HK1232757B - Introducer for biopsy device - Google Patents

Description

Introducer for biopsy device

Background Art

Biopsy samples are obtained in a variety of ways using a variety of devices during various medical procedures. The biopsy devices can be used under simple visual guidance, eyelid guidance, stereotactic guidance, ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or by other means. For example, some biopsy devices can be fully operated by the user using a single hand and with a single insertion to obtain one or more biopsy samples from a patient. In addition, some biopsy devices can be fastened to a vacuum module and/or a control module, such as for communication of fluids (e.g., pressurized air, saline, atmospheric air, vacuum, etc.), for power communication, and/or for command communication, etc. Other biopsy devices can be fully or at least partially operated without being fastened or otherwise connected to another device.

Merely exemplary biopsy devices are disclosed in the following documents: U.S. Patent No. 5,526,822, entitled “Method and Apparatus for Automated Biopsy and Collection of Soft Tissue,” issued on June 18, 1996; U.S. Patent No. 6,086,544, entitled “Control Apparatus for an Automated Surgical Biopsy Device,” issued on July 11, 2000; U.S. Publication No. 2003/0109803, entitled “MRI Compatible Surgical Biopsy Device,” issued on June 12, 2003; U.S. Patent No. 7,507,210, entitled “Biopsy Cannula Adjustable Depth Stop,” issued on March 24, 2009; and U.S. Patent No. 1,896,979, entitled “Biopsy Apparatus and U.S. Publication No. 2006/0074345, entitled “Remote Thumbwheel for a Surgical Biopsy Device,” published on May 24, 2007; U.S. Publication No. 2007/0118048, entitled “Presentation of Biopsy Sample by Biopsy Device,” published on September 4, 2008; U.S. Publication No. 2009/0171242, entitled “Clutch and Valving System for Tetherless Biopsy Device,” published on July 2, 2009; U.S. Publication No. 2010/0152610, entitled “Hand Actuated Tetherless Biopsy Device with Pistol Grip,” published on June 17, 2010; and U.S. Publication No. 2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device,” published on September 4, 2008. and U.S. Patent No. 8,764,680, issued on July 1, 2014, entitled “Handheld Biopsy Device with Needle Firing.” The disclosures of each of the above-cited U.S. patents, U.S. patent application publications, and U.S. non-provisional patent applications are hereby incorporated by reference.

In some settings, it may be desirable to mark the location of the biopsy site for future reference. For example, one or more markers may be placed at the biopsy site before, during, or after a tissue sample is obtained from the biopsy site. Exemplary marker deployment tools include the and trademark devices from Devicor Medical Products, Inc. of Cincinnati, Ohio. Further exemplary devices and methods for marking a biopsy site are disclosed in the following: U.S. Publication No. 2009/0209854, entitled “Biopsy Method,” published on August 20, 2009; U.S. Publication No. 2009/0270725, entitled “Devices Useful in Imaging,” published on October 29, 2009; U.S. Publication No. 2010/0049084, entitled “Biopsy Marker Delivery Device,” published on February 25, 2010; U.S. Publication No. 2011/0071423, entitled “Flexible Biopsy Marker Delivery Device,” published on March 24, 2011; U.S. Publication No. 2011/0071424, entitled “Biopsy Marker Delivery Device,” published on March 24, 2011; and U.S. Publication No. 2011/0071425, entitled “Biopsy Marker Delivery Device,” published on March 24, 2011. U.S. Patent Publication No. 2011/0071391, entitled “Delivery Device with Positioning Component”; U.S. Patent No. 6,228,055, entitled “Devices for Marking and Defining Particular Locations in Body Tissue”, issued on May 8, 2001; U.S. Patent No. 6,371,904, entitled “Subcutaneous Cavity Marking Device and Method”, issued on April 16, 2002; U.S. Patent No. 6,993,375, entitled “Tissue Site Markers for In Vivo Imaging”, issued on January 31, 2006; U.S. Patent No. 6,996,433, entitled “Imageable Biopsy Site Marker”, issued on February 7, 2006; and U.S. Patent No. 6,996,433, entitled “Devices for Defining and No. 7,044,957, entitled “Marking Tissue”; U.S. Patent No. 7,047,063, entitled “Tissue Site Markers for In Vivo Imaging”, issued on May 16, 2006; U.S. Patent No. 7,229,417, entitled “Methods for Marking a Biopsy Site”, issued on June 12, 2007; and U.S. Patent No. 7,465,279, entitled “Marker Device and Method of Deploying a Cavity Marker Using a Surgical Biopsy Device”, issued on December 16, 2008. The disclosure of each of the above-cited U.S. patents and U.S. patent application publications is incorporated herein by reference.

While various systems and methods have been made and used to obtain biopsy samples, it is believed that no one has made or used the invention described in the appended claims before the inventors.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims that particularly point out and distinctly claim the invention, it is believed the invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings in which like numerals refer to like elements. In the drawings, some components or portions of components are shown with broken lines.

