CN117281603A - Vertebral body expansion device for bone filler injection and control method thereof - Google Patents
Vertebral body expansion device for bone filler injection and control method thereof Download PDFInfo
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- CN117281603A CN117281603A CN202211737060.2A CN202211737060A CN117281603A CN 117281603 A CN117281603 A CN 117281603A CN 202211737060 A CN202211737060 A CN 202211737060A CN 117281603 A CN117281603 A CN 117281603A
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- vertebral body
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- mesh bag
- middle sleeve
- outer tube
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- 210000000988 bone and bone Anatomy 0.000 title claims abstract description 186
- 239000000945 filler Substances 0.000 title claims abstract description 166
- 238000002347 injection Methods 0.000 title claims abstract description 49
- 239000007924 injection Substances 0.000 title claims abstract description 49
- 238000000034 method Methods 0.000 title description 23
- 239000000463 material Substances 0.000 claims description 25
- 239000000956 alloy Substances 0.000 claims description 13
- 239000010935 stainless steel Substances 0.000 claims description 13
- 229910001220 stainless steel Inorganic materials 0.000 claims description 10
- 229910001285 shape-memory alloy Inorganic materials 0.000 claims description 8
- 229910001069 Ti alloy Inorganic materials 0.000 claims description 6
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 5
- 239000007769 metal material Substances 0.000 claims description 3
- 229910001256 stainless steel alloy Inorganic materials 0.000 claims description 3
- 230000013011 mating Effects 0.000 claims description 2
- 238000011084 recovery Methods 0.000 abstract description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 14
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 14
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 14
- 230000036760 body temperature Effects 0.000 description 10
- 230000000670 limiting effect Effects 0.000 description 9
- 239000002639 bone cement Substances 0.000 description 8
- 238000010586 diagram Methods 0.000 description 7
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- 230000000694 effects Effects 0.000 description 6
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- 238000001356 surgical procedure Methods 0.000 description 6
- 230000006870 function Effects 0.000 description 5
- 206010010214 Compression fracture Diseases 0.000 description 4
- 229910045601 alloy Inorganic materials 0.000 description 4
- 210000005077 saccule Anatomy 0.000 description 4
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- 229920000642 polymer Polymers 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 239000004925 Acrylic resin Substances 0.000 description 2
- 229920000178 Acrylic resin Polymers 0.000 description 2
- 208000001132 Osteoporosis Diseases 0.000 description 2
- 230000004308 accommodation Effects 0.000 description 2
- 229910000389 calcium phosphate Inorganic materials 0.000 description 2
- 239000001506 calcium phosphate Substances 0.000 description 2
- 235000011010 calcium phosphates Nutrition 0.000 description 2
- 239000002131 composite material Substances 0.000 description 2
- 229910052588 hydroxylapatite Inorganic materials 0.000 description 2
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 description 2
- 238000012827 research and development Methods 0.000 description 2
- 230000007704 transition Effects 0.000 description 2
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 2
- 208000031636 Body Temperature Changes Diseases 0.000 description 1
- 208000010392 Bone Fractures Diseases 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7071—Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; Tools therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7094—Solid vertebral fillers; devices for inserting such fillers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, setting implements or the like
- 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
- A61B17/8811—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer tip, i.e. the part inserted into or onto the bone
Landscapes
- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Medical Informatics (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Neurology (AREA)
- Prostheses (AREA)
Abstract
The invention belongs to the technical field of vertebral body surgical tools, and discloses a vertebral body expansion device for injecting bone filler, which is of a main body structure, comprises a mesh bag and a bracket, is used for expanding in a vertebral body, recovering the height of the vertebral body and providing an accommodating space for the bone filler; the connecting tube assembly is an auxiliary structure and comprises an outer tube assembly and a middle sleeve assembly, and is used for assisting the vertebral body expanding device to enter the vertebral body, expanding the vertebral body expanding device and providing an injection channel of bone filler. The invention provides a cavity into which bone filler is injected, so that the risk of leakage of the bone filler is greatly reduced, the injection pressure of the bone filler is greatly reduced, and the bone filler can be better anchored in a vertebral body; the retraction of the cavity filled with bone filler is avoided, and the physiological height of the vertebral body is better recovered and ensured; the supporting function of the bracket effectively avoids the retraction of the cavity and ensures the recovery of the physiological height of the vertebral body.
Description
Technical Field
The invention belongs to the technical field of vertebral body surgical tools, and particularly relates to a vertebral body expansion device for bone filler injection and a control method thereof.
Background
At present, vertebral compression fracture caused by osteoporosis is frequently generated in the elderly, and patients suffering from the disease are rapidly increasing as the population ages. Current surgical treatments are percutaneous vertebroplasty (percutaneous vertebroplasty, PVP), percutaneous kyphoplasty (percutaneous kyphoplasty, PKP) and novel bone pocket filling vertebroplasty (Vesselplasty). The three operations have the common points that bone fillers (common bone cements such as acrylic resin bone cement, calcium phosphate bone cement and hydroxyapatite composite bone cement) are injected into the vertebral body by means of external force so as to achieve the effects of repairing the height of the vertebral body, enhancing the strength and stability of the vertebral body and relieving the pain of the waist and back of a patient, thereby treating the vertebral body compression fracture caused by osteoporosis. These three procedures all have drawbacks, as will be described one by one:
in PVP surgery, the conventional surgical steps are:
(1) Inserting the puncture needle into the vertebral body, then pulling out the inner tube of the puncture needle, and leaving the outer tube of the puncture needle in the vertebral body;
(2) Inserting a guide wire along the outer tube of the puncture needle, and pulling out the outer tube of the puncture needle;
(3) Inserting the expander into the vertebral body along the guide wire, respectively pulling out the guide wire and the inner tube of the expander, and leaving the outer tube of the expander in the vertebral body to form a channel for injecting bone filler;
(4) Inserting a bone drill along the outer tube of the expander, rotating the bone drill to drill holes, and then pulling out the bone drill, wherein the outer tube of the expander is left in the vertebral body;
(5) Injecting a bone filler into the vertebral body along the outer tube of the dilator;
(6) And withdrawing the outer tube of the dilator after the bone filler injection is completed.
Compression fracture of the vertebral body can cause the vertebral body to generate cracks, injected bone filler cannot be immediately solidified, and when the fluidity is high, the bone filler can enter tissues near the vertebral body along the cracks of the vertebral body, and the phenomenon is called bone filler leakage. Bone filler leakage can produce side effects such as necrosis of surrounding bone, bone filler syndrome in the human body, etc. The biggest disadvantage of PVP technique is that bone filler leakage easily occurs, and the probability of bone filler leakage can be as high as more than 80%. Second, the injection pressure of the bone filler is also high.
