Specimen Marking Clip

Abstract

A specimen marking clip is provided that is adapted to selectively attach to tissue inside of a patient and corresponding tissue that has been excised from the patient for analysis. Sutures may be associated with the clips to help ensure correct in vivo and ex vivo sample orientation. In vivo clips may remain in the patient's body if necessary.

Claims

1. A clip adapted to selectively interconnect to tissue, comprising: a first leg having a proximal end with a plurality of inwardly-extending teeth and a distal end; a second leg having a proximal end with a plurality of inwardly-extending teeth and a distal end; wherein the first leg and the second leg are curved, and wherein the proximal end of the first leg and the proximal end of the second end define an apex, wherein the first and second legs extend away from the apex in the same direction; and a tapered portion on the first leg or the second leg, wherein the tapered portion is configured to facilitate selective leg deformation.

2. The clip of claim 1, further comprising a suture interconnected to at least one of the first leg or the second leg.

3. The clip of claim 1, wherein at least one of the suture or clip includes identifying indicia.

4. The clip of claim 3, wherein the identifying indicia comprises at least one of a surface texture, a micro-engraving, x-ray markings, microchip technology, nanotech technology, RFID chips, and a coating.

5. The clip of claim 1, wherein the distal ends of the first leg and the second end are spaced such that a distance between the distal ends is less than a length of the first leg or the second leg.

6. A clip adapted to selectively interconnect to tissue, comprising: a first leg having a proximal end and a distal end; a second leg having a proximal end and a distal end; wherein the first leg and the second leg are curved, and wherein the proximal end of the first leg and the proximal end of the second end define an apex, wherein the first and second legs extend away from the apex in the same direction; and a tapered portion on the first leg or the second leg, wherein the tapered portion is configured to facilitate selective leg deformation.

7. The clip of claim 6, further comprising a suture interconnected to at least one of the first leg or the second leg.

8. The clip of claim 7, wherein the clip and suture are of the same color.

9. The clip of claim 7, wherein at least one of the suture or clip includes identifying indicia.

10. The clip of claim 9, wherein the identifying indicia comprises at least one of a surface texture, a micro-engraving, x-ray markings, microchip technology, nanotech technology, RFID chips, and a coating.

11. The clip of claim 6, wherein the distal ends of the first leg and the second end are spaced such that a distance between the distal ends is less than a length of the first leg or the second leg.

12. A method of marking a tissue specimen removed from a patient, comprising: identifying an area of interest in the patient's body; defining the outer boundary of the area of interest; defining a margin having a perimeter spaced from the outer boundary of the area of interest; attaching a tissue sample clip between the area of interest and the margin; attaching an in vivo clip outside the margin and opposite to the tissue sample clip; creating an incision around the area of interest that generally corresponds with the margin, the incision defining a boundary of a tissue sample; removing the tissue sample and interconnected tissue sample clip; and maintaining the in vivo clip within the patient's body.

13. The method of claim 12, further comprising interconnecting a deep tissue in vivo clip in a cavity that remains in the patient's body when the tissue sample is removed, and interconnecting a corresponding deep tissue sample clip to the tissue sample.

14. The method of claim 13, wherein the tissue sample clip and the in vivo clip are of a first color, and the deep tissue in vivo clip and deep sample clip are of a second color.

15. The method of claim 12, further comprising: analyzing the tissue sample and identifying a second area of interest; using the clips to map the second area of interest to a corresponding location in the patient's body; defining a second margin around the corresponding location in the patient's body; attaching a second tissue sample clip between the corresponding location in the patient's body and the second margin; attaching a second in vivo clip outside the second margin and opposite the second tissue sample clip; and creating a second incision around the corresponding location in the patient's body, generally corresponding with the second margin, the second incision defining a boundary of a second tissue sample.

