阅读说明：本技术 活检部位标记物释放器 (Biopsy site marker releaser ) 是由 迈克尔·E·约翰森 蒂莫西·齐默 阿尔贝托·卡博罗·兰格尔 于 2014-03-12 设计创作，主要内容包括：本申请涉及活检部位标记物释放器。标记物递送装置包括：标记物放置器套管、推杆、活检部位标记物以及倾斜尖端。标记物放置器套管可具有与套管的内部管腔连通的标记物出口。所述标记物出口可包括具有倾斜表面的远端。所述活检部位标记物可配置有多条边。所述多条边可被配置为与所述套管的内部管腔的至少一部分相接合。所述倾斜尖端可包括第一倾斜表面和第二倾斜表面,所述第二倾斜表面可与所述标记物出口的远端的倾斜表面对齐。所述推杆可用于将所述活检部位标记物推至倾斜末端并且使其通过标记物出口。(The present application relates to biopsy site marker releasers. The marker delivery device includes: a marker placer cannula, a push rod, a biopsy site marker, and a beveled tip. The marker placer cannula may have a marker outlet in communication with the interior lumen of the cannula. The marker exit port may include a distal end having a beveled surface. The biopsy site marker may be configured with a plurality of edges. The plurality of edges may be configured to engage at least a portion of the inner lumen of the cannula. The beveled tip may include a first beveled surface and a second beveled surface, and the second beveled surface may be aligned with the beveled surface of the distal end of the marker exit. The push rod may be used to push the biopsy site marker to an angled end and through a marker exit.)

1. A marker delivery device comprising:

(a) a marker deployer cannula, comprising:

(i) at the far-end of the device,

(ii) at the proximal end thereof,

(iii) an inner lumen, and

(iv) a marker exit comprising a marker exit distal end, wherein the marker exit distal end comprises a first marker exit ramped surface;

wherein the marker exit port is proximally spaced from the distal end of the marker deployer cannula; and wherein the marker outlet is in communication with the internal lumen;

(b) a push rod having a distal end, wherein the push rod is slidably disposed within the marker placer sleeve;

(c) a biopsy site marker; and

(d) a beveled tip, the beveled tip comprising:

(i) a distal tip, and

(ii) a beveled portion having a first beveled surface and a second beveled surface, wherein the beveled portion extends proximally from the distal tip; wherein the first inclined surface is positioned proximally from and directly adjacent to the second inclined surface; wherein the first inclined surface has a first included angle; wherein the second inclined surface has a second included angle, the first included angle being different from the second included angle; wherein the second angled surface is configured to align with an angled surface distal to the marker exit;

wherein the beveled tip is insertable into the distal end of the marker placer cannula;

wherein the marker delivery device is operable to place the biopsy site marker at a biopsy site; and is

Wherein the first angled surface has a first included angle that is greater than a second included angle of the second angled surface, the first marker exit angled surface comprises an included angle, and the included angle of the first marker exit angled surface is substantially the same as the second included angle of the second angled surface of the angled tip.

2. The marker delivery device of claim 1, wherein the beveled tip further comprises a marker engagement step.

3. The marker delivery device of claim 1, wherein the marker engagement step extends proximally from the ramp.

4. The marker delivery device of claim 2, wherein the marker engagement step comprises a tapered proximal end.

5. The marker delivery device of claim 1, wherein the marker outlet further comprises a proximal marker outlet end, wherein the proximal marker outlet end has a second marker outlet inclined surface with an included angle, wherein the included angle of the second marker outlet inclined surface is substantially the same as the included angle of the first marker outlet inclined surface.

6. The marker delivery device of claim 1, wherein the biopsy site marker includes an outwardly extending rim, wherein the outwardly extending rim includes a plurality of ribs extending from a substantially cylindrical surface of the biopsy site marker.

7. The marker delivery device of claim 6, wherein each of the plurality of ribs comprises a protrusion, wherein each protrusion is configured to engage at least a portion of the inner lumen of the marker deployer cannula.

8. The marker delivery device of claim 1, wherein the biopsy site marker includes an outwardly extending edge, wherein the outwardly extending edge is defined by four sides of the biopsy site marker.

9. The marker delivery device of claim 8, wherein each of the four sides is connected to another side to form each outwardly extending edge of the plurality of edges of the biopsy site marker.

10. The marker delivery device of claim 1, wherein the biopsy site marker further comprises a rounded bottom surface, wherein the bottom surface is configured to engage at least a portion of an internal lumen of the marker deployer cannula.

