CN106618714B - Filling device for injecting bone filling material - Google Patents

Filling device for injecting bone filling material Download PDF

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Publication number
CN106618714B
CN106618714B CN201510736234.7A CN201510736234A CN106618714B CN 106618714 B CN106618714 B CN 106618714B CN 201510736234 A CN201510736234 A CN 201510736234A CN 106618714 B CN106618714 B CN 106618714B
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China
Prior art keywords
mesh bag
pore distribution
pore
balloon
pore size
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CN201510736234.7A
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CN106618714A (en
Inventor
邵卫星
杨文州
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Dragon Crown Medical Co Ltd
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Dragon Crown Medical Co Ltd
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Priority to CN201510736234.7A priority Critical patent/CN106618714B/en
Publication of CN106618714A publication Critical patent/CN106618714A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802Equipment for handling bone cement or other fluid fillers
    • A61B17/8805Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/885Tools for expanding or compacting bones or discs or cavities therein
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties

Abstract

The invention discloses a filling device for injecting bone filling material. The filling device includes an expandable mesh bag having a plurality of pores and a medical grade balloon located inside the mesh bag. The mesh bag used in the filling device for injecting the bone filling material is matched with the balloon for use, the balloon and the mesh bag covering the surface of the balloon are expanded simultaneously in the operation, the balloon is withdrawn after the balloon is expanded to reach the expected height, the mesh bag is reserved in a vertebral body, and the defect that the vertebral body height is lost again in the operation after the balloon is withdrawn in a classic kyphoplasty forming operation can be overcome; and leakage of the bone filling material can be prevented.