In PKP surgery, the conventional surgical steps are:
(1) Inserting the puncture needle into the vertebral body, then pulling out the inner tube of the puncture needle, and leaving the outer tube of the puncture needle in the vertebral body;
(2) Inserting a guide wire along the outer tube of the puncture needle, and pulling out the outer tube of the puncture needle;
(3) Inserting the expander into the vertebral body along the guide wire, respectively pulling out the guide wire and the inner tube of the expander, and leaving the outer tube of the expander in the vertebral body to form a channel for injecting bone filler;
(4) Inserting a bone drill along the outer tube of the expander, rotating the bone drill to drill holes, and then pulling out the bone drill, wherein the outer tube of the expander is left in the vertebral body;
(5) Connecting a pressure pump to the balloon, performing evacuation operation on the balloon, inserting the balloon into the vertebral body along the outer tube of the expander, operating the pressure pump to expand the balloon, then operating the pressure pump to shrink the balloon, and extracting the balloon;
(6) Injecting a bone filler into the vertebral body along the outer tube of the dilator;
(7) And withdrawing the outer tube of the dilator after the bone filler injection is completed.
PKP is also a procedure in which a bone filler injection channel is first established, as is PVP. Then the balloon is used for expanding to form a cavity, the balloon is withdrawn, bone filler is injected, and finally the instrument is withdrawn. PKP surgery adds a procedure to the balloon compared to PVP surgery. After the saccule enters the vertebral body, the saccule expands to push away bone, and after the saccule is withdrawn, a cavity is formed in the vertebral body. The cavity greatly reduces the injection pressure of the bone filler and thus the risk of leakage of the bone filler is reduced. Secondly, the spongy bone around the cavity is compacted due to the fact that the spongy bone is pushed away by the saccule, and leakage of bone filler can be effectively prevented. However, the disadvantage is that after balloon withdrawal, the retraction of the cavity is detrimental to the injection of bone filler and the restoration of the vertebral body to a level not expected due to the lack of a supporting cavity.
There is another surgical approach, new bone capsular bag filling vertebroplasty (vesselplay), which, unlike PVP and PKP procedures, involves more capsular bags (or mesh bags). In this procedure, the procedure of creating a channel for bone filler injection is consistent with PVP and PKP procedures. The capsular bag is then inserted into the vertebral body along the outer tube of the expander, the instrument is withdrawn after the bone filler is injected, and the bone filler and capsular bag remain in the vertebral body. The bag is made of polymer woven fabric and is provided with a plurality of small holes. One of the advantages of the pouch is that it controls the outflow of bone filler, effectively preventing the bone filler from leaking. The second advantage is that the small holes allow better integration of the bone filler with cancellous bone after outflow, and the larger surface area of the bone filler enables better anchoring of the entire device in the vertebral body. The disadvantage is that the lack of a balloon-forming procedure as in PKP, ultimately, the restoration of the vertebral body is not high enough.
Aiming at the problems in the three techniques, a vertebral body expanding device for injecting bone filler, which can be flexibly used, is convenient to operate and has small side effect, is needed.
Through the above analysis, the problems and defects existing in the prior art are as follows: in the vertebral compression fracture operation, the bone filler is easy to leak, the injection of the bone filler is not facilitated, and the recovery height of the vertebral body is insufficient.
Disclosure of Invention
The invention provides a vertebral body expansion device for injecting bone filler, which aims at the problems existing in the prior art.
The present invention is achieved by a vertebral body expansion device for bone filler injection comprising:
the vertebral body expanding device is of a main body structure and comprises a net bag and a bracket, and is used for expanding in a vertebral body, restoring the height of the vertebral body and providing an accommodating space for bone filler;
the connecting pipe assembly is an auxiliary structure and comprises an outer pipe assembly and a middle sleeve assembly, and is used for assisting the vertebral body expanding device to enter the vertebral body, expanding the vertebral body expanding device and providing an injection channel of bone filler.
Further, the mesh bag comprises a mesh bag left end, a mesh bag middle end and a mesh bag right end, wherein the mesh bag left end and the mesh bag right end are of non-deformable rigid structures, and the mesh bag middle end is of a deformable flexible structure. The left end and the right end of the net bag can be made of metal materials such as stainless steel, titanium alloy and the like, and the middle end of the net bag can be made of PET material.
Further, the pocket left end is provided with pocket left end first round hole, and the pocket middle-end is provided with pocket middle-end first cavity, and the pocket right-hand member is provided with pocket right-hand member first round hole, pocket right-hand member second round hole and pocket right-hand member boss, and the accommodation space of placing the support is constituteed to pocket left end first round hole, pocket middle-end first cavity, pocket right-hand member first round hole and pocket right-hand member second round hole.
Further, the support comprises flexible structure and rigid structure, flexible structure includes first support solid fixed ring and second support solid fixed ring, and the diameter of first support solid fixed ring is less than the diameter of second support solid fixed ring, and the line footpath of both is unanimous, and rigid structure includes articulated first support bracing piece, second support bracing piece and third support bracing piece in proper order. The articulation of the rigid structure, together with the flexible structure, allows the stent to be deformed. The flexible structure can be made of PET material, and the rigid structure can be made of stainless steel and titanium alloy material.
Further, the stent may be formed from a series of filaments arranged in a staggered fashion to form an integral network. The filaments are made of memory alloy materials, and the stent can be spread under the influence of temperature. The material of the bracket can be nickel-titanium alloy.
Further, the stent may be a helical structure formed of one filament. The filaments are made of memory alloy materials, and the stent can be spread under the influence of temperature. The material of the bracket can be nickel-titanium alloy.
Further, the support comprises a support shaft, a rotating shaft assembly, a support rod, a support plate, a sleeve and a locking structure. The support rod is hinged with the support shaft, the support rod is hinged with the support plate, and the support rod is hinged with the sleeve, and the hinge is realized through the rotating shaft component. The centers of the sleeve and the locking structure are provided with round holes which are sleeved on the supporting shaft. When the locking structure moves on the support shaft, the sleeve, the support rod and the support plate also move, so that the support is deformed.
Further, the outer tube assembly comprises an outer tube and a joint, the outer tube is of a tubular structure, an outer tube groove is formed in the left end of the outer tube and is used for being matched with a boss at the right end of a mesh bag of the mesh bag, so that the outer tube and the mesh bag can not rotate relatively, an outer tube first channel is further formed in the outer tube, the inner diameter of the outer tube first channel is slightly larger than the outer diameter of the middle sleeve, and the middle sleeve can move in the outer tube first channel; the outer tube can be made of stainless steel.
Further, the inside joint is provided with joint first passageway, joint second passageway, joint third passageway, and the internal diameter of joint first passageway slightly is greater than the external diameter of outer tube, and the two link together through bonding, and the internal diameter of joint second passageway slightly is greater than well sheathed tube external diameter, and well sleeve pipe can remove and rotate in the sleeve pipe passageway, and joint third passageway makes well sleeve pipe subassembly can remove and rotate. The joint can be made of PC material.
Further, a joint boss matched with the middle sleeve component is further arranged on the joint, and a joint handle convenient to hold is also arranged on the joint.