11. The marker delivery device of claim 10, wherein the biopsy site marker comprises a plurality of outwardly extending sides, wherein the plurality of outwardly extending sides comprises two corners, wherein the two corners are defined by two side surfaces extending from the rounded bottom surface and a rounded top surface.

12. A system, comprising:

(a) a biopsy device comprising a biopsy needle, wherein the biopsy needle has a distal end comprising a tissue piercing tip and a tissue receiving aperture disposed proximate the distal end;

(b) the marker delivery device includes:

(i) a marker deployer cannula having an inner surface and including a distal end, an inner lumen, and a marker exit port; wherein the marker exit port is proximally spaced from the distal end of the marker deployer cannula; wherein the marker outlet is in communication with the internal lumen; wherein the marker outlet comprises a marker outlet distal end having a sloped surface;

(ii) a push rod having a distal end, wherein the push rod is slidably disposed within the marker placer sleeve; and

(iii) a beveled tip, the beveled tip comprising:

(1) a distal tip, and

(2) a beveled portion having a first beveled surface and a second beveled surface, the first beveled surface having a first included angle and the second beveled surface having a second included angle, wherein the first beveled surface is positioned proximally from and directly adjacent to the second beveled surface, the first included angle being greater than the second included angle, the first marker outlet beveled surface comprising an included angle, the first marker outlet beveled surface included angle being substantially the same as the second included angle of the second beveled surface of the beveled tip;

(c) a biopsy site marker, wherein the biopsy site marker has a plurality of edges and a plurality of surfaces; wherein each of the plurality of edges is configured to engage at least a portion of an inner diameter of the marker deployer cannula and each of the plurality of surfaces is configured to turn outward toward an inner surface of the cannula;

wherein the marker delivery device is configured to be insertable into the biopsy device such that the marker outlet of the marker delivery device is aligned with the tissue receiving aperture of the biopsy device; wherein the pusher is configured to push the biopsy site marker up the sloped portion of the sloped tip and pass the biopsy site marker through a tissue receiving aperture of the biopsy device.

13. The system of claim 12, wherein each of the plurality of edges of the biopsy site marker comprises a rib; wherein the rib comprises at least one protrusion; wherein the rib and each protrusion of each of the plurality of edges are configured to engage at least a portion of the inner diameter of the marker placer sleeve.

14. The system of claim 12, wherein the biopsy site marker includes a rounded top surface and a rounded bottom surface; wherein the circular bottom surface defines two side surfaces; wherein the side surface and the rounded top surface together define a first edge and a second edge of the plurality of edges.

15. The system of claim 12, wherein the biopsy site marker comprises compressed collagen.

16. A marker delivery device comprising:

(a) a cannula including a proximal end, a distal tip, a side opening, and a gripping portion coupled to the cannula; wherein the side opening is positioned proximally of the cannula relative to the distal tip; wherein the side opening includes a distal end having a beveled portion;

(b) at least one biopsy marker disposed proximally relative to the side opening of the cannula;

(c) a push rod having a distal end and a plunger connected to the push rod; wherein the push rod is slidably disposed within the cannula to extend proximate to the at least one biopsy marker; and

(d) a beveled end piece disposed within the distal end of the cannula; wherein the angled end piece comprises a distal tip and a compound angled portion; wherein at least a portion of the distal tip extends distally from the distal end of the cannula; wherein the compound angled portion extends proximally from a distal end of the angled end piece; wherein the compound angled portion includes a first angled surface having a first included angle and a second angled surface having a second included angle, the first angled surface being adjacent to the second angled surface, the first included angle being different from the second included angle in that the first included angle is greater than the second included angle; wherein the second inclined surface is configured to align with an inclined portion of a distal end of the side opening; wherein the first marker exit sloping surface comprises an included angle that is substantially the same as a second included angle of the second sloping surface of the sloping tip;

wherein the grip and the plunger are configured to be manipulated by a single hand; wherein the pusher bar is movable in a distal direction to deploy the at least one biopsy marker from the cannula through the side opening.

Background

Biopsy samples have been obtained in a variety of ways in various medical procedures using a variety of devices. These biopsy devices may be used under the guidance of stereotactic guides, ultrasound guides, MRI guides, PEM guides, BSGI guides, or other guides.

