U.S. patent application number 15/946071 was filed with the patent office on 2018-11-15 for vessel closure device.
The applicant listed for this patent is Abbott Laboratories. Invention is credited to Brian A. Ellingwood.
Application Number | 20180325506 15/946071 |
Document ID | / |
Family ID | 38877651 |
Filed Date | 2018-11-15 |
United States Patent
Application |
20180325506 |
Kind Code |
A1 |
Ellingwood; Brian A. |
November 15, 2018 |
VESSEL CLOSURE DEVICE
Abstract
The present invention relates to closing an opening within a
subcutaneous bodily vessel by using a spiral closure device to
engage tissue around the opening. The spiral closure device is
adapted to be threaded into the vessel wall surrounding the opening
in the bodily vessel. A deployment mechanism may be used to rotate
the spiral closure device. As the deployment mechanism is rotated
the spiral closure device is rotated such that a tip of the spiral
closure device engages the vessel wall around the opening in the
bodily vessel. Continued rotation of the spiral closure device
threads the closure device through the tissue around the opening.
The closure device may have a tapered configuration in which the
distal end is larger than the proximal end. As the distal end is
threaded through the vessel wall, the narrowing closure device
pulls the vessel wall tissue together, thereby effectively closing
the opening.
Inventors: |
Ellingwood; Brian A.;
(Sunnyvale, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Abbott Laboratories |
Abbott Park |
IL |
US |
|
|
Family ID: |
38877651 |
Appl. No.: |
15/946071 |
Filed: |
April 5, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14023428 |
Sep 10, 2013 |
9962144 |
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15946071 |
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11427309 |
Jun 28, 2006 |
8556930 |
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14023428 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00685
20130101; A61B 2017/00663 20130101; A61B 2017/0649 20130101; A61B
2017/00862 20130101; A61B 17/0057 20130101; A61B 2017/00659
20130101 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1.-20. (canceled)
21. A device for engaging tissue, the device comprising: a first
coil member and a second coil member, each configured to engage
tissue, the first and second coil members forming a
double-helix.
22. The device of claim 21, wherein coils of the first coil member
are perpendicular to coils of the second coil member.
23. The device of claim 21, wherein a pitch between adjacent coils
of the first coil member are equidistant.
24. The device of claim 21, wherein a pitch between adjacent coils
of the second coil member are equidistant.
25. The device of claim 21, wherein a pitch between adjacent coils
of the first coil member are different.
26. The device of claim 21, wherein a pitch between adjacent coils
of the second coil member are different.
27. The device of claim 21, wherein each of the first coil member
and the second coil member comprises a wire.
28. The device of claim 21, wherein each coil of the first coil
member and the second coil member is wound in an irregular
geometric shape.
29. The device of claim 21, wherein the first coil member and the
second coil form a generally cylindrical shape to the device.
30. The device of claim 21, wherein the first coil member and the
second coil member form a taper to the device.
31. A system for engaging tissue, the system comprising: a device
comprising a first coil member and a second coil member, the first
and second coil members forming a double-helix, the first coil
member and the second coil forming a generally cylindrical shape to
the device; and a closure system operatively cooperating with the
device to rotate the device into tissue.
32. The system of claim 31, wherein the first coil member comprises
a tissue penetrating tip.
33. The system of claim 31, wherein the closure system comprises a
deployment member cooperating with a proximal end of the device,
the deployment member configured to rotate the device.
34. The system of claim 31, wherein the deployment member comprises
a retention recess to receive a proximal end of the device.
35. The system of claim 34, wherein the retention recess is
curved.
36. The system of claim 31, wherein the first coil member and the
second coil member are formed from an alloy.
37. The system of claim 31, further comprising a member configured
to aid with aligning the device.
38. The system of claim 37, wherein the member is a bleed-back
device.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This is a continuation of U.S. patent application Ser. No.
14/023,428, filed 10 Sep. 2013, now U.S. Pat. No. 9,962,144, which
is a continuation of U.S. patent application Ser. No. 11/427,309,
filed 28 Jun. 2006, U.S. Pat. No. 8,556,930, the disclosures of
which are incorporated herein by reference in their entireties.
BACKGROUND OF THE INVENTION
1. The Field of the Invention
[0002] Exemplary embodiments of the present invention generally
relate to apparatus, systems and methods for closing an opening in
a body vessel of a human or animal. More particularly, embodiments
of the present invention generally relate to devices for engaging
tissue around an opening in a body vessel formed during a
percutaneous medical procedure, and to systems and methods for
using such devices.
2. The Relevant Technology
[0003] One element in any medical procedure is the control and
stoppage of blood loss. Stopping blood loss is a particular concern
in intravascular medical procedures where a laceration in a vein or
artery is made to grant venous or arterial access. Such procedures
may be diagnostic or therapeutic in nature, and commonly involve,
for example, the insertion, use, and removal of a catheter or stent
to diagnose or treat a medical condition. During the procedure, an
introducer sheath may allow introduction of various devices into
the vessel while also minimizing blood loss during the procedure.
Upon completion of the procedure, however, the devices and the
introducer may be removed, thereby leaving a laceration or puncture
in the vessel wall.
[0004] This laceration or puncture site is of particular concern in
controlling the patient's blood loss. If the site is left unsealed,
blood may escape and enter into the surrounding body cavities and
tissue. Where excessive blood escapes, the effectiveness of the
medical procedure may be compromised and complications may arise.
To avoid or counter these complications, the medical staff must be
vigilant in providing continued care to the patient following an
intravascular procedure.
