U.S. patent application number 13/165673 was filed with the patent office on 2012-02-02 for sealing device and delivery system.
Invention is credited to Steven J. Masters.
Application Number | 20120029556 13/165673 |
Document ID | / |
Family ID | 45527498 |
Filed Date | 2012-02-02 |
United States Patent
Application |
20120029556 |
Kind Code |
A1 |
Masters; Steven J. |
February 2, 2012 |
SEALING DEVICE AND DELIVERY SYSTEM
Abstract
The invention relates to a sealing device for repair of cardiac
and vascular defects or tissue opening such as a patent foramen
ovale (PFO) or shunt in the heart, the vascular system, etc. and
particularly provides an occluder device and trans-catheter
occluder delivery system. The sealing device would have improved
conformity to heart anatomy and be easily deployed, repositioned,
and retrieved at the opening site.
Inventors: |
Masters; Steven J.;
(Flagstaff, AZ) |
Family ID: |
45527498 |
Appl. No.: |
13/165673 |
Filed: |
June 21, 2011 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
12498586 |
Jul 7, 2009 |
|
|
|
13165673 |
|
|
|
|
61219120 |
Jun 22, 2009 |
|
|
|
Current U.S.
Class: |
606/213 |
Current CPC
Class: |
A61B 2017/00597
20130101; A61B 2017/00592 20130101; A61B 2017/00623 20130101; A61B
2017/00867 20130101; A61B 17/0057 20130101; A61B 2017/00526
20130101; A61B 90/39 20160201; A61B 2017/00606 20130101; A61B
2017/00575 20130101 |
Class at
Publication: |
606/213 |
International
Class: |
A61B 17/03 20060101
A61B017/03 |
Claims
1. A medical device comprising: a first eyelet and a second eyelet
defining a longitudinal axis; a plurality of wires starting at the
first eyelet and ending at the second eyelet; each wire forming a
closed teardrop shape the teardrop shape defining an internal area;
wherein the teardrop shape of the wires combine to create an inner
peripheral edge and each wire combining to create an outer
peripheral edge.
2. A medical device comprising: a deployed configuration and a
delivery configuration with an eyelets located at each opposing end
of the device, each eyelet having an inner end and an outer end
wherein the inner ends are nearer the middle of the device; a
longitudinal axis extending through both eyelets; at least three
wires having opposing ends that are helically wound together to
form the eyelets wherein when viewed from on end in a direction
parallel to the longitudinal axis, a middle length portion of each
wire is bent into a teardrop shape having a pointed end; and
wherein the bent wire progresses away from the pointed end of the
teardrop bending at a larger radius than that of the teardrop shape
back to converge with the inner end of each eyelet.
3. A medical device comprising: at least three wires having
opposing ends helically wound together to form two eyelets; the two
eyelets located at a proximal and distal end of the device; and
wherein each wire diverges tangentially away from the eyelet with
all wires spaced apart in approximately equal radial amounts; and
wherein each wire continues outward and bends gradually in the same
direction for about 180.degree. to form an outer diameter of the
device and bends inwardly toward the center line of the device with
a smaller radius until it again converges with the outer diameter
of the device bending inwardly at he larger radius until it reaches
the inner end of the proximal eyelet where the proximal ends of all
the wires are helically wound together to form the proximal end of
the device.
4. A medical device comprising: a deployed configuration and a
delivery configuration, a proximal end and a distal end; at least
three wires which form two eyelets, one at the proximal end and one
at the distal end; and wherein while in the deployed configuration
at least one of the wires assumes a reniform shape.
5. A medical device comprising: a deployed configuration and a
delivery configuration, a proximal end and a distal end; at least
three wires which form two eyelets, one at the proximal end and one
at the distal end and a longitudinal axis extending through the
eyelets; and wherein while in the deployed configuration at least
one of the wires forms a teardrop shape as viewed from one end
along the longitudinal axis of the device.
6. A septal occluder device comprising: a plurality of wire forms
wherein each wire form starts and stops at an eyelet; each of the
wire forms having an internal radial surface and an external radial
surface.
7. A defect closure device comprising a shape having a wire frame
including opposing ends having a larger diameter and a middle
region with a smaller diameter, wherein the middle region
substantially fully occupies the defect without appreciably
enlarging the defect.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a Continuation in Part of U.S. patent
application Ser. No. 12/498,586, filed Jul. 7, 2009, which claims
priority to provisional application U.S. Ser. No. 61/219,120, filed
Jun. 22, 2009.
FIELD OF THE INVENTION
[0002] The Invention relates to a sealing device for repair of
cardiac and vascular defects or tissue opening such as a patent
foramen ovale (PFO) or shunt in the heart, the vascular system,
etc. and particularly provides an occluder device and
trans-catheter occluder delivery system.
BACKGROUND OF THE INVENTION
[0003] Sealing devices may be utilized for the occlusion of many
types of tissue openings, such as septal defects, PFO, and the
like.
[0004] Tissue openings have traditionally been corrected by
open-heart surgery. In order to avoid the trauma and complications
associated with open-heart surgery, a variety of trans-catheter
closure techniques have been implemented. In such techniques, an
occluding device is delivered through a catheter to the site of the
opening or defect. A device is placed into the defect and
permanently deployed.
[0005] A variety of trans-catheter delivered devices are known.
These include devices that require assembly at the site of the
tissue opening or require threading or "buttoning" of the discrete
device elements. Other devices include self-expanding devices.
These self-expanding devices tend to be difficult to visualize,
cumbersome to load, difficult to position at the site of a tissue
opening, and reposition. Most self-expanding devices do not conform
to heart anatomy leading to tissue erosion.
[0006] An example of a self-expanding device includes an occlusion
bag, a third tube, a guide catheter, a super elastic wire, a
release mechanism and a delivery sheath. The super elastic wire is
attached to the release mechanism and the wire, release mechanism,
occlusion bag, guide catheter and third tube are inserted into a
delivery sheath for transport to the aperture. After delivery, the
occlusion bag is placed within the aperture and the wire is
deployed within the bag. The bag and wire are repositioned if
necessary, and the release mechanism is activated to release the
wire.
[0007] Another example of a self-expanding device includes a shape
set tubular metal fabric device and optionally, an occluding fiber
included in the hollow portions of the device. The metal fabric
defines a medical device shaped like a bell, which can be collapsed
for passage through a catheter for deployment in a channel of a
patient's body.
[0008] While these and other self-expanding devices are designed
for trans-catheter delivery, they require assembly either prior to
use or during use. They are also difficult to reposition or
retrieve once deployed and provide poor conformity to heart
anatomy. For these reasons, it would be desirable to provide an
improved sealing device for use in trans-catheter techniques. Such
sealing devices would preferably have improved conformity to heart
anatomy and be easily deployed, repositioned, and retrieved at the
opening site.
[0009] Trans-catheter self-expanding sealing devices may be
delivered and deployed by a variety of means. Most trans-catheter
delivery devices choose one of two basic systems for deploying the
device: pulling back an outer catheter to release the device or
pushing the device free of the catheter with a push rod. Each of
these systems utilizes a handle to actuate the mechanism used to
deploy the device. An example of such a system includes a flexible
urging member for urging the sealing device through a catheter and
a remotely located control means for advancing the urging member.
In this example, the control means includes a threaded, tubular
shaft connected to the urging member and a manually rotatable
threaded rotor mounted on the shaft. The threads on the rotor mate
with the threads on the shaft so that the rotation of the rotor
through a known angle will advance the shaft and the urging member
a known distance.
[0010] An example of a system that utilizes a pull back outer shaft
or catheter includes a handle that may selectively hold the
delivery system components at any configuration during deployment
and positioning of the device. The outer catheter of such a system
would be pulled back to release the device by actuating a sliding
lever and a rotating finger ring on the delivery system handle.
[0011] While these and other device delivery systems are designed
for trans-catheter device deployment, they require the use of a
threaded rotor, which can become difficult to rotate or they
require large forces to pull back the outer catheter to expose the
entire length of the constrained device. Most deployment systems
are either not reversible or very difficult to reverse once the
deployment procedure has taken place. For these reasons, it would
be desirable to provide an improved delivery system for a sealing
device. Such delivery system would preferably have a handle able to
be operated simply with a single hand and would be able to execute
multiple manipulations with minimal force or hand movement.
SUMMARY OF THE INVENTION
[0012] A first embodiment provides a sealing device having an
expandable frame formed from a plurality of wires extending from a
proximal end to a distal end of the frame with the wires forming a
proximal and distal eyelet with a sealing member at least partially
encapsulating the expandable wire frame.
[0013] A further embodiment provides a handle for deploying a
sealing device having a housing having a slot and a length with a
linear actuator located within the slot and the linear actuator
capable of independently advancing and retracting at least three
separate components by advancing and retracting the actuator along
the slot length.
[0014] An additional embodiment provides an apparatus comprising a
handle having a housing having a slot with a length and a linear
actuator located within the slot the linear actuator capable of
independently advancing and retracting at least three separate
components by advancing and retracting the actuator along the slot
length. The apparatus also comprising a sealing device having an
expandable frame formed from a plurality of wires extending from a
proximal end to a distal end of the frame with the wires forming a
proximal and distal eyelet with a sealing member at least partially
encapsulating the expandable wire frame.
[0015] Additional features and advantages of the invention will be
set forth in the description or may be learned by practice of the
invention. These features and other advantages of the invention
will be realized and attained by the structure particularly pointed
out in the written description and claims hereof as well as the
appended drawings.
[0016] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory and are intended to provide further explanation of
the invention as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The accompanying drawings are included to provide a further
understanding of the invention and are incorporated in and
constitute a part of this specification, illustrate embodiments of
the invention, and together with the description serve to explain
the principles of the invention.
[0018] In the drawings:
[0019] FIG. 1 is a perspective view of a deployed sealing device
attached to the distal end of a delivery system.
[0020] FIG. 2A is a view of an expanded frame of a sealing
device.
[0021] FIG. 2B is an end on view of an eyelet of a sealing
device.
[0022] FIG. 2C is a end on view of a frame of a sealing device.
[0023] FIGS. 3A-B are views of components of a winding jig.
[0024] FIG. 4A is a side view of a winding jig.
[0025] FIG. 4B is a top view of a winding jig.
[0026] FIG. 5A is a side view of an expanded covered sealing
device.
[0027] FIG. 5B is a side view of an expanded partially covered
sealing device.
[0028] FIG. 6 is a side view of a self-centering embodiment of a
sealing device.
[0029] FIG. 7 is a side view of a deployed sealing device.
[0030] FIG. 8 is a perspective view of a delivery system including
a deployment handle and attached sealing device.
[0031] FIG. 9A-D are flow charts describing the operation of the
delivery system.
[0032] FIG. 10 is a perspective view of a sealing device deployment
handle.
[0033] FIG. 11 is a perspective view of an assembly of a sealing
device deployment handle.
[0034] FIG. 12A is a top down view of an embodiment of a first
linear actuator.
[0035] FIG. 12B is a side view of an embodiment of a first linear
actuator.
[0036] FIG. 12C is a side view of an embodiment of a first linear
actuator.
[0037] FIG. 12D is a side view of an embodiment of a first linear
actuator.
[0038] FIG. 13A is a perspective view of an embodiment of a lock
release actuator.
[0039] FIG. 13B is a perspective view of an embodiment of a lock
release actuator in the activated position.
[0040] FIG. 14A is a perspective view of an embodiment of a
spring.
