专利摘要:
CHAMBER OF ACCESS AND MARKERS FOR A BIOPSY DEVICE. The present invention relates to a marker implantation tool that can comprise a marker cannula having a lateral implant opening, a pusher slidably arranged inside the marker cannula and a stepped tip coupled to the distal end of the cannula. highlighter. The stepped tip may have a pusher recess configured to receive a portion of the distal end of the pusher, such that the pusher does not extend appreciably out of the lateral implant opening when the pusher is driven distally. The marker implantation tool can still comprise a magnet at or near the distal end. This magnet can be used in combination with a magnet or plurality of magnets arranged around an access chamber in a tissue sample holder to help the user align the marker implantation tool. The access chamber in the tissue sample holder can also include a valve, two valves or a removable plug.
公开号:BR112014002715B1
申请号:R112014002715-3
申请日:2012-07-27
公开日:2020-12-08
发明作者:Kevin M. Fiebig;Jessica P. Leimbach;Kyle P. Moore;Morgan R. Hunter;Andrew P. Nock
申请人:Devicor Medical Products, Inc.;
IPC主号:
专利说明:

BACKGROUND
[0001] Biopsy samples were obtained in a variety of ways in various medical procedures using a variety of devices. Biopsy devices can be used under simple visual guidance, palpation guidance, stereotaxic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance or otherwise. For example, some biopsy devices may be fully operable by a user using a single hand, and with a single insert, to capture one or more biopsy samples from a patient. In addition, some biopsy devices can be connected to a vacuum module and / or control module, such as for fluid communication (for example, pressurized air, saline, atmospheric air, vacuum, etc.), for energy communication and / or for communicating commands and the like. Other biopsy devices may be fully or at least partially operable without being powered on or otherwise connected to another device.
[0002] Only exemplary biopsy devices are disclosed in US patent 5,526,822, entitled "Method and apparatus for automated biopsy and collection of soft tissue," issued on June 18, 1996; US patent 6,086,544, entitled "Control apparatus for an automated surgical biopsy device", issued July 11, 2000; US publication 2003/0109803, entitled "MRI Compatible surgical biopsy device," published on June 12, 2003; US publication 2006/0074345, entitled "Biopsy apparatus and method," published April 6, 2006; US publication 2007/0118048, entitled "Remote thumbwheel for a surgical biopsy device," published on May 24, 2007; US publication 2008/0214955, entitled "Presentation of biopsy sample by biopsy device", published September 4, 2008; US publication 2009/0171242, entitled "Clutch and valving system for tetherless biopsy device," published on July 2, 2009; US publication 2010/0152610, entitled "Hand actuated tetherless biopsy device with pistol grip", published on June 17, 2010; US publication 2010/0160819, entitled "Biopsy device with central thumbwheel," published on June 24, 2010; US publication 2010/0317997, entitled "Tetherless biopsy device with reusable portion," published on December 16, 2010; US patent application 12 / 953,715, entitled "Handheld biopsy device with needle firing," filed on November 24, 2010; US patent application 13 / 086,567, entitled "Biopsy device with motorized needle firing," filed on April 14, 2011; US patent application 13 / 099,497, entitled "Biopsy device with manifold alignment feature and tissue sensor," filed on May 3, 2011; and US patent application 13 / 150,950, entitled "Needle assembly and blade assembly for biopsy device," filed on June 1, 2011. The disclosure of each of the US patents, US patent application publications, and non-provisional patent applications US above is incorporated by reference here.
[0003] In some scenarios, it may be desirable to mark the location of a biopsy site for additional reference. In addition, it may be preferable to be able to access the biopsy site while the biopsy device is still located on the patient to precisely mark the biopsy site. Therefore, one or more markers can be deposited at a biopsy site before, during, or after a tissue sample is taken from the biopsy site.
[0004] In some cases, biopsy devices have been adapted to allow marking of a side entry on the biopsy probe. Depending on the location of the access point and the release through the device, the marker implantation device can be a flexible, semi-rigid, or rigid implantation device. Some exemplary marker implantation tools include MAMMOMARK ™, MICROMARK® and CORMARK ™ branded devices from Devicor Medical Products, Inc. of Cincinnati, Ohio. Additional exemplary devices and methods for marking a biopsy site are revealed in US publication 2009/0209854, entitled "Biopsy method," published on August 20, 2009; US publication 2009/0270725, entitled "Devices useful in imaging," published October 29, 2009; US publication 2010/0049084, entitled "Biopsy marker delivery device," published on February 25, 2010; US publication 2011/0071423, entitled "Flexible biopsy marker delivery device," published on March 24, 2011; US publication 2011/0071424, entitled "Biopsy marker delivery device," published on March 24, 2011; US publication 2011/0071391, entitled "Biopsy marker deliver device with positioning component," published on March 24, 2011; US publication 2011/0071431, entitled "Biopsy marker delivery device," published on March 24, 2011; US patent 6,228,055, entitled "Devices for marking and defining particular locations in body tissue," issued May 8, 2001; US patent 6,371,904, entitled "Subcutaneous cavity marking device and method", issued April 16, 2002; US patent 6,993,375, entitled "Tissue site markers for in vivo imaging," issued January 31, 2006; US patent 6,996,443, entitled "Imageable biopsy site marker," issued February 7, 2006; US patent 7,044,957, entitled "Devices for defining and marking tissue," issued May 16, 2006; US patent 7,047,063, entitled "Tissue site markers for in vivo imaging," issued May 16, 2006; US patent 7,229,417 entitled "Methods for marking a biopsy site," issued June 12, 2007; and US patent 7,465,279, entitled "Marker device and method of deploying a cavity marker using a surgical biopsy device," issued December 16, 2008. The disclosure of each of the above US patents and US patent application publications is incorporated for reference here.
[0005] Although several systems and methods have been made and used to obtain a biopsy sample, it is believed that no one before the inventors made or used the invention described in the attached claims. BRIEF DESCRIPTION OF THE DRAWINGS
[0006] Although the specification concludes with claims that particularly indicate and distinctly claim the invention, it is believed that the present invention is better understood from the following description of certain examples taken in combination with the accompanying drawings, in which numerals of Similar reference numbers identify the same elements. In the drawings some components or portions of components are shown in spectrum as represented by broken lines.
[0007] FIG. 1 represents a perspective view of an exemplary biopsy device showing an exemplary probe attached to an exemplary holster; FIG. 2 represents a perspective view of an exemplary sample device showing an exemplary probe uncoupled from an exemplary holster; FIG. 3 represents a cross-sectional view of an exemplary tissue sample holder; FIG. 4 represents a perspective view of an exemplary rotating pipeline; FIG. 5 represents a cross-sectional view of an exemplary tissue sample holder having an internal valve and an external valve and coupled to a probe; FIG. 6 represents a cross-sectional view of an exemplary alternative tissue sample holder having a single valve; FIG. 7 represents a cross-sectional view of yet another exemplary tissue sample holder and an exemplary removable plug; FIG. 8 represents a partial cross-sectional view of the tissue sample holder of FIG. 7 with an exemplary luer check valve; FIG. 9 represents a top view of an exemplary tray for use with a swivel tubing of a tissue sample holder; FIG. 10 represents a side view of an exemplary marker implantation tool; FIG. 11 represents an enlarged perspective view of an exemplary scalloped tip of the exemplary marker implantation tool of FIG. 10; FIG. 12 represents an enlarged perspective view of an exemplary alternative stepped tip; FIG. 13 represents an enlarged alternative view of an exemplary marker implantation tool having a magnet; and FIG. 14 represents a rotating pipe with complementary magnets.