16. The method of claim 12, wherein the tissue sample clip and in vivo clip each comprise: a first leg having a proximal end and a distal end; a second leg having a proximal end and a distal end; wherein the first leg and the second leg are curved, and wherein the proximal end of the first leg and the proximal end of the second end define an apex, wherein the first and second legs extend away from the apex in the same direction; and a tapered portion on the first leg or the second leg, wherein the tapered portion is configured to facilitate selective leg deformation.

17. The method of claim 16, further comprising a suture interconnected to at least one of the first leg or the second leg.

18. The method of claim 17, wherein the tissue sample clip, the suture associated with the tissue sample clip, the in vivo clip, and the suture associated with the in vivo clip are of the same color.

19. The method of claim 17, wherein the tissue sample clip and the in vivo clip are of the same color, the suture associated with the tissue sample clip has a first identifying indicia, and the suture associated with the in vivo clip has a second identifying indicia.

20. The method of claim 19, wherein the first indicia and second indicia are different.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0025] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and together with the general description of the invention given above and the detailed description of the drawings given below, serve to explain the principles of these inventions.

[0026] FIG. 1 is a perspective view of the clip of one embodiment of the present invention.

[0027] FIG. 2 is a front elevation view of the clip shown in FIG. 1.

[0028] FIG. 3 is a detailed view of FIG. 2.

[0029] FIG. 4 is a detailed view of FIG. 2

[0030] FIG. 5 the top plan view of the clip shown in FIG. 1.

[0031] FIG. 6 is a detailed view of FIG. 5.

[0032] FIG. 7 is a right elevation view of the clip shown in FIG. 1.

[0033] FIG. 8 is a perspective view of the clip system of one embodiment of the present invention.

[0034] FIG. 9 is a front elevation view of the clip system illustrating the removal of one clip from a housing.

[0035] FIG. 10 is a representation showing the first step in removing a tissue sample from the body.

[0036] FIG. 11 is a representation showing the incorporation of clips to an in vivo side and a margin side of the tissue sample.

[0037] FIG. 12 is a representation showing removal of the tissue sample from a patient.

[0038] FIG. 13 is a representation showing the removed sample and the incorporation of a deep margin clip in vivo.

[0039] FIG. 14 illustrates both sides of the removed sample.

[0040] FIG. 15 is a representation of mapping sample's area concerned to a corresponding in vivo location.

[0041] FIG. 16 is a representation showing a defined second margin that surrounds a new area of concern.

[0042] FIG. 17 is a representation showing a removed second sample and the incorporation of a second deep margin clip.

[0043] FIG. 18 shows an example of a report concerning the clips of one embodiment of the present invention.

[0044] The following component list and associated numbering found in the drawings is provided to assist in the understanding of one embodiment of the present invention: [0045] # Component [0046] 2 Clip [0047] 6 First leg [0048] 10 Second leg [0049] 14 Proximal end [0050] 18 First leg distal end [0051] 22 Second leg distal end [0052] 26 Teeth [0053] 30 Tapered portion [0054] 34 Suture hole [0055] 38 Clip system [0056] 42 Base [0057] 46 Housing [0058] 48 Adhesive [0059] 50 Suture [0060] 54 Applier [0061] 58 Margin [0062] 62 Periphery [0063] 66 Mass [0064] 70 Sample [0065] 74 In vivo tissue [0066] 78 Cavity [0067] 82 Underside [0068] 86 New area of concern [0069] 90 New margin [0070] 94 Report [0071] R Red [0072] G Green [0073] B Blue [0074] Y Yellow [0075] GR Gray [0076] P Purple [0077] i In vivo side [0078] s Sample side [0079] n New

[0080] It should be understood that the drawings are not necessarily to scale. In certain instances, details that are not necessary for an understanding of the invention or that render other details difficult to perceive may have been omitted. It should be understood, of course, that the invention is not necessarily limited to the particular embodiments illustrated herein.

