US20070197934A1 - Devices and methods for performing procedures on a breast - Google Patents
Devices and methods for performing procedures on a breast Download PDFInfo
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- US20070197934A1 US20070197934A1 US11/740,855 US74085507A US2007197934A1 US 20070197934 A1 US20070197934 A1 US 20070197934A1 US 74085507 A US74085507 A US 74085507A US 2007197934 A1 US2007197934 A1 US 2007197934A1
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/0041—Detection of breast cancer
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Definitions
- 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.
- 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.
- the surgeon may then perform a needle-localized breast biopsy.
- 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.
- 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.
- 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.
- a fine needle aspirate, needle core biopsy or vacuum-assisted biopsy shows malignancy or a specific benign diagnosis of atypical hyperplasia
- 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.
- 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.
- 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.
- a method of removing breast tissue may include steps of providing a tissue cutting device having a shaft, a tissue collection element 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; positioning the tissue cut by the cutting element into the tissue collection element; and removing the tissue collection element through a second incision different from the first incision.
- the removing step may be carried out with a removal device extending through the second incision, the removal step including the step of coupling the removal device to the tissue collection element.
- the removing step may be carried out with the removal device having a distal end movable between a collapsed position and an expanded position, the expanded position being flared outwardly.
- the removing step may be carried out with the removal device having a suction opening coupled to a vacuum source, the removal device adhering to the tissue collection element with the suction opening.
- FIG. 1 shows a needle made in accordance with the present invention.
- FIG. 2 shows a tissue removing device
- FIG. 3 shows the needle introduced into a breast.
- FIG. 4 shows a first anchor deployed within the breast.
- FIG. 5 shows a second anchor deployed within the breast.
- FIG. 6 shows a stiffener removed to provide a flexible proximal end.
- FIG. 7 shows the flexible, proximal portion taped to the breast.
- FIG. 8 shows a tissue removing device advanced over the needle and a cutting element deployed.
- FIG. 9 is a perspective view of a combination introducer and suction sleeve, according to another embodiment of the present invention.
- FIG. 10 is a side cross-sectional view of the combination introducer and suction sleeve of FIG. 9 .
- FIG. 11 is a perspective view of the combination introducer and suction sleeve of FIG. 9 , with a trocar inserted therein.
- FIG. 12 is a side cross-sectional view of the combination introducer and suction sleeve of FIG. 9 , illustrating exemplary structure with which the suction sleeve may attach to the interventional device.
- FIG. 13 is a perspective cross-sectional view of the combination introducer and suction sleeve, attached to an exemplary interventional device
- FIG. 14 is a perspective view of another embodiment of a suction sleeve according to the present invention, coupled to an exemplary interventional device.
- FIG. 15 shows another guide element used to introduced a cutting device into the tissue.
- FIG. 16 shows a piercing element removed from a lumen in the guide member.
- FIG. 17 shows a cutting device introduced into the guide element.
- FIG. 18 shows guide member retracted and anchored to the tissue with needles and an adhesive tape.
- FIG. 19 shows a perspective view of another guide member having a window through which the cutting element extends when cutting the tissue.
- FIG. 20 shows a tube which is cut to form a lip.
- FIG. 21 is a cross-sectional view of FIG. 21 along line I-I.
- FIG. 22 shows the tube of FIG. 21 covered with a shrink tube.
- FIG. 23 is a cross-sectional view of FIG. 23 along line II-II with the addition of a cutting element shown in an expanded or bowed configuration.
- FIG. 24 is a cross-sectional view of FIG. 23 along line III-III.
- FIG. 25 shows another device for cutting or incising tissue.
- FIG. 26 shows a removable core
- FIG. 27 is a cross-sectional view of the device of FIG. 26 along line A-A.
- FIG. 28 shows the removable core positioned within a sheath.
- FIG. 29 shows the cutting or incising device positioned within the sheath.
- FIG. 30 shows the cutting device positioned so that the cutting element will sweep around the tissue area being removed.
- FIG. 31 shows a tissue removal device introduced through another incision.
- FIG. 32 shows the tissue removal device attached to the tissue.
- FIG. 33-35 show use of the tissue cutting device to create a path for removing the tissue.
- FIG. 36 shows the cutting device used to penetrate the tissue to create a tissue removal incision.
- FIG. 37 shows the tissue contained within a tissue collection element having a tether which is coupled to the tissue cutter.
- FIG. 38 shows the tissue cutter removed with the tether extending from the excised tissue.
- FIG. 39 shows a side view of a tissue cutting device adjacent a tissue area to be removed.
- FIG. 40 shows the cutting element beginning to sweep around the tissue area.
- FIG. 41 shows the cutting element partially retracted to trap tissue between the cutting element and the shaft of the device.
- FIG. 42 shows the tissue cutting device marking the tissue.
- a needle 2 may be used to guide another medical device, such as a tissue cutting device 6 , when performing a procedure on the breast.
- a tissue cutting device 6 Any suitable tissue cutting device may be used such as the devices disclosed in U.S. Pat. Nos. 6,440,147 and 6,022,362 which are also hereby incorporated herein by reference.
- the tissue cutting device 6 has a cutting element 8 capable of assuming positions between collapsed and bowed positions. The tissue cutting device 6 is pivoted or rotated so that the cutting element 8 sweeps through and cuts the tissue along an arc.
- a tissue collection element 10 may also be provided which collects the tissue being cut.
- the needle 2 may also include a stiffener 4 which is used in the manner described in application Ser. No. 10/272,448, filed Oct. 16, 2002.
- the needle 2 may also have one or more indicators 14 to mark an angular position relative to the longitudinal axis 16 of the needle 2 .
- the indicator 14 extends radially outward from the needle at a angle selected by the user.
- the indicator 14 may also simply be a longitudinal stripe 18 or other marking on the shaft which indicates a particular angular orientation on the needle 2 .
- the indicator 14 may provide information to the user regarding various parameters depending upon the procedure being performed. For example, when using the device 6 described above, the angular position, or positions, provides the user with the angular extent of the tissue to be removed.
- the indicators 14 may be coupled to one more anchors 20 which are deployed to anchor the needle 2 .
- the anchor 20 is preferably curved, such as J- or C-shaped, and extends radially to lie within the same angular orientation as the indicator 14 .
- An advantage of coupling the indicator 14 to the anchor 20 is that anchor 20 itself provides information regarding the relative orientation or the needle 2 , anchor 20 and tissue area of interest. Thus, the anchor 20 itself may be one of the indicators 14 .
- the anchor 20 and indicator 14 are preferably aligned at the same angular orientation, they may also be offset to account for the geometry of other devices used with the needle 2 .
- the indicators 14 may also be independent of any anchoring elements.
- the needle 2 may be placed in the breast and the indicators 14 could then be moved to selected angular position(s).
- the needle 2 may also have depth markers 22 along the body.
- the anchor 20 is preferably a stainless steel wire having a sharpened tip to pierce through the tissue. The orientation of the anchor 20 is partially guided by the geometry of the arc-shaped lumens (not shown) receiving the anchors 20 .
- the needle 2 is introduced into the area of interest under suitable guidance such as ultrasound visualization. Once the needle 2 has been introduced in a desired or known orientation relative to the tissue area of interest, the entire needle 2 is rotated so that the first indicator 14 and marker 18 are aligned with a first angular position relative to the tissue area of interest. The first anchor 20 is then deployed into the tissue with the anchor 20 deployed at the selected angular orientation. The second indicator 14 is then rotated to a second selected angular orientation with respect to the area of interest.
- the second orientation is determined by visualizing the area of interest relative to the needle 2 and/or first anchor 20 to determine the appropriate location for the second anchor 20 .
- the second anchor 20 is then deployed by advancing the anchor into the tissue.
- the needle 2 and anchors 20 themselves provide visual landmarks for locating the area of interest.
- the markings on the needle 2 and the indicators 14 also help to guide use of the tissue cutting device 6 as described herein.
- the stiffener 4 is then removed to provide the flexible proximal portion.
- the flexible proximal portion may be taped to the patient to prevent inadvertent contact as shown in FIG. 7 .
- the flexible condition may be maintained to provide the benefit described above such as the ability to pull from varying angles as compared to a conventional rigid needle.
- the tissue removal device 6 may then be coupled to the needle 2 as shown in FIG. 8 and then advanced while being guided by the needle 2 .
