Interventional three-dimensional ultrasonic imaging device

Abstract

The present invention discloses an interventional three-dimensional ultrasonic imaging device, comprising: an ultrasonic imaging host, a handle connected to the ultrasonic imaging host, a catheter connected to the handle, and an array probe disposed in the catheter; the handle is used to provide a driving force for the rotation of the array probe and to realize signal transmission between the array probe and the ultrasonic imaging host; the array probe has a plurality of array elements arranged linearly, and the catheter is used to intervene in the body and realize three-dimensional ultrasonic imaging of the tissue to be measured through the rotation of the array probe. The present invention can achieve sector scanning through the array probe, and cooperate with the rotation of the array probe to achieve three-dimensional ultrasonic imaging, which can be used for the detection of bone or internal lesions; compared with the current ultrasonic systems on the market that can only obtain two-dimensional cross-sectional views of the cavity, the present invention can obtain more accurate and comprehensive information on the lesion site, and can improve the diagnostic accuracy of doctors.

Description

Technical Field

[0001] The present invention relates to the field of ultrasonic technology, and particularly to an interventional three-dimensional ultrasonic imaging device. Background Art

[0002] Ultrasonic devices are divided into extracorporeal and intracorporeal interventional devices. The extracorporeal ultrasonic device consists of a main unit and an ultrasonic probe. The ultrasonic probe is relatively large and is used for extracorporeal imaging of the heart, abdomen, bladder, thyroid, etc. The intracorporeal ultrasonic device consists of an imaging main unit, a control handle, and an ultrasonic wave that intervenes in the body. The intracorporeal probe is generally a long catheter structure with a very small diameter and can be used for ultrasonic imaging of the cardiovascular system, bronchus, digestive tract, etc. However, this imaging method of the intracorporeal probe can only obtain a cross-sectional two-dimensional ultrasonic image of the measured tissue and cannot perform three-dimensional imaging on the tissue. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to provide an interventional three-dimensional ultrasonic imaging device in view of the deficiencies in the above-mentioned prior art.

[0004] To solve the above technical problem, the technical solution adopted by the present invention is: an interventional three-dimensional ultrasonic imaging device, comprising: an ultrasonic imaging main unit, a handle connected to the ultrasonic imaging main unit, a catheter connected to the handle, and an array probe disposed in the catheter;

[0005] The handle is used to provide a driving force for the rotation of the array probe and to realize signal transmission between the array probe and the ultrasonic imaging main unit;

[0006] The array probe has a plurality of array elements arranged linearly. The catheter is used to intervene in the body and realizes three-dimensional ultrasonic imaging of the measured tissue through the rotation of the array probe.

[0007] Preferably, the handle includes a housing, a motor disposed in the housing, a transmission shaft drivingly connected to the motor, and a first connector drivingly connected to the end of the transmission shaft;

[0008] The catheter includes a catheter body having a hollow structure, a rotating shaft rotatably disposed in the catheter body, and a second connector drivingly connected to the proximal end of the rotating shaft. The array probe is disposed at the distal end of the rotating shaft;

[0009] Cables are disposed in the hollow cavities inside the transmission shaft and the rotating shaft; the first connector and the second connector are cooperatively connected to realize driving connection between the transmission shaft and the rotating shaft and electrical connection between the cables inside the transmission shaft and the rotating shaft.

[0010] Preferably, the array probe includes a backing layer, a flexible circuit board, a piezoelectric layer, a first matching layer, a second matching layer, and an acoustic lens layer that are sequentially stacked.

[0011] Preferably, the flexible circuit board includes a strip-shaped element pasting area arranged along the Y-axis direction and a plurality of strip-shaped flexible board units that can be rotated and folded around the Y-axis;

[0012] Element signal lead-out terminals and element ground lead-out terminals are respectively arranged at both ends of the element pasting area in the Y-axis direction. A gold plating layer is arranged on the element pasting area. The gold plating layer includes a plurality of gold plating strips that are linearly and spaced at intervals along the Y-axis direction and have the same number as the elements;

[0013] The element pasting area is on the front side of the flexible circuit board. A pad area is arranged on the front or back side of the end of the strip-shaped flexible board unit. After a plurality of strip-shaped flexible board units are folded around the Y-axis, the pad areas on all the strip-shaped flexible board units are aligned with the element pasting area along the Y-axis direction and arranged in sequence from top to bottom. The pad areas on each strip-shaped flexible board unit are on the front side of the flexible circuit board and are all exposed.

