U.S. patent application number 15/816856 was filed with the patent office on 2022-02-24 for tissue removal device and method of use.
The applicant listed for this patent is MERIT MEDICAL SYSTEMS, INC.. Invention is credited to Robert Bilgor PELIKS.
Application Number | 20220054112 15/816856 |
Document ID | / |
Family ID | |
Filed Date | 2022-02-24 |
United States Patent
Application |
20220054112 |
Kind Code |
A9 |
PELIKS; Robert Bilgor |
February 24, 2022 |
TISSUE REMOVAL DEVICE AND METHOD OF USE
Abstract
A biopsy device for acquiring a tissue sample is disclosed. The
biopsy device comprises a tissue-engaging outer element, a handle
and a trocar. Multiple tissue samples may be collected.
Inventors: |
PELIKS; Robert Bilgor; (San
Francisco, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MERIT MEDICAL SYSTEMS, INC. |
SOUTH JORDAN |
UT |
US |
|
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20180092633 A1 |
April 5, 2018 |
|
|
Appl. No.: |
15/816856 |
Filed: |
November 17, 2017 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
PCT/US2016/035138 |
Jun 1, 2016 |
|
|
|
15816856 |
|
|
|
|
62326785 |
Apr 24, 2016 |
|
|
|
62169888 |
Jun 2, 2015 |
|
|
|
International
Class: |
A61B 10/02 20060101
A61B010/02 |
Claims
1. A tool for acquiring a tissue comprising: a cutter tube for
receiving the tissue; a partoff mechanism at least partially inside
of the cutter tube; a trocar slidably positioned inside of the
cutter tube; a handle having a tubular longitudinal axis, wherein
the handle is longitudinally fixed to the cutter tube; wherein the
trocar has a first trocar position and a second trocar position,
wherein in the first trocar position the trocar is in a distal-most
position in the cutter tube, and wherein in the second trocar
position, the trocar is proximal to the first trocar position, and
the tissue is in the cutter tube, and the tissue is in contact with
a distal terminal end of the trocar, and wherein the proximal end
of the trocar extends into the handle, and wherein the proximal end
of the trocar is distal to the proximal terminal end of the
handle.
2. The tool of claim 1, wherein the cutter tube is configured to
rotate about the tubular longitudinal axis with respect to the
handle.
3. A method for acquiring tissue comprising: receiving the tissue
in the distal end of a cutter tube, wherein a trocar is slidably
positioned in the cutter tube, and wherein receiving the tissue
comprises pressing the tissue against the distal end of the trocar,
and wherein the pressing comprises sliding the trocar
proximally.
4. The method of claim 3, further comprising inserting the cutter
tube into a tissue site.
5. The method of claim 3, further comprising ejecting the tissue
from the distal end of the cutter tube.
6. The method of claim 5, wherein ejecting comprises sliding the
trocar distally in the cutter tube.
7. A tool for acquiring a tissue comprising: a cutter tube for
receiving the tissue; and; an indicator configured to indicate the
amount of tissue in the cutter tube.
8. The tool of claim 7, wherein the indicator comprises a first
indicator length extending out of the cutter tube, and wherein the
first indicator length corresponds to the length of the tissue in
the cutter tube.
9. The tool of claim 7, wherein the indicator comprises a
trocar.
10. The tool of claim 7, wherein a partoff mechanism is located
adjacent to the cutter tube.
11. The tool of claim 10, wherein the partoff mechanism is
configured to sever the tissue.
12. The tool of claim 7, further comprising a handle having a
tubular longitudinal axis, wherein the cutter tube is configured to
rotate about the tubular longitudinal axis with respect to the
handle.
13. The tool of claim 12, wherein the indicator is configured to
rotate with respect to the handle.
14. The tool of claim 12, wherein the indicator is configured to be
rotationally fixed with respect to the handle.
15. The tool of claim 7, wherein the cutter tube is longitudinally
fixed with respect to the handle.
16. The tool of claim 7, wherein the indicator is configured to
eject the tissue from the cutter tube.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application Nos. 62/169,888 filed on Jun. 2, 2015 and 62/326,785
filed on Apr. 26, 2016, which are both incorporated by reference
herein in their entireties.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] This disclosure relates to medical instrumentation. More
particularly, a tool used for acquiring tissue and a method for
using the same are disclosed.
Description of the Prior Art
[0003] A number of medical procedures require the removal of tissue
samples from a patient. These operations can range from the removal
of suspicious tissue, as in the biopsy of a cancerous lesion, to
cell harvesting, as in a bone marrow donation. A number of
different biopsy tools are used for retrieving these tissue samples
from patients. There are two main styles of core biopsy tools--side
cutting and forward coring. One style of biopsy tool may be called
forward coring. A forward coring biopsy tool may include a spinning
cannula with a razor edge. As the device is advanced into a tissue
mass, the cannula may core the tissue. The cored tissue sample must
then be parted off from the remaining tissue mass. There are a
number of methods for parting off the tissue sample, such as
tearing or cutting.
SUMMARY OF THE INVENTION
[0004] A tool used to obtain tissue samples is disclosed herein.
The partoff mechanism of the tool can be comprised of at least one
tubular element. The tubular element may be spun along a central
axis. The distal end of the tubular element may comprise a flexible
partoff tab. The angle of this partoff tab may be adjusted during
use. For example, the partoff tab may be flush with the remainder
of the tube wall while advancing the device into a mass of tissue
& while coring a tissue sample; the partoff tab may be angled
inwards to partoff the sample from the tissue mass. The tube may be
spinning as the partoff tab is repositioned; if the tube is
spinning, the partoff tab may cut the tissue mass as it is being
repositioned. The partoff tab may remain positioned inwards to
secure the samples within the tubular element (e.g. the partoff tab
may prevent the samples from falling out of the terminal distal end
of the tubular element).
[0005] A tool for acquiring tissue is disclosed. The tool can have
a cutter tube comprising a tubular system and a partoff tab. The
partoff tab may have a partoff tab first end and a partoff tab
second end. The partoff tab first end can be secured to the tubular
system. The partoff tab second end can be secured to the tubular
system. The cutter tube can have a tubular longitudinal axis. The
partoff tab can have a longitudinally expanded configuration and a
longitudinally contracted configuration. The length of the partoff
tab along the tubular longitudinal axis in the longitudinally
expanded configuration may be longer than the length of the partoff
tab in the longitudinally contracted configuration.
[0006] A tool for acquiring tissue may be comprised of a cutter
tube, a partoff tab having a partoff tab first and second ends and
an actuator. The partoff tab first end can be secured to the cutter
tube. The partoff tab second end can be secured to the actuator.
The length of the partoff tab along the tubular longitudinal axis
in the longitudinally expanded configuration may be longer than the
length of the partoff tab in the longitudinally contracted
configuration.
[0007] A tool for acquiring tissue may comprise a cutter tube. The
cutter tube may comprise the tubular system and the partoff tab.
The length of the partoff tab along a tubular longitudinal axis in
the longitudinally expanded configuration may be longer than the
length of the partoff tab in the longitudinally contracted
configuration. The partoff tab can have two flex points, when in
the contracted configuration.
[0008] A tool for acquiring tissue may comprise a cutter tube. The
cutter tube may comprise the tubular system and the partoff tab.
The length of the partoff tab along a tubular longitudinal axis in
the longitudinally expanded configuration may be longer than the
length of the partoff tab in the longitudinally contracted
configuration. The partoff tab can has one inflection point, when
in the contracted configuration.
