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WO2006041481A1 - Appareil et procede pour dispositif medical a ultrasons utilise pour traiter une maladie arterielle peripherique - Google Patents

Appareil et procede pour dispositif medical a ultrasons utilise pour traiter une maladie arterielle peripherique Download PDF

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Publication number
WO2006041481A1
WO2006041481A1 PCT/US2004/032991 US2004032991W WO2006041481A1 WO 2006041481 A1 WO2006041481 A1 WO 2006041481A1 US 2004032991 W US2004032991 W US 2004032991W WO 2006041481 A1 WO2006041481 A1 WO 2006041481A1
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WIPO (PCT)
Prior art keywords
ultrasonic
ultrasonic probe
transverse
occlusional
deposit
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2004/032991
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English (en)
Inventor
Robert A. Rabiner
Bradley A. Hare
Craig T. Kelley
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Omnisonics Medical Technologies Inc
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Omnisonics Medical Technologies Inc
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Publication date
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Priority to PCT/US2004/032991 priority Critical patent/WO2006041481A1/fr
Publication of WO2006041481A1 publication Critical patent/WO2006041481A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22014—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
    • A61B2017/22015—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member

Definitions

  • the present invention relates to medical devices, and more importantly to an apparatus and a method for an ultrasonic medical device to treat peripheral artery disease.
  • Peripheral artery disease affects approximately twelve million adults in the United States. The incidence of peripheral artery disease is increased for people over the age of seventy, with approximately twenty percent of Americans over seventy affected with peripheral artery disease. By contrast, less than eight percent of Americans under age seventy are affected by peripheral artery disease. Peripheral artery disease increases the risk of heart attack, stroke, amputation of lower extremity limbs and, in some cases, death.
  • Peripheral artery disease is a form of atherosclerosis in which occlusional deposits build up along the artery walls and reduce blood circulation. Tissues throughout the body, which receive blood from the arteries, need oxygen from the blood that is delivered through the arteries. The buildup of the occlusional deposits along the artery walls reduces the cross sectional area through which the blood flows, therefore depriving the tissues of oxygen and increasing the potential of damage to the tissues. The arteries lose elasticity and are unable to dilate to allow for greater blood flow when needed.
  • Peripheral artery disease occurs in the hundreds of arteries outside of the heart, better known as the peripheral arteries. The most common location for peripheral artery disease is in the peripheral arteries in the legs and feet. Within the legs, the most common location of peripheral artery disease is in the iliac, femoral and popliteal arteries. Peripheral artery disease also occurs in the arms and there has been a low frequency of peripheral artery disease in the heart and the brain. In the early stages of peripheral artery disease in the leg, cramping or fatigue in the legs, calves and buttocks occurs during activity, leading to a type of pain known as claudication. Despite oxygen reaching the muscles during a rest period, a pain cycle known as intermittent claudication often provides the first warning sign of peripheral artery disease.
  • Peripheral artery disease of the mesenteric arteries also known as the intestinal arteries, leads to mesenteric arterial disease.
  • Mesenteric arterial disease is less common but can cause severe pain, weight loss and even death from intestinal gangrene.
  • Prior art methods of treating peripheral artery disease are invasive, increase the probability of future problems and offer temporary relief mechanisms that do not effectively treat the cause of the peripheral artery disease.
  • Pharmacological agents can be used to enlarge or dilate the affected artery, but pharmacological agents often produce harmful health side effects.
  • a balloon angioplasty can be performed in an attempt to open an artery, but a balloon angioplasty places high stresses on the vasculature that may compromise the integrity of the vasculature.
  • Surgical procedures including removal of the lining of the artery (endarterectomy) or repair or replacement of the vessel (grafting) are invasive procedures that subject the patient to risks and trauma.
  • U.S. Patent No. 6,522,929 to Swing discloses a treatment of peripheral vascular disease using an electrical stimulator and acupuncture needles.
  • a plurality of the Swing acupuncture needles are placed at specific acupuncture points and a current is passed through the acupuncture needles.
  • the application of the current to the blood vessels with the Swing device increases the blood flow to the vessels, allowing more oxygen and body nutrients to treat the peripheral vascular disease.
  • the Swing device causes a stinging pain and trauma to the patient.
  • the Swing device does not directly treat the occlusive deposits causing the peripheral vascular disease.
  • U.S. Patent No. 5,231,080 to Scholkens discloses a method for treatment of peripheral vessel disease by administration of angiotensin converting enzyme inhibitors.
  • Scholkens discloses administration of angiotensin converting enzyme inhibitors to prevent platelet aggregation.
  • the Scholkens inhibitor does not remove the occlusional deposits comprising the peripheral vessel disease, but rather comprises administration of an inhibitor to prevent platelet aggregation.
  • the prior art does not provide a solution for effectively preventing and treating peripheral artery disease.
  • the prior art does not remove the occlusions or deposits comprising the peripheral artery disease and the prior art presents adverse consequences to the patient. Therefore, there remains a need in the art for an apparatus and a method of preventing and treating peripheral artery disease that effectively removes the occlusional deposits in a safe, effective and time efficient manner.
  • the present invention is an ultrasonic medical device for resolving peripheral artery disease comprising: an ultrasonic probe having a proximal end, a distal end and a longitudinal axis between the proximal end and the distal end; a transducer creating a transverse ultrasonic vibration along at least a portion of the longitudinal axis of the ultrasonic probe; a coupling engaging the proximal end of the ultrasonic probe to a distal end of the transducer; and an ultrasonic energy source engaged to the transducer that produces an ultrasonic energy.
  • the transverse ultrasonic vibration produces a plurality of transverse nodes and a plurality of transverse anti-nodes along at least a portion of the longitudinal axis of the ultrasonic probe to ablate an occlusional deposit causing peripheral artery disease.
  • the present invention is an ultrasonic medical device for treating peripheral artery disease.
