An inner ear diagnostic and treatment robot and method of use

Abstract

The application discloses an inner ear diagnosis and treatment robot and a use method. The inner ear diagnosis and treatment robot comprises: a shapeable hose, the outer diameter of the hose is smaller than the inner diameter of a natural cavity, and at least one through operation channel is arranged in the hose; a continuum is arranged in the hose and can be stretched out of the hose from the front end of the hose; a puncture assembly comprises a puncture needle, a liquid storage cavity and a flexible pipeline which are sequentially communicated from the front end to the rear end; a stabilizing device is arranged outside the hose and is used for fixing the hose in the natural cavity, so that the hose does not slide relative to the natural cavity; and a control system is used for controlling the movement of the hose, the continuum and the puncture assembly. The inner ear diagnosis and treatment robot can effectively and accurately realize sampling analysis diagnosis and local drug treatment, and improves the diagnosis and treatment effect of inner ear diseases.

Description

Technical Field

[0001] This invention relates to the field of robotics, specifically to an inner ear diagnostic robot and its usage method. Background Technology

[0002] Pathological conditions of the inner ear may be accompanied by changes in characteristic biomarkers, requiring lymph fluid sampling to determine the pathological state of the inner ear. Currently, there is a lack of widely available minimally invasive lymph fluid sampling methods in clinical practice. Lymph fluid sampling is only performed during surgery in some patients, which lacks universality, keeping research on inner ear biomarkers under pathological conditions at the animal model stage.

[0003] Meanwhile, the presence of the blood-labyrinthine barrier makes it difficult to maintain effective drug concentrations in the inner ear through systemic administration. Commonly used middle ear tympanic cavity administration also has the limitation of uncertain effective concentrations. Techniques such as inner ear injection and microcatheter administration have extremely high operational requirements and are still mainly in the preclinical stage. Summary of the Invention

[0004] The purpose of this invention is to provide an effective, precise, and minimally invasive inner ear diagnostic and treatment device that can be used through natural cavities to achieve sampling analysis and diagnosis as well as local drug treatment, thereby improving the diagnosis and treatment of inner ear diseases.

[0005] To achieve the above objectives, the present invention provides an inner ear diagnostic and treatment robot, comprising:

[0006] A malleable flexible tube, wherein the outer diameter of the flexible tube is smaller than the inner diameter of the natural cavity, and the flexible tube has at least one through-operation channel inside;

[0007] A continuous body, disposed inside the hose, which can extend out of the hose from the front end of the hose;

[0008] The puncture assembly includes a puncture needle, a fluid reservoir, and a flexible tube connected sequentially from the front end to the rear end. In use, the puncture assembly is placed inside the operating channel, and the puncture needle extends out of the operating channel from the front end of the continuum.

[0009] A stabilizing device, located outside the hose, is used to fix the hose within the natural cavity, preventing the hose from sliding relative to the natural cavity.

[0010] A control system for controlling the movement of the hose, the continuum, and the puncture assembly.

[0011] Optionally, the natural cavity is the external auditory canal, and the stabilizing device is a plurality of balloons. Gas or liquid is injected into each balloon to inflate the balloon and support the tubing to remain stable within the external auditory canal.

[0012] Optionally, the balloon is connected to the outer surface of the hose, and the distance between any two adjacent balloons in the circumferential direction of the hose is no greater than half the circumference of the hose.

[0013] Optionally, the stabilizing device is a blocking member near the rear end of the hose, the size of which is larger than the inner diameter of the natural cavity.

[0014] Optionally, the front end of the puncture needle is a sharp point, and the puncture needle is provided with a sampling channel communicating with the liquid storage chamber.

[0015] Optionally, an air pump is connected to the rear end of the flexible tube, and the liquid storage chamber is pre-filled with medication. The air pump injects the medication into the front end of the puncture needle through the sampling channel; or,

[0016] The rear end of the flexible tube is connected to a negative pressure device, which draws the liquid from the sampling channel of the puncture needle into the storage chamber.

[0017] Optionally, the flexible tube contains optical fibers.

[0018] Optionally, the flexible tube contains an imaging system passage.

[0019] Optionally, the control system controls the movement of the continuum and / or the puncture needle tip by means of line drive, magnetic drive or pneumatic drive.

