U.S. patent number RE46,135 [Application Number 13/507,652] was granted by the patent office on 2016-09-06 for vacuum syringe assisted biopsy device.
This patent grant is currently assigned to Devicor Medical Products, Inc.. The grantee listed for this patent is John A. Hibner. Invention is credited to John A. Hibner.
United States Patent |
RE46,135 |
Hibner |
September 6, 2016 |
Vacuum syringe assisted biopsy device
Abstract
A biopsy device and method are provided for obtaining a tissue
sample, such as a breast tissue biopsy sample. The biopsy device
includes a disposable probe assembly with an outer cannula having a
distal piercing tip, a cutter lumen, and a cutter tube that rotates
and translates past a side aperture in the outer cannula to sever a
tissue sample. The biopsy device also includes a reusable handpiece
with an integral motor and power source to make a convenient,
untethered control for use with ultrasonic imaging. The reusable
handpiece incorporates a probe oscillation mode to assist when
inserting the distal piercing tip into tissue. The motor also
actuates a vacuum syringe in coordination with movement of the
cutter tube to provide vacuum assistance in prolapsing tissue and
retracting tissue samples.
Inventors: |
Hibner; John A. (Mason,
OH) |
Applicant: |
Name |
City |
State |
Country |
Type |
Hibner; John A. |
Mason |
OH |
US |
|
|
Assignee: |
Devicor Medical Products, Inc.
(Cincinnati, OH)
|
Family
ID: |
56878442 |
Appl.
No.: |
13/507,652 |
Filed: |
July 16, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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11198558 |
Aug 5, 2005 |
7867173 |
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Reissue of: |
11465143 |
Aug 17, 2006 |
7828748 |
Nov 9, 2010 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
10/0096 (20130101); A61B 10/0275 (20130101); A61B
10/0275 (20130101); A61B 10/0266 (20130101); A61B
2010/0225 (20130101); A61B 2017/0046 (20130101); A61B
10/0283 (20130101); A61B 2010/0208 (20130101); A61B
2017/0046 (20130101) |
Current International
Class: |
A61B
10/00 (20060101); A61B 10/02 (20060101); A61B
17/00 (20060101) |
Field of
Search: |
;600/562-568 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2581264 |
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Sep 2007 |
|
CA |
|
0890339 |
|
Jan 1999 |
|
EP |
|
0 995 400 |
|
Apr 2000 |
|
EP |
|
1 520 518 |
|
Apr 2005 |
|
EP |
|
1 642 533 |
|
Apr 2006 |
|
EP |
|
1 832 234 |
|
Dec 2007 |
|
EP |
|
1889573 |
|
Feb 2008 |
|
EP |
|
1 932 482 |
|
Jun 2008 |
|
EP |
|
2 018 601 |
|
Oct 1979 |
|
GB |
|
2397242 |
|
Jul 2004 |
|
GB |
|
2021770 |
|
Oct 1994 |
|
RU |
|
WO 03/077768 |
|
Sep 2003 |
|
WO |
|
WO 2004/016177 |
|
Feb 2004 |
|
WO |
|
WO 2004/052179 |
|
Jun 2004 |
|
WO |
|
WO 2004/052212 |
|
Jun 2004 |
|
WO |
|
WO 2004/075728 |
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Sep 2004 |
|
WO |
|
WO 2006/005342 |
|
Jan 2006 |
|
WO |
|
WO 2006/005343 |
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Jan 2006 |
|
WO |
|
WO 2006/124489 |
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Nov 2006 |
|
WO |
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WO 2007/019152 |
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Feb 2007 |
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WO |
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WO 2007/021904 |
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Feb 2007 |
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WO |
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WO 2007/112751 |
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Oct 2007 |
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WO |
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Other References
European Search Report dated Dec. 1, 2005 for Application No. EP
05256035. cited by applicant .
European Search Report dated Jun. 13, 2007 for Application No.
07250402. cited by applicant .
European Search Report dated Dec. 11, 2007 for PCT Application No.
07253220. cited by applicant .
European Search Report dated Dec. 20, 2007 for EPO Application No.
07253220. cited by applicant .
European Examination Report dated May 13, 2008 for Application No.
EP 07250402. cited by applicant .
European Search Report dated Sep. 29, 2010 for Application No. EP
10251076. cited by applicant .
European Search Report dated Apr. 5, 2012 for Application No. EP
11193357. cited by applicant .
European Communication dated Jun. 25, 2007 for Application No. EP
05256035. cited by applicant .
International Search Report dated Jul. 18, 2007 for Application No.
PCT/US 06/30022. cited by applicant .
Written Opinion dated Apr. 26, 2010 for Application No. EP
08252524. cited by applicant .
Rejection dated Apr. 4, 2008 for U.S. Appl. No. 11/736,117. cited
by applicant .
Final Rejection dated Sep. 26, 2008 for U.S. Appl. No. 11/782,961.
cited by applicant .
US Re Issue U.S. Appl. No. 13/672,037 filed Nov. 8, 2012. cited by
applicant .
U.S. Appl. No. 14/040,798, filed Sep. 30, 2013. cited by applicant
.
Australian Patent Examination Report No. 1, dated Sep. 23, 2014,
for Application No. AU 2012216247. cited by applicant .
Australian Notice of Acceptance, dated Nov. 30, 2015, for
Application No. AU 2012216247. cited by applicant .
Australian Patent Examination Report No. 1, dated Sep. 5, 2014 for
Application No. AU 2013205334. cited by applicant .
Canadian Office Action dated Jul. 8, 2014 for Application No. CA
2,597,847, 2 pgs. cited by applicant .
Canadian Office Action dated Sep. 7, 2015 for Application No. CA
2,597,847, 3 pgs. cited by applicant .
Indian Office Action dated Jul. 31, 2014 for Application No.
521/KOLNP/2008, 2 pgs. cited by applicant .
U.S. Appl. No. 60/874,792, filed Dec. 13, 2006, Hibner, John A.
cited by applicant .
U.S. Appl. No. 60/869,736, filed Dec. 13, 2006, Hibner, John A.
cited by applicant .
U.S. Appl. No. 11/782,893, filed Jul. 25, 2007, Garrison, William.
cited by applicant .
EnCor MRI Specifications and Breast Biopsy System, SenoRx, 2005,
pp. 102. cited by applicant .
ISR dated Jul. 18, 2007 for PCT Application No. PCT/US 06/30022.
cited by applicant .
Non-final Rejection dated Mar. 20, 2008 for U.S. Appl. No.
11/782,963. cited by applicant .
Final Rejection dated Sep. 26, 2008 for U.S. Appl. No. 11/782,963.
cited by applicant .
Non Final Rejection dated Oct. 6, 2008 for U.S. Appl. No.
11/736,117. cited by applicant .
International Search Report dated Sep. 27, 2007 for Application No.
PCT/US06/30022. cited by applicant .
International Search Report dated Dec. 18, 2008 for Application No.
PCT/US2008/058627. cited by applicant .
European Search Report dated Nov. 14, 2007 for Application No.
07250926. cited by applicant .
European Search Report dated Apr. 3, 2009 for Application No.
08252518. cited by applicant .
European Search Report dated Apr. 3, 2009 for Application No.
08252524. cited by applicant .
