Note: Descriptions are shown in the official language in which they were submitted.
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ANASTOMOTIC DEVICES AND 1IETHODS
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 "VESSEL LIP
ATTACHMENT",
attorney docket 088/01642, 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 field of attaching two blood conduits to
each other.
BACKGROUND OF THE INVENTION
The need to connect two blood vessels or a blood vessel and a graft is well
known. It is
often desirable to perform an intima-to intima connection between the two
vessels. However,
this may require eversion of one of the blood vessels. Eversion is generally
considered a
difficult and demand task.
A sub-task of eversion for some types of anastomotic devices is proper
penetration of
the evened vessel by sharp spikes of the anastomotic connector.
SUMMARY OF THE INVENTION
An aspect of some embodiments of the invention relates to treating the vessel
tissue of
at least one of the vessel of an anastomotic connection, as a non-passive
tissue. Thus, various
properties of the tissue are taken into account and/or utilized as pan of
anastomotic
connection, including, for example, elasticity, plasticity and/or
compressibility.
An aspect of some embodiments of the invention relates to distorting a graft
or blood
vessel (hereinafter the teen graft is used for either or both), to simulate
eversion and/or
shaping of the graft tip. In an exemplary embodiment of the invention, the end
of the graft is
thickened to allow spikes of anastomotic device to transfix the graft parallel
to its axis. These
spikes may also maintain the thickening of the graft. Alternatively or
additionally, the tip is
stretched, to thin its wall. Alternatively or additionally, the end of the
graft is compressed so
that an intima portion of the graft is presented to the front or outside of
the compressed graft.
Alternatively or additionally, the graft is distorted so that it supports a
non-perpendicular
anastomosis, by an elastic desire of the graft to return to a less-distorted
shape. Possibly, the
angle of the connection and/or tendency to kink is modified by appropriate
shaping of the
graft.
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In an exemplary embodiment of the invention, the compression and/or other
distortion
of the graft is performed by the anastomotic connector. Alternatively or
additionally, the
distortion is performed by a separate tool. Alternatively or additionally, the
distortion is
performed by a delivery system.
The anastomotic connections may be, for example, side to side, side to end or
end to
end. In an exemplary embodiment of the invention, an aorta is axially
compressed about a
holed formed therein, to assist in evening the lips of the hole and/or
distorting the lips of the
hole. Alternatively or additionally, to distorting the lips for an anastomotic
connection, such
distortion may be applied to lips of a hole in a blood vessel, for example to
effect a better seal.
An aspect of some embodiments of the invention relates to controlling a shape
of an
anastomosis connection using an anastomosis device and/or a graft that take
part in the
connection. In an exemplary embodiment of the invention, the connection is
made at a
perpendicular angle and then the connection is modified, for example self
modified, to a new,
oblique orientation.
In an exemplary embodiment of the invention, the anastomosis connector accepts
bending after being deployed. Possibly, even relatively small forces suffice
to bend the
connector, for example, forces applied by the graft or by an external tool.
An aspect of some embodiments of the invention relates to reducing a profile
(e.g.,
projection from a surface of a blood vessel) of an anastomosis connector after
it is attached. In
an exemplary embodiment of the invention, the profile is reduced by one or
more of cutting,
bending, twisting and/or bucking of parts of the connector. It is expected
that, at least in some
cases, the reduced profile will reduce the incidence of kinking of the graft.
Alternatively or
additionally, the pre-stressing of the graft will assist in reducing kinking.
An aspect of some embodiments of the invention relates to a vessel punch
having
mounted thereon an anastomotic connector. In an exemplary embodiment of the
invention, the
act of punching inserts the connector into the vessel, so that once it is
released from the punch,
the anastomosis can be completed. In an exemplary embodiment of the invention,
the
connector is released by rotating the punch relative to the connector.
An aspect of some embodiments of the invention relates to methods of
manipulation of
a graft to achieve a desired eversion, which eversion is penetrated by spikes
of a connector. In
an exemplary embodiment of the invention, the manipulation consists of
eversion.
Alternatively or additionally, the manipulation consists of converting a
straight eversion into
an oblique eversion, so as to pre-stress the connector so that a completed
anastomosis will be
oblique. Alternatively or additionally, the manipulation consists of method of
advancing the
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spikes to transfix the graft. It should be noted that in some embodiments of
the invention, the
spikes on the connector are not perpendicular to the graft at the penetration
point.
In an exemplary embodiment of the invention, the spikes are assisted in
penetrating the
graft by suddenly releasing the spikes form a constraint, inside the evened
part of the graft.
Sudden release can be, for example, by releasing a lasso that holds the spikes
radially
compressed, by retracting an outer tube that confines the spikes or by
rotating a slotted tube
mounted over the connector, so that the spikes are released into the slots,
simultaneously or in
sequence.
In another exemplary embodiment of the invention, the spikes penetrate the
graft with
the help of a cap, mounted on the graft. For example, the cap can be condom-
like, including a
portion that extends into the lumen of the graft and a flexible membrane that
can be inverted
over the graft, evening the end of the graft with it. Alternatively, the cap
can be a rigid cap.
Twisting the cap on an evened graft will cause the spike tips to penetrate the
graft, if they have
not yet penetrated. Alternatively or additionally, the cap has uneven sides,
for example
including barbs, to unevenly pull-down the two sides. The spikes may be
restrained by a lasso
or over tube, during the pulling down of the cap.
In another example embodiment of the invention, the graft is mounted on a
mold,
which support uneven eversion, for example, using tweezers. In an exemplary
embodiment of
the invention, the mold comprises a cylinder with two axially extending and
adjacent fingers.
One spike of the connector rest between the fingers. During eversion, the tip
of the vessel is
brought over the finger and onto the spike. Alternatively to using tweezers
and a special mold,
an external tool is used, for example a pad having an inwards pointing barb.
The pad slides
along a tube enclosing the graft and the barb selectively engages only that
part of the graft that
is to be pulled down, thus stretching only that pan.
In other embodiments of the invention, a manual probe is used to ensure that
all the
spikes penetrate the graft. In an exemplary embodiment of the invention, the
probe is a Y
shaped probe with a wire between the two prongs of the Y. This wire can be
used to urge the
graft, adjacent the spike tip, onto the spike. Alternatively or additionally,
this wire is used to
push back the spike, so that it can be suddenly released to penetrate the
graft.
An aspect of some embodiments of the invention relates to an angular eversion
tool
that includes markings thereon to allow a person evening the graft to achieve
a desired oblique
angle in an anastomosis by using a graft evened using the marked tool.
An aspect of some embodiments of the invention relates to a split delivery
system, in
which the delivery system is split after the anastomosis is completed, to
remove the system
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from the graft. In an exemplary embodiment of the invention, a line on which
the system is
split is not straight. In particular, the split line meanders so that, at a
point where the graft is
inserted into the delivery system, the split line will not lie along a line
between the graft artd
the system tip. Thus, the vessel is less likely to catch on the split line.
An aspect of some embodiments of the invention relates to a two part
anastomotic
connector in which the connector defines a ring around the outside of the
anastomosis location.
In an exemplary embodiment of the invention, this ring is used to guide a
desirable distortion
of a vessel tip of at least one of the attached vessels. In an exemplary
embodiment of the
invention, the ring is defined by a part of the device mounted on a side
vessel of an end-to-side
connection. A potential advantage of the two part device is that the locking
mechanism is thin,
so the profile of the device can be low. Another potential advantage is that
the distortion of the
vessel forms a thickening and/or eversion, so that a better seal may be
achieved.