[0014] Preferably, an element signal pad and an element ground pad are sequentially arranged on the pad area along the Y-axis direction. The total number of element signal pads on all the pad areas is the same as the number of elements.

[0015] Preferably, the manufacturing process of the array probe includes the following steps:

[0016] 1) Grind and cut the shapes of the backing layer, piezoelectric layer, first matching layer, and second matching layer in advance, then paste the backing layer on the back side of the element pasting area, and paste the piezoelectric layer, first matching layer, and second matching layer on the gold plating layer on the front side of the element pasting area in sequence;

[0017] 2) Cut the elements. Separate each element through a cutting machine according to the spacing between each gold plating strip. The spacing between the elements is the spacing between the gold plating strips; Connect the signal terminals led out from each element to the element signal pads one by one through the element signal lead-out terminals, and connect the ground terminals led out from each element to the element ground pads through the element ground lead-out terminals; Then lead out a ground wire from the element ground pads, and pour and form the acoustic lens layer on the second matching layer, so as to form a plurality of the elements arranged linearly and spaced at intervals along the Y-axis on the element pasting area;

[0018] 3) Fold a plurality of the strip-shaped flexible board units around the Y-axis. After folding, the pad areas on all the strip-shaped flexible board units are aligned with the element pasting area along the Y-axis direction and arranged in sequence from top to bottom. The pad areas on each strip-shaped flexible board unit are on the front side of the flexible circuit board and are all exposed; The cross-sectional size of the folded flexible circuit board is reduced to a size that can be installed in the catheter body;

[0019] 4) Use encapsulation glue to stick the folded strip-shaped flexible plate unit;

[0020] 5) Connect the array element signal pads and the cables inside the rotating shaft in one-to-one correspondence.

[0021] Preferably, in step 5), the array element signal pads and the cables inside the rotating shaft are connected in one-to-one correspondence by welding coaxial cables.

[0022] Or the array element signal pads and the cables inside the rotating shaft are connected in one-to-one correspondence by using the method of pasting slender flexible plates.

[0023] Preferably, the first connector includes a first connecting sleeve connected to the transmission shaft, an electrical connection socket arranged inside the first connecting sleeve, and a connection key arranged on the first connecting sleeve;

[0024] The second connector includes a second connecting sleeve connected to the rotating shaft, an electrical connection plug arranged inside the second connecting sleeve for mating and plugging with the electrical connection socket, and a key slot opened on the second connecting sleeve for the connection key to be inserted into.

[0025] Preferably, an arc-shaped elastic piece is arranged on the inner wall of the key slot, and an arc-shaped clamping groove for cooperating with the arc-shaped elastic piece is opened on the outer wall of the connection key;

[0026] The insertion end of the connection key has an arc-shaped end face.

[0027] Preferably, the rotating shaft is connected to the second connecting sleeve through a connecting shaft section, and a first bearing is arranged between the connecting shaft section and the catheter body; two second bearings are arranged at intervals between the rotating shaft and the catheter body;

[0028] An installation groove communicating with the hollow cavity inside the rotating shaft is opened on the distal side wall of the rotating shaft, and the array probe is arranged in the installation groove.

[0029] The beneficial effects of the present invention are as follows:

[0030] The interventional three-dimensional ultrasonic imaging device of the present invention can achieve fan-shaped scanning through the array probe, and cooperate with the rotation of the array probe to achieve three-dimensional ultrasonic imaging, and can be used for the detection of bone or internal lesions; compared with the current ultrasonic systems on the market that can only obtain two-dimensional cross-sectional views of the cavity, the present invention can obtain more accurate and comprehensive information of the lesion site, improve the diagnostic accuracy of doctors; the three-dimensional image is also more intuitive, and the diagnostic difficulty for doctors is relatively reduced, and the lesion site can be directly seen, measured and inspected, and the diagnostic result can be obtained more quickly;

[0031] The structural design of the array probe of the present invention solves the difficulties encountered in the production and assembly of the probe, meeting the performance and external dimension requirements for clinical use. Description of the Drawings

