U.S. patent application number 17/499091 was filed with the patent office on 2022-05-12 for soft and hard tissue excisional devices and methods.
The applicant listed for this patent is TransMed7, LLC. Invention is credited to Eugene H. VETTER, James W. VETTER.
Application Number | 20220142622 17/499091 |
Document ID | / |
Family ID | |
Filed Date | 2022-05-12 |
United States Patent
Application |
20220142622 |
Kind Code |
A1 |
VETTER; Eugene H. ; et
al. |
May 12, 2022 |
SOFT AND HARD TISSUE EXCISIONAL DEVICES AND METHODS
Abstract
A device may comprise a work element, an outer tube co-axially
disposed around a portion of the work element and a collar
assembly. The work element may be configured to rotate and define
proximal and distal ends, and may comprise a body portion, one or
more articulable beak(s) configured to cut tissue, and a beak
actuation portion. The collar assembly may be coupled to the work
element away from the articulable beak(s), and may comprise a
distal collar element coupled to the body portion, a middle collar
element coupled to the outer tube and a proximal collar element
coupled to the beak actuation portion. The distal collar element
may comprise a first peripheral surface that extends around the
distal collar element and that faces the proximal end and the
middle collar element may comprise a second peripheral surface that
that extends around the middle collar element, faces the distal end
and at least partially contacts the first peripheral surface. The
first and second peripheral surfaces each may comprise a smooth
undulating surface that comprises a plurality of peaks and valleys.
The distal, middle and proximal collar elements may be configured
to control opening, closing, extending and retracting the
articulable beak(s) by rotating in synchronicity, rotating
differentially and/or moving toward the distal or proximal
ends.
Inventors: |
VETTER; Eugene H.; (Portola
Valley, CA) ; VETTER; James W.; (Portola,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
TransMed7, LLC, |
Portola Valley |
CA |
US |
|
|
Appl. No.: |
17/499091 |
Filed: |
October 12, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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17153582 |
Jan 20, 2021 |
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17499091 |
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16000047 |
Jun 5, 2018 |
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17153582 |
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International
Class: |
A61B 10/02 20060101
A61B010/02; A61B 17/3207 20060101 A61B017/3207; A61B 10/06 20060101
A61B010/06 |
Claims
1. A device, comprising: a work element configured to rotate and
defining a proximal end and a distal end away from the proximal
end, the work element comprising a body portion, at least one
articulable beak disposed at a distal end of the body portion and
configured to cut tissue, and a beak actuation portion; an outer
tube co-axially disposed around a portion of the work element; a
collar assembly coupled to the work element away from the at least
one articulable beak, the collar assembly comprising at least a
distal collar element coupled to the body portion of the work
element, a middle collar element coupled to the outer tube and a
proximal collar element coupled to the beak actuation portion, the
distal collar element comprising a first peripheral surface that
extends around the distal collar element and that faces the
proximal end, the middle collar element comprising a second
peripheral surface that that extends around the middle collar
element, faces the distal end and at least partially contacts the
first peripheral surface; wherein the first peripheral surface is a
smooth surface that comprises a plurality of first peaks and a
plurality of first valleys and the second peripheral surface is a
smooth surface that comprises a plurality of second peaks and a
plurality of second valleys, and wherein the distal, middle and
proximal collar elements are configured to control opening,
closing, extending and retracting the at least one articulable beak
by at least one of rotating in synchronicity, rotating
differentially, moving toward the distal end and moving toward the
proximal end.
2. The device of claim 1, wherein the work element is a single
tube-shaped piece of material comprising a plurality of cuts
therein that defines the at least one articulable beak, the body
portion and the beak actuation portion.
3. The device of claim 1, wherein the outer tube is configured to
rotate relative to the body portion of the work element to cause
the first and second peripheral surfaces to slide against one
another and the at least one articulable beak to cyclically open
and close.
4. The device of claim 1, wherein the outer tube is configured for
limited travel in a distal or proximal direction and wherein
pulling the outer tube in the proximal direction relative to the
work element causes the middle collar element to pull the proximal
collar in the proximal direction and to close the at least one
articulable beak.
5. The device of claim 1, wherein the body portion of the work
element is configured for limited travel in a distal or proximal
direction and wherein pushing the body portion in the distal
direction relative to the outer tube causes the distal collar
element to move distally relative to the middle collar and to close
the at least one articulable beak.
6. The device of claim 1, wherein differential rotation of the body
portion relative to the outer tube cyclically opens and closes the
at least one articulable beak.
7. The device of claim 6, wherein differential rotation of the
distal and middle collars causes the first peaks and first valleys
of the first peripheral surface to slide against the second peaks
and second valleys of the second peripheral surface.
8. The device of claim 1, wherein differential axial movement of
the body portion relative to the outer tube cyclically at least
partially opens and closes the at least one articulable beak.
9. The device of claim 1, wherein a first profile defined by the
first peaks and first valleys of the first peripheral surface and a
second profile defined by the second peaks and second valleys of
the second peripheral surface define a pattern, upon rotation of at
least the collar assembly, of at least partial opening and at least
partial closing the at least one articulable beak in operation of
the device.
10. The device of claim 1, wherein a differential rotation of the
body portion relative to the outer tube defines a rate at which the
at least one articulable beak cyclically at least partially opens
and closes.
11. The device of claim 1, wherein the collar assembly is further
configured such that axially-directed pulsed movement of at least
the collar assembly causes the at least one articulated beak to
undergo a jackhammer-like reciprocating motion in at least a
partially opened or in at least a partially closed
configuration.
12. The device of claim 1, wherein a depth of the first and second
valleys and a height of the first and second peaks define a degree
to which the at least one articulable beak cyclically opens and
closes as the peripheral surfaces of the distal and middle collar
elements slide against each other.
13. The device of claim 1, wherein the first peripheral surface
matches the second peripheral surface such that the first
peripheral surface mates in intimate contact with the second
peripheral surface at least once each time one of the first and
second peripheral surfaces fully rotates around the other of the
first and second peripheral surface.
14. A method, comprising: providing a device comprising a work
element configured to rotate and defining a proximal end and a
distal end away from the proximal end, the work comprising, at the
distal end thereof, at least one articulable beak configured to cut
tissue; and a collar assembly coupled to the work element away from
the at least one articulable beak, the collar assembly comprising
at least a first collar element comprising a first peripheral
undulating surface that faces the proximal end and a second collar
element comprising a second peripheral undulating surface that
faces the distal end and that at least partially contacts the first
peripheral undulating surface, the first and second collar elements
being configured to rotate in synchronism or differentially
relative to one another; rotating the work element; inserting at
least the distal end of the rotating work element into tissue;
controlling movements of at least the first and second collar
elements to at least one of: at least partially open the at least
one articulable beak to core through tissue; at least partially
close the at least one articulable beak to dissect through tissue;
cause cyclic at least partial openings and closings of the at least
one articulable beak as the first and second peripheral undulating
surfaces slide against one another; and cause cyclic short
excursions of the at least one articulable beak toward the distal
end and back toward the proximal end in a jackhammer-like
motion.
15. The method of claim 14, wherein providing is carried out with
the work element being a single tube-shaped piece of material
comprising a plurality of cuts to define the at least one
articulable beak.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a Continuation of co-pending and
commonly-assigned U.S. patent application Ser. No. 17/153,582 filed
on Jan. 21, 2021, which is a Continuation of co-pending and
commonly-assigned U.S. patent application Ser. No. 16/000,047 filed
on Jun. 5, 2018. The present application is related in subject
matter to commonly assigned and co-pending U.S. patent applications
Ser. No. 14/864,146 filed 24 Sep. 2015 (CORSAIR2) and Ser. No.
14/599,481 filed 21 Jan. 2015 (CORSAIR2), U.S. patent application
Ser. No. 13/973,898 entitled "SOFT TISSUE CORING BIOPSY DEVICES AND
METHODS", now U.S. Pat. No. 9,155,527; U.S. patent application Ser.
No. 14/050,771 entitled "SOFT TISSUE CORING BIOSPY DEVICES AND
METHODS"; U.S. patent application Ser. No. 14/852,969 entitled
"SOFT TISSUE BIOPSY OR EXCISIONAL DEVICES AND METHODS"; U.S. patent
application Ser. No. 14/852,901 entitled "IN-SITU MATERIAL DELIVERY
DEVICES AND METHODS"; and U.S. patent application Ser. No.
14/484,122 entitled "TISSUE CORING BIOPSY DEVICES AND METHODS", the
entire disclosures of which are hereby incorporated herein in their
entirety.
BACKGROUND
[0002] Embodiments relate to medical devices and methods. More
particularly, embodiments relate to hand-held or mounted single or
multiple insertion, single or multiple excisional devices and
corresponding methods for vascular clearing and restoration
applications. Embodiments further relate to improvements over
currently used chronic total occlusion removal systems,
specifically in providing minimally invasive and more widely
capable and reliable cardio-vascular excisional devices and
methods. Embodiments further relate to improvements over currently
used orthopedic material removal systems and methods.
SUMMARY
[0003] Embodiments are drawn to various medical devices and methods
that may be used for intra-vascular and skeletal or bone marrow
biopsy procedures. According to one embodiment, an excisional
device may be configured to remove liquids, solids, semi-solids and
single or multiple material samples during a single insertion
through the skin (percutaneous procedure) into any vascular area of
the body, as well as for clearing any other occluded vessel.
