The present invention belongs to the technical field of medical instruments, relates to a high-intensity focused ultrasound treatment apparatus, and particularly relates to an ultrasound treatment clamp.
Ultrasound, especially high-intensity focused ultrasound has been widely used in medical industry for diagnosis and treatment on a patient. A high-intensity focused ultrasound therapy is to focus the ultrasound on the diseased part, on which high-intensity and continuous ultrasonic energy is formed and thereby instantaneous thermal effect (60° C.˜100° C.), cavitation effect, mechanical effect and acoustic chemical effect are produced to destroy the cell membrane and nuclear membrane and coagulate the protein. Therefore, it can selectively cause a coagulative necrosis of the diseased tissue and accordingly deprives the diseased part of capability of proliferation, infiltration and metastasis. Furthermore, the high-intensity focused ultrasound therapy is not only used in tumor resection but also in treatment of other diseases, and it has been approved in clinical uses.
U.S. Pat. Nos. 5,882,302, 5,993,389 and 6,083,159 provide an ultrasound apparatus for surgery in the internal hemostasis by using a high-intensity focused ultrasound. U.S. Pat. Nos. 6,007,499 and 6,432,067 also provide a surgical ultrasound apparatus using a high-intensity focused ultrasound to form narcotic tissue regions before a surgery so as to avoid the bleeding of vasalium when performing surgery. The ultrasound transducer of this apparatus generates the focused ultrasound and emits continuously to a certain point of the diseased part. The treatment depth of the focal point can be varied by changing the positions of the ultrasound transducer.
The ultrasound apparatuses disclosed by the above-mentioned US patents can, to some extent, provide a hemostasis in the resection of tissue having a highly vascularized constitution, but there are some limits on the use of these apparatuses. Firstly, the operator needs to continuously move the large-sized ultrasound transducer by hand in the same angle according to different surgical incisions, so the operation procedure is very complex and also it is liable to cause mishandlings. Secondly, when the tissue to be treated is soft and incompact, the pressure generated by the apparatuses as mentioned above on the target tissue is not enough, so it is impossible to control the target tissue effectively, and if the target tissue can not be controlled, the ultrasonic energy can not arrive at the target tissue and the expected hemostasis can not be achieved. Thirdly, because the ultrasound apparatuses mentioned above can form only one focal point within the diseased part and usually the ultrasonic energy is attenuated on the acoustic path, it takes a lot of time to cause a coagulative necrosis of the relatively thick tissue (for example, the liver and spleen) during treatment and accordingly the cost is increased.
Aiming at the disadvantages in the prior art as mentioned above, the technical problem is solved in the present invention by providing an ultrasound treatment clamp with a compact structure, a convenient operation, a low treatment cost, a capability of quickly causing a coagulative necrosis of the diseased part to avoid excessive lose of blood of a patient, and an abroad use.
The technical solution to solve the technical problem in the present invention is as follows: the ultrasound treatment clamp comprises ultrasound therapy applicators and handles connected to the ultrasound therapy applicators. The handles are clamp-shaped. Two ultrasound therapy applicators with their central axes overlapping each other are mounted face to face on the two clamps of the clamp-shaped handles respectively. A parallel moving mechanism for keeping two ultrasound therapy applicators in parallel when moving along with the clamps is connected between two clamps.
Said ultrasound therapy applicator further comprises connection tubes, one end of which is connected to the ultrasound therapy applicator and the other end is connected to the clamp of the clamp-shaped handle. Said parallel moving mechanism is connected between the two opposite connection tubes.
Preferably, said connection tube is connected to the clamp of the clamp-shaped handle through a joint. There are passages for fluid and electrical signals at one end connecting the connection tube and the joint. Said passages for fluid and electrical signals are connected to the ultrasound therapy applicator. The passage for fluid is used as a cooling passage in the present invention to cool the ultrasound transducer during treatment. The cooling fluid is usually liquid water.
In the practical use, because the sizes and shapes of the target tissue are different, the joint can be connected to the ultrasound therapy applicator by a rotating joint. Because the rotating joint can rotate freely, the ultrasound therapy applicator can rotate freely on the rotating joint, that is, it can focus the ultrasound transversely or longitudinally.
