U.S. patent application number 11/172557 was filed with the patent office on 2005-10-27 for surgical biopsy device having a flexible cutter.
Invention is credited to Huitema, Thomas W..
Application Number | 20050240118 11/172557 |
Document ID | / |
Family ID | 25426377 |
Filed Date | 2005-10-27 |
United States Patent
Application |
20050240118 |
Kind Code |
A1 |
Huitema, Thomas W. |
October 27, 2005 |
Surgical biopsy device having a flexible cutter
Abstract
A biopsy probe for the collection of at least one soft tissue
sample from a surgical patient. The biopsy probe has a frame and an
elongated piercing element having a proximal end attached to the
distal end of the frame and a sharpened distal end for piercing
tissue. The piercing element has a lumen extending at least
partially therethrough. The probe also includes an elongated cutter
disposed coaxially and slidably within the lumen of the piercing
element. The cutter has a distal end for cutting a tissue sample, a
proximal end and a body connecting the distal and proximal ends,
wherein at least a portion of the body comprises a flexible
member.
Inventors: |
Huitema, Thomas W.;
(Fremont, CA) |
Correspondence
Address: |
PHILIP S. JOHNSON
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
25426377 |
Appl. No.: |
11/172557 |
Filed: |
June 30, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11172557 |
Jun 30, 2005 |
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09908893 |
Jul 19, 2001 |
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6942627 |
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Current U.S.
Class: |
600/566 ;
600/568; 606/167 |
Current CPC
Class: |
A61B 2010/0225 20130101;
A61B 10/0283 20130101; A61B 2010/0208 20130101; A61B 10/0275
20130101 |
Class at
Publication: |
600/566 ;
600/568; 606/167 |
International
Class: |
A61B 010/00; A61B
017/32 |
Claims
1-21. (canceled)
22. A biopsy device comprising: an elongated piercing element
having a closed distal tip, a proximal end, and a lumen extending
at least partially through the elongated piercing element; and an
elongated cutter having a first part disposed within the lumen of
the elongated piercing element, and a second part of the cutter
extending proximally from the proximal end of the elongated
piercing element, wherein at least a portion of the second part of
the cutter extending proximally from the elongated piercing element
is flexible for taking on a curved shape.
23. The biopsy device of claim 22 wherein at least a portion of the
second part of the cutter is disposed within a curved
passageway.
24. The biopsy device of claim 22 wherein a portion of the
elongated cutter extends along an arcuate path.
25. The biopsy device of claim 22 wherein a portion of the
elongated cutter follows a nonlinear path through an arc of at
least about 90 degrees.
26. The biopsy device of claim 22, wherein the cutter is rotatable
and translatable within the elongated piercing element.
27. The biopsy device of claim 22 wherein the elongated piercing
element comprises a lateral tissue receiving port, wherein the
elongated cutter has a distal cutting end supported for generally
straight line travel past the lateral tissue receiving port, and
wherein the elongated cutter takes on a nonlinear curvature
proximal of the lateral tissue receiving port.
28. A medical device for obtaining a tissue sample, the device
comprising: a generally straight, elongated piercing element having
a proximal end, a closed distal end with a piercing tip for
piercing tissue, a generally straight lumen, and a lateral tissue
receiving port spaced proximally of the closed distal end and
communicating with the lumen; an elongated cutter having a proximal
end, a distal end for cutting tissue, and a body connecting the
distal and proximal ends, wherein the distal end of the cutter is
positionable within the lumen of the piercing element, wherein the
cutter extends proximally from the lumen of the piercing element,
and wherein at least a portion of the cutter extending proximally
from the lumen of the piercing element is flexible and capable of
taking on a curved shape; and a member disposed proximally of the
proximal end of the elongated piercing element, the member having a
curved passageway therein for receiving a flexible portion of the
cutter.
Description
FIELD OF THE INVENTION
[0001] The present invention relates, in general, to devices for
tissue sampling and, more particularly, to improved biopsy probes
for acquiring subcutaneous biopsies and for removing lesions.
