U.S. patent application number 15/522216 was filed with the patent office on 2017-11-23 for progressive flexibility catheter support frame.
The applicant listed for this patent is OrbusNeich Medical, Inc.. Invention is credited to Robert J. Cottone.
Application Number | 20170333675 15/522216 |
Document ID | / |
Family ID | 55851493 |
Filed Date | 2017-11-23 |
United States Patent
Application |
20170333675 |
Kind Code |
A1 |
Cottone; Robert J. |
November 23, 2017 |
PROGRESSIVE FLEXIBILITY CATHETER SUPPORT FRAME
Abstract
Cut-pattern designs creating a frame structure from a solid
tube, which may be used as a portion of medical device, such as a
catheter. The tube includes a plurality of units of cutout segments
which are distributed in band around a circumference of the tube. A
tube can have multiple different zones, each having units with
varying cutout segments. The cutout segments can have varying
cutout surface area allowing the flexibility of the tube to be
modified at any point along the tube by altering the cutout surface
area with zones having greater cutout surface areas as compared to
another zone are more flexible. The tube can be incorporated into a
catheter.
Inventors: |
Cottone; Robert J.; (Davie,
FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
OrbusNeich Medical, Inc. |
Fort Lauderdale |
FL |
US |
|
|
Family ID: |
55851493 |
Appl. No.: |
15/522216 |
Filed: |
November 4, 2015 |
PCT Filed: |
November 4, 2015 |
PCT NO: |
PCT/US15/58969 |
371 Date: |
April 26, 2017 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
62075177 |
Nov 4, 2014 |
|
|
|
62238428 |
Oct 7, 2015 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/0043 20130101;
A61M 25/0054 20130101; A61M 2025/0047 20130101; A61M 25/0662
20130101; A61M 25/0023 20130101; A61M 2205/0266 20130101; A61M
25/0051 20130101; A61M 2025/006 20130101; A61M 25/0069 20130101;
A61M 25/0013 20130101; A61M 25/0045 20130101; A61M 25/0102
20130101 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61M 25/01 20060101 A61M025/01; A61M 25/06 20060101
A61M025/06 |
Claims
1-14. (canceled)
15. A guide catheter extension comprising: a tube comprising at
least one zone along a portion of the length of the tube, the zone
comprising a plurality of units, wherein the units of the zone are
distributed circumferentially around the tube in at least one first
band, each unit of the zone comprises at least one cutout segment
that is oriented around a center of symmetry, wherein the center of
symmetry of each unit in the band is positioned equally from the
center of symmetry of an adjacent unit in the same band and the
center of symmetry of each unit is positioned at the same point on
the circumference of the tube as the center of symmetry of a second
unit in a third band which is separated by one band from the first
band; a skived collar transition section disposed adjacent the
tube, the transition section having a tapered edge, a short end and
a long end; and a push rod attached at the long end of the
transition section.
16. The guide catheter extension of claim 15, wherein each unit
comprises three cutout segments extending radially from a center of
symmetry of the unit, wherein each cutout segment of the unit is
positioned 120.degree. degrees from the other cutout segments in
the unit in the band.
17. The guide catheter extension of claim 16, further comprising
seven zones, a first zone, a second zone, a third zone, a fourth
zone, a fifth zone, a sixth zone and a seventh zone, each zone
having is formed from a plurality of units, wherein rank order of
cutout surface area and cut-pattern perimeter length is: unit of
the first zone <unit of the second zone <unit of the third
zone <unit of the fourth zone <unit of the fifth zone
<unit of the sixth zone <unit of the seventh zone.
18. The guide catheter extension of claim 17, wherein the zones are
arranged in sequence as first zone, second zone, third zone, fourth
zone, fifth zone, sixth zone and seventh zone.
19. The guide catheter extension of claim 15, wherein the cutout
segments are in the shape of a hexagon.
20. (canceled)
21. The guide catheter extension of claim 15, wherein the diameter
of the tube tapers from a proximal end to a distal end.
22-23. (canceled)
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to U.S. Provisional
Application No. 62/075,177, filed Nov. 4, 2014, and U.S.
Provisional Application No. 62/238,428, filed Oct. 7, 2015, the
disclosures of which are incorporated by reference herein in their
entirety.
FIELD OF THE INVENTION
[0002] The invention relates to a series of cut-pattern designs
which create a frame structure from a solid tube and which may be
used as a portion of medical device, such as a catheter.
BACKGROUND
[0003] In coronary artery disease, the coronary arteries may be
narrowed or occluded by atherosclerotic plaques or other lesions.
These lesions may totally obstruct the lumen of the artery or may
dramatically narrow the lumen of the artery. In order to diagnose
and treat obstructive coronary artery disease it is commonly
necessary to pass a guidewire or other instruments through and
beyond the occlusion or stenosis of the coronary artery.
[0004] Percutaneous coronary intervention (PCI), also known as
coronary angioplasty, is a therapeutic procedure used to treat the
narrowed or stenotic section of the coronary artery of the heart
due to coronary lesions or obstructions. A guide catheter may be
used in PCI to provide support an easier passage for another
catheter or device (microcatheter, stents, balloons, etc.) to
access the target site. For example, a guide catheter can be
inserted through the aorta and into the ostium of the coronary
artery. Once seated in the opening or ostium of the artery to be
treated, a guidewire or other instrument is passed through the
lumen of the guide catheter and then inserted into the artery
distal to the occlusion or stenosis. Another example for the use of
a guide catheter is shown where the guide catheter can be inserted
through the aorta and into the peripheral anatomy enabling access,
for example, to the femoral artery down through the popliteal
artery. This procedure allows for access to vasculature below the
knee.
[0005] However, guide catheters may encounter certain difficulties.
The anatomy in the area for placement, e.g., the coronary
vasculature, may be tortuous and the lesions themselves may be
comparatively non-compliant. Moreover, when crossing comparatively
non-compliant lesions, a backward force sufficient to dislodge the
guide catheter from the ostium of the artery being treated can be
generated. For example, in order to improve backup support, U.S.
Re. 45,830, assigned to Vascular Solutions, Inc., discloses a
coaxial guide catheter which is adapted to be passable within a
guide catheter. The distal portion of the coaxial guide can be
extended distally from the distal end of the guide catheter. The
coaxial guide catheter includes a flexible tip portion defining a
tubular structure having a lumen through which interventional
cardiology devices such as stents and balloons can be inserted and
a substantially rigid portion proximal of and more rigid than the
flexible tip portion that defines a rail structure without a
lumen.
[0006] Facilitating equipment delivery is the most common
indication for using a guide catheter. Other indicates include,
thrombectomy, facilitating interventions in chronic total occlusion
(CTO)s and selective contrast injection into the vasculature.
Duaong et al. J. Invasive Cardiol 27(10):E211-E215 (2015).
[0007] As illustrated in FIG. 1A, which is a depiction of a
commercial product "Guideliner.RTM." from Vascular Solutions, Inc.,
a guide catheter extension 100 includes a distal portion 110 having
a full circumference, a half-pipe portion 120, a collar transition
115 which provides a rapid-exchange type access point to insert
interventional devices (e.g., balloons, stents, etc.), a push rod
130, and a proximal tab 140 for manual manipulation of the guide
catheter extension 100.
[0008] Another device is Guidezilla.RTM. from Boston Scientific
Corp. FIG. 1B depicts a commercial guide catheter extension
product. Compared to FIG. 1A, this product lacks an explicit
half-pipe section, and instead uses a skived or tapered collar
transition which is directly connected to a push rod or rail.
[0009] To date the guide catheter extension devices disclosed or
available requires construction of different tube portions of
different characteristics and joining these tube portions together.
For example, as disclosed in U.S. Re 45,830, the catheter extension
includes a soft tip, a reinforced portion that is made of braided
or coil reinforced polymeric section (e.g., PTFE
(polytetrafluoroethylene) (liner and Pebax as the exterior), and a
substantially rigid portion which may be made of stainless steel or
nitinol tube. For the Guidezella.RTM. catheter, the collar
transition is made of a different material than the tubular portion
which has a reinforced portion formed from multi-filament braided
wire to reinforced the polymeric section. This structure makes
fabrication complicated.
[0010] Prior art designs for catheter tube bodies that have varying
degrees of flexibility along the long or longitudinal axis often
employ spiral cuts or interrupted spiral cuts along part of the
tube segment. Parameters of the spiral cuts, such as cut pitch
angle, cut widths, cut lengths, etc., are varied in order to
provide the varying degrees of flexibility to the catheter
shaft.
