Note: Descriptions are shown in the official language in which they were submitted.
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1
OCCLUSION DEVICE AND SURGICAL INSTRUMENT
AND METHOD FOR IMPLANTING OR EXPLANTING THE SAME
[0001] The present invention relates to an occlusion
device and a surgical instrument for the
implantation/explantation of an implant.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to an occlusion
device consisting of a braiding of thin wires given a
suitable form by means of a molding and heat treatment
procedure and which tapers to the diameter of a catheter
used for an intravascular implantation or explantation
procedure having a proximal retention area, a distal
retention area, at which the ends of the wires or threads
converge into a holder, and having a cylindrical crosspiece
interposed between said proximal retention area and said
distal retention area, whereby the two retention areas
position on the two sides of a shunt to be occluded in a
septum following implantation while the crosspiece
transverses the shunt. The invention moreover relates to a
surgical instrument for the implantation and explantation
of an implant, in particular an occlusion device as
described above. Lastly, the present invention relates to a
method for the repeated coupling of an implant, in
particular an occlusion device as described above, to such
a surgical instrument.
[0004] 2. Description of the Related Art
[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 to this end, each with their own
pros and cons, without any one specific occlusion system
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having yet become widely accepted. 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 positioned, for example, 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. 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.
[0006] 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
provided for this engagement to 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.
[0007] In previously-known occluders made of a
nitinol wire braiding, for example from AGA or JEN.meditec,
the coupling to the insertion wire is configured as a screw
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threading. The insertion wire provides for the occluder to
be urged forward or backward within the catheter tube.
After the occluder has been positioned in the septum of the
heart, the insertion wire is unscrewed and the occluder
ultimately released. No corrections are thereafter
possible.
[0008] Since the insertion wire and the coupling are
relatively rigid and the catheter approaches the septum of
the heart at a shallow angle in the minimally invasive
implantation of the occluder through the leg artery for
anatomical reasons, the occluder remains tilted upon its
unfolding and the umbrellas cannot abut both sides of the
shunt. In a situation such as this, the operating surgeon
cannot discern whether the occluder will assume its
predetermined fit once uncoupled. This gives rise to great
uncertainty for the surgeon, in particular since his only
means of repositioning an uncoupled occluder is a non-
minimally invasive procedure.
[0009] The present invention is based on minimizing
these crucial disadvantages of the known systems, namely by
allowing the occluder all freedom of movement for its
independent unfolding and adapting to the septal defect to
be occluded after its having been positioned in the septum
of the heart and released from the insertion port, and not
having it be forced into a position by the insertion
instrument which it would not automatically assume by
itself and yet having it be repositionable and retrievable
with a insertion instrument as necessary.
[0010] Of course, other embodiments are also
conceivable here as well. 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
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large size. A further disadvantage seen with other systems,
e.g. the so-called "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 fit. 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.
[0011] 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 septal 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.
[0012] An example of a self-centering occlusion
device of the type specified at the outset and in
accordance with the prior art is known from WO 99/12478 Al,
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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
5 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 such 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 as the umbrellas unfold. Because the collar
protrudes past the proximal retention area of the occluder,
the problem can arise that the inserted implant causes
embolic-related problems, in particular consecutive
embolization. Furthermore, a complete endothelialization of
occluder implant is often hindered.
[0013] An occlusion device made of wire braiding is
furthermore known from WO 95/27448 Al. This device,
however, does not have a holder such that this occluder
cannot be guided during introduction by an insertion
instrument in the same way as is the case with the devices
described above, nor can it be-in the case of a poor
seating-retracted again prior to being uncoupled.
[0014] The problem therefore set out for the present
invention is to refine such a braided self-centering
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occlusion device as known to medical technology such that
the disadvantages cited above will be overcome. A
particular objective is the providing of an occlusion
device applicable to occluding defects of different sizes,
whereby implantation of the occluder is to be a simple
matter and with which explantation is also possible; e.g.
to correct improper seating.
SUMMARY OF THE INVENTION
[0015] Based on the problem as posed, it is the task
of the present invention to provide an occlusion device
which, in the inserted state at the proximal end of the
septal defect, lies as flat as possible against the septum
and which can be retrieved following uncoupling should
improper positioning be indicated.
[0016] A further task of the present invention is
providing the corresponding surgical instrument as well as
a method for the repeatable coupling of an occlusion device
to such a surgical instrument.
[0017] These tasks are solved with the inventive
occlusion device of the type specified at the outset by the
provision of a holder having a head section at its free end
comprising an eyelet in the form of a cross-hole which can
be force-fit to and held by an implantation or explantation
instrument. Alternatively hereto, the task is inventively
solved with an occlusion device of the type specified at
the outset by the provision of a holder having a head
section at its free end configured as a semi-spherical
centering sleeve in longitudinal section comprising an
eyelet in the form of a cross-hole able to be held to an
implantation/explantation instrument by means of running a
fastening loop through it.
[0018] The procedural task set forth for the present
invention is alternatively solved by a method for the
repeatable coupling of an implant having a holder, in
particular an occlusion device, to a surgical instrument,
wherein a loop of insertion thread or guidewire is guided
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through the eyelet of the holder of the implant prior to
beginning the intravascular procedure and hooked on a fix
point provided for the purpose on gripper tongs while the
first and second loose ends of the insertion thread or
guidewire are held or fastened in the area of the first
gripping sections, where the head section of the holder of
the implant is grabbed by gripping tongs; the second loose
end of the inse'rtion thread/guidewire provided with a
nipple is tightened until the head section is fully
accommodated within the gripping jaws; then releasing the
second loose end provided with the nipple releases gripper
tongs from the head section of the implant and the seating
of the implant is checked; and where the insertion
thread/guidewire allows the gripper tongs to recouple with
the holder of the implant at any time.
