WO2023160306A1 - 一种医用导管 - Google Patents

一种医用导管 Download PDF

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Publication number
WO2023160306A1
WO2023160306A1 PCT/CN2023/072522 CN2023072522W WO2023160306A1 WO 2023160306 A1 WO2023160306 A1 WO 2023160306A1 CN 2023072522 W CN2023072522 W CN 2023072522W WO 2023160306 A1 WO2023160306 A1 WO 2023160306A1
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WIPO (PCT)
Prior art keywords
catheter
medical catheter
catheter according
distal end
lumen
Prior art date
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PCT/CN2023/072522
Other languages
English (en)
French (fr)
Inventor
王文哲
张智超
汝成韬
赵陈列
马长生
董建增
Original Assignee
上海科罡医疗技术有限公司
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Publication of WO2023160306A1 publication Critical patent/WO2023160306A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided

Definitions

  • the invention relates to the field of medical equipment, in particular to a medical catheter.
  • DSA Digital Silhouette Technology
  • Electromagnetic navigation using the frequency matching of the electromagnetic coil on the instrument and the frequency of the external electromagnetic coil to determine the position of the instrument in the body.
  • this method can only know the spatial position of the device, and cannot directly image the patient's tissue.
  • the tactile sensor at the tip of the catheter is used together with the electromagnetic coil to record the absolute position of the space while the tip of the catheter is in contact with the atrial wall. By touching more points in the atrium, the atrium outline is outlined to create a tissue image. Since the inner wall of the atrium is a convex envelope, a more accurate inner wall of the atrium can be roughly outlined by using the absolute positions of multiple points in the atrium and the approximation algorithm. However, this imaging method cannot accurately outline the rugged inner wall, especially the multi-branched human internal pipeline.
  • Intracardiac ultrasound using ultrasound to slice the heart. This method can precisely visualize the contour and location of tissues and/or instruments with different acoustic characteristics.
  • the images obtained in this way are the cross-sections of several two-dimensional images, which requires the operator to conceive the spatial state proficiently to determine the relative position of the instrument and the tissue.
  • the placement position and scanning range of the ultrasonic catheter also need to be adjusted by the operator, which is inconvenient. Due to the need for clear imaging of the entire cardiac cavity, the ultrasonic array has a large number of sensors and a large volume, which cannot be used in narrow and rugged cavity.
  • intracavity ultrasound pays more attention to the tissue structure distribution of the cavity wall, and is used to guide the surgeon to treat the cavity in the target area. This has led to its attribute of focusing on the detection of the epidermis in the cavity. At the same time, the relative relationship between it and the patient still needs image assistance such as DSA. For the detected branch cavity, the doctor still needs to use experience and operation to explore.
  • DSA can only provide projections in one direction at the same time, and cannot have a complete presentation of the structure of the spatially distributed pipelines, making it more difficult to probe into the spatially distributed branch pipelines.
  • Catheters used in the arterial system in medicine now use radiopaque materials or spray radiopaque materials in conjunction with digital silhouette technology (DSA) for catheter positioning.
  • DSA digital silhouette technology
  • the purpose of the present invention is to solve the problem that the existing medical catheter is difficult to enter the branch of the venous system, especially the fine branch, and provides a new medical catheter design, which is used to detect the structure and distribution of the human body's internal cavity, and can simultaneously It is convenient to guide the surgeon into the target bifurcation cavity to meet the needs of subsequent operations.
  • the present invention provides a medical catheter, comprising a proximal end and a distal end, the distal end comprising:
  • a sensor array to show the condition of the tube wall in the lumen
  • a coaxial rotating device which can rotate independently relative to other parts of the catheter, has a through hole connected to the outside of the catheter, and is used to establish a channel between the target branch lumen and the inside of the catheter.
  • a fixing device is used to fix the relative position of the distal end of the catheter and the inner tube wall of the lumen, so as to ensure the stability of the process of establishing a channel between the target branch lumen and the inner side of the catheter.
  • the sensor array can guide the distal hole of the rotating part with the through hole to align with the bifurcated pipeline.
  • Each individual sensor unit in the sensor array can send and receive signals independently, that is, the signal properties and emission time can be independently controlled.
  • the sensor array can guide the through holes of the coaxial rotating device with through holes to align with the bifurcated pipelines by fully displaying or partially displaying the outline of the inner wall.
  • the detection mode of the sensor array can be uniformly distributed in a ring at the distal end of the catheter, or can be distributed in any fan-shaped area of the rotating catheter.
  • the sensor array is an array of ultrasonic transducers for transmitting and receiving ultrasonic signals for detecting the inner wall contour of the cavity.
  • Ultrasonic transducer arrays Adjacent ultrasonic transducer arrays need to transmit and receive signals successively, and the arrays on both sides can simultaneously transmit and receive signals to improve imaging efficiency.
  • the sensor array can also be an electromagnetic sensor or a photoelectric sensor, which is used to directly feed back the position information of the distal end of the rotatable device relative to the main body of the catheter.
  • the sensor array can also be an optical sensor, such as optical interference imaging, a miniature wide-angle lens or a laser transceiver.
  • the fixation device can be a balloon or an elastic support.
  • the fixing device can be a nickel-titanium stent or a multi-link mechanism composed of a hard material with good biocompatibility (titanium alloy or stainless steel).
  • the fixing device has a driving end at the proximal end of the catheter, and the fixing device can be manually or automatically driven to switch states or generate deformation, so as to stabilize the relative position between the distal end of the catheter and the lumen.
  • the rotation mode of the coaxial rotating device can be manually or driven by a computer-controlled motor.
  • the coaxial rotating device can rotate independently relative to other parts of the catheter, and its rotation angle can be controlled.
  • the proximal end of the catheter and the coaxial rotating device is connected with a reliable mechanical structure.
  • the driving torque of the coaxial rotating device can be connected by the proximal end of the catheter through a flexible shaft that can transmit torque, and the distal end of the coaxial rotating device can be fed back by controlling the proximal end of the coaxial rotating device; provided by micro motors.
  • the proximal end and the distal end of the coaxial rotating device are connected with a flexible shaft that can rotate synchronously.
  • the through hole on the coaxial rotating device can be rotated so that it is angularly aligned with the target branch lumen, which helps to establish the positional relationship between the hole and the target branch lumen.
  • the relative angular relationship between the coaxial rotating device and the catheter can be provided by the structure at the proximal end and/or the set of position sensors at the distal end.
  • the relative angle relationship between the coaxial rotating device and the catheter can transmit data in real time to indicate the operator and/or the automatic control system.
