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  Intraluminal guidance system using bioelectric impedanceUSPTO Application #: 20070255270Title: Intraluminal guidance system using bioelectric impedance Abstract: A system using bioelectric impedance to guide a flexible elongate transluminal device through an occlusion in a vessel. The device can be a guidewire or a device for performing an atherectomy, discectomy, ablation or similar technique. The device includes a first electrode disposed on a distal portion of the device. A second electrode is disposed in electric contact with the patient separate from the first electrode. An electric current is supplied between the first and second electrodes and a voltage drop is measured between the first and second electrodes. The voltage drop is converted to bioelectric impedance. Based on the impedance measurement, a clinician can determine if the device is approaching the vessel wall, permitting the clinician to redirect the device away from the vessel wall. (end of abstract)
Agent: Medtronic Vascular, Inc.IPLegal Department - Santa Rosa, CA, US Inventor: Alan Oliver Carney USPTO Applicaton #: 20070255270 - Class: 606035000 (USPTO) Related Patent Categories: Surgery, Instruments, Electrical Application, Systems, Ground Electrode Monitoring The Patent Description & Claims data below is from USPTO Patent Application 20070255270. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] The disclosure relates generally to a guidance system for use in a patient's vessel, and more particularly, to a system for guiding an intra-luminal device through an arterial chronic total occlusion (CTO) using bioelectric impedance. BACKGROUND OF THE INVENTION [0002] Stenotic lesions may comprise a hard, calcified substance and/or a softer thrombus material, each of which forms on the lumen walls of a blood vessel and restricts blood flow there through. Intra-luminal treatments, such as balloon angioplasty, stent deployment, atherectomy, and thrombectomy are well known and have proven effective in the treatment of such stenotic lesions. These treatments often involve the insertion of a therapy catheter into a patient's vasculature, which may be torturous and may have numerous stenoses of varying degrees throughout its length. In order to place the distal, treatment portion of a catheter within the treatment site, a steerable guidewire is typically introduced and tracked from an incision, through the vessels, and across the lesion. Then, a catheter, e.g., a balloon catheter, perhaps carrying a stent, can be tracked over the guidewire to the treatment site. Ordinarily, the distal end of the guidewire is quite flexible so that as it is directed, or steered through the lumen, it can find its way through the turns of the typically irregular passageway without perforating or otherwise damaging the vessel wall. [0003] In some instances, the extent of occlusion of the lumen is so severe that the lumen is completely or nearly completely obstructed, leaving virtually no passageway for the guidewire. Such a condition may be described as a total occlusion. If this occlusion persists for a long period of time, the lesion is referred to as a chronic total occlusion or CTO. Furthermore, in the case of diseased blood vessels, the lining of the vessels may be characterized by the prevalence of atheromatous plaque, which may form total occlusions. The extensive plaque formation of a chronic total occlusion typically has a fibrous cap surrounding softer plaque material. This fibrous cap may present a surface that is difficult to penetrate with a conventional guidewire, and the typically flexible distal tip of the guidewire may be unable to cross the lesion. [0004] Thus, for treatment of total occlusions, guidewire having stiffer distal tips have been employed to recanalize a total occlusion. However, blood vessels are not straight and fluoroscopic visualization of the natural path through an occlusion is poor because there is little or no flow of radiographic contrast through the occlusion. Therefore, simply using a stiffer guidewire to push through an occlusion increases the risk that the guidewire tip will penetrate the vessel wall. [0005] Atherectomy is another established treatment for occlusions. Atherectomy procedures typically involve inserting a cutting or ablating device through the access artery, e.g. the femoral artery or the radial artery, and advancing it through the vascular system to the occluded region, and rotating the device at high speed via a drive shaft to cut through or ablate the plaque over the wire. The removed plaque or material can then be suctioned out of the vessel or be of such fine diameter that it is cleared by the reticuloendothelial system. Atherectomy devices also present the danger of unwanted perforation of a vessel wall by the material removal device. This can occur when the material removal device improperly engages the vessel wall, for example when the material removal device is not oriented substantially parallel to the axis of the vessel. In this situation, the material removal device, e.g. cutter or abrasive ablator, may improperly engage the vessel wall and cause unwanted