- the needle 2 may be introduced to a predetermined depth where the longitudinal stop 38 guides the depth of introduction of the tissue removal device. Of course, the needle 2 may be introduced deeper into the tissue with the user using the depth markings 40 on the needle 2 and/or tissue removal device 6 to determine the appropriate introduction depth for the tissue removal device 6 .
- the cutting element 8 is then deployed to the bowed position and the cutting element 8 is swept through tissue to cut around the tissue area of interest.
- the tissue is then collected by the collection element 10 for removal.
- the device 6 is then withdrawn and anchors 30 , which are described in more detail in application Ser. No. 10/272,448, filed Oct. 16, 2002, are retracted to permit withdrawal of the needle 2 as well.
- FIG. 9 is a perspective view of a combination introducer and suction sleeve 902 .
- the sleeve 92 may be used in the same manner as the guide members described herein and such uses is expressly incorporated here.
- FIG. 10 is a side cross-sectional view thereof.
- the first external surface 904 of the combination introducer and suction sleeve 902 may have a generally tapered or funnel shape, in that it defines a relatively narrow diameter distal end and a relatively wider proximal end. Such a generally funnel or tapered shape eases the introduction of the device 802 within tissue.
- the combination introducer and suction sleeve 902 has a suction port 908 that opens to an internal lumen 916 defined by the internal surface 918 .
- the combination introducer and suction sleeve 902 also includes a second external surface 912 that defines a tapered appearance. Defined within the first and/or second external surfaces 904 , 912 are a plurality of openings 906 that open to the internal lumen 916 . In FIGS. 9-11 , only the first external surface 904 defines such openings 906 , although the openings are not limited to this surface.
- the suction port 908 is configured to couple with a vacuum line, as shown at 116 .
- the combination introducer and suction sleeve 902 may further include structures to couple to one or more devices.
- Such coupling structure(s) may include, for example, a snap or interference fitting 914 and/or one or more O-rings, such as shown at 910 .
- FIG. 11 is a perspective view of the combination introducer and suction sleeve of FIG. 9 , with a trocar 1102 inserted therein.
- the trocar 1102 may be inserted into the combination introducer and suction sleeve 902 and the assembly may be packaged as a (preferably single use) unit.
- a physician may utilize the assembly as follows:
- An incision into tissue is made with a blade
- the trocar 1102 may then be removed from the combination introducer and suction sleeve 902 and a desired (excisional RF, for example) device may then be inserted therethrough, with the shaft thereof disposed within and protruding from the internal lumen 916 ;
- the combination introducer and suction sleeve 902 may then be pulled back until it contacts, snaps and/or otherwise locks onto the device, as shown at FIGS. 12 and 13 .
- FIGS. 12 and 13 only the handle 102 of the device is shown, and the shaft 104 thereof is omitted for clarity of illustration. Examples of a tissue cutting device coupled to the combination introducer and suction sleeve 902 coupled thereto is shown in FIG. 14 ;
- a vacuum line such as shown at 116 , may then be attached to the suction port 908 ;
- the device with the combination introducer and suction sleeve 902 attached thereto may then be repositioned at, near, under or within the target lesion, as desired.
- This repositioning may be carried out under ultrasound guidance, for example.
- the openings 906 may aid with the ultrasound visualization.
- the combination may include other features and/or markings to increase the visibility thereof under various imaging modalities, and
- the physician may then continue with the intended procedure as per the instructions for use of the device utilized.
- the trocar 1102 may be removed from the combination introducer and suction sleeve 902 and the desired RF device introduced and locked therein.
- the distal tip of the desired RF device protruding from the distal end of the combination introducer and suction sleeve 902 may then be used to reach the intended biopsy site.
- a stopcock may be attached to the suction port 908 instead of the suction line 116 and one or more beneficial agents (e.g., antibiotics, fibrin, lidocaine) may be delivered to a target site through the openings 906 .
- beneficial agents e.g., antibiotics, fibrin, lidocaine
- the present combination vacuum sleeve and suction sleeve 902 may aid in positioning a biopsy or other interventional device where it is needed.
- interventional devices that include a rather bulky or high-drag distal end may be readily positioned at the intended site by means of the introducer functionality of the combination 902 .
- the combination 902 is advantageous before the biopsy or other interventional procedure is started by easing the positioning of the biopsy instrument at or near the target site, it is also useful during the procedure itself, as it is effective in evacuating hot gasses and fluids from the biopsy cavity, thereby decreasing collateral tissue thermal damage.
- the same combination may then also be used to treat the cavity post-procedure by, for example, providing a ready-made pathway for the introduction of beneficial agents, compositions and/or cavity treatment devices to the cavity or lesion site.
- a guide member 202 may be used to guide a cutting device 204 .
- the guide member 202 may be any of the suitable guide members described herein including the needle 2 of FIGS. 1-8 or the introducer 902 of FIGS. 9-14 .
- the cutting device 204 may be any of the cutting devices described herein or another suitable device such as those described in U.S. Pat. No. 7,044,956, issued May 16, 2006, which is hereby incorporated herein by reference in its entirety.
- the cutting device 204 has a cutting element 205 which bows outwardly when expanded.
- the guide member 202 has a tubular body 206 and a removable penetrating element 208 having a sharp tip 210 for piercing tissue during introduction.
- the guide member 202 also has a port 212 coupled to a vacuum source 214 for removing hot gasses generated during cutting.
- the penetrating element 208 has a shaft 216 extending through a lumen 217 in the guide member 202 .
- the guide member 202 may include one or more anchors 218 which holds the guide member 202 at the desired position.
- the anchor 218 may simply be an adhesive strip 220 which the user peels away from the body and adheres to the skin.
- the anchor 218 may also be another suitable anchor such as one or more needles 221 which are advanced into the tissue.
- the anchors 218 help to resist movement of the guide member 202 so that the guide member 220 may be used to guide longitudinal and even rotational positioning of the cutting device 204 as explained herein.
- the anchor 218 may also be a balloon 221 which is inflated to anchor the guide member.
- the guide member 202 may include a stop 222 which prevents further advancement of the tissue cutting device 202 so that the device 204 remains in the same longitudinal position.
- the guide member 202 may also include one or more angular indicators 224 which may be the anchors 218 .
- FIG. 19 another guide member 202 A is shown which has a window 226 oriented in the desired direction of cutting. The window 226 guides the user by limiting and/or defining the cutting motion to help guide the cutting procedure.
- the use and structural features of the guide member 220 , indicators 224 , anchors 118 and stop 222 may be the same or similar to those described in connection with FIGS. 1-8 .
- the cutting element 108 preferably has an ultrasound marker 232 at an anticipated apex of the cutting element 108 when the cutting element 108 is expanded to help position the device.
- the apex 232 does not necessarily correspond with the geometric middle of the cutting element 108 when the cutting element 108 is collapsed since only one end of the cutting element 108 may be moved to bow the cutting element 108 outward.
- the proximal end of the cutting element 108 may be advanced distally to bow the cutting element 108 outward in which case the first marker 232 would appear to be closer to the proximal end when the cutting element 108 is collapsed.
- the cutting device 204 may also include a second marker 234 and a third marker 236 which correspond to the ends of the cutting element 108 when the cutting element 108 is collapsed.
- the guide member 20 may have a first marker 229 , corresponding to an anticipated apex 229 of the cutting element 108 , and a second marker 228 and a third marker 230 corresponding to the ends 228 , 230 of the cutting element 108 when collapsed.
- the guide member 202 may help properly position the cutting device.
- any of the guide members or tissue cutting devices described herein, such as the needle 2 may also have the ultrasound markers positioned in this manner.
- the cutting element and the guide may be marked in any suitable manner.
- the cutting element or guide may include a hollow area which would enhance the ultrasound signature.
- the marker may be designed to be easily visible when the cutting element 205 is powered at a level lower than the power level used during cutting.
- the cutting element 205 may be designed to become more visible when an RF generator is switched to coagulation mode which has lower power than the cutting mode used when cutting tissue.
- the tissue cutting device 204 may have a shaft 240 with an asymmetrical cross-sectional shape adjacent to the cutting element 205 to aid parting off the tissue when completing the cutting operation.
- the shaft 240 is thicker in the direction in which the cutting element 205 expands as compared to the direction opposite cutter expansion. Stated another way, the shaft 240 may be thicker on a leading side 242 , which leads the cutting element when rotated in the direction of arrow 245 , than on an opposing or trailing side 244 .
