Medical Catheters

Abstract

The medical catheter (1) includes a proximal end and a distal end, and the distal end includes a sensor array (32) for displaying the condition of the inner wall of the lumen (51), a coaxial rotation device including a through hole communicating with the proximal end of the catheter (1) for establishing a passage between a target branch lumen (52) and the distal end of the catheter (1), and an intraluminal fixation device (13) for fixing the relative position between the distal end of the catheter (1) and the inner wall of the lumen (51) to ensure the stability of the passage establishment process between the branch lumen (52) and the proximal end of the catheter (1), so that the medical catheter (1) can detect the structure and distribution of the lumen (51) in the human body and easily guide the surgeon to insert into the target branch lumen (52) to meet the needs of the operation.

Description

[Technical field]

[0001] The present invention relates to the field of medical devices, and in particular to medical catheters. [Background technology]

[0002] The most common navigation method in conventional interventional surgery is based on DSA (digital subtraction angiography), which uses X-rays to take images of the instruments during surgery to help the surgeon determine the relative positional relationship between the interventional instruments and the patient's body. This navigation method uses contrast media to take images of the surrounding tissues, and determines the specific position where the instruments will reach by comparing them with preoperative images (CT, MRI, DSA, etc.) and using the surgeon's experience.

[0003] The extensive use of DSA exposes doctors and patients to ionizing radiation for a long time, which may pose potential risks to their health. Therefore, more and more auxiliary imaging techniques are being used in interventional surgery in recent years. The auxiliary imaging techniques include electromagnetic navigation, intracardiac ultrasound, and intracavitary ultrasound.

[0004] 1. In electromagnetic navigation, the position of the instrument inside the body is determined by matching the frequency transmission and reception time between the instrument's electromagnetic coil and the external electromagnetic coil. However, this method can only know the spatial position of the instrument, and cannot directly image the patient's tissue. Currently, it is commonly used for intra-atrial navigation, and by combining a touch sensor at the tip of the catheter with an electromagnetic coil, the spatial absolute position is recorded when the catheter tip is in contact with the atrial wall, and the atrial contour is drawn by touching multiple points in the atrium to create a tissue image. Since the atrial inner wall is a convex envelope, the exact atrial inner wall can be roughly drawn by using the absolute positions of multiple points in the atrium and an approximation algorithm. However, this imaging method cannot accurately depict the uneven parts of the inner wall, especially the multi-branched tubes in the human body.

[0005] 2. Intracardiac ultrasound examination uses ultrasound to scan in a sector shape to show a cross section of the heart. This method can accurately display the contours and positions of tissues and / or instruments with different acoustic properties. However, the images obtained by this method are cross sections of multiple two-dimensional images, and the surgeon must be skilled in imaging the spatial state to determine the relative positions of the instruments and tissues. In addition, the surgeon must adjust the placement position and scanning range of the ultrasound catheter, which is inconvenient. Since it is necessary to clearly image the entire heart cavity, the ultrasound array has many sensors and a large volume, making it impossible to use in narrow and uneven cavities.

[0006] 3. Compared with intracardiac ultrasound, intraluminal ultrasound focuses on the distribution of tissue structure of the luminal wall, and guides the surgeon in the treatment method of the target area. Therefore, although intraluminal ultrasound focuses on the detection of the luminal epithelium, image assistance such as DSA is still required for the relationship with the patient. And for the detected branch lumen, the doctor still needs to use his experience and skill to insert it.

[0007] On the other hand, DSA can only provide one-way projection at a time and cannot fully display the spatially distributed vascular structure, which makes it more difficult to insert into the spatially distributed branching ducts.

[0008] Currently, all catheters used in the arterial system in medicine are positioned using radiopaque materials or sprayed with radiopaque materials in combination with digital subtraction angiography (DSA). Since arterial blood has the characteristic of flowing from large blood vessels to small blood vessels, the target location can be imaged by spraying a radiopaque liquid such as iohexol on the aorta or branch arteries near the target location. However, in the case of the venous system, blood returns to the heart, so it is not possible to spray a contrast agent on the venous trunk of the blood circulation system to image the smaller blood vessels. When a doctor enters the venous system, it is generally easy to enter the venous trunk, but it is difficult to enter the venous branch, especially the small branch.