[0019] In addition, the method for the repeatable
coupling of an implant having a holder, in particular an
occlusion device, to a surgical instrument, includes the
loop of insertion thread or guidewire being guided through
the diagonal slot in the eyelet of the holder of the
implant prior to beginning the intravascular procedure
while the first and second loose ends of the insertion
thread or guidewire are held or fastened in an area of said
first gripping section; where head section of the holder of
the implant is grabbed by gripping tongs; where the second
loose end of the insertion thread or guidewire provided
with a nipple is tightened until the head section is
accommodated within gripping jaws; where releasing the
second loose end provided with the nipple prompts the
releasing of gripping tongs from head section of the
implant and the seating of the implant is checked; where
insertion thread/guidewire allows gripper tongs to recouple
with the holder of the implant at any time.
[0020] Finally, a method for the repeatable coupling
of an implant having a holder, in particular an occlusion
device, to a surgical instrument includes a fastening loop
of defined length being fastened to eyelet of the holder of
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the implant; said fastening loop being then inserted into
the cross-groove of the cylindrical sleeve such that the
knot of the fastening loop fits centrically through the
protrusion and the section of fastening loop positioning in
cross-groove is held diametrically; where upon a defined
forward shifting of the hook, the section of the fastening
loop in the cross-groove slips over the hook in the second
longitudinal groove and remains anchored there; where
withdrawing of said hook pulls and clamps the holder of the
implant to the proximal face side of sleeve; where a
renewed defined forward displacing of hook will again
loosen fastening loop and the proximal front side of sleeve
loosens from holder and the seating of the implant can be
checked; where the use of the fastening loop allows
recoupling of sleeve to the holder of the implant at any
time.
[0021] Hence disclosed here as a solution to the task
facing the present invention is an entire system comprising
an implant in the form of an occlusion device, an
applicable surgical instrument thereto and a corresponding
method for the use of said surgical instrument.
[0022] Inventive advantages are in particular seen in
the provision of an intravascular occlusion device,
especially for the treatment of septum defects, which
affords a reliable hold during the implantation operation
with a correspondingly configured surgical instrument and
which can be released from the surgical instrument for the
purpose of verifying how the occlusion device is seated,
whereby particularly emphasized is the fact that it is
readily possible to subsequently take hold of the occlusion
device again, for example in order to change its
positioning or to effect immediate explantation.
[0023] Three alternative embodiments are herewith
proposed for configuring the holder of the occlusion device
in accordance with the invention.
[0024] Firstly, the head section of the holder can be
configured as a spherical head whereby the inside of the
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jaws of the surgical instrument's gripper tongs, which
correspond to the shape of the spherical head, are
configured so as to ensure a form-fit gripping of said
spherical head by the surgical instrument's gripper tongs.
So that a subsequent renewed gripping of the spherical head
will be readily possible after the connection between the
surgical instrument and the occlusion device has been
disengaged, the surgical instrument exhibits an insertion
thread or guidewire which protrudes in the form of a loop
from the proximal end of the surgical instrument's gripper
tongs in its delivery state, its two loose ends being held
or having been previously affixed near the grip for the
surgeon on the surgical instrument. Said insertion thread
or guidewire allows the gripper tongs of the surgical
instrument to easily and precisely reconnect to the head
section of the occlusion device's holder and thus re-grip
the occlusion device-for the purpose of repositioning or
explantation, for example.
[0025] In accordance with a second embodiment of the
occlusion device holder, the eyelet of the head section is
slit diagonally to the cross-hole whereby the ends of the
diagonal slot overlap with respect to the longitudinal
direction of the cross-hole. This thus enables the
insertion thread/guidewire, which protrudes from the
gripper tongs in the form of a loop at the proximal end of
the surgical instrument in delivery state, to hook into the
diagonal slot in the eyelet of the occlusion device holder
whereby the overlapping ends of the diagonal slot ensure
that the insertion thread/guidewire cannot readily, and in
particular not after said insertion thread/guidewire is
tensioned by the surgeon, inadvertently break free of the
eyelet and yet can nevertheless be intentionally moved out
of the eyelet through the diagonal bearing of the loop.
[0026] The dual-sided cut discharge surface of the
cross-hole is preferably configured to converge with the
outer surface of the spherical head toward the free end of
the holder. This has the advantage of there being no sharp
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edges which could damage the insertion thread or guidewire
and in addition facilitates threading the loop of the
insertion thread/guidewire through the eyelet of the holder
of the first embodiment. Last but not least, the converging
5 configuration to the cut discharge surface of the cross-
hole entails less material and weight.
[0027] In accordance with a third embodiment of the
occlusion device holder, the head section is formed as a
semi-spherical centering sleeve in longitudinal section and
10 likewise provided with an eyelet in the form of a cross-
hole. To connect with the corresponding surgical
instrument, a fastening loop, made of surgical suture for
example, is fed through the eyelet and, keeping to a
defined width of the fastening loop, its two ends are
knotted and hooked to the hooks of the corresponding
surgical instrument. While with the first and the second
embodiment of the holder's head section, the tensioning of
the insertion thread or guidewire ensues manually by the
surgeon pulling on one or both loose ends of said insertion
thread or guidewire, in the third embodiment, the
tensioning of the fastening loop ensues through the
retraction of the hook within the surgical instrument.