European Examination Report dated Mar. 19, 2009 for Application No.
07250926. cited by applicant .
Patentability Report and Written Opinion dated Feb. 5, 2008 for
Application No. PCT/US2006/030022. cited by applicant .
Supplemental European Search Report dated Dec. 16, 2009 for
Application No. EP06789155. cited by applicant .
European Communication dated Apr. 26, 2010 for Application No.
08252524. cited by applicant.
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Primary Examiner: Flanagan; Beverly M.
Attorney, Agent or Firm: Frost Brown Todd LLC
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
The present application is a .Iadd.reissue of U.S. Pat. No.
7,828,748, "VACUUM SYRINGE ASSISTED BIOPSY DEVICE" to Hibner, filed
17 Aug. 2006, which is a .Iaddend.continuation-in-part of the
co-pending and commonly-owned U.S. patent application Ser. No.
11/198,558, "BIOPSY DEVICE WITH REPLACEABLE PROBE AND INCORPORATING
VIBRATION INSERTION ASSIST AND STATIC VACUUM SOURCE SAMPLE STACKING
RETRIEVAL" to Hibner et al., filed 5 Aug. 2005, .Iadd.issued as
U.S. Pat. No. 7,867,173, .Iaddend.the .[.disclosure.].
.Iadd.disclosures .Iaddend.of which .[.is.]. .Iadd.are
.Iaddend.hereby incorporated by reference in .[.its.]. .Iadd.their
.Iaddend.entirety. .Iadd.The present application is also related to
U.S. patent application Ser. No. 13/672,037, filed 8 Aug. 2012, a
reissue of U.S. Pat. No. 7,828,748, "VACUUM SYRINGE ASSISTED BIOPSY
DEVICE" to Hibner, filed 17 Aug. 2006, now abandoned..Iaddend.
Claims
What is claimed:
1. A biopsy device, comprising: a probe cannula defining an
internal passage; a proximal portion attached to the probe cannula
positionable to insert the probe cannula into tissue; a cutter
reciprocally received by the probe cannula to sever a tissue sample
received in the probe cannula; a pneumatic container attached with
the proximal portion and operably configured to communicate a low
pneumatic pressure contained within the pneumatic container with
the probe cannula; a motor contained in the proximal portion
operatively coupled to translate the cutter, wherein the motor is
further operatively coupled to reduce pneumatic pressure in the
pneumatic container; and a frame assembly positioned within the
biopsy device adjacent the proximal portion and attached to the
probe cannula, wherein the frame assembly is longitudinally movable
within the biopsy device, wherein the motor is further operably
configured to impart a longitudinal to reciprocating motion to the
frame assembly during insertion of the probe cannula into
tissue.
2. The biopsy device of claim 1, wherein the pneumatic container
comprises a vacuum syringe comprising a vacuum cylinder and a
plunger, the motor operatively coupled to the plunger.
3. The biopsy device of claim 1, wherein the probe cannula
comprises a cylindrical probe tube having a side aperture sized to
admit prolapsed tissue, the cutter comprising a cutter tube axially
offset within the probe tube to closely reciprocate past the side
aperture.
4. The biopsy device of claim 1, wherein the probe cannula
comprises a cutter lumen having a side aperture, the cutter
comprising a cutter tube sized to reciprocate within the cutter
lumen, further comprising a lateral lumen distally communicating
with the side aperture and defining the internal passage.
5. The biopsy device of claim 1, further comprising a straw
assembly positioned proximal to the cutter tube, the motor further
operatively configured to longitudinally translate the straw
assembly through the cutter tube to retract a severed tissue
sample.
6. The biopsy device of claim 5, further comprising a straw
carriage received on a translation shaft coupled to the straw
assembly.
7. The biopsy device of claim 1, further comprising a cutter
carriage received on a translation shaft coupled to the cutter.
8. The biopsy device of claim 7, wherein the pneumatic container
comprises a vacuum cylinder and plunger, the biopsy device further
comprising a vacuum pump shuttle retracted by movement of the
cutter carriage to position the plunger in the vacuum cylinder to
create a low pressure.
9. The biopsy device of claim 7, further comprising a vacuum
assistance valve operably switched by the cutter carriage to
communicate a low pressure from the pneumatic container to the
probe cannula.
10. The biopsy device of claim 1, further comprising a handpiece
cover containing a motor driven carriage assembly and comprising a
probe assembly, the probe assembly further comprising a cover
engageable to the handpiece cover and attached to the probe
cannula, the pneumatic container attached to a selected one of the
handpiece cover and the probe assembly cover.
11. The biopsy device of claim 1, wherein the probe cannula
comprises a cylindrical probe tube having a side aperture sized to
admit prolapsed tissue, the cutter comprising a cutter tube axially
offset within the probe tube to closely reciprocate past the side
aperture.
12. The biopsy device of claim 1, wherein the probe cannula
comprises a cutter lumen having a side aperture, the cutter
comprising a cutter tube sized to translate within the cutter
lumen, further comprising a lateral lumen distally communicating
with the side aperture and defining the internal passage.
13. The biopsy device of claim 1, further comprising a motor driven
carriage assembly and a straw assembly positioned proximal to the
cutter, the motor driven carriage assembly further operatively
configured to longitudinally translate the straw assembly through
the cutter to retract a severed tissue sample.
14. The biopsy device of claim 13, further comprising a translation
shaft rotated by the motor, and a straw carriage received on the
translation shaft coupled to the straw assembly.
15. The biopsy device of claim 1, further comprising a motor driven
carriage assembly and a translation shaft rotated by the motor,
wherein a cutter carriage is received on the translation shaft
coupled to the cutter.
16. The biopsy device of claim 15, wherein the pneumatic container
comprises a vacuum syringe comprising a vacuum cylinder and a
plunger, wherein the biopsy device further comprises a vacuum pump
shuttle retracted by movement of the cutter carriage to position
the plunger in the vacuum cylinder to create a low pressure.
.Iadd.17. A biopsy device, comprising: a biopsy needle including a
lateral tissue receiving feature; a low pneumatic pressure source
in fluid communication with the biopsy needle, wherein the low
pneumatic pressure source is operably configured to communicate a
low pneumatic pressure to the biopsy needle; a cutter
longitudinally translatable relative to the biopsy needle, wherein
the cutter is operable to sever tissue prolapsed into the lateral
tissue receiving feature of the biopsy needle; a valve assembly in
communication with the biopsy needle, wherein the valve assembly is
operable to selectively communicate atmospheric air to the biopsy
needle based on the longitudinal position of the cutter; a motor
operable to translate the cutter, wherein the motor is further
operable to actuate the low pneumatic pressure source while
simultaneously driving the cutter; and a frame assembly positioned
within the biopsy device and attached to the biopsy needle, wherein
the frame assembly is longitudinally movable within the biopsy
device, wherein the motor is further operably configured to impart
a longitudinal reciprocating motion to the frame assembly during
insertion of the biopsy needle into tissue..Iaddend.
.Iadd.18. The biopsy device of claim 17, wherein the lateral tissue
receiving feature is an aperture..Iaddend.
.Iadd.19. The biopsy device of claim 17, wherein the cutter is
longitudinally translatable within the biopsy needle..Iaddend.
