Methods and devices for removing tissue from a patient

The present invention is directed to tissue removal devices and methods. A tubular element having an open distal end is advanced into tissue so that tissue enters the tubular element. The tissue which entered the tubular element is cut to separate the tissue from the surrounding tissue. The tissue is then transported proximally by the cutting element or a separate transport element.

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 deformed when moving to a cutting position.

These and other aspects of the present invention shall become apparent from the following description, drawings and claims.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring toFIGS. 1-11, a tissue removing device2according 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. The tissue removal device2has a tubular element4which is advanced into tissue so that tissue is received through an open end6of the tubular element4. A transport element7is positioned within the tubular element4and is used to transport tissue back to a tissue sample chamber30as described below.

The distal end of the tubular element4is beveled to form a sharp tip11but may take any other suitable configuration which penetrates tissue. The tubular element4may also be rotated when driven into the tissue. The tubular element4may be made of any suitable material such as stainless steel. The device2may also include an introducer20positioned in the tubular element4during introduction. The introducer20may have a sharp tip22which penetrates the tissue during introduction of the device2as shown inFIG. 5. The device2may also be introduced through a sheath, trocar or cannula (not shown) which penetrates the tissue rather than using the device2itself 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 the device2may 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 element4may be driven forward a distance of 15-25 mm which may be selected by the user.

The tissue removal device2also has a cutting element10which is used to cut or “part off” tissue which has entered the tubular element4from the surrounding tissue. The cutting element10is stored between the tubular element4and the transport element7and naturally assumes the position ofFIG. 4when advanced. The cutting element10also contacts a protrusion11on an inner surface13of the tubular element4which directs the cutting element10into the cutting position ofFIG. 4. The protrusion11may simply be a ring15of material attached to the inner surface of the tubular element4although any other structure may be used. The transport element4and cutting element10are then moved proximally to the tissue chamber with the cutting element10remaining in the cutting position ofFIG. 4as explained below.

The tissue removal device2has a first actuator24and a second actuator26which are described further below in connection with use of the device2. When the first actuator24is depressed, the introducer20is retracted proximally to the position shown inFIG. 6so that the open end of the tubular element4is exposed to receive tissue. When the second actuator26is depressed, the tubular element4is driven forward so that tissue enters the open end6. The cutting element10is then automatically advanced to part off tissue which has entered the open end10and the transport element7then transports the tissue to the tissue chamber30. The first and second actuators24,26may be knobs, buttons, levers or triggers andFIGS. 1 and 2show the first and second actuators24,26being buttons.

Use of the tissue removal device2is now described in connection withFIGS. 5-11. The device2is introduced into the patient for removal of tissue such as breast tissue in a breast biopsy procedure. The device2is introduced directly into the tissue with the sharp tip22of the introducer20penetrating tissue as shown inFIG. 5. The device2may 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, the first actuator24is depressed to withdraw the introducer20and expose the open end6as shown inFIG. 6. After retracting the introducer20the user may, of course, manipulate the device2as necessary so that the device2is directed toward the tissue to be removed. The introducer20may be withdrawn to a position proximal to the tissue chamber30or another suitable position.

The second actuator26is then depressed which causes the tubular element4to be driven forward so that tissue enters the open end6as shown inFIG. 7. The transport element7may be advanced with the tubular element4or may be driven independently of the tubular element4without departing from the invention. For example, the transport element7may be driven into the position ofFIG. 7after the tubular element4has been driven into the tissue and even after the cutting element10has been deployed to the position ofFIG. 8. The tubular element4may also be rotated while being driven forward, for example, the tubular element4may be rotated 0.5 to 3 revolutions when driven forward. The tubular element4may also simply be translated (without rotating) without departing from numerous aspects of the present invention. The introducer20may be advanced with the tubular element4as shown inFIG. 7.

The cutting element10is then advanced until it contacts the protrusion11and is directed into the tissue which has entered the tubular element4as shown inFIGS. 4 and 8. The cutting element10extends toward and through a longitudinal axis defined by the tubular element4and forms an angle of about 70 degrees with the longitudinal axis although any other suitable angle may be used. The cutting element10, transport element7and/or tubular element4may also be rotated to aid in cutting the tissue. The cutting element10may be rotated with the tubular element4in the same direction or in opposite directions when parting off the tissue which has entered the device2.

The transport element7and cutting element10then move proximally toward the tissue chamber30as shown inFIG. 9. The introducer20is positioned so that continued proximal movement of the transport element7brings the tissue into contact with the distal end of the introducer20as shown inFIG. 10. Continued proximal movement of the transport element7completely exposes the tissue and permits the tissue to fall into the tissue chamber30as shown inFIG. 11. The tubular element4has an opening32leading to the tissue chamber30to permit the tissue to fall into the tissue chamber30when the tubular element4is in the position ofFIG. 11.

The cutting element10is straightened by withdrawing the cutting element10into a recess (not shown). The cutting element10and transport element7are then moved back to the position ofFIG. 6. The tubular element4may remain within the patient during transport of the tissue to the tissue chamber30so that the device2is ready to take another tissue mass without removing the device2from the patient. The user may re-orient the device2as necessary so that the tubular element4is directed at tissue to be removed. The user then actuates the second actuator26again which causes the tubular element4to be driven forward to collect another tissue mass. If a tissue mass is desired at another location, the user may actuate the first actuator24to move the introducer20back to the position ofFIG. 5. The device2may then be manipulated to position the device2at the next location where tissue is to be removed.

