CN111513890B - Nucleus pulposus prosthesis device implanted into annulus fibrosus of intervertebral disc, manufacturing method thereof and filling device - Google Patents
Nucleus pulposus prosthesis device implanted into annulus fibrosus of intervertebral disc, manufacturing method thereof and filling device Download PDFInfo
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- CN111513890B CN111513890B CN202010332403.1A CN202010332403A CN111513890B CN 111513890 B CN111513890 B CN 111513890B CN 202010332403 A CN202010332403 A CN 202010332403A CN 111513890 B CN111513890 B CN 111513890B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30108—Shapes
- A61F2002/30199—Three-dimensional shapes
- A61F2002/30242—Three-dimensional shapes spherical
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/3094—Designing or manufacturing processes
- A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
- A61F2002/30962—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using stereolithography
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/442—Intervertebral or spinal discs, e.g. resilient
- A61F2002/444—Intervertebral or spinal discs, e.g. resilient for replacing the nucleus pulposus
Abstract
The invention relates to the field of nucleus pulposus prosthesis of intervertebral disc annulus fibrosus, in particular to a nucleus pulposus prosthesis device implanted into the intervertebral disc annulus fibrosus, a manufacturing method thereof and a filling device thereof. A nucleus prosthetic device for implantation into an annulus fibrosus of an intervertebral disc comprising: a balloon shell implantable in the annulus fibrosus of the intervertebral disc, having a filling cavity therein; a filler disposed in the filler lumen to expand the balloon housing; and the sensor is at least provided with one sensor and is arranged on the balloon shell or in the filler. According to the invention, the balloon shell is placed in the annulus fibrosus of the intervertebral disc, and after the balloon shell is inflated, the balloon shell is propped against the inner wall of the annulus fibrosus to form a similar nucleus pulposus structure, so that the replacement of nucleus pulposus is realized, and the inductor is embedded, so that the biological parameters and/or mechanical parameters of the nucleus pulposus prosthesis device in the annulus fibrosus are acquired, the comprehensive monitoring is performed, and the pertinence of the balloon shell is improved.
Description
Technical Field
The invention relates to the field of nucleus pulposus prosthesis of intervertebral disc annulus fibrosus, in particular to a nucleus pulposus prosthesis device implanted into the intervertebral disc annulus fibrosus, a manufacturing method thereof and a filling device thereof.
Background
The cartilage junction between the vertebral bodies of two adjacent vertebrae of an intervertebral disc (intervertebral disc) is called an intervertebral disc, consisting of a peripheral annulus fibrosus and a central nucleus pulposus. The fibrous ring consists of multiple layers of staggered fibrous cartilage rings, firmly connects the vertebral bodies together, has high elasticity and toughness, and can prevent the overflow of the nucleus pulposus besides bearing pressure. The nucleus pulposus is a white gelatinous substance and is rich in elasticity. When the nucleus pulposus is subjected to gravity, it expands circumferentially and presses the annulus fibrosus to extend and expand circumferentially.
In specific situations, such as age factors, bad body positions, occupational factors and factors of cold and dampness and pathological changes, the annulus is torn or damaged, the nucleus pulposus protrudes or gradually reduces the water in the nucleus pulposus to run off, and further, the water content is an important index of the health state of the nucleus pulposus, the nucleus pulposus lacks water or other causes to cause problems, so that the health of human bodies, such as back pain, even intervertebral discs are damaged.
To solve the above problems, a replacement surgery by minimally invasive surgery means at the same location (IN the annulus) can be performed by manufacturing a nucleus prosthesis IN the annulus to replace the nucleus, as described IN U.S. patent applications 8,182,487, 8,728,161, 8,777,951, 9,192,485, 9,216,092, 9,433,512, 9,492,291 and 9,662,227, and korean patent application KR10-1464983-0000 and indian patent application IN3701/DELN/2010, each provide a filling system of filler, and filling the balloon to expand to replace the nucleus.
