WO2017095618A1 - Radiopaque neurosurgical micro-patties and apparatus with radiopaque neurosurgical micro-patties for brain mapping - Google Patents

Abstract

An apparatus used in connection with mapping a brain during a neurosurgical procedure. The apparatus includes a plurality of micro-patties and a card stock. The micro- patties are configured to map the brain, with at least one micro-patty including an inner layer, a first external layer disposed on top of the inner layer, and at least one radiopaque marker integrated with the inner layer or the first external layer. The cardstock is configured to affix or receive the plurality of micro-patties in at least one arrangement in connection with the neurosurgical procedure.

Description

RADIOPAQUE NEUROSURGICAL MICRO-PATTIES AND APPARATUS WITH RADIOPAQUE NEUROSURGICAL MICRO-PATTIES FOR BRAIN MAPPING

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

The present application claims priority to U.S. Provisional Patent Application Serial No. 62/261,096, filed on November 30, 2015, the contents of which are incorporated herein by reference in their entirety.

BACKGROUND

Field of Technology

The present application relates generally to markers for brain mapping. More specifically, the present application is directed to radiopaque neurosurgical micro-patties, and apparatus with radiopaque neurosurgical micro-patties, for brain mapping.

Brief Description of Related Art

A craniotomy is a commonly performed neurosurgical procedure (e.g., operation or surgery) that can be performed to biopsy or resect a tumor, stop bleeding, remove a blood clot, or clip a blood vessel in the brain. In performing a craniotomy, a neurosurgeon generally makes an incision in the scalp, removes a piece of the skull, and exposes the brain. Neurosurgical brain mapping or simply brain mapping can be used during a neurosurgical procedure to map the brain.

For example, resecting a tumor located in the motor or language cortex of the brain requires a neurosurgeon to map out and further determine which areas of the brain are safe to resect without causing harm or neurological deficit to the patient. Electrical stimulation and the placement of alpha and numeric markers on the brain are commonly used to accomplish the aforementioned tasks.

These markers are miniscule and are generally made out of paper days in advance of the neurosurgical procedure. More specifically, twenty (20) letters and twenty (20) numbers are typically typed on a sheet of paper, and the paper is later sterilized. The day of the neurosurgical procedure, the sheet of paper is dispensed to the surgical field and prepared for use by a surgical technician. More specifically, the letters and numbers are cut out of the sheet of paper, forming individual markers that are typically placed on a folded towel of the sterile field. Thereafter, during the brain mapping portion of the neurosurgical procedure, the neurosurgeon selects the markers that he or she wishes to use. Due to their light weight and ability to stick to wet surfaces, these tiny markers are difficult to keep track of on the sterile field. If a marker is missing, there is no way of knowing for sure whether the marker was left in the brain.

The current technique of using a sheet of paper, sheet of latex, or another material, with typed or handwritten letter and numbers is flawed because the resulting miniscule markers can be easily lost and also difficult to recover. More specifically, the markers can get wet, become illegible, stick to other items on the sterile field, and tear or even stick to each other. Moreover, the markers are not x-ray detectable. Due to their size and the aforementioned difficulties, these markers are not readily detectable, which can lead to serious safety concerns for the patient, including but not limited to a foreign object retained in the brain. In accordance with the current technique, the tiny markers are counted on the sterile field at the start and also at the end of a neurosurgical procedure, which ensures that all of the markers used have been recovered. However, the current technique does not facilitate the identification at a glance of how many markers are on the sterile field and/or how many markers are on the patient's brain, at any given time during the neurosurgical procedure. It is thus desirable to provide markers and apparatus with markers that can be inexpensively manufactured, as well as easily used, identified, and detected during neurosurgical procedures, thereby resolving the aforementioned safety concerns, among others.

SUMMARY The present application is directed to radiopaque neurosurgical micro-patties, and apparatus with radiopaque neurosurgical micro-patties, for brain mapping.

The apparatus is used in connection with mapping a brain during a neurosurgical procedure. The apparatus includes a plurality of micro-patties and a cardstock. The micro-patties are configured to map the brain, with at least one micro-patty including an inner layer, a first external layer disposed on top of the inner layer, and at least one radiopaque marker integrated with the inner layer or the external layer. The at least one micro-patty can also include a second external layer disposed on bottom of the inner layer. The cardstock is configured to affix or receive the plurality of micro-patties in at least one arrangement in connection with the neurosurgical procedure.

