APPARATUS OF COMBINING IMAGING ULTRASONIC PROBE AND FOCUSED ULTRASONIC PROBE
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to an apparatus for ultrasound image-guided focused ultrasound treatment, and more particularly to an apparatus which can adjust the focal position of a focused ultrasound probe in depth and combine an imaging ultrasonic probe with a focused ultrasound probe to monitor the therapeutic position and therapeutic effect of the focused ultrasound.
2. Background
In clinical practice, the imaging ultrasound probe is a non-invasive tool, from in vitro contact with the skin to generate pulse waves and receive echo signals from the body's tissues, organs to form their ultrasound images, in order to determine the tissue morphology, properties and location.
In clinical practice or research, the focused ultrasound (FUS) probe is mainly non-invasive way, from in vitro contact with the body for thermal ablation, the mild heating treatment or deep massage of cells and tissues, in order to burn pathological tissues of the body, reduce the excess cells of the body, enhance blood flow, or stimulate the cells.
In practice, FUS requires aided image feedback to observe and monitor the treatment procedure. Otherwise, the FUS will be performed in a general position, with less precise and accurate position judgment treatment and immediate effect observation, which may lead to a course of treatment that may require re-treatment or a possible loss of treatment efficacy.
Medical imaging technologies have been adopted to facilitate clinicians to identify the treated target tissue before FUS exposure, such as magnetic resonance imaging (MRI) and
ultrasound imaging. Without the use of MRI or ultrasound imaging, the tissue out of the target may be damaged by FUS-induced heat or pressure.
MRI-guided FUS systems specific for treatments of uterine fibroids, bone metastases and essential tremor have been approved by the US FDA. MRI anatomic images, temperature and thermo-dose images are used as a feedback to confirm if the FUS focal zone aims at the target tissue. Once MRI images show that FUS focal zone is not at the exact position during the FUS exposure, the FUS system is shut down immediately. For the brain or the target tissue deep from the skin, MRI monitoring is required for safety of FUS exposure. However, the ultrasound imaging technique is used to replace the MRI technique for FUS treatment of the shallow target tissue because MRI has weaknesses of high cost and bulky scanner.
Ultrasound imaging-guided FUS systems specific for treatment of prostate cancers have gained the US FDA clearance. Ultrasound imaging technology has the advantages of real-time imaging, good mobility, friendly operation, and relatively low cost, thus it has become a first-line diagnostic tool in hospitals. However, the current commercially available ultrasound imaging scanners or those already set in hospitals can not be directly combined with the FUS probes, resulting in the need for the users to purchase a new ultrasound imaging-guided FUS system. This will result in increased operating costs and increased demand for space. Moreover, the ultrasound imaging scanner in the ultrasound imaging-guided FUS system is not used for general diagnosis.
BRIEF SUMMARY OF THE INVENTION
A main object of the present invention is to provide an apparatus of combining an imaging ultrasonic probe and a FUS probe, namely, a package for accommodating a FUS probe incorporating an imaging ultrasonic probe, which can simultaneously perform the image ultrasound scanning and FUS therapy.
A further object of the present invention is to provide a convenient mechanism for placing an imaging ultrasonic probe quickly from the center of the main body of the FUS probe package and placing the imaging ultrasonic probe directly along the slide rail. The mechanism consists of the symmetrical pressure spring, the inner structure and the gel film of the inner structure, and the imaging ultrasonic probe and the FUS probe are firmly and tightly integrated into one body.
A further object of the present invention is to provide a convenient and quick way of separating the imaging ultrasonic probe which has been combined with the FUS probe. By pressing the key in the first embodiment or pushing the button in the second embodiment, the movable spring driven by the pressure spring can be pushed directly to the slide rail, and the imaging ultrasonic probe and the FUS probe for the separation of the action.
