WO2020106243A2

WO2020106243A2 - An implant bar forming device and method

Info

Publication number: WO2020106243A2
Application number: PCT/TR2019/050525
Authority: WO
Inventors: Ozgur Kocaturk; Erkan YILDIRIM
Original assignee: Ozgur Kocaturk; Yildirim Erkan
Priority date: 2018-07-04
Filing date: 2019-07-03
Publication date: 2020-05-28
Also published as: TR201809509A2; WO2020106243A3

Abstract

The present invention is relates to a bar forming device (1) and a method for shaping the pectus bar (P) used for the correction of pectus excavatum and pectus carinatum deformities, essentially comprising a main body (2); a plurality of pistons (3), which are placed opposite to each other within the main body (2), and has a first end and a second end; a plurality of first motors (4), each of which is connected to the first end of one of the plurality of pistons (3), and which enables the piston (3) to which it is connected to be moved linearly; a plurality of first encoders (5), each of which is connected to one of the plurality of first motors (4) and measures the position of the shaft of the first motor (4) to which it is connected; a plurality of sensors (6), each of which is disposed at the second end of one of the pistons (3), and which generates a signal if the pistons (3) contact an object; a control unit (7) adapted to record and process the signals generated by the first encoders (5) and the sensors (6) and the position information and to generate signals to control the first motors (4) accordingly.

Description

AN IMPLANT BAR FORMING DEVICE AND METHOD

Field of the Invention

The present invention relates to a device for shaping the pectus bar used to correct the pectus excavatum and pectus carinatum deformities and a patient specific shaping method.

Background of the Invention

In the conventional rib cage deformity correction surgeries, one or two metal bars (e.g. lorenz bar) are selected according to the patient anatomy and the depth and extent of the deformity, and are placed under the sternum under general anesthesia via a video-assisted thoracoscopic (VATS) surgery. The Lorenz bar is formed to the targeted final shape during the surgical operation manually by using mechanical shaping, bending and straightening hand tools on the back-table. While this process itself takes 25-30 minutes in the competent hands, it may take more than an hour in inexperienced hands and may need to be repeated several times during the operation for complex anatomies. In summary, the prostheses (pectus bars) used in pectus excavatum (and pectus carinatum) operations are, as mentioned above, shaped by the operator during the operation by trial and error. In these surgeries, it may not be possible all the time to give the ideal shape depending on the anatomy of the patient during formation of a bar specific to the patient by using shaping, bending and straightening hand tools. Furthermore, since it is difficult to obtain the desired geometry at once during this manual process, which requires significant physical effort and experience, several attempts might be needed during implanting of the bar in a patient. In other words, if additional corrections are required after placing the pectus bar under the sternum at the required level, it is necessary to take the bar off from the body again. These additional steps increase the surgery time and the risk of complications (organ injury, etc.) during the removal and re-insertion of the bar.

The patent document numbered W02016088130A1, an application in the state of the art, discloses that a surgical plan is obtained upon taking three dimensional medical images of the region of interest of the patient and that after obtaining the coordinates from this surgical plan, these coordinates are used as inputs in the bar forming machine to bend a bar as desired by means of pistons. However, in this document, the deformity geometry of the patient is determined by expensive medical methods such as three-dimensional medical image acquisition and is then transferred to a digital medium.

Problems Solved by the Invention

The aim of the present invention is to provide a device for shaping the pectus bars used for the correction of pectus excavatum and pectus carinatum deformities.

In the present invention, a polymer-based strip guiding bar, which can be deformed permanently by plastic deformation, and by which the shape (mold) of the rib cage deformity of the patient can be obtained by placing it on the rib cage of the patient directly on the skin before or during the operation, is used for forming the required shape of the patient-specific bar. Then, this polymer based guide, which conforms with the patient deformity, is inserted into the two rows of pistons of the automatic pectus bar forming device and advanced from the initial position until each piston contacts with the guiding bar, and each piston length at the point where the force sensors contact to the guiding bar is recorded and transferred to the control unit by means of the encoders separately connected to each piston. In this way, the deformity geometry of the patient can be transferred to the digital medium in a cost effective and practical method without any need for expensive medical imaging methods, and then the shape that the pectus bar needs to acquire to correct this deformity is created by the operator via the software of the device and finalized by the surgeon, and afterwards the final guiding bar geometry is applied to the pectus bar, which is placed flat, by means of the bar forming device. Detailed Description of the Invention

A bar forming device developed to fulfill the objective of the present invention is illustrated in the accompanying figures wherein,

Figure 1. is a perspective view of the bar forming device according to the first preferred embodiment of the present invention.

Figure 2. shows (a) a perspective view, (b) a front view of the main body and pistons of the first preferred embodiment of the present invention. Figure 3. shows a front view of the main body, wherein a pectus bar bent by pistons is placed, in the first preferred embodiment of the present invention.

Figure 4. A) is a schematic view of the bar forming device comprising pistons fixed to the main body.

B) is a schematic view of the bar forming device wherein the distance between the pistons can be adjusted.

Figure 5. is a front view of the bar forming device according to the second preferred embodiment of the present invention.

Figure 6. is a perspective view of the bar forming device according to the second preferred embodiment of the present invention.

Figure 7. is another perspective view of the bar forming device according to the second preferred embodiment of the present invention.

Figure 8. is a schematic view of the bar forming device according to the second preferred embodiment of the present invention.

Figure 9. is a perspective view of one embodiment of the device wherein the pistons can be moved on the linear axle.

Figure 10. is a view of the detail A illustrated in Figure 9. Figure 11. is a front view of the device illustrated in Figure 9.

Figure 12. is a view of the detail B illustrated in Figure 11.

Figure 13. is a view of the detail A illustrated in Figure 11.

Figure 14. is a perspective view of another embodiment of the device wherein the pistons can be moved on the linear axle.

Figure 15. is a view of the detail A illustrated in Figure 14.

Figure 16. is a front view of the device illustrated in Figure 14.

Figure 17. is a view of the detail B illustrated in Figure 16.

