CN111053606A - Integrated injection implementation method and device of injectable bone substitute in vertebroplasty - Google Patents
Integrated injection implementation method and device of injectable bone substitute in vertebroplasty Download PDFInfo
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- CN111053606A CN111053606A CN201911311859.3A CN201911311859A CN111053606A CN 111053606 A CN111053606 A CN 111053606A CN 201911311859 A CN201911311859 A CN 201911311859A CN 111053606 A CN111053606 A CN 111053606A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
- A61B17/8816—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
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Abstract
An integrated injection implementation method and device of injectable bone substitute in vertebral body molding, belonging to the field of medical apparatus. Inserting a memory alloy guide pin into the hollow tube for hot presetting, integrally and synchronously pushing the hollow tube and the memory alloy guide pin into the vertebral body, and quickly rebounding the hollow tube to the original curvature through internal stress under the guidance of the memory alloy guide pin to form a boundary of an injectable bone substitute filling space or serve as a boundary fence of the filling space; injecting an injectable bone substitute through the hollow tube to a designated location; at a designated location within the vertebral body, the injectable bone substitute fills the hollow tube and the enclosed filling space. The injection region of the injectable bone substitute has the planning property, and the multi-step operations of puncture, distraction, injection of endophyte and bone cement, molding and the like in the vertebroplasty are integrally realized; all the steps are carried out synchronously, so that the operation flow is greatly optimized, the operation time is shortened, and the operation difficulty is reduced. Can be widely applied to the field of design and manufacture of orthopedic implant injection devices.
Description
Technical Field
The present invention is in the field of surgical instruments, devices or methods, and more particularly, to a method and device for injecting and molding bone substitute into a vertebral body.
Background
Percutaneous Vertebroplasty (PVP) and Percutaneous Kyphoplasty (PKP) have been used clinically for many years, and the main clinical problems are:
1) uncertainty of bone cement injection area.
In the traditional balloon operation, injected bone cement has no boundary constraint, is freely dispersed and filled, and has poor controllability. Therefore, the injection amount is difficult to accurately calculate before the operation, the molding effect is difficult to achieve due to too little injection amount, and the side leakage risk is caused due to too much injection amount.
2) High probability of complications due to bone cement leakage.
When the outer cortical bone of the vertebral body is slightly damaged, the leakage effect cannot be avoided, once the vertebral body and the intervertebral foramen are leaked, nerve symptoms can be caused with high probability, and the leakage into the vein can form pulmonary embolism to endanger life;
3) the mechanical bearing effect is not good.
Because injected bone cement is dispersed without a fixed space structure, the maximum load bearing can not be formed in the vertical direction. The improper space distribution of the bone cement causes the bone cement to be unevenly stressed and easily broken, and then the vertebral body is secondarily collapsed, so that the repair operation has to be carried out.
4) The distraction of the vertebral body and the injection of bone cement in the traditional PKP need to be carried out step by step, the steps are complicated, most of operations such as distraction degree, injection amount of the bone cement, injection rate and the like need to be judged according to the experience of an operator, the fault tolerance rate is low, the repeatability is poor, and the requirement on the operation skill is extremely high.
How to plan and define the injection molding area of the bone cement before the operation, reduce or avoid the leakage of the bone cement, and combine the centrum expansion and the bone cement injection integrally, reduce the requirement or the dependence on the operation proficiency of an operator, so that the injected bone cement can have a better mechanical bearing effect, and the method is a technical problem which is tried to be solved in the actual work all the time.
Disclosure of Invention
The technical problem to be solved by the invention is to provide an integrated injection implementation method and device of injectable bone substitute in vertebral body molding, wherein a linear memory alloy guide pin is inserted into a biocompatible polymer hollow tube for hot pre-molding, the biocompatible polymer hollow tube and the memory alloy guide pin are integrally and synchronously pushed into a vertebral body, and the biocompatible polymer hollow tube is quickly rebounded to the original curvature through internal stress under the guidance of the memory alloy guide pin, thereby forming the boundary of an injectable bone substitute filling space or serving as a boundary fence of the filling space; then injecting the injectable bone substitute through the hollow tube to a designated location; and then at the appointed position in the vertebral body, the injectable bone substitute is filled in the biocompatible polymer hollow tube and the filling space surrounded by the biocompatible polymer hollow tube. The injection region of the injectable bone substitute has the planning property, and the multi-step operations of puncture, distraction, injection of endophyte and bone cement, molding and the like in the vertebroplasty are integrally realized; all the steps are carried out synchronously, so that the operation flow is greatly optimized, the operation time is shortened, and the operation difficulty is reduced.