[0028] In the first and second embodiments, the push-
pull system of the surgical instrument preferably comprises
the following components: a coil spring, an actuator means
extending axially through its interior which is
sufficiently rigid in the axial direction yet still
flexible and having a shaft of the gripper tongs attached
to its proximal end as well as a first gripping section at
its distal end. The push-pull system moreover comprises a
taper sleeve for receiving the shaft of the axially-
displaceable gripper tongs at its proximal end section and
the proximal end of the coil spring is received by abutting
against a stop at its distal end section. A second gripping
section is also included here at which the distal end of
the coil spring is received by abutting against a stop
whereby the gripping jaws close from the force exerted by
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the coil spring on the outer adjacent proximal frontal end
of the taper sleeve and open as a result of the forward
advancing of the actuator means. The advantage of this
push-pull system essentially lies in its simplicity, and
the therein associated reliability of its components, and
in the secure gripping and releasing of the implant's
holder.
[0029] In the first embodiment of the holder, the
loop of the insertion thread or guidewire, protruding as
such from the gripping tongs in the delivery state of the
surgical instrument at its proximal end, and which is
guided through the interior of the taper sleeve and the
interior of the coil spring to the first gripping section
at the distal end of the surgical instrument by both loose
ends, is passed through the eyelet of the implant's holder
and affixed to the gripping tongs prior to implantation of
the implant. Tensioning the insertion thread or guidewire
leads to connecting the surgical instrument to the holder
of the occlusion device, which can occur repeatedly while
maintaining the connection.
[0030] Thus, the connection between the surgical
instrument and the occlusion device-to the insertion
thread/guidewire-can, for example, initially be disengaged
in order to verify the seating of the implant, and can
readily be restored using the insertion thread/guide-wire
should the seating of the implant be changed and the
surgical instrument thus needs to re-grip the implant's
holder. Also, should it become necessary for the implant to
be explanted again, a simple re-establishing of the
connection between the surgical instrument and the implant
is thereby enabled. In contrast, the loop in the second
embodiment is hung through the diagonal slot in the eyelet
and not, as is the case in the first embodiment, guided
through the eyelet.
[0031] In both the first as well as the second
embodiment of the holder; a first loose end of the
insertion thread or guidewire can be fastened in the area
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of a first gripping section while the second loose end of
the insertion thread or wire is provided with a nipple for
either aiding in the tensioning of the insertion
thread/guidewire in the coupled state of the implant or
extraction from the surgical instrument after the
connection of the first end is disengaged from the gripping
section. In the second embodiment of the holder, the loop
of the insertion thread or guidewire can thereby be moved
out of the eyelet through the diagonal slot after at least
one loose end of the insertion thread/guidewire has been
relaxed.
[0032] The insertion thread or guidewire is
preferably made from a nitinol wire, of which, for example,
also the braiding of the occlusion device itself can be
composed. Nitinol is a proven material in such surgical
procedures.
[0033] For the third embodiment of the holder of an
occlusion device, a surgical instrument is provided with a
hook which can move axially along the eyelet, toward and
away from same, by means of a push/pull system, whereby a
fastening loop which extends through the eyelet and which
can be hooked to the hook is used, by means of which the
implant can be held to the surgical instrument by
tensioning the fastening loop when the hook is moved away
from the eyelet. The advantage to this embodiment of the
surgical instrument is particularly noted to be that the
insertion thread or guidewire is replaced by the fastening
loop, thereby dispensing with the need to pull on the loose
ends of said insertion thread or guidewire in order to
tension the entire device as described with respect to the
other two embodiments; the tensioning instead ensues from
withdrawing the hook, which can follow from the appropriate
actuating of the surgical instrument.
[0034] In the third embodiment of the surgical
instrument, the push/pull system essentially comprises the
following components: a coil spring, an actuator means
extending axially through its interior which is
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sufficiently rigid in the axial direction yet still
flexible and having a shaft of the hook attached at its
proximal end and a first gripping section affixed to its
distal end; a cylindrical sleeve which receives the
proximal end of the coil spring by abutting against a stop
at its the distal end section and which accommodates the
shaft of the hook in axially-displaceable fashion; and a
second gripping section which receives the distal end of
the coil spring by abutting against a stop whereby the hook
is axially displaced away from the eyelet from the force
exerted by the coil spring and which is moved toward the
eyelet by the forward advancing of the actuator means. This
push-pull system likewise enables a very easy and reliable
manipulating of the occlusion device both before and during
the surgical procedure.
[0035] In order to even further simplify the
connection of the fastening loop extending through the
eyelet of the occlusion device holder to the push-pull
system, it is preferably provided for the cylindrical
sleeve to have a continuous first longitudinal groove on
the proximal forward side, a second longitudinal groove at
one side of its center section for the anti-twist guiding
of the axially-displaceable hook in the sleeve, and a
cross-groove disposed at a right angle to the second
longitudinal groove on the one side which extends to the
longitudinal axis of the sleeve and has a protrusion at its
center for receiving a knot of the fastening loop. The
protrusion to receive the knot of the fastening loop also
ensures, among other things, that the fastening loop is
seated firmly within the cross-groove.