[0009] Therefore, there is an urgent need to provide a new catheter design that can detect the structure and distribution of lumens in the human body and easily guide the surgeon to insert into the target branched lumens to meet the needs of subsequent operations. Summary of the Invention [Problem to be solved by the invention]

[0010] In order to solve the problem that conventional medical catheters have difficulty entering branches of the venous system, especially small branches, the present invention aims to provide a new medical catheter design that can detect the structure and distribution of lumens in the human body, and easily guide the surgeon to insert into the target branch lumen to meet the needs of subsequent operations. [Means for solving the problem]

[0011] To this end, the present invention provides a medical catheter including a proximal end and a distal end, the distal end comprising: a sensor array for displaying the condition of the inner wall of the lumen; a coaxial rotation device that is rotatable independently of other portions of the catheter and includes a through hole communicating with the exterior of the catheter for establishing a passage between the target branch lumen and the interior of the catheter; and a fixing device for fixing the relative position between the distal end of the catheter and the inner lumen wall to ensure stability in the process of establishing a passage between the target branch lumen and the inside of the catheter.

[0012] The sensor array can guide the distal end hole of the rotating part having a through hole to match the branched pipeline. Each single sensor unit in the sensor array can transmit and receive signals independently, that is, the signal attributes and transmission times can be controlled independently. The sensor array can guide the through hole of the coaxial rotating device having a through hole to match the branched pipeline by fully displaying or partially displaying the inner wall contour. The sensor array can be uniformly distributed in a ring shape at the distal end of the catheter for detection, or can be distributed in any fan-shaped area of ​​the rotating catheter. The sensor array is an ultrasonic transducer array that transmits and receives ultrasonic signals to detect the inner wall contour of the lumen. The ultrasonic transducer array adjacent to the ultrasonic transducer array needs to transmit and receive signals in a back-and-forth manner, and the arrays on both sides can transmit and receive signals simultaneously to improve imaging efficiency. The ultrasonic transducer array only needs to identify a branch with a diameter of 0.3 mm to meet the needs.

[0013] The sensor array may be an electromagnetic or photoelectric sensor that directly feeds back position information of the distal end of the associated rotatable device relative to the catheter body, or the sensor array may be an optical sensor such as an optical coherence imager, a miniature wide-angle lens, or a laser transceiver.

[0014] The fixation device may be a balloon or an elastic stent. The fixation device may be a Nitinol stent or a multi-link mechanism made of a hard material (titanium alloy or stainless steel) that is highly biocompatible. The fixation device has a drive end at the proximal end of the catheter and can be driven in a manual or automatic manner to switch states or deform in order to achieve relative positional stability between the distal end of the catheter and the lumen.

[0015] The coaxial rotation device may be rotated manually or by a computer-controlled motor. The coaxial rotation device is rotatable independently of the other parts of the catheter, and the rotation angle is controllable. The proximal end of the catheter and the coaxial rotation device are connected by a reliable mechanical structure. The driving torque of the coaxial rotation device may be fed back to the distal end of the coaxial rotation device by controlling the proximal end of the coaxial rotation device from the proximal end of the catheter connected by a flexible shaft capable of transmitting torque, or may be provided by a micromotor disposed at the distal end of the catheter. The proximal and distal ends of the coaxial rotation device are connected by a flexible shaft capable of synchronous rotation. The directional rotation of the coaxial rotation device rotates the through hole of the coaxial rotation device so as to align the angle with the target branch lumen, which helps to establish the positional relationship between the through hole and the target branch lumen. The relative angular relationship between the coaxial rotation device and the catheter can be provided by a structure at the proximal end and / or a group of position sensors at the distal end. Data on the relative angular relationship between the coaxial rotation device and the catheter can be transmitted in real time to indicate to the surgeon and / or an automatic control system. The coaxial rotation device can guide a microcatheter or guidewire through the cavity of the catheter at the proximal end of the catheter and through the through-hole of the coaxial rotation device at the distal end of the catheter, or the coaxial rotation device can directionally release and deliver a substance preloaded at the distal end of the catheter, such as a coil embolic material, a lumen embolic material or a drug, to a branch lumen at the distal end.

