KR20170093137A - Spring-ejected biopsy marker - Google Patents

Abstract

An apparatus for inserting a marker into a tissue at a biopsy site, comprising a long shaft moving together with the plunger and a joint secured to the distal end of the shaft. The device may include a cannula having a distal end of the shaft and having a crimp, dimple or other feature formed near the distal end of the shaft. The cannula may include a side opening through which the marker can be ejected from the lumen. The ramp portion may be configured to communicate with the side opening, and the ramp portion may include a pre-selected ramp that controls the angle at which the marker is ejected.

Description

{SPRING-EJECTED BIOPSY MARKER}

This application is related to U.S. Patent Application No. 14 / 534,952, filed November 6, 2014, entitled SPECT-EJECTED BIOPPS MARKER, and U.S. Application No. 62 / 134,715, filed March 18, 2015 , The invention is entitled "Biopsy Marker Delivery Device ", both of which are incorporated herein by reference in their entirety.

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

Biopsy samples were obtained in a variety of ways in various medical procedures using a variety of devices. The biopsy device can be used for stereotactic guidance, ultrasound guidance, magnetic resonance imaging (MRI) guidance, PEM (Positron Emission Mammography) induction, Breast Specific Gamma Imaging (BSGI) It can be used in other ways. For example, some biopsy devices can be fully manipulated with a single hand and single insertion by the user to obtain one or more biopsy samples from the patient. In addition, some biopsy devices may be connected to the vacuum module and / or the control module for fluid delivery (e.g., pressurized air, saline, atmospheric air, vacuum), power delivery, and / or communication. Other biopsy devices may be tethered or not fully connected to other devices and may be fully or at least partially operable.

Only exemplary biopsy devices and biopsy system components are described below. U.S. Patent No. 5,526,822 entitled " Method and Apparatus for Automated Biopsy and Collection of Soft Tissue "issued June 18, 1996; U.S. Patent No. 5,928,164 entitled " Apparatus for Automated Biopsy and Collection of Soft Tissues "issued July 27, 1999; U.S. Patent No. 6,017,316 entitled " Vacuum Control System and Method for Automated Biopsy Device "issued on January 25, 2000; U. S. Patent No. 6,086, 544 entitled " Control Apparatus for an Automated Surgical Biopsy Device "issued July 11, 2000; U. S. Patent No. 6,626, 849 entitled "MRI Compatible Surgical Biopsy Device ", issued Sep. 11, 2003; U.S. Patent No. 7,442,171 entitled " Remote Thumbwheel for a Surgical Biopsy Device "issued Oct. 8, 2008; U. S. Patent No. 7,648, 466 entitled " Manually Rotatable Piercer "issued Jan. 19, 2010; U.S. Patent No. 7,854,706 entitled " Clutch and Valving System for Tetherless Biopsy Device ", issued December 1, 2010; U.S. Patent No. 7,938,786 entitled " Vacuum Timing Algorithm for Biopsy Device "issued May 10, 2011; U.S. Patent No. 8,118,755 entitled " Biopsy Sample Storage ", issued Feb. 21, 2012; U.S. Patent No. 8,206,316 entitled " Tetherless Biopsy Device with Reusable Portion ", issued June 26, 2012; U.S. Patent No. 8,241,226 entitled " Biopsy Device with Rotatable Tissue Sample Holder ", published Aug. 14, 2011; And U.S. Patent No. 8,702,623 entitled " Biopsy Device with Discrete Tissue Chambers "issued April 22, 2014. Each disclosure of each of the above-cited US patents is incorporated herein by reference.

Other exemplary biopsy devices and biopsy system components are disclosed below. U.S. Published Patent Application No. 2008/0146962 entitled " Biopsy System with Vacuum Control Module "issued June 19, 2008; U.S. Published Patent Application No. 2008/0214955 entitled " Presentation of Biopsy Sample by Biopsy Device "issued Sep. 4, 2008; U.S. Publication No. 2013/0041256 entitled " Access Chamber and Markers for Biopsy Device "issued February 14, 2013; U.S. Patent Publication No. 2013/0053724 entitled " Biopsy Device Tissue Sample Holder with Bulk Chamber and Pathology Chamber "issued February 28, 2013; U.S. Patent Publication No. 2013/0150751 entitled " Biopsy Device with Slide-In Probe ", issued June 13, 2013; U.S. Published Patent Application No. 2013/0324882 entitled " Control for Biopsy Device "issued December 5, 2013; And U.S. Published Patent Application 2014/0039343 entitled " Biopsy System " issued February 6, Each disclosure of each of the above-cited U. S. patents is incorporated herein by reference.

In some circumstances it may be desirable to indicate the location of the biopsy site for future reference. For example, one or more markers may be deposited on the biopsy site before, during, or after the tissue sample is taken from the biopsy site. Examples of marker placement tools include MAMMOMARK ™ from Devicor Medical Products, Inc., Cincinnati, OH, MICROMARK? And CORMARK ™ brand devices. Other exemplary apparatus and methods for marking a biopsy site are described next. U.S. Published Patent Application 2009/0209854 entitled " Biopsy Method ", issued Aug. 20, 2009; U.S. Published Patent Application 2009/0270725 entitled " Devices Useful in Imaging ", issued October 29, 2009; U.S. Patent Publication No. 2010/0049084 entitled " Biopsy Marker Delivery Device ", issued February 25, 2010; U.S. Published Patent Application No. 2011/0071423 entitled " Flexible Biopsy Marker Delivery Device "issued March 24, 2011; U.S. Published Patent Application No. 2011/0071424 entitled " Biopsy Marker Delivery Device "issued March 24, 2011; U.S. Published Patent Application No. 2011/0071391 entitled " Biopsy Marker Delivery Device with Positioning Component "issued March 24, 2011; U. S. Patent No. 6,228, 055 entitled " Devices for Marking and Defining Particular Locations in Body Tissue "issued May 8, 2001; U. S. Patent No. 6,371, 904, entitled " Subcutaneous Cavity Marking Device and Method, " issued Apr. 16, 2002; U. S. Patent No. 6,993, 375 entitled " Tissue Site Markers for In Vivo Imaging "issued January 31, 2006; U.S. Patent No. 6,996,433 entitled " Imageable Biopsy Site Marker "issued February 7, 2006; U.S. Patent No. 7,044,957 entitled " Devices for Defining and Marking Tissue "issued May 16, 2006; U.S. Patent No. 7,047,063 entitled " Devices for Defining and Marking Tissue "issued May 16, 2006; U.S. Patent No. 7,229,417 entitled " Methods for Marking a Biopsy Site ", issued June 12, 2007; And US Patent No. 7,465,279 entitled " Marker Device and Method of Deploying a Cavity Marker Using a Surgical Biopsy Device "issued December 16, 2008 . The disclosures of each of the above-cited US patents and US patents are incorporated herein by reference.

