US20120184874A1 - Methods and devices for removing tissue from a patient and placing a marker in the patient - Google Patents

Abstract

The device is used to remove tissue from a patient and to also place a marker in the patient. The device has an opening through which tissue enters the device. The tissue, which enters the opening is cut and the tissue is removed. The device may be used a number of times to remove a number of tissue masses. The device also includes a marker, which the user may release in the patient at the desired time.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims priority to U.S. application Ser. No. 11/099,985, filed on Apr. 5, 1005. The complete disclosure of which is hereby incorporated for all purposes.
BACKGROUND
• The present invention is directed to tissue removing devices and methods. The invention may be used to remove tissue from any part of the body and is particularly useful in removing tissue from the breast. Of course, the invention may be used in any other part of the body and use in the breast is merely exemplary.
SUMMARY
• In a first aspect of the present invention, a tissue removal device is provided which has a tubular element, a transport element and a cutting element. The tubular element has an open distal end. The transport element and the cutting element are positioned at least partially within the tubular element and are movable within the tubular element. The device is introduced into a patient and the tubular element is advanced so that tissue enters the tubular element through the open end. The cutting element is then used to cut or part-off the tissue which has entered the tubular element and the transport element is used to transport the tissue proximally to a tissue chamber.
• The transport element may take many forms. In one embodiment, the transport element has an open end positioned proximal to the open end of the tubular element so that tissue enters the open end of the transport element when the tubular element is advanced into tissue. The transport element may also pierce the tissue being removed from the patient. Furthermore, the transport element may have a deployable anchor, which secures the tissue to the transport element. The anchor may take any suitable shape such as deployable barbs, wires or an inflatable balloon.
• In another aspect of the present invention, the device may include a cutting element, which parts off the tissue, which enters the tubular element and also transports the tissue to the tissue chamber. The cutting element may have a first part and a second part, which move toward one another to a cutting position when cutting the tissue within the tubular element. The cutting element may be plastically or elastically deformed when moving to a cutting position.
• In another aspect of the present invention, devices and methods for removing tissue and placing a marker within the patient are described. The device includes an opening through which tissue is introduced into the device. The tissue is then cut to separate a tissue mass from the surrounding tissue. The device also includes a solid marker housed within the device. The marker may be implanted into the patient at any time desired by the user. The marker may be delivered through the same opening through which tissue is removed or the device may include a separate opening for delivering the marker. The marker may be mounted to the introducer, stored in a storage area in the handle, or may even be stored at a location distal to the opening through which tissue is removed.
• In still another aspect of the present invention, a method of removing tissue and marking a tissue area is provided in which the tissue marking element delivers a flowable material. The tissue marking element may have a plurality of outlets to form a recognizable pattern to help locate and orient the tissue area of interest at a later time when the flowable marking material is visualized. The tissue marking element may be advanced through the lumen of the tubular element until an outlet of the tissue marking element is positioned distal to the opening in the tubular element. The tissue marking element may also be part of the introducer with the introducer having one or more outlets through which the flowable substance is delivered.
• These and other aspects of the present invention shall become apparent from the following description, drawings and claims.
DESCRIPTION OF DRAWINGS
• FIG. 1 shows a tissue removing device in accordance with the present invention.
• FIG. 2 shows another view of the device ofFIG. 1.
• FIG. 3 is a cross-sectional view of a distal end of the tissue removal device with a cutting element in a stored position.
• FIG. 4 is a cross-sectional view showing the cutting element in a cutting position.
• FIG. 5 shows the device being introduced into tissue.
• FIG. 6 shows an introducer withdrawn from the distal end.
• FIG. 7 shows a tubular element advanced into tissue.
• FIG. 8 shows a cutting element cutting tissue, which has entered the tubular element.
• FIG. 9 shows the tissue being transported proximally.
• FIG. 10 shows the tissue positioned over a tissue chamber and contacting a distal end of the introducer.