Other exemplary biopsy devices are disclosed in the following documents: U.S. Pat. No.5,526,822 entitled "Method and apparatus for Automated Biopsy and Collection of Soft Tissue" published at 18.6.1996; U.S. patent No.6,086,544 entitled "Control Apparatus for an Automated surgery biopsy Device" issued at 11.7.2000; U.S. patent application publication No.2003/0109803 entitled "MRI compatible biological Device" published on 12/6/2003, U.S. Pat. No.6,626,849; U.S. patent application publication No.2007/0118048 entitled "Remote thumb for a scientific Biopsydevice" published 24.5.2007, U.S. patent No.7,442,171; U.S. patent No.7,938,786 entitled "Vacuum Timing Algorithm for Biopsy Device" issued 5/10/2011; U.S. patent No.8,118,755 entitled "Biopsy Sample Storage" published on day 2/21 of 2012; U.S. patent application publication No.2008/0146962 entitled "Biopsy System with Vacuum Control Module" published on 19.6.2008; U.S. patent No.8,251,916 entitled "revolling Tissue Sample Holder for biopsy Device" published on 28/8/2012; and U.S. patent No.8,532,747 entitled "BiopsyMarker Delivery Device" issued on 9, 10, 2013. The disclosure of each of the above-referenced U.S. patents, U.S. patent application publications, is incorporated herein by reference.

In some setup procedures, it may be desirable to mark the location of the biopsy site for subsequent reference. For example, one or more markers may be placed at a biopsy site before, during, or after a tissue sample is collected from the biopsy site. An exemplary marker placement tool includes a Devicor Medical Product, Inc. under the trademark MAMMOMARK, Cincinnati, Ohio^TM、And CORMARK^TMThe apparatus of (1). Other exemplary devices and methods for marking a biopsy site are disclosed in the following documents: U.S. patent application publication No.2005/0228311 entitled "Marker Device and method of exploiting a capacitive Marker Using a scientific Biopsy Device" published at 13.10.2005, U.S. Pat. No.7,465,279; U.S. Pat. No.6,996,433 entitled "Imageable Biopsy Site Marker" published on 7.2.2006; U.S. Pat. No.6,993,375 entitled "Tissue Site Markers for In Vivo Imaging" published on 31.1.2006; U.S. patent No.7,047,063 entitled "Tissue Site Markers for In Vivo Imaging" published on 16.5.2006; U.S. patent No.7,229,417 entitled "Methods for Marking a Biopsy Site" published on 12.6.2007; U.S. Pat. No.7,044,957 entitled Devices for Defining and Marking Tissue, published on 16.5.2006; U.S. Pat. No.6,228,055 entitled "Devices for Marking and defining particulate Locations in Body Tissue" published on 8.5.2001; and U.S. patent No.6,371,904 entitled "a sports Marking Device and Method" published on 16.4.2002. The disclosure of each of the above-mentioned U.S. patents and U.S. patent application publications is incorporated herein by reference.

While systems and methods for obtaining biopsy samples have been obtained and used, it is believed that the present invention as defined in the following claims has not been obtained or used in the prior art.

Drawings

While the technology has been particularly pointed out and distinctly claimed in the concluding portion of the specification, it is believed that the invention will be better understood from the following description of certain embodiments taken in conjunction with the accompanying drawings, in which like reference numerals identify similar elements, and in which:

FIG. 1 is a perspective view of a marker delivery device;

FIG. 2 is a cross-sectional view of a distal portion of the marker delivery device of FIG. 1;

FIG. 3 is a cross-sectional view of a biopsy site marked by placing a marker from a distal portion of the marker delivery device of FIG. 1 and through a lateral tissue receiving aperture of a biopsy needle;

FIG. 4 is a perspective view of another exemplary marker delivery device;

FIG. 5 is a perspective view of an end piece of the marker delivery device of FIG. 4;

FIG. 6 is a cross-sectional view of a distal portion of the marker delivery device of FIG. 4;

FIG. 7 is a perspective view of a marker for use with the marker delivery device of FIG. 4;

FIG. 8 is a front view of the tag of FIG. 7;

FIG. 9 is a cross-sectional view of the marker of FIG. 7 within the shaft of the marker delivery device of FIG. 4;

FIG. 10 is a perspective view of another exemplary marker for use with the marker delivery device of FIG. 4;

FIG. 11 is a front view of the tag of FIG. 10;

FIG. 12 is a cross-sectional view of the marker of FIG. 10 within the shaft of the marker delivery device of FIG. 4;

FIG. 13 is a perspective view of another exemplary marker for use with the marker delivery device of FIG. 4;

FIG. 14 is a front view of the tag of FIG. 13; and

fig. 15 is a cross-sectional view of the marker of fig. 13 within the shaft of the marker delivery device of fig. 4.

The figures are not intended to be limiting in any way, and it is contemplated that the techniques in other embodiments may be performed in other ways, including those not specifically described in the figures. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present technology and, together with the description, serve to explain the principles of the technology. It should be understood, however, that the present technology is not limited to the particular arrangements shown.