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

Additional advantages and novel features of these aspects will be set forth in part in the description that follows, and in part will become more apparent to those skilled in the art upon examination of the practice of the invention or upon learning by those skilled in the art.

1 is a perspective view of an exemplary marker delivery device, in accordance with aspects of the present invention.
Fig. 2 shows a cross-sectional view of the distal end of the marker delivery device of Fig. 1 for a cross-section taken along line 2-2 of Fig.
FIG. 3A is a side elevational view of the distal end of the shaft of the marker delivery device of FIG. 1;
Figure 3b is a partial cross-sectional view of the distal end of the marker delivery device of Figure 1, with the shaft and spring in an initial proximal position.
3C is a partial cross-sectional view of the distal end of the marker delivery device of FIG. 1, with a partially advanced distal shaft and spring.
Figure 3d is a partial cross-sectional view of the distal end of the marker delivery device of Figure 1, with a fully advanced shaft and spring in the distal direction.
4 is a cross-sectional view of the cannula of the marker delivery device of FIG. 1 for a cross-section taken along line 4-4 of FIG. 2;
Figure 5 is a perspective view of an exemplary marker for use with the marker delivery device of Figure 1;
6 is a perspective view of another exemplary marker for use with the marker delivery device of FIG.
Figure 7 is a perspective view of another exemplary marker for use with the marker delivery device of Figure 1;
Figure 8 is a perspective view of another exemplary cannula for use with the marker delivery device of Figure 1;
Figure 9 is a cross-sectional view of the cannula of Figure 8 taken along line 9-9 of Figure 8;
10 is a perspective view of another exemplary marker delivery device in accordance with aspects of the present invention.
11A is a side view of the marker delivery device of FIG. 9, with the plunger in the inoperative position.
FIG. 11B is another side view of the marker delivery device of FIG. 9, with the plunger in a partially actuated position.
Figure 11C is another side view of the marker delivery device of Figure 9, with the plunger in its fully operative position.
Figure 12 is a perspective view of another exemplary marker delivery device in accordance with an aspect of the present invention.
13 is a cross-sectional view of the marker delivery device of FIG. 12, taken along line 13-13 in FIG. 12;
Figure 14 shows the distal end of the cannula of the marker delivery device of Figure 12;
Figure 15 is a perspective view of another exemplary cannula for use with the marker delivery device of Figure 1;
Figure 16 is a cross-sectional view of the cannula of Figure 15 taken along line 16-16 of Figure 15;
17A is a side view of one of various features of an exemplary apparatus having a rupture portion that indicates that the length of the structure may be a preselected length, in accordance with aspects of the present invention.
FIG. 17B is a longitudinal sectional view taken along line 1B-1B of FIG. 17A. FIG.
17C is an enlarged view of the distal end portion of the structure frame shown in Fig. 17B.
Figure 17d shows another aspect in which the dimple replaces the annular crimp of Figure 1a.
Figure 18A schematically shows a side view of the device.
FIG. 18B is a longitudinal side sectional view of the structure shown in FIG. 18A. FIG.
Figure 18c shows a top plan view of the structure shown in Figure 18a.
Figure 19 is a side view of various features of an exemplary device in accordance with 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, modifications, and advantages of the techniques will become apparent to those skilled in the art from the following description, which is one of the best modes contemplated for carrying out the techniques. As will be appreciated, aspects of the present invention are capable of other distinct and obvious implementations without departing from the specification. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

1 to 4 illustrate a marker delivery device 10 that can be used with a biopsy device or a target set to deliver a marker to a biopsy site. The marker delivery device 10 includes a body 20 and a cannula 40. The body 20 includes an elongate housing 22, a grip 24, an elastic member 26 and a plunger 28, as shown in Fig. The housing 22 connects the body 20 to the delivery cannula 40. The housing 22 may also surround other operating components of the marker delivery device 10, such as a seal, spring, bushing, or other actuation component, which may be apparent to those skilled in the art in view of the teachings herein have.

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 will be described in greater detail below, the grip 24 is generally configured such that the marker delivery device 10 can be operated with one hand of the user. The grip 24 of the present example is formed integrally with the housing 22. In other instances, the grip 24 may be detached from the housing 22 instead.

The elastic member 26 is disposed between the grip 24 and the plunger 28. In particular, the resilient member 26 of the present example includes leaf springs having two openings 27 at either end of the resilient member 26. The opening 27 is configured to receive the shaft 30 slidably. The shaft 30 is slidable relative to the body 10 to selectively eject the marker 60 from the marker delivery device 10. [ While the resilient member 26 is shown as a leaf spring, it should be appreciated that in other embodiments any suitable resilient mechanism, such as a coil spring, may be used.