A further object of the present invention is to provide a convenient way of adjusting the focal zone of the FUS probe to the treatment target in depth. By rotating the rotary ring in the first embodiment, the long convex axis of the rotary ring is rotated along the horizontal rail of the coupling ring and the spiral track on the front end cap is driven so that the front end cover can be moved up and down to adjust the distance between the skin and the focal zone beneath the skin.
To achieve the main objective, the present invention provides an apparatus of combining an imaging ultrasonic probe and a FUS probe, the apparatus comprising: a main body having a first inner accommodation space and an opening located at a rear end face of the main body, the first inner accommodation space communicated with the opening and provided with a joint portion; a front end portion connected to a front end of the main body and having a front end cover and a second inner accommodation space surrounded by the front end cover, the second internal accommodation space filled with a recyclable conductive
substance; and a focused ultrasound probe comprising at least one piezoelectric sheet, connected between the main body and the front end portion.
In one embodiment of the present invention, the second internal accommodation space is filled with a conductive substance with a recyclable flow property and a through port which can be circulated flows into and out the conductive substance is provided on both sides of the upper end of the coupling ring.
In one embodiment of the present invention, the first inner accommodation space further provides a guide groove for sliding the imaging ultrasonic probe.
In one embodiment of the present invention, the joint portion symmetrically provide a movable fixing lever, a push rod, a pressure spring and a disengagement element, wherein one end of the movable fixing rod is fixed to the inside of the main body through a fixed shaft member, and a side line of the movable fixed lever is in contact with the pressure spring which is also fixed to the inside of the main body, the other end of the movable fixing rod corresponding to one end connected to the fixed shaft member is connected to one end of the push rod, and the other end of the push rod is connected to the disengagement element.
In one embodiment of the present invention, the piezoelectric sheet is an arc-shaped, spherical, parabolic, or other focusable single element sheet configuration.
In one embodiment of the present invention, the piezoelectric sheet is a circular, spherical, parabolic shape, or other focusing multi-piezoelectric element sheet configuration.
In one embodiment of the present invention, the piezoelectric sheet is a planar piezoelectric sheet formed by a multi -piezoelectric sheet.
In one embodiment of the present invention, the gel film is further provided between the focused ultrasound probe and the first internal accommodation space for isolating from the imaging ultrasonic probe and a conductive substance filled in the second internal accommodation space.
In one embodiment of the present invention, the front end portion further provides a coupling ring which is engaged with the front end cover and fixed to the main body.
In one embodiment of the present invention, the disengagement element is a key or a button.
In one embodiment of the present invention, the material of the film is selected from one of the groups of polyethylene, polypropylene, polysiloxane, polyurethane and macromolecule hydrocarbons, or any combination thereof.
BREIF DESCRIPTION OF THE DRAWINGS
All the objects, advantages, and novel features of the invention will become more apparent from the following detailed descriptions when taken in conjunction with the accompanying drawings.
Fig. 1 is a longitudinal cross-sectional view of a preferred embodiment of an apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention;
Figs. 2A to 2C are dynamic side views of the apparatus connected to the imaging ultrasonic probe of a preferred embodiment of an apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention;
Figs. 3A to 3D are schematic longitudinal cross-sectional view of the apparatus connected to the imaging ultrasonic probe of a preferred embodiment of an apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention;
Fig. 4 is a side view of the joint portion of another preferred embodiment of the apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention;
Figs. 5 A and 5B are plan views of the joint portion of another preferred embodiment of the apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention;
Figs. 6A to 6C are dynamic side views of the apparatus connected to the imaging ultrasonic probe of another preferred embodiment of the apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention;
Figs. 7A to 7C are schematic longitudinal cross-sectional views of the apparatus connected to the imaging ultrasonic probe of another preferred embodiment of the apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention;
Figs. 8 is a vertical section view of the adjustable depth distance of another preferred embodiment of the apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention;
Figs. 9 shows an exploded view of the front end portion of the adjustable depth distance of another preferred embodiment of the apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention; and
Figs. 10A to 10B is an up-down action view of the front end portion of the adjustable depth distance of another preferred embodiment of the apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention.