• FIG. 11 shows the tissue falling into the tissue chamber.
• FIG. 12 is a cross-sectional view of another tissue removal device.
• FIG. 13 shows the device ofFIG. 12 introduced into tissue.
• FIG. 14 shows the introducer retracted.
• FIG. 15 shows the cutting element being advanced distally.
• FIG. 16 shows the cutting element in a cutting position.
• FIG. 17 shows the cutting element moving the tissue proximally toward the tissue chamber.
• FIG. 18 shows the tissue being released into the tissue chamber by the cutting element.
• FIG. 19 shows another device for removing tissue from a patient.
• FIG. 20 shows the cutting element cutting the tissue which has entered the tubular element.
• FIG. 21 shows still another device for removing tissue from a patient.
• FIG. 22 shows another anchor for the device ofFIG. 21.
• FIG. 23 shows still another anchor for the device ofFIG. 21.
• FIG. 24 is a cross-sectional view of another device for removing tissue from a patient and placing a marker in the patient.
• FIG. 25 shows the introducer moved to a position, which releases the marker.
• FIG. 26 shows still another device for removing tissue from a patient and placing a marker in the patient with the introducer withdrawn to permit tissue to be collected
• FIG. 27 shows the introducer withdrawn proximal to a marker storage area.
• FIG. 28 shows the introducer advancing the marker toward the open end.
• FIG. 29 shows yet another device for removing tissue from a patient and placing a marker in the patient with a cutting element cut tissue, which has entered the device through a side opening.
• FIG. 30 shows the marker being released from a marker storage area.
• FIG. 31 shows another device for removing tissue and marking a tissue area.
• FIG. 32 shows a tissue marking element entering the lumen.
• FIG. 33 shows the tissue marking element advanced to the distal end of the lumen with the introducer.
• FIG. 34 shows the introducer advanced to move a piston within the tissue marking element to force the flowable substance into the tissue area.
• FIG. 35 shows yet another device for removing tissue and marking a tissue area with an introducer having an outlet through which a flowable marker is delivered.
• FIG. 36 shows the device ofFIG. 35 with the flowable material delivered.
• FIG. 37 shows still another device for removing tissue and marking a tissue area.
• FIG. 38 shows a tissue marking element moved to a working position within an introducer.
• FIG. 39 shows yet another device for removing tissue and marking a tissue area.
• FIG. 40 shows an external view of the device ofFIG. 39.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Referring toFIGS. 1-11, atissue removing device2 according to the present invention is shown. The devices and methods described herein may be used to remove tissue from any location in the body and an example of such a use is removal of tissue from the breast as described below. Thetissue removal device2 has atubular element4 which is advanced into tissue so that tissue is received through anopen end6 of thetubular element4. Atransport element7 is positioned within thetubular element4 and is used to transport tissue back to atissue sample chamber30 as described below.
• The distal end of thetubular element4 is beveled to form asharp tip11 but may take any other suitable configuration which penetrates tissue. Thetubular element4 may also be rotated when driven into the tissue. Thetubular element4 may be made of any suitable material such as stainless steel. Thedevice2 may also include anintroducer20 positioned in thetubular element4 during introduction. Theintroducer20 may have asharp tip22 which penetrates the tissue during introduction of thedevice2 as shown inFIG. 5. Thedevice2 may also be introduced through a sheath, trocar or cannula (not shown) which penetrates the tissue rather than using thedevice2 itself to penetrate the tissue.
• Although the present invention may be used to collect tissue of any size, the invention is particularly useful in removing relatively small quantities of tissue such as required in breast biopsies. When used for this purpose, the inner diameter of thedevice2 may be less than 5 mm or even less than 3.5 mm. The present invention provides the ability to obtain small, cylindrical tissue samples which are relatively undisturbed compared to many prior art solutions. Thetubular element4 may be driven forward a distance of 15-25 mm which may be selected by the user.
• Thetissue removal device2 also has a cuttingelement10 which is used to cut or “part off” tissue which has entered thetubular element4 from the surrounding tissue. The cuttingelement10 is stored between thetubular element4 and thetransport element7 and naturally assumes the position ofFIG. 4 when advanced. The cuttingelement10 also contacts aprotrusion11 on aninner surface13 of thetubular element4 which directs the cuttingelement10 into the cutting position ofFIG. 4. Theprotrusion11 may simply be aring15 of material attached to the inner surface of thetubular element4 although any other structure may be used. Thetransport element4 and cuttingelement10 are then moved proximally to the tissue chamber with the cuttingelement10 remaining in the cutting position ofFIG. 4 as explained below.
