System and method for attaching a biopsy collecting device to a spectroscopy system

A biopsy collecting device includes a needle unit comprising a biopsy specimen. Also, the biopsy collecting device includes an activator unit operatively coupled to the needle unit and including a channel at a bottom surface of the activator unit, wherein the channel is configured to detachably couple the biopsy collecting device to an attaching unit of a spectroscopy system.

BACKGROUND

Embodiments of the present disclosure relate generally to optical spectroscopy, and more particularly to a system and a method for quantifying an amount of diagnostic tissue and determining types of tissues within the excised biopsy specimen using optical spectroscopy.

In many fields of medicine, tissue classification is widely used to aid diagnosis in a patient. For example, when a patient presents with a suspicious deep tissue lesion, such as those identified during a diagnostic CT scan, the typical workup includes tissue classification to assist in diagnosis and stratify patients for further testing.

Among the existing techniques, core needle biopsy (CNB) is increasingly used as a minimally invasive method to acquire a representative sample of a deep tissue lesion. Typically in CNB, needle intervention is used for taking tissue biopsies and submitting it to pathology to determine a diagnosis. Compared to surgical or excisional biopsy, CNB procedure is less invasive, less expensive, faster, minimizes deformity, leaves little or no scarring and requires a shorter time for recovery. Also, CNB may obviate the need for surgery in a patient with benign lesions and also reduce the number of surgical procedures performed in the patient.

In general, the CNB is a common procedure used to obtain a biopsy specimen that includes a physical sample of a tissue site. Further, the biopsy specimen may be analyzed in a pathology laboratory using histopathological techniques to determine whether the tissue sample is cancerous. However, one of the problems in CNB is that approximately 15-20% of biopsy specimens/samples are non-diagnostic, which yields too little tissue for a definitive diagnosis. As a result, in some cases, the CNB procedure may be repeated to obtain a viable amount of biopsy specimen/sample from the patient, which may create further complications to the patient. For example, piercing the needle repeatedly into lungs to obtain the biopsy specimen may result in a collapsed lung.

Moreover, the amount of diagnostic tissue in the biopsy specimen may limit the number and types of tests available to the pathologist several days following the biopsy procedure, potentially resulting in a delayed diagnosis and increased risk to the patient. Since the advent of new molecular pathology tests requires a larger amount of viable cancer tissue than conventional histopathology, this problem is likely to increase. Thus, there is a need for an improved method and system for quantifying the amount of diagnostic tissue and determining types of tissues within the excised biopsy specimen.

BRIEF DESCRIPTION

In accordance with one embodiment described herein, a biopsy collecting device includes a needle unit comprising a biopsy specimen. Also, the biopsy collecting device includes an activator unit operatively coupled to the needle unit and comprising a channel at a bottom surface of the activator unit, wherein the channel is configured to detachably couple the biopsy collecting device to an attaching unit of a spectroscopy system.

In accordance with a further aspect of the present disclosure, a method for holding a biopsy collecting device includes collecting, by a needle unit, a biopsy specimen from a patient. Also, the method includes detachably coupling a female stepped-groove of an activator unit with a male stepped-groove of an attaching unit of a spectroscopy system so as to couple the biopsy collecting device to the attaching unit of a spectroscopy system.

DETAILED DESCRIPTION

As will be described in detail hereinafter, various embodiments of exemplary structures and methods for diagnosing tissue are presented. By employing the methods and the various embodiments of the system described hereinafter, the amount of diagnostic tissue and types of tissues in an excised biopsy specimen is determined without removing the biopsy specimen from the biopsy needle or the biopsy collecting device.

Turning now to the drawings, and referring toFIG. 1, a spectroscopy system for diagnosing tissue, in accordance with aspects of the present disclosure, is depicted. The spectroscopy system100may be used to determine an amount of diagnostic tissue and types of tissues present in an excised biopsy specimen. More specifically, the biopsy specimen may include one or more tissue samples that are classified into one or more tissue classes, which in turn aids in determining a quantity and/or a quality of the diagnostic tissue in the biopsy specimen. In one example, the one or more tissue classes may include a normal tissue class and an abnormal tissue class. The normal tissue class is referred to as a class of tissue samples having no cancerous tissues, such as benign tissue or blood, while the abnormal tissue class is referred to as a class of tissue samples having cancerous tissues, including malignant or necrotic tumor, or other diseased tissue such as fibrosis. Also, the spectroscopy system100may be used to characterize the biopsy specimen in a biopsy needle or a biopsy collecting device immediately after excision. It is to be noted that the biopsy specimen may be referred to as a physical sample of a region in a patient. In one example, the biopsy specimen may include at least a normal tissue and/or a cancerous tissue of a patient.