[0005] One method used to avoid excessive bleeding is to apply
pressure to the affected area. This process attempts to block flow
from the body vessel until the natural clotting process is
complete. Pressure may be manually applied, or with a sandbag,
bandage, or clamp. Moreover, the effectiveness of this pressure is
compromised unless the patient remains nearly motionless while the
pressure is applied. Patients are monitored during the time during
which clotting is occurring, thereby also requiring much of a
physician's or nurse's time. Typically, this natural process takes
up to two hours; however, with other patients even more time may be
required. The need for the patient to be immobilized can cause
discomfort to the patient. In addition, the time for hemostasis
potentially increases both the time during which the medical staff
must monitor the patient as well as the patient's hospital stay,
thus adding to the expense of the procedure.
[0006] Additional devices and techniques have been suggested to
reduce the amount of time for hemostasis by percutaneously sealing
a vascular opening by plugging, suturing and/or mechanically
closing the puncture site. For example, collagen plugs are well
known in the art. The collagen plug may be deployed into the
vascular opening through an introducer sheath. When deployed, the
blood or other body fluids cause the collagen plug to swell, such
that it blocks the access site and provides hemostasis. Such
devices may, however, be difficult to properly position in the
vessel. Consequently, an improperly deployed plug may block the
flow of fluid in the vessel, and/or be released into the blood
stream where it can float downstream and potentially embolize.
[0007] Other mechanical devices or methods have been suggested for
closing a puncture site. By way of example, a staple may be used.
In one configuration, an "S" shaped staple includes barbs that may
engage tissue on either side of the wound. Another staple may be
ring-shaped and include barbs that project from the ring. Sides of
the ring can be squeezed to separate the barbs, while the barbs may
engage the tissue on either side of the wound. The sides can then
be released, causing the barbs to return closer together, thereby
also pulling the tissue closed over the wound. These staples,
however, have a large cross-sectional profile and may not be easy
to deliver through a percutaneous access site to close an opening
in a vessel wall.
[0008] Accordingly, there remains a need for a vascular closure
device which promotes rapid hemostasis and which can be easily
positioned and deployed into a small access site to close an
opening or puncture in a bodily vessel.
BRIEF SUMMARY OF THE INVENTION
[0009] Exemplary embodiments of the invention relate to a closure
device for closing an access site in a bodily vessel following a
percutaneous medical procedure. The closure device reduces the risk
of bleeding following a medical procedure by improving the ability
of medical personnel to quickly and easily close an access site of
a blood vessel. The use of the closure device accelerates
hemostasis in the patient, thus reducing the health risks
associated with excess blood loss. Additionally, the vessel closure
device allows a patient a near full range of motion soon after
surgery, thus reducing the expenses of the procedure and
corresponding hospital stay.
[0010] In one embodiment of the present invention, a vessel closure
device includes a spiral clip. The spiral clip may be adapted to
engage the tissue surrounding an opening in a bodily vessel,
thereby pulling the tissue together and closing the opening. For
example, the spiral clip may engage the walls of a blood vessel and
pull the vessel walls together to close the opening. In some
embodiments, the spiral clip can be a wire having a plurality of
coils. Optionally, the spiral clip can be tapered such that one end
of the clip can be wider than a second end of the clip. In another
alternative, the medial portion of the clip may be wider than
either end of the clip.
[0011] The spiral clip engages the vessel walls or other tissue
when rotated. For example, the spiral clip may be a helically wound
wire which, when rotated, extends into the vessel wall around the
vascular opening. In other embodiments, the spiral clip can be a
fastener with spiral threads, or a helical wire wound around a
fastener, and grips the vessel walls when rotated. The spiral clip
may be rotated by a deployment mechanism. The deployment mechanism
may rotate in a first direction to facilitate engagement of the
spiral clip with the tissue, or be rotated in a second direction to
disengage the clip from the deployment mechanism. Optionally, the
clip may be hollow or have an opening therein for receiving a
vessel locator which can be positioned in the opening, through the
clip, to determine the location of the opening in the bodily vessel
so as to properly position the spiral clip.
[0012] In another embodiment, a system for closing an opening in a
bodily vessel is described. Such system may include, for example, a
spiral closure device and a deployment mechanism having an opening
therein to receive the spiral closure device. The deployment
mechanism can deploy the spiral closure device by rotatably
engaging the closure device to thereby close an opening in a bodily
vessel. The spiral closure device may also be compressible to allow
it to be received within the deployment mechanism. For instance,
the closure device may be a tapered helical wire which has a
natural shape that, at least in part, can be of a size that would
not fit within the deployment mechanism but which, when compressed,
can be received therein.
[0013] The deployment mechanism can, in some embodiments, include a
tube in which the spiral closure device can be received. Further
embodiments may also include a plunger within the tube, and such
that the plunger traverses the tube along an axis of the tube and
rotatably engages the spiral closure device. The deployment
mechanism may further be threaded to facilitate movement of the
spiral closure device into the vascular opening. For example, a
plunger may have external threads on its outer surface, while a
tube has mating internal threads on an inner surface, such that as
the plunger can be rotated, the plunger moves along an axis of the
tube. In other embodiments, the inner surface of the tube has
external threads and the outer surface of the plunger has internal
threads. In yet another embodiment, a tube may have internal
threads in which coils of a helical wire are received and such that
as the spiral closure device can be rotated, it moves along the
threads and along an axis of the tube.
[0014] A vessel closure system may also include a vessel locator
for positioning the spiral closure device in the vascular opening.
For example, a tube or other type of bleed-back device may be used.
For instance, the bleed-back device can be inserted through the
deployment mechanism and/or the spiral closure device. When the
bleed-back device finds the vascular opening, it can be inserted
into the lumen of the vessel such that blood or other bodily fluids
are received in the device and flow through the device to exit at
the distal end. This provides a visual indication to the medical
personnel using the closure device that the vessel closure system
is positioned for deployment. Upon viewing the fluid, and thereby
determining that the locator and deployment mechanism are in place,
the spiral closure device can be deployed and the vascular opening
closed.
