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  Devices and methods for performing procedures on a breastUSPTO Application #: 20070203428Title: Devices and methods for performing procedures on a breast Abstract: A device for cutting tissue having a bowed cutting element may include a shaft having a central axis and a tissue cutting element coupled to the shaft. The tissue cutting element may be movable from a collapsed position to an expanded position and may bow outwardly when in the expanded position. The cutting element generally moves in a first plane when moving between the collapsed and expanded positions. The shaft may have a first thickness and a second thickness relative to the central axis of the shaft. The first and second thicknesses may lie in a second plane which is generally parallel to the first plane. The second thickness may be at least 1.25 times larger than the first thickness and the side of the shaft may have the second thickness leading the cutting element during rotation. (end of abstract) Agent: Young Law Firm, P.C. Alan W. Young - Portola Valley, CA, US Inventors: James W. Vetter, Sean C. Daniel USPTO Applicaton #: 20070203428 - Class: 600564000 (USPTO) Related Patent Categories: Surgery, Diagnostic Testing, Sampling Nonliquid Body Material (e.g., Bone, Muscle Tissue, Epithelial Cells, Etc.), Cutting The Patent Description & Claims data below is from USPTO Patent Application 20070203428. Brief Patent Description - Full Patent Description - Patent Application Claims
CROSS REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional of application Ser. No. 10/923,511, filed Aug. 20, 2004, which is a continuation-in-part of application Ser. No. 10/732,670, filed Dec. 9, 2003, and a continuation-in-part of application Ser. No. 10/272,448, filed Oct. 16, 2002, now U.S. Pat. No. 6,936,014, issued Aug. 30, 2005, and a continuation-in-part of application Ser. No. 10/796,328, filed Mar. 8, 2004, which is a continuation of application Ser. No. 09/417,520, filed Oct. 13, 1999, now U.S. Pat. No. 6,423,081, issued Jul. 23, 2002, which is a divisional of application Ser. No. 09/146,743, filed Sep. 3, 1998, now U.S. Pat. No. 6,022,362, issued Feb. 8, 2000, all applications and patents of which are hereby incorporated herein by reference in their entireties and from which priority is hereby claimed under 35 U.S.C. .sctn.119(e) and .sctn.120. BACKGROUND OF THE INVENTION [0002] Breast cancer is a major threat and concern to women. Early detection and treatment of suspicious or cancerous lesions in the breast has been shown to improve long term survival of the patient. The trend is, therefore, to encourage women not only to perform monthly self-breast examination and obtain a yearly breast examination by a qualified physician, but also to undergo annual screening mammography commencing at age 40. Mammography is used to detect small, nonpalpable lesions which may appear opaque densities relative to normal breast parenchyma and fat or as clusters of microcalcifications. The conventional method for diagnosing, localizing and excising nonpalpable lesions detected by mammography generally involves a time-consuming, multi-step process. First, the patient goes to the radiology department where the radiologist finds and localizes the lesion either using mammography or ultrasound guidance. Once localized, a radio-opaque wire is inserted into the breast. The distal end of the wire may include a small hook or loop. Ideally, this is placed adjacent to the suspicious area to be biopsied. The patient is then transported to the operating room. [0003] Under general or local anesthesia, the surgeon may then perform a needle-localized breast biopsy. In this procedure, the surgeon, guided by the wire previously placed in the patient's breast, excises a mass of tissue around the distal end of the wire. The specimen is sent to the radiology department where a specimen radiograph is taken to confirm that the suspicious lesion is contained within the excised specimen. Meanwhile, the surgeon, patient, anesthesiologist and operating room staff, wait in the operating room for confirmation of that fact from the radiologist before the operation is completed. The suspicious lesion should then be excised in toto with a small margin or rim of normal breast tissue on all sides. Obtaining good margins of normal tissue using conventional techniques is extremely dependent upon the skill and experience of the surgeon, and often an excessively large amount of normal breast tissue is removed to ensure that the lesion is located within the specimen. This increases the risk of post-operative complications, including bleeding and permanent breast deformity. As 80% of breast biopsies today are benign, many women unnecessarily suffer from permanent scarring and deformity from such benign breast biopsies. [0004] More recently, less invasive techniques have been developed to sample or biopsy the suspicious lesions to obtain a histological diagnosis. The simplest of the newer techniques is to attempt visualization of the lesion by external ultrasound. If seen by external ultrasound, the lesion can be biopsied while being continuously visualized. This technique allows the physician to see the biopsy needle as it actually enters the lesion, thus ensuring that the correct area is sampled. Current sampling systems for use with external ultrasound guidance include a fine needle aspirate, core needle biopsy or vacuum-assisted biopsy devices. [0005] Another conventional technique localizes the suspicious lesion using stereotactic digital mammography. The patient is placed prone on a special table that includes a hole to allow the breast to dangle therethrough. The breast is compressed between two mammography plates, which stabilizes the breast to be biopsied and allows the digital mammograms to be taken. At least two images are taken 30 degrees apart to obtain stereotactic views. The x, y and z coordinates targeting the lesion are calculated by a computer. The physician then aligns a special mechanical stage mounted under the table that places the biopsy device into the breast to obtain the sample or samples using fine needle aspiration, core needle biopsy, vacuum-assisted core needle biopsy or other suitable method. Fine needle aspiration uses a small gauge needle, usually 20 to 25 gauge, to aspirate a small sample of cells from the lesion or suspicious area. Core needle biopsy uses a larger size