U.S. patent application number 09/981736 was filed with the patent office on 2002-03-07 for alignment member for delivering a non-symmetrical device with a predefined orientation.
This patent application is currently assigned to AGA Medical Corp.. Invention is credited to Afremov, Michael, Amplatz, Kurt.
Application Number | 20020029061 09/981736 |
Document ID | / |
Family ID | 24288762 |
Filed Date | 2002-03-07 |
United States Patent
Application |
20020029061 |
Kind Code |
A1 |
Amplatz, Kurt ; et
al. |
March 7, 2002 |
Alignment member for delivering a non-symmetrical device with a
predefined orientation
Abstract
A device and method for delivering an object within a patient,
wherein the object is delivered in a preferred orientation relative
to the delivery site of the patient. The delivery device has an
alignment member that allows the object to be delivered
intravascularly to the delivery site of the patient, wherein the
object is delivered in a pre-determined orientation. The object
may, for example, be non-symmetric or include a configuration that
requires delivery to the site in only one suitable orientation
relative to the delivery site. Such objects may be used, for
example, to treat certain defects or injuries in vessels or organs
within a patient's body.
Inventors: |
Amplatz, Kurt; (St. Paul,
MN) ; Afremov, Michael; (St. Louis Park, MN) |
Correspondence
Address: |
NIKOLAI MERSEREAU & DIETZ, P.A.
820 INTERNATIONAL CENTRE
900 SECOND AVENUE SOUTH
MINNEAPOLIS
MN
55402
|
Assignee: |
AGA Medical Corp.
682 Mendelssohn Avenue
Golden Valley
MN
55427
|
Family ID: |
24288762 |
Appl. No.: |
09/981736 |
Filed: |
October 17, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
09981736 |
Oct 17, 2001 |
|
|
|
09572649 |
May 17, 2000 |
|
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Current U.S.
Class: |
606/190 |
Current CPC
Class: |
A61B 17/12109 20130101;
A61B 2017/12095 20130101; A61B 2017/00606 20130101; A61B 2017/00592
20130101; A61B 17/12172 20130101; A61B 2017/00623 20130101; A61B
17/12022 20130101; A61B 2017/00455 20130101 |
Class at
Publication: |
606/190 |
International
Class: |
A61B 017/00 |
Claims
What is claimed is:
1. A delivery device suitable for delivering a collapsible device
to a preselected region within a patient, said delivery device
comprising: an elongated pusher catheter having a proximal end and
a distal end, said distal end includes a distal tip having an
alignment member adapted for mating with a connecting member of the
collapsible device, wherein the orientation of the alignment member
relative to a longitudinal axis of the elongated pusher catheter is
predetermined.
2. The delivery device as recited in claim 1, wherein said pusher
catheter includes a lumen extending through the elongated pusher
catheter between the proximal end and distal end, and wherein said
distal tip includes an aperture extending there through and aligned
with said lumen.
3. The delivery device as recited in claim 2, further including a
cable extending through the lumen of said pusher catheter, wherein
a distal end of said cable is extendable through the aperture of
the distal tip and coupleable to the collapsible device.
4. The delivery device as recited in claim 3, wherein the distal
end of said cable includes a threaded outer surface.
5. The delivery device as recited in claim 1, wherein said
alignment member has a semicircular shape.
6. The delivery device as recited in claim 1, wherein the
orientation of the connecting member of the collapsible device
relative to a shape of the collapsible device is preset.
7. The delivery device as recited in claim 1, wherein the mating
between the alignment member and connecting member inhibits the
collapsible device from rotating about the distal tip.
8. A delivery device suitable for delivering a collapsible device
to a preselected region within a patient, said delivery device
comprising: an elongated pusher catheter having a proximal end and
a distal end, said distal end includes a distal tip having means
for aligning a connecting member of the collapsible device in a
predetermined orientation relative to the distal tip, said distal
tip further including means for mating the distal tip with said
connecting member, wherein the predetermined orientation relative
to the distal tip is further set relative to a bend fixed in the
pusher catheter.
9. The delivery device as recited in claim 8, wherein said pusher
catheter includes a lumen extending through the elongated pusher
catheter between the proximal end and distal end, and wherein said
distal tip includes an aperture extending therethrough and aligned
with said lumen.
