Note: Descriptions are shown in the official language in which they were submitted.
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VESSEL LIP ATTACHMENT
RELATED APPLICATIONS
The present application is related to the following PCT applications filed by
applicants
Bypass Inc., et al., PCT/IL99/00285, PCT/IL99/00284, PCT/IL99/00674,
PCT/IL99/00670,
PCT/IB00/00302 and PCT/IB00/00310, and an application filed on even date as
the instant
application, in the Israel Receiving Office of the PCT, titled "ANASTOMOTIC
DEVICES
AND METHODS", attorney docket 088/01579, all of which designate the US, the
disclosures
of which are incorporated herein by reference.
FIELD OF THE INVENTION
The present invention relates to the manipulation of vessel hole lips,
especially for
effecting anastomosis connections.
BACKGROUND OF THE INVENTION
Eversion of vessel lips is typically performed outside the body, for example
as
described in US patents 5,366,462 and 5,695,504, the disclosure of which is
incorporated
herein by reference. However, the lips of a hole in an aorta cannot be thus
manipulated, since
the aorta must remain in the body.
SUMMARY OF THE INVENTION
An aspect of some embodiments of the invention relates to eversion of the lips
of a
hole in a blood vessel, for example so that they are engaged by an anastomotic
connector or a
hole closure device. In an exemplary embodiment of the invention, a puller is
used to retract
the lips into the connector. Optionally, the puller is removable, for example
being part of a
device delivery system. Alternatively. the puller may remain in the
connection. Alternatively,
no puller is used, for example, a change in the device geometry causing the
lips to be retracted.
Alternatively to retraction into the device, the retraction is into the
delivery system, after
which the anastomotic device is applied. The delivery system, in some
embodiments of the
invention, guides the retraction.
The pullers may be used in various types of vascular devices, whereby the
pullers bring
the lips of the blood vessel into a desired location relative to another lip
or a device, and
optionally hold the lip in place, or move it, during an operation of the
device. Where a
plurality of pullers are provided, the pullers may, for example, act
simultaneously or in
sequence.
The anastomotic device may have, for example, one part, two parts or may
compnse a
plurality of independent (or attached by a thread) clamping elements.
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The retracted lips may be pressed against each other to prevent blood leakage.
Alternatively, they may be pressed against a part of the device.
An aspect of some embodiments of the invention relates to a method of
attaching two
blood vessel usin; multiple clips. In an exemplary embodiment of the
invention, the lips of the
rivo blood vessels are evened and the clips are closed onto the evened part,
so that the clips
remain outside the blood vessels and there is an intima-to-intima connection
between the blood
vessels. In some embodiments of the invention, the lips are evened using hooks
that transfix
the lips. Alternatively, the hooks do not transfix the lips.
There is thus provided in accordance with an exemplary embodiment of the
invention,
a vascular attachment device for sealing an opening between two blood conduit
lips,
comprising:
at least one clip element adapted for sealing at least a portion of an opening
between
two blood conduit lips; and
at least one puller adapted for pulling, inside the body, at least one of said
lips into said
clip element.
Optionally, said puller is attached to said device. Alternatively, said puller
is not
attached to said device.
In an exemplary embodiment of the invention, said puller is adapted to remain
in a
body after use. Alternatively, said puller is adapted to be removed from a
body after use.
In an exemplary embodiment of the invention, said puller is bio-absorbable.
In an exemplary embodiment of the invention, said puller is adapted to
penetrate said
lip. Alternatively or additionally, said puller is adapted to transfix said
lip. Alternatively, said
puller is adapted to not penetrate said lip.
In an exemplary embodiment of the invention, said puller is adapted to be
distorted by
said clip. Optionally, said distortion assists in a removal of said puller
from said seal
In an exemplary embodiment of the invention, said at least one puller
comprises a
single puller adapted to pull both of said lips. Alternatively, said at least
one puller comprises
two pullers, each adapted to pull one of said lips.
In an exemplary embodiment of the invention, said puller is attached to a
thread, for
retracting said pulley. Optionally, said pulley is distorted by said
retracting, while pulling said
lip into said clip.