In accordance with one embodiment, the spectroscopy system100includes an illumination subsystem102, a fixation subsystem104, and a detection subsystem106. The illumination subsystem102is configured to emit an illumination light towards the biopsy specimen. The illumination light may be in a range from about 200 nm to about 1100 nm. As depicted inFIG. 1, the illumination subsystem102includes a light source108and a guiding unit110that is coupled to the light source108. In one example, the light source108may include a deuterium tungsten halogen source that is configured to emit a broadband light or a narrowband light towards the biopsy specimen. Further, the guiding unit110may include optical fibers and lenses that are used for guiding the emitted illumination light towards the biopsy specimen. In one embodiment, the guiding unit110may include a plurality of optical fibers that are used to deliver the emitted illumination light at multiple locations along the biopsy specimen.

In a presently contemplated configuration, the fixation subsystem104is configured to position the biopsy specimen across the illumination light that is emitted by the illumination subsystem102. As depicted inFIG. 1, the fixation subsystem104includes an attaching unit114that is configured to hold a biopsy collecting device112having the biopsy specimen. Particularly, the biopsy collecting device112may include an activator unit and a needle unit. A portion of the needle unit may be pierced into the patient towards a sample/tissue site to obtain the biopsy specimen. Thereafter, the biopsy collecting device112may be fastened to the attaching unit114that provides an interface between the biopsy collecting device112and the detection subsystem106.

In addition, the attaching unit114is used for positioning the biopsy collecting device112at a predetermined position and/or angle in the spectroscopy system100so that the illumination light may scan the biopsy specimen present in the needle unit. More specifically, the attaching unit114may be used for precisely positioning at least the needle unit relative to the illumination light while scanning the biopsy specimen. In one example, the attaching unit114may include one or more actuators that are employed for moving the biopsy collecting device112in a forward or backward direction with respect to an illumination path. The aspect of positioning the biopsy specimen across the illumination light is explained in greater detail with reference toFIG. 6.

Furthermore, the detection subsystem106is coupled to the fixation subsystem104and aligned with the illumination subsystem102for determining the diagnostic tissue in the biopsy specimen. The detection modality may be based on a variety of optical detection methods including but not limited to, diffuse optical spectroscopy, fluorescence spectroscopy, optical coherence tomography, Raman spectroscopy, or combinations thereof. In one exemplary embodiment, the detection subsystem uses diffuse optical spectroscopy for determining the diagnostic tissue in the biopsy specimen.

As depicted inFIG. 1, the detection subsystem106includes a guiding unit122, a detecting unit116, and a processing unit118. The guiding unit122may include optical fibers and lenses that are used for guiding the light comprising an attenuated illumination light and/or a re-emitted light from the biopsy specimen. In one embodiment, the guiding unit122may include a plurality of optical fibers that are used to guide the attenuated illumination light and/or the re-emitted light towards the detecting unit116. Further, the detecting unit116is used for generating an electrical signal corresponding to the attenuated illumination light and/or the re-emitted light from the biopsy specimen. Particularly, the detecting unit116includes one or more optical detectors that are aligned with the illumination path so as to receive the illumination light emitted by the illumination subsystem102and the light re-emitted from the biopsy specimen via the guiding unit122. The received light may be attenuated by one or more molecules in the biopsy specimen. More specifically, the molecules in the biopsy specimen may absorb, scatter, and/or attenuate the illumination light while passing through the biopsy specimen. This in turn causes transmission losses at various wavelengths in spectra of the illumination light. It is to be noted that the illumination light with such transmission losses may also be referred to as the attenuated illumination light. In one embodiment, the received light may be comprised of attenuated illumination light with transmission losses at various wavelengths, which may include information on the absorbance of molecules comprising the tissue, the inhomogeneity of the tissue refractive index, and the secondary light re-emitted by molecules due to fluorescence and/or Raman scattering phenomena. Also, it may be noted that the received and emitted illumination light paths may be in more than one direction. In one example, the illumination path may be orthogonal or at an oblique angle, e.g., 45 degrees, to the detected light path. Further, the detected light is converted to a corresponding electrical signal.

