U.S. patent application number 13/372183 was filed with the patent office on 2012-08-23 for balloon catheter with elastic segment.
This patent application is currently assigned to ABBOTT LABORATORIES VASCULAR ENTERPRISES LIMITED. Invention is credited to Andrew Jeffrey, Michael Jetter, Stefan Leuthold, Gunter Lorenz, Christine Pagel, Doreen Seeger, Boris Warnack.
Application Number | 20120215167 13/372183 |
Document ID | / |
Family ID | 37693437 |
Filed Date | 2012-08-23 |
United States Patent
Application |
20120215167 |
Kind Code |
A1 |
Pagel; Christine ; et
al. |
August 23, 2012 |
BALLOON CATHETER WITH ELASTIC SEGMENT
Abstract
The present invention relates to a catheter comprising an outer
tube; an inner tube; and a balloon fixed at its proximal sleeve to
the outer tube and at its distal sleeve to the inner tube, wherein
the inner tube comprises an elastic segment.
Inventors: |
Pagel; Christine; (Galway,
IE) ; Seeger; Doreen; (Waldachtal-Tumlingen, DE)
; Jeffrey; Andrew; (Tuebingen, DE) ; Warnack;
Boris; (Mountain View, CA) ; Leuthold; Stefan;
(Zurich, CH) ; Jetter; Michael; (Thayngen, CH)
; Lorenz; Gunter; (Tubingen, DE) |
Assignee: |
ABBOTT LABORATORIES VASCULAR
ENTERPRISES LIMITED
Dublin
IE
|
Family ID: |
37693437 |
Appl. No.: |
13/372183 |
Filed: |
February 13, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12093589 |
Sep 17, 2008 |
8114048 |
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PCT/EP2006/010903 |
Nov 14, 2006 |
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13372183 |
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60736434 |
Nov 14, 2005 |
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Current U.S.
Class: |
604/103.11 |
Current CPC
Class: |
A61M 25/104 20130101;
A61M 25/0054 20130101; A61F 2/958 20130101; A61F 2002/9583
20130101; A61M 2025/1068 20130101; A61L 29/06 20130101; A61M 25/10
20130101 |
Class at
Publication: |
604/103.11 |
International
Class: |
A61M 25/10 20060101
A61M025/10 |
Claims
1. A catheter comprising: an outer tube; an inner tube; and a
balloon fixed at its proximal sleeve to the outer tube and at its
distal sleeve to the inner tube, the inner tube comprising an
elastic segment.
2. The catheter according to claim 1, wherein said elastic segment
is positioned within the balloon.
3. The catheter according to claim 1, wherein the elastic segment
is positioned under the proximal sleeve.
4. The catheter according to claim 1, wherein the elastic segment
is positioned proximal of the proximal sleeve.
5. The catheter according to claim 1, wherein the elastic segment
is an elastic tube integrated into the inner tube, the elastic tube
being formed of a material having a lower e-modulus than the
materials the balloon and the inner tube are formed of.
6. The catheter according to claim 1, wherein the elastic segment
includes an elastic inner body and a surrounding sleeve abutting at
one end to a stop portion of the elastic inner body.
7. The catheter according to claim 1, wherein the elastic segment
includes an elastic member and a coil surrounding the inner elastic
element.
8. The catheter according to claim 1, wherein the elastic segment
includes an elastic member and a wire arrangement with a wire
having a stop member, the wire being fixed to the inner tube, said
stop member co-operating with at least one marker, of the inner
tube.
9. The catheter according to claim 1, wherein the elastic segment
comprises an elastic member and at least one tube being positioned
on the elastic inner element.
10. The catheter according to claim 1, wherein the elastic segment
comprises an elastic member and a tube being positioned on the
elastic inner element said tube being positioned between markers,
said markers, being positioned on the inner tube.
11. The catheter according to claim 1, wherein at least a part of
the elastic segment is treated with thermal transfer annealing.
12. The catheter according to claim 1, wherein the elastic segment
further comprises a elastic member and a telescopic tube.
13. An elastic segment for a catheter comprising an outer tube; an
inner tube; and a balloon fixed at its proximal sleeve to the outer
tube and at its distal sleeve to the inner tube, wherein the
elastic segment is part of the inner tube.
14. The elastic segment according to claim 13, wherein said elastic
segment is positioned within the balloon.
15. The elastic segment according to claim 13, wherein said elastic
segment is positioned under the proximal sleeve.
16. The elastic segment according to claim 13, wherein said elastic
segment is positioned proximal of the proximal sleeve.
