A device for forming bone internal fixation and a method of use

Abstract

The present invention relates to the technical field of medical devices, and discloses a device for forming bone internal fixation and a method of using the device, the device comprising: an expandable balloon, a catheter and a feeding piece; the expandable balloon passes through the bone injury site from the inside of the bone; an optical fiber channel and a photocuring glue channel are provided in the catheter, and a laser optical fiber is arranged in the optical fiber channel; a discharge port and a feed port are provided on the outer wall of the catheter, the discharge port is connected to the expandable balloon, the feed port is connected to the feeding piece, and the photocuring glue is injected into the expandable balloon through the feeding piece. The device for forming bone internal fixation of the present invention inserts an expandable balloon into the bone cavity of the fractured bone, injects photocuring glue into the expandable balloon to expand it, and then irradiates and cures the photocuring glue through the laser optical fiber, thereby forming a bone fixing piece to support and fix the fractured bone, and the entire fracture repair process is simpler and more efficient, and since the photocuring glue will not leak out, damage to soft tissue can be avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a device for forming bone internal fixation and a use method thereof. Background Art

[0002] Fracture treatment techniques include conservative treatment (plaster fixation or splint fixation) and surgical treatment. Surgical treatment is usually for cases where the fracture ends are displaced and open fractures. It includes resetting the two ends of the fracture and using steel wires, steel plates, screws, etc. to support and fix the bones outside the bones. These repair methods are difficult to repair and cause high damage to the patient's soft components and bone tissue, which is not conducive to the patient's postoperative recovery. In addition, there are also technologies that use bone cement mixtures or bone void fillers added to the fractured bones to repair the fracture, but these bone fixation and repair technologies still have certain disadvantages. The bone cement mixture may leak to other areas besides the fractured bone area, causing damage to soft tissues and nerve root pain and contraction. Summary of the invention

[0003] The present invention provides a device for forming bone internal fixation and a method for using the device, which is applied in minimally invasive bone injury surgery to solve the problems existing in the above-mentioned fracture fixation and repair technology.

[0004] A device for forming bone internal fixation, comprising: an expandable balloon, a catheter and a feeding piece;

[0005] An inflatable balloon is passed from inside the bone through the bone injury site;

[0006] An optical fiber channel and an optical adhesive channel are arranged in the catheter, and a laser optical fiber is arranged in the optical fiber channel;

[0007] An outlet and a feed port are provided on the outer wall of the catheter, the outlet is connected to the expandable balloon, and the feed port is connected to the feeding piece, and the light-curing glue is injected into the expandable balloon through the feeding piece to expand the expandable balloon;

[0008] The light emitted by the laser fiber cures the photocurable adhesive in the expandable balloon to form an intrabone fixation device.

[0009] The beneficial effects of adopting the above technical solution are as follows: the device of the present invention connects two fractured bones together and shapes them by arranging an expandable balloon at the fracture site, injecting photocuring glue into the expandable balloon to expand it, and using laser fiber irradiation to cure the photocuring glue to form a bone fixator; the entire operation is a minimally invasive operation, which avoids the huge trauma caused by the operation, the repair process is efficient and simple, and the photocuring glue will not cause harm to the human body.

[0010] Furthermore, a cooling liquid circulation channel is arranged inside the expandable balloon and the catheter, and the cooling liquid circulation channel is closely attached to the outer walls of the optical fiber channel and the optical curing glue channel.

[0011] The beneficial effects of adopting the above technical solution are as follows: photocuring adhesive will generate heat during the laser curing process. By passing coolant into the coolant circulation channel, some of the heat can be taken away, avoiding high temperature damage to the bone tissue in the surgical site, which is beneficial to ensuring the safety of the operation.

[0012] Furthermore, the above-mentioned coolant circulation channel includes a liquid inlet channel and a liquid outlet channel, and the liquid inlet channel and the liquid outlet channel are connected and are bent in a U shape at the front end of the inflatable balloon.