The parallel moving mechanism enables the focal regions of two ultrasound therapy applicators to be in the same straight line in any opening degree of the treatment clamp, i.e. it can keep the central axes of two applicators overlapping each other all along. Thus, when high-intensity ultrasound energy is needed for a treatment, the ultrasound energy can be accumulated, i.e. two applicators apply ultrasound energy simultaneously to the same diseased part, so the therapeutic effects can be enhanced. During treatment, the time to cause a coagulative necrosis of the thick diseased tissue (for example, the liver or spleen) by using the applicators in the present invention is greatly shorter than that by using the ultrasound applicators in the prior art, so the treatment cost is saved. Meanwhile, the ultrasonic energy is emitted from more than one ultrasound applicator, so other internal organs will not be injured.
Said parallel moving mechanism may comprise a telescoping mechanism in a parallelogram formed by a plurality of link blocks hinged with each other. There is a sliding sleeve on the connection tube for sliding back and forth. The link block at one corner of the outer part of the parallel moving mechanism is hinged with the sliding sleeve and the link block at the other corner of the outer part is fixed on the clamp.
Said parallel moving mechanism may be telescopic pipe components comprising big hollow pipes and small hollow pipes in different diameters, said small hollow pipes are encased in the big ones and can extend and slide.
Said ultrasound therapy applicator comprises an ultrasound transducer and a fluid container. The ultrasound transducer is placed in the fluid container and an acoustic transparent membrane is fixed at the open part of the container by an airtight device.
Wherein, said fluid is preferably the degassed water. Said ultrasound transducer can adopt focusing or non-focusing ultrasound transducers according to the practical needs. Thus, the apparatus of the present invention can be used widely to treat other diseases, such as tumor, skin diseases and etc.
A bracket is provided in said fluid container and the ultrasound transducer is placed on the bracket. Preferably, a focal distance adjusting device is provided on the fluid container further. One end of said focal distance adjusting device extending into the fluid container is connected to the bracket.
Said focal distance adjusting device may include a screw connected to the bracket, a seal ring and a seal nut covered on the screw, an adjusting knob on the seal nut and a fixing bolt on the adjusting knob. The seal ring clings to the outside wall of the fluid container.
A slot for mounting an ultrasound therapy guiding assembly is provided in said ultrasound transducer. Said guiding assembly may be a semiconductor light device or a B-mode ultrasound probe. The semiconductor lighting device is fixed in the slot and is used to guide the ultrasound transducer to perform an accurate treatment. Before the treatment, according to the position of light beams emitted from the semiconductor lighting device, the operator can locate the ultrasound applicator to the surface of the target tissue, and the intersection point of the focal point/line of the therapy applicator and light beams of the diode is confirmed. Also an ultrasonic imaging apparatus such as a B-mode ultrasound probe can be fixed in that slot to image the target tissue and guide the ultrasound therapy.
In order to avoid a heat injury to the target tissue, said ultrasound therapy applicator further comprises a temperature sensor fixed on the opposite side of said two ultrasound transducers (i.e. the side of the target tissue clamped by the ultrasound transducers). Because a membrane type temperature sensor is light and thin, the temperature sensor is preferably the membrane type temperature sensor.
A locker for fixing the handles may be provided between the two handles. Thus, after the parallel moving mechanism driven by the handles extends to the predetermined position, the locker can be used to fix the current position of two handles to make convenience for the treatment.
In the present invention, before the resection of tissue having a highly vascularized constitution (for example, spleen, kidney, liver and etc.), the high-intensity focused ultrasound is applied to cause a coagulative necrosis area between the area to be resected and the area to be reserved. Therefore, during the resection of tissues such as liver, the coagulative necrosis area is taken as the area to be resected by a surgical knife. The structure of the treatment clamp in the present invention offers an easy manual operation by an operator. Through an operation of two clamps, two ultrasound therapy applicators can firmly clamp the target tissue. Thus, the target tissue can be controlled effectively. The resection will not cause excessive blood loss, so the possibility of blood transfusion is reduced and also the occurrence of complications after surgery is decreased. Moreover, the two ultrasound therapy applicators of the present invention can work simultaneously, by which the time to cause a coagulative necrosis of the incisions is shortened and the effect of the hemostasis of the target tissue is ensured.
The present invention also has other advantages such as possessing a compact structure, low treatment cost and abroad uses (the ultrasound transducer with different specifications can be chosen according to different needs).