[0015] In other embodiments, a method for installing a vessel
closure device is disclosed. The method can include, for example,
locating the opening in the bodily vessel and positioning the
deployment mechanism at the opening. Thereafter, and using the
deployment mechanism, a spiral closure device can be deployed into
the opening such that the spiral closure engages and pulls together
the vessel wall tissue surrounding the opening. Locating the
opening can further include extending a vessel locator through the
deployment mechanism and/or closure device into a lumen of a bodily
vessel and determining that fluid from the lumen is being received
through the vessel locator.
[0016] The deployment mechanism can include a tube and a deployment
member moving along an axis of the tubular receiving member. As
such, using the deployment mechanism to rotatably deploy the spiral
closure device may include removably mounting the spiral closure
device to the deployment member and rotating the deployment member
such that rotating the deployment member moves it along the axis of
the receiving member and causes the spiral closure device to
rotatably engage the vessel wall tissue.
[0017] These and other objects and features of the present
invention will become more fully apparent from the following
description and appended claims, or may be learned by the practice
of the invention as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] To further clarify the above and other advantages and
features of the present invention, a more particular description of
the invention will be rendered by reference to specific embodiments
thereof which are illustrated in the appended drawings. It is
appreciated that these drawings depict only typical embodiments of
the invention and are therefore not to be considered limiting of
its scope, nor are they necessarily drawn to scale. The invention
will be described and explained with additional specificity and
detail through the use of the accompanying drawings in which:
[0019] FIG. 1 illustrates a perspective view of a closure device in
accordance with one embodiment of the invention;
[0020] FIG. 2A is partial cut-away view illustrating one embodiment
of a system for closing an opening in a vessel wall using a spiral
closure device;
[0021] FIG. 2B illustrates a bottom view of a deployment member
having a retention sleeve or recess for receiving a spiral closure
device;
[0022] FIG. 3 illustrates the vessel wall of FIG. 2A after
deployment of a spiral closure device to close an opening in the
wall, according to one embodiment of the invention;
[0023] FIG. 4 illustrates an alternative embodiment of a vessel
closure device;
[0024] FIG. 5 illustrates a vessel closure device according to yet
another embodiment of the present invention; and
[0025] FIG. 6 illustrates an exemplary deployment mechanism for use
in rotatably deploying a spiral closure device according to one
embodiment of the present invention.
[0026] FIG. 7 illustrates an alternative embodiment of a vessel
closure device
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] Exemplary embodiments of the present invention include
delivery of a closure device for closing an opening or other
laceration or puncture in the wall of a bodily vessel, thereby
promoting hemostasis. When inserted into a vessel wall, the vessel
closure device improves patient safety by drawing the vessel wall
together, thereby reducing or eliminating leakage from the blood
vessel into the surrounding tissue. The vessel closure device may
be useful for a variety of medical procedures accessing blood
vessels or other bodily vessels such as, for example, bodily
cavities or bodily organs. The use of a closure device according to
embodiments of the present invention can improve patient safety
while also being capable of quick and efficient positioning and
installation.
[0028] Referring now to FIG. 1, an exemplary embodiment of a vessel
closure device 10 is illustrated. In the illustrated embodiment,
vessel closure device 10 comprises a wire 12 wound in a helical
shape such that it has a spiral configuration. More specifically,
wire 12 is wound such that it has a plurality of coils 18. In this
illustrated embodiment, coils 18 are substantially parallel,
although it will be appreciated in light of this disclosure that
this is not necessary and coils 18 can have any of a variety of
configurations. For example, and not by way of limitation, vessel
closure device 10, such as vessel closure device 10a of FIG. 7, may
include a second wire 12b such that a double-helix is formed, and
in which the coils of the second wire are perpendicular to the
coils of the first wire 12a. Further, the spacing or pitch between
adjacent coils 18 of the wire 12 can be equidistant, different
spacing, or combinations of equal or different spacings.
[0029] Vessel closure device 10 may also have any number of coils
or any of a variety of shapes and configurations. For example, in
the illustrated embodiment, wire 12 is wound such that vessel
closure device 10 is substantially conical. More particularly, when
viewed from above or below, coils 18 of vessel closure device 10
are generally circular in shape, and gradually reduce in size from
distal end 16 to proximal end 14. In this manner, the diameter of a
coil adjacent proximal end 14 is less than the diameter of a coil
at distal end 16.
[0030] As discussed in more detail hereafter, one feature of a
tapered configuration on vessel closure device 10 is the ability of
vessel closure device 10 to effectively close an opening in a
vessel wall. In particular, distal tip 17 can enter the vessel wall
and coils 18 can thereafter be threaded around an opening in the
vessel. As threading continues, the more narrow coils of vessel
closure device 10 engage the vessel wall tissue and pull the wall
together, thereby closing the opening.
[0031] Although a tapered configuration to vessel closure device 10
is illustrated, it will be understood by those skilled in the art
that other configurations are possible and the illustrative nature
of the exemplary embodiment should not be considered limiting to
the various other configurations that are possible. For example,
wire 12 may be wound in any number of manners. For instance, wire
12 may be wound such that vessel closure device 10 has a generally
cylindrical shape, with or without a taper, as shown in FIG. 7, or
other configurations having only a portion of the device being
tapered. Moreover, it is not necessary that the coils have a
generally circular shape. For example, coils 18 may wound in any
other regular or irregular geometric shape. By way of
representation, the shape of one or more of coils 18 may be
generally oval, diamond, trapezoidal, or the like.