Description

Filling device for injecting bone filling material
Technical Field
The invention relates to a vertebroplasty instrument, in particular to a filling device for injecting bone filling material and a using method thereof.
Background
Vertebral body fractures can be caused by trauma, diseases (such as systemic diseases, tumors and the like) and osteoporosis. The severe pain and limited mobility caused by vertebral fracture reduces the quality of life of the patient and may lead to secondary and other pathological changes, even paraplegia and death. The ideal treatment method should rapidly relieve pain caused by fracture, correct kyphosis caused by fracture, and recover the mobility of the patient as soon as possible. There are currently three main treatments: traditional conservative treatment, traditional open surgical treatment and minimally invasive surgical treatment. Compared with other two methods, the minimally invasive surgery treatment method has the advantages of short treatment time, small wound, small pain, less blood loss, short recovery time and short hospitalization time, so the minimally invasive surgery treatment method is gradually widely applied and will become the main treatment method in the future.
Minimally invasive surgical treatments such as Percutaneous Vertebroplasty (PVP) and Percutaneous Kyphoplasty (PKP) are to directly puncture a puncture needle into a fractured vertebral body percutaneously, and then inject bone cement after the fractured vertebral body is dilated by a balloon dilator, so that the height of the fractured vertebral body is restored to a certain degree, the vertebral body is quickly reinforced, and the purposes of relieving pain and recovering activities as soon as possible are achieved. The main problems existing in the existing minimally invasive surgery treatment are that after a balloon expands a collapsed vertebral body, the balloon expander needs to be restored to the original position and pulled out from the vertebral body, and the height of the stretched vertebral body after being pulled out cannot be completely maintained under the elastic creep extrusion of adjacent upper and lower intervertebral discs, so that the cavity is shrunk and the height of the vertebral body is lost again.
Therefore, there is a need for a new filling device for injecting bone filling material to solve the problems of the prior art.
Disclosure of Invention
It is a primary object of the present invention to provide a filling device for injecting bone filler material that includes an expandable mesh bag having a plurality of pores and a medical grade balloon located inside the mesh bag. .
It is also an object of the present invention to provide a method for treating bone abnormalities, comprising:
a) a filling device containing a mesh bag and a balloon is sent into the collapsed vertebral body through a preset working channel,
b) the balloon is pressurized to expand with the mesh bag to form a cavity,
c) the balloon is removed and the mesh bag is left in place,
c) slowly injecting a bone filler material through the injection port of the mesh bag, and
optionally d) closing the mesh bag injection port such that the diameter of the injection port is at least as small as the mesh bag aperture. If the rate of solidification of the bone filler material is sufficiently rapid, step d) may be omitted.
The bone abnormality is selected from: bone tumors, cysts, femoral head necrosis, tibial plateau fractures, spinal compression fractures, vertebral body compression fractures of the lower thoracic and lumbar regions caused by osteoporosis or trauma, and any combination thereof.
The diameter of the injection port of the mesh bag may be about 0.25mm to 10mm, for example 1mm to 5mm, when injecting the bone filling material. The mesh bag injection port can be closed manually (e.g., using a bolt) or automatically.
The mesh bag of the present invention may be of any shape so long as it is capable of supporting a shaft within the shaft, for example it may be oval, circular, rectangular, or other irregular shape within the shaft.
The mesh bag of the present invention may have a pore size of about 0.25 to 6mm, 0.5 to 4mm, or 0.5 to 2mm, and specifically may be 0.25mm, 0.30mm, 0.35mm, 0.40mm, 0.45mm, 0.50mm, 0.55mm, 0.60mm, 0.65mm, 0.70mm, 0.75mm, 0.80mm, 0.85mm, 0.90mm, 0.95mm, 1.00mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.5mm, 3.0mm, 3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm, or 6.0 mm.
In another embodiment, the mesh bag of the present invention may have one or more pore distribution regions with a large pore size and one or more pore distribution regions with a small pore size spaced apart from the pore distribution region with a large pore size such that, in use, the bone filler material in the mesh bag does not substantially leak out of the vertebral body (e.g., vertebral body) from the pore distribution region with a small pore size. In particular, the low density pore distribution region of the mesh bag may be placed in the posterior half of the vertebral body so that the bone filler material does not substantially leak back out of the vertebral body, thereby avoiding serious complications from entering the spinal canal, contacting nerves and dural sac, etc.
The pore distribution region having a small pore diameter of the present invention may also be set to have a smaller pore density than the pore distribution region having a large pore diameter.
The pore distribution area with small pore diameter and the pore distribution area with large pore diameter of the invention can be respectively provided with a plurality of (including 2, 3 or 4), and the number of the pore distribution area with small pore diameter and the pore distribution area with large pore diameter can be the same or different. For example, the pore distribution area with small pore diameter and the pore distribution area with large pore diameter are respectively two, and two pore distribution areas with small pore diameter or two pore distribution areas with large pore diameter are symmetrical relative to the center of the mesh bag or symmetrical relative to a longitudinal axis passing through the center of the mesh bag; of course, in some embodiments, these regions may be asymmetrically distributed, so long as the bone filler material in the mesh bag does not substantially leak out of the vertebral body (e.g., vertebral body) from the small pore size distribution region when in use.
From the cross section of the mesh bag passing through the center of the mesh bag, an included angle is formed between any two points of the cross section and the center of the mesh bag, and the pore distribution area with small pore diameter and the pore distribution area with large pore diameter can also be set according to the degree of the included angle, including but not limited to:
(1)0-90 degrees are pore distribution areas with small pore diameters, and 90-360 degrees are pore distribution areas with large pore diameters;
(2) a pore distribution area with small pore diameter at 0-90 degrees, a pore distribution area with large pore diameter at 90-180 degrees, a pore distribution area with small pore diameter at 180-270 degrees and a pore distribution area with large pore diameter at 270-360 degrees; or
