Shape controllable sinus balloon catheter

Abstract

The application relates to the technical field of medical devices, in particular to a shape-controllable nasal sinus balloon catheter which comprises a main catheter, an adjusting ring and an elastic piece, the inner side of the adjusting ring is provided with a sliding block, the end of the sliding block away from the adjusting ring is provided with an annular plate, a groove is formed in the side of the annular plate close to the adjusting ring, and the elastic piece is located on the two sides of the annular plate. By arranging the adjusting ring, physiological saline flows to the branch pipe through the shunt, flows into the balloon through the branch pipe, and makes the balloon expand. In the process, the adjusting ring drives the sliding block to slide to the clamping block in the groove by rotating the adjusting ring, the circular ring formed by the uniformly-distributed annular plates is gradually reduced, the main catheter is contracted, the speed of the physiological saline entering the balloon is controlled, and the effect of controlling the expansion size of the balloon is achieved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a shape-controllable sinus balloon catheter. Background Technology

[0002] Inflammation of one or more sinuses is called sinusitis. The sinuses involved include the maxillary sinus, ethmoid sinus, frontal sinus, and sphenoid sinus. This is a disease with a high incidence rate in the population, which affects the quality of life of patients. Sinusitis can be divided into two types: acute sinusitis and chronic sinusitis. Acute sinusitis is mostly caused by upper respiratory tract infection, and bacterial and viral infections can occur simultaneously. Chronic sinusitis is more common than acute sinusitis, often involving multiple sinuses simultaneously. Treatment for sinusitis involves the use of a sinus balloon catheter, which is used to dilate the occluded maxillary, frontal, and sphenoid sinus ostia. Because the size and shape of the sinus ostia vary from person to person, the balloon in the sinus balloon catheter needs to be infused with fluid according to the specific situation during surgery to inflate it to the appropriate size. Since the infusion of fluid into the balloon is performed outside the nasal cavity, it is difficult to control the exact size and shape of the balloon. Furthermore, because sinus balloon catheters are relatively simple devices, the means to control the exact size and shape of the balloon can only be used with them and cannot be adapted to other similar medical devices. Summary of the Invention

[0003] To address the aforementioned problems in the existing technology, a shape-controllable sinus balloon catheter is provided.

[0004] The specific technical solution is as follows:

[0005] A shape-controllable sinus balloon catheter includes a main tube, an adjusting ring, and an elastic element. The main tube has a guide strip inlet at one end, an inlet fluid on one side of the guide strip inlet, and inlet ports on both sides of the inlet fluid. A branch fluid is located at the end of the main tube away from the guide strip inlet, with a branch port on the side of the branch fluid away from the main tube. A branch tube is located at the end of the branch tube away from the branch port, and a balloon is located at the end of the branch tube away from the branch port. A slider is located inside the adjusting ring, and an annular plate is located at the end of the slider away from the adjusting ring. A groove is formed on the side of the annular plate near the adjusting ring. The elastic element is located on both sides of the annular plate.

[0006] Preferably, the guide bar inlet is threadedly connected to the inlet fluid, the inlet fluid is threadedly connected to the inlet port, the inlet fluid is threadedly connected to the main guide pipe, and the distributor fluid is threadedly connected to the end of the main guide pipe away from the inlet fluid.

[0007] Preferably, the diversion ports are symmetrically distributed, the diversion ports are fixedly connected to the diversion fluid, the branch pipe is threadedly connected to the diversion ports, and the end of the branch pipe away from the diversion ports is threadedly connected to the balloon.

[0008] Preferably, the adjusting ring is sleeved on the outside of the main guide tube, the sliders are evenly distributed, and the sliders are fixedly connected to the adjusting ring.

[0009] Preferably, the end of the slider away from the adjusting ring is connected to the annular plate through the groove, and a locking block is provided on the side of the groove away from the slider.

[0010] Preferably, the annular plates are evenly distributed and located on the outer wall of the main tube, the grooves are inclined arc shapes, and the locking blocks are located on the grooves and fixedly connected to the annular plates.

[0011] Preferably, the elastic elements are uniformly distributed and are fixedly connected to the annular plate.

[0012] Preferably, the raw materials for preparing the annular plate, by weight, include: 70-120 parts resin, 10-25 parts plasticizer, 2-10 parts reinforcing agent, 0.5-3 parts lubricant, 3-15 parts filler, 0.2-4 parts stabilizer, and 0.1-2 parts processing aid.

[0013] Preferably, the resin is selected from one or more of acrylic resin, epoxy resin, PVC resin, phenolic resin, and PI resin.

