RU2843064C1 - Device for insertion of bone rods when installing external fixation apparatus - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: bone nail insertion device for inserting an external fixation apparatus comprises a tube, coplanar holders of the first – third sensors in which there are first – third ultrasonic sensors, and first – fourth bars. First and second holders are arranged so that planes of ultrasonic beams of ultrasonic sensors are perpendicular to each other, and ultrasonic beam of first ultrasonic sensor passes through middle of ultrasonic beam of second ultrasonic sensor. First sensor holder has first and second parallel through holes arranged on both sides of first ultrasonic sensor and including tubes for protection of soft tissues. Axes of the first and second holes are located in the plane of the ultrasonic beam of the first ultrasonic sensor. To the holder of the second sensor there fixed is the first plank located in the plane of the holder of the second sensor, and in the plane parallel to the plane of ultrasonic beam of the second ultrasonic sensor. To first bar perpendicular and fixed is second bar made in form of parallelepiped and located in plane parallel to plane of ultrasonic beam of second ultrasonic sensor. Third plate is movable, is arranged with the possibility of displacement along the second bar, has the first and the second through holes. Axis of second hole is located in plane parallel to plane of ultrasonic beam of second ultrasonic sensor and perpendicular to axis of first through hole of third movable plank. Fourth bar is made in the form of a parallelepiped, is located on the third holder in the second through hole of the third movable bar with possibility of movement and so that the axis of the second through hole of the holder of the first sensor is located in the plane of the ultrasonic beam of the third ultrasonic sensor when it is moved.

EFFECT: higher accuracy of bone nail insertion, reduced radiation load on the patient and medical personnel.

1 cl, 8 dwg

Description

The invention relates to medicine, namely to surgical traumatology and orthopedics, and can be used in performing operations to install rod external fixation devices (RVED) to control the insertion of bone rods and reposition of bone fragments.

The application of rod AVFs is usually performed under X-ray control (electron-optical converter), which is accompanied by a significant radiation load on the patient and medical personnel. In some cases, AVFs can be installed without X-ray control, which is accompanied by various technical errors during installation, which lead to serious complications.

The following devices for inserting bone rods are currently known.

A device for inserting bone rods is known, Russian Federation patent for invention No. 2606269. The device is a T-shaped handle into which a rod is inserted. The rod is screwed into the bone by the surgeon turning the handle. The rod is inserted based on the surgeon's tactile sensations.

The disadvantage of the device is that when using it, errors in inserting the rod are possible (deviation from the bone center, excessive rod exit beyond the boundaries of the second cortical bone layer). It is not possible to perform repositioning of bone fragments without using an electron-optical converter, and its use increases the radiation load on the patient and medical personnel.

A device for inserting bone rods is known, Russian Federation patent for invention No. 2746973. The device consists of parts of the Ilizarov apparatus kit, namely: a threaded coupling, a threaded rod, a bolt, and nuts. The transverse opening of the coupling is intended for Shantz or Steinman rods. Both ends of the threaded coupling are intended for inserting the threaded rod and the threaded shank of the bolt. It is possible to rotate the threaded rod and/or the threaded shank clockwise to press and lock Shantz or Steinman rods in a given position with the end surface of the threaded rod and, additionally, the threaded shank of the bolt.

The disadvantage of the device is that when using it, errors in inserting the rod are possible (deviation from the bone center, excessive rod exit beyond the boundaries of the second cortical bone layer). The use of this device does not allow for precise repositioning of bone fragments without using an electron-optical converter.

The closest known device to the claimed one is a device for inserting bone rods, Russian Federation patent for invention No. 2116764. The device contains a hollow cylinder, in the bottoms of which a threaded axis with a handle and a working part is installed on threads. The cylinder is equipped with a handle and is made with a longitudinal groove in its wall and scales applied to the surface of the cylinder. On the threaded axis there are ring-shaped projections, between which a ring with a pin is installed with the possibility of rotation, protruding through the groove of the cylinder above its surface. An indicator arrow is fixed on the pin with the possibility of moving its ends along the scales.