In an exemplary embodiment of the invention, said at least one clip comprises
a
plurality of clips cooperating to seal said opening. Optionally, said
plurality of clips are not
connected to each other. Alternatively, said plurality of clips are
interconnected. Optionally,
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said plurality of clips are rigidly interconnected. Alternatively, said
plurality of clips are
flexibly interconnected.
In an exemplary embodiment of the invention, said clip does not distort to
effect said
seal. Alternatively, said clip distorts to effect said seal. Optionally, said
clip comprises two
arms the bend towards each other to effect said seal. Alternatively or
additionally, said clip
distorts plastically. Optionally, said device comprises a delivery system
comprising a contra
element and a pressure element, which tvvo elements compress said clip between
them.
In an exemplary embodiment of the invention, said clip self distorts.
Optionally, said
device comprises a delivery system comprising a restraining element adapted to
selectively
release said clip, to self distort.
In an exemplary embodiment of the invention, said clip comprises barbs, for
engaging
said lips. Alternatively or additionally, said clip comprises protrusions, for
engaging said lips.
In an exemplary embodiment of the invention, said clip comprises a slot, for
engaging
said lips.
In an exemplary embodiment of the invention, said clip is adapted to seal said
lips
against each other. Alternatively or additionally, said clip is adapted to
seal said lips against a
part of said clip.
In an exemplary embodiment of the invention, said clip compresses said lips,
to effect
said seal.
In an exemplary embodiment of the invention, said lips are lips of a same
conduit.
Alternatively, said lips are lips of two different conduits.
In an exemplary embodiment of the invention, at least one of said conduits is
an in-
vivo blood vessel. Alternatively or additionally, at least one of said
conduits is a synthetic
graft.
There is also provided in accordance with an exemplary embodiment of the
invention,
a method of sealing an opening between t<vo blood conduit lips, comprising:
providing a clip;
first retracting a first lip into said clip; and
second retracting a second lip into said clip. Optionally, the method
comprises closing
said clip to seal said opening. Optionally, closing comprises releasing said
clip to self deform.
Alternatively or additionally, closing comprises plastically deforming said
clip.
In an exemplary embodiment of the invention, said first and second retracting
are
performed simultaneously. Alternatively. said first and second retracting are
performed using a
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single puller. Optionally, said puller has a single lip engaging element.
Alternatively, said
puller has at least two lip engaging elements.
In an exemplary embodiment of the invention, said first and second retracting
are
performed using at least two pullers.
In an exemplary embodiment of the invention, the method comprises retracting
said
puller from said seal. Alternatively, the method comprises leaving said puller
in said seal.
In an exemplary embodiment of the invention, the method comprises providing a
pharmaceutical at said seal. Optionally, said pharmaceutical comprises a clot
prevention
pharmaceutical. Alternatively, said pharmaceutical comprises a clot enhancing
pharmaceutical.
In an exemplary embodiment of the invention, providing comprises providing a
layer
of material comprising said pharmaceutical. Optionally, said layer is provided
between said
lips
In an exemplary embodiment of the invention, said two lips are lips of an
opening in a
single conduit. Alternatively, said ttvo lips are lips of different conduits.
In an exemplary embodiment of the invention, at least one of the conduits
comprises a
blood vessel.
BRIEF DESCRIPTION OF THE FIGURES
Non-limiting embodiments of the invention will be described with reference to
the
following description of exemplary embodiments, in conjunction with the
figures. The figures
are generally not shown to scale and any measurements are only meant to be
exemplary and
not necessarily limiting. In the figures, identical structures, elements or
parts which appear in
more than one figure are preferably labeled with a same or similar number in
all the figures in
which they appear, in which:
Figs. lA-1D illustrate a blood vessel attachment method and apparatus, in
accordance
with an exemplary embodiment of the invention;
Fig. 1E is a top view of a clip suitable for the method illustrated in Figs.
lA-1D;
Figs. 2A-2B illustrate a blood vessel attachment method, in accordance with an
alternative exemplary embodiment of the invention;
Fig. 2C illustrates an alternative blood vessel attachment device, in
accordance with an
alternative exemplary embodiment of the invention;
Fig. 2D illustrates an alternative clip, in accordance with an exemplary
embodiment of
the invention;
Figs. 3A-3D illustrate a hole-closure device based on a clip-puller
combination, in
accordance with an exemplary embodiment of the invention;
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Fig. 4 illustrates a mufti-clip connector, in accordance with an exemplary
embodiment
of the invention;
Figs. SA-~F illustrate a method of deploying the clip of Fig. 4, in accordance
with an
exemplary embodiment of the invention;
Figs. 6A-6C illustrate an alternative method of deploying multiple clips in an
anastomotic connection, in accordance with an exemplary embodiment of the
invention; and
Figs. 7A-7C illustrate the deployment of other clip-devices for the attachment
of two
blood vessels, in accordance with exemplary embodiments of the invention.