FIG1A depicts a perspective view of an exemplary biopsy device and an exemplary introducer cannula, with the introducer cannula separated from the biopsy device;

FIG1B depicts a perspective view of the biopsy device and introducer cannula of FIG1A with the needle of the biopsy device inserted into the introducer cannula;

FIG2A depicts a partial side cross-sectional view of the introducer sheath of FIG1A ;

FIG2B depicts a partial side cross-sectional view of the needle and introducer cannula of the biopsy device of FIG1A , with the needle of the biopsy device inserted into the introducer cannula;

FIG3 depicts a front cross-sectional view of the needle of the biopsy device of FIG1A ;

FIG4 depicts a partially exploded view of the needle of the biopsy device of FIG1A ;

FIG5 depicts a partial perspective view of the proximal portion of the introducer cannula of FIG1A;

FIG6 depicts a side cross-sectional view of a proximal portion of the introducer cannula of FIG5 ;

FIG7A depicts a side cross-sectional view of the needle of the biopsy device of FIG1A partially inserted into the introducer of FIG5;

FIG7B depicts a side cross-sectional view of the needle of the biopsy device of FIG1A partially inserted into the introducer of FIG5;

FIG8 depicts a perspective view of the distal end of the introducer of FIG1A with the needle of the biopsy device of FIG1A fully inserted into the introducer;

FIG9 depicts a front cross-sectional view of the introducer and needle of FIG8 , wherein the cross-section is taken along line 9 - 9 of FIG8 ;

FIG10 depicts a partial perspective view of the distal end of the introducer of FIG1A;

FIG11 depicts a side view of the needle of the biopsy device of FIG1A fully inserted into the introducer of FIG5;

FIG12 depicts a side view of the needle of the biopsy device of FIG1A inserted into the introducer of FIG5 in an intermediate insertion state;

FIG13 depicts a side view of the needle of the biopsy device of FIG1A partially inserted into the introducer of FIG5;

FIG14 depicts a partial top view of the needle of the biopsy device of FIG1A fully inserted into the introducer of FIG5;

FIG15 depicts a partial top view of the needle of the biopsy device of FIG1A partially inserted into the introducer of FIG5;

FIG16 depicts a perspective view of an exemplary alternative introducer with the needle of the biopsy device of FIG1A fully inserted into the introducer;

FIG17 depicts a perspective view of the distal end of the introducer of FIG16;

FIG18 depicts a side view of the needle of the biopsy device of FIG1A fully inserted into the introducer of FIG16;

FIG19 depicts a side view of the needle of the biopsy device of FIG1A inserted into the introducer of FIG16 in an intermediate insertion state;

FIG20 depicts a side view of the needle of the biopsy device of FIG1A partially inserted into the introducer of FIG16;

FIG21 depicts a top view of the needle of the biopsy device of FIG1A fully inserted into the introducer of FIG16;

FIG22 depicts a top view of the needle of the biopsy device of FIG1A partially inserted into the introducer of FIG16; and

23 depicts a perspective view of an alternative configuration of the introducer of FIG. 1A with an obturator inserted into the introducer.

The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the present invention may be carried out in various other ways, including those not necessarily depicted in the drawings. The accompanying drawings, which are incorporated in and form a part of the specification, illustrate several aspects of the present invention and serve to explain the principles of the invention together with the detailed description; it should be understood, however, that the invention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the present invention should not be construed to limit the scope of the present invention. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which, by way of illustration, is intended to be one of the best modes for carrying out the present invention. It will be appreciated that the present invention is capable of various and distinct aspects without departing from the present invention. Accordingly, the drawings and description should be construed as illustrative in nature and not restrictive.

I. Overview of Exemplary Biopsy Devices

1A and 1B illustrate an exemplary biopsy device 10. Biopsy device 10 in this example includes a probe 30 and a holster 20. A needle 50 extends distally from probe 30 and is inserted into patient tissue to obtain tissue samples, as described in greater detail below. These tissue samples are placed within a tissue sample holder 40 at the proximal end of probe 30, also described in greater detail below. Probe 30 in this example is removably coupled to holster 20. It should be understood that the use of the term "holster" herein should not be construed as requiring any portion of probe 30 to be inserted into any portion of holster 20. Various types of structures, components, features, etc. (e.g., snap-fit mounts, latches, clamps, clips, snap-fit fittings, etc.) may be used to provide for removable coupling of probe 30 and holster 20. Additionally, in some biopsy devices 10, probe 30 and holster 20 may be of unitary or integral construction, such that the two components cannot be separated. By way of example only, in a form in which probe 30 and holster 20 are provided as separable components, probe 30 can be provided as a disposable component, while holster 20 can be provided as a reusable component. Still other suitable structural and functional relationships between probe 30 and holster 20 will be apparent to those of ordinary skill in the art in view of the teachings herein.