Embodiments may comprise structures and functionality for different
phases of a multi-phase vascular clearing or restoration procedure,
which may be performed by hand or by device attachment to an
imaging stage. Embodiments may also comprise devices configured for
insertion through the central lumen of another compatible
excisional device. Embodiments of a device, along with associated
related subcomponents described herein, may provide the capability
to retrieve solid, contiguous and/or fragmented materials as well
as liquid and semi-solid tissues for analysis, diagnosis and
treatment and exhibit improvements in functionality and performance
relative to present devices and methods for clearing chronic total
occlusions and other vascular anomalies. Although some embodiments
may find particular utility in cardio-vascular intervention
procedures, other embodiments may also find utility in, for
instance, musculo-skeletal or neurologic applications, and are not
limited therefore to vascular applications described, shown and
claimed herein. Embodiments and elements thereof may be deployed in
interventional procedures in coronaries, including bypass vessels
(veins, internal mammary arteries, free radial grafts and in the
case of peripheral vessels, synthetic grafts, native and bypass
peripheral vessels including carotid arteries, renals, iliacs,
femorals and distal vessels including venous and arterial vessels
in various locations). Embodiments may include atherectomy and
thrombectomy devices (those that remove plaque and other components
of diseased vessel walls), which may also contain a subset that may
be used to treat both acute and chronic thromboembolic lesions and
another subset that may be used to remove restenotic "scar" tissue
obstructions (intimal hyperplastic lesions); chronic total
occlusion devices, which include a variety of devices some of which
may be considered variants of atherectomy devices and finally,
delivery devices to deliver medications, implants, and devices such
as other interventional devices performing functions listed above
as well as guiding elements including catheters and various types
of guiding and interventional wires, imaging catheters and wires,
contrast media, oxygenation elements, sensing instruments,
radiation delivery elements, protective and shielding devices,
downstream safety devices and others. Embodiments may be configured
to be portable, disposable or reusable and may be, for example,
electrically/electronically-, mechanically-, hydraulically-,
pneumatically- and/or manually-, powered, controlled and
operated.
[0004] According to one embodiment, a device for material excision
or removal from vascular or skeletal structures for either handheld
or stereotactic table use may comprise a work element or elements
configured to selectively open and close at least one articulable
beak configured to penetrate and remove intra-vascular materials or
obstructions, or follow a central lumen of another device or over a
wire in a longitudinal direction. Flush and vacuum tissue transport
mechanisms may be incorporated. An inner sheath and an outer
sheath, which may be co-axially disposed relative to a work
element, may be configured to actuate a beak or beaks for
simultaneous beak closing under rotation.
[0005] One embodiment is a device that may comprise a work element
configured to rotate and defining a proximal end and a distal end
away from the proximal end, the work element comprising a body
portion, at least one articulable beak disposed at a distal end of
the body portion and configured to cut tissue, and a beak actuation
portion; an outer tube co-axially disposed around a portion of the
work element; and a collar assembly coupled to the work element
away from the at least one articulable beak, the collar assembly
comprising at least a distal collar element coupled to the body
portion of the work element, a middle collar element coupled to the
outer tube and a proximal collar element coupled to the beak
actuation portion, the distal collar element comprising a first
peripheral surface that extends around the distal collar element
and that faces the proximal end, the middle collar element
comprising a second peripheral surface that that extends around the
middle collar element, faces the distal end and at least partially
contacts the first peripheral surface. The first peripheral surface
may be a smooth surface that comprises a plurality of first peaks
and a plurality of first valleys and the second peripheral surface
may be a smooth surface that comprises a plurality of second peaks
and a plurality of second valleys. The distal, middle and proximal
collar elements may be configured to control opening, closing,
extending and retracting the at least one articulable beak by
rotating in synchronicity, rotating differentially, moving toward
the distal end and/or moving toward the proximal end.
[0006] According to other embodiments, the work element may be a
single tube-shaped piece of material comprising a plurality of cuts
therein that defines the at least one articulable beak, the body
portion and the beak actuation portion. The outer tube may be
configured to rotate relative to the body portion of the work
element to cause the first and second peripheral surfaces to slide
against one another and the at least one articulable beak to
cyclically open and close. The outer tube may be configured for
limited travel in a distal or proximal direction and pulling the
outer tube in the proximal direction relative to the work element
may cause the middle collar element to pull the proximal collar in
the proximal direction and to close the at least one articulable
beak.
[0007] The body portion of the work element may be configured for
limited travel in the distal or proximal direction and pushing the
body portion in the distal direction relative to the outer tube may
cause the distal collar element to move distally relative to the
middle collar and to close the at least one articulable beak.
Differential rotation of the body portion relative to the outer
tube cyclically may open and close the articulable beak(s).
Differential rotation of the distal and middle collars may cause
the first peaks and first valleys of the first peripheral surface
to slide against the second peaks and second valleys of the second
peripheral surface. Differential axial movement of the body portion
relative to the outer tube may cyclically at least partially open
or close the articulable beak(s). A first profile defined by the
first peaks and first valleys of the first peripheral surface and a
second profile defined by the second peaks and second valleys of
the second peripheral surface may define a pattern, upon rotation
of at least the collar assembly, of at least partial opening and at
least partial closing the at least one articulable beak in
operation of the device. The differential rotation of the body
portion relative to the outer tube may define a rate at which the
articulable beak(s) cyclically at least partially open and close.
The collar assembly may be further configured such that
axially-directed pulsed movement of at least the collar assembly
causes the at least one articulated beak to undergo a
jackhammer-like reciprocating motion in at least a partially opened
or in at least a partially closed configuration. The depth of the
first and second valleys and the height of the first and second
peaks may define the degree to which the at least one articulable
beak cyclically opens and closes as the peripheral surfaces of the
distal and middle collar elements slide against each other. The
first peripheral surface may match the second peripheral surface
such that the first peripheral surface mates in intimate contact
with the second peripheral surface at least once each time one of
the first and second peripheral surfaces fully rotates around the
other of the first and second peripheral surface.
[0008] Another embodiment is a device, comprising a work element
configured to rotate and defining a proximal end and a distal end
away from the proximal end, the work element comprising a body
portion, one or more articulable beaks disposed at a distal end of
the body portion and configured to cut tissue, and a beak actuation
portion; a proximal sheath comprising a resilient portion near a
distal end thereof, the proximal sheath being coupled to the beak
actuation portion of the work element; a distal sheath partially
disposed over the work element and coupled to the proximal sheath
distally relative to the resilient portion thereof; and a collar
assembly coupled to the work element away from the articulable
beak(s), the collar assembly comprising at least a first collar
element coupled to the body portion of the work element and a
second collar element coupled to the distal sheath, the first
collar element comprising a first peripheral surface that extends
around the first collar element and that faces the proximal end and
the second collar element comprising a second peripheral surface
that that extends around the second collar element, faces the
distal end and at least partially contacts the first peripheral
surface. The first peripheral surface may be a smooth surface that
comprises a plurality of first peaks and a plurality of first
valleys and the second peripheral surface may be a smooth surface
that comprises a plurality of second peaks and a plurality of
second valleys. The proximal sheath, the distal sheath and the
collar assembly may be configured to control opening, closing,
extending and retracting the articulable beak(s) by rotating in
synchronicity, rotating differentially, moving toward the distal
end and/or moving toward the proximal end.
[0009] According to further embodiments, the work element may be a
single tube-shaped piece of material comprising a plurality of cuts
therein that defines the at least one articulable beak, the body
portion and the beak actuation portion. Differential rotational
motion of the distal tube and of the proximal tube may be
configured to cause the first and second peripheral surfaces to
slide against one another and the articulable beak(s) to cyclically
open and close. The distal tube may be configured for limited
travel in a distal or proximal direction and pulling the distal
tube in the proximal direction relative to the work element may
cause the second collar element to pull the proximal sheath in the
proximal direction and to close the articulable beak(s).
Differential rotation of the distal tube relative to the proximal
tube may cyclically open and close the articulable beak(s).
Differential rotation of the first and second collars causes the
first peaks and first valleys of the first peripheral surface to
slide against the second peaks and second valleys of the second
peripheral surface. Differential axial movement of the distal
sheath relative to the proximal sheath may cyclically at least
partially open and close the articulable beak(s).
[0010] A first profile defined by the first peaks and first valleys
of the first peripheral surface and a second profile defined by the
second peaks and second valleys of the second peripheral surface
may define a pattern of at least partial opening and at least
partial closing the articulable beak(s) in operation of the device.
A differential rotation of the distal sheath relative to the
proximal sheath may define a rate at which the articulable beak(s)
cyclically at least partially open and close. The distal sheath may
be configured such that a periodic axial movement thereof causes
the articulated beak(s) to undergo a jackhammer-like reciprocating
motion in at least a partially opened or in at least a partially
closed configuration. The depth of the first and second valleys and
the height of the first and second peaks define a degree to which
articulable beak(s) cyclically open and close as the peripheral
surfaces of the first and second collar elements slide against each
other. The first peripheral surface may match the second peripheral
surface such that the first peripheral surface mates in intimate
contact with the second peripheral surface at least once each time
one of the first and second peripheral surfaces fully rotates
around the other of the first and second peripheral surface.
[0011] According to one embodiment, a method may comprise providing
a device comprising a work element configured to rotate and
defining a proximal end and a distal end away from the proximal
end, the work comprising, at the distal end thereof, at least one
articulable beak configured to cut tissue; and a collar assembly
coupled to the work element away from the at least one articulable
beak. The collar assembly may comprise at least a first collar
element comprising a first peripheral undulating surface that faces
the proximal end and a second collar element comprising a second
peripheral undulating surface that faces the distal end and that at
least partially contacts the first peripheral undulating surface,
the first and second collar elements being configured to rotate in
synchronism or differentially relative to one another. At least the
work element may then be rotated and at least the distal end of the
work element inserted into tissue. The movements (rotational,
axial) of at least the first and second collar elements may then be
suitably and selectably controlled to at least partially open the
articulable beak(s) to core through tissue; at least partially
close the articulable beak(s) to dissect through tissue; cause
cyclic at least partial openings and closings of the articulable
beak(s) as the first and second peripheral undulating surfaces
slide against one another; and/or cause cyclic short excursions of
the articulable beak(s) toward the distal end and back toward the
proximal end in a jackhammer-like motion.
