CN110025371B - Vertebral bone filling support device - Google Patents
Vertebral bone filling support device Download PDFInfo
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- CN110025371B CN110025371B CN201910382736.2A CN201910382736A CN110025371B CN 110025371 B CN110025371 B CN 110025371B CN 201910382736 A CN201910382736 A CN 201910382736A CN 110025371 B CN110025371 B CN 110025371B
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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
- 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
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers, e.g. 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
- 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
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers, e.g. 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
- 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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- Health & Medical Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
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- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Prostheses (AREA)
Abstract
本发明提供了一种椎体骨填充支撑装置，包括：植入件，其包括一中央管部和多个周围突起部，所述的中央管部一端为盲端，另一端为注入口；所述的周围突起部设置在中央管部主体上，且多个周围突起部沿中央管部外壁周向呈发散状分布；周围突起部内腔与中央管部内腔连通；所述中央管部的中心线为直线或弧线；所述的中央管部主体和周围突起部的材质均为软质弹性材料，向中央管部内腔施加压力时，周围突起部能够膨胀伸展形成支撑结构。从而解决了现有产品很难将骨折部位向各个方向均匀撑开进行复位的弊端。本发明使得骨水泥的渗漏率降低为零，减少因骨水泥为团块的灌注出现热损伤所致的骨坏死的发生，并且能最为有效定向恢复上终板塌陷的椎体高度。
The present invention provides a vertebral bone filling support device, comprising: an implant, which includes a central tube and a plurality of peripheral protrusions, wherein one end of the central tube is a blind end and the other end is an injection port; the peripheral protrusions are arranged on the main body of the central tube, and the plurality of peripheral protrusions are distributed in a divergent manner along the circumference of the outer wall of the central tube; the inner cavity of the peripheral protrusions is connected with the inner cavity of the central tube; the center line of the central tube is a straight line or an arc; the main body of the central tube and the peripheral protrusions are made of soft elastic materials, and when pressure is applied to the inner cavity of the central tube, the peripheral protrusions can expand and stretch to form a support structure. Thus, the disadvantage of existing products that it is difficult to evenly expand the fracture site in all directions for reduction is solved. The present invention reduces the leakage rate of bone cement to zero, reduces the occurrence of bone necrosis caused by thermal damage caused by the infusion of bone cement in a mass, and can most effectively restore the height of the vertebral body with collapsed upper end plate.
Description
Technical Field
The invention relates to the technical field of bone cement devices, in particular to a vertebral bone filling and supporting device.
Background
At present, china is in flourishing age of economic development, people are increasingly aged, people attach importance to life quality, and osteoporosis is a global public health problem. Osteoporotic vertebral compression fracture (osteoporotic vertebral compression fractures, OVCF) is one of the most common complications of osteoporosis, and is also an important cause of disability and death in the elderly. For vertebral compression fracture, traditional treatment is still mainly conservative, including lying in bed, relieving pain, wearing chest and waist brace and the like, 84% of patients will leave acute and chronic chest and waist pain, spinal deformity and the like, so that daily life is limited, the function of the spinal column is influenced, and the quality of life is reduced. While the operation treatment is selected, the prior pedicle screw fixation is insufficient in holding force due to osteoporosis of patients, screw loosening and internal fixation failure are extremely easy to occur, although in recent years, most students develop bone cement screws for treating the osteoporosis spine fracture, and bring new hopes to the patients, most patients are forced to abandon the operation treatment of internal fixation due to the fact that the combined internal medicine diseases cannot tolerate anesthesia.