The plunger 28 is located at the proximal end of the shaft 30. Generally, the plunger 28 is configured to be pushed by the user to actuate the shaft 30 on the circle against the body 20 and the cannula 40. 1, the plunger 28 is in contact with the elastic member 26 so that even after the user actuates the marker transmission device through the plunger 28, The shaft 30 can be returned to the proximal position. The plunger 28 and grip 24 are configured together to allow the user to grip the grip 24 with two fingers (e.g., index finger and stop) and with another finger (e.g., a thumb) to engage the plunger 28 ). Although not shown, the plunger 28 may include a plunger lock or other locking feature to allow a user to ratchet or lock the plunger 28 in place (e.g., in a proximal position To lock the plunger 28 and / or to lock the plunger 28 in the distal position). Suitable locking features may include an elastic latching arm, a bayonet latching feature, a threaded feature, and the like.

The cannula 40 is comprised of a tubular shaft extending in a distal direction from the housing 22. In general, the cannula 40 extends in a distal direction by a length suitable for insertion into the biopsy device or target set so as to extend to the biopsy site to deliver the marker 60. In this embodiment, the distal end of the 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 understood, the specific position of the side opening 42 with respect to the distal end of the cannula 40 is configured such that the side opening 42 can be aligned with the corresponding lateral opening of the needle of the biometric device .

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. As shown in FIG. The proximal end of the distal tip 44 includes a ramp portion 46. The ramp portion 46 extends from the cannula lumen 48 extending longitudinally through the cannula 40 and in communication with the side opening 42 as shown in greater detail below .

The cannula lumen 48 extends from the proximal end of the cannula 40 to the distal end of the cannula 40. Although not shown in FIG. 2, it should be appreciated that in some embodiments, the cannula lumen 48 may extend into the housing 22 so that the shaft 30 of the body 20 can communicate with the lumen. In particular, as shown in FIG. 2, the shaft 30 extends fully into the cannula 40 through the body 20 before terminating near the distal end of the cannula 40. The shaft 30 is engaged with the marker 60 to allow the marker 60 to slide over the ramp portion 46 and out of the side opening 42 while sliding within the cannula lumen 48, It is easily deployed. In some aspects, the slope of the ramp portion 46 may control the angle at which the marker 60 is ejected from the lumen of the cannula 48.

The shaft 30 of the present embodiment is shown coaxially disposed within the cannula lumen 48 but in other embodiments the shaft 30 terminates within the body 20 and the other member, May extend into the cannula lumen (48).

According to some embodiments of the present invention, as shown in FIG. 17A, the device may include a plunger 172 having an enlarged proximal end 171 that may serve as a handle for a user, for example. 17B, the proximal end 173a of the elongate shaft 16 may be received within a bore 172a formed by the plunger 172, and the shaft 173 may be received within the bore 172a with the plunger 172 And can be fixed to the shaft so as to be movable.

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

As shown in Figure 3A, the distal end of shaft 30 of the present example includes a spring 90 that extends over at least a portion of the distal end of shaft 30. In particular, the spring 90 of the present embodiment includes a multi-pitch coil spring that is coaxial with at least a portion of the shaft 30, for example, a force of 1.9 to 2.4 pounds per lb. Respectively. In this embodiment, the spring 90 is constructed of biocompatible stainless steel, but 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 are formed at substantially the same pitch. It should be understood that the term "pitch ", as used herein, generally refers to the spacing between each coil of the spring 90. For example, the pitch of the first pitch region and the pitch of the third pitch region 96 may be relatively small relative to the pitch of the second pitch region 94. The term "pitch" may also be understood to relate to a specific number of coils per axial distance unit (e.g., coils per inch).

The spacing between the respective coils of the springs 90 of the first pitch region 92 and the third pitch region 96 of the present example may be relatively small or approximately zero so that the first pitch region 92 and the third pitch region 96, Each of the coils in the region region 96 is in contact or almost in contact with each other. As will be described later, this pitch causes very little compression of the first pitch region 92 and the third pitch region 96 when the spring 90 is compressed. However, as compared to the compacted spacing between the respective coils of the springs 90 of the first pitch region 92 and the third pitch region 96, each coil of the spring 90 of the second pitch region 94 Is relatively large. Thus, when the spring 90 is compressed, the second pitch region 94 can be much more compressed with respect to the first pitch region 92 and the third pitch region 96. Although it is shown that the pitch regions 92, 94, 96 have a certain pitch, it should be understood that each pitch region may have any other suitable pitch, as will be apparent to those skilled in the art in light of the teachings herein.

Although the first pitch region 92 and the third pitch region 96 may include any suitable number of coils, the first pitch region 92 and the third pitch region 96 of the present embodiment are 24 to < RTI ID = 0.0 > Includes 25 coils. The first pitch region 92 and the third pitch region 96 are configured so that they are hardly compressed relative to the second pitch region 94 when the spring 90 is compressed, The three pitch region 96 may still be configured to bend in the lateral direction and the shaft 30 may be in contact with the marker 60 through the spring 90 while being in contact with the marker 60, Exercise can still be shown. Also, 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, during operation of the plunger 28, When subjected to a compressive load, the second pitch region 94 may be compressed before the first and third pitch regions 92, 96.

According to some embodiments of the present 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 embodiments, the coils may be tightly packed against one another at the distal end of the spring of the pitch region 175c. According to some embodiments, the proximal pitch region 175b may comprise loosely packed coils. As will be described below, it should be appreciated that a spring having two pitch regions may function similarly to a spring having three pitch regions.

