Patent Application
20220401180
Embodiments of the present invention are generally related to medical devices, more particularly, surgical specimen margin marking and orientation devices and methods.
Surgical specimen margin marking to define sample orientation for endoscopic, robotic, laparoscopic, or other surgery types where body tissue is removed is critical for pathological diagnosis, tumor excision, etc. Specimen margin orientation marking is often needed for endoscopic excision of a tumor. In such an example, the tumor is removed and forwarded to a pathologist for evaluation. The pathologist subsequently performs an analysis to identify malignancy in the sample. A surgeon may then direct additional tissue to be excised, the orientation of which is critical for proper and accurate excision.
The current surgical specimen margin marking technique uses ink to mark an excised specimen. One conventional method comprises marking a specimen mass with a line to differentiate it from tissue surrounding an excised specimen mass. The ink mark may be placed on the specimen mass at a “12:00 o'clock” position. This approach is inaccurate and subject to error if the orientation of the specimen is changed (e.g., dropped, manipulated, etc.) before marking. The surgeon, staff, or pathologist examining the specimen mass may also mistakenly manipulate the removed specimen mass before marking, or there may be miscommunication between surgeons and pathologists related to orientation. Further, it may be difficult to find the ink marks and compare them to those on the removed specimen mass. An alternative approach includes placing a reference suture in the specimen at the 12:00 o'clock position. However, this approach is equally subject to error.
Accordingly, an improved surgical specimen margin orientation marking method is desired. The systems and methods described herein allow for mirror image marking of multiple types of surgical specimens covering a multitude of surgeries and disciplines.
It is one aspect of some embodiments of the present invention to provide a marking clip configured to selectively engage tissue. The marking clip of one embodiment includes first and second legs extending from a common interconnection point. Opposite ends of the legs are spaced but can be selectively deformed toward each other when an external force is applied to the outside surfaces of the legs. In operation, tissue is placed between the legs and the clip is deformed, thereby pinching the tissue. In one embodiment, portions of the legs include teeth or a roughened/knurled surface that enhances grip. The legs and/or the common interconnection point may be more malleable to facilitate clip deformation.
A biopsied area of interest, e.g., a possibly cancerous mass, is removed from a patient's body along with a predefined amount of surrounding tissue. “Margin,” as used herein, is the peripheral edge of the removed sample tissue, defined by the incision created to remove the tissue sample. Those of ordinary skill in the art will appreciate that accurate analysis, which is needed to ensure all abnormal tissue has been removed from the patient's body, is important and relies on maintaining tissue sample orientation. That is, understanding the orientation of the tissue sample relative to the excision location helps the surgeon and pathologist identify additional areas of concern on the tissue sample so that the surgeon can remove corresponding tissue from the patient.
Accordingly, it is another aspect of some embodiments to provide a clip that maintains the in vivo and ex vivo orientation of an excised tissue sample. More specifically, each clip of some embodiments of the present invention is of a unique color assigned to a predefined tissue sample attachment location on the margin. To further ensure proper post-excision tissue sample orientation, embodiments of the present invention interconnect like color clips to corresponding margin locations within the patient's body. One of ordinary skill in the art will appreciate that other means can be used to match ex vivo and in vivo clips.
Those of ordinary skill in the art will appreciate that other identification techniques may be used to define clip location on the tissue sample and in vivo. One embodiment, for example, employs colored sutures interconnected to otherwise indistinct clips. Other embodiments contemplate colored clips having sutures of matching colors extending therefrom. Alternatively, sutures positioned on one side of a margin (e.g., tissue sample side) may have one color/indicia and sutures positioned on the opposite side of the margin (e.g., in vivo side) may have a second color/indicia, thereby allowing quick identification of which suture to attach relative to the margin. Sutures may be striped with clip color to indicate their intended attachment location—in vivo or tissue sample side.
The clips may be made of material that suits the tissue to which they are to be attached—muscle, ligament, skin, fatty tissue, etc. The clips can be of any size and shape and made of any suitable material. For example, the clip's material of manufacture may be stiff, compliant, malleable, etc., to suit the surgeon's desires or to accommodate tissue character. In one embodiment, the clips are made of titanium per ASTM F67 Grade 1. The clips may possess a surface texture or other types of tactile or enhanced visual identification means. Further, the clips may be micro-engraved or X-ray marked with identifying information. The sutures also may employ microchip technology, nanotech technology, RFID technology, specialized coatings, frequency emitting devices that allow current or future-developed 3-dimensional, computer, or virtual reality medical imaging modalities to locate and identify sutures in the body. These marking methods may be provided in combination or in various sub-combinations.
The sutures of some embodiments of the present invention are stiff, compliant, malleable, etc., to suit the surgeon's desires. The sutures of one embodiment are made of PTFE coated braided polyester, meeting all requirements established by the United States Pharmacopedia (U.S.P) for nonabsorbable surgical sutures. The sutures may possess a surface texture or other types of tactile or enhanced visual identification means. Further, the sutures may be micro-engraved or X-ray identifiable with identifying information. The sutures also may employ microchip technology, nanotech technology, RFID technology, specialized coatings, frequency emitting devices that allow current or future-developed 3-dimensional, computer, or virtual reality medical imaging modalities to locate and identify sutures in the body. These marking methods may be provided in combination or in various sub-combinations.