  • the ultrasonic medical device includes an ultrasonic probe having a proximal end, a distal end terminating in a probe tip and a longitudinal axis between the proximal end and the distal end.
  • the ultrasonic medical device also includes a transducer that converts electrical energy into mechanical energy, creating a transverse ultrasonic vibration along the longitudinal axis of the ultrasonic probe, and a coupling engaging the proximal end of the ultrasonic probe and a distal end of the transducer.
  • the transverse ultrasonic vibration generates a plurality of transverse nodes and a plurality of transverse anti-nodes along at least a portion of the longitudinal axis of the ultrasonic probe, creating cavitation in a medium surrounding the ultrasonic probe to ablate an occlusional deposit and treat peripheral artery disease.
  • the present invention is a method of treating peripheral artery disease.
  • An ultrasonic medical device comprising an ultrasonic probe having a proximal end, a distal end terminating in a probe tip and a longitudinal axis between the proximal end and the distal end is provided.
  • the ultrasonic probe is inserted into a vasculature and moved adjacent to an occlusional deposit in a peripheral artery.
  • the ultrasonic probe is placed in communication with the occlusional deposit and an ultrasonic energy source engaged to the ultrasonic probe is activated to generate a transverse ultrasonic vibration along at least a portion of the longitudinal axis of the ultrasonic probe.
  • the transverse ultrasonic vibration creates a plurality of transverse anti-nodes along a portion of the longitudinal axis of the ultrasonic probe.
  • the present invention is a method of ablating an occlusional deposit to treat peripheral artery disease comprising: providing an ultrasonic medical device comprising an ultrasonic probe having a proximal end, a distal end and a longitudinal axis between the proximal end and the distal end; inserting the ultrasonic probe into a femoral artery; moving the ultrasonic probe into a peripheral artery; placing the ultrasonic probe in communication with an occlusional deposit in the peripheral artery; and activating an ultrasonic energy source engaged to the ultrasonic probe to produce an electric signal that drives a transducer of the ultrasonic medical device to produce a transverse ultrasonic vibration of the ultrasonic probe, wherein the transverse ultrasonic vibration produces cavitation in a medium surrounding the ultrasonic probe to ablate the occlusional deposit.
  • the present invention provides an apparatus and a method for an ultrasonic medical device to treat peripheral artery disease.
  • An ultrasonic probe is placed in communication with an occlusional deposit causing peripheral artery disease and a transverse ultrasonic vibration along at least a portion of the longitudinal axis of the ultrasonic probe ablates the occlusional deposit.
  • the present invention provides an ultrasonic medical device for treating peripheral artery disease that is simple, user-friendly, time efficient, reliable and cost effective.
  • FIG. 1 is a side plan view of an ultrasonic probe of the present invention inserted contralaterally into an external iliac artery of a lower limb of a patient.
  • FIG. 2 is a side plan view of an ultrasonic probe of the present invention inserted contralaterally into a superficial femoral artery of a lower limb of a patient.
  • FIG. 3 is a side plan view of an ultrasonic probe of the present invention inserted ipsilaterally into an artery of a lower limb of a patient.
  • FIG. 4 is a side plan view of an ultrasonic medical device of the present invention capable of ablating an occlusional deposit to treat peripheral artery disease.
  • FIG. 5 is a side plan view of an ultrasonic probe of the present invention having an approximately uniform diameter from a proximal end of the ultrasonic probe to the distal end of the ultrasonic probe.
  • FIG. 6 shows a side plan view of an ultrasonic probe of the present invention showing a plurality of transverse nodes and a plurality of transverse anti-nodes along a portion of a longitudinal axis of the ultrasonic probe.
  • FIG. 7 is a view of a leg of a patient showing a plurality of peripheral arteries with an occlusional deposit in an external iliac artery of a leg.
  • FIG. 8 is an enlarged view of a portion of an ultrasonic probe of the present invention inserted into an external iliac artery and being moved toward an occlusional deposit in the external iliac artery of a leg.
  • FIG. 9 is an enlarged view of an ultrasonic probe of the present invention in communication with an occlusional deposit in an external iliac artery of a leg.
  • FIG. 10 is an enlarged view of an ultrasonic probe of the present invention showing a plurality of transverse anti-nodes in communication with an occlusional deposit in an external iliac artery of a leg.
  • FIG. 11 is an enlarged view of an ultrasonic probe in communication with a partially ablated occlusional deposit in an external iliac artery.
  • FIG. 12 is an enlarged view of an external iliac artery after ablation of an occlusional deposit using an ultrasonic probe of the present invention.
  • the present invention provides an apparatus and a method for using an ultrasonic medical device to treat peripheral artery disease.
  • the ultrasonic medical device comprises an ultrasonic probe having a proximal end, a distal end and a longitudinal axis therebetween, a transducer creating a transverse ultrasonic vibration along at least a portion of the longitudinal axis of the ultrasonic probe, a coupling engaging the proximal end of the ultrasonic probe to a distal end of the transducer and an ultrasonic energy source engaged to the transducer that produces an ultrasonic energy.
  • the transverse ultrasonic vibration generates a plurality of transverse nodes and a plurality of transverse anti-nodes along at least a portion of the longitudinal axis of the ultrasonic probe, creating cavitation in a medium surrounding the ultrasonic probe to ablate an occlusional deposit and treat peripheral artery disease.
  • the ultrasonic medical device of the present invention can also be used to treat peripheral vascular disease, including arterial or venous disease.
  • peripheral vascular disease including arterial or venous disease.
  • Atheroma fatty deposits in the intima of the vasculature, do not generally occur on the venous side where the usual problem is thrombosis arising from an inability to get the blood back to the lungs (i.e., venous valve damage, external trauma, stenosis).
  • the occlusional deposit or thrombus results from damage to the vasculature by the atheroma or by narrowing of the vessel as the atheroma builds up.