10. The delivery device as recited in claim 9, further including a
cable extending through the lumen of said pusher catheter, wherein
a distal end of said cable is extendable through the aperture of
the distal tip and coupleable to the collapsible device.
11. The delivery device as recited in claim 10, wherein the distal
end of said cable includes a threaded outer surface.
12. The delivery device as recited in claim 8, wherein said means
for aligning includes a semicircular shape.
13. The delivery device as recited in claim 8, wherein the
orientation of the connecting member of the collapsible device
relative to a shape of the collapsible device is preset.
14. The delivery device as recited in claim 8, wherein mating
between the means for aligning and the connecting member inhibits
the collapsible device from rotating about the distal tip.
15. A method for delivering a non-symmetric device within a
patient, wherein the orientation of the device is predefined, said
method comprising the steps of: a. coupling a non-symmetric device
to an elongated pusher catheter having a proximal end and a distal
end, said distal end including a distal tip having an alignment
member adapted for mating with a connecting member of the
non-symmetric device, wherein the orientation of the alignment
member relative to a bend fixed in the pusher catheter is preset;
b. positioning a sheath within the patient's body vessel, wherein a
distal end of said sheath is proximate a desired site of delivery,
said sheath having a bend fixed therein corresponding to a shape of
the vessel proximate the desired site of delivery; c. loading said
non-symmetric device and said pusher catheter into a sheath by
connecting said alignment member which is relative to a curve in
said pusher catheter; d. delivering said non-symmetric device to
the desired site.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to the delivery of
an object within a patient, wherein the object is delivered in a
preferred orientation relative to the delivery site of the patient.
More particularly, the present invention relates to a delivery
device having an alignment member that allows the object to be
delivered intravascularly to the delivery site of the patient,
wherein the object is delivered in a pre-determined orientation.
The object may, for example, be non-symmetric or include a
configuration that requires delivery to the site in only one
suitable orientation relative to the delivery site. Such objects
may be used, for example, to treat certain defects or injuries in
vessels or organs within a patient's body.
BACKGROUND OF THE INVENTION
[0002] Over the years, medical devices delivered intravascularly
have been used to treat many types of defects in the tissues and
organs of a patient. For example, intra cardiac devices have been
used to treat certain congenital defects of the heart including a
ventricular septal defect (VSD--a defect or aperture extending
through the septum between the left and right ventricles), atrial
septal defect (ASD--a defect or aperture extending through the
septum between the right and left atrium) or patent ductus
arteriosus (PDA--an incomplete closure of an opening between the
pulmonary artery and the aorta that is present during fetal
development). These conditions may cause blood to abnormally shunt
between the heart chambers causing an imbalance in the oxygen
levels in the blood causing cyanosis, cardiac enlargement, failure
or other complications.
[0003] Non-invasive techniques have been developed to treat these
defects. These techniques include the use of catheters and guide
wires to deliver an occluding device to the desired location within
the patient's heart. These devices may be difficult to position and
a non-symmetric device may prove to be even further challenging to
deliver in a preferred orientation. For example, a PDA device may
preferably be shaped non-symmetrically to conform to the angle of
the communication between the main pulmonary artery and the aorta.
In order for this non-symmetric device to be effective, it must be
delivered in the communication with a specific orientation so that
the retention disc of the device is flush against the aorta wall.
As another example, perimembranous ventricular septal defects are
typically very close to the aortic valve. For closure of such
defects, the retention mechanism must be asymmetrical wherein the
retention disc is offset from the center of the device, such that
the retention disc extends further out from the main portion on one
side than on the other side of the main portion. The smaller
portion of the retention disc or rim is oriented toward the aortic
valve.
[0004] Other defects in blood vessels, for example, may require the
delivery of a device into the vessel, wherein a particular
orientation of the device within the vessel is required. For
example, the device may include an aperture or some other
particular configuration requiring delivery of the device in a
particular orientation in the vessel. Hence, there is a need for a
device and method of delivering an object to a specific site,
wherein the orientation of the object is controlled. The present
invention meets these and other needs that should be apparent to
those skilled in the art.