17. The elastic segment according to claim 13, wherein said elastic
segment is an elastic tube integrated into the inner tube, the
elastic tube being formed of a material having a lower e-modulus
than the materials the balloon and the inner tube are formed
of.
18. The elastic segment according to claim 13, wherein said elastic
segment includes an elastic inner body and a surrounding sleeve
abutting at one end to a stop portion of the elastic inner
body.
19. The elastic segment according to claim 13, wherein said elastic
segment includes an elastic member and a coil surrounding the inner
elastic element.
20. The elastic segment according to claim 13, wherein said elastic
segment includes an elastic member and a wire arrangement with a
wire having a stop member, the wire being fixed to the inner tube,
said stop member co-operating with at least one marker, of the
inner tube.
21. The elastic segment according to claim 13, wherein the elastic
segment comprises an elastic member and a tube being positioned on
the elastic inner element.
22. The elastic segment according to claim 13, wherein the elastic
segment comprises an elastic member and a tube being positioned on
the elastic inner element said tube being positioned between
markers, said markers being positioned on the inner tube.
23. The elastic shaft segment according to claim 13, wherein at
least a part of the elastic segment is treated with thermal
transfer annealing.
24. The elastic shaft segment according to claim 13, comprising an
elastic member and a telescopic tube.
25. A catheter comprising: an inflatable balloon body having: a
proximal fixing portion fixed to a proximal end of a catheter
shaft, and a distal fixing portion fixed to a distal end of the
catheter shaft; said catheter shaft including: an inflation lumen
connected to the interior of said balloon body and a guide wire
lumen including a proximal tube portion ending at least
approximately at the proximal fixing portion and an intermediate
tube portion extending from the proximal fixing portion to the
distal fixing portion through the interior of the balloon body, and
a tip portion extending at least to the distal fixing portion,
characterized in that a hollow marker shaft is provided having a
proximal end with an outer circumferential wall and a distal end
with an outer circumferential wall; that the outer circumferential
wall of the proximal end is fixed to an inner wall portion of said
proximal tube portion; that the outer circumferential wall of the
distal end is fixed to an inner wall portion of the distal fixing
portion; and that the intermediate tube portion and the tip portion
are combined to a separate shaft member loosely fitted into said
hollow marker shaft and having a proximal end being fixed to a
proximal inner wall portion of said marker shaft.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 12/093,589, filed Sep. 17, 2008, now U.S. Pat. No. 8,114,048,
which is a U.S. Nationalization of PCT International Application
No. PCT/EP2006/010903, filed Nov. 14, 2006, which claims priority
to U.S. Provisional Application Ser. No. 60/736,434, filed Nov. 14,
2005, the contents of each of the foregoing applications are
incorporated herein, in their entirety, by this reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a catheter (1) comprising
an outer tube (2); an inner tube (3); and a balloon (4) fixed at
its proximal sleeve (5) to the outer tube (2) and at its distal
sleeve (6) to the inner tube (3). More specifically, the present
invention relates to a catheter with an inner tube (3) comprising
an elastic segment (7).
[0004] 2. Background Information
[0005] Non-invasive procedures such as percutaneous transluminal
angioplasty (PTA), percutaneous transluminal coronary angioplasty
(PTCA), stent delivery and deployment, predilatation before stent
placement, postdilatation after stent placement, radiation
treatment, delivery of a drug at a lesion site and other procedures
are used in the treatment of intravascular disease. These therapies
are well known in the art and usually utilize a balloon catheter
pushed over a guide wire. After a guiding catheter is placed into
the patient's main vessel, a guide wire is advanced in the guide
catheter and beyond the distal end of the guide catheter. The
balloon catheter is then advanced over the guide wire until it
reaches the treatment site at the lesion or stenosis. The balloon
is inflated to compress the lesion site and dilate the previous
narrowed lesion or stenosis site. If the balloon carried a stent
and/or drug, the stent and/or drug is delivered at the site when
the balloon is inflated. Likewise, further therapies may also use a
balloon catheter for the treatment of the lesion site. Balloon
catheters are well known in the art. U.S. Pat. No. 504,704(5) and
U.S. Pat. No. 515,659(4) for example describe general concepts of
angioplasty catheters.
[0006] In PTCA applications, the balloon is usually inflated to
pressures higher than the nominal pressure but less than rated
burst pressure in order to achieve a slight overdilatation. When
the catheter is inflated to pressures higher than the nominal
pressure the balloon starts to grow in diameter, but also in
length. As the inner tube usually does not grow to the same extend
as does the balloon, the inflated balloon tends to bend in one
direction. This behaviour is also known as "banana shape effect".
