention the screw shaft has a such screw structure that it prevents pulling away by means of square thread having 90-degree angle. And its neck is designed as thick for resistance (Figure 15a-15b). The screw shafts (3) are available in various diameters and lengths.

Channeled-cannulated screw shaft (Figure 9, Figure 17): There is a hole in the inside part of the screw shaft (3.5), and there is a canal (3.2) which is thoroughly connected with the hole inside that is located at 180 degree to each other on the shaft end. The channel (3.2) starts on the last 5-mm part of the end and its length is preferably of 10 mm. This channel is connected with a self-taping channel on the end. Therefore, as the bone cement given from the inner part of the shaft (3.5) can be easily discharged, the pressure of discharging will decrease, and thus the undesired cement leakage to the undesired parts will be prevented. Moreover, a longitudinal cement support will be created inside the corpus. The last 5-mm part of the screw does not have any hole, and in the case that the screw pierces the bone, the cement will be prevented from overflowing outside of the bone. Set screw:

The set screw (4) has square thread making 90-degree angle with the shaft and it is in a trapezoid form; and therefore a secure fixing can be conducted (Figure 10a-1 Ob).

The system is provided to the user in a demounted form, or optionally it can be presented after being combined. Therefore, it has a pretty simple and modular structure feature.

Spinal Rod:

As well as the normal cylindrical rods in the system, there are also double flattened rods (5) by flattening both surfaces at 180 degrees (Figure 11 a-11 b, Figure 21). Therefore a low profile screw can be provided; a gradual de-rotation can be provided with the rod (5) while the set screw (4) is being fastened; undesired rotation is prevented; and it becomes easy to hold and fix the rod (5).

Transverse Spinal Binder:

In the system, there is a transverse binder (6) which can be applied easy, which is practical and safe (Figure 19). This system is composed of clips (6.3), set screw (4) and plate (7). The clipses (6.3) have rod-holding legs (6.1 ) in the shape of cylindrical housing, more than a semi-circle, which grap the rod (5). By means of an anti-scissor mechanism, there is available a set screw channel (6.2) which can be opened when the set screw (4) on the end part is fastened. Here the clipses (6.3) press on the rod (5), and it is easily fitted with a "click" sound. The plate (7) and both of the clipses (6.3) are united. When the set screw (4) is fastened, both the plate (7) is fixed, and the rod (5) is holded by the rod legs after the set screw channel (6.2) opens. Therefore the system is completed.

The Process of the System:

By choosing a proper screw head (2) and shaft (3), the screw shaft (3) is mounted to the screw head (2) by "click" sound. The screw is applied into the pedicle of the spine by using screw-driver. The other screws are located in the same manner. By choosing the rods (5), screw-rod fixing is conducted. Therefore, the rod (5) is located on the screws with a "click" sound, and so the set screws (4) can easily be applied. Moreover, the transverse binders (6) are located on the rods (5) with a "click" sound as well. After connecting the transverse binders by the transverse plate (7), the set screws (4) are fastened. Lastly, all of the set screws (5) are fastened again with a torque meter and the process is completed.

Claims

1. A spinal screw system (1), which is applied to the pedicle of the spine in order to provide correction, stabilization and fusion in the surgeries of spine diseases and which can be available in two different types as monopoly and polyaxial in order to provide stability, simplicity and functionality; comprising; a screw head (2),

a screw shaft (3) connected with said screw head (2) in a way that it may make angular movement,

a set screw (4) which fixes a rod (5) pressing on said screw shaft (3); characterized in that the screw shaft (3) can move 360 degree in any direction inside the screw head (2); the rod (5) inside the screw head (2) fixes the screw shaft (3) by pressing on the shaft head

(3.1) of the screw shaft (3) when the set screw (4) is fastened at a desired angle;

the global bearing (2.5) of the screw head (2) is relatively smaller than the shaft head (3.1) of the screw shaft (3).

2. A spinal screw system (1 ) according to Claim 1 , characterized in that

- The channel inlet (2.1) of the screw head (2) is narrower than the channel base (2.2) where the rod (5) is fitted on the screw head (2),

- The rod (5) passes through a relatively narrow channel inlet with a "click" sound, and rod is kept to be fixed by set screw (4).

3. A spinal screw system (1 ) according to Claim 1 , characterized in that

- the top part of the screw head (2) is dented (2.3), and

- the outer side surface (2.4) of the screw head (2) is in the shape of an inclined ramp decreasing towards the dent (2.3).

4. A spinal screw system (1) according to Claim 1 , characterized in that the screw shaft (3) can be fitted on the global bearing (2.5) on the screw head (2) with a "click" sound by passing through a relatively narrow place.

5. A spinal screw system (1 ) according to Claim 1 , characterized in that

- a vertical groove (2.6) is created on the side part of the channel base (2.2), and

- the angling increases up to 45 degrees after the shaft (3) goes into said vertical groove (2.6) while it is being angled.

6. A spinal screw system (1 ) according to Claim 1 , characterized in that

- the set screw (4) threads and the coupling threads of the screw head (2) are both in square form,

- the threads form a 90-degree angle with the screw shaft (3) and they are in a trapezoid form.

7. A spinal screw system (1 ) according to Claim 1 , characterized in that

- the screw shaft head (3.1 ) has a global shape,

- the side part of the 40% of the upper globe is square and its top is global shaped.

8. A spinal screw system (1 ) according to Claim 1, characterized in that

- the screw shaft head (3.1 ) is conical,

- the side parts of the 40% of the upper globe are square and the top is flat, when applied with the screw head (2), it is movable and angled when the set screw (4) is unfastened, whereas it has a monoaxial screw feature when the set screw (4) is fastened.

9. A spinal screw system (1 ) according to Claim 1, characterized in that

- the inner part of the screw shaft (3) is cannulated,

- there are two longitudinal channels (3.2) which are thoroughly connected with the shaft channel (3.5), and are located at 180 degree to each other on the shaft (3) end,

- the 3-5 mm part on the end part of the shaft (3) does not have any channel.

10. A spinal screw system (1 ) according to Claim 1 , characterized in that

- the spinal screw system (1 ) is movable when the set screw (4) is unfastened; and it has the neutral and monoaxial feature when the set screw (4) is fastened.

11. A spinal screw system (1 ) according to Claim 1 , characterized in that the thread structure of the screw shaft (3) is in a trapezoid form, and the threads are located at 90 degree to the shaft.

12. A spinal screw system (1 ) according to Claim 1 , characterized in that both surfaces of the rod (5) are flattened at 180 degrees.

13. A spinal screw system (1 ) according to Claim 1 , characterized in that

- the rod (5) is fixed by means of transverse binders (6),

- clipses (6.3) that are formed on the transverse binder (6) for this fixing process, and the plates (7) binding these clipses are used,

- the clipses (6.3) grab the rod (5) with a "click" sound,

- the transverse binder (6) comprises rod-holding legs (6.1) having a circular housing, more than a semi- circle,

- when the set screw (4) is fastened, it fixes both the plate (7) and the rod (5) by holding the rod (5) tightly with the rod-holding legs (6.1) by opening the set screw channel (6.2) (with an anti-scissor mechanism).

14. A spinal screw system (1) according to Claim 1 , characterized in that the end part of the plate (7) has a global form, and it can be fixed polyaxially at different angles.