U.S. patent application number 12/695109 was filed with the patent office on 2010-05-27 for self-expanding medical occlusion device.
Invention is credited to Hans Reiner Figulla, Susann Klebon, Friedrich Moszner, Robert Moszner, Rudiger Ottma.
Application Number | 20100131007 12/695109 |
Document ID | / |
Family ID | 38264240 |
Filed Date | 2010-05-27 |
United States Patent
Application |
20100131007 |
Kind Code |
A1 |
Figulla; Hans Reiner ; et
al. |
May 27, 2010 |
Self-Expanding Medical Occlusion Device
Abstract
A self-expanding medical occlusion device treats a heart defect
in a patient and is erted into the body in minimally invasive
fashion using a catheter system, and includes raiding of thin
threads which exhibits a first preliminarily definable shape as the
clusion device is being inserted into the patient's body and a
second preliminarily finable shape in the implanted state, whereby
the occlusion device is in a collapsed te in the first shape of the
braiding and in an expanded state in the second shape of braiding.
The threads of braiding are composed of a shape memory polymer
mposite such that braiding deforms from a temporary shape to a
permanent shape in nsequence of an external stimulus, whereby the
temporary shape is given in a first ofile form of the braiding and
the permanent shape is given in a second profile form of
braiding.
Inventors: |
Figulla; Hans Reiner; (Jena,
DE) ; Klebon; Susann; (Jena, DE) ; Moszner;
Friedrich; (Hohlstedt, DE) ; Moszner; Robert;
(Bad Klosterausnitz, DE) ; Ottma; Rudiger;
(Grossschwabhausen, DE) |
Correspondence
Address: |
INSKEEP INTELLECTUAL PROPERTY GROUP, INC
2281 W. 190TH STREET, SUITE 200
TORRANCE
CA
90504
US
|
Family ID: |
38264240 |
Appl. No.: |
12/695109 |
Filed: |
January 27, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11271750 |
Nov 14, 2005 |
7665466 |
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12695109 |
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Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 2017/00606
20130101; A61B 2017/00592 20130101; A61B 2017/12054 20130101; A61B
17/12022 20130101; A61B 2017/00575 20130101; A61B 17/12177
20130101; A61B 17/12122 20130101; A61B 2017/12095 20130101; A61B
17/12172 20130101; A61B 2017/00871 20130101; A61B 2017/00938
20130101; A61B 17/0057 20130101; A61B 17/12109 20130101; A61B
2017/00867 20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 17/03 20060101
A61B017/03 |
Claims
1. A method for implanting a medical occlusion device comprising a
degradable material for treating defects in a patient, in
particular closing abnormal openings in tissue, comprising:
positioning a catheter in the body of the patient such that a
distal end of the catheter is positioned at the site to be treated,
collapsing the occlusion device in a first preliminarily definable
shape, inserting the occlusion device into the catheter, pushing
the occlusion device through the catheter such that the occlusion
device exits at said distal end, expanding the occlusion device
from the first shape to a second preliminarily definable shape in
the implanted state of the occlusion device, and wherein the
occlusion device in the first shape is in a collapsed state and the
occlusion device in the second shape is in an expanded state, and
whereby the occlusion device will degrade after a given interval of
time.
2. The method for implanting a medical occlusion device according
to claim 1, wherein said degradable material is a polymer
composite.
3. The method for implanting a medical occlusion device according
to claim 2, wherein said polymer composite is a shape memory
polymer composite.
4. The method for implanting a medical occlusion device according
to claim 3, wherein the occlusion device comprise a braiding of
thin threads of the shape memory polymer composite, whereby the
braiding will deform from a temporary shape to a permanent shape by
means of an external stimulus; and wherein the temporary shape is
given in the first shape of braiding and the permanent shape is
given in the second shape of braiding.
5. The method for implanting a medical occlusion device according
to claim 1, wherein the degrading of the occlusion device is
controlled at a variable speed.
6. The method for implanting a medical occlusion device according
to claim 1, wherein the degrading of the occlusion device comprises
removal of the degradable material from the body due to natural
metabolism.
7. The method for implanting a medical occlusion device according
to claim 2, wherein the polymer composite exhibits a hydrolytically
degradable polymer, in particular poly(hydroxy carboxylic acids) or
the corresponding copolymers.
8. The method for implanting a medical occlusion device according
to claim 2, wherein the polymer composite exhibits enzymatically
degradable polymers.
9. The method for implanting a medical occlusion device according
to claim 2, wherein the polymer composite exhibits a biodegradable
thermoplastic amorphous polyurethane-copolyester polymer
network.
10. The method for implanting a medical occlusion device according
to claim 2, wherein the polymer composite exhibits biodegradable
elastic polymer network, obtained from crosslinking of oligomer
diols with diisocyanate.
11. The occlusion device in accordance with claim 2, wherein the
polymer composite is formed as covalent networks based on
oligo(.epsilon.-caprolactone)dimethacrylate and butylacrylate.
12. The method for implanting a medical occlusion device according
to claim 4, wherein said external stimulus is a definable switching
temperature.
13. The method for implanting a medical occlusion device according
to claim 12, wherein the switching temperature is within a range of
between room temperature and the patient's body temperature.
14. The method for implanting a medical occlusion device according
to claim 12, wherein the polymer composite comprises polymer
switching elements; and wherein the temporary shape of said
braiding is stabilized below the definable switching temperature
based on the characteristic phase transitions of polymer switching
elements.
15. The method for implanting a medical occlusion device according
to claim 14, wherein the polymer composite exhibits a crystalline
or semi-crystalline polymer network having crystalline switching
segments; wherein the temporary shape to said braiding is fixed and
stabilized by freezing the crystalline switching segments at
crystallization transition; and wherein the switching temperature
is a function of the crystallization temperature, of the switching
temperature of the crystalline switching segments respectively.
16. The method for implanting a medical occlusion device according
to claim 14, wherein the polymer composite exhibits an amorphous
polymer network having amorphous switching segments; and wherein
the temporary shape to said braiding is fixed and stabilized by
freezing of the amorphous switching segments at the switching
segment glass transition; whereby the switching temperature is a
function of the glass transition temperature of the amorphous
switching segments.
17. The method for implanting a medical occlusion device according
to claim 12, wherein the polymer composite comprises a linear,
phase-segregated multi-block copolymer network which can exhibit at
least two different phases; and wherein the first phase is a hard
segment-forming phase in which a plurality of hard segment-forming
blocks are formed in the polymer which serve the physical
crosslinking of the polymer structure and define and stabilize the
permanent shape to said braiding; and wherein the second phase is a
switching segment-forming phase in which a plurality of switching
segment forming blocks are formed in the polymer which serve to fix
the temporary shape of said braiding; and wherein the transition
temperature from the switching segment-forming phase to the hard
segment-forming phase is the switching temperature; and wherein
conventional methods such as injection molding or extrusion
processes can be used to set the profile form to said braiding
above the transition temperature of the hard segment-forming
phase.
18. The method for implanting a medical occlusion device according
to claim 17, wherein the polymer composite exhibits thermoplastic
polyurethane elastomers of a multi-block structure; and wherein the
hard segment forming phase is formed by conversion of
diisocyanates, in particular methylene-bis(4-phenylisocyanate) or
hexamethylene diisocyanate, with diols, in particular
1,4-Butandiol; and wherein the switching segment-forming phase
yields from oligomeric polyether/poly-esterdiols, in particular
based on OH-terminated oly(tetrahydrofuran),
poly(.epsilon.-caprolactone), poly(ethylene adipate), poly(ethylene
glyocol) or poly(propylenglycol).
19. The method for implanting a medical occlusion device according
to claim 17, wherein the phase-segregated di-block copolymers of
the polymer composite exhibit an amorphous A-block and a
semi-crystallized B-block; and wherein the glass transition of the
amorphous A-block constitutes the hard segment forming phase; and
wherein the melting temperature of the semi-crystalline B-block
serves as the switching temperature for the thermal shape memory
effect.
20. The method for implanting a medical occlusion device according
to claim 19, wherein the polymer composite has polystyrol as the
amorphous A-block and poly(1,4-butadiene) as the semi-crystalline
B-block.
21. The method for implanting a medical occlusion device according
to claim 17, wherein the polymer composite exhibits a
phase-segregated tri-block copolymer having a semi-crystalline
central B-block and two amorphous terminal A-blocks; wherein the
A-blocks constitute the hard segment and the B-block establishes
the switching temperature.
22. The method for implanting a medical occlusion device according
to claim 21, wherein the polymer composite exhibits
semi-crystalline poly-(tetrahydrofuran) as the central B-block and
amorphous poly(2-methyloxazolin) as terminal A-blocks.
23. The method for implanting a medical occlusion device according
to claim 3, wherein the polymer composite comprises polynorbornene,
polyethylene/nylon-6-graft copolymers and/or crosslinked
poly(ethylene-covinyl acetate) copolymers.
24. The method for implanting a medical occlusion device according
to claim 3, wherein the polymer composite exhibits a covalent
crosslinked polymer network which is formed by polymerization,
polycondensation and/or polyaddition of difunctional monomers or
macromers with additive of tri or higher functional crosslinking;
and wherein given an appropriate selection of the monomers, their
functionality and ratio of crosslinkers, the chemical, thermal and
mechanical properties of the polymer network as formed can be
specifically and selectively set.
25. The method for implanting a medical occlusion device according
to claim 24, wherein the polymer composite is a covalent polymer
network which comprises a crosslinker by crosslinking
copolymerization of stearylacrylate and methacrylic acid with
N,N'-methylenebisacrylamide, whereby the shape memory effect of the
polymer composite is based on crystallizing stearyl-side
chains.
26. The method for implanting a medical occlusion device according
to claim 2, wherein the polymer composite exhibits a covalent
crosslinked polymer network which is formed by subsequent
crosslinking of linear or branched polymers.
27. The method for implanting a medical occlusion device according
to claim 3, wherein a shape memory polymer network is synthesized
from a combination of physical or covalent shape memory polymer
networks having biodegradable polymer segments.
28. The method for implanting a medical occlusion device according
to claim 27, wherein said shape memory polymer network is used as a
matrix for a controlled release of an active substance.
29. The method for implanting a medical occlusion device according
to claims 9 and 14, wherein the amorphous polyurethane-copolyester
polymer network having segments in biodegradable
poly(p-diaxanone)-polyurethane (P DO) multi-block copolymers in
combination with poly(lacti-co-glycolid) (PDLG) and
poly(epsilon-caprolactone) PCL switching segments.
