EP0983749A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Excisional biopsy devices and methods
Assignee: Rubicor Medical Inc
•
Filing: 1999-08-20
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Granted: —
•
Expires: 2019-08-20
Abstract
Abstract An excisional biopsy device (100) includes a tubular member (110) having a window (120) near a distal tip (115) thereof; a cutting tool (125), a distal end of the cutting tool being attached near the distal tip of the tubular member, at least a distal portion of the cutting tool (125) being configured to selectively bow out of the window and to retract within the window; and a tissue collection device (260) externally attached at least to the tubular member, the tissue collection device collecting tissue excised by the cutting tool as the biopsy device is rotated and the cutting tool is bowed. An excisional biopsy method for soft tissue includes the steps of inserting a generally tubular member into the tissue, the tubular member including a cutting tool adapted to selectively bow away from the tubular member and an external tissue collection device near a distal tip of the tubular member; rotating the tubular member; selectively varying a degree of bowing of the cutting tool; collecting tissue severed by the cutting tool in the tissue collection device; and retracting the tubular member from the soft tissue. The tubular member may include an imaging transducer (270) and the method may include the step of displaying information received from the transducer on a display device and the step of varying the degree of bowing of the cutting tool based upon the displayed information from the imaging transducer. Alternatively, the imaging transducer (270) may be disposed within a removable transducer core adapted to fit within the tubular member.
Inventors
- 👤 Roberta Lee
- 👤 James W. Vetter
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-26 13:38
CPC Classifications
A; A61; A61B; A61B8/00; A61B8/08; A61B8/0833; A61B8/085; A61B10/00; A61B10/02; A61B10/0233; A61B10/0266; A61B10/0275; A61B10/04; A61B17/00; A61B17/32; A61B17/3205; A61B17/3207; A61B17/320725; A61B18/00; A61B18/04; A61B18/12; A61B18/14; A61B18/1482; A61B17/00234; A61B2017/00287; A61B2018/00005; A61B2018/00011; A61B2018/1405; A61B2018/1407; A61B2018/1475; A61B90/00; A61B90/36; A61B90/37; A61B2090/378; A61B2090/3782; A61B2090/3784; A61B2218/00; A61B2218/001; A61B2218/002; A61B8/46; A61B8/461
Claims Analysis
Total Claims: 49
Claim 1
Independent Claim
96 words
An excisional biopsy device, comprising: a tubular member having a window near a distal tip thereof; a cutting tool, a distal end of the cutting tool being attached near the distal tip of the
tubular member, at least a distal portion of the cutting tool being configured to selectively
bow out of the window and to retract within the window; and a tissue collection device externally attached at least to the tubular member, the tissue
collection device collecting tissue severed by the cutting tool as the biopsy device is rotated
and the cutting tool is bowed.
Claim 2
Dependent Claim
25 words
The excisional biopsy device of claim 1, wherein the distal portion of the
cutting tool comprises a thin ribbon sharpened on a leading edge thereof.
Claim 3
Dependent Claim
17 words
The excisional biopsy device of claim 2, wherein the leading edge of the thin
ribbon is serrated.
Claim 4
Dependent Claim
46 words
The excisional biopsy device of claim 1, wherein the tubular member comprises
an internal guide allowing a proximal portion of the cutting tool to slide therein when a
proximal end of the cutting tool is pushed in a distal direction or pulled in a proximal
direction.
Claim 5
Dependent Claim
38 words
The excisional biopsy device of claim 1, wherein the cutting tool further
comprises: an interior lumen; and a plurality of through holes in the distal portion thereof, the through holes being in
fluid communication with the interior lumen.
Claim 6
Dependent Claim
22 words
The excisional biopsy device of claim 1, wherein the tissue collection device
comprises a bag within which the severed tissue is collected.
Claim 7
Dependent Claim
24 words
The excisional biopsy device of claim 6, wherein an opening of the bag is at
least co-extensive with the window in the tubular member.
Claim 8
Dependent Claim
29 words
The excisional biopsy device of claim 1, wherein the tissue collection device is
configured to open and to close as the cutting tool is selectively bowed and retracted,
respectively.
Claim 9
Dependent Claim
47 words
The excisional biopsy device of claim 8, wherein the tissue collection device
comprises a bag attached to the tubular member and to a trailing edge of the distal portion of
the cutting tool, the bag opening and closing as the cutting tool is bowed and retracted,
respectively.
Claim 10
Dependent Claim
49 words
The excisional biopsy device of claim 1, further comprising an ultrasound
sensor mounted within the distal portion of the tubular member, the ultrasound sensor being
disposed within the tubular member so as to image tissue about to be cut by the cutting tool as
the biopsy device is rotated.