[0016] Preferably, the distal end of the catheter may include a distal end localization device. The distal end of the catheter may include one constructed of a radiopaque material, may be sprayed with radiopaque material to achieve a radiation-developing effect, may include a set of orthogonally arranged coils to achieve a magnetic field localization effect, or may include a series of electrodes capable of transmitting electrical signals to achieve an electric field localization effect. The above design allows the operator and / or an automated control system to achieve the goal of determining the relative position of the distal end of the catheter to the human body and / or nearby organs.

[0017] A specific embodiment of the present invention is as follows.

[0018] a) The ultrasonic transducer arrays are uniformly distributed in a ring shape at the distal end of the catheter. In any sector area originating from the catheter, there is a pair of ultrasonic transducer arrays that transmit and receive ultrasonic signals to detect the inner wall contour of the lumen. In such a solution, adjacent ultrasonic transducer arrays need to transmit and receive signals sequentially, but the arrays on both sides can transmit and receive signals simultaneously, which can improve imaging efficiency. Meanwhile, the number of ultrasonic transducers in the array is reduced due to limitations in the catheter diameter and the ultrasonic transducer size. However, since we are only interested in the condition of the lumen wall, if a branch with a diameter of 0.3 mm can be sufficiently identified (with sufficient resolution), it will meet our needs. In such a design, the coaxial rotatable device must be rotatable coaxially with the catheter body, and its rotational position relative to the catheter body must be controllable. For example, the catheter and the proximal end of the coaxial rotatable device are connected with a reliable mechanical connection, and the proximal end and distal end of the coaxial rotatable device are connected with a flexible shaft that can rotate synchronously. The proximal end of the coaxial rotatable device is controlled to feedback the positional relationship between the distal end of the rotatable device, particularly the passage-establishing through-hole at the distal end and the target branch lumen, or, for example, an electromagnetic or photoelectric sensor at the distal end of the device's catheter directly feedbacks positional information of the distal end of the rotatable device relative to the catheter body.

[0019] b) A set of ultrasonic transducer arrays or optical sensors such as near-infrared optical coherence imaging (OCT) devices, small wide-angle lenses or other optical coherence imaging devices are directly connected to the coaxially rotatable device, and the range of the sector area scanned by the eye covers the passage opening at the distal end of the coaxially rotatable device. At any time when the catheter enters the lumen, the coaxially rotatable device rotates at high speed and rotates to any sector area, and the ultrasonic array or optical sensor uses phase control technology or coherence scanning to rapidly scan the acoustic signals of each point in the sector area and feedback in real time. After receiving the signal, the computer synthesizes the image to provide the operator with information on the inner wall of the lumen. In this solution, since there is a high requirement for the efficiency of image conversion by the ultrasonic transducer array or optical sensor, the position of the lumen wall can be predicted according to the deployed shape of the fixed device in the lumen. Therefore, the algorithm can be optimized to concentrate the scanning range of the ultrasonic transducer or optical sensor near the lumen wall, thereby reducing the amount of signal transmission and reception and the amount of calculation. Once the surgeon finds a branch of a lumen of interest, he or she can precisely manipulate the orientation of the coaxially rotatable device until the branch of the lumen is visible, and then control the passage opening at the distal end to overlap the target branch lumen.

[0020] The intraluminal fixation device is at the distal end of the catheter and may be a balloon that does not affect the establishment of the passageway, a shape memory alloy stent such as a Nitinol stent, or a multi-link mechanism made of a hard material (titanium alloy or stainless steel) with excellent biocompatibility, the driving end of which deploys 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.

[0021] The catheter distal end localization device may be made of radiopaque material or may spray radiopaque material to achieve a similar effect, depending on the scene and needs of use. It may also be a set of coils arranged orthogonally, or a set of electrodes capable of transmitting electrical signals. In certain scenes, for example, when the flow rate is different at each point inside the lumen, or when the basic properties such as pH value or chemical composition of the substance inside the lumen are different, the specific position of the distal end of the catheter inside the lumen can be known by using a matching sensor. Effect of the Invention

[0022] The beneficial effect of the present invention is to benefit patients and doctors by significantly reducing the difficulty and complexity of surgery, reducing the time of using DSA, and improving the success rate of the instrument reaching the intended position accurately and the success rate of surgery. The present invention provides a technical means for detecting the contour of the inner wall of a lumen in the human body and accurately guiding it to enter a narrow branch, including the structure design, sensor placement and associated catheter control and algorithm. The present invention includes ultrasonic and optical sensors, related imaging and navigation algorithms, and a guidance and positioning structure (guiding and positioning structure), which can detect the contour of the inner wall of a lumen in the human body in real time and assist in guiding it to enter a branch lumen.