• Thetissue removal device2 has afirst actuator24 and asecond actuator26 which are described further below in connection with use of thedevice2. Of course, fewer actuators may be used if the function of the actuators can be combined. When thefirst actuator24 is depressed, theintroducer20 is retracted proximally to the position shown inFIG. 6 so that the open end of thetubular element4 is exposed to receive tissue. When thesecond actuator26 is depressed, thetubular element4 is driven forward so that tissue enters theopen end6. The cuttingelement10 is then automatically advanced to part off tissue, which has entered theopen end10 and thetransport element7 then transports the tissue to thetissue chamber30. The first andsecond actuators24,26 may be knobs, buttons, levers or triggers andFIGS. 1 and 2 show the first andsecond actuators24,26 being buttons.
• Use of thetissue removal device2 is now described in connection withFIGS. 5-11. Thedevice2 is introduced into the patient for removal of tissue such as breast tissue in a breast biopsy procedure. Thedevice2 is introduced directly into the tissue with thesharp tip22 of theintroducer20 penetrating tissue as shown inFIG. 5. Thedevice2 may also be introduced into the patient through a sheath, trocar or cannula (not shown). Once the distal end is positioned proximal to the tissue to be removed, thefirst actuator24 is depressed to withdraw theintroducer20 and expose theopen end6 as shown inFIG. 6. After retracting theintroducer20 the user may, of course, manipulate thedevice2 as necessary so that thedevice2 is directed toward the tissue to be removed. Theintroducer20 may be withdrawn to a position proximal to thetissue chamber30 or another suitable position.
• Thesecond actuator26 is then depressed which causes thetubular element4 to be driven forward so that tissue enters theopen end6 as shown inFIG. 7. Thetransport element7 may be advanced with thetubular element4 or may be driven independently of thetubular element4 without departing from the invention. For example, thetransport element7 may be driven into the position ofFIG. 7 after thetubular element4 has been driven into the tissue and even after the cuttingelement10 has been deployed to the position ofFIG. 8. Thetubular element4 may also be rotated while being driven forward, for example, thetubular element4 may be rotated 0.5 to 60 revolutions when driven forward. Thetubular element4 may also simply be translated (without rotating) without departing from numerous aspects of the present invention. Theintroducer20 may be advanced with thetubular element4 as shown inFIG. 7.
• The cuttingelement10 is then advanced until it contacts theprotrusion11 and is directed into the tissue which has entered thetubular element4 as shown inFIGS. 4 and 8. The cuttingelement10 extends toward and through a longitudinal axis defined by thetubular element4 and forms an angle of about 70 degrees with the longitudinal axis although any other suitable angle may be used. The cuttingelement10,transport element7 and/ortubular element4 may also be rotated to aid in cutting the tissue. The cuttingelement10 may be rotated with thetubular element4 in the same direction or in opposite directions when parting off the tissue which has entered thedevice2.
• Thetransport element7 and cuttingelement10 then move proximally toward thetissue chamber30 as shown inFIG. 9. Theintroducer20 is positioned so that continued proximal movement of thetransport element7 brings the tissue into contact with the distal end of theintroducer20 as shown inFIG. 10. Continued proximal movement of thetransport element7 completely exposes the tissue and permits the tissue to fall into thetissue chamber30 as shown inFIG. 11. Thetubular element4 has anopening32 leading to thetissue chamber30 to permit the tissue to fall into thetissue chamber30 when thetubular element4 is in the position ofFIG. 11.
• The cuttingelement10 is straightened by withdrawing the cuttingelement10 into a recess (not shown). The cuttingelement10 andtransport element7 are then moved back to the position ofFIG. 6. Thetubular element4 may remain within the patient during transport of the tissue to thetissue chamber30 so that thedevice2 is ready to take another tissue mass without removing thedevice2 from the patient. The user may re-orient thedevice2 as necessary so that thetubular element4 is directed at tissue to be removed. The user then actuates thesecond actuator26 again which causes thetubular element4 to be driven forward to collect another tissue mass. If a tissue mass is desired at another location, the user may actuate thefirst actuator24 to move theintroducer20 back to the position ofFIG. 5. Thedevice2 may then be manipulated to position thedevice2 at the next location where tissue is to be removed. Of course, theintroducer20 may also be automatically repositioned after each collecting each tissue mass.