However, the above-described filling system has the following drawbacks: 1. the corresponding mechanical properties are difficult to obtain, only single filling can be carried out, and because the fine structure of each fiber ring is different, the comprehensive copying is difficult, and particularly, some matching which does not accord with kinematics is a huge test on the nucleus prosthesis; 2. secondly, the nucleus pulposus prosthesis needs to be implanted deep into a human body, is difficult to comprehensively monitor, particularly obtains biological information in the annulus fibrosus, and can only perform operation and later maintenance by fully relying on the experience of doctors.
Disclosure of Invention
The invention aims to solve the technical problems of the prior art, and provides a nucleus pulposus prosthesis device implanted into an intervertebral disc annulus fibrosus, a manufacturing method thereof and a filling device, which solve the problems that a filling system is difficult to obtain corresponding mechanical properties and difficult to comprehensively monitor.
The technical scheme adopted for solving the technical problems is as follows: there is provided a nucleus prosthesis device implanted into an annulus fibrosus of an intervertebral disc, comprising:
a balloon shell implantable in the annulus fibrosus of the intervertebral disc, having a filling cavity therein;
a filler disposed in the filler lumen to expand the balloon housing;
the sensor is at least provided with one sensor, and is arranged on the balloon shell or in the filler; wherein, the liquid crystal display device comprises a liquid crystal display device,
the sensor acquires biological and/or mechanical parameters of the nucleus pulposus prosthetic device within the annulus fibrosus of the intervertebral disc.
Among them, the preferred scheme is: the balloon catheter also comprises a fixed band wire anchor connected with the balloon shell, wherein the fixed band wire anchor comprises at least two wire bodies which extend outwards from the balloon shell, and an anchor head arranged at the end part of the wire bodies.
Among them, the preferred scheme is: the inductor is embedded in the inner wall of the balloon shell.
Among them, the preferred scheme is: the sensor comprises a biological parameter sensor and a mechanical parameter sensor, wherein the biological parameter sensor is one of a PH value sensor, a nitrous oxide sensor, a nitrate sensor, a nitrite sensor and a temperature sensor; the mechanical parameter sensor is one of a pressure sensor, a displacement sensor, an angle sensor or an acceleration sensor.
Among them, the preferred scheme is: the filler is made of silicone resin or medical polyurethane.
The technical scheme adopted for solving the technical problems is as follows: the filling device is used for filling a balloon shell of the nucleus pulposus prosthesis device and comprises a filling gun, a filling material storage bin and a driving module, wherein non-solid filling materials are stored in the filling material storage bin, the filling gun can be inserted into a filling cavity of the balloon shell or a cavity opening close to the filling cavity, and the driving module drives the filling materials to be injected into the filling cavity of the balloon shell through the filling gun; wherein, the liquid crystal display device comprises a liquid crystal display device,
the filler comprises an inductor in the filler storage bin and is injected into the filling cavity of the balloon shell together with the filler; or alternatively, the process may be performed,
the filling device also comprises an inductor embedding port communicated with the filling gun, and the inductor is embedded into the filler in the process that the filler passes through the filling gun; or alternatively, the process may be performed,
the filling gun comprises a filling channel and an inductor embedding channel, the driving module drives the filler to be injected into the filling cavity of the balloon shell through the filling channel of the filling gun, and the inductor embedding channel injects the inductor into the filling cavity of the balloon shell.
The filling gun further comprises a plurality of functional channels, wherein the functional channels are one of a filling channel, a curing lamp setting channel, an inductor embedding channel, a detector setting channel, an image acquisition channel, an auxiliary object adding channel and a filler absorbing and retreating channel.
Preferably, the balloon further comprises at least one reactant storage bin communicated with the filler storage bin or the filling gun, wherein the reactant storage bin stores an auxiliary substance which can react with the filler chemically, and the auxiliary substance is added into the filler in the process of injecting the filler into the filling cavity of the balloon shell.