On the other hand, once the balloon is inflated and grows, the
inner tube being attached to the distal sleeve of the balloon is
also forced to stretch itself in the longitudinal direction. This
longitudinal growth of the inner tube results in an irreversible
and visible over-expansion of the material and results in an
"S-shaped" inner tube after deflation of the balloon of the
catheter.
SUMMARY OF THE INVENTION
[0007] It is therefore an object of the present invention to
provide a catheter that does not show a banana-shaped balloon or a
s-shaped inner tube. It is further an object of the invention to
provide a catheter that is able to prevent the inner tube from
being over-expanded upon pressurization of the balloon of the
catheter. It is a further object of the present invention to
provide an elastic segment that can be integrated into the inner
tube of a catheter or constitutes the inner tube of a catheter and
allows prevention of banana- or s-shape formation of the balloon or
the inner tube during and after inflation of the balloon.
[0008] The invention is directed to a catheter (1) comprising an
outer tube (2) an inner tube (3) or guide wire tube (3); and a
balloon (4) fixed at its proximal sleeve (5) to the outer tube (2)
and at its distal sleeve (6) to the inner tube (3), being
characterized in that the inner tube (3) comprises an elastic
segment (7). The present invention is also directed to an elastic
segment of a catheter.
[0009] By the provision of an elastic segment that is integrated
into the inner tube, the longitudinal growth of the inner tube can
be compensated. The elastic segment absorbs the stretching and
prevents therewith the inner tube from an over-expansion. When the
balloon is deflated, the elastic segment degenerates or contracts
itself and thus, the entire inner tube degenerates or shrinks back
to its original length and shape.
[0010] It is further an object of the present invention to provide
a balloon catheter that has an elastic segment but still provides
enough push to track the catheter across tight lesions in the
vessel. Therefore, the elastic segment preferably shows higher
elastic behaviour under pulling forces than under pushing forces
and is preferably only elastic in longitudinal direction.
[0011] Further advantages and features and embodiments of the
present application become apparent from the following detailed
description and the description of the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIGS. 1A and 1B are schematically simplified side views of a
catheter according to a first and second embodiment of the
invention.
[0013] FIG. 2A is a schematically simplified side view of a third
embodiment according to the present invention, and
[0014] FIGS. AB, 2C, 2D, and 2E illustrate possible cross sections
taken along line A-A of FIG. 2A.
[0015] FIG. 3 is a schematically simplified side view of a further
embodiment according to the present invention.
[0016] FIGS. 4A and 4B are stress-strain-diagrams of suitable
materials for balloon and elastic member according to the present
invention FIGS. 5 and 8 to 15 are schematically simplified side
views of alternatives of a catheter according to the present
invention.
[0017] FIGS. 6A, 6B and 7 are schematically simplified side views
of alternatives of elastic segments to be used with a catheter
according to the invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0018] The catheter and the elastic segment of the present
invention have several embodiments described hereinbelow and partly
illustrated in the FIGS. 1 through 14. In accordance with the
present invention a catheter (1) is provided comprising an outer
tube (2); an inner tube (3); and a balloon (4) fixed at its
proximal sleeve (5) to the outer tube (2) and at its distal sleeve
(6) to the inner tube (3). The catheter further includes an inner
tube (3) comprising an elastic segment (7). Further, in accordance
with the present invention an elastic segment is provided that is
integrated into the inner tube (3) of a catheter or constitutes the
inner tube of a catheter according to the present invention.
[0019] Reference will now be made in detail to the present
preferred embodiments of the invention.
[0020] FIGS. 1A and 1B show two embodiments of a distal portion of
a catheter (1) comprising an outer tube (2) and an inner tube (3)
or also called guide wire tube (3) that is concentrically
positioned within the outer tube 2. A balloon (4) comprises a
proximal sleeve (5) that is attached to the outer tube 2. Moreover,
the balloon (4) comprises a distal sleeve (6) that is attached to
the inner tube 3. The balloon (4) furthermore comprises a balloon
body 4A defining an interior chamber 4B that can be inflated and
deflated by a pressurizing fluid. FIGS. 1 and 2 show the inflated
condition of balloon 4. This type of catheter is also referred to
as a catheter in a coaxial configuration, i.e. at least in a
portion of the catheter proximal of the proximal balloon sleeve,
the outer tube is concentrically disposed over the guide wire tube
(3) or inner tube (3), the annular space between inner and outer
tube creating the inflation lumen, which is in fluid communication
with the balloon chamber.