The technical scheme of the invention is as follows: provides an integrated injection implementation method of an injectable bone substitute in vertebral body molding, which is characterized in that:
1) pre-bending a biocompatible polymer hollow tube, and sealing the front end of the biocompatible polymer hollow tube;
2) a linear memory alloy guide needle is inserted into the biocompatible polymer hollow tube, and the memory alloy guide needle forms a needle core of the biocompatible polymer hollow tube, so that the memory alloy guide needle and the biocompatible polymer hollow tube form an integrated structure;
3) performing thermal presetting on the biocompatible polymer hollow tube inserted with the needle core to form a required preset structural shape;
4) a pushing driving device at least comprising a section of straight tube segment-shaped structure of a puncture sleeve is adopted to force a biocompatible polymer hollow tube with a preset structural shape and a memory alloy guide needle to be synchronously pushed into a vertebral body in a linear structural form;
5) at the appointed position in the centrum, the biocompatible polymer hollow tube separated from the straight tube segment puncture sleeve is quickly rebounded to the original curvature through the internal stress under the guidance of the memory alloy guide pin and keeps consistent with the preset structural shape;
6) continuously and synchronously pushing the biocompatible polymer hollow tube and the memory alloy guide needle;
7) under the guide of the memory alloy guide pin, the biocompatible polymer hollow tube continues to form a preset structural shape at the designated position in the vertebral body until the shape or height completely meets the requirement, and the vertebral body is expanded to the required interval;
8) drawing out the memory alloy needle in the biocompatible polymer hollow tube;
9) injecting the injectable bone substitute into a biocompatible polymer hollow tube;
10) the injectable bone substitute is continuously injected to a designated position in the vertebral body through the guidance and the limitation of the biocompatible polymer hollow tube;
11) at the designated position in the vertebral body, the biocompatible polymer hollow tube is filled with the injectable bone substitute, or the biocompatible polymer hollow tube and the filling space surrounded by the biocompatible polymer hollow tube are filled with the injectable bone substitute;
12) cutting off the biocompatible polymer hollow tube which exceeds the outside of the vertebral body or has the required length;
13) the injectable bone substitute forms a three-dimensional filling body at the designated position in the vertebral body;
14) after the injectable bone substitute filled in a three-dimensional shape is solidified, a bone substitute which can bear pressure and has the same or similar strength with the vertebral body at the position is formed;
the integrated injection implementation method is characterized in that a biocompatible polymer hollow tube using a memory alloy guide needle as a 'needle core' is pushed/injected to a designated position in a vertebral body to form a boundary of a filling space or serve as a boundary fence of the filling space, so that the forming plannability and controllability of the injectable bone substitute are realized, the leakage risk of the injectable bone substitute is eliminated, and the multi-step operations of puncture, distraction, injection of plants in the vertebral body forming operation, forming and curing of the injectable bone substitute are integrally realized; thereby optimizing the operation flow, shortening the operation time and reducing the operation difficulty.
In particular, the injectable bone substitute comprises at least injectable bone cement, CPC or gel.
The injectable bone substitute has the advantages of programmable and controllable molding, at least comprises an injection area of the injectable bone substitute, controllable implantation position of the injectable bone substitute, controllable injection quantity of the injectable bone substitute, controllable expansion/molding effect of the injectable bone substitute and controllable mechanical support of the injectable bone substitute.
The predetermined structural shape includes at least a helical coil structure.
Further, the pre-bending treatment of the biocompatible polymer hollow tube comprises processing/arranging a ring-shaped, snake-shaped or spiral cutting groove on the outer surface of the biocompatible polymer hollow tube to facilitate the heat pre-shaping and the recovery of the pre-shaped structure of the biocompatible polymer hollow tube.
The technical scheme of the invention also provides an integrated injection device for injecting the bone substitute in the vertebral body molding, which is characterized in that:
the integrated injection device at least comprises a pushing driving device, a biocompatible polymer hollow tube and a linear memory alloy guide needle;
the pushing driving device is provided with a section of straight tubular puncture sleeve;
the memory alloy guide needle penetrates through the biocompatible polymer hollow tube;
the front end of the biocompatible polymer hollow tube is closed;
the pushing driving device is used for pushing the biocompatible polymer hollow tube and the memory alloy guide pin to a designated position in the vertebral body;
the memory alloy guide needle is used for guiding the biocompatible polymer hollow tube to be bent and molded, discharging most of air in the hollow tube, preventing the biocompatible polymer hollow tube from extruding an injection channel when being bent, and keeping a good injectable bone substitute injection channel;
the biocompatible polymer hollow tube forms an injection channel of the injectable bone substitute and a boundary or a boundary fence of the injectable bone substitute filling space.
Furthermore, the biocompatible polymer hollow tube and the memory alloy guide needle which are subjected to hot pre-setting are pre-formed and then are placed into a pushing driving device; inserting a puncture sleeve of a pushing driving device to a required designated position in the vertebral body; the pushing driving device continuously and synchronously integrally sends out the prefabricated biocompatible polymer hollow tube and the memory alloy guide needle by means of the puncture sleeve; under the forced restraint and guidance of the straight tubular puncture sleeve, the preformed biocompatible polymer hollow tube and the memory alloy guide needle are sent to the designated position in the vertebral body in a straight tube/straight line shape; the biocompatible polymer hollow tube leaving the straight tubular puncture sleeve is quickly rebounded to the original curvature through the internal stress under the guidance of the memory alloy guide needle, and is consistent with the shape recovery/keeping after thermal presetting.