The technical scheme adopted for solving the technical problems is as follows: there is provided a method of manufacturing a nucleus prosthetic device for implantation into an annulus fibrosus of an intervertebral disc, comprising the steps of:
implanting a balloon shell into the annulus fibrosus of the intervertebral disc, the balloon shell having a filling cavity therein;
injecting a non-solid filler into the filling cavity of the balloon housing and curing within the filling cavity to expand the balloon housing;
and, embedding an inductor into the filler during the filler injection process; alternatively, the inductor is embedded into the filler before the filler is injected; or an inductor is arranged in the balloon shell;
wherein the sensor acquires a biological and/or mechanical parameter of the nucleus pulposus prosthetic device within the annulus fibrosus of the intervertebral disc.
Wherein, the preferred scheme further comprises the steps of:
installing the fixed band wire anchors on the balloon shell, and fixing the fixed band wire anchors on the disc annulus through anchor heads of at least two fixed band wire anchors so as to suture the wound;
alternatively, the balloon shell has mounted thereon a fixed band wire anchor and is secured to the annulus of the disc by anchor heads of at least two fixed band wire anchors to suture the wound.
Compared with the prior art, the invention has the beneficial effects that the balloon shell is placed in the annulus fibrosus of the intervertebral disc, and the balloon shell is propped against the inner wall of the annulus fibrosus after being inflated to form a similar nucleus pulposus structure, so that the replacement of nucleus pulposus is realized, and the inductor is embedded to acquire the biological parameters and/or mechanical parameters of the nucleus pulposus prosthesis device in the annulus fibrosus, so that the comprehensive monitoring is performed, and the pertinence of the balloon shell is improved; and the method is convenient for comprehensively monitoring various biological data, preventing accidents or lesions, or timely and deeply acquiring corresponding biological information under the conditions of the accidents or lesions, quickly and effectively making related solutions, improving comprehensive assurance and effective logistic service for patients, improving the adaptability of the nucleus pulposus prosthesis device in the annulus fibrosus, and improving the success rate and quality of the operation.
Drawings
The invention will be further described with reference to the accompanying drawings and examples, in which:
FIG. 1 is a schematic view of the structure of a nucleus pulposus prosthetic device of the invention implanted in the annulus fibrosus of an intervertebral disc;
FIG. 2 is a schematic view of the structure of the fixed band wire anchor of the present invention;
FIG. 3 is a schematic view showing the construction of the fixing band line anchor of the present invention in its use state;
FIG. 4 is a schematic view of the structure of the filling device of the present invention;
FIG. 5 is a schematic view of a filling device with an inductor insertion opening according to the present invention;
fig. 6 is a flow chart of a method of manufacturing a nucleus prosthesis device of the present invention.
Detailed Description
Preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings.
As shown in FIG. 1, the present invention provides a preferred embodiment of a nucleus prosthetic device for implantation into an annulus fibrosis 120 of an intervertebral disc.
A nucleus pulposus prosthetic device implanted in the annulus fibrosus 120 of an intervertebral disc, comprising a balloon housing 210, a filler 220 and a sensor 230, the balloon housing 210 being implantable in the annulus fibrosus 120 of an intervertebral disc and having a filling cavity therein, the filler 220 being disposed in the filling cavity to expand the balloon housing 210, the sensor 230 being provided with at least one and being disposed on the balloon housing 210 or within the filler 220; wherein the sensor 230 acquires biological and/or mechanical parameters of the nucleus prosthetic device within the annulus 120.
