CN-121986253-A - Device and method for separating tissue samples for multiple diagnostic modalities and packaging therefor

Abstract

Disclosed herein are devices and methods for recovering solid tissue and shed cells ("D-cells") from a biopsy. In an embodiment, a biopsy container device includes a sample collection container, a basket screen, and a buffer container. The sample collection container includes a reagent chamber. The basket screen is configured for at least partially removable attachment within the sample collection container, and includes a screen surface configured to allow the passage of shed cells from the biopsy but not solid tissue from the biopsy. The buffer container is configured for removable attachment to the sample collection container, and the buffer container includes a buffer chamber.

Inventors

• Alexander. Arrow
• Wilfredo Mojika

Assignees

• 维尔肖医疗公司

Dates

Publication Date

20260505

Application Date

20240913

Priority Date

20240103

Claims (20)

1. 1. A biopsy container device for recovering solid tissue and exfoliated cells ("D-cells") from a biopsy, the biopsy container device comprising: a sample collection container comprising a reagent chamber; A basket screen configured for at least partially removable attachment within the sample collection container, the basket screen comprising a screen surface configured to allow passage of the D-cells from the biopsy but not the solid tissue from the biopsy, and A buffer container configured for removable attachment to the sample collection container, the buffer container comprising a buffer chamber.
2. 2. The biopsy container device of claim 1, wherein The buffer container includes a funnel portion configured to direct the solid tissue and the D-cells from the biopsy into the buffer chamber.
3. 3. The biopsy container device of claim 2, wherein The buffer container is configured for attachment to the sample collection container, and the buffer chamber is at least partially within the sample collection container, and the funnel is at least partially external to the sample collection container.
4. 4. The biopsy container device of claim 1, wherein The sample collection container includes a boss or ridge configured to suspend the basket screen within the sample collection container above the reagent chamber.
5. 5. The biopsy container device of claim 1, wherein The buffer container includes a first attachment mechanism, The sample collection container includes a second attachment mechanism, and The buffer container is removably attached to the sample collection container by engagement between the first and second attachment mechanisms.
6. 6. The biopsy container device of claim 5, wherein The first and second attachment mechanisms include corresponding threads that enable the buffer container to be threadably connected to the sample collection container.
7. 7. The biopsy container device of claim 5, wherein The first and second attachment mechanisms include rubber sleeves that enable the buffer container to be removably attached to the sample collection container.
8. 8. The biopsy container device according to claim 1, comprising A cap that fits both the sample collection container and the buffer container.
9. 9. The biopsy container device of claim 1, wherein The sample collection container is prefilled with a reagent in the reagent chamber, and The buffer container is prefilled with a buffer solution in the buffer chamber.
10. 10. The biopsy container device of claim 9, wherein The sample collection container includes between 1mL and 2mL of reagent, and The buffer container includes between 1mL and 2mL of buffer solution.
11. 11. The biopsy container device of claim 9, wherein The sample collection container includes a first amount of reagent, an The buffer container includes a second amount of buffer solution having a volume approximately equal to the volume of the first amount of reagent.
12. 12. The biopsy container device of claim 1, wherein The buffer container includes a skirt configured to removably attach the sample collection container.
13. 13. The biopsy container device of claim 9, wherein The buffer solution is a sterile phosphate buffer salt solution.
14. 14. A biopsy container device for recovering solid tissue and exfoliated cells ("D-cells") from a biopsy, the biopsy container device comprising: an upper chamber; A lower chamber; A screen surface between the upper chamber and the lower chamber, the screen surface configured to allow the D-cells from the biopsy to pass but not the solid tissue from the biopsy, and A solid surface movably attached relative to the screen surface, the solid surface configured to translate between (i) a first configuration in which the solid surface overlaps the screen surface to prevent the D-cells from passing through the screen surface, and (ii) a second configuration in which the solid surface is moved away from the screen surface to allow the D-cells to pass through the screen surface from the upper chamber to the lower chamber.
15. 15. A method of recovering solid tissue and shed cells ("D-cells") from a biopsy using a buffer container apparatus comprising a buffer container, a basket screen, and a sample collection container, the method comprising: releasing the solid tissue and the D-cells from the biopsy into a buffer solution within the buffer container; Removing the buffer container from the basket screen and the sample collection container; pouring the solid tissue, the D-cells, and the buffer solution into the basket screen while the basket screen is within the sample collection container; Removing the basket sieve with the solid tissue from the sample collection container; placing the basket sifter with the solid tissue in a sealed container for tissue treatment, and The seal includes the D-cells, the buffer solution, and the reagent mixture for use in a diagnostic test.
16. 16. The method of claim 15, comprising Releasing the solid tissue and the D-cells from the hollow needle into the buffer chamber.
17. 17. The method of claim 15, wherein Sealing a mixture comprising the D-cells, the buffer solution, and the reagent comprises sealing the mixture within the sample collection container.
18. 18. The method of claim 15, comprising The buffer container device is received, wherein the buffer container, the basket screen, and the sample collection container are attached together.
19. 19. The method of claim 18, comprising The buffer container device is received, wherein the sample collection container is prefilled with a reagent, the basket screen is at least partially within the sample collection container, and the buffer container is prefilled with a buffer solution and is at least partially within the sample collection container.
20. 20. The method of claim 15, comprising Removing a cover from the buffer container prior to releasing the solid tissue and the D-cells from the biopsy into the buffer container, and Wherein sealing a mixture comprising the D-cells, the buffer solution, and the reagent for diagnostic testing comprises sealing the D-cells, the buffer solution, and the reagent within the sample collection container using the cap.

