U.S. patent application number 10/936395 was filed with the patent office on 2005-05-26 for biopsy apparatus.
Invention is credited to Butcher, Charles, Hancock, John P., Mark, Joseph L., Miller, Michael E., Schwindt, Jeffrey.
Application Number | 20050113715 10/936395 |
Document ID | / |
Family ID | 27107810 |
Filed Date | 2005-05-26 |
United States Patent
Application |
20050113715 |
Kind Code |
A1 |
Schwindt, Jeffrey ; et
al. |
May 26, 2005 |
Biopsy apparatus
Abstract
A disposable tissue removal device comprises a "tube within a
tube" cutting element mounted to a handpiece. The inner cannula of
the cutting element defines an inner lumen and terminates in an
inwardly beveled, razor-sharp cutting edge. The inner cannula is
driven by both a pneumatic rotary motor and a pneumatic
reciprocating motor. At the end of its stroke, the inner cannula
makes contact with the cutting board to completely sever the
tissue. An aspiration vacuum is applied to the inner lumen to
aspirate excised tissue through the inner cannula and into a
collection trap removably mounted to the handpiece. The rotary and
reciprocating motors are hydraulically or pneumatically powered
through a foot pedal operated pneumatically circuit. In one
embodiment, the cutting element includes a cannula hub that can be
connected to a fluid source, such as a valve-controlled saline
bag.
Inventors: |
Schwindt, Jeffrey;
(Indianapolis, IN) ; Miller, Michael E.;
(Trafalgar, IN) ; Mark, Joseph L.; (Indianapolis,
IN) ; Hancock, John P.; (Fishers, IN) ;
Butcher, Charles; (Carmel, IN) |
Correspondence
Address: |
BARNES & THORNBURG
11 SOUTH MERIDIAN
INDIANAPOLIS
IN
46204
|
Family ID: |
27107810 |
Appl. No.: |
10/936395 |
Filed: |
September 8, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10936395 |
Sep 8, 2004 |
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10639569 |
Aug 12, 2003 |
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10639569 |
Aug 12, 2003 |
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09864031 |
May 23, 2001 |
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6638235 |
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09864031 |
May 23, 2001 |
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09707022 |
Nov 6, 2000 |
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6758824 |
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Current U.S.
Class: |
600/566 ;
600/564; 600/567; 606/167 |
Current CPC
Class: |
A61B 2017/00973
20130101; A61B 10/0275 20130101; A61B 10/0283 20130101; A61B
2217/007 20130101; A61B 2010/0208 20130101; A61B 2217/005 20130101;
A61B 10/025 20130101 |
Class at
Publication: |
600/566 ;
600/564; 600/567; 606/167 |
International
Class: |
A61B 010/00 |
Claims
What is claimed:
1. A tissue cutting device comprising: an outer cannula defining an
outer lumen and a tissue-receiving opening adjacent a distal end of
said outer cannula communicating with said outer lumen; an inner
cannula slidably disposed within said outer lumen and defining a
inner lumen from an open distal end to an open opposite proximal
end, said inner cannula defining a cutting edge at said open distal
end operable to sever tissue projecting through said tissue
receiving opening; a first hydraulic rotary motor operably coupled
to said inner cannula to rotate said inner cannula within said
outer cannula; a second hydraulic reciprocating motor operably
coupled to said inner cannula to translate said inner cannula
within said outer cannula while said inner cannula rotates; and a
hydraulic system connecting said first and second hydraulic motors
to a source of pressurized fluid.
2. The tissue cutting device of claim 1 further comprising a
cutting board disposed at said distal end of said outer
cannula.
3. The tissue cutting device of claim 2 wherein said cutting board
is formed of a resilient plastic material having a hardness less
than a hardness of said inner cannula at said cutting edge, but
sufficient to substantially prevent permanent deformation of said
cutting board under pressure from said cutting edge as said inner
cannula rotates and reciprocates against said cutting board.
4. The tissue cutting device of claim 1 wherein said cutting edge
is an inwardly beveled surface.
5. The tissue cutting device of claim 4 further comprising a dimple
in an inner surface of said outer cannula immediately proximal to
said tissue-receiving opening, said dimple sized to fit between
said inner cannula and said outer cannula.
6. The tissue cutting device of claim 1 further comprising a
handpiece removably engageable to said outer cannula and supporting
said inner cannula, said first hydraulic rotary motor, and said
second hydraulic reciprocating motor.
7. The tissue cutting device of claim 6 further comprising a
collection trap removably mountable to said handpiece and in
communication with said proximal end of said inner lumen.
8. The tissue cutting device of claim 7 wherein said collection
trap includes a filter element disposed within said collection
trap.
9. The tissue cutting device of claim 7 further comprising a vacuum
source in fluid communication with said collection trap to aspirate
tissue through said inner lumen into said collection trap.
10. The tissue cutting device of claim 6 further comprising a cover
removably engageable to and enclosing said handpiece.
11. The tissue cutting device of claim 10 wherein said cover
includes: at least one tang projecting inwardly from an inner
surface thereof; and said handpiece defines at least one engagement
notch configured for receiving a corresponding one of said at least
one tang for engaging said cover to said handpiece.
12. The tissue cutting device of claim 1 wherein said outer cannula
further includes a stiffening element along a length thereof for
increasing a bending resistance of said outer cannula.
13. The tissue cutting device of claim 12 wherein said stiffening
element includes a longitudinally extending rib defined in an outer
surface of said outer cannula.
14. The tissue cutting device of claim 13 wherein said rib includes
a bead adhered to a surface of said outer cannula.
15. The tissue cutting device of claim 13 wherein said rib includes
a crimp in said outer cannula.
16. The tissue cutting device of claim 12 wherein said stiffening
element is substantially diametrically opposite the
tissue-receiving opening.
17. The tissue cutting device of claim 12 wherein said stiffening
element includes a layer of rigid material bonded to a surface of
said outer cannula.
18. The tissue cutting device of claim 17 wherein said material is
stainless steel.
19. The tissue cutting device of claim 1 further comprising a
vacuum source in fluid communication with said inner lumen at said
proximal end of said inner cannula to aspirate tissue through said
inner lumen.
20. The tissue cutting device of claim 1 further comprising: an
irrigation lumen in fluid communication with said outer lumen; and
a source of irrigation fluid in communication with said irrigation
lumen.
21. The tissue cutting device of claim 20 wherein said source of
fluid includes an anesthetic fluid.
22. The tissue cutting device of claim 1 further comprising a
dimple in an inner surface of said outer cannula immediately
proximal to said tissue-receiving opening, said dimple sized to fit
between said inner cannula and said outer cannula.
23. The tissue cutting device of claim 1 wherein said
tissue-receiving opening includes a pair of opposite sides
extending longitudinally along said outer cannula, at least one of
said opposite sides defining at least one tooth arranged to engage
tissue drawn into said opening when said cannula is inserted into a
body.
24. The tissue cutting device of claim 23 wherein at least one of
said opposite sides defines a plurality of teeth, said teeth angled
proximally away from said distal end of said outer cannula.
25. The tissue cutting device of claim 23 wherein each of said
opposite sides defines a plurality of teeth, said teeth angle
proximally away from said distal end of said outer cannula.
26. The tissue cutting device of claim 1 further comprising a
trocar tip having an engagement hub configured to fit tightly
within said distal end of said outer cannula.
27. The tissue cutting device of claim 26 further comprising a
cutting board disposed within said outer lumen affixed to said
engagement hub.
28. The tissue cutting device of claim 1 further comprising: a
tubular axle having a distal end and a proximal end; and a coupler
connecting said distal end of said tubular axle to said proximal
end of said inner cannula, wherein said first hydraulic rotary
motor is coupled to said tubular axle to rotate said axle and said
inner cannula therewith.
29. The tissue cutting device of claim 28 wherein said first
hydraulic rotary motor includes: a motor housing having opposite
ends and defining a pilot port in fluid communication with said
hydraulic system to receive said pressurized fluid; a rotor
rotatably disposed within said housing and connected to said axle
extending through said housing; and bearing surfaces at said
opposite ends of said housing for rotatably supporting said
axle.
30. The tissue cutting device of claim 29 wherein said second
hydraulic reciprocating motor includes: a hydraulic cylinder having
a second pilot port in fluid communication with said hydraulic
system to receive said pressurized fluid; a piston slidably
disposed within said cylinder; and a hollow tube in fluid
communication with said proximal end of said tubular axle, said
tube engaged to said piston and operably coupled to said first
hydraulic rotary motor to move said first hydraulic rotary motor as
said piston slides within said cylinder.
31. The tissue cutting device of claim 30 wherein said second
hydraulic reciprocating motor further includes: a return spring
disposed within said cylinder and biased against said piston to
move said piston, said housing and said inner cannula in a
direction away from distal end of said outer cannula.
32. The tissue cutting device of claim 31 further comprising: a
collection trap in fluid communication with said hollow tube; and a
vacuum source in fluid communication with said collection trap to
aspirate tissue through said inner lumen, said hollow axle and said
tube into said collection trap.
33. The tissue cutting device of claim 1 wherein said second
hydraulic reciprocating motor includes: a hydraulic cylinder having
a pilot port in fluid connection with said hydraulic system to
receive said pressurized fluid; a piston disposed within said
cylinder and operably coupled to said inner cannula to move said
inner cannula within said outer cannula toward said distal end of
said outer cannula; a return spring disposed within said cylinder
and biased against said piston to move said piston and said inner
cannula within said outer cannula in a direction away from distal
end of said outer cannula.
34. The tissue cutting device of claim 1, wherein said hydraulic
system includes: a manual switch disposed between an output line
and said source of pressurized fluid, said manual switch operable
in a first position to connect said output line to said source, and
in a second position to disconnect said output line from said
source; a first pressure actuated switch disposed between said
source of pressurized fluid and said first motor, said first switch
operable in response to fluid pressure in said output line to
connect or disconnect said first motor to/from said source; and a
second pressure actuated switch disposed between said source of
pressurized fluid and said second motor, said second switch
operable in response to fluid pressure in said output line to
connect or disconnect said second motor to/from said source.
35. The tissue cutting device of claim 34, wherein said hydraulic
system includes a vacuum source.
36. The tissue cutting device of claim 35, wherein: said vacuum
source includes a venturi device; and said hydraulic system
includes a third pressure actuated switch disposed between said
source of pressurized fluid and said venturi device, and third
switch operable in response to fluid pressure in said output line
to connect or disconnect said venturi device to/from said
source.
37. The tissue cutting device of claim 34, wherein: said second
hydraulic motor includes a hydraulic cylinder having a piston
operably coupled to said inner cannula, a hydraulic input connected
to said second pressure actuated switch and a return spring
disposed within said cylinder and operating on said piston against
fluid pressure at said hydraulic input; and said hydraulic system
further includes an oscillating switch disposed between said output
line and said second pressure actuated switch, said oscillating
switch operable in response to fluid pressure in said hydraulic
cylinder to connect or disconnect said hydraulic input to/from said
second pressure actuated switch.
38. A tissue cutting device comprising: an elongated handpiece
defining an elongated channel on an outer surface of said
handpiece; a cannula hub mounted to said handpiece and having a
fluid port; a tube connected at one end to said fluid port and
having an opposite end connectable to a fluid source, said tube
disposed within said elongated channel and sized to be recessed
within said channel relative to said outer surface an outer cannula
supported at a proximal end by said cannula hub and defining a
tissue-receiving opening adjacent a distal end thereof, and a lumen
between said proximal and distal ends in fluid communication with
said fluid port of said cannula hub; and an inner cutting member
slidably disposed within said lumen of said outer cannula and
defining a cutting edge at said distal end operable to sever tissue
projecting through said tissue-receiving opening.
39. The tissue cutting device of claim 38, further comprising a
fluid source connected to said opposite end of said tube, said
fluid source including: a container holding a supply of a fluid;
and a valve between said container and said fluid port and operable
to control the flow of fluid from said container through said
tube.
40. The tissue cutting device of claim 39, wherein said valve is a
pinch valve engaged about said tube.