Further, the middle sleeve assembly comprises a middle sleeve and a luer connector, wherein the middle sleeve is used for pushing the bracket and triggering the bracket to open, a conveying channel is provided for bone filler, and the luer connector is used for being connected with a bone filler injector and providing a limiting effect for the middle sleeve assembly.
Further, well sleeve pipe is tubular structure, is provided with the well sleeve pipe round hole that provides the conveying channel for bone filler in the well sleeve pipe, well sleeve pipe mid portion is provided with well sleeve pipe screw thread, well sleeve pipe screw thread and the internal thread cooperation that sets up on the first round hole of pocket right-hand member, well sleeve pipe screw thread left side is provided with well sleeve pipe step, well sleeve pipe step and support contact. In another form, the middle sleeve is not threaded, but rather is provided with a middle sleeve boss that mates with the locking feature recess. The middle sleeve can be made of stainless steel materials.
Further, the luer connector is provided with a luer connector first round hole, a luer connector bottom surface, a luer connector thread and a luer connector second round hole, the luer connector first round hole is bonded with the middle sleeve and fixed, the luer connector thread is used for being connected with a bone filler injector, and the bone filler injector enables bone filler to enter the inside of the mesh bag along the luer connector second round hole and the middle sleeve round hole respectively. The luer connector can be made of PC material.
Another object of the present invention is to provide a control method of a vertebral body expansion device for bone filler injection, the control method of the vertebral body expansion device for bone filler injection comprising:
Holding the connector handle by hand, rotating the luer connector clockwise, and rotating the middle sleeve, wherein the middle sleeve is matched with the mesh bag through threads, the middle sleeve moves leftwards, the middle sleeve step pushes the right end of the bracket to move leftwards, and the bracket is gradually spread; for stents in the form of memory alloys, the stent is expanded by the body temperature of the human body.
Step two, the middle sleeve rotates to a certain position, the bottom surface of the luer connector is contacted with the connector boss, the middle sleeve can not rotate clockwise any more due to the limiting function of the connector boss, at the moment, the right end of the bracket enters a second round hole at the right end of the mesh bag, and the mesh bag is propped open by the bracket; for stents in the form of memory alloys, the stent is expanded by the body temperature of the human body.
Thirdly, after the bone filler injector is connected with the luer connector thread, injecting the bone filler leftwards along the middle sleeve, and injecting the bone filler while rotating the middle sleeve anticlockwise, so that the bone filler is uniformly distributed in the mesh bag;
and fourthly, the bone filler flows out along the gap of the mesh bag, the middle sleeve is continuously rotated anticlockwise, when the middle sleeve and the mesh bag are not in threaded connection any more, the outer tube and the middle sleeve are withdrawn together, the bone filler flows out through the mesh bag and is combined with cancellous bone, after the bone filler is completely solidified, the mesh bag and the bracket are arranged in the bone filler, and the whole device can be better anchored in a vertebral body.
Or:
holding the connector handle by hand, rotating the luer connector clockwise, and rotating the middle sleeve, wherein the middle sleeve moves leftwards due to the fact that the locking structure is matched with the mesh bag through threads, the middle sleeve step pushes the right end of the support to move leftwards, and the support is gradually spread;
step two, the middle sleeve rotates to a certain position, the bottom surface of the luer connector is contacted with the connector boss, the middle sleeve can not rotate clockwise any more due to the limiting function of the connector boss, at the moment, the right end of the bracket enters a second round hole at the right end of the mesh bag, and the mesh bag is propped open by the bracket;
thirdly, after the bone filler injector is connected with the luer connector thread, bone filler is injected leftwards along the middle sleeve;
and step four, after the bone filler is injected, the bone filler flows out along the mesh bag gaps, and the outer tube and the middle sleeve are withdrawn together. The bone filler is combined with cancellous bone after flowing out through the mesh bag, and when the bone filler is completely solidified, the mesh bag and the bracket are arranged in the bone filler, so that the whole device can be better anchored in the vertebral body.
In combination with the technical scheme and the technical problems to be solved, the technical scheme to be protected has the following advantages and positive effects:
first, aiming at the technical problems in the prior art and the difficulty in solving the problems, the technical problems solved by the technical proposal of the invention are analyzed in detail and deeply by tightly combining the technical proposal to be protected, the results and data in the research and development process, and the like, and some technical effects brought after the problems are solved have creative technical effects. The specific description is as follows:
The invention provides a vertebral body expanding device for injecting bone filler, which can restore the height of a vertebral body, reduce the leakage of the bone filler, enable the bone filler to be better anchored in the vertebral body, is simple to operate and reduces the operation risk.
Compared with PVP (polyvinyl pyrrolidone) surgery, the cavity for injecting the bone filler is provided, so that the risk of leakage of the bone filler is greatly reduced, the injection pressure of the bone filler is greatly reduced, and the bone filler can be better anchored in a vertebral body;
compared with PKP (bone cement paste) operation, the retraction of the cavity injected with bone filler is avoided, and the physiological height of the vertebral body is better recovered and ensured;
compared with Vesselplasty, the support function of the support effectively avoids retraction of the cavity and ensures recovery of the physiological height of the vertebral body. A cavity into which bone filler is injected is provided, reducing the injection pressure of the bone filler.
The mesh bag coating of the vertebral body expanding device can prevent bone filler from leaking and avoid tissue damage near the vertebral body.
Secondly, the technical scheme is regarded as a whole or from the perspective of products, and the technical scheme to be protected has the following technical effects and advantages:
from a product perspective, a relatively perfect product is provided, the disadvantages of PVP, PKP and Vesselplasty are overcome, and doctors and patients are benefited.
Thirdly, as inventive supplementary evidence of the claims of the present invention, the following important aspects are also presented:
the technical scheme of the invention fills the technical blank in the domestic and foreign industries:
the technical scheme of the invention is characterized in that the bracket adopts a mechanical or memory alloy form, and the bracket is similar in domestic and foreign industries.
