The specific embodiment
The invention provides a kind of like this apparatus and method, these apparatus and method are used to utilize ultrasonic medical equipment that ultrasonic energy is propagated along the bending of (about) this ultrasonic medical equipment, with the ablating biological material.The ultrasonic probe of described ultrasonic medical equipment inserts in the insertion point of vascular system, and is navigated along one or more bendings of this vascular system, and is arranged to be communicated with biomaterial.The transducer of described ultrasonic medical equipment can drive this ultrasonic probe in wide frequency ranges, encouraging the lateral resonance of this ultrasonic probe, and make the biomaterial execution maximization of this ultrasonic probe.By changing the operation frequency of ultrasonic medical equipment of the present invention, increased the effective coverage that biomaterial melts.
Here used following noun and definition:
" the melting (ablate) " of using here refers to remove, removes, destroys or takes away biomaterial." the melting (ablation) " of using here refers to removing, remove, destroy or taking away of biomaterial.
Here " antinodal points (anti-node) " that uses refers to be positioned at or near the ceiling capacity band of the emission of the specific location ultrasonic probe on the longitudinal axis of ultrasonic probe.
Here " node (node) " that uses refers to be positioned at or near the least energy band of the emission of the specific location ultrasonic probe on the longitudinal axis of ultrasonic probe.
Here " probe (probe) " that use refers to a kind of like this device, and this device can resolve into effective cavitation energy (cavitational energy) (by a plurality of nodes and the definition of a plurality of antinodal points along probe " active section (active section) ") along the propagation of the probe longitudinal axis and with specific resonance with energy with the energy of source of ultrasonic energy emission.
Here " biomaterial (the Biological Material) " that uses refers to the set of material, comprise similar groups of cells (a group of similar cells), blood clot in the vascular, the infraction thing, deposit, fibrin, calcified plaque (calcified plaque), the calcium deposit, infraction thing deposition, atheromatous plaque (atherosclerotic plaque), lipidosis, fatty tissue, the atherosclerosis accumulation of cholesterol, thrombosis, fibrous material is piled up, stricture of artery (arterial stenoses), mineral, the high-moisture percentage tissue, platelet, cell debris (cellular debris), refuse and other infraction material, but be not limited thereto.
Here " laterally (transvers) " that use refers to that the vibration of probe is not parallel to the probe longitudinal axis.Here " shear wave (the transverse wave) " that uses is a kind of ripple of propagating along probe, and the perturbation direction and the wave vector at a plurality of somes place of its medium are not parallel.
Here " vascular (vasculature) " that use refers to whole blood supply blood circulation, comprises Venous system, Arterial system and relevant conduit, tremulous pulse, vein, capillary tube, blood and heart.Arterial system is the blood-transmitted that carries oxygen and nutrient to be given the mechanism of tissue.Venous system is to carry the blood-transmitted of carbon dioxide and metabolism by-product with excretory mechanism.
Shown in the Reference numeral of Fig. 1, the ultrasonic probe of the ultrasonic medical equipment 11 of frequency conversion drive substantially in vascular system along crooked 54 deflections.Ultrasonic medical equipment 11 comprises ultrasonic probe 15, and this ultrasonic probe 15 is connected in source of ultrasonic energy or the generator 99 that is used to produce ultrasonic energy.Handle 88 comprises that near-end 87 and far-end 86, one transducers (transducer) are enclosed in this handle 88.
Fig. 2 shows the preferred embodiment of ultrasonic probe 15 of the present invention, and wherein the diameter of ultrasonic probe reduces via changeover portion 82 to second definition spacers 28 from the first definition spacer 26 along the longitudinal axis of ultrasonic probe 15.Ultrasonic probe 15 comprises near-end 31, ends at the far-end 24 of needle point 9 and the longitudinal axis between near-end 31 and the far-end 24.The adapter 33 that totally is shown in Fig. 2 is joined together the near-end 31 of probe 15 and the described transducer in the handle 88.In one embodiment of the present invention, described adapter is the system that installs and removes fast.United States Patent (USP) NO.6 the assignee, 695,782 and the U.S. Patent application No.10/268 of assignee subject to approval (co-pending), 487 and U.S. Patent application No.10/268, in 843 the patent application, described a kind of ultrasonic medical equipment with quick mounting or dismounting unloading system, above-mentioned document has also been described described quick mounting or dismounting system, and thus all these patents and patent application by quoting in this merging.
The far-end that described transducer has the near-end that engages with source of ultrasonic energy 99 and is engaged in the near-end 31 of ultrasonic probe 15, described transducer passes to ultrasonic probe 15 with ultrasonic energy.Described transducer generally is also referred to as driver.Connector 93 and connecting line 98 join source of ultrasonic energy 99 on the described transducer to.
Fig. 3 shows the alternative embodiment of ultrasonic probe 15 of the present invention.In embodiments of the invention shown in Figure 3, the diameter of ultrasonic probe 15 is even substantially to the far-end 24 of ultrasonic probe 15 from the near-end 31 of ultrasonic probe 15.
In a preferred embodiment of the present invention, ultrasonic probe 15 is cable (wire).In an embodiment of the present invention, ultrasonic probe 15 is elongated.In one embodiment of this invention, the diameter of ultrasonic probe 15 changes in the mode bigger than the spacer of two definition.In one embodiment of this invention, the changeover portion 82 of ultrasonic probe 15 is gradually thin, 24 to change diameter gradually along the longitudinal axis of ultrasonic probe 15 from near-end 31 to far-end.In another embodiment of the present invention, the wave band 82 of crossing of ultrasonic probe 15 is stepped, 24 to change diameters along the longitudinal axis of ultrasonic probe 15 from near-end 31 to far-end.It will be recognized by those skilled in the art the spacer and the changeover portion of a definition arbitrarily can be arranged, and changeover portion can have arbitrary shape known in the art.These spacers and changeover portion all are covered by in the spirit and scope of the present invention.