For such patients, local anesthesia downlink Percutaneous Vertebroplasty (PVP) and kyphoplasty (PKP) are the most widely accepted minimally invasive methods of treatment OVCF at present, however, these 2 procedures all have high bone cement leakage rates, which are reported to be 11% -76% and about 4.8% -39.0% respectively. In order to further reduce the leakage rate of bone cement and improve the operation safety, the bone cement is usually injected under low pressure after the expansion of a shaper before being pushed into the bone cement, and the clinical application of the bone cement is approved to be expanded by the indirect action of a hydraulic system in 1994 and reset and compress collapsed vertebral bodies by the aid of the FDA in 1994 according to MARK REILEY invention of Kyphon Balloon kyphoplasty (Balloon-kyphoplasty, BKP) at the earliest, so that the bone cement belongs to soft expansion and is difficult to orient in expansion. In 2004, isc-O-Tech company invents that a polymer material is used to make Sky bone expander kyphosis (Sky-bone expander kyphoplasty, EKP), and the anterior operation of the cylindrical expander is filled with the folded and folded for expansion, which is a rigid expansion and can be oriented, and the disadvantages are that: the position of the expansion height after limited expansion can not be changed, the height can not be adjusted, the expansion shape is mulberry, so the height recovery of the middle part of the vertebral body is slightly higher, and the improvement of the backward convex Cobb angle is poor. The A-Spine company in 2007 invents a novel bone pocket filling cone molding (VESSELPLASTY) technology, and in 2013 formally obtains the certification of the food and drug administration in China and introduces the certification into China. The adopted Vessel-X pouch filler is a mesh bag-shaped structure formed by interweaving high polymer materials, the purpose of expansion can be achieved by directly pouring viscous bone cement, the compact high polymer mesh layer structure can wrap most of bone cement, only a small amount of bone cement is allowed to permeate out of a mesh layer, thus the leakage of the bone cement can be effectively controlled, the leakage rate is still 1.7% -54.5% according to the report of the literature, the bone cement is prevented from being microscopically stranded and locked between the bone cement and the trabecular due to the limit of the outward leakage of the cement of the mesh bag, the loosening of the bone cement clusters of the mesh bag occurs and the bone cement clusters are dissociated outside the vertebral body after the operation and the report of the literature, the bone cement of the mesh bag still exists in the state of the clusters in the vertebral body, the local strength and the polymerization reaction temperature are too high, the polymerization exothermic reaction temperature of the bone cement is researched to be up to 47-100 ℃, the bone cell necrosis is caused by the bone cement polymerization exothermic and the bone cement thickness has a certain relation, and the thicker bone cement is more the heat is released.
Bone cement leakage is one of the most common complications and the most serious complications of minimally invasive treatment of spinal compression fracture, leakage is reduced due to pushing in of a bone cement in a wiredrawing period and a lump period, but uneven dispersion of bone cement occurs, so that mechanical gradient difference is formed locally in a perfusion section after operation, bone cortex of a non-perfusion section and fracture of a vertebral body of an adjacent section are easy to occur again, and bone cement is frequently displaced again when the bone cement forms a lump in the vertebral body. And then toxic reaction, allergy, shock and the like of bone cement.
To date, all the current shaping systems on the market have the problems that the injected bone cement leaks, is unevenly distributed in a cluster shape, is thermally damaged, has toxic reaction and later bone cement shift and the like, and the problems are mainly and urgently needed to be solved in the current spine vertebral body shaping operation.
Disclosure of Invention
The invention aims to provide a vertebral bone filling and supporting device which can completely solve the problems of bone cement leakage and toxic reaction, reduce the displacement of the bone cement, ensure that the grouting slurry is uniformly distributed, reduce the occurrence of bone necrosis caused by thermal injury of the bone cement in the grouting of a lump, and can restore the collapsed vertebral height of an upper end plate most effectively and directionally, and the bone cement forms a good device system similar to the uniform supporting stress of a bone trabecular column.
In order to achieve the above task, the present invention adopts the following technical solutions:
a vertebral bone filling support device comprising:
The implant comprises a central tube part and a plurality of peripheral protruding parts, wherein one end of the central tube part is a blind end, and the other end of the central tube part is an injection port; the peripheral protruding parts are arranged on the central pipe part main body, and the plurality of peripheral protruding parts are distributed in a divergent manner along the circumferential direction of the outer wall of the central pipe part; the inner cavity of the peripheral protrusion part is communicated with the inner cavity of the central tube part;
the main body of the central tube part and the surrounding protruding parts are made of soft elastic materials, and when pressure is applied to the inner cavity of the central tube part, the surrounding protruding parts can expand and stretch to form a supporting structure.
As a further improvement of the invention, when the injection port is filled with the infusion slurry by injection in the central tube portion, the infusion slurry pushes the peripheral protrusion to expand and then to extend into and solidify into the bone tissue.
As a further improvement of the present invention, the central tube portion has a columnar structure, the peripheral protrusion portion has a truncated cone structure, one end of the peripheral protrusion portion is a blind end, the other end is an open end, and the open end is connected to the central tube portion.
