RU2823108C1 - Spinal neurosurgery instrument set for use with surgical navigation system - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medical equipment, namely to a set of instruments for spinal neurosurgery under control of a surgical navigation system. Set of instruments for spinal neurosurgery under the control of a surgical navigation system comprises an awl for opening a pedicle canal, an awl for perforation and introduction into bone structures, an awl for deepening of a pedicle canal, an awl for installation of a basic system of spheres, an attachment for a spine and a system of spheres for attachment to a spine. Awl for opening a pedicle canal is made in the form of a stiletto and includes a rod of straight cylindrical shape, which has a working part with a sharp triangular tip and a submersion limiter and a handle base with an impact surface in the end part, fixed handle with six sub-finger grooves and removable bracket for attachment of tool system of spheres, which has groove and threaded hole for screw. Awl for perforation and introduction into bone structures is made in the form of a stiletto and includes a straight conical rod, which has a working part with a flat triangular tip and a handle base with an impact surface in the end part, fixed handle with six sub-finger grooves and removable bracket for attachment of tool system of spheres, which has groove and threaded hole for screw. Awl for deepening of a pedicle canal is made in the form of a stiletto and includes a straight cylindrical rod with a transition diameter, which has a working part with a sharp triangular tip and a handle base with an impact surface in the end part, fixed handle with six sub-finger grooves and removable bracket for attachment of tool system of spheres, which has groove and threaded hole for screw. Awl for the installation of the basic system of spheres is made in the form of a stiletto and includes a rod of straight cylindrical shape, which has a working part with a sharp triangular tip and a flattened on one side handle base for installation and fixation of the handle and anvil, removable handle, in which there is a socket for installation of a rod with fixation by means of a screw and two holders for installation of a basic system of spheres at angle of 90° and 30°, and a removable anvil with a seat for the base of the handle for performing operational reception. Spine attachment in the form of a clothespin comprises two symmetrical plates with teeth, one of which is made L-shaped, has a blind hole and a screw for installing a system of spheres and is fixed, and fastening elements passed through holes of plates, providing connection of plates to each other. System of spheres for attachment to the spine made of aluminium alloy is made in the form of a Y-shaped platform, with three installed spheres fixed by a threaded connection by means of pins with an incomplete double-sided thread, and a positioning drilling on the lower part of the platform for fixing the system of spheres in the spine attachment.

EFFECT: use of the invention allows providing manipulation and stabilization of the spine during operations.

1 cl, 6 dwg

Description

The invention relates to medicine, namely to spinal neurosurgery, and is a set of instruments for use in conjunction with a surgical navigation system, and can be used in surgical interventions in the field of spinal neurosurgery. The set of instruments for spinal neurosurgery includes:

- awl No. 1;

- awl No. 2;

- awl No. 3;

- an awl for installing the basic system of spheres;

- fastening for the spine (clothespin);

- system of spheres for attachment to the spine made of aluminum alloy.

Known foreign analogues:

- navigable instruments for spinal surgery, included in the instrumentation of the Stryker NAV3 surgical navigation system (RZN 2017/5659 dated 04/06/2023);

- tools for spinal and trauma navigation, included in the instruments of the Brainlab surgical navigation system (FSZ 2012/12520 dated November 13, 2017);

- instruments for spinal surgery, included in the instrumentation of the surgical navigation system StealthStation S8 (RZN 2019/8291 dated 08/27/2021.

The disadvantage of the tools given above is the impossibility of using them with the domestic Avtoplan surgical navigation system.

The purpose of the invention is to expand the range of instruments used for spinal neurosurgery in conjunction with the domestic surgical navigation system "Autoplan".

The novelty of the design lies in its compatibility with the domestic surgical navigation system “Avtoplan” (RZN 2023/19330 dated January 12, 2023) (hereinafter referred to as “Avtoplan”).

The design of the tools included in the kit is illustrated with graphic materials

Spinal neurosurgery instruments are used during spinal surgery to manipulate and stabilize the spine.

The design of awl No. 1 is illustrated by graphic material (Fig. 1), which indicates: 1 - working part, 2 - sharp triangular tip, 3 - immersion limiter, 4 - handle, 5 - removable bracket for fastening the tool system of spheres, 6 - striking surface , 7 - base of the handle, 8 - screw, 9 - installation location of the removable bracket.

Awl No. 1 is made in the form of a stiletto and consists of a rod, which has a working part (1) and a handle base (7) for attaching the handle (4). The working part (1) has a straight cylindrical shape, which ensures the use of an instrument with a guide for spinal neurosurgery. The lower end of the working part (1) is made in the form of a sharp triangular tip (2) with a tool immersion limiter (3). The limiter is located at a distance of 10 mm from the tip (2). The end part of the base of the handle (7) is made in the form of a striking surface (6) to transfer significant force to the stylet with a surgical hammer.