30. The method for implanting a medical occlusion device according
to claim 9, wherein the amorphous polyurethane-copolyester polymer
network is formed by synthesizing biodegradable star-shaped
copolyester polyols based on dilactile DL (cyclic lactic acid
dimer), diglyocolide DG (cyclic glycol acid dimer) and
trimethylolpropane TP (F=3) or pentaerythrit PE (F=4) and
crosslinking with trimethylhexa methylene diisocyanate TMDI.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to a self-expanding medical
occlusion device for treating heart defects in patients, in
particular closing abnormal openings in tissue, whereby the
occlusion device is introduced into the body of a patient in
minimally invasive fashion using a catheter system and consists of
a braiding of thin threads, whereby the braiding exhibits a first
preliminarily definable shape as the occlusion device is being
inserted into the patient's body and a second preliminarily
definable shape in the implanted state of the occlusion device,
whereby the braiding of said occlusion device in the first profile
form is in a collapsed state and the braiding in the second profile
form is in expanded state.
[0003] 2. Description of the Related Art
[0004] The principle behind this type of occlusion device is known
to at least some extent in medical technology. For example, an
occlusion device for treating septum defects is known from DE 10
338 702 of Aug. 22, 2003, consisting of a braiding of thin wires or
threads and given a suitable profile in a molding and heat
treatment process. The known occlusion device has a proximal
retention area which is particularly distinctly flat, a distal
retention area, and a cylindrical crosspiece between said proximal
and distal retention areas. The ends of the wires forming the
braiding converge into a holder in the distal retention area. This
is hence designed as such so that the two retention areas of the
known occlusion device will position on the two sides of a shunt to
be occluded in a septum, usually by means of an intravascular
surgical procedure, while the crosspiece will transverse the
shunt.
[0005] Medical technology has long endeavored to be able to occlude
septal defects, for instance atrioseptal defects, by means of
non-surgical transvenous catheter procedures, in other words,
without having to perform an operation in the literal sense.
Various different occlusion systems have been proposed, each with
their own pros and cons, without any one specific occlusion system
having yet become widely accepted.
[0006] In making reference to these different systems, the
following will use the terms "occluder" or "occlusion device." In
all interventional occlusion systems, a self-expanding umbrella
system is introduced transvenously into a defect to be occluded in
a septum. This type of system might comprise two umbrellas: one,
for example, positioned at the distal side of the septum (i.e. the
side furthest from the median plane of the body/heart) and one at
the proximal side of the septum (i.e. the side closer to the median
plane of the body), whereby the two umbrella prostheses are
subsequently secured to a double umbrella in the septal defect.
Thus, in the assembled state, the occlusion system usually consists
of two clamped umbrellas connected to one another by means of a
short bolt transversing the defect.
[0007] However, a disadvantage to such prior art occlusion devices
turns out to be the relatively complicated, difficult and complex
implantation procedure. Apart from the complicated implantation of
the occlusion system in the septal defect to be occluded, the
umbrellas utilized are susceptible to material fatigue along with
fragment fracture. Furthermore, thromboembolic complications are
frequently to be anticipated.
[0008] In order to enable the inventive occlusion device to be
introduced by means of a surgical insertion instrument and/or
guidewire, a holder is provided at the end of the distal retention
area which can engage with the insertion instrument and/or
guidewire. It is thereby intended that this engagement can be
readily disengaged after positioning the occlusion device in the
defect. For example, it is possible to devise the braiding at the
end of the distal retention area of the occlusion device in such a
manner so as to create an internal threading in the holder to
engage with the insertion instrument. Of course, other embodiments
are naturally also conceivable.
[0009] With another type of occlusion device, the so-called
Lock-Clamshell umbrella system, two stainless steel preferably
Dacron-covered umbrellas are provided, each stabilized by four
arms. This type of occluder is implanted into the patient through a
vein. However, seen as problematic with the Lock-Clamshell occluder
is the fact that the insertion instruments necessary to implant the
device need to be of relatively large size. A further disadvantage
seen with other systems, for example the Amplatz occluder, is that
many different occluder sizes are needed in order to cope with the
respective dimensions of the septal defects to be occluded. It thus
turns out that the umbrellas do not flatten out completely in the
inserted state if the length or the diameter of the crosspiece
inserted into the defect is not of an optimum match. This results
in incomplete endothelialization. It has furthermore been shown
that many of the systems implanted into patients' bodies exhibit
material fatigue and fractures in the metallic structures due to
the substantial mechanical stresses over a longer period. This is
especially the case given permanent stress between an implant and
the septum.
[0010] In order to overcome these disadvantages, self-centering
occlusion devices have been developed which are inserted into the
body of the patient and introduced into the septal defect to be
occluded by way of a minimally invasive procedure, for example
using a catheter and guidewires. Their design is based on the
principle that the occlusion device can be tapered to the
dimensions of the insertion instrument and/or catheter used for the
intravascular procedure. Such a tapered occlusion device is then
introduced by catheter into the septal defect to be occluded,
respectively into the shunt of the septum defect to be occluded.
The occluder is then discharged from the catheter, upon which the
self-expanding umbrellas, retention plates respectively,
subsequently unfold against the two sides of the septum. The
umbrellas in turn comprise fabric inserts made from or covered by,
for example, Dacron, with which the defect/shunt is occluded. The
implants remaining in the body are more or less completely ingrown
by the body's own tissue after a few weeks or months.
[0011] An example of a self-centering occlusion device of the type
specified is known from WO 99/12478 A1, which is a further
development of the occlusion device known as the "Amplatz occluder"
in accordance with U.S. Pat. No. 5,725,552. Same consists of a
braiding of a plurality of fine, intertwined nitinol wire strands
in the shape of a yo-yo. Each braiding is produced in its original
form as a rounded braiding having loose wire ends both at its
leading end (its proximal side, respectively) as well as at its
trailing end (its distal side, respectively). During the subsequent
processing of the rounded braiding, each of these loose ends must
then be gathered into a sleeve and welded together. After the
appropriate processing, both the proximal side as well as the
distal side of the finished occluder exhibit a protruding collar.
Dacron patches are sewn into the distal and proximal retention
umbrellas and the interposed crosspiece. Because of the memory
effect exhibited by the nitinol material used, the two retention
umbrellas unfold by themselves upon exiting the catheter, initially
in a balloon-like intermediate stage, whereby the retention
umbrellas ultimately positioned on the two sides of the septum
eventually assume a more or less flattened form. The crosspiece
centers itself automatically into the shunt to be occluded during
the positioning of the umbrellas.
[0012] The shape memory nitinol material known from prior art
occlusion devices and that as previously described has, however,
proven to have certain disadvantages with respect to occlusion
devices. Nitinol, which is an atomistic alloy of nickel and
titanium, is only conditionally suitable as a shape memory material
for medical occlusion devices because the maximum deformation for
nitinol between the first preliminarily definable shape given as
the occlusion device is being inserted into the body of the patient
and the second preliminarily definable shape given when the
occlusion device is in implanted state only amounts to about 8%. In
other words, this means that the shape memory nitinol material is
only conditionally suitable for collapsing an occlusion device as
small as possible for the implantation procedure. Hence, the
implantation procedure when using a medical occlusion device which
has braiding made from nitinol is not a particularly gentle one on
the patient. Moreover, being an alloy of nickel and titanium,
nitinol constitutes a permanent foreign body such that once in the
implanted state, relevant defense system reactions can be expected
from the body.
[0013] On the basis of the problematic task as set forth, which is
in particular coupled with the use of nitinol as a shape memory
material for medical occlusion devices, the task on which the
present invention is based is that of improving upon a
self-expanding medical occlusion device of the type specified at
the outset to afford the patient a gentler implantation of the
device.
SUMMARY OF THE INVENTION
[0014] This task is solved in accordance with a self-expanding
medical occlusion device of the type specified at the outset which
inventively has the threads of the braiding including a shape
memory polymer composite so that the braiding is deformed from a
temporary shape to a permanent shape by means of an external
stimulus, whereby the temporary shape is given in a first profile
form and the permanent shape is given in a second profile form.
[0015] The inventive solution has a number of significant
advantages over the known and above-described medical occlusion
devices of the prior art. Especially because a shape memory polymer
composite exhibits considerably better memory properties than
nitinol, a far gentler implantation is afforded when implanting
said medical occlusion device. Compared to known shape memory
materials, for example the nitinol shape memory alloy; i.e., an
atomistic alloy of nickel and titanium, shape memory polymers are
far superior in terms of their memory properties. Only little
effort is required in the (heating/cooling) process to program the
temporary shape or, respectively, to restore the permanent shape.
Moreover, in the case of nitinol, for example, the maximum
deformation between permanent and temporary shape amounts to just
8%. In contrast, shape memory polymers exhibit substantially higher
deformability capabilities of up to 1100%.
[0016] The inventive polymer composite also exhibits advantages
over the prior art with respect to the manufacturing process since
conventional processing methods can be used. For example, the
polymer could conceivably be initially given its permanent shape
using conventional processing methods such as injection molding or
extrusion. The synthetic can then be subsequently deformed and
fixed in its desired temporary shape, which is a process known as
"programming." This procedure can ensue with polymers such that the
specimen is heated, deformed and then cooled. Or the
polymer/synthetic can also be deformed at lower temperature, a
process known as "cold drawing." The permanent form thus becomes a
memory shape which is remembered while still in temporary form.
Once an external stimulus acts on the molded polymer body, this
leads to the shape memory effect being triggered and thus to a
restoring of the permanent memory shape. Cooling the specimen
effects an irreversible degeneration of the temporary shape, which
is why this is referred to as a so-called one-way shape memory
effect. The original temporary form--as well as other forms--can be
reprogrammed upon new mechanical deformation being effected.
[0017] Shape-memory polymers are included in a group which is known
as smart polymers in English and are polymers which exhibit a shape
memory effect; i.e., which are able to change their outer form in
response to external stimuli such as, for example, a change in
temperature. The above-described process of programming and shape
restoration is depicted schematically in FIG. 1.
[0018] A particularly preferred implementation provides for the
external stimulus being a definable switching temperature. It is
thus conceivable that in order to trigger the shape memory effect
and thus the restoring of the permanent memory shape, the braiding
of the molded polymer body must be heated to a higher temperature
than the switching temperature. Appropriately selecting the
chemical composition to a polymer composite allows the initial
specifying of such a specific transition temperature.