• Referring toFIGS. 12-18, anotherdevice2A for removing tissue is shown wherein the same or similar reference numbers refer to the same or similar structure. The cuttingelement10A has afirst part40 and asecond part42 which may be integrally formed or may be independent elements. The first andsecond parts40,42 move inwardly to cut the tissue which has entered thetubular element4 as shown inFIG. 12. The first andsecond parts40,42 move inwardly when they engage aprotrusion44 on aninner wall46 of the tubular element4A as shown inFIG. 12. The protrusion16 may be a ring21 which directs the first andsecond parts40,42 inwardly.
• The first andsecond parts40,42 may each include aportion50 which undergoes plastic deformation when moving to the position ofFIG. 12. The first andsecond parts40,42 remain in the closed position until they are withdrawn into recesses (not shown) which straighten the twoparts40,42. The first andsecond parts40,42 may also lock together or may be naturally biased to the position ofFIG. 12 rather than being plastically deformed without departing from numerous aspects of the present invention.
• The cuttingelement10A is used to transport the tissue to thetissue chamber30 after parting off the tissue. The cuttingelement10A moves proximally as shown inFIGS. 17 and 18 to transport the tissue to thetissue chamber30. The tissue may contact theintroducer20 or another part of thedevice2A as the tissue is moved proximally to help release the tissue from the cuttingelement10A.
• Use of thedevice2A is similar to use of thedevice2 described above. Thefirst actuator24 is depressed to retract theintroducer20 as shown inFIG. 14. Thesecond actuator26 is then depressed which causes the tubular element4A to be advanced into tissue as shown inFIG. 14. The cuttingelement10A is then advanced to part off the tissue which entered the open end as shown inFIGS. 12 and 16. The cuttingelement10A may be moved together with the tubular element4A when the tubular element4A is advanced or may be driven over the tissue after the tissue has entered the tubular element4A. The cuttingelement10A then moves proximally toward thetissue chamber30 as shown inFIG. 17 and deposits the tissue in thetissue chamber30 as shown inFIG. 18. The first andsecond parts40,42 are opened when they are withdrawn into the recesses (not shown).
• The tubular element4A and cuttingelement10 are then moved back into position to take another tissue mass. As such, thetissue removal device2 does not need to be removed from the patient so that the user may simply reorient thedevice2 or move thedevice2 to another location where tissue is to be removed as described above. The method described in connection withFIGS. 12-18 may also be accomplished with the device ofFIGS. 2-11 in that the cuttingelement10 may be used to transport the tissue mass by itself. Such a method and use of thedevice2 ofFIGS. 1-11 is expressly incorporated here.
• Referring toFIGS. 19 and 20, anothertissue removal device2B is shown wherein the same or similar reference numbers refer to the same or similar structure. Thetissue removal device2B has a tubular element4B which is driven into tissue. Thedevice2B also has the cuttingelement10 which parts off the tissue in the tubular element4B and thetissue chamber30 which receives the tissue (seeFIGS. 1 and 2). The cuttingelement10 and/or tubular element4B may be rotated to aid in cutting the tissue. The cuttingelement10 may be rotated with thetubular element4 in the same direction or in opposite directions when parting off the tissue which has entered thedevice2B. Thedevice2B also has the first andsecond actuators24,26 which function in the same manner as the first andsecond actuators24,26 described above (also shown inFIGS. 1 and 2).
• Thedevice2B also includes atransport element60 which moves within the tubular element4B and engages the tissue. Thetransport element60 may be any suitable element which engages and contacts the tissue mass. For example, thetransport element60 may be awire62 having asharp tip64 which pierces the tissue. Thewire62 may be curved or helical so that thewire62 may be pivoted or rotated into engagement with the tissue. Thetransport element60 may be advanced into the tissue before the tubular element4B or may be driven into the tissue at the same time as the tubular element4A or even after the tubular element4B has been driven into the tissue.
• Once thetransport element60 and the tubular element4A are in the position ofFIG. 20, thetransport element60 moves proximally to carry the tissue toward thetissue chamber30. Thetransport element60 may also be rotated in the same direction that was used to engage the tissue when transporting the tissue mass proximally to help maintain engagement with the tissue. The tissue is transported proximally until the tissue contacts theintroducer20 in the manner described above (seeFIG. 11). Thetransport element60 is then withdrawn thereby permitting the tissue mass to fall into thechamber30. Thetransport element60 may be rotated when being withdrawn from the tissue so that thewire62 withdraws smoothly from the tissue. Thetransport element60, tubular element4A and cuttingelement10 are then moved back into position to take another tissue mass without removing thedevice2B from the patient as described above.