[0009] A tool for acquiring tissue may comprise a cutter tube, a
partoff tube and an actuator. The partoff tab can have two flex
points, when in the contracted configuration.
[0010] A tool for acquiring tissue may comprise a cutter tube, a
partoff tube and an actuator. The partoff tab can has one
inflection point, when in the contracted configuration.
[0011] A method for operating a mass removal device is disclosed.
The mass removal device may comprise a cutter tube, comprising the
tubular system and the partoff tab. The partoff tab can have a
partoff tab first end and a partoff tab second end. The partoff tab
first end can be secured to the tubular system. The partoff tab
second end can be secured to the tubular system. The method can
comprise actuating the partoff tab, wherein the actuating comprises
extending the partoff tab radially inwardly or outwardly relative
to the cutter tube.
[0012] A method for operating a mass removal device is disclosed.
The mass removal device may comprise a cutter tube, an actuator and
a partoff tab. The partoff tab can have a partoff tab first end and
a partoff tab second end. The partoff tab first end can be secured
to the cutter tube. The partoff tab second end can be secured to
the actuator. The method can comprise actuating the partoff tab,
wherein the actuating comprises extending the partoff tab radially
inwardly or outwardly relative to the cutter tube.
[0013] A method for operating a mass removal device is disclosed.
The mass removal device may comprise a cutter tube, an actuator and
a partoff tab. The partoff tab can have a partoff tab first end and
a partoff tab second end. The partoff tab first end can be secured
to the cutter tube. The partoff tab second end can be secured to
the actuator. The method can comprise actuating the partoff tab,
wherein the actuating comprises extending the partoff tab radially
inwardly or outwardly relative to the cutter tube. The cutter tube
may rotate relative to the tissue mass. The mass removal device may
acquire multiple samples with one single insertion into the tissue
mass. The samples may stack up sequentially within the cutter
tube.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is an isometric view of a variation of the tool.
[0015] FIG. 2a and FIG. 2b illustrate a cross-sectional view of the
tool along a tubular longitudinal axis 8. FIG. 2a illustrates the
tool with the trocar out (insertion mode) and FIG. 2b illustrates
the tool with the trocar back (sampling mode).
[0016] FIG. 3 is a cross-sectional view of the distal section of
the cutter tube with a tissue-engaging inner element.
[0017] FIG. 4 is an illustrative isometric view of a variation of
the tool
[0018] FIG. 5 is a top view of a variation of the tool.
[0019] FIG. 6 is an illustrative isometric view of a variation of
the reusable handle.
[0020] FIG. 7 is an illustrative isometric view of a trocar
recessed with a trocar tube.
[0021] FIG. 8 is an illustrative isometric view of an inner tube
extending distally past the cutter tube terminal distal end.
[0022] FIG. 9 is an illustrative isometric view of a handle with a
slideable button.
DETAILED DESCRIPTION
[0023] FIG. 1 illustrates a tool 5 that can be sterilized. The tool
5 may have an ergonomic handle 6. The handle 6 can have a handle
top portion joined together with a handle bottom portion. The tool
5 may have a handle left portion and a handle right portion. The
handle top portion and the handle bottom portion may be injection
molded. The handle 6 may contain a cutter tube 10. The cutter tube
10 can be rotatable about a tubular longitudinal axis 8 or
rotationally-fixed with respect to the handle 6. The cutter tube 10
can be longitudinally fixed with respect to the handle 6. The
cutter tube 10 can extend distally from the handle 6 and can have a
cutter tube terminal distal end 12. The handle 6 can have an
electrical connection which can connect to an external power
supply. The tool 5 could instead, or in combination with an
external power supply, be powered with internal batteries,
mechanically, hydraulically or pneumatically. A cover may enclose
the samples in a collection chamber. The cover may be removed or
adjusted to provide physical access to the samples stored in the
collection chamber. The cover can be transparent, translucent, or
opaque. The rotation of the cutter tube 10 may be controlled by
actuating a first button 22. A second button 7 may actuate a
partoff mechanism 31. The second button 7 and the first button 22
may be the same button; for example, a button could have multiple
positions and depending on the position may actuate the partoff
mechanism 31 and/or rotate the cutter tube 10. The first button 22
and/or the second button 7 could be used to rotate the cutter tube
10 in different directions (e.g., clockwise and counter-clockwise).
The first button 22 and/or the second button 7 could be used to
control the position of a trocar 11. The trocar 11 could have a
sharp point; for example, the trocar 11 could be formed by three
facets; the three facets could form a trocar point 13 at the distal
terminal end of the trocar 11. The trocar point 13 could be soft
and/or atraumatic. The trocar point 13 could be rounded, chamfered,
square and/or beveled. The trocar 11 could be rigid and/or
flexible. The trocar 11 could be made from one solid piece of
material (e.g., stainless steel or plastic). The trocar 11 could be
made from two or more components; for example a portion of the
trocar 11 could have different properties than the remainder. For
example, one section of the trocar 11 could be rigid and another
section could be flexible. For example, the distal end of the
trocar 11 could feature a sharp trocar point and be made from a
rigid material such as stainless steel; for example, the proximal
end of the trocar 11 could be made from a flexible material. For
example, a flexible portion of the trocar 11 could be made from a
soft polymer. The flexible portion of the trocar 11 could be made
from a flexible assembly of rigid components, such as a chain
and/or ball chain. One section of the trocar 11 could rotate with
respect to another section of the trocar 11. For example, the
distal end of the trocar 11 could rotate with cutter tube 10, while
another section of the trocar 11 could be rotationally stationary
with respect to the handle 6. The trocar 11 could be positioned
concentrically inside of the cutter tube 10. The gap between the
outside diameter of the trocar 11 and the inside diameter of the
cutter tube 10 could be a clearance fit, such as between 0.001 to
0.006 in (0.02 to 0.15 mm). The trocar point 13 could extend past
the cutter tube terminal distal end 12 to enable easier insertion
into a tissue. A coaxial introducer 54 may be secured to the handle
6. The coaxial introducer 54 may be comprised of a tube and a luer
fitting. The luer fitting of the coaxial introducer 54 may secure
the coaxial introducer 54 to the handle 6. The coaxial introducer
54 may be secured to the handle 6 using a latch mechanism and/or
magnet. The coaxial introducer 54 may be secured to the handle 6
without rotating the coaxial introducer 54 with respect to the
handle 6. The tube of the coaxial introducer 54 may have a
clearance fit with the cutter tube 10. For example, the gap between
the cutter tube 10 and the coaxial introducer 54 may be between
0.001 to 0.006 in (0.02 to 0.15 mm). The trocar 11, the cutter tube
10 and/or the coaxial introducer 54 could use radiofrequency (RF)
energy to assist in cutting. For example, the first button 22, the
second button 7 and/or a third button could be used to control the
RF energy. RF energy could be turned on to assist during insertion
of the probe into the tissue and/or during sampling/partoff of a
tissue sample. The trocar 11 could spin relative to the handle 6
about the tubular longitudinal axis 8. The trocar 11 could be
rotationally fixed relative to the handle 6. The cutter tube 10
and/or the coaxial introducer 54 could have a lubricious coating.