DETAILED DESCRIPTION OF ENEMPLARY EMBODIMENTS
Figs. lA-1D illustrate a blood vessel attachment method, in accordance with an
exemplary embodiment of the invention. In Fig. lA, an end-vessel 100 and a
side vessel 102
are attached together using a clip 104. Clip 104 comprises a first arm 106
having a vessel
engaging means, for example a barb 108, for engaging vessel 100, and a second
arm 110,
having a vessel engaging means such as a barb 112 for engaging vessel 102. In
this and in
other embodiments, the blood vessels and/or grafts may be part of the natural
vasculature,
synthetic, autologus, xenologus, cadaver grafts and/or any other type of blood
conduit.
In Fig. lA the two vessels are engaged by the barbs, such that a lip 114 of
vessel 100 is
engaged by barb 108 and a lip 116 of vessel 102 is engaged by barb 112. The
two lips may
abut or there may be a space between them.
In Fig. 1B, clip 104 is folded so the intima portions of the two lips are
pressed against
each other by the two arms of the clip. The barbs prevent an inadvertent
release of the vessel
lips during the conformance change and/or provide stability after the
connection is completed.
The conformance change of the clip may be effect in various ways, for example
elastically, super-elastically or using a shape memory clip, in which cases no
external forces
may be required. Alternatively, clip 104 is plastically deformed.
Although clip 104 is shown in Fig. lA having an angle greater than 180°
between the
arms holding the barbs, in some embodiments, clip 104 is flat or has an angle
smaller than
180°, so that the clip can be squeezed shut using a pliers or a
clamping scissors. The angle
between the arms may affect the ease of mounting the lips of the vessels onto
the barbs.
Figs. 1C and 1D illustrate the use of a puffer for retracting the vessel lips
onto the
barbs. Fig. 1C shows a puffer 120 including a curved tip 122 for pulling lip
114 of vessel 100
onto barb 108. Fig. 1 D shows a puffer 124 including a curved tip 126 for
pulling lip 116 of
vessel 102 onto barb 112. Alternatively, other methods of mounting may be
used, for example
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manual mounting. An exemplary device for carrying out the method of Figs. 1C-
1D is
described below.
In some embodiments of the invention, tip 126 (and 122) is sharp.
Alternatively, tip
126 may be blunt, for example to prevent penetration of the tip into the blood
vessel wall
engaged by the tip. Tip 126 may also be forked, for example, to prevent over
penetration of the
tip into the blood vessel wall.
Although the above clip is shown for use on side-to-end anastomosis
connections, it
may also be used for other types of connections, for example, end-to-end
connections and side-
to-side connections.
Fig. 1E is a top view of a clip suitable for the method illustrated in Figs.
lA-1D. In this
exemplary embodiment, clip 104 comprises an elliptical ring, one side of which
is arm 106 and
the other side of which is arm 110. The barbs are formed at the apexes of the
ellipse. Two
cross-bars 130 are provided to allow the clip itself to be used as a pivot for
pulleys 120 and
124. In an alternative embodiment, clip 140 is bar shaped. As will be
described below, a
complete anastomosis may require several such clips, or a multi-clip
connector.
Figs. 2A-2B illustrate a blood vessel attachment method, in accordance with an
alternative exemplary embodiment of the invention. A clip 204, which may be
the same as clip
104 of Fig. 1, is mounted on vessel 100 and 102. A single pulley 220 including
two barbs 222
and 226, one for each vessel is shown instead of two separate pulleys. This
pulley is optionally
used for mounting the vessels on clip 104 of Fig. 1. A contra element 232,
comprising two
spaced apart portions is placed behind clip 104, opposite from barbs 222 and
226. When pulley
220 is retracted towards contra element 232, clip 204 is pulled between the
contra element
portions and bend, thus clamping the two blood vessel lips between the arms.
