HK1191207B - Biopsy marker delivery device - Google Patents

Description

Biopsy marker delivery device

The present application is a divisional application of the invention patent application having an application date of 2009, 21/8, application No. 200910167431.6, entitled "biopsy marker delivery device".

Technical Field

The invention relates to a biopsy marker delivery device.

Background

Biopsy samples may be obtained by various methods in various medical procedures using various devices. Of Ethicon Endo-Surgery, Inc. of Cincinnati, OhioThe placard device is one exemplary biopsy device. The use of the biopsy device may be guided by a stereotactic guide, an ultrasound guide, a magnetic resonance guide, or the like.

Further exemplary biopsy devices are disclosed in the following documents, including: U.S. Pat. No.5,526,822, issued at 18.6.1996 and entitled "Method and Apparatus for Automated Biopsy and selection of Soft Tissue"; U.S. patent No.6,086,544, issued on 11/7/2000 and entitled "Control Apparatus for an Automated scientific BiopsyDevice"; U.S. patent publication No.2003/0109803 entitled "MRICompatible scientific Biopsy Device" published at 12.6.2003; U.S. patent publication No.2007/0118048 entitled "Remote thumb for a scientific Biopsy Device," published 24.5.2007; U.S. provisional patent application No.60/869,736, entitled Biopsy System, filed on 13.12.2006; U.S. provisional patent application No.60/874,792, entitled "Biopsy SampleStorage", filed on 13.2006; and U.S. non-provisional patent application serial No.11/942,785, entitled "Revolving Tissue Sample Holder for Biopsydevice", filed on 21.11.2007. The disclosures of each of the above-mentioned U.S. patents, U.S. patent application publications, U.S. provisional patent applications, and U.S. non-provisional patent applications are hereby incorporated by reference.

In some cases, 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 the biopsy site before, during, or after the tissue sample is removed from the biopsy site. Exemplary marker placement tools include Ethicon Endo-Surgery, Inc. of Cincinnati, OhioAnda card device. Further exemplary devices and methods for marking a biopsy site are disclosed in the following documents, including: U.S. patent publication No.2005/0228311 entitled "Marker Device and Method of exploiting a category Marker Using a scientific Biopsy Device" published at 13.10.2005; U.S. Pat. No.6,996,433, issued on 7.2.2006, entitled "Imageable Biopsy SiteMarker"; U.S. patent No.6,993,375 entitled "Tissue Site Markers for In Vivo Imaging" published 31.2006; U.S. patent No.7,047,063 entitled "Tissue Site Markers for In Vivo Imaging" issued on day 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, issued on day 16, 5/2006, entitled "Devices for Defining and Marking Tissue"; U.S. Pat. No.6,228,055, issued on 8.5.2001 and entitled "Devices for Marking and defining particulate Locations in Body Tissue"; and U.S. patent No.6,371,904, entitled "nobutaneous catalyst marking Device and Method", published on 16.4.2002. The disclosures of each of the above-mentioned U.S. patents and U.S. patent application publications are hereby incorporated by reference.

It may be desirable to place a marker into the biopsy site from a cannula-type placer. The marker cannot inadvertently fall out of the applicator and the force required to place the marker cannot be excessive.

Disclosure of Invention

(1) A biopsy marker delivery device, comprising:

a cannula having a lumen extending from a proximal end of the cannula to a distal end of the cannula and a marker outlet formed in a sidewall of the cannula proximal of the distal end of the cannula;

a distal tip for closing the distal end of the cannula;

an angled portion positioned adjacent to the marker exit;

a marker engagement member positioned in the lumen of the cannula, wherein at least a portion of the marker engagement member is positioned distal to the proximal end of the marker exit port; and

at least one marker disposed in the lumen of the cannula.

(2) The device of claim (1), wherein the angled portion and the marker engaging member comprise a single integral component.

(3) The device of item (1), wherein the beveled portion is integral with the marker engaging member and the distal tip.