[0020] The present invention also provides a method of using the above-mentioned inner ear diagnostic robot, comprising:

[0021] Step 1: Insert the tubing into the natural cavity and shape it to match the curvature of the natural cavity; use a stabilizing device to fix the tubing in place within the natural cavity to prevent relative sliding between the tubing and the natural cavity.

[0022] Step 2: Control the continuous body to extend out of the hose from the front end of the hose;

[0023] Step 3: Control the needle tip of the puncture needle to extend outside the body, and take samples or administer drugs through the puncture needle;

[0024] Step 4: Remove the tubing from the natural cavity.

[0025] The beneficial effects of this invention are as follows:

[0026] (1) The inner ear diagnostic robot of the present invention can enter the inner ear through natural cavities and tympanic membrane puncture to collect lymph fluid from the inner ear or inject drugs into the inner ear, filling the current gap in the precise diagnosis and treatment of inner ear diseases. The continuum structure of the present invention can bypass structures such as the ossicular chain to reach the round window membrane for operation, and can control the flexible movement of the puncture needle in the narrow space of the inner ear, making the operation simpler.

[0027] (2) The hose of the present invention is malleable and can adapt to the curved natural cavity structure. At the same time, the hose itself has a certain degree of hardness, providing a stable operating environment for the operating channel therein.

[0028] (3) The present invention provides a stabilizing device on the outside of the hose, which can stabilize and support the hose so that the hose will not slip out of the natural cavity or shake after reaching the appropriate position. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the structure of the human ear.

[0030] Figure 2 This is a schematic diagram of the inner ear diagnostic robot of the present invention.

[0031] Figure 3 This is another structural schematic diagram of the inner ear diagnostic robot of the present invention.

[0032] Figure 4 This is a schematic diagram of the puncture assembly structure of the present invention.

[0033] Figure 5 This is a schematic diagram of the inner ear diagnostic robot of the present invention after it has been inserted into the external auditory canal.

[0034] In the diagram, 1-soft tube, 11-operation channel, 12-optical fiber, 13-operation channel side hole, 2-continuum, 3-handheld part, 30-adjustment knob, 4-puncture assembly, 41-puncture needle, 42-liquid reservoir, 43-flexible tube, 51-balloon, 52-injection channel, A-external auditory canal, B-tympanic membrane, C-ossicular chain, D-inner ear. Detailed Implementation

[0035] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. 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.

[0036] In the description of this invention, it should be noted that the terms "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0037] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal communication between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0038] Natural cavities are naturally occurring channels in the human body that connect to the outside world. Unless otherwise specified, natural cavities in this invention include the external auditory canal and the nasal cavity. The inner ear diagnostic robot provided by this invention can enter the inner ear through either the external auditory canal or the nasal cavity.

[0039] Figure 1 This is a schematic diagram of the human ear structure. From the outside in, the ear includes the external auditory canal, tympanic membrane, ossicular chain, and inner ear, with lymph fluid located in the inner ear. The inner ear diagnostic robot provided by this invention, when entering the inner ear through the external auditory canal, sequentially passes through the external auditory canal A, the tympanic membrane B, bypasses the ossicular chain C, and enters the target location D in the inner ear to aspirate lymph fluid or administer medication to the inner ear.

[0040] like Figures 2-4 As shown, the inner ear diagnostic robot provided by the present invention includes a flexible tube 1, a continuous body 2, a puncture assembly 4, a stabilizing device, and a control system.

[0041] The flexible tube 1 is a malleable tubular structure capable of bending to a certain extent. Since the shapes of natural cavities in the human body vary, the flexible tube 1 is shaped and bent to adapt to different cavities. The outer diameter of the flexible tube 1 is smaller than the inner diameter of the natural cavity, allowing space for its movement within the cavity, enabling it to extend along the length of the cavity. The flexible tube 1 has at least one through-hole operating channel 11 for inserting the puncture component into the natural cavity. In some embodiments, the flexible tube 1 contains an optical fiber 12 for creating an opening in the tympanic membrane via a laser fiber. In some embodiments, the flexible tube 1 also contains an imaging system pathway for acquiring intraoperative images; the imaging system has an imaging resolution ≤0.02 mm.