The disadvantage of this device is the impossibility of accurately assessing the point of insertion of the rod into the bone. The device allows you to assess the degree of immersion of the rod into the bone, however, errors are possible, since the depth of immersion of the rod depends on the point of insertion of the rod into the bone. Also, the device does not allow repositioning bone fragments without X-ray control.

The objective of the invention is to increase the accuracy of bone rod installation, reduce radiation exposure to the patient and medical personnel, expand the functional capabilities of the prototype, and prevent complications.

In order to solve the stated problem, in the known device for introducing bone rods, consisting of a tube, holders of the first to third sensors located in the same plane, in which the first to third ultrasonic sensors are placed, and first to fourth bars are additionally introduced, wherein the first and second holders are located in such a way that the planes of the ultrasonic beams of the ultrasonic sensors are perpendicular to each other, and the ultrasonic beam of the first ultrasonic sensor passes through the middle of the ultrasonic beam of the second ultrasonic sensor, the holder of the first sensor has first and second parallel through holes located on both sides of the first ultrasonic sensor and including tubes for protecting soft tissues, and the axes of the first and second holes are located in the plane of the ultrasonic beam of the first ultrasonic sensor, the first bar, located in the plane of the holder of the second sensor, and in a plane parallel to the plane of the ultrasonic beam of the second ultrasonic sensor, is fixedly fixed to the holder of the second sensor, perpendicularly and fixedly to the first bar, a second bar, made in the form of a parallelepiped and located in a plane parallel to the plane ultrasonic beam of the second ultrasonic sensor, the third bar is made movable, is located with the possibility of movement along the second bar, has first and second through holes, the axis of the second hole is located in a plane parallel to the plane of the ultrasonic beam of the second ultrasonic sensor and perpendicular to the axis of the first through hole of the third movable bar, and the fourth bar is made in the form of a parallelepiped, is located on the third holder in the second through hole of the third movable bar with the possibility of movement and in such a way that the axis of the second through hole of the holder of the first sensor is located in the plane of the ultrasonic beam of the third ultrasonic sensor during its movement.

When studying other known design and technical solutions in this field of medicine, the specified set of features that distinguishes the invention from the prototype was not identified.

Fig. 1 shows a diagram of the device (the tubes in the through holes are not shown), Fig. 2 shows a diagram of the holders of the first and second sensors, Fig. 3 shows a diagram of the holder of the third sensor, a diagram of the third movable bar, Fig. 4 shows a diagram of the device located on a model of a fragment of a human limb segment (the tubes in the through holes are not shown), Fig. 5 shows a) a diagram of the arrangement of the device on the limb at the level of the second ultrasonic sensor (in the section) and b) a diagram of the ultrasound image corresponding to it; Fig. 6 shows a) a diagram of the arrangement of the device on the limb at the level of the first ultrasonic sensor (in the section) and b) a diagram of the ultrasound image corresponding to it; Fig. 7 shows a) a diagram of the arrangement of the device on the limb at the level of the third ultrasonic sensor (in the section) and b) a diagram of the ultrasound image corresponding to it; Fig. 8 shows a diagram of the installation of bone rods and reposition of bone fragments.

The following designations are used in Figure 1:

1 - third ultrasonic sensor;

2 - holder of the third sensor;

3 - holder of the first sensor;

4 - first through hole;

5 - first ultrasonic sensor;

6 - second through hole;

7 - the fourth bar;

8 - third movable bar;

9 - second bar;

10 - first bar;

11 - holder of the second sensor;

12 - second ultrasonic sensor;

The following designations are used in Figure 2:

3 - holder of the first sensor;

4 - first through hole;

6 - second through hole;

9 - second bar;

10 - first bar;

11 - holder of the second sensor;

The following designations are used in Figure 3:

2 - holder of the third sensor;

7 - the fourth bar;

8 - third movable bar;

13 - the first through hole of the third movable bar;

14 - the second through hole of the third movable bar;

The following designations are used in Figure 4:

1 - third ultrasonic sensor;

2 - holder of the third sensor;

3 - holder of the first sensor;

4 - first through hole;

5 - first ultrasonic sensor;

8 - third movable bar;

9 - second bar;

10 - first bar;

11 - holder of the second sensor;

12 - second ultrasonic sensor;

15 - fragment of a limb segment;

16 - tubular bone;

The following designations are used in Figure 5:

10 - first bar;

11 - holder of the second sensor;

12 - second ultrasonic sensor;

15 - fragment of a limb segment;

16 - tubular bone;

17 - boundaries of the ultrasonic beam;

18 - line of reflection of ultrasonic beam;

19 - acoustic shadow;

O - axis of the middle of the ultrasonic beam of the second ultrasonic sensor;

The following designations are used in figure 6:

3 - holder of the first sensor;

4 - first through hole;

5 - first ultrasonic sensor;

6 - second through hole;

11 - holder of the second sensor;

15 - fragment of a limb segment;

16 - tubular bone;

17 - boundaries of the ultrasonic beam;

18 - line of reflection of ultrasonic beam;

19 - acoustic shadow;

20 - rod;

21 - tube;

K - the axis of the middle of the ultrasonic beam of the first ultrasonic sensor;

M is the axis of the surface of the first ultrasonic sensor;

N - axis of the ultrasonic beam reflection line;

The following designations are used in figure 7:

1 - third ultrasonic sensor;

2 - holder of the third sensor;

6 - second through hole;

7 - the fourth bar;

8 - third movable bar;

9 - second bar;

10 - first bar;

11 - holder of the second sensor;

15 - fragment of a limb segment;

16 - tubular bone;

17 - boundaries of the ultrasonic beam;

18 - line of reflection of ultrasonic beam;

19 - acoustic shadow;

20 - rod;

21 - tube;

L - length of the protruding part of the bone rod;

The following designations are used in figure 8:

16 - tubular bone;

20 - rod;

22 - external fixation device rod;

23 - external fixation device retainer;

E - axis of the rod of the external fixation device;

F - bone axis.

The claimed device for inserting bone rods consists of a first sensor holder 3 located in the same plane with a first ultrasonic sensor 5 located therein, a second sensor holder 11 with a second ultrasonic sensor 12 located therein, located in such a way that the planes of the ultrasonic beams located in the holders 3 and 11 of the first 5 and second 12 ultrasonic sensors are perpendicular to each other and the ultrasonic beam of the first ultrasonic sensor 5 passes through the middle of the ultrasonic beam of the second ultrasonic sensor 12. In the first sensor holder 3, there are first 4 and second 6 through holes located parallel to each other on both sides of the first ultrasonic sensor 5 in such a way that the axes of the first 4 and second 6 through holes are located in the plane of the ultrasonic beam of the first ultrasonic sensor 5. Tubes 21 are located in the first 4 and second 6 through holes. The first bar 10 is fixedly fixed to the second sensor holder 11, also located in the plane of the holder of the second sensor 11 and in a plane parallel to the plane of the ultrasonic beam of the second ultrasonic sensor 12. A second bar 9, made in the form of a parallelepiped, is fixed perpendicular to the first bar 10 and is located in a plane parallel to the plane of the ultrasonic beam of the second ultrasonic sensor 12. The device also contains a third movable bar 8, having a first through hole 13 of the third movable bar 8, corresponding to the second bar 9, and located on it with the possibility of movement along the second bar 9, and a second through hole 14 of the third movable bar 8, the axis of which is located in a plane parallel to the plane of the ultrasonic beam of the second ultrasonic sensor 12 and perpendicular to the axis of the first through hole 13 of the third movable bar 8. The device also contains a holder of the third sensor 2 with a third ultrasonic sensor 1 located in it, containing a fourth bar 7, made in the form of a parallelepiped, corresponding to the second through opening 14 of the third movable bar 8, located in the second through opening 14 of the third movable bar 8 with the possibility of movement in the second through opening 14 of the third movable bar 8 in such a way that the axis of the second through opening 6 of the holder of the first sensor 3 is located in the plane of the ultrasonic beam of the third ultrasonic sensor 1 during its movement.

The components of the claimed device for inserting bone rods can be implemented as follows.

The clamps of the first, second, third sensors 3, 11, 2, tube 20, third movable bar 8 can be made of medical steel.

Typical Shantz or Steinmann rods used in traumatology and orthopedics can be used as rods 21.