[0021] In a further embodiment as shown in FIG. 2A the catheter
comprises a catheter shaft (21) in side-by-side lumen
configuration, also referred to as dual-lumen catheter shaft. In
this configuration the inflation lumen and the guide wire lumen are
arranged in a parallel manner to each other, the inflation lumen
does not fully surround the guide wire lumen in circumferential
direction. Possible cross sections of the catheter shaft
construction taken along line A-A in FIG. 2A are shown in FIGS. 2B;
2C, 2D; and 2E. A balloon (4) comprises a proximal sleeve (5) that
is attached to the distal end region of the dual-lumen catheter
shaft. The distal sleeve (6) of the balloon (4) is attached to the
distal region of an inner tube (3), whereby the inner tube (3)
itself is in fluid connection to the guide wire lumen. The balloon
(4) furthermore comprises a balloon body (4A) defining an interior
chamber (4B) that can be inflated and deflated by a pressurizing
fluid.
[0022] In accordance with the present invention, the catheter shaft
can also be constructed by a combination of the coaxial shaft
design and the side-by-side lumen design. In a preferred embodiment
as depicted in FIG. 3, the shaft comprises a proximal portion of
the catheter shaft that is configured to have a side-by-side lumen
design (24), a transition region (22), and a distal portion
proximal of the balloon that is configured to have a coaxial shaft
design (23). Such a catheter design is exemplarily described in
U.S. Pat. No. 5,370,615 to Johnson.
[0023] In accordance with the present invention all embodiments as
depicted in FIGS. 1 to 3 comprise an elastic segment (7) that is a
tubular component being integrated in the inner tube (3). The
embodiment of FIG. 1A shows the elastic segment (7) being
positioned in a transitional region between the proximal sleeve (5)
and the proximal side of the balloon (4). This depiction is
representative of the before-described positioning as well as the
positioning underneath the proximal sleeve (5) or at the proximal
side of the proximal sleeve (5) of the balloon 4. In turn, FIGS.
1B, 2 and 3 show embodiments according to which the elastic segment
(7) is positioned within the interior chamber (4B) of the balloon
(4). The elastic shaft segment can have different sizes and lengths
in various embodiments. For sake of illustration but not
limitation, the elastic shaft segments in FIGS. 1A, 1B, 2 and 3 are
indicated as small portions of the inner tube. The elastic segment
however can also extend along the whole length of the balloon or a
portion thereof. The elastic segment can also constitute the whole
inner tube. In case of catheter designs, which have a coaxial
catheter construction in their distal shaft portion, the elastic
shaft segment can extend from any position distal of the distal
balloon sleeve, underneath the balloon sleeve or proximal of the
distal balloon sleeve to any position distal, underneath or
proximal of the proximal balloon sleeve.
[0024] In a first preferred embodiment, the elastic segment (7) is
formed of an elastic tubular member (12) integrated into the inner
tube (3). The elastic member is more elastic than the balloon. This
is achieved by the use of materials for the elastic member having a
lower E-modulus than the materials of the balloon (4).
[0025] Preferred material characteristics are shown in FIGS. 4A and
B, which illustrate stress-strain-diagrams of suitable material
combinations for balloon and elastic member. The stress (.sigma.)
is plotted on the Y-axis, while the strain (.epsilon.) is plotted
on the x-axis. Curve 25 indicates the stress-strain-diagram of the
balloon material, while curve 26 indicates the
stress-strain-diagram of the elastic member. During inflation of
the balloon, stress preferably stays in the elastic, i.e. linear
region of both curves. Preferred working ranges (W) are indicated
by shaded boxes.
[0026] Materials suitable for forming the elastic member comprise
soft polyesterether block copolymers, e.g. PEBAX 3533, PEBAX 2533,
PEBAX 4033, PEBAX 5533, PEBAX 6333, polyurethanes, Silicones, PVC,
EVA, Polyethylene, TPE, as well as any polymer classified as having
a A-shore hardness, like soft thermoplastic elastomeres. Suitable
materials to form the balloon comprise Polyamides (e.g. Nylon 11,
Nylon 12, Nylon 6,6), Polyurethanes, Polyetherblockamides (e.g.
PEBAX, ELY), Hytrel), PET, and blends and compositions thereof. The
inner and outer tube of the catheter can be formed of materials
comprising Polyamides (e.g. Nylon 11, Nylon 12, Nylon 6,6, Nylon
7/11, Nylon 11/12), Polyurethanes (e.g. Tecoflex, Pellethene,
Bionate, Corethane, Elasteon), Polyethylenes (e.g. PET, PBT, PVDF,
ETFE, Teflon), Polyolefins (e.g. HDPE, PE, LDPE, LLDPE,
polypropylene), Polyimides, Polyetherblockamides, (e.g. ELY,
PEBAX), Polycarbonate blockamides (Ubesta), and blends,
compositions or multilayers thereof.