As a further improvement of the present invention, the peripheral protrusions are uniformly arranged in a ring shape along the circumferential direction of the central tube portion, and the ring-shaped peripheral protrusions are uniformly arranged along the axial direction of the central tube portion.
As a further development of the invention, adjacent annular circumferential projections are arranged offset.
As a further improvement of the present invention, the center line of the central tube portion is a straight line; the wall thickness of the peripheral protrusion of the central tube portion on the side of the unbroken tissue is greater than the wall thickness of the peripheral protrusion on the side of the fracture void.
As a further improvement of the invention, the central line of the central tube part is an arc line; wherein the peripheral protrusion includes an outer curved portion and an inner curved portion, the peripheral protrusion wall thickness of the outer curved portion being smaller than the peripheral protrusion wall thickness of the inner curved portion.
As a further improvement of the present invention, there is also included:
The auxiliary positioning piece comprises a positioning core part and a clamping part, and the clamping part is arranged at the end part of the positioning core part; the inner wall of the blind end is provided with a clamping groove, after the auxiliary positioning piece stretches into the inner cavity of the central pipe part, the clamping part is in contact with the inner part of the blind end, the core part is rotationally positioned, and the clamping part can be locked and fixed with the clamping groove.
As a further improvement of the present invention, the implant further comprises: and the developing clamping ring is arranged at the front, middle and rear ends of the outer wall of the central pipe part.
As a further improvement of the invention, the inner wall of the injection port is provided with an internal thread.
Compared with the prior art, the invention has the following beneficial effects:
According to the vertebral bone filling and supporting device, the peripheral protruding part of the implant is of a hollow structure, the peripheral protruding part is connected with the inner surface of the central tube part, a plurality of circles of peripheral protruding parts are arranged around the central tube part, the soft elastic materials of the main body of the central tube part and the peripheral protruding parts can expand, and when pressure is applied to the inner cavity of the central tube part, the peripheral protruding parts can expand to form a supporting structure. When the implant is placed into the vertebral body, the implant can be easily placed into the pathological vertebral body through the channel, cement can enter through the peripheral protruding part of the lateral opening, and the peripheral of the central tube is gradually expanded and stretched to form columnar extension of the bone-like trabecula and bone tissue due to the gradual increase of the rear pouring pressure; and then the bone cement is ossified to form a uniform trapezoid columnar support. The divergent peripheral protruding part of the implant solves the leakage occurrence during bone cement pouring, so that the leakage rate of bone cement is reduced to zero; meanwhile, the defect that bone cement injected into the vertebral body by the existing forming system is unevenly distributed in a lump is overcome, the bone-like trabecula is formed to enable the grouting slurry to be evenly distributed, the lower end wall part and the rear end wall part of the bone-like trabecula are thickened to enable the grouting slurry to flow to the front end and the upper end of the peripheral protruding part, and the front middle part of the fractured vertebral body is gradually and evenly collapsed to carry out effective resetting and correction on kyphosis; the existence of local mechanical gradient of the pathological change centrum is reduced through the uniform distribution of bone cement, so that the risks of fracture and high loss of the pathological change centrum after operation and fracture of adjacent segment centrum are greatly reduced. The existing bone cement in the block shape is replaced by the peripheral protruding parts in the divergent shape, so that the thermal damage caused by polymerization reaction when the bone cement block is distributed is solved, and the thermal damage caused by the bone cement block is reduced.
Furthermore, when three metal wires are arranged at the front, middle and rear of the wall part of the central pipeline of the device and are positioned at the front position of the centrum midline through perspective determination, the positioning and instrument tracking observation are facilitated when bone cement is directly poured through the central pipeline part.
Furthermore, the thickness of the trapezoid columnar wall part of the bone trabecula forming part near the lower end and the rear of the vertebral body is 1 time of that of the front end and the upper end, the significance of the design is that when bone cement is injected in a pushing mode, the surrounding protruding parts at the front end and the upper end are easy to expand, the pressure is higher than that of the lower end and the rear, compression fracture of the vertebral body often occurs at the front middle part and collapse of the upper end plate of the vertebral body, the density of bone cortex above and in front of the fractured vertebral body is higher than that of the residual vertebral body, the expansion of the surrounding protruding part forming part is distributed according to the internal pressure of the vertebral body, the trend of expanding is lower than that of the area, the thickening of the lower end wall part and the rear end wall part forces the bone cement to flow to the upper end and the surrounding protruding part which are easy to expand, and the defect that all products on the market are difficult to uniformly expand the fracture part in all directions to perform directional resetting is overcome.
