RU2437629C1 - Method of balloon kyphoplasty of vertebra - Google Patents

Abstract

FIELD: medicine. ^ SUBSTANCE: invention relates to medicine, namely to vertebrology. Into injured body of vertebra dilatation balloon is introduced under apparatus visual control. By unfolding dilatation balloon by liquid under pressure height of vertebra body is restored. After that dilatation balloon is blown out and removed from formed cavity inside vertebra and formed cavity is filled with bone-substituting material. Additionally, delicate impact on bone tissue during height recovery is performed by transmitting translational jerk-oscillatory movements to dilatation balloon. ^ EFFECT: method makes it possible to ensure maximally possible restoration of height of injured vertebra body. ^ 2 cl, 4 dwg

Description

The invention relates to medicine, in particular to traumatology, orthopedics, neurosurgery and vertebrology, and can be used for minimally invasive surgical intervention in the treatment of compression fractures of the vertebral bodies against osteoporosis or traumatic injuries, allowing to restore the height of the vertebral body lost due to kyphotic deformation and strengthen it with using bone-substituting material pumped into the vertebral body [Pedachenko EG, Kushchaev SV Puncture vertebroplasty / A.L.D., Kiev, 2005, p.25].

There are various surgical puncture methods for treating compression and compression-comminuted fractures of the vertebral bodies.

Known methods of puncture vertebroplasty - a minimally invasive method for stabilizing and strengthening damaged vertebral bodies using bone-substituting materials.

[Pedachenko E.G., Kushchaev S.V. Puncture vertebroplasty / A.L.D., Kiev, 2005.517 p .;

Deramond N., Depriester C., Galibert P., Le Gars D. Percutaneous vertebroplasty with polymethyl methacrylate. Technique, indicatios, and results // Radiol Clin North AM. - 1998; 36: 533-546;

Mathis J.M. Barr J.D. et al Percutaneous vertebroplasty: a developing standard of care for vertebral compression fractures. [Review.] // AJNR. - 2001; 22: 373-381].

A bone-substituting material is introduced into the vertebral body through the rod under visual visual control, then it solidifies, thus restoring the supporting ability of the vertebral body.

However, this method of puncture vertebroplasty does not provide restoration of the height of the compressed vertebral body.

Also known is the "Method of kyphoplasty" [RU patent for the invention No. 2311149, filing date 05/11/2006, publ. November 27, 2007], in which the height of the vertebral body is restored by dosed extension of the rectangular platform of the device. Then, the formed cavity is filled with bone-substituting material, in particular bone cement.

The disadvantage of this technique is the high risk of jamming of the mechanism of the claimed device (shown in the same patent, along with the method) when bone tissue gets under a rectangular platform - one of the main mechanisms of the method, lifting and restoring the height of the vertebra. As a result of a possible jamming, removal of the device from the vertebral body will be traumatic.

The closest analogue to the claimed invention is the "Method for the treatment of vertebral fractures" [RU patent for invention No. 2351375, filing date 12/25/2007, publication date 04/10/2009], including the introduction of a dilated balloon into the damaged vertebral body, restoration of height the vertebral body by expanding the dilatation balloon with liquid, deflating and removing the balloon from the formed cavity, then filling the cavity with bone-substituting material and sealing the latter with ultrasound contact.

However, this method does not exclude insufficient restoration of the height of the vertebral body, due to the inability at a given pressure of the liquid to further expand the balloon and further seal the spongy tissue along its periphery.

The task of the invention is to achieve the highest possible restoration of the height of the body of the damaged vertebra.

The essence of the claimed invention lies in the fact that in the method of balloon kyphoplasty of the vertebra, in which a dilatation balloon from an elastic tensile material is injected into the damaged vertebral body under hardware visual control, the vertebral body height is restored by straightening the dilatation balloon with liquid under pressure, blow off and remove the dilatation balloon from formed cavity inside the vertebra, fill the formed cavity with bone substitute material, while restoring the height of the vertebral body by spreading it with the liquid, a delicate effect on the bone tissue is additionally performed by communicating translational jerk-vibration movements to the dilatation balloon.