Description
FIELD OF THE INVENTION
The present invention relates in general to biopsy devices, and
more particularly to biopsy devices having a cutter for severing
tissue, and even more particularly to biopsy devices for multiple
sampling with a probe remaining inserted.
BACKGROUND OF THE INVENTION
When a suspicious tissue mass is discovered in a patient's breast
through examination, ultrasound, MRI, X-ray imaging or the like, it
is often necessary to perform a biopsy procedure to remove one or
more samples of that tissue in order to determine whether the mass
contains cancerous cells. A biopsy may be performed using an open
or percutaneous method.
An open biopsy is performed by making a large incision in the
breast and removing either the entire mass, called an excisional
biopsy, or a substantial portion of it, known as an incisional
biopsy. An open biopsy is a surgical procedure that is usually done
as an outpatient procedure in a hospital or a surgical center,
involving both high cost and a high level of trauma to the patient.
Open biopsy carries a relatively higher risk of infection and
bleeding than does percutaneous biopsy, and the disfigurement that
sometimes results from an open biopsy may make it difficult to read
future mammograms. Further, the aesthetic considerations of the
patient make open biopsy even less appealing due to the risk of
disfigurement. Given that a high percentage of biopsies show that
the suspicious tissue mass is not cancerous, the downsides of the
open biopsy procedure render this method inappropriate in many
cases.
Percutaneous biopsy, to the contrary, is much less invasive than
open biopsy. Percutaneous biopsy may be performed using fine needle
aspiration (FNA) or core needle biopsy. In FNA, a very thin needle
is used to withdraw fluid and cells from the suspicious tissue
mass. This method has an advantage in that it is very low-pain, so
low-pain that local anesthetic is not always used because the
application of it may be more painful than the FNA itself. However,
a shortcoming of FNA is that only a small number of cells are
obtained through the procedure, rendering it relatively less useful
in analyzing the suspicious tissue and making an assessment of the
progression of the cancer less simple if the sample is found to be
malignant.
During a core needle biopsy, a small tissue sample is removed
allowing for a pathological assessment of the tissue, including an
assessment of the progression of any cancerous cells that are
found. The following patent documents disclose various core biopsy
devices and are incorporated herein by reference in their entirety:
U.S. Pat. No. 6,273,862 issued Aug. 14, 2001; U.S. Pat. No.
6,231,522 issued May 15, 2001; U.S. Pat. No. 6,228,055 issued May
8, 2001; U.S. Pat. No. 6,120,462 issued Sep. 19, 2000; U.S. Pat.
No. 6,086,544 issued Jul. 11, 2000; U.S. Pat. No. 6,077,230 issued
Jun. 20, 2000; U.S. Pat. No. 6,017,316 issued Jan. 25, 2000; U.S.
Pat. No. 6,007,497 issued Dec. 28, 1999; U.S. Pat. No. 5,980,469
issued Nov. 9, 1999; U.S. Pat. No. 5,964,716 issued Oct. 12, 1999;
U.S. Pat. No. 5,928,164 issued Jul. 27, 1999; U.S. Pat. No.
5,775,333 issued Jul. 7, 1998; U.S. Pat. No. 5,769,086 issued Jun.
23, 1998; U.S. Pat. No. 5,649,547 issued Jul. 22, 1997; U.S. Pat.
No. 5,526,822 issued Jun. 18, 1996; and US Patent Application
2003/0199753 published Oct. 23, 2003 to Hibner et al.
At present, a biopsy instrument marketed under the trade name
MAMMOTOME is commercially available from ETHICON ENDO-SURGERY, INC.
for use in obtaining breast biopsy samples. This device generally
retrieves multiple core biopsy samples from one insertion into
breast tissue with vacuum assistance. In particular, a cutter tube
is extended into a probe to cut tissue prolapsed into a side
aperture under vacuum assistance and then the cutter tube is fully
retracted between cuts to extract the sample.
With a long probe, the rate of sample taking is limited not only by
the time required to rotate or reposition the probe but also by the
time needed to translate the cutter. As an alternative to this
"long stroke" biopsy device, a "short stroke" biopsy device is
described in the following commonly assigned patent applications:
U.S. patent application Ser. No. 10/676,944, "Biopsy Instrument
with Internal Specimen Collection Mechanism" filed Sep. 30, 2003 in
the name of Hibner et al.; and U.S. patent application Ser. No.
10/732,843, "Biopsy Device with Sample Tube" filed Dec. 10, 2003 in
the name of Cicenas et al. The cutter is cycled across the side
aperture, reducing the sample time. Several alternative specimen
collection mechanisms are described that draw samples through the
cutter tube, all of which allow for taking multiple samples without
removing the probe from the breast.
The vacuum assistance presented at the side aperture provides a
further benefit of reducing the accumulation of bodily fluids
around the probe that may tend to interfere with taking a
diagnostic image, may impede subsequent insufflation and marker
deployment, leave an undesirable hematoma at the biopsy site,
and/or result in external bleeding that is a biohazard and may
increase the patient's discomfort.
While the vacuum assistance has a number of benefits, some
practitioners prefer to perform core biopsy procedures with simpler
devices that do not include a control module with graphical user
interface, electronic control, vacuum generation and control, and
other features. In addition to the desire to reduce capital costs,
it is also generally desirable to reduce the need to tether a
hand-held biopsy device to sources of mechanical motion, vacuum
supply, electrical power and control. Such tethers may tend to
impede positioning of the biopsy device, introduce tripping
hazards, and increase set up time.
Therefore, while these multiple sample core biopsy instruments have
numerous advantages, it is believed that the diagnostic and
therapeutic advantages of the core biopsy procedures would be seen
as more desirable if vacuum assistance could be incorporated in a
more convenient manner.
SUMMARY OF THE INVENTION
The present invention addresses these and other problems of the
prior art by providing a biopsy device that has a probe cannula
that is inserted into tissue to obtain a core biopsy sample by
translating a cutter with the probe cannula. Vacuum assistance to
prolapse tissue for sampling is advantageously provided by an
integral vacuum container whose internal pressure is reduced from
atmospheric pressure by actuation of a single motor that also
translates the cutter to sever biopsy samples.
In one aspect of the invention, a biopsy device handpiece has a
motorized translation drive mechanism that engages and operates a
disposable probe assembly that also translates a vacuum plunger of
a vacuum syringe. A cutter tube translating within a cutter lumen
severs tissue that is prolapsed therein under the urging from
vacuum supplied by the vacuum syringe.
These and other objects and advantages of the present invention
shall be made apparent from the accompanying drawings and the
description thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
While the specification concludes with claims particularly pointing
out and distinctly claiming the present invention, it is believed
the same will be better understood by reference to the following
description, taken in conjunction with the accompanying drawings in
which:
FIG. 1 is an isometric view of a biopsy device with attached vacuum
syringe assembly consistent with the present invention.
FIG. 2 is an isometric view of the biopsy device of FIG. 1 with a
disposable probe assembly that includes the vacuum syringe assembly
disengaged from a reusable handpiece that has a lower tray removed
to expose a carriage frame assembly and a motor drive assembly.
FIG. 3 is an isometric view of the reusable handpiece of FIG. 1
with a top cover detached with a left half cut away and with the
lower handle tray detached to expose the motor drive assembly
operatively engaged to the carriage frame assembly.
