CN100434046C - A device for treating vertebral body compression fractures - Google Patents

Abstract

The invention discloses a device for treating vertebral compression fractures. The device is composed of an implantable nickel-titanium temperature memory alloy orthopedic resetter and a special matching auxiliary system. The head, the tail and the body of the arc-shaped memory alloy wire are composed of three parts; the auxiliary system consists of a puncture guide needle, a graduated puncture drill with the above-mentioned puncture guide needle, a working sleeve, a protective sleeve, a pusher, and a pusher. The orthopedic reducer can be shaped into a tubular shape under ice water conditions, and after being implanted into the vertebral body through a thin working cannula through the pedicle, it can be reconstructed under body temperature conditions, and the fractured vertebral body can be affected. supporting role. The supporting auxiliary system can complete the positioning, puncture and drilling of the pedicle at one time, reducing the puncture procedures and X-ray perspective. The invention can treat vertebral body compression fractures with one-time minimally invasive surgery, avoiding secondary surgery.

Description

A device for treating vertebral body compression fractures

technical field

The invention relates to a medical appliance, in particular to a device for treating vertebral body compression fractures.

Background technique

Vertebral compression fractures of the spine are a common disease, and there are different natures and types of vertebral fractures in different ages. The traditional treatment of vertebral compression fractures is the posterior short-segment pedicle screw technique based on the three-column theory of the spine. The screw is implanted into the normal pedicle adjacent to the upper and lower sides of the affected vertebra. The "stretch-compression" principle of the peripheral ligaments of the body was used to reset the affected vertebra; the internal fixation was removed after the fracture healed, and two operations were performed.

Posterior pedicle screw technology has been clinically used for more than 20 years and has received good clinical results. But there are also many problems, such as fixing the normal vertebral body and at least two adjacent intervertebral discs; the broken nail of the screw itself; the correction degree is lost after the screw is removed; senile osteoporotic vertebral body is more prone to traumatic vertebral compression fractures and fragility fractures, resulting in pain and kyphosis; pedicle screws cannot fix the osteoporotic vertebral body and are prone to regression. Nail and more.

Spinal vertebroplasty is to directly inject bone cement into the diseased vertebral body, which produces good pain relief effect clinically, and is gradually applied to clinical treatment of vertebral body pain diseases. The thin bone cement is directly injected into the diseased vertebral body through a catheter. Because the bone cement for vertebroplasty needs to be injected into the vertebral body in a thin state, it is easy to cause the bone cement to leak, enter the periphery of the vertebral body, the spinal canal, and blood vessels, and even enter the circulatory system to other parts of the body, resulting in complications such as embolism and compression of the spinal cord. .

Kyphoplasty is developed on the basis of vertebroplasty. An expandable resin balloon is used to expand the diseased vertebral body. Bone cement can be injected in the lump stage, which reduces the pressure of injecting bone cement and greatly It reduces the complications of bone cement vertebral leakage, and at the same time, produces a certain reduction effect on the fractured vertebral body. However, the high pressure-resistant balloon used in kyphoplasty is made of special materials, imported from abroad, and the cost is high; a contrast agent is required during use; the balloon is in danger of being punctured by bone in the vertebral body, which may cause the contrast agent to leak into the vertebral body. Blood vessels and spinal canal.

At present, the clinical percutaneous pedicle puncture operation is divided into steps, and the operation is cumbersome. The C-arm X-ray machine monitors it multiple times, which increases the X-ray exposure of the operator.

Contents of the invention

The purpose of the present invention is: aiming at the problems existing in the current clinical treatment technology of vertebral body compression fractures, combined with the deficiencies in the material and operation of kyphoplasty, and according to the pedicle theory, provide a vertebral body compressibility without neurological symptoms. The treatment of fractures, pathological fractures, and senile vertebral osteoporosis provides a kind of orthopedic reset device composed of nickel-titanium temperature memory alloy that can be permanently implanted in the vertebral body and a special auxiliary supporting system for the treatment of vertebral body. Device for compressing fractures.

The technical solution of the present invention is: a device for treating vertebral body compression fractures, which is composed of an implantable nickel-titanium temperature memory alloy orthopedic resetter and a special supporting auxiliary system, wherein the orthopedic resetter is composed of memory alloy wires The head, the tail and the body of the curved memory alloy wire are composed of three parts; the supporting auxiliary system consists of a puncture guide needle, a graduated puncture drill with the above-mentioned puncture guide needle, a pusher, a working sleeve, and a protective sleeve , injection tube and injection rod; the orthopedic reducer can be shaped into a tubular shape in ice water, and after being implanted into the vertebral body through a thin working cannula through the pedicle, it can be restored at body temperature and the orthopedic reset After the memory alloy wire in the body is expanded, a certain volume space is formed, and there are gaps between each memory alloy wire to form a card slot; the orthopedic reset device can generate tension in the vertebral body, and the fragmented, loose, and collapsed vertebral body The cancellous bone is distracted and reduced, and the geometry of the vertebral body is restored.