3A, the spring 90 is generally fixedly secured to the shaft 30 such that the spring 90 first contacts the marker 60 and the shaft 30 is advanced So that the shaft 30 can eventually contact the marker 60. The spring 90 is shown fixedly attached to the shaft 30 at a point adjacent the distal end of the shaft 30 and a portion of the first pitch region 92 is located distal of the shaft 30, Extends in the distal direction from the end. Of course, in other instances, any suitable portion of the spring 90 may extend from the distal end of the shaft 30. The spring 90 of the present embodiment can be fixedly fixed to the shaft 30 by, for example, laser welding. In another example, the shaft 30 may include an annular projection or a plurality of protrusions that may simply prevent the spring 90 from sliding in a proximal direction along the shaft 30. In another example, the shaft 30 may include an annular protrusion or a plurality of protrusions that may be configured to secure the spring 90 through a press or interference fit. In another example, other suitable features or methods for securing the spring 90 to the shaft 30 may be used, such as screws, fins, or adhesives, etc., as will be apparent to those skilled in the art in light of the teachings herein.

17B, the apparatus may include an annular detent 175a weld formed integrally with the shaft 173, and may be provided on the shaft 173 such that the spring does not slide 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 can be generally cylindrical and can be composed of collagen, hydrogel, and / or any other suitable material. The reabsorbable body 62 includes a metallic (e.g., titanium), generally radiopaque, marker element 64 disposed in the reabsorbent body 62 or loaded on the reabsorbent body 62 ). ≪ / RTI > It should be noted that the marker element 64 of this embodiment is formed of a coil spring, but the marker element 64 may have any other shape suitable to improve radiographic visibility. It should also be appreciated that the metal is only a mere example of one kind of material that can be used to form the marker element 64. Various other suitable materials that may be used will be apparent to those skilled in the art in view of the teachings herein.

In some cases, it may be desirable to provide a marker retention feature on the marker delivery device 10 for selectively securing the marker 60 within the cannula 40. For example, the cannula 40 of the present embodiment includes two retaining dimples 50 disposed in the cannula lumen 48 proximal of the side opening 42. As best seen in FIG. 4, the dimples 50 may be disposed near the bottom of the cannula 40 at a distance from the side opening 42. The dimples 50 may be hemispherical in shape, for example, and project into the cannula lumen 48. Accordingly, the dimple 50 can be configured as a stop member for engaging at least a portion of the marker 60 to retain the marker 60 in the cannula lumen 48. However, since the resilient body 62 is comprised of collagen, hydrogel, and / or other deformable material, the marker 60 has a relatively elastic nature such that it is selectively constrained past the dimple 50 by the shaft 30 Lt; / RTI > Alternatively, the marker 60 may be smaller than the inner diameter of the cannula 40 such that the marker 60 can be pushed over the dimple 50 and upward when the shaft 30 is pushed by the shaft 30. Although the cannula 40 is shown as including two dimples 50, it should be appreciated that in another example, the cannula 40 may comprise any other suitable number of dimples 50.

17D, two circumferentially spaced dimples 174d may be formed in the cannula 174. As shown in Fig. 17D, defining a top, such as a lateral opening of the cannula 174, at a 0 degree position, the first dimple may be positioned at approximately 135 degrees (135 degrees), and the second dimple May be positioned at approximately 225 degrees (225 degrees). That is, at the same circumferential offset from the side opening. According to some aspects, the annular crimp 174a may be formed by a large number of closely spaced dimples. However, the desired number of circumferentially spaced dimples at even intervals may be at least two, or at least eight, as shown. According to some aspects, for example, if eight dimples are selected, there can be one dimple at a 0 degree position, then one per 45 degrees (45 degrees) around the cannula 174 May be present.

Additionally or alternatively, the dimples 50 may include other shapes than hemispherical. For example, the dimples 50 may be pyramidal, cuboidal, rhombic, or any other suitable shape, which will be apparent to those skilled in the art in light of the teachings herein. As yet another illustrative example, protrusions, such as annular projections or crimps, may extend circumferentially inside the lumen 48 as an alternative to the dimple 50. A relatively flexible and resilient flap or tab of an integral construction with a cannula 40 is another alternative for dimple 50 and may include a lumen 48 inside .

18A-C, the cannula 174 may include a flap 177, which is not visible in the side elevation view of FIG. 18A, Side sectional view and a longitudinal plan view of 18c. According to some aspects, the flap 177 and the cannula 174 can be integrally formed with each other, for example, the flap provides a detent, For example, the flap 177 can perform a function similar to the annular crimp or dimple described herein. According to some aspects, this flap 177 may be used when the marker 176 is formed of a material that is both flexible and resilient.

19, a bulge or protrusion 26 may be formed in the lumen of the cannula 174 and such a bulge may have a similar function to the flap 177 Can be performed. For example, the projection 178 and the flap 177 can be configured so that a rigid marker 176 is flattened when pushed over these features.

Figs. 3B to 3d show examples of the use of the marker delivery device 10. Fig. As can be seen in FIG. 3B, the marker 60 is initially disposed within the cannula lumen 42 proximate the dimple 50. The user can insert the cannula 40 into the biopsy device or target set to deliver the marker 60 to the biopsy site, together with the biopsy device or target set already located in the tissue of the biopsy site. The cannula 40 can be positioned such that the side opening 42 is angularly and longitudinally aligned with the complementary lateral opening of the needle or cannula of the biopsy device or target set. For example, once the cannula 40 is inserted into the biopsy device or target set and properly positioned, the user can begin placement by holding the grip 24 and pressing the plunger 28 with one hand or the other.

When the plunger 28 is urged into the distal end, the shaft 30 can be advanced in the distal direction with respect to the cannula 40 and the body 20, as shown in FIG. 3B and FIG. As the distal end of the shaft 30 approaches the marker 60, the spring 90 may initially contact the marker 60. As shown in Figs. 3B and 3C, this contact compresses the spring 90 as the shaft 30 further advances to store the position energy within the spring 90. Fig.