In various embodiments, the at least one radiopaque marker can be disposed in the inner layer, between the inner layer and the first external layer, between the inner layer and the second external layer, or on top of the first external layer. The inner layer can be made of gauze, cotton, cottonoid, rayon, or one or more combinations thereof. In some embodiments, the radiopaque marker can be threaded through the inner layer.

The first external layer can be made from a polymer. The second external layer can also be made from a polymer. In various embodiments, the polymer can be rubber, nylon, vinyl, polystyrene, polyethylene, polypropylene, polyvinyl butyral, silicone, or one or more combinations thereof.

Moreover, an arrangement on the cardstock can include a plurality of locations labeled with first indicators, and the plurality of micro-patties that can be having second indicators can be affixed to or received into pockets associated with the locations with corresponding first indicators. The first indicators and the second indicators can include a plurality of numbers, a plurality of letters, or a combination of the numbers and the letters. In various embodiments, the radiopaque markers can be disposed so as to form the second indicators.

The cardstock can include a perforated line at least partially along its width. A sterile container can include the cardstock folded about the perforated line and the plurality of micro-patties. In some embodiments, the micro-patties can be affixed to the cardstock. In other embodiments, the micro-patties can be received in pockets affixed to the cardstock. In yet other embodiments, the micro-patties can be arranged in a sheet that can be provided with the cardstock.

BRIEF DESCRIPTION OF THE DRAWINGS

Some embodiments or aspects are illustrated by way of example and not limitation in the figures of the accompanying drawings in which:

FIG. 1 illustrates an example cardstock labeled to affix radiopaque neurosurgical micro-patties used in brain mapping of neurosurgical procedures;

FIG. 2 illustrates an example radiopaque neurosurgical micro-patty that can be removably affixed to a location of the cardstock; FIGS. 3A-3C illustrate several example cross-sections of the example radiopaque neurosurgical micro-patty illustrated in FIG. 2;

FIG. 4 illustrates the example cardstock illustrated in FIG. 1 to which there are affixed respective radiopaque neurosurgical micro-patties such as illustrated in FIGS. 2-3C;

FIG. 5 illustrates a folded and packaged cardstock illustrated in FIG. 1 affixed with respective micro-patties illustrated in FIG. 4;

FIG. 6 illustrates a sheet of micro-patties as illustrated in FIGS. 2-3C; and

FIG. 7 illustrates a folded and packaged cardstock illustrated in FIG. 1 provided with a sheet of respective micro-patties illustrated in FIG. 6.

DETAILED DESCRIPTION FIG. 1 illustrates an example cardstock 100 labeled to affix radiopaque neurosurgical micro-patties used in brain mapping of neurosurgical procedures. The cardstock can be made from a material that provides sufficient strength, flexibility, and resiliency to hold affixed radiopaque neurosurgical micro-patties in a sterile field. For example, the cardstock 100 can be made of paper, pasteboard, paperboard, or cardboard, which are durable, thin, and yet flexible for holding radiopaque neurosurgical micro-patties. In various embodiments, the cardstock 100 can also be made of metal (e.g., stainless steel, titanium, cobalt, nickel), plastic (e.g., polyvinyl chloride, polyethylene, polypropylene, polystyrene, polyetheretherketone), alloys of materials, and/or various combinations of materials. The plastics can be hard or pliable, transparent, semi-transparent, or not transparent. As illustrated in FIG. 1, the cardstock 100 has length 102 and width 104 dimensions, and a perforated line 106 that extends at least partially along the width 104. The perforated line 106 divides the cardstock 100 into a first portion 108 and a second portion 116, which can be folded about the perforated line 106 to produce a smaller form factor that can be easily packaged for distribution. The portions 108, 116 can be equal or different in length. The dimensions 102, 104 should be sufficient to affix a plurality of radiopaque neurosurgical micro-patties used in brain mapping. An example neurosurgical micro-patty is described hereinbelow with reference to FIG. 2. As an example, the dimensions 102, 104 can be 10 inches by 3 inches, respectively. Other dimensions are of course possible depending on the number and sizes of the radiopaque neurosurgical micro-patties that are to be affixed to the cardstock 100.

