JP6454794B2 - Spring injection biomarker - Google Patents

Description

  This application is a US patent application No. 14 / 534,952 filed on Nov. 6, 2014, entitled “SPECT-EJECTED BIOPSY MARKER”, and US provisional filed on Mar. 18, 2015. Application 62 / 134,715, entitled “Biopsy Marker Delivery Device”, all of which are hereby incorporated by reference in their entirety.

  The present invention relates generally to an apparatus for inserting a biomarker at a biopsy location. More specifically, it relates to a device that uses a spring to inject a marker into tissue from a side opening of the device.

  Biopsy samples can be obtained in a variety of ways with a variety of medical procedures using a variety of devices. The biopsy device can be stereotactic guidance, ultrasonic guidance, magnetic resonance imaging (MRI) guidance, positron emission mammography (PEM) guidance, breast specific gamma imaging (BSGI) guidance, or other Can be used in the way. For example, some biopsy devices can be fully operated by a user with one hand and a single insertion to take one or more biopsy samples from a patient. Also, some biopsy devices may include vacuum modules and / or controls, eg, for fluid delivery (eg, pressurized air, saline, air, vacuum), power transmission, and / or communication. Can be connected to the module. Other biopsy devices can be fully or at least partially operable without being tethered or connected to other devices.

  Only exemplary biopsy devices and biopsy system components are disclosed next. US Pat. No. 5,526,822 entitled “Automated Biopsy and Collection of Soft Tissue” issued June 18, 1996; 1999; US Pat. No. 5,928,164 entitled “Automated Biopsy and Collection of Soft Tissue” issued on July 27, 2000; January 25, 2000 "Vacuum Control System and Method for Automated" US Pat. No. 6,017,316 entitled “Iopsy Device”; “Control Apparatus for an Automated Survival Biopsy Device” issued July 11, 2000 (Control Apparatus for an Automated Biopsy Device) U.S. Pat. No. 6,086,544, entitled "MRI Compatible Surgical Biopsy Device" issued September 11, 2003. U.S. Pat. No. 849; US Patent entitled “Remote Thumbwheel for a Surgical Biopsy Device” issued October 8, 2008 No. 7,442,171; US Pat. No. 7,648,466 entitled “Manually Rotable Piercer” issued January 19, 2010; issued December 1, 2010 US Pat. No. 7,854,706, entitled “Clutch and Valving System for Tetherless Biopsy Device”, published on May 10, 2011; US Pat. No. 7,938,786, entitled “Vacuum Timing Algorithm for Biopsy Device”; “Biopsy Sample Storage” issued February 21, 2012 U.S. Pat. No. 8,118,755 entitled “Biopsy Sample Storage”; “Teetherless Biopsy Device Reusable Portion” issued on June 26, 2012 U.S. Patent No. 8,206,316, entitled "Biopsy Device with Rotatable Tissue Sample Holder" issued August 14, 2012 No. 8,241,226; and “Biopsy Device With Discrete Tissue with Discrete Tissue Chamber” issued April 22, 2014. U.S. Pat. No. 8,702,623 entitled "Chambers)". The disclosure of each of the above-cited US patents is hereby incorporated by reference.

  Other exemplary biopsy devices and biopsy system components are next disclosed. US Published Patent No. 2008/0146962 entitled “Biopsy System with Vacuum Control Module” issued June 19, 2008; issued September 4, 2008 US Published Patent Application No. 2008/0214955, entitled “Presentation of Biopsy Sample by Biopsy Device”; “Access for Biopsy Devices” issued February 14, 2013; US Published Patent No. 2013/0041256 entitled “Chamber and Markers for Biopsy Devices”; issued February 28, 2013 Published US 2013/0053724, entitled "Biopsy Device Tissue Sample with Bulk Chamber and Pathology Chamber", published June 13, 2013; US published patent 2013/0150751 entitled “Biopsy Device with Slide-In Probe” issued on December 5, 2013; US Published Patent No. 2013/0324882 entitled “Control for Biopsy Device”; and “Life” issued February 6, 2014 US Published Patent No. 2014/0039343, entitled “Biopsy System”. The disclosures of each of the above-cited US published patents are hereby incorporated by reference.

  In some environments it may be preferable to display the location of the biopsy site for later reference. For example, one or more markers can be deposited at a biopsy site before, during or after a tissue sample is taken from the biopsy site. An example of a marker placement tool is Device Medical Products, Inc., Cincinnati, Ohio. Are MAMMOMARK ™, MICROMARK ™ and CORMARK ™ brand devices. Other exemplary devices and methods for marking a biopsy site are next disclosed. US Published Patent Application No. 2009/0209854 entitled “Biopsy Method” issued on August 20, 2009; “Devices Useful for Imaging” issued on October 29, 2009; US Published Patent Application No. 2009/0270725 entitled “In Imaging”; US Published Patent Application No. 2010/0049084 entitled “Biopsy Marker Delivery Device” issued February 25, 2010; US Published Patent No. 2011/0071423 entitled “Flexible Biopsy Marker Delivery Device” issued on March 24, 2011; US Published Patent No. 2011/0071424 entitled “Biopsy Marker Delivery Device” issued on March 24, 011; “Positioning component issued on March 24, 2011” US Patent Publication No. 2011/0071391, entitled “Biopsy Marker Delivery With Positioning Component”, which is issued on May 8, 2001; U.S. Pat. No. 6,228,05 entitled "Devices for Marking and Defining Particulate Locations in Body Tissue" No .; US Pat. No. 6,371,904 entitled “Subcutaneous Cavity Marking Device and Method” issued on Apr. 16, 2002; issued on Jan. 31, 2006 US Pat. No. 6,993,375 entitled “Tissue Site Markers for In Vivo Imaging”; issued on February 7, 2006; US Pat. No. 6,996,433 entitled “Imageable Biopsy Site Marker”; issued on May 16, 2006, “Devices for Defining and Marking Tissues (Devices) or US Pat. No. 7,044,957 entitled “Or Defining and Marking Tissue”; “Tissue Site Markers for In Vivo Imaging” issued May 16, 2006. U.S. Patent No. 7,047,063 entitled; "Methods for Marking a Biopsy Site" issued June 12, 2007, U.S. Patent No. 7,047,063, entitled "Methods for Marking a Biopsy Site" 229,417; and “Marker Device and Method of Deploying,” published on December 16, 2008, using a surgical biopsy device. Cavity Marker Using a Surgical Biopsy Device) U.S. Patent No. 7,465,279 entitled ". The disclosures of each of the above-cited US patents and US published patents are incorporated herein by reference.