(4) The device of item (1), wherein the distal tip, the beveled portion, and the marker engaging member comprise a single integral component.

(5) The device of claim (1), wherein the distal tip, the beveled portion, and the marker engagement member comprise a unitary molded component.

(6) The device of item (1), wherein the cannula comprises a thin-walled tube having a relative flexibility, and the marker engagement member comprises a relatively rigid member disposed in the lumen.

(7) The device of item (1), wherein the sleeve has a wall thickness (t), the marker engaging member having a thickness greater than the wall thickness (t) of the sleeve.

(8) The device of item (1), wherein the marker engaging member comprises a step of substantially uniform thickness over at least a portion of its axial length.

(9) The device of (8), wherein the marker engagement member comprises a tapered proximal end.

(10) The device of item (1), wherein the distal tip is relatively more radiopaque than the cannula.

(11) The device of item (10), wherein the distal tip, the beveled portion, and the marker-engaging member are relatively more radiopaque than the cannula.

(12) The device of item (11), wherein the distal tip, the beveled portion, and the marker engagement member comprise a radiopaque material.

(13) The device of item (12), wherein the distal tip, the beveled portion, and the marker engagement member are one integrally molded component comprising barium sulfate.

(14) The device of item (1), wherein the marker-engaging member extends along a bottom wall of the lumen generally opposite the marker outlet.

(15) The device of item (1), wherein the marker engagement is placed in the sleeve for strengthening the sleeve.

(16) A biopsy marker delivery device, comprising:

a cannula having a proximal end, a distal end, a lumen extending between the proximal and distal ends, and a marker exit port formed in a sidewall of the cannula;

a monolithic endpiece disposed in the distal end of the cannula and comprising:

a distal tip;

a beveled portion proximal to the distal tip and having a bevel extending from a distal end of the marker outlet;

a marker engagement member extending proximally from the ramped portion; at least one biopsy marker disposed in the lumen of the cannula.

Drawings

The invention is believed to be better understood by the following description of certain examples taken in conjunction with the accompanying drawings. In the drawings, wherein like reference numerals denote like elements, in which:

FIG. 1 shows a perspective view of a marker delivery device.

FIG. 2 shows a cross-sectional view of a distal portion of a marker delivery device according to the present invention.

FIG. 3 shows a marker being placed by the placer through a lateral tissue receiving port of the biopsy needle for marking the biopsy site.

Fig. 4 shows a generally planar titanium sheet having two relatively large lobes or ends separated by a narrow portion, which may be used to form a radiopaque marker element.

Fig. 5 shows a marker element formed in three dimensions from the planar sheet shown in fig. 4, such as by twisting two flaps in opposite directions as indicated by the arrows in fig. 5.

FIG. 6 shows an end view of the marker member of FIG. 5, the marker member having a generally x-shaped configuration when viewed end-on in FIG. 6.

FIG. 7 illustrates an assembly used in injection molding a unitary tip segment in the distal open end of a cannula to form the distal tip, beveled portion and marker junction of a marker delivery device according to one embodiment of the present invention.

Detailed Description

The following description of some examples of the invention should not be taken as limiting the scope of the invention. Other examples, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the present invention. It is also to be understood that there are various and contemplated aspects of the present invention that are within the scope of the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

Fig. 1 shows a marker delivery device 10 that includes an elongate outer sleeve 12, the sleeve 12 having a marker outlet, such as a side opening 14, formed near and proximal to the distal end of the sleeve 12.

The proximal end of the cannula 12 may be provided with a handle 16. A push rod 18 may be provided and the push rod 18 extends coaxially within the cannula 12 such that the push rod 18 is configured to be movable within the cannula 12 to move one or more markers through the side opening 14 (see fig. 2). The push rod 18 may be sufficiently rigid when compressed to push the marker out of the lumen of the cannula 12 through the side opening 14, but the push rod 18 is relatively flexible when bent. A plunger 20 may be provided at the proximal end of the pusher rod 18 for pushing the pusher rod 18 distally within the cannula 12 to place a marker out of the cannula 12.