In one example, the clips and/or sutures are configured to selectively deliver medication to the patient. That is, the aspects of various embodiments of the present invention may also allow for the utilization of adjuvant therapies that employ selective and/or controlled application of drugs, radiation, etc. In one embodiment, the clips/sutures left in the patient's body employ treatment means, e.g., drug and/or radiation delivery systems. The clips/sutures of some embodiments employ drug and/or radiation delivery systems or are constructed at least partially from such materials that provide treatment over an extended period of time. For example, all or a portion(s) of the clips/sutures may comprise a drug-infused co-polymer (i.e., a polymer drug conjugate) manufactured of polylactide-polyglycolide similar to that found in dissolvable sutures.
The suture or clip may have diagnostic qualities, wherein a characteristic change occurs when conditions around the specimen mass change. For example, tumor growth, tissue DNA/RNA change, etc., would initiate a color change in the clips/sutures. The clips/sutures may also possess the ability to transmit diagnostic information outside the patient's body.
In another example, the clips and/or sutures are configured to indicate special information, e.g., the distance between clips or sutures, the distance between a clip and the specimen mass within the body, etc., which may assist in ascertaining mass growth. One of ordinary skill in the art will appreciate that the clips may employ other types of indicia alone or in combination with corresponding indicia of the sutures without departing from the scope of the embodiments of the present invention. Further, the characteristics of the clips and/or sutures do not have to match identically across the margin boundary; the primary concern is that one must later be able to orient the mass relative to the area of excision, which will be described below correctly.
The surgeon may implement the clip/suture combination as an effective tool for manipulating tissues, which is more efficient than attaching a handle to an otherwise slippery surface. For example, the sutures and/or clips described herein can facilitate traction, counter traction, specimen mass control during robotic and laparoscopic cases, and lift the specimen mass into extraction bags. The clips/sutures contemplated herein may also be used to facilitate wound closure or as anchor points for implants.
The Summary of the Invention is neither intended nor should it be construed as being representative of the full extent and scope of the present invention. That is, these and other aspects and advantages will be apparent from the disclosure of the invention(s) described herein. Further, the above-described embodiments, aspects, objectives, and configurations are neither complete nor exhaustive. As will be appreciated, other embodiments of the invention are possible using, alone or in combination, one or more of the features set forth above or described below. Moreover, references made herein to “the present invention” or aspects thereof should be understood to mean certain embodiments of the present invention and should not necessarily be construed as limiting all embodiments to a particular description. The present invention is set forth in various levels of detail in the Summary of the Invention as well as in the attached drawings and the Detailed Description and no limitation as to the scope of the present invention is intended by either the inclusion or non-inclusion of elements, components, etc. in this Summary of the Invention. Additional aspects of the present invention will become more readily apparent from the Detailed Description, particularly when taken together with the drawings.
The above-described benefits, embodiments, and/or characterizations are not necessarily complete or exhaustive, and in particular, as to the patentable subject matter disclosed herein. Other benefits, embodiments, and/or characterizations of the present invention are possible utilizing, alone or in combination, as set forth above and/or described in the accompanying figures and/or in the description herein below.
The phrases “at least one,” “one or more,” and “and/or,” as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least one of A, B and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and/or C” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together.
Unless otherwise indicated, all numbers expressing quantities, dimensions, conditions, and so forth used in the specification and drawing figures are to be understood as being approximations which may be modified in all instances as required for a particular application of the novel assembly and method described herein.
The term “a” or “an” entity, as used herein, refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein.
The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Accordingly, the terms “including,” “comprising,” or “having” and variations thereof can be used interchangeably herein.
It shall be understood that the term “means” as used herein shall be given its broadest possible interpretation in accordance with 35 U.S.C., Section 112(f). Accordingly, a claim incorporating the term “means” shall cover all structures, materials, or acts set forth herein, and all of the equivalents thereof. Further, the structures, materials, or acts and the equivalents thereof shall include all those described in the Summary, Brief Description of the Drawings, Detailed Description and in the appended drawing figures.
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.
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:
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.
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
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
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.
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.
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.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 63/213,168, filed Jun. 21, 2021, the entirety of which is incorporated by reference herein. The Appendix included is incorporated by reference herein. This application is related to pending U.S. patent application Ser. No. 16/711,653, filed Dec. 12, 2019, which is a continuation-in-part of abandoned U.S. patent application Ser. No. 16/162,017, filed Oct. 16, 2018, which is a continuation-in-part of U.S. patent application Ser. No. 15/139,012, filed Apr. 26, 2016, now U.S. Pat. No. 10,111,727, issued Oct. 30, 2018, which claims the benefit of U.S. Provisional Patent Application Ser. No. 62/162,035, filed May 15, 2015, the entire disclosures of which are incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 63213168 | Jun 2021 | US |
