# US 2013/0253370 A1 · Devices and methods for performing procedures on a breast > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0253370 A1 - Document ID: US20130253370A1 - Status: Published application - Kind: A1 - Application number: 13/895,303 - Filed: 2013-05-15 - Published: 2013-09-26 - Earliest claimed: 2002-10-16 - Assignees: Encapsule Medical, LLC - Inventors: James W. Vetter; Scott C. Anderson; Jordan S. Tuttle; Daniel M. Brounstein - Web page: https://patentgrep.com/patent/US20130253370A1 ## CPC - A61B 10/0041: {Detection of breast cancer (mammography by transillumination A61B5/0091, by X-rays A61B6/502, by ultrasonic means A61B8/0825)} - A61B 10/0266: {means for severing sample} - A61B 10/04: Endoscopic instruments, e.g. catheter-type instruments - A61B 17/320016: {Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes (A61B10/0233, A61B17/29, A61B17/3207 take precedence)} - A61B 17/32056: {Surgical snare instruments (for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26)} - A61B 17/320725: {with radially expandable cutting or abrading elements (A61B17/32075 takes precedence)} - A61B 17/3476: {Powered trocars, e.g. electrosurgical cutting, lasers, powered knives} - A61B 18/1482: {having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy} - A61B 90/39: {Markers, e.g. radio-opaque or breast lesions markers} - A61B 10/02: Instruments for taking cell samples or for biopsy {(A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48)} - A61B 10/0283: {with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe (A61B10/025, A61B10/0266 take precedence)} - A61B 17/3439: {with means for changing the inner diameter of the cannula, e.g. expandable (A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662)} - A61B 18/14: Probes or electrodes therefor - A61B 18/148: {having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy} - A61B 2017/00734: {battery operated} - A61B 2017/008: {Removal of tumors} - A61B 2017/22034: {for gripping the obstruction or the tissue part from inside} - A61B 2017/22047: {Means for immobilising the guide wire in the patient} - A61B 2017/306: {holding by means of suction} - A61B 2017/3488: {Fixation to inner organ or inner body tissue} - A61B 2018/00011: {with fluids} - A61B 2018/1407: {Loop} - A61B 2018/1475: {Electrodes retractable in or deployable from a housing} - A61B 2090/3782: {transmitter or receiver in catheter or minimal invasive instrument} - A61B 2090/3908: {Soft tissue, e.g. breast tissue} - A61B 2217/005: with suction drainage system - A61B 2218/002: Irrigation - A61B 2218/007: Aspiration - A61B 2218/008: for smoke evacuation - A61M 1/85: {with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants (for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract A needle is used to mark a tissue area of interest. The needle may have one or more indicators which indicate selected angular orientations relative to the needle. The indicators may also be coupled to anchors which are deployed in the tissue to anchor the needle in the tissue. The needle may be positioned to guide an excisional device to remove tissue. ## Claims ### Claim 1 A method of positioning a needle in a patient's breast for a medical procedure, comprising the steps of: providing a needle having a proximal portion and a distal portion, the proximal portion being movable between a rigid condition and a flexible condition which may be selected by a user; positioning the distal portion in a patient's breast with the proximal portion remaining outside the breast, the distal portion being in the rigid condition for facilitating introduction into the patient's breast; changing the proximal portion from the rigid condition to the flexible condition after the positioning step; and performing a medical procedure on the patient's breast. ### Claim 2 (depends on 1) The method of claim 1, wherein: the performing step includes the step of removing breast tissue. ### Claim 3 (depends on 2) The method of claim 2, wherein: the performing step is carried out by removing tissue not penetrated by the needle. ### Claim 4 (depends on 1) The method of claim 1, further comprising the step of: creating another rigid condition at the proximal portion after the changing step and before the performing step. ### Claim 5 (depends on 1) The method of claim 1, wherein: the changing step is carried out by removing a stiffener from the proximal portion of the needle. ### Claim 6 (depends on 1) The method of claim 1, wherein: the performing step is carried out by guiding a cutting device into the patient using the needle to guide the cutting device. ### Claim 7 (depends on 1) The method of claim 1, wherein: the performing step is carried out with a tissue removal device being guided by the needle and the medical procedure being a tissue removal procedure. ### Claim 8 (depends on 7) The method of claim 7, wherein: the performing step is carried out with the tissue removal device rotating to move a cutting element along an arc within the tissue. ### Claim 9 (depends on 7) The method of claim 7, wherein: the performing step is carried out with the tissue removal device being rotationally constrained by the needle at a first location. ### Claim 10 (depends on 9) The method of claim 9, wherein: the performing step is carried out with the first location coinciding with a first angular indicator which indicates an angular position with respect to a longitudinal axis of the needle to the user. ### Claim 11 (depends on 7) The method of claim 7, wherein: the performing step is carried out with the tissue removal device having a cutting element which moves between bowed and retracted positions, the cutting element being in a bowed position while cutting tissue. ### Claim 12 (depends on 7) The method of claim 7, wherein: the performing step is carried out with the tissue removal device engaging a stop on the needle which prevents further longitudinal movement of the tissue removal device. ### Claim 13 (depends on 12) The method of claim 12, wherein: the performing step is carried out with the stop positioning the tissue removal device in a predetermined longitudinal position. ### Claim 14 (depends on 1) The method of claim 1, further comprising the step of: moving an indicator on the needle, the indicator being moved to a position which indicates an angular position with respect to a longitudinal axis of the needle. ### Claim 15 (depends on 14) The method of claim 14, wherein: the moving step is carried out with the position of the indicator providing an angular bound of tissue to be removed from the breast. ### Claim 16 A needle for marking a patient's breast when performing a medical procedure on the patient, comprising: a distal portion having an elongate, rigid shaft; and a proximal portion coupled to the distal portion, the proximal portion being selectively movable between a rigid condition and a flexible condition, wherein the proximal portion is in the rigid condition during introduction into a patient's breast and is movable to the flexible condition after introduction into the breast. ### Claim 17 (depends on 16) The needle of claim 16, wherein: the proximal portion has a removable stiffener. ### Claim 18 (depends on 16) The needle of claim 16, further comprising: an indicator which is movable to a selected angular orientation relative to a longitudinal axis. ### Claim 19 (depends on 16) The needle of claim 16, wherein: the needle has a longitudinal stop which prevents further longitudinal movement of a tissue removal device, the stop being oriented to position the tissue removal device in a predetermined longitudinal position relative to the tissue be removed after positioning the needle in the breast. ### Claim 20 (depends on 16) The needle of claim 16, further comprising: an anchoring element which is movable together with the indicator to a selected orientation relative to the longitudinal axis. ### Claim 21 (depends on 20) The needle of claim 20, wherein: the anchoring element is a thin, elongate element which pierces the breast tissue. ### Claim 22 (depends on 21) The needle of claim 21, further comprising: a shaft having an opening; the element extends through the opening in the shaft. ### Claim 23 (depends on 20) The needle of claim 20, wherein: the anchoring element is a J-shaped wire. ### Claim at position 24 24-54. (canceled)