[0036] In order to ensure the hook can securely grip
the fastening loop, it is preferably provided for the
cross-section of the forward section of the hook to be
configured roughly one-third flatter than the cross-section
of the shaft and to exhibit play when fitted into the
second longitudinal groove of the cylindrical sleeve.
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[0037] To sever the connection between the surgical
instrument and the implant holder, a blade is provided at
the distal end of the gap configured behind the hook.
[0038] While it is preferable for the material of the
surgical instrument's actuator means to be a wire,
absolutely any other material which is rigid enough in the
axial direction yet still sufficiently flexible can also be
used.
[0039] 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.
[0040] 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.
[0041] 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
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not depart from the spirit and scope of the methods and
apparatuses consistent with the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
5 [0042] The following will make reference to the
drawings in providing a more precise detailing of the three
preferred embodiments of the occlusion device and the three
embodiments of a surgical instrument related thereto as
well as the three different methods for a repeatable
10 coupling of an implant, occlusion device respectively, to
the associated surgical instrument. In conjunction hereto,
embodiment 1 is represented in FIGS. 1 to 7, embodiment 2
in FIGS. 8 to 14, and embodiment 3 in FIGS. 15 to 24.
[0043] FIG. 1 shows a side view of a first embodiment
15 of an occlusion device with a surgical instrument
associated therewith in accordance with embodiment 1;
[0044] FIG. 2 shows an enlarged sectional
representation of the partial "A" section pursuant to FIG.
1;
[0045] FIG. 3 shows a perspective representation of
an occlusion device embodiment;
[0046] FIG. 4 shows an enlarged side view of a first
embodiment of a holder for the occlusion device;
[0047] FIG. 5 shows a perspective representation of
the holder pursuant to FIG. 4;
[0048] FIG. 6 shows an enlarged detail view of the
gripper tongs of an occlusion device including guidewire
and holder;
[0049] FIG. 7 shows a view of the forward section of
the surgical instrument and an occlusion device having a
loop pulled through same;
[0050] FIG. 8 shows a side view of a surgical
instrument with an occlusion device at the insertion
thread/guidewire in accordance with a second embodiment;
[0051] FIG. 9 shows a sectional detail view of the
forward section of the surgical instrument with the
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a =
16
occlusion device at the insertion filament/wire pursuant to
FIG. 8;
[0052] FIG. 10 shows an enlarged side view of a
holder of an occlusion device in accordance with embodiment
2;
[0053] FIG. 11 shows a perspective representation of
the holder pursuant to FIG. 10;
[0054] FIG. 12 shows a simplified view of the forward
section of the surgical instrument with gripper tongs,
insertion thread/guidewire and occlusion device;
[0055] FIG. 13shows an enlarged detail view of the
"A" section pursuant to FIG. 12;
[0056] FIG. 14 shows a view of the forward section of
the surgical instrument with gripper tongs and occlusion
device with hooked guidewire loop;
[0057] FIG. 15 shows a compressed sectional
representation of a surgical instrument with hooked
occlusion device in accordance with embodiment 3;
[0058] FIG. 16 shows a sectional detail view pursuant
"B" from FIG. 15;
[0059] FIG. 17 shows a section through the forward
section of the surgical instrument with coupled occlusion
device;
[0060] FIG. 18 shows an enlarged side view of the
holder of an occlusion device in accordance with embodiment
3;
[0061] FIG. 19 shows a perspective representation of
the holder pursuant to FIG. 18;
[0062] FIG. 20 shows an enlarged perspective
representation of the cylindrical sleeve in accordance with
embodiment 3;
[0063] FIG. 21 shows an enlarged perspective
representation of the hook pursuant to FIG. 17;
[0064] FIG. 22 shows a perspective representation of
the forward section of the surgical instrument with the
coupled holder of an occlusion device in accordance with
the third embodiment;
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17
[0065] FIG. 23 shows a perspective representation
similar to that of FIG. 22; and
[0066] FIG. 24 shows an enlarged perspective
representation of the forward section of the surgical
instrument with an occlusion device in accordance with the
third embodiment for depicting the coupling via a fastening
loop.
DESCRIPTION OF THE INVENTION
[0067] FIGS. 1 and 2 show a side and detail view of a
first embodiment of a surgical instrument 100 for the
implantation and explantation of an implant serving here as
an example of an implant coupled to an occlusion device 1.
