U.S. patent application number 11/878744 was filed with the patent office on 2008-01-17 for occlusion device and surgical instrument and method for its implantion/explantation.
This patent application is currently assigned to OCCLUTECH GMBH. Invention is credited to Hans Reiner Figulla, Friedrich Moszner, Robert Moszner, Rudiger Ottma.
Application Number | 20080015619 11/878744 |
Document ID | / |
Family ID | 38041905 |
Filed Date | 2008-01-17 |
United States Patent
Application |
20080015619 |
Kind Code |
A1 |
Figulla; Hans Reiner ; et
al. |
January 17, 2008 |
Occlusion device and surgical instrument and method for its
implantion/explantation
Abstract
An occlusion device includes a braiding of thin wires or threads
tapering to the diameter of a catheter used for an intravascular
implantation/explantation procedure and having a proximal retention
area, a distal retention area at which ends of the wires or threads
converge into a holder, and a cylindrical crosspiece interposed
between the proximal retention area and the distal retention area,
whereby the two retention areas are positioned on two sides of a
shunt to be occluded in a septum following implantation while the
crosspiece transverses the shunt. The holder exhibits a head
section at its free end having an eyelet as a cross-hole which can
be gripped and held in form-fit fashion by an
implantation/explantation instrument. A surgical instrument having
such a holder includes gripper tongs with gripping jaws which open
and close by a push/pull system, and which force-fit grips the head
section of the holder.
Inventors: |
Figulla; Hans Reiner; (Jena,
DE) ; Moszner; Friedrich; (Hohlstedt, DE) ;
Moszner; Robert; (Bad Klosterlausnitz, DE) ; Ottma;
Rudiger; (Grossschwabhausen, DE) |
Correspondence
Address: |
AKERMAN SENTERFITT
801 PENNSYLVANIA AVENUE N.W.
SUITE 600
WASHINGTON
DC
20004
US
|
Assignee: |
OCCLUTECH GMBH
Jena
DE
|
Family ID: |
38041905 |
Appl. No.: |
11/878744 |
Filed: |
July 26, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11271752 |
Nov 14, 2005 |
|
|
|
11878744 |
Jul 26, 2007 |
|
|
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Current U.S.
Class: |
606/157 ;
606/215 |
Current CPC
Class: |
A61B 2017/00592
20130101; A61B 2017/00575 20130101; A61B 17/0057 20130101; A61B
2017/00606 20130101; A61B 2017/00623 20130101; A61B 2017/00619
20130101 |
Class at
Publication: |
606/157 ;
606/215 |
International
Class: |
A61B 17/08 20060101
A61B017/08 |
Claims
1. A method for the repeatable coupling of an implant, in
particular, an occlusion device to a surgical instrument, said
implant having a holder which exhibits a head section at its free
end disposed with an eyelet in the form of a cross-hole which can
be force-fit to and held by an implantation or explantation
instrument, said surgical instrument being provided with gripper
tongs, the gripping jaws of which can be opened and closed by means
of a push/pull system and which are configured so as to be able to
grip head section of holder of the implant in a force-fit lock
comprising by the following process steps: a. loop of insertion
thread or guidewire is guided through 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 first gripping sections, b.
head section of holder of the implant is grabbed by gripping tongs;
c. the second loose end of insertion thread/guidewire provided with
nipple is tightened until head section is fully accommodated within
gripping jaws; d. releasing the second loose end provided with the
nipple releases gripper tongs from head section of the implant and
the seating of the implant is checked; e. insertion
thread/guidewire allows gripper tongs to recouple with holder of
the implant at any time.
2. The method of claim 1, wherein the implant is an occlusion
device consisting of a braiding of thin wires or threads 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
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.
3. The method of claim 1, wherein the head section of the implant
is configured as a spherical head.
4. The method of claim 1, wherein the dual-sided cut discharge
surface of the cross-hole is configured to converge with the outer
surface of the spherical head toward the free end of the
holder.
5. The method of claim 1, wherein the push/pull system of the
surgical instrument essentially comprises the following components:
a coil spring, through the interior of which an actuator means 107
extends axially being rigid in the axial direction yet still
sufficiently flexible, a shaft of gripper tongs being affixed at
its proximal end and a first gripping section at its distal end; a
taper sleeve which receives the shaft of the axially-displaceable
gripper tongs at its proximal end section and the proximal end of
coil spring at its distal end section by abutting against a stop;
and a second gripping section, at which the distal end of coil
spring is received by abutting against a stop, whereby gripping
jaws close from the force exerted by the coil spring on the outer
adjacent proximal frontal end of taper sleeve and open as a result
of the forward advancing of actuator means.
