WO2017040064A1

WO2017040064A1 - Tissue excision device with anchor stability rod and anchor stability rod

Info

Publication number: WO2017040064A1
Application number: PCT/US2016/047720
Authority: WO
Inventors: Martin L. Flatland
Original assignee: SiteSelect Inc.
Priority date: 2015-08-28
Filing date: 2016-08-19
Publication date: 2017-03-09
Also published as: EP3340889A4; EP3340889A1; CA2997004A1

Abstract

An excision device including a guide rod assembly and methods of operating the same are disclosed. An excision device includes a housing coupled to a coring cannula, a stylet with a blade, and a guide rod assembly. A hollow central passageway extends through the center of the excision device. The guide rod assembly is coupled to the housing and includes a guide element having first and second ends and comprised of a guide rod and a locking member. The guide rod is slidably disposed within the central passageway. The locking member is fixed to the second end of the guide rod. The guide rod assembly further includes an anchor stabilization rod slidably disposed within the central passageway. A coupling device, a first portion of which is fixed to the guide rod and a second portion fixed to the anchor stabilization rod, couples the anchor stabilization rod to the guide rod.

Description

TISSUE EXCISION DEVICE WITH ANCHOR

STABILITY ROD AND ANCHOR STABILITY ROD

RELATED APPLICATIONS

[0001] The present application claims the benefit of U.S. Non-Provisional Patent Application Serial No. 14/967,020; filed December 11, 2015, which claims priority to U.S. Provisional Patent Application Serial No. 62/211,256, filed August 28, 2015; this application also claims the benefit of U.S. Non-Provisional Patent Application Serial No. 14/967,032; filed December 11, 2015, which claims priority to U.S. Provisional Patent Application Serial No. 62/211,544, filed August 28, 2015; this application also claims the benefit of U.S. Non- Provisional Patent Application Serial No. 14/967,038; filed December 11, 2015, which claims priority to U.S. Provisional Patent Application Serial No. 62/211,264, filed August 28, 2015; and also claims the benefit of U.S. Non-Provisional Patent Application Serial No. 14/967,058; filed December 11, 2015, which claims priority to U.S. Provisional Patent Application Serial No. 62/211,549, filed August 28, 2015, hereby incorporated by reference in their entirety.

FIELD OF THE INVENTION

[0002] The present invention relates generally to surgical instruments, and more particularly, to a tissue excision device.

BACKGROUND OF THE INVENTION

[0003] Generally, to date there have been two coring type, excisional breast biopsy devices developed and marketed. These devices are described in the following U.S. Patent Nos. 5,111,828; 5,197,484; 5,353,804; 6,080,113; 6,267,732; 6,383,145; 6,551,253; 5,782,775; 5,817,034; 5,857,982; 6,036,657; 6,077,231; 6,165,1406; and 6,213,957, all of which are hereby incorporated by reference.

[0004] These devices were originally developed for use with stereotactic imaging equipment. Generally, these devices use the same basic technology. The typical biopsy' device includes a localization needle with a guide wire preloaded into the device. The localization needle and guide wire are used to locate and localize the target area. The methodology of their usage can be summarized as follows: 1. Localize the target area with needle/wire hook;

2. Translate device up to the target area using a bladed stylet;

3. Core out the target specimen using a bladed cannula; and

4. Transect the tissue using a garrote wire to release the specimen.

[0005] The device can either by a handheld device or may be a fixed device. The below more detailed description of the method of using a prior art device is described with respect to a handheld device.

[0006] First, a localization needle is placed at the center of the target tissue. A localization wire is used to fix the handheld device to the tissue. After the localization wire is deployed, a stylet is manually advanced to a point just proximal of the target.

[0007] One problem associated with the current device is that the localization hook has very little holding power. Another issue related to the prior art devices is the potential of the stylet to push and/or compress, i.e., the tissue in front of the stylet, i.e., "snowplow'.

[0008] After the stylet reaches the target tissue, the cannula is manually advanced over the target tissue. With the cannula advanced over the target tissue, a mechanism, such as a garrote wire is activated to sever the target tissue from the breast. With the target tissue severed from the breast, the device, along with the target tissue with the cannula, may be removed.

[0009] Generally, these prior art devices are purely mechanical devices, i.e., in other words, the coring cannula is advanced by hand. The surgeon or user rotates a knob that activates a gear system to rotate and advances the coring cannula. This results in a relatively slow, intermittent advance of the cannula due to the start/stop motion of the surgeon. The start stop motion can increase patient discomfort, as well as produce an undesirable irregular specimen shape.

[0010] As discussed above, once the cannula has been advanced over the target tissue, a garrote wire may be used to cut the sample tissue (which is inside the cannula) from the breast so that it may be removed. The garrote wire has several limitations. Typically, the garrote wire traverse (at least partially) along the length of the device, then is bent at a 90 degree angle, after which it encircles an inner surface of the coring cannula. The right angle in the garrote wire results in requiring a large amount of force to pull on the garrote wire to transect the tissue sample. Additionally, the garrote wire is generally located a distance behind the cutting edge of the coring cannula This results in a core of tissue which is cored by the coring cannula, which is not transected by the garrote wire, and thus remains in the breast. Furthermore, the garrote wire may tear the tissue rather than cutting the tissue. Additionally, dense tissue can be pushed aside rather than cut.

[0011] Another issue related to prior art designs is the size of the cutting edge of the cannula with respect to the stylet. Prior to entry of the device into the breast, a skin incision is made using a scalpel. This incision is generally just slightly wider than the diameter of the cannula Once the incision is made, the stylet is advanced in the breast, up to the point where the coring blade is ready to enter the incision. At this point, the surgeon will use nerve hooks to grab the skin and open the incision to allow the cutting edge of the cannula to enter the breast. However, the process of using the nerve hooks to grab the skin to make the incision wider can be cumbersome and inefficient and can cause patient discomfort.

[0012] The current devices use a stylet with integral cutting blades. The flat stylet blades are fixed to the stylet which may result in several adverse conditions. First, the close proximity of the cutting edge of the stylet blades to the ramp or stylet tip results in the pushing or compression or other inadvertent movement of the tissue by the stylet. The prior designs also results in a fixed minimal proximal margin equal to the length of the stylet system.

[0013] Improved designs for tissue excision devices and related components include those described in U.S. Patent Nos. 8,597,200, 8,597,201, 8,597,202, 8,597,203, 8,597,204, 8,597,504, 8,529,467, 8,535,240, 8,444,573, 8,529,466, 8,484,988, and 8,740,809.

[0014] In particular, U.S. Patent No. 8,597,204 and U.S. Patent Application Serial No. 14/062,519 disclose use of an independent needle device mat is used to place a tissue anchor at a target area in the breast. Once the tissue anchor is in place, it provides the means to guide the excision device to the target area and perform the excision of a specimen. This method of performing the biopsy enables the user (surgeon) to place the tissue anchor using different methods of visualization, such as MRI, PET, Tomography or ultrasound. The surgeon can choose the best method of visualization based upon the size and type of target tissue. After the tissue anchor has been placed using the preferred method of visualization, the tissue excision device is advanced to the target area using ultrasound guidance.

[0015] The density and consistency of the breast tissue that the tissue anchor is placed into varies greatly. Due to this variety in the tissue, the tissue anchor may migrate or move within the breast during the introduction of the excision device. It is a critical requirement of this excision procedure that the tissue anchor remain at the target area once it is placed. [0016] Another key consideration during the breast excision procedure is the size of the initial incision that is made into the breast. Great efforts are made to minimize the incision size. Reduction to the incision size can benefit patient health with reduced recovery time as well as improved cosmetic results. Currently, the procedure requires that the surgeon make a skin incision that is slightly larger than the diameter of the device cannula A cannula with a 15 mm diameter, for example, would require an initial skin incision of approximately 17-18 mm. There is a need for improved devices and methods for excising an intact tissue specimen of an adequate size through the smallest possible incision.

[0017] An additional key consideration during the breast excision procedure is the size of the initial incision that is made into the breast. Great efforts are made to minimize the incision size. Reduction to the incision size can benefit patient health with reduced recovery time as well as improved cosmetic results. Currently, without using an incision expander, the procedure requires that the surgeon make a skin incision that is slightly larger than the diameter of the device cannula. A cannula with a IS mm diameter, for example, would require an initial skin incision of approximately 17-18 mm. There is a need for improved devices and methods for excising an intact tissue specimen of an adequate size through the smallest possible incision.

[0018] The procedure for excising a breast tissue sample with a handheld excision device is performed with the patient lying on her back. In certain cases, it may be beneficial for the surgeon to compress and support the breast from which the tissue sample is being excised. Compressing the breast may help to immobilize the tissue prior to and during excision of the tissue sample, which may result in a more accurate tissue excision.

[0019] The present invention is aimed at one or more of the problems identified above.

SUMMARY OF THE INVENTION

[0020] A device is disclosed for allowing a surgeon to maintain control of a tissue anchor and prevent movement of the tissue anchor during introduction of an excision device into breast tissue for purposes of tissue excision.

[0021] In a first aspect of the present invention, an excision device is disclosed. The excision device includes a housing coupled to a coring cannula, a stylet with a blade, and a guide rod assembly. A hollow central passageway extends through the center of the excision device. The guide rod assembly is coupled to the housing and includes a guide element having first and second ends and comprised of a guide rod and a locking member. The guide rod is slidably disposed within the central passageway. The locking member is fixed to the second end of the guide rod. The guide rod assembly further includes an anchor stabilization rod slidably disposed within the central passageway. A coupling device, a first portion of which is fixed to the guide rod and a second portion fixed to the anchor stabilization rod, removably couples the anchor stabilization rod to the guide rod.

[0022] In a second aspect of the present invention, a guide rod assembly is disclosed. The guide rod assembly is coupled to the housing and includes a guide element having first and second ends and comprised of a guide rod and a locking member. The guide rod is slidably disposed within a central passageway of the excision device. The locking member is fixed to the second end of the guide rod. The guide rod assembly further includes an anchor stabilization rod slidably disposed within the central passageway. A coupling device, a first portion of which is fixed to the guide rod and a second portion fixed to the anchor stabilization rod, removably couples the anchor stabilization rod to the guide rod.

[0023] In a third aspect of the present invention, a guide rod assembly is disclosed. The guide rod assembly is coupled to the housing and includes a guide element having first and second ends and comprised of a guide rod and a locking member. The guide rod is slidably disposed within a central passageway of the excision device. The locking member is fixed to the second end of the guide rod. The guide rod assembly further includes an anchor stabilization rod slidably disposed within the central passageway. A coupling device, a first portion of which is fixed to the guide rod and a second portion fixed to the anchor stabilization rod, removably couples the anchor stabilization rod to the guide rod. The guide rod assembly further includes a fixed arm support removably coupled to the second end of the anchor stabilization rod.

[0024] In a fourth aspect of the present invention, a method for preventing movement of a tissue anchor of an excision device during tissue excision is disclosed. The method comprises advancing a first end of a guide rod into a target tissue, introducing a first end of an anchor stabilization rod into an excision device, coupling the first end of the anchor stabilization rod to a second end of the guide rod inside the excision device, and controlling movement of the guide rod within the target tissue with a knob coupled to a second end of the anchor stabilization rod. [0025] A device is also disclosed for allowing a surgeon to excise a larger tissue sample through a smaller skin incision than would be possible with traditional excision devices.

[0026] In a fifth aspect of the present invention an excision device is disclosed. The excision device includes a housing, a stylet coupled to the housing and having a tip containing at least one blade, a hollow central passageway extending through the center of the housing and the sty let, a localization needle coupled to the stylet and being slidably disposed within a central passageway, and an expanding cannula. The expanding cannula includes a body having a first end and a second end, the first end coupled to the housing, and an expanding coring mechanism coupled to the second end of the body. The expanding coring mechanism includes an annular spring a plurality of formed fingers extending between the annular spring and the second end of the body, and a retractable flexible blade extending from the second end of the body and over the annular spring.

[0027] In a sixth aspect of the present invention, an expanding cannula is disclosed. An expanding cannula includes a body having first and second ends, the first end coupled to the excision device. The expanding cannula further comprises an expanding coring mechanism coupled to the second end of the body, the mechanism including an annular spring, a plurality of formed fingers extending between the annular spring and the second end of the body, and a retractable flexible blade extending from the second end of the body and over the annular spring.

[0028] In a seventh aspect of the present invention, a method for excising tissue using an expanding cannula is disclosed. The method comprises introducing a bladed stylet coupled to the excision device into a target tissue, retracting the bladed stylet to expose a distal end of an expanding cannula, rotating the expanding cannula using a motor drive to advance the expanding cannula into the target tissue, and collecting a tissue sample.

[0029] In an eighth aspect of the present invention, a method for excising tissue using an expanding cannula is disclosed. The method comprises introducing a bladed stylet coupled to the excision device into a target tissue, retracting the bladed stylet to expose a distal end of an expanding cannula, rotating the expanding cannula using a motor drive to advance an expanding coring mechanism into the target tissue, collecting a tissue sample with the expanding coring mechanism, and retracting the expanding cannula from the target tissue. [0030] Devices and methods are disclosed for allowing a surgeon to introduce an excision device with a larger diameter through a smaller skin incision than would otherwise be possible with traditional excision devices.