DETAILED DESCRIPTION OF THE INVENTION
Although the invention has been explained in relation to several preferred embodiments, the accompanying drawings and the following detailed descriptions are the preferred embodiment of the present invention. It is to be understood that the following disclosed descriptions will be examples of present invention, and will not limit the present invention into the drawings and the special embodiments.
In the previous inventions, although the ultrasound imaging-guided FUS system possesses both functions of ultrasound imaging and FUS treatment, the ultrasound imaging subsystem in the system can not be used for generally diagnostic applications. The apparatus of the present invention provides a packaging capable of accommodating a focused ultrasound probe incorporating an imaging ultrasonic probe which can be simultaneously scanned using imaging ultrasound probe and treated with the focused ultrasound probe. The apparatus of the present invention is provided with a piezoelectric sheet inside the focused ultrasonic probe and is in indirect contact with the conductive substance at the front end portion for conduction. The apparatus of the present invention is provided with an accommodation space and a guide groove in the inside thereof to fix the probe structure so as to facilitate the insertion and incorporation of the imaging ultrasonic means to each other to achieve the purpose of focused ultrasonic probe in combination with the imaging ultrasonic probe. The apparatus of the present invention adjusts the depth of the focal zone of the focused ultrasound probe to make the focal zone locate inside the target tissue under the guidance of ultrasound imaging.
The following description of the material, properties, and methods of preparation of a focused ultrasound probe which can accommodate an imaging ultrasonic probe, and an adjustable depth distance mechanism according to the present invention is further described. The embodiments are for illustrative purposes only and are not to be construed as limiting the scope of the invention, and other embodiments are subject to modification and modification without departing from the spirit and scope of the invention, and are within the scope of the invention.
Please refer to Fig. 1, Fig. 2A to 2C and Fig. 3 A to 3D , they are a longitudinal cross-sectional view, a dynamic view and a schematic longitudinal cross-sectional view of the apparatus connected to the imaging ultrasonic probe of an apparatus of combining an imaging
ultrasonic probe and a focused ultrasound probe in accordance with the present invention, respectively.
The apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe comprises a main body 10 having a first inner accommodation space 11 and an opening 12 located on the rear end face of the main body 10. The first inner accommodation space 11 communicates with the opening 12 and is provided with a joint portion 13 inside thereof. Through the foregoing design, an imaging ultrasonic probe 40 can enter the inside of the first inner accommodation space 11 provided by the present embodiment via the opening 12. In addition, by means of the design of the joint portion 13, the imaging ultrasonic probe 40 can be combined with the focused ultrasonic probe 30 and further inside the apparatus. On the other hand, the apparatus is provided with a front end portion 20 which is connected to the front end of the main body 10. The front end portion 20 includes a front end cover 21 and a second inner accommodation space 22 surrounded by the front end cover 21. The front end cover 21 is used for contact with the patient's skin. At the same time, the second inner accommodation space 22 is filled with a conductive substance, and the conductive substance is degassed water or an ultrasonic conduction medium. With this conductive substance, the ultrasound waves generated by an imaging ultrasonic probe 40 can be propagated to the target and return through the front end cover 21 and intermediate tissues to obtain ultrasound images of target and neighboring tissues. The interior of the apparatus is further provided with a focused ultrasound probe 30, comprising at least one piezoresistive sheet (not shown). The focused ultrasonic probe 30 is connected between the main body 10 and the front end portion 20 to receive a voltage and convert it into mechanical waves required for ultrasonic treatment.