  Aspects of the invention include a plunger and / or a push rod such as a shaft, a tube or other cannula, a ramp portion, a side opening, and at least a portion of the shaft. As well as devices and systems that include springs that are extended to, and methods of making and using them. According to some aspects of the invention, the device can be configured to fire the marker with the same amount of force each time it is used. In some aspects, the device can operate independently of any force applied by the user, ensuring uniform and repeatable placement of the markers.

  Additional advantages and novel features of these aspects will be set forth in part from the description which follows, and in part will be apparent to those skilled in the art upon consideration of the embodiments of the present invention or upon learning by those skilled in the art. It will be.

1 is a perspective view of an exemplary marker transport device according to aspects of the present invention. FIG. 2 shows a cross-sectional view of the distal end of the marker transport device of FIG. 1 with respect to the cross-section taken along line 2-2 of FIG. FIG. 2 is a side elevational view of the distal end of the shaft of the marker delivery device of FIG. 1. FIG. 2 is a partial cross-sectional view showing the distal end of the marker delivery device of FIG. 1 with the shaft and spring in an initial proximal position. FIG. 2 is a partial cross-sectional view showing the distal end of the marker delivery device of FIG. 1 with the shaft and spring partially advanced distally. FIG. 2 is a partial cross-sectional view of the distal end of the marker delivery device of FIG. 1 with the shaft and spring fully advanced in the distal direction. FIG. 4 is a cross-sectional view showing the knurl of the marker transport device of FIG. FIG. 2 is a perspective view of an exemplary marker for use with the marker transport apparatus of FIG. FIG. 2 is a perspective view of another exemplary marker for use with the marker transport apparatus of FIG. 1. FIG. 2 is a perspective view of another exemplary marker for use with the marker transport apparatus of FIG. 1. FIG. 2 is a perspective view of another exemplary cannula for use with the marker delivery device of FIG. FIG. 9 is a cross-sectional view of the cannula of FIG. 8 with respect to the cross section taken along line 9-9 of FIG. FIG. 6 is a perspective view of another exemplary marker transport device in accordance with aspects of the present invention. FIG. 10 is a side view showing the marker transport device of FIG. 9 together with the plunger in the non-operation position. FIG. 10 is another side view of the marker transport device of FIG. 9 with the plunger in a partially actuated position. FIG. 10 is another side view of the marker transport device of FIG. 9 with the plunger in a fully activated position. FIG. 6 is a perspective view of another exemplary marker transport device in accordance with aspects of the present invention. FIG. 13 is a cross-sectional view of the marker transport device of FIG. 12 with respect to the cross section taken along line 13-13 of FIG. It is a figure which shows the edge part of the knurl of the marker conveying apparatus of FIG. FIG. 6 is a perspective view of another exemplary cannula for use with the marker delivery device of FIG. FIG. 16 is a cross-sectional view of the cannula of FIG. 15 with respect to the cross section taken along line 16-16 of FIG. FIG. 6 is a side view of one of various features of an exemplary apparatus having a broken portion showing that the length of the structure may be a preselected length according to an aspect of the present invention. It is the longitudinal cross-sectional view taken along the 1B-1B line of FIG. 17A. FIG. 17B is an enlarged view of the distal end of the structure shown in FIG. 17B. FIG. 17B is a diagram showing another embodiment in which a dimple replaces the annular crimp of FIG. 17A. It is a figure which shows the side view of this apparatus roughly. FIG. 18B is a side cross-sectional view in the length direction of the structure shown in FIG. 18A. It is a figure which shows the top view of the termination | terminus surface of the structure shown to FIG. 18A. FIG. 6 is a side view of various features of an exemplary apparatus according to aspects of the present invention.

  The following description of specific examples of various aspects of the invention should not be used to limit the scope of the invention. Other examples, features, aspects, variations and advantages of the technology will become apparent to those skilled in the art from the following description of one of the best modes considered for carrying out the technology. As will be realized, the embodiments of the present invention may be otherwise divided and clearly embodied without departing from the present specification. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature and not as restrictive.

  1-4 show a marker transport device 10 that can be used with a biopsy device or target set to transport markers to a biopsy site. The marker transport device 10 includes a main body 20 and a cannula 40. As shown in FIG. 1, the body 20 includes an elongate housing 22, a grip 24, an elastic member 26 and a plunger 28. The housing 22 connects the main body 20 to the cannula 40. The housing 22 may also include other actuation components of the marker transport device 10 such as seals, springs, bushings, or other actuation components that may be apparent to those skilled in the art in view of the teachings herein. Can be enclosed.

  The grip 24 is located at the proximal end of the housing 22 and is configured to be gripped by, for example, a user's finger. As described in more detail below, the grip 24 is generally configured such that the marker transport apparatus 10 can be operated with one hand of the user. The grip 24 in this example is configured integrally with the housing 22. In other examples, the grip 24 may instead be separated from the housing 22.

  The elastic member 26 is disposed between the grip 24 and the plunger 28. In particular, the elastic member 26 of the present example includes a leaf spring having two openings 27 at both ends of the elastic member 26. The opening 27 is configured to slidably receive the shaft 30. The shaft 30 is slidable with respect to the main body 10 in order to selectively eject the marker 60 from the marker conveying device 10. Although the elastic member 26 is illustrated as a leaf spring, it should be understood that in other embodiments, any other suitable elastic mechanism such as a coil spring may be used.