[0023] The present invention provides physicians with a technical means to easily access small branches of a patient's venous system. Currently, the success rate of physicians manipulating a catheter with a guidewire to access a target branch vein using DSA is 40%-95%, with very few physicians achieving a success rate of 90%. With the present invention, the success rate of accessing a branch vein approaches 100%.

[0024] On the one hand, compared with the case where some physicians use a conventional intraluminal imaging catheter in combination with a catheter with a guidewire to solve similar problems, in the present invention, the physician does not need to repeatedly insert and remove the intraluminal imaging catheter to make space for the catheter with a guidewire, and by optimizing the algorithm, the requirements for product hardware are reduced, and the cost is further reduced compared with that of the conventional intraluminal imaging catheter.

[0025] In order to make the above objects, features and advantages of the present invention clearer and more comprehensible, preferred embodiments of the present invention will be described in detail below with reference to the drawings. [Brief description of the drawings]

[0026] In order to more clearly describe the specific embodiments of the present invention or the technical means in the prior art, the drawings necessary for describing the specific embodiments or the prior art will be briefly described below. Obviously, the drawings described below are only some embodiments of the present invention, and those skilled in the art can obtain other drawings based on these drawings without any creative work.

[0027] [Figure 1] 1 is a schematic diagram of an overall product of one embodiment of the present invention; [Diagram 2] 1 is a schematic diagram of an entire catheter portion of one embodiment of the present invention; [Diagram 3] FIG. 2 is a detailed view of a catheter securement connector according to one embodiment of the present invention. [Figure 4] FIG. 2 is a schematic diagram of an embodiment of the present invention in a contracted state. [Diagram 5] FIG. 2 is a schematic diagram of an embodiment of the present invention in an unfolded state. [Figure 6] FIG. 2 is a schematic diagram of ultrasonic detection according to one embodiment of the present invention. [Figure 7a] 1 is an ultrasound display image of one embodiment of the present invention. [Figure 7b] 1 is an ultrasound display image of one embodiment of the present invention. [Figure 7c] 1 is an ultrasound display image of one embodiment of the present invention. [Figure 8] FIG. 2 is a schematic diagram of a rotating part according to one embodiment of the present invention. [Figure 9] FIG. 4 is a schematic diagram of a rotary encoder according to another embodiment of the present invention. [Figure 10] FIG. 2 is a cross-sectional view of a rotating portion according to an embodiment of the present invention. [Figure 11] FIG. 13 is a schematic diagram of a rotating section with a sensor according to another embodiment of the present invention. [Figure 12a] FIG. 2 is a schematic diagram showing a process for detecting an inner luminal wall in one embodiment of the present invention. [Figure 12b] FIG. 2 is a schematic diagram showing a process for detecting an inner luminal wall in one embodiment of the present invention. [Figure 13] 1 is a schematic diagram of an embodiment of a balloon according to one embodiment of the present invention. [Figure 14] FIG. 1 is a schematic diagram of an actual operation demonstration 1 of an embodiment of the present invention. [Figure 15] FIG. 2 is a schematic diagram of an actual operation demonstration 2 of an embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] Hereinafter, the technical means in the embodiments of the present invention will be described clearly and completely with reference to the drawings in the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, but not all embodiments. Typically, the components of the embodiments of the present invention described and shown in the drawings of this specification may be arranged and designed in various configurations. Therefore, the detailed description of the embodiments of the present invention provided below in the drawings is not intended to limit the scope of the claimed invention, but represents only selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative labor are within the protection scope of the present invention.

[0029] The present invention will now be described in more detail, so that those skilled in the art can practice the invention by referring to the specification.

[0030] Figure 1 is a schematic diagram of the whole product of one embodiment of the present invention. As shown in Figure 1, the embodiment is a specific implementation of an ultrasonic transducer array uniformly distributed in a ring shape at the distal end of a catheter. In Figure 1, the catheter includes a catheter 1, a rotating part 2, an ultrasonic array 12, an intraluminal fixation device 13, a catheter curved part 14, a handle 15, a connection end 16 between the catheter fixation connector and the stator part, and a rotor part 22.