The user may grasp the handle 16 with two fingers and push the plunger 20 with the thumb of the same hand so that the user may operate the marker delivery device 10 with one hand. A spring (not shown) or other component may also be provided on pusher bar 18 for biasing pusher bar 18 proximally relative to handle 16 and sleeve 12.

FIG. 2 illustrates a cross-sectional view of a distal portion of a marker delivery device 10 according to one embodiment of the present invention. Fig. 2 shows a biopsy marker 300 disposed in the lumen 15 of the cannula 12. The marker 300 may include: 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 made of any suitable metallic or non-metallic material. In one embodiment, the cannula 12 is formed from a thin-walled hollow tube made of a suitable medical grade plastic or polymer. One suitable material is a thermoplastic elastomer, such as polyether block amide (PEBA), such as the material known under the trade name PEBAX. The sleeve 12 may be made of PEBAX and is 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 lumen 15 of the cannula. The side opening 14 extends in the axial direction (direction parallel to the axis of the lumen 15) from an opening proximal end 14A to an opening distal end 14B, as shown in fig. 2.

The distal tip 22 extending from the distal end of the cannula 12 may be rounded as shown in fig. 2. Referring to fig. 2, in the marker delivery device of the present invention, the distal end of the cannula 12 may be closed by an integral tip 21, the tip 21 being formed at the distal end of the cannula 12, with a portion of the tip 21 extending into the lumen 15 of the cannula. The endpiece 21 can be a molded or cast component and can provide a combination of an integrally formed tip 22, an angled portion 210 with a bevel 212, and a marker engagement 240. The ramp 212 assists in guiding the marker 300 from the lumen 15 through the side opening 14. The marker engagement member 240 assists in retaining the marker 300 within the lumen 15 until the user desires to place the marker.

The marker engagement member 240 is disposed within the lumen 15 and at least a portion thereof is distal to the proximal end 14A of the side opening 14. Marker engagement member 240 may extend along a portion of the bottom wall of cannula 15 below opening 14, and marker engagement member 240 may be positioned to reinforce the portion of the cannula forming opening 14. For example, by disposing marker engagement 240 below opening 14, as shown in FIG. 2, marker engagement 240 may help strengthen the area where the wall of sleeve 12 is cut away to form opening 14.

In the embodiment shown in FIG. 2, the marker engagement member 240 extends from the proximal-most portion of the ramp 212 and does not extend proximally of the side opening 14. In other embodiments, however, a portion of marker engaging member 240 may extend proximal of opening 14.

In the embodiment shown in FIG. 2, the marker engaging member 240 is stepped with a generally uniform thickness T along its axial length, except for having a tapered proximal end 242. The tapered proximal end 242 may form an interior angle of about 45 degrees with the longitudinal axis of the lumen 15 (i.e., an interior angle with the horizontal line in fig. 2), and the chamfer 212 may form an interior angle of about 30 degrees with the longitudinal axis.

The thickness T may be greater than the wall thickness T of the sleeve 12, and in one embodiment, the thickness T is at least about twice the thickness T. In one embodiment, the thickness T may be between about 0.018 inches to about 0.040 inches and the wall thickness T may be between about 0.005 inches to about 0.008 inches. The inner diameter of the lumen 15 may be about 0.120 inches.

In the embodiment shown in fig. 2, the upward facing surface 244 (the surface facing the opening 14) of the marker engagement member 240 extends distally and contacts the ramp 212 such that there is no space or gap between the upward facing surface 244 and the ramp 212. Such an arrangement is advantageous in reducing the likelihood that the marker 300 will become caught between the marker engagement member and the angled portion as it moves past the marker engagement member.