The orthopedic resetter described in the present invention is made of nickel-titanium temperature memory alloy as a whole, and the center of the head of the orthopedic resetter has a guide needle hole through which a guide needle can be punctured; the body is composed of 4 to 8 memory alloy wires, And according to the different forms of vertebral fracture compression in different parts, different specifications are designed, the shape is spherical or hemispherical, rugby ball or gourd-shaped; the tail is a hollow connecting tube, which can be matched with the top of the special pusher.

The puncture drill in the supporting auxiliary system described in the present invention has a flat sharp opening cone at the top, a self-tapping cone with equal diameter and a three-lobed groove drill, and a millimeter-level scale rod at the tail end, which is convenient for judging the puncture during the operation process. Depth: There is an eccentric hole in the puncture drill, which can accommodate the puncture guide needle. The eccentric hole is designed to be more conducive to the opening of the vertebrae; the design of this puncture drill can complete the drilling of the pedicle at one time, and it is a working sleeve for entering the vertebral body. The tube provides a path.

The working sleeve in the supporting auxiliary system is a hollow tube, which can accommodate and shape a tubular orthopedic resetter under ice water.

The pusher in the supporting auxiliary system is composed of a rod and a handle. There is a small ball and a groove at the top of the rod, which is connected with the tail of the orthopedic resetter; the center of the pusher has a guide needle hole through which a guide needle can be punctured.

The protective sheath in the matching auxiliary system is a hollow tube, which can be accommodated through the puncture drill and used to protect the skin and muscles.

The injection tube in the supporting auxiliary system is a hollow tube through which bone cement or other biological glue materials can be poured into the orthopedic reducer through the injection rod.

Nickel-titanium temperature memory alloy has been widely used clinically, and is safe, non-toxic and non-rejecting in vivo. The orthopedic resetter described in the present invention is in the glued state inside the vertebral body, stays still in the vertebral body, does not wear out, and does not generate debris; it can be detected by X-ray, which is convenient for X-ray monitoring during operation; it can withstand MRI inspection.

Along with the research on biological filling materials, the implantation of the orthopedic reducer involved in the present invention can provide a new space for further clinical treatment of vertebral compression fractures in young adults.

The implantable nickel-titanium temperature memory alloy orthopedic resetter described in the present invention itself has a certain anti-pressure effect. After it expands in the vertebral body, there is a certain distance between the memory alloy wires, which can make the perfused bone cement and Filling materials such as biological colloid and cancellous bone interpenetrate and fix the fractured vertebral body together with perfused bone cement and other colloidal biomaterials to strengthen the mechanical properties of the compressed fractured vertebral body, while retaining the original vertebral body and vertebral body. Kyphoplasty has good pain relief and minimally invasive effects, and has the advantage of achieving the purpose of treatment through one-time minimally invasive surgery.

Compared with the current kyphoplasty, the present invention does not need hydraulic equipment, stretching appliances, and contrast agents, and the puncture tools involved in the special supporting auxiliary system can complete the positioning, puncture, and drilling of the pedicle at one time , Omit repeated puncture operations, greatly simplify the operation steps, reduce the number of X-ray transillumination, and improve the safety of the operation. Moreover, the application and processing of metals are more convenient than plastics, save production costs, and are beneficial to environmental protection and recycling.

The advantages of the present invention are:

1. Utilize the characteristics of memory alloys that are easy to shape at low temperature and reshape at body temperature, directly reset the vertebral body, change the pedicle screw technology to perform open reduction in the adjacent normal vertebral body, and break through the traditional spinal trauma vertebral body The viewpoint of two operations of posterior pedicle internal fixation and removal of internal fixation for compression fractures, one-time minimally invasive surgical treatment.

Description of drawings

The present invention will be further described below in conjunction with accompanying drawing and embodiment:

Fig. 1 is the basic structural representation of orthopedic resetter in the present invention;

Fig. 2 is the structural representation of puncture drill among the present invention;

Fig. 3 is the structural representation of pusher among the present invention;

Fig. 4 is the structural representation of working casing in the present invention;

Fig. 5 is the structural representation of injection tube and injection rod in the present invention;

Fig. 6 is a schematic structural view of a protective sleeve in the present invention;

Fig. 7 is a schematic diagram of different forms of orthopedic resetters in the present invention;

Fig. 8 is a schematic diagram of the operation process of the device for treating vertebral body compression fractures according to the present invention;

