Disposable biopsy unit

• US 9,072,502 B2
• Filed: 12/29/2011
• Issued: 07/07/2015
• Est. Priority Date: 03/19/2002
• Status: Expired due to Fees

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Heske, Norbert, Heske, Thomas
• Primary Examiner(s): Cohen, Lee S
• Assistant Examiner(s): LLOYD, EMILY M
• Application Number:
  US13/340,115
• Publication Number:
  US 20120095366A1
• Time in Patent Office: 1,286 Days
• Field of Search: 600/562, 600564-568, 606/167, 606/170
• US Class Current: 1/1
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• 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 17/3421 Cannulas
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00911 for fields applied by a magnetic resonance imaging system
• CPC Class Codes: A61B 2017/00924 for ultrasonic waves
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 90/03 Automatic limiting or abutting means, e.g. for safety
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61M 39/1055 Rotating or swivel joints in general F16L27/00
• CPC Class Codes: A61M 39/12 for joining a flexible tube to a rigid attachment
• CPC Class Codes: G01N 1/08 involving an extracting tool, e.g. core bit

Abstract

A disposable biopsy unit includes a biopsy needle unit and a pump. The biopsy needle unit includes a carrier, a biopsy needle and a cutting sheath. The carrier is configured to mount the biopsy needle and the cutting sheath. The cutting sheath is configured to move along a longitudinal axis relative to the biopsy needle. The pump has an elongate cylinder and a plunger. The plunger is configured to be movable inside the elongate cylinder in a first direction from a distal end of the elongate cylinder to a proximal end of the elongate cylinder to generate a vacuum and configured to be movable inside the elongate cylinder in a second direction from the proximal end of the elongate cylinder to the distal end of the elongate cylinder to build up pressure. The distal end of the elongate cylinder is coupled in fluid communication with the biopsy needle.

Claims

1. A disposable biopsy unit for removable coupling to a handheld biopsy driver, comprising:

a biopsy needle unit including a carrier, a biopsy needle and a cutting sheath, the carrier being configured to mount the biopsy needle and the cutting sheath, the biopsy needle having a sample removal chamber and a longitudinal axis, the cutting sheath being coaxially arranged with the biopsy needle, the cutting sheath being configured to move along the longitudinal axis relative to the biopsy needle;

a pump having an elongate cylinder and a plunger, the plunger configured to be movable inside the elongate cylinder in a first direction from a proximal end of the elongate cylinder to a distal end of the elongate cylinder to generate a vacuum and configured to be movable inside the elongate cylinder in a second direction from the distal end of the elongate cylinder to the proximal end of the elongate cylinder to build up pressure;

a connection element, the proximal end of the elongate cylinder being coupled in fluid communication with the biopsy needle via the connection element, the connection element configured to facilitate an arrangement of the disposable biopsy unit wherein the elongate cylinder is positioned such that the elongate cylinder and the biopsy needle are in a parallel arrangement; and

a holder piece configured to hold the elongate cylinder and the biopsy needle in the parallel arrangement.

2. The disposable biopsy unit of claim 1, wherein the biopsy needle is rotatably mounted to the carrier.

3. The disposable biopsy unit of claim 1, comprising:

a plastic part mounted to a proximal end of the biopsy needle, wherein the plastic part comprises a first portion formed as a knurled disk and a second portion formed as a polygon, wherein the polygon is turned by a rotation of the knurled disk, and

wherein the polygon of the plastic part is configured to interact with the carrier during rotation of the polygon relative to the carrier to lock the biopsy needle in a selected rotational position.

4. The disposable biopsy unit of claim 1, wherein the cutting sheath is rotatably mounted to the carrier to facilitate both longitudinal movement and rotational movement of the cutting sheath relative to the carrier and the biopsy needle.

5. The disposable biopsy unit of claim 1, wherein the carrier has a nut with internal threads, and the cutting sheath has a threaded spindle meshed with the internal threads of the nut, the cutting sheath having a gear coupled to the threaded spindle to drive the threaded spindle when the gear is rotated.