In addition, the processing unit118that is coupled to the detecting unit116may receive the electrical signal representing the received light. Further, the received electrical signal is processed to determine the diagnostic tissue in the biopsy specimen. Particularly, the spectrum of the received light may be analyzed to classify tissues into one or more tissue types, which in turn used to classify the tissue sample into at least one of the normal tissue class and the abnormal tissue class. Thereafter, the classified tissue sample is used to determine the quantity and the quality of the diagnostic tissue in the biopsy specimen. Also, the processing unit118may display the classified tissue types and the tissue sample in one or more forms on a display unit120that is coupled to the processing unit118. The aspect of processing the spectrum of the received light and displaying the classified tissue types is explained in greater detail with reference toFIG. 7.

After completion of the analysis, the biopsy specimen may be removed from the biopsy collecting device and transferred to a tissue fixation medium, e.g., formalin, for pathology. Thus, by using the exemplary spectroscopy system100, the diagnostic tissue within the excised biopsy specimen is determined without removing the biopsy specimen from the biopsy needle or the biopsy collecting device. Also, conducting analysis directly in the biopsy needle or the biopsy collecting device may minimize stress on the biopsy specimen/sample and impact on workflow, prior to transferring the biopsy specimen/sample for histopathology or cytopathology. In one embodiment, the biopsy collecting device may include a tissue collecting chamber or a tissue container that is used for collecting the tissue from the biopsy needle. Further, this tissue may be positioned across the illumination path of the spectroscopy system for further analysis, classification, and/or quantification of the tissue.

Referring toFIG. 2, an illustration of a needle unit comprising a biopsy specimen, in accordance with aspects of the present disclosure, is depicted. For ease of understanding, the needle unit200is described with reference to the components ofFIG. 1. It is to be noted that the needle unit200may be considered as a part or a component of the biopsy collecting device. As appreciated, the needle unit200may be pierced into a patient towards a desired tissue or sample site to obtain the biopsy specimen202from the patient. As depicted inFIG. 2, the needle unit200includes an outer sheath, which is known as a cannula204and an inner sheath, which is known as a stylet206. The stylet206may be configured to extend or retract from the cannula204. Further, the stylet206may have a collection area208for collecting the biopsy specimen202from the patient.

Moreover, upon collecting the biopsy specimen202from the patient, the biopsy collecting device having the needle unit200may be fastened to the attaching unit114. In one embodiment, the stylet206may be extended or retracted to position the biopsy specimen202across an illumination path210. Also, in another embodiment, the stylet206may be extended or retracted so that the illumination light may scan the biopsy specimen202at multiple locations. The aspect of fastening the needle unit200and scanning the biopsy specimen202is explained in greater detail with reference toFIG. 4.

FIG. 3is a diagrammatical representation of a top view of a biopsy collecting device, in accordance with aspects of the present disclosure. Also,FIG. 4is a diagrammatical representation of a bottom view of the biopsy collecting device, in accordance with aspects of the present disclosure. Reference numeral300may be representative of the biopsy collecting device112ofFIG. 1. The biopsy collecting device300includes a needle unit302and an activator unit304. The needle unit302may be similar to the needle unit200ofFIG. 2. The activator unit304is coupled to a rear end of the needle unit302and is configured to extend or retract the stylet206relative to the cannula204.

Further, the activator unit304includes a channel306at a bottom surface308of the activator unit304. The channel304is configured to detachably couple the biopsy collecting device300to the attaching unit114of the spectroscopy system100. Particularly, the channel306includes a female stepped-groove310on the bottom surface308of the activator unit304. In one example, the female stepped-groove310is along a length of the activator unit304. Also, the female stepped-groove310matches with a male stepped-groove (seeFIG. 5) of the attaching unit114. In one embodiment, the female stepped-groove310may be coupled to the male stepped-groove of the attaching unit114to form a track area for the biopsy collecting device300to move laterally or along the axis of the needle unit302on the spectroscopy system100. In one embodiment, the activator unit304may include the male stepped-groove at the bottom surface308of the activator unit304, and the attaching unit114may include the female stepped-groove at the top surface of the attaching unit114. Further, the male stepped-groove of the activator unit304may be coupled to the female stepped-groove of the attaching unit114to form a track area for the biopsy collecting device300to move along the axis of the needle unit302on the spectroscopy system100. It may be noted that the activator unit304may be coupled to the spectroscopy system100by employing other coupling mechanism, and is not limited to the male-female groove coupling as depicted inFIGS. 3 and 4.

