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US20050065453A1 Expired / Lapsed US ⏱️ 0.0 years remaining

Biopsy device with selectable tissue receiving aperture orientation and site illumination

Assignee: SenoRx Inc
•
Filing: 2004-08-03
•
Granted: —
•
Expires: 2024-08-03
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Abstract

Abstract The invention is directed to a system and device for separating and collecting a tissue specimen from a target site within a patient. The device includes a probe component with an elongated tubular section, a penetrating distal tip and a tissue receiving aperture in the distal end of the tubular section proximal to the distal tip, and a tissue cutting member which is slidably disposed within the probe member to cut a tissue specimen drawn into the interior of the device through the aperture by applying a vacuum to the inner lumen of the tissue cutting member. The device also has a driver component to which the probe component is releasably secured. The driver has a drive member for adjusting the orientation of the tubular section and thus the aperture therein and one or more drive members for moving the tissue cutting member within the tubular section to sever a tissue specimen from tissue extending into the interior of the tubular section through the aperture. The motion imparted to the tissue cutter is at least longitudinal and preferably is also oscillation and/or rotational to effectively separate a tissue specimen from tissue extending through the aperture in the tubular section.

Inventors

  • 👤 Martin Shabaz
  • 👤 Richard Quick
  • 👤 Frank Louw
  • 👤 Paul Lubock
  • 👤 Jason Safabash

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 00:47
CPC Classifications
A; A61; A61B; A61B10/00; A61B10/02; A61B10/0233; A61B10/0266; A61B10/0275; A61B90/00; A61B90/30; A61M; A61M1/00; A61M1/71; A61M1/77; A61M1/90; A61M1/92; A61B10/0283; A61B17/00; A61B17/32; A61B17/320016; A61B17/32002; A61B17/34; A61B17/3417; A61B2010/0208; A61B2010/0225; A61B2017/0046; A61B2017/00473; A61B2017/00477; A61B2017/00486; A61B17/3403; A61B2017/3405; A61B2017/3454; A61B90/08; A61B2090/0807; A61B2090/0811; A61B2090/309; A61B90/39; A61B2090/3904; A61B2090/3908; A61B2090/3987; B; B23; B23Q; B23Q17/00; B23Q17/24; B23Q17/2404; F; F21; F21V; F21V33/00; F21V33/0064; F21V33/0068

Claims Analysis

Total Claims: 65
Claim 1
Independent Claim 200 words
1 . A tissue biopsy system for accessing and collecting one or more tissue specimens from a target site within a patient, comprising: a. a disposable elongated probe component comprising i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, a proximal extremity configured to be secured to a driver unit, and ii. an elongated tissue cutting member which is disposed within the tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein; and b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut tissue extending into the tubular section through the tissue receiving aperture thereof.
Claim 2
Dependent Claim 200 words
1 . A tissue biopsy system for accessing and collecting one or more tissue specimens from a target site within a patient, comprising: a. a disposable elongated probe component comprising i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, a proximal extremity configured to be secured to a driver unit, and ii. an elongated tissue cutting member which is disposed within the tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein; and b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut tissue extending into the tubular section through the tissue receiving aperture thereof.
Claim 3
Dependent Claim 27 words
2 . The system of claim 1 wherein the driver component has a third driver motor configured to rotate the tissue cutting member within the tubular section.
Claim 4
Dependent Claim 29 words
3 . The system of claim 2 wherein the third driver motor rotates the tissue cutting member within the tubular section as the tissue cutting member moves longitudinally therein.
Claim 5
Dependent Claim 27 words
4 . The system of claim 1 wherein the driver component has a third driver motor configured to oscillate the tissue cutting member within the tubular section.
Claim 6
Dependent Claim 29 words
5 . The system of claim 4 wherein the third driver motor oscillates the tissue cutting member within the tubular section as the tissue cutting member moves longitudinally therein.
Claim 7
Dependent Claim 28 words
6 . The system of claim 1 including a vacuum source connected in fluid communication with the inner lumen of the tissue cutting member to withdraw tissue therethrough.
Claim 8
Dependent Claim 34 words
7 . The system of claim 6 wherein a tissue collector is in fluid communication with the inner lumen of the tissue cutting member configured to receive tissue withdrawn through the tissue cutting member.
Claim 9
Dependent Claim 22 words
8 . The system of claim 7 wherein the tissue collector is located between the tissue cutting member and the vacuum source.