[0041] FIG. 14B is an end on view of an embodiment of a first
linear actuator.
[0042] FIG. 15 is an end on view of an embodiment of a first linear
actuator with molded spring component.
[0043] FIG. 16 is a perspective view of a spring component.
[0044] FIG. 17 is a schematic of a base jig assembly including
winding jig, wire weight and wire guide.
[0045] FIGS. 18A, 18B and 18C are schematics of a manufacturing
mandrel and an embodiment of a lock loop.
[0046] FIG. 19 is a perspective view of a base jig with a self
centering petal jig attached.
[0047] FIG. 20A is a perspective view of a wire frame of a sealing
device in a deployed configuration.
[0048] FIG. 20B is a side view of a wire frame of a sealing device
shown elongated along a mandrel.
[0049] FIG. 21 is a view of a wire frame of a sealing device.
[0050] FIG. 22A is a side view of a wire frame of a sealing device
shown elongated along a mandrel.
[0051] FIG. 22B is an illustration of an embodiment of a base
jig.
[0052] FIG. 23A is an end on view of a sealing device.
[0053] FIG. 23B is a side view of the sealing device of FIG. 23A in
an elongated configuration on a mandrel.
[0054] FIG. 24A is a perspective view of a base jig.
[0055] FIG. 24B is a side view of a lock loop forming tool.
[0056] FIGS. 25A and 25B show elements of a wire frame forming
device and a wire frame of a sealing device.
[0057] FIGS. 26A-C illustrate an anchor component and method of
attaching anchor component to a sealing device.
[0058] FIG. 27 is an end view of a sealing device wire frame with
an anchor component attached.
[0059] FIG. 28 is a side view of a covered sealing device with
anchor component attached.
[0060] FIGS. 29A-C are illustrations of anchor component forming
tools.
[0061] FIG. 30 is a perspective view of an anchor component.
[0062] FIG. 31 is a perspective view of a wire frame with anchor
components attached.
[0063] FIG. 32 is a perspective view of a winding path and jig for
winding a sealing device with elongated waist area.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0064] A first embodiment provides a sealing device having an
expandable frame formed from a plurality of wires extending from a
proximal end to a distal end of the frame with the wires forming a
proximal and distal eyelet with a sealing member at least partially
encapsulating the expandable wire frame.
[0065] FIG. 1 shows one embodiment of sealing device 100. Sealing
device 100 will be discussed in detail in a later section. Sealing
device 100 may housed within third tube 104. Third tube 104
contains sealing device 100, first tube 102, second tube 108,
retrieval cord 110 and locking loop 111. Third tube 104 may be
manufactured of Pebax.RTM. or any other material with suitable
biocompatible and mechanical properties. A material choice with
radiopacity may also be an option. The third tube 104 may be
manufactured with or without a reinforcing braid to provide
appropriate kink resistance and strength for the chosen
application. Third tube 104 may also be designed with or without a
radiopaque marker band. The design and materials of third tube 104
may be chosen for other properties such as torqueability,
steerability and vascular trauma reduction. One skilled in the art
will appreciate that there are a wide variety of potential
materials that may be used to facilitate the present invention. The
third tube 104 may be of any size but is preferably 10 fr. with an
inner diameter of about 0.048 mm and an outer diameter of about
0.33 mm. Third tube 104 may be used with or without a guidewire and
may include a rapid exchange port 103. The tip of first tube 104 is
preferably curved to aid in navigation and delivery of sealing
device 100 from the access site to the defect with or without a
guidewire.
[0066] Also shown in FIG. 1 is first tube 102. As previously
stated, first tube 102 may be housed within third tube 104. The
first tube 102 may be of any outer diameter size but is preferably
sized to fit within the lumen of the third tube 104. First tube 102
may be manufactured of Pebax.RTM. or any other material with
suitable biocompatible and mechanical properties. First tube 102 is
preferably a triple lumen catheter. The lumens may be of any
geometric shape but are preferably round or oval or a combination
of both. First tube 102 may be used to position and aid in the
deployment of sealing device 100. First tube 102 may be utilized in
conjunction with second tube 108 to cause sealing device 100 to
protrude from the distal tip of third tube 104 once sealing device
100 has reached the defect site. The first tube 102 may also have
the function of retaining sealing device 100 onto the delivery
system until final device deployment. First tube 102 has an opening
109 in the distal most end to allow the locking loop 111 to
protrude during device deployment. The opening 109 and protruding
locking loop 111 provide attachment to the device delivery system.
Locking loop 111 is shown in its extended position prior to
retaining its pre-set shape. The first tube 102 may be surface
treated or coated to enhance the material's biocompatibility or
alter or enhance the surface friction.
[0067] First tube 102 may house the second tube 108. The second
tube 108 is essentially tubular with an oval cross section and can
have an outer diameter suitable to fit inside first tube 102. A
preferred outer diameter range would be from about 1.27.times.0.68
mm and would be flared at the distal end. The second tube 108 may
be fabricated from any suitable biocompatible material including
polymers or metals. A preferable material would be PEEK
(polyetheretherketone). Second tube 108 can be used to aid in the
delivery and deployment of sealing device 100 to a defect site.
Second tube 108 is threaded through the eyelets of sealing device
100 to hold sealing device 100 on the delivery system and to
provide stability while deploying the sealing device 100. Sealing
device eyelets will be discussed further.
[0068] Retrieval cord 110 is looped through two of the smaller
lumens of the first tube 102 and through the proximal eyelet of the
sealing device 100 to provide attachment to the delivery system and
a method of retrieval once the sealing device has been deployed.
Retrieval cord 110 extends through the length of first tube 102
with the ends terminating at the handle used for deploying sealing
device 100. Retrieval cord 110 may be manufactured of any
biocompatible material of sufficient strength and size. A
preferable material is ePTFE (expanded
polytetrafluoroethylene).
[0069] As shown in FIG. 2A sealing device 100 is formed of a wire
frame 200. When situated for delivery, wire frame 200 is at an
extended position on second tube 108 and within third tube 104.
Wire frame 200 may be of any size appropriate for an application
but is preferably sized with finished outer diameters of 15, 20,
25, or 30 mm. The wire frame 200 is formed of continuous wires. Any
number of wires may be used to construct the wire frame 200. A
preferable number of wires is five. The wire frame 200 can be
constructed of wires that have elastic properties that allow for
wire frame 200 to be collapsed for catheter based delivery or
thoracoscopic delivery, and self-expand to a "memory" induced
configuration once positioned in a defect. The elastic wire may be
a spring wire, or a shape memory NiTi (nitinol) alloy wire or a
super-elastic NiTi alloy wire. The elastic wire may also be of a
drawn-filled type of NiTi containing a different metal at the core.
Preferably, wire frame 200 would be constructed of a drawn-filled
type of NiTi wire containing a radiopaque metal at the center. Upon
deployment, the wire structure resumes its deployed shape without
permanent deformation.
[0070] Wire frame 200 and other wire frames shown are formed from
elastic wire materials that have outer diameters between 0.12 and
0.4 mm. In a preferable embodiment, wire outer diameter size would
be about 0.3 mm. When formed, wire frame 200 comprises a distal
bumper 208, distal eyelet 204, locking loop 206, an optional center
eyelet 203, and proximal eyelet 202. FIG. 2B shows the position of
elastic wires during the formation of eyelets 202, 203 and 204 of
wire frame 200.
[0071] FIG. 2C shows a disk formed when wire frame 200 is deployed.
The elastic wires that form wire frame 200 form petals 212 during
deployment. The pre-set elastic wire configuration of wire frame
200 allows the frame to twist during deployment. This twist forms
petals 212. Deployed petals 212 form the outer diameter 214 of the
wire frame 200. Deployed petals 212, when covered with sealing
member 106, form proximal and distal disks, to be discussed
further. Petals 212 are optimally formed to have overlapping zones
216 to improve sealing qualities. The radius of petals 212 may be
maximized to minimize sharp bend angles in the elastic wire and to
minimize unsupported sections of petals 212 that improve sealing
qualities of the device, reduce bending fatigue in the wire and aid
in reducing device loading forces. Deployed petals 212 form a disk
on either side of the center eyelet 203. The deployed configuration
will be discussed further.
[0072] Construction of wire frame 200 may be accomplished by a
variety of means including machine winding with automatic wire
tensioning or by hand winding with weights suspended from each wire
during construction. Shown in FIGS. 3A-C are keyed center pin 300
and button 304, which may be used to aid in the construction of
wire frame 200. One commonly skilled in the art would recognize
that there are many materials suitable for use as a manufacturing
aid or tooling. A preferable material for use in forming a center
pin 300 would be cobalt high strength steel. A preferable material
for use in forming a button 304 and winding jig would be corrosion
resistant tool steel. The winding jig will be discussed further.
Shown in detail in FIG. 3A, keyed center pin 300 may have groove
302, which can be used to secure an elastic wire during device
construction. Keyed center pin 300 can be used to guide an elastic
wire through opening 306 in button 304, the features of which are
illustrated in FIGS. 3B-C. Button 304 is preferably formed with an
indention 308 in the bottom to fit securely in a winding jig. An
elastic wire held in groove 302 and inserted through opening 306 in
button 304 can form a bumper 208 and locking loop 206. Keyed center
pin 300 is also used in the formation of eyelets 202, 203 and 204.
During device construction, after the formation of bumper 208,
elastic wires can be wound around keyed center pin 300 to form a
distal eyelet 202. Other eyelets, 203 and 204 can be formed in a
similar manner. Once keyed center pin 300 is inserted in button 304
an elastic wire may be inserted into grooves in a winding jig.
[0073] A winding jig may be used to secure and form the elastic
wires during construction and processing of the sealing device 100.
A typical winding jig may be constructed as commonly known in the
arts. Materials used for construction of such a winding jig have
been discussed previously. A preferable winding jig is shown in
FIGS. 4A and 4B. FIG. 4A illustrates a side view of the winding jig
400. FIG. 4B shows a view of the top of a preferable winding jig
400. Winding jig 400 contains an aperture 402 that may be shaped
and sized to hold keyed center pin 300 and button 304 during device
construction. Grooves 404 in the jig surface are used to secure and
form the elastic wires into petals 212. Grooves 404 may be of any
diameter but are preferably sized to accommodate an outer diameter
of elastic wire. In one embodiment shown in FIG. 5A, the winding
jig assembly may be used to form a center eyelet 203, a petal
assembly and proximal eyelet 204. The shaped wire may be
constrained in the winding jig assembly, heated and processed to
shape set as commonly known in the arts.
[0074] FIG. 5A shows an embodiment of sealing device 100 which is a
composite assembly of wire frame 200 and sealing member 106.
Sealing member 106 may be attached to wire frame 200 by a bonding
agent. Wire frame 200 may be coated with a bonding agent, for
example fluorinated ethylene propylene (FEP) or other suitable
adhesive. The adhesive may be applied through contact coating,
powder coating, dip coating, spray coating, or any other
appropriate means. In a preferred embodiment, the FEP adhesive is
applied by electrostatic powder coating. Sealing member 106 may be
constructed of a variety of materials, such as DACRON.RTM.,
polyester, polyethylene, polypropylene, fluoropolymers,
polyurethane, foamed films, silicone, nylon, silk, thin sheets of
super-elastic materials, woven materials, polyethylene
terephthalate (PET), collagen, pericardium tissue or any other
biocompatible material. In one embodiment, sealing member 106 can
be formed of a thin porous ePTFE (expanded polytetrafluoroethylene)
substrate. Sealing member 106 is designed to enhance the defect
closure characteristics of sealing device 100 by providing defect
blockage and a medium for cellular in growth.
