Force-sensing microinstrument

Abstract

The present invention relates to the technical field of medical devices, and provides a force-sensing microinstrument, which includes a housing and a drug injection assembly. The housing includes a drug injection needle tube, a first optical fiber, and a second optical fiber; a bent needle tip is provided at the distal end of the drug injection needle tube; the first optical fiber and the second optical fiber are distributed along the length direction of the drug injection needle tube on the outer periphery of the drug injection needle tube and are encapsulated in the housing; the first optical fiber and the second optical fiber are Bragg optical fibers, both are provided with grating regions, and at least one of the two is provided with a plurality of the grating regions at intervals, and the grating regions are used to sense the radial force received by the drug injection needle tube. This force-sensing microinstrument can detect the puncture force of the drug injection needle tube on blood vessels only through two Bragg optical fibers, reducing the outer diameter of the force-sensing micro needle, enabling it to fit a smaller-sized trocar, thereby reducing the damage to the sclera during retinal vein injection operations and reducing the risks of bleeding, hyperplasia of the tissue around the incision, and retinal traction.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a force-sensing microscopic instrument. Background Art

[0002] Retinal vein occlusion is the second most common retinal vascular disease. An effective treatment method is to directly inject a sufficient dose of thrombolytic agent into the occluded retinal vein. Currently, the common clinical practice is to puncture the sclera with a trocar to establish a channel for the instrument to enter the eye, illuminate the intraocular field through a fiber optic lamp, and at the same time insert an injection needle into the eye through this channel to puncture and inject medicine into the blood vessels at the fundus of the eye. Since the diameter of the retinal vein blood vessels is only dozens of micrometers, double puncture is extremely easy to cause, resulting in damage to the human eye. Therefore, accurately detecting the moment of retinal vein puncture is one of the necessary conditions to ensure the safe progress of this operation.

[0003] In the prior art, the methods for detecting the moment of retinal vein puncture include the detection method based on OCT images and the detection method based on force. Among them, the detection method based on force is to arrange Bragg optical fibers on the retinal vein injection needle, and detect the puncture force through the Bragg optical fibers. In the related art, three Bragg optical fibers are arranged around the injection needle tube at an angle of 120° to each other to form a force-sensing micro needle, which can sense the two-dimensional force along the radial direction of the needle tube.

[0004] However, since it is necessary to ensure that the force-sensing micro needle has a certain stiffness, the injection needle tube generally uses a stainless steel tube, and due to the current limitations of the force optical fiber process, the size of the force-sensing micro needle is relatively large. Therefore, in clinical applications, a trocar with a larger inner diameter can only be used to establish a channel for the force-sensing micro needle to enter the sclera, or directly make an incision in the sclera, but both will cause a larger wound to the sclera, and there will be risks of bleeding, tissue hyperplasia around the incision, and retinal traction. Summary of the Invention

[0005] The present invention provides a force-sensing microscopic instrument to solve the problem that the diameter of the force-sensing micro needle used for retinal vein injection in the prior art is relatively large, resulting in a relatively large wound to the sclera clinically.

[0006] The present invention provides a force-sensing microscopic instrument, including:

[0007] A housing;

[0008] The drug injection assembly includes a drug injection needle, a first optical fiber and a second optical fiber; a bent needle is provided at the distal end of the drug injection needle; the first optical fiber and the second optical fiber are distributed on the outer circumference of the drug injection needle along the length direction of the drug injection needle and are encapsulated in the outer shell; the first optical fiber and the second optical fiber are Bragg fibers, both of which are provided with grating areas, and at least one of the two is provided with multiple grating areas at intervals, and the grating areas are used to sense the radial force applied to the drug injection needle.

[0009] According to a force sensing microscopic instrument provided by the present invention, the first optical fiber and the second optical fiber are both provided with two grating regions spaced apart from each other, and the first optical fiber and the second optical fiber have the same structure.

[0010] According to a force-sensing microscopic instrument provided by the present invention, the injection component also includes: a potting part, the potting part is provided with a first potting channel, a second potting channel and a third potting channel, the first optical fiber is arranged in the first potting channel, the second optical fiber is arranged in the second potting channel, and the injection needle is arranged in the third potting channel.