[0031] In a ninth aspect of the present invention, an incision expander with removable stylet is disclosed. An incision expander includes a housing, an expanding cannula coupled to the housing, a mechanism to expand the expanding cannula coupled to the housing and the expanding cannula, and a removable bladed stylet extending through the center of housing and the expanding cannula.

[0032] In a tenth aspect of the present invention, an incision expander with tapered stylet is disclosed. An incision expander includes a housing, a cannula coupled to the housing, and a tapered stylet extending through the center of housing and the cannula

[0033] In an eleventh aspect of the present invention, a method for introducing an excision device through an incision is disclosed. A bladed stylet is introduced into a target tissue. The bladed stylet extends through the center of an incision expander. The incision expander comprises a housing and an expanding cannula A mechanism to expand the expanding cannula is actuated. The bladed stylet is retracted from the incision expander. An excision device is introduced into the target tissue through the center of the incision expander.

[0034] In a twelfth aspect of the present invention, a tissue excision system is disclosed. The system includes an excision device having a housing coupled to a coring cannula, a bladed stylet coupled to the housing, a hollow central passageway extending through the center of the housing, the coring cannula, and the stylet, and a guide rod assembly removably coupled to the housing. The system further includes an incision expander coupled to the excision device and having a housing, an expanding cannula coupled to the housing, a mechanism coupled to the housing and the expanding cannula and being configured to expand the expanding cannula, wherein the bladed stylet extends through the center of the housing of the excision expander and the expanding cannula

[0035] Devices and methods are disclosed for allowing a surgeon to compress and support a breast from which a tissue sample may be excised.

[0036] In a thirteenth aspect of the present invention, a breast compression device is disclosed. The breast compression device comprises a back plate, a front paddle comprising two or more fingers, and an adjuster to adjust the space between the back plate and the front paddle. [0037] In a fourteenth aspect of the present invention, a breast compression device is disclosed. The breast compression device comprises a back plate, a front paddle comprising two or more fingers, and a bar connecting the back plate and the front paddle.

[0038] In a fifteenth aspect of the present invention, a method for compressing breast tissue with a breast compression device is disclosed. The breast compression device is wrapped around the breast tissue from any angle. The breast compression device includes a back plate, a front paddle comprising two or more fingers, and a bar connecting the back plate and the front paddle. The breast compression device is adjusted to provide enough compression to render the breast tissue immobile.

[0039] In a sixteenth aspect of the present invention, a tissue excision sy stem is disclosed. The system includes an excision device and a breast compression device. The excision device includes a housing coupled to a coring cannula, a stylet coupled to the housing and having a bladed tip, a hollow central passageway extending through the center of the housing, the coring cannula, and the stylet, and a guide rod assembly removably coupled to the housing. The breast compression device includes a back plate, a front paddle with two or more fingers, and an adjuster to adjust the space between the back plate and the front paddle. The bladed stylet is advanced to a target tissue between the two or more fingers of the front paddle of the compression device.

BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Other advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings wherein:

[0041] Figure 1 is a drawing of a biopsy device with an integrated needle, according to an embodiment of the present invention;

[0042] Figures 2A-2D include a series of views of the biopsy device of Figure 1 illustrating operation thereof;

[0043] Figure 3 is an isometric drawing of a biopsy device with an independent needle assembly, according to an alternative embodiment of the present invention;

[0044] Figure 4A is a drawing of the independent needle assembly of Figure 3;

[0045] Figure 4B is another drawing of the independent needle assembly of Figure 3; [0046] Figure 5A is a drawing of a guide element of the independent needle assembly of Figures 3 and 4;

[0047] Figure 5B is a larger view of a portion of Figure 5A;

[0048] Figure 6 is an isometric illustration of a handheld breast biopsy device having a housing and a handle, according to an embodiment of the present invention;

[0049] Figure 7 is a cut-away view of the handle of a breast biopsy device, according to an embodiment of the present invention;

[0050] Figure 8 is a first cut-away view of a breast biopsy device illustrating the drivetrain components, according to an embodiment of the present invention;

[0051] Figure 9 is a second cut-away view of the breast biopsy device of Figure 8;

[0052] Figure 10 is a drawing of the housing, according to an embodiment of the present invention;

[0053] Figure 11 is a drawing of the stylet, according to an embodiment of the present invention;

[0054] Figure 12 a drawing of the cannula, according to an embodiment of the present invention;

[0055] Figure 13A is an illustration of a guide element of an independent needle assembly, according to a first embodiment of the present invention;

[0056] Figure 13B is an illustration of a partial view of the independent needle assembly of Figure 13 A, in the unlocking configuration;

[0057] Figure 13C is an illustration of a partial view of the independent needle assembly of Figure 13 A, in the locking configuration;

[0058] Figure 14 is an illustration of a guide element according to a second embodiment of the present invention, in the unlocking configuration;

[0059] Figure 15 is an illustration of the guide element of Figure 14A in the locking configuration;

[0060] Figure 16A is an illustration of a guide element according to a fourth embodiment of the present invention;

[0061] Figure 16B is a front view of the guide element of Figure 16A in the unlocking configuration;

[0062] Figure 16C is a side view of the guide element of Figure 16A in the unlocking configuration; [0063] Figure 16D is a side view of the guide element of Figure 16A in the locking configuration;

[0064] Figure 17 is a side view of a guide element according to a fifth embodiment of the present invention;

[0065] Figure 18 is a side view of a guide element according to a sixth embodiment of the present invention;

[0066] Figure 19A is an illustration of a partial view of an integrated needle assembly with a guide element in the unlocking configuration, according to an embodiment of the present invention;

[0067] Figure 19B is an illustration of the integrated needle assembly of Figure 19A with the guide element in the locking configuration;

[0068] Figure 19C is an illustration of the integrated needle assembly of Figure 19A with two three wires of the guide element retracted into the localization needle;

[0069] Figure 19D is an illustration of a part of the guide element with a single wire which remains in the target tissue to provide orientation of the sample;

[0070] Figure 20A is a partial side view of a coring cannula in an initial position and a final position, according to an embodiment of the present invention;

[0071] Figure 20B is a front view of the coring cannula of Figure 20A;

[0072] Figure 21 A is a partial side view of the coring cannula of Figure 20B during initial advanced of a flexible transection blade;

[0073] Figure 2 IB is a front view of the coring cannula and flexible transection blade of Figure 21 A;

[0074] Figure 22A is a partial side view of the coring cannula and flexible transection blade in a second blade position;

[0075] Figure 22B is a front view of the coring cannula flexible transection blade in the second blade position;

[0076] Figure 23A is a view of the flexible transection blade in an initial configuration, according to an embodiment of the present invention;

[0077] Figure 23B is a top view of the flexible transection blade in a cutting configuration, according to an embodiment of the present invention;

[0078] Figures 23C is a front view of the flexible transection blade in the cutting configuration showing a cutting edge, according to an embodiment of the present invention; [0079] Figure 24 is a graphical representation of the drivetrain of the device and the flexible transaction blade in the initial position, according to a first embodiment of the present invention;

[0080] Figure 25A is a graphical representation of the drivetrain of the device and the flexible transaction blade, of Figure 24, in the final position;

[0081] Figure 25B is a front view of the graphical representation of the drivetrain of the device and the flexible transaction blade, of Figure 24, in the final position;

[0082] Figure 26 is a graphical representation of the drivetrain of the device and the flexible transaction blade in the initial position, according to a second embodiment of the present invention;

[0083] Figure 27 is a graphical representation of the drivetrain of the device and the flexible transaction blade, of Figure 24, in the final position;

[0084] Figure 28A is a first cut away view of the graphical representation of the drivetrain of the device and the flexible transaction blade, of Figure 24, in the final position;

[0085] Figure 28B is a second cut away view of the graphical representation of the drivetrain of the device and the flexible transaction blade, of Figure 24, in the final position;

[0086] Figure 29 is a graphical representation of an alternative drivetrain, according to an embodiment of the present invention;

[0087] Figure 30 is a graphical representation of a second alternative drivetrain in an initial position, according to an embodiment of the present invention;

[0088] Figure 31 is a graphical representation of the second alternative drivetrain in a final position;

[0089] Figure 32A is a graphical representation of a flexible transection blade and a coring cannula with a circular cutting ring, according to an embodiment of the present invention;

[0090] Figure 32B is a front view of the flexible transection blade and coring cannula of Figure 32A;

[0091] Figure 33A is a graphical representation of a flexible transection blade and a coring cannula with a partial cutting ring, according to an embodiment of the present invention;

[0092] Figure 33B is a front view of the flexible transection blade and coring cannula of Figure 33A;

[0093] Figure 34A is a graphical representation of a flexible transection blade which forms the cutting edge of the coring cannula, according to an embodiment of the present invention; [0094] Figure 34B is a front view of the flexible transection blade and coring cannula of Figure 34A;

[0095] Figure 35 is a graphical representation of a prior art coring cannula with an internal cutting ring;

[0096] Figure 36A is a graphical representation of a coring cannula with an angled cutting ring, according to an embodiment of the present invention;

[0097] Figure 36B is a front view of the coring cannula and cutting ring of Figure 36A;

[0098] Figure 406A is a first view of a garrote wire for use with the cutting ring of Figures 36A and 36B;

[0099] Figure 406B is a second view of a garrote wire for use with the cutting ring of Figures 36A and 36B;

[00100] Figure 406C is a third view of a garrote wire for use with the cutting ring of Figures 36A and 36B;

[00101] Figure 38A is a graphical representation of a coring cannula with an external cutting ring, according to an embodiment of the present invention;

[00102] Figure 38B is a view of a portion of the coring cannula and external cutting ring of Figure 38 A;

[00103] Figure 39 is a graphical representation of a coring cannula with an external cutting ring, according to an other embodiment of the present invention;

[00104] Figure 40 is a graphical representation of a prior art coring cannula with a cutting ring;

[00105] Figure 41 is a graphical representation of a coring cannula with a cutting ring, according to an embodiment of the present invention;

[00106] Figure 42A is a side view of a prior art coring cannula and stylet;

[00107] Figure 42B is a front view of the prior art coring cannula and stylet of Figure

42A;

[00108] Figure 43A is a side view of a coring cannula and a collapsible stylet in an initial configuration, according to an embodiment of the present invention;

[00109] Figure 43B is a first front view of the coring cannula and stylet of Figure 43 A;

[00110] Figure 43C is a side view of the coring cannula and stylet of Figure 43A in a contracted configuration; [00111] Figure 43D is a second front view of the coring cannula and stylet of Figure 43A with the stylet in the contracted configuration;

[00112] Figure 44 is a view of a prior art stylet;

[00113] Figure 45 is a view of a stylet including an independent stylet mechanism, according to an embodiment of the present invention;

[00114] Figure 46A is a first view of an expanding localization needle, according to an embodiment of the present invention;

[00115] Figure 46B is a second view of the expanding localization needle of Figure 46A;

[00116] Figure 46C is a view of the expanding localization needle of Figure 46A with an actuation mechanism, according to a first embodiment of the present invention;

[00117] Figure 46D is a view of the expanding localization needle of Figure 46A with an actuation mechanism, according to a second embodiment of the present invention;

[00118] Figure 47 A is a first view of an expanding localization needle, according to an other embodiment of the present invention;

[00119] Figure 47B is a partial view of the expanding localization needle of Figure 47A;

[00120] Figure 48A is a first view of a stylet with a rotating blade, according to an embodiment of the present invention;

[00121] Figure 48B is a second view of the stylet with the rotating blade of Figure 48A;

[00122] Figure 49 is an illustration of a stylet with multiple rotating blades, according to an embodiment of the present invention;

[00123] Figure 50A is a graphical representation of a portion of a breast biopsy device with a garrote wire and a trigger mechanism includes a pair of cleats;

[00124] Figure SOB is a second graphical representation of the breast biopsy device of Figure 5A;

[00125] Figure 50C is a third graphical representation of the breast biopsy device of Figure 50A;

[00126] Figure 50D is a fourth graphical representation of the breast biopsy device of Figure 50A; [00127] Figure 51 A is a graphical representation of another embodiment of the trigger mechanism of Figure 50A;

[00128] Figure 51 B is a graphical representation of a further embodiment of the trigger mechanism of Figure 50A;

[00129] Figure 52A is a top view of a graphical representation of a top view of a breast biopsy device having a rotatable trigger, according to an embodiment of the present invention;

[00130] Figure 52B is a side view of the breast biopsy device of Figure 52A;

[00131] Figure 52C is a second view of the breast biopsy device of Figure 52A; and

[00132] Figure 52D is a third view of the breast biopsy device of Figure 52A.