[0019] It is thus particularly preferred to set the switching
temperature within a range of between room temperature and the
patient's body temperature. This is of particular advantage as
regards the application of the occlusion device as an implant in
the body of a patient. As such, all that must be ensured when
implanting the occlusion device is that the device is not warmed up
to the patient's body temperature (36.degree. C.), which would
trigger the polymer's shape memory effect, until in the implanted
state.
[0020] One possible implementation of the inventive occlusion
device in which the external stimulus is a definable switching
temperature provides for the polymer composite to comprise polymer
switching elements, whereby the temporary shape of the braiding is
stabilized below the definable switching temperature based on the
characteristic phase transitions of the polymer switching
elements.
[0021] It is thus conceivable, for example, that should the polymer
composite exhibit a crystalline or semi-crystalline polymer network
having crystalline switching segments,
[0022] the temporary shape to the braiding is fixed and stabilized
by freezing the crystalline switching segments at crystallization
transition, whereby the switching temperature is a function of the
crystallization temperature, the switching temperature of the
crystalline switching segments respectively.
[0023] On the other hand, in the case of a polymer composite such
as an amorphous polymer network having amorphous switching
segments, it is feasible to fix and stabilize the temporary shape
of the braiding at glass transition by freezing of the amorphous
switching segments, whereby the switching temperature is a function
of the glass transition temperature of the amorphous switching
segments.
[0024] In accordance with these preferred embodiments,
characteristic phase transitions can thus be used to stabilize the
temporary shape of the shape memory polymers; i.e., crystallization
in the case of crystalline or semi-crystalline polymers and glass
transition in the case of amorphous polymers. Accordingly, in the
case of elastic polymers composed of covalent bonded polymer
networks, the mechanism of shape memory transition is based on the
one hand on the stabilizing of the permanent shape by chemical
bonding of the polymer chains and, on the other, by the fixing of
the temporary form by crystallization of segments (semi-crystalline
polymer networks) or by freezing the switching segments in the case
of glass transition (amorphous polymer networks). The T.sub.trans
switching temperature, the exceeding of which triggers the shape
memory effect, is accordingly contingent upon the synthetic's
T.sub.m, melting temperature, the T.sub.g glass transition
temperature respectively, in the corresponding temperature
range.
[0025] FIG. 2 schematically depicts the molecular mechanism of a
thermally-induced shape-memory transition for a semi-crystalline
polymer network. When the ambient temperature is higher than
T.sub.trans (T.sub.m) of the crystalline switching segments, these
segments are then flexible and can be elastically deformed, for
example stretched.
[0026] The temporary shape which is formed is fixed by cooling
below T.sub.trans (T.sub.m); i.e., by the crystalline areas forming
upon cooling, acting quasi as physical crosslinks. When the polymer
is heated above T.sub.trans (T.sub.m), the permanent shape is once
again restored. The thermodynamic force driving the resumption of
the permanent shape is the entropic gain thereby realized.
Amorphous polymer networks having shape memory effect function
similar to the semi-crystalline polymer networks having shape
memory effect, whereby the switching temperature represents the
glass transition temperature and the temporary shape is fixed by
freezing the mobility of the amorphous switching segments.
[0027] Another advantageous implementation or development of the
previously-cited embodiments of the inventive occlusion device
provides for the polymer composite to comprise a linear,
phase-segregated multiblock copolymer network which can exhibit at
least two different phases, whereby the first phase is a hard
segment-forming phase in which a plurality of hard segment-forming
blocks are formed in the polymer which serve the physical
crosslinking of the polymer structure and define and stabilize the
permanent shape to the braiding, and whereby the second phase is a
switching segment-forming phase, in which a plurality of switching
segment-forming blocks are formed in the polymer which serve to fix
the temporary shape of the braiding, whereby the transition
temperature from the switching segment-forming phase to the hard
segment-forming phase is the switching temperature, and whereby
conventional methods such as injection molding or extrusion
processes can be used to set the profile form to the braiding above
the transition temperature of the hard segment-forming phase.
[0028] With respect to the chemical composition of the polymer
composite of which the braiding of the inventive medical occlusion
device is comprised, a preferred implementation of the inventive
medical occlusion device having a braiding consisting of a shape
memory polymer composite can provide for the polymer composite to
have thermoplastic polyurethane elastomers of a multiblock
structure, whereby the hard segment-forming phase is formed by
conversion of diisocyanates, in particular
methylene-bis(4-phenylisocyanate) or hexamethylene diisocyanate,
with diols, in particular 1,4-butanediol, and whereby the switching
segment-forming phase yields from oligomeric
polyether/poly-esterdiols, in particular based on OH-terminated
poly(tetrahydrofuran), poly(.epsilon.-caprolactone), poly(ethylene
adipate), poly(ethylene glyocol) or poly(propylenglycol).
[0029] In an alternative yet advantageous implementation, it is
conceivable for the phase-segregated diblock copolymers of the
polymer composite to exhibit an amorphous A-block and a
semi-crystallized B-block, whereby the glass transition of the
amorphous A-block constitutes the hard segment-forming phase, and
whereby the melting temperature of the semi-crystalline B-block
serves as the switching temperature for the thermal shape memory
effect.
[0030] It is advantageously provided in the latter preferred
implementation with respect to the polymer composite for this
compound to have polystyrol as the amorphous A-block and
poly(1,4-butadiene) as the semi-crystalline B-block.
[0031] In consequence thereof, the linear phase-segregated
multiblock copolymers constitute an important group of shape memory
polymers. These polymers have two separate phases, whereby the one
phase with the higher transition temperature serves the physical
crosslinking and for defining the permanent shape. Conventional
processes for profile shaping such as injection molding or
extrusion can be used above this melting temperature. As indicated
above, the second phase is then molecular switching and serves to
fix the temporary shape, whereby the transition temperature of the
switching phase (T.sub.trans) can be a melting or a glass
transition temperature.
[0032] Included among the shape memory polymers which function in
accordance with this operating principle based on linear block
copolymers are thermoplastic polyurethane elastomers having a
multiblock structure.
[0033] As shown in FIGS. 3 and 4, the hard segment-forming phase is
usually a process of converting commercial diisocyanates such as,
for example, methylene-bis(4-phenyliso-cyanate) (MDI) or
hexamethylene diisocyanate (HMDI) with commercial diols such as,
for example, 1,4-butanediol. The switching segment-forming phase
then yields from the commercially-available oligomeric
polyether/polyesterdiols used such as, for example, based on
OH-terminated poly(tetrahydrofuran), poly(.epsilon.-caprolactone),
poly(ethylene adipate), poly(ethylene glyocol) or
poly(propylenglycol).
[0034] An example yielding from MDI/1,4-butanediol as the hard
segment-forming phase and poly(.epsilon.-caprolactone) is
semi-crystalline linear block copolymers having shape memory effect
and a switching temperature of T.sub.m=44-55.degree. C. at a
molecular weight of from 1600 to 8000 g/mol. In contrast thereto,
linear shape-memory block copolymers having an amorphous phase and
a switching temperature of T.sub.g=-5 to 48.degree. C. from
MDI/1,4-butanediol as the hard segment-forming phase and flexible
poly(ethylene adipate) can have a molecular weight of from 300 to
2000 g/mol.
[0035] Alternatively to the embodiment in which the polymer
composite, of which the braiding of inventive medical occlusion
device is composed, exhibits a phase-segregated diblock copolymer,
it is provided for the polymer composite to exhibit a
phase-segregated triblock copolymer having a semi-crystalline
central B-block and two amorphous terminal A-blocks whereby the
A-blocks constitute the hard segment and the B-block establishes
the switching temperature.
[0036] It would be conceivable here for the polymer composite to
have semi-crystalline poly-(tetrahydrofuran) as the central B-block
and amorphous poly(2-methyloxazolin) as the terminal A-blocks.
[0037] Pursuant thereto, other shape memory polymers based on
linear block copolymers and which function according to the
above-described operating principle are the claimed
phase-segregated diblock or triblock copolymers, which would
include, for example, AB-block copolymers of 34 wt. % polystyrol
(PS) as the amorphous A-block and 66 wt. % poly(1,4-butadiene) (PB)
as the semi-crystallized B-block.
[0038] FIG. 5 shows the structure of such diblock or triblock
copolymers having shape memory effect. The glass transition of PS
is known to be 90.degree. C. and constitutes the hard
segment-forming phase. The melting temperature of the PB
crystallite serves as the switching temperature for the thermal
shape memory effect and is between 45 and 65.degree. C.
[0039] Another example likewise shown in FIG. 5 depicts ABA
triblock copolymers of semi-crystalline poly(tetrahydrofuran)
(PTHF) as the central B-block and amorphous poly(2-methyloxazolin)
(POX) as the terminal A-blocks. The A-blocks having an average
molecular weight of 1500 g/mol exhibit a glass transition
temperature of 80.degree. C. and constitute the hard segment. The
B-block having a molecular weight of between 4100 and 18800 g/mol
is semi-crystallized and melts between 20 and 40.degree. C.
depending upon the molecular weight. The switching temperature can
thus vary within this range.
[0040] Polymer compounds having polynorbornene,
polyethylene/nylon-6-graft copolymers and/or crosslinked
poly(ethylene-co-vinyl acetate) copolymers have been determined to
be advantageous with respect to the chemical composition of the
polymer composite used in the inventive medical occlusion
device.
[0041] Likewise proven to be advantageous is for the polymer
composite to exhibit a covalent crosslinked polymer network formed
by polymerization, polycondensation and/or polyaddition of
difunctional monomers or macromers with additive of tri or higher
functional crosslinking, whereby given an appropriate selection of
the monomers, their functionality and ratio of crosslinkers, the
chemical, thermal and mechanical properties of the polymer network
as formed can be specifically and selectively set. This thus
enables the precise and advance establishing of the properties for
the occlusion device at the transition from the first preliminary
definable profile shape to the second preliminary definable profile
shape, and in particular, the precise and advance establishing of
the course of events upon expansion of the occlusion device.
[0042] A particularly preferred implementation of the latter
embodiment provides for the polymer composite to be a covalent
polymer network which constitutes a crosslinker by crosslinking
copolymerization of stearylacrylate and methacrylic acid with
N,N'-methylenebisacrylamide, whereby the shape memory effect of the
polymer composite is based on crystallizing stearyl-side
chains.