[0011] A force sensing microscopic instrument according to the present invention further comprises:

[0012] The sleeve comprises a tube seat and a straight tube, wherein the tube seat is connected to one end of the shell close to the bent needle, one end of the straight tube is penetrated through the tube seat, the potting part is penetrated through the straight tube, and the grating area is located outside the straight tube.

[0013] According to a force sensing microscopic instrument provided by the present invention, the injection needle tube comprises: a drug delivery tube and an injection needle; one end of the injection needle is inserted into the drug delivery tube and sealedly connected to the drug delivery tube, and the bent needle head is formed at one end of the injection needle away from the drug delivery tube.

[0014] According to a force sensing microscopic instrument provided by the present invention, the drug delivery tube is a nickel-titanium alloy tube.

[0015] A force sensing microscopic instrument according to the present invention further comprises:

[0016] The drug delivery assembly includes a connector assembly, a first pressure extension tube and a transfer tube, wherein one end of the first pressure extension tube is connected to the connector assembly, and the other end is connected to the injection needle through the transfer tube, and the connector assembly is connected to one end of the shell away from the bent needle.

[0017] According to a force sensing microscopic instrument provided by the present invention, the drug delivery assembly further includes: a second pressure extension tube and a three-way valve, one end of the second pressure extension tube is connected to the three-way valve, and the other end is detachably connected to the connector assembly.

[0018] A force-sensing micro instrument provided by the present invention, the adapter tube includes: a first tube body and a second tube body, the first pressure extension tube is sleeved at one end of the first tube body, the other end of the first tube body is sleeved at one end of the second tube body, and the end of the drug injection needle tube away from the bent needle tip is inserted into the other end of the second tube body.

[0019] A force-sensing micro instrument provided by the present invention, the second tube body is provided with a connected first channel and a second channel, the diameter of the second channel is larger than that of the first channel, and the drug injection needle tube is inserted into the first channel.

[0020] For the force-sensing micro instrument provided by the present invention, by arranging a first optical fiber and a second optical fiber on the outer periphery of the drug injection needle tube, both the first optical fiber and the second optical fiber are Bragg optical fibers, and at least one of them is provided with a plurality of grating regions at intervals, so that the first optical fiber and the second optical fiber have at least three grating regions in total. According to the mapping relationship between the radial force received by the at least three grating regions and the reflection wavelength change rate, the two-dimensional radial force received by the drug injection needle tube can be solved, so that the puncture force of the needle tip can be accurately obtained, and the accurate detection of the moment of retinal vein puncture can be realized. This force-sensing micro instrument can detect the puncture force of the drug injection needle tube on the blood vessel only through two Bragg optical fibers, reduce the outer diameter of the force-sensing micro needle, and thus be adapted to a smaller-sized trocar, thereby reducing the damage to the sclera during retinal vein injection operation and reducing the risks of bleeding, tissue hyperplasia around the incision, and retinal traction. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions in the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0022] Figure 1 It is a schematic diagram of the overall structure of the force-sensing micro instrument provided by the present invention.

[0023] Figure 2 It is a schematic diagram of the internal structure of the force-sensing micro instrument provided by the present invention.

[0024] Figure 3 It is a schematic diagram of a partial structure of the drug injection assembly of the force-sensing micro instrument provided by the present invention.

[0025] Figure 4 is Figure 3 The cross-sectional view taken along line A-A in

[0026] Figure 5It is an exploded structural schematic diagram of the force-sensing micro instrument provided by the present invention.

[0027] Figure 6 It is an exploded structural schematic diagram of a partial structure of the force-sensing micro instrument provided by the present invention.

[0028] Figure 7 It is Figure 6 A partial enlarged view of part B circled in

[0029] Figure 8 It is Figure 6 A partial enlarged view of part C circled in

[0030] Figure 9 It is Figure 6 A partial enlarged view of part D circled in

[0031] Figure 10 It is Figure 6 A partial enlarged view of part E circled in

[0032] Figure 11 It is a cross-sectional view of the internal structure of the force-sensing micro instrument provided by the present invention.

[0033] Figure 12 It is Figure 11 A partial enlarged view of part F circled in

[0034] Figure 13 It is Figure 11 A partial enlarged view of part G circled in

[0035] Figure 14 It is Figure 11 A partial enlarged view of part H circled in

[0036] Figure 15 It is an exploded structural schematic diagram of the drug delivery component of the force-sensing micro instrument provided by the present invention.

