U.S. patent application number 13/388653 was filed with the patent office on 2012-07-26 for concentric cutting devices for use in minimally invasive medical procedures.
Invention is credited to Vacit Arat, Richard T. Chen, Gregory P. Schmitz, Arun Veeramani, Ming Ting Wu.
Application Number | 20120191121 13/388653 |
Document ID | / |
Family ID | 43607581 |
Filed Date | 2012-07-26 |
United States Patent
Application |
20120191121 |
Kind Code |
A1 |
Chen; Richard T. ; et
al. |
July 26, 2012 |
CONCENTRIC CUTTING DEVICES FOR USE IN MINIMALLY INVASIVE MEDICAL
PROCEDURES
Abstract
Various embodiments of a tissue cutting device are described,
such as a device with an elongate tube having a proximal end and a
distal end and a central axis extending from the proximal end to
the distal end; a first annular element at the distal end of the
elongate tube, the first annular element having a flat portion at
its distal end perpendicular to the central axis, the flat portion
extending from an outer circumference of the first annular element
to the central axis; and a second annular element at the distal end
of the elongate tube and concentric with the first annular element,
the second annular element having a flat portion at its distal end
perpendicular to the central axis, at least one of the first or
second annular elements rotatable about the central axis, the
rotation causing the first annular element and the second annular
element to pass each other to shear tissue.
Inventors: |
Chen; Richard T.; (Woodland
Hills, CA) ; Wu; Ming Ting; (Northridge, CA) ;
Veeramani; Arun; (Woodland Hills, CA) ; Arat;
Vacit; (La Canada Flintridge, CA) ; Schmitz; Gregory
P.; (Los Gatos, CA) |
Family ID: |
43607581 |
Appl. No.: |
13/388653 |
Filed: |
August 18, 2010 |
PCT Filed: |
August 18, 2010 |
PCT NO: |
PCT/US10/45951 |
371 Date: |
April 16, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61234989 |
Aug 18, 2009 |
|
|
|
Current U.S.
Class: |
606/180 |
Current CPC
Class: |
A61B 2017/320775
20130101; A61B 17/3203 20130101; A61B 17/32002 20130101; A61B
2017/00345 20130101; A61B 10/0266 20130101; A61B 2017/320064
20130101; A61B 17/320758 20130101; A61B 10/0283 20130101; A61B
2017/00526 20130101; A61B 17/3205 20130101 |
Class at
Publication: |
606/180 |
International
Class: |
A61B 17/32 20060101
A61B017/32 |
Claims
1. A tissue cutting device comprising: an elongate tube having a
proximal end and a distal end and a central axis extending from the
proximal end to the distal end; a first annular element at the
distal end of the elongate tube, the first annular element having a
flat portion at its distal end perpendicular to the central axis,
the flat portion extending from an outer circumference of the first
annular element to the central axis; and a second annular element
at the distal end of the elongate tube and concentric with the
first annular element, the second annular element having a flat
portion at its distal end perpendicular to the central axis, at
least one of the first or second annular elements rotatable about
the central axis, the rotation causing the first annular element
and the second annular element to pass each other to shear
tissue.
2. The tissue cutting device of claim 1 wherein the elongate tube
has a diameter less than 5 mm.
3. The tissue cutting device of claim 1 wherein at least one of the
first and second annular elements has a tooth having a radial
thickness of less than 50 microns.
4. The tissue cutting device of claim 1, wherein the flat portion
has an axial thickness of less than 100 microns.
5. The tissue cutting device of claim 1 wherein the first annular
element is rotatable about the central axis in an opposite
direction from the second annular element.
6. The tissue cutting device of claim 1 wherein the first annular
element is rotatable about the central axis in a same direction as
the second annular element, the first annular element and the
second annular element being configured to be rotated at different
speeds.
7. The tissue cutting device of claim 1, further comprising an
intake window at the distal end of the elongate tube.
8. The tissue cutting device of claim 1, further comprising a hole
extending along the central axis.
9. The tissue cutting device of claim 8, further comprising an
ancillary component extending through the hole, the ancillary
component comprising an imaging element, a guide wire, a water jet
tube, or a barbed device.
10. The tissue cutting device of claim 1, further comprising a
third annular element and a fourth annular element, the third and
fourth annular elements located between the proximal and distal
ends, at least one of the third or fourth annular elements
configured to rotate, the rotation causing the third and fourth
annular elements to rotate past each other to further shear the
tissue.
11. A tissue cutting device comprising: an elongate tube having a
proximal end and a distal end and a central axis extending from the
proximal end to the distal end; a first annular element at the
distal end of the elongate tube; a second annular element at the
distal end of the elongate tube and concentric with the first
annular element, at least one of the first or second annular
elements rotatable about the central axis, the rotation causing the
first annular element and the second annular element to pass each
other to shear tissue; wherein the first and second elements
together form a conical shape at the distal end of the elongate
tube; and wherein edges of the first and second tubular element are
beveled to further shear tissue.
12. The tissue cutting device of claim 11 wherein the elongate tube
has a diameter less than 5 mm.
13. The tissue cutting device of claim 11 wherein the beveled edges
have a thickness less than 10 microns.
14. The tissue cutting device of claim 11 wherein the first annular
element is rotatable about the central axis in an opposite
direction from the second annular element.
15. The tissue cutting device of claim 11 wherein the first and
second elements together form a second conical shape, the second
conical shape facing proximally.
16. The tissue cutting device of claim 11 wherein the first annular
element is rotatable about the central axis in a same direction as
the second annular element, the first annular element and the
second annular element being configured to rotate at different
speeds.
17. The tissue cutting device of claim 11, further comprising an
intake window at the distal end of the elongate tube.
18. The tissue cutting device of claim 11, further comprising a
hole extending along the central axis.
19. The tissue cutting device of claim 18, further comprising an
ancillary component extending through the hole, the ancillary
component comprising an imaging element, a guide wire, a water jet
tube, or a barbed device.
20. The tissue cutting device of claim 11, further comprising a
third annular element and a fourth annular element, the third and
fourth annular elements located between the proximal and distal
ends, at least one of the third or fourth annular elements
configured to rotate, the rotation causing the third and fourth
annular elements to rotate past each other to further shear the
tissue.
21. A tissue cutting device comprising: an elongate tube having a
proximal end and a distal end and a central axis extending from the
proximal end to the distal end; a first annular element at the
distal end of the elongate tube; a second annular element at the
distal end of the elongate tube and concentric with the first
annular element, at least one of the first or second annular
elements rotatable about the central axis; wherein the first and
second annular elements each have an axially-extending cutting
surface, the rotation causing the axially-extending surfaces of the
first and second annular elements to pass each other to shear
tissue, and wherein the first and second annular elements each have
a radially-extending cutting surface, rotation causing the
axially-extending surfaces of the first and second elements to pass
each other to shear tissue, wherein the axially extending cutting
surface has an axial length of less than 100 microns.
22. The tissue cutting device of claim 21 further comprising teeth
extending along the axially-extending or radially-extending cutting
surfaces.
23. The tissue cutting device of claim 21 wherein the elongate tube
has a diameter less than 0.5 mm.
24. The tissue cutting device of claim 21 wherein the first annular
element is rotatable about the central axis in an opposite
direction from the second annular element.
25. The tissue cutting device of claim 21 wherein the first annular
element is rotatable about the central axis in a same direction as
the second annular element, the first annular element and the
second annular element being configured to be rotated at different
speeds.
26. The tissue cutting device of claim 21, further comprising an
intake window at the distal end of the elongate tube.
27. The tissue cutting device of claim 21 further comprising a hole
extending along the central axis.
28. The tissue cutting device of claim 27, further comprising an
ancillary component extending through the hole, the ancillary
component comprising an imaging element, a guide wire, a water jet
tube, or a barbed device.
29. The tissue cutting device of claim 21, further comprising a
third annular element and a fourth annular element, the third and
fourth annular elements located between the proximal and distal
ends, at least one of the third or fourth annular elements
configured to rotate, the rotation causing the third and fourth
annular elements to rotate past each other to further shear the
tissue.
30. A tissue cutting device comprising: an elongate tube having a
proximal end and a distal end and a central axis extending from the
proximal end to the distal end; a first annular element at the
distal end of the elongate tube; a second annular element at the
distal end of the elongate tube and concentric with the first
annular element, at least one of the first or second annular
elements rotatable about the central axis; wherein the first and
second annular elements each include axially-extending teeth, the
teeth having a radial thickness of less than 10 microns, the
rotation causing the teeth of the first annular element and the
teeth of the second annular element to pass each other to shear
tissue.
31. The tissue cutting device of claim 30, wherein the elongate
tube has a diameter less than 5 mm.
32. The tissue cutting device of claim 30 wherein the first annular
element is rotatable about the central axis in an opposite
direction from the second annular element.
33. The tissue cutting device of claim 30 wherein the first annular
element is rotatable about the central axis in a same direction as
the second annular element, the first annular element and the
second annular element being configured to be rotated at different
speeds.
34. The tissue cutting device of claim 30 wherein the teeth have a
pitch of less than 200 microns.
35. The tissue cutting device of claim 30, further comprising an
intake window at the distal end of the elongate tube.
36. The tissue cutting device of claim 30, further comprising a
hole extending along the central axis.
37. The tissue cutting device of claim 36, further comprising an
ancillary component extending through the hole, the ancillary
component comprising an imaging element, a guide wire, a water jet
tube, or a barbed device.
38. The tissue cutting device of claim 30, further comprising a
third annular element and a fourth annular element, the third and
fourth annular elements located between the proximal and distal
ends, at least one of the third or fourth annular elements
configured to rotate, the rotation causing the third and fourth
annular elements to rotate past each other to further shear the
tissue.
39. A tissue cutting device, comprising: an elongate tube having a
proximal end and a distal end and a central axis extending from the
proximal end to the distal end; a first annular element at the
distal end of the elongate tube, the first annular element
including a plurality of first shearing elements, each first
shearing element having a perpendicular shearing surface that is
perpendicular to the central axis; a second annular element at the
distal end of the elongate tube and concentric with the first
annular element, the second annular element including a plurality
of second shearing elements, each second shearing element having a
perpendicular shearing surface that is perpendicular to the central
axis, wherein at least one of the first or second annular elements
is rotatable about the central axis, the rotation causing the
perpendicular shearing surfaces of the first shearing elements and
the perpendicular shearing surfaces of the second shearing elements
to pass each other to shear tissue.
40. The tissue cutting device of claim 39, wherein at least some of
the perpendicular shearing surfaces of the first shearing elements
lie along the same plane.
41. The tissue cutting device of claim 40, wherein the at least
some of the perpendicular shearing surfaces are located at the same
radial distance from the central axis.
42. The tissue cutting device of claim 39, wherein at least some of
the perpendicular shearing surfaces do not lie along the same
plane.
43. The tissue cutting device of claim 42, wherein the at least
some perpendicular shearing surfaces are located at different
radial distances from the central axis.
44. The tissue cutting device of claim 39, wherein each first
shearing element has a parallel shearing surface that is parallel
to the central axis; wherein each second shearing element has a
parallel shearing surface that is parallel to the central axis; and
wherein rotation of one or both of the first and second annular
element the causes the parallel shearing surfaces of the first
shearing elements and the parallel shearing surfaces of the second
shearing elements to pass each other to shear tissue.
45. The tissue cutting device of claim 44, wherein at least some of
the parallel shearing surfaces of the first shearing elements lie
along the same radial plane.
46. The tissue cutting device of claim 45, wherein the at least
some parallel shearing surfaces are spaced apart from each other
circumferentially.
47. The tissue cutting device of claim 44, wherein at least some of
the parallel shearing surfaces of the first shearing elements are
spaced apart from each other radially.
48. The tissue cutting device of claim 39, wherein the elongate
tube has a diameter of less than 5 mm.
49. A tissue cutting device, comprising: an elongate tube having a
proximal end and a distal end and a central axis extending from the
proximal end to the distal end; a first annular element at the
distal end of the elongate tube, the first annular element
including a plurality of first shearing elements, each first
shearing element having a parallel shearing surface that is
parallel to the central axis; a second annular element at the
distal end of the elongate tube and concentric with the first
annular element, the second annular element including a plurality
of second shearing element, each second shearing element having a
parallel shearing surface that is parallel to the central axis,
wherein at least one of the first or second annular elements is
rotatable about the central axis, the rotation causing the parallel
shearing surfaces of the first shearing elements and the parallel
shearing surfaces of the second shearing elements to pass each
other to shear tissue.
50. The tissue cutting device of claim 49, wherein at least some of
the parallel shearing surfaces of the first shearing elements lie
along the same radial plane.
51. The tissue cutting device of claim 50, wherein the at least
some of the parallel shearing surfaces are spaced apart from each
other axially.
52. The tissue cutting device of claim 51, wherein the at least
some of the parallel shearing surfaces are spaced apart from each
other circumferentially.
53. The tissue cutting device of claim 49, wherein at least some of
the parallel shearing surfaces of the first shearing elements are
spaced apart from each other radially.
54. The tissue cutting device of claim 49, wherein the elongate
tube has a diameter of less than 5 mm.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This Application claims priority to U.S. Application No.
61/234,989, filed Aug. 18, 2009, entitled "Concentric Cutting
Devices for use in Minimally Invasive Medical Procedures," which is
incorporated by reference as if fully set forth herein.
INCORPORATION BY REFERENCE
[0002] All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
FIELD OF INVENTION
[0003] Embodiments of the present invention relate to micro-scale
and millimeter-scale cutting devices that may be located at the
distal ends of, or at intermediate positions along the length of, a
lumen to provide material cutting, shredding, and removal. Such
devices may, for example, be used to remove unwanted tissue or
other material from selected locations within a body of a patient
during minimally invasive or other medical procedures. In some
embodiments, such devices may be used for non-medical procedure and
in some embodiments the devices may be made in whole or in part
using multi-layer, multi-material fabrication methods such as
electrochemical fabrication methods.
BACKGROUND OF THE INVENTION
Electrochemical Fabrication:
[0004] An electrochemical fabrication technique for forming
three-dimensional structures from a plurality of adhered layers is
being commercially pursued by Microfabrica.RTM.Inc. (formerly
MEMGen Corporation) of Van Nuys, Calif. under the name
EFAB.RTM..
[0005] Various electrochemical fabrication techniques were
described in U.S. Pat. No. 6,027,630, issued on Feb. 22, 2000 to
Adam Cohen. Some embodiments of this electrochemical fabrication
technique allows the selective deposition of a material using a
mask that includes a patterned conformable material on a support
structure that is independent of the substrate onto which plating
will occur. When desiring to perform an electrodeposition using the
mask, the conformable portion of the mask is brought into contact
with a substrate, but not adhered or bonded to the substrate, while
in the presence of a plating solution such that the contact of the
conformable portion of the mask to the substrate inhibits
deposition at selected locations. For convenience, these masks
might be generically called conformable contact masks; the masking
technique may be generically called a conformable contact mask
plating process. More specifically, in the terminology of
Microfabrica Inc. such masks have come to be known as INSTANT
MASKS.TM. and the process known as INSTANT MASKING or INSTANT
MASK.TM. plating. Selective depositions using conformable contact
mask plating may be used to form single selective deposits of
material or may be used in a process to form multi-layer
structures. The teachings of the '630 patent are hereby
incorporated herein by reference as if set forth in full herein.
Since the filing of the patent application that led to the above
noted patent, various papers about conformable contact mask plating
(i.e. INSTANT MASKING) and electrochemical fabrication have been
published: [0006] (1) A. Cohen, G. Zhang, F. Tseng, F. Mansfeld, U.