  • the ultrasonic medical device of the present invention may be used to treat peripheral artery disease, peripheral vascular disease and other arterial or venous diseases.
  • “Ablate” as used herein refers to removing, clearing, destroying or taking away an occlusional deposit.
  • “Ablation” as used herein refers to a removal, clearance, destruction, or taking away of the occlusional deposit.
  • Anti-node refers to a region of a maximum energy emitted by an ultrasonic probe at or adjacent to a specific location along a longitudinal axis of the ultrasonic probe.
  • Node refers to a region of a minimum energy emitted by an ultrasonic probe at or adjacent to a specific location along a longitudinal axis of the ultrasonic probe.
  • Probe refers to a device capable of propagating an energy emitted by the ultrasonic energy source along a longitudinal axis of the probe, resolving the energy into an effective cavitational energy at a specific resonance (defined by a plurality of nodes and a plurality of anti-nodes along an "active area" of the probe).
  • Oxidational deposit refers to a collection of a matter including, but not limited to, a group of similar cells, intravascular blood clots, occlusions, thrombus, plaque, biological material, fibrin, calcified plaque, atheroma, calcium deposits, biological materials, atherosclerotic plaque, fatty deposits, adipose tissues, atherosclerotic cholesterol buildup, fibrous material buildup, arterial stenoses, minerals, high water content tissues, platelets, cellular debris, wastes and other occlusive materials.
  • Transverse refers to a vibration of a probe not parallel to a longitudinal axis of the probe.
  • a “transverse wave” as used herein is a wave propagated along the probe in which a direction of a disturbance at a plurality of points of a medium is not parallel to a wave vector.
  • Vasculature refers to the entire circulatory system for the blood supply including the venous system, the arterial system and the associated vessels, arteries, veins, capillaries, blood, and the heart.
  • the arterial system is the means by which blood with oxygen and nutrients is transported to tissues.
  • the venous system is the means by which blood with carbon dioxide and metabolic by-products is transported for excretion.
  • FIG. 1 shows the ultrasonic probe 15 inserted at an upper part of a leg 35 and adjacent to the occlusional deposit 55 in an external iliac artery 23.
  • the ultrasonic probe 15 is inserted into a leg 56 opposite the leg 35 having the occlusional deposit 55 for a contralateral approach.
  • a flexibility of the ultrasonic probe 15 allows the ultrasonic probe 15 to be navigated within the vasculature to the external iliac artery 23.
  • FIG. 2 shows the ultrasonic probe 15 inserted contralaterally in an upper part of the leg 56 and moved into the leg 35 adjacent to the occlusional deposit 55 in the superficial femoral artery 36 of the leg 35.
  • FIG. 3 shows an embodiment of the present invention in which the ultrasonic probe 15 is inserted ipsilaterally at an upper part of the leg ->5 to treat the occlusional deposit 55 in the superficial femoral artery 36 of the leg 56.
  • the ipsilateral approach shown in FIG. 3 inserts the ultrasonic probe 15 into the vasculature in a leg on the same side of the body as the occlusional deposit 55 to be treated.
  • FIG. 4 shows an ultrasonic medical device capable of ablating an occlusional deposit 55 to treat peripheral artery disease and prevent ischemia of tissues and muscles served by the peripheral arteries.
  • the ultrasonic probe 15 is used to ablate an occlusional deposit in the leg 35 of a patient.
  • the ultrasonic medical device 11 includes an ultrasonic probe 15 which is coupled to an ultrasonic energy source or generator 99 for the production of an ultrasonic energy.
  • a handle 88 comprising a proximal end 87 and a distal end 86, surrounds a transducer within the handle 88.
  • the transducer having a proximal end engaging the ultrasonic energy source 99 and a distal end coupled to a proximal end 31 of the ultrasonic probe 15, transmits the ultrasonic energy to the ultrasonic probe 15.
  • a connector 93 and a connecting wire 98 engage the ultrasonic energy source 99 to the transducer.
  • the ultrasonic probe 15 includes the proximal end 31, a distal end 24 that ends in a probe tip 9 and a longitudinal axis between the proximal end 31 and the distal end 24.
  • a diameter of the ultrasonic probe decreases from a first defined interval 26 to a second defined interval 28 along the longitudinal axis of the ultrasonic probe 15 over a transition 82.
  • a coupling 33 that engages the proximal end 31 of the ultrasonic probe 15 to the transducer within the handle 88 is illustrated generally in FIG. 4.
  • the coupling is a quick attachment-detachment system.
  • An ultrasonic medical device with a rapid attachment and detachment means is described in the Assignee's U.S. Patent No. 6,695,782 and Assignee's co-pending patent applications U.S. Serial No. 10/268,487 and U.S. Serial No. 10/268,843, which further describe the quick attachment-detachment system and the entirety of these patents and patent applications are hereby incorporated herein by reference.
  • FIG. 5 shows an embodiment of the ultrasonic probe 15 of the present invention where the diameter of the ultrasonic probe 15 is approximately uniform from the proximal end 31 of the ultrasonic probe 15 to the distal end 24 of the ultrasonic probe 15.
  • FIG. 6 shows a side plan view of an ultrasonic probe 15 of the present invention showing a plurality of transverse nodes 40 and a plurality of transverse anti-nodes 42 along a portion of a longitudinal axis of the ultrasonic probe 15.
  • the ultrasonic prooe ID is a wire
  • the ultrasonic probe 15 is elongated.
  • the diameter of the ultrasonic probe 15 changes at greater than two defined intervals.
  • the transitions 82 of the ultrasonic probe 15 are tapered to gradually change the diameter from the proximal end 31 to the distal end 24 along the longitudinal axis of the ultrasonic probe 15.
  • the transitions 82 of the ultrasonic probe 15 are stepwise to change the diameter from the proximal end 31 to the distal end 24 along the longitudinal axis of the ultrasonic probe 15.