[0032] Moreover, the cross-sectional shape and configuration of
wire 12 is not limited to any particular design. For example, while
wire 12 may have a substantially circular or elliptical
cross-sectional shape, this feature is not limiting. For instance,
in other embodiments, wire 12 has other cross-sectional shapes,
such as but not limited to, triangular, square, diamond-shaped, and
trapezoidal cross-sections.
[0033] Now referring to FIG. 2A, a system and method for installing
vessel closure device 10 is illustrated and described in greater
detail. As illustrated, one embodiment of a vessel closure system 5
is located at an opening 52 in a bodily vessel 50, and adapted to
close opening 52 to prevent fluid loss from a lumen 54 of vessel
50. In this embodiment, vessel closure system 5 can include a
delivery mechanism, including a delivery shaft 30 and a deployment
member 40 disposed within delivery shaft 30, and vessel closure
device 10 for closing opening 52.
[0034] Vessel closure device 10 may also be disposed within, and
received by, delivery shaft 30. In particular, in this exemplary
embodiment, delivery shaft 30 includes a chamber 32 extending from
a proximal end 38 toward a distal end 36 of delivery shaft 30. For
instance, in one configuration the chamber 32 runs along the length
of delivery shaft 30. Chamber 32 is configured, in this embodiment,
to receive both delivery shaft 30 and vessel closure device 10. For
instance, chamber 32 may have a cross-sectional shape or
configuration generally corresponding to the cross-sectional shape
of deployment member 40, and slightly larger than deployment member
40. Accordingly, deployment member 40 can be easily inserted into
chamber 32.
[0035] In other embodiments, however, chamber 32 can have a size
about equal to or slightly less than the size of at least a portion
of deployment member 40. In such embodiments, a seal and/or
compression fit can be formed between deployment member 40 and the
internal surface 39 of delivery shaft 30 which surrounds chamber
32. By forming a compression fit and/or seal within chamber 32,
closure system 5 can act to restrict passing fluid along the length
of delivery shaft 30. For instance, fluid that collects in the
portion of delivery shaft 30 which is adjacent vessel 50 can be
prevented from passing through delivery shaft 30 to the medical
personnel operating closure system 5.
[0036] It will be understood that the mounting or mating of
deployment member 40 with delivery shaft 30 can occur in various
other manners. For instance, in another configuration, one or more
mechanical seals, such as but not limited to, O-rings, can be
mounted to a portion of deployment member 40 and be disposed
between deployment member 40 and internal surface 39 of delivery
shaft 30 and prevent fluid passing through delivery shaft 30.
[0037] In addition to or alternatively to creating a seal between
deployment member 40 and internal surface 39 of delivery shaft 30,
closure system 5 can include a seal 37 mounted to proximal end 38
of delivery shaft 30. This seal 37 can be one of a variety of
different seals, including optionally being self-sealing once it is
inserted into proximal end 38 of delivery shaft 30. The seal 37,
for example, may have an elastomeric body, such as silicone rubber
or other material, with at least one slit and/or other collapsible
opening formed therein to allow movement of deployment member 40.
The collapsible openings or other portions of the seal 37 maintain
a fluid tight seal with or against deployment member 40. Thus,
blood or other bodily fluids are prevented from leaking out, and
unwanted air is prevented from entering into the body. Examples of
such flexible membranes or seals which can be utilized with the
present invention are shown in U.S. Pat. Nos. 4,798,594, 5,176,652,
and 5,453,095 the entireties of which are herein incorporated by
reference.
[0038] In the illustrated embodiment, deployment member 40 can be
disposed within chamber 32 and can be further configured to mount
vessel closure device 10 to vessel 50 and thereby close opening 52.
For example, in this embodiment, deployment member 40 can include a
first, mounting portion 46 and a second, rotation portion 44.
Mounting portion 46 has, in this embodiment, a generally circular
cross-section and a diameter about equal to the diameter of the
cross-section of chamber 32, and is further disposed within channel
32. In contrast, rotation portion 44 has a diameter less than the
diameter of mounting portion 46.
[0039] Mounting portion 46 is, in this embodiment, adapted to
engage vessel closure device 10, such that it can be secured within
channel 32. For instance, mounting portion 46 may include a
retention sleeve or recess 42 through which a proximal tip 15 (FIG.
1) of proximal end 14 can be inserted. Retention sleeve or recess
42, which is shown in more detail in FIG. 2B and without vessel
closure device 10, can retain proximal end 14 in any suitable
manner. For instance, sleeve or recess 42 can include a curved
channel 48 having a shape generally corresponding to the helical
shape of proximal end 14 of vessel closure device 10. Accordingly,
curved channel 48 can be ramped or inclined along its length such
that it approximates the shape contour of vessel closure device 10
at proximal end 14. In other embodiments, curved channel 48 may not
be ramped along its length. For instance, all or a portion of the
length of curved channel 48 may be substantially horizontal. In
this manner, as proximal end 14 of vessel closure device 10 is
inserted into curved channel 48, proximal end 14 is compressed and
frictionally retained within retention sleeve or recess 42.
[0040] In light of the disclosure herein, it should be appreciated
that any number of other mechanisms or retention devices may be
used to engage vessel closure device 10 or otherwise secure vessel
closure device 10 within channel 32. For instance, mounting portion
46 may be temporarily or permanently charged such that a magnetic
field is created. Vessel closure device 10 may further be made of a
ferrous material, or include a ferrous material portion or a
coating of ferrous material, and attracted to mounting portion 46
by the magnetic field or be charged with an opposite charge. In
other embodiments, mounting portion 46 may include a clasp for
receiving proximal end 14. It will also be understood that
combinations of the above are also possible.
[0041] Rotation portion 44 can be connected to mounting portion 46.