There is also provided in accordance with an exemplary embodiment of the
invention,
a method of preparing a graft for an anastomosis, comprising:
providing a graft having a lip at an opening therein; and
compressing said lip of said graft to form at least one thickened portion
adjacent said
opening. Optionally, said thickening is uniform around said opening.
Alternatively, said
thickening is non-uniform around said opening. Optionally, said thickening is
non-uniform in
length. Alternatively or additionally, said thickening is non-uniform in
thickness.
In an exemplary embodiment of the invention, said thickening is selected to
achieve a
desired pre-stressing of said graft for an oblique anastomotic connection.
Alternatively or
additionally, said thickening is selected to achieve a match between the lips
of two vessels.
Alternatively or additionally, said thickening is selected to achieve a size
match between the
lip of the graft and the lip of an opening in a target vessel. Alternatively
or additionally, said
thickening is selected to achieve a minimum size of seal area between the lip
of the graft and
the lip of an opening in a target vessel.
In an exemplary embodiment of the invention, the method comprises transfixing
said
thickening with at least one spike.
In an exemplary embodiment of the invention, said spike is axially disposed
with
respect to said graft. Alternatively, said spike is obliquely disposed with
respect to said graft.
In an exemplary embodiment of the invention, said thickening is maintained in
shape
by a connector.
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In an exemplary embodiment of the invention, compressing said lip comprises
compressing using an anastomotic connector. Alternatively or additionally,
compressing said
lip comprises compressing using a graft compression tool.
In an exemplary embodiment of the invention, compressing said lip comprises
evening
an intima of said graft at least 90°. Alternatively or additionally,
compressing said lip
comprises evening an intima of said graft at least 120°. Alternatively
or additionally,
compressing said lip comprises evening an intima of said graft at least
160°.
In an exemplary embodiment of the invention, said evening matches said intima
to an
intima of a target vessel.
In an exemplary embodiment of the invention, said opening is an opening in
side of
said graft. Alternatively, said opening is an opening in an end of said graft.
In an exemplary embodiment of the invention, said graft is a blood vessel.
Optionally,
said graft is a mammary artery.
In an exemplary embodiment of the invention, said graft is a synthetic graft.
In an exemplary embodiment of the invention, the method comprises attaching
said
graft to a blood vessel. Alternatively or additionally, the method comprises
attaching said graft
to a synthetic graft.
There is also provided in accordance with an exemplary embodiment of the
invention,
a connector adapter to be distorted for oblique connections, comprising:
a plurality of interconnected segments, at least some of said segments
including a
forward spike or a backward spike; and
a plurality of distortable portions defined between said segments, wherein
said portions
are adapted to support a distortion from a straight anastomosis to an oblique
anastomosis.
Optionally, said distortable portions comprise at least one ring.
Alternatively or additionally,
are designated in a ring that interconnects said segments.
In an exemplary embodiment of the invention, said distortable portions are
annealed.
In an exemplary embodiment of the invention, said spikes are self extending.
Alternatively, said distortable portions are plastically deformable.
In an exemplary embodiment of the invention, said distortable portions are pre-
stressed
to mach an oblique connection configuration. Alternatively or additionally,
said distortable
portions are unevenly distributed on said connector. Optionally, said
distribution matches an
expected amount of distortion at the different pans of said connector.
There is also provided in accordance with an exemplary embodiment of the
invention,
a method of creating an oblique eversion in a graft, comprising:
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evening a graft to have a straight evened sleeve; and
differentially extending one side of the sleeve, to form an oblique eversion.
Optionally,
said evening comprises evening over a connector having spikes. Optionally,
said spikes are
fully extended during said evening. Optionally, said method comprises
assisting said spikes to
penetrate said sleeve after said differentially extending.
In an exemplary embodiment of the invention, said spikes are partially
extended during
said evening. Optionally, the method comprises fully extending said spikes to
penetrate said
sleeve.
In an exemplary embodiment of the invention, said spikes are not extended
during said
evening. Alternatively or additionally, differentially extending comprises
extending only pan
of said sleeve. Alternatively, differentially extending comprises extending
all of said sleeve.
Alternatively, differentially extending comprises manually pulling down said
side using
tweezers.
In an exemplary embodiment of the invention, differentially extending
comprises
pulling down said side using a pad that slides along said graft, which pad
includes a vessel
engaging element to engage said side. Alternatively, differentially extending
comprises pulling
down said side using a tube that slides along said graft, which tube includes
a vessel engaging
element to engage said side. Optionally, said tube comprises at least a second
vessel engaging
element, to engage an opposite side of said sleeve. Alternatively or
additionally, said tube is
capped, to prevent over sliding of said tube over said graft.
There is also provided in accordance with an exemplary embodiment of the
invention,
a method of creating an oblique eversion in a graft, comprising:
mounting said graft inside a graft holder having a slotted axial extension;
mounting a connector on said graft such that a spike of said connector exits
through
said slot; and
everting said graft on said tube, such that a portion everted over said
extension is
longer than a portion evened not over said extension.
There is also provided in accordance with an exemplary embodiment of the
invention,
a method of penetrating non-perpendicular pointing spikes of a connector into
an evened graft,
comprising:
radially compressing said spikes;
evening said graft over said connector; and
suddenly releasing said spikes, to penetrate said graft. Optionally, said
radially
compressing aligns said spikes to be more perpendicular to said graft.
Alternatively, radially
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compressing comprises restraining said spikes using a slotted tube and wherein
suddenly
releasing comprises rotating said tube so that said spikes align with and pass
through said
slots. Optionally, all of said spikes are aligned simultaneously with said
slots by said rotation.
Alternatively, not all of said spikes are aligned simultaneously with said
slots by said rotation.
In an exemplary embodiment of the invention, radially compressing comprises
restraining said spikes using an over-tube and wherein suddenly releasing
comprises retracting
said tube relative to said spikes so that said spikes are released.
Optionally, said over-tube
comprises a graft holder for said graft. Alternatively, said over-tube is
separate from a graft
holder for said graft.
In an exemplary embodiment of the invention, retracting said tube relative to
said
spikes comprises advancing said connector.
In an exemplary embodiment of the invention, retracting said tube relative to
said
spikes comprises retracting said over-tube.
In an exemplary embodiment of the invention, said spikes are partially
extended so
they can contact said graft, prior to said suddenly releasing.
In an exemplary embodiment of the invention, said spikes are not all the same
length,
so that when released they do not all penetrate said graft at a same time.
In an exemplary embodiment of the invention, said tube is oblique.
In an exemplary embodiment of the invention, radially compressing comprises
restraining said spikes using a looped thread. Optionally, said looped thread
comprises a
slipknot.
There is also provided in accordance with an exemplary embodiment of the
invention,
a method of penetrating non-perpendicular pointing spikes of a connector into
an evened graft,
comprising:
evening said graft over said connector;
placing a cap on said evened graft; and
manipulating said cap to cause penetration of said spikes into said graft.
Optionally,
manipulating comprises rotating said cap. Alternatively or additionally,
manipulating
comprises axially displacing said cap.
There is also provided in accordance with an exemplary embodiment of the
invention,
a method of evening a graft, comprising:
mounting said graft in a graft holding tube;
providing a conical membrane inside a lumen of said graft; and
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evening said membrane to effect an eversion of said graft. Optionally, said
conical
membrane comprises a relatively rigid base ring. Alternatively or
additionally, said conical
membrane comprises a relatively rigid extension from its tip.