  • the coaxial rotary device can guide the microcatheter or guide wire from the proximal end of the catheter, through the lumen of the catheter and out of the through hole on the coaxial rotary device at the distal end of the catheter, or the coaxial rotary device can directionally release the prefilled Substances at the distal end of the catheter, such as coils, lumen plugs, or drugs, are delivered to the distal branch lumen.
  • the distal end of the catheter may contain a distal positioning device: the distal end of the catheter may contain a radiopaque material, or the radiopaque material may be sprayed to achieve the effect of imaging under radiation; or a set of orthogonally placed A coil to achieve positioning in a magnetic field; or a series of electrodes that transmit electrical signals to achieve positioning in an electric field.
  • the aforementioned design can be realized The operator and/or the automatic control system judge the relative position of the distal end of the catheter relative to the human body and/or adjacent organs.
  • the coaxial rotatable device is coaxially rotatable with the catheter body, and its rotational position relative to the catheter body needs to be controllable, such as a reliable mechanical connection between the catheter and the proximal end of the coaxially rotatable device,
  • the proximal end and the distal end of the coaxial rotatable device are connected with a flexible shaft that can rotate synchronously, and the distal end of the rotatable device is fed back by controlling the proximal end of the coaxial rotatable device, especially the channel at the distal end to establish holes and targets The positional relationship of branch lumens.
  • Another example is using an electromagnetic sensor or a photoelectric sensor installed at the distal end of the catheter to directly feed back the position information of the distal end of the rotatable device relative to the main body of the catheter.
  • a group of ultrasonic transducer arrays or optical sensors such as near-infrared optical interference imaging (OCT), miniature wide-angle lenses or other optical interference imaging devices directly connected to the coaxial rotatable device, the sector range of the array scanning can be simultaneously Distal port of the shaft rotation device.
  • OCT near-infrared optical interference imaging
  • the coaxial rotatable device rotates at high speed and rotates to any sector at the same time
  • the ultrasonic array or optical sensor uses phase control technology or interference scanning to quickly scan the acoustic signals of each point in the sector and real-time feedback. After the computer receives the signal, the images are stitched together to provide information on the inner wall of the surgeon's cavity.
  • the efficiency of converting the ultrasonic transducer array or optical sensor into an image is high, so the position of the cavity wall can be estimated by using the shape of the fixture deployed in the cavity, and from However, the algorithm can be optimized so that the scanning range of the ultrasonic transducer or optical sensor is focused on the vicinity of the cavity wall, thereby reducing the amount of signal sending and receiving and calculation.
  • the operator finds the branch of the lumen concerned, he can finely manipulate the posture of the coaxially rotatable device to see the branch of the lumen and stop, and further control the coincidence of the distal opening with the target branch lumen.
  • the intraluminal fixation device can be a balloon located at the distal end of the catheter that does not affect channel establishment, a memory metal stent such as a nickel-titanium stent, or a multi-link mechanism composed of a hard material with good biocompatibility (titanium alloy or stainless steel). Its driving end is used to deploy the fixation device at the proximal end of the catheter to ensure that the relative position of the distal end of the catheter and the target lumen is fixed.
  • a memory metal stent such as a nickel-titanium stent
  • a multi-link mechanism composed of a hard material with good biocompatibility (titanium alloy or stainless steel).
  • the distal positioning device of the catheter can be made of a radiopaque material or a similar effect can be achieved by spraying a radiopaque material according to the usage scenario and requirements. It can be a set of orthogonally placed coils, or a series of coils that can transmit electrical signals the electrodes. In some scenarios, such as different flow velocities inside the lumen or differences in the basic properties of the substances in the lumen, such as pH value or chemical composition, the specific position of the distal end of the catheter in the lumen can be known by using a matching sensor.
  • the beneficial effect of the invention is that it can greatly reduce the difficulty and complexity of the operation, reduce the use time of DSA, increase the success rate of accurate instrument placement and operation success rate, thereby benefiting patients and doctors.
  • the invention provides a technical solution for detecting the contour of the inner wall of the human body's internal cavity and precisely guiding it into the subdivided branches, including structural design, sensor arrangement, and control and algorithm of supporting catheters.
  • the invention includes ultrasonic and optical sensors, related imaging and navigation algorithms, and a guiding and positioning structure, which are used for real-time detection of the inner wall contour of the human body's internal cavity, and can assist in guiding into the bifurcated cavity.
  • the invention provides a technical means for doctors to conveniently enter into the tiny bifurcations of the patient's venous system.
  • the success rate of doctors operating the guide wire catheter into the target branch vein under the guidance of DSA is 40%-95%, and only a few doctors can achieve a success rate of more than 90%.
  • the success rate of accessing branch veins can reach nearly 100%.
  • the invention does not require doctors to repeatedly insert and pull out the intracavity imaging catheter to provide space for the guide wire catheter, and through the optimization of the algorithm, the demand for product hardware is reduced, and the cost is further reduced compared with the existing intracavity imaging catheter .
  • Fig. 1 is an overall schematic diagram of a product according to an embodiment of the present invention.
  • Fig. 2 is an overall schematic diagram of a part of the catheter according to an embodiment of the present invention.
  • Fig. 3 is a detailed view of a catheter fixing interface according to an embodiment of the present invention.
  • Fig. 4 is a schematic diagram of a converging state of an embodiment of the present invention.
  • Fig. 5 is a schematic diagram of an unfolded state of an embodiment of the present invention.
  • Fig. 6 is a schematic diagram of ultrasonic detection according to an embodiment of the present invention.
  • Figures 7a, 7b and 7c are ultrasonic display images of an embodiment of the present invention.
  • Fig. 8 is a schematic diagram of the rotating part of an embodiment of the present invention.
  • Fig. 9 is a schematic diagram of a rotary encoder according to another embodiment of the present invention.
  • Fig. 10 is a cross-sectional view of an embodiment of the invention in rotation.
  • Fig. 11 is a schematic diagram of a rotating part with a sensor according to another embodiment of the present invention.
  • 12a and 12b are schematic diagrams of the process of detecting the inner wall of a cavity according to an embodiment of the present invention.
  • Fig. 13 is a schematic diagram of a balloon embodiment of an embodiment of the present invention.
  • FIG. 14 is a schematic diagram of a practical operation demonstration 1 of an embodiment of the present invention.
  • Fig. 15 is a schematic diagram of the second practical operation demonstration of an embodiment of the present invention.
  • FIG. 1 is an overall schematic diagram of a product according to an embodiment of the present invention.
  • This embodiment is a specific implementation of an array of ultrasonic transducers uniformly distributed in a ring at the distal end of the catheter.