In addition, the claimed method of balloon kyphoplasty of the vertebra with the above features, in which the cavity is filled with bone-substituting material, without waiting for the complete dilatation of the dilatation balloon and its exit from the formed cavity, by introducing the bone-substituting material into one vacated zone from deflating the balloon after another.

The technical result of the claimed invention consists in an attempt to implement additional opportunities in the treatment of compression fractures of the vertebral bodies by introducing a technique not described in the literature for balloon kyphoplasty, namely, an additional delicate effect on bone tissue by translational jogging of the dilated balloon, primarily in fracture areas.

These jerky oscillatory movements make it possible to overcome compression, which impedes the complete restoration of the vertebral body height, and contributes to its expansion, as well as to denser packing of vertebral fragments around the formed cavity.

The additional bone tissue compaction due to the “thumping” of the dilatation balloon prevents the outflow of bone-replacing material when it is pumped outside the vertebral body, and also increases the support ability. last one.

In addition, increases in supportability are achieved by another improvement claimed in this method. The cavity is filled with bone-substituting material without waiting for the complete dilatation of the dilatation balloon and its exit from the formed cavity. With this technique, parts of the cavity that are released when the balloon is deflated are gradually filled with bone-substituting material, ensuring its uniform distribution and eliminating the risk of the formation of unfilled microcavities.

The invention is illustrated Fig.1-4,

where in Fig.1 - the vertebral body with a compression fracture;

figure 2 is an illustration of the restoration of the height of the vertebral body by expanding the balloon;

figure 3 is an illustration of filling the formed cavity in the vertebral body with bone-substituting material;

figure 4 - the body of the vertebra with a cavity filled with bone replacement material.

In Fig.1-4, positions 1-6 are indicated:

1 - tubular conductor;

2 - dilatation cylinder;

3 - carrier catheter tube;

4 - formed cavity;

5 - bone replacement material;

6 - needle.

The method is implemented as follows.

A patient with a compression fracture of the vertebral body (Figure 1) is placed on the operating table in the supine position. Mark the surgical field, where they indicate the guidelines for conducting traspedicular puncture of the damaged vertebra. Under hardware visual control - X-ray and / or computed tomography and under local anesthesia, the tubular conductor 1 with the rod inside is inserted through the leg and the root of the arc of the damaged vertebra into his body. After this, the rod is removed, and the tubular conductor 1 is left in the vertebral body. Then the tubular conductor 1 is pulled back to the root of the arc and through it into the formed channel the dilated balloon 2 of elastic tensile material located on the supporting catheter tube 3 is inserted into the damaged vertebral body 3. The dilated balloon 2 has X-ray contrast marks. Using the devices of hardware visual control, the final location of the dilatation balloon 2 in the body of the damaged vertebra is determined.

Then restore the height of the vertebral body. To do this, straighten the dilatation balloon 2 injected with liquid pressure. As the latter straightens, the shape of the damaged vertebral body is corrected, the kyphotic deformation is corrected, bone spongy tissue is compacted and bone fragments are straightened, forming a cavity.

In case of incomplete restoration of the vertebral body height, a delicate impact on the bone spongy tissue is additionally performed by communicating translational jerk and vibration movements to the dilatation balloon 2. In the course of this impact, pushing is performed with a small amplitude in the direction of the bone spongy tissue dilated balloon 2, which was compacted by the initial expansion. These tremors make it possible to overcome compression, which impedes the full restoration of the height of the vertebral body, and to straighten bone fragments. At the same time, additional compaction of bone spongy tissue occurs. Using hardware visual control, the degree of restoration of the vertebral body height is monitored.

After complete correction of kyphotic deformation, fluid injection is stopped. Next, the claimed method is continued as follows. The dilatation balloon 2 is blown off and removed from the formed cavity 4. Then, bone-substituting material 5 is injected using a needle 6.

Or the continuation of the method lies in the fact that parts of the cavity 4 that are released when the balloon is deflated are gradually filled with bone-substituting material 5, ensuring its uniform distribution and eliminating the risk of the formation of unfilled microcavities.

