U.S. patent application number 09/895732 was filed with the patent office on 2001-11-29 for surgical device for the collection of soft tissue.
Invention is credited to Buzzard, Jon D., Hibner, John A., Iverson, David S., Piller, Michael E., Privitera, Salvatore, Reiter, Michael J..
Application Number | 20010047183 09/895732 |
Document ID | / |
Family ID | 24166661 |
Filed Date | 2001-11-29 |
United States Patent
Application |
20010047183 |
Kind Code |
A1 |
Privitera, Salvatore ; et
al. |
November 29, 2001 |
Surgical device for the collection of soft tissue
Abstract
A handheld biopsy device is provided for the collection of soft
tissue samples from a surgical patient. In a preferred embodiment,
the biopsy device comprises a handpiece, a fluid collection system,
and a power transmission source. The handpiece is configured for
grasping by a single hand, and being independently manipulatable by
hand for movement of the instrument toward and away from the
patient. An elongated piercer extends from the distal end of the
handpiece. The piercer has a sharpened distal end for entering the
tissue and a port located proximal to the sharpened distal end for
receiving a portion of tissue mass. An elongated cutter is disposed
coaxially relative to a piercer lumen of the piercer. A distal
blade of the cutter slides distally past the port of the piercer to
severe the tissue portion drawn into the port by vacuum. The cutter
is retracted to a most proximal position for removal of the tissue
portion from a cutter lumen of the cutter. The handpiece further
comprises a holster for detachably connecting a cutter rotational
transmission and a cutter axial transmission to the power
transmission source.
Inventors: |
Privitera, Salvatore; (West
Chester, OH) ; Hibner, John A.; (Mason, OH) ;
Buzzard, Jon D.; (Milford, OH) ; Piller, Michael
E.; (Cincinnati, OH) ; Iverson, David S.;
(Chicago, IL) ; Reiter, Michael J.; (Oak Park,
IL) |
Correspondence
Address: |
AUDLEY A. CIAMPORCERO JR.
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
24166661 |
Appl. No.: |
09/895732 |
Filed: |
June 29, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09895732 |
Jun 29, 2001 |
|
|
|
09543122 |
Apr 5, 2000 |
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Current U.S.
Class: |
606/170 |
Current CPC
Class: |
A61B 10/0275 20130101;
A61B 10/0283 20130101; A61B 2010/0208 20130101; A61B 10/0266
20130101; A61B 90/361 20160201 |
Class at
Publication: |
606/170 |
International
Class: |
A61B 017/32 |
Claims
What is claimed is:
1. A biopsy device for the collection and retrieval of at least one
soft tissue portion from a surgical patient, said biopsy device
comprising: a. a handpiece configured for grasping by a single
hand, said handpiece having a distal end and a proximal end, said
handpiece being independently manipulatable by the single hand
without an external support for movement of said biopsy device
toward and away from the surgical patient; b. an elongated piercer
extending from the distal end of said handpiece, said piercer
having i. a piercer lumen, ii. a sharpened distal end for entering
tissue when said handpiece of said biopsy device is moved
independently by the single hand toward the surgical patient so as
to cause said sharpened distal end to penetrate the tissue, and
iii. a port located proximal to said sharpened distal end for
receiving a portion of a tissue mass when said handpiece is further
manipulated independently by the single hand so as to position the
tissue mass adjacent to said port, said piercer lumen being in
fluid communication with said port; c. an elongated cutter having a
distal end, a proximal end, and a cutter lumen therethrough, said
cutter being disposed coaxially and slidably relative to said
piercer, said cutter having a cutting blade on the cutter distal
end for cutting the portion of tissue protruding into said port of
said piercer when said cutter slides distally past said port,
thereby depositing the portion of cut tissue within said cutter
lumen of said cutter proximal to said cutting blade; d. a cutter
rotational transmission contained within said handpiece and
operationally connected to said elongated cutter, and when said
cutter rotational transmission is actuated, said cutter is rotated
about its longitudinal axis; e. a cutter axial transmission
contained within said handpiece and operationally connected to said
elongated cutter, and when said cutter axial transmission is
actuated, said cutter is slid in an axial direction relative to
said piercer; and f. a power transmission source connected to the
proximal end of said handpiece and operationally engageable with:
i. said cutter rotational transmission for actuating said cutter
rotational transmission, and ii. said cutter axial transmission for
actuating said cutter axial transmission.
2. The biopsy device of claim 1 further comprising a tubular tissue
remover having a proximal end and a distal end, said remover
disposed in said cutter lumen of said cutter and having a strainer
on the distal end thereof and disposed proximally of said port,
said strainer for obstructing said cutter lumen so that the portion
of cut tissue severed by said cutter is prevented from moving
proximally through said cutter lumen.
3. The biopsy device of claim 2 further comprising a first vacuum
tube having a proximal end and a distal end, and the distal end of
said first vacuum tube is connected in fluid communication to the
proximal end of said tubular tissue remover.
4. The biopsy device of claim 3 further comprising a first
connector attached to the proximal end of said first vacuum tube,
said first connector providing for the fluidic connection of said
first vacuum tube to a fluid collection system.
5. The biopsy device of claim 3 wherein said first vacuum tube is
made of a material which permits visualization of the flow of fluid
therethrough.
6. The biopsy device of claim 1 further comprising a second vacuum
tube having a distal end and a proximal end, and a portion of said
second vacuum tube is contained within said handpiece, wherein the
proximal end of said second vacuum tube is releasably attached to a
fluid collection system, and the distal end of said second vacuum
tube is in fluid communication with said piercer lumen.
7. The biopsy device of claim 6 wherein said second vacuum tube is
made of a material which permits visualization of the flow of fluid
therethrough.
8. The biopsy device of claim 6 further comprising a second
connector attached to the proximal end of said second vacuum tube,
said second connector providing for the fluidic connection of said
second vacuum tube to said fluid collection system.
9. The biopsy device of claim 1 wherein said handpiece further
comprises a holster for detachably connecting said handpiece to
said power transmission source.
10. The biopsy device of claim 9 wherein said power transmission
source includes a first electrically driven motor and a first
rotatable shaft, and said first motor is connected to the proximal
end of said first rotatable shaft, and said first rotatable shaft
has a distal end rotationally mounted to said holster, so that said
first motor is operationally engaged with said cutter rotational
transmission of said handpiece.
11. The biopsy device of claim 10 wherein said power transmission
source further includes a second electrically driven motor and a
second rotatable shaft, and said second motor is connected to the
proximal end of said second rotatable shaft, and said second
rotatable shaft has a distal end rotationally mounted to said
holster, so that said second motor is operationally engaged with
said cutter axial transmission of said handpiece.
12. The biopsy device of claim 1 wherein said handle has a tissue
sampling surface thereon disposed between the proximal and distal
ends of said handpiece for the retrieval of the portion of the cut
tissue from within said cutter lumen of said biopsy device.
Description
RELATED PATENTS AND PATENT APPLICATIONS
[0001] This application is related to the following co-pending U.S.
patent application Ser. No. 08/825,899 filed on Apr. 2, 1997; Ser.
No. 09/107,845 filed on Jun. 30, 1998. This application is further
related to the following co-pending U.S. patent application Ser.
No. ______, filed (Attorney Docket No. END 562); Ser. No. ______,
filed (Attorney Docket No. END 563).
FIELD OF THE INVENTION
[0002] The present invention relates, in general, to devices for
tissue sampling and, more particularly, to improved biopsy probes
for acquiring subcutaneous biopsies and for removing lesions.
BACKGROUND OF THE INVENTION
[0003] The diagnosis and treatment of patients with cancerous
tumors, pre-malignant conditions, and other disorders has long been
an area of intense investigation. Non-invasive methods for
examining tissue include palpation, X-ray, MRI, CT, and ultrasound
imaging. When the physician suspects that a tissue may contain
cancerous cells, a biopsy may be done using either an open
procedure or a percutaneous procedure. For an open procedure, a
scalpel is used by the surgeon to create a large incision in the
tissue in order to provide direct viewing and access to the tissue
mass of interest. The entire mass (excisional biopsy) or a part of
the mass (incisional biopsy) may then be removed. For a
percutaneous biopsy, a needle-like instrument is used through a
very small incision to access the tissue mass of interest and to
obtain a tissue sample for later examination and analysis. The
advantages of the percutaneous method as compared to the open
method may be significant and may include: less recovery time for
the patient, less pain, less surgical time, lower cost, and less
disfigurement of the patient's anatomy. Use of the percutaneous
method in combination with imaging devices such as X-ray and
ultrasound has resulted in highly reliable diagnoses and
treatments.
[0004] Generally there are two ways to obtain percutaneously a
portion of tissue from within the body, by aspiration or by core
sampling. Aspiration of the tissue through a fine needle requires
the tissue to be fragmented into pieces small enough to be
withdrawn in a fluid medium. The method is less intrusive than
other known sampling techniques, but one can only examine cells in
the liquid (cytology) and not the cells and the structure
(pathology). In core biopsy, a core or fragment of tissue is
obtained for histologic examination which may be done via a frozen
or paraffin section.
[0005] The type of biopsy used depends mainly on various factors
present in the patient, and no single procedure is ideal for all
cases. Core biopsy, however, is very useful in a number of
conditions and is widely used by physicians.
[0006] A number of biopsy devices have been designed and
commercialized for use in combination with imaging devices. One
such biopsy instrument is the BIOPTY gun, available from C. R.