[0008] The drawings are not intended to be in any way limiting, and it is considered that various embodiments of the invention can be realized in a variety of other ways, including those not necessarily represented in the drawings. The attached drawings incorporated into and that form a part of the specification illustrate various aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise provisions shown. DETAILED DESCRIPTION
[0009] The following description of certain examples of the invention should not be used to limit the scope of the present invention. Other examples, characteristics, aspects, modalities and advantages of the invention will become evident to those skilled in the art from the following description, which is by way of illustration, one of the best ways considered for carrying out the invention. As will be noticed, the invention is capable of other different and obvious aspects, all without departing from the invention. Therefore, drawings and descriptions should be considered as illustrative and not restrictive. 1. Overview of the exemplary biopsy device
[00010] FIG. 1 shows an exemplary biopsy device 10. The biopsy device 10 comprises a probe 20 and a holster 30. Probe 20 has a needle 40 that extends distally from a housing 80 of probe 20 and is insertable into a patient's tissue to obtain tissue samples, as will be described below. The biopsy device 10 further comprises a tissue sample holder 100 on which the tissue samples are deposited. Just as an example, probe 20 can be a disposable component and holster 30 can be a reusable component to which probe 20 can be attached, as shown in FIG. 2. The use of the term "holster" here should not be read as requiring that any portion of probe 20 be inserted into any portion of holster 30. Indeed, in a biopsy device 10 configuration, probe 20 can simply be positioned on top holster 30. Alternatively, a portion of probe 20 can be inserted into holster 30 to attach probe 20 to holster 30. In yet another version, a portion of holster 30 can be inserted into probe 20. Still in addition, probe 20 and holster 30 can be integrally formed as a single unit. In versions where probe 20 and holster 30 are separable elements, a hole and / or seal can be provided in holster 30 to couple with a second orifice and / or second seal on probe 20 such that the vacuum produced by a pump the vacuum coupled to holster 30 can be connected fluidly to probe 20. Indeed, in a purely exemplary version, the vacuum pump induces a vacuum on needle 40 as will be described in more detail below. The vacuum pump can be coupled by vacuum tubes to appropriate orifices in the biopsy device 10. Other structural and functional combinations suitable for probe 20 and holster 30 will be apparent to a person skilled in the art in view of the teachings of the present invention. 11. Exemplary probe
[00011] As described above, probe 20 has a needle 40 extending distally from probe 20 and a tissue sample holder 100 coupled to a proximal end of probe 20. A. Exemplary spirit level
[00012] In certain situations, it may be desirable for a user to align or maintain the level of the biopsy device 10 during a procedure. A purely exemplary situation can occur during an MR biopsy when using a targeting grid with a biopsy device 10. Merely exemplary biopsy device grids are disclosed in patent application US 12 / 485,119, entitled "Biopsy targeting cube with elastomeric edges," filed on June 16, 2009; US patent application 12 / 485,138, entitled "Biopsy targeting cube with elastomeric body," filed on June 16, 2009; US patent application 12 / 485,168, entitled "Biopsy targeting cube with malleable members," filed on June 16, 2009; US patent application 12 / 485,278, entitled "Biopsy targeting cube with angled interface," filed on June 16, 2009; and US patent application 12 / 485,318, entitled "Biopsy targeting cube with living hinges," filed on June 16, 2009. The disclosure of each of the aforementioned US patent applications is incorporated by reference here. When using one of these exemplary grids, it may be useful to maintain the level of the biopsy device 10 to adequately target a tissue lesion for sampling. For example, by maintaining the level of the biopsy device 10 with one of the exemplary gratings, the accuracy of targeting an injury can be increased by reducing the possibility of tipping while inserting the biopsy device 10 into the patient's tissue. Therefore, a leveling device for biopsy device 10 can be useful for the user during such situations.
[00013] The enclosure 80 of the present example can comprise a leveling device 86 coupled to an outer surface 82 of the enclosure 80. In the example shown in FIG. 1, the leveling device 86 is shown as a bull's-eye bubble level attached to the top of the outer surface 82 of the casing 80, although it should be understood that the present configuration is merely exemplary. Indeed, the leveling device 86 may alternatively comprise a single tubular bubble level, a pair of orthogonal tubular bubble levels, or any other appropriate leveling device 86 as will be apparent to a person skilled in the art in view of the teachings of the present invention. . In some situations where two levels of orthogonal tubular bubble are used, a first level of tubular bubble can be attached to one side of the outer surface 82 while the second level of tubular bubble can be attached to a proximal end of the outer surface 82. In this configuration , the first tubular bubble level is configured to determine whether the biopsy device 10 is longitudinally leveled and the second tubular bubble level is configured to determine whether the biopsy device 10 is laterally leveled. Alternatively, in the version having the bull's-eye bubble level shown in FIG. 1, the single bull's-eye level is configured to determine whether the biopsy device 10 is both longitudinally and laterally level. In addition, the leveling device 86 can be integrated into the casing 80, adhesively attached to the outer surface 82, loosely coupled to the outer surface 82, or coupled to the casing 80 in any other appropriate method as will be apparent to a person skilled in the art in view the teachings of the present invention. In a further alternative, the leveling device 86 can be coupled to holster 30, tissue sample holder 100 or needle 40 to indicate when the biopsy device 10 is longitudinal and / or laterally leveled.
[00014] Although some merely exemplary configurations for housing 80 have been described, other configurations equally suitable will be apparent to a person skilled in the art in view of the teachings of the present invention. B. Exemplary needle for exemplary probe
[00015] The needle 40 of the present example includes a cannula 42, a distal tip 44, and a lateral opening 46 proximal to the distal tip 44. The distal tip 44 shown in FIGS. 1-2 is configured to pierce and penetrate the tissue without requiring a high amount of force or requiring an opening to be preformed in the tissue prior to insertion of distal tip 44, although it should be understood that distal tip 44 may have other configurations appropriate, including a blunt tip. The distal tip 44 may comprise a blade assembly for attaching a flat blade to cannula 42, as described in US patent application 13 / 150,950, entitled "Needle assembly and blade assembly for biopsy device," filed on June 1, 2011 , the disclosure of which is hereby incorporated by reference. Still other configurations equally suitable for the distal tip 44 will be apparent to those skilled in the art in view of the teachings of the present invention.
[00016] The needle 40 of the present example is also coupled to a pair of indicators 72 shown in indicator windows 70 of housing 80. Indicators 72 can be rotating drums having a plurality of markings, such as numbers, letters, and / or colors to provide an indication to a user of needle orientation 40. In the present example, indicators 72 are coupled to gears that engage with a complementary gear in a proximal portion of needle 40 such that when needle 40 is rotated around its longitudinal geometric axis, through a user using an adjustment wheel or by a motor, indicators 72 then rotate as well. In a purely exemplary version, indicators 72 can be aligned and have a plurality of markings to indicate the position of the side opening hours 46. In an alternative version, indicators 72 can indicate the orientation of the distal tip 44. Still additional settings for indicators 72 will be evident to those skilled in the art in view of the teachings of the present invention.
[00017] Needle 40 can be further divided into a first lumen 94 and a second lumen 96. Such an exemplary configuration for needle 40 is described in US patent application 13 / 150,950, entitled "Needle assembly and blade assembly for biopsy device, "deposited on June 1, 2011. In one version, needle 40 can be a tube of ovular cross section having a cut-out portion that extends longitudinally from the distal end of needle 40 and ending in a proximal position of the distal end. For example, the cutout portion may extend longitudinally along the entire length of needle 40 or the cutout portion may terminate in a longitudinal position less than needle length 40 and distal from the proximal end of needle 40. A tube in circular cross section it can be fixed where the cut portion was removed; the inside of the tube in circular cross section defining a first lumen 94 and the combination of the outside of the tube in circular cross section and a partial section of the needle 40 defining a second lumen 96 parallel to the first lumen 94. Alternatively, a longitudinal wall (not shown) ) can be inserted into needle 40 and fixed inside needle 40. The upper region of needle 40 and the longitudinal wall defining the first lumen 94 and the lower region of needle 40 and the longitudinal wall defining the second lumen 96. A plurality of openings can be formed in the longitudinal wall or tube in circular cross section to allow fluid communication between the first lumen 94 and second lumen 96. Still other suitable configurations for the needle 40 having a first lumen 94 and a second lumen 96 will be evident for a person skilled in the art in view of the teachings of the present invention.
[00018] Lateral opening 46 is located proximally to distal tip 44 and is sized to receive tissue when needle 40 is inserted into a patient's tissue. A tubular cutter 90 is disposed in the first lumen 94 of the needle 40 and is operable to rotate and / or rotate with respect to the needle 40 to cut the fabric projecting through the side opening 46. The tubular cutter 90, as partially shown in FIG . 3, comprises a sharp distal end and defines a cutter lumen 98 therein. In the present example, the tubular cutter 90 is driven by a motor, although it should be understood that the tubular cutter 90 can be driven by a variety of mechanical or electromechanical components, such as a pneumatic system, a spring driven system, or any other component appropriate. The tubular cutter 90 is configured to drive between a more distal position, in which the tubular cutter 90 substantially blocks access through the side opening 46 resulting in a "closed" side opening 46, and a more proximal position, in which a distal end of the tubular cutter 90 is proximal to a proximal edge of side opening 46 resulting in an "open" side opening 46. Thus, when side opening 46 is in an open position, the fabric can be pulled through side opening 46 and inward of the cannula 42, thereby allowing the tubular cutter 90 to be advanced distally to cut a tissue sample with the sharp distal end. In addition, although the side opening 46 is in an "open" position, items from inside the cannula 42 or elsewhere in the biopsy device 10 can be expelled out through the side opening 46 and into a patient's tissue or to inside a cavity formed after a tissue sample has been removed. Merely exemplary items that can be expelled through the side opening 46 include medication, saline, portions or other medical devices, biopsy site markers, or any other appropriate item as will be evident to a person skilled in the art in view of the teachings of this invention.