Figure 18. is a view of the detail A illustrated in Figure 16.

The components in the figures are given reference numbers as follows:

1. Bar forming device

2. Main body

3. Piston

4. First motor

5. First encoder

6. Sensor

7. Control unit

8. Rail

9. Locking member

10. Second motor

11. Second encoder

12. Jaw

13. Third motor

14. Third encoder

15. Linear axle

16. Connecting member

17. Rotary gear

P. Pectus bar

M. Piston shaft The bar forming device (1) of the present invention has three preferred embodiments which are respectively described below.

In a first preferred embodiment of the invention, a bar forming device (1) for forming a bar used to correct a rib cage deformity basically comprises;

a main body (2),

a plurality of pistons (3), which are placed opposite to each other within the main body (2), comprises a piston shaft (M), and has a first end and a second end,

a plurality of first motors (4), each of which is connected to the first end of one of the plurality of pistons (3), and which comprises a shaft that enables the piston (3) to which it is connected to be moved linearly,

a plurality of first encoders (5), each of which is connected to one of the plurality of first motors (4) and measures the position of the shaft of the first motor (4) to which it is connected,

a plurality of sensors (6), each of which is disposed at the second end of one of the plurality of pistons (3), and generates a signal if the pistons (3) contact to an object,

a control unit (7) adapted to record and process the position information of the first motors (4) according to the signals generated by the first encoders (5) and the sensors (6) when the first motors (4) are moved, and to generate signals to control the first motors (4) accordingly.

The first preferred embodiment of the invention is shown in Figures 1-4. In this embodiment, the hydraulic, pneumatic or electric pistons (3), which are able to move independently of each other, are arranged in the main body (2), which is preferably in a square or rectangular form, on a single plane and in two rows one over the other. In order to move the pistons (3), there is provided a first motor (4) (preferably servo-motor), which is connected to each piston shaft (M), and which controls the forward/backward movement thereof in a controlled manner; and a first encoder (5) connected to the said first motors (4) is provided. On the second ends of the oppositely disposed pistons (3) facing each other, sensors (6) (for example, force measuring sensors) are provided to indicate the contact with the polymer guiding bar formed over the rib cage of the patient or the surface of the pectus-bar that will be shaped. The data coming from these sensors (6) and the data received from the first encoder (5) are recorded and processed by a control unit (7), and the electric signals controlling the first motors (4) are generated and transmitted to the said first motors (4).

In the first preferred embodiment of the present invention, the control unit (7) may be an electronic device such as a desktop computer, laptop computer, tablet computer, etc. comprising a processor, a memory unit, data input interface (e.g. keyboard, mouse, touch screen, etc.), a data input connector and/or a wireless data communication module such as Bluetooth, Wi-Fi (wireless fidelity) enabling the data connection with the main body (2). Furthermore, the control unit (7) may also comprise a graphical user interface that will provide communication between itself and the user, and a display device such as a monitor, touch screen, etc. that enables to display this graphical user interface to the user.

In the first preferred embodiment of the invention, the first motors (4) and thus the pistons (3) connected to these first motors (4) can, as shown in Figures 5-7, be arranged on a rail (8), which is located on the main body (2) and formed as channels provided on two opposite sides of the main body (2). In this embodiment of the invention, after the position of the pistons (3) is adjusted by the user, it can be locked preferably by using locking members (9). The said locking members (9) have a head and a screw end, and the said screw end is passed through a channel extending on the main body (2) and then inserted into a hole on the first motor (4) that is connected to the piston (3), and, when turned, the head of the locking member (9) moves towards and contacts the main body (2) thereby enabling to lock the first motor (4). In the first preferred embodiment of the invention, the said pistons (9), as shown in Figures 9-18, can be moved by the second motors (10), to which they are connected, automatically and independently of each other on the linear axle (15). Some of these embodiments are described below.

In one embodiment of the present invention, the two worm-gear threaded linear axles (15) are each connected from one end thereof to the roof of the main body (2) by means of a connecting member (16) (e.g. a connecting bracket) and extend along the roof and the base of the main body (2) (Figure 9-13). Here, the linear axle (15) passes through a channel provided in each of the plurality of second motors (10) and the second motors (10) are adapted to move linearly (e.g. forward and backward by rotating a gear connected to the output of the second motors (10) clockwise or counterclockwise on a linear axle (15)) along the said linear axle (15). In this embodiment of the present invention, the first motors (4) connected to each piston (3), preferably arranged on the rail (8), are each connected to a second motor (10) (preferably a servo motor). The positions of the said pistons (3) can be measured by the control unit (7) by means of the second encoder (11) provided in the second motors (10) to which the pistons (3) are connected. The distances between the pistons (3) are determined in accordance with the data received from the second encoders (11) by means of the software run by the control unit (7); and the distances between the pistons (3) can be adjusted to the distances automatically determined by the control unit (7) in accordance with the signals sent to the second motors (10) to which each piston (3) is connected. In this embodiment, the distance between the pistons (3) may alternatively be manually adjusted by the user upon disabling the electronic control of second motors (10). The features mentioned in this embodiment are explained in detail in the following paragraphs as alternative embodiments.

In another embodiment of the present invention, two linear axles (15) having gear rack are each connected from one end thereof to the main body (2) by means of a connecting member (16) (e.g. a bolt) and extend along the roof and the base of the main body (2) (Figure 14-18). On the linear axle (15), there is a plurality of second motors (10) adapted to move linearly along the said linear axle (15). There is one rotary gear (17) connected to the output of each of the second motors (10), and when the said rotary gear (17) is rotated by the second motor (10), the second motor (10) moves on the linear axle (15). In this embodiment of the present invention, each piston (3), preferably arranged on the rail (8), is connected to a second motor (10) (preferably a servo motor). The positions of the said pistons (3) can be measured by means of the second encoders (11) provided in the second motors (10) to which these pistons (3) are connected. The distances between the pistons (3) are determined by means of the software run by the control unit (7); and the distances between the pistons (3) can be adjusted to the distances automatically determined by the control unit (7) in accordance with the signals sent to the second motors (10) to which each piston (3) is connected. In this embodiment, the distance between the pistons (3) may alternatively be manually adjusted by the user upon disabling controlling unit of the second motors (10). The features mentioned in this embodiment are explained in detail in the following paragraphs as alternative embodiments.