Bard, Inc. and described in U.S. Pat. Nos. 4,699,154 and 4,944,308
as well as in U.S. Reissued Pat. No. Re. 34,056. The BIOPTY gun is
a core sampling biopsy device in which the biopsy needle is
spring-powered. However, when using the BIOPTY gun, the breast or
organ must be punctured and the device is re-inserted each time a
sample is taken. Another core biopsy device is the TRUE CUT needle
manufactured by Travenol Laboratories. This TRUECUT needle collects
a single core of tissue using a pointed element with a side-facing
notch to receive tissue and an outer, sharpened sliding cannula to
cut the core sample from the surrounding tissue.
[0007] Aspiration biopsy devices for obtaining biopsy samples from
the body are described in the following: U.S. Pat. No. 5,492,130;
U.S. Pat. No. 5,526,821; U.S. Pat. No. 5,429,138; and U.S. Pat. No.
5,027,827. These patents describe devices which use the aspiration
method of liquid suspended tissue extraction rather than core
sampling to extract tissue.
[0008] To overcome operator error associated with such devices, and
to enable multiple sampling of the tissue without having to reenter
the tissue for each sample, a biopsy instrument now marketed under
the tradename MAMMOTOME was developed. Embodiments of the
invention-are described in U.S. Pat. No. 5,526,822. The MAMMOTOME
instrument is a type of image-guided, percutaneous, coring, breast
biopsy instrument. It is vacuum-assisted and some of the steps for
retrieving the tissue samples have been automated. The physician
uses this device to capture "actively" (using the vacuum) the
tissue prior to severing it from the body. This allows for sampling
tissues of varying hardness. In the MAMMOTOME biopsy instrument,
the cutter is rotated using a motor drive mounted in the instrument
while the surgeon manually moves the cutter back and forth by a
knob on the outside of the instrument. Thus, the surgeon is able,
through tactile feedback, to determine whether the blade is
effectively cutting tissue or if there is a problem, such as
binding or stalling. The surgeon may then adjust the speed at which
the blade is moved through the tissue, stop the blade, or back the
blade away from the tissue. The device can also be used to collect
multiple samples in numerous positions about its longitudinal axis,
without removing the biopsy needle from the body. These features
allow for substantial sampling of large lesions and complete
removal of small ones. In the MAMMOTOME, a vacuum chamber is
attached alongside and fluidly connected to an elongated, hollow
piercer. The vacuum supplied through the vacuum chamber pulls
tissue into the lateral receiving port of the hollow piercer.
[0009] For breast biopsies, the devices described so far are most
commonly used in combination with either X-ray or ultrasound
imaging to locate suspicious tissue, although other imaging
modalities such as magnetic resonance imaging are also available.
When using, for example, the MAMMOTOME biopsy device with an X-ray
stereotactic table, the biopsy device is attached to a movable,
mechanical mounting arm. The patient lies face down on the table
and the patient's breast is guided through an opening in the
stereotactic table. Several X-ray images of the breast are taken
from different angles to determine the location of the
calcifications, lesions, etc. which are to be removed from the
breast. Next the mounting arm is manually repositioned so that the
biopsy device is properly aligned with the breast. Then the
mounting arm is manipulated to push piercer of the biopsy device
into the breast until the tip of the piercer is positioned
alongside the tissue to be sampled. Additional X-ray images are
then made to confirm that the port on the distal end of the piercer
is in the proper position to collect the desired tissue portions.
The biopsy device is then used to retrieve one or more core samples
of tissue. Additional X-ray images are taken to confirm the removal
of the suspect tissue. Sometimes the biopsy device and mounting arm
must be repositioned during the procedure so that the tip of the
piercing element is in a new location in order to retrieve more
tissue samples. As this brief description illustrates, there are
many time consuming steps in getting the biopsy device properly
positioned to retrieve the desired tissue. In addition, the
accessibility of certain parts of the breast may be hindered by the
degrees of freedom of the movement of the mounting arm. Also, the
size of the stereotactic table and associated equipment precludes
portability of the system. It is not possible, for example, to have
a number of patients being prepared for the procedure in separate
rooms of a clinic, if there is only one room set-up for doing the
procedure. Having a portable system would allow the surgeon to go
from room-to-room and perform the procedure, and thus allow more
patients to be treated in a given time period at the clinic.
[0010] Biopsy devices are also used with other kinds of X-ray
imaging systems such as those for which the patient is upright
rather than lying down. The numerous steps described above for
locating, confirming, and reconfirming using X-ray stereo
"snapshots" are also necessary for the upright versions.
[0011] The MAMMOTOME biopsy instrument may also be used with real
time handheld imaging devices such as ultrasound imaging devices.
When using a biopsy instrument such as the MAMMOTOME with a
handheld ultrasound imaging device, the surgeon gains the advantage
of having real time imaging of the tissue of interest. Typically
the ultrasound imaging device is held in one hand and pointed at
the tissue being penetrated by the piercer. In order to facilitate
positioning and manipulation of both the biopsy instrument and the
imaging device, it is normally necessary to attach the biopsy
instrument to a mechanical, articulating arm which is designed to
support the weight of the biopsy instrument. In addition, since
axial movement of the cutter on the MAMMOTOME is actuated by hand,
the biopsy device must be rigidly supported to allow the surgeon to
actuate the cutter without moving the tip. Alternatively, an
assistant may be used to help operate the controls for the biopsy
device. It would, therefore, be advantageous to design a handheld
core sampling biopsy instrument wherein the cutter of the
instrument was moved using a motor drive which could be actuated by
the touch of a switch. Further, since some of the electrical and
vacuum controls are not on the MAMMOTOME biopsy instrument itself,
the biopsy instrument must be rigidly supported or the surgeon must
have an assistant to actuate the controls. It would, therefore, be
further advantageous if the electrical and vacuum controls for the
biopsy device were positioned in relatively close proximity either
on the instrument or, for example, on an associated generator.
Automating axial movement of the cutter will, to some extent,
eliminate the tactile feedback that the surgeon gets from moving
the cutter blade manually. It would, therefore, be advantageous to
provide a method of automatically measuring and controlling the
axial movement of the cutter which could be utilized to, for
example, prevent the cutter from advancing when the port is
blocked.
[0012] In recent years several patents have issued describing
handheld, motorized devices for the extraction of tissue from the
body. Many of these devices are for arthroscopic surgery and are
not intended for retrieving biopsy core samples of tissue for
pathological analysis. The motors are for rotationally driving the
cutting/milling end effectors, but not for advancing the end
effectors into the tissue. Examples of arthroscopic, handheld,
motorized devices include the following U.S. Pat. Nos.: 4,995,877;
4,705,038; 5,192,292; 5,112,299; 5,437,630; 5,690,660; and
5,320,635.
[0013] In U.S. Pat. No. 4,940,061 issued to Terwilliger, et al, on
Jul. 10, 1990, a core sampling, handheld biopsy device
incorporating a battery powered motor for driving a means to
penetrate and sever tissue is described. The motor axially drives a
cutter to advance the cutter into tissue, thus eliminating the
noise and jerking associated with mechanical stops of the
spring-actuated devices. This significantly adds to the comfort of
both the patient and the surgeon. However, the device does not
incorporate a vacuum source for obtaining the tissue portion. As
described in Burbank, et al, '822 and '333, the vacuum greatly
facilitates the capturing of a complete tissue portion within the
distal end port on the piercing element. Capturing more tissue with
each sample reduces the number of samples required, and increases
the likelihood of obtaining the diseased tissue. The Terwilliger
device in '061 also does not address how to minimize leakage and
spilling of the high volume of fluids present in biopsy
procedures.
[0014] The surgeon may prefer to use an X-ray imaging system for
some patients, and an ultrasound imager for others. In such
situations, it would be desirable to use a biopsy instrument which
is adaptable to both kinds of imaging systems. Such an instrument
could be used as a handheld instrument or also as an instrument
mounted onto the arm of an X-ray stereotactic table, depending on
the situation.
[0015] It is therefore desirable to provide a more versatile and
"patient friendly" biopsy device than what is currently available.
The device should be particularly adapted for use without mounting
to an X-ray stereotactic table. It should be a lightweight,
maneuverable, handheld device, so that the surgeon may have the
option to perform the biopsy procedure in combination with an
ultrasound imaging device. It is desirable that the device be
easily transported from room-to-room so that several patients may
be prepared for the surgical procedure concurrently, thus allowing
more patients to be treated in a given time period, and potentially
reducing the overall cost of the surgical procedure. In addition,
it is desirable to perform a biopsy with fewer steps in order to
decrease the overall time of the procedure. This would be
achievable by eliminating the need to set-up and operate the X-ray
stereotactic table. The combination of these factors could allow
the surgical procedure to be more widely available to patients than
it is currently.
[0016] It is also desirable to provide a handheld biopsy device
which may be held parallel to the chest wall of the patient, so
that suspect tissue masses close to the chest wall can be easily
sampled. It is desirable that the surgeon be able to easily steer
the penetrating tip of the handheld device towards the desired
tissue to be sampled. It is further desired that the
surgeon-have-tactile-feedback as the tissue is probed by the
penetrating tip of the device, to provide the surgeon with clues
regarding the disease state of the tissue encountered. It is also
desirable that the biopsy device be "patient friendly" by not
having noisy or jerky mechanical actuations during the procedure,
and by not having to be used with large machines such as an X-ray
stereotactic table.