[0011] However, there remains a need for improved design for
catheter extensions, and more generally, alternative designs for
catheter tubes, that allow not only ease of fabrication, but also
control of various characteristics of the tube, e.g., steerability,
variable bending flexibility along the working length, pushability,
collapse or kink resistance, etc., at any point along the tube.
SUMMARY OF THE INVENTION
[0012] The invention provides for a tube, comprising, at least one
zone positioned along a portion of the length of the tube, the zone
comprising a plurality of units, where the units of the zone are
distributed circumferentially around the tube in at least one first
band, each unit of the zone comprises at least one cutout segment
that is oriented around a center of symmetry, where the center of
symmetry of each unit in the band is positioned equally from the
center of symmetry of an adjacent unit in the same band and the
center of symmetry of each unit is positioned at the same point on
the circumference of the tube as the center of symmetry of a second
unit in a third band which is separated by one band from the first
band. The tube could have 2-100 zones and there can be 2-1000 bands
in each zone.
[0013] In one embodiment, the unit comprises three cutout segments
extending radially from a center of symmetry of the unit, where
each cutout segment of the unit is positioned 120.degree. degrees
from the other cutout segments in the unit in the band. In this
three cutout embodiment, there can be seven zones, a first zone, a
second zone, a third zone, a fourth zone, a fifth zone, a sixth
zone and a seventh zone, each zone is formed from a plurality of
units, where rank order of cutout surface area and cut-pattern
perimeter length is: units of the first zone <unit of the second
zone <unit of the third zone <unit of the fourth zone
<unit of the fifth zone <unit of the sixth zone <unit of
the seventh zone. The zones can be arranged in sequence as first
zone, second zone, third zone, fourth zone, fifth zone, sixth zone
and seventh zone.
[0014] Alternatively, the cutout segments are in the shape of a
hexagon. This hexagon cutout embodiment can have seven zones, a
first zone, a second zone, a third zone, a fourth zone, a fifth
zone, a sixth zone and a seventh zone, each zone is formed from a
plurality of units, where rank order of cutout surface area and
cut-pattern perimeter length is: unit of the first zone <unit of
the second zone <unit of the third zone <unit of the fourth
zone <unit of the fifth zone <unit of the sixth zone <unit
of the seventh zone.
[0015] The tube can be made from a metallic material, such as
nitinol or stainless steel.
[0016] The tube can further comprise a section which has a spiral
cut section along a portion of the length of the tube and the
spiral cut section can be contiguous with the zone of the tube. The
spiral cut section may be an interrupted spiral cut.
[0017] In another embodiment, the cutout segments are in the shape
of a circle.
[0018] The invention comprises a guide catheter extension
comprising: a tube comprising, at least one zone along a portion of
the length of the tube, the zone comprising a plurality of units,
where the units of the zone are distributed circumferentially
around the tube in at least one band, each unit of the zone
comprises at least one cutout segment that is oriented around a
center of symmetry, where the center of symmetry of each unit in
the band is positioned equally from the center of symmetry of an
adjacent unit in the same band; a skived collar transition section
disposed adjacent the tube, the transition section having a tapered
edge, a short end and a long end; and a push rod attached at the
long end of the transition section. In this embodiment, each unit
comprises three cutout segments extending radially from a center of
symmetry of the unit, where each cutout segment of the unit is
positioned 120.degree. degrees from the other cutout segments in
the unit in the band. The tube can comprise seven zones, a first
zone, a second zone, a third zone, a fourth zone, a fifth zone, a
sixth zone and a seventh zone, each zone having is formed from a
plurality of units, wherein rank order of cutout surface area and
cut-pattern perimeter length is: unit of the first zone <unit of
the second zone <unit of the third zone <unit of the fourth
zone <unit of the fifth zone <unit of the sixth zone <unit
of the seventh zone. The zones can be arranged in sequence as first
zone, second zone, third zone, fourth zone, fifth zone, sixth zone
and seventh zone.
[0019] In another embodiment, the cutout segments are in the shape
of a hexagon in tube of the guide catheter extension.
[0020] In a further embodiment, the guide catheter extension can
comprise: a tube comprising, at least one zone along a portion of
the length of the tube, the zone comprising a plurality of units,
where the units of the zone are distributed circumferentially
around the tube in at least one band, each unit of the zone
comprises at least one cutout segment that is oriented around a
center of symmetry, where the center of symmetry of each unit in
the band is positioned equally from the center of symmetry of an
adjacent unit in the same band; a flared bib, that is substantially
perpendicular to the long axis of the tube, which has a greater
diameter than the outer diameter of the tube; and, a push rod
attached at the long end of the transition section.
[0021] In various embodiments, the diameter of the tube can taper
from a proximal end to a distal end.
[0022] The tube of the guide catheter extension can further
comprise a section where the tube has a spiral cut section along a
portion of the length of the tube and the spiral cut section is
contiguous with the zone of the tube. The spiral cut section can be
an interrupted spiral cut.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1A depicts a prior art catheter extension device.
[0024] FIG. 1B depicts another prior art catheter extension
device.
[0025] FIG. 2A is an unrolled or flat view of a tube having triplex
cut patterns according to some embodiments of the present
invention.
[0026] FIG. 2B is another unrolled or flat view of a tube having
triplex cut patterns as depicted in FIG. 2A, which includes 7
triplex zones (Zone 1 to Zone 7).
[0027] FIG. 2C is another unrolled or flat view of a tube in FIG.
2A.
[0028] FIG. 2D is another unrolled or flat view of a tube in FIG.
2C showing the center of symmetry across the tube.
[0029] FIG. 3A shows the details of the unit in zone 1.
[0030] FIG. 3B shows cutout perimeter of the unit in zone 1.
[0031] FIG. 4A shows the details of the unit in zone 2.
[0032] FIG. 4B shows cutout perimeter of the unit in zone 2.
[0033] FIG. 5A shows the details of the unit in zone 3.
[0034] FIG. 5B shows cutout perimeter of the unit in zone 3.
[0035] FIG. 6A shows the details of the unit in zone 4.
[0036] FIG. 6B shows cutout perimeter of the unit in zone 4.
[0037] FIG. 7A shows the details of the unit in zone 5.
[0038] FIG. 7B shows cutout perimeter of the unit in zone 5.
[0039] FIG. 8A shows the details of the unit in zone 6.
[0040] FIG. 8B shows cutout perimeter of the unit in zone 6.
[0041] FIG. 9A shows the details of the unit in zone 7.
[0042] FIG. 9B shows cutout perimeter of the unit in zone 7.
[0043] FIG. 10A-10H show the transition across zones 1 to 7.
[0044] FIG. 11A shows the cutout for a tube composed of zone 1.
[0045] FIG. 11B shows the cutout for a tube composed of zone 3.
[0046] FIG. 11C shows the cutout for a tube composed of zone 4.
[0047] FIG. 11D shows the cutout for a tube composed of zone 5.
[0048] FIG. 11E shows the cutout for a tube composed of zone 6.
[0049] FIG. 11F shows the cutout for tube composed of zones 1, 3,
5, 5 and 6.
[0050] FIG. 12A shows further details for the unit of zone 7.
[0051] FIGS. 12B, 12C show photomicrographs with a reduction in
width (strut width) from 10%, and 50%, respectively.
[0052] FIG. 13 is an unrolled plan view of a tube having hybrid cut
patterns including a spiral cut section and a section having a
triplex cut pattern, according to one embodiment of the present
invention.
[0053] FIG. 14A is a side cross sectional view of a portion of a
guide catheter extension including multiple triplex pattern zones
according to one embodiment of the present invention.
[0054] FIG. 14B is an unrolled or flat view of a portion of a guide
catheter extension including a single triplex pattern zone
according to one embodiment of the present invention.
[0055] FIG. 14C is a photo of the portion of the guide catheter
extension having the cut-pattern shown in FIG. 14B.
[0056] FIG. 14D shows a detail of a portion of FIG. 14B having
transverse cuts.
[0057] FIG. 15A is a schematic side view of a guide catheter
extension having a generally longitudinal cut according to certain
embodiments of the present invention.
[0058] FIG. 15B is a schematic top view of the guide catheter
extension shown in FIG. 15A.