[0037] Reference numerals:

[0038] 1. Housing; 2. Medication injection assembly; 20. Grating area; 21. First optical fiber; 211. First grating area; 212. Second grating area; 22. Second optical fiber; 221. Third grating area; 222. Fourth grating area; 23. Medication injection syringe; 231. Medication delivery tube; 232. Medication injection needle; 230. Bent needle tip; 24. Potting part; 241. First potting channel; 242. Second potting channel; 243. Third potting channel; 25. Potting body; 3. Medication delivery assembly; 31. Connector assembly; 311. First Luer connector; 312. Blade ring; 313. Split connector; 32. First pressure extension tube; 33. Adapter; 331. First tube body; 332. Second tube body; 3321. First channel; 3322. Second channel; 34. Second pressure extension tube; 35. Three-way valve; 36. Second Luer connector; 37. Third Luer connector; 4. Sleeve; 41. Tube base; 42. Straight tube; 5. Optical fiber connector. Detailed implementation manners

[0039] To make the objectives, technical solutions and advantages of the present invention clearer, the technical solutions in the present invention will be clearly and completely described below with reference to the accompanying drawings in the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present invention without creative efforts shall fall within the protection scope of the present invention.

[0040] In the description of the embodiments of the present invention, it should be noted that unless otherwise clearly specified and limited, the terms "first"... "fourth" are used for numbering product components for clear description and do not represent any substantial difference. The terms "mounted", "connected" and "coupled" should be construed broadly. For example, it may be a fixed connection, a detachable connection, or an integral connection; it may be directly connected, or indirectly connected through an intermediate medium, and it may be the internal communication of two components. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific circumstances. In addition, the meaning of "a plurality" is two or more.

[0041] The following combines Figures 1 - 15 to describe the force-sensing microinstrument of the present invention.

[0042] As Figures 1 - 4As shown in the figure, the force-sensing microsurgical instrument provided by the embodiment of the present invention includes a housing 1 and a drug injection assembly 2. The drug injection assembly 2 includes a drug injection needle tube 23, a first optical fiber 21, and a second optical fiber 22. A bent needle tip 230 is provided at the distal end of the drug injection needle tube 23. The first optical fiber 21 and the second optical fiber 22 are distributed along the length direction of the drug injection needle tube 23 on the outer periphery of the drug injection needle tube 23 and are encapsulated in the housing 1. The first optical fiber 21 and the second optical fiber 22 are Bragg optical fibers, and both are provided with grating regions 20. At least one of the two is provided with a plurality of grating regions 20 at intervals. The grating regions 20 are used to sense the radial force received by the drug injection needle tube 23.

[0043] Specifically, referring to Figure 1 , a part of the drug injection assembly 2 is located inside the housing 1. The part of the drug injection assembly 2 near its distal end extends out of the housing 1, and a bent needle tip 230 is provided at the distal end. Figure 2 is the core functional part exposed after removing the housing 1. The bent needle tip 230 can be a angled needle tip, such as Figure 3 shown in the figure where the needle tip is bent by 45°. Referring to Figure 3 and Figure 4 , the first optical fiber 21 and the second optical fiber 22 are distributed along the length direction of the drug injection needle tube 23 on the outer periphery of the drug injection needle tube 23, and the bent needle tip 230 extends relative to the first optical fiber 21 and the second optical fiber 22. The drug injection assembly 2 thus formed is a force-sensing micro needle, and its outer diameter size is jointly determined by the first optical fiber 21, the second optical fiber 22, and the drug injection needle tube 23.

[0044] In some embodiments of the present invention, as shown in Figure 7 and Figure 14 , the drug injection needle tube 23 includes a drug delivery tube 231 and a drug injection needle 232. One end of the drug injection needle 232 is inserted into the drug delivery tube 231 and is hermetically connected to the drug delivery tube 231. The bent needle tip 230 is formed at the end of the drug injection needle 232 away from the drug delivery tube 231. Specifically, the first optical fiber 21 and the second optical fiber 22 are distributed along the length direction of the drug delivery tube 231 on the outer periphery of the drug delivery tube 231. The drug injection needle 232 and the drug delivery tube 231 are adhesively fixed and sealed through a biocompatible glue.