The ultrasound sensors 1, 5, 12 can be sensors of stationary or portable ultrasound devices, such as RuScan 60 (Russia) or ELS-MED-MINI (Russia). During the operation, the ultrasound sensors are placed in sterile covers. It is possible to use three sensors simultaneously during operation of the device. It is also possible to sequentially install one sensor in each of the sensor holders 2, 3, 11.

Thus, the implementation of the claimed device for the introduction of bone rods does not raise any doubts, since standard medical instruments, devices and materials are used for its manufacture.

The operating principle of the claimed device is as follows.

During the operation, the device is applied to the limb 15 at the site of the proposed insertion of the rods 20. Based on the information from the first ultrasound sensor 5 and the second ultrasound sensor 12, the position of the device is adjusted for the most optimal insertion of the rods 20 and the exclusion of damage to the vessels and nerves. The device is positioned so that the first ultrasound sensor 5 is located along the long axis of the bone 16, and the second ultrasound sensor 12 is perpendicular to it. Next, using a sterile marker inserted into the first through hole 4 and the second through hole 6, mark the locations of the installation of the rods 20 of the AVF in one of the fragments of the tubular bone 16. An incision is made in the soft tissues at the locations where the rods 20 are inserted to the tubular bone 16, the soft tissues are moved apart, and a tube 21 is installed in the second through hole 6 to protect the soft tissues during the process of screwing in the rod 20. Next, based on the information received on the display of the ultrasound device, determine the point of insertion of the rod 20 into the second through hole 6. The display of the ultrasound device will visualize the line of reflection of the ultrasonic beam 18 from the bone, followed by the zone of acoustic shadow 19. The device and, accordingly, the second ultrasonic sensor 12 are positioned so that the most protruding part of the line of reflection of the ultrasonic beam 18 is on the axis O, corresponding to the middle of the ultrasonic beam of the second sensor (Fig. 5). In this position of the device, the rod 20, when inserted into the tubular bone 16, will pass through its center and be located parallel to the O axis. Next, to eliminate possible displacement of the rod 20, it is screwed into the cortical layer of the tubular bone 16 (closest to the device) to a depth of about 1-2 mm.

Next, based on the information received on the display of the ultrasound apparatus from the first ultrasound sensor 5, the device is positioned so that the middle of the ultrasound beam of the first ultrasound sensor 5 - the K axis is perpendicular to the surface of the tubular bone 16, i.e. the axis of the surface of the first ultrasound sensor M and the axis of the cortical layer, i.e. the axis of the reflection line of the ultrasound beam N of the tubular bone 16 are parallel to each other (Fig. 6). The axis of the rod 20 is parallel to the K axis of the middle of the ultrasound beam of the first ultrasound sensor 5. Thus, with such an arrangement of the device, the rod 20 is inserted perpendicular to the F axis of the tubular bone 16 (Fig. 8). In the process of screwing the rod 20 into the tubular bone 16, the depth of insertion of the rod 20 is estimated (Fig. 7). To do this, based on the information received on the display of the ultrasound device from the third ultrasound sensor 1, the length of the protruding part of the rod from the bone L is estimated. This is necessary to prevent excessive protrusion of the rod 20 from the tubular bone 16 and possible damage to the vessels and nerves.

During the use of the device, the first sensor retainer 3 and the second sensor retainer 11 are located on the patient's skin (with ultrasound sensors 5 and 12 located in them, respectively). To ensure contact of the third ultrasound sensor 1 with the skin and to obtain the required ultrasound image on the display of the ultrasound device, the third sensor retainer 2 is moved along the axis of the fourth bar 7 and the axis of the second bar 9. This ensures contact of the third ultrasound sensor 1 with the skin.

After the first rod 20 has been inserted into the tubular bone, the device is removed, leaving the tube 21 on the installed rod 20. Next, the device is installed on the inserted rod 20 and the tube 21 so that they are located in the first through hole 4, and the previously made skin incision for inserting the second rod 20 is located opposite the second through hole 6. Next, the tube 21 is installed in the made incision and in the through hole 6 to protect the soft tissues during the process of screwing in the next rod 20. The second and subsequent rods 20 are inserted into the tubular bone 16 in a similar manner to the insertion of the first rod 20.

