A hysteroscopic-adaptive ultrasound imaging intrauterine injection device and its length control structure

Abstract

This invention relates to the field of medical devices, disclosing a hysteroscopy-adapted ultrasound-guided intrauterine injection device and its length control structure. The device includes a needle assembly, an injection assembly, and a length control assembly. The needle tip presents a clear, strong echogenic spot under ultrasound guidance, and an imaging ring is provided at the needle tip, achieving precise positioning under both direct hysteroscopic visualization and ultrasound guidance. This invention utilizes a piezoelectric thin-film sensor and a fiber optic pressure sensor to monitor resistance changes during needle tip puncture, identifies the binding zone using pressure mutations, and incorporates a vibration alert structure and physical methods to assist doctors in determining the puncture depth. Furthermore, the inner wall of the needle tip is coated with a diamond-like carbon (DLC) or perfluoropolyether (PFPE) lubricating layer to reduce wall friction and address the problem of adhesion and residue of highly viscous drugs. This invention significantly improves the accuracy and safety of intrauterine drug delivery through multimodal sensing and functional coating.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a hysteroscopy-compatible ultrasound imaging intrauterine injection device and its length control structure. Background Technology

[0002] Intrauterine injection devices are medical tools used to directly inject drugs or liquids into the uterine cavity. They typically consist of a syringe, catheter, and connecting components. Under the guidance of a doctor, they can precisely deliver medications into the uterine cavity. By injecting substances such as granulocyte colony-stimulating factor and human chorionic gonadotropin, they can promote the growth and repair of the endometrium and improve its receptivity to embryos. They are often used in assisted reproductive treatments for patients with recurrent implantation failure or thin endometrium.

[0003] A hysteroscopic endometrial injection needle is disclosed in publication number CN106075666B, comprising a needle tip, a curved section, a needle body, and a pull cord. The needle tip has graduations. The curved section is located between the needle tip and the needle body. A fixing hole is provided at the connection between the needle tip and the curved section, and a guide hole is provided at the connection between the needle body and the curved section. One end of the pull cord is fixed in the fixing hole, and the free end of the pull cord extends through the guide hole along the needle body to the end of the needle body. A drug delivery port is provided at the end of the needle body. This injection needle can inject into different locations within the uterus, and the injection depth is visible. By pulling and releasing the pull cord, the curvature of the curved section can be controlled, thereby adjusting the direction of the needle tip and achieving omnidirectional injection. Observing the graduations on the needle tip through a hysteroscope allows for more accurate control of the injection depth.

[0004] The inventors of this application discovered in their research that the core defect of the aforementioned prior art is that, in order to ensure the softness of the needle, the materials commonly used in the injection device cannot be clearly visualized under ultrasound. Consequently, the injection device appears blurry under ultrasound imaging during the injection process, making it inconvenient for medical staff to observe. Furthermore, due to individual differences among patients, even if the thickness of the junctional fold is measured before the procedure, medical staff can only rely on experience to judge the puncture depth, which can easily cause the needle tip to pass through the junctional fold, affecting subsequent drug administration. Summary of the Invention

[0005] This invention provides a hysteroscopic-compatible ultrasound-guided intrauterine injection device and its length control structure, which solves the problem of unclear needle tip under ultrasound imaging and enables medical staff to easily observe the device using clear ultrasound imaging.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a hysteroscopic-adaptive ultrasound imaging intrauterine injection device, comprising a needle assembly, an injection assembly, and a length control assembly, wherein one end of the needle assembly is inserted into one end of the injection assembly, and the interior of the length control assembly is disposed outside the needle assembly;

[0007] The needle assembly includes a mounting head, one end of which is connected to an adjustment tube. Adjustment grooves are formed on both sides of the adjustment tube. One end of the adjustment tube is connected to a needle tip. The needle tip is made of nickel-titanium alloy. A display ring is fixedly connected to the outside of the needle tip. A fiber optic pressure sensor is installed at one end of the needle tip. A needle hole is formed at one end of the needle tip. A laser etching groove is formed on the outside of the needle tip. A biomimetic hydrophobic coating is sprayed inside the needle hole.