The integrated injection device continuously and integrally pushes the biocompatible polymer hollow tube and the memory alloy guide needle, so that an injectable bone substitute filling space which is the same as or similar to the shape of the biocompatible polymer hollow tube after hot pre-setting is formed in the vertebral body.
Furthermore, a plurality of side holes are arranged on one side of the biocompatible polymer hollow tube; when the biocompatible polymer hollow tube is pre-shaped by heat, the side hole faces to the inside of a filling space surrounded by the biocompatible polymer hollow tube; by pushing/injecting, the injectable bone substitute fills the inner space of the biocompatible polymer hollow tube; or, the injectable bone substitute is pushed/injected to pass through the biocompatible polymer hollow tube with a plurality of side hole structures, so as to fill the biocompatible polymer hollow tube and the three-dimensional filling space surrounded by the biocompatible polymer hollow tube.
The technical scheme of the invention also provides an integrated injection device for injecting the bone substitute in the vertebral body molding, which is characterized in that:
the integrated injection device comprises a pushing driving device, a flexible hose shaft tube, a head drill bit and a linear memory alloy guide pin; the head drill bit is arranged at the head end of the flexible hose shaft tube; the tail end of the flexible hose shaft tube is connected with the pushing driving device; the linear memory alloy guide pin penetrates through the flexible hose shaft tube; the pushing driving device is provided with a section of straight tubular puncture sleeve; the memory alloy guide pin is used for guiding the flexible shaft tube to be bent and formed.
The propelling driving device drives the head drill bit to rotate through the flexible hose shaft tube, and the flexible hose shaft tube, the head drill bit and the memory alloy guide pin are propelled to the designated position in the vertebral body along the path guided by the memory alloy guide pin; meanwhile, the pushing driving device continuously and synchronously integrally sends out the flexible soft shaft tube, the memory alloy guide pin and the head drill bit by means of the puncture sleeve.
The flexible shaft tube forms an injection channel of the injectable bone substitute and a boundary or a boundary fence of the injectable bone substitute filling space.
The integrated injection device continuously tunnels a spiral bone tunnel for accommodating the flexible soft shaft tube in a vertebral body through a shield tunneling mode.
Specifically, a memory alloy guide pin is inserted into a flexible hose shaft tube, and is placed into a push driving device after being subjected to hot pre-setting; inserting a puncture sleeve of a pushing driving device to a required designated position in the vertebral body; the pushing driving device continuously and synchronously integrally sends out the flexible hose shaft tube and the memory alloy guide pin after hot pre-setting by means of the puncture sleeve.
Under the forced restraint and guidance of the straight tubular puncture sleeve, the flexible hose shaft tube and the memory alloy guide needle after hot pre-setting are sent to the designated position in the vertebral body in a straight tube/straight line shape; the pushing driving device drives the head drill bit to rotate through the flexible hose shaft tube to form a shield tunneling mode; the flexible hose shaft tube leaving the straight tubular puncture sleeve is quickly rebounded to the original curvature through the internal stress under the guidance of the memory alloy guide pin, and is consistent with the shape recovery/keeping after thermal presetting.
The head drill bit is guided by the memory alloy guide pin to form a spiral bone tunnel in the vertebral body; the flexible hose shaft tube forms an injectable bone substitute filling space with the same or similar shape to the memory alloy guide pin after hot presetting in the vertebral body along the spiral bone tunnel under the guidance of the memory alloy guide pin.
Furthermore, the flexible shaft pipe comprises a four-layer structure, and the outer layer of the flexible shaft pipe is a degradable polymer pipe; after the tunneling of the bone tunnel is completed, the bone tunnel is kept in the vertebral body, and then injectable bone substitute is injected into the vertebral body; the middle layer is a wear-resistant pipe, and the outer diameter of the wear-resistant pipe is equal to the inner diameter of the outer layer pipe; after the tunneling of the bone tunnel is finished, the wear-resistant pipe, the inner layer driving shaft, the memory alloy guide pin and the puncture sleeve are pulled out together; the inner layer of the wear-resistant tube is a flexible rotating shaft for driving the drill bit to rotate, the diameter of the flexible rotating shaft is half of that of the wear-resistant tube, and a hollow pipeline is formed between the flexible rotating shaft and the wear-resistant tube and used for discharging bone fragments; after the tunneling of the bone tunnel is finished, the flexible rotating shaft, the inner layer driving shaft, the memory alloy guide pin and the puncture sleeve are pulled out together; the flexible rotating shaft is internally provided with a hollow shaft core layer, the shaft core layer is of a hollow structure in the flexible driving shaft, and the diameter of the shaft core layer can be used for the memory alloy guide needle to freely pass through.
Wherein the space between the outer layer and the middle layer forms an annular tubular structure for providing an evacuation channel for bone debris drilled by the drill bit.
Furthermore, the shape of the memory alloy guide pin after the hot presetting at least comprises a spiral shape structure; the outer surface of the biocompatible polymer hollow tube or the flexible hose shaft tube is provided with a ring-shaped, snake-shaped or spiral groove.