For example, the outside diameter of the cutter tube 10 and/or the
coaxial introducer 54 could be coated to adjust friction with
Teflon, parylene, a hyrodophilic coating, and/or a hydrophobic
coating, The outside diameter of the cutter tube 10 and/or the
coaxial introducer 54 could be engineered to adjust friction, such
as being polished, having microscaffolds, and/or plasma activation.
outside diameter of the cutter tube 10 and/or the coaxial
introducer 54 could be modified to reduce the friction to less than
about 0.1, or more narrowly, less than about 0.05. The coaxial
introducer 54 could be longitudinally fixed and/or rotationally
fixed to the handle 6. The coaxial introducer 54 could translate
and/or rotate with respect to the handle 6. Depressing a button,
such as the first button 22 and/or the second button 7, could move
the coaxial introducer 54 and/or the cutter tube 10. For example,
when coring tissue, the coaxial introducer 54 could retract
relative to the cutter tube 10 (or the cutter tube 10 could advance
relative to the coaxial introducer 54), thereby exposing the cutter
tube terminal distal end 12. After coring, the cutter tube terminal
distal end 12 could be recessed underneath a distal end of the
coaxial introducer 54. For example, during tissue partoff and/or
tissue transport, the cutter tube terminal distal end 12 could be
recessed to allow the cutter tube 10 to spin without risking coring
and/or cutting additional tissue.
[0024] During insertion of the tool 5 into the tissue and/or while
obtaining a tissue sample, the cutter tube 10, the coaxial
introducer 54 and/or the trocar 11 could spin about the tubular
longitudinal axis 8. Spinning the cutter tube 10, the coaxial
introducer 54 and/or the trocar 11 could result in a lower and/or
more consistent resistance to advancing the tool. For example, even
if the resistance is not lower, it may be made more consistent by
minimizing the stick-slip friction phenomenon. The rotational
velocity of the spinning the cutter tube 10, the coaxial introducer
54 and/or the trocar 11 could be variable; for example, the
velocity could be dependent on the tissue type, the rate of
advancement of the tool, the state of the tool (e.g., insertion,
coring and/or partoff), and/or the temperature. The rotational
velocities of the spinning the cutter tube 10, the coaxial
introducer 54 and/or the trocar 11 could all be different and/or
the same as each other. The rotational velocities of the spinning
the cutter tube 10, the coaxial introducer 54 and/or the trocar 11
could be controlled with separate motors. The rotational velocities
of the spinning the cutter tube 10, the coaxial introducer 54
and/or the trocar 11 could be linked together, for example, with
gears and/or pulleys. The rotational velocities of the spinning the
cutter tube 10, the coaxial introducer 54 and/or the trocar 11
could be passively linked together, for example friction between
the cutter tube 10 and the coaxial introducer 54 could urge the
coaxial introducer 54 to spin with the cutter tube 10.
[0025] The cutter tube 10, the coaxial introducer 54 and/or the
trocar 11 could have a helical feature on their surface. For
example, the coaxial introducer 54 could comprise a rifled surface
14. The rifled surface 14 could be embossed and/or debossed on the
surface the coaxial introducer 54. The rifled surface 14 could be
on the inside and/or the outside of the coaxial introducer 54. The
rifled surface 14 could be clockwise and/or counter-clockwise. The
rifled surface 14 could urge the tool 5 distally or proximally as
the coaxial introducer 54 is rotated. For example, rotating the
coaxial introducer 54 during insertion and/or coring could allow
the rifled surface 14 to interact with the tissue and thereby urge
the tool distally. Urging, pulling, pushing and/or forcing the tool
longitudinally (e.g., distally and/or proximally) could provide the
operator with more control while positioning the tool 5, similar to
how power-steering provides a vehicle driver with superior
handling. The rifled surface 14 could be formed on the surface of
the coaxial introducer 54, for example by stamping and/or machining
the surface, and/or be a separate material secured to the coaxial
introducer 54 (for example by welding, soldering, brazing and/or
friction) The rifled surface 14 could be present on the cutter tube
10, the coaxial introducer 54 and/or the trocar 11.
[0026] The cutter tube 10, the coaxial introducer 54 and/or the
trocar 11 could pulse distally/proximally in the direction of
tubular longitudinal axis 8. For example, during insertion,
sampling and/or partoff the cutter tube 10, the coaxial introducer
54 and/or the trocar 11 could oscillate to reduce resistance and/or
provide superior cutting. The cutter tube 10, the coaxial
introducer 54 and/or the trocar 11 could oscillate at an ultrasonic
frequency.
[0027] A trocar tab 19 may indicate the longitudinal position of
the trocar 11 with respect to the cutter tube 10 and/or the handle
6. The trocar tab 19 may be visible in a trocar tab slot 20. The
trocar tab slot 20 may be located in the handle 6. The trocar tab
slot 20 may be open and/or covered. For example, the trocar tab
slot 20 may be a transparent section in the handle 6. The trocar
tab slot 20 may have visual and/or tactile position indicators. The
indicators on the trocar tab slot 20 may have visual and/or tactile
position indicators may be metric and/or English units, for example
every 1 cm. The indicators on the trocar tab slot 20 may have
visual and/or tactile position indicators may mark approximate
sample length. The trocar tab 19 may be adjusted by the operator to
control the position of the trocar 11. The trocar tab 19 may be
longitudinally and/or rotationally fixed with respect to the trocar
11. The trocar 11 may be secured to the trocar tab 19 and/or they
may be separate elements. The length of the trocar 11 extending
proximally out of the cutter tube 10 may be an indicator length,
such as a first indicator length, that may correspond to the length
and/or volume of the tissue in the cutter tube 10.
[0028] FIG. 2a illustrates that the cutter tube 10 may have a round
cross-section. The cutter tube 10 may be manufactured from
stainless steel hypodermic tubing (i.e., hypotube). For example,
the cutter tube 10 may be manufactured from full hard 304SS
hypotube. The hypotube may be welded and drawn. The hypotube may be
ground (e.g., centerless ground and/or plugged and ground).
[0029] FIG. 2a illustrates that the trocar 11 may be secured to a
trocar support 16. The trocar support 16 may be the trocar tab 19.
The trocar support 16 may have different properties than the trocar
11. The trocar 11 and/or the trocar support 16 may be made from
hardened 300 or 400 series stainless steel, plastic (e.g., plastic,
such as abs, delrin, glass-filled abs, glass filled delrin, ryton,
polycarbonate). The trocar support 16 may be secured to the trocar
11 via friction, welding, brazing, soldering, overmolding,
snap-fit, adhesive and/or solvent bonding. The trocar support 16
may be made injection molded. The trocar support 16 may be
flexible. The outside diameter of the trocar support 16 may be
threaded. For example, the position of the trocar support 16 may be
controlled by spinning the trocar support 16 with respect to a
threaded nut 17. The threaded nut 17 may be secured to the cutter
tube 10, the coaxial introducer 54 and/or the trocar 11. For
example, rotating the cutter tube 10 clockwise may urge the trocar
support 16 and the trocar 11 proximally. For example, rotating the
cutter tube 10 counter-clockwise may urge the trocar support 16 and
the trocar 11 distally. A portion of the trocar support 16 could be
threaded. For example, the distal end of the trocar support 16
could be unthreaded so that when the trocar support 16 is fully
proximal, the threads on the trocar support 16 do not engage with
the threaded nut 17. The threaded nut 17 could be expandable. The
threaded nut 17 could be a split and/or a partial nut. The threaded
nut 17 could be moved to control if it is engaged with the trocar
support 16.