[0059] FIG. 15C is a schematic top view of the guide catheter
extension when split open along the longitudinal cut shown in FIGS.
15A and 15B.
[0060] FIG. 15D is a 3D rendering of the guide catheter extension
in 15A.
[0061] FIG. 15E is a 3D rendering of a top down view the guide
catheter extension in 15D.
[0062] FIG. 15F is a 3D rendering of a side view the guide catheter
extension in 15D.
[0063] FIG. 16A shows certain components of a distal portion of a
catheter according to an embodiment of the present invention.
[0064] FIG. 16B shows the distal portion as assembled from the
components shown in FIG. 16A.
[0065] FIG. 16C shows a partial sectional view of the distal
portion as depicted in FIG. 16B.
[0066] FIGS. 16D-16E show partial sectional views of various parts
of the distal portion as depicted in FIG. 16B.
[0067] FIG. 17A shows a guide catheter extension having an attached
sealer according to one embodiment of the present invention.
[0068] FIG. 17B-17D show various configurations of a sealer
according to certain embodiments of the present invention.
[0069] FIG. 18A is a schematic side view of a guide catheter
extension having an end with a flared bib contained in a guide
catheter, according to some embodiments of the present
invention.
[0070] FIG. 18B is a cross-sectional view of the guide catheter
extension and the guide catheter depicted in FIG. 18A.
[0071] FIG. 18C is a schematic side view of a guide catheter
extension having a skived collar transition section with a flared
bib contained in a guide catheter, according to some embodiments of
the present invention.
[0072] FIG. 18D is a cross-sectional view of the guide catheter
extension and the guide catheter depicted in FIG. 18C.
[0073] FIG. 19 depicts a guide catheter extension having a skived
collar transition section with a flared bib and a tube portion
having varying diameter.
[0074] FIG. 20 shows the guide catheter assembly with an assembled
handle.
DETAILED DESCRIPTION
[0075] The present invention generally relates to multiple
cut-pattern designs for a tubular structure (or tube) of a medical
device for interventional procedures that can be passed through a
portion of a patient's vasculature or into other body lumens, such
as guiding catheters, guide catheter extensions, micro-catheters,
as well as other catheter tubes. A tube (or a portion thereof) may
be substantially uniform in diameter across its entire length.
Alternatively, the tube can have a varying diameter across its
length, e.g., a tapered configuration. The tapering can be in any
direction and may only be present along a portion of the tube. The
tube can be made from a metallic material (e.g., stainless steel)
or metal alloy, for example, a shape memory material such as
nitinol which renders the tube kink resistant. Alternatively, the
tube can be formed from polymers, glass filled polymers or a
metal-polymer composite. The exterior surface of tube, which can
have the desired cut or etched patterns, can be further
encapsulated or covered with a polymeric jacket material, and the
inner surface of the tube can be lined with a polymer inner lining
which has a smooth, lubricous surface.
[0076] One embodiment of the tube cut patterns of the invention is
shown in FIGS. 2A and 2B. A tube 200 having a longitudinal axis 203
(L), a proximal end 201, a distal end 202, and a body or tube wall.
The tube wall has cut patterns which include a plurality of zones,
1-7, which are arranged along the longitudinal axis L. The zones
can be along any portion of the tube or a single zone may comprise
the entire tube. The length of the tube is shown as LA. Each zone
includes a plurality of units (or groups) of radially symmetric,
cutout segments that are distributed around the circumference of
the tube in a band or row. A band or row can have 2, 3, 4, 5, 6, 7,
8, 9, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400, 500,
1000 to n units. In FIGS. 2A and 2B there are 5 units in each band
or row. The number of units per band or row may be the same or
different in two different zones. As shown in FIG. 2B, a unit from
each of the 7 zones is identified as 210, 220, 230, 240, 250, 260,
270, respectively. Each unit of the cutout portions can include
three cutout segments each segment extending radially from a center
point or center of symmetry. The cutout segments have a three-fold
rotational symmetry, where each cutout segment is rotated 120
degrees from an adjacent cutout segment about a center of symmetry.
Within each zone, all of the units of cutout segments may have an
equal open surface area (i.e., the open surface area is the area
enclosed by the contour of the segments in a contiguous manner) as
well as an equal cut-pattern perimeter length, the length of a
continuous line traced along the shape of the cutout segment.
Across different zones, the units of cutout segments may have
larger surface areas and increased cut-pattern perimeter length in
zones when labeled in the figure with higher zone numbers, e.g.,
the open surface area ranking unit of zone 1<unit of zone
2<unit of zone 3<unit of zone 4<unit of zone 5<unit of
zone 6<unit of zone 7 and the cut-pattern perimeter length
ranking is unit of zone 1<unit of zone 2<unit of zone
3<unit of zone 4<unit of zone 5<unit of zone 6<unit of
zone 7. The patterns of the cutout portions having the three-fold
rotational symmetry about a central point of symmetry (center of
symmetry) as shown can also generally referred to as the "triplex"
pattern or "triplex" cut herein.
[0077] In FIG. 2A-2B, the triplex zones 1-7 are shown as being
arranged sequentially along the longitudinal axis 203 of the tube
having a length LA. The configuration shown provides for a
gradually decreasing uncut surface area coverage along the length
of the tube from the proximal end 201 to the distal end 203,
enabling the tube 200 to have a gradually increasing bending
flexibility from the proximal end 201 to the distal end 203. The 7
zones in FIG. 2B are shown arranged in sequence, i.e., 1 to 7, only
for illustrative purpose. In other embodiments, the zones
containing the units can be arranged in any order along the
longitudinal axis to provide any desired change of bending
flexibility at any point or section along the longitudinal axis.
The tube can be provided with fewer, 1, 2, 3, 4, 5 or 6, or more
zones, 7, 8, 9, 10, 11, 12, 13, 14 or 15 (higher numbers are also
possible, e.g. 20, 30, 40, 50, 60, 70, 80, 90, 100, 200, 300, 400,
500, 600, 700, 800, 900, 1000 to n different zones). The zones,
which have different cutout surface areas as well as different
cut-pattern perimeter lengths, can also be arranged in any order,
e.g., zone 1, zone 6, zone 7, zone 4, zone 5, zone 3, zone 2, in
order to control flexibility of the tube at any point along the
length of the tube.
[0078] As shown in FIGS. 2A-2B, each of zones 1-5 can include two
adjacent rows or bands (as used herein, the term, row or rows is
used interchangeably with the term band or bands) of units of
cutout segments (e.g., bands in zone 1 and bands in zone 2 are
shown as 204, 205 and 206, 207, respectively, FIG. 2A) each
arranged around the circumference of the tube. The rows or bands
may also be referred to as circumferential rows or bands. In a row
or band, the units are distributed in a straight line around the
circumference of the tube. For illustration only, the band
comprising the units of zone 1 and zone 2 are shown with a dotted
line through the center of each band intersecting the center of
symmetry (Cs) for each unit; for zone 1, the dotted lines are 204
and 205, while for zone 2, the dotted line is 206 (FIG. 2A). Other
numbers of bands/rows of units in a zone are also possible,
including, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 70,
80, 90, 100, 200, 300, 400, 500, 1000 up to n bands or rows.
[0079] The spacing between units in a band is shown in FIG. 2A and
is represented as dc, where dc is the distance between the center
of symmetry, Cs, of two adjacent units in the same band (see, e.g.,
204). The spacing, dc, is equal within a single band and may be
constant across the length of the tube in different zones. The
spacing between bands within a zone, e.g., zone 1, zone 2 and zone
3, is shown as d1 (204-205), d2 (206-207) and d3 (208-209);
d1=d2=d3, where the spacing is measured between the lines, 204,
205, 206, 207, 208 and 209, which run through the center of
symmetry, Cs, of the bands within each zone. The spacing between
zones, e.g., zone 1-zone 2, d12 (205-206), zone 2-zone 3, d23
(207-208) and zone 3-zone 4, d34 (209-211); d12=d23=d34, where the
spacing is measured between the lines, 204, 205, 206, 207, 208, 209
and 211. In one embodiment, the spacing between bands within a zone
may be equal to the spacing of two bands between two different
zones, e.g., d1=d2=d3=d12=d23=d34. In other embodiments, the
spacing between bands within a zone may be greater than or less
than the spacing between the bands in two different zones, e.g.,
d1=d2=d3>d12=d23=d34 or d1=d2=d3<d12=d23=d34.