Frodis and P. Will, "EFAB: Batch production of functional,
fully-dense metal parts with micro-scale features", Proc. 9th Solid
Freeform Fabrication, The University of Texas at Austin, p 161,
August 1998. [0007] (2) A. Cohen, G. Zhang, F. Tseng, F. Mansfeld,
U. Frodis and P. Will, "EFAB: Rapid, Low-Cost Desktop
Micromachining of High Aspect Ratio True 3-D MEMS", Proc. 12th IEEE
Micro Electro Mechanical Systems Workshop, IEEE, p 244, January
1999. [0008] (3) A. Cohen, "3-D Micromachining by Electrochemical
Fabrication", Micromachine Devices, March 1999. [0009] (4) G.
Zhang, A. Cohen, U. Frodis, F. Tseng, F. Mansfeld, and P. Will,
"EFAB: Rapid Desktop Manufacturing of True 3-D Microstructures",
Proc. 2nd International Conference on Integrated
MicroNanotechnology for Space Applications, The Aerospace Co.,
April 1999. [0010] (5) F. Tseng, U. Frodis, G. Zhang, A. Cohen, F.
Mansfeld, and P. Will, "EFAB: High Aspect Ratio, Arbitrary 3-D
Metal Microstructures using a Low-Cost Automated Batch Process",
3rd International Workshop on High Aspect Ratio MicroStructure
Technology (HARMST'99), June 1999. [0011] (6) A. Cohen, U. Frodis,
F. Tseng, G. Zhang, F. Mansfeld, and P. Will, "EFAB: Low-Cost,
Automated Electrochemical Batch Fabrication of Arbitrary 3-D
Microstructures", Micromachining and Microfabrication Process
Technology, SPIE 1999 Symposium on Micromachining and
Microfabrication, September 1999. [0012] (7) F. Tseng, G. Zhang, U.
Frodis, A. Cohen, F. Mansfeld, and P. Will, "EFAB: High Aspect
Ratio, Arbitrary 3-D Metal Microstructures using a Low-Cost
Automated Batch Process", MEMS Symposium, ASME 1999 International
Mechanical Engineering Congress and Exposition, November, 1999.
[0013] (8) A. Cohen, "Electrochemical Fabrication (EFAB.TM.)",
Chapter 19 of The MEMS Handbook, edited by Mohamed Gad-El-Hak, CRC
Press, 2002. [0014] (9) Microfabrication--Rapid Prototyping's
Killer Application", pages 1-5 of the Rapid Prototyping Report,
CAD/CAM Publishing, Inc., June 1999.
[0015] The disclosures of these nine publications are hereby
incorporated herein by reference as if set forth in full
herein.
[0016] An electrochemical deposition for forming multilayer
structures may be carried out in a number of different ways as set
forth in the above patent and publications. In one form, this
process involves the execution of three separate operations during
the formation of each layer of the structure that is to be formed:
[0017] 1. Selectively depositing at least one material by
electrodeposition upon one or more desired regions of a substrate.
Typically this material is either a structural material or a
sacrificial material. [0018] 2. Then, blanket depositing at least
one additional material by electrodeposition so that the additional
deposit covers both the regions that were previously selectively
deposited onto, and the regions of the substrate that did not
receive any previously applied selective depositions. Typically
this material is the other of a structural material or a
sacrificial material. [0019] 3. Finally, planarizing the materials
deposited during the first and second operations to produce a
smoothed surface of a first layer of desired thickness having at
least one region containing the at least one material and at least
one region containing at least the one additional material.
[0020] After formation of the first layer, one or more additional
layers may be formed adjacent to an immediately preceding layer and
adhered to the smoothed surface of that preceding layer. These
additional layers are formed by repeating the first through third
operations one or more times wherein the formation of each
subsequent layer treats the previously formed layers and the
initial substrate as a new and thickening substrate.
[0021] Once the formation of all layers has been completed, at
least a portion of at least one of the materials deposited is
generally removed by an etching process to expose or release the
three-dimensional structure that was intended to be formed. The
removed material is a sacrificial material while the material that
forms part of the desired structure is a structural material.
[0022] The preferred method of performing the selective
electrodeposition involved in the first operation is by conformable
contact mask plating. In this type of plating, one or more
conformable contact (CC) masks are first formed. The CC masks
include a support structure onto which a patterned conformable
dielectric material is adhered or formed. The conformable material
for each mask is shaped in accordance with a particular
cross-section of material to be plated (the pattern of conformable
material is complementary to the pattern of material to be
deposited). At least one CC mask is used for each unique
cross-sectional pattern that is to be plated.
[0023] The support for a CC mask is typically a plate-like
structure formed of a metal that is to be selectively electroplated
and from which material to be plated will be dissolved. In this
typical approach, the support will act as an anode in an
electroplating process. In an alternative approach, the support may
instead be a porous or otherwise perforated material through which
deposition material will pass during an electroplating operation on
its way from a distal anode to a deposition surface. In either
approach, it is possible for multiple CC masks to share a common
support, i.e. the patterns of conformable dielectric material for
plating multiple layers of material may be located in different
areas of a single support structure. When a single support
structure contains multiple plating patterns, the entire structure
is referred to as the CC mask while the individual plating masks
may be referred to as "submasks". In the present application such a
distinction will be made only when relevant to a specific point
being made.
[0024] In preparation for performing the selective deposition of
the first operation, the conformable portion of the CC mask is
placed in registration with and pressed against a selected portion
of (1) the substrate, (2) a previously formed layer, or (3) a
previously deposited portion of a layer on which deposition is to
occur. The pressing together of the CC mask and relevant substrate
occur in such a way that all openings, in the conformable portions
of the CC mask contain plating solution. The conformable material
of the CC mask that contacts the substrate acts as a barrier to
electrodeposition while the openings in the CC mask that are filled
with electroplating solution act as pathways for transferring
material from an anode (e.g. the CC mask support) to the
non-contacted portions of the substrate (which act as a cathode
during the plating operation) when an appropriate potential and/or
current are supplied.
[0025] An example of a CC mask and CC mask plating are shown in
FIGS. 1A-1C. FIG. 1A shows a side view of a CC mask 8 consisting of
a conformable or deformable (e.g. elastomeric) insulator 10
patterned on an anode 12. The anode has two functions. One is as a
supporting material for the patterned insulator 10 to maintain its
integrity and alignment since the pattern may be topologically
complex (e.g., involving isolated "islands" of insulator material).
The other function is as an anode for the electroplating operation.
FIG. 1A also depicts a substrate 6, separated from mask 8, onto
which material will be deposited during the process of forming a
layer. CC mask plating selectively deposits material 22 onto
substrate 6 by simply pressing the insulator against the substrate
then electrodepositing material through apertures 26a and 26b in
the insulator as shown in FIG. 1B. After deposition, the CC mask is
separated, preferably non-destructively, from the substrate 6 as
shown in FIG. 1C.
[0026] The CC mask plating process is distinct from a
"through-mask" plating process in that in a through-mask plating
process the separation of the masking material from the substrate
would occur destructively. Furthermore in a through mask plating
process, opening in the masking material are typically formed while
the masking material is in contact with and adhered to the
substrate. As with through-mask plating, CC mask plating deposits
material selectively and simultaneously over the entire layer. The
plated region may consist of one or more isolated plating regions
where these isolated plating regions may belong to a single
structure that is being formed or may belong to multiple structures
that are being formed simultaneously. In CC mask plating as
individual masks are not intentionally destroyed in the removal
process, they may be usable in multiple plating operations.
[0027] Another example of a CC mask and CC mask plating is shown in
FIGS. 1D-1G. FIG. 1D shows an anode 12' separated from a mask 8'
that includes a patterned conformable material 10' and a support
structure 20. FIG. 1D also depicts substrate 6 separated from the
mask 8'. FIG. 1E illustrates the mask 8' being brought into contact
with the substrate 6. FIG. 1F illustrates the deposit 22' that
results from conducting a current from the anode 12' to the
substrate 6. FIG. 1G illustrates the deposit 22' on substrate 6
after separation from mask 8'. In this example, an appropriate
electrolyte is located between the substrate 6 and the anode 12'
and a current of ions coming from one or both of the solution and
the anode are conducted through the opening in the mask to the
substrate where material is deposited. This type of mask may be
referred to as an anodeless INSTANT MASK.TM. (AIM) or as an
anodeless conformable contact (ACC) mask.
[0028] Unlike through-mask plating, CC mask plating allows CC masks
to be formed completely separate from the substrate on which
plating is to occur (e.g. separate from a three-dimensional (3D)
structure that is being formed). CC masks may be formed in a
variety of ways, for example, using a photolithographic process.
All masks can be generated simultaneously, e.g. prior to structure
fabrication rather than during it. This separation makes possible a
simple, low-cost, automated, self-contained, and internally-clean
"desktop factory" that can be installed almost anywhere to
fabricate 3D structures, leaving any required clean room processes,
such as photolithography to be performed by service bureaus or the
like.
[0029] An example of the electrochemical fabrication process
discussed above is illustrated in FIGS. 2A-2F. These figures show
that the process involves deposition of a first material 2 which is
a sacrificial material and a second material 4 which is a
structural material. The CC mask 8, in this example, includes a
patterned conformable material (e.g. an elastomeric dielectric
material) 10 and a support 12 which is made from deposition
material 2. The conformal portion of the CC mask is pressed against
substrate 6 with a plating solution 14 located within the openings
16 in the conformable material 10. An electric current, from power
supply 18, is then passed through the plating solution 14 via (a)
support 12 which doubles as an anode and (b) substrate 6 which
doubles as a cathode. FIG. 2A illustrates that the passing of
current causes material 2 within the plating solution and material
2 from the anode 12 to be selectively transferred to and plated on
the substrate 6. After electroplating the first deposition material
2 onto the substrate 6 using CC mask 8, the CC mask 8 is removed as
shown in FIG. 2B. FIG. 2C depicts the second deposition material 4
as having been blanket-deposited (i.e. non-selectively deposited)
over the previously deposited first deposition material 2 as well
as over the other portions of the substrate 6. The blanket
deposition occurs by electroplating from an anode (not shown),
composed of the second material, through an appropriate plating
solution (not shown), and to the cathode/substrate 6. The entire
two-material layer is then planarized to achieve precise thickness
and flatness as shown in FIG. 2D. After repetition of this process
for all layers, the multi-layer structure 20 formed of the second
material 4 (i.e. structural material) is embedded in first material
2 (i.e. sacrificial material) as shown in FIG. 2E. The embedded
structure is etched to yield the desired device, i.e. structure 20,
as shown in FIG. 2F.
[0030] Various components of an exemplary manual electrochemical
fabrication system 32 are shown in FIGS. 3A-3C. The system 32
consists of several subsystems 34, 36, 38, and 40. The substrate
holding subsystem 34 is depicted in the upper portions of each of
FIGS. 3A-3C and includes several components: (1) a carrier 48, (2)
a metal substrate 6 onto which the layers are deposited, and (3) a
linear slide 42 capable of moving the substrate 6 up and down
relative to the carrier 48 in response to drive force from actuator
44. Subsystem 34 also includes an indicator 46 for measuring
differences in vertical position of the substrate which may be used
in setting or determining layer thicknesses and/or deposition
thicknesses. The subsystem 34 further includes feet 68 for carrier
48 which can be precisely mounted on subsystem 36.
[0031] The CC mask subsystem 36 shown in the lower portion of FIG.
3A includes several components: (1) a CC mask 8 that is actually
made up of a number of CC masks (i.e. submasks) that share a common
support/anode 12, (2) precision X-stage 54, (3) precision Y-stage
56, (4) frame 72 on which the feet 68 of subsystem 34 can mount,
and (5) a tank 58 for containing the electrolyte 16. Subsystems 34
and 36 also include appropriate electrical connections (not shown)
for connecting to an appropriate power source (not shown) for
driving the CC masking process.
[0032] The blanket deposition subsystem 38 is shown in the lower
portion of FIG. 3B and includes several components: (1) an anode
62, (2) an electrolyte tank 64 for holding plating solution 66, and
(3) frame 74 on which feet 68 of subsystem 34 may sit. Subsystem 38
also includes appropriate electrical connections (not shown) for
connecting the anode to an appropriate power supply (not shown) for
driving the blanket deposition process.
[0033] The planarization subsystem 40 is shown in the lower portion
of FIG. 3C and includes a lapping plate 52 and associated motion
and control systems (not shown) for planarizing the
depositions.
[0034] In addition to teaching the use of CC masks for
electrodeposition purposes, the '630 patent also teaches that the
CC masks may be placed against a substrate with the polarity of the
voltage reversed and material may thereby be selectively removed
from the substrate. It indicates that such removal processes can be
used to selectively etch, engrave, and polish a substrate, e.g., a
plaque.
[0035] The '630 patent further indicates that the electroplating
methods and articles disclosed therein allow fabrication of devices
from thin layers of materials such as, e.g., metals, polymers,
ceramics, and semiconductor materials. It further indicates that
although the electroplating embodiments described therein have been
described with respect to the use of two metals, a variety of
materials, e.g., polymers, ceramics and semiconductor materials,
and any number of metals can be deposited either by the
electroplating methods therein, or in separate processes that occur
throughout the electroplating method. It indicates that a thin
plating base can be deposited, e.g., by sputtering, over a deposit
that is insufficiently conductive (e.g., an insulating layer) so as
to enable subsequent electroplating. It also indicates that
multiple support materials (i.e. sacrificial materials) can be
included in the electroplated element allowing selective removal of
the support materials.
[0036] The '630 patent additionally teaches that the electroplating
methods disclosed therein can be used to manufacture elements
having complex microstructure and close tolerances between parts.
An example is given with the aid of FIGS. 14A-14E of that patent.
In the example, elements having parts that fit with close
tolerances, e.g., having gaps between about 1-5 um, including
electroplating the parts of the device in an unassembled,
preferably pre-aligned, state and once fabricated. In such
embodiments, the individual parts can be moved into operational
relation with each other or they can simply fall together. Once
together the separate parts may be retained by clips or the
like.
[0037] Another method for forming microstructures from
electroplated metals (i.e. using electrochemical fabrication
techniques) is taught in U.S. Pat. No. 5,190,637 to Henry Guckel,
entitled "Formation of Microstructures by Multiple Level Deep X-ray
Lithography with Sacrificial Metal layers". This patent teaches the
formation of metal structure utilizing through mask exposures. A
first layer of a primary metal is electroplated onto an exposed
plating base to fill a void in a photoresist (the photoresist
forming a through mask having a desired pattern of openings), the
photoresist is then removed and a secondary metal is electroplated
over the first layer and over the plating base. The exposed surface
of the secondary metal is then machined down to a height which
exposes the first metal to produce a flat uniform surface extending
across both the primary and secondary metals. Formation of a second
layer may then begin by applying a photoresist over the first layer
and patterning it (i.e. to form a second through mask) and then
repeating the process that was used to produce the first layer to
produce a second layer of desired configuration. The process is
repeated until the entire structure is formed and the secondary
metal is removed by etching. The photoresist is formed over the
plating base or previous layer by casting and patterning of the
photoresist (i.e. voids formed in the photoresist) are formed by
exposure of the photoresist through a patterned mask via X-rays or
UV radiation and development of the exposed or unexposed areas.
[0038] The '637 patent teaches the locating of a plating base onto
a substrate in preparation for electroplating materials onto the
substrate. The plating base is indicated as typically involving the
use of a sputtered film of an adhesive metal, such as chromium or
titanium, and then a sputtered film of the metal that is to be
plated. It is also taught that the plating base may be applied over
an initial layer of sacrificial material (i.e. a layer or coating
of a single material) on the substrate so that the structure and
substrate may be detached if desired. In such cases after formation
of the structure the sacrificial material forming part of each
layer of the structure may be removed along the initial sacrificial
layer to free the structure. Substrate materials mentioned in the
'637 patent include silicon, glass, metals, and silicon with
protected semiconductor devices. A specific example of a plating
base includes about 150 angstroms of titanium and about 300
angstroms of nickel, both of which are sputtered at a temperature
of 160.degree. C. In another example it is indicated that the
plating base may consist of 150 angstroms of titanium and 150
angstroms of nickel where both are applied by sputtering.