The needle 50 of the present example includes a cannula 52, a piercing tip 54, a lateral orifice 56 positioned adjacent the tip 54, and a hub member 80. The tissue piercing tip 54 is configured to pierce and penetrate tissue without requiring a significant amount of force and without requiring an opening to be preformed in the tissue prior to insertion of the tip 54. Alternatively, the tip 54 can be blunt (e.g., rounded, flat, etc.), if desired. The tip 54 can also be configured to provide greater echogenicity than other portions of the needle 50, providing enhanced visibility of the tip 54 during ultrasound imaging. By way of example only, the tip 54 can be constructed according to the teachings of U.S. Patent Publication No. 2012/0059247, entitled "Echogenic Needle for Biopsy Device," published on March 8, 2012, the disclosure of which is incorporated herein by reference in its entirety. One of ordinary skill in the art will appreciate other suitable configurations for the tip 54 in light of the teachings herein.

Lateral opening 56 is sized to receive prolapsed tissue during operation of biopsy device 10. A hollow tubular cutter 70 having a sharp distal edge (not shown) is positioned within first lumen 60 of needle 50 (as shown in FIG3 ). Cutter 70 is operable to rotate and translate relative to needle 50 and pass through lateral opening 56 to sever a tissue sample from tissue extending through lateral opening 56. For example, cutter 70 can be moved from an extended position ( FIGS. 1A-1B ) to a retracted position, in which the distal end of the cutter is positioned just proximal to the proximal end of lateral opening 56 ( FIG. 2B ), thereby "opening" lateral opening 56 to allow tissue to extend therethrough; and then from the retracted position back to the extended position to sever the protruding tissue. Mechanical components within holster 20 and probe 30 can cooperate to provide such actuation of cutter 70, as described in any of the references cited herein or otherwise. As just another illustrative example, in addition to or in lieu of being actuated by mechanical components, cutter 70 may be pneumatically actuated. Other suitable alternative forms, features, components, configurations, and functions for providing cutter actuation will be apparent to those of ordinary skill in the art in light of the teachings herein.

Although the lateral orifice 56 is shown in FIG1A as being oriented in an upward position, it should be understood that the needle 50 can be manually rotated to orient the lateral orifice 56 at any desired angular position about the longitudinal axis of the needle 50. Such rotation of the needle 50 is assisted in the present example by a hub member 80. The hub member 80 can be constructed and operated in accordance with the teachings of U.S. Patent No. 8,764,680 and/or in any other suitable manner. A person of ordinary skill in the art will appreciate in view of the teachings herein that a variety of other suitable ways of providing manual rotation of the needle 50 can be provided. It should also be understood that the rotation of the needle 50 can be automated in a variety of ways, including but not limited to the various forms of automated or motorized needle rotation described in the various references cited herein.

As best seen in FIG2B , needle 50 also includes a longitudinal wall 64 extending proximally from a proximal portion of tip 54. While wall 64 does not extend along the entire length of needle 50 in this example, it should be understood that wall 64 could extend the entire length of needle 50 if desired. Wall 64 defines a second lumen 62 that is transverse to and parallel to cutter 70. Wall 64 includes a plurality of openings 66 that provide fluid communication between second lumen 62 and first lumen 60, as well as between second lumen 62 and a lumen (not shown) of cutter 70. For example, second lumen 62 can selectively provide atmospheric air to vent the lumen of cutter 70 during operation of biopsy device 10. Openings 66 are configured such that at least one opening 68 is located at a longitudinal position distal to the distal edge of lateral aperture 56. Thus, the lumen of cutter 70 and second lumen 62 remain in fluid communication even when cutter 70 is advanced to a position where the distal cutting edge of cutter 70 is located at a longitudinal position distal to the longitudinal position of the distal edge of lateral opening 56. Of course, any other suitable configuration may be used as with any of the other components described herein.

FIG3 shows a cross-sectional view of needle 50 taken at line 3-3 of FIG2B . As can be seen, needle 50 has a non-circular cross-sectional shape, such as a generally oval shape defined by cannula 52. In the present example, longitudinal wall 64 is formed by inner tube 58, which also forms lateral aperture 56. As can be best seen in FIG4 , tube 58 is inserted into cutout portion 53 within cannula 52. Tube 58 can be secured to cannula 52 by any suitable means, such as laser welding, adhesive bonding, etc.

The probe 30 may also include a valve assembly in fluid communication with at least a portion of the needle 50 that selectively changes the pneumatic state of at least a portion of the needle 50 based on any suitable condition, such as the longitudinal position of the cutter 70. For example, such a valve assembly can selectively change the pneumatic state of the second lumen 62. Such a valve assembly can be constructed according to the teachings of U.S. Publication No. 2010/0317997, the teachings of U.S. Patent No. 8,764,680, and/or by other means. Additionally or alternatively, the valve configuration can be provided by a vacuum source and/or vacuum tank, such as taught in U.S. Patent No. 2008/0214955. Other suitable alternative forms, features, components, configurations, and functions of the needle 50 will be apparent to those of ordinary skill in the art in view of the teachings herein.

