CORE BIOPSY SYSTEM FOR STORAGE AND PRESERVATION OF MULTIPLE TISSUE SAMPLES

• US 20190321009A1
• Filed: 01/08/2018
• Published: 10/24/2019
• Est. Priority Date: 01/06/2017
• Status: Active Grant

• Current Assignee: Sorek Medical Systems, Ltd.
• Original Assignee: Sorek Medical Systems, Ltd.
• Inventors: NEVO, EREZ, BERGER, ZVI
• Granted Patent: US 11,589,845 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 10/0096 Casings for storing test samples A61B10/0038 and A61B10/0045 take precedence; preservation of living parts of the human or animal body A01N1/02; containers for retaining a material to be analysed B01L3/50; containers for enzymology or microbiology C12M1/16; swab-sampler being part of enzymology or microbiology container C12M1/30
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 2010/0225 for taking multiple samples

Abstract

A core biopsy system includes a core biopsy needle device and biopsy sample collection device, wherein the core biopsy needle device is positionable within and movable with respect to the biopsy sample collection device. Systems and methods for obtaining multiple biopsy samples with a single insertion of a needle of the biopsy needle device include obtaining sequential samples and storage in a multi-cell cartridge. Additional features and methods of the invention include obtaining two sample portions from each sample acquisition, wherein each of the two sample portions can be separately preserved and analyzed.

Claims

1. A core biopsy system comprising:

a core biopsy needle device, the core biopsy needle device comprising;

a stylet comprised of an elongate member having a stylet proximal end, a stylet distal end, at least one sample receiving portion at said stylet distal end, and a stylet controller at said stylet proximal end;

a cutting cannula comprised of an outer elongate member coaxially arranged around said stylet, said outer elongate member having a cannula proximal end, a cannula distal end, a sample cutting portion at said cannula distal end, and a slider at said cannula proximal end, wherein said cutting cannula is slidingly movable with respect to said stylet, wherein said stylet is configured to be pulled proximally with respect to said cutting cannula using said stylet controller; and

a firing mechanism connected to said slider; and

a biopsy sample collection device, the biopsy sample collection device comprising;

a stylet housing for positioning of said stylet therein, wherein said stylet is slidingly positionable within said stylet housing; and

a sample storage compartment adjacent to said stylet housing, said sample storage compartment configured to obtain single or multiple samples from said sample receiving portion of said stylet and to store the single obtained sample or multiple obtained samples.

2. The core biopsy system of claim 1, wherein the stylet housing further comprises a stylet track for slidingly positioning of the stylet.

3. The core biopsy system of claim 1, wherein the biopsy sample collection device further comprises a sample unloading dock for transfer of a first tissue sample from the stylet into a first storage cell of the sample storage compartment and for subsequent transfer of a second tissue sample into a second storage cell of the sample storage compartment.

4. The core biopsy system of claim 1, wherein the sample storage compartment is a cartridge having multiple storage cells.

5. The core biopsy system of claim 1, wherein the at least one sample receiving portion of the stylet is a first notch for holding a first sample therein.

6. The core biopsy system of claim 5, wherein the at least one sample receiving portion of the stylet further comprises a second notch opposite the first notch for holding a second sample therein.

7. The core biopsy system of claim 1, further comprising an unloading mechanism including a slot in said stylet housing and a sample extractor positionable through said slot, wherein said sample extractor is configured to extract a tissue sample from the stylet and position it in the sample storage compartment.

8. The core biopsy system of claim 7, wherein the slot comprises a first slot and a second slot, and wherein the pushing component comprise a first pushing plate and a second pushing plate wherein said first pushing plate is configured to enter the first slot and push a first sample portion into a first cell of the sample storage compartment, and the second pushing plate is configured to enter the second slot and push a second sample portion into a second cell of the sample storage compartment.