  Plunger 28 is located at the proximal end of shaft 30. In general, plunger 28 is configured to be pushed by the user to actuate shaft 30 distally relative to body 20 and cannula 40. Further, as shown in the figure, the plunger 28 contacts the elastic member 26, so that the elastic member 26 remains in the proximal position shown in FIG. 1 even after the user operates the marker conveying device via the plunger 28. Can be returned. As will be described later, the plunger 28 and the grip 24 are configured together so that the user grasps the grip 24 with two fingers (e.g., eating finger and middle finger) and the plunger 28 with another finger (e.g., thumb). it can. Although not shown, the plunger 28 includes a plunger lock or other locking feature to allow a user to ratchet or lock the plunger 28 in place (eg, in a proximal position). To lock the plunger 28 and / or lock the plunger 28 in the distal position). Suitable locking features can include elastic latching arms, bayonet latch features, screw-type features, and the like.

  The cannula 40 is comprised of a long tubular shaft that extends distally from the housing 22. Generally, the cannula 40 is extended distally by a length suitable for insertion into a biopsy device or target set so that it can be extended to the biopsy site to carry the marker 60. In this embodiment, the distal end of cannula 40 includes a side opening 42 and a distal tip 44. As shown in FIG. 1, the side opening 42 is located proximal to the distal end of the cannula 40. As will be appreciated, the particular location of the side opening 42 relative to the distal end of the cannula 40 is configured such that the side opening 42 can be aligned with the corresponding side opening of the needle of the biopsy device.

  As best shown in FIG. 2, the distal tip 44 is inserted into the distal end of the cannula 40 and extends longitudinally into at least a portion of the side opening 42. The proximal end of the distal tip 44 includes a ramp 46. As will be described in more detail below, the ramp 46 is configured to guide the marker 60 from a cannula lumen 48 that extends longitudinally through the cannula 40 and communicates with the side opening 42.

  Cannula lumen 48 extends from the proximal end of cannula 40 to the distal end of cannula 40. Although not shown in FIG. 2, it should be understood that in some embodiments, the cannula lumen 48 can be extended into the housing 22 so that the shaft 30 of the body 20 can communicate with the lumen. is there. In particular, as shown in FIG. 2, the shaft 30 extends completely through the body 20 and into the cannula 40 before it is terminated near the distal end of the cannula 40. As will be described in more detail below, the shaft 30 is slidably disposed within the cannula lumen 48 such that the marker 60 engages the marker 60 and sends the marker 60 onto the ramp portion 46 and further out of the side opening 42. Is done. In some aspects, the ramp 46 ramp can control the angle at which the marker 60 is ejected from the lumen of the cannula 48.

  Although the shaft 30 of this embodiment is illustrated as being coaxially disposed within the cannula lumen 48, in other embodiments, the shaft 30 is terminated within the body 20 and other members, shafts or rods (rod). ) May be extended into the cannula lumen 48.

  According to some embodiments of the invention, as shown in FIG. 17A, the device can include a plunger 172 having an expanded proximal end 171 that can act as a handle for a user, for example. As shown in FIG. 17B, the proximal end 173 a of the long shaft 16 can be received within a bore 172 a formed by the plunger 172 such that the shaft 173 can move with the plunger 172. Can be fixed to.

  In this manner, the long cannula 174 can slidably receive the distal end of the shaft 173. As shown in FIG. 17C, according to some aspects, an annular crimp 174a may be formed in the cannula 174 near its distal end. According to some aspects, the cannula 174 can include a side opening 174b in which a marker 176 is ejected from the lumen of the cannula 174.

  As shown in FIG. 3A, the distal end of the shaft 30 of the present example includes a spring 90 that extends over at least a portion of the distal end of the shaft 30. In particular, the spring 90 of this embodiment includes a multi-pitch coil spring that is coaxial with at least a portion of the shaft 30, for example, 1.9 to 2.4 pounds (lbs) per 1/10 inch of compression. Configured to generate a force. In this embodiment, the spring 90 is composed of biocompatible stainless steel, although any other suitable biocompatible material may be used. The spring 90 includes a first pitch region 92, a second pitch region 94, and a third pitch region 96. The first pitch region 92 and the third pitch region 96 have substantially the same pitch. It should be understood that the term “pitch” as used herein generally indicates the spacing between each coil of the spring 90. For example, the pitch of the first pitch region and the third pitch region 96 may be relatively smaller than the pitch of the second pitch region 94. The term “pitch” can also be understood to relate to a specific number of coils per axial distance unit, eg coils per inch.

  The spacing between the coils of the spring 90 in the first pitch region 92 and the third pitch region 96 of the present example may be relatively small or substantially zero, and the first pitch region 92 and the third pitch region region 96. Each coil is in contact or nearly in contact. As will be described later, such a pitch allows very little compression of the first pitch region 92 and the third pitch region 96 to occur when the spring 90 is compressed. However, the spacing between the coils of the spring 90 in the second pitch region 94 is relatively smaller than the compact spacing between the coils of the spring 90 in the first pitch region 92 and the third pitch region 96. large. Thus, when the spring 90 is compressed, the second pitch region 94 can be compressed much more than the first pitch region 92 and the third pitch region 96. Although the pitch regions 92, 94, 96 are illustrated as having a particular pitch, each pitch region has any other suitable pitch as will be apparent to those skilled in the art in view of the teachings herein. Should be understood.

  The first pitch region 92 and the third pitch region 96 may include any appropriate number of coils, but the first pitch region 92 and the third pitch region 96 of the present embodiment each have 24 to 25 coils. including. When the spring 90 is compressed, the first pitch region 92 and the third pitch region 96 are configured to be relatively uncompressed as compared to the second pitch region 94, but the first pitch region 92 and the third pitch region are not compressed. Region 96 can still be configured to bend in the lateral direction, and shaft 30 can still exhibit some lateral movement within cannula 40 while maintaining contact with marker 60 via spring 90. . Further, due to the difference between the pitch of the second pitch region 94 and the pitch of the first and third pitch regions 92 and 96, for example, when the spring 90 receives a longitudinal compression load during the operation of the plunger 28, The pitch region 94 can be compressed before the first and third pitch regions 92,96.