BACKGROUND OF THE INVENTION
[0002] The diagnosis and treatment of patients with cancerous
tumors, pre-malignant conditions, and other disorders has long been
an area of intense investigation. Non-invasive methods for
examining tissue are palpation, X-ray, MRI, CT, and ultrasound
imaging. When the physician suspects that a tissue may contain
cancerous cells, a biopsy may be done either in an open procedure
or in a percutaneous procedure. For an open procedure, a scalpel is
used by the surgeon to create a large incision in the tissue in
order to provide direct viewing and access to the tissue mass of
interest. Removal of the entire mass (excisional biopsy), or a part
of the mass (incisional biopsy) is done. For a percutaneous biopsy,
a needle-like instrument is used through a very small incision to
access the tissue mass of interest and to obtain a tissue sample
for later examination and analysis. The advantages of the
percutaneous method as compared to the open method are significant:
less recovery time for the patient, less pain, less surgical time,
lower cost, less risk of injury to adjacent bodily tissues such as
nerves, and less disfigurement of the patient's anatomy. Use of the
percutaneous method in combination with artificial imaging devices
such as X-ray and ultrasound has resulted in highly reliable
diagnoses and treatments.
[0003] Generally there are two ways to obtain percutaneously a
portion of tissue from within the body, by aspiration or by core
sampling. Aspiration of the tissue through a fine needle requires
the tissue to be fragmented into small enough pieces to be
withdrawn in a fluid medium. The method is less intrusive than
other known sampling techniques, but one can only examine cells in
the liquid (cytology) and not the cells and the structure
(pathology). In core biopsy, a core or fragment of tissue is
obtained for histologic examination which may be done via a frozen
or paraffin section. The type of biopsy used depends mainly on
various factors present in the patient, and no single procedure is
ideal for all cases. Core biopsy, however, is very useful in a
number of conditions and is widely used by physicians.
[0004] A number of biopsy devices for use in combination with
artificial imaging devices are known in the field. An example of a
core biopsy device using an artificial imaging system is described
in U.S. Pat. Nos. 4,699,154, 4,944,308, and U.S. Pat. No. Re.
34,056. However, these types of spring-powered devices must
re-puncture the breast or organ each time a sample is taken. An
example of an aspiration device using an artificial imaging system
is described in the following U.S. Pat. No.: 5,492,130 issued to
Chiou on Feb. 20, 1996; U.S. Pat. No. 5,526,821 issued to Jamshidi
on Jun. 18, 1996; U.S. Pat. No. 5,429,138 issue to Jamshidi on Jul.
4, 1995; and U.S. Pat. No. 5,027,827 issued to Cody, et al, on Jul.
2, 1991.
[0005] Operator error can often be an issue with the above
described devices. In addition there was a need for a device which
could enable multiple sampling of the tissue without having to
re-puncture the tissue for each sample. An example of such a
product is described in U.S. Pat. No. 5,526,822 issued to Burbank,
et al, on Jun. 18, 1996, which is hereby incorporated herein by
reference. The Burbank et al. instrument is a type of image-guided,
percutaneous, coring, breast biopsy instrument. It is
vacuum-assisted, and some of the steps for retrieving the tissue
samples have been automated. The physician uses this device to
capture "actively" (using the vacuum) the tissue prior to severing
it from the body. This allows for sampling tissues of varying
hardness. The device can also be used to collect multiple samples
in numerous positions about its longitudinal axis, and without
needing to remove the device from the body. These features allow
for substantial sampling of large lesions and complete removal of
small ones. In the medical arts the instrument is commonly known as
MAMMOTOME.TM..
[0006] Numerous improvements to the Burbank et al. device have been
described in co-pending and commonly assigned U.S. application Ser.
No. 08/825,899, filed on Apr. 2, 1997, the disclosure of which is
hereby incorporated herein by reference. This reference describes
numerous improvements to the original invention including a molded
tissue cassette housing which permits the handling and viewing of
multiple tissue samples without physical contact by the instrument
operator. Another improvement to the original device includes the
interconnection of the housing to the piercing needle by a
thumbwheel which permits the needle to rotate relative to the
housing, thereby preventing the vacuum tube from wrapping about the
housing.
[0007] Other improvements to the above described device are
disclosed in U.S. Pat. No. 6,007,497 issued to Huitema on Dec. 28,
1999, which is hereby incorporated herein by reference. This
reference describes improvements to the fluid management
capabilities of the system, resulting in part from the addition of
sealing elements located in critical areas of the biopsy probe.