In one embodiment of this invention, 24 change gradually occurs at least one changeover portion 82 to described diameter from near-end 31 to far-end, and each changeover portion 82 has approximately equalised length simultaneously.In another embodiment of the present invention, 24 change gradually occurs in a plurality of changeover portions 82 to described diameter from near-end 31 to far-end, and each changeover portion 82 has different length.Changeover portion 82 refers to the section of diameter from first vary in diameter to second diameter.
In a preferred embodiment of the present invention, ultrasonic probe 15 has little diameter.In a preferred embodiment of the present invention, the cross section sub-circular of ultrasonic probe 15.In another embodiment, ultrasonic probe 15 is not circular to the small part cross section.Comprising that ultrasonic probe 15 that far-end has a cable of on-circular cross-section can navigate passes vascular system.The ultrasonic probe 15 that comprises flat cable is easy to handle in vascular system.In another embodiment of the present invention, the shape of cross section of ultrasonic probe 15 comprises rectangle, trapezoidal, oval, triangle, have the circular of flat part (flat spot) and similar cross section, but is not limited thereto.It will be recognized by those skilled in the art that other cross-sectional geometry known in the art will be covered by in the spirit and scope of the present invention.
In one embodiment of this invention, the diameter of the far-end 24 of ultrasonic probe 15 is 0.004 inch approximately.In another embodiment of the present invention, the diameter of the far-end 24 of ultrasonic probe 15 is 0.015 inch approximately.In another embodiment of the present invention, the diameter of the far-end 24 of ultrasonic probe 15 changes between about 0.003 inch and about 0.025 inch.It will be recognized by those skilled in the art, the diameter of the far-end 24 of ultrasonic probe 15 can be than described about 0.003 inch little, can be than described about 0.025 inch big, can be between described about 0.003 inch and described about 0.025 inch, and be covered by in the spirit and scope of the present invention.
In an embodiment of the present invention, the diameter of the near-end 31 of ultrasonic probe 15 is 0.012 inch approximately.In another embodiment of the present invention, the diameter of the near-end 31 of ultrasonic probe 15 is 0.025 inch approximately.In another embodiment of the present invention, the diameter of the near-end 31 of ultrasonic probe 15 changes between about 0.003 inch and about 0.025 inch.Those skilled in the art will recognize that, ultrasonic probe 15 can the diameter of near-end 31 can be than described about 0.003 inch little, can be than described about 0.025 inch big, can be between described about 0.003 inch and described about 0.025 inch, and be covered by in the spirit and scope of the present invention.
Needle point 9 can be an arbitrary shape, comprises circular, crooked, spheric or bigger shape, but is not limited thereto.In a preferred embodiment of the present invention, needle point 9 is level and smooth, to prevent to damage the vascular system of human body.In one embodiment of this invention, source of ultrasonic energy 99 is mechanical parts (physical part) of ultrasonic medical equipment 11.In another embodiment of the present invention, source of ultrasonic energy 99 is not ultrasonic medical equipment 11 whole needed parts.Ultrasonic probe 15 is used for ablating biological material and can be processed after use falling.In a preferred embodiment of the present invention, ultrasonic probe 15 is for a disposable use of patient.In a preferred embodiment of the present invention, ultrasonic probe 15 is disposable.In a preferred embodiment of the present invention, ultrasonic probe 15 can repeatedly use.
Ultrasonic probe 15 by operation under transverse mode but does not produce damping to support the material of oscillation crosswise to design, construct and form when the deflection thus to horizontal supersonic vibration.In a preferred embodiment of the present invention, ultrasonic probe 15 contains titanium or titanium alloy.Titanium be a kind of firm, flexible, low-density, low ray impermeability and easily processing, as the metal of structural material.Titanium and alloy thereof have the excellent anti corrosivity under many environment and have good high-temperature behavior.In a preferred embodiment of the present invention, ultrasonic probe 15 contains titanium alloy T i-6Al-4V.The percentage by weight of the element of formation Ti-6Al-4V and the representative element of Ti-6Al-4V is titanium (about 90%), aluminum (about 6%), vanadium (about 4%), ferrum (maximum about 0.25%) and oxygen (maximum about 0.2%).In another embodiment of the present invention, ultrasonic probe 15 contains rustless steel.In another embodiment of the present invention, ultrasonic probe 15 contains stainless steel alloy.In another embodiment of the present invention, ultrasonic probe 15 contains aluminum.In another embodiment of the present invention, ultrasonic probe 15 contains aluminium alloy.In another embodiment of the present invention, ultrasonic probe 15 contains titanium and stainless combination.
In an embodiment more of the present invention, ultrasonic probe 15 comprises superelastic alloy.Even when crooked or stretching, after removal was stressed, superelastic alloy was with reinstatement.Ultrasonic probe 15 can comprise superelastic alloy known in the art, and this superelastic alloy comprises nickel-titanium superelastic alloy and Nitinol (Nitinol), but is not limited thereto.Nitinol belongs to intermetallic material family, and it comprises the almost equal nickel and the mixture of titanium.The character of described material can usually be adjusted or regulate by adding other yuan.Nitinol does not have titanium hard, and is easy to handle in vascular system.Nitinol has shape memory and the super characteristic that plays.What shape memory effect was described is that the plastic deformation sample is by the restorable process of heating.This is the result who is called the crystallization phase transformation of Thermoelastic Martensitic Transformation in A.Below transition temperature, Nitinol is a martensite.The corrosion resistance of Nitinol excellence, biocompatibility and unique mechanical characteristic make it be applicable to very much armarium.It will be recognized by those skilled in the art that ultrasonic probe can comprise many other metals known in the art, and is covered by in the spirit and scope of the present invention.