[0012] In one embodiment, providing may be carried out with the
work element being a single tube-shaped piece of material
comprising a plurality of cuts to define the articulable
beak(s).
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is a perspective side view of an excisional device,
according to one embodiment.
[0014] FIG. 2 shows a monolithic beak assembly of an excisional
device according to one embodiment.
[0015] FIG. 3 shows a detail of a proximal end of a monolithic beak
assembly of an excisional device according to one embodiment.
[0016] FIG. 4 shows the distal end of a proximal sheath of an
excisional device according to one embodiment.
[0017] FIG. 5 shows an assembly comprising a monolithic beak
assembly and a proximal sheath of an excisional device according to
one embodiment.
[0018] FIG. 6 shows the distal end of a distal sheath of an
excisional device, according to one embodiment.
[0019] FIG. 7 shows an assembly comprising a monolithic beak
assembly, a proximal sheath and a distal sheath, according to one
embodiment.
[0020] FIG. 8 shows the distal portion of an excisional device
according to one embodiment.
[0021] FIGS. 9A and 9B illustrate details of a collar actuation
mechanism of a work element of a device, according to one
embodiment.
[0022] FIGS. 10A and 10B show elements and features of a single
flexible tube work element with double articulable beaks or
scoopulas, according to embodiments.
[0023] FIG. 11 shows elements of a double tube work element
proximal end, according to one embodiment.
[0024] FIG. 12 shows a flexible, coated helical structure for a
tube element of a work element, according to one embodiment.
[0025] FIG. 13 shows a flexible, axially-constrained tube element
of a work element, according to one embodiment.
[0026] FIGS. 14A and 14B show details of a work element, according
to one embodiment.
[0027] FIG. 15 shows details of a work element, according to one
embodiment.
[0028] FIG. 16 shows details of a driving mechanism, according to
one embodiment.
[0029] FIG. 17 is a representation of an innermost monolithic
structure comprising a pair of beaks, a middle tubular/helical
structure and an outermost tubular scoopula, according to one
embodiment.
[0030] FIG. 18 is a representation of an innermost tubular/helical
structure comprising a beak and components shown, a middle
tubular/helical structure and an outer scoopula, according to one
embodiment.
DETAILED DESCRIPTION
[0031] Reference will now be made in detail to the construction and
operation of implementations of the embodiments illustrated in the
accompanying drawings. The following description is only exemplary
of the embodiments described and shown herein. The embodiments,
therefore, are not limited to these implementations, but may be
realized by other implementations.
[0032] According to embodiments, a device for material or tissue
excision may be configured to remove intra-vascular or other
materials in the fields of, for example, cardio-vascular,
orthopedic or neurologic intervention, particularly wherein a
system capable of cyclic morcellation in concert with or without
cyclic forward jack-hammer motion, any combination of which may be
under rotation at any appropriate speed, and removal of hard or
soft tissue materials may be desirable, and may comprise a range of
work element dimensions ranging from, for example, approximately
0.0065'' to 0.249'' diameter (1/3 French to 19 French), or other
appropriate dimensions both larger and smaller depending on
applications and field of use requirements. According to
embodiments, an excisional device may comprise a generally flexible
tubular structure, which may be at least partially disposed within
a coaxially-disposed outer tube or tubes, which outer tube or tubes
may comprise a fixed or removable distal scoopula(s) or beak(s). A
work element, according to one embodiment, may comprise one or more
scoopulas and/or one or more beaks. Either may be fixed or
articulable, sharpened or unsharpened at their tips or along their
side axes, and combinations of the two may be interchanged,
according to embodiments. In the case of either articulable beaks
or scoopulas, the principles of action as described herein and
according to embodiments may be similar or different to that used
for one relative to the other.
[0033] Beak (distal working end) actuation for the purposes of
cycling between closed-state (for penetration and part-off) and
wide open state (for coring and capturing tissue sample) while
rotating can be accomplished with a push-pull mechanism that
originates in a driving assembly far proximal to the beak
structures themselves so long as the connection between a proximal
driver and the movable structures including the movement of living
backbone hinge elements relative to living hinge tendon/keystone
elements of the beaks, is comprised of relatively rigid structures
that can transmit small movements precisely, relying on column
strength structural integrity combined with relatively inelastic
tension structures to transmit these direct, linear forces over the
length between the beaks and driver mechanism. This mechanism is
successful for instruments that can rely on relatively rigid
members between handle (driver) and working end but in the event
the application requires a relatively long flexible catheter
between driver (handle end) and working end, a simple proximal
push-pull motion that is then required to be transmitted in a
linear way along a tortuous pathway may be problematic. In fact,
there are several factors that render linear motion transmission
along the length of a flexible catheter undesirable as a way to
transmit the precise forces needed to actuate the beak mechanisms
to cycle between fully open and closed, since these distal motions
may be as small as several thousandths of an inch, particularly
when the catheter is forced into curves needed to gain access to a
treatment site. As a result, it is highly advantageous to generate
the push-pull forces needed to actuate the beaks locally, that is,
as near the actual living-hinge backbone and living tendon members
as possible, using forces that are less affected by flexing the
catheter over or through which these forces are transmitted. One
such exemplary mechanism is described below, although the important
and basic concept is to utilize a mechanism that allows significant
flexing of the catheter connecting driver and working distal end,
while providing forces that may be converted to small, precise,
repeatable linear push-pull forces locally--that is, at the distal
end very near to keystone and backbone elements, the relative
motion of which cycles open and closed the beak element(s)--while
also enabling powered rotation of the beak elements for penetration
(closed beak), coring (open beak), and part-Page off/transport
(closed beak). It is also desirable to permit an open core
transmission section between beak elements and storage chamber
proximal to the driving mechanism. The exemplary mechanisms
presented below fulfills these requirements although any other
mechanism that also fulfills this specification would be considered
of the same basic concept described.
[0034] Herein, beaks may refer to that portion of a work element
whose primary functions may comprise coring, shaving or grasping to
remove material, and may also be fixed, articulable, sharpened or
unsharpened, and may have various features and shapes according to
various embodiments. Beaks may comprise longitudinal living hinge
elements such that the beaks may be expanded "out of round" to a
more flattened shape, or alternatively a more tubular shape than
when at rest. Beak driving assembly or assemblies in the device may
have operating characteristics and features to enable rotational
speeds advantageously chosen to optimize "sweep" ultrasound imaging
using mechanical array or at a different speed to increase the
information provided with phased array imaging, for example and may
include longitudinal and "off angle" sweep capabilities as they are
articulated to "shine" ultrasound or light energy at various
structures of interest. These capabilities can also be used to
receive signals in return and/or for reference signal processing.
These capabilities can also be used together with "light out, sound
in" systems that combine light and sound efferent and afferent
signal processing to increase information available using a
combination of these modalities. These rotational, longitudinal
"pullback" and angular speeds may be generally in the same range as
useful cutting, pullback/advancement and angular speeds, or they
may be outside that normal range and activated separately for
diagnostic or other therapeutic procedures (radiation delivery,
medication "painting", injecting or other delivery). Driving
assembly or assemblies (hereafter, collectively "driving assembly"
for ease of reference) for beaks may be controllable at the handle
end of the device (e.g., outside the body) and can be quite
sophisticated, reusable and electronically optimized for torque,
rotational speed (rpm) and frequency (in the cases of translation,
angular changes and oscillation motions). The driving assembly may
also comprise variable control as needed and may also include the
ability to halt work element motions at a part-off phase (a phase
at which a cut or cored piece of tissue or material is separated
from surrounding tissue), with automated rearward (proximal)
translation for purposes of delivering excised materials (e.g.,
pieces of tissue or material) to a transport portion of the device
where, according to one embodiment, vacuum along with fluid
management flows and swirls may complete the rearward delivery into
a serial collection magazine of the device, and according to
another embodiment, such vacuum and flush systems may be augmented
with internal helice(s) or Archimedes screw type augers or variants
thereof, as may be envisioned by one skilled in the art. Driving
mechanisms may also include delivery of electrical, mechanical,
radiant, ultrasonic, electromagnetic, electron beam and simple
magnetic, among other, energies distally to a work element area,
whereby conversion or re-conversion to another energy form may be
made in the work area. As examples, electrical energy may be
delivered to a receiving electromagnetic device to mechanically
actuate a distal element, or turbine power generated may be
transmitted distally via inert gases or mechanical spinning of
elements acting directly on a distal element or simply via fluids
that may be present or introduced in the presence of spinning
elements according to embodiments, that may function to both create
vacuum at the distal work element area while also creating
mechanical motion in another or the same element, such as a high
speed, low torque rotational element such that simultaneous
dissolution and sucking of debris such as clotted blood or
particulate matter rearward and safely out of the work area may be
accomplished. Yet another example is that an e-beam sent distally
may be directionally by elements in the work area in which case
energy is precisely redirected and focused by embodiments, rather
than converted to another form of energy per se. Multiple energies
such as "light in, sound out" technologies among others, combining
more than one modality to interrogate an area and supply more
detailed information based on the modalities utilized in such a
combination may be, at the same time, delivered, received and in
some cases advantageously altered by elements of the present
embodiments.