• Referring toFIG. 21, another tissue removal device2C is shown wherein the same or similar reference numbers refer to the same or similar structure. The device2C has a piercingelement82 which pierces the tissue. The piercingelement82 also has adeployable anchor83 which secures the tissue to the piercingelement82. Theanchor83 may take any suitable form. For example, theanchor83 may be one or more retractable barbs84 which hold the tissue as shown inFIG. 21. The barbs84 may be slightly curved to help hold the tissue on the piercing element80 but may take any other suitable shape. Theanchor82 may also be one ormore wires86 extending from the piercingelement82 as shown inFIG. 22 or may be aninflatable balloon88 as shown inFIG. 23.
• The device2C also has the first andsecond actuators24,26 (seeFIGS. 1 and 2) which operate in the manner described above. The device also has athird actuator27 which advances the piercingelement82 when actuated. The piercingelement82 is then moved proximally after thethird actuator27 is actuated again as described below to transport the tissue to thetissue chamber30.
• The device2C may be operated in a number of different ways including the two now described. In one method, the piercingelement82 is driven into the tissue before thetubular element4 when the user actuates thethird actuator27. Thetubular element4 is then driven over the piercingelement82 when the user actuates thesecond actuator26. The piercingelement82 is then moved proximally to tear the tissue from the surrounding tissue. This step may be performed manually or by actuating thethird actuator27 again. The tissue is then transported proximally by actuating thethird actuator27 again if the user has parted-off the tissue manually.
• The piercingelement82 moves proximally until the tissue is over thetissue chamber30 at which time theanchor83 is automatically released by withdrawing the barbs84 orwires86 or deflating theballoon88. Further retraction of the piercing element80 withdraws the piercing element80 completely thereby permitting the tissue to fall into thetissue chamber30 as described above in connection with theother devices2,2A,2B. After the tissue has been deposited into thetissue chamber30, the device2C is ready to take another sample without removal from the patient as described above.
• In another method of operating the device2C, thetubular element4 is driven into the tissue first and the piercingelement82 is then driven into the tissue after the tissue has entered thetubular element4. Theanchor83 is then deployed to secure the tissue to the piercing element80. The tissue is then separated from the surrounding tissue and transported to thetissue chamber30 as described above.
• Referring toFIGS. 24 and 25, anothertissue removing device100 is shown. Thedevice100 may also be used to remove tissue and to place amarker102 in the patient. Thedevice100 is similar to other devices described herein, such as thedevice2A ofFIGS. 16-18, and the same or similar reference numbers refer to the same or similar structure. Thedevice100 may include the same features and may be used in substantially the same manner as the device ofFIGS. 16-18 and all disclosure related to the structure and use ofdevice2A is incorporated here. Themarker102 may be any suitable marker such as a polylactic-polyglycolic acid copolymer with a metallic clip or a collagen material with a metallic clip contained therein and may be used for any purpose such as marking a breast. Themarker102 is preferably a solid marker rather than a dye or liquid. The term “solid” as used herein may include soft materials such as gel-like materials or otherwise flexible materials so long as the material is not a liquid which may disperse and/or reduce in concentration over time.
• Themarker102 may be delivered at a time selected by the user as described herein. Themarker102 is mounted to anintroducer104 which has a sharpdistal end106 to pierce tissue when introducing thedevice100. Of course, thedevice100 may also be introduced through a trocar, sheath, cannula or the like as described above. Themarker102 is stored within arecess106 in theintroducer104. Theintroducer104 also has aport108 through which themarker100 leaves theintroducer104. Apusher110 moves themarker102 out of theport108 when theport108 is exposed as shown inFIG. 25. Thepusher110 is biased by aspring112 to automatically move themarker102 out of theport108 when theport108 is exposed. Themarker102 may also be moved out of the opening by using a pulse of fluid (either a gas such as carbon dioxide or a liquid such as saline) to exert pressure on themarker102 to force the marker out of the opening.
• Use of thedevice100 is now described. Thedevice100 may be used to remove a number of tissue masses from a patient in the same manner as described above. Thedevice100 may include the cuttingelement10A (seeFIGS. 16-18) or any other suitable structure or method may be used to cut, part-off or otherwise separate the tissue in thedevice100 from the surrounding tissue including any of those described herein. Furthermore, thedevice100 is shown having the opendistal end6 but may have a side opening rather theopening6 at the distal end without departing from various aspects of the invention. When the user desires to place themarker102 in the patient, an actuator is actuated which causes theintroducer104 to be advanced to the position ofFIG. 24 which is essentially the same position used when introducing thedevice100 into the patient. Theintroducer104 may then continue to move distally thereby exposing theport108. Alternatively, thetubular element4 may be withdrawn to expose theport108 or theport108 may be exposed by a combination of advancing theintroducer104 and withdrawing thetubular element4.