(3) The pore distribution area with small pore diameter is 0-60 degrees, the pore distribution area with large pore diameter is 60-180 degrees, the pore distribution area with small pore diameter is 180-240 degrees, and the pore distribution area with large pore diameter is 240-360 degrees.
The total surface area of the small pore size pore distribution region of the present invention is 10% to 80%, 20% to 50% or 30% to 40% of the surface area of the mesh bag, and specifically may be 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70%, 75% and 80%.
By the arrangement, the pore distribution area with small pore diameter or the pore distribution area with large pore diameter can be distributed in a local specific area, so that the mesh bag can have a directional function when bone materials are filled. In the small pore size pore distribution region of the present invention, the pores have a pore size of less than about 0.25mm, 0.01-0.25mm, 0.05-0.2mm, or 0.1-0.15mm, and specifically may be 0.01mm, 0.02mm, 0.03mm, 0.04mm, 0.05mm, 0.06mm, 0.07mm, 0.08mm, 0.09mm, 0.1mm, 0.11mm, 0.12mm, 0.13mm, 0.14mm, 0.15mm, 0.16mm, 0.17mm, 0.18mm, 0.19mm, or 0.2 mm.
In the pore distribution region having a large pore diameter of the present invention, the pore diameter of the pores is about 0.25 to 6mm, 0.5 to 4mm, or 0.5 to 2mm, and specifically may be 0.25mm, 0.30mm, 0.35mm, 0.40mm, 0.45mm, 0.50mm, 0.55mm, 0.60mm, 0.65mm, 0.70mm, 0.75mm, 0.80mm, 0.85mm, 0.90mm, 0.95mm, 1.00mm, 1.1mm, 1.2mm, 1.3mm, 1.4mm, 1.5mm, 1.6mm, 1.7mm, 1.8mm, 1.9mm, 2.0mm, 2.5mm, 3.0mm, 3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm, or 6.0 mm.
The pore distribution region having a small pore diameter of the present invention can be produced by the following method: (1) when the mesh bag is manufactured, the pore diameter of the pore is directly configured to the required pore size; or (2) covering a large pore size distribution area with the medical coating and removing part of the coating covering the pores to obtain the small pore size distribution area.
The coating material is PET, silica gel, sodium alginate or any combination thereof. Preferably a PET material.
The coating can seal the mesh bag to a certain extent, and the coating distribution area on the mesh bag can be arranged at the back half part of the vertebral body, so that the bone filling material basically cannot leak backwards to the outside of the vertebral body, and serious complications caused by entering a vertebral canal, contacting nerves, a dura mater sac and the like are avoided.
Has the advantages that: the mesh bag used in the filling device for injecting the bone filling material is matched with the balloon for use, the balloon and the mesh bag covered on the surface of the balloon are expanded simultaneously in the operation, the balloon is withdrawn after the balloon is expanded to reach the expected height, the mesh bag is kept in the vertebral body, the defect that the vertebral body height is lost again in the operation after the balloon is withdrawn in the classic kyphoplasty forming operation can be overcome, and the bone filling material can be prevented from leaking.
Drawings
Fig. 1 shows a filling device for injecting bone filler material according to an embodiment of the present invention.
Fig. 2 shows a filling device for injecting bone filler material according to another embodiment of the present invention.
Fig. 3 shows a filling device for injecting bone filler material according to yet another embodiment of the present invention.
Detailed Description
The following description of the embodiments refers to the accompanying drawings for illustrating the specific embodiments in which the invention may be practiced. Furthermore, directional phrases used herein, such as, for example, upper, lower, top, bottom, front, rear, left, right, inner, outer, lateral, peripheral, central, horizontal, lateral, vertical, longitudinal, axial, radial, uppermost or lowermost, etc., refer only to the orientation of the attached drawings. Accordingly, the directional terms used are used for explanation and understanding of the present invention, and are not used for limiting the present invention.
Referring to fig. 1, an embodiment of the present invention provides a filling device 10 for injecting bone filling material, comprising: an inflatable mesh bag 12 having a plurality of apertures; wherein the mesh bag has a pore distribution area 122 with a large pore diameter 112 and a pore distribution area 121 with a small pore diameter 111, so that when in use, the bone filling material in the mesh bag 12 can not substantially leak out of the bone body (such as vertebral body) from the pore distribution area 121 with the small pore diameter.
Wherein the pore distribution area 121 with small pore diameter accounts for 30-40% of the surface area of the mesh bag. When the mesh bag is used, the pore distribution area with low density on the mesh bag can be arranged at the back half part of a vertebral body, so that the bone filling material basically cannot leak backwards to the outside of the vertebral body, and serious complications caused by entering a vertebral canal and contacting nerves, a dura mater sac and the like are avoided. The material of mesh bag 12 should be a biocompatible material including, but not limited to, shape memory alloys, titanium, stainless steel, polymers, metal alloys, ceramics, fabrics, or any combination thereof. The biocompatible material is preferably polyethylene terephthalate.
Referring to fig. 2, another embodiment of the present invention provides a filling device 20 for injecting bone filler material, which further comprises a medical grade balloon 13 located inside the mesh bag 12, in addition to the expandable mesh bag 12 described above. The balloon 13 is constructed at least in part from a material selected from the group consisting of: rubber, nylon, thermoplastic elastomers, polyurethane, and any combination thereof. The mesh bag used in the filling device for injecting the bone filling material is matched with the balloon for use, the balloon and the mesh bag covered on the surface of the balloon are expanded simultaneously in the operation, the balloon is withdrawn after the balloon is expanded to reach the expected height, the mesh bag is kept in the vertebral body, and the defect that the vertebral body height is lost again in the operation after the balloon is withdrawn in the classic kyphoplasty operation can be overcome.
Referring to fig. 3, yet another embodiment of the present invention provides a filling device for injecting bone filler material. The device differs from the device of fig. 1 in that there are two (1211, 1212) small pore distribution areas and two (1221, not shown in the other figure) large pore distribution areas, and that the two small pore distribution areas or the two large pore distribution areas are symmetrical with respect to the center of the mesh bag or with respect to a longitudinal axis through the center of the mesh bag.
The present invention has been described in relation to the above embodiments, which are only exemplary of the implementation of the present invention. It must be noted that the disclosed embodiments do not limit the scope of the invention. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