41. A method for performing a tissue biopsy at a sample site within
a patient comprising the steps of: introducing an outer cannula
into the patient with a tissue receiving opening adjacent the
sample site; providing a medical treatment through the outer
cannula at the sample site; connecting the outer cannula to a
tissue biopsy handpiece having a pneumatic motor-driven tissue
cutting cannula with the tissue cutting cannula extending into the
outer cannula; operating the tissue biopsy handpiece to excise
tissue through the tissue receiving opening; and storing the
excised tissue for subsequent examination.
42. A tissue cutting device for removing tissue from a patient
comprising: an outer cannula configured for introduction into the
patient and defining a tissue-receiving opening adjacent a distal
end thereof; an inner cannula slidably disposed within said outer
cannula and defining a lumen from an open distal end to an open
opposite end, said inner cannula further defining a cutting edge at
said open distal end operable to sever tissue projecting through
said tissue-receiving opening; a pneumatic motor assembly operably
coupled to said inner cannula to rotate and reciprocate said inner
cannula within said outer cannula; a vacuum source fluidly coupled
to said inner cannula for generating a vacuum in said lumen of said
inner cannula to draw severed tissue therethrough; and a tissue
collection chamber interposed between said vacuum source and said
open opposite end of said inner cannula to receive severed tissue
drawn into said chamber by the vacuum.
43. The tissue cutting device of claim 42, wherein said tissue
collection chamber includes a filter permitting passage of fluid
therethrough while retaining the severed tissue within said
chamber.
44. The tissue cutting device of claim 42 further comprising a
pneumatic control circuit having a vacuum switch, the vacuum switch
being configured to sense changes in vacuum in order to indicate
whether the severed tissue has been drawn completely into said
chamber.
45. The tissue cutting device of claim 44 wherein the pneumatic
circuit further comprises a pressure switch, the pressure switch
being configured to sense an end of stroke condition as indicated
by an increased backpressure.
46. The tissue cutting device of claim 45 wherein the inner cannula
advances through the tissue to be severed at a speed that is
proportional to the tissue's density.
47. A tissue cutting device comprising: an outer cannula defining a
tissue-receiving opening adjacent a distal end thereof; an inner
cannula slidably disposed within said outer cannula and defining a
lumen from an open distal end to an open opposite proximal end,
said inner cannula defining a cutting edge at said open distal end
operable to sever tissue projecting through said tissue-receiving
opening; a pneumatic rotary motor operably coupled to said inner
cannula to rotate said inner cannula within said outer cannula; a
pneumatic reciprocating motor operably coupled to said pneumatic
rotary motor to translate said rotary motor and thereby translate
said inner cannula within said outer cannula while said inner
cannula rotates; and a handpiece supporting said pneumatic rotary
motor and said pneumatic reciprocating motor, said handpiece
including a pair of opposite rails, wherein said pneumatic rotary
motor includes a pair of opposite outwardly projecting wings
configured to be slidably supported on said opposite rails to
resist rotation of said pneumatic rotary motor while permitting
said pneumatic rotary motor to translate relative to said
rails.
48. The tissue cutting device of claim 47 further comprising a
pneumatic control circuit having a vacuum switch, the vacuum switch
being configured to sense changes in vacuum in order to indicate
whether the severed tissue has been drawn completely into said
chamber.
49. The tissue cutting device of claim 48 wherein the pneumatic
circuit further comprises a pressure switch, the pressure switch
being configured to sense an end of stroke condition as indicated
by an increased backpressure.
50. The tissue cutting device of claim 49 wherein the inner cannula
advances through the tissue to be severed at a speed that is
proportional to the tissue's density.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 10/639,569 filed on Aug. 12, 2003, which is a
division of U.S. patent application Ser. No. 09/864,031, filed on
May 23, 2001, now U.S. Pat. No. 6,638,235, which in turn is a
continuation-in-part of U.S. patent application Ser. No. 09/707,022
filed on Nov. 6, 2000, now U.S. Pat. No. 6,758,824.
FIELD OF THE INVENTION
[0002] This invention relates to biopsy instruments and methods for
taking a biopsy. More specifically, this invention relates to
disposable biopsy devices for removing several tissue samples using
a single insertion.
BACKGROUND OF THE INVENTION
[0003] In the diagnosis and treatment of breast cancer, it is often
necessary to remove multiple tissue samples from a suspicious mass.
The suspicious mass is typically discovered during a preliminary
examination involving visual examination, palpitation, X-ray, MRI,
ultrasound imaging or other detection means. When this preliminary
examination reveals a suspicious mass, the mass must be evaluated
by taking a biopsy in order to determine whether the mass is
malignant or benign. Early diagnosis of breast cancer, as well as
other forms of cancer, can prevent the spread of cancerous cells to
other parts of the body and ultimately prevent fatal results.
[0004] A biopsy can be performed by either an open procedure or a
percutaneous method. The open surgical biopsy procedure first
requires localization of the lesion by insertion of a wire loop,
while using visualization technique, such as X-ray or ultrasound.
Next, the patient is taken to a surgical room where a large
incision is made in the breast, and the tissue surrounding the wire
loop is removed. This procedure causes significant trauma to the
breast tissue, often leaving disfiguring results and requiring
considerable recovery time for the patient. This is often a
deterrent to patients receiving the medical care they require. The
open technique, as compared to the percutaneous method, presents
increased risk of infection and bleeding at the sample site. Due to
these disadvantages, percutaneous methods are often preferred.
[0005] Percutaneous biopsies have been performed using either Fine
Needle Aspiration or core biopsy in conjunction with real-time
visualization techniques, such as ultrasound or mammography
(X-ray). Fine Needle Aspiration involves the removal of a small
number of cells using an aspiration needle. A smear of the cells is
then analyzed using cytology techniques. Although Fine Needle
Aspiration is less intrusive, only a small amount of cells are
available for analysis. In addition, this method does not provide
for a pathological assessment of the tissue, which can provide a
more complete assessment of the stage of the cancer, if found. In
contrast, in core biopsy a larger fragment of tissue can be removed
without destroying the structure of the tissue. Consequently, core
biopsy samples can be analyzed using a more comprehensive histology
technique, which indicates the stage of the cancer. In the case of
small lesions, the entire mass may be removed using the core biopsy
method. For these reasons core biopsy is preferred, and there has
been a trend towards the core biopsy method, so that a more
detailed picture can be constructed by pathology of the disease's
progress and type.
[0006] The first core biopsy devices were of the spring advanced,
"Tru-Cut" style consisting of a hollow tube with a sharpened edge
that was inserted into the breast to obtain a plug of tissue. This
device presented several disadvantages. First, the device would
sometimes fail to remove a sample, therefore, requiring additional
insertions. This was generally due to tissue failing to prolapse
into the sampling notch. Secondly, the device had to be inserted
and withdrawn to obtain each sample, therefore, requiring several
insertions in order to acquire sufficient tissue for pathology.
[0007] The biopsy apparatus disclosed in U.S. Pat. No. 5,526,822 to
Burbank, et al was designed in an attempt to solve many of these
disadvantages. The Burbank apparatus is a biopsy device that
requires only a single insertion into the biopsy site to remove
multiple tissue samples. The device incorporates a tube within a
tube design that includes an outer piercing needle having a
sharpened distal end for piercing the tissue. The outer needle has
a lateral opening forming a tissue receiving port. The device has
an inner cannula slidingly disposed within the outer cannula, and
which serves to cut tissue that has prolapsed into the tissue
receiving port. Additionally, a vacuum is used to draw the tissue
into the tissue receiving port.
[0008] Vacuum assisted core biopsy devices, such as the Burbank
apparatus, are available in handheld (for use with ultrasound) and
stereotactic (for use with X-ray) versions. Stereotactic devices
are mounted to a stereotactic unit that locates the lesion and
positions the needle for insertion. In preparation for a biopsy
using a stereotactic device, the patient lies face down on a table,
and the breast protrudes from an opening in the table. The breast
is then compressed and immobilized by two mammography plates. The
mammography plates create images that are communicated in real-time
to the stereotactic unit. The stereotactic unit then signals the
biopsy device and positions the device for insertion into the
lesion by the operator.
[0009] In contrast, when using the handheld model, the breast is
not immobilized. Rather the patient lies on her back and the doctor
uses an ultrasound device to locate the lesion. The doctor must
then simultaneously operate the handheld biopsy device and the
ultrasound device.
[0010] Although the Burbank device presents an advancement in the
field of biopsy devices, several disadvantages remain and further
improvements are needed. For example, the inner cutter must be
advanced manually, meaning the surgeon manually moves the cutter
back and forth by lateral movement of a knob mounted on the outside
of the instrument or by one of the three pedals at the footswitch.
Also, the vacuum source that draws the tissue into the receiving
port is typically supplied via a vacuum chamber attached to the
outer cannula. The vacuum chamber defines at least one, usually
multiple, communicating holes between the chamber and the outer
cannula. These small holes often become clogged with blood and
bodily fluids. The fluids occlude the holes and prevent the
aspiration from drawing the tissue into the receiving port. This
ultimately prevents a core from being obtained, a condition called
a "dry tap."
[0011] In addition, many of the components of the current biopsy
devices are reusable, such as the driver portions, which control
the outer and inner needles. This poses several notable
disadvantages. First, the reusable portion must be cleaned and/or
sterilized. This increases the time necessary to wrap up the
procedure, which ultimately affects the cost of the procedure. In
addition, the required clean-up and/or sterilization of reusable
parts increases the staffs' potential exposure to body tissues and
fluids. Finally, the reusable handle is heavy, large and cumbersome
for handheld use.
[0012] A further disadvantage is that current biopsy devices
comprise an open system where the tissue discharge port is simply
an open area of the device. A surgical assistant must remove the
tissue from the open compartment using forceps and place the tissue
on a sample plate. This ritual must be followed for every sample
and, therefore, multiple operators are required. In addition, the
open system increases the exposure to potentially infectious
materials, and requires increased handling of the sample. As a
practical matter, the open system also substantially increases the
clean-up time and exposure, because a significant amount of blood
and bodily fluid leaks from the device onto the floor and
underlying equipment.
[0013] Additionally, when using the current biopsy devices,
physicians have encountered significant difficulties severing the
tissue. For instance, the inner cutter often fails to completely
sever the tissue. When the inner cutting needle is withdrawn, no
tissue sample is present (dry tap), and therefore, reinsertion is
required. In the case of the Burbank apparatus, the failure to
completely sever the tissue after the first advancement of the
inner cutter results in a necessary second advancement of the inner
cutter. In this event, the procedure is prolonged, which is
significant because the amount of trauma to the tissue and,
ultimately, to the patient is greatly affected by the length of the
procedure. Therefore, it is in the patient's best interest to
minimize the length of the procedure by making each and every
attempt at cutting the tissue a successful and complete cut.
[0014] Additionally, when using the "tube within a tube" type
biopsy device, the inner cutter can lift up into the tissue
receiving opening during cutting. This lifting causes the inner
cutter to catch on the edge of the tissue receiving opening, which
ultimately results in an incomplete cut and dulling of the blade,
rendering the blade useless.
[0015] Also, prior devices often produce small tissue samples. As
the inner cutter advances, the cutting edge not only starts to
sever the tissue, it also pushes the tissue in front of the cutter.
This results in a tissue sample that is smaller than the amount of
tissue drawn into the tissue receiving opening.
[0016] An additional disadvantage of the prior devices is presented
by the complexity of the three-pedal footswitch. Prior devices
utilized a three-pedal footswitch; one pedal for advancing the
inner cannula, another pedal for retracting the inner cannula, and
a third pedal for turning on the aspiration. Operation of the three
pedals is difficult and awkward.
[0017] These disadvantages become even more significant when using
the handheld biopsy device. For instance, the physician must
operate the biopsy device and the ultrasound probe simultaneously
making it particularly difficult to manually advance of the inner
cutter. In addition, when an assistant is required to remove each
sample from the open discharge port, use of the handheld device
becomes even more awkward. Due to these disadvantages, many
physicians have declined to use the handheld models.