Drawings
FIG. 1 (a) is a schematic illustration of a vertebral body expansion device for bone filler injection according to an embodiment of the present invention;
FIG. 1 (b) is a schematic cross-sectional view of a vertebral body expansion device for bone filler injection according to an embodiment of the present invention;
FIG. 2 (a) is a schematic view of the structure of the mesh bag according to the embodiment of the present invention when the mesh bag is contracted;
fig. 2 (b) is a schematic structural diagram of the mesh bag according to the embodiment of the present invention when the mesh bag is opened;
FIG. 2 (c) is a schematic cross-sectional view of a mesh bag according to an embodiment of the present invention when the mesh bag is opened;
FIG. 3 (a) is a schematic view of a structure of a stent according to an embodiment of the present invention when the stent is contracted;
fig. 3 (b) is a schematic structural diagram of a stent according to an embodiment of the present invention when the stent is opened;
FIG. 3 (c) is a schematic diagram of a bracket according to an embodiment of the present invention;
FIG. 4 (a) is a schematic structural view of an outer tube assembly according to an embodiment of the present invention;
FIG. 4 (b) is a schematic cross-sectional view of an outer tube assembly provided by an embodiment of the present invention;
FIG. 5 (a) is a schematic structural diagram of a middle sleeve assembly according to an embodiment of the present invention;
FIG. 5 (b) is a schematic cross-sectional view of a middle sleeve assembly according to an embodiment of the present invention;
FIG. 6 (a) is a cross-sectional view of a stent according to an embodiment of the present invention when contracted;
FIG. 6 (b) is a partial schematic view of the mesh bag when the stent is contracted according to the embodiment of the present invention;
FIG. 6 (c) is a cross-sectional view of a stent according to an embodiment of the present invention when expanded;
FIG. 6 (d) is a partial schematic view of the mesh bag when the stent is expanded according to the embodiment of the present invention;
FIG. 7 (a) is a schematic view of a structure of a stent according to an embodiment of the present invention when the stent is contracted;
fig. 7 (b) is a schematic structural diagram of a stent according to an embodiment of the present invention when the stent is opened;
FIG. 8 (a) is a cross-sectional view of a stent according to an embodiment of the present invention when contracted;
FIG. 8 (b) is a partial schematic view of the mesh bag at the time of stent shrinkage provided by an embodiment of the present invention;
FIG. 8 (c) is a cross-sectional view of a stent according to an embodiment of the present invention when expanded;
FIG. 8 (d) is a partial schematic view of the mesh bag when the stent is expanded according to the embodiment of the present invention;
FIG. 9 (a) is a schematic view of a structure of a stent according to an embodiment of the present invention when the stent is contracted;
fig. 9 (b) is a schematic structural diagram of a stent according to an embodiment of the present invention when the stent is opened;
FIG. 10 (a) is a cross-sectional view of a stent according to an embodiment of the present invention when contracted;
FIG. 10 (b) is a partial schematic view of the mesh bag at the time of stent shrinkage provided by an embodiment of the present invention;
FIG. 10 (c) is a cross-sectional view of a stent according to an embodiment of the present invention when expanded;
FIG. 10 (d) is a partial schematic view of the mesh bag when the stent is expanded according to the embodiment of the present invention;
FIG. 11 (a) is a schematic view of a structure of a stent according to an embodiment of the present invention when the stent is contracted;
fig. 11 (b) is a schematic structural diagram of a stent according to an embodiment of the present invention when the stent is opened;
FIG. 11 (c) is a schematic view of a stent composition according to an embodiment of the present invention;
FIG. 12 (a) is a schematic view of a middle sleeve assembly according to an embodiment of the present invention;
FIG. 12 (b) is a schematic cross-sectional view of a middle sleeve assembly according to an embodiment of the present invention;
FIG. 13 (a) is a cross-sectional view of a stent according to an embodiment of the present invention when contracted;
FIG. 13 (b) is a partial schematic view of the mesh bag at the time of stent shrinkage provided by an embodiment of the present invention;
FIG. 13 (c) is a cross-sectional view of a stent according to an embodiment of the present invention when expanded;
FIG. 13 (d) is a partial schematic view of the mesh bag when the stent is expanded according to the embodiment of the present invention;
in the figure: 1. a vertebral body expansion device; 11. a mesh bag; 111. the left end of the net bag; 1111. the left end of the net bag is provided with a first round hole; 112. the middle end of the net bag; 1121. a first cavity at the middle end of the net bag; 113. the right end of the net bag; 1131. the right end of the net bag is provided with a first round hole; 1132. the second round hole is formed in the right end of the mesh bag; 1133. a boss at the right end of the net bag; 12. a bracket; 121. a first bracket fixing ring; 122. a second bracket fixing ring; 123. a first support bar; 124. a second support bar; 125. a third support bar; 12a, a bracket; 12b, a bracket; 12c, a bracket; 12c1, a support shaft; 12c11, a first cylinder of a support shaft; 12c12, a second cylinder of the support shaft; 12c13, a third cylinder of the support shaft; 12c14, a support shaft groove; 12c2, a spindle assembly; 12c3, support bars; 12c4, a support plate; 12c5, a sleeve; 12c6, locking structure; 12c61, locking structure threads; 12c62, locking structure grooves; 2. a connecting tube assembly; 21. an outer tube assembly; 211. an outer tube; 2111. an outer tube groove; 2112. an outer tube first passage; 212. a joint; 2121. a joint first passage; 2122. a joint second channel; 2123. a joint third channel; 2124. a joint boss; 2125. a joint handle; 22. a middle sleeve assembly; 221. a middle sleeve; 2211. a middle sleeve round hole; 2212. a middle sleeve step; 2213. middle sleeve threads; 222. a luer fitting; 2221. a luer fitting first round hole; 2222. a luer fitting bottom surface; 2223. luer fitting threads; 2224. a luer fitting second round hole; 22a, a middle sleeve assembly; 22a1, a middle sleeve; 22a11, a middle sleeve round hole; 22a12, middle sleeve boss.
Detailed Description
The present invention will be described in further detail with reference to the following examples in order to make the objects, technical solutions and advantages of the present invention more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the invention.
The control method of the vertebral body expansion device for bone filler injection provided by the embodiment of the invention comprises the following steps:
holding the connector handle by hand, rotating the luer connector clockwise, and rotating the middle sleeve, wherein the middle sleeve is matched with the mesh bag through threads, the middle sleeve moves leftwards, the middle sleeve step pushes the right end of the bracket to move leftwards, and the bracket is gradually spread; for stents in the form of memory alloys, the stent is expanded by the body temperature of the human body.
Step two, the middle sleeve rotates to a certain position, the bottom surface of the luer connector is contacted with the connector boss, the middle sleeve can not rotate clockwise any more due to the limiting function of the connector boss, at the moment, the right end of the bracket enters a second round hole at the right end of the mesh bag, and the mesh bag is propped open by the bracket; for stents in the form of memory alloys, the stent is expanded by the body temperature of the human body.
Thirdly, after the bone filler injector is connected with the luer connector thread, injecting the bone filler leftwards along the middle sleeve, and injecting the bone filler while rotating the middle sleeve anticlockwise, so that the bone filler is uniformly distributed in the mesh bag;
And fourthly, the bone filler flows out along the gap of the mesh bag, the middle sleeve is continuously rotated anticlockwise, when the middle sleeve and the mesh bag are not in threaded connection any more, the outer tube and the middle sleeve are withdrawn together, the bone filler flows out through the mesh bag and is combined with cancellous bone, after the bone filler is completely solidified, the mesh bag and the bracket are arranged in the bone filler, and the whole device can be better anchored in a vertebral body.