[0043] It is likewise feasible for the polymer composite to exhibit
a covalent crosslinked polymer network which is formed by
subsequent crosslinking of linear or branched polymers.
[0044] Additionally conceivable here would be, for example,
activating the crosslinking by ionizing radiation or by thermal
fission of radical-forming groups.
[0045] Hence, a large group of shape-memory polymers constitute the
covalent crosslinked polymer networks as previously indicated at
the outset. Based on their structure, two different strategies for
synthesis are advantageously followed:
[0046] Polymerization, polycondensation or polyaddition of
difunctional monomers or macromers with additive of tri or higher
functional crosslinking. Given the appropriate selection of the
monomers, their functionality and the ratio of crosslinkers, the
chemical, thermal and mechanical properties of the polymer network
as formed can be specifically and selectively set.
[0047] A second synthesis variant for covalent shape-memory polymer
networks is given by the subsequent crosslinking of linear or
branched polymers. Cross-linking density is hereby heavily
dependent on the reaction conditions selected. Here, the
crosslinking is usually activated by ionizing radiation or by
thermal fission of radical-forming groups. For example,
polyethylene films receive heat-shrinking properties from radiating
polyethylene with .gamma.-steel or cross-linked
polyethylene-polyvinylacetate copolymers obtain shape memory effect
by homogenous addition of the dicumylperoxide radical
initiator.
[0048] FIG. 6 shows feasible monomers for covalent shape memory
polymer networks. Here, for example, covalent polymer networks have
shape memory effect obtained by crosslinked copolymerization of
stearylacrylate STA and methacrylic acid MAA with
N,N'-methylene-bisacrylamide MBA as the crosslinker, the shape
memory effect of which is based on the crystallizing stearyl-side
chains. Based on the relative stearylacrylate ratio, a melting or
switching temperature of between 35 and 50.degree. C. results.
[0049] It can be established in summary that both basic types of
shape memory polymers; i.e., thermoplastic elastomers and covalent
polymer networks, differ in their properties, their processing
methods and their programming procedures. The thermoplastic
elastomers need a minimum part by weight of hard segment-forming
polymer chains to ensure the physical crosslinks. In the case of
covalent networks, the ratio of hard segment-forming polymer chains
can be higher. It is, of course, conceivable for the described
shape memory polymers to find potential application across a wide
range of technologies, for example with respect to self-repairing
auto bodies, switching elements, sensors and right on up to smart
packaging.
[0050] Of particular interest with respect to the use of medical
occlusion devices are implant materials which are synthetically
biodegradable. Degradable materials, respectively polymers, have
bonds which are fissionable under physiological conditions.
Degradable-ness is the term used if a material decomposes from loss
of mechanical properties due to or within a biological system. An
implant's external form and dimensions may in fact remain intact
during the decomposition. What is meant with respect to degradation
time, provided no additional quantifying data is given, is the time
it takes for the complete loss of mechanical properties. Biostable
materials refer to materials which remain stable within biological
systems and which degrade at least only partially over the long
term.
[0051] The present invention provides for medical occlusion devices
of the type specified at the outset and in accordance with the
previously-cited preferred embodiments to consist of a braiding
which is synthesized from a polymer composite comprising at least
one bio-degradable material.
[0052] A particularly preferred implementation of the latter
embodiment provides for the polymer composite to exhibit a
hydrolytically degradable polymer, in particular poly(hydroxy
carboxylic acids) or the corresponding copolymers. Hydrolytic
degradation has the advantage that the rate at which degradation
occurs is independent of the site of implantation since water is
present throughout the system.
[0053] However, making use of enzymatically degradable polymers is
also conceivable in another embodiment. Feasible in particular is
that the polymer composite exhibit a biodegradable thermoplastic
amorphous polyurethane-copolyester polymer network.
[0054] Likewise requisite for the chemical composition to the
polymer composite for the inventive medical occlusion device is
that the polymer composite exhibit a biodegradable elastic polymer
network, obtained from crosslinking of oligomer diols with
diisocyanate.
[0055] Having polymer composites be formed as covalent networks
based on oligo(.epsilon.-caprolactone)dimethacrylate and
butylacrylate is a conceivable alternative thereto.
[0056] For the braiding from which the inventive occlusion device
is configured, the invention claims both hydrolytically as well as
enzymatically degradable polymer composites for the degradable
polymers. As stated above, hydrolytic degradation has the advantage
that the rate at which degradation occurs is independent of implant
location. In contrast, local enzyme concentrations vary greatly.
Given biodegradable polymers or materials, degradation can thus
occur through pure hydrolysis, enzymatically-induced reactions or
through a combination thereof.
[0057] Typical hydrolyzable chemical bonds for the polymer
composites of the occlusion device are amide, ester or acetal
bonds. Two mechanisms can be noted with respect to the actual
degradation. With surface degradation, the hydrolysis of chemical
bonds transpires exclusively at the surface. Because of the
hydrophobic character, polymer degradation is faster than the water
diffusion within the material. This mechanism is seen especially
with poly(anhydrides) and poly(orthoesters).
[0058] As relates to the poly(hydroxy carboxylic acids)
particularly significant especially to the present invention such
as poly(lactic acid) or poly(glycol acid), the corresponding
copolymers respectively, polymer degradation transpires throughout
the entire volume. The step which determines the rate here is the
hydrolytic fission of the bonds since water diffusion in the
somewhat hydrophilic polymer matrix occurs at a relatively fast
rate.
[0059] Decisive for the use of biodegradable polymers is that, on
the one hand, they degrade at a controlled or variable speed and,
on the other, that the products of decomposition are non-toxic.
[0060] The concept of polymer material resorption refers to the
substance or mass degrading through to the complete removal of a
material from the body by way of the natural metabolism. In the
case of homogenous implants (occlusion devices) of only one
degradable polymer, resorption begins as of that point in time of
the complete loss of the mechanical properties. Specification of
the resorption time covers the period starting from implantation
and running through to the complete elimination of the implant.
[0061] Among the most important biodegradable synthetic classes of
polymers from which the braiding of the inventive occlusion device
is advantageously synthesized are: [0062] polyesters such as
poly(lactic acid) PLA, poly(glycol acid) PGA, poly(3-hydroxybutyric
acid) PBA, poly(4-hydroxyvalerate acid) PVA or
poly(.epsilon.-caprolactone) PCL or the respective copolymers;
[0063] polyanhydrides synthesized from dicarboxylic acids such as,
for example, glutar PAG, amber PAB or sebacic acid PAS; [0064]
poly(amino acids) or polyamides such as, for example, poly(serine
ester) PSE or poly(aspartic acid) PAA (FIG. 9).
[0065] FIG. 7 shows examples of biodegradable polyesters while FIG.
8 shows examples of biodegradable polyanhydrides, poly(amino acids)
and polyamides.
[0066] In summary, it can be stated that shape memory properties
play a significant role with respect to implants, particularly in
terms of minimally invasive medicine. Degradable implants having
shape memory properties are particularly effective in this
regard.
[0067] For example, this type of degradable implant can be
introduced into the body in compressed (temporary) form through a
small incision and once in place, then assume the memory shape
relevant to its application after being warmed by the body
temperature. The implant will then degrade after a given interval
of time, thereby doing away with the need for a second operation to
remove it.
[0068] Based on the known biodegradable polymers, structural
elements can be derived for the synthesizing of biodegradable shape
memory polymers. In so doing, suitable crosslinks, which fix the
permanent form, and network chains, which serve as switching
elements, must be selected such that, on the on hand, the switching
temperature can be realized through the physiological conditions,
and on the other, toxicological problems with respect to any
products of decomposition are excluded. Thus, suitable switching
segments for biodegradable shape memory polymers can be selected
based on the thermal properties of known degradable implant
material. Of particular interest in this regard is a thermal
transition of the switching elements in the temperature range of
between room temperature and body temperature. For this transition
temperature range, biodegradable polymer segments can be
selectively synthesized by varying the stochiometric relationship
of the known starting monomers and the molecular weight of the
formed polymers in the range of from approx. 500 to 10000
g/mol.
[0069] Suitable polymer segments are e.g.
poly(.epsilon.-caprolactone)diols with melting temperatures between
46 and 64.degree. C. or amorphous copolyesters based on lactic and
glycol acid with glass transition temperatures between 35 and
50.degree. C. The phase transition temperatures hereby; i.e., the
melting or glass transition temperature of the polymer switching
segments, can be further diminished by their chain length or by
degradation of specific end groups. The polymer switching elements
thus customized can then be integrated into physical or covalent
crosslinked polymer networks, yielding the selectively composed
biodegradable shape-memory polymer material.
[0070] In one possible embodiment, biodegradable thermoplastic
amorphous polyurethane copolyester polymer networks having shape
memory properties are used as the material for the inventive
occlusion device. First, suitable biodegradable star-shaped
copolyester polyols are synthesized here based on commercially
available dilactide DL (cyclic lactic acid dimer), diglyocolide DG
(cyclic glycol acid dimer) and trimethylolpropane TP (functionality
F=3) or pentaerythrit PE (F=4) with glass transition temperatures
between 36 and 59.degree. C., which are then crosslinked with
commercial trimethylhexa-methylene diisocyanate TMDI in forming a
biodegradable polyurethane network.
[0071] FIG. 9 shows an example of monomer components for amorphous
polyurethane copolyester polymer networks having shape memory
properties.
[0072] The amorphous polyurethane copolyester polymer networks
having shape memory properties as formed have a glass transition
temperature T.sub.g between 48 and 66.degree. C. and exhibit a
modulus of elasticity in extension of between 330 and 600 MPa, a
tensile strength respectively of between 18.3 and 34.7 MPa. Heating
these networks to approximately 20.degree. C. above this switching
temperature yields elastic materials which can be deformed 50-265%
into a temporary shape. Cooling down to room temperature occasions
the forming of deformed shape memory polymer networks which have a
clearly higher modulus of elasticity in extension of from 770 to
5890 MPa. Upon subsequent reheating to 70.degree. C., the examples
of deformed specimens thereby produced retransform back into the
permanent corkscrew-like shape after approx. 300 s. What was
ultimately shown was that polyurethane copolyester polymer networks
in an aqueous phosphate buffer decomposed fully at 37.degree. C.
over a period of between approximately 80 and 150 days.
[0073] By optimizing the composition of the biodegradable switching
segments, degradable polyurethane copolyester polymer networks
having shape memory properties can be produced substantially
faster, e.g. within 14 days.