- the shaft 240 may also be thicker on the leading side in a direction substantially perpendicular to expansion of the cutting element 205 A (shown mounted to shaft 240 in the dotted-line position).
- Cutting element 205 A is mounted to the shaft 240 in an orientation about 90 degrees from the orientation of the cutting element 205 .
- the cutting element 205 A may be mounted to the shaft 240 in other orientations relative to the thicker part of the shaft such as any position between element 205 and element 205 A.
- the cutting element 205 may be oriented and mounted on the shaft 240 in any manner which provides a thicker side within the first 90 degrees of the leading side compared to the shaft thickness in the 90 degrees trailing the cutting element 205 .
- the thicker part of the shaft 240 is preferably at least 1.25 times, 1.50 times, or even 1.75 times thicker than the thinner part of the shaft 240 .
- the shaft 240 may be formed in any suitable manner. Referring to FIGS. 20-24 , for example, a metallic tube 248 is cut to form a lip 250 which is bent outwardly to provide the thicker shaft section. The tube 248 is then covered with a shrink tube 252 and heated to bond the shrink tube 252 to the tube 248 . The shrink tube 252 covers the opening in the tube created by formation of the lip 252 . The shrink tube 252 also forms a beveled surface 254 which covers an opening 253 in the tube 248 created by the lip 250 .
- the guide member 202 is introduced into the tissue to an appropriate depth relative to the tissue to be removed.
- the guide member 202 may be used to help define and/or guide aspects of the cutting motion such as the depth of insertion and/or one or more angular positions indicating the angular extent of the targeted tissue.
- the ultrasound marker 229 may be used to position the guide member 202 so that the anticipated apex of the cutting element 205 is positioned appropriately.
- the cutting window 226 is positioned in the desired angular orientation which positions the tissue to be removed within the window 226 .
- the window 226 may have an opening a bit larger than the anticipated requirement so that the window 226 guides, but not necessarily overly limits, the angular and longitudinal position of the cutting device 204 .
- the tissue penetrating element 208 may be removed and the cutting device 204 is introduced into the guide member 202 .
- the guide member 202 is then retracted a predetermined amount so that the guide member 202 is properly positioned to remove hot gases generated during RF cutting as described above.
- the guide member does not, of course, need to be retracted.
- the cutting device 204 is then used to cut around the tissue to be removed.
- the tissue may be removed in a tissue collection element 10 (see FIG. 2 ).
- vacuum means may also be used to remove the tissue as now described and further described in application Ser. No. 10/796,328, filed Mar. 8, 2004.
- the cutting device 204 may be any suitable cutting device such as those described in U.S. Pat. No. 7,044,956, issued May 16, 2006.
- the core 400 has an active element 440 configured to perform intra-tissue imaging and of relaying information back to a display device (shown in FIG. 30 ) via a communication channel, such as shown at reference numeral 460 .
- the communication channel 460 may be wireless or may include, for example, optical fibers and/or electrical conductors.
- the active element 440 may draw power from an internal battery (not shown) or from a power source, such as shown at reference numeral 480 .
- the active element 440 may include an ultrasound transducer.
- the removable transducer core 400 preferably includes a generally tubular shaft 430 .
- a proximal section 450 is included near the proximal portion of the transducer core 400 .
- the excisional device 100 of FIG. 25 includes an internal lumen 420 through which the removable transducer core 400 may be inserted.
- the excisional device 100 is used once and disposed of, for safety and functional reasons.
- the removable transducer core 400 may either be disposable or re-usable for a limited number of uses.
- a generally tubular member 110 of the excisional device 100 includes a transducer window 410 .
- the proximal section 450 of the core 400 preferably snaps into a locked configuration with the proximal end of the excisional device 100 .
- the active element 440 of the transducer core 400 is aligned with and faces the transducer window 410 , to allow the active element 440 to image the lesion and the surrounding tissue therethrough.
- FIG. 26 shows an embodiment of the removable core 400 according to the present invention.
- the removable core 400 may advantageously be used independently of the excisional device 100 , the removable core 400 includes a distal tapered tip 470 , to allow it to easily penetrate soft tissue. Moreover, its thin profile allows the surgeon to insert the removable core 400 within soft tissue without, however, unduly damaging the tissue or making a large incision.
- the removable core 400 allows the surgeon to precisely localize the lesion to be excised from within the tissue itself.
- the active element 440 of the removable core 400 may include an ultrasound transducer and may be used alone or in addition to surface ultrasound to localize the lesion with a great degree of precision.
- FIG. 27 shows a cross section of the embodiment of the excisional device 100 of FIG. 25 , taken along line AA′.
- the cutting tool 125 is exposed through the transducer window 120 .
- the window 120 may, as shown in FIG. 27 , include support guides 122 to support and guide the cutting tool 125 as it is outwardly extended and bowed.
- the tissue collection device 260 for clarity, is not shown in either FIGS. 25 or 27 .
- the tubular member 110 may include a recessed section 131 .
- the recessed section provides space for the collected (e.g., bagged) tissue sample in the tissue collection device 260 when the excisional device is removed from the soft tissue mass.
- the collected tissue sample within the tissue collection device 260 does not protrude from the generally smooth outer surface of the excisional device 100 upon retraction of the latter from the soft tissue mass from which the tissue sample is excised.
- the internal lumen 420 allows the removable core 400 to slide therein and to properly position the active element 440 facing the transducer window 410 .
- FIG. 28 shows the removable core 400 inserted within the expandable sheath 495 .
- the expandable sheath 495 includes a proximal base section 510 .
- Attached to the proximal base section 510 is a generally cylindrical expandable meshwork 500 of, for example, plastic or nylon fibers.
- the meshwork 500 may be somewhat tapered at its distal end 520 , to provide a smooth transition between the expandable meshwork 500 and the removable core device 400 .
- the proximal section 450 of the core 400 may snap-fit to the proximal base section 510 of the expandable sheath 495 , so as to be securely and removably attached thereto. As shown in FIG.
- the expandable meshwork 500 expands just enough to accommodate the removable core 400 inserted therein.
- the expandable sheath 495 and removable core 400 assembly may be inserted within the soft tissue together, to allow the surgeon to image the lesion prior to inserting the somewhat greater diameter excisional device 100 therein. Thereafter, the surgeon may retract the removable core 400 from the expandable sheath 495 , leaving the expandable sheath 495 in place within the soft tissue, such as the breast.
- FIG. 29 shows another embodiment of a soft tissue excisional device assembly 600 according to the present invention.
- the removable core 400 is inserted and secured within the excisional device 100 so that the active element 440 faces out of the transducer window 410 .
- the excisional device 100 is removable from the expanded sheath 495 shown in FIG. 14 , while leaving the expanded sheath 495 in place within the soft tissue. In this manner, after retraction of the excisional device 100 from the sheath 495 , the sheath 495 remains in place within the soft tissue to allow other instruments to be inserted therethrough.
- the removable core 400 may, after the excisional procedure proper, be re-inserted through the expanded sheath 495 to the excision site.
- the tissue collection device 260 is not shown, for clarity but may be used in any manner described herein or in the applications or patents incorporated herein without departing from the scope of the invention.
- the excisional device 100 is shown inserted within the expandable sheath 495 .
- the excisional device 100 in FIG. 29 , is shown inserted within and past the distal end 520 of the meshwork 500 , so the distal portion of the excisional device 100 including the cutting element or tool 125 and the transducer window 410 extends therethrough.
- the meshwork 500 in FIG. 30 , has expanded to accommodate the diameter of the excisional device 100 .
- the proximal portion of the excisional device 100 may extend from the proximal base section of the expandable sheath 495 . This allows the push or turn knob 526 (a turn knob 526 shown in FIG. 29 ) to be manually accessible to the surgeon.
- a number of peripheral devices may be connected to the assembly 600 .
- a core power source 480 which may be, for example, an electrical source for an ultrasound transducer, one or more data processing and display devices 550 on which the internal structure of the tissue imaged by the active element 440 of the core 400 may be displayed, suction means 490 , a cutting tool power source (a variable RF energy source, for example or any suitable RF power source found in most operating rooms), and/or other devices 590 .
- the suction device 490 may provide a suction force to the window 120 through an internal lumen to facilitate cutting of the tissue by the cutting tool 125 . Any other suitable cutting or excisional device may be used in connection with the present invention such as those described in U.S. Pat. No. 7,044,956, issued May 16, 2006.
