Bone cement injection device

Abstract

The present invention relates to a bone cement injection device and, more specifically, to a bone cement injection device comprising: a bone cement injection tool; and a syringe for injecting bone cement. The syringe for bone cement injection of the present invention uses polyphenylsulfone as a main component such that even when filled with bone cement used in bone-related surgery, the syringe does not undergo deformation and does not release carcinogens, thereby enabling safer use. In addition, the scale of the syringe for bone cement injection of the present invention is displayed as an engraved marking rather than with conventional xylene dye, such that the scale is not erased by organic solvents that dissolve bone cement and does not cause carcinogens, thereby providing a safe syringe for bone cement injection.

Description

bone cement injection device

[0001] The present invention relates to a bone cement injection device, and more particularly, to a bone cement injection device including a bone cement injection device; and a syringe for bone cement injection.

[0002] Syringes, a symbol of medicine, were initially developed from metal or glass. With the invention of polypropylene in the mid-20th century, these early metal or glass syringes were replaced by today's disposable plastic syringes, with over 40 billion currently used annually.

[0003] Conventional plastic syringes, primarily made of polypropylene, are commonly used for direct injection into the human epidermis, muscles, and blood vessels. No safety issues have been identified for these applications. However, advancements in medicine have led to the emergence of new types of surgical materials, including anticancer drugs, contrast media, radioisotopes, and artificial cements, as well as direct injections into deep-seated organs and bones.

[0004] In particular, in bone-related surgeries that involve injecting artificial cement into the bone, when a conventional disposable plastic syringe is filled with a mixed liquid of artificial cement and organic solvent, the syringe frequently bends and is easily twisted even with a slight pressure, and the dye on the syringe markings melts, polluting the surgical environment.

[0005] In addition, there is a problem in that the high heat that is inevitably generated during the process of dissolving artificial cement in an organic solvent acts as a catalyst to cause a reaction between polypropylene and the organic solvent, which breaks the polypropylene molecular structure chain, weakening the syringe strength and causing it to bend, making it impossible to quantitatively inject a consistent amount.

[0006] In addition, there is a problem that xylene dye, the main ingredient of the syringe scale, can melt when it comes into contact with organic solvents and function as a carcinogen at the surgical site.

[0007] Therefore, there is a growing need for safe materials that can solve the problems of disposable plastic syringes made mainly of polypropylene, which are conventionally used in bone-related surgeries using artificial cement.

[0008] The purpose of the present invention is to provide a syringe for injecting bone cement, which can be used safely without causing deformation of the syringe shape or causing carcinogens even when filled with bone cement used in bone-related surgery.

[0009] Another object of the present invention is to provide a bone cement injection device that is connected to and used with the above-mentioned bone cement injection syringe.

[0010] Another object of the present invention is to provide a bone cement injection device including the above-described bone cement injection syringe; and a bone cement injection device.

[0011] The technical problems to be solved by the invention are not limited to the technical problems mentioned above, and other technical problems not mentioned can be clearly understood by a person having ordinary skill in the art from the description of the present invention.

[0012] The present invention provides a bone cement injection device comprising a pipe for inserting bone cement into a bone and a joint formed integrally at the other end of the pipe and capable of being joined to a bone cement injection syringe; and a bone cement injection syringe; wherein the bone cement injection syringe comprises a cylinder for containing bone cement; an injection joint connected to the joint of the bone cement injection device; and a plunger for applying pressure to the bone cement.

[0013] In the present invention, the cylinder is characterized in that it is manufactured from polyphenylsulfone (PPSU).

[0014] In the present invention, the cylinder is characterized in that it includes a scale engraved on the outer surface of the cylinder, and a temperature sensor is mounted on the inner surface of the cylinder.

[0015] In the present invention, the injection part is characterized in that it has a female screw corresponding to the fastening part, and the fastening part is characterized in that it has a male screw corresponding to the injection part.

[0016] In addition, the present invention provides a bone cement injection method including the steps of: preparing bone cement; putting the prepared bone cement into a cylinder of a bone cement injection syringe; measuring the temperature of the bone cement with a temperature sensor of the bone cement injection syringe containing the bone cement; connecting the bone cement injection syringe containing the bone cement to the bone cement injection device; and injecting the bone cement into a bone.

