U.S. patent application number 12/353781 was filed with the patent office on 2009-05-14 for stent designs which enable the visibility of the inside of the stent during mri.
This patent application is currently assigned to BOSTON SCIENTIFIC SCIMED, INC.. Invention is credited to James Heggestuen, Thomas J. Holman, Jan Weber.
Application Number | 20090125099 12/353781 |
Document ID | / |
Family ID | 34116368 |
Filed Date | 2009-05-14 |
United States Patent
Application |
20090125099 |
Kind Code |
A1 |
Weber; Jan ; et al. |
May 14, 2009 |
STENT DESIGNS WHICH ENABLE THE VISIBILITY OF THE INSIDE OF THE
STENT DURING MRI
Abstract
A medical device that inhibits distortion of medical resonance
images taken of the device. In particular, various structures are
utilized to allow visibility proximate, and inside of, a tubular
member, such as a stent. In one embodiment, the stent is
constructed such that any closed path encircling at least a
circumference of the stent will pass through at least two materials
to reduce or eliminate electrical loops formed in the stent.
Inventors: |
Weber; Jan; (Maastricht,
NL) ; Holman; Thomas J.; (Princeton, NM) ;
Heggestuen; James; (Stillwater, NM) |
Correspondence
Address: |
FISH & RICHARDSON PC
P.O. BOX 1022
MINNEAPOLIS
MN
55440-1022
US
|
Assignee: |
BOSTON SCIENTIFIC SCIMED,
INC.
Maple Grove
MN
|
Family ID: |
34116368 |
Appl. No.: |
12/353781 |
Filed: |
January 14, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10636063 |
Aug 7, 2003 |
7479157 |
|
|
12353781 |
|
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Current U.S.
Class: |
623/1.34 ;
623/1.15 |
Current CPC
Class: |
A61F 2002/91533
20130101; A61F 2/91 20130101; A61F 2250/0043 20130101; A61F
2210/0076 20130101; A61F 2/915 20130101; A61F 2002/91575 20130101;
A61F 2250/0045 20130101; A61F 2250/0091 20130101 |
Class at
Publication: |
623/1.34 ;
623/1.15 |
International
Class: |
A61F 2/06 20060101
A61F002/06 |
Claims
1. A medical device for use within a body cavity, the medical
device having a visualization region in which visualization using
magnetic resonance imaging (MRI) is desired, the medical device
comprising: structural material defining a primary structure having
a wall with openings therein and a periphery, the structural
material being configured such that any closed path, in the
visualization region, extending about at least one of the periphery
or an opening in the wall, passes through at least two
materials.
2. The medical device of claim 1 wherein the primary structure
comprises a generally tubular structure which comprises: a
plurality of electrically conductive structural members; and a
plurality of bridges coupled to and forming electrical
discontinuities in the plurality of electrically conductive
structural members, the electrical discontinuities being sufficient
to enable MRI visualization in the visualization region.
3. The medical device of claim 2 wherein the plurality of
electrically conductive structural members are arranged as a
plurality of electrically conductive cells that define the openings
in the wall.
4. The medical device of claim 3 wherein each of the plurality of
conductive cells is coupled to at least one of the plurality of
bridges such that any closed path defining the cell in the
visualization region passes through the at least one bridge,
inhibiting formation of an electrical loop in the visualization
region.
5. The medical device of claim 4 wherein the plurality of
electrically conductive structural members further include a
plurality of electrically conductive connectors, with each of the
plurality of connectors connecting at least two of the plurality of
cells.
6. The medical device of claim 5 wherein each of the plurality of
connectors is coupled to at least one of the plurality of bridges,
thereby preventing an electrical loop being formed between two or
more cells across at least one of the plurality of connectors.
7. The medical device of claim 2 wherein the plurality of bridges
comprise a ceramic material.
8. The medical device of claim 2 wherein the plurality of bridges
comprise a polymeric material.
9. The medical device of claim 2 wherein the plurality of bridges
comprise an electrically non-conductive cement.
10. The medical device of claim 2 wherein the plurality of bridges
comprise an electrically non-conductive adhesive.
11. The medical device of claim 2 wherein each of the plurality of
electrically conductive structural members comprise a substantially
low magnetic susceptibility material.
12. The medical device of claim 11 wherein the substantially low
magnetic susceptibility material is at least one of platinum,
iridium, tantalum, titanium, niobium, hafnium and gold.
13. The medical device of claim 2 and further comprising a coating
of electrically insulating material covering at least portions of
the plurality of electrically conductive structural members which
are immediately adjacent to the bridges.
14. The medical device of claim 13 wherein the insulating material
is a polymeric material.
15. The medical device of claim 13 wherein the insulating material
is a ceramic material.
16. The medical device of claim 2 wherein the plurality of bridges
are formed in portions of the medical device which exhibit lower
tensile stress, when the medical device is extended, relative to
other portions of the medical device.
17. The medical device of claim 2 wherein the plurality of
electrically conductive structural members comprise a
metal/ceramic/metal layered structure.
18. The medical device of claim 17 wherein the plurality of bridges
comprise one or more slits formed in metal layers of the
metal/ceramic/metal layered structure.
19. The medical device of claim 18 wherein the slits are not formed
in the ceramic layer of the metal/ceramic/metal layered
structure.
20. The medical device of claim 18 and further comprising an
electrically isolating layer formed on the metal layers and in the
slits.
21. The medical device of claim 18 wherein for each of the
plurality of electrically conductive structural members, a slit
formed in a first metal layer of the layered structure is spaced
apart from a slit formed in a second metal layer of the layered
structure, such that at every position along a length of the
electrically conductive structural member, the structural member
includes the ceramic layer and at least one of the metal
layers.
22. The medical device of claim 2 and further comprising a
plurality of sleeves, with each of the plurality of sleeves
positioned over one of the plurality of bridges and overlapping
with adjacent portions of a corresponding electrically conductive
structural member.
23. The medical device of claim 1 wherein the primary structure
comprises a generally tubular structure comprising: a plurality of
hoop structures, each hoop structure having a section formed of a
material which prevents the hoop structure from forming a closed
electrical loop; and a backbone structure connected to each of the
plurality of hoop structures.
24. The medical device of claim 23 wherein the backbone structure
is a single continuous backbone.
25. The medical device of claim 23 wherein the backbone structure
includes a plurality of staggered backbone sections.
26. The medical device of claim 25 wherein the section of each hoop
structure is oriented in a different direction than the section of
an adjacent hoop structure.
27. The medical device of claim 1 wherein the primary structure
further comprises: a stent skeleton structure; and a reinforcement
structure embedded within the stent skeleton structure.
28. The medical device of claim 27 wherein the stent skeleton
structure comprises at least one of carbon composite, crystalline
graphite, and amorphous carbon.
29. The medical device of claim 27 wherein the reinforcement
structure comprises at least one of tantalum and platinum.
30. A medical device for use within a body cavity, comprising: a
primary structure formed of a plurality of substructures, the
substructures forming a wall of the primary structure and defining
openings in the wall, the primary structure having a visualization
region in which magnetic resonance imaging (MRI) visualization of
the body cavity adjacent the visualization region is desired, the
substructures in the visualization region being formed with
sufficiently low magnetic susceptibility material that the body
cavity adjacent the visualization region can be seen using MRI.
31. The medical device of claim 30 wherein the medical device
comprises a stent and wherein the substructures comprise connected
cells.
32. The medical device of claim 31 wherein each of the cells in the
visualization region has a portion thereof formed of the
sufficiently low magnetic susceptibility material.
33. The medical device of claim 30 wherein the primary structure
comprises a tubular structure.
34. The medical device of claim 31 wherein the substructures in the
visualization region form a periphery about the tubular
structure.
35. The medical device of claim 34 wherein the substructures
defining the periphery of the tubular structure in the
visualization region are formed with sufficiently low magnetic
susceptibility material that the body cavity adjacent the
visualization region can be seen using MRI.
36. A stent for use in a body cavity, comprising: a primary
structure formed of a plurality of substructures, the substructures
forming a wall of the primary structure and defining openings in
the wall, the primary structure having a visualization region in
which magnetic resonance imaging (MRI) visualization of the body
cavity adjacent the visualization region is desired, the
substructures in the visualization region being formed with
sufficiently low magnetic susceptibility material that the body
cavity adjacent the visualization region can be seen using MRI.
37. The stent of claim 36 wherein the substructures comprise
connected cells.
38. The stent of claim 37 wherein each of the cells in the
visualization region has a portion thereof formed of the
sufficiently low magnetic susceptibility material.
39. The stent of claim 36 wherein the primary structure comprises a
tubular structure.
40. The stent of claim 39 wherein the substructures in the
visualization region form a periphery about the tubular
structure.
41. The stent of claim 40 wherein the substructures defining the
periphery of the tubular structure in the visualization region are
formed with sufficiently low magnetic susceptibility material that
the body cavity adjacent the visualization region can be seen using
MRI.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates generally to devices for use
in vascular treatments. More particularly, the present invention
relates to devices used in vascular treatments that incorporate a
magnetic resonance visibility enhancing structure, the devices
being adapted for use in magnetic resonance imaging.
[0002] Vascular stents are known medical devices used in various
vascular treatments of patients. Stents commonly include a tubular
member that is moveable from a collapsed, low profile, delivery
configuration to an expanded, deployed configuration. In the
expanded configuration, an outer periphery of the stent
frictionally engages an inner periphery of a lumen. The deployed
stent then maintains the lumen such that it is substantially
unoccluded and flow therethrough is substantially unrestricted.
However, various stent designs substantially distort the
surrounding of the stent during a Magnetic Resonance Imaging
procedure.
[0003] Magnetic Resonance Imaging (MRI) is a non-invasive medical
procedure that utilizes magnets and radio waves to produce a
picture of the inside of a body. An MRI scanner is capable of
producing pictures of the inside of a body without exposing the
body to ionizing radiation (X-rays). In addition, MRI scans can see
through bone and provide detailed pictures of soft body
tissues.
[0004] A typical MRI scanner includes a magnet that is utilized to
create a strong homogeneous magnetic field. A patient is placed
into or proximate the magnet. The magnetic field causes a small
majority of the atoms with a net magnetic moment, also referred to
as spin, to align in the same direction as the magnetic field. When
a radio wave is directed at the patient's body, atoms precessing in
the magnetic field with a frequency equal to the radiowave are able
to adapt the radiowave energy, which causes them to "tumble over"
and align in the opposite direction of the magnetic field. The
frequency at which atoms with a net spin precess in a magnetic
field is also referred to as the Larmor frequency. The opposing
alignment is at a higher energy level compared to the original
orientation. Therefore, after removing the radiowave, atoms will
return to the lower energetic state. As the atoms return to the
lower energetic state, a radio signal is sent at the Lamor
frequency. These return radio waves create signals (resonance
signals) that are detected by the scanner at numerous angles around
the patient's body. The signals are sent to a computer that
processes the information and compiles an image or images.
Typically, although not necessarily, the images are in the form of
2-dimensional "slice" images.
[0005] An ability to effectively view areas proximate a stent
during an MRI procedure is desirable. In particular, viewing areas
inside and proximate a tubular member of a stent may be desirable
both during deployment and after deployment of the stent in a
patient. However, various current stent designs prevent adequate
imaging of the area surrounding the stent. Instead, the images are
distorted and thus cannot be used.
[0006] The visibility of the inside of current stent designs during
MRI procedures is blocked for two reasons. First of all, the
permanent influence of the surrounding magnetic field by stents
containing ferromagnetic materials prevents adequate imaging. A
second reason that adequate imaging of the area inside the stent is
blocked relates to induction currents (Eddy currents), induced in
the closed cell metal stent structure due to the changes in the
magnetic field generated by the MRI system during image sequencing.
The result is that the MR visibility of the inside of the stent is
shielded.
[0007] It is possible to build a stent out of polymer or other
non-conducting materials such as ceramics. Building stents out of
such non-conducting materials would avoid either of these MR
artifacts. However, stents made from materials such as these would
require larger strut dimensions to maintain adequate stent
mechanical performance as compared to stents made of metals.
[0008] The present invention addresses at least one of these or
other problems, and/or offers other advantages over the prior
art.
SUMMARY OF THE INVENTION
[0009] Embodiments of the present invention relate to medical
devices that reduce the distortion of medical resonance images
taken of the devices. In particular, various structures are
utilized to enhance visibility proximate and inside of a tubular
member of a stent. In one particular embodiment, the stent is
constructed such that any closed path encircling at least a
circumference of the stent will pass through at least two materials
to reduce or eliminate electrical currents formed in the stent as a
result of changing electromagnetic fields passing through the
stent.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a partial block diagram of an illustrative
magnetic resonance imaging system.