  • the transitions can be of any shape known in the art and be within the spirit and scope of the present invention.
  • the gradual change of the diameter from the proximal end 31 to the distal end 24 occurs over the at least one transition 82, with each transition 82 having an approximately equal length. In another embodiment of the present invention, the gradual change of the diameter from the proximal end 31 to the distal end 24 occurs over a plurality of transitions 82 with each transition 82 having a varying length.
  • the transition 82 refers to a section where the diameter varies from a first diameter to a second diameter.
  • the ultrasonic probe 15 has a small diameter.
  • the cross section of the ultrasonic probe 15 is approximately circular.
  • the cross section of at least a portion of the ultrasonic probe 15 is non-circular.
  • the ultrasonic probe 15 comprising a wire having a non-circular cross section at the distal end can navigate through the vasculature.
  • the ultrasonic probe 15 comprising a flat wire is steerable in the vasculature.
  • a shape of the cross section of the ultrasonic probe 15 includes, but is not limited to, square, trapezoidal, oval, triangular, circular with a flat spot and similar cross sections. Those skilled in the art will recognize that other cross sectional geometric configurations known in the art would be within the spirit and scope of the present invention.
  • the diameter of the distal end 24 of the ultrasonic probe 15 is about 0.004 inches. In another embodiment of the present invention, the diameter of the distal end 24 of the ultrasonic probe 15 is about 0.015 inches. In other embodiments of the present invention, the diameter of the distal end 24 of the ultrasonic probe 15 varies between about 0.003 inches and about 0.025 inches. Those skilled in the art will recognize an ultrasonic probe 15 can have a diameter at the distal end 24 smaller than about 0.003 inches, larger than about 0.025 inches, and between about 0.003 inches and about 0.025 inches and be within the spirit and scope of the present invention.
  • the diameter of the proximal end 31 of the ultrasonic probe 15 is about 0.012 inches, hi another embodiment of the present invention, the diameter of the proximal end 31 of the ultrasonic probe 15 is about 0.025 inches, hi other embodiments of the present invention, the diameter of the proximal end 31 of the ultrasonic probe 15 varies between about 0.003 inches and about 0.025 inches.
  • the ultrasonic probe 15 can have a diameter at the proximal end 31 smaller than about 0.003 inches, larger than about 0.025 inches, and between about 0.003 inches and about 0.025 inches and be within the spirit and scope of the present invention.
  • the probe tip 9 can be any shape including, but not limited to, rounded, bent, a ball or larger shapes, hi a preferred embodiment of the present invention, the probe tip 9 is atraumatic and smooth to prevent damage to the peripheral arteries, hi one embodiment of the present invention, the ultrasonic energy source 99 is a physical part of the ultrasonic medical device 11. hi another embodiment of the present invention, the ultrasonic energy source 99 is not an integral part of the ultrasonic medical device 11.
  • the ultrasonic probe 15 is used to ablate the occlusional deposit 55 and may be disposed of after use.
  • the ultrasonic probe 15 is for a single use and on a single patient, hi a preferred embodiment of the present invention, the ultrasonic probe 15 is disposable, hi another embodiment of the present invention, the ultrasonic probe 15 can be used multiple times.
  • the ultrasonic probe 15 is designed, constructed and comprised of a material to not dampen the transverse ultrasonic vibration, and thereby supports a transverse vibration when flexed, hi a preferred embodiment of the present invention, the ultrasonic probe 15 comprises titanium or a titanium alloy. Titanium is a strong, flexible, low density, low radiopacity and easily fabricated metal that is used as a structural material. Titanium and its alloys have excellent corrosion resistance in many environments and have good elevated temperature properties, hi a preferred embodiment of the present invention, the ultrasonic probe 15 comprises titanium alloy Ti-6A1-4V.
  • the elements comprising Ti-6A1-4V and the representative elemental weight percentages of ⁇ -6A1-4V are titanium (about 90%), aluminum (about 6%), vanadium (about 4%), iron (maximum about 0.25%) and oxygen (maximum about 0.2%).
  • the ultrasonic probe 15 comprises stainless steel.
  • the ultrasonic probe 15 comprises an alloy of stainless steel.
  • the ultrasonic probe 15 comprises aluminum.
  • the ultrasonic probe 15 comprises an alloy of aluminum.
  • the ultrasonic probe 15 comprises a combination of titanium and stainless steel.
  • the ultrasonic probe 15 comprises a super-elastic alloy. Even when bent or stretched, the super-elastic alloy returns to its original shape when the stress is removed.
  • the ultrasonic probe 15 may comprise super-elastic alloys known in the art including, but not limited to, nickel-titanium super-elastic alloys and Nitinol.
  • Nitinol is a family of intermetallic materials, which contain a nearly equal mixture of nickel and titanium. Other elements can be added to adjust or tune the material properties. Nitinol is less stiff than titanium and is maneuverable in the vasculature. Nitonol has shape memory and super- elastic characteristics.
  • the shape memory effect describes the process of restoring the original shape of a plastically deformed sample by heating it. This is a result of a crystalline phase change known as thermoelastic martensitic transformation. Below the transformation temperature, Nitinol is martensitic. Nitinol's excellent corrosion resistance, biocompatibility, and unique mechanical properties make it well suited for medical devices. Those skilled in the art will recognize that the ultrasonic probe can be comprised of many other materials known in the art and be within the spirit and scope of the present invention.
  • the physical properties (i.e., length, cross sectional shape, dimensions, etc.) and material properties (i.e., yield strength, modulus, etc.) of the ultrasonic probe 15 are selected for operation of the ultrasonic probe 15 in the transverse mode.
  • the length of the ultrasonic probe 15 of the present invention is chosen to be resonant in a transverse mode.
  • the ultrasonic probe 15 is between about 30 centimeters and about 300 centimeters in length.