Moreover, the cardstock 100 includes a plurality of locations, generally indicated as 110, 112, 118, 120, to which respective radiopaque neurosurgical micro-patties can be affixed or in connection with which the neurosurgical micro-patties can be received. In some embodiments, these locations are individually labeled or printed with respective indicators 114, and will affix or receive respectively labeled or printed radiopaque neurosurgical micro- patties used in brain mapping. The indicators 114 can be letters, numbers, as well as other characters. For example, the indicators 114 can be alphanumeric, such as letters A-T, and numbers 1-20. Additionally or alternatively, others letters, numbers, and/or characters can of course be used to label the locations 110, 112, 118, 120. The locations 110, 112, 118, 120 can be distributed on the cardstock 100 in a plurality of arrangements. In some embodiments, the locations can be evenly spaced along the length of the cardstock 100, at the top and bottom as illustrated in FIG. 1. For example, the letters A-T can be evenly distributed along the top, and the numbers 1-20 can be evenly distributed along the bottom, as respective plurality of locations. In this regard, letters A- J and numbers 1-10 can be distributed respectively along the top and bottom of the first portion 108 of the cardstock 100, and letters K-T and numbers 11-20 can be evenly distributed along the top and bottom of the second portion 116 of the cardstock 100.

In some embodiments, the respective plurality of locations 110, 112, 118, 120, can be indicated by a plurality of respective pockets (not shown), which can receive respectively labeled or printed radiopaque neurosurgical micro-patties used in brain mapping. The pockets can be affixed to the cardstock 100 at these respective locations. More specifically, the pockets can be transparent so that the indicators 114 (letters and the numbers) set forth on the cardstock 100 can be seen through the pockets. Alternately or additionally, the pockets can also be individually labeled or printed with respective indicators 114, which can thus receive respectively labeled or printed radiopaque neurosurgical micro-patties.

Moreover, the cardstock 100 includes locations 111 and 119, which are generally open locations. In some embodiments, these locations can be used to affix or receive one or more additional radiopaque neurosurgical micro-patties, as will be described hereinbelow with reference to FIG. 2. In other embodiments, these locations can simply hold one or more of the radiopaque neurosurgical micro-patties after their use, e.g., after completion of the neurosurgical procedure.

The design, size, and dimensions of the cardstock 100, including the perforated line 106, as well as the labeled indicators 114, can be modified as may be desired for certain sterile fields and/or neurosurgical procedures. The cardstock 100 with the plurality of locations, whether including pockets or not, as labeled with respective indicators, can affix or receive individually-marked respective neurosurgical micro-patties so that a surgeon, circulator, and/or surgical technician could determine at first glance the markers that are on the sterile field, the markers that are in use on the patient's brain, and/or the markers that might be missing, whether at the start or at the end of the neurosurgical procedure.

FIG. 2 illustrates an example radiopaque neurosurgical micro-patty 200 that can be removably affixed to a location 110 of the cardstock 100. With reference to FIGS. 1 and 2, the micro-patty 200 can be affixed to or received in connection with the location 110 indicated with an indicator 114 that corresponds to an indicator 206 on the micro-patty 200. The micro-patty 200 can be made from a material that provides strength, durability, and detectability so that it can be used in brain mapping. More specifically, micro-patty 200 will mitigate tearing upon becoming wet, the alphanumeric lettering and/or numbering on the micro-patty 200 will remain legible for accountability, and the micro-patty 200 is detectable for removability from the brain after the neurosurgical procedure, such as via use of x-ray. Other micro-patties to be affixed or received can be provided and can thus correspond to the remaining marked locations 110, 112, 118, 120 of the cardstock 100.

For example, a plurality of individually labeled micro-patties can be provided to correspond to a respective plurality of locations individually labeled in connection with the cardstock 100. In some embodiments, there are provided forty (40) labeled radiopaque neurosurgical micro-patties to be used in brain mapping, which are affixed to the respectively-labeled locations on the cardstock 100 or received within respective pockets associated with these locations of the cardstock 100.

As illustrated in FIG. 2, the patty 200 has length 202 and width 204 dimensions, indicator 206, and radiopaque marker 208.

The dimensions 202, 204 are such that can be used in brain mapping during neurosurgical procedures. In some embodiments, the micro-patty 200 is square with dimensions 202, 204 that are respectively ¼ inch by ¼ inch. In one or more other embodiments, each of the dimensions 102, 104 can be larger or smaller, providing larger or smaller square or rectangular micro-patties. Moreover, the one or more of the micro-patties can have different shapes (e.g., circle, oval, star) or a combined shape that has multiple constituent shapes (e.g., rectangle top and bottom edges with circular or oval left/and right edges).