[0018] This is unfortunate because, some lesions that can signify
the possible presence of cancer cannot be seen using the
stereotactic unit. In these cases, the doctor must resort to either
the handheld device or open surgical biopsy. Due to the
difficulties associated with the handheld device, doctors often
choose the open surgical biopsy, which is particularly unfortunate
because a majority of the lesions that cannot be seen using the
stereotactic unit turn out to be benign. This means that the
patient has unnecessarily endured a significant amount of pain and
discomfort; not to mention extended recovery time and disfiguring
results. In addition, the patient has likely incurred a greater
financial expense because the open surgical technique is more
difficult, time consuming and costly, especially for those patient
without health insurance.
[0019] The disadvantages of the open surgical technique coupled
with the odds that the lesion is benign present a disincentive for
the patient to consent to the biopsy. The added discomfort alone is
enough to cause many patients to take the risk that the lesion is
benign. The acceptance of this risk can prove to be fatal for the
minority of cases where the lesion is malignant.
[0020] Finally, current vacuum assisted biopsy devices are not
capable of being used in conjunction with MRI. This is due to the
fact that many of the components are made of magnetic components
that interfere with the operation of the MRI. It would be desirable
to perform biopsies in conjunction with MRI because it currently is
the only non-invasive visualization modality capable of defining
the margins of the tumor.
[0021] In light of the foregoing disadvantages, a need remains for
a tissue removal device that reliably applies a vacuum without
becoming plugged with blood and bodily fluids. A need also remains
for a tissue removal device that is entirely disposable so that
both exposure to bio-hazard and clean-up time are significantly
minimized, while convenience is maximized. A further need remains
for a tissue removal device that completely severs the maximum
amount of tissue without requiring numerous attempts at cutting the
tissue. A need also remains for a tissue removal device that is MRI
compatible. Finally, a need remains for a biopsy tissue removal
device that is completely automated, therefore making the handheld
biopsy device a more efficient and attractive option.
SUMMARY OF THE INVENTION
[0022] The present invention fulfills the aforementioned needs by
providing a disposable tissue removal device comprising a cutting
element mounted to a handpiece. The cutting element includes an
outer cannula defining a tissue-receiving opening and an inner
cannula concentrically disposed within the outer cannula.
[0023] The outer cannula has a trocar tip at its distal end and a
cutting board snugly disposed within the outer cannula. The inner
cannula defines an inner lumen that extends the length of the inner
cannula, and which provides an avenue for aspiration. The inner
cannula terminates in an inwardly beveled, razor-sharp cutting edge
and is driven by, both a rotary motor, and a reciprocating motor.
As the inner cannula moves past the tissue-receiving opening, the
inwardly beveled edge helps to eliminate the risk of catching the
edge on the tissue-receiving opening. At the end of its stroke, the
inner cannula makes contact with the cutting board to completely
sever the tissue. The cutting board is made of a material that is
mechanically softer than the cutting edge yet hard enough to
withstand the force of the inner cannula.
[0024] An aspiration is applied to the inner lumen through an
aspiration tube. The aspiration tube communicates with a collection
trap that is removably mounted to the handpiece. The aspiration
draws the sample into the tissue-receiving opening and after the
tissue is cut, draws the tissue through the inner cannula to a
collection trap.
[0025] In a specific embodiment, both the rotary motor and the
reciprocating motors are hydraulic motors. Because hydraulic motors
do not require any electrical components, this feature allows all
of the components to be fabricated of MRI compatible materials.
[0026] In another embodiment, the tissue-receiving opening is
formed by opposite longitudinal edges that form a number of teeth.
The teeth face away from the cutting board at the distal end of the
outer cannula. The teeth help prevent the forward motion of the
tissue in the opening as the inner cannula moves forward toward the
cutting board. This feature maximizes the length and overall size
of the core, ultimately resulting in a more efficient lesion
removal.
[0027] In another embodiment, the outer cannula incorporates a
stiffening element opposite the tissue-receiving opening. This
stiffening element aids in maintaining the longitudinal integrity
of the outer cannula as it is advanced through the tissue.
[0028] In addition to the inwardly beveled edge of the inner
cannula, one embodiment incorporates additional features to prevent
the inner cannula from rising up into the tissue-receiving opening.
A bead of stiffening material may be affixed to the inner wall of
the outer cannula, or a dimple may be formed in the inner wall of
the outer cannula. The bead, or dimple urges the inner cannula away
from the tissue-receiving opening and prevents the inner cannula
from catching on the opening.
DESCRIPTION OF THE FIGURES
[0029] FIG. 1 is a top perspective view of a tissue biopsy
apparatus in accordance with one embodiment of the present
invention.
[0030] FIG. 2 is a top elevational view of the tissue biopsy
apparatus shown in FIG. 1.
[0031] FIG. 3A and FIG. 3B are side cross-sectional views of the
tissue biopsy apparatus depicted in FIGS. 1 and 2, with the tissue
cutting inner cannula shown in its retracted and extended
positions.
[0032] FIG. 4 is a perspective view of a cover for the tissue
biopsy apparatus as shown FIG. 1.
[0033] FIG. 5 is an enlarged side cross-sectional view of the
operating end of the tissue biopsy apparatus depicted in FIGS. 1
and 2.
[0034] FIG. 6 is a side partial cross-sectional view of working end
of a tissue biopsy apparatus in accordance with an alternative
embodiment.
[0035] FIG. 7 is an end cross-sectional view of the apparatus
depicted in FIG. 6, taken along line 7-7 as viewed in the direction
of the arrows.
[0036] FIG. 8 is an end cross-sectional view similar to FIG. 7
showing a modified configuration for a stiffening member.
[0037] FIG. 8(a) is an end cross-sectional view similar to FIG. 7
showing a modified configuration for another stiffening member.
[0038] FIG. 9 is an enlarged side cross-sectional view of a fluid
introduction port at the hub connecting the outer cannula to the
handpiece for a tissue biopsy apparatus as depicted in FIG. 1.
[0039] FIG. 10 is a schematic drawing of the hydraulic control
system for the operation of the tissue biopsy apparatus shown in
FIG. 1.
[0040] FIG. 11 is a schematic drawing of a control system for an
electric rotary motor for use with the apparatus of the present
invention.
[0041] FIG. 12 is a top elevational view of a tissue biopsy
apparatus according to a further embodiment of the present
invention.
[0042] FIG. 13 is a side cross-sectional view of the biopsy
apparatus shown in FIG. 12, taken along line 13-13 as viewed in the
direction of the arrows.
[0043] FIG. 14 is a side cross-sectional view of a motor assembly
incorporated into the biopsy apparatus shown in FIG. 12.
[0044] FIG. 15 is an end elevational view from the left end of the
assembly depicted in FIG. 14.
[0045] FIG. 16 is an end elevational view of the right end of the
assembly depicted in FIG. 14.
[0046] FIG. 17 is a top elevational view of a rotary motor assembly
in accordance with one specific embodiment of the invention.
[0047] FIG. 18 is a side elevational view of a cannula hub for
engagement with the assembly depicted in FIG. 14.
[0048] FIG. 19 is a rear elevational view of the cannula hub shown
in FIG. 18.
[0049] FIG. 20 is a side cross-sectional view of the cannula hub
shown in FIG. 18.
[0050] FIG. 21 is a top perspective view of an upper housing
component of the biopsy apparatus depicted in FIG. 12.
[0051] FIG. 22 is an end cross-sectional view of the upper housing
shown in FIG. 21, taken along line 22-22 as viewed in the direction
of the arrows.
[0052] FIG. 23 is a top perspective view of a lower housing for use
with the biopsy apparatus shown in FIG. 12.
[0053] FIG. 24 is a top elevational view of the lower housing shown
in FIG. 23.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0054] For the purposes of promoting an understanding of the
principles of the invention, reference will now be made to the
embodiments illustrated in the drawings and specific language will
be used to describe the same. It will nevertheless be understood
that no limitation of the scope of the invention is thereby
intended. The invention includes any alterations and further
modifications in the illustrated devices and described methods and
further applications of the principles of the invention which would
normally occur to one skilled in the art to which the invention
relates.
[0055] A tissue biopsy apparatus 10 in accordance with one
embodiment of the present invention is shown in FIGS.
[0056] The apparatus 10 includes a cutting element 11 mounted to a
handpiece 12. The cutting element 11 is sized for introduction into
a human body. Most particularly, the present invention concerns an
apparatus for excising breast tissue samples. Thus, the cutting
element 11 and the overall biopsy apparatus 10 are configured for
ease of use in this surgical environment. In the illustrated
embodiment, the biopsy apparatus 10 is configured as a hand-held
device. However, the same inventive principles can be employed in a
tissue biopsy apparatus that is used stereotatically in which the
apparatus is mounted on a support fixture that is used to position
the cutting element 11 relative to the tissue to be sampled.
Nevertheless, for the purposes of understanding the present
invention, the tissue biopsy apparatus will be described as a
hand-held device.
[0057] The cutting element 11 is configured as "tube-within-a-tube"
cutting device. More specifically, the cutting element 11 includes
an outer cannula 15 terminating in a tip 16. Preferably, the tip is
a trocar tip that can be used to penetrate the patient's skin.
Alternatively, the tip 16 can simply operate as a closure for the
open end of the cannula 15. In this instance, a separate introducer
would be required.
[0058] The cutting element 11 further includes an inner cannula 17
that fits concentrically within the outer lumen 27 (FIG. 5) of the
outer cannula 15. In the most preferred embodiment, both a rotary
motor 20 (FIG. 1) and a reciprocating motor 22 drive the inner
cannula 17. Both motors are supported within the handpiece 12.
Again, in accordance with the preferred embodiment the rotary motor
20 and reciprocating motor 22 are configured for simultaneous
operation to translate the inner cannula 17 axially within the
outer cannula 15, while rotating the inner cannula 17 about its
longitudinal axis.
[0059] One specific configuration of the working end of the cutting
element 11 is depicted in FIG. 5. The outer cannula 15 defines a
tissue-receiving opening 25, which communicates with the outer
lumen 27. A pair of opposite longitudinal edges 26 (FIGS. 1 and 2)
define the tissue-receiving opening 25. The outer cannula 15 is
open at its distal end 28 with the trocar tip 16 engaged therein.
Preferably, the trocar tip 16 forms an engagement hub 30 that fits
tightly within the distal end 28 of the outer cannula 15. The hub
30 can be secured by welding, press-fit, adhesive or other means
suitable for a surgical biopsy instrument.
[0060] The working end of the cutting element 11 further includes a
cutting board 31 that is at least snugly disposed within the outer
lumen 27 at the distal end 28 of the outer cannula 15. Most
preferably, the cutting board 31 is in direct contact with the
engagement hub 30 of the trocar tip 16. The cutting board 31 can be
permanently affixed within the outer cannula 15 and/or against the
engagement hub 30 of the trocar tip.
[0061] The inner cannula 17 defines an inner lumen 34 that is
hollow along the entire length of the cannula to provide for
aspiration of the biopsy sample. The inner cannula 17 terminates in
a cutting edge 35. Preferably the cutting edge 35 is formed by an
inwardly beveled surface 36 to provide a razor-sharp edge. The
inwardly beveled surface helps eliminate the risk of catching the
edge 35 on the tissue-receiving opening 25 of the outer cannula. In
addition, the beveled surface 36 helps avoid pinching the biopsy
material between the inner and outer cannulas during a cutting
stroke.
[0062] In a specific embodiment, both the outer cannula 15 and the
inner cannula 17 are formed of a surgical grade metal. Most
preferably, the two cannulae are formed of stainless steel. In the
case of an MRI compatible device, the cannulae can be formed of
Inconel, Titanium or other materials with similar magnetic
characteristics. Likewise, the trocar tip 16 is most preferably
formed of stainless steel honed to a sharp tip. The trocar tip 16
can be suitably bonded to the outer cannula 15, such as by welding
or the use of an appropriate adhesive. In some embodiments, the
inner and outer cannulae can be formed of a non-metallic material
of appropriate strength and stiffness.