  • It includes a catheter 1, a rotating part 2, an ultrasonic array 12, a fixing device 13 in the cavity, an adjustable bend catheter 14, a handle 15, a catheter fixing interface and a stator connection end 16, and a rotor part 22.
  • FIG. 2 is an overall schematic diagram of a catheter part according to an embodiment of the present invention.
  • the catheter 1 according to the present invention comprises a catheter fixing interface 18 , an infusion port 17 , a handle 15 , an adjustable bend catheter 14 , an intraluminal fixing module 13 and an ultrasonic array 12 from the proximal end to the distal end.
  • the perfusion port 17 is used to infuse physiological saline mixed with low molecular weight heparin or other anticoagulant suitable for the patient in advance, so as to ensure that no emboli or as few emboli are produced when the catheter 1 is inserted into the patient's body.
  • the handle 15 includes a knob 151 and a slide button 152, wherein the knob 151 drives two high-strength wires embedded in the adjustable bend catheter 14 to drive the bend of the adjustable bend catheter 14, and the slide knob 152 drives the sliding table 132 back and forth along the direction of the catheter axis Move to drive the opening and closing of the intraluminal fixation module 13 .
  • FIG. 3 is a detailed diagram of a catheter fixing interface according to an embodiment of the present invention.
  • the function of the conduit fixing interface 18 is mainly used to fix the rotating part 2, and there is a characteristic port 181 on it, which is matched with the characteristic port of the stator part 23 of the rotating part 2, and is used to provide the only reliable connection direction, aiming at ensuring the connection The direction is uniquely determined.
  • rotating the fixing knob 182 can ensure the stable connection between the rotating part 2 and the stator part 23 .
  • FIG. 4 is a schematic diagram of a converging state according to an embodiment of the present invention.
  • the intraluminal fixation module 13 When the sliding table 132 is closest to the proximal end of the catheter 1, the intraluminal fixation module 13 is in a contracted state, and all parts of the intraluminal fixation module 13 are in a state of being in close contact with the outer wall of the catheter 1, ensuring the passage of the catheter 1 sex.
  • the elastic support 131 of the intraluminal fixation module 13 is made of a superelastic metal material, which can be further constricted when subjected to external extrusion, thereby further improving the passability.
  • the intraluminal fixation module 13 When the slide table 132 slides toward the distal end of the catheter 1, the intraluminal fixation module 13 is deployed, and the support bracket 133 is close to the wall of the lumen, wherein the support bracket 133 can be made of a radiopaque material or a coil is embedded inside to meet the For the detection of electromagnetic signals, the elastic support 131 can ensure that the elastic force around the catheter 1 remains consistent so as to ensure that the axis of the catheter is as consistent as possible with the axis of the lumen.
  • the push distance d1 of the slide table 132 is different from that of the external drive
  • the moving distance of the sliding button 152 is the same, and when the stress of the elastic bracket 131 is greater than a certain value, the elastic bracket 131 will drive the retraction of the sliding table 132 until the stress on the elastic bracket 131 reaches a reasonable range.
  • the specific position of the support bracket 133 can be obtained by externally driving the specific position of the sliding button 152 , so that the current approximate diameter of the inner wall of the lumen can be further obtained.
  • FIG. 6 is a schematic diagram of ultrasonic detection according to an embodiment of the present invention.
  • FIG. 6 shows the specific implementation of the extracatheter ultrasound array 12 in the lumen.
  • the distal end of the catheter 1 includes an extra-catheter ultrasonic array module 12, wherein the ultrasonic transducer group 122 is evenly distributed on the outer wall of the lumen along the circumferential direction. Each of its ultrasonic transducers can send and receive signals independently.
  • the ultrasonic transducer group 122 emits an ultrasonic signal group 123a and another ultrasonic signal group 123b at the same time to detect two points 124a and 124b in the space. Rotate the position of an ultrasound transducer to re-scan the new area, so as to construct the ultrasound image of the section.
  • FIG. 7a, 7b and 7c are ultrasonic display images of an embodiment of the present invention.
  • the ultrasonic catheter probes the lumen 128 and the bifurcation 129 to obtain the image in FIG. 7a.
  • the catheter 1 enters the target lumen through the previously preset sheath channel in a constricted state, and uses in vitro images to detect the intraluminal fixation device 13 at the distal end of the catheter 1 to determine that its position is roughly in the region of interest.
  • the sliding button 152 opens the inner fixing device 13 of the cavity so that it is in close contact with the inner wall of the cavity.
  • Use the ultrasonic transducer group 122 of the catheter 1 to find the bifurcation of interest in the lumen. When the ultrasonic transducer group 122 successfully finds the bifurcation that may be of interest, it starts to drive the rotating part 2 in the catheter. rotor part.
  • FIG. 8 is a schematic diagram of the rotating part of an embodiment of the present invention.
  • the proximal end of the rotating part 2 comprises a set of assembled rotor part 22 and stator part 23 .
  • the stator part 23 and the fixed interface 18 of the catheter 1 are locked and connected to each other and cannot rotate with each other, and the rotor part 22 is connected with the torque transmission tube 24 of the rotating part 2 and cannot rotate with each other, wherein the torque transmission tube 24 can Therefore, the braided tube can also be a hollow flexible shaft, which aims to reliably transmit the rotation of the proximal rotor part 22 to the rotation of the distal side hole 21 .
  • the rotor part 22 rotates coaxially with the stator part 23 and the angle therebetween can be indicated.
  • one implementation is that the origin of the stator part 23 is aligned with a certain group of ultrasonic transducer groups 122 at the distal end of the catheter 1; The holes 21 are aligned with each other; when the image prompts that the angle between the corresponding position of the bifurcation notch and the origin of the ultrasonic transducer group 122 is ⁇ degrees, the alignment can be achieved by rotating the rotor part 22 so that the origin of the rotor part 22 is aligned with the ⁇ degree position. Control of the distal rotor.
  • FIG. 9 is a schematic diagram of a rotary encoder according to another embodiment of the present invention.
  • directly reading the position of the distal end of the rotating part can control the distal side hole 21 more reliably.
  • the rotating part is read by the encoder 25 2 relative to catheter 1.
  • a fixed ultrasonic transducer inside the catheter 1 is defined as the origin, and a signal emission source, such as an optical signal emission source, is placed on the corresponding inner wall of the catheter.
  • the encoder 25 receives the optical signal, it can obtain the current rotating part. 2 specific angles.
  • the rotor part 22 and the stator part 23 can also be the rotor and the stator of a servo motor or a stepping motor, which are controlled by external signals to rotate precisely. See 7(b) and 7(c) in Figure 7 for details on the image.