The tissue sample holder (40) of this example is configured to receive a tissue sample severed by cutter (70) and communicated proximally through the hollow interior of cutter (70). Tissue sample holder (40) may include one or more removable trays (not shown) that allow a user to remove severed tissue samples from tissue sample holder (40) without having to remove tissue sample holder (40) from probe (30). In some of these embodiments, tissue sample holder (40) is constructed in accordance with the teachings of U.S. Patent Publication No. 2012/0065542, filed on March 15, 2012, entitled "Biopsy Device Tissue Sample Holder with Removable Tray," the disclosure of which is incorporated herein by reference. Additionally or alternatively, tissue sample holder (130) may include a rotatable manifold (not shown) that is in fluid communication with the vacuum source and cutter (70) and is rotatable to sequentially index the individual tissue-receiving chambers relative to cutter (70). By way of example only, tissue sample holder (40) may be constructed and operated in accordance with the teachings of U.S. Publication No. 2008/0214955, the disclosure of which is incorporated herein by reference. As another merely illustrative example, tissue sample holder (40) may be constructed and operated in accordance with the teachings of U.S. Publication No. 2010/0160824, entitled “Biopsy Device with Discrete Tissue Chambers,” published on June 24, 2010, the disclosure of which is incorporated herein by reference. Any other suitable manner in which tissue sample holder (40) may be constructed and operated will be apparent to one of ordinary skill in the art in view of the teachings herein.

Biopsy device 10 may also include a vacuum source (not shown), such as a vacuum pump. By way of example only, the vacuum source may be incorporated into probe 30, incorporated into holster 20, and/or may be a separate component. In versions where the vacuum source is separate from probe 30 and holster 20, the vacuum source may be coupled to probe 30 and/or holster 20 via one or more conduits, such as flexible tubing. It should also be understood that the vacuum source may be in fluid communication with tissue sample holder 40 and needle 50. Thus, the vacuum source may be activated to draw tissue into lateral orifice 56 of needle 50. Tissue sample holder 40 is also in fluid communication with cutter 70 in this example. The vacuum source may also be activated to draw a severed tissue sample through the hollow interior of cutter 70 and into tissue sample holder 40. In some versions, the vacuum source is configured in accordance with the teachings of U.S. Publication No. 2008/0214955. Additionally or alternatively, the vacuum source may be configured in accordance with the teachings of U.S. Patent No. 8,764,680. As just another illustrative example, a vacuum source can be provided in accordance with the teachings of U.S. Patent No. 8,376,957, issued on February 19, 2013, entitled "Biopsy Device with Auxiliary Vacuum Source," the disclosure of which is incorporated herein by reference. Those of ordinary skill in the art will appreciate other suitable ways to provide a vacuum source in light of the teachings herein. It should also be understood that the vacuum source can simply be omitted, if desired.

The biopsy device 10 of this example is sized and configured so that it can be operated by a user with a single hand. In particular, the user can grasp the biopsy device 10, insert the needle 50 into the patient's breast, and collect one or more tissue samples from the patient's breast, all using only one hand. Alternatively, the user can grasp the biopsy device 10 with more than one hand and/or with any desired aid. It should also be understood that the biopsy device 10 can be configured to be mounted on a tabletop or fixed device and can be used under stereotactic guidance. Of course, the biopsy device 10 can alternatively be used under ultrasound guidance, MRI guidance, PEM guidance, BSGI guidance, or other methods. In some configurations, the user can obtain multiple tissue samples with a single insertion of the needle 50 into the patient's breast. Such tissue samples can be pneumatically placed into the tissue sample holder 40 and subsequently removed from the tissue sample holder 40 for analysis. Although the examples described herein generally refer to obtaining a biopsy sample from a patient's breast, it should be understood that biopsy device 10 may be used in a variety of other procedures for a variety of other purposes and within a variety of other portions of a patient's anatomy (e.g., prostate, thyroid, etc.). Other suitable components, features, configurations, and operational capabilities for biopsy device 10 will be apparent to those of ordinary skill in the art in view of the teachings herein.

II. Exemplary Introducer Sheath with Open Distal End

In some embodiments, the present invention provides a method for inserting a needle 50 into the patient's tissue. In some embodiments, the needle 50 is inserted directly into the patient's tissue so that the outer surface of the entire insertion length of the sleeve 52 directly contacts the patient's tissue. In some other forms, an introducer sleeve is used. Only by way of example, the introducer sleeve with an open distal end can first be inserted into the patient's tissue. In some cases, as described in more detail below, an obturator with a sharp distal end (extending from the open distal end of the introducer sleeve) can be placed in the introducer sleeve (when both insert the patient's tissue). If an obturator is used during the insertion of the patient's tissue, the obturator can be removed after the introducer sleeve reaches the desired depth in the tissue. Needle 50 and/or other instruments can then be fed into the introducer sleeve to arrive at the tissue at the sleeve distal end.