At the distal end of the working part (1) there is a place for installing (9) a removable bracket (5) for fastening the instrumental system of spheres in one position. The bracket (5) has 1 groove, the mating part for which is located at the distal end of the working part (1), and a threaded hole, which allows you to fix the relative position of the bracket with its mating part using a screw (8).

The handle (4) is fixedly connected to the base of the handle (7) and has 6 finger grooves for ease of grip and holding by the surgeon.

Awl No. 1 is intended for opening the pedicular canal during surgery under the control of the Avtoplan navigation system.

Integration of the instrumental system of spheres into the awl No. 1 allows the instrument to be used in conjunction with the domestic surgical navigation system “Autoplan” with the ability to identify the structure by comparing the location of the tip of the navigated instrument with the corresponding structure on the projections of the patient’s functional study.

The design of awl No. 2 is illustrated by graphic material (Fig. 2), where it is indicated: 11 - working part, 10 - flat triangular tip, 4 - handle, 5 - removable bracket for attaching the tool system of spheres, 6 - striking surface, 7 - base handles, 8 - screw, 9 - installation location of the removable bracket

Awl No. 2 is made in the form of a stiletto and consists of a rod, which has a working part (11) and a handle base (7) for attaching the handle (4). The working part has a straight conical shape, which ensures the use of an instrument with a guide for spinal neurosurgery. The lower end of the working part (11) is made in the form of a flat triangular tip (10). The end part of the base of the handle (7) is made in the form of a striking surface (6) to transfer significant force to the stylet with a surgical hammer.

At the distal end of the working part (11) there is a place for installing (9) a removable bracket (5) for fastening the instrumental system of spheres in one position. The bracket (5) has 1 groove, the mating part for which is located at the distal end of the working part (11), and a threaded hole, which allows you to fix the relative position of the bracket with its mating part using a screw (8).

The handle (4) is fixedly connected to the base of the handle (7) and has 6 finger grooves for ease of grip and holding by the surgeon.

Awl No. 2 is intended for perforation and insertion into bone structures during surgery under the control of the Avtoplan navigation system.

Integration of the instrumental system of spheres into the awl No. 2 allows the instrument to be used in conjunction with the domestic surgical navigation system “Autoplan” with the ability to identify the structure by comparing the location of the tip of the navigated instrument with the corresponding structure on the projections of the patient’s functional study.

The design of awl No. 3 is illustrated by graphic material (Fig. 3), where it is indicated: 13 - working part, 12 - sharp triangular tip, 4 - handle, 5 - removable bracket for attaching the tool system of spheres, 6 - striking surface, 7 - base of the handle , 8 - screw, 9 - installation location of the removable bracket.

Awl No. 3 is made in the form of a stiletto and consists of a rod, which has a working part (13) and a handle base (7) for attaching the handle (4). The working part (13) has a straight cylindrical shape with a transitional diameter, which ensures the use of an instrument with a guide for spinal neurosurgery. The lower end of the working part (13) is made in the form of a sharp triangular tip (12). The end part of the base of the handle (7) is made in the form of a striking surface (6) to transfer significant force to the stylet with a surgical hammer.

At the distal end of the working part (13) there is a place for installing (9) a removable bracket (5) for fastening the instrumental system of spheres in one position. The bracket (5) has 1 groove, the mating part for which is located at the distal end of the working part (13), and a threaded hole, which allows you to fix the relative position of the bracket with its mating part using a screw (8).

The handle (4) is fixedly connected to the base of the handle (7) and has 6 finger grooves for ease of grip and holding by the surgeon.

Awl No. 3 is intended for opening and deepening the pedicular canal during surgery under the control of the Avtoplan navigation system.

Integration of the instrumental system of spheres into the awl No. 3 allows the instrument to be used in conjunction with the domestic surgical navigation system “Avtoplan” with the ability to identify the structure by comparing the location of the tip of the navigated instrument with the corresponding structure on the projections of the patient’s functional study.

The design of the awl for installing the basic system of spheres is illustrated by graphic material (Fig. 4), where it is indicated: 14 - working part, 15 - sharp tip, 16 - removable handle, 17 - screw, 18 - holder of the tool system of spheres at an angle of 90°, 19 - holder of the tool system of spheres at an angle of 30°, 20 - removable anvil, 21 - base of the handle, 22 - threaded hole, 23 - drilling.

The awl for installing the basic system of spheres is made in the form of a stiletto and consists of a removable handle (16), a removable anvil (20) and a rod, which has a straight cylindrical working part (14) and a handle base (21) for installing a removable handle (16) and a removable anvil (20). The working part has a straight cylindrical shape.

