Automatically adjustable anal fistula probe positioning device

Abstract

The invention discloses an anal fistula probe positioning device capable of being automatically adjusted, and belongs to the technical field of medical equipment. The device comprises a needle seat, a nickel-titanium memory alloy probe with the phase change temperature consistent with the human body temperature is installed at the front end of the needle seat, the end of the probe is connected with a miniature ultrasonic probe with a guide seat, the direction of the guide seat is controlled through a first traction line, a second traction line, a corresponding first motor and a corresponding second motor, and automatic adjustment of the direction of the probe is achieved through a miniature pressure sensor and a control module. The surface of the probe is provided with a groove and sleeved with a film pipe sleeve, an electric heating wire is embedded in the probe, and the rear end of the probe seat is connected with a silica gel ring, a corrugated sheet, a grip and a signal transmission wire. The memory alloy probe conforms to the shape of a fistula, and tissue damage is avoided; the miniature ultrasonic probe performs real-time imaging to solve the problem of blind vision; pressure sensing is linked with the motor to achieve automatic steering of the probe, positioning precision and operation safety are improved, vibration is reduced through a holding structure, and operation stability is guaranteed.

Description

Technical Field

[0001] The invention belongs to the technical field of medical equipment, and in particular relates to an automatically adjustable anal fistula probe positioning device. Background Art

[0002] Anal fistulas are a common and frequently occurring condition in anorectal surgery. They primarily refer to abnormal pathological tracts that form between the anal canal or rectum and the perianal skin. They are often caused by anal gland infection, which spreads through the intersphincteric space to the perianal area, eventually rupturing to form an external opening, creating a chronic infectious channel connecting the internal opening of the rectum with the external opening of the perianal skin. The course of fistulas is complex and varied, potentially traversing different sphincteric layers, forming complex structures that curve, bifurcate, or even horseshoe-shaped.

[0003] Anal fistula probes are key instruments used during surgery to explore the direction of fistulas and locate the internal opening. Traditional probes are usually made of metal (such as silver), have a certain hardness and toughness, and have a rounded and blunt head. When in use, the doctor tries to insert the probe from the external opening and slowly advance it along the direction of the fistula tract, hoping to eventually pass it out from the internal opening, thereby clarifying the path of the fistula. Existing probes have many shortcomings: traditional metal probes are mostly straight rods or have only limited curvature, which are difficult to adapt to the complex and curved fistula morphology. Forced exploration may lead to false channel formation, bleeding or perforation, increasing the difficulty and risk of surgery; the probe's movement in the tissue is completely "blind", and the accuracy of locating the internal and external openings depends entirely on the doctor's subjective judgment and marking after the probe passes through the internal opening. Existing devices also lack real-time guidance, which is not easy to operate when positioning the probe. Summary of the Invention

[0004] In order to solve the problems mentioned above, the present invention proposes an automatically adjustable anal fistula probe positioning device. The device uses a flexible memory metal material to make the probe body, which can adapt to complex fistulas, and integrates a miniature ultrasound probe in the probe head. The real-time signal is then transmitted to an external display through a wire to display the fistula status in real time, which is convenient for marking the positions of the internal and external openings. At the same time, the device can automatically adjust the direction of the ultrasound probe on the probe head according to the direction of the fistula, and then smoothly guide the probe body to smoothly extend into the fistula, preventing damage to the fistula and causing false passage formation, bleeding or perforation.

[0005] In order to achieve the technical objectives in the above content, the present invention is implemented through the following technical solutions:

[0006] An automatically adjustable anal fistula probe positioning device comprises a needle holder, a hole is opened at the center of the front end face of the needle holder and a probe perpendicular to the end face is fixedly installed, the probe is made of medical-grade nickel-titanium shape memory alloy, and its phase change temperature is controlled to be the same as the average body temperature of the human body, so that the human body temperature softens the probe after entering the fistula, and the probe can be naturally bent with the fistula, avoiding tissue damage caused by rigid insertion, and returning to its original shape when it is lower than the human body temperature; the front end of the probe is round-headed, an axial hole is opened at the probe end and a connecting wire is fixed in the hole, the other end of the connecting wire is fixedly connected to a miniature ultrasonic probe, the diameter of the miniature ultrasonic probe is the same as that of the probe, the contact part of the miniature ultrasonic probe and the probe is a round-headed guide seat, so that the guide seat can rotate arbitrarily with the connecting wire as the center, and the lower end of the needle holder is connected to a signal transmission wire, and the signal transmission wire The wire passes through the needle seat and is connected to the miniature ultrasound probe along the probe surface, and the other end can be connected to an external ultrasound imaging display to facilitate observation of the fistula morphology and the positioning of the internal and external openings; the left and right sides of the rear end of the guide seat are commonly connected with a first pull wire, and a fixed block is coaxially installed at the corresponding probe inside the needle seat. The tail of the fixed block is provided with a horizontal groove and the first pull wire can slide in the groove. By pulling the first pull wire left and right, the guide seat can be pulled to adjust the left and right direction of the guide seat. The upper and lower sides of the guide seat are connected in the same way with a second pull wire identical to the first pull wire. The rear end of the second pull wire passes through the fixed block and is also slidable, so that the up and down direction of the guide seat can be adjusted by pulling the second pull wire. The guide seat can be adjusted to any direction by cooperating with the two pull wires, thereby controlling the direction in which the miniature ultrasound probe guides the probe into the fistula.

[0007] The left side surface and the upper surface of the fixed block are both provided with sliding grooves in the front-to-back direction. The rear end of the first pulling wire is equipped with a first rack that can slide in the sliding groove. A first motor is installed in the needle seat and the output end of the first motor is connected to a gear that drives the first rack. The rear end of the second pulling wire is equipped with a corresponding second rack, and a second motor is installed in the same manner. The two motors are used to control the pulling of the two pulling wires respectively, thereby controlling the adjustment of the miniature ultrasound probe to different directions.

[0008] The front end of the micro-ultrasound probe is round-headed and has several evenly distributed micro-pressure sensors embedded on its surface. A control module is installed in the needle seat. The control module can receive pressure signals and control the first motor and the second motor according to the signals. The maximum pressure threshold of the control module is set in advance. When the direction of the fistula changes, the front end of the micro-ultrasound probe contacts the fistula wall and generates pressure. At this time, the micro-pressure sensor on the contact surface transmits the signal to the control module. When the pressure value of the contact surface reaches the preset value, the control module starts the rotation of the motor corresponding to the contact surface, and uses the forward or reverse rotation of the motor to control the rack to pull the pull wire forward or backward, pulling the micro-ultrasound probe toward the opposite side of the fistula contact surface, so that the contact pressure is reduced. This cycle is repeated to achieve automatic adjustment of the direction of the micro-ultrasound probe along the direction of the fistula.

[0009] The probe surface is provided with grooves with a semicircular cross-section corresponding to the first and second pull wires, so that the pull wires can be attached to the probe surface; the probe and the outer surface of the micro-ultrasound probe are sleeved with a thin film tube sleeve, and the pull wires are wrapped in the grooves on the probe surface by the thin film tube sleeve to prevent the pull wires from slipping when the probe is bent; the front end of the thin film tube sleeve corresponding to the guide seat and the connecting wire is in the shape of a corrugated tube, which facilitates the guide seat to drive the direction adjustment of the micro-ultrasound probe; the tail end of the thin film tube sleeve is connected with a fixing tape, which can fix the thin film tube sleeve on the needle seat to prevent it from slipping.

[0010] A heating wire is embedded in the inner axis of the probe, and the heating wire can heat the probe body to a temperature exceeding its own phase change temperature, making the probe soft. Heating the probe in advance by the heating wire can avoid the influence of body temperature difference on the probe, which is conducive to the probe quickly adapting to the direction of the fistula after entering the fistula.

[0011] The rear end of the needle seat is connected to a silicone ring, several corrugated sheets and a handle in sequence. The corrugated sheets are equidistantly distributed around the center of the silicone ring, and the outside of the corrugated sheet is connected by a silicone tube. The corrugated sheet and the silicone tube reduce the vibration of the needle seat when the handle is held, thereby improving the stability of the probe and thus improving the accuracy of the positioning of the miniature ultrasound probe.