In a preferred embodiment of the present invention, in order to allow the imaging ultrasonic probe 40 to enter into the first inner accommodation space 11 in a correct introduction direction for positioning engagement, the interior of the main body 10 is further
provided with a guide groove (not shown). Through the arrangement of the guide groove, the imaging ultrasonic probe 40 can be inserted into the main body 10 at a fixed angle in accordance with the direction of introduction of the guide groove. Further, the imaging ultrasonic probe 40 can be engaged with a specific bonding angle of the joint portion 13 to perform a close engagement so as to achieve the purpose of the imaging ultrasonic probe 40 used in conjunction with the focused ultrasonic probe 30.
In another preferred embodiment of the present invention, the joint portion 13 may further comprises a plurality of interlocking elements for fixing the imaging ultrasonic probe 40. In this embodiment, the joint portion 13 comprises a movable fixing lever 131, a fixed shaft member 132, a pressure spring 133, a push rod 134, and a disengagement element 135, which are arranged symmetrically. Wherein, one end of the movable fixing rod 131 is fixed to the inside of the main body 10 through the fixed shaft member 132 to provide a fulcrum for swinging the movable fixing lever 131. And the side of the movable fastening lever 131 is in contact with the pressure spring 133, which is also fixed to the inside of the main body 10. The resilience of the pressure spring 133 may provide the resetting power of the movable fixing lever 131 so that the movable fixing lever 131 can enter the first inner accommodation space 11 to make the imaging ultrasonic probe 40 reach the positioning and to provide a fixed engaging pressure to the imaging ultrasound probe 40 for positioning. On the other hand, the other end of the movable fixing lever 131 corresponds to one end connected to the fixed shaft member 132 and is connected to one end of the push rod 134. And the other end of the push rod 134 is connected to the disengagement element 135. When the push rod 134 is driven by the movement of the disengagement element 135, it drives the movable fixing lever 131 to move in the direction of the pressure spring 133 to release the restriction function of the movable fixing lever 131, thus the imaging ultrasonic probe 40 is able to enter or exit in a less resistant manner.
Wherein, the material of the focused ultrasonic probe 30 is made of a piezoelectric material, and the piezoelectric material may be composed of a single piece of piezoelectric material, or may be a combination of a plurality of piezoelectric sheets. On the other hand, the shape of the piezoelectric sheet is a focused geometry. Thus, the shape of the piezoelectric sheet may be circular or parabolic. According to the above-mentioned principle, in the preferred embodiment of the present invention, the piezoelectric sheet may be in the form of an arc-shaped, spherical, parabolic, or other focusing single-element sheet configuration. Alternatively, in another preferred embodiment of the present invention, the piezoelectric sheet may be in the form of an arcuate, spherical, parabolic, or other focusing multi -piezoelectric sheet configuration. In addition, in the further preferred embodiment of the present invention, the piezoelectric sheet is a planar piezoelectric sheet formed by a multi-piezoelectric sheet.
In another preferred embodiment of the present invention, an adhesive gel film 50 is further provided between the focused ultrasound probe 30 and the first internal accommodation space 12. In this embodiment, with this design, the adhesive gel film 50 can isolate the imaging ultrasonic probe 40 and the conductive substance of the second internal accommodation space 22 when the imaging ultrasonic probe 40 is placed in the first internal accommodation space 12. So that, the imaging ultrasonic probe 40 and the second internal accommodation space 22 will not be exposed to each other to affect the use of ultrasonic detection. Wherein, the adhesive gel film 50 is a material having an elastic function and is adapted to a surface which may be different in the front end of the imaging ultrasonic probe 40. The material of the adhesive gel film 50 is selected from one of the groups consisting of polyethylene, polypropylene, polysiloxane, polyurethane and high molecular weight hydrocarbons, or any combination thereof, based on the foregoing principles.
In another preferred embodiment of the present invention, the front end portion 20 is further provided with a coupling ring 23. When the front end cover 21 is joined to the main body 10, the coupling ring 23 is tightly fitted over the front end cover 21 and the main body 10 to provide a greater coupling force between the front end cover 21 and the front end portion 20 to avoid the fall off due to continuous contact with the user when used.