According to one embodiment of the present invention, marker engaging member 240, angled portion 210, and/or tip 22 may be made of or include a material that is relatively more radiopaque than the wall of cannula 12. For example, when the marker engagement member 240, the angled portion 210, and the tip 22 are formed as an integral tip segment 21, the tip segment 21 may contain a radiopaque additive, such as barium sulfate. For example, the end segment 21 may be a PEBAX molded part in which about 20% by weight barium sulfate is added to the molten PEBAX molding compound.

The relatively more radiopaque marker engaging member 240, beveled portion 210 and tip 22 are useful in identifying the location of these components using radiographic methods. Also, in the case where the angled portion and/or the stepped portion of the marker-engaging member is positioned in association with the opening 14, the addition of radiopaque material may help determine the position of the opening, as well as the position of the marker 300 relative to the opening, before, during, or after placement of the marker.

The figures show the situation where only one marker is placed in the lumen 15. However, it should be understood that multiple markers may be provided in the marker delivery device 10, for example in an end-to-end configuration. These markers may be of the same size and shape, or alternatively of different sizes and/or shapes.

The cannula 12 is substantially transparent to visible light and X-rays, and the end segment 21 is substantially opaque to visible light and X-rays. If desired, a dye or other suitable colorant may be added to the liquid molding compound to color the end segment 21. For example, it may be desirable to provide different sized markers (e.g., length and/or diameter) for different biopsy procedures. For example, it may be desirable to provide a larger marker when taking a relatively larger biopsy sample and a smaller marker when taking a relatively smaller biopsy sample. The end segment 21 may be colored with one of a variety of colors to indicate the size of the marker disposed in the cannula. For example, if three marker sizes are provided, the endpiece 21 may be dyed one of three colors to determine the size of the marker disposed in the cannula of a particular marker device. The end segment 21 may also be colored to indicate the particular size (diameter or length) of biopsy needle that the marker delivery device is to be used with. Alternatively, multiple marker delivery devices may be packaged in a kit including marker delivery devices having different sized markers and correspondingly colored end segments.

As shown in fig. 3, the marker delivery device 10 may be used to place a marker to mark a specific site within a patient. A cannulated biopsy needle 1000 is shown in fig. 3. The illustrated biopsy needle 1000 has a closed distal end with a piercing tip 1002, and a lateral tissue receiving aperture 1014. The marker deployer 10 may be guided to the biopsy site by a biopsy needle 1000, which may be the same needle used to collect 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. A variety of such biopsy devices are disclosed in the various patents and patent applications cited and incorporated by reference, but other biopsy devices may also be used.

The distal end of the marker deployer 10 is shown disposed inside the biopsy needle 1000 in fig. 3. The biopsy needle 1000 may be placed in tissue and a biopsy sample may be taken through the opening 1014, thus providing a biopsy cavity near the opening 1014. The applier 10 may then be inserted into the proximal opening in the biopsy needle 1000 after a tissue sample is taken and moved proximally through the biopsy needle, while keeping the biopsy needle 1000 from being withdrawn from the patient's tissue. In fig. 3, the position of the biopsy needle 1000 and the marker placer 10 are arranged such that the opening 14 of the cannula 12 is substantially aligned with the opening 1014 of the biopsy needle 1000 both axially and circumferentially. And with the marker deployer and biopsy needle positioned at the biopsy site as described above, advancing the push rod 18 pushes the marker up the ramp 212, through the opening 14, and then through the opening 1014 and into the biopsy cavity.

Figures 4-6 illustrate radiopaque marker elements that may be used with the marker delivery device 10. Fig. 4 shows a generally planar shaped blank 310A, which is made of a radiopaque material, such as titanium, and may be cut or otherwise formed to include a relatively large first portion 312, a relatively large second portion 314, and a relatively narrow portion 316 connecting the first and second portions 312, 314. The blank 310A may include a first side 315 and a second side 317.