[0012] Compared with the prior art, the present invention has the following beneficial effects:

[0013] 1. The probe is made of nickel-titanium shape memory alloy with a phase change temperature that matches human body temperature. Once the probe enters the fistula, it softens under the influence of body temperature and can naturally bend to conform to the complex and curved shape of the fistula, avoiding the formation of false tracts or tissue damage caused by rigid insertion. At the same time, it returns to its original shape when the temperature is below body temperature, ensuring the structural stability of the device for repeated use, thereby reducing the risk of surgical perforation and improving exploration safety.

[0014] 2. A miniature ultrasound probe is used to collect internal signals of the fistula in real time, and the image is transmitted to an external display via a signal transmission wire, allowing the doctor to intuitively observe the three-dimensional direction of the fistula and the position of the internal opening. At the same time, the guide seat and the connecting wire form a rotating pair, which cooperates with the first and second pull wires to control the deflection in the left and right and up and down directions respectively, realizing multi-degree-of-freedom directional adjustment of the probe, thereby improving the positioning accuracy of the internal and external openings and solving the blind operation problem of traditional probes.

[0015] 3. A micro pressure sensor detects the contact pressure between the probe and the fistula wall and transmits it to the control module. When the pressure exceeds the threshold, the first motor or the second motor in the corresponding direction is automatically triggered, and the first rack or the second rack is driven by the gear to move the pull wire, forming a closed-loop adjustment of "pressure signal → motor response → pull wire displacement → probe steering"; this linkage enables the probe to continuously and adaptively adjust its forward direction, guiding the probe along the natural fistula path to avoid damage to the tube wall caused by forced advancement. At the same time, the groove design wrapped in the thin film tube sleeve ensures that the pull wire does not dislocate when the probe is bent. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments.

[0017] Figure 1 This is a schematic diagram of the overall structure of Example 1 of the present invention;

[0018] Figure 2 1 is a schematic diagram of the front-end structure of embodiment 1 of the present invention;

[0019] Figure 3 is a cross-sectional view of the front end structure of Example 1 of the present invention;

[0020] Figure 4 1 is a schematic diagram of the internal structure of the needle seat according to embodiment 1 of the present invention;

[0021] Figure 5 This is a partial structural exploded diagram of Example 1 of the present invention;

[0022] Figure 6 It is a schematic diagram of the explosion of the rear section structure of Example 1 of the present invention.

[0023] The structural names represented by the numbers in the accompanying drawings are: 1-needle seat, 101-signal transmission wire, 2-probe, 201-heating wire, 3-mini ultrasonic probe, 301-guide seat, 302-connecting wire, 4-first pulling wire, 401-first rack, 5-second pulling wire, 501-second rack, 6-film tube sleeve, 601-fixing tape, 7-mini pressure sensor, 8-fixing block, 801-slide, 9-first motor, 10-second motor, 11-control module, 12-silicone ring, 13-corrugated sheet, 14-silicone tube, 15-handle. DETAILED DESCRIPTION

[0024] The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments.

[0025] Example 1

[0026] See Figures 1 to 6 As shown, and according to the contents of this specification, an automatically adjustable anal fistula probe 2 positioning device is proposed, which is mainly composed of a needle seat 1, a probe 2, a miniature ultrasonic probe 3, a pull wire control mechanism, a pressure sensor and control module 11, a film tube sleeve 6, a heating wire 201 and a gripping buffer structure, etc. Each structure works together to achieve accurate exploration and positioning of the fistula.

[0027] The needle holder 1 is made of medical-grade engineering plastics, with a hole in the center of its front end face for the fixed installation of the probe 2. The probe 2 is made of a medical-grade nickel-titanium shape memory alloy with a phase transition temperature of 36.5°C-37.5°C. This material can soften and deform at human body temperature, adapting to the curvature of the fistula and avoiding damage to the tissue due to rigid insertion. It returns to its original shape when it is below body temperature, making it easy to reuse. The front end of the probe 2 is designed to be round-headed, with an axial hole at the end. A connecting wire 302 is fixed in the hole. The other end of the connecting wire 302 is connected to a miniature ultrasonic probe 3 with the same diameter as the probe 2. The contact point between the miniature ultrasonic probe 3 and the probe 2 is a round-headed guide seat 301. The guide seat 301 can rotate freely around the connecting wire 302 to adjust the detection direction of the probe.