Detailed Description

The following description of some embodiments of the invention is not intended to limit the scope of the invention. Other embodiments, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the present invention. It will be appreciated that the technology described herein is also capable of achieving other different and obvious aspects, all without departing from the technology. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

I. Exemplary marker delivery device

Fig. 1 shows a marker delivery device 10, the marker delivery device 10 including an elongate outer cannula 12 having a marker outlet, such as a side opening 14 formed adjacent a distal end of the cannula 12 but spaced proximally from the distal end of the cannula 12.

A grip 16 may be provided at the proximal end of the cannula 12. The pushrod 18 may be configured to extend coaxially within the cannula 12 such that the pushrod 18 is configured to translate within the cannula 12 to facilitate placement of one or more markers through the side opening 14 (see fig. 2). The rod 18 may have sufficient rigidity when compressed to push the marker out of the inner lumen 15 of the cannula 12 through the opening 14, while at the same time being relatively flexible when bent. A plunger 20 may be connected at the proximal end of the rod 18 for forcing the rod 18 to move distally within the cannula 12 for placement of the marker out of the cannula 12.

The user may grasp the grip portion 16 with two fingers and may push the plunger 20 with the thumb of the same hand so that the user can operate the marker delivery device 10 with a single hand. A spring (not shown) or other member may also be disposed about the stem 18 to bias the stem 18 proximally relative to the grip 16 and the sleeve 12.

Fig. 2 shows a cross-sectional view of the distal portion of the marker delivery device 10. Fig. 2 shows a biopsy marker 300 disposed in the inner lumen 15 of the cannula 12. In this embodiment, the marker 300 includes a biodegradable or absorbable body 306, such as a generally cylindrical collagen body; and a metallic substantially radiopaque marker element 310 (shown in phantom) disposed within or carried by the body 306.

The sleeve 12 may be formed from any suitable metallic or non-metallic material. In some variations, the sleeve 12 is formed from a thin-walled hollow tube formed from any suitable medical grade plastic or polymer. One suitable material is a thermoplastic elastomer such as polyether block amide (PEBA) known under the trade name PEBAX. The cannula 12 may be formed of PEBAX and may be substantially transparent to visible light and X-rays.

The side opening 14 may be formed by cutting away a portion of the wall of the cannula 12. The side opening 14 communicates with the inner lumen 15 of the cannula 12. As shown in fig. 2, the side opening 14 may extend axially (in a direction parallel to the axis of the lumen 15) from a proximal open end 14A to a distal open end 14B.

In this embodiment, as shown in FIG. 2, the distal tip 22 extends from the distal end of the cannula 12 and is rounded. Referring to fig. 2, the distal end of the cannula 12 is closed by an integral end piece 21, wherein a portion of the end piece 21 extends into the inner lumen 15 of the cannula 12. The end piece 21 may be a molded or cast part. The end piece 21 includes a tip 22, an inclined portion 210 having an inclined surface 212, and a marker engagement element 240. The sloped surface 212 assists in guiding the marker 300 from the interior lumen 15 through the side opening 14. The marker engagement element 240 helps to retain the marker 300 within the inner lumen 15 until the user intends to place the marker 300.

The marker engaging element 240 is disposed within the inner lumen 15, and at least a portion of the marker engaging element 240 is disposed distal to the proximal end 14A of the side opening 14. The marker engagement element 240 extends along a portion of the bottom wall of the sleeve 12 below the opening 14 such that the marker engagement element 240 is positioned to reinforce the portion of the sleeve 12 having the opening 14 formed therein. For example, by positioning the marker engagement element 240 below the opening 14, as shown in FIG. 2, the element 240 helps to strengthen the sleeve 12 in the area of the wall of the sleeve 12 that is cut to form the opening 14. As shown in fig. 2, the marker engaging element 240 extends from the proximal-most end of the inclined surface 212 and does not extend proximally of the side opening 14, although in other embodiments a portion of the element 240 may extend proximally of the opening 14.

As shown in FIG. 2, the marker engaging element 240 is stepped in form having a generally uniform thickness T along the axial length of the element 240, except that the element 240 has a tapered proximal end 242. Tapered proximal end 242 forms an angle of about 45 degrees with the longitudinal axis of lumen 15 (from horizontal in fig. 2), while inclined surface 212 forms an angle of about 30 degrees with the longitudinal axis. Of course, any other suitable angle of any value may be used. The thickness T may be greater than the wall thickness T of the casing 12. In some variations, the thickness T is at least about 2 times the thickness T. For example, the thickness T can be between about 0.018 inches to about 0.040 inches, and the wall thickness T can be between about 0.005 inches to about 0.008 inches. The inner diameter of lumen 15 may be about 0.120 inches. Of course, any other suitable thickness and diameter may be used.