- the vacuum means may be associated with the cutting tool 125 ( FIG. 25 ) or the cutting device 204 ( FIG. 17 ) or may be a separate removal device 300 as shown in FIG. 30 .
- the tissue may also be removed through the same incision or a separate incision from the incision through which the cutting device 204 extends.
- the tissue removal device 300 may have one or more suction ports 302 at a distal end 308 .
- the suction port 302 is coupled to a lumen 304 which in turn is coupled to a vacuum source 306 .
- the suction port 302 can be flared outwardly to enhance suction adherence and to help retract tissue away from the tissue being removed as shown in FIG. 32 .
- the end 308 may have longitudinal slots (not shown) covered by an elastic cover 309 which permits the end 308 to flare outwardly in a manner similar to expandable trocars and cannulae as is known in the art.
- the end 308 may be actuated with a thumb switch 310 or other suitable actuator.
- the tissue removal device 300 may also directly grasp or pierce the tissue with piercing elements 311 , such as needles 313 , rather than relying on suction adherence.
- the tissue removal device 300 may advance needles 312 into the tissue to anchor and grasp the tissue.
- the tissue removal device 300 may be introduced through the same incision as the tissue cutting device 204 or may be introduced through a different incision.
- the user may choose to introduce the cutting device 204 based primarily on the desired orientation of the cutting device 200 relative to the tissue area being removed.
- the user may then choose the removal incision based on other factors such as proximity to the skin or for cosmetic considerations.
- the removal incision may be partially or completely created with the tissue cutting device 204 .
- the cutting element 205 may be expanded and energized when the shaft is being withdrawn and/or advanced so that the cutting element 205 creates a tissue channel. This procedure may be repeated to create the desired channel such as an X- or Y-shaped channel.
- the cutting element 205 may have a movable insulating sheath 260 which covers a portion of the cutting element 205 , such as the distal portion of the element 205 , to prevent inadvertent cutting of the tissue being removed when creating the tissue channel.
- a movable insulating sleeve 260 is described in U.S. Pat. No. 7,198,626, issued Apr. 3, 2007, which is hereby incorporated herein by reference in its entirety.
- the cutting element 205 may also be used to create a separate incision for removal of the tissue by cutting a channel directly from the area in which the tissue has been cut and extending outwardly from the severed portion.
- the cutting element 205 is positioned so that further extension and bowing of the cutting element 205 will essentially create a path outwardly from the severed portion of the tissue. This procedure may be performed after severing the tissue in this area so that the cutting element 205 can be initially positioned without RF power.
- the ultrasound markers described herein, and in particular the marker near the apex of the cutting element 205 when expanded and bowed, are particularly useful in properly positioning the cutting element 205 at this time.
- the cutting element 205 may then be powered with RF to partially or completely create the tissue channel. This procedure may be desirable when the cutting procedure causes the cutting element 205 to pass near the skin.
- the cutting device 204 may also include a movable insulating sleeve 261 which covers part of the cutting element 205 , such as portions on the ends of the cutting element 205 , during this part of the procedure to reduce the excess lateral cutting during creation of the tissue channel.
- the tissue When removing the tissue, the tissue may be contained within a tissue collection element 320 released by the cutting device 204 when the tissue is severed or which is deployed by itself after excision of the tissue.
- the tissue collection element 320 may simply trail the cutting element 205 similar to the patents and applications incorporated by reference herein in which the tissue collection element remains coupled to the device.
- FIG. 37 shows the collection element 320 containing the tissue with a tether 322 extending from the tissue collection element 320 and being withdrawn as the cutting device 204 is removed.
- the tether 322 may be used to guide advancement and engagement of the tissue removal device 300 .
- the tissue collection element 320 may have a connector 324 which engages the removal device 300 with a suitable mechanical, magnetic or suction connection.
- the connector 324 may be positioned at the end of the tether 322 so that engagement with the connector 324 is easily guided by the tether 322 .
- the tether 322 may be particularly useful when removing the tissue through a separate incision since the tether 322 can be easily retrieved using a conventional suture snare or the like.
- the tether 322 may also be used without the tissue collection element 320 by simply attaching the tether 320 to the tissue with a needle, screw 321 (see FIG. 37 ) or other suitable attachment feature.
- the tether 320 may be delivered by the cutting device 204 or may be part of another device such as the tissue removal devices described herein.
- the tissue cutting device 204 is shown and all features and aspects of the tissue cutting devices described herein are incorporated here.
- the tissue cutting device 204 is shown sweeping around the tissue to be removed.
- the cutting element 205 is then partially retracted so that only a small piece of tissue connects the tissue to be removed from the surrounding tissue as shown in FIG. 41 .
- the tissue cutting device 205 may then be used to manipulate the tissue to assist or prepare the tissue for removal.
- the tissue cutting device 204 may be designed to lock the cutting element 205 in the partially opened position of FIG. 41 to trap the tissue between the cutting element 205 and the shaft 240 so that the cutting device 204 may be used to manipulate the tissue.
- the tissue may be manipulated while the tissue is being encapsulated in a tissue collection element or when the tissue is being engaged by any of the tissue removal devices described herein such as the device 300 .
- the cutting element 205 is collapsed further to complete the cut.
- the tissue cutting device 204 may also mark the tissue sample and/or the tissue surrounding the tissue sample as shown in FIG. 42 . Marking the tissue may assist in identifying the tissue for removal or to mark the tissue remaining in the body for subsequent therapy or treatment.
- the tissue may be marked in any suitable manner such as those described in application Ser. No. 10/871,790, filed Jun. 17, 2004, which is hereby incorporated herein by reference in its entirety.
- the tissue cutting device 204 may have one or more dye injection ports 330 to mark the tissue.
- the cutting device may also leave behind a marker, such as a spiral spring or coil as described above, to mark the tissue rather than marking the tissue with a dye or the like. It is understood that marking the tissue being removed and/or marking the tissue remaining in the body may be used in connection with any of the other features and aspects of the present invention including use with any of the tissue cutting or removal devices described herein.
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Abstract
Description
- 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. §119(e) and §120.
- 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. - 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.
- 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.
- 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.
- 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.
- 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.
- In one aspect of the present invention, a method of removing breast tissue, may include steps of providing a tissue cutting device having a shaft, a tissue collection element 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; positioning the tissue cut by the cutting element into the tissue collection element; and removing the tissue collection element through a second incision different from the first incision.
- The removing step may be carried out with a removal device extending through the second incision, the removal step including the step of coupling the removal device to the tissue collection element. The removing step may be carried out with the removal device having a distal end movable between a collapsed position and an expanded position, the expanded position being flared outwardly. The removing step may be carried out with the removal device having a suction opening coupled to a vacuum source, the removal device adhering to the tissue collection element with the suction opening.
- These and other aspects of the present invention will become apparent from the following drawings and description.