FIG. 4 is an isometric view of the motor drive assembly removed
from the carriage frame assembly of FIG. 3.
FIG. 5 is a bottom isometric view of the top cover of the reusable
handpiece of FIG. 2.
FIG. 6 is a top, left and aft isometric view of the carriage frame
assembly of FIG. 4.
FIG. 7 is a top, left and forward view of the carriage frame
assembly of FIG. 4 with an upper frame disassembled.
FIG. 8 is a top, left and front isometric view of the carriage
frame assembly of FIG. 4 with the upper frame removed.
FIG. 9 is a bottom isometric view of the carriage frame assembly of
FIG. 8 with the upper frame removed.
FIG. 10 is a top, left and front isometric exploded view of the
carriage frame assembly of FIG. 4.
FIG. 11 is a right front view of a transmission section of the
motor drive assembly of FIG. 4 with a distal bulkhead removed.
FIG. 12 is a front left exploded view of the transmission section
of the motor drive assembly of FIG. 4.
FIG. 13 is a front left isometric view of the disposable probe
assembly of FIG. 1 with a bottom cover, vacuum conduits and vacuum
syringe assembly disassembled.
FIG. 14 is a top detail view of a cutter gear and surrounding
components of the disposable probe assembly of FIG. 1.
FIG. 15 is a left front exploded view of a distal portion of the
disposable probe assembly of FIG. 1.
FIG. 16 is a left front exploded view of a proximal portion (vacuum
syringe assembly) of the disposable probe assembly of FIG. 1.
FIG. 17 is a bottom left isometric view of the distal internal
portion of the disposable probe assembly of FIG. 1 with the bottom
cover removed.
FIG. 18 is a left side section view of the disposable probe
assembly of FIG. 1 taken generally through a longitudinal axis and
omitting a probe cannula.
FIG. 19 is a left side diagrammatic view of an initial state of the
biopsy device of FIG. 1 with the vacuum syringe assembly omitted
and with both carriages distally positioned and engaged to the
disposable probe assembly.
FIG. 20 is a left side diagrammatic view of the biopsy device of
FIG. 1 with the vacuum syringe assembly omitted, depicted after
insertion of the probe cannula into tissue and the retraction of an
aft (straw) carriage that withdraws a straw from the cutter
tube.
FIG. 21 is a left side diagrammatic view of the biopsy device of
FIG. 1 with the vacuum syringe assembly omitted, depicted after
retraction of a front (cutter) carriage that positions a valve and
retracts a vacuum plunger to perform vacuum assistance within the
probe cannula.
FIG. 22 is a left side diagrammatic view of the biopsy device of
FIG. 1 with the vacuum syringe assembly omitted, depicted after
distal advancement of the front (cutter carriage) as the aft
(straw) carriage begins to distally translate to insert the straw
over a severed tissue sample and to reset the vacuum syringe
assembly.
DETAILED DESCRIPTION OF THE INVENTION
Turning to the Drawings, wherein like numerals denote like
components throughout the several views, in FIGS. 1-3, a biopsy
device 10 includes a reusable handpiece 12, and a disposable probe
assembly 14. A lower handle tray 16 is disassembled from upper
portions of the reusable handpiece 12 to expose portions that
operably engage the disposable probe assembly 14. A vacuum syringe
assembly 18 is a proximal portion of the disposable probe assembly
14 that is also actuated by the reusable handpiece 12. With the
close proximity of the source of vacuum, the amount of vacuum line
that needs to be evacuated is minimized, enabling a modestly sized
vacuum syringe assembly 18 to effect vacuum assistance to prolapse
tissue into a side aperture 20 of a probe cannula 22 of the
disposable probe assembly 14. In FIG. 3, further economy is
realized by employing one DC motor 24 in the reusable handpiece 12
to accomplish the severing of tissue samples as well as actuating
the vacuum syringe assembly 18.
With particular reference to FIG. 1, insertion of the probe cannula
22 into tissue is integrally supported by a piercing tip 26
attached at a distal end as well as a longitudinal jack hammer
motion to the probe cannula 22 selected by positioning a slide
button 28 distally and depressing a forward motor button 30. In
response, the DC motor 24 drives a. transmission section 31
grounded to a top cover 34 of the reusable handpiece 12 to
longitudinally reciprocate an internal carriage frame assembly 32
that is engaged for movement with the probe cannula 22 (FIG. 3).
With the slide button 28 proximally positioned, depression of the
forward motor button 30 causes the DC motor 24 to advance and
rotate a cutter tube 36, depicted in FIG. 1 as having been fully
distally translated, closing the side aperture 20. Depression of a
reverse motor button 38 causes the cutter tube 36 to retract.
Depression of a mode button 40 may cause other functions to be
performed. For example, fluid may be applied to or removed from the
biopsy device 10 via a valve (not shown), activated by mode button
40, inserted along distal vacuum conduit 330 (FIG. 13). An external
conduit 42 extends from the disposable probe assembly 14,
terminated by a filter/tube fitting 43. Vacuum assistance passes
through a lateral lumen 44 of the probe cannula 22 and distally
enters a cutter lumen 46 that encompasses the cutter tube 36 and
includes the side aperture 20. It should be appreciated that the
biopsy device 10 includes a minimum of "tethers" that would impede
use, pose a tripping hazard, or extend set-up time.
Alternatively, instead of "hard-walled" lateral lumen 44 separated
from the cutter lumen 46 along its length, applications consistent
with the present invention may have a cylindrical probe cannula
(not shown) wherein the cutter tube 36 is positioned off-center to
translate across a side aperture. A "soft-walled" lateral lumen may
then be defined as a space between an outer diameter of the cutter
tube and an inner diameter of the cylindrical probe cannula.
In FIG. 2, the disposable probe assembly 14 has a bottom cover 48
with a distal probe mount cover 50 that assists in supporting the
probe cannula 22 while allowing the longitudinal jack hammer
motion. A plurality of locking tabs 52 with locking edges 54 extend
upwardly through pass through slots 56 formed in the periphery of
the lower handle tray 16 to resiliently extend outwardly into
engaging contact with the slots 56. Relieved areas 58 formed behind
each locking tab 52 in a top extension member 59 that surrounds a
probe support body 60, the combination covering a cavity defined by
the bottom cover 48, allow depression of the locking tabs 52 to
unlock the disposable probe assembly 14 to install another
identical or similar assembly.
A proximal end of the cutter tube 36 receives a cutter gear 62
having distal and proximal reduced diameter bearing surfaces 64, 66
on each longitudinal side of a rotation spur gear section 68, which
engage the reusable handpiece 12 for rotation and for longitudinal
translation through a distally open longitudinal aperture 70 formed
in the lower handle tray 16. A straw assembly 72 is also engaged by
the reusable handpiece 12 through the longitudinal aperture 70 to
reciprocate longitudinally into a proximal opening of the cutter
tube 36 and cutter gear 62 to encompass and retract tissue samples.
A vacuum source conduit 74 communicates between the vacuum syringe
assembly 18 and the bottom cover 48 of the disposable probe
assembly 14.
