Methods and devices for removing tissue from a patient and placing a marker in the patient
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.
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.
BACKGROUNDThe 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.
SUMMARYIn 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
Referring to
The distal end of the tubular element 4 is beveled to form a sharp tip 11 but may take any other suitable configuration which penetrates tissue. The tubular element 4 may also be rotated when driven into the tissue. The tubular element 4 may be made of any suitable material such as stainless steel. The device 2 may also include an introducer 20 positioned in the tubular element 4 during introduction. The introducer 20 may have a sharp tip 22 which penetrates the tissue during introduction of the device 2 as shown in
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 the device 2 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. The tubular element 4 may be driven forward a distance of 15-25 mm which may be selected by the user.
The tissue removal device 2 also has a cutting element 10 which is used to cut or “part off” tissue which has entered the tubular element 4 from the surrounding tissue. The cutting element 10 is stored between the tubular element 4 and the transport element 7 and naturally assumes the position of
The tissue removal device 2 has a first actuator 24 and a second actuator 26 which are described further below in connection with use of the device 2. Of course, fewer actuators may be used if the function of the actuators can be combined. When the first actuator 24 is depressed, the introducer 20 is retracted proximally to the position shown in
Use of the tissue removal device 2 is now described in connection with
The second actuator 26 is then depressed which causes the tubular element 4 to be driven forward so that tissue enters the open end 6 as shown in
The cutting element 10 is then advanced until it contacts the protrusion 11 and is directed into the tissue which has entered the tubular element 4 as shown in
The transport element 7 and cutting element 10 then move proximally toward the tissue chamber 30 as shown in
The cutting element 10 is straightened by withdrawing the cutting element 10 into a recess (not shown). The cutting element 10 and transport element 7 are then moved back to the position of
Referring to
The first and second parts 40, 42 may each include a portion 50 which undergoes plastic deformation when moving to the position of
The cutting element 10A is used to transport the tissue to the tissue chamber 30 after parting off the tissue. The cutting element 10A moves proximally as shown in
Use of the device 2A is similar to use of the device 2 described above. The first actuator 24 is depressed to retract the introducer 20 as shown in
The tubular element 4A and cutting element 10 are then moved back into position to take another tissue mass. As such, the tissue removal device 2 does not need to be removed from the patient so that the user may simply reorient the device 2 or move the device 2 to another location where tissue is to be removed as described above. The method described in connection with
Referring to
The device 2B also includes a transport element 60 which moves within the tubular element 4B and engages the tissue. The transport element 60 may be any suitable element which engages and contacts the tissue mass. For example, the transport element 60 may be a wire 62 having a sharp tip 64 which pierces the tissue. The wire 62 may be curved or helical so that the wire 62 may be pivoted or rotated into engagement with the tissue. The transport element 60 may be advanced into the tissue before the tubular element 4B or may be driven into the tissue at the same time as the tubular element 4A or even after the tubular element 4B has been driven into the tissue.
Once the transport element 60 and the tubular element 4A are in the position of
Referring to
The device 2C also has the first and second actuators 24, 26 (see
The device 2C may be operated in a number of different ways including the two now described. In one method, the piercing element 82 is driven into the tissue before the tubular element 4 when the user actuates the third actuator 27. The tubular element 4 is then driven over the piercing element 82 when the user actuates the second actuator 26. The piercing element 82 is then moved proximally to tear the tissue from the surrounding tissue. This step may be performed manually or by actuating the third actuator 27 again. The tissue is then transported proximally by actuating the third actuator 27 again if the user has parted-off the tissue manually.
The piercing element 82 moves proximally until the tissue is over the tissue chamber 30 at which time the anchor 83 is automatically released by withdrawing the barbs 84 or wires 86 or deflating the balloon 88. Further retraction of the piercing element 80 withdraws the piercing element 80 completely thereby permitting the tissue to fall into the tissue chamber 30 as described above in connection with the other devices 2, 2A, 2B. After the tissue has been deposited into the tissue chamber 30, the device 2C is ready to take another sample without removal from the patient as described above.
In another method of operating the device 2C, the tubular element 4 is driven into the tissue first and the piercing element 82 is then driven into the tissue after the tissue has entered the tubular element 4. The anchor 83 is then deployed to secure the tissue to the piercing element 80. The tissue is then separated from the surrounding tissue and transported to the tissue chamber 30 as described above.