Specifically, in the annulus 120 of the disc, the balloon shell 210 is placed through a minimally invasive surgical aperture, preferably the balloon shell 210 abuts the inner wall of the annulus 120 after inflation to form a nucleus-like structure to effect nucleus replacement. After placement into the balloon shell 210, the filling lumen is filled with a filler 220 by associated equipment and the balloon shell 210 is inflated after the filler 220 has cured to form an alternative structure to the nucleus pulposus. In order to solve the problems that the existing filling system is difficult to obtain corresponding mechanical properties and difficult to fully monitor, in the nucleus pulposus prosthetic device in the annulus fibrosus 120, the sensor 230 is preferably embedded in different positions of the nucleus pulposus prosthetic device, such as the outer side surface of the balloon shell 210, the inner wall of the balloon shell 210, the shell of the balloon shell 210 and the filler 220, so as to obtain biological parameters and/or mechanical parameters of the nucleus pulposus prosthetic device in the annulus fibrosus 120, so as to obtain specific state information of the nucleus pulposus prosthetic device in the annulus fibrosus 120 during the process of forming the nucleus pulposus prosthetic device and after forming the nucleus pulposus prosthetic device, to fully monitor the mechanical relationship, such as pressure and motion state, of the outer side of the balloon shell 210 and the inner wall of the annulus fibrosus 120, and to improve the balloon shell 210 specifically and uniquely, such as external contour improvement and elasticity improvement of various positions.
And, can also obtain the biological information of the fibrous ring 120 or the prosthetic device of nucleus pulposus itself through the inductor 230, be convenient for carry on the comprehensive control to various biological data, prevent the unexpected or pathological change from happening, or can in time, go deep to obtain the corresponding biological information under the unexpected or pathological condition, formulate the relevant solution fast and effectively, promote comprehensive assurance and effective logistic service for the patient, improve the adaptability of prosthetic device of nucleus pulposus in fibrous ring 120 at the same time, improve success rate and quality of the operation.
Wherein the cartilage 110 between the vertebral bodies of two adjacent vertebrae of the intervertebral disc is called intervertebral disc, the peripheral annulus 120 wraps the inner nucleus pulposus, and the nucleus pulposus prosthetic device is adopted to replace the original nucleus pulposus.
In this embodiment, the positioning of the sensor 230 provides two solutions.
In the first embodiment, the inductor 230 is first disposed on the balloon housing 210, preferably embedded in the inner wall of the balloon housing 210, and the inductor 230 is implanted in the balloon housing 210 together with the implantation of the disc annulus 120, and the inductor 230 may be embedded in the balloon housing 210, or the inductor 230 may be embedded in a corresponding position of the balloon housing 210 after the implantation of the balloon housing 210.
Of course, the sensor 230 may be embedded outside the balloon housing 210, or embedded in the housing of the balloon housing 210.
The second embodiment, the sensor 230 is disposed in the filling cavity of the balloon housing 210 and disposed in the filler 220, preferably, the sensor 230 may be embedded on the filler 220 when the filler 220 is implanted in the filling cavity of the balloon housing 210, or the sensor 230 may be implanted in the filling cavity of the balloon housing 210 along with the filler 220.
Wherein the sensor 230 comprises a biological parameter sensor and a mechanical parameter sensor, and the biological parameter sensor is one of a PH sensor, a nitrous oxide sensor, a nitrate sensor, a nitrite sensor and a temperature sensor; the mechanical parameter sensor is one of a pressure sensor, a displacement sensor, an angle sensor or an acceleration sensor. For example, by providing a desired type of bio-parameter sensor, the condition within the annulus 120 of the disc, particularly the physiological condition after implantation of the nucleus prosthesis device, is achieved, facilitating the medical staff to obtain the desired information in a comprehensive and deep manner, and to monitor the disc in a timely and efficient manner. For another example, by setting a mechanical parameter sensor, the degree of matching between the disc annulus 120 and the nucleus pulposus prosthetic device is effectively obtained, and the stability and adaptability of the device are improved, and in particular, the relative pressure between the balloon shell 210 and the disc annulus 120 can be obtained by detecting the acting force condition of the two, so that better and more comprehensive monitoring can be performed.
And, the sensor 230 may be a wired transmission signal or a wireless transmission signal, and through establishing a corresponding wired connection circuit or a wireless transmission module, corresponding signal transmission is performed, so as to meet the requirements of different situations.