  According to some embodiments of the invention, the spring 20 may be secured to the distal end of the shaft 174, as shown in FIGS. 17B and 17C. According to some aspects, the spring may include only two pitch regions 175b and 175c. In some aspects, the coils can be tightly packed against each other at the end of the spring in the pitch region 175c. According to some aspects, the proximal pitch region 175b can include a loosely compressed coil. As will be described below, it should be understood that a spring having two pitch regions can function similarly to a spring having three pitch regions.

  Returning to FIG. 3A and described in more detail below, the spring 90 is generally fixedly mounted on the shaft 30 and the spring 90 contacts the marker 60 first and the shaft 30 advances and is compressed so that the shaft 30 is Eventually, the marker 60 can be contacted. In this embodiment, the spring 90 is illustrated as being fixedly installed on the shaft 30 at a point adjacent to the distal end of the shaft 30, and a portion of the first pitch region 92 is from the distal end of the shaft 30. Extended in the distal direction. Of course, in other examples, any suitable portion of the spring 90 can be extended from the distal end of the shaft 30. The spring 90 of this embodiment may be fixedly installed on the shaft 30 by laser welding, for example. In other examples, the shaft 30 can include an annular protrusion or multiple protrusions that can simply prevent the spring 90 from sliding proximally along the shaft 30. In other examples, the shaft 30 can include an annular protrusion or a plurality of protrusions that can be configured to secure the spring 90 by a press or interference fit. In other examples, other suitable features or methods of securing the spring 90 to the shaft 30 may be used, such as by screws, pins, or adhesives, as will be apparent to those skilled in the art in view of the teachings herein.

  As shown in FIG. 17B, the apparatus may include an annular detent 175a weld formed integrally with the shaft 173 so that the spring does not slip relative to the shaft. The proximal end of the spring can be fixed.

  As shown in FIG. 3A, the marker 60 of the present example includes a biodegradable or other resorbable body 62. The resorbable body 62 may be generally cylindrical and may be composed of collagen, hydrogel, and / or any other suitable material. The resorbable body 62 is a metallic (eg, titanium), generally radiopaque marker element 64 (dotted line) disposed within or resting on the resorbable body 62. Can be included). Although the marker element 64 of the present embodiment is formed in a coil spring, it is understood that the marker element 64 may have any other shape suitable for improving radiographic visibility. Should do. It should also be understood that metal is merely one example of a material that can be used to form marker element 64. A variety of other suitable materials that can be used will be apparent to those skilled in the art in view of the teachings herein.

  In certain instances, it may be preferable to provide the marker transport device 10 with a marker 60 retention feature for selectively securing the marker 60 within the cannula 40. For example, the cannula 40 of this embodiment includes two retaining dimples 50 disposed within the cannula lumen 48 proximal to the side opening 42. As can best be seen from FIG. 4, the dimple 50 can be placed near the bottom of the cannula 40 at a distance from the side opening 42. The dimple 50 can be protruded inside the cannula lumen 48 in a hemispherical shape, for example. Accordingly, the dimple 50 can be configured as a stop member to engage at least a portion of the marker 60 and retain the marker 60 within the cannula lumen 48. However, since the resorbable body 62 is composed of collagen, hydrogel, and / or other deformable material, the marker 60 is relatively elastic so that it is selectively constrained by the shaft 30 past the dimple 50. Characteristics can be expressed. In contrast, the marker 60 may be small compared to the inner diameter of the cannula 40 so that when the shaft 30 pushes the marker 60, the marker 60 can be pushed onto the dimple 50 and further upward. Although cannula 40 is illustrated as including two dimples 50, it should be understood that in other examples, cannula 40 can include any other suitable number of dimples 50.

  As shown in FIG. 17D, two circumferentially spaced dimples 174d can be formed in the cannula 174. As shown in FIG. 17D, if the upper end of the side opening of the cannula 174 is defined as a 0 degree (0 degree) position, the first dimple can be located at a substantially 135 degree (135 degree) position. The dimples can be located at approximately 225 degrees (225 degrees). That is, it can arrange | position to the position (offset position) where the angle of the circumferential direction is the same from side opening. According to some embodiments, the annular crimp 174a can be formed by a number of closely spaced dimples. However, the preferred number of dimples that are equally spaced and circumferentially spaced may be at least two or more than eight, as shown. According to some aspects, for example, if eight dimples are selected, there can be one dimple at the 0 degree (0 degree) position, and thereafter approximately every 45 degrees (45 degrees) around the cannula 174. There can be one dimple.

  Additionally or alternatively, the dimple 50 can include other shapes other than a hemispherical shape. For example, the dimple 50 may be pyramidal, cubic, rhombus or any other suitable shape, which will be apparent to those skilled in the art in view of the teachings herein. As another mere illustrative example, irregularities such as annular protrusions and crimps may be formed extending in the circumferential direction inside the lumen 48 as an alternative to the dimple 50. In another merely illustrative example, a single piece relatively flexible and elastic flap or tab with cannula 40 extends inside lumen 48 as another alternative for dimple 50. Can be done.

  According to one embodiment of the invention, as shown in FIGS. 18A-C, cannula 174 can include a flap 177, which is not visible in the side elevation view of FIG. 18A, but is longitudinal in FIG. 18B. It can be confirmed by a side sectional view and a longitudinal plan view of 18C. According to some aspects, the flap 177 and cannula 174 can be integrally formed with each other, for example, the flap provides a detent, which is a proximal-to-distal displacement of the marker 176 by the shaft. For example, the flap 177 can perform a function similar to the annular crimp or dimple described herein. According to some embodiments, the flap 177 can be used when the marker 176 is formed of a material that is not flexible and resilient.

