U.S. patent application number 15/952576 was filed with the patent office on 2018-08-16 for balloon catheter with stent and method for manufacturing it.
The applicant listed for this patent is C.R. BARD, INC.. Invention is credited to Hendrik Jozef Maria Meens, Derk Trip.
Application Number | 20180228631 15/952576 |
Document ID | / |
Family ID | 26643338 |
Filed Date | 2018-08-16 |
United States Patent
Application |
20180228631 |
Kind Code |
A1 |
Meens; Hendrik Jozef Maria ;
et al. |
August 16, 2018 |
BALLOON CATHETER WITH STENT AND METHOD FOR MANUFACTURING IT
Abstract
The invention relates to a balloon catheter comprising a
catheter tube, an inflatable balloon, the ends of which are
attached to the catheter tube, and a stent attached around the
balloon. The stent extends at least partly along the length of the
balloon. In an uninflated state, at least the outside surface of
the balloon not covered by the stent is provided with a relief
structure which is substantially disappeared in an inflated state
of the balloon. The invention also relates to a method for
manufacturing such a balloon catheter.
Inventors: |
Meens; Hendrik Jozef Maria;
(Weert, NL) ; Trip; Derk; (Mierlo, NL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
C.R. BARD, INC. |
Murray Hill |
NJ |
US |
|
|
Family ID: |
26643338 |
Appl. No.: |
15/952576 |
Filed: |
April 13, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14310175 |
Jun 20, 2014 |
9993359 |
|
|
15952576 |
|
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|
13600342 |
Aug 31, 2012 |
8784470 |
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14310175 |
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|
11555466 |
Nov 1, 2006 |
8257418 |
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13600342 |
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10140479 |
May 7, 2002 |
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11555466 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 25/1027 20130101;
A61F 2/82 20130101; A61M 2025/1031 20130101; A61F 2002/9583
20130101; A61M 25/1002 20130101; A61M 2025/1086 20130101; A61M
25/1038 20130101; A61F 2/958 20130101; Y10T 29/49826 20150115 |
International
Class: |
A61F 2/958 20130101
A61F002/958; A61F 2/82 20130101 A61F002/82; A61M 25/10 20130101
A61M025/10 |
Foreign Application Data
Date |
Code |
Application Number |
May 8, 2001 |
NL |
1018018 |
Sep 4, 2001 |
NL |
1018881 |
Claims
1. A balloon catheter comprising: a catheter body; a balloon
connected to the catheter body having: a stent balloon section; a
groove balloon section; and a masked balloon section; and a stent,
wherein the balloon is configured to have a delivery configuration
in which the balloon is in a folded state and a stent-deployment
configuration in which the balloon is in an inflated state, and in
the delivery configuration, the balloon displays wire indentations
on the groove balloon section.
2. The catheter of claim 1 wherein in the stent-deployment
configuration, the wire indentations disappear.
3. The catheter of claim 2 wherein the masked balloon section is
free of wire indentations.
4. The catheter of claim 3 wherein a relief structure reduces a
balloon profile.
5. The catheter of claim 3 wherein wire indentations create a
relief structure.
6. The catheter of claim 5 wherein a relief structure reduces a
balloon profile.
7. The catheter of claim 6 further comprising a pressure sleeve
disposed over the stent.
8. The catheter of claim 7 further comprising a masking material
disposed over stent ends.
9. The catheter of claim 7 wherein the relief structure opposes
stent movement.
10. The catheter of claim 1 wherein the masked balloon section is
free of wire indentations.
11. The catheter of claim 10 wherein wire indentations create a
relief structure.
12. The catheter of claim 11 wherein wire indentations create a
relief structure.
13. The catheter of claim 12 wherein the relief structure opposes
stent movement.
14. The catheter of claim 1 wherein wire indentations create a
relief structure.
15. The catheter of claim 14 wherein a relief structure reduces a
balloon profile.
16. The catheter of claim 15 wherein the relief structure opposes
stent movement.
17. The catheter of claim 1 wherein the masked balloon section is
free of wire indentations and wire indentations create a relief
structure.
18. The catheter of claim 3 wherein a relief structure reduces a
balloon profile.