A method which enables to shape a bar specific to a patient by using the above mentioned bar forming device (1) essentially comprises the steps of

producing a physical mold of the patient’s rib cage deformity using a guiding bar and placing the formed guiding bar between the pistons (3),

- the control unit (7) sending signals to the first motors (4) to move the pistons (3),

- the sensors (6) generating signals at the point where the pistons (3) contact the mold and sending them to the control unit (7),

- the control unit (7) stopping the first motors (4) that move the piston (3) on which the sensors (6) sending signals are provided,

- the first encoders (5) transferring the position data of the piston shaft (M), which is connected to the first motors (4) that are stopped, to the control unit (7), - the control unit (7) recording the related position data in a memory unit, placing a new pectus bar (P), which will be bent, between the pistons (3),

- the control unit (7) sending signals to the first motors (4) in accordance with the recorded position data,

shaping the pectus bar (P) by moving the pistons (3) by the first motors (4) in accordance with the incoming signals.

In the first preferred embodiment of the invention, first of all, the shape (mold) of the patient's rib cage deformity is obtained. To this end, in one embodiment of the invention a polymer-based guide strip bar, which can be deformed permanently by plastic deformation, is placed on the rib cage of the patient directly on the skin before or during the operation, and thus the shape (mold) of the rib cage deformity of the patient can be obtained. Then, this mold, which has the geometry of the patient's rib cage deformity, is placed between the two rows of pistons (3) of the bar forming device (1). The said pistons (3) are then moved from the starting position in accordance with the signals sent by the control unit (7) first to a driver controlling the first motors (4) and then to the first motors (4). It is described in various embodiments below which pistons (3) are to be moved by the control unit (7) during the molding and bending processes.

In one embodiment of the invention, after the step of“placing the mold between the pistons (3)” the length of the pectus bar (P) to be placed in the rib cage of the patient is selected via the graphical user interface and the number of pistons (3) and/or which pistons (3) are to be used during the process are determined. In this embodiment of the invention, the process of determining the pistons (3) and/or number thereof to be used is automatically carried out by the control unit (7) according to the entered pectus bar (P) length information. The said pistons (3), the number of which is automatically determined by the control unit (7), are then advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4). In another embodiment of the invention, after the step of “placing the mold between the pistons (3)” the number of pistons (3) and/or which pistons (3) are to be used during the process are entered manually by the user via the graphical user interface. Then, the pistons (3) manually determined by the user are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In another embodiment of the invention, after the step of “placing the mold between the pistons (3)”, all of the pistons (3) are included in the process by the control unit (7) so that all of them will be used during the process, and all of the pistons (3) are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In all of the above-mentioned embodiments in which the pistons (3) are moved by the control unit (7) during the molding process, the pistons (3) are fixedly connected to the main body (2) (Figures 1-4). In some embodiments described below, the pistons (3) are not fixed to the main body (2) and can be moved manually or automatically.

In one embodiment of the invention, after the step of“placing the mold between the pistons (3)”, the distances between the pistons (3) are adjusted by the user by manually moving the said pistons (3) on the rail (8), (Figures 5-18), and then the said pistons (3) are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In a further embodiment of the invention, after the step of“placing the mold between the pistons (3)”, the length of the pectus bar (P) to be placed in the rib cage of the patient is selected via the graphical user interface and the number of pistons (3) and/or which pistons (3) are to be used during the process are determined by the control unit (7). The distances between the said pistons (3) are adjusted by the user by manually moving the said pistons (3) on the rail (8), (Figures 5-18), and then the said pistons (3) are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In another embodiment of the invention, after the step of “placing the mold between the pistons (3)”, the length of the pectus bar (P) to be placed in the rib cage of the patient is selected via the graphical user interface, and accordingly the control unit (7) automatically adjusts the distances between all of the pistons (3) by moving the second motors (10), to which the pistons (3) are connected, on the linear axle (15) (Figures 9-18), and then the said pistons (3) are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In another embodiment of the invention, after the step of “placing the mold between the pistons (3)”, the length of the pectus bar (P) to be placed in the rib cage of the patient is selected via the graphical user interface and the number of pistons (3) and/or which pistons (3) are to be used during the process are determined by the control unit (7). Then, the distances between these determined pistons (3) are adjusted by moving the second motors (10), to which the said pistons (3) are connected, on the linear axle (15) by the control unit (7) (Figures 9- 18) and then the said pistons (3) are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In another embodiment of the invention, after the step of “placing the mold between the pistons (3)”, the number of pistons (3) and/or which pistons (3) are to be used during the process are entered by the operator via the graphical user interface; the distances between the said determined pistons (3) are adjusted by moving the second motors (10), to which the said pistons (3) are connected, on the linear axle (15) by the control unit (7) (Figures 9-18) and then the said pistons (3) are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4). As in any one of the above-mentioned embodiments, after the step of“advancing the pistons (3)”, at the point where the sensors (6) contact the mold, the said sensors (6) generate a signal, and in order to stop the piston (3) on which the sensors (6) generating this signal are located, the first motors (4) which move these pistons (3) are stopped by the control unit (7) by means of the motor drivers. Thus, since the pistons (3) are stopped when they come into contact with the mold placed between these pistons (3), deformation of the said mold is prevented.

In the next step, the lengths of the piston shaft (M) at the point where the sensors (6) contact the mold, in other words where they generate the signal, are transferred by the first encoders (5), which are connected to the first motors (4) that are connected to each piston (3) separately, to the control unit (7), and the corresponding coordinates are recorded by the control unit (7). In the following step, preferably using this recorded data, the digital version of the actual bar shape is generated by the control unit (7) and is preferably displayed on the screen. In this way, it is practically enabled to transfer the deformity geometry of the patient to the digital medium in a much cheaper and more practical manner without the need for expensive medical imaging methods. In these steps, since the distances between the pistons (3) do not change (are not required to be changed) when the mold is removed from between the pistons (3), the coordinate information of the second motors (10) is not required to be transmitted to the control unit (7) by the second encoders (11); however, optionally, the coordinate information can also be transmitted to the control unit (7) by the second encoders (11) and recorded in the control unit (7).