In this embodiment, the material of the filler 220 is silicone or medical polyurethane. And, the manner of curing the filler 220 is achieved by platinum catalyzed reaction, the material of the balloon housing 210 is preferably silicone, and the specific structure resembles a sphere.
As shown in fig. 2 and 3, the present invention provides a preferred embodiment of a fixed band wire anchor 230.
The nucleus prosthetic device further includes a fixed band wire anchor 230 coupled to the balloon shell 210, the fixed band wire anchor 230 including at least two wires extending outwardly from the balloon shell 210 and an anchor head disposed at an end of the wires.
Specifically, the balloon shell 210 extends out of the wire body, and is embedded into the corresponding position of the disc annulus 120 through the anchor head on the wire body, especially the surgical opening of the disc annulus 120, for suturing the surgical opening of the disc annulus 120, so as to facilitate subsequent healing. Preferably, two outwardly extending wire bodies are connected inside the balloon housing 210, the two anchor heads are respectively embedded into two ends of the straight line, one anchor head is used for fixing the fixed belt wire anchor 230, the other anchor head is used for suturing the surgical opening, and the suture capability of the anchor heads is improved.
As shown in FIG. 4, the present invention provides a preferred embodiment of the filling device.
The filling device is used for filling the balloon shell 210 of the nucleus pulposus prosthesis device, the filling device comprises a filling gun 320, a filler storage bin 310 and a driving module, the filler storage bin 310 stores non-solid filler 220, the filling gun 320 can be inserted into a filling cavity of the balloon shell 210 or a cavity opening close to the filling cavity, and the driving module drives the filler 220 to be injected into the filling cavity of the balloon shell 210 through the filling gun 320.
As described above, after the balloon housing 210 is placed, the filler 220 is filled into the filling cavity by the related apparatus, and after the filler 220 is cured, the balloon housing 210 is inflated to form an alternative structure of the nucleus, in such a manner that the filling gun 320 of the filling device is inserted into the filling cavity of the balloon housing 210 or near the opening of the filling cavity after the balloon housing 210 is placed, and the non-solid filler 220 in the filler storage bin 310 is implanted into the filling cavity through the filling gun 320 under the driving of the driving module, and is cured after forming a specific shape, as the filling core of the balloon housing 210, the balloon housing 210 is inflated. Meanwhile, in order to cooperate with the inductor 230, the above-described multiple sets of schemes are provided.
In one embodiment, the filler 220 includes a sensor 230 within the filler storage bin 310 and is injected into the filling cavity of the balloon housing 210 with the filler 220. In the filler storage compartment 310, a non-solid filler 220, a liquid filler 220, or a fluid filler 220 is stored, and the corresponding sensor 230 is placed in the filler 220, so that the sensor 230 is injected into the filling cavity of the balloon housing 210 together with the filler 220 when implanted, and the sensor 230 is disposed inside the balloon housing 210.
In a second embodiment, and referring to fig. 5, the filling device further includes a sensor insertion port 330 in communication with the filling gun 320, for inserting the sensor 230 into the filler 220 during the process of passing the filler 220 through the filling gun 320. In the process that the filler 220 passes through the filling gun 320, an inductor embedding opening 330 can be formed in an output port of the filler storage bin 310, and an inductor embedding opening 330 can be formed in an intermediate transmission structure between the filler storage bin 310 and the filling gun 320, so that the inductor 230 is embedded into the filler 220 and is injected into a filling cavity of the balloon shell 210 along with the filler 220, and the inductor 230 is arranged inside the balloon shell 210.
In a third aspect, the filling gun 320 includes a filling channel and an inductor 230 embedding channel, the driving module drives the filler 220 to be injected into the filling cavity of the balloon housing 210 through the filling channel of the filling gun 320, and the inductor 230 embedding channel injects the inductor 230 into the filling cavity of the balloon housing 210. Alternatively, the filler 220 may be injected into the filling cavity of the balloon housing 210 through the filling channel of the filling gun 320, and the sensor 230 may be implanted at a specific time by embedding the sensor 230 into the channel instrument, and attached to the filler 220; alternatively, the filler 220 is injected into the filling cavity of the balloon housing 210 through the filling channel of the filling gun 320, and is divided into a plurality of filling segments, each filling segment is stopped, and the inductor 230 is injected into the filler 220 through the embedding channel of the inductor 230, and then the next filling segment is performed.
