WO2016043676A1

WO2016043676A1 - A pedicle screw with warning system

Info

Publication number: WO2016043676A1
Application number: PCT/TR2015/000170
Authority: WO
Inventors: Sezgin YILMAZ
Original assignee: Efmed Kesi̇ci̇ Takimlar Hirdavat Tibbi̇ Aletler Sanayi̇ Ve Ti̇caret Li̇mi̇ted Şi̇rketi̇
Priority date: 2014-09-16
Filing date: 2015-04-22
Publication date: 2016-03-24

Abstract

The present invention relates to a pedicle screw (1) which is inserted into bones in spinal operations and gives warning by measuring in what type of tissue the surgeon proceeds during the operation, essentially characterized by: at least one outer body (2); at least one insulation layer (3) which is located on the outer body (2) and provides electrical insulation; at least one conductive end (4) which is located inside the body (2) and has electrical charge in preferred pole.

Description

DESCRIPTION

A PEDICLE SCREW WITH WARNING SYSTEM

Technical Field

The present invention relates to a pedicle screw with warning system which is inserted into vertebra in spinal operations and gives audio and visual information to the surgeon about the place where it is situated inside the vertebra during surgical operation.

Background of the Invention Today, spinal operations are performed intensely. Objective of most of spinal operations is to balance the load applied to spinal cords. A screw or screws called as pedicle screw is or are fixed to the vertebra in most of these operations performed. These operations are performed entirely by means of surgical intervention. The surgeon determines the place where the screw will be fixed and then inserts the screw into vertebra by screwing after it passes through the pedicle. It is of prime importance that the pedicle screw is inserted to right place inside vertebra, it only corresponds to bone during placement and does not contact any tissue or muscle except bone during this surgical intervention. Performing all this surgical intervention in the best and correct way depends on experience and skill of the surgeon. Inserting the screw exactly into the right part of the bone and contacting it with no tissue except the bone during operation depends on experience of the surgeon. The more experienced the surgeon is, the more successfully and correctly the operation is performed. There is no system which automatically measures how correctly the pedicle screw, which is inserted into the bone of the patient, is placed; whether it corresponds to any tissue except the bone during spinal operations and gives the surgeon warning in the event of an undesirable condition. These conditions directly affect success rate in these types of operations. Operations performed by experienced surgeons are more successful, possibility of making a mistake is higher for surgeons who have received education recently or have the deficiency of imaging device.

No pedicle screw is available for giving surgeons warning and leading them in respect of where exactly the pedicle screw, which is inserted by the surgeon, is placed and whether the said screw proceeds inside the vertebra or on a different tissue in the state of the art.

Short Description and Objects of the Invention An objective of the present invention is to realize a pedicle screw which has a warning system that gives audio, light and visual warning to the surgeon about the tissue where s/he is located while fitting it into the bone.

Another objective of the present invention is to realize a pedicle screw which has a warning system that can recognize the tissue where it is located according to its resistance.

Another objective of the present invention is to realize a pedicle screw which has a warning system that guides the surgeon during spinal operations.

Detailed Description of the Invention

"A pedicle screw with warning system" realized to fulfill the objectives of the present invention is shown in the figures attached, in which:

Figure 1 is a schematic view of the pedicle screw with warning system. Figure 2 is a cross-sectional view of the pedicle screw with warning system.

Figure 3 is a schematic view of the pedicle screw with warning system.

The components illustrated in the figures are individually numbered, where the numbers refer to the following:

1. Pedicle screw

2. Outer body

21. Head

22. Connection point

3. Insulation layer

4. Conductive end

41. Connection point

5. Battery

6. Control box

7. Connection member

8. Warning indicator

The pedicle screw (1) which is inserted into the vertebrae in spinal operations and gives warning by measuring in what type of tissue the surgeon proceeds during the operation essentially comprises:

- at least one outer body (2);

- at least one insulation layer (3) which is located on the outer body (2) and provides electrical insulation;

- at least one conductive end (4) which is located inside the body (2) and has electrical charge in preferred pole.