[0045] It should be noted that the drug injection needle tube 23 can also be an integral needle tube, such as a stainless steel needle tube, which has a straight tube portion and a bent portion, and one end of the bent portion forms the bent needle tip 230. The first optical fiber 21 and the second optical fiber 22 are distributed along the length direction of the straight tube portion on the outer periphery of the straight tube portion.

[0046] In practical applications, the first optical fiber 21 and the second optical fiber 22 are respectively connected to a demodulator through fiber optic connectors 5. The demodulator inputs a beam of broadband light source into the first optical fiber 21 and the second optical fiber 22. When the light passes through the grating region 20, a part of the light passes through the grating, and another part of the light is reflected back under the action of the grating and is captured and demodulated by the demodulator to obtain the wavelength of the reflected light. Among them, the demodulator can be a component of the force-sensing microinstrument of the embodiment of the present invention.

[0047] In the application of retinal vein injection in clinical practice, first, a trocar with an inner diameter larger than that of the drug injection assembly 2 is inserted into the sclera to establish a channel, and then the drug injection assembly 2 of the force-sensing microinstrument is inserted into the eye through this channel, and the blood vessels at the fundus of the eye are punctured and injected with drugs by bending the needle tip 230. When the needle pierces the vein, the force at the moment of puncture will mutate, and the radial force received by the drug injection syringe 23 at the position corresponding to the grating region 20 will also mutate accordingly, thereby causing the wavelength of the reflected light to mutate. The demodulator can obtain the puncture force of the needle on the blood vessel according to the mapping relationship between the puncture force and the wavelength change rate. According to the magnitude of the puncture force, it can be determined whether the needle has pierced the vein to prevent secondary puncture. It should be noted that the force-sensing microinstrument provided by the embodiment of the present invention can be used not only for retinal vein puncture but also for vein puncture of other human tissues.

[0048] At least one of the first optical fiber 21 and the second optical fiber 22 is provided with a plurality of grating regions 20 at intervals, that is, the total number of the grating regions 20 on the first optical fiber 21 and the grating regions 20 on the second optical fiber 22 is at least three. For example, one grating region 20 is provided on the first optical fiber 21 and two grating regions 20 are provided on the second optical fiber 22. Or, two grating regions 20 are provided on the first optical fiber 21 and one grating region 20 is provided on the second optical fiber 22.

[0049] Optionally, the length of the grating region 20 is 0.9 - 1.1 mm, such as 1 mm. The interval between two grating regions 20 is 0.9 - 1.1 mm, such as 1 mm. In this way, it can be ensured that when performing retinal vein puncture, two grating regions 20 on the same optical fiber can enter the eye to ensure that each grating region 20 can accurately sense the force, and a sufficient interval can ensure that the demodulator can accurately demodulate the reflected wavelengths of the two grating regions 20.

[0050] In a specific embodiment of the present invention, both the first optical fiber 21 and the second optical fiber 22 are provided with two mutually spaced grating regions 20. In this way, the first optical fiber 21 and the second optical fiber 22 with the same structure can be set, that is, the same two optical fibers can be used, which is convenient for production and manufacturing. As Figure 9 shown, the first optical fiber 21 is provided with a first grating region 211 and a second grating region 212, and the second optical fiber 22 is provided with a third grating region 221 and a fourth grating region 222.

[0051] Taking the example where both the first optical fiber 21 and the second optical fiber 22 are provided with two grating regions 20, the principle of detecting the needle puncture force through the first optical fiber 21 and the second optical fiber 22 is introduced as follows:

[0052] Refer to Figure 3 and Figure 4 , the puncture force of the tip of the bent needle 230 is F, which can be decomposed into an axial force and a radial force along the axial and radial directions of the drug delivery tube 231 of the injection needle tube 23 (or the straight tube portion of the integrated injection needle tube 23). Take the A-A section, and the radial force can be decomposed into perpendicular radial forces and radial force in the X and Y directions respectively. The included angle between the second optical fiber 22 and is , and the included angle between the first optical fiber 21 and is . The distances from the tip of the needle to the centers of the four grating regions 20 are respectively denoted as .