The first and second portions 312, 314 are shown as generally circular lobes, but other shapes may be used, such as square, rectangular, triangular, oval. To form a three-dimensional marker element 310 (such as that which may be disposed within bioabsorbable body 306 as shown in fig. 2), two petals 312 and 314 may be twisted in opposite directions about axis 318 as shown by the arrows in fig. 5. The two flaps 312 and 314 may be twisted so that the included angle 319 (shown in fig. 6) between them is between about 45 degrees and about 135 degrees. The resulting three-dimensional, radiopaque marker element 310 is generally x-shaped when viewed from one end, as shown in fig. 6. Because the substantially planar portions 312 and 314 are twisted and then do not lie in a plane with respect to each other, they can be more easily viewed from various directions (e.g., top, bottom, side, end, etc.) under a variety of imaging methods including X-ray. A three-dimensional marker element 310 as shown in fig. 5 and 6 may be inserted into the bioabsorbable body 306 (as in fig. 2), or otherwise carried by the body 306, to provide a marker 300 having a bioabsorbable body and a radiopaque marker element.

Fig. 7 shows an assembly that may be used to injection mold a unitary tip segment 21 in the distal end of the cannula 12. The assembly may include a mold portion 4000 having a mold cavity 4020 that includes a rounded surface 4021 (corresponding to the rounded, generally hemispherical tip 22 shown in fig. 2). As shown in fig. 7, sleeve 12 may be placed within a mold cavity 4020. A core member 5000 having a generally cylindrical outer surface may be placed within the interior cavity of the cannula 12 as shown in fig. 7. The member 5000 can have end surfaces 5212, 5244, and 5242 corresponding to the ramped surface 212, the stepped surface 244, and the tapered end surface 242. A molten mixture comprising PEBAX and radiopaque additive is then injected into the mold cavity 4020 such that the end section 21 is formed at the distal opening of the cannula 12.

Embodiments of the devices disclosed herein are typically designed for single use, but may be designed for multiple uses. After the marker is formed and inserted into the marker placer, the biopsy device may be sterilized. The device may be placed in a package such as a plastic or pet bag.

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

While various embodiments of the present invention have been illustrated and described, other modifications to the methods and systems described herein can be made by those skilled in the art with appropriate modifications without departing from the scope of the invention. A number of these possible modifications have been mentioned herein, and others will occur to those skilled in the art. For example, the above detailed examples, embodiments, geometric designs, materials, dimensions, proportions, steps, etc. are illustrative and not required. The scope of the invention should, therefore, be determined by the appended claims and not construed as limited to the details of construction and operation described and illustrated in the specification and drawings.

Claims (4)

1. A biopsy marker delivery device comprising:

a cannula having a lumen extending from a proximal end of the cannula to a distal end of the cannula and a marker outlet formed in a sidewall of the cannula proximal of the distal end of the cannula, the cannula being made of a material that is transmissive to visible light and X-rays, wherein the cannula defines a longitudinal axis extending therethrough;

a distal tip for closing a distal end of the cannula, made of a radiopaque material, wherein the cannula extends distally beyond a proximal portion of the distal tip and a proximal portion of the distal tip is located within the cannula;

an angled portion positioned adjacent to the marker exit, wherein the angled portion defines a first interior angle relative to the longitudinal axis and the angled portion forms a first plane;

a marker engagement member positioned within the lumen of the cannula, wherein at least a portion of the marker engagement member is positioned distal to the proximal end of the marker exit port, wherein the marker engagement member comprises a tapered proximal end defining a second interior angle relative to the longitudinal axis, wherein the tapered proximal end forms a second plane, the marker engagement member extending proximally from the angled portion, the marker engagement member extending proximally along a sidewall of the cannula, the marker engagement member having a thickness that is at least twice a thickness of the sidewall of the cannula; and

at least one marker disposed in the lumen of the cannula.

2. The device of claim 1, wherein the cannula comprises a thin-walled tube having a relative flexibility, and the marker engagement member comprises a relatively rigid member disposed in the lumen.

3. The device of claim 1, wherein the marker engaging member comprises a step over at least a portion of its axial length, the step being substantially uniform in thickness.

4. The device of claim 1, wherein the distal tip is a molded or cast component.