[0027] In one embodiment of the present invention, the elastic
tubular member has the same dimensions (i.e. diameter and wall
thickness) as does the inner tube. In another embodiment of the
preset invention, the elastic tube member has a varying wall
thicknesses in order to provide varying flexibility and elasticity
to the member. An example is depicted in FIG. 5. In this embodiment
the elastic tube member (7, 12) extends from the distal balloon
sleeve to the proximal balloon sleeve. The elastic tubular member
is tapered from its proximal end to its distal end, e.g., the
elastic tubular member is of conical shape. In this example
additionally to the provision of an elastic segment, there is also
provided more flexibility to the catheter in its distal region.
[0028] FIGS. 6A and 6B are side views of two options of a further
embodiment of the elastic segment (7). Each figure shows a
longitudinal cross sectional view of the tubular elastic segment
(7) being integrated into the inner tube (3) of the catheter (1).
The tubular elastic segment comprises an inner elastic body (8)
having a main body portion (9) and a stop portion (10). Both ends
of the inner elastic body (8) are fixedly attached to the inner
tube (3). The main body portion (9) is surrounded by a sleeve (11)
that can be fixedly attached to the inner tube (3) at one end, the
other end is loosely abutting the stop portion (10) in order to
limit shrinking of the elastic main body portion while for example
pushing the balloon catheter through a tight stenosis.
[0029] A further alternative embodiment of the present invention is
shown in FIG. 7. In this alternative embodiment the elastic segment
(7) comprises an elastic element (12) or member (12) that is
surrounded or covered by a coil (13) (3) that is wound around at
least a portion of the elastic element (12) in a blocked manner so
that it is able to restrict the retraction movement of the elastic
body (12) (2) upon deflation of the balloon. The coil may cover a
portion of the elastic member, the elastic member in its entirety
or the coil may also cover portions of the inner tube proximal
and/or distal of the elastic member.
[0030] In a further alternative embodiment, the present invention
the elastic segment (7) comprises an elastic member (12) and a wire
arrangement (14) as depicted in FIG. 8. The wire arrangement
comprises a wire (14A) being fixed to the inner tube (3). Wire
(14A) is provided with a stop member (15) cooperating with one of
markers (15) and (16) positioned on the inner tube (3) in order to
limit the contraction movement of wire 14A upon deflation of the
balloon 4.
[0031] In a further alternative embodiment of the present invention
the elastic segment (7) comprises an elastic member (12) and a
sleeve (18) covering at least a portion of the elastic member
(12).
[0032] One embodiment is illustrated in FIG. 9 showing the distal
portion of a catheter (1) comprising an elastic segment (7) and a
sleeve (18) positioned directly on the elastic segment (7). When
contracting, the elastic segment (7) is slightly thickened so that,
by means of frictional forces, sleeve (18) can restrict the
contraction movement of the elastic segment (7).
[0033] Another embodiment is depicted in FIG. 10. In FIG. 10 there
is shown the distal portion of a catheter (1) having an arrangement
of a sleeve (18) being positioned on the elastic segment between
markers (16) and (17) in order to limit the retraction movement of
the elastic segment (7).
[0034] In a further embodiment, rigid shrink tubes made from
material with a high E-modulus are mounted on the elastic tube.
This way, an elastic segment is created, which has areas of
different flexibility and elasticity. FIG. 11 shows the distal
portion of a catheter according to the present invention. The
elastic member (12) extends along the whole length of the balloon
(4). Distal of the distal marker and proximal of the proximal
marker a shrink tube (31, 32) is mounted onto the elastic member
(12). It is obvious to the person skilled in the art that one or
more shrink tube can cover at least one portion but also several
portions of the elastic member.
[0035] In a further embodiment of the present invention the elastic
segment (7) comprises an elastic member and a telescopic inner
tube.
[0036] One embodiment according to the present invention is
exemplarily shown in FIG. 15. The catheter (1) comprises an outer
tube (2) an inner tube (3) and a balloon (4) fixed at its proximal
sleeve (5) to the outer tube (2) and at its distal sleeve to the
inner tube (3). The inner tube (3) comprises an elastic member (12)
that in this example extends from underneath the distal balloon
sleeve to a region juxtaposed to the proximal balloon sleeve.
However, it is obvious to the person skilled in the art that the
elastic member can vary in size and length.