Physical characteristic of ultrasonic probe 15 (that is, length, shape of cross section, size etc.) and material behavior (that is, yield strength, modulus etc.) are chosen to be used for operation ultrasonic probe 15 under transverse mode.In one embodiment of this invention, the length of ultrasonic probe 15 is between about 30 centimetres to about 300 centimetres.Those skilled in the art will recognize that the length of ultrasonic probe can be than described about 30 centimetres little, can be than described about 300 centimetres big, can be between about 30 centimetres and about 300 centimetres, and be covered by in the spirit and scope of the present invention.
Handle 88 surrounds at the near-end 31 of ultrasonic probe 15 and the described transducer between the adapter 93.Described transducer can comprise horn (horn), electrode, insulator (insulator), back tightening nut (backnut), packing ring, piezoelectric microphones and piezoelectric actuator, but is not limited thereto.Described transducer converts the electric energy that source of ultrasonic energy 99 provides to mechanical energy.Described transducer can engage with ultrasonic probe 15 to constrain in near-end 31 places fully, to form the sound material (acoustical mass) of the ultrasonic energy propagation that source of ultrasonic energy 99 can be provided.Source of ultrasonic energy 99 provides the signal of telecommunication for the described transducer that is positioned at handle 88.
The Medical Technologist enters in the vascular system 44 by the insertion point on the vascular system 44.A device (device) that includes, but is not limited to the vascular conductor can be used for producing the insertion point to enter vascular system 44 on vascular system 44.Assignee's the U.S. Patent application No.10/080 that subjects to approval, 787 have described the vascular conductor that uses with ultrasonic probe, and whole this application by quoting in this merging.
Ultrasonic probe 15 enters vascular system 44 by the insertion point on the vascular system, and ultrasonic probe 15 moves to the biomaterial 16 that approaches in the vascular system 44.When ultrasonic probe 15 moved to the biomaterial 16 that approaches in the vascular system 44, the crooked route (tortuous paths) of vascular system 44 was passed in ultrasonic probe 15 bendings.The rigidity that ultrasonic probe 15 has has given ultrasonic probe 15 flexibilities so that the crooked route of ultrasonic probe 15 deflections, deflection, crooked vascular system 44 by human body.Ultrasonic probe 15 can be crooked, deflection and deflection is with the biomaterial 16 in the vascular system 44 of the human body that arrives at other mode and be difficult to arrive at.By move along biomaterial 16, scan, crooked, reverse or rotary ultrasonic probe 15, ultrasonic probe 15 be placed to biomaterial 16 be communicated with.It will be recognized by those skilled in the art that mobile ultrasonic probe is covered by in the spirit and scope of the present invention with the many methods that are communicated with biomaterial.
Depend on source of ultrasonic energy 99 and described driver, bending ultrasonic probe 15 will influence the function and the performance of ultrasonic probe 15.Depend on special bending position and operation frequency, ultrasonic energy may not be propagated along bending, to allow the active section ablating biological material 16 along ultrasonic probe 15.Yet, to propagate with ablating biological material 16 along bending in order to make ultrasonic energy, described operation frequency needs to change.
For example, when crooked route in the vascular system is passed in the ultrasonic probe bending, utilize resonance driver and limited when melting the intravital biomaterial of people with the prior art mechanism of longitudinal vibration mode operation.Described utilization resonance driver and enough ultrasonic energies can not be delivered to the target area of biomaterial with the prior art mechanism of longitudinal vibration mode operation.The bending ultrasonic probe can produce reflection in the maximum curvature position, if described driver is a resonance device, then this reflection and described driver interfere.The bending ultrasonic probe can cause the excitation of longitudinal vibration mode or lateral vibration mode.If ultrasonic probe bends to reflection is returned with positive relation (right phase relationship), the longitudinal resonance of then described reflected energy and described driver is interfered or can structurally be added in the described longitudinal resonance of described driver (constructively), and this just produces the ultrasonic medical equipment with the vertical pattern operation.When the crooked mobile ultrasonic probe 15 in the body vessels system, ultrasonic probe 15 will be crooked at an arbitrary position.By at described optional position bending ultrasonic probe 15, will there be a frequency, on ultrasonic probe 15, produce ideal standing wave (standing wave) by this frequency.Resonance condition is to be feature to produce standing wave on ultrasonic probe 15.
Prior art mechanism is the resonator system that comprises piezoelectric actuator, wherein produces operation under the resonant frequency of piezoelectric actuator.By piezoelectric actuator, owing to can not produce enough physical energies in other frequency, so under other frequency, can not produce operation.Prior art mechanism has also utilized the harmonic wave (for example second harmonic, triple-frequency harmonics) of resonant frequency.Yet operation still is under the resonant frequency, only allow thus or approach the energy that will produce under the resonant frequency of described piezoelectric actuator.
Ultrasonic medical equipment 11 of the present invention comprises the operation of frequency conversion drive and lateral vibration mode.Ultrasonic medical equipment 11 of the present invention comprises transducer, and this transducer has the ability that drives ultrasonic probe 15 in wide frequency ranges, is created in the power in the wide frequency ranges thus.As discussed above, prior art mechanism utilizes the piezoelectric actuator of operating under resonant frequency to drive ultrasonic medical equipment.Ultrasonic medical equipment 11 of the present invention comprises the wide-band transducer of operating under the frequency at the various not resonant frequency places in ultrasonic probe 15.Ultrasonic medical equipment 11 of the present invention is at the lateral resonance of the simultaneous excitation ultrasonic probe 15 of the longitudinal resonance of avoiding ultrasonic probe 15.
Ultrasonic medical equipment of the present invention 11 allows to carry out the frequency conversion drive operation under a plurality of frequency ranges, therefore reflection may be controlled to not and driver homophase or out-phase.So, do not interfere with described driver.Ultrasonic medical equipment of the present invention allows frequency shift avoiding the longitudinal resonance of ultrasonic probe 15, and the lateral resonance of excitation ultrasound probe 15 only.Ultrasonic medical equipment 11 of the present invention allows to change operation frequency so that power is propagated the ablation effect that maximizes 15 pairs of biomaterials of ultrasonic probe along bending.The transmission that ultrasonic medical equipment 11 of the present invention allows to make operation frequency to change so that enough ultrasonic energy to be provided comes the ablating biological material.