Claims (5)

1. A filling device for injecting bone filling material, characterized by: the fill device comprises:
an expandable mesh bag having a plurality of pores, wherein the mesh bag is divided into a large pore size pore distribution region and a small pore size pore distribution region, and in use, the bone filler material within the mesh bag does not substantially leak out of the bone from the small pore size pore distribution region, wherein the pores in the small pore size pore distribution region have a pore size of 0.01mm to 0.09mm, wherein the pores in the large pore size pore distribution region have a pore size of 0.70mm to 6.0mm, wherein the small pore size pore distribution region is obtained by: covering a pore distribution area with large pore diameter with a medical coating and removing part of the coating covering the pores to obtain the pore distribution area with small pore diameter; and
a medical grade balloon located inside the mesh bag.
2. The fill device of claim 1, wherein: the total surface area of the pore distribution area with small pore diameter accounts for 10% -80%, 20% -50% or 30% -40% of the surface area of the mesh bag.
3. The fill device of claim 1, wherein: the coating is made of a biocompatible material meeting the implantation requirement, and optionally, the biocompatible material is polyethylene terephthalate (PET), silica gel, sodium alginate or any combination thereof.
4. The fill device of claim 1, wherein: the mesh bag is made of a biocompatible material meeting the implantation requirement; optionally, the biocompatible material is a shape memory alloy, titanium, stainless steel, a polymer, a metal alloy, a ceramic, a fabric, or any combination thereof; optionally, the polymer is polyethylene terephthalate.
5. The fill device of claim 1, wherein: the balloon is constructed at least in part from a material selected from the group consisting of: rubber, nylon, thermoplastic elastomers, polyurethane, and any combination thereof.
CN201510736234.7A 2015-11-02 2015-11-02 Filling device for injecting bone filling material Active CN106618714B (en)

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Families Citing this family (2)

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Publication number Priority date Publication date Assignee Title
CN110141760B (en) * 2019-06-05 2021-10-08 山东百多安医疗器械股份有限公司 Centrum forming expansion balloon with drug loaded on surface and preparation method thereof
CN115068689B (en) * 2022-06-17 2024-01-19 北京邦塞科技有限公司 Bone filling bag, and preparation method and application thereof

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