-
FIG. 1 shows a needle made in accordance with the present invention. -
FIG. 2 shows a tissue removing device. -
FIG. 3 shows the needle introduced into a breast. -
FIG. 4 shows a first anchor deployed within the breast. -
FIG. 5 shows a second anchor deployed within the breast. -
FIG. 6 shows a stiffener removed to provide a flexible proximal end. -
FIG. 7 shows the flexible, proximal portion taped to the breast. -
FIG. 8 shows a tissue removing device advanced over the needle and a cutting element deployed. -
FIG. 9 is a perspective view of a combination introducer and suction sleeve, according to another embodiment of the present invention. -
FIG. 10 is a side cross-sectional view of the combination introducer and suction sleeve ofFIG. 9 . -
FIG. 11 is a perspective view of the combination introducer and suction sleeve ofFIG. 9 , with a trocar inserted therein. -
FIG. 12 is a side cross-sectional view of the combination introducer and suction sleeve ofFIG. 9 , illustrating exemplary structure with which the suction sleeve may attach to the interventional device. -
FIG. 13 is a perspective cross-sectional view of the combination introducer and suction sleeve, attached to an exemplary interventional device -
FIG. 14 is a perspective view of another embodiment of a suction sleeve according to the present invention, coupled to an exemplary interventional device. -
FIG. 15 shows another guide element used to introduced a cutting device into the tissue. -
FIG. 16 shows a piercing element removed from a lumen in the guide member. -
FIG. 17 shows a cutting device introduced into the guide element. -
FIG. 18 shows guide member retracted and anchored to the tissue with needles and an adhesive tape. -
FIG. 19 shows a perspective view of another guide member having a window through which the cutting element extends when cutting the tissue. -
FIG. 20 shows a tube which is cut to form a lip. -
FIG. 21 is a cross-sectional view ofFIG. 21 along line I-I. -
FIG. 22 shows the tube ofFIG. 21 covered with a shrink tube. -
FIG. 23 is a cross-sectional view ofFIG. 23 along line II-II with the addition of a cutting element shown in an expanded or bowed configuration. -
FIG. 24 is a cross-sectional view ofFIG. 23 along line III-III. -
FIG. 25 shows another device for cutting or incising tissue. -
FIG. 26 shows a removable core. -
FIG. 27 is a cross-sectional view of the device ofFIG. 26 along line A-A. -
FIG. 28 shows the removable core positioned within a sheath. -
FIG. 29 shows the cutting or incising device positioned within the sheath. -
FIG. 30 shows the cutting device positioned so that the cutting element will sweep around the tissue area being removed. -
FIG. 31 shows a tissue removal device introduced through another incision. -
FIG. 32 shows the tissue removal device attached to the tissue. -
FIG. 33-35 show use of the tissue cutting device to create a path for removing the tissue. -
FIG. 36 shows the cutting device used to penetrate the tissue to create a tissue removal incision. -
FIG. 37 shows the tissue contained within a tissue collection element having a tether which is coupled to the tissue cutter. -
FIG. 38 shows the tissue cutter removed with the tether extending from the excised tissue. -
FIG. 39 shows a side view of a tissue cutting device adjacent a tissue area to be removed. -
FIG. 40 shows the cutting element beginning to sweep around the tissue area. -
FIG. 41 shows the cutting element partially retracted to trap tissue between the cutting element and the shaft of the device. -
FIG. 42 shows the tissue cutting device marking the tissue. - Referring to
FIGS. 1-8 , aneedle 2 may be used to guide another medical device, such as atissue cutting device 6, when performing a procedure on the breast. Any suitable tissue cutting device may be used such as the devices disclosed in U.S. Pat. Nos. 6,440,147 and 6,022,362 which are also hereby incorporated herein by reference. Thetissue cutting device 6 has acutting element 8 capable of assuming positions between collapsed and bowed positions. Thetissue cutting device 6 is pivoted or rotated so that the cuttingelement 8 sweeps through and cuts the tissue along an arc. Atissue collection element 10 may also be provided which collects the tissue being cut. Theneedle 2 may also include astiffener 4 which is used in the manner described in application Ser. No. 10/272,448, filed Oct. 16, 2002. - The
needle 2 may also have one ormore indicators 14 to mark an angular position relative to the longitudinal axis 16 of theneedle 2. Theindicator 14 extends radially outward from the needle at a angle selected by the user. Theindicator 14 may also simply be alongitudinal stripe 18 or other marking on the shaft which indicates a particular angular orientation on theneedle 2. Theindicator 14 may provide information to the user regarding various parameters depending upon the procedure being performed. For example, when using thedevice 6 described above, the angular position, or positions, provides the user with the angular extent of the tissue to be removed. - The
indicators 14 may be coupled to one more anchors 20 which are deployed to anchor theneedle 2. Theanchor 20 is preferably curved, such as J- or C-shaped, and extends radially to lie within the same angular orientation as theindicator 14. An advantage of coupling theindicator 14 to theanchor 20 is thatanchor 20 itself provides information regarding the relative orientation or theneedle 2,anchor 20 and tissue area of interest. Thus, theanchor 20 itself may be one of theindicators 14. Although theanchor 20 andindicator 14 are preferably aligned at the same angular orientation, they may also be offset to account for the geometry of other devices used with theneedle 2. As can be appreciated, of course, theindicators 14 may also be independent of any anchoring elements. For example, theneedle 2 may be placed in the breast and theindicators 14 could then be moved to selected angular position(s). Theneedle 2 may also havedepth markers 22 along the body. Theanchor 20 is preferably a stainless steel wire having a sharpened tip to pierce through the tissue. The orientation of theanchor 20 is partially guided by the geometry of the arc-shaped lumens (not shown) receiving theanchors 20. - Use of the device is now described in connection with a tissue removal procedure with reference to
FIGS. 1-8 . Of course, other procedures may be performed without departing from the scope of the invention. Theneedle 2 is introduced into the area of interest under suitable guidance such as ultrasound visualization. Once theneedle 2 has been introduced in a desired or known orientation relative to the tissue area of interest, theentire needle 2 is rotated so that thefirst indicator 14 andmarker 18 are aligned with a first angular position relative to the tissue area of interest. Thefirst anchor 20 is then deployed into the tissue with theanchor 20 deployed at the selected angular orientation. Thesecond indicator 14 is then rotated to a second selected angular orientation with respect to the area of interest. The second orientation is determined by visualizing the area of interest relative to theneedle 2 and/orfirst anchor 20 to determine the appropriate location for thesecond anchor 20. Thesecond anchor 20 is then deployed by advancing the anchor into the tissue. As can be appreciated, theneedle 2 and anchors 20 themselves provide visual landmarks for locating the area of interest. The markings on theneedle 2 and theindicators 14 also help to guide use of thetissue cutting device 6 as described herein. - The
stiffener 4 is then removed to provide the flexible proximal portion. The flexible proximal portion may be taped to the patient to prevent inadvertent contact as shown inFIG. 7 . When performing the procedure, the flexible condition may be maintained to provide the benefit described above such as the ability to pull from varying angles as compared to a conventional rigid needle. Thetissue removal device 6 may then be coupled to theneedle 2 as shown inFIG. 8 and then advanced while being guided by theneedle 2. Theneedle 2 may be introduced to a predetermined depth where thelongitudinal stop 38 guides the depth of introduction of the tissue removal device. Of course, theneedle 2 may be introduced deeper into the tissue with the user using thedepth markings 40 on theneedle 2 and/ortissue removal device 6 to determine the appropriate introduction depth for thetissue removal device 6. The cuttingelement 8 is then deployed to the bowed position and the cuttingelement 8 is swept through tissue to cut around the tissue area of interest. The tissue is then collected by thecollection element 10 for removal. Thedevice 6 is then withdrawn and anchors 30, which are described in more detail in application Ser. No. 10/272,448, filed Oct. 16, 2002, are retracted to permit withdrawal of theneedle 2 as well. -
FIG. 9 is a perspective view of a combination introducer andsuction sleeve 902. The sleeve 92 may be used in the same manner as the guide members described herein and such uses is expressly incorporated here.FIG. 10 is a side cross-sectional view thereof. Considering nowFIGS. 9 and 10 collectively, the firstexternal surface 904 of the combination introducer andsuction sleeve 902 may have a generally tapered or funnel shape, in that it defines a relatively narrow diameter distal end and a relatively wider proximal end. Such a generally funnel or tapered shape eases the introduction of the device 802 within tissue. The combination introducer andsuction sleeve 902 has asuction port 908 that opens to aninternal lumen 916 defined by theinternal surface 918. The combination introducer andsuction sleeve 902 also includes a secondexternal surface 912 that defines a tapered appearance. Defined within the first and/or secondexternal surfaces openings 906 that open to theinternal lumen 916. InFIGS. 9-11 , only the firstexternal surface 904 definessuch openings 906, although the openings are not limited to this surface. Thesuction port 908 is configured to couple with a vacuum line, as shown at 116. The combination introducer andsuction sleeve 902 may further include structures to couple to one or more devices. Such coupling structure(s) may include, for example, a snap or interference fitting 914 and/or one or more O-rings, such as shown at 910. -
FIG. 11 is a perspective view of the combination introducer and suction sleeve ofFIG. 9 , with atrocar 1102 inserted therein. According to an embodiment of the present invention, thetrocar 1102 may be inserted into the combination introducer andsuction sleeve 902 and the assembly may be packaged as a (preferably single use) unit. According to another embodiment of the present invention, a physician may utilize the assembly as follows: - An incision into tissue is made with a blade;
- The physician then inserts the assembly including the
trocar 1102 into the tissue and pushes the combination introducer andsuction sleeve 902 into the tissue through the incision into position under or near the lesion or targeted site within the tissue. The pointed and/or sharpdistal tip 1104 of thetrocar 1102 and the tapered profile of the combination introducer andsuction sleeve 902 aid the assembly's advancement within the tissue; - The
trocar 1102 may then be removed from the combination introducer andsuction sleeve 902 and a desired (excisional RF, for example) device may then be inserted therethrough, with the shaft thereof disposed within and protruding from theinternal lumen 916; - The combination introducer and
suction sleeve 902 may then be pulled back until it contacts, snaps and/or otherwise locks onto the device, as shown atFIGS. 12 and 13 . InFIGS. 12 and 13 , only thehandle 102 of the device is shown, and theshaft 104 thereof is omitted for clarity of illustration. Examples of a tissue cutting device coupled to the combination introducer andsuction sleeve 902 coupled thereto is shown inFIG. 14 ; - A vacuum line, such as shown at 116, may then be attached to the
suction port 908; - If needed, the device with the combination introducer and
suction sleeve 902 attached thereto may then be repositioned at, near, under or within the target lesion, as desired. This repositioning may be carried out under ultrasound guidance, for example. Theopenings 906 may aid with the ultrasound visualization. The combination may include other features and/or markings to increase the visibility thereof under various imaging modalities, and - The physician may then continue with the intended procedure as per the instructions for use of the device utilized.