Surgical instrument 100 exhibits gripper tongs 102, the
gripping jaws 103, 104, 105 of which can be opened and
closed by means of a push/pull system. The inside areas of
gripping jaws 103, 104, 105 are configured such that they
can grab the spherically-configured head section 14 of
holder 10 of the implant in a force-fit lock. The push/pull
system essentially comprises the following components: a
coil spring 106, through the interior of which an actuator
means 107 extends which is rigid in the axial direction yet
still sufficiently flexible, a shaft 111 of gripper tongs
102 being affixed at its proximal end and a first gripping
section 108 disposed at its distal end. The push-pull
system additionally comprises a taper sleeve 109 which
receives the shaft 111 of the axially-displaceable gripper
tongs 102 at its proximal end section 112 and the proximal
end of the coil spring 106 at its distal end section 113 by
abutting against a stop 114. The push-pull system
additionally and essentially comprises a second gripping
section 110, at which the distal end of the coil spring 106
is received by abutting against a stop, whereby gripping
jaws 103, 104, 105 close from the force exerted by the coil
spring 106 on the outer adjacent proximal frontal end 115
of the taper sleeve 109 and open as a result of the forward
advancing of the actuator'means 107. As a particularly
CA 02627412 2008-04-25
18
essential component, said surgical instrument 100 has an
insertion thread or guidewire 116 which extends out of
gripper tongs 102 in the delivery state of surgical
instrument 100 from its proximal end in the form of a loop
117 and which is guided by the two loose ends 118, 119
through the interior of taper sleeve 109 and the interior
of coil spring 106 to a first gripping section 108 at the
distal end of surgical instrument 100, whereby loop 117 can
be introduced through eyelet 16 of holder 10 prior to the
implantation of the implant and affixed to gripper tongs
102 at a fix point 101. Insertion thread or guidewire 116
exhibits a first loose end 119 attachable in the area of
the first gripping section 108 and a second loose end 118
which is provided with a nipple 120, with the help of which
the insertion thread/guidewire 116 can either be stretched
out in the coupled state of the implant or be retracted
from the surgical instrument 100 after the connection
between the first end 119 and the first gripping section
108 has been disengaged. Said retracting of the insertion
thread/guidewire from surgical instrument 100 does not
occur until the implanted occlusion device exhibits the
exact seating as desired by the surgeon. Should this not be
the case, the insertion thread/guidewire 116 serves in
readily allowing the surgeon to re-connect gripping tongs
102 of surgical instrument 100 to the head section 14 of
holder 10 of occlusion device 1; i.e., gripping jaws 103,
104, 105 of gripper tongs 102 can grab spherical-shaped
head section 14 of holder 10 securely and in form-fit
fashion.
[0068] FIG. 3 shows an example of an occlusion device
which can be provided with an inventive holder 10. This
occlusion device essentially consists of a braiding 2 of
thin wires or threads 4 which is given a suitable final
form by means of a molding and heat treatment procedure and
which tapers to the diameter of a catheter 5 used for an
intravascular implanting or explanting surgical procedure.
Said occlusion device comprises a proximal retention area 6
CA 02627412 2008-04-25
19
and a distal retention area 8 at which the ends of the
wires or threads 4 converge into a holder 10, as well as a
cylindrical crosspiece 12 between said proximal retention
area 6 and said distal retention area 8, whereby the two
retention areas 6, 8 position on the two sides of a shunt
to be occluded in a septum following implantation while the
crosspiece 1 transverses the shunt. The occlusion device is
thus particularly suited to treating septum defects with
the device able to be introduced to the defect to be
occluded via a catheter 5. Because the proximal retention
area 6 of braiding 2 exhibits a single-layered, plate-
shaped flattening toward the proximal end of the occlusion
device, this allows 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. In other words, this
means that the occlusion device is ingrown by the body's
own tissue substantially faster than is the case with the
occluding systems known in the prior art.
[0069] Using a braiding composed of thin wires or
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. The braiding moreover
has sufficient rigidity. The plate-shaped hub-less profile
to braiding 2 toward the proximal end additionally allows
the proximal retention area 6 of the occlusion device to
flatten completely against the lateral edge of the defect
in the inserted state. As a result, the occlusion device
can be used for a wide range of differently sized septal
defects. Since braiding 2 tapers to the diameter of a
catheter used in intra-vascular surgery, it is possible to
CA 02627412 2008-04-25
introduce the occlusion device through e.g. a vein, such
that it is no longer necessary to perform an open operation
in the literal sense. Because braiding 2 is made from a
material which has "memory" effect, the occlusion device
5 can also be termed a "self-expanding device" which, upon
exiting the catheter, unfolds by itself such that the two
retention areas 6, 8 can position accordingly on the
proximal/distal sides of the defect.
[0070] FIG. 4 shows an enlarged side view of a first
10 embodiment of a holder 10 of such an occlusion device. This
holder 10 exhibits a head section 14 at its free end having
an eyelet 16 in the form of a cross-hole, whereby head
section 14 can be gripped and held by surgical instrument
100 in form-fit fashion.
15 [0071] FIG. 5 shows a perspective representation of
the holder according to FIG. 4. This representation helps
to illustrate how the dual-sided cut discharge surface 18,
20 of the cross-hole is configured to converge with the
outer surface of the spherical head toward the free end of
20 holder 10.
[0072] FIG. 6 shows an enlarged detail view of
surgical instrument 100 with guidewire 116 extending
through eyelet 16 which is hooked in the form of a loop 117
at shaft 111 of gripper tongs 102 (cf. FIG. 2, fix point
101). This representation helps to illustrate how gripper
tongs 102 are provided with an outer tapering at the front
and divided into three gripping jaws 103, 104, 105 by means
of longitudinal grooves which close upon positioning of the
tapered shaft at the proximal forward end 115 of taper
sleeve 109. Gripping jaws 103, 104, 105 are hereby rotated
to reflect the shape of a bowl in order to force-fit grip
the spherical head section 14 of holder 10. Shaft 111 of
gripper tongs 102 is of flattened configuration in order to
guide loop 117 of insertion thread/guidewire 116 through
taper sleeve 109. Loop 117 is prepared such that it will
protrude from gripper tongs 102 in the delivery state (see
FIG. 7). The loose ends 118, 119 of insertion
CA 02627412 2008-04-25
21
thread/guidewire 116 are guided through the slot in gripper
tongs 102 and through coil spring 106 and fastened at the
first gripping section 108 of the grip, whereby the first
loose end 118 is additionally provided with a nipple 120
which facilitates the gripping and tensioning of the
insertion thread/guidewire.