In one embodiment, the activator unit304may be magnetically coupled to the spectroscopy system100. Particularly, the bottom surface of the activator unit304and the top surface of the spectroscopy system100may include magnetic material. Further, when the activator unit304is placed on the spectroscopy system100, the bottom surface of the activator unit304may magnetically couple with the top surface of the spectroscopy system100.

Referring toFIG. 5, an attaching unit having a biopsy collecting device, in accordance with aspects of the present disclosure is depicted. Reference numeral502may be representative of the attaching unit114ofFIG. 1. The biopsy collecting300device is used to obtain a biopsy specimen from a patient, and then it is coupled to the attaching unit502. As depicted inFIG. 5, the biopsy collecting device300includes an activator unit304and a needle unit302. The needle unit302is representative of the needle unit200ofFIG. 2.

In a presently contemplated configuration, the attaching unit502is configured to fasten the activator unit304of the biopsy collecting device300to the spectroscopy system100. Particularly, the attaching unit502includes a male stepped-groove504on a top surface506of the attaching unit502. The male stepped-groove504is along a length of the attaching unit502. Also, the male stepped-groove504matches with the female stepped-groove310of the biopsy collecting device300. Particularly, the female stepped-groove310of the biopsy collecting device300may be slidably coupled to the male stepped-groove504of the spectroscopy system100to allow lateral movement of the biopsy collecting device300on the attaching unit502. In one embodiment, the activator unit304slides over the attaching unit502to align the needle unit302at a predetermined position and/or angle on the spectroscopy system100.

In an alternate embodiment, the biopsy collecting device300may be interfaced to the attaching unit502. Particularly, the activator unit304may include a tab that snaps into the attaching unit502directly. It may be noted that the biopsy collecting device300may be coupled to the attaching unit502by using any fastening structure, and is not limited to the structure shown inFIG. 5.

Referring toFIG. 6, a spectroscopy system automatically aligning a biopsy specimen across an illumination light, in accordance with aspects of the present disclosure, is depicted. For ease of understanding of the present disclosure, the spectroscopy system600is described with reference to the components ofFIGS. 1-5. Reference numeral602may be representative of the illumination subsystem102, reference numeral604may be representative of the fixation subsystem104, and reference numeral606may be representative of the detection subsystem106ofFIG. 1. The illumination sub-system602may include a light source108that is configured to emit an illumination light and a guiding unit110to guide the emitted illumination light towards the detection sub-system606, as depicted inFIG. 6. In a similar manner, the detection sub-system606may be used for receiving the illumination light and processing it to determine the diagnostic tissue in the biopsy specimen. As such the sub-system further comprises a detecting unit608and a processing unit610.

In a presently contemplated configuration, the fixation sub-system604includes an attaching unit502that is used to hold a biopsy collecting device300having the biopsy specimen. Furthermore, the attaching unit502that is configured to position the biopsy collecting device300at a predetermined position in the spectroscopy system600. In one example, the attaching unit502may include one or more actuators that may receive control signals from the detection subsystem606and accordingly move the biopsy collecting device300in a forward or backward direction614relative to an illumination path616.

In an exemplary embodiment, the biopsy specimen is automatically aligned to a predetermined position in the spectroscopy system600. Particularly, a portion of a needle unit302of the biopsy collecting device300is first placed between the illumination subsystem602and the detection subsystem606. Further, the illumination light that is passing through or above the needle unit302is processed by the detection subsystem606to determine a current position of the needle unit302. In one example, if the illumination light is hitting a metal portion, such as a stylet206or a cannula204of the needle unit302, the illumination light may not be received by the detection subsystem606. Thus, there will be a substantial amount of signal drop or the signal may not be received by the detection subsystem606. In another example, if the illumination light is passing through air above the needle unit302, the illumination light may not undergo attenuation or transmission losses, and thus, there will be no signal drop at the detection subsystem606. Based on the signal strength and/or the transmission losses in the received signal, the detection subsystem606may determine the current position of the needle unit302.