[0017] The bone cement injection syringe of the present invention uses polyphenylsulfone as its main component, so that even when filled with bone cement used in bone-related surgery, the syringe shape does not change and does not cause carcinogens, making it safer to use.

[0018] In addition, the graduations of the bone cement injection syringe of the present invention are marked with engravings rather than with conventional xylene dyes, so that they are not erased by organic solvents that dissolve bone cement and do not cause carcinogens, thereby providing a safe bone cement injection syringe.

[0019] In addition, the injection portion of the bone cement injection syringe of the present invention and the connection portion of the bone cement injection device are characterized by being connected integrally through a female screw and a male screw, so that when bone cement is injected, the bone cement does not leak out from the injection portion, thereby preventing contamination of the area around the surgical site.

[0020] The effects of the present invention are not limited to the effects mentioned above, and other effects not mentioned will be clearly understood by those skilled in the art from the description of the claims.

[0021] FIG. 1 is a perspective view of a bone cement injection device according to one embodiment of the present invention.

[0022] Figure 2 is a partially enlarged cross-sectional view of a fastening portion of a bone cement injection device according to one embodiment of the present invention.

[0023] FIG. 3 is a perspective view schematically illustrating a syringe for injecting bone cement according to one embodiment of the present invention.

[0024] Figure 4 is a partially enlarged cross-sectional view of an injection unit of a bone cement injection device according to one embodiment of the present invention.

[0025] FIG. 5 is a schematic diagram showing a process of injecting bone cement into the spine using a bone cement injection device and a bone cement injection syringe according to one embodiment of the present invention.

[0026] Figure 6 is a drawing visualizing the problems of a conventional syringe made mainly of polypropylene.

[0027] The terms used in this specification have been selected from widely used, current terms, taking into account the functions of the present invention. However, these terms may vary depending on the intentions of those skilled in the art, precedents, the emergence of new technologies, etc. Furthermore, in certain cases, terms may be arbitrarily selected by the applicant, and in such cases, their meanings will be described in detail in the relevant description of the invention. Therefore, the terms used in this invention should not be defined simply as names, but rather based on their inherent meanings and the overall content of the present invention.

[0028] Unless otherwise defined, all terms used herein, including technical or scientific terms, have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Terms defined in commonly used dictionaries should be interpreted as having a meaning consistent with their meaning in the context of the relevant technology, and shall not be interpreted in an idealized or overly formal sense unless explicitly defined herein.

[0029] Numerical ranges are inclusive of the numbers defined in the ranges above. Every maximum numerical limitation given throughout this specification includes every lower numerical limitation, as if that lower numerical limitation were explicitly stated. Every minimum numerical limitation given throughout this specification includes every higher numerical limitation, as if that higher numerical limitation were explicitly stated. Every numerical limitation given throughout this specification will include every better numerical range within that broader numerical range, as if that narrower numerical limitation were explicitly stated.

[0030] Hereinafter, some embodiments of the present invention will be described in detail with reference to exemplary drawings. When designating components in each drawing, it should be noted that, where possible, identical components will be given the same reference numbers, even if they appear in different drawings. Furthermore, when describing the present invention, detailed descriptions of known related structures or functions will be omitted if they are deemed to obscure the gist of the present invention.

[0031] In addition, when describing components of the present invention, terms such as first, second, A, B, (a), (b), etc. may be used. These terms are only intended to distinguish the components from other components, and the nature, order, or sequence of the components are not limited by the terms. When it is described that a component is "connected," "coupled," "fastened," or "connected" to another component, it should be understood that the component may be directly connected or connected to the other component, but another component may also be "connected," "coupled," "fastened," or "connected" between each component.

[0032]

[0033] Hereinafter, the present invention will be described in detail.

[0034]

[0035] FIG. 1 is a perspective view of a bone cement injection device (100) according to an embodiment of the present invention, and FIG. 2 is a partially enlarged cross-sectional view of a fastening part (121) of a bone cement injection device (100) according to an embodiment of the present invention.

[0036] The above bone cement injection device (100) comprises, as illustrated in FIG. 1, a handle (120) that can be held by a user, and a pipe (110) formed integrally with the handle (120).

[0037] The above handle (120) has a groove formed into which a finger can rest to enhance the grip when the user holds it.