The resulting
completed connection is shown in Fig. 2B. Contra element 232 optionally
includes an
extension 236 on one or both portion, to prevent over retraction of clip 204.
Optionally, contra
elements 232 are brought closer together, to further seal the anastomosis by
bending clip 204.
Contra elements 232 may be removed after the procedure is completed such that
only clip 204
stays in the body.
Pulley 220 may be cut at point 234, thus keeping barbs 222 and 226 inside the
anastomosis connection. Possibly, the barbs are bio-absorbable. Alternatively
or additionally,
the barb includes a tissue bonding enhancing material. Alternatively or
additionally, the barbs
are pulled out of the vessels, possibly tearing the lips of the vessel, at
portions outside of the
connection area. In one embodiment of the invention, the barbs are shorter
than the thickness
of the vessel wall, so the tear is not complete. Possibly, barbs 222 and 226
soften at body
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temperature or in a liquid or electrolytic environment, allowing them to be
pulled out.
Alternatively barbs 222 and 226 are bent back by bars 130 (Fig. 1E) allowing
them to be more
easily retracted. Alternatively or additionally, barbs 222 and 226 are not
sharp and do not
penetrate the vessel wall, but merely pull it back and then can slide past the
wall, possibly
deforming, and out of the connector. Alternatively or additionally, pulley 220
may be
connected to the rest of the clip, for example, using a thread or wire.
Fig. 2C illustrates an alternative blood vessel attachment device 240, in
accordance
with an alternative exemplary embodiment of the invention. Device 240
comprises a clip 242
and a pulley 244, generally similar to clip 104 and clip 204. However, clip
242 is pre-bent.
Thus, pulley 244 is required to pull the tissue lips into a narrow space 246
formed between the
two arms of clip 242. Barbs 248 can prevent retraction of the lips, once
pulled into space 246.
In some embodiments of the invention, space 246 includes a wall (not shown)
that divides the
space into two spaces, one for each lip. Alternatively or additionally to a
wall, a gauze, pad or
bioabsorbable material may be provided as a layer between the two lips and/or
between the
lisp and the device. In an exemplary embodiment of the invention, the layer
elutes heparin or
other blood coagulation promoters or antagonists, for example, to prevent
clots or to promote
clotting of leakage blood. Other pharmaceuticals maybe provided as well. The
pharmaceutical
may be soaked in the layer, or, for example, it may be trapped in a matrix, so
that it is slowly
released over time.
Fig. 2D illustrates an alternative clip 252, in accordance with an exemplary
embodiment of the invention. The above described clips, for example that of
Fig. 1E have
opposing arms. However, this is not required. Clip 252 has one arm 253 on one
side of a base
256 and two arms 254 on an opposite side. A matching asymmetric pulley 250 is
also shown,
that has two pulley barbs 260 opposing a single pulley barb 260, on a thread
262. Arms 253 and
254 may include barbs, as described above. However, in an exemplary embodiment
of the
invention, the vascular tissue is pinched between the two arms 254, possibly
being forced into
the space between arms 254 by arm 253. Optionally, the arms extend at an
angle, so the space
between the arms is more wedge shaped. Possibly, the distance between the arms
is shorter
than the combined width of the two target blood vessels. Alternatively or
additionally, arms
254 can be elastically distorted, to accommodate a vreater width of tissue.
Figs. 3A-3D illustrate a hole-closure device 300 based on a clip-pulley
combination, in
accordance with an exemplary embodiment of the invention. Although Figs. l and
2 are
described with reference to attaching two lips from different blood vessels,
similar principles
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may be applied to vascular hole closure, in which the two lips that are sealed
together are from
a same blood vessel.
Fig. 3A shows a hole closure device 300, in a layout view. In Fig. 3B, device
300 is
folded, such that it has a base 302 and t<vo arms 304, each arm having one or
more barbs 306
at its ends.
Fig. 3C shows a device 300 being deployed. In an exemplary embodiment of the
invention, device 300 is held against a vessel 312, adjacent a hole 310
therein, by a contra-tube
320, which may be hollow. Alternatively, device 300 may be mounted on tube
320. Hole 310
has lips 318 and 320, that can be pulled into device 300, by a puffer 314.