[0039] Electrochemical Fabrication provides the ability to form
prototypes and commercial quantities of miniature objects, parts,
structures, devices, and the like at reasonable costs and in
reasonable times. In fact, Electrochemical Fabrication is an
enabler for the formation of many structures that were hitherto
impossible to produce. Electrochemical Fabrication opens the
spectrum for new designs and products in many industrial fields.
Even though Electrochemical Fabrication offers this new capability
and it is understood that Electrochemical Fabrication techniques
can be combined with designs and structures known within various
fields to produce new structures, certain uses for Electrochemical
Fabrication provide designs, structures, capabilities and/or
features not known or obvious in view of the state of the art.
[0040] A need exists in various fields for miniature devices having
improved characteristics, reduced fabrication times, reduced
fabrication costs, simplified fabrication processes, greater
versatility in device design, improved selection of materials,
improved material properties, more cost effective and less risky
production of such devices, and/or more independence between
geometric configuration and the selected fabrication process.
Material Removal Devices for Medical Applications
[0041] Various mechanical material breakdown and/or removal methods
and devices have been proposed and/or used in minimally invasive
medical applications such as thrombectomy and atherectomy
procedures. These devices can be used in medical procedures
including planning, coring, milling, and drilling. Such devices,
for example, have included the use of cutting elements, shaving
elements, and grinding elements. Examples of cutting devices are
found, for example in (1) US Patent Application Publication No.
2006/0212060 A1, entitled "Arthroscopic Shaver and Method of
Manufacturing Same" by Randall L. Hacker, et al. and assigned to
Arthex, Inc.; (2) U.S. Pat. No. 6,447,525; (3) U.S. Pat. No.
7,479,147; and (4) U.S. Pat. No. 7,235,088.
[0042] Planing devices can be used to surface thin layers of
tissue, e.g. for removing scars from the surface of the skin.
Conventional planing devices include at least one sharp edge that
can be translated across the tissue to remove the top-most layer.
Such cutting surfaces in conventional planing devices generally
have dimensions that are too large to cut thin slices of tissue,
e.g. to cut slices of tissue having a thickness less than 50 .mu.m,
and these devices therefore cannot precisely remove small areas of
tissue.
[0043] Coring devices can be used for biopsying tissue.
Conventional coring devices generally include a needle that bores
into the tissue. Conventional coring devices tend to cause pulling
of and damage to surrounding tissue as the needle is pushed in. The
rapid forward movement of the needle can also push aside the target
tissue, such as a suspected tumor, especially if the target tissue
is firmer than the surrounding tissue. Further, conventional coring
devices do not have small enough feature sizes to remove only small
tissue particles, again resulting in excessive damage to
surrounding tissue.
[0044] Milling devices, such as debriders, can be used for
de-bulking, e.g. for surgical removal of a malignant tumor.
Conventional debriders include a rounded or pointed distal end to
aid in removing specific tissue. However, such conventional milling
devices are disadvantageous in that they often remove too much
tissue and, due to their rounded ends, cannot selectively remove
surface tissue. Further, conventional milling devices have
dimensions that are generally too large to precisely remove small
areas of tissue.
[0045] Drilling devices, such as atherectomy devices, are used to
cut through tissue in the body. For example, atherectomy devices
are used to treat atherosclerosis, in which the arteries are
obstructed due to the accumulation of plaque and neointimal
hyperplasia. Such atherectomy devices work by cutting away or
excising the obstructing plaque to help restore blood flow.
Drilling devices are configured in a variety of ways, but generally
include employing a rotatable and/or axially translatable cutting
blade or abrasive end which can be advanced into the occluding
material and rotated or translated to cut away the desired
material. Conventional drilling devices, however, have several
drawbacks. Namely, the minimum feature size and shape of such
devices, e.g. the size and shape of the cutting blades, are often
too large to cut specifically and precisely, such as down to a
micrometer or cellular scale. As a result, such devices tend to
either leave unwanted tissue in the body, such as plaque in the
blood vessel, or cut too much tissue, thereby injuring surrounding
tissue. Further, traditional drilling devices have a fairly large
diameter, e.g. over 2 mm, and are not configured to fit into small
lumens, such as blood vessels, having a smaller diameter. As a
result, some areas in the body are unreachable by conventional
drilling devices.
[0046] Accordingly, there is a need for small tissue-cutting
devices, such as planing, coring, milling, or drilling devices,
that can precisely cut tissue down to a micrometer or cellular
scale.
SUMMARY OF THE INVENTION
[0047] It is an object of some embodiments of the invention to
provide an improved method for forming multi-layer
three-dimensional structures
[0048] It is an object of some embodiments of the invention to
provide improved millimeter-scale or micro-scale devices that may
be used in minimally invasive procedure to provide therapeutic,
diagnostic, or preventive treatment.
[0049] Other objects and advantages of various embodiments of the
invention will be apparent to those of skill in the art upon review
of the teachings herein. The various embodiments of the invention,
set forth explicitly herein or otherwise ascertained from the
teachings herein, may address one or more of the above objects
alone or in combination, or alternatively may address some other
object ascertained from the teachings herein. It is not necessarily
intended that all objects be addressed by any single aspect of the
invention even though that may be the case with regard to some
aspects.
[0050] One aspect of the invention provides a tissue cutting device
with an elongate tube having a proximal end and a distal end and a
central axis extending from the proximal end to the distal end; a
first annular element at the distal end of the elongate tube, the
first annular element having a flat portion at its distal end
perpendicular to the central axis, the flat portion extending from
an outer circumference of the first annular element to the central
axis; and a second annular element at the distal end of the
elongate tube and concentric with the first annular element, the
second annular element having a flat portion at its distal end
perpendicular to the central axis, at least one of the first or
second annular elements rotatable about the central axis, the
rotation causing the first annular element and the second annular
element to pass each other to shear tissue. In various embodiments,
the elongate tube may have a diameter less than 5 mm, at least one
of the first and second annular elements may have a tooth having a
radial thickness of less than 50 microns, and/or the flat portion
may have an axial thickness of less than 100 microns. Some
embodiments of the invention have an intake window at the distal
end of the elongate tube.
[0051] In some embodiments, the first annular element is rotatable
about the central axis in an opposite direction from the second
annular element. In some embodiments, the first annular element is
rotatable about the central axis in a same direction as the second
annular element, and the first annular element and the second
annular element being configured to be rotated at different
speeds.
[0052] In some embodiments, the tissue cutting device includes a
hole extending along the central axis. In such embodiments, there
may also be an ancillary component extending through the hole, such
as an imaging element, a guide wire, a water jet tube, or a barbed
device.
[0053] Some embodiments also have a third annular element and a
fourth annular element, the third and fourth annular elements
located between the proximal and distal ends, at least one of the
third or fourth annular elements configured to rotate, the rotation
causing the third and fourth annular elements to rotate past each
other to further shear the tissue.
[0054] Another aspect of the invention provides a tissue cutting
device with an elongate tube having a proximal end and a distal end
and a central axis extending from the proximal end to the distal
end; a first annular element at the distal end of the elongate
tube; a second annular element at the distal end of the elongate
tube and concentric with the first annular element, at least one of
the first or second annular elements rotatable about the central
axis, the rotation causing the first annular element and the second
annular element to pass each other to shear tissue; wherein the
first and second elements together form a conical shape at the
distal end of the elongate tube; and wherein edges of the first and
second tubular element are beveled to further shear tissue. In
various embodiments the elongate tube may have a diameter less than
5 mm and the beveled edges may have a thickness less than 10
microns.
[0055] In some embodiments, the first annular element is rotatable
about the central axis in an opposite direction from the second
annular element. In some embodiments, the first and second elements
together form a second conical shape, the second conical shape
facing proximally. In some embodiments the first annular element is
rotatable about the central axis in a same direction as the second
annular element, the first annular element and the second annular
element being configured to be rotated at different speeds.
[0056] Some embodiments of the tissue cutting device may have an
intake window at the distal end of the elongate tube. Some
embodiments may have a hole extending along the central axis and,
optionally, an ancillary component extending through the hole, such
as an imaging element, a guide wire, a water jet tube, or a barbed
device.
[0057] In some embodiments, the tissue cutting device includes a
third annular element and a fourth annular element, the third and
fourth annular elements located between the proximal and distal
ends, at least one of the third or fourth annular elements
configured to rotate, the rotation causing the third and fourth
annular elements to rotate past each other to further shear the
tissue.
[0058] Yet another aspect of the invention provides a tissue
cutting device with an elongate tube having a proximal end and a
distal end and a central axis extending from the proximal end to
the distal end; a first annular element at the distal end of the
elongate tube; a second annular element at the distal end of the
elongate tube and concentric with the first annular element, at
least one of the first or second annular elements rotatable about
the central axis; wherein the first and second annular elements
each have an axially-extending cutting surface, the rotation
causing the axially-extending surfaces of the first and second
annular elements to pass each other to shear tissue, and wherein
the first and second annular elements each have a
radially-extending cutting surface, rotation causing the
axially-extending surfaces of the first and second elements to pass
each other to shear tissue, wherein the axially extending cutting
surface has an axial length of less than 100 microns.
[0059] In some embodiments, the tissue cutting device may have
teeth extending along the axially-extending or radially-extending
cutting surfaces. In various embodiments the elongate tube may have
a diameter less than 0.5 mm.
[0060] In some embodiments, the first annular element is rotatable
about the central axis in an opposite direction from the second
annular element. In some embodiments, the first annular element is
rotatable about the central axis in a same direction as the second
annular element, the first annular element and the second annular
element being configured to be rotated at different speeds.
[0061] Some embodiments of the tissue cutting device have an intake
window at the distal end of the elongate tube. Some embodiments of
the invention have a hole extending along the central axis and,
optionally, an ancillary component extending through the hole, such
as an imaging element, a guide wire, a water jet tube, or a barbed
device.
[0062] In some embodiments, the tissue cutting device includes a
third annular element and a fourth annular element, the third and
fourth annular elements located between the proximal and distal
ends, at least one of the third or fourth annular elements
configured to rotate, the rotation causing the third and fourth
annular elements to rotate past each other to further shear the
tissue.
[0063] Still another aspect of the invention provides a tissue
cutting device with an elongate tube having a proximal end and a
distal end and a central axis extending from the proximal end to
the distal end; a first annular element at the distal end of the
elongate tube; a second annular element at the distal end of the
elongate tube and concentric with the first annular element, at
least one of the first or second annular elements rotatable about
the central axis; wherein the first and second annular elements
each include axially-extending teeth, the teeth having a radial
thickness of less than 10 microns, the rotation causing the teeth
of the first annular element and the teeth of the second annular
element to pass each other to shear tissue. In some embodiments,
the elongate tube has a diameter less than 5 mm.
[0064] In some embodiments, the first annular element is rotatable
about the central axis in an opposite direction from the second
annular element. In some embodiments, the first annular element is
rotatable about the central axis in a same direction as the second
annular element, the first annular element and the second annular
element being configured to be rotated at different speeds.
[0065] In some embodiments of the tissue cutting device, the teeth
have a pitch of less than 200 microns. Some embodiments also
provide an intake window at the distal end of the elongate tube. In
some embodiments, the tissue cutting device includes a hole
extending along the central axis and, optionally, an ancillary
component extending through the hole, such as an imaging element, a
guide wire, a water jet tube, or a barbed device. In some
embodiments, the tissue cutting device includes a third annular
element and a fourth annular element, the third and fourth annular
elements located between the proximal and distal ends, at least one
of the third or fourth annular elements configured to rotate, the
rotation causing the third and fourth annular elements to rotate
past each other to further shear the tissue.
[0066] Another aspect of the invention provides a tissue cutting
device with an elongate tube having a proximal end and a distal end
and a central axis extending from the proximal end to the distal
end; a first annular element at the distal end of the elongate
tube, the first annular element including a plurality of first
shearing elements, each first shearing element having a
perpendicular shearing surface that is perpendicular to the central
axis; a second annular element at the distal end of the elongate
tube and concentric with the first annular element, the second
annular element including a plurality of second shearing elements,
each second shearing element having a perpendicular shearing
surface that is perpendicular to the central axis, wherein at least
one of the first or second annular elements is rotatable about the
central axis, the rotation causing the perpendicular shearing
surfaces of the first shearing elements and the perpendicular
shearing surfaces of the second shearing elements to pass each
other to shear tissue. In some embodiments, the elongate tube may
have a diameter of less than 5 mm.
[0067] In some embodiments, at least some of the perpendicular
shearing surfaces of the first shearing elements lie along the same
plane and, optionally, at least some of the perpendicular shearing
surfaces are located at the same radial distance from the central
axis.
[0068] In some embodiments, at least some of the perpendicular
shearing surfaces do not lie along the same plane and, optionally,
at least some perpendicular shearing surfaces are located at
different radial distances from the central axis.
[0069] In some embodiments, each first shearing element has a
parallel shearing surface that is parallel to the central axis;
wherein each second shearing element has a parallel shearing
surface that is parallel to the central axis; and wherein rotation
of the second annular element causes the causes the parallel
shearing surfaces of the first shearing elements and the parallel
shearing surfaces of the second shearing elements to pass each
other to shear tissue. In some such embodiments, at least some of
the parallel shearing surfaces of the first shearing elements lie
along the same radial plane and, optionally, the at least some
parallel shearing surfaces are spaced apart from each other
circumferentially. In some embodiments, at least some of the
parallel shearing surfaces of the first shearing elements are
spaced apart from each other radially.
[0070] Still another aspect of the invention provides a tissue
cutting device with an elongate tube having a proximal end and a
distal end and a central axis extending from the proximal end to
the distal end; a first annular element at the distal end of the
elongate tube, the first annular element including a plurality of
first shearing elements, each first shearing element having a
parallel shearing surface that is parallel to the central axis; a
second annular element at the distal end of the elongate tube and
concentric with the first annular element, the second annular
element including a plurality of second shearing element, each
second shearing element having a parallel shearing surface that is
parallel to the central axis, wherein at least one of the first or
second annular elements is rotatable about the central axis, the
rotation causing the parallel shearing surfaces of the first
shearing elements and the parallel shearing surfaces of the second
shearing elements to pass each other to shear tissue.
[0071] In some embodiments, at least some of the parallel shearing
surfaces of the first shearing elements lie along the same radial
plane. In some such embodiments, the at least some of the parallel
shearing surfaces are spaced apart from each other axially and,
optionally, the at least some of the parallel shearing surfaces are
spaced apart from each other circumferentially.
[0072] In some embodiments, at least some of the parallel shearing
surfaces of the first shearing elements are spaced apart from each
other radially. In some embodiments, the elongate tube may have a
diameter of less than 5 mm.
[0073] In another aspect, a cutting device includes an elongate
tube having a proximal end and a distal end, a first annular
element at the distal end of the elongate tube, and a second
annular element at the distal end of the elongate tube. The
elongate tube has a central axis extending from the proximal end to
the distal end. The first annular element includes at least one
surface, and the at least one surface has a first shearing element.
The second annular element includes at least one second surface,
and the at least one second surface includes a second shearing
element. The second annular element is concentric with the first
annular element and rotatable about a central axis. The rotation
causes the first shearing elements and the second shearing elements
to pass each other.