Compared with the prior art, the invention has the advantages that:
1. a determined injectable bone substitute filling space is formed inside the vertebral body through an injectable instrument/endophyte (namely the biocompatible polymer hollow tube or the flexible hose shaft tube), so that an injectable bone substitute injection area has plannability, and the injection amount of bone cement can be calculated through a pre-operation established space structure;
2. the mechanical effect of the injectable bone substitute can be accurately obtained through the spatial structure and the dosage of the injectable bone substitute, and the consistency of the internal and external mechanical properties of the implanted object is ensured;
3. the fence structure formed by the injectable apparatus/endophyte avoids and eliminates the leakage risk of the injectable bone substitute, and avoids various complications caused by the leakage risk;
4. the puncture, the tunneling and the molding of the bone tunnel and the injection of the injectable bone substitute can be completed at one time, thereby simplifying the operation steps and improving the vertebroplasty from the empirical operation to the digital, mechanical and standard quantifiable level.
Drawings
FIG. 1 is a schematic flow diagram of the process of the present invention;
FIG. 2 is a schematic structural diagram of a hollow tube made of biocompatible polymer according to the present invention;
FIG. 3 is a schematic view of the structure of a hollow tube of biocompatible polymer with a groove on the outer periphery;
FIG. 4 is a schematic structural diagram of a spiral biocompatible polymer hollow tube;
FIG. 5 is a schematic structural view of a spiral biocompatible polymer hollow tube with grooves;
FIG. 6 is a schematic structural diagram of the pushing driving device;
FIG. 7 is a schematic diagram of the operation of the push actuator;
FIG. 8 is a schematic view of the present invention showing the simultaneous puncture of a hollow biocompatible polymer tube and a guiding needle made of memory alloy;
FIG. 9 is a schematic view of the memory alloy needle beginning to bend into a spiral shape;
fig. 10 is a schematic view of the biocompatible polymer hollow tube after the entire bending process is completed;
FIG. 11 is a schematic view of the structural shape of the memory alloy needle in the fill space;
FIG. 12 is a schematic drawing of the withdrawn memory alloy needle;
FIG. 13 is a schematic view of beginning injection of bone cement;
FIG. 14 is a schematic view showing that the bone cement is not overflowed from the side hole after the biocompatible polymer hollow tube is completely filled with the bone cement;
FIG. 15 is a schematic view of the bone cement fully filling the biocompatible polymer hollow tube and overflowing the side hole;
FIG. 16 is a schematic structural view of a shield bit and its flexible shaft;
FIG. 17 is a schematic view of the construction of the flexible hose shaft tube;
FIG. 18 is a cross-sectional structural schematic view of the flexible hose shaft tube;
FIG. 19 is an enlarged partial view of portion A of FIG. 18;
FIG. 20 is a schematic view of the penetration of a hollow tube of biocompatible polymer to the injection site;
FIG. 21 is a schematic view of the drill reaching the origin of the pedicle;
FIG. 22 is a schematic view of a guidewire-guided flexible drill bit simultaneously tunneling a bone tunnel;
figure 23 is a schematic representation of the completion of the tunneling of the bone tunnel;
fig. 24 is a schematic view of the bone cement filled.
In the figure, 0 is the centrum, 1 is the biocompatible polymer hollow tube, 1A is the spiral pipe, 2 is the blind end, 3 is the inside hole, 4 is the cutting groove, 5 is the memory alloy guide pin, 6 is the puncture sleeve, 6A is the pjncture needle, 7 is the propelling movement drive arrangement, 8 is injectable bone substitute, 9 is the bone substitute, 10 is the drive handle, 11 is the drive shaft, 12 is the belt, 13A is the initiative roller bearing, 13B is the passive roller bearing, 14 is the injectable spiral pipe storehouse, 20 is the head drill bit, 21 is the degradable pipe, 22 is wear-resisting pipe, 23 is flexible pivot, 24 is the hollow axle core layer, 25 is the ring pipe.
Detailed Description
The invention is further illustrated with reference to the following figures and examples.