[00133] Figure 53 is an isometric view of an exemplary guide rod assembly;

[00134] Figure 54 is a side view of an exemplary excision device with anchor stabilization rod;

[00135] Figure 55 is a partial isometric view of an anchor stabilization rod and a guide rod including a hook-and-loop coupling device;

[00136] Figure 56 is a partial isometric view of an anchor stabilization rod and a guide rod including a notched coupling device;

[00137] Figure 57 is a partial isometric view of an anchor stabilization rod and a guide rod including a wireform attachment coupling device;

[00138] Figure 58 is an isometric view of an exemplary excision device with an anchor stabilization rod and fixed support arm is shown;

[00139] Figure 59 is a partial isometric view of an expanding cannula;

[00140] Figure 60 is a partial isometric view of a partially expanded expanding cannula;

[00141] Figure 61 is a partial isometric view of a fully expanded expanding cannula;

[00142] Figure 62 is an isometric view of an assembled incision expander according to a first embodiment;

[00143] Figure 63 is an isometric view of a disassembled incision expander; and

[00144] Figure 64 is an isometric view of an incision expander with bladed stylet removed and expanded cannula in an expanded state;

[00145] Figure 65 is an isometric view of an assembled incision expander according to a second embodiment. [00146] Figure 66 is an isometric view of a breast compression device;

[00147] Figure 67 is a top view of a breast compression device according to a second embodiment;

[00148] Figure 68 is a top view of a breast compression device according to FIG. 54 illustrating compression of a breast;

[00149] Figure 69 is a front view of a breast compression device according to FIG. 54 illustrating compression of a breast; and

[00150] Figure 70 is a top view of a breast compression device with a partial side view of a biopsy device.

DETAILED DESCRIPTION OF INVENTION

[00151] Referring to the Figures, wherein like numerals indicate like or corresponding parts throughout the several views, the present invention provides a device and method for allowing a surgeon to maintain control of a tissue anchor and prevent movement of the tissue anchor during introduction of an excision device into breast tissue for purposes of tissue excision.

[00152] An exemplary breast biopsy device 10 and a method of operating the breast biopsy device 10 are disclosed herein. With reference to Figure 1, in one aspect of the present invention, the breast biopsy device 10 is embodied in a handheld device 12. It should be noted that the present invention may be embodied in a fixed device (not shown).

[00153] The handheld device 12 may include a housing 14 (see Figure 10) and a handle 16. In one aspect, the housing 14 is removable from the handle 16. The handle 16 is reusable. The housing 14 (and all parts contained therein) are disposable and generally provided sterile. In one aspect of the present invention, the device 10 may include an integrated needle assembly 18 (described below). In another aspect of the present invention, the device 10 may include an independent needle assembly 18' (described below).

[00154] With particular reference to Figures 10, 11 and 12, the housing 14 may include an inner passage 22 (see Figure 10). A coring cannula 20 is slidably mounted within the inner passage 22 of the housing 14. The coring cannula 20 has a longitudinal axis 24 and may include a shaft 26 centered on the axis 24.

[00155] In one embodiment, the coring cannula 20 is coupled to the housing such mat rotational movement of the coring cannula 20 about the axis 24 results in linear movement of the coring cannula 20 along the axis 24. As discussed more fully below, the coring cannula 20 has a cutting edge allowing it to cut through tissue as it is rotated and advanced.

[00156] It should be noted that in other embodiments, the coring cannula 20 may simply rotate within the housing 14. Linear movement of the coring cannula 20 (to advance the device 10 and the coring cannula 20 into the breast) may be provided by external mechanical means or by the user.

[00157] The breast biopsy device 10 includes a stylet 28, which includes a stylet housing 38. With particular reference to Figure 11, the stylet includes a tip 30. The tip 30 includes at least one blade 32 and a central passage 34. The tip 30 may also include a slot 31 for the at least one blade 32.

[00158] In one embodiment of the present invention, the stylet 28 is mounted within the coring cannula 20. The stylet 28 includes first and second blades 32A, 32B integrated between two half portions 38A, 38B of a stylet housing 38. The stylet 28 transects, dilates, and separates tissue as the device 10 is inserted or advanced towards the biopsy site.

[00159] A drive assembly 40 mounted within the housing 14 and the handle 16 (see Figures 7 and 9) rotates the cannula 20 and controllably rotates the cannula 20. In one embodiment, the drive assembly 40 also moves the cannula 20 in a direction parallel to (and along) the axis 24. In one aspect, the coring cannula 20 has a predetermined linear advancement per revolution of the coring cannula 20. In one embodiment, the predetermined linear advancement is 0.050 inches per revolution. In an other embodiment, the predetermined linear advancement is 0.084 inches per revolution.

[00160] The drive assembly 40 may include a motor assembly comprised of a DC motor and step down transmission 42 and a drivetrain 44. The DC motor and step down transmission 42 is coupled to the drivetrain 44 (Figure 9). The drive assembly 40 and the drivetrain 44 are explained more fully below.

[00161] In one aspect of the present invention, the drive assembly 40 rotates the coring cannula 20 as a single speed, for example, at or around 80 revolutions per minute. Alternatively, the drive assembly 40 rotates the coring cannula 20 at a variable speed (see below).

[00162] The needle assembly 18, 18' may include a localization needle 54. The localization needle 54 has an inner channel 56 and is slidably removable from the central passage of the stylet 28. The needle assembly 18, 18' further includes a guide element 52 (see Figures 4 and 5A). The guide element 52 is used to secure the tissue while the coring cannula 20 is advanced.

[00163] In one embodiment of the present invention, the guide element 52 has a first end 58 and a second end 60. The first end 58 of the guide element 52 is slidably disposed within the channel 56 of the localization needle 54.

[00164] In one embodiment, the guide element 52 is composed, at least in part, of a metal alloy. In one embodiment, the metal alloy is composed of nickel and titanium In one embodiment, the metal alloy is nitinol.

[00165] A locking member 62 is formed at the second end 60 of the guide element 52. The locking member 62 has an unlocking configuration and a locking configuration. The locking member 62 is in the unlocking configuration when the guide element 52 is in the first position, i.e., fully contained within the localization needle 54 (see Figure 13B). The locking member 62 is in the locking configuration when the guide element 52 is in the second position, i.e., then the locking member 62 is outside of the localization needle 54 (see Figure 13C). In the illustrated embodiment, the locking wire 62 is formed of multiple wires 64, e.g., two, which are predisposed toward the locking configuration. When the guide element 52 is slid back into the localization needle 54, the inner channel 56 of the localization needle 54 constrains and confines the wires 64 in the unlocking configuration. Once the guide element 52 is slid towards and into the second position, the wires 64 are freed from the constraints on the localization needle 54 and allowed to move toward and into the locking configuration.

[00166] In one aspect of the present invention, the locking configuration is defined by a predefined shape of the wires 64. In one embodiment, the predefined shape is a hook shape.

[00167] In one embodiment, wires (not shown) may be wrapped around the wires 64 to provide rigidity to allow the guide element 52 to be moved within the localization needle 54. The number of wires 64, as well as the diameter of the wires 64 (and wires used to provide rigidity) is optimized to provide maximize holding and as a function of the type of targeted tissue, e.g., hard or soft tissue.

[00168] With reference to Figures 14 and 15, in another embodiment of the present invention, the locking member 62 may include a twisted pair of wires 66. The guide element 52 is shown in the first position in Figure 14 with the twisted pair of wires 66 in the unlocking configuration. The guide element 52 is shown in the second position in Figure IS with the twisted pair of wires 66 in the locking configuration.

[00169] With reference to Figures 16A, 16B, 16C, and 16D, in another embodiment of the present invention, the locking member 62 is formed from braided wi re or cable 68. As shown, in one embodiment, the distal ends of the cables may be straightened and then formed into a predetermined shape, such as a hook shape. The number of wires or cables may vary, e.g., the braided wire or cable may include 4, 7 or any number of individual wires or cables. The guide element 52 is shown in the first position in Figure 16C with the braided cable 68 in the unlocking configuration. The guide element 52 is shown in the second position in Figure 16D with the braided cable 68 in the locking configuration.

[00170] With reference to Figures 17 and 18, in another embodiment, the guide element 52 may include a pushrod 70 and at least two flexible fingers 72A, 72B. In one embodiment, the pushrod 70 and flexible fingers 72 A, 72B are unitarily formed (Figure 17). In another embodiment, the flexible fingers 72A, 72B are affixed to the pushrod 70 (Figure 18).

[00171] In one aspect, the flexible fingers 72A, 72B may be predisposed towards the locking configuration through a heat treat process.

[00172] Returning to Figures 7 and 9, in one embodiment of the present invention, the drive assembly 40 may include a variable speed circuit 74 electrically coupled to the motor assembly 42, 44. A forward/reverse switch 76 is electrically coupled to the variable speed circuit 74. A speed control trigger 78 is electrically coupled to the variable speed circuit 74. The forward/reverse switch 76 controls the direction of the DC motor 42, and thus, the direction of movement (forward/reverse) of the cannula 20 along the axis 24.

[00173] The variable speed circuit 74 controls the speed and rotation of the cannula 20 as a function of the forward/reverse switch 76 and actuation of the speed control trigger 78. In one aspect, the variable speed circuit 74 has a predetermined speed range, for example 0- 100 revolutions per minute.

[00174] The DC motor and transmission 42 is powered by a rechargeable battery 46, which may be charged via an external power source (not shown) through recharging port 48. In one embodiment, the rechargeable batter}' 46 is a lithium ion batter}'. [00175] The DC motor and transmission 42 is used to provide low speed and high torque to the drivetrain 44. A drive gear 50 is directly coupled between the motor 42 and the drivetrain 44.

[00176] With specific reference to Figures 7, 8, and 9, the drivetrain 44 may include a spline gear 80, a spline gear support 82, a lead screw 84, a shaft 86, and a ring gear transmission 88. The spline gear 80 is contained with the housing 14 and is supported by the spline gear support 82. The drive gear SO engages the spline gear 82 to transfer power to the drivetrain 44, and thus, the coring cannula 20.

[00177] The speed of the DC motor 42 is controlled by user actuation of the speed control trigger 78. The variable speed circuit 74 enables variable speed ramp up and slow down. In one embodiment, a speed range of approximately 0 -100 rpm at the cannula may be provided.

[00178] The drivetrain 44 is contained within the housing 14, which is removable coupled to the handle 16. When the device 10 is assembled, the spline gear 80 engages the drive gear 50 within the handle 16. Power transferred through the drive gear 50 causes rotation of the spline gear 80. The spline gear 80 is attached to the spline gear support 82. The spline gear support 82 is keyed to the shaft 86. The spline gear support key 82 provides rotation to the shaft 86 while allowing it to move axially (along axis 24). The lead screw 84, which is fixed to the housing 14, is engaged with threads at the proximal end of the shaft 86. The coring cannula 20 is attached to the shaft 86. As the shaft 86 is rotated, the threaded engagement with the lead screw 84 creates axial movement of the coring cannula 20.

[00179] As the cannula 20 rotates, it continues to move forward for a distance determined by the thread length on the lead screw 84. As the shaft 86 reaches the end of the threads, it will continue to rotate, but will no longer move forward. The timing is designed such that when the shaft 86 reaches the end of the threaded section of the lead screw 84, the transmission lockout (lock out button 90) engages. With the lock out button 90 engaged, the ring gear assembly 88 is activated and begins to advance a drive dog 92 forward along the drive screw 50.

[00180] The drive dog 92 is coupled to a severing mechanism 94 which is used to sever the tissue contained within the coring cannula 20, which is described more fully below.

[00181] The general process of utilization of the device will now be described. First, the localization needle 54 is advanced into the breast under ultrasound guidance. In one aspect of the present invention, this is performed manually. For instance, with the handheld device 10, the user manually inserts the needle 54 by positioning and manually moving the device 10. When the needle 54 reaches the target area, the tissue anchor or locking member 62 is advanced to secure the tissue prior to advancement of the device 10. Next, the localization needle 54 is released allowing the device 10 to move independently of the needle 54. The device 10 is now advanced into the breast, with the stylet blades 32 separating the tissue up to the target area. When the device 10 has reached the target area, the coring cannula 20 is advanced. The cannula 20 is advanced by depressing the speed control trigger 78 on the handle 16, with the forward/reverse switch 76 in a forward position. When the cannula 20 reaches its full core length, the severing mechanism 94 is actuated, separating the tissue core from surrounding tissue. In one embodiment, the severing mechanism 94 may include a flexible blade (see below) will automatically advance from the distal end of the coring cannula 20. After the core of tissue has been cut free, the device 10 is removed from the breast. With the device out of the breast, the forward/reverse switch 76 is placed in a reverse position and the flexible blade is retracted using the speed control trigger 78 allowing the tissue sample to be retrieved from the coring cannula

[00182] As stated above, in one aspect of the present invention, an integrated needle assembly 18, as shown in Figure 1 and demonstrated in Figures 2 A, 2B, 2C, and 2D, may be provided. With the integrated needle assembly 18, the needle assembly 18 and the coring cannula are integrated into a single unit 18, 20 (see Figure 2A). With the integrated needle assembly 18, the needle assembly 18 is inserted within the central passage 34 of the stylet housing 38 when the localization needle 54 is inserted into the breast (Figure 2B). Once the localization needle 54 reaches the target tissue, a locking member actuation button 96, located on the top of the housing 14 is slid forward. The actuation button 96 is linked to the locking member 62 resulting in the locking member 62 being slid out of the localization needle 54 securing the target tissue.