[0013] Furthermore, a Luer two-way valve is provided between the feeding member and the feeding port on the conduit.

[0014] The beneficial effect of adopting the above technical solution is that the two-way Luer valve is provided to facilitate evacuating the inflatable balloon to keep it in a vacuum state.

[0015] Furthermore, the shape and size of the inflatable balloon after expansion are adapted to the internal space of the fracture site.

[0016] Furthermore, the outer wall of the expandable balloon is provided with a plurality of grooves.

[0017] The beneficial effects of adopting the above technical solution are as follows: a groove is set on the outer wall of the inflatable balloon. On the one hand, the friction between the inflatable balloon and the inner surface of the bone cavity can be increased to improve the fixation ability of the inflatable balloon. On the other hand, in special circumstances, the inflatable balloon needs to be used with screws. The setting of the groove can prevent the screws from slipping when being driven in, thereby facilitating the smooth implantation of the screws.

[0018] Furthermore, a detachable interface is provided on the above-mentioned catheter, and the detachable interface is a circle of concave rings along the outer wall of the catheter.

[0019] The beneficial effect of adopting the above technical solution is that after the light-curing adhesive is cured, the catheter can be directly removed from the interface manually without the aid of special tools, making the entire surgical process more convenient.

[0020] Furthermore, the inner wall of the expandable balloon is provided with a developer coating.

[0021] The beneficial effects of adopting the above technical solution are as follows: a developer coating is provided, and when the developer is developed under light or radiation of a specific wavelength, medical personnel can observe the state of the balloon according to the development pattern to guide the operation or perform real-time monitoring.

[0022] Furthermore, the above-mentioned laser optical fiber is connected to the laser power equipment through an optical fiber plug.

[0023] To facilitate the use of the device of the present invention, the present invention also provides a method for forming an intrabone fixation device, using the above-mentioned device, comprising the following steps:

[0024] S1: A hole is opened near the fracture site, a guide wire is inserted, the bone marrow is removed along the guide wire to form an intraosseous channel across the fracture site, and a tearable sheath is placed into the intraosseous channel along the guide wire;

[0025] S2: Open the Luer two-way valve, use the feeding piece to suck out the air in the inflatable balloon and the catheter, ensure that the inflatable balloon and the catheter are in a vacuum state, and close the Luer two-way valve;

[0026] S3: Place the inflatable balloon and part of the catheter into the tearable sheath, adjust the position so that the inflatable balloon spans the fracture site, and then remove the tearable sheath;

[0027] S4: Open the Luer two-way valve and use the feeding piece to inject the light-curing glue into the expandable balloon until the expandable balloon expands to fully contact the inner wall of the intraosseous channel;

[0028] S5: Connect the laser optical fiber to the laser power device, and the laser optical fiber irradiates the photocurable adhesive in the expandable balloon to solidify the photocurable adhesive. While the laser irradiates, coolant is introduced into the coolant circulation channel to avoid bone tissue damage caused by high temperature generated during the irradiation process;

[0029] S6: After the light-curing adhesive is cured, the cured light-curing adhesive and the expandable balloon together form a bone fixation device to support and fix the fracture site;

[0030] S7: Cut off the catheter, leave the bone fixator in the intraosseous channel, and then suture the wound left when opening the hole.

[0031] The present invention has the following beneficial effects:

[0032] (1) The device for forming bone fixation of the present invention inserts an expandable balloon into the bone cavity of the fractured bone, injects photocuring glue into the expandable balloon to expand it, and then irradiates and cures the photocuring glue with a laser optical fiber, thereby forming a bone fixation device to support and fix the fractured bone. The entire fracture repair process is simpler and more efficient, and because the photocuring glue will not leak out, damage to soft tissue can be avoided.

[0033] (2) The entire surgical process using the device of the present invention is a minimally invasive surgery, which is simple and efficient, causes little harm to the patient, can effectively reduce the patient's postoperative pain and discomfort, and promote the healing of the affected area.