[0011] FIG. 2 is an illustration of a coil in a changing magnetic
field.
[0012] FIG. 3 is a diagrammatic side view of a portion of a stent
showing a cell and connector structure.
[0013] FIG. 4 is a block diagram illustrating a method of the
present invention.
[0014] FIGS. 5A-5G are diagrammatic side view illustrations
demonstrating implementation of the method shown in FIG. 4 in one
particular embodiment.
[0015] FIGS. 6A and 6B are diagrammatic top and side views,
respectively, illustrating one particular embodiment of a ceramic
or other non-conducting connector in a stent.
[0016] FIG. 7A is a diagrammatic illustration of a metal/ceramic
connector which can be used in embodiments of the invention.
[0017] FIG. 7B illustrates portions of two cells or rings of a
stent, mechanically separated and mechanically connected,
respectively, using a connector such as illustrated in FIG. 7A.
[0018] FIG. 8 is a perspective view of a portion of a stent in
which first and second metallic portions are connected together and
separated by an electrically non-conductive adhesive or cement.
[0019] FIG. 9 is a perspective view illustrating a portion of a
stent in which first and second metallic stent portions are
connected together using a ceramic connector.
[0020] FIGS. 10A-10C are perspective views of a portion of a stent
which illustrate a process for forming a ceramic connector between
first and second metallic portions of the stent.
[0021] FIGS. 11A-11C are perspective views of a portion of a stent
which illustrate an alternate method of forming a ceramic connector
between first and second metallic portions of the stent.
[0022] FIG. 12 is a plot illustrating tensile stress, for one
particular type of stent, which indicates high and low tensile
stress locations when one design embodiment of the stent is fully
expanded.
[0023] FIGS. 13A-13C are diagrammatic views of a portion of a stent
which illustrates an alternate method of eliminating electrical
loops in the stent.
[0024] FIG. 14 is a diagrammatic side view of a portion of a stent
illustrating a structure which eliminates electrical loops in an
alternate embodiment.
[0025] FIG. 15 is a diagrammatic side view of a portion of a stent
illustrating alternating metal sections and non-conducting
connector sections;
[0026] FIG. 16 is a diagrammatic side view of a portion of a
metallic stent including a plurality of electrically non-conducting
connectors, in accordance with various embodiments of the present
invention, in order to eliminate electrical loops formed in the
stent.
DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0027] FIG. 1 is a partial block diagram of an illustrative
magnetic resonance imaging system. In FIG. 1, subject 100 on
support table 110 is placed in a homogeneous magnetic field
generated by magnetic field generator 120. Magnetic field generator
120 typically comprises a cylindrical magnet adapted to receive
subject 100. Magnetic field gradient generator 130 creates magnetic
field gradients of predetermined strength in three mutually
orthogonal directions at predetermined times. Magnetic field
gradient generator 130 is illustratively comprised of a set of
cylindrical coils concentrically positioned within magnetic field
generator 120. A region of subject 100 into which a device 150,
shown as a stent, has been inserted, is located in the body of
subject 100.
[0028] RF source 140 radiates pulsed radio frequency energy into
subject 100 and stent 150 at predetermined times and with
sufficient power at a predetermined frequency to influence nuclear
magnetic spins in a fashion known to those skilled in the art. The
influence on the spins causes them to position anti-parallel to the
main magnetic field when the radio frequency equals the Larmor
frequency of the atoms, allowing them to accept the radio energy.
As atoms can only accept radio energy when the radio frequency
equals their Larmor frequency, which is directly related to
absolute magnetic field strengths, one is able to selectively
change the net-spin of only certain regions by using additional
gradient magnetic fields. The Larmor frequency for each spin is
directly proportional to the absolute value of the magnetic field
experienced by the atom. This field strength is the sum of the
static magnetic field generated by magnetic field generator 120 and
the local field generated by magnetic field gradient generator 130.
In an illustrative embodiment, RF source 140 is a cylindrical
external coil that surrounds the region of interest of subject 100.
Such an external coil can have a diameter sufficient to encompass
the entire subject 100. Other geometries, such as smaller cylinders
specifically designed for imaging the head or an extremity can be
used instead. Non-cylindrical external coils such as surface coils
may alternatively be used.
[0029] External RF receiver 160 illustratively detects RF signals
emitted by the subject in response to the radio frequency field
created by RF source 140. In an illustrative embodiment, external
RF receiver 160 is a cylindrical external coil that surrounds the
region of interest of subject 100. Such an external coil can have a
diameter sufficient to encompass the entire subject 100. External
RF receiver 160 can share some or all of its structure with RF
source 140 or can have a structure entirely independent of RF
source 140. The region of sensitivity of RF receiver 160 is larger
than that of the stent 150 and can encompass the entire subject 100
or a specific region of subject 100. The RF signals detected by
external RF receiver 160 are sent to imaging and tracking
controller unit 170 where they are analyzed. Controller 170
displays signals received by RF receiver 160 on visual display
190.
[0030] Establishing a homogenous, or uniform, magnetic field with
magnetic field generator 120 in addition to switched linear
gradient magnetic fields activated in various sequences as well as
timely switching the RF radiowave in various sequences, as known in
the art, enables the production of internal images of subject 100.
It is common that the magnetic field surrounding stent 150 is
distorted, which causes distortion of images obtained proximate
stent 150. This is because the magnetic field distortion due to the
ferromagnetic components will change the absolute magnetic field
proximate to the stent causing in effect shifts in the Larmor
frequencies which changes the interaction with the RF-field
(amplifies, reduces or even eliminates the interaction). For
example, it is common for the material and structure of stent 150
to affect the magnetic field around stent 150. Such effects reduce
the influence that magnetic field generator 120, gradient generator
130 and RF source 140 have on the nuclear magnetic spins in subject
100. In particular, the spins inside a tubular member of a stent
are commonly not excited during an MRI and thus no image is
detected.
[0031] One embodiment of the present invention includes using
non-ferromagnetic materials in stent 150 to reduce this distortion.
Such materials include, by way of example, platinum, iridium,
tantalum, titanium, gold, niobium, hafnium alloys exhibiting
non-ferromagnetic properties, and other non-ferromagnetic
materials. Combinations of ferromagnetic and non-ferromagnetic
materials and/or non-metal material can also be utilized without
departing from the scope of the present invention.
[0032] Another effect that commonly distorts the magnetic field
around an intravascular device is associated with Faraday's Law.
Faraday's Law simply states that any change in a magnetic
environment of a coil will cause a voltage (emf) to be "induced" in
the coil. Stent 150 can act as a coil when implanted in a subject
during an MRI process. The change in magnetic environment is caused
either by stent 150 moving or rotating within a nonuniform magnetic
field, or by changes in the magnetic field proximate stent 150. For
example, stent 150 may move due to the heart beating or magnetic
field changes may be induced by gradient generator 130 or RF Source
140.
[0033] According to Faraday's Law, the induced emf in a coil is
equal to the negative of the rate of change of magnetic flux
through the coil times the number of turns in the coil. When an emf
is generated by a change in magnetic flux, the polarity of the
induced emf produces a current creating a magnetic field that
opposes the change which produces it. Accordingly, the induced
magnetic field inside any loop of wire acts to keep the magnetic
flux inside the loop constant. In the case of a metallic stent,
where each individual ring or cell, or combinations of cells, can
act as a coil, the visibility within and around or adjacent the
stent using an MRI can be blocked.
[0034] FIG. 2 further illustrates this effect. Coil 200 has been
placed in a magnetic field produced by magnet 202. The magnetic
field is represented by a vector B. Any change in magnetic field B,
herein represented as .DELTA.B, causes a current, represented as
arrow 204, to be produced in coil 200. Current 204 causes a
magnetic field B.sub.I to be induced, which opposes the change
.DELTA.B.
[0035] When attempting to produce an image of stent 150 inside
subject 100, some stents act as a coil or, depending on the
structure of the stent, as multiple coils. During various phases of
an MRI process to influence the nuclear spins, a change in the
magnetic field inside the stent is generated. For example, gradient
generator 130 may generate a pulse in order to influence spins to
be analyzed by controller 170. The gradient generator 130 thus
changes the magnetic field and accordingly a change in magnetic
field proximate the stent is opposed by Faraday's Law. As a result,
spins proximate the stent are not excited and images of the stent
show a lack of signal.
[0036] In order to reduce the effect of Faraday's Law on spins
inside the stent loops or the main stent tube, various stent
designs have been made in accordance with embodiments of the
present invention. In some embodiments, the creation of electrical
loops within a stent structure is avoided by eliminating electrical
loops within the cells or rings of the stents. These embodiments
are described below with reference to various examples. However,
the invention is not limited to these examples. Using these
designs, the visibility of a stent during an MRI process is
enhanced by removal of the desired artifacts.
[0037] Referring now to FIG. 3, illustrated is a portion of a stent
300 which can be one embodiment of stent 150 shown in FIG. 1. As
shown diagrammatically in FIG. 3, stent 300 includes a plurality of
cells (sometimes referred to as struts, bands or rings) 302 which
are connected together using a plurality of connectors (sometimes
referred to as bridges or links) 304. The cells 302 are wrapped
around a central axis (not shown) to form a generally tubular
structure. Cells 302 and/or connectors 304 can be made of a
material that is substantially non-ferromagnetic. When expanded,
cells 302 and connectors 304 frictionally engage an inner periphery
of a lumen when a tubular structure of stent 300 is opened to
support the anatomy. Although cells 302 and connectors 304 can be
made of a non-ferromagnetic material to reduce the permanent
influence on the surrounding magnetic fields, if cells 302 are made
from electrically conductive material, each cell 302 can
circumferentially form a closed electrical loop. Closed electrical
loops act as coils and negatively impact the visibility of a region
proximate the inside of the stent during an MRI. Multiple loops can
be laterally or longitudinally formed, with a single electrical
loop sometimes traversing multiple cells 302 via connectors
304.
[0038] This problem can be overcome by constructing the stent using
non-ferromagnetic metals (i.e., having low magnetic susceptibility)
to overcome the first mentioned hurdle, and to include electrically
non-conducting portions within each cell 302 to overcome the issue
of induction currents by eliminating electrical loops formed
circumferentially within the cells. The electrically non-conducting
portions can also be included within specific connectors 304 to
eliminate closed electrical loops longitudinally traversing
multiple cells 302. In some embodiments, further operational
enhancement is achieved by including an isolating coating around at
least some necessary metal parts of the stent to eliminate any
problematic electrical bridge through the surrounding media (e.g.,
blood).
[0039] FIG. 4 is a block diagram illustrating a general method of
producing stents which enable the visibility of the inside of the
stent during MRI. Using this method, a metal stent is obtained as
is shown in step 310. Then, portions of the stent are replaced with
electrically non-conductive bridges to reduce or minimize the
electrical loops formed in the stent. This is illustrated at step
320 in FIG. 4. In some embodiments, these steps are used to create
stents in which any closed path encircling at least the
circumference of the stent will pass through at least two
materials. If at least one of the materials is electrically
non-conductive, electrical currents will be reduced or eliminated.
The present invention is not limited to this particular method, and
includes, for example, methods of forming stents which do not alter
an existing metallic stent.
[0040] In various embodiments of the invention, step 320 of
replacing portions of the stent with electrically non-conductive
bridges includes replacing at least a portion of each cell 302 with
the electrically non-conductive struts to eliminate closed
electrical loops formed by each individual cell. In some
embodiments, step 320 further includes replacing portions of each
connector 304 with electrically non-conductive bridges to eliminate
closed electrical loops formed between cells 302 in the stent.
Various more specific methods of fabricating stents in accordance
with the method shown in FIG. 4 are described below. Further, other
methods can be used to produce stents in accordance with the
invention in which any closed path encircling at least the
circumference of one cell will pass at least through two
materials.
[0041] In some embodiments of the invention, the electrically
non-conductive struts placed or formed in the cells 302 and
connectors 304 are ceramic struts or bridges, respectively. A
typical example of the use of a strong ceramic material in the
human body in combination with a metal structure is the case of
dental crowns. In that example, the connection between the metal
and the porcelain is made by applying ceramic powder (Frit), with
water or other liquid in slurry form. The liquid is evaporated and
the assembly is fired at high temperature where frit is scintered
into a solid ceramic with a strong bond to the metal base. Another
technique for example is referred to as "press to metal". In that
example the connection between the metal base structure with wax in
the shape of a tooth and channels to direct the flow of molten
ceramic in a mold (for example, phosphate bonded silica). Wax is
eliminated to form a negative mold and ceramic ingots are molted
and pressed into the mold. When cooled the solid ceramic with
strong bond to metal base structure is divested with media
blasting.