[0080] The overall arrangement of one embodiment of the tube is
shown in FIG. 2B. The boundaries of each zone are shown as follows:
zone 1, 212, 213, zone 2, 214, 215, zone 3, 216, 217, zone 4, 218,
219, zone 5, 221, 222, zone 6, 223, 224 and zone 7, 225, 226. The
boundaries of the zones overlap with each other. The units within
each zone are shown as zone 1, 210, zone 2, 220, zone 3, 230, zone
4, 240, zone 5, 250, zone 6, 260 and zone 7, 270.
[0081] As shown in FIG. 2A-2C, all cutout segments of the units
within a zone can have the same orientation or are in-phase with
respect to the line through the center of symmetry for each row,
204 and 205; compare cutout segments 231-232, 233-234 and 235-236.
The cutout segments in adjacent bands or rows within a zone can
also have the same orientation or are in-phase with respect to the
line through the center of symmetry for each row, 204 and 205;
compare, 231-237 and 235-238. In other words, the corresponding
cutout segments in one unit within a zone are parallel with the
cutout segments in an adjacent unit. The center of symmetry, Cs, of
units within the same zone, but in adjacent bands is shifted by one
unit as shown in FIG. 2C. Between two adjacent zones, e.g., zone 1
and zone 2, the units are shifted around the circumference of the
band such that a straight line, 239, can be drawn between the
center of symmetry for units in the same zone or adjacent zones in
every other band, e.g., 1, 3, 5, 7, etc. bands. The center of
symmetry, Cs, in different bands falls along the same line in every
other band. FIG. 2D--reference lines 281 and 282. In other words,
the center of symmetry of each unit is positioned at the same point
on the circumference of the tube as the center of symmetry of a
second unit in a third, third, fifth, etc. band which is separated
by one band from the first band.
[0082] Depending on the material as well as the structural
requirements in terms of flexibility, the thickness of the tube at
any point can vary, e.g., from about 0.05 mm to 2 mm, e.g., 0.05 mm
to about 1 mm, about 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6
mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, etc. The inner diameter of the
lumen (ID) of the tube portion can vary, e.g., from about 0.1 mm to
about 2 mm, or from about 0.25 mm to about 1 mm, e.g., about 0.2
mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about
0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm, etc. The outer
diameter of the lumen (OD) of the tube can also vary, e.g., from
about 0.2 mm to about 3 mm, e.g., about 0.2 mm, about 0.3 mm, about
0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm,
about 0.9 mm, about 1 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm,
about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8
mm, about 1.9 mm, about 2.0 mm, etc. The thickness of the tube
wall, the inner diameter ID and the outer diameter OD can each be
constant throughout the length of the tube, or vary along the
length of the tube.
[0083] FIGS. 3A, B-9A, B show a close-up image of units from zones
1-7. The units in these figures are shown only as cutout segments,
without overlapping units from other zones as is the case when the
cutout segments are present in the tube (tube wall). FIG. 3A shows
the unit from zone 1 with 3 cutout segments 303, 304 and 305. The
cutout segment maybe formed by two linear portions 309a, 309b,
capped by two curvilinear portions 307 and 311. The curvilinear
portions begin at positions 308 and 310, respectively for cutout
segment 300. In one embodiment, the width of the cutout 306 divided
by 2 equals the radius of the curvilinear portions 307, 311. The
open surface area of the cutout segments 303, 304 and 305 is 300,
301 and 302, respectively. In the embodiment shown, the cutout
segments, 303, 304 and 305 are positioned equally from the center
of symmetry, Cs, 312 by a distance equal to the width 306 divided
by 2. In other words, an imaginary circle 313 may be positioned
between the cutout segments having a radius equal to the width of
the cutout segment 306/2. The cut-pattern perimeter length of the
cutout pattern from zone 1 is shown in FIG. 3B and is the sum of
perimeters of each of the three cutout segments, 314+315+316.
[0084] FIG. 4A shows the unit from zone 2. The cutout zone 407 is
composed of three contiguous cutout segments 400, 401, 402 which
have been merged into a single cutout pattern having an open
surface area of 407. Each cutout segment is composed of two, equal
linear portions, 405a, 405b, and a curvilinear portion 404 starting
at position 403. The center of symmetry, Cs, for the unit is shown
as 406. The linear portions of each cutout segment are connected by
a curvilinear portion 408; specifically, in the embodiment shown,
the linear portion of cutout segment 400, 405b, is connected by a
curvilinear portion 408 to the linear portion 409a of the cutout
segment 401. The radius of curvature of the curvilinear portions
404 and 408 can vary. The width, i.e., the distance between the two
linear portions 405a, 405b can be equal to, less than or greater
than the width between the two linear portions shown in zone 1,
306. The cut-pattern perimeter length of the cutout pattern from
zone 2 is shown in FIG. 4B and is 411.
[0085] FIG. 5A shows the unit from zone 3. The center of symmetry
of the unit is shown as 500 is composed of three contiguous, cutout
segments 501, 502, 503 having an open surface area 514. Each cutout
segment is composed of two linear portions 504a, 504b, and a
curvilinear portion 506, 516 starting at position 507. The open
surface area of the curvilinear portion is shown in cross hatch as
513. The shape of the curvilinear portion 506 can vary and only one
embodiment is shown in the figure. The cutout segments are
connected by a curvilinear portion 512 starting at position 508. As
illustrated in the figure, the two equal, linear portions 504a and
511b are connected by a curvilinear portion 512; the degree of
curvature of the curvilinear portion 512 can vary. The width of the
515 between the two linear portions 504a, 504b can be equal to,
less than or greater than the width of the between the two linear
portions 410 in zone 2, FIG. 4a. The length of the linear portions
504a, 504b is less than, equal to or the greater than the linear
portions in zone 2, 405a, 405b. In the embodiment shown the linear
portions 504a=504b<405a=405b. The cut-pattern perimeter length
of the cutout pattern from zone 3 is shown in FIG. 5B and is
517.
[0086] FIG. 6A shows the unit from zone 4. The center of symmetry,
Cs, of the unit is shown as 600 is composed of three contiguous,
cutout segments 601, 602, 603 having an open surface area 614. Each
cutout segment is composed of two linear portions 604a, 604b, and a
curvilinear portion 606, starting at position 607. The open surface
area of the curvilinear portion is shown in cross hatch as 613. The
shape of the curvilinear portion 606 can vary and only one
embodiment is shown in the figure. The cutout segments are
connected by a curvilinear portion 612 starting at position 608. As
illustrated in the figure, the two equal, linear portions 604a and
604b are connected by a curvilinear portion 612; the degree of
curvature of the curvilinear portion 612 can vary. The width of the
615 between the two linear portions 604a, 604b can be equal to,
less than or greater than the width of the between the two linear
portions 515 in zone 3, FIG. 5a. The length of the linear portions
604a, 604b is less than, equal to or the greater than the linear
portions in zone 3, 505a, 505b. In the embodiment shown the linear
portions 604a=604b<505a=505b. The cut-pattern perimeter length
of the cutout pattern from zone 4 is shown in FIG. 6B and is
616.
[0087] FIG. 7A shows the unit from zone 5. The center of symmetry,
Cs, of the unit is shown as 700 is composed of three contiguous,
cutout segments 701, 702, 703 having an open surface area 714. Each
cutout segment is composed of two linear portions 704a, 704b, and a
curvilinear portion 706, starting at position 707. The open surface
area of the curvilinear portion is shown in cross hatch as 713. The
shape of the curvilinear portion 706 can vary and only one
embodiment is shown in the figure. The cutout segments are
connected by a curvilinear portion 712 starting at position 708. As
illustrated in the figure, the two equal, linear portions 704a and
704b are connected by a curvilinear portion 712; the degree of
curvature of the curvilinear portion 712 can vary. The width of the
715 between the two linear portions 704a, 704b can be equal to,
less than or greater than the width of the between the two linear
portions 615 in zone 4, FIG. 6a. The length of the linear portions
704a, 704b is less than, equal to or the greater than the linear
portions in zone 4, 605a, 605b. In the embodiment shown the linear
portions 704a=704b<605a=605b. The cut-pattern perimeter length
of the cutout pattern from zone 5 is shown in FIG. 7B and is
716.
