Biopsy device

• US 10,285,673 B2
• Filed: 03/19/2014
• Issued: 05/14/2019
• Est. Priority Date: 03/20/2013
• Status: Active Grant

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Inventors: Orts, Soren Falkesgaard, Sonnenborg, Frederik, Jensen, Per Rosenberg, Larsen, Brian Kim
• Primary Examiner(s): Towa, Rene T
• Application Number:
  US14/772,994
• Publication Number:
  US 20160317133A1
• Time in Patent Office: 1,882 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 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 2017/2923 Toothed members, e.g. rack and pinion

Abstract

A biopsy device for obtaining tissue samples from human or animal tissue is optimized for the sampling of tissues that are resilient and difficult to cut using conventional approaches. The biopsy device includes a cutting cannula, an inner member including a toothed rack having a sharpened distal tip configured to be introduced into the body and a sample notch for receiving the at least one severed tissue sample, the inner member receivable in the cutting cannula, and a cutting mechanism configured for causing the cutting cannula to be longitudinally displaced in a distal direction from a first position at the proximal end of the sample notch exposing the sample notch, to a second position at the distal end of the sample notch, so as to sever said tissue sample from remaining body tissue at the harvesting site. The toothed rack may be a rotatable and may be rigid.

Claims

1. A biopsy device for harvesting at least one tissue sample from a suspect tissue mass in a body of a living being, comprising:

a cutting cannula that is hollow;

an inner member including a rotatable toothed rack having a sharpened distal tip configured to be introduced into the body and a sample notch configured to receive tissue at a harvesting site in the body, the inner member configured to be received in the cutting cannula, the rotatable toothed rack having a proximal portion and a rotation zone in the proximal portion with circumferential toothing configured to facilitate both a longitudinal movement and a rotational movement of the rotatable toothed rack;

a drive configured to engage the circumferential toothing to move the rotatable toothed rack within the cutting cannula in at least one of the longitudinal movement and the rotational movement; and

a cutting mechanism configured to cause the cutting cannula to be longitudinally displaced in a distal direction from a first position at the proximal end of the sample notch wherein the sample notch is exposed, to a second position at the distal end of the sample notch, so as to sever the tissue received by the sample notch at the harvesting site to form a tissue sample,

wherein the inner member further comprises a circumferential protrusion located between the sharpened distal end and the sample notch, the circumferential protrusion formed to match the distal end of the cutting cannula.

2. The biopsy device of claim 1, wherein the protrusion is formed in a material that is softer than the cutting cannula.

3. The biopsy device of claim 2, wherein the circumferential protrusion is configured to form a cutting surface for the cutting cannula during severing of the tissue sample.

4. The biopsy device of claim 1, wherein the cutting mechanism is configured such that the cutting cannula and the circumferential protrusion encounter during severing of a tissue sample.

5. The biopsy device of claim 1, wherein the cutting mechanism is configured such that the cutting cannula and the circumferential protrusion do not encounter during severing of the tissue sample.

6. The biopsy device of claim 1, wherein the cutting mechanism is configured such that the cutting cannula and the circumferential protrusion is brought into close proximity without encountering during severing of a tissue sample.

7. A biopsy device for harvesting at least one tissue sample from a suspect tissue mass in a body of a living being, comprising:

a cutting cannula that is hollow;

an inner member including a rotatable toothed rack having a sharpened distal tip configured to be introduced into the body and a sample notch configured to receive tissue at a harvesting site in the body, the inner member configured to be received in the cutting cannula, the rotatable toothed rack having a proximal portion and a rotation zone in the proximal portion with circumferential toothing configured to facilitate both a longitudinal movement and a rotational movement of the rotatable toothed rack;

a drive configured to engage the circumferential toothing to move the rotatable toothed rack within the cutting cannula in at least one of the longitudinal movement and the rotational movement; and

a cutting mechanism configured to cause the cutting cannula to be longitudinally displaced in a distal direction from a first position at the proximal end of the sample notch wherein the sample notch is exposed, to a second position at the distal end of the sample notch, so as to sever the tissue received by the sample notch at the harvesting site to form a tissue sample,

wherein the cutting mechanism is configured to provide a predefined overshoot during severing of a tissue sample such that the distal end of the cutting cannula passes beyond the distal end of the sample notch temporarily before returning to the second position, and

wherein the cutting mechanism comprises an elastic element in connection with the cutting cannula and is configured to provide the overshoot.

8. The biopsy device of claim 7, wherein the elastic element comprises at least one damper spring mounted in a damper spring housing.

9. The biopsy device of claim 7, wherein the elastic element comprises at least one damping element formed in rubber.

10. A method of operating a biopsy device to obtain at least one biopsy tissue sample from a body of a living being, the method comprising:

providing an assembly comprising a hollow cutting cannula and an inner member movably disposed in the cutting cannula, the inner member including a rigid toothed rack having a sharpened distal tip configured to be introduced into the body and a sample notch configured to receive tissue at a sample harvest site in the body, the rigid toothed rack having a proximal portion and a rotation zone in the proximal portion with circumferential toothing configured to facilitate both longitudinal movement and a rotational movement of the rotatable toothed rack;

introducing a distal end portion of the hollow cutting cannula into the body, so as to place the distal end portion near a suspect tissue mass, the hollow cutting cannula comprising a cutting edge, the rigid toothed rack being movable in a longitudinal direction in the cutting cannula between a first extended position, in which a distal end of the sample notch projects from a distal tip of the cutting cannula, and a second retracted position, which is proximal with respect to the first position;

activating a firing mechanism to thereby cause the cutting cannula and the rigid toothed rack to be longitudinally displaced in a distal direction, so as to cause a tip of the rigid toothed rack and the distal end portion of the cutting cannula to penetrate the suspect tissue mass;

retracting the cutting cannula to a first position, in which the sample notch projects from the distal end of the cutting cannula;

activating a cutting mechanism to thereby cause the cutting cannula to be longitudinally displaced in a distal direction from the first position at the proximal end of the sample notch exposing the sample notch, to a second position at the distal end of the sample notch, so as to sever the tissue sample from remaining body tissue at the harvesting site;

moving the rigid toothed rack in the cutting cannula to the second retracted position;

collecting the first tissue sample from the sample notch, when the rigid toothed rack is in the second retracted position;

rotating the rigid toothed rack and the cutting cannula simultaneously about their longitudinal axis relative to the biopsy device so as to orient the sample notch towards the suspect tissue mass, prior to activation of the firing mechanism;

rotating the rigid toothed rack about a longitudinal axis relative to the cutting cannula during severing of a tissue sample so as to sever connecting tissue; and

continuously retracting and advancing the rigid toothed rack relative to the cutting cannula during severing of a tissue sample so as to sever connecting tissue in small steps of between 0.1 and 2 mm.

11. The method of claim 10, further comprising the step of activating a vacuum reservoir so as to temporarily increase negative airflow so as to maintain a vacuum level in connection with:

suction of a tissue sample into the sample notch prior to severing, and/or

collection of a tissue sample from the sample notch.