[0030] FIG. 2b illustrates that the trocar 11 may be positioned
proximally to the cutter tube terminal distal end 12, thereby
creating a tissue sample space 18. The trocar point 13 may extend
past the cutter tube terminal distal end 12, such as a first trocar
position. The trocar point 13 may be constrained to never extend
past the cutter tube terminal distal end 12 and/or the partoff
mechanism 31. The tissue sample space 18 may be filled with zero,
one or multiple tissue samples. The tissue samples space 18 may be
bounded by the trocar 11 on the proximal end. The tissue sample
space 18 may be surrounded by the cutter tube 10. The distal end of
the tissue sample space 18 may be open or closed; for example, by
the partoff mechanism 31. The volume of the tissue sample space 18
may be adjusted. During insertion, the tissue sample space 18 may
he non-existent, if the trocar 11 extends distally past the cutter
tube terminal distal end 12. During coring, the tissue sample space
18 may be empty, partially filled with tissue and/or completely
filled with tissue. For example, the trocar 11 could be urged
and/or pushed back by tissue and/or tissue samples, thereby the
tissue sample space 18 may expand as necessary to accommodate more
tissue samples. The trocar tab 19 and/or the trocar 11 may provide
a visual and/or tactile representation of how many tissue samples
are located in the cutter tube 10. The trocar tab 19 could disable
the first button 22 and/or the second button 7 when it has reached
a certain position. When the trocar 11 is fully proximal, the
trocar tab 19 could be fully proximal. When the trocar 11 is fully
proximal, such as a second trocar position, a portion of the trocar
11 could remain within the cutter tube 10 and/or the trocar 11
could fully exit from the cutter tube 10. For example, when the
trocar 11 is fully proximal the tissue samples may exit from the
proximal end of the cutter tube 10 into the handle and/or a
collection chamber. The trocar 11 could be removed from the cutter
tube 10 and/or the handle 6 to allow the operator to access the
lumen of the cutter tube 10, for example to use a tissue transport
mechanism and/or aspiration and/or a marker. A proximal terminal
end of the trocar 11 may always be distal to a proximal terminal
end of the handle 6. The trocar 11 and/or the trocar tab 19 could
engage or disable the first button 22 and/or the second button 7
based on the position of the trocar 11 and/or the trocar tab 19
with respect to the handle 6 and/or the cutter tube 10. The trocar
11 could be positioned fully proximally during coring, thereby
expanding the tissue sample space 18 to the maximum possible
volume; the tissue samples could fill the tissue sample space 18 as
necessary. The proximal end of the tissue sample space 18 could be
open. For example, the trocar 11 could fully exit the cutter tube
10; thereby, allowing the operator to obtain more tissue samples
than could fit inside of the cutter tube 10 at one time. The trocar
11 could be advanced distally to push out any samples from the
tissue sample space 18. For example, the tool 5 could be removed
from the tissue and the tissue samples could exit from cutter tube
terminal distal end 12. After the trocar 11 has pushed out tissue
samples from the tissue sample space 18, the trocar 11 could be
positioned distal to the cutter tube terminal distal end 12 (as
shown in FIG. 2a) and the tool 5 could be in the insertion state;
the operator could then insert the tool into the tissue and obtain
additional tissue samples.
[0031] FIG. 2b illustrates that the tool 5 can be manually advanced
into the tissue. The operator may press the first button 22 and/or
the second button 7 to place the tool 5 in a coring state. In the
coring state, the cutter tube 10 may be spinning. The cutter tube
terminal distal end 12 may cut through the tissue as the cutter
tube 10 is advanced. The terminal distal end 12 may be sharpened. A
tissue sample or tissue samples may enter into the tissue sample
space 18. The operator may manually advance the tool 5 through the
tissue while the cutter tube 10 is spinning. The operator may
control the rate of advancement and total deflection of the cutter
tube 10 and/or the tool 5. For example, the the operator may be
able to obtain different tissue sample lengths. For example, the
operator may advance the tool slowly for safety reasons and/or
depending on the tissue type (e.g., hard and/or dense tissues).
[0032] FIG. 3 illustrates that a partoff tab 30 may obstruct tissue
samples 101d and 101e from exiting the cutter tube 10. The partoff
tab 30 may be a component in the partoff mechanism 31. The partoff
mechanism 31 may be used to sever a tissue sample from a tissue
site; for example after the tissue sample has been cored (but may
still be attached to the tissue site). The partoff mechanism 31 may
be a passive and/or active system. For example, the partoff
mechanism 31 may be deployable tab, a multi-bar linkage or a
passive, spring-loaded tab. The partoff mechanism 31 may be
deployed while the spinning about the tubular longitudinal axis 8.
The partoff mechanism 31 may be at least one tab that may allow the
tissue to move proximally and/or distally along the tubular
longitudinal axis 8. The coaxial introducer 54 may control the
deployment of the partoff mechanism 31; for example, the axial
position of the coaxial introducer 54 and/or the tissue-engaging
inner element 100 relative to the cutter tube 10 may control the
position of the partoff mechanism 31. A tissue-engaging inner
element 100 may be located inside of the cutter tube 10. For
example, the tissue-engaging inner element 100 may be helically
shaped. The tissue-engaging inner element 100 may be made from
stainless steel. The tissue-engaging inner element 100 may be
rotationally stationary/fixed or spin with respect to the cutter
tube 10. The tissue-engaging inner element 100 may be rotationally
stationary and/or rotate with respect to the handle 5. The
tissue-engaging inner element 100 may be longitudinally fixed
and/or move relative to the handle 5 and/or the cutter tube 10. The
tissue samples 101d and 101e may contact the tissue-engaging inner
element 100 and/or the cutter tube 10. For example, the cutter tube
10 may urge tissue samples 101d and 101e to spin. For example, the
tissue samples 101d and 101e may spin relative to the
tissue-engaging inner element 100. The relative rotation between
the tissue samples 101d and/or 101e and the tissue-engaging inner
element 100 may urge the tissue samples proximally and/or distally
relative to the handle 5. For example, while advancing the tool 5
into the tissue, the cutter tube 10 may be spinning (e.g., spinning
relative to the handle 5 and/or the tissue) and may be coring
tissue samples 101d and/or 101e and may be positioning them inside
of the tissue sample space 18. The relative rotation between the
tissue sample(s) 101d and/or 101e and the tissue-engaging inner
element 100 may urge/pull/force the tissue further into the cutter
tube 10; for example, creating a mechanical suction force to obtain
larger tissue sample(s)/Old and/or 101e. Transporting the tissue
samples 101d and/or 101e proximally inside of the cutter tube 10
may create a vacuum, thereby drawing more tissue into the cutter
tube 10. A vacuum may be applied while sampling and/or advancing
the tool to urge tissue into the cutter tube 10. For example, the
handle 6 and/or the cutter tube 10 may be longitudinally stationary
while a vacuum is applied to the proximal end of the cutter tube
10. The vacuum may urge tissue into the cutter tube 10, which may
be cored and/or cut while the cutter tube 10 is spinning.
[0033] FIG. 3 illustrates that the tissue sample 101d may be
acquired first (e.g., coring into the tissue mass and then parting
off the tissue sample from the tissue mass). The subsequent tissue
sample 101e may be acquired from the same tissue mass or a
different tissue mass. As the tissue sample 101e is cored, it may
push the first tissue sample 101d proximally towards the handle.
The samples may be stored sequentially/chronologically in the order
they were acquired. The samples may be removed by pushing them out
with a rod. The samples may be removed by hydraulic, pneumatic
pressure and/or vacuum. The partoff tab 30 may be left in the
actuated position to prevent the tissue samples 101 from exiting
from the distal end 12.