[0088] FIG. 8A shows the unit from zone 6. The center of symmetry,
Cs, of the unit is shown as 800 is composed of three contiguous,
cutout segments 801, 802, 803 having an open surface area 814. Each
cutout segment is composed of two linear portions 804a, 804b, and a
curvilinear portion 806, starting at position 807. The open surface
area of the curvilinear portion is shown in cross hatch as 813. The
shape of the curvilinear portion 706 can vary and only one
embodiment is shown in the figure. The cutout segments are
connected by a curvilinear portion 812 starting at position 808. As
illustrated in the figure, the two equal, linear portions 804a and
804b are connected by a curvilinear portion 712; the degree of
curvature of the curvilinear portion 712 can vary. The width of the
815 between the two linear portions 804a, 804b can be equal to,
less than or greater than the width of the between the two linear
portions 715 in zone 5, FIG. 7a. The length of the linear portions
804a, 804b is less than, equal to or the greater than the linear
portions in zone 5, 705a, 705b. In the embodiment shown the linear
portions 804a=804b<705a=705b. The cut-pattern perimeter length
of the cutout pattern from zone 6 is shown in FIG. 8B and is
816.
[0089] FIG. 9 shows the unit from zone 7. The center of symmetry,
Cs, of the unit is shown as 900 is composed of three contiguous,
cutout segments 901, 902, 903 having an open surface area 914. Each
cutout segment is composed of two linear portions 904a, 904b, and a
curvilinear portion 906, starting at position 907. The open surface
area of the curvilinear portion is shown as a cross hatch 913. The
shape of the curvilinear portion 906 can vary and only one
embodiment is shown in the figure. The cutout segments are
connected by a curvilinear portion 912 starting at position 908. As
illustrated in the figure, the two equal, linear portions 904a and
911b are connected by a curvilinear portion 912; the degree of
curvature of the curvilinear portion 912 can vary. The width of the
915 between the two linear portions 904a, 904b can be equal to,
less than or greater than the width of the between the two linear
portions 815 in zone 6, FIG. 8a. The length of the linear portions
904a, 904b is less than, equal to or the greater than the linear
portions in zone 6, 805a, 805b. In the embodiment shown the linear
portions 904a=904b<805a=805b. The cut-pattern perimeter length
of the cutout pattern from zone 7 is shown in FIG. 9B and is
916.
[0090] An overview of the transition of the units across zone 1 to
zone 7 is shown in FIGS. 10A-10H. The following characteristics
apply to the dimensions across the zones. The open surface area of
the cutout areas across the different zones rank orders as:
(300+301+302)<407<514<614<714<814<914. The rank
order of the open surface area of the curvilinear portion is:
513<613<713<813<913. The rank of the linear portions
is: 904a=904b<805a=805b<704a=704b<605a=605b<505a=505b.
The rank order of the cut-pattern perimeter lengths is
(314+315+316)<411<517<616<716<816<916. The change
in either open surface area or cut-pattern perimeter length across
multiple zones can be linear, exponential, assume a step-wise or
square wave function and be increasing, decreasing, constant,
continuous or discontinuous.
[0091] Within any one zone, the cutout segments forming a unit may
assume any symmetrical shape about a center of symmetry, Cs. There
may be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or n cutout segments in a
unit. The cutout segments may be continuous or separate. For
example, the cutout segment may form a circle or a symmetrical,
n-sided polygon, such as a hexagon or octagon. Different zones may
have the same or different symmetrical shapes. The geometric rules,
both within a zone as well as across a zone remain the same in
these embodiments as they are for the triplex cutout segments
described above. Specifically, the units are arranged in a band. A
band or row can have 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50,
60, 70, 80, 90, 100, 200, 300, 400, 500, 1000 to n units. The
spacing between units in a band represented as dc, where dc is the
distance between the center of symmetry, Cs, of two adjacent units
in a band, dc, is equal within a single band and may be constant
across the length of the tube in different zones. The spacing
between bands within a zone and across zones may be equal as well.
All cutout segments of the units within a zone can have the same
orientation or are in-phase with respect to the line through the
center of symmetry for each row or band. The cutout segments in
adjacent bands or rows within a zone can also have the same
orientation or are in-phase with respect to the line through the
center of symmetry for each row. The center of symmetry, Cs, of
units within the same zone, but in adjacent bands is shifted.
Between two adjacent zones, the units are shifted around the
circumference of the band such that a straight line can be drawn
between the center of symmetry for units in adjacent zones. The
center of symmetry, Cs, in different bands falls along the same
line in every other band. In other words, the center of symmetry of
each unit is positioned at the same point on the circumference of
the tube as the center of symmetry of a second unit in a third,
third, fifth, etc. band which is separated by one band from the
first band.
[0092] One tube may contain multiple zones. For example, the tube
can be provided with 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
or 15 (higher numbers are also possible, e.g. 20, 30, 40, 50, 60,
70, 80, 90, 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000 to n
different zones). If a tube contains multiple zones, then across
different zones there may be a change in open surface area and
cut-pattern perimeter length. For example, if the cutout segment is
formed in the shape of a hexagon and there are seven zones, a first
zone, a second zone, a third zone, a fourth zone, a fifth zone, a
sixth zone and a seventh zone, then the rank order for the open
surface area and cut-pattern perimeter length is: unit of first
zone <unit of second zone <unit of third zone <unit of
fourth zone <unit of fifth zone <unit sixth zone. If there
are equal number of units per zone, then the rank order applies to
zones as well. The change in either open surface area or
cut-pattern perimeter length across multiple different zones can be
linear, exponential or assume a step-wise or square wave function
and be increasing, decreasing, constant, continuous or
discontinuous.
[0093] In embodiments formed from other cutout segments, e.g.,
circles or n-sided polygons, the width across any uncut portion,
may be varied, i.e., the width may be reduced. This reduction in
width will result in an increase in the open surface area 1004. By
increasing the open surface area, the uncut surface area within
unit in any one zone, the flexibility of that portion composed of
such units with increased open surface area of the cutout segments
will increase.
[0094] The portion of the tube wall remaining after the cutout
segments are removed may vary across the length of the tube and is
inversely correlated with the open surface area of the cutouts.
This inverse correlation is evident from FIGS. 11A-11E which show
the cutout patterns of units, white or unmarked, contrasted with
the remaining uncut surface of the tube, shown in dark color, e.g.,
black, with stippling. The zones are labeled as followed: zone 1,
FIG. 11A, zone 3, FIG. 11B, zone 4, FIG. 11C, zone 5, FIG. 11D and
zone 6, FIG. 11E. As is evident from the figures, the remaining
dark color, e.g., black with stippling or uncut material in the
wall of the tube decreases as the open surface area of the cutout
areas in the unit increases, i.e., the uncut area is inversely
correlated with the cutout surface areas. The flexibility of the
tube may be precisely controlled at any position along the tube by
combining one or more zones at various positions along the length
of the tube. Flexibility of the tube is positively correlated with
the open surface area. In other words, as the open surface area of
a cutout segment increases the flexibility of a zone composed of
units having the larger cutout segments increases. Conversely,
flexibility is inversely correlated with the uncut area; as the
uncut surface area increases, flexibility decreases.
[0095] When zones are combined there may be a continuous transition
in the remaining uncut area as shown in black across the various
zones. The total uncut area at any one point on the tube will
depend on a number of factors, including the number of bands in
each zone and the dimensions of the cutout segments (the open
surface area of a particular unit). If the number of bands in each
zone are constant, then the rank order is for the uncut surface
area, unit of zone 1>unit of zone 2>unit of zone 3>unit of
zone 4>unit of zone 5>unit of zone 6>unit of zone 7 (in
other words, there is a fading of uncut area across zones) and the
rank order of flexibility of the tube is zone 1<zone 2<zone
3<zone 4<zone 5<zone 6<zone 7 (flexibility is
positively correlated with the open surface area and inversely
correlated with the uncut area). The change in flexibility across
multiple different zones can be linear, exponential or assume a
step-wise or square wave function, increasing, decreasing,
constant, discontinuous or continuous.
[0096] One embodiment where the number of bands of units in each
zone are not the same is shown in FIG. 11F.