Rotation portion 44 may, for example, be integrally formed with
mounting portion 46 or otherwise directly or indirectly connected
thereto. In some embodiments, rotation portion 44 can be configured
to be rotated by the medical personnel using closure system 5 to
position vessel closure device 10. By rotating rotation portion 44,
such as grasping a portion of a proximal portion of the rotation
portion 44, the medical personnel also rotates mounting portion 44,
as well as vessel closure device 10.
[0042] Rotational motion of rotating vessel closure device 10
causes distal end 16 of vessel closure device 10 to engage the
vessel wall tissue 51 surrounding opening 52. Moreover, by rotating
deployment member 30, the medical personnel can cause deployment
member 30 to move along the axis of chamber 32 in a direction
toward vessel 50. Correspondingly, rotation of deployment member 30
causes vessel closure device 10 to rotate and move along the axis
of chamber 32. In this manner, and as discussed in more detail
hereafter, as rotation portion 44 is rotated, vessel closure device
10 is threaded into vessel wall 51 around opening 52. Thus,
deployment member 40 can act as a plunger or piston within delivery
shaft 30 by rotatably pushing vessel closure device 10 into opening
52.
[0043] Although FIG. 2A illustrates mounting portion 46 and
rotation portion 44 as having differing sizes, in light of the
disclosure herein it should be appreciated that this feature is not
limiting. For instance, mounting portion 46 and rotation portion 44
may be integrally formed as a shaft in which each portion has the
same cross-sectional shape and the same size. It should be noted
that the mounting portion 46 can have a configuration similar to
the interior diameter or configuration of the chamber 32 or a
configuration enables slidable and/or rotatable cooperation between
the mounting portion 46 and the chamber 32.
[0044] With continued reference to FIG. 2A, it will be seen that to
deploy vessel closure device 10 and thereby close opening 52,
vessel closure device 10 may, in some embodiments, be flexible.
This feature may be desirable for a number of reasons. For example,
the width or diameter of channel 32 may be less than the width or
diameter of one or more coils of vessel closure device 10. In such
a case, a flexible vessel closure device 10 allows the larger width
portion or portions of vessel closure device 10 to be deformed so
as to fit within channel 32.
[0045] In one embodiment, for example, vessel closure device 10,
when in a natural state, is tapered such that a width at the distal
end of the device is larger than the width at the proximal end.
Where the width at the distal end is larger than channel 32, the
distal end may be bent or otherwise deformed to fit within channel
32. Such deformation may, for example, compress the coils by
reducing the width of one or more coils. In some embodiments, to
reduce the width of the coils may further increase the length of
vessel closure device 10.
[0046] Once vessel closure device 10 is positioned within channel
32, whether or not such positioning requires deformation of vessel
closure device 10, deployment member 40 can engage vessel closure
device 10 and/or be mounted thereto to deploy vessel closure device
10 into opening 52 in vessel walls 51. Such deployment of vessel
closure device 10 into opening 52 may be caused in any suitable
manner, including those described herein. For example, rotating
deployment mechanism 40 to move deployment mechanism 40 along the
interior of delivery shaft 30 rotates vessel closure device 10 into
vessel walls 51. As deployment mechanism 40 rotates and translates,
it rotates vessel closure device 10 and pushes it toward distal end
34 of delivery shaft 30. At distal end 34, distal tip 17 of vessel
closure device 10 exits delivery shaft 30 and is pressed against
vessel walls 51.
[0047] When distal tip 17 is pushed against vessel walls 51, it can
enter into vessel walls 51 adjacent opening 52. Distal tip 17 can
have any suitable configuration. For instance, distal tip 17 can be
flat or blunt, rounded, or can have a sharpened tip or sharpened
edges that extend to a sharpened tip, or can have any combination
thereof. As should be appreciated in light of the disclosure
herein, a sharpened distal tip 17 can facilitate entry of vessel
closure device 10 into vessel 50. However, this feature is not
limiting as the forces applied to vessel closure device 10 to cause
its rotational and/or translational motion can also be sufficient
to cause a blunt or rounded distal tip 17 to enter and engage
vessel wall tissue 51.
[0048] As vessel closure device 10 continues to rotate and
translate, distal tip 17 rotates around opening 52 and through
vessel walls 51, and moves deeper into vessel walls 51. In effect,
this provides a threading action and vessel closure device 10 can
be threaded through vessel walls 51 surrounding opening 52.
Accordingly, as this rotation and translation continues, proximal
end 14 of vessel closure device 10 is also moved closer to, and can
engage, vessel walls 10.
[0049] In some embodiments, such as where vessel closure device 10
is deformed when placed in the deployment mechanism comprising
delivery shaft 30 and deployment member 40, vessel closure device
10 may change shape upon exiting distal end 34 of delivery shaft
30. For instance, where the width of a coil of the vessel closure
device 10 has been compressed, the coil may return to its natural
shape and size upon exiting delivery shaft 30. Accordingly, and by
way of example, where vessel closure device 10 has a natural
conical or tapered configuration, vessel closure device 10 may
return to that natural shape when vessel closure device 10 is
displaced from the deployment mechanism.
[0050] A variety of benefits may be obtained by deforming vessel
closure device 10 to fit within delivery shaft 30 of a deployment
mechanism and thereafter allowing vessel closure device 10 to
return to its natural shape. For instance, where the deformation
decreases the width or size of vessel closure device 10, a smaller
delivery shaft 30 may be inserted into a patient beneath the skin.
This allows a smaller incision to be used with the patient, thereby
also decreasing the pain, recovery time, and scarring associated
with the incision.