[0038] The above handle (120) may be integrally formed with the other end (112) of the pipe (110), and a fastening portion (121) having a screw shape may be included in the other end (112) in a protruding shape.

[0039] The above-mentioned fastening portion (121) is connected to the internal space of the pipe (110), so that bone cement can be distributed into the interior of the pipe (110) through the bone cement injection syringe (200).

[0040] The above pipe (110) is fixed integrally with the handle (120). The above pipe (110) is a body having a cross-section that is roughly in the shape of a tube, and one end (111) thereof is formed to have a thickness similar to that of the pipe (110) as shown in Fig. 1, and more specifically, one end (111) thereof is formed not to be sharp.

[0041]

[0042] FIG. 3 is a perspective view schematically illustrating a bone cement injection syringe (200) according to one embodiment of the present invention, and FIG. 4 is a partially enlarged cross-sectional view of the injection portion (230) of the bone cement injection syringe (200) of FIG. 1. In addition, FIG. 5 is a schematic diagram illustrating a process of injecting bone cement into a spine (300) using a bone cement injection device (100) and a bone cement injection syringe (200) according to one embodiment of the present invention.

[0043] As shown in FIGS. 3 and 4, a syringe (200) for bone cement injection according to one embodiment of the present invention may include a cylinder (210), a pressure portion (220), and an injection portion (230).

[0044] The cylinder (210) can accommodate a substance to be injected therein. The substance to be injected may be bone cement as an example of the present invention. More specifically, the bone cement may be manufactured by mixing a first powder component and a liquid component to produce a mixture, and then mixing a second powder component into the mixture.

[0045] The first powder component may be composed of methacrylate-methyl acrylate (MMA-MA), bismuth oxide (Bi2O3), and gentamicin (GM), and the liquid component may be composed of non-crosslinking MMA monomer and N,N-dimethyl-para-toluidine (DMPT). In addition, the second powder component may be composed of methacrylate-methyl acrylate (MMA-MA), benzoyl peroxide (BPO), and gentamicin (GM).

[0046] The first powder component may include 1 to 7 parts by weight, 2 to 6 parts by weight, or 3 to 5 parts by weight of bismuth oxide (Bi2O3) based on 6.5 parts by weight of methacrylate-methyl acrylate (MMA-MA), and the first powder component may include 0.1 to 0.9 parts by weight, 0.2 to 0.8 parts by weight, 0.3 to 0.7 parts by weight, or 0.4 to 0.6 parts by weight of gentamicin (GM) based on 6.5 parts by weight of methacrylate-methyl acrylate (MMA-MA).

[0047] Preferably, the first powder component may be composed of 6.5 parts by weight of methacrylate-methyl acrylate (MMA-MA), 4 parts by weight of bismuth oxide (Bi2O3), and 0.5 parts by weight of gentamicin (GM), and more preferably, it may be composed of 6.5 g of methacrylate-methyl acrylate (MMA-MA), 4 g of bismuth oxide (Bi2O3), and 0.5 g of gentamicin (GM).

[0048] The liquid component may include 0.05 to 0.4 parts by weight, 0.1 to 0.3 parts by weight, or 0.15 to 0.25 parts by weight of N,N-dimethyl-para-toluidine (DMPT) based on 15 parts by weight of non-crosslinking MMA monomer.

[0049] Preferably, the liquid component may be composed of 0.2 parts by weight of N,N-dimethyl-para-toluidine (DMPT) based on 15 parts by weight of non-crosslinking MMA monomer, and more preferably, it may be composed of 15 g of non-crosslinking MMA monomer and 0.2 g of N,N-dimethyl-para-toluidine (DMPT).

[0050] The second powder component may include 0.1 to 1.0 parts by weight, 0.2 to 0.9 parts by weight, 0.3 to 0.8 parts by weight, 0.4 to 0.7 parts by weight, 0.4 to 0.6 parts by weight, or 0.45 to 0.55 parts by weight of benzoyl peroxide (BPO) based on 30 parts by weight of methacrylate-methyl acrylate (MMA-MA).