In this regard, differently-dimensioned and/or differently-shaped micro-patties can of course be provided and used with respectively labeled locations on the cardstock 100. For example, locations 111, 119 can be used to affix or receive in respective pockets such radiopaque neurosurgical micro-patties. While various dimensions and/or shapes of the micro-patties patties 200 can be used, as described hereinabove, it is important to note that the dimensions and/or shapes should be small enough such that the radiopaque neurosurgical micro-patties 200 can be used in small cranial locations, and indicators 206 should be large enough in order to be legible (e.g., the indicator 206 should identifiable with a naked eye). More specifically, each of the micro- patties 200 is labeled with an indicator 206, which can be a letter, number, and/or another character, such as a letter from A-T or a number from 1-20. It should be noted that the micro-patty 200 can be labeled with the indicator 206 on top and/or on bottom of the micro- patty 200. With reference to FIGS. 1 and 2, the micro-patty 200 can be affixed to location 110 that has the label 114 ("A") corresponding to the label 206 ("A") on the micro-patty 200. As described with reference to the cardstock 100, the indicator 206 of the micro-patty 200 can similarly be a letter, number, and/or another character. For example, the indicator 206 can be alphanumeric, such as a letter from A-T or a number from 1-20. Another letter, number, and/or character can of course be used. As aforementioned, the indicator 206 of the micro- patty 200 corresponds to the indicator 114 of the location 100 on the cardstock 100. In similar fashion, other micro-patties (not shown) can be labeled with indicators that correspond to other respectively-labeled locations 110, 112, 116, 118 of the cardstock 100. The indicator 206 can be printed, painted, and/or embossed on the micro-patty 200. An example radiopaque marker 208 is illustrated by a symbolic broken line. It should be noted that the radiopaque marker 208 can include one or more radiopaque markers, which can be the same or different and which can further be arranged in one or more configurations. The one or more radiopaque markers enable a neurosurgeon or surgical technician to easily identify whether the micro-patty 200 was left in the brain of the patient during a neurosurgical procedure. Several radiopaque markers and configurations of the markers will be described in greater detail hereinbelow with reference to FIGS. 3A-3C.

FIG. 3A illustrates an example cross-section of the radiopaque neurosurgical micro- patty 200 illustrated in FIG. 2. The micro-patty 200 includes a middle layer 302, external non- layers 304, 306, indicator 206, and a radiopaque marker 308. In various embodiments, the external layers 304, 306 can be adhered to the middle layer 302 by bonding or gluing.

The middle layer 302 can be gauze, cotton, cottonoid, surgical dressing, or knitted fabric (e.g., cotton, rayon, and blends of various materials). Various other alternatives can of course be used for the middle layer 302.

The external layers 304, 306 can be made from a polymer that can enable the micro- patty 200 to removably stick to the brain tissue, but that does not allow the micro-patty 200 to adhere to the brain tissue. For example, the polymer can include rubber, nylon, polyvinyl chloride (vinyl), polystyrene, polyethylene, polypropylene, polyvinyl butyral (PVB), and silicone). Other materials can of course be used as long as the micro-patty 200 can removably stick to the brain tissue but does not adhere to the brain tissue.

As illustrated in FIG. 3A, the indicator 206 is provided on both external layers 304, 306, such that the micro-patty 200 can be visible to the neurosurgeon, circulator, and/or surgical technician on the sterile field and on the patient's brain using any one of the external layers 304, 306. However, the indicator 206 can also be provided on only one of the external layers 304, 306.

In some embodiments, the micro-patty 200 can be made from Telfa™ by Covidien LP, a non-adherent dressing that includes a middle gauze layer and external non-adherent layers. Such a micro-patty 200 is labeled with an indicator 206 (e.g., via printing, painting, embossing), and made radiopaque by receiving the one or more radiopaque markers 308.