[0008] By adopting the above technical solution, a nickel-titanium alloy needle with shape memory function is used to ensure that it can pass smoothly without breaking when the hysteroscopic operating channel is curved. In addition, the inner wall of the needle is sprayed with a biomimetic hydrophobic coating, which greatly reduces the friction of the wall surface of highly viscous drugs such as gels, reduces drug residue, and ensures the accuracy of micro-drug administration. The distal end of the needle tip adopts laser micro-etching technology, which utilizes the coherent scattering principle of ultrasound to make the needle tip present a clear strong echo light spot under the guidance of ultrasound.

[0009] Preferably, the injection assembly includes an injection tube, a piston is slidably connected inside the injection tube, a piezoelectric thin film sensor is installed on one side of the piston, a push rod is fixedly connected to the other side of the piston, a push plate is fixedly connected to one end of the push rod, a metal impact plate is fixedly connected inside the push plate, and a servo motor is installed inside the push rod.

[0010] Preferably, the output end of the servo motor is fixedly connected to a motor ratchet, the motor ratchet is rotatably connected inside the push rod, and a firing pin ratchet is slidably connected inside the push rod.

[0011] Preferably, a metal striking pin is fixedly connected to the bottom of the striking pin ratchet, and a rotating plate is rotatably connected to the bottom of the motor ratchet.

[0012] Preferably, a first telescopic rod is fixedly connected to the bottom of the rotating plate, the bottom of the first telescopic rod is fixedly connected to the top of the firing pin ratchet, and a tension spring is fixedly connected to the bottom of the rotating plate through the top of the firing pin ratchet.

[0013] By adopting the above technical solution, integrating fiber optic pressure sensors and piezoelectric thin film sensors, for high-viscosity substances such as gels, the pressure change during injection can reflect the diffusion of drugs in tissues. If the pressure is too high and does not decrease, it indicates that the needle tip may be tightly attached to the muscle layer or in an extremely narrow gap, and the drug cannot disperse. If the pressure is in a stable range, it confirms that the drug is uniformly diffused in the gap of the intima-binding zone, ensuring the quality of drug administration.

[0014] Preferably, in a length control structure, the length control component includes a length control tube, one end of which is fixedly connected to a pull wire, one end of which is slidably connected inside the length control tube, one end of which is fixedly connected to a pull ring, and one end of the length control tube is connected to an outer sliding tube.

[0015] Preferably, one end of the outer slide tube is fixedly connected to a guide tube, the outer slide tube has a threaded groove on its exterior, and a knob is threadedly connected to the exterior of the outer slide tube.

[0016] Preferably, a rotating ring is rotatably connected to the bottom of the knob, and a plug rod is fixedly connected to the bottom of the rotating ring. The plug rod is slidably connected to the inside of the guide tube.

[0017] Preferably, one end of the guide tube is fixedly connected to a limiting body, a guide rod is fixedly connected inside the limiting body, a second telescopic rod is fixedly connected inside the limiting body, and a hollow rod is slidably connected to the outside of the guide rod.

[0018] Preferably, one end of the hollow rod is fixedly connected to a spring through the interior of the limiting body, one end of the hollow rod is fixedly connected to a slider, one side of the slider is fixedly connected to a locking block, and one side of the slider is fixedly connected to one end of the second telescopic rod.

[0019] By adopting the above technical solution, the drug delivery layer is forcibly limited by the locking structure, the needle tip is adjustable by the limiting structure, and the intima thickness is measured by ultrasound before the operation. The exposed length of the needle tip is locked at a value slightly deeper than this, ensuring that the needle tip just touches the junctional zone.