[0073] FIG. 7 depicts a simplified view of the
forward section of surgical instrument 100 comprising the
taper sleeve 109, gripper tongs 102, coil spring 106 and
actuator means 107. Loop 117 of insertion thread/guidewire
116 can be seen in front of gripper tongs 102 and already
fed through eyelet 16 of head section 14 of holder 10. The
section emphasized by the "A" circle represents the
enlarged detail view in accordance with FIG. 6.
[0074] To couple occlusion device 1, loop 117 of
insertion thread/guidewire 116 is pulled through eyelet 16
and hooked to a fix point 101 provided for the purpose on
shaft 111 of gripper tongs 102 (see FIG. 2). The thread or
wire material comprising loop 117 of insertion
thread/guidewire 116 thereby extends through each
respective slot between gripping jaws 103, 104 and 105
while the returning ends run through the third slot between
gripping jaws 104, 105. When gripper tongs 102 are
retracted in taper sleeve 109 by tightening insertion
thread/guidewire 116, loop 117 can no longer hang on. Loop
117 is then pulled so far toward nipple 120 until the
spherical head section 14 of holder 10 sinks into the
gripping jaws 103, 104, 105 of gripper tongs 102. The other
end 119 of insertion thread/guidewire 116 not disposed with
the nipple 120 is fastened appropriately in the area of
second gripping section 108.
[0075] A method for the repeatable coupling of an
implant with a holder 10 as described above, in particular
of an occlusion device 1, to surgical instrument 100 will
be described in the following.
[0076] In a first step, loop 117 of insertion
thread/guidewire 116 is guided through eyelet 16 of holder
CA 02627412 2008-04-25
22
of the implant prior to beginning the intravascular
procedure and hooked on a fix point 101 provided for the
purpose on gripper tongs 102 while the first and second
loose ends 119, 118 of insertion thread/guidewire 116 are
5 held or fastened in the area of first gripping section 108.
In a second step, head section 14 of holder 10 of the
implant is grabbed by gripping tongs 102. In a third step,
the second loose end 118 of insertion thread/guidewire 116
provided with nipple 120 is tightened until head section 14
10 is fully accommodated within gripping jaws 103, 104, 105.
Releasing the second loose end 118 provided with the nipple
prompts the releasing of gripping tongs 102 from head
section 14 of the implant and the seating of the implant is
checked. Insertion thread/guidewire 116 allows gripper
tongs 102 to recouple to holder 10 of the implant at any
time.
[0077] FIGS. 8 and 9 show a condensed side view and a
detail view of a second embodiment of a surgical instrument
200 with an occlusion device 1 to be coupled thereto,
exhibiting a holder 10 of a second embodiment of the
present invention. The reference numerals from FIGS. 1 and
2 are again repeated here to identify the same components
to surgical instrument 200 and occlusion device 100. The
difference between this second embodiment of occlusion
device 1, the second embodiment of surgical instrument 200
respectively, and the same components of the first
embodiment lies in the configuration of the head section 14
of holder 10 of occlusion device 1 and in how the insertion
thread/guidewire 116 is used and guided, which becomes
clear when viewing FIG. 9: in same, loop 117 of insertion
thread/guidewire 116 is not guided through eyelet 16 of
head section 14 with the two threads or wires but rather
only one thread runs through said eyelet 16 and is
otherwise led by its two loose ends 118, 119 through the
interior of taper sleeve 109 and the interior of coil
spring 106 to first gripping section 108 at the distal end
of surgical instrument 200. the connecting of insertion
CA 02627412 2008-04-25
23
thread/guidewire 116 to head section 14 of holder 10 will
be described in the following by making reference to FIGS.
and 11.
[0078] FIGS. 10 and 11 show an enlarged side view
5 (FIG. 10) and a perspective representation respectively
(FIG. 11) of a second embodiment of a holder 10 of an
occlusion device 1. This second embodiment differs from the
first embodiment pursuant FIGS. 4 and 5 in that eyelet 16
of head section 14 is slit diagonal to the cross-hole,
10 whereby the ends 22, 24 of diagonal slot 26 overlap with
respect to the longitudinal direction of the cross-hole.
Other than that, this second embodiment of head section 14
likewise exhibits a spherical head and the dual-sided cut
discharge surface 18, 20 of the cross-hole is preferably
configured to converge with the outer surface of the
spherical head toward the free end of holder 10. Since
eyelet 16 has a diagonal slot 26, loop 117 of insertion
thread/guide-wire 116 can be moved into eyelet 16 without
needing to loop a loose end 118, 119 of the insertion
thread through eyelet 16 or even pass the entire loop 117
through eyelet 16 to hook onto shaft 111 of gripping tongs
102. Diagonal slot 26 thus enables an especially easy
hooking of loop 117.
[0079] Eyelet 16 yields the advantage that loop 117
can be removed at any time in the same way, namely by the
surgeon upon determining that occlusion device 1 is
properly seated and surgical instrument 200 is to be
ultimately disengaged from occlusion device 1. To do so,
loop 117 is withdrawn from eyelet 16 and from the entire
surgical instrument 200 as in the first embodiment by
pulling on one of the loose ends 118, 119, preferably,
however, the second loose end 118 provided with,nipple 120.