6. The method of claim 1, wherein the surgical instrument is
provided with an insertion thread or guidewire which extends out of
gripper tongs in the delivery state of said surgical instrument
from its proximal end in the form of a loop and which is guided by
the two loose ends through the interior of taper sleeve and the
interior of coil spring to said first gripping section at the
distal end of the surgical instrument, whereby loop can be guided
through eyelet of holder of the implant and affixed to gripper
tongs prior to the implantation of the implant.
7. A method for the repeatable coupling of an implant, in
particular, an occlusion device, to a surgical instrument, said
implant having a holder, which exhibits a head section at its free
end disposed with an eyelet in the form of a cross-hole which can
be force-fit to and held by an implantation or explantation
instrument, said eyelet being slit diagonally to the cross-hole,
whereby the ends of the diagonal slot overlap with respect to the
longitudinal direction of the cross-hole, said surgical instrument
being provided with gripper tongs, the gripping jaws of which can
be opened and closed by means of a push/pull system and which are
configured so as to be able to grip head section of holder of the
implant in a force-fit lock, wherein the push/pull system
essentially comprises the following components: a coil spring,
through the interior of which an actuator means extends axially
being rigid in the axial direction yet still sufficiently flexible,
a shaft of gripper tongs being affixed at its proximal end and a
first gripping section at its distal end; a taper sleeve which
receives the shaft of the axially-displaceable gripper tongs at its
proximal end section and the proximal end of coil spring at its
distal end section by abutting against a stop; and a second
gripping section, at which the distal end of coil spring is
received by abutting against a stop, whereby gripping jaws close
from the force exerted by the coil spring on the outer adjacent
proximal frontal end of taper sleeve and open as a result of the
forward advancing of actuator means, and wherein a first loose end
of said insertion thread or guidewire is attachable in the area of
the first gripping section while the second loose end of said
insertion thread or guidewire is provided with a nipple, with the
help of which the insertion thread or guidewire can either be
stretched in the coupled state of the implant after loop having
moved through the diagonal slot in eyelet or has again become so
loose upon the uncoupling of the implant from the operative device
that said loop can be moved out of the eyelet through diagonal
slot, comprising by the following process steps: (a) loop of
insertion thread or guidewire is guided through the diagonal slot
in eyelet of holder of the implant prior to beginning the
(intravascular procedure while the first and second loose ends of
insertion thread or guidewire) are held or fastened in an area of
said first gripping section; (b) head section of holder of the
implant is grabbed by gripping tongs; (c) the second loose end of
insertion thread or guidewire provided with nipple is tightened
until head section is accommodated within gripping jaws; (d)
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; (e) insertion
thread/guidewire allows gripper tongs to recouple with holder of
the implant at any time.
8. A method for the repeatable coupling of an implant, in
particular, an occlusion device having a holder, to a surgical
instrument, said implant consisting of a braiding of thin wires or
threads 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 used for an intravascular implantation or explantation
procedure, having a proximal retention area a distal retention
area, at which the ends of wires or threads converge into a holder,
and having a cylindrical crosspiece 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, whereby said holder exhibits 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 and able
to be held to an implantation/explantation instrument by means of
running a fastening loop through said eyelet, said surgical
instrument having a hook is provided which is axially movable
toward and away from eyelet by means of a push/pull system as well
as a fastening loop extending through said eyelet and hookable to
hook, 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, comprising by the following process steps:
(a) a fastening loop of defined length is fastened to eyelet of
holder of the implant; (b) said fastening loop is then inserted
into cross-groove of cylindrical sleeve such that knot of fastening
loop fits centrically through protrusion and the section of
fastening loop positioning in cross-groove is held diametrically;
(c) upon a defined forward shifting of hook, the section of
fastening loop in the cross-groove slips over hook in the second
longitudinal groove and remains anchored there; (d) withdrawing of
said hook pulls and clamps holder of the implant to the proximal
face side of sleeve; (e) 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; (f) the use of fastening loop allows recoupling of sleeve
to holder of the implant at any time.
9. The method of claim 8, wherein the push/pull system of said
surgical instrument essentially 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, having a shaft of hook attached at its proximal end
and a first gripping section affixed at its distal end; a
cylindrical sleeve which receives the proximal end of the coil
spring by abutting against a stop at its distal end section and
which accommodates the shaft of 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 eyelet from the force exerted by the
coil spring and which is moved toward eyelet by the forward
advancing of said actuator means.
10. The method of claim 9, wherein cylindrical sleeve is disposed
with 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 fastening loop.
11. The method of claim 10, wherein the cross-section of the
forward section of hook is configured roughly one-third flatter
than the cross-section of the shaft and exhibits play when fitted
into the second longitudinal groove of cylindrical sleeve.
12. The method of claim 8, wherein a blade is disposed at the gap
formed behind hook at the distal end.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application is a divisional application of U.S.
patent application Ser. No. 11/271,752, filed Nov. 14, 2005, the
contents of which is herein incorporated by reference in its
entirety.
[0002] The present invention relates to an occlusion device and a
surgical instrument for the implantation/explantation of an
implant.