• Referring toFIGS. 26-28, anotherdevice120 is shown which may be used to remove tissue from a patient and also place themarker102 in the patient. Thedevice120 is also similar to thedevice2A ofFIGS. 16-18 and discussion of thedevice2A and methods of use are expressly incorporated here.FIGS. 26-28 show a proximal part of thedevice120 to illustrate storage and delivery of themarker102. Themarker102 is contained in astorage area122 in thedevice120. Thedevice120 stores threemarkers102 although any suitable number may be stored. Themarker storage area122 also has apusher element124 which is biased by aspring126 to move the marker out of thearea122 and into alumen128. Thedevice120 also has anintroducer129 which is withdrawn to the position ofFIG. 27 so that one of themarkers102 may move into thelumen128. Themarker102 is then moved through thelumen128 and ultimately out of the distal opening by theintroducer129 as shown inFIG. 28. Thedevice120 also includes an actuator (not shown) which is actuated by the user when the user desires to implant themarker102. Upon actuation, theintroducer129 is automatically withdrawn to the position ofFIG. 27 to permit one of themarkers102 to enter thelumen128. Theintroducer129 then automatically moves distally to push themaker102 out through theopen end6 of thetubular element4.
• Use of thedevice120 is now described. Thedevice120 may be used to remove a number of tissue masses from a patient as described above. Although thedevice120 is shown with the cuttingelement10A, any other suitable structure or method may be used to cut, part-off or otherwise separate the tissue in thedevice120 from the surrounding tissue such as those described herein. When the user desires to place themarker102 in the patient, thesuitable actuator24,26,27 is actuated. Theintroducer129 is then retracted proximal to themarker storage area122 as shown inFIG. 27. One of themarkers102 is then moved into thelumen128 by thepusher124. Theintroducer129 is then automatically advanced so that themarker102 is pushed out through theopen end6 of thedevice120 as shown inFIG. 30.
• Referring now toFIGS. 29 and 30, yet anotherdevice130 for removing tissue and placing themarker102 within a patient is shown. Thedevice130 has aside opening132 through which tissue enters thedevice130. A cuttingelement134 shears off material which extends into thedevice130 through theopening132 as shown inFIG. 28. Thedevice130 may use suction to draw tissue into theopening132 or may be forced laterally so that tissue enters theopening132. Thedevice130 also includes themarker102 housed in amarker storage area136 positioned distal to theside opening132. Themarker storage area136 has anopening138 which is covered with a sliding door140. When the door140 is opened as shown inFIG. 29, a spring-loaded pusher142 forces themarker102 out of theopening138. Themarker102 is released at the desired time by the user upon actuation of an actuator (seeactuators24,26,27 ofFIG. 1). Themarker102 may also be delivered through theopening132 through which tissue is removed without departing from various aspects of the invention.
• Referring toFIGS. 31-34, still anotherdevice200 for removing tissue and marking a tissue area is shown wherein the same or similar reference numbers refer to the same or similar structure. Thedevice200 is similar to the devices described above and the features and use of the devices described above are incorporated here. Thedevice200 has atissue marking element202 which delivers aflowable substance204 to mark tissue in the patient. Theflowable substance204 may be any suitable substance which may visualized after the procedure using a suitable technique such as x-ray or ultrasound.
• Thetissue marking element202 has achamber206 which holds theflowable substance204. The tissue marking element may also include aneedle208 having anoutlet210 through which thesubstance204 is delivered. A piston orplunger212 forces theflowable substance204 through theoutlet210 as shown inFIG. 34.
• Thedevice200 may be used to remove tissue using any suitable method including all of those described herein, which are expressly incorporated here. Theflowable substance204 may be applied when the user desires upon actuation of the appropriate actuator (seeactuators24,26,27 ofFIG. 1). For example, the user may first remove a number of tissue masses as described herein followed by delivery of theflowable substance204 to mark tissue. Alternatively, theflowable substance204 may be automatically delivered after a set or predetermined number of tissue masses have been removed.