  • an ultrasonic probe can have a length shorter than about 30 centimeters, a length longer than about 300 centimeters and a length between about 30 centimeters and about 300 centimeters and be within the spirit and scope of the present invention.
  • the handle 88 surrounds the transducer located between the proximal end 31 of the ultrasonic probe 15 and the connector 93.
  • the transducer includes, but is not limited to, a horn, an electrode, an insulator, a backnut, a washer, a piezo microphone, and a piezo drive.
  • the transducer is capable of an acoustic impedance transformation of electrical energy provided by the ultrasonic energy source 99 to mechanical energy.
  • the transducer sets the operating frequency of the ultrasonic medical devic* 11.
  • the transducer is capable of engaging the ultrasonic probe 15 at the proximal end 31 with sufficient restraint to form an acoustical mass that can propagate the ultrasonic energy provided by the ultrasonic energy source 99.
  • FIG. 7 shows a partial anatomy of the leg 35 having the occlusional deposit 55 in the external iliac artery 23.
  • peripheral artery disease can occur in peripheral arteries located throughout the body.
  • the present invention can be used to treat peripheral arter disease anywhere in the body including, but not limited to, the extremity limbs (i.e., the legs, feet, arms and hands), heart and brain.
  • the ultrasonic probe 15 can be used to ablate occlusional deposits causing peripheral artery disease in the vasculature in other parts of the body and be within the spirit and scope of the present invention. Subsequent discussion of peripheral artery disease will focus on peripheral artery disease in the leg 35 of the patient, and more specifically in the external iliac artery 23, but the discussion is applicable to treatment of peripheral artery disease throughout the body.
  • the abdominal aorta 20 bifurcates at an iliac bifurcation 19 into common iliac arteries 21.
  • the common iliac arteries 21 separate into the internal iliac arteries 2 and continue on as the external iliac arteries 23.
  • the internal iliac arteries 22 supply the pelvis with blood and oxygen.
  • the external iliac arteries 23 become the common femoral arteries 34.
  • the common femoral artery 34 branches into the profunda femoral artery 25 as the superficial femoral artery 36 continues and passes into the popliteal fossa where the superficial femoral artery 36 is renamed the popliteal artery 27.
  • the popliteal artery 27 trifurcates into the anterior tibialis artery 38, the posterior tibialis artery 30 and the peroneal artery 29.
  • peripheral artery disease is a form of atherosclerosis in which the occlusional deposits 55 build up along the artery walls resulting in damage to the vessel wall by atheroma.
  • Atheroma is a fatty deposit in the intima of the artery resulting from atherosclerosis.
  • Peripheral artery disease is specific to partially or totally occlusive diseases of the peripheral arteries. When the buildup of the occlusional deposits 55 commences, there is an increase in vessel resistance that leads to a reduction in distal perfusion pressure and blood flow. As the occlusional deposits 55 build up, the effective radius of the afflicted peripheral artery is decreased.
  • Equation 1 shows the relationship between the resistance to blood flow (R), the length of the peripheral artery segment (L), the viscosity of the blood ( ⁇ ) and the radius of the peripheral artery segment (r).
  • Equation 3 Poiseuille's equation shown below as Equation 3.
  • the decrease in flow by a factor of sixteen assumes laminar flow conditions, a constant pressure gradient and the peripheral artery segment is not one of multiple in series segments.
  • major arteries of limb circulation are both in series and in parallel, a stenotic lesion would have to have its radius decreased by more than sixty percent to result in a significant hydrodynamic effect such as a critical stenosis.
  • the presence of turbulence in the peripheral artery segment enhances the longitudinal pressure drop across the length of the occlusional deposit for any reduction in radius of the peripheral artery segment.
  • the peripheral artery disease leads to ischemia of the limb, where the limb does not receive an adequate oxygen supply.
  • the increased resistance to blood flow leads to decreased flow capacity through the peripheral artery, known as decreased active hyperemia.
  • This condition results in ischemic pain known as intermittent claudication, a pain caused by tissue hypoxia resulting from the high oxygen demand that is not met by an adequate increase in the delivery of oxygen through increased blood flow.
  • This condition results in a reduction in the oxygen supply/demand ratio. Metabolites formed under anaerobic conditions in the muscle stimulate pain receptors in the muscle.
  • the access to the occlusional deposit 55 is from the side opposite of the occlusional deposit 55, an approach known as the contralateral approach.
  • the contralateral approach for example, in the embodiments of the present invention shown in FIG. 1 and FIG.
  • access to the occlusional deposit 55 is from the same side as the occlusional deposit 55, an approach known as the ipsilateral approach.
  • access is gained through the iliac artery 21 of the leg 56.
  • access is gained through the popliteal artery 27 of the leg 56.
  • a femoral puncture is made after locating the femoral artery 34 in the leg 56 opposite of the occlusional deposit 55.
  • the puncture creates an insertion point in the femoral artery 34 in the leg 56.
  • a guidewire is deployed in the femoral artery 34 and passed up and over the iliac bifurcation and down toward the occlusional deposit 55.
  • the ultrasonic probe 15 is used in place of the guidewire.
  • An introducer is inserted over the standard guidewire through the femoral puncture and a guide catheter is advanced within the introducer and moved proximal to the occlusional deposit 55.
  • contrast is injected into the femoral artery 34 to help locate the occlusional deposit 55.
  • the ultrasonic probe 15 of the present invention is inserted into the femoral puncture and placed across the occlusional deposit 55.
  • the guide catheter is advanced across the occlusional deposit 55 and the guide catheter is pulled back to expose the ultrasonic probe 15.
  • the ultrasonic probe 15 of the present invention is advanced across the occlusional deposit 55.
  • a device including, but not limited to, a vascular introducer can be used as the introducer to gain access to the peripheral artery.