[0051] The second powder component may include 0.1 to 1.0 parts by weight, 0.2 to 0.9 parts by weight, 0.3 to 0.8 parts by weight, 0.4 to 0.7 parts by weight, 0.4 to 0.6 parts by weight, or 0.45 to 0.55 parts by weight of gentamicin (GM) based on 30 parts by weight of methacrylate-methyl acrylate (MMA-MA).

[0052] Preferably, the second powder component may be composed of 0.5 parts by weight of benzoyl peroxide (BPO) and 0.5 parts by weight of gentamicin (GM) based on 30 parts by weight of methacrylate-methyl acrylate (MMA-MA), and more preferably, it may be composed of 30 g of methacrylate-methyl acrylate (MMA-MA), 0.5 g of benzoyl peroxide (BPO), and 0.5 g of gentamicin (GM).

[0053] The above pressure unit (220) may include a gasket (221) and a plunger (222), and according to one embodiment of the present invention, the bone cement contained in the cylinder (210) of the bone cement injection syringe (200) may be pressurized by the pressure unit (220) to supply the bone cement to the surgical site.

[0054] The above gasket (221) may be characterized as being manufactured from a silicone material, and the seal (222) may be characterized as being manufactured from polyphenylsulfone (PPSU).

[0055]

[0056] The above injection part (230) may have a female screw (231) corresponding to the above fastening part (121).

[0057] The cylinder (210) is a tubular body having a cross-section that is approximately a tube shape, and a temperature sensor (213) is further included on the inner surface of the cylinder (210) to measure the temperature of a material to be injected. More specifically, the material to be injected may be bone cement, and the bone cement may be injected when the temperature of the bone cement is measured as 45 to 55°C by the temperature sensor (213). Preferably, the bone cement may be injected when the temperature of the bone cement is measured as 48 to 52°C, and more preferably, the bone cement may be injected when the temperature of the bone cement is 50.4°C.

[0058] As illustrated in FIG. 3, a graduation indicating the amount of a substance to be injected contained within the cylinder (210) may be marked on the outer surface of the cylinder (210). The graduation may be divided into a major graduation (211) and a minor graduation (212). The cylinder (210) has a flat surface, the flat surface extending along the longitudinal direction of the cylinder (210), and the graduation may be formed along the flat surface. In addition, the flat surface may be formed perpendicular to a central axis along the longitudinal direction of the cylinder (210).

[0059] The above graduations may be engraved. If the graduations are engraved, they may be susceptible to surface scratches and wear, and the embossed graduations may disappear due to scratches. Conversely, if the graduations are engraved, the problem of the graduations disappearing due to surface scratches or wear can be resolved, and even in situations where the graduations are visually difficult to identify due to bone cement, they can be identified by touch.

[0060] The above-mentioned engraved graduations may be composed of graduations indicating capacities of 0.5 and 1 mL, and the graduations in units of 0.5 mL may be referred to as sub-graduations (212), and the graduations in units of 1 mL may be referred to as major graduations (211). More specifically, the major graduations (211) and sub-graduations (212) may be indicated as circular engravings according to the diameter of the flat surface.

[0061] When using a syringe (200) for bone cement injection according to one embodiment of the present invention, the practitioner can inject an accurate amount while visually checking the scale of the cylinder (210).

[0062] According to one embodiment of the present invention, the cylinder (210) of the bone cement injection syringe (200) may have a capacity of 1 mL capable of containing a substance to be injected, and accordingly, the main graduation (211) and the sub-graduation (212) may be displayed one each.

[0063] According to one embodiment of the present invention, by marking the graduations of the syringe (200) for injecting bone cement with engravings rather than dye, the problem of the graduations marked with dye dissolving due to the organic solvent contained in the bone cement when injecting the bone cement is solved, thereby enabling an accurate amount to be injected.

[0064]

[0065] In bone-related surgeries that involve injecting artificial cement into the bone, when a conventional disposable plastic syringe is filled with a mixture of artificial cement and an organic solvent, the syringe frequently bends and is easily twisted even with a slight pressure, and the dye on the syringe markings may dissolve, contaminating the surgical environment.

[0066] In particular, conventional disposable medical syringes primarily composed of polypropylene frequently suffer from the problems described above. Figure 6 is a drawing of a conventional disposable syringe with a cylinder and plunger made of polypropylene. It can be seen that the shape is distorted and the dye on the syringe markings has dissolved due to artificial cement and organic solvents.