[0075] Also shown in FIG. 5A are proximal, distal and center
eyelets (202, 203 and 204) respectively covered with sealing member
106 and wrapped with a film. The eyelets 202, 203 and 204 may be
wrapped with a film to encourage adhesion of sealing member 106 to
the device. The film used to wrap eyelets 202, 203, and 204 may be
any biocompatible thin material but is a material preferably
comprised of multiple layers of thin porous ePTFE that may be
laminated with one or more layers of non-porous FEP.
[0076] FIG. 5B illustrates an embodiment of sealing device 100 that
includes a sealing member 508 that partially covers wire frame 200.
A partially covered device may have either the distal or proximal
bulb covered in part or in entirely with a sealing member 508.
[0077] Another embodiment of the device is a self centering device
600. Shown in FIG. 6, self centering device 600 comprises a wire
frame 602 similar to that of wire frame 200. Self centering device
600 is a composite assembly of wire frame 602 and sealing member
604. Wire frame 602 may be constructed with the same techniques and
a material as wire frame 200 but has no center eyelet. Wire frame
602 comprises distal bumper 606, covered distal eyelet 608, covered
proximal eyelet 610, and locking loop 612. The pre-set elastic wire
configuration of wire frame 602 allows the frame to twist upon
deployment and create a centering region 614 of the device 600
during deployment. During deployment, region 614 may center itself
in the defect forming a disk comprised of petals on either side of
region 614 and the defect.
[0078] FIG. 7 shows a sealing device 100 fully deployed. During
deployment, the constraint of the third tube 104 is removed from
device 100 and the device returns to its pre-set shape. During
deployment and locking, lock loop 111 is released from the
constraint of first tube 102 and returns to its pre-set shape,
curling from the proximal eyelet 202. In this manner, the device is
locked in a deployed state. FIG. 7 also illustrates the position of
the proximal and distal disks, elements 702 and 704, in relation to
the proximal, center, and distal eyelets 202, 203, and 204
respectively.
[0079] FIG. 19 shows a base jig and other manufacturing aids used
to manufacture an embodiment shown in FIGS. 20A and 20B and
described in Example 4. As shown in FIGS. 20A and 20B sealing
device 40 is formed of wires 43. Wire frame 40 may be of any size
appropriate for an application but is may be sized with outer
peripheral edge diameters of 15, 20, 25, or 30 mm. The wire frame
40 is formed of continuous wires. Any number of wires may be used
to construct the wire frame 40. FIGS. 20A and 20B show a device
formed from 5 continuous wires. FIG. 20A shows a device in a
deployed configuration while 20B shows a device in an extended
configuration. The wire frame 40 may be constructed of wires that
have elastic properties that allow for wire frame 40 to be
collapsed for catheter based delivery or thoracoscopic delivery,
and self-expand to a "memory" induced configuration once positioned
in a defect. The elastic wire may be a spring wire, or a shape
memory NiTi (nitinol) alloy wire or a super-elastic NiTi alloy
wire. The elastic wire may also be of a drawn-filled type of NiTi
containing a different metal at the core. Wire frame 40 may be
constructed of a drawn-filled type of NiTi wire containing a
radiopaque metal at the center. Upon deployment, the wire structure
resumes its deployed shape without permanent deformation.
[0080] Wire frame 40 and other wire frames shown are formed from
elastic wire materials that have outer diameters between 0.12 and
0.4 mm. When formed, wire frame 40 comprises a first eyelet 41, a
second eyelet 42, a plurality of wires 43, a closed teardrop shape
with an internal area 44 and inner peripheral edge 46 and an outer
peripheral edge 45. In an end view of a deployed device, the outer
peripheral edge 45 is shown as the outermost edge of the wire frame
40. The inner peripheral edge 46 of wire frame 40 is illustrated by
the inner most edge of the internal area 44 of the closed teardrop
shape. In the deployed configuration a wire and closed teardrop
shape will nest or interleaf itself between the wire form of the
next wire of the device. In a deployed configuration, the inner
peripheral edge 46 will at least in part center itself within a
cardiac defect or other tissue gap.
[0081] The wire frame 40 may be covered with a sealing member as
previously described.
[0082] FIG. 21 illustrates an embodiment of the wire frame
described in example 5. The embodiment comprises a proximal 610 and
distal eyelet 608 with at least five wires 602, and a self
centering waist portion 614 similar to that describe previously in
relation to FIG. 6. Such an embodiment may be manufactured of
similar materials and methods as described previously.
[0083] An alternate embodiment of a sealing device may be made by
procuring two sealing device frames and seating one inside the
other. Then covering the resulting frame as previously described.
Such a device is described in example 6. An embodiment such as this
may be manufactured with similar materials and methods as described
previously and subsequently described. This technique may be used
with any of the wire frames described herein.
[0084] An embodiment is illustrated in FIG. 22A and described in
example 8. FIG. 22A illustrates a wire frame 51 of a sealing
device. The embodiment of FIG. 22A comprises a proximal 608 and
distal eyelet 610, a plurality of wires 602, wires forming a wire
frame 51, a self centering waist portion 614, an reniform shape
with an open internal area 53 (not shown) with an inner peripheral
edge 54 and an outer peripheral edge 55. The self centering waist
portion 614 of this embodiment forms a reniform with an open
internal area 53 when in the deployed configuration. In an end view
of a deployed device, the outer peripheral edge 55 is shown as the
outermost edge of the wire frame 51. The inner peripheral edge 54
of wire frame 51 is illustrated by the inner most edge of the open
internal area 53 of the reniform shape. In a deployed
configuration, the inner peripheral edge 54 will at least in part
center itself within a cardiac defect or other tissue gap.
[0085] The wire frame 51, as illustrated in FIG. 22A, has a
relatively short extended length prior to deployment. A delivery
configuration length to deployed radius ratio is about 2.5. Such a
device may be formed of similar materials as described previously
and may be covered with a sealing member also described
previously.
[0086] A lock loop 43 (illustrated in FIG. 18) may be manufactured
separately from the wire frame of the sealing device. The lock loop
43 may be formed of any material suitable for forming a sealing
device wire frame. The lock loop 43 may be made of a different
material or have a different wire diameter than that of the sealing
device wire frame. Lock loop component 43 is manufactured with an
eyelet 49 similar to the eyelets of the sealing devices described
herein. Lock loop 43 may be attached to any sealing device wire
frame prior to or post sealing member attachment. Any suitable
method of attaching the separate lock loop component to the sealing
device may be used. A method of manufacture of a lock loop
component is described further in example 9.
[0087] FIGS. 23A and B illustrates an embodiment comprising a
proximal 608 and distal eyelet 610, a plurality of wires 52, wires
forming a wire frame 61, a self centering waist portion 614, an
reniform shape with an open internal area 53 (not shown) with an
inner peripheral edge 54 and an outer peripheral edge 55 and a
sealing member 604. The self centering waist portion 614 of this
embodiment forms a reniform with an open internal area 53 when in
the deployed configuration. In an end view of a deployed device,
the outer peripheral edge 55 is shown as the outermost edge of the
wire frame 51. The inner peripheral edge 54 of wire frame 51 is
illustrated by the inner most edge of the open internal area 53 of
the reniform shape. In a deployed configuration, the inner
peripheral edge 54 will at least in part center itself within a
cardiac defect or other tissue gap. This embodiment may be
constructed with two frames previously described. This embodiment
may be constructed of two frames wound in opposite directions or
with two frames wound in the same direction. This and the other
described wire frames may be constructed with the eyelets
configured either as shown or with the eyelets turning toward the
center area of the frame along the inner diameter of the device.
Materials suitable for use as a sealing member 604 have been
discussed previously. Sealing member may be attached to the frame
in this and other described embodiments as discussed previously.
Sealing member in this and other embodiments may be attached to the
interior or inner surface of the wire frame and alternately to the
exterior of the frame. The sealing member may be attached at only
portions of the wire frame leaving certain portions of the wire
frame more degrees of freedom of movement. Sealing member might
also be attached to cover one side, portions or the entire wire
frame.
[0088] Another embodiment is shown in FIG. 25B. This embodiment may
be constructed with similar materials as those described
previously. The embodiment comprises a wire frame 78, first and
second eyelets (73 and 75 respectively), a sealing disc 77, a plug
region 79 and optionally a sealing member 604 (not shown). The
embodiment may be constructed of any of the previously described
wire frames. The sealing disc portion 77 of the embodiment is
adapted to cover a wide range of opening sizes while the plug
region 79 is adapted to conform to the anatomy into which it is
inserted over its entire length. Sealing disc portion 77 has
minimal deformation under radial pressure changes or radial
pressure exerted upon the plug region 79. Sealing disc 77 and plug
region 79 have substantial directional independence due to the
flexibility of waist portion 614: that is, the longitudinal axis of
the first eyelet 73 may be at significant offset with respect to
the longitudinal axis of the second eyelet 75.
[0089] Anchor components or fixation devices may be attached to any
of the embodiments. Examples of anchor complements (80 and 96) are
shown in FIGS. 26A and 30. FIG. 26A illustrates an anchor component
80 with fixation elements configured to pierce, puncture or
protrude into tissue adjacent to the device during or after
deployment. Anchor component 96 in FIG. 30 illustrates fixation
elements configured with blunt ends designed to grasp or engage the
adjacent tissue without substantially protruding into the tissue.
Other anchor components may be envisioned including anchor
components configured to possess both piercing and grasping
capabilities. Such an anchor component may be similar to that shown
in FIG. 30 but instead of having looped wire arm, have a single
wire arm with a looped end the end of which may be crimped or
positioned to either be in the same plane as the single wire arm or
to protrude from the plane thereby being available to pierce or
puncture tissue. Anchor components may be attached at any eyelet of
the device. Anchor components may be configured to bend in any
direction. Single or multiple anchor components may be affixed to
any device or wire frame in any combination. Said anchors can be
designed to release the tissue for repositioning and/or retrieval.
Further, when the sealing device is in a delivery configuration,
the barbs may be collapsed to avoid catching on the catheter
components during retrieval of the device.
[0090] FIG. 8 shows a perspective view of sealing device 100
attached to a delivery system including first tube 102, third tube
104, and a handle for deploying a sealing device 100. FIG. 8
further illustrates a first linear actuator 802, a flushing port
804, the second linear actuator 806, lock release actuator 808, a
housing 810 and a slot with a length in the housing 812. First
linear actuator 802 may have a variety of configurations which will
be discussed further.
[0091] FIGS. 9A-D are flow charts which describe the movements of
the various components of the delivery system and attached sealing
device 100 during use. Loading sealing device 100 into the delivery
system prior to use is described in FIG. 9A. Components of the
delivery system handle are shown in FIGS. 8, 10 and 11. A clinician
may flush the delivery system by attaching a syringe or other
suitable implement onto flushing port 804 and filling the system
with saline or any other appropriate flushing material. The first
linear actuator 802 may then be moved in slot 812 in housing 810
against a spring 1100. Spring 1100 may be configured as shown or
may be formed as a leaf spring, stepped spring or any form commonly
known in the arts. This action rotates the mandrel control lever
1000, shown in FIG. 11, about a slider rod 1102 to the side of
housing 810. This same motion moves the first linear actuator 802
free of distal notch 1104 in the sizing insert 1103 and prevents
the second tube 108 from translating either proximally or distally.
