CN117017460A

CN117017460A - Spinal column centrum screw rope and fixing orthopedic system thereof

Info

Publication number: CN117017460A
Application number: CN202311070007.6A
Authority: CN
Inventors: 赵群; 陈亮
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-08-24
Filing date: 2023-08-24
Publication date: 2023-11-10

Abstract

The invention discloses a spine vertebral screw rope, which is used for penetrating a spine vertebral screw and comprises a rope body extending from one end to the other end, and is characterized in that: the rope body is flexible. The invention is implanted minimally invasively under thoracoscope, abandons the concept of the traditional long-section broken nail rod fixation spine fusion, and the rope adopts high-elasticity PET to bind the lateral bending vertebral bodies, so that the lateral bending vertebral bodies are automatically reset and corrected in the growth process, the risk of spinal cord injury in operation is avoided, the spinal activity of a patient is also reserved, most of sports can be performed after the operation of the patient, and the life quality of the patient is greatly improved.

Description

Spinal column centrum screw rope and fixing orthopedic system thereof

Technical Field

The invention relates to the field of medical appliances, in particular to a spine centrum screw rope and a fixing orthopedic system thereof.

Background

According to statistics, the occurrence rate of scoliosis in China is 1.5% -3%, the current rate of scoliosis patients in China is more than 300 ten thousand, and the rate of scoliosis patients in China increases at 30 ten thousand per year, wherein more than half of scoliosis patients are teenagers, and teenagers aged 8-14 are the most common. Scoliosis has become the third biggest "killer" in China for children and teenagers to be harmed to health after obesity and myopia. Since 2019, country Wei Jianwei has seen spinal curvature abnormalities as a routine monitoring indicator in national student common disease and health-affecting factor monitoring.

For teenager scoliosis patients, the traditional spine orthopedic operation adopts a long-section fracture fixation and fusion operation mode, and the patients lose most of spinal activity. Patients require long hospitalization and bedridden treatment after surgery. Patients need to follow strict restrictions after operation, cannot engage in most sports, and the quality of life is obviously reduced.

With the deep research of teenager scoliosis, the novel minimally invasive technology is continuously advanced, and minimally invasive scoliosis anterior approach correction and loosening operation under a television thoracoscope are widely applied to clinic. The technique is mainly used as a novel minimally invasive operation for treating scoliosis, can be used for carrying out traditional long-section spine orthopedic fusion under the condition of minimally invasive, has good orthopedic effect, and is favored by patients and doctors.

At present, compared with the traditional incision spinal column orthopedic fusion, minimally invasive scoliosis anterior approach orthopedic and debonding operation under a television thoracoscope are considered to be reset, the trauma is smaller, the postoperative recovery is quick, and clinical application proves that the minimally invasive scoliosis anterior approach orthopedic and debonding operation is a safe and effective operation mode; minimally invasive scoliosis anterior approach orthopedics and debonding under a television thoracoscope are better choices for non-complex scoliosis patients, and can complete operations under a minimally invasive mode, reduce complications such as wound infection and the like.

In the prior art, no matter the traditional spine orthopedic fusion operation or the minimally invasive scoliosis anterior approach orthopedic and loosening operation under a television thoracoscope, the aim is to correct the malformed vertebral body in the operation immediately, correct cobb angle (the intersection angle of the perpendicular line of the upper edge of the vertebral head side end and the perpendicular line of the lower edge of the vertebral tail side end), which can cause spinal cord injury in the operation even paraplegia, and even doctors with abundant clinical experience cannot completely avoid spinal cord injury caused in the process of correcting the malformed vertebral body. Moreover, these two types of surgery emphasize vertebral body orthopedic spinal fusion, and the postoperative patient can lose most of vertebral body activity, severely reducing quality of life.

Disclosure of Invention

In order to solve the technical problems, the invention aims to provide a spine screw rope and a fixing orthopedic system thereof, wherein the spine screw rope can provide life quality after spine lateral curvature orthopedic operation of teenagers.

In order to achieve the above purpose, the technical scheme of the invention is as follows: a spine vertebral screw rope is used for penetrating a spine vertebral screw and comprises a rope body extending from one end to the other end, and the rope body is flexible.

According to the preferable technical scheme, the elastic modulus of the rope body material is 2.5-25 GPa.

According to a further technical scheme, the rope body can be made of polyethylene, polyester, and a composite material of polyethylene and polyester (such as polyethylene terephthalate (PET)).

In the above technical scheme, the rope body material can also be ultra-high-molecular-weight polyethylene (UHMWPE) and other novel composite materials meeting the requirements.