[0035] It is to be noted that, herein, the phrase "helical element"
and the terms "helix" or "helices" are intended to encompass a
broad spectrum of structures. Indeed, the structures shown herein
are but possible implementations of a helical element, helix or
helices. According to other embodiments, "helical element", "helix"
or "helices" and equivalent expressions may be implemented as tubes
having one or more slot-shaped openings or fenestrations along at
least a portion of the length thereof. Such fenestrations may be
substantially parallel to the longitudinal axis of a tube or may be
disposed, for example, in a spiral configuration. The fenestrations
may be continuous along at least a portion of the length of a tube
or may be discontinuous, such as to result in a plurality of such
parallel or spirally wound fenestrations. The fenestrations may be
very wide such that the resultant structure resembles a spring, or
more narrow, such that the resulting structure more closely
resembles a tube having narrow, slot-shaped openings therein. The
continuous or discontinuous fenestrations may be caused to assume
other configurations along at least a portion of the tubes in which
they are formed. For example, the fenestrations may be caused to
form a zigzag pattern such as "NNNN . . . ", "", "WAN" or "VVVV . .
. " or a cross-shaped pattern, such as "XXXXX". Significantly, the
terms "helical element," "helix," or "helices" should be understood
to cover a spectrum of structures, from a spring-like structure to
tubes having selected slot-shaped openings, with such tubes
exhibiting rigid or flexible portions along their lengths.
[0036] Embodiments of devices comprising variations of scoopula(s)
may be configured to isolate the working surface(s) from the flow
surfaces. In use in a vascular lumen, for example, this means that
the lumen and/or potential lumen (tight stenoses and complete
occlusions, whether chronic or acute) space will be protected
before and additionally as soon as there is sufficient space to
permit blood flow, including gently forced flow for the purposes of
downstream oxygenation and nutrition, introduction of imaging
equipment, and natural flows based on driving pressures relieved by
new or widened lumens. This space (the lumen space) is isolated
from the working space so that any elements that are released
during removal actions will be prevented from impairing flow in the
protected flow lumen of the vessel being widened in caliber. This
space will be utilized such that vacuum may be maximized in the
working side of the vessel as defined by the scoopula, and also in
certain embodiments, while protecting the flow side--an embodiment
may simultaneously press against the wall on the flow side
(opposite to the working side) causing the working side of a
catheter to be pressed against the lesion side of the vessel so
that the elements on the working side of a device may be held
precisely at the desired depth (for example for removing as much or
little of a lesion as may be optimal for various considerations
such as transport, degree of aggressiveness, rate of removal,
particulate size of the material being removed, as the working beak
element(s) are given purchase). Embodiments also provide a stable,
geometrically straight reference platform. This reference platform
may be used to straighten a desired segment of a vessel such that a
uniform depth of lesion material may be safely removed without the
concern for asymmetrically removing deep-wall elements (for example
in an otherwise naturally or as a result of disease, tortuous
section of a vessel) that may lead to weakening, aneurism formation
or even perforation during the procedure.
[0037] As used throughout this disclosure, work elements may
comprise one or more tubes, and the terms "inner" and "outer" tubes
may be used with reference to a single work element, or in
reference to two or more co-axially located work elements (or
"complex work elements", as used herein), each of which may
comprise one or more tubes to enable their specific function. A
coaxially-disposed outer tube, according to one embodiment, may
also comprise one or more coatings. According to one embodiment, a
tube may comprise a stainless-steel hypodermic tubing ("hypo
tube"). Such a stainless hypo tube, according to one embodiment,
may be provided with (e.g., laser) cuts to define a monolithic
distal assembly that defines beaks, a living hinge that attaches
the beak(s) to the generally tubular body of the device or that
homogeneously spans between the beak(s) and the generally tubular
body of the device. According to one embodiment, cuts in the hypo
tube may define one or more tendons configured to actuate the
beak(s). The cuts in the hypo tube may also define one or more
tendon actuation tabs or body portion actuation tabs that enable
actuation (e.g., opening and closing) the beak(s) through the
tendons or body portion, according to embodiments, and limit the
travel thereof. The tendon actuator tab(s) or body portion tab(s)
may be located at any location along the length of the hypo tube.
According to one embodiment, portions of the tube may be rigid.
According to another embodiment, laser cuts along the proximally
extended body portion of the tube may enable flexibility over its
entire length or one or more portions thereof. The device may also
comprise materials other than stainless steel, such as plastics or
other suitable materials, which may incorporate the features of the
beak(s), tendon(s), and, according to embodiments, tendon actuation
tab(s) or an internal tube actuator element. This device may be
used by itself or may be used in conjunction with or inside another
excisional device with an open central lumen, through which it may
introduced to attack a target tissue site.
[0038] FIG. 1 shows an excisional device 10 according to
embodiments, having a tubular coring and transport assembly 11
(also called an "outer tube," "non- or differentially-rotating
outer sheath," "flexible sheath" or "outer sheath" herein,
depending on embodiments) of appropriate dimensions to retrieve a
single or multiple morcellated or elongated core samples of tissue
(not shown) that is or are sufficient to provide the desired
clinical diagnostic or therapeutic result. Such an appropriate
dimension may be, for example, about 6-40 inches in length, in
addition to a forward excursion of a tubular coring and transport
assembly 11 during the morcellating/pulsing/coring phases. It is to
be understood, however, that the foregoing dimensions and any
dimensions referred to herein are exemplary in nature only and are
not limiting factors. Those of skill in this art will recognize
that other dimensions and/or configurations may be implemented,
depending upon the application, and that a tubular coring assembly
and its subparts could be of any length.
[0039] One embodiment of the excisional device 10, as shown in the
figures, may be implemented in a hand-held configuration comprising
an ergonomically comfortable and secure handle 12 at its proximal
end from which a tubular coring and transport assembly 11 extends
so that the device 10 may be easily directed with one hand while
the other hand is free to hold a guiding probe such as an
ultrasound transducer. However, it is to be understood that
embodiments may readily be configured to fit onto any number of
guiding devices such as a stereotactic imaging stage or other
guidance modality such as MRI (not shown). As shown, one embodiment
of the device 10 may comprise one or more sharp, rotating cutting
elements 13 (herein, alternatively and collectively referred to as
"work element", "beak", "beak assembly" or "beak element" or "beak
elements") projecting forward distally from the distal free end of
the tubular coring and transport assembly 11 for the purpose of
forward penetration, morcellation, coring and parting off of a
cored sample in a simple point and shoot procedure. A tubular
coring and transport assembly 11 may comprise a plurality of
components, which plurality may be configured to transmit
rotational movement to rotating cutting elements 13, as well as
short excursion forward pulsed movement in a puncturing or
"jackhammer" motion. It is to be understood that the "tubular"
description of a coring and transport assembly may be of any
cross-section shape and size, of any length. The components of a
tubular coring and transport assembly 11 also transfer collected
tissues and fluids back proximally along the internal length of an
inner lumen of a tubular coring and transport assembly 11 to a
handle 12 and storage compartment or a transfer magazine 27.
According to one embodiment thereof, the device 10 may comprise a
handle or handle 12, which handle or handle 12 may comprise and/or
be coupled to mechanical components (not shown in this figure)
needed to drive a morcellation/pulsed
puncturing/coring/transport/part-off/delivery distal tubular coring
and transport assembly 11. As shown, one embodiment may comprise a
distally-disposed beak 13 that may comprise one or more sharp
cutting tip blades to penetrate to the target site of the intended
biopsy or intervention, morcellate and core the target tissue and
part-off or cut off a hard or soft tissue sample (not shown) at its
base or at any desired point along the length of a core sampling.
The ability of the present device to repeatedly puncture,
morcellate, core and retrieve multiple samples (not shown) during a
single insertion and then store the cored samples in a transfer
magazine 27 or other storage container means that with a single
penetration through the skin of, for example, the thigh and femoral
artery, the operator can sample multiple areas without causing
additional trauma that would be associated with having to remove
the device 10 each time a sample is taken, and reintroducing the
device 10 back into the patient to take additional morcellated or
cored samples. A handle 12 may also contain and/or be coupled to
(internal or external) mechanical components (not shown) for
vacuum-assisted fluid evacuation as well as the delivery of
materials such as, for example, a variety of flushes, medications,
tracer materials and/or implantable marker elements (not shown). A
distal tubular coring and transport assembly 11, according to one
embodiment, may be configured such as to create the smallest
possible caliber (e.g., diameter) of coring tube (tubular coring
and transport assembly 11) with a range of (for example) about 16
gauge or 0.065 inches in diameter to about 1 inch or more diameter,
while providing a sufficiently large diameter of core sample to be
clinically useful. A tubular coring and transport assembly 11 may
also be constructed of flexible materials and/or of a sufficient
length to reach distant target sites from the skin surface without
the need for a surgical procedure to enable the distal end (that
end thereof that is furthest from a handle 12) of the device 10 to
reach the targeted site. In the embodiment of FIG. 1, a distal
tubular coring and transport assembly 11 of the device 10 may
extend distally from a handle 12 to a distance sufficient to create
a tissue core (not shown) for diagnosis and/or treatment purposes.
As is described below, this distance of forward or distal
projection can be selectively changed at will, thanks to structure
configured for that purpose, which may be built into or otherwise
coupled to the present device 10. Embodiments of the present device
10 may be used by right and/or left-handed persons and in multiple
positions and orientations so that in areas of limited access the
present device may still be easily positioned for ideal orientation
to perform an excisional procedure under real time or other image
guidance (not shown). The entire device may be configured to be
disposable or may be configured to be reusable in whole or in part.
