RU2351375C1 - Method of compression fracture treatment - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to medicine, in particular to neurosurgery, traumatology and orthopaedics and can be used for spine reconstruction. Balloon is introduced into injured vertebral body and vertebral body height is restored by its blowing. Zone and direction of balloon blowing are limited in direction opposite to compression which ensures its stretching in zone of injured section. After filling cavity bone-substituting material is compacted by contact impact of ultra-sound vibrations. Zone and direction of balloon blowing are restricted by placing it inside rigid tube on its distal end, which is made blind, outlet for balloon being located on lateral surface. Tube is placed with outlet directed to region of injured vertebral body compression. Rigid tube wall opposite to outlet serves as support, so that being placed on it balloon is blown only towards one side - opposite to support. Rigid tube with outlet for balloon must be placed in such way that direction of balloon blowing coincides with direction opposite o compression. Contact impact realised is by ultra-sound vibrations with frequency 1-2 MHz. Impact is realised by means of ultra-sound radiator in form of ball.

EFFECT: method allows to eliminate post-operation complications.

4 cl, 1 ex, 9 dwg

Description

The invention relates to medicine, in particular to neurosurgery, traumatology and orthopedics, and can be used for reconstruction of the spine.

Various surgical puncture methods for treating compression fractures of the vertebral bodies are known.

A known method of ultrasonic osteosynthesis for the treatment of bone damage, which consists in connecting bone fragments by fusion, plastic deformation of the parts to be welded, in which a molecular connection occurs between them. The essence of ultrasonic bone welding is that the electrical vibrations generated by a special generator are fed to the winding of a magnetostrictor that converts electrical vibrations into mechanical ones. These vibrations are transformed using a waveguide. Having opened access to the broken bones, they are compared, connecting either “butt-to-butt”, or using a bone homotransplant. Before welding, a layer of liquid plastic, which plays the role of solder, is applied to the connected bone fragments. Ultrasonic vibrations, reaching the section of two bone fragments filled with solder, act on them and form a strong welding joint. Ultrasonic welding can be used to restore bone integrity in fragmented, multi-fragmented fractures and to recreate bone tissue in order to fill defects in bones after resection of the diaphysis during or after removal of the articular ends of the bones (Orthopedics, traumatology and prosthetics, 1970, No. 3, p. 34 -37).

However, the application of this method is possible only in open areas of bone tissue, i.e. wide surgical access required. In addition, when using this technique, the development of osteonecrosis cannot be excluded, which subsequently can cause pain and may lead to the need for repeated surgical treatment.

Recently, such an effective and minimally invasive method of surgical treatment of primary and metastatic lesions with the threat of a pathological fracture, as percutaneous (puncture) vertebroplasty, first proposed by the French doctor H.Deramond et al. In 1984, has also gained popularity. In addition, this method is used for osteoporosis and associated compression vertebral fractures. The essence of the procedure is to strengthen the vertebral body with the help of specially created medical cements.

The technique of percutaneous vertebroplasty is as follows: a mixture consisting of bone cement, antibiotic and contrasting material is introduced into the vertebral body through a special needle (trocar) under fluoroscopic, CT (computed tomography) or MR (magnetic resonance imaging). Bone cement consists of two parts, a solid (powder) and a liquid component, the mixing of which starts the polymerization reaction and the gradual hardening of the cement. Stiffening, cement strengthens the vertebra, which not only effectively treats the effects of compression fractures of the vertebral bodies due to osteoporosis, but is also used to treat pain caused by hemangiomas of the vertebral bodies or tumor metastases in the spine (E.G. Pedachenko, S.V. Kushchaev, Puncture Veteroplasty, A.L.D., Kiev, 2005).

However, the method of percutaneous vertebroplasty, which stops kyphotic deformity of the spine, does not smooth out the compressed vertebral body.

A known method of kyphoplasty, including restoring the height of the vertebral body due to the formation of a cavity and subsequent introduction of bone cement into the cavity. The restoration of the height of the vertebra is carried out by the metered extension of the rectangular platform of a special device, the device being introduced into the body of a broken vertebra through the channel formed for it, which is performed in the area of the leg. The device comprises a handle and a blindly terminating tube coaxially connected to the handle with an outer surface diameter of up to 5 mm and with a decentralized internal channel having a bend at an angle of 30-45 °, while a rectangular hole is located at the distal end of the tube, on the opposite side from the internal channel, and inside the handle and tube there is a movable rod with a fine thread at the proximal end, which is screwed into a sleeve equipped with a handle for rotation, and the distal end of the rod is connected to a short rod having a rectangular platform at the distal end mounted with the possibility of extension and corresponding to the dimensions of the rectangular hole (see RF patent for the invention No. 2311149, IPC АВВ 17/70).