[00019] When the biopsy device 10 is operated, the second lumen 96 can be configured to selectively deliver atmospheric air, vacuum and / or saline to the cutter lumen 98. The plurality of openings described above can be arranged in such a way that at least one opening is located in a longitudinal position that is distal from the distal edge of the side opening 46 such that the cutter lumen 98, first lumen 94, and second lumen 96 remain in fluid communication even when the tubular cutter 90 it is advanced to the most distal position. In a purely exemplary operational mode, when a tissue sample is cut by the tubular cutter 90, a vacuum can be applied to the cutter lumen 98 while atmospheric air is supplied via a vent fluidly coupled to the first lumen 94 and / or second lumen 96. The combination of vacuum on one side of the tissue sample and atmospheric air on the other can cooperatively induce the tissue sample proximally through the tubular cutter 90 and toward the tissue sample holder 100. Alternatively, when no samples of tissue is present on needle 40, saline can be discharged through cutter lumen 98, first lumen 94, and second lumen 96 to clean any residue on it. A valve mount can be provided on probe 20 or holster 30 to selectively switch between the various configurations. Such a valve assembly can be constructed in accordance with at least some of the teachings of US publication 2010/0317997, entitled "Tetherless biopsy device with reusable portion", published on December 16, 2010; in accordance with the teachings of US patent application 12 / 953,715, entitled "Handheld biopsy device with needle firing," filed on November 24, 2010; and / or otherwise. Alternatively, in the present example, a separate control module can be provided that has internal controls to selectively apply vacuum, saline, and / or atmospheric air. Such a control module can be built according to at least some of the teachings of US publication 2010/0160817, entitled "Control module interface for MRI Biopsy device," published on June 24, 2010. Other versions, characteristics, components, configurations and appropriate alternative functionalities of needle 40 will be apparent to those skilled in the art in view of the teachings of the present invention. C. Exemplary tissue sample holder
[00020] In some situations it may be useful to have access to the cutter lumen, first lumen, and / or side opening of a biopsy device. As discussed above, such access may be desirable for expelling items out through the side opening into a patient's tissue or into a cavity formed in the tissue after excising a biopsy sample. Merely exemplary items that can be expelled include medication, saline, portions of other medical devices, biopsy site markers, or any other appropriate item. In certain situations, the only accessible portion of a biopsy device may be the proximal end of the device. Therefore, if a tissue sample holder is attached to the proximal end of the biopsy device, access through the tissue sample holder can be useful to expel one of the items mentioned above. In addition, it may also be preferable to provide selective access through the tissue sample holder in such a way that a vacuum can be provided prior to access to clean the residue biopsy device. In addition, by providing selective access through the tissue sample holder, the user may not need to remove and reattach the tissue sample holder each time access is desired, thereby possibly preserving sterility and maintaining ease of use of the device. Therefore, providing a chamber in the tissue sample holder through which access to the cutter lumen, first lumen and / or side opening is possible can be useful for a user of a biopsy device.
[00021] As seen in FIG. 3, an exemplary tissue sample holder 100 is loosely coupled to the proximal end of probe 20. The tissue sample holder 100 of the present example is configured to receive tissue samples which are cut by the tubular cutter 90 and communicated proximally via of the cutter lumen 98. The probe 20 of the present example comprises a transfer element 22 in fluid communication with the cutter lumen 98 on the needle 40 and a vacuum line 52 coupled to a vacuum pump. In the present example, transfer element 22 has a needle opening 24 and a vacuum opening 26. Transfer element 22 is configured to selectively connect needle 40 to a tray portion 158 of a selected chamber 150 and selectively connect to vacuum line 52 to a vacuum portion 156 of the selected chamber 150 such that vacuum line 52, selected vacuum portion 156, selected tray portion 158, and needle 40 are all in fluid communication. Just as an example, transfer element 22 can be made of a resilient material, such as rubber, synthetic rubbers (such as Neoprene), liquid silicone rubber, santoprene, or any other suitable material. The tissue sample holder 100 as shown in FIG. 3 further comprises one or more removable trays 400, an outer cover 120, and a rotating tubing 140. 1. Exemplary rotating piping
[00022] With reference now to FIG. 4, rotating tubing 140 comprises a plurality of chambers 150 positioned around a central hub 142 where each of the plurality of chambers 150 extends through rotating tubing 140. In the present example, thirteen chambers 150 are radially positioned around central hub 142 with at least one chamber configured to be an access chamber 160 and as will be described in more detail below. It is to be understood that more than thirteen or less than thirteen chambers 150 can be positioned radially around central hub 142. Central hub 142 is configured to couple with a portion of probe 20 such that rotating tubing 140 can be rotated in with respect to probe 20. The rotating tubing 140 may further comprise a distal flange 132 and a complementary groove 134 formed therein, as will be described in more detail below.
[00023] As shown in FIG. 3, the probe 20 of the present example comprises a rotating element 110 configured to be insertable in a central recess 144 of central hub 142. Just as an example, rotating element 110 comprises an axis 112 having a proximal end and a distal end, a tubing gear 114 attached to the distal end of the shaft 112, a shaft recess 116 extending distally from the proximal end, and a transverse groove 117, shown in FIG. 5, located at the proximal end of the shaft 112. In the present version, the shaft recess 116 is configured to receive a pipe shaft 146 and transverse groove 117 is configured to mate with a groove element 148 such that the rotating pipe 140 can be rotated when the tubing gear 114 of the rotating element 110 is rotated. Probe 20 further comprises a claw 118 configured to selectively engage tubing gear 114. Claw 118 is configured to be propelled toward piping gear 114. When probe 20 is detached from holster 30, claw 118 engages to engage the tubing gear 114 and inhibits rotation of the rotating element 110. Conversely, when probe 20 is coupled to holster 30, claw 118 is disengaged from tubing gear 114 to allow rotation of rotating element 110. A purely exemplary configuration to disengage the claw 118 is a tongue extended out of holster 30.
[00024] Still with reference to FIG. 3, the central recess 144 is configured to receive a portion of the shaft 112 while the pipe shaft 146 is inserted into the shaft recess 116 and transverse groove 117 is coupled to the groove element 148. The claw 118 can retain the rotation element 110 in a stationary position while the shaft recess 116, transverse groove 117, pipe shaft 146 and groove element 148 are aligned. As a result of this alignment, a selected chamber 150 of the rotating tubing 140 is aligned with the needle opening 24 of the transfer element 22. In addition, this alignment may allow the biopsy device 10 to keep track of the orientation of the tissue sample holder 100 electronically (as with a control panel and appropriate programming) or mechanically (as with a numbered disc, drum or other marked physical element) even while switching between different tissue sample holders 100. With the tissue sample holder 100 attached to the probe 20, the pivot element 110 is operable to rotate the rotating tubing 140 using the engagement of the shaft recess 116, the transverse groove 117, tubing shaft 146, and the groove element 148. Additionally, an alignment pin recess ( not shown) can be included at the distal end of rotating tubing 140 to engage an alignment pin extending from the nearby end al of probe 20, such as that disclosed in US patent application 13 / 099,497, entitled "Biopsy device with manifold alignment feature and tissue sensor," filed on May 3, 2011, the disclosure of which is incorporated by reference here. The alignment pin can be configured to rotate proximally in response to movement close to the cutter 90 and, if the rotating tubing 140 is properly aligned, the alignment pin enters the recess of the alignment pin. The alignment pin recess can be configured to be a longitudinal tapered funnel such that if the rotating pipeline 140 is slightly angled, then movement near the alignment pin can engage the side walls of the tapered funnel to adjust the pipeline alignment. 140. Of course, other configurations equally suitable for the alignment pin and the alignment pin recess will be evident to those skilled in the art in view of the teachings of the present invention. i. Exemplary cameras
[00025] As mentioned above, FIG. 4 represents a plurality of chambers 150 positioned radially around the central hub 142. The rotating tubing 140 is rotatable in such a way that each chamber 150 can be selectively aligned with the needle opening 24 and vacuum opening 26. The chambers 150 of the present example are partial pie-shaped chambers extending substantially through rotating tubing 140, although it should be understood that chambers 150 may have other configurations. Merely exemplary alternative chambers 150 include circular chambers, square chambers, triangular chambers, or any other suitable format. The chambers 150 can also extend only partially through the rotating tubing 140 instead of fully through. In addition, as in the present example, a portion of the chamber 150 may extend fully through the rotating tubing 140 while a second portion does not. The chambers 150 are separated by a plurality of walls 152 such that each chamber 150 is substantially fluid insulated from the other chamber 150. Each wall 152 comprises a pair of flaps 154 that extends longitudinally along each chamber 150 and outwardly from wall 152. Flaps 154 are configured to support tissue sample containers 450, shown in FIGS. 3 and 9, of removable trays 400, as will be described later here. The interiors of chambers 150 are divided into a vacuum portion 156 and a tray portion 158. The vacuum portion 156 is defined by the portion of chamber 150 located between the central hub 142 and tabs 154. The tray portion 158 is defined by chamber portion 150 located between tabs 154 and an outer edge 180 of rotating tubing 140.
[00026] In a purely alternative version, a wall can be inserted in each chamber 150 where flaps 154 protrude, thereby physically defining the vacuum portion 156 and tray portion 158. Still in an additional alternative, the wall can be integrally formed in the rotating tubing 140. The wall in this version can include a plurality of openings to allow fluid communication between the tray portion 158 and the vacuum portion 156. Still in an additional version, a proximal wall can be formed at the proximal end of each chamber 150. A vacuum portion length 156 may extend vertically towards its proximal wall and the proximal wall may comprise a plurality of openings such that the proximal end of the tray portion 158 is in fluid communication with the vacuum portion 156. Vacuum portion 156 may also be omitted altogether or vacuum portion 156 may be located elsewhere on rotating tubing 140.