[0053] According to the cantilever beam theory, the strain magnitudes of the grating regions 20 on the first optical fiber 21 and the second optical fiber 22 are:

[0054] (1)

[0055] where is the strain of each grating region 20, r is the distance between the central axis of the optical fiber and the central axis of the injection needle tube 23, E is the elastic modulus of the optical fiber, is the moment of inertia of the cross-section of the optical fiber in the X direction, is the moment of inertia of the cross-section of the optical fiber in the Y direction, is the distance between the center of each grating region 20 and the tip of the bent needle 230. Among them, i = {1, 2}, j = {1, 2}.

[0056] According to the formula for the change rate of the Bragg fiber grating reflection wavelength, the change rate of the wavelength of each grating region 20 can be obtained as:

[0057] (2)

[0058] where is the wavelength change amount, is the wavelength, is the temperature change constant, is the change amount of the ambient temperature; is the strain constant.

[0059] Eliminate the influence of the temperature coefficient by the differential mode method, that is, define the measured wavelength change rate as:

[0060] (3)

[0061] According to the above equations (1), (2) and (3), the radial force and The mapping relationship with the wavelength change rate:

[0062]

[0063] Among them, , .

[0064] Calibrate this constant matrix, and the mapping relationship between the wavelength change rate and the two-dimensional radial force can be established. Since the radial force and are obtained by decomposing the puncture force F. According to the parallelogram theorem of force decomposition, the mapping relationship between the wavelength change rate of the fiber optic grating and the puncture force F can be obtained. According to the wavelength change rate and this mapping relationship, the puncture force of the needle on the blood vessel can be obtained.

[0065] The force-sensing micro instrument provided by the embodiment of the present invention arranges the first optical fiber 21 and the second optical fiber 22 on the outer periphery of the injection needle tube 23. The first optical fiber 21 and the second optical fiber 22 are both Bragg optical fibers, and at least one of them is provided with a plurality of grating regions 20 at intervals, so that the first optical fiber 21 and the second optical fiber 22 have at least three grating regions 20 in total. According to the mapping relationship between the radial force received by the at least three grating regions 20 and the reflection wavelength change rate, the two-dimensional radial force received by the injection needle tube 23 can be solved, so that the puncture force of the needle tip can be accurately obtained, and the precise detection of the moment of retinal vein puncture can be realized. This force-sensing micro instrument can detect the puncture force of the injection needle tube 23 on the blood vessel only through two Bragg optical fibers, reducing the outer diameter of the force-sensing micro needle, so as to be adapted to a smaller-sized stylet, thereby reducing the damage to the sclera during retinal vein injection operation and reducing the risks of bleeding, tissue hyperplasia around the incision, and retinal traction.

[0066] As Figure 6 and Figure 8 shown, the injection assembly 2 further includes a potting part 24, and the potting part 24 is provided with a first potting channel 241, a second potting channel 242 and a third potting channel 243. The first optical fiber 21 is disposed through the first potting channel 241, the second optical fiber 22 is disposed through the second potting channel 242, and the injection needle tube 23 is disposed through the third potting channel 243. The outer diameter of the potting part 24 is the outer diameter of the force-sensing micro needle.

[0067] Specifically, the straight tube portion of the drug injection syringe 23 or the drug delivery tube 231 is combined with the first optical fiber 21 and the second optical fiber 22 through a potting process to form a potted body 25, see Figure 13 . The potted material is partially the potted portion 24. After potting, a first potted channel 241, a second potted channel 242, and a third potted channel 243 are formed. In this embodiment, the drug injection syringe 23, the first optical fiber 21, and the second optical fiber 22 are potted into one body, which can improve the relative positions of the three and the stability of the structure of the drug injection assembly 2.

[0068] As Figure 5 , Figure 11 and Figure 13 shown, the force sensing micro-instrument provided by some embodiments of the present invention further includes a sleeve 4. The sleeve 4 includes a base 41 and a straight tube 42. The base 41 is connected to one end of the housing 1 close to the bent needle tip 230, and one end of the straight tube 42 passes through the base 41. The potted portion 24 passes through the straight tube 42, and the grating region 20 is located outside the straight tube 42.