[0014] Preferably, the resin is acrylic resin and PVC resin in a mass ratio of 1:(20-50).

[0015] Preferably, the acrylic resin is an amino acrylic resin, purchased from Changzhou Houding Chemical Co., Ltd., model HD-1024.

[0016] Preferably, the PVC resin has an average degree of polymerization of 1000-2000, such as SG5 purchased from Hebei Suhaote Chemical Co., Ltd., with an average degree of polymerization of 1000-1100.

[0017] Preferably, the plasticizer is selected from one or more of the following: triethyl citrate, acetylated tributyl citrate, tri-n-hexyl citrate, tri(2-propylheptyl) citrate, polypropylene sebacate, trioctyl trimellitate, tri(n-octyl-n-decyl) trimellitate, epoxidized soybean oil, epoxidized fatty acid butyl ester, epoxidized fatty acid octyl ester, and dioctyl tetrahydrophthalate.

[0018] Preferably, the plasticizer is triethyl citrate and polypropylene sebacate in a mass ratio of (3-7):1.

[0019] Preferably, the reinforcing agent is selected from carbon black and silica.

[0020] Preferably, the reinforcing agent is silica.

[0021] Preferably, the silica is fumed silica produced by gasification.

[0022] Preferably, the lubricant is selected from one or more of stearic acid, polyethylene wax, calcium stearate, zinc stearate, white oil, and silicone oil.

[0023] Preferably, the lubricant is white oil.

[0024] Preferably, the filler is selected from one or more of calcium carbonate, silicon dioxide, kaolin, silica powder, talc, and bentonite.

[0025] Preferably, the filler is a mixture of calcium carbonate and kaolin in a mass ratio of (1-14):1.

[0026] Preferably, the calcium carbonate is colloidal calcium carbonate with an average mesh size of 2000-5000 mesh, such as Guangxi Zhechuang Chemical Co., Ltd., CAS: 471-34, with an average mesh size of 3000 mesh.

[0027] Preferably, the kaolin has an average mesh size of 200-500 mesh, for example, it is purchased from Lingshou County Baiyi Mineral Products Processing Plant and has an average mesh size of 325 mesh.

[0028] In this application, by controlling the resin components to be acrylic resin and PVC resin, and with the help of fillers and reinforcing agents, the annular plate has good wear resistance, high mechanical strength, and can be used for a long time. PVC resin has good wear resistance and chemical corrosion resistance, but poor impact resistance, is relatively brittle, and has poor toughness. The annular plate must have good toughness and abrasion resistance. The applicant added a small amount of acrylic resin, and with the help of reinforcing agents and fillers, improved its toughness and wear resistance, resulting in a better product experience and longer service life. The applicant believes that the possible reason is that the different particle sizes of silica, calcium carbonate, and kaolin continuously collide in the system, resulting in better system dispersion. The uniformly dispersed aminoacrylic resin preferentially forms a dense film on the surface of the composite material, making the material surface smoother and reducing the friction with the main tube.

[0029] Preferably, the stabilizer is selected from one or more of calcium-zinc stabilizers, barium-zinc stabilizers, and organotin stabilizers.

[0030] Preferably, the stabilizer is a barium-zinc stabilizer.

[0031] Preferably, the processing aids include, but are not limited to, one or more of antioxidant 1010, antioxidant 1076, triphenyl ester, and phenylalkyl phosphite.

[0032] Preferably, the processing aid is antioxidant 1076.

[0033] Preferably, the method for preparing the annular plate includes the following steps: (1) mixing the raw materials according to the weight parts of the constituent raw materials; (2) placing the mixed raw materials into a high-speed mixer and stirring at a temperature of 120-150℃ for 10-35 minutes; (3) extruding and granulating the stirred raw materials through a twin-screw extruder to obtain the final product.

[0034] The above technical solution has the following advantages or beneficial effects:

[0035] 1. By incorporating an adjustment ring, when the guide strip passes through the main tube and branch tubes to the area requiring nasal cavity dilation, the doctor delivers saline solution from the inlet to the branch tube via the outer lumen of the main tube. The saline solution then flows through the branch tube into the balloon, causing it to inflate. During this process, rotating the adjustment ring causes the slider to slide within the groove towards the locking block, gradually reducing the size of the ring formed by the evenly distributed annular plates. This causes the main tube to contract, controlling the speed at which saline solution enters the balloon and thus controlling the balloon's inflation size. This avoids the problem of difficulty in controlling the balloon's shape and inflation size when administering fluid to the balloon of a sinus balloon catheter outside the nasal cavity.