In some settings, such as those in which the needle of a biopsy device has a sharp end, an introducer may be coupled to the needle (before both are inserted together into the patient's tissue). Such examples are shown in Figures 1A-2B as illustrative examples only. In particular, Figure 1A shows a biopsy device 10 and an exemplary introducer 100 before the needle 50 of the biopsy device 10 is inserted into the introducer 100. Figure 1B shows the needle 50 inserted into the introducer 100. As shown in Figures 1A-1B, the introducer 100 of this example includes a cannula 102, four distal blades 104 located at an open distal end 106, and a latch feature 180. The latch feature 180 is operable to selectively secure the introducer 100 to the biopsy device 10, as described in more detail below. As shown in Figure 2A, the cannula 102 defines an inner cavity 112 that is in fluid communication with the open distal end 106. As also shown in FIG. 2A , the blades 104 are resiliently biased to deflect slightly inwardly, however gaps 110 are defined between the blades 104 to facilitate independent movement of the blades 104 toward or away from each other.

As shown in Figures 1B and 2B, when the cannula 52 of the needle 50 is fully inserted into the lumen 112 of the cannula 102, the distal portion of the needle 50 extends distally from the cannula 102. In particular, the lateral lumen 56 is fully exposed and is located distal to the open distal end 106 of the cannula 102. As described in more detail below, when the blades are in the relaxed state, the outer diameter of the cannula 52 is greater than the inner diameter defined between the blades 104. As a result, when the cannula 52 is inserted into the cannula 102, the cannula 52 deflects the blades 104 outward. In particular, the blades 104 are deflected so that they are generally aligned with the proximal portion of the sidewall of the cannula 102. The blades 104 thus resiliently abut against the cannula 52 of the needle 50.

In exemplary use, the introducer 100 is coupled to the needle 50 as shown in Figures 1B and 2B. With the cutter 70 at the distal position effectively closing the lateral orifice 56, the introducer 100 and needle 60 are then inserted together into the patient's tissue. The tip 54 punctures and penetrates the patient's tissue during this insertion. The cutter 70 then reciprocates to obtain one or more tissue samples that are placed into the tissue sample holder 40 (e.g., using vacuum assistance, etc.). Once the desired number of tissue samples has been obtained, the needle 50 is disconnected from the introducer 100 and the cannula 52 is retracted from the cannula 102 so that the cannula 102 is placed into the patient's tissue. A marker applicator (not shown) can then be inserted into the lumen 112 of the cannula 102 to place one or more markers at the biopsy site. Additionally or alternatively, one or more pharmaceutical agents, short-distance therapeutic tablets, and/or other substances can be applied to the biopsy site through the lumen 112 of the cannula 102. Additionally or alternatively, a variety of other instruments can be inserted through the lumen 112 of the cannula 102 to reach the biopsy site. The introducer 100 can then be pulled out of the patient's tissue. Still other suitable ways in which the introducer 100 may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.

The introducer 100 of this example is operable to selectively couple with the biopsy device 10 via a latch feature 180. As shown in Figures 5-7B, the latch feature 180 of this example includes a pair of latches 182 and associated buttons 184. The latches 182 are received in complementary slots 82 of the hub member 80 (as shown in Figure 1A). The latches 182 include outward projections 186 that retain the latches 182 within the hub member 80. The latches 182 and button 184 are positioned on springs 188, which resiliently bias the latches 182 to the position shown in Figure 6, thereby allowing the latches 182 to deflect downward to accommodate insertion into the slot 82 of the hub member 180. The spring 188 also allows the button 184 to be pressed downward to disengage the latches 182 from the slot 82. As also shown in Figures 5-7B, the interior of the latch feature 180 includes a ramp 190 that helps guide the distal end of the cannula 52 into the lumen 112 of the introducer 100. Although not shown, it should be understood that the introducer 100 may include one or more internal valves or seals, such as to reduce or prevent leakage of bodily fluids from the introducer 100, particularly when the needle 50 is removed from the introducer 100 while the introducer 100 remains inserted into tissue. It should also be understood that the introducer 100 can be selectively coupled to the biopsy device 10 in a variety of other ways. Other suitable variations of the latch feature 180 will be apparent to those of ordinary skill in the art in light of the teachings herein. In addition, the introducer 100 does not necessarily need to be fixed to the biopsy device 10, and the latch feature 180 and its variations can simply be omitted if desired.

FIG8 shows a detailed view of the distal end of the introducer 100 with the needle 50 fully inserted into the introducer 100. In particular, the blades 104 are shown engaging the sides of the needle 50. As described above, the needle 50 of this example has a non-circular, oval cross-section with relatively flat sides. Thus, each blade 104 can engage a portion of the relatively flat surface of the needle 50, such as by a slight interference fit. However, the gap 110 allows the blades to avoid contacting the seam between the tube 58 and the cannula 52 of the needle 50. In some examples, the interference between the needle 50 and the blades 104 can be 0.011 inches, although the interference can range from 0.005 inches to 0.02 inches. Of course, one of ordinary skill in the art will appreciate that any other suitable amount of interference can be used in view of the teachings herein.