[00183] Once the target tissue is secured, the localization needle 54 and locking member 82 are released from the housing 14 by actuation of one of the localization needle release button(s) 98 located thereon. This allows the device 10 to be slid up localization needle 54 (the stylet blades 32 separating the tissue allowing the stylet 28 and coring cannula 20 to pass. Once the coring cannula 20 is adjacent the target tissue, the process proceeds as above. [00184] Then, the device 10 would be fed down the guide rod 104 and the process would proceed as above (see Figure 5A).

[00185] With respect Figure 5B, the central passage 34 is formed by the stylet tube 36. The stylet tube 36 includes an opening 106 which allows the needle assembly 18, 18B' to pass into the central passage 34. The stylet tube 36 also may include a guide portion 108 which extends past the opening 106 to assist in the placement of the guide rod into the central passage 34.

[00186] In another aspect of the present invention, an independent needle assembly 18' may be provided (see Figures 3, 4 A, 4B, 5 A, 5B). The independent needle assembly 18' is separate from the coring cannula 20. The independent needle assembly 18' includes a localization needle 54', an independent needle handle 100, and a plunger 102. The localization needle 54' is inserted into the breast tissue using the handle 100. Once the target tissue is reached, the plunger 102 is pushed forward. The locking member 62 is pushed forward by the plunger 102, pushing the wires 64 into the target tissue, thereby securing the target tissue. The localization needle 54' (and handle 100), may thereafter be removed, leaving the locking member 62 within the breast with a guide rod 104 extending out of the breast (see Figure 4B).

[00187] The localization needle 54' has a first end 54 A' and a second end 54'. The localization needle includes an internal channel or bore 56. The handle 100 has first and second ends 100 A, 100B and an internal bore 268. The first end 54A of the needle 54' is fixed to the second end of the handle 100B. The internal bore 56 of the needle 54' and the internal bore 268 of the handle 100 form an assembly bore 270 therethrough. In the illustrated embodiment, the guide element 52 has a guide rod 104 and a locking member 62. The guide element 104 has first and second ends 58, 60 and is removably contained within the assembly bore 270. The locking member 62 is fixed to the second end 60 of the guide rod 104. The plunger 102 includes a pushrod 102B and an actuation element 102A coupled to the pushrod 102B. The plunger 102A is movable from a first state (Figure 4A) to a second state (Figure 4B) One end of the pushrod 102B acts on the first end 58 of the guide rod 104, forcing the locking member 62 out of the needle 18' as the pushrod 102 is moved from the first state to the second state.

[00188] With reference to Figures 19A-19D, in one embodiment one of the wires 64' from the locking member 62 is detachable from the pushrod 70. It should be noted that although Figures 19A-19D illustrated this feature with respect to the independent needle assembly 18, the detachable wire 64' concept may also be used with the integrated needle assembly 18'.

[00189] As shown in Figure 19 A, the locking member 62 is contained within the localization needle 54 when the localization needle is initially inserted into the breast tissue. When the localization needle 54 reaches the target tissue, the locking member 62 is deployed as discussed above (Figure 19B) to secure the target tissue. Then the cannula 20 is advanced over the target tissue and severed using the severing mechanism 94 (see above). Once the device 10 has been removed from the breast, the localization needle 18' may be used to push the severed tissue from the cannula 20. The tissue anchors or wires 64 may then be retracted. The third hook 64' may either not be attached to the pushrod 70 or may be detachable therefore. The third hook or wire 64' remains attached or secured to the tissue to provide an orientation marker for the sample during pathology (see Figure 19D).

[00190] In another aspect of the present invention, the guide rod 104 may include scale markings 110 to provide an indication to the user the depth of the anchor/guide element 52 within the breast, as shown in Figures 13A and 19B.

[00191] In another aspect of the present invention, the biopsy device 12 includes a flexible transection blade 112. The flexible transection blade 112 is a flat metal blade wi th one end sharpened is formatted to the required radius (see below). The blade thickness and material properties as such that the formed flexible transection blade 112 can be flattened out wi ll "spring" back to its formed shape. The blade 112 will be held in a flat position along the side of the coring cannula.

[00192] The coring cannula 20 will use an angled or non-continuous cutting ring (see below) at the completion of the coring process. As shown in Figures 20A and 20B, the coring cannula 20 is movable along the axis 24 from an initial cannula location 118 (shown in dotted lines) to a final cannula location 120 in response to rotation of the coring cannula 20 about the axis 24 in a first direction.

[00193] In one embodiment, once the coring cannula 20 reaches the final cannula location 120, it will continue to rotate but will not advance axially forward. A mechanism 122 will be engaged to drive the flexible transection blade 112 forward. The flexible transection blade 112 exits the coring cannula 20 at a point slightly distal to the cutting edge of the coring cannula 20 (see Figures 21 A and 21B). As the flexible blade 112 is driven out of the cannula 20, it will begin to return to its pre-formed curvature. Since this advancement is taking place while the coring cannula 20 is rotating, the result will be a curved, complete cut through the tissue. The path of the blade 112 is designed to intersect with the distal end of the cutting path from the coring cannula 20, resulting in complete transection and release of the tissue specimen.

[00194] With reference to Figures 23 A, 23B, and 23C, in one embodiment the flexible transection blade 112 consists of a thin strip 124 of spring steel or nitinol. The flexible transection blade 112 has a first end 126 and a second or distal end 128. The flexible transection blade 112 is coupled to the coring cannula 20 at the first end 126. The distal end 128 of the flexible transection blade 112 is cut to an optimized angle and sharpened to a cutting edge 114 (see Figure 23C). A hole mount 130 may be provided for mounting the blade 112 to the drive assembly 40.

[00195] In one embodiment as shown in Figures 8 and 9, the flexible transection blade 112 is stored in a channel 116 built into the coring cannula 20. The flexible transection blade 112 is held flat in this stored position. At the completion of the coring process, the coring cannula 20 will cease axial advancement, but will continue to rotate. During this rotation the flexible blade 112 is driven forward, advancing past the coring cannula 20. As the flexible blade 112 advances, it will assume its pre-formed, curved position. Rotation causes the flexible blade 112 to create a semi-circular cut in the tissue. When the flexible transection blade 112 advances past the center of rotation, a complete cut results, releasing the tissue core. The curved blade 112 holds the tissue core inside the cannula 20 until removed from the breast.

[00196] The flexible transection blade 112 has a first blade position and a second blade position. The flexible transection blade 112 is in the first blade position while the coring cannula 20 is between the initial and final cannula locations 118, 120. As shown in Figure 20 A, in one embodiment, when the flexible transection blade 112 is in the first blade position it is contained within the coring cannula 20, and thus, not visible. Rotation of the coring cannula 20 in the first direction while the coring cannula 20 is at the final cannula location 120 rotates the flexible transection blade 112 about the axis 24, moving the flexible transection blade 112 from the first blade position to the second blade position (shown in Figure 22B). [00197] Testing has revealed a few key elements of the invention. First, the most efficient cutting of tissue is accomplished by creating relative motion between cutting surface, i.e., the cutting edge 114, and tissue. Second, the relationship between the cutting edge 114 and the rate of advancement of the length and angle of the cutting edge 114 must result in a cutting surface that is greater in length than the linear advancement per revolution. Further, the rate of advancement per revolution should be optimized to minimize cutting forces. This approach will ensure that a thin, flexible blade 112 will follow the desired cutting path.

[00198] With particular reference to Figures 24, 25 A, and 25B, in one embodiment the mechanism 122 may include a friction wheel transmission 132. The friction wheel transmission 132 includes friction wheel 134 which is force fit over the shaft 26. The shaft 26 is directly coupled to the cannula 20 through a drive ring 20 which is fixed to the housing 14. A drive screw 136 is fixed to the friction wheel 134, which is coupled to the flexible transection blade 112. As the shaft 26 is advanced by the drive assembly 40, the friction wheel 134, and thus the flexible transection blade 116 is also advanced. The friction wheel 134 is force fit over the shaft 26 such that the transmission force may be controlled. The relationship between the friction wheel 134 and the drive ring 136 and/or the relationship between the friction wheel 134 and the shaft 26 can be adjusted so that if the force encountered by the flexible transection blade 112 increases to a certain point, the friction wheel 134 will slip on the shaft 26 preventing further advancement of the blade 112. The blade 112 will continue to rotate until the sample tissue has been cut and the forces reduced. Blade advancement will then automatically resume.

[00199] With particular reference to Figures 26, 27, and 28, in another embodiment the mechanism 122 may include a gear drive transmission 140. The gear drive transmission 140 provides continuous drive with maximum power transfer. In one aspect of the present invention, the gears within the gear drive transmission 140 remain meshed but do not rotate during axial advancement of the coring cannula 20. When advancement of the coring cannula 20 is complete, the gear drive transmission 140 automatically engages and begins to drive the flexible transection blade 112.

[00200] The gear drive transmission 140 may include a gear housing 146, a ring gear 150, and a drive gear 152. A plunger 144 is slidably coupled to the gear housing 146 and is spring biased in an outward direction. While the coring cannula 20 is between the initial cannula location 118 and the final cannula location 120, plunger 144 is pressed inwardly by the inner wall of the housing 20 such that one end is inserted a receiving slot 148 on the shaft 26. Thus, the gear housing 146 is locked relative to the shaft 26. The shaft gear housing 146 thereby rotates with the shaft 26, and there is no relative motion between the gears 140, 152. When the gear housing 146 reaches a release slot 154 in the housing 14, the spring biased plunger 144 slides into the release slot 154, thereby releasing the shaft 26, the ring gear 150 is fixed relative to the housing 14 and the drive gear 152 rotates with the shaft 26, thereby driving the flexible transection blade 112 forward.

[00201] With particular reference to Figure 29, in still another embodiment a lead screw 156 is used to enable the shaft 26 to advance and rotate, stop advancing but continue rotating and then retract to its original position. The shaft 24 includes an opening 158 leading to a shaft threaded section 160. The lead screw 156 is rotatably fixed to the housing 14 and includes a first end portion 162, a second end portion 164, and a lead screw threaded section 166, which meshes with the shaft threaded section 160.

[00202] The shaft 26 is driven forward (to the right in Figure 29) until the back edge of shaft 174 reaches the front edge of lead screw threads 178. At this position, the shaft 26 will continue to rotate but no longer advances. The shaft threaded portion 160 is supported by shoulder 180. A first spring 168 makes contact with surface 172 exerting a slight backward force on the shaft 26.

[00203] When the drive assembly 40 is reversed, the force exerted on surface 172 by the first spring 168 urges re-start of threads between the shaft 26 and the lead screw 156. The shaft 26 will then move backward until the contact surface 176 clears the surface 172. A second spring 170 now provides force to urge restart in the forward direction.

[00204] This configuration may also be adopted to drive the flexible transection blade 112.

[00205] With particular reference to Figure 30 in still another embodiment, a drive screw 184 may be used to drive motion of the flexible transection blade 112. A drive gear 182 is fixed to the drive screw 184 which is threadably coupled to the drive dog 186. During forward motion of the coring cannula 20, the drive dog 186 is allowed to slip relative to the drive screw 184. During activation of the flexible transection blade 112, the drive gear 182, and thus, the drive screw 184 rotate. The drive dog 186 has an internal threaded bore (not shown) which is mated with the drive screw 184. As the drive screw 184 rotates, the drive dog 186 advances (or retracts) along the screw 184, thereby advancing the flexible transection blade 112.

[00206] With particular reference to Figure 31, in a further embodiment, a modification is shown. In the illustrated embodiment, the drive dog 186' is fixed to an end of the drive screw 184'. The drive gear 182' has in internal threaded bore (not shown) which is mated with the drive screw 184'. As the drive gear 182' rotates, the drive screw 184' and the drive dog 186' advances or retracts.

[00207] As discussed more fully below, the cutting edge 114 of the cutting cannula 20 may be formed by a cannula insert 188 and may have different configurations.

[00208] With particular reference to Figures 32A and 32B, the cannula insert 188 forms a circular coring blade 190. As shown the flexible transection blade 112 advances past the circular coring blade 190. The flexible blade 112 transects tissue distal to the front edge of cutting ring 190.

[00209] With particular reference to Figures 33A and 33B, in another embodiment the cannula insert 188 forms a partial cutting ring 192. The partial cutting ring 192 forms a partial cutting face 194 with an angled edge 196. As the coring cannula 20 rotates, the angled edge 196 cuts through the tissue. As shown, with the partial cutting ring 192, the flexible transection blade 112 does not extend past the furthermost edge of the partial cutting rung 192. Thus, the tissue sample is confined within the cutting ring 192.

[00210] With particular reference to Figures 34 A and 34B, in still another embodiment, the cutting edge 114 of the flexible transection blade 112 is used to core the sample tissue (Figure 34 A). The flexible transection blade 112 is then advanced to transect tissue (Figure 34B).