Furthermore, the peripheral protruding parts are distributed in a staggered way to form gaps, so that the remaining bone trabeculae in the vertebral body are settled in the gaps, the vertebral body bone filling and supporting device is stabilized in the vertebral body after fracture healing, and the occurrence of loosening and displacement of bone cement caused by movable extrusion of a patient in the later period is reduced.
Drawings
FIG. 1 is a schematic cross-sectional view of a vertebral bone filling and supporting device of the present invention;
FIG. 2 is a schematic view (straight line) of the spinal bone filler support device of the present invention after expansion;
FIG. 3 is a schematic view of the spinal bone filler support device of the present invention after expansion and extension (flexion);
FIG. 4 is a partial cross-sectional view (curved) of the spinal bone filler support device of the present invention after expansion;
FIG. 5 is a schematic view of the expanded end portion (blind end) of the vertebral bone filling support device of the present invention;
FIG. 6 is a partial cross-sectional view (sized) of the spinal bone filler support device of the present invention after expansion;
FIG. 7 is a view showing the state of the operation of implanting the vertebral bone filling and supporting device of the present invention into a vertebral body;
FIG. 8 is a schematic view of the implantation of the vertebral bone filler support device of the present invention into a vertebral body (single straight line);
FIG. 9 is a schematic view of the insertion of the bone filler support device of the present invention into a vertebral body (two straight lines);
FIG. 10 is a schematic view of the implantation of the vertebral bone filler support device of the present invention into a vertebral body (single curve);
Wherein 100 is an implant, 101 is a peripheral protrusion, 102 is a central tube, 103 is a developing snap ring, 104 is an injection port, 105 is a blind end, and 106 is a clamping groove; 1011 is an outer bend and 1012 is an inner bend; 200 is an auxiliary positioning piece, 201 is a positioning core part, and 202 is a clamping part; 300 is a perfusion slurry, 400 is a vertebral body, 401 is a fracture crack cavity, 402 is unbroken tissue, and 500 is a bone cement pushing device.
Detailed Description
The invention will be described in further detail with reference to the drawings and the specific examples.
As shown in fig. 1 to 6, the present invention provides a vertebral bone filling and supporting device, comprising:
The implant 100 comprises a central tube portion 102 and a plurality of peripheral protrusions 101, wherein one end of the central tube portion 102 is a blind end 105, and the other end is an injection port 104; the peripheral protruding parts 101 are arranged on the main body of the central pipe part 102, and the plurality of peripheral protruding parts 101 are distributed in a divergent manner along the circumferential direction of the outer wall of the central pipe part 102; the inner cavity of the peripheral protrusion part 101 is communicated with the inner cavity of the central tube part 102; the central line of the central pipe part 102 is a straight line or an arc line;
The main body of the central tube 102 and the surrounding protruding parts 101 are made of soft elastic materials, and when pressure is applied to the inner cavity of the central tube 102, the surrounding protruding parts 101 can expand and stretch to form a supporting structure. When the injection port 104 is filled with the casting compound 300 through injection, the casting compound 300 pushes the peripheral protrusion 101 to expand and then to be introduced into the bone tissue, thereby solidifying the bone tissue. The divergent peripheral protruding part of the implant solves the leakage occurrence during bone cement pouring, so that the leakage rate of bone cement is reduced to zero; meanwhile, the defect that bone cement injected into the vertebral body is unevenly distributed in a lump in the existing forming system is overcome, and the surrounding protruding parts 101 are of a bone-like trabecular structure, so that the injection slurry is evenly distributed.
Preferably, the central tube 102 has a columnar structure, the peripheral protrusion 101 has a truncated cone structure, one end of the peripheral protrusion 101 is a blind end, the other end is an open end, and the open end is connected to the central tube 102. Cement diffuses from the bottom to the top of the truncated cone structure, and is convenient for flowing and expanding.