Claim 10
Dependent Claim 27 words
9 . The system of claim 1 wherein the first driving motor is configured to rotate the tubular section in discrete steps about the longitudinal axis thereof.
Claim 11
Dependent Claim 26 words
10 The system of claim 9 wherein the first driving motor is configured to rotate the tubular section in increments of about 15° to about 45°.
Claim 12
Dependent Claim 24 words
11 . The system of claim 9 wherein the first driving motor is configured to rotate the tubular section in increments of about 30°.
Claim 13
Dependent Claim 24 words
12 . The system of claim 1 wherein the distal extremity of the tubular section of the probe component has a circular transverse cross-section.
Claim 14
Dependent Claim 31 words
13 . The system of claim 1 including a protective tube which has proximal and distal ends, which has an inner lumen extending therein, which is disposed about the tubular section.
Claim 15
Dependent Claim 16 words
14 . The system of claim 13 wherein the protective tube has multiple longitudinally oriented lobes.
Claim 16
Dependent Claim 22 words
15 . The system of claim 1 wherein the driver component has at least one illuminating element in a distal portion thereof.
Claim 17
Dependent Claim 19 words
16 . The system of claim 15 wherein the at least one illuminating element is a light emitting diode.
Claim 18
Dependent Claim 15 words
17 . The system of claim 15 wherein the driver component has two illuminating elements.
Claim 19
Dependent Claim 19 words
18 . The system of claim 15 wherein the at least one illuminating element has a manually operable switch.
Claim 20
Dependent Claim 22 words
19 . The system of claim 18 wherein the manually operable switch is located in the distal end of the driver component.
Claim 21
Dependent Claim 18 words
20 . The system of claim 1 wherein at least one of the driving motors are electrically powered.
Claim 22
Dependent Claim 18 words
21 . The system of claim 1 wherein at least one of the driving motors are hydraulically powered.
Claim 23
Dependent Claim 18 words
22 . The system of claim 1 wherein at least one of the driving motors are pneumatically powered.
Claim 24
Dependent Claim 20 words
23 . The system of claim 1 including a control module which has an electrical source and a vacuum source.
Claim 25
Dependent Claim 18 words
24 . The system of claim 23 wherein the control module controls the rotation of the tubular section.
Claim 26
Dependent Claim 24 words
25 . The biopsy system of claim 1 wherein the driver component is configured for mounting onto a stereotactic stage of a mammography system.
Claim 27
Dependent Claim 234 words
26 . A tissue biopsy system for accessing and collecting one or more tissue specimens from a target site within a patient, comprising: a. a disposable elongated probe component comprising i. an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a tissue penetrating distal tip and which has an aperture proximal to the penetrating distal tip configured to receive tissue from the target site, and ii. an elongated tissue cutting member which is disposed within the elongated tubular section, which has at least one tissue cutting edge, which has an inner lumen extending therein and which is configured to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member; b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section, which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section of the probe to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member; and c. at least one light source in a distal portion of the driver component for illuminating an operation site.
Claim 28
Dependent Claim 234 words
26 . A tissue biopsy system for accessing and collecting one or more tissue specimens from a target site within a patient, comprising: a. a disposable elongated probe component comprising i. an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a tissue penetrating distal tip and which has an aperture proximal to the penetrating distal tip configured to receive tissue from the target site, and ii. an elongated tissue cutting member which is disposed within the elongated tubular section, which has at least one tissue cutting edge, which has an inner lumen extending therein and which is configured to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member; b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section, which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section of the probe to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member; and c. at least one light source in a distal portion of the driver component for illuminating an operation site.
Claim 29
Dependent Claim 24 words
27 . The biopsy system of claim 26 wherein the driver component is configured for mounting onto a stereotactic stage of a mammography system.
Claim 30
Dependent Claim 24 words
28 . The biopsy system of claim 26 wherein the driver component has a third driving motor configured to rotate the tissue cutting member.
Claim 31
Dependent Claim 31 words
29 . The biopsy system of claim 28 wherein the third driving motor is configured to rotate the tissue cutting member as the member is moved longitudinally within the tubular section.
Claim 32
Dependent Claim 19 words
30 . The system of claim 26 wherein the at least one illuminating element is a light emitting diode.
Claim 33
Dependent Claim 15 words
31 . The system of claim 26 wherein the driver component has two illuminating elements.
Claim 34
Dependent Claim 19 words
32 . The system of claim 26 wherein the at least one illuminating elements has a manually operable switch.
Claim 35
Dependent Claim 22 words
33 . The system of claim 32 wherein the manually operable switch is located in the distal end of the driver component.