As shown in fig. 2, the upward facing surface 244 (the surface facing the opening 14) of the marker engagement element 240 extends distally to contact the inclined surface 212 such that there is no space or gap between the surface 244 and the inclined surface 212. This arrangement is beneficial in reducing the likelihood that the marker 300 will become caught between the marker-engaging element 240 and the angled portion 212 during movement past the marker-engaging element 240. In some variations, marker-engaging element 240, ramp 210, and/or tip 22 are formed from or include a material that is relatively more radiopaque than the wall of cannula 12. For example, where the element 240, the angled portion 210, and the tip 22 are formed as a unitary end piece 21, the end piece 21 may include a radiopaque additive, such as barium sulfate. For example, the end piece 21 may be a PEBAX molded part, wherein about 20 wt% barium sulfate is added to the molten PEBAX molding composition. The relatively more radiopaque marker-engaging element 240, the ramp 210, and the tip 22 are useful in radiographic imaging techniques to identify the location of these components. Also, the location where the ramp 210 and/or stepped engagement element 240 are positioned is related to the opening 14, so the addition of radiopaque material can help determine the location of the opening 14, as well as the position of the marker 300 relative to the opening 14, before, during, or after placement of the marker 300.

In the figures, only one marker 300 is shown disposed within the lumen 15. However, it should be understood that a plurality of markers 300 may be provided in the marker delivery device 10, such as in an end-to-end configuration. The markers 300 may be the same size and shape, or alternatively, different sizes and/or shapes.

The sleeve 12 is substantially transparent to visible light and X-rays and the end piece 21 is substantially opaque to visible light and X-rays. This may entail coloring the end member 21 by adding a dye or other suitable colorant to the liquid molding composition. For example, different sizes of markers 300 (e.g., length and/or diameter) may be required for different biopsy procedures. For example, when taking a relatively large biopsy sample, it may be desirable to provide a larger marker 300; whereas when taking a relatively small biopsy sample, it may be desirable to provide a smaller marker 300. The end member 21 may be colored with one of a plurality of colors to indicate the size of the marker 300 disposed in the sleeve 12. For example, if 3 marker 300 sizes are provided, the end piece 21 may be colored one of 3 colors to determine the size of the marker 300 disposed in the sleeve 12 of the marker device 10. End member 21 may also be colored to indicate the particular size (diameter or length) of the biopsy needle that will be used with marker delivery device 10. Further, a plurality of marker delivery devices 10 may be packaged in a kit including marker delivery devices 10 having different sized markers 300 and correspondingly colored end pieces 21.

Referring to fig. 3, the marker delivery device 10 is used to place a marker 300 to mark a biopsy location within a patient. In fig. 3, a tubular biopsy needle 1000 is shown, the tubular biopsy needle 1000 having a closed distal end with a piercing tip 1002 and a lateral tissue receiving aperture 1014. The marker placer 10 is introduced to the biopsy site by means of a biopsy needle 1000, wherein the biopsy needle 1000 may be the same needle used for collecting a tissue sample from the biopsy site. Biopsy needle 1000 may be of the type used with single insertion, multiple sample vacuum assisted biopsy devices. Several such biopsy needles are disclosed in the various patents and patent applications incorporated herein by reference, although other biopsy devices may also be used.

FIG. 3 shows the distal end of the marker placer 10 disposed within the needle 1000. The needle 1000 may be positioned within tissue and a biopsy sample may be obtained through the opening 1014, thus providing a biopsy cavity near the opening 1014. Subsequently, after a tissue sample has been obtained and transferred proximally through the needle 1000, the placer 10 is inserted into the proximal opening in the needle 1000 without removing the needle 1000 from the patient tissue. In FIG. 3, the needle 1000 and the placer 10 are positioned with the opening 14 of the cannula 12 substantially aligned with the opening 1014 of the needle 1000 both axially and circumferentially. Subsequently, with the applier 10 and needle 1000 so positioned at the biopsy site, the pusher bar 18 is pushed to push the marker 300 up the ramped surface 212, through the opening 14, and then through the opening 1014 into the biopsy cavity.