  As shown in FIG. 19, according to some embodiments, a bulge or protrusion 26 can be formed in the lumen of the cannula 174, such bulge being similar to the flap 177. Can perform the functions. For example, the protrusion 178 and the flap 177 can be configured to flatten when a rigid marker 176 is pushed over such a feature.

  3B to 3D show usage examples of the marker transport device 10. As can be seen from FIG. 3B, the marker 60 is initially positioned within the cannula lumen 42 proximate the dimple 50. The user can insert the cannula 40 into the biopsy device or target set to transport the marker 60 to the biopsy site along with the biopsy device or target set already located in the tissue at the biopsy site. The cannula 40 may be positioned such that the side opening 42 is angularly and longitudinally aligned with the complementary side opening of the biopsy device or target set needle or cannula. For example, once the cannula 40 is inserted into the biopsy device or target set and properly positioned, the user can grasp the grip 24 and push the plunger 28 with one hand or the other to begin placement.

  When the plunger 28 is pressurized to the distal end, the shaft 30 can be advanced distally relative to the cannula 40 and the body 20 as shown to progress between FIGS. 3B and 3C. As the distal end of the shaft 30 approaches the marker 60, the spring 90 can initially contact the marker 60. As shown in FIGS. 3B and 3C, such contacts compress the spring 90 and store potential energy in the spring 90 as the shaft 30 advances further.

  Additional advancement of the shaft 30 can eventually lead to direct contact between the marker 60 and the distal end of the shaft 30. As shown in FIG. 3C, the distal end of the shaft 30 can be generally aligned with the distal end of the spring 90 at this stage. When such direct contact is initiated, the shaft 30 begins to push the marker 60 within the cannula 40, thereby past and / or across the dimple 50 and even outside the side opening 42. Move forward. If the marker 60 is at the end of the dimple 50, the spring 90 can begin to expand due to the potential energy generated during the compression of the spring 90. Such expansion of the spring 90 advances the marker 60 laterally over the ramp portion 46 of the distal tip 44 and advances outwardly through the side opening 42, and can be seen from FIG. Can be advanced into the biopsy site. It should be understood that the first pitch region 92 can be bent over the dimple 50 and extended past the dimple 50. Thus, for example, the configuration of the spring 90 is such that the spring 90 is laterally positioned within the lumen 48 such that the spring 90 can travel beyond the dimple 50 without requiring any lateral deflection of the shaft 30 within the lumen. To be able to be deflected in the direction. The coils forming the first pitch region 92 simply pass through the dimple 50 and can slide relative to each other. In a variation where the dimples are arranged by a larger angular range within the lumen 48 (eg, as in the cannula 640 described below), the spring 90 is still deformed to pass far beyond the dimple 50. Can. For example, the coils forming the first pitch region 92 slide relative to the longitudinal axis of the lumen 48 and tilt obliquely to reduce the effective outer diameter of the spring 90 and the spring 90 is It passes through the space formed between them.

  FIG. 5 shows another exemplary marker 160 that can be used in addition to or in place of marker 60 as described above. The marker 160 in this example is substantially the same as the marker 60. For example, similar to marker 60, marker 160 can include a biodegradable or resorbable body 162. The resorbable body 162 may be generally cylindrical and may be composed of collagen, hydrogel, and / or any other suitable material. Similar to the resorbable body 62, the resorbable body 162 is a metallic, generally radiopaque, that is disposed within or carried by the resorbable body 162. A marker element 164 can be included. However, unlike the marker element 64, the marker element 164 of this example is a disc-shaped center having three extended protrusions 168 that protrude radially outward from the central member 166 and further out of the resorbable body 162. Includes member 166 (shown in dotted lines). It should also be understood that metal is merely illustrative of one type of material that can be used to form marker element 164. A variety of other suitable materials that can be used will be apparent to those skilled in the art in view of the teachings herein.

  In some examples, the long protrusion 168 can protrude radially outward from the central member 166 to provide friction against the interior of the cannula 40. Thus, for example, the long protrusion 168 can be configured to contact the interior of the cannula 40. For example, such a configuration can be used with or in place of the dimple 50 to retain the marker 160 within the cannula 40 to prevent the marker 160 from accidentally falling out of the cannula 40. The long protrusion 168 can also engage tissue at the biopsy site to secure the marker 160 to the biopsy site and prevent movement of the marker 160.

  FIG. 6 shows another exemplary marker 260 that may be used in addition to or instead of marker 60 as described above. The marker 260 in this example may be substantially the same as the marker 60. For example, similar to marker 60, marker 260 can include a biodegradable or resorbable body 262. However, unlike the resorbable body 62, the resorbable body 262 can include a hybrid of at least two materials. For example, the resorbable body 262 of this embodiment can include a substantially cylindrical collagen intermediate portion 261, two hydrogel intermediate portions 263, and two collagen end portions 265. Similar to the resorbable body 62, the resorbable body 262 is a metallic, generally radiopaque marker element that is disposed within or otherwise carried within the resorbable body 262. H.264 (illustrated with dotted lines). However, unlike the marker element 64, the marker element 264 of the present example may be generally rectangular with a central twist 266 so that it can be configured to improve the radiation visibility of the marker element 264. It should also be understood that metal is merely one example of a material that can be used to form marker element 264. A variety of other suitable materials that can be used will be apparent to those skilled in the art in view of the teachings herein.

  FIG. 7 shows another exemplary marker 360 that may be used in addition to or instead of marker 60 as described above. The marker 360 in this example may be substantially the same as the marker 60. For example, similar to marker 60, marker 360 can include a biodegradable or other resorbable body 362. However, unlike the resorbable body 62, the resorbable body 362 can include a hybrid of at least two materials. For example, the resorbable body 362 of this embodiment can include a generally cylindrical collagen outer shell 361 having a hydrogel inner core 363. Similar to the resorbable body 62, the resorbable body 362 is a metallic, generally radiopaque marker element that is disposed within or otherwise carried within the resorbable body 362. 364. However, unlike the marker element 64, the marker element 364 of the present example can be rectangular with a generally central twist 366 that is configured to improve the radiation visibility of the marker element 364. It should also be understood that metal is merely one example of a material that can be used to form marker element 364. A variety of other suitable materials that can be used will be apparent to those skilled in the art in view of the teachings herein.