Description

Device and method for separating tissue samples for multiple diagnostic modalities and packaging therefor Priority The present application claims priority from U.S. application Ser. No. 18/468,416, entitled "method and System for recovering an assessable analyte from a hollow core needle biopsy," U.S. application Ser. No. 18/514,870, entitled "apparatus and method for separating tissue samples for multiple diagnostic modalities," filed on Ser. No. 2023, ser. No. 9, ser. No. 15, and U.S. application Ser. No. 18/403,550, entitled "apparatus and method for separating tissue samples for multiple diagnostic modalities," filed on Ser. No. 2024, ser. No. 11, and entitled "medical instrument packaging Container," filed on Ser. No. 2024, ser. No. 11, and incorporated herein by reference in its entirety for all purposes. Technical Field The present disclosure relates generally to devices and methods for separating tissue samples for multiple diagnostic modalities. More particularly, the present disclosure relates to biopsy container devices for recovering solid tissue and exfoliated cells from a biopsy, and corresponding methods of use and packaging thereof. The present disclosure relates generally to packaging for such containers. Background Biopsies have been used for medical diagnosis for many years as a method of extracting and analyzing cell or tissue samples to better understand the nature and extent of the disease. Biopsies can aid in diagnosis of a variety of conditions such as cancer, where microscopic fragments of suspected hyperplasia or lesions are removed for microscopic examination. Through this examination, the pathologist may attempt to detect abnormalities, the presence of malignant cells, infections, or other pathological conditions. The procedure in which the biopsy is taken may vary based on the location and nature of the tissue or cell being sampled. Some biopsies, such as those for skin, are simple and may use only needles or scalpels, and potentially local anesthesia. However, deep tissues such as those within organs or bones may require more invasive techniques, including the use of imaging guides such as ultrasound, CT, or MRI. Biopsies play a role in the medical decision-making process. While imaging and clinical assessment may provide insight into the condition of a patient, diagnosis may rely on cellular and molecular details that can be provided by biopsy alone. It can aid in determining the presence of a disease and can provide information about its stage, potential aggressiveness, and other features critical to customizing an effective treatment strategy. Solid tumor diagnostic procedures typically involve tissue biopsies. Traditionally, biopsies involve surgical removal of a large amount of tissue from a patient's tumor or suspected affected tissue. Once removed from the patient, the tissue is treated and subsequently available for a variety of different types of diagnostic tests. In recent years, biopsy tools and techniques have evolved to be less invasive and significantly smaller in tissue samples. Surgical resection biopsy has been largely replaced by hollow needle biopsy (CNB) tools. Smaller biopsies are less invasive to the patient, faster for the clinician to perform, and generally cheaper for the healthcare system. Thus, standard biopsy tissue sizes have been significantly reduced between the period before about 2010 and the years after. A disadvantage of smaller biopsies is that they provide less tissue for a pathologist to examine and analyze to give diagnostic insight. Meanwhile, diagnostic test patterns have been expanded to include a greater number of tests aimed at identifying molecular changes. The reduced size of biopsy tissue and the increased number of tests required on biopsy tissue have created an imbalance between tissue supply and demand. As a result, in some cases, clinicians make treatment decisions for patients with less than their desired diagnostic information. In other cases, the patient receives a second biopsy. The risk that a biopsy sample will have insufficient tissue to allow a clinically indicated test is a big enough problem that it has several unofficial names, "tissue depletion" is most common. The tissue exhaustion rates reported in the literature for hollow core needle biopsies are between 22% and 82% of all biopsies. Thus, there is an imbalance between the typical tissue volume produced by hollow core needle biopsies and the typical tissue volume required for testing. The quality and quantity of sample material available for molecular testing is deficient in affecting healthcare quality. This ultimately affects patient care, and many specimens received in pathology labs are not available for molecular testing, resulting in these patients missing improved treatment options associated with accurate medicine (accurate medicine is defined as using molecular testing to find mutations to guide treatment). Unfortunately, current standard tissue biopsy t