According to a further technical scheme, the rope body is formed by weaving a plurality of strands of fibers.

According to the preferable technical scheme, the rope body is provided with a marking part for assisting in positioning the vertebral body screw of the spine.

Further, the marking portion includes a first mark provided on the surface of the rope body.

Further, the marking portion includes a second mark visible under the medical image.

In the above technical scheme, the second mark may be a titanium alloy mark, and the pure rope is not developed on the X-ray, and the state of the rope cannot be directly observed with naked eyes in the operation. The titanium alloy mark is implanted in the rope, so that whether the rope is broken or not can be clearly seen in imaging, and the secondary timely operation intervention is not needed. The length change of the rope can be observed, so that the stress condition of the rope can be indirectly judged.

Further technical scheme, it still includes from the work portion of the outside extension of mark portion both ends and from the terminal portion of the outside extension of work portion, the diameter of terminal portion reduces gradually into the taper.

In the above technical solution, the rope except the working part can be forced to be toothed to form a certain pulling force because the rope can not be clamped to the working part during the operation, if the rope of the working part is clamped to the working part, the elastic modulus of the rope can be changed, and the rope can be broken in advance or the orthopedic effect is poor, so that the tail end part is arranged to be exclusively clamped.

According to the preferable technical scheme, the cross section of the rope body is circular, and the radius of the rope body is 4.5mm, 5.0mm, 5.5mm,6.0mm,6.5mm and the like.

According to the further technical scheme, the length of the rope body is 30cm, the length of the positioning portion is 10cm, each side of the length of the working portion is 5cm, and the length of the tail end portion is 5cm on each side.

The utility model provides a backbone centrum screw rope fixed orthopedic system, includes backbone centrum screw rope, a plurality of centrum screw, centrum screw is including implanting screw, lock nut, the draw-in groove has been seted up at implantation screw top, draw-in groove upper portion be provided with lock nut complex internal thread, backbone centrum screw rope place in the draw-in groove, lock nut locking backbone centrum screw rope.

The preferred technical scheme includes that the cone gasket includes circular piece, the through-hole has been seted up at circular piece center, fixed being provided with at least 3 implants foot on the circular piece, aim at for the structure increases stability, implant foot perpendicular to circular piece.

According to the preferable technical scheme, the diameter of the implanted screw is 5.5-7.0 mm, and the length of the implanted screw is 20-50 mm.

In a preferred embodiment, the screws may have a diameter of 5.5mm,6.0mm,6.5mm,7.0mm, a length of 20mm to 50mm, and an increment of 2.5mm, and are made of titanium alloy material and have a top loading design to facilitate rope insertion. The outer layer of the vertebral screw contains a hydroxyapatite coating.

According to the preferred technical scheme, the implantation screw is provided with a cavity in the length direction, and the diameter of the implantation screw is 1.75mm.

In the technical scheme, the screw with the cavity can be matched with the guide wire with the diameter of 1.45 mm. The screw was hollow with a hole of 1.75mm in diameter through which a 1.45mm k-wire could pass. When the nail is placed, under the condition that only one small skin incision is cut, a Kirschner wire with the thickness of 1.45mm is firstly inserted into the vertebral body, and if the angle and the direction of the nail are satisfied after perspective, a hollow screw can be directly inserted along the Kirschner wire until the vertebral body can be directly screwed in. Thus ensuring that the direction of the nail placement is completely consistent with the direction and the angle of the Kirschner wire. Can realize minimally invasive nail placement.

The invention has the advantages that:

1. the invention is implanted minimally invasively under thoracoscope, abandons the concept of the traditional long-section broken nail rod fixation spine fusion, and the rope adopts high-elasticity PET to bind the lateral bending vertebral bodies, so that the lateral bending vertebral bodies are automatically reset and corrected in the growth process, the risk of spinal cord injury in operation is avoided, the spinal activity of a patient is also reserved, most of sports can be performed after the operation of the patient, and the life quality of the patient is greatly improved.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are needed in the description of the embodiments will be briefly described below, in which the drawings are only some embodiments of the present invention, and other drawings can be obtained according to these drawings without inventive effort for a person skilled in the art.

The invention is further described below with reference to the accompanying drawings and examples:

FIG. 1 is a schematic illustration of the spinal column alignment configuration of the present invention;

FIG. 2 is a schematic illustration of a scoliosis configuration of the present invention;

FIG. 3 is a schematic representation of the spinal top view of the present invention;

fig. 4 is a schematic diagram of the rope construction of the present invention;

FIG. 5 is a schematic view of a rope marker of the present invention;

FIG. 6 is a pre-operative Cobb angle of infant in example 1;

FIG. 7 is the intraoperative Cobb angle of infant in example 1;

FIG. 8 is the postoperative Cobb angle of infant in example 1;

fig. 9 is a comparative graph of postoperative recovery of infant patients in example 1.