[0034] FIG. 3 illustrates that the tissue-engaging inner element
100 may be located within the cutter tube 10. The tissue transport
system 100 may comprise an elongated coil. The tissue-engaging
inner element 100 may be rotationally stationary relative to the
handle 6. The tissue-engaging inner element 100 may terminate
proximal to the partoff tab 30. The tissue-engaging inner element
100 may terminate approximately 2-3 cm proximal to the partoff tab
30. The tissue-engaging inner element 100 may engage with tissue
sample 101d after a second tissue sample 101e pushes the tissue
sample 101d into contact with the tissue-engaging inner element
100. For example, the operator may first acquire a tissue sample
101d. The operator may then acquire the second tissue sample 101e,
which subsequently pushes the tissue sample 101d proximally and
into contact with the tissue-engaging inner element 100. Once the
tissue sample 101d is engaged with the tissue-engaging inner
element 100, the tissue sample 101d may be transported proximally
into the handle 6. For example, if the tissue sample 101d is
rotating relative to the tissue-engaging inner element 100, it may
be urged proximally (e.g., a corkscrew effect). The tissue-engaging
inner element 100 may extend fully to the partoff tab 30 such that
the tissue sample 101d is immediately in contact with the
tissue-engaging inner element 100 without requiring the second
tissue sample 101e to push the tissue sample 101d proximally. The
tissue-engaging inner element 100 may translate relative to the
cutter tube 10; for example, the transport system 100 may oscillate
proximally/distally by 0.5 to 1 mm.
[0035] FIG. 4 and FIG. 5 illustrate that the handle 6 could feature
a reusable handle 50. The reusable handle 50 and/or the handle 6
could include at least one of a motor, switch, power jack, battery,
LED, PCB, resistor, circuit, capacitor, nitinol actuator, shape
memory actuator, muscle wire, spring and/or string. The trocar 11
and/or the trocar tab 19 could be visible in the handle 6. The
trocar 11 and/or the trocar tab 19 could be controlled using the
first button 22 or another button (not shown). The trocar 11 could
be pushed proximally by a tissue sample 101. The trocar 11 could be
pushed and/or pulled manually, automatically or semi-automatically.
For example, the operator could push the trocar 11 and/or the
trocar tab 19 distally. The operator could turn a wheel and/or a
thumb wheel which could engage the trocar 11 and/or the trocar tab
19; for example, the thumb wheel could contact the trocar 11 and/or
the trocar tab 19 with friction or a rack/pinion mechanism. The
thumb wheel could be geared to ensure optimize the level of torque
and/or manipulation required. The tissue indicator could be
straight, the trocar tab slot 20 is shown or it could be a
different shape and/or mechanism. For example, the trocar tab slot
20 could be round and/or spiral. The tissue indicator could be a
dial indicator that could be driven by the trocar 11 and/or the
trocar tab 19. For example, a string or wire could be connected
between the trocar tab 19 and/or the proximal end of the trocar 11
and/or an indicator (e.g., a dial indicator and/or the trocar tab
slot 20). A string or wire could be connected between the trocar
tab 19 and/or the trocar 11 and a rotary and/or linear actuator.
For example, a string or wire could be connected to both a pulley
and the trocar tab 19 and/or the trocar 11; rotating the pulley
could pull on the string and therefore force the trocar point 13
distally; the pulley could be driven manually and/or using an
actuator, such as a motor. A second motor (in addition to the motor
used to spin the cutter tube 10) could be used to actuate the
trocar tab 19 and/or the trocar 11. Forcing the trocar 11 distally
could push tissue samples out of the cutter tube terminal distal
end 12. The trocar 11 and/or the trocar tab 19 could be manipulated
using various actuators, including a brushed motor, a brushless
motor, a spring, and/or a shape memory actuator. The handle 6 could
contain two buttons: one button could be used for coring the tissue
and the other button could be used for advancing the position of
the trocar 11. During coring, the trocar 11 could be pushed back by
tissue samples or using an actuator built into the tool 5. The
trocar 11 and/or the trocar point 13 can spin with the cutter tube
10 to minimize trauma to any tissue samples.
[0036] FIG. 6 illustrates that the reusable handle 50 could be
battery and/or wall-powered (e.g., tethered). The reusable handle
could be sealed from the patient and patient tissue/fluids to
prevent cross-contamination. For example, seals and/or magnets
(e.g., non-contact actuation) can be used to prevent the reusable
handle from engaging with patient tissue directly or indirectly.
The reusable handle may contain a first hub 51 and a second hub 52.
The first hub 51 and/or the second hub 52 may engage with
interlocking hubs on the disposable handle. The first hub 51 and/or
the second hub 52 may be driven using the same actuator or
different actuators. The first hub 51 and/or the second hub 52 may
use one-way clutches so that the first hub 51 and/or the second hub
52 may be driven in only one direction. For example, spinning a
motor clockwise may drive only the first hub 51 while driving the
motor counter-clockwise may drive only the second hub 52 (or
vice-versa). Alternatively, one hub may always be driven, whereas
the other hub may be only driven in one direction. A speed reducer
and/or gear head may be used to adjust the speed and/or torque of
one hub versus the other hub.
[0037] The coaxial introducer 54 and/or the cutter tube 10 may be
longitudinally fixed with respect to the handle 6. The coaxial
introducer 54 and/or the cutter tube 10 may be partially
longitudinally fixed with respect to the handle 6. For example,
during tissue coring, the coaxial introducer 54 and/or the cutter
tube 10 may be advanced or retracted between 0.01 in (0.25 mm) and
1 in (2.5 cm), for example 0.06 in (1.5 mm) and remain
longitudinally fixed with respect to the handle 6 while the tool is
manually advanced into the tissue. Upon completion of coring, the
coaxial introducer 54 and/or the cutter tube 10 may be retracted or
advanced. The cutter tube 10 may continue to spin after the first
button 22 and/or another button is released; for example the cutter
tube 10 may continue to spin 0.01 to 30 seconds, such as
approximately 0.5 or 1 second. Depressing the first button 22 may
adjust the partoff mechanism 31 to the coring state and then spin
the cutter tube 10. Releasing the cutter tube 10 may adjust the
partoff mechanism 31 into the partoff state, keep the cutter tube
spinning for a pre-determined or user-dependent time period such as
0.5 seconds to complete tissue partoff/severing/cutting and then
stop the cutter tube 10 from spinning. Manipulating the axial
position of the coaxial introducer 54 and the cutter tube 10 with
respect to each other may allow the cutter tube 10 to continue
spinning while preventing the cutter tube terminal distal end 12
from coring additional tissue. For example, after coring a tissue
sample, the cutter tube 10 may continue to spin to partoff the
tissue sample from the tissue mass and/or transport the tissue
sample (e.g., using a helical transport element); adjusting the
linear position of the cutter tube 10 with respect to the coaxial
introducer 54 may hide the cutter tube terminal distal end 12
within the coaxial introducer 54 to ensure that no additional
tissue is cored and/or traumatized. The coaxial introducer 54 may
be rotationally fixed with respect to the handle 6 and/or the
tissue. The coaxial introducer 54 may rotate with or with respect
to the cutter tube 10.