[00027] Still further, in another version, the rotating tubing 140 may include a disc with a plurality of chambers extending radially outward 150. Still in addition, the rotating tubing 140 may instead be a linear rotating tubing that includes vertical chambers and / or horizontal 150, or even in an additional version, a chamber matrix 150 can be supplied in a rectangular pipe. Of course, other configurations for rotating piping 140 will be evident to a person skilled in the art in view of the teachings of the present invention. ii. Exemplary access camera configurations
[00028] At least one chamber of the plurality of chambers 150 is configured to be an access chamber 160. The access chamber 160 of the present example is configured differently from the other chambers 150 although it should be understood that this is merely optional. In the present example, access chamber 160 comprises a tubular chamber extending through rotating tubing 140 and having recessed portions 162 at the distal and proximal ends that are configured to receive valve elements 164, 166. In a purely exemplary version shown in FIG . 5, the access chamber 160 comprises an internal valve 164 and an external valve 166. The internal valve 164 is located substantially at the distal end of the access chamber 160 and the external valve 166 is located substantially at the proximal end of the access chamber 160. Internal valve 164 can be configured to be a variety of different valve types, including duckbill valves, dome valves, cross groove valves, cross dome groove valves, and / or any other appropriate valve or combination of valves as will be evident to a person skilled in the art in view of the teachings of the present invention. The internal valve 164 and / or the lower portion 162 can be further configured to have a distal face lowered in such a way that the needle opening 24 and the vacuum opening 26 of the transfer element 22 can be in direct fluid communication distally from the internal valve 164 when the access chamber 160 is aligned with the transfer element 22. In that alignment, if a vacuum is applied by a vacuum pump, a vacuum path is formed the first lumen 94, through the cutter lumen 98, through the needle opening 24 of the transfer element 22 and through the vacuum opening 26 for the vacuum pump. Therefore, when the vacuum pump is activated and the access chamber 160 is aligned in this way, the first lumen 94, cutter lumen 98, needle opening 24 and vacuum opening 26 can be cleaned of any residue while the internal valve 164 isolates the access chamber 160 from the vacuum. In addition, saline, a combination of saline and vacuum, a medicinal drug, or any other suitable fluid can be applied along the same path while the access chamber 160 is fluidly isolated.
[00029] Outer valve 166 can be the same type of valve as inner valve 164 or outer valve 166 can be any other type of valve other than inner valve 164. Outer valve 166 provides a second outer seal for access chamber 160 to prevent objects from accidentally entering or leaving the access chamber 160. An item can be inserted through the external and internal valves 166,164 through the needle opening 24, through the cutter lumen 98, through the first lumen 94 and optionally, outward from the side opening 46 to access the cavity from which a biopsy sample was taken. With this version, access to the biopsy site is permissible through the proximal end of the biopsy device 10 while needle 40 is still inserted in the patient.
[00030] In an alternative version, shown in FIG. 6 the access chamber 260 can comprise a single valve 262 located at one point in the access chamber 260. For example, the single valve 262 can be located at the longitudinal midpoint of the access chamber 260. The single valve 262 can be configured to be a variety of different valve types, including duckbill valves, dome valves, cross groove valves, cross dome groove valves, and / or any other appropriate valve or combination of valves as will be evident to a knowledgeable person in the art in view of the teachings of the present invention. With single valve 262 in place, a vacuum can be aspirated by the vacuum pump through needle 40 while the access chamber 260 is aligned with the needle opening 24 without losing much, if any, vacuum through the access chamber 260. Therefore, the cutter lumen 98, first lumen 94, and second lumen 96 of the needle 40 can be cleaned of debris by applying vacuum while the access chamber 260 is aligned. An item can be inserted through single valve 262, through needle opening 24, through cutter lumen 98, through first lumen 94 and, if necessary, out of side opening 46 to access the cavity from which a sample of biopsy was removed. Thus, access to the biopsy site is also permissible while needle 40 is still inserted in the patient using this alternative version. Of course, with the aforementioned seals 164, 166, 262 they can be overmoulded or integrally formed for all access chambers 160, 260.
[00031] Yet another version for the access chamber 360) includes a removable plug 300 as shown in FIG. 7. In this version, access chamber 360 is a chamber substantially similar to access chamber 260 except that single valve 262 is omitted. The exemplary removable plug 300 comprises a cable 310 and an axis 320. The axis 320 is dimensioned to be insertable substantially over the entire length of the access chamber 360. Alternatively, the axis 320 may extend less than the total length of the access chamber 360 The shaft 320 may further include at least one annular sealing element 330 disposed about the shaft 320 at a distal point of the cable 310. In the example shown in FIG. 7, the removable plug 300 has a resilient annular sealing element 330 disposed around axis 320 at the distal end of axis 320. Axis 320 and resilient annular seal element 330 can be made of a resilient material, such as low polyethylene. LDPE density. A plurality of resilient annular sealing elements 330 can be arranged around axis 320 at a plurality of distal points of the cable 310. The annular sealing element 330 can alternatively be a flexible element that tapers as it extends outwardly from the shaft 320 to form a wiper seal. As with other components described herein, the shaft 320 and annular sealing element 330 may have any other suitable configuration as will be apparent to a person skilled in the art in view of the teachings of the present invention. Cable 310 is shown as a tongue extending from axis 320 having an enlarged portion at the proximal end. When the removable plug 300 is inserted into the access chamber 360, the removable plug 300 substantially seals the access chamber 360, thereby inhibiting the flow of fluid into or out of the biopsy device 10 through the access chamber 360. With the removable plug 300 inserted, a vacuum can be aspirated by the vacuum pump while the access chamber 360 is aligned with the needle opening 24 without losing much, if any, vacuum through the access chamber 360. Therefore, the opening of vacuum 26, needle opening 24, cutter lumen 98, first lumen 94 and / or second lumen 96 can be cleaned of debris by applying a vacuum before accessing the fabric through the side opening 42 through the access chamber 360.
[00032] A luer check valve 370 can alternatively be inserted into the access chamber 360, as shown in FIG. 8. The luer check valve 370 of the present example comprises a longitudinal passage 378, a seal 372 located substantially at a proximal end of the luer check valve 370, a luer lock connector 374 at a distal end of the luer check valve 370, and a valve 376 arranged in the longitudinal passage 378. The seal 372 is shown as a silicone or rubber O-ring seal that can prevent fluid from communicating proximally to the seal 372 when the luer check valve 370 is inserted into the access chamber 360 The luer lock connector 374 comprises a threaded portion for coupling to a complementary luer connection. The valve 376 is arranged distally from the luer lock connector 374 and is configured to substantially prevent fluids from entering or leaving the luer check valve 370 without applying any force to the fluid. When the luer check valve 370 is inserted into the access chamber 360, a vacuum can be sucked in by the vacuum pump while the access chamber 360 is aligned with the needle opening 24 without losing much, if any, vacuum through the access chamber. access 360. Consequently, the vacuum opening 26, needle opening 24, cutter lumen 98, first lumen 94, and / or second lumen 96 can be cleaned of residue by applying a vacuum before coupling a syringe or other item through of the luer lock connector 374. As an example only, when a syringe is attached to the luer lock connector 374, a medication contained in the syringe can be forced beyond valve 376 by pressing on a syringe plunger. If the needle opening 24 is opened for the tissue, the medication can be applied to the tissue without removing the biopsy device 10. It should be understood that items other than medication can be injected into the tissue, including contrast dyes, saline, gels , or other appropriate items that can be used as will be apparent to a person skilled in the art in view of the teachings of the present invention. Of course, the luer check valve 370 can alternatively be integrated into the rotating pipeline 140. Still in addition, the luer check valve 370 can include a spring-driven luer valve. As with other components described herein, the luer check valve 370 will be apparent to a person skilled in the art in view of the teachings of the present invention. 2. Exemplary removable trays
[00033] One or more removable trays 400, shown in FIG. 9, are configured to allow a user to remove cut tissue samples from tissue sample holder 100 without having to uncouple tissue sample holder 100 from probe 20. Each tray 400 comprises a main portion 410 and at least one container of tissue sample 450. Each tray 400 can be rigid, and can be preformed to match the generally arched configuration of rotating tubing 140 or alternatively, trays 400 can be formed of a flexible material, such that trays 400 can be curved or deformed to conform to the rotating piping configuration 140. Still further, the main portion 410 may be formed of a rigid material and coupled to a flexible material that forms at least one tissue sample container 450. Conversely, at least one container tissue sample 450 may be formed of a rigid material while the main portion 410 comprises a flexible material. In the example shown in FIG. 9, each tray 400 comprises a main portion 410 and six tissue sample containers 450, although it should be understood that any number of tissue sample containers 450 can be used. The main portion 410 of the present example comprises one or more joints 420, as living joints, such that parts of the main portion 410 can flex or bend at the joints 420. As shown in FIG. 9, each main portion 410 of trays 400 has two live hinge joints 420. Main portion 410 further comprises a cable 430 for a user to hold and maneuver tray 400. Cable 430 can be constructed of a rigid material so as not to flex when secured by a user carrying tray 400, and cable 430 can be located at the midpoint of the main portion 410 of each tray 400.