[0051] In addition, recapture of the natural shape of vessel
closure device 10 can, in some embodiments, effectively close
opening 52 in vessel walls 51 and bring portions of surface 56 of
vessel walls 51 into together or towards each other. For instance,
with reference now to FIG. 3, an exemplary embodiment of vessel
closure device 10 deployed within and closing opening 52 is
illustrated following removal of the deployment mechanism. In the
illustrated embodiment, the height of vessel closure device 10 can
be about equal to the thickness of the vessel walls 51 and the
width of vessel closure device 10 can be slightly larger than the
width of the opening in vessel 50. Accordingly, as vessel closure
device 10 is inserted into the patient, it is secured to the vessel
walls 51 accessible through opening 52, such as through surface 56,
rather than the bodily tissue surrounding the vessel.
Alternatively, the vessel closure device 10 can be secured to any
portion of the vessel walls 51, whether or not through surface
56.
[0052] As will be appreciated in light of the disclosure herein,
the illustrated configuration and size of vessel closure device 10
is not necessarily a limiting feature of the present invention. In
particular, the size of vessel closure device 10 can be varied in
any suitable manner as necessary for a particular application. For
instance, vessel closure device 10 can be produced in any of
various sizes suitable for a patient, medical procedure and/or body
lumen which is being accessed.
[0053] As illustrated, vessel closure device 10 has a natural shape
that is generally conical or tapered. The wider, distal end of
vessel closure device 10 was first threaded into vessel walls 51
and vessel closure device 10 was thereafter threaded deeper into
vessel walls 51. As vessel closure device 10 was threaded deeper
into vessel walls 51, and the width of vessel closure device 10
becomes increasingly narrow, vessel closure device 10 continues to
engage vessel wall tissue 51. As vessel closure device 10 narrows,
it naturally pulls the tissue surrounding opening 52 together,
thereby closing opening 52 or at least reducing the size of opening
52 to restrict the amount of fluid that can flow through opening
52.
[0054] To obtain these and other characteristics, in one
embodiment, a closure device can be comprised of biocompatible
materials that are at least temporarily deformable. Suitable
biocompatible materials include, for example, superelastic
materials (e.g., Nitinol). In addition, and by way of
representation only, other suitable materials may include stainless
steel, silver, platinum, tantalum, palladium, cobalt-chromium
alloys, niobium, iridium, any equivalents thereof, alloys thereof
or combinations thereof.
[0055] In addition, embodiments of a closure device may comprise a
shape memory material. For example, the shape memory material can
be shaped in a manner that allows deformation and restriction to
induce a substantially tubular, linear orientation while within a
delivery shaft, but can automatically retain the memory shape of
the vessel closure device once extended from the delivery shaft.
Shape memory materials have a shape memory effect in which they can
be made to remember a particular shape. Once a shape has been
remembered, the shape memory material may be bent out of shape or
deformed and then returned to its original shape by unloading from
strain or by heating. Typically, shape memory materials can be
shape memory alloys ("SMA") comprised of metal alloys, or shape
memory plastics ("SMP") comprised of polymers or shape memory
metals ("SMM").
[0056] Usually, an SMA can have any non-characteristic initial
shape that can then be configured into a memory shape by heating
the SMA and confirming the SMA into the desired memory shape. After
the SMA is cooled, the desired memory shape can be retained. This
allows for the SMA to be bent, straightened, compacted, and placed
into various contortions by the application of requisite forces;
however, after the forces are released the SMA can be capable of
returning to the memory or natural shape. The main types of SMAs
include: copper-zinc-aluminum; copper-aluminum-nickel;
nickel-titanium ("NiTi") alloys known as Nitinol; and
cobalt-chromium-nickel alloys or cobalt-chromium-nickel-molybdenum
alloys known as Elgiloy. However, other types of SMAs can be used.
Typically, the nitinol and Elgiloy alloys can be more expensive,
but have superior mechanical characteristics in comparison with the
copper-based SMAs. The temperatures at which the SMA changes its
crystallographic structure are characteristic of the alloy, and can
be tuned by varying the elemental ratios.
[0057] For example, it is contemplated that the wire or one or more
other materials forming a vessel closure device be comprised of a
Ni-TI alloy that forms superelastic Nitinol. In the present case,
Nitinol materials can be trained to remember a certain shape (e.g.,
a tapered or non-tapered helical coil). Thereafter, the materials
can be deformed in the delivery shaft, an introducer, dilator, or
some other tube, and then be released to return to its trained
shape. Also, additional materials can be added to the Nitinol
depending on the characteristics desired.
[0058] An SMP is a shape-shifting plastic that can be fashioned
into a vessel closure device in accordance with the present
invention. When an SMP encounters a temperature above the lowest
melting point of the individual polymers, the blend can make a
transition to a rubbery state. The elastic modulus can change more
than two orders of magnitude across the transition temperature. As
such, an SMP can be formed into a desired shape of a closure device
by heating it above the transition temperature, fixing the SMP into
the new shape, and cooling the material below the transition
temperature. The SMP can then be arranged into a temporary shape by
force, and then resume the memory shape once the force has been
applied. Examples of SMPs include biodegradable polymers, such as
oligo( -caprolactone)diol, oligo(.rho.-dioxanone)diol, and
non-biodegradable polymers such as, polynorborene, polyisoprene,
styrene butadiene, polyurethane-based materials, vinyl
acetate-polyester-based compounds, and others yet to be determined.
As such, any SMP can be used in accordance with the present
invention.
[0059] For example, Veriflex.TM., the trade name for CRG's family
of shape memory polymer resin systems, currently functions on
thermal activation which can be customizable from -20.degree. F. to
520.degree. F., which allows for customization within the normal
body temperature. This allows a vessel closure device comprised of
Veriflex.TM. to be inserted into a delivery shaft. Once
unrestrained by the delivery shaft, the body temperature can cause
the vessel closure device to spontaneously take its functional
shape.