[00211] With particular reference to Figure 35, a prior art cutting ring 200 is shown. The prior art cutting ring 200 is nestled within a bore 202 of the distal end of the cutting cannula 20. As shown, the coring cannula 20 has an inner diameter of dl and the cutting ring 200 has an inner diameter of d2. In the prior art device shown in Figure 35, dl is substantially equally to d2. The outer surface of the coring cannula 205 has a ramping surface 206 from the outer dimension of the coring cannula 205 to the distal end of the coring cannula 205. As shown, the outer diameter of the coring cannula d4 is greater than the outer dimension, d3, of the prior art cutting ring 200. [00212] In the prior art cutting ring 200 of Figure 35, the mechanism for transecting the tissue sample is a garrote wire 204 which transverses the outer wall of the coring cannula 20. At a location near the distal end of the coring cannula 205 the garrote wire 204 forms a right angle and encircles the inner diameter of the coring cannula 20. As shown, this occurs at a substantial distance, d5, from the distal end of the cutting ring 200. This arrangement presents two problems. First, the 90 degree bend in the garrote wire 204 significantly increases the force required to pull the garrote wire and transect the tissue. Second, the large distance, d5, between the garrote wire 204 and the cutting edge of the cutting ring 200, results in a core of tissue, or tissue plug, which is cored by the coring cannula 205, but not transected by the garrote wire. This cored tissue thus remains in the breast.

[00213] With particular reference to Figures 36A and 36B, in one embodiment a partial cutting ring 208 may be provided. The illustrated partial cutting ring 208 may include a face cutting surface 208A, which has a cutting edge perpendicular to the axis 24, and a side cutting surface 208B. The use of the side cutting surface 208B introduces side cutting. Side cutting is less likely to result in unwanted pushing or movement of tissue. Additionally, the blade angle allows the garrote wire 210 to be installed outside of the coring blade and then clear of the cutting ring when retracting. This also limits the tissue plug problem identified above. Furthermore, the angle in the garrote wire 210 may be increased (as shown), reducing the required transection forces (see Figures 406A, 406B, 406C).

[00214] With reference to Figures 38A, 38B, and 39 in an other aspect of the present invention, the coring cannula 20 may include an external cutting ring 198. The external cutting ring 198 has an interior bore 212 within an interior diameter, d2. The coring cannula 20 has a reduced diameter portion 214 at its distal end. As shown, the external cutting ring 198 is fitted over the reduced diameter portion of the coring cannula 214. As shown, the outer diameter (d4) of the coring cannula 20 is substantially equal to the outer diameter of the external cutting ring, d3.

[00215] As shown, the transecting mechanism 122 may include a garrote wire 210.

[00216] With specific reference to Figures 38A and 38B, in one embodiment the garrote wire 210 is removably coupled to the coring cannula 20 by one or more bent tabs 216 formed integrally with the coring cannula 20. The one or more bent tabs 216 may be integrally formed with the coring cannula 20. The mechanism 122 is located at the distal end of the coring cannula 20. The distal end of the coring cannula 20 is within a minimal distance of the distal end of the external cutting ring 198. This minimizes the tissue plug problem discussed above. In one embodiment, the minimal distance is < 0.25 inches.

[00217] With specific reference to Figure 39, the distal end of the external cutting ring 198 is spaced from the distal end of the coring cannula 20. In the illustrated embodiment, the mechanism 122 is located at the distal end of the external cutting ring 198. The mechanism 122 is within the minimal distance of the distal end of the external cutting ring 198. The garrote wire may be removably held in place by one or more tabs 218 which may be formed integrally with the cutting ring 198.

[00218] With particular reference to Figure 41, in one aspect of the present invention, the coring cannula 20 may be provided with a cutting ring in which the inner diameter of the coring cannula 20 has an inner diameter which is smaller than the inner diameter of the cutting ring. Tissue is flexible, malleable and compressible. With the inner diameter of the coring cannula 20 being smaller than the inner diameter of the cutting ring, the tissue sample is compressed as it enters the coring cannula 20 (behind the cutting ring). Compression of the tissue sample results in better retention of the tissue sample in the cannula 20. Additionally, with the reduced inner diameter of the cannula 20, the outer diameter of the cannula 20 may also be reduced, until it is the equal to or nearly equal to the outer diameter of the cutting ring. This results in (1) a smaller entry incision and (2) reduction of the required coring cutting force.

[00219] With particular reference to Figure 40, a prior art cannula 222 is shown. The prior art cannula 222 has a cutting ring 224. The prior art coring cannula 222 has an inner diameter (dl) which is equal to the inner diameter (d2) of the cutting ring 224. Additionally, the outer diameter (d4) of the prior art coring cannula 222 is greater than the outer diameter (d3) of the cutting ring 224.

[00220] With particular reference to Figure 41, a coring cannula 226 according to an embodiment of the present invention is shown. The coring cannula 226 has a distal end 228 and is centered on the axis 24 and is coupled to the housing 14. The coring cannula 226 having an inner surface 230 forming a cannula bore 232. The cannula bore 232 has an inner diameter (dl) and is rotatable about the axis. A cutting ring 234 has an inner surface 236 which forms a cutting ring bore 238 and is located at the distal end of the coring cannula 226. The cutting ring bore 238 has an interior diameter (d2). A tapered wall 240 is coupled between the coring cannula 226 and the cutting ring 234. The tapered wall 240 provides a ramped surface between the inner surface 236 of the cutting ring 234 and the inner surface 236 of the coring cannula 226.

[00221] As discussed, the inner diameter, dl, of the cannula bore 232 is less than the inner diameter, d2, of the cutting ring 234. Furthermore, the outer diameter, d4, of the coring cannula 226 is equal to, or only slightly larger than, the outer diameter, d3, of the cutting ring 234.

[00222] In one embodiment, the coring cannula 226 and the cutting ring 234 are unitarily formed. In an other embodiment, the coring cannula 226 and the cutting ring 234 are formed separately. In one embodiment (as described above), the coring cannula 226 may have a reduced diameter portion formed at the distal end 228. The cutting ring 234 is an external cutting ring which is fitted over the reduced diameter portion of the coring cannula. The distal end of the cutting ring 234 forms a coring cannula cutting edge 238.

[00223] With reference to Figures 42A, 42B, 43A, 43B, 43C, in another aspect of the present invention a collapsible stylet may be provided (see below). With particular reference to Figures 42A and 42B, a prior art stylet 242 is shown. The prior art stylet 242 is contained within the coring cannula 244. The prior art stylet 242 has a slot 243 for the stylet blades 246. The diameter, dl, of the prior art stylet 242 is fixed, and smaller than the diameter, d2, of the cutting edge 248 of the coring cannula 244. Thus, in use, after the stylet 242 has cut into the tissue, the skin may need to be opened further to allow the coring cannula 244 to enter the tissue.

[00224] With particular reference to Figures 43A, 43B, and 43C, a collapsible stylet 250 according to one embodiment of the present invention is illustrated. The coring cannula 20 has a distal end 252, a longitudinal axis 24 and is centered on the axis 24 (see above). The collapsible stylet 250 has a tip 254, which contains at least one blade 256, and a central passage 258 and is coupled to the coring cannula 20. The tip 254 has a recess 260 located near a proximal end 262 thereof. The tip 254 is movable between an initial configuration (shown in Figures 43A and 43B) and a contracted configuration (shown in Figures 43C and 43D). When the tip 254 is in the initial configuration, the cutting edge 264 of the coring cannula 20 is within the recess 260. This allows the coring cannula 20 to enter the incision with the stylet 250, prior to the coring process, without the need to widen or open the incision any further. The tip 250 remains in the initial configuration as the coring cannula 20 is moved from the initial cannula location towards the final cannula location. Once the coring cannula 20 reaches the final cannula location, the tip may be moved into the contracted configuration (Figure 43C). In the contract configuration, the cutting edge 264 of the coring cannula 20 is exposed when the tip 254 is in the contracted configuration.

[00225] In the illustrated embodiment, the tip 254 has a first half portion 254A and a second half portion 254B. As shown in the illustrated embodiment, the first and second half portions 254A, 254B have a semi-circular cross-section (see Figures 43B and 43C) and an inner surface 268A, 268B. The inner surface 266A of the first portion 254A faces the inner surface 266B of the second portion 254B. The first and second half portions 254A, 254B have a first part 268A, 268B and a second part 270A, 270B. The second parts 270A, 270B are sloped and curved forming an entry segment 272. The first and second parts 268A, 268B form a linear segment 274. The linear segment 274 has an associated first diameter, (dl), when the tip is in the initial configuration (Figure 43B). The first diameter associated with the linear segment 274 is greater than or equal to a diameter associated with the cutting edge 248 of the coring cannula 20. Thus, the cutting edge 248 can sit within the recess 260 prior to the coring process (see above).

[00226] As shown in Figure 43C, when the tip 254 is in the contracted configuration the linear segment 274 has a second diameter, (d2). The second diameter is less than diameter associated with the cutting edge 248 of the coring cannula 20. This allows the coring cannula 20 to be rotated and moved forward (over the stylet) to perform the coring process.

[00227] In one embodiment, the first and second half portions 254A, 254B are biased towards the initial configuration. In the illustrated embodiment, the collapsible stylet 250 includes a collet tube 251 and a collet closer 253. As shown, the tube 251 includes a ramping portion 251 A and a distal end 25 IB. The distal end 25 IB is fitted between the first and second half portions 254A, 254B and bias the first and second half portions 254A, 254B into the initial configuration. A collet closer 253 is provided which is movable between a first position (shown in Figure 43A) and a second position (shown in Figure 43C). The collet closer 253 acts on the ramping portion 251A of the collet tube 251 to compress the distal end 25 IB. This allows the first and second half portions 254A, 254B of the collapsible stylet 250 to collapse to the contract position. The collet closer 253 may be movable from the first position to the second position by the user through actuation of a button provided on the housing 14 (not shown). [00228] With specific reference to Figures 44 and 45, in another aspect of the present invention, an independent stylet mechanism 276 is provided. With particular reference to Figure 44, a prior art stylet 278 is shown. The prior art stylet 278 includes integral cutting blades 280. Since the integral cutting blades 280 are fixed relating to the stylet tip, the distance between the blades 280 and the stylet 278 is fixed at a minimal distance. This increases the chances of inadvertent movement or compression of the tissue, i.e., "snowplowing".

[00229] With specific reference to Figure 45, the independent/retractable stylet mechanism 276 includes a tube 282 and at least one stylet blade 284 affixed to the tube 282. A stylet 286 includes a stylet tip 288 with a central passage 290. The tube 282 is slidably disposed within the central passage 290 of the stylet 286.

[00230] In the illustrated embodiment, the stylet mechanism 276 includes first and second blades 284 A, 284B.

[00231] In one aspect, the tube 282 may include an internal bore 292 for receiving the guide element 52 (see above).

[00232] The independent retractable stylet mechanism 276 is adjustable within along the central passage 290 of the stylet 286. Thus, the user can adjust the distance between the blades 284 and the stylet tip 288 to reduce the chance of snowplowing occurring.

[00233] With reference to Figures 46A-46D and 47A-47C, in another aspect of the present invention, a localization needle with an integral locking member 294 is provided. In one embodiment, the localization needle 294 includes a needle portion 296 and a locking member 304. The needle portion 296 having a proximal end 298, a distal end 300 and a channel 302 formed therein.

[00234] The locking member 304 is formed integrally with the needle portion 296. As shown, the locking member 304 may be formed at the distal end 300 of the needle portion 296 and has an unlocking configuration (shown in Figure 46A) and a locking configuration (shown in Figure 46B).

[00235] In the illustrated embodiment, in the unlocking configuration, the localization needle 294 is straight, i.e., without bends or kinks. In the locking configuration, bends, or barbs, as shown in Figure 46B have been introduced into the localization needle 294. These bends, barbs, are introduced into the localization needle 294 after the localization needle 294 has been inserted into the breast, thereby locking the localization needle 294 relative to the target tissue (see above).

[00236] In one embodiment, the localization needle 294 includes an actuation device 306. The actuation device 306 is coupled to the distal end 300 and is used to apply a force thereto (see Figure 46B). The force acts to bring the distal end 300 closer to the proximal end 298. With the proximal end 298 fixed to, for example, the housing 14 of the biopsy device 10, the localization needle 294 collapses at the locking member 304 creating the barbs, or extensions, as shown, thereby controllably moving the locking member from the unlocking configuration to the locking configuration.

[00237] In one aspect of the present invention, the actuation device 306 includes a member 308 coupled to an inner surface of the distal end 300 of the needle portion 296.

[00238] With particular reference to Figure 46C, in one embodiment the member 308 may include a wire 310 fixed to the inner diameter of the localization needle 294. The wire 310 may be attached to a lever (not shown) on the housing, or some other suitable mechanism, which pulls the wire 310 back toward the proximal end 298.

[00239] In another embodiment, the member 308 is a threaded rod 312 which is received by a threaded receiving member 314 which is coupled to the inner surface of the distal end 300 of the needle portion 296. This arrangement allows the localization needle 294 to be moved back into the unlocking configuration if the placement needs to be corrected.