[0037] The proximal balloon sleeve is attached to a distal region
of the inner tube comprising the elastic member. The elastic
segment (7) further comprises a separate shaft member or telescopic
inner tube (60) made from material having a lower E-modulus than
the material of the elastic member. The separate shaft member (60)
is inserted into the inner tube (3) to result in a sliding fit. The
separate shaft member (60) is fixedly attached at an attachment
site (50) at its proximal end to inner tube (3). The region distal
of the proximal attachment side is not fixed to the inner tube nor
to the balloon sleeve. By the provision of this telescopic element,
the distal balloon end can slide on the separate shaft member (60)
upon balloon inflation and deflation, while the separate shaft
member will provide push to the catheter tip portion.
[0038] In a further embodiment the inner tube consists out of two
superposed tubes, a hollow marker shaft tube comprising an elastic
member or consisting of an elastic member and a separate distal
shaft member tube. The hollow marker shaft tube is fixed at one end
to a proximal tube portion of the guide wire lumen tube and at the
other end to the distal balloon sleeve so that said hollow marker
shaft tube extends within the interior of the balloon body.
[0039] The separate shaft member tube is placed into said hollow
marker shaft tube to result in a sliding fit. The proximal end of
said separate shaft member is disposed adjacent to the proximal end
of the balloon body and is fixed to a proximal inner wall portion
of the marker shaft tube, whilst the rest of said separate shaft
member is only guided within the hollow marker shaft tube but is
not fixed thereto at any other place.
[0040] Upon inflation of the balloon, the balloon and the marker
shaft tube both elongate, whilst the separate shaft member does not
undergo any elongation. This way, the distal end of the balloon end
can slide to the distal end of the separate shaft member thus
avoiding formation of the banana-shape of the balloon during
inflation as well as eliminating the S-shape formation of the inner
tube upon balloon deflation.
[0041] FIG. (12) shows the distal portion of a catheter (1)
according to the present invention.
[0042] The balloon catheter (1) comprises an inflatable balloon
body (102) having a proximal balloon sleeve (103) that is fixed to
a proximal end (104) of a catheter shaft (105).
[0043] A distal fixing portion (106) of the balloon body (102) is
fixed to a distal end region (109) of the inner tube (3).
[0044] The catheter shaft (105) includes an inflation lumen (107)
that is connected to the interior (108) of the balloon body
(102).
[0045] Furthermore, the catheter shaft (105) includes a guide wire
lumen (110) that is the interior of a proximal tube portion (111),
proximal tube portion (111) ending at least approximately (in the
present case exactly) at the proximal balloon sleeve (103) of the
balloon body (102).
[0046] The guide wire lumen (110) extends furthermore into an
intermediate tube portion (112) that extends within the interior
(108) of the balloon body (102) from the proximal balloon sleeve
(103) to the distal fixing portion (106) of the balloon body
(102).
[0047] Finally, the guide wire lumen (110) extends into a tip
portion (120) that extends at least to the distal fixing portion
(106). According to the preferred embodiment of FIG. 12, the tip
portion (120) extends beyond said distal fixing portion (106), as
can be seen from FIG. 12.
[0048] The balloon catheter (1) furthermore comprises a hollow
marker shaft tube (113) that has a proximal end (114) with an outer
circumferential wall (115) and a distal end (116) with an outer
circumferential wall (117).
[0049] The outer circumferential wall (115) of the proximal end
(114) is fixed to an inner wall portion (118) of the proximal tube
portion (111). The outer circumferential wall (117) of the distal
end (116) of the marker shaft tube is fixed to an inner wall
portion (119) of the distal fixing portion (106) of the balloon.
The fixation is preferably a weld.
[0050] The marker shaft tube (113) carries two marker bands (124)
and (125) as can be seen from FIG. 12.
[0051] The separate shaft member (121) is loosely fitted into the
hollow marker shaft tube (113) and has a proximal end (122) that is
fixed to a proximal inner wall portion (123) of said marker shaft
tube (113). In one embodiment the separate shaft member (121) is
formed from one tube. In another preferred embodiment, the separate
shaft member (121) is formed from two tube portions tightly secured
together, a proximal intermediate tube portion (112) and a distal
tip portion (120).
[0052] FIG. 13 shows a second embodiment of a balloon catheter that
generally corresponds to the embodiment of FIG. 12 so that all
parts of said second embodiment are designated with the same
reference numerals that were used for the description of FIG.
12.
[0053] The difference between the two embodiments is the
disposition of the inflation lumen and the guide wire lumen. Whilst
the embodiment of FIG. 12 features a juxtaposed positioning of said
lumens, i.e. a side-by-side lumen shaft or dual lumen shaft, the
embodiment of FIG. 13 includes two concentric tubes comprising the
inflation lumen (107) and the guide wire lumen (110), i.e. a
coaxial shaft design. One of said tubes is the proximal tube
portion (111) that is disposed coaxially within an outer tube (126)
so that said two tubes (111) and (126) constitute a part of the
catheter shaft (105) of the embodiment of FIG. 13.