Wherein the fill channel and the sensor 230 are embedded in the channel in close or proximate arrangement with the channel openings of the two channels being coplanar or facing in unison. I.e. the filling channel and the channel opening of the insertion channel of the sensor 230 are simultaneously inserted into the filling cavity of the balloon housing 210 when the filling gun 320 is inserted into the filling cavity of the balloon housing 210.
In this embodiment, the filling gun 320 further includes a plurality of functional channels, and the functional channels are one of a filling channel, a curing light setting channel, an inductor embedding channel, a detector setting channel, an image capturing channel, an auxiliary substance adding channel, and a filler absorbing and retracting channel.
Wherein the filling channel communicates with the filler storage bin 310 for transporting the filler 220; a curing lamp is provided at a port of the curing lamp-provided passage to cure the filler 220; the sensor embedding channel is communicated with the sensor storage bin or directly connected with the sensor input port for implanting the sensor 230; a detector, such as an ultrasonic detector, an infrared detector, etc., is provided at the port of the detector-provided channel to assist in the use of the filling gun 320; a camera is arranged at the port of the image acquisition channel to acquire image information or video information so as to assist the use of the filling gun 320; the auxiliary object adding channel is connected with the corresponding auxiliary object storage bin, adds the corresponding auxiliary object into the filler 220, and generates chemical reaction with the filler 220 to realize corresponding change, such as solidification; the filler absorption back channel is to absorb back part of the filler 220, and make layout modification of the filler 220.
In this embodiment, the filling device further comprises at least one reactant reservoir in communication with the filler reservoir 310 or the filling gun 320, the reactant reservoir storing an adjunct capable of chemically reacting with the filler 220 and being added to the filler 220 during injection of the filler 220 into the filling lumen of the balloon housing 210.
In this embodiment, the driving module may be a compression cylinder for compressing the filler 220 and outputting the compressed filler from the filler gun 320.
As shown in FIG. 6, the present invention provides a preferred embodiment of a method of manufacturing a nucleus prosthetic device.
A method of manufacturing a nucleus prosthetic device for implantation into an annulus fibrosis 120 of an intervertebral disc, comprising the steps of:
step S10, implanting a balloon shell 210 into the disc annulus 120, wherein a filling cavity is formed in the balloon shell 210;
step S20, injecting a non-solid filler 220 into the filling cavity of the balloon housing 210, and curing the non-solid filler in the filling cavity to expand the balloon housing 210;
step S31, embedding the sensor 230 into the filler 220 during the injection process of the filler 220;
step S32, embedding the sensor 230 into the filler 220 before injecting the filler 220; alternatively, the balloon housing 210 has an inductor 230 disposed therein;
step S33, the sensor 230 obtains biological and/or mechanical parameters of the nucleus pulposus prosthetic device within the annulus fibrosus 120.
Wherein, after step S20 is completed, any one of steps S31 to S33 may be performed, depending on the specific structure of the nucleus prosthesis device or the specific structure of the filling device.
In this embodiment, the method of manufacturing a nucleus prosthetic device further comprises the steps of:
step S41, installing the fixed band wire anchors 230 on the balloon shell 210, and fixing the fixed band wire anchors 230 on the disc annulus 120 through anchor heads of at least two fixed band wire anchors 230 to suture the wound;
step S42, the balloon shell 210 has the anchor wires 230 mounted thereon, and is fixed to the disc annulus 120 by the anchor heads of at least two anchor wires 230 to suture the wound.
Wherein two sets of schemes are provided through step S41 and step S42, depending on the different configurations of the fixed band wire anchors 230 and the balloon housing 210.