The frequency conversion drive operation of ultrasonic medical equipment 11 of the present invention is carried out to the longitudinal vibration mode of avoiding a small amount of (sparsepopulation) and preferentially excites the lateral vibration mode of a large amount of (large population) so that the maximum effect that biomaterial melts.Because a lot of lateral vibration modes are arranged, so by the waveform on the ultrasonic probe 15 that changed frequency shift, thus for exciting lateral vibration mode to create chance.
Ultrasonic medical equipment 11 of the present invention comprises the wide-band transducer of the resonant frequency in the frequency range of avoiding being concerned about.The resonance opposite with the prior art transducer, that wide-band transducer of the present invention is not locked in resonant frequency and drives under resonant frequency.Transducer with resonance provides uneven power output in wide frequency ranges.Wide-band transducer of the present invention allows the even power output in the frequency range of ultrasonic medical equipment 11 operations.In preferential embodiment of the present invention, described transducer is magnetostriction (magnetostrictive) _ mechanism.For identical given horsepower input, described magnetostriction mechanism allows bigger displacement, can be for the usefulness of no resonance transducer.In another embodiment of the present invention, described transducer is to be similar to voice coil loudspeaker voice coil (voicecoil) mechanism that uses in conventional audio speaker.In another embodiment of the present invention, described transducer is a pneumatic mechanism.Those skilled in the art will recognize that described transducer can be the many mechanisms that any resonance is avoided in the frequency conversion drive operation simultaneously that can carry out in the frequency range of being concerned about known in the art, this is covered by in the spirit and scope of the present invention.
The sharp resonance (sharpresonance) in the described driver is avoided in the Machine Design of described driver.In one embodiment of the invention, mechanical parameter (for example, Xiang Guan length and diameter and prestressed size) is chosen to make the resonance under the frequency of being concerned about relative flat and wide.In another embodiment, described thermo-mechanical drive little to or be rigid enough to and make the resonance of sound be higher than driving frequency.
The source of ultrasonic energy 99 of ultrasonic medical equipment 11 of the present invention is broad band ultrasonic energy sources.The described source of ultrasonic energy of ultrasonic medical equipment of the present invention is the electricity irritation source to described driver, and source of ultrasonic energy itself does not resonate.The described source of ultrasonic energy of ultrasonic medical equipment of the present invention can be handled the wide bandwidth of electromechanical actuators.Described bandwidth refers to the resonance width at half place of resonance peak power.For example, if describedly drive ultrasonic medical equipment and driving frequency is adjusted into half that obtains peak power with resonant frequency, this just is called half-band width and Here it is how half-band width defines so.
Fig. 5 shows ultrasonic probe 15 of the present invention, and described ultrasonic probe 15 is communicated with the intrasystem biomaterial of body vessels, has manifested a plurality of horizontal nodes 40 and a plurality of horizontal antinodal points 42 simultaneously.In Fig. 5, ultrasonic probe 15 is along with the crooked route of vascular system and with the bending transmission of ultrasonic energy along vascular system.After described bending before the described bending in vascular system, in vascular system and the described bending in vascular system, a plurality of antinodal points 42 are along the longitudinal axis location of ultrasonic probe 15.Frequency conversion drive of the present invention changes driving frequency to guarantee the length transmission of ultrasonic energy part after comprising of probe is crooked, with ablating biological material 16.As previously discussed, the crooked route of vascular system brings the resonance ultrasonic system a plurality of problems, and wherein, ultrasonic probe can not be delivered to biomaterial with enough ultrasonic energies.
Fig. 8 A and Fig. 8 B show under the situation of the operation frequency that changes ultrasonic probe 15, provide competent ultrasonic energy delivery with ablating biological material 16.In many cases, ultrasonic probe 15 can not be moved to more favourable position.Fig. 8 A and Fig. 8 B show at a plurality of location bending ultrasonic probes 15 with respect to the effect with two kinds of different frequency excitation ultrasonic probes 15.
Fig. 8 A and Fig. 8 B show along with bending position 24 changes from near-end 31 to far-end, in the time of in crooked in probe is placed on vascular system, along the distribute power of the active section of ultrasonic probe 15.The power of active section from the crest 104 of representing ceiling capacity to the trough 107 of representing least energy.Notice that the crest 104 of the power of curved shape and trough 107 are different from horizontal node 40 and horizontal antinodal points 42.The bending position 106 that illustrates has provided the effect that changes the operation frequency of ultrasonic probe 15.Crest 104 representative is along the zone of the longitudinal axis of ultrasonic probe 15, and in these zones, ultrasonic probe 15 can be crooked significantly and still produces significant power.If trough 107 representative ultrasonic probes 15 are crooked significantly then zone that power descends significantly.Shown in Fig. 8 A, concerning operation ultrasonic probe 15 under example frequency 21kHz, bending position 106 matches with the minimum power at trough 107 places.By operation frequency being changed to other example frequency 23kHz, identical bending position 106 matches substantially with the peak power shown in Fig. 8 B.Change described frequency and also just changed distance between the adjacent trough 107 or the distance between the adjacent peaks 104.For example, in Fig. 8 A, example frequency 21kHz makes distance or the distance between the adjacent peaks 104 between the adjacent trough 107 be about 12 centimetres.In Fig. 8 B, example frequency 23kHz makes distance or the distance between the adjacent peaks 104 between the adjacent trough 107 be about 11 centimetres.