6. The disposable biopsy unit of claim 1, wherein the biopsy needle includes:

a lumen in fluid communication with the sample removal chamber and the pump, and

a narrowing positioned in the lumen at a proximal end of the sample removal chamber, the narrowing being positioned at a top portion of the lumen, leaving a passage at a bottom portion of the lumen.

7. The disposable biopsy unit of claim 6, wherein the narrowing comprises 60-75% of the cross section of the lumen.

8. The disposable biopsy unit of claim 6, wherein the narrowing comprises a stopper having a length of approximately 10 mm.

9. The disposable biopsy unit of claim 6, wherein the narrowing is formed as a lip or dog protruding into the cross section of the lumen.

10. The disposable biopsy unit of claim 1, wherein an opening of the sample removal chamber comprises approximately 25% of the cross section of the biopsy needle.

11. The disposable biopsy unit of claim 1, wherein the connection element is a flexible tube formed in an arc of around 180 degrees, the flexible tube is configured to communicate a vacuum or pressure from the elongate cylinder to the biopsy needle.

12. The disposable biopsy unit of claim 1, wherein the elongate cylinder has a ventilation opening near the distal end, the ventilation opening being configured to dissipate the vacuum generated by a retraction of the plunger in the first direction.

13. The disposable biopsy unit of claim 1, wherein the plunger includes a rack, and further comprising a toothed crown nut rotatably engaged with the distal end of the elongate cylinder, the toothed crown nut being configured to mesh with the rack, the toothed crown nut having a toothed crown gear configured to be rotatably driven.

14. A disposable biopsy unit for removable coupling to a handheld biopsy driver, comprising:

a carrier;

a biopsy needle assembly mounted to the carrier; and

a pump including;

an elongate cylinder, the elongate cylinder being connected in fluid communication with the biopsy needle assembly;

a plunger configured to translate inside the elongate cylinder, the plunger having a rack; and

a toothed crown nut configured to mesh with the rack, and the toothed crown nut being configured to rotatably engage an end portion of the elongate cylinder when the toothed crown nut is rotated in a first direction, and the toothed crowned nut is further configured to translate the plunger in a first longitudinal direction in the elongate cylinder to generate vacuum when the toothed crown nut is rotated in the first direction, and wherein the toothed crowned nut is configured for rotation in a second direction opposite the first direction to facilitate generation of pressure in the elongate cylinder via a translation of the plunger in a second longitudinal direction opposite the first longitudinal direction.

15. The disposable biopsy unit of claim 14, wherein the elongate cylinder is connected to the biopsy needle assembly by a flexible tube that is formed in an arc of around 180 degrees such that the elongate cylinder and the biopsy needle assembly are in a parallel arrangement, and further comprising a holder piece configured to hold the elongate cylinder and the biopsy needle assembly in the parallel arrangement.

16. The disposable biopsy unit of claim 14, wherein the biopsy needle assembly includes a biopsy needle and a cutting sheath, the biopsy needle having a lumen and a sample removal chamber, and the cutting sheath being coaxially arranged with the biopsy needle.

17. The disposable biopsy unit of claim 16, wherein the biopsy needle is rotatably mounted to the carrier, and comprising:

a plastic part mounted to a proximal end of the biopsy needle, wherein the plastic part comprises a first portion formed as a knurled disk and a second portion formed as a polygon, wherein the polygon is turned by a rotation of the knurled disk, and

wherein the polygon of the plastic part is configured to interact with the carrier during rotation of the polygon relative to the carrier to lock the biopsy needle in a selected rotational position.

18. The disposable biopsy unit of claim 16, wherein the cutting sheath is rotatably mounted to the carrier to facilitate both longitudinal movement and rotational movement of the cutting sheath relative to the carrier and the biopsy needle.

19. The disposable biopsy unit of claim 18, wherein the carrier has a nut with internal threads, and the cutting sheath has a threaded spindle threadably engaged with the internal threads of the nut, the cutting sheath having a gear coupled to the threaded spindle to rotatably drive the threaded spindle when the gear is rotated.

20. The disposable biopsy unit of claim 16, wherein the biopsy needle includes a narrowing positioned in the lumen of the biopsy needle at a proximal end of the sample removal chamber, the narrowing being positioned at a top portion of the lumen, leaving a passage at a bottom portion of the lumen.