[0097] A unit in zone 7 is shown in FIG. 12A. The uncut area of the
segment in the unit of zone 7 in FIG. 12 is shown in stripes. In
zone 7, the open surface area 1004 of the cutout segment may be
increased as follows. The center of symmetry for the cutout
segments comprising A, B, C is 1000. The figure shows portions of
three other units from zone 7, 1001, 1002, and 1003. The width
across any uncut portion, 1005, 1006, 1007, 1008, 1009 (shown only
as sample points) may be varied, i.e., the width may be reduced. In
one embodiment, the width 1005, 1006, 1007, 1008, 1009 may be
equal. The width 1005, 1006, 1007, 1008, 1009 may be further
reduced in a uniform or non-uniform manner. This reduction in width
will result in an increase in 1010 with a corresponding increase in
the open surface area 1004. By increasing the open surface area,
the uncut surface area within a unit in zone 7, the flexibility of
that portion composed of such units with increased open surface
area of the cutout segments will increase. FIGS. 12B and 12C show
photomicrographs with a reduction in width of the uncut surface
area or strut wall from 10% and 50%, respectively (the dimensions
are show in micrometers, .mu.M at the bars shown in the figures).
In other embodiments, the reduction in width can be applied to any
zone to increase the open surface area within one zone or across
multiple zones, thereby altering flexibility.
[0098] The cutout segment patterns described here can be applied to
a variety of flexible shaft devices, to replace, supplement or be
combined with braiding and coil composite configurations with a
single thin walled frame. By using different zone patterns along
the shaft length, flexibility can be increased or decreased along
the shaft length, as well as other characteristics of the tube,
such as torque, flexibility, pushability, resistance to axial
compression and stretch, maintaining lumen diameter and kink
resistance.
[0099] The cutout segment patterns described here, as well as other
cut features of the tube can be made by techniques commonly known
in the art, e.g., by a solid-state, femtosecond laser cutting. The
tube portion to be cut can be loaded on a mandrel and the relative
movement between the laser beam and the tube portion can be
controlled by a computer with pre-programmed with instructions to
produce any desired cut patterns. Other material removal techniques
commonly known would also include photo-etching, other laser
platforms and electrical discharge machining (EDM),
[0100] According to embodiments of the present invention, and as
shown in FIG. 13, a tube 1300 can include a section 1310 that
contains one or more zones of the triplex cut patterns described
above, as well as a further section 1320 that contain other cut
patterns, e.g., a spiral cut-pattern 1325. The spiral cut section
may be longer, equal to or shorter than the triplex cut patterns.
The spiral cut section 1320 may include several sub-sections that
may have different spiral parameters, such as cut widths, gaps,
pitches, etc., such that the bending flexibility along the spiral
cut section can vary longitudinally as desired. Additionally, the
spiral cut section may also include interrupted spiral cuts 1321
where the spiral cuts do not form continuous spirals along the tube
wall. The spiral and interrupted spiral cut patterns are also
described in co-pending U.S. application Ser. No. 14/854,242, the
disclosure of which is incorporated herein by reference in its
entirety. Either or both of the spiral cut section and the triplex
section can be encapsulated within an outer jacket and/or an inner
lining. The spiral cut may be made using a laser, e.g.,
femto-second solid-state cutting laser, by removing tube material
from the tube wall. A tube portion fabricated with spiral cuts can
also be viewed as a ribbon or flat coil (made of portions of the
remaining tube wall) wound helically about the longitudinal
axis.
[0101] The tube may have several different spiral-cut patterns,
including continuous and discontinuous. The spiral-cut sections may
provide for a graduated transition in bending flexibility. For
example, the spiral-cut-pattern may have a pitch that changes the
width of the spiral cut ribbon, to increase flexibility in one or
more areas. The pitch of the spiral cuts can be measured by the
distance between points at the same radial position in two adjacent
threads. In one embodiment, the pitch may increase as the spiral
cut progresses from a proximal position to the distal end of the
catheter. In another embodiment, the pitch may decrease as the
spiral cut progresses from a proximal position of the catheter to
the distal end of the catheter. In this case, the distal end of the
catheter may be more flexible. By adjusting the pitch of the spiral
cuts, the pushability, kink resistance, torque, flexibility and
compression resistance of the catheter may be adjusted.
[0102] Spiral-cut sections having different cut patterns may be
distributed along any portion of the length of the tube. The
spiral-cut patterns may be continuous (contiguous) or discontinuous
along the length of the tube. For example, there may be 1, 2, 3, 4,
5, 6, 7, . . . , n spiral-cut sections along the length of the
tube, wherein within each section a constant cut-pattern may be
present but across different sections the cut patterns vary, e.g.,
in terms of pitch. Each section may also contain a variable pitch
pattern within the particular section. Each spiral-cut section may
have a constant pitch, e.g., in the range of from about 0.05 mm to
about 10 mm, e.g., 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm,
0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.5 mm, 2.0 mm, 3.0 mm, 3.5 mm, 4.0
mm, etc. The pitch may also vary within each section. The pitches
for different spiral-cut sections may be same or different.
Alternatively, the tube may have a continuously changing
spiral-cut-pattern along the length of the tube. The orientation or
handedness of spiral-cut sections in the tube may also vary among
spiral-cut sections. Similar to what has been described with
respect to continuous spiral-cuts herein, an interrupted
spiral-cut-pattern can also have a varying pitch that decreases
from a relatively rigid region to a relatively flexible region.
[0103] A tube with triplex cut patterns as described here can be
used as a portion of a medical device, e.g., a catheter (which can
also be referred to as a guide catheter extension). One embodiment,
of the tube which is incorporated into the catheter is shown in
FIG. 14. As schematically shown in FIG. 14A, a catheter 1600 (more
particularly, a guide catheter extension) can include a tube
portion 1610 (a distal tube portion) having multiple zones of
triplex patterns of varying surface area coverage as described
above, a skived (angled entrance port) collar transition section
1620 adjacent the distal tube portion 1610 and having a tapered
edge, the taper having a short end 1621 (closest to the distal tip
1609 of the catheter) and a long end 1625 (furthest away from the
distal tip 1609), a push rod (or wire/rail) 1640 being attached or
joined at the long end 1625. In one embodiment, the transition
section 1620 can be absent, in which case the guide catheter
extension includes the push rod or tube 1640 directly attached to
the tube portion 1610. Further, although it is shown that the
transition section 1620 includes a straight taper 1623 from the
side view, it is understood that various other shapes for the taper
can also be used, e.g., a convex curve, a concave curve, a
curvilinear curve, or other more complex shapes (sinusoidal) (see
e.g., the transition sections shown in FIGS. 14A, 15A, 15B, 15C),
such that a generally slanted lumen opening or mouth is formed
which contains a generally decreased, enclosed circumferential
portion along the longitudinal axis L of the catheter away from the
distal end 1609 (at the short end 1621, the enclosed
circumferential portion is nearly 360 degrees, i.e., a full tube,
while at the long end 1625 the enclosed circumferential portion can
be much smaller, e.g., from 10 degrees to about 50 degrees). The
skived transition section 1620 and the triplex cut-pattern tube
portion 1610 can be made from a same or single tube by laser
cutting creating a single frame or sections. Alternatively, the
tube could be composed of several different frames or sections
situated or laid end-to-end about a common center axis. The push
rod (or wire/rail) 1640, which can be made from a metallic
material, such as stainless steel, can be joined with the skived
transition section 1620 by welding, interlocking or other any other
bonding or fusing method.
[0104] FIG. 14B shows a flat or unrolled view of a portion of a
guide catheter extension 1700. FIG. 14C shows a photo of the
portion of guide catheter extension shown in FIG. 14B. The portion
of guide catheter extension 1700 includes a tube 1710 having a
single triplex pattern (where all units have the same cutout
segments, i.e., the same open surface area and cut-pattern
perimeter length), a skived collar transition section 1720 which
has a generally tapered edge having a short end 1722 and a long end
1725, and an attachment tab 1730 which is welded or bonded together
with a push rod (wire/rail) 1740. As discussed above, all of 1710,
1720, and 1730 can be cut from a single tube by laser. At the short
end 1722 of the transition section 1720, a cut 1715 can be made
from an edge of the transition section 1720 through a closest
triplex unit feature 1712. The width of the cut 1715 can vary. This
cut allows the tube 1710 to expand or open up under pressure during
manufacturing the catheter assembly when the tube is passed over a
mandrel. The pattern of cuts shown in 1723 can vary. In the
embodiment shown in 14B, the pattern forms a square wave pattern
with a descending size, i.e., 1731, 1732, 1733, 1734, 1735. In the
embodiment shown, when rolled into a tube, the two square wave
patterns come together to form a cage like structure which is
flexible, allowing for entire structure to be maneuvered through a
tortuous path or anatomy.