[0074] Similar biodegradable elastic shape memory polymer networks
can be yielded from crosslinking of oligomer diols with
diisocyanate TMDI which have melting temperatures between 38 and
85.degree. C. and which are likewise suitable for the inventive
occlusion device. Using these materials, a fiber was synthesized
and stretched 200% into a temporarily longer fiber and a loose knot
formed therefrom. After fixing the two ends of the knot and heating
the knot to 40.degree. C.; i.e., higher than the switching
temperature, the knot tightened itself again after approx. 20 s
into the semi-permanent length through the transition of the
thread. Degradableness was also ultimately assessed, whereby for
these polymers in an aqueous phosphate buffer at 37.degree. C., a
50% loss of mass was seen after approximately 250 days.
[0075] In one possible realization of the inventive occlusion
device, the braiding is formed from a biodegradable shape memory
polymer on covalent networks based on
oligo(.epsilon.-capro-lactone)dimethacrylate and butylacrylate. It
has been seen that subsequent subcutaneous implantation, this
polymer composite has no negative impacts on the wound healing
process. The synthesis of such biodegradable shape memory polymers
can follow from n-butylacrylate which, because of the low glass
transition temperature of -55.degree. C. for pure
poly(n-butylacrylate), can be used as the soft segment-forming
component.
[0076] FIG. 10 shows monomer components for covalent biodegradable
networks. The bio-degradable segments are introduced here via the
oligo(.epsilon.-caprolactone)dimethacrylate crosslinker. Network
synthesis ensues through photopolymerization. Based on the molar
mass of the macromolecular
oligo(.epsilon.-caprolactone)dimethacrylate and the content of
comonomer n-butylacrylate, the switching temperature and the
mechanical properties of the covalent network can be controlled.
Thus in an implementation of the inventive solution, the molar mass
of the oligo(.epsilon.-caprolactone)dimethacrylate varies between
2000 and 10000 g/mol and the n-butylacrylate content between 11 and
90 mass %. In the case of a polymer network based on a mixture of
the low molecular oligo(.epsilon.-caprolactone)-dimethacrylate at
11 mass % of n-butylacrylate, a melting point of 25.degree. C. was
realized.
[0077] The biodegradable covalent and physical polymer networks
having shape memory effect as described above can also be used as a
matrix for a controlled active substance release. Yet also
conceivable would be biodegradable polyurethane multiblock
copolymers having shape memory effect based on poly(p-dioxanone)
PDO as the hard segment and TMDI as the diisocyanate.
[0078] FIG. 11 shows polymer segments in biodegradable
poly(p-dioxanone)-polyurethane multi-block copolymers. The
combination with the poly(lactid-co-glycolid) PDLG or
poly(.epsilon.-caprolactone) PCL switching segments yields
multiblock copolymers having a switching temperature of 37 or
42.degree. C. respectively. The hydrolytic degrading of the
polymers shows that the polymers based on PCL degrading at a lesser
rate. In a trial on the PCL polymers, 50 to 90% of the initial mass
was still present after 266 days of hydrolysis while in the case of
the PDLG polymers, 14 to 26% was detectable after only just 210
days.
[0079] It can be maintained that biodegradable shape memory polymer
networks can be synthesized from a combination of physical or
covalent shape memory polymer networks having biodegradable polymer
segments. Selectively choosing the components allows setting
optimal parameters for each respective application such as the
mechanical properties, the deformability, the phase transition
temperatures and, above all, the switching temperature, as well as
the rate of polymer decomposition.
[0080] With respect to the profile form to the inventive medical
occlusion device, it is advantageously provided for the second
preliminarily definable shape of the occlusion device to be
configured to close an abnormal tissue opening in a patient's
heart, whereby in its expanded state, the occlusion device exhibits
a proximal retention area, a distal retention area and a center
section between the two, and in which the occlusion device exhibits
a smaller diameter at the center segment than at the proximal
and/or distal retention areas. The advantage to this embodiment is
in particular seen in that an intravascular occlusion device is
provided which is particularly applicable to treating septal
defects, patent foramen ovale defects and persistent ductus
arteriosus defects and in which the occlusion device can be
introduced to the defect to be occluded by means of a catheter
system.
[0081] Septal defects refer to atrial septal defects (ASD); i.e., a
hole in the heart's interatrial partition, and ventricular septal
defects (VSD); i.e., a hole in the interventricular partition.
[0082] A patent foramen ovale defect (PFO) is an oval opening
(slit) in the interatrial partition of the heart which is normally
closed after birth by adhesion of the flap-like edges, although
imperfect adhesion (persistence) occurs in approximately 25% of all
births, leaving an open foramen oval.
[0083] The term "persistent ductus arteriosus defect" (PDA) refers
to an open passageway between the aorta and the pulmonary artery,
one which normally closes after birth.
[0084] The main objective of the present invention is to provide a
reliable, simple occluding device to be used in the heart which is
configured so as to be able to treat patent foramen oval defects
(PFO), atrial septal defects (ASD), ventricular septal defects
(VSD) and patent ductus arteriosus (PDA) and to do so in a form in
which the braiding--as already described above--is replaced by that
of a shape memory polymer or biologically degradable shape memory
polymer.
[0085] In configuring the second preliminarily definable shape to
the medical occlusion device from the braiding composed of a
polymer, there is a plurality of flexible strands or threads,
whereby the threads are braided in such a way so as to produce an
elastic material. This braided fabric is then deformed so that it
will conform to the outer surface of a molding element. The braided
fabric is positioned on the surface of the molding element and
subject to thermal treatment at increased temperature. The duration
and temperature for the thermal treatment is selected so as to
retain the deformation to the braided fabric. Subsequent the
thermal treatment, the braided fabric is removed from the molding
element, retaining its deformation. A braided fabric treated in
this way corresponds to the second preliminarily defined (expanded)
shape to the medical occlusion device which can be introduced into
a channel in the patient in collapsed state by means of a catheter
system.
[0086] Types of application for the present invention include
special shapes for medical devices, which can then be made in
accordance with the present invention in order to be used in
specific medical cases. The devices, having a flat expanded shape
and which can be disposed with collapsed clamps, can be attached to
an end of the insertion device or guidewire in order to retract the
device after positioning. In use, a catheter is introduced into the
body of the patient to the point where the distal end of the
catheter positions exactly at the location which is in need of
physiological treatment. A medical device previously selected in
accordance with the present invention is then collapsed into a
preliminarily defined second shape and inserted into the catheter
opening. The device is pushed through the catheter and exits again
at its distal end where, due to its memory properties, springs back
into its original shape next to the site to be treated. The
guidewire or inserting catheter then releases from the clamp and is
retracted.
[0087] In its second preliminarily defined shape, the occlusion
device preferentially exhibits an oblong shape with a tube as its
center section and an expanded diameter segment at each end of said
center section. The thickness to the center section corresponds
roughly to the wall thickness of the organ to be occluded, for
example the thickness of the septum.
[0088] The center of at least one expanded diameter segment
(proximal or distal retention area), can be offset relative the
center of the center section. A membranous ventricular septal
defect can thus be closed with simultaneous application of a
support device large enough to reliably close the abnormal opening
of the septum. Each braided end of the device is held by a clamp.
These clamps are retracted in the expanded diameter parts of the
device, whereby the overall length of the device is reduced and a
more flush closure mechanism is yielded.
[0089] In another type of application, the device takes on the
appearance of a bell having an oblong body with a tapered and a
larger endpiece. The larger end has a fabric plate which upon
unfolding, positions generally perpendicular the axis of the
channel in which the device unfolds. The clamps holding the braided
ends together retract into the center of the "bell" and thus yield
a flush device having lower overall height.
[0090] Since the proximal retention area of the braiding exhibits a
flaring toward the proximal end of the occlusion device in a
particularly preferred embodiment, this allows for the occlusion
device to adjust automatically to the septal defect in particularly
advantageous manner--independent of the relative diameter of the
defect to be occluded and independent of the thickness of the
septal wall--and to do so with no part of the occlusion device
projecting beyond the plane of the septal wall with the defect at
the proximal side of the defect. There is thus no occurrence of the
usual complications which normally arise in such cases. To
emphasize, this means that the occlusion device used is ingrown by
the body's own tissue substantially faster than is the case with
the occluding systems known in the prior art. Using a braiding
composed of thin threads as the starting material for the inventive
occlusion device yields the further advantage of long-term
mechanical stability. This thus largely prevents structural
fractures in the inserted implant. In addition, the braiding is
afforded sufficient rigidity. The flaring to the proximal end of
the braiding's proximal retention area additionally allows the
proximal retention area of the device to flatten completely against
the lateral edge of the defect in the inserted state and to do so
virtually independently of the diameter to the defect or the
thickness of the septal wall. As a result, the occlusion device can
be used for a wide range of differently sized septal defects.
Because there is then no need for a holder for the bundled or
merging braiding at the proximal retention area, neither do any
components of the occlusion device protrude past the septum wall,
which prevents components of the implant from being in constant
contact with the blood. This yields the advantage of there being no
threat that the body will mount defense mechanism reactions or of
there being thrombembolic complications.
[0091] A particular preferred embodiment provides for the center of
the proximal/distal retention area to be offset relative the center
of the center segment. By so doing, a membranous ventricular septal
defect can be occluded and, at the same time, a support device can
be used which is large enough to close the abnormal opening in the
septum.
[0092] Thereto, it can be provided that each braided end of the
occlusion device be held by a clamp. These clamps are withdrawn
from the occlusion device's expanded diameter parts (proximal and
distal retention areas), yielding a reduced overall length to the
occlusion device and a more flush closure mechanism.
[0093] One advantageous embodiment provides for the interior of the
proximal and/or distal retention area to exhibit a concave profile
form in the second preliminarily definable shape of the occlusion
device in the expanded state. This allows the expanded occlusion
device to attain an especially good positioning in the defect to be
occluded. It is particularly preferred for the braiding from which
the occlusion device is produced to be tapered in a first
preliminarily definable shape to the diameter of the catheter
system used in the intravascular procedure. This thus enables the
occlusion device for occluding a defect to be inserted with a
catheter introduced, for example, through a vein, eliminating the
need for an operation in the actual sense. When the braiding
includes a shape-memory polymer material, as described above, the
occlusion device tapered to the diameter of the catheter is known
as a "self-expanding device" which unfolds automatically upon
exiting the catheter such that the two retention areas can position
accordingly at the proximal/distal sides of the defect. The design
to the contiguous braiding of the inventive occlusion device
moreover occasions an occlusion device which is a self-expanding
and self-positioning occluding system which prevents permanent
mechanical stress from occurring between the inserted occlusion
device and the septum wall. Provided as a conceivable
implementation is that the proximal retention area of the braiding
exhibit a bell-shaped flaring toward the proximal end.