[0032] Figure 1 It is a schematic diagram of the principle structure of the interventional three-dimensional ultrasonic imaging device of the present invention;

[0033] Figure 2 It is a schematic diagram of the structure of the first connector in Embodiment 2 of the present invention;

[0034] Figure 3 It is a schematic diagram of the structure of the catheter in Embodiment 2 of the present invention;

[0035] Figure 4 It is a schematic diagram of the structure of the second connector in Embodiment 2 of the present invention;

[0036] Figure 5 It is a schematic diagram of the structure after the connection of the first connector and the second connector in Embodiment 2 of the present invention;

[0037] Figure 6 For the present invention Figure 5 Partial enlarged structural schematic diagram of the connection part;

[0038] Figure 7 It is a schematic diagram of the sectional structure of the electrical connection socket in Embodiment 2 of the present invention;

[0039] Figure 8 It is a schematic diagram of the sectional structure of the electrical connection plug in Embodiment 2 of the present invention;

[0040] Figure 9 It is a schematic diagram of the structure of the mounting groove on the rotating shaft in Embodiment 2 of the present invention;

[0041] Figure 10 It is a schematic diagram of the stacked structure of the array probe in Embodiment 3 of the present invention;

[0042] Figure 11 It is a schematic diagram of the structure of the flexible circuit board in Embodiment 3 of the present invention;

[0043] Figure 12 It is a schematic diagram of the manufacturing process of the flexible circuit board in Embodiment 3 of the present invention;

[0044] Figure 13 It is a schematic diagram of a wiring method in Embodiment 3 of the present invention;

[0045] Figure 14 It is a schematic diagram of another wiring method in Embodiment 3 of the present invention.

[0046] Description of the Reference Numerals:

[0047] 1 - Ultrasonic imaging host

[0048] 2 - Handle; 20 - Housing; 21 - Motor; 22 - Transmission shaft; 23 - First connector; 24 - Signal coupling device; 25 - Protective sleeve; 230 - First connecting sleeve; 231 - Electrical connection socket; 232 - Connecting key; 233 - Arc-shaped card slot; 234 - Arc-shaped end face

[0049] 3 - Catheter; 30 - Catheter body; 31 - Rotating shaft; 32 - Second connector; 33 - Connecting shaft section; 34 - First bearing; 35 - Second bearing; 320 - Second connecting sleeve; 321 - Electrical connection plug; 322 - Keyway; 323 - Arc-shaped elastic piece; 310 - Mounting groove

[0050] 4 - Array probe; 40 - Backing layer; 41 - Flexible circuit board; 42 - Piezoelectric layer; 43 - First matching layer; 44 - Second matching layer; 45 - Acoustic lens layer; 410 - Array element paste area; 411 - Strip-shaped flexible board unit; 412 - Array element signal lead-out end; 413 - Array element ground lead-out end; 414 - Gold plating layer; 415 - Pad area; 416 - Array element signal pad; 417 - Array element ground pad; 4110 - First strip-shaped flexible board unit; 4111 - Second strip-shaped flexible board unit; 4112 - Third strip-shaped flexible board unit; 4113 - Fourth strip-shaped flexible board unit

[0051] 5 - Cable; 6 - Coaxial cable; 7 - Elongated flexible board; 8 - Hollow cavity Detailed implementation mode

[0052] The following further elaborates on the present invention in conjunction with embodiments, so that those skilled in the art can implement it with reference to the text of the specification.

[0053] It should be understood that terms such as "having", "including", and "comprising" as used herein do not exclude the presence or addition of one or more other elements or their combinations.

[0054] As Figure 1 shown, an interventional three-dimensional ultrasonic imaging device in this embodiment includes: an ultrasonic imaging host 1, a handle 2 connected to the ultrasonic imaging host 1, a catheter 3 connected to the handle 2, and an array probe 4 disposed in the catheter 3;

[0055] The handle 2, as a handheld component, is used to provide the driving force for the rotation of the array probe 4 and to achieve signal transmission between the array probe 4 and the ultrasonic imaging host 1;

[0056] The array probe 4 has a plurality of array elements arranged in a straight line. The catheter 3 is used for intervention in the body, and three-dimensional ultrasonic imaging of the tissue to be measured is achieved through the rotation of the array probe 4. The array probe 4 can perform sector scanning, and cooperate with the rotation of the array probe 4 to achieve three-dimensional imaging, and can obtain more intuitive and accurate ultrasonic images of the tissue, thereby improving the doctor's diagnosis efficiency. The above is the general concept of the present invention. Further embodiments are provided on this basis for more detailed description.