In FIG. 3-13, the reusable handpiece 12 is depicted in various
states of disassembly to illustrate its operation. The transmission
section 31 is part of a rigidly mounted motor drive assembly 76
that includes the motor 24 in between a planetary gearbox 78 and an
encoder 80. Battery or other power sources and control circuitry
are omitted in the depictions. The motor drive assembly also
includes a right guide pin 82 and a left guide pin 84. The motor
drive assembly 76 is shown operably engaged to the longitudinally
reciprocating carriage frame assembly 32 in FIG. 3 and disassembled
from the longitudinally reciprocating carriage frame assembly in
FIG. 4. In FIG. 4, the right guide pin 82 is inserted proximally
through a right front pin guide 86 and then through a right rear
pin guide 88 both part of an upper frame 90 of the carriage frame
assembly 32. A proximal end of the right guide pin 82 resides
within a distally projecting right pin receptacle 92 (FIG. 12)
formed as part of a distal bulkhead 94 of the transmission section
31. A distal end of the right guide pin 82 is received by a right
pin recess 96 (FIG. 5) formed in the top cover 34. Similarly, the
left guide pin 84 is inserted proximally through a left front pin
guide 98 and then through a left rear pin guide 100, both part of
the upper frame 90 of the carriage frame assembly 32. A proximal
end of the left guide pin 84 resides within a distally projecting
left pin receptacle 102 respectively formed as part of the distal
bulkhead 94 of the transmission section 31. A distal end of the
left guide pin 84 is received by a left pin recess 104 (FIG. 5)
formed in the top cover 34.
With particular reference to FIGS. 3, 4, 6, 7 and 12, a right front
ring bearing 106 is inserted over a distal portion of the right
guide pin 82 and is received within a cylindrical recess 108 formed
on a distal side of the right front pin guide 86. A right aft ring
bearing 109 is inserted over a proximal portion of the right guide
pin 82 and is received within a cylindrical recess 111 (FIG. 6)
formed on a proximal side of the right aft pin guide 88. A left
front ring bearing 110 is inserted over a distal portion of the
left guide pin 84 and is received within a cylindrical recess 112
formed on a distal side of the left front pin guide 98. A left aft
ring bearing 113 (FIG. 9) is inserted over a proximal portion of
the left guide pin 84 and is received within a cylindrical recess
115 (FIG. 6) formed on a proximal side of the left aft pin guide
100. A right compression spring 114 is proximally received over the
right guide pin 82 between the right front and rear pin guides 86,
88. More particularly, the right compression spring 114 is distally
positioned against the right front pin guide 86 and at its proximal
end by a right downwardly projecting structure 116 (FIG. 5) formed
on an interior of the top cover 34 that closely encompasses a top
portion of the right guide pin 82 without contacting other portions
of the carriage frame assembly 32. A left compression spring 118 is
proximally received over the left guide pin 84 between the left
front and rear pin guides 98, 100. More particularly, the left
compression spring 118 is distally positioned against the left
front pin guide 98 at its distal end by a left downwardly
projecting structure 120 (FIG. 5) formed on the interior of the top
cover 34 that closely encompasses a top portion of the left guide
pin 84 without contacting other portions of the carriage frame
assembly 32. Thereby, the carriage frame assembly 32 is biased to a
distal position relative to the top cover 34 and lower handle tray
16.
In FIGS. 3-5, a forward projecting cylindrical resilient member 122
fastened to the upper frame 90 reduces noise by contacting the
front interior of the top cover 34 slowing distal movement of the
carriage frame assembly 32 prior to reaching full travel. The
distal bulkhead 94 is restrained by being proximal to a top ridge
123, a right ridge 125, and a left ridge 127 (FIG. 5) formed in the
interior of the top cover 34 and to a bottom ridge 129 formed on an
upper surface of the lower handle tray 16.
Returning to FIGS. 3-4 and 7, the upper frame 90 has right and left
front shaft apertures 124, 126 that respectfully receive for
rotation a distal end of a rotation shaft 128 and a translation
shaft 130. The right front shaft aperture 124 is closed by the
front portion of a right lower frame 131 of the carriage frame
assembly 32. The left front shaft aperture 126 is closed by the
front portion of a left lower frame 132 of the carriage frame
assembly 32. A front (cutter) carriage 134 and an aft (straw)
carriage 136 are received on the translation shaft 130 and are
encompassed by the upper and lower frames 90, 132. In FIG. 6, a
proximal beveled and slotted end 138 of the rotation shaft 128
extends out of right aft shaft aperture 140 formed in the upper
frame 90 for engagement to the transmission section 31 and is
closed by an aft portion of the lower frame 131. A proximal slotted
end 142 of the translation shaft 130 extends out of a left aft
aperture 144 formed in the upper frame 90 for engagement to the
transmission section 31 and closed by the lower frame 132. A
threaded receptacle 146 on the aft end of the upper frame 90
receives a proximally projecting bolt 148 having an upwardly
directed strike pin 148 at its proximal end.
In FIGS. 7-10, the carriage frame assembly 32 sequences translation
of the front and aft carriages 134, 136. With particular reference
to FIG. 10, the front and aft carriages 134, 136 respectively
include lower longitudinal grooves 152, 154 that slide upon a lower
rail 156 upwardly presented on the left lower frame 132. The front
and aft carriages 134, 136 respectively include an upper
longitudinal groove 158, 160 that slides upon a rail (not shown)
downwardly presented on the upper frame 90. The translation shaft
130 has a distal overrun portion 162 and a center overrun portion
164 separated by a front threaded portion 166 that a threaded bore
168 of a front main body portion 169 of the front carriage 134
traverses in response to rotation of the translation shaft 130. A
front translation compression spring 170 on the translation shaft
130 distal to the front carriage 134 compresses to allow the front
carriage 134 to free wheel when being distally advanced and then
biases the front carriage 134 aft to engage the front threaded
portion 166 for being retracted upon reversal of rotation of the
translation shaft 130.
With particular reference to FIGS. 8 and 10, proximal to the center
overrun portion 164 is an aft threaded portion 172 and then a
proximal overrun portion 174 that a threaded bore 176 of a back
main body portion 177 of the aft carriage 136 traverses in response
to rotation of the translation shaft 130 as well as in response to
a connection to the front carriage 134. In particular, a front
bracket 178 mounted on a right side of the front carriage 134 has a
rightward front pin guide 180 that receives a distal end of a
longitudinally aligned carriage limiting rod 182. A distal threaded
end 184 of the carriage limiting rod 182 extends distally out of
the rightward front pin guide 180 and is prevented from backing out
by a front nut 186. A long compression spring 188 is received over
a shaft 190 of the carriage limiting rod 182 proximal to the
rightward front pin guide 180. An aft bracket 192 is attached to a
right side of the back main body portion 177 of the aft carriage
136 to extend a rightward aft pin guide 194 that receives the
carriage limiting rod 182, which extends a proximal threaded end
196 proximally out of the rightward aft pin guide 194 to receive an
aft nut 198 that limits forward movement. The long compression
spring 188 biases the aft carriage 136 away from the front carriage
134, delaying retraction of a tissue sample until cutting is
complete when full distal translation of the front carriage 134
pulls the aft carriage 136 onto the aft threaded portion 172.