In fig. 1, the technical solution of the present invention provides an integrated injection implementation method of injectable bone substitute in vertebroplasty, which is characterized in that:
pre-bending a biocompatible polymer hollow tube (hollow tube or pipe for short) 1, and sealing the front end to form a closed end 2;
a linear memory alloy guide needle 5 is inserted into a biocompatible polymer hollow tube, and the memory alloy guide needle forms a 'needle core' of the hollow tube, so that the two form an integrated structure;
performing thermal presetting on the biocompatible polymer hollow tube inserted with the needle core to form a required preset structural shape;
a pushing driving device at least comprising a section of straight tube segment-shaped structure of a puncture sleeve 6 is adopted to force a biocompatible polymer hollow tube with a preset structural shape and a memory alloy guide needle to enter a vertebral body synchronously in a linear structural form under the action of the puncture sleeve;
at the appointed position in the centrum, the biocompatible polymer hollow tube separated from the straight tube segment puncture sleeve is quickly rebounded to the original curvature through the internal stress under the guidance of the memory alloy guide pin and keeps consistent with the preset structural shape;
continuously and synchronously pushing the biocompatible polymer hollow tube and the memory alloy guide needle;
under the guide of the memory alloy guide pin, the biocompatible polymer hollow tube is continuously bent at the designated position in the vertebral body to form a preset structural shape until the shape or height completely meets the requirement, and the vertebral body is expanded to the required interval;
drawing out the memory alloy needle in the biocompatible polymer hollow tube;
injecting the injectable bone substitute 8 into a biocompatible polymeric hollow tube;
the injectable bone substitute is continuously injected to a designated position in the vertebral body through the guidance and the limitation of the biocompatible polymer hollow tube;
at the designated position in the vertebral body, the biocompatible polymer hollow tube is filled with the injectable bone substitute, or the biocompatible polymer hollow tube and the filling space surrounded by the biocompatible polymer hollow tube are filled with the injectable bone substitute;
the injectable bone substitute forms a three-dimensional filling body at the designated position in the vertebral body;
after the injectable bone substitute filled in a three-dimensional shape is solidified, a bone substitute which can bear pressure and has the same or similar strength with the vertebral body at the position is formed;
the integrated injection implementation method is characterized in that a biocompatible polymer hollow tube using a memory alloy guide needle as a 'needle core' is pushed/injected to a designated position in a vertebral body to form a boundary of a filling space or serve as a boundary fence of the filling space, so that the forming plannability and controllability of the injectable bone substitute are realized, the leakage risk of the injectable bone substitute is eliminated, and the multi-step operations of puncture, distraction, injection of plants in the vertebral body forming operation, forming and curing of the injectable bone substitute are integrally realized; thereby optimizing the operation flow, shortening the operation time and reducing the operation difficulty.
The technical scheme of the invention belongs to orthopedic implants and corresponding matched tools, and more particularly relates to a method and a device for forming injectable bone substitutes (also called injectable bone cement, for short), which do not belong to methods for diagnosing and treating diseases.
The material of the biocompatible polymer hollow tube in the technical scheme of the invention can be one of PEEK (poly-ether-ether-ketone resin), PLGA (poly-co-glycolic acid, glycolic acid-lactic acid copolymer), PCL (Polycaprolactone), PGA (Polyglycolic acid, or PLA (polylactic acid).
The injection region at least comprising the injectable bone substitute has the advantages of programmability, controllable injection position of the injectable bone substitute, controllable injection quantity of the injectable bone substitute, controllable distraction/molding effect of the injectable bone substitute and controllable mechanical support of the injectable bone substitute.
The preset structural shape in the technical scheme of the invention at least comprises a spiral coil structure.
In addition, although the technical solution of the patent is described as injectable bone substitute, it is applicable to the method, including but not limited to injectable bone Cement, CPC (Calcium Phosphate Cement), gel, etc.; the technical scheme is not only suitable for common bone substitutes at the present stage, but also suitable for injectable bone materials with better performance in the future along with the improvement of materials science.
Although the technical scheme of the patent is described by the spiral forming area, the method can realize various injection forming structures except spiral, and can construct any space shape according to clinical needs.
Obviously, the technical scheme of the patent integrates multiple operations of puncture, distraction, injection of plant and bone cement in vertebroplasty, molding and the like; and a plurality of steps are carried out synchronously, so that the operation process is greatly optimized, the operation time is shortened, and the operation difficulty is reduced.
Example (b):
example 1:
1. preparation of materials:
a) selecting a PEEK thin-walled tube as a biocompatible polymer hollow tube:
the tubing had an outer diameter of about 4mm and a thickness of about 1.5 mm.
b) Pre-bending treatment of the PEEK pipe:
i. the starting or leading end of the hollow tube 1 of biocompatible polymer (i.e. the end which is first injected into the vertebral body 0) is closed, and a closed end 2 is formed at the leading end (as shown in fig. 2).
And ii, punching the inner side of the pipe to form an inner side hole 3, wherein the hole diameter of the inner side hole is matched with the bone cement flow and is about 2 mm. Because the starting end is closed, the bone cement can be injected into the inner space of the spiral pipe through the inner hole after being injected into the pipe.
Making a circular or serpentine cut in the surface of the tubing, forming a circular, serpentine or helical cut 4 in the outer surface of the tubing (see fig. 3).