[0057] Embodiment 1

[0058] On the above basis, further, the handle 2 includes a housing 20, a motor 21 arranged in the housing 20, a transmission shaft 22 drivingly connected to the motor 21, and a first connector 23 drivingly connected to the end of the transmission shaft 22. In one embodiment, a signal coupling device 24 (a conventional product can be selected) is further arranged in the housing 20. The signal coupling device 24 is used to couple the rotating signal to the fixed signal line, and then signal-connected to the ultrasonic imaging host 1. The motor 21 can be controlled through the handle 2 or the ultrasonic imaging host 1. The ultrasonic imaging host 1 can select a conventional medical ultrasonic system, which is used for information interaction control with doctors and signal processing (ultrasonic imaging), etc.

[0059] The catheter 3 includes a catheter body 30 with a hollow structure, a rotating shaft 31 rotatably arranged in the catheter body 30, and a second connector 32 drivingly connected to the proximal end of the rotating shaft 31. The array probe 4 is arranged at the distal end of the rotating shaft 31. The catheter body 30 can adopt a hard or soft hollow structure. The hard structure can be used for ultrasonic detection in bones, and its materials can be various materials such as medical metals or plastics. In this embodiment, a hard structure is adopted. During use, an ultrasonic coupling agent is filled between the catheter body 30 and the rotating shaft 31 inside it, which is used to provide acoustic coupling between the transducer and the catheter 3. It should be understood that a sealing structure can be arranged in the second connector 32 to prevent the internal ultrasonic coupling agent from leaking.

[0060] The first connector 23 and the second connector 32 need to achieve rotational connection and signal connection. In this embodiment, cables 5 are arranged in the hollow cavities 8 inside the transmission shaft 22 and the rotating shaft 31; the first connector 23 and the second connector 32 are cooperatively connected to achieve the driving connection between the transmission shaft 22 and the rotating shaft 31 and the electrical connection between the cables 5 inside the transmission shaft 22 and the rotating shaft 31. Through the driving connection, the handle 2 can drive the array probe 4 to rotate, and through the electrical connection, the array probe 4 and the handle 2 can achieve signal and electrical connection.

[0061] Among them, the cable 5 inside the rotating shaft 31 can also be replaced by a whole flexible circuit board 41.

[0062] Embodiment 2

[0063] Reference Figures 2 - 9 , on the basis of Embodiment 1, further, the first connector 23 includes a first connecting sleeve 230 connected to the transmission shaft 22, an electrical connection socket 231 disposed within the first connecting sleeve 230, and a connection key 232 disposed on the first connecting sleeve 230; the second connector 32 includes a second connecting sleeve 320 connected to the rotating shaft 31, an electrical connection plug 321 disposed within the second connecting sleeve 320 for mating and plugging with the electrical connection socket 231, and a key slot 322 formed on the second connecting sleeve 320 for the connection key 232 to be inserted therein. A protective sleeve 25 is disposed outside the transmission shaft 22, and the transmission shaft 22 can rotate within the protective sleeve 25, and a bearing is provided therebetween.

[0064] The first connecting sleeve 230 is fixedly connected to the transmission shaft 22, the connection key 232 is fixedly connected to the first connecting sleeve 230, and the second connecting sleeve 320 is fixedly connected to the rotating shaft 31. The connection key 232 is inserted into the key slot 322 to achieve the driving connection between the first connector 23 and the second connector 32. Wires 5 are disposed inside both the transmission shaft 22 and the rotating shaft 31. The upper end of the electrical connection socket 231 is electrically connected to the wire 5 inside the transmission shaft 22, and the electrical connection plug 321 is electrically connected to the wire 5 inside the rotating shaft 31. After the electrical connection plug 321 is inserted into the electrical connection socket 231, the electrical connection between the wires 5 inside the transmission shaft 22 and the rotating shaft 31 is achieved, thereby realizing the signal and electrical transmission of the array probe 4.