SUMMARY OF THE INVENTION
[0017] The present invention overcomes problems associated with
using a biopsy instrument which may be used only when mounted to an
X-ray stereotactic system. In the preferred embodiment, the present
invention is a handheld biopsy device which may be used in
combination with another handheld imaging device such as an
ultrasound imaging device. The biopsy instrument is for the
collection of at least one soft tissue sample from a surgical
patient. The biopsy instrument has a handpiece which is
independently manipulatable by hand movement of the instrument
toward and away from the patient. The biopsy instrument has an
elongated piercer extending from the distal end of the handpiece.
The piercer has a piercer lumen through it and a sharpened distal
end for entering tissue when the handpiece is moved independently
by hand toward the surgical patient so as to cause the sharpened
distal end to penetrate tissue. The piercer also has a port located
proximal to the sharpened distal end for receiving a portion of a
tissue mass when the handpiece is further manipulated independently
by hand so as to position the tissue mass adjacent to the port. The
piercer lumen is in fluid communication with this port.
[0018] The present invention also has an elongated cutter with a
lumen through it. This cutter is disposed coaxially and slidably
relative to the piercer. The cutter has a cutting blade on the
distal end for cutting the portion of tissue protruding into the
port of the piercer when the cutter slides distally past the port.
A portion of the cut tissue is then deposited within the cutter
lumen proximal to the cutting blade.
[0019] The present invention includes a cutter rotational
transmission contained within the handpiece and operationally
connected to the elongated cutter. When the cutter rotational
transmission is actuated, the cutter is rotated about its
longitudinal axis.
[0020] The present invention further includes a cutter axial
transmission contained within the handpiece and operationally
connected to the elongated cutter. When the cutter axial
transmission is actuated, the cutter is slid in an axial direction
relative to the piercer. It is slid in the distal axial direction
to cut a portion of tissue protruding into the port. It is slid in
the proximal axial direction to retrieve the cut portion of tissue
from the biopsy instrument.
[0021] The biopsy device also has a power transmission source which
is operationally engageable with the cutter rotational transmission
for rotation of the cutter. In the preferred embodiment, the power
transmission source is also operationally engageable with the
cutter axial transmission for the longitudinal movement of the
cutter. A first electric motor is operationally engaged to the
cutter rotational transmission by a first flexible, rotatable
shaft. A second electric motor is operationally engaged to the
cutter axial transmission by a second flexible, rotatable shaft.
The handpiece also includes a holster. The distal ends of the first
and second rotatable shafts are rotatably mounted in the holster so
that the first and second shafts are operationally engaged,
respectively, to the cutter rotational transmission and the cutter
axial transmission inside the handpiece.
[0022] In the preferred embodiment of the present invention, a
tubular tissue remover is disposed in the cutter lumen of the
cutter. The tissue remover pushes the tissue portion out of the
distal end of the cutter lumen and onto a tissue sapling surface of
the handle when the cutter is retracted in the proximal direction.
The proximal end of the tissue remover is connected to a first
vacuum tube which is connected by a first connector to a fluid
collection system. The fluidic contents of the cutter lumen are
transported to the fluid collection system when the vacuum is
actuated. A strainer on the distal end of the remover is provided
to block the tissue portion from entering the remover.
[0023] Also in the preferred embodiment, the proximal end of the
piercer lumen is connected by a second vacuum tube which is
connected by a second connector to the fluid collection system. The
fluidic contents of the piercer lumen also are transported to the
fluid collection system when the vacuum of the system is
actuated.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The novel features of the invention are set forth with
particularity in the appended claims. The invention itself,
however, both as to organization and methods of operation, together
with further objects and advantages thereof, may best be understood
by reference to the following description, taken in conjunction
with the accompanying drawings in which:
[0025] FIG. 1 is an isometric view of the present invention, a
biopsy instrument which includes a handpiece for the collection of
soft tissue;
[0026] FIG. 2 is an isometric view of the handpiece showing a probe
assembly prior to attachment to a holster;
[0027] FIG. 3 is an exploded isometric view of the probe
assembly;
[0028] FIG. 4 is an isometric view of the probe assembly of FIG. 2
with the left handle shell removed to reveal the internal
components;
[0029] FIG. 5 is an exploded isometric view of the holster;
[0030] FIG. 6A is a top view in section of the probe assembly and a
distal portion of the holster, revealing a cutter in the a first,
fully retracted position;
[0031] FIG. 6B is a top view in partial section of the distal end
of the probe assembly for when the cutter is in the first position
and a port on the distal end of a piercer is open;
[0032] FIG. 7A is a top view in section of the probe assembly and a
distal portion of the holster, revealing the cutter in a third,
intermediate position;
[0033] FIG. 7B is a top view in partial section of the distal end
of the probe assembly and the port on the distal end of the piercer
is open in order to receive the tissue portion to be removed from
the patient, and a distal blade (shown with hidden lines) of the
cutter is immediately proximal to the port, corresponding to the
third position of the cutter shown in FIG. 7A;
[0034] FIG. 8A is a top view in section of the probe assembly and a
distal portion of the holster revealing the cutter in a fourth,
fully deployed position;
[0035] FIG. 8B is a top view in partial section of the distal end
of the probe assembly and the distal blade (shown with hidden
lines) of the cutter is shown distal to the port on the distal end
of the piercer, corresponding with the fourth position of the
cutter tube shown in FIG. 8A;
[0036] FIG. 9 is an isometric view of the probe assembly with the
left handle shell removed, showing the cutter in the first
position, and a tissue portion is shown deposited onto a tissue
sampling surface of the handle after the tissue portion was removed
from the distal end of the cutter;
[0037] FIG. 10 is a partial top view of a second embodiment of the
present invention, wherein a holster upper shell and a probe
assembly upper shell have been removed to reveal the internal
components;
[0038] FIG. 11 is an isometric view of a holster lower shell and
part of a probe assembly lower shell of the biopsy instrument shown
in FIG. 10 revealing a latch and a holster slot;
[0039] FIG. 12 is a longitudinal section of the assembled
components of FIG. 11;
[0040] FIG. 13 is an exploded isometric view of a holster of a
third embodiment of the present invention, showing a switch board
and a rotation sensor;
[0041] FIG. 14 is a schematic diagram of a control unit and its
relationship to the other components of the present invention;
and
[0042] FIG. 15 is an enlarged diagram of the display illustrated in
FIG. 14.
DETAILED DESCRIPTION OF THE INVENTION
[0043] FIG. 1 shows a first embodiment of biopsy instrument
comprising a probe assembly 40, a holster 140, a fluid collection
system 22, a control unit 342, and a power transmission source 24.
The probe assembly 40 is detachably connected to the holster 140.
Together they constitute a lightweight, ergonomically shaped, hand
manipulatable portion referred to as a handpiece 20. The probe
assembly 40 includes a piercer 70 extending distally from a hollow
handle 43. The probe assembly 40 is fluidly connected to the fluid
collection system 22 by a first vacuum tube 94 and a second vacuum
tube 136. The first and second vacuum tubes are detachably
connected to the fluid collection system 22 by a first connector 27
and a second connector 25, respectively. The first connector has a
male portion 32 and a female portion 28 attached to the first
vacuum tube 94. The second connector 25 has a female portion 30 and
a male portion 26 attached to the second vacuum tube 136. The
connector portions, 26, 28, 30, and 32, are attached in this manner
to prevent the accidental switching of the first and second tubes,
136 and 94, to the fluid collection system 22. The holster 140
includes a first rotatable shaft 34, a second rotatable shaft 36,
and a control cord 38. The first and second rotatable shafts, 34
and 36, are preferably flexible so that the operator may easily
manipulate the handpiece 20 with one hand. The control cord 38
operatively connects the handpiece 20 to the power transmission
source 24 and control unit 342.
[0044] Since the handpiece 20 is manipulated by the operator's hand
rather than by an electro-mechanical arm, the operator may steer
the tip of the handpiece 20 with great freedom towards the tissue
mass of interest. The surgeon has tactile feedback while doing so
and can thus ascertain, to a significant degree, the density and
hardness of the tissue being encountered. In addition, the
handpiece 20 may be held approximately parallel to the chest wall
of the patient for obtaining tissue portions closer to the chest
wall then may be obtained when using a instrument mounted to an
electro-mechanical arm. As can be seen in FIG. 1, the piercer 70
extends from the distal end of the handpiece 40 and is
longitudinally offset with respect to the handpiece 40. This offset
also facilitates the insertion of the piercer 70 into the tissue
while the axis of the piercer 70 is approximately parallel to the
plane of the patient's chest wall. As a result, it is possible to
extract tissue potions which are located close to the chest wall of
the patient.
[0045] Those skilled in the art may appreciate that a mount or
"nest" could be provided to hold the handpiece 20 securely to the
movable arm of an X-ray stereotactic table or other kind of imaging
device which incorporates a movable arm for holding a biopsy
instrument. This would provide the operator with the option to use
the handpiece 20 to access the tissue mass within the surgical
patient in much the same manner as was described earlier for using
the MAMMOTOME instrument. This versatility may be advantageous to
the operator, for example, in a situation where the handheld
imaging device was temporarily not available for use, and it would
be necessary to use the X-ray stereotactic table.