With particular reference to FIG. 9, a lengthwise engagement
aperture 200 defined between the right and left lower frames 131,
132 presents engaging structures that actuate the disposable probe
assembly 14 and the vacuum syringe assembly 18. The rotation (spur)
gear 128 exposes its left side to the lengthwise engagement
aperture 200 for engagement with the rotation spur gear section 68
of the cutter gear 62 to impart a rotation. The front bracket 178
has a downward distal half cylinder recess 202 sized to grip the
distal reduced diameter bearing surface 64 of the cutter gear 62
(FIG. 2). The front bracket 178 further has a downward proximal
half cylinder recess 204 proximally spaced and sized to grip the
proximal reduced diameter bearing surface 66 of the cutter gear 62
(FIG. 2) as well as a downwardly projecting front actuation finger
206 to the left side and below of the cutter gear 62 for selecting
vacuum from the vacuum syringe assembly 18. Similarly, the aft
bracket 192 has a downward distal half cylinder recess 208 and a
downward proximal half cylinder recess 210 proximally spaced and
sized to grip portions of the straw assembly 72 as applicable to
effect retraction of tissue samples, as well as a downwardly
projecting aft actuation finger 212 to the left side of the straw
assembly 72.
In FIGS. 2-3 and 11-12, the motor drive assembly 76 rotates
rotation and translation shafts 128, 130 at a fixed ratio to
optimize cutting performance of the cutter tube 36 when the slide
button 28 is back. Alternatively, the motor drive assembly 76
imparts a jackhammer vibration to the carriage frame assembly 32
when the slide button 28 is forward. With particular reference to
FIGS. 11-12, the planetary gearbox 78 extends proximally a keyed
motor drive shaft 214 (FIG. 12) through a drive shaft hole 216
formed in the distal bulkhead 94. A slide spur gear 218 is received
upon the keyed motor drive shaft 214 remaining engaged for rotation
between a first distal (jack hammer) position and a second proximal
(translation) position in accordance with a position of the slide
button 28 whose distal and proximal feet 220, 222 straddle the
slide spur gear 218. In FIG. 11, the slide spur gear 218 is close
to a proximal bulkhead 224 of the transmission section 31, engaging
a small spur 226 of a multiplier gear assembly 228. The multiplier
gear assembly 228 includes a longitudinal shaft 230 centrally
attached to the small spur gear 226. Proximal thereto, a
cylindrical hub 232 is pinned to the longitudinal shaft 230 and in
turn is encompassed by and pinned to a large spur gear 234 that
rotates within a correspondingly sized, distally open recess 236
formed in proximally projecting container 237 integral to the
proximal bulkhead 224. A front cylinder bearing 238 received on a
distal portion of the longitudinal shaft 230 is received by the
proximal surface of the distal bulkhead 94.
A first output drive shaft 240 distally presents a right angle
prismatic end 242 shaped to engage the beveled and slotted end 138
of the rotation shaft 128 that passes through a lower right hole
244 in the distal bulkhead 94. A cylindrical spacer 246 is received
over a distal cylindrical portion 248 of the first output shaft
240, taking up the space between the rotation shaft 128 and the
proximal bulkhead 224. A distally open recess 250, formed as part
of the container 237 that communicates from below with the recess
236, is shaped to receive a proximal cylindrical end 252 of the
first output drive shaft 240 and encompasses cylindrical bearing
254 as well as a small spur gear segment 256, which is distal
thereto and engages the large spur gear 234 of the multiplier gear
assembly 228.
A second output drive shaft 258 distally presents a right angle
prismatic end 260 to engage the proximal slotted end 142 of the
translation shaft 130 that extends through a low left hole 262 in
the distal bulkhead 94. A cylindrical spacer 264 is received over a
distal cylindrical portion 266 of the second output drive shaft 258
proximal to the right angle prismatic end 260 and distal to a wider
diameter hub segment 268 that is encompassed by and pinned to a
large spur gear 270 that engages the small spur gear 226 of the
multiplier gear assembly 228. Proximal to the hub segment 268 is a
wide spacer segment 272 and then a narrow cylindrical end 274 that
receives a cylindrical bearing 276 that resides within a
correspondingly-sized, distally open recess 278 that communicates
from the left with the recess 236 and is formed as part of the same
container 237.
The distal and proximal bulkheads 94, 224 are structurally attached
to one another in parallel alignment traverse to the longitudinal
axis of the biopsy device 10 by cylindrical legs 280 molded to and
proximally projecting from rectangular comers of the distal
bulkhead 94 and fastened to the proximal bulkhead 224. In addition,
a pin 282 passes through holes 281, 283 longitudinally aligned in
the distal and proximal bulkheads, 94, 224 respectively along a top
surface.
When the slide button 28 is moved distally to the jackhammer
position, the sliding spur gear 218 disengages from the small spur
gear 226 and engages a large spur gear 284 of a rotary camming gear
assembly 286. A camming shaft 286 from distal to proximal includes
a distal cylindrical end 288, a cam wheel 290, a mid-shaft portion
292 that receives the upwardly directed strike pin 150 of the
proximally projecting bolt 148, a wide diameter hub 294 that is
encompassed by and pinned to the large spur gear 284, and a
proximal cylindrical end 296. A distal cylindrical bearing 298 is
received within a proximally open container 300 projecting distally
from the distal bulkhead 94 and in turn receives the distal
cylindrical end 288 of the camming shaft 286. A proximal
cylindrical bearing 302 is received within a distally projecting
and open cylinder 304 formed on the proximal bulkhead 224 and in
turn receives the proximal cylindrical end 296 of the camming shaft
286.
As the camming shaft 286 rotates clockwise as viewed from behind,
the cam wheel 290 presents a proximal surface to the distal edge of
the strike pin 150 that is more proximal until the interrupted
portion of the camming wheel 290 is presented, allowing the strike
pin 150 to return to a distal position under the urging of the
distal biasing of the right and left compression springs 114,
118.
In FIGS. 13-22, the disposable probe assembly 14 has movable
components that respond to the actuating motions of the reusable
handpiece 12. With particular reference to FIGS. 13-17, the probe
support body 60 includes a distal probe mount 306 that is received
within the distal probe mount cover 50 of the bottom cover 48.
Proximal to and underlying a longitudinal axis of the disposable
probe assembly 14 defined by a probe guide hole 308 passing through
the distal probe mount 306, an upwardly open longitudinal trough
310 is formed into a necked portion 312 of the probe support body
60. At a proximal end of the longitudinal trough 310, an upper rod
passage 314 longitudinally passes through an upper portion of a
proximal block portion 316 of the probe support body 60. A distal
vacuum pump rod 317 is received for longitudinal movement in the
upper rod passage 314.
With particular reference to FIGS. 15, 18, a distal portion of the
upwardly open longitudinal trough 310 is also downwardly open. A
distally and proximally open, longitudinally aligned valve bore 318
is formed in a lower portion of the proximal block portion 316. A
proximal 90 degree fitting 319 seals a proximal opening of the
valve bore 318 to an upper end of the external conduit 42. Central
and proximal ports 320, 321 communicate with the valve bore 318
laterally from a left side of the proximal block portion 316 and a
distal port 322 communicates laterally from a left side of the
proximal block portion 316. A right distal 90-degree fitting 337
communicates between the distal port 322 and an intake filter 323
within an outer hose fitting 324.