[00034] Each tissue sample container 450 of the present example has a base portion 452, a proximal end wall 454, a distal end cleaner wall 455, and a pair of container side walls 456, defining a sample container tissue sample 450. The tissue sample containers 450 can be integrally formed with the main portion 410, or tissue sample containers 450 can be mechanically or chemically attached to the main portion 410. The distal end cleaner wall 455 is sized to substantially fill the area of each chamber 150 such that when the tissue sample container 450 is removed from the rotating tubing 140, the distal end cleaner wall 455 removes pieces of tissue from the walls of the rotating tubing 140. In the example shown, a plurality of displacement elements 440 displaces the proximal end walls 454 from the main portion 410, although it should be understood that This is purely optional and the proximal end walls 454 can be directly coupled to main portion 410. The plurality of displacement elements 440 can include wiper blade type seals and can assist in sealing the tissue sample container 450 when inserted into the rotating tubing 140. As an example only, each tissue sample container 450 is configured to receive a single tissue sample cut by tubular cutter 90. Alternatively, tissue sample containers 450 can be configured in such a way that each sample container 450 can retain more than one tissue sample. Tissue sample containers 450 are configured to be insertable into chambers 150 of the rotating tubing 140 for use with the biopsy device 10. In the example shown, tissue sample containers 450 are inserted through the proximal end of the rotating tubing 140 in the portion tray 158 and are located on top of flaps 154. The base portion 452 has a plurality of openings 458 that allow fluid communication through the tissue sample container 450 into the vacuum portion 156 of the chamber 150. Therefore, when the tissue sample containers 450 are inserted into chambers 150, first lumen 94, cutter lumen 98, and needle opening 24 may be in fluid communication with vacuum line 52 through tissue sample container 450 from openings 458 , vacuum portion 156 and vacuum opening 26. Thus, after a tissue sample is cut by the tubular cutter 90, the tissue sample can be transported proximally p or vacuum pressure produced by the vacuum pump until the tissue sample is in the tissue sample container 450. After the tissue sample is stored in a tissue sample container 450, the rotating tubing 140 can be rotated by the rotating element 110 to align a new tissue sample container 450 with needle 40.
[00035] Each tray 400 may further comprise one or more types of markings or other signs to distinguish a tissue sample container 450 from another tissue sample container 450. For example, a number or other distinguishing mark may be provided in or near each tissue sample container 450, as embossed, recessed, or otherwise. In the example shown, a number of distinction marks are provided on the main portion 410 proximal to each tissue sample container 450. In another embodiment, a radiopaque marker can be provided on or near each tissue sample container 450. For example , an entire tray 400 that is carrying one or more tissue samples can be placed under X-rays for evaluation, and the radiopaque marker associated with each tissue sample container 450 (and therefore associated with a corresponding tissue sample) can be visible in the image obtained using X-rays. In other words, tissue samples may not need to be removed from trays 400 to take X-rays or X-ray images of tissue samples. In addition, trays 400 can be dropped directly into formalin or any other liquid with the tissue samples still contained in the 450 tissue sample containers. Other structures and techniques that can be used with 400 trays as will be apparent to those skilled in the art in view of the teachings of the present invention. 3. Exemplary external coverage
[00036] An outer cover 120 can also be provided with tissue sample support 100, as shown in FIG. 3. The outer cover 120 comprises a distal coupling section 122, a hollow cylindrical body 124, and a proximal ferrule extended inward 126. The proximal ferrule 126 extends radially inward to substantially limit the rotating tubing 140 to move proximally along the longitudinal geometric axis away from probe 20 when tissue sample holder 100 is coupled to probe 20. Distal coupling section 122 is configured to mate with a proximal end of probe 20. Merely exemplary coupling configurations include friction fit, tongue and groove, fasteners, clamps, screws, bolts, integral threading, or any other suitable coupling mechanism as will be apparent to a person skilled in the art in view of the teachings of the present invention. In addition, a seal 28 can be provided at the proximal end of probe 20 which can assist in sealing the outer cover 120 and / or rotating tubing 140 when coupled to the proximal end of probe 20. The seal 28 of the present example comprises a ring seal in The rubber seal, but other equally suitable seals, including disc type seals or silicone seal, can be used for seal 28. The hollow cylindrical body 124 is dimensioned in such a way that the rotating tubing 140 can rotate in the hollow cylindrical body 124 between the proximal ferrule 126 and the distal coupling section 122 while the outer cover 120 is coupled to the probe 20. The distal coupling section 122 may further comprise a tongue extending inwardly, and the rotating tubing 140 may comprise a complementary groove 134 formed in the distal flange 132 in such a way that the tongue can be inserted through the groove 134 when inserting the rotating tubing 140 in the outer cover internal 120. The distal flange 132 of the rotating tubing 140 substantially limits the rotating tubing 140 from moving distally along the longitudinal geometric axis when the tongue and groove 134 are not aligned. Therefore, it will be recognized that the distal flange 132, tongue and proximal ferrule 126 cooperatively retain rotating tubing 140 in outer shell 120 by limiting the longitudinal movement of rotating tubing 140 while still allowing rotational motion. The outer cover 120 can be made of a transparent material or a translucent material such that the rotating tubing 140 can be seen. In such a situation, the rotating tubing may have a plurality of markings on the outside of the rotating tubing to indicate that each chamber 150,160 of the rotating tubing or in an alternative, only the access chamber 160 can have a corresponding marking on the rotating tubing 140. an additional alternative, the outer cover 120 may be an opaque material.
[00037] Still in an additional version, the proximal ferrule 126 can be omitted and a pair of pressure lugs (not shown) can be formed at a proximal end of the rotating tubing 140. The pressure lugs extend radially out of the rotating tubing 140 in such a way that the external cover cannot rotate proximally beyond the pressure reliefs. Such pressure spikes can be located approximately 180 degrees apart from each other on rotating piping 140, or such pressure spikes can be at any other appropriate location on rotating piping 140, including from one degree to 180 degrees, inclusive. In addition, a single pressure boss can be provided or, in other cases, more than two pressure bosses can be provided. Of course, other configurations equally suitable for the outer cover 120 and rotating tubing 140 will be apparent to a person skilled in the art in view of the teachings of the present invention.
[00038] Although several exemplary versions for the tissue sample holder 100 have been described, still other suitable ways in which the tissue sample holder 100 can be constructed and operable will be apparent to those skilled in the art in view of the teachings of the present invention. 111. Exemplary marker applicator
[00039] As shown in FIG. 10, an exemplary marker implantation tool 600 comprises a marker cannula 610 having a distal end 612 and a lateral implant opening 620. A biopsy site marker 650 is slidably disposed on marker cannula 610. The implantation tool of marker 600 further comprises a pusher rod 630 having a distal end located proximal to the biopsy site marker 650. pusher rod 630 is also slidably arranged in the cannula of marker 610 and is operable to push the biopsy site marker 650 to through. side implant opening 620, as shown in FIG. 10. Some merely exemplary marker implantation tools include MAMMOMARK ™, MICROMARK® and CORMARK ™ branded devices from Devicor Medical Products, Inc., Cincinnati, Ohio.
[00040] A claw 640 can be attached to the marker cannula 610 and a plunger 644 can be attached to the push rod 630 in such a way that the marker implantation tool 600 can be manipulated by a single hand of a user to implant the marker biopsy site 650. For marker implantation tools 600 having a lateral implant opening 620, it may be necessary to include a ramp-like structure at or near the distal end of marker 610 cannula to reorient the biopsy site marker 650 out of the side implant opening 620. In cases where a relatively flexible marker implant tool 600 is required, marker cannula 610 and pusher 630 can be constructed of relatively flexible materials. Alternatively, marker cannula 610 and pusher rod 630 can be constructed of relatively rigid materials. In addition, marker cannula 610 and pusher rod 630 can be constructed partly from relatively flexible materials and partly from relatively rigid materials. In addition, it may be desirable for the driving rod 630 to be constructed of a relatively rigid material which can also be flexed laterally. An exemplary material may comprise a memory format material, such as nitinol. It should be understood that although the present disclosure describes the implantation of a 650 biopsy site marker, other items can be used with the 600 marker implantation tool, including, however, not limited to dyes or radioactive items, medicinal items (liquid , semi-solid or solid) and / or any other item. Various other versions and adaptations for the marker implantation tool 600 will be apparent to a person skilled in the art in view of the teachings of the present invention. A. Exemplary stepped tip
[00041] In some situations, manufacturing variations create push rods for different size marker implantation tools. On occasions where the pusher rod is slightly longer than expected, the pusher rod can be redirected through the ramp at the distal end of the cannula and protrude out of the lateral implant opening when the plunger is fully pressed in. While this may not necessarily be a problem for some users, on occasions, a user using a marker implantation tool may continue to press on the plunger while removing the marker implantation tool on the biopsy device. If the pusher rod is still extended out of the side implant opening, the side opening of the biopsy device and / or tubular cutter can separate a portion of the pusher rod when the user is removing the marker implanting tool. Therefore, it may be useful to provide a way of limiting the tendency for the pusher to project out of the lateral implant opening, thereby reducing the likelihood of separating the pusher or at least decreasing the size of any portion of the pusher that is separate.
