Single-insertion, multiple sampling biopsy device usable with various transport systems and integrated markers

• US 8,961,430 B2
• Filed: 09/10/2012
• Issued: 02/24/2015
• Est. Priority Date: 08/10/2005
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Coonahan, Timothy J., Thompson, Stanley O., Taylor, Jon
• Primary Examiner(s): Szmal, Brian
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US13/608,609
• Publication Number:
  US 20120330185A1
• Time in Patent Office: 897 Days
• Field of Search: 600/562, 600564-568, 606/167, 606170-171, 604/164.01, 60416411-16412
• US Class Current: 600/565
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2090/3904 specially adapted for marking specified tissue
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 2090/3991 having specific anchoring means to fixate the marker to the tissue, e.g. hooks

Abstract

A biopsy device includes a biopsy sample extraction needle with a sample extraction end and a recovery end. A transport channel links the extraction end and recovery end. A pump is provided, and a multi-way valve is coupled in fluid communication with the biopsy sample extraction needle and the pump. The multi-way valve has a plurality of settings.

Claims

1. A biopsy device, comprising:

a biopsy sample extraction needle with a sample extraction end, recovery end, and a transport channel linking the extraction and recovery ends;

a pump;

a unitary multi-way valve consisting of one of a three-way valve and a four-way valve, the unitary multi-way valve coupled in fluid communication with the biopsy sample extraction needle and the pump, the unitary multi-way valve having a plurality of settings; and

a fluid reservoir configured to carry a fluid, the fluid reservoir coupled in fluid communication with the transport channel of the biopsy sample extraction needle and the pump,

the pump and the unitary multi-way valve being configured such that;

a vacuum is drawn at at least the sample extraction end of the biopsy sample extraction needle with the unitary multi-way valve in a first setting of the plurality of settings;

fluid is drawn from the reservoir with the unitary multi-way valve in a second setting of the plurality of settings, and

the transport channel of the biopsy sample extraction needle is flushed with the fluid from the extraction end of the biopsy sample extraction needle to the recovery end of the biopsy sample extraction needle to transport a sample through the transport channel with the unitary multi-way valve in a third setting of the plurality of settings,

wherein the fluid is saline, and the device is configured to recover residual saline from the transport channel of the biopsy sample extraction needle and deliver the recovered residual saline back to the reservoir.

2. A biopsy device comprising:

a stylet having a distal end and a proximal end, the stylet having a sample opening near the distal end and a recovery position near the proximal end;

the stylet having an interior volume adjacent the stylet distal end, the sample opening providing access to the interior volume, the stylet including a fluid lumen adjacent the interior volume;

a cassette with multiple recesses each having an access and a fluid-permeable blind end, the cassette positioned at the recovery position to align a selected one of the cassette recesses with the recovery position such that the selected cassette recess is in fluid communication with the interior volume of the stylet; and

a transport mechanism configured to force a fluid from the stylet distal end toward the stylet proximal end such that fluid exits the blind end of the selected cassette recess, whereby a specimen is flushed into the selected cassette recess,

wherein the transport mechanism includes a reservoir, a pump, and a multi-way valve;

the multi-way valve being connected in fluid communication with the fluid lumen, the reservoir, and the pump;

the transport mechanism being configured to operate the pump and the multi-way valve to transport fluid from the reservoir to the stylet distal end during a transport cycle and configured to recover fluid remaining in the fluid lumen by returning the fluid to the reservoir during a reset cycle.

3. The device of claim 2, wherein the cassette recesses are linked together by flexible connections to form a bandolier.

4. The device of claim 2, further comprising a vacuum source, the transport mechanism including a vacuum connection from the vacuum source to the selected recess blind end to aid in drawing a specimen into the selected recess.

5. The device of claim 2, wherein the further comprising a vacuum source, the transport mechanism including a vacuum connection from the vacuum source to the selected recess blind end, the vacuum source and the transport mechanism being housed in a self- contained handheld unit with a volume of less than 500 cubic centimeters.

6. The device of claim 2, wherein the stylet has two parallel lumens, a primary lumen for transporting specimens and a secondary lumen for conveying fluid from a proximal end of the stylet to the distal end of the stylet where the fluid returns to the proximal end through the primary lumen.

7. The device of claim 6, wherein the stylet has a sample opening for receiving specimens from a host at the distal end and the stylet carries a cutting cannula that surrounds the stylet and selectively covers the sample opening, the transport mechanism configured to convey fluid to transport specimens only when the cutting cannula covers the sample opening.

9. The device of claim 2, wherein the multi-way valve is a four-way valve.

8. A biopsy device, comprising:

a biopsy sample extraction needle with a sample extraction end, recovery end, and a transport channel linking the extraction and recovery ends;

a pump;

a unitary multi-way valve consisting of one of a three-way valve and a four-way valve, the unitary multi-way valve coupled in fluid communication with the biopsy sample extraction needle and the pump, the unitary multi-way valve having a plurality of settings; and

a fluid reservoir configured to carry a fluid, the fluid reservoir coupled in fluid communication with the transport channel of the biopsy sample extraction needle and the pump,

the pump and the unitary multi-way valve being configured such that;

a vacuum is drawn at at least the sample extraction end of the biopsy sample extraction needle with the unitary multi-way valve in a first setting of the plurality of settings;

fluid is drawn from the reservoir with the unitary multi-way valve in a second setting of the plurality of settings, and

the transport channel of the biopsy sample extraction needle is flushed with the fluid from the extraction end of the biopsy sample extraction needle to the recovery end of the biopsy sample extraction needle to transport a sample through the transport channel with the unitary multi-way valve in a third setting of the plurality of settings,

the device configured to recover residual fluid from the transport channel of the biopsy sample extraction needle and deliver the recovered residual fluid back to the reservoir.