[0042] This type of process can be adapted to produce stents having
ceramic bridges, for example as follows. In one embodiment, this
type of process begins with obtaining a metal stent as was
illustrated at step 310 in FIG. 4. In other words, a metal stent
could be produced in a conventional fashion, including the
lasercutting and electropolishing steps. Then, as illustrated in
FIG. 5A, the stent 300 (only a portion of which is shown for sake
of clarity) is positioned in a polymer or Teflon tube 350 (shown
diagrammatically in cross-section in FIG. 5A) having an inner
diameter which is only slightly larger than the outer diameter of
the stent 300. The tube 350 is then filled with a material which
hardens around stent 300. For example, the tube can be filled with
an investment casting material (such as phosphate-bonded silica or
gypsum solution), and subsequently dried or baked to solidify the
gypsum around stent 300. Prior to hardening the gypsum or other
tube filling material, a central corewire 355 can be placed on the
central longitudinal axis of stent 300 to reinforce the gypsum
structure and to provide a positioning device for subsequent laser
cutting steps. Removal of the tube 350 leaves a solid gypsum rod
360 with the outer surface of the stent covered with a thin layer
359 of gypsum as is shown in FIG. 5B.
[0043] Next, a laser cutting process is used to cut through
specific portions of cells 302 and connectors 304. The cuts or
slits in the cells 300 are shown in FIG. 5C and are designated with
reference number 361. The cuts or slits in the connectors 304 are
also shown in FIG. 5C and are designated generally by reference
number 362. The cuts 361 in cells 302, and the cuts 362 in
connectors 304, are made in places where ceramic connectors or
bridges are to be formed. The laser cutting process is also used to
produce openings where mechanical connections are to be formed for
the ceramic in both sides of the slits 361, 362. FIG. 5D
diagrammatically illustrates that the laser cutting process not
only cuts away the gypsum in the area that defines the slit 361,
but it also cuts away an area around slit 361. These exposed areas
or openings on either side of slit 361 are referred to as openings
363 and they expose an area where mechanical connections are to be
formed. These openings 363 are formed around each of slits 361, 362
in the cells and connectors.
[0044] Since the stent is embedded in the gypsum rod, the remaining
structure is supported and kept in place by the gypsum. The
optional central core wire 355 can also be included to reinforce
this structure. Further, wire 355 can be used to precisely position
the stent relative to the laser beam during the cutting process in
which slits 361, 362 are formed.
[0045] The remaining stent structure no longer has any closed
electrical loops. It would be difficult, if possible at all, to
laser cut the stent in this manner prior to molding it inside the
gypsum (or other material), since disconnecting all electrical
loops would also result in disconnecting all mechanical structures.
To cut through the desired portions 361, 362 of the stent and the
outer layer of gypsum, an ultrashort pulsed laser (e.g., in a range
of femto-seconds or atto-seconds) can be used in one embodiment.
This type of laser is capable of ablating any type of material
without significant debris. Because the stent is covered by the
gypsum, any debris that does result will settle on the gypsum
layer, and not on a stent surface.
[0046] A next step is to fill the cut slits 361, 362 with wax, and
to connect all different wax spots to a central wax channel by
making small wax lines on the outside of the gypsum rod 360. FIG.
5E illustrate two such wax lines 370 on the outside of the gypsum
rod 360. Next, this assembly is covered by a second gypsum layer
380 (shown in FIG. 5F) using any of a variety of techniques. For
example, the gypsum rod 360 including wax lines 370 aligned with
slits 361, 362 can be again placed in a tube having a slightly
larger diameter, providing a structure which would allow the second
gypsum layer 380 to harden. Other techniques could be used as
well.
[0047] When drying and baking the second layer of gypsum, the wax
370 is removed, leaving open channels 385 (shown in FIG. 5F) where
the wax was located. This process is herein referred to as the lost
wax method. Although two wax lines 370 are shown in FIG. 5E, and
only three open channels 385 are shown in FIG. 5F, those of skill
in the art will recognize that such illustration is for purposes of
clarity, and that additional wax lines and channels would be
formed, corresponding to the various different positions of slits
361, 362 in stent 300.
[0048] After forming channels 385 using this process, ceramic (for
example porcelain) powder material is injected in solution through
the lost wax channels 385. The entire assembly is then fired to
turn the ceramic fluid into a ceramic structure. After cooling, the
gypsum mold, which is very brittle, can be removed. The fine
ceramic wires formed in channels 385 are separated. Finally, the
ceramic connectors 390 (shown in FIG. 5G) which remain can be
polished. It can be worthwhile to use low-firing temperature
ceramics, since these are designed to be very polishable. Polishing
can be done using normal instrumentation of the type used in dental
labs. Any excess gypsum can be removed using a washing, etching or
blasting step. The stent can be polished before this process.
However, regions to be reconnected may need chemical etching,
mechanical blasting or other appropriate surface treatment to
increase bond strength. Alternate processing can include starting
with a bare tube, placing ceramic connectors or media in a
predetermined location or hole and firing or curing the ceramic,
and finally laser cutting the stent pattern. This can be done with
multi-layer tubes. To provide a robust connection between the metal
and the ceramic, special structures can be incorporated in the
stent design during the laser cutting of the slits 361, 362. For
example, a structure like the one shown in FIGS. 6A (top view) and
6B (side view) representing a ceramic bridge connection in a strut
can be used. As used herein, a "strut" refers to a segment of a
stent, in a cell segment. FIGS. 6A and 6B illustrate a strut (or
other portion) 405 of a stent, for example a portion of a cell or
of a connector between cells. Ceramic connector bridge 410 is, for
example, one embodiment of ceramic connector bridges 390 shown in
FIG. 5G. The cross-hatched areas of connector bridge 410 represent
the ceramic material through the strut 405. Two holes 415 have been
laser cut. Currently lasercutting capabilities allow holes with
diameters as small as 0.0012 inch, and in the near future should
allow laser cutting of holes with diameters down to at least 0.0008
inch. In other words, these holes are as little as 10-15% of the
average strut width of current stent design.
[0049] Although a process has been described for obtaining a stent
and replacing portions of the stent with electrically
non-conductive bridges to eliminate electrical loops formed by the
stent, stents having the characteristics of the present invention
can be fabricated in other ways. For example, metal/ceramic
connectors 445 similar to the one shown in FIG. 7A can be produced.
These connectors 445 include metal end portions 450 separated by an
electrically non-conductive (ceramic in some examples) material
455. These metal/ceramic connectors 445 can then be welded (or
connected by other methods) to a predesigned stent structure. For
example, for illustrative purposes, FIG. 7B shows portions of two
cells or rings 302 mechanically separated, and then mechanically
connected via one of connectors 445.
[0050] While ceramic non-conductive materials have been used to
describe embodiments thus far, other suitable electrical insulators
can be used. For example, any thermoset or thermoplastic polymers,
like Teflon, PEO, EPTFE, polyurethane epoxies and acrylics, or
other materials can be used, for example, ceramic/polymer
composites or nanocomposites. The materials are to be
non-conductive to such an extent that they reduce Eddy currents
therethrough to a low enough level that it does not result in a
significant disturbance in the MRI-generated image in an area where
MRI visualization is desired. Of interest is the option to combine
different metals in the final stent design and to connect them
using the ceramic connectors or bridges. This allows radiopaque
sections made out of pure gold, platinum or other materials in
those sections of the stent where no mechanical strength is
required, and pure titanium or other strong materials in the
mechanical backbone section of the stent where strength is
required. As described above, in order to eliminate the distortion
in MRI, a non-conductive material must be used in the stent in
order to eliminate electrical loops. Polymers and ceramics are both
materials that fit this criteria. However, polymers can tend to
break down over time in the body, where ceramics are typically
highly biocompatible and will not break down. An analysis of
various ceramic materials, and cements which can be used with the
ceramic materials, is provided at the end of this disclose in
Appendix A.
[0051] Various stent designs are disclosed as solutions to
eliminate the problem of induced current in the stent during MRI.
In addition to those discussed above, four design types or
techniques illustrated in FIGS. 8, 9, 10A-10C and 11A-11C are
provided.
[0052] A first design solution to the problem of the formation of
electrical loops in the stent is to replace a metallic stent
portion with a non-conductive adhesive or cement. This is
represented in FIG. 8 in which the metallic portions 502 of a cell
or a connector are connected together, and separated by, an
electrically non-conductive adhesive, cement or other bonding
material 504. The adhesives and cements discussed in Appendix A are
examples of materials which can be used to form bonding material
504.
[0053] FIG. 9 illustrates a second design alternative which can be
used to eliminate induced currents in stents during MRI. As
illustrated in FIG. 9, this design places a ceramic connector or
bridge 514 (which can be, for example, ceramic connectors 390 or
455 discussed above) in-between sections of the cells and/or
in-between sections of the connectors which connect the cells.
Ceramic bridges 514 can be, for example, cemented or adhered to
metallic sections 512. Ceramic bridges 514 can also be fired onto
sections 512.
[0054] A third type of design, which also includes a ceramic or
other electrically non-conductive material positioned between two
electrically conductive sections of the stent, can be formed using
the process illustrated in FIGS. 10A-10C. Using this technique, as
shown in FIG. 10A, an electrically conductive stent portion 530 is
provided having first and second sections 532 and 534. Stent
sections 532 and 534 are connected by stent sections 536, 538 and
540. Portions of gap 542 extend above the upper surfaces of exist
stent sections 532 and 534 (as viewed in FIG. 10A). Next, as
illustrated in FIG. 10B, the ceramic or other electrically
non-conducting material 544 is formed in gap 542. The ceramic or
other material 544 can be attached to stent sections 532, 534, 536,
538 and 540 using any desired technique. For example, for a ceramic
material, material 544 can be fired on these stent sections. Once
this is completed, laser cutting process can be used to remove
stent sections 536, 538 and 540. The result is a stent structure
546 as shown in FIG. 10C.
[0055] A fourth design or technique is illustrated in FIGS.
11A-11C. As shown in FIG. 11A, using this method an electrically
conductive stent portion 580 is provided. Stent portion 580
includes stent sections 582 and 584 having similar dimensions, and
being in-plane if desired. Formed in-between stent sections 582 and
584 is a narrowed or tapered stent section 586. Stent section 586
narrows from the dimensions of stent sections 582 and 584 down to
dimensions which are smaller than those of sections 582 and 584.
Stent portion 580 can be provided, for example, by obtaining a
stent portion having substantially constant dimensions between
sections 582 and 584, and then laser cutting portions between
sections 582 and 584 to form narrowed stent section 586. Narrowed
stent section 586 is where the conductive path will be "cut-off",
cut out or subsequently insulated in later steps.
[0056] Next, as illustrated in FIG. 11B, a ceramic material 590 is
fired on over narrowed section 586. In the illustrative embodiment,
the ceramic material 590 is formed to have substantially the same
outer dimensions as stent sections 582 and 584, but this need not
be the case in all embodiments. Finally, a laser (or other
techniques) can be used to cut an aperture, hole or tunnel 592
through ceramic material 590. The aperture 592 is aligned such that
the process cuts across narrowed section 586 to eliminate the
conductive path between sections 582 and 584, and thus eliminating
the conductive loop. Aperture 592 can then optionally be refilled
with a ceramic material to obtain a structure similar to the one
shown in FIG. 10C.
[0057] Stents could also be formed from sheets or tubes of metal
stock. Beginning with a sheet or a tube of metal stock, one can
laser cut only the sections to be joined with insulating bridges.
Also indexing notches for future reorientation are cut.
[0058] Holes are abated leaving two or more struts to be joined.
Illustratively, the holes are large enough to expose the struts
while isolating the sides of the holes from contact with ceramic or
polymers. This allows the ceramic portion to contact during
sintering and cooling without stress while allowing a glaze surface
to form, eliminating the need for mechanical polishing.
[0059] Once the tube or sheet has all strut holes cut where ceramic
bridges are to be made, the strut tips are then encased in a drop
of plastic that can be washed away or a bead of wax that can be
boiled away. Then the entire tube or sheet is encased in a thin
layer of plastic that can "burn out" to create resistive film. The
strut tips are then exposed by washing or steaming leaving a
negative mold in the burnout plastic. At this point any surface
treatments (such as media blasting, acid etching, sputter coating,
etc.) can be applied to expose strut tips without damage to the
rest.