Among them: a is to complete the pedicle vertebral body puncture with skin and muscle protection sleeve and puncture drill

b: The orthopedic reducer after ice water shaping is implanted into the vertebral body through the pedicle working cannula

c is the reconstruction of the orthopedic reducer in the vertebral body

d for operation complete

Among them: 1. Head; 2. Body; 3. Tail; 4. Guide pin hole; 5. Open cone; 6. Equal-diameter self-tapping tap three-lobed groove drill; 8. Tail end; 10. Puncture guide pin ; 11, eccentric guide pin hole; 13, small ball; 14, guide pin hole; 15, groove; 16, working sleeve; 17, injection tube; 18, protective sleeve; 19, spherical shape; 20, Hemispherical; 21, football-shaped; 22, gourd-shaped; 23, injection rod; 24, rod; 25, handle.

Detailed ways

Embodiment: As shown in Fig. 1, Fig. 2, Fig. 3, Fig. 4, Fig. 5 and Fig. 6, a device for treating vertebral body compression fractures of the present invention consists of an implantable nickel-titanium temperature memory alloy orthopedic resetter and A special supporting auxiliary system is formed, wherein the supporting auxiliary system is composed of a puncture guide needle 10, a puncture drill, a pusher, a working sleeve 16, a protective sleeve 18, and an injection tube 17 and an injection rod 23.

According to different parts of the vertebral bodies and different compression geometries, the present invention designs the following parameters for selection:

First, as shown in Figure 1, the implantable nickel-titanium temperature memory alloy orthopedic reset device is composed of three parts: the head 1, the tail part 3 of the memory alloy wire convergence part and the body part 2 of the curved memory alloy wire; the orthopedic reset device The center of the head 1 has a guide needle hole 4 through which a puncture guide needle 10 can pass. The body 2 of the arc-shaped memory alloy wire is composed of 4-8 strands of memory alloy wire, further combined with that shown in Figure 7, the shape of the body 2 can be spherical 19 or hemispherical 20 or rugby ball 21 or gourd-shaped 22 to apply to different forms of vertebral compression fractures. The tail part 3 of the orthopedic resetter is a hollow connecting pipe, which can be matched with the top end of the special pusher.

The orthopedic resetter is made of 0.75mm and 1.0mm thick nickel-titanium temperature memory alloy plate, and its overall length design can have three specifications: 20mm, 25mm, and 30mm; wherein the length of the head 1 is set to 2mm; the length of the body 2 can be The length of the 3 connecting tubes at the tail is 4mm, and the wall thickness of the 3 connecting tubes at the tail is 0.3mm to 0.5mm.

According to the parameters of the pedicle, three specifications of the aperture of the tail 3 connecting tubes were designed, the outer diameter/inner diameter were 4.4mm/3.8mm, 5.0mm/4.2mm, 6.0mm/5.2m, respectively.

According to the height of the vertebral body in different parts, the height design of the corresponding orthopedic reducer after fully stretching is also designed into three specifications: 10mm, 13mm, and 16mm.

As shown in Figure 2, the top of the puncture drill in the supporting auxiliary system is a flat sharp opening cone 5; the drill body is an equal-diameter self-tapping tap three-lobed groove drill 6; the tail end 8 has a millimeter scale; Can pass through the eccentric guide pin channel 11 of the puncture guide pin 10; the total length of the puncture drill is 200mm, and the wide 3.5mm of the opening cone 5; the length of the drill body is 80mm, and the diameter is 5.5mm, 6.5mm, and 7.5mm. The piercing drill provides a passage for the working cannula 16 into the vertebral body.

As shown in Figure 3, the pusher is composed of a rod 24 and a handle 25. There is a small ball 13 and a groove 15 at the top of the rod 24, which are connected with the tail 3 of the orthopedic resetter; 10 guide pin holes 14 . The rod 24 of the pusher is 250mm long and 4mm in diameter; the handle 25 is 100mm long and 30mm in diameter.

As shown in FIG. 4 , the working sleeve 16 is a hollow tube, which can accommodate and shape a tubular orthopedic restorer under ice water. The length of the working sleeve 16 is designed to be 180mm; and corresponding to the three specifications of the aforementioned orthopedic resetter, the aperture specifications of the working sleeve 16 are designed as follows: outer diameter/inner diameter 5.2mm/4.6mm, 6mm/5.4mm, 7mm/6.4mm .

As shown in FIG. 5 , the injection tube 17 is a hollow tube through which the injection rod 23 can be used to inject bone cement or other biological glue materials into the orthopedic reducer. The injection tube 17 is 250mm in length and the outer diameter/inner diameter is 4.4mm/3.8mm; the injection rod 23 has a diameter of 3.5mm.