Further advancement of the shaft 30 may result in direct contact between the marker 60 and the distal end of the shaft 30. [ 3C, the distal end of the shaft 30 may be generally aligned with the distal end of the spring 90 at this stage. When this direct contact is initiated, the shaft 30 begins to push the marker 60 in the cannula 40, thereby pushing and / or traversing the dimple 50 and beyond the distal opening 60 ). If the marker 60 is at the end of the dimple 50, the spring 90 may begin to expand through the potential energy generated during compression of the spring 90. The expansion of this spring 90 causes the marker 60 to laterally advance over the ramp portion 46 of the distal tip 44 to advance outward through the side opening 42 and to move the marker 60 outwardly As shown in FIG. It should be appreciated that the first pitch region 92 may be bent over the dimple 50 and extend beyond the dimple 50. Thus, for example, the configuration of the spring 90 may be such that the spring 90 is positioned within the lumen 48 such that it can move beyond the dimple 50 without requiring any lateral deflection of the shaft 30 within the lumen. So that the spring 90 can be deflected in the lateral direction. The coils forming the first pitch region 92 are merely capable of sliding relative to one another to pass through the dimple 50. In an alternative embodiment in which the dimples are arranged in a larger angular range within the lumen 48 (e.g., as in the cannula 640 described below), the spring 90 still extends beyond the dimple 50 It can be deformed to pass far. For example, the coils forming the first pitch region 92 may slide and tilt relative to one another about the longitudinal axis of the lumen 48 to reduce the effective outer diameter of the spring 90, So as to pass through the space formed between them.

Figure 5 illustrates an exemplary other marker 160 that may be used in addition to or in place of the marker 60 as described above. The marker 160 of this example is substantially similar to the marker 60. For example, as with the marker 60, the marker 160 may include a biodegradable or resorbable body 162. The resorbable body 162 can be generally cylindrical and can be composed of collagen, hydrogel, and / or any other suitable material. Like the reabsorbable body 62, the reabsorbable body 162 includes a metallic, generally radiopaque, marker element 164 (not shown) disposed within the reabsorbable body 162 or carried by the reabsorbable body 162 ). However, unlike the marker element 64, the marker element 164 of the present example includes a disc-shaped center 166 having three elongated protrusions 168 radially outwardly from the central member 166 and projecting out of the reabsorbable body 162, Member 166 (shown in phantom). It should also be appreciated that the metal is merely an example of one type of material that can be used to form the marker element 164. Various other suitable materials that may be used will be apparent to those skilled in the art in view of the teachings herein.

In some instances, a long protrusion 168 may project radially outward from the central member 166 to provide friction against the interior of the cannula 40. Thus, for example, the long protrusion 168 may be configured to contact the interior of the cannula 40. It is contemplated that such a configuration may be used in conjunction with or instead of the dimple 50 to retain the marker 160 in the cannula 40 to prevent the marker 160 from accidentally falling off the cannula 40, . In addition, the long protrusions 168 may engage the tissue at the biopsy site to prevent movement of the marker 160 by securing the marker 160 to the biopsy site.

Figure 6 illustrates another exemplary marker 260 that may be used in addition to or in place of the marker 60 as described above. The marker 260 of this example may be substantially similar to the marker 60. [ For example, as with the marker 60, the marker 260 may include a biodegradable or reabsorbable body 262. However, unlike the reabsorbable body 62, the reabsorbable body 262 may comprise a hybrid of at least two materials. For example, the reabsorbable body 262 of the present embodiment may include a generally cylindrical collagen intermediate portion 261, two hydrogel intermediate portions 263, and two collagen distal ends 265. Like the reabsorbable body 62 described above, the reabsorbable body 262 includes a metallic, generally radiopaque, marker element 264 (shown in phantom in a dashed line) disposed or disposed in the reabsorbable body 262, Lt; / RTI > However, unlike the marker element 64, the marker element 264 of the present example may be a rectangle having a generally centered twist 266 such that it is configured to improve the radiation visibility of the marker element 264. It should also be understood that the metal is merely a mere example of a material that can be used to form the marker element 264. [ Various other suitable materials that may be used will be apparent to those skilled in the art in view of the teachings herein.

Figure 7 illustrates another exemplary marker 360 that may be used in addition to or in place of the marker 60 as described above. The marker 360 of this example may be substantially similar to the marker 60. [ For example, as with the marker 60, the marker 360 may include a biodegradable or other reabsorbable body 362. However, unlike the reabsorbable body 62, the reabsorbable body 362 may comprise a hybrid of at least two materials. For example, the reabsorbable body 362 of the present embodiment may include a generally cylindrical collagen outer shell 361 having a hydrogel-internal core 363. Like the reabsorbable body 62 described above, the reabsorbable body 362 can include a metallic, generally radiopaque, marker element 364 that is disposed within the reabsorbable body 362 or carried in a different manner. have. However, unlike the marker element 64, the marker element 364 of the present example may be a rectangle with a generally centered twist 366 configured to enhance the radiation visibility of the marker element 364. [ It should also be understood that the metal is merely a mere example of a kind of material that can be used to form the marker element 364. [ Various other suitable materials that may be used will be apparent to those skilled in the art in view of the teachings herein.