Referring toFIGS. 12-18, another device2A for removing tissue is shown wherein the same or similar reference numbers refer to the same or similar structure. The cutting element10A has a first part40and a second part42which may be integrally formed or may be independent elements. The first and second parts40,42move inwardly to cut the tissue which has entered the tubular element4as shown inFIG. 12. The first and second parts40,42move inwardly when they engage a protrusion44on an inner wall46of the tubular element4A as shown inFIG. 12. The protrusion16may be a ring21which directs the first and second parts40,42inwardly.

The first and second parts40,42may each include a portion50which undergoes plastic deformation when moving to the position ofFIG. 12. The first and second parts40,42remain in the closed position until they are withdrawn into recesses (not shown) which straighten the two parts40,42. The first and second parts40,42may also lock together or may be naturally biased to the position ofFIG. 12rather than being plastically deformed without departing from numerous aspects of the present invention.

The cutting element10A is used to transport then tissue to the tissue chamber30after parting off the tissue. The cutting element10A moves proximally as shown inFIGS. 17 and 18to transport the tissue to the tissue chamber30. The tissue may contact the introducer20or another part of the device2A as the tissue is moved proximally to help release the tissue from the cutting element10A.

Use of the device2A is similar to use of the device2described above. The first actuator24is depressed to retract the introducer20as shown inFIG. 14. The second actuator26is then depressed which causes the tubular element4A to be advanced into tissue as shown inFIG. 14. The cutting element10A is then advanced to part off the tissue which entered the open end as shown inFIGS. 12 and 16. The cutting element10A 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 cutting element10A then moves proximally toward the tissue chamber30as shown inFIG. 17and deposits the tissue in the tissue chamber30as shown inFIG. 18. The first and second parts40,42are opened when they are withdrawn into the recesses (not shown).

The tubular element4A and cutting element10are then moved back into position to take another tissue mass. As such, the tissue removal device2does not need to be removed from the patient so that the user may simply reorient the device2or move the device2to another location where tissue is to be removed as described above. The method described in connection withFIGS. 12-18may also be accomplished with the device ofFIGS. 2-11in that the cutting element10may be used to transport the tissue mass by itself. Such a method and use of the device2ofFIGS. 1-11is expressly incorporated here.

Referring toFIGS. 19 and 20, another tissue removal device2B is shown wherein the same or similar reference numbers refer to the same or similar structure. The tissue removal device2B has a tubular element4B which is driven into tissue. The device2B also has the cutting element10which parts off the tissue in the tubular element4B and the tissue chamber30which receives the tissue (seeFIGS. 1 and 2). The cutting element10and/or tubular element4B may be rotated to aid in cutting the tissue. The cutting element10may be rotated with the tubular element4in the same direction or in opposite directions when parting off the tissue which has entered the device2B. The device2B also has the first and second actuators24,26which function in the same manner as the first and second actuators24,26described above (also shown inFIGS. 1 and 2).

The device2B also includes a transport element60which moves within the tubular element4B and engages the tissue. The transport element60may be any suitable element which engages and contacts the tissue mass. For example, the transport element60may be a wire62having a sharp tip64which pierces the tissue. The wire62may be curved or helical so that the wire62may be pivoted or rotated into engagement with the tissue. The transport element60may 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 the transport element60and the tubular element4A are in the position ofFIG. 20, the transport element60moves proximally to carry the tissue toward the tissue chamber30. The transport element60may 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 the introducer20in the manner described above (seeFIG. 11). The transport element60is then withdrawn thereby permitting the tissue mass to fall into the chamber30. The transport element60may be rotated when being withdrawn from the tissue so that the wire62withdraws smoothly from the tissue. The transport element60, tubular element4A and cutting element10are then moved back into position to take another tissue mass without removing the device2B 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 piercing element82which pierces the tissue. The piercing element82also has a deployable anchor83which secures the tissue to the piercing element82. The anchor83may take any suitable form. For example, the anchor83may be one or more retractable barbs84which hold the tissue as shown inFIG. 21. The barbs84may be slightly curved to help hold the tissue on the piercing element80but may take any other suitable shape. The anchor82may also be one or more wires86extending from the piercing element82as shown inFIG. 22or may be an inflatable balloon88as shown inFIG. 23.

The device2C also has the first and second actuators24,26(seeFIGS. 1 and 2) which operate in the manner described above. The device also has a third actuator27which advances the piercing element82when actuated. The piercing element82is then moved proximally after the third actuator27is actuated again as described below to transport the tissue to the tissue chamber30.

The device2C may be operated in a number of different ways including the two now described. In one method, the piercing element82is driven into the tissue before the tubular element4when the user actuates the third actuator27. The tubular element4is then driven over the piercing element82when the user actuates the second actuator26. The piercing element82is then moved proximally to tear the tissue from the surrounding tissue. This step may be performed manually or by actuating the third actuator27again. The tissue is then transported proximally by actuating the third actuator27again if the user has parted-off the tissue manually.

The piercing element82moves proximally until the tissue is over the tissue chamber30at which time the anchor83is automatically released by withdrawing the barbs84or wires86or deflating the balloon88. Further retraction of the piercing element80withdraws the piercing element80completely thereby permitting the tissue to fall into the tissue chamber30as described above in connection with the other devices2,2A,2B. After the tissue has been deposited into the tissue chamber30, the device2C is ready to take another sample without removal from the patient as described above.

In another method of operating the device2C, the tubular element4is driven into the tissue first and the piercing element82is then driven into the tissue after the tissue has entered the tubular element4. The anchor83is then deployed to secure the tissue to the piercing element80. The tissue is then separated from the surrounding tissue and transported to the tissue chamber30as described above.

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.