Claim 36
Dependent Claim 24 words
34 . The system of claim 26 including a vacuum source connected in fluid communication with the inner lumen of the tissue cutting member.
Claim 37
Dependent Claim 24 words
35 . The system of claim 34 wherein a tissue collector is in fluid communication with the inner lumen of the tissue cutting member.
Claim 38
Dependent Claim 22 words
36 . The system of claim 35 wherein the tissue collector is located between the tissue cutting member and the vacuum source.
Claim 39
Dependent Claim 289 words
37 . A method for collecting one or more tissue specimens from a target site within a patient, comprising: a. providing a biopsy device having: i. a disposable elongated probe component comprising an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a penetrating distal tip and which has an aperture proximal to the penetrating distal tip configured to receive tissue from the target site, and an elongated tissue cutting member which is disposed within the elongated tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein; and ii. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member; b. advancing the probe component at least partially into or adjacent to tissue at the target site; c. rotating the tubular section about its longitudinal axis to provide a desired aperture orientation; d. applying a vacuum within the tubular section to draw tissue at the tissue site through the aperture of the tubular section into the interior thereof; e. advancing the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from the tissue extending into the tubular section; and f. transporting a cut tissue specimen through the inner lumen of the tissue cutting member.
Claim 40
Dependent Claim 289 words
37 . A method for collecting one or more tissue specimens from a target site within a patient, comprising: a. providing a biopsy device having: i. a disposable elongated probe component comprising an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a penetrating distal tip and which has an aperture proximal to the penetrating distal tip configured to receive tissue from the target site, and an elongated tissue cutting member which is disposed within the elongated tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein; and ii. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member; b. advancing the probe component at least partially into or adjacent to tissue at the target site; c. rotating the tubular section about its longitudinal axis to provide a desired aperture orientation; d. applying a vacuum within the tubular section to draw tissue at the tissue site through the aperture of the tubular section into the interior thereof; e. advancing the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from the tissue extending into the tubular section; and f. transporting a cut tissue specimen through the inner lumen of the tissue cutting member.
Claim 41
Dependent Claim 21 words
38 . The method of claim 37 wherein the longitudinal motion of the tissue cutting member includes rotational or oscillation motion.
Claim 42
Dependent Claim 21 words
39 . The method of claim 37 wherein the tubular section is rotated about its longitudinal axis in discrete rotational increments.
Claim 43
Dependent Claim 18 words
40 . The method of claim 37 wherein the discrete rotational increments are about 15° to about 45°.
Claim 44
Dependent Claim 15 words
41 . The method of claim 40 wherein the discrete rotational increments are about 90°.
Claim 45
Dependent Claim 180 words
42 . A tissue biopsy probe device for accessing one or more tissue specimens from a target site within a patient, comprising: a. an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a distal tip and which has an aperture proximal to the distal tip configured to receive tissue from the target site, and b. an elongated tissue cutting member which is slidably disposed within the elongated tubular section, which has a distal end with at least one tissue cutting edge, which has an inner lumen extending therein and which is configured for longitudinal movement within the tubular section; and c. a proximal housing which contains a proximal portion of the elongated tissue cutting member, a driving shuttle secured to the proximal portion of the elongated tissue cutting member and a first drive member engaging the shuttle to move the elongated tissue cutting member and a second drive member secured to a proximal portion of the tubular section within the housing configured to rotate the tubular section about its longitudinal axis.
Claim 46
Dependent Claim 180 words
42 . A tissue biopsy probe device for accessing one or more tissue specimens from a target site within a patient, comprising: a. an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a distal tip and which has an aperture proximal to the distal tip configured to receive tissue from the target site, and b. an elongated tissue cutting member which is slidably disposed within the elongated tubular section, which has a distal end with at least one tissue cutting edge, which has an inner lumen extending therein and which is configured for longitudinal movement within the tubular section; and c. a proximal housing which contains a proximal portion of the elongated tissue cutting member, a driving shuttle secured to the proximal portion of the elongated tissue cutting member and a first drive member engaging the shuttle to move the elongated tissue cutting member and a second drive member secured to a proximal portion of the tubular section within the housing configured to rotate the tubular section about its longitudinal axis.
Claim 47
Dependent Claim 56 words
43 . The tissue biopsy probe device of claim 42 wherein the first drive member has first and second interfitting tubular drive elements with the first tubular drive element having a threaded interior and with the second tubular drive element having a threaded exterior configured to engage the threaded interior of the first tubular drive element.