[0008] In actual clinical use for breast biopsy, the MAMMOTOME
instrument (probe and driver assembly) is mounted to the three axis
positioning head of an x-ray imaging machine. The three axis
positioning head is located in the area between the x-ray source
and the image plate. The x-ray machines are outfitted with a
computerized system which requires two x-ray images of the breast
be taken with the x-ray source at two different positions in order
for the computer to calculate the x, y and z axis location of the
suspect abnormality. In order to take the stereo x-ray images the
x-ray source must be conveniently movable. The x-ray source
therefore is typically mounted to an arm which, at the end opposite
the x-ray source, is pivotally mounted to the frame of the machine
in the region of the image plate.
[0009] To image the breast, the breast is placed between the x-ray
source and the image plate, the breast being placed on the image
plate. In order to take the necessary stereo images the clinician
will manually position the x-ray source to one side and then the
other of the center axis of the machine (typically 15-20 degrees to
each side of the center axis), obtaining an x-ray image on each
side of the breast. The computer will then, with great accuracy,
calculate the precise x, y and z location of the suspect
abnormality in the breast and automatically communicate to the
clinician or directly to the positioning head the targeting
coordinates for the biopsy device. The clinician can then manually,
or automatically, position the biopsy probe into the breast at the
precise location of the abnormality.
[0010] There are generally two styles of x-ray machines in wide
spread use for breast imaging. One style is known as "prone",
because the patient lies face down during the x-ray and biopsy
procedures on a table that is configured horizontal to the floor.
The other style, in more wide spread use, is the "upright". The
center axis of the upright imaging machine is configured vertical
to the floor and the patient sits in front of the machine during
the x-ray and biopsy procedures.
[0011] The above described biopsy instruments mount to a three axis
positioning head located between the x-ray source and image plate
on the breast x-ray imaging machine. The distance between the x-ray
source and imaging plate is known in the industry as the SID
(Source to Image Distance). There is no standard SID in the
industry and in fact the SID varies greatly from one x-ray machine
manufacturer to another.
[0012] This creates a problem for the manufacturers of devices,
like the MAMMOTOME, which is intended to be mounted between the
x-ray source and image plate of the x-ray imaging machine. In the
case of the MAMMOTOME instrument with its length from the distal
tip of the biopsy probe to the most proximal portion of the driver
measuring approximately 41 centimeters, adequate mounting space has
been found to exist on the prone style x-ray machines. However, on
some of the more popular upright style x-ray imaging machines the
SID has been found to be as little as 29 centimeters, obviously too
small in which to mount the MAMMOTOME. What is needed, therefore,
is a biopsy instrument configured to permit mounting on the shorter
SID x-ray imaging machines.
SUMMARY OF THE INVENTION
[0013] In accordance with the present invention, there is provided
a biopsy probe for the collection of at least one soft tissue
sample from a surgical patient. The biopsy probe has a frame and an
elongated piercing element having a proximal end attached to the
distal end of the frame and a sharpened distal end for piercing
tissue. The piercing element has a lumen extending at least
partially therethrough. The probe also includes an elongated cutter
disposed coaxially and slidably within the lumen of the piercing
element. The cutter has a distal end for cutting a tissue sample, a
proximal end and a body connecting the distal and proximal ends,
wherein at least a portion of the body comprises a flexible
member.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The novel features of the invention are set forth with
particularity in the appended claims. The invention itself,
however, both as to organization and methods of operation, together
with further objects and advantages thereof, may best be understood
by reference to the following description, taken in conjunction
with the accompanying drawings in which:
[0015] FIG. 1 is an isometric view of a biopsy apparatus, showing
the biopsy probe of FIG. 2, its insertion into a driver, and
schematic representations of a control unit, vacuum sources, and
three axis positioning head;
[0016] FIG. 2 is an isometric view of a biopsy probe of the present
invention;
[0017] FIG. 3 is an exploded isometric view of the biopsy probe of
FIG. 2;
[0018] FIG. 4 is an isometric view of a probe frame of the biopsy
probe of FIG. 2;
[0019] FIG. 5 is a longitudinal sectional view of the probe frame
of FIG. 4 illustrating the internal structures assembled into its
distal and proximal ends.
DETAILED DESCRIPTION OF THE INVENTION
[0020] As best shown in FIG. 1, the present invention is a surgical
biopsy apparatus 12 for a minimally invasively acquiring repeated
subcutaneous biopsies. In the present invention, surgical biopsy
apparatus 12 generally comprises a probe 10 for insertion within a
surgical patient for extraction of a tissue sample therefrom.