Please refer to Fig. 2A to 2C and Fig. 3A to 3D again, they are dynamic views and a schematic longitudinal cross-sectional views of the apparatus connected to the imaging ultrasonic probe of an apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention, respectively. As shown in Fig. 3 A, when the apparatus is combined with the imaging ultrasonic probe 40, the imaging ultrasonic probe 40 is inserted from the opening 12 and along the first inner accommodation space 11 communicating with the opening 12 of the guide groove slowly slide into. Then, as shown in Figs. 3B and 3C, the imaging ultrasonic probe 40 will touch the movable fixing lever 131 on both sides and push the movable fixing lever 131 toward both sides to continue to enter the inside of the first inner accommodation space 11. The push rod 134 applies a pulling force to the movable fixing lever 131 so that the movable fixing lever 131 is rotated rearwardly of the fixed shaft 132 to allow a space of the guide groove of the first inner accommodation space 11. Whereby, the imaging ultrasonic probe 40 can smoothly slide to the positioning point, and the detachment device 135 protrudes toward the outside of the main body 10. At this point, the imaging ultrasonic probe 40 will be tightly coupled with the package structure containing the focused ultrasound probe 30, as shown in Fig. 3D.
Please refer to Figure 4 and Figs. 5A and 5B, they are a side view and plan views of the joint portion of another preferred embodiment of the apparatus connected to the imaging ultrasonic probe of an apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe in accordance with the present invention, respectively. This further preferred
embodiment provides another form of the joint portion 13 for fixing the imaging ultrasonic probe 40. The joint portion 13 includes at least one button 60 and a cam member 61. The cam member 61 is a symmetrical structure which is divided into two sections by a central axis, each of which is a thick to thin blade structure, and the two thick and thick ends are opposed to the thin end and the thin end.
Wherein, the at least one button 60 is connected to the rear end side of the cam member 61 and protrudes outwardly beyond the main body 10. In this embodiment, when the at least one button 60 is energized to rotate the cam member 61, the cam member 61 will affect the space in which the push rod 134 extends due to a change in thickness. The space between the pressure spring 133 and the movable fixing lever 131 is changed to affect the space of the first inner accommodation space 11 so as to fix the imaging ultrasonic probe 40.
The other embodiments of the present invention are shown in Figs. 6A to 6C of the present invention, and a side view showing the combination of the main body 10 and the imaging ultrasonic probe 40 is shown. The preferred embodiment is the same as that of the foregoing preferred embodiment, in which the combination of the probes is inserted from the rear end interface. Please also refer to Fig. 7A to 7C, the imaging ultrasonic probe 40 is inserted from the opening 12 at the rear end of the main body 10 and along the guide groove in the main body 10. The imaging ultrasonic probe 40 is fixed to the movable fixing rod 131 inside the main body 10 and the movable fixing rod 131 is pushed toward both sides to continue to enter the inside of the first inner accommodation space 11. At this time, the at least one button 60 is driven to drive the cam member 61 and the push rod 134 so that the push rod 134 pulls the movable fixing lever 131 rearward. Whereby, the movable fixing rod 131 is rotated rearward about the fixed shaft 132 to allow a space of the guide groove of the first inner accommodation space 11 so that the imaging ultrasonic probe 40 can smoothly slide to the positioning point. Next, by dialing the at least one button 60, the imaging
ultrasonic probe 40 can be tightly coupled with the main body 10 of the focused ultrasound probe, as shown in Fig. 7C.