Possibly, puffer 314
is pulled using a thread or wire 316, which optionally extends through tube
320.
Fig. 3D shows hole 310 after puffer 314 pulls lips 318 and 320 into device
300. Puffer
314 (which may remain in the connection) is not shown, for example being
retracted (possibly
through the hole in base 302, optionally after being bent back by contact with
base 302 itself)
or being absorbed, as described above. Device 300 may be sized to fit various
hole sizes and
blood vessel thickness. Alternatively or additionally, a flat device, for
example as shown in
Fig. 3A is bent, on the spot, to match desired hole closure characteristics.
Although device 300
is shown with two barbs 306 on each arm, a greater or smaller number of barbs
may be
provided, possibly not opposing barbs, or even protrusions (not sharp) instead
of barbs. The
length of the device may depend, for example on the size of hole 310.
Alternatively or
additionally, a plurality of devices 300 are applied size by side.
Similarly, the clips of Figs. 1-2 may be provided as individual clips, for
example, one
by one or using a mufti-clip delivery system, for example for simultaneous
delivery. Typically,
several clips are required for connecting two blood vessels together, for
example, 3, 4, 5, 6 or
more clips. Alternatively, the clips may be connected together, for example
using a thread or a
ring, to form a single anastomosis connector (or hole closure device).
Alternatively, previously
described connectors and hole closure devices (e.g., in the above PCT
applications) may be
segmented to provide clips, for example each clip comprising two opposing
spikes and an
optional ring section.
Alternatively or additionally to bending of the spikes/arms, a torsion bar
mechanism
may be provided for rotation of the arms. In an exemplary embodiment of the
invention, base
256 of clip 252 in Fig. 2D ca~~ serve as a torsion bar, that twists
alternatively or additionally to
bending of arms 254 and 253. Clip 252 can then be a pressure based clip, which
simply
forcefully contacts two vascular tissues.
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Fig. 4 illustrates a mufti-clip connector 400, in accordance with an exemplary
embodiment of the invention. Connector 400 comprises a ring 402 having a
plurality of "side"
engaging clips arms 404 and an opposing plurality of "end" engaging clip arms
406. As
shown, opposing clips arms do not need to have a same radial position,
however, that is
possible. Alternatively or additionally, the number of "side" and "end" clip
arms may be
different. Alternatively or additionally, the connector may be used for two
"side" vessel or for
two "end" vessels. As shown the clip arms are not designed to penetrate the
vessel walls,
however, in some embodiments, at least some of the clip arms may penetrate the
vessel walls,
such arms may include a fork design or a protrusion distal from their tip, to
prevent over
penetration and/or motion of the vessel wall along the arm. The clip arms on
opposing sides
may have the same or a different general design. Alternatively or
additionally, the clip arms on
a same side of ring 402 may also be the same (as shown) or different, for
example alternating
clip arms having different designs.
Figs. SA-SF illustrate a method of deploying the clip of Fig. 4, in accordance
with an
exemplary embodiment of the invention. In these figures, not all the repeating
elements are
shown, to reduce visual clutter. System 500 may be deployed, for example in
open surgery, in
endoscopic or throactoscopic surgery and/or in a transvascular approach.
Fig. 5A illustrates a delivery system 500 having mounted therein a graft 502
and a
connector 400. The view is a cross-sectional view selected so that the
operation of one "side"
arm 404 and one "end" arm 406 are clearly visible.
System 500 includes an outer contra tube 506 and an inner pusher tube 504.
Connector
400 is held, for example elastically or by friction, by outer contra tube 506.
An outer base tube
508 is provided for closing the "side" arms, as will be described below. A
plurality of "side"
vessel puffers 512 are provided through apertures 514 formed in outer tube
506. A plurality of
"end" vessel puffers 510 are provided through apertures 516 formed in outer
tube 506. In an
exemplary embodiment of the invention, arms 504 and 506 are staggered, so that
apertures 514
and S 16 are staggered to match the arm locations. The tips of the puffers may
or may not be
aligned with the arms into which they pull vascular tissue. In some
embodiments, at least some
of the puffers may be non-planar.
In Fig. ~B, "end" puffers 510 are retracted, pulling the lips of graft 502
against clip
device 400. This step may be performed inside the body or outside of it.