DETAILED DESCRIPTION

[0081] FIGS. 1-7 show clip 2 of one embodiment of the present invention comprised of a first leg 6 and the second leg 10. The first leg 6 and the second leg 10 have operatively interconnected proximal ends 14 and corresponding distal ends 18 and 22. In one embodiment, the proximal ends are interconnected by a living hinge, a hinge, or a deformable member. The deformable members may be of a thickness less than that of the legs to allow the distal ends to be urged towards each other. In some embodiments, the deformable portions are spaced from the leg's proximal ends. Further, those of ordinary skill in the art will appreciate that the legs are inherently deformable. In operation, pressure applied to the outside surface of the first and/or second leg will selectively deform the clip 2 and move the distal end of the first leg 18 and the distal end of the second leg 22 towards each other, generally in the direction of Arrow A. One of ordinary skill in the art will appreciate that the dimensions shown in FIGS. 2-4 and 6 are applicable to one embodiment of the present invention and, thus, are for reference only.

[0082] FIGS. 2 and 3 highlight the nature of the inner surfaces of the first and second legs of one embodiment, wherein teeth 26 are provided to facilitate clip grasping onto a tissue sample taken from a patient's body and/or in vivos tissue associated with the excised sample, which will be apparent upon review of FIGS. 11-17. In operation, biasing of the legs towards each other will bring corresponding teeth 26 into close proximity with tissue therebetween.

[0083] FIG. 4 shows another portion of the clip adjacent to the proximal end 14. Here, a tapered portion 30 is provided that accommodates a suture hole 34. The suture hole 34 receives a suture as shown in FIG. 8 that helps identify the clip. The tapered section 30 may also facilitate movement of the distal ends towards each other.

[0084] FIG. 8 shows a clip system 38 of one embodiment of the present invention having a base 42 with interconnected housing 46 that accommodates a plurality of clips 2 and associated sutures 50. For example, adhesive 48 can be used to secure the base 42 to a tray. In this example, colored suture pairs consisting of margin side and in vivo side are shown, wherein the colors denote predefined approximate locations of clip placement, which will be described in further detail below. As mentioned above, suture color may denote margin side or in vivo side or match the clip color. One of ordinary skill in the art will appreciate that although solid colors are alluded to herein, other identification methods, such as stripes or striations, may be employed without departing from the scope of the invention.

[0085] FIG. 9 illustrates the removal of a clip 2 from the housing. Here, the housing includes cavities that selectively receive and securely maintain the clips within the housing. This feature ensures clip sterility and decreases the chances of the incorrect clip being removed because the physician must make a concerted effort to remove a desired clip from the housing. An applier 54 is used to grasp and angulate the clip 2 a predetermined amount, in the example shown about 20° from horizontal, to initiate clip removal. Thereafter, the clip 2 remains held by the applier 54 in an orientation suitable for interconnection to tissue.

[0086] FIGS. 10 and 11 illustrate pre-sample removal from the patient. The first step in the operation is to define a margin 58 a predetermined distance from a periphery 62 of a mass 66, i.e., the area of concern being biopsied. The margin 58, thus, defines a sample 70 that will be removed from the patient. Before removal, however, a plurality of clips are associated with the sample 70 and in vivo tissue 74 associated with the sample. According to one embodiment, color-coded clips 2Rs, 2Bs, 2Gs, and 2Ys indicate locations on the sample (s), and corresponding color-coded clips 2Ri, 2Bi, 2Gi, and 2Yi indicate mirrored, in vivo (i) locations. One of skill in the art will appreciate the sample side clips 2s and the in vivo side clips 2i may have the same color or otherwise be identified as a pair with predefined indicia (e.g., A and 1, B and 2, etc.), integrated RFID technology, x-ray markers, etc.

[0087] Color-coated sutures can be provided on the sample side 50Rs, 50Bs, 50Gs, and 50Ys and the in vivo side 50Ri, 50Bi, 50Gi, and 50Yi. Suture color or marking method may correspond with the interconnected clip color or marking method. Alternatively, suture color may depend on whether the clip is on the sample side 50s or the in vivo side 50i. In FIG. 11, the sutures are of the same color. In one embodiment, red clamps/sutures indicate an anterior sample location. Similarly, green, blue, purple, and yellow clamps/sutures represent inferior, superior, posterior, and deep locations, respectively. However, other embodiments may feature various other color-coding schemes.