[00240] In another aspect of the present invention, the locking member 304 is formed by at least one pair of opposed slots 316 within the needle portion 296. In one embodiment, the slots 316 may be laser cut from the needle portion 296. As shown in Figures 46A-46D, in one embodiment, the slots 316 may have a general rectangular shape with rounded ends. The slots 316 may include one or may directional cutouts 317 which assist in forming the extensions or barbs. The directional cutouts 317 may be triangular shaped.

[00241] In another aspect of the present invention the slots 316 may have a general diamond shape, as shown in Figures 47A-47C.

[00242] With particular reference to Figures 48 A, 48B, and 49, in another aspect of the present invention, one or more rotating circular blades 318, 318A, 318B may be used. The use of the rotating circular blades 318, 318A, 318B improves the efficiency of the stylet and reduces the risk of compression and/or tearing of the tissue as the stylet in pushed into the breast. [00243] The rotating circular blade(s) 318, 318A, 318B may be powered (see below) or may rotating freely. The rotation of the blade (s) 318, 318A, 318B whether from an external source or as a result of friction between the blade 318, 318A, 318B and the tissue, creates relative motion therebetween.

[00244] With particular reference to Figure 48A, in one embodiment a stylet 320 is provided with a single rotating circular blade 318. The stylet 320 is coupled to a coring cannula 322. The coring cannula 322 has a longitudinal axis 324 and is centered on the axis 324. The stylet 320 is coupled to the coring cannula 322. The stylet 320 includes a stylet tube 326. The rotating circular blade 318 is rotatably coupled to a distal end 328 of the stylet tube 326.

[00245] With particular reference to Figure 48B, in another embodiment, the rotating circular blade 318 is not mechanically driven, but is allowed to freely rotate. As the device 10 is advanced into the tissue, force exerted by the tissue will tend to rotate the circular blade 318, eliminating the tendency to push/tear tissue and improving cutting efficiency.

[00246] In both embodiments, the singular rotating circular blade 318 is mounted on its center point 334. As shown, the center point 334 is centered over the stylet tube 326.

[00247] The rotating circular blade 318 defines a first plane which is parallel to the axis 324. The axis defines a second plane. The first and second planes intersect at a right angle. The center point 334 of the rotating circular blade 318 is located on both the first and second planes.

[00248] A blade drive mechanism 330 is coupled to the rotating circular blade 318 for controllably rotating the circular blade 318. In one embodiment, the blade drive mechanism 330 may include a motor (not shown) and drive cable 332. Alternatively, the blade drive mechanism 330 may include a rod and gearing system (not shown).

[00249] With particular reference to Figure 49, the stylet 320 may include a pair of offset blades 318A, 318B. The second blade 318B defines a third plane which is parallel to the first plane. As shown in Figure 39, the center 334 A, 334B of the blades 318A, 318B are offset a predetermined distance. The first and second blades 318A, 318B may be mechanically driven or may be allowed to rotate freely.

[00250] Returning to Figures, 2A-2D, 5A and 5B, in another aspect of the present invention the biopsy device 10 includes at least one retractable stylet blade 336. The at least one retractable stylet blade 336 is part of a stylet blade mechanism 338. The stylet blade mechanism 338 may include first and second retractable blades 336A, 336B, as shown.

[00251] The stylet blade mechanism 338 is coupled to the coring cannula 20 via the stylet tip 30. In one embodiment, the stylet blade mechanism 338 includes the stylet tube 36. The at least one retractable stylet blade 336 is fixed to the stylet tube 36. The stylet tube 36 is slidably disposed within the stylet housing 38. The central passage 34 is formed by the stylet tube 36.

[00252] The stylet blade mechanism 338 is movable between a cutting position and a retracted position. In the cutting position, the at least one stylet blade is located a distance in front of the stylet tip 30 (as shown). In the retracted position, the at least one stylet blade 336 is located within the stylet tip 30.

[00253] In one embodiment, the stylet blade mechanism 338 may be manually moved from the retracted position to the cutting position. In one embodiment, the stylet blade mechanism 338 is spring biased towards the cutting position.

[00254] As discussed above, the biopsy device 10 may further comprise a guide portion 108 formed at the end of the stylet tube 30. The guide portion 108 extends past an opening of the stylet tube 30. The guide portion 108 having an interior curved surface 340. The interior curved surface 340 assists in guiding the end of the guide element 52 into the central passageway 108.

[00255] It should be noted that the stylet blade mechanism 338 and the retractable stylet blades 336 may be used with either integrated localization needle or the independent needle (see above). With respect to Figures 5 A and 5B, the stylet blade mechanism 338 is used with the independent needle handle assembly 18'. As discussed above, the independent needle handle assembly 18' is inserted into the breast, the guide element 52 is extended outside of the needle 54 and the locking member 62 is affixed to the target tissue. Once the locking member 62 is locked into the target tissue, the guide element 52 is removed from the needle 54. The guide element 52 is then inserted into central passageway 108.

[00256] With the guide element 52 within the central passageway 108 and the stylet blade mechanism 338 in the cutting position, the biopsy device 10 is slid up the guide element 52, the stylet blades 336 cutting the tissue and allowing the device 10 to reach the target tissue. Once the target tissue is reached, the stylet blade mechanism 338 can be retracted such that the blade(s) 336 are contained within the tip 30. The coring cannula 20 can then be advanced over the target tissue.

[00257] With reference to Figures 50A, SOB, 50C, SOD, 51 A and 5 IB, in still another aspect of the present invention, a garrote wire 210 is used to transect the tissue sample.

[00258] The prior art devices, which employ a garrote wire, use a linear pull "trigger" system to activate the garrote wire. A limitation of the design is the travel required to fully pull the garrote wire. This limitation becomes an issue for larger cannula sizes. As the cannula diameter increases, the length of garrote wire required to transect tissue increases resulting in an increase in required travel. The travel length is limited by the overall length of the device. Continuing to increase the device length is not a viable option.

[00259] As discussed below, the breast biopsy device 10 may include a trigger mechanism 342 which includes a trigger 344 (shown diagrammatically in Figures 50A-51B). The trigger 344 is generally pulled backward to pull garrote wire 210 backward, thereby transecting the tissue sample within the coring cannula 20.

[00260] As shown in Figure 50 A, the breast biopsy device 10 includes a pair of rotatable cleats 346 which are coupled to the housing 14 (through a trigger body 350) and are rotatable between a first cleat position (shown in Figure 50A) and a second cleat position (shown in Figure SOB). As shown, in one embodiment, the rotatable cleats 346 include a plurality of teeth 348 which grip the garrote wire 210. The cleats 346 are coupled to the trigger mechanism 342 and when the trigger mechanism 342 is actuated, i.e., pulled backward relative to the housing 14. Friction causes the cleats 346 to rotate, thereby engaging the teeth 348 into the garrote wire 210. Then, as the trigger mechanism 342 is pulled backward, the cleats 346 move therewith, pulling the garrote wire 210 as well.

[00261] With specific reference to Figure 50A, when the garrote wire 210 is in a first position, the wire 210 forms a loop 352 which is external to the coring cannula 20. After the coring cannula 20 is extended and surrounds the sample tissue, the trigger mechanism 342 is used to complete separate the sample tissue from the breast.

[00262] In one embodiment, a single actuation of the trigger mechanism 342, e.g., a single pull of the trigger 342, moves the garrote wire 210 from the first wire position to a second wire position in which the garrote wire 210 is within the coring cannula 20 (and the sample completely separated from the breast). [00263] In another embodiment, multiple actuations of the trigger mechanism 342, or multiple pulls of the trigger 344, are required. In the illustrated embodiment, two pulls of the trigger 344 are required. Each pull of the trigger 344, moving the garrote wire a distance defined by the distance between XI and X2.

[00264] Figure 50A shows the garrote wire 210 in an initial position with the loop 352 in its largest configuration. Figure SOB shows the garrote wire 210 in an intermediate location, after the first pull of the trigger 344 (the trigger 344 and trigger body 350 are shown at full travel).

[00265] Figure 50C shows the garrote wire 210 at the intermediate location, with the trigger body 350 returned to the initial position. In one aspect, the trigger body 350 is spring biased back to the initial position. In another aspect, the trigger body 350 may be manually moved back to the initial position.

[00266] Figure 50D shows the garrote wire 210 at the final location, fully actuated and within the coring cannula 20. At this point, the sample is completely severed from the breast.

[00267] This improvement to the linear pull system will enable the use of larger cannula sizes to provide for multiple pulls of the trigger 344 on the garrote wire 210. Multiple pulls can be accomplished using the breakaway cleat system. The cleat system works as follows: When the trigger 348 is pulled, cleats 346 with separated edges or teeth 348 grip the garrote wire 210, allow the trigger 344 to pull the wire 219 the full length of travel. At the end of travel, the trigger 344 is pushed forward back to the start position. When the trigger 344 is moved in this direction, the cleat 346 (cam) disengages the wire so that the trigger 344 slides forward without affecting the wire 210. As the trigger 344 is pulled back, the cleats 346 re-engage the wire 210, pulling it to further transect tissue. This process is repeated until transection is completed.

[00268] With reference to Figure 51 A in a further embodiment, a second pair rotatable cleats 354 may be fixed directly to the device 10, e.g., directly to the housing 14. The second pair of rotatable cleats 354 are not fixed to the trigger body 350. The second pair of cleats 354 prevented undesirable forward motion of the garrote wire 210.

[00269] With reference to Figure 5 IB in an other embodiment, the garrote wire 210 may have a number of beads 356 fixed thereto (crimped or welded thereon) to assist in grabbing of the wire by the cleats 346, 354. [00270] As discussed above, the prior art utilizes a linear pull trigger system, in which the trigger is pulled straight back to actuate the garrote wire. The trigger rides in a track and is supported by guide rods to maintain the desired linear pull. When the trigger is pulled back it engages a support ring attached to the garrote wire. This support ring moves backward with the trigger, pulling the garrote wire across the cannula, transecting the core of tissue at the distal end. However, there are a significant number of cases which encounter "tough" breast tissue. When tough tissue is encountered, transection force increases significantly, at times resulting in incomplete transection. The user cannot provide enough input force to fully actuate the trigger system. Occurrences of this problem increases as cannula diameter increases.

[00271] Constriction and transection of breast tissue by the garrote wire can best be described by separating it into two phases. Phase 1 includes 0% to 70-95% constriction of the tissue by the garrote wire. The 70-95% range is dependent on cannula size and tissue density. The requirements of Phase 1 are long travel and low/medium input force. The current linear pull system works well during Phase 1. Phase 2 covers up to the final 30% of tissue constriction and eventual transection. The requirements of Phase 2 are limited travel with potentially high input forces required. The linear pull system does not always meet these requirements.

[00272] With reference to Figures 52A, 52B, 52C, and 52D, in another aspect of the present invention, the garrote wire 210 actuation by a trigger mechanism 358. The trigger mechanism 358 is coupled to the housing 14 and the garrote wire 210 (via support ring 4060). In the illustrated embodiment, the trigger mechanism 358 includes a trigger 360 slidably mounted in a trigger channel 362 in the housing 14. In the illustrated embodiment the trigger channel 362 is formed by a linear support track 368 within the housing 14. The trigger 360 is movable from a first trigger position (shown in Figure 52A and 52B) to an intermediate trigger position (shown in Figure 52C) within the trigger channel 362.

[00273] The garrote wire 210 is coupled directly to the trigger 360. In response to the trigger 360 being moved from the first trigger position to the intermediate trigger position, the garrote wire is moved from the first wire position to an intermediate wire position. In the illustrated embodiment, the triggers 360 drops into a cam channel 366 once it reaches the intermediate trigger position. [00274] Once the trigger 360 reaches the intermediate trigger position it can move no further within the trigger channel 362. The trigger 360 is further rotatably movable about a trigger axis 364 from the intermediate trigger position to a second trigger position (shown dotted lines in Figures 52D). In response to movement of the trigger 360 to the second trigger position, the garrote wire 210 is moved from the intermediate wire position to the second wire position in response thereto.

[00275] The addition of a rotational cam mechanism, i.e., the rotatable trigger 360, to the trigger mechanism 358 will address Phase 2. The rotational cam provides a mechanical advantage to the user allowing greater input force with limited travel. The concept described here is a ^c¾ybrid" system, using the linear pull system for the first 70-95% wire travel and then switching to the rotational cam system for the final phase of transection.

[00276] In use, the user will pull the trigger 360 along the linear track. At an optimized position, the trigger 360 will reach the end of the trigger channel and engage the cam activation system In this position the trigger will no longer translate, but will now rotate so that the input force is transferred through the cam to the support ring 4060.

[00277] A stabilization assembly may be used in conjunction with a tissue excision device to allow a surgeon to maintain control of a tissue anchor and prevent movement of the tissue anchor during introduction of an excision device into breast tissue.

[00278] Referring now to FIG. 53, an isometric view of an exemplary guide rod assembly according to one embodiment of the present invention is shown. Guide rod 104 includes a hook 400 that extends from the proximal end of the guide rod 104.

[00279] Referring now to FIG. 54, a side view of an exemplary excision device 10 with an anchor stabilization rod 402 is shown. Due to the soft nature of some breast tissue, it is virtually impossible to securely an anchor it into position, regardless of the anchor design. Anchor stabilization rod 402 extends through and slides freely within the central passageway

404 of the excision device 10.