In some instances, the distal open end 14B may not be aligned with the ramped surface 212 due to accidental error during manufacture and/or assembly of the marker delivery device 10. Thus, when the marker 300 is placed from the device 10, the marker 300 may become stuck at the distal open end 14B. Thus, it may be desirable to incorporate a second angled feature in the end piece 21 to enable smooth placement of the marker 300 from the device 10 even if the angled surface 212 is not aligned with the distal open end 14, as described below.

Another exemplary marker delivery device 110 similar to marker delivery device 10 is shown in fig. 4, except that marker delivery device 110 includes a composite angled end member 121. Similar to marker delivery device 10, marker delivery device 110 includes a sleeve 112, a side opening 114, a grip 116, a plunger 120, and an end piece 121. As shown in fig. 5, end piece 121 is similar to end piece 21, wherein end piece 121 includes an angled portion 311 and a rounded distal tip 122. Marker engaging element 340 and tip 122 are similar to marker engaging element 240 and tip 22. Angled portion 311 is similar to angled portion 210, except that angled portion 311 includes a first angled surface 312 and a second angled surface 314 distal to first angled surface 312. The second inclined surface 314 is inclined at an angle relative to the longitudinal axis of the end piece 121 that is less than the inclined surface 312.

Fig. 6 shows the end piece 121 coupled to the sleeve 112 such that a portion of the end piece 121 is inserted into the distal portion of the sleeve 112. The marker engagement element 340 is adjacent the side opening 114 of the cannula 112. The tapered proximal end 342 of the marker engagement element 340 forms an angle of about 45 degrees with the longitudinal axis of the lumen 115. First angled surface 312 forms an angle of about 30 degrees with the longitudinal axis of lumen 115. Second angled surface 314 forms an angle of about 21 degrees with the longitudinal axis of lumen 115. Of course, other suitable angles of any value may be used. The distal open end 114B of the opening 114 is formed at substantially the same angle as the second inclined surface 314 such that the second inclined surface 314 and the distal open end 114B of the sleeve 112 form a substantially flush surface when the end piece 121 is inserted within the sleeve 112. For example, the end piece 121 may be insert molded in the sleeve 112 and constructed with a tapered distal end 342, a marker engagement element 340, and a first angled surface 312. The side opening 114 can then be cut to form the proximal open end 114A, the distal open end 114B, and the second angled surface 314 of the end piece 121. This creates a substantially flush surface between the sleeve 112 and the end piece 121. In some other variations, the end piece 121 may be manufactured first and then assembled with the sleeve 112. After assembly of the end piece 121 and the sleeve 112, the second inclined surface 314 and the distal open end 114B may be cut together. In some other variations, the second inclined surface 314 and the distal open end 114B may also be cut out first and then assembled together. Even if the second angled surface 314 and the distal open end 114B are inadvertently misaligned during assembly, the marker 300 may still be successfully placed from the device 110 because the second angled surface 314 and the distal open end 114B have a shallower angle than the first angled surface 312.

Marker delivery device 110 may be used to place marker 300 to mark a biopsy location within a patient. For example, the marker delivery device 110 can be introduced to the biopsy site through a biopsy needle 1000, which biopsy needle 1000 may be the same needle used to collect a tissue sample from the biopsy site. The needle 1000 may be positioned within tissue and a biopsy sample may be obtained through the opening 1014, thus providing a biopsy cavity near the opening 1014. Subsequently, after a tissue sample has been obtained and transferred proximally through the needle 1000, the marker delivery device 110 is inserted into the proximal opening in the needle 1000 without removing the needle 1000 from the patient tissue. The needle 1000 and marker delivery device 110 are positioned such that the opening 114 of the cannula 112 is substantially aligned with the opening 1014 of the needle 1000 both axially and circumferentially. The marker 300 is positioned within the lumen 115 of the cannula 112 proximate to the marker-engaging element 340 such that the marker-engaging element 340 retains the marker 300 within the cannula 112. Subsequently, with the placer 110 and needle 1000 so positioned at the biopsy site, the push rod 118 is pushed to place the marker 300. As the push rod 118 advances the marker 300, the marker 300 continually slides along the ramped proximal end 342 of the marker engagement element 340, up the upward facing surface 344, and to the first and second ramped surfaces 312, 314. The marker 300 is then placed through the opening 114 and then through the opening 1014 of the needle 1000 into the biopsy cavity.