[0063] The cutting board 31 is formed of a material that is
configured to reduce the friction between the cutting edge 35 of
the inner cannula 17 and the cutting board 31. The cutting edge 35
necessarily bears against the cutting board 31 when the inner
cannula 17 is at the end of its stroke while severing a tissue
sample. Since the inner cannula is also rotating, the cuffing edge
necessarily bears directly against the cutting board 31,
particularly after the tissue sample has been cleanly severed. In
prior devices, the impact-cutting surface has been formed of the
same material as the cutting element. This leads to significant
wear or erosion of the cutting edge. When numerous cuffing cycles
are to be performed, the constant wear on the cutting edge
eventually renders it incapable of cleanly severing a tissue
sample.
[0064] Thus, the present invention contemplates forming the cutting
board 31 of a material that reduces this frictional wear. In one
embodiment, the cutting board 31 is formed of a material that is
mechanically softer than the material of the cutting edge 35.
However, the cutting board 31 cannot be so soft that the cutting
edge 35 forms a pronounced circular groove in the cutting board,
which significantly reduces the cutting efficiency of the inner
cannula. In a most preferred embodiment of the invention, the
cutting board 31 is formed of a plastic material, such as
polycarbonate, ABS or DELRIN.RTM.
[0065] Returning again to FIGS. 1, 2 and 3A-3B, the rotary motor 20
includes a motor housing 39 that is sized to reciprocate within the
handpiece 12. The housing 39 defines a pilot port 40 that is
connected to the hydraulic control system 150 (see FIG. 10) by
appropriate tubing. The present invention contemplates that the
motor 20 can be a number of hydraulically powered rotating
components. Most preferably, the motor 20 is an air motor driven by
pressured air. Thus, the motor 20 includes a vaned rotor 42 that is
mounted on a hollow tubular axle 43 extending through the motor
housing 39. The axle 43 is supported on bearings 44 at opposite
ends of the housing so that the rotor 42 freely rotates within the
motor housing 39 under pneumatic pressure.
[0066] In the illustrated embodiment, tubular axle 43 is connected
to the proximal end 37 of the inner cannula 17 by way of a coupler
46. The ends of the two tubes are mounted within the coupler 46 and
held in place by corresponding set screws 47. Preferably the
coupler 46 is formed of a plastic material that provides a
generally airtight seal around the joint between the inner cannula
17 and the tubular axle 43. It is important that the coupler 46
provide a solid connection of the inner cannula 17 to the rotating
components of the motor 20 so that the inner cannula 17 does not
experience any torrential slip during the cutting operation.
[0067] Since the inner cannula 17 provides an avenue for aspiration
of the biopsy sample, the invention further contemplates an
aspiration tube 50 that mates with the tubular axle 43. Thus, the
tissue aspiration path from the working end of the cutting element
11 is along the inner lumen 34 of the inner cannula 17, through the
tubular axle 43 of the rotary motor 20, and through the aspiration
tube 50 to a tissue collection location in the form of a collection
trap 55. In order to maintain the vacuum or aspiration pressure
within this aspiration path, the aspiration tube 50 must be fluidly
sealed against the tubular axle 43. Thus, the motor housing 39
defines a mounting hub 51 into which the aspiration tube 50 is
engaged. The position of the aspiration tube 50 is fixed by way of
a set screw 52 passing through the mounting hub 51. In contrast to
the joint between the inner cannula 17 and the tubular axle 43, the
joint between the aspiration tube 50 and the tubular axle 43 allows
relative rotational between the two components. The tubular axle
43, of course, rotates with the rotor 42. However, the aspiration
tube 50 need not rotate for use with the biopsy apparatus of the
present invention. The mounting hub 51 can include an arrangement
of seal rings (not shown) at the joint between the aspiration tube
50 and the tubular axle 43 to further seal the aspiration
system.
[0068] The aspiration tube 50 communicates with a collection trap
55 that is removably mounted to the handpiece 12. The collection
trap 55 includes a pilot port 107 that is connected by appropriate
tubing to the hydraulic control system 150, as described in more
detail herein. For the present purposes, it is understood that a
vacuum or aspiration pressure is drawn through the pilot port 107
and the collection trap 55. This vacuum then draws a tissue sample
excised at the working end of the cutting element 11, all the way
through the inner cannula 17, tubular axle 43 and aspiration tube
50 until it is deposited within the trap. Details of the collection
trap 55 will be discussed herein.
[0069] As explained above, the present invention contemplates an
inner cannula 17 that performs its cutting operation by both rotary
and reciprocating motion. Thus, the handpiece 12 supports a
reciprocating motor 22. In one aspect of the invention, both motors
20 and 22 are hydraulically powered, most preferably pneumatically.
This feature allows the motors to be formed of plastic, since no
electrical components are required. In fact, with the exception of
the outer cannula 15, trocar tip 16 and inner cannula 17, every
component of the biopsy apparatus 10 in accordance with the present
invention can be formed of a non-metallic material, most preferably
a medical grade plastic. Thus, the biopsy apparatus 10 is eminently
compatible with surgical imaging systems that may be used during
the biopsy procedure. The compatibility of the apparatus 10 with
Magnetic Resonance Imaging (MRI) is important because MRI is
currently the only non-invasive visualization modality capable of
defining the margins of the tumor. In addition, since the biopsy
apparatus is formed of a relatively inexpensive plastic (as opposed
to a more expensive metal), the entire apparatus can be disposable.
Moreover, the elimination of substantially all metal components
reduces the overall weight of the handpiece 12, making it very
easily manipulated by the surgeon.
[0070] Referring most specifically to FIGS. 3A and 3B, the
reciprocating motor 22 includes a pneumatic cylinder 60. The
cylinder 60 includes a pilot port 61 that connects the cylinder to
the hydraulic control system 150 through appropriate tubing. The
motor 22 includes a piston 63 that reciprocates within the cylinder
60 in response to hydraulic fluid pressure provided at the pilot
port 61. The piston 63 includes a central bore 64 for mounting the
piston 63 to the aspiration tube 50. In one embodiment, the
aspiration tube 50 is press-fit within the bore 64. The engagement
between the aspiration tube 50 and the piston 63 can be enhanced by
use of a set screw (not shown) or an adhesive or epoxy. At any
rate, it is essential that the aspiration tube 50 and piston 63
move together, since the motor 22 must eventually drive the inner
cannula 17 axially within the outer cannula.
[0071] It should be understood that in addition to powering the
inner cannula, the piston 63 also reciprocates the rotary motor 20,
which is essentially mounted to the reciprocating aspiration
conduit. This movement is depicted by comparing the position of the
rotary motor 20 between FIG. 3A and FIG. 3B. More specifically, the
motor 20 as well as the aspiration conduit, including the inner
cannula 17, moves within the handpiece 12. Preferably, the
handpiece housing 70 is provided with openings 73 (FIG. 3B) at its
opposite ends for slidably supporting the aspiration tube 50 and
inner cannula 17. Since the distal housing 70 is preferably formed
of a plastic material, no thrust bearings or rotary bearings are
necessary to accommodate low friction axial movement of the cannula
through the housing openings 73.
[0072] The biopsy apparatus 10 includes a handpiece 12 that carries
all of the operating components and supports the outer and inner
cannulas. The handpiece 12 includes a distal housing 70 within
which is disposed the rotary motor 20. The distal end 71 of the
housing 70 is configured into a fitting 72. This fitting 72 engages
a mating flange 77 on an outer cannula hub 75. The hub 75 supports
the outer cannula 15 within an engagement bore 76 (see FIG.
3B).
[0073] In accordance with one aspect of the present invention, the
engagement between the outer cannula hub 75 and the distal end 71
of the housing 70 need not be airtight. In other words, the mating
components of the fitting between the two parts need not be capable
of generating a fluid-tight seal. In accordance with one embodiment
of the invention, the engagement between the hub 75 and the housing
70 for supporting the outer cannula 15 provides a leak path through
the outer lumen 27 to the atmosphere. In the use of the tissue
biopsy apparatus 10, providing aspiration through the inner lumen
34 of the inner cutting cannula 17 will draw tissue through the
inner lumen. As the tissue advances farther along the lumen, in
some instances a vacuum can be created behind the advancing tissue.
At some point in these instances, the tissue will stop advancing
along the length of the inner lumen because the vacuum behind the
tissue sample equals the vacuum in front of the tissue sample that
is attempting to draw the sample to the collection trap 55. Thus,
the leak path through the outer lumen 27 allows atmospheric air to
fall in behind the tissue sample when the inner cutter is retracted
from the cutting board. The atmospheric air helps to relieve the
vacuum behind the advancing tissue and aids in drawing the tissue
down the length of the aspiration channel to the collection trap
55. However, in some applications, particularly where smaller
"bites" of the target tissue are taken, the atmospheric air leak
path is not essential.
[0074] Preferably the fitting 72 and the mating flange 77 can be
engaged by simple twisting motion, most preferably via Luer-type
fittings. In use, the cannula hub 75 is mounted on the handpiece
12, thereby supporting the outer cannula 15. The handpiece can then
be used to project the outer cannula into the body adjacent the
sample site. In certain uses of the biopsy apparatus 10, it is
desirable to remove the handpiece 12 from the cannula hub 75
leaving the outer cannula 15 within the patient. For example, the
outer cannula 15 can be used to introduce an anesthetic. In other
applications, once the target tissue has been completely excised,
the outer cannula can be used to guide a radio-opaque marker to
mark the location the removed material.
[0075] Returning again to the description of the housing 70, the
housing defines an inner cavity 79 that is open through an access
opening 81. The access opening 81 is preferably provided to
facilitate assembly of the tissue biopsy apparatus 10. The distal
end 71 of the housing 70 can be provided with a pair of distal
braces 80 that add stiffness to the distal end 71 while the
apparatus is in use. The braces 80 allow the distal housing 70 to
be formed as a thin-walled plastic housing. Similar braces can be
provided at the opposite end of the distal housing as necessary to
add stiffness to the housing.
[0076] The distal housing is configured to support the
reciprocating motor 22 and in particular the cylinder 60. Thus, in
one embodiment of the invention, the proximal end 83 of the distal
housing 70 defines a pressure fitting 84. It is understood that
this pressure fitting 84 provides a tight leak-proof engagement
between the distal end 88 of the cylinder 60 and the proximal end
83 of the housing. In one specific embodiment, the pressure fitting
84 forms a spring cavity 85 within which a portion of the return
spring 66 rests. In addition, in a specific embodiment, the
pressure fitting 84 defines distal piston stop 86. The piston 63
contacts these stops at the end of its stroke. The location of the
piston stop 86 is calibrated to allow the cutting edge 35 to
contact the cutting board 31 at the working end of the cutting
element 11 to allow the cutting edge to cleanly sever the biopsy
tissue.
[0077] In the illustrated embodiment, the cylinder 60 is initially
provided in the form of an open-ended cup. The open end,
corresponding to distal end 88, fastens to the pressure fitting 84.
In specific embodiments, the pressure fitting can include a
threaded engagement, a press-fit or an adhesive arrangement.
[0078] The cylinder cup thus includes a closed proximal end 89.
This proximal end defines the pilot port 61, as well as a central
opening 62 (FIG. 3B) through which the aspiration tube 50 extends.
Preferably, the proximal end 89 of the cylinder 60 is configured to
provide a substantially airtight seal against the aspiration tube
50 even as it reciprocates within the cylinder due to movement of
the piston 63. The proximal end 89 of the cylinder 60 defines a
proximal piston stop 90, which can either be adjacent the outer
cylinder walls or at the center portion of the proximal end. This
proximal piston stop 90 limits the reverse travel of the piston 63
under action of the return spring 66 when pressure within the
cylinder has been reduced.