[0094] It would furthermore be conceivable for the proximal
retention area to exhibit a bell-shaped flaring to the proximal
end. This would thus allow the occlusion device to be used in the
treatment of various different defects, in particular ventricular
septal defects (VSD), atrioseptal defects (ASD) as well as
persistent ductus arteriosus Botalli (PDA), whereby an optimized
contouring to the proximal retention area can in principle be
selected for a plurality of defects of differing sizes and types.
Of course, other profiles are also conceivable in this regard such
as, for example, a barbell-like shape. In order to enable a
particularly good positioning of the expanded occlusion device at
the retention area, it is advantageously provided for the length of
the center section to be dimensioned such that the peripheral edge
of the distal or proximal retention area overlaps the peripheral
edge of the other retention area.
[0095] A particularly preferred embodiment of the inventive
occlusion device provides for the proximal and/or distal retention
area to exhibit a recess in which the holder for bundling the ends
of the braiding is disposed. By arranging the holder in the recess
provided at the proximal or distal end of the occlusion device, no
components of the occlusion device will protrude beyond the septum
wall, preventing the components of the implant from coming into
constant contact with the blood. This has the advantage of there
being no threat that the body will mount defense mechanism
reactions or of there being thrombembolic complications. Especially
because the expanded occlusion device positions and fixes itself in
the defect with the distal and proximal retention areas being
radially stressed, the occlusion device can be used for a wide
range of defects of various hole sizes.
[0096] A particularly preferred embodiment of the inventive
occlusion device in which the distal retention area exhibits a
recess further provides for the distal end of the occlusion device
to be further disposed with a connective element in the recess,
whereby said connective element can engage with a catheter. This
connective element, which is arranged on the occlusion device so as
not to protrude beyond the septum wall such that no components of
the implant come into constant contact with the blood, provides the
inventive occlusion device with the added functionality of
retrievability. Moreover, a connective element which can engage
with a catheter facilitates implantation and positioning of the
occlusion device (collapsed during the actual implanting) in the
defect to be occluded. Various devices are conceivable as
connective elements. For example, latching members would be
feasible, as would even be hooks/eyelets which force-fit with the
correspondingly configured complementary connective elements of a
catheter.
[0097] Another advantageous embodiment provides for the occlusion
device to be configured so as to be reversibly collapsible inward
and outward so that the device can be collapsed in its expanded
state, for example with the help of an explantation catheter. In
conjunction hereto, it is conceivable for a catheter in the
explantation procedure to, for example, engage with connective
elements configured at the distal end of the occlusion device and
occasion the collapsing of the occlusion device in response to
external manipulation of the catheter. The occlusion device is
thereby fully reversibly retractable in the catheter, enabling the
complete removal of the device.
[0098] Last but not least, it is particularly preferred for the
occlusion device to have at least one fabric insert disposed in or
on the distal retention area or in the center section of the
occlusion device to occasion complete closure of a defect. This
fabric insert serves to close the gaps which remain in the center
section and in the expanding diameters of the occlusion device
following insertion and expansion of the device in the defect to be
occluded. The fabric insert is, for example, affixed to the
braiding of the occlusion device at the distal retention area such
that it can be stretched over the distal retention area like a
cloth. The advantage to this design lies in the fact that the
lateral edge of the distal retention area is flush with the septum
and less foreign material is introduced into the body of the
patient. The fabric inserts can be made of, for example, Dacron.
Other materials and other positionings to the fabric insert in or
on the occlusion device are of course also conceivable here.
[0099] There has thus been outlined, rather broadly, some features
consistent with the present invention in order that the detailed
description thereof that follows may be better understood, and in
order that the present contribution to the art may be better
appreciated. There are, of course, additional features consistent
with the present invention that will be described below and which
will form the subject matter of the claims appended hereto.
[0100] In this respect, before explaining at least one embodiment
consistent with the present invention in detail, it is to be
understood that the invention is not limited in its application to
the details of construction and to the arrangements of the
components set forth in the following description or illustrated in
the drawings. Methods and apparatuses consistent with the present
invention are capable of other embodiments and of being practiced
and carried out in various ways. Also, it is to be understood that
the phraseology and terminology employed herein, as well as the
abstract included below, are for the purpose of description and
should not be regarded as limiting.
[0101] As such, those skilled in the art will appreciate that the
conception upon which this disclosure is based may readily be
utilized as a basis for the designing of other structures, methods
and systems for carrying out the several purposes of the present
invention. It is important, therefore, that the claims be regarded
as including such equivalent constructions insofar as they do not
depart from the spirit and scope of the methods and apparatuses
consistent with the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0102] The following will make reference to the drawings in
providing a more precise detailing of preferred embodiments of the
inventive occlusion device.
[0103] FIG. 1 is a schematic representation of the shape memory
effect;
[0104] FIG. 2 is a schematic representation of the molecular
mechanisms which occur upon shape-memory transition of a
semi-crystalline polymer network;
[0105] FIG. 3 depicts a synthesis diagram of thermoplastic
polyurethane multiblock copolymers;
[0106] FIG. 4 depicts the chemical structure to monomer components
of thermoplastic polyurethane multiblock copolymers;
[0107] FIG. 5 depicts the structure to diblock or triblock
copolymers having shape-memory effect;
[0108] FIG. 6 is a representation of monomers for covalent shape
memory polymer networks;
[0109] FIG. 7 depicts examples of biodegradable polyesters;
[0110] FIG. 8 depicts examples of biodegradable polyanhydrides,
poly(amino acids) and polyamides;
[0111] FIG. 9 depicts monomer components for amorphous polyurethane
copolyester polymer networks having shape memory properties;
[0112] FIG. 10 depicts monomer components for covalent
biodegradable networks;
[0113] FIG. 11 depicts polymer segments in biodegradable
poly(p-dioxanone)-polyurethane multiblock copolymers;
[0114] FIGS. 12a, b depict a side and stereoscopic view of a Type 1
PFO occlusion device; FIGS. 13a, b are a stereoscopic
representation of a Type 1 PFO occlusion device;
[0115] FIG. 14 depicts a side view of a Type 2 PFO occlusion
device;
[0116] FIG. 15 depicts a side view of a Type 3 PFO occlusion
device;
[0117] FIG. 16 depicts a top plan view of a Type 3 PFO occlusion
device;
[0118] FIGS. 17a, b depict a conventionalized side view and
sectional representation of a Type 4 PFO occlusion device;
[0119] FIG. 18a depicts an enlarged detail view of a section as
seen through a Type 1 occlusion device (Type 1 ASD occlusion
device) for occluding an atrial septal defect(ASD); the occlusion
device is elongated and extends partially out of the opening of an
inserting catheter;
[0120] FIG. 18b depicts an enlarged detail view of a section as
seen through a Type 2 occlusion device in a conventional
embodiment;
[0121] FIG. 18c depicts an enlarged detail view of a section as
seen through a Type 3 ASD occlusion device with polymer threads
thermally bundled in the left atrial curve;
[0122] FIG. 18d depicts an enlarged detail view of a section as
seen through a Type 4 ASD occlusion device having a type of
braiding comparable to that of Type 1 (FIGS. 19-21);
[0123] FIG. 19a depicts a frontal view of the Type 1 ASD occlusion
device pursuant FIG. 18a in its pre-formed shape;
[0124] FIG. 19b depicts the ASD occlusion device pursuant FIG. 19a
in slightly elongated form;
[0125] FIG. 19c depicts a side view of the ASD occlusion device
pursuant FIG. 19a in further elongated form;
[0126] FIG. 20a depicts a frontal view of a Type 2 ASD occlusion
device pursuant FIG. 18b in its pre-formed shape;
[0127] FIG. 20b depicts the ASD occlusion device pursuant FIG. 20a
in slightly elongated form;
[0128] FIG. 20c depicts the ASD occlusion device pursuant FIG. 20a
in further elongated form;
[0129] FIG. 21a depicts a frontal view of a Type 3 ASD occlusion
device pursuant FIG. 18c in its pre-formed shape;
[0130] FIG. 21b depicts a side view of the ASD occlusion device
pursuant FIG. 21a in slightly elongated form;
[0131] FIG. 21c depicts a side view of the ASD occlusion device
pursuant FIG. 21a in further elongated form;
[0132] FIG. 22a depicts a frontal view of the Type 4 ASD occlusion
device pursuant FIG. 18d in its pre-formed shape;
[0133] FIG. 22b depicts a side view of the ASD occlusion device
pursuant FIG. 22a in slightly elongated form;
[0134] FIG. 22c depicts a side view of the ASD occlusion device
pursuant FIG. 22a in slightly further elongated form;
[0135] FIG. 23 depicts a detailed view of a section as seen through
the side of an ASD occlusion device pursuant FIG. 21 in the ASD of
a heart;
[0136] FIG. 24 depicts an enlarged frontal view of an occlusion
device for occluding a VSD in its pre-formed shape;
[0137] FIG. 25 depicts a side view of the VSD occlusion device
pursuant FIG. 24;
[0138] FIG. 26 depicts a detail view of a section as seen through
the front of the VSD occlusion device pursuant FIG. 24;
[0139] FIG. 27 depicts a surface depiction from above of the VSD
occlusion device pursuant FIG. 24;
[0140] FIG. 28 depicts a surface depiction from below of the VSD
occlusion device pursuant FIG. 24;
[0141] FIG. 29 depicts an enlarged frontal view of another VSD
occlusion device in its pre-formed shape;
[0142] FIG. 30 depicts a detail view of a section as seen through
the side of the VSD occlusion device pursuant FIG. 29;
[0143] FIG. 31 depicts an enlarged frontal view of another VSD
occlusion device in its pre-formed shape;
[0144] FIG. 32 depicts a detail view of a section as seen through
the side of the VSD occlusion device pursuant FIG. 31;
[0145] FIG. 33 depicts an enlarged frontal view of another VSD or
PDA occlusion device in its pre-formed shape;
[0146] FIG. 34 depicts a detailed view of a section as seen through
the side of the VSD or PDA occlusion device pursuant FIG. 33;
[0147] FIG. 35 depicts a perspective view of a medical occlusion
device in accordance with the present invention;
[0148] FIG. 36 depicts a side view of the occlusion device pursuant
FIG. 35;
[0149] FIG. 37 depicts a top plan view of the occlusion device
pursuant FIG. 35;
[0150] FIG. 38 depicts a partial sectional view through a molding
element used for shaping the occlusion device pursuant FIG. 35;
[0151] FIG. 39 depicts a perspective view of a medical occlusion
device in accordance with the present invention without the
associated sleeve in the proximal area as in the occlusion device
pursuant FIG. 35;
[0152] FIG. 40 depicts a perspective detail view of a section
through the heart with the occlusion device pursuant FIG. 35
unfolded in a central shunt of the patient's blood vessel;
[0153] FIG. 41 depicts an enlarged frontal view of an occlusion
device used in the occluding of a PDA;
[0154] FIG. 42 depicts a detail view of a section through the PDA
occlusion device pursuant FIG. 41;
[0155] FIG. 43 depicts a top plan view of the PDA occlusion device
pursuant FIG. 41;
[0156] FIG. 44 depicts a plan view from below of the PDA occlusion
device pursuant FIG. 41; and
[0157] FIG. 45 depicts a PDA occlusion device within an insertion
catheter.