[0042] The continuous body 2 is housed within the flexible tube 1 and extends outward from the front end of the tube 1, providing mobility for the puncture assembly. The continuous body 2 can be a structure based on self-contact configurations. By designing self-contact blocks of various sizes, the circumferential angles of each flexible segment of the continuous body 2 can be adjusted to achieve flexible and controllable robot movement in multiple angles and directions in space. The maximum adjustable angle of the continuous body 2 as a whole is not less than 90°. Optionally, the outer diameter of the continuous body 2 is ≤2.0mm.

[0043] The puncture assembly 4 includes a puncture needle 41, a fluid reservoir 42, and a flexible conduit 43 connected sequentially from front to rear. An operating channel side hole 13 is opened at the rear end of the flexible tube 1, through which the puncture assembly enters the operating channel 11. After the continuum 2 extending from the front end of the flexible tube 1 is positioned at the circular window location, the needle tip of the puncture needle 41 extends from the front end of the continuum 2. By controlling the angle and direction of the continuum 2, the puncture needle 41 can move with the continuum 2, meaning the continuum 2 provides the puncture needle 41 with greater mobility. Once the continuum 2 reaches the appropriate position, the surgical procedure is performed through the puncture needle 41.

[0044] The tip of the puncture needle 41 is a sharp point, which can optionally be beveled, conical, or polygonal. The puncture needle 41 has a through sampling channel that communicates with the fluid reservoir 42. Using the puncture assembly of this invention, both lymph fluid can be aspirated and sampled, and medication can be administered to the inner ear.

[0045] In some embodiments, when lymph fluid sampling is required, the reservoir 42 remains empty or partially empty, and the rear end of the flexible conduit 43 is connected to a negative pressure device. The circular window membrane is punctured using a puncture needle 41, and the negative pressure device is activated to aspirate the lymph fluid, allowing it to enter the reservoir 42 through the sampling channel of the puncture needle 41. After aspiration is complete, the puncture assembly is withdrawn from the operating channel 11, and the operator can remove the lymph fluid from the reservoir 42 for further testing.

[0046] In some embodiments, when medication needs to be administered to the inner ear, a liquid solution is pre-filled in the reservoir 42, and an air pump is connected to the rear end of the flexible conduit 43. The circular window membrane is punctured using a puncture needle 41, and the air pump is activated, allowing the liquid solution in the reservoir 42 to be delivered into the inner ear through the sampling channel of the puncture needle 41. After medication administration, the puncture assembly is withdrawn from the operating channel 11. In this embodiment, the location of the reservoir 42 is not limited to between the puncture needle 41 and the flexible conduit 43; the reservoir 42 can be located at any position on the flexible conduit 43.

[0047] A stabilizing device is located outside the flexible tube 1 to secure it within the natural auditory canal, preventing relative sliding. Because the outer diameter of the flexible tube 1 is smaller than the inner diameter of the natural auditory canal, once inserted, it can easily continue into or slip out of the canal, or move around within it. This movement further affects the stability of the puncture assembly, posing risks to the procedure. The stabilizing device keeps the flexible tube 1 stably within the natural auditory canal and provides support. Preferably, the stabilizing device contains a pressure feedback contact to provide real-time feedback on micro-displacements between the stabilizing device and the natural auditory canal.

[0048] In some embodiments, the stabilizing device is a stop near the rear end of the tubing 1, the size of which is larger than the inner diameter of the natural auditory canal. For example, when the tubing 1 is inserted into the external auditory canal, the stop can be earplug-shaped; after the tubing 1 reaches the appropriate position, the earplug-shaped stop is pushed to the opening of the external auditory canal.

[0049] With the obstruction in place, the insertion depth of the tube in the external auditory canal is fixed to ensure that the tube 1 cannot extend further into the external auditory canal during the procedure. When the tube 1 is inserted through the nasal cavity along the Eustachian tube, the size of the obstruction is larger than the inner diameter of the nasal cavity to ensure that the tube 1 cannot extend further into the Eustachian tube during the procedure.