A valve control rod 325 has a distal actuating portion 326
extending distally out of the valve bore 318 with a distal end
positionable under the downwardly open portion of the longitudinal
trough 310. The valve control rod 325 also has a valve spool
portion 327 that longitudinally translates within the valve bore
318 to selectively position between a first position and a second
position. A proximal O-ring 328 near a proximal end of the valve
spool portion 327 and a distal O-ring 329 are spaced such that the
first position entails the O-rings 328, 329 bracketing the central
and distal ports 320, 322 and the second position entails the
O-rings 328, 329 bracketing the proximal and central ports 321,
320, respectively.
In FIGS. 17-18, the distal vacuum conduit 330 has one end attached
to a center ninety-degree fitting 331 attached to the central port
320 and the other end attached to a probe union ninety-degree
fitting 332 that communicates with the lateral lumen 44. The vacuum
source conduit 74 has one end attached to a canister ninety degree
fitting 334 and the other attached to a proximal ninety degree
fitting 335 attached to the proximal port 321.
In FIGS. 15, 18, the front actuation finger 206 of the front
carriage 134 (FIG. 9) is received within an upwardly open socket
336 formed on a left side of a vacuum control shuttle 338 having a
lateral concave recessed band 340 shaped to encompass with a
clearance a lower portion of the rotation spur gear section 68 of
the cutter gear 62. The vacuum control shuttle 338 is laterally
sized to bridge the longitudinally open trough 310 with an L-shaped
connector 341 attached to an undersurface of the vacuum control
shuttle 338 sized to reside within the longitudinal trough 310 and
to extend its vertical and proximal portion below the longitudinal
trough 310 to attach to the distal end of the vacuum actuating
portion 326 of the valve control rod 325.
A straw holder 342 of the straw assembly 72 includes a distal
sleeve 344 with a leftward projection 346 near its distal end and
attached at its proximal left edge to an elongate splint member 348
having a midpoint indented feature 350 and attached along its
proximal rightward surface to a proximal sleeve 352. A straw 354 is
received through the proximal sleeve 352, to the right of the
elongate splint member 348, through the distal sleeve 344, and on
through a rear dynamic seal 356 attached to a proximal end of the
cutter gear 62, and into the cutter tube 36. A support plate 358
traversely fastened to an aft surface of the probe support body 60
has a downwardly open notch 360 that allows connection of the
proximal 90 degree fitting 319 and passage of the distal vacuum
pump rod 317. An upper guide hole 362 receives the proximal sleeve
352 of the straw holder 342.
A straw hook wire 364 keeps the straw assembly 72 in place upon the
probe support body 60 prior to engagement with the reusable
handpiece 12. A curled lower right end passes into leftwardly
opening 365 along the top right surface of the proximal block
portion 316 of the probe support body 60 into a small mounting
block 366 extending upwardly from a right side with a downwardly
inserted pin 368 passing through the curled lower right end to hold
the straw hook wire 364 in place. The straw hook wire 364 has a
horizontal portion attached to the curled end that passes under the
straw 354 and elongate splint member 348, bending upward within the
midpoint indented feature 350 and then bending leftward and
horizontally again through a lateral slot 370 in a vertical wire
support member 372 formed onto a left side of the top surface of
the proximal block. portion 316. It should be appreciated that
engagement of the reusable handpiece 12 forces the left portions of
the straw hook wire 364 out of engagement with the midpoint
indented feature 350 as a rib feature 373 (FIG. 9) deflects the
left portion of the straw hook wire 364. Thus, translation of the
aft carriage 136 may cause translation of the straw assembly
72.
With further reference to FIG. 15, proximal to the vacuum as
control shuttle 338, a vacuum pump shuttle 374 is also laterally
sized to bridge the longitudinal trough 310 with an integral lower
central portion sized to reside within the longitudinal trough 310
and to attach to a distal end of the vacuum pump rod 317. A
backward projecting locking arm 376 attached to a left side of the
vacuum pump shuttle 374 has an inward proximal hook 378 that is
resiliently inwardly biased. The top extension member 59 has an aft
horizontal surface 382 sized to overlay a distal canister support
structure 384 (FIG. 16) attached to an upper canister portion 386
(FIG. 16) of the vacuum syringe assembly 18. The top extension
member 59 also has a right horizontal surface 386 and a left
horizontal surface 388 extending forward from the distal corners of
the aft horizontal surface 382 that surround the top surface of the
probe support body 60 covering the gap to the top edges of the
bottom cover 48. Right and left legs 390, 392 extend downward with
inwardly curled edges at the juncture respectively between the
right horizontal surface 386 and aft horizontal surface 382 and the
juncture between the left horizontal surface 388 and the aft
horizontal surface 382. Along an inner surface of the left
horizontal surface 388, a kick-out ridge 394 extends upwardly,
longitudinally positioned to coincide with full distal travel of
the vacuum pump shuttle 374, which coincides with an initial
condition of the disposable probe assembly 14 with the straw
assembly 72 locked forward by the straw hook wire 364 and the side
aperture 20 of the probe cannula 22 closed by the cutter tube
36.
With particular reference to FIG. 16, the vacuum syringe assembly
18 is configured to respond to longitudinal translation of the
distal vacuum pump rod 317. In particular, the canister support
structure 384 includes a right rail bracket 396 and a left rail
bracket 398, joined at their proximal ends to one another and to an
upper portion of a distal circular face 400 of the upper canister
portion 386 with a distally and vertically open longitudinal guide
slot 402 defined between the rail brackets 396, 398. A connection
block 404 with a transverse cross section similar to a cloverleaf
with a narrowed upper lobe translates between the distal circular
face 400 and right and left down-turned mounting surfaces 406, 408
of the right and left rail brackets 396, 398 respectively that are
attached to the aft surface of the probe support body 60.
An upper narrowed projection 410 of the connection block 404 is
fastened to a proximal end of the distal vacuum pump rod 317 (FIG.
18) and shaped to slide within the guide slot 402. A hole 412
centered on the distal circular face 400 is aligned with a small
lower protuberance 414 of the connection block 404. A proximal
vacuum pump rod 416 is attached to a proximal side of the small
lower protuberance 414 and passes through the hole 412 and on
through a dynamic O-ring seal 418 within a neck 420 of a seal cup
422 that is fastened to the proximal side of the distal circular
face 400 of the upper canister portion 386. The proximal end of the
proximal vacuum pump rod 416 passes on through a vacuum pump
cylinder 424 whose bottle neck 426 and distal portion fits within
the seal cup 422. Lateral sides of the vacuum pump cylinder 424 are
closely encompassed by fastening together the upper container
portion 386 to a lower canister portion 428 with a proximal
circular opening closed by a canister end cap. 430 (FIG. 2).