Exemplary markers

Fig. 7-8 illustrate an exemplary marker 400 that may be placed by the marker delivery device 10, 110 to mark a biopsy site. The marker 400 is similar to the marker 300 described above, except that the marker 400 has a modified shape compared to the cylindrical marker 300. As shown in fig. 8, the marker 400 includes a rounded top surface 402 positioned between corners 410, 412 extending outwardly from the marker 400. Side surface 408 extends downward from corner 410 and opposing side surface 404 extends downward from corner 412. A rounded bottom surface 406 connects the side surfaces 404, 408. The marker 400 is biodegradable or bioabsorbable. Thus, the marker 400 may be made of collagen, or of any suitable material, including but not limited to the various marker body materials taught in the references cited herein. The marker 400 includes a substantially radiopaque (e.g., metallic) marker element (not shown) disposed within the marker 400 or carried by the marker 400.

The marker 400 may be inserted within the cannula 12, 112 of the marker delivery device 10, 110 for placement at a biopsy site, as shown in fig. 9. When the marker 400 is inserted within the sleeve 12, 112, the corners 410, 412 and the bottom surface 406 engage the inner diameter of the sleeve 12, 112. Thus, when the corners 410, 412 are engaged with the sleeves 12, 112, the corners 410, 412 may bend or deform inwardly. This may cause the side surfaces 404, 408 to bow outward. In some variations, the side surfaces 404, 408 are curved outward to contact the inner diameter of the sleeve 12, 112, while in other variations, the side surfaces are not in contact with the inner diameter of the sleeve 12, 112. The contact of the corners 410, 412 and bottom surface 406 of the marker 400 with the sleeves 12, 112 provides sufficient frictional resistance between the marker 400 and the sleeves 12, 112 to prevent the marker from inadvertently falling out of the side openings 14, 114 before the push rods 18, 118 are actuated to place the marker 400, while still allowing the marker 400 to be placed from the sleeves 12, 112 without excessive force. Because the marker 400 is engaged with the sleeve 12, 112 through the corners 410, 412, the force required to push the marker 400 out of the sleeve 12, 112 may be less than the force required to push the marker 300 out of the sleeve 12, 112.

Fig. 10-11 illustrate an exemplary marker 500, which exemplary marker 500 may be placed by the marker delivery device 10, 110 to mark a biopsy site. The marker 500 is similar to the marker 300 described above, except that the marker 400 has a modified shape compared to the cylindrical marker 300. As shown in fig. 11, the marker 500 includes a rectangular shape having a top surface 502, a bottom surface 506, and side surfaces 504, 508. Thus, surfaces 502, 504, 506, 508 form corners 501, 503, 505, 507 between surfaces 502, 504, 506, 508. Although the marker 500 has a rectangular shape in this embodiment, the marker 500 may have other suitable shapes such as a square, triangle, pentagon, or other polygon. The marker 500 is biodegradable or bioabsorbable. Thus, the marker 500 may be made of collagen, or of any suitable material, including but not limited to the various marker body materials taught in the references cited herein. The marker 500 includes a substantially radiopaque (e.g., metallic) marker element (not shown) disposed within the marker 500 or carried by the marker 500.

The marker 500 may be inserted within the cannula 12, 112 of the marker delivery device 10, 110 for placement at the biopsy site, as shown in fig. 12. When the marker 500 is inserted within the cannula 12, 112, the corners 501, 503, 505, 507 engage the inner diameter of the cannula 12, 112. Thus, when the corners 501, 503, 505, 507 are engaged with the sleeves 12, 112, the corners 501, 503, 505, 507 may bend or deform inwardly. This may cause the side surfaces 502, 504, 506, 508 to bow outward. In some variations, the side surfaces 502, 504, 506, 508 are curved outward to contact the inner diameter of the sleeve 12, 112, while in other variations, the side surfaces 502, 504, 506, 508 are not in contact with the inner diameter of the sleeve 12, 112. The contact of the corners 501, 503, 505, 507 of the marker 500 with the sleeves 12, 112 provides sufficient frictional resistance between the marker 500 and the sleeves 12, 112 to prevent the marker 500 from inadvertently falling out of the side openings 14, 114 before the push rods 18, 118 are actuated to place the marker 500, while still allowing the marker 500 to be placed from the sleeves 12, 112 without excessive force. Since the marker 500 is engaged with the sleeve 12, 112 through the corners 501, 503, 505, 507, the force required to push the marker 500 out of the sleeve 12, 112 may be less than the force required to push the marker 300 out of the sleeve 12, 112.