[0105] In one embodiment, transverse cuts made be introduced in the
portion of the pattern showing the square wave pattern in order to
increase flexibility of the section, 1731, 1732, 1733, 1734, 1735.
FIG. 14D. The width of the transverse cuts may also vary depending
on the degree of flexibility required. Although schematically, the
transverse cuts are shown as lines in the figure, other designs may
be used, including a square wave, sinusoidal or meandering
pattern.
[0106] As illustrated in FIGS. 15A-15B, the invention provides for
a tube 1800 (or more particularly, a guide catheter extension) that
includes a distal (full) tube portion 1810, a skived collar
transition section 1820 having a generally tapered edge with
varying degrees of an enclosed circumferential wall portion
(forming a slanted lumen opening) which has a short end 1821 and a
long end 1825, and a push rod (wire/rail) 1830 connected to the
long end 1825 of the skived collar transition section 1820. The
tube portion 1810 of the catheter can include a generally
longitudinal cut-pattern 1880 such that the side wall of the tube
portion 1810 (and the lumen enclosed therein) can be slightly
opened upon an expansion force to facilitate manufacturing of the
inner luminal portion of the tube or insertion of an interventional
device into the slanted lumen opening of the transition section.
Although schematically, the longitudinal cut is shown as a saw
tooth line in the figure, other designs may be used, including a
square wave, sinusoidal zig-zag, square-wave or meandering pattern;
the width of the longitudinal cut can vary and periodicity, i.e., a
repetitive pattern is not required. For example, the cut-pattern
can be a straight line oriented in parallel with the long axis L of
the catheter.
[0107] FIG. 15C shows the catheter 1800 where the tube portion 1810
has cut-pattern 1880. The cut-pattern 1880 can start from the short
end 1821 and can extend either partially or fully along the tube.
As illustrated in FIGS. 15A and 15B, the tube portion 1810 may join
with another tube portion 1850 which does not contain a generally
longitudinal cut pattern. The tube portion 1850, however, can
contain other cut patterns, such as spiral cuts, interrupted spiral
cuts, or triplex cut patterns as described herein.
[0108] FIGS. 15D-15F show a 3D rendering of the skived collar
transition section 1820 and the push/rod 1830. The push rod 1830
may be formed from a separate piece and fused to long end 1825 at
the junction formed between 1832 of the long end 1825 and 1831 of
the push rod 1830 by any bonding method, including, crimping,
swaging, staking. Adhesive bonding, welding, brazing or soldering
may also be used. The design of the joint is shown as a rectangular
opening in the long end 1825. Any shape can be used in a lock and
key framework so that the push rod 1830 could snap fit into the
long end 1825. As shown in FIG. 15F, the profile of the push rod
1830 is flat with respect to the lumen 1833 formed by the long end
1825.
[0109] FIG. 16A shows certain components of a distal portion 1900
of a catheter tube (e.g., a guide catheter extension) according to
an embodiment of the present invention. FIG. 16B shows the distal
portion 1900 as assembled from the components shown in FIG. 16A.
FIG. 16C shows a partial sectional view of the distal portion 1900
as assembled; FIGS. 16D and 16E show partial views of a portion of
the distal portion 1900 as assembled near the distal tip (FIG. 16D)
and a portion of the distal portion 1900 as assembled away from the
distal tip. As shown in FIGS. 16A-16E, the distal portion 1900
having a proximal end 1901 and a distal end 1902, and includes a
skeletal tubular frame 1910 having a single triplex cut pattern, an
outer jacket 1920, an inner liner 1930, and a distal tip 1940
disposed at the distal end 1902. The term skeletal tubular frame
refers to the tube described previously in FIGS. 2 (A)-(D)-13,
inclusive.
[0110] The tip portion has a proximal end 1941 and a distal end
1942, where the distal end 1942 form an inwardly bending curve
forming an opening that has a diameter Dt smaller than that of the
lumen Dc of the catheter tube. The distal tip 1940 near the distal
end 1942 can include a number of cuts 1945 to make the distal tip
more bendable, i.e., smaller "nose cone" like end in order to
minimize trauma of the blood vessel wall when the distal tip is
being advanced into a patient's vasculature. Alternatively, the
distal tip may have a straight tube configuration. The tip portion
1940 can be made from a polymeric material into which a radiopaque
material can be embedded or attached. Radiopaque fillers include
gold, platinum, barium sulfate, bismuth subcarbonate, bismuth
oxychloride, bismuth trioxide and tungsten
(http://www.fostercomp.com/products/radiopaque-additives, retrieved
Nov. 1, 2015).
[0111] The outer jacket 1920 can be made from a polymeric material,
such as polyether block amide (e.g., PEBA.RTM.); the inner liner
1930 can also be made from polymeric material having improved
lubricity, such as PTFE. The jacket can be made from a polymer,
e.g., by enclosing the catheter tube with a co-extruded polymeric
tubular structure of single of multiple layers and heat shrinking
the tubular structure, or coating the catheter tube by dip coating
or spraying. See, e.g., US20040142094. Alternatively, the outer
jacket can be applied by electrospinning using various polymers,
e.g., PTFE to create a fibrous mesh outer layer.
[0112] The polymer jacket material can be formed from nylon,
polyether block amide, PTFE, FEP, PFA, PET, PEEK, etc. Further, the
distal catheter portion (or the entire length of catheter) may be
coated with a hydrophilic polymer coating to enhance increase
lubricity when advancing through the parent guiding catheter or
vascular anatomy. Hydrophilic polymer coatings can include
polyelectrolyte and/or a non-ionic hydrophilic polymer, where the
polyelectrolyte polymer can include poly(acrylamide-co-acrylic
acid) salts, a poly(methacrylamide-co-acrylic acid) salts, a
poly(acrylamide-co-methacrylic acid) salts, etc., and the non-ionic
hydrophilic polymer may be poly(lactams), for example
polyvinylpyrollidone (PVP), polyurethanes, homo- and copolymers of
acrylic and methacrylic acid, polyvinyl alcohol, polyvinylethers,
maleic anhydride based copolymers, polyesters,
hydroxypropylcellulose, heparin, dextran, polypeptides, etc. See
e.g., U.S. Pat. Nos. 6,458,867 and 8,871,869.
[0113] The components shown in FIGS. 16A-16E can be assembled by
heat shrinking the outer jacket 1920 onto the skeletal tube frame
1910, which can fully embed the uncut or remaining portions of the
patterned tube wall, i.e., the skeletal frame. FIGS. 16E and 16F.
The inner liner 1930 can then be adhered with the outer jacket 1920
by heat or other bonding methods (note, the outer jacket is shown
with stippling and the inner lining is shown with cross hatching).
The inner liner may be incorporated in the covering process for the
outer jacket, but the degree to which it is incorporated is
material dependent. As shown in FIG. 16D, the inner liner 1930 can
extend distally beyond the distal end of the skeletal tube 1910 and
directly fused with the body of the distal tip 1940. In FIGS.
16A-16G, the outer jacket and inner liner are used to encapsulate
the skeletal frame 1910. The skeletal frame 1910 is also bound to
the outer most surface of the inner liner 1930, as shown in FIG.
16G. Additionally, dip coating and forming a conformal cover as the
outer surface, allows for capturing or embedding the skeletal frame
(tube) between the layers thereby creating a composite outer jacket
material. The tube itself or the skeletal tube frame can have a
triplex, spiral or a combination of patterns or contain linked
tubular portions as described here. Once fully assembled with the
outer jacket 1920 and inner layer 1930, the interior portion of the
tube 1940, i.e., the lumen of the tube, is then completely enclosed
within the skeletal tube frame 1920, the inner liner 1930 and the
outer jacket 1920. The skeletal frame, i.e., the tube, can also be
used directly without an outer jacket or inner lining. When using
either a coated or uncoated skeletal tube frame, the driving design
factor is maintaining the flexibility of the tube as discussed
previously.
[0114] The guide catheter extension can include a tube portion 2110
having a fully enclosed lumen, a skived collar transition section
2120 adjacent the distal tube portion 2110 and having a generally
tapered edge, and a proximal push rod (wire/rail) 2130 attached to
the transition section 2120. As illustrated in FIG. 17A, a sealer
2150 can be fitted on the distal tube section 2110 and near the
transition section 2120 to reduce the gap between the guide
catheter extension and the surrounding guide catheter.