[0074] This and other embodiments may include one or more of the
following features. At least one surface can be perpendicular to
the central axis. At least one surface can be parallel to the
central axis. At least a portion of the at least one surface that
is perpendicular can be located at the radial-most location of the
first or second annular elements. The total radial length occupied
by the at least one perpendicular surface can be at least 1/10,
such as at least 1/5, such as at least 1/4, such as at least 1/3,
such as at least 1/2 of the radius of the cutting device. The at
least one surface can be spaced apart from the central axis. There
can be at least two surfaces occupy different planes which are
perpendicular to the central axis. There can be at least two
surfaces that are on a common plane and separated by a gap. The
distance between the first shearing element and the second shearing
element can be less than 20 microns, such as less than 10 microns,
such as less than 5 microns, such as approximately 1 micron. The
first and second shearing elements can be in contact when passing
each other. The shearing elements can be substantially parallel to
the central axis. The distance from the shearing element to the
central axis can be less than 7/8 of the radius, such as less than
3/4 of the radius, such as less than 5/8 of the radius, such as
less than 1/2 of the radius from the central axis. There can be
alternating shearing elements that are perpendicular and parallel
to the central axis, such as to form a stair-like profile. Each
surface can have a plurality of shearing elements.
[0075] In another aspect, a cutting device includes an elongate
tube having a proximal end and a distal end, a first annular
element at the distal end of the elongate tube, and a second
annular element at the distal end of the elongate tube. The
elongate tube has a central axis extending from the proximal end to
the distal end. The first annular element includes at least one
first blade element. The at least one first blade element can
include a first front surface and a first back surface, the first
front surface including a first front shearing element, and the
first back surface including a first back shearing element. The
second annular element includes at least one second blade element.
The at least one second blade element includes a second back
surface and a second front surface. The second front surface
includes a second front shearing element, and the second back
surface includes a second back shearing element.
[0076] This and other embodiments can include one or more of the
following features. The surfaces of the blades can be perpendicular
to the central axis. The surfaces of the blades can be
substantially parallel to the central axis. The first blade element
can include at least one second blade element perpendicular to the
first blade element. The distance between shearing elements of the
first annular element and shearing elements of the second shearing
elements can be less than 20 microns, such as less than 10 microns,
such as less than 5 microns, such as approximately 1 micron. The
shearing elements of the first annular element and the shearing
elements of the second annular elements can be in contact when
passing each other. The surfaces of the blades can have at least
one tooth.
[0077] The disclosure of the present invention provides numerous
device embodiments wherein the devices may be formed, in whole or
in part, using a multi-layer, multi-material fabrication process
wherein each successively formed layer comprises at least two
materials, one of which is a structural material and the other of
which is a sacrificial material, and wherein each successive layer
defines a successive cross-section of the three-dimensional
structure, and wherein the forming of each of the plurality of
successive layers includes: (i) depositing a first of the at least
two materials; (ii) depositing a second of the at least two
materials; and (B) after the forming of the plurality of successive
layers, separating at least a portion of the sacrificial material
from the structural material to reveal the three-dimensional
structure
[0078] Other aspects of the invention will be understood by those
of skill in the art upon review of the teachings herein. Other
aspects of the invention may involve combinations of the above
noted aspects of the invention. These other aspects of the
invention may provide various combinations of the aspects presented
above as well as provide other configurations, structures,
functional relationships, and processes that have not been
specifically set forth above.
BRIEF DESCRIPTION OF THE DRAWINGS
[0079] FIGS. 1A-1C schematically depict side views of various
stages of a CC mask plating process, while FIGS. 1D-G schematically
depict a side views of various stages of a CC mask plating process
using a different type of CC mask.
[0080] FIGS. 2A-2F schematically depict side views of various
stages of an electrochemical fabrication process as applied to the
formation of a particular structure where a sacrificial material is
selectively deposited while a structural material is blanket
deposited.
[0081] FIGS. 3A-3C schematically depict side views of various
example subassemblies that may be used in manually implementing the
electrochemical fabrication method depicted in FIGS. 2A-2F.
[0082] FIGS. 4A-4F schematically depict the formation of a first
layer of a structure using adhered mask plating where the blanket
deposition of a second material overlays both the openings between
deposition locations of a first material and the first material
itself
[0083] FIG. 4G depicts the completion of formation of the first
layer resulting from planarizing the deposited materials to a
desired level.
[0084] FIGS. 4H and 4I respectively depict the state of the process
after formation of the multiple layers of the structure and after
release of the structure from the sacrificial material.
[0085] FIGS. 5A-5E illustrate an exemplary embodiment of a cutting
device as described herein.
[0086] FIGS. 6A-6C illustrate an exemplary embodiment of a cutting
device as described herein.
[0087] FIGS. 7A-7B illustrate an exemplary embodiment of a cutting
device described herein.
[0088] FIG. 8 illustrates an exemplary embodiment of a cutting
described herein.
[0089] FIG. 9 illustrates an exemplary embodiment of a cutting
device described herein.
[0090] FIGS. 10A-10B illustrate an exemplary embodiment of a
cutting device described herein.
[0091] FIGS. 11A-11B illustrate an exemplary embodiment of a
cutting device described herein.
[0092] FIG. 12 illustrates an exemplary embodiment of a cutting
device described herein.
[0093] FIG. 13 illustrates an exemplary embodiment of a cutting
device described herein.
[0094] FIG. 14 illustrates an exemplary embodiment of a cutting
device described herein.
[0095] FIGS. 15A-15B illustrate an exemplary embodiment of a
cutting device described herein.
[0096] FIG. 16 illustrates an exemplary embodiment of a cutting
device described herein.
[0097] FIGS. 17A-17C illustrate an exemplary embodiment of a
cutting device described herein.
[0098] FIGS. 18 illustrates an exemplary embodiment of a cutting
device described herein.
[0099] FIG. 19 illustrates an exemplary embodiment of a cutting
device described herein.
[0100] FIGS. 20A-20H illustrate an exemplary embodiment of a
cutting device described herein.
[0101] FIG. 21 illustrates an exemplary embodiment of a cutting
device described herein.
[0102] FIGS. 22A-22B illustrate an exemplary embodiment of a
cutting device described herein.
[0103] FIGS. 23A-23B illustrate an exemplary embodiment of a
cutting device described herein.
[0104] FIGS. 24A-24B illustrate an exemplary embodiment of a
cutting device described herein.
[0105] FIGS. 25A-25C illustrate an exemplary embodiment of a
cutting device described herein.
[0106] FIGS. 26A-26C illustrate an exemplary embodiment of a
cutting device described herein.
[0107] FIGS. 27A-27C illustrate an exemplary embodiment of a
cutting device described herein.
[0108] FIGS. 28A-28B illustrate an exemplary embodiment of a
cutting device described herein.
[0109] FIG. 29 illustrates an exemplary embodiment of a tissue
cutting device having a working component extending
therethrough.
[0110] FIGS. 30A-30G illustrate exemplary embodiments of working
components that can extend through the medical devices described
herein.
DETAILED DESCRIPTION
Electrochemical Fabrication in General
[0111] FIGS. 1A-1G, 2A-2F, and 3A-3C illustrate various features of
one form of electrochemical fabrication. Other electrochemical
fabrication techniques are set forth in the '630 patent referenced
above, in the various previously incorporated publications, in
various other patents and patent applications incorporated herein
by reference. Still others may be derived from combinations of
various approaches described in these publications, patents, and
applications, or are otherwise known or ascertainable by those of
skill in the art from the teachings set forth herein. All of these
techniques may be combined with those of the various embodiments of
various aspects of the invention to yield enhanced embodiments.
Still other embodiments may be derived from combinations of the
various embodiments explicitly set forth herein.
[0112] FIGS. 4A-4I illustrate various stages in the formation of a
single layer of a multi-layer fabrication process where a second
metal is deposited on a first metal as well as in openings in the
first metal so that the first and second metal form part of the
layer. In FIG. 4A a side view of a substrate 82 is shown, onto
which patternable photoresist 84 is cast as shown in FIG. 4B. In
FIG. 4C, a pattern of resist is shown that results from the curing,
exposing, and developing of the resist. The patterning of the
photoresist 84 results in openings or apertures 92(a)-92(c)
extending from a surface 86 of the photoresist through the
thickness of the photoresist to surface 88 of the substrate 82. In
FIG. 4D a metal 94 (e.g. nickel) is shown as having been
electroplated into the openings 92(a)-92(c). In FIG. 4E the
photoresist has been removed (i.e. chemically stripped) from the
substrate to expose regions of the substrate 82 which are not
covered with the first metal 94. In FIG. 4F a second metal 96 (e.g.
silver) is shown as having been blanket electroplated over the
entire exposed portions of the substrate 82 (which is conductive)
and over the first metal 94 (which is also conductive). FIG. 4G
depicts the completed first layer of the structure which has
resulted from the planarization of the first and second metals down
to a height that exposes the first metal and sets a thickness for
the first layer. In FIG. 4H the result of repeating the process
steps shown in FIGS. 4B-4G several times to form a multi-layer
structure are shown where each layer consists of two materials. For
most applications, one of these materials is removed as shown in
FIG. 4I to yield a desired 3-D structure 98 (e.g. component or
device).
[0113] Various embodiments of various aspects of the invention are
directed to formation of three-dimensional structures from
materials some of which may be electrodeposited or electroless
deposited. Some of these structures may be formed form a single
build level formed from one or more deposited materials while
others are formed from a plurality of build layers each including
at least two materials (e.g. two or more layers, more preferably
five or more layers, and most preferably ten or more layers). In
some embodiments, layer thicknesses may be as small as one micron
or as large as fifty microns. In other embodiments, thinner layers
may be used while in other embodiments, thicker layers may be used.
In some embodiments structures having features positioned with
micron level precision and minimum features size on the order of
tens of microns are to be formed. In other embodiments structures
with less precise feature placement and/or larger minimum features
may be formed. In still other embodiments, higher precision and
smaller minimum feature sizes may be desirable. In the present
application meso-scale and millimeter scale have the same meaning
and refer to devices that may have one or more dimensions extending
into the 0.5-20 millimeter range, or somewhat larger and with
features positioned with precision in the 10-100 micron range and
with minimum features sizes on the order of 100 microns.
[0114] The various embodiments, alternatives, and techniques
disclosed herein may form multi-layer structures using a single
patterning technique on all layers or using different patterning
techniques on different layers. For example, Various embodiments of
the invention may perform selective patterning operations using
conformable contact masks and masking operations (i.e. operations
that use masks which are contacted to but not adhered to a
substrate), proximity masks and masking operations (i.e. operations
that use masks that at least partially selectively shield a
substrate by their proximity to the substrate even if contact is
not made), non-conformable masks and masking operations (i.e. masks
and operations based on masks whose contact surfaces are not
significantly conformable), and/or adhered masks and masking
operations (masks and operations that use masks that are adhered to
a substrate onto which selective deposition or etching is to occur
as opposed to only being contacted to it). Conformable contact
masks, proximity masks, and non-conformable contact masks share the
property that they are preformed and brought to, or in proximity
to, a surface which is to be treated (i.e. the exposed portions of
the surface are to be treated). These masks can generally be
removed without damaging the mask or the surface that received
treatment to which they were contacted, or located in proximity to.
Adhered masks are generally formed on the surface to be treated
(i.e. the portion of that surface that is to be masked) and bonded
to that surface such that they cannot be separated from that
surface without being completely destroyed damaged beyond any point
of reuse. Adhered masks may be formed in a number of ways including
(1) by application of a photoresist, selective exposure of the
photoresist, and then development of the photoresist, (2) selective
transfer of pre-patterned masking material, and/or (3) direct
formation of masks from computer controlled depositions of
material.
[0115] Patterning operations may be used in selectively depositing
material and/or may be used in the selective etching of material.
Selectively etched regions may be selectively filled in or filled
in via blanket deposition, or the like, with a different desired
material. In some embodiments, the layer-by-layer build up may
involve the simultaneous formation of portions of multiple layers.
In some embodiments, depositions made in association with some
layer levels may result in depositions to regions associated with
other layer levels (i.e. regions that lie within the top and bottom
boundary levels that define a different layer's geometric
configuration). Such use of selective etching and interlaced
material deposition in association with multiple layers is
described in U.S. Pat. No. 7,252,861, which is hereby incorporated
herein by reference as if set forth in full.
[0116] Temporary substrates on which structures may be formed may
be of the sacrificial-type (i.e. destroyed or damaged during
separation of deposited materials to the extent they cannot be
reused), non-sacrificial-type (i.e. not destroyed or excessively
damaged, i.e. not damaged to the extent they may not be reused,
e.g. with a sacrificial or release layer located between the
substrate and the initial layers of a structure that is formed).
Non-sacrificial substrates may be considered reusable, with little
or no rework (e.g. replanarizing one or more selected surfaces or
applying a release layer, and the like) though they may or may not
be reused for a variety of reasons.
DEFINITIONS
[0117] This section of the specification is intended to set forth
definitions for a number of specific terms that may be useful in
describing the subject matter of the various embodiments of the
invention. It is believed that the meanings of most if not all of
these terms is clear from their general use in the specification
but they are set forth hereinafter to remove any ambiguity that may
exist. It is intended that these definitions be used in
understanding the scope and limits of any claims that use these
specific terms. As far as interpretation of the claims of this
patent disclosure are concerned, it is intended that these
definitions take presence over any contradictory definitions or
allusions found in any materials which are incorporated herein by
reference.
[0118] "Build" as used herein refers, as a verb, to the process of
building a desired structure or plurality of structures from a
plurality of applied or deposited materials which are stacked and
adhered upon application or deposition or, as a noun, to the
physical structure or structures formed from such a process.
Depending on the context in which the term is used, such physical
structures may include a desired structure embedded within a
sacrificial material or may include only desired physical
structures which may be separated from one another or may require
dicing and/or slicing to cause separation.
[0119] "Build axis" or "build orientation" is the axis or
orientation that is substantially perpendicular to substantially
planar levels of deposited or applied materials that are used in
building up a structure. The planar levels of deposited or applied
materials may be or may not be completely planar but are
substantially so in that the overall extent of their
cross-sectional dimensions are significantly greater than the
height of any individual deposit or application of material (e.g.
100, 500, 1000, 5000, or more times greater). The planar nature of
the deposited or applied materials may come about from use of a
process that leads to planar deposits or it may result from a
planarization process (e.g. a process that includes mechanical
abrasion, e.g. lapping, fly cutting, grinding, or the like) that is
used to remove material regions of excess height. Unless explicitly
noted otherwise, "vertical" as used herein refers to the build axis
or nominal build axis (if the layers are not stacking with perfect
registration) while "horizontal" refers to a direction within the
plane of the layers (i.e. the plane that is substantially
perpendicular to the build axis).