[0020] This invention provides a hysteroscopic-adaptive ultrasound-guided intrauterine injection device and its length control structure. It offers the following advantages:

[0021] 1. This invention features a nickel-titanium alloy needle tip with shape memory function, ensuring smooth passage without breakage even when the hysteroscopic operating channel is curved. The inner wall of the needle tip is coated with a biomimetic hydrophobic coating to reduce wall friction and minimize drug residue. Furthermore, the distal end of the needle tip is laser-micro-etched with tiny pits, utilizing the coherent scattering principle of ultrasound to create a clear, strong echo point under ultrasound guidance. An imaging ring is incorporated at the needle tip, which not only indicates depth under direct hysteroscopic visualization but also clearly identifies the specific layer of the injection needle entering the endometrium under ultrasound. This assists in achieving clear imaging of the injection device under ultrasound, solving the problem of unclear imaging in traditional hysteroscopic injection devices under ultrasound.

[0022] 2. This invention utilizes a piezoelectric thin film sensor and an optical fiber pressure sensor to monitor changes in resistance during needle puncture. By detecting abrupt changes in pressure feedback, it determines whether the junctional zone has been reached. Furthermore, a vibration alert structure is incorporated to ensure that the injection process is not affected while simultaneously alerting medical personnel. Compared to relying solely on sensors to observe injection pressure data, vibration provides a more effective alert, thus resolving the issue that injection devices cannot assist medical personnel in determining puncture depth.

[0023] 3. This invention sets a length control tube that slides outside the needle tip, uses a snap-fit ​​structure for adjustment, and sets a locking structure to fix the movement of the length control tube. This allows the device to change the exposed length of the needle tip according to the injection requirements, locking the exposed length of the needle tip to a length slightly longer than the thickness of the inner membrane. This ensures that the needle tip just touches the junction zone, solving the problem that traditional injection devices are not easy to control the depth of the needle tip. Attached Figure Description

[0024] Figure 1 This is a perspective view of the entire invention;

[0025] Figure 2 This is a side view of the present invention;

[0026] Figure 3 This is a cross-sectional view of the injection component of the present invention;

[0027] Figure 4 This is a cross-sectional view of the push rod of the present invention;

[0028] Figure 5 This is a schematic diagram of the firing pin ratchet of the present invention;

[0029] Figure 6 This is a schematic diagram of the length control component of the present invention;

[0030] Figure 7 This is a schematic diagram of the outer sliding tube of the present invention;

[0031] Figure 8 This is an enlarged view of point A in the present invention;

[0032] Figure 9 This is an enlarged view of section B of the present invention;

[0033] Figure 10 This is an enlarged view of point C in the present invention;

[0034] Figure 11 This is an enlarged view of point D in the present invention.

[0035] Among them, 1. needle assembly; 2. injection assembly; 3. length control assembly;

[0036] 101. Mounting head; 102. Adjustment tube; 103. Adjustment groove; 104. Needle tip; 105. Imaging ring; 106. Pinhole; 107. Fiber optic pressure sensor; 108. Laser etching groove;

[0037] 201. Injection tube; 202. Push rod; 203. Push plate; 204. Metal impact plate; 205. Piston; 206. Piezoelectric film sensor; 207. Servo motor; 208. Motor ratchet; 209. Target ratchet; 210. Metal target; 211. Rotating plate; 212. First telescopic rod; 213. Tension spring;

[0038] 301. Length control tube; 302. Pull wire; 303. Pull ring; 304. Outer sliding tube; 305. Threaded groove; 306. Knob; 307. Rotating ring; 308. Connecting rod; 309. Guide tube; 310. Limiting body; 311. Second telescopic rod; 312. Slider; 313. Locking block; 314. Hollow rod; 315. Guide rod; 316. Spring. Detailed Implementation

[0039] 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 a part of the embodiments of the present invention, and not all of them. 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.

[0040] Example 1:

[0041] Please see the appendix Figure 1 - Appendix Figure 11 This invention provides a hysteroscopy-adapted ultrasound imaging intrauterine injection device, including a needle assembly 1, an injection assembly 2, and a length control assembly 3. One end of the needle assembly 1 is inserted into one end of the injection assembly 2, and the interior of the length control assembly 3 is disposed outside the needle assembly 1.