  • the distal side hole 21 of the rotating part 2 will appear as a notch 125 on the image. By rotating the rotating part 2, the notch 125 is aligned with the detected The bifurcation opening 126 to be reached, that is, the standard distal side hole 21 is aligned with the bifurcation lumen entrance 126 concerned.
  • FIG. 10 shows that by manipulating the rotating part 2 of the present invention, the distal side hole 21 of the rotating part 2 can be precisely aligned with the concerned bifurcation.
  • the distal side hole 21 of the rotating part 2 communicates with the proximal connecting port of the rotating part 2, so that the operator can probe into a microcatheter or a guide wire.
  • the structure in the side hole at the distal end of the rotating part 2 has a guide surface 26 for guiding the guide wire or the microcatheter to protrude from the side hole.
  • Fig. 11 is the rotating part with sensor of another embodiment of the present invention schematic diagram.
  • the rotating part 2 with sensors is placed.
  • the sensor array 32 is placed on the rotating part, and the sensor array 32 is distributed on both sides of the distal side hole 21 along the axial direction, and the radial distribution only covers the distal side hole. twenty one.
  • the sensor array 32 may be a set of ultrasonic arrays, or an infrared optical sensor for detecting the contour of the surrounding inner wall of the rotating part 2 with sensors.
  • Figures 12a and 12b are schematic diagrams of the process of detecting the inner wall of the cavity according to an embodiment of the present invention.
  • the stator 23 is still reliably connected to the fixed interface 18 of the catheter, and the rotor 22 is driven to rotate by the motor, thereby driving the entire rotating part 2 to rotate, while the sensor 32 performs high-speed sampling of the surrounding .
  • Figures 12a and 12b show the process of detecting the inner wall of the cavity.
  • Each signal generator on the sensor array 32 can independently control the emission, by constructing a detection focal point 34 for the time difference of emission.
  • the specific position of the support bracket 133 can be obtained through the specific position of the slide button 152 on the catheter 1, so that the approximate diameter of the inner wall of the lumen can be further obtained, and the diameter of the inscribed circle of the inscribed square of the estimated approximate diameter can be used as the range of interest From the minimum value Ri to the circumscribed circle of the circumscribed square of the estimated diameter as the maximum value Ro of the range of interest can greatly reduce the points of sweeping, thereby reducing the amount of calculation, the area 33 surrounded by the dashed line in Figures 12a and 12b That is, the area is scanned each time.
  • the arrival of the catheter 1 and the rotating part 2 to the region of interest can be estimated by the position of the intraluminal fixation module 13 relative to the patient.
  • Figures 12a and 12b show the case where a fork of interest is detected.
  • the motor controls the rotor 22 to be fixed at the position facing the bifurcation 326, and because in this embodiment, the sensor array 32 is close to the distal side hole 21 of the rotating part 2, so At this time, it can be ensured that the distal side hole 21 of the rotating part 2 is aligned with the bifurcation 326 .
  • the operator can guide the guide wire or microcatheter into the target bifurcation of interest through the connection between the proximal through hole and the distal side hole 21 .
  • FIG. 13 is a schematic diagram of a balloon embodiment of an embodiment of the present invention.
  • another embodiment of the intraluminal fixation device 13 of the embodiment is to use a compliant balloon 137 to perform intraluminal fixation of the catheter 1 by filling and discharging the balloon 137 .
  • the lumen diameter at the location of the catheter can also be estimated through the amount of injected liquid and the change of the pressure inside the balloon 137 .
  • a direct assessment of the diameter of the lumen can be obtained.
  • FIG. 14 is a practical operation demonstration 1 of an embodiment of the present invention.
  • FIG. 14 shows that the catheter enters the lumen 51 in a constricted state.
  • the detection of the ultrasonic array 12 on the catheter forms a large angle with the axis of the lumen, and a stable image cannot be obtained when shaking in the lumen.
  • the axis of the catheter is basically consistent with the axis of the lumen, and the ultrasonic array 12 can detect the concerned bifurcation 52 and stabilize it near it.
  • the rotating part 2 is manipulated so that the distal side hole 21 thereof is aligned with the caring fork 52 , and then the guide wire 53 is inserted into the target caring fork 52 from the distal side hole.
  • FIG. 15 is the second practical operation demonstration of an embodiment of the present invention.
  • FIG. 15( b ) shows that the catheter enters the cavity 51 in a constricted state.
  • the detection of the sensor array 32 on the rotating part forms a large angle with the axis of the cavity, and a stable image cannot be obtained.
  • the sensor array 32 on the rotating part can scan and display the inner wall of the target lumen.
  • the motor is manipulated so that the sensor array 32 is locked and focused on the bifurcated lumen 52, and then the guide wire 53 is passed through the distal side hole 21 directly into the Target fork 52.