Apparatus 12 further includes a powered probe driver 100, a three
axis positioning head 98, a control unit 96, and a first and second
tube in fluid communication with a first, and second reservoir,
respectively. In the preferred embodiment, reservoirs 90 and 94 are
connected to at least one vacuum source. Probe 10 of surgical
biopsy apparatus 12 is removably mounted to powered probe driver
100. The elements shown schematically as boxes in FIG. 1 are well
known in the art and are described in the herein incorporated
references.
[0021] Driver 100 is well known in the art and includes a housing
109 having a moveable cover 108 hingedly attached thereto. Within
housing 109 there is a housing mount fork 102 for receiving probe
10. Housing 109 also included a cutter advance fork 112 for
positioning cutter gear 59, and an elongated driver gear 106 to
mate with and rotate cutter 50. Driver 100 is attached to a three
axis positioning head 98 which is connected to an x-ray imaging
machine having a stereotactic guidance system (not shown). This
positioning/guidance system is for moving probe 10 and driver 100
so that the apparatus pierces the tissue at the correct location in
order to sample the target lesion. Housing 109 also has a cutter
advance knob 113 which is manually actuated to obtain the tissue
sample. This feature will be discussed in greater detail below.
[0022] Control unit 96 is used to control the sequence of actions
performed by surgical biopsy apparatus 12 in order to obtain the
biopsy sample from a surgical patient. As will be appreciated by
those skilled in the art, and as discussed in the hereinbefore
incorporated references, control unit 96 preferably controls the
application of a vacuum to probe 10, and controls the activation of
the cutter motor (not shown) within driver 100.
[0023] Attention is now drawn to FIG. 2 which is an isometric view
of the preferred embodiment of probe 10. Probe 10 is a coaxial
assembly of three elongated elements: a piercer 20, a cutter 50,
and a tissue remover 60. Tissue remover 60 moves slideably within
cutter 50 which, in turn, moves slideably within frame 40 and
piercer 20. Cutter 50 and tissue remover 60 contain flexible
elements, as will be described later. Probe 10 generally is used as
follows: The skin of a surgical patient is disinfected. A local
anesthetic such as lidocaine hydrochloride is injected by
hypodermic needle into the tissue. A small incision is made in the
skin of the surgical patient. Then piercer 20 is placed into that
incision and pierced into the tissue of the surgical patient.
Piercer 20 is advanced to the tissue area of interest by the
movement of three axis positioning head 98. During this step cutter
50 is completely advanced in its distal direction. Once the tissue
of interest is accessed by piercer 20, cutter 50 is partially
retracted in the proximal direction and the tissue to be extracted
is drawn by vacuum into port 26 on distal end 22 of probe 10.
Cutter 50 is then actuated by the cutter motor of driver 100 and
manually advanced distally using cutter advance knob 113. This
severs the tissue sample captured in distal end 22 of probe 10.
Afterwards, cutter 50 is manually retracted in the proximal
direction, transporting the tissue sample to outside the patient's
body. Tissue remover 60 then releases or "knocks-out" the tissue
sample from cutter 50, so that the tissue sample may be retrieved
for analysis.
[0024] Referring to FIGS. 2 through 4, piercer 20 includes a frame
40 which may be made from a rigid, medical grade plastic. Frame 40
is generally arcuate in shape, forming an arc of approximately
ninety degrees in the preferred embodiment, and may be more or less
as may be dictated by the mounting needs for the x-ray imaging
machine. Frame 40 has a distal end 48 and a proximal end 49. Frame
hole 45 (See FIG. 5) extends longitudinally through frame bushing
46 communicating between the distal end 48 and proximal end 49 of
frame 40. A pair of mounting fins 44 are located on proximal end 49
of frame 40. Mounting fins 44 are removably inserted into a
mounting fork 102 of driver 100 as depicted in FIG. 1, thus
anchoring probe 10 to driver 100.
[0025] Teeth 38, which comprise a plurality of raised ribs, and
marker 39, a single raised rib, are located at the distal end 48 of
frame 40 and interface with positioning wheel 30, which will be
described in more detail later. Tissue sampling surface 47 at the
distal end 48 of frame 40 is where a tissue sample extracted from
within the surgical patient is removed from probe 10.