[0079] In a further aspect of the invention, the collection trap 55
is mounted to the handpiece 12 by way of a support housing 93. It
should be understood that in certain embodiments, the handpiece 12
can be limited to the previously described components. In this
instance, the collection trap 55 can be situated separate and apart
from the handpiece, preferably close to the source of vacuum or
aspiration pressure. In this case, the proximal end of the
aspiration tube 50 would be connected to the collection trap by a
length of tubing. In the absence of the collection trap 55, the
aspiration tube 50 would reciprocate away from and toward the
proximal end of the cylinder 60, so that it is preferable that the
handpiece includes a cover configured to conceal the reciprocating
end of the aspiration tube.
[0080] However, in accordance with the most preferred embodiment,
the collection trap 55 is removably mounted to the handpiece 12. A
pair of longitudinally extending arms 94, that define an access
opening 95 therebetween, forms the support housing 93. The support
housing 93 includes a distal end fitting 96 that engages the
proximal end 89 of cylinder 60. A variety of engagements are
contemplated, preferably in which the connection between the two
components is generally airtight. The proximal end 97 of the
support housing 93 forms a cylindrical mounting hub 98. As best
shown in FIG. 1, the mounting hub 98 surrounds a proximal end of
the collection trap 55. The hub forms a bayonet-type mounting
groove 99 that receives pins 103 attached to the housing 102 of the
trap 55. A pair of diametrically opposite wings 104 can be provided
on the housing 102 to facilitate the twisting motion needed to
engage the bayonet mount between the collection trap 55 and the
support housing 93. While the preferred embodiment contemplates a
bayonet mount, other arrangements for removably connecting the
collection trap 55 to the support housing 93 are contemplated. To
be consistent with one of the features of the invention, it is
preferable that this engagement mechanism be capable of being
formed in plastic.
[0081] In order to accommodate the reciprocating aspiration tube,
the support housing 93 is provided with an aspiration passageway
100 that spans between the proximal and distal ends of the housing.
Since the aspiration tube 50 reciprocates, it preferably does not
extend into the collection trap 55. As excised tissue is drawn into
the trap 55, a reciprocating aspiration tube 50 can contact the
biopsy material retained within the trap. This movement of the tube
can force tissue into the end of the tube, clogging the tube.
Moreover, the reciprocation of the aspiration tube can compress
tissue into the end of the trap, thereby halting the aspiration
function.
[0082] The collection trap 55 includes a housing 102, as previously
explained. The housing forms a pilot port 107, which is connectable
to a vacuum generator. Preferably in accordance with the present
invention, appropriate tubing to the hydraulic control system 150
connects the pilot port 107. The trap 55 includes a filter element
110 mounted within the trap. In the preferred embodiment, the
filter element is a mesh filter than allows ready passage of air,
blood and other fluids, while retaining excised biopsy tissue
samples, and even morcellized tissue. In addition, the filter
element 110 is preferably constructed so that vacuum or aspiration
pressure can be drawn not only at the bottom end of the filter
element, but also circumferentially around at least a proximal
portion of the element 110. In this way, even as material is drawn
toward the proximal end of the filter, a vacuum can still be drawn
through other portions of the filter, thereby maintaining the
aspiration circuit.
[0083] The handpiece 12 can include individual covers for closing
the access opening 81 in the distal housing 70 and the access
openings 95 in the support housing 93. Those covers can support
tubing for engagement with the pilot ports 40 and 61. Alternatively
and most preferably, a single cover 13 as depicted in FIG. 4, is
provided for completely enclosing the entire handpiece. The distal
end 71 of the housing 70 can define a number of engagement notches
115 equally spaced around the perimeter of the distal end. The
handpiece cover 13 can then include a like number of equally
distributed tangs 117 projecting inwardly from the inner surface
from the 118. These tangs are adapted to snap into the engagement
notches 115 to hold the cover 113 in position over the handpiece
12. The cover can be attached by sliding axially over the handpiece
12. The cover 13 can include fittings for fluid engagement with the
two pilot ports 40 and 61. Alternatively, the cover can be formed
with openings for insertion of engagement tubing to mate with the
respective pilot ports to provide hydraulic fluid to the rotary
motor 20 and the reciprocating motor 22. In a specific embodiment,
the cover 13 extends from the distal end 71 of the distal housing
70 to the proximal end 97 of the support housing 93. The cover can
thus terminate short of the bayonet mounting feature between the
support housing and the collection trap 55. Although not shown in
the figures, the proximal end 97 of the support housing 93 can be
configured to include a similar array of engagement notches with a
corresponding array of mating tangs formed at the proximal end of
the cover 13.
[0084] It can be appreciated from the foregoing discussion that the
biopsy apparatus 10 of the present invention provides a complete
"closed" tissue excision and recovery system. In other words,
unlike prior biopsy devices, the apparatus 10 is fluid tight so
that no bodily fluids can escape. Biopsy procedures with many prior
devices involves significant blood splatter due to the nature in
which the tissue samples are extracted and recovered. With the
present invention, the biopsy apparatus 10 provides a closed path
from the tissue receiving opening 25 to the collection trap 55,
while still maintaining the highly efficient reciprocating and
rotating cutting operation.
[0085] Referring now to FIGS. 6-8, alternative embodiments of the
outer cannula are depicted. As shown in FIG. 6 an outer cannula 125
includes a tissue-receiving opening 126. The opening is formed by
opposite longitudinal edges 127. In one specific embodiment, a
number of teeth 129 are formed at each longitudinal edge 127. As
depicted in the figure, the teeth are proximally facing--i.e., away
from the cutting board 31 (not shown) at the distal end of the
outer cannula. With this orientation, the teeth 129 help prevent
forward motion of tissue drawn into the opening 126 as the inner
cannula 17 moves forward toward the cutting board. In prior
devices, as the reciprocating cutting element advances through the
outer cannula, the cutting edge not only starts to sever the
tissue, it also pushes tissue in front of the inner cannula. Thus,
with these prior devices, the ultimate length of the biopsy sample
retrieved with the cut is smaller than the amount of tissue drawn
into the tissue-receiving opening of the outer cannula. With the
teeth 129 of the outer cannula 125 of this embodiment of the
invention, the tissue sample removed through the inner cannula 17
is substantially the same length as the tissue-receiving opening
126. As the inner cannula 17 advances into the tissue, each of the
teeth 129 tends to hold the tissue in place as the cutting edge 35
severs the tissue adjacent the outer cannula wall. With this
feature, each "bite" is substantially as large as possible so that
a large tissue mass can be removed with much fewer "bites" and in a
shorter period of time. In addition to supporting the subject
tissue as the inner cannula advances, the teeth can also cut into
the tissue to prevent it from retracting out of the opening as the
inner cuffing cannula 17 advances.
[0086] The outer cannula 125 depicted in FIG. 6 can also
incorporate a stiffening element 131 opposite the tissue-receiving
opening 126. The stiffening element 131 adds bending stiffness to
the outer cannula 125 at the distal end in order to maintain the
longitudinal integrity of the outer cannula 125 as it is advanced
into a tissue mass. In some prior devices that lack such a
stiffening element, the working end of the cutting device is
compromised as it bends slightly upward or downward as the outer
cannula passes into the body. This bending can either close or
expand the tissue-receiving opening, which leads to difficulties in
excising and retrieving a tissue sample. The cutting mechanism of
the present invention relies upon full, flush contact between the
cutting edge of the inner cannula 17 and the cutting board 31. If
the end of the outer cannula 125 is slightly askew, this contact
cannot be maintained, resulting in an incomplete slice of the
tissue sample.
[0087] As depicted in the cross-sectional view of the FIG. 7, the
stiffening element 131 in one embodiment is a crimp extending
longitudinally in the outer wall of the cannula substantially
coincident with the tissue-receiving opening 126. The outer cannula
125' depicted in FIG. 8 shows two additional versions of a
stiffening element. In both cases, a bead of stiffening material is
affixed to the outer cannula. Thus in one specific embodiment, a
bead 131' is adhered to the inner wall of the outer cannula. In a
second specific embodiment, a bead 131" is affixed to the outside
of the outer cannula. In either case, the beads can be formed of a
like material with the outer cannula, and in both cases, the beads
provide the requisite additional bending stiffness. Another version
of a stiffening element is shown if FIG. 8(a). In this case, a
layer 131'" of additional stainless steel is bonded to the outer
wall of the outer cannula 125".
[0088] Returning to FIG. 6, a further feature that can be
integrated into the outer cannula 125 is the dimple 135. One
problem frequently experienced by tube-within-a-tube cutters is
that the inner reciprocating cutter blade contacts or catches on
the outer cannula at the distal edge of the tissue-receiving
opening. With the present invention, the dimple 135 urges the inner
cannula 17 away from the tissue-receiving opening 126. In this way,
the dimple prevents the cutting edge of the inner cannula 17 from
catching on the outer cannula as it traverses the tissue-receiving
opening. In the illustrated embodiment of FIG. 6, the dimple 135 is
in the form of a slight crimp in the outer cannula 125.
Alternatively, as with the different embodiments of the stiffening
element, the dimple 135 can be formed by a protrusion affixed or
adhered to the inner surface of the outer cannula. Preferably, the
dimple 135 is situated immediately proximal to the tissue-receiving
opening to help maintain the distance between the cutting edge and
the tissue-receiving opening.
[0089] As previously described, the outer cannula 15 is supported
by a hub 75 mounted to the distal end of the handpiece. In an
alternative embodiment depicted in FIG. 9, the outer cannula hub
140 provides a mean for introducing fluids into the outer lumen 27
of the outer cannula. Thus, the hub 140 includes an engagement bore
141 within which the outer cannula 15 is engaged. The hub also
defines a flange 142 configured for mating with the fitting 72 at
the distal end 71 of the housing 70. Thus, the outer cannula hub
140 is similar to the hub 75 described above. With this embodiment,
however, an irrigation fitting 145 is provided. The fitting defines
an irrigation lumen 146 that communicates with the engagement bore
141.
[0090] Ultimately, this irrigation lumen is in fluid communication
with the outer lumen 27 of the outer cannula 15. The irrigation
fitting 145 can be configured for engagement with a fluid-providing
device, such as a syringe. The hub 140 thus provides a mechanism
for introducing specific fluids to the biopsy site. In certain
procedures, it may be necessary to introduce additional anesthetic
to the sampling site, which can be readily accommodated by the
irrigation fitting 145.
[0091] As discussed above, the preferred embodiment of the tissue
biopsy apparatus 10 according to the present invention relies upon
hydraulics or pneumatics for the cutting action. Specifically, the
apparatus includes a hydraulic rotary motor 20 and a hydraulic
reciprocating motor 22. While the apparatus 10 can be adapted for
taking a single biopsy slice, the preferred use is to completely
remove a tissue mass through successive cutting slices. In one
typical procedure, the cutting element 11 is positioned directly
beneath a tissue mass, while an imaging device is disposed above
the mass. The imaging device, such as an ultra-sound imager,
provides a real-time view of the tissue mass as the tissue biopsy
apparatus 10 operates to successively remove slices of the mass.
Tissue is continuously being drawn into the cutting element 11 by
the aspiration pressure or vacuum drawn through the inner cannula
17. Successive reciprocation of the inner cannula 17 removes large
slices of the mass until it is completely eliminated.
[0092] In order to achieve this continuous cutting feature, the
present invention contemplates a hydraulic control system 150, as
illustrated in the diagram of FIG. 10. Preferably the bulk of the
control system is housed within a central console. The console is
connected to a pressurized fluid source 152. Preferably the fluid
source provides a regulated supply of filtered air to the control
system 150.
[0093] As depicted in this diagram of FIG. 10, pressurized fluid
from the source as provided at the several locations 152 throughout
the control system. More specifically, pressurized fluid is
provided to five valves that form the basis of the control
system.
[0094] At the left center of the diagram of FIG. 10, pressurized
fluid 152 passes through a pressure regulator 154 and gauge 155.
The gauge 155 is preferably mounted on the console for viewing by
the surgeon or medical technician. The pressure regulator 154 is
manually adjustable to control the pressurized fluid provided from
the source 152 to the two-position hydraulic valve 158. The valve
158 can be shifted between a flow path 158a and a flow path 158b. A
return spring 159 biases the hydraulic valve to its normal position
158a.