After filling the cavity, the balloon is removed, the bone substituting material 5 is left to solidify or compacted, for example, by ultrasonic contact.

After some time, the bone substitute material hardens and provides supportability of the damaged vertebra.

Clinical example.

Patient D., 58 years old, was admitted to the Department of Traumatology with a diagnosis of:

“Disharmonious osteochondropathy. Secondary postmenopausal osteoporosis complicated by a compression fracture of the LI vertebral body with a wedge index of 0.65 and a 12 ° angle of kyphotic deformation. ”

The patient excludes the fact of injury, but 2 days before going to the hospital when lifting weights (a bucket of water) I felt a sharp pain in the thoracolumbar spine. The pain syndrome did not go away, so the patient was forced to contact a medical institution.

Upon admission to the hospital, the patient was examined:

- X-ray examination, in which a compression fracture of the LI vertebral body with a wedge index of 0.65 and an angle of kyphotic deformation of 12 ° was detected;

- computed tomographic examination, in which displacement of bone fragments towards the spinal canal was not detected and marked osteoporosis was noted;

- MRI study, in which a violation of the integrity of the spinal canal and its contents is not detected;

- densitometric study, in which it is noted that the mineral density of bone tissue of the lumbar spine. (T-test = -3.5-5SD) and proximal femur (T-test on the left = -2.5SD, on the right = -2.7SD), which corresponds to postmenopausal osteoporosis with a predominant loss of bone mass in the lumbar spine.

In the neurological status of motor and sensory deposition was not detected. Locally, on palpation, marked pain at the level of ThXII-LI-LII of the spinous processes is noted.

The day after admission to the hospital, the patient underwent surgical treatment according to the method of balloon kyphoplasty of the vertebral body LI claimed in this application.

During the operation, the patient was laid on the operating table in the supine position. They performed standard processing of the surgical field from the shoulder to sacrum level and performed local anesthesia with 0.5% novocaine layer by layer according to the future puncture route in the projection of the root of the arch of the LI vertebra on the left. Next, the tubular conductor was introduced and positioned under fluoroscopic control to the root of the arch of the LI vertebra, then the conductor was introduced to the border of the anterior 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 to the area of greatest compression of the body. A dilatation balloon was introduced into the LI body through a tubular conductor. Under radiological control, the dilatation balloon was straightened with liquid under pressure, while a slight restoration of the height of the vertebral body was noted. An additional translational thrust-vibrational effect was made on the walls of the formed bone cavity by the distal part of the dilatation balloon, as a result of which it was possible not only to restore the vertebral body height to normal sizes, but also to achieve bone compaction along the periphery of the formed cavity.

During gradual deflation of the dilatation balloon, the cavity formed in the vertebral body was filled with bone-substituting material in the form of small granules mixed with autoblood and contrast agent omnipack in a volume of 2 cm ³ . In this case, no extravertebral outflow of bone substituting material was detected.

During X-ray inspection, dense filling of the cavity with bone-plastic material was noted. After this, the conductor was removed, an aseptic sticker was placed on the puncture site. The next day, the patient was transferred to an upright position. There was no pain. On control radiographs, a complete restoration of the height of the LI vertebral body and correction of kyphotic deformity were noted. With repeated x-ray examination after 6 months, no correction loss was detected.

Claims (2)

1. The method of balloon kyphoplasty of the vertebra, in which a dilatation balloon from an elastic tensile material is injected into the damaged vertebral body under hardware visual control, the vertebral body height is restored by straightening the dilatation balloon with liquid under pressure, the dilatation balloon is blown and removed from the formed cavity inside the vertebra, and the formed the cavity with bone-substituting material, characterized in that when restoring the height of the vertebral body through its expansion Tew further comprising a delicate effect on bone tissue by posts Tolchkovo translational vibrational movements dilatation balloon. 2. The method of balloon kyphoplasty of the vertebra according to claim 1, characterized in that the cavity is filled with bone-substituting material, without waiting for the dilatation balloon to be completely deflated and exited from the formed cavity, by introducing the bone-replacing material into one vacated zone from deflating the balloon after another.

Images