However, despite the apparent advantages of this method, it has a significant drawback that casts doubt on its use. This is associated with a high risk of jamming when bone tissue gets under a rectangular platform. As a result of a possible jamming, removal of the device from the vertebral body will be extremely traumatic.

The closest in technical essence to the proposed one is the method of balloon kyphoplasty, which consists in the puncture introduction of special cylinders into the affected vertebral bodies, when inflated, a certain restoration of their height occurs. Subsequently, bone cement fixes the corrected deformation by the standard technique for puncture vertebroplasty. Carrying out such multilevel manipulations provides a significant straightening of the spine and bringing it to the normal axis. At its core, kyphoplasty is a modified vertebroplasty. An important advantage of balloon kyphoplasty, in addition to eliminating the existing wedge-shaped deformation, is also a decrease in the risk of extravertebral outflow of bone cement (E.G. Pedachenko, S.V. Kushchaev, Puncture vetroplasty, A.L.D., Kiev 2005, p.475-483) .

The disadvantage of the method of balloon kyphoplasty is the lack of directional effects on the compressed portion of the vertebral body, the expansion of the balloon may occur unevenly and not in the desired direction, while the likelihood of displacement of bone fragments into the spinal canal is not excluded.

The task to which the invention is directed is to restore the height of the compressed vertebral body and its supportability.

The technical result consists in increasing the efficiency of kyphoplasty with the maximum exclusion of the displacement of bone fragments into the spinal canal.

This problem is solved by the fact that in the method of balloon kyphoplasty, including introducing a balloon into the damaged vertebral body and restoring the height of the vertebral body by inflating it, removing the balloon from the formed cavity, filling the cavity with bone substitute material, according to the solution, the zone and direction of balloon inflation are limited in the opposite direction compression, ensuring its expansion in the area of the damaged area, after filling the cavity, the bone substituting material is sealed with a contact action ultrasonic vibrations.

The zone and direction of balloon inflating is limited by placing it inside a rigid tube at its distal end, which is plugged, having an outlet for the balloon on the side surface, while the tube is installed with an outlet directed to the compression region of the damaged vertebral body. In this case, the wall of the rigid tube opposite the outlet is a support, so that, being located on it, the balloon inflates only in one direction opposite to the support. A rigid tube with an outlet for the cylinder must be placed so that the direction of inflation of the cylinder coincides with the direction opposite to compression. This will eliminate the impact on the intact areas and thereby prevent the displacement of bone fragments into the spinal canal.

Contact exposure is carried out by ultrasonic vibrations with a frequency of 1-2 MHz.

The impact is carried out by an ultrasonic emitter in the form of a ball. The contact action of ultrasound on the cavity after it is filled with bone-substituting material and removal of the tube with the balloon promotes high-quality cavity filling, strong adhesion of bone fragments, eliminates the risk of plastic material spreading into the spinal canal, and also stimulates bone tissue regeneration processes.

Thus, the technical result of the proposed method is achieved. The invention is illustrated by drawings, figure 1 shows an example of a device for restoring the height of the vertebral body, allowing to inflate the balloon in a given direction, figure 2 - ultrasonic seal bone replacement material, figure 3 shows a compression fracture of the vertebral body; figure 4 shows the introduction of a device for restoring the height of the body of a damaged vertebra, figure 5 - restoration of the height of the body of the vertebra, figure 6 - formed cavity; Fig.7 - filling the formed cavity in the vertebral body with bone substitute material, Fig.8 - ultrasonic compaction of bone substituting material, Fig.9 - expanded vertebral body with a filled cavity after compaction with ultrasound, where

1 - rigid tube;

2 - cylinder in non-working and working positions (dash-dot);

3 - outlet;

4 - the distal end of the tube;

5 - a flexible tube;

6 - a device for pumping air;

7 - connecting element;

8 - - electro-acoustic transducer;

9 - sound guide;

10 - ultrasonic emitter;

11 - back load;

12 - dielectric gasket;

13 - pressure clutch;

14 - through coaxial hole;

15 - the first conclusion to the generator of ultrasonic vibrations;

16 - terminal for the second output to the generator of ultrasonic vibrations;

17 - tubular conductor;

18 - leg of the vertebra;

19 - the root of the arc of the vertebra;

20 - damaged vertebral body;

21 - zone of greatest compression;

22 - formed cavity in the body of the damaged vertebra;

23 - bone replacement material.