needle, usually 14 gauge to sample the lesion. Tissue architecture and histology are preserved with this method. Multiple penetrations of the core needle through the breast and into the lesion are required to obtain an adequate sampling of the lesion. Over 10 samples have been recommended by some. The vacuum-assisted breast biopsy system is a larger semi-automated side-cutting device. It is usually 11 gauge in diameter and is more sophisticated than the core needle biopsy device. Multiple large samples can be obtained from the lesion without having to reinsert the needle each time. A vacuum is added to suck the tissue into the trough. The rapid firing action of the spring-loaded core needle device is replaced with an oscillating outer cannula that cuts the breast tissue off in the trough. The physician controls the speed at which the outer cannula advances over the trough and can rotate the alignment of the trough in a clockwise fashion to obtain multiple samples. [0006] If a fine needle aspirate, needle core biopsy or vacuum-assisted biopsy shows malignancy or a specific benign diagnosis of atypical hyperplasia, then the patient needs to undergo another procedure, the traditional needle-localized breast biopsy, to fully excise the area with an adequate margin of normal breast tissue. Sometimes the vacuum-assisted device removes the whole targeted lesion. If this occurs, a small titanium clip should be placed in the biopsy field. This clip marks the area if a needle-localized breast biopsy is subsequently required for the previously mentioned reasons. [0007] Another method of biopsying the suspicious lesion utilizes a large end-cutting core device measuring 0.5 cm to 2.0 cm in diameter. This also uses the stereotactic table for stabilization and localization. After the lesion coordinates are calculated and local anesthesia instilled, an incision large enough is permit entry of the bore is made at the entry site with a scalpel. The breast tissue is cored down to and past the lesion. Once the specimen is retrieved, the patient is turned onto her back and the surgeon cauterizes bleeding vessels under direct vision. The incision, measuring 0.5 to larger than 2.0 cm is sutured closed. The newer conventional minimally invasive breast biopsy devices have improved in some ways the ability to diagnose mammographically detected nonpalpable lesions. These devices give the patient a choice as to how she wants the diagnosis to be made. SUMMARY OF THE INVENTION [0008] According to an embodiment thereof, the present invention is a device for cutting tissue having a bowed cutting element. The device may include a shaft having a central axis; and a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the cutting element moving generally in a first plane when moving between the collapsed and expanded positions; the shaft having a first thickness and a second thickness relative to the central axis of the shaft, the first and second thicknesses lying in a second plane which is generally parallel to the first plane, the second thickness being at least 1.25 times larger than the first thickness and the side of the shaft having the second thickness leading the cutting element during rotation. [0009] The second thickness may be at least 1.5 times larger than the first thickness. The tissue cutting device may have a tissue collection element which holds the tissue volume cut free from the surrounding tissue. [0010] According to another embodiment thereof, the present invention is also a device for cutting tissue using a bowed cutting element, comprising: a shaft; and a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the tissue cutting element moving generally in a first plane when moving between the collapsed and expanded positions; the shaft may be at least 1.25 times thicker on a leading side than on a trailing side, the thickness being measured along a second plane perpendicular to the first plane, the cutting device being rotated during cutting so that the leading side leads the cutting element. [0011] The shaft may be at least 1.5 times thicker on the leading side than on the trailing side. The shaft may be thicker on the leading side adjacent to the cutting element and may be substantially the same as the trailing side at substantially all other parts of the shaft. [0012] According to yet another embodiment thereof, the present invention is a method of cutting tissue using a bowed cutting element, comprising the steps of: providing a tissue cutting device having a shaft and a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the tissue cutting element moving generally in a first plane when moving between the collapsed and expanded positions, the shaft has a first and second thicknesses lying in a second plane which may be generally parallel to the first plane, the second thickness being on a side of the shaft from which the tissue cutting element expands, the second thickness being at least 1.25 times larger than the first thickness; introducing the tissue cutting device into tissue; expanding the tissue cutting element toward the expanded position; rotating the tissue cutting device so that the cutting element moves through the tissue to cut the tissue, the cutting device being rotated in a direction in which a side having the second thickness leads the cutting element during rotation; moving the tissue cutting element back toward the collapsed position to cut a tissue volume free from the surrounding tissue. [0013] The providing step may be carried out with the second thickness being at least 1.5 times larger than the first thickness. The providing step may be carried out with the tissue cutting device having a tissue collection element which holds the tissue volume cut free from the surrounding tissue. The providing step may be carried out with the shaft having at least the second thickness adjacent to the cutting element. [0014] According to yet another embodiment, the present invention is a method of cutting tissue using a bowed cutting element, comprising the steps of providing a tissue cutting device having a shaft and a tissue cutting element coupled to the shaft, the tissue cutting element being movable from a collapsed position to an expanded position, the cutting element bowing outwardly when in the expanded position, the tissue cutting element moving generally in a first plane when moving between the collapsed and expanded positions, the shaft may be at least 1.25 times