[0036] 2. By incorporating elastic elements, the annular plates are connected together. Rotating the adjusting ring causes the slider to slide towards the locking block, causing the annular plates to contract and the main tube to contract, thus controlling the speed at which saline enters the balloon. Due to the elasticity of the elastic elements, the arc formed by the annular plates can be enlarged and contracted according to specific needs. Therefore, the adjusting ring and its internal components can be removed from the main tube and used on other medical devices of the same type, demonstrating the practicality of the device.

[0037] 3. By controlling the resin composition to be acrylic resin and PVC resin, and with the help of fillers and reinforcing agents, the ring plate has good wear resistance, high mechanical strength, and can be used for a long time. Attached Figure Description

[0038] Embodiments of the invention will be described more fully with reference to the accompanying drawings. However, the drawings are for illustration and explanation only and do not constitute a limitation on the scope of the invention.

[0039] Figure 1 This is a schematic diagram of the main body of a shape-controllable sinus balloon catheter proposed in this invention;

[0040] Figure 2This is a schematic diagram of the adjustment ring assembly in a shape-controllable sinus balloon catheter proposed in this invention.

[0041] Figure 3 This is a schematic diagram of the annular plate assembly in a shape-controllable sinus balloon catheter proposed in this invention.

[0042] Figure 4 This is a cross-sectional view of a shape-controllable sinus balloon catheter adjustment ring proposed in this invention;

[0043] The above-mentioned reference numerals indicate: 1. Main pipe; 2. Adjusting ring; 3. Elastic element; 4. Diverter; 5. Diverter port; 6. Branch pipe; 7. Balloon; 8. Inlet; 9. Inlet of fluid; 10. Guide bar inlet; 11. Annular plate; 12. Locking block; 13. Slider; 14. Groove. Detailed Implementation

[0044] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0045] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other.

[0046] The present invention will be further described below with reference to the accompanying drawings and specific embodiments, but this is not intended to limit the scope of the invention.

[0047] Example 1

[0048] Reference Figure 1-4A shape-controllable sinus balloon catheter includes a main tube 1, an adjusting ring 2, and an elastic element 3. One end of the main tube 1 has a guide strip inlet 10, a fluid inlet 9 on one side of the guide strip inlet 10, and inlets 8 on both sides of the fluid inlet 9. The end of the main tube 1 away from the guide strip inlet 10 has a branch fluid 4, a branch outlet 5 on the side of the branch fluid 4 away from the main tube 1, and a branch tube 6 on the side of the branch outlet 5 away from the branch fluid 4. A balloon 7 is located at the end of the branch tube 6 away from the branch outlet 5. A slider 13 is located inside the adjusting ring 2, and an annular plate 11 is located at the end of the slider 13 away from the adjusting ring 2. A groove 14 is formed on the side of the annular plate 11 near the adjusting ring 2. The elastic element 3 is located on both sides of the annular plate 11. By setting the adjusting ring 2, when the guide strip… When the guide strip inlet 10 passes through the main tube 1 and branch tube 6 to reach the area requiring nasal cavity dilation, the doctor delivers saline solution from the inlet 8 through the outer cavity of the main tube 1 to the shunt 4. The saline solution flows through the shunt 5 to the branch tube 6 and then into the balloon 7, causing the balloon 7 to inflate. During this process, by rotating the adjusting ring 2, the adjusting ring 2 drives the slider 13 to slide within the groove 14 towards the locking block 12, causing the evenly distributed annular plates 11 to gradually decrease in size. This causes the main tube 1 to contract, controlling the speed at which the saline solution enters the balloon 7, thus controlling the size of the balloon 7's inflation. This avoids the problem of difficulty in controlling the shape and size of the balloon 7 when administering fluid to the balloon 7 of the sinus balloon catheter outside the nasal cavity.

[0049] Furthermore, the guide bar inlet 10 is threaded to the inlet fluid 9, the inlet fluid 9 is threaded to the inlet port 8, the inlet fluid 9 is threaded to the main tube 1, and the distributor fluid 4 is threaded to the end of the main tube 1 away from the inlet fluid 9. The main tube 1 is divided into inner and outer layers. The inner layer of the main tube 1 is used to accommodate the guide bar, and the outer layer of the main tube 1 is used to deliver physiological saline from the inlet fluid 9.

[0050] Furthermore, the diversion ports 5 are symmetrically distributed. The diversion ports 5 are fixedly connected to the diversion fluid 4. The branch pipe 6 is threadedly connected to the diversion port 5. The end of the branch pipe 6 away from the diversion port 5 is threadedly connected to the balloon 7. The diversion fluid 4 is supported by an environmentally friendly antibacterial material. The branch pipe 6 and the balloon 7 can be removed for disinfection, realizing the multiple recycling of the branch pipe 6 and the balloon 7.