[0095] In the normally biased position of flow path 158a, the valve
158 connects cylinder pressure line 161 to the fluid source 152.
This pressure line 161 passes through an adjustable flow control
valve 162 that can be used to adjust the fluid flow rate through
the pressure line 161. Like the pressure gauge 155 and pressure
regulator 154, the adjustable flow control valve 162 can be mounted
on a console for manipulation during the surgical procedure.
[0096] The pressure line 161 is connected to the pilot port 61 of
the reciprocating motor 22. Thus, in the normal or initial position
of the hydraulic control system 150, fluid pressure is provided to
the cylinder 60 to drive the piston 63 against the biasing force of
the return spring 66. More specifically with reference to FIG. 3B,
the initial position of the hydraulic valve 158 is such that the
reciprocating motor and inner cannula are driven toward the distal
end of the cutting element. In this configuration, the inner
cannula 17 covers the tissue-receiving opening 25 of the outer
cannula 15. With the inner cannula so positioned, the outer cannula
can be introduced into the patient without risk of tissue filling
the tissue-receiving opening 25 prematurely.
[0097] Pressurized fluid along cylinder pressure 161 is also fed to
a pressure switch 165. The pressure switch has two positions
providing flow paths 165a and 165b. In addition, an adjustable
return spring 166 biases this switch to its normal position at
which fluid from the pressure source 152 terminates within the
valve. However, when pressurized fluid is provided through cylinder
pressure line 161, the pressure switch 165 moves to its flow path
165b in which the fluid source 152 is hydraulically connected to
the pressure input line 168. This pressure input line 168 feeds an
oscillating hydraulic valve 170. It is this valve that principally
operates to oscillate the reciprocating motor 22 by alternately
pressurizing and releasing the two-position hydraulic valve 158.
The pressure switch 165 is calibrated to sense an increase in
pressure within the cylinder pressure line 161 or in the
reciprocating motor cylinder 60 that occurs when the piston 66 has
reached the end of its stroke. More specifically, the piston
reaches the end of its stroke when the inner cannula 17 contacts
the cutting board 31. At this point, the hydraulic pressure behind
the piston increases, which increase is sensed by the pressure
valve 165 to stroke the valve to the flow path 165b.
[0098] The oscillating hydraulic valve 170 has two positions
providing flow paths 170a and 170b. In position 170a, input line
179 is fed to oscillating pressure output line 172. With flow path
170b, the input line 179 is fed to a blocked line 171. Thus, with
fluid pressure provided from pressure switch 165 (through flow path
165b), the oscillating valve 170 opens flow path 170a which
completes a fluid circuit along output line 172 to the input of the
hydraulic valve 158.
[0099] Fluid pressure to output line 172 occurs only when there is
fluid pressure within input line 179. This input line is fed by
valve 176, which is operated by foot pedal 175. The valve 176 is
biased by a return spring 177 to the initial position of flow path
176a. However, when the foot pedal 175 is depressed, the valve 176
is moved against the force of the spring to flow path 176b. In this
position, pressurized fluid from the source 152 is connected to the
foot pedal input line 179. When the oscillating hydraulic valve 170
is in its initial position flow path 170a, pressurized fluid then
flows through input line 179 to output line 172 and ultimately to
the hydraulic valve 158.
[0100] The fluid pressure in the output line 172 shifts the valve
158 to the flow path 158b. In this position, the fluid pressure
behind the piston 63 is relieved so that the return spring 66
forces the piston toward the proximal end. More specifically, the
return spring retracts the inner cannula 17 from the tissue cutting
opening 25. The relief of the fluid pressure in line 161 also
causes the pressure switch 165 to return to its initial neutral
position of flow path 165a, due to the action of the return spring
166. In turn, with the flow path 165a, the pressure input line 168
is no longer connected to the fluid source 152, so no pressurized
fluid is provided to the oscillating hydraulic valve 170. Since
this valve is not spring biased to any particular state, its
position does not necessarily change, except under conditions
described herein.
[0101] Returning to the foot pedal 175 and valve 176, once the foot
pedal is released, the biasing spring 177 forces the valve 176 from
its flow path 176b to its normal initial flow path 176a. In this
position the foot pedal input line 179 is no longer connected to
the fluid source 152. When the oscillating valve 170 is at flow
path 170a, the fluid pressure through output line 172 is
eliminated. In response to this reduction in fluid pressure,
hydraulic valve 158 is shifted to its original flow path 158a by
operation of the return spring 159. In this position, the cylinder
pressure line 161 is again connected to the fluid source 152, which
causes the reciprocating motor 22 to extend the inner cannula 17 to
its position blocking the tissue-receiving opening 25. Thus, in
accordance with the present invention, the hydraulic control system
150 starts and finishes the tissue biopsy apparatus 10 with the
tissue-receiving opening closed. It is important to have the
opening closed once the procedure is complete so that no additional
tissue may be trapped or pinched within the cutting element 11 as
the apparatus is removed from the patient.
[0102] Thus far the portion of the hydraulic control system 150
that controls the operation of the reciprocating motor 22 has been
described. The system 150 also controls the operation of the rotary
motor 20. Again, in the most preferred embodiment, the motor 20 is
an air motor. This air motor is controlled by another hydraulic
valve 182. As shown in FIG. 10, the initial position of the valve
provides a flow path 182a in which the fluid source 152 is
connected to blocked line 183. However, when the hydraulic valve
182 is pressurized, it moves to flow path 182b in which the fluid
source 152 is connected to the pilot port 140 of the air motor. In
this position, pressurized fluid continuously drives the air motor
20, thereby rotating the inner cannula 17. It can be noted
parenthetically that a muffler M can be provided on the air motor
to reduce noise.
[0103] The rotary motor hydraulic valve 182 is controlled by fluid
pressure on pressure activation line 180. This activation line 180
branches from the foot pedal input line 179 and is connected to the
foot pedal switch 176. When the foot pedal 175 is depressed, the
switch moves to its flow path 176b. In this position the pressure
activation line 180 is connected to the fluid source 152 so fluid
pressure is provided directly to the rotary motor hydraulic valve
182. As with the other hydraulic valves, the valve 182 includes a
biasing spring 184 that must be overcome by the fluid pressure at
the input to the valve.
[0104] It should be understood that since the fluid control for the
rotary motor 20 is not fed through the oscillating hydraulic valve
170, the motor operates continuously as long as the foot pedal 175
is depressed. In addition, it should also be apparent that the
speed of the rotary motor 20 is not adjustable in the illustrated
embodiment. Since the motor 20 is connected directly to the fluid
source 152, which is preferably regulated at a fixed pressure, the
air motor actually operates at one speed. On the other hand, as
discussed above, the reciprocating motor 22 is supplied through a
pressure regulator 154 and a flow control valve 162. Thus, the
speed of reciprocation of the cutting blade 35 is subject to
control by the surgeon or medical technician. The reciprocation of
the cutting element 11 can be a function of the tissue being
sampled, the size of the tissue biopsy sample to be taken, and
other factors specific to the particular patient. These same
factors generally do not affect the slicing characteristic of the
cutting edge 35 achieved by rotating the inner cannula.
[0105] The hydraulic control system 150 also regulates the
aspiration pressure or vacuum applied through the aspiration
conduit, which includes the inner cannula 17. In the illustrated
embodiment, the pressure activation line 180 branches to feed an
aspiration valve 185. The valve is movable from its initial flow
path 185a to a second flow path 185b. In the initial flow path, the
fluid source 152 is connected to a blocked line 186. However, when
fluid pressure is applied on line 180, the valve 185 shifts against
the biasing spring 187 to the flow path 185b. In this path, the
venturi element 190 is connected to the fluid source. This venturi
element thus generates a vacuum in a vacuum control line 193 and in
aspiration line 191. Again, as with the air motor, the venturi
element 190 can include a muffler M to reduce noise within the
handpiece.
[0106] As long as the foot pedal 175 is depressed and the valve 176
is in its flow path 176b, fluid pressure is continuously applied to
the aspiration hydraulic valve 195 and the venturi element 190
generates a continuous vacuum or negative aspiration pressure. As
with the operation of the rotary motor, this vacuum is not
regulated in the most preferred embodiment. However, the vacuum
pressure can be calibrated by a selection of an appropriate venturi
component 190.
[0107] When the venturi component 190 is operating, the vacuum
drawn on control line 193 operates on vacuum switch 194. A variable
biasing spring 195 initially maintains the vacuum switch 194 at its
flow path 194a. In this flow path, the vacuum input line 196 is not
connected to any other line. However, at a predetermined vacuum in
control line 193, the valve moves to flow path 194b. In this
position, the vacuum input line 196 is connected to pressure line
192. In the preferred embodiment, the vacuum switch 194 operates in
the form of a "go-nogo" switch--in other words, when the aspiration
vacuum reaches a predetermined operating threshold, the vacuum
switch is activated. When the vacuum switch 184 is initially
activated, it remains activated as long as the foot pedal is
depressed. Thus vacuum input line 196 is continuously connected to
pressure line 192 as long as the foot pedal 175 is depressed.
[0108] Looking back to the hydraulic valve 158, the fluid pressure
in line 192, and ultimately in vacuum input line 196, is determined
by the state of valve 158. When the valve 158 is in its flow path
158a in which regulated fluid pressure is provided to the
reciprocating motor 22, the pressure line 192 is dead. However,
when the valve 158 moves to flow path 158b, pressure line 192 is
connected to the regulated fluid source. Pressurized fluid then
flows from pressure line 192, through vacuum switch flow path 194b,
through vacuum input line 196 to the left side of oscillating valve
170, causing the valve to stroke to flow path 170b. When the
oscillating valve 170 is in this flow path, output line 172 is
dead, which allows valve 158 to move to its flow path 158a under
the effect of the return spring 159. In this state, valve 158
allows pressurized fluid to again flow to the reciprocating motor
22 causing it to move through the next cutting stroke.
[0109] Thus, when both the valve 158 and the vacuum switch 194 are
moved to their alternate states, pressurized fluid passes from line
192, through vacuum input line 196, and through an adjustable flow
control valve 197 to a second input for the oscillating hydraulic
valve 170. Pressure on the vacuum input line 196 shifts the
oscillating valve 170 to its second position for flow path 170b. In
this position, pressurized fluid passing through the foot pedal
valve 176 terminates within valve 170. As a consequence, the
pressure in output line 172 drops which allows the hydraulic valve
158 shift back to its original position 158a under operation of the
return spring 159. In this position, fluid pressure is again
supplied to the reciprocating motor 22 to cause the piston 66 to
move through its cutting stroke.
[0110] It should be appreciated that the oscillating valve 170 is
influenced by fluid pressure on lines 168 and 196, and that these
lines will not be fully pressurized at the same time. When the
system is initially energized, pressure from source 152 is
automatically supplied to reciprocating motor 22 and pressure valve
165, causing the valve to move to flow path 165b. In this state,
line 168 is pressurized which shifts oscillating valve 170 to the
left to state 170a. The oscillating valve will remain in that state
until line 196 is pressurized, regardless of the position of
pressure switch 165. It can also be appreciated that in the
preferred embodiment, the fluid pressure on line 196 does not
increase to operating levels until the foot pedal 175 has been
depressed and the aspiration circuit has reached its operating
vacuum.
[0111] In an alternative embodiment, the vacuum switch 194 can be
calibrated to sense fine changes in vacuum. In this alternative
embodiment, the completion of this return stroke can be determined
by the state of the vacuum switch 194. The vacuum switch 194 can
operate as an indicator that a tissue sample has been drawn
completely through the aspiration conduit into the collection trap
55. More specifically, when the vacuum sensed by vacuum switch 194
has one value when the inner cannula is open to atmospheric
pressure. This vacuum pressure changes when a tissue sample is
drawn into the inner cannula 17. The vacuum pressure changes again
when the tissue is dislodged so that the inner cannula is again
open to atmospheric pressure. At this point, the inner cannula 17
is clear and free to resume a cutting stroke to excise another
tissue sample. Thus, the vacuum switch 194 can stroke to its flow
path 194b to provide fluid pressure to the left side of the
oscillating valve 170, causing the valve to stroke to flow path
170b.