Ultrasonic probe 15 is placed to biomaterial 16 and is communicated with, and the excitation ultrasound energy source 99 then.By the Nonlinear Dynamic bending of ultrasonic probe 15, described horn has produced along the lateral wave of the part longitudinal axis of ultrasonic probe 15 at least.Along with lateral wave is propagated along the longitudinal axis of ultrasonic probe 15, produced horizontal supersonic vibration along the longitudinal axis of ultrasonic probe 15.Ultrasonic probe 15 vibrates with lateral vibration mode.The described lateral vibration mode of ultrasonic probe 15 is different with axially (or the vertically) vibration mode disclosed in the prior art.Described horizontal supersonic vibration along the longitudinal axis of ultrasonic probe 15 has produced along a plurality of horizontal node and a plurality of horizontal antinodal points of the part longitudinal axis of ultrasonic probe 15.
Fig. 4 shows the ultrasonic probe of the present invention 15 that has a plurality of horizontal nodes 40 and a plurality of horizontal antinodal points 42 along the part longitudinal axis of ultrasonic probe 15.Laterally node 40 is least energy and minimum vibration zone.Horizontal antinodal points 42, promptly ceiling capacity and maximum vibration zone occur in along the place, recurrence interval of the described part longitudinal axis of ultrasonic probe 15.The spacing of the horizontal node 40 of ultrasonic probe 15 and the quantity of horizontal antinodal points 42 and described horizontal node 40 and described horizontal antinodal points 42 depends on the frequency of the energy that is produced by source of ultrasonic energy 99.Laterally the interval (separation) of node 40 and horizontal antinodal points 42 is functions of frequency, and can influence described interval by regulating (tune) ultrasonic probe 15.When suitably regulating ultrasonic probe 15, can find half place of the distance of horizontal antinodal points 42 between described horizontal node 40, described horizontal node 40 is adjacent to each side of described horizontal antinodal points 42.
Described lateral wave is propagated along the longitudinal axis of ultrasonic probe 15, and the interaction between the medium around the surface of ultrasonic probe 15 and the ultrasonic probe 15 produces sound wave in described surrounding medium.Along with described lateral wave is propagated along the longitudinal axis of ultrasonic probe 15, ultrasonic probe 15 laterally vibrates.The described transverse movement of ultrasonic probe 15 produces hole (cavitation) with ablating biological material 16 in the medium around the ultrasonic probe 15.Cavitation is a kind of process, wherein form little hole in the medium around by the rapid movement of ultrasonic probe 15, and described hole then is forced to compression.The compression of described hole produces acoustic energy wave, and the substrate (matrix) of described acoustic energy wave dissolving (dissolve) pinning (bind) biomaterial 16 is simultaneously to the effect of health tissues not damaged.
Biomaterial 16 is decomposed into has the particle that size is equivalent to Red blood corpuscle (diameter is approximately 5 microns).The size of described particle makes particle easily discharge in human body by traditional method or dissolve simply and enters the blood flow.The traditional method of discharging described particle in the human body comprises described particle is sent to kidney by described blood flow that said particle is drained as the refuse of human body.
The described horizontal supersonic vibration of ultrasonic probe 15 causes the part longitudinal axis of ultrasonic probe 15 along the direction vibration that is not parallel to ultrasonic probe 15 longitudinal axis.The longitudinal axis that described oscillation crosswise causes ultrasonic probe 15 is moving substantially and on the perpendicular direction of the longitudinal axis of ultrasonic probe 15.U.S. Patent No. 6 the assignee, 551,337, No.6,652,547, No.6,660,013, No.6 has described the ultrasonic probe that is used for the oscillation crosswise that biomaterial melts in 695,781, described patent has also been described the application at the Vltrasonic device that is used to melt of the design parameter that is used for this ultrasonic probe and ultrasonic probe, thus all described patents by quote with and in this merging.
As the result of the described horizontal supersonic vibration of ultrasonic probe 15, the execution of the biomaterial 16 of ultrasonic medical equipment 11 is not limited to those zones that ultrasonic probe 15 can contact with biomaterial 16.More properly, when the part longitudinal axis of ultrasonic probe 15 is positioned near biomaterial 16, all and a plurality of strong (energetic) laterally in node 40 and a plurality of horizontal antinodal points 42 adjacent areas biomaterial 16 be removed, wherein said a plurality of strong horizontal node 40 and a plurality of horizontal antinodal points 42 produce along the partial-length of the longitudinal axis of ultrasonic probe 15, typically in the big region generating to about 6mm radius that has around ultrasonic probe 15.
Innovative point of the present invention is to utilize the ability of comparing the ultrasonic probe 15 with very small diameter with the prior art probe, because the shattering process of biomaterial does not rely on the zone of needle point 9, so inefficent loss.Therefore, the ultrasonic probe 15 of highly flexible can be designed to be easy to be inserted in the biomaterial zone or comprise in the extremely narrow space (interstice) of biomaterial.Another advantage that the present invention possessed is to make biomaterial 16 move away cylindricality or the interior big zone of tubular surface apace.
The frequency conversion drive of ultrasonic medical equipment 11 of the present invention is operable at every turn with a kind of frequency drives ultrasonic medical equipment 11.Along with the change of driving frequency, the ablation effect of ultrasonic probe 15 is also changed.The described ultrasonic probe of ultrasonic medical equipment of the present invention comprises many lateral vibration modes.For example, for having the about 0.018 inch ultrasonic probe of about 135 centimetres of length, diameter, the longitudinal resonance of ultrasonic probe 15 takes place in every approximately 1500Hz.The lateral resonance of ultrasonic probe 15 takes place to 140Hz in about every 200Hz.Therefore, owing to changed described driving frequency, change frequency to find lateral resonance than finding that longitudinal resonance is easy.
In one embodiment of the invention, described frequency conversion drive of the present invention is that open loop drives (openloop drive), and described open loop drives the frequency that allows on the described transducer and changes continuously, and does not need to know from ultrasonic probe 15 what returns.In described open loop drives structure, frequency changes in known useful scope, and does not need feedback.Described operational frequency range is scheduled to by manufacturing tolerance and specification, thereby each transducer will be operated under same scope.Source of ultrasonic energy 99 can be at the frequency conversion drive sequencing, and without any need for feedback.In the present embodiment, described probe is operated between the frequency that biomaterial melts, but other the time, described probe is operated between the frequency that biomaterial does not melt.In the present embodiment, source of ultrasonic energy 99 is not carried out pre-operation scanning.