  8 and 9 show an exemplary alternative cannula 440 that can be integrated into the biopsy marker device 10 described above. The cannula 440 of this embodiment may be substantially the same as the cannula 40 described above unless otherwise noted herein. For example, the cannula 440 includes a long tubular shaft 441 that includes a proximal side opening 442 of the distal tip 444 and a cannula lumen 448 that extends through the cannula 440. However, unlike cannula 40, cannula 440 can include a sleeve-shaped metal sheath 452 disposed on at least a portion of the distal tip of cannula 440. It should also be understood that metal is merely one example of a material that can be used to form the skin 452. A variety of other suitable materials that can be used will be apparent to those skilled in the art in view of the teachings herein. Metal skin 452 can be configured to provide structural reinforcement to the distal end of cannula 440. For example, the metal skin 452 can prevent the end of the cannula 440 from buckling or other deformation during use of the cannula 440. Additionally or alternatively, when the cannula 440 is formed of a material that is less rigid than the metal skin 452, the metal skin 452 is formed of a relatively flexible or resilient material of the cannula 440 that forms a side opening. It is possible to prevent the edges from being rubbed or cut by edges. The cannula 440 is inserted into the side opening of the biopsy needle.

  The side opening 442 of this embodiment can be integrated into both the cannula 440 and the metal skin 452. As shown in FIG. 8, the side openings 442 are cut from the cannula 440 and the metal skin 452 at an angle so that the cannula 440 and the metal skin 452 form inclined edges 445, 454, 456 aligned together. For example, the metal skin 452 can include a beveled edge 454 and a proximal beveled edge 456. The distal beveled edge 454 of the metal skin 452 can be aligned with the ramp portion 446 of the distal tip 444, and the distal beveled edge 454 and the ramp portion 446 are oriented at a substantially similar angle. The Similarly, the proximal beveled edge 456 of the metal skin 452 can be aligned with the cannulated beveled proximal edge 445, and the two proximal edges 445, 456 are oriented at substantially similar angles. .

  The inclined edges 445, 454, 456 and the ramp portion 446 are suitable for reducing trauma to the tissue while still retaining the side openings 442 in a sufficiently large dimension for the markers 60, 160, 260, 360 to pass through. Can be tilted at an angle. In this embodiment, the inclination angle of the edge 454 inclined at the distal end and the ramp portion 446 is steeper than the inclination angle of the edges 456 and 445 inclined proximally. Although a particular relationship between the distal sloped edge 454 and the ramp 446 and the proximal sloped edges 445, 456 is illustrated, it is not intended to be a limitation on the illustrated example, and in other examples Each tilt angle may be varied as will be understood by those skilled in the art in view of the teachings herein.

  As shown in FIG. 9, the distal tip 444 of this example is integral with the shaft 441. The distal tip 444 and the shaft 441 can be configured to receive the metal skin 452 such that the metal skin 452 supports the distal tip 444. In some variations, for example, the distal tip 444 and shaft may be overmolded by overmolding, such as by allowing the distal tip 444 and shaft 441 to be injection molded into the metal skin 452. 441 can be attached. In other examples, the metal skin 452 can simply be attached to the distal tip 444 and shaft 441 by adhesive bonding, mechanical fastening or any other suitable fastening scheme.

  The metal skin 452 of this embodiment includes a metallic biocompatible material such as stainless steel, titanium, and / or any other suitable metal. However, no limitation on these examples is intended. For example, in another example, the metal skin 452 can include a relatively high density plastic relative to the shaft 441 and the distal tip 444. In yet another example, the metal skin 452 can include a ceramic material. In yet other examples, the metal skin 452 can be made of any other suitable material as will be apparent to those skilled in the art.

  FIGS. 10-11C show another exemplary marker transport device 510 similar to the marker transport device 10 described above. For example, the marker delivery device 510 can include a body 520 and a cannula 540. The body 520 can include a long housing 522, a grip 524 and a plunger 528. The housing 522 may be substantially the same as the housing 22 described above. However, unlike the housing 22, the housing 522 of this embodiment includes additional components configured to provide a plurality of operating positions relative to the plunger 528, as described in further detail below. Can do.

  Similar to the plunger 28 described above, the plunger 528 of this embodiment can be located at the proximal end of the shaft 530 that extends longitudinally through the body 520 and the cannula 540. Further, similar to the plunger 28 described above, for example, the plunger 528 of this example can be used together with the grip 524 for the operation of the marker conveying device 510 with one hand. However, unlike the plunger 28, the plunger 528 of the present embodiment can be configured to have multiple operating positions, as will be described in more detail below.

  The cannula 540 may be substantially the same as the cannula 40 described above and may be composed of a long tubular shaft extending distally from the housing 522. In general, to the biopsy site such that cannula 540 carries any one of markers 60, 160, 260, 360 described herein via side opening 542 near the distal end of cannula 540. As can be extended, cannula 540 can be extended distally by a length suitable for insertion into a biopsy device or target set.

  11A to 11C show exemplary operation modes of the marker transport device 510. FIG. As can be seen from FIG. 11A, the plunger 528 of the body 520 initially starts from a proximal position. When the plunger 528 is placed in the initial position, the marker delivery device 510 is inserted into the biopsy device or target set and positioned at the side opening 542 of the cannula 540 at the biopsy site, for example, the side opening 542 is a biopsy device or It can be aligned longitudinally and at a predetermined angle with similar side openings of the target set.

  Once the marker transport device 510 is located within the biopsy device or target set, the user may wish to place the markers 60, 160, 260, 360 at the biopsy site. To position the markers 60, 160, 260, 360, the user can advance the plunger 528 to a partially activated position as shown in FIG. 11B. In this embodiment, the housing 522 is configured to advance the shaft 530 to eject the markers 60, 160, 260, 360 from the side openings 542 when the plunger 528 is advanced to a partially activated position. Including various elements.