A device for restoring the height of the vertebral body contains a rigid tube 1 made, for example, of medical steel with an open proximal end with a length of 15 cm and a diameter of 5 mm. A balloon 2 is placed inside the tube at its distal end 4. The balloon may be made, for example, of a biocompatible elastic polymer material. By means of a flexible tube 5 made of rigid polymeric material, the cylinder is connected to a device for pumping air 6 in the form of a piston through a connecting element 7. The dimensions of the tube 5 in a particular device were: length 14 cm and diameter 1.5 mm. In the rigid tube 1, an outlet 3 is made on the side surface in the form of a recess or window. Inside the tube 1 in the area of the outlet 3 is located the cylinder 2. The dimensions of the outlet are proportional to the corresponding dimensions of the cylinder.

The ultrasonic compactor of bone substituting material (figure 2) contains an electro-acoustic transducer 8 and a sound guide 9 with an ultrasonic emitter at the distal end 10. The sound waveguide 9 is made of stainless medical steel 20 cm long, conical in shape, with a diameter in the proximal section to 15 mm with a decrease up to 5 mm at a distance of 50 mm from the proximal end and further up to 2 mm to a spherical emitter 10 with a diameter of 4 mm at the distal end. At the proximal end of the ultrasonic sound guide 9, an electro-acoustic transducer 8 is rigidly fixed in the form of a piezoceramic plate with a metal coating. On the other hand, the piezoceramic plate is rigidly connected to the back load 11 in the form of a massive metal element of arbitrary shape, connected, in turn, to the dielectric gasket 12. The gasket 12 is fixed by a pressure clutch 13 mounted on the outside of the sound guide 9. In the center of the dielectric gasket 12 and in the pressure sleeve 13 from the proximal end there is a coaxial hole 14 for the first output 15 to the ultrasonic vibrator (not shown), and on the outer wall of the pressure sleeve 13 Credited terminal to the second terminal 16 to said generator.

The method is implemented as follows.

The patient is placed on the operating table in a position on the stomach. Marking the surgical field, where they indicate the guidelines for the introduction of the tubular conductor 17 to bring the device (figure 1) to restore the height of the vertebral body. After that, under X-ray control, under local anesthesia, a tubular conductor 17 with a trocar inside is inserted through the leg 18 and the root of the arch 19 into the body of the damaged vertebra 20 into the zone of greatest compression 21. The diameter of the tubular conductor is selected depending on the size of the legs and root of the vertebral arch (from 4 to 7 mm). After this, the trocar is removed, and the tubular conductor 17 remains in the body of the vertebra. Then the tubular conductor 17 is pulled back to the root of the arc 19 and through it, a device for restoring the height of the vertebral body is installed in the channel formed in the vertebral body (Fig. 1). Under X-ray control, the device is installed so that the outlet 3 is in the area of greatest compression and goes in his direction. After that, using a piston 6, air is metered into the cylinder 2. In this case, the cylinder 2 is blown out of the window 3 in the direction of compression, and the opposite wall of the rigid tube 1 serves as a support and prevents the balloon 2 from inflating in an unnecessary direction.

The process of expanding the balloon 2 and, accordingly, expanding the vertebral body, is controlled using an x-ray machine. The cylinder has radiopaque marks, which are well visualized on the screen of the electro-optical converter (not shown in the drawing). Under the control of fluoroscopy, the choice of the direction of balloon inflation and its final location in the vertebral body are determined. After restoring the height of the vertebral body, the piston 6 is disconnected, the balloon 2 is deflated and removed. Then, the formed cavity 22 in the vertebral body through the tubular conductor 17 is tightly filled with bone-substituting material (bone cement) 23. After the cavity 22 is finally filled through the tubular conductor 17, the ultrasonic emitter 10 of the bone-replacing material ultrasonic sealant (FIG. 2) is brought into contact with the contact bone-substituting material 23. Contact ultrasound is applied to the filled cavity 22 for (10-30) seconds with the following parameters: amplitude of oscillations of the emitter of the duct 9 A = (30-50) μm, the frequency of ultrasonic vibrations is from 20 to 40 kHz, the intensity of the vibrations is from 1 to 8 W per 1 cm ² , then the sound guide 9 is removed and an aseptic dressing is applied in the area of the trocar injection and the patients are left on a few minutes in a stationary state. The parameters of ultrasonic vibrations are determined by calculation based on the speed of sound propagation in the material of the sound guide 9, the geometric dimensions of the emitter 10 and the particle mass of the bone-substituting material.