By being similar to the example shown in Fig. 8 A and Fig. 8 B, the described open loop that can come structurally to understand the frequency conversion operation of ultrasonic medical equipment 11 best drives the functional characteristics of structure.Suppose 21kHz drive on ultrasonic probe 15, produce about 10.5 cycles conoscope image (just, laterally node and laterally the antinodal points figure with about 10.5 centimetres separately), 23kHz drives and producing the conoscope image in about 11.5 cycles on the ultrasonic probe 15 and the driving of 25kHz produces the conoscope image in about 12.5 cycles on ultrasonic probe 15, then the particular curve shape of ultrasonic probe 15 will influence the horizontal supersonic vibration of ultrasonic probe 15 and the ablation effect of biomaterial.For example, under a certain application scenario, can infer ultrasonic probe 15 with special mode bending so that ultrasonic probe 15 under described 21kHz operation frequency, do not produce be used for the ablating biological material and along the horizontal supersonic vibration of this bending propagate ultrasonic energy.Yet, under described 23kHz and 25kHz operation frequency, ultrasonic probe 15 produce be used for the ablating biological material and along the horizontal supersonic vibration of this bending propagate ultrasonic energy.In the described open loop drives structure of the frequency conversion drive of the ultrasonic medical equipment 11 of this structure, described operation frequency is modulated lentamente in the scope of about 20kHz between about 26kHz, and 2/3rds time produces the described horizontal supersonic vibration and the biomaterial ablation effect of described ultrasonic probe thus.On the contrary, the prior art resonator system is only operated under a frequency, and does not produce the biomaterial execution of described ultrasonic probe.
In another embodiment of the present invention, for frequency shift to taking place under the frequency that biomaterial melts, the frequency conversion drive of ultrasonic medical equipment 11 of the present invention is operated under the closed loop that obtains from the real-time feedback of ultrasonic probe 15.In this embodiment of the present invention, loop is closed, and various parameters have been searched for, these parameters include, but is not limited to drive signal with respect to the variation of the relative phase of feedback signal, this phase relation ratio with respect to drive frequency variations, and described various parameters help source of ultrasonic energy 99 decisions to scan (sweep) under which frequency.
In one embodiment of the invention, ultrasonic medical equipment 11 of the present invention is searched for the frequency that biomaterial 16 melts generation by the phase angle of search inverse signal.No matter whether drive is resonance, the remainder of ultrasonic probe 15 and ultrasonic medical equipment 11 has resonance really, and described resonance is based on from the feedback of the current/voltage of described driver or detects from the feedback of the separate microphone element of ultrasonic medical equipment 11.
In another embodiment of the present invention, ultrasonic medical equipment 11 of the present invention is searched for the frequency that biomaterial 16 melts generation by detecting hole based on the broadband random noise that produces.In this embodiment of the present invention, comprise that the other transducer of mike is used to pick up the echo of ultrasonic probe 15.When cavitation takes place, produce stochastic signal to help to discern the frequency that biomaterial 16 melts.In when, with lateral vibration mode operation taking place when, the different frequency that also has many excitations simultaneously to come out.Operation with lateral vibration mode has produced the particular noise of picking up by mike.
The described frequency conversion drive of ultrasonic medical equipment of the present invention be operable to the vertical direction of the described longitudinal axis on the vibration ultrasonic probe 15.When making ultrasonic probe 15 deflections along bending, because described frequency conversion drive can be carried out operation in the certain frequency scope, so described frequency conversion drive has improved the ablation effect of ultrasonic probe 15.Because therefore lateral vibration mode has increased the probability of operation ultrasonic probe 15 under the lateral operation pattern more than longitudinal vibration mode in given frequency range.
Fig. 6 is the block diagram of the preferred embodiments of the present invention, and wherein the system 111 of ultrasonic medical equipment 11 uses the phase analysis feedback.System 111 powers by exchanging (AC) power supply (not shown).Central processing unit (CPU) 124 pre-programmed are to produce signal, and described signal is set the frequency and the amplitude of ultrasound drive signals based on the feedback that obtains from other functional device of system 111.Number-Mo transducer (DAC) 130 produces analogue signal under the control of CPU124, the amplitude of the output frequency of this analogue signal setting voltage control generator (VCO) 128 and the driving signal that produced by power amplifier 138.Described driving signal is being sent into transducer assemblies with before producing the Supra-voice sound energy, and by isolation barrier 146 electrical isolation, wherein said transducer assemblies comprises power changing device 140 and inductive transducer (sensetransducer) 142 and ultrasonic probe 15.Inductive transducer 142 is used to described system that feedback is provided.Output signal from inductive transducer 142 must be isolated by isolation barrier 146 before being used by described system.
According to following formula, phase detector 134 is used for the phase place of the output voltage of the phase place of output voltage of comparison power amplifier 138 and inductive transducer 142:
F
in=|F
in|(cos(ω
0t+φ
1))
F
out=|F
out|(cos(ω
0t+φ
2))
Wherein:
F
InBe input function (just, voltage drives);
F
OutBe output function (inductive transducer voltage just);
T is a transformation period independently;
φ is the phase place that records;
ω
0It is driving frequency.
The output of phase detector 134 is by mould-number transducer (ADC) 126 digitizeds and send into CPU 124.Feedback path is used for judging at ultrasonic probe 15 (part of transducer assemblies 140) goes up the frequency that various that want and undesired resonance take place.Phase contrast between the voltage signal that drives voltage of signals and return from the inductive transducer element can be used to locate the operation frequency that ultrasonic probe 15 can be carried out useful work.Along with of the frequency band interscan of described operation frequency, will on ultrasonic probe 15, will cause various mechanical resonances in permission.
According to following formula, longitudinal resonance occurs on the ultrasonic probe 15.