The lower end of the working part (14) is made in the form of a sharp tip (15). The base of the handle (21), flattened on one side, ensures its installation in the socket of the removable handle (16) and the removable anvil (20) without the possibility of rotating the handle (16) and the anvil (20) around the working part. The depth of the socket of the removable handle (16) and the removable anvil (20) is sufficient for reliable fixation of the needle and prevents it from breaking during the surgical procedure. On the base of the handle (21) there is a drill (23), on the removable handle (16) there is a threaded hole (22), which allows you to fix the base of the handle (21) in the socket of the removable handle (16) using a screw (17), ensuring accurate positioning of the instrumental system of spheres.

At the distal end of the removable handle (16) there are two holders for attaching the instrument system of spheres. The holder (18) ensures installation of the basic system of spheres at an angle of 90°. The holder (19) ensures installation of the basic system of spheres at an angle of 30°.

The removable anvil (20) has 4 finger grooves for ease of grip and holding by the surgeon during surgery and a striking surface for transferring significant force to the stylet with a surgical hammer.

The awl for installing the basic system of spheres is intended for rigid fixation of the basic system of spheres into the vertebral structure during the operation under the control of the Autoplan navigation system.

Integration of the basic system of spheres into the awl allows the instrument to be used in conjunction with the domestic surgical navigation system "Avtoplan" with the possibility of rigid fixation of the basic system of spheres relative to the spine by perforating the bone.

The design of the fastening for the spine (clothespin) is illustrated by graphic material (Fig. 5), where it is indicated: 26 - fixed plate with teeth, 32 - movable plate with teeth, 30 - removable guide, 24 - removable screw, 28 - blind hole for installing an instrument system of spheres for fastening to the spine (clothespin), 33 - through hole for a screw, 31 - through hole for a threaded screw, 29 - through hole for a guide, 27 - through hole for a threaded guide, 25 - screw for fastening a system of spheres.

The fastening for the spine (clothespin) is made in the form of two symmetrical plates (26) and (32) with teeth. The plate (26) has an L-shape and is stationary. The plates are connected to each other using a removable guide (30) and a removable screw (24).

On top of the plate (26) there is a blind hole for installing an instrumental system of spheres for attachment to the spine (28), which is fixed with a screw (25).

When installing the attachment to the spine, the guide (30) is passed through the through hole (29) of the plate (32) and screwed into the threaded hole (27) of the plate (26). The screw (24) is passed through the through hole (33) of the plate (26) and screwed into the threaded hole (31) of the plate (32).

When the screw (24) is screwed in, the plates come together, the teeth are tightly embedded in the spinous process of the vertebra, which ensures a stable position of the system of spheres in space.

The spinal attachment (clothespin) is intended for rigid fixation of the basic system of spheres on the spinous process of the vertebra during surgery under the control of the Autoplan navigation system.

Integration of the sphere system into the spinal mount (clothespin) allows the instrument to be used in conjunction with the domestic surgical navigation system “Avtoplan”.

The design of the system of spheres for attachment to the spine made of aluminum alloy is illustrated by graphic material (Fig. 6), where it is indicated: 34 - Y-shaped platform, 35 - threaded holes, 36 - studs, 37 - spheres, 38 - drilling.

The system of spheres for attachment to the spine is made of a U-shaped platform (34), on which there are 3 threaded holes for installing pins (36). The studs are a rod with an incomplete double-sided thread, one tip of which with a thread pitch of M4x0.7 is independently screwed into the hole (35) of the platform (34), the second tip with a thread pitch of M3x0.5 is intended for installing spheres (37). Each sphere (37) has a blind hole with a corresponding thread, which allows it to be installed on the free tip of the stud by screwing it along the thread. On the lower part of the platform there is a drill (38) for fixing the system of spheres in the spine mount (clothespin) using the screw included in the spine mount.

A system of spheres for attachment to the spine made of aluminum alloy is designed to track the position of the operated spine relative to the surgeon’s navigated instrument throughout the entire period of surgery using the Autoplan navigation system.

Below are clinical examples using the stated set of tools.

Example 1. Patient T., 61 years old, diagnosed with spondylolisthesis of the LV vertebra, degenerative stenosis of the spinal canal at the level of the LIV-LV vertebrae. Surgical intervention was performed: microsurgical decompression of the spinal canal at the level of LIV-LV vertebrae, transpedicular stabilization at the level of LIV-LV vertebrae using the "Autoplan" surgical navigation system.

In the preoperative period, a computed tomography (CT) scan of the patient's spine was performed. The results were loaded into the Autoplan software, and a 3D model of the area of interest was built. The 3D model was used to plan the installation of the selected clamps along the required trajectory.