[0120] "Build layer" or "layer of structure" as used herein does
not refer to a deposit of a specific material but instead refers to
a region of a build located between a lower boundary level and an
upper boundary level which generally defines a single cross-section
of a structure being formed or structures which are being formed in
parallel. Depending on the details of the actual process used to
form the structure, build layers are generally formed on and
adhered to previously formed build layers. In some processes the
boundaries between build layers are defined by planarization
operations which result in successive build layers being formed on
substantially planar upper surfaces of previously formed build
layers. In some embodiments, the substantially planar upper surface
of the preceding build layer may be textured to improve adhesion
between the layers. In other build processes, openings may exist in
or be formed in the upper surface of a previous but only partially
formed build layers such that the openings in the previous build
layers are filled with materials deposited in association with
current build layers which will cause interlacing of build layers
and material deposits. Such interlacing is described in U.S. patent
application Ser. No. 10/434,519 now U.S. Pat. No. 7,252,861. This
referenced application is incorporated herein by reference as if
set forth in full. In most embodiments, a build layer includes at
least one primary structural material and at least one primary
sacrificial material. However, in some embodiments, two or more
primary structural materials may be used without a primary
sacrificial material (e.g. when one primary structural material is
a dielectric and the other is a conductive material). In some
embodiments, build layers are distinguishable from each other by
the source of the data that is used to yield patterns of the
deposits, applications, and/or etchings of material that form the
respective build layers. For example, data descriptive of a
structure to be formed which is derived from data extracted from
different vertical levels of a data representation of the structure
define different build layers of the structure. The vertical
separation of successive pairs of such descriptive data may define
the thickness of build layers associated with the data. As used
herein, at times, "build layer" may be loosely referred simply as
"layer". In many embodiments, deposition thickness of primary
structural or sacrificial materials (i.e. the thickness of any
particular material after it is deposited) is generally greater
than the layer thickness and a net deposit thickness is set via one
or more planarization processes which may include, for example,
mechanical abrasion (e.g. lapping, fly cutting, polishing, and the
like) and/or chemical etching (e.g. using selective or
non-selective etchants). The lower boundary and upper boundary for
a build layer may be set and defined in different ways. From a
design point of view they may be set based on a desired vertical
resolution of the structure (which may vary with height). From a
data manipulation point of view, the vertical layer boundaries may
be defined as the vertical levels at which data descriptive of the
structure is processed or the layer thickness may be defined as the
height separating successive levels of cross-sectional data that
dictate how the structure will be formed. From a fabrication point
of view, depending on the exact fabrication process used, the upper
and lower layer boundaries may be defined in a variety of different
ways. For example by planarization levels or effective
planarization levels (e.g. lapping levels, fly cutting levels,
chemical mechanical polishing levels, mechanical polishing levels,
vertical positions of structural and/or sacrificial materials after
relatively uniform etch back following a mechanical or chemical
mechanical planarization process). For example, by levels at which
process steps or operations are repeated. At levels at which, at
least theoretically, lateral extends of structural material can be
changed to define new cross-sectional features of a structure.
[0121] "Layer thickness" is the height along the build axis between
a lower boundary of a build layer and an upper boundary of that
build layer.
[0122] "Planarization" is a process that tends to remove materials,
above a desired plane, in a substantially non-selective manner such
that all deposited materials are brought to a substantially common
height or desired level (e.g. within 20%, 10%, 5%, or even 1% of a
desired layer boundary level). For example, lapping removes
material in a substantially non-selective manner though some amount
of recession one material or another may occur (e.g. copper may
recess relative to nickel). Planarization may occur primarily via
mechanical means, e.g. lapping, grinding, fly cutting, milling,
sanding, abrasive polishing, frictionally induced melting, other
machining operations, or the like (i.e. mechanical planarization).
Mechanical planarization maybe followed or proceeded by thermally
induced planarization (.e.g. melting) or chemically induced
planarization (e.g. etching). Planarization may occur primarily via
a chemical and/or electrical means (e.g. chemical etching,
electrochemical etching, or the like). Planarization may occur via
a simultaneous combination of mechanical and chemical etching (e.g.
chemical mechanical polishing (CMP)).
[0123] "Structural material" as used herein refers to a material
that remains part of the structure when put into use.
[0124] "Supplemental structural material" as used herein refers to
a material that forms part of the structure when the structure is
put to use but is not added as part of the build layers but instead
is added to a plurality of layers simultaneously (e.g. via one or
more coating operations that applies the material, selectively or
in a blanket fashion, to a one or more surfaces of a desired build
structure that has been released from a sacrificial material.
[0125] "Primary structural material" as used herein is a structural
material that forms part of a given build layer and which is
typically deposited or applied during the formation of that build
layer and which makes up more than 20% of the structural material
volume of the given build layer. In some embodiments, the primary
structural material may be the same on each of a plurality of build
layers or it may be different on different build layers. In some
embodiments, a given primary structural material may be formed from
two or more materials by the alloying or diffusion of two or more
materials to form a single material.
[0126] "Secondary structural material" as used herein is a
structural material that forms part of a given build layer and is
typically deposited or applied during the formation of the given
build layer but is not a primary structural material as it
individually accounts for only a small volume of the structural
material associated with the given layer. A secondary structural
material will account for less than 20% of the volume of the
structural material associated with the given layer. In some
preferred embodiments, each secondary structural material may
account for less than 10%, 5%, or even 2% of the volume of the
structural material associated with the given layer. Examples of
secondary structural materials may include seed layer materials,
adhesion layer materials, barrier layer materials (e.g. diffusion
barrier material), and the like. These secondary structural
materials are typically applied to form coatings having thicknesses
less than 2 microns, 1 micron, 0.5 microns, or even 0.2 microns).
The coatings may be applied in a conformal or directional manner
(e.g. via CVD, PVD, electroless deposition, or the like). Such
coatings may be applied in a blanket manner or in a selective
manner. Such coatings may be applied in a planar manner (e.g. over
previously planarized layers of material) as taught in U.S. patent
application Ser. No. 10/607,931, now U.S. Pat. No. 7,239,219. In
other embodiments, such coatings may be applied in a non-planar
manner, for example, in openings in and over a patterned masking
material that has been applied to previously planarized layers of
material as taught in U.S. patent application Ser. No. 10/841,383,
now U.S. Pat. No. 7,195,989. These referenced applications are
incorporated herein by reference as if set forth in full
herein.
[0127] "Functional structural material" as used herein is a
structural material that would have been removed as a sacrificial
material but for its actual or effective encapsulation by other
structural materials. Effective encapsulation refers, for example,
to the inability of an etchant to attack the functional structural
material due to inaccessibility that results from a very small area
of exposure and/or due to an elongated or tortuous exposure path.
For example, large (10,000 .mu.m.sup.2) but thin (e.g. less than
0.5 microns) regions of sacrificial copper sandwiched between
deposits of nickel may define regions of functional structural
material depending on ability of a release etchant to remove the
sandwiched copper.
[0128] "Sacrificial material" is material that forms part of a
build layer but is not a structural material. Sacrificial material
on a given build layer is separated from structural material on
that build layer after formation of that build layer is completed
and more generally is removed from a plurality of layers after
completion of the formation of the plurality of layers during a
"release" process that removes the bulk of the sacrificial material
or materials. In general sacrificial material is located on a build
layer during the formation of one, two, or more subsequent build
layers and is thereafter removed in a manner that does not lead to
a planarized surface. Materials that are applied primarily for
masking purposes, i.e. to allow subsequent selective deposition or
etching of a material, e.g. photoresist that is used in forming a
build layer but does not form part of the build layer) or that
exist as part of a build for less than one or two complete build
layer formation cycles are not considered sacrificial materials as
the term is used herein but instead shall be referred as masking
materials or as temporary materials. These separation processes are
sometimes referred to as a release process and may or may not
involve the separation of structural material from a build
substrate. In many embodiments, sacrificial material within a given
build layer is not removed until all build layers making up the
three-dimensional structure have been formed. Of course sacrificial
material may be, and typically is, removed from above the upper
level of a current build layer during planarization operations
during the formation of the current build layer. Sacrificial
material is typically removed via a chemical etching operation but
in some embodiments may be removed via a melting operation or
electrochemical etching operation. In typical structures, the
removal of the sacrificial material (i.e. release of the structural
material from the sacrificial material) does not result in
planarized surfaces but instead results in surfaces that are
dictated by the boundaries of structural materials located on each
build layer. Sacrificial materials are typically distinct from
structural materials by having different properties therefrom (e.g.
chemical etchability, hardness, melting point, etc.) but in some
cases, as noted previously, what would have been a sacrificial
material may become a structural material by its actual or
effective encapsulation by other structural materials. Similarly,
structural materials may be used to form sacrificial structures
that are separated from a desired structure during a release
process via the sacrificial structures being only attached to
sacrificial material or potentially by dissolution of the
sacrificial structures themselves using a process that is
insufficient to reach structural material that is intended to form
part of a desired structure. It should be understood that in some
embodiments, small amounts of structural material may be removed,
after or during release of sacrificial material. Such small amounts
of structural material may have been inadvertently formed due to
imperfections in the fabrication process or may result from the
proper application of the process but may result in features that
are less than optimal (e.g. layers with stairs steps in regions
where smooth sloped surfaces are desired. In such cases the volume
of structural material removed is typically minuscule compared to
the amount that is retained and thus such removal is ignored when
labeling materials as sacrificial or structural. Sacrificial
materials are typically removed by a dissolution process, or the
like, that destroys the geometric configuration of the sacrificial
material as it existed on the build layers. In many embodiments,
the sacrificial material is a conductive material such as a metal.
As will be discussed hereafter, masking materials though typically
sacrificial in nature are not termed sacrificial materials herein
unless they meet the required definition of sacrificial
material.
[0129] "Supplemental sacrificial material" as used herein refers to
a material that does not form part of the structure when the
structure is put to use and is not added as part of the build
layers but instead is added to a plurality of layers simultaneously
(e.g. via one or more coating operations that applies the material,
selectively or in a blanket fashion, to a one or more surfaces of a
desired build structure that has been released from an initial
sacrificial material. This supplemental sacrificial material will
remain in place for a period of time and/or during the performance
of certain post layer formation operations, e.g. to protect the
structure that was released from a primary sacrificial material,
but will be removed prior to putting the structure to use.
[0130] "Primary sacrificial material" as used herein is a
sacrificial material that is located on a given build layer and
which is typically deposited or applied during the formation of
that build layer and which makes up more than 20% of the
sacrificial material volume of the given build layer. In some
embodiments, the primary sacrificial material may be the same on
each of a plurality of build layers or may be different on
different build layers. In some embodiments, a given primary
sacrificial material may be formed from two or more materials by
the alloying or diffusion of two or more materials to form a single
material.
[0131] "Secondary sacrificial material" as used herein is a
sacrificial material that is located on a given build layer and is
typically deposited or applied during the formation of the build
layer but is not a primary sacrificial materials as it individually
accounts for only a small volume of the sacrificial material
associated with the given layer. A secondary sacrificial material
will account for less than 20% of the volume of the sacrificial
material associated with the given layer. In some preferred
embodiments, each secondary sacrificial material may account for
less than 10%, 5%, or even 2% of the volume of the sacrificial
material associated with the given layer. Examples of secondary
structural materials may include seed layer materials, adhesion
layer materials, barrier layer materials (e.g. diffusion barrier
material), and the like. These secondary sacrificial materials are
typically applied to form coatings having thicknesses less than 2
microns, 1 micron, 0.5 microns, or even 0.2 microns). The coatings
may be applied in a conformal or directional manner (e.g. via CVD,
PVD, electroless deposition, or the like). Such coatings may be
applied in a blanket manner or in a selective manner. Such coatings
may be applied in a planar manner (e.g. over previously planarized
layers of material) as taught in U.S. patent application Ser. No.
10/607,931, now U.S. Pat. No. 7,239,219. In other embodiments, such
coatings may be applied in a non-planar manner, for example, in
openings in and over a patterned masking material that has been
applied to previously planarized layers of material as taught in
U.S. patent application Ser. No. 10/841,383, now U.S. Pat. No.
7,195,989. These referenced applications are incorporated herein by
reference as if set forth in full herein.
[0132] "Adhesion layer", "seed layer", "barrier layer", and the
like refer to coatings of material that are thin in comparison to
the layer thickness and thus generally form secondary structural
material portions or sacrificial material portions of some layers.
Such coatings may be applied uniformly over a previously formed
build layer, they may be applied over a portion of a previously
formed build layer and over patterned structural or sacrificial
material existing on a current (i.e. partially formed) build layer
so that a non-planar seed layer results, or they may be selectively
applied to only certain locations on a previously formed build
layer. In the event such coatings are non-selectively applied,
selected portions may be removed (1) prior to depositing either a
sacrificial material or structural material as part of a current
layer or (2) prior to beginning formation of the next layer or they
may remain in place through the layer build up process and then
etched away after formation of a plurality of build layers.
[0133] "Masking material" is a material that may be used as a tool
in the process of forming a build layer but does not form part of
that build layer. Masking material is typically a photopolymer or
photoresist material or other material that may be readily
patterned. Masking material is typically a dielectric. Masking
material, though typically sacrificial in nature, is not a
sacrificial material as the term is used herein. Masking material
is typically applied to a surface during the formation of a build
layer for the purpose of allowing selective deposition, etching, or
other treatment and is removed either during the process of forming
that build layer or immediately after the formation of that build
layer.
[0134] "Multilayer structures" are structures formed from multiple
build layers of deposited or applied materials.
[0135] "Multilayer three-dimensional (or 3D or 3-D) structures" are
Multilayer Structures that meet at least one of two criteria: (1)
the structural material portion of at least two layers of which one
has structural material portions that do not overlap structural
material portions of the other.
[0136] "Complex multilayer three-dimensional (or 3D or 3-D)
structures" are multilayer three-dimensional structures formed from
at least three layers where a line may be defined that
hypothetically extends vertically through at least some portion of
the build layers of the structure will extend from structural
material through sacrificial material and back through structural
material or will extend from sacrificial material through
structural material and back through sacrificial material (these
might be termed vertically complex multilayer three-dimensional
structures). Alternatively, complex multilayer three-dimensional
structures may be defined as multilayer three-dimensional
structures formed from at least two layers where a line may be
defined that hypothetically extends horizontally through at least
some portion of a build layer of the structure that will extend
from structural material through sacrificial material and back
through structural material or will extend from sacrificial
material through structural material and back through sacrificial
material (these might be termed horizontally complex multilayer
three-dimensional structures). Worded another way, in complex
multilayer three-dimensional structures, a vertically or
horizontally extending hypothetical line will extend from one or
structural material or void (when the sacrificial material is
removed) to the other of void or structural material and then back
to structural material or void as the line is traversed along at
least a portion of the line.
[0137] "Moderately complex multilayer three-dimensional (or 3D or
3-D) structures" are complex multilayer 3D structures for which the
alternating of void and structure or structure and void not only
exists along one of a vertically or horizontally extending line but
along lines extending both vertically and horizontally.
[0138] "Highly complex multilayer (or 3D or 3-D) structures" are
complex multilayer 3D structures for which the
structure-to-void-to-structure or void-to-structure-to-void
alternating occurs once along the line but occurs a plurality of
times along a definable horizontally or vertically extending
line.
[0139] "Up-facing feature" is an element dictated by the
cross-sectional data for a given build layer "n" and a next build
layer "n+1" that is to be formed from a given material that exists
on the build layer "n" but does not exist on the immediately
succeeding build layer "n+1". For convenience the term "up-facing
feature" will apply to such features regardless of the build
orientation.
[0140] "Down-facing feature" is an element dictated by the
cross-sectional data for a given build layer "n" and a preceding
build layer "n-1" that is to be formed from a given material that
exists on build layer "n" but does not exist on the immediately
preceding build layer "n-1". As with up-facing features, the term
"down-facing feature" shall apply to such features regardless of
the actual build orientation.
[0141] "Continuing region" is the portion of a given build layer
"n" that is dictated by the cross-sectional data for the given
build layer "n", a next build layer "n+1" and a preceding build
layer "n-1" that is neither up-facing nor down-facing for the build
layer "n".
[0142] "Minimum feature size" refers to a necessary or desirable
spacing between structural material elements on a given layer that
are to remain distinct in the final device configuration. If the
minimum feature size is not maintained on a given layer, the
fabrication process may result in structural material inadvertently
bridging the two structural elements due to masking material
failure or failure to appropriately fill voids with sacrificial
material during formation of the given layer such that during
formation of a subsequent layer structural material inadvertently
fills the void. More care during fabrication can lead to a
reduction in minimum feature size or a willingness to accept
greater losses in productivity can result in a decrease in the
minimum feature size. However, during fabrication for a given set
of process parameters, inspection diligence, and yield (successful
level of production) a minimum design feature size is set in one
way or another. The above described minimum feature size may more
appropriately be termed minimum feature size of sacrificial
material regions. Conversely a minimum feature size for structure
material regions (minimum width or length of structural material
elements) may be specified. Depending on the fabrication method and
order of deposition of structural material and sacrificial
material, the two types of minimum feature sizes may be different.