The shape that the pectus bar (P), which will be placed in the rib cage of the patient, needs to acquire to correct this rib cage deformity, in other words, the final bar geometry, is again provided by the same bar forming device (1). For this purpose, a straight pectus bar (P) is placed between the pistons (3). Then, a signal is sent to the first motors (4) according to the position of the piston shaft (M) corresponding to the piston (3) length coordinates which are received from the first encoders (5) and recorded by the control unit (7). The said first motors (4) move the pistons (3) to compress the pectus bar (P) according to the signal they receive. The said pistons (3) compress this pectus bar (P) and put it in its final form according to the patient’s rib cage deformity.

The second preferred embodiment of the invention is shown in Figures 5-7. This second embodiment, in addition to the first embodiment, includes jaws (12), third motors (13) driving the jaws (12), and third encoders (14) connected to these third motors (13).

In the second embodiment of the invention, as in the first embodiment, hydraulic or pneumatic pistons (3), which are able to move independently of each other, are arranged within the main body (2) on a single plane and in two rows one over the other. In order to move the pistons (3), there is provided a first motor (4) (preferably servo-motor), which is connected to each piston shaft (M), and which controls the forward/backward movement thereof in a controlled manner; and a first encoder (5) connected to the said first motors (4) is provided. On the second ends of the oppositely disposed pistons (3) facing each other, sensors (6) (for example, force measuring sensors) are provided. The data coming from these sensors (6) and the data received from the first encoder (5) are recorded and processed by a control unit (7), and the electric signals controlling the first motors (4) are generated and transmitted to the said first motors (4).

Furthermore, in this second embodiment of the invention, next to the hydraulic or pneumatic pistons (3) positioned perpendicular to the pectus bar (P), there is provided at least one third motor (13) (preferably a servo motor), which is able to move independently of each other and comprises a third encoder (14) (rotational encoder) rotatable about the central axis, and at least one jaw (12) rotated by the said at least one third motor (13). In the preferred embodiment of the present invention, there are provided two jaws (12), two third motors (13) and two third encoders (14). These jaws (12) are positioned next to the first and last piston (3) arranged side by side and preferably in the main body (2) at approximately equal distance from the upper and lower surfaces of the main body (2) and each of these jaws (12) are rotated by a third motor (13), and these third motors (13) are each connected to a third encoder (14).

In one embodiment of the present invention, the control unit (7) may be any device such as a desktop computer, laptop computer, tablet computer, etc. comprising a processor, a memory unit, a data input interface (e.g. keyboard, mouse, etc.), and a data input connector (or a wireless data communication module such as Bluetooth, Wi-Fi _ 33, etc.) enabling the data connection with the main body (2). Furthermore, the said control unit (7) may also comprise a graphical user interface that will provide communication between itself and the user, and a display device such as a monitor, touch screen, etc. that enables to display this graphical user interface to the user.

In one embodiment of the invention, the first motors (4) and thus the pistons (3) connected to these first motors (4) are arranged on a rail (8), which is located on the main body (2) and formed as channels provided on two opposite sides of the main body (2) ( Figures 5-7). In this embodiment of the invention, after the position of the pistons (3) is adjusted by the user, it can be locked preferably by using locking members (9). The said locking members (9) have a head and a screw end, and the said screw end is passed through a channel extending on the main body (2) and then inserted into a hole on the first motor (4) that is connected to the piston (3), and, when turned, the head of the locking member (9) moves towards and contacts the main body (2) thereby enabling to lock the first motor (4).

In some embodiments of the invention, the said pistons (9) can be moved by the second motors (10), to which they are connected, automatically and independently of each other on the linear axle (15) ( Figures 9-18). Some of these embodiments are described below.

In one embodiment of the present invention, a worm-gear threaded linear axle (15) is connected from one end thereof to the roof of the main body (2) by means of a connecting member (16) (e.g. a connecting bracket) and extends along the roof of the main body (2) (Figure 9-13). Here, the linear axle (15) passes through a channel provided in each of the plurality of second motors (10) and the second motors (10) are adapted to move linearly along the said linear axle (15). In this embodiment of the present invention, each piston (3), preferably arranged on the rail (8), is connected to a second motor (10) (preferably a servo motor). The positions of the pistons (3) can be measured by means of the second encoders (11) provided in the second motors (10) to which these pistons (3) are connected. The distances between the pistons (3) are determined in accordance with the data received from the second encoders (11) by means of the software run by the control unit (7); and the distances between the pistons (3) can be adjusted to the distances automatically determined by the control unit (7) in accordance with the signals sent to the second motors (10) to which each piston (3) is connected. In this embodiment, the distance between the pistons (3) may alternatively be manually adjusted by the user upon disabling the second motors (10). The features mentioned in this embodiment are explained in detail in the following paragraphs as alternative embodiments.

In another embodiment of the present invention, a linear axle (15) having gear rack is connected from one end thereof to the main body (2) by means of a connecting member (16) (e.g. a connecting bracket) and extend along the roof of the main body (2) (Figure 14-18). On the linear axle (15), there is a plurality of second motors (10) adapted to move linearly along the said linear axle (15). There is one rotary gear (17) connected to the output of each of the second motors (10), and when the said rotary gear (17) is rotated by the second motor (10), the second motor (10) moves on the linear axle (15). In this embodiment of the present invention, each piston (3), preferably arranged on the rail (8), is connected to a second motor (10) (preferably a servo motor). The positions of the said pistons (3) can be measured by means of the second encoders (11) provided in the second motors (10) to which these pistons (3) are connected. The distances between the pistons (3) are determined by means of the software run by the control unit (7); and the distances between the pistons (3) can be adjusted to the distances automatically determined by the control unit (7) in accordance with the signals sent to the second motors (10) to which each piston (3) is connected. In this embodiment, the distance between the pistons (3) may alternatively be manually adjusted by the user upon disabling the second motors (10). The features mentioned in this embodiment are explained in detail in the following paragraphs as alternative embodiments.