More specifically, the radiopaque marker 308 can be one or more radiopaque strings that can extend (e.g., weave) through the middle layer 302, and/or one or more strings disposed between the middle layer 302 and external layers 304, 306. A radiopaque string can extend through the middle layer 302, and can be adhered to middle layer 302, e.g., via bonding, glue, etcetera. Similarly, radiopaque strings disposed between the middle layer 302 and external layers 304, 306 can be adhered to the middle layer 302 and/or to the external layers 304, 306 via bonding, glue, etcetera. It should be noted that one or more of the strings can extend through the middle layer 302 and/or be disposed between the middle layer 302 and external layers 304, 306 in a shape that contours the shape of the indicator 206 on the micro-patty 200, e.g., letter "A" as illustrated in FIG. 2. This facilitates identification (e.g., via x-ray) of a particular micro-patty 200 in the brain of a patient. The radiopaque markers can also be one or more differently- shaped markers (e.g., square, circular, or combination of shapes, etc.) that can be disposed in the middle layer 302 and/or between the middle layer 302 and the external layers 304, 306. For example, a first radiopaque marker can be a shape that contours the shape of the indicator 206 on the micro-patty 200, and a second radiopaque marker can be another shape, e.g., a circle, square or other shape, about the first radiopaque marker.

In some embodiments, Telfa™ or a similar material is cut into a plurality of pieces, e.g., ¼ inch by ¼ inch. The pieces are sized and dimensioned in order to provide sufficient space on the brain for brain mapping. One or more radiopaque strings are extended though the pieces, e.g., radiopaque strings are extended or threaded through the middle layer of the pieces. Each of the pieces is labeled with a number, letter, and/or character as described hereinabove (e.g., selected from 1-20 and A-T, using printing, stamping, embossing, etcetera), forming micro-patties 200. The cardstock 100, which is correspondingly labeled (e.g., A-T and 1-20), then affixes or receives each of the micro-patties 200 as described herein. While Telfa™ is optional, it can be useful because it does not adhere to brain tissue.

It is also recognized that an alternative material could be used and still provide the function of non-adherence to brain tissue.

FIG. 3B illustrates an example cross-section of the radiopaque neurosurgical micro- patty 200 illustrated in FIG. 2. The micro-patty 200 includes a middle radiopaque layer 310, and external non-adherent layers 304, 306. In various embodiments, the external layers 304,

306 can be adhered to the middle layer 310 by bonding or gluing.

As illustrated in FIG. 3B, the indicator 206 is provided on both external layers 304, 306, such that the micro-patty 200 can be visible to the neurosurgeon, circulator, and/or surgical technician on the sterile field and on the patient's brain using any one of the external layers 304, 306. However, the indicator 206 can also be provided on only one of the external layers 304, 306.

The middle radiopaque layer 310 can be one or more radiopaque markers (e.g., radiopaque strings) that can be disposed between and adhered to the external layers 304, 306, e.g., via bonding, glue, etcetera. As already described hereinabove, the one or more of the strings can be disposed between the external layers 304, 306 in a shape that contours the shape of the indicator 206 on the micro-patty 200, e.g., letter "A" as illustrated in FIG. 2. This facilitates identification (e.g., via x-ray) of a particular micro-patty 200 in the brain of a patient. The radiopaque markers can also be one or more differently-shaped markers (e.g., square, circular, or combination of shapes, etc.) that can be disposed between the external layers 304, 306. For example, a first radiopaque indicator can be a shape that contours the shape of the indicator 206 on the micro-patty 200, and a second radiopaque indicator can be another shape, e.g., a circle, square or other shape, about the first radiopaque indicator. FIG. 3C illustrates an example cross-section of the radiopaque neurosurgical micro- patty 200 illustrated in FIG. 2. The micro-patty 200 includes an inner low-adhesion layer 312, an external non-adherent layer 304 (or layer 306), and one or more radiopaque markers 314. In various embodiments, the external layer 304 can be adhered to the inner layer 302 by bonding or gluing. The inner layer 312 can be a low-adhesion gauze, cotton, cottonoid, rayon, or one or more combinations or blends thereof. The inner layer 312 is thin, pliable, strong, and provides low adhesion to brain tissue so that it could be easily removed after use during a neurosurgical procedure. In one example, the inner layer 312 can be made of Delicot^®. It is of course noted that various other alternatives can be used for the inner layer 312. In some embodiments, the inner layer 312 can also include radiopaque marker 308, which can be one or more radiopaque strings that can extend through the inner layer 312, and/or one or more strings disposed between the inner layer 312 and external layer 304. Moreover, a second external layer 306 can also be provided on the opposing side of the inner layer 312, as described with reference to FIGS. 3 A and 3B.