In practice, for example, using electrochemical fabrication methods
and described herein, the minimum features size on a given layer
may be roughly set to a value that approximates the layer thickness
used to form the layer and it may be considered the same for both
structural and sacrificial material widths and lengths. In some
more rigorously implemented processes, examination regiments, and
rework requirements, it may be set to an amount that is 80%, 50%,
or even 30% of the layer thickness. Other values or methods of
setting minimum feature sizes may be set.
[0143] "Sublayer" as may be used herein refers to a portion of a
build layer that typically includes the full lateral extents of
that build layer but only a portion of its height. A sublayer is
usually a vertical portion of build layer that undergoes
independent processing compared to another sublayer of that build
layer.
Cylindrical Cutting Devices
[0144] Various cylindrical cutting devices or instrument
embodiments will be discussed below. These devices may be used in a
number of different tissue removal methods, such as planing,
coring, milling, or drilling. Such tissue removal methods can be
used in various applications including: (1) Disc, other tissue, or
bone in the spinal region, for example, to relieve pressure on
spinal nerves, (2) Ear, nose (sinus), and throat surgery, (3)
ophthalmic procedures such as cataract surgery; (4) Cardiovascular
(can be delivered over a guide wire) surgery or procedures such as
(a) Blood clot removal (Thrombectomy); (b) Chronic total occlusion
(CTO); (c) Atherectomy; (d) Removal of heart tissue; (5)
Neurovascular procedures such as thrombectomy; (6) Breast surgeries
or procedures such as (a) Breast duct papilloma, and (b)
Lumpectomy; (7) Orthopedic surgeries and procedures such as (a)
Joint surgeries; (b) Removal of bone spurs; and (c) Arthroscopic
surgeries; (8) Peripheral artery disease surgeries and procedures;
(9) other thrombectomy and atherectomy procedures and (10) Removal
of tumors, cancerous tissue, and other excess tissue masses. The
devices of various embodiments of the invention may also be used in
non-medical applications.
[0145] The cutting devices described herein can advantageously be
constructed using the electrochemical fabrication process. Using
the electrochemical fabrication process allows the devices to be on
the micrometer or nanometer scale and have precision on the order
of tens of microns. Medical devices having such scale and precision
are advantageous over conventional medical devices because they can
be sharper, have more cutting surfaces, and be more intricately
shaped. As a result, the medical devices described herein can be
used for selective and accurate removal of tissue or other material
within the body.
[0146] Further, using the electrochemical fabrication process is
advantageous because the scale and precision available by doing so
allows the medical devices to be configured to be used in
conjunction with additional therapeutic or diagnostic elements. For
example, the medical devices described herein may be used in
conjunction with ancillary components extending through the center
of the device, such as guide wires, endoscopes or other imaging
methods (IVUS, OCT, OFDI, etc), aspiration, irrigation, and other
micro-scale or millimeter-scale devices and instruments such as
distal protection devices (see U.S. patent application Ser. No.
12/179,573), positioning instruments such as expanders (see U.S.
patent application Ser. No. 12/179,573), other tissue shredding
devices such as those described in U.S. patent application Ser. No.
12/490,301, and guiding and configurable elements such as those
described in U.S. patent application Ser. Nos. 12/169,528;
12/179,295; and 12/144,618.
[0147] Although the medical devices described herein can be
produced using the electrochemical fabrication process, additional
fabrication processes may also be used.
[0148] The cutting devices described herein can each include two
concentric components, which can be configured to rotate relative
to one another to perform the desired surgical function. As such,
only one concentric component can be rotated, both can be rotated
in opposite directions, or both can be rotated in the same
direction, but at different rates. The dimensions of the various
cutting devices can be adjusted to obtain a desired degree of
tissue removal.
[0149] FIGS. 5A-5E illustrate a cutting device 100. The first
component 101 of the device 100 includes an inner cutting element
102, having a primary cutting surface 103 and a secondary cutting
surface 104. The second component 111 likewise includes an outer
cutting element 112, having a primary surface 113 and a secondary
surface 114. When assembled as shown in FIG. 5E, the first
component 101 is capable of rotating relative to the second
component 111, and the interaction of the cutting surfaces can
cause shearing away of layers of tissue or other material as the
inner and outer cutting elements rotate past one another. In some
embodiments, either or both components can be configured to rotate
in either direction. For example, the first component can rotate
counter-clockwise, and the second component can rotate
clockwise.
[0150] Both the inner and outer cutters 102, 112 can have
singled-sided substantially radially-extending primary cutting
surfaces 103 and 113 as well as secondary cutting surfaces 104 and
114 extending substantially axially at the radial extremes of the
components. Having a primary cutting surface extending
substantially radially and a secondary cutting surface extending
substantially axially can be advantageous over prior art cutting
devices because it provides more cutting surfaces for shearing off
tissue. Further, the axial length of the secondary cutting surfaces
104 and 114 can be less than 100 microns, such as less than 50
microns, such as less than 10 microns. Such a small axial length
allows for accurate removal of small layers of tissue, such as
layers between 2 and 5 microns thick. Thus, for example, cutting
device 100 can be used for planing of thin slices of tissue.
[0151] Teeth 105 and 115 can extend along the primary and/or the
secondary cutting surfaces. The teeth 105 and 115 can all be
configured such that they extend radially. The teeth 105 and 115
can be configured to, upon rotation of the first and second
components 101, 111, engage one another substantially
point-to-point, relative to a centered longitudinal axis 121 of
relative rotation of the elements. The teeth 105 and 115 can aid in
shearing off layers of tissue during the planing process.
[0152] As shown in the figures, the cutting surface of the first
component 101 is supported by a sloped surface that sweeps a
three-dimensional curve (i.e. sweeping in radial, axial or
longitudinal, and azimuthal directions). The proximal facing
portion of this sloped surface, when rotating in a counterclockwise
direction, may aid in pushing sheared off material in a proximal
and longitudinal direction to help remove material and ensure that
the cutting surface of the blade is cleared of material and ready
to shear off newly encountered material.
[0153] As shown, the first component 101 of device 100 includes an
intake window 122. The intake window 122 can, for example, extend
across at least one-half of the distal end of the cutting device,
such as approximately one-half of the distal end of the cutting
device. The intake window 122 permits tissue to extend into the
interior of cutting device 100 to enable the interacting cutting
surfaces of the first and second components to shear the tissue,
for example during a planing process.
[0154] As shown in the figures the components may be formed with a
plurality of etching or release holes so that the individual
components may be formed using a multi-material, multi-layer
fabrication method and then the sacrificial material readily
removed. In alternative embodiments, fewer, more, or even no
release holes may be formed. In some embodiments, the components
may be formed using an interference bushings, or with intermediate
bearing elements, for example, to provide smoother operation or
tighter formation tolerances. In some alternative embodiments fluid
flow paths and outlets may exist between the components and may
receive a fluid during operation of the device so as to provide a
fluid bearing for improved device operation.
[0155] The device 100 can be a micro-scale device. Thus, the
diameter of the device 100 can be less than 5 mm, such as less than
3 mm, e.g. less than 1 mm. The minimum feature size can be on the
order of tens of microns, i.e. less than 100 microns, such as less
than 50 microns. Moreover, the precision of the device build can be
on the micron level, i.e. between 1 and 10 microns. Having a
micro-scale device can advantageously allow the device to be used
in small areas of the body that are unreachable by larger devices.
Moreover, the precision of the build and the minimum feature size
can be useful for very precise and specific tissue removal, such as
planing of tissue layers of only a few microns thick. These
micro-scale devices may be made using the electrochemical
fabrication process described above.
[0156] Various alternatives to this embodiment are possible and
include, for example, alternative blade configurations and intake
configurations. For example, the teeth of the cutting elements may
be made to encounter one another other than in a tip-to-tip
configuration, the teeth may be removed in favor of straight
blades, and the cutting blades may have cutting surfaces that have
lengths which extend not just radially but also have an azimuthal
component of length as well. In some embodiments, the cutting
elements may be provided with cutting surfaces to allow cutting in
either direction of rotation. In some alternative embodiments, the
intake opening, which is defined by the distal cap of component 111
may be made larger by decreasing the azimuthal sweep or extent of
the cap or smaller by increasing the azimuthal extent of the cap.
In some embodiments, different numbers of inner cutting elements
may form part of the inner component (e.g. 1, 2, 3, 4, or more
cutting elements), and different numbers of outer cutting elements
may form part of the outer component, and in some embodiments,
these numbers of inner and outer cutting elements need not match.
In some embodiments, cutting elements may be contained on a single
component, two components, or more than two components.
[0157] During use, the two components 101, 111 of this working end
of the cutting device may have their proximal ends joined or
otherwise coupled to tubes or other rotatable elements such that
one component (i.e. each including its respective cutting elements)
stays stationary while the other rotates, such the two components
101, 111 rotate in opposite directions, or such that the two
components 101, 111 rotate in the same direction but at different
rates such that they still move past one another to provide
shearing. During some uses, the components 101, 111 may be made to
periodically, or possibly upon input from sensors (e.g. an input
indicating a stall or excess slowing of the rotation), rotate a
partial rotation in reverse to provide an opportunity for
additional shearing attempts. During some uses, the cutting may be
accompanied by aspiration from distal to proximal end to provide
enhanced transport of sheared off material. In some embodiments,
aspiration may be accompanied by appropriately directed irrigation.
In some embodiments, more proximally located cutting and/or
transport elements can be included on the components 101, 111 to
cause further maceration of the removed material or proximal
transportation of the material.
[0158] In some alternative embodiments, the rotation of one or both
of the concentric components may occur via one or more rotating
tubes that may be located within a catheter. The tubes may be
driven by rotational driving elements located at a significant
distance from the working area that is being operated on (e.g.
outside the body of a patient). In other embodiments, the rotating
tubes or other elements may be driven by a fluid driven turbine
(e.g. driven by an irrigation fluid of other fluid) that is located
within the catheter or other instrumental lumen.
[0159] In some embodiments, the instrument components shown in
FIGS. 5A-5E may be formed using one of the multi-layer
multi-material fabrication processes set forth herein or
incorporated herein by reference. In some embodiments, one of the
components, or part the components may be made by one of these
multi-layer multi-material fabrication process while the other
component or component portions may be made by one or more
different processes. In still other embodiments, both of the
components may be made by processes other than multi-layer,
multi-material fabrication process. For example, one or both
components, or portions thereof may be made from a tube which is
cut to a desired shape and then bent to a desired configuration and
perhaps with portions welded or otherwise joined to maintain the
created configuration.
[0160] FIGS. 6A-6C provide various views of a working end of a
cutting device 200. The cutting device 200 includes first and
second components 201 and 211. The first component 201 includes an
inner cutting element 202, having a primary cutting surface 203 and
a secondary cutting surface 204. The second component 211 includes
an outer cutting element 212, having a primary surface 213 and a
secondary surface 214. One or both of the first and second
components 201, 211 is capable of rotating about a central
longitudinal axis 221 to cause relative rotation with respect to
one another. The interaction of cutting surfaces 203 and 204 with
cutting surfaces 213 and 214, respectively, during such relative
rotation can cause shearing away of tissue or other material as the
inner and outer cutting elements rotate past one another.
[0161] Both the inner and outer cutters 202, 212 can have
singled-sided radial extending, and slightly azimuthal extending,
primary cutting surfaces 203 and 213 as well as secondary cutting
surfaces 204 and 214 extending axially at the radial extremes of
the components. Teeth 205 and 215 can extend radially along the
primary and/or secondary cutting surfaces.
[0162] An intake window, such as an intake window 222 of the device
exists on one-half of the distal end of the cutting device 200. The
intake window 222 permits tissue to extend into the interior of
cutting device 200 to enable the interacting cutting surfaces of
the first and second components to shear the tissue, for example
during a planing process. Further, a distal cap of element 211 is
located on the other half of the distal end of the cutting device
200. The cutter 200 can have many of the same advantages of the
cutter 100. For example, the cutter 100 can be a micro-scale device
and can have thin axially-extending cutting surfaces, allowing for
access to small areas and specific and precise removal of very
small layers of tissue, such as during a planing process.
[0163] Numerous variations of the cutting device 200 exist, some of
which are similar, mutatis mutandis, to those noted above with
regard to the first embodiment.
[0164] FIGS. 7A-7B provide perspective and cut views of a working
end of a cutting device 300. The first component 301 of the device
300 includes an inner cutting element 302 having optional teeth 305
that extend perpendicular to the axis of rotation and a secondary
peripheral cutting surface 303 with axially-extending teeth 305.
The second component 311 is disposed radially outward from first
element 301 and includes an outer cutting element 312 with
axially-extending teeth 315. The first component 301 is capable of
rotating with respect to the second component 311, which causes
shearing at the periphery due to the interaction of cutting
surfaces 303 and 312 while the cutting surface 302 cuts a plane of
tissue. Sloped surface 306 helps draw material from the distal end
of the device toward the proximal end. In some embodiments, the
first component can also be configured to rotate. For example, the
first component can rotate counter-clockwise, and the second
component can rotate clockwise.
[0165] Both cutting surfaces 304 and 312 are provided with teeth in
a crown configuration, i.e. both have teeth extending axially. The
teeth can be used to drive into tissue. The teeth can have a
maximum radial thickness of less than 50 microns, such as
approximately 30 microns. Further, the teeth can have a pitch of
less than 200 microns, such as less than 100 microns. The device
300 can be used for coring and slicing a substantially circular
plane of tissue, i.e. for conducting a biopsy. The small teeth of
the cutting device 300 can allow for removal of very small tissue
samples, such as samples that are less than 5 microns, such as
between 2 and 5 microns. Removing such small samples avoids
excessive damage to surrounding tissue.
[0166] The intake window 322 of the device 300 covers nearly the
entire 360 degree azimuthal region of the components to allow
tissue to extend proximally into the device for shearing and easy
removal of the tissue sample for analysis. The device 300 can be a
micro-scale device, allowing it access to otherwise inaccessible
areas of the body and may be made using the electrochemical
fabrication process described above.
[0167] Numerous variations the cutting device 300 exist, some of
which are similar, mutatis mutandis, to those noted above with
regard to cutting device 100.
[0168] FIGS. 8, 9, 13, and 16 show components of devices similar to
device 300, i.e., that include axially-extending teeth. Thus, the
devices can include many of the same features and advantages as
device 300.
[0169] FIGS. 8 and 9 are similar to the cutting device 300 with the
exception that the cutter 400 (FIG. 8) has the outer crown cutting
teeth removed while the cutter 500 has both the inner and out crown
cutting teeth removed.
[0170] FIG. 13 provides a perspective view of a working end of a
cutting device 900 having first and second components 901 and 911.
Similar to the other cutting devices described herein, the cutting
device 900 includes teeth on each component 901, 911, respectively,
that can shear against each other during rotation of one or both of
the components 901, 911, to remove small pieces of tissue. Unlike
the embodiment of FIG. 7, the first component 901 of the embodiment
of FIG. 13 has two cutting elements 912 and two intake windows 914
for drawing in and removing tissue.
[0171] FIG. 16 provides a perspective view of a working end of a
cutting device 1200 having first and second components 1201 and
1211. The device includes inner and outer crown cutters having
teeth 1205 and 1215 extending substantially axially. The teeth 1205
are configured to bore into a material without any additional
cutting elements. This embodiment omits the inner cutting element
of the first component shown in FIG. 7.
[0172] Numerous variations on these embodiments are possible and
include those, mutatis mutandis, set forth regard to any of the
other embodiment set forth herein.
[0173] FIGS. 10A-10B provide a perspective and a perspective cut
view respectively of a working end of a cutting device 600. The
cutting device 600 includes first and second components 601 and 611
attached to a central shaft 640. The first component 601 includes
an inner cutting element 602, having two primary cutting surfaces
603 and two secondary cutting surfaces 604. The second component
611 includes two outer cutting elements 612, having a primary
surface 613 and a secondary surface 614. When assembled, first
component 601 is disposed radially inward of second component 611.