[0031] FIG. 2 is a schematic diagram of the entire catheter section of one embodiment of the present invention. As shown in FIG. 2, the catheter 1 of the present invention includes, from the proximal end to the distal end, a catheter fixing connector 18, an inlet 17, a handle 15, a catheter bending section 14, an intraluminal fixing module 13, and an ultrasound array 12. The inlet 17 is used to inject saline mixed with low molecular weight heparin or another anticoagulant suitable for the patient early so as to generate no emboli or as few emboli as possible when the catheter 1 is inserted into the patient's body. The handle 15 includes a knob 151 and a slide button 152. The knob 151 drives two high-strength wires embedded in the catheter bending section 14 to drive the bending of the catheter bending section 14. The slide button 152 drives the slide table 132 to move back and forth along the axial direction of the catheter, thereby driving the opening and closing of the intraluminal fixing module 13.

[0032] 3 is a detailed view of the catheter fixing connector of one embodiment of the present invention. As shown in FIG. 3, the role of the catheter fixing connector 18 is mainly to fix the rotating part 2, and the catheter fixing connector 18 is provided with a feature port 181, which is connected to the feature port of the stator part 23 of the rotating part 2 to provide a unique and reliable connection direction, and ensure that the connection direction is unique and specific. After the rotating part 2 is connected to the stator part 23, the fixing knob 182 can be rotated to ensure a stable connection between the rotating part 2 and the stator part 23.

[0033] FIG. 4 is a schematic diagram of a contracted state of an embodiment of the present invention. As shown in FIG. 4 and FIG. 5, when the slide table 132 is closest to the proximal end of the catheter 1, the intraluminal fixation module 13 is in a contracted state, and each part of the intraluminal fixation module 13 is in a state of being in close contact with the outer wall of the catheter 1, ensuring the passability of the catheter 1. The elastic stent 131 of the intraluminal fixation module 13 is a superelastic metal material, which can be further contracted when pressed from the outside to further improve the passability. As the slide table 132 slides toward the distal end of the catheter 1, the intraluminal fixation module 13 unfolds, and the support stent 133 is in close contact with the lumen wall. The support stent 133 may be made of a radiopaque material, and may have a coil embedded therein to detect electromagnetic signals. The elastic stent 131 can ensure that the elastic force around the catheter 1 is kept constant, and the axis of the catheter is as consistent as possible with the axis of the lumen. In addition, the sliding distance d1 of the sliding table 132 is consistent with the moving distance of the externally driven sliding button 152, and when the stress of the elastic stent 131 is greater than a certain value, the elastic stent 131 drives the sliding table 132 to move backward until the stress of the elastic stent 131 reaches a reasonable range. In this way, through a specific position of the externally driven sliding button 152, a specific position of the supporting stent 133 can be obtained, and further, an approximate diameter of the inner wall of the current lumen can be obtained.

[0034] FIG. 6 is a schematic diagram of an embodiment of the ultrasound detection of the present invention. FIG. 6 shows a specific implementation of the catheter external ultrasound array 12 in a lumen. As shown in FIG. 6, the distal end of the catheter 1 includes a catheter external ultrasound array module 12, and the ultrasound transducer group 122 is uniformly distributed on the outer wall of the lumen along the circumferential direction. Each ultrasound transducer can transmit and receive signals independently. The ultrasound transducer group 122 transmits an ultrasound signal group 123a and another ultrasound signal group 123b at the same time to detect two points 124a and 124b in space, and the two sets of ultrasound arrays scan their respective areas, and then rotate clockwise or counterclockwise by the position of one ultrasound transducer to scan a new area, thereby creating an ultrasound image of the cross section of the area.

[0035] 7a, 7b, and 7c are respectively ultrasound display images of one embodiment of the present invention. In this embodiment, the image in FIG. 7a can be obtained by detecting the lumen 128 and the branch 129 by the ultrasound catheter. In particular, when used, the catheter 1, in a contracted state, enters the target lumen through a pre-established sheath passage, detects the intraluminal fixation device 13 at the distal end of the catheter 1 using an external image, determines that the position is approximately in the region of interest, and drives the slide button 152 to open the intraluminal fixation device 13 and make it adhere to the inner wall of the lumen. The ultrasound transducer group 122 of the catheter 1 is used to find the target branch of interest in the lumen, and when the ultrasound transducer group 122 succeeds in finding the possible branch of interest, starts to drive the rotor part of the rotating part 2 in the catheter.