[0054] In another preferred embodiment of the present invention the
elastic segment (7) comprises an elastic tubular member (12)
treated with thermal transfer annealing.
[0055] Thermal transfer annealing is a method of thermally
treatment of thermally responsive material wherein areas in or on
the material to be thermally treated are defined and thermal energy
is inputted on or into the defined areas in order to
change/influence the material characteristics as described in U.S.
provisional application No. 60/736,515, which is incorporated
herewith herein in its entirety.
[0056] It is provided a method of thermal treatment of a thermally
responsive material being characterized by (a) defining areas in or
on the material to be thermally treated; and (b) inputting thermal
energy on or into the defined areas in order to change/influence
the material characteristics.
[0057] The invention is based on influencing the properties of
thermally responsive materials, in particular mechanical
characteristics and performance as pushability, kink resistance,
flexibility etc. by inputting energy on or into the material in
order to re-arrange the morphology and crystallinity in the
material structure.
[0058] According to the principles of the present invention, the
molecular structure of the material can be cross-linked in order to
enhance its properties and performance for varying fields of
application.
[0059] Materials suitable for the elastic member to undergo energy
treatment according to the present invention include but are not
limited to Polyurethanes (PU) (e.g. Tecoflex, Pellethene, Bionate,
corethane, Elasteon, and blends thereof); Polyethylenes (PE) (e.g.
PET, PBT, PVDF, Teflon, ETFE, and blends thereof; Polyolefins (e.g.
HDPE, PE; LDPE; LLDPE, Polypropylene, and blends thereof);
Polyimides; Polyamides; all classes of Nylons (e.g. Nylon 11; Nylon
12; Nylon 6,6; Nylon 6; Nylon 7,11; Nylon 11,12, and blends
thereof; Blockcopolymers, PEBA-types (e.g. ELY, PEBAX, Ubesta, and
blends thereof; and biodegradable polymers. Also suitable materials
are all kinds of blends of the above mentioned materials as well as
any composite materials, like duallayers, trilayers and
multilayers.
[0060] For energy treatment, the elastic member may be placed into
an energy source preferably on a mandrel that can for example be
coated with PTFE, Polyethylene or polypropylene. The energy source
and intensity to be utilized depends on the material to be treated.
The term thermal treatment within the scope of this invention
includes treatment with various energy sources. The energy sources
include but are not limited to wave energy, thermal energy, light
energy, laser energy, IR heat, UV light, ultrasound waves and
e-beam.
[0061] According to the present invention, it is possible to
describe any pattern on the outer surface or within the material of
the component to be treated, said pattern corresponding to areas
that have been defined before the thermal treatment in order to
intentionally influence certain regions in or on the material by
the thermal treatment. Examples for suitable patterns include but
are not limited to spirals with constant or varying pitch, rings,
lines, a multiplicity of offset lines, honeycombed patterns as well
as any lattice structures.
[0062] During the treatment the energy that is inputted in the
material or onto the material should be controlled such that the
energy does not lead to material ablation from the components to be
treated but only delivers sufficient energy to encourage especially
cross-linking in the material. The temperature range created by the
applied energy preferably includes all temperatures above the glass
transition temperature (T.sub.E) and all temperatures below the
melting temperature (T.sub.M) of the material to be treated
depending on the storage conditions as well as the water content of
the material.
[0063] The exact pattern, kind and amount of energy and especially
a rotational and/or longitudinal speed and pitch of the component
to be treated can be selected according to the desired material
characteristics to be achieved.
[0064] In a preferred embodiment the polymers to be treated
according to the present invention are doped with crosslinking
agents in order to adjust the degree of crosslinking upon energy
treatment. Crosslinking agents which can be employed include but
are not limited to .alpha., .omega.-olefins; 1,7-Octadiene;
1,9-Decadiene; Trivinylcyclohexane (TVCH); TAIC
(Trialylisocyanurate) and related compounds; Pyromellitic acid;
Benzophenone teracarboxylic dianhydride (BTDA); Pyromellitic
dianhydride (PMDA); Trimesic Acid; 5-Hexene-1-ol; Glycidol;
2-Allylphenol; Diallyl bisphenol-A; 1,3-Phenylene-bisoxazoline;
Guanamines; and DYHARD.