The first component 601 is capable of rotating relative to the
second component 611 to cause shearing away of tissue or other
material as the inner and outer cutting elements rotate past one
another. In some embodiments, the first component can also be
configured to rotate about the central longitudinal axis 621. For
example, the first component can rotate counter-clockwise, and the
second component can rotate clockwise.
[0174] Both the inner and outer cutters 602, 612 have two-sided
radial extending, and slightly azimuthal extending, primary cutting
surfaces 603 and 613, respectively. The primary cutting surfaces
603 and 613 can include teeth 607 and 617. Moreover, both the inner
and outer cutters 602, 612 have secondary cutting surfaces 604 and
614 extending axially at the radial extremes of the components,
which can also include teeth 605 and 615. An intake window 622 of
the device consists of two opposite facing 90 degree wedges for
drawing in tissue to be sheared between the rotating cutting
surfaces and two sloping surfaces for drawing the sheared tissue
proximally.
[0175] Advantageously, the distal end of the cutter 600 can have a
flat portion 630 that extends from the outer circumference to the
radial center of the cutter 600. The flat portion 630 can have an
axial thickness of less than 100 microns, such as less than 50
microns. The spatial relationships between the flat surface, the
cutting elements 603 and 613 and the intake windows 622 can allow
for removal of tissue along a single plane, such as during a
milling process, thereby avoiding removal of unwanted tissue.
[0176] Further, the cutter 600 can be a micro-scale device. Thus,
the diameter of the device 600 can be less than less than 5 mm,
such as less than 3 mm, e.g. less than 1 mm. The minimum feature
size (e.g., the size of teeth 605 and 615) can be on the order of
tens of microns, i.e. less than 100 microns, such as less than 50
microns. Moreover, the precision of the device build can be on the
micron level, i.e. between 1 and 10 microns. Having a micro-scale
milling device can advantageously allow the device to be used in
small areas of the body that are unreachable by larger devices.
Moreover, the precision of the build and the minimum feature size
can be useful for very precise and specific tissue or material
cutting. For example, tissue having a diameter of less than 5
microns, such as between 2 and 5 microns, can be removed during a
milling process. Removing such small pieces avoids excessive damage
to surrounding tissue. These micro-scale devices may be made using
the electrochemical fabrication process described above.
[0177] Numerous variations of the cutter 600 exist, some of which
are similar, mutatis mutandis, to those noted above. Additional
variations may include the removal of the central rod shaft or the
hollowing out of the shaft to form a ring element through which a
guide wire, imagining device or other component may extend. In
still other embodiment variations, the central rod may be a hollow
shaft with perforation and may be connected to a proximal tube
(e.g. with a rotatable coupling) that allows a flow of an
irrigation fluid to be directed into the working region e.g. for
aspiration along with removed material.
[0178] FIGS. 11, 12, 14, 15, 17, 23, 25 show similar devices to
device 600, i.e., that include two rotating portions having flat
distal surfaces. Thus, the devices can include many of the same
features and advantages as device 600 and may be made using the
electrochemical fabrication process described above.
[0179] FIGS. 11A and 11B provide a perspective and a perspective
cut view respectively of a working end of a cutting device 700
having first and second components 701 and 711. The cutting device
700 is similar to that of cutter 600 with the exception of a
different set of primary cutting blade configurations 703 and
713.
[0180] FIG. 12 provides a perspective view of a working end of a
cutting device 800 having first and second components 801 and 811
that are configured to be rotated with respect to each other, as in
the embodiments described above. The cutting device 800 has an
inner cutter similar to that of cutter 600 with the exception that
the central rod or shaft is removed so that a guide wire, imaging
device or other element may be extended down the central axis of
the device. The device also lacks an outer cutting element.
Numerous variations of cutter 800 exist some of which are similar,
mutatis mutandis, to those noted above with regard to the other
embodiments set forth herein above and herein after. An additional
variation of the device might include the complete removal of the
outer component 811 and any tube used to hold or control its motion
and instead simply allow the device to extend from and rotate
within a catheter or other delivery lumen.
[0181] FIG. 14 provides a perspective view of a working end of a
cutting device 1000 having first and second components 1001 and
1011. The device has an inner cutter 1006 similar to that of cutter
600 of the invention but lacks an outer cutter. Numerous variations
of cutter 1000 exist some of which are similar, mutatis mutandis,
to those noted above with regard to the other embodiments set forth
herein above and herein after. An additional variation of the
device might include the complete removal of the outer component
1011 and any tube used to hold or control its motion and instead
simply allow the device to extend from and rotate within a catheter
or other delivery lumen.
[0182] FIG. 15A-15B provide a perspective views of a working end of
a cutting device 1100 having first and second components 1101 and
1111. The device is similar to that of cutter 600 except that the
central shaft 1106 includes a hollow center 1107 with irrigation
apertures 1108. A rotating or non-rotating tube may be connected to
this central shaft to provide a flow of irrigation fluid. Numerous
variations of cutter 1100 exist some of which are similar, mutatis
mutandis, to those noted above with regard to the other embodiments
set forth herein above and herein after. Additional variations of
the device might include variations on the number, position and
orientation of the apertures so that a desired flow volume and flow
direction can be obtained.
[0183] FIGS. 17A-17C provide various perspective views of a working
end of a cutting device 1300 having first and second components
1301, 1311. Component 1301 includes a pair of inner pinch-off
cutters 1321, and component 1311 includes a pair of outer pinch-off
cutters 1330. In addition, the cutting device includes a third
inner component 1331. The device 1300 further includes a central
irrigation tube 1306 including passage 1307 and apertures 1308 that
forms part of component 1301. Relative rotation between cutters
1321 and 1331 shears tissue extending into the openings between the
cutters. Component 1331 provides a tube coupler that is capable of
relative rotation relative to the irrigation tube 1306 so that the
feed tube can provide fluid for irrigation but need not rotate in
unison with the inner cutter. The inside portion of the outer ring
of the component 1301 also include inward facing aperture 1318,
which may exist solely for fabrication purposes (e.g. release of
sacrificial material) or may provide for additional irrigation
fluid which may be supplied between a tube connecting to component
1301 and a tube connecting to component 1311. Numerous variations
on this embodiment are possible and include those, mutatis
mutandis, set forth regard to the various other embodiments set
forth herein. Other variations might include a coupling between the
irrigation tube and the inner cutting element so that these
components can rotate relative to one another.
[0184] FIG. 23 illustrates several embodiments of additional
cutting devices having rotating parts and a flat distal end. The
embodiments shown therein have features that include various
combinations or refinement of the features included in the other
embodiments presented herein.
[0185] FIGS. 20A-20H provide perspective views of a working end of
a cutting device 1600. The cutting device 1600 includes first and
second components 1601 and 1611 which can be rotated with respect
to each other. The components 1600, 1611 each include a conical
cutting element 1606, 1616 extending axially. The conical cutting
elements can together form a helical shape. The helical shape can
be advantageous for particular medical processes, such as
drilling,
[0186] The edges 1620 of conical element 1616 and edges 1621 of
conical element 1606 can be sharp such that the shearing action
from rotation of the edges relative to one another causes the
cutter 1600 to drill through material, such as tissue. Further, the
edges 1620 and 1621 can have a beveled shape. The beveled edges
1620 can advantageously promote shearing. The beveled edge can have
a thickness that is less than 10 microns, such as between 2 and 5
microns, allowing for precise tissue cutting.
[0187] The device 1600 also includes pairs of inner and outer
cutters elements 1602 and 1612, respectively, extending axially,
radially inward from ring-like base structures of components 1601
and 1611, and extending forward azimuthally, as part of components
1601 and 1611 respectively. Component 1601 also includes irrigation
channels 1607 leading to irrigation apertures 1608 and 1608' on the
cutting blade and on the ring-like base structure. The cutting
device 1600 can be a micro-scale device such that it can be used in
small areas of the body that are unreachable by larger devices,
such as blood vessels having a diameter of less than 5 mm, such as
less than 5 mm, such as less than 3 mm, e.g. less than 1 mm.
Moreover, the precision of the build and the minimum feature size
can be useful for very precise and specific tissue or material
cutting. For example, tissue having a diameter of less than 5
microns, such as between 2 and 5 microns, can be removed. Removing
such small samples avoids excessive damage to surrounding
tissue.
[0188] FIG. 20I provides an example layered device 1600' as the
devices of FIGS. 20A-20H might be formed from a plurality of
adhered layers which might be produced in a multi-layer,
multi-material fabrication process (e.g. the electrochemical
fabrication process described above).
[0189] Numerous variations on this embodiment are possible and
include those, mutatis mutandis, set forth regard to the various
other embodiments set forth herein. Other variations might include
inner and/or outer blade configuration that provide for tight
fitting blades while minimizing risk of tolerance based collisions
by offsetting regions of initial passing (e.g. tips) radially
inward (in the case of the inner cutting blades) or outward (in the
case of the outer blades) in to ensure smooth passing while
providing tightened ring-like base clearances or clearances on
portions of the blades that are recessed from the initial contact
regions. Variations of the device of this embodiment, like other
embodiments described herein, can also provide for an open central
region so that a guide wire, imaging device, or other tool or
instrument may be moved down the center of the cutting element. The
open central region may be defined by the blades themselves or by a
ring like structure, with or without, a coupling element through
which the central instrument may pass.
[0190] FIGS. 22 and 27 show similar devices to device 600, i.e.,
that include a conical-shaped distal end. Thus, the devices can
include many of the same features and advantages as device 600 and
may be made using the electrochemical fabrication process described
above.
[0191] FIGS. 22A-22B provide perspective views of a working end of
a cutting device 1800 having first and second components 1801 and
181. Variations of the device 1800 are similar, mutatis mutandis,
to those for the other embodiments, noted herein and as with the
other embodiments may include features or portions of features
found only within the other embodiments themselves. Variations of
the device may include a ring-like structure or structures which
guide movement for an instrument inserted through the center 1820
of the cutting device so that the instrument cannot inadvertently
get caught by the cutting blades themselves.
[0192] FIGS. 27A-27C provide various views of an example device
3000 including a working end of an example cutting element 1800
having its inner and outer cutting elements coupled to inner and
outer tubes 3001 and 3011 respectively which can be used to rotate
the cutting elements or to hold them stationary. FIGS. 27B and 27C
provide truncated views of the tubes so that the inner tube may be
seen. Variations of this embodiment may make use of the working
ends of the other embodiments set forth herein or variations
thereof. In other alternatives, the tubes or the working ends
themselves may include pivot elements or bendable elements to
provide a desired orientation to cutting elements when in use.
Further alternatives may include the use of additional tubes or
fewer tubes as appropriate. In use, various fluids or vacuum may be
applied between the tubes to provide desired lubrication,
irrigation, aspiration, drug delivery, or the like.
[0193] In some configurations, the cutting devices described herein
can be stacked or combined to further cut tissue brought into the
tube. Referring to FIGS. 28A-28B, the first device 1800 can include
an inner component 1801 and an outer component 1811, which can be
designed similar to any of the first and second components
described herein. A second device 1800' can be combined with the
first device 1800, such as stacked together axially as shown in
FIGS. 28A-28B. The second device 1800' can include an inner
component 1801' and an outer component 1811', which can be designed
similar to any of the first and second components described herein.
Optionally, as shown in FIGS. 28A-28B, the first device 1800 can be
a forward-facing cutter, while the second device 1800' can be a
backward-facing cutter relative to the control tubes.
[0194] Referring to FIGS. 18, 19, 21, 24, and 26, the cutting
devices described herein can be configured to include multiple
cutters along the axial and/or radial directions. Having multiple
cutters along the axial and/or radial directions can advantageously
allow for better shearing of tissue.
[0195] FIG. 18 provides a perspective view of a working end of a
cutting device 1400 having first and second components 1401, and
1411. Component 1401 includes a pair of inner pinch-off cutters
1421 spaced apart circumferentially, and component 1411 includes a
pair of outer pinch-off cutters 1431 spaced apart
circumferentially. The inner and outer cutting blades also include
interlaced side cutters 1441 that provide for side milling. The
side cutters 1441 can each include cutting surfaces 1442 that are
parallel to the central axis of the cutter 600. The cutting
surfaces 1442 can extend along the same radial plane. The side
cutters 1441 can be spaced apart axially. Moreover, each pinch-off
cutter 1421 can include a set of side cutters 1441 approximately
axially aligned thereto. Further, the side cutters 1441 can each
include parallel cutting surfaces 1443 extending perpendicular to
the central axis of the cutter 600. The outer component 1411 can
include similar cutting surfaces such that the side cutters of the
inner and outer components 1401 and 1411 can interlace with one
another. The axial thickness of each side cutter 1441 can be less
than 100 microns, such as less than 50 microns. The interaction of
the side cutters and/or the pinch-off cutters as one or both of the
components 1401, 1411 rotates can allow for shearing of tissue.
Numerous variations on this embodiment are possible and include
those, mutatis mutandis, set forth regard to the various other
embodiments set forth herein. Other variations might include
different numbers of interlaced elements, different thicknesses of
interlaced elements, and different interlacing depths for those
elements.
[0196] As shown in FIG. 19, a cutting device 1500 can include first
and second components 1501 and 1511. The device 1500 includes
stacked levels of cutters 1504 on primary cutting elements of both
the inner and outer components. The device 1500 further includes
side teeth 1514 that provide for retention and shredding of
material. The teeth of the inner and outer elements can both extend
perpendicular to the central axis of the device and can be located
on opposing planes so as to allow shearing when the components
1501, 1511 are rotated relative to one another. The teeth can have
an axial thickness of less than 100 microns, such as less than 50
microns, such as less than 10 microns. The device 1500 can also
include irrigation apertures on central shaft. Other variations
might include different numbers and configurations of stacked
cutter primary and secondary cutting teeth.
[0197] FIG. 21 provides a perspective view of a working end of a
cutting device 1700 having first and second components 1701, and
1711. The first component 1701 includes inner cutting blades 1703
spaced apart circumferentially, while the second component 1711
includes outer cutting blades 1713 spaced apart circumferentially.
The inner cutting blades 1703 are provided with outward facing side
teeth 1705 that interlace with inward facing side teeth 1715 on the
outer cutting blades 1711 to shear tissue as the first and second
components rotate with respect to each other. The teeth 1705 can be
stacked and spaced apart axially. The teeth 1705 can each include a
surface 1706 parallel to the central axis of the device and a
surface 1707 perpendicular to the central axis of the device. The
surfaces 1706 extending approximately parallel with each other can
each be located along a different radial dimension so as to create
a conical-shaped distal end of the device. Variations of the device
1700 are similar, mutatis mutandis, to those for the other
embodiments, noted herein and as with the other embodiments may
include features or portions of features found only within the
other embodiments themselves. Variations of the device may include
irrigation channels and apertures.
[0198] As shown in FIGS. 24A-24B, a cutting device 2000 can include
an outer component 2011 and an inner component 2001. The outer
component 2011 can include axially-extending cutting elements 2012.
The axially-extending cutting elements 2012 can each have a cutting
surface 2013 extending parallel to the central axis of the device
and a cutting surface 2014 extending perpendicular to the central
axis of the device. The axially-extending cutting elements can be
spaced apart radially and/or circumferentially. Likewise, the inner
component 2001 can include similar axially-extending elements 2002.
The axially extending elements 2002 can be spaced apart radially
and/or circumferentially. Further, the inner cutting element 2001
can include one or more sloped surfaces 2009 such that the inner
cutting elements 2001 can be spaced apart axially. The
axially-extending elements of each component can extend along a
common axial plane. The interaction of the surfaces of the cutting
elements 2012 and 2002 as one or both of the elements 2001, 2011
rotates, can allow for shearing of tissue. In the illustrated
embodiment, outer component 2011 has a shaft (not shown) that fits
into a bore 2010 formed in inner component 2001.