In an exemplary embodiment of the invention, said evening comprises obliquely
evening said conical membrane.
There is also provided in accordance with an exemplary embodiment of the
invention,
a split graft holder, comprising:
a tube having a tip for the exit of a graft, defining:
a side opening for receiving the graft through a lumen of said tube to said
tip;
and
a split line along said tube axis and meeting said side opening, for splitting
said
holder to remove said holder from a graft, after said graft is attached to
another blood conduit,
wherein
said split line does not axially meet said side opening, at a side of said
opening near
said tip of said tube. Optionally, said split line meets said opening from its
side.
There is also provided in accordance with an exemplary embodiment of the
invention,
a reducing profile anastomotic connector, comprising:
a ring section;
a spikes section comprises a plurality of spikes, wherein said spikes section
defines a
collapsing portion, for axial collapsing of said spikes section. Optionally,
said collapsing
portion buckles. Alternatively or additionally, said collapsing portion
twists. Alternatively or
additionally, said collapsing portion folds out.
In an exemplary embodiment of the invention, said collapsing portion self
deforms.
Alternatively, said collapsing portion plastically deforms.
There is also provided in accordance with an exemplary embodiment of the
invention,
a combined hole punching and graft delivery device, comprising:
a body, having therein at least one recess for receiving a spike of a
connector; and
a sharp tip retractable relative to said body, wherein said sharp tip and said
body define
between them a blood vessel wall receiving area. Optionally, said recess
includes a protrusion,
for selectively releasing said spike when said body is rotated relative to
said spike.
Alternatively or additionally, said spike is pre-stressed to self extend out
of said recess.
Alternatively, said spike radially extends out of said recess when it is
retracted.
There is also provided in accordance with an exemplary embodiment of the
invention,
a graft evening tool, comprising:
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a base ring;
an extension adapted to be inserted in a graft; and
a conical membrane-like element connecting said base and said extension, and
adapted
to engage an inside of a blood vessel.
wherein said membrane is flexible enough to be evened. Optionally, said tool
is
adapted to even obliquely. Alternatively or additionally, said tool has a non-
uniform graft
property, so as to effect an oblique eversion when it is used to even a graft.
There is also provided in accordance with an exemplary embodiment of the
invention,
a tool for compressing a tip of a graft, comprising:
an outer mandrel mounted over the graft and reaching to about an opening in
the graft;
an inner mandrel mounted inside the graft and reaching to about said opening;
and
a base,
wherein said base and said rivo mandrel define a space for said graft to
extend into
when the mandrels are brought together. Optionally, said inner mandrel is
mounted on said
base. Alternatively or additionally, said inner mandrel is expandable.
Alternatively or
additionally, said inner mandrel is adapted to engage at least a portion of
said graft.
Alternatively or additionally, said outer mandrel is adapted to engage at
least a portion of said
graft.
There is also provided in accordance with an exemplary embodiment of the
invention,
a tool for forming an oblique eversion from a graft evened over a graft
holder, comprising:
a body shaped to slide over said evened graft; and
at least one graft engaging element for selectively engaging only one side of
said
evened graft. Optionally, said body comprises a tube. Alternatively, said body
comprises a
tube segment.
In an exemplary embodiment of the invention, said body is capped to prevent
axial
motion beyond a certain amount.
In an exemplary embodiment of the invention, the tool comprises at least a
second graft
engaging element for engaging a second side of said evened graft.
There is also provided in accordance with an exemplary embodiment of the
invention,
a tool for forming an oblique eversion for a graft, comprising:
a tube; and
at least one axial extension of said tube, such that a spiked connector
disposed in said
tube can project at least one of its spikes near a base of said projection.
Optionally, said at least
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one projection comprises at least two projections defining a slot between
them, with said spike
extending through said slot.
There is also provided in accordance with an exemplary embodiment of the
invention,
a tool for forming an oblique eversion for a graft, comprising:
a tube adapted for having a graft and a connector mounted therein; and
an over-tube which radially restrains at least one spike of said connector,
wherein said
connector can be moved relative to said over-tube. Optionally, said over tube
is slotted and
wherein said motion is rotation. Alternatively or additionally, said motion
comprises axial
motion of said connector relative to said over-tube. Alternatively or
additionally, said tube is a
same element as said over tube.
In an exemplary embodiment of the invention, said over-tube is oblique.
There is also provided in accordance with an exemplary embodiment of the
invention,
a tool for assisting spike penetration into an evened graft; comprising:
a graft and connector holder having a graft evened thereon; and
a cap having an inner diameter larger than an outer diameter of said graft and
connector
holder, for mounting on said evening graft.
There is also provided in accordance with an exemplary embodiment of the
invention,
a tool for assisting spike penetration into an evened graft; comprising:
a handle, defining at least two arms; and
a wire between said two arms,
wherein said tool is adapted for assisting penetration of a spike into an
evened graft.
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
pans 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 show an evened graft and grafts with simulated eversion, in
accordance
with exemplary embodiments of the invention;
Figs. 2A-2C illustrate various anastomotic connections using thickened grafts,
in
accordance with exemplary embodiments of the invention;
Figs. 2D and 2E illustrate the use of graft distortion to vary the graft
layout, in
accordance with an exemplary embodiment of the invention;
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Fig. 3 illustrates a blood vessel distorter, in accordance with an exemplary
embodiment
of the invention;
Figs. 4A and 4B illustrate a distortable connector, in straight and distorted
configurations, in accordance with an exemplary embodiment of the invention;
Figs. 4C and 4D are side cross-sectional views of an anastomotic connection
utilizing
the connector of figs. 4A and 4B, before and after relaxation of strain;
Figs. SA-SE illustrate a two part connector and a method of deploying such a
connector, in accordance with an exemplary embodiment of the invention;
Figs. 6A-6E illustrate methods and apparatus for reducing an axial profile of
an
anastomotic device, in accordance with exemplary embodiments of the invention;
Figs. 7A and 7B illustrate the working of a flexible graft everter, in
accordance with an
exemplary embodiment of the invention;
Figs. 8A-8D illustrate a lasso-based release mechanism, in accordance with an
exemplary embodiment of the invention;
Figs. 8E-8F show two different lasso configurations for use with the
embodiments
shown in Figs. 8A-8D;
Figs. 9A-9D illustrate a slotted-tube mechanism for sudden release of spikes
of a
connector;
Fig. 10A and lOB illustrate an over-tube based spike penetration method and
apparatus, in accordance with an exemplary embodiment of the invention;
Figs. 11A-11C illustrate a cap based technique and apparatus for spike
penetration, in
accordance with an exemplary embodiment of the invention;
Figs. 12A-12C illustrate a probe and a spike penetration method using the
probe, in
accordance with an exemplary embodiment of the invention;
Figs. 13A and 13B illustrate a tool for oblique eversion, in accordance with
an
exemplary embodiment of the invention;
Figs. 14A and 14B illustrate a method of converting an even eversion into an
oblique
eversion, in accordance with an exemplary embodiment of the invention;
Figs. 15A-15C illustrate an alternative method of converting an even eversion
into an
oblique eversion, in accordance with an exemplary embodiment of the invention;
Figs. 16A and 16B illustrate a cap-like tool for converting a perpendicular
eversion
into an oblique eversion, in accordance with an exemplary embodiment of the
invention;
Fig. 17 illustrates an exemplary combined hole punch and connector inserter
tool, in
accordance with an exemplary embodiment of the invention; and
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Figs. 18A and 18B illustrate a graft delivery system, in accordance with an
exemplary
embodiment of the invention.