9. A biopsy sample collection device, the biopsy sample collection device comprising:

a housing having a stylet track for slidingly positioning of a stylet therein, the stylet configured to temporarily hold a first tissue sample therein and to subsequently unload the temporarily held first tissue sample and to temporarily hold a second tissue sample and to subsequently unload the temporarily held second tissue sample;

a storage cartridge adjacent to said housing, said storage cartridge having a first storage cell for storage of the temporarily held first tissue sample and a second storage cell for storage of the temporarily held second tissue sample; and

a sample unloading dock for transfer of the temporarily held first tissue sample from the stylet into the first storage cell of the storage cartridge and for subsequent transfer of the temporarily held second tissue sample into the second storage cell of the storage cartridge.

10. The biopsy sample collection device of claim 9, wherein the stylet is configured to hold the first and second tissue samples simultaneously.

11. The biopsy sample collection device of claim 9, further comprising an unloading mechanism including a slot in said stylet housing and a sample extractor positionable through said slot, said sample extractor configured to extract the first tissue sample and subsequently the second tissue sample from the stylet and position it in the sample storage compartment.

12. The core biopsy system of claim 11, wherein the slot comprises a first slot and a second slot, and wherein the pushing component comprise a first pushing plate and a second pushing plate wherein said first pushing plate is configured to enter the first slot and push the first sample portion into a first cell of the sample storage compartment, and the second pushing plate is configured to enter the second slot and push the second sample portion into a second cell of the sample storage compartment.

13. The core biopsy system of claim 11, wherein said sample extractor is configured to extract a first tissue sample having a first tissue sample first portion and a first tissue sample second portion wherein said extraction is of said first tissue sample first portion and said first tissue sample second portion is done simultaneously, and to subsequently extract a second tissue sample having a second tissue sample first portion and a second tissue sample second portion, wherein said extraction is of said second tissue sample first portion and said second tissue sample second portion is done simultaneously.

14. The core biopsy system of claim 12, wherein said first pushing plate is longer than said second pushing plate.

15. A method of biopsy sample collection and storage, the method comprising:

inserting a core biopsy needle having a stylet positioned within a cutting cannula into a tissue;

cutting a first tissue sample using the cutting cannula;

positioning the cut first tissue sample within the stylet;

retracting the stylet from the tissue while maintaining the cutting cannula positioned in the tissue;

unloading the cut first tissue sample from the stylet into a storage cartridge;

reinserting the stylet through the cutting cannula into the tissue;

cutting a second tissue sample using the cutting cannula;

positioning the cut second tissue sample within the stylet;

retracting the stylet from the tissue; and

unloading the cut second tissue sample from the stylet into the storage cartridge.

16. The method of claim 15, wherein said cutting a first tissue sample comprises cutting a first tissue sample first portion and a first tissue sample second portion simultaneously, and wherein said positioning the cut first tissue sample within the stylet comprises positioning the first tissue sample first portion and the first tissue sample second portion simultaneously, and wherein said unloading the cut first tissue sample into the storage cartridge comprises unloading the first tissue sample first portion and the first tissue sample second portion simultaneously.

17. The method of claim 15, wherein said cutting a second tissue sample comprises cutting a second tissue sample first portion and a second tissue sample second portion simultaneously, and wherein said positioning the cut second tissue sample within the stylet comprises positioning the second tissue sample first portion and the second tissue sample second portion simultaneously, and wherein said unloading the cut second tissue sample into the storage cartridge comprises unloading the second tissue sample first portion and the second tissue sample second portion simultaneously.

18. The method of claim 16, wherein the storage compartment is separatable into a first storage compartment portion holding the first tissue sample first portion and a second storage compartment portion holding the first tissue sample second portion, and further comprising separating the first storage compartment portion from the second storage compartment portion after said unloading of the first tissue sample first portion and the first tissue sample into the storage compartment.

19. The method of claim 18, further comprising separately preserving the first tissue sample first portion and the first tissue sample second portion by applying different preservation methods to each of said first and second storage compartment portions.

20. The method of claim 19, wherein the applying of different preservation methods is done prior to the separating of the first and second storage compartment portions.