[0067] The present invention has been devised to solve the problems of the prior art described above, and is characterized in that the cylinder (210) and the plunger (222) of the bone cement injection syringe (200) are made of polyphenylsulfone (PPSU), so that even when bone cement is filled and used, the shape of the syringe does not change and no carcinogens are generated.

[0068]

[0069] In addition, the present invention can provide a bone cement injection method using the bone cement injection device described above.

[0070] The above bone cement injection method may include a step of preparing bone cement; a step of putting the prepared bone cement into a cylinder (210) of a bone cement injection syringe (200) as described above; a step of measuring the temperature of the bone cement with a temperature sensor (213) of the bone cement injection syringe (200) containing the bone cement; a step of connecting the bone cement injection syringe (200) containing the bone cement to a bone cement injection device (100) as described above; and a step of injecting the bone cement into a bone.

[0071]

[0072] The step of preparing the above bone cement may refer to a step of preparing bone cement to be injected into an object to be operated on, and the bone cement may be characterized in that it is prepared by mixing a first powder component and a liquid component to prepare a mixture, and mixing a second powder component into the mixture.

[0073] The first powder component may be composed of methacrylate-methyl acrylate (MMA-MA), bismuth oxide (Bi2O3), and gentamicin (GM), and the liquid component may be composed of non-crosslinking MMA monomer and N,N-dimethyl-para-toluidine (DMPT). In addition, the second powder component may be composed of methacrylate-methyl acrylate (MMA-MA), benzoyl peroxide (BPO), and gentamicin (GM).

[0074] The first powder component may include 1 to 7 parts by weight, 2 to 6 parts by weight, or 3 to 5 parts by weight of bismuth oxide (Bi2O3) based on 6.5 parts by weight of methacrylate-methyl acrylate (MMA-MA), and the first powder component may include 0.1 to 0.9 parts by weight, 0.2 to 0.8 parts by weight, 0.3 to 0.7 parts by weight, or 0.4 to 0.6 parts by weight of gentamicin (GM) based on 6.5 parts by weight of methacrylate-methyl acrylate (MMA-MA).

[0075] Preferably, the first powder component may be composed of 6.5 parts by weight of methacrylate-methyl acrylate (MMA-MA), 4 parts by weight of bismuth oxide (Bi2O3), and 0.5 parts by weight of gentamicin (GM), and more preferably, it may be composed of 6.5 g of methacrylate-methyl acrylate (MMA-MA), 4 g of bismuth oxide (Bi2O3), and 0.5 g of gentamicin (GM).

[0076] The liquid component may include 0.05 to 0.4 parts by weight, 0.1 to 0.3 parts by weight, or 0.15 to 0.25 parts by weight of N,N-dimethyl-para-toluidine (DMPT) based on 15 parts by weight of non-crosslinking MMA monomer.

[0077] Preferably, the liquid component may be composed of 0.2 parts by weight of N,N-dimethyl-para-toluidine (DMPT) based on 15 parts by weight of non-crosslinking MMA monomer, and more preferably, it may be composed of 15 g of non-crosslinking MMA monomer and 0.2 g of N,N-dimethyl-para-toluidine (DMPT).

[0078] The second powder component may include 0.1 to 1.0 parts by weight, 0.2 to 0.9 parts by weight, 0.3 to 0.8 parts by weight, 0.4 to 0.7 parts by weight, 0.4 to 0.6 parts by weight, or 0.45 to 0.55 parts by weight of benzoyl peroxide (BPO) based on 30 parts by weight of methacrylate-methyl acrylate (MMA-MA).

[0079] The second powder component may include 0.1 to 1.0 parts by weight, 0.2 to 0.9 parts by weight, 0.3 to 0.8 parts by weight, 0.4 to 0.7 parts by weight, 0.4 to 0.6 parts by weight, or 0.45 to 0.55 parts by weight of gentamicin (GM) based on 30 parts by weight of methacrylate-methyl acrylate (MMA-MA).

[0080] Preferably, the second powder component may be composed of 0.5 parts by weight of benzoyl peroxide (BPO) and 0.5 parts by weight of gentamicin (GM) based on 30 parts by weight of methacrylate-methyl acrylate (MMA-MA), and more preferably, it may be composed of 30 g of methacrylate-methyl acrylate (MMA-MA), 0.5 g of benzoyl peroxide (BPO), and 0.5 g of gentamicin (GM).