[0060] The ceramic can be applied in several ways, among them 1)
dipping, 2) electrophoretic deposition, 3) hot press, and 4) direct
application.
[0061] Using dipping for example, the previously prepared tube or
sheet is dipped into a ceramic slurry (in ultrasonic bath to aid
flow). When withdrawn, the plastic resist allows adherence of
slurry only in strut holes.
[0062] As the liquid portion of the slurry evaporates the deposited
particles condense toward the center, pulling away from the resist
film on the inside of the strut hole, with a resulting ball
encompassing and touching only strut tips. Then, depending on the
ceramic selected it would be sintered or infiltrated. In sinters
the molten ceramic contracts further and high surface tension tends
to pull it into a ball with a smooth surface, (glaze). If
infiltrated as with the inceram alumina or inceram zirconia there
is no sintering shrinkage and infiltration glass forms a glazed
surface.
[0063] Electrophoriec ceramic deposition is somewhat analogous to
electroforming. In this case exposed strut tips act as the anode
and charged ceramic particles collect until a negative mold is
filled. This process is currently being used as an extension of the
in cerem technique.
[0064] In order for these and other designs to function properly,
the non-conductive material must be able to withstand the forces
that the stent undergoes during use. For example, some ceramics are
known to be very strong in compression, but considerably weaker in
tension. FIG. 12 is a plot illustrating tensile stress for one
particular type of strut. This plot illustrates where the high and
low tensile stresses are located when the stent is fully expanded
in one particular example. In this example, a region is located
where there is minimum stress, 10 ksi, throughout the width of the
strut. A non-conductive material could be placed in this minimum
stress area of stent in order to eliminate electrical loops in
adjacent metal portions of the stent. Generally speaking, the
non-conductive material must have an ultimate tensile stress above
the minimum stress for the particular stent in order to avoid
failure.
[0065] A ceramic that is considered biocompatible is either
bioinert or bioactive. A bioinert ceramic provokes minimal response
from the host tissue and there is little physical or chemical
alteration that takes place in the system. These materials tend to
have high wear and corrosion resistance. Alumina, partially
stabilized zirconia and silicon nitride, are all bioinert ceramics.
Currently, typical applications for bioinert ceramics include bone
screws, bone plates, femoral heads and dental restorations. A
bioactive ceramic provides a direct chemical bond with tissue and
bone. They are surface-reactive ceramics with a low solubility.
Hydroxyapatite, calcium phosphate, and bioglasses are all
considered bioactive.
[0066] As mentioned above, Appendix A provides information on
ceramics which have been investigated for potential use in the
production of MRI compatible stents. Included are brief
descriptions of each of the ceramics: aluminia, glass-ceramic,
calcium phosphate, zirconia and silicon nitride. However, the
present invention is not limited to use of the particular ceramics
described in Appendix A. The material can be a ceramic in a
light-curable or catalized material or other materials.
[0067] The metal sections can be made out of any non-ferrous metal
or metal alloys with a magnetic susceptibility smaller then
le-05[cgs/g], such as tantalum, niobium, platinum, gold, titanium,
rhenium, palladium or iridium. The non-metallic section can be made
out of any non-biodegradable polymer such as polyurethanes,
polyethylenes, polyimides, polyamides, polypropylene, polyesters,
etc. The non-metallic section can also be made out of a ceramic or
ceramic\polymer composition. The structural sections of the stent
don't have to be vascular compatible as one can shield the surface
with an additional vascular coating such as for example a ceramic
layer, by means of for example plasma deposition, or by deposition
of a vascular polymer such as for example SIBS
(styrene-isobutylene-Styrene).
[0068] As discussed above, although various embodiments utilize
ceramic materials as the non-conductive connectors or bridges
within the stent to eliminate electrical loops, other
non-conductive materials can be used as well. For example, in
accordance with some embodiments of the invention, after segments
of a continuous metal stent strut geometry are cut away, these
segments are replaced (via injection molding, coating, adhesive
assembly, etc.) with non-conductive elastomers, polymers, or other
non-ceramic insulative materials. As in the previously discussed
embodiments, this will eliminate conductive path loops in the
stent, and thereby reduce the interaction of the stent with the MRI
RF energy.
[0069] FIGS. 13A-13C illustrate embodiments of the invention which
further reduce the occurrence of electrical loops in the stent.
FIG. 13A illustrates a portion 600 of a continuous metal stent
strut which is to be modified by adding a non-conductive connector
or bridge. As shown in FIG. 13B, a segment 605 of the metal stent
strut is cut away, for example using a laser cutting process,
leaving metal end sections 610 and 620. If necessary, the stent can
be mechanically supported during the process of removing section
605 using a variety of techniques, including for example the
technique illustrated in FIGS. 5A-5G.
[0070] Then, as illustrated in FIG. 13C, a non-conductive material
or bridge 622 is formed between metallic end sections 610 and 620.
Non-conductive material 622 can be, for example, elastomer
material, polymer material, ceramic material, or other insulative
materials, and can be formed using a variety of techniques such as
those described above. As discussed previously, this reduces
conductive path loops in the stent to thereby reduce the
interaction of the stent with the MRI RF energy.
[0071] However, if the insulative segments 622 are found to be
electrically bridged by conductive paths between the stent metal
end sections 610 and 620 and body tissue or fluids, further
enhancements can be made to the stent. For example, as illustrated
in FIG. 13C, the metal stent 600 is coated with a biocompatible,
insulative covering or coating 625. Examples of materials that can
be used for the insulative segments 622 and coating 625 are
polyethylene oxide (PEO), Polyetheretherketone (PEEK) or other
appropriate oxide layer.
[0072] As described in previous embodiments, one way to reduce or
eliminate the artifacts in MRI by non-ferrous metal stents is to
make hybrid (metal-ceramic) structures avoiding any electrical
closed loops. As was proposed, the production process can start by
taking a finished metal stent, laser cutting slots in the stent to
disconnect the struts. By filing these slots with a ceramic, one
can re-establish the stent structure. While the previously
described technique can be effective, other less labor intensive
techniques of producing stents, without electrical loops, are also
disclosed.
[0073] To build further upon the earlier disclosed idea of
producing a MRI compatible stent out of nonferrous metals and
ceramics, the idea is to start with making all the loose metal
components out of flat metal pieces by a stamping or cutting or
metal injection molding process. In other words, instead of
dividing a stent in a number of separate elements as was the result
of making slots in a finished stent, the idea is to make these
separate elements directly out of base material. The parts can
subsequently be bent to the required stent radius. However the
bending and cutting of the parts can actually also be done in a
combined processing step by forcing the metal plate in a preshaped
curved die. A very suitable process for this stamping/bending
operation would be to use a magnetic pulse system. these systems
are known and magnetic pulse system is described for example at
website http://www.pulsar.co.il/technology/advantages.htm. The
advantage of using a magnetic pulse system being high precision (1
micrometer) and high repeatability of the process, as well as this
being a cold process. Of course, conventional stamping would also
be applicable. Another process which can be used to form these
parts out of flat plates is photo etching.
[0074] Using (UV-curing) adhesives, in combination with micro
assembly technologies of the type used in microelectromechanical
systems (MEMS) fabrication, stents can be constructed out of these
stent-kits. For example the precision micro assembling kit made by
Sandia laboratories
(http://www.sandia.gov/isrc/Capabilities/Prototyping/Precision_Miscro_Ass-
embly/precision_micro_assembly.html) can be used.
[0075] Further, ceramic or polymer inlets can be added in addition
to just gluing the elements together. This allows the creation of
electric capacitors in the stent design. In case of using doped
polymers (carbon fibers or other fillers), conducting polymers, or
conducting ceramics, resistors can be created in addition to
capacitors. Polyaniline or polyAcetylene polypyrolle doped with 12
are examples of conducting polymers. Table 1 shown below shows the
conductance of some potential ceramics, but of course there are
many more available.
TABLE-US-00001 TABLE 1 Thermal conductivity Electrical conductivity
[W m - 1 K - 1] [W cm] Al203 20 1012 BN 33 2 1013 MoSi2 50 21.6 10
- 6 SiC 90 ~2 Si3N4 15-20 1013 TiC 10 65-85 10 - 6 TiN 20 0.11 10 -
4 Y2O3 18 >108 ZrB2 60 9.7 10 - 6 107-108 at 20.degree. C.
[0076] The combination of capacitors, resistors and the inherit
presence of a coil structure (the stent structure) would allow the
creation of LRC circuits in the stent with resonant frequencies
equal to the Larmor frequency. The addition of the resistors would
allow designs to influence the quality factor Q of the circuit, and
by that the width of the resonant peak, in order to compensate for
a frequency mismatch between the resonant frequency and the Larmor
frequency. This mismatch is highly likely to occur as the
self-inductance of the stent coil geometry is independent of the
geometry of the stent after deployment. Therefore, it may be better
to work with lower Q-factors in order to more easily compensate for
any mismatch.
Q=1/(.omega..sub.0.C.R)
[0077] In embodiments in which LRC circuits are to be created in
the stent, when using adhesives to connect the ceramic or polymer
inlets to the metal stent structure, electrically conducting
adhesives can be used, or care can be taken to make sure that part
of the metal structure is in direct contact with the inlet or
electrical contact is made after the inlet is glued.
[0078] Finally in relation to the electric circuits, in order to
provide an outside electrical isolating layer, the entire stent is
coated with a polymer or ceramic non-conducting coating. Plasma ion
immersion implantation (PIII) processes can be used in obtaining
coverage of the stent with the isolating ceramic layer. Plasma
deposition can create the isolating layer. An electric isolating
layer prevents conductance through the surrounding blood and tissue
which could short-circuit the ceramic/polymer inlets.
[0079] Since parts of many shapes can be made out of most metals
and alloy, stents can be made out of multiple metals, for example
highly radiopaque metals like Platinum or Gold near a distal or
proximal edge, and very flexible alloys like Nitinol or strong
alloys like Titanium at structurally essential locations. The
separation of the metal elements by ceramics, as well as the
complete enclosure of the whole stent by a ceramic layer or other
layer, will prevent corrosion caused by galvanic reactions between
the different metals. In other words, hybrid ceramic-metal stents
with coatings allow the use of any number of metals which might not
ordinarily be used together.
[0080] Using stent-kits as described allows any shape of stent to
be built. Besides building the usual round stents, non-circular,
tapered, side-branched or multi-layer stents can be fabricated. For
example one could build a bifurcation stent using a stent-kit. This
technology could also be used to make septal defect closure
devices.
[0081] FIG. 14 is a diagrammatic side view illustration of a
portion of a stent 650 in accordance with yet another embodiment of
the present invention. While various embodiments of the present
invention have been shown which include ceramic or other
non-conducting materials used to electrically isolate first and
second metallic end sections of the stent, while at the same time
structurally supporting the stent to some degree, layered
metal/ceramic structures can be used as well. Layered structures
of, for example, metal/ceramic/metal are known, as are methods of
manufacturing such layered structures. Such a layered structure
will not reduce the occurrence of RF artifacts during MRI if the
metal layers of the structure are allowed to form closed loops.
However, if discontinuities are formed in the metal layers, but not
in the ceramic layer, this process can be used to eliminate
electrical loops, and thereby the occurrence of RF artifacts.
[0082] As shown in FIG. 14, stent portion 650 is formed from a
layered structure which includes metal layers 654 and 656 on either
side of ceramic layer 652. Fine slits 653 and 655 are made,
respectively, in outer metal layers 654 and 656 in order to
eliminate electrical loops formed by either of these layers.
Although for illustrative purposes slits 653 and 655 are shown in
close proximity to each other, this need not be the case. To
maximize the strength of the strut, slits 653 and 655 can be made
in different portions of the stent (for example in different
portions of a particular cell or connector) or in other
non-overlapping configurations such that at any specific location
the stent includes at least the ceramic layer and one of metal
layers 654 and 656. Slits 653 and 655 can be made, for example,
using a UV-ablation laser or an ultrashort pulsed laser. If the
entire surface of the stent (or at least the regions surrounding
any slit) is coated with an isolating oxide layer 658, then there
is little or no risk of current bridging across the slits using
surrounding blood or tissue.
