Devicor Medical Products, Inc.

Ethicon Endo-surgery, Inc.

Robert F Weikel

John A Hibner

Foster B Stulen

Trevor W V Speeg

Gavin Martin Monson

Michael Robert Ludzack

Wells D Haberstich

Bennie Thompson

Lee E Reichel

Richard P Nuchols

Gregory W Johnson

Shailendra Kumar Parihar

Patrick Allen Mescher

Raj G Raghavendran

Kyle P Moore

William D Dannaher

Edward A Rhad

Michael J Andreyko

Michele D'Arcangelo

Eric B Smith

William A Garrison

Paul G Ritchie

Gwendolyn Perez Payne

Peter Neil Morgan

Kenneth E Hogue

John R Andrisek

Michael E Johnson

Trevor V W Speeg

Michele D'arcangelo

Trevor WV Speeg

A biopsy device comprises a probe body, a cannula extending distally from the probe body, a cutter moveable relative to the cannula to sever tissue, and a tissue sample holder coupled with the probe body. The tissue sample holder comprises a rotatable member having a plurality of recesses to receive tissue samples. The rotatable member can be operable to successively index each recess relative to a lumen defined by the cutter. A cover portion may be associated with the rotatable member and permits one or more recesses to be viewable through the cover. The recesses may be configured to carry one or more tissue samples as the rotatable member is rotated.

Biopsy device with rotatable tissue sample holder

A biopsy device and method are provided for obtaining a tissue sample, such as a breast tissue biopsy sample. The biopsy device may include an outer cannula having a distal piercing tip, a cutter lumen, a side tissue port communicating with the cutter lumen, and at least one fluid passageway disposed distally of the side tissue port. The inner cutter may be advanced in the cutter lumen past the side tissue port to sever a tissue sample. After the tissue sample is severed, and before the inner cutter is retracted proximally of the side tissue port, the cutter may be used to alternately cover and uncover the fluid passageway disposed distally of the side tissue.

Biopsy device with variable side aperture

A biopsy system includes a biopsy device and a vacuum control module. The biopsy device includes a cannula and a cutter that translates relative to the cannula to obtain tissue samples. The vacuum control module includes a source of vacuum in communication with the cutter and a user interface. The user interface includes a first page and a second page. The first page has a first graphical representation to indicate the operational status of the biopsy device and does not accept user inputs to alter the operational status of the biopsy device. The second page has at least one icon to adjust the operational status of the biopsy device indicated on the first page and a second graphical representation to indicate the adjustment to the operational status of the biopsy device. The user interface includes a user input feature to select the first page or the second page.

Icon-based user interface on biopsy system control module

A biopsy device and method are provided for obtaining a tissue sample, such as a breast tissue biopsy sample. The biopsy device includes a disposable probe assembly with an outer cannula having a distal piercing tip, a cutter lumen, and a cutter tube that rotates and translates past a side aperture in the outer cannula to sever a tissue sample. The biopsy device also includes a reusable hand piece with an integral motor and power source to make a convenient, untethered control for use with ultrasonic imaging. External vacuum holes along the outer cannula (probe) that communicate with a vacuum and cutter lumen withdraw bodily fluids while a hemostatic disk-shaped ring pad around the probe applies compression to an external hole in the skin and absorbs fluids.

Biopsy device with vacuum assisted bleeding control

A biopsy device includes an elongate needle, a proximal portion, a cutter, and a vacuum conduit. The elongate needle defines an internal passage and includes a distal end and a first plurality of openings along an exterior surface of the elongate needle in communication with the internal passage. The first plurality of openings are sized to admit fluid and to resist the prolapse of tissue. The proximal portion is attached to the elongate needle and is positionable to insert the elongate needle into tissue. The cutter is reciprocally received by the elongate needle to sever a tissue sample received in the elongate needle. The cutter includes a cutter tube with a second plurality of openings in communication with the internal passage of the elongate needle. The vacuum conduit is attached to the proximal portion in communication with the internal passage and is coupled to a vacuum source.

A biopsy device includes a body portion, a tip, at least one blade, and a cutter. The cannula defines at least one lumen. The cannula has a transverse aperture configured to receive tissue. The tip is located at the distal end of the cannula, and may include at least two concave surfaces. The blade extends longitudinally from the tip. A second blade may also extend longitudinally from the tip. Blades may be axially staggered relative to the cannula. Blades may also have lengths that differ from one another. In addition, a blade may have a pointed distal end, or may have a curved distal edge. The configuration of the blade and tip may provide reduced force to penetrate tissue. The blade and tip may produce a cut length that is greater than or equal to the length of the outer perimeter of the cannula.

Needle tip for biopsy device

A vacuum control module for use in a biopsy system includes a user interface that presents buttons and icons to control operation of a biopsy device. The icons may indicate, e.g., the position of a cutter relative to a transverse opening, whether the system is in a view sample mode, that an adjacent button is operable to reset the position of a rotatable tissue sample holder, whether the system is in a maintenance vacuum pulse mode, the level of vacuum provided by a vacuum source, the volume level of a speaker, that an adjacent button is operable to place the system in a standby mode, and that an adjacent button is operable to shut down the system. The icons may each have an associated button. The icons may be allocated among separate pages (e.g., a probe page and a system page). Another button may be used to switch between pages.

A biopsy device includes a cutter defining a cutter lumen and a tissue sample holder for collecting tissue samples. In one example, the tissue sample holder has a rotatable manifold that is configured to redirect fluid from one axial direction to an opposite axial direction. The tissue sample holder also has a plurality of tissue sample trays through which fluid may be communicated. The tissue sample trays define chambers that are each configured to separately hold tissue samples. The tissue sample trays are removable relative to the manifold. A cup is configured to cover the manifold and trays. A tissue sample holder rotation mechanism is operable to rotate the manifold to successively index each chamber of the tissue sample trays with the cutter lumen. A feature may prevent rotation of the manifold when one part of the biopsy device is separated from another part of the biopsy device.

Revolving tissue sample holder for biopsy device

A biopsy device comprises a probe body, a cannula extending distally from the probe body, a cutter moveable relative to the cannula to sever tissue, and a tissue sample holder coupled with the probe body. The tissue sample holder comprises a rotatable member and at least one removable member secured about the exterior of the rotatable member. The at least one removable member defines a plurality of tissue sample compartments. Each tissue sample compartment is configured to receive one or more tissue samples captured by the cutter. In some versions, the at least one removable member comprises a belt and a plurality of vials.

A biopsy system has a cutter defining a cutter lumen along an axis. One conduit in the system is configured to provide fluid communication along the cutter lumen axis; while another conduit in the system is configured to provide fluid communication lateral to the cutter lumen axis. The system may be operated in a variety of modes, including a sample cycle, a clear probe cycle, a cutter positioning cycle, an aspirate cycle, and a maintenance vacuum pulse cycle. The operational modes are selectable by a user. Depending on the mode selected by the user, the communication of vacuum, saline, or atmospheric air through the conduits, or the sealing of the conduits, will vary as a function of the axial position of the cutter.

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Hamilton, OH, United States of America

Robert F Weikel