As shown in Figures 8 and 9, the area of the introducer cannula 102 adjacent to the blades 104 can have a cross-sectional shape that corresponds to the cross-sectional shape of the needle 50. In addition, the area of the introducer cannula 102 adjacent to the blades 104 can be configured to form a slight gap or gap opening 114 between the cannula 102 and the cannula 52 of the needle 50 at the top and bottom of the needle 50. As best shown in Figure 9, the openings 114 are arranged at the top and bottom of the introducer 100 and are defined by the introducer 100 and the needle 50. The openings 114 provide clearance space to allow the introducer cannula 102 to exit the tip 54, particularly in cases where the tip 54 is slightly oversized relative to the major outer diameter of the needle cannula 52, or where a portion of the tip extends slightly above the top surface of the cannula 52 and/or a portion of the tip extends slightly below the bottom surface of the cannula 52. For example, in some instances, the needle 50 has an oversized tissue piercing tip 54. Alternatively, the tip 54 is offset to extend above or below the cannula 52. Thus, opening 114 is configured to accommodate these examples while also maintaining a relatively tight fit between introducer 100 and needle 50. Of course, in other examples, opening 114 may be omitted entirely.

FIG10 shows a detailed view of the distal end of the introducer 100 without the needle 50. As shown, in the example shown, the four blades 104 are arranged in a symmetrical configuration, with two blades 104A, 104B associated with the top of the cannula 102 and two blades 104C, 104D associated with the bottom of the cannula 102. The blades 104A, 104D are associated with one side of the cannula 102, and the blades 104B, 104C are associated with the other side of the cannula 102. In the embodiment shown, the needle 50 can be inserted into the introducer 100 in the orientation shown or in an inverted orientation.

A chamfered surface 116 can be provided in relation to the top of the cannula 102, and a chamfered surface 116 can be provided in relation to the bottom surface of the cannula 102. In the illustrated embodiment, the chamfered surface 116 is provided in relation to the upper edge portions of the blades 104A, 104B and the distal portion of the top of the cannula 102. The chamfered surface 116 can be formed by electrical discharge machining (EDM), grinding, or other suitable machining methods. The chamfered surface 116 shown in FIG. 10 includes a portion 116A associated with the upper edge portions of the blades 104A, 104B, and a tip portion 116B associated with the top of the cannula 102, which extends partially into the top surface of the cannula 102. The tip portion 116B extends between and joins the chamfered surface portions 116A formed on the blades 104A, 104B. Similarly, a second chamfered surface 116 can be provided in relation to the bottom edge portions of the blades 104A, 104B and the distal portion of the bottom of the cannula 102. This configuration allows the introducer 100 to penetrate tissue more easily, thereby reducing the penetration force required when the user inserts the biopsy device 10 into the patient. In other forms, those of ordinary skill in the art will appreciate in light of the teachings herein that the size, angle, and/or shape of the beveled surface 116 may be varied. Of course, in other examples, this feature may be omitted entirely.

The blades 104 are also shown as being resiliently biased inward. Thus, the distal ends of the blades 104 define an orifice having a geometry slightly smaller than the outer geometry of the needle 50, such as to provide a slight interference fit between the blades 104 and the sides of the needle 50. As described above, this resilient bias allows the blades 104 to engage the sides of the needle 50, thereby causing the blades 104 to deflect outward as the needle 50 is inserted into the introducer 100. Additionally, in some examples, the blades 104 can be tapered, such that their thickness decreases as they extend distally from the introducer cannula 102. This tapering can allow the blades 104 to more easily deflect tissue, thereby reducing the penetration force required to insert the biopsy device 10 into the patient.

11-13 illustrate the progression of the introducer 100 as the needle 50 is removed from (or inserted into) the introducer 100. In particular, the needle 50 moves from a fully inserted configuration shown in FIG. 11 to an intermediate inserted state shown in FIG. 12 to an almost removed insertion state shown in FIG. 13. As shown, the seam 55 between the cannula 52 and the tube 58 of the needle 50 is substantially aligned with the gap 110 of the introducer 100. Thus, the distal end of the blade 104 can avoid directly engaging the seam 55 between the cannula 52 and the tube 58 of the needle 50. This configuration can prevent the introducer 100 from snapping onto the needle 50 as the introducer 100 is inserted into or removed from the needle 50.

In some examples, the needle 50 can include an oversized tissue piercing tip 54. For example, the tissue piercing tip 54 can include a generally flat blade 51 having a height H that is greater than the major diameter (or major cross-sectional dimension measured from top to bottom) of the outer surface of the cannula 52. The openings 114 provided at the top and bottom of the cannula 52, as described above, can provide additional clearance to allow the introducer 100 to be inserted into (or retracted from) the needle 50 without snapping onto the tissue piercing tip 54. In one non-limiting example, the opening 114 can be at least 0.002 inches, measured along the major (vertical) axis of the cannula 52, and in one embodiment, the opening 114 can be between 0.003 inches and 0.005 inches.