- Alternatively, the
trocar 1102 may be removed from the combination introducer andsuction sleeve 902 and the desired RF device introduced and locked therein. The distal tip of the desired RF device protruding from the distal end of the combination introducer andsuction sleeve 902 may then be used to reach the intended biopsy site. - Alternately still, a stopcock may be attached to the
suction port 908 instead of thesuction line 116 and one or more beneficial agents (e.g., antibiotics, fibrin, lidocaine) may be delivered to a target site through theopenings 906. - The present combination vacuum sleeve and
suction sleeve 902 may aid in positioning a biopsy or other interventional device where it is needed. For example, interventional devices that include a rather bulky or high-drag distal end may be readily positioned at the intended site by means of the introducer functionality of thecombination 902. While thecombination 902 is advantageous before the biopsy or other interventional procedure is started by easing the positioning of the biopsy instrument at or near the target site, it is also useful during the procedure itself, as it is effective in evacuating hot gasses and fluids from the biopsy cavity, thereby decreasing collateral tissue thermal damage. The same combination may then also be used to treat the cavity post-procedure by, for example, providing a ready-made pathway for the introduction of beneficial agents, compositions and/or cavity treatment devices to the cavity or lesion site. - Referring now to
FIGS. 15-18 , anothersystem 200 and method are shown wherein the same or similar reference numbers refer to the same or similar structure. As mentioned above, aguide member 202 may be used to guide acutting device 204. Theguide member 202 may be any of the suitable guide members described herein including theneedle 2 ofFIGS. 1-8 or theintroducer 902 ofFIGS. 9-14 . Thecutting device 204 may be any of the cutting devices described herein or another suitable device such as those described in U.S. Pat. No. 7,044,956, issued May 16, 2006, which is hereby incorporated herein by reference in its entirety. Thecutting device 204 has acutting element 205 which bows outwardly when expanded. - The
guide member 202 has atubular body 206 and a removablepenetrating element 208 having asharp tip 210 for piercing tissue during introduction. Theguide member 202 also has aport 212 coupled to avacuum source 214 for removing hot gasses generated during cutting. The penetratingelement 208 has ashaft 216 extending through alumen 217 in theguide member 202. Theguide member 202 may include one ormore anchors 218 which holds theguide member 202 at the desired position. Theanchor 218 may simply be anadhesive strip 220 which the user peels away from the body and adheres to the skin. Theanchor 218 may also be another suitable anchor such as one ormore needles 221 which are advanced into the tissue. Theanchors 218 help to resist movement of theguide member 202 so that theguide member 220 may be used to guide longitudinal and even rotational positioning of thecutting device 204 as explained herein. Referring toFIG. 19 , theanchor 218 may also be aballoon 221 which is inflated to anchor the guide member. - After the
guide member 202 has been introduced to the desired depth, the penetratingelement 208 is then removed and thetissue cutting device 204 is introduced and advanced into the guide member 220 (FIG. 17 ). Theguide member 202 may include astop 222 which prevents further advancement of thetissue cutting device 202 so that thedevice 204 remains in the same longitudinal position. Theguide member 202 may also include one or moreangular indicators 224 which may be theanchors 218. Referring toFIG. 19 , anotherguide member 202A is shown which has awindow 226 oriented in the desired direction of cutting. Thewindow 226 guides the user by limiting and/or defining the cutting motion to help guide the cutting procedure. The use and structural features of theguide member 220,indicators 224, anchors 118 and stop 222 may be the same or similar to those described in connection withFIGS. 1-8 . - Referring again to
FIG. 14 , the cuttingelement 108 preferably has anultrasound marker 232 at an anticipated apex of the cuttingelement 108 when the cuttingelement 108 is expanded to help position the device. The apex 232 does not necessarily correspond with the geometric middle of the cuttingelement 108 when the cuttingelement 108 is collapsed since only one end of the cuttingelement 108 may be moved to bow thecutting element 108 outward. For example, the proximal end of the cuttingelement 108 may be advanced distally to bow thecutting element 108 outward in which case thefirst marker 232 would appear to be closer to the proximal end when the cuttingelement 108 is collapsed. Thecutting device 204 may also include asecond marker 234 and athird marker 236 which correspond to the ends of the cuttingelement 108 when the cuttingelement 108 is collapsed. Referring again toFIG. 17 , theguide member 20 may have afirst marker 229, corresponding to ananticipated apex 229 of the cuttingelement 108, and asecond marker 228 and a third marker 230 corresponding to theends 228, 230 of the cuttingelement 108 when collapsed. In this manner, theguide member 202 may help properly position the cutting device. Of course, any of the guide members or tissue cutting devices described herein, such as theneedle 2, may also have the ultrasound markers positioned in this manner. The cutting element and the guide may be marked in any suitable manner. For example, the cutting element or guide may include a hollow area which would enhance the ultrasound signature. When placing a marker on the cutting element, the marker may be designed to be easily visible when the cuttingelement 205 is powered at a level lower than the power level used during cutting. For example, the cuttingelement 205 may be designed to become more visible when an RF generator is switched to coagulation mode which has lower power than the cutting mode used when cutting tissue. - Referring now to
FIGS. 20-24 , thetissue cutting device 204 may have ashaft 240 with an asymmetrical cross-sectional shape adjacent to thecutting element 205 to aid parting off the tissue when completing the cutting operation. Theshaft 240 is thicker in the direction in which thecutting element 205 expands as compared to the direction opposite cutter expansion. Stated another way, theshaft 240 may be thicker on aleading side 242, which leads the cutting element when rotated in the direction ofarrow 245, than on an opposing or trailingside 244. Theshaft 240 may also be thicker on the leading side in a direction substantially perpendicular to expansion of the cuttingelement 205A (shown mounted toshaft 240 in the dotted-line position). Cuttingelement 205A is mounted to theshaft 240 in an orientation about 90 degrees from the orientation of the cuttingelement 205. Of course, the cuttingelement 205A may be mounted to theshaft 240 in other orientations relative to the thicker part of the shaft such as any position betweenelement 205 andelement 205A. Stated still another way, the cuttingelement 205 may be oriented and mounted on theshaft 240 in any manner which provides a thicker side within the first 90 degrees of the leading side compared to the shaft thickness in the 90 degrees trailing the cuttingelement 205. In the various suggested configurations described, the thicker part of theshaft 240 is preferably at least 1.25 times, 1.50 times, or even 1.75 times thicker than the thinner part of theshaft 240. - The
shaft 240 may be formed in any suitable manner. Referring toFIGS. 20-24 , for example, ametallic tube 248 is cut to form alip 250 which is bent outwardly to provide the thicker shaft section. Thetube 248 is then covered with ashrink tube 252 and heated to bond theshrink tube 252 to thetube 248. Theshrink tube 252 covers the opening in the tube created by formation of thelip 252. Theshrink tube 252 also forms abeveled surface 254 which covers anopening 253 in thetube 248 created by thelip 250. - Use of the
system 200 is now described with reference again toFIGS. 15-19 . Theguide member 202 is introduced into the tissue to an appropriate depth relative to the tissue to be removed. As explained above, theguide member 202 may be used to help define and/or guide aspects of the cutting motion such as the depth of insertion and/or one or more angular positions indicating the angular extent of the targeted tissue. For example, theultrasound marker 229 may be used to position theguide member 202 so that the anticipated apex of the cuttingelement 205 is positioned appropriately. When theguide member 202A ofFIG. 19 is used, the cuttingwindow 226 is positioned in the desired angular orientation which positions the tissue to be removed within thewindow 226. Thewindow 226 may have an opening a bit larger than the anticipated requirement so that thewindow 226 guides, but not necessarily overly limits, the angular and longitudinal position of thecutting device 204. - Once the
guide member tissue penetrating element 208 may be removed and thecutting device 204 is introduced into theguide member 202. Theguide member 202 is then retracted a predetermined amount so that theguide member 202 is properly positioned to remove hot gases generated during RF cutting as described above. When using theguide member 202A having the cuttingwindow 226, the guide member does not, of course, need to be retracted. - The