Another method which enables to shape a bar specific to a patient by using the bar forming device (1) disclosed in the second embodiment of the invention essentially comprises the steps of

producing a mold of the patient’s rib cage deformity and placing both ends of the mold in the jaws (12) connected to the third motor (13) rotating about its own axis, and the middle portion of the mold between the pistons

(3),

- the first encoders (5), which are connected to the first motors (4), and the third encoders (14), which are connected to the third motors (13) that are connected to the jaws (12), transferring the position data of the piston shaft (M), which is connected to the first motors (4) that are stopped, and the position data of the jaws (12) to the control unit (7),

- the control unit (7) recording the related position data in a memory unit, placing each end of the new pectus bar (P), which will be bent, in the jaws (12) and placing the middle portion thereof between the pistons (3), sending the positions of the jaws (12) and piston (3) related to the desired bar shape determined according to the position data recorded by the control unit (7) to the first motors (4) and the third motors (13) as a signal, shaping the pectus bar (P) as planned by moving the pistons (3) and the jaws (12) by the first motors (4) and the third motors (13) in accordance with the incoming signals.

In the second preferred embodiment of the invention, first of all, the shape (mold) of the patient’s rib cage deformity is obtained. To this end, in one embodiment of the invention, a polymer-based guide strip bar, which can be deformed permanently by plastic deformation, is placed on the rib cage of the patient directly on the skin before or during the operation, and thus the shape (mold) of the rib cage deformity of the patient can be obtained. Then, this mold, which has the geometry of the patient’s rib cage deformity, is placed between the two rows of pistons (3) of the bar forming device (1). The two ends of the mold are placed in the jaws (12), which are provided with a third encoder (14) (rotational encoder) thereon, and which can be rotated by a third motor (13) about its own axis. The said pistons (3) are then moved from the starting position in accordance with the signals sent by the control unit (7) first to a driver controlling the first motors (4) and then to the first motors (4). It is described in various embodiments below which pistons (3) are to be moved by the control unit (7) during the molding and bending processes.

In one embodiment of the invention, after the step of“placing the mold between the pistons (3)”, the length of the pectus bar (P) to be placed in the rib cage of the patient is selected via the graphical user interface and the number of pistons (3) and/or which pistons (3) are to be used during the process are determined. In this embodiment of the invention, the process of determining the pistons (3) and/or number thereof to be used is automatically carried out by the control unit (7) according to the entered pectus bar (P) length information. The said pistons (3), the number of which is automatically determined by the control unit (7), are then advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In another embodiment of the invention, after the step of “placing the mold between the pistons (3)”, the number of pistons (3) and/or which pistons (3) are to be used during the process are entered manually by the user via the graphical user interface. Then, the pistons (3), the number of which is manually determined by the user, are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In another embodiment of the invention, after the step of “placing the mold between the pistons (3)”, all of the pistons (3) and the jaws (12) located at the ends are included in the process by the control unit (7) so that all of them will be used during the process, and all of the pistons (3) are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In some embodiments described below, the pistons (3) are not fixed to the main body (2) and can be moved manually or automatically. In one embodiment of the invention, after the step of“placing the mold between the pistons (3)”, the distances between the pistons (3) are adjusted by the user by manually moving the said pistons (3) on the rail (8), (Figures 5-18), and then the said pistons (3) are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In one embodiment of the invention, after the step of“placing the mold between the pistons (3)”, the length of the pectus bar (P) to be placed in the rib cage of the patient is selected via the graphical user interface, and accordingly the control unit (7) automatically adjusts the distances between all of the pistons (3) by moving the second motors (10), to which the pistons (3) are connected, on the linear axle (15) (Figures 9-18), and then the said pistons (3) are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In another embodiment of the invention, after the step of “placing the mold between the pistons (3)”, the length of the pectus bar (P) to be placed in the rib cage of the patient is selected via the graphical user interface, and after the pectus bar (P) is placed such that it will pass through the jaws (12) provided at both ends, the number of pistons (3) and/or which pistons (3) are to be used during the process are determined by the control unit (7). Then, the distance between these determined pistons (3) are adjusted by moving the second motors (10), to which the pistons (3) are connected, on the linear axle (15) by the control unit (7) (Figures 9-18), and then the said pistons (3) and the jaws (12) at the ends are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

In another embodiment of the invention, after the step of “placing the mold between the pistons (3)”, the number of pistons (3) and/or which pistons (3) are to be used during the process are entered by the operator via the graphical user interface; the distances between the said determined pistons (3) are adjusted by moving the second motors (10), to which the said pistons (3) are connected, on the linear axle (15) by the control unit (7) (Figures 9-18) and then the said pistons (3) are advanced from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4).

As in any one of the above-mentioned embodiments, after the step of“advancing the pistons (3)”, at the point where the sensors (6) contact the mold, the said sensors (6) generate a signal, and in order to stop the piston (3) on which the sensors (6) generating this signal are located, the first motors (4) which move these pistons (3) are stopped by the control unit (7) by means of the motor drivers. Thus, since the pistons (3) are stopped when they come into contact with the mold placed between these pistons (3), deformation of the said mold is prevented.