Embodiments of the present device 10 may be electrically powered by
one or more batteries (not shown in this figure) and/or external
power sources (not shown in this figure) through a simple
electrical coupling to connect to an external power supply
conveniently placed, for example, in a handle or proximal end of
the present device. The entire device may also be internally or
externally manually powered, mechanically powered or be powered by
means such as compressed air, gas or pressurized fluid. Powering
the device entirely mechanically may be advantageous in areas in
which the electric grid is absent, unavailable, or unreliable.
[0040] FIGS. 2 and 3 show details of components of a work element,
according to one embodiment. Attention is drawn to the proximal end
of a work element 13. Therein, a body portion 428 of a work element
13 may be mechanically coupled to tendon actuating element 469 at
the proximal end of a work element. Note that a tendon actuating
element 469 is already coupled to a body portion 428 through
tendons 468, 470, toward the distal end of a work element 13. That
is, an entire work element 13 may be formed of a single homogeneous
material--such as from a single hollow tube that is (for example)
laser-cut to form the structures shown in FIGS. 2 and 3. Two beaks
are shown. It is to be understood, however, that such need not be
the case, as a work element 13 may comprise multiple beaks or a
single beak that acts against a non-moveable part, such as a fixed
trough-shaped distal portion of a distal sheath or against a fixed,
opposing beak that is part of a work element 13 itself.
[0041] According to one embodiment, as shown in FIGS. 2 and 3, the
proximal end of a tendon actuating element 469 may be mechanically
coupled to the proximal portion of a body portion 428. Such
mechanical coupling may be configured to maintain a tendon
actuating element centered on the cutout in a body portion formed
to accommodate a tendon actuating element 469 and/or to provide
additional biasing force in the distal direction, as well as to aid
in manufacturing. One embodiment comprises a resilient member 427
having one end thereof coupled to a tendon actuating element 469
and another end thereof coupled to a proximal portion of the work
element 13. Such a resilient member 427 may be configured to bias
the beak or beaks of a work element 13 in the open configuration,
such that a sufficiently great proximally-directed force applied to
a tendon actuating element 469 tends to close a beak or beaks.
Conversely, release of such proximally-directed force causes a
resilient member 427 to release the energy stored during the
extension thereof and return to its un-extended state, thereby
exerting a distally-directed force on a tendon actuating member
469, which causes a beak or beaks to return to its or their default
open configuration.
[0042] Also shown in FIG. 3, attachment holes 292A and 292B may be
provided on a body portion 428 and on a tendon actuating element
469, respectively. Such attachment holes 292 may, according to one
embodiment, indicate the location of, for example, spot welds, as
detailed below.
[0043] FIG. 4 shows a distal portion of a proximal sheath according
to one embodiment. A proximal sheath 300, as shown in FIG. 4 may
comprise a number of fenestrations or slots 304 that run through
the wall of a proximal sheath 300, from an outer surface to an
interior lumen thereof. The distal portion of a proximal sheath 300
may be configured to fit over and attach to the proximal end of a
monolithic beak assembly 13 of FIGS. 2 and 3. During assembly of
the present excisional device and as shown in FIG. 5, attachment
holes 308A and 308B of a proximal sheath 300 may be lined up with
attachment holes 292A and 292B, respectively, of a monolithic beak
assembly 13, as illustrated in FIGS. 2 and 3. A proximal sheath
300, which may be flexible along its length, may thus be attached
to a monolithic beak assembly 13 at attachment points 292A, 308A
and 292B, 308B. According to one implementation, an attachment
point 308A of a proximal sheath 300 may be spot-welded to an
attachment point 292A of a tendon actuating member 469 of a
monolithic beak assembly 13. Although not shown in these figures,
corresponding attachment points may be provided on the hidden side
of the device. Similarly, an attachment point 308B of a proximal
sheath 300 may be spot-welded to an attachment point 292B of a body
portion 428 of a monolithic beak assembly 13. As also shown in FIG.
4, the distal portion of a proximal sheath 300 may define a
resilient or spring portion, as shown at reference numeral 306.
[0044] FIG. 6 shows the distal portion of a distal sheath 320,
according to one embodiment. A distal sheath 320, which may also be
flexible along its length, may be configured to fit over a proximal
sheath 300 and an attachment point 326 of a distal sheath 320
attached to attachment point 310 on a proximal sheath 300, as shown
in FIGS. 5 and 7. For example, an attachment point 326 of a distal
sheath 320 may be spot-welded to attachment point 310 on a proximal
sheath 300, as suggested in FIG. 7. A distal sheath 320 is
transparently illustrated in FIG. 7, to show underlying detail. It
is to be understood that spot-welding is but one method of
attaching constituent components of the present excisional device
to one another. Other attachment technologies may also be used, as
appropriate. Once a distal sheath 320 is spot welded in place, it
will rotate in synchronicity with a beak assembly 13 and proximal
sheath 300, but will be able to move axially relative to proximal
sheath 300, according to one embodiment. Such axial movement
between distal and proximal sheaths will positively open and/or
close a beak or beaks of monolithic beak assembly 13, as previously
discussed. As will be discussed further below, such a structure may
also incorporate collar elements, in which case the attachment
points of the distal sheath to such collar elements and at least
one of the collar elements to the beak assembly 13, according to
other embodiments. It should be noted that, according to
embodiments, the distal sheath 320 may extend distally beyond the
attachment points 326 to at least partially cover the monolithic
beak assembly of FIGS. 2, 3 and 5, and may extend nearly to the
beak tips, according to one embodiment.
[0045] FIG. 8 shows one embodiment of the present excisional
device, in a still further intermediate state of assembly. In FIG.
8, an outer sheath 330 has been fitted over an assembly comprising
a monolithic beak assembly 13, a proximal sheath 300 and a distal
sheath 320, according to one embodiment, or over an assembly
comprising a monolithic beak assembly 13, a proximal sheath 300 and
a simple collar, according to another embodiment. For example, an
outer sheath 330 may comprise polyimide or may comprise or be
formed of stainless steel among other suitable materials. An outer
sheath 330 may be configured to be manually rotating, non-rotating,
or at least differentially-rotating with respect to an assembly
comprising a monolithic beak assembly 13, a proximal sheath 300 and
a distal sheath 320 and may further be configured to be removable.
That is, in this embodiment, while an assembly comprising a
monolithic beak assembly 13, a proximal sheath 300 and a distal
sheath 320, if included according to embodiments, may rotate at
relatively high rates of speed (in the thousands of revolutions per
minute, for example), an outer sheath 330 may be held either
stationary or rotated as needed. This may be accomplished manually
or otherwise actuated by any mechanical means. For example, the
user may rotate an outer sheath 330 a few tens of degrees at a
time, as and when the procedure requires, and may remove or replace
it before, during or after a procedure. An outer sheath 330 may
extend distally to beaks of a monolithic beak assembly, may expose
a greater proportion of a monolithic beak assembly 13 or may cover
a significant portion of beaks, which may be controlled during use,
according to embodiments. Different distal shapes at the end of the
outer sheath 330 may be incorporated, according to further
embodiments, and may include scoop-shaped or castellated
configurations.
[0046] According to one embodiment, an outer sheath 330 may be
dimensioned so as to allow an annular space to exist between the
inner wall of an outer sheath 330 and the combined outer surfaces
of a distal sheath 320 and distal portion of a monolithic beak
assembly 13. This annular space may allow for flush to be
introduced at selected stages in the procedure. The flush may
provide lubrication for the rotation of an assembly comprising an
assembled monolithic beak assembly 13, a proximal sheath 300 and a
distal sheath 320, and may facilitate the rotation and thus the
transport of the cored and severed tissue specimen in the distal
direction. According to one embodiment, when the beak or beaks of a
monolithic beak assembly is or are in the open configuration,
fenestrations or slots 304 (FIG. 4) defined in a proximal sheath
300 are not lined up with fenestrations or slots 324 (FIG. 6)
defined in a distal sheath 320. However, according to one
embodiment, when beak or beaks are actuated, and beaks are closing,
are closed or are substantially closed, then fenestrations or slots
324 defined in a distal sheath 320 become lined up (or
substantially lined up) with corresponding fenestrations or slots
304 defined in a proximal sheath 300. In this state, if there is
flush in an annular space between the outer surface of a distal
sheath 320 and the inner wall of an outer sheath 330, this flush
will enter the interior lumen of the device (where the cored and
severed tissue specimens are collected and are transported).
Moreover, as the flush may have been entrained into rotation in an
aforementioned annular space as the assembly comprising a
monolithic beak assembly 13, a proximal sheath 300 and a distal
sheath 320 rotates, the rotating flush may enter this interior
lumen with some force and may exert that force on any cored and
severed tissue specimen therein. This flush may act as a lubricant
as well to the specimen contained in the inner lumen of the device.
According to one embodiment, a vacuum may be drawn within the
interior lumen of the device. According to one embodiment, the
vacuum force imparted on the cored and severed tissue specimen,
alone or together with force imparted on such specimen by flush
entering this interior lumen, draws and transports the cored and
severed tissue specimen in the proximal direction, for eventual
transport to a transfer magazine 27, for example.