The cutting mode and the cutting depth need to ensure that the tube wall is not damaged, and the bone cement cannot leak.
c) Inserting a memory alloy guide pin 5 into the hollow tube:
the memory alloy guide needle has two purposes, namely, when the memory alloy guide needle is bent in a vertebral body, the memory alloy is bent into a spiral shape to guide the molding of a biocompatible polymer hollow tube; secondly, most of air in the hollow tube is discharged, so that the formation of thrombus is reduced; and thirdly, a good bone cement injection channel is kept, and the biocompatible polymer hollow tube is prevented from extruding the injection channel when being bent.
d.) carrying out thermal pre-shaping on the biocompatible polymer hollow tube inserted with the needle core:
i. pre-bending the biocompatible polymer hollow tube into a spiral structure (see fig. 4 and 5, which are referred to as spiral tubes for short) by a heat setting method on the premise of reducing the surface tension of the biocompatible polymer hollow tube by annular/snake-shaped cutting and inner side holes; the outer diameter of the spiral pipe 1A is adjustable, and the spiral pipe can be prefabricated into different specifications according to requirements;
and ii, the hot-formed spiral pipe is of a disc-shaped structure, and the hot-formed spiral pipe needs to be located in a material elastic area to ensure that the spiral pipe can be completely rebounded after being straightened.
The actual operation implementation process comprises the following steps:
a) injection of PEEK screw into vertebral bodies:
i. the "full disk" of coils 1A is loaded into the injectable coil magazine 14 of the injection gun (i.e., the pusher drive 7 as previously described) and the closed start end is loaded into the bore of the gun (see fig. 6, 7).
The bore of the injection gun is connected to the piercing sleeve 6. The inner diameter of the puncture sleeve is matched with the tolerance of the outer diameter of the spiral tube (namely the biocompatible polymer hollow tube); then the memory alloy guide needle is inserted into the biocompatible polymer hollow tube from the muzzle to form the biocompatible polymer hollow tube with the needle core.
And iii, the spiral biocompatible polymer hollow tube and the memory alloy guide needle can be synchronously and integrally injected (or pushed into) the vertebral body slowly by the driving of the injection gun.
The PEEK tube which is subjected to thermal pre-setting is forced to be straightened only temporarily when passing through a puncture sleeve of an injection needle due to the fact that the PEEK tube is located in an elastic area of the material; after the PEEK tube which is pre-shaped penetrates out of the puncture sleeve of the injection needle once, the PEEK tube is quickly rebounded to the original curvature through internal stress under the guidance of the memory alloy guide needle, and the shape (namely the spiral tube shape) which is pre-shaped is kept consistent with the original curvature.
b) Injection of bone cement:
after the injection of PEEK spiral tube (also called injectable spiral tube) is finished, the injection gun is changed into a 'magazine' for loading the injected material, and the mixed injectable bone cement is loaded.
injecting a certain amount of bone cement (which can be estimated in advance according to the size and dimension of the preformed spiral tube) into the PEEK tube by operating or controlling the injection gun within the curing allowable time of the injectable bone cement.
And iii, measuring and calculating the dosage of the bone cement carefully, and including the volume in the hollow tube and the hollow area in the space surrounded by the spiral tube. Ensuring that the bone cement fills all the predetermined areas.
c) Gun configuration (see fig. 6, 7):
i. the driving handle 10 is pressed to drive the driving shaft 11, which transmits power to the two driving rollers 13A at the lower part through the belt 12 (belt connection).
The upper two rollers 13B are passive rollers and do not directly provide power.
And iii, the distance between the upper roller and the lower roller is adjustable and is consistent with the outer diameter of the spiral pipe. The detachable spiral tube is temporarily straightened and then extruded into the puncture sleeve.
The injectable spiral tube bin 14 is of a detachable structure and can be filled with spiral tubes of different specifications according to requirements. The "clip" structure of firearms is not described in detail herein.
It should be noted that the pushing driving device in the technical solution of the present invention is not limited to the pistol type structure shown in fig. 6 and fig. 7; those skilled in the art, having the understanding and appreciation of the present invention for solving the problems, will be able to fully utilize other similar devices having pushing and injecting functions for pushing the PEEK spiral tube and injecting the bone cement, and will not be described in detail herein.
The injection/advancement step is illustrated schematically and is shown in fig. 8-15.
Step 1: the biocompatible polymer hollow tube 1 and the memory alloy guide needle 5 are injected/pushed synchronously;
fig. 8 shows that the hollow tube 1 after being injected/pushed out of the puncture sleeve forms a helical (coiled) structure in the vertebral body 0 under the guidance and action of the memory alloy guiding needle 5.
The shape of the memory alloy introducer needle 5 in the hollow tube and its guiding effect on the formation of the hollow tube of biocompatible polymer are highlighted in fig. 9.
Step 2: under the guide of the memory alloy needle, the injection/propulsion of the biocompatible polymer hollow tube is completed;
the hollow tube in which the coil 1A has been formed within the vertebral body 0 is highlighted in fig. 10.
In fig. 11, the shape of the memory alloy guiding needle and the guiding function for the formation of the hollow tube of biocompatible polymer are highlighted, and the hollow tube of biocompatible polymer itself is desalted to highlight the shape of the memory alloy guiding needle.
And step 3: drawing out the memory alloy needle in the biocompatible polymer hollow tube;
in fig. 12 it is emphasized that the memory alloy needle 5 is withdrawn from the hollow tube 1 of biocompatible polymer in the direction of the arrow in the figure, so that only a hollow spiral tube 1A remains in the vertebral body 0 and has formed a helical structure in the vertebral body, the spiral tube constituting the boundary of the filling space of the injectable bone substitute or acting as a boundary enclosure for the filling space.