The outer body (2) is located on the outermost surface of the inventive pedicle screw (1). The outer body (2) is preferably coated with threads which will enable insertion into bone. The head (21 ) is located on the upper part of the body (2). On the head (21), there is preferably slot which will enable rotation of the pedicle screw (1). The pedicle screw (1) is moved in a forward and backward direction inside the bone upon being rotated by means of a tightening apparatus placed inside the slot. Tightening and rotating the pedicle screw (1) is carried out by means of the slot located on the head (21). The user enables the screw (1) to proceed inside the bone by tightening the head (21) through tightening gun or manually. The head (21) part is preferably protruding and circular. The head (21) can be formed such that it can be angled independently of the body (2). The body (2) has electrical conductivity and on the body (2), there is at least one connection point (22) where the preferred electrical charge (+ or -) can be connected on the body (2). The body (2) is charged with the electrical charge that it receives over the connection point (22). In a preferred embodiment of the invention, the body (2) is charged with positive (+) or negative (-) electrical charge.

Interior of the body (2) has a hollow structure and inner surface of the body (2) is coated with insulation material. Thus, an insulation layer (3) is formed in the inner surface of the body (2). The insulation layer (3) is preferably made of a material having no electrical conductivity and it provides electrical insulation. Different materials can be used as insulation layer (3). In a preferred embodiment of the invention, the insulation layer (3) made of insulation materials.

The insulation layer (3) and the conductive end (4) are located in the gap existing in the inner surface of the body (2). The conductive end (4) can be along the whole body (2) and it can also be shorter than the body (2). In a preferred embodiment of the invention, the conductive end (4) is along the whole body (2). The conductive end (4) has conductive characteristic. On the conductive end (4), there is at least one connection point (41) where the preferred electrical charge (+ or -) can be connected. In a preferred embodiment of the invention, the conductive end (4) is charged with positive (+) or negative (-) electrical charge. The conductive end (4) is charged with electrical charge (+ and -) in the pole received from the connection point (41). The battery (5) provides electrical charge for the body (2) and the conductive end

(4) . The connection point (22) located on the body (2) and the connection point (41) located on the conductive end (4) are connected to the poles of the battery

(5) . Thus, the battery (5) charges the connection points (22, 41) such that one of them is (+) and the other is (-) when it is activated.

In a preferred embodiment of the invention, there is at least one control box (6). The control box (6) is located in the head (21) on the body (2). In an alternative embodiment of the invention, the control box (6) is located independently of the screw (1). The battery (5) is preferably located inside the control box (6). The control box (6) is preferably fixed onto the pedicle screw (1) by the connection member (7). The connection member (7) is in the form of lug, clips, welding, etc.

In a preferred embodiment of the invention, there is at least one warning indicator (8) on the control box (6). The warning indicator (8) gives audio, light and visual warning. The warning indicator (8) operates according to the electrical resistance measured by the body (2) and the conductive end (4). When the electrical resistance read from the body (2) and the conductive end (4) differs by the electrical resistance measured in the bone, the warning indicator (8) is automatically activated and it gives audio, light and visual warning to the surgeon.

In a preferred embodiment of the invention, the battery (S) is connected to the body (2) and the conductive end (4) by means of the connection points (22, 41). Thus, the battery (5), the body (2) and the conductive end (4) are charged with electrical charge in preferred pole. During surgical operation, the body (2) and the conductive end (4) are inserted into the bone. When the operation is started, an electrical charge is read between the body (2) and the conductive end (4). The electrical charge read is transmitted to the control box (6) continuously. When the pedicle screw (1) is being inserted into the bone, it measures an electrical charge according to the tissue where the body (2) and the conductive end (4) contact. When the tissue contacted by the body (2) and the conductive end (4) changes, in other words when any tissue except the bone is contacted, the electrical resistance at that surface changes. The body (2) and the conductive end (4) read the resistance change. When the control box (6) finds out that there is a change in the resistance value read, it automatically operates the warning indicator (8). Thus, the warning indicator (8) is automatically activated by determining whether there is any change of tissue inside the bone where the pedicle screw (1) is inserted, in other words whether the screw (1) proceeds inside the bone or on another tissue, during surgical operation according to the resistance value. In a preferred embodiment of the invention, there are resistance values of different tissues such as bone, muscle, vessel, nerve membrane inside the control box (6). The control box (6) is adapted such that it will keep resistance values in thereof. The control box (6) is adapted such that it will send signal to the warning indicator (8) automatically when any change occurs in the resistance values during surgical intervention. The control box (6) is adapted such that it will detect on which tissue an operation is performed at which resistance at that moment according to the value that it receives from the body (2) and the conductive end (4) continuously from the moment it is activated. Thus, the control box (6) continuously reads a resistance information during surgical operation and controls operation of the warning indicator (8).