An example radiopaque marker 314 is disposed atop the external layer 304, and also second external layer 306, if it is provided. The radiopaque marker 314 can be a radiopaque ink that is disposed atop the external layer 304, and atop the second external layer 306, if it is provided. The ink can be dried or cured on the external layer 304 in a desired shape. For example, in some embodiments, the radiopaque marker 314 can be shaped to form the indicator 206, such that the indicator 206 can be read by the naked eye and yet also be visible via an x-ray. Alternatively or in addition, a radiopaque marker 314 can also be differently- shaped

(e.g., square, circular, or combination of shapes, etc.) that can be disposed in relation to the indicator 206. For example, a first radiopaque marker can be shaped to form the indicator 206 on the external layer 304 of the micro-patty 200, while a second radiopaque marker can be shaped as another shape, e.g., a circle, square or other shape about the first radiopaque indicator. Similarly, external layer 306, if provided, can also receive a first radiopaque marker and a second radiopaque marker, as described above with reference to external layer 304.

FIG. 4 illustrates the example cardstock 100 illustrated in FIG. 1 to which there are affixed respective radiopaque neurosurgical micro-patties 200, such as illustrated in FIGS. 2 and 3A-3C.

More specifically, individually-labeled micro-patties 200 are affixed to individually- labeled corresponding locations 110, 112, 118, 120, or received within respective pockets associated with the aforementioned locations of the cardstock 100. For example, micro-patty 200 that is labeled with indicator 206 ("A") is affixed to or received in connection with a location 110 that is correspondingly-labeled with indicator 114 ("A"). Other micro-patties are affixed or received in a similar fashion with respect to locations 110, 112, 166, 120, and/or locations 111, 119, of the cardstock 100. The neurosurgical micro-patties 200 can be removably affixed to the cardstock 100 using a non-toxic adhesive, glue, or static cling, or can be received within the aforementioned pockets. In some embodiments, it is also possible that the respective micro-patties 200 can be provided separately in a free floating fashion, e.g., not affixed to the cardstock 100. In some other embodiments, the micro-patties 200 can also be provided separately in a sheet with perforations, such that respective micro-patties can be easily separated for use during a neurosurgical procedure, as described in greater detail hereinbelow with reference to FIG. 6. In still other embodiments, score lines or other indicia can be provided on the sheet, such that respective micro-patties can be easily cut out for use during a neurosurgical procedure. FIG. 5 illustrates a cardstock 100 as illustrated in FIG. 4 affixed with respective micro-patties 200 as illustrated in FIGS. 2-3C, folded and sealed as a brain-mapping apparatus 500.

More specifically, the apparatus 500 includes the cardstock 100 that is affixed with or receives respective micro-patties 200 as described hereinabove. The cardstock 100 is folded about perforated line 106 into compact form-factor. The apparatus 500 is sealed in container

502 for distribution. More specifically, the apparatus 500 is packaged in a sterile container 502 for use in brain mapping during a neurosurgical procedure. The sterile container 502 can be a peel pack that can be opened to the sterile field.

The apparatus 500 can thus be dispensed and the sterile container 502 opened to the sterile field, with one or more of the neurosurgical micro-patties 200 disposed in connection with the cardstock 100 and ready to be used by the neurosurgeon in brain mapping.

FIG. 6 illustrates a sheet 604 of respective micro-patties 200 as illustrated in FIGS. 2- 3C sealed as a brain-mapping apparatus 600.

As illustrated in FIG. 6, the apparatus 600 includes micro-patties 200 provided in the sheet 604 with a plurality of perforations, such that the respective micro-patties can be easily detached or separated for use during a neurosurgical procedure. Instead of the perforations, score lines or other indicia can be provided on the sheet 604, such that the respective micro- patties 200 can be easily detached or separated, e.g., cut out, for use during a neurosurgical procedure.

The apparatus 600 is sealed in container 602 for distribution. More specifically, the apparatus 600 is packaged in a sterile container 602 for use in brain mapping during a neurosurgical procedure. The sterile container 602 can be a peel pack that can be opened to the sterile field. Instead of the sheet 604, it is also possible that the respective micro-patties 200 can be provided separately in a free floating fashion in the container 602.