[0199] As shown in FIGS. 26A-26C, a cutting device 2200 can include
an inner component 2201 and an outer component 2211. The inner
component 2201 can include cutting surfaces 2202 having teeth 2203,
while the outer component 2211 can include cutting surfaces 2212
having 2213. Inner component 2201 and outer component 2211 may be
rotated with respect to each other so that cutting surfaces 2202
and 2212 can shear tissue extending through intake windows 2216.
Other embodiments are possible. For example, the inner cutting
element can include multiple cutters extending radially, while the
outer cutting element includes multiple cutters extending axially.
Alternatively, the inner cutting element can include multiple
cutters extending axially while the outer cutter element also
includes multiple cutters extending axially.
[0200] Further, referring to FIG. 29, the devices described herein,
due to their small features sizes and precise build, can
advantageously be configured to include ancillary components that
extend along the inner central axis and through an opening in the
distal end of the device. The cutting device 1900, representing any
of the cutting devices described herein, can include including
inner and outer cutting elements 1901 and 1911. A hole 2901 can
extend along the central axis of the cutting device 1900. As such,
an ancillary component 2905 can extend through the cutting device
1900. Referring to FIG. 30A, the ancillary component can be a
balloon 3060. Referring to FIG. 30B, the ancillary component can be
an umbrella 3062. Referring to FIG. 30C, the ancillary component
can be an imaging element 3064, such as a CMOS camera, a fiber
optic scope with CCD or CMOS, 2D and 3D capture and display,
ultrasound (IVUS), Doppler, or birefringence-insensitive optical
coherence tomography (OCT). Referring to FIG. 30D, the ancillary
component can be a needle 3066, such as drug delivery needle.
Referring to FIG. 30E, the ancillary component can be a
longitudinal element 3068 including barbs to, for example, gather
tissue and pull it towards the cutting elements or to stabilize
tissue during cutting. Referring to FIG. 30F, the ancillary
component can be a water jet tube 3072, such as a water jet tube
for delivering water to clear clots. Referring to FIG. 30G, the
ancillary component can be a guide wire 3074. Additional ancillary
components include a device for suction, a device for irrigation,
or an energy system to coagulate or cauterize, such as a system
providing RF energy, an argon beam, a laser, or a DC current.
[0201] In summary, various specific cylindrical cutting device
embodiments have been taught herein. These various device
embodiments may make use of various elements including: (1) designs
are driven with 2 concentric tubes; (2) cutting surfaces that face
forward with respect to the longitudinal axis of the tool or
instrument; (3) an inside tube is connected to one set of blades;
(4) an outside tube is connected to one set of blades; (5) an
inside tube is rotated with respect to the outside tubes, making
the cutting blades pass one another; (6) in some cases the outside
tube can be rotated in either direction at a different rate than
the inside tube to expose all blades to the tissue at all azimuthal
angles (this allows cutting over the entire front surface of the
targeted area); (7) the various device embodiments can be attached
to articulating tubes so that the cutting end can be steerable; (8)
the various device embodiments can incorporate aspiration to remove
the material that has been cut; (9) some embodiments may provide
turbine or propeller-like effects which will help material
transport away from the targeted area; (10) some embodiments may
incorporate irrigation to aid in the material transport; (11) some
embodiments may incorporate central imaging; (12) some embodiments
may be deliverable via a central guide wire; (13) various
embodiments are scalable to different radial sizes from less than
one-half millimeter to more than a centimeter; and/or (14) some
embodiments may be assisted by one or more proximally located
supplement cutters, shredders, or mechanical flow assist
devices.
Further Comments and Conclusions
[0202] Structural or sacrificial dielectric materials may be
incorporated into embodiments of the present invention in a variety
of different ways. Such materials may form a third material or
higher deposited on selected layers or may form one of the first
two materials deposited on some layers. Additional teachings
concerning the formation of structures on dielectric substrates
and/or the formation of structures that incorporate dielectric
materials into the formation process and possibility into the final
structures as formed are set forth in a number of patent
applications filed Dec. 31, 2003. The first of these filings is
U.S. Patent Application No. 60/534,184 which is entitled
"Electrochemical Fabrication Methods Incorporating Dielectric
Materials and/or Using Dielectric Substrates". The second of these
filings is U.S. Patent Application No. 60/533,932, which is
entitled "Electrochemical Fabrication Methods Using Dielectric
Substrates". The third of these filings is U.S. Patent Application
No. 60/534,157, which is entitled "Electrochemical Fabrication
Methods Incorporating Dielectric Materials". The fourth of these
filings is U.S. Patent Application No. 60/533,891, which is
entitled "Methods for Electrochemically Fabricating Structures
Incorporating Dielectric Sheets and/or Seed layers That Are
Partially Removed Via Planarization". A fifth such filing is U.S.
Patent Application No. 60/533,895, which is entitled
"Electrochemical Fabrication Method for Producing Multi-layer
Three-Dimensional Structures on a Porous Dielectric". Additional
patent filings that provide teachings concerning incorporation of
dielectrics into the EFAB process include U.S. patent application
Ser. No. 11/139,262, filed May 26, 2005 by Lockard, et al., and
which is entitled "Methods for Electrochemically Fabricating
Structures Using Adhered Masks, Incorporating Dielectric Sheets,
and/or Seed Layers that are Partially Removed Via Planarization";
and U.S. patent application Ser. No. 11/029,216, filed Jan. 3, 2005
by Cohen, et al., now abandoned, and which is entitled
"Electrochemical Fabrication Methods Incorporating Dielectric
Materials and/or Using Dielectric Substrates". These patent filings
are each hereby incorporated herein by reference as if set forth in
full herein.
[0203] Some embodiments may employ diffusion bonding or the like to
enhance adhesion between successive layers of material. Various
teachings concerning the use of diffusion bonding in
electrochemical fabrication processes are set forth in U.S. patent
application Ser. No. 10/841,384 which was filed May 7, 2004 by
Cohen et al., now abandoned, which is entitled "Method of
Electrochemically Fabricating Multilayer Structures Having Improved
Interlayer Adhesion" and which is hereby incorporated herein by
reference as if set forth in full. This application is hereby
incorporated herein by reference as if set forth in full.
[0204] Some embodiments may incorporate elements taught in
conjunction with other medical devices as set forth in various U.S.
patent applications filed by the owner of the present application
and/or may benefit from combined use with these other medical
devices: Some of these alternative devices have been described in
the following previously filed patent applications: (1) U.S. patent
application Ser. No. 11/478,934, by Cohen et al., and entitled
"Electrochemical Fabrication Processes Incorporating Non-Platable
Materials and/or Metals that are Difficult to Plate On"; (2) U.S.
patent application Ser. No. 11/582,049, by Cohen, and entitled
"Discrete or Continuous Tissue Capture Device and Method for
Making"; (3) U.S. patent application Ser. No. 11/625,807, by Cohen,
and entitled "Microdevices for Tissue Approximation and Retention,
Methods for Using, and Methods for Making"; (4) U.S. patent
application Ser. No. 11/696,722, by Cohen, and entitled "Biopsy
Devices, Methods for Using, and Methods for Making"; (5) U.S.
patent application Ser. No. 11/734,273, by Cohen, and entitled
"Thrombectomy Devices and Methods for Making"; (6) U.S. Patent
Application No. 60/942,200, by Cohen, and entitled "Micro-Umbrella
Devices for Use in Medical Applications and Methods for Making Such
Devices"; and (7) U.S. patent application Ser. No. 11/444,999, by
Cohen, and entitled "Microtools and Methods for Fabricating Such
Tools". Each of these applications is incorporated herein by
reference as if set forth in full herein.
[0205] Though the embodiments explicitly set forth herein have
considered multi-material layers to be formed one after another. In
some embodiments, it is possible to form structures on a
layer-by-layer basis but to deviate from a strict planar layer on
planar layer build up process in favor of a process that interlaces
material between the layers. Such alternative build processes are
disclosed in U.S. application Ser. No. 10/434,519, filed on May 7,
2003, now U.S. Pat. No. 7,252,861, entitled Methods of and
Apparatus for Electrochemically Fabricating Structures Via
Interlaced Layers or Via Selective Etching and Filling of Voids.
The techniques disclosed in this referenced application may be
combined with the techniques and alternatives set forth explicitly
herein to derive additional alternative embodiments. In particular,
the structural features are still defined on a
planar-layer-by-planar-layer basis but material associated with
some layers are formed along with material for other layers such
that interlacing of deposited material occurs. Such interlacing may
lead to reduced structural distortion during formation or improved
interlayer adhesion. This patent application is herein incorporated
by reference as if set forth in full.
[0206] The patent applications and patents set forth below are
hereby incorporated by reference herein as if set forth in full.
The teachings in these incorporated applications can be combined
with the teachings of the instant application in many ways: For
example, enhanced methods of producing structures may be derived
from some combinations of teachings, enhanced structures may be
obtainable, enhanced apparatus may be derived, and the like.
TABLE-US-00001 US Pat App No., Filing Date US App Pub No., Pub Date
US Patent No., Pub Date Inventor, Title 09/493,496 - Jan. 28, 2000
Cohen, "Method For Electrochemical Fabrication" U.S. Pat. No.
6,790,377 - Sep. 14, 2004 10/677,556 - Oct. 1, 2003 Cohen,
"Monolithic Structures Including Alignment and/or 2004-0134772 -
Jul. 15, 2004 Retention Fixtures for Accepting Components"
10/830,262 - Apr. 21, 2004 Cohen, "Methods of Reducing Interlayer
Discontinuities in 2004-0251142A - Dec. 16, 2004 Electrochemically
Fabricated Three-Dimensional Structures" U.S. Pat. No. 7,198,704 -
Apr. 3, 2007 10/271,574 -Oct. 15, 2002 Cohen, "Methods of and
Apparatus for Making High Aspect 2003-0127336A - Jul. 10, 2003
Ratio Microelectromechanical Structures" U.S. Pat. No. 7,288,178 -
Oct. 30, 2007 10/697,597 - Dec. 20, 2002 Lockard, "EFAB Methods and
Apparatus Including Spray 2004-0146650A - Jul. 29, 2004 Metal or
Powder Coating Processes" 10/677,498 - Oct. 1, 2003 Cohen,
"Multi-cell Masks and Methods and Apparatus for 2004-0134788 - Jul.
15, 2004 Using Such Masks To Form Three-Dimensional Structures"
U.S. Pat. No. 7,235,166 - Jun. 26, 2007 10/724,513 - Nov. 26, 2003
Cohen, "Non-Conformable Masks and Methods and 2004-0147124 - Jul.
29, 2004 Apparatus for Forming Three-Dimensional Structures" U.S.
Pat. No. 7,368,044 - May 6, 2008 10/607,931- Jun. 27, 2003 Brown,
"Miniature RF and Microwave Components and 2004-0140862 - Jul. 22,
2004 Methods for Fabricating Such Components" U.S. Pat. No.
7,239,219 - Jul. 3, 2007 10/841,100 - May 7, 2004 Cohen,
"Electrochemical Fabrication Methods Including Use 2005-0032362 -
Feb. 10, 2005 of Surface Treatments to Reduce Overplating and/or
U.S. Pat. No. 7,109,118 - Sep. 19, 2006 Planarization During
Formation of Multi-layer Three- Dimensional Structures" 10/387,958
- Mar. 13, 2003 Cohen, "Electrochemical Fabrication Method and
2003-022168A - Dec. 4, 2003 Application for Producing
Three-Dimensional Structures Having Improved Surface Finish"
10/434,494 - May 7, 2003 Zhang, "Methods and Apparatus for
Monitoring Deposition 2004-0000489A - Jan. 1, 2004 Quality During
Conformable Contact Mask Plating Operations" 10/434,289 - May 7,
2003 Zhang, "Conformable Contact Masking Methods and 20040065555A -
Apr. 8, 2004 Apparatus Utilizing In Situ Cathodic Activation of a
Substrate" 10/434,294 - May 7, 2003 Zhang, "Electrochemical
Fabrication Methods With 2004-0065550A - Apr. 8, 2004 Enhanced Post
Deposition Processing" 10/434,295 - May 7, 2003 Cohen, "Method of
and Apparatus for Forming Three- 2004-0004001A - Jan. 8, 2004
Dimensional Structures Integral With Semiconductor Based Circuitry"
10/434,315 - May 7, 2003 Bang, "Methods of and Apparatus for
Molding Structures 2003-0234179 A - Dec. 25, 2003 Using Sacrificial
Metal Patterns" U.S. Pat. No. 7,229,542 - Jun. 12, 2007 10/434,103
- May 7, 2004 Cohen, "Electrochemically Fabricated Hermetically
Sealed 2004-0020782A - Feb. 5, 2004 Microstructures and Methods of
and Apparatus for U.S. Pat. No. 7,160,429 - Jan. 9, 2007 Producing
Such Structures" 10/841,006 - May 7, 2004 Thompson,
"Electrochemically Fabricated Structures Having 2005-0067292 - May
31, 2005 Dielectric or Active Bases and Methods of and Apparatus
for Producing Such Structures" 10/434,519 - May 7, 2003 Smalley,
"Methods of and Apparatus for Electrochemically 2004-0007470A -
Jan. 15, 2004 Fabricating Structures Via Interlaced Layers or Via
Selective U.S. Pat. No. 7,252,861 - Aug. 7, 2007 Etching and
Filling of Voids" 10/724,515 - Nov. 26, 2003 Cohen, "Method for
Electrochemically Forming Structures 2004-0182716 - Sep. 23, 2004
Including Non-Parallel Mating of Contact Masks and U.S. Pat. No.
7,291,254 - Nov. 6, 2007 Substrates" 10/841,347 - May 7, 2004
Cohen, "Multi-step Release Method for Electrochemically
2005-0072681 - Apr. 7, 2005 Fabricated Structures" 60/533,947 -
Dec. 31, 2003 Kumar, "Probe Arrays and Method for Making"
60/534,183 - Dec. 31, 2003 Cohen, "Method and Apparatus for
Maintaining Parallelism of Layers and/or Achieving Desired
Thicknesses of Layers During the Electrochemical Fabrication of
Structures" 11/733,195 - Apr. 9, 2007 Kumar, "Methods of Forming
Three-Dimensional Structures 2008-0050524 - Feb. 28, 2008 Having
Reduced Stress and/or Curvature" 11/506,586 - Aug. 8, 2006 Cohen,
"Mesoscale and Microscale Device Fabrication 2007-0039828 - Feb.
22, 2007 Methods Using Split Structures and Alignment Elements"
10/949,744 - Sep. 24, 2004 Lockard, "Three-Dimensional Structures
Having Feature 2005-0126916 - Jun. 16, 2005 Sizes Smaller Than a
Minimum Feature Size and Methods U.S. Pat. No. 7,498,714 - Mar. 3,
2009 for Fabricating"
[0207] Though various portions of this specification have been
provided with headers, it is not intended that the headers be used
to limit the application of teachings found in one portion of the
specification from applying to other portions of the specification.
For example, it should be understood that alternatives acknowledged
in association with one embodiment, are intended to apply to all
embodiments to the extent that the features of the different
embodiments make such application functional and do not otherwise
contradict or remove all benefits of the adopted embodiment.
Various other embodiments of the present invention exist. Some of
these embodiments may be based on a combination of the teachings
herein with various teachings incorporated herein by reference.
[0208] In view of the teachings herein, many further embodiments,
alternatives in design and uses of the embodiments of the instant
invention will be apparent to those of skill in the art. As such,
it is not intended that the invention be limited to the particular
illustrative embodiments, alternatives, and uses described above
but instead that it be solely limited by the claims presented
hereafter.
* * * * *