[0046] FIG. 2 shows the holster 140 and the probe assembly 40
separated. A pair of tabs 144 project laterally from each side of a
holster upper shell 142, and insert into right and left undercut
ledges, 138 and 139 respectively, of the hollow handle 43 of the
probe assembly 40. A plurality of indentations 66 are provided on
the handle 43 to improve the operator's grip on the instrument. A
tube slot 162 in the lower shell 156 of the holster 140 provides
clearance for first and second vacuum tubes, 94 and 136. A first
switch 146, a second switch 148, and a third switch 150 are mounted
in the distal portion of the holster 140 so that the physician can
operate the handpiece 20 with a single hand while having the other
hand free to operate an ultrasonic imaging device or the like. The
switches 146, 148, and 150 are provided to operate the power
transmission source 24 and the fluid collection system 22 in
conjunction with the control unit 342. A ridge 152 on the distal
end of the holster 140 is provided to assist the operator in
grasping the handpiece 20 and in operating the switches 146, 148,
and 150. The ridge 152 further provides the operator with a tactile
reference as to where to properly grasp the handpiece 20.
[0047] Still in FIG. 2, the probe assembly 40 includes a window 58
so that a portion of the first vacuum tube 94 may be viewed. The
first and second vacuum tubes, 94 and 136, are made from a
flexible, transparent or translucent material, such as silicone
tubing. This enables visualization of the material flowing through
the tubes. By having the window 58 in the probe assembly 40, the
operator can see the flow in the first vacuum tube 94 without
needing to look away from the tissue into which the piercer 70 is
inserted. A transverse opening 68 is provided in the distal end of
the hollow handle 43 which allows access from either side to a
tissue sampling surface 64. The tissue extracted from the surgical
patient is retrieved by the operator or an assistant from the
tissue sampling surface 64.
[0048] FIG. 3 is an exploded isometric view of the probe assembly
40. The handle 43 is formed from a right handle shell 42 and a left
handle shell 44, each injection molded from a rigid, biocompatible
plastic such as polycarbonate. Upon final assembly of the probe
assembly 40, the left and right handle shells are joined together
by ultrasonic welding along a joining edge 62, or joined by any of
several other methods well known in the art. The probe assembly 40
comprises the piercer 70 which includes an elongated, metallic
piercer tube 74 having a piercer lumen 80. On the side of the
distal end of the piercer tube is a port 78 for receiving the
tissue to be extracted from the surgical patient. Joined alongside
the piercer tube 74 is an elongated, tubular, metallic vacuum
chamber tube 76 having a vacuum lumen 82. Piercer lumen 80 is in
fluid communication with vacuum lumen 82 via a plurality of vacuum
holes 77 (see FIG. 6B) located in the bottom of the "bowl" defined
by the port 78. These holes are small enough to remove the fluids
but not large enough to allow excised tissue portions to be removed
through the first vacuum tube 94 which is fluidly connected to the
vacuum chamber 76. A sharpened, metallic distal end 72 is attached
to the distal end of the piercer 70. It is designed to penetrate
soft tissue such as the breast. In this embodiment, the sharpened
distal end 72 is a three-sided, pyramidal-shaped point, although
the tip configuration may also have other shapes.
[0049] Still referring to FIG. 3, the proximal end of the piercer
70 is attached to a union sleeve 90 having a longitudinal bore 84
through it, a widened center portion 86, and a transverse opening
88 through the widened center portion 86. The union sleeve 90 is
mounted between the left and right handle shells, 44 and 42
respectively, on a pair of union sleeve ribs 50 projecting from
each handle shell. An elongated, metallic, tubular cutter 96 is
axially aligned within the longitudinal bore 84 of the union sleeve
90 and the piercer lumen 80 of the piercer 70 so that the cutter 96
may slide easily in both the distal and proximal directions. A pair
of cutter guides 46 are integrally molded into each of the handle
halves, 42 and 44, to slidably retain the cutter 96 in an coaxially
aligned position with the proximal end of the piercer tube 74.
Cutter 96 has a cutter lumen 95 through the entire length of the
cutter 96. The distal end of the cutter 96 is sharpened to form a
cutter blade 97 for cutting tissue held against the cutter blade 97
as the cutter 96 is rotated. The proximal end of the cutter 96 is
attached to the inside of a cutter gear bore 102 of a cutter gear
98. The cutter gear 98 may be metallic or polymeric, and has a
plurality of cutter gear teeth 100, each tooth having a typical
spur gear tooth configuration as is well known in the art.
[0050] Still in FIG. 3, the cutter gear 98 is driven by an
elongated drive gear 104 having a plurality of drive gear teeth 106
designed to mesh with the cutter gear teeth 100. The function of
the drive gear 104 is to rotate the cutter gear 98 and the cutter
96 as they translate in both longitudinal directions. The drive
gear 104 is preferably made from a metal such as stainless steel. A
distal drive axle 108 projects from the distal end of the drive
gear 104 and mounts into an axle support rib molded on the inside
of the left handle shell 44. A gear shaft 110 projects from the
proximal end of the drive gear 104 and is supported by a gear shaft
support rib also molded on the inside of the left handle shell 44.
A left cross pin 112 is attached to the proximal end of the gear
shaft 110 as a means for rotationally engaging the drive gear
104.
[0051] Still referring to FIG. 3, a carriage 124 is provided to
hold the cutter gear 98 and to carry the cutter gear 98 as it is
rotated in the distal and proximal directions. The carriage 124 is
preferably molded from a rigid polymer and is cylindrically shaped
with a threaded bore 126 through it and with a carriage foot 130
extending from its side. The foot 130 has a recess 128 formed into
it for rotatably holding the cutter gear 98 in the proper
orientation for the cutter gear teeth 100 to mesh properly with the
drive gear teeth 106. The carriage 124 is attached via the threaded
bore 126 to an elongated screw 114 which is parallel to the drive
gear 104. The screw 114 has a plurality of conventional lead screw
threads 116 and is preferably made from a stainless steel. The
rotation of the screw 114 in one direction causes the carriage 124
to move distally, while the reverse rotation of the screw 114
causes the carriage 124 to move proximally. In turn, the cutter
gear 98 moves distally and proximally according to the direction of
the screw rotation, and the cutter 96 is advanced or retracted. In
this embodiment, the screw 114 is shown with a right hand thread so
that clockwise rotation (looking from the proximal to distal
direction) causes the carriage 124 to translate in the distal
direction. It is also possible to use a left-hand thread for the
screw 114 as long as provisions are made to do so in the control
unit 342. A distal screw axle 118 and a proximal screw shaft 120
project from the distal and proximal ends, respectively, of the
screw 114. The distal screw axle mounts rotatably in a distal screw
support 48 of the right handle shell 42 while the proximal screw
shaft 120 mounts rotatably in a proximal screw support 54, also in
the right handle shell 42. A right cross pin 122 is attached to the
proximal end of the screw shaft 120 as a rotational engagement
means.
[0052] FIG. 3 also shows the first and second vacuum tubes, 94 and
136 respectively, referred to earlier. The distal end of the first
vacuum tube 94 is attached to a polymeric vacuum fitting 92 which
inserts tightly into the transverse opening 88 of the union sleeve
90. This allows the communication of fluids in the piercer lumen 80
to the fluid collection system 22. The first vacuum tube 94 is
contained within the hollow handle 43 in an open space above the
screw 114 and drive gear 104, and exits the distal end of the
hollow handle through an opening 57. The second vacuum tube 136 is
fluidly attached to the proximal end of an elongated, metallic,
tubular tissue remover 132. The second vacuum tube 136 exits the
hollow handle 43 alongside the first vacuum tube 94 out the opening
57. A strainer 134 is attached to the distal end of the tissue
remover 132 to prevent the passage of fragmented tissue portions
through it and into the fluid collection system 22. The tissue
remover 132 inserts slideably into the tubular cutter 96. During
operation of the biopsy instrument, the tissue remover 132 is
always stationary and is mounted between a pair of proximal
supports 52 on the inside of the right and left handle shells, 42
and 44 respectively. When the cutter 96 is fully retracted to the
first position, the distal end of the tissue remover 132 is
approximately even with the distal end of the cutter 96. The distal
end of the cutter 96 when at its first, fully retracted position,
is slightly distal to a vertical wall 69 which is proximal and
perpendicular to the tissue sampling surface 64.
[0053] In FIG. 3, a right access hole 56 is shown in the proximal
end of the right handle shell 43. The right access hole 56 provides
access to the proximal end of the screw 114 for operational
engagement to the power transmission source 24. Similarly, a left
access hole is provided in the left handle shell 44 to provide
access to the proximal end of the drive gear 104 for operational
engagement with the power transmission source 24.
[0054] The tissue remover 132 has two functions. First, it helps to
evacuate fluids contained in the piercer lumen 80. This is
accomplished by the attachment of the second vacuum tube 136 to the
proximal end of the tissue remover 132. Since the distal end of the
tissue remover 132 is inserted into the piercer lumen 80, the
piercer lumen 80 is fluidly connected to the fluid collection
system 22. Second, the tissue remover 132 removes tissue from the
cutter 96 as follows. When a tissue sample is taken, the cutter 96
advances to the fourth position just distal to the port 78, and a
severed tissue portion 200 is captured within the cutter lumen 95
in the distal end of the cutter 96. Then the cutter 96 translates
to the first position so that the cutter blade 97 is just distal to
the tissue sampling surface 64. At this position of the cutter 96,
the distal end of the tissue remover 132 (which is always
stationary) is approximately even with the distal end of the cutter
96. Therefore, any tissue portion of significant size contained
within the cutter lumen 95 is pushed out of the cutter lumen 95 and
onto the tissue sampling surface 64, as is shown in FIG. 9. The
tissue portion 200 may then be retrieved by the operator or an
assistant.