Referring to
The marker 102 may be delivered at a time selected by the user as described herein. The marker 102 is mounted to an introducer 104 which has a sharp distal end 106 to pierce tissue when introducing the device 100. Of course, the device 100 may also be introduced through a trocar, sheath, cannula or the like as described above. The marker 102 is stored within a recess 106 in the introducer 104. The introducer 104 also has a port 108 through which the marker 100 leaves the introducer 104. A pusher 110 moves the marker 102 out of the port 108 when the port 108 is exposed as shown in
Use of the device 100 is now described. The device 100 may be used to remove a number of tissue masses from a patient in the same manner as described above. The device 100 may include the cutting element 10A (see
Referring to
Use of the device 120 is now described. The device 120 may be used to remove a number of tissue masses from a patient as described above. Although the device 120 is shown with the cutting element 10A, any other suitable structure or method may be used to cut, part-off or otherwise separate the tissue in the device 120 from the surrounding tissue such as those described herein. When the user desires to place the marker 102 in the patient, the suitable actuator 24, 26, 27 is actuated. The introducer 129 is then retracted proximal to the marker storage area 122 as shown in
Referring now to
Referring to
The tissue marking element 202 has a chamber 206 which holds the flowable substance 204. The tissue marking element may also include a needle 208 having an outlet 210 through which the substance 204 is delivered. A piston or plunger 212 forces the flowable substance 204 through the outlet 210 as shown in
The device 200 may be used to remove tissue using any suitable method including all of those described herein which are expressly incorporated here. The flowable substance 204 may be applied when the user desires upon actuation of the appropriate actuator (see actuators 24, 26, 27 of
The tissue marking element 202 is stored in a marker storage area 214 adjacent to a lumen 216 in a tubular element 218 similar to other embodiments described herein as shown in
Referring to
Referring to
Referring now to
The device 450 has a chamber or container 452 which holds the flowable substance 307. The container 452, which may simply be a length of tubing, is coupled to a lumen 454 through which the flowable substance 307 may be delivered. The container 452 and lumen 454 are coupled to a tubular element 456 but may also be integrated into the tubular element 456. The lumen 454 has an outlet 460 through which the flowable substance 307 is delivered. The container 452 may be coupled to a series of lumens 454 each having one or more outlets 460. 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. The outlets 460 are positioned on an outer surface of the tubular element 456 near a distal end of the tubular element 456. Of course, the device 450 may include any number of outlets 460 including only one outlet 460. The outlets 460 may also be normally closed similar to a one-way valve as described in connection with the outlets 306 of
The tissue removing devices described in
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
1. A method of removing material from a patient and placing a marker within the patient, comprising the step of:
- providing a tissue removing device including a tubular element having an opening through which tissue is removed, the tissue removing device also having a solid marker;
- introducing the tissue removing device into a patient;
- placing tissue in the device through the opening;
- cutting the tissue which has entered the device through the opening to separate the a tissue mass from the surrounding tissue;
- moving the solid marker out of the opening; and
- removing the tissue removing device and the tissue mass from the patient leaving the solid marker inside the patient.
2. The method of claim 1, wherein:
- the placing step is carried out by advancing the tubular element into tissue so that tissue enters the opening; and
- the providing step is carried out with the opening being at a distal end of the tubular element.
3. The method of claim 1, wherein:
- the moving step is carried out with the marker being mounted to an introducer; and
- the introducing step is carried out with the introducer covering the opening.
4. The method of claim 3, wherein:
- the placing and cutting steps are carried out a number of times to create a plurality of tissue masses; and
- the moving step is carried out at a time selected by the user.
5. The method of claim 1, wherein:
- the providing step is carried out with the tissue removing device having an introducer, the introducer being positioned in a lumen of the tubular element; and
- the introducing step is carried out with the introducer positioned in the lumen, the introducer covering the opening and extending beyond a distal end of the tubular element during the introducing step.
6. The method of claim 5, wherein:
- the moving step is carried out with the marker being mounted to the introducer, the introducer moving the marker out of the opening.
7. The method of claim 5, wherein:
- the moving step is carried out the marker being mounted within a recess in the introducer.
8. The method of claim 5, wherein;
- the moving step is carried out with the introducer being naturally biased to move the marker out of the opening.
9. The method of claim 1, wherein:
- the moving step is carried out with the marker being moved out of the opening by fluid pressure.
10. The method of claim 1, wherein:
- the providing step is carried out with the tubular element having a lumen and a marker storage area which holds the marker; and
- the moving step is carried out by moving the marker from the marker storage area and into the lumen and moving the marker through the lumen and out of the opening.
11. The method of claim 10, wherein:
- the introducing step is carried out with an introducer positioned in the lumen, the introducer covering the opening and extending beyond a distal end of the tubular element; and
- the moving step is carried out with the introducer transporting the marker through the lumen and out the opening.
12. The method of claim 1, wherein:
- the providing step is carried out with the marker being stored in a storage area; and
- the moving step is carried out by moving the marker out the storage area, into the lumen and then out the opening.
13-60. (canceled)
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 of claim 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 of claim 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 of claim 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 of claim 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 of claim 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 of claim 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 of claim 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 of claim 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)
Type: Application
Filed: Oct 6, 2005
Publication Date: Oct 5, 2006
Inventors: James Vetter (Portola Valley, CA), Ary Chernomorsky (Walnut Creek, CA), Christopher Daniel (Palo Alto, CA), Mark Clifford (Los Altos, CA), Scott Anderson (Sunnyvale, CA)
Application Number: 11/245,998
International Classification: A61B 10/00 (20060101); A61B 6/00 (20060101); A61B 17/32 (20060101);