[0050] In embodiments where the natural cavity is the external auditory canal, the stabilizing device consists of several balloons 51. The balloons 51 are connected to the outside of the flexible tube 1. The balloons 51 are made of an elastic material such as rubber. Initially, the balloons 51 are not filled with any substance; they adhere to the outside of the flexible tube 1 and are inserted into the external auditory canal along with the flexible tube 1. At this time, the balloons 51 do not obstruct the forward or backward movement of the flexible tube 1 within the external auditory canal. After the flexible tube 1 reaches the appropriate position, gas or liquid is injected into each balloon 51, causing it to inflate. For example, a long, narrow injection channel 52 can be connected to each balloon 51 facing outwards from the ear canal. Each injection channel 52 extends beyond the ear canal, or several injection channels 52 converge into a single main injection channel extending beyond the ear canal, through which gas or liquid is injected into the balloon 51. After the balloon 51 inflates, part of its outer surface connects to the tubing 1, and part of its outer surface abuts against the inner wall of the external auditory canal, supporting the tubing 1 to remain stable within the external auditory canal. This prevents the tubing 1 from sliding relative to the external auditory canal, continuing to extend into the external auditory canal, or slipping out of the external auditory canal, and also prevents it from wobbling within the external auditory canal, thus affecting the stability and accuracy of the surgical procedure. Preferably, the distance between any two balloons 51 that are adjacent upwards around the circumference of the tubing 1 is no greater than half the circumference of the tubing 1. Since the external auditory canal has a certain length, the balloons 51 can be positioned at different locations along the length of the tubing 1. Two balloons 51 that are adjacent upwards around the circumference of the tubing 1 may not be located on the same circumference of the tubing 1, that is, the distance between the two balloons 51 in the length direction of the tubing 1 is greater than 0, but the distance between the two balloons 51 in the circumference of the tubing 1 cannot be too large. For example, in an embodiment with only two balloons 51, the two balloons 51 are evenly distributed in the circumference of the tubing 1, and the distance between them is equal to half the circumference of the tubing 1. This ensures that there is at least one supporting balloon 51 on any half-circumference of the tubing 1, so that the tubing 1 does not sway in the external auditory canal.

[0051] The control system controls the movement of the tubing 1, the continuous body 2, and the puncture assembly. The control system controls the movement of the continuous body 2 via wire drive, magnetic drive, or pneumatic operation. The inner ear diagnostic robot of this invention may further include a handheld part 3, which has an adjustment knob 30 for controlling the rotation of the continuous body 2; furthermore, the handheld part 3 can be connected to an imaging system via a cable. An operating channel side hole 13 is located at the junction of the handheld part 3 and the tubing 1.

[0052] In some embodiments, any part that may come into contact with the human body, such as the tubing 1, the stabilizing device, and the puncture needle 41, is equipped with a force feedback device to detect posture and physical interference with structures such as the ear canal and tympanic membrane. The pressure sensor in the force feedback device has a resolution of less than 0.025 N / mm.

[0053] Methods for aspirating lymph fluid or administering medication to the inner ear using the inner ear diagnostic robot provided by this invention include:

[0054] Step 1: Insert the tubing 1 into the natural cavity and aim at the tympanic membrane puncture site.

[0055] If the curvature of the natural cavity affects aiming, the hose 1 is shaped to match the curvature of the natural cavity. The hose 1 can be shaped manually or through a programmable control system. The hose 1 is then fixed inside the natural cavity by a stabilizing device to prevent relative sliding between the hose 1 and the natural cavity.

[0056] In embodiments where the stabilizing device is a blocking element, the blocking element is fixed at the entrance of the natural cavity; in embodiments where the blocking element is a balloon, the balloon is inflated or filled with water to complete the fixation of the tubing 1. Optionally, the balloons at different positions are inflated or filled with water asymmetrically.

[0057] Step 2: Control the continuum 2 to extend from the front end of the tubing 1 and enter the middle ear to locate the round window.

[0058] Optionally, before performing step two, the method further includes creating an opening in the tympanic membrane using a laser fiber within the flexible tube 1 of the present invention. Alternatively, the tympanic membrane can be pre-opened using other existing techniques before performing step one, inserting the flexible tube 1 into the natural ear canal. A schematic diagram of the inner ear treatment robot of the present invention after insertion into the external auditory canal is shown below. Figure 5 As shown.

[0059] Step 3: After the circular window position is determined, the puncture assembly is placed into the operation channel 11, and the tip of the puncture needle 41 is controlled to extend out of the continuous body 2. The puncture needle 41 is then used to puncture the circular window membrane.

[0060] If an inner ear diagnostic robot is used to aspirate lymph fluid from the inner ear, the reservoir 42 remains empty or partially empty, and the rear end of the flexible conduit 43 is connected to a negative pressure device. The negative pressure device is activated to aspirate the lymph fluid, allowing it to enter the reservoir 42 through the sampling channel of the puncture needle 41. After aspiration is complete, the puncture assembly is withdrawn from the operating channel 11, and the operator can remove the lymph fluid from the reservoir 42 for further testing.