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Abstract

一种医用导管(1)，包括近端和远端，远端包括：一个传感器阵列(32)，用于显示腔道(51)内管壁的情况；一个同轴旋转装置，包含一个连通导管(1)近端的通孔，用于建立目标分叉腔道(52)与导管(1)远端的通道；一个腔道内固定装置(13)，用于将导管(1)的远端与腔道(51)内壁相对位置固定，以确保分叉腔道(52)与导管(1)近端建立通道的过程稳定；可以用于探测人体内腔道(51)的结构与分布，同时可以方便引导术者探入目标分叉腔道(52)以满足操作的需求。

Description

一种医用导管 技术领域
本发明涉及医疗器械领域，尤其是一种医用导管。
背景技术
现有介入手术最主要的导航方式是依托DSA(数字剪影技术)在手术过程中，利用X光进行器械的显影，从而辅助术者确定介入器械与患者身体的相对位置关系；同时利用造影剂对周边组织显影、术前影像(CT、MRI、DSA等)比对以及术者经验来确定器械到达的具体位置。
由于DSA的大量使用会使医生与患者长时间暴露在电离辐射下，对医患健康都有隐患。于是近年来，有更多的辅助影像技术被用于介入手术。包括：
1.电磁导航，利用器械上电磁线圈与外界电磁线圈的频率收发时间的匹配来确定体内器械的位置。但是这种方式只能知道器械的空间位置，无法对患者组织直接成像。现在常用于心房内导航，利用导管头端的触感传感器配合电磁线圈，从而利用导管头端接触心房壁的同时记录下空间绝对位置，通过多接触一些心房内点来勾勒出心房轮廓从而建立组织影像。由于心房内壁是凸型包络，所以利用心房内多个点的绝对位置与近似算法可以粗略勾勒出较为精确的心房内壁。但是这种成像方式无法对内壁崎岖，尤其是多分叉的人体内管道进行精确勾勒。
2.心腔内超声，利用超声对心脏进行扇面切片。这种方法可以精确显示声学特征不同的组织和/或器械的轮廓与位置。但是这种方式得到的图像是若干个二维影像的截面，需要术者熟练地构想空间状态来确定器械与组织的相对位置。同时，对超声导管的放置位置与扫描范围也需要术者去调整，较为不方便。由于需要对心腔整体成像清晰，因此超声阵列的传感器数量较大，体积较大，无法用于狭小崎岖的腔道。
3.腔内超声，相较于心腔内超声，腔内超声更多注重与腔壁的组织结构分布，用于指导术者对目标区域的腔道的治疗方式。这导致了它的属性在于着重探测腔内表皮，同时对于它与患者的相对关系依然需要DSA等影像辅助，对于已探测到的分支腔道依然需要医生利用经验与操作去探入。
另一方面，DSA只能在同一时间提供一个方向的投影，对于空间分布的管路的结构无法有个完整的呈现，从而使得探入空间分布的分支管路难度更高。
现在医学上用于动脉系统的导管均使用射线不可透材料或者喷洒射线不可透材料配合数字剪影技术(DSA)进行导管定位。因为动脉血有从粗到细传递的特性，所以可以通过在目标位置附近的主动脉或者分支动脉喷洒射线不可透液体，例如碘海醇，来对目标位置进行显影。但是对于静脉系统来说，由于血是倒流回心脏的，因此在血运系统的静脉主干喷洒显影剂是无法对更细的血管进行显影的。而医生进入静脉系统往往很容易进入静脉系统主干而很难进入静脉系统的分支，尤其是细分支。
因此急需提供一种新的导管设计，用于探测人体内腔道的结构与分布，同时可以方便引导术者探入目标分叉腔道以满足后续操作的需求。
发明内容
本发明的目的在于解决现有医用导管很难进入静脉系统的分支，尤其是细分支的问题，提供了一种新的医用导管设计，用于探测人体内腔道的结构与分布，同时可以方便引导术者探入目标分叉腔道以满足后续操作的需求。
为了实现这一目的本发明提供了一种医用导管，包括有近端和远端，远端包括：
一个传感器阵列，用于显示腔道内管壁的情况；
一个同轴旋转装置，相对导管其他部分可以独立旋转，其上含有连通到导管外部的通孔，用于建立目标分支腔道与导管内部的通道。
一个固定装置，用于将导管的远端与腔道内管壁相对位置固定，以确保目标分支腔道与导管内部建立通道的过程稳定。
其中，传感器阵列可以引导带通孔的旋转部分的远端孔对准所述分叉管路。传感器阵列中的每个单独的传感器单元均可以独立收发信号，即信号属性与发射时间可分别独立控制。传感器阵列可以通过全部显示或部分显示内壁轮廓的方式引导带通孔的同轴旋转装置的通孔对准所述分叉管路。传感器阵列的探测方式可以是环形均匀分布在导管远端也可以是在旋转导管的任意一个扇形区域均有分布。传感器阵列为超声换能器阵列，用于发射与接收超声信号用于探测腔道的内壁轮廓。超声换能器阵列相邻的超声换能器阵列需要先后进行信号的收发，两侧的阵列可以同时收发信号以提高成像的效率。超声换能器阵列能够分辨0.3mm直径的分叉即可满足需求。
传感器阵列也可以为电磁传感器或者光电传感器，用来直接反馈所属的可旋转装置远端相对导管主体的位置信息。传感器阵列也可以为光学传感器，如光学干涉成像、微型广角镜头或激光收发器。
固定装置可以是球囊也可以是弹性支架。固定装置可以是镍钛支架或生物相容性好的硬质材料(钛合金或不锈钢)组成的多连杆机构。固定装置在导管近端有驱动端，可以借助手动或自动的方式驱动固定装置切换状态或产生形变，以实现导管远端和腔道之间相对位置的稳定。
同轴旋转装置的旋转方式可以是手动的也可以是由计算机控制的电机来驱动的。同轴旋转装置相对于导管其他部分可独立旋转，其旋转角度可控制。导管与同轴旋转装置的的近端用可靠的机械结构连接。同轴旋转装置的驱动扭矩可以由导管近端，通过可传递扭矩的软轴相连接，通过控制同轴旋转装置的近端来反馈同轴旋转装置的远端；也可由部署在导管远端的微型电机所提供。同轴旋转装置的近端与远端用可同步旋转的软轴相连接。通过同轴旋转装置的定向旋转，可以转动同轴旋转装置其上的通孔，使其与目标分支腔道在角度上对准，有助于建立孔与目标分支腔道的位置关系。同轴旋转装置与导管的相对角度关系可以通过近端的结构和/或远端的位置传感器组提供相对角度关系。同轴旋转装置与导管的相对角度关系可以实时传出数据指示术者和/或自动化控制系统。同轴旋转装置可以引导微导管或者导丝从导管近端进入，经过导管内腔并从位于导管远端的同轴旋转装置其上的通孔穿出，或者同轴旋转装置可以定向释放预先填充在导管远端的物质，如弹簧圈、管腔栓塞物或药物等以输送至远端分支腔道。