[0026] Tubular piercing element 25 is well known in the art and has
a proximal end 24 and a distal end 22 and is rotatably attached to
the proximal end 48 of frame 40 by a hub 2 (See FIG. 5) and a
positioning wheel 30. Piercing element 25 is preferably made from
plastic or stainless steel and includes an upper lumen 21 and a
lower lumen 23. Rectangular port 26 on distal end 22 of piercing
element 25 is located on upper lumen 21 and is provided for
receiving the tissue that is to be extracted from the surgical
patient. Rotation of positioning wheel 30 by the surgeon allows
positioning of rectangular port 26 in distal end 22 of piercer 20.
A positional indicator 31 on wheel 30 may be referenced to a marker
39 on frame 40 of probe 10. By changing the position of port 26,
the surgeon may access tissue from anywhere around distal end 22 of
piercer 20. Piercing tip 28 is attached to distal end 22 of
piercing element 25 and pierces into the tissue of the surgical
patient. Piercer 20 further comprises a lower lumen 23 which has a
plurality of small holes (not shown) in distal end 22 for the
communication of port 26 to first reservoir 90. In the present
embodiment, this first reservoir is a vacuum source so that the
prolapse of tissue into port 26 is greatly enhanced.
[0027] A plurality of teeth 38 are located around the periphery of
distal end 48 of frame 40. Teeth 38 are for interaction with flutes
32 (not shown) of positioning wheel 30 (see FIG. 1) so that a
tactile feedback is provided to the user while adjusting the
location of port 26 on distal end 22 of piercer 20. In addition to
the tactile feedback, teeth 38 are a holding means for the
orientation of port 26, and also a referencing means. That is, the
surgeon may count the number of "detents" felt when rotating
positioning wheel 30, while looking at the relationship between
positional indicator 31 on wheel 30 and marker 39 on frame 40, in
order to understand the radial orientation of port 26 on distal end
22 of piercer 20.
[0028] Now referring again to FIGS. 1 and 3, cutter 50 comprises a
distal end 52, a proximal end 58, and a flexible member extending
therebetween. Cutter 50 further comprises a cutter shank 56 having
a distal end 57 fixedly attached to a proximal end 54 of a hollow
flexible cutter tube 53. Flexible cutter tube 53 can be made of PVC
or any other flexible thermoplastic polymer or a superelastic alloy
such as nitinol. In an alternate embodiment flexible cutter tube 53
is made of a tubular shape constructed of wound stainless steel
wire, similar to a compression spring. A longitudinal passage
through cutter shank 56 (not visible) communicates with a
longitudinal passage through flexible cutter tube 53. On the distal
end of cutter 50 is a cutter blade 51. Cutter blade 51 has a distal
end 65 and proximal end 66. Cutter blade 51 is preferably made by
the sharpening of the circumference of distal end 65 of cutter
blade 51, which is preferably made of a stainless steel. Proximal
end 66 of cutter blade 51 is fixedly attached to distal end 67 of
flexible cutter tube 53. A longitudinal passage through cutter
blade 51 communicates with a longitudinal passage through flexible
cutter tube 53. On proximal end 58 of cutter 50 is a cutter gear
59, which is preferably integrally molded with cutter shank 56. A
proximal cutter seal 114 is attached to the most proximal end of
cutter 50.
[0029] Cutter gear 59 is for operational engagement with an
elongated gear 106 of driver 100. When probe 10 is inserted into
driver 100, cutter gear 59 is positioned into cutter advance fork
112 of the driver. Cutter advance fork 112 is attached to cutter
advance knob 113 so that movement of knob 113 causes the like
movement of cutter 50. Cutter 50 reciprocates axially within upper
lumen 21 of piercer 20 as the surgeon manually operates advancing
knob 113. As cutter 50 is moved distal and proximal by operation of
cutter advance knob 113, cutter gear 59 moves along elongated gear
106 of driver 100, while maintaining operational engagement. The
electric motor (not shown) of the driver rotates cutter 50 at a
high rate of speed.