[0055] Now turning to FIG. 4, an isometric view of the probe
assembly 40 with the left handle shell 44 removed reveals the
placement of the components described for FIG. 3. Part of the first
vacuum tube 94 has also been removed for clarity. The carriage 124
is shown in the fully retracted position so that the cutter 96 is
also at the fully retracted, or first position. The cutter blade 97
is slightly distal to the vertical wall 69 on the handle 43. The
foot 130 of the carriage 124 is adapted to slide along a carriage
guide surface 60 on the inside bottom of the hollow handle 43.
[0056] As shown in FIG. 4, a cutter axial transmission 121 includes
the carriage 124, the screw 114, and the screw shaft 120. A cutter
rotational transmission 109 includes the drive gear 104, the cutter
gear 98, and the gear shaft 110.
[0057] FIG. 5 is an exploded isometric view of the holster 140 of
the first embodiment of the present invention. A holster upper
shell 142 and a holster lower shell 156 are each injection molded
from a rigid, biocompatible plastic such as polycarbonate. Upon
final assembly, the shells are joined together by screws (not
shown) or other types of fasteners well known in the art, into a
plurality of alignment holes 164. A gear drive shaft 180 and a
screw drive shaft 182 are contained within the proximal, enclosed
portion of the holster 140. These shafts extend from a grommet 176
which has a groove 172 for retainably mounting onto shell edge 170
of both holster upper and lower shells, 142 and 156, respectively.
The grommet 176 rotatably attaches the first rotatable shaft 34 to
the screw drive shaft 182 and the second rotatable shaft 36 to the
gear drive shaft 180. The first rotatable shaft 34 rotatably
inserts into a left bore 172 of the grommet 176. The second
rotatable shaft 36 rotatably inserts into a right bore 178. The
grommet 176 also provides a strain relieved attachment of the
control cord 38 to the holster 140.
[0058] Still referring to FIG. 5, the gear drive shaft 180 is
supported rotatably upon a pair of gear drive mounts 160 formed
into a first wall 166 and a second wall 168 of the inside of the
holster shells, 142 and 156. The screw drive shaft 182 is likewise
supported rotatably on screw drive mounts 158. A left coupler 184
is attached to the distal end of the drive gear shaft 180 and has a
left coupler mouth 192 for rotational engagement with the left
cross pin 112 attached to the gear shaft 110. When the probe
assembly 40 shown in FIG. 4 is attached to the holster 140, the
gear shaft 110 becomes rotatably engaged to the gear drive shaft
180. This may be seen more clearly in FIG. 6A. Similarly, the screw
drive shaft 182 has a right coupler 186 with a mouth 194 which
rotatably engages with the cross pin 122 of the screw shaft 120.
Each of the left and right couplers, 184 and 186, have a coupler
flange, 188 and 190, which rotatably insert into thrust slots 159
formed into the corresponding portions of the drive mounts 158 and
160. These coupler flanges, 188 and 190, bear the axial loading of
the drive shafts, 180 and 182.
[0059] Still referring to FIG. 5, the holster 140 further includes
a screw rotation sensor 198, available from Hewlett Packard as part
number HEDR-81002P, for providing an electronic signal to the
control unit 342 to be described in more detail later. In this
first embodiment, the rotation sensor 198 is mounted within the
inside of the holster upper shell 142 and in a position directly
above the screw drive shaft 182. A fluted wheel 199 is attached to
the screw drive shaft 182 and extends in front of a light emitting
diode contained within the rotation sensor 198. As the fluted wheel
192 rotates, the interrupted light beams are electronically
detected and transmitted back to the control unit 342 to provide
information about the rotational speed of the screw drive shaft
(cutter tube axial advancement or retraction speed), and the number
of screw rotations from the beginning of operation (instantaneous
axial position of the cutter 96). The rotation sensor leads 196
pass through the grommet 176 and are part of the bundle of
conductors within the control cord 38.
[0060] The holster 140 of the first embodiment of the present
invention has the switches, 146, 148, and 150, mounted on the
inside of the holster upper shell 142. The switches, 146, 148, and
150, are electronically connected to a plurality of conductors 193
contained in the control cord 38. In one embodiment, the third
switch 150 operates the fluid communication between the handpiece
20 and the fluid collection system 22 and also sets the control
unit 342 to respond to various commands; the second switch 148
operates the movement of the cutter 96 in the proximal direction
and sets the control unit 342 to respond to various commands; the
firstswitch 146 operates the movement of the cutter 96 in the
distal direction and sets the control unit 342 to respond to
various commands. The functions of the switches, 146, 148, and 150,
are not restricted to what has been described for the first
embodiment. Also, the physical locations of the switches, 146, 148,
and 150, on the handpiece 20 are not restricted to the locations
depicted in FIG. 2. Other embodiments of the handpiece 20 of the
present invention may incorporate certain ergonomic or other
considerations, and the switches, 146, 148, and 150, may be located
elsewhere.
[0061] FIGS. 6A through 8A depict three of the four positions of
the cutter 96 during the operation of the present invention as
embodied in the prior FIGS. 1-5. The three positions are most
easily distinguished by observing the relative positions of the
carriage 124 and the cutter blade 97 of the cutter 96.
[0062] In FIGS. 6A and 6B, the retracted, first position is
depicted with the carriage 124 located on the proximal ends of the
drive gear 104 and the screw 114. The cutter blade 97 is shown to
be immediately proximal to the tissue sampling surface 64. In this
first position, the tissue portion 200 may be retrieved from the
tissue sampling surface 64 as depicted in FIG. 9.
[0063] The second position of the cutter 96 is not shown in the
Figures. At the second cutter position, the distal end of the
cutter 96 is just distal to the tissue sampling surface 64 and
inside the piercer lumen 80 near the proximal end of the piercer
tube 74. During operation the cutter 96 is moved from the first
position to the second position at a slower axial speed than from
the second position to the third position in order to facilitate
the insertion of the cutter 96 into the proximal end of the piercer
lumen 80.
[0064] In FIGS. 7A and 7B, the cutter 96 is shown in the third
position. The carriage 124 is shown to have moved axially to the
intermediate position which is a short distance from the distal
ends of the screw 114 and the drive gear 104. The cutter blade 97
is shown by hidden lines to be located just proximal to the port
78. The vacuum holes 77 are open to the port 78 so that soft tissue
adjacent to the port 78 prolapses into the port 78 when the first
vacuum tube 94 is fluidly connected to the vacuum of the fluid
collection system 22.
[0065] FIGS. 8A and 8B shows the cutter 96 at the fourth position,
and the carriage 124 is located near the distal ends of the screw
114 and the drive gear 104. The cutter blade 97 is shown now (by
hidden lines) to be distal to the port 78 and to be covering the
vacuum holes 77. The tissue pulled into the port 78 will have been
severed by the rotating, advancing cutter blade 97 and stored
inside the cutter lumen 95 of the distal end of the cutter 96. When
the cutter 96 retracts back to the first position as shown in FIGS.
6A and 6B, the tissue portion 200 may be retrieved as shown in FIG.
9.
[0066] FIG. 10 shows a second embodiment of the present invention.
The main difference from the first embodiment is that in the second
embodiment a first and a second brushless, electric motor, 234 and
236 respectively, are mounted inside a holster 221. First and
second motors, 234 and 236, are available from Harowe Servo
Controllers, Inc., part number B0508-050. In this second
embodiment, the rotatable shafts 34 and 36 have been eliminated so
that only a control/electrical power cord 232 is required to
electrically connect the holster 221 to the power transmission
source 24 and the control unit 342 (see FIG. 1). A holster lower
shell 222 has a first wall 242 and a second wall, 244, which are
spaced apart and adapted to support the pair of electric motors,
234 and 236 in a side-by-side arrangement. The use of the brushless
electric motors, 234 and 236, eliminates the need for a separate
rotation sensor to be mounted in the drive train of one or both of
a screw 206 and a drive gear 204 as was described for the first
holster embodiment shown in FIG. 5. As in the first embodiment,
when a probe assembly 202 is attached to the bolster 221, a right
coupler 238 rotationally engages a right cross pin 214 of a screw
shaft 210. A left coupler 240 rotationally engages a left cross pin
216 of a gear shaft 212. A grommet 230 having a grommet groove 231
is retained by an attachment slot 233 in the holster shell 222.
Fastener holes 228 are provided to fasten the holster lower shell
222 to a holster upper shell using screws or other types of
fasteners well known in the art.
[0067] Still referring to FIG. 10, another difference of the second
embodiment compared to the first is that the probe assembly 202
comprises a lower shell 208 and an upper shell (removed for
clarity) whereas the hollow handle 43 of the first embodiment shown
in FIGS. 1-4 was divided vertically into left and right shells, 44
and 42 respectively. This embodiment facilitates the addition of a
probe latch 220 and other features shown in FIG. 11.
[0068] Using conventional techniques well known in the art, it is
possible to use only one electrically driven motor in place of the
two motors described for both the first and second embodiments of
the present invention. That is, a single motor may be used to both
rotate and advance the cutter 96. The motor may be incorporated
into the instrument so that the cutter rotation and cutter
advancement (axial movement) may occur either simultaneously or
separately. The motor may be located within the adapted handpiece
40 and be electrically connected to the power source 24 and the
control unit 342. The motor may also be outside the handpiece 40,
still electrically connected to the power source 24 and the control
unit 342, and mechanically engaged to the handpiece 40 by a single
flexible shaft.