Claim 11
Dependent Claim
42 words
The excisional biopsy device of claim 10, wherein the ultrasound sensor is
electrically connected to at least one data processing and display device to allow one of a real
time and near real time graphical representation of the tissue to be cut.
Claim 12
Dependent Claim
23 words
The excisional biopsy device of claim 1, wherein the distal portion of the
cutting tool is electrically connected to an RF power source.
Claim 13
Dependent Claim
19 words
The excisional biopsy device of claim 12, wherein the distal portion of the
cutting tool comprises a thin wire.
Claim 14
Dependent Claim
106 words
An invasive interventional device for soft biological tissue, comprising: a rotatable tubular member having a distal tip adapted to penetrate the tissue; a work element disposed near the distal tip of the tubular member, the work element
acting upon the tissue coming into contact therewith as the tubular member rotates; an ultrasound transducer disposed near the distal tip of the tubular member and away
from the work element, so that the transducer sweeps a plane within the tissue ahead of the
work element as the tubular member rotates; and means for controlling an operation of the work element based upon information
gathered from the ultrasound transducer.
Claim 15
Dependent Claim
22 words
The device of claim 14, wherein the ultrasound transducer is tuned within a
range from about 7.5 MHz to about 20 MHz.
Claim 16
Dependent Claim
56 words
The device of claim 14, wherein the ultrasound transducer is disposed within
the tubular member at an angle α relative to the work element, the angle α being no smaller
than that necessary to effectively control the operation of the work element in response to the
information gathered from the transducer as the tubular member rotates.
Claim 17
Dependent Claim
15 words
The device of claim 16, wherein the angle α is less than about 180 degrees.
Claim 18
Dependent Claim
41 words
The device of claim 14, wherein the work element comprises at least one
device selected from the group consisting of: an abrasive device, a reciprocating cutting
device, a bowing cutting device, an electrosurgical device, a laser device and a vibrating
device.
Claim 19
Dependent Claim
57 words
The device of claim 14, wherein the ultrasonic transducer is connected to at
least one data processing and display device to allow an operator of the device to ascertain a
structure of the tissue and to control the operation of the work element before the tissue
comes into contact with the work element as the device rotates.
Claim 20
Dependent Claim
58 words
The device of claim 14, wherein the work element comprises a cutting tool, a
distal end of the cutting tool being attached near the distal tip of the tubular member, at least a
distal portion of the cutting tool being configured to selectively bow out of a window in the
tubular member and to retract within the window.
Claim 21
Dependent Claim
19 words
The device of claim 20, wherein the controlling means include means for
selectively bowing and retracting the cutting tool.
Claim 22
Dependent Claim
23 words
The device of claim 21, wherein the controlling means includes one of a
manually operable push knob and a manually operable turn knob
Claim 23
Dependent Claim
84 words
An excisional biopsy method for soft tissue, comprising the steps of inserting a generally tubular member into the tissue, the tubular member including a
cutting tool adapted to selectively bow away from the tubular member and an external tissue
collection device near a distal tip of the tubular member; rotating the tubular member; selectively varying a degree of bowing of the cutting tool; collecting tissue severed by the cutting tool in the tissue collection device; and retracting the tubular member from the soft tissue.
Claim 24
Dependent Claim
18 words
The method of claim 23, wherein the rotating step is carried out by manually
rotating the tubular member.
Claim 25
Dependent Claim
52 words
The method of claim 23, wherein the tubular member further includes an
imaging transducer and wherein the method further comprises the steps of: displaying information received from the transducer on a display device; and varying the degree of bowing of the cutting tool based upon the displayed information
from the imaging transducer.
Claim 26
Dependent Claim
37 words
The method of claim 25, wherein the cutting tool comprises an electrosurgical
blade and wherein the method further comprises the step of varying a power applied to the
electrosurgical blade based upon information received from the transducer.
Claim 27
Dependent Claim
23 words
The method of claim 23, further comprising the step of stabilizing the soft
tissue in an uncompressed state prior to the inserting step.
Claim 28
Dependent Claim
29 words
The method of claim 23, further comprising the step of controlling the cutting
tool to assume a non-extended state prior to the inserting step and before the retraction step.
Claim 29
Dependent Claim
22 words
The method of claim 28, wherein the tissue collection device assumes a closed
configuration when the cutting tool assumes the non-extended state.
Claim 30
Dependent Claim
35 words
The method of claim 23, wherein the extension of the cutting tool is controlled
by selectively and manually pushing and retracting a proximal end of the cutting tool in the
distal and proximal directions, respectively.