[0038] FIG. 7 illustrates that a trocar tube 120 may be positioned
concentrically over the trocar 11. The trocar tube 120 may be a
clearance fit with the trocar 11, for example with a gap of less
than 0.01 in, approximately, 0.005 inches. The trocar 11 may be
longitudinally moveable and/or fixed with respect to the trocar
tube 120. The trocar 11 may be rotationally moveable and/or fixed
with respect to the trocar tube 120. During insertion of the tool 5
into the tissue, the trocar point 13 may extend distal to a trocar
tube distal end 121. During tissue acquisition, the trocar point 13
may be recessed proximally to the trocar tube distal end 121;
thereby protecting the trocar point 13 and minimizing trauma to the
tissue samples that could be created by the trocar point 13. A
flexible and/or a slit seal could be placed on the distal end of
the trocar tube to minimize contact between the trocar point 13 and
tissue samples. The trocar tube distal end 121 could be in contact
with the tissue samples 101 during tissue acquisition and when
pushing the tissue samples 101 out of the cutter tube 10.
[0039] FIG. 8 illustrates that an inner tube 125 may be located
concentrically within the cutter tube 10. The inner tube 125 may
have a dull or a sharp end. The inner tube 125 may be rotationally
and/or longitudinally fixed with respect to the cutter tube 10. The
inner tube 125 may rotate or move with respect to the cutter tube
10. The inner tube 125 may have a clearance fit with the cutter
tube 10, with a gap of less than 0.02 inches between the walls, for
example 0.003 inches. The inner tube 125 may be proximal to the
cutter tube terminal distal end 12 during coring and distal to the
coring tube distal end 12 when the tool 5 is not coring. The tool 5
can be used with different imaging systems, including ultrasound,
stereotactic, MRI, x-ray tomography and/or tomosynthesis. The tool
5 can be advanced manually, automatically or semi-automatically.
The tool 5 can be used to capture tissue samples of variable
lengths. When used manually (e.g., under ultrasound guidance), the
operator may visualize the tool 5 cutting through the tissue and
obtain the ideal length of tissue required. When used manually
(e.g., under ultrasound guidance), the operator may visualize the
tool 5 cutting through the tissue and ensure that the tool 5 does
not cause unnecessary patient trauma; for example, if the operator
realizes that the tool 5 is about to enter an undesired tissue, the
operator can release a button on the tool 5 and/or stop advancing
the tool 5. The first button 22 can be depressed and/or moved
axially, thereby allowing additional functionality with a single
button. For example, depressing the first button 22 may control the
rotation of the cutter tube 10 and pushing the first button 22
forward and/or backward may control the partoff mechanism 31.
Manipulating the first button 22 to the left and/or right may
control the position of the trocar 11. Depressing the first button
22 may control the rotation of the cutter tube 10 and pulling the
first button 22 backward may control the partoff mechanism 31 and
pushing the first button 22 forward may control the position of the
trocar 11. A knob and/or button may be used to control the position
of the cutter tube 10 with respect to the handle 6. For example,
spinning a knob may advance the cutter tube 10 distally while
holding the handle 6 stationary, thereby offering precise control
of the cutter tube terminal distal end 12 without having to
manipulate the handle 6 with respect to the tissue. Depressing the
first button 22 may cause the cutter tube 10 to be advanced
distally at a pre-determined rate (such as 0-2 cm per second,
approximately 1 cm/sec) and/or distance (such as 1, 2 or 3 cm) and
releasing the first button 22 may cause the cutter tube 10 to
retract into the handle 6. In the default, standby position the
cutter tube terminal distal end 12 may be proximal to a distal end
of the coaxial introducer 54 or the inner tube 125, thereby
sheathing the sharp end of the cutter tube terminal distal end 12.
During coring and as the cutter tube 10 is spinning, the cutter
tube terminal distal end 12 may be positioned distal to a distal
end of the coaxial introducer 54 or the inner tube 125, thereby
allowing the cutter tube terminal distal end 12 to be in contact
with the tissue. Sheathing and unsheathing the cutter tube terminal
distal end 12 may protect both the cutter tube terminal distal end
12 and the patient from unnecessary and/or unintended trauma. A
light, such as and LED or electroluminescent material may be used
in the tool 5. The light may be used to illuminate the tissue, the
buttons, the trocar 11 and/or the trocar tab 19. A digital
indicator may be used to indicate the position of the trocar point
13. The distance and/or angular position between the trocar point
13 and the trocar tab 19 may be fixed or variable. For example, the
trocar point 13 and the trocar tab 19 could be made from the same
material (e.g., an injection molded component). The trocar tab 19
could be a separate component that can be used to push the trocar
point 13 distally but not be able to apply proximal force to the
trocar point 13. The proximal end of the trocar 11 may be used to
indicate the position of the trocar point 13 instead of the trocar
tab 19.
[0040] FIG. 9 illustrates that the second button 7 could be
slideable within a button track 201. The button track 201 could
extend for the entire length of the handle 6 or a portion of the
handle 6. The second button 7 can slide within the button track
201, for example between a first button track position 202a and a
second button track position 202b. The second button 7 may engage
directly and/or indirectly with the trocar 11. For example, the
button 7 could feature a one-way clutch mechanism. Many versions of
one-way clutch mechanisms exist, including those found in ratchets,
clamps, speed clamps and one-way bearings. An example of a one-way
clutch mechanism could be a piece of sheet metal, for example
between 0.005 in (0.13 mm) to 0.060 in (1.5 mm) thick, such as
.about.0.02 in thick (0.5 mm) with a hole and/or slot cut into the
strip that the trocar 11 may slide through; the angle of the sheet
metal strip may be such that the sheet metal may bind with the
trocar 11 in one direction but be unbound in a second direction.
For example, the sheet metal strip may be at an angle of 5-60
degrees with respect to a front plane, such as 15 and/or 20
degrees. The front plane may be perpendicular to the tubular
longitudinal axis 8. Another one-way clutch mechanism may include
two ball bearings on opposite sides of the trocar 11 that are
housed within a ramped slot(s), such that the ball bearings squeeze
against the trocar 11 and bind the trocar 11 when it slides in one
direction, but disengage when the trocar 11 moves in the other
direction. Sliding the second button 7 between the first button
track position 202a and the second button track position 202b may
push the trocar 11 distally. The second button 7 may be slid
repeatedly between button track positions 202a and 202b to move the
trocar 11 distally until it exits the cutter tube terminal distal
end 12. A third button track position 202c may allow the second
button 7 to engage with an unlocking post 200. The unlocking post
200 may disable the one-way clutch in the second button 7, thereby
allowing the trocar 11 to slide freely proximally, distally and/or
rotationally. For example, when coring and/or obtaining tissue, the
second button 7 may be in the third button track position 202c,
thereby engaging with the unlocking post 200 and allowing tissue
samples 101 to push proximally on the trocar 11 and therefore
translate the trocar 11 proximally. The trocar 11 may be visible
through the button track 201 and/or the handle 6, thereby providing
an indication of how much tissue is located within the cutter tube
10. The operator may then remove the device from the tissue site
and remove the tissue samples 101 from the cutter tube 10 by
sliding the second button 7 back and forth between button track
positions 202a and 202b. A button locking feature may be present to
limit the motion of the second button 7 between the button track
positions 202a and 202b; the button locking feature may be
disengaged by depressing the first button 22. The button locking
feature may be used to ensure that the second button 7 does not
contact the unlocking post 200. During insertion of the tool 5 into
the tissue site, the button locking feature may be used to ensure
that the second button 7 is binding the trocar 11 such that it does
not slip proximally into the cutter tube 10. The button locking
feature may lock the second button 7 and/or the trocar 11, such as
the terminal proximal end of the trocar 11. The button locking
feature may use the trocar 11 as a guide, such that the button
locking feature locks the second button 7 and/or the trocar 11 once
the trocar 11 has reached a certain position, such as when the
trocar point 13 is extending past the cutter tube terminal distal
end 12. The second button 7 may include a button ramp 205 which may
engage directly and/or indirectly with the first button 22 and/or
the partoff mechanism 31. For example, when advancing the trocar 11
distally, the button ramp 205 may force the first button 22 into a
position where the partoff mechanism 31 is hidden and/or retracted
(e.g., in the coring state and/or configuration), thereby allowing
tissue samples 101 to exit from the cutter tube 10. For example,
the button ramp 205 could prevent the first button 22 from being
fully depressed and therefore spinning the cutter tube 10. The
trocar 11 could be removed entirely from the handle 6. One or more
springs may be used, for example to bias the second button 7
proximally. If the trocar 11 is removed from the handle 6 or is
moved proximally such that it does not engage with the cutter tube
10, tissue samples 101 may enter a sample collection space 210. The
sample collection space 210 may be a collection chamber. The
proximal end of the trocar 11 may have a larger diameter and/or a
lip. For example, the proximal 0.02 in (0.5 mm)-0.8 in (2 mm) of
the trocar 11, such as Olin (2.5 mm) in length may have a larger
major diameter than the remainder of the trocar. The proximal lip
of the trocar 11 may be formed by deforming the trocar 11, for
example by clamping, crimping and/or swaging. The proximal lip of
the trocar 11 may be formed by securing another component to the
trocar 11 such as a thin-walled tube, which could be glued,
crimped, press-fit, brazed, welded, soldered or mechanically
fastened to the trocar 11. The proximal lip of the trocar 11 may
engage with the cutter tube 10, the handle 6 and/or the second
button 7 to prevent the trocar 11 from advancing to far distally.