Figures 14 and 15 illustrate top views of the introducer 100, each with the blades 104 deflected and relaxed by the cannula 52. In the deflected state, the blades 104 are shown as having a deflection angle α relative to a projection perpendicular to the longitudinal axis of the introducer cannula 102. Similarly, in the relaxed state, the blades 104 are shown as having a relaxed angle β relative to a projection perpendicular to the longitudinal axis of the introducer cannula 102. As can be seen by comparing Figures 14 and 15 , the deflection angle α is less than the relaxed angle β. Thus, the cannula 52 of the needle 50 urges the blades 104 outward at an angle relative to the introducer cannula 102. While Figures 14 and 15 show angles α and β slightly exaggerated for illustrative purposes, it should be understood that the difference between the deflection angle α and the relaxed angle β can be any suitable value that consistently allows for deflection of the blades 104. Other blade 104 configurations having different angles α and β will be apparent to one of ordinary skill in the art in light of the teachings herein.

III. Exemplary Introducer Sheath with Two Distal Blades

FIG16 shows an exemplary alternative introducer 200 that can be used with the needle 50 in place of the introducer 100 described above. The introducer 200 is substantially identical to the introducer 100, except for the exceptions described below. In particular, similar to the introducer 100, the introducer 200 includes an introducer lumen 202, a latching feature 280, and an open distal end 206. However, unlike the introducer 100, the introducer 200 includes two distal blades 204 that engage opposing planar surfaces of the needle 50.

FIG17 shows a detailed perspective view of the blades 204 of the introducer 200. Because the introducer 200 has two blades 204, there is no gap similar to the gap 110 of the introducer 100. However, the blades 204 are symmetrical from top to bottom. Therefore, the introducer 200 can be inserted into the needle 50 in the orientation shown or in the opposite (inverted) orientation. In addition, similar to the blades 104, the blades 204 include a chamfered surface 216 located on the top (or bottom) of each blade 204.

18-20 illustrate the progression of the introducer 200 as the needle 50 is removed from (or inserted into) the introducer 200. In particular, the needle 50 moves from a fully inserted configuration shown in FIG18, to an intermediate inserted state shown in FIG19, to an almost removed insertion state shown in FIG20. As shown, the seam 55 between the cannula 52 and the tube 58 of the needle 50 is at least partially engaged by the blades 204 of the introducer 200. While the blades 204 can directly engage the seam 55 between the cannula 52 and the tube 58 of the needle 50, the configuration of two blades 204 provides fewer points of contact than the configuration of four blades 104 of the introducer 100.

Figures 21 and 22 illustrate top views of the introducer 200 with the blades 204 deflected and relaxed by the cannula 52, respectively. In the deflected state, the blades 204 are shown as having a deflection angle α relative to a projection perpendicular to the longitudinal axis of the introducer cannula 202. Similarly, in the relaxed state, the blades 204 are shown as having a relaxed angle β relative to a projection perpendicular to the longitudinal axis of the introducer cannula 202. Comparing Figures 21 and 22 shows that the deflected angle α is less than the relaxed angle β. Thus, the cannula 52 of the needle 50 urges the blades 204 outward at an angle relative to the introducer cannula 202. While Figures 21 and 22 illustrate angles α and β that are generally similar to the angles α and β shown in Figures 14 and 15 , it should be understood that the difference between the deflected angle α and the relaxed angle β can be any suitable value that consistently allows for deflection of the blades 204. Other blade 204 configurations having different angles α and β will be apparent to one of ordinary skill in the art in light of the teachings herein.

IV. Exemplary Use of the Occluder

FIG23 illustrates the introducer 100 disposed on an exemplary obturator 300. The obturator 300 includes a gripping member 330, a needle 350, and a tissue piercing tip 354. In particular, the gripping member 330 can be configured with an ergonomic configuration adapted for gripping the obturator 300. The gripping member 330 can also include a plurality of gripping features 332 to facilitate gripping by a user when gripping the gripping member 330. The latching feature 180 of the introducer 100 can be secured to the gripping member 330 by a pair of slots (not shown) within the gripping member 330.

A needle 350 extends distally from the gripping member 330. In the present example, the needle 350 has a length suitable for allowing the needle 350 to extend distally from the open distal end 106 of the introducer 100. The needle 350 has an oval cross-sectional shape similar to the needle 50. Thus, the blades 104 of the introducer 100 can engage the needle 350 similar to the gripping of the needle 50 as described above.

Also similar to needle 50, the distal end of needle 350 is equipped with a sharp tissue piercing tip 354. Tissue piercing tip 354 can allow needle 350 to penetrate patient tissue with relatively little penetration force.