[0028] A fixed block 8 is coaxially mounted inside the needle holder 1, corresponding to the probe 2. A horizontal slot is formed at the rear of the fixed block 8, through which the first puller wire 4 connected to the left and right sides of the rear end of the guide seat 301 slides. A front-to-back chute 801 is formed on the left surface of the fixed block 8. A first rack 401 that can slide within the chute 801 is mounted on the rear end of the first puller wire 4. A first motor 9 is mounted inside the needle holder 1, the output end of which is connected to a gear and can drive the first rack 401, thereby pulling the first puller wire 4 left and right, and thus adjusting the left and right direction of the guide seat 301. Similarly, the second puller wire 5 is connected to the upper and lower sides of the guide seat 301. A chute 801 is formed on the upper surface of the fixed block 8. A second rack 501 is mounted on the rear end of the second puller wire 5 and driven by a second motor 10, thereby adjusting the guide seat 301 in the up and down direction.

[0029] Several evenly distributed miniature pressure sensors 7 are embedded in the rounded front end of the miniature ultrasound probe 3. A control module 11 is housed within the needle hub 1, receiving pressure signals and controlling the first and second motors 10. When the pressure of the probe against the fistula wall reaches a preset threshold, the control module 11 activates the corresponding motors, pulling the pull wires through the racks to deflect the probe toward the side opposite the pressure, achieving automatic adjustment.

[0030] A semicircular groove is cut into the surface of probe 2, corresponding to the puller wire. A thin film sleeve 6 is attached to the outer surfaces of probe 2 and micro-ultrasound probe 3. The front end of the sleeve, corresponding to the guide seat 301 and connecting wire 302, is a corrugated tube, facilitating probe orientation adjustment. The rear end is secured to the needle holder 1 with adhesive tape 601 to prevent the puller wire from slipping. A heating wire 201 is embedded in the inner axis of probe 2, heating it above its phase transition temperature to ensure it quickly softens and adapts to the fistula tract during use.

[0031] The rear end of the needle hub 1 is connected in sequence to a silicone ring 12, several corrugated sheets 13, and a handle 15. The corrugated sheets 13 are evenly spaced around the center of the silicone ring 12 and are connected by a silicone tube 14. This reduces vibration during handheld operation and improves the stability of the probe 2. The lower end of the needle hub 1 is connected to a signal transmission wire 101, which passes through the needle hub 1 and connects to a miniature ultrasound probe 3 along the surface of the probe 2. The other end can be connected to an external ultrasound imaging display to display real-time images of the fistula.

[0032] During use, the probe 2 is first heated to a temperature exceeding the phase transition temperature by the heating wire 201 to soften it. The operator holds the handle 15 and slowly inserts the front end of the probe 2 from the external opening of the anal fistula. After entering the body, the probe 2 remains softened by the body temperature and bends naturally with the fistula. The miniature ultrasound probe 3 collects internal signals of the fistula in real time and transmits them to an external display via the signal transmission wire 101, allowing the doctor to observe the direction of the fistula. When the front end of the probe contacts the fistula wall and generates pressure, the corresponding position of the micro pressure sensor 7 transmits a signal to the control module 11. If the pressure exceeds the threshold, the control module 11 starts the corresponding motor, pulls the pull wire through the gear rack mechanism, adjusts the guide seat 301 and the probe direction, and deflects it to the side opposite to the pressure, continuously adapting to the direction of the fistula. This cycle continues until the front end of the probe 2 passes through the internal opening of the anal fistula. The doctor observes and marks the position of the internal opening on the display. After completing the exploration and positioning, the probe 2 is withdrawn from the body. During the entire process, the thin film tube sleeve 6 ensures that the pull line does not slip, the silicone ring 12 and the corrugated sheet 13 structure reduce operating vibration and improve positioning accuracy, and the nickel-titanium memory alloy probe 2 avoids tissue damage, thereby achieving safe and accurate anal fistula exploration.