And 4, step 4: injecting the bone cement into the biocompatible polymer hollow tube.
In fig. 13, the emphasis is on showing a spiral tube 1A leaving a hollow in the vertebral body and having formed a helical structure within the vertebral body, and an injectable bone substitute 8 injected through the hollow tube 1 of biocompatible polymer.
At this time, the injectable bone substitute is only filled into the tube space of a part of the spiral tube, and the tube space of the other spiral tube is not filled.
In fig. 14, the injectable bone substitute 8 is highlighted as having completely filled the helical hollow tube, not yet overflowing from the inner hole of the hollow tube.
In fig. 15, the condition is highlighted in which the injectable bone substitute 8 has completely filled the space inside the tube of the hollow tube 1, and has overflowed from the inner hole.
At the moment, the injectable bone substitute forms a three-dimensional filling body at the designated position in the vertebral body, and after the injectable bone substitute is solidified, a bone substitute 9 which can bear pressure and has the same or similar strength with the vertebral body at the position can be formed.
Obviously, the aforementioned helical hollow tube constitutes both the injection channel of the injectable bone substitute and the boundary or boundary fence of the injectable bone substitute filling space.
In the above figures, when the biocompatible polymer hollow tube is denoted by 1, it is emphasized that it has a hollow tubular structure, and when the spiral biocompatible polymer hollow tube is denoted by 1A, it is emphasized that it has a spiral coil structure, and in order to emphasize the hollow characteristic of the spiral tube, there is also a case where the spiral tube portion is denoted by 1.
After the operation of the steps, the technical scheme of the invention adopts an integrated injection implementation method, and the forming programmability and controllability of the injectable bone substitute are realized by pushing/injecting the biocompatible polymer hollow tube which is used as a needle core by the memory alloy guide needle to a designated position in a vertebral body to form a boundary of an injectable bone substitute filling space or a boundary fence used as the filling space, so as to avoid the leakage risk of the injectable bone substitute, and further realize the multi-step operations of puncture, distraction, injection of the bone substitute, forming and curing of the injectable bone substitute in the vertebroplasty integrally; thereby optimizing the operation flow, shortening the operation time and reducing the operation difficulty.
Example 2:
basic ideas for solving the problems are as follows:
continuously tunneling a spiral tunnel in a vertebral body by combining the basic principles of a tunnel shield machine/a tunneling machine and a flexible shaft drill; then withdraw from the flexible central siphon with the drill bit, detain the degradable part of flexible central siphon in the tunnel simultaneously, inject bone cement into the degradable flexible central siphon at last, accomplish the bone cement shield of spiral tunnel.
Specifically, the implementation process is as follows:
1) flexible shield system under memory alloy guide pin (also called seal wire) guide:
a. the system consists of a nose drill 20 (shown in fig. 16), a middle flexible hose tube, and a tail drive (not shown).
b. Wherein, the flexible shaft part is divided into four layers: the outer layer is a degradable tube 21, the middle layer is a wear-resistant tube 22, the inner layer is a flexible spindle 23 that drives the drill bit to rotate, and a hollow core layer 24 inside the spindle (see fig. 17-18).
c. The space between the outer and middle layers of the flexible hose tube may form an annular tube 25 that provides an output passage for bone chips drilled by the drill bit (see fig. 18, 19).
d. The guide wire (i.e., the aforementioned memory alloy guide pin 5) is used to guide the drill bit to follow a predetermined path, such as spiral ascending or descending, or any other arbitrary path.
2) The shield construction process:
a. the flexible shield system comprises:
i. the drill bit 20 is integrally connected with the flexible rotating shaft 23, is exposed out of the degradable tube 21 and is used for drilling and tunneling in vertebral sclerotin. The flexible hose shaft tube is formed by wrapping the four layers of tubular structures layer by layer.
Outer tube: in order to degrade the polymer tube, after the tunneling of the bone tunnel is completed, the bone tunnel is kept in the vertebral body, and then bone cement is injected into the vertebral body.
intermediate pipe: the outer diameter of the wear-resistant pipe is equal to the inner diameter of the outer layer pipe, and the wear-resistant pipe is tightly attached to the outer layer pipe. The abrasion of the rotating shaft to the outer degradable pipe in the drilling process is prevented. After the tunneling of the bone tunnel is finished, the bone tunnel is pulled out together with the inner layer driving shaft, the guide wire and the puncture needle.
inner tube: the flexible shaft 23, which is used to drive the drill bit in rotation, has a diameter of about half that of the middle tube, and a hollow annular channel 25 is formed between the two for the evacuation of bone debris. After the tunneling of the bone tunnel is finished, the bone tunnel is pulled out together with the flexible rotating shaft for inner layer driving, the guide wire and the puncture sleeve.
v. axial layer: is a hollow structure in the flexible driving shaft, and the size of the hollow structure can be freely passed by a puncture needle or a guide wire.
b. With the aid of X-rays, the puncture sleeve 6 and the puncture needle 6A therein are pushed percutaneously to the injection starting point (see fig. 20) using the method in example 1.
c. After the puncture needle is withdrawn from the puncture sleeve, the guide wire is threaded, and the flexible shield system is threaded through the hollow tube of its axial layer, into the puncture sleeve, and to the injection start of the pedicle (see fig. 21).