[0069] FIG. 11 shows an isometric view of the probe lower shell 208
and the holster lower shell 222 of the biopsy instrument 201 of the
second embodiment of the present invention. The view is shown with
the bottom side up in order to clearly present a probe latch 220
which is molded as a cantilever into the probe lower shell 208, and
can be deflected downwards by a force applied to a latch ramp
surface 223. The latch 220 further comprises a latch projection 219
for insertion into a holster slot 224 as the probe assembly is
inserted into the holster 221. The ramp surface 220 is deflected
downwards by interaction with an inside surface 225 of the holster
shell 222 and retainably snaps into a slot key 226 when the probe
assembly is fully inserted into the holster, thus rotationally
engaging the left and right couplers, 240 and 238, to the drive
shaft 212 and the gear shaft 210, respectively, as shown in FIG.
10. To remove the probe assembly from the holster, one must press
on the projection 219 while pulling them apart. FIG. 12 shows a
longitudinal section through the center axis of the probe lower
shell 208 and the holster lower shell 222 of FIG. 11 for when they
are fully attached together.
[0070] FIG. 13 is an exploded isometric view of a holster 251 of a
third embodiment of the present invention. It may be used with the
probe assembly 40 of the first embodiment shown in FIGS. 1-4. A
first and a second rotatable shafts, 264 and 266, are attached by a
grommet 262 to a drive shaft 258 and a screw shaft 260,
respectively. Rotatable shafts, 264 and 266, are preferably
flexible too, in order for the holster 251 combined with the probe
assembly 40 (see FIG. 2) to be easily manipulatable with one hand.
A fully integral rotation sensor 268 is shown mounted on a screw
shaft 260. This rotation sensor 268 is a miniature optical encoder
which is commercially available as Model Number SEH17 from CUI
Stack, Inc. It is electrically connected to a switch board 274
which mounts to the inside of the holster upper shell 252. The
switch board 274 also has a ribbon cable 270 containing a plurality
of conductors for conveying electronic information to and from the
control unit 342, power transmission source 24, and the fluid
collection system 22, via a control cable 265. The switch board 274
has mounted on its distal end, three switches, 276, 278, and 280,
for operation of the present invention in the same manner as
described in the first embodiment: a third switch 280 for fluidic
connection to the vacuum of the fluid collection system; a first
switch 246 for the forward movement of the cutter 96; and a second
switch 248 for the reverse movement of the cutter 96. The specific
functions of the switches, 276, 278, and 280, are not restricted,
in other possible embodiments of the present invention, to the
functions described, nor to the physical locations shown. The
switches, 276, 278, and 280, project through switch openings 254 of
the holster upper shell 252. A holster lower shell 256 attaches to
the upper shell 252 as in the other embodiments to enclose the
components of the proximal portion of the holster 251.
[0071] Those skilled in the art could easily appreciate that the
switch board 274 and the three switches, 276, 278, and 280, may
instead be incorporated into a foot operable device rather than in
the hand operable holster 251 shown in FIG. 13. The operator would
still be able to manipulate the instrument with a single hand while
actuating the switches, 276, 278, and 280, by foot, thus freeing
the other hand for holding the ultrasound imaging device, or for
performing other steps in the surgical procedure.
[0072] FIG. 14 shows the relationship of the electro-mechanical
components of the present invention the control unit 342. The third
embodiment of the present invention is depicted and includes the
holster 251 of FIG. 13. A first motor/tachometer combination 338
(sometimes referred to as a first motor/tach) and a second
motor/tachometer combination 340 (sometimes referred to as a second
motor/tach) are depicted as part of the power transmission source
24, and transmit rotational power to the holster 251 via the first
and second rotatable shafts, 264 and 266, respectively. The
motor/tach combinations, 340 and 348, are commercially available as
DC MicroMotors Series 3863, MicroMo Electronics, Inc. The control
cord 265 is electrically connected to a serial controller 380
available as Part No. MCF5206eFT40 from Motorola, Inc. A serial
controller 380 is electronically connected to the switchboard 274
by ribbon cable 270 and control cord 265. The serial controller 380
coordinates information exchange across the serial communication
link between the switchboard 274 and the microprocessor 408. An
advantage provided by the use of the serial controller 380 is that
the required number of conductors 193 may be reduced.
[0073] FIG. 14 depicts the interconnection of the
electro-mechanical components of the fluid collection system 22 and
power transmission source 24 with control unit 342. The first
vacuum tube 94 coming from the probe assembly 40 (see FIG. 2) is
attached to a first vacuum Y-connector 302 fluidly connected a
first upper line 306 and a first lower line 308. The two lines, 306
and 308, pass through a first pinch valve 314. A suitable,
commercially available, three-way pinch valve for this application
is Model Number 373 12-7 15 available from Angar Scientific
Company, Inc. The pinch valve 314 closes either the upper line 306
or the lower line 308, but never both lines simultaneously. The
lower line 308 provides a vent to atmospheric pressure. The upper
line 306 attaches to a fluid collection canister 318. Similarly,
the second vacuum line 136 from the probe assembly 40 attaches to a
second Y-connector 304 which fluidly is connected to a second upper
line 310 and a second lower line 312. The first and second vacuum
Y-connectors, 302 and 304, are molded from a rigid polymer such as
polycarbonate The second upper line 310 passes through a second
pinch valve 316, which is identical to the first, and to the
canister 318. The second lower line 312 passes through the second
pinch valve 316 and vents to atmosphere. Again, only one or the
other of the two lines may be pinched closed at any time.
[0074] Still referring to the fluid collection system of FIG. 14, a
main vacuum line 320 attaches the canister 318 to an electrically
powered vacuum pump 330. A suitable vacuum pump for this
application is available by the trademark name WOB-L PISTON Series
2639, from Thomas Compressors and Vacuum Pumps. The main vacuum
line 320 passes through a regulator valve 322 to electronically
adjust the vacuum pressure supplied to the canister 318. A
commercially available regulator valve for this application is
model number VSONC 6 S 11 V H Q 8 from Parker Hannifin Corp.,
Pneutronics Division. A pressure sensor 328 is fluidly attached to
the main vacuum line 320 at a sensor connection 324. The signal
from the pressure sensor 328 is sent to an A/D converter 396 of the
control unit 342. A commercially available, compensated pressure
sensor for this application is model number SDX15 from SenSym,
Inc.
[0075] At the heart of the control unit 342 is a 40 MHz, 32 bit
microprocessor 408, available from Motorola, Inc. as Part No.
MCF5206EFT40, which is designed to perform logic operations that
eventually translate into simple electromechanical actions.
[0076] Still referring to FIG. 14, the control unit 342 includes a
640.times.480 color TFT-LCD display 334 available from Sharp as
part number LQ64D343. Display 334 is covered by a resistive
touchscreen 336 for the user interface. The touch screen 336 is
available from Dynapro as part number 95638, and is electronically
connected to a touch screen controller 402 in the control unit 342.
The touchscreen controller 402 interfaces with the microprocessor
408 and comprises the following: a microcontroller, part number
PIC16C58A, available form Microchip; an EEPROM, part number
93AA466SN, available from Microchip; an A-D converter, part number
TLV1543CDW, available from Texas Instruments; and a
multiplexer-demultiplexer, part number MC74HC4052D, available from
Motorola. The touch screen controller allows the control unit 342
to respond to the user's touch by interpreting touch inputs.
Similarly, an LCD controller 404 is an interface between the
microprocessor 408 and the LCD display 334. The LCD controller 404
reduces the burden of the microprocessor 408 by efficiently
controlling display parameters such as color, shading, screen
update rates, and it typically accesses the memory chips of the
microprocessor 408 directly. The LCD controller 404 comprises the
following: a LCD controller, part number SED1354FOA, available from
Epson; a display buffer DRAM, part number MT4LC1M16E5TG-6,
available from Micron; and a line driver, part number
74ACTQ16244SSCX, available from National.
[0077] A miniature annunciator 332 is provided with the control
unit 342 in order to provide the user with audible, feedback
"beeps" upon each activation of an icon control on the LCD display
334. A suitable annunciator, for this application is model number
EAS-45P104S from Panasonic (Matshusita Electric Corp. of America).
The annunciator 332 interfaces with the microprocessor 408 by an
oscillator 400 which converts the digital input signal from the
microprocessor 408 to an analog, periodic output signal, thus
controlling the audio frequency of the speaker. The volume of the
sound coming from the annunciator 332 is controlled by a
programmable attenuator. The oscillator 400 comprises the
following: a 8 MHz oscillator, part number ASL-8.0000000-PCSA,
available from AMD; and a PLD, part number EPM7256ATC144-7, from
Altera.
[0078] Still referring to the schematic diagram of FIG. 14, a first
motor controller and driver 390 interfaces the second electric
motor/tach 340 with the microprocessor 408. The first motor
controller and driver 390 comprises the following: an H-bridge,
part number LMD18200T, available from National; a motion
controller, part number LM629M-8, available from National; and a
PLD, part number EPM7256ATC144-7, available from Altera. The second
motor/tach 340 is operationally connected to the second flexible
shaft 266 for the actuation of the cutter axial transmission 121
(see FIG. 4). The controller and driver 390 converts digital input
signals from the microprocessor 408 into analog motor input signals
for controlling motor rotational direction and speed. A closed loop
digital speed control of the motor is also achieved within the
controller and driver 390 using feedback signals from the rotation
sensor 268 available from CUI Stack, Inc., as part number SEH17
(see FIG. 13). The first electric motor/tach 338 drives the cutter
rotational transmission 109 (see FIG. 4) via the first rotatable
shaft 264. The first electric motor/tach 338 interfaces with the
microprocessor through the second controller and driver 406.