[0061] If an inner ear diagnostic robot is used to administer medication to the inner ear, the medication solution is pre-filled in the reservoir 42, and the rear end of the flexible tube 43 is connected to an air pump. The air pump is then turned on, allowing the medication solution in the reservoir 42 to be delivered into the inner ear through the sampling channel of the puncture needle 41.

[0062] Step four: Remove the puncture assembly from the operating channel 11, and then remove the tubing 1 from the natural cavity.

[0063] Optionally, before performing step four, a step of infusing biological glue into the surgical area is also included. Specifically, this includes first removing the puncture assembly from the operating channel 11, then inserting a new puncture assembly into the operating channel 11, aligning the puncture needle 41 with the location such as the round window or tympanic membrane that was damaged in the previous step, pre-filling the reservoir 42 of the puncture assembly with biological glue, connecting the rear end of the flexible tube 43 to an air pump, and infusing the biological glue in the reservoir 42 into the surgical area to ensure good healing of the round window, tympanic membrane, and other locations.

[0064] In summary, this invention discloses an inner ear diagnostic robot and its method of use. The inner ear diagnostic robot includes: a malleable flexible tube, a continuous body disposed within the flexible tube, a puncture component, a stabilization device, and a control system. This inner ear diagnostic robot can effectively and accurately perform sampling analysis and diagnosis, as well as local drug treatment, thereby improving the diagnostic and treatment outcomes of inner ear diseases.

[0065] Although the present invention has been described in detail through the preferred embodiments above, it should be understood that the above description should not be considered as a limitation of the present invention. Various modifications and substitutions to the present invention will be apparent to those skilled in the art after reading the above description. Therefore, the scope of protection of the present invention should be defined by the appended claims.

Claims

1. An inner ear diagnostic robot, characterized in that, include: A malleable flexible tube, wherein the outer diameter of the flexible tube is smaller than the inner diameter of the natural cavity, and the flexible tube has at least one through-operation channel inside; The natural cavity is the external auditory canal; A continuum, located inside the flexible tube, can extend from the front end of the tube to enter the middle ear and locate the circular window; the maximum adjustable angle of the continuum as a whole is not less than 90°; the continuum is a structure based on self-contact and other configurations, and by designing self-contact blocks of various sizes, the circumferential angle of each flexible segment of the continuum can be adjusted to achieve flexible and controllable robot movement in multiple angles and directions in space; The puncture assembly includes a puncture needle, a fluid reservoir, and a flexible tube connected sequentially from the front end to the rear end. In use, the puncture assembly is placed in the operating channel, the puncture needle extends out of the operating channel from the front end of the continuous body, the puncture needle moves with the continuous body, and the continuous body provides the puncture needle with a degree of mobility. A stabilizing device, located outside the hose, is used to fix the hose within the natural cavity, preventing the hose from sliding relative to the natural cavity. The stabilizing device consists of several balloons. Gas or liquid is injected into each balloon to inflate it and support the tubing to remain stable within the external auditory canal. The balloons are connected to the outer surface of the tubing, and the distance between any two adjacent balloons in the circumferential direction of the tubing is no greater than half the circumference of the tubing. A control system for controlling the movement of the hose, the continuum, and the puncture assembly.

2. The inner ear diagnostic robot as described in claim 1, characterized in that, The puncture needle has a pointed tip at its front end, and a sampling channel communicating with the liquid storage chamber is provided inside the puncture needle.

3. The inner ear diagnostic robot as described in claim 2, characterized in that, The flexible tube is connected to an air pump at its rear end. The reservoir is pre-filled with medication. The air pump injects the medication through the sampling channel of the puncture needle into the distal end; or... The rear end of the flexible tube is connected to a negative pressure device, which draws the liquid from the sampling channel of the puncture needle into the storage chamber.

4. The inner ear diagnostic robot as described in claim 1, characterized in that, The flexible tube contains optical fibers.

5. The inner ear diagnostic robot as described in claim 1, characterized in that, The flexible tube contains an imaging system passage.

6. The inner ear diagnostic robot as described in claim 1, characterized in that, The control system controls the movement of the continuum and / or the puncture needle tip through line drive, magnetic drive or pneumatic means.

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