[0033] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit the scope of protection of the present invention. For those skilled in the art, various modifications and variations can be made to the above embodiments without departing from the principles of the present invention, and these modifications and variations should all fall within the scope of protection of the present invention.

Claims

1. An automatically adjustable anal fistula probe positioning device, characterized in that: The invention comprises a needle seat (1): a hole is opened at the center of the front end face of the needle seat (1) and a probe (2) perpendicular to the end face is fixedly installed, the probe (2) is made of medical-grade nickel-titanium shape memory alloy, and its phase change temperature is controlled to be the same as the average body temperature of the human body; the front end of the probe (2) is round-headed, an axial hole is opened at the end of the probe (2) and a connecting wire (302) is fixed in the hole, the other end of the connecting wire (302) is fixedly connected to a miniature ultrasonic probe (3), and the diameter of the miniature ultrasonic probe (3) is the same as that of the probe (2); the left and right sides of the rear end of the guide seat (301) are commonly connected to a first pulling wire (4), a fixing block (8) is coaxially installed in the needle seat (1) corresponding to the probe (2), the tail of the fixing block (8) is opened with a horizontal groove and the first pulling wire (4) can slide in the groove, and the upper and lower sides of the guide seat (301) are connected in the same way with a second pulling wire (4) identical to the first pulling wire (4). The pull line (5) and the rear end of the second pull line (5) pass through the fixed block (8) and are also slidable; the left surface and the upper surface of the fixed block (8) are both provided with a front-to-back direction slide groove (801); the rear end of the first pull line (4) is installed with a first rack (401) that can slide in the slide groove (801); the needle seat (1) is installed with a first motor (9) and the output end of the first motor (9) is connected to a gear that drives the first rack (401); the rear end of the second pull line (5) is installed with a corresponding second rack (501) and a corresponding second motor (10) is installed; the front end of the miniature ultrasonic probe (3) is round-headed and a plurality of evenly distributed miniature pressure sensors (7) are embedded and installed on the surface, and a control module (11) is installed in the needle seat (1); the control module (11) can receive pressure signals and control the first motor (9) and the second motor (10) according to the signals.

2. The automatically adjustable anal fistula probe positioning device according to claim 1, characterized in that: The probe (2) is provided with grooves with a semicircular cross-section at locations corresponding to the first and second pulling lines (5). The probe (2) and the outer surface of the micro-ultrasonic probe (3) are sleeved with a thin film tube (6). The front end of the thin film tube (6) corresponding to the guide seat (301) and the connecting line (302) is in the shape of a corrugated tube, and the tail end of the thin film tube (6) is connected with a fixing tape (601).

3. The automatically adjustable anal fistula probe positioning device according to claim 1, characterized in that: The nickel-titanium shape memory alloy used in the probe (2) has a phase transition temperature of 36.5°C-37.5°C.

4. The automatically adjustable anal fistula probe positioning device according to claim 3, characterized in that: A heating wire (201) is embedded and installed at the inner axis of the probe (2), and the heating wire (201) can heat the probe (2) body to a temperature exceeding its own phase change temperature.

5. The automatically adjustable anal fistula probe positioning device according to claim 1, characterized in that: The rear end of the needle seat (1) is sequentially connected to a silicone ring (12), a plurality of corrugated sheets (13) and a handle (15), the corrugated sheets (13) are equidistantly distributed around the center of the silicone ring (12), and the outside of the corrugated sheets (13) is sleeved by a silicone tube (14).

6. The automatically adjustable anal fistula probe positioning device according to claim 1, characterized in that: The lower end of the needle seat (1) is connected to a signal transmission wire (101), which passes through the needle seat (1) and is connected to the miniature ultrasonic probe (3) along the surface of the probe (2), and the other end of the signal transmission wire (101) can be connected to an external ultrasonic imaging display.

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