Claim 48
Dependent Claim 34 words
44 . The tissue biopsy probe device of claim 43 wherein the first tubular drive element is configured to be rotated and the second tubular drive element is fixed to the tissue cutting member.
Claim 49
Dependent Claim 22 words
45 . The tissue biopsy probe device of claim 44 wherein the second tubular drive element is fixed to the driving shuttle.
Claim 50
Dependent Claim 39 words
46 . The tissue biopsy probe device of claim 42 wherein a marker element is secured to the tubular section adjacent the distal face of the probe housing to indicate the orientation of the aperture in the tubular section.
Claim 51
Dependent Claim 194 words
47 . A tissue biopsy system for collecting one or more tissue specimens from a target site within a patient, comprising: a. a disposable elongated probe component comprising i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, a proximal extremity configured to be secured to a driver unit, and ii. an elongated tissue cutting member which is disposed about the tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein; and b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally to cut tissue extending into the tubular section through the tissue receiving aperture thereof.
Claim 52
Dependent Claim 194 words
47 . A tissue biopsy system for collecting one or more tissue specimens from a target site within a patient, comprising: a. a disposable elongated probe component comprising i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, a proximal extremity configured to be secured to a driver unit, and ii. an elongated tissue cutting member which is disposed about the tubular section, which has at least one tissue cutting edge and which has an inner lumen extending therein; and b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally to cut tissue extending into the tubular section through the tissue receiving aperture thereof.
Claim 53
Dependent Claim 23 words
48 . The system of claim 47 wherein the driver component has a third driver motor configured to rotate the tissue cutting member.
Claim 54
Dependent Claim 24 words
49 . The system of claim 48 wherein the third driver motor rotates the tissue cutting member as the tissue cutting member moves longitudinally.
Claim 55
Dependent Claim 23 words
50 . The system of claim 47 wherein the driver component has a third driver motor configured to oscillate the tissue cutting member.
Claim 56
Dependent Claim 24 words
51 . The system of claim 48 wherein the third driver motor oscillates the tissue cutting member as the tissue cutting member moves longitudinally.
Claim 57
Dependent Claim 31 words
52 . The system of claim 48 including a vacuum source connected in fluid communication with the inner lumen of the tubular section of the probe component to withdraw tissue therethrough.
Claim 58
Dependent Claim 225 words
53 . A tissue biopsy system for collecting one or more tissue specimens from a target site within a patient, comprising: a. a disposable elongated probe component comprising i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site and a proximal extremity configured to be secured to a driver unit, and ii. an elongated tissue cutting member which is disposed about the tubular section, which has at least one tissue cutting edge, which has an inner lumen extending therein and which has a proximal end configured to receive a distal tip of a marker delivery device with a flared guide to guide the distal tip into the proximal end of the tissue cutting member; and b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally to cut tissue extending through the tissue receiving aperture thereof.
Claim 59
Dependent Claim 225 words
53 . A tissue biopsy system for collecting one or more tissue specimens from a target site within a patient, comprising: a. a disposable elongated probe component comprising i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site and a proximal extremity configured to be secured to a driver unit, and ii. an elongated tissue cutting member which is disposed about the tubular section, which has at least one tissue cutting edge, which has an inner lumen extending therein and which has a proximal end configured to receive a distal tip of a marker delivery device with a flared guide to guide the distal tip into the proximal end of the tissue cutting member; and b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally to cut tissue extending through the tissue receiving aperture thereof.
Claim 60
Dependent Claim 132 words
54 . A device for delivery of one or more marker bodies through a tubular member of a biopsy device, comprising: a. an elongated shaft having an inner lumen and a discharge opening in a distal portion of the elongated shaft; b. at least one marker body which is disposed within the inner lumen of the elongated shaft; c. a pusher element which is slidably disposed within the delivery device and which is configured to urge at least one marker body out the discharge opening in the distal portion of the elongated shaft; and d. a distally flared guide member which is disposed on the elongated shaft and which is configured to guide the distal portion of the elongated shaft into a proximal end of a tubular member of a biopsy device.
Claim 61
Dependent Claim 132 words
54 . A device for delivery of one or more marker bodies through a tubular member of a biopsy device, comprising: a. an elongated shaft having an inner lumen and a discharge opening in a distal portion of the elongated shaft; b. at least one marker body which is disposed within the inner lumen of the elongated shaft; c. a pusher element which is slidably disposed within the delivery device and which is configured to urge at least one marker body out the discharge opening in the distal portion of the elongated shaft; and d. a distally flared guide member which is disposed on the elongated shaft and which is configured to guide the distal portion of the elongated shaft into a proximal end of a tubular member of a biopsy device.