[0080] FIG. 12 shows a simplified representation of
the forward section of surgical instrument 200 with loop
117 protruding from the tip of gripper tongs 102 and the
occlusion device 1 to be coupled, all in accordance with
the second embodiment.
CA 02627412 2008-04-25
24
[0081] FIG. 13 shows an enlarged detail view of
gripper tongs 102 with loop 117 of insertion
thread/guidewire 116 protruding from between gripping jaws
103, 104, 105 (gripping jaws 104, 105 are not visible in
this representation).
[0082] FIG. 14 shows a representation similar to that
of FIG. 12, wherein FIG. 14 shows surgical instrument 200
already having been connected to occlusion 1.
[0083] The push/pull system of the second embodiment
of surgical instrument 200 consists of the same components
as was described above with respect to the first
embodiment.
[0084] The method for the repeatable coupling of an
implant having a holder 10 of the second embodiment, an
occlusion device 1 in particular, to a surgical instrument
100 in accordance with the second embodiment will be
described in the following: in a first step, loop 117 of
insertion thread/guidewire 116 is guided through diagonal
slot 26 in eyelet 16 of holder 10 of the implant prior to
beginning the intravascular procedure while the first and
second loose ends 119, 118 of insertion thread/guidewire
116 are held or fastened in the area of first gripping
section 108. In a next step, head section 14 of holder 10
is grabbed by gripper tongs 102. The second loose end 118
of insertion thread/guidewire 116 provided with nipple 120
is then tensioned until the head section 14 is fully
accommodated within gripping jaws 103, 104, 105. Loosening
the second loose end 118 provided with nipple 120 allows
the releasing of gripper tongs 102 from head section 14 of
the implant and the seating of the implant can be checked.
Insertion thread/guidewire 116 allows gripper tongs 102 to
recouple to holder 10 of the implant at any time. If
occlusion device 1 is to be ultimately disengaged from
surgical instrument 200, insertion thread/guidewire 116 is
withdrawn from the surgical instrument by pulling on the
second loose end 118 provided with nipple 120. During the
extracting, it is important for loop 117 to be flexible
CA 02627412 2008-04-25
~ =
enough to wind around the tight radii and for there to be
no sharp edges to the deflection points on the eyelet 16 or
gripper tongs 102. With respect to eyelet 16, same is
secured as described above in that the dual-sided cut
5 discharge surface 18, 20 of the cross-hole is configured to
converge with the outer surface of the spherical head
toward the free end of holder 10. Moreover, using thin,
super-elastic nitinol wire as the insertion
thread/guidewire 116 is particularly suitable, even though
10 surgical suture may also be used.
[0085] FIGS. 15, 16 and 17 show a compressed
sectional representation (FIG. 15), a perspective detail
representation pursuant the "B" circle of FIG. 15, and a
sectional representation through the forward region of a
15 surgical instrument 300 with an occlusion device 1, all of
the third embodiment. Surgical instrument 300 essentially
exhibits a hook 302 which is axially movable toward and
away from eyelet 16 of head section 14 of holder 10 of
occlusion device 1 by means of a push-pull system as well
20 as a fastening loop 301 extending through eyelet 16 and
fixable at hook 302, by means of which the implant can be
held to surgical instrument 300 through the tensioning of
fastening loop 301 when hook 302 is moved away from eyelet
16. In this case, the push/pull system consists essentially
25 of the following components: a spiral coil 106, an actuator
means 107 extending axially through the interior of the
latter which is sufficiently rigid in the axial direction
yet still sufficiently flexible, with a shaft of hook 302
attached to its proximal end as well as a first gripping
section 108 at its distal end. The push-pull system
moreover essentially exhibits a cylindrical sleeve 304 for
receiving the proximal end of coil spring 106 at its distal
end section 113 by abutting against a stop 114 and in which
shaft 303 of hook 302 is accommodated in axially-
displaceable fashion. Lastly, this push/pull system of this
said third embodiment includes another second gripping
section 110 at which the distal end of the coil spring 106
CA 02627412 2008-04-25
26
is received by abutting against a stop, whereby hook 302 is
moved away axially from eyelet 16 by the force exerted by
coil spring 106 which can be moved toward eyelet 16 by the
forward advancing of actuator means 107.
[0086] FIGS. 18 and 19 respectively show an enlarged
side view and an enlarged perspective representation of the
third embodiment of a holder 10 of occlusion device 1. This
third embodiment differs from the other two embodiments in
that holder 10 exhibits a head section 14 at its free end
configured as a centering sleeve having an eyelet 16 in the
form of a semi-spherical cross-hole in longitudinal section
and holder 10 can be held to surgical instrument 300 by
means of a fastening loop 301 extending through eyelet 16
(cf. FIGS. 16 and 17).
[0087] FIG. 20 shows a perspective representation of
cylindrical sleeve 304 of surgical instrument 300 in
accordance with the third embodiment. Cylindrical sleeve
304 exhibits a continuous first longitudinal groove 306 at
the proximal forward side 304, a second longitudinal groove
307 at one side of its center section for anti-twist
guidance of the axially-displaceable hook 302 in the
sleeve, and a cross-groove 308 at a right angle to the
second longitudinal groove 307 on the one side which
extends to the longitudinal axis of sleeve 304 and has a
protrusion 309 at its center for receiving a knot 311 of
fastening loop 301. The second longitudinal groove 307 is
thus configured such that it cuts through the circumference
of sleeve 304 from outer to inner diameter.