Fig. SC shows system X00 near a target side vessel 520. Target vessel 520 may
be, for
example, a coronary artery, a synthetic or biological graft, an aorta, a LIMA,
a coronary vein,
an aorta or a peripheral blood vessel, such as a femoral artery or a leg vein,
or any other known
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blood conduit. Also graft X02 may be any known blood conduit. Pullers ~ 12 are
extended
forward so that they enter an opening in vessel X20. In some embodiments of
the invention, the
insertion of pullers ~ 12 is manual. In others, it is facilitated by an
alignment of system 500 and
the hole in the target vessel. It is noted that a punch for forming the
opening may be provided
through outer base tube X08 and then replaced with the graft delivery portion.
Alternatively, a
punch may be provided through graft 502. Alternatively, a separate punching
tool is used.
Alternatively, an incision is made using a knife.
In Fig. SD, pullers ~ 12 are retracted, pulling the lips of the incision of
vessel 520 into
the clip, so that the lips of the two vessels are near, touching or
overlapping each other.
In Fig. SE, a proximal inwards pointing portion 522 of base X08 is pushed
inwards,
causing arms 404 to close on the lips of vessel 520, and in the process
possibly also everting
them further. Portions 522 may include an inclined portion X26 for guiding the
arms to close in
a desired fashion. One exemplary method of moving portions 522 is advancing an
outside tube
524 over base outer tube 508, causing it to radially compress. Although puller
512 may be
distorted during the closing of arms 404, this is generally of no consequence.
In Fig. 5F, inner pusher tube 504 is advanced, closing arms 406 of clip 404.
Base tube
508 may serve as a contra for the pressure. The blood vessels are thus held
securely between
arms 404 and 406, preferably preventing blood leakage.
In some embodiments of the invention, the steps of Figs. SE and SF are
performed
simultaneously or in an a opposite order. Although simultaneous performance
for all the arms
on a side is preferred, in some embodiments, not all the arms on a single side
are closed
together.
The anastomosis being completed, pullers 512 and 510 may be retracted and base
tube
508 can be radially expanded, to release clip 400. Inner tube X04 may be
advanced further to
release clip 400 from outer tube 506. Alternatively, the pullers may be dealt
with as described
above, for example, cut and left in the body, possibly to be absorbed.
The above, described the deployment of a plastically deployed device. In an
elastic,
shape-memory or super-elastic device, a similar delivery system may be used.
For example,
base tube X08 may include barbs or an inner lip for maintaining arms 404 open
(until base tube
508 is advanced) and inner tube X04 may include an extension for preventing
arms 406 from
closing (until inner tube 504 is retracted). Even in a plastically deforned
device 400, ring 402
may be elastic, for example to allow radial compression for deployment and/or
for being held
by outer tube 506.
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Although Fi~~. ~ above and Fig. 6 below describe a side-to-end anastomosis, it
should
be appreciated that a similar mechanism may be used for oblique, side-to-side
and end-to-end
connections. In such connections, the vessel may be aligned in a non-axial
manned to the rest
of delivery system X00, for example, be provided through a lumen that is
perpendicular to the
system axis. However, the general working of the pullers remains the same.
Alternatively or additionally, system X00 is a split system (into two, three
or more
lengthwise parts), so that it can be more easily removed from graft 502.
Figs. 6A-6C illustrate an alternative method of deploying multiple clips in an
anastomotic connection, in accordance with an exemplary embodiment of the
invention.
Fig. 6A shows a graft 602, having a lip 604 transfixed on a puller 606. A
delivery
system 600, mounted on the graft includes an inner tube 620 on which an
anastomotic
connector 608 is mounted. Connector 608 may comprise, for example, a ring 616
and a
plurality of clip arms 618. In an exemplary embodiment of the invention,
connector 608 is
super-elastic, elastic or shape memory, with arms 618 prevented from folding
in by a restraint
7 5 626. In an exemplary embodiment of the invention, an inwardly pointing
extension 610 of
restraint 626 includes a circumferencially pointed (e.g., out of the figure
plane) bump 612 (or
restraint 626 is slotted) that prevents arm 618 from radial motion. When
restraint 626 is rotated
relative to connector 608 or when restraint 626 is radially expanded, arms 618
are released.