The control method of the vertebral body expansion device for bone filler injection provided by the embodiment of the invention comprises the following steps:
holding the connector handle by hand, rotating the luer connector clockwise, and rotating the middle sleeve, wherein the middle sleeve moves leftwards due to the fact that the locking structure is matched with the mesh bag through threads, the middle sleeve step pushes the right end of the support to move leftwards, and the support is gradually spread;
step two, the middle sleeve rotates to a certain position, the bottom surface of the luer connector is contacted with the connector boss, the middle sleeve can not rotate clockwise any more due to the limiting function of the connector boss, at the moment, the right end of the bracket enters a second round hole at the right end of the mesh bag, and the mesh bag is propped open by the bracket;
thirdly, after the bone filler injector is connected with the luer connector thread, bone filler is injected leftwards along the middle sleeve;
and step four, after the bone filler is injected, the bone filler flows out along the mesh bag gaps, and the outer tube and the middle sleeve are withdrawn together. The bone filler is combined with cancellous bone after flowing out through the mesh bag, and when the bone filler is completely solidified, the mesh bag and the bracket are arranged in the bone filler, so that the whole device can be better anchored in the vertebral body.
In order to fully understand how the invention may be embodied by those skilled in the art, this section is an illustrative embodiment in which the claims are presented for purposes of illustration.
Example 1
As shown in fig. 1 (a) and 1 (b), the vertebral body expansion device for bone filler injection according to the embodiment of the present invention includes a vertebral body expansion device 1 and a connection tube assembly 2. The vertebral body expansion device 1 comprises a mesh bag 11 and a bracket 12, is a main body structure for being spread in the vertebral body, provides a containing cavity for bone filler, and finally remains in the vertebral body. The connecting tube assembly 2 includes an outer tube assembly 21 and a middle cannula assembly 22, which are auxiliary structures for assisting the vertebral body expansion device 1 in accessing the vertebral body, distracting the vertebral body expansion device 1, and providing an injection passage for bone filler. The bone filler may be acrylic resin bone cement, calcium phosphate bone cement, or hydroxyapatite composite bone cement.
Fig. 2 (a) and 2 (b) are schematic structural views of the mesh bag 11 when contracted and when expanded, respectively, and fig. 2 (c) is a schematic sectional view of the mesh bag when expanded. The mesh bag 11 is divided into a left mesh bag end 111, a middle mesh bag end 112 and a right mesh bag end 113, wherein the left mesh bag end 111 and the right mesh bag end 113 are of a rigid structure, and the middle mesh bag end 112 is of a flexible structure:
The left end 111 of the mesh bag is provided with a first round hole 1111 at the left end of the mesh bag, which is of a hollow structure and provides a containing space for the bracket 12. The first circular hole 1111 at the left end of the mesh bag is communicated with the hollow structure of the middle end 112 of the mesh bag. The left end 111 of the mesh bag can be made of metal materials such as stainless steel, titanium alloy and the like.
The bag-in-end 112 is provided with a bag-in-end first cavity 1121. The middle end 112 of the mesh bag is woven by polymer and is in a revolving structure, and two ends are respectively fixed with the left end 111 and the right end 113 of the mesh bag, so that a first cavity 1121 of the middle end of the mesh bag is formed. The middle end 112 of the mesh bag is soft and can deform due to the adoption of a polymer braided fabric structure, so that the mesh bag can be changed from the contracted state of fig. 2 (a) to the expanded state of fig. 2 (b); and the slit therein enables the bone filler to flow outwardly from the first cavity 1121 at the mid-end of the mesh bag. The mesh bag middle end 112 presents a quadrilateral mesh shape, and the mesh of the mesh bag middle end 112 is not drawn for convenience in the following description of the principles of the present patent. The mesh bag middle end 112 can be made of PET material, and the mesh number of the mesh bag can be 80+/-10 meshes so as to control the outflow amount of bone filling.
The right end 113 of the mesh bag is provided with a first circular hole 1131 at the right end of the mesh bag, and is provided with internal threads. The right end 113 of the mesh bag is also provided with a second round hole 1132 at the right end of the mesh bag. The second circular hole 1132 at the right end of the mesh bag is identical to the inner diameter of the first circular hole 1111 at the left end of the mesh bag, and both provide accommodation space for the bracket 12. The right end 113 of the mesh bag is further provided with a boss 1133 at the right end of the mesh bag, which cooperates with the outer tube 211 to prevent the mesh bag 11 and the outer tube 211 from rotating relatively. The first circular hole 1111 at the left end of the mesh bag, the first hollow cavity 1121 at the middle end of the mesh bag, the first circular hole 1131 at the right end of the mesh bag and the second circular hole 1132 at the right end of the mesh bag provide a complete accommodating space for the bracket 12. The right end 113 of the mesh bag is identical in material to the left end 111 of the mesh bag.
Fig. 3 (a) to 3 (c) are schematic views of a support 12, the support 12 being composed of a flexible structure and a rigid structure:
the flexible structure comprises a first bracket fixing ring 121 and a second bracket fixing ring 122, wherein the diameter of the first bracket fixing ring 121 is smaller than that of the second bracket fixing ring 122, but the diameters of the first bracket fixing ring and the second bracket fixing ring are consistent. There are two flexible structures available: one that is elastic in itself, remains circular both when contracted (left view in fig. 3 (a)) and when expanded (fig. 3 (b)); the other is not elastic but can be deformed, and is not circular when contracted (right view in fig. 3 (a)), and remains circular when expanded (fig. 3 (b)). The flexible structure may be made of PET material.
The rigid structure includes a first support strut 123, a second support strut 124, and a third support strut 125, all of which have uniform diameters. The first support bar 123 is hinged with the second support bar 124, and the second support bar 124 is hinged with the third support bar 125. The cooperation of the flexible and rigid structures enables the stent 12 to transition from the contracted state of fig. 3 (a) to the expanded state of fig. 3 (b). Stainless steel and titanium alloy materials can be used for the rigid structure.
Fig. 4 (a) and 4 (b) are schematic structural views of the outer tube assembly 21, including the outer tube 211 and the joint 212:
The outer tube 211 has a tubular structure, and an outer tube groove 2111 is provided at the left end thereof for cooperating with a boss 1133 at the right end of the mesh bag 11, so that the outer tube 211 and the mesh bag 11 cannot rotate relatively. The outer tube 211 is also provided with an outer tube first channel 2112 having an inner diameter slightly larger than the outer diameter of the middle sleeve 221, the middle sleeve 221 being movable within the outer tube first channel 2112. The outer tube 211 may be made of stainless steel.
Three working channels are provided in the joint 212, namely a joint first channel 2121, a joint second channel 2122 and a joint third channel 2123. The inner diameter of the joint first passage 2121 is slightly larger than the outer diameter of the outer tube 211, and the two are joined together by bonding. The inner diameter of the joint second channel 2122 is slightly larger than the outer diameter of the middle sleeve 221, and the middle sleeve 221 is movable and rotatable within the joint second channel 2122. The joint third passage 2123 enables movement and rotation of the middle sleeve assembly 22. Fitting 212 also has a fitting boss 2124 provided thereon for mating with the middle sleeve assembly 22. The connector 212 is also provided with a connector handle 2125 for easy gripping. The joint 212 may be made of PC material.