Wherein: 1-Handle 2-Pin 3-Connection tube 4-Sliding sleeve 5-Joint 6-First therapy applicator 7-Second therapy applicator 8-Fluid container 9-Ultrasound transducer 10-Bracket 11-Acoustic transparent membrane 12-Cover board 13-Bolt 14-Focal distance adjusting device 141-Screw 142-Seal ring 143-Seal nut 144-Adjusting knob 145-Fixing bolt 15-Link block 16-Slot 17-Semiconductor light device 18-B-mode ultrasound probe 19-Temperature sensor 20-Telescopic pipe components 21-Single telescopic pipe 22-Rotating joint 23-Locker 24-Small multiple outlets hose 25-Mainframe control system 251-Display 252-Operation knob 253-Control unit 254-Water pump 255-Water tank 256-Truckle 257-Signal wire 258-Return pipe 259-Inlet water pipe 26-Big multiple outlets hose
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The ultrasound therapy applicator comprises an ultrasound transducer 9 and a fluid container 8. The ultrasound transducer 9 is placed in the fluid container 8. An acoustic transparent membrane 11 is fixed on the open part of the fluid container 8 by an airtight device.
The ultrasound transducer 9 can adopt focusing or non-focusing ultrasound transducers. The focusing transducer is mainly used for hemostasis during operations and for treating deep-bedded diseased part in the tissue, for example, hepatic carcinoma, bone carcinoma, deep-bedded myosarcoma and etc. The focusing ultrasound transducer may be a single circular piezoelectric ceramic crystal with a lens for focusing, or a single spherical surface or a single arc surface piezoelectric ceramic crystal, or a piezoelectric ceramic crystal array comprising a plurality of piezoelectric ceramic crystals with the same size or different sizes, the driving mode of which may be a single-channel signal one or a multi-channel signal one in phase control. The non-focusing ultrasound transducer is mainly used for skin diseases and the diseased parts in the upper surface of skin. The non-focusing ultrasound transducer may be a single flat piezoelectric ceramic crystal, or a piezoelectric ceramic crystal array comprising a plurality of flat piezoelectric ceramic crystals with the same size or different sizes, the driving mode of which may be a single-channel signal one or a multi-channel signal one in phase control.
Also a slot 16 is provided in said ultrasound transducer 9, and a semiconductor lighting device or a B-mode ultrasound probe for guiding an ultrasound therapy can be fixed in the slot 16. A locker for fixing the handles may be provided between the two handles.
Preferably, said ultrasound therapy applicator further comprises a temperature sensor 19 fixed on the side of the target tissue clamped by the two ultrasound transducers.
The ultrasound therapy applicator further comprises a connection tube 3, one end of which is connected to the fluid container 8 and the other end is connected to the clamp of the clamp-shaped handle 1 through a joint 5. Said parallel moving mechanism is connected between the two opposite connection tubes 3. There are passages for fluid and electrical signals at one end where the connection tube 3 and the joint 5 are connected. Said passages for fluid and electrical signals are both connected to the ultrasound therapy applicator.
The present invention will be further explained below with reference to the preferred embodiments and accompanying drawings.
The flowing embodiments are unrestrictive embodiments of the present invention.
As shown in
Each of the first therapy applicator 6 and the second therapy applicator 7 comprises a fluid container 8, an ultrasound transducer 9, an acoustic transparent membrane 11, a cover board 12 and a connection tube 3. The connection tube 3 is connected to the ultrasound transducer 9 at one end and is connected to the clamp of the handle 1 at the other end. The ultrasound transducer 9 is placed in the fluid container 8. The acoustic transparent membrane 11 is fixed on the open part of the fluid container 8 through an airtight device, i.e. the cover board 12. The fluid container 8 is full of degassed water. In this embodiment, the fluid is the purified water. The ultrasound transducer adopts a single spherical surface piezoelectric ceramic crystal which can focus and is used to treat a deep-bedded diseased part with a small size.