Delivery system 600 further comprises a retracting tube 624 for retracting
pullers 606
and a contra tube 622 which prevents retraction of connector 608.
In Fig. 6B, pullers 606 are extended into an incision 634, having lips 632 in
a "side"
vessel 630.
In Fig. 6C, pulleys 606 are retracted, evening lips 632 and pulling both lips
632 and
lips 604 into connector 608. Restraint 626 then releases arms 618, allowing
the connector to
close, sealing the connection between graft 602 and vessel 630. Pulleys 606
are thus generally
not required any more, at least not for holding vessel 630. Pulleys 606 can
then be further
retracted, possibly causing no damage to the blood vessels, as the pulleys are
straightened by
the retraction. Connector 608 can be released, for example by advancing contra
tube 622. In a
plastically deformed embodiment, restraint 626 acts as a anvil, to radially
compress arms 618.
Arms 618 may have sharp tips, as shown. for example to penetrate one or both
of lips
632 and 604. Alternatively, the tips of arms 618 may be blunt, to apply non-
penetrating
pressure. Alternatively, arnls 618 may hold lips 604 against the upper pan of
the connector and
lips 632 against the ring part of the connector.
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It should be noted that while Figs. ~ and 6 illustrate anastomotic connectors,
a similar
delivery system may be used for connecting two lips of a single blood vessel,
for example for
hole closure. In such a case, the connector, instead of being a ring as shown
in Fig. 4, may be a
line connector or a circular connector with arms only on its bottom part,
pointing in.
Figs. 7A-7C illustrate the deployment of other clip-devices for the attachment
of two
blood vessels, in accordance with exemplary embodiments of the invention.
In Fig. 7A, a clip 700 is elastic, super-elastic of shape memory, so that it
desires to
reach a folded shape (i.e., is self closing). A restraint 706, including, for
example a slotted
portion 712 that engages an arm 708 of clip 700, prevents the arm from
closing. Another arm
710 of clip 700 may be held in another slot (or bump) 714. Alternatively, clip
700 is part of a
single connector including a plurality of clips attached to a ring 716, here
shown being held by
a holder 718.
In operation, the lip of a graft 702 is transfixed by arm 708 of clip 700. Arm
708 is
inserted into an incision in a vessel 704 (only one side shown). When
restraint 706 releases
clip 700, the clip closes, sealing together graft 702 and vessel 704. In a
plastically deformed
embodiment, a retraction of restraint 706 may fold arm 708 against arm 710.
Fig. 7B shows an alternative embodiment of the invention, in which a self
closing clip
720 transfixes a graft 702 and a vessel 704. The clip maybe inserted, for
example, manually,
into an incision in vessel 704 and then embedded in the vessel wall by pulling
it back. When a
restraining outer tube 722 is retracted, clip 720 is free to fold. Like clip
700, also clip 720 may
be part of a mufti-clip connector, in some embodiments of the invention.
Fig. 7C shows an alternative embodiment of the invention, in which a clip 730
has the
lips of graft 702 and vessel 704 inserted into it, for example manually or
using a puffer (not
shown). Clip 730 comprises two arms 732 and 734 connected by a base 736. In an
exemplary
embodiment of the invention, clip 730 is pre-stressed so that arms 732 and 734
desire to fold
inwards. Arms 732 and 734 extend past base 736 as extensions 742 and 744,
respectively. A
restraint comprising two opposing restraint elements 738 and 740 engage and
maintain in
position, clip 730, via extensions 742 and 744. Clip 730 is a self closing
clip, in which arms
732 and 734 close towards each other. When restraints 738 and 740 are brought
apart, arms
732 and 734 advance towards each other and engage and seal together the lips
of graft 702 and
vessel 704. In an exemplary embodiment of the invention, restraints 738 and
740 are brought
together in order to enlarge the distance between arms 732 and 734 and make it
easier to insert
the lips of vessel 704 and graft 702 into the clip. Possibly, clip 730 is laid
against the vessel
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CA 02393486 2002-06-03
WO 01/41624 PCT/IL00/00611
and the graft and as the restraints are let apart, the tips of arms 732 and
734 engage and
advance the lips into the clip.