Sizing insert 1103 may be of any material with suitable mechanical
properties.
[0092] Typical handles, handle components, tools or catheters used
to deliver medical devices can comprise commonly known materials
such as Amorphous Commodity Thermoplastics that include Polymethyl
Methacrylate (PMMA or Acrylic), Polystyrene (PS), Acrylonitrile
Butadiene Styrene (ABS), Polyvinyl Chloride (PVC), Modified
Polyethylene Terephthalate Glycol (PETG), Cellulose Acetate
Butyrate (CAB); Semi-Crystalline Commodity Plastics that include
Polyethylene (PE), High Density Polyethylene (HDPE), Low Density
Polyethylene (LDPE or LLDPE), Polypropylene (PP), Polymethylpentene
(PMP); Amorphous Engineering Thermoplastics that include
Polycarbonate (PC), Polyphenylene Oxide (PPO), Modified
Polyphenylene Oxide (Mod PPO), Polyphenelyne Ether (PPE), Modified
Polyphenelyne Ether (Mod PPE), Thermoplastic Polyurethane (TPU);
Semi-Crystalline Engineering Thermoplastics that include Polyamide
(PA or Nylon), Polyoxymethylene (POM or Acetal), Polyethylene
Terephthalate (PET, Thermoplastic Polyester), Polybutylene
Terephthalate (PBT, Thermoplastic Polyester), Ultra High Molecular
Weight Polyethylene (UHMW-PE); High Performance Thermoplastics that
include Polyimide (PI, Imidized Plastic), Polyamide Imide (PAI,
Imidized Plastic), Polybenzimidazole (PBI, Imidized Plastic);
Amorphous High Performance Thermoplastics that include Polysulfone
(PSU), Polyetherimide (PEI), Polyether Sulfone (PES), Polyaryl
Sulfone (PAS); Semi-Crystalline High Performance Thermoplastics
that include Polyphenylene Sulfide (PPS), Polyetheretherketone
(PEEK); and Semi-Crystalline High Performance Thermoplastics,
Fluoropolymers that include Fluorinated Ethylene Propylene (FEP),
Ethylene Chlorotrifluroethylene (ECTFE), Ethylene, Ethylene
Tetrafluoroethylene (ETFE), Polychlortrifluoroethylene (PCTFE),
Polytetrafluoroethylene (PTFE), Polyvinylidene Fluoride (PVDF),
Perfluoroalkoxy (PFA). Other commonly known medical grade materials
include elastomeric organosilicon polymers, polyether block amide
or thermoplastic copolyether (PEBAX) and metals such as stainless
steel and nickel/titanium alloys.
[0093] A distal notch 1104 and proximal notch 1106 in sizing insert
1103 may be used to aid in the positioning of the first linear
actuator 802 in housing slot 812. The distance between the two
notches, 1104 and 1106 respectively, may be the length of sealing
device 100 when it is elongated over second tube 108 prior to
loading onto the delivery system. Sizing insert 1103 may be sized
to accommodate a variety of device lengths and is preferably from
about 22.28 cm long with a distance between the proximal end of
distal notch 1104 and proximal end of proximal notch 1106 from
about 6.25-13.32 cm. Notches 1104 and 1106 may be of any shape but
are preferably rectangular.
[0094] The first linear actuator 802 is then moved to a mid point
in slot 812 toward the proximal end of the housing 810. This action
causes the first tube 102 to move proximally and the sealing device
100 proximal end to move proximally, thus elongating sealing device
100. First linear actuator 802 may be any shape (lever, ball) but
is preferably shaped to accommodate a clinician's thumb. First
linear actuator 802 may be constructed of any material with
suitable mechanical properties but is preferably a material similar
to that of sizing insert 1103. A feature of the first linear
actuator 802 are recessed teeth formed in the top portion of the
first linear actuator 802 for securing retrieval cord 110. This
feature is preferred but optional. The teeth could be made into any
tortuous path or have any shape desired to create resistance for
retrieval cord 110 during loading, deployment, or retrieval of
sealing device 100. Corresponding protruding teeth (not shown) may
be formed in the bottom surface of retrieval cord lock 803. These
teeth may fit together and hold the retrieval cord firmly. Other
methods commonly known in the art for securing a small diameter
cord may also be used and will be discussed in detail in a
following section.
[0095] The first linear actuator 802 is then moved further
proximally until the device is loaded in third tube 104. During
this action, spring 1100 pushes the first linear actuator 802 and
the mandrel control lever 1000 to the left of slot 812 and into the
proximal notch 1106 in sizing insert 1103. The second tube 108 is
free to move proximally with sealing device 100 and first tube 102.
As the first linear actuator 802 is moved proximally, the second
tube 108, sealing device 100 and first tube 102 slide or translate
into the third tube 104. After the first linear actuator 802 is in
its proximal most position, the system may again be flushed with
saline in the manner described above.
[0096] Alternate embodiments of first linear actuator 802 are shown
in FIGS. 12A-D. FIG. 12A shows a perspective view of the alternate
linear actuator 1108 in the locked retrieval cord position. Linear
actuator 1108 is similar in construction to linear actuator 802 but
features a retrieval cord locking ring 1110 and retrieval cord
groove 1112. FIG. 12B depicts alternate embodiment 1114, which is
configured with a thumb wheel 1116 that extends beyond the sides of
the linear actuator to facilitate easy manipulation. Thumb wheel
1116 is screwed onto a threaded post 1118 around which the
retrieval cord is wound. Embodiment 1114 also contains a retrieval
cord groove 1120 through which the retrieval cord is guided prior
to securing it around threaded post 1118. FIG. 12C illustrates yet
another embodiment 1122 that utilizes a side fitted threaded thumb
wheel 1124 around which the retrieval cord is wound and secured to
the actuator 1122 by the act of inserting the threaded post 1124
into a threaded aperture (not shown) in the side of the actuator
1122. Prior to threading the retrieval cord around the threaded
post 1124, the retrieval cord is inserted through the retrieval
cord groove 1126. Yet another embodiment 1128 is shown in FIG. 12D.
Embodiment 1128 shows a linear actuator with molded thumb wheel
1130. The thumb wheel 1130 extends slightly beyond the edges of the
linear actuator facilitating manipulation of the linear actuator.
The retrieval cord is inserted through cord groove 1132 and wound
around a threaded post (not shown). The molded thumb wheel 1130 is
then secured on the threaded post securing the retrieval cord.
[0097] Deploying sealing device 100 into a defect is described in
FIG. 9B. The first linear actuator 802 is moved distally until a
stop is reached. This movement causes the first tube 102 and second
tube 108 to move distally within the third tube 104. The linear
actuator 802 must then be moved to the right in slot 812, against
spring 1100. When the linear actuator 802 is moved to the right,
mandrel control lever 1000 rotates on slider rod 1102. This action
causes the linear actuator 802 to be free of the proximal notch
1106 in sizing insert 1103. After this action, the linear actuator
802 is further translated distally. This causes the first tube 102
and proximal eyelet 202 of sealing device 100 to move distally.
Also affected by this action is the distal end of sealing device
100 which is prevented from moving. The first tube 102 guides the
device out of the third tube 104 to deploy the device in a defect.
Moving linear actuator 802 distally to the end of slot 812 results
in the entire sealing device being deployed. One skilled in the art
would recognize that the steps described above could be halted and
reversed at certain points to allow optimal positioning of sealing
device 100.
[0098] Locking the device is described in the flowchart illustrated
in FIG. 9C. The retrieval cord lock 803 would be unsnapped from the
first linear actuator 802. A clinician would grasp the second
linear actuator 806 by gripping attached lock release actuator 808
and press it toward the middle of housing 810. The second linear
actuator 806 may be of any size or shape but is preferably sized to
fit within a slot 1002 in the longitudinal surface of housing 810.
Linear actuator 806 is fitted with lock release actuator 808 by
means of a snap fitting. Any means of attachment would suffice to
fasten lock release actuator 808 to linear actuator 806 such as
glue or construction as a molded part. Materials appropriate for
both the second linear actuator 806 and lock release actuator 808
may be any material of suitable mechanical properties but are
preferably similar to that of the previously mentioned handle
components. Lock release actuator 808 is designed to enable a user
to grip the device securely. Gripping may be aided by protrusions
on the lateral sides of the lock release actuator 808. These
protrusions may be made of a similar material as that of the lock
release actuator 808 or may be made of a material with a high
coefficient of friction or of a material more compliant than that
of lock release actuator 808. These protrusions may also be made
with grating, a roughening, a raised design, or striations in the
surface in conjunction with the material listed above to further
aid in the gripping of the device. These features on the surface of
lock release actuator 808 may also be used to aid in gripping
without the use of gripping protrusions and may be applied directly
to the lateral surface of the second linear actuator 806. Slot 1002
may be configured to have a stop to hold the second linear actuator
806 in a distal most position until lock release of the sealing
device. A preferred stop is shown in FIGS. 10 and 11 in the form of
a corrugated area but may also be any manner of mechanical stop.
Slot 1002 may be of any length but preferably has a length
sufficient to translate motion proximally about the width of the
second linear actuator 806 plus about 3.18 cm. Slot 1002 may be any
shape that would accommodate the second linear actuator 806.
[0099] An alternate embodiment of second linear actuator 806 is
shown in FIGS. 13A and 13B. Instead of gripping lock release
actuator 808 and activating second linear actuator 806 a rotatable
lock release actuator 1300 is gripped and rotated to affect lock
release. The rotatable lock release actuator 1300 may contain a
window 1302 which would prevent forward movement of the first
linear actuator 802. When rotated, lock release actuator 1300
allows the same actions as lock release actuator 806 shown in FIG.
10.
[0100] Once the second linear actuator 808 is gripped, a clinician
may move the second linear actuator 806 proximally. This action
results in proximal movement of third tube 104, mandrel control
lever 1000, sizing insert 1103 and second tube 108. Second tube 108
moves proximally from between eyelets of the device. An alternate
method of achieving this action would be to provide a twist
mechanism to the distal end of the handle instead of a second
linear actuator 806. This twist mechanism would be provided with a
slot that allows for the same movement of the third tube 104,
mandrel control lever 1000, sizing insert 1103 and second tube 108
as the second linear actuator 806.
[0101] Once lock release has been achieved, the retrieval cord lock
803 is then twisted to remove it from the first linear actuator 802
and pulled until the retrieval cord 110 is free of the delivery
system. Retrieval cord 110 is attached to the retrieval cord lock
803 at one end. Retrieval cord 110 may be constructed of any
material with suitable mechanical properties such as Kevlar.RTM.,
flexible metal wire, polymers and the like. A preferably material
for retrieval cord 110 is an ePTFE fiber. Retrieval cord lock 803
may be configured in a variety of shapes and sizes. Possible
retrieval cord locks may be designed to provide a slot in the
linear actuator 802 through which the retrieval passes. In one
configuration, the retrieval cord is secured by passing the cord
through a slot or hole in the axis of the thumb wheel disposed in
the linear actuator 802 and tightened by twisting the thumb wheel.
An alternate configuration would provide a slide lock that binds
the retrieval cord between the lock and the linear actuator 802
using friction. A preferred design would be to secure the retrieval
cord between teeth formed in the retrieval cord lock as shown in
FIG. 11.