SUMMARY OF THE INVENTION
[0005] The device of the present invention is suitable for
delivering a collapsible object to a pre-selected region within a
patient. An elongated pusher catheter, for example, may be modified
to include on its distal end a distal tip having an alignment
member adapted for mating with a connecting member of the
collapsible object. The elongated pusher catheter may further have
a preset curve or bend designed to match the shape or curve of the
delivery sheath which roughly matches the shape or curve of the
vessel adjacent the delivery site. During delivery of the elongated
pusher catheter, the catheter tends to rotate so that the bend in
the catheter tends towards alignment with the curve in the vessel.
When the collapsible object is attached in a fixed position to the
distal tip of the elongated pusher catheter, the orientation of the
collapsible object is known relative to the bend in the pusher
catheter. In this manner, when the elongated pusher catheter is
delivered, the orientation of the collapsible object is known
relative to the curve of the delivery catheter and the vessel at
the delivery site. Correct orientation can be accomplished by
incorporating the same curvature in the pusher catheter and the
delivery catheter or by preventing rotation of the delivery pusher
in the delivery catheter.
[0006] In the preferred embodiment the pusher catheter includes a
lumen extending there through between the proximal end and distal
end, wherein the distal tip includes an aperture extending there
through and aligned with the lumen. A cable extends through the
lumen of the pusher catheter, wherein a distal end of the cable is
extendable through the aperture of the distal tip and coupleable to
the collapsible object. Without limitation, the distal end of the
cable includes a threaded outer surface and the collapsible object
includes a member having a threaded bore adapted for receiving the
threaded outer surface of the cable. Those skilled in the art will
appreciate that other methods of releaseably fastening objects
together may be incorporated into the distal tip and collapsible
object without imparting from the present invention.
[0007] The distal tip of the pusher catheter further includes an
alignment member having a predetermined shape. The coupling member
of the collapsible object includes a corresponding mating shape,
such that the collapsible object may only align and engage the
alignment member in one orientation. For example, without
limitation, the shape of the alignment member may be a
semicircular, a square with one beveled corner, an isosceles
triangle, or other shape that only allows for one mating
orientation. The engagement between the alignment member and
connecting or coupling member inhibits the collapsible device from
rotating about the distal tip.
[0008] In use, a non-symmetric object may be delivered within a
patient utilizing the device of the present invention, wherein the
orientation of the object is predefined. The user first couples the
non-symmetric device to an elongated pusher catheter, wherein the
distal tip has an alignment member adapted for mating with a
connecting member of the non-symmetric device. The device may
include a radiopaque marker attached at a predefined position on
the asymmetrical device. In this manner, the orientation of the
asymmetrical device may be determined through fluoroscopy or
another known manner of observation. The orientation of the
alignment member is fixed relative to a bend in the pusher
catheter. A delivery sheath is then positioned within the patient's
body vessel, wherein a distal end of the sheath is proximate a
desired site of delivery. The sheath may also have a preset bend
corresponding to a shape of the vessel proximate the desired site
of delivery. Alternatively, the pusher catheter and interior lumen
of the sheath may be shaped to prevent rotation of the pusher
catheter within the sheath. The user then loads the non-symmetric
device coupled to the pusher catheter into the sheath, by
connecting the alignment member in an orientation associated with
the curve in the pusher catheter. The pusher catheter is then
passed through the sheath until the distal tip of the pusher
catheter extends out the sheath. The user may then determine
whether the collapsible object has been positioned properly and if
desired may disengage the object from the alignment member and tip
of the pusher catheter. The user may then remove the pusher
catheter and sheath in a known suitable fashion.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a perspective view of the elongated pusher
catheter of the present invention;
[0010] FIG. 2 is a perspective view of the elongated pusher
catheter of the type shown in FIG. 1 with a PDA device attached to
the distal tip;
[0011] FIG. 3 is side elevational view of the PDA device of the
type shown in FIG. 2;
[0012] FIG. 4 is a partial sectional side elevational view showing
a non-symmetric PDA device being delivered and conforming to the
angle of the communication between the main pulmonary artery and
the aorta.