[0069] Specifically, the straight tube 42 is inserted into the base 41 and fixed by glue bonding. The straight tube 42 is sleeved outside the potted body 25 formed by potting the drug injection syringe 23, the first optical fiber 21, and the second optical fiber 22, see Figure 14 . And, the straight tube 42 does not cover the grating region 20 on the optical fiber. The drug injection assembly 2 sequentially passes through the housing 1, the base 41, and the straight tube 42. The straight tube 42 can provide structural support for the drug injection assembly 2 to make it meet sufficient stiffness.

[0070] It can be understood that when the drug injection syringe 23 is a stainless steel syringe or the drug delivery tube 231 has sufficient stiffness, the straight tube 42 may not be provided. In this case, the drug injection assembly 2 sequentially passes through the housing 1 and the base 41, and the base 41 can be used as a part of the housing 1, or the base 41 and the housing 1 are integrally formed.

[0071] In some embodiments of the present invention, the drug delivery tube 231 is a nitinol tube. The nitinol material can be used to make a thinner drug delivery tube 231. When the drug delivery tube 231 is thin enough, to make up for the problem of insufficient stiffness of the drug delivery tube 231, the straight tube 42 in the above embodiment can be provided to provide structural support for the drug injection syringe 23, the first optical fiber 21, and the second optical fiber 22.

[0072] In a specific example using a nickel-titanium alloy drug delivery tube 231, the diameter of the drug injection assembly 2 formed after potting can be made 0.4 mm, which is suitable for the cannula of the commonly used 23G specification (inner diameter about 0.6 mm) on the current market. In the prior art, three Bragg optical fibers are distributed around the outer periphery of a stainless-steel needle tube at an angle of 120° to each other, and the minimum diameter of the commonly used stainless-steel needle tube is 0.64 mm, and the diameter of the Bragg optical fiber is about 0.11 - 0.165 mm. In this embodiment, by setting the drug delivery tube 231 as a nickel-titanium alloy tube, the diameter of the drug injection assembly 2 can be significantly reduced.

[0073] Based on the above embodiments, the force-sensing micro instrument provided by the present invention further includes a drug delivery assembly 3. As Figure 1 and Figure 5 shown, the drug delivery assembly 3 includes a joint assembly 31, a first pressure extension tube 32, and a transfer tube 33. One end of the first pressure extension tube 32 is connected to the joint assembly 31, and the other end is connected to the drug injection needle tube 23 through the transfer tube 33. The joint assembly 31 is connected to one end of the housing 1 away from the bent needle tip 230.

[0074] Among them, the joint assembly 31, the first pressure extension tube 32, the transfer tube 33, and the drug injection needle tube 23 are connected in sequence to form a drug delivery channel. The joint assembly 31 is used to connect to a dedicated device for drug injection and provide drug injection pressure. The liquid medicine flows through the first pressure extension tube 32 and the transfer tube 33 in sequence and then enters the drug injection needle tube 23.

[0075] Specifically, as Figure 15 shown, the joint assembly 31 includes a first Luer connector 311, a blade ring 312, and a split joint 313. The blade ring 312 is arranged inside the first Luer connector 311. One end of the split joint 313 is connected to the first pressure extension tube 32, and the other end is connected and fixed to the first Luer connector 311 through the blade ring 312. Optionally, the first Luer connector 311 is a female Luer connector.

[0076] In the embodiment of the present invention, both ends of the housing 1 are respectively connected to the joint assembly 31 and the tube seat 41, so that the part between the joint assembly 31 and the tube seat 41 is encapsulated inside the housing 1, which is convenient for hand-held operation.

[0077] Further, the drug delivery assembly 3 further includes a second pressure extension tube 34 and a three-way valve 35. One end of the second pressure extension tube 34 is connected to the three-way valve 35, and the other end is detachably connected to the joint assembly 31. Among them, the three-way valve 35, the second pressure extension tube 34, the joint assembly 31, the first pressure extension tube 32, the transfer tube 33, and the drug injection needle tube 23 are connected in sequence to form a drug delivery channel.