The proximal lip of the trocar 11 may allow the trocar 11 to spin
freely with respect to the handle 6. The trocar 11 could be
transported using a cable, thread, wire, electromechanically,
electromagnetically, magnetically, pneumatically, hydraulically,
with a vacuum, with a spring and/or manually (e.g., by manually
pushing and/or pulling on the trocar). The sheet metal strip may be
formed by stamping, laser-cutting, metal injection molding,
water-jet cutting, machining, plasma cutting, etching and/or
cutting. The button track 201 may be the trocar tab slot 20.
[0041] The tissue samples can be transported using a helical
transport system (e.g., a stationary coil) and/or with additional
systems. For example, a second tube can be located concentrically
within the cutter tube 10 and be pulled proximally. The second tube
can have adjustable and/or one-way locking features to engage or
secure the tissue samples 101. The second tube may be the same as
the inner tube 125. One-way locking features may include tabs that
are bent inwards and allow the tissue samples 101 to move
proximally, but not distally. The coil may be moved proximally with
or without tissue samples 101. A vacuum may be used to pull tissue
samples 101 proximally. The trocar 11 may be flexible. The trocar
11 may wrap around a pulley, which may be turned to advance and/or
retract the trocar 11; the angular position of the pulley may be
used to indicate the position of the trocar point 13. The trocar 11
may be flexible and be located within a contoured guide within the
handle 6 or an empty space within the handle 6. The trocar 11 may
extend past the handle 6, for example proximal to the handle 6
and/or trocar tab slot 20. A compression, tension, torsion, clock
and/or power spring may be used to bias the trocar 11 in a distal
and/or proximal direction. A ratchet mechanism may be used to
advance or retract the trocar 11. For example, a button and/or knob
may be pushed forward from the default position 0.1 to 3 inches,
for example 0.75 in to advance the trocar 11 and then retract to
the default position with a spring; adjusting the position of the
trocar 11 during the manual pushing step but without adjusting the
position of the trocar 11 during the retracting step.
[0042] The internal diameter of the cutter tube 10 may be larger
than about 0.04 in (1.0 mm), yet more narrowly larger than about
0.06 in (1.5 mm), yet more narrowly larger than about 0.08 in (2.0
mm), yet more narrowly larger than about Olin (2.5 mm), yet more
narrowly larger than about 0.12 in (3.0 mm), yet more narrowly
larger than about 0.14 in (3.5 mm) or yet more narrowly larger than
about 0.16 in (4.0 mm). The internal diameter of the cutter tube 10
may be less than about 0.16 in (4.0 mm), or yet more narrowly
smaller than about 0.14 in (3.5 mm), or yet more narrowly smaller
than about 0.12 in (3.0 mm), or yet more narrowly smaller than
about 0.10 in (2.5 mm), or yet more narrowly smaller than about
0.08 in (2.0 mm), or yet more narrowly smaller than about 0.06 in
(I 0.5 mm) or yet more narrowly smaller than about 0.04 in (1.0
mm).
[0043] The wall thickness of the cutter tube 10 may be larger than
about 0.002 in (0.05 mm), or yet more narrowly larger than about
0.004 in (0.10 mm) or yet more narrowly larger than about 0.006 in
(0.15 mm). The wall thickness of the cutter tube 10 may be smaller
than about 0.006 in (0.15 mm), or yet more narrowly smaller than
about 0.004 in (0.10 mm) or yet more narrowly smaller than about
0.002 in (0.05 mm). The wall thickness of the cutter tube 10 may
vary. For example, the partoff tab 30 may have a different wall
thickness than the actuator 32.
[0044] The cutter tube 10 or any or all elements of the tool and/or
other tools or apparatuses described herein can be made from or
coated with, for example, single or multiple stainless steel
alloys, steel, spring steel, nickel titanium alloys (e.g.,
Nitinol), cobalt-chrome alloys (e.g., ELGILOY.RTM. from Elgin
Specialty Metals, Elgin, Ill.; CONICHROME.RTM. from Carpenter
Metals Corp., Wyomissing, Pa.), nickel-cobalt alloys (e.g.,
MP35N.RTM. from Magellan Industrial Trading Company, Inc.,
Westport, Conn.), molybdenum alloys (e.g., molybdenum TZM alloy),
tungsten-rhenium alloys, polymers such as polyethylene
teraphathalate (PET), polyester (e.g., DACRON.RTM. from E. I. Du
Pont de Nemours and Company, Wilmington, Del.), polypropylene,
aromatic polyesters, such as liquid crystal polymers (e.g.,
Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultra high
molecular weight polyethylene (i.e., extended chain, high-modulus
or high-performance polyethylene) fiber and/or yarn (e.g.,
SPECTRA.RTM. Fiber and SPECTRA.RTM. Guard, from Honeywell
International, Inc., Morris Township, N.J., or DYNEEMA.RTM. from
Royal DSM N.V., Heerlen, the Netherlands), polytetrafluoroethylene
(PTFE), Parylene poly(p-xylylene) polymers, Parylene N, Parylene C,
Parylene D, expanded PTFE (ePTFE), polyether ketone (PEK),
polyether ether ketone (PEEK), polycarbonate (PC), Acrylonitrile
Butadiene Styrene (ABS), poly ether ketone ketone (PEKK) (also poly
aryl ether ketone ketone), nylon, polyether-block co-polyamide
polymers (e.g., PEBAX.RTM. from ATOFINA, Paris, France), aliphatic
polyether polyurethanes (e.g., TECOFLEX.RTM. from Thermedics
Polymer Products, Wilmington, Mass.), polyvinyl chloride (PVC),
Nylon, Vinyl, polyurethane, thermoplastic, fluorinated ethylene
propylene (FEP), absorbable or resorbable polymers such as
polyglycolic acid (PGA), poly-L-glycolic acid (PLGA), polylactic
acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL),
polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino
tyrosine-based acids, extruded collagen, silicone, zinc, echogenic,
radioactive, radiopaque materials, a biomaterial (e.g., cadaver
tissue, collagen, allograft, autograft, xenograft, bone cement,
morselized bone, osteogenic powder, beads of hone), a material with
high strength (60 ksi) and biocompatibility, any of the other
materials listed herein or combinations thereof. Examples of
radiopaque materials are barium sulfate, zinc oxide, titanium,
stainless steel, nickel-titanium alloys, tantalum and gold. The
device can be made from substantially 100% PEEK, braided nylon,
braid reinforce nylon, braid reinforced polyimide, braid reinforced
tubing, substantially 100% titanium or titanium alloy, or
combinations thereof.