Preferably, the circumferential protrusions 101 are uniformly arranged in a ring shape along the circumferential direction of the central tube portion 102, and the ring-shaped circumferential protrusions are uniformly arranged along the axial direction of the central tube portion 102.
Preferably, adjacent annular circumferential protrusions are arranged offset.
Preferably, the central tube portion 102 has a greater wall thickness at the peripheral protrusion disposed on the unbroken tissue 402 side than at the fracture cavity 401 side. When bone cement is injected, the peripheral protrusions 101 at the front and upper ends are easily inflated, and the pressure is higher than the lower and rear ends. The expansion of the peripheral protrusion 101 tends to be lower than the expansion of the region according to the internal pressure distribution of the vertebral body, and the thickening of the lower end and the rear end wall portion forces bone cement to flow to the upper end and the front end forming portion which are easy to expand for expanding and resetting, thereby solving the defect that the fracture part is difficult to uniformly expand in all directions for resetting in the existing products.
Preferably, the method further comprises:
An auxiliary positioning member 200 including a positioning core 201 and a chucking portion 202, the chucking portion 202 being provided at an end of the positioning core 201; the inner wall of the blind end 105 is provided with a clamping groove 106, after the auxiliary positioning piece 200 stretches into the inner cavity of the central tube part 102, the clamping part 202 contacts with the inside of the blind end 105, the core part 201 is positioned in a rotating mode, and the clamping part 202 can be locked and fixed with the clamping groove 106. After the positioning core 201 is sent to the preset position, the clamping part 202 can be unlocked with the clamping groove 106, and the auxiliary positioning piece 20 is withdrawn.
Preferably, the implant 100 further comprises: and a developing snap ring 103, wherein the developing snap ring 103 is arranged at the front, middle and rear ends of the outer wall of the central pipe part 102. To ensure an optimal location for implantation of the device.
Preferably, the inner wall of the injection port 104 is provided with an internal thread. Is convenient for screw connection with the bone cement pushing device.
Example 1
As shown in fig. 1,2 and 5, a vertebral bone filling support device includes an elastic implant 100 and an auxiliary positioning member 200; the overall outer structure of the central tube portion 102 is a cylindrical hollow structure having a diameter of about 5.0 mm; the peripheral protruding part 101 is of a trapezoid columnar hollow structure (a truncated cone structure), one end of the peripheral protruding part is a blind end, the other end of the peripheral protruding part is opened and connected with the inner surface of the central tube part 102, 10 peripheral protruding parts 101 are arranged around the peripheral ring of the central tube part 102, the total length of 7 rings is about 25cm, when the peripheral protruding part is placed in the hollow crease of the vertebral bone filling and supporting device, the hollow crease is arranged at the inner opening, and a channel which is opened and expanded by an operation can be easily placed in a pathological change vertebral body; the front, middle and rear of the outer wall of the central tube part 102 of the device are provided with developing clamping rings 103 made of three metal wires. When the developing clamp ring 103 is positioned at the front position of the centrum midline through perspective determination, when the grouting material 300 (such as bone cement) is directly infused through the injection port 104 of the central tube part 102, the distal end is a blind end 105, the grouting material 300 can enter the peripheral protruding part 101 with a lateral opening, and 70 peripheral protruding parts 101 around the central tube part 102 are gradually expanded and stretched to form bone-like trabeculae which extend into bone tissues due to the gradual increase of the rear grouting pressure; and then the bone cement is solidified to form a uniform truncated cone-shaped support.
The auxiliary positioning piece 200 comprises a positioning core 201 and a clamping part 202, the clamping part 202 is arranged at the end part of the positioning core 201, a clamping groove 106 is formed in the side wall of the blind end 105, after the auxiliary positioning piece 200 stretches into the inner cavity of the central pipe part 102, the clamping part 202 is in contact with the inside of the blind end 105 of the central pipe part 102, the positioning core 201 is rotated, and the clamping part 202 can be locked and fixed with the clamping groove 106. The implant 100 can be accurately delivered into the diseased vertebral body 400 by the aid of the auxiliary positioning member 200. The main body of the clamping part 202 is a disc structure, and the disc is provided with a buckle matched with the clamping groove 106.