With particular reference to FIGS. 16 and 18, a proximal end of the
proximal vacuum pump rod 416 passes through a central hole 431 in a
tension plunger seal 432, partially through an enlarged distal
central hole 433 in a tension plunger body 434 that proximally
communicates with a smaller proximal central hole 435 too small for
the proximal vacuum pump rod 416. A washer 436, centered on a
proximal face of the tension plunger body 434, is held on by a
small bolt 438 that passes distally into the smaller proximal
central hole 435 and is threaded into the proximal vacuum pump rod
416. The canister ninety-degree fitting 334 passes through a bottom
hole 440 in the lower canister portion 428. With particular
reference to FIG. 18, an O-ring 442 between the lower canister
portion 428 and the vacuum pump cylinder 424 form a static seal
between the bottom hole 440 and an aligned distal bottom hole 446
to communicate with a variable volume vacuum cavity 448 whose
volume is dictated by the longitudinal position of a syringe
plunger assembly 450 formed by the combination of the tension
plunger seal and body 432, 434.
In use, in FIG. 18, the disposable biopsy assembly 14 is in an
initial condition with the cutter gear 62 distally positioned,
which closes the side aperture 20 in the probe cannula 22 for
insertion (FIG. 19). In addition, the underlying vacuum control
shuttle 338 is at its distal position, moving the valve control rod
325 distally to the first position with the atmospheric air made
available through the distal port 322 to the central port 320 to
the lateral lumen 44 of the probe cannula 22. The vacuum pump
shuttle 374 is distally positioned behind the vacuum control
shuttle 338 in its most distal position drawing distally the distal
vacuum pump rod 317, connection block 404, proximal vacuum pump rod
416, and finally the vacuum syringe plunger 450 to an unactuated
state. In addition, the straw assembly 72 is also distally advanced
with the straw 354 inserted through the cutter tube 36.
In FIG. 19, the reusable handpiece 12 is mounted onto the
disposable probe assembly 14 in the same state as FIG. 18. The
front (cutter) carriage 134 of the reusable handpiece 12 engages
the cutter gear 62 for longitudinal movement, as well as extending
downwardly projecting front actuation finger 206 into engagement
with the upwardly open socket 336 of the vacuum control shuttle
338. The aft (straw) carriage 136 of the reusable handpiece 12
engages the straw assembly 72 for longitudinal movement, as
presenting the downwardly projecting aft actuation finger 212 to
leftward projection 346 of the straw assembly 72. With the biopsy
device 10 thus prepared, the piercing tip 26 is inserted into
tissue with the side aperture 20 placed beside a suspicious lesion
452.
In FIG. 20, the reusable handpiece 12 prepares the disposable probe
assembly 14 by rotating the translation shaft 130 in the direction
that retracts the aft carriage 136 whose threaded bore 176 is
engaged to the aft threaded portion 172 while the front carriage
134 free wheels on the distal overrun portion 162, which causes the
straw 354 to retract within the cutter tube 36. As the aft carriage
136 approaches its proximal most position, the aft carriage 136
reaches the full travel of the carriage limiting rod 182, which
thus pulls the threaded bore 168 of the front carriage 134 onto the
front threaded portion 166, overcoming the bias of the long
compression spring 188 on the carriage limiting rod 182.
In FIG. 21, continued rotation of the translation shaft 130 with
the aft carriage 136 free wheeling on the proximal overrun portion
174 causes the front carriage 134 to retract to the center overrun
portion 164 and freewheel, while proximally moving the vacuum
control shuttle 338 and thus moving the vacuum control rod 325
proximally to the second position with the lateral lumen 44
communicating through the central port 320 to the proximal port 321
to the variable volume vacuum cavity 448 of the vacuum syringe
assembly 18 which increases in volume as the vacuum pump shuttle
374 is driven aft by the vacuum control shuttle 338. A sample
indicator (not shown) located within the straw assembly 72 closes
the lumen within the straw 354, resulting in a low pressure
("vacuum") as compared to atmospheric pressure within the lateral
lumen 44. This low pressure is presented to the side aperture 20 as
the cutter tube 36 retracts, passing through internal holes 453
passing between the lateral and cutter lumens 44, 46 beneath the
side aperture 20, prolapsing a portion of the suspicious lesion 452
into the cutter lumen 46. The backward projecting locking arm 376
of the vacuum pump shuttle 374 engages the downwardly projecting
aft actuation finger 212 of the aft carriage 136.
In FIG. 22, with the vacuum pump shuttle 374 thus held to keep
vacuum assistance available, the front carriage 134 is distally
translated by rotation of the translation shaft 130 in the opposite
direction. In particular, the long compression spring 188 on the
carriage limiting rod 182 urges the threaded bore 168 of the front
carriage 134 into engagement with the front threaded portion 166
while the bias from the long compression spring 188 also biases the
aft carriage 136 to remain free wheeling on the proximal overrun
portion 174. Although not shown in FIG. 22, it should be
appreciated that the rotation shaft 128 is rotating the cutter gear
62 and thus the cutter tube 36 in a ratio related to the rate of
translation. When the front carriage 134 reaches full distal
travel, the vacuum control shuttle 338 switches the vacuum control
rod 325 to the first position that vents the lateral lumen 44 to
the atmosphere while the straw assembly 72 maintains a residual
vacuum behind a severed tissue sample 454 in the cutter lumen 46.
The differential pressure on the sample 454 assists in retracting
the sample 454. In particular, as the carriage limiting rod 182
reaches full separation between the carriages 134, 136, the aft
carriage 136 is drawn onto the aft threaded portion 172 to distally
translate both the vacuum pump shuttle 374 and the straw assembly
72 so that the straw 354 encompasses the severed tissue sample 454
with the biopsy device 10 returned to the position of FIG. 19.
Operation as described for FIG. 20 retracts the sample 454
preparing the device for repositioning as desired and the taking of
another core biopsy sample.
It should be appreciated that any patent, publication, or other
disclosure material, in whole or in part, that is said to be
incorporated by reference herein is incorporated herein only to the
extent that the incorporated material does not conflict with
existing definitions, statements, or other disclosure material set
forth in this disclosure. As such, and to the extent necessary, the
disclosure as explicitly set forth herein supersedes any
conflicting material incorporated herein by reference. Any
material, or portion thereof, that is said to be incorporated by
reference herein, but which conflicts with existing definitions,
statements, or other disclosure material set forth herein, will
only be incorporated to the extent that no conflict arises between
that incorporated material and the existing disclosure
material.
While preferred embodiments of the present invention have been
shown and described herein, it will be obvious to those skilled in
the art, given the benefit of the present disclosure, 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 spirit and scope of
the appended claims.
While advantageous sequencing allows vacuum to be stored and used
in relation to two carriages, applications consistent with the
present invention may include other operable coupling of a motor
contained in a hand-held proximal portion of a biopsy device, such
as coupling the motor to turn a vacuum pump that evacuates a fixed
volume vacuum accumulator. As another example, the motor may wind
up a reel that positions a plunger of a vacuum syringe.
As another example, for imaging modalities such as magnetic
resonance imaging (MRI), the power supplies, control circuitry and
motor may be selected from technologies that are inherently immune
to a strong magnetic field and/or shielded to avoid transmission of
radio frequency (RF) interference that may create artifacts in the
diagnostic images. Alternatively or in addition, certain components
may be remote to the hand-held device such as the DC motor
connected by a mechanical drive cable.
As yet another example, instead of segregating the vacuum syringe
assembly to the disposable probe assembly, a vacuum container that
is evacuated or otherwise causes to contain a low pressure by a
motor-driven mechanism may be part of a reusable handpiece
pneumatic conduits that communicate to a probe assembly.
* * * * *