The above devices may be varied in various ways, for example for adaptation
for
specific types of blood conduits. In some embodiments of the invention, a
device is packaged
and/or sold with an instruction leaflet, describing the device dimensions
and/or situations for
which the device should be applied.
One or more of the following parameters of a device may be varied, for
example:
(a) Number of barbs in an arm of a clip. Although only one barb is shown, two,
three or
more barbs may be provided.
(b) Location of barbs along the arm. Although the barbs are shown at the tip
of the arm,
they may be positioned further in. In devices with multiple barbs, the barbs
may be positioned
side by side or one in front of the other, for example.
(c) Shape of arms. Various shapes may be provided, for example, rectangular,
triangular, arcuate, circular and piecewise linear or curved. The arms may be
planar or may
extend outside of a plane, for example being curved.
(d) Length of barbs. The barbs may be long enough to transfix the vessel
walls.
Alternatively, they may be made shorter, for example penetrating only some of
the layers of
the blood vessel. It is noted that different barbs on a same device may have
different lengths or
other properties, for example, depending on the properties of the target
vessels. Exemplary
lengths include, 0.1 mm, 0.5 mm, 1 mm, 2 mm and larger, smaller and
intermediate sizes.
Other parameters of the barb design may vary as well, for example the degree
of sharpness
(sharp vs. blunt).
(e) Length of arms. The length of the arms may also depend on the properties
of the
target vessels and the geometry of the connection. Exemplary lengths include,
1 mm, 3 mm, 5
mm, 7 mm and larger, smaller and intermediate sizes.
(f) Existence and dimensions of base. Although not all devices include a base,
the
length of the base may be, for example, 1 mm, 3 mm, S mm, 7 mm and larjer,
smaller and
intermediate sizes. The width of the base (between two arms) may be, for
example, 0.5 mm, 1
mm, 3 mm, ~ mm and larger, smaller and intermediate sizes.
(g) Existence and geometry of lumen. In devices with a central lumen, the
shape of the
lumen and the punched hole may be vary, for example being circular, elliptical
or polygonal.
(f) Solidity of device. Although the device may have a continuous surface, in
some
embodiments of the invention, for example as shown in Figs. 3A and 1E, one or
more holes
may be formed in the surface of the device. This may reduce the total amount
of foreign
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CA 02393486 2002-06-03
WO 01/41624 P~T/IL00/00611
material in the body. It is noted, however, that the total amount of material
in the blood flow
may be very low or even zero, in some embodiments of the invention.
It will be appreciated that the above described methods and devices of
vascular
manipulation may be varied in many ways, including, changing the order of
steps, which steps
are performed inside the body and which outside, the order of making the
anastomosis
connections, the order of steps inside each anastomosis, the exact materials
used for the
anastomotic connectors, which vessel is a "side" side and which vessel (or
graft) is an "end"
side of an end-to-side anastomosis and/or whether two lips that are connected
are from a same
vessel or from different vessels. Further, in the mechanical embodiments, the
location of
various elements may be switched, without exceeding the sprit of the
disclosure, for example,
switching the moving elements for non-moving elements where relative motion is
required. In
addition, a multiplicity of various features, both of methods and of devices
have been
described. It should be appreciated that different features may be combined in
different ways.
In particular, not all the features shown above in a particular embodiment are
necessary in
every similar exemplary embodiment of the invention. Further, combinations of
the above
features, from different described embodiments are also considered to be
within the scope of
some exemplary embodiments of the invention. In addition, some of the features
of the
invention described herein may be adapted for use with prior art devices, in
accordance with
other exemplary embodiments of the invention. The particular geometric forms
used to
illustrate the invention should not be considered limiting the invention in
its broadest aspect to
only those forms, for example, where a circular lumen is shown, in other
embodiments an oval
lumen may be used.
Also within the scope of the invention are surgical kits which include sets of
medical
devices suitable for making a single or a small number of anastomosis
connections.
Measurements are provided to serve only as exemplary measurements for
particular cases, the
exact measurements applied will vary depending on the application. When used
in the
following claims, the terms "comprises", "comprising", "includes", "including"
or the like
means "including but not limited to".
It will be appreciated by a person skilled in the art that the present
invention is not
limited by what has thus far been described. Rather, the scope of the present
invention is
limited only by the following claims.
14