Figures 8 and 9 illustrate an exemplary alternative cannula 440 that may be incorporated into the biopsy marker device 10 described above. The cannula 440 of the present embodiment may be substantially similar to the cannula 40 described above unless otherwise stated herein. The cannula 440 includes a long tubular shaft 441 that includes a proximal lateral opening 442 of the distal tip 444 and a cannula lumen 448 extending through the cannula 440 . However, unlike the cannula 40, the cannula 440 may include a sheath 452 in the form of a sleeve disposed over at least a portion of the distal tip of the cannula 440. [ It should also be understood that the metal is merely a mere example of a material that can be used to form the envelope 452. Various other suitable materials that may be used will be apparent to those skilled in the art in view of the teachings herein. Metal sheath 452 may be configured to provide structural reinforcement at the distal end of cannula 440. For example, the metal sheath 452 may prevent the distal end of the cannula 440 from buckling or otherwise deforming during use of the cannula 440. Additionally or alternatively, when the cannula 440 is formed of a material of a lower hardness than the metal sheath 452, the metal sheath 452 may be shaped such that the material of the cannula 440, which is relatively flexible or resilient, (Scraped or shaven) by the edges that make up the edge. The cannula 440 is inserted into the side opening of the biopsy needle.

The side openings 442 of the present embodiment may be incorporated into both the cannula 440 and the metal shell 452. The side openings 442 are angled at an angle to the cannula 440 so that the cannula 440 and the metal sheath 452 are aligned together to form a beveled edge 445, 454, 456, And the metal shell 452. [0053] For example, the metal sheath 452 may include a distal beveled edge 454 and a proximal beveled edge 456. The distal ramp edge 454 of the metal shell 452 may be aligned with the ramp portion 446 of the distal tip 444 and the distal ramp edge 454 and ramp portion 446 may be aligned at substantially similar angles . Similarly, the proximal beveled edge 456 of the metal shell 452 may be aligned with the beveled proximal edge 445 of the cannula, and the two proximal edges 445, 456 are oriented at substantially similar angles.

The sloped edges 445,454 and 456 and the ramp portion 446 may be used to reduce the trauma to the tissue while still retaining the lateral opening 442 with a dimension large enough for the markers 60,602, As shown in Fig. In this embodiment, the tilt angle of the distal tapered edge 454 and the ramp portion 446 is steep compared to the tilt angle of the proximal tapered edges 456, 445. Although the specific relationship between the distal tapered edge 454 and the ramp portion 446 and the proximal tapered edges 445 and 456 is shown, no limitation to the illustrated example is intended, and in each of the other examples, And may be altered as will be understood by those skilled in the art in light of the teachings herein.

As shown in FIG. 9, the distal tip 444 of the present example is integral with the shaft 441. The distal tip 444 and the shaft 441 may be configured to receive the metal sheath 452 such that the metal sheath 452 supports the distal tip 444. In some variations, for example, the distal tip 444 and the shaft 441 may be injection molded into the metal shell 452 such that the metal shell 452 is overmolded by the distal tip 444 and / And can be attached to the shaft 441. In another example, the metal shell 452 may be simply attached to the distal tip 444 and the shaft 441 by adhesive bonding, mechanical fastening or any other suitable fastening method.

The metal shell 452 of the present embodiment includes a metallic biocompatible material such as stainless steel, titanium, and / or any other suitable metal. However, no limitations on these examples are intended. For example, in another example, the metal shell 452 may include a relatively dense plastic relative to the shaft 441 and the distal tip 444. In another example, the metal shell 452 may comprise a ceramic material. In another example, metal shell 452 may be made of any other suitable material, as will be apparent to those skilled in the art.

Figs. 10-11c illustrate another exemplary marker delivery device 510 that is similar to the marker delivery device 10 described above. For example, the marker delivery device 510 may include a body 520 and a cannula 540. The body 520 may include a long housing 522, a grip 524, and a plunger 528. The housing 522 may be substantially similar to the housing 22 described above. However, unlike the housing 22, the housing 522 of the present embodiment may include additional components configured to provide multiple operating positions for the plunger 528, as will be described in greater detail below.

Similar to the plunger 28 described above, the plunger 528 of the present embodiment can be located at the proximal end of the shaft 530 extending longitudinally through the body 520 and the cannula 540. Also similar to the plunger 28 described above, for example, the plunger 528 of the present example can be used with the grip 524 for operation with one hand of the marker delivery device 510. 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 similar to the cannula 40 described above and may comprise a long tubular shaft extending in a distal direction from the housing 522. In general, the cannula 540 is configured to transmit any one of the markers 60, 160, 260, 360 described herein through a lateral opening 542 near the distal end of the cannula 540. [ The cannula 540 may extend in the distal direction by a length suitable for insertion into the biopsy device or target set.

FIGS. 11A-C illustrate exemplary operating modes of the marker delivery device 510. FIG. As can be seen in Fig. 11A, the plunger 528 of the body 520 initially begins at the 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 is located in the side opening 542 of the cannula 540 at the biopsy site, for example, The side openings 542 may be aligned to form longitudinal and predetermined angles with similar side openings of the biopsy device or target set.

Once the marker delivery device 510 is positioned within the biopsy device or target set, the user may wish to place the markers 60, 160, 260, 360 on the biopsy site. To position the markers 60, 160, 260, 360, the user may advance the plunger 528 to a partially actuated position, as shown in FIG. 11B. In this embodiment, the housing 522 includes a shaft 530 for ejecting the markers 60, 160, 260, 360 from the side opening 542 when the plunger 528 is advanced to the partially actuated position. As shown in FIG.

In some cases, it may be desirable to rotate the cannula 540 within the biopsy device or target set after placement of the markers 60, 160, 260, 360. For example, after the positioning of the markers 60, 160, 260, 360, the markers 60, 160, 260, 360 may cause at least a portion of the markers 60, 160, 260, 360 back to the side openings 542 And can be held close to the side opening 542 of the cannula 540 so as to be able to enter. In this case, removal of the marker delivery device 510 may be prevented by removing the markers 60, 160, 260, and 360 because the markers 60, 160, 260, 360 may be caught between the side openings 542 and the corresponding side openings of the biometric device or target set. 360 may be damaged. Thus, the marker delivery device 510 can be positioned within the cannula 540 (e.g., without the marker 60, 160, 260, 360) positioned between the side opening 542 and the corresponding side opening of the biometric device or target set May be configured to selectively rotate the cannula 540 to facilitate removal of the cannula 540.