As shown in
The focal distance adjusting device 14 includes a screw 141, a seal ring 142, a seal nut 143, an adjusting knob 144 and a fixing bolt 145. The end with a lug boss of the screw 141 is connected to the bracket 10 by thread connection and the other end of the screw 141 goes through the fluid container 8 and is connected to the seal nut 143. The seal nut 143 is connected to the adjusting knob 144. The adjusting knob 144 is fixed by the fixing bolt 145. In order to ensure a seal, the seal ring 142 is installed outside where the screw 141 goes through the external wall of the fluid container 8. When rotating the adjusting knob 144, the bracket 10 moves back and forth under the drive of the screw 141 and accordingly the ultrasound transducer 9 placed on the bracket 10 moves back and forth. This kind of ultrasound transducer with the focal distance adjusting device can satisfy the different treatment depths of the diseased part if the tissue has the same thickness.
The ultrasound transducers 9 in the first therapy applicator 6 and the second therapy applicator 7 can have the same frequency or different frequencies and the two ultrasound transducers are driven respectively by two sets of driving devices. According to the practical conditions, the treatment can use only one applicator or two applicators simultaneously.
In order to ensure two ultrasound therapy applicators keeping in parallel in any opening degree of the clamps of the ultrasound treatment clamp of the present embodiment, that is, to ensure the central axes of two applicators being in the same line at any time, the parallel moving mechanism is provided between two clamps of the handle 1.
There are many methods to realize the parallel moving mechanism. As shown in
Because the first therapy applicator 6 and the second therapy applicator 7 are respectively fixed on the two opposite connection tubes 3, both the two connection tubes 3 are always keeping in parallel whatever opening degrees the clamps of the handle 1 are in. Thus, the first therapy applicator 6 and the second therapy applicator 7 can always move in parallel. Since the clamps are hinged with the joints 5 connected to the ultrasound therapy applicators, the opening and closing of the handle 1 form a power supply for the movement in parallel of the two ultrasound therapy applicators.
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In this embodiment, all the moving joints of the treatment clamp adopt a pin 2 connection. The purpose of adopting a pin connection is to ensure that there is only one-dimension rotation at the moving joint and the moving in other dimensions is limited, therefore, the twist, vibration and etc. will not be produced in the present invention so that the ultrasound therapy applicators keep their balance all the time when the clamps open or close.
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The other structures and the using methods of the present embodiment are the same as those in the embodiment 1.
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In this embodiment, the ultrasound transducer 9 adopts a piezoelectric ceramic crystal array comprising of multiple piezoelectric ceramic crystals with the same size or different sizes. The driving mode of this array is a multi-channel signal one in phase control, thus, the operator may drive the ultrasound transducer 9 according to the actual conditions such as the depth of the diseased part so that the focal point can be more precise and the ultrasound energy is more appropriate.
When the ultrasound treatment clamp of the present invention is used to combine with the mainframe control system 25, one set of the signal wires 257 provides the electric driving signals respectively to the two ultrasound transducers 9. The other set of the signal wires 257 provides the electric driving signals respectively to the two semiconductor lighting devices 17.
The other structures and the using methods of the present embodiment are the same as those in the embodiment 2.
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When the ultrasound treatment clamp is used to combine with the mainframe control system 25, the B-mode ultrasound probe 18 is used to image the target tissue and the target tissue is treated on the basis of imaging results.
The other structures and the using methods of the present embodiment are the same as those in the embodiment 2.
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Meanwhile, a locker 26 is added to the handles 1. When the parallel moving mechanism extends under the drive of the handles 1 to the appropriate position, the locker 26 can be used to fix the position of two handles 1.
The other structures and the using methods of the present embodiment are the same as those in the embodiment 2.
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In this embodiment, the ultrasound transducer 9 adopts non-focusing circular piezoelectric ceramic crystals for skin diseases, the diseased parts in the upper surface of skin and etc. As shown in
The other structures and the using methods of the present embodiment are the same as those in the embodiment 1.
In this embodiment, the first therapy applicator 6 and the second therapy applicator 7 are respectively fixed on two front ends of the two clamps of the handle 1 by the joints 5. The two ends of the telescopic pipe components 20 are connected respectively to the two opposite connection tubes 3. When the telescopic pipe components 20 extend under the drive of the handle 1, the first ultrasound therapy applicator 6 and the second ultrasound therapy applicator 7 keep moving in parallel all the time.
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The other structures and the using methods of the present embodiment are the same as those in the embodiment 2.
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Number | Date | Country | Kind |
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200610001632.5 | Jan 2006 | CN | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/CN06/01716 | 7/7/2006 | WO | 00 | 7/17/2008 |