[0083] Shown in FIG. 15 is a portion of a stent 675 which
demonstrates various concepts of the present invention described
above. For example, as described above with reference to the graph
shown in FIG. 12, stent 675 can be made using high strength metals
in one or more regions 677 determined to be high stress regions of
the stent, while electrically non-conductive materials can be used
in one or more regions 679 determined to be low stress regions in
order to eliminate electrical loops while maintaining sufficient
structural strength of the stent. In the alternative, low magnetic
susceptibility material, such as Titanium, can be placed in the low
stress regions 679, while higher magnetic susceptibility materials
such as Tantalum can be placed in regions 677 where more strength
is required. In this manner, total magnetic susceptibility of the
stent can be reduced without negatively impacting its mechanical
performance.
[0084] Consistent with the above discussions, current stainless
steel and nitinol stents have been found to be less than ideally
compatible with MRI and MRA imaging, because the magnetic
susceptibility of the metal alloys is sufficiently high relative to
human tissues and creates a disturbance in the magnetic field of
the scanner, and because the continuous metal loops in the stent
geometry have induced currents leading to RF shielding. As a
result, the area within the stent lumen and area adjacent to the
stent often have signal void that prevents diagnostic or procedural
imaging there.
[0085] In this disclosure approaches to building a passive MRI
compatible stent have been described. These approaches can be
summarized as using a stent metal material with significantly low
magnetic susceptibility, and designing a structure that does not
have closed conductive loops. The challenge is that structures
without interconnections are not as strong and stiff as structures
with connections. This approach could lead to stents with
compromised mechanical properties and scaffolding in order to gain
MRI compatibility.
[0086] A disclosed technique for making such a stent is to create
metal discontinuities by laser or mechanical cutting, and to attach
the ends of the discontinuities with insulative fasteners.
Generally, a stent 690 of this type is shown in FIG. 16 with
ceramic bridges (or other electrical discontinuities) 692 formed in
each cell 694 and in each connector 696. The stent is shown engaged
in a lumen 691. Beyond use of pure ceramics and pure polymers,
re-enforcement layers can be used as well.
[0087] Although the present invention has been described with
reference to illustrative embodiments, workers skilled in the art
will recognize that changes may be made in form and detail without
departing from the spirit and scope of the invention.
APPENDIX A
[0088] The focus of this project is to develop a MRI compatible
stent. Currently, stents are not compatible because they cause an
artifact (distortion) in the image. Blood flow through the stent
along with the tissue surrounding the stent can not be seen as a
result of these artifacts. There are two main factors associated
with the stents that cause artifacts in the MRI: the magnetic
susceptibility of the implant material and the interference caused
by the Faraday effect. MRI functions by assuming a uniform magnetic
field, so when there are materials present with high differences in
magnetic susceptibilities the image becomes distorted. In order to
reduce these factors, materials with low magnetic susceptibilities
(as close to water and human tissue as possible) must be used. The
second reason for distortion can be explained with Faraday's Law.
When a coil of wire (in this case a stent) is placed in a changing
magnetic field a current is induced. This current interferes with
the field from the magnet and results in a distortion. Eliminating
these conductive path loops in the stent will reduce the
interference with the MRI. One way of accomplishing this is to use
a nonconductive material in portions of the stent to "cut-off" any
conductive paths. Ceramics have been the focus due to their high
biocompatibility. The ceramic would have to be bond on to the stent
with an adhesive, fired-on or some other technique.
[0089] This report contains a brief description of the different
designs that are currently being considered to eliminate the
artifacts. The stress tests that have been conducted on a stent are
discussed. Research was conducted on the different ceramics and
cements that could be used Data that was obtained from different
suppliers is included in this report. The tests that have been
conducted and are being conducted to test the bonding strength of
different cements are also discussed.
TABLE-US-00002 PROPERTIES OF CERAMICS Modulus Flexural Compressive
Ultimate of Strength, Yield Tensile Fracture Density, Elasticity,
MPa Strength, Strength, Toughness, Material g/cc GPa (psi*10.sup.6)
(ksi) MPa (ksi) MPa (ksi) MPa-m.sup.1/2 80-85% Alumina 3.45-3.5
215-240 205-310 965-2760 103-138 (31.2-34.8) (29.7-45) (140-400)
(15-20) 90-95.5% Alumina 3.55-3.96 300 (43.5) 276-345 2068-2586
138-193 3.5-4.5 (40-50) (300-375) (20-28) 96-98% Alumina 3.67-3.96
300-355 296-375 2068-2586 131-205 3.5-5.0 (43.5-51.5) (42-54)
(300-375) (19-29.7) 99-99.5% Alumina 3.83-3.89 375 (54.4) 310-379
2550-2600 172 (25) 4-4.5 (45-55) (370-377) >99.5% Alumina
3.75-3.97 375-393 345-482 2068-3650 138-220 4-5 (54.4-57) (50-70)
(300-530) (20-32) Alumina, ZTA 4.0 360 (52.2) 450 (65.3) 2900 (421)
5-6 Zirconium oxide 210 (30.5) 1000 (145) 2000 (290) 7 (1.02) 10
99.9% (Zr/Hf/Y) Glass Ceramic 2.52 66.9 (9.7) 94 (13.6) 345 (50)
1.53 Zirconia, TTZ 5.7 200 (29) 620 (89.9) 1750 (254) 11 Zirconia,
FSZ 6.0 200 (29) 900 (131) 2500 (363) 13 Zirconia, PSZMg 5.7 200
(29) 620 (89.9) 11 Zirconia, PSZYt 6.0 200 (29) 850 (123) 8 Silicon
nitride, 96-220 520 (75.4) 68-172 Reaction sintered (13.9-31.9)
(9.86-24.9) Silicon nitride, 3.31 317 (46) 679-896 689-2760 360-434
5.0-8.0 hot pressed (98.5-130) (99.9-400) (52.2-62.9) ZTA--Zirconia
Toughened Alumina TTZ--Transformation Toughened Zirconia FSZ--Fully
Stabilized Zirconia PSZMg--Partially Stabilized Zirconia with
Magnesium PSZYt--Partially Stabilized Zirconia with Yttrium
TABLE-US-00003 MELTING TEMPERATURES OF CERAMICS AND METALS Material
Melting Temp, .degree. C. (.degree. F.) Alumina 2050 (3722)
Zirconia 2681-2847 (4857.8-5156.6) Silicon Nitride 1926 (2200)
Titanium 1668 Tantalum 2200-2996
Aluminum Oxides
[0090] The most common form of aluminum oxides used is
polycrystalline .alpha.-Al.sub.2O.sub.3. As the grain size of these
decreases the strength increases. Alumina products can be purchased
with purities anywhere from 80-99.90%. Typically, as the purity
increases so does the strength. Alumina with a content greater than
99.5% has excellent corrosion and wear resistance. However, the
more pure the alumina the more expensive the product is as well.
The alumina can also be strengthened by adding zirconia (Zirconia
Toughened Alumina, ZTA). Alumina devices used in the medical field
are produced from high purity alumina that is sintered and pressed
at temperatures between 1600-1700.degree. C. This material is
commonly used in joint replacement because of its hardness and
excellent wear resistance. It can also be used in dental
restorations. Problems with this material include its brittle
nature along with difficulty in fabrication. There are some alumina
products that are specifically designed to be easily machined. One
way to increase the machinability is to produce porous alumina;
however, these products-usually sacrifice strength for
machinability.
Suppliers
[0091] Associated Ceramics and Technology, Inc. has alumina
available ranging from 80-99.9%. The following table indicates the
different properties of these products. The company can machine the
products into different shapes upon request.
TABLE-US-00004 TABLE 1 ASSOCIATED CERAMICS AND TECHNOLOGY, INC.
ALUMINA PRODUCTS PROPERTIES Alumina Flexural Compressive Tensile
Content, Density, Strength, Strength, Strength, Product % g/cc MPa
(ksi) MPa (ksi) MPa (ksi) ACT 80-85 3.45-3.5 241-276 1793 103-138
800-850 (35-40) (260) (14.9-20) ACT 90-96 3.55-3.75 276-345
>2068 138-193 900, 920, 960 (40-50) (>300) (20-28) ACT
>99.5 3.75-3.96 345-379 >2068 138-172 990, 997, 999 (50-55)
(>300) (20-24.9)
[0092] MarkeTech International Inc. also has a selection of alumina
products available. The typical properties for their products are
shown below.
TABLE-US-00005 TABLE 2 MARKETECH INC. ALUMINA PRODUCTS PROPERTIES
Alumina Elastic Flexural Tensile Fracture Content, Density,
Modulus, Strength, Strength, Toughness, Product % g/cc GPa
(psi*10.sup.6) MPa (ksi) MPa (ksi) (MPa-m.sup.1/2) 960P 96.0 3.67
300 (43.5) 375 (54.4) 205 (29.7) 4-5 975P 97.5 3.75 355 (51.5) 375
(54.4) 205 (29.7) 4-5 995P 99.7 3.96 375 (54.4) 410 (59.5) 220
(31.9) 4-5 ZTA 80.0 4.1 340 (49.3) 450 (65.3) -- 7
Astro Met Inc. produces several forms of alumina. This company
manufactures 2 different aluminum oxides: AmAlOx 68 and AmAlOx 87.
AmAlOx 68 is 99.8% aluminum oxide and has been developed for
maximum wear and corrosion resistance. This material has a high
density; high hardness, fine grain structure, and excellent
mechanical strength. AmAlOx 87 has a higher purity for
applications, which require a pure material along with a high
density, high strength, and small grain size. The small grain size
allows for tight tolerances. This product was originally developed
for critical load bearing medical implants. ZTA-96 is a
zirconia-toughened alumina, composed of 85% alumina and 15%
zirconia. This product combines wear resistance property from
AmAlOx 68 with high strength and toughness of AmZirOx 86.
Properties for all of these products are shown in Table 3.
TABLE-US-00006 TABLE 3 ASTRO MET, INC. ALUMINA PRODUCTS PROPERTIES
Grain Modulus of Flexural Fracture Density, Size, Elasticity,
Strength, Toughness, Product g/cc .mu.m GPa (psi*10.sup.6) MPa
(ksi) MPa-m.sup.1/2 AMALOX 68 3.93 4 393 (57) 382 (55.4) 5 99.8%
Alumina AMALOX 87 3.97 2 -- 482 (69.9) -- 99.95% Alumina ZTA-96 4.1
1.5 310 (45) 760 (110) 6 85% Alumina 15% Zirconia
[0093] Superior Technical Ceramics Corp. supplies 5 different dense
alumina products ranging from 95-99.8%. The following table lists
the properties of these products. The company produces different
sizes in both plate and rod form.
TABLE-US-00007 TABLE 4 SUPERIOR TECHNICAL CERAMICS CORP. ALUMINA
PRODUCTS PROPERTIES Flexural Compressive Tensile Alumina Strength,
Strength, Strength, Content, % MPa (ksi) MPa (ksi) MPa (ksi) 95 283
(41) 2206 (320) 138 (20) 96 310 (45) 2068 (300) 131 (19) 98 296
(43) 2413 (350) 152 (22) 99.5 310 (45) 2586 (375) 173 (25) 99.8 310
(45) 2586 (375) 172 (25)
[0094] Cotronics focuses on machinable ceramics. The company
produces an aluminum silicate (Rescor 902) and a 96% alumina
(Rescor 960) which can both be machined with standard shop
equipment. All of Cotronics' products can be purchased in rods or
plates. The properties of these two products are shown in Table
5.
TABLE-US-00008 TABLE 5 COTRONICS ALUMINA AND ALUMINA SILICATE
PROPERTIES Flexural Compressive Density, Strength, Strength,
Product g/cc MPa (ksi) MPa (ksi) Rescor 902 - 1.92 96.5 (14) 262
(38) Aluminum Silicate Rescor 960 - 3.8 262 (38) 414 (60) 96%
Alumina
[0095] Accuratus Ceramic Corp. produces three grades of alumina
(94, 96, 99.5%) all in the alpha phase. The company can fabricate
the ceramic to a specific design need. Table 6 shows the properties
for these ceramics.
TABLE-US-00009 TABLE 6 ACCURATUS CERAMIC CORP ALUMINA PRODUCTS
PROPERTIES Alumina Modulus of Shear Flexural Compressive Fracture
Content, Density, Elasticity, Modulus, Strength, Strength,
Toughness, % g/cc GPa (psi*10.sup.6) GPa (psi*10.sup.6) MPa (ksi)
MPa (ksi) MPa-in.sup.1/2 94 3.69 300 (43.5) 124 (18) 330 (47.9)
2100 (305) 3.5 96 3.72 300 (43.5) 124 (18) 345 (50) 2100 (305) 3.5
99.5 3.89 375 (54.4) 152 (22) 379 (55) 2600 (377) 4
[0096] International Ceramic Engineering (ICE) manufactures and
fabricates different ceramics, including four different alumina
materials (94, 96, 99.5, 99.8%). The company specializes in
post-fire machining and tight tolerance grinding. All different
shapes can be fabricated including custom designed ones. A zirconia
toughened alumina is also available. The properties for ICE's
alumina products are shown in Table 7.