In particular, the above steps are specific to the specific manufacturing process of the nucleus prosthesis device, and are not described in detail herein. Meanwhile, the above steps also relate to a specific use mode of the filling device, and the above steps have been specifically described, and are not described herein.
The foregoing description of the preferred embodiments of the present invention is not intended to limit the scope of the invention, but rather is intended to cover all modifications and variations within the scope of the present invention as defined in the appended claims.
Claims (7)
1. A nucleus pulposus prosthetic device implanted in the annulus fibrosus of an intervertebral disc comprising:
a balloon shell implantable in the annulus fibrosus of the intervertebral disc, having a filling cavity therein;
a filler disposed in the filler lumen to expand the balloon housing;
the fixed belt wire anchor comprises at least two wire bodies and anchor heads, wherein the wire bodies are connected with the balloon shell and extend outwards, the anchor heads are arranged at the end parts of the wire bodies, the anchor heads on one wire body are used for fixing, and the anchor heads on the other wire body are used for suturing a wound;
the sensor is at least provided with one sensor, and is arranged on the balloon shell or in the filler; wherein, the liquid crystal display device comprises a liquid crystal display device,
the sensor acquires biological and/or mechanical parameters of the nucleus pulposus prosthetic device within the annulus fibrosus of the intervertebral disc.
2. The nucleus prosthetic device of claim 1, wherein: the inductor is embedded in the inner wall of the balloon shell.
3. The nucleus prosthetic device of claim 1 or 2, wherein: the sensor comprises a biological parameter sensor and a mechanical parameter sensor, wherein the biological parameter sensor is one of a PH value sensor, a nitrous oxide sensor, a nitrate sensor, a nitrite sensor and a temperature sensor; the mechanical parameter sensor is one of a pressure sensor, a displacement sensor, an angle sensor or an acceleration sensor.
4. The nucleus prosthetic device of claim 1, wherein: the filler is made of silicone resin or medical polyurethane.
5. A filling device, characterized in that: the filling device is used for filling the balloon shell of the nucleus pulposus prosthesis device according to any one of claims 1 to 4, the filling device comprises a filling gun, a filling material storage bin and a driving module, the filling material storage bin is used for storing non-solid filling materials, the filling gun can be inserted into a filling cavity of the balloon shell or is close to a cavity opening of the filling cavity, and the driving module drives the filling materials to be injected into the filling cavity of the balloon shell through the filling gun; wherein, the liquid crystal display device comprises a liquid crystal display device,
the filler comprises an inductor in the filler storage bin and is injected into the filling cavity of the balloon shell together with the filler; or alternatively, the process may be performed,
the filling device also comprises an inductor embedding port communicated with the filling gun, and the inductor is embedded into the filler in the process that the filler passes through the filling gun; or alternatively, the process may be performed,
the filling gun comprises a filling channel and an inductor embedding channel, the driving module drives the filler to be injected into the filling cavity of the balloon shell through the filling channel of the filling gun, and the inductor embedding channel injects the inductor into the filling cavity of the balloon shell.
6. The filling device of claim 5, wherein the filling gun further comprises a plurality of functional channels, the functional channels being one of a filling channel, a curing light setting channel, a sensor embedding channel, a detector setting channel, an image acquisition channel, an auxiliary addition channel, and a filler absorption retraction channel.
7. The filling device of claim 6, further comprising at least one reactant reservoir in communication with the filler reservoir or the filling gun, the reactant reservoir storing an adjunct that is chemically reactive with the filler and is added to the filler during injection of the filler into the filling lumen of the balloon housing.
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| CN112137707B (en) * | 2020-09-27 | 2022-12-13 | 温州医科大学附属第二医院、温州医科大学附属育英儿童医院 | A inflation sacculus and medical device for intervertebral disc plasty |
| CN112716664B (en) * | 2021-04-06 | 2021-06-22 | 珠海维尔康生物科技有限公司 | Fence type bone cement spine fusion device adopting balloon forming |
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