[0115] The sealer 2150 can take various forms or configurations, as
illustrated in FIGS. 17B-17D. As shown in FIGS. 17B and 17C, the
sealers 2156 and 2157 can be formed with a tubular base 2155 and
2162, respectively, for engaging with the distal tube portion 2110.
The sealer 2155 can include a lateral extension or fin 2154
spirally wound about the tubular base 2152. Alternatively, the
sealer 2157 can include wiping blade surfaces composed of a single
or multiple set of fins or ridges 2164 that are wound
circumferentially about the tubular base 2162 (i.e., perpendicular
to the long axis of sealer). Alternatively, the sealer 2158 can
take the form of a spiral extrusion or filament 2172.
[0116] The sealer, 2156, 2157, 2158, can be made with various
elastic polymeric material, preferably rubbery material having good
lubricity, such as PEBA, PTFE, silicon, polyurethane or other
fluoropolymers. It can be fitted on the distal tube portion of the
inner catheter by physical attachment (e.g., elastic or frictional
engagement), chemical bonding, adhering, welding, gluing, heat
fused or any other bonding method. The inner diameters 2155, 2165,
and 2175 of the respective sealers 2156, 2157, and 2158 can be
substantially the same as, or slightly smaller than, the outer
diameter of the distal tube portion of the guide catheter
extension. The fins and the base in sealers 2154, 2164 and 2152,
2162, respectively, can be made from the same material, or
different materials. The heights of the fins of sealers 2154, 2164,
and the diameter of the spiral wire 2172 can be selected according
to the inner diameter of the guide catheter. The outer diameter of
the sealer(s) (including the height of the fin(s) in 2154/2164, and
the diameter of the spiral wire 2172) can be substantially the same
as the inner diameter of the lumen of the guide catheter. The
thickness of the fins can be selected such that the fins have
sufficient pliability to allow the guide catheter extension to move
axially within the guide catheter without significantly hampering
its maneuverability or tactile feedback to the physician, while
remaining sufficient obstructive to impede flow or back flow of
bodily fluids caused by the suction or aspiration on the outer
surface of the catheter body.
[0117] The guide catheter extension can have a flare or flange
2452. The flare or flange can be used to close or reduce the gap
between the guide catheter extension and an enclosing guide
catheter. As illustrated in FIGS. 18A and 18B, a guide catheter
extension 2500 can include a tube 2410 having a proximal end 2411,
which is connected to a push rod 2430. At the proximal end 2411
there is a radially outwardly extending flare 2450, that may be
substantially perpendicular to the long axis of the tube, which has
a greater diameter than the outer diameter of the tube portion
2410, allowing a seal by a bib 2412 to form between the guide
catheter extension and the guide catheter 2490. In this embodiment,
the tube terminates and then transitions directly to the push rod
2430 without a transition through a skive.
[0118] Alternatively, the guide catheter 2501 can include a distal
tube portion 2410, a skived collar transition section 2420 adjacent
the distal tube portion 2410 and a generally tapered edge having a
short end 2421 and a long end 2423, and a push rod 2430 connected
to the long end 2423 of the transition section. A flare or flange
2452 extends radially outwardly from the lumen opening formed by
the tapered edge, and has a greater diameter than the outer
diameter of the tube portion 2410. Thus, like the sealers described
in connection with FIGS. 17A-17D, and the flare or flange described
in connection with FIG. 18A, the flare or flange can substantially
close or seal the gap 2488 by a bib 2435 formed between the guide
catheter 2490 and the tube 2410, which may be covered by an outer
jacket. This type of construction enables the guide catheter 2490
and the guide catheter extension 2500, 2501 to be used to inject
contrast media into a target site in the patient's vasculature
without leakage from the distal end of the guide catheter, i.e.,
the end closest to the push rod 2430. The flare together with the
bib can also be used to facilitate smooth insertion of an
interventional device, such as a balloon catheter or a stent.
[0119] Like the sealer described previously, the flares described
in connection with FIGS. 17A-17B can be made from an elastic
polymeric material, preferably rubbery material with good
lubricity, such as PEBA, PTFE, silicon or other fluoropolymers. The
thickness of the flare can be selected to ensure the flares have
sufficient pliability to allow the guide catheter extension to move
axially within the guide catheter without significantly hampering
its maneuverability. For example, the thickness of the flare can be
about 0.1 mm to about 1 mm, or about 0.2 mm to about 0.5 mm. The
flares can be made as a separate piece and adhered to the proximal
end 2411 (in FIG. 18A) or the lumen opening of the transition
section 2420 (in FIG. 18B), or made as an extension of an inner
lining or outer jacket of the catheter extension 2400a or
2400b.
[0120] In one embodiment, and as illustrated by FIG. 19, the
invention provides for a guide catheter extension 2500 that
includes a first tube portion 2512, a second tube portion 2514 that
has a gradually decreased diameter distally, and a third tube
portion 2516 which is at the distal end of the guide catheter
extension and that can include a radiopaque tip 2517. The narrowing
in diameter of the first and second tube portion may be produced by
shape training of the nitinol tube using standard heating
technology (see
http://www-personal.umich.edu/.about.btrease/share/SMA-Shape-Training-Tut-
orial.pdf, retrieved Nov. 1, 2015). The skived collar transition
section 2520 is disposed adjacent the first tube portion 2512. The
transition section 2520 has a generally tapered edge having a short
end 2521 and a long end 2523, and a flange 2550 extends radially
outwardly from the slanted lumen opening formed by the tapered
edge. A push rod 2530 is attached to the transition section
2520.
[0121] To use as an injection or aspiration system, both the guide
catheter and the distal tube portion of the guide catheter
extension should have a tube wall impermeable to fluid. Such
impermeable tube wall can be made of a solid tube (made from a
metal, a polymer, optionally with embedded braid or other
reinforcing material), or made from a tube having spiral-cut or
other cut patterns (such as the triplex cut patterns described
herein) and sealed with a fluid-impermeable jacket, e.g., PEBA,
nylon, PTFE, silicon or other material. The invention also provides
for an aspiration system including a guide (or outer) catheter
having a guide catheter lumen, an inner catheter (e.g., a guide
catheter extension) movable within the inner guide catheter lumen,
and the outer edge of a sealing member on the inner catheter. The
inner catheter can be a guide catheter extension which can
generally take the form of those described herein.
[0122] Each of the first tube portion 2512 and the second tube
portion 2514 can be made from a metal or metal alloy (such as
stainless steel (spring steel) or nitinol), or a braid or coil
supported polymer material. The second tube portion 1514 can
include a spiral cut-pattern 2515, and the pitch of the spiral cut
can be gradually decreased distally. An outer jacket and an inner
lining can be coated onto the spiral-cut section to seal off the
openings of the spiral cuts. The third tube portion 2516 can be
made from a material or construction more flexible or pliable than
the material or construction for the first and the second tube
portions 2512 and 2514. For example, the third tube portion 2516
can be formed from a polymeric material without a wire or braid
support. In general, the flexibility of the three tube portions
2512, 2514, and 2516 decreases distally. The flare and the bib
together with the distally decreased lumen diameter allows easy
insertion of variable-sized (diameter) interventional devices, such
as micro-catheters, balloon catheters, and stents, into the lumen
of the guide catheter extension 2500.
[0123] The guide catheter extension can be assembled together with
a handle for pushing or torqueing. FIG. 20 depicts one embodiment
of the non-functional catheter hub, holding tap or maneuvering hub
which can provide aid in torqueing the device once inside the
anatomy, 2608. The push rod 2607 is fused to the long end 2600. The
lumen 2604 runs through the guide catheter extension 2601. In the
embodiment shown, there are two sealers configurations 2603 and
2062.
[0124] The scope of the present invention is not limited by what
has been specifically shown and described hereinabove. Those
skilled in the art will recognize that there are suitable
alternatives to the depicted examples of configurations,
constructions, and dimensions, and materials. The citation and
discussion of any references in the application is provided merely
to clarify the description of the present invention and is not an
admission that any reference is prior art to the invention
described herein. All references cited and discussed in this
specification are incorporated herein by reference in their
entirety. While certain embodiments of the present invention have
been shown and described, it will be obvious to those skilled in
the art that changes and modifications may be made without
departing from the spirit and scope of the invention. The matter
set forth in the foregoing description and accompanying drawings is
offered by way of illustration only and not as a limitation.
* * * * *
References