  • a vascular introducer for use with an ultrasonic probe is described in Assignee's co-pending patent application U.S. Serial No. 10/080,787, and the entirety of this application is hereby incorporated herein by reference, hi another embodiment of the present invention a sheath is used to gain access to the peripheral artery. In another embodiment of the present invention, a catheter is used to gain access to the peripheral artery.
  • the ultrasonic probe 15 of the present invention is advanced to the occlusional deposit 55 without using an introducer, sheath or catheter.
  • the ultrasonic probe can be advanced adjacent the occlusional deposit in many ways known in the art and be within the spirit and scope of the present invention.
  • FIG. 8 shows an enlarged view of a portion of the ultrasonic probe 15 of the present invention inserted into the external iliac artery 23 of the leg 35 being moved toward the occlusional deposit 55.
  • the ultrasonic probe 15 has a stiffness that gives the ultrasonic probe 15 a flexibility allowing the ultrasonic probe 15 to be deflected, flexed and bent through the tortuous paths of the peripheral arteries.
  • the ultrasonic probe 15 can be bent, flexed and deflected to reach the occlusional deposit 55 in the peripheral arteries that would otherwise be difficult to reach.
  • the stiffness of the ultrasonic probe 15 allows for the contralateral approach of the ultrasonic probe 15 without deforming the ultrasonic probe 15, damaging the vasculature the ultrasonic probe 15 is moving through, or dampening vibrations of the ultrasonic probe 15.
  • FIG. 9 shows an enlarged view of a portion of the longitudinal axis of the ultrasonic probe 15 in communication with the occlusional deposit 55 in the external iliac artery 23 of the leg 35.
  • the ultrasonic probe 15 is moved within the external artery and placed in communication with the occlusional deposit 55.
  • the ultrasonic probe 15 is used to create a channel through the occlusional deposit 55.
  • a pharmacological agent is injected into the peripheral artery to soften or break down the occlusional deposit 55.
  • the probe tip 9 comprises a material of high radiopacity or a radiopaque marker
  • a distal end of the guide catheter comprises a material of high radiopacity or a radiopaque marker.
  • a treatment zone of the ultrasonic energy can be seen by the radiopaque tip 9 of the ultrasonic probe 15 and the radiopaque distal end of the guide catheter.
  • a material of high radiopacity does not allow the passage of a substantial amount of x- rays or other radiation and therefore allows a higher degree of visibility in an imaging procedure.
  • An ultrasonic medical device comprising a material of high radiopacity is described in Assignee's U.S.
  • Patent No. 6,730,048 and an ultrasonic medical device comprising a radiopaque marker is described in Assignee's co-pending patent application U.S. Serial No. 10/207,468 (published patent application No. 2004/0019266), and the entirety of this patent and patent application are hereby incorporated herein by reference.
  • the ultrasonic energy source 99 is activated to provide a low power electric signal of between about 2 watts to about 15 watts to the transducer that is located within the handle 88.
  • the transducer converts electrical energy provided by the ultrasonic energy source 99 to mechanical energy.
  • the operating frequency of the ultrasonic medical device 11 is set by the transducer and the ultrasonic energy source 99 finds the resonant frequency of the transducer through a Phase Lock Loop.
  • the horn creates a longitudinal wave along at least a portion of the longitudinal axis of the ultrasonic probe 15.
  • the longitudinal wave is converted to a transverse wave along at least a portion of the longitudinal axis of the ultrasonic probe 15 through a nonlinear dynamic buckling of the ultrasonic probe 15.
  • a transverse ultrasonic vibration is created along the longitudinal axis of the ultrasonic probe 15.
  • the ultrasonic probe 15 is vibrated in a transverse mode of vibration.
  • the transverse mode of vibration of the ultrasonic probe 15 differs from an axial (or longitudinal) mode of vibration disclosed in the prior art.
  • the transverse ultrasonic vibrations along the longitudinal axis of the ultrasonic probe 15 create a plurality of transverse nodes and a plurality of transverse anti-nodes along a portion of the longitudinal axis of the ultrasonic probe 15.
  • FIG. 10 shows the ultrasonic probe 15 of the present invention having a plurality of transverse nodes 40 and a plurality of transverse anti-nodes 42 along a portion of the longitudinal axis of the ultrasonic probe 15 and in communication with the occlusional deposit 55.
  • the transverse nodes 40 are areas of minimum energy and minimum vibration that occur at repeating intervals along the portion of the longitudinal axis of the ultrasonic probe 15.
  • the number of transverse nodes 40 and transverse anti-nodes 42, and the spacing of the transverse nodes 40 and transverse anti-nodes 42 of the ultrasonic probe 15 depend on the frequency of energy produced by the ultrasonic energy source 99.
  • the separation of the transverse nodes 40 and transverse anti-nodes 42 is a function of the frequency, and can be affected by tuning the ultrasonic probe 15. In a properly tuned ultrasonic probe 15, the transverse anti-nodes 42 will be found at a position one- half of the distance between the transverse nodes 40 located adjacent to each side of the transverse anti-nodes 42.
  • the transverse wave is transmitted along the longitudinal axis of the ultrasonic probe 15 and the interaction of the surface of the ultrasonic probe 15 with the medium surrounding the ultrasonic probe 15 creates an acoustic wave in the surrounding medium.
  • the transverse wave is transmitted along the longitudinal axis of the ultrasonic probe 15, the ultrasonic probe 15 vibrates transversely.
  • the transverse motion of the ultrasonic probe 15 produces cavitation in the medium surrounding the ultrasonic probe 15 to ablate the occlusional deposit 55.
  • Cavitation is a process in which small voids are formed in a surrounding medium through the rapid motion of the ultrasonic probe 15 and the voids are subsequently forced to compress.
  • the compression of the voids creates a wave of acoustic energy which acts to dissolve the matrix binding the occlusional deposit 55, while having no damaging effects on healthy tissue.
  • the occlusional deposit 55 in the peripheral artery is resolved into a particulate having a size on the order of red blood cells (approximately 5 microns in diameter).