Because compression fracture of the vertebral body tends to occur in collapse of the anterior middle and superior endplates of the vertebral body, resulting in a higher density of cortical bone over and anterior to the fractured vertebral body than the remaining vertebral body, the device has a wall thickness of the surrounding protrusions 101 near the lower and posterior ends of the vertebral body that is 1 time the thickness of the surrounding protrusions 101 at the anterior and superior ends, and the structure is characterized by a tendency for the surrounding protrusions 101 at the anterior and superior ends to expand when bone cement is injected under a higher pressure than at the inferior and posterior ends. According to the expansion of the peripheral protruding part 101 designed by the invention, according to the internal pressure distribution of the vertebral body, the expansion trend is lower than the expansion trend of the area, the thickening of the lower end wall part and the rear end wall part forces bone cement to flow to the upper end and the front end forming part which are easy to expand for expanding and resetting, so that the defect that the fracture part is difficult to uniformly expand in all directions for resetting in the existing product is overcome.
The round table-shaped design makes the formed peripheral protrusion 101 resemble a jack principle, the major diameter of the bottom is 3.5mm, the minor diameter of the top is 1.5mm, and the maximum supporting force is exerted for resetting. Around the central tube 1021, 10 peripheral protrusions 101 are provided so as to be divergently extended, and 7 turns of the central tube have a total length of about 27 mm.
In order to prevent uneven supporting force caused by overlarge distance between the surrounding protruding parts 101 on the adjacent circles, the surrounding protruding parts 101 on the 2 nd circle designed by the invention rotate 15 degrees clockwise relative to the previous circle, fill the gap between the surrounding protruding parts 101 on the 1 st circle, reduce the structural interval span between trabeculae and evenly distribute.
Example 2
As shown in fig. 1,3,4 and 5, the overall structure of the vertebral bone filling and supporting device according to the present invention is the same as that of embodiment 1, except that: the central tube part 102 is in a micro-arc structure after being fully expanded, 70 peripheral protruding parts 101 are arranged in an arc shape along the axial direction of the central tube part 102, and the axial line of the central tube part 102 is parallel to the external coronal surface of the peripheral protruding parts 101.
Wherein the wall thickness of the peripheral protrusions on the outer curved portion 1011 of the arcuate structure is half the wall thickness of the peripheral protrusions of the inner curved portion 1012. The outer curve 1011 is correspondingly disposed at the fracture cavity 401 and the inner curve 1012 is disposed at the unbroken tissue 402.
The casting slurry 300 may be bone cement, PMMA, CPC, or the like.
As shown in fig. 6, the vertebral bone filling and supporting device of the invention can be provided with three types of large, medium and small sizes to adapt to the operation requirements of different objects, and the sizes of the devices are as follows:
A, the total height is 20mm; b, the total length is 27mm; c, the diameter of the central tube is 4.0mm; d, the diameter of the central hollow tube is 2.4mm; e, the diameter of the base of the surrounding protrusion 101 is 3.5mm; f, 1.5mm of blind end of the surrounding protrusion 101; the spacing between the convex side similar first circle of trabecula and the second circle of trabecula is 4.8mm; g, spacing between trabeculae of the concave side bone is 3.0mm; j: the spacing between coaxial trabeculae is 4.9mm.
As shown in fig. 7 to 10, the present invention provides a vertebral bone filling and supporting device, which is used as follows:
1. The channel tube used in the current clinical vertebroplasty can be easily placed into the pathological change of the vertebral body 400, the front, the middle and the rear of the device are respectively provided with a developing clamp ring 103 made of developed titanium alloy so as to ensure the optimal position for implanting the device, and after the projection of the middle clamp ring on the positive position sheet is overlapped or similar to the projection position of the spinous process, the nut at the rear of the rotating channel is withdrawn from the inner core 200 of the central tube part 102.
2. When the bone cement pushing device 500 is matched, the prepared bone cement is pushed and injected through the central tube part 102, when the bone cement passes through the peripheral protruding part 101 of the upper opening of the central tube part 102, the corrugated part of the bone cement is gradually opened and slowly expanded, the principle of expansion is soft materials, the bone cement injection is liquid, the peripheral protruding part 101 encounters hard unbroken tissues 402 and can bypass and avoid to extend to other soft tissues or gaps, namely the fracture crack cavity 401 spreads, the peripheral unbroken bone trabeculae are cut less, and a frustum-shaped structure is formed after expansion;
Fig. 8 and 9 are linear structures of example 1, and one vertebral bone filling support device (fig. 8) or two vertebral bone filling support devices (fig. 9) are placed according to the operation requirement.