[0065] After the first connector 23 is connected to the second connector 32, the electrical connection plug 321 is inserted into the electrical connection socket 231, and the connection key 232 is inserted into the key slot 322. The motor 21 drives the transmission shaft 22 to rotate, and the transmission shaft 22 drives the first connecting sleeve 230 and the electrical connection socket 231 to rotate together, thereby driving the electrical connection plug 321 and the second connecting sleeve 320 to rotate, and finally driving the rotating shaft 31 and the array probe 4 at the distal end of the rotating shaft 31 to rotate.

[0066] Furthermore, arc-shaped elastic pieces 323 are provided on the inner wall of the keyway 322, and arc-shaped clamping grooves 233 that cooperate with the arc-shaped elastic pieces 323 are formed on the outer wall of the connecting key 232. In this embodiment, arc-shaped elastic pieces 323 are symmetrically arranged on both sides of the inner wall of the keyway 322, and arc-shaped clamping grooves 233 are arranged on both sides of the outer wall of the connecting key 232. After the connecting key 232 is inserted into the keyway 322, the arc-shaped elastic pieces 323 are first squeezed. When the insertion is in place, the arc-shaped elastic pieces 323 recover and snap into the arc-shaped clamping grooves 233, and the arc-shaped elastic pieces 323 have an extrusion effect on the inner wall of the arc-shaped clamping grooves 233, so as to increase the stability and firmness of the connection between the connecting key 232 and the keyway 322. The insertion end of the connecting key 232 has an arc-shaped end face 234, and the arc-shaped end face 234 is provided to facilitate the smooth positioning and insertion of the connecting key 232 into the keyway 322. In this embodiment, the connecting key 232 includes two symmetrically arranged on the second connecting sleeve 320, and the keyway 322 includes two for cooperating with the two connecting keys 232 to improve the stability and strength of the connection of the keyway 322.

[0067] Furthermore, the rotating shaft 31 is connected to the second connecting sleeve 320 through a connecting shaft section 33, and a first bearing 34 is provided between the connecting shaft section 33 and the catheter body 30; two second bearings 35 are arranged at intervals between the rotating shaft 31 and the catheter body 30.

[0068] Furthermore, an installation groove 310 communicating with the hollow cavity 8 inside the rotating shaft 31 is formed on the distal side wall of the rotating shaft 31, and the array probe 4 is arranged in the installation groove 310; so that the cable 5 inside the rotating shaft 31 can be connected to the array probe 4 in the installation groove 310.

[0069] Embodiment 3

[0070] Refer to Figures 10 - 14, on the basis of Embodiment 1 or 2, the array probe 4 is further designed. The array probe 4 includes a backing layer 40, a flexible circuit board 41, a piezoelectric layer 42, a first matching layer 43, a second matching layer 44, and an acoustic lens layer 45 that are sequentially stacked. The backing layer 40 is used to absorb the backward signals emitted by the piezoelectric layer 42, and conventional backing layer 40 materials can be used (such as by uniformly mixing epoxy glue with tungsten powder or tungsten oxide powder and then curing); the flexible circuit board 41 is used to lead out the signals of each element; the piezoelectric layer 42 is used to convert electrical signals and ultrasonic signals into each other, and this part can be various piezoelectric materials such as piezoelectric ceramics, piezoelectric single crystals, and piezoelectric composite materials c-Mut; because there is a large impedance difference between the piezoelectric layer 42 and the tissue to be measured, the first matching layer 43 and the second matching layer 44 are used to improve the penetration efficiency of ultrasonic signals and increase the probe bandwidth, and the first matching layer 43 and the second matching layer 44 can be made of conventional matching layer materials (such as epoxy mixed with alumina powder, plastic, graphite, ceramics, etc.); the acoustic lens layer 45 mainly provides protection for the radiation surface of the probe and has a focusing effect, which can improve the image quality. The design of the array probe 4 needs to be theoretically calculated according to the performance requirements of the transducer to be manufactured.