[0034] (3) The device of the present invention has a simple structure, low manufacturing cost and simple manufacturing process, which is helpful to reduce the treatment cost of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 It is a schematic diagram of the three-dimensional structure of the device of the present invention;

[0036] Figure 2 It is a front view structural schematic diagram of the device of the present invention;

[0037] Figure 3 for Figure 2 A local enlarged schematic diagram of the middle A;

[0038] Figure 4 for Figure 2 Schematic diagram of the structure of the middle BB section;

[0039] Figure 5 It is a schematic diagram of an axial section of the device of the present invention;

[0040] Figure 6 It is a schematic axial section diagram of the expandable balloon of the present invention.

[0041] In the figure: 1-expandable balloon; 2-catheter; 21-optical fiber channel; 22-photocuring glue channel; 23-cooling liquid circulation channel; 231-liquid inlet channel; 232-liquid outlet channel; 24-detachable interface; 25-discharge port; 26-feed port; 3-Luer two-way valve; 4-feeding piece; 5-optical fiber plug; 6-laser optical fiber. DETAILED DESCRIPTION

[0042] The principles and features of the present invention are described below in conjunction with the accompanying drawings. The examples given are only used to explain the present invention and are not used to limit the scope of the present invention.

[0043] Embodiment 1

[0044] refer to Figures 1 to 6 The present invention provides a device for forming bone intrafixation, including: an expandable balloon 1, a catheter 2, a feeder 4 and a tearable sheath, and a laser optical fiber 6.

[0045] The inflatable balloon 1 is arranged at the end of the catheter 2. The catheter 2 is a medium-hole tube. An optical fiber channel 21 and a photocuring glue channel 22 are arranged in the catheter 2. The two channels are arranged independently and parallel to each other. A laser optical fiber 6 is arranged in the optical fiber channel 21. The front end of the laser optical fiber 6 (the side close to the inflatable balloon 1) extends into the inflatable balloon 1, and the rear end of the laser optical fiber 6 (the side away from the inflatable balloon 1) is connected to the optical fiber plug 5. The laser optical fiber 6 is connected to the laser power device through the optical fiber plug 5 to receive the laser energy emitted by the laser power device. An outlet 25 and an inlet 26 which pass through the photocuring glue channel 22 are provided on the wall of the catheter 2. The outlet 25 is located inside the inflatable balloon 1, and the inlet 26 is far away from the inflatable balloon 1 and connected to the feeding piece 4. The photocuring glue is injected through the feeding piece 4, and the photocuring glue passes through the photocuring glue channel 22 and enters the inflatable balloon 1 from the outlet 25. The photocuring glue is cured under the irradiation of the light emitted by the laser optical fiber 6, and together with the inflatable balloon 1, it forms a bone fixation body.

[0046] It should be noted that the front end of the laser optical fiber 6 is located between the protective layer and the cladding in the expandable balloon 1, and the light emitted by the laser optical fiber 6 can penetrate the cladding to irradiate the photocurable adhesive between the protective layer and the outer layer.

[0047] The laser used in the present invention is visible light or ultraviolet light (depending on the properties of the light-curing adhesive), such as using blue light with a wavelength of 405 nm to irradiate the light-curing adhesive.

[0048] The inflatable balloon 1 is placed in the bone cavity of the fracture site in a deflated state, and the two ends of the inflatable balloon 1 are respectively located inside the two fractured bones, and are used to accommodate the photocuring glue to form a bone fixation device. The shape and size of the inflatable balloon 1 after expansion are fully adapted to the internal space of the fractured bone. After it is fully expanded, it can fully fit the internal space of the bone to be repaired in the bone cavity. In actual use, the shape and size of the inflatable balloon 1 can be customized according to the patient's fracture condition, which is conducive to improving the treatment effect.

[0049] As a preferred embodiment, the material of the expandable balloon 1 is polyethylene terephthalate.