TABLE-US-00010 TABLE 7 INTERNATIONAL CERAMIC ENGINEERING ALUMINA
PRODUCTS PROPERTIES Alumina Flexural Compressive Tensile Fracture
Content, Density, Strength, Strength, Strength, Toughness, % g/cc
MPa (ksi) MPa (ksi) MPa (ksi) MPa-m.sup.1/2 94 3.96 310 (45) 2586
(375) 172 (25) 4.5 96 3.96 310 (45) 2586 (375) 172 (25) 4.5 99.5
3.85 310 (45) 2586 (375) 172 (25) 4.5 99.8 3.92 296 (43) 2413 (350)
152 (22) 4.5 ZTA -- 450 (65.3) 2900 (421) -- 5-6
Glass-Ceramics
[0097] Glass-ceramics typically have high tensile strength and high
resistance to abrasion. However, the downfall with this type of
material is that it is very brittle and can not be used in a
load-bearing operation. This polycrystalline material is formed by
controlling the crystallization of glasses. The grain size of
glass-ceramic is smaller than conventional ceramics. The tensile
strength is typically between 100-200 MPa (14.5-29 ksi). It has a
resistance to abrasion and scratching similar to sapphire. The
fatigue behavior may be better than that of conventional
ceramics.
Suppliers
[0098] Corning produces Macor, which is a machinable glass-ceramic
with good physical properties, no porosity, and is electrically
insulating. Macor is composed of 55% fluorophlogopite mica and 45%
borosilicate glass (weight percent of compounds shown below). The
randomly ordered mica flakes allows the material to be machined.
This product can be joined to other materials in a variety of ways.
Brazing has been used to join Macor to different kinds of metals,
an epoxy can be used, sealing glass produces a tight seal and a
mechanical joint can be made. The material can be machined using
diamond, silicon carbide or aluminum oxide grinding wheels. The
properties of Macor are shown below.
TABLE-US-00011 TABLE 8 MACOR MACHINABLE GLASS CERAMIC COMPOSITION
Silicon Magnesium Aluminum Potassium Boron Fluorine SiO.sub.2 MgO
Al.sub.2O.sub.3 K B.sub.2O.sub.3 F Composition, 46 17 16 10 7 4 wt
%
TABLE-US-00012 TABLE 9 MACOR MACHINABLE GLASS CERAMIC PROPERTIES
Modulus of Shear Flexural Compressive Fracture Density, Elasticity,
Modulus, Strength, Strength, Toughness, g/cc GPa (psi*10.sup.6) GPa
(psi*10.sup.6) MPa (ksi) MPa (ksi) MPa-m.sup.1/2 Macor 2.52 66.9
(9.7) 25.5 (3.7) 94 (13.6) 345 (50) 1.53
[0099] Cotronics, Astro Met Inc., Accuratus and International
Ceramic Engineering all supply Macor. The product can be purchased
in rods or plates. Both Accuratus and ICE will custom design the
glass-ceramic to fit the customers needs.
[0100] Bioglass (USBiomaterials, Alachua, Fla.) and Ceravital (E.
Leitz Wetzlar GmBh; Wetzlar, Germany) are bioactive glasses that
have been successful in clinical tests. The following two tables
list the composition and the mechanical properties of these two
bioactive glasses.
TABLE-US-00013 TABLE 10 BIOGLASS AND CERAVITAL COMPOSTIONS
Composition, wt % SiO.sub.2 NaO CaO P.sub.2O.sub.5 MgO K.sub.2O
Bioglass 45 24.5 24.5 6.0 -- -- Ceravital 40-50 5-10 30-35 10-15
2.5-5.0 0.5-3.0
TABLE-US-00014 TABLE 11 BIOGLASS AND CERAVITAL PROPERTIES Elastic
Modulus, Compressive Strength, Properties GPa (psi*10.sup.6) MPa
(ksi) Bioglass 35 (5.08) 42 (6.09) Ceravital 100-150 (14.5-21.8)
500 (72.5)
Further information on suppliers of these two products was not
found.
Zirconia
[0101] The crystal structure of zirconia at room temperature is
monoclinic, which has excellent dielectric, piezoelectric, and
ion-conductive properties. By adding dopants this structure can be
stabilized and transformed into the tetragonal crystal structure
(Partially Stabilized Zirconia--PSZ). Zirconia has a high chemical
resistance, a high fracture toughness (K.sub.IC), high bending
strength, and a high hardness. Unlike other ceramics, a crystal
transformation (tetragonal to monoclinic) and volume expansion
(3-5%) can take place at the appearance of a high-tension region.
The volume expansion causes wedges in the cracks thus slowing down
the continuation of the crack. The elastic modulus for all forms of
zirconia range from 190-230 GPa (27.6*10.sup.6-33.4*10.sup.6 psi).
The flexural strength and fracture toughness varies with the form
and the grain size. The material is usually formed by adding a
dopant and then the composition is hot pressed. The melting
temperature of zirconia ranges from 2681-2847.degree. C.
(4857.8-5156.6.degree. F.), which is too high for this ceramic to
be fired onto a metal. Current typical applications for zirconia
are for femoral heads, artificial knees, bone screws and plates and
dental restorations.sup.2. Zirconia has excellent wear resistance
and higher fracture toughness and stiffness than alumina. It is
commonly only used when alumina does not have high enough strength
due to the high cost.
Suppliers
[0102] Astro Met Inc. produces AmZirOx 86, a yttria stabilized
zirconia (Yttria Tetragonal Zirconia Polycrystal, Y-TZP). The
product's high strength and toughness allow this material to
function well in applications where wear, corrosion, impact and
abrasion are factors. The product undergoes transformation
toughening which allows for it to withstand impact forces that most
ceramics can not. Table 12 gives the properties of this zirconia
product.
TABLE-US-00015 TABLE 12 ASTRO MET, INC. ZIRCONIA PROPERTIES Grain
Modulus of Flexural Fracture Density, Size, Elasticity, Strength,
Toughness, Product g/cc .mu.m GPa (psi*10.sup.6) MPa (ksi)
MPa-m.sup.1/2 AmZirOx 86 6.01 0.5 204 (29.6) 1000 (145) 7 95%
Zirconia 5% Yttria
[0103] Vesuvius McDanel produces a yttria stabilized zirconia
ceramic (Z105) with a composition as shown below.
TABLE-US-00016 TABLE 13 VESUVIUS MCDANEL ZIRCONIA CERAMIC
COMPOSITION Compound wt % Zirconia (ZrO.sub.2) 88.84 Yttria
(Y.sub.2O.sub.3) 10.5 Silica (SiO.sub.2) 0.2 Alumina
(Al.sub.2O.sub.3) 0.17 Titania (TiO.sub.2) 0.14 CALCIA (CAO) 0.1
MAGNESIA (MGO) 0.01 Sodium Oxide (Na.sub.2O) 0.006 Potassium Oxide
(K.sub.2O) 0.002
This product has the following properties:
TABLE-US-00017 TABLE 14 VESUVIUS MCDANEL ZIRCONIA PROPERTIES
Flexural Compressive Density, Strength, Strength, Product g/cc MPa
(ksi) MPa (ksi) Zirconia 5.72 276 (40) >1772 (257) (Z105)
[0104] International Ceramic Engineering has two forms of zirconia
available for purchase: transformation-toughened zirconia (TTZ) and
yttria-stabilized zirconia polycrystals (YTZP). The properties for
these zirconia products are shown in Table 15.
TABLE-US-00018 TABLE 15 INTERNATIONAL CERAMIC ENGINEERING ZIRCONIA
PROPERTIES Modulus of Flexural Compressive Fracture Zirconia
Elasticity, Strength, Strength, Toughness, Form GPa (psi*10.sup.6)
MPa (ksi) MPa (ksi) Mpa-m.sup.1/2 TTZ 200 (29) 620 (89.9) 1750
(254) 11 YTZP 200 (29) 900 (130.5) 2500 (363) 13
Calcium Phosphate
[0105] Calcium phosphate based ceramics are commonly researched as
a possible material for hip replacements and dental implants due to
the capability of the ceramic to sustain bone cell growth.
Hydroxylapatite (HA), Ca.sub.10(PO.sub.4).sub.6(OH).sub.2,
resembles the primary inorganic component of bone, and is currently
used to coat metal joint implants for better cementation. Typical
calcium phosphate polycrystalline hydroxyapatite values are as
follows: elastic modulus=40-117 GPa (5.8*10.sup.6-17*10.sup.6 psi),
flexural strength=147 MPa (21.3 ksi) and density=3.16 g/cc. Dense
calcium phosphate has tensile strengths ranging from 40-200 MPa
(5.8-29 ksi) and compressive strengths of 120-900 MPa (17.4-130.5
ksi).sub.5.
Suppliers
[0106] Spire Corporation produces SPI-Ceramic.TM., which is a film
that can be applied to ceramics, metals, or polymers. This ceramic
film is used in the medical area to improve the mechanical and
biological properties of the devices. Applications for this product
include: orthodontic appliances, dental implants, blood collection
and monitoring devices, needles and needle guidewires, orthodontic
implants, and spinal screws. This film is beneficial because it
improves the blood compatibility and is corrosion resistive.
Mechanically, it improves the wear resistance and hardness of the
devices.
Silicon Nitride
[0107] This particular material is known for its high strength,
hardness and fracture toughness. Silicon nitride compounds can
withstand high structural loads (even at high temperatures) and it
has excellent wear resistance.
Suppliers
[0108] Rauschert Industries Inc. produces several different
varieties of ceramics including silicon nitride. Properties for
this material are shown below.
TABLE-US-00019 TABLE 16 RAUSCHERT INDUSTRIES INC SILICON NITRIDE
PROPERTIES Modulus of Flexural Compressive Fracture Density,
Elasticity Strength, Strength, Toughness, g/cc GPa, (psi*10.sup.6)
MPa (ksi) MPa (ksi) MPa-m.sup.1/2 Silicon 3.23 290 (42) 800 (116)
>2500 (363) 7 Nitride
[0109] International Ceramic Engineering produces a silicon nitride
that is lightweight and has good thermal characteristics. The
properties of this silicon nitride product are shown in the
following table.
TABLE-US-00020 TABLE 17 INTERNATIONAL CERAMIC ENGINEERING SILICON
NITRIDE PROPERTIES Flexural Fracture Density, Strength, Toughness,
g/cc MPa (ksi) Mpa-m.sup.1/2 Silicon 2.50 345 (50) 3.0 Nitride
Feldspathic Porcelain
[0110] In dentistry, leucite reinforced feldspathic porcelain is
commonly used. This ceramic typically contains about 60% SiO.sub.2,
20% Al.sub.2O.sub.3, and various amounts of Na.sub.2O and K.sub.2O
for expansion control. Porcelain can be slurry formed or hot
pressed and has flexural strengths ranging from 60-165 MPa. The
formation of leucite crystals strengthens the material by
inhibiting micro crack propagation. These crystals also control the
thermal expansion. Porcelain can be strengthened through fusion to
a higher CTE, which leads to residual compressive stress that
limits crack formation. In order to counter Griffith's flaws,
compression can be induced on the surface through ion exchange of
potassium atoms for sodium atoms. Manufacturers claim that this
process increases the tensile strength by 53%. Tuf Coat GC
International, Tokyo, Japan and university tests confirm these
results. Duceram low fusing ceramic from Degussa, Germany was the
lowest temperature material at 640.6.degree. C. (1185.degree. F.)
that was found.
Materials and Methods
[0111] The first step in producing porcelain fused to metal crown
is to take an impression from the mouth to make an analog of the
tooth from artificial stone. Next, a thin layer of metal in the
shape of a thimble is made to adapt intimately to the
cut-tooth-structure. The metal is usually formed through the lost
wax casting method, but cad-cam, electroforming, and foil and
sintered metal can also be used. The purpose of this is to produce
a 300 micron or thinner substructure (coping) which the layers of
shaded porcelain can be stacked. Gold, platinum, palladium, silver,
nickel, chrome, cobalt and titanium are all metals that can be used
for the substructures. Trace elements are added to these for grain
refinement and oxide formation. The formation of metal oxides into
a molten ceramic opaque layer creates a strong covalent bond
between the metal and ceramic. For materials, such as gold, that
are non-oxidizing a bonding agent (powdered metal and ceramic frit)
is used. To mask the metal and develop color, a layer of opaque
porcelain is fired on the surface. In small increments the
powder/liquid slurry is used to build up the anatomic shape (plus
the shrinkage of the material) of the tooth. The powder is allowed
to dry in a vacuum chamber and then heated at 100.degree. F. per
minute from 950.degree. F. to 1680.degree. F. The shape is
corrected and the surface textured refined. The crown is fired in
air to form a surface glaze.