Upon determining the current position of the needle unit302, the detection subsystem606may send one or more control signals to the attaching unit502to progressively move the needle unit302in a forward or backward direction614until the biopsy specimen is placed at the predetermined position across the illumination path616. In one example, if a tip of the needle unit302, particularly the tip of the stylet206is in the illumination path616, the processing unit610may send one or more controls signals to the attaching unit502to move the biopsy collecting device300in a forward direction relative to the illumination path616. These control signals are provided to the attaching unit502until the biopsy specimen in the collection area of the stylet206is placed across the illumination path616. In one embodiment, the attaching unit114may be at a fixed position, and the spectroscopy system including the illumination subsystem102and the detection subsystem106is adjusted to align the position of the needle unit302across the illumination path616. In another embodiment, the spectroscopy system may be adjusted relative to the movement of the attaching unit114to align the position of the needle unit302across the illumination path616.

After placing or positioning the biopsy specimen across the illumination path616, the illumination light may interact with the biopsy specimen and it may interact with or be attenuated by molecules or chromophores in the biopsy specimen. The resulting re-emitted or attenuated illumination light may be further received by a detecting unit608of the detection subsystem606. In one embodiment, the needle unit302may be moved in a forward or backward direction614so as to pass the illumination light through multiple locations of the tissue sample in the biopsy specimen. This in turn helps in obtaining a detected signal resulting from illumination lights that passed through one or more locations of the tissue sample.

Furthermore, the detecting unit608may receive a light comprising the attenuated illumination light and/or the re-emitted light, and generates an electrical signal corresponding to the received light. Thereafter, the electrical signal corresponding to the received light is sent to the processing unit610. Further, the processing unit610may analyze the generated electrical signal to characterize tissue in the biopsy specimen. More specifically, the electrical signal may be processed by using one or more algorithms to determine one or more parameters of the biopsy specimen. The parameters may include, but not limited to, classification, quantity, quality, adequacy, or other characteristics of diagnostic tissue in the biopsy specimen. The aspect of processing the signal is explained in greater detail with reference toFIG. 7.

Referring toFIG. 7, a detection subsystem processing a received light706to determine the diagnostic tissue, in accordance with aspects of the present disclosure, is depicted. The received light706may comprise an attenuated illumination light and/or a re-emitted light from the biopsy specimen. Reference numeral700may be representative of the detection subsystem106ofFIG. 1. The detection subsystem700includes a detecting unit702, a processing unit704, and a display unit712. The detecting unit702may be similar to the detecting unit116, the processing unit704may be similar to the processing unit118, and the display unit712may be similar to the display unit120ofFIG. 1.

In a presently contemplated configuration, the detecting unit702may be aligned with an illumination subsystem102to receive the illumination light emitted from the illumination subsystem102and the re-emitted light. The illumination light may pass through a biopsy specimen that is positioned between the illumination subsystem102and the detection subsystem106,700. Particularly, the illumination light may pass through at least one location of a tissue sample of the biopsy specimen. Also, the illumination light may be attenuated while passing through the tissue sample. In one example, the illumination light may be attenuated when molecules or chromophores in the tissue may absorb or scatter the illumination light. The chromophores may include for example, oxy hemoglobin, deoxy hemoglobin, water, DNA, NAD(P)H, FAD, Beta carotene, fat, lipids, collagen, elastin, flavins, or combinations thereof.

As greatly appreciated, the illumination light may interact with the tissue sample in the biopsy specimen and may convey information on the state of the diagnostic tissue. Also, these interactions may yield information for diagnosis at the biochemical, structural, or physiological level of the tissue. In addition, endogenous or exogenous chromophores in the tissue sample may be used for interrogation. The endogenous chromophores such as oxy and de-oxy hemoglobin are known to absorb the illumination light706in the wavelength region of about 400 nm to about 700 nm. In this region, tissue scattering is known to dominate over absorption. Additionally, in the UV and near-UV range of the illumination light706, chromophores such as NAD(P)H, flavins, may provide diagnostic information. Each tissue is known to contain certain chromophores predominantly, and hence analyzing them may convey the absorption characteristics of the tissue.