[0060] A vessel closure device made of a SMA, SMP, SMM or suitable
superelastic material can be compressed or restrained in its
delivery configuration on a delivery device using a sheath,
delivery shaft, or similar restraint, and then deployed to its
deployed configuration at a desired location by removal of closure
device from the shaft. A vessel closure device made of a thermally
sensitive material can be deployed by exposure of the closure
device to a sufficient temperature to facilitate expansion.
[0061] In still other embodiments, the closure device is comprised
at least partially of absorbent biomaterials. Suitable biomaterials
include, for example, lyophilized or air-dried submucosal tissue or
other extracellular matrix-derived tissue from warm-blooded
vertebrate. Such materials have a variety of characteristics,
including one or more of: biological remodeling, resistance to
infection, and high similarity to autogenous material. Examples of
such submucosal or other extracellular matrix-derived tissue is
described in U.S. Pat. Nos. 4,902,508, 5,281,422, 5,573,784,
5,573,821, 6,206,931, and 6,790,220, the disclosures of which are
herein expressly incorporated by reference.
[0062] A vessel closure device can include, for example, a coating
of biomaterial around a wire core as described herein. As such a
coating can have high similarity to autogenous material of the
patient, there can be a reduced risk that the patient will reject
the closure device or receive an infection. Moreover, biological
remodeling characteristics of matrix-derived biomaterials can
further foster regeneration of tissue around the closure device to
close the opening in the bodily vessel and thereby prevent excess
blood loss.
[0063] Returning now to FIG. 2A, one embodiment of vessel closure
system 5 includes a vessel locator 70 for properly aligning and
positioning vessel closure device 10 in opening 52. In one
embodiment, for example, vessel locator 70 is a bleed-back
device.
[0064] In the illustrated embodiment, vessel locator 70 is extended
through the deployment mechanism, including delivery shaft 30 and
deployment member 40. For instance, deployment member 30 may
include a channel therethrough in which a bleed-back device or
other suitable type of vessel locator 70 may be placed. Vessel
locator 70 then extends through channel 32. Moreover, in some
embodiments, vessel locator 70 may also extend through vessel
closure device 10. For instance, in the illustrated embodiment
where vessel closure device 10 is a helical coil, a void can be
created within vessel closure device 10 through which vessel
locator 70 extends. In light of the disclosure herein, it should be
appreciated, however, that other configurations of a vessel closure
device may allow for a vessel locator to extend therethrough,
including, for example, the creation of a channel through an
otherwise solid pin or connector. In still other embodiments, the
vessel locator does not extend through the closure device. For
instance, the closure device may be positioned adjacent the vessel
locator.
[0065] To determine location of opening 52, the medical personnel
operating closure system 5 can press locator 70 against vessel wall
51. Periodically, the medical personnel may move vessel locator 70
as they try to find opening 52. When vessel locator 70 is placed
directly over opening 52, the medical personnel can extend vessel
locator into the lumen 54 of bodily vessel 50. In exemplary
embodiments, such as where vessel locator 70 is a bleed-back
device, fluid in lumen 54 will flow into vessel locator 70, thereby
allowing the medical personnel to view the bodily fluid and
determine that vessel locator 70 has found opening 52.
[0066] Once vessel locator 70 has indicated that it is within
opening 52, thereby also signaling that closure system 5 is
properly positioned with respect to opening 52, vessel locator may,
optionally, then be removed from lumen 54 and/or the deployment
mechanism. Thereafter, vessel closure device 10 can be deployed
into opening 52 in any suitable manner. For instance, vessel
closure device 10 can be threaded into vessel walls 51 around
opening 52 to engage wall tissue 51 and pull it together to close
opening 52, as described herein, or installed in any other suitable
manner.
[0067] Upon installation of vessel closure device 10, the
deployment mechanism, including delivery shaft 30 and deployment
member 40, can be retracted from bodily vessel 54 and removed from
the incision in the patient. Prior to retraction and removal,
however, the deployment mechanism may be disengaged or otherwise
disconnected from vessel closure device 10. For instance, in the
illustrated embodiment, deployment member 40 includes retention
sleeve 42 in which the proximal tip of vessel closure device 10 is
received. As deployment member 40 rotates in a first direction
(e.g., counter-clockwise), deployment member 40 maintains its
connection with vessel closure device 10 and moves within delivery
shaft 30 towards vessel 50, such that the distal tip of vessel
closure device 10 enters vessel wall 51.
[0068] If, however, deployment member 40 is rotated in a second
direction (e.g., clockwise), deployment member 40 may translate
along channel 32 away from vessel 50, and may detach from vessel
closure device 10. In this manner, rotating deployment member in a
first direction engages and installs vessel closure device 10,
while rotation in a second direction detaches vessel closure device
10 from the deployment mechanism. Consequently, retention sleeve 42
is configured to temporarily and removably mount vessel closure
device 10 to deployment member 40.
[0069] The rotational direction of deployment member 40 can be
changed in any suitable manner. For example, medical personnel may
manually rotate deployment member 40. In some embodiments, a
ratchet mechanism, as is known in the art, may be used to
facilitate the change of direction and/or rotation of deployment
member 40. In addition, it should be appreciated, particularly in
light of the disclosure herein, that no particular rotational
direction or motion of deployment member 40 is limiting of the
present invention. For instance, deployment member 40 may be
rotated clockwise to install vessel closure device 10 and
counter-clockwise to detach vessel closure device 10 from the
deployment mechanism.
[0070] In other embodiments, vessel closure device 10 can be
detached without rotating deployment member 40. For instance, as
discussed herein, exemplary embodiments may include a clasp holding
vessel closure device 10 to deployment member 40 or a magnetic
field for mounting vessel closure device 10 to deployment member
40. In such embodiments, vessel closure device 10 may be detached
by releasing the clasp or removing a magnetic field (e.g., by
applying or removing an electrical charge or current).