优选的，导管远端可以包含远端定位装置：导管远端可以包含由射线不可透材料构成的也可以通过喷射射线不可透材料以达到在射线下显像的效果；或包含一组正交放置的线圈以达到在磁场中定位的效果；或包含一系列可以传递电信号的电极以达到在电场中定位的效果。前述设计可以实 现术者和/或自动化控制系统判断导管远端相对人体和/或邻近器官的相对位置关系的目的。
该发明的具体实现如下：
a)环状均匀分布在导管远端的超声换能器阵列。在以导管为原点的任意一个扇区内均有一组超声换能器阵列用于发射与接收超声信号用于探测腔道的内壁轮廓。在这种方案下，相邻的超声换能器阵列需要先后进行信号的收发，但是两侧的阵列可以同时收发信号以提高成像的效率，另一方面由于导管直径与超声换能器尺寸的限制，阵列的超声换能器数量会减少，但是由于我们只关心腔道壁的情况，所以分辨率足够分辨0.3mm直径的分叉即可满足需求。在这种设计下，可同轴旋转装置与导管主体共轴可旋转，且它相对于导管主体的旋转位置需要可控制，例如在导管与可同轴旋转装置的近端用可靠的机械连接，可同轴旋转装置的近端与远端用可同步旋转的软轴相连接，通过控制可同轴旋转装置的近端来反馈可旋转装置的远端，尤其是远端的通道建立孔与目标分支腔道的位置关系。又例如使用装置在导管远端的电磁传感器或者光电传感器来直接反馈可旋转装置远端相对导管主体的位置信息。
b)一组直接与可同轴旋转装置相连的超声换能器阵列或者光学传感器例如近红外光学干涉成像(OCT)、微型广角镜头或其他光学干涉成像装置，该阵列扫描的扇区范围覆盖可同轴旋转装置的远端通道口。在导管进入腔道的任意时刻，可同轴旋转装置在高速旋转，同时旋转到任一扇区时，超声阵列或者光学传感器利用相控技术或干涉扫描快速扫描扇区内各点的声学信号并实时反馈。计算机收到信号后拼接图像提供术者腔道内壁的信息。在这种方案下，对于超声换能器阵列或光学传感器转化为图像的效率要求较高，因此利用固定装置在腔道内展开的形态可以预估腔道壁的位置，从 而可以优化算法使得超声换能器或光学传感器的扫描范围着重在腔道壁附近，从而减少了信号收发量与计算量。当术者找到关心的腔道分支时，可以通过精细操控可同轴旋转装置的姿态到看到腔道分支并停止，并进一步控制远端通道口与目标分支腔道重合。
腔道内固定装置可以是一个位于导管远端不影响通道建立的球囊、记忆金属支架如镍钛支架或生物相容性好的硬质材料(钛合金或不锈钢)组成的多连杆机构。其驱动端在导管近端用于展开固定装置以确保导管远端与目标腔道的相对位置固定。
导管的远端定位装置根据使用场景与需求，可以是由射线不可透材料构成或者通过喷射射线不可透材料达到类似效果，可以是一组正交放置的线圈，也可以是一系列可以传递电信号的电极。在某些场景下，例如所在管腔的内部各处流速不同或者腔道内物质的基础性质例如pH值或者化学成分的不同，利用匹配的传感器可以知道导管远端在腔道内的具体位置。
本发明的有益效果是可以极大降低手术难度与复杂度，减少DSA的使用时间，增加器械准确到位成功率和手术成功率，从而让患者与医生受益。本发明提供了一种用于人体内腔道内壁轮廓的探查与精确引导进入细分叉支的技术方案，包括结构设计、传感器布置与配套导管的控制与算法。本发明包含超声与光学传感器，相关成像与导航算法与引导定位结构，用于实时探测人体内腔道的内壁轮廓，同时可以辅助引导进入分叉腔道。
本发明为医生提供了一种方便进入患者静脉系统的细小分叉的技术手段。目前医生操作导丝导管在DSA引导下进入目标分支静脉的成功率为40％-95％，仅有少数医生能做到90％以上成功率。通过本发明，进入分支静脉的成功率能达到接近100％。
另一方面，相比于一些医生使用现有的腔内影像导管与导丝导管联用来解决类似问题的情况。本发明不需要医生反复插拔腔内影像导管来为导丝导管提供空间，且通过对算法的优化，实现对产品硬件需求的降低，进一步实现成本相较现有的腔内影像导管是减少的。
为使本发明的上述目的、特征和优点能更明显易懂，下文特举较佳实施例，并配合所附附图，作详细说明如下。
附图说明
为了更清楚地说明本发明具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本发明的一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本发明的一个实施例的产品整体示意图。
图2为本发明的一个实施例的导管部分整体示意图。
图3为本发明的一个实施例的导管固定接口详细图。
图4为本发明的一个实施例的收束态示意图。
图5为本发明的一个实施例的展开态示意图。
图6为本发明的一个实施例的超声探测示意图。
图7a、7b、7c为本发明的一个实施例的超声显示图像。
图8为本发明的一个实施例的旋转部分示意图。
图9为本发明的另一个实施例的旋转编码器示意图。
图10为本发明的一个实施例的旋转部分剖面图。
图11为本发明的另一个实施例的带传感器的旋转部分示意图。
图12a和12b为本发明的一个实施例的探测腔道内壁的过程示意图。
图13为本发明的一个实施例的球囊实施例示意图。
图14为本发明的一个实施例的实际操作演示一的示意图。
图15为本发明的一个实施例的实际操作演示二的示意图。
具体实施方式
下面将结合本发明实施例中附图，对本发明实施例中的技术方案进行清楚、完整的描述。显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。通常在此处附图中描述和示出的本发明实施例的组件可以以各种不同的配置来布置和设计。因此，以下对在附图中提供的本发明的实施例的详细描述并非旨在限制要求保护的本发明的范围，而是仅仅表示本发明的选定实施例。基于本发明的实施例，本领域技术人员在没有做出创造性劳动的前提下所获得的所有其他实施例，都属于本发明保护的范围。
下面对本发明做进一步的详细说明，以令本领域技术人员参照说明文字能够据以实施。
首先请参照图1，图1为本发明的一个实施例的产品整体示意图。该实施例是环状均匀分布在导管远端的超声换能器阵列的具体实施。在图1中， 包含导管1，旋转部分2，超声阵列12，腔道内固定装置13，可调弯导管14，手柄15，导管固定接口与定子连接端16，转子部分22。
接下来请参阅图2，图2为本发明的一个实施例的导管部分整体示意图。本发明所述的导管1，其自近端至远端包括导管固定接口18、灌注口17、手柄15、可调弯导管14、管腔内固定模块13与超声阵列12。灌注口17用于提前灌注混有低分子肝素或者别的适用于患者的抗凝剂的生理盐水，确保导管1插入患者体内时不产生栓子或者尽可能少产生栓子。手柄15包含旋钮151与滑钮152，其中旋钮151驱动2根埋入可调弯导管14的高强度丝线以驱动可调弯导管14的弯曲、滑钮152驱动滑台132沿着导管轴线方向前后移动来驱动管腔内固定模块13的张开闭合。