[0065] In another preferred embodiment the polymers to be treated
according to the present invention are doped with nucleating agents
or clarifying agents in order to make the polymer more prone to the
energy treatment and to be able to further adjust the degree of
crystallization of the polymer. Nucleating agents or clarifying
agents which can be used include but are not limited to sodium
benzoate; Sodium 2,2'-Methylene-bis(4,6-di-tert-butylphenyl)
phosphate; Sorbitol-derivatives: para-alkyl substituted
methyldibenzylidene Sorbitol; Dibenzylidene Sorbitol;
Dimethyldibenzlidene Sorbitol; .gamma.-Quinacridon; Pimelic
acid/Ca-Stearate; N',N'-Dicyclohexyl-2,6-Naphthaline dicarboxamide;
Potassium stearate, Sodium benzoate, micronisiated talcum;
Na.sub.2CO.sub.3; benzoic acid; CaF; Mg-, Ca-, Zn-salts of adipinic
acid; Zn-Phenylphosphinate; Zn-Phenylphosphonate;
Na-bis(4-tert-butylphenyl)phosphoric acid; Na/Cl-benzoate; Sodium
acids of Pyrrol-carboxylates;
Dimethyl-4,4'-terephthaloyldioxidibenzoate; 2-Hydroxybenzimidazole;
Bis (phenylbromide) methane; and Aluminium
hydroxyl-bis(4-tert-butylbenzoate).
[0066] Doping of the polymer can be uniform over the polymer
article or restricted to certain areas of the polymer article.
Further, the amount of the doping agent can vary over regions of
the polymer article. One or more doping agents can be used in
combination.
[0067] The temperature range of the treatment may include all
temperatures above the glass transition temperature (T.sub.E) and
all temperatures below the melting temperature (T.sub.M) for a
specific water content of the material to be treated, dependent on
storage conditions and water content of the material.
[0068] It is thus provided a method of treating an elastic member
according to the present invention with thermal transfer annealing.
It is further provided a catheter according to the present
invention comprising an elastic shaft segment manufactured by a
process including a step of thermal transfer annealing. Further, an
elastic shaft segment is provided, which is manufactured by a
process including a step of thermal transfer annealing.
[0069] FIG. 14A shows a distal portion of a catheter, comprising an
elastic segment (7) featuring a pattern that has been created by
inputting energy into the material and influencing thereby the
material characteristics. In the present case, the pattern is a
spiral with varying pitch, the pitch (30) being increased in distal
direction.
[0070] By site-specific reinforcement of the elastic tube by
thermal transfer annealing according to the present invention,
varying characteristics can be added to the elastic member. In
order to maintain pushability and trackability of the catheter,
varying patterns of reinforced material can be added to the elastic
member. Depending on balloon size and length, the ability of the
inner tube to stretch and contract can be easily adjusted.
Exemplary pattern include but are not limited to spiral
reinforcement with constant pitch or varying pitch, offset or
staggered straight reinforced lines along the length of the tube,
reinforced dots of varying density, chequered reinforcements, or
reinforced triangle patterns which taper to the distal portion, By
selective reinforcement of tube portions the degree of elasticity
and flexibility of the tube can be exactly adjusted to the special
needs of the particular catheter and its application.
[0071] It will be apparent to those skilled in the art that various
modifications and variations can be made in the device of the
present invention without departing from the spirit or scope of the
invention. Thus, it is intended that the present invention includes
modifications and variations that are in the scope of the appended
claims and their equivalents.
[0072] One skilled in the art would readily appreciate that the
present invention is well adapted to carry out the objects and
obtain the ends and advantages mentioned, as well as those inherent
therein. The devices described herein are presently representative
of preferred embodiments, are exemplary, and are not intended as
limitations on the scope of the invention. It will be readily
apparent to one skilled in the art that varying substitutions and
modifications may be made to the invention disclosed herein without
departing from the scope and spirit of the invention.
[0073] All patents and publications mentioned in the specification
are indicative of the levels of those skilled in the art to which
the invention pertains. All patents and publications are herein
incorporated by reference to the same extent as if each individual
publication was specifically and individually indicated to be
incorporated by reference. The invention illustratively described
herein suitably may be practiced in the absence of any element or
elements, limitation or limitations which is not specifically
disclosed herein. Thus, for example, in each instance herein any of
the terms "comprising," "consisting essentially of" and "consisting
of" may be replaced with either of the other two terms. The terms
and expressions which have been employed are used as terms of
description and not of limitation, and there is no intention that
in the use of such terms and expressions of excluding any
equivalents of the features shown and described or portions
thereof, but it is recognized that various modifications are
possible within the scope of the invention claimed. Thus, it should
be understood that although the present invention has been
specifically disclosed by preferred embodiments and optional
features, modification and variation of the concepts herein
disclosed may be resorted to by those skilled in the art, and that
such modifications and variations are considered to be within the
scope of this invention as defined by the appended claims.
* * * * *