cutting device 204 is then used to cut around the tissue to be removed. The tissue may be removed in a tissue collection element 10 (seeFIG. 2 ). Alternatively, vacuum means may also be used to remove the tissue as now described and further described in application Ser. No. 10/796,328, filed Mar. 8, 2004. Thecutting device 204 may be any suitable cutting device such as those described in U.S. Pat. No. 7,044,956, issued May 16, 2006. - Referring now to
FIGS. 25-29 , another system is shown which uses asheath 495 to receive one or more devices such as acore 400, which may be used for imaging, and anexcisional device 100 which is used to cut the tissue. Thecore 400 has anactive element 440 configured to perform intra-tissue imaging and of relaying information back to a display device (shown inFIG. 30 ) via a communication channel, such as shown atreference numeral 460. Thecommunication channel 460 may be wireless or may include, for example, optical fibers and/or electrical conductors. Theactive element 440 may draw power from an internal battery (not shown) or from a power source, such as shown atreference numeral 480. Theactive element 440 may include an ultrasound transducer. Other types of transducers may be used instead of or in addition to an ultrasound transducer. Theremovable transducer core 400 preferably includes a generallytubular shaft 430. Aproximal section 450 is included near the proximal portion of thetransducer core 400. - To accommodate the
removable transducer core 400, theexcisional device 100 ofFIG. 25 includes aninternal lumen 420 through which theremovable transducer core 400 may be inserted. Preferably, theexcisional device 100 is used once and disposed of, for safety and functional reasons. Theremovable transducer core 400, however, may either be disposable or re-usable for a limited number of uses. To allow theactive element 440 of thetransducer core 400 to image the lesion to be excised and the surrounding tissue, a generallytubular member 110 of theexcisional device 100 includes atransducer window 410. When theremovable transducer core 400 is inserted within theinternal lumen 420, theproximal section 450 of the core 400 preferably snaps into a locked configuration with the proximal end of theexcisional device 100. When in its locked configuration, theactive element 440 of thetransducer core 400 is aligned with and faces thetransducer window 410, to allow theactive element 440 to image the lesion and the surrounding tissue therethrough. -
FIG. 26 shows an embodiment of theremovable core 400 according to the present invention. As theremovable core 400 may advantageously be used independently of theexcisional device 100, theremovable core 400 includes a distal taperedtip 470, to allow it to easily penetrate soft tissue. Moreover, its thin profile allows the surgeon to insert theremovable core 400 within soft tissue without, however, unduly damaging the tissue or making a large incision. Theremovable core 400 allows the surgeon to precisely localize the lesion to be excised from within the tissue itself. For example, theactive element 440 of theremovable core 400 may include an ultrasound transducer and may be used alone or in addition to surface ultrasound to localize the lesion with a great degree of precision. -
FIG. 27 shows a cross section of the embodiment of theexcisional device 100 ofFIG. 25 , taken along line AA′. As shown inFIG. 27 , thecutting tool 125 is exposed through thetransducer window 120. Thewindow 120 may, as shown inFIG. 27 , include support guides 122 to support and guide thecutting tool 125 as it is outwardly extended and bowed. Thetissue collection device 260, for clarity, is not shown in either FIGS. 25 or 27. However, to accommodate the bulk of the excised tissue sample collected in thetissue collection device 260 after the cutting and collecting operation described herein, thetubular member 110 may include a recessedsection 131. The recessed section provides space for the collected (e.g., bagged) tissue sample in thetissue collection device 260 when the excisional device is removed from the soft tissue mass. In this manner, the collected tissue sample within thetissue collection device 260 does not protrude from the generally smooth outer surface of theexcisional device 100 upon retraction of the latter from the soft tissue mass from which the tissue sample is excised. Theinternal lumen 420 allows theremovable core 400 to slide therein and to properly position theactive element 440 facing thetransducer window 410. -
FIG. 28 shows theremovable core 400 inserted within theexpandable sheath 495. Theexpandable sheath 495 includes aproximal base section 510. Attached to theproximal base section 510 is a generally cylindricalexpandable meshwork 500 of, for example, plastic or nylon fibers. Themeshwork 500 may be somewhat tapered at itsdistal end 520, to provide a smooth transition between theexpandable meshwork 500 and theremovable core device 400. Theproximal section 450 of thecore 400 may snap-fit to theproximal base section 510 of theexpandable sheath 495, so as to be securely and removably attached thereto. As shown inFIG. 28 , theexpandable meshwork 500 expands just enough to accommodate theremovable core 400 inserted therein. In practice, theexpandable sheath 495 andremovable core 400 assembly may be inserted within the soft tissue together, to allow the surgeon to image the lesion prior to inserting the somewhat greater diameterexcisional device 100 therein. Thereafter, the surgeon may retract theremovable core 400 from theexpandable sheath 495, leaving theexpandable sheath 495 in place within the soft tissue, such as the breast. -
FIG. 29 shows another embodiment of a soft tissueexcisional device assembly 600 according to the present invention. In the configuration shown inFIG. 29 , theremovable core 400 is inserted and secured within theexcisional device 100 so that theactive element 440 faces out of thetransducer window 410. Preferably, theexcisional device 100 is removable from the expandedsheath 495 shown inFIG. 14 , while leaving the expandedsheath 495 in place within the soft tissue. In this manner, after retraction of theexcisional device 100 from thesheath 495, thesheath 495 remains in place within the soft tissue to allow other instruments to be inserted therethrough. For example, theremovable core 400 may, after the excisional procedure proper, be re-inserted through the expandedsheath 495 to the excision site. Thetissue collection device 260 is not shown, for clarity but may be used in any manner described herein or in the applications or patents incorporated herein without departing from the scope of the invention. - In
FIG. 29 , theexcisional device 100 is shown inserted within theexpandable sheath 495. Indeed, theexcisional device 100, inFIG. 29 , is shown inserted within and past thedistal end 520 of themeshwork 500, so the distal portion of theexcisional device 100 including the cutting element ortool 125 and thetransducer window 410 extends therethrough. Themeshwork 500, inFIG. 30 , has expanded to accommodate the diameter of theexcisional device 100. The proximal portion of theexcisional device 100 may extend from the proximal base section of theexpandable sheath 495. This allows the push or turn knob 526 (aturn knob 526 shown inFIG. 29 ) to be manually accessible to the surgeon. - A number of peripheral devices may be connected to the
assembly 600. Examples of such include acore power source 480, which may be, for example, an electrical source for an ultrasound transducer, one or more data processing anddisplay devices 550 on which the internal structure of the tissue imaged by theactive element 440 of thecore 400 may be displayed, suction means 490, a cutting tool power source (a variable RF energy source, for example or any suitable RF power source found in most operating rooms), and/or other devices 590. Thesuction device 490 may provide a suction force to thewindow 120 through an internal lumen to facilitate cutting of the tissue by thecutting tool 125. Any other suitable cutting or excisional device may be used in connection with the present invention such as those described in U.S. Pat. No. 7,044,956, issued May 16, 2006. - The vacuum means may be associated with the cutting tool 125 (
FIG. 25 ) or the cutting device 204 (FIG. 17 ) or may be aseparate removal device 300 as shown inFIG. 30 . As will be further described, the tissue may also be removed through the same incision or a separate incision from the incision through which thecutting device 204 extends. Referring still toFIG. 31 , thetissue removal device 300 may have one ormore suction ports 302 at a distal end 308. Thesuction port 302 is coupled to alumen 304 which in turn is coupled to avacuum source 306. Thesuction port 302 can be flared outwardly to enhance suction adherence and to help retract tissue away from the tissue being removed as shown inFIG. 32 . The end 308 may have longitudinal slots (not shown) covered by anelastic cover 309 which permits the end 308 to flare outwardly in a manner similar to expandable trocars and cannulae as is known in the art. The end 308 may be actuated with athumb switch 310 or other suitable actuator. Of course, thetissue removal device 300 may also directly grasp or pierce the tissue with piercingelements 311, such asneedles 313, rather than relying on suction adherence. For example, thetissue removal device 300 may advance needles 312 into the tissue to anchor and grasp the tissue. - The