The plunger 528 is advanced to a fully actuated position to initiate rotation of the cannula 540 relative to the body 520. As shown in FIG. It should be noted that to achieve this function, the interior of the housing 522 may include other mechanical devices that can be assembled to effect rotation of springs, levers, gears, cams, or cannulas 540. [ The various components and features that may be used to provide such rotation of the cannula 540 relative to the body 520 in response to the complete advancement of the plunger 528 relative to the body 520 are well within the scope of the teachings herein, . The components in this example, the housing 522 may include, for example, to be understood that the cannula 540 about the body (520), 180 ^o may be configured to rotate. In another example, the housing 522 may be configured to rotate the canula 540 at any suitable angle relative to the body. By way of example only, the housing 522 may be configured to rotate the canula 540 at 90 ^o , 270 ^o, or any other suitable radial distance.

For example, if the plunger 528 advances to the fully operative position to rotate the cannula 540, the marker delivery device 510 may be removed from the biopsy device or target set. Alternatively, in some embodiments, the marker delivery device 510 may be configured to arrange a plurality of markers 60, 160, 260, 360. In this example, the housing 522 can optionally be configured to return the cannula 540 to its original position for placement of another marker 60, 160, 260, 360 upon retraction of the plunger 528 have. The sequence described above can be restarted. Although the sequence described above has been described as including two separate advances of the plunger 528 by the user, it should be appreciated that in another example, the plunger 528 may optionally be advanced to a single stroke. In this example, among other things, the markers 60, 160, 260, 360 may be placed and then the cannula 540 may be rotated immediately.

12-14 illustrate another exemplary marker delivery device 610 that is similar to the marker delivery device 10 described above. For example, the marker delivery device 610 may include a body 620 and a cannula 640. The body 620 may include an elongate housing 622, a grip 624, and a plunger 628. The housing 622, the grip 624 and the plunger 628 may be substantially similar to the housing 22, grip 24 and plunger 28 described above, so that at this point in the description, Lt; / RTI > will not be repeatedly described.

The cannula 640 may be substantially similar to the cannula 40 described above in that the cannula 640 may be comprised of an elongated tubular shaft extending in a distal direction from the housing 522. Generally, as shown in Figures 12-14, the cannula 640 may extend to the biopsy site and be inserted into a biopsy device or device to deliver one of the markers 60 (60, 160, 260, 360) Extends in the distal direction by a length suitable for insertion into the target set. However, unlike the cannula 40, the cannula 640 of the present example has no side opening. Alternatively, the cannula 640 may include an open distal tip 644 that communicates with a cannula lumen 648 that extends through the cannula 640, for example. Thus, the cannula 640 can be configured to position the marker 60 longitudinally through the open distal tip 644.

13 and 14, the cannula 640 may further include a plurality of dimples 650 similar to the dimples 50 of the cannula 40. As shown in FIG. For example, the dimples 650 can be configured to selectively hold the markers 60 within the cannula 240 in general. The dimples 650 may include a hemispherical shape that is substantially similar to the dimples 50 described above. However, unlike the cannula 40 as described above, the cannula 640 of the present example may include three dimples 650. As shown in FIG. 14, the dimples 650 may be equidistantly disposed about the inner diameter of the cannula 640. As with the dimples 50 described above, the dimples 650 of this embodiment may be formed by any other suitable shape and / or configuration, as will be appreciated by those skilled in the art in view of the teachings of the present invention. And the like.

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

It should be noted that, in some instances, at least a portion of the side opening 742 (e.g., the distal portion of the side opening 742) may also be made slightly smaller than the side opening 42 described above. This sizing may allow side openings 742, for example, to accommodate smaller markers.

The cannula 740 may also be different from the cannula 40 in that the distal tip 744 may include a composite ramp portion 746, as shown in FIG. For example, the distal tip 744 may include three separate ramp portions 743, 745, 747 and two relatively flat portions 749, 751. Although the particular angle of each ramp portion 743, 745, 747 may be varied in other embodiments, the ramp portions 743, 745, 747 are shown sloping at similar angles in Fig. In general, the ramp portions 743,745, and 747 may be configured to progressively deflect a marker (not shown) through the side opening 742. [ This gradual step may be desirable in order to prevent the marker from prematurely escaping the cannula 40 after the marker has been delivered to the biopsy site and to prevent the marker from entering the side opening 742 again.

The flat portions 749 and 751 may be generally parallel along a flat plane with respect to the longitudinal axis of the cannula 740, for example. As the marker moves from the ramp portions 743, 745 and 474 to the ramp portions 743,745 and 747 the flat portions 749 and 751 provide the spacing between the ramp portions 743,745 and 474, Lt; / RTI > For example, in an exemplary use, the marker may first ascend above the first ramp portion 743 as the marker advances in the distal direction. The first ramp portion 743 can provide some resistance to the distal movement of the marker. By way of example only, the first ramp portion 743 is constructed according to at least a portion of the description of U.S. Patent No. 8,532,747 entitled " Biopsy Marker Delivery Device " issued September 10, 2013 Which is incorporated herein by reference.

Once the marker has passed through the first ramp portion 743 the marker moves along the first flat portion 749 and the second ramp portion 745 at an angle generally parallel to the angle of the second ramp portion 745, You can climb up. The second ramp portion 745 may provide a cam surface to eject 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 portion 747 completely deflects any portion of the marker that may remain in the side opening 742 out of the side opening 742 deflect. In addition to or instead of the foregoing, in an exemplary manner, the composite ramp portion 746 may be formed from a composite lamp portion 746, such as that disclosed in U. S. Patent < RTI ID = 0.0 >Lt; RTI ID = 0.0 > 2014/0276037, < / RTI > the disclosure of which is incorporated herein by reference.