Fig. 5 (a) and 5 (b) are schematic structural views of the middle sleeve assembly 22. The middle sleeve assembly 22 consists of a middle sleeve 221 and a luer fitting 222:
The middle sleeve 221 has a tubular structure and is provided with a middle sleeve round hole 2211 for providing a conveying channel for bone filler. The middle part is provided with a middle sleeve thread 2213 which is matched with the inner thread arranged on the first round hole 1131 at the right end of the mesh bag, so that the middle sleeve 221 and the mesh bag 11 can rotate relatively. A middle sleeve step 2212 is provided on the left side of the middle sleeve thread 2213 in contact with the bracket 12. The middle sleeve 221 may be made of stainless steel.
Luer 222 is provided with luer first circular bore 2221, luer bottom surface 2222, luer threads 2223, and luer second circular bore 2224. Luer first bore 2221 is bonded to and secured to middle cannula 221. Luer bottom surface 2222, when it is in contact with the right side of connector boss 2124 (fig. 4 (b)), intermediate sleeve assembly 22 is not rotatable any further into mesh bag 11. The luer connector threads 2223 are used to connect with a bone filler injector that will cause bone filler to enter the interior of the mesh bag 11 along the luer connector second bore 2224 and the middle cannula bore 2211, respectively. The luer 222 may be a PC material.
Before using the vertebral body expansion device for bone filler injection, a channel should be established for the vertebral body expansion device for bone filler injection, which is the same as the steps (1) - (4) of PVP in the "background art", and will not be described in detail here. The vertebral body expansion device 1 in the contracted state for bone filler injection (fig. 1 (a)) is then left-hand vertebral body expansion device along the channel into the vertebral body. The vertebral body expansion device 1 is now still in a contracted state, as shown in fig. 6 (a) and 6 (b).
Fig. 6 (a) is a cross-sectional view of the stent when contracted, in which both the mesh bag 11 and the stent 12 are in a contracted state. The middle sleeve 221 is matched with the inner thread on the first round hole 1131 at the right end of the net bag through the middle sleeve thread 2213. Both ends of the bracket 12 are respectively contacted with the first round hole 1111 at the left end of the mesh bag and the middle sleeve step 2212.
The middle sleeve 221 is also rotated by holding the connector handle 2125 with one hand and rotating the luer connector 222 clockwise with the other hand, and the middle sleeve 221 moves leftwards due to the threaded engagement of the middle sleeve 221 and the mesh bag 11, and the middle sleeve step 2212 pushes the right end of the support 12 to move leftwards, so that the support 12 is gradually opened. When the middle sleeve 221 is rotated to a certain position (fig. 6 (c) and (d), the grids of the mesh bag 11 are not shown in the two figures for convenience of illustration), the bottom surface 2222 of the luer connector is contacted with the boss 2124 of the connector, the middle sleeve 221 can not rotate clockwise any more due to the limiting effect of the boss 2124 of the connector, at this time, the right end of the bracket 12 enters the second round hole 1132 at the right end of the mesh bag, the bracket 12 is completely opened, and the mesh bag 11 can be opened by the bracket 12. The bracket 12 does not shrink due to the spacing of the first circular hole 1111 at the left end of the mesh bag and the second circular hole 1132 at the right end of the mesh bag. At this time, after the bone filler injector is connected to the luer thread 2223 (fig. 5 b), the bone filler is injected leftward (in the arrow direction of fig. 6 d) along the middle sleeve 221, and the bone filler can be injected while rotating the middle sleeve 221 counterclockwise, so that the bone filler is uniformly distributed in the mesh bag 11. The bone filler can flow out along the slit of the mesh bag 11 but not out of the vertebral body. Since the middle sleeve 221 is rotated continuously counterclockwise during this process, the outer tube 211 can be withdrawn together with the middle sleeve 221 when the middle sleeve 221 and the mesh bag 11 are no longer screwed. When the bone filler has completely solidified, the mesh bag 11 and the scaffold 12 are in the bone filler.
The bone filler is combined with cancellous bone after flowing out through the mesh bag, so that the whole device can be better anchored in the vertebral body, the stability of the vertebral body is improved, and fracture is not generated any more. The device greatly improves the safety and effectiveness of the operation.
Example 2
In embodiment 1, the stent 12 is triggered to open by rotating the middle sleeve 221 to axially move it. In this embodiment, the structure of the stent is changed and the material is a memory alloy, and the structure and material of the rest remain unchanged.
The whole bracket 12a is made of a memory alloy material, and the material can be nickel-titanium alloy. The phase transition temperature of the stent 12a is 36 c and the hysteresis zone temperature is 20 c, i.e. the stent 12a becomes elastic at temperatures exceeding 36 c, providing a supporting force and will not start to soften until the ambient temperature drops from above 36 c to 16 c, i.e. will not shrink again once the stent is deployed in the body. The stent 12a is in a soft state when not in use, and is contracted at the middle position inside the mesh bag 11, and the body temperature triggers the stent 12a to open as shown in fig. 7 (a) and 7 (b).
Before using the vertebral body expansion device for bone filler injection, a channel should be established for the vertebral body expansion device for bone filler injection, which is the same as the steps (1) - (4) of PVP in the "background art", and will not be described in detail here. The vertebral body expansion device 1 in the contracted state for bone filler injection (fig. 1 (a)) is then left-hand vertebral body expansion device along the channel into the vertebral body. The vertebral body expansion device 1 is now still in a contracted state, as shown in fig. 8 (a) and 8 (b).
Fig. 8 (a) is a cross-sectional view of the stent in a contracted state, in which both the mesh bag 11 and the stent 12a are in a contracted state. Since the vertebral body expansion device 1 has been introduced into the vertebral body, the stent 12a will gradually expand under the influence of the body temperature. The stent 12a is fully expanded, and at this time, as shown in fig. 8 (c) and 8 (d), the stent 12a is fully expanded, and the mesh bag 11 is also expanded as the stent 12a is deformed. The whole bracket 12a is made of memory alloy material and is spread under the influence of human body temperature. A cavity is formed in the middle of the holder 12a, and at this time, after the bone filler injector is connected to the luer thread 2223 (fig. 5 b), the bone filler is injected leftward (in the arrow direction of fig. 8 d) along the middle sleeve 221, and the bone filler can be injected while rotating the middle sleeve 221 counterclockwise, so that the bone filler is uniformly distributed in the mesh bag 11. The bone filler can flow out along the slit of the mesh bag 11 but not out of the vertebral body. Since the middle sleeve 221 is rotated continuously counterclockwise during this process, the outer tube 211 can be withdrawn together with the middle sleeve 221 when the middle sleeve 221 and the mesh bag 11 are no longer screwed. When the bone filler has completely solidified, the mesh bag 11 and the scaffold 12 are in the bone filler.
The bracket can also be provided with another structure: the stent 12b is provided in a spiral structure to be expanded in a radial direction when it is compressed by an axial pressure and affected by a human body temperature, as shown in fig. 9 (a) and 9 (b).