[00042] With reference to FIGS. 10-11, a stepped tip 700700 is coupled to the distal end 612 of the cannula 610. The stepped tip 700700 may be a molded or cast component, and the stepped tip 700700 may comprise a distal tip 714, a ramp 710 having a ramp surface 712, and a marker engagement element 720. The ramp surface 712 assists in orienting the biopsy marker 650 from the inner marker cannula 610 through the side implant opening 620. The marker engagement element 720 can be optionally used to retain the biopsy marker 650 in the marker cannula 610 until the user intends to implant the biopsy marker 650. The marker engagement element 720 of the present example is arranged in the marker cannula 610 and extends over a portion of the marker cannula 610 opposite side implant opening 620 such that side engaging member 720 reinforces the portion of marker cannula 610 where the side implant opening 620 is formed. A merely exemplary benefit for such an arrangement is that the marker engaging element 720 can help to stiffen the marker cannula 610 in the region where the wall of the marker cannula 610 is cut to form lateral implant opening 620. As shown in FIG. 11, the marker engaging element 720 extends from the most proximal portion of the ramp surface 712, but does not extend proximally to the most proximal end of the lateral implant opening 620, although it should be understood that in other embodiments a portion of the marker engagement 720 can extend proximally to the side implant opening 620. The marker engagement element 720 also comprises a tapered proximal end 722 to assist in inducing the biopsy marker 650 out through the side implant opening 620. In one version merely exemplary, the marker engagement element 720 has a tapered proximal end 722 having a first incident angle of approximately 30 degrees and the ramp 710 has a second incident angle of approximately 45 degrees.
[00043] The stepped tip 700700 of the present example further comprises an impeller stem recess 730 extending proximally to the ramp surface 712. The impeller stem recess 730 is configured to be able to at least partially receive the distal end of the impeller stem 630 when plunger 644 is pressed in, although it should be understood that pusher rod 630 is not required to be insertable into pusher recess 730. In the example shown in FIG. 11, the driving rod recess 730 comprises a longitudinal hemicylindrical recess extending from the ramp 710 such that the surface of the ramp 712 comprises a U-shaped surface so that the biopsy marker 650 is deflected outwardly and inwardly the biopsy site. The longitudinal length of the impeller rod recess 730 can be determined in such a way that the variable length impeller rods 630 resulting from variations during manufacture will fit into the impeller rod recess 730. A merely exemplary longitudinal length for impeller rod recess 730 can be approximately 10.26 inches. The push rod recess 730 can also have a vertical depth between approximately 0.03 and 0.052 inches. In addition, the pusher rod 630 and the pusher stem recess 730 can be configured to have a smaller diameter than the cannula of marker 610 and marker 650 in such a way that marker 650 does not enter the pusher stem recess 730. Of course, another equally suitable design will be evident to a person skilled in the art in view of the teachings of the present invention.
[00044] In the arrangement shown in FIGS. 10-11, when the push rod 630 is driven distally by the user who presses the plunger 644, the push rod 630 slides the biopsy marker 650 distally into the marker cannula 610. When the biopsy marker 650 meets the element of coupling of marker 720, marker 650 is deflected out through the side implant opening 620. As the pusher rod 630 and marker 650 advance further distally, marker 650 is additionally guided out of the side implant opening 620 through the ramp surface 712. As the pusher rod 630 continues to advance distally to ensure that the biopsy marker 650 is implanted, the pusher rod 630 deflects slightly out of the ramp surface 712 and enters the rod recess impeller 730. When the plunger 644 is fully pressed in, the impeller rod 630 of the present example can be located at least partially in the recess of impeller rod 730, although the rod and impeller 630 may not alternatively enter the recess of impeller rod 730. Thus, even if a user continues to press the plunger 644 while removing the marker implantation tool 600, only a little, if any, of the impeller rod 630 protrudes side implant opening 620. As will be recognized by a person skilled in the art in view of the teachings of the present invention, when the user is removing the marker implantation tool 600, the pusher stem recess 730 decreases the possibility of a portion of the driving rod 630 be separated by the side opening 46 of the tubular cutter 90 of the biopsy device 10.
[00045] It should be understood, however, that the impeller rod recess 730 can be configured in other ways as well. For example, the push rod recess 730 may be a recess enclosed in the stepped tip 700700 located below the side implant opening 620 such that the push rod 630, if it enters the push rod recess 730 does not protrude out of the opening. lateral implantation 620. Pusher rod 630 enters the closed recess instead. Such a configuration for this enclosed cylindrical recess may be a hemicylindrical recess in the marker engaging element 720 and a cylindrical recess enclosed in the ramp 710. Other configurations may include several geometrically shaped recesses to accommodate a wide variety of pusher configurations. In addition, the stepped tip 700700 may comprise a radiopaque marker embedded in the stepped tip 700700 or the stepped tip 700700 may be made of a radiopaque material to assist in imaging the marker implantation tool 600 while implanting the marker 650. In addition, the stepped tip 700700 can comprise other materials suitable for viewing by other equally suitable imaging techniques. Of course, the stepped tip 700700 can be configured in any other appropriate manner as will be apparent to a person of ordinary skill in view of the teachings of the present invention. B. Exemplary alternative staggered tip
[00046] An alternative exemplary stepped tip 750 is shown in FIG. 12. The alternative stepped tip 750 can also be a cast or molded component, and the alternative stepped tip 750 of the present example comprises a distal tip 752, a ramp 760 having a ramp surface 762, and a marker engaging element 770. The ramp surface 762 assists in orienting the biopsy marker 650 from the inner marker cannula 610 through the exemplary alternative side implant opening 790. The marker engagement element 770 can be optionally employed to retain the biopsy marker 650 in the marker cannula 610 until the user intends to implant the biopsy marker 650, shown in FIG. 10. The marker engagement element 770 of the present example is arranged on the marker cannula 610 and extends over a portion of marker cannula 610 opposite side implant opening 790 in such a way that the marker engagement element 770 reinforces the portion of the marker cannula 610 where the lateral implant opening 790 is formed. A merely exemplary benefit for such an arrangement is that the marker engaging element 770 can help reinforce the marker cannula 610 in the region where the wall of the marker cannula 610 is cut to form lateral implant opening 790. As shown in FIG. 12, the marker engaging element 770 extends from the most proximal portion of the ramp surface 762, but does not extend proximally to the most proximal end of the lateral implant opening 790, although it should be understood that in other embodiments a portion of the marker engagement 770 can extend proximally to the side implant opening 790. The marker engagement element 770 also comprises a tapered proximal end 772 to assist in inducing the biopsy marker 650 out through the side implant opening 790. In one configuration merely exemplary, the marker engagement element 770 has a tapered proximal end 772 having a first incident angle of approximately 30 degrees and the ramp 760 has a second incident angle of approximately 45 degrees.
[00047] The alternative stepped tip 750 of the present example further comprises an impeller stem recess 780 extending proximally from the ramp surface 762. The impeller stem recess 780 is configured to be able to at least partially receive the distal end of the stem pusher 630 when plunger 644 is pressed in, although it should be understood that pusher rod 630 is not required to be reinsertable in pusher recess 780. In the example shown in FIG. 12, the driving rod recess 780 comprises a longitudinal hemicylindrical recess extending from the ramp 760 such that the ramp surface 762 comprises a U-shaped surface so that the biopsy marker 650 is deflected outwardly and inwardly the biopsy site. The longitudinal length of the impeller rod recess 780 can be determined in such a way that the variable length impeller rods 630 resulting from variations during manufacture will fit into the impeller rod recess 780. The recess of the impeller rod 780 of the present example further comprises a distal ramp 782. The distal ramp 782 ends at the distal end of the lateral implantation opening 790 and extends proximally into the pusher recess 780. In a merely exemplary version, the distal ramp 782 extends from the distal end of the lateral implantation opening 790 to a point approximately half the distance between the proximal end of the pusher stem recess 780 and the distal end of the lateral implant opening 790. Of course, the distal ramp 782 can extend proximally to the ramp 760 or to any other appropriate location between the ramp 760 and the distal end of the side implant opening 790. The ramp d istal 782 of the present example can further assist in the implantation of the biopsy marker 650 by reducing the likelihood that the biopsy marker 650 will catch at the distal end of the lateral implant opening 790. The impeller rod 630 and impeller rod recess 780 can also be configured to have a smaller diameter than the cannula of marker 610 and marker 650 in such a way that marker 650 does not enter the recess of pusher rod 780. Of course, another equally suitable design will be evident to a person skilled in the art in view of the teachings of the present invention.