[0036] FIG. 8 is a schematic diagram of a rotating part according to an embodiment of the present invention. As shown in FIG. 8, the proximal end of the rotating part 2 includes an assembled rotor part 22 and a stator part 23. The stator part 23 and the fixed connector 18 of the catheter 1 are locked and connected to each other and cannot rotate with each other. The rotor part 22 and the torque transmission tube 24 of the rotating part 2 are connected and cannot rotate with each other. The torque transmission tube 24 may be a braided tube or a hollow flexible shaft, and is for reliably transmitting the rotation of the rotor part 22 at the proximal end to the distal end hole 21 to rotate the distal end hole 21. The rotor part 22 and the stator part 23 rotate on the same axis and can indicate an angle between them. In the present invention, as an embodiment, the origin of the stator part 23 is aligned with a predetermined group of the ultrasonic transducer group 122 at the distal end of the catheter 1, and at the same time, the origin of the rotor part 22 is aligned with the distal end hole 21 of the rotating part 2. If the image shows that the angle (included angle) between the position corresponding to the branch notch (branch gap) and the origin of the ultrasonic transducer group 122 is α degrees, the rotor section at the distal end can be controlled by rotating the rotor section 22 to align the origin of the rotor section 22 with the α degree position.

[0037] 9 is a schematic diagram of a rotary encoder according to another embodiment of the present invention. As shown in FIG. 9, in this embodiment, the distal end hole 21 can be more reliably operated by directly reading the position of the distal end of the rotating part, and after the distal end of the rotating part 2 and the distal end of the catheter 1 are aligned, the relative position between the rotating part 2 and the catheter 1 is read by the encoder 25. A specific ultrasonic transducer inside the catheter 1 is defined as the origin, and a signal transmission source, for example, an optical signal transmission source, is disposed on the corresponding inner wall of the catheter. When the encoder 25 receives the optical signal, the specific angle of the current rotating part 2 can be obtained. The rotor part 22 and the stator part 23 may be the rotor and stator of a servo motor or a stepping motor, and rotate accurately under the control of an external signal. A specific representation in the image is shown in Figures 7(b) and 7(c), where the distal end hole 21 of the rotating part 2 is represented as a notch 125 in the image, and by rotating the rotating part 2, the notch 125 is aligned with the detected branch opening 126, i.e., the standard distal end hole 21 is aligned with the branch lumen opening 126 of interest.

[0038] Fig. 10 is a cross-sectional view of a rotating part according to an embodiment of the present invention. As shown in Fig. 10, by manipulating the rotating part 2, the distal end hole 21 of the rotating part 2 can be accurately aligned with the bifurcation of interest. The distal end hole 21 of the rotating part 2 is connected to the proximal end connection port of the rotating part 2, allowing the surgeon to insert a microcatheter or a guidewire. The internal structure of the distal end hole of the rotating part 2 has a guide surface 26 for guiding the guidewire or the microcatheter to exit from the distal end hole.

[0039] Fig. 11 is a schematic diagram of a sensor-equipped rotating part according to another embodiment of the present invention. Fig. 11 shows a sensor-equipped rotating part 2, and as shown in Fig. 11, a sensor array 32 is disposed on the rotating part, and the sensor array 32 is distributed on both sides of the distal end hole 21 along the axial direction and distributed in the radial direction to cover only the distal end hole 21. The sensor array 32 may be a set of ultrasonic arrays or infrared optical sensors to detect the contour of the inner wall around the sensor-equipped rotating part 2.

[0040] 12a and 12b are schematic diagrams showing the detection process of the inner wall of the lumen in one embodiment of the present invention. As shown in FIG. 12a and 12b, in such an embodiment, the stator 23 and the catheter fixing connector 18 are still firmly connected. The rotor 22 is driven by the motor to rotate, thereby rotating the entire rotating part 2, and the sensor 32 samples the surroundings at high speed. FIG. 12a and 12b show the detection process of the inner wall of the lumen, and each signal generator of the sensor array 32 can independently control the transmission, and the detection distance measuring point 34 is formed by the time difference of the transmission. The image is acquired in real time by the sensor array 32, and the sensor array 32 rotates, so that the requirements for the image acquisition efficiency are higher. According to the specific position of the slide button 152 of the catheter 1, the specific position of the support stent 133 can be obtained, and the approximate diameter of the inner wall of the current lumen can be obtained. By setting the diameter of the inscribed circle of the inscribed square of the predicted approximate diameter as the minimum value Ri of the range of interest, and the circumscribed circle of the circumscribed square of the predicted approximate diameter as the maximum value Ro of the range of interest, the number of scanning points can be significantly reduced, and the amount of calculation can be reduced. The area 33 surrounded by the dashed lines in Figures 12a and 12b above is the scanning area for each time.