DETAILED DESCRIPTION OF EYEMPLARY EMBODIMENTS
Some embodiments of the invention utilize the fact that the vascular tissue
has non-
trivial mechanical properties. In an exemplary embodiment of the invention,
the ends of a graft
vessel are compressed, to achieve various effects, for example, pre-stressing
the graft to be
inclined to a certain post-anastomotic shape, thickening the graft to support
transfixing of the
graft, at non-perpendicular angles, using spikes of a connector and/or
presenting an intima to
an anastomosis connection, without a complete eversion of the graft. It is
noted that thickening
the ends of the graft may also improve the leakage-prevention properties of
the anastomotic
connection. In some embodiments of the invention, a graft having the desired
thickening
and/or distortion is manufactured.
Figs. 1 A-1 D show an evened graft and grafts with simulated eversion, in
accordance
with exemplary embodiments of the invention. Fig. 1A shows a standard evened
vessel 100,
having evened lips 102.
Fig. 1B shows vessel 100 with its end compressed, so that a thickened portion
104 is
formed at the distal end of the graft. This thickening may, for example, match
a greater vessel
thickness of a target vessel and/or provide for a better seal.
Fig. 1 C shows vessel 100 with its end unevenly compressed, so that thickened
portions
106 and 108 are of different lengths. The end-face of the vessel is
perpendicular to the vessel
axis. In an exemplary embodiment of the invention, this type of distortion pre-
stresses the
graft, so that when the anastomosis is completed, the graft will naturally
curve in a desired
connection, for an oblique connection or for a perpendicular connection with a
curving graft. It
is expected that thus pre-stressing may, in some cases, reduce a tendency to
kink.
Fig. 1D shows an alternative uneven thickening, in which thickened ends 110
and 112
define an oblique end face for vessel 100. An oblique connector 114 is shown
mounted on
vessel 100. Connector 114 comprises, for example, a ring 116 and a set of
longer spikes 118
that transfix the longer thickened portion 110 and a set of shorter spikes 120
that transfix the
shorter thickened portion 112. As can be seen, the anastomotic connector may
be material in
maintaining the axially compressed condition of the vessel end, however, this
is not required.
In Figs. 1C and 1D, the graft way be originally cut with at an angle, or not.
The thickening may be, for example, a multiple of the original graft wall, for
example,
a factor of 1.1, 1.~. 2.0, 2.5, 3.0 or any greater, smaller or intermediate
number. Alternatively
or additionally, it may be absolute, for example, 0.5 mm, 1 mm, 1.~ mm or 2
mm, or any
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greater, smaller or intermediate size. The length of the thickening may vary,
for example,
being 0.3 mm, 0.6 mm, I mm, 2 mm, 4 mm or any greater, smaller or intermediate
size.
Alternatively or additionally, the length is a function of the graft diameter,
for example, being
a factor of 0.3, 0.5, 1, I.5 or any greater, smaller or intermediate number.
The angle (possibly
measured at a short distance from the anastomosis location) of an oblique
connection may he,
for example, 10°, 20°, 30°, SO°, 70°,
80° or any greater, smaller or intermediate angle. In some
cases, the angle is with the flow direction, in others, perpendicular or
against the flow
direction.
Figs. 2A-2C illustrate various anastomotic connections using thickened grafts,
in
0 accordance with exemplary embodiments of the invention. In these figures,
the graft is vessel
200 and the target vessel is either an end vessel 202 or a side vessel 204. In
an exemplary
embodiment of the invention, side vessel 204 is an aorta or other thick
artery, which has a
thick wall and may be difficult to invert. Alternatively, it may be a graft or
a stmt graft.
Fig. 2A shows two exemplary end-to-end anastomosis connections, 206 and 208.
In
anastomosis 206, the tips of the vessels are thickened, thereby possibly
affording a better seal
and/or compensating for any unevenness in the vessels. In anastomosis 208, the
marked area
indicates the intima of the vessels. As shown, one or both vessels are
distorted so that their
intimas meet, even though the vessels are not completely evened. Such
distortion can be
achieved, for example, by pulling back the outer side of the thickened
portion, pulling along
the intima portion. Alternatively, the vessels may be distorted so that the
outside of the vessels
meet, for example by stretching the outside of the vessels, rather than the
intima.
Fig. 2B shows two exemplary end-to-side anastomosis connections, 210 and 212.
In
connection 210, the lip of side vessel 204 is partially evened. Alternatively,
it may be axially
compressed, to make it thicker. In connection 212, the vessel lip is not
modified, and the
thickening of the tip of vessel 200 may afford a better seal. The intima of
vessel 200 may or
may not be exposed, as shown in Fig. 2A.
Fig. 2C shows two additional exemplary end-to-side anastomosis connections,
214 and
216. In connection 214, the end of vessel 200 is thickened and distorted to
have a non-uniform
face, so that an extension of vessel 200 enters side vessel 204. Possibly,
some or all of the
extension exposes an intima, as shown in the Fig. Optionally, as shown, a
thickening of vessel
200 remains outside vessel 204 and in contact with its outer surface, for
example for providing
a better seal and/or a more stable seal. In connection 216, the lip of side
vessel 204 is partially
everted, to contact its intima with vessel 200.
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As shown in Fig. 2C, the front face of vessel 200 need not be planar, and can
vary. In
addition, the side profile of the thickened part can vary, for example to
include a bump that
abuts against the walls of the opening in the side vessel, possibly providing
a sealing ring.
Alternatively, similar distortions may be used for side-to side connections,
or for hole
closures (both lips from same blood vessel). In such connections, intima-to-
intima meeting
may be desirable, alternatively or additionally to matching up of vessel lips
over a large area.
In an exemplary embodiment of the invention, an anastomosis connector is
converted into a
hole closure device by providing a membrane (e.g., part of a graft) across the
lumen of the
connector.
The various contact configurations and vessel distortions shown in Figs. 2A-2C
may be
maintained using a variety of methods, for example, sutures, tissue adhesive,
connectors that
transfix the distorted portion with a spike and/or connectors that apply a
constraining force on
the distorted portion.
It should be noted that distortion of a vessel may be easier to achieve than
eversion, for
example if the vessel is fragile or calcified or if the tip of the vessel is
in a hard to reach area.
Figs. 2D and 2E illustrate the use of graft distortion to vary the graft
layout, in
accordance with an exemplary embodiment of the invention. In Fig. 2D, a graft
is bent by
thickening only one side of the graft (or differentially thickening two sides)
to form a
thickening 222 are a bending location thereof. The thickening may be
maintained, for example,
by a pin or staple 224. In Fig. 2E, a graft is shortened, by forming
thickenings 228 at its center,
optionally holding them together using a pin 230. In some cases, the selective
distortion of
grafts is practiced after the anastomosis is completed, to assure that the
graft will not kink or
otherwise lay in an undesirable configuration.
The distorted grafts and/or vessels may be of any type, for example synthetic,
xenologous, autologus (e.g., veins and arteries), and cadaver tissue. However,
the LIMA and
RIMA mammary arteries appear to have significant potential for distortion.
Other exemplary
suitable target vessels include the radial and gastro-epiploic arteries. It
should be noted that the
methods described herein can be applied to a vessel that is connected at one
or both ends to the
body, or to a vessel that is not connected to the body. The vessel may be
inside the body, for
example being connected or being provided through a tube, for example
endocscopically or
transvascularly. Alternatively, at least a part of the vessel that is worked
on outside the body.