  • the size of the particulate is such that the particulate is easily discharged from the body through conventional methods or simply dissolves into the blood stream.
  • a conventional method of discharging the particulate from the body includes transferring the particulate through the blood stream to the kidney where the particulate is excreted as bodily waste.
  • the transverse ultrasonic vibration of the ultrasonic probe 15 results in a portion of the longitudinal axis of the ultrasonic probe 15 vibrated in a direction not parallel to the longitudinal axis of the ultrasonic probe 15.
  • the transverse vibration results in movement of the longitudinal axis of the ultrasonic probe 15 in a direction approximately perpendicular to the longitudinal axis of the ultrasonic probe 15.
  • Transversely vibrating ultrasonic probes for biological material ablation are described in the Assignee's U.S. Patent No. 6,551,337; U.S. Patent No. 6,652,547; U.S. Patent No. 6,660,013; and U.S. Patent No. 6,695,781, which further describe the design parameters for such an ultrasonic probe and its use in ultrasonic devices for ablation, and the entirety of these patents are hereby incorporated herein by reference.
  • the occlusional deposit destroying effects of the ultrasonic medical device 11 are not limited to those regions of the ultrasonic probe 15 that may come into contact with the occlusional deposit 55. Rather, as a section of the longitudinal axis of the ultrasonic probe 15 is positioned in proximity to the occlusional deposit 55, the occlusional deposit 55 is removed in all areas adjacent to the plurality of energetic transverse anti-nodes 42 that are produced along the portion of the length of the longitudinal axis of the ultrasonic probe 15, typically in a region having a radius of up to about 6 mm around the ultrasonic probe 15.
  • a novel feature of the present invention is the ability to utilize ultrasonic probes 15 of extremely small diameter compared to prior art probes, without loss of efficiency, because the occlusional deposit fragmentation process is not dependent on the area of the probe tip 9.
  • Highly flexible ultrasonic probes 15 can therefore be designed for facile insertion into occluded areas or extremely narrow interstices that contain the occlusional deposit 55.
  • Another advantage provided by the present invention is the ability to rapidly remove the occlusional deposit 55 from large areas within cylindrical or tubular surfaces.
  • the number of transverse nodes 40 and transverse anti-nodes 42 occurring along the longitudinal axis of the ultrasonic probe 15 is modulated by changing the frequency of energy supplied by the ultrasonic energy source 99.
  • the exact frequency, however, is not critical and the ultrasonic energy source 99 ran at, for example, about 20 kHz is sufficient to create an effective number of occlusional deposit destroying transverse anti-nodes 42 along the longitudinal axis of the ultrasonic probe 15.
  • the low frequency requirement of the present invention is a further advantage in that the low frequency requirement leads to less damage to healthy tissue.
  • the ultrasonic probe 15 including diameter, length and distance to the ultrasonic energy source 99, in order to affect the number and spacing of the transverse nodes 40 and transverse anti-nodes 42 along a portion of the longitudinal axis of the ultrasonic probe 15.
  • the present invention allows the use of ultrasonic energy to be applied to the occlusional deposit 55 selectively, because the ultrasonic probe 15 conducts energy across a frequency range from about 10 kHz through about 100 kHz.
  • the amount of ultrasonic energy to be applied to a particular treatment site is a function of the amplitude and frequency of vibration of the ultrasonic probe 15.
  • the amplitude or throw rate of the energy is in the range of about 25 microns to about 250 microns, and the frequency in the range of about 10 kHz to about 100 kHz.
  • the frequency of ultrasonic energy is from about 20 kHz to about 40 kHz.
  • FIG. 11 shows an enlarged view of the ultrasonic probe 15 of the present invention in communication with a partially ablated occlusional deposit 55 in the external iliac artery 23.
  • the transverse motion of the ultrasonic probe 15 produces cavitation in the medium surrounding the ultrasonic probe 15 to ablate the occlusional deposit 55.
  • FIG. 11 is a view of the ablation process where the entire occlusional deposit 55 causing the peripheral artery disease is removed.
  • FIG. 12 shows an enlarged view of the external iliac artery 23 with the occlusional deposit 55 removed after treatment with the ultrasonic medical device 11 of the present invention, hi an embodiment of the present invention, a residual portion of the occlusional deposit 55 remains in the vasculature after treatment with the ultrasonic medical device 11.
  • the occlusional deposit 55 is removed and does not remain in the vasculature after treatment with the ultrasonic medical device 11.
  • varying amounts of residual occlusional deposit can remain in t the vasculature and still be within the spirit and scope of the present invention.
  • the present invention also provides a method of treating peripheral artery disease.
  • a medical professional gains access to the peripheral artery in the leg 35 through an insertion point or puncture in the peripheral artery in the opposite leg having the occlusional deposit 55.
  • the insertion point is in the peripheral artery on same leg having the occlusional deposit 55.
  • the ultrasonic probe 15 of the present invention is inserted into the vasculature and moved up and across the iliac bifurcation and adjacent to the occlusional deposit 55.
  • the ultrasonic probe 15 is placed in communication with the occlusional deposit 55 by moving, sweeping, twisting, bending or rotating the ultrasonic probe 15 along the occlusional deposit 55.
  • the ultrasonic probe 15 is placed in communication with the occlusional deposit 55 and the ultrasonic energy source 99 engaged to the ultrasonic probe 15 is activated to generate a transverse ultrasonic vibration along at least a portion of the longitudinal axis of the ultrasonic probe 15.
  • the transverse ultrasonic vibration creates a plurality of transverse nodes 40 and a plurality of transverse anti-nodes 42 along a portion of the longitudinal axis of the ultrasonic probe 15.
  • the present invention also provides a method of treating peripheral artery disease to decrease the vessel resistance resulting from the buildup of the occlusional deposit 55 along the inner walls of the vasculature.