[0078] Specifically, refer to Figure 15, the medicine delivery assembly 3 further includes a second luer connector 36 and a third luer connector 37. Both ends of the second pressure extension tube 34 are respectively connected to the second luer connector 36 and the third luer connector 37, and are connected to the first luer connector 311 through the second luer connector 36, and are connected to the three-way valve 35 through the third luer connector 37. Optionally, the second luer connector 36 is a male luer connector, and the third luer connector 37 is a female luer connector.

[0079] When manual injection through a syringe is required, connect the second luer connector 36 to the first luer connector 311, then sequentially connect the second pressure extension tube 34, the third luer connector 37, and one interface of the three-way valve 35, and connect the syringe to the other interface of the three-way valve 35. When injection through a dedicated device is required, remove the second luer connector 36 from the first luer connector 311 and connect the first luer connector 311 to the dedicated device.

[0080] Among them, the three-way valve 35 has a first interface, a second interface, and a third interface. The first interface is connected to the second pressure extension tube 34 through the third luer connector 37. The second interface is used to connect a thin syringe, and the third interface is used to connect a thick syringe.

[0081] Before puncture injection, connect the thin syringe to the first interface, adjust the three-way valve 35 to connect the first interface and the second interface. Inject the liquid medicine into the medicine delivery channel through the thin syringe to fill the medicine delivery channel with the liquid medicine to expel the air in the medicine delivery channel. During this process, when all the liquid medicine in the thin syringe is injected and additional liquid medicine is needed, adjust the three-way valve 35 to switch the second interface to be connected to the third interface, and supplement the liquid medicine in the thin syringe through the thick syringe. After supplementation, adjust the three-way valve again to switch the second interface to be connected to the first interface and continue to inject the liquid medicine into the medicine delivery channel. Repeat this cycle until the medicine delivery channel is filled with the liquid medicine.

[0082] As Figure 10 、 Figure 11 and Figure 12 shown, the adapter tube 33 includes a first tube body 331 and a second tube body 332. The first pressure extension tube 32 is sleeved on one end of the first tube body 331, and the other end of the first tube body 331 is sleeved on one end of the second tube body 332. The end of the injection needle tube 23 away from the bent needle tip 230 is inserted into the other end of the second tube body 332.

[0083] Specifically, the drug delivery tube 231 of the drug injection syringe 23 is inserted into the other end of the second tube body 332. After the second tube body 332 is inserted into the first tube body 331, a stepped channel is formed in the adapter tube 33, which can reduce the local pressure loss caused by the decrease in pipe diameter when the liquid medicine flows from the adapter tube 33 to the drug injection syringe 23, thereby reducing the energy loss and flow resistance, and enabling the liquid medicine to smoothly flow into the drug injection syringe 23 through the stepped channel. The insertion depth of the second tube body 332 into the first tube body 331 can be adjusted, so that the length of the drug delivery assembly 3 has a certain adjustment margin.

[0084] Optionally, referring to Figure 12 , a tapered connection portion is provided at one end of the first tube body 331, so that the first tube body 331 is tightly connected to the first pressure extension tube 32 through the tapered connection portion.

[0085] Furthermore, referring to Figure 12 , the second tube body 332 is provided with a connected first channel 3321 and a second channel 3322. The diameter of the second channel 3322 is larger than that of the first channel 3321, and the drug injection syringe 23 is inserted into the first channel 3321. That is to say, a stepped channel is provided in the second tube body 332. When the second tube body 332 is inserted into the middle area of the first tube body 331, a stepped channel with two steps can be formed in the adapter tube 33, including three channels with gradually decreasing diameters. In this way, the pressure loss caused by the decrease in pipe diameter when the liquid medicine flows from the adapter tube 33 to the drug injection syringe 23 can be further reduced.

[0086] When assembling the adapter tube 33 and the drug injection syringe 23, a cylindrical plug is pre-inserted into the second channel 3322 of the second tube body 332, and then the drug injection syringe 23 is inserted into the first channel 3321. The drug injection syringe 23 is positioned by the plug, so that the end of the drug injection syringe 23 is flush with the end of the first channel 3321. The drug injection syringe 23 is adhesively fixed and sealed to the second tube body 332 by a biocompatible glue. Then the plug is removed, and the end of the second tube body 332 away from the drug injection syringe 23 is inserted into the first tube body 331, and the second tube body 332 is adhesively fixed and sealed to the first tube body 331 by a biocompatible glue.