Fig. 3 illustrates an exemplary blood vessel distorter 300, in accordance with
an
exemplary embodiment of the invention. A vessel 302 is mounted on an inner
tubular support
14
CA 02393508 2002-06-03
WC~ 01141623 PCT/IL00/00609
304. An outer tube 306 engages vessel 302 at least at an engagement portion
308. At the base
of tube 312 there is defined a moat 315 by a surrounding wall 312 and a base
element 313.
When tube 306 is advanced, it pushes vessel 302 into the moat, where unduly
radial
expansion is prevented by wall 312. If tube 306 is slightly shy from the
vessel edges, as
shown, the vessel end will distort to the form shown as a dotted line by
reference 314. In an
exemplary embodiment of the invention, tube 306 engages vessel 302 by
providing an over
tube 310 that radially compress tube 306, or at least engaging portion 308
thereof.
In an alternatively embodiment of the invention, vessel 302 is held by tube
304, for
example by forcing a widening wedge 316 into a lumen of tube 304.
The outer surface of tube 304 and the inner surface of tube 306 may be smooth
or it
may be rough, at least at some locations. By suitable selection of rough
locations and the tube
that engages vessel 302, various effects can be achieved. In one example,
engaging vessel 302
via its inner surface, prevents motion of the intima. In another example,
after the vessel is
compressed, tube 304 is expanded to hold the intima and tube 306 is slightly
retracted, causing
the intima to be exposed at the front or outside of vessel 302.
A connector may be mounted on the compressed vessel in various manners. In one
example, the connector sits inside moat 315. In another example, the connector
is between
tubes 304 and 306. Possibly, portion 308 is axially slotted, to receive spikes
of the connector.
Alternatively or additionally, the connector is mounted in a recess in portion
308. Alternatively
or additionally, base 313 and/or tube 306 are slotted, to accommodate the
connector. It should
be noted that tubes 304 and 306 can have a non-circular cross-section, for
example, elliptical
or polygonal cross-sections. In some embodiments of the invention, the
distortion includes
twisting of vessel 302. In some embodiments, this twisting will be assisted by
a spiral pattern
on tube 304 and/or tube 306. Further, base 313 may not be flat, for example to
assist in
achieving the distortions shown in Fig. 2C.
The distorted blood vessel may be distorted plastically, elastically or a
combination of
elastic and plastic distortion. The vessel may be cooled, to prevent it from
returning to the
undistorted configuration
When compressing the lips of a side opening, the inner tube may have the form
of a T-
shaped mandrel, for example, and the outer tube may be slotted, to receive the
graft.
Referring back to Fig. 1 C, when the graft is released, for example after an
anastomosis
is completed, the graft will tend to assume a non-perpendicular orientation to
a side vessel to
which it is attached. This is also the case where a graft is evened in a non-
even manner. The
CA 02393508 2002-06-03
WO 01/41623 PCT/IL00/00609
strain caused by the uneven eversion or the uneven compression will tend to
curve the graft.
Such curvature may be desirable in an anastomotic connection.
If the anastomotic connector has a low enough profile (e.g., protrusion from
the inner
surface of the target vessel), the curving of the graft can proceed without
the connector itself
affecting the cun~e. Alternatively, the connector itself may be oblique.
In an alternative embodiment of the invention, a connector that is naturally
distortable
into an oblique configuration, is provided. Such a connector supports an
oblique connection.
Possibly, the connector may be pre-stressed into a distorted configuration.
Alternatively or
additionally, the connector may be distorted by strain release in the graft.
Alternatively or
additionally, the connector may be manually distorted after the anastomosis is
completed.
Figs. 4A and 4B illustrate a side of a distortable connector 400, in straight
and in
distorted configurations, in accordance with an exemplary embodiment of the
invention.
Connector 400 comprises a plurality of forward spikes 404 and a plurality of
backward spikes
402. The sets of spikes are interconnected using a ring 408 that includes
distortable sections
406. In an exemplary embodiment of the invention, sections 406 are designed to
act as hinges.
Alternatively or additionally, sections 406 distort in a manner which allows
them to return to a
pre-stressed shape, for example by being elastic, super-elastic or shape-
memory pre-stressed.
Alternatively, sections 406 are plastically deformable. The distribution of
sections 406 may be
uniform or non-uniform, for example being greater at ring areas where a
greater distortion is
required (as shown). This general design (providing distortion sections) may
be applied to
other anastomotic connectors, for example, to annular ring connectors (on the
ring itself two-
part connectors (on one or both parts) or to connectors with multiple axial
rings or cell
elements (at spaced apart radial locations).
Connector 400 may be pre-stressed to the configuration shown in Fig. 4B,
however, it
is deployed as shown in Fig. 4A, for example using an axial restraining
element (e.g., a slotted
over-tube), that limits the axial position of the ring 408.
In an exemplary embodiment of the invention, pairs of distortable sections 406
are
provided on axially pointing sections of ring 408, so that axial distortion
can be achieved by
non-axial motion of the axial sections between distortable sections 406.
Figs. 4C and 4D are side cross-sectional views of an anastomotic connection
utilizing
connector 400, before and after relaxation of strain. In Fig. 4C, the
anastomosis is just
completed, for example, using a perpendicular hole-punch and a perpendicular
delivery
system. A tube 410 may be provided to maintain this perpendicular orientation.
Tube 410 may
be a same tube that is used as a graft holder for providing the vessel and the
connector to the
16
CA 02393508 2002-06-03
WO 01/41623 PCT/IL00/00609
anastomosis connection. When tube 410 is removed (e.g., for self deforming or
graft based-
deforming embodiments), or if holder 410 is rotated on its end (e.g., for
plastic embodiments)
the connection distorts and assumes the oblique configuration shown in Fig.
4D. The shape of
the lumen may remain circular or it may also distort, for example into an
ellipse.
In some embodiments of the invention, the distortion of connector 400 also
involves
radial expansion, for example, in a self deforming connector, thereby sealing
the anastomotic
connection. Alternatively, the device may elastically expand radially, while
being plastically
distorted, for example by selective annealing of sections 406, for example
using a contact
heater, or an energy beam.
In some embodiments of the invention, the connector itself may perform the
eversion
and/or other distortion of the graft.
Figs. SA-SE illustrate a two part connector and a method of deploying such a
connector, in accordance with an exemplary embodiment of the invention. Fig.
5A shows a
configuration 500 including two parts, an end configuration 502 and a side
configuration 504.
End configuration 502 includes a graft 506 having a first connector part 508
mounted
thereon. As shown, connector 508 includes a plurality of spikes 510 that
penetrate graft 506.
The spikes may be interconnected by a ring S 14 and include a locking
mechanism 512.
Optionally, an intra-wall spike 509 is provided to guide the distortion of the
tip of graft 506.
Connector 508 is held by an outer holder 516 and optionally abuts against a
pusher 518.
Side configuration 504 comprises a side vessel 530 having mounted thereon a
second
connector part 520. Connector part 520 comprises a plurality of spikes 522
that pierce vessel
530, optionally attached to a ring 524. A locking mechanism 526 may be
provided, which
optionally mates with locking mechanism ~ 12 of part 508. An outer holder 528
is provided
outside of part 520. In some embodiments of the invention, holders 528 and 516
provide
radially rigidity to the connector during the deployment process and may
possibly replace the
use of ring like elements (S 14, 524) in one or both connector parts.
In Fig. 5B, configuration 502 is being inserted into configuration 504.