Next, please refer to Fig. 8 and Fig. 9 of the present invention, which is another preferred embodiment provided by the present invention, showing a longitudinal sectional view and an exploded view of the front end portion 20 which can adjust the depth distance. The front end portion 20 is composed of a front end cover 21, a coupling ring 23, and a rotary ring 24. Wherein, the front end cover 21 includes two longitudinal grooves 211 symmetrically disposed on the side wall of the front end cover 21, two helical grooves 212 and an O-ring groove 213. The coupling ring 23 is provided with two transverse grooves 231 which are symmetrically disposed and penetrate the side walls of the coupling ring 23 and are equally symmetrically arranged and penetrate through the two through holes 232 of the side wall of the coupling ring 23 and one of the conductive substance opening 25 allowing the transfer of the conductive substance into and out of circulation. Finally, the rotary ring 24 is provided with two inner recessed slots 241 on the inner side of the side wall thereof. The front end cover 21 is provided with an O-ring 216 above the O-ring groove 213 and provided on the inner side of the coupling ring 23, and is guided by a short convex shaft 214 through the two through holes 232 and the two longitudinal grooves 211 which are provided on the outer side of the front end cover 21 and the coupling ring 23. The rotary ring 24 passes through the two transverse grooves 231 and setting against the two helical grooves 212 through a long convex shaft 215 and is fitted over the two inner recessed grooves 241. With the above-described arrangement, the position of the front end cover 21 of the front end portion 20 can be adjusted to change the space size of the second inner accommodation space 22 inside the front end cover 21 so as to achieve an adjustable focusing depth of the focused ultrasonic probe.
In the preferred embodiment, a rotary rubber sleeve (not shown in the figures) may be further provided on the outside of the rotary ring 24, as described in the preceding paragraph.
By setting of the rotary rubber sleeve 242, the higher friction force of the rotary ring 24 can be provided to achieve a better slip effect and operation feel to enhance the use quality of the apparatus of combining an imaging ultrasonic probe and a focused ultrasound probe.
Next, in addition to the foregoing Fig. 8 and 9, please refer to Fig. 9 and 10 of the present invention, which is a further preferred embodiment of the present invention. The Figs show a continuous side view of the front end portion 20 when adjusted. According to the rotation of the rotary ring 24, the long convex shaft 215 fixed to the rotary ring 24 will be rotated along the transverse groove 231 on the coupling ring 23 and simultaneously the helical groove 212, which is disposed on the front end cover 21, to make the front end cover 21 move up or down. In this example, the helix on the front cover 21 is a right-hand spiral, so that when the rotary ring 24 rotates to the right, the front end cover 21 will move vertically downward. When the rotary ring 24 is rotated to the left, the front end cover 21 is moved vertically upward. However, if the helix on the front end cover 21 is a left-hand helix, the direction in which the front end cover 21 is moved will be opposite to the aforementioned right-hand spiral. On the other hand, in order to ensure smooth and vertical movement of the front end cover 21 during movement, the short convex shaft 214 on the coupling ring 23 will guide the front end cover 21 to move on a vertical track. At the same time, the two longitudinal grooves 211 on the front end cover 21 are moved on the short convex shaft 214. Wherein the stroke size of the vertical track is the dimensional distance from which the front end cover moves up and down, and thus the accommodating volume of the second inner accommodation space 22 is changed so that the conductive substance opening 25 for allowing the conducting substance to flow in and out is filled with the conductive substance. Whereby the depth distance between the focus of the focused ultrasound probe 30 and the therapeutic target in the observed image can be adjusted.
In view of the above, the apparatus provided by the present invention is capable of tightly combining the imaging ultrasonic probe and the focused ultrasonic probe to reduce the operating cost and space requirement of the user. The apparatus provided by the present invention can simultaneously carry out the image ultrasound scanning and focusing the treatment of the ultrasonic probe. On the other hand, the apparatus provided by the present invention is not difficult to achieve the process of combining the imaging ultrasonic probe and the focused ultrasonic probe, and the separation process is also easy. The apparatus provided by the present invention has both functional and convenient, and does break through the difficulties in the prior art, enhances the technical level of the related field, and has the necessary requirements for the patent application.
The foregoing is merely illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the invention. Any changes and modifications in the form, construction, character and spirit described in the patent application of the present invention are intended to be included within the scope of the present application.