[0051] Furthermore, the adjusting ring 2 is sleeved on the outside of the main tube 1, the slider 13 is evenly distributed, the slider 13 is fixedly connected to the adjusting ring 2, and the adjusting ring 2 drives the slider 13 to slide in the groove 14 toward the locking block 12, so that the ring formed by the evenly distributed annular plate 11 gradually decreases in size.

[0052] Furthermore, the end of the slider 13 away from the adjusting ring 2 is connected to the annular plate 11 through the groove 14. A locking block 12 is provided on the side of the groove 14 away from the slider 13. The locking block 12 is used to prevent the adjusting ring 2 from being rotated excessively and causing the slider 13 to slide out of the groove 14.

[0053] Furthermore, the annular plate 11 is evenly distributed and located on the outer wall of the main tube 1. The groove 14 is an inclined arc shape. The locking block 12 is located on the groove 14 and is fixedly connected to the annular plate 11. The groove 14 is an arc-shaped sliding groove with one end deep and the other end shallow. When the slider 13 slides towards the shallow end, the annular plate 11 is subjected to a force towards the center of the main tube 1, the elastic element 3 contracts, and the arc formed by the annular plate 11 becomes smaller.

[0054] Furthermore, the elastic element 3 is evenly distributed and is fixedly connected to the annular plate 11. The annular plate 11 is connected together through the elastic element 3. Due to the extensibility of the elastic element 3, the arc formed by the annular plate 11 can be enlarged and contracted according to specific needs.

[0055] Working principle: When using this device, the guide strip is passed through the guide strip inlet 10, through the main tube 1 and the branch tube 6, to the area where nasal cavity dilation is required. After determining the position, saline solution is delivered from the inlet 8 through the outer cavity of the main tube 1 to the branch tube 4. The saline solution flows through the branch tube 6 through the branch tube 5 and into the balloon 7, causing the balloon 7 to inflate. During this process, by rotating the adjusting ring 2, the adjusting ring 2 drives the slider 13 to slide in the groove 14 towards the locking block 12, so that the ring formed by the evenly distributed annular plate 11 gradually decreases, thereby causing the main tube 1 to contract and controlling the speed at which the saline solution enters the balloon 7, thus achieving the effect of controlling the inflation size of the balloon 7.

[0056] The raw materials for preparing the annular plate, by weight, include: 88 parts resin, 18 parts plasticizer, 5 parts reinforcing agent, 1.5 parts lubricant, 8 parts filler, 1.5 parts stabilizer, and 0.5 parts processing aid.

[0057] The resin is acrylic resin and PVC resin in a mass ratio of 1:25.

[0058] The acrylic resin is an amino acrylic resin, purchased from Changzhou Houding Chemical Co., Ltd., model HD-1024.

[0059] The PVC resin was purchased from Hebei Suhaote Chemical Co., Ltd., and the type is SG5 with an average degree of polymerization of 1000-1100.

[0060] The plasticizer is triethyl citrate and polypropylene sebate in a mass ratio of 6:1.

[0061] The reinforcing agent is fumed silica, purchased from Hubei Huifu Nanomaterials Co., Ltd., model number HB-151.

[0062] The lubricant is white oil, purchased from Jining Yuandong Petrochemical Co., Ltd., and its grade is 32#.

[0063] The filler is a mixture of calcium carbonate and kaolin in a mass ratio of 11:1.

[0064] The calcium carbonate in question is colloidal calcium carbonate, purchased from Guangxi Zhechuang Chemical Co., Ltd., CAS: 471-34, with an average mesh size of 3000 mesh.

[0065] The kaolin was purchased from Baiyi Mineral Products Processing Plant in Lingshou County, with an average mesh size of 325 mesh.

[0066] The stabilizer is a barium-zinc stabilizer, purchased from Wuxi Kewen Chemical Co., Ltd., model BZ-80.

[0067] The processing aid is antioxidant 1076.

[0068] The method for preparing the annular plate is as follows: (1) Mix the raw materials according to the weight parts of the constituent raw materials; (2) Put the mixed raw materials into a high-speed mixer and stir at 150°C for 12 minutes; (3) Extrude and granulate the stirred raw materials through a twin-screw extruder to obtain the final product.

[0069] Example 2

[0070] The specific implementation method of this embodiment is the same as that of Embodiment 1, except that the reinforcing agent is carbon black N330, which was purchased from Changzhou Lehuan Trading Co., Ltd., item number 2018-88.