  In certain instances, it may be preferable to rotate the cannula 540 within the biopsy device or target set after placement of the markers 60, 160, 260, 360. For example, after placement of the markers 60, 160, 260, 360, the markers 60, 160, 260, 360 can be placed on the side of the cannula 540 such that at least a portion of the markers 60, 160, 260, 360 reenters the side opening 542. In some cases, it may be held near the opening 542. In this case, since the markers 60, 160, 260, 360 may be caught between the side openings 542 and the corresponding side openings of the biopsy device or target set, the removal of the marker transport device 510 is performed by the markers 60, 160, 260, 360. 360 may be damaged. Thus, the marker delivery device 510 facilitates removal of the cannula 540 without, for example, the markers 60, 160, 260, 360 located between the side opening 542 and the corresponding side opening of the biopsy device or target set. The cannula 540 can be configured to selectively rotate.

  As shown in FIG. 11C, plunger 528 is advanced to a fully actuated position to initiate rotation of cannula 540 relative to body 520. It should be understood that the interior of the housing 522 can include springs, levers, gears, cams, or other mechanical devices that can be assembled to cause rotation of the cannula 540 to accomplish such functions. is there. Various components and features that can be used to provide such rotation of the cannula 540 relative to the body 520 in response to full advancement of the plunger 528 relative to the body 520 are known to those skilled in the art in view of the teachings herein. It will be obvious. In this example, it should be understood that the components of the housing 522 can be configured to rotate the cannula 540 180 degrees relative to the body 520, for example. In other examples, the housing 522 can be configured to rotate the cannula 540 at any suitable angle relative to the body. Merely by way of example, the housing 522 can be configured to rotate the cannula 540 through 90 °, 270 °, or any other suitable radial distance.

  For example, when the plunger 528 is advanced to a fully activated position to rotate the cannula 540, the marker delivery device 510 can be removed from the biopsy device or target set. Alternatively, in some embodiments, the marker transport device 510 can be provided to place a plurality of markers 60, 160, 260, 360. In such an example, the housing 522 can be configured to return the cannula 540 back to its original position for placement of other markers 60, 160, 260, 360 when the plunger 528 is selectively retracted. The sequence described above can be started again. For example, while the sequence described above has been described as including two separate advancements of the plunger 528 by the user, in other examples, the plunger 528 may be selectively advanced in a single stroke. Should be understood. In such an example, among others, the markers 60, 160, 260, 360 are placed, after which the cannula 540 can be immediately rotated.

  12-14 show another exemplary marker transport device 610 similar to the marker transport device 10 described above. For example, the marker delivery device 610 can include a body 620 and a cannula 640. The body 620 can include a long housing 622, a grip 624 and a plunger 628. Since the housing 622, grip 624 and plunger 628 may be substantially the same as the housing 22, grip 24 and plunger 28 described above, individual details of such elements will be repeated at this point in the description. Absent.

  Cannula 640 may be substantially the same as cannula 40 described above in that it can be configured with a long tubular shaft extending distally from housing 522. Generally, as shown in FIGS. 12-14, the cannula 640 is extended to the biopsy site to carry one of the markers 60 described herein, 60, 160, 260, 360. It is extended distally by a length suitable for insertion into the device or target set. However, unlike the cannula 40, the cannula 640 of this example does not have a side opening. Alternatively, cannula 640 can include an open distal tip 644 that communicates with cannula lumen 648 extending through cannula 640, for example. Accordingly, the cannula 640 can be configured to place the marker 60 longitudinally through the open distal tip 644.

  As best seen from FIGS. 13 and 14, the cannula 640 may further include a plurality of dimples 650 similar to the dimples 50 of the cannula 40. For example, the dimple 650 can be configured to selectively retain the marker 60 within the cannula 240 generally. The dimple 650 may include a hemispherical shape that is substantially similar to the dimple 50 described above. However, unlike the cannula 40 as described above, the cannula 640 of this example can include three dimples 650. As shown in FIG. 14, the dimples 650 can be placed equidistant around the inner diameter of the cannula 640. Similar to the dimple 50 described above, the dimple 650 of the present embodiment may have any other suitable shape and / or shape as understood by those having ordinary skill in the art in view of the teachings of the present invention. It should be understood that configurations can be included.

  15 and 16 show an exemplary alternative cannula 740 that can be integrated into the biopsy marker device 10 described above. The cannula 740 of this embodiment may be substantially the same as the cannula 40 described above unless otherwise noted herein. For example, the cannula 740 of this embodiment can include a long tubular shaft 741 that can include a side opening 742 proximate the distal tip 744. The shaft 741 can additionally form a cannula lumen 748 that extends through the cannula 740 and communicates with the side opening 742. Unlike cannula 40, side opening 742 of cannula 740 may have a tear drop shape that widens as side opening 742 extends proximally. Thus, for example, the distal portion of side opening 742 may be narrower than the proximal portion of side opening 742.

  It should be understood that in some examples, at least a portion of the side opening 742 (eg, the end of the side opening 742) can also be made slightly smaller in size than the side opening 42 described above. is there. Such sizing can, for example, allow side openings 742 to accommodate smaller markers.

  As shown in FIG. 16, cannula 740 may differ from cannula 40 in that distal tip 744 may include a composite ramp portion 746. For example, the distal tip 744 can include three separate ramp portions 743, 745, 747 and two relatively flat portions 749, 751. In other embodiments, the specific angle of each ramp portion 743, 745, 747 may vary, but the ramp portions 743, 745, 747 are shown in FIG. 16 to be inclined at a similar angle. In general, the ramp portions 743, 745, 747 can be configured to progressively deflect a marker (not shown) through the side opening 742. Such a gradual step is preferred to prevent the marker from escaping from the cannula 40 early after it has been delivered to the biological site and to prevent the marker from re-entering the side opening 742.