再请参阅图3，图3为本发明的一个实施例的导管固定接口详细图。其中导管固定接口18的作用主要用于固定旋转部分2，其上有一个特征口181，与旋转部分2的定子部分23的特征口匹配连接，用于提供唯一可靠的连接方向，旨在确保连接方向唯一确定。当旋转部分2与定子部分23连接后，旋转固定旋钮182即可确保旋转部分2与定子部分23的稳固连接。
再请参阅图4与图5，图4为本发明的一个实施例的收束态示意图。当滑台132在最靠近导管1近端的时候，管腔内固定模块13呈现收束态，管腔内固定模块13的各部分均呈现紧贴导管1的外壁的状态，确保导管1的通过性。其中管腔内固定模块13的弹性支架131为超弹性金属材料，受到外部挤压时可以进一步收束从而进一步提高通过性。随着滑台132向导管1的远端滑动时，管腔内固定模块13展开，支撑支架133紧贴管腔壁，其中支撑支架133可以是射线不可透材料制成或者内部嵌有线圈以满足电磁信号的探测，弹性支架131能确保导管1周围的弹力保持一致从而确保导管轴线尽可能与管腔的轴线一致。另外，滑台132的推送距离d1与外部驱动 的滑钮152的移动距离一致，且当弹性支架131的应力大于一定值时，弹性支架131会驱动滑台132的回撤直至弹性支架131上应力到达合理范围内。这样，通过外部驱动滑钮152的具体位置即可获得支撑支架133的具体位置，从而进一步可以获得现在管腔的内壁的大约直径。
再请参阅图6，图6为本发明的一个实施例的超声探测示意图。图6展示了导管外超声阵列12在管腔内的具体实现。导管1远端包含导管外超声阵列模块12，其中超声换能器组122沿圆周方向均匀分布在管腔的外壁。其每一块超声换能器均可独立收发信号。超声换能器组122同一时刻发射了超声信号组123a与另一组超声信号组123b用于探测空间中两点124a与124b，当两组超声阵列分别扫描完所在区域后，顺时针或者逆时针旋转一个超声换能器位置重新对新的区域进行扫描，从而构建出所在截面的超声影像。
图7a、7b、7c为本发明的一个实施例的超声显示图像。在本实施例中，超声导管探测管腔128与分叉129，便可得到图7a中的图像。具体使用时，导管1呈现收束态通过之前预设的鞘管通道进入目标管腔，使用体外影像对导管1远端的腔道内固定装置13进行探测确定其位置在大致感兴趣的区域，驱动滑钮152张开腔道内固定装置13，使之与腔道内壁紧贴。使用导管1的超声换能器组122在管腔内找目标感兴趣的分叉，当超声换能器组122成功找到了可能感兴趣的分叉时，则开始驱动导管内的旋转部分2的转子部分。
再请参阅图8，图8为本发明的一个实施例的旋转部分示意图。旋转部分2的近端包含一组已装配在一起的转子部分22与定子部分23。定子部分23与导管1的固定接口18互相锁紧连接且不可互相转动，转子部分22与旋转部分2的扭矩传递管24连接且不可互相转动，其中扭矩传递管24可 以是编织管也可以是空心软轴，旨在可靠传递近端转子部分22的转动给远端侧孔21的转动。转子部分22与定子部分23同轴转动且可以指示两者之间的角度。在本发明中，一种实现方式是定子部分23的原点与导管1的远端的超声换能器组122中确定的一组互相对齐；同时转子部分22的原点与旋转部分2远端的侧孔21互相对齐；当图像提示分叉缺口对应位置与超声换能器组122的原点的夹角为α度，则可以通过旋转转子部分22使得转子部分22的原点对准α度位置从而达成对远端转子的控制。
再请参阅图9，图9为本发明的另一个实施例的旋转编码器示意图。该实施例中，直接对旋转部分远端的位置进行读取可以更可靠地操控远端侧孔21，旋转部分2的远端与导管1的远端匹配后，通过编码器25读取旋转部分2与导管1的相对位置。在导管1内部的某一个固定的超声换能器下定义为原点，在其对应的导管内壁安置一个信号发射源，例如光信号发射源，编码器25收到光信号之后即可获取现在旋转部分2的具体角度。所述转子部分22与定子部分23也可以是伺服电机或者步进电机的转子与定子，通过外部信号的控制来精确旋转。在图像上的具体体现见图7的7(b)与7(c)，旋转部分2的远端侧孔21会在图像上体现为缺口125，通过旋转旋转部分2使得缺口125对准所探测到的分叉口126即标准远端侧孔21与所关心的分叉腔道口126对齐。
再请参阅图10，图10为本发明的通过对旋转部分2的操控，可以使得旋转部分2的远端侧孔21精确对准所述关心的分叉。旋转部分2的远端侧孔21与旋转部分2的近端连接口连通，使得术者可以探入微导管或者导丝。旋转部分2的远端侧孔内结构有一个导向面26用于引导导丝或者微导管从侧孔中探出。
再请参阅图11，图11为本发明的另一个实施例的带传感器的旋转部分 示意图。如图11所示为带传感器的旋转部分2，将传感器阵列32放置于旋转部分，且传感器阵列32分布在远端侧孔21的沿轴向两侧，且径向分布仅覆盖远端侧孔21。所述的传感器阵列32可以是一组超声阵列，也可以是红外光学传感器用于探测所述带传感器的旋转部分2的周围内壁的轮廓。
再请参阅图12a和12b，图12a和12b为本发明的一个实施例的探测腔道内壁的过程示意图。如图12a和12b所示，在这种实施例下，定子23与导管的固定接口18依然可靠连接，转子22由电机驱动旋转，从而带动整个旋转部分2旋转，同时传感器32对周围进行高速采样。图12a和12b展示了探测腔道内壁的过程，传感器阵列32上每个信号发生器都可以独立控制发射，通过对发射的时间差构造一个探测聚焦点34.由于图像由传感器阵列32实时获取，同时传感器阵列32在旋转，因此图像获取效率要求更高。通过导管1上滑钮152的具体位置即可获得支撑支架133的具体位置，从而进一步可以获得现在管腔的内壁的大约直径，由所估计大约直径的内接正方形的内切圆直径作为兴趣范围的最小值Ri到所估计大约直径的外切正方形的外接圆作为兴趣范围的最大值Ro即可极大减少扫略的点，从而减少计算量，所述图12a和12b虚线所围的区域33即每次扫略区域。
同样地，通过管腔内固定模块13相对于患者的位置可以预估导管1与旋转部分2到达感兴趣的区域。通过旋转部分2的探测来寻找感兴趣的分叉。如图12a和12b，显示了探测到感兴趣分叉的情况。当传感器阵列32探测到分叉326，电机控制转子22定在正对分叉326的位置，又因为在这个实施例中，传感器阵列32与旋转部分2的远端侧孔21是相近的，所以此时可以确保旋转部分2的远端侧孔21与分叉326是对准的。同理，术者可以通过近端通孔与远端侧孔21的连通性来引导导丝或者微导管进入目标感兴趣的分叉。