thicker on a first side defined in the direction in the cutting element expands than a second side opposite the first side; introducing the tissue cutting device into tissue adjacent to a tissue volume to be removed; expanding the tissue cutting element toward the expanded position; rotating the shaft so that the cutting element moves through the tissue to cut around the tissue volume to be removed, the cutting device being rotated in a direction in which the first side of the shaft leads the cutting element during rotation; and moving the tissue cutting element back toward the collapsed position to cut a tissue volume free from the surrounding tissue. [0015] The providing step may be carried out with the shaft being at least 1.5 times thicker on the first side than on the second side. The providing step may be carried out with the shaft being thicker on the leading side adjacent to the cutting element and being substantially the same as the trailing side at substantially all other parts of the shaft which may be introduced into the tissue. [0016] A method of cutting a tissue mass free from surrounding breast tissue, according to still another embodiment of the present invention, may include steps of providing a tissue cutting device and a guide element, the tissue cutting device having a tissue cutting element movable from a collapsed position to an expanded position; inserting the guide element into a breast; advancing the tissue cutting device into the breast, the tissue cutting device being slidably coupled to the guide element so that the guide element guides advancement of the tissue cutting device into the breast; and cutting breast tissue with the tissue cutting device, the cutting step being carried out with the guide element indicating a cutting parameter for the cutting device. [0017] The cutting step may be carried out with the guide element providing an indication of a depth of penetration during the advancing step. A step may be carried out of indicating a first angular position relative to a longitudinal axis of the guide element. The indicating step may be carried out by also indicating a second angular orientation, the tissue area of interest lying between the first and second angular orientations for use during the cutting step. The advancing step may be carried out with the tissue cutting device being advanced over the guide element. The advancing step may be carried out with the tissue cutting device being advanced through the guide element. The providing step may be carried out with the guide element being a tube; the inserting step may be carried out with the tube having a sharp tip which pierces the breast tissue; and the advancing step may be carried out with the tissue cutting device being introduced into the tube. A step of removing hot gasses generated during the cutting step through the tube may also be carried out. The removing step may be carried out by removing the hot gasses through a space between the tube and the tissue cutting device. [0018] Still another embodiment of the present invention is a method of removing breast tissue, comprising the steps of providing a tissue cutting device and an insertion device having a sharp tip, the tissue cutting device having a cutting element which may be movable from a collapsed position to an expanded position, the cutting element being bowed outward when in the expanded position; inserting the insertion device into a breast with the sharp tip of the insertion device piercing the breast tissue during insertion; coupling the tissue cutting device to the insertion device so that the tissue cutting device may be slidably coupled to the insertion device; advancing the insertion device into the breast tissue while being slidably coupled to the insertion device; moving the tissue cutting element toward the expanded position after the withdrawing step; rotating the tissue cutting device to cut around the tissue to be removed; and removing the tissue which has been cut free from the surrounding tissue by the tissue cutting device. [0019] The providing step may be carried out with the insertion device having a tubular body, the sharp tip may be removable. A step of removing the cutting element after the inserting step may also be carried out; the coupling step being carried out by introducing the cutting device into the insertion device and advancing the cutting device through the tubular body. The guide member may be secured to the tissue structure to hold the angular orientation of the guide member after completing the inserting step. The securing step may be carried out using an adhesive strip which may be adhered to a surface of the tissue through which the cutting device may be inserted. The insertion device may be withdrawn after the advancing step to expose the tissue cutting element. A step of removing gas through a space between the tubular body and the cutting device may also be carried out. The removing step may be carried out by removing the tissue through a separate incision from an incision through which the tissue cutting element extends. An angular indicator may be set on the guide member, which provides an indication of an angular extent of the tissue to be removed. [0020] Another embodiment of the present invention is a method of forming an RF-energized bowed cutting element. The method may include steps of providing a tissue cutting device having a cutting element coupled to a shaft, the cutting element being movable from a collapsed position to an expanded position, the cutting element being in a substantially straight configuration when collapsed and bowing outwardly from the shaft when in the expanded position; and marking a first location on the cutting element corresponding to a position on the cutting element where an apex occurs when the cutting element may be bowed outwardly, the location being marked for visualization using ultrasound. [0021] The marking step may be carried out by also marking a second location corresponding to a proximal end and a third location corresponding to a distal end of the cutting element when the cutting element may be collapsed. Continue reading... Full patent description for Devices and methods for performing procedures on a breast Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Devices and methods for performing procedures on a breast patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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