Claim 62
Dependent Claim 401 words
55 . A tissue biopsy system for collecting at least one tissue specimen from a target site within a patient and delivering at least one marker to the target site after the at least one tissue specimen has been removed from the site, comprising: a. a disposable elongated probe component comprising i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, and a proximal extremity configured to be secured to a driver unit, and ii. an elongated tubular tissue cutting member which has at least one tissue cutting edge at a distal end, which has an opening at a proximal end and which has an inner lumen extending therein to the opening in the proximal end; b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which [has a first driver motor] is configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which [has a second driver motor] is configured to drive the tissue cutting member longitudinally to cut tissue extending into the tubular section through the tissue receiving aperture thereof; and c. a marker delivery component for delivery of at least one marker bodies through the tubular tissue cutting member, including: i. an elongated shaft which has an inner lumen, a discharge opening in a distal portion of the elongated shaft and an outer diameter smaller than the inner diameter of the tubular tissue cutting member of the probe component; ii. at least one marker body which is disposed within the inner lumen of the elongated shaft; iii. a pusher element which is slidably disposed within the delivery device and which is configured to urge at least one marker body out the discharge opening in the distal portion of the elongated shaft; and iv. a distally flared guide member which is disposed on the elongated shaft, which has a distal diameter much greater than the outer diameter of the proximal end of the tubular tissue cutting member and which is configured to guide the distal portion of the elongated shaft into the proximal end of the tubular cutting member.
Claim 63
Dependent Claim 401 words
55 . A tissue biopsy system for collecting at least one tissue specimen from a target site within a patient and delivering at least one marker to the target site after the at least one tissue specimen has been removed from the site, comprising: a. a disposable elongated probe component comprising i. a distal shaft portion with a penetrating distal tip, a tubular section proximal to the distal tip, an inner lumen extending within the tubular section and an open, tissue receiving aperture in the tubular section which provides access to tissue at the targeted site, and a proximal extremity configured to be secured to a driver unit, and ii. an elongated tubular tissue cutting member which has at least one tissue cutting edge at a distal end, which has an opening at a proximal end and which has an inner lumen extending therein to the opening in the proximal end; b. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which [has a first driver motor] is configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which [has a second driver motor] is configured to drive the tissue cutting member longitudinally to cut tissue extending into the tubular section through the tissue receiving aperture thereof; and c. a marker delivery component for delivery of at least one marker bodies through the tubular tissue cutting member, including: i. an elongated shaft which has an inner lumen, a discharge opening in a distal portion of the elongated shaft and an outer diameter smaller than the inner diameter of the tubular tissue cutting member of the probe component; ii. at least one marker body which is disposed within the inner lumen of the elongated shaft; iii. a pusher element which is slidably disposed within the delivery device and which is configured to urge at least one marker body out the discharge opening in the distal portion of the elongated shaft; and iv. a distally flared guide member which is disposed on the elongated shaft, which has a distal diameter much greater than the outer diameter of the proximal end of the tubular tissue cutting member and which is configured to guide the distal portion of the elongated shaft into the proximal end of the tubular cutting member.