[0071] Turning now to FIGS. 4 and 5, various alternative
embodiments of a spiral vessel closure device are illustrated. In
FIG. 4, for example, a vessel closure device 110 is illustrated
which has a beehive configuration or double tapered configuration.
In particular, as illustrated, vessel closure device 110 comprises
a wire 112 that is helically wound into a plurality of coils,
wherein the coils take a double-conical, beehive configuration.
[0072] For example, vessel closure device 110 can include a first,
proximal end 114 and a second distal end 116. Between proximal end
114 and distal end 116 is a medial portion 118. In the illustrated
embodiment, the width of the coils at proximal end 114 and distal
end 116 are less than the width of the coils at medial portion 118.
In this manner, the width of vessel closure device 110 can increase
between proximal end 114 and medial portion 118, and decrease
between medial portion 118 and distal end 116.
[0073] As should be appreciated, particularly in light of the
disclosure herein, vessel closure device 110 can be used to close
an opening in any bodily vessel. For example, vessel closure device
110 can be deformed and placed inside a deployment mechanism such
that in the closure system illustrated in FIG. 2A. In particular,
vessel closure device 110 can be inserted into a delivery shaft and
rotatably deployed using engagement of a proximal tip 115 with the
deployment mechanism, such that a distal tip 117 of a distal end
116 of vessel closure device 110 is pushed into a vessel wall.
Vessel closure device 110 can then be further rotated and threaded
into the vessel wall, around an opening therein, while the conical
configuration allows vessel closure device 110 to pull the vessel
wall together to thereby close off the vascular opening.
[0074] FIG. 5 illustrates yet another exemplary embodiment of a
spiral vessel closure device. In the illustrated embodiment, a
vessel closure device 210 can include a central post 212 around
which a plurality of threads 218 are wound in a spiral manner.
Optionally, at a proximal end 214 of vessel closure device 210, a
cap 211 can be affixed to central post 212. Cap 211 can be
configured to, for example, be temporarily and removably mounted to
a deployment member so as to be rotatably secured into the vessel
wall around an opening in a bodily vessel.
[0075] Vessel closure device 210 can also be inserted to close the
opening using a deployment mechanism similar to that illustrated in
FIG. 2A. For example, vessel closure device 210 can be inserted
into a delivery shaft while a deployment member engages cap 211
through cooperating structures, such as but not limited to, pins,
tips, channels, hole, etc., and rotates, thereby also rotating
vessel closure device 210 and translating it along the length of
the delivery shaft. Upon exiting the shaft, the plurality of
threads 218 engage the vessel wall around a vascular opening,
thereby securing vessel closure device 210 to the vessel and also
pulling the vessel wall together. Moreover, vessel closure device
210 can further act as a plug to not only pull the vessel wall
together, but to also block the flow of fluid from the lumen of the
bodily vessel.
[0076] In the illustrated embodiment, threads 218 are illustrated
as being tapered. In particular, the threads nearest distal end 216
are longer than the threads nearest proximal end 214. It will be
appreciated that such threads may be formed integrally with post
212, or may be separately formed. For instance, threads 218 may be
formed of a single wire that is affixed to post 212.
[0077] In another embodiment, threads 218 may not be tapered, such
that the diameter of each of threads 218 is equal. In still another
embodiment, threads 218 may be of equal length while vessel closure
device 210 is tapered. For instance, post 212 may be tapered while
threads 218 have the same length, thereby providing a spiraling
conical configuration having threads of the same length.
[0078] Turning now to FIG. 6, an alternative embodiment of a
deployment mechanism 320 is illustrated. In this embodiment,
deployment mechanism 320 includes a delivery shaft 330 and a mating
deployment member 340 for engaging a vessel closure device.
Delivery shaft 330 may include internal threads 332 on the internal
surface of the internal channel, while deployment member 340 has
corresponding external threads 342 on the outer surface.
[0079] By including mating threads 332 and 342, a user can quickly
and easily rotate deployment member 340 and also move deployment
member 340 along the axis of delivery shaft 330. In particular, as
deployment member 340 is rotated in one direction, threads 332, 342
cause deployment member 340 to translate and move along the axis of
delivery shaft 330 towards a bodily vessel and the distal end 334
of delivery shaft 330. Conversely, when deployment member 340 is
rotated in an opposing direction, threads 332, 342 cause deployment
member 330 to translate and move along the axis of delivery shaft
330 away from distal end 334.
[0080] While threads 332 on delivery shaft 330 are illustrated as
internal threads, and threads 342 on deployment member 340 are
illustrated as external threads, it will be appreciated that this
feature is exemplary only. In particular, threads of any type are
contemplated. For example, in light of the disclosure herein, it
should be appreciated that internal threads may be formed on the
outer surface of the deployment member and mating external threads
formed on the internal surface of delivery shaft 330.
[0081] In some embodiments, delivery shaft 330 may also include
internal secondary threads 336 for receiving a closure device.
Internal secondary threads may be used in addition to, or as an
alternative to threads 332. In particular, a spiral vessel closure
device, such as one having a plurality of threads or coils, can be
set within the internal threads on the internal surface of delivery
shaft 330. Thereafter, deployment member 330 can engage the closure
device and be rotated--with or without threading--to rotate and
translate the closure device into a vessel wall around a vascular
opening.
[0082] The present invention may be embodied in other specific
forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in
all respects only as illustrative and not restrictive. The scope of
the invention is, therefore, indicated by the appended claims
rather than by the foregoing description. All changes which come
within the meaning and range of equivalency of the claims are to be
embraced within their scope.
* * * * *