In the next step, the lengths of the piston shaft (M) and the information of the angles of the jaws (12) in the designs including the jaws (12) at the point where the sensors (6) contact the mold, in other words where they generate the signal, are transferred by the first encoders (5), which are connected to the first motors (4) that are connected to each piston (3) and the jaws (12) separately, to the control unit (7), and the corresponding coordinates are recorded by the control unit (7). In the following step, preferably using this recorded data, the digital version of the actual bar shape is generated by the control unit (7) and is preferably displayed on the screen. In this way, it is practically enabled to transfer the deformity geometry of the patient to the digital medium in a much cheaper and more practical manner without the need for expensive medical imaging methods. In these steps, since the distances between the pistons (3) do not change (are not required to be changed) when the mold is removed from between the pistons (3), the coordinate information of the second motors (10) is not required to be transmitted to the control unit (7) by the second encoders (11); however, optionally, the coordinate information can also be transmitted to the control unit (7) and recorded in the control unit (7). The shape that the pectus bar (P), which will be placed in the rib cage of the patient, needs to acquire to correct this rib cage deformity, in other words, the final bar geometry, is again provided by the same bar forming device (1). For this purpose, a straight pectus bar (P) is placed between the pistons (3). Then, a signal is sent to the first motors (4) according to the position of the piston shaft (M) corresponding to the piston (3) length coordinates which are received from the first encoders (5) and recorded by the control unit (7). The said first motors (4) move the pistons (3) to compress the pectus bar (P) according to the signal they receive. The said pistons (3) compress this pectus bar (P) and put it in its final form according to the patient’s rib cage deformity.

In the third preferred embodiment of the invention (not shown in the figures), the bar forming device (1) essentially comprises

a main body (2);

- two pistons (3), which are placed opposite to each other within the main body (2), and has a first end and a second end;

- two first motors (4), each of which is connected to the first end of one of the pistons (3), and which comprises a shaft that enables the piston (3) to which it is connected to be moved linearly,

- two first encoders (5), each of which is connected to one of the first motors (4), and which measure the position of the shaft of the first motor (4) to which they are connected,

a plurality of sensors (6), each of which is disposed at the second end of one of the pistons (3), and which generates a signal if the pistons (3) contact an object

- two rails (8) provided in the main body (2) to enable the pistons (3) connected to the first motors (4) to move therein;

- two linear axles (15) which are fixed on the main body (2) and have a gear system thereon;

a second motor (10) which is connected to each first motor (4) and adapted to move along the linear axle (15); a second encoder (11) connected to each second motor (10) for measuring the positions of the pistons (3);

- two jaws (12) positioned between oppositely located pistons (3) for holding a mold or pectus bar (P);

a control unit (7) adapted to record, when the first motors (4) and the second motors (10) are moved, the position information of the first motors (4) and second motors (10) during the movement realized according to the signals generated by the first encoders (5), second encoders (11) and the sensors (6) and to generate the signals that will move the first motors (4) and the second motors (10) again according to this recorded position information.

In this third preferred embodiment of the invention, the two hydraulic, pneumatic or electric pistons (3), which are able to move independently of each other, are arranged in the main body (2), which is preferably in a square or rectangular form, on a single plane and in two rows one above the other. In order to move the pistons (3), there is provided a first motor (4) (preferably servo-motor), which is connected to each piston shaft (M), and which controls the forward/backward movement thereof in a controlled manner; and a first encoder (5) connected to the said first motors (4) is provided. On the second ends of the oppositely disposed pistons (3) facing each other, sensors (6) (for example, force measuring sensors) are provided to indicate the contact with the mold removed from the rib cage of the patient or the surface of the bar that will be shaped. The data coming from these sensors (6) and the data received from the first encoder (5) are recorded and processed by a control unit (7), and the electric signals controlling the first motors (4) are generated and transmitted to the said first motors (4).

The said control unit (7) may be an electronic device such as a desktop computer, laptop computer, tablet computer, etc. comprising a processor, a memory unit, data input interface (e.g. keyboard, mouse, touch screen, etc.), a data input connector and/or a wireless data communication module such as Bluetooth, Wi- Fi _ 33 (wireless fidelity) enabling the data connection with the main body (2).

Furthermore, the said control unit (7) may also comprise a graphical user interface that will provide communication between itself and the user, and a display device such as a monitor, touch screen, etc. that enables to display this graphical user interface to the user.

In this embodiment, the first motors (4) and thus the pistons (3) connected to these first motors (4) can be arranged on a rail (8), which is located on the main body

(2) and formed as channels provided on two opposite sides of the main body (2). The said pistons (9) can be moved by the second motors (10), to which they are connected, automatically and independently of each other on the linear axles (15). Some of these embodiments are described below.

In one embodiment of the present invention, the worm-gear threaded linear axles (15) are each connected from one end thereof to the roof and base of the main body (2) by means of a connecting member (16) (e.g. a connecting bracket) and extend along the roof and the base of the main body (2). Here, the linear axles (15) pass through a channel provided in each of the second motors (10), and the second motors (10) are adapted to move linearly (e.g. forward and backward by rotating a gear connected to the output of the second motors (10) clockwise or counterclockwise on a linear axle (15)) along the said linear axles (15). In this embodiment of the present invention, the first motors (4) connected to each piston

(3), preferably arranged on the rail (8), are each connected to a second motor (10) (preferably a servo motor). The positions of the said pistons (3) can be measured by the control unit (7) by means of the second encoder (11) provided in the second motors (10) to which the pistons (3) are connected. Here, the pistons (3) are moved by means of a software run by the control unit (7) in accordance with the data received from the sensors (6). The signals coming from the first encoders (5) and the second encoders (11) during the movement are recorded by the control unit (7) for later use. In another embodiment of the present invention, two linear axles (15) having gear rack are each connected from one end thereof to the main body (2) by means of a connecting member (16) (e.g. a bolt) and extend along the roof and the base of the main body (2). On the linear axles (15), there is a plurality of second motors (10) adapted to move linearly along the said linear axle (15). There is one rotary gear (17) connected to the output of each of the second motors (10), and when the said rotary gear (17) is rotated by the second motor (10), the second motor (10) moves on the linear axle (15). In this embodiment of the present invention, each piston (3), preferably arranged on the rail (8), is connected to a second motor (10) (preferably a servo motor). The positions of the said pistons (3) can be measured by means of the second encoders (11) provided in the second motors (10) to which these pistons (3) are connected. Here, the pistons (3) are moved by means of a software run by the control unit (7) in accordance with the data received from the sensors (6). The signals coming from the first encoders (5) and the second encoders (11) during the movement are recorded by the control unit (7) for later use.