Wherein:
Δ f is the frequency interval between the longitudinal resonance;
C is the vertical velocity of wave in medium;
L is the length of ultrasonic probe.
For 135 centimetres of length, by the ultrasonic probe 15 that titanium constitutes, this equals the longitudinal resonance of every approximately 1800Hz.
According to following formula, lateral resonance betides on the ultrasonic probe 15:
Wherein:
f
nIt is the frequency of n transverse mode;
K is the radius of gyration (to circle cross-section is d/4, and wherein d is the diameter of ultrasonic probe) of cross section;
C is the vertical velocity of wave in medium;
L is the length of ultrasonic probe;
Thereby the frequency interval around any frequency can be judged by above-mentioned formula by getting two differences between the continuous mode.For 135 centimetres of length, by the ultrasonic probe 15 that titanium constitutes, this equals the lateral resonance of every 140Hz under 10kHz.Because the existence of these longitudinal resonances and lateral resonance, the phase relation between described driving signal and the described inverse signal (drive current or microphone element voltage) is interfered.Longitudinal resonance causes big interference in described phase place, oscillation crosswise causes little interference in described phase place.Following formula has been described decision rules:
Vertical pattern
Transverse mode
Wherein, M is the slowest rate of change of the vertical pattern of experience judgement, and N is the fastest rate of change of the transverse mode of experience judgement.
When frequency scanning, by phase place is shone upon with respect to frequency, the frequency that may carry out useful work can be determined and be energized one given period before moving to different frequencies.Also have, ultrasonic medical equipment 11 can be determined by the phase jitter (jitter) that quantizes to occur the signal that returns from inductive transducer 142 in the effect under the given driving frequency.Even when ultrasonic probe 15 is energized with single-frequency, the motion of the ultrasonic probe 15 that is caused will cause multiple other frequency, and therefore causes the phase jitter that will come across from the signal that inductive transducer 142 returns.In research and development of products, the phase jitter of operation probe (for example: the various power efficiencies of passing to the target area) is quantized in all cases.This information is programmed in the CPU memorizer.In when operation, the frequency of power transmission is adjusted into various frequencies in the frequency band that allows.Under each operation frequency, analyze the signal that returns from described sensing element of transducer, quantize beating of described signal.Result based on the comparison for the particular frequencies of using, can decision making.Following formula has been described decision principle:
E wherein
DBe that the minimum phase that experience is judged is beated, this minimum phase is beated relevant with effective power transmission under the specified driving voltage D.
Carry out useful work if judge this frequency, then before this power moved to different frequencies, this frequency can be used for giving ultrasonic probe 15 with useful energy delivery in preset time in the section.Can not carry out useful work if judge this frequency, then described system can move to immediately and carry out test operation under the different frequency and under described different frequency.
Fig. 7 is the block diagram of another embodiment of the present invention, and the system 191 of wherein said ultrasonic medical equipment uses the Spectrum Analysis feedback.Described system is by exchanging the power supply of (AC) power supply (not shown).CPU (CPU) 154 pre-programmed are to produce signal, and described signal is set the frequency and the amplitude of ultrasound drive signals based on resulting feedback from other functional device of described system.Number-Mo transducer (DAC) 160 produces analogue signal under the control of CPU154, the output frequency of this analogue signal setting voltage control generator 158 and the driving signal amplitude that is produced by power amplifier (VCO) 168.Described driving signal be fed to transducer assemblies with before producing the Supra-voice sound energy by isolation barrier 176 electrical isolation, this transducer assemblies comprises power changing device 170 and reads transducer 172 and ultrasonic probe 15.Inductive transducer 172 is used to described system that feedback is provided.Output signal from inductive transducer 172 is used before and must be isolated by isolation barrier 176 by described system.Described signal is by mould-number transducer (ADC) 178 digitizeds and pass to Spectrum Analysis device 180.Spectrum Analysis device 180 will offer CPU 154 about the information of the output signal frequency wave spectrum of inductive transducer, and this information makes CPU 154 judge the effects of described system under current driving signal frequency.Based on this feedback, CPU154 will be with the described transducer assemblies of current frequency drives, perhaps moves under the different frequencies and judges the effect of described system under new frequency.Inductive transducer 172 in described equipment produce comprise relate to ultrasonic probe 15 performances information in interior output signal.Even when ultrasonic probe 15 is energized with single-frequency, the motion of the ultrasonic probe 15 that is caused also can cause various other frequencies that will appear in the ultrasonic probe 15.In research and development of products, collected the wave spectrum (for example, the various efficient that pass to the power of target area) of operation probe under multiple situation.The wave spectrum that is associated with optimal performance (or key character of wave spectrum) is stored in the memorizer of CPU 154.In operation, the frequency of power transmission is adjusted to various frequencies in the frequency band that allows.Under every kind of operation frequency, analyze the signal that returns from inductive transducer element 172, and the wave spectrum (or key character of wave spectrum) of this signal is compared with the probe wave spectrum of collecting previously.Based on correlated result, can decision making for the particular frequencies of using.Carry out useful work if judge this frequency, then before this frequency shifts arrived different frequencies, this frequency can be used for giving ultrasonic probe 15 with useful energy delivery in preset time in the section.Can not carry out useful work if judge this frequency, then described system can move to immediately and carry out test operation under the different frequency and under described different frequency.
For feedback being offered CPU124,154, power meter 36,66 can also be arranged in described system by mould-number transducer (ADC) 126,156.The described feedback that obtains from power meter 36,66 can be used to avoid can not provide cost under the frequency of energy to drive the operating time of described system to ultrasonic probe at those described transducers.In order to control the power transmission more accurately, described feedback can also allow to adjust the amplitude of described driving signal.Power meter 36,66 is operated according to following formula:
Mean power,
Wherein:
T
0It is any regular time;
Driving voltage, V=Acos (ω
0T+ φ);
Drive current, I=Bcos (ω
0T+ φ).
