Surgery – Instruments – Surgical mesh – connector – clip – clamp or band
Reexamination Certificate
1998-12-16
2001-05-15
Truong, Kevin (Department: 3731)
Surgery
Instruments
Surgical mesh, connector, clip, clamp or band
C606S200000
Reexamination Certificate
active
06231581
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to implantable devices, and, in particular, to anchors that secure implantable medical devices.
Implantable medical devices, such as blood filters, stents, and grafts, are deployed within a body, for example, in a blood vessel, during both surgical and non-surgical medical procedures. An anchor secures the device in place by either piercing or pressing outwardly against the wall of the blood vessel. A physician compresses the medical device and inserts the device into the blood vessel. When the device expands, the anchor engages the wall of the blood vessel to secure the implantable medical device. In addition, other types of medical devices require anchoring within the body generally, such as valves, pacing leads, tethered devices that are removable, embolic devices, and infusion devices. A physician places such devices in, for example, blood vessels, intestines, other lumens, and other portions of the body.
For example, referring to
FIG. 1
, a prior art blood filter
10
resides within a lumen, for example, a blood vessel
12
. Filter
10
prevents clots in the blood from flowing within blood vessel
12
to other areas of the body located downstream of filter, especially the heart, lungs, and brain. Filter
10
is generally conical and has a set of six corrugated (or zig-zagged) arms
16
that extend from an apical end
17
. Arms
16
act in conjunction with each other to filter clots from the blood. Typically, filter
10
is compressed within a delivery sleeve (not shown) at the end of a catheter. A physician inserts the compressed filter
10
into a lumen such as blood vessel
12
. Once filter
10
is inside blood vessel
12
, the physician removes the delivery sleeve, and filter
10
expands. Arms
16
exert a radial force transverse to a central axis
24
of the filter
10
against a wall
22
of vessel
12
.
Each arm
16
has a corresponding end
18
that forms one of six hooks
14
a
-
14
f
. When filter
10
expands into the position shown in
FIG. 1
, hooks
14
a
-
14
f
engage with wall
22
, preventing filter
10
from migrating within blood vessel
12
, for example, the vena cava. Each hook
14
a
-
14
f
terminates at a corresponding point
20
. The radial force of arms
16
causes points
20
to pierce wall
22
. Hooks
14
a
,
14
c
,
14
d
, and
14
f
each have a corresponding point
20
oriented in the direction of blood flow. Thus, hooks
14
a
,
14
c
,
14
d
, and
14
f
counteract the force of the blood rushing through filter
10
and prevent the migration of filter
10
within blood vessel
12
. In addition, hooks
14
b
and
14
e
each have corresponding points
20
that are oriented in the direction opposite the blood-flow. Thus, hooks
14
b
and
14
e
prevent migration of filter in the direction opposite the blood flow, which may be caused, for example, by movement of the body.
Referring to
FIGS. 2 and 3
, another type of prior art blood clot filter
32
includes a wire mesh
34
. Wire mesh
34
has a cylindrical portion
36
and a conical portion
38
. Conical portion
38
extends from an apical end
40
. An opposite end
44
of filter
32
includes an opening
46
that allows blood and clots to flow into filter
32
. Filter
32
is described in greater detail in U.S. patent application Ser. No. 09/008,258, the entire disclosure of which is incorporated herein by reference.
Filter
32
also includes anchors
30
. Anchors
30
include two separate pieces: a shank
26
, which defines a hollow
28
, and a hook
29
, which is a metallic strip centered within hollow
28
. Anchors
30
attach to wire strands
42
at junctures
48
where wire strands
42
intersect. Hook
29
, and two wire strands
42
, extend through hollow
28
. Shank
26
, hook
29
, and wire strands
42
are welded together.
An implantable medical device, such as filter
10
or filter
32
, typically must be compressible to a diameter smaller than the diameter of the body lumen in which it is to be implanted. The compressed diameter of the device thus limits its use. Anchoring devices, such as hooks
14
a
-
14
f
or anchors
30
, have profiles that limit the contraction of a blood filter or other medical device.
SUMMARY OF THE INVENTION
In one aspect, the invention provides a low profile anchor adapted to secure an implantable device within a body by engaging the wall of the body. The anchor includes a shank and at least one arm that extends from the shank. The shank and the arm are integrally formed from a single member. The shank is adapted for attachment to a device, and the first arm is adapted for engaging the wall of the body when the device is implanted within a body.
Embodiments of this aspect of the invention may include one or more of the following features. The anchor has two arms, and each arm extends from a corresponding opposite end of the shank. The arms extend in opposing directions relative to a longitudinal axis.
The shank and the arms are integrally formed from flat stock. The shank may be an elongated section disposed at an angle to both the first arm and the second arm. At least a portion of the shank is curled about the axis to form a loop. Alternatively, the shank may have several different embodiments. The shank may be a single strip curled about the axis to form a plurality of loops that are adjacent to one another. The shank may be curled about the axis until one edge of the shank is oriented in substantially the same direction as an opposite edge of the shank. The shank may include tab sections that extend from opposite edges of the shank and that are curled about the axis. The shank may extend along the axis at an angle to two arms, which are respective openings aligned along the axis, and the shank may include a slot that extends between and connects the openings. The shank may be a hollow tube with a cylindrical shape, elliptical shape, or a pair of lobes.
Similarly, the arms may have several different embodiments. The arms of the anchor may extend at an angle relative to the axis or may parallel the axis. The arms may be curved. The arms may include one or more bends. The arms may include a pointed end, a rounded end, or a flat end. The arms may include sharp or dull edges. The arms may be resilient.
The anchor may be constructed of shape memory material, stainless steel, or titanium. The anchor may be attached to an implantable device, such as blood clot filters, grafts, stents, valves, pacing leads, tethered devices that are removable, embolic devices, and infusion devices.
In another aspect, the invention provides a process for making an anchor for securing an implantable device in a body. The process includes the steps of forming flat stock into a member having a shank section and at least one arm section, and bending the shank section about an axis. The process may additionally include configuring the arm sections by shaping, angling, curving, bending, twisting, sharpening, or dulling the arm sections.
In still another aspect, the invention provides a process for making an anchor for securing an implantable device in a body. The process includes the steps of forming a member into a shape having a shank section and at least one arm section, and providing a hollow within the shank section. The process may additionally include configuring the arm sections by shaping, angling, curving, bending, twisting, sharpening, or dulling the arm sections.
Embodiments of the invention may have one or more of the following advantages. Anchors according to the invention allow an implantable device, such as a blood clot filter, to be compressed to a relatively small profile and be inserted into a relatively small lumen. The anchor may be small relative to the lumen or the implantable device. The anchor is formed from a single piece of material. The anchor can be produced efficiently. The arms of the anchor may be resilient. The arms may contract to reduce the profile of the anchor during insertion. The arms may expand to engage the walls of a lumen. An anchor configured with a single arm can provide a preferred engageme
Heath Kevin R.
Shank Peter J.
Shapiro Gary M.
Shukhat Victor J.
Takeuchi Makoto
Boston Scientific Corporation
Hoffmann & Baron , LLP
Truong Kevin
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