The apparatus 600 can thus be dispensed and the sterile container 602 opened to the sterile field, with one or more of the neurosurgical micro-patties 200 disposed on the sterile field, and ready to be used by the neurosurgeon in brain mapping.

FIG. 7 illustrates a cardstock 100 as illustrated in FIG. 4 provided with respective micro-patties 200 as a sheet 604 illustrated in FIG. 6, folded and sealed as a brain-mapping apparatus 700.

More specifically, the apparatus 700 includes the cardstock 100 that is affixed with or receives the sheet 604 of micro-patties 200 as described hereinabove. The cardstock 100 is folded about perforated line 106 into compact form-factor. For example, the sheet 604 can be initially affixed to one of the locations 111, 119, or simply received between the locations 111, 119 in the compact form-factor. The apparatus 500 is sealed in container 502 for distribution. More specifically, the apparatus 500 is packaged in a sterile container 502 for use in brain mapping. The sterile container 502 can be a peel pack that can be opened to the sterile field.

The apparatus 500 can thus be dispensed and the sterile container 502 opened to the sterile field, with one or more of the neurosurgical micro-patties 200 separated from the sheet 604 and disposed in connection with the cardstock 100. At this point, the micro-patties 200 are ready to be used by the neurosurgeon in brain mapping.

In view of the foregoing, the micro-patties 200 as described would save time from having to cut out and label individual paper markers, which that can be easily lost on the sterile field, as is the case in present practice using current techniques. Moreover, the paper markers currently used in brain mapping are not radiopaque so that if the markers are not accounted for during a neurosurgical procedure, they can be accidentally left in the brain. However, the neurosurgical micro-patties 200 described hereinabove would help to eliminate the risk of a patient leaving the operating room with a foreign object in the patient's brain after neurosurgery. If one of the micro-patties 200 is missing at the end of neurosurgery, an x-ray can be used to determine whether or not the missing micro-patty was left in the brain of the patient.

As described hereinabove, the alphanumeric micro-patties 200, which incorporate several layers, carry more weight than paper markers and thus make it easier to track the micro-patties 200 on the sterile field. In addition, the micro-patties 200 are radiopaque, which enables their detection using an x-ray, and which reduces aforementioned difficulties of the current techniques that can cause serious health consequences for the patient. More specifically, the micro-patties 200 are a safe alternative to using small pieces of paper in that they are x-ray detectable and eliminate the risk that they are left in the brain of a patient. The cardstock 100 is affixed with or receives micro-patties 200, and is folded and sealed in a compact sterile container 502, which can be opened on the sterile field for easy visualization of the micro-patties 200. The cardstock 100 that is affixed with or receives micro-patties 200 allows a neurosurgeon, circulator, and/or surgical technician to readily identify at first glance how many micro-patties 200 are on the sterile field and how many micro-patties 200 are on the patient's brain tissue. Moreover, the micro-patties 200 enable the neurosurgeon to clearly see each letter, number, and/or character used in brain mapping.

More specifically, the sterile container 502 is opened to reveal the cardstock 100. The cardstock 100 is unfolded on the sterile field, and all micro-patties are counted prior to incision in the patient, e.g., by the surgical technician or circulator. During the neurosurgical procedure, the micro-patties 200 are handed to the neurosurgeon for use during brain mapping of the neurosurgical procedure, such as a craniotomy. At the end of the

neurosurgical procedure, the micro-patties 200 will be counted again. If a certain micro- patty 200 is missing at the end of the procedure, the radiopaque marker 208, 308, 310, 314 helps the neurosurgical team to identify whether the micro-patty 200 was left in the brain of the patient. An x-ray of the patient' s head can be obtained to determine if the micro-patty 200 was left behind. If the unaccounted micro-patty 200 is visible on x-ray, the micro-patty 200 can be retrieved prior to closing the incision. This provides enhanced patient safety and helps to mitigate or eliminate the risk of micro-patties being left unknowingly in the patient's brain.

In similar fashion, the sterile container 602 can be opened to the sterile field to reveal the sheet 604 of micro-patties 200. The micro-patties 200 can be dispensed onto the sterile field and counted by the surgical technician and/or circulator prior to incision in the patient. During the neurosurgical procedure, the micro-patties 200 are similarly handed to the neurosurgeon for use in the brain mapping of the neurosurgical procedure. At the end of the neurosurgical procedure, the micro-patties 200 will be counted again. If a certain micro- patty 200 is missing at the end of the procedure, an x-ray of the patient's head can be obtained to determine if the micro-patty 200 was left inside the brain. If the unaccounted micro-patty 200 is visible on x-ray, the micro-patty 200 can be retrieved prior to closing the wound. This provides enhanced patient safety and helps to mitigate or eliminate the risk of micro-patties being left unknowingly in the brain.