A method which enables to shape a bar specific to a patient by using the said bar forming device (1) essentially comprises the steps of

producing a mold of the patient’s rib cage deformity and placing one end of the mold to each of the jaws (12),

- the control unit (7) sending signals to the first motors (4) and the second motors (10) to move the pistons (3),

- the control unit (7) comparing the said signals with a threshold value,

^■ if the said signal is higher than the threshold value, the control unit (7) generating the signals that will remove the pistons (3) from the mold; otherwise, the control unit (7) generating the signals that will move the pistons (3) closer to the mold, - the first encoders (5) and the second encoders (11) connected to the first motors (4) and the second motors (10) that are moved generating position signals during the movement,

- the control unit (7) recording the generated position signals in a memory unit,

placing a new pectus bar (P), which will be bent, in the jaws (12) located between the pistons (3),

- the control unit (7) sending signals to the first motors (4) and the second motors (10) in accordance with the recorded position data,

shaping the pectus bar (P) by moving the pistons (3) by the first motors (4) and the second motors (10) in accordance with the incoming signals.

In the first preferred embodiment of the invention, first of all, the shape (mold) of the patient’s rib cage deformity is obtained. To this end, in one embodiment of the invention, a polymer-based guide strip bar, which can be deformed permanently by plastic deformation, is placed on the rib cage of the patient directly on the skin before or during the operation, and thus the shape (mold) of the rib cage deformity of the patient can be obtained. Then, this mold, which has the geometry of the patient’s rib cage deformity, is placed in the jaws (12) located between the two rows of pistons (3) of the bar forming device (1). The said jaws (12) are fixed to the main body (2) as in the other preferred embodiments of the invention. The said pistons (3) are then moved from the starting position in accordance with the signals sent by the control unit (7) first to the drivers controlling the first motors (4) and the second motors (10), and then to the first motors (4) and the second motors (10).

After the step of advancing the pistons (3), the sensors (6) generate signals at the point where they contact the mold. This signal is compared with a threshold value by the control unit (7), and if the signal generated is higher than this threshold value, a signal is generated to move the piston (3), on which the sensor (6) generating this signal is located, away from the mold. If the said signal is lower than the threshold value, a signal is generated by the control unit (7) to move the piston (3), on which the sensor (6) generating this signal is located, closer to the mold. Thus, during the movement of the pistons (3), their contact with the mold placed between these pistons (3) is adjusted to prevent deformation of the said mold.

The position and length information generated by the first encoders (5) and the second encoders (11) during the movement of the said pistons (3) are recorded by the control unit (7). By using this recorded data, the digital version of the actual bar shape is generated by the control unit (7) and is preferably displayed on the screen. In this way, it is practically enabled to transfer the deformity geometry of the patient to the digital medium in a much cheaper and more practical manner without the need for expensive medical imaging methods.

The shape that the pectus bar (P), which will be placed in the rib cage of the patient, needs to acquire to correct this rib cage deformity, in other words, the final bar geometry, is again provided by the same bar forming device (1). For this purpose, a straight pectus bar (P) is placed in the jaws (12) located between the pistons (3). Then, a signal is sent to the first motors (4) and the second motors (10) according to the data related to the lengths and positions of the piston (3) which are received from the first encoders (5) and the second encoders (11) and recorded by the control unit (7). The said first motors (4) and the second motors (10) move the pistons (3) to compress the pectus bar (P) according to the signal they receive. The said pistons (3) compress this pectus bar (P) and put it in its final form according to the patient’s rib cage deformity.

In the above described embodiments, the bar forming device (1) is used for shaping a bar, however the invention is not limited thereto, as it can also be used for shaping other parts such as rods, beams, plates, etc.

Claims

1. A bar forming device (1) comprising a main body (2); a plurality of pistons (3), which are placed opposite to each other within the main body (2), and have a first end and a second end; a plurality of first motors (4), each of which is connected to the first end of one of the plurality of pistons (3), and which comprises a shaft that enables the piston (3) to which it is connected to be moved linearly, a plurality of first encoders (5), each of which is connected to one of the plurality of first motors (4) and measures the position of the shaft of the first motor (4) to which it is connected, and characterized by

a plurality of sensors (6), each of which is disposed at the second end of one of the plurality of pistons (3), and generates a signal if the pistons (3) contact an object,

2. Bar forming device (1) according to Claim 1, characterized by a hydraulic piston (3).

3. Bar forming device (1) according to Claim 1, characterized by a pneumatic piston (3).

4. Bar forming device (1) according to Claim 1, characterized by an electric piston (3).

5. Bar forming device (1) according to Claim 1, characterized by a sensor (6) which is a force measuring sensor.

6. Bar forming device (1) according to Claim 1, characterized by two rails (8) provided in the main body (2) to enable the pistons (3) connected to the first motors (4) to move.

7. Bar forming device (1) according to Claim 6, characterized by locking members (9) for fixing the position of the pistons (3).

8. Bar forming device (1) according to Claim 7, characterized by a channel which extends on the main body (2) for passing the screw end of the locking members (9) having a head and a screw end therethrough, and a hole which is located on the first motors (4) that are connected to the piston (3) for passing the said screw end therehrough.

9. Bar forming device (1) according to Claim 6, characterized by two linear axles (15) which are fixed on the main body (2) opposite to each other and have a worm gear thereon.

10. Bar forming device (1) according to Claim 6, characterized by two linear axles (15) which are fixed on the main body (2) opposite to each other and have a gear rack thereon.

11. Bar forming device (1) according to Claim 9 or 10, characterized by one second motor (10) which is connected to each first motor (4) and adapted to move on the linear axle (15).

12. Bar forming device (1) according to Claim 11, characterized by one second encoder (11) provided in each second motor (10) for measuring the positions of the pistons (3).

13. Bar forming device (1) according to Claim 12, characterized by the control unit (7) which is adapted to send signals to the second motors (10) to which each piston (3) is connected and adjust the distances between the pistons (3).