Fig. 13-14 illustrate an exemplary marker 600 that may be placed by the marker delivery device 10, 110 to mark a biopsy site. The marker 600 is similar to the marker 300 described above, except that the marker 600 includes a plurality of ribs 601, 603, 605 extending outwardly from the marker 600. The ribs 601, 603, 605 extend longitudinally along the outer surface 602 of the tag 600 and equally spaced around the outer surface 602 of the tag 600. Although three ribs 601, 603, 605 are shown, other suitable numbers of ribs 601, 603, 605 may be used. The ribs 601, 603, 605 can also be non-uniformly positioned around the outer surface 602 of the tag 600. As best shown in fig. 14, each rib 601, 603, 605 includes a protrusion 604, 606, 608 extending outwardly from each rib 601, 603, 605. The diameter of the marker 600 may be about 0.066 inches. The ribs 601, 603, 605 may extend about 0.0025 inches beyond the diameter of the marker 600. Of course, any other suitable diameter and length may be used. It should be noted that the protrusions 604, 606, 608 are merely optional. The marker 600 is biodegradable or absorbable. Thus, the marker 600 may be made of collagen, or of any suitable material, including but not limited to the various marker body materials taught in the references cited herein. The marker 600 includes a substantially radiopaque (e.g., metallic) marker element (not shown) disposed within the marker 600 or carried by the marker 600.

The marker 600 may be inserted within the cannula 12, 112 of the marker delivery device 10, 110 for placement at a biopsy site, as shown in fig. 15. The ribs 601, 603, 605 engage the inner diameter of the sleeve 12, 112 when the marker 600 is inserted within the sleeve 12, 112. The ribs 601, 603, 605 may flex or deform inwardly when the ribs 601, 603, 605 engage the sleeve 12, 112. The ribs 601, 603, 605 may be bent such that the protrusions 604, 606, 608 engage the inner diameter of the sleeve 12, 112. Thus, the protrusions 604, 606, 608 help to retain the marker 600 within the sleeve 12, 112. The outer surface 602 of the marker 600 may also flex outwardly as the marker 600 is inserted into the cannula 12, 112. In some variations, the surface 602 curves outward to contact the inner diameter of the sleeve 12, 112, while in other variations, the surface 602 does not contact the inner diameter of the sleeve 12, 112. The contact of the ribs 601, 603, 605 and/or the protrusions 604, 606, 608 of the marker 600 with the sleeves 12, 112 provides sufficient frictional resistance between the marker 600 and the sleeves 12, 112 to prevent the marker 600 from inadvertently falling out of the side openings 14, 114 prior to driving the push rods 18, 118 to place the marker 600, while still allowing the marker 600 to be placed from the sleeves 12, 112 without excessive force. Because the marker 600 is engaged with the sleeve 12, 112 via the ribs 601, 603, 605, the force required to push the marker 600 out of the sleeve 12, 112 can be less than the force required to push the marker 300 out of the sleeve 12, 112.

Summary of the invention

It should be understood that patents, publications, or other disclosure materials, in whole or in part, that are incorporated by reference herein are incorporated herein only to the extent that such incorporated materials do not conflict with existing definitions, statements, or other disclosure materials set forth in this disclosure. Accordingly, and where necessary, the disclosure explicitly shown herein supersedes any conflicting material incorporated herein by reference. That is, any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

Embodiments of the present invention find application in conventional endoscopic and open surgical instruments as well as in robotic-assisted surgery.

By way of example only, embodiments described herein may be processed prior to surgery. First, a new or used instrument is obtained and cleaned as needed. The instrument may then be sterilized. In one sterilization technique, the instrument is placed in a closed, sealed container (e.g., a plastic or TYVEK bag). The container and instrument may then be placed in a region of radiation that is transparent to the container, such as gamma radiation, x-rays, or high energy electrons. The radiation may kill bacteria on the instrument and in the container. The sterilized instrument may then be stored in the sterile container. The sealed container may keep the instrument sterile until the container is opened in a medical facility. The device may also be sterilized using other techniques known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

Embodiments of the devices disclosed herein may be reconditioned for reuse after at least one use. The repair may include a combination of the following steps: disassembly of the device, subsequent cleaning or replacement of particular pieces, and subsequent reassembly. In particular, embodiments of the devices disclosed herein may be disassembled, and any number of the particular pieces or parts of the device may be selectively replaced or removed in any combination. With cleaning and/or replacement of particular components, embodiments of the device may be assembled for subsequent use at a repair facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that the device may be reconditioned using a variety of techniques for disassembly, cleaning/replacement, and assembly. The use of these techniques and the resulting reconditioned device are all within the scope of the present invention.

While various embodiments of the present invention have been shown and described, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of these possible modifications have been mentioned, while others will occur to those skilled in the art. For example, the above examples, embodiments, geometries, materials, dimensions, ratios, steps, and the like are illustrative and not required. The scope of the present invention should, therefore, be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.