[0102] Materials suitable for constructing retrieval cord lock 803
are similar to that used to construct housing 810 and other handle
components. As mentioned previously, retrieval cord lock 803
preferably has teeth or protrusions that correspond to indentations
in linear actuator 802 for the purpose of gripping retrieval cord
110. Retrieval cord lock 803 may be configured in a variety of
shapes to enable retrieval cord 110 to be secured. A preferred
configuration would include apertures through the retrieval cord
lock 803 to allow retrieval cord 110 to be threaded therethrough
and knotted. After twisting the retrieval cord lock 803, it is
pulled until the retrieval cord 110 is removed from the delivery
system.
[0103] Prior to the step four described in FIG. 9C, the sealing
device 100 may be retrieved as described in the flowchart
illustrated in FIG. 9D. The retrieval cord lock 803 may be snapped
into the first linear actuator 802. This serves to lock the
retrieval cord 110 in place. The clinician then moves the first
linear actuator 802 to the right edge of slot 812. The first linear
actuator 802 moves in slot 812 to the right pressing on spring 1100
while the mandrel control lever 1000 rotates on the slider rod 1102
to the right of the handle. Slider rod 1102 is preferably of a
round cross-section but one skilled in the art would recognize that
a variety of cross-sectional shapes (e.g. square or triangular)
would be acceptable. Slider rod 1102 could also be configured in
the shape of a crown spring 1400 as shown in FIGS. 14A and B. The
spring could be inserted in a slot 1402 through the linear actuator
to allow fore and aft translation of the linear actuator. An
alternate embodiment of spring 1100 may be a spring molded as an
integral part 1500 of first linear actuator 802 as illustrated by
FIG. 15. Another embodiment of spring 1100 is shown in FIG. 16. In
this configuration, a spring 1600 is attached to housing 810 and
pushes on the first linear actuator 802 in key positions. As stated
above, one skilled in the art would recognize the appropriate
materials for use as a spring or molded part. The first linear
actuator 802 is free of distal notch 1104 and the second tube 108
is prevented from moving. The first linear actuator is moved
proximally by the clinician causing first tube 102 to move
proximally. This motion translates the proximal end of sealing
device 100 proximally elongating the device 100 and allowing it to
be pulled into the third tube 104.
EXAMPLES
[0104] Without intending to limit the scope of the invention, the
following examples illustrate how various embodiments of the
invention may be made and/or used.
Example 1
[0105] A sealing device similar to FIG. 1 was manufactured using
the following components and assembly process.
[0106] An expanded polytetrafluoroethylene material was obtained
with the following properties:
[0107] Methanol bubble point of 1 psi
[0108] Mass/area of 2.2 grams/square meter
[0109] Longitudinal maximum load of 1.6 kg/inch
[0110] Thickness of 0.0003 inch
[0111] Longitudinal matrix tensile strength of 92000 psi
[0112] The following test methods and equipment were used to
determine the above-mentioned properties: Methanol bubble point was
measured using a custom built machine with a 1 inch diameter foot,
a ramp rate of 0.2 psi/second and a liquid media of methanol.
Length and width of the material were measured using a metal ruler.
Mass/area was measured using a balance (Model GF-400 Top Loader
Balance, ANG, San Jose Calif.) with a 36.times.5 inch sample.
Longitudinal maximum load was measured using a materials test
machine (Model 5564, Instron, Grove City, Pa.) equipped with a 10
kg load cell. The gauge length was 1 inch and the cross head speed
was 25 mm/minute. Sample width was 1 inch. Longitudinal tensile
test measurements were taken in the length direction of the
material. Thickness was measured using a thickness gauge (Mitutoyo
Digital Indicator 547-400) with a foot diameter of 1/4 inch. The
longitudinal matrix tensile strengths (MTS) were calculated using
the following equation: Density was calculated using the formula,
density=mass/volume.
Matrix Tensile Strength = ( .sigma. sample ) * ( .rho. PTFE ) (
.rho. sample ) ##EQU00001##
[0113] An expanded polytetrafluoroethylene with a thin layer of FEP
(fluorinated ethylene propylene) material was obtained with the
following properties:
[0114] Mass/area of 36.1 grams/square meter
[0115] Maximum Load, Longitudinal of 12.6 kg/inch
[0116] Maximum Load, Transverse of 0.3 kg/inch
[0117] Thickness of 0.0012 inch
[0118] The following test methods and equipment were used to
determine the above-mentioned properties: Material was weighed
using a precision analytical balance (Model GF-400 Top Loader
Balance, ANG, San Jose Calif.) with a sample area of 36.times.1
inch sample. Length and width of the material were measured using a
metal ruler. Material thickness was measured using a digital
thickness gauge (Mitutoyo Digital Indicator 547-400) with a foot
diameter of 1/4 inch. Maximum transverse load was measured using a
materials test machine (Model 5564, Instron, Grove City, Pa.)
equipped with a 10 kg load cell. The sample width was 1 inch, the
gauge length was 1 inch and the cross head speed was 25 mm/minute.
Maximum longitudinal load was measured using a materials test
machine (Model 5564, Instron, Grove City, Pa.) equipped with a 200
kg load cell. The sample width was 1 inch, the gauge length was 1
inch and the cross head speed was 25 mm/minute. Longitudinal
tensile test measurements were taken in the length direction of the
material and transverse tensile test measurements were taken in the
direction orthogonal to the length direction.
[0119] A distal eyelet was formed by first obtaining a length of
10% platinum drawn filled nitinol wire (Fort Wayne Metals, Fort
Wayne, Ind.) with a diameter of about 0.23 mm. This wire was
labeled "first wire". A free end of the first wire was doubled on
itself to create an open-ended loop and the open-ended loop was
inserted into the button. The button was then inserted onto the
keyed center pin. The button was shaped to have an opening through
the center to accommodate the keyed center pin and to have features
that allow it to rest securely in the winding jig. The keyed center
pin (major axis of about 0.51 mm and minor axis of about 0.25 mm
and length of about 10.16 mm) was then inserted in the center of a
winding jig. The keyed center pin was fabricated from high strength
steel (Super Cobalt HSS Tool Bit, MSC#56424278, Seco Fagersta). The
steel was tempered per manufacture's instructions at 1475.degree.
F. for one hour. The winding jig and button were fabricated in
house from corrosion resistant tool steel.
[0120] A second length of the same type of drawn filled nitinol
wire was obtained and labeled "fifth wire". The first, fifth and an
additional three wires were tensioned by attaching weights to the
wire ends. The first wire and the fifth wire were then wound around
the free end of the first wire one full revolution. The three
additional wires were introduced to the winding jig and all five
wires were wound around the free end of the first wire to a height
of about 1.98 mm.
[0121] A distal disk was then formed by separating the five wires
and securing them in radial grooves around the circumferential edge
of the winding jig. A radius was formed with the dimensions of 15
mm. Each wire formed one petal of the distal disk. The radius on
the curvature of the petals was maximized in order to minimize
sharp bend angles in the wire.
[0122] A center eyelet was formed by grouping the wires together
and winding them around the free end of the first wire and the
keyed center pin to a height of about 1.98 mm. The wires were then
separated and secured in radial grooves around the circumferential
edge of the winding jib creating a proximal disk with a radius of
15 mm.
[0123] A proximal eyelet was formed by again grouping the five
wires and winding them around the free end of the first wire and
the keyed center pin to a height of about 1.98 mm. The five wires
were then separated and secured by placing a stainless steel plate
on top of the wires and locking down the plate with screws. The
free end of the first wire was then wound one revolution around a
stainless steel pin with a diameter of about 3.18 mm and secured
similarly to the other five wires.
[0124] The jig with sealing device was then removed from the
stabilizing fixture and placed in an oven (BlueM SPX Electric
Forced Air Convection Oven) and the wires were thermally shape set
as commonly known in the arts. The device and jig were then water
quenched. The secured wires were released from the securing plate
and the device was chilled and removed from the jig and keyed
center pin. The device was then placed on a piece of flattened PEEK
(polyetherether ketone) and trimmed by hand to the outer diameter
of the distal eyelet. The lock loop was trimmed by hand to a point
just beyond one complete revolution and pulled through the proximal
and center eyelets.
[0125] The device was pushed from the PEEK mandrel onto a keyed
stainless steel process mandrel with an oval cross section. The
mandrel was produced from flattened stainless steel wire (Ft. Wayne
Metals, Fort Wayne, Ind.) with an oval cross-section to have a
45.degree. clockwise twist between the proximal eyelet and the
center eyelet and a second 45.degree. clockwise twist between the
center eyelet and the distal eyelet.
[0126] The process mandrel and device were then placed in a
stabilizing fixture which was placed in a FEP powder coating
machine (C-30, Electrostatic Technology, Inc., Bradford, Conn.) and
processed until coated completely. Excess FEP powder was removed
from the device. The FEP was vacuumed from the lock loop, process
mandrel and bumper. The process mandrel and device were removed
from the stabilizing fixture, placed into an oven and baked to set
the FEP coating as commonly known in the arts.
[0127] A hollow core film mandrel (35.99 mm O.D. 76.2 cm long
stainless steel) was obtained. Expanded polytetrafluoroethylene
material with a slit width of 22.22 mm was obtained and loaded onto
a spiral wrapping machine. The machine was manufactured in house to
wrap PTFE (polytetrafluoroethylene) material at any desired angle,
tension and rate. The mandrel was loaded onto the wrapping machine
and the material was wrapped three times around the circumference
of the hollow core mandrel. The material was then wrapped around
the mandrel at an angle of about 8.degree. for the length of the
mandrel. The direction of wrapping was reversed and the material
over wrapped at the same angle. The third and fourth layers were
wrapped in the same manner with the seams offset. The mandrel was
removed from the wrapping machine, inserted in an oven and baked at
370.degree. C. for 45 minutes. The wrapped mandrel was removed from
the oven and allowed to cool to room temperature. The resulting
PTFE tube was removed from the mandrel.
[0128] The PTFE tube was then cut to about 140 mm and hand
stretched to a desired length 155 mm. The PTFE tube was then pulled
over the frame. The PTFE tube was then crimped onto the center
eyelet and then crimped onto the distal and proximal eyelets.
[0129] An expanded polytetrafluoroethylene with a thin layer of FEP
(fluorinated ethylene propylene) material was then wrapped four
times around the eyelets starting with the center eyelet. The
wrapped eyelets were tacked into place a soldering iron. The PTFE
tube was then heat set for 3 minutes at 320.degree. C. and trimmed
to the outer most points of the proximal and distal eyelets. The
device was removed from the mandrel.
Example 2
[0130] A sealing device similar to FIG. 6 was manufactured using
the following components and assembly process.
[0131] Expanded polytetrafluoroethylene and expanded
polytetrafluoroethylene with a thin layer of FEP (fluorinated
ethylene propylene) materials similar to that described in Example
1 were obtained.
[0132] A distal eyelet was formed by first obtaining a length of
10% platinum drawn filled nitinol wire (Fort Wayne Metals, Fort
Wayne, Ind.) with a diameter of about 0.23 mm. This wire was
labeled "first wire". A free end of the first wire was doubled on
itself to create an open-ended loop and the open-ended loop was
inserted into the button. The button was then inserted onto the
keyed center pin. The button was shaped to have an opening through
the center to accommodate the keyed center pin and to have features
that allow it to rest securely in the winding jig. The keyed center
pin (major axis of about 5.79 mm and minor axis of about 0.25 mm
and length of about 10.16 mm) was inserted in the center of a
winding jig. The keyed center pin was fabricated from high strength
steel (Super Cobalt HSS Tool Bit, MSC#56424278, Seco Fagersta). The
winding jig and button were fabricated in house from corrosion
resistant tool steel.