[0030] As best illustrated in FIG. 3, tissue remover 60 comprises a
remover tube 63, which has a proximal end 64, a distal end 62, and
a longitudinal axis extending therebetween. Tissue remover 60
slides freely through proximal cutter seal 114. On proximal end 64
of remover tube 63 is attached a valve 70 having a distal end 72, a
proximal end 74 which contains a Luer connector, and a passageway
therethrough. Valve 70 provides for the flow of air and fluids from
tissue remover 60 to second reservoir 94 via second tube 95 and a
connector 97 (see FIG. 1). Remover tube 63 is hollow and in the
present embodiment made of flexible PVC or other flexible
thermoplastic resin. In an alternate embodiment, since remover tube
63 is held fixed with reference to probe frame 40, remover tube 63
is made of a rigid material such as stainless steel and pre-formed
in an arcuate shape to match the arc of probe frame 40. A distal
tip 61 (also referred to simply as a structure) on distal end 62 of
remover tube 63 is configured so as to allow the passage of air and
fluids and to block the passage of tissue particles larger than
what may pass through tissue remover 60 and valve 70. Distal tip 61
prevents the loss of tissue into the reservoir, which may otherwise
be collected for pathological analysis. The length of remover tube
63 is such that when cutter 50 is retracted to the first position,
distal tip 61 of remover tube 63 is approximately adjacent to
cutter blade distal end 65 of cutter blade 51. This arrangement
allows the tissue sample retrieved in distal end 52 of cutter 50 to
be forced out of the same by distal tip 61 of tissue remover 60
when cutter 50 is retracted to the first position. The tissue
sample may then drop onto tissue sample surface 47 of probe 10.
[0031] Referring now to FIG. 5, flexible cutter tube 53 fits
closely yet slides freely in frame hole 45 which extends
longitudinally through frame bushing 46 of piercer 20. When cutter
50 is retracted to its most proximal position, cutter blade 51 of
cutter 50 is approximately adjacent to frame surface 82 of piercer
20 so as to allow free access to sampling surface 47 (See FIG. 4)
for retrieval of the tissue sample.
[0032] Distal frame seal 1 is shown assembled into distal end 48 of
frame 40 and rotatably supports proximal end 24 of piercing element
25. Distal frame seal 1 comprises hub 2 and a first O-ring 120 and
a second O-ring 121. Hub 2 further comprises a hub step 19, wherein
hub step 19 is a supporting means for positioning wheel 30 (see
FIG. 3). A first radial space 122, which is occupied by part of
distal frame seal 1, is defined by the radial clearance between
piercer 20 (partially shown) and proximal end 48 of frame 40. A
lower lumen vacuum boss 41 is in alignment between two O-rings 120
and 121 so as to allow vacuum to be delivered through passages 35
and into opening 6 of distal frame seal 1. First tube 91 (see FIG.
1) from first reservoir 90 is a flexible, medical grade tube which
may fit tightly over vacuum boss 41. Proximal end 24 of lower lumen
23 of piercing element 25 is inserted into opening 6 of distal
frame seal 1 so that the vacuum may be delivered through lower
lumen 23 and to port 26 on distal end 22 of piercer 20.
[0033] Proximal frame seal 11 is shown assembled into proximal end
49 of frame 40 and is held in position by a protrusion projecting
into hole 36 in frame 40. The proximal frame seal occupies a second
radial space 124 defined by the clearance between flexible cutter
tube 53 and proximal end 49 of frame 40. Proximal frame seal 11
substantially prevents the flow of fluids through the second radial
space.
[0034] It should be noted that second reservoir 94 is a vacuum
source which facilitates the removal of the fluids from within
probe 10, and which facilitates the transport of the tissue sample
from port 26 to tissue sampling surface 47 (see FIG. 1). Because
tissue remover 60 is inserted within cutter 50 which is inserted in
upper lumen 21 of piercer 20, the vacuum source is connected to
upper lumen 21 as well and assists in drawing tissue into port 26
prior to cutting of the tissue by cutter blade 51. In addition to
the removal of fluids from probe 10, the vacuum provides a means of
releasably attaching the tissue sample to the end of tissue remover
60 so that once severed, the sample may be held in distal end 52 of
flexible cutter tube 53 and transported from port 26 of piercer 20
to outside the patient's body to tissue sampling surface 47 of
probe 10.
[0035] While preferred embodiments of the present invention have
been shown and described herein, it will be obvious to those
skilled in the art that such embodiments are provided by way of
example only. Numerous variations, changes, and substitutions will
now occur to those skilled in the art without departing from the
invention. Accordingly, it is intended that the invention be
limited only by the spirit and scope of the appended claims.
* * * * *