Furthermore, the detecting unit702may include one or more photo detectors710that are used for converting the received light706to a corresponding electrical signal708. The electrical signal708may represent spectrum of the received light706. Since the illumination light is attenuated by the biopsy specimen, the spectrum of the received light706may include one or more spectra associated with chromophores present in the biopsy specimen. In one example, a tissue sample in the biopsy specimen may contain a mixture of certain chromophores and each chromophore may absorb a particular spectral range of the illuminated light. Further, the converted electrical signal708is transmitted to the processing unit704that is communicatively coupled to the detecting unit702.

In the exemplary embodiment, the processing unit704may process the electrical signal708to verify whether the received light706includes a predetermined amount of the attenuated illumination light and/or the re-emitted light. In one example, the processing unit704may compare the electrical signal708associated with the received light706with a threshold value. If the electrical signal708is above the threshold value, the processing unit704confirms that the received light706includes the predetermined amount of the attenuated illumination light and/or the re-emitted light. If the electrical signal708is below the threshold value, the processing unit704may not further process the signal. In one example, the processing unit704may discard the electrical signal708.

Upon confirming that the received light706includes the predetermined amount of the attenuated illumination light and/or the re-emitted light, the processing unit704may determine whether a spectrum of the received signal708is within a predetermined range. Particularly, a memory unit714that is coupled or positioned within the processing unit704may be configured to store data having a plurality of library spectra associated with chromophores includes in one or more pre-identified tissue samples. Further, the processing unit704may compare the spectrum of the received signal708with the plurality of library spectra associated with the chromophores to determine whether the spectrum of the received signal708is within the predetermined range.

Further, if the spectrum of the received signal708is within the predetermined range, the processing unit704may process the received signal708. Particularly, the processing unit704may decompose the received signal708into one or more components or constituents of the tissue in the tissue sample. In one embodiment, a known model, such as a physiological model may be used to decompose the signal708into one or more components. Particularly, the processing unit704may determine a feature for each of the chromophores in the particular location of the tissue sample. Further, the processing unit704may develop the physiological model that aids in decomposing the determined feature into the plurality of components. In another embodiment, the signal708may be decomposed into principal components through various known methods of principal component analysis (PCA).

After decomposing the signal708into one or more components, the processing unit704may evaluate the components of the signal708to classify the tissue at a particular location in the tissue sample. This location in the tissue sample may be a location from which the attenuated and/or reemitted light706is received. In one embodiment, the processing unit704may evaluate the components of the signal708using a machine learned model. Particularly, in the machine learned model, the processing unit704may be first trained with known data-sets, where each of the data-sets represents the type or subtype of the tissues to be classified. In one embodiment, the trained data-sets may be stored in the memory unit714as library of data. In one example, this data may include the spectra associated with the chromophores, principal components of the data, and/or information or signatures associated with one or more types of tissue samples including normal and/or diseased tissues.

Further, the processing unit704may use this trained information to evaluate data associated with the components of the received signal708. More specifically, the processing unit704may evaluate the data to classify the tissue into one or more tissue types. For example, the processing unit704may classify the tissue into tumor or normal tissue type. In another embodiment, the processing unit704may classify the tissue into one or more subtypes of a particular tissue type. For example, the processing unit704may classify the tissue obtained from a kidney region into one of tissue subtypes, such as papillary, chromophobe, or oncocytoma of a cancer tissue type. In another embodiment, the processing unit704may be communicatively coupled to one or more external devices/servers716to communicate the classified data to the external devices/servers716. Further, these external devices/servers716may update the known data sets in the memory unit714of each of the spectroscopy devices through their corresponding processing unit704.

In a similar manner, the processing unit704may receive light706from multiple locations of the tissue sample, and may classify the tissue at a corresponding location into one or more tissue types and/or tissue subtypes. Also, the processing unit704may classify the tissue sample into one or more classes based on the classified tissue types at multiple locations of the tissue sample. For example, if the number of classified tumor tissue type is above a threshold number, then the processing unit704may classify the overall tissue sample as an adequate tumor tissue sample.

Also, the processing unit704may display data associated with the classified tissue types into one or more forms on the display unit712for clinical interpretation. In one example, the processing unit704may convert the data associated with the classified tissue sample into a gray scale or a color scale. Particularly, the processing unit704may convert the data into the gray scale in such a way that an intensity of the gray scale indicates one of the tissue types. Similarly, the processing unit may convert the data into the color scale in such a way that hue saturation of the color scale indicates one of the tissue types.