Possibly, holder
506 snugly fits into holder 528. Optionally, the two holders are slotted, to
enforce certain
relative rotational positions of the connectors, for example for oblique
connections. Possibly,
holder 528 and/or holder S 16 include an inner thread, to support twisting of
holder 516, while
it is advanced.
In Fig. ~C, holder 516 is locked into position relative to holder 528.
Attention should
be taken of a volume X32 defined between connector parts 508 and X20. It
should be noted that
graft X06 and graft X30 are prevented from expansion into the anastomosis
lumen, by spikes
17
CA 02393508 2002-06-03
WO 01/41623 PCT/IL00/0060G
522 and 510. However, expansion towards holder 528 is possible, due to a
difference in
radiuses between the two connector parts. In some embodiments, eversion is
achieved instead
of distortion.
In Fig. SD, pusher 518 is advanced, possibly in a spiral motion, first
compressing the
very end of graft 506 and then completing the anastomosis by the interlocking
of locking
elements 512 and 526. In an exemplary embodiment of the invention, the locking
elements
comprises a tab punched out of a metal sheet in one element and a matching
slot for the tab in
the other element.
In Fig. SE, the holders are removed, leaving a completed anastomosis
connection. In an
exemplary embodiment of the invention, the parts of the connector that remain
in the blood
flow are thin wires, for example metal or plastic.
In an exemplary embodiment of the invention, side configuration 504 is
inserted with
spikes 522 in a straight configuration. The spikes may be pre-stressed to be
bent, and
prevented from bending by bars that are later retracted. Alternatively, spikes
522 are
plastically bent, for example using an anvil provide through the hole in
vessel 530 (not
shown). Punching out of the hole may, in some embodiments of the invention, be
performed
after the spikes are inserted.
Although the connectors of Figs. 5A-SE are shown for an end-to-side
connection, it
should be appreciated that a similar device may be used for an end-to-end
connection and/or a
end-to-side connection. In such connections, as well as a side-to-end
connection, the lips of
one or both vessel may be distorted.
Figs. 6A-6E illustrate methods of reducing an axial profile of an anastomotic
device, in
accordance with exemplary embodiments of the invention. These illustrations
are shown on a
simple two part anastomotic device. However, they may be applied to other two
part devices
or to one part devices that include ring and spike portions, for example as
shown in the above
referenced PCT applications.
Fig. 6A illustrates a two part anastomotic connector 600 comprising a ring
portion 602,
for mounting outside an "end" vessel and a spike portion 604 for penetrating a
side vessel
and/or an everted portion of the end vessel. In this and other embodiments,
the ring portion
and the spike portion may be integral, or may be separate parts, for example
slots or openings
formed in the ring portion, for the spike portion. An extension 606 of spike
portion 604 may
be used, for example, for holding, pushing and/or pulling spike portion 604.
Once the
connection is completed, extension 606 is bent outwards, as shown, to reduce
the axial profile
of the anastomotic connection. Such bending may also server to lock the
anastomotic
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CA 02393508 2002-06-03
WO 01/41623 PCT/IL00/00609
connection. Such bending can be achieved, for example, by advancing an over-
tube that has an
inclined front edge, over the side vessel. The smallest diameter of the over-
tube fits between
extension 606 and the vessel. However, the larger diameter is significantly
greater, causing
extension 606 to be bent. Alternatively, extension 606 may be twisted in place
and/or sniped
off.
Figs. 6B and 6C illustrate a twist based profile reduction method. A connector
610
comprises a ring 612 and a spike portion comprising a set of spikes 613 also
connected to a
ring 614. An extension 618 of the spikes portion protrudes above ring 612. In
Fig. 6C,
extension 618 has been axially retracted to a degree sufficient for performing
the anastomosis,
for example by bringing a vessel engaged by the spikes into contact with a
graft everted on the
spikes and/or ring. Extension 618 is then twisted, thereby reducing the axial
extent of
extension 618 and/or locking the anastomotic connection.
Figs. 6D and 6E illustrate a bending based profile reduction method. A
connector 620
comprises a ring 622 and a spike 624, of which an extension 626 protrudes
above the ring 622.
In Fig. 6D, after the anastomosis is completed, extension 626 is advanced, so
that it buckles,
reducing its axial extent. In an exemplary embodiment of the invention, ring
622 is axially
rotated twisted relative to spikes 624. Such rotation is useful if the slots
in ring 622, through
which spikes 624 fit, have a wedge profile. The rotation, urges the spikes
into the narrower
part of the wedge, to be snugly engaged by the ring, so that the advancing of
extension 626
does not cause the post-ring parts of spikes 624 to advance.
Although the spikes portions in the above embodiments of Fig. 6 may be
plastically
deformed, in an alternative embodiment of the invention, the spikes are
elastic, super-elastic or
shape-memory materials, which self deform when a restraint (not shown) is
released.
Figs. 7A and 7B illustrate the working of a flexible graft everter 706 in
accordance
with an exemplary embodiment of the invention. A graft 702 is mounted inside a
holding tube
704, which may also be used for providing a connector (not shown). Everter 706
is inserted
into the lumen of graft 702. In an exemplary embodiment of the invention,
everter 706
comprises an extension 708, that fits into graft 702, a flexible portion 710
and a relatively rigid
ring portion 712. Everter 706 may have the general form of a cone or a condom,
for example
as shown. In an exemplary embodiment of the invention, the outer surface of
everter 706 may
be rough or barbed, to better engage the inner surface of graft 702. In some
cases, the
membrane is not continuous, for example comprising a plurality of flexible
rods connecting
ring 712 and extension 708, or the membranes having apertures formed therein.
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In operation, as shown in Fig. 7B, ring portion 712 is advanced towards graft
702,
causing membrane 710 to fold, carrying graft 702 along with it, to be everted.
In some
embodiments of the invention, membrane 710 is designed to effect an oblique
eversion, for
example, by membrane 710 having a non-radially uniform flexibility, so that it
does not even
uniformly. Alternatively or additionally, different parts of membrane 710 have
different
friction coefficients with the grafts so that some parts pull the graft more
when the membrane
is evened. Alternatively or additionally, holding tube 704 is oblique.
In some embodiments of the invention, instead of evening the graft, the graft
is
provided with an intima on its outside or front surfaces, for example,
patterned to match a
particular anastomosis connection configuration. In an exemplary embodiment of
the
invention, the graft is manufactured to include the intima. Alternatively or
additionally, a layer
of intima, for example an inverted graft section or a vessel flap is glued on
the graft. It is noted
that an inner surface of the tip of the graft may be manufactured to not
include an intima, for
example to facilitate attachment to an outside surface of a blood vessel.
The graft may be evened directly onto the spikes of the anastomotic connector.
However, this may not be easy to do. For example, the spikes may point
sideways or even
backwards, rather than forwards. Alternatively or additionally, the graft may
be tough enough
to resist penetration by self expanding spikes or to bend spikes that are
advanced relative to
the graft.
Figs. 8-10 illustrate three sudden-release mechanisms by which the spikes can
be
restrained and then released suddenly, to penetrate the graft.
Figs. 8A-8D illustrate a lasso-based release mechanism, in accordance with an
exemplary embodiment of the invention. In Fig. 8A, a graft 802 is inserted
through a graft
holder 804 having mounted thereon a connector 806 with backwards pointing
spikes 808. In
Fig. 8B, a lasso 810 having a loop 812 is tied on spikes 808, bending them
radially inwards, so
that the spikes point substantially forward. Graft 802 is then everted over
the lassoed
connector, for example using the method shown in Fig. 7A and 7B, or using any
other method.