[0112] It can be appreciated from this detail explanation that the
hydraulic control system 150 provides a complete system for
continuously reciprocating the axial motor 22. In addition, the
system provides constant continuous pressure to both the rotary
motor 20 and the aspiration line 191, so long as the foot pedal 175
is depressed. Once the foot pedal is released, fluid pressure in
activation line 180 drops which causes the air motor control valve
182 and the aspiration control valve 185 to shift to their original
or normal positions in which fluid pressure is terminated to those
respective components. However, in the preferred embodiment,
pressure is maintained to the reciprocating motor 22 because the
motor is fed through valve 158, which is connected directly to the
fluid source 152.
[0113] The hydraulic control system 150 in the illustrated
embodiment incorporates five controllable elements. First, the
fluid pressure provided to activate the reciprocating motor 22 is
controlled through the regulator 154. In addition, the fluid flow
rate to the piston 66 is controlled via the adjustable control
valve 162. The pressure at which the pressure switch 165 is
activated is determined by an adjustable return spring 166.
Likewise, the aspiration pressure vacuum at which the vacuum switch
194 is activated is controlled by an adjustable return spring 195.
Finally the adjustable flow control valve 197 controls the fluid
flow from the vacuum switch 194 to the oscillating hydraulic valve
170. Each of these adjustable elements controls the rate and
duration of oscillation of the reciprocating motor 22.
[0114] In the preferred embodiment, the pressure switch 165
essentially operates as an "end of stroke" indicators. In other
words, when the inner cannula 17 reaches the end of its forward or
cutting stroke, it contacts the cutting board 31. When it contacts
the cutting board, the pressure in the cylinder pressure line 161
changes dramatically. It is this change that causes the pressure
switch 165 to change states. This state change causes the
oscillating valve 170 to shift valve 158 to terminate fluid
pressure to the motor 22, causing it to stop its cutting stroke and
commence its return stroke.
[0115] During this return stroke, the excised tissue sample is
gradually drawn along the aspiration conduit. Also during the
return stroke, fluid pressure bleeds from pressure line 161 and
pressure switch 165 and ultimately from line 168 feeding
oscillating valve 170. When this valve strokes, fluid pressure
bleeds from valve 158 allowing the valve to return to state 158a to
pressurize the motor 22 for a new cutting stroke. The operation of
each of these hydraulic valves introduces an inherent time delay so
that by the time the pressure to the reciprocating motor 22 has
been restored the aspiration vacuum has pulled the tissue sample
through the entire aspiration conduit and into the collection trap
55.
[0116] The use of a hydraulically controlled inner cutting cannula
provides significant advantages over prior tissue cutting devices.
The use of hydraulics allows most of the operating components to be
formed of inexpensive and light-weight non-metallic materials, such
as medical-grade plastics. The hydraulic system of the present
invention eliminates the need for electrical components, which
means that electrical insulation is unnecessary to protect the
patient.
[0117] Perhaps most significantly, the hydraulically controlled
reciprocation of the inner cutting cannula provides a cleaner and
better-controlled cut of biopsy tissue. Since the reciprocating
motor 22 is fed from a substantially constant source of pressurized
fluid, the pressure behind the motor piston 63 remains
substantially constant throughout the cutting stroke. This
substantially constant pressure allows the inner cutting cannula to
advance through the biopsy tissue at a rate determined by the
tissue itself.
[0118] In other words, when the cutting edge 35 encounters harder
tissue during a cutting stroke, the rate of advancement of the
motor piston 63 and therefor the inner cannula 17 decreases
proportionately. This feature allows the cutting edge to slice
cleanly through the tissue without the risk of simply pushing the
tissue. The rotation of the cutting edge can facilitate this
slicing action. When the inner cannula encounters less dense
tissue, the constant pressure behind the piston 63 allows the
cutting edge to advance more quickly through the tissue.
[0119] In alternative embodiment, the rotary motor 20 can consist
of an electric motor, rather than a pneumatic motor. As depicted in
FIG. 11, the pressure activation line 180 can be fed to an on-off
pressure switch 198 that is governed by an adjustable bias spring
199. When the activation line 180 is pressurized the switch 198
establishes a connection between an electric reciprocating motor 20
and a battery pack 200. Preferably, the battery pack 200 is mounted
within the handpiece 12, but can instead be wired to an external
battery contained within the console.
[0120] In the preferred embodiment, the tissue biopsy apparatus 10
depicted in FIG. 1 has an overall length of under sixteen inches
(16") and an outer diameter less than one and one quarter inches
(1.25"). The outer cannula and therefore the cutting element 11
have a length measured from the handpiece 12 of approximately five
inches (5"). The outer cannula preferably has a nominal outer
diameter of 0.148" and a nominal inner diameter of 0.136". The
inner cannula most preferably has a nominal outer diameter of
0.126" so that it can reciprocate freely within the outer cannula
without catching on the tissue cutting opening. The inner cannula
has a nominal wall thickness of 0.010", which yields a nominal
inner lumen diameter of about 0.106."
[0121] The length of the tissue-receiving opening determines the
length of biopsy sample extracted per each oscillation of the
reciprocating motor 22. In one specific embodiment, the opening has
a length of about 0.7", which means that a 0.7" long tissue sample
can be extracted with each cutting cycle. In order to accommodate a
large number of these biopsy tissue slugs, the collection trap can
have a length of about 2.5" and a diameter of about 0.05". Of
course, the interior volume of the collection trap can vary
depending upon the size of each biopsy slug and the amount of
material to be collected. In a specific embodiment, the filter
disposed within the collection trap 55 manufactured by Performance
Systematix, Inc. of Callondoni, Mich.
[0122] In accordance with a specific embodiment, the cutting stroke
for the inner cannula is about 0.905". The return spring 66 within
the reciprocating motor 22 is preferably a conical spring to reduce
the compressed height of the spring, thereby allow a reduction in
the overall length of the hydraulic cylinder 60. In addition, the
return spring 66 can be calibrated so that the return stroke occurs
in less than about 0.3 seconds. Preferably, the inwardly beveled
surface 36 of cutting edge 35 is oriented at an approximately
30.degree. angle.
[0123] The aspiration pressure vacuum is nominally set at 27 in.Hg.
during the cutting stroke. When the cannula is retracted and the
outer lumen 27 is open, the vacuum pressure is reduced to 25 in.Hg.
This aspiration pressure normally allows aspiration of a tissue
sample in less than about 1 second and in most cases in about 0.3
second. In accordance with a most preferred embodiment, the
hydraulic control system 150 preferably is calibrated so that the
inner cannula dwells at its retracted position for about 0.3
seconds to allow complete aspiration of the tissue sample.
Adjusting the return spring 195 of the vacuum switch 194 can
control this dwell rate.
[0124] In a preferred embodiment, the inner cannula 17 can advance
through the cutting stroke in about two seconds. This stroke speed
can be accomplished with a regulated pressure at source 152 of
about 20 p.s.i. When the inner cannula reaches the end of its
cutting stroke, the pressure can increase at about five p.s.i. per
second. Preferably, the return spring 166 of the pressure switch
165 is set so that the end of cutting stroke is sensed within about
0.5 seconds.
[0125] In a modification of the present invention, a tissue biopsy
apparatus 300 is configured as depicted in FIGS. 12-24. As with the
biopsy apparatus 10 of the prior figures, the apparatus 300
includes a cutting element 302 mounted to a user manipulable
handpiece 305. The handpiece includes an upper housing 310, and a
lower housing 311 (see FIG. 13). A cannula hub 312 is mounted to
the handpiece 305 to support the outer cannula 303 of the cutting
element 302 in a fashion similar to that described above. The
biopsy apparatus 300 further includes a filter canister 315 that is
removably mounted to the handpiece 305, again in a manner similar
to that described above.
[0126] In this embodiment, the biopsy apparatus 300 incorporates a
secondary lumen 320 that engages the cannula hub 312. The secondary
lumen 320 can be used to supply a quantity of irrigation fluid or a
measured quantity of air to the cutting element, in a manner
described below. In the illustrated embodiment, the upper housing
310 preferably includes a channel 322 defined along its entire
length. The channel is configured to receive the secondary lumen
320 therein with the lumen recessed within the housing so as to not
interfere with the ability of the surgeon to comfortably grip the
biopsy apparatus 300.
[0127] Referring now to FIG. 13, it can be seen that the biopsy
apparatus 300 includes a reciprocating motor assembly 330 and a
rotary motor assembly motor 332. Each of these assemblies is
constructed similar to the like assemblies described above. In the
present embodiment, the reciprocating motor assembly 330 includes a
housing 340 that is contained within the upper and lower housing
310, 311 that define the handpiece 305.
[0128] The reciprocating motor 334 is similar to the motor
described above. The motor includes a tube fitting 335 for
receiving a hollow tube 337 (see FIG. 13). The tube 337 is
connected to the hydraulic control system 150 depicted in FIG. 10
to provide an alternating supply of pressurized air to the
reciprocating motor 334 in a manner described above.
[0129] As shown in FIGS. 13 and 14, the housing 340 includes a pair
of opposite rails 341, which serve as guides for reciprocation of
the rotary motor 332. As shown in FIG. 17, the rotary motor 332
includes opposite anti-rotation wings 355 that ride along the rails
341 as the motor 332 is reciprocated, and at the same time resist
rotation of the rotary motor 332 during its operation. The rotary
motor 332 further includes a tube fitting 357 that is arranged to
engage a hollow tube 358 (see FIG. 13) which, like the tube 337,
provides a connection to the hydraulic control system 150.
[0130] The housing 340 forms a Luer fitting 345 at its distal end
342, as illustrated in FIG. 16. The Luer fitting includes a
circumferential recess 347 and a number of spaced flanges 348.
Preferably, four such flanges spaced at 90.degree. intervals are
incorporated into the Luer fitting 345. The recess 347 defines an
enlarged gap 349 between one pair of flanges. Moreover, a number of
retention dimples 350 are defined at the base of the
circumferential recess 347, as depicted in FIGS. 14 and 15.
[0131] The Luer fitting 345 is configured to mate with the cannula
hub 312. As shown in FIGS. 18-20, the cannula hub 312 includes a
number of Luer wings 370 corresponding in number to the plurality
of flanges 348. Each of the wings 370 is configured to fit within
the recess the 347 between flanges 348. One of the wings 370
includes an enlargement 371 that prevents the cannula 312 from
being improperly oriented, or more specifically assures a
pre-determined orientation of the tissue receiving opening of the
cannula 312. The enlargement 371 is preferably configured to fit
within the enlarged gap 349 of the Luer fitting 345 to insure an
upward orientation of the cutting element 302, as depicted in FIGS.
12 and 13.
[0132] The bottom surface of the cannula hub 312 defines a number
of protuberances 372. Each of the protuberances is sized to fit
within one of the retention dimples 350 of the Luer fitting 345.
Thus, when the hub is pushed into the recess 347 and rotated, each
of the protuberances 372 engages within a corresponding dimples to
hold the cannula hub 312 in place.
[0133] The cannula hub 312 includes a central bore 376 extending
through the hub. One portion 377 of the bore is sized to tightly
receive the outer cannula 303 of the cutting element 302 as
described with respect to outer cannula 15. Preferably, the outer
cannula 303 is engaged in a substantially fluid tight fit. The hub
312 is configured for removable engagement with the Luer fitting
345 of the handpiece 305 so the entire handpiece can be removed
from the hub 312 while the outer cannula 303 is still in place
within the patient.
[0134] When the handpiece is removed, the inner cutting element 304
is withdrawn from the lumen 306 of the outer cannula, since the
inner cutting element is connected to the reciprocating motor
assembly 334 as described above. Thus, the cannula hub 312 and
outer cannula 302 remain at the surgical site to permit
introduction of medical treatments or other instruments through the
bore 376 and lumen 306. For instance, a local anaesthetic, drug or
treatment material, such as a radioactive pellet, can be introduced
in this manner, before, during or after the biopsy procedure.