• Thetissue marking element202 is stored in amarker storage area214 adjacent to alumen216 in atubular element218 similar to other embodiments described herein as shown inFIG. 31. The device may include a storage area for a number oftissue marking elements202 andFIG. 31 shows threetissue marking elements202 in thestorage area214. An introducer220 is retracted to the position ofFIG. 32 which permits thetissue marking element202 to enter thelumen216. Aspring222 may be used to force thetissue marking element202 into thelumen216. Thetissue marking element202 is then advanced through thelumen216 by the introducer220 until theneedle208 pierces the tissue as shown inFIG. 33. Thetissue marking element202 andlumen216 are configured so that thetissue marking element202 cannot pass completely through anopening224 at the distal end of thelumen216. Once thetissue marking element202 is positioned at theopening224 as shown inFIG. 32 further distal movement of the introducer pushes theplunger212 so that the flowable substance is delivered through the outlet and into the tissue as shown inFIG. 34.
• Referring toFIGS. 35 and 36, still anotherdevice300 for removing tissue and marking a tissue site is shown wherein the same or similar reference numbers refer to the same or similar structure. Thedevice300 is similar to the devices described above and all features and methods of use described herein are incorporated here. Thedevice300 includes anintroducer302 which hascontainer303 which holds theflowable substance307. Thecontainer303 may simply be alumen304 having one ormore outlets306 formed at the distal end of theintroducer302 through which theflowable substance307 is delivered. Apiston308 is movable within thelumen304 to force theflowable substance307 through theoutlets306. Theoutlets306 may be formed by elastomeric portions310 in a manner similar to a one-way valve, such as a duckbill valve, so that theoutlets306 are normally closed to prevent theflowable material307 from escaping. Theoutlets306 will also inhibit material from entering thelumen304. Thelumen304 may have oneoutlet306 or a plurality ofoutlets306 configured in a recognizable pattern, which may be useful to orient or otherwise help identify the position and/or orientation of the tissue area of interest when viewed at a later time. For example, theoutlets306 may be configured in a triangle or any other suitable shape.
• Referring toFIGS. 37 and 38, yet anotherdevice400 for removing a tissue mass and marking a tissue area is shown. Thedevice400 is similar to the devices described above and all common features and methods described above are incorporated here. The device includes anintroducer402 having alumen404 in which atissue marking element406 is positioned. Thetissue marking element406 has aplunger408 which is depressed by apusher element411 to force the flowable substance through anoutlet412 in thetissue marking element406. Aspring414 holds thetissue marking element406 in the stored position ofFIG. 37. Thetissue marking element406 may also include aneedle416 having the412 which deposits the flowable substance into tissue when theneedle416 pierces tissue.
• Referring now toFIGS. 39 and 40, still anotherdevice450 for removing tissue and marking a tissue area is shown. Thedevice450 is similar to other devices described herein and all such uses and features of those devices are incorporated here. For example, thedevice450 may be used to remove and collect tissue in any manner described herein prior to marking of the tissue area.
• Thedevice450 has a chamber orcontainer452 which holds theflowable substance307. Thecontainer452, which may simply be a length of tubing, is coupled to alumen454 through which theflowable substance307 may be delivered. Thecontainer452 andlumen454 are coupled to atubular element456 but may also be integrated into thetubular element456. Thelumen454 has anoutlet460 through which theflowable substance307 is delivered. Thecontainer452 may be coupled to a series oflumens454 each having one ormore outlets460. For example, the device may have three outlets positioned 120 degrees apart to form a recognizable pattern. The pattern may be used to orient and/or identify the tissue area which has been marked when viewed using ultrasound, x-ray or another suitable visualization technique at a later time. Theoutlets460 are positioned on an outer surface of thetubular element456 near a distal end of thetubular element456. Of course, thedevice450 may include any number ofoutlets460 including only oneoutlet460. Theoutlets460 may also be normally closed similar to a one-way valve as described in connection with theoutlets306 ofFIGS. 35 and 36. Aplunger453 is used to force theflowable substance307 through theoutlets460.
• The tissue removing devices described inFIGS. 31-40 may be used to collect a number of tissue masses in any suitable manner described herein and all such uses are incorporated here in combination with the structure and features associated with marking tissue.
• The present invention has been described in connection with various preferred embodiments, however, it is understood that various modifications and alternative configurations are possible without departing from the scope of the invention. For example, the piercing element may be adhered to the tissue in any other suitable manner other than using the deployable anchor.