[0088] FIG. 21 shows a perspective representation of
hook 302 with its shaft 303. The cross-section of the
forward section of hook 302 is configured to be about one-
third flatter than the cross-section of shaft 303,
indicated by reference numeral 314. The flattened forward
section of hook 302 thus fits with play into the second
longitudinal groove 307 of cylindrical sleeve 304 (FIG.
20). A gap 315 of no material is configured behind the tip
of hook 302, exhibiting a blade 310 at its distal end.
CA 02627412 2008-04-25
27
[0089] FIG. 22 shows a perspective representation of
the forward section of surgical instrument 300, which is
unfixedly coupled to holder 10 of occlusion device 1 by
means of fastening loop 301. Fastening loop 301 thus
inserts into cross-groove 308 such that knot 311 of
fastening loop 301 positions at protrusion 309 of cross-
groove 308 while the thread of fastening loop 301
diametrically transverses cylindrical sleeve 304 in cross-
groove 308. Cross-groove 308 is hereby configured such that
knot 311 cannot break free laterally from the hooked
fastening loop 301.
[0090] FIG. 23 shows a representation similar to FIG.
22, whereby the hook 302 inserted in cylindrical sleeve 304
is depicted with dashed lines. Upon a defined forward
shifting of hook 302, fastening loop 301 basically slips
over the tip of the hook from longitudinal groove 307 and
remains in the gap 315 configured behind same. The knot of
fastening loop 301 is situated in one of the side chambers
formed by the flat section 314 of hook 302. Withdrawing
hook 302 pulls occlusion device 1 with its holder 10 and
the frontal side 305 of the cylindrical sleeve tight to
surgical instrument 300. Fastening loop 301 thereby runs
out from the continuous first longitudinal groove 306 at
both sides and along the circumference of sleeve 304 until
it is again guided along the cross-groove 308 inwardly and
rearward of hook 302. Occlusion device 1 is thus coupled
without play to the pull/pull system of surgical instrument
300 and can be inserted into a catheter 5 (not shown here).
[0091] For the final uncoupling of occlusion device 1
from surgical instrument 300, the stops 312, 313 disposed
in the second gripping section 110 are released, whereby
hook 302 can be pushed further forward a defined distance.
The blade 310 arranged at the distal end of gap 315 behind
the tip of the hook 302 is then activated. By withdrawing
the surgical instrument, fastening loop 301 within cross-
groove 308 is namely tensioned diametrically and can thus
be separated by blade 310 by the forward displacement of
CA 02627412 2008-04-25
28
hook 302. In consequence thereof, the end without a knot of
fastening loop 301 separates from eyelet 16 of holder 10
upon withdrawal of surgical instrument 300, whereby the
other end of fastening loop 301 with knot 311 ultimately
remains within cross-groove 308 and thus on hook 302.
[0092] FIG. 24 shows a representation similar to that
of FIG. 23 whereby occlusion device 1 is also shown on
holder 10, attached by means of holder 10 and by means of
fastening loop 301 in cross-groove 308 of sleeve 304.
[0093] The following will more precisely describe the
third embodiment method for the repeated coupling of an
implant having a holder 10, in particular an occlusion
device 1, to a surgical instrument 300:
[0094] In a first procedural step, a fastening loop
301 of defined length is fastened to eyelet 16 of the
implant's holder 10. Fastening loop 301 is then inserted
into cross-groove 308 of cylindrical sleeve 304 such that
knot 311 of fastening loop 301 fits centrically through
protrusion 309 and the section of fastening loop 301
positioning in cross-groove 308 is held diametrically. Upon
a defined forward shifting of hook 302, the section of
fastening loop 301 in cross-groove 308 namely slips over
hook 302 in the second longitudinal groove 307 and remains
anchored there. By withdrawing hook 302, holder 10 of the
implant is pulled and clamped to the face side 305 of
sleeve 304. A renewed defined forward displacing of hook
302 will again loosen fastening loop 301 and the proximal
front side 305 of sleeve 304 will loosen from holder 10 and
the seating of the implant can be checked. The use of
fastening loop 301 allows recoupling of sleeve 304 to
holder 10 of the implant at any time. An unintentional
releasing of occlusion device 1 from surgical instrument
300 is prevented by the following measures: firstly,
fastening loop 301 cannot slip off hook 302 by itself in
the tensioned state. Secondly, neither can fastening loop
301 slip from hook 302 in the relaxed state since the hook
opening is closed by the sleeve 304 which surrounds it.
CA 02627412 2008-04-25
29
Thirdly, hook 302 is secured against twisting within the
second longitudinal groove 307 of sleeve 304 so that
neither can the hook opening position in front of cross-
groove 308. Fourthly, blade 310 remains in secured state
behind cross-groove 308 in second gripping section 110 due
to stops 312, 313 and can thus neither contact nor sever
the unrelaxed or tensioned fastening loop 301. Finally,
blade 310 can only be led into gap 315 of hook 302 by
conscious and deliberate interaction with the actuator
member of the surgical instrument 300 and by its slight
withdrawing from the tensioned fastening loop 301 in order
to cut same. Only the slight retraction of surgical
instrument 300 will diametrically tension fastening loop
301 through cross-groove 308 and only a defined forward
displacement of hook 302 with its blade 310 can cut through
fastening loop 301.
[0095] Since certain changes may be made in the above
device 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.