[0071] Further preferably, the flexible circuit board 41 includes a strip-shaped element pasting area 410 arranged along the Y-axis direction and a plurality of strip-shaped flexible board units 411 that can be rotated and folded around the Y-axis;

[0072] Element signal lead-out terminals 412 and element ground lead-out terminals 413 are respectively arranged at both ends of the element pasting area 410 in the Y-axis direction. A gold plating layer 414 is arranged on the element pasting area 410. The gold plating layer 414 includes a plurality of gold plating strips that are linearly spaced along the Y-axis direction and have the same number as the number of elements; the gold plating strips are slender strip-shaped, and the gold plating strips are used to contact the signal poles of the piezoelectric material. An element is formed on each gold plating strip, and the distance between the gold plating strips is the distance between the elements. Such a design is that when cutting to form elements, the elements are cut according to the distance between the gold plating strips, which can avoid cutting into the metal layer during cutting, resulting in an increase in cutting load and a decrease in the process qualification rate.

[0073] The element pasting area 410 is on the front side of the flexible circuit board 41. A pad area 415 is arranged on the front or back side of the end of the strip-shaped flexible board unit 411. After a plurality of strip-shaped flexible board units 411 are folded around the Y-axis, the pad areas 415 on all strip-shaped flexible board units 411 are aligned with the element pasting area 410 along the Y-axis direction and are arranged in sequence from top to bottom. The pad area 415 on each strip-shaped flexible board unit 411 is on the front side of the flexible circuit board 41 and is exposed.

[0074] Element signal pads 416 and element ground pads 417 are sequentially arranged on the pad area 415 along the Y-axis direction. The total number of element signal pads 416 on all pad areas 415 is the same as the number of elements.

[0075] Further preferably, in this embodiment, the number of strip-shaped flexible plate units 411 is 4, and they are arranged in pairs on both sides of the element pasting area 410. Refer to Figure 11 , from left to right, they are the first, second, third, and fourth strip-shaped flexible plate units 4110, 4111, 4112, and 4113 in sequence; the lengths of the four strip-shaped flexible plate units 411 are different, so that the heights of the pad areas 415 at their ends are different, so as to ensure that the four pad areas 415 arranged in a straight line along the Y-axis after folding do not overlap and can all be exposed. In this embodiment, the length relationship of the four strip-shaped flexible plate units 411 is: the second strip-shaped flexible plate unit 4111 < the first strip-shaped flexible plate unit 4110 < the third strip-shaped flexible plate unit 4112 < the fourth strip-shaped flexible plate unit 4113. And the pad areas 415 on the first and fourth strip-shaped flexible plate units are on the front side, and the pad areas 415 on the second and third strip-shaped flexible plate units are on the back side. Refer to Figure 12 , when folding, first rotate the first and second strip-shaped flexible plate units as a whole 180° towards the element pasting area 410 for folding, and the second strip-shaped flexible plate unit 4111 is folded to the back side of the element pasting area 410; then rotate the first strip-shaped flexible plate unit 4110 180° away from the element pasting area 410 for folding, and the first strip-shaped flexible plate unit 4110 is folded to the back side of the second strip-shaped flexible plate unit 4111; then rotate the third and fourth strip-shaped flexible plate units as a whole 180° towards the element pasting area 410 for folding, and the third strip-shaped flexible plate unit 4112 is folded to the back side of the first strip-shaped flexible plate unit 4110; then rotate the fourth strip-shaped flexible plate unit 4113 180° away from the element pasting area 410 for folding, and the fourth strip-shaped flexible plate unit 4113 is folded to the back side of the third strip-shaped flexible plate unit 4112; so that the first, second, third, and fourth strip-shaped flexible plate units are all folded to the back side of the element pasting area 410, and the pad areas 415 on the second, third, and fourth strip-shaped flexible plate units are all on the front side, and are arranged in a straight line along the Y-axis from top to bottom and are all exposed.

[0076] The manufacturing process of the array probe 4 in the above embodiment includes the following steps:

[0077] 1) Grind and cut the back lining layer 40, piezoelectric layer 42, first matching layer 43, and second matching layer 44 in advance, and then paste the back lining layer 40 on the back side of the element pasting area 410, and paste the piezoelectric layer 42, first matching layer 43, and second matching layer 44 on the gold plating layer 414 on the front side of the element pasting area 410 in sequence;

[0078] 2) Perform the cutting of the array elements. Separate each array element through a cutting machine according to the spacing between each gold-plated strip, and the spacing between the array elements is the same as the spacing between the gold-plated strips. Connect the signal terminals led out from each array element to the array element signal pads 416 in a one-to-one correspondence through the array element signal lead-out terminals 412, and connect the ground terminals led out from each array element to the array element ground pads 417 through the array element ground lead-out terminals 413. Then lead out the ground wire from the array element ground pads 417, and cast to form an acoustic lens layer 45 on the second matching layer 44, so as to form a number of array elements arranged at straight-line intervals along the Y-axis on the array element bonding area 410.