In Fig. 8C, lasso 810 is released allowing spikes 808 to spring out and
penetrate graft 802. In
Fig. 8D, spikes 808 have completed their penetration, possibly with some
manual assistance
(for example as described below), and the mounting is completed.
Figs. SE-8F show two different lasso configurations for use with in Figs. 8A-
8D. In
Fig. 8E, lasso 810 includes only a single loop 812. In Fig. 8F, the lasso
includes multiple
loops. Both lassoes, however, can be released by pulling on the thread.
Possibly, the lassoes
are formed of a surgical suture material or of a thin Dacron filament.
CA 02393508 2002-06-03
wo onai6z~ rcTm,ooioo6o9
Figs. 9A-9D illustrate a slotted-tube mechanism 900 for sudden release of
spikes of a
connector.
Fig. 9A shows a graft 902 mounted in a graft holder 904, along with a
connector 906
having backward bending spikes 908. A slotted over-tube 910 is provided.
Optionally, over-
tube 910 includes a shield 912 (described below).
In Fig. 9B, over-tube 910 is advanced, so that spikes 908 are bent back and
held in a
step resting place 914. In addition, shield 912 prevents spikes 908 from
contacting graft 902,
once it is evened. The graft may then be evened over over-tube 910.
In Fig. 9C over-tube 910 is rotated, so that spikes 908 are aligned with slots
916
formed in over-tube 910, causing the spikes to exit over-tube 910 and
penetrate the evened
graft 902.
Fig. 9D is a top view of over-tube 910 showing slots 916, shield 912 and step-
resting
place 914 for spikes 908.
Although only two spikes are shown in the figure, a real connector may include
greater
number of spikes, for example, 4, 6, 8 or more.
Fig. 10A and lOB illustrate an over-tube based spike penetration method, in
accordance with an exemplary embodiment of the invention. Fig. 10A shows a
configuration
1000, in which a graft 1002 is shown mounted on a graft holder 1004 and evened
over an
over-tube 1010. A connector 1006 including backward pointing spikes 1008, is
separated from
an evened portion of graft 1002, by over-tube 1010, which over-tube also bends
back spikes
1008.
In Fig. 10B, over-tube 1010 is retracted, allowing spikes 1008 to spring out
and
transfix graft 1002.
Alternatively to a separate over-tube, graft holder 1004 itself may serve as
an over-
tube, for example, by connector 1006 being axially advanced in graft holder
1004 by a pusher
or a tube on which the connector is mounted (not shown).
In an exemplary embodiment of the invention, the above methods are varied so
that an
oblique eversion is achieved. In a first modification, over-tube 1010 is
oblique, so some spikes
are released first, and can pull down the graft before other spikes are
released. In a second
modification, not all spikes are the same length, so that some are released
first, even of over-
tube 1010 is not oblique.
Figs. 11A-11C illustrate a cap based technique for spike penetration, in
accordance
with an exemplary embodiment of the invention.
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Fig. 11 A shows a graft 1102 that is evened over a graft holder 1104 and a
connector
1106 having backwards pointing spikes 1108. Some of the spikes may have
penetrated graft
1102. A cap 1110 is provided that has an inner radius slightly greater than
the outer radius of
the evened graft.
In Fig. 11 B, cap 1110 is mounted on the evened portion of graft 1102. This
mounting
typically bends the spike tips further backwards and inwards. Axial and
rotational
manipulation of cap 1110 has been found to cause the spikes to penetrate the
evened portion of
graft 1102, as shown in Fig. 11 C.
Figs. 12A-12C illustrate a probe 1200 and a spike penetration method using the
probe,
in accordance with an exemplary embodiment of the invention. In an exemplary
embodiment
of the invention, the probe is used to individually force parts of a graft
1202 between a spike
1208 and a graft holder 1204, thus causing the spike to penetrate the graft,
possibly due to a
perpendicular angle crated between the spike tip and the graft. Possibly, as
shown, a wire
probe is used. Alternatively, other probe designs may be used. Alternatively
or additionally, to
using the probe to directly manipulate the graft tissue, in an exemplary
embodiment of the
invention, the probe is used to manipulate the spikes through the graft. For
example, the spikes
are pushed back using the probe so that they can be suddenly released and thus
penetrate the
graft.
Fig. 12A illustrates a Y shaped probe 1200, comprising a handle 1216, two arms
1212
and a thread 1214 connecting the two arms. Such a probe may be similar in
design to a
commonly used teeth cleaning (flossing) probe.
Fig. 12B shows a graft 1202 evened over a graft holder 1204 and a connector
1206
having backwards pointing spikes 1208. Thread 1214 of probe 1200 is shown
engaging a
portion of the evened graft between a spike tip and graft holder 1204. In Fig.
12B, the thread is
brought up, causing the spike tip to penetrate the graft. The rest of the
spikes may be handled
m turn.
In another exemplary embodiment of the invention, the spikes of the connector
are
mounted in a short hollow and sharp tipped tube. This tube maintains the
spikes to be axial, so
that they can more easily penetrate the vessel. Possibly, the spike tips are
not sharp, for
example to prevent inadvertent tissue penetration when deployed. After the
connector is
advanced (and the tubes penetrate the graft), the tubes are removed, for
example using
tweezers, so that the spike scan bend to their backwards pointing
configuration.
Figs. 13A and 13B illustrate a tool 1300 for oblique eversion, in accordance
with an
exemplary embodiment of the invention. Tool 1300 comprises a graft holding
tube 1304,
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CA 02393508 2002-06-03
WO 01/41623 PCT/IL00/00609
having at its end one or more finger extensions 1314. As will be shown in Fig.
13B, these
finger extensions serve to assist in evening some parts of a graft 1302 more
than others.
Although only two fingers, for one spike 1308 (explained below) are shown, a
plurality of
fingers, possibly or different lengths, may be provided on tube 1304. It
should be appreciated
that in this and other embodiments of the invention, the graft holder may be
used for delivering
the graft and/or the connector to the anastomotic connection. Alternatively, a
separate graft
holder for delivery may be provided.
Fig. 13B shows tool 1300 in operation. A graft 1302 is evened over the end of
tube
1304. Two spikes 1308 of a connector (not shown) are shown, one at a pan of
tube 1304 where
there are no fingers, and one near a finger 1314 (as shown also in Fig. 13A).
A portion 1310 of
graft 1302 is evened over one spike 1308. However, when a portion 1312 of
graft 1302 is
evened, portion 1312 is first be brought over a finger 1314, thus providing an
uneven eversion.
In some embodiments of the invention, the length of finger 1314 is
controllable, for example,
by finger 1314 comprising a movable bar mounted on an outside of tube 1304.
Alternatively or
additionally, fingers 1314 are pan of an inner tube (not shown) which is
optionally later
retracted or removed.
Figs. 14A and 14B illustrate a method of converting an even eversion into an
oblique
eversion, in accordance with an exemplary embodiment of the invention.
In Fig. 14A, a graft 1402 is shown evened over a graft holder 1404 and a pair
of spikes
1408 of a connector (not shown). A portion 1412 of graft 1402 is to be evened
more. In an
exemplary embodiment of the invention, portion 1412 is grasped by a tool, for
example a
tweezers, and pulled down, to the position shown in Fig. 14B. Spike 1408 may
be pulled out
of the graft by the motion. Possibly, the graft is first pulled off the spike.
A plurality of
positioning lines 1416 is shown. These lines may be used to indicate to the
evener, how much
of an oblique angle is generated by what amount of differential eversion.