Before using the vertebral body expansion device for bone filler injection, a channel should be established for the vertebral body expansion device for bone filler injection, which is the same as the steps (1) - (4) of PVP in the "background art", and will not be described in detail here. The vertebral body expansion device 1 in the contracted state for bone filler injection (fig. 1 (a)) is then left-hand vertebral body expansion device along the channel into the vertebral body. The vertebral body expansion device 1 is now still in a contracted state, as shown in fig. 10 (a) and 10 (b).
The middle sleeve 221 is also rotated by holding the connector handle 2125 with one hand and rotating the luer connector 222 clockwise with the other hand, and the middle sleeve 221 moves leftwards due to the threaded engagement of the middle sleeve 221 and the mesh bag 11, the middle sleeve step 2212 pushes the right end of the support 12b to move leftwards, and the support 12 is gradually opened under the influence of the body temperature. When the middle sleeve 221 rotates to a certain position, the bottom surface 2222 of the luer connector is contacted with the connector boss 2124, the middle sleeve 221 can not rotate clockwise any more due to the limiting effect of the connector boss 2124, and at the moment, the right end of the bracket 12b enters the second round hole 1132 at the right end of the mesh bag, and the bracket 12b is spread. Due to the body temperature, the stent 12b will be fully expanded and the mesh bag 11 will be fully expanded by the stent 12 b. The stent 12b will remain fully distracted at all times even if the body temperature changes. At this time, after the bone filler injector is connected to the luer thread 2223 (fig. 5 b), the bone filler is injected leftward (in the arrow direction of fig. 10 d) along the middle sleeve 221, and the bone filler can be injected while rotating the middle sleeve 221 counterclockwise, so that the bone filler is uniformly distributed in the mesh bag 11. The bone filler can flow out along the slit of the mesh bag 11 but not out of the vertebral body. Since the middle sleeve 221 is rotated continuously counterclockwise during this process, the outer tube 211 can be withdrawn together with the middle sleeve 221 when the middle sleeve 221 and the mesh bag 11 are no longer screwed. When the bone filler is completely solidified, the mesh bag 11 and the scaffold 12b are in the bone filler.
Example 3
In this embodiment, another mechanical form of the bracket is provided, and the material may be stainless steel, as shown in fig. 11 (a) to 11 (c).
The bracket 12c is composed of a support shaft 12c1, a rotating shaft assembly 12c2, a support rod 12c3, a support plate 12c4, a sleeve 12c5 and a locking structure 12c 6.
The support shaft 12c1 is provided with the following structure: a first cylinder 12c11 of the supporting shaft, so that the bracket 12c is fixed at the left end of the mesh bag 11; a support shaft second cylinder 12c12 for making the bracket 12c immovable to the left; a third shaft cylinder 12c13 for supporting the sleeve 12c5 and the locking structure 12c6 to move thereon; the support shaft groove 12c14 is a groove on the support shaft third cylinder 12c13, and bone filler can flow out through the support shaft groove 12c 14.
The rotation shaft assembly 12c2 serves as a hinge to rotate the support shaft 12c1 and the support rod 12c3 with each other, to rotate the support rod 12c3 and the support plate 12c4 with each other, and to rotate the support rod 12c3 and the sleeve 12c5 with each other.
A support rod 12c3 for connecting the support shaft 12c1 and the support plate 12c4, and the support plate 12c4 and the sleeve 12c5.
A support plate 12c4 for opening the mesh bag 11.
The sleeve 12c5 provides support for the support rod 12c3 such that the support rod 12c3 can rotate thereabout.
The locking structure 12c6 and the sleeve 12c5 are sleeved on the locking structure 12c6, the locking structure 12c6 is connected with the mesh bag 11 through the locking structure threads 12c61, when the locking structure 12c6 rotates to move leftwards, the sleeve 12c5 also moves leftwards, and the supporting rod 12c3 is unfolded and drives the supporting plate 12c4 to be unfolded. The locking structure groove 12c62 is fixed in cooperation with the middle sleeve 22a 1.
In this embodiment, there is a variation in the middle sleeve structure in the middle sleeve assembly, as shown in fig. 12 (a) and 12 (b). The middle sleeve assembly 22a is composed of a middle sleeve 22a1 and a luer connector 222, wherein the left end of the middle sleeve 22a1 is a middle sleeve boss 22a12, and the left end of the middle sleeve 22a11 is a middle sleeve round hole.
Before using the vertebral body expansion device for bone filler injection, a channel should be established for the vertebral body expansion device for bone filler injection, which is the same as the steps (1) - (4) of PVP in the "background art", and will not be described in detail here. The vertebral body expansion device 1 in the contracted state for bone filler injection (fig. 1 (a)) is then left-hand vertebral body expansion device along the channel into the vertebral body. At this point the vertebral body expansion device 1 is still in a contracted state, as shown in fig. 13 (a) and 13 (b).
The middle sleeve 22a1 will also rotate when the luer 222 is rotated clockwise with one hand holding the luer handle 2125 and the locking structure 12c6 will also rotate because the middle sleeve boss 22a12 mates with the locking structure groove 12c62 and the middle sleeve 22a1 and locking structure 12c6 will not rotate relative to each other; the locking structure threads 12c61 on the locking structure 12c6 mate with the internal threads on the first circular hole 1131 at the right end of the mesh bag and the locking structure 12c6 will move to the left upon clockwise rotation of the luer fitting 222. The support rod 12c3 will rotate around the support shaft 12c1 and the sleeve 12c5, raising the support plate 12c4 to gradually open the mesh bag 11. When the middle sleeve 22a1 is rotated to a certain position, the luer bottom surface 2222 is in contact with the connector boss 2124, and the middle sleeve 221 cannot be rotated clockwise any more due to the limiting action of the connector boss 2124, and the bracket 12c is fully spread. The bracket 12c will also remain fully open due to the locking action of the locking structure threads 12c61 with the first circular hole 1131 at the right end of the mesh bag. At this time, after the bone filler injector is coupled to the luer thread 2223 (fig. 12 (b)), the bone filler is injected leftward (in the arrow direction of fig. 13 (d)) along the middle sleeve 22a1, and the bone filler is introduced into the mesh bag 11 along the support shaft groove 12c 14. The bone filler can flow out along the slit of the mesh bag 11 but not out of the vertebral body. When the bone filler injection is completed, the outer tube 211 is withdrawn together with the middle sleeve 22a 1. When the bone filler is completely solidified, the mesh bag 11 and the scaffold 12c are in the bone filler.
In order to prove the inventive and technical value of the technical solution of the present invention, this section is an application example on specific products or related technologies of the claim technical solution.
The present patent focuses on the vertebral body expansion device, i.e., the mesh bag and the stent therein. Examples of related applications of MESH bags, such as MESH-HOLD bone-filled MESH bags from Shandong Guanlong medical supplies Co., ltd; examples of relevant applications of scaffolds are, for example, the spineJack System from VEXIM company and OsseoFix from alpha Spine company TM The system.
In the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more; the terms "upper," "lower," "left," "right," "inner," "outer," "front," "rear," "head," "tail," and the like are used as an orientation or positional relationship based on that shown in the drawings, merely to facilitate description of the invention and to simplify the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore should not be construed as limiting the invention. Furthermore, the terms "first," "second," "third," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
The embodiment of the invention has a great advantage in the research and development or use process, and has the following description in combination with data, charts and the like of the test process.