In a merely exemplary use of the obturator 300, the obturator 300 can first be inserted into the introducer 100 and locked in place by the latch feature 180. The obturator 300 can then be used to penetrate the patient's tissue using the needle 350 of the obturator 300 and the cannula 102 of the introducer 100, which is about to directly contact the patient's tissue. The gripping member 330 of the obturator 300 can then be used to position the obturator 300 and the introducer 100 at a desired location within the patient's body. Once the obturator 300 and the introducer 100 reach the desired location, the obturator 300 can be removed from the introducer 100, leaving the introducer 100 in place; and the needle 50 of the biopsy device 10 can then be inserted into the introducer 100 to perform the biopsy procedure as described above.

While various embodiments of the present invention have been shown and described, further modifications of the methods and systems described herein may be accomplished through appropriate adaptations by one of ordinary skill in the art without departing from the scope of the present invention. Various modifications of such potential modifications have been mentioned, and others will be apparent to one of ordinary skill in the art. For example, the examples, embodiments, geometries, materials, dimensions, proportions, steps, and the like described above are illustrative and not required. Accordingly, the scope of the present invention should be considered in light of the following claims and is not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims (15)

1. A biopsy system, comprising: (a) A guide, wherein the guide comprises: (i) a cannula, the cannula comprising an oval cross-section, an open distal end, and an open proximal end, wherein the oval cross-section defines an inner lumen extending between the open distal end and the open proximal end, wherein the oval cross-section of the cannula comprises at least two planar sides and two non-planar sides; and (ii) at least two blades extending distally from the open distal end of the sleeve, wherein at least a portion of each of the at least two blades extends from the respective flat sides of at least two flat sides of the sleeve, wherein the at least two blades are positioned relative to the sleeve to define an open space between the at least two flat sides of the sleeve; and (b) a biopsy device, wherein the biopsy device comprises: (i) the main body, and (ii) A slender needle extending distally from the body, wherein the slender needle includes a closed distal end and an oval cross-section, wherein the closed distal end includes a sharp end, and wherein the oval cross-section defines two straight sides; The cannula of the guide is configured to slidably receive the elongated needle of the biopsy device, wherein the cannula is configured to form at least two openings between the cannula and the elongated needle along two non-flat sides when the elongated needle is slidably received within the cannula. 2. The biopsy system of claim 1, wherein at least two blades of the guide comprise two blades. 3. The biopsy system according to claim 1, wherein the guide comprises four blades. 4. The biopsy system of claim 3, wherein the four blades are arranged as a first blade pair and a second blade pair, wherein each blade pair is associated with each flat side of the oval cross-section of the cannula. 5. The biopsy system of claim 4, wherein each leaf of the first leaf pair is spaced apart by a first gap extending between each leaf of the first leaf pair, and wherein the second leaf pair is spaced apart by a second gap extending between each leaf of the second leaf pair. 6. The biopsy system of claim 1, wherein the cannula of the guide further includes a top and a bottom, wherein the top and bottom are positioned away from at least two blades. 7. The biopsy system of claim 6, wherein the top and bottom each define a beveled portion. 8. The biopsy system of claim 7, wherein each beveled portion extends distally from the distal end of the guide tube. 9. The biopsy system of claim 8, wherein each oblique cut extends laterally between at least two blades. 10. The biopsy system of claim 1, wherein the biopsy device and guide further include complementary latch features configured to selectively attach the guide to the biopsy device. 11. The biopsy system of claim 10, wherein the complementary latch feature includes a slot and a resiliently biased latch member capable of being inserted into the slot. 12. The biopsy system of claim 1, wherein at least two blades extend the same distance from the open distal end of the cannula. 13. The biopsy system of claim 1, wherein at least one of the at least two blades extends further away from the open distal end of the cannula than any other blade of the at least two blades. 14. The biopsy system of claim 1, wherein the cannula of the guide further includes a first longitudinal length, wherein the slender needle of the biopsy device further includes a second length, wherein the second length is greater than the first length. 15. A biopsy system, comprising: (a) A biopsy device, wherein the biopsy device comprises: (i) The main body; (ii) a needle extending distally from the body along a longitudinal axis, wherein the needle includes a distal end and a proximal end, wherein the needle defines an inner cavity extending between the distal end and the proximal end; and (iii) A lateral opening, spaced proximally from the closed distal end of the needle; and (b) A guide, wherein the guide comprises: (i) a cannula defining an inner lumen, wherein the lumen is sized to receive a needle from a biopsy device, wherein the lumen is sized to maintain at least two gaps between the needle and the cannula when the needle is received within the lumen; and (ii) a first blade group, wherein the first blade group includes a first pair of blades extending distally from a first side portion of the distal end of the sleeve; and (iii) A second blade group, wherein the second blade group includes a second pair of blades extending distally from a second side portion of the distal end of the sleeve; The second side of the distal end of the sleeve is opposite to the first side of the distal end of the sleeve.