  The flat portions 749, 751 may be generally parallel, for example, along a flat plane relative to the longitudinal axis of the cannula 740. As the marker moves from the ramp portions 743, 745, 474 to the ramp portions 743, 745, 747, the flat portions 749, 751 provide a distance between the ramp portions 743, 745, 474 to change the trajectory. Can be configured. For example, in an exemplary use, as the marker is advanced distally, the marker can first rise on the first ramp portion 743. The first ramp portion 743 can provide some resistance against the distal movement of the marker. By way of example only, the first ramp portion 743 is included in the description of US Pat. No. 8,532,747, entitled “Biopsy Marker Delivery Device” issued September 10, 2013. Constructed and operable at least in part, which is hereby incorporated by reference.

  Once the marker passes the first ramp portion 743, the marker can move along the first flat portion 749 and rise on the second ramp portion 745 at an angle substantially parallel to the angle of the second ramp portion 745. . The second ramp part 745 provides a cam surface and can discharge the marker through the side opening 742. The second flat portion 751 can prevent the marker from re-entering the side opening 742. When the cannula 740 is removed from the biopsy device or target set, the third ramp 747 can completely deflect any portion of the marker that may remain in the side opening 742 out of the side opening 742. . In addition to or in lieu of the foregoing, in an exemplary manner, composite ramp portion 746 was published on September 18, 2014 under the name “Biopsy Site Marker Applicator”. , US 2014/0276037, at least partly configured and operable, the disclosure of which is hereby incorporated by reference.

  The present invention has been disclosed in connection with a biopsy marker placement device. However, the various features and components disclosed in the drawings, like PEM, BSGI, and other imaging methods that can utilize radioisotopes or other radiation sources in connection with, for example, imaging a biopsy procedure, It can be used in devices useful for radioisotope applications.

  Although the device aspects disclosed herein are generally designed to be discarded after a single use, they may be designed to be used multiple times. After forming the marker and inserting the marker into the placer, for example, the biopsy device can be sterilized. The device can then be placed in a package such as a plastic or TYVEK bag.

  The packaged biopsy device can be placed in a radiation area such as gamma rays, x-rays or high energy electrons to sterilize the device and packaging. The device can be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

  While the aspects described herein have been described in connection with the aspects outlined above, various types of alternatives, modifications, variations, improvements, and / or substantial equivalents that are known or not currently anticipated. It will be appreciated by those having at least ordinary skill in the art. Accordingly, the foregoing exemplary aspects are intended to be illustrative and not limiting. Various changes can be made without departing from the spirit and scope of the invention. Accordingly, the disclosure herein is intended to embrace all known or later developed alternatives, modifications, variations, improvements and / or substantial equivalents.

  Accordingly, the claims are not intended to be limited to the aspects disclosed herein, but are to be given the full scope consistent with the language of the claims, and references to a single element And "only one" means "one or more" unless stated otherwise. All structural and functional equivalents for the various aspects of elements disclosed throughout this disclosure that are known to those skilled in the art or that are known in the future are hereby expressly incorporated by reference. Intended to be included within the scope of the claims. Furthermore, nothing disclosed herein is intended to be dedicated to the public regardless of whether the disclosure is expressly recited in the claims. Any claim element is to be interpreted as a means plus function unless explicitly stated using the phrase “means to do”.

  It is understood that the specific order or hierarchy of disclosed processes / flowcharts is illustrative of an exemplary approach. It should be understood that a particular order or hierarchy of processes / flow charts may be rearranged based on design preferences. Also, some features / steps may be combined or omitted. The accompanying method claims present elements of the various features / steps in the exemplary order, and are not meant to be limited to the specific order or hierarchy presented.

  Also, the word “example” is used herein to mean “provided as an example, instance, or illustration”. Any aspect described herein as "example" is not necessarily to be construed as preferred or advantageous over other aspects. Unless stated otherwise, the term “part” means one or more. Combinations such as “at least one of A, B, or C”, “at least one of A, B, and C” and “A, B, C, or any combination thereof” include A, B, and / or Or any combination of C, including multiples of A, multiples of B, or multiples of C. Specifically, combinations such as “at least one of A, B or C”, “at least one of A, B and C” and “A, B, C or any combination thereof” May be A only, B only, C only, A and B, A and C, B and C, or A and B and C, some combinations of which are one or more of A, B or C Of elements. The content disclosed herein is not intended to be dedicated to the public regardless of whether the disclosure is explicitly recited in the claims.

Claims (6)

  An instrument for inserting a marker into a tissue at a biopsy position,
    A long plunger with a blind bore formed inside,
    A plunger rod having a proximal end housed and secured within the blind bore and moving with the plunger;
    A long cannula having a lumen for receiving the distal end of the plunger rod;
    A stop member formed on the inner surface of the cannula near the distal end of the cannula;
  Have
  The cannula has a side opening through which the marker is ejected from the lumen of the cannula;
  The side opening is located distal to the stop member;
  The instrument further comprises:
    A ramp portion having a preselected inclined surface that is formed to communicate with the side opening and controls an angle of the marker emitted from the lumen; and
    A spring secured to the distal end of the plunger rod and extending axially relative to the plunger rod along a longitudinal axis defined by the plunger rod;
  Have
  With the plunger rod in contact with the proximal end of the spring, movement of the plunger rod from proximal to distal results in compression of the spring between the plunger rod and the marker, thereby A marker is passed through the stop member by the spring.
  A device characterized by that.   The instrument of claim 1, wherein the stop member is an annular crimp.   The instrument of claim 1, wherein the stop member is formed by at least two dimples formed in the cannula.   The instrument according to claim 3, wherein the at least two dimples are arranged at equal intervals and in a circumferentially spaced relationship.   The instrument of claim 4, wherein the at least two dimples include two dimples that are approximately 90 degrees apart from each other.   The instrument of claim 3, wherein the at least two dimples include between two and eight dimples.

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