Thus, radiopaque neurosurgical micro-patties and apparatus with radiopaque neurosurgical micro-patties for brain mapping have been described. Although specific example embodiments have been described, it will be evident that various modifications and changes may be made to these embodiments without departing from the broader spirit and scope of the invention.

Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. The accompanying drawings that form a part hereof, show by way of illustration, and not of limitation, specific embodiments in which the subject matter may be practiced. The embodiments shown are described in sufficient detail to enable those skilled in the art to practice the teachings disclosed herein. Other embodiments may be utilized and derived therefrom, such that structural and logical substitutions and changes may be made without departing from the scope of this application. The foregoing detailed description, therefore, is not to be taken in a limiting sense, and the scope of various embodiments is defined only by the appended claims, along with the full range of equivalents to which such claims are entitled.

Although specific embodiments have been shown and described herein, it should be appreciated that any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This application is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.

The Abstract is provided to comply with 37 C.F.R. § 1.72(b) and will allow the reader to quickly ascertain the nature of the technical disclosure of this application. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims.

In the foregoing detailed description, various features may be grouped together in a single embodiment for the purpose of streamlining the disclosure of this application. This method of disclosure is not to be interpreted as reflecting that the claimed embodiments have more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed

embodiment.

Moreover, it is contemplated that the features or components of various embodiments described herein can be combined into different combinations that are not explicitly enumerated in the foregoing detailed description and that such combinations can similarly stand on their own as separate example embodiments that can be claimed.

Claims

Claims:

1. An apparatus used in connection with mapping a brain during a neurosurgical procedure, the apparatus comprising: a plurality of micro-patties configured to map the brain, at least one micro-patty including an inner layer, a first external layer disposed on top of the inner layer, and at least one radiopaque marker integrated with the inner layer or the first external layer; and a cardstock configured to affix or receive the plurality of micro-patties in at least one arrangement in connection with the neurosurgical procedure.

2. The apparatus of claim 1, wherein the at least one radiopaque marker is disposed in the inner layer.

3. The apparatus of claim 1, wherein the at least one radiopaque marker is disposed between the inner layer and the first external layer.

4. The apparatus of claim 1, further comprising a second external layer disposed on bottom of the inner layer.

5. The apparatus of claim 4, wherein the at least one radiopaque marker is disposed between the inner layer and the second external layer.

6. The apparatus of claim 1, wherein the at least one radiopaque marker is disposed on top of the first external layer.

7. The apparatus of claim 1, wherein the inner layer is made of gauze, cotton, cottonoid, rayon, or one or more combinations thereof.

8. The apparatus of claim 1, wherein the radiopaque marker is threaded through the inner layer.

9. The apparatus of claim 1, wherein the first external layer is made from a polymer.

10. The apparatus of claim 9, wherein the polymer is rubber, nylon, vinyl, polystyrene, polyethylene, polypropylene, polyvinyl butyral, silicone, or one or more combinations thereof.

11. The apparatus of claim 1, wherein an arrangement on the cardstock includes a plurality of locations labeled with first indicators, and the plurality of micro-patties having second indicators are affixed to or received into pockets associated with the locations with corresponding first indicators.

12. The apparatus of claim 11, wherein the first indicators and the second indicators include a plurality of numbers, a plurality of letters, or a combination of the numbers and the letters.

13. The apparatus of claim 11, wherein radiopaque markers are disposed so as to form the second indicators.

14. The apparatus of claim 1, wherein the cardstock includes a perforated line at least partially along its width.

15. The apparatus of claim 1, further comprising a sterile container that includes the cardstock and the plurality of micro-patties, the cardstock folded about the perforated line.

16. The apparatus of claim 15, wherein the plurality of micro-patties are affixed to the cardstock.

17. The apparatus of claim 15, wherein the plurality of micro-patties are received in pockets affixed to the cardstock.

18. The apparatus of claim 15, wherein the plurality of micro-patties are arranged in a sheet provided with the cardstock.