Power meter 36,66 can not help the fine setting of frequency, and described power meter only is the bigness scale as the power that is transmitted.Described power meter can not be in available power and is not done between the power of useful work and distinguish.
In one embodiment of this invention, described system has used the phase analysis feedback sources.Phase contrast 148 between described driving voltage of signals and the electric current, rather than the phase contrast between described driving voltage of signals and the voltage signal that returns from described inductive transducer element, can be used to locate the operation frequency that flexible stylet can be carried out useful work.
Close loop maneuver can be scanning closed loop (scan closed loop)/operation open loop (run open loop) or operation closed loop (run closed loop).This close loop maneuver of two types is similar.In one embodiment of this invention, the close loop maneuver pattern is scanning closed loop/operation open loop, and two kinds of different operational circumstances are wherein arranged: scanning and transmission energy.In another embodiment of the present invention, the close loop maneuver pattern is the operation closed loop, and wherein useful energy delivery is to flexible stylet, and carries out frequency analysis simultaneously.Those skilled in the art will recognize that other close loop maneuver known in the art also is covered by in the spirit and scope of the present invention.
In one embodiment of this invention, described open loop operator scheme has the driving frequency that slowly changes (modulation) in the frequency band that allows.Described frequency modulation(PFM) is the prescribed function (just, sinusoidal) of time, and the modulation signal band is limited to littler than about 100Hz.
In one embodiment of this invention, excitation when existing under the multiple frequency: in order to make to the maximization of target area energy delivered, plurality of V CO can be used for side by side driving described power changing device under some frequencies.
In an alternative embodiment of the present invention, ultrasonic probe 15 is vibrated with torsional mode.Under the torsional mode of described vibration, the part of the longitudinal axis of ultrasonic probe 15 is made of radially asymmetric cross section, and the length of ultrasonic probe 15 is chosen at the torsional mode low-resonance.Under the torsional mode of described vibration, transducer will be passed to ultrasonic probe 15 from the ultrasonic energy that source of ultrasonic energy 99 receives, thereby cause that ultrasonic probe 15 vibrates with reversing.Source of ultrasonic energy 99 produces electric energy, and this electric energy is used for producing twisting vibration along the longitudinal axis of ultrasonic probe 15.Described twisting vibration is torsional oscillation (torsionaloscillation).Thus, along the vibration back and forth in of comprising of ultrasonic probe 15 of equidistant points probe pinpoint 9, the longitudinal axis with respect to the short arc of ultrasonic probe 15 longitudinal axis.With the approaching part of a plurality of each node that reverses node (torsional node) and with a plurality of each node that reverses node away from the part out-of-phase vibration, described approaching part is vibrated clockwise simultaneously, and described away from Partial Inverse hour hands vibrations, vice versa.Described twisting vibration causes transmitting ultrasonic energy with minimum ultrasonic energy losses to biomaterial, and the loss of wherein said ultrasonic energy can limit the efficient of ultrasonic medical equipment 11.Described twisting vibration produces the rotation and the despining of the longitudinal axis that is following ultrasonic probe 15, described rotation and despining produce a plurality of node and a plurality of antinodal points that reverse of reversing along the part longitudinal axis of ultrasonic probe 15, described node and antinodal points cause along the hole of the part longitudinal axis of ultrasonic probe 15, and ultrasonic probe 15 comprises being arranged in around the radially asymmetric cross section of the medium of ultrasonic probe 15 of ablating biological material.Be used for being described in assignee's the U.S. Patent application No.10/774 that subjects to approval with the apparatus and method of the ultrasonic medical equipment of torsional mode operation, 985, therefore whole this application is by quoting in this merging.
In another embodiment of the present invention, ultrasonic probe 15 is with torsional mode and transverse mode vibration.Transducer will pass to ultrasonic probe 15 from the ultrasonic energy of source of ultrasonic energy 99, so that ultrasonic probe 15 produces twisting vibration.Described twisting vibration comprises that along the oscillation crosswise of ultrasonic probe active section described oscillation crosswise produces a plurality of nodes and a plurality of antinodal points along described active section, and described a plurality of nodes and described a plurality of antinodal points are producing hole in the medium of ultrasonic probe.The described active section of ultrasonic probe 15 not only experiences described twisting vibration but also experience described oscillation crosswise.
Depend on the physical characteristic (just, length, diameter etc.) and the material behavior (just, yield strength, modulus etc.) of ultrasonic probe 15, encourage described oscillation crosswise by described twisting vibration.Because the shear component of common elastic force is so the coupling of described twisting vibration and described oscillation crosswise is possible.When the frequency of described transducer during near the lateral resonance frequency of ultrasonic probe 15, described oscillation crosswise just is introduced into.Concerning every kind of torsional mode, because multiple approaching lateral vibration mode is arranged, so the combination of vibration of described torsional mode and the vibration of described transverse mode is possible.By ultrasonic probe 15 is applied tension force, for example by bending ultrasonic probe 15, described oscillation crosswise just is adjusted into consistent with described twisting vibration.Because tensile change, bending will cause the drift (shift) of frequency.Under described torsional vibration mode and described lateral vibration mode, the described active section of ultrasonic probe 15 is along vibrating with the uneven direction of the longitudinal axis of ultrasonic probe 15, and the equidistant points along ultrasonic probe 15 longitudinal axis vibrates in respect to the short arc of ultrasonic probe 15 longitudinal axis back and forth simultaneously.The apparatus and method of the ultrasonic medical equipment of operating under transverse mode and torsional mode are described in assignee's the U.S. Patent application No.10/774 that subjects to approval, and 898, therefore whole this application is by quoting in this merging.
The document of all patents, patent application and the publication of quoting here is by quoting in this whole merging.Although the present invention illustrates especially and describes the present invention by the reference preferred embodiment, but it will be understood by those skilled in the art that, in the scope that does not break away from appending claims of the present invention and defined, can carry out various modification in form and details.