Wherein: 1. a rope; 2. a vertebral screw; 3. a lock nut; 4. a cone spacer; 5. a first mark; 6. a working section; 7. a distal end portion; 8. a second mark; 9. a marking part.

Detailed Description

Example 1:

as shown in fig. 1-5, a spine vertebral screw rope fixing orthopedic system comprises a rope 1 and a plurality of vertebral screws, wherein the vertebral screws 2 comprise implantation screws and locking nuts 3, clamping grooves are formed in the tops of the implantation screws, internal threads matched with the locking nuts 3 are formed in the upper parts of the clamping grooves, the spine vertebral screw rope 1 is placed in the clamping grooves, and the locking nuts 3 lock the spine vertebral screw rope 1.

The cone gasket 4 comprises a circular sheet, a through hole is formed in the center of the circular sheet, at least 3 implantation feet are fixedly arranged on the circular sheet, and the implantation feet are perpendicular to the circular sheet.

The implant screw is provided with a lengthwise cavity.

The spine vertebral screw rope 1 comprises a rope body extending from one end to the other end, wherein the rope body is flexible, is made of polyethylene terephthalate and is manufactured by adopting a braiding method. The rope body is provided with a marking part 9 for assisting in positioning the vertebral screw 2 of the spine. The marking 9 comprises a first marking 5 arranged on the surface of the rope and a second marking 8 visible under medical images. Further comprises a working part 6 extending outwards from two ends of the marking part 9 and a tail end part 7 extending outwards from the working part 6, wherein the diameter of the tail end part 7 is gradually reduced to be cone-shaped. The cross section of the rope body is circular, and the radius of the rope body is 4.5mm and 5.5mm.

Surgical indications of the invention:

the spine screw rope 1 and the fixing orthopedic system thereof are suitable for idiopathic scoliosis children irrelevant to nervous system diseases or other deformities or injuries, and correct scoliosis by guiding the growth of the spine, so that the spine screw rope is effective only for children and teenagers which do not reach mature height.

The bones are immature. Risser (degree of calcification during development of pelvic iliac spine) scores 0-3; sanders (Sander bone age, skeletal maturity of children assessed by X-ray examination of the left hand finger and wrist) scores 2-5.

To perform the surgery, the bone of the affected infant must be strong enough (not suffering from osteoporosis) to support the fixation of the screws 2. The spine activity is good, and the spine is checked by a plurality of imaging sheets which extend beyond the flexion position. No or only a slight amount of rotation of the spine occurs.

Although the condition varies from child to child and from teenager to teenager, most of the children who undergo this procedure are between 8 and 16 years of age.

Cobb (magnitude of lateral curvature angle, a method of measuring lateral curvature angle, used to evaluate the severity of scoliosis) is between 40 and 60 degrees.

Children with Cobb angles less than 40 degrees may be at risk of overcorrection during this process, and can be corrected in time by periodic review.

An infant with Cobb angle greater than 65 degrees may not achieve the same corrective effect as a healthy child.

Surgery is typically performed under thoracoscopy (minimally invasive). Approximately 10% of children need to undergo a re-surgery. There is little loss of spinal activity. The hospitalization time of the infant is usually two to three days after the operation. Most children return to school one to three weeks after surgery and resume normal and physical activities after six weeks.

The specific operation method of the embodiment comprises the following steps:

preoperative preparation: child patient: 10 years old, cobb angle 45 degrees, risser grade 0, row T6-T11 vertebral body constraint (VBT) procedure. The Cobb angle is 37 degrees after the operation, the Cobb angle is 21 degrees after the operation, and the Cobb angle is 19 degrees after the operation and 5 years. Imaging examination is needed before operation to confirm that the infant meets the operation index. The Cobb angle can be seen preoperatively, intraoperatively, and postoperatively in the infant as shown in fig. 6-8.

The operation steps are as follows:

anesthesia: prior to the beginning of the procedure, the patient may receive general anesthesia to ensure that the patient is not painful throughout the procedure. And then the patient is transferred to an operation table, the lateral position and the correct perspective positioning are performed, and then the operation incision and the nail placing inlet are determined, so that the correct visualization of each vertebral body and the clear display of the positive lateral position are ensured. The drape is then sterilized.