[0042] The needle assembly 1 includes a mounting head 101, one end of which is connected to an adjustment tube 102. Adjustment grooves 103 are provided on both sides of the adjustment tube 102. One end of the adjustment tube 102 is connected to a needle tip 104. The needle tip 104 is made of nickel-titanium alloy. A display ring 105 is fixedly connected to the outside of the needle tip 104. A fiber optic pressure sensor 107 is installed at one end of the needle tip 104. A pinhole 106 is provided at one end of the needle tip 104. A laser etching groove 108 is provided on the outside of the needle tip 104. A biomimetic hydrophobic coating is sprayed inside the pinhole 106.

[0043] Specifically, the installation head 101 can assist the needle assembly 1 in being inserted into one end of the adjustment tube 102. The needle tip 104 can guide the needle tip 104 under ultrasound guidance during puncture. The needle tip 104 adopts a closed conical head and has micro-needle holes 106 on its side wall to prevent the needle tip 104 from directly pressing against the tissue and causing gel blockage. At the same time, it allows the drug to diffuse evenly in an umbrella shape under the endometrium, expanding the coverage of the drug effect. The tube part of the needle tip 104 is made of nickel-titanium alloy with shape memory function to ensure that it can still pass smoothly without breaking when the hysteroscopic operation channel is curved. The distal end of the needle tip 104 uses laser micro-etching technology to create micro-pits or prism structures with specific arrangements. Utilizing the coherent scattering principle of ultrasound, the needle tip 104 presents a clear strong echo light spot under ultrasound guidance.

[0044] Please see the appendix Figure 3 , Figure 4 , Figure 5 and attached Figure 10 The injection assembly 2 includes an injection tube 201, with a piston 205 slidably connected inside the injection tube 201. A piezoelectric thin film sensor 206 is mounted on one side of the piston 205, and a push rod 202 is fixedly connected to the other side of the piston 205. A push plate 203 is fixedly connected to one end of the push rod 202, and a metal impact plate 204 is fixedly connected inside the push plate 203. A servo motor 207 is installed inside the push rod 202, and a motor ratchet 208 is fixedly connected to the output end of the servo motor 207. 208 is rotatably connected inside the push rod 202. Inside the push rod 202, a firing pin ratchet 209 is slidably connected. A metal firing pin 210 is fixedly connected to the bottom of the firing pin ratchet 209. A rotating plate 211 is rotatably connected to the bottom of the motor ratchet 208. A first telescopic rod 212 is fixedly connected to the bottom of the rotating plate 211. The bottom of the first telescopic rod 212 is fixedly connected to the top of the firing pin ratchet 209. A tension spring 213 is fixedly connected to the bottom of the rotating plate 211 through the top of the firing pin ratchet 209.

[0045] Specifically, medical staff can use the push rod 202 and push plate 203 to push the piston 205, using positive and negative pressure to control the ejection and aspiration of the drug inside the injection tube 201. During the pushing process, the medical staff's thumb contacts the metal impact plate 204. The piezoelectric film sensor 206 and fiber optic pressure sensor 107 can detect the effects of tissue density and drug injection pressure, respectively. When the pressure detected by the piezoelectric film sensor 206 and fiber optic pressure sensor 107 exceeds the preset value, the servo motor 207 drives the motor ratchet 208 to rotate, and the impact pin ratchet 209 and metal impact pin 210 strike the metal impact plate 204. The first telescopic rod 212 and tension spring 213 are used for reset, thereby alerting the medical staff through vibration and preventing over-puncture. Compared with traditional injection devices that rely on medical staff to observe pressure data to judge the puncture depth, this embodiment uses pressure sensing for feedback and uses sensors to monitor the resistance changes during needle tip puncture (the endometrial tissue is relatively loose, while the junctional and muscle layer tissues are relatively dense). The pressure feedback abrupt change point determines whether the junctional zone has been reached, and a vibration reminder structure is set up to ensure that the device injection is not affected, while tactile reminders are used to assist medical staff in judging the puncture depth.