[0013] FIG. 5 is a fragmented perspective view of the distal tip of
the elongated pusher catheter;
[0014] FIG. 6 is a top elevational view of the connecting member of
the PDA device shown in FIG. 2;
[0015] FIG. 7 is a fragmented perspective view of an alternate
embodiment of the distal tip of the elongated pusher catheter;
[0016] FIG. 8 is a top elevational view of an alternate embodiment
of the connecting member of the PDA device shown in FIG. 2;
[0017] FIG. 9 is a sectional view of a pusher catheter;
[0018] FIG. 10 is a sectional view showing a shape of the interior
lumen of a sheath adapted for receiving a pusher catheter having a
shape of the type shown in FIG. 9; and
[0019] FIG. 11 is a partial sectional side elevational view showing
an asymmetrical occluding device positioned in a perimembranous
ventricular septal defect.
DETAILED DESCRIPTION
[0020] The following detailed description of the preferred
embodiment in conjunction with the accompanying claims and drawings
describes the invention in which like numerals in the several views
refer to corresponding parts. The present invention represents
broadly applicable improvements to a delivery device and methods of
delivering an object within a patient in a predetermined
orientation. The embodiments detailed herein are intended to be
taken as representative or exemplary of those in which the
improvements of the invention may be incorporated and are not
intended to be limiting.
[0021] The present invention provides an elongated pusher catheter
10 deliverable through a sheath 12 and adaptable for coupling a
self-expanding object 14 thereto in a predetermined orientation.
Without limitation, the self-expanding object 14 has a shape
suitable for occluding a PDA, however, those skilled in the art
will appreciate that the self-expanding object may be provided in
several varying shapes and sizes. For example, the self-expanding
object 14 may be configured to be particularly well suited for
treating an ASD, VSD, PFO, a triple A graft for the repair of an
abdominal aortic aneurysm, or other defect wherein the shape and
orientation of the self-expanding object is significant.
[0022] Without any limitation intended, the self-expanding object
14 is preferably made from a tubular metal fabric including a
plurality of woven metal strands. A clamp 16 is attached to each
outer end of metal fabric, thereby inhibiting unraveling of the
metal fabric. At least one of the clamps 24 is adapted for coupling
to the end of the pusher catheter 10 for delivery to a preselected
site within the patient, as described below in greater detail.
[0023] Once the appropriate self-expanding object 14 has been
selected to treat the physiologic condition of the patient, a
catheter or other suitable delivery device may be positioned within
a channel in a patient's body to place the distal end of the
delivery device 10 adjacent the desired treatment site. The
delivery device 10 can be used to urge the self-expanding object
through the lumen of a sheath or other tube for deployment in a
patient's body. When the object is deployed out the distal end of
the sheath, the object remains attached to the end of the delivery
device. Once it is confirmed that the self-expanding object is
properly positioned within the patient, the pusher catheter 10 can
be detached from the self-expanding object 14 and then withdrawn.
By keeping the self-expanding object 14 attached to the pusher
catheter, the operator can retract the object 14 for repositioning,
even after deployment out the end of the pusher catheter 10, if it
is determined that the object is not properly positioned.
[0024] In a preferred embodiment shown in the Figures, the
non-symmetric medical occluding self-expanding object 14 is shown
attached to the pusher catheter or delivery catheter 10. The pusher
catheter 10 generally includes an elongated, flexible,
biocompatible tube having a lumen extending along the longitudinal
axis. A guide wire or cable may be positioned within the lumen of
the pusher catheter, and extends through the tip of the pusher
catheter. The tip of the cable is threaded and screws into the end
of the clamp, thereby securing the self-expanding object 14 to the
pusher catheter 10. The diameter of the lumen within the pusher
catheter 10 is dimensioned so that the guide wire may be rotated
inside of the pusher catheter 10, yet snug enough to avoid kinking
in the cable. The alignment member formed on the tip or distal end
of the pusher catheter includes a predetermined shape that mates
with a shape formed in the clamp, wherein the alignment member only
engages with the clamp in one orientation.
[0025] The pusher catheter 10 is curved near its distal tip. The
shape of the curve is dependent upon where the particular device is
designed to be delivered intravascularly. For example, if the
pusher catheter is intended to deliver an occluding device adjacent
a PDA, then the curve of the pusher catheter is shaped to
approximate the path between the pulmonary artery and communication
adjacent the aorta. As will be described below in greater detail,
the orientation of the shape fixed within the distal tip may be
controlled to thereby affect the orientation of the self-expanding
object attached to the alignment member. The curvature of the
pusher catheter contributes to the ability of the alignment member
to deliver the device in a predefined orientation.