[0041] Similarly, the position of the intraluminal fixation module 13 relative to the patient can predict when the catheter 1 and the rotating part 2 will reach the region of interest. The bifurcation of interest is found by detecting the rotating part 2. FIGS. 12a and 12b show the case where the bifurcation of interest is detected. When the sensor array 32 detects the bifurcation 326, the motor controls the rotor 22 to position it in a position opposite the bifurcation 326. Also, in this embodiment, the sensor array 32 is close to the distal end hole 21 of the rotating part 2, so that the distal end hole 21 of the rotating part 2 is reliably aligned with the bifurcation 326 at this time. Similarly, the surgeon can guide the guidewire or microcatheter to enter the target bifurcation of interest through the connection between the proximal end through hole and the distal end hole 21.

[0042] FIG. 13 is a schematic diagram of an embodiment of a balloon according to one embodiment of the present invention.

[0043] As shown in Fig. 13, another embodiment of the intraluminal fixation device 13 of the embodiment utilizes a compliance balloon 137, which is inflated and deflated to fix the catheter 1 within the lumen. Furthermore, the diameter of the lumen at the location of the catheter can be evaluated based on the amount of liquid injected and the change in pressure within the balloon 137. In a specific practical operation, the diameter of the lumen can be directly evaluated by inflating the balloon 137 with a radiopaque liquid.

[0044] FIG. 14 shows an actual operation demonstration 1 of one embodiment of the present invention.

[0045] As shown in FIG. 14, (a) in FIG. 14 shows a case where the catheter enters the lumen 51 in a contracted state. At this time, the detection of the ultrasound array 12 of the catheter forms a large angle with the axis of the lumen, and it is not possible to obtain a stable image because it sways within the lumen. By deploying the intraluminal fixation device 13, the axis of the catheter and the axis of the lumen basically coincide with each other, as shown in (b) in FIG. 14, and the ultrasound array 12 can detect the bifurcation 52 of interest and is stabilized in its vicinity. By operating the rotating unit 2, the distal end hole 21 is aligned with the bifurcation 52 of interest, and then the guidewire 53 is inserted into the target bifurcation 52 of interest from the distal end hole.

[0046] FIG. 15 shows a second practical operation demonstration of an embodiment of the present invention.

[0047] As shown in Fig. 15, (a) in Fig. 15 shows the case where the catheter enters the lumen 51 in a contracted state, and at this time, the detection of the sensor array 32 of the rotating part forms a large angle with the axis of the lumen, and a stable image cannot be obtained. By deploying the intraluminal fixing device 13, the sensor array 32 of the rotating part can scan and display the inner wall of the target lumen, as shown in (b) in Fig. 15. When it is confirmed that the observed branch lumen is the target branch lumen 52, the sensor array 32 is locked and focused on the branch lumen 52 by operating the motor, and then the guide wire 53 comes out of its distal end hole 21 and directly enters the target branch 52.

[0048] Although the embodiment of the present invention has been described above, it is not limited to the one set forth in the specification and the embodiment. It can be fully applied to various fields suitable for the present invention. Other modifications can be easily realized by those skilled in the art. Therefore, without departing from the general concept defined by the claims and the scope of equivalents thereof, the present invention is not limited to the specific details and examples shown and described herein.

Claims

1. 1. A medical catheter comprising a proximal end and a distal end, The distal end is a sensor array for displaying the condition of the inner wall of the lumen; a coaxial rotation device that is rotatable independently of other portions of the catheter and includes a through hole communicating with the exterior of the catheter for establishing a passage between the target branch lumen and the interior of the catheter; a fixing device for fixing the relative position between the distal end of the catheter and the inner wall of the lumen to ensure stability in the process of establishing a passage between the target branch lumen and the inside of the catheter; A medical catheter, characterized in that the sensor array can be aligned with the branched pipeline by guiding a distal end hole of a rotating portion having a through hole.