[0047] Transport of cored tissue specimens may be aided by a
shoulder shown at 332 in FIG. 8. Indeed, such shoulder encompasses
the location defined by the proximal end of a monolithic beak
assembly 13 and the distal end of a proximal sheath 300 as well as
the distal end of a distal sheath 520 or a simple collar attached
to the beak assembly. As the diameter of a proximal sheath 300 is
somewhat greater than that of the proximal end of a monolithic beak
assembly 13, the interior lumen of a proximal sheath 300 is
correspondingly larger than the interior lumen of a monolithic beak
assembly 13, and the interior lumen of a proximal sheath thus
serves as an expansion chamber or, according to embodiments, as a
stop barrier for a collar to act against under rotation or not. As
the cored and severed tissue specimen(s) enters the interior lumen
of a monolithic beak assembly 13, the tissue specimen(s) may be
somewhat compressed. Such compression may be somewhat relieved as
the tissue specimen(s) transitions from the lumen of a monolithic
beak assembly 13 to the somewhat greater diameter lumen of a
proximal sheath 300, at shoulder 332. This decompression of the
tissue specimen(s) in the lumen of a proximal sheath 300 may,
together with flush and/or vacuum, also facilitate tissue
transport. A shoulder at 332 could expand an inner lumen diameter
in the range of 0.001 inch to 0.100 inch additional over an
original lumen diameter, or double a lumen diameter, whichever is
greater. As previously mentioned, shoulder features may be
incorporated into a proximal sheath, distal sheath and outer sheath
to augment such tissue expansion/transport action. As previously
mentioned may be the case, such an embodiment may or may not
incorporate a first helical element (transport helix which may be
in the form of an Archimedes screw) or may instead be constituted
of co-axially disposed helices, for example, in the form of a
proximal sheath and a distal sheath, which, aided by flush and/or
vacuum, may efficiently transport tissue specimens axially to a
transfer magazine at the proximal end of the device 10.
[0048] According to one embodiment, flush may be incorporated in
the annular space between an outer sheath (which may actually take
the form of either a distal sheath 590 or an outer sheath) and
inner sheath(s), to facilitate tissue transport. Vacuum may be
drawn within the central lumen of a whole tubular coring and
transport assembly 11, to facilitate tissue transport as well as
flush fluid transport. This enables an operator to collect any
fluids from the penetration and biopsy or intervention sites during
the procedure in order to help with visualization under various
guidance modalities and to collect cells for cytological analysis.
Moreover, according to one embodiment, such a flush pathway enables
the delivery of, for example, biologically active substances and/or
markers.
[0049] Coupled with flush and vacuum, fenestrations defined in a
proximal sheath and a distal sheath may enable a helical "pumping"
feature and create a reservoir of fluids surrounding the tissue,
which may enable a swirling wave action to interact with the cored
and severed tissue samples to gently push them in the proximal
direction. Such fenestrations may also lessen respective wall
surface areas of these structures and thus decrease the surface
friction experienced by the cored and severed tissue sample. Such
structures also exhibit a favorable "sealing" effect surrounding
the tissues, particularly where irregular tissues might, based on
their own surface architecture, engender vacuum leaks. Indeed, the
gentle urging of such transportation of the cored and severed
tissue samples preserves the underlying tissue architecture and
delivers a clinically-useful sample (e.g., one whose tissue
architecture has not been unacceptably damaged during its
transport) to, for example, a transfer magazine 27.
[0050] FIGS. 9A and 9B illustrate details of a collar 532 actuation
mechanism of a monolithic work element of a device according to one
embodiment. Such a collar may be attached to a tendon actuation tab
526, as well as a body portion 528 of a work element, and provides
for differential axial movement of a tendon 522, for example, in
relation to a body portion 528 of a work element 13, thus allowing
for beak actuation. In this figure, a collar 532 may be comprised
of three sub-elements, 532a, 532b and 532c, the most distal of
which (532a) may be attached to, for example, a body portion 528 of
a work element, the middle collar (532b) attached to a co-axially
placed outer tube 531, and the most proximal collar (532c) attached
to the tendon actuation tab 526. If the outer tube is rotated in
relation to the work element, the sinusoidal or other form of wave
around the periphery of the adjacent-most distal collar and middle
collar will provide relative axial motion between the body portion
528 of the work element and the tendon actuation tab 526 of the
work element, thus actuating the beak tip(s) without allowing the
beak tips to twist in relation to one another. Such a configuration
may be advantageous in allowing for beak actuation wherein the
proximally extended body portion 530 of the inner monolithic work
element tube may be, for example, over 3 feet in length and
flexible over its length as may commonly be associated with
vascular intervention devices. An outer tube 531, which may also be
flexible in construction (such as shown in FIG. 9A by the helical
structure, but with an opposite twist, for example), would
therefore still efficiently translate rotation along its entire
length in relation to the inner work element flexible body portion,
allowing efficient remote actuation of the work element at its
distal end. It should also be noted that if the outer tube 531 is
pulled axially in a proximal direction while the work element 13 is
stationary, then the middle collar 532b will pull the proximal
collar 532c in a proximal direction as well, resulting in the beaks
closing. Similarly, if the body portion 528 is pushed distally
while the outer tube 531 is stationary, the beaks will also close.
Such a configuration allows the beaks to be actuated either as a
result of differential rotation of the body portion 528 and outer
tube 531, or by relative axial motion between those two structures.
Finally, it should be noted that outer tube 531 may extend distally
beyond its connection or weld points to the middle collar 532b such
that it may cover the beaks 524 nearly to their very tips for
efficient tissue coring purposes, according to embodiments.
[0051] Such a configuration of the three collar sub-elements may
also be applied to the work element of FIGS. 4 through 7 above, in
which case the distal most collar, 532a may be attached to the body
portion 428 of the work element, collar 532b may be attached to the
distal tube 320 of FIG. 6, and the proximal tube 302 of those
illustrations may take the place of collar element 532c, for
example, and according to another embodiment. In this embodiment,
the proximal tube 300/302 is attached to the base of the work
element along the body portion 428 by weld points 308B and 292B,
and the flexible portion 306 of the proximal tube and the distal
most extension of that tube would butt up against the collar 532b
and is of the same diameter as the collar elements 532a and 532b.
The middle collar 532b is attached to the distal tube 320 at weld
points 326 and 310 of FIG. 7, extending forward of the distal end
of proximal tube 300/302 of FIG. 5, and the distal-most collar 532a
would be attached to the body portion 428 of the work element
distal to collar 532b; would be the same diameter as collar 532b
and the distal end of the proximal tube 300; and would thus serve
as a hard stop against which any relative rotational motion between
the proximal and distal sheaths 300 and 320, respectively, will
serve to actuate the beaks of the work element by acting on the
tendon actuation member 469 as the sinusoidal or other form of a
wave or waves of elements 532a and 532b of FIG. 9b are rotated
against each other. In such embodiments as those in this paragraph
and the previous FIG. 9B, the proximal and distal tubes need not
rotate in synchronicity, but may rotate in relative rotational
speeds. Such a relative rotational motion enables a periodic
flexing of the beaks of the work element, which may result in the
beaks being closed completely, partially, or in any combination of
such motion, depending only upon the profile of the peaks and
valleys (waveform) defined by the facing peripheral surfaces of the
collars 532a and 532b of FIG. 9B, as adapted to the work element of
FIGS. 5 and 7 above and as described herein. For example, the wave
form of elements 532a and 532b may include two shallow sinusoidal
waves followed by one deeper wave form around the circumferences of
the collar elements, and relative rotational motion of the proximal
and distal sheaths would thus produce two partial beak closures and
one full beak closure for one complete relative rotation between
the proximal and distal sheaths. As an example of relative
rotational speeds between the proximal and distal tubes, the
proximal tube may be rotated at 10,000 RPM while the distal tube
may be rotated at 9,940 RPM and thus lag the rotational speed of
the proximal tube or vice versa with a rotational speed of 10,040
RPM, according to embodiments. Such differential rotational speeds
may result in one full relative rotation of the distal and proximal
sheaths each second, or 60 times per minute, for example. Other
relative or absolute rotational speeds may be induced by the
driving assembly of the device 10, according to embodiments and
methods.
[0052] It is also important to note that in this embodiment related
to FIGS. 5 and 7, as well as for the embodiment previously
described in FIG. 9B above, that work element beak closure may also
be manually induced by simply pulling the distal sheath 320 axially
in a proximal direction in relation to the proximal sheath 300/302,
or pushing the proximal sheath 300/302 in a distal direction, which
may allow an operator to selectively close the beaks from the
handle 12 end of the device 10 in the absence of any relative
rotational motion and beak morcellation action induced between the
proximal and distal sheaths, or in concert with such motion.
Furthermore, in this embodiment as well as that described for FIG.
9B above, pushing the distal sheath 320 distally in axial motion
would therefore not actuate the beaks, as the distal sheath would
only push collars 532a and 532b axially together. As a result, any
periodic axial motion induced onto the distal sheath 320 would
result in the beaks of the work element, in any position (open
position, closed or partially closed) to move the entire work
element distally and proximally by a defined distance, according to
further embodiments and methods. Such axial motion of the distal
sheath therefore is independent of any induced axial motion of the
proximal sheath, and thus allows the driving mechanism to induce a
full range of motions of the work element, as desired by the
operator, including a simple coring under rotation, a jackhammer or
puncturing motion of the beaks with the beaks in any position, a
pulsed or periodic morcellation action of the beaks, partially or
fully closing and opening, or in any combination of those motions
with the additional option of being able to close the beaks
manually at any time. An embodiment of a simple driving mechanism
to enable such motions is described further herein in later
sections.