DESCRIPTION OF THE INVENTION
[0158] The present invention relates to a percutaneous
catheter-guided occlusion device which serves to close abnormal
openings such as, for example, atrial septal defects (ASD, PFO),
ventricular septal defects (VSD), patent ductus arteriosus (PDA)
and the like. The present invention furthermore provides for a
method of forming a medical device from a flat or tubular synthetic
or polymer fabric. Both the flat as well as the tubular fabric is
comprised of a plurality of wire strands having a predefined
relative arrangement to one another. The tubular fabric has
synthetic strands distinguishing two sets of essentially parallel
spiral strands, whereby the strands of one set have a rotation
direction counter to that of the other strands. This fabric is also
known in the industry as a tubular braid.
[0159] The braided form is used primarily in Type 2 (FIG. 14) and
Type 3 (FIG. 15) PFO devices, whereby the wires/threads of the
proximal curves are thermally bundled at proximal end 2 and
specifically in an element which is designated as a "thermal
holder." Thermal energy acts here to fuse the wires together.
[0160] The tubular fabric 10 is used in comparable manner in the
Type 2 ASD (FIG. 18b, and FIGS. 20a-20c) and Type 3 devices (FIG.
18c, FIGS. 21a-21c) in addition to the VSD types of devices (FIG.
24, FIG. 25, FIG. 26), the type of device in accordance with FIGS.
35 and 39, and last but not least, the PDA device in accordance
with FIG. 41.
[0161] Using the braiding method as developed by JEN.meditec GmbH
in accordance with the Aug. 22, 2003 German patent application No.
10 338 702 as cited at the outset yields additional preferable
forms of the device which are particularly economical in terms of
material and the method used to produce such braided material
enables the PFO and ASD devices to have flatter final forms. The
medical devices produced with this braiding method comprise the
PFO, Type 1 (FIG. 12a, b and FIG. 13a, b) and Type 4 (FIG. 17a, b)
types of devices and the ASD Type 1 (FIG. 18a, FIG. 19a-19c) and
Type 4 (FIG. 18d, FIG. 22a-22c) types of devices.
[0162] The pitch to the synthetic strands and the pick (i.e., the
number of turns per unit length) as well as other factors such as
the number of wires used in the tubular braiding are essential in
defining a number of important properties for the device. The
tighter the pick and the pitch of fabric 10, meaning the closer the
synthetic strands are woven to one another, the more rigid the
device. A greater wire density means a larger wire surface, thus
increasing the device's occluding ability. Such thrombogenicity can
either be increased, e.g. by coating with a thrombolytic agent, or
decreased, e.g. by means of a lubricious anti-thrombogenic
coating.
[0163] In the forming of device 1 in accordance with the present
invention, a tubular or flat synthetic fabric 10 of corresponding
size is inserted into a mold in which the fabric 10 conforms to the
cavities of the mold. These cavities are configured such that the
synthetic fabric 10 assumes the shape of the desired device. The
ends of the synthetic strands of the tubular or flat synthetic
fabric 10 should be secured in order to prevent fraying. A clamp
can be used to this end (e.g. Type 2 PFO and ASD devices as
described above) or the ends of the synthetic strands can be
thermally treated, for example welded (e.g. Type 3 PFO and ASD
devices).
[0164] In the case of a tubular braiding, a molding element can be
inserted into the tube of the braiding prior to the braiding being
inserted into the mold. This occasions an even more precise
defining of the molded surface. When the ends of the tubular
synthetic fabric have been clamped or welded, the molding element
can be introduced into the tube manually by bending apart the
synthetic strands of fabric 10. This type of molding element serves
to provide a very precise control over the final size and shape of
the device by ensuring that the fabric conforms to the cavities of
the mold.
[0165] A material can be selected for the molding element which can
be broken into smaller pieces or removed from the inside of the
synthetic fabric. The molding element can thus, for example, be
made from a brittle or friable material. After thermally treating
the material with the molding element in the mold cavity, the
molding element is broken into small pieces easily removed from the
synthetic fabric.
[0166] Usually, however, molding tools (molding elements) can be
used for all the medical devices described here which precisely
define the shape of the medical devices based on an outer sleeve
(fractionable into different individual pieces). Since the medical
devices are made from synthetic material having a melting point
below 350.degree. C., the molding elements of the molding tool can
be made of aluminum, tool steel, non-ferrous metal or even titanium
or titanium alloys.
[0167] It is, however, to be pointed out that the specific form of
a particular molding element will yield a specific shape and that
other molding elements having other configurations can also be used
as desired. If a complex shape is desired, molding elements and
molds can have additional components, including cammed connections.
For simpler shapes, the mold can also have fewer components. The
number of components in a given mold and their shape depend almost
exclusively on the shape of the desired device to which the
synthetic fabric will conform. In its relaxed state, the synthetic
strands of the tubular braiding assume a previously-defined
orientation relative one another. When the tubular braiding is
compressed along its axis, the fabric pitches away from the axis in
expanding according to the shape of the mold. In deformed fabric,
the relative orientation to the wire strands of the synthetic
fabric changes. Compressing the mold occasions the synthetic fabric
to conform to the surface of the cavity. The device has a
pre-determined expanded configuration and collapsed configuration
so that it can be introduced by means of a catheter or such similar
inserting device. The expanded configuration is a function of the
shape of the fabric after having been formed to the surface of the
mold.
[0168] Once the tubular or flat synthetic fabric has been inserted
into the selected mold, whereby the fabric is flush against the
surface of the mold's cavity, thermal treatment then follows with
fabric 10 thereby remaining in the mold. The wire strands of the
synthetic fabric are re-aligned and re-formed relative one another
by the thermal treatment, whereby the fabric conforms to the mold.
The fabric is then removed from the mold and retains the given
shape of the surface of the mold's cavity, now constituting the
desired device. The thermal treatment depends to a large extent on
the specific material from which the wire strands of the synthetic
fabric are made, yet duration and temperature for the thermal
treatment should be selected such that the fabric is fixed in its
new shape; i.e., the wire strands assume their relative
re-orientation subsequent the fabric conforming to the surface of
the mold.
[0169] After being thermally treated, the fabric is removed from
the molding element and retains its new form. In those cases where
a molding element has been used, same is now removed again as
described above. The duration of and temperature for the thermal
treatment depends heavily on the material composition to the wire
strands and has already been described in detail above.
[0170] After device 1 has been brought into the previously
specified form, it can be used for treating a patient. A device is
selected based on its being suitable for treating the respective
medical problem. Such a device is to be consistent with one of the
above-described types of application. Once the corresponding device
is selected, a catheter or other inserting device is introduced
into the patient and positioned such that the distal end of the
inserting device positions next to the site to be treated, e.g.
thus directly adjacent to (or at the same height of) a shunt of an
abnormal opening in an organ.
[0171] Insertion devices can be of various shapes but should,
however, preferably comprise a pliable metal shaft with threading
at its distal end. The insertion device hereby serves in pushing
the medical device through the tube of the catheter and positioning
it in the patient. When the device is pushed out the distal end of
the catheter, it is thus still being held. Not until the device is
positioned within the shunt of the abnormal opening is the shaft of
the catheter rotated about its axis in order to unscrew the device
from the catheter.
[0172] As long as the device is still connected to the catheter,
the surgeon can move the device forward and backward relative the
abnormal opening until that point at which it is exactly positioned
as desired within the shunt. Using a threaded clamp, as attached to
the device, the surgeon can control the movement of the device out
the distal end of the catheter. Once device 1 has been pushed out
of the catheter, it will spring back into the expanded form it
assumes in consequence of the fabric having been thermally treated.
At that moment at which it springs back into its original form, it
may happen that it impacts the distal end of the catheter and is
thereby urged forward. This can result in an incorrect seating of
the device, especially critical if same is to be positioned in a
shunt between two blood vessels. The surgeon can keep hold of the
device during its positioning by means of the threaded clamp; the
device will not spring out uncontrollably and can be positioned
accurately.
[0173] The device is collapsed and inserted into the opening of the
catheter. The collapsed form of the device should be such that it
can be easily inserted into the tube of the catheter and can
withdraw correctly at the distal end of same. Thus an ASD occluding
device can, for example, have a relatively oblong collapsed form,
whereby the individual components are disposed along the axis (see
FIGS. 18a-18d)). This can be attained in that one pulls the device
in opposite directions along its axis by e.g. manually holding the
clamps and pulling apart so that the expanded diameter segments
fold inward toward the axis.
[0174] The PDA occluding device also functions in similar fashion.
It can also be collapsed to allow insertion into a catheter by
stretching it along its axis (see FIG. 45), as it folds into itself
when pulled in opposite directions.
[0175] If the device is to serve to permanently close a channel in
a patient, the catheter is simply pulled out. The device remains in
the patient's vascular system to close the blood vessel or the
respective channel. In some cases, the device can be affixed to an
inserting system such that the device is fixedly connected to the
end of the insertion device. Before the catheter can be removed
from such a system, it may be necessary to unhook the medical
device from the insertion device prior to withdrawing the catheter
and insertion device.