Clinical example

Patient F., 42 years old, was admitted to the Department of Traumatology and Orthopedics with a diagnosis of:

Closed uncomplicated injury of the lumbar spine with compression fracture of the LI vertebra.

The patient received an injury as a result of a fall from a height of 4 meters onto his back in the flexion position. From the scene, the patient was taken to the hospital 6 hours after receiving the injury.

The patient underwent X-ray and computed tomography (CT) examination, which revealed a compression fracture of the LI vertebral body with a wedge index of 0.6 and an angle of kyphotic deformation of 18 °, no displacement of bone fragments towards the spinal canal was revealed. In the neurological status of motor and sensory deposition was not detected. Locally, on palpation, marked pain at the level of ThXII-LI of the spinous processes, extinction of the spinous process of the ThXII vertebra, are noted. The patient was put on a hammock with loads of 8 kg on each side. Prescribed conservative symptomatic therapy. After three days, the patient underwent X-ray control, which revealed that the degree of compression of the LI vertebral body remains almost at the same level.

On the fourth day after the injury, the patient underwent surgical treatment: transcutaneous transpedicular balloon plastic of the LI vertebra body with ultrasound compaction of osteoplastic material.

The operation was performed as follows

The patient was laid on an operating table on his stomach with rollers under the chest and pelvis. Produced standard processing of the surgical field from the level of the shoulder to the sacrum. Local anesthesia was performed with a 1% lidocaine solution in layers according to the future conductor route in the form of a spoke and a balloon tube in the projection of the root of the arch of the LI vertebra on the left. Next, the conductor was introduced and positioned under fluoroscopic control to the root of the arch of the LI vertebra, then the conductor was inserted to the border of the front and middle third of the vertebral body (2/3 of the distance from the back wall and 1/3 of the front wall of the vertebral body) towards the midline the area of greatest compression of the body. A conduit with a diameter of 6 mm was inserted through the conductor into the LI body, through which a device was introduced to restore the height of the vertebral body (Fig. 1) so that the exit window was located directly below the compression zone. After that, the vertebral body height was restored to normal sizes and balloon 2 was removed. The cavity formed in the vertebral body was filled with osteoplastic material in the form of small granules mixed with autoblood and contrast substance omnipack in a volume of 2 cm ³ . Then, a sound guide with a spherical emitter at the end is introduced into the cavity filled with osteoplastic material through the tube. An ultrasonic effect was made on the contact cavity filled with osteoplastic material for 2 minutes with the following parameters: amplitude of oscillations of the working end of the waveguide A = 1.2 nm, frequency of ultrasonic vibrations - 1.5 MHz, vibration intensity - 2 W per 1 cm ² . During X-ray inspection, a dense filling of the cavity with bone-plastic material was noted. After that, the sound guide and the tubular conductor are removed, an aseptic sticker is applied. The next day, the patient was transferred to an upright position. There is no pain syndrome. On the control radiographs, the height of the LI vertebra is restored, there is no kyphotic deformation. The patient is equipped with a semi-rigid corset, was discharged for outpatient treatment. With repeated x-ray examination after 6 months, no correction loss was detected.

On control radiographs of the vertebral bodies, an almost complete restoration of the normal height of the body of the broken vertebra and the formation of strong bone tissue were found without disturbing the natural processes of bone tissue regeneration.

Thus, the proposed method for the treatment of fractures of the spine increases the effectiveness of treatment, improves the quality of the bone mantle in the vertebral cavity and reduces the time of postoperative hospital stay.

Claims (4)

1. The method of balloon kyphoplasty, including introducing a balloon into the damaged vertebral body and restoring the height of the vertebral body by inflating it, removing the balloon from the formed cavity, filling the cavity with bone substitute material, characterized in that the zone and direction of balloon inflation are limited in the opposite compression direction, providing its straightening in the area of the damaged area, after filling the cavity, the bone-substituting material is compacted by the contact action of ultrasonic vibrations. 2. The method according to claim 1, characterized in that the zone and direction of inflation of the balloon is limited by placing it inside a rigid tube at its distal end, which is muffled, having an outlet for the balloon on the side surface, the tube being installed with an outlet directed to compression area of the damaged vertebral body. 3. The method according to claim 1, characterized in that the contact action is carried out by ultrasonic vibrations with a frequency of 1-2 MHz. 4. The method according to claim 1, characterized in that the exposure is carried out by an ultrasonic emitter in the form of a ball.

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