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  Devices and methods for performing procedures on a breastUSPTO Application #: 20070203427Title: Devices and methods for performing procedures on a breast Abstract: A method may include steps of providing a tissue cutting device having a shaft and a cutting element. The cutting element may be movable from a collapsed position to an expanded position. The tissue cutting device may be introduced into the patient's breast through a first incision with the cutting element in the collapsed position. The cutting element may then be expanded. The cutting element may then be moved through breast tissue to cut around the tissue to be removed, and the breast tissue may be removed through a second incision that is different from the first incision. (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 #: 20070203427 - 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 20070203427. 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 method of removing breast tissue. The method may include steps of providing a tissue cutting device having a shaft and a cutting element, the cutting element being movable from a collapsed position to an expanded position; introducing the tissue cutting device into the patient's breast through a first incision with the cutting element in the collapsed position; expanding the cutting element; moving the cutting element through breast tissue to cut around the tissue to be removed; and removing the breast tissue through a second incision different from the first incision. [0009] The providing step may be carried out with the tissue removing device having a tissue collection element; and the removing step may be carried out with the tissue being carried in the tissue collection element. The providing step may be carried out with the cutting element being an RF cutting element, the RF cutting element bowing outward when moving from the first position to the second position. The method may be carried out with the forming step being carried out with the second incision being at least partially formed by the tissue cutting device. The method may also include a step of forming at least part of the second incision with the cutting element. The forming step may be carried out with the second incision being formed by the tip of the tissue cutting device piercing through the skin at the second incision so that the tissue cutting device is penetrates the first and second incisions. The forming step may be carried out with the second incision being created by the cutting element of the tissue cutting device. The method may also include a step of encapsulating the tissue to be removed in a tissue collection element. The removing step may be carried out with the tissue contained in the tissue collection element. The method may also include a step of releasing the tissue collection element; and the removing step may be carried out with the tissue contained within the tissue collection element when removed through the second incision. [0010] These and other aspects of the present invention will become apparent from the following drawings and description. BRIEF DESCRIPTION OF THE DRAWINGS [0011] FIG. 1 shows a needle made in accordance with the present invention. [0012] FIG. 2 shows a tissue removing device. [0013] FIG. 3 shows the needle introduced into a breast. [0014] FIG. 4 shows a first anchor deployed within the breast. [0015] FIG. 5 shows a second anchor deployed within the breast. [0016] FIG. 6 shows a stiffener removed to provide a flexible proximal end. [0017] FIG. 7 shows the flexible, proximal portion taped to the breast. [0018] FIG. 8 shows a tissue removing device advanced over the needle and a cutting element deployed. [0019] FIG. 9 is a perspective view of a combination introducer and suction sleeve, according to another embodiment of the present invention. [0020] FIG. 10 is a side cross-sectional view of the combination introducer and suction sleeve of FIG. 9. 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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