14. Bar forming device (1) according to any one of Claims 1 to 13, characterized by at least one jaw (12) positioned between oppositely located pistons (3) for holding a mold or pectus bar (P); at least one third motor (13) connected to the said at least one jaw (12) for rotating the said at least one jaw (12) about a central axis; and at least one third encoder (14) connected to the said at least one third motor (13).

15. Bar forming device (1) according to Claim 14, comprising two jaws (12), two third motors (13) and two third encoders (14).

16. A method for shaping a bar specific to a patient by using the bar forming device (1) according to any of Claims 1 to 15, characterized by the steps of producing a mold of the patient's rib cage deformity and placing the mold between the pistons (3),

- the first encoders (5) transferring the position data of the piston shaft (M), which is connected to the first motors (4) that are stopped, to the control unit (7),

- the control unit (7) recording the related position data in a memory unit, placing a new pectus bar (P), which will be bent, between the pistons (3),

17. Method according to Claim 16, characterized in that, in the step of “producing a mold of the patient's rib cage deformity and placing the mold between the pistons (3)”, a mold that is a polymer-based guide strip bar, which can be deformed permanently by plastic deformation, is placed between the pistons (3).

18. Method according to Claim 16, characterized by the following steps after the step of“producing a mold of the patient's rib cage deformity and placing the mold between the pistons (3)”;

selecting the length of the pectus bar (P) to be placed in the rib cage of the patient via a graphical user interface located in the control unit (7),

- the control unit (7) automatically determining the number of pistons (3) and/or which pistons (3) are to be used during the process according to the entered pectus bar (P) length information.

19. Method according to Claim 16, characterized by the step of “the user manually entering the number of pistons (3) and/or which pistons (3) are to be used during the process via the graphical user interface” following the step of “producing a mold of the patient's rib cage deformity and placing the mold between the pistons (3)”.

20. Method according to Claim 16, characterized by the step of“advancing all of the pistons (3) from the starting position in accordance with the signals sent by the control unit (7) to the first motors (4)”, in the step of“the control unit (7) sending signals to the first motors (4) to move the pistons (3)”.

21. Method according to Claim 16, characterized by the step of“adjusting the distances between the pistons (3) by moving the said pistons (3), which will be used during the process, on the rail (8) by the user”, following the step of “producing a mold of the patient's rib cage deformity and placing the mold between the pistons (3)”.

22. Method according to Claim 16, characterized by the step of“selecting the length of the pectus bar (P) to be placed in the rib cage of the patient via the graphical user interface, and accordingly the control unit (7) automatically adjusting the distances between all of the pistons (3) by moving the second motors (10), to which the pistons (3) are connected, on the linear axle (15)”, following the step of“producing a mold of the patient's rib cage deformity and placing the mold between the pistons (3)”.

23. Method according to Claim 16, characterized by the step of“adjusting the distances between the pistons (3) to be used during the process by moving the second motors (10), to which the said pistons (3) are connected, on the linear axle (15) by the control unit (7)”, following the step of“producing a mold of the patient's rib cage deformity and placing the mold between the pistons (3)”.

24. Method according to Claim 15 or 16 characterized in that the step of“the control unit (7) recording the related position data in a memory unit” is followed by the step of“producing the digital version of the actual bar shape by the control unit (7) by using the said data”.

25. Method according to any one of Claims 16 to 24, comprising the following steps after the step of“producing a mold of the patient's rib cage deformity and placing the mold between the pistons (3)”:

placing both ends of the mold in the jaws (12) connected to the third motor (13) rotating about its own axis, and the middle portion of the mold between the pistons (3);

in the step of“the first encoders (5) transferring the position data of the piston shaft (M), which is connected to the first motors (4) that are stopped, to the control unit (7)”; the first encoders (5), which are connected to the first motors (4), and the third encoders (14), which are connected to the third motors (13) that are connected to the jaws (12), transferring the position data of the piston shaft (M), which is connected to the first motors (4) that are stopped, and the position data of the jaws (12) to the control unit (7),

in the step of“placing a new pectus bar (P), which will be bent, between the pistons (3)”; placing each end of the pectus bar (P), which will be bent, in the jaws (12) and placing the middle portion thereof between the pistons

(3),

in the step of“the control unit (7) sending signals to the first motors (4) in accordance with the recorded position data”, sending the positions of the jaws (12) and piston (3) related to the desired bar shape determined according to the position data recorded by the control unit (7) to the first motors (4) and the third motors (13) as a signal,

in the step of“shaping the pectus bar (P) by moving the pistons (3) by the first motors (4) in accordance with the incoming signals”, shaping the pectus bar (P) as planned by moving the pistons (3) and the jaws (12) by the first motors (4) and the third motors (13) in accordance with the incoming signals.

26. A bar forming device (1) comprising a main body (2); two pistons (3), which are placed opposite to each other within the main body (2), and has a first end and a second end; two first motors (4), each of which is connected to the first end of one of the pistons (3), and which comprises a shaft that enables the piston (3) to which it is connected to be moved linearly; two first encoders (5), each of which is connected to one of the first motors (4), and which measure the position of the shaft of the first motor (4) to which they are connected; and characterized by

a plurality of sensors (6), each of which is disposed at the second end of one of the pistons (3), and which generates a signal if the pistons (3) contact an object,

- two rails (8) provided in the main body (2) to enable the pistons (3) connected to the first motors (4) to move therein, - two linear axles (15) which are fixed opposite to each other on the main body (2) and have a gear system thereon,

a second motor (10) which is connected to each first motor (4) and adapted to move along the linear axle (15),

a second encoder (11) connected to each second motor (10) for measuring the positions of the pistons (3),

- two jaws (12) positioned between oppositely located pistons (3) for holding a mold or pectus bar (P),

27. A method for shaping a bar specific to a patient by using the bar forming device (1) according to Claim 26, characterized by the steps of

- the control unit (7) comparing the said signals with a threshold value,

- shaping the pectus bar (P) by moving the pistons (3) by the first motors (4) and the second motors (10) in accordance with the incoming signals.