In the embodiment ofFIG. 8, the biopsy specimen of a kidney tissue sample is processed to classify the tissue at each location of the tissue sample into one of the tissue types. Particularly, the tissue is classified as tumor or other tissue types and the classified tissue types are displayed on the display unit712by different shades of the gray scale, as depicted inFIG. 8. A first shade802in the display unit712is used to represent that the tissue is a tumor tissue type. A second shade804in the display unit714is used to represent that the tissue is a normal tissue type, such as fat, blood etc. A third shade806in the display unit716is used to represent that the tissue is indefinite tissue type. Also, a fourth shade808in the display unit716is used to represent that the tissue is an outlier of the tissue sample. In addition,FIG. 8depicts graphs for each tissue type that indicates the transmittance spectra of a corresponding tissue type. In another embodiment, the above mentioned classified tissue types may be represented by different colors of the color scale on the display unit712.

In one embodiment, the processing unit704may indicate the presence or absence of the tumor tissue types with two colors or shades. For example, if the data associated with the tissue is above a threshold value, then the processing unit704may indicate the corresponding tissue as a tumor tissue and may display this tissue with a first color or shade on the display unit712. Otherwise, the processing unit704may indicate the tissue as a normal tissue and may display this tissue with a second color or shade on the display unit712.

In another embodiment, the processing unit704may derive a numerical value for the data associated with the classified tissue. Further, the processing unit704may display the numerical value adjacent to the assigned color or shades of the classified tissue on the display unit712.

In yet another embodiment, the processing unit704may provide an aggregate recommendation at the biopsy level. Particularly, the processing unit704may assign a point for each classified tumor tissue in the tissue sample. If the number of points in the tissue sample is above a threshold number, the processing unit704may indicate that the tissue sample is a positive tissue sample on the display unit704. Otherwise, the processing unit704may indicate that the tissue sample is a negative tissue sample on the display unit704. In this manner, a recommendation of “adequacy” is rendered for each biopsy, given that a minimum amount of tissue is required for adequate downstream molecular testing. This recommendation may be provided with or without immediately revealing the classifier outputs at each location along the tissue sample.

In one another embodiment, the processing unit704may provide a statistical confidence of tissue adequacy for the biopsy. This may be derived from larger sample statistics, such as receiver-operator characteristic curves902, obtained from relevant academic studies or clinical trials, as depicted inFIG. 9. Particularly, Receiver-operator characteristic (ROC) curve obtained on classification of more than 550 kidney samples are depicted in the display unit712. Each curve902represents the statistical probability used as a cutoff by the classifier. However, in the embodiment ofFIG. 9, the ROC curves902are performed at the biopsy level, rather than at the individual spectral level.

Furthermore, in one embodiment, the processing unit704may also display data associated with the amount of the attenuated illumination light and/or the re-emitted light received from the biopsy specimen. This data may be displayed in one or more forms on the display unit712. In one example, the processing unit704may display this data similar to the data shown inFIG. 8. Particularly, if the data is above the threshold value, the processing unit704may assign a first shade or color to the data associated with the received light706. Otherwise, the processing unit704may assign a second shade or color to the data. This information on the display unit712would be useful for the user or operator to visually analyze the received light.

In a similar manner, the processing unit704may also display the spectrum of the received signal708on the display unit712. In one embodiment, the processing unit704may compare the spectrum of the received signal708with the plurality of library spectra associated with the chromophores to determine whether the spectrum of the received signal708is within the predetermined range. Also, the data associated with the spectrum of the received signal708is displayed in one or more forms on the display unit712. For example, if the spectrum of the received signal708is within the predetermined range, the processing unit704may assign a first shade or color to the data. Otherwise, the processing unit704may assign a second shade or color to the data. It may be noted that the processing unit704may display the data associated with the spectrum of the received signal708in one or more forms, and is not limited to the color or shade display form as described above.