2. The medical catheter according to claim 1, characterized in that each individual sensor unit in the sensor array can transmit and receive signals independently, i.e., the signal attributes and transmission times can be controlled independently.

3. 2. The medical catheter of claim 1, wherein the sensor array is capable of guiding to align a through hole of a coaxial rotating device having a through hole with the branched pipeline by fully displaying an inner wall contour.

4. 2. The medical catheter of claim 1, wherein the sensor array is capable of guiding to align a distal end hole of a rotating portion having a through hole with the branched duct by partially displaying an inner wall contour.

5. 10. The medical catheter of claim 1, wherein the sensor array is uniformly distributable annularly at the distal end of the catheter for detection.

6. 10. The medical catheter of claim 1, wherein the sensor array is distributable for detection in any sectoral area of ​​the rotating catheter.

7. 2. The medical catheter according to claim 1, wherein the sensor array is an ultrasonic transducer array that transmits and receives ultrasonic signals to detect the contour of the inner wall of a lumen.

8. 8. The medical catheter according to claim 7, wherein the ultrasonic transducer arrays adjacent to the ultrasonic transducer array need to transmit and receive signals sequentially, and the arrays on both sides can transmit and receive signals simultaneously to improve imaging efficiency.

9. 8. The medical catheter according to claim 7, wherein the ultrasonic transducer array satisfies the need if it can distinguish a branch having a diameter of 0.3 mm.

10. 2. The medical catheter of claim 1, wherein the sensor array is an electromagnetic or photoelectric sensor that directly feeds back position information of the distal end of the rotatable device relative to the catheter body.

11. 2. The medical catheter of claim 1, wherein the sensor array is an optical sensor.

12. The medical catheter of claim 1 , wherein the fixation device is a balloon.

13. 2. The medical catheter of claim 1, wherein the fixation device is an elastic stent.

14. 2. The medical catheter according to claim 1, wherein the fixing device is a nitinol stent or a multi-link mechanism made of a hard material (titanium alloy or stainless steel) having excellent biocompatibility.

15. 2. The medical catheter of claim 1, wherein the fixation device has an actuation end at a proximal end of the catheter, and the fixation device can be actuated in a manual or automatic manner to switch or deform states to achieve stability of the relative position between the distal end of the catheter and the lumen.

16. 2. The medical catheter according to claim 1, wherein the coaxial rotation device is rotated manually.

17. 2. The medical catheter according to claim 1, wherein the rotation of the coaxial rotating device can be driven by a computer-controlled motor.

18. 2. The medical catheter according to claim 1, wherein the coaxial rotation device is rotatable independently of other portions of the catheter, and the rotation angle is controllable.

19. The medical catheter according to claim 1, characterized in that in the coaxial rotating device, the proximal ends of the catheter and the coaxial rotatable device are connected by a reliable mechanical structure, the proximal end and the distal end of the coaxial rotatable device are connected by a flexible shaft that can rotate synchronously, and the directional rotation of the coaxial rotating device rotates the through hole of the coaxial rotating device to align the angle with the target branch lumen, thereby helping to establish a positional relationship between the through hole and the target branch lumen.

20. 2. The medical catheter according to claim 1, wherein the relative angular relationship between the coaxial rotation device and the catheter can be provided by a structure at the proximal end and / or a group of position sensors at the distal end.

21. 2. The medical catheter according to claim 1, wherein data regarding the relative angular relationship between the coaxial rotation device and the catheter can be transmitted in real time to an operator to instruct him / her.

22. 2. The medical catheter according to claim 1, wherein the coaxial rotation device is capable of guiding a microcatheter or a guidewire from an inlet at a proximal end through a through-hole at a distal end.

23. The medical catheter of claim 1 , wherein the distal end includes a distal end localization device.

24. 24. The medical catheter of claim 23, wherein the distal end localization device can be constructed of a radiopaque material.

25. 24. The medical catheter of claim 23, wherein the distal end localization device is capable of being sprayed with radiopaque material to achieve a desired effect.

26. 24. The medical catheter of claim 23, wherein the distal end localization device is a pair of orthogonally arranged coils.

27. 24. The medical catheter of claim 23, wherein the distal end localization device is a series of electrodes capable of transmitting electrical signals.

Images