[00048] Similar to the arrangement shown in FIGS. 10-11, when the biopsy marker 650 meets the marker engagement element 770 of the example shown in FIG. 12, the marker 650 is deflected out through the side implant opening 790. As the impeller rod 630 and marker 650 advance further distally, the marker 650 is additionally guided out of the side implant opening 790 through the surface of ramp 762. As the impeller rod 630 continues to advance distally to ensure that the biopsy marker 650 is implanted, the impeller rod 630 deflects slightly off the ramp surface 762 and enters the impeller rod 780 process. biopsy 650 may additionally deflect out of distal ramp 782. When plunger 644 is fully chocked, pusher rod 630 can be located at least partially in pusher stem recess 780, although pusher stem 630 may alternatively not enter the stem recess impeller 780. In the example shown in FIG. 12, some impeller rods 630 can deflect out of distal ramp 782. Such deflection can further assist in implanting the biopsy marker 650 out of the side marker opening 790. Similar to the marker implantation tool 600 of FIGS. 10-11, only a little, if any, of the driving rod 630 protrudes from the lateral implant opening 790 in the present example. As will be recognized by a person skilled in the art in view of the teachings of the present invention, when the user is removing the marker implantation tool 600, the push rod recess 780 decreases the possibility of a push rod portion 630 being separated by opening side 46 or tubular cutter 90 of the biopsy device 10. C. Magnetic marker implantation tool tip
[00049] Although access to the patient's tissue or a tissue cavity may be provided through an access chamber in the tissue sample holder, in some cases the lateral opening of the needle is located a long distance from the access chamber . In such cases, if a marker is to be implanted in the tissue, an elongated marker implantation tool may need to be used to reach the lateral opening. In addition, with small size needles, the marker implantation tool may also be required to be a thin shank. In certain situations where the marker implantation tool is a relatively flexible tool, aligning the end of the marker implantation tool with the access chamber can become a difficult task due to the tool's length and flexion. Therefore, it may be desirable to have some method of assisting the user in guiding the tip of the marker implantation tool to the access chamber.
[00050] An alternative marker implantation tool 800 is shown in FIG. 13. The marker implantation tool 800 comprises a marker cannula 810, a biopsy site marker 850 slidably disposed in marker cannula 810, and an impeller rod 830 having a distal end located proximal to the biopsy site marker 850. In the present example, marker cannula 810 has a distal end 812 and a lateral implant opening 820, although it should be understood that these characteristics are merely optional. For example, the marker cannula 810 can have a blind open distal end, a sharp open distal end, a valve end, or any other configuration suitable for marker cannula 610. The push rod 830 is also slidably arranged in the marker cannula. 810 and is operable to push the biopsy site marker 850 out through the side implant opening 820, as shown in FIG. 13. A handle can be attached to the marker cannula 810 and a plunger can be attached to the push rod 830 in such a way that the marker implantation tool 800 can be manipulated by a single hand of a user to implant the location marker. biopsy 850. For marker implantation tools 800 having a lateral implant opening 820, a ramp-like structure, such as the scallop tips 700, 750 described above, can be provided at or near the distal end of marker cannula 810 for reorienting the biopsy site marker 850 out of the side implant opening 820. In instances where a relatively flexible marker implantation tool 800 is required, the marker cannula 810 and pusher 830 can be constructed of relatively flexible materials. Alternatively, it may be desirable for the driving rod 830 to be constructed of a relatively rigid material which can also be flexed laterally. An exemplary material may comprise a memory format material, such as nitinol. In still other versions, the driving rod 830 may comprise a relatively rigid material while the distal portion comprises a relatively flexible material. Alternatively, the proximal portion may comprise a relatively flexible material while the distal portion comprises a relatively rigid material. Still several other versions and adaptations for marker implantation tool 800 will be evident to a person skilled in the art in view of the teachings of the present invention.
[00051] The marker implantation tool 800 of the present example further comprises a magnet 860 disposed at or near the distal end of the cannula 810. The magnet 860 can be a ferrous magnet, a neodymium magnet, a samarium-cobalt magnet, or any other suitable magnet 860 as will be apparent to a person skilled in the art in view of the teachings of the present invention. In an exemplary version, the magnet 860 is incorporated into the distal end 812. Alternatively, the magnet 860 can be adhesively attached to the distal end 812. Still in an additional version, the magnet 860 can be incorporated or adhesively attached to the marker cannula 810. The 860 magnet can also be any suitable shape, such as a sphere, cylinder, bar or any other shape. In an additional version, the magnet 860 may comprise a powder or a plurality of magnets that can be impregnated at the distal end 812. Still other configurations equally suitable for the magnet 860 and marker implantation tool 800 will be apparent to a person skilled in the art in view of the teachings of the present invention.
[00052] A magnet or complementary magnets 900 are coupled to the biopsy device 10. In a merely exemplary version shown in FIG. 14, the complementary magnets 900 can be located on the rotating tubing 140 and affixed near the access chamber 160 of the tissue sample holder 100, as described above. Specifically, a plurality of magnets 900 are affixed and arranged around the proximal opening of the access chamber 160. In a purely exemplary version, six magnets 900 can be arranged around the access chamber 160 such that the access chamber 160 be the center of the six-magnet ring 900. Alternatively, an annular magnet can be used instead of a plurality of magnets. As a person skilled in the art will recognize, the magnet ring 900 forms a magnetic field that can attract magnet 860 in the marker implantation tool 800 towards the ring. Alternatively, the marker implantation tool 800 may comprise a magnetically attractive metal element positioned at the distal end 812 of the marker implantation tool 800 such that the magnet ring 900 attracts the distal end 812. That magnetically attractive metal may comprise a powder or a plurality of metal components, such as small globes, that can be impregnated at the distal end 812. In addition, if the marker implantation tool 800 comprises a metallic marker cannula 810, then the marker cannula 810 can be attracted to 900 magnets. An additional version may include omitting 900 magnets and replacing the 900 magnets with a magnetically attractive metallic ring element in such a way that the magnet 860 of the marker implantation tool 800 can be attracted to the ring element. In the example shown in FIGS. 13-14, when a user may be trying to align the tip of the marker implantation tool 800, magnet 860 and magnets 900 cooperatively assist the user by magnetically guiding the tip of the marker implantation tool 800 toward the opening of the chamber. access 160. In this way, a user may be able to insert the marker implantation tool 800 into the opening of the access chamber 160 with one hand without having to grab or adjust the end of the marker implantation tool 800. Still other configurations equally suitable for the ring of magnets 900, magnet 860, access chamber 160 and marker implantation tool 800 will be evident to a person skilled in the art in view of the teachings of the present invention.
[00053] Although the above discussion has described the complementary magnets 900 as being implemented close to the access chamber 160 of the tissue sample holder 100, the magnets 900 can be arranged in other equally suitable areas on the biopsy device. For example, in a biopsy device having a side opening for insertion of a marker implantation tool, 900 magnets can be affixed, incorporated or coupled near or around that side opening. Similarly, for a biopsy device without a tissue sample holder nearby, magnets 900 can be attached, incorporated or attached to a tubular cutter, such as the tubular cutter 90 described above. In an alternative version, the magnet ring 900 can be located adjacent to the transfer element 22 in such a way that the marker implanting tool 800 can be attracted to the magnet ring 900 when the tissue sample holder 100 is removed. In such a version, the magnet ring 900 can be located proximally to the transfer element 22 or distally in the transfer element 22. In the version having the magnet ring 900 located distally in the transfer element 22, a funnel (not shown), can be provided to possibly assist in guiding the marker implantation tool 800. In addition, the ring of magnets 900 can be impregnated in a housing 80 portion near transfer element 22 or tubular cutter 90. Magnets 900 can be configured to any other appropriate location on a biopsy device to facilitate the orientation of the marker implantation tool 800 for use in implanting markers into a patient's body as will be apparent to a person skilled in the art in view of the teachings of the present invention .
[00054] It should be recognized that any patent, publication or other disclosure material, wholly or in part, that is said to be incorporated by reference here is incorporated only to the extent that the incorporated material does not conflict with definitions, statements or other existing disclosure material exposed in that disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein replaces any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference here, but which conflicts with definitions, statements or other existing disclosure material set forth herein will only be incorporated to the extent that no conflict originates between that material embedded and existing disclosure material.
[00055] The modalities of the present invention have application in endoscopic instruction and conventional open surgery as well as application in robotic aid surgery.
[00056] The modalities of the devices disclosed here can be designed to be eliminated after a single use, or can be designed to be used multiple times. The modalities can, in either or both cases, be reconditioned for reuse after at least one use. Reconditioning can include any combination of steps to disassemble the device, followed by cleaning or replacing specific parts, and subsequent reassembly. In particular, the arrangements of the device can be disassembled, and any number of specific parts or parts of the device can be selectively replaced or removed in any combination. After cleaning and / or replacing specific parts, the device's modalities can be reassembled for subsequent use in a reconditioning facility, or by a surgical team immediately before a surgical procedure. Those skilled in the art will recognize that the reconditioning of a device can use a variety of techniques for disassembly, cleaning / replacement and reassembly. The use of such techniques and the resulting reconditioned device are all within the scope of this application.