[0079] 3) Fold the 4 strip-shaped flexible board units 411 according to the above method. After folding, the pad areas 415 on all the strip-shaped flexible board units 411 are aligned with the array element bonding area 410 along the Y-axis direction and arranged in sequence from top to bottom. The pad areas 415 on each strip-shaped flexible board unit 411 are all on the front side of the flexible circuit board 41 and are all exposed to facilitate the leading-out of the signal lines. The cross-sectional dimension of the folded flexible circuit board 41 is reduced to a size that can be installed in the catheter body 30.

[0080] 4) Use encapsulating glue to stick the folded strip-shaped flexible board units 411.

[0081] 5) Connect the array element signal pads 416 to the cables 5 in the rotating shaft 31 in a one-to-one correspondence to lead out the array element signals.

[0082] Among them, the signal lines can also be led out after the first step of pasting, but because the leads are relatively fragile, they may be more easily damaged during folding, so it is preferred to connect the leads in the last step.

[0083] In a preferred embodiment, in step 5), the array element signal pads 416 are connected to the cables 5 in the rotating shaft 31 in a one-to-one correspondence by welding the coaxial cables 6. Since the cables have good flexibility and can bear a certain torsional force, the cables inside can be appropriately twisted when the probe rotates. According to experiments, the torsional angle can reach nearly 90 degrees and can scan a range of nearly 180 degrees, which can meet the clinical needs. In this way, the signal coupling device 24 can be omitted inside the handle 2, making the overall product structure simpler and the cost reduced.

[0084] In another preferred embodiment, in step 5), the array element signal pads 416 are connected to the cables 5 in the rotating shaft 31 in a one-to-one correspondence by using the method of pasting the slender flexible board 7. Although the slender flexible board can accept a smaller rotation angle, experiments show that it can rotate at most 30 degrees. Excessive rotation may cause tearing of the flexible board, and a signal coupling device 24 needs to be provided inside the handle 2. This process is also relatively mature and is a feasible solution.

[0085] Although the embodiments of the present invention have been disclosed as above, they are not limited to the applications listed in the specification and embodiments. It can be fully applied to various fields suitable for the present invention. For those skilled in the art, additional modifications can be easily made. Therefore, without departing from the general concept defined by the claims and the equivalent scope, the present invention is not limited to specific details.

Claims

1. An interventional three-dimensional ultrasonic imaging device, characterized in that, it includes: an ultrasonic imaging host, a handle connected to the ultrasonic imaging host, a catheter connected to the handle, and an array probe disposed in the catheter; the handle is used to provide a driving force for the rotation of the array probe and to achieve signal transmission between the array probe and the ultrasonic imaging host; the array probe has a plurality of elements arranged linearly, and the catheter is used to intervene in the body and achieve three-dimensional ultrasonic imaging of the tissue to be measured through the rotation of the array probe; the array probe includes a backing layer, a flexible circuit board, a piezoelectric layer, a first matching layer, a second matching layer, and an acoustic lens layer that are sequentially stacked; the flexible circuit board includes a strip-shaped element bonding area disposed along the Y-axis direction and a plurality of strip-shaped flexible board units that can be rotated and folded around the Y-axis; element signal lead-out ends and element ground lead-out ends are respectively disposed at both ends of the element bonding area in the Y-axis direction, a gold plating layer is disposed on the element bonding area, and the gold plating layer includes a plurality of gold plating strips that are linearly spaced along the Y-axis direction and have the same number as the elements; the element bonding area is on the front surface of the flexible circuit board, a pad area is disposed on the front or back surface of the end of the strip-shaped flexible board unit, and after a plurality of strip-shaped flexible board units are folded around the Y-axis, the pad areas on all the strip-shaped flexible board units are aligned with the element bonding area along the Y-axis direction and arranged in order from top to bottom, and the pad areas on each strip-shaped flexible board unit are on the front surface of the flexible circuit board and are all exposed.