  • the present invention provides a method of resolving the occlusional deposit 55 to a particulate so the effective radius of the afflicted peripheral artery is returned to the radius without the buildup of the occlusional deposit.
  • Access to a peripheral artery is gained and the ultrasonic probe 15 is inserted into an insertion point in the leg 56 opposite of the leg 35 having the occlusional deposit 55 (contralateral approach) or the insertion point is in the same leg having the occlusional deposit 55 (ipsilateral approach).
  • the ultrasonic probe 15 is moved adjacent to the occlusional deposit 55 and placed in communication with the occlusional deposit 55.
  • the ultrasonic energy source 99 engaged to the ultrasonic probe 15 produces an electric signal that drives a transducer of the ultrasonic medical device to produce a transverse ultrasonic vibration of the ultrasonic probe 15 that produces cavitation in a medium surrounding the ultrasonic probe 15 to ablate the occlusional deposit 55.
  • the ultrasonic probe 15 is vibrated in a torsional mode, hi the torsional mode of vibration, a portion of the longitudinal axis of the ultrasonic probe 15 comprises a radially asymmetric cross section and the length of the ultrasonic probe 15 is chosen to be resonant in the torsional mode, hi the torsional mode of vibration, a transducer transmits ultrasonic energy received from the ultrasonic energy source 99 to the ultrasonic probe 15, causing the ultrasonic probe 15 to vibrate torsionally.
  • the ultrasonic energy source 99 produces the electrical energy that is used to produce a torsional vibration along the longitudinal axis of the ultrasonic probe 15.
  • the torsional vibration is a torsional oscillation whereby equally spaced points along the longitudinal axis of the ultrasonic probe 15 including the probe tip 9 vibrate back and forth in a short arc about the longitudinal axis of the ultrasonic probe 15.
  • a section proximal to each of a plurality of torsional nodes and a section distal to each of the plurality of torsional nodes are vibrated out of phase, with the proximal section vibrated in a clockwise direction and the distal section vibrated in a counterclockwise direction, or vice versa.
  • the torsional vibration results in an ultrasonic energy transfer to the biological material with minimal loss of ultrasonic energy that could limit the effectiveness of the ultrasonic medical device 11.
  • the torsional vibration produces a rotation and a counterrotation along the longitudinal axis of the ultrasonic probe 15 that creates the plurality of torsional nodes and a plurality of torsional anti-nodes along a portion of the longitudinal axis of the ultrasonic probe 15 resulting in cavitation along the portion of the longitudinal axis of the ultrasonic probe 15 comprising the radially asymmetric cross section in a medium surrounding the ultrasonic probe 15 that ablates the biological material.
  • the ultrasonic probe 15 is vibrated in a torsional mode and a transverse mode.
  • a transducer transmits ultrasonic energy from the ultrasonic energy source 99 to the ultrasonic probe 15, creating a torsional vibration of the ultrasonic probe 15.
  • the torsional vibration induces a transverse vibration along an active area of the ultrasonic probe 15, creating a plurality of nodes and a plurality of anti-nodes along the active area that result in cavitation in a medium surrounding the ultrasonic probe 15.
  • the active area of the ultrasonic probe 15 undergoes both the torsional vibration and the transverse vibration.
  • the transverse vibration is excited by the torsional vibration. Coupling of the torsional mode of vibration and the transverse mode of vibration is possible because of common shear components for the elastic forces.
  • the transverse vibration is induced when the frequency of the transducer is close to a transverse resonant frequency of the ultrasonic probe 15.
  • the combination of the torsional mode of vibration and the transverse mode of vibration is possible because for each torsional mode of vibration, there are many close transverse modes of vibration.
  • the transverse vibration is tuned into coincidence with the torsional vibration.
  • the bending causes a shift in frequency due to changes in tension.
  • the active area of the ultrasonic probe 15 is vibrated in a direction not parallel to the longitudinal axis of the ultrasonic probe 15 while equally spaced points along the longitudinal axis of the ultrasonic probe 15 vibrate back and forth in a short arc about the longitudinal axis of the ultrasonic probe 15.

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  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

L’invention concerne un appareil et un procédé pour un dispositif médical à ultrasons (11) utilisé pour traiter une maladie artérielle périphérique. Le dispositif médical à ultrasons (11) comprend une sonde à ultrasons (15) présentant une extrémité proximale (31), une extrémité distale (24) séparées par un axe longitudinal. La sonde à ultrasons (15) est insérée dans un point d’insertion dans une jambe (56) opposée à la jambe (35) présentant un dépôt occlusif (55) et est placée en position adjacente au dépôt occlusif (55). Une source d’énergie ultrasonore (99) est activée pour générer une vibration ultrasonore transversale le long d’une partie au moins de l’axe longitudinal de la sonde à ultrasons (15). La vibration ultrasonore transversale crée une pluralité de nœuds transversaux (40) et une pluralité ventres transversaux (42) le long de l’axe longitudinal de la sonde à ultrasons (15), en créant une cavitation dans un milieu entourant la sonde à ultrasons (15) pour réaliser l’ablation du dépôt occlusif (55) à l’origine de la maladie artérielle périphérique.
PCT/US2004/032991 2004-10-07 2004-10-07 Appareil et procede pour dispositif medical a ultrasons utilise pour traiter une maladie arterielle peripherique Ceased WO2006041481A1 (fr)

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PCT/US2004/032991 WO2006041481A1 (fr) 2004-10-07 2004-10-07 Appareil et procede pour dispositif medical a ultrasons utilise pour traiter une maladie arterielle peripherique

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6733451B2 (en) * 1999-10-05 2004-05-11 Omnisonics Medical Technologies, Inc. Apparatus and method for an ultrasonic probe used with a pharmacological agent

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6733451B2 (en) * 1999-10-05 2004-05-11 Omnisonics Medical Technologies, Inc. Apparatus and method for an ultrasonic probe used with a pharmacological agent

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