Surgical incision: the procedure typically selects a posterior axillary approach. Two to three thoracoscopic ports are inserted into the anterior axillary line, passed through the intercostal space of the side-curve deformed spine, and then connected to an ultrasonic blade and thoracoscope. Longitudinal cutting of parietal pleura using an ultrasonic knife and identification of the corresponding vertebral bodies, electrocoagulationPost-hemostasis exposure requires manipulation of the sides of the vertebral body. The opener, the open circuit device and the tap are used in sequence, and then the cone gasket and the screw are put in. The diameter and length of the screw areIs determined according to the vertebral body size of the infant before operation.

After all the required screws are nailed, the rope 1 is accurately introduced into the chest under the direct vision of the thoracoscope. Once the cable 1 is implanted in a vertebral body, the cable 1 is pulled tight using a tensioner to stress the lateral vertebral body, limiting the lateral spinal column growth. The rope 1 is implanted into all the vertebral screws 2 in sequence, and the tensioner is used for tightening and locking in sequence. The first and last sections of the deformed region are not tightened with a tensioner for tightening the ropes 1, and the middle section is sequentially tightened.

The applied tension will provide a preliminary correction to the curve being treated but more importantly it allows for growth regulation at the level. The amount of tension required will vary from person to person and will ultimately depend on a variety of factors including the pre-operative Cobb angle, curve flexibility, curve type, curve position, skeletal maturity, and desired growth, among others.

The forces applied at the different levels should be such that tightening and the resultant growth regulation will be able to achieve the desired corrective effect over time. But not too tight to prevent excessive orthopedics. The principle of tightening can be to use segmental tightening, i.e. tightening only one vertebral segment at a time. Multiple segments may also be used to simultaneously tighten, i.e., simultaneously tighten, more than one vertebral body segment. At least 3cm of cord 1 should be retained at the head and tail ends of the procedure so that later adjustments are required.

Suturing of the incision: when the cord 1 is properly implanted and tensioned, the incision is sutured. Typically, VBT (vertebral body constraint system) surgery requires only 2 to 4 small incisions, each of 1 to 2 cm in size. Suturing is typically very small and absorbent sutures can be used.

As shown in fig. 9, the recovery of spinal deformity was evident in the infant after the operation. And all sports can be completely recovered within 6 weeks after the operation of the child, so that the life quality is greatly improved.

Claims

1. A backbone centrum screw rope for wear to establish backbone centrum screw, its includes the rope body that extends to the other end from one end, its characterized in that: the rope body is flexible.

2. A spinal pedicle screw as recited in claim 1, wherein: the elastic modulus of the rope body material is 2.5-25 GPa.

3. A spinal pedicle screw as recited in claim 2, wherein: the rope body material can be polyethylene, polyester, and a composite material of polyethylene and polyester.

4. A spinal pedicle screw as recited in claim 2, wherein: the rope body is formed by weaving a plurality of strands of fibers.

5. A spinal pedicle screw as recited in claim 1, wherein: the rope body is provided with a marking part for assisting in positioning the spine vertebral screw, the marking part comprises a first marking arranged on the surface of the rope body, and the marking part comprises a second marking visible under medical images.

6. A spinal pedicle screw as recited in claim 5, wherein: the marking device further comprises a working part extending outwards from two ends of the marking part and a tail end part extending outwards from the working part, wherein the diameter of the tail end part is gradually reduced to be conical.

7. A spinal pedicle screw as recited in claim 1, wherein: the cross section of the rope body is circular, and the radius of the rope body is 4.5mm, 5.0mm, 5.5mm,6.0mm,6.5mm and the like; the length of the rope body is 30cm, the length of the positioning part is 10cm, the length of the working part is 5cm, and the length of the tail end part is 5cm.

8. A spinal column vertebral screw rope fixation orthopedic system, characterized by: a spinal column centrum screw rope, a plurality of centrum screws comprising the spinal column centrum screw rope of any one of claims 1-7, lock nut, implant screw top offered the draw-in groove, draw-in groove upper portion be provided with lock nut complex internal thread, spinal column centrum screw rope place in the draw-in groove, lock nut locking spinal column centrum screw rope.

9. A spinal pedicle screw cable fixation orthotic system as claimed in claim 8, wherein: the cone gasket comprises a circular sheet, a through hole is formed in the center of the circular sheet, at least 3 implantation feet are fixedly arranged on the circular sheet, and the implantation feet are perpendicular to the circular sheet.

10. A spinal pedicle screw cable fixation orthotic system as claimed in claim 8, wherein: the diameter of the implanted screw is 5.5-7.0 mm, and the length is 20-50 mm; the implant screw is provided with a cavity in the length direction.