[0071] Example 3

[0072] The specific implementation method of this embodiment is the same as that of embodiment 1, except that the resin is only PVC resin.

[0073] Example 4

[0074] The specific implementation method of this embodiment is the same as that of Embodiment 1, except that the PVC resin is purchased from Qilu Petrochemical, the model is polyvinyl chloride S-700, and the average degree of polymerization is 700.

[0075] Example 5

[0076] The specific implementation method of this embodiment is the same as that of Embodiment 1, except that the acrylic resin is purchased from Changzhou Sisai New Material Technology Co., Ltd., and the model is: hydroxy acrylic resin 838A.

[0077] Performance testing

[0078] 1. Tensile strength and elongation at break: Sample preparation and appearance inspection shall be carried out in accordance with GB1039. The tensile strength and elongation at break shall be tested in accordance with GB / T 1040-1992 "Test Method for Tensile Properties of Plastics"; the test shall be carried out using a SANS CMT7503 electronic universal testing machine at a speed of 10 mm / min.

[0079] 2. Impact strength: The impact strength of the materials in Examples 1-3 is specified in GB / T 1043.1-2008.

[0080]

[0081]

Claims

1. A shape-controllable sinus balloon catheter, characterized in that: The system includes a main tube (1), an adjusting ring (2), and an elastic element (3). One end of the main tube (1) is provided with a guide bar inlet (10). A fluid inlet (9) is provided on one side of the guide bar inlet (10). Inlet ports (8) are provided on both sides of the fluid inlet (9). A fluid divider (4) is provided at the end of the main tube (1) away from the guide bar inlet (10). A flow divider port (5) is provided on the side of the flow divider (4) away from the main tube (1). A branch tube (6) is provided on the side of the flow divider port (5) away from the flow divider (4). A balloon (7) is provided at the end of the branch tube (6) away from the flow divider port (5). A slider (13) is provided inside the adjusting ring (2). An annular plate (11) is provided at the end of the slider (13) away from the adjusting ring (2). A groove (14) is provided on the side of the annular plate (11) near the adjusting ring (2). The elastic element (3) is located on both sides of the annular plate (11). The guide bar inlet (10) is threaded to the inlet fluid (9), the inlet fluid (9) is threaded to the inlet port (8), the inlet fluid (9) is threaded to the main pipe (1), and the distributor fluid (4) is threaded to the end of the main pipe (1) away from the inlet fluid (9); The adjusting ring (2) is sleeved on the outside of the main tube (1), the sliders (13) are evenly distributed, and the sliders (13) are fixedly connected to the adjusting ring (2); The annular plate (11) is evenly distributed and located on the outer wall of the main tube (1). The groove (14) is an inclined arc shape, and the locking block (12) is located on the groove (14) and fixedly connected to the annular plate (11). The raw materials for preparing the annular plate, by weight, include: 70-120 parts resin, 10-25 parts plasticizer, 2-10 parts reinforcing agent, 0.5-3 parts lubricant, 3-15 parts filler, 0.2-4 parts stabilizer, and 0.1-2 parts processing aid; The resin is selected from one or more of acrylic resin, epoxy resin, PVC resin, phenolic resin, and PI resin.

2. The shape-controllable sinus balloon catheter according to claim 1, characterized in that: The diversion ports (5) are symmetrically distributed. The diversion ports (5) are fixedly connected to the diversion fluid (4). The branch pipe (6) is threadedly connected to the diversion ports (5). The end of the branch pipe (6) away from the diversion ports (5) is threadedly connected to the balloon (7).

3. The shape-controllable sinus balloon catheter according to claim 1, characterized in that: The end of the slider (13) away from the adjusting ring (2) is connected to the annular plate (11) through the groove (14), and a locking block (12) is provided on the side of the groove (14) away from the slider (13).

4. The shape-controllable sinus balloon catheter according to claim 1, characterized in that: The elastic element (3) is uniformly distributed and is fixedly connected to the annular plate (11).

5. The shape-controllable sinus balloon catheter according to claim 1, characterized in that: The plasticizer is selected from one or more of the following: triethyl citrate, tributyl acetyl citrate, tri-n-hexyl citrate, tri(2-propylheptyl) citrate, polypropylene sebacate, trioctyl trimellitate, tri(n-octyl-n-decyl) trimellitate, epoxidized soybean oil, epoxidized fatty acid butyl ester, epoxidized fatty acid octyl ester, and dioctyl tetrahydrophthalate.

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