[0133] A second length of the same type of drawn filled nitinol
wire was obtained and labeled "fifth wire". The first, fifth and an
additional three wires were tensioned by attaching weights to the
wire ends. The first wire and the fifth wire were then wound around
the free end of the first wire one full revolution. The three
additional wires were introduced to the winding jig and all five
wires were wound around the free end of the first wire to a height
of about 1.98 mm.
[0134] A device was then formed by separating the five wires and
securing them in radial grooves around the circumferential edge of
the winding jig. A radius was formed with the dimensions of 15 mm.
Each wire made an entire revolution around the winding jig.
[0135] A proximal eyelet was formed by grouping the five wires and
winding them around the free end of the first wire and the keyed
center pin to a height of about 1.981 mm. The five wires were then
separated and secured by placing a stainless steel plate on top of
the wires and locking down the plate with screws. The free end of
the first wire was then wound one revolution around a stainless
steel pin with a diameter of about 3.18 mm and secured similarly to
the other five wires.
[0136] The jig with sealing device was removed from the stabilizing
fixture and placed in an oven (Blue M SPX Electric Forced Air
Convection Oven) where the wires were partially thermally shape set
as commonly known in the arts. The device and jig were then water
quenched. The secured wires were released from the securing plate
and then the device was chilled and removed from the jig and keyed
center pin. The lock loop was trimmed by hand to a point just
beyond one complete revolution and pulled through the proximal and
center eyelets.
[0137] The device was pushed from the PEEK mandrel onto a keyed
stainless steel transfer mandrel with an oval cross section. The
mandrel was produced from flattened stainless steel wire (Ft. Wayne
Metals, Fort Wayne, Ind.) with an oval cross-section. The device
was then partially removed from one end of the transfer mandrel.
The removed device end was twisted approximately 180.degree.
clockwise and repositioned on the transfer mandrel. The device and
transfer mandrel were placed in an oven (Blue M SPX Electric Forced
Air Convection Oven) where the wires were thermally shape set as
commonly known in the arts.
[0138] The transfer mandrel and device were then placed in a
stabilizing fixture which was placed in a FEP powder coating
machine (C-30, Electrostatic Technology, Inc., Bradford, Conn.) and
processed until coated completely. Excess FEP powder was removed.
FEP powder was vacuumed from the lock loop, process mandrel and
bumper. The transfer mandrel and device were then removed from the
stabilizing fixture, placed into an oven and baked to set the FEP
coating as commonly known in the arts.
[0139] A hollow core film mandrel (35.99 mm O.D. 76.2 cm long
stainless steel) was obtained. An ePTFE material with a slit width
of 22.24 mm was obtained and loaded onto a spiral wrapping machine.
The machine was manufactured in house to wrap ePTFE film at any
desired angle, tension and rate. The mandrel was loaded onto the
wrapping machine and the film was wrapped three times around the
circumference of the hollow core mandrel. The ePTFE material was
then wrapped around the mandrel at an angle of about 8.degree. for
the length of the mandrel. The direction of wrapping was reversed
and the material over wrapped at the same angle. The third and
fourth layers were wrapped in the same manner with the seams
offset. The mandrel was removed from the wrapping machine, inserted
in an oven and baked at 370.degree. C. for 45 minutes. The wrapped
mandrel was removed from the oven and allowed to cool to room
temperature. The resulting ePTFE tube was removed from the
mandrel.
[0140] The ePTFE tube was then cut to about 140 mm and hand
stretched to a desired length 155 mm. The ePTFE tube was then
pulled over the frame. The ePTFE tube was then crimped onto the
distal and proximal eyelets. An ePTFE with a thin layer of FEP
(fluorinated ethylene propylene) material was then wrapped four
times around the eyelets. The wrapped eyelets were tacked into
place a soldering iron. The ePTFE tube was then heat set for 3
minutes at 320.degree. C. and trimmed to the outer most points of
the proximal and distal eyelets. The device was then removed from
the mandrel.
Example 3
[0141] An handle assembly similar to FIG. 8 was manufactured using
the following components and assembly process.
[0142] Components for the handle assembly were fabricated using an
injection molding process. The parts were fabricated by Contour
Plastics (Baldwin, Wis.) using Lustran.RTM. 348. This material was
suitable for use in medical devices and has an advertised tensile
strength of 48.2 MPa and a tensile modulus of 2.62 GPa. Nine parts
were fabricated using this injection process and Lustran.RTM. 348.
The parts included the second linear actuator, flushing gasket
retainer, a first linear actuator, retrieval cord lock, mandrel
control lever, left body housing, sizing insert, right body
housing, and a lock release actuator.
[0143] Other materials required for the assembly of the handle were
purchased items. A catheter tube formed with a layup process
commonly known in the arts was ordered (Teleflex Medical, Jaffrey,
N.H.) with an I.D. of 0.048 mm and an O.D. of 0.33 mm and a
platinum iridium marker band placed near the end of the distal tip.
The main body of the catheter tube was Pebax.RTM. 7233 tube with
PTFE liner and stainless steel braid (65 PPI) and the distal most
20.32 mm of the catheter tube was comprised of 6333 Pebax.RTM.
(0.027 mm I.D. and an 0.033 mm O.D.) and a curve in the distal end
(39.98 mm radius). A guidewire port formed by a laser was placed in
the catheter tube proximal of the marker band. A flushing gasket or
u-cup type gasket made of silicone (22.99 mm depth, I.D. tapered
from 2.89 mm to 1.85 mm I.D. tapered from 6.71 mm to 7.75 mm) was
procured from Apple Rubber of Lancaster, N.Y. A flushing port
(Merit Medical, South Jordan, Utah) having an about six inch
flexible pvc (polyvinyl chloride) tube with a 3.18 mm O.D. female
luer connector was obtained. A quick set cyanoacrylate adhesive was
supplied from in-house stock. Stainless steel hypotubes were
ordered from Small Parts, Inc. (1.45 mm O.D., 1.30 mm I.D., length
of 30.48 cm.). Slider rods (PTFE coated stainless steel hypotubes,
3.18 mm O.D., 1.65 mm I.D., length of 33.02 cm) were procured from
Applied Plastics. Control springs (PTFE-coated stainless steel leaf
springs, thickness 0.10 mm, minor flange length 5.33 mm, major
flange length 10.11 mm, overall length 15.88 mm) were ordered from
Incodema of Ithaca, N.Y.
[0144] The remainder of the components were supplied from in house
stock or manufactured in house. All triple lumen tubes were
manufactured of Pebax.RTM. 7233 with 20% barium sulfate. Both
triple lumen tubes had an O.D. (outer diameter) of 0.25 mm. One
triple lumen tube had round lumens with two I.D.s (inner diameters)
of 0.035 mm and one I.D. of 0.15 mm. One triple lumen tube had one
lumen with an oval cross-section with two I.D.s of 0.036 mm and one
I.D of 0.127.times.0.07 mm. Stainless steel PTFE coated
(polytetrafluoroethylene) process mandrels were manufactured in
house. One process mandrel had a cross-sectional shape that
transitioned from round (O.D. of 0.16 mm) to oval (O.D. of
0.14.times.0.07 mm). PTFE covered stainless steel wire was procured
from in house stock (O.D. 0.03 mm). Standard luer fittings were
obtained from in house stock. A PEEK (polyetheretherketone) second
tube extrusion was obtained from in house stock with an oval
cross-section of 1.27.times.0.69 mm O.D.
[0145] A first tube was made in the following manner. One triple
lumen extruded tube with round lumens was obtained. Another triple
lumen extruded tube was obtained with one lumen having an oval
cross-section. A stainless steel processing mandrel was also
obtained having a cross-sectional shape, which transitions from
round (O.D. of 1.52 mm), to oval (O.D. of 1.39.times.0.81 mm). Both
extruded tubes were loaded onto the mandrel with the mandrel being
inserted through the larger lumen on both tubes. Two small PTFE
covered stainless steel wires were inserted through the smaller
lumens of both extruded tubes. The mandrel and tubes were inserted
into a RF (radio frequency) die (2.51 mm I.D., 4.45 mm length,
fabricated from D2 tool steel). The junction of the two catheters
was positioned in the center of the RF die. The RF die and mandrel
was placed in the middle of an RF coil on an RF welding machine
(Hot Shot I, Ameritherm Inc., Scottsville, N.Y.) and welded as
commonly known in the art. When the components had reflowed,
pressure was applied to each end of the extruded tubes to meld the
junction of the tubes. The die was then sprayed with compressed air
to cool the die and to set the Pebax.RTM.. The extruded tube and
die were removed from the RF machine and the extruded tube was
removed from the die. The process mandrel and wires were removed
from the lumens of the extruded tube.
[0146] A lubricious coating may be applied to the second tube. A
silicone mold release spray (Nix Stix X-9032A, Dwight Products,
Inc., Lyndhurst N.J.) may be sprayed onto about the distal 30 cm of
the second tube and allowed to dry at ambient temperature under a
fume hood.
[0147] A third tube sub-assembly was made in the following manner.
A catheter tube was bisected with a straight razor at approximately
6.35 cm from the proximal end of the catheter tube. A male and
female in-line luer connector (Qosina, Edgewood, N.Y.) was obtained
and drilled to an I.D. of 3.45 mm. U.V. (ultra-violet) cured
adhesive (Loctite 3041) was applied to the bisected ends of the
catheter tube and the drilled luer fittings were attached. The
adhesive was cured per manufacture's instructions and the luer
fittings were screwed together.
[0148] The second linear actuator sub-assembly was made in the
following manner. The second linear actuator, flushing port,
flushing gasket retainer and silicone flushing gasket were
obtained. The flushing gasket was inserted into the back of the
second linear actuator with the u portion of the flushing gasket
facing distally. The flushing gasket retainer was fitted over the
top inside the second linear actuator. Cyanoacrylate glue was
applied around the gasket retainer to hold the gasket retainer in
place. The flushing port was placed into an aperture in the second
linear actuator and an U.V. cure adhesive was applied and cured
according to manufactures instructions.
[0149] A first tube was obtained and cyanoacrylate was applied to
the outside surface of the round I.D. section of the catheter in a
2.54 cm band from the end. The catheter was then inserted into the
distal end of the control shuttle until the catheter became flush
with the back of the control shuttle. The catheter was oriented so
that the two small lumens were horizontal and on the top portion of
the round lumen. The retrieval cord lock was snapped onto the
control shuttle.
[0150] The second tube sub-assembly was manufactured in the
following manner. A four inch piece of 0.033 mm diameter nitinol
wire was inserted into the second tube extrusion. The second tube
extrusion with wire insert was inserted into a hypotube. The distal
end of the hypotube was crimped by hand three times.
[0151] The distal end of the first tube was threaded through the
top of the mandrel control lever and through the top aperture on
the distal end of the mandrel control lever. The distal end of the
second tube was threaded into the proximal end of the control
catheter. The second tube was pushed into the first tube until
about 4 in. of hypotube were protruding from the end of the control
catheter. A cyanoacrylate adhesive was applied to the proximal end
of the hypotube over about a 12.7 mm section. This section was
inserted into the top aperture in the proximal end of the mandrel
control lever until flush with the back of the mandrel control
lever. The distal end of the first tube was then threaded into the
proximal end of the second linear actuator. The second linear
actuator was moved to the back most position on the control
catheter.