Moreover, other surgical instruments, such as a visualization
scope, can be guided to the biopsy site through the hub 312 and
cannula 302.
[0135] The cannula hub 312 also includes a tube fitting 375. The
Tube fitting 375 mates with the secondary lumen 320 that traverses
the outer length of the handpiece 305. The fitting 375 can be of
any suitable configuration for providing a fluid-tight engagement
between the fitting and a tube.
[0136] Referring to back to FIG. 14, the reciprocating motor
assembly motor housing 340 also includes a proximal end 360 that
defines a mounting hub 361. The mounting hub is similar to the hub
98 described above, and is particularly configured to engage the
filter canister 315. As indicated above, the hub and canister
interface can be in the form of a bayonet mount to provide a fluid
tight quick release engagement. The proximal end of the housing 340
defines a circumferential flange 363 that is sealed against the
ends of the upper and lower housings 310, 311 of the handpiece 305.
A pair of tube cutouts 365 are formed at the perimeter of the
flange 363 to provide a passageway for the hydraulic tubes 337 and
358 supplying pressurized fluid to the reciprocating and rotary
motors.
[0137] In order to accommodate the tubes, as well as to firmly
support the working components of the handpiece 305, the upper and
lower housings 310 and 311 can be configured as shown in FIGS.
21-24. In a specific embodiment, the upper housing 310 includes an
interior channel 380 that passes substantially along the entire
length of the interior of the upper housing 310. This interior
channel is aligned with one of the tube cutouts 365 in the flange
363 of the housing 340. This interior channel can provide a pathway
for the tube 358 feeding pressurized fluid to the rotary motor
assembly 332. The upper housing 310 further defines a number of
interior support walls 382. These walls project into the interior
space and serve as a bulkhead for supporting the various working
components of the handpiece 305.
[0138] Likewise, the lower housing 311 includes a number of
interior support walls 385. In addition, near the proximal end 360,
the lower housing 311 can include a longitudinal support rib 387
that preferably is arranged to support the reciprocating motor 334.
At least some of the interior support wall 385 of the lower housing
311 can define tube cutouts 389 to receive the tube 337 feeding
pressurized fluid to the reciprocating motor 334.
[0139] In addition, the lower housing 311 can include a number of
mounting holes 395. These mounting holes can be arranged to permit
mounting of the tissue biopsy apparatus 300 on an existing biopsy
table. In the preferred embodiment of the invention, the biopsy
apparatus 300 can be mounted on a slideable carriage that can be
separately driven to project the cuffing element 302 into the
patient. Support beds of this type are well known and the mounting
feature 395 of the handpiece 305 can be specifically configured to
accommodate any particular support bed.
[0140] Preferably, the upper and lower housings 310, 311 include
interlocking mating edges 397, 398, respectively. In a most
preferred embodiment, the edges include press-fit male/female
interfaces. When all the components are assembled within the
housing 340, the upper and lower housings 310, 311 can be
sandwiched about the housing 340, with the mating edges 397 and 398
in engagement. In one specific embodiment, the engagement can
simply be a removable snap-fit, while in other embodiments, the
engagement can be permanent, such as by the use of an adhesive.
[0141] The tissue biopsy apparatus 300 can be connected to the
hydraulic control system 150 described above. Each of the
components can operate in a manner similar to that described above.
The cannula hub 312 provides a fluid interface for the external
secondary lumen 320 which can be used to introduce a fluid, such as
a saline solution, to the surgical site. In this embodiment, a
saline flush can be contained in a hermetically sealed bag, such as
bag 400 depicted in FIG. 12.
[0142] In one preferred embodiment, a pinch valve 402 can engage
the secondary lumen, preferably adjacent the saline bag 400. The
pinch valve can be opened at the moment that the cutting blade
starts to retract from the cutting opening. The pinch valve 402 can
be controlled to remain open for a pre-determined period of time,
but is preferably closed before the cutting blade advances forward
to make the next biopsy cut. Likewise, the amount of time that the
pinch valve remains open to allow the saline flush to enter the
cutting element 302 can be calibrated based upon a pre-determined
volume of fluid desired at the surgical site. In some procedures,
the pinch valve 402 remains open for 1-2 seconds, although in
certain applications, a shorter time in the range of 0.5 seconds
may be preferred. The valve operation can be calibrated to achieve
a specific fluid volume, such as about 1 cc of saline.
[0143] In one particular embodiment, the hydraulic control system
150 depicted in FIG. 10 can be modified to incorporate a fluid line
branching from the line 192. As described above, the line 192 is
pressurized when the reciprocating motor starts its return stroke.
Pressure in the branch fluid line can be used to open the pinch
valve 402, while a drop in pressure can operate to close the valve.
Alternatively, the pinch valve can be electrically controlled,
again in response to fluid pressure in line 192 which signals the
beginning of the motor return stroke. The closure of the pinch
valve 402 can be dictated by a drop in pressure in line 192 or by
an increase in pressure in line 161, which arises as the
reciprocating motor begins its cutting stroke. It is understood
that while a pinch valve is described, other on-off type fluid
valves can be utilized to control the timing of fluid flow through
the lumen 320 and cannula hub 312.
[0144] Several benefits arise by providing the saline flush. One
primary benefit is that the saline flush can keep the cutting
element clean of blood and tissue that might otherwise clot or jam
the advancement of the inner cutting member. A further benefit is
that the saline can facilitate drawing tissue into the cutting
opening during the cutting cycle. Moreover, the saline flush can
help propel the excised tissue toward the collection canister.
[0145] As an alternative, or an adjunct, the secondary lumen 320
can be used to introduce a puff of air into the cutting element
302. The puff of air, like the saline can be used to keep the
interior channel of the cutting element clean. If properly
pressurized, the introduction of air can prevent blood from flowing
into the cutting element 302 as the cutting member and excise
tissue sample is retracted. Thus, the saline bag 400 can be
replaced with a source of pressurized air. In certain applications,
the air source can provide air pressurized to 3-5 p.s.i.g. As with
the saline flush, the secondary lumen 320 can be closed as the
cutting blade advances to remove a tissue sample, and opened as the
blade starts to retract. The pressurized air will pass around the
outside of the inner cutting blade toward the opening at the end of
the cutting element 302. The pressure of this puff of air can be
calibrated as necessary to counteract the blood pressure at the
surgical site and keep the blood from flowing into the cutting
element 302.
[0146] The tissue biopsy apparatus 10 or 300 described above
provides significant advantages over prior biopsy devices. One
significant benefit is that the apparatus of the present invention
is completely closed. This feature means that no fluid, such as
blood, can escape or leak from the biopsy apparatus 10 or 300. In
prior devices, the each extracted tissue sample is drawn into a
removable opening that is open to the atmosphere. The present
invention does not include any component that is open to the
atmosphere, with the exception of the secondary lumen 320 which is
controllably open to atmosphere to keep the aspiration passageway
open and clean. The present invention provides a system for
repeatably and precisely withdrawing uniformly sized biopsy
samples. With each stroke of the cutting blade, a uniformly
dimension biopsy sample is withdrawn and pulled into the collection
canister at the proximal end of the apparatus. Thus, the biopsy
apparatus 10 and 300 of the present invention can readily remove an
entire lesion or region of suspect tissue. This is a significant
improvement over prior devices that are only capable of extracting
a limited quantity of tissue for biopsy evaluation only.
[0147] While the invention has been illustrated and described in
detail in the drawings and foregoing description, the same is to be
considered as illustrative and not restrictive in character. It
should be understood that only the preferred embodiments have been
shown and described and that all changes and modifications that
come within the spirit of the invention are desired to be
protected.
EXAMPLES
Example 1
[0148] Eighteen trial biopsies were performed upon patients after
obtaining informed consent and preparing the patients according to
standard biopsy procedures. In each case, biopsies were performed
according to the following procedure. The patient was positioned on
her back on the surgical table, and the lesion was located using
ultrasound. A small incision was made in the breast. While viewing
the lesion using ultrasound, an early embodiment of the present
invention was inserted into the breast with the tissue receiving
opening adjacent the lesion. The cutter was engaged to sample
and/or remove the lesion. The lesions varied in size from 6-22 mm.
The surgeon's comments are provided in Table 1.
[0149] 1TABLE 1 Surgeon's Comments Regarding the Use of Early
Embodiments of the Present Biopsy Device Trial Number Surgeon's
Comments 1 Went very well, lesion took approximately 50 seconds to
go away 2 Large fatty breast, very difficult to get needle to mass;
eventually successfully removed 3 Successfully removed without
problems 4 Went very well; lesion gone in 4-5 cores 5 Two lesions
attempted (1) lesion easily removed, (2) inner cutter was riding up
and catching the opening 6 Only took 4-5 cores to disappear 7
Started getting good cores, then stopped cutting due to secondary
electrical break 8 Lesion appeared to be totally gone, cores were
up to 25 mm in length 9 Only got 4-5 good cores, then stopped
cutting due to inner cutter riding up 10 No problems 11 No problems
at all 12 Lesion was easily palpable but very mobile which made
access difficult. Used tactile sensation to manipulate tumor into
aperture which worked very well; very good cores; Took 4.5 minutes
but many of the cores were fatty as a lot of the time I was missing
the lesion before realizing that palpitation was better 13 Took 3-4
cores then quit cutting, blade was dulled, probably due to
deflection of tip downward 14 Went very well, no problems 15 Went
well, no problems 16 Went well, no problems 17 Went very well 18
Went very well, the suction tubing collapsed, need stronger tubing;
filter did fill up requiring stopping to empty, might need larger
filter.
[0150] Table 1 illustrates the success of the present invention in
its early stage of development. A majority of the trials, trials
1-6, 8, 1-12, and 14-18, resulted in a successful removal of the
lesion with little to no problems. Lesions were removed quickly
and, in some cases, only a few cores were required (see trials 1,
4, and 6). In trial number 8 it was noted that the cores were up to
25 mm in length.
[0151] In some trials, the surgeon experienced difficulties
removing the lesion because the inner cutting blade would ride up
and catch on the tissue receiving opening (see trials 5, and 9).
However, this problem has been resolved in the present invention by
integrating a crimp in the outer cannula. The crimp forms a dimple
that protrudes from the inner surface of the cannula and into the
outer lumen. As the inner cannula passes the dimple, the dimple
forces the inner cannula away from the tissue-receiving opening and
prevents the inner cannula from riding up into the opening. In a
further embodiment, the cutting edge of the inner cannula is
inwardly beveled. This inwardly beveled surface also helps
eliminate risk of catching by guiding the inner cannula back into
the hollow outer cannula. In addition, to prevent the deflection of
the tip downward, as noted in trial 13, a stiffening element is
provided on the outer cannula opposite the tissue-receiving
opening.
Example 2
[0152] Surgeons performing biopsies using the device of this
invention and a device having the features of U.S. Pat. No.
5,526,822 to Burbank provided feedback as to the efficiency of each
device. The surgeons' input was used to calculate the amount of
time and the number of strokes necessary to remove a lesion. Table
2 compares the amount of time and the number of strokes necessary
to remove comparable lesions using each device.
[0153] 2TABLE 2 Comparison of Removal Times and Number of Strokes
of the Present Biopsy Device with the Prior Art Device Present
Biopsy Device Prior Art Removal Times (sec) Lesion Diameter 10 80
500 13 135 845 16 205 1280 No. of Strokes Lesion Diameter 10 16 25
13 27 42 16 41 64.
[0154] This data demonstrates that the present tissue biopsy
apparatus consistently removes a lesion with fewer strokes and in
less time than the prior cutter. The present tissue biopsy device
performs 80% faster than the prior cutter, which ultimately results
in reduced trauma to the tissue.
CONCLUSION
[0155] The biopsy devices of this invention reliably, quickly and
efficiently sample and remove lesions in tissue.
* * * * *