[0053] FIGS. 10A and 10B show features and elements of a single
monolithic tube 530 of a work element, which may comprise at its
distal terminus one or more fixed or articulable beaks, according
to various embodiments. In one embodiment, a work element is
comprised of a single tube 530, which may have a flexible portion
528 or portions disposed along its axial length. In FIG. 10B,
details of the distal end of a work element may be seen, with beak
tip(s) 524, tendon(s) 522, tendon actuation tab(s) 526, a collar
element 532 fixed to the tendon actuation tab(s) 526, and a
flexible tube portion 528, which may be coated to maintain liquids
within its central lumen while remaining flexible. As shown, a
proximally-directed force applied to collar 532 while maintaining
the body portion 530 fixed would tend to close the beak(s) or
scoopula(s) (cause them to flex towards the longitudinal axis of
the work element). The outer tube 330 of FIG. 8 above, which may
also be flexible along its length, with its shoulder 332 acting as
an internal stop barrier to the collar 532 of FIG. 10B, would allow
for pulsed axial motion of the beak tips, as induced by the driving
assembly of the handle 12 of device 10, but in such an embodiment,
such puncturing or jackhammer action would be accompanied by
partial or complete simultaneous closing down of the beak elements,
according to one embodiment.
[0054] FIG. 11 is a side perspective view of elements of a work
element, according to one embodiment. In this example, a tendon
actuation tab 469 is present, similar to the distal end of the work
element of FIG. 10A and similar to element 526 of FIG. 10B. The
distal beak or beaks or scoopula or scoopulas are not visible in
this illustration. In this illustration these structures are to the
left, off the page, whereas the proximal end of the device 10
(comprising the handle 12 and other ancillary structures are to the
right, off the page. In this embodiment, an inner tube and an outer
tube are coupled to the work element. Elements of the inner tube
comprise a tendon actuation tab 469, a tendon actuation tab welding
point 589, a body portion 428, body portion welding points 588 and
may also feature an extended flexible body portion 1b, which may be
either contiguous with body portion 468, or separated as shown in
the illustration, in which case it may take the form of an
Archimedes screw, according to embodiments. The flexible helical or
other shaped portion 582, may be coated according to one
embodiment. An outer tube 584 may also feature a flexible element
585, a spot weld or glue hole 587 which may be matched to weld
point 589 of an inner tube, and spot weld or glue holes 586 which
may be matched to weld points 588 of an inner tube of a work
element. An outer tube may also contain additional features for
flexibility along its axial length or cuts such as 584 to enable
vacuum or flush functions to be incorporated into a work elements
overall function. An outer tube may also have an outer coating,
according to one embodiment. Such an embodiment may also function
with a flexible or rigid outermost tube 330 of FIG. 8 above which
would enable beak actuation and pulsed puncturing motion of the
work assembly of the device 10, as described above for FIG. 10B,
but with the outer tube 584 distal end acting upon the shoulder
element 332 of such an outermost coaxial tube.
[0055] FIG. 12 shows a configuration of a flexible body portion 480
of a work element 13 tube, according to one embodiment. Flexible
elements 481 and 482 may be disposed along its length and it may
also be coated along part of all of its axial length, as indicated
in this illustration.
[0056] FIG. 13 is one configuration of a flexible body portion 490
of a work element 13 tube, according to one embodiment. Flexible
elements 492 may have one or more linking structures 493
incorporated, and may be formed of a single laser cut hypo-tube,
for example. There may be one or more such linking structures 493
for each turn of such a helix structure, which may also join
multiple helices such as found in FIG. 12 above, in which case each
link would alternately attach one helix to the other. Such linkages
may serve to stiffen axial compression characteristics of a tube
while still allowing lateral flexibility. Other helical structures
to allow a similar latitude of functions may be readily envisioned,
and are considered within the scope of this disclosure. A body
portion 490 of a work element tube may also be coated or uncoated
along part of all of its axial length, according to
embodiments.
[0057] FIGS. 14A and 14B illustrate elements and features of a
single tube work element, according to one embodiment. FIG. 14A
shows a single tube with a distal work element as a monolithic
structure and a proximal flexible extension 465 thereof. Reference
numeral 460 illustrates a line of sight through the central lumen
of the work element, which features one or more tip element(s) 453
(one of which may be fixed and non-articulable if two or more are
present), living hinge(s) 452 formed by kerfs in the work element,
tendon(s) 454, a tendon extension element 469 (as opposed to a
tendon actuation tab discussed under other embodiments herein) and
a body portion 458. Also illustrated is a collar 432, similar to
that collar 532 of previous illustrations, which may be a simple
collar or an outer tube serving the same purpose, as suggested by
the dashed lines extending proximally. The actions suggested by
arrows 462 and 464 represent the action of the work element with
differential axial forces acting on the tendon extension element
469 and body portion 458 of a work element, according to this
embodiment. If, for example, element 469 is held in place while a
distally-directed force 464 is applied to the body portion
extension 458, the distal tips of the work element will tend to
close and the reverse will be true if a proximally directed force
462 is applied to the work element. If an outer tube, such as that
illustrated in FIG. 8 above were to be placed over this single tube
work element, the collar 432 could be actuated by periodic or
sustained pressure against the internal shoulder 332 of the outer
tube, which actuation could result in a combined simultaneous
jackhammer-morcelation action of the beaks as they open and
close-moving slightly forward during closing.
[0058] FIG. 14B shows expanded details of portion 467 of FIG. 14A,
wherein the collar 532 (or rigid or flexible outer tube, according
to other embodiments) is fixed to the tendon extension element 469
by spot welding, for example. Note that in this embodiment, the
body portion extension tab element 458 is unconstrained and is free
to move axially in either direction within the limits of the
aperture from which it is formed in the work element. In this
embodiment, one or more dimples 701 may be welded onto the body
portion extension tab, and extend under the collar or tube 532,
thus pushing the tab slightly into the central lumen of the work
element, and allowing it to be abutted by and acted upon by a tube,
for instance, that may be placed into the central lumen to actuate
the work element tips by pushing against the proximal edge of the
body portion tab element 458 from within the work element.
[0059] FIG. 15 shows a single tube work element as a monolithic
structure, but differing from that of FIGS. 14A and 14B, according
to one embodiment. In this figure, it should be noted that the tip
452 or tips 452/454 (as shown, but a single tip would function
under the principles discussed herein, or an articulable tip acting
against a fixed opposite tip would also be fully functioning,
according to embodiments) are joined through tendon(s) 468/470 to a
tendon actuation tab 469 (as opposed to a body portion actuation
tab element 458 of FIG. 14B) and the tendon actuation tab 469 is
attached to a collar 532. A force such as force 462 of FIG. 14A
acting on the collar 532 would pull the tendon(s) 468/470 in a
proximal direction, forcing the living hinge shown at 458 in this
figure to flex and thus close the tip(s) against each other, or
flex the single tip into the central lumen, or close one
articulable tip against an opposite fixed tip, according to various
embodiments. As shown, the forces acting against the tip or tips in
this figure are similar to, but distinctly different from, in
application, the embodiment of FIG. 14A. In this case, the tendons
are pulled distally, pulling the tip(s) inward, whereas in FIG.
14A, the tendons are fixed and the body portion extension tab 458
is pushed distally to pull the tip(s) of that embodiment inward.
While the net result is that the tip(s) close as a result of
relative axial motion between portions of the single tube
structures in each embodiment, the two configurations may be
combined as discussed below to form a complex work element with a
simple activation mechanism, according to a further embodiment.
[0060] In further embodiments, a single scoopula of an outer device
of FIG. 14A, combined with an inner device of FIG. 15, may allow
for the inner beak, in the example cited, to nest into the outer
already flexed scoopula, which may be advantageous if the outer
scoopula work element is used as a downstream barrier while the
inner beak work element acts to remove or dislodge material
upstream from that point and from, for example, the lumen of an
artery. Such an embodiment may also be advantageous, as will be
illustrated later, to grasp both edges of an arterial obstruction
simultaneously while still allowing one or both work elements to
rotate independently of the other. A distal axial pushing of an
inner element, such as that shown in FIG. 15 against the end of the
tendon actuation element proximal to element 701 of the embodiment
of FIG. 14B, would result in both work elements closing and
morcellating, in a manner similar to the combined
jackhammer-morcellation action described above for FIGS. 14A and
14B with an outer tube of FIG. 8. According to one embodiment, a
third independent work element, which may comprise a coring
excisional device, may also be introduced down the central lumen of
the complex work element discussed in this paragraph. In such a
method, the complex work element, with its independent work
elements, could serve as a complete shield and isolate an inner
work area between the two work elements, while a third coring or
excisional work element is introduced to selectively retrieve
material in the central lumen of such an artificially-created work
area, thus protecting sensitive subjacent arterial wall structures
from the actions of the excisional work element. Any debris
dislodged by the coring or excisional process of the excisional
device may then be contained within the work area defined by the
complex work element described above, according to embodiments.
[0061] FIG. 16 shows details of a driving mechanism providing
various operating structure and functionalities to the work element
described above in FIGS. 9A and 9B, according to one embodiment.