Fig. 10 shows a curved configuration of embodiment 2, wherein the curved profile of implant 100 conforms to the arcuate configuration of vertebral body 400.
3. With the pushing injection of the bone cement at the rear, the pressure in the surrounding protruding part 101 is gradually increased, and the pressure is concentrated at the upper part and the front end forming part after the thickening of the capsule wall of the bone trabecular structure at the lower part and the rear part, so that the fractured end plate and the collapsed vertebral cortex support are reset, and the gap between the bone trabecular columns is filled with the residual fractured cancellous bone in the embedded vertebral bone tissue with the trapezoid cylindrical structure which is gradually formed and solidified. The device is fully restricted from movement after fracture healing.
4. Among them, the casting paste 300 such as bone cement (bone cement) may be polymethyl methacrylate (PMMA, poly METHYL METHACRYLATE), hydroxyapatite (HA, hydroxy apatite) or bone substitute (bone substitute) may be used, such as gypsum, calcium phosphate, calcium sulfate series, etc., without limitation;
The invention solves several problems existing clinically, adopts the technical proposal, and has the following advantages and positive effects compared with the prior art:
1. completely solves the problem of leakage during bone cement pouring, so that the leakage rate of bone cement is reduced to zero;
2. the defect that bone cement injected into the vertebral body by all forming systems in the market is unevenly distributed in a lump is overcome, the bone-like trabecula is formed so that the grouting slurry is evenly distributed, the lower end wall part and the rear end wall part are thickened so that the grouting slurry flows to the front end forming part and the upper end forming part of the forming part, and the front middle part of the fractured vertebral body is gradually and evenly collapsed to carry out effective reduction correction on kyphosis;
3. The existence of local mechanical gradient of the pathological change vertebral body is reduced through the uniform distribution of bone cement, and fracture and high loss of the pathological change vertebral body after operation and fracture risk of adjacent segment vertebral bodies are reduced.
4. The bone cement in the block shape is replaced by 70 protrusions 101 with the thickness of 3.5mm around, so that the thermal damage caused by polymerization reaction when the bone cement blocks are distributed is solved, researches show that the thickness of the bone cement influences the temperature of heat release of polymerization, the bone cement is not damaged when the thickness is 5mm, and the heat damage is caused when the thickness exceeds 5 mm;
5. Gaps exist in the staggered distribution of the surrounding protruding parts 101, so that the remaining bone trabeculae in the vertebral body are settled in the gaps, the vertebral body bone filling and supporting device is stabilized in the vertebral body after fracture healing, and the occurrence of loosening and shifting of bone cement caused by movable extrusion of a patient in the later period is reduced;
6. The closed device of the bone-like trabecula completely solves the adverse reactions of bone cement monomer toxicity, allergy, inflammation, embolism and the like which are contacted with human bodies;
7. the device has the characteristic of no leakage, breaks through the contraindication of the use of the incomplete person of all vertebroplasty systems in the current market due to the damage of the back wall of the vertebroplasty, and expands the indication of the product;
The above embodiments are only for illustrating the technical solution of the present invention and not for limiting the same, and although the present invention has been described in detail with reference to the above embodiments, one skilled in the art may make modifications and equivalents to the specific embodiments of the present invention, and any modifications and equivalents not departing from the spirit and scope of the present invention are within the scope of the claims of the present invention.