Starting a driving motor (not shown in the figure) of the flexible rotating shaft, and synchronously performing bone tunneling (see figure 22) by the flexible hose shaft pipe under the guidance of the guide wire 5; the bone debris from the shield is discharged through the annular conduit between the inner and middle layers.
The situation after the tunneling of the bone is completed is shown in fig. 23.
d. After tunneling is finished, the outer layer (degradable tube) of the flexible soft shaft tube is kept in the vertebral body, and meanwhile the guide wire, the drill bit, the rotating shaft connected with the drill bit and the middle-layer wear-resistant tube in the flexible soft shaft tube are sequentially pulled out.
e. After the driving device (motor) at the tail part of the hose shaft tube is unloaded, an injectable bone substitute injection gun is installed at the tail part of the outer degradable tube; the injectable bone substitute includes, but is not limited to, bone cement, PMMA (polymethylmethacrylate).
f. The injectable bone substitute 8 is injected into the degradable tube until the injectable bone substitute fills the entire degradable tube 21, and the bone tunnel is completely filled with the injectable bone substitute (such as bone cement, etc.) (see fig. 24).
g. And (4) finishing a vertebral body bone cement shield (bone tunneling) structure (bone cement filling). When the injectable bone substitute is cured, the remaining structure within the vertebral body is the outer layer (degradable tube) and the bone substitute inside it.
As indicated above. In the technical scheme of the invention, the following two devices are realized:
1) when the requirements on mechanical bearing are high, a bone tunnel does not need to be drilled after the distraction of the vertebral body cancellous bone.
The bone cement reinforced spiral tube dual injection system given in example 1 may be used at this time. This scheme is through great bone cement quantity, and the reinforcement of supplementary peek material outer tube can form stronger centrum and consolidate and the bearing effect.
2) When the osteoporosis or the bone loss of the spongy bone of the vertebral body is still enough and the requirement on the mechanical bearing is still enough, the technical scheme needs to drill a bone tunnel for the target vertebral body after two adjacent vertebral bodies are propped open.
The guide wire guided flexible bone cement shield system of example 2 may be used at this time. The scheme integrates tunneling of the bone tunnel and injection of bone cement through convenient operation.
The technical scheme adopted by the invention has the beneficial effects that:
1) percutaneous minimally invasive injection/push:
both a spiral tube double-injection system for reinforcing bone cement and a flexible bone cement shield system guided by a guide wire can be completed in a percutaneous minimally invasive injection mode.
2) The shaping can be planned:
the two modes can customize the structure, shape and size of the injection region before operation according to the representation of the imaging, and can be perfectly molded according to the existing fixed space shape in the operation and is consistent with the in vitro scheme.
3) The forming is controllable:
a) the implantation position is controllable: evaluating the damaged area according to the compression damage degree of the vertebral body; accurately positioning the region to be distracted (the relatively complete region of the upper and lower cortical bones) without affecting the rest of the region
b) The injection amount is controllable: the implant is localized to a specific area. The injection amount of the required bone cement can be accurately calculated; perfectly solves various complications caused by bone cement leakage and has uncontrollable mechanical supporting effect.
c) The spreading (forming) effect is controllable: a reduction scheme is formulated before an operation according to the damage conditions of adjacent segment intervertebral discs and end plates; the expected expanding/resetting effect can be accurately achieved by selecting the most suitable type of the peek spiral body.
d) The mechanical support property is controllable: the injected Peek spiral body is of a closed structure, the using amount and dispersion path of the bone cement can be strictly limited through the gap reserved for the bone cement in the Peek spiral body, and the composite support system of the Peek spiral body and the bone cement can achieve mechanical strength completely consistent with in vitro simulation.
4) The implementation mode is flexible and selectable:
a) the bone cement reinforced helical tube dual injection system can be used for vertebroplasty requiring more powerful support.
b) The flexible bone cement shield system guided by the guide wire can be used for vertebroplasty needing more convenient and integrated operation.
According to the technical scheme, the degradable hollow tube with the memory alloy guide needle serving as a 'needle core' is pushed/injected to a designated position in a vertebral body to form a boundary of a bone cement filling space or serve as a boundary fence of the filling space; at the designated position in the vertebral body, the injectable bone substitute is filled with the biocompatible polymer hollow tube and the filling space surrounded by the biocompatible polymer hollow tube. The bone cement injection device enables a bone cement injection area to have planning performance, and integrates multiple operations of puncture, distraction, plant and bone cement injection, molding and the like in vertebroplasty.
The invention can be widely applied to the field of design and manufacture of orthopedic implant injection devices.
Claims (10)
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| CN111466995A (en) * | 2020-05-28 | 2020-07-31 | 四川大学华西医院 | Femoral head reaming tool |
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