[0152] A sizing insert was then fitted into a left body shell. The
sizing insert was oriented so that the groove in the sizing insert
fit over the ridge in the left shell. The catheter sub assembly was
placed into the left body shell so that the mandrel control lever
fit into the sizing insert and the second linear actuator fit into
the slot in the distal end of the left body shell. A slider rod was
inserted through the openings in the sizing insert, mandrel control
lever, control shuttle and the second linear actuator. The slider
rod was made to rest on two supports in the left body shell. The
control spring was inserted into the right body shell so that it
fit into the opposing teeth. The right body shell was then placed
onto the left body shell and the two were snapped together. Two
screws (#4-24.times.1/2 in. thread-forming Pan Head) were inserted
into the available apertures on the left body shell and tightened.
The lock release actuator was snapped into place on the right tab
of the second linear actuator with a drop of cyanoacrylate adhesive
to ensure that it remained attached.
[0153] The second linear actuator, control shuttle, and the mandrel
control lever were moved to their forward most positions. The
second linear actuator was pulled back and then returned to its
forward position. The distal end of the first tube was trimmed by
hand with a razor blade to 1.27 mm measured from the tip of the
third tube. The sizing insert was pushed forward. The second tube
was trimmed by hand using a razor blade to a length of about 0.76
mm measured from the distal most end of the control catheter. An
about 4 inch long piece of nitinol wire (0.30 mm diameter) was
obtained. A cyanoacrylate adhesive was applied into the tip of the
second tube with an elongated applicator tip. The nitinol wire was
inserted into the tip of the locking and another piece of wire was
used to insert the nitinol wire about 2 mm into the second tube.
The cyanoacrylate adhesive was allowed to cure.
[0154] The second linear actuator was pulled back and a slot was
punched out of the control catheter. The slot had a width that was
about the same width as the small axis of the oval lumen of the
catheter. A razor was used to skive the slot to a final length of
about 19.05 mm. The second linear actuator and the sizing insert
were then moved to a forward position.
[0155] A retrieval cord approximately 3.05 m long (PTFE fiber with
a 0.25 mm O.D.) and a 1.52 m (0.15 mm O.D.) nitinol wire were
obtained. The nitinol wire was inserted into one of the 0.04 mm
lumens in the first tube and pushed through until it came out into
the handle. Tweezers were used to grasp the wire and pull it out of
the slot in the handle. About 76.2 mm of wire were made to protrude
from the distal end of the control catheter. A loop was formed in
the wire by inserting the loose end into the same lumen at the
distal end of the control catheter. About 76.2 mm of retrieval cord
was then threaded through the resulting loop. The nitinol wire was
pulled through the catheter until the retrieval cord protruded into
the handle.
[0156] A sealing device was obtained. A needle of a type commonly
used for sewing was threaded with the retrieval cord and the needle
was inserted through the PTFE bag opposite the lock loop and
through the lumen of the proximal eyelet of the sealing device. The
nitinol wire was then threaded through the remaining unoccupied
0.04 mm lumen in the first tube with the loop end of the wire
pointing distally. The needle was removed from the retrieval cord
and the cord was threaded through the loop on the nitinol wire. The
retrieval cord was then pulled through the catheter in the manner
described previously.
[0157] The control shuttle was retracted approximately 12.7 mm. The
second tube was then threaded through the eyelets of the device.
Tweezers were used to grasp the retrieval cord and pull in to the
outside of the handle. A loop was formed in a portion of small
diameter nitinol wire. The loop was inserted through an aperture in
the distal portion of the top of the control shuttle. The retrieval
cord was threaded through this loop and pulled through the aperture
in the distal portion of the control shuttle. The retrieval cord
lock was removed from the control shuttle and one free end of the
retrieval cord was inserted through the aperture in the retrieval
cord lock from the bottom. Four over hand knots were tied in the
cord. Excess cord was trimmed by hand and the retrieval cord lock
was returned to the control shuttle.
[0158] The remaining free retrieval cord was pulled until all slack
was gone. The remaining free end of the retrieval cord was inserted
into an aperture in the front of the top of the control shuttle.
The retrieval cord was pulled until taught and the retrieval cord
lock was snapped dosed. The cord was trimmed by hand to about 20.32
cm.
[0159] The second tube was flared by obtaining a soldering iron
with a sharp tip and heating it to about 500.degree. F. The tip of
the iron was inserted into the second tube until a flare was
created that was approximately 1.39 mm in diameter. The locking
loop on the device was chilled.
Example 4
Tear Drop
[0160] A length of 0.23 mm diameter nitinol wire (Fort Wayne
Metals, Fort Wayne, Ind.) was obtained. The specific length of the
wire was not measured, it is only necessary that the wire be long
enough to double through the feed holes described in the following
paragraph. The wire was obtained having been electro polished.
[0161] A base jig 8 as described in FIG. 17 was obtained. The base
jig was secured in a chuck of a lathe and center pin 22 was
inserted into center pin hole 24 far enough to securely seat it. A
knot was tied into one end of one length of a length of nitinol
wire and the unknotted end was fed through a wire feed hole 10. Two
additional lengths of nitinol wire were folded in half and the free
ends were fed through the remaining four feed holes 12, 14, 16, 18.
Weights 20 were attached to the free ends of the five wires to hold
the wires taut and in place.
[0162] The other end of center pin 22 was located inside the center
hole 28 of tail stock support 26 which was chucked into the tail
stock, wherein the closed face 30 of the tail stock support 26
faced the base jig 8. The base jig 8 and tail stock support 26 were
positioned about 5 cm apart. A wire guide 34 was used to prevent
the wires from crossing. The base jig 8 was positioned so that the
wire feed holes 10, 12, 14, 16, 18 were oriented vertically above
the center pin 22 and the wires were positioned on the trailing
side of the center pin 22. The wires were wrapped twice around the
center pin 22 and left to hang parallel to the wire feed holes.
[0163] The petal jig hole 36 was rotated 720.degree.. The petal jig
38 was inserted into the petal jig hole 36. Without crossing the
wires, the wires were wrapped counter clockwise around the petal
jig 38 past the tear drop pin 39 and around the circumference of
the tear drop pin 39. The wires were wrapped around the outer
circumference of the petal jig 38 to bring the wire between the
petal jig 38 and the center pin 22. They were then wrapped around
the center pin 22 twice.
[0164] The wires were placed under anchor plate 11. The anchor
plate 11 was secured with Allen head screws 14. The wires were cut
on the weight 20 side of the anchor plate 11.
[0165] With the weights 20, the tail stock support 26, and the wire
guide 34 removed, the assembly was placed in a convection oven set
to 475.degree. C. for 14 minutes. The assembly was removed from the
oven and quenched in water. The jigs were disassembled and the
article was removed.
[0166] The wire ends were trimmed to the eyelets and the petals
were fanned in the same direction as the helical winding, such that
each petal was oriented 72.degree. relative to the adjacent
petal.
[0167] The article was powder coated with FEP powder (obtained from
in house stock) in the following manner. A 2 mm outer diameter
steel hollow mandrel was obtained of sufficient length to hold the
article and have remaining length to extend into the commercial
blender. The mandrel was inserted into the center hole of the
article. One end the mandrel was grounded. A commercial blender
(Variable Speed Lab Blender, Waring, Torrington, Conn.) was
obtained and a quantity of FEP powder was added, leaving the tip of
the blender blades exposed. The article and mandrel were suspended
in the center of the blender, the lid was replaced, and the blender
was turned on to the highest setting for about 5 seconds. The
article and mandrel were removed, the mandrel was tapped to achieve
a more uniform powder coating, the powder coating was vacuumed from
the madrel and the article and mandrel were then hung inside a
convection oven set to 320.degree. C. for 3 minutes. The article
and mandrel were removed from the oven, allowed to cool, and excess
FEP was removed from the article, the mandrel was removed.
[0168] In a separate process a lock loop 43 (illustrated in FIG.
18A) was manufactured. The lock loop 43 was inserted through a
hypotube 45 (smaller than the ID of the eyelets) with the looped
end 47 of the lock loop 43 straightened. The hypotube 45 was
inserted through the eyelets from the distal end until lock loop
eyelet 49 is situated over the distal eyelet 608 of the device. The
hypotube was removed.
[0169] A crimped mandrel 41 (shown in FIGS. 18B and 18C) was
inserted into the article through the eyelets with the lock loop 43
along the outer length of the mandrel 41. The article was extended
in length on the mandrel by grasping the proximal and center
eyelets with tweezers. The eyelets were fixed in place by
positioning them beyond the crimps in the mandrel.
[0170] Next, a porous ePTFE film having the following properties
was obtained:
[0171] Methanol bubble point of 0.7 psi
[0172] Mass/area of 2.43 grams/square meter
[0173] Longitudinal matrix tensile strength of 96000 psi
[0174] Matrix tensile strength in the orthogonal direction of 1433
psi
[0175] Longitudinal maximum load of 1.6 kg/inch
[0176] Thickness of 0.00889 mm
[0177] Methanol bubble point is measured using a custom built
machine with a 1 inch diameter foot, a ramp rate of 0.2 psi/second
and a liquid media of methanol. Length and width of the material
are measured using a metal ruler. Mass/area is measured using a
balance (Model GF-400 Top Loader Balance, ANG, San Jose Calif.)
with a 36.times.5 inch sample. Longitudinal maximum load is
measured using a materials test machine (Model 5564, Instron, Grove
City, Pa.) equipped with a 10 kg load cell. The gauge length is
2.54 cm and the cross head speed is 25 mm/minute. Sample width is
2.54 cm. Longitudinal tensile test measurements are taken in the
length direction of the material. Thickness is measured using a
thickness gauge (Mitutoyo Digital Indicator 547-400) with a foot
diameter of 1/4 inch. The longitudinal matrix tensile strengths
(MTS) are calculated using the following equation: Density is
calculated using the formula, density=mass/volume as described in a
previous example.
[0178] A 30 mm film tube is constructed from the ePTFE material in
the following manner. For a 25 mm diameter device, a film with a
slit width of about 1.905 cm is wound on a 30 mm OD mandrel. The
amount of film overlap is not critical but no overlap of the edges
is unacceptable. The film tube is then removed from the mandrel and
stretched to make the ID of the tube to be about 25 mm. The film
tube was slipped over the tensioned article and using ePTFE film,
the ends of the tube were cinched around the center of the device
then the eyelets.
[0179] Another porous ePTFE film, having a layer of FEP, was
obtained having the following properties:
[0180] Mass/area of 36.1 grams/square meter
[0181] Maximum Load, Longitudinal of 12.6 kg/inch
[0182] Maximum Load, Transverse of 0.3 kg/inch
[0183] Thickness of 0.030 mm
[0184] Test methods for the above tests are described previously.
The FEP thickness in the film is about 62.5%. FEP thickness (%) is
calculated as ratio of the FEP thickness and the film thickness.
The reported value represents the average measurements for five
samples. FEP thickness and film thickness is measured from scanning
electron microscope images of cross sections of the ePTFE/FEP
laminate material in the following manner. The magnification is
chosen to enable the viewing of the entire film thickness. Five
lines perpendicular to the horizontal edge of the image are
randomly drawn across the full thickness of the film. Thickness is
determined by measuring the thickness of the FEP and the thickness
of the film.
[0185] A 2 mm wide strip of this FEP-coated ePTFE film, with the
FEP side down, was wrapped four times around the cinched portions
and heated with a soldering iron to bond the film layers
together.