[0087] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions described in the foregoing embodiments, or perform equivalent replacements on some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A force-sensing micromanipulation instrument, characterized in that, Comprising: Outer shell; Drug injection assembly, including a drug injection syringe, a first optical fiber and a second optical fiber; a bent needle head is provided at the distal end of the drug injection syringe; the first optical fiber and the second optical fiber are distributed along the length direction of the drug injection syringe on the outer periphery of the drug injection syringe and encapsulated in the outer shell; the first optical fiber and the second optical fiber are Bragg optical fibers, and both the first optical fiber and the second optical fiber are provided with two mutually spaced grating regions, and the grating regions are used to sense the radial force received by the drug injection syringe; The force-sensing micro instrument can obtain the radial force received by the drug injection syringe according to the mapping relationship between the radial force and the reflection wavelength change rate sensed by the grating region, so as to obtain the puncture force F of the tip of the bent needle; the puncture force F is decomposed into a radial force along the radial direction of the drug injection syringe , the radial force is decomposed into a radial force along the X direction and a radial force along the Y direction and a radial force ; The mapping relationship is: ； wherein, are the wavelength change rates corresponding to the four grating regions respectively, r is the distance between the central axis of the optical fiber and the central axis of the drug injection syringe, E is the elastic modulus of the optical fiber, is the moment of inertia of the cross section of the optical fiber in the X direction, is the moment of inertia of the cross section of the optical fiber in the Y direction, is the included angle between the second optical fiber and the radial force ; is the included angle between the first optical fiber and the radial force ; , , , ; the distances between the tip of the bent needle and the centers of the two grating regions of the second optical fiber are respectively , and the distances between the tip of the bent needle and the centers of the two grating regions of the first optical fiber are respectively are the strain constants corresponding to the four grating regions respectively.

2. The force-sensing micromanipulation instrument according to claim 1, wherein The first optical fiber and the second optical fiber have the same structure.

3. The force-sensing microinstrument according to claim 1, wherein The drug injection assembly further includes: a potting part, the potting part is provided with a first potting channel, a second potting channel and a third potting channel, the first optical fiber is disposed through the first potting channel, the second optical fiber is disposed through the second potting channel, and the drug injection syringe is disposed through the third potting channel.

4. The force-sensing micromanipulation instrument according to claim 3, wherein, Further comprising: A sleeve, including a tube seat and a straight tube, the tube seat is connected to one end of the outer shell close to the bent needle head, one end of the straight tube is disposed through the tube seat, the potting part is disposed through the straight tube, and the grating region is located outside the straight tube.

5. The force-sensing micromanipulation instrument according to any one of claims 1 to 4, characterized in that, The drug injection syringe includes: a drug delivery tube and a drug injection needle; one end of the drug injection needle is inserted into the drug delivery tube and is hermetically connected to the drug delivery tube, and the bent needle head is formed at the end of the drug injection needle away from the drug delivery tube.

6. The force-sensing micromanipulation instrument according to claim 5, wherein The drug delivery tube is a nitinol tube.

7. The force-sensing micromanipulation instrument according to any one of claims 1 to 4, characterized in that, Further comprising: A drug delivery assembly, including a connector assembly, a first pressure extension tube and an adapter tube, one end of the first pressure extension tube is connected to the connector assembly, and the other end is connected to the drug injection syringe through the adapter tube, and the connector assembly is connected to one end of the outer shell away from the bent needle head.

8. The force-sensing micromanipulation instrument according to claim 7, wherein, The drug delivery assembly further includes: a second pressure extension tube and a three-way valve, one end of the second pressure extension tube is connected to the three-way valve, and the other end is detachably connected to the connector assembly.

9. The force-sensing microinstrument according to claim 7, wherein The adapter tube includes: a first tube body and a second tube body, one end of the first pressure extension tube is sleeved on one end of the first tube body, the other end of the first tube body is sleeved on one end of the second tube body, and the end of the drug injection syringe away from the bent needle head is inserted into the other end of the second tube body.

10. The force-sensing micromanipulation instrument according to claim 9, wherein The second tube body is provided with a connected first channel and a second channel, the diameter of the second channel is larger than the diameter of the first channel, and the drug injection syringe is inserted into the first channel.

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