[0050] As a preferred embodiment, the outer wall of the inflatable balloon 1 is provided with a plurality of grooves, which are evenly distributed on the outer wall of the inflatable balloon 1. The shape of the grooves can be circular, square, elliptical or other polygonal. On the one hand, the grooves can increase the friction between the inflatable balloon 1 and the inner surface of the bone cavity to improve the fixation ability of the inflatable balloon 1 in the bone cavity. On the other hand, in some special cases where the inflatable balloon 1 needs to be fixed, the inflatable balloon 1 is used together with screws. The setting of the grooves can prevent the screws from slipping when being nailed in, thereby facilitating the smooth implantation of the screws.

[0051] As a preferred embodiment, a coolant circulation channel 23 is arranged inside the expandable balloon 1 and the catheter 2. The coolant circulation channel 23 is closely attached to the outer walls of the optical fiber channel 21 and the photocuring adhesive channel 22 and is passed with coolant. The coolant circulation channel 23 includes an inlet channel 231 and an outlet channel 232. The inlet channel 231 and the outlet channel 232 are connected and bent in a U shape at the front end of the expandable balloon 1, which is used to take away the heat when the photocuring adhesive is cured to avoid high temperature damage to bone tissue. The coolant in the coolant circulation channel 23 can be cold water or cold air.

[0052] As a preferred embodiment, the catheter 2 is provided with a detachable interface 24, which is a concave ring along the outer wall of the catheter 2, through which the catheter 2 and the expandable balloon 1 can be easily separated without the use of tools. Of course, the detachable interface 24 can also be set as a threaded interface, and the catheters on both sides of the detachable interface 24 are respectively provided with external threads and internal threads to form a threaded connection.

[0053] Before injecting the photocuring glue into the expandable balloon 1, the expandable balloon 1 needs to be evacuated. As a preferred embodiment, a Luer two-way valve 3 is provided between the feeding member 4 and the feeding port 26 on the catheter 2. After the expandable balloon 1 is evacuated through the Luer two-way valve 3, the Luer two-way valve 3 is closed to maintain the vacuum state. The expandable balloon 1 in the vacuum state is under negative pressure, which is conducive to quickly feeding the photocuring glue into the expandable balloon 1 and preventing the photocuring glue from being retained in the photocuring glue channel 22 of the catheter 2.

[0054] As a preferred embodiment, the feeding member 4 is a syringe.

[0055] As a preferred embodiment, the inner wall of the inflatable balloon 1 is provided with a developer coating, and the developer coating can be partially coated or fully coated; when partial coating is adopted, the coating can be set to a spiral line shape along the axial direction of the inflatable balloon 1, and can be developed under the irradiation of the corresponding radiation or light of the developer, so as to facilitate the intuitive observation and operation of medical staff.

[0056] Depending on the specific medical procedure and the availability of medical equipment, the material of the developer may vary. For example, the developer coating may contain a radioactive developer, such as iodine or bismuth. When the expandable balloon 1 is inflated or expanded, the radioactive developer will produce a contrast effect in X-rays or other imaging examinations, allowing the doctor to clearly see the position and shape of the expandable balloon; or, the developer coating may contain a magnetic resonance developer, such as a complex containing gadolinium, which can provide a high-contrast image during magnetic resonance imaging (MRI), making the expandable balloon 1 more visible in the image; or, fluorescent developers may be added to the developer coating, which emit fluorescence under a specific wavelength of light. By using appropriate light sources and detection equipment, doctors can observe the fluorescent signal of the expandable balloon 1 to guide operations or conduct real-time monitoring.