BACKGROUND OF THE INVENTION
[0003] 1. Field of the Invention
[0004] 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.
[0005] 2. Description of the Related Art
[0006] 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 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.
[0007] 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.
[0008] 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 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.
[0009] 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.
[0010] 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.
[0011] 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 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.
[0012] 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.
[0013] 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 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 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.
[0014] An occlusion device made of wire braiding is furthermore
known from WO 95/27448 A1. 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.
[0015] The problem therefore set out for the present invention is
to refine such a braided self-centering 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
[0016] 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.
[0017] 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.
[0018] 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.
[0019] 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 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 insertion 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.
[0020] 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.
[0021] 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 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.
[0022] 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.
[0023] 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.
[0024] Three alternative embodiments are herewith proposed for
configuring the holder of the occlusion device in accordance with
the invention.
[0025] Firstly, the head section of the holder can be configured as
a spherical head whereby the inside of the 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.
[0026] 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.
[0027] 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 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 configuration to the cut discharge surface of the
cross-hole entails less material and weight.
[0028] 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 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.
[0029] 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 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.
[0030] 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.
[0031] 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.
[0032] 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 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.
[0033] 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.
[0034] 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.
[0035] 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 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.
[0036] 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.
[0037] 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.
[0038] 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.
[0039] 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.
[0040] 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.
[0041] 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.
[0042] 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
[0043] 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 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.
[0044] FIG. 1 shows a side view of a first embodiment of an
occlusion device with a surgical instrument associated therewith in
accordance with embodiment 1;
[0045] FIG. 2 shows an enlarged sectional representation of the
partial "A" section pursuant to FIG. 1;
[0046] FIG. 3 shows a perspective representation of an occlusion
device embodiment;
[0047] FIG. 4 shows an enlarged side view of a first embodiment of
a holder for the occlusion device;
[0048] FIG. 5 shows a perspective representation of the holder
pursuant to FIG. 4;
[0049] FIG. 6 shows an enlarged detail view of the gripper tongs of
an occlusion device including guidewire and holder;
[0050] FIG. 7 shows a view of the forward section of the surgical
instrument and an occlusion device having a loop pulled through
same;
[0051] 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;
[0052] FIG. 9 shows a sectional detail view of the forward section
of the surgical instrument with the occlusion device at the
insertion filament/wire pursuant to FIG. 8;
[0053] FIG. 10 shows an enlarged side view of a holder of an
occlusion device in accordance with embodiment 2;
[0054] FIG. 11 shows a perspective representation of the holder
pursuant to FIG. 10;
[0055] FIG. 12 shows a simplified view of the forward section of
the surgical instrument with gripper tongs, insertion
thread/guidewire and occlusion device;
[0056] FIG. 13 shows an enlarged detail view of the "A" section
pursuant to FIG. 12;
[0057] FIG. 14 shows a view of the forward section of the surgical
instrument with gripper tongs and occlusion device with hooked
guidewire loop;
[0058] FIG. 15 shows a compressed sectional representation of a
surgical instrument with hooked occlusion device in accordance with
embodiment 3;
[0059] FIG. 16 shows a sectional detail view pursuant "B" from FIG.
15;
[0060] FIG. 17 shows a section through the forward section of the
surgical instrument with coupled occlusion device;
[0061] FIG. 18 shows an enlarged side view of the holder of an
occlusion device in accordance with embodiment 3;
[0062] FIG. 19 shows a perspective representation of the holder
pursuant to FIG. 18;
[0063] FIG. 20 shows an enlarged perspective representation of the
cylindrical sleeve in accordance with embodiment 3;
[0064] FIG. 21 shows an enlarged perspective representation of the
hook pursuant to FIG. 17;
[0065] 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;
[0066] FIG. 23 shows a perspective representation similar to that
of FIG. 22; and
[0067] 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
[0068] 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 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.
[0069] 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 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.
[0070] 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 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 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.
[0071] FIG. 4 shows an enlarged side view of a first 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.
[0072] 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 holder 10.
[0073] 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
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.
[0074] 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.
[0075] 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.
[0076] 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.
[0077] In a first step, loop 117 of insertion thread/guidewire 116
is guided through eyelet 16 of holder 10 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
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 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.
[0078] 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 thread/guidewire 116 to head section 14 of
holder 10 will be described in the following by making reference to
FIGS. 10 and 11.
[0079] FIGS. 10 and 11 show an enlarged side view (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, 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.
[0080] 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.
[0081] 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.
[0082] 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).
[0083] 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.
[0084] 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.
[0085] 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
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 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 surgical suture may also
be used.
[0086] 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 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 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 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 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.
[0087] 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).
[0088] 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.
[0089] 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.
[0090] 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.
[0091] 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).
[0092] 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 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.
[0093] 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.
[0094] 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:
[0095] 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. 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.
[0096] 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.
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