[0046] Please see the appendix Figure 1 - Appendix Figure 11This invention provides a length control structure. The length control component 3 includes a length control tube 301. One end of the length control tube 301 is fixedly connected to a pull wire 302, and one end of the pull wire 302 is slidably connected inside the length control tube 301. One end of the pull wire 302 is fixedly connected to a pull ring 303. One end of the length control tube 301 is connected to an outer sliding tube 304. One end of the outer sliding tube 304 is fixedly connected to a guide tube 309. A threaded groove 305 is formed on the outside of the outer sliding tube 304. A knob 306 is threadedly connected to the outside of the outer sliding tube 304. A rotating ring 307 is rotatably connected to the bottom of the knob 306. A plug rod 3 is fixedly connected to the bottom of the rotating ring 307. 08. The external sliding connection of the plug rod 308 is connected to the inside of the guide tube 309. One end of the guide tube 309 is fixedly connected to the limiting body 310. The inside of the limiting body 310 is fixedly connected to the guide rod 315. The inside of the limiting body 310 is fixedly connected to the second telescopic rod 311. The external sliding connection of the guide rod 315 is a hollow rod 314. One end of the hollow rod 314 is fixedly connected to the inside of the limiting body 310 via a spring 316. One end of the hollow rod 314 is fixedly connected to a slider 312. One side of the slider 312 is fixedly connected to a locking block 313. One side of the slider 312 is fixedly connected to one end of the second telescopic rod 311.

[0047] Specifically, the length control component 3 can be inserted into the needle assembly 1, and the outer sliding tube 304 and guide tube 309 can slide outside the adjusting tube 102 until the needle tip 104 protrudes slightly longer than the endometrial thickness. During this process, the locking block 313 moves outside the adjusting groove 103 using the spring 316 and the second telescopic rod 311 until the knob 306 is rotated, causing the insertion rod 308 to move inside the guide tube 309. The insertion rod 308 then engages with one side of the slider 312 for fixation, thereby preventing the length control tube 301 from moving. Compared with traditional injection devices, this application uses mechanical and physical depth control, through the hardware design of the length control structure, to forcibly limit the drug delivery layer and adaptively limit the depth. In use, a segmentable locking structure is designed at the distal end of the length control tube 301. Based on the endometrial thickness measured by preoperative ultrasound (e.g., the endometrial single-layer thickness is 3mm), the exposed length of the needle tip is locked at a value slightly deeper than this, ensuring that the needle tip just touches the junction. The specific principle is as follows:

[0048] The length control tube 301 is set to slide outside the needle tip 104, and is adjusted by a snap-fit ​​structure. A locking structure is also set to fix the movement of the length control tube 301. This allows the device to change the exposed length of the needle tip 104 according to the injection requirements, locking the exposed length of the needle tip to a length slightly longer than the thickness of the inner membrane. This ensures that the needle tip 104 just touches the junction zone, solving the problem that traditional injection devices are not easy to control the needle tip depth.

[0049] Example 2: As a supplement to Example 1, the piezoelectric film sensor 206 and the fiber optic pressure sensor 107 can be integrated micro pressure sensors. When the needle tip touches and punctures into the junctional zone, the tissue density increases, and the resistance curve will show a significant abrupt change in slope. After the system detects this pressure characteristic, it can also remind the doctor that the precise drug delivery level has been reached through audible and visual alarms or mechanical self-locking, effectively preventing penetration of the muscle layer. Compared with traditional injection devices that only use pressure sensors to display data, this example can better remind the doctor to judge the puncture depth through physical means. The inner wall of the needle tip 104 is prepared with a diamond-like carbon (DLC) coating or a perfluoropolyether (PFPE) lubricating layer, which greatly reduces the wall friction for highly viscous drugs such as gels, reduces drug residue (non-adhesion), and ensures the accuracy of drug delivery (such as growth factors and stem cell gels).