This patent has the practicality, and is specific as follows:
in the design process, the structure is designed according to clinical application and combination practice. Since the key structure is a bracket, a mechanical type such as a jack type is adopted, and the structure has application in life.
The choice of materials is also combined with clinical application, and the materials selected are all available in the art.
The foregoing is merely illustrative of specific embodiments of the present invention, and the scope of the invention is not limited thereto, but any modifications, equivalents, improvements and alternatives falling within the spirit and principles of the present invention will be apparent to those skilled in the art within the scope of the present invention.
Claims (10)
1. A vertebral body expansion device for bone filler injection, the vertebral body expansion device for bone filler injection comprising:
the vertebral body expanding device is of a main body structure and comprises a net bag and a bracket, and is used for expanding in a vertebral body, restoring the height of the vertebral body and providing an accommodating space for bone filler;
The connecting pipe assembly is an auxiliary structure and comprises an outer pipe assembly and a middle sleeve assembly, and is used for assisting the vertebral body expanding device to enter the vertebral body, expanding the vertebral body expanding device and providing an injection channel of bone filler.
2. The vertebral body expansion device for bone filler injection of claim 1, wherein the mesh bag includes a left mesh bag end, a middle mesh bag end, and a right mesh bag end, the left mesh bag end and the right mesh bag end being non-deformable rigid structures, the middle mesh bag end being deformable flexible structures; the left end and the right end of the net bag can be made of metal materials such as stainless steel, titanium alloy and the like, and the middle end of the net bag can be made of PET material.
3. The vertebral body expansion device for bone filler injection of claim 2, wherein the left end of the mesh bag is provided with a first circular hole at the left end of the mesh bag, the middle end of the mesh bag is provided with a first hollow hole at the middle end of the mesh bag, the right end of the mesh bag is provided with a first circular hole at the right end of the mesh bag, a second circular hole at the right end of the mesh bag and a boss at the right end of the mesh bag, and the first circular hole at the left end of the mesh bag, the first hollow hole at the middle end of the mesh bag, the first circular hole at the right end of the mesh bag and the second circular hole at the right end of the mesh bag form a containing space for placing the bracket.
4. The vertebral body expansion device for bone filler injection of claim 1, wherein the scaffold is comprised of a flexible structure and a rigid structure, the flexible structure including a first scaffold securing ring and a second scaffold securing ring, the first scaffold securing ring having a smaller diameter than the second scaffold securing ring and having a uniform wire diameter, the rigid structure including a first scaffold support bar, a second scaffold support bar, and a third scaffold support bar hinged in sequence. The articulation of the rigid structure, together with the flexible structure, allows the stent to be deformed. The flexible structure can be made of PET material, and the rigid structure can be made of stainless steel and titanium alloy material.
5. A vertebral body expansion device for bone filler injection according to claim 4, wherein the stent is formed from a series of filaments staggered to form a unitary mesh structure. The filaments are made of memory alloy materials, and the stent can be spread under the influence of temperature; the material of the bracket can be nickel-titanium alloy;
the stent may be a helical structure formed from one filament; the filaments are made of memory alloy materials, and the stent can be spread under the influence of temperature; the material of the bracket can be nickel-titanium alloy;
the bracket consists of a supporting shaft, a rotating shaft assembly, a supporting rod, a supporting plate, a sleeve and a locking structure; the support rod is hinged with the support shaft, the support rod is hinged with the support plate, and the support rod is hinged with the sleeve, and the hinge is realized through the rotating shaft assembly; the centers of the sleeve and the locking structure are provided with round holes which are sleeved on the supporting shaft; when the locking structure moves on the support shaft, the sleeve, the support rod and the support plate also move, so that the support is deformed.
6. The vertebral body expansion device for bone filler injection of claim 1, wherein the outer tube assembly comprises an outer tube and a connector, the outer tube is of a tubular structure, the left end of the outer tube is provided with an outer tube groove for being matched with a boss at the right end of a mesh bag so that the outer tube and the mesh bag can not rotate relatively, the outer tube is further provided with an outer tube first channel, the inner diameter of the outer tube first channel is slightly larger than the outer diameter of the middle sleeve, and the middle sleeve can move in the outer tube first channel; the outer tube can be made of stainless steel.
The inner diameter of the joint first channel is slightly larger than the outer diameter of the outer tube, the joint first channel, the joint second channel and the joint third channel are connected together through bonding, the inner diameter of the joint second channel is slightly larger than the outer diameter of the middle sleeve, the middle sleeve can move and rotate in the sleeve channel, and the middle sleeve assembly can move and rotate through the joint third channel; the joint can be made of PC material.
7. The vertebral body expansion device of claim 6, wherein the connector further comprises a connector boss for mating with the middle cannula assembly, and wherein the connector further comprises a connector handle for facilitating gripping.
8. A vertebral body expansion device for bone filler injection according to claim 1, wherein the middle sleeve assembly includes a middle sleeve for pushing the stent and triggering the stent to expand, and a luer fitting for connecting with the bone filler injector and providing a stop for the middle sleeve assembly.
9. The vertebral body expansion device for bone filler injection of claim 8, wherein the middle sleeve has a tubular structure, a middle sleeve circular hole for providing a conveying channel for the bone filler is arranged in the middle sleeve, a middle sleeve thread is arranged at the middle part of the middle sleeve, the middle sleeve thread is matched with an internal thread arranged on a first circular hole at the right end of the mesh bag, a middle sleeve step is arranged at the left side of the middle sleeve thread, and the middle sleeve step is contacted with the bracket; the middle sleeve in the other form is not provided with threads, but is provided with a middle sleeve boss which is matched with the groove of the locking structure; the middle sleeve can be made of stainless steel materials.
10. The vertebral body expansion device for bone filler injection of claim 8, wherein the luer fitting is provided with a luer fitting first circular hole, a luer fitting bottom surface, a luer fitting thread and a luer fitting second circular hole, the luer fitting first circular hole is bonded and fixed with the middle sleeve, the luer fitting thread is used for being connected with a bone filler injector, and the bone filler injector enables bone filler to enter the inside of the mesh bag along the luer fitting second circular hole and the middle sleeve circular hole respectively; the luer connector can be made of PC material.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211737060.2A CN117281603A (en) | 2022-12-31 | 2022-12-31 | Vertebral body expansion device for bone filler injection and control method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211737060.2A CN117281603A (en) | 2022-12-31 | 2022-12-31 | Vertebral body expansion device for bone filler injection and control method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117281603A true CN117281603A (en) | 2023-12-26 |
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ID=89255916
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202211737060.2A Pending CN117281603A (en) | 2022-12-31 | 2022-12-31 | Vertebral body expansion device for bone filler injection and control method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117281603A (en) |
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2022
- 2022-12-31 CN CN202211737060.2A patent/CN117281603A/en active Pending
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