[0186] The article and mandrel were placed inside a convection oven
set to 320.degree. C. for 3 minutes and then removed and allowed to
cool. The excess ePTFE material was trimmed and the article removed
from the mandrel.
Example 5
Long 5 Wire
[0187] An article was constructed in the same manner as example 1
with the following exceptions:
[0188] Instead of using petal jig 38, self centering petal jig 39
(FIG. 19) was used wherein jig 39 was placed over the center pin 22
and tail stock support 26 was introduced prior to wrapping the
first eyelet. After wrapping the first eyelet self centering petal
jig 39 was inserted into petal jig hole 36. The wire was wrapped
around the perimeter of petal jig 39 to form petals and wrapping
was continued around center pin 22 to create a second eyelet. A
fully extended final article of this example is shown in FIGS. 20A
and B.
Example 6
Long 10 Wire
[0189] An additional article 32 shown in FIG. 21 was constructed
using two intermediate (i.e., not powder coated) articles (one
inner and one outer) of example 5 wherein, the intermediate
articles were wrapped in opposite directions. Additionally the
inner intermediate article was manufactured such that the eyelets
of the inner intermediate article would fit within the eyelets of
the outer intermediate article. Prior to FEP coat, the inner and
outer intermediate articles were nested using the following
method:
[0190] In order to achieve nesting of the two intermediate
articles, the distal eyelets and the proximal eyelets must be
nested. Inner intermediate article was positioned at the end of a
straight, circular mandrel. One eyelet of the outer intermediate
article was positioned over an eyelet of the inner intermediate
article and both intermediate articles were repositioned to the
other end of the mandrel. The remaining eyelet of the outer
intermediate article was positioned over the remaining eyelet of
the inner intermediate article. They were arranged such that the
overlapping wires were equally spaced (about 72.degree. apart)
thereby creating a frame. The frame was subsequently FEP coated and
covered with an ePTFE bag in order to create the final article.
Example 7
Short 6 Wire
[0191] With the following exceptions, an article similar to that as
described in example 1 was created: A similar jig 50 illustrated in
FIG. 22B as previously described in example 1 was obtained. The
petal jigs 52 and waist jig 54 were positioned as shown in FIG.
22B. The wire wrapping process is shown in the wire path 56
depicted in FIG. 22B, wherein the wire starts at anchor points 57
and ends at eyelet pin 58 (not shown) that is inserted into eyelet
pin hole 59. The wire is wrapped 720.degree. around the eyelet pin
at the start of the device wrapping and at the finish of the device
wrapping. The fully extended final article 51 of this example is
shown in FIG. 22A.
Example 8
Short 12 Wire
[0192] An additional article (FIGS. 23A and 23B) was constructed
using two intermediate (i.e., not powder coated) articles (one
inner and one outer) of example 7 wherein, the intermediate
articles were wrapped in opposite directions. Additionally the
inner intermediate article was manufactured such that the eyelets
of the inner intermediate article would fit within the eyelets of
the outer intermediate article.
[0193] Prior to FEP coat, the inner and outer intermediate articles
were nested using the following method:
[0194] In order to achieve nesting of the two intermediate
articles, the distal eyelets and the proximal eyelets must be
nested. Inner intermediate article was positioned at the end of a
straight, circular mandrel. One eyelet of the outer intermediate
article was positioned over an eyelet of the inner intermediate
article and both intermediate articles were repositioned to the
other end of the mandrel. The remaining eyelet of the outer
intermediate article was positioned over the remaining eyelet of
the inner intermediate article. They were arranged such that, the
overlapping wires were equally spaced (about 72.degree. apart)
thereby creating a frame. The frame was subsequently FEP coated and
covered with an ePTFE bag in order to create the final article.
Example 9
Lock Loop Build
[0195] Wire was obtained as described in the previous examples. A
lock loop base jig 60 (FIG. 24A) with center pin 22 was placed in
custom stand as a manufacturing aid. A button component 62
configured such that the inner lumen is not round but is keyed to
keep from rotating on center pin was obtained. The wire was formed
into a loop and the loop was inserted through the lumen of the
button 62. The button with wire loop was threaded onto center pin
22 with loop toward the opposite side of center pin as the keyed
portion of the inner lumen of the button component. The keyed
portion of the button component 62 was situated to the right of the
lock loop base jig 60. A wire was chosen and bent toward the
builder then wrapped 360.degree. around the button component 62,
then wrapped around the center pin 22 for a minimum of four
revolutions and tied off after the fourth revolution. The wire
wraps should be spacing apart approximately 1 mm. Loop forming tool
64 (FIG. 24B) was inserted in lock loop base jig 200 against the
center pin 22. The free wire was wound about 370.degree. shaft 66
of loop forming tool 64 then wrapped around the pin 68 on the loop
forming tool 64 and anchored onto the lock loop base jig 60. The
base jig 60 and loop forming tool 64 were removed from the stand
and placed in an oven. The entire assembly was heated in an oven
such as described previously for 14 min. at 475.degree. C. The lock
loop was removed from the jig 60 and loop forming tool 64 and the
excess wire was trimmed.
Example 10
Space Filling Device
[0196] The following embodiments teach a heat set for the device
described in Example 7 prior to the application of the cover,
hereinafter called the frame of Example 7.
[0197] The frame of Example 7 was placed over about a 2 mm mandrel.
The mandrel 72 was crimped on both sides if the article in order to
secure it from moving. The frame was then placed on the tubular
cylinder 70 described in FIG. 25A such that the frame outer
perimeter rested on the upper edge of cylinder 70. Cap 74 was then
placed over the frame and cylinder 70 as shown in FIG. 25B and
secured in place via set screw 76. The entire assembly was then
placed in a forced air oven set to 475.degree. C. for 14 minutes.
The assembly was removed from the oven and quenched in room
temperature water. The frame 78 was subsequently FEP powder coated
as described in Example 2.
Example 11
Space Filling Anchors
[0198] The following embodiments teach an anchor means for the
device described Example 10.
[0199] (a) An anchor component 80 as shown in FIG. 26A was created
by the method as generally shown in FIG. 26B. The wire 82 of each
of the petals was cut at location 84 thereby eliminating the
remainder 86 of the length of the loop, resulting in anchor 80.
Anchor component 80 was next affixed to frame 78 as generally shown
in FIG. 26C. The spokes 82 of anchor 80 were aligned with the wires
of frame 78. A tape made from ePTFE film with a thin layer of FEP
was wrapped 88 around the wires 82 and the wires of frame 78 and
then heated to bond the wires together as shown in FIG. 27.
[0200] The article was powder coated with FEP powder as previously
described. The frame 78 was covered as previously described, after
which wires 82 were individually manipulated to protrude through
the sealing member 106 as shown in FIG. 28.
[0201] (b) In another embodiment, the anchor component 80 of
Example 11 (a) was further modified as follows. Jig 90 and washer
92, as shown in FIGS. 29A and 29B, respectively, were obtained. The
anchor component 80 was inserted, eyelet down into jig 90, such
that eyelet of 80 was located inside hole 91 and the wires 82 were
located inside grooves 95 of jig 90. Washer 92 was placed on top of
anchor component 80 to hold it in place and the washer 92 was
secured with screw 323 in hole 94, as shown in FIGS. 29A-29C, which
caused the points of the wire 82 to orient toward the face of the
washer.
[0202] (c) In another embodiment, the anchor component 80 (shown in
FIG. 30) is manufactured as follows:
[0203] An about 1 meter length of 10% platinum drawn filled nitinol
wire. (Fort Wayne Metals, Fort Wayne, Ind.) with a diameter of
about 0.23 mm is obtained. The specific length of the wire is not
measured, it is only necessary that the wire be long enough to
complete the winding pattern as described in the following
paragraph. The wire is obtained having been electropolished.
Electropolishing nitinol wire imparts certain well known
properties, such as spontaneously forming a titanium dioxide layer
on the surface, selectively reducing the amount of nickel on the
surface of the wire, and removing some of the stresses in the wire
thus improving fatigue.
[0204] A base jig 8 as described in FIG. 17 is obtained. A knot is
tied into one end of one length of an about 0.5 meter long wire and
the unknotted end is fed through a wire feed hole 10. Two
additional lengths of wire (about 1 meter each) are folded in half
and the free ends are fed through the remaining four feed holes 12,
14, 16, 18, with the wire entering the holes at funnel-shaped
opening 19 (not shown) with the small feed holes at the bottom of
opening 19. The wires then exit through holes 10, 12, 14, 16 and 18
at the flat end surface of jig 8. Weights 20 are attached to the
free ends of the five wires to hold the wires taut and in place.
The base jig is secured in a chuck of a lathe and center pin 22 is
inserted into center pin hole 24 far enough to securely seat
it.
[0205] The other end of center pin 22 is located inside the center
hole 28 of tail stock support 26 which is chucked into the tail
stock, wherein the closed face 30 of the tail stock support 26
faces the base jig 8. The base jig 8 and tail stock support 26 are
positioned about 5 cm apart. A wire guide 34 is used to prevent the
wires from crossing. The base jig 8 is positioned so that the wire
feed holes 10, 12, 14, 16, 18 are oriented vertically above the
center pin 22 and the wires are positioned on the trailing side of
the center pin 22.
[0206] The petal jig hole 36 is rotated 720.degree.. The petal jig
38 is inserted into the petal jig hole 36. Without crossing the
wires, the wires are placed on top of the petal jig 38. The base
jig 8 is rotated 360.degree. to create the petals of the device.
The base jig 8 is rotated another 720.degree. with the wires placed
on top of the center pin 22.
[0207] With the weights 20, the tail stock support 26, and the wire
guide 34 removed, the assembly is placed in a convection oven set
to 475.degree. C. for 14 minutes. The assembly is removed from the
oven and quenched in water. The jigs are disassembled and the
article is removed. The wire ends are trimmed to the eyelets and
the anchor loops are fanned in the same direction as the helical
winding, such that each anchor loop is oriented 72.degree. offset
relative to the adjacent anchor loops. The anchor loops are crimped
at the center by hand and heat set again as previously
described.
[0208] (d) In another embodiment, anchor components are
manufactured by clipping about 2 cm straight lengths of nitinol
wire 71. A tape made from ePTFE film with a thin layer of FEP is
wrapped 88 around the wires 71 and the wires of frame 78 and then
heated to bond the wires together as shown in FIG. 31.
Example 12
Space Filler with 2 Planes of Anchoring
[0209] A device as previously described in Example 10 with anchors
as described in example 11(d) is manufactured by attaching the
anchors at multiple locations along the wires of frame 78.
[0210] In addition to being directed to the teachings described
above and claimed below, devices and/or methods having different
combinations of the features described above and claimed below are
contemplated. As such, the description is also directed to other
devices and/or methods having any other possible combination of the
dependent features claimed below.
[0211] Numerous characteristics and advantages have been set forth
in the preceding description, including various alternatives
together with details of the structure and function of the devices
and/or methods. The disclosure is intended as illustrative only and
as such is not intended to be exhaustive. It will be evident to
those skilled in the art that various modifications may be made,
especially in matters of structure, materials, elements,
components, shape, size and arrangement of parts including
combinations within the principles of the invention, to the full
extent indicated by the broad, general meaning of the terms in
which the appended claims are expressed. To the extent that these
various modifications do not depart from the spirit and scope of
the appended claims, they are intended to be encompassed
therein.
* * * * *