Claims (26)

1-45. (canceled)

46. A device for removing tissue from a patient and marking tissue which remains within the body, comprising:

a body;

a tubular element extending from the body, the tubular element having an opening, wherein tissue is received within the opening; and

a tissue marking element coupled to the tubular element, the tissue marking element including a container having an outlet, the container containing a flowable substance, the tissue marking element, the tissue marking element being movable within the tubular element from a stored position to a working position, the tissue marking element being closer to the opening when in the working position than in the stored position.

47. The device ofclaim 46, wherein:

the tissue marking element is configured to deposit the flowable substance into the tissue to mark the tissue.

48. The device ofclaim 46, wherein:

the tissue marking element moves distally within the lumen when moving from the stored position to the working position, the outlet of the tissue marking element being positioned distal to the opening in the tubular element when in the working position and proximal to the opening when in the stored position.

49. The device ofclaim 46, further comprising:

an introducer movable from a first position to a second position, the introducer covering the opening when in the first position and being spaced apart from the opening when in the second position.

50. The device ofclaim 49, wherein:

the tissue marking element is moved to the working position by the introducer.

51. The device ofclaim 49, wherein:

the tissue marking element is formed by the introducer, the introducer having at least one channel in fluid communication with the outlet, the flowable substance being delivered through the channel and the outlet.

52. The device ofclaim 46, wherein:

the tissue marking element has a plurality of outlets through which the flowable substance is delivered.

53. The device ofclaim 46, wherein:

the tissue marking element having a needle, the outlet being formed in the needle, the outlet being moved to a position distal to the opening in the tubular element when the tissue marking element is in the working position.

54. The device ofclaim 46, further comprising:

a marker storage area positioned outside the lumen, the tissue marking element being positioned in the marker storage area when in the stored position, the tissue marking element being moved inside the lumen and advanced distally through the lumen when moving to the working position.

55. The device ofclaim 46, wherein:

the body includes a tissue storage area in which tissue removed from the patient through the opening in the tubular element is stored.

56. The device ofclaim 46, wherein:

the tubular element is movable in a distal direction relative to the body, the tubular element moving distally so that tissue enters the tubular element through the opening.

57. The device ofclaim 46, further comprising:

means for transporting a tissue mass proximally through the lumen in the tubular element, the tissue mass entering the tubular element through the opening and being separated from the surrounding tissue.

58. The device ofclaim 46, further comprising:

a cutting element movable within the tubular element, the cutting element moving within the tubular element to sever tissue which has entered the tubular element through the opening.

59. The device ofclaim 46, further comprising:

an introducer movable from a first position to a second position, the introducer covering the opening when in the first position and being spaced apart from the opening when in the second position;

the tissue marking element being positioned within the introducer.

60. The device ofclaim 59, wherein:

the tissue marking element is movable within the introducer, the tissue marking element moving distally within the tissue marking element when moving from the stored position to the working position.

61. A method of removing tissue from a patient and marking tissue which remains within the body, comprising the steps of:

providing a tissue removing device having an opening and a tissue marking element, the tissue marking element including a container having an outlet, the container containing a flowable substance;

introducing the tissue removing device into a patient so that the opening is adjacent to a tissue area of interest in a patient;

passing a tissue mass through the opening and into the tissue removing device;

severing the tissue mass from surrounding tissue so that the tissue mass is at least partially contained in the tissue removing device; and

forcing the flowable substance through the outlet of the tissue marking element, the flowable substance being deposited in tissue thereby marking the tissue.

62. The method ofclaim 61, wherein:

the providing step is carried out with the tissue removing device including a tubular element, the tubular element having a lumen with the opening being at a distal end of the lumen; and

the passing step is carried out by advancing the tubular element in a distal direction so that the tissue mass enters the lumen through the opening.

63. The method ofclaim 62, wherein:

the providing step is carried out with the device having a plurality of outlets positioned on an external surface of the tubular element.

64. The method ofclaim 61, wherein:

the providing step is carried out with the tissue marking element having a plurality of outlets; and

the forcing step is carried out with the flowable substance being delivered through the plurality of outlets.

65. The method ofclaim 61, wherein:

the forcing step is carried out with the flowable substance being delivered through the plurality of outlets to form a pattern.

66. The method ofclaim 61, wherein:

the passing and severing steps are carried out a plurality of times to collect a plurality of tissue masses before the injecting step, the plurality of tissue masses being stored in the tissue removing device, the passing and severing steps being carried out without removing a distal end of the device from the tissue.

67. The method ofclaim 61, wherein:

the providing step is carried out with the tissue removing device including a tubular element having a lumen, the opening being at a distal end of the tubular element, the device also having a cutting element movable within the lumen; and

the severing step being carried out with the cutting element moving within the lumen to sever the tissue mass.

68. The method ofclaim 61, further comprising the step of:

transporting the tissue mass which has been separated from surrounding tissue during the severing step proximally through the lumen.

69. The method ofclaim 61, further comprising the step of:

transporting the tissue mass which has been separated from surrounding tissue during the severing step proximally through the lumen using a cutting element;

the severing step being carried out by severing the tissue with the cutting element.

70-75. (canceled)

Images