[0026] Referring now to the Figures, the pusher catheter 10 of the
present invention is shown generally in FIGS. 1 and 2. The pusher
catheter 10 includes an elongated tubular segment 18 having a
proximal and distal end 28 and 30 respectively. A cable 20 extends
through the lumen of the tubular segment 18. The distal end 30 of
the tubular segment 18 includes an alignment member 24 fixed to the
distal end 30 of the tube 18. The alignment member 24 includes an
aperture 26 extending there through, wherein the center of the
aperture 26 generally aligns with the center of the lumen. The
distal end of the cable 20 is threaded and the distal end of the
cable extends out the distal end 30 of the tubular segment 18
through the aperture 26 in the alignment member 24. A handle 22 is
attached to the proximal end of the cable and assists in the
rotation of the cable inside the lumen of the tubular segment
18.
[0027] FIGS. 2 and 4 show a self-expanding object 14 attached to
the pusher catheter 10. The self-expanding object 14 includes a
connecting member or clamp 16 that attaches to the alignment member
24 (see FIG. 3). In order to adequately occlude the communication
between the aorta and pulmonary artery, the object 14 shown in FIG.
3 and 4 only has one preferable orientation. The flange, rim or
retention disc 32 extends at an acute angle from the main
cylindrical portion of the PDA device. In this manner, when the
flange 32 rests against the aorta wall, the main cylindrical
portion 34 extends into the communication at an angle relative to
the longitudinal axis of the aorta proximate the PDA. The
non-symmetric object 14 may include a radiopaque marker 44 attached
at a predefined position on the asymmetrical device 14. In this
manner, the orientation of the asymmetrical device 14 may be
determined through fluoroscopy or another known manner of
observation.
[0028] Referring now to FIGS. 5 and 6, the mating shape of the
alignment member 24 and clamp or connecting member 16 is shown. The
alignment member 24 includes a protrusion 36 having a semicircular
shape on one end of the protrusion 36. The clamp 16 includes a
corresponding shape forming a recess 38 formed in the clamp. The
protrusion 36 fits within the recess 38 and the distal end of the
cable 20 screws into a threaded bore 40 formed in the clamp 16.
Alternatively, the protrusion 36 may extend from the clamp 16 and
the recess 38 may be formed in the alignment member, as shown in
FIGS. 7 and 8. In this manner, the self expanding object 14 may
only be attached to the alignment member 24 with one orientation
relative to the pusher catheter 10 and, for example, markings 42 on
the proximal end of the tube segment 18. Thus, when the object 14
is delivered through the sheath, the orientation of the attached
object 14 is known relative to the markings 42. The delivery sheath
12 (see FIG. 4) is positioned within the patient's body vessel,
wherein a distal end of the sheath 12 is proximate a desired site
of delivery. The sheath 12 may also have a preset bend
corresponding to the bend in the pusher catheter 10. Alternatively,
the pusher catheter 10 and interior lumen 60 of the sheath 12 may
be shaped to prevent rotation of the pusher catheter 10 within the
sheath 12 (see FIGS. 9 and 10).
[0029] FIG. 11 shows an occluding object 46 positioned to occlude a
perimembranous ventricular septal defect in the septum 48. The
occluding device 46 is asymmetrical and includes flanges 50 and 52
that engage against the septum 48 and surround the defect. A
radiopaque marker 44 is shown attached to flange 50. In this
manner, when the occluding device 46 is delivered, the proper
positioning of the device 46 may be confirmed. The connecting
member 16 mates with the alignment member 24 of the pusher catheter
10. As shown in FIG. 11, the alignment member 24 and connecting
member 16 allows for delivery of an asymmetrical device 46 in a
preferable orientation, with the longer portion of the flange 52
engaging the septum away from the aortic valve.
[0030] This invention has been described herein in considerable
detail in order to comply with the patent statutes and to provide
those skilled in the art with the information needed to apply the
novel principles and to construct and use embodiments of the
invention as required. However, it is to be understood that the
invention can be carried out by specifically different devices and
that various modifications can be accomplished without departing
from the scope of the invention itself.
* * * * *