Alternatively or
additionally, a line may be provided to mark a desired minimum eversion for
portion 1410.
Possibly, different line markings are provided for different vessel types
and/or different
anastomotic locations.
Figs. 15A-15C illustrate an alternative method of converting an even eversion
into an
oblique eversion, in accordance with an exemplary embodiment of the invention.
Fig. 15A is similar to Fig. 14A, except that a sliding pad 1516 is used
instead of
tweezers, to pull down a portion 1512 of a graft 1502 that is evened over a
graft holder 1504
and spikes 1508.
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Fig. 1 SB is a top view of fig. 1 SA, showing one or more inner barbs 1518 of
pad 1516,
engaging portion 1512, at or near spike 1508 or axially displaced therefrom.
In Fig. 15C, pad
1516 is pulled down, carrying along portion 1512, causing the eversion to
become oblique. As
in Figs. 14, positional lines may be provided to indicate to an evened a
desired degree of
differential eversion.
Figs. 16A and 16B illustrate a cap-like tool 1616 for converting a
perpendicular
eversion into an oblique eversion, in accordance with an exemplary embodiment
of the
invention. In Fig. 16A, a graft 1602 is shown evened over a graft holder 1640,
with two
evened portions 1610 and 1614 having substantially equal lengths. It should be
noted in this
and other figures, that a cut-through figure is shown, focusing on only two
points along the
graft circumference (and only two spikes, if any). However, the techniques are
generally
applied to complete grafts (and connectors with multiple, e.g., 6-8 spikes).
In Fig. 16B a cap 1616 is provided, having an inner diameter slightly greater
than the
outer diameter of graft holder 1604. The cap includes a lip 1618, which may be
longer adjacent
portion 1612 than adjacent portion 1610. A barb 1620, or other means for
engaging portion
1612 are provide inside lip 1618. In some cases, simply a roughening of the
inner surface is
sufficient to engage the graft. When cap 1616 is brought down, it pulls down
portion 1612, and
pulls down portion 1610 only slightly, if at all. An optional barb 1622 is
provided for portion
1610 as well. This optional barb may be used to ensure that portion 1612 is
not pulled too
much relative to portion 1610 - by pulling down portion 1610 as well, when a
desired relative
eversion is reached. The barbs may be movable, for example, to allow a user to
select different
relative eversion amount. In an exemplary embodiment of the invention, the
barbs comprises
an oblique tube removably mounted inside cap 1616.
The degree of differential eversion depends of the application. For example, a
normal
eversion may be 1-3 mm, with a longer eversion being 1-7 mm. This can result
in an eversion
angle of between, for example 85° and 25°.
Figs. 3 and 8-16 show tools that may be used outside the body or inside the
body, for
example, transvascularly, endoscopicly or throactoscopicly. In an exemplary
embodiment of
the invention, the various caps are radially compressed and provided through
the lumen of the
graft. Alternatively, the caps may be provided as an over tube. In anther
example, the various
probes, tweezers and pads may be provided as an over tube. Wires or bars may
be provided to
providing retraction and rotation forces, respectively.
Once the graft is evened, it is typically provided into an incision in the
target vessel. In
an exemplary embodiment of the invention, the incision is formed using a hole
punch. In an
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WO 01/41623 PCT/IL00/00609
exemplary embodiment of the invention, the hole punch also carries forward
spikes of the
anastomotic connector into the target vessel.
Fig. 17 illustrates an exemplary combined hole punch and connector insener
tool 1700,
in accordance with an exemplary embodiment of the invention.
Tool 1700 comprises a body 1712 and a retractable tip 1714, that define a
tissue
receptacle 1716 between them. In operation, tip 1714 is inserted into a blood
vessel (e.g.,
making a hole by virtue of its sharp tip or entering into an existing
incision), so that the blood
vessel tissue is captured by receptacle 1716. When tip 1714 is retracted, the
tissue in the
receptacle is punched out. Body 1712 is then advanced into the punched out
hole. Optionally,
the sharp tip portion of tip 1714 is retractable, to prevent damage to the
opposite side of the
target vessel, during the motion.
In an exemplary embodiment of the invention, an anastomotic connector is
provided
into the blood vessel by body 1712. In an exemplary embodiment of the
invention, the
connector is a two part connector, comprising a ring 1708 and a set of spikes
1710 inserted
through the ring and an evened portion of a graft 1702. In an exemplary
embodiment of the
invention, spikes 1710 are mounted on a base 1706, which can be retracted, to
perform the
anastomosis.
In an exemplary embodiment of the invention, spikes 1710 include curved tips
1718
which are held in a recess 1720 in body 172. Thus, when body 1712 is advanced
into the target
vessel (possibly partially axially), the tips 1718 enter the vessel. Then the
tips are retracted,
they engage the vessel and pull the rest of the connector and evened graft
1702 to complete the
anastomosts.
Various methods may be used to maintain tips 1718 inside recess 1720. In an
exemplary embodiment of the invention, tips 1718 are pre-disposed (e.g. pre-
bent or pre-
stressed) to be bent inwards. Tips 1718 may be radially extended when spikes
1710 are
retracted, by ring 1708 or by the widening of body 1712 outside of the
recesses.
Optionally, tips 1718 may be mechanically held in recesses 1720. In an
exemplary
embodiment of the invention, recesses 1720 include a protrusion 1721 that is
perpendicular to
the figure plane. For example, the front view of recesses 1720 having the form
of an "I". Thus,
radial motion of tips 1718 is prevented. However, if body 1712 is rotated
relative to tips 1720,
the tips bypass the protrusion and can self expand radially
Figs. 18A and 18B illustrate a graft delivery system 1800, in accordance with
an
exemplary embodiment of the invention.
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A graft 1802 is shown inserted through a hole 1814 in a graft holder 1804. For
clarity,
the everted tip of graft 1802 is not shown, however, it exits through an
opening 1805 at the tip
of graft holder 1804. Tips of a plurality of spikes 1808 are shown, such that
graft holder
maintains the spikes bent inwards, for example as shown in Fig. 10A and l OB,
except that the
tips of the spikes are allowed to protrude, for example as shown in Fig. 15A.
A switch 1816 is
provided to advance spikes 1808, thereby causing them to spring out and
penetrate the graft
(extension shown in Fig. 18B). A knob 1820 is provided for advancing the
connector relative
to graft holder 1804 and then retracting and removing the graft holder.
Possibly, a safety 1818
is provided, to prevent inadvertent actuation of tool 1800.
In an exemplary embodiment of the invention, graft holder 1804 is removed by
its
retracting over a knife 1810, which splits the graft holder into two. The rest
of graft holder
1804 is already split in two, for example at opening 1814. In an exemplary
embodiment of the
invention, the splitting line is not a shortest straight line, at least not
between opening 1814
and knife 1810 (indicated by reference 1812), to prevent graft 1802 from
catching on split line
1812.
In an exemplary embodiment of the invention, graft 1802 is inserted to opening
1805
by pushing it into opening 1814. Alternatively, graft 1802 is pulled, for
example using a lasso
(possibly similar to that described above) around its end, which is provided
through opening
1804. During the motion of graft 1802 there is a danger that it will get
caught on the spilt line.
By providing a non-straight spilt line 1812, as shown, which does not meet
opening 1814 at
the along the device axis, but at its side, such catching is preferably
prevented.
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
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CA 02393508 2002-06-03
WU O1/4162~ PCT/IL00/00609
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.
27