damage thereto. Other ablation and discectomy devices also present the danger of damage to a vessel wall. [0006] Thus, there is a need for a device and method to reduce the risk of damage to a vessel wall when a guidewire or a device for performing an atherectomy, discectomy, ablation or similar procedure is crossing an occlusion. [0007] Electrical impedance is the opposition to the flow of an alternating current, which is the vector sum of ohmic resistance plus additional resistance, if any, due to induction, to capacitance, or to both. Bioelectric impedance is known, e.g., for use in measuring body fat composition. For example, bathroom scales may include means to measure body fat composition using bioelectric impedance. According to this technique, a person's body fat is measured by determining the impedance of the person's body to electrical signals, and calculating the percent body fat based upon the measured impedance and other variables, such as height, weight, age, and sex. [0008] Bioelectric impedance is typically determined by supplying a harmless electric current through at least two separated electrodes that contact portions of a body, and measuring a voltage across the body portion. This voltage is measured either (1) via the same electrodes through which current is supplied, or (2) via one or more distinct pairs of voltage-measuring electrodes. The bioelectric impedance is then readily calculated from the current and the measured voltage. The calculated bioelectric impedance may be compared to an expected value or range of common or known values, or it may be compared to one or more bioelectric impedance values previously measured in, and calculated for the same patient. BRIEF SUMMARY OF THE INVENTION [0009] The present disclosure is a system that uses bioelectric impedance to guide an elongate intraluminal device through an occlusion in a vessel. The device can be a medical guidewire or a therapeutic catheter for performing an angioplasty, atherectomy, discectomy, ablation or similar procedure. The device includes an electrode disposed on a distal portion of the device. A second electrode is disposed separately of the first electrode, either on the same device or on a separate device. For example, the second electrode may be mounted on a skin electrode or on a balloon of a catheter. The system provides an electric power source and an impedance monitor for connection to the first and second electrodes. [0010] During use of the above system to guide an elongate device through a vessel occlusion in a patient, a first electrode is disposed adjacent the occlusion targeted for crossing. A second electrode is spaced apart from the first electrode and disposed in electrical contact with the patient's tissue, e.g., against the wall of the occluded or another vessel. The second electrode may be a skin electrode in contact with the patient's skin. As the elongate device is advanced through the occlusion, an electric current is supplied between the first and second electrodes and a voltage drop is measured between the first and second electrodes. The voltage drop is converted arithmetically to a calculated bioelectric impedance. By comparing the measured/calculated bioelectric impedance to a known, e.g., expected standard or previously measured impedance, a clinician can determine whether the device is approaching the vessel wall and posing a risk of perforating the wall. With this information, the clinician can halt advancement of the device, and possibly redirect the device away from the vessel wall. BRIEF DESCRIPTION OF DRAWINGS [0011] The foregoing and other features and advantages of the disclosure will be apparent from the following description of the disclosure as illustrated in the accompanying drawings. The accompanying drawings, which are incorporated herein and form a part of the specification, further serve to explain the principles of the disclosure and to enable a person skilled in the pertinent art to make and use the disclosure. The drawings are not to scale. [0012] FIG. 1 is a partial cut-away view of a vessel including an occlusion and illustrating a system in accordance with an embodiment of the present disclosure. [0013] FIG. 2 illustrates the system as shown in FIG. 1, with the introduction of a microcatheter. [0014] FIG. 3 illustrates the system as shown in FIG. 2, with the introduction of a guidewire. [0015] FIG. 4 illustrates the system as shown in FIG. 3, with the guidewire advanced into the occlusion. [0016] FIG. 5 is a partial cut-away view of the system of FIGS. 1-4 illustrating a schematic representation of equipment outside of the vessel. [0017] FIG. 6 is a side view of a steerable guidewire of the present disclosure. [0018] FIG. 7 is a partial cut-away view of a vessel including an occlusion and illustrating another embodiment in accordance with the present disclosure. [0019] FIG. 8 is a cross-section of a vessel including an occlusion and showing another embodiment in accordance with the present disclosure. [0020] FIG. 9 is a plan view of a patient illustrating another embodiment in accordance with the present disclosure. Continue reading... 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