[0057] Embodiment 2

[0058] This embodiment provides a method for forming an intrabone fixation device, using the device described in Embodiment 1, and comprising the following steps:

[0059] S1: A hole is opened near the fracture site, a guide wire is inserted, the bone marrow is removed along the guide wire to form an intraosseous channel across the fracture site, and a tearable sheath is placed into the intraosseous channel along the guide wire;

[0060] S2: Open the Luer two-way valve 3, use the feeding piece 4 to suck out the air in the expandable balloon 1 and the catheter 2, ensure that the expandable balloon 1 and the catheter 2 are in a vacuum state, and close the Luer two-way valve 3;

[0061] S3: placing the expandable balloon 1 and a portion of the catheter 2 into the tearable sheath, adjusting the position so that the expandable balloon 1 spans the fracture site, and then removing the tearable sheath;

[0062] S4: Open the Luer two-way valve 3, and use the feeding member 4 to inject the light-curing glue into the expandable balloon 1 until the expandable balloon 1 expands to fully contact the inner wall of the intraosseous channel;

[0063] S5: Connect the laser optical fiber 6 to the laser power device, and the laser optical fiber 6 irradiates the light-curing glue in the expandable balloon 1 to solidify the light-curing glue. While the laser irradiates, coolant is introduced into the coolant circulation channel 23 to avoid bone tissue damage caused by the high temperature generated during the irradiation process;

[0064] S6: After the light-curing adhesive is cured, the cured light-curing adhesive and the expandable balloon 1 together form a bone fixation device to support and fix the fracture site;

[0065] S7: Cut off the catheter 2, leave the bone fixing device in the intraosseous channel, and then suture the wound left when opening the hole.

[0066] When the catheter 2 is cut off in step S7, the catheter 2 and the expandable balloon 1 are first separated through the detachable interface 24, and then the portion of the catheter 2 remaining outside the human body is cut off from the opening position using a special cutting tool.

[0067] The above description is only a preferred embodiment of the present invention, which does not represent all possible forms of the present invention, and the protection scope of the present invention is not limited to such special statements and embodiments. According to the technical enlightenment disclosed by the present invention, various other modifications and improvements that do not deviate from the essence of the present invention are made, and these modifications and improvements are still within the protection scope of the present invention.

Claims

1. A device for forming bone fixation, characterized in that: include: An expandable balloon (1), a catheter (2) and a feeder (4); The expandable balloon (1) passes through the bone injury site from inside the bone; An optical fiber channel (21) and an optical curing glue channel (22) are arranged in the catheter (2), and a laser optical fiber (6) is arranged in the optical fiber channel (21); An outlet (25) and an inlet (26) are provided on the outer wall of the catheter (2), the outlet (25) is in communication with the expandable balloon (1), and the inlet (26) is in communication with the feeding member (4), and light-curing glue is injected into the expandable balloon (1) through the feeding member (4) to expand the expandable balloon (1); The light emitted by the laser optical fiber (6) causes the light-curing glue in the expandable balloon (1) to solidify to form a bone fixation device. The expandable balloon (1) and the catheter (2) are provided with a cooling liquid circulation channel (23), and the cooling liquid circulation channel (23) is closely attached to the outer walls of the optical fiber channel (21) and the optical curing glue channel (22). The cooling liquid circulation channel (23) comprises a liquid inlet channel (231) and a liquid outlet channel (232), wherein the liquid inlet channel (231) and the liquid outlet channel (232) are connected and are bent in a U shape at the front end of the expandable balloon (1), the outer wall of the expandable balloon (1) is provided with a plurality of grooves, and the inner wall of the expandable balloon (1) is provided with a developer coating.

2. The device for forming bone fixation according to claim 1, characterized in that: A Luer two-way valve (3) is provided between the feeding piece (4) and the feeding port (26) on the conduit (2).

3. The device for forming bone fixation according to claim 1, characterized in that: The shape and size of the inflatable balloon (1) after expansion are adapted to the internal space of the fracture site.

4. The device for forming bone fixation according to claim 1, characterized in that: The conduit (2) is provided with a detachable interface (24), and the detachable interface (24) is a concave ring along the outer wall of the conduit (2).

5. The device for forming bone internal fixation according to any one of claims 1 to 4, characterized in that: The laser optical fiber (6) is connected to the laser power equipment via an optical fiber plug (5).

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