19. A balloon catheter comprising: a catheter body; a balloon
connected to the catheter body having: a stent balloon section; a
groove balloon section comprising a wire indentation wherein the
wire indentation creates a relief structure and the relief
structure reduces a balloon profile; and a masked balloon section
free of wire indentations wherein the relief structure opposes
stent movement; and a stent disposed over the stent balloon
section, wherein the balloon is configured to have a delivery
configuration in which the balloon is in a folded state, the
balloon is configured to have a stent-deployment configuration in
which the balloon is in an inflated state, in the delivery
configuration, the balloon displays wire indentations on the groove
balloon section, and in the stent-deployment configuration, the
wire indentations disappear.
Description
[0001] This application is a continuation of Ser. No. 11/555,466,
which is a divisional of Ser. No. 10/140,479, the disclosures of
which are incorporated herein by reference.
TECHNICAL FIELD
[0002] The present invention relates to a balloon catheter
comprising a catheter tube, an inflatable balloon which at its ends
is attached to the catheter tube and a stent attached around the
balloon, wherein the stent extends at least in part along the
length of the balloon. The invention further relates to a method of
manufacturing a balloon catheter.
BACKGROUND INFORMATION
[0003] Balloon catheters of this type are generally known and are
used for dilating vessels and lumina and for placing the stent in
the dilated vessel or lumen. In order to pass the balloon catheter
easily and safely through the vessels and lumina and to position it
at the required place for dilatation, it is important that the
balloon catheter has a small profile (outer diameter) and is
sufficiently flexible.
[0004] The object of the invention is therefore to provide an
improved balloon catheter.
BRIEF SUMMARY OF THE INVENTION
[0005] The balloon catheter according to the invention is
characterized in that, in an uninflated state, at least the outside
surface of the balloon that is not covered by the stent is provided
with a relief structure which in an inflated state of the balloon
is substantially disappeared.
[0006] Tests have shown that with a relief structure on the outside
surface of the balloon a catheter is obtained that is more flexible
than a standard balloon catheter. The balloon catheter according to
the invention can therefore be passed more easily and more safely
through vessels and lumina to the point of dilatation. Because of
its flexibility, the catheter will be able to adapt better to a
bend in a vessel or a lumen, thus reducing the risk of damage to
the vessel or lumen.
[0007] The required relief structure may have different
embodiments, but preferably comprises at least one groove that
extends at least transversely in the longitudinal direction of the
balloon in order to give the catheter the required flexibility in a
direction transverse to the longitudinal direction thereof.
[0008] The groove preferably extends at a predetermined angle with
respect to the longitudinal direction of the balloon. According to
a preferred embodiment, the groove extends helically from one end
to the other end of the balloon, over the outside surface
thereof.
[0009] According to another embodiment, the relief structure
comprises two or more grooves that extend helically from one end to
the other end of the balloon, crossing each other. Tests have shown
that with such a relief structure a very flexible balloon catheter
is obtained which also has a relatively low profile.
[0010] The invention also relates to a method for producing a
balloon catheter comprising Attaching the ends of an inflatable
balloon to a catheter tube and placing a stent around the balloon,
whereby according to the invention at least the outside surface of
the balloon not covered by the stent is provided with a relief
structure.
[0011] According to a first embodiment, the outside surface of the
balloon is first provided with the relief structure and then the
stent is attached around the balloon. An additional advantage of
this embodiment is that a better fixing of the stent to the balloon
is achieved. The improvement in fixing is due to the relief that
makes the usual smooth surface of the balloon "rough". The stent
adheres better to this rough surface.
[0012] According to a second embodiment, the stent is first
attached around the balloon and then the outside surface is
provided with the relief structure. A more flexible stent fixing
system is obtained because at least the balloon material near the
stent, both distally and proximally, is provided with a profile.
Also, the stent placing system has obtained a smaller profile
compared with known stent placing systems.
[0013] The relief structure is preferably produced on the
application of heat to the surface of the balloon in order to
deform the elastic material of the balloon.
[0014] The relief structure is also preferably produced on the
surface of the balloon by applying a high pressure to the inside of
the balloon.
[0015] According to a very inexpensive method, the relief structure
is produced on the surface of the balloon by winding a wire around
the balloon in the form of a helix.