During the surgical period, a surgical incision was made at the L3 level to access the spinous process of the vertebra and a spinal mount (clothespin) with a basic system of spheres (basis) was installed on the spinous process in a fixed position, taking into account the location of the detection stereo camera of the Autoplan APK for correct tracking of the entire basis operating period.

At the stage of perforation of the cortical layer, awl No. 1 (with a tool immersion limiter at a distance of 10 mm from the tip) was used to “mark” the access, select the correct direction and angle of placement of the future fixator. An awl No. 2 was used to form a canal in the pedicle and body of the operated vertebra. An awl No. 3 was used to deepen the channel. Awl No. 2 was used as the main one for navigation, which provided protection against getting into the spinal canal.

Intraoperatively, under the control of the Avtoplan surgical navigation system, an operation was performed for transcutaneous stabilization of one segment of the lumbosacral region with the installation of a transpedicular screw. There were no intraoperative complications during the surgical intervention.

The patient was under control for 4 days, no postoperative complications were identified.

Example 2. Patient M., 45 years old, diagnosed with a neoplasm (hemangioma) in the L5 vertebral body.

Indications for hemangioma removal with vertebroplasty of the L5 vertebra with transpedicular access under the control of the Avtoplan surgical navigation system are determined by clinical indications (pain syndrome) and the threat of pathological fracture.

In the preoperative period, the patient underwent computed tomography (CT) of the area of interest. The results were loaded into the Autoplan software, and a personalized model of the spine was built. Using a 3D model, the trajectory of instrument insertion into the vertebral body was planned.

During the surgical period, a surgical approach was made in the ilium to install an awl with a basic sphere system. The awl for installing the basic system of spheres is mounted motionless in a fixed position. Preliminary shrinkage of the system of spheres on the instrument - in the detection zone of the stereo camera of the Autoplan hardware complex for correct tracking of the basis throughout the entire operating period.

In the operating room, the patient was registered with his personalized model in the Autoplan software.

Next, using a pre-calibrated working instrument (cannulated needle for vertebroplasty), the incisions are marked. The tool calibration device is equipped with a system of reflective spheres, which makes it possible to register the position of the tool in space and obtain its visualization with a good degree of accuracy in real time.

Under the control of surgical navigation, a vertebroplasty operation was performed with the introduction of a composite material based on polymethyl methacrylate using a special needle, taking into account the adjustment of the desired direction and angle of insertion according to the virtual display in the surgical navigation system.

A control CT scan was performed after the operation.

Postoperative CT images revealed total filling of the tumor defect of the vertebra with bone cement; there was no migration of polymethyl methacrylate. The patient was discharged on the 2nd day after surgery. CT control was carried out after 6 and 12 months, and the absence of tumor recurrence was confirmed.

Taking into account the positive experience of using the invention, the set of instruments for spinal neurosurgery can be used with the Avtoplan surgical navigation system for open surgical interventions on the spine.

Claims (1)

A set of instruments for spinal neurosurgery under the control of a surgical navigation system, containing: an awl for opening the pedicular canal, made in the form of a stylet and including a straight cylindrical rod, which has a working part with a sharp triangular tip and an immersion limiter and a handle base with a striking surface in the end part , a fixedly attached handle with six finger recesses and a removable bracket for attaching the tool system of spheres, which has a groove and a threaded hole for a screw; an awl for perforation and penetration into bone structures, made in the form of a stylet and including a straight conical rod, which has a working part with a flat triangular tip and a handle base with a striking surface in the end part, a fixedly attached handle with six sub-finger recesses and a removable bracket for fastening the tooling system of spheres, which has a groove and a threaded hole for a screw; an awl for deepening the pedicular canal, made in the form of a stylet and including a straight cylindrical rod with a transitional diameter, which has a working part with a sharp triangular tip and a handle base with a striking surface in the end part, a fixedly attached handle with six finger grooves and a removable bracket for fastening a sphere tool system, which has a groove and a threaded hole for a screw; an awl for installing the basic system of spheres, made in the form of a stiletto and including a straight cylindrical rod, which has a working part with a sharp triangular tip and a handle base flattened on one side for installing and fixing the handle and anvil, a removable handle in which a socket is made for installation a rod with a screw fixation and two holders for installing the basic system of spheres at an angle of 90° and 30°, and a removable anvil with a socket for the base of the handle for performing an operative technique; fastening for the spine in the form of a clothespin, containing two symmetrical plates with teeth, one of which is L-shaped, has a blind hole and a screw for installing a system of spheres and is stationary, and fastening elements passed through the holes of the plates, ensuring the connection of the plates with each other ; system of spheres for attachment to the spine made of aluminum alloy, made in the form of a Y-shaped platform, with three installed spheres, secured by a threaded connection using studs with partial double-sided threads, and a positioning drill on the bottom of the platform for fixing the system of spheres in the mount for the spine .