tissue removal device 300 may be introduced through the same incision as thetissue cutting device 204 or may be introduced through a different incision. For example, the user may choose to introduce thecutting device 204 based primarily on the desired orientation of thecutting device 200 relative to the tissue area being removed. The user may then choose the removal incision based on other factors such as proximity to the skin or for cosmetic considerations. Referring toFIGS. 33-35 , the removal incision may be partially or completely created with thetissue cutting device 204. For example, the cuttingelement 205 may be expanded and energized when the shaft is being withdrawn and/or advanced so that the cuttingelement 205 creates a tissue channel. This procedure may be repeated to create the desired channel such as an X- or Y-shaped channel. The cuttingelement 205 may have a movable insulatingsheath 260 which covers a portion of the cuttingelement 205, such as the distal portion of theelement 205, to prevent inadvertent cutting of the tissue being removed when creating the tissue channel. Use of a movableinsulating sleeve 260 is described in U.S. Pat. No. 7,198,626, issued Apr. 3, 2007, which is hereby incorporated herein by reference in its entirety. - Referring to
FIG. 36 , the cuttingelement 205 may also be used to create a separate incision for removal of the tissue by cutting a channel directly from the area in which the tissue has been cut and extending outwardly from the severed portion. The cuttingelement 205 is positioned so that further extension and bowing of the cuttingelement 205 will essentially create a path outwardly from the severed portion of the tissue. This procedure may be performed after severing the tissue in this area so that the cuttingelement 205 can be initially positioned without RF power. The ultrasound markers described herein, and in particular the marker near the apex of the cuttingelement 205 when expanded and bowed, are particularly useful in properly positioning thecutting element 205 at this time. The cuttingelement 205 may then be powered with RF to partially or completely create the tissue channel. This procedure may be desirable when the cutting procedure causes thecutting element 205 to pass near the skin. Thecutting device 204 may also include a movableinsulating sleeve 261 which covers part of the cuttingelement 205, such as portions on the ends of the cuttingelement 205, during this part of the procedure to reduce the excess lateral cutting during creation of the tissue channel. - When removing the tissue, the tissue may be contained within a
tissue collection element 320 released by thecutting device 204 when the tissue is severed or which is deployed by itself after excision of the tissue. Thetissue collection element 320 may simply trail the cuttingelement 205 similar to the patents and applications incorporated by reference herein in which the tissue collection element remains coupled to the device. -
FIG. 37 shows thecollection element 320 containing the tissue with atether 322 extending from thetissue collection element 320 and being withdrawn as thecutting device 204 is removed. Thetether 322 may be used to guide advancement and engagement of thetissue removal device 300. For example, thetissue collection element 320 may have aconnector 324 which engages theremoval device 300 with a suitable mechanical, magnetic or suction connection. Theconnector 324 may be positioned at the end of thetether 322 so that engagement with theconnector 324 is easily guided by thetether 322. - Referring still to
FIG. 37 , thetether 322 may be particularly useful when removing the tissue through a separate incision since thetether 322 can be easily retrieved using a conventional suture snare or the like. Thetether 322 may also be used without thetissue collection element 320 by simply attaching thetether 320 to the tissue with a needle, screw 321 (seeFIG. 37 ) or other suitable attachment feature. Thetether 320 may be delivered by thecutting device 204 or may be part of another device such as the tissue removal devices described herein. - Referring to
FIGS. 39-41 , still another aspect of the present invention is shown. Thetissue cutting device 204 is shown and all features and aspects of the tissue cutting devices described herein are incorporated here. Thetissue cutting device 204 is shown sweeping around the tissue to be removed. The cuttingelement 205 is then partially retracted so that only a small piece of tissue connects the tissue to be removed from the surrounding tissue as shown in FIG. 41. Thetissue cutting device 205 may then be used to manipulate the tissue to assist or prepare the tissue for removal. Thetissue cutting device 204 may be designed to lock thecutting element 205 in the partially opened position ofFIG. 41 to trap the tissue between the cuttingelement 205 and theshaft 240 so that thecutting device 204 may be used to manipulate the tissue. For example, the tissue may be manipulated while the tissue is being encapsulated in a tissue collection element or when the tissue is being engaged by any of the tissue removal devices described herein such as thedevice 300. When it is desired to remove the tissue, the cuttingelement 205 is collapsed further to complete the cut. - The
tissue cutting device 204 may also mark the tissue sample and/or the tissue surrounding the tissue sample as shown inFIG. 42 . Marking the tissue may assist in identifying the tissue for removal or to mark the tissue remaining in the body for subsequent therapy or treatment. The tissue may be marked in any suitable manner such as those described in application Ser. No. 10/871,790, filed Jun. 17, 2004, which is hereby incorporated herein by reference in its entirety. For example, thetissue cutting device 204 may have one or moredye injection ports 330 to mark the tissue. Of course, the cutting device may also leave behind a marker, such as a spiral spring or coil as described above, to mark the tissue rather than marking the tissue with a dye or the like. It is understood that marking the tissue being removed and/or marking the tissue remaining in the body may be used in connection with any of the other features and aspects of the present invention including use with any of the tissue cutting or removal devices described herein. - The present invention has been described in connection with the preferred embodiments, however, it is understood that many alternatives are possible without departing from the scope of the invention.
Claims (4)
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
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US11/740,855 US20070197934A1 (en) | 1998-09-03 | 2007-04-26 | Devices and methods for performing procedures on a breast |
US13/525,912 US9521992B2 (en) | 2002-10-16 | 2012-06-18 | Devices and methods for performing procedures on a breast |
US13/668,144 US20130226028A1 (en) | 1998-09-03 | 2012-11-02 | Devices and methods for performing procedures on a breast |
US13/895,303 US20130253370A1 (en) | 2002-10-16 | 2013-05-15 | Devices and methods for performing procedures on a breast |
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Application Number | Priority Date | Filing Date | Title |
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US09/146,743 US6022362A (en) | 1998-09-03 | 1998-09-03 | Excisional biopsy devices and methods |
US09/417,520 US6423081B1 (en) | 1998-09-03 | 1999-10-13 | Excisional biopsy devices and methods |
US10/272,448 US6936014B2 (en) | 2002-10-16 | 2002-10-16 | Devices and methods for performing procedures on a breast |
US10/732,670 US7329253B2 (en) | 2003-12-09 | 2003-12-09 | Suction sleeve and interventional devices having such a suction sleeve |
US10/796,328 US7303531B2 (en) | 1998-09-03 | 2004-03-08 | Excisional biopsy devices and methods |
US10/923,511 US7517348B2 (en) | 1998-09-03 | 2004-08-20 | Devices and methods for performing procedures on a breast |
US11/740,855 US20070197934A1 (en) | 1998-09-03 | 2007-04-26 | Devices and methods for performing procedures on a breast |
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US13/895,303 Abandoned US20130253370A1 (en) | 2002-10-16 | 2013-05-15 | Devices and methods for performing procedures on a breast |
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US13/668,144 Abandoned US20130226028A1 (en) | 1998-09-03 | 2012-11-02 | Devices and methods for performing procedures on a breast |
US13/895,303 Abandoned US20130253370A1 (en) | 2002-10-16 | 2013-05-15 | Devices and methods for performing procedures on a breast |
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Also Published As
Publication number | Publication date |
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US20070203428A1 (en) | 2007-08-30 |
JP2008510596A (en) | 2008-04-10 |
US9521992B2 (en) | 2016-12-20 |
WO2007035177A3 (en) | 2007-12-13 |
EP1793757A4 (en) | 2010-02-24 |
US20120259242A1 (en) | 2012-10-11 |
US20130253370A1 (en) | 2013-09-26 |
US7517348B2 (en) | 2009-04-14 |
US20130226028A1 (en) | 2013-08-29 |
US20050119652A1 (en) | 2005-06-02 |
US20070203427A1 (en) | 2007-08-30 |
EP1793757A2 (en) | 2007-06-13 |
CA2575835A1 (en) | 2006-02-20 |
WO2007035177A2 (en) | 2007-03-29 |
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