[0081]

[0082] The step of putting the prepared bone cement into the cylinder (210) of the bone cement injection syringe (200) as described above may include, but is not limited to, the step of positioning the injection portion (230) of the bone cement injection syringe (200) in the prepared bone cement; the step of pulling the plunger (222) of the bone cement injection syringe (200) in a direction opposite to the injection direction; and the step of putting the bone cement into the cylinder (210) of the bone cement injection syringe (200).

[0083]

[0084] The step of measuring the temperature of the bone cement with the temperature sensor (213) of the bone cement injection syringe (200) containing the bone cement is a step designed to inject the bone cement at an optimal temperature when injecting the bone cement into the subject to be operated on, and the optimal temperature when injecting the bone cement may be 45 to 55°C, preferably 48 to 52°C, and more preferably 50.4°C.

[0085]

[0086] The step of connecting the bone cement injection syringe (200) containing the bone cement to the bone cement injection device (100) described above may be characterized in that the injection portion (230) of the bone cement injection syringe (200) and the connection portion (121) of the bone cement injection device (100) are combined and connected. The bone cement injection device (100) may include a connection portion (121) having a male screw shape protruding from the other end (112) of the pipe (110), and the injection portion (230) of the bone cement injection syringe (200) may have a female screw (231) corresponding to the connection portion (121).

[0087]

[0088] The step of injecting bone cement into the bone may be a step of injecting bone cement into the bone of an individual to be operated on, and preferably, may be a step of injecting bone cement into the spine (300) of an individual to be operated on.

[0089] The step of injecting bone cement into the bone may include the step of positioning one end (111) of the bone cement injection device (100) into the spine (300) of the subject to be operated on; the step of pressurizing bone cement contained in the cylinder (210) of the bone cement injection syringe (200) by the pressure unit (220); and the step of injecting the bone cement into the spine (300) of the subject to be operated on.

[0090]

[0091] From the above description, those skilled in the art will understand that the present invention can be implemented in other specific forms without altering its technical spirit or essential features. In this regard, it should be understood that the embodiments described above are illustrative in all respects and are not limiting.

[0092]

[0093] [Explanation of symbols]

[0094] 100: Bone cement injection device

[0095] 110: Pipe

[0096] 111: First part

[0097] 112: Other end

[0098] 120: Handle

[0099] 121: Fastening

[0100] 200: Syringe for bone cement injection

[0101] 210: Cylinder

[0102] 211: Main scale

[0103] 212: Sub-scale

[0104] 213: Temperature sensor

[0105] 220: Pressure section

[0106] 221: Gasket

[0107] 222: Mill

[0108] 230: Injection part

[0109] 231: Female screw

[0110] 300: Spine

Claims

1. A pipe for inserting bone cement into the bone and A bone cement injection device including a joint formed integrally at the other end of the above pipe and capable of being connected to a bone cement injection syringe; and A syringe for injecting bone cement; The above bone cement injection syringe A cylinder containing bone cement; An injection part connected to the fastening part of the above bone cement injection device; and A squeegee applying pressure to the above bone cement; A bone cement injection device characterized by including a .

2. In paragraph 1, The above cylinder A bone cement injection device characterized by being manufactured from polyphenylsulfone (PPSU).

3. In paragraph 1, The above cylinder Includes a scale engraved on the outer surface of the cylinder, A bone cement injection device characterized in that a temperature sensor is mounted on the inner surface of the cylinder.

4. In paragraph 1, The above injection part It is characterized by having a female screw corresponding to the above-mentioned fastening part, The above fastening part A bone cement injection device characterized by having a male screw corresponding to the above injection portion.

5. Step for preparing bone cement; A step of putting the prepared bone cement into the cylinder of the bone cement injection syringe according to Article 1; A step of measuring the temperature of the bone cement using a temperature sensor of a bone cement injection syringe containing the above bone cement; A step of connecting a bone cement injection syringe containing the above bone cement to a bone cement injection device according to claim 1; and Step of injecting bone cement into the bone; A method of injecting bone cement comprising:

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