[00280] In one aspect of the present invention, the excision device 10 includes a coupling device 406 that may be used to controllably couple and decouple the anchor stabilization rod 402 with the guide rod 104.

[00281] Referring now to FIG. 55, a partial isometric view of an anchor stabilization rod 402 and a guide rod 104 including a hook-and-loop coupling device 406 is shown. In one embodiment of the present invention, the distal end of the anchor stabilization rod 402 includes a loop 408. The loop 408 is designed to engage with the hook 400 on the proximal end of the guide rod 104. The hook-and-loop configuration provides an easy method for the surgeon to initially engage and secure the guide rod 104.

[00282] Referring now to FIG. 56, a partial isometric view of an anchor stabilization rod 402 and a guide rod 104 including a coupling device 406 according to a second embodiment of the present invention is shown. In the second embodiment, the distal end of the anchor stabilization rod 402 and the proximal end of the guide rod 104 have notches 410 that engage with one another to connect the two rods 104, 402 to one another.

[00283] Referring now to FIG. 57, a partial isometric view of an anchor stabilization rod 402 including a coupling device 406 according to a third embodiment of the present invention is shown. In the third embodiment, the distal end of the anchor stabilization rod 402 includes a wireform attachment 412. The wireform attachment 412 includes convex curves 386. The proximal end of guide rod 104 is hollow and includes a plurality of apertures 388 and an opening 390. The wireform attachment 412 is inserted into the opening 390. The wireform attachment 412 compresses as it is inserted into guide rod 104. When the convex curves 386 reach the plurality of apertures 388, the wireform attachment 412 expands slightly such that the convex curves 386 engage with the apertures 388, forming a cross-hold with the guide rod 104 and connecting the two rods 104, 402 to one another.

[00284] Referring again to FIG. 54, once the rods have been connected by the coupling device 406, the surgeon (or an assistant) maintains control over the position of the tissue anchor by holding onto a knob 392 at the proximal end of the anchor stabilization rod 402. As the surgeon advances the device 10 forward, the joint (not shown) where the coupling device 406 connects the two rods 104, 402 is contained within the central passageway 404 of the excision device 10. Once the joint is contained, the only motion allowed of the rods 104, 402 will be forward or backward along the axis of the central passage 404. In addition, the size of the tube that creates the central passageway 404 in the excision device 10 is designed to compress the coupling device 406, so that the two rods 104, 402 cannot become disengaged when inside the central passageway 404.

[00285] Referring now to FIG. 58, an isometric view of an exemplar}' excision device with an anchor stabilization rod and fixed support arm is shown. In addition to the control provided to the surgeon or an assistant by the knob 392, a fixed support arm 394 may be attached to the proximal end of the anchor stabilization rod 402 for additional support. After the two rods 104, 402 have been connected and entered into the central passageway 404 of the excision device 10, the proximal end of the anchor stabilization rod 402 may be attached to the fixed support arm 396, which would hold the rods 104, 402 securely in position. The fixed support arm 394 may be flexible in its unattached state to enable it to be attached easily to the anchor stabilization rod 402. After the fixed support arm 394 is attached to the anchor stabilization rod 402, the anchor stabilization rod 402 is locked in position. The fixed support arm 394 may attach to the side of a surgical bed, a floor stand, or any other stationary object or surface.

[00286] In one embodiment of the present invention, an expanding cannula 400 provides a means to enable the surgeon to excise a larger tissue sample and remove it from the breast through a smaller skin incision. By way of example and not limitation, the exemplary expanding cannula described herein allows for the excision of a IS mm diameter tissue sample through a 10 mm skin incision.

[00287] Referring now to FIG. 59, a partial isometric view of an expanding cannula 400 according to an embodiment of the present invention is shown. In a preferred embodiment, expanding cannula 400 is approximately 8 mm in diameter is designed to enter the breast through a 10 mm skin incision. The expanding cannula 400 is introduced into the breast using a bladed stylet with a flexible transaction blade (not shown in FIG. 59). The initial configuration of the expanding cannula 400 with blade may be similar to the configuration shown in FIG. 34A. The flexible transection blade 112 is exposed as the expanding cannula 400 of FIG. 59 is inserted into the breast.

[00288] When the expanding cannula 400 reaches the target area, the stylet is retracted, exposing the distal end 402 of the expanding cannula 400. After the stylet has been retracted, the expanding cannula 400 is rotated. The expanding cannula 400 may rotate in a manner similar to the coring cannula 20 of FIG. 20 A, when the flexible transection blade 112 is in the first blade position it is contained within the coring cannula 20, and thus, not visible. However, the expanding cannula 400 of FIG. 53 rotates but does not advance, whereas the coring cannula 20 of FIG. 20A both rotates and advances.

[00289] In one embodiment, after the stylet has been retracted, the expanding cannula 400 may alternatively be rotated using a motor drive, such as the exemplary motor drive described in FIG. 24. [00290] Referring now to FIG. 60, a partial isometric view of a partially expanded expanding cannula 400 is shown. As the expanding cannula 400 rotates, an expanding coring mechanism 404 begins to advance out of the distal end 402 of the expanding cannula 400. The expanding coring mechanism 404 includes a flexible blade 406. The flexible blade 406 is in the retracted position, with only an exposed edge exposed. The exposed edge of the flexible blade 406 begins to core a cylinder of tissue as it advances forward through the tissue. The expanding coring mechanism 404 is configured such that the diameter of the shape formed by the exposed edge of the flexible blade 406 increases as the expanding coring mechanism 404 advances.

[00291] In the illustrated embodiment, a ring 408 at the distal end of the expanding coring mechanism 404 is formed by an annular spring 410 initially in the compressed position. As the annular spring 410 advances axially, it begins to expand.

[00292] Referring now to FIG. 61, a partial isometric view of a fully expanded expanding cannula is shown. The rate and amount of expansion of the annular spring 410 is controlled by a plurality of formed fingers 412 that define the shape of the cavity. During the initial phase of advancement, the size of the annular spring 410 advances to its full diameter. After the full diameter of the annular spring 410 has been reached, the formed fingers 412 continue to advance axially to a pre-determined distance that has been established to define the length of the excised tissue specimen (not shown). When the formed fingers 412 are fully extended, the flexible blade 406 begins to advance, transecting the distal end of the tissue specimen. The advancement of the flexible blade 406 may be similar to the advancement of flexible transection blade 112 as shown in FIGS. 21 A and 22A.

[00293] After completion of the procedure, the excision device with the tissue specimen contained is removed from the breast.

[00294] In one embodiment of the present invention, an incision expander 414 provides a means to enable the surgeon to introduce an excision device 10 with a larger diameter through a smaller skin incision than would otherwise be possible. By way of example and not limitation, the exemplary incision expander described herein allows for the excision of a IS mm diameter tissue sample through a 10 mm skin incision.

[00295] Referring now to FIG. 62, an isometric view of an assembled incision expander 400 according to a first embodiment is shown. Incision expander 414 includes a housing 416, an expanding cannula 418, a mechanism to expand the cannula, such as levers 420, and a removable bladed stylet 422. In general, the housing 416 is cylindrical and the diameter may be increased. The removable bladed stylet 422 is housed within the housing 416 when the housing 416 has a reduced diameter. The bladed stylet 422 (within the housing) is inserted into the breast to create an incision. The bladed stylet 422 is removed and the diameter of the housing 416 is increased to allow for introduction of a large excision device through the incision, as described below.

[00296] In one embodiment, the incision expander 414 is initially introduced into the breast through an incision that is approximately 10mm long. After the initial 10mm incision is made by the surgeon, the incision expander 414 is pushed into the breast. The flat blades on the front edge of the bladed stylet 422 cut and separate the tissue.

[00297] Referring now to FIG. 63, an isometric view of a disassembled incision expander 414 is shown. After the incision expander 414 has been fully inserted into the breast, one or more levers 420 are actuated to increase the diameter of the expanding cannula 418.

[00298] The expanding cannula 418 may be comprised of a thin sheet of material that is formed into a c linder. The expanding cannula 418 may be comprised of a metal, a polymer, or any material that has the ability to maintain its cylindrical form as it expands and contracts. The wall of the expanding cannula 418 overlaps itself, which allows it to maintain its cylindrical configuration as it expands. The one or more levers 420 are connected to the housing 416 and the expanding cannula 418. Actuating the one or more levers 420 expands the diameter of the housing 416 and the expanding cannula 414. After the cylinder has been expanded, the bladed stylet 422 can be removed from the incision expander 414.

[00299] Referring now to FIG. 64, an isometric view of an incision expander 414 with bladed stylet 422 removed and expanded cannula 418 in an expanded state is shown. The incision expander 414 then remains in the breast in its expanded position after the bladed stylet 422 is removed (not shown). In this configuration, the opening through the center of the incision expander 414 (via the housing 416 and the expanding cannula 418) is large enough to allow the introduction of a larger excision device, such as the exemplary excision device described herein.

[00300] After the procedure has been completed (i.e., the tissue sample has been excised using the excision device 10), and the excision device is removed from the breast tissue, the one or more levers 420 are moved back to their initial position (as shown in FIG. 62), which reduces the diameter of the cylinder of the expanding cannula 418 and the diameter of the housing 416. The incision expander 414 is then removed from the breast.

[00301] Referring now to FIG. 65, an isometric view of an assembled incision expander 424 according to a second embodiment is shown. The incision expander 424 includes a long, tapered, bladed stylet 426. The tapered section of the stylet 426 gradually expands the diameter of the incision as it is introduced into the breast. When the incision expander 424 is fully introduced, the stylet 426 is removed, leaving the larger diameter expanding cannula 418 in place in the breast. In one embodiment, cannula 418 is an expanding cannula The incision is partially expanded by the tapered end of stylet 424 and then further expanded by expanding cannula 418, as described above. In an alternate embodiment, cannula 418 is not an expanding cannula and the expansion of the incision is performed solely by the tapered end of stylet 424.

[00302] A compression device described below compresses and supports the breast during a breast biopsy procedure. Although designed for use in conjunction with the exemplary excision devices described herein, the compression device can be used with any excisional or incisional biopsy device.

[00303] Referring now to FIG. 66, an isometric view of a breast compression device 430 according to a first embodiment is shown. Breast compression device 430 includes a back plate 432 to support the breast 439. Breast compression device 430 further includes a front paddle 434. The breast 439 is compressed by front paddle 434 when the breast 439 is placed between back plate 432 and front paddle 434. Front paddle 434 is comprised of at least two fingers 436, with a U-shaped space in between that provides access to the breast tissue by a biopsy device. The fingers 436 are independently adjustable to allow fine adjustment of the compression as necessar -. Breast compression device 430 further includes an adjuster 438 to adjust the interior spacing of the device, shown in FIG. 66 as adjustment sleeve 440.

[00304] Referring now to FIG. 67, a top view of a breast compression device 442 according to a second embodiment is shown. In one embodiment, breast compression device 442 does not include an adjuster to adjust the interior spacing of the device. Rather, breast compression device 442 includes a bar 444 mat connects back plate 432 and front paddle 434. Breast compression device 442 may be comprised of a single sheet of material that has elastic or spring-like properties. In the second embodiment, the material itself provides the compressive force against the breast 439.

[00305] In a third embodiment, breast compression device 442 includes both bar 444 and adjuster 438 to adjust the interior spacing of the device. In the third embodiment, breast compression device 442 may be comprised of a single sheet of material that has elastic or spring-like properties to provide the compressive force against the breast 439.

[00306] Referring now to FIG. 68, a top view of a breast compression device 442 according to FIG. 67 illustrating compression of breast 439 is shown. The breast compression device 442 may be wrapped around the breast 439 from any direction or angle and allow for access of both an ultrasound probe and a biopsy device, as needed for a biopsy procedure.

[00307] Referring now to FIG. 69, a front view of a breast compression device 442 according to FIG. 67 illustrating compression of a breast 439 is shown. In this illustration, the breast compression device 442 has been wrapped around the breast 439 from the front of the breast 439.

[00308] Referring now to FIG. 70, a top view of a breast compression device 442 with a partial side view of a biopsy device 446 is shown. The biopsy device 446 has access to the breast 439 through the U-shaped space in between fingers 436. The open space in the area above the breast 439 and the breast compression device 442 provides unrestricted access for an ultrasound probe (not shown).

[00309] The invention will now be discussed with reference to the clauses listed below. It should be noted that the present invention may comprise the following clauses in any combination, even if not specifically listed.

[00310] 1. An excision device comprising:

a housing;

a stylet coupled to the housing and having a tip containing at least one blade;

a hollow central passageway extending through the center of the housing and the stylet;

a localization needle coupled to the stylet and being slidably disposed within a central passageway; and

an expanding cannula comprising:

a body having a first end and a second end, the first end coupled to the housing, and an expanding coring mechanism coupled to the second end of the body, the expanding coring mechanism including:

an annular spring,

a plurality of formed fingers extending between the annular spring and the second end of the body, and

a retractable flexible blade extending from the second end of the body and over the annular spring.