Claim 64
Dependent Claim 665 words
56 . A method for collecting one or more tissue specimens from a target site within a patient and delivering at least one marker body to the target site, comprising: a. providing a biopsy device having: i. a disposable elongated probe component comprising an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a penetrating distal tip and which has an aperture proximal to the penetrating distal tip configured to receive tissue from the target site, and an elongated tissue cutting member which is disposed within the elongated tubular section, which has at least one tissue cutting edge, which has an inner lumen extending therein and which is disposed within the tubular tissue cutting member with the cutting edge distal to the aperture opening so as to close the opening; and ii. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member; b. advancing the probe component at least partially into or adjacent to tissue at the target site with the tissue receiving aperture closed by the tissue cutter; c. rotating the tubular section of the probe component about its longitudinal axis to provide a desired orientation to the tissue receiving aperture; d. withdrawing the tissue cutter distally to open a desired length of the tissue receiving aperture; e. applying a vacuum within the tubular section to draw tissue at the tissue site through the tissue receiving aperture of the tubular section into the interior thereof; f. advancing the tissue cutting member distally within the tubular section of the probe member to cut a tissue specimen from the tissue extending into the tubular section; and g. transporting a cut tissue specimen through the inner lumen of the tissue cutting member and out a discharge opening in the proximal end thereof; h. providing a marker delivery device for delivery of at least one marker bodies through the tubular tissue cutting member, including: i. an elongated shaft which has an inner lumen, a discharge opening in a distal portion of the elongated shaft and an outer diameter smaller than the inner diameter of the tubular tissue cutting member of the probe component; ii. at least one marker body which is disposed within the inner lumen of the elongated shaft; iii. a pusher element which is slidably disposed within the delivery device and which is configured to urge at least one marker body out the discharge opening in the distal portion of the elongated shaft; and iv. a distally flared guide member which is disposed on the elongated shaft, which has a distal diameter much greater than the outer diameter of the proximal end of the tubular tissue cutting member and which is configured to guide the distal portion of the elongated shaft into the proximal end of the tubular cutting member; i. advancing the marker delivery device toward the proximal end of the tubular tissue cutting member of the probe component until the distal end of the flared guide surrounds the proximal end of the tubular tissue cutting member; j. further advancing the marker delivery device so the elongated shaft thereof extends into the inner lumen of the tubular tissue cutting member and the discharge opening in the shaft of the marker delivery device is aligned with the tissue receiving aperture of the outer tubular member; and k. pressing the pusher element of the marker delivery device to eject at least on marker body through the discharge opening in the marker delivery device, through the tissue receiving aperture and into the target site.
Claim 65
Dependent Claim 665 words
56 . A method for collecting one or more tissue specimens from a target site within a patient and delivering at least one marker body to the target site, comprising: a. providing a biopsy device having: i. a disposable elongated probe component comprising an elongated tubular section which has a longitudinal axis, which has an inner lumen extending therein, which has a penetrating distal tip and which has an aperture proximal to the penetrating distal tip configured to receive tissue from the target site, and an elongated tissue cutting member which is disposed within the elongated tubular section, which has at least one tissue cutting edge, which has an inner lumen extending therein and which is disposed within the tubular tissue cutting member with the cutting edge distal to the aperture opening so as to close the opening; and ii. a driver component which is configured to receive a proximal portion of the probe component in an operational relationship, which has a first driver motor configured to rotate the tubular section of the probe component to orient the tissue receiving aperture in the distal end of the tubular section and which has a second driver motor configured to drive the tissue cutting member longitudinally within the tubular section to cut a tissue specimen from tissue extending into the tissue receiving aperture of the elongated tubular member; b. advancing the probe component at least partially into or adjacent to tissue at the target site with the tissue receiving aperture closed by the tissue cutter; c. rotating the tubular section of the probe component about its longitudinal axis to provide a desired orientation to the tissue receiving aperture; d. withdrawing the tissue cutter distally to open a desired length of the tissue receiving aperture; e. applying a vacuum within the tubular section to draw tissue at the tissue site through the tissue receiving aperture of the tubular section into the interior thereof; f. advancing the tissue cutting member distally within the tubular section of the probe member to cut a tissue specimen from the tissue extending into the tubular section; and g. transporting a cut tissue specimen through the inner lumen of the tissue cutting member and out a discharge opening in the proximal end thereof; h. providing a marker delivery device for delivery of at least one marker bodies through the tubular tissue cutting member, including: i. an elongated shaft which has an inner lumen, a discharge opening in a distal portion of the elongated shaft and an outer diameter smaller than the inner diameter of the tubular tissue cutting member of the probe component; ii. at least one marker body which is disposed within the inner lumen of the elongated shaft; iii. a pusher element which is slidably disposed within the delivery device and which is configured to urge at least one marker body out the discharge opening in the distal portion of the elongated shaft; and iv. a distally flared guide member which is disposed on the elongated shaft, which has a distal diameter much greater than the outer diameter of the proximal end of the tubular tissue cutting member and which is configured to guide the distal portion of the elongated shaft into the proximal end of the tubular cutting member; i. advancing the marker delivery device toward the proximal end of the tubular tissue cutting member of the probe component until the distal end of the flared guide surrounds the proximal end of the tubular tissue cutting member; j. further advancing the marker delivery device so the elongated shaft thereof extends into the inner lumen of the tubular tissue cutting member and the discharge opening in the shaft of the marker delivery device is aligned with the tissue receiving aperture of the outer tubular member; and k. pressing the pusher element of the marker delivery device to eject at least on marker body through the discharge opening in the marker delivery device, through the tissue receiving aperture and into the target site.

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