The present invention has been described in the context of a biopsy marker placement device. It should be understood, however, that the various features and elements described in the drawings are not intended to limit the scope of the present invention to the applications of radioisotopes, such as PEM, BSGI and other imaging methods that may utilize radioactive isotopes or other radiation sources, Can be used in useful devices.

Aspects of the devices disclosed herein are generally designed to be discarded after a single use, but may also be designed for multiple uses. After the marker is formed and the marker is inserted into the locator, the biopsy device can be sterilized, for example. The device can then be placed in a package such as a plastic or TYVEK bag.

The packaged biopsy device may be placed in an irradiated area, such as gamma, X-ray or high energy electron, to sterilize the device and the packaging. The device may be sterilized using any other technique known in the art, including, but not limited to, beta or gamma rays, ethylene oxide, or steam.

Although the embodiments described herein have been described in connection with the above-described aspects, it will be appreciated that various alternatives, modifications, variations, improvements and / or substantial equivalents of the known or unexpectedly presently contemplated, It is natural for those with skills. Accordingly, the foregoing exemplary aspects are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the invention. Accordingly, the present disclosure 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, and the full scope of equivalents to the language of the claims should be given, and reference to the singular elements is not intended to be "one and only one & Unless mentioned, it means "more than one". All structural and functional equivalents to the elements of the various aspects described throughout this disclosure which will be known or later disclosed to those skilled in the art are expressly incorporated herein by reference, Are intended to be included in the scope. Further, nothing disclosed herein is intended to be dedicated to the public, whether or not such disclosure is expressly set forth in the claims. Any claim element should be interpreted as a means plus function unless expressly stated to the contrary by using the phrase "means for ".

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

Also, the word "for example" is used herein to mean "serving as an example, instance, or illustration. &Quot; Any aspect described herein as "for example" is not necessarily to be construed as preferred or advantageous over other aspects. Unless otherwise indicated, the term "part" means one or more. A combination 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" means any combination of A, B and / And may include a multiple of A, a multiple of B, or a multiple of C. Specifically, a combination 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" And may be A and B, A and C, B and C, or A and B and C, any combination of which may include one or more elements or elements of A, B or C. The disclosure herein is not intended to be dedicated to the public regardless of whether such disclosure is expressly referred to in the claims.

Claims (20)

A tube having a first end and a side opening;
At least one biopsy marker positioned proximal to the side opening;
A push rod having a first end at least partially disposed within the tube, the push rod being movable in a direction toward the first end thereof to engage the at least one biopsy marker; And
Wherein the push rod extends from the first end of the push rod and engages the at least one biopsy marker when the push rod is moved in a direction toward the first end thereof to urge the at least one biopsy marker An elastic member configured to drive through the side opening
. The method according to claim 1,
Wherein the tube comprises a protrusion extending radially inward. 3. The method of claim 2,
Wherein the inwardly projecting portion is located adjacent the side opening. 3. The method of claim 2,
Wherein the inwardly extending protrusion comprises an annular protrusion. 3. The method of claim 2,
Wherein the inwardly extending protrusion comprises at least two dimples. 3. The method of claim 2,
Wherein the inwardly extending protrusion comprises a flap. The method according to claim 1,
And a tip inserted into the first end of the tube. 8. The method of claim 7,
Wherein the tip comprises a ramp portion. 9. The method of claim 8,
The lamp unit includes:
Wherein the biopsy marker has a preselected sloped surface indicating an angle at which the biopsy marker is ejected from the tube. The method according to claim 1,
Wherein the elastic member comprises a spring. 11. The method of claim 10,
The spring
At least a first pitch region and a second pitch region,
Wherein the coils of the first pitch region are packed tightly than the second pitch region. The method according to claim 1,
Wherein the biopsy marker comprises a resorbable body. The method according to claim 1,
Wherein the biopsy marker comprises a deformable material. A tube having a first end, the first end including an opening and a plurality of stationary members disposed proximal to the opening;
At least one biopsy marker positioned proximal to the plurality of stop members of the tube; And
A push rod having a first end that is at least partially disposed within the tube, the push rod being moveable in a direction toward the first end of the push rod, the push rod passing through the opening of the tube past the plurality of stop members, The biopsy marker of the push rod
. 15. The method of claim 14,
And a tip inserted into the first end of the tube. 16. The method of claim 15,
Wherein the tip comprises a ramp portion. 15. The method of claim 14,
Wherein the opening comprises a side opening. 15. The method of claim 14,
And an elastic member extending from a distal end of the push rod. A cannula having a first end and a first opening, the cannula comprising a first material;
At least one biopsy marker positioned proximal to the first opening;
A sleeve disposed on at least a portion of the first end of the cannula, the sleeve including a second opening, the second opening of the sleeve being aligned with the first opening of the cannula, Wherein the sleeve further comprises a second material and wherein the second material of the sleeve has a flexibility or resiliency less than the flexibility or resiliency of the first material of the cannula;
A member having a first end disposed at least partially within the cannula, the member having a first opening and a second opening, the member having a first opening and a second opening, And is movable in a direction toward one end,
. A tube having a first end and a side opening;
At least one biopsy marker positioned proximal to the side opening;
A push rod having a first end at least partially disposed within the tube, the push rod being movable in a direction toward the first end thereof to deploy the at least one biopsy marker;
An actuator having a plunger, the actuator communicating with the tube and the push rod, the plunger of the actuator being movable through a first position and a second position, the actuator being configured to move the plunger to the first position Wherein the actuator is configured to rotate the tube when the plunger is moved to the second position, wherein the actuator is configured to move the pushrod in a direction toward the first end of the actuator,
.

Images