[0112] Titanium is an attractive choice for a substructure because
of its biocompatibility and low cost. Porcelain systems have been
developed with lower firing temperatures in order to avoid
structural damage to the titanium. These systems have lower thermal
expansions to match the CTE of titanium. To avoid oxidation at the
metal ceramic interface methods such as, argon purge, bonding
paste, electroplating and sputter coating are used. A test was
devised to determine whether these techniques could be applied to
produce an electrically insulating, biocompatible, strong bond to
metal. Details about these tests can be seen in the test
section.
Other Ceramics
[0113] Stronger ceramics have been developed to improve the optical
properties and eliminate the need for metal reinforcement. John
McClean added alumina crystals to porcelain (aluminous porcelain)
to blunt microcracks. This material was stronger, but too amie for
dental applications. Dentsply marketed Corning's Macor under the
name Dicor. Although test data looked promising, survival in the
mouth proved poor and the product was removed from the market.
Empress (Ivoclar, N.A Amherst, N.Y.) is a hot pressed Leucite
reinforced feldspathic porcelain. Empress II is a
lithium-disilicate glass framework that is layered with
flourapatite based veneering porcelain. This material has a
flexural strength of 350 MPa. Inceram alumina from Vita Zahnfabrik
in Bad Sakingen, Germany is a mesh of lightly sintered alumina that
has been infiltrated with glass and veneered with porcelain. Three
point bending tests indicated a flexural strength of 446 MPa.
Inceram zirconia (Vita Zahnfabrik) is similar to Inceram alumina
only with 35% partially stabilized zirconia, which increases the
flexural strength to 800 MPa. Procera from Noble Biocare (Gotborg,
Sweden) is a densely sintered high purity aluminum oxide with
veneered framework and feldspathic porcelain. The flexural strength
of Procera is 600 MPa. Cercon, a yttria-stabilized tetragonal
zirconia from Dentsply Ceramco (York, Pa.) has a flexural strength
of 900 MPa. Partially sintered blocks are milled and fully sintered
at high temperatures [5000.degree. F. (2760.degree. C.)] for
several hours. The fired samples shrink 20-30%.
CONCLUSION
[0114] While all the ceramics listed are biocompatible and all have
the potential to withstand the required forces, an alumina or
zirconia product would most likely be the best ceramic for a
ceramic to adhere to metal. Alumina and zirconia have high
strengths along with high corrosion and wear resistance. Zirconia
is stronger than alumina and at smaller sizes the machinability is
better. However, due to the high cost of zirconia, alumina should
be chosen if it functions appropriately for this application.
Another option is the zirconia toughened alumina which adds
strength to the alumina, yet is not as expensive as zirconia. If
the ceramic is going to be fired on the stent as opposed to
cemented then the melting temperature of the ceramic compared to
the metal used will be crucial. The ceramic must melt at a low
enough temperature to not effect the structure of the metal.
Silicon nitride has a considerably low melting temperature for a
ceramic; however, this material does not have as high of strength
as zirconia or alumina.
Cements
[0115] This section lists some of the common cements that are
currently being used in the medical field. These cements are used
for both ceramic and metallic bonding. This report focuses on the
cements that are being used in the dentistry area, because it is an
area where biocompatible cements are commonly used. It was assumed
that if the cement has been deemed orally biocompatible it is
likely that it will function throughout the rest of the body,
although further testing would have to be done to assure this
assumption.
[0116] This report gives a brief description of each of the
cements; zinc phosphate, glass ionomer, resin reinforced glass
ionomer, polycarboxylate, cyanoacrylates, and resin composites.
After each of the descriptions there are some suppliers listed and
a more detailed description of their particular product. References
to the web sites where this information and further information can
be obtained are given in the footnotes.
TABLE-US-00021 TABLE 1 CEMENT PROPERTIES Diametric Tensile Ultimate
Compressive Elastic Modulus Cement Supplier Product Strength MPa
(ksi) Strength MPa (ksi) GPa (ksi) Zinc Phosphate (general data)
(general data) 5-7 (0.725-1.015) 80-110 (11.6-15.95) 13 (1885)
Ormco Zinc Phosphate 5.52 (0.800) 75.8 (11.0) Ormco Protech Gold
11.7 (1.697) 96.5 (14.0) Glass Ionomer (general data) (general
data) 90-230 (13.05-33.36) Pulpdent GlassCore 179 (25.96) Pulpdent
GlassBase 227 (32.92) 3M Ketac-Cem 141 .+-. 14 (20.45 .+-. 2) 3M
Ketac-Molar 230 (33.36) 3M Vitremer Luting 23.2 (3.365) 132.5
(19.2) RRGI 3M Vitrebond Bisco Illusion 45 (6.527) 300 (43.51) 6
(870) Bisco C&B 43 (6.237) 235 (34.08) 7.2 (1044) Resin 3M
RelyX ARC 65 (9.427) 340 (49.31) [LC] [LC] 60 (8.702) 325 (47.13)
[SC] [SC] J. Morita Bistite II DC 42 (6.091) 348 (50.47) J. Morita
M-Bond N/A N/A RRGI--Resin Reinforced Glass Ionomer LC--Light Cure
SC--Self Cure
TABLE-US-00022 TABLE 2 CEMENT PROPERTIES Fracture Plexural Bond
Strength/ Solubility Toughness Strength Cement Supplier Product
Adhesion MPa (psi) (H.sub.2O %) (MPa-m.sup.1/2) MPa (ksi) Zinc
Phosphate (general data) (general data) -- 2 -- -- Ormco Zinc
Phosphate Enamel: <0.689 (100) 0.5 -- -- SS: 0 Ormco Protech
Gold Enamel: 4.14 (600) -- -- -- SS: 0.689 (100) Glass Ionomer
(general data) (general data) -- -- -- -- Pulpdent GlassCore -- --
-- -- Pulpdent GlassBase 0.17 0.33 3M Ketac-Cem -- -- -- 15 .+-. 5
(2.18 .+-. 0.7) 3M Ketac-Molar -- -- 0.78 33 (4.79) 3M
VitremerLuting -- -- -- -- RRGI 3M Vitrebond -- -- -- -- Bisco
Illusion -- -- -- 100 (14.5) Bisco C&B -- -- -- 113 (16.4)
Resin 3M RelyX ARC -- -- -- J. Morita Bistite II DC Co--Cr alloy:
-- -- 98 22.8 (3306) Au--Pd alloy: 22.9 (3321) J. Morita M-Bond --
-- -- 56 *No fatigue data available from the companies *No shrink
rate or shrinkage available *No electrical conductivity data
Zinc Phosphate
General Description
[0117] This type of cement is typically hard and rigid and it bonds
through mechanical means. Currently, the cement is used in the
dentistry area for well-fitting posts, crowns, metal inlays, and
aluminous all-ceramic crowns. The typical material specifications
are as follows: compressive strength 80-110 MPa (11.60-15.95 ksi),
tensile strength 5-7 MPa (725-1015 psi), and modulus of elasticity
13 GPa (1.89*10.sup.6 psi) One of the disadvantages to this kind of
cement is that the setting time is often slow. The cement is
gradually soluble in oral fluids and can be an irritation to pulp.
Zinc phosphate cement is becoming obsolete in the dentistry area
due to these complications.
Suppliers
[0118] Two suppliers were found for zinc phosphate cements, Mizzy,
Inc. and Masel. Little information regarding these suppliers with
regard to this cement was found. Masel was contacted about further
information, but there has been no response.
Glass Ionomer (GI)
General Description
[0119] There are many types of glass ionomer cements on the market
that are used for dentistry work. These cements typically bond to
the tooth structure through ionic means. The compressive strength
generally ranges from 90-230 MPa (13.05-33.36 ksi). The elastic
modulus is lower resulting in the material being susceptible to
elastic deformation in high stress regions.sup.2. They are fairly
inexpensive, but typically have a low resistance to mechanical
wear.
[0120] In general this kind of cement is technique-sensitive. In
one study comparing glass ionomer to composites, it was determined
that the failure rate for the glass ionomer was much higher. This
is probably due to the fact the cement requires little moisture
exposure for the first 24 hours, which is difficult in a clinical
setting. Tests were not done on light-cured glass ionomers, which
have a faster setting time.
Suppliers
[0121] Pulpdent sells six different kinds of glass ionomer cements
along with a few other types of cements. All of their GI cements
have a fluoride ion release and are acid-etchable. The cements have
a low thermal expansion coefficient (9-ppm). The bond strength is
high along with fairly high compressive and diametric tensile
strengths. Two of Pulpdent's GI cements that may be applicable to
use in this study are the GlassCore.TM. and the GlassBase.TM.. The
compressive strength for the GlassCore.TM. is 179 MPa (26,000 psi)
and for the GlassBase.TM. 227 MPa (33,000 psi).
Process Description
GlassCore
[0122] Pulpdent Bond Conditioner must first be applied to all
dentin and metal surfaces for 10 seconds. The powder portion and
liquid portion are mixed together for about 20 seconds. The working
time for this cement is 3 minutes and the initial setting time is 6
minutes from the finish of mixing.
GlassBase
[0122] [0123] Once again a Pulpdent Bond Conditioner is applied to
the surfaces and depending on the application a light cure bonding
resin may need to be added and cured. The mixing, working time, and
setting time are the same as with GlassCore.TM.. A light cure
bonding resin may be applied to the cement and to etched surfaces
afterwards.
[0124] Ketac-Cem, Ketac-Molar, and Vitremer Luting Cement are glass
ionomer cements from 3M. Ketac-Cem's powder portion is composed of
glass powder, polycarboxylic acid, and pigments. The liquid portion
is water, tartaric acid, and conservation agents. This luting
cement is used for the cementation of inlays, onlays, bridges, and
crowns with metal or ceramics and composite veneering. The
solubility in the oral environment is quite low with this cement.
The compressive and flexural strengths are high and it has a good
resistance to mechanical wear. The opacity is high at 230%
(relative to aluminum) and the biocompatibility is considered
acceptable. Ketac-Molar is a metal-free glass ionomer that is
designed as a filling material in the teeth, so the mechanical
properties and its radiopacity (260%-relative to aluminum) are
higher than Ketac-Cem. The compressive strength of this material is
230 MPa (33.36 ksi) and it has a flexural strength of 33 MPa (4786
ksi). Vitremer Luting Cement contains a powder and a liquid
portion. Fluoroaluminosilicate glass containing a microencapsulated
potassium persulfate, an ascorbic acid catalyst, and small amounts
of an opacifying agent make up the powder portion of this cement.
The liquid portion is a solution of polycarboxylic acid modified
with pendant methacrylate groups, HEMA, water, and minimal amount
of tartaric acid. Vitremer Luting Cement's applications include:
luting metal inlays, onlays or crowns, cementation of porcelain
fused-to-metal crowns, pre-fabricated and cast post cementation,
and luting orthodontic appliances. This product does not have any
measurable solubility like most GI cements. The fracture toughness
of this cement is higher than other GI products as well.
Process Description
Ketac-Cem
[0125] All enamel, dentin and metal surfaces must be cleaned and
dried before cement can be used. Dentin can not be exposed to the
cement directly so the surface must be coated with a calcium
hydroxide preparation. The powder and liquid portions are then
mixed together for about 30 seconds. The working time is 3 minutes
and the setting takes place in 7 minutes from start of mixing.
Ketac-Molar
[0125] [0126] No information on instructions for use of this
product.
Vitremer Luting Cement
[0126] [0127] The surfaces of the inlays, onlays or crowns must all
be thoroughly cleaned before the procedure. The pulp needs to be
protected as with the Ketac-Cem. The powder and liquid portions are
mixed together for 30 seconds. Once mixing is completed the cement
has a working time of 2.5 minutes and then after placement setting
will occur in 3 minutes. This product does not have to be light
cured. Dentsply-Sankin makes a glass ionomer cement that can be
used as both a luting and a base cement. The product claims to have
excellent biocompatibility and a compressive strength up to 190 MPa
(27.56 ksi). No further information about properties or process
description was received from the company.