[0016] According to another simple method, the relief structure is
produced on the surface of the balloon by taking up the balloon in
a counter-pressure body that has the relief structure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The invention is explained in more detail on the basis of
the drawings attached. The drawings show:
[0018] FIG. 1A is a side view of a form of a balloon catheter in an
uninflated state,
[0019] FIG. 1B is a side view of the catheter in FIG. 1A in an
inflated state,
[0020] FIG. 2A is a side view of a second embodiment of a balloon
catheter during the execution of the method according to the
invention, and
[0021] FIG. 2B is a side view of the final product of FIG. 2A.
DETAILED DESCRIPTION OF THE INVENTION
[0022] A balloon catheter according to the invention comprises a
catheter tube 1, an inflatable balloon 2, which at its ends 3 is
attached to the catheter tube 1, and a stent 6 attached around the
balloon 2. The stent 6 extends partly along the length of the
balloon 2 such that with the catheter, both distally and proximally
next to the stent 6, balloon material lies freely. In an uninflated
state (FIG. 1A), the outside surface of the balloon 2 has a relief
structure 4 that in the inflated state has virtually or completely
disappeared (FIG. 1B). The relief structure 4 gives the distal end
of the catheter its required flexibility.
[0023] In the embodiments shown, the relief structure 4 consists of
two grooves 5, which extend helically from one end 3 to the other
end 3 of the balloon 2 and cross each other. The uninflated balloon
2 has thereby obtained a padded relief surface. It is also possible
to provide a relief structure with a single helically shaped groove
5 whereby the uninflated balloon 2 displays a relief surface in the
form of a helix. Other relief structures are of course possible,
provided that the relief, structure on the catheter creates the
necessary flexibility in a direction transverse to the longitudinal
direction of the balloon.
[0024] One way of obtaining the relief structure as shown in the
drawings is by winding a wire helically around the balloon 2. This
wire may, for example, be nylon wire or wire made of a different
material that contracts somewhat on heating. After the wire has
been wound around the balloon, a sleeve is pulled over the balloon.
Subsequently, with the application of raised pressure to the inside
of the balloon, the balloon is heated in such a way that in an
uninflated state the balloon obtains a relief structure that on
dilating of the balloon at the dilatation site in the vessel or
lumen will virtually or completely disappear. The sleeve is then
removed and the balloon catheter can be inserted into a vessel or
lumen.
[0025] The method according to the invention can be carried out in
two ways. In the first way, the profile is first applied to the
balloon by winding this around with wire and heating it under
internal pressure, and then the stent is placed on the balloon.
This results in improved flexibility and maneuverability of the
distal part of the catheter. Better fixing of the stent on the
"rough", profiled surface of the balloon is also achieved. In the
second way, a stent is first placed on the balloon and then the
complete distal part of the catheter, namely the balloon including
the stent that has been placed in position, is wound around with
wire, preferably nylon wire. Then the whole assembly is heated at a
certain internal pressure. Winding produces a helical profile in
the balloon material next to the stent. At the same time the
diameter of the catheter with the stent is reduced because the
nylon wire shrinks on heating. In a variation of this last method,
first filler material 8 is placed next to the stent, over which
wire is then also wound (see FIG. 2A). In the end this results in a
small increase 7 in the balloon material next to the stent 6 (see
FIG. 2B), into which the ends of the stent 6 can be pressed. As a
result the ends of the stent 6 are better protected if the stent
placing system is passed in a curved trajectory.
[0026] Instead of winding the wire, the balloon may be placed in a
mould, which is provided with the relief pattern required, in order
for it to obtain, under raised pressure and temperature, the relief
structure required.
[0027] Before the balloon is provided with its relief structure,
preferably it is folded in the usual way in order to reduce its
profile. By applying the relief structure, the profile will be
reduced as an additional, advantageous effect.
[0028] Note that, although it is not shown in the drawings, it is
possible to provide the outside surface of the balloon with various
helical grooves that cross each other. In addition to helical
grooves, grooves of other shapes are also possible.
[0029] The balloon catheter may be used not only in cardiological
but also radiological interventions.
* * * * *