[0088] In operation, a surgeon will attach one marking clip 2s to the margin 58 associated with a predefined portion of the specimen mass 66, and a second marking clip 2i to tissue 74 surrounding the specimen mass 66, outside the margin 58. Subsequently, an incision is made along the margin 58, which is shown in FIGS. 10 and 12. The result is a mirror image marking of the two areas—sample and in vivo tissue. The paired clips allow pathologists to quickly match the orientation of the specimen (ex-vivo) relative to a cavity 78 created (in-vivo). FIGS. 13 and 14 show a deep-tissue clip 2Pi placed within the cavity 78, wherein the corresponding sample clip 2Ps is placed on the underside 82 of the sample.

[0089] FIGS. 15-17 illustrate one aspect of some embodiments of the present invention that helps a pathologist identify a new area of concern 86. The new area of concern 86 defines a new margin 90, in the example shown, associated with the green clip 2Gs. Accordingly, the surgeon can create an accurate new margin 90 because the corresponding in vivo green clip 2Gi can be quickly located. A series of new clips 2Rni, 2Rns, 2Bni, 2Bns, 2Gni, 2Gns, 2Yni, 2Yns, 2Pni, and 2Pns (not shown) can then be associated with a new tissue sample (not shown) and the new cavity 78n. As one of ordinary skill in the art will appreciate, the process of defining new margins will continue until the pathologist is satisfied that all areas of concern have been excised.

[0090] FIG. 18 is a representation of a report 94 associated with the biopsy or mass removal procedure. The report 94 is designed to provide a historical record of the entire surgical procedure. If the area of concern becomes an issue in the future, the nature of the in vivo clips can be assessed and compared with the prior procedure. For example, if the area of concern shifts to a new clip set, the pathology of the mass may be assessed and amended to provide a new strategy for addressing the medical issue. The report 94 will provide a detailed description of color and clip location for immediate or future use.

[0091] Exemplary characteristics of embodiments of the present invention have been described. However, to avoid unnecessarily obscuring embodiments of the present invention, the preceding description may omit several known apparatus, methods, systems, structures, and/or devices one of ordinary skill in the art would understand are commonly included with the embodiments of the present invention. Such omissions are not to be construed as a limitation of the scope of the claimed invention. Specific details are set forth to provide an understanding of some embodiments of the present invention. It should, however, be appreciated that embodiments of the present invention may be practiced in a variety of ways beyond the specific detail set forth herein.

[0092] Modifications and alterations of the various embodiments of the present invention described herein will occur to those skilled in the art. It is to be expressly understood that such modifications and alterations are within the scope and spirit of the present invention, as set forth in the following claims. Further, it is to be understood that the invention(s) described herein is not limited in its application to the details of construction and the arrangement of components set forth in the preceding description or illustrated in the drawings. That is, the embodiments of the invention described herein are capable of being practiced or of being carried out in various ways. The scope of the various embodiments described herein is indicated by the following claims rather than by the foregoing description. And all changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope. It is intended to obtain rights which include alternative embodiments to the extent permitted, including alternate, interchangeable and/or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and/or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0093] The foregoing disclosure is not intended to limit the invention to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the invention are grouped together in one or more embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed inventions require more features than expressly recited. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the invention. Further, the embodiments of the present invention described herein include components, methods, processes, systems, and/or apparatus substantially as depicted and described herein, including various sub-combinations and subsets thereof. Accordingly, one of skill in the art will appreciate that would be possible to provide for some features of the embodiments of the present invention without providing others. Stated differently, any one or more of the aspects, features, elements, means, or embodiments as disclosed herein may be combined with any one or more other aspects, features, elements, means, or embodiments as disclosed herein.