[00057] Just as an example, the modalities described here can be processed before surgery. First, a new or used instrument can be obtained and cleaned if necessary. The instrument can then be sterilized. In a sterilization technique, the instrument is placed in a closed and sealed container, such as a TYVEK or plastic bag. The container and instrument can then be placed in a radiation field that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. Radiation can kill bacteria on the instrument and the container. The sterile instrument can then be stored in the sterile container. The sealed container can keep the instrument sterile until it is opened in a medical facility. A device can also be sterilized using any other technique known in the art, including, but not limited to beta or gamma radiation, ethylene oxide or steam.
[00058] Having shown and described various embodiments of the present invention, further adaptations of the methods and systems described here can be made by appropriate modifications by a person skilled in the art without departing from the scope of the present invention. Several of these potential modifications have been mentioned, and others will be evident to those skilled in the art. For example, the examples, modalities, geometric, materials, dimensions, reasons, steps and the like discussed above are illustrated and are not required. Therefore, the scope of the present invention should be considered in terms of the following claims and is understood to be not limited to the details of the structure and operation shown and described in the specification and drawings.
权利要求:
Claims (27)
[0001]
1. Marker implantation tool (600, 800) characterized by the fact that it comprises: (a) a marker cannula (610, 810) comprising: (i) a distal end; (ii) a proximal end; and (iii) a lateral implantation opening (620, 790); wherein the lateral implant opening (620, 790) is spaced proximal to the closed distal end, and where the lateral implant opening (620, 790) is configured to substantially align with a lateral opening of a biopsy device; (b) an impeller rod (630) having a distal end, wherein the impeller rod (630) is slidably disposed within the marker cannula (610, 810); and (c) a stepped tip (700, 750) having a longitudinal geometric axis, the stepped tip (700, 750) comprising: (i) a distal tip (714); (ii) a ramp (710, 760) having a ramp surface (712, 762), wherein the ramp (710, 760) is spaced proximal to the distal tip (714); and (iii) a pusher recess (730, 780) extending distally from the ramp surface (712, 762) along the longitudinal geometric axis; where the impeller rod recess (730, 780) is sized to receive a portion of the distal end of the impeller rod (630) and where the stepped tip (700, 750) is coupled to the distal end of the marker cannula (610, 810); where the marker implantation tool (600, 800) is operable to implant a biopsy site marker into a biopsy site.
[0002]
2. Marker implantation tool (600, 800), according to claim 1, characterized by the fact that the stepped tip (700, 750) comprises a marker engagement element.
[0003]
3. Marker implantation tool (600, 800), according to claim 2, characterized by the fact that the marker hitch element extends proximally from the ramp (710, 760).
[0004]
4. Marker implantation tool (600, 800) according to claim 2, characterized in that the marker engaging element comprises a tapered proximal end.
[0005]
5. Marker implantation tool (600, 800), according to claim 4, characterized by the fact that the tapered proximal end has a first incident angle and the ramp (710, 760) has a second incident angle, in which the first incident angle is less than the second incident angle.
[0006]
6. Marker implantation tool (600, 800), according to claim 1, characterized by the fact that the impeller rod recess (730, 780) comprises a hemicylindrical recess.
[0007]
7. Marker implantation tool (600, 800), according to claim 1, characterized by the fact that the impeller stem recess (730, 780) comprises a distal ramp.
[0008]
8. Marker implantation tool (600, 800) according to claim 1, characterized by the fact that the impeller rod (630) comprises a proximal portion and a distal portion, wherein the proximal portion comprises a relatively rigid material and the distal portion comprises a relatively flexible material.
[0009]
9. Marker implantation tool (600, 800), according to claim 1, characterized by the fact that it comprises a biopsy site marker slidably disposed within the marker cannula (610, 810).
[0010]
10. Marker implantation tool (600, 800), according to claim 9, characterized by the fact that the ramp (710, 760) is configured to redirect the biopsy site marker out of the lateral implantation opening ( 620, 790) when the biopsy site marker is triggered by the impeller rod (630).
[0011]
11. Marker implantation tool (600, 800), according to claim 1, characterized by the fact that the distal tip (714) of the stepped tip (700, 750) comprises a magnet.
[0012]
12. Marker implantation tool (600, 800), according to claim 1, characterized by the fact that the impeller rod recess (730, 780) comprises a closed cylindrical recess.
[0013]
13. Marker implantation tool (600, 800), according to claim 1, characterized by the fact that the stepped tip (700, 750) comprises a radiopaque material.
[0014]
14. Marker implantation tool (600, 800), according to claim 1, characterized by the fact that the impeller rod (630) comprises nitinol.
[0015]
15. System characterized by the fact that it comprises: (a) a biopsy device comprising: (i) a holster; (ii) a probe coupled to the holster, in which the probe comprises a needle extending proximally from the probe, in which the needle comprises a distal tip (714) and a spaced lateral opening proximal to the distal tip (714); and (iii) a tissue sample holder comprising a plurality of chambers, wherein at least one of the plurality of chambers is an access chamber, wherein the access chamber extends longitudinally through the tissue sample holder, wherein the tissue sample holder is coupled to the probe and operable to rotate to selectively align one of the plurality of chambers with the needle; wherein the access chamber is configured to allow selective access to the needle through the tissue sample holder for a marker implanting tool (600, 800) when the access chamber is longitudinally aligned with the needle; and (b) a marker implantation tool (600, 800) comprising: (i) a marker cannula (610, 810); (ii) an impeller rod (630); and (iii) a distal tip (714).
[0016]
16. System according to claim 15, characterized by the fact that the tissue sample holder comprises a magnet.
[0017]
17. The system according to claim 16, characterized by the fact that the magnet comprises a plurality of magnets arranged around the access chamber.
[0018]
18. System according to claim 15, characterized by the fact that the marker implantation tool (600, 800) comprises a magnet.
[0019]
19. System according to claim 15, characterized by the fact that it comprises a removable plug configured to be insertable in the access chamber, in which the removable plug substantially seals the access chamber when inserted therein.
[0020]
20. System according to claim 15, characterized in that the tissue sample holder comprises a seal within the access chamber and located substantially at a longitudinal midpoint of the access chamber.
[0021]
21. System according to claim 15, characterized by the fact that the tissue sample holder comprises an internal seal, in which the internal seal comprises a recessed distal face, in which the internal seal is located substantially at a distal end access chamber.
[0022]
22. System according to claim 21, characterized in that the tissue sample holder comprises an external seal located substantially at a proximal end of the access chamber.
[0023]
23. Marker distribution device characterized by the fact that it comprises: (a) a tube having a lateral marker implant opening; (b) at least one biopsy marker disposed proximally to the lateral marker implant opening within the tube; (c) an element having a distal end and disposed at least partially within the tube, the element movable in a distal direction to implant at least one biopsy marker of the tube through the lateral implantation opening (620, 790); and (d) a distal tip (714), wherein the distal tip (714) comprises a recess and a ramp (710, 760) configured to deflect at least one biopsy marker, wherein the recess is sized and shaped to receiving a portion of the distal end of the element, the recess defining an opening in at least a portion of the ramp (710, 760).
[0024]
24. Marker dispensing device according to claim 23, characterized in that the recess is sized and shaped to prevent the at least one biopsy marker from substantially entering the recess.
[0025]
25. Marker distribution device according to claim 23, characterized in that the recess extends distally from the ramp surface (712, 762).
[0026]
26. Marker dispensing device according to claim 23, characterized in that the distal tip (714) is insertable at a distal end of the tube.
[0027]
27. Marker dispensing device according to claim 23, characterized in that the distal tip (714) is securely attached to a distal end of the tube.
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同族专利:
公开号 | 公开日
JP6242791B2|2017-12-06|
CA2844622A1|2013-02-14|
EP2741677A2|2014-06-18|
AU2012294829B2|2016-07-07|
HK1198802A1|2015-06-12|
CA2844622C|2020-01-07|
US20160296214A1|2016-10-13|
KR20140044893A|2014-04-15|
PL2741677T3|2018-11-30|
AU2012294829A2|2014-02-20|
CN104039238A|2014-09-10|
BR112014002715A8|2017-06-20|
US20150157417A1|2015-06-11|
EP2741677A4|2015-05-13|
US20160302779A1|2016-10-20|
US20130041256A1|2013-02-14|
US9717482B2|2017-08-01|
US9717483B2|2017-08-01|
US9370402B2|2016-06-21|
US9737285B2|2017-08-22|
US8938285B2|2015-01-20|
KR101858460B1|2018-05-16|
AU2012294829A1|2014-02-06|
WO2013022614A2|2013-02-14|
CN104039238B|2017-03-29|
EP2741677B1|2018-06-06|
JP2014525278A|2014-09-29|
US20160287222A1|2016-10-06|
BR112014002715A2|2017-06-13|
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法律状态:
2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
2019-10-29| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
2020-09-01| B09A| Decision: intention to grant|
2020-12-08| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/07/2012, OBSERVADAS AS CONDICOES LEGAIS. |
优先权:
申请号 | 申请日 | 专利标题
US13/205,189|2011-08-08|
US13/205,189|US8938285B2|2011-08-08|2011-08-08|Access chamber and markers for biopsy device|
PCT/US2012/048534|WO2013022614A2|2011-08-08|2012-07-27|Access chamber and markers for biopsy device|
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