This illustration is deliberately simplified for purposes of
discussing various modes of operation of a device 10. Illustrated
in this figure are the handle 12, a transfer magazine 27, the
tubular coring and transport assembly 11, an electric motor 41, a
combined inner/outer tube pinion 42 and drive belts, a manual beak
closure trigger 43 with its link, a jackhammer function pinion gear
44 with its drive belt, a jackhammer function sliding cam 45, an
outer tube driven gear 46, a synchronous inner tube pinion gear
portion 47, an asynchronous inner tube pinion gear portion 48, an
inner tube thrust bearing/plate assembly 49, an electric connection
50, and an outer tube thrust bearing/plate assembly 51. Using the
examples cited for previous figures above, it may be envisioned
that periodic pushing on the distal or outer tube 531, according to
embodiments, may produce a jackhammer motion induced, in this case,
by the jackhammer function sliding cam 45 being brought into close
proximity with and acting upon the outer tube thrust bearing/plate
assembly 51, either with the tubular coring and transport assembly
11 (inner and outer tubes) rotating or stationary. This function
may be manually selected by the operator at any time. If the drive
belt associated with the synchronous/asynchronous inner tube pinion
gear portions 47 and 48, respectively, is manually slid towards the
synchronous portion 47, the inner tube and outer tube will rotate
in synchronicity, and the beaks will remain in the position in
which they were found when that action is accomplished--either
open, closed, or partially open. If, however, the drive belt is
slid towards the asynchronous portion 48 of that pinion gear, the
inner tube will rotate in asynchronicity with the outer tube, and
the beaks will cycle open and closed, or partially opening and
closing with a morcellation action, as described in FIGS. 9A and 9B
above. This choice may therefore also be manually selected by the
operator to induce that desired action at any time. Similarly, if
the operator desires, at any time, to manually close the beaks,
that may be accomplished by pressing on the beak closure trigger
43, which in turn presses the link abutting the inner tube thrust
bearing/plate assembly 49. It should be noted, therefore, that
either differential rotational motion or pulling proximally on the
inner or proximal tube 528 (by action of the trigger 43 with its
link pushing it in a proximal direction), according to embodiments,
actuates the beaks to partially or fully open and close, including
a manual beak closing action, as may be desired by an operator.
Such an embodiment, as illustrated simply herein, enables full
functioning of the device 10 according to a multiplicity of desired
modes of operation, which may be selected at any time by an
operator to attack different segments of a chronic total occlusion,
for example, and according to methods. Although the embodiment
illustrated herein shows a mechanical system capable of inducing
the various desired movements to the work element, it is shown for
illustrative purposes only and one skilled in the art will
understand that any number of common driving elements and work
elements described herein may be combined to accomplish the same
purposes, all of which are considered to be within the scope of
this disclosure.
[0062] As may be inferred by the elements of the driving mechanism
of FIG. 16 above, the following exemplary selectable modes of
operation of a device 10 may be envisioned, according to various
methods and embodiments: [0063] Beaks open and coring under
rotation without morcellation; [0064] Beaks open and coring under
rotation without morcellation but with jackhammer puncturing
action; [0065] Beaks cyclically morcellating under rotation with
jackhammer puncturing action; [0066] Beaks cyclically morcellating
under rotation without jackhammer puncturing action; [0067] Beaks
closed and penetrating under rotation with jackhammer puncturing
action; [0068] Beaks closed and penetrating under rotation without
jackhammer puncturing action; [0069] Beaks closed and penetrating
with jackhammer puncturing action without rotation; [0070] Beaks
closed and penetrating without jackhammer puncturing action and
without rotation; [0071] Any of the above modes with or without
manual beak opening and closure, and/or with or without either or
both flush and vacuum at any time within a given operating mode.
Since the complete range of selectable options listed above is
available to an operator to pass through and capture the occluding
material, an operator is not limited to a single mode for an entire
procedure, according to methods herein. It may typically be found,
for example, that once a hard cap of an occlusion has been passed
that the occluding material may be softer and simple open beak
coring may be desired with an operator selected core length to
capture and transport occluding material out of the body, for
example and according to one method.
[0072] According to embodiments, one method of clearing a total
chronic occlusion may include advancing a guide wire to the face of
such an occlusion, the guide wire being furnished with a guidance
modality such as OCT, fiber optic camera element or ultra-sound
transponder, and even with a Geiger counter for certain soft tissue
biopsy requirements, for example. Once the guide wire is in place,
work element 13 may be advanced over the guide wire to the forward
face of the occlusion. The excisional work element of the device
may be used to attack the hard cap of the occlusion with high speed
cutting and coring under rotation or using any of the operating
modes described above, as selected by an operator. Alternatively,
work element 13 may be introduced within the structure of a
separate work element, for example containing scoopula or beak
structures to grip and anchor the sides of the occlusion's
typically hard cap, followed by a range of optional procedures. All
such procedures are now available due to the establishment of
access to the occlusion while protecting the subjacent arterial
wall structure. Once the hard occlusion cap has been penetrated and
removed, the device comprising work element 13 may be incrementally
advanced, with or without incremental scoopula closures in varying
degrees at various steps, which may be useful in incrementally
isolating portions of the occlusion to be removed and thus
preventing debris from flushing downstream and avoiding
complications due to embolic results caused by loose debris.
[0073] Represented in FIG. 17 is a rendition of a twin-beak device
(based on a double beak coring/part-off assembly in relationship
with a scoopula component) showing the two beaks in red in the
innermost position within a middle element (grey tubular/helical
element) a scoopula (brown, outermost element), and shown in distal
position where they are about to be closed to part-off tissue that
they have cored while rotating and traveling proximal to distal in
the scoopula, in their wide open configuration. The mechanism for
opening them and keeping them open throughout their proximal to
distal excursion involves rotating the grey outer sheath (outer
with respect to the inner red tube and/or helical element, inner
relative to the non or differentially rotating outer scoopula) in a
counter clockwise direction, together with and after holding back
the rotation of the inner element (red) only a matter of degrees
such that its helical element, which nests into similar helical
elements in the grey component, is driven back proximally, after
which the two tubular/helical elements (inner, red and middle,
brown) rotate together until closure is desired. In this example,
the living backbone element is of one structure with its helical
component ("threaded" section, nesting in a similar component in
the middle tubular/helical "threaded" section) and has limited
travel ability that comprises both rotation relative to the middle
tubular/helical structure and longitudinal (linear) movement.
Because the keystone element of the red beak component(s) is
constrained such that it may only move in a circular slot in the
middle (grey) tubular/helical structure, which is at a finer pitch
(shown here as 90 degrees to the long axis), the beaks necessarily
open wide based on the relative linear motions imposed on keystone
(attached to living tendons) and living backbone. Upon reaching the
part-off region, (or at any time part-off or other reason to close
the beak elements is desired) the inner-most tube/helix is made to
"catch up" while rotating, to the middle (grey) tubular/helical
element thus causing the threaded elements of each of the
tubular/helical components that are threaded with each other, to
return to the resting or "closed" configuration and force a linear
motion, again based on the fact that the keystone element is
constrained to only move at a finer pitch (in this case
approximately 90 degrees to the long axis of the roughly tubular
elements) than those of the threaded elements to fully close the
beaks.
[0074] FIG. 18 shows a single beak variant based on the same
principles as the above example shown with two beaks. In this
instance, the beak is already at a point where it is desirable to
have it close down against the inner surface of the scoopula for
purposes of parting-off a cored specimen or for penetration to
approach a target or for other purposes such as to deliver a
substance or element to a site without allowing ingress of tissue
during the approach to a target. In this case the rotating inner
(blue) tubular/helical structure will have been made to "catch up"
(briefly accelerated in rotation) with respect to the also rotating
middle tubular/helical structure (grey) closing the beak down
against the scoopula (tan) element. At that point rotation may be
completely halted for beak retraction and transport of cored
specimen(s) and the entire sequence repeated as often as
desired.
[0075] The described embodiments may be formed of or comprise one
or more biocompatible materials such as, for example, stainless
steel or other biocompatible alloys, and may be made of, comprise
or be coated with polymers and/or biopolymer materials as needed to
optimize function(s). For example, the cutting elements (such as
the constituent elements of a work element 13) may comprise or be
made of hardened alloys or carbon fiber or other polymers or
plastics, and may be additionally coated with a slippery material
or materials to thereby optimize passage through living tissues of
a variety of consistencies and frictions. Some of the components
may be purposely surface-treated differentially with respect to
adjacent components, as may be inferred herein in reference to a
transporting tubular and storage component (not shown). The various
internal or external components may be made of any suitable,
commercially available materials such as nylons, polymers such as
moldable plastics, and others. The handle may be configured in such
a way as to make it easily adaptable to one of any number of
existing guiding platforms, such as stereotactic table stages. The
materials used in the present material delivery or removal device
may also be carefully selected from a Ferro-magnetic standpoint,
such that the present material delivery or removal device maintains
compatibility with magnetic resonance imaging (MRI) equipment that
is commonly used for material delivery or removal procedures.
Vacuum/delivery assembly components may comprise commercially
available vacuum pumps, syringes and tubing for connecting to the
present material delivery or removal device, along with readily
available reed valves for switching between suction and emptying of
materials such as fluids which may be suctioned by vacuum
components. The fluids collected by the embodiments of the present
device in this manner may then be ejected into an additional
external, yet portable, liquid storage vessel connected to the
tubing of the present device, for safe keeping and laboratory
cellular analysis.
[0076] While certain embodiments of the disclosure have been
described, these embodiments have been presented by way of example
only, and are not intended to limit the scope of the disclosure.
Indeed, the novel methods, devices and systems described herein may
be embodied in a variety of other forms. Furthermore, various
omissions, substitutions and changes in the form of the methods and
systems described herein may be made without departing from the
spirit of the disclosure. The accompanying claims and their
equivalents are intended to cover such forms or modifications as
would fall within the scope and spirit of the disclosure. For
example, those skilled in the art will appreciate that in various
embodiments, the actual physical and logical structures may differ
from those shown in the figures. Depending on the embodiment,
certain steps described in the example above may be removed, and
others may be added. Also, the features and attributes of the
specific embodiments disclosed above may be combined in different
ways to form additional embodiments, all of which fall within the
scope of the present disclosure. Although the present disclosure
provides certain preferred embodiments and applications, other
embodiments that are apparent to those of ordinary skill in the
art, including embodiments which do not provide all of the features
and advantages set forth herein, are also within the scope of this
disclosure. Accordingly, the scope of the present disclosure is
intended to be defined only by reference to the appended
claims.
* * * * *