[0045] The cutter tube 10 may spin or rotate at a velocity relative
to the handle 6 of greater than about 100 rpm, yet more narrowly
larger than about 1,000 rpm, yet more narrowly larger than about
2,500 rpm, yet more narrowly larger than about 3,000 rpm, yet more
narrowly larger than about 4,000 rpm, yet more narrowly larger than
about 5,000 rpm, yet more narrowly larger than about 7,500 rpm, yet
more narrowly larger than about 10,000 rpm. The cutter tube 10 may
spin or rotate at a velocity relative to the handle 6 of less than
about 10,000 rpm, yet more narrowly less than about 7,500 rpm, yet
more narrowly less than about 5,000 rpm, yet more narrowly less
than about 4,000 rpm, yet more narrowly less than about 3,000 rpm,
yet more narrowly less than about 2,500 rpm, yet more narrowly less
than about 1,000 rpm, yet more narrowly less than about 100
rpm.
[0046] The internal diameter of the cutter tube 10 may be larger
than about 0.5 mm (0.02 in), more narrowly larger than about 1 mm
(0.04 in), yet more narrowly larger than about 1.5 mm (0.06 in),
yet more narrowly larger than about 2 mm (0.08 in), yet more
narrowly than about 2.5 mm (0.10 in), yet more narrowly larger than
about 3 mm (0.12 in), yet more narrowly larger than about 3.5 mm
(0.14 in), yet more narrowly larger than about 4 mm (0.18 in), yet
more narrowly larger than about 4.5 mm (0.18 in), yet more narrowly
larger than about 5 mm (0.20 in), yet more narrowly larger than
about 6 mm (0.24 in), yet more narrowly larger than about 7 mm
(0.28 in), or yet more narrowly larger than about 10 mm (0.39 in).
The internal diameter of the cutter tube 10 may be less than about
10 mm (0.39 in), more narrowly less than about 7 mm (0.28 in), yet
more narrowly less than about 6 mm (0.24 in), yet more narrowly
less than about 5 mm (0.20 in), yet more narrowly less than about
4.5 mm (0.18 in), yet more narrowly less than about 4 mm (0.18 in),
yet more narrowly less than about 3.5 mm (0.14 in), yet more
narrowly less than about 3 mm (0.12 in), yet more narrowly less
than about 2.5 mm (0.10 in), yet more narrowly less than about 2 mm
(0.08 in), yet more narrowly less than about 1.5 mm (0.06 in), yet
more narrowly less than about 1 mm (0.04 in), or yet more narrowly
less than about 0.5 mm (0.02 in).
[0047] The wall thickness of the cutter tube 10 may be larger than
about 0.05 mm (0.002 in), more narrowly larger than about 0.10 mm
(0.004 in), yet more narrowly larger than about 0.15 mm (0.006 in),
yet more narrowly larger than about 0.20 mm (0.008 in), yet more
narrowly larger than about 0.30 mm (0.012 in), yet more narrowly
larger than about 0.50 mm (0.020 in), yet more narrowly larger than
about 0.70 mm (0.028 in), or yet more narrowly larger than about
1.00 mm (0.039 in). The wall thickness of the cutter tube 10 may be
less than about 1.00 mm (0.039 in), yet more narrowly less than
about 0.70 mm (0.028 in), yet more narrowly less than about 0.50 mm
(0.020 in), yet more narrowly less than about 0.43 mm (0.017 in),
yet more narrowly less than about 0.30 mm (0.012 in), yet more
narrowly less than about 0.20 mm (0.008 in), yet more narrowly less
than about 0.15 mm (0.006 in), yet more narrowly less than about
0.10 mm (0.004 in), or yet more narrowly less than about 0.05 mm
(0.002 in).
[0048] Multiple tissue samples can be collected and/or obtained
and/or parted-off without removing the tool from the mass of tissue
(i.e., tissue mass). The tubular longitudinal axis 8 can pass
through the cutter tube 10, the transport system 100 and/or the
handle 6. The cutter tube terminal distal end 12 may be sharpened
mechanically, electro-chemically and/or chemically. The trocar 11
may slide in the cutter tube 10 and/or the handle 6. The first
button 22 and/or the second button 7 may contact the trocar 11
and/or the trocar tab 19. There may be sufficient friction between
the trocar 11 and another component in the tool 5 (such as the
cutter tube 10, the first button 22, the handle 6 and/or the second
button 7) to prevent the trocar 11 from moving relative to the
handle 6 because of gravity; however, the friction may be low
enough to allow the tissue samples 101 to urge the trocar 11
proximally. The frictional force may be adjustable; for example,
the friction between the trocar 11 and another component in the
tool 5 (such as the cutter tube 10, the first button 22, the handle
6 and/or the second button 7) may be lower when the first button 22
and/or the second button 7 are depressed than when no buttons are
depressed. The frictional force between the trocar 11 and another
component in the tool 5 (such as the cutter tube 10, the first
button 22, the handle 6 and/or the second button 7) may be between
0.01 and 2 Newtons.
[0049] The trocar 11 may be slidably positioned inside of the
cutter tube 10. The handle may be longitudinally fixed with respect
to the cutter tube 10. The cutter tube 10 may be a coring element.
The trocar 11 may be an indicator. For example, the trocar 11 may
be string, a liquid and/or some other material that may be
displaced by the tissue samples 101 in the cutter tube 10.
[0050] PCT/US 2014/052,431 filed Aug. 26, 2014; U.S. application
Ser. No. 14/517,873 filed Oct. 19, 2014; PCT/US11/061,089 filed
Nov. 16, 2011; U.S. Pat. No. 8,317,727 filed on Apr. 21, 2012; U.S.
Provisional Application Nos. 61/872,678, filed Aug. 31, 2013;
62/086,523, filed on Dec. 2, 2014; 61/872,674, filed Aug. 31, 2013
are all incorporated by reference herein in their entireties.
[0051] It is apparent to one skilled in the art that various
changes and modifications can be made to this disclosure, and
equivalents employed, or combinations of any of the disclosed
elements, characteristics, features, devices, tools, steps, or
methods without departing from the spirit and scope of the
invention. Any of the disclosed elements, characteristics,
features, devices, tools, steps, or methods can be present as a
singular or as a plurality regardless of whether the elements,
characteristics, features, devices, steps, or methods are
explicitly disclosed herein as being singular or as a plurality.
Elements shown with any variation are exemplary for the specific
variation and can he used on other variation within this
disclosure.
* * * * *