[0079] An optional card reader 382 may be provided in the control
unit 342 for reading data from memory card in order to facilitate
future software upgrades and servicing.
[0080] A serial port 384 is provided for the bi-directional data
exchange in a serial transmission mode, again to facilitate future
software upgrades and servicing. The serial port 384 comprises the
following: a UART, part number ST16C2552CJ44, available from EXAR;
and a line driver-receiver, part number DS14C335MSA, available from
National.
[0081] A first PWM (pulse width modulation) driver 386 interfaces
the first pinch valve 314 with the microprocessor 408. The first
PWM driver 386 converts a digital input signal from the
microprocessor 408 to an analog output signal having a wave of
fixed frequency and amplitude, but varying duty cycle. To drive the
solenoid in the pinch valve 314, the PWM driver 386 is used when
the duty cycle is high to initially move the solenoid. Once the
pinch valve 314 is actuated, the duty cycle is reduced to a level
which maintains valve position, thus minimizing power requirements.
A second PWM driver 388 similarly interfaces a second pinch valve
316 with the microprocessor 408. A third PWM driver 394 interfaces
with the regulator valve 322. The PWM drivers, 394, 388, and 386
each comprise the following: a PLD, part number EPM7256ATC144-7,
available from Altera; and a FET transistor, part number NDS9945,
available from Fairchild.
[0082] A RAM memory device 392 available from Micron as DRAM part
number MT4LC1M16E5TG-6, is provided with the microprocessor 408,
and inherently loses stored data when power is removed. A flash
memory device 398, on the other hand, is provided with the
microprocessor 408 to store data even without continuous power, but
it has slower access time than the RAM device 392. The flash memory
device 398 is part number Am29LV800BT-70REC from AMD.
[0083] An A/D converter 396 converts voltage signals from the
pressure sensor 328 into digital signals to the microprocessor 408,
for maintaining the desired vacuum pressure in the fluid collection
system 22. The A/D converter 396 is part number-PCF8591AT,
available from Philips.
[0084] Still referring to FIG. 14, the first (axial) controller and
driver 390 and the second (rotational) controller and driver 406
continually calculate and update the axial and rotational position
of the cutter 96 within the handpiece 20. They also calculate the
speed and acceleration of the cutter 96 axial and rotational
movement from the positional information. The microprocessor 408
monitors both the axial position and speed of the cutter 96 and the
rotational position and speed via the first controller and driver
390 and the second controller and driver 406.
[0085] While in the sampling mode and with the cutter 96 advancing
toward the third position (proximal to port 78), when the cutter 96
reaches a predetermined axial position, the microprocessor 408
sends a signal to the second controller and driver 406 to initiate
cutter rotation. The rotational speed of the cutter 96 follows a
predefined speed profile which insures that the cutter rotational
speed is at Z revolutions per minute (rpm) when the cutter 96
reaches the third position. When the cutter 96 reaches the third
position, the microprocessor 408 sends a signal to the first
controller and driver 390 to advance the cutter 96 at speed Y. The
cutter 96 then progresses through the port 78 at advancement speed
Y while rotating at velocity Z. While advancing through the port
78, the cutter rotational speed is monitored by the second
controller and driver 406. If the rotational speed is greater than
Z rpm, electrical current to the first (cutter rotation) motor/tach
338 is decreased. If the cutter rotational speed is less than Z
rpm, electrical current to the first motor/tach 338 is increased.
One method of performing the speed control on both the first and
second motor/tach's, 338 and 340, is to generate an error signal
based on the difference between the desired speed and the actual
speed. The error signal is then input into a proportional,
differential, and derivative (PID) digital filter which is part of
the respective controller and driver, either 390 or 406. The sum of
these three terms is used to generate the pulse width modulation
(PWM) signal. The generation of the error signal and the PWM signal
is accomplished by the first and second controllers and drivers,
390 and 406. A PWM signal is input to the first controller and
driver 390 to generate an analog output signal to drive the first
motor/tach 338. Similarly, a PWM signal is input to the second
controller and driver 406 to generate an analog output signal to
drive the second motor/tach 340.
[0086] The microprocessor 408 also monitors the output value of the
second controller and driver 406 PID filter such that if it exceeds
a predefined maximum value, it will reduce the axial speed of the
cutter 96 a set amount by sending an updated speed command to the
first controller and driver 390. This closed-loop algorithm is
intended to insure that the target rotational speed is attained by
decreasing the axial speed of the cutter 96 under maximum loading
conditions. The control logic then repeats from the beginning.
[0087] FIG. 15 is an enlarged view of the LCD display 334 and the
touch screen 336, shown as part of the control unit 342 of FIG. 14.
In one embodiment of the present invention, twelve separate
operating modes are available to a user. A control switch for each
operating mode is displayed graphically on LCD display 334 in the
form of icons, 346, 348, 350, 352, 354, 356, 358, 360, 362, 364,
366, and 368. The user may initiate a particular operation by
pressing the touch screen in the region of the appropriate icon
using at the appropriate time during the surgical procedure to
electronically control the operation of the biopsy device. The
present invention is not restricted to use with the particular
combination of modes of operation shown in FIG. 15.
[0088] For the following description of the modes of operation, it
will be assumed for discussion purposes that the first embodiment
of the present invention is being described, and that the first
switch 146 primarily controls the forward (distal direction) axial
movement of the cutter 96, the second switch 148 primarily controls
the reverse (proximal direction) axial movement of the cutter 96,
and that the third switch 150 primarily controls the fluidic
connection of the handpiece 20 to the fluid collection system 22.
The switches, 146, 148, and 150, also have secondary functions such
as setting the control unit 342 for particular steps during the
operation of the instrument, and these secondary functions are
described later. The modes of operation are also applicable to the
second embodiment of the present invention which includes first
switch 276, second switch 278, and third switch 280.
[0089] Each mode of operation is utilized for a particular portion
of the general biopsy procedure. The "Prime" mode of operation is
selected when the operator is preparing the instrument for use.
When an operator activates the "Prime" mode of operation by, for
example, touching the LCD display 344 in the region of icon 346,
the display 334 indicates the status as being "Prime Mode". The
cutter 96 then translates to the third position just proximal to
the port 78. Once the cutter is in the third position, the display
instructs the operator to apply saline to the port 78 and to
depress the vacuum switch 150 as needed to draw saline into piercer
70 and through the probe assembly 40. The operator may observe the
flow of saline through the window 58. Finally, the first pinch
valve 314 and second pinch valve 316 are both set to respond to the
vacuum switch 150.
[0090] The "Insert" mode of operation is next selected when the
operator is preparing the instrument for insertion into the tissue
of the surgical patient. When an operator activates the "Insert"
mode of operation by, for example, touching the LCD display 344 in
the region of Icon 348, the display 344 indicates the status as
being "Insert Mode". The cutter 96 then translates to the fourth
position, just distal to the port 78. Once the cutter 96 translates
to the fourth position, the display indicates that the instrument
is ready to insert.
[0091] The "Verify" mode of operation is selected when the operator
wants to verify that the position of the port 78 is adjacent to the
tissue to be extracted. In order to more easily visualize the port
78 of the inserted piercer 70 on the imaging device, it has been
found that the cutter 96 should be retracted to a position proximal
to the port 78, that is, the port 78 should be "open." If the port
78 is not adjacent to the tissue to be extracted, then the operator
should "close" the port 78 by moving the cutter 96 to the fourth
position, so that the piercer 70 may be hand-manipulated towards
the tissue to be extracted. Then the port 78 should be opened again
to verify that the port 78 is adjacent to the tissue to be
extracted. These steps are repeated until the port 78 is adjacent
the tissue to be extracted. When an operator activates the "Verify"
mode of operation by, for example, touching the LCD display 344 in
the region of Icon 350, the display 344 indicates the status as
being "Verify Mode". If the cutter 96 is not at the fourth position
(the port 78 is "open"), the second motor 340 is set to respond to
the handpiece first (forward) switch 146. Then the display 344
instructs the operator to close the port 78 by pressing the first
(forward) switch 146 on the handpiece 20. When the operator presses
the first (forward) switch 146, the cutter 96 translates to the
fourth position. The second motor 340 is then set to respond to the
handpiece second (reverse) switch 148. If the cutter 96 is already
at the fourth position when the "Verify" mode is selected, then the
second motor 340 is set to respond to the second (reverse) switch
148. Then the display 344 instructs the operator to open the port
78 by pressing the second (reverse) switch 148 on the handpiece.
When the operator presses the second (reverse) switch 148, the
cutter 96 translates to the third position just proximal to the
port 78. Then the second motor 340 is set to respond to the first
(forward) switch 146.
[0092] The "Sample" mode of operation is selected when the operator
desires to extract a portion of tissue from the surgical patient.