Claims (5)
1. A vertebral bone filling and supporting device, comprising:
an implant (100) comprising a central tube portion (102) and a plurality of peripheral protrusions (101), said central tube portion (102) having a blind end (105) at one end and an injection port (104) at the other end; the peripheral protruding parts (101) are arranged on the main body of the central pipe part (102), and the plurality of peripheral protruding parts (101) are distributed in a divergent manner along the circumferential direction of the outer wall of the central pipe part (102); the inner cavity of the peripheral protrusion part (101) is communicated with the inner cavity of the central tube part (102);
the main body of the central tube part (102) and the surrounding protruding parts (101) are made of soft elastic materials, and when pressure is applied to the inner cavity of the central tube part (102), the surrounding protruding parts (101) can expand and stretch to form a supporting structure;
The central pipe part (102) is of a columnar structure, the surrounding protruding part (101) is of a round table structure, one end of the surrounding protruding part (101) is a blind end, the other end of the surrounding protruding part is an open end, and the open end is connected with the central pipe part (102);
The peripheral protrusions (101) are uniformly arranged in a ring shape along the circumferential direction of the central tube portion (102), and the ring-shaped peripheral protrusions are uniformly arranged along the axial direction of the central tube portion (102);
adjacent annular surrounding protruding parts are arranged in a staggered way;
the central line of the central pipe part (102) is a straight line; the wall thickness of the peripheral protruding part of the central tube part (102) arranged on the side of the unbroken tissue (402) is larger than that of the peripheral protruding part arranged on the side of the fracture crack cavity (401);
the central line of the central pipe part (102) is an arc line; wherein the peripheral protrusion (101) comprises an outer curved portion (1011) and an inner curved portion (1012), and the peripheral protrusion wall thickness of the outer curved portion (1011) is smaller than the peripheral protrusion wall thickness of the inner curved portion (1012); the thickness of the trapezoid columnar wall part of the bone trabecula forming part near the lower end and the rear of the vertebral body is 1 time of that of the front end and the upper end; the thickening of the lower end wall part and the rear end wall part enables the perfusion slurry to flow to the front end forming part and the upper end forming part of the forming part, and the front middle part of the fractured vertebral body is gradually and uniformly collapsed and columnar supported to effectively reset and correct kyphosis deformity.
2. The vertebral bone filling and supporting device according to claim 1, characterized in that the filling port (104) is filled with a filling slurry (300) by injection in the central tube portion (102), the filling slurry (300) pushing the peripheral protrusion (101) to expand and then to be stretched into and solidified in the bone tissue.
3. The vertebral bone filling support device of any one of claims 1 to 2, further comprising:
An auxiliary positioning member (200) comprising a positioning core (201) and a clamping portion (202), the clamping portion (202) being provided at an end of the positioning core (201); the inner wall of the blind end (105) is provided with a clamping groove (106), after the auxiliary positioning piece (200) stretches into the inner cavity of the central tube part (102), the clamping part (202) is in contact with the inside of the blind end (105), the core part (201) is positioned in a rotating mode, and the clamping part (202) can be locked and fixed with the clamping groove (106).
4. The vertebral bone filling support device according to any one of claims 1 to 2, wherein the implant (100) further comprises: and the developing clamping ring (103) is arranged at the front, middle and rear ends of the outer wall of the central pipe part (102).
5. The vertebral bone filling support device according to any one of claims 1 to 2, wherein the inner wall of the injection port (104) is provided with an internal thread.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910382736.2A CN110025371B (en) | 2019-05-09 | 2019-05-09 | Vertebral bone filling support device |
| PCT/CN2019/106791 WO2020224161A1 (en) | 2019-05-09 | 2019-09-19 | Vertebral-body bone filling and support apparatus |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201910382736.2A CN110025371B (en) | 2019-05-09 | 2019-05-09 | Vertebral bone filling support device |
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| CN110025371A CN110025371A (en) | 2019-07-19 |
| CN110025371B true CN110025371B (en) | 2024-11-12 |
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| CN110025371B (en) * | 2019-05-09 | 2024-11-12 | 郝定均 | Vertebral bone filling support device |
| CN113317911A (en) * | 2021-06-04 | 2021-08-31 | 张丽君 | Pressure expansion type femoral stem |
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| US7220281B2 (en) * | 1999-08-18 | 2007-05-22 | Intrinsic Therapeutics, Inc. | Implant for reinforcing and annulus fibrosis |
| EP1253864B1 (en) * | 2000-01-27 | 2012-10-24 | Kyphon SÀRL | Expanding bone implants |
| WO2009006258A1 (en) * | 2007-07-03 | 2009-01-08 | Spine Tek, Inc. | Interspinous mesh |
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| CN110025371B (en) * | 2019-05-09 | 2024-11-12 | 郝定均 | Vertebral bone filling support device |
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| CN102596069A (en) * | 2009-11-06 | 2012-07-18 | 新特斯有限责任公司 | Minimally invasive interspinous process spacer implants and methods |
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| WO2020224161A1 (en) | 2020-11-12 |
| CN110025371A (en) | 2019-07-19 |
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