In a preferred embodiment of the invention, the warning indicator (8) is adapted such that it will give audio, light or visual warning. In an alternative embodiment of the invention, there are different level lines or LEDs on the warning indicator (8). Bone thickness, tissue difference are measured according to the value read on the body (2) and the conductive end (4) in this embodiment. Thus, it is easily understood until which depth the pedicle screw (1) enters the bone and how strong it remains during surgical operation.

Claims

1. A pedicle screw (1 ) which is inserted into bones in spinal operations and gives warning by measuring in what type of tissue the surgeon proceeds during the operation, essentially characterized by:

- at least one outer body (2);

2. A pedicle screw (1) according to Claim 1; characterized by the body (2) which has at least one connection point (22) where the preferred electrical charge can be connected.

3. A pedicle screw (1) according to Claim 1; characterized by the body (2) which has electrical conductivity, is charged with positive (+) or negative (-) electrical charge. 4. A pedicle screw (1) according to Claim 1; characterized by the body (2) which is charged with the electrical charge that it receives over the connection point (22).

A pedicle screw (1) according to Claim 1; characterized by the body (2) which is coated with threads that will enable insertion into bone and the head (21) is located on its upper part.

6. A pedicle screw (1) according to Claim 1; characterized by the body (2) which has a hollow structure and inner surface of which is coated with insulation material.

7. A pedicle screw (1) according to Claim I; characterized by the insulation layer (3) which forms an insulated area between the body (2) and the conductive end (4), and has no electrical conductivity. 8. A pedicle screw (1) according to Claim 1; characterized by the conductive end (4) which comprises at least one connection point (41) where the preferred electrical charge can be connected on thereof.

9. A pedicle screw (1) according to Claim 1 ; characterized by the conductive end (4) which is charged with positive (+) or negative (-) electrical charge.

10. A pedicle screw (1) according to Claim 1; characterized by the battery (5) which provides electrical charge for the body (2) and the conductive end (4). 11. A pedicle screw (1) according to Claim 1; characterized by the battery (S) where the connection point (22) located on the body (2) and the connection point (41) located on the conductive end (4) are connected.

12. A pedicle screw (1) according to Claim 1; characterized by the control box (6) which is adapted such that it will send signal to the warning indicator (8) automatically when any change occurs in the resistance values during surgical intervention.

13. A pedicle screw (1) according to Claim 1; characterized by the warning indicator (8) which is adapted to give audio, light or visual warning according to the electrical resistance measured by the body (2) and the conductive end (4).

14. A pedicle screw (1) according to Claim 1; characterized by the body (2) and the conductive end (4) which read the resistance change in the surface where they contact.

15. A pedicle screw (1) according to Claim 1 ; characterized by the control box (6) which is adapted such that it will keep resistance values of different tissues such as bone, muscle, vessel or nerve membrane. 16. A pedicle screw (1) according to Claim 1; characterized by the control box (6) which is adapted to continuously read the resistance information that it receives from the body (2) and the conductive end (4) during surgical operation and to operate the warning indicator (8) according to the resistance value. 17. A pedicle screw (1) according to Claim 1; characterized by the head (21) which can be formed such that it can be angled independently of the body (2).