[00311] 2. The excision device of clause 1, wherein the annular spring is configured in a compressed state.

[00312] 3. The excision device of clause 1, wherein the annular spring is configured in an expanded state.

[00313] 4. The excision device of clause 1, wherein the body is 8 mm in diameter.

[00314] 5. The excision device of clause 1, wherein the expanding coring mechanism is advanced by a motor drive.

[00315] 6. The excision device of clause 1, wherein the formed fingers define a cavity between the body and the annular ring for collecting a tissue sample from a target tissue

[00316] 7. The excision device of clause 1, wherein the retractable flexible blade has at least one exposed edge for cutting the tissue sample as the expanding coring mechanism is advanced into the target tissue

[00317] 8. An expanding cannula of an excision device, the expanding cannula comprising:

a body having a first end and a second end, the first end being coupled to the excision device; and

an expanding coring mechanism coupled to the second end of the body, the expanding coring mechanism including:

an annular spring,

a retractable flexible blade extending from the second end of the body and over the annular spring. [00318] 9. The expanding cannula of clause 8, wherein the annular spring is configured in a compressed state.

[00319] 10. The expanding cannula of clause 8, wherein the annular spring is configured in an expanded state.

[00320] 11. The expanding cannula of clause 8, wherein the body is 8 mm in diameter.

[00321] 12. The expanding cannula of clause 8, wherein the expanding coring mechanism is advanced by a motor drive.

[00322] 13. The expanding cannula of clause 8, wherein the formed fingers define a cavity between the body and the annular ring for collecting a tissue sample from a target tissue

[00323] 14. The expanding cannula of clause 8, wherein the retractable flexible blade has at least one exposed edge for cutting the tissue sample as the expanding coring mechanism is advanced into the target tissue

[00324] IS. A method for excising tissue using an expanding cannula of an excision device, the method comprising:

introducing a bladed stylet coupled to the excision device into a target tissue;

retracting the bladed stylet to expose a distal end of an expanding cannula coupled to the excision device;

rotating the expanding cannula using a motor drive to advance the expanding cannula into the target tissue; and

collecting a tissue sample with the expanding cannula

[00325] 16. The method of clause IS, further comprising retracting the expanding cannula from the target tissue.

[00326] 17. The method of clause IS, wherein the expanding cannula includes an expanding coring mechanism

[00327] 18. The method of clause 17, wherein the expanding coring mechanism comprises an annular spring that expands in diameter as the expanding cannula is advanced into the target tissue.

[00328] 19. The method of clause 18, wherein the expanding coring mechanism includes a flexible blade that rotates axially to cut a core of tissue from the target tissue as the expanding cannula is advanced into the target tissue. [00329] 20. A method for excising tissue using an expanding cannula of an excision device, the method comprising:

rotating the expanding cannula using a motor drive to advance an expanding coring mechanism into the target tissue;

collecting a tissue sample wi th the expanding coring mechanism; and

retracting the expanding cannula from the target tissue.

[00330] 21. The method of clause 20, wherein the expanding coring mechanism comprises an annular spring that expands in diameter as the expanding cannula is advanced into the target tissue.

[00331] 22. The method of clause 21, wherein the expanding coring mechanism includes a flexible blade that rotates axially to cut a core of tissue from the target tissue as the expanding cannula is advanced into the target tissue.

[00332] 23. An incision expander comprising:

a housing;

an expanding cannula coupled to the housing;

a mechanism coupled to the housing and the expanding cannula and being configured to expand the expanding cannula; and

a removable bladed stylet extending through the center of housing and the expanding cannula

[00333] 24. The incision expander of clause 23, wherein the housing is cylindrical.

[00334] 25. The incision expander of clause 23, wherein the mechanism to expand the expanding cannula comprises one or more levers.

[00335] 26. The incision expander of clause 23, wherein the expanding cannula is cylindrical.

[00336] 27. The incision expander of clause 23, wherein the actuation of the mechanism to expand the expanding cannula increases the diameter of the expanding cannula

[00337] 28. The incision expander of clause 23, wherein the expanding cannula is comprised of a metal. [00338] 29. The incision expander of clause 23, wherein the expanding cannula is comprised of a polymer.

[00339] 30. An incision expander comprising:

a housing;

a cannula coupled to the housing; and

a tapered stylet extending through the center of housing and the expanding cannula

[00340] 31. The incision expander of clause 30, wherein the housing is cylindrical.

[00341] 32. The incision expander of clause 30, wherein the expanding cannula is cylindrical.

[00342] 33. The incision expander of clause 30, wherein the expanding cannula is comprised of a metal.

[00343] 34. The incision expander of clause 30, wherein the expanding cannula is comprised of a polymer.

[00344] 35. A method for introducing an excision device through a skin incision, the method comprising:

introducing a bladed stylet into a target tissue, the bladed stylet extending through the center of an incision expander, the incision expander comprising a housing and an expanding cannula;

actuating a mechanism to expand the expanding cannula, the mechanism being coupled to the housing and the expanding cannula;

retracting the bladed stylet from the incision expander; and

introducing an excision device into the target tissue through the center of the incision expander.

[00345] 36. The method of clause 35, wherein the mechanism to expand the expanding cannula comprises one or more levers.

[00346] 37. The method of clause 35, wherein the actuation of the mechanism to expand the expanding cannula increases the diameter of the expanding cannula

[00347] 38. The method of clause 35, further comprising collecting a tissue sample with the excision device from the target tissue.

[00348] 39. The method of clause 38, further comprising retracting the excision device from the target tissue. [00349] 40. A tissue excision system, the system comprising:

an excision device comprising:

a housing coupled to a coring cannula,

a stylet coupled to the housing and having a tip containing at least one blade, a hollow central passageway extending through the center of the housing, the coring cannula, and the stylet,

a guide rod assembly removably coupled to the housing; and

an incision expander coupled to the excision device, the incision expander comprising:

a housing,

an expanding cannula coupled to the housing,

a mechanism coupled to the housing and the expanding cannula and being configured to expand the expanding cannula, and

wherein the stylet extends through the center of the housing of the incision expander and the expanding cannula.

[00350] 41. A breast compression device comprising:

a back plate;

a front paddle comprising two or more fingers; and

an adjuster to adjust the space between the back plate and the front paddle.

[00351] 42. The breast compression device of clause 41, further comprising a U- shaped space between the two or more fingers.

[00352] 43. The breast compression device of clause 41, wherein the two or more fingers are independently adjustable.

[00353] 44. The breast compression device of clause 41, wherein the adjuster comprises an adjustment sleeve.

[00354] 45. A breast compression device comprising:

a back plate;

a front paddle comprising two or more fingers; and

a bar connecting the back plate and the front paddle.

[00355] 46. The breast compression device of clause 45, further comprising a U- shaped space between the two or more fingers. [00356] 47. The breast compression device of clause 45, wherein the two or more fingers are independently adjustable.

[00357] 48. The breast compression device of clause 45, wherein the breast compression device comprises a single sheet of material.

[00358] 49. The breast compression device of clause 45, wherein the breast compression device is comprised of a spring-like material.

[00359] 50. A method for compressing breast tissue with a breast compression device, the method comprising:

wrapping the breast compression device around the breast tissue from any angle, the breast compression device including:

a back plate,

a front paddle comprising two or more fingers, and

a bar connecting the back plate and the front paddle; and

adjusting the breast compression device to provide enough compression to render the breast tissue immobile.

[00360] 51. The method of clause 50, wherein adjusting the breast compression device comprises adjusting at least one of the two or more fingers.

[00361] 52. The method of clause 50, wherein the breast compression device further comprises an adjuster.

[00362] 53. The method of clause 52, wherein adjusting the breast compression device comprises adjusting at the adjuster.

[00363] 54. The method of clause 53, wherein the adjuster comprises an adjustment sleeve.

[00364] 55. The method of clause 50, wherein the breast compression devices further includes a U-shaped space between the two or more fingers.

[00365] 56. The method of clause 55, further comprising introducing a biopsy device to the breast tissue through the U-shaped space.

[00366] 57. The method of clause 50, wherein the breast compression device comprises a single sheet of material.

[00367] 58. The method of clause 50, wherein the breast compression device is comprised of a spring-like material.

[00368] 59. A tissue excision system, the system comprising: an excision device comprising:

a housing coupled to a coring cannula,

a guide rod assembly removably coupled to the housing; and

a breast compression device comprising:

a back plate,

a front paddle comprising two or more fingers, wherein the stylet of the excision device is advanced to a target tissue between the two or more fingers, and

an adjuster to adjust the space between the back plate and the front paddle.

[00369] Any modifications and variations of the present invention are possible in light of the above teachings. The invention may be practiced otherwise than as specifically described within the scope of the appended claims.

Claims

CLAIMS What is claimed is:

1. An excision device comprising:

a housing coupled to a coring cannula

a stylet coupled to the housing and having a tip containing at least one blade;

a hollow central passageway extending through the center of the housing, the coring cannula, and the stylet;

a guide rod assembly removably coupled to the housing, the guide rod assembly including:

a guide element having a guide rod slidably disposed within a central passageway and a locking member, the guide element having first and second ends, the locking member being fixed to the second end of the guide rod,

an anchor stabilization rod having first and second ends, the anchor stabilization rod slidably disposed within the central passageway, and

a coupling device having a first portion and a second portion, the first portion being fixed to the first end of the guide rod and the second portion being fixed to the first end of the anchor stabilization rod, the coupling device to removably couple the anchor stabilization rod to the guide rod.

2. The excision device of claim 1, wherein the locking member is composed of a plurality of wires having the predefined shape, and at least one of the wires is detachable from the locking member.

3. The excision device of claim 1, wherein the guide element is composed of a metal alloy of nickel and titanium.

4. The excision device of claim 3, wherein the metal allow is nitinol.

5. The excision device of claim 1, wherein the coupling device comprises a hook on the guide rod and a loop on the anchor stabilization rod.

6. The excision device of claim 1, wherein the coupling device comprises a plurality of mating notches on the guide rod and the anchor stabilization rod.

7. The excision device of claim 1, wherein the coupling device comprises a wireform attachment on the anchor stabilization rod and a tube in the guide rod.

8. The excision device of claim 7, wherein:

the wireform attachment includes a plurality of convex curves,

the guide rod is hollow and includes a plurality of apertures and an opening, and the wireform attachment is compressed and inserted into the opening, wherein the wireform attachment expands when it reaches the plurality of apertures and the convex curves engage with the apertures to form a cross-hold between the wireform attachment and the guide rod.

9. The excision device of claim 1, wherein the anchor stabilization rod further comprises a knob on the second end.

10. The excision device of claim 9, wherein the knob is coupled to a fixed support arm.

11. A guide rod assembly of an excision device, the guide rod assembly comprising: a guide element having a guide rod slidably disposed within a central passageway of the excision device and a locking member, the guide element having first and second ends, the locking member being fixed to the second end of the guide rod;

an anchor stabilization rod having first and second ends, the anchor stabilization rod slidably disposed within the central passageway; and

12. The guide rod assembly of claim 11, wherein the locking member is composed of a plurality of wires having the predefined shape, and at least one of the wires is detachable from the locking member.

13. The guide rod assembly of claim 11, wherein the guide element is composed of a metal alloy of nickel and titanium.

14. The guide rod assembly of claim 13, wherein the metal allow is nitinol.

15. The guide rod assembly of claim 11, wherein the coupling device comprises a hook on the guide rod and a loop on the anchor stabilization rod.

16. The guide rod assembly of claim 11, wherein the coupling device comprises a plurality of mating notches on the guide rod and the anchor stabilization rod.

17. The guide rod assembly of claim 11, wherein the coupling device comprises a wireform attachment on the anchor stabilization rod and a tube in the guide rod, wherein the wireform attachment is inserted into the tube and engages the guide rod to the anchor stabilization rod.

18. The guide rod assembly of claim 11, wherein the anchor stabilization rod further comprises a knob on the second end.

19. The guide rod assembly of claim 18, wherein the knob is coupled to a fixed support arm.

20. A guide rod assembly of an excision device, the guide rod assembly comprising: a guide element having a guide rod slidably disposed within a central passageway of the excision device and a locking member, the guide element having first and second ends, the locking member being fixed to the second end of the guide rod;

an anchor stabilization rod having first and second ends, the anchor stabilization rod slidably disposed within the central passageway; a coupling device having a first portion and a second portion, the first portion being fixed to the first end of the guide rod and the second portion being fixed to the first end of the anchor stabilization rod, the coupling device to removably couple the anchor stabilization rod to the guide rod; and

a fixed arm support removably coupled to the second end of the anchor stabilization rod.

21. The guide rod assembly of claim 20, wherein the fixed arm support is attached to a stationary object.

22. A method for preventing movement of a tissue anchor of an excision device during tissue excision, the method comprising:

advancing a first end of a guide rod into a target tissue;

introducing a first end of an anchor stabilization rod into an excision device;

coupling the first end of the anchor stabilization rod to the second end of the guide rod inside the excision device; and

controlling movement of the guide rod within the target tissue with a knob coupled to a second end of the anchor stabilization rod.