Claim 31
Dependent Claim
46 words
The method of claim 23, wherein the cutting tool comprises an interior lumen
and a plurality of through holes in fluid communication therewith, and wherein the method
further comprises the step of delivering at least one fluid to the tissue via the plurality of
through holes.
Claim 32
Dependent Claim
66 words
An imaging and treatment method for soft tissue, comprising the steps of: inserting a tubular member into the soft tissue, the tubular member including an
ultrasonic transducer mounted near a distal end of the tubular member; rotating the tubular member within the soft tissue; displaying an output of the ultrasonic transducer on a display device; and acting upon the soft tissue based upon the displayed output.
Claim 33
Dependent Claim
25 words
The method of claim 32, wherein the ultrasonic transducer is tuned to within a
frequency range of between about 7.5 MHz to about 20 MHz.
Claim 34
Dependent Claim
26 words
The method of claim 32, wherein the acting step includes a step of excising a
selectively variable volume of soft tissue from a main tissue mass.
Claim 35
Dependent Claim
27 words
The method of claim 34, further including a step of collecting the excised
volume of tissue in a tissue collection device mounted externally to the tubular member.
Claim 36
Dependent Claim
71 words
An excisional biopsy device, comprising: a tubular member having a first and a second window near a distal tip thereof; a cutting tool configured to selectively bow out of the first window and to retract
within the first window; and a removable transducer core, the transducer core including an active transducer
element configured to face out of the second window when the removable transducer core is
fitted within the tubular member.
Claim 37
Dependent Claim
18 words
The device of claim 36, wherein the removable core is adapted to snap fit
within the tubular member.
Claim 38
Dependent Claim
14 words
The device of claim 36, wherein the active transducer element includes an
ultrasound transducer.
Claim 39
Dependent Claim
21 words
The device of claim 36, wherein the removable transducer core comprises a
tapered distal tip configured to readily penetrate soft tissue.
Claim 40
Dependent Claim
19 words
The device of claim 36, further comprising an external tissue collection device
attached at least to the cutting tool.
Claim 41
Dependent Claim
34 words
The device of claim 40, wherein the tubular member further comprises a
recessed section adjacent a trailing edge of the cutting tool, the recessed section being adapted
to receive the external tissue collection device.
Claim 42
Dependent Claim
25 words
The device of claim 36, further comprising an expandable sheath, the
expandable sheath being adapted to receive the removable transducer core and the tubular
member.
Claim 43
Dependent Claim
139 words
Method of excising a lesion from soft biological tissue using an excisional
biopsy system including a generally tubular member having a cutting tool, a removable
transducer core adapted to fit within the tubular member and an expandable sheath,
comprising the steps of: fitting the transducer core through the expandable sheath, inserting the transducer and sheath though an incision in the tissue; imaging a target site within the tissue by energizing the transducer core, removing the transducer core from sheath while leaving the sheath in place within the
tissue; securing the core within the generally tubular member so the core faces outwardly
from the tubular member; sliding the tubular member through the expandable sheath until the cutting tool is
positioned adjacent the lesion; cutting the lesion with the cutting tool; and retracting at least the tubular member from the incision.
Claim 44
Dependent Claim
28 words
The method of claim 43, further comprising the step of stabilizing the breast in
one of an uncompressed and a slightly expanded state prior to the inserting step.
Claim 45
Dependent Claim
45 words
The method of claim 43, wherein the sheath remains within the tissue after the
retracting step and wherein the method further comprises the step of: re-inserting the transducer core within the sheath and imaging the target site to insure
that the lesion has been excised.
Claim 46
Dependent Claim
25 words
The method of claim 43, further comprising the step of collecting the cut lesion
within an external tissue collection device secured to the tubular member.
Claim 47
Dependent Claim
18 words
The method of claim 43, wherein both the tubular member and the sheath are
retracted from the incision.
Claim 48
Dependent Claim
106 words
An excisional biopsy device, comprising: a single use disposable tubular member having a window near a distal tip thereof, the
tubular member including a cutting tool, a distal end of the cutting tool being attached near
the distal tip of the tubular member, at least a distal portion of the cutting tool being
configured to selectively bow out of the window and to retract within the window; and a single use disposable tissue collection device externally attached at least to the
tubular member, the tissue collection device collecting tissue severed by the cutting tool as the
biopsy device is rotated and the cutting tool is bowed.
Claim 49
Dependent Claim
78 words
An excisional biopsy device, comprising: a single use disposable tubular member having a first and a second window near a
distal tip thereof, the tubular member including a cutting tool configured to selectively bow
out of the first window and to retract within the first window; and a removable transducer core, the transducer core including an active transducer
element configured to face out of the second window when the removable transducer core is
fitted within the tubular member.
References Cited (Backward Citations)
No citation records indexed.
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