When the operator activates the "Sample" mode of operation by, for
example, touching the LCD display 344 in the region of icon 352,
the display 344 indicates the status as being "Sample Mode". The
cutter 96 then translates to the third position which is just
proximal to the port 78. Then the second motor 340 is set to
respond to the first (forward) switch 146. Once the cutter 96 is in
the third position, the display 344 instructs the operator to take
a tissue sample by pressing the first (forward) switch 146 on the
handpiece. When the first (forward) switch 146 is pressed, the
first pinch valve 314 and second pinch valve 316 are opened, and
the first motor 338 is activated to rotate the cutter 96 at the
appropriate speed. Then the cutter 96 translates to the fourth
position, severing the tissue portion prolapsed into the port 78 as
the cutter 96 moves distally. Once the cutter 96 reaches the fourth
position, the first motor 338 is deactivated and the cutter 96
stops rotating. Then the first pinch valve 314 is activated to
close. Next the display 344 instructs an operator to retrieve a
tissue sample by pressing, the second (reverse) switch 148 on the
handpiece 20. The second motor is set to respond to the second
(reverse) switch 148 on the handpiece 20. When the operator presses
the second (reverse) switch 148, the cutter 96 translates to the
first, fully retracted position, just distal to the sampling
surface 64. Then the second pinch valve 316 is activated to close
the vacuum for the tissue remover 132. A "smart vacuum" is also
activated and a plurality of vacuum pulses (0.5 seconds on and 0.5
seconds off) are supplied to the second vacuum tube 136. A detailed
description of the "smart vacuum" is provided in U.S. patent
application Ser. No. 08/878468 filed by the same assignee as for
the present application and which is incorporated herein for
reference. The display 344 instructs the operator to remove the
tissue sample. If there was no sample extracted, that is, the
severed tissue portion remained at the distal end of the piercer 70
rather than be deposited onto the tissue sample surface 64, the
operator is instructed to select "Dry Tap". The operator is also
instructed to select "Remove Air/Blood" if required to remove
excessive fluids in the patient and probe assemble 40. The operator
is finally instructed to press the first (forward) switch 146 on
the handpiece 20 to extract the next sample. Next, the second motor
340 is set to respond to the first (forward) switch 146 on the
handpiece 20. When the first (forward) switch 146 is pressed by the
operator, the "smart-vacuum" is stopped and the first and second
pinch valves, 314 and 316, are activated to open, and the cutter 96
translates in the distal direction. As the cutter 96 approaches the
third position just proximal to the port 78, the first motor 338 is
activated to rotate the cutter 96 which then translates to the
fourth, fully distal position. Then the cutter 96 rotation is
stopped and the first pinch valve 314 is closed to stop the vacuum
to the vacuum pressure chamber tube 76 supplied by the first vacuum
tube 94.
[0093] The "Mark" mode of operation is selected when the operator
desires to implant a metallic marker within the surgical patient at
the location from which the tissue was extracted. When the operator
activates the "Mark" mode of operation by, for example, touching
the display 344 in the region of icon 354, the display 344
indicates the status as being "Marker Mode" and also prompts the
operator to select "Dry Tap" if required. Then the operator is
instructed to press the third (vacuum) switch 150 on the handpiece
20 to activate the "Mark" mode. A marking instrument which may be
used in combination with the present invention for marking tissue
is commercially available under the tradename MICROMARK from
Ethicon Endo-Surgery, Inc., Cincinnati, Ohio. A complete
description of the MICROMARK applier and clip, and the method of
its use, is included in U.S. patent applications Ser. No.
09/105,757 and Ser. No. 09/105,570, both filed on Jun. 26, 1998,
and which are incorporated herein for reference. When the operator
presses the third (vacuum) switch 150, the cutter 96 translates to
the first position just proximal to the tissue sampling surface 64.
The display 344 then instructs the operator to insert the MICROMARK
instrument, to press the third (vacuum) switch 150 on handpiece
when ready to deploy, and to deploy the marker. Then when the third
(vacuum) switch 150 is pressed, the first pinch valve 314 is
activated to the open position for five seconds to supply vacuum to
the port 78 through the vacuum chamber 76. Next the display 344
instructs the operator to reposition the MICROMARK instrument if
marker deployment was not complete, to press the third (vacuum)
switch 150 on the handpiece when ready to deploy the marker, to
deploy the marker, and if the marker deployment is complete, to
remove the MICROMARK instrument.
[0094] The "Remove" mode of operation is selected when the operator
is ready to remove the piercer 70 from within the tissue of the
surgical patient. When the operator activates the "Remove" mode of
operation by, for example, touching the display 344 in the region
of icon 356, the display 344 indicates the status as being "Remove
Mode". The cutter 96 translates to the fourth, fully distal
position and closes the port 78. The display 344 instructs the
operator that the instrument is ready to remove.
[0095] The "Remove Air/Blood" mode of operation is selected when
the operator desires to remove any fluids present near the distal
end of the piercer 78 and within the probe assembly 40. When the
operator activates the "Remove Air/Blood" mode of operation by, for
example, pressing the display 344 in the region of icon 360, the
display 344 indicates the status as being "Remove Air/Blood Mode".
The cutter 96 then translates to the third position just proximal
to the port 78. The first pinch valve 314 and the second pinch
valve 316 are both set to respond to the third (vacuum) switch 150
on the handpiece 20. The display then instructs the operator to
remove the air/blood by pressing the third (vacuum) switch 150 on
the handpiece 20. When the third (vacuum) switch 150 is pressed,
the first pinch valve 314 and the second pinch valve 316 are
activated to open for five seconds. When they are closed, the
cutter 96 then translates to the first, fully retracted position
just proximal to the tissue sampling surface 64. Then the "Remove
Air/Blood" mode is automatically exited and the previous mode
selected is automatically reset.
[0096] The "Dry Tap" mode of operation is selected when the
operator had attempted to extract a tissue portion from the
surgical patient using the "Sample" mode of operation, but a tissue
portion was not deposited onto the tissue sample surface 64. This
may occur when the tissue portion is properly severed from the
surgical patient, but remained in the distal end of the piercer 78.
When the operator activates the "Dry Tap" mode of operation by, for
example, touching the display 344 in the region of icon 358, the
display 344 indicates the status as being "Dry Tap Mode". The
cutter 96 then translates to the third position just proximal to
the port 78. Then the second pinch valve 316 is activated to open
for 0.5 seconds and to close for 0.5 seconds three times in order
to pulse the vacuum supplied to the tissue remover 132 through the
second vacuum tube 136. The cutter 96 then translates to the first,
fully retracted position just proximal to the tissue sampling
surface 64. The "Dry Tap" mode of operation is then exited and the
previously selected mode of operation is automatically
selected.
[0097] The "Flush" mode of operation is selected when the operator
desires to clear any obstructions (tissue fragments, etc.) on the
distal end of the tissue remover 132 to enable the passage of
fluids through it. When an operator activates the "Flush" mode of
operation by, for example, touching the display 344 in the region
of icon 362, the display 344 indicates the status as being "Flush
Mode". The cutter 96 then translates to the first, fully retracted
position, thus exposing the distal end of the tissue remover 132.
Then the control unit 342 is set to respond to the vacuum switch
150, which when pressed by the operator, causes the "Flush" mode of
operation to be exited and the previously selected mode of
operation to be automatically reset. Before pressing the vacuum
switch 150, however, the operator may temporarily disconnect the
second connector 304, inject fluid such as saline into the second
vacuum tube 136 using a syringe, and reconnect the second connector
304.
[0098] The "Inject" mode of operation is selected when the operator
desires to inject a fluid, such as a local anesthetic, into the
tissue surrounding the distal end of the piercer 78. When the
operator activates the "Inject" mode of operation by, for example,
touching the display 344 in the region of icon 364, the display 344
indicates the status as being "Inject Mode". The cutter 96 then
translates to the third position just proximal to the port 78. Then
the control unit 342 is set to respond to the third (vacuum) switch
150 on the handpiece 20. Next the display instructs the operator to
inject the fluid into the second vacuum tube 136, and to press the
third (vacuum) switch 150 again once the injection is complete.
When the operator has completed the injection into the second
vacuum tube 136, reconnected it to the fluid collection system 22,
and pressed the third (vacuum) switch 150, the cutter 96 translates
to the first, fully retracted position. At that point, the "Inject"
mode of operation is exited, and the previously selected mode of
operation is automatically reset.
[0099] Each time one of the available operating modes is selected,
a display area 344 provides written and graphic information to
prompt the user as to the correct usage of the instrument and the
next operational steps. A mode indicator display 370 includes a
representation of the probe assembly showing the instantaneous
position of the cutter tube, referred to as a cutter position
indicator 373, activation of the front vacuum indicator 372
(corresponding with the first vacuum tube 94), and activation of
the rear vacuum indicator 371 (corresponding with the second vacuum
tube 136).
[0100] The present invention, as described, is transportable from
room to room of a physician's office, primarily because the
handpiece need not be mounted to an X-ray stereotactic table. The
remaining portions of the instrument, including the fluid
collection system, the power transmission source, and the control
unit, may be packaged into a portable, wheeled unit. In one
scenario, the physician would have a number of patients, each in a
separate room, being prepared for treatment while the surgical
procedure is being performed on another patient. The biopsy
instrument could then be moved to the patient, rather than vice
versa, thus helping the patient to feel relaxed and prepared for
the procedure. A different, sterile probe assembly would be
provided for each patient, while the holster portion of the
handpiece would be reused.
[0101] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. Accordingly, it is intended that the invention be
limited only by the spirit and scope of the appended claims.
* * * * *