2. The interventional three-dimensional ultrasonic imaging device according to claim 1, characterized in that, the handle includes a housing, a motor disposed in the housing, a transmission shaft drivingly connected to the motor, and a first connector drivingly connected to the end of the transmission shaft; the catheter includes a catheter body having a hollow structure, a rotating shaft rotatably disposed in the catheter body, and a second connector drivingly connected to the proximal end of the rotating shaft, and the array probe is disposed at the distal end of the rotating shaft; cables are disposed in the hollow cavities inside the transmission shaft and the rotating shaft; the first connector and the second connector are cooperatively connected to achieve driving connection between the transmission shaft and the rotating shaft and electrical connection between the cables inside the transmission shaft and the rotating shaft.

3. The interventional three-dimensional ultrasonic imaging device according to claim 1, characterized in that, element signal pads and element ground pads are sequentially disposed on the pad area along the Y-axis direction, and the total number of element signal pads on all the pad areas is the same as the number of elements.

4. The interventional three-dimensional ultrasonic imaging device according to claim 3, characterized in that, the manufacturing process of the array probe includes the following steps: 1) Pre-grind and cut the shapes of the backing layer, piezoelectric layer, first matching layer, and second matching layer in advance, then paste the backing layer on the back surface of the element bonding area, and paste the piezoelectric layer, first matching layer, and second matching layer on the gold plating layer on the front surface of the element bonding area in sequence; 2) Perform the cutting of the array elements. Separate each array element through a cutting machine according to the spacing between each gold-plated strip, and the spacing between the array elements is the same as the spacing between the gold-plated strips; Connect the signal terminals led out from each array element to the array element signal pads in one-to-one correspondence through the array element signal lead-out terminals, and connect the ground terminals led out from each array element to the array element ground pads through the array element ground lead-out terminals; Then lead out a ground wire on the array element ground pads, and cast to form the acoustic lens layer on the second matching layer, so as to form a plurality of the array elements arranged at intervals in a straight line along the Y-axis on the array element bonding area; 3) Fold a plurality of the strip-shaped flexible board units around the Y-axis. After folding, the pad areas on all the strip-shaped flexible board units are aligned with the array element bonding area in the Y-axis direction and arranged in order from top to bottom, and the pad areas on each strip-shaped flexible board unit are all on the front side of the flexible circuit board and are all exposed; The cross-sectional dimension of the folded flexible circuit board is reduced to a size that can be installed inside the catheter body; 4) Use encapsulation glue to stick the folded strip-shaped flexible board units; 5) Connect the array element signal pads to the cables inside the rotating shaft in one-to-one correspondence.

5. The invasive three-dimensional ultrasonic imaging device according to claim 4, characterized in that, in step 5), the array element signal pads are connected to the cables inside the rotating shaft in one-to-one correspondence by welding coaxial cables, or the array element signal pads are connected to the cables inside the rotating shaft in one-to-one correspondence by using the method of pasting slender flexible boards.

6. The invasive three-dimensional ultrasonic imaging device according to claim 2, characterized in that, the first connector includes a first connecting sleeve connected to the transmission shaft, an electrical connection socket arranged inside the first connecting sleeve, and a connection key arranged on the first connecting sleeve; the second connector includes a second connecting sleeve connected to the rotating shaft, an electrical connection plug arranged inside the second connecting sleeve for mating and plugging with the electrical connection socket, and a key slot opened on the second connecting sleeve for the connection key to be inserted into.

7. The invasive three-dimensional ultrasonic imaging device according to claim 6, characterized in that, an arc-shaped elastic piece is arranged on the inner wall of the key slot, and an arc-shaped card slot for mating with the arc-shaped elastic piece is opened on the outer wall of the connection key; the insertion end of the connection key has an arc-shaped end face.

8. The invasive three-dimensional ultrasonic imaging device according to claim 7, characterized in that, the rotating shaft is connected to the second connecting sleeve through a connecting shaft section, and a first bearing is arranged between the connecting shaft section and the catheter body; Two second bearings are arranged at intervals between the rotating shaft and the catheter body; an installation groove communicating with the hollow cavity inside the rotating shaft is opened on the side wall of the distal end of the rotating shaft, and the array probe is arranged in the installation groove.

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