Two rods 20 are inserted into one of the fragments of the tubular bone 16 and two into the second fragment. The rods are fixed in pairs to the rod 22 of the AVF using fixators 23 at the same distance from the ends of the rods 20. Then, the bone fragments 16 are repositioned and the rods 22 are fixed to each other in the required position (Fig. 8). Since the rods 20 are inserted to the same depth (the measurement of the distance L is controlled according to the data from the third ultrasound sensor), the axis of the bone F is parallel to the axis E of the rod 22, since the rods 20 are inserted perpendicular to the axis of the bone F in the frontal plane (Fig. 8, top view). Since the axes of the inserted bone fragments 16 of the rods 20 are parallel to each other and they pass through the center of the tubular bone, the bone axis F is parallel to the axis E of the rod 22 (or coincides with it) in the sagittal plane (Fig. 8, front view). Thus, in each fragment of bone 16, the bone axis F is parallel to the axis of the rod E in two perpendicular planes (frontal and sagittal). That is, for repositioning the fragments of tubular bone 16, it is necessary to align the axes E of the rods 22 connected to each fragment of tubular bone 16. Thus, by aligning the axes E of the rods 22 in the sagittal and frontal planes, the axes F of the proximal and distal fragments of tubular bone 16 are aligned, i.e. repositioning and precise matching of the fragments with each other are performed (Fig. 8).

If necessary, additional insertion of rods 20 into other sections of the tubular bone 16 is possible to create a multi-plane AVF to increase the stability of the structure.

An example of using the proposed device.

To test the proposed device, an experimental study was conducted on a human femur model. For this, the femur model (Sawbones) was placed in a gelatin solution. After the gelatin solidified, it was cooled to +4 degrees C, thereby modeling the human femur. A comminuted fracture of the middle third of the femur diaphysis was modeled.

The working sample of the device was made using 3D printing technologies from ABC plastic. Linear guides were used to move the third sensor 2 retainer. The Mindray DC-3 ultrasound device (China) was used.

The introduction of bone rods was performed using a working model of the device. The position of the rods and the reposition of bone fragments were controlled using a flexible endoscope inserted into the femoral canal. Five experiments were conducted. The 20 rods were introduced in the frontal and sagittal planes. In all cases, 2 rods were installed in the femoral fragments and the reposition of bone fragments was performed. In all cases, the rods were located in the center of the femur, protruding beyond the cortical layer by 3 mm in accordance with the preoperative planning. In all cases, the reposition of bone fragments with their satisfactory position was achieved.

The technical result of the claimed invention is: increased accuracy of installation of bone rods, reduced radiation exposure to the patient and medical personnel, expanded functionality of the prototype, and prevention of complications.

Claims (1)

A device for inserting bone rods when installing an external fixation device, comprising a tube, characterized in that it additionally includes holders of the first to third sensors located in the same plane, in which the first to third ultrasonic sensors are placed, and first to fourth bars, wherein the first and second holders are located in such a way that the planes of the ultrasonic beams of the ultrasonic sensors are perpendicular to each other, and the ultrasonic beam of the first ultrasonic sensor passes through the middle of the ultrasonic beam of the second ultrasonic sensor, the holder of the first sensor has first and second parallel through holes located on both sides of the first ultrasonic sensor and including tubes for protecting soft tissues, and the axes of the first and second holes are located in the plane of the ultrasonic beam of the first ultrasonic sensor, the first bar is fixedly fixed to the holder of the second sensor, located in the plane of the holder of the second sensor, and in a plane parallel to the plane of the ultrasonic beam of the second ultrasonic sensor, the second bar, made in the form of a parallelepiped and located in the plane, is fixed perpendicularly and fixed to the first bar, parallel to the plane of the ultrasonic beam of the second ultrasonic sensor, the third bar is made movable, is located with the possibility of movement along the second bar, has first and second through holes, the axis of the second hole is located in a plane parallel to the plane of the ultrasonic beam of the second ultrasonic sensor and perpendicular to the axis of the first through hole of the third movable bar, and the fourth bar is made in the form of a parallelepiped, is located on the third holder in the second through hole of the third movable bar with the possibility of movement and in such a way that the axis of the second through hole of the holder of the first sensor is located in the plane of the ultrasonic beam of the third ultrasonic sensor during its movement.