As shown in FIG. 6 , the protective sleeve 18 is a hollow tube that can accommodate the puncture drill and is used to protect the skin and muscles. The protective casing 18 is designed in two specifications, both of which are 120mm in length; and the outer diameter/inner diameter are 9mm/8mm and 7mm/6mm respectively.

With reference to the working process of the present invention shown in accompanying drawing 8, after the skin incision, the puncture drill is inserted into the protective sleeve 18 for protecting the skin muscle and reaches the vertebral rear, and the hammer nails the opening cone 5 into the vertebral bone. Under the supervision of a C-shaped X-ray machine, the puncture drill is drilled with bare hands until the opening cone reaches the back of the anterior cortex of the vertebral body, the puncture guide needle 10 is inserted, and the puncture drill is taken out; then the working sleeve 16 is placed into the pedicle.

The implantable nickel-titanium temperature memory alloy orthopedic resetter is treated with ice saline in vitro, and then shaped into a tubular shape. The tail part 3 is connected to the top of the rod 24 of the pusher, and the orthopedic resetter passes through the working sleeve along the puncture guide needle 10. The tube 16 enters the vertebral body, the puncture guide pin 10 is taken out, and the orthopedic reducer is left in the vertebral body.

Under the condition of body temperature, the orthopedic reducer is reshaped in the vertebral body to expand the fractured and collapsed affected vertebrae.

Then the pusher can be taken out, the injection tube 17 and the injection rod 23 can be inserted, and the bone cement or other biological glue materials can be poured into the orthopedic reducer. After the perfusion material is dry, take out the pedicle working sleeve 16 and the skin muscle protection sleeve 18, and the operation ends.

Claims (9)

1. A device for treating vertebral body compression fractures, characterized in that the device is composed of an implantable nickel-titanium temperature memory alloy orthopedic resetter and a special supporting auxiliary system, wherein the orthopedic resetter is composed of memory alloy wire converging parts The head (1), the tail (3) and the body (2) of the arc-shaped memory alloy wire are composed of three parts; the supporting auxiliary system is composed of a puncture guide needle (10), a graduated puncture needle with the above-mentioned puncture guide needle (10) Drill, pusher, working sleeve (16), protective sleeve (18), injection tube (17) and injection rod (23); the orthopedic resetter can be molded into a tubular shape under the state of ice water, through a fine The working sleeve (16) through the pedicle of the vertebral body can be reconstructed under the condition of body temperature after being implanted into the vertebral body. There are gaps between the memory alloy wires, which form a card slot; the orthopedic resetter can generate tension in the vertebral body, open and reset the fragmented, loose, and collapsed cancellous bone of the vertebral body, and restore the geometric shape of the vertebral body. 2. A device for treating vertebral body compression fractures according to claim 1, characterized in that the center of the head (1) of the orthopedic reducer has a guide needle hole through which the above-mentioned puncture guide needle (10) can pass Road (4). 3. A device for treating vertebral body compression fractures according to claim 1, characterized in that the body (2) of the arc-shaped memory alloy wire is composed of 4 to 8 strands of memory alloy wire, which is spherical (19) or hemispherical (20) or football-shaped (21) or gourd-shaped (22) to be applicable to vertebral body compression fractures of different forms. 4. A device for treating vertebral body compression fractures according to claim 1, characterized in that the tail (3) of the orthopedic reducer is a hollow connecting tube, which can be matched with the top end of a special pusher. 5. A device for treating vertebral body compression fractures according to claim 1, characterized in that the top end of the puncture drill in the supporting auxiliary system is a flat sharp opening cone (5); Tapping cone trilobe groove drill (6); the tail end (8) has a millimeter scale; there is an eccentric guide pin hole (11) that can pass through the above-mentioned puncture guide pin (10) in the puncture drill; the puncture drill can be used to enter the vertebral body The working casing (16) provides a passage. 6. A device for treating vertebral body compression fractures according to claim 1, characterized in that the working sleeve (16) in the supporting auxiliary system is a hollow tube, which can accommodate and pass ice water The lower shape is a tubular orthopedic reducer. 7. A device for treating vertebral body compression fractures according to claim 1, characterized in that the pusher in the supporting auxiliary system is composed of a rod (24) and a handle (25), and the rod (24) There is a small ball (13) and a groove (15) at the top, which are used to connect with the tail (3) of the orthopedic resetter; the pusher axis has a guide needle hole (14) through which the guide needle (10) can pass. 8. A device for treating vertebral body compression fractures according to claim 1, characterized in that the protective sleeve (18) in the supporting auxiliary system is a hollow tube that can be accommodated through the puncture drill. 9. A device for treating vertebral body compression fractures according to claim 1, characterized in that the injection tube (17) in the supporting auxiliary system is a device that can be reset to orthopedic through the injection rod (23). A hollow tube filled with bone cement.

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