[0176] Although the device springs back into its original expanded
shape (i.e., the form which it held before it was collapsed so as
to enable its insertion into the catheter), it must be made clear
here that it does not always assume its original shape in full
measure. It can thus be desirable, for example, for the device to
have a maximum outer diameter in its expanded shape which is at
least as large and preferably larger than the inner diameter of the
lumen of the abnormal opening at which it is to be affixed. When
such a device is fit to a blood vessel or an abnormal opening
having a small lumen, it expands until it fills out the lumen. When
doing so, it can thereby happen that the device will not have the
need to expand fully into its original expanded shape. It is
nevertheless properly affixed because it shuts off the inner wall
of lumen and remains fixed there.
[0177] When the device is deployed in a patient, thrombi form on
the surface of the wires. In the case of greater wire density, the
total surface area of the wires is increased such that the
thrombotic activity at the device also increases and the blood
vessel in which it is affixed closes at a relatively fast rate.
Should it be desired to accelerate the occluding time, a number of
thrombotic means can be disposed on the device.
[0178] The devices (occlusion devices 1) in accordance with FIGS.
12-17 are introduced in order to close defects such as the
so-called patent foramen ovale (PFO). With the Type 1 to 4 PFO
variants depicted here (exclusively synthetic fibers), cases of
critical defects can also be treated at the locality. A detailed
description of a Type 1 PFO occluder configured from nitinol
material can be found in the previously-cited Aug. 22, 2003
JEN.meditec patent application Ser. No. 10/338,702.
[0179] FIGS. 18-22 show a further form of application for the
present devices (occlusion devices 1), with which atrial septal
defects (ASD) can be corrected. The devices (occlusion devices 1)
shown in FIGS. 19-22 are a depiction of frames of the Type 1-4 ASD
devices in their relaxed, unexpanded state through to partially
expanded state.
[0180] ASD is a congenital anomaly of the atrial septal resulting
from a structural weakness of the interatrial septum. There can be
a shunt in the interatrial septum through which the blood flows
from the right into the left atrium. When there is a large defect
with significant shunts from left to right through the defect, the
right atrium and the right ventricle overflow and the excess
empties into a pulmonary vessel of low resistance.
[0181] Pulmonary vessel closure and pulmonary atrial hypertension
develop in adults. Patients suffering secondary ASD with a
considerable shunt (the ratio of the pulmonary blood flow to the
blood flow of the system being greater than 1.5) are preferably
operated on at the age of 5 or as soon as the diagnosis is made in
later life. With the advent of two-dimensional echocardiography and
Doppler color flow mapping, the exact anatomy of the defect can be
visualized. The appropriate ASD device is selected based on the
size of the defect.
[0182] The size of the ASD occluder valve is proportional to the
size of the shunt to be occluded. In its relaxed state, the
synthetic fabric is shaped such that two plate-like members,
retention areas 2 and 3 (FIG. 19a) respectively, are in axial
alignment and connected to a short cylindrical segment, or center
section 4, respectively. The length of cylindrical segment 4 is to
correspond to the thickness of the interatrial partition; i.e., 2
to 20 mm thick. Proximal plate 2 and distal plate 3 have an outer
diameter which is much larger than the shunt so as to exclude any
slippage of device 1. Proximal plate 2 is relatively flat while
distal plate 3 is curved toward the proximal end such that it
overlaps proximal plate 2 to some degree. Given the above, the
springing open of device 1 presses the peripheral edge of distal
plate 3 flush with the side wall of the septum. The outer edge of
proximal plate 2 is pressed against the septum's opposite side wall
in like manner.
[0183] The ends of device 1, made of metal tubular braiding fabric
10, are welded or clamped to holder 5, similar to the clamps as
described above, to prevent fraying. Holder 5, which holds the wire
strands together at an end, also serves in connecting the device to
the inserting system (see FIG. 18). In the application as shown,
the generally cylindrical holder 5 has a recess for the ends of the
metal fabric so that the wires of the braided fabric 10 cannot
shift relative one another. A threading is disposed in the recess
of holder 5, configured such that it can receive and hold the
distal end of an insertion system.
[0184] ASD occluder device 1 can be advantageously produced as a
form of application for the present invention using the method
specified above.
[0185] FIG. 23 depicts a detail sectional view through the side of
the ASD occluder of FIG. 21 in the ASD of a heart.
[0186] FIGS. 24-28 show different variants of an occluder device,
preferably used in cases of membranous VSD. In their preset form,
these devices 1 have two expanded diameter sections (retention
areas) 2 and 3 with a smaller diameter segment (center section) 4
disposed between said two expanded diameter sections 2 and 3. Each
expanded diameter section 2 and 3 is disposed with a recess
projecting inwardly from the outer surface of expanded diameter
sections 2 and 3. A clamp 7 is provided in the recesses at each end
of the tubular synthetic fabric 10.
[0187] The smaller diameter segment (center section) 4 has a length
which corresponds to the thickness of the abnormal opening in the
septum wall. The VSD device can be deformed in its expanded preset
form, thereby reducing its cross-section, so that it can be
introduced through a channel in the body as described above. The
inner surfaces of the expanded diameter sections can be concave or
curved so that the outer periphery will come into contact with each
diameter section given in the septum.
[0188] At least one diameter section 2 or 3 can also be arranged to
be offset relative the smaller diameter section 4. In the case of
abnormal openings adjacent the aorta, this thus prevents the offset
support device or the expanded diameter sections 2 and 3 from
closing off the aorta after insertion.
[0189] FIGS. 29 and 30 show a VSD device 1 in which the center of
both expanded diameter sections 2 and 3 and the smaller diameter
section 4 are along one line. Clamps (not explicitly shown) are
affixed to the ends of synthetic fabric 10 and pulled inwardly in
order to yield a flat occluding device. The clamps can have an
inner or outer threading for the fastening of an inserting device
or guidewire. This type of VSD device 1 is preferably used to close
muscular ventricular septum defects. The VSD device is inserted as
described above.
[0190] FIGS. 31 and 32 show another form of application for device
1 in the closing of a VSD. The device pursuant FIG. 32, while
similar to the VSD device of FIGS. 29 and 30, does have a few
differences: the length of the smaller diameter section 4 has been
reduced and both expanded diameter sections 2 and 3 have been
compressed in order to reduce the thickness of each diameter
section.
[0191] FIGS. 33 and 34 show another form of application for a
device 1 which is similar to that as depicted in FIGS. 31 and 32.
The device pursuant FIGS. 33 and 34 can occlude a patent ductus
arteriosus (PDA) in which the patient is suffering from pulmonary
hypertension. Both expanded diameter sections 2 and 3 are formed
with a thin cross-section so as not to hinder the flow of fluid
through the pulmonary vein or the aorta. In addition, the smaller
diameter section 4 tapers to a point in order to increase the
fabric contact area around the defect.
[0192] PDA is essentially the condition in which two blood vessels,
usually the aorta and the pulmonary artery near the heart, present
with a shunt between their two lumen. In this condition, blood will
flow from one blood vessel to the other directly through the shunt,
obstructing the patient's normal bloodstream flow. The PDA device
in accordance with FIG. 35 and FIGS. 36-37 has a bell-shaped body 3
and a forward section 2 projecting outwardly. The bell-shaped body
3 is adapted for affixing to the shunt between the blood vessels
while the forward section 2 is adapted for positioning in the aorta
in order to hold the body of the device in the shunt. The size of
body 3 and end 2 can be matched to the respective size of the shunt
as desired. Body 3 can thus have, e.g., in its generally thin
center section, a diameter of approximately 10 mm with a length to
its axis of approximately 25 mm.
[0193] The base of the PDA device body is to extend radially to the
outer diameter of forward section 2, which has a diameter on an
order of magnitude of approximately 20 mm.
[0194] Base 4 should have a distinct flaring in order to form the
shoulder piece which tapers out radially from the center of body 3.
When the PDA device is inserted into the blood vessel, this
shoulder piece then abuts the edge of the lumen to be treated at
high pressure. Forward section 2 is held in the blood vessel and
presses against the lower end of body 3 so that the shoulder piece
nestles against the vascular wall. This thus prevents the device
from dislodging from within the shunt.
[0195] The PDA occluder device as a form of application of the
present invention can be readily produced in accordance with the
above-described method by deforming a tubular metal fabric such
that it will conform to the surface of a mold; the fabric is then
subject to thermal treatment in order to fix its new form.
[0196] The PDA device pursuant FIG. 39 realizes a simplification in
that the use of synthetic material allows the sleeve in the
proximal area since the synthetic wires are welded flush together
at this location.
[0197] FIG. 40 is a drawing of a PDA device in the heart of a
patient for the purpose of PDA occlusion. The drawing shows the
device in a shunt extending from the "A" aorta to the "P" pulmonary
artery. The device is guided through the PDA in collapsed state by
a catheter. Subsequent thereto, the shoulder piece is allowed to
spring back into its "remembered shape" as occasioned by its prior
thermal treatment upon pushing the device out through the
catheter's distal end. The shoulder piece should be larger than the
shunt lumen of the PDA.
[0198] One then pulls somewhat on the device so that the shoulder
piece affixes to the wall of the "P" pulmonary artery. If pulling
continues on the catheter, the device will affix to the wall of the
PDA, thereby pulling its body section 3 out of the catheter. Body
section 3 can now expand. Body section 3 should be dimensioned such
that it engages in the lumen of the PDA shunt by means of friction.
The device is held in its place on the one hand by friction between
body section 3 and the lumen of the shunt and on the other hand by
the aorta's blood pressure against the shoulder piece of the
device. Thrombi develop in and on the device within a short time
and occlude the PDA. Occluding of the device as shown here can be
even further accelerated by coating same with a thrombolytic agent,
filling it with polyester fibers or a nylon material, or braiding a
larger amount of wire strands together.
[0199] FIGS. 41 to 44 show another variant of the PDA device. This
device has a cylindrical body 3, 4 which tapers to a point and a
shoulder piece 2 extending out radially from an end of the body.
The ends of the braided fabric are pressed inward in the cavity of
body section 3. Clamps are thereby disposed at each end of the
device's tubular fabric, by means of which the entire length of the
PDA device is shortened and its manipulation is simplified.
[0200] It is emphasized that the realization of the invention is
not limited to the embodiments associated with the figures, but
rather can be realized in a plurality of variants without departure
from the scope of the invention herein involved. It is intended
that all matter contained in the above description, as shown in the
accompanying drawings, the specification, and the claims shall be
interpreted in an illustrative, and not limiting sense.
* * * * *