[0050] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A hysteroscopic-adaptive ultrasound-guided intrauterine injection device, comprising a needle assembly (1), an injection assembly (2), and a length control assembly (3), characterized in that, One end of the needle assembly (1) is inserted into one end of the injection assembly (2), and the interior of the length control assembly (3) is disposed outside the needle assembly (1); The needle assembly (1) includes a mounting head (101), one end of which is connected to an adjustment tube (102). Adjustment grooves (103) are provided on both sides of the adjustment tube (102). One end of the adjustment tube (102) is connected to a needle tip (104). The needle tip (104) is made of nickel-titanium alloy. A display ring (105) is fixedly connected to the outside of the needle tip (104). A fiber optic pressure sensor (107) is installed at one end of the needle tip (104). A pinhole (106) is provided at one end of the needle tip (104). A laser etching groove (108) is provided on the outside of the needle tip (104). A biomimetic hydrophobic coating is sprayed inside the pinhole (106).

2. The hysteroscopic-adapted ultrasound imaging intrauterine injection device according to claim 1, characterized in that, The injection assembly (2) includes an injection tube (201), a piston (205) is slidably connected inside the injection tube (201), a piezoelectric thin film sensor (206) is installed on one side of the piston (205), a push rod (202) is fixedly connected to the other side of the piston (205), a push plate (203) is fixedly connected to one end of the push rod (202), a metal impact plate (204) is fixedly connected inside the push plate (203), and a servo motor (207) is installed inside the push rod (202).

3. The hysteroscopic-adapted ultrasound imaging intrauterine injection device according to claim 2, characterized in that, The output end of the servo motor (207) is fixedly connected to a motor ratchet (208), which is rotatably connected inside the push rod (202). The push rod (202) is slidably connected to a firing pin ratchet (209).

4. The hysteroscopic-adapted ultrasound imaging intrauterine injection device according to claim 3, characterized in that, The bottom of the firing pin ratchet (209) is fixedly connected to a metal firing pin (210), and the bottom of the motor ratchet (208) is rotatably connected to a rotating plate (211).

5. The hysteroscopic-adapted ultrasound imaging intrauterine injection device according to claim 4, characterized in that, The bottom of the rotating plate (211) is fixedly connected to a first telescopic rod (212), the bottom of the first telescopic rod (212) is fixedly connected to the top of the firing pin ratchet (209), and the bottom of the rotating plate (211) is fixedly connected to a tension spring (213) through the top of the firing pin ratchet (209).

6. A length-controlling structure, characterized in that, For a hysteroscopy-adapted ultrasound imaging intrauterine injection device according to any one of claims 1-5, the length control component (3) includes a length control tube (301), one end of the length control tube (301) is fixedly connected to a pull wire (302), one end of the pull wire (302) is slidably connected inside the length control tube (301), one end of the pull wire (302) is fixedly connected to a pull ring (303), and one end of the length control tube (301) is connected to an external sliding tube (304).

7. The length control structure according to claim 6, characterized in that, One end of the outer slide tube (304) is fixedly connected to a guide tube (309), the outer slide tube (304) has a threaded groove (305) on its outside, and a knob (306) is threadedly connected to the outside of the outer slide tube (304).

8. The length control structure according to claim 7, characterized in that, The bottom of the knob (306) is rotatably connected to a rotating ring (307), and the bottom of the rotating ring (307) is fixedly connected to a plug rod (308). The outside of the plug rod (308) is slidably connected to the inside of the guide tube (309).

9. The length control structure according to claim 8, characterized in that, One end of the guide tube (309) is fixedly connected to a limiting body (310), a guide rod (315) is fixedly connected inside the limiting body (310), a second telescopic rod (311) is fixedly connected inside the limiting body (310), and a hollow rod (314) is slidably connected to the outside of the guide rod (315).

10. The length control structure according to claim 9, characterized in that, One end of the hollow rod (314) is fixedly connected to a spring (316) through the inside of the limiting body (310). One end of the hollow rod (314) is fixedly connected to a slider (312). One side of the slider (312) is fixedly connected to a locking block (313). One side of the slider (312) is fixedly connected to one end of the second telescopic rod (311).

Images