Referring toFIG. 10, a flow chart illustrating a method1000for classifying a tissue sample of a biopsy specimen, in accordance with aspects of the present disclosure, is depicted. For ease of understanding, the method is described with reference toFIGS. 1-7. The method begins at step1002, where an illumination light that is passed through at least one location of the tissue sample of the biopsy specimen is received by a detection subsystem700. To that end, a detecting unit702in the detection subsystem700is used to receive the light706that has interacted with the tissue sample. Particularly, the detecting unit702may include one or more photo detectors710that are used for converting the received light706to a corresponding electrical signal708. Further, the electrical signal708may include a spectrum of the received light. Thereafter, the converted electrical signal708is transmitted to the processing unit704that is communicatively coupled to the detecting unit702.

Subsequently, at step1004, the received signal708may be verified to determine whether the signal708may include a predetermined amount of at least one of an attenuated illumination light and a re-emitted light. To that end, the processing unit704may compare the received light706with a threshold value to determine whether the received signal708includes the predetermined amount of the attenuated illumination light and/or the re-emitted light.

Furthermore, at step1006, the spectrum of the received signal708is processed by the processing unit704to determine that the spectrum of the received signal708is within a predetermined range. Particularly, the memory unit714may store data having a plurality of library spectra associated with chromophores included in one or more pre-identified tissue samples. Further, the processing unit704may compare the spectrum of the received signal708with this plurality of library spectra associated with the chromophores to determine whether the spectrum of the received signal708is within the predetermined range.

In addition, at step1008, the spectrum of the received signal is processed by the processing unit704to decompose the signal into a plurality of components. In one embodiment, the processing unit704may determine a feature for each of the chromophores in the particular location of the tissue sample. Further, the processing unit704may develop a physiological model to decompose the determined feature into one or more components.

Further, at step1010, the tissue at the particular location of the tissue sample is classified into one of a plurality of tissue types based on the plurality of components. In one embodiment, the processing unit704may evaluate the components of the signal708using a machine learned model. Particularly, in the machine learned model, the processing unit704may be first trained with known data-sets, where each of the data-sets represents the type or subtype of the tissues to be classified. Further, the processing unit704may use this trained information to evaluate data associated with the components of the received signal708. More specifically, the processing unit704may evaluate the data to classify the tissue into one or more tissue types. For example, the processing unit704may classify the tissue into tumor or normal tissue type.

Also, at step1012, the processing unit704may display data associated with the classified tissue for clinical interpretation. To that end, the processing unit704may display the data in one or more forms on the display unit712. This displayed data may aid in evaluation of biopsy adequacy and also for determining different tissue types in the biopsy.

Referring toFIG. 11, a flow chart illustrating a method1100for coupling a biopsy collecting device to a spectroscopy system, in accordance with aspects of the present disclosure, is depicted. For ease of understanding of the present disclosure, the method is described with reference to the components ofFIGS. 1-7. The method begins at step1102, where a biopsy specimen is collected from a patient. Particularly, a needle unit200of the biopsy collecting device300may be pierced into the patient to collect the biopsy specimen from a desired tissue site in the patient.

Subsequently, at step1104, the biopsy collecting device300is detachably coupled to the spectroscopy system100. Particularly, the activator unit304includes a channel306at a bottom surface308of the activator unit304. This channel306may be formed with a female stepped-groove310along the length of the activator unit304. Further, the biopsy collecting device300is positioned on the attaching unit502in such a way that the female stepped-groove310mates or couples with the male stepped-groove504of the attaching unit502. Also, the female stepped-groove310may be coupled to the male stepped-groove of the attaching unit502to form a track area for the biopsy collecting device300to move laterally on the spectroscopy system100.

The various embodiments of the system and method aid in diagnosing tissue in a biopsy specimen. Also, the amount of diagnostic tissue in an excised biopsy specimen is determined without removing the biopsy specimen from a biopsy needle or a biopsy collecting device. This in turn may reduce the time and cost for examining biopsy of a patient. In addition, exposing the biopsy specimen to air may quickly degrade the tissue sample. Therefore, a fast scan of the biopsy specimen directly in the biopsy needle allows for rapid characterization with minimal impact on the biopsy specimen. Also, characterization in the biopsy needle minimizes the impact on existing clinical workflow. Moreover, the diagnostic tissue in the biopsy specimen may be classified into a normal tissue or an abnormal tissue, which in turn aids in determining the quality, the quantity, and other characteristics of the diagnostic tissue in the biopsy specimen.