再请参阅图13，图13为本发明的一个实施例的球囊实施例示意图。
如图13所示，实施例的腔道内固定装置13的另一个实施方案是利用顺应性球囊137，通过对球囊137的充放来进行导管1的管腔内固定。进一步，通过注入液体量与球囊137内压力的变化同样可以对导管所在位置的腔道直径有个预估。在某些实际操作中，通过使用射线不可透液体对球囊137进行充盈，即可对腔道的直径有个直接的评估。
再请参阅图14，图14为本发明的一个实施例的实际操作演示一。
如图14，图14中(a)是导管呈现收束态进入腔道51，此时导管上超声阵列12的探测与腔道的轴线呈较大夹角，且在腔道中晃动无法获取稳定图像。通过腔道内固定装置13的展开，如图14中(b)所示，导管轴线与腔道轴线基本一致，超声阵列12对所述的关心分叉52可以探测到且稳定在其附近。对旋转部分2进行操控，使得其远端侧孔21对准关心分叉52，然后将导丝53从远端侧孔探入目标关心分叉52。
再请参阅图15，图15为本发明的一个实施例的实际操作演示二。
如图15，图15中(a)是导管呈现收束态进入腔道51，此时旋转部分上传感器阵列32的探测与腔道的轴线呈较大夹角，无法获取稳定图像。通过腔内固定装置13的展开，如图15中(b)所示，此时旋转部分上传感器阵列32可以对目标腔道的内壁进行扫描显示。当确认所看到的分叉腔道是目标分叉腔道52时，操控电机使得传感器阵列32锁定聚焦在分叉腔道52上，然后直接将导丝53穿过其远端侧孔21进入目标分叉52。
尽管本发明的实施方案已公开如上，但其并不仅仅限于说明书和实施方式中所列运用。它完全可以被适用于各种适合本发明的领域。对于熟悉本领域的人员而言可以容易实现另外的修改。因此在不背离权利要求及等 同范围所限定的一般概念下，本发明并不限于特定的细节和这里展示和描述的图例。

Claims (27)

  1. 一种医用导管，包括有近端和远端，其特征在于远端包括：
    一个传感器阵列，用于显示腔道内管壁的情况；
    一个同轴旋转装置，相对导管其他部分可以独立旋转，其上含有连通到导管外部的通孔，用于建立目标分支腔道与导管内部的通道；
    一个固定装置，用于将导管的远端与腔道内壁相对位置固定，以确保目标分支腔道与导管内部建立通道的过程稳定；
    所述传感器阵列可以引导带通孔的旋转部分的远端孔对准所述分叉管路。
  2. 如权利要求1所述的一种医用导管，所述的传感器阵列中的每个单独的传感器单元均可以独立收发信号，即信号属性与发射时间可分别独立控制。
  3. 如权利要求1所述的一种医用导管，所述的传感器阵列可以通过全部显示内壁轮廓的方式引导带通孔的同轴旋转装置的通孔对准所述分叉管路。
  4. 如权利要求1所述的一种医用导管，所述的传感器阵列可以通过部分显示内壁轮廓的方式引导带通孔的旋转部分的远端孔对准所述分叉管路。
  5. 如权利要求1所述的一种医用导管，所述的传感器阵列的探测方式可以是环形均匀分布在导管远端的。
  6. 如权利要求1所述的一种医用导管，所述的传感器阵列的探测方式可以是旋转导管的任意一个扇形区域均有分布。
  7. 如权利要求1所述的一种医用导管，所述的传感器阵列为超声换能器阵列，用于发射与接收超声信号用于探测腔道的内壁轮廓。
  8. 如权利要求7所述的一种医用导管，所述的超声换能器阵列相邻的超声换能器阵列需要先后进行信号的收发，两侧的阵列可以同时收发信号以提高成像的效率。
  9. 如权利要求7所述的一种医用导管，所述的超声换能器阵列能够分辨0.3mm直径的分叉即可满足需求。
  10. 如权利要求1所述的一种医用导管，所述的传感器阵列为电磁传感器或者光电传感器，用来直接反馈所属的可旋转装置远端相对导管主体的位置信息。
  11. 如权利要求1所述的一种医用导管，所述的传感器阵列为光学传感器。
  12. 如权利要求1所述的一种医用导管，所述的固定装置可以是球囊。
  13. 如权利要求1所述的一种医用导管，所述的固定装置可以是弹性支架。
  14. 如权利要求1所述的一种医用导管，所述的固定装置可以是镍钛支架或生物相容性好的硬质材料(钛合金或不锈钢)组成的多连杆机构。
  15. 如权利要求1所述的一种医用导管，所述的固定装置在导管近端有驱动端，可以借助手动或自动的方式驱动固定装置切换状态或产生形变，以实现导管远端和腔道之间相对位置的稳定。
  16. 如权利要求1所述的一种医用导管，所述的同轴旋转装置的旋转方式可以是手动的。
  17. 如权利要求1所述的一种医用导管，所述的同轴旋转装置的旋转方式可以是由计算机控制的电机来驱动的。
  18. 如权利要求1所述的一种医用导管，所述的同轴旋转装置相对于导管其他部分可独立旋转，其旋转角度可控制。
  19. 如权利要求1所述的一种医用导管，所述的同轴旋转装置，导管与可同轴旋转装置的的近端用可靠的机械结构连接，同轴旋转装置的近端与 远端用可同步旋转的软轴相连接，通过同轴旋转装置的定向旋转，可以转动同轴旋转装置其上的通孔，使其与目标分支腔道在角度上对准，有助于建立孔与目标分支腔道的位置关系。
  20. 如权利要求1所述的一种医用导管，所述的同轴旋转装置与导管的相对角度关系可以通过近端的结构和/或远端的位置传感器组提供相对角度关系。
  21. 如权利要求1所述的一种医用导管，所述的同轴旋转装置与导管的相对角度关系可以实时传出数据指示术者。
  22. 如权利要求1所述的一种医用导管，所述的同轴旋转装置可以引导微导管或者导丝从近端入口穿出远端通孔。
  23. 如权利要求1所述的一种医用导管，所述的导管的远端可以包含远端定位装置。
  24. 如权利要求23所述的一种医用导管，所述的导管的远端定位装置可以是由射线不可透材料构成的。
  25. 如权利要求23所述的一种医用导管，所述的导管的远端定位装置可以通过喷射射线不可透材料达到需要的效果。
  26. 如权利要求23所述的一种医用导管，所述的导管远端的定位装置可以是一组正交放置的线圈。
  27. 如权利要求23所述的一种医用导管，所述的导管的远端定位装置可以是一系列可以传递电信号的电极。
PCT/CN2023/072522 2022-02-22 2023-01-17 一种医用导管 WO2023160306A1 (zh)

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