Resin Reinforced Glass Ionomer (RRGI)
General Description
[0128] Resin reinforced glass ionomer cements (or resin-modified)
have higher strengths (both compressive and tensile) and a lower
solubility than regular glass ionomers. Their adhesion properties
are similar to glass ionomers. There is some concern with using
this product for cementing posts due to a possible
expansion-induced fracture.sup.2.
Suppliers
[0129] 3M has a resin modified glass ionomer (RMGI) liner/base
material called Vitrebond. The recommended use for this material is
as a liner or base under metal, ceramic, composite, and amalgam
restorations. The powder component is composed of SiO.sub.2,
AlF.sub.3, ZnO, SrO, cyrolite, NH.sub.4F, MgO, and P.sub.2O.sub.5,
which are all fused together. The powder is radiopaque. A modified
polyacrylic acid with pendant methacrylate groups, HEMA, water, and
photoinitiator make up the liquid component. Both components are
light sensitive. Unlike many GI cements, the Vitrebond sets with a
brief exposure to light. The compressive strength is 96.5 MPa (14.0
ksi), diametrical tensile strength is 17.4 MPa (2.52 ksi), and the
flexural strength is 25.5 MPa (3.70 ksi). The radiopacity of this
material is 1.6 (relative to aluminum). Vitrebond has passed
cytotoxicity, mucosal irritation, primary skin irritation, and
Magnussan-Klingman sensitization tests. It is not recommended for
direct pulp capping.
Process Description
Vitrebond
[0130] The powder and liquid portions are mixed together. Since the
product is light cured, setting does not occur until light exposure
so the working time is flexible and setting occurs immediately when
the user is ready.
[0131] GC America, Inc. makes a few reinforced glass ionomer
cements. GC FujiCEM is recommended for the final cementation of
resin crowns, metal, porcelain fused to metal, bridges, inlays, and
ceramic inlays. The preparation for this material takes very little
time. This cement has two paste components as opposed to the
typical powder/liquid combination. The film thickness is very low
in comparison with glass ionomer cements and other resin reinforced
cements. Clinically, this cement is insoluble once it is set, which
reduces the chance of microleakage or washout. The material is
considered biocompatible and radiopaque. GC Fuji PLUS bonds both
chemically and mechanically to all types of core materials. This
cement can be used for final cementation of metal or porcelain
fused to metal bridges, crowns, inlays, or onlays. The product
claims to have excellent bond strength and to be clinically
insoluble. GC Fuji ORTHO comes in either a light-cure (LC) or
self-cure (SC) cement. The ORTHO LC is used to bond metal,
porcelain and polycarbonate brackets and metal bands to enamel.
This product has a low sensitivity to moisture. ORTHO LC can be
purchased in capsules or as a powder-liquid component. ORTHO SC
bonds brackets, bands, and acrylic appliances. With both of these
products the technique is simplified, no etch is required, and the
success rate is high.
Process Description
GC FujiCEM
[0132] The two pastes are mixed together in 10 seconds either by
hand or with a Paste Pak Dispenser. There is a 3-minute working
time and 1.5 minutes after this for removal of cement before
setting.
GC Fuji PLUS
[0132] [0133] Optionally, Fuji PLUS Conditioner can be used on the
bonding surface to increase the bond strength and reduce chance of
pulp irritation. The cement is then applied within the working time
of 2.5 minutes. Any excess cement must be removed within 30 seconds
before final setting occurs.
GC Fuji ORTHO LC and SC
[0133] [0134] No instructions available at this time.
[0135] Bisco, Inc. produces Illusion.TM. for cementation of
porcelain and composite veneers, crowns, inlays, onlays, and
metallic crowns, inlays, and onlays. The composition of
Illusion.TM. is 15-30% Ethoxylated Bisphenol-A-dimethacrylate,
60-70% glass filler and 5-12% Triethyleneglycol dimethacrylate.
C&B Opaque is also made by Bisco and is commonly used for metal
crowns, inlays, onlays and restorations. The cement catalyst
portion is composed of three ingredients: 30-600 silica, 30-60%
Bisphenol-A-diglycidylmethacrylate and 5-15%
Triethyleneglycoldimethacrylate. The cement base is composed of
8-30% Bisphenol-A-diglycidylmethacrylate, 8-301 Ethoxylated
Bisphenol-A-dimethacrylate, 15-40% silica, 15-40% glass frit and
less than 1% sodium fluoride.
Process Description
Illusion
[0136] The process varies depending on what kind of cementation is
done. With metal restorations, the surface should be sandblasted
for 1-2 seconds and then rinsed with water and air-dried. Two coats
of ONE-STEP adhesive should be applied to the surface. The Base and
Catalyst Pastes should be mi xed together and placed on the
appropriate surface.
C&B Opaque
[0136] [0137] The metal surface should be sandblasted before
beginning. An adhesive, like ONE-STEP or ALL-BOND 2 should be
applied before cementation. The working time for this product is 3
minutes and the setting time is 4.5 minutes.
Polycarboxylate Cement
General Description
[0138] This type of cement is used in the dentistry area because it
adheres chemically to the tooth through an interaction of free
carboxylic acid groups with calcium. The compressive strength
(55-85 MPa; 7.98-12.33 ksi) is generally lower than that of the
zinc phosphate cements. However, the tensile strength is higher
(8-12 MPa; 1.16-1.74 ksi) and the plastic deformation is greater
with the polycarboxylate cements. This cement has been proven to be
biocompatible with dental pulp. The recommendation for this cement
is for single metal units in a low stress area with short span
prostheses.
Suppliers
[0139] L.D. Caulk produces Tylok Plus, an anhydrous polycarboxylate
cement, so only water is needed for mixing. Currently, it is used
for final cementation of crowns, bridges, and inlays. It could also
be used as a base or cavity liner under restorative materials. This
material is biocompatible against the pulp and bonds ionically to
the enamel and dentin. The minimum compressive strength for the
luting cement is 60 MPa (8.70 ksi) and for a base cement, 70 MPa
(10.15 ksi). However, according to the MSDS on this material,
irritation may occur to the soft tissue in the body, so this
product may not be applicable for use in a stent.
Process Description
Tylok Plus
[0140] The powder is mixed with water for 30 seconds. The minimum
working time is 1 min 45 seconds and the maximum setting time is 7
minutes.
Composites
General Description
[0141] Composite restorative materials are typically BIS_GMA/TEGMDA
resins filled with silanated silica or zirconia, barium glass for
radiopacity, colorants to match teeth photoinitiators and chemical
catalysts. Smaller cavities can be filled directly, usually light
cured, then shaped and polished. Indirect restorations (lab
produced) undergo further polymerization utilizing heat, pressure,
inert gas and various light sources. Composite Supreme from 3M
contains agglomerated nano-filler with a tensile strength of 90
MPa. Bisco Inc. makes the indirect lab composite Tescera atl with a
tensile strength of 64 MPa. Other lab composites include Sinfony by
3M ESPE (St. Paul, Minn.) and Belleglas by Kerr Sybron (Romuhus,
N.Y.). Sculpture by Pentron lab Technologies LLP is BIS-GMA free,
utilizing polycarbonate di-methacryate (PCDMA) and ethoxylated
biphenyl A di-methacrylate (EBPADMA) as the resin
Process Description
[0142] To make inlays, onlays and crowns of composites, an analog
of the prepared tooth is made of artificial stone from a mold taken
from the mouth. Material is packaged in a lightproof syringe. Small
increments are carried on the tip of the instrument and adapted to
prep the analog and then short bursts of light hold them in place.
Polymerization of surface is inhibited by atmospheric oxygen thus
allowing a complete bond to subsequent layers. When the form is
complete, the restoration can be fully cured using light, heat,
vacuum or an inert gas. For high stress applications (molars,
bridges, etc), high strength fibers are incorporated. Ribbond brand
(Seattle, Wash.) is made of Spectra from Allied Signal (Honeywell).
These fibers are plasma treated to allow a chemical bond to resins.
The modulus of elasticity is 24,000 ksi (165.5 GPa) and the tensile
strength is 3.51 GPa (509 ksi). One idea to increase the tensile
strength would be to stitch prongs together with high strength
fiber. A bundle of fiber drawn through the restoration is fully
cured using light, heat, vacuum or an inert gas in cure the oxygen
inhibited layer. A hole in the prong could be anchored and encased
with polymer. Or prongs with a serrated profile could be coated
with resin cement for insulation and then placed together side by
side, wrapped with fibers and then encased in a drop of
polymer.
Color Shade Effect on Strength
[0143] While dental material suppliers want to make strong
composite systems, optical properties to match teeth must be
considered. Adding opacifiers, pigments, fluorescent agents, and
adjusting filler loading can lead to translucence. Studies show
that strength varies with shade and translucency. If the formula is
adjusted for maximum strength disregarding appearance, the physical
properties should be improved.
Cyanoacrylates
General Description
[0144] Cyanoacrylates are commonly used as super glue.
Polymerization occurs by a rapid anionic mechanism with the aid of
a weak base like water. The bond formed with cyanoacrylates is very
strong. One downfall with this type of cement is that in some cases
they have been found to be carcinogenic. Methyl cyanoacrylate
causes an acute inflammatory response as a result of formaldehyde
that is left behind. Currently, n-butyl cyanoacrylate and
2-octylcyanoacrylate have been approved for use in the United
States. This material is mainly used for soft tissue adhesion, like
treating lacerations.
Suppliers
[0145] There were no suppliers found for cyanoacrylates cements
that are currently used in the medical field.
Resin Composite Cements
General Description
[0146] This type of cement typically combines filled
Bisphenol-A-glycidyldimethacrylate (BIS-GMA) resin with different
methacrylics. Polymerization can occur through photopolymerization,
chemical mechanisms, or through a combination of both. The cement
has a higher strength than the glass ionomer cements and it is also
insoluble in the oral cavity. One draw back of this type of cement
is that the process is technique sensitive.
Suppliers
[0147] J. Morita USA supplies several different types of cements,
including Bistite II DC and M-Bond. Bistite II DC is self-etching,
dual-cured, resin cement that can be used for many procedures. This
product can be used for cementation of metal crowns, inlays,
onlays, and adhesion bridges and for cast posts and cores. Ceramic
crowns, inlays, onlays, bridges, and veneers and composite crowns,
inlays, and onlays can also be cemented with this material. This
material has a low film thickness and high bond strength to dentin.
The Bistite II DC is composed of 77% silica based fillers and 23%
methacrylate. M-Bond is composed of 48% acetone and 52%
methacrylates, isopropanol, and phosphoric acid monomer. It was
designed for restorations that demand sufficient elasticity
(Maryland bridges). This product can also be used for both metal
and ceramic restorations (inlays, onlays, bridges, and crowns) cast
posts and cores. M-Bond has high bonding strength and a better
adhesion to metal.
Process Description
Bistite II DC
[0148] For both ceramic and metal restorations the surface should
be sandblasted, ultrasonically cleaned and dried. For the precious
metal components used the surface should be treated with METALTITE.
With ceramic components TOKUSO CERAMIC PRIMER should be applied to
the surface and allowed to dry for 10 seconds. The two pastes are
then mixed together for 10 seconds and then apply the cement
(working time=4 minutes). The cement self cures and sets in 8
minutes 40 seconds.
M-BOND:
[0148] [0149] Ceramic and metal prosthesis should be alumina
sandblasted, ultrasonically cleaned, and dried. Precious metal
alloys should then be treated with METALTITE. For ceramic
components the surface should be treated with TOKUSO CERAMIC
PRIMER. The cement is mixed and the working time is 1 minute 40
seconds. Slight pressure should be applied while the cement is
allowed to set which should take 4 minutes.
[0150] 3M ESPE produces a RelyX ARC (Adhesive Resin Cement), which
is a dual-cure resin cement. It is commonly used for bonding
crowns, bridges, inlays, onlays and endodontic post cementation.
These restorations can be porcelain, ceramic, composite, metal or
porcelain-fused-to-metal. The resin component contains BIS-GMA and
triethylene glycol dimethacrylate (TEGDMA), along with
zirconia/silica and fumed silica fillers for radiopacity, strength,
and wear resistance. The cement is also composed of a
dimethacrylate polymer, for easy flow while still maintaining
shape, pigments, and a photoinitiator. The flexural strength of
RelyX is 123 MPa (17.84 ksi), the compressive strength is 345.7 MPa
(50.14 ksi), and the diametrical tensile strength is 77.6 MPa
(11.25 ksi). The solubility for this cement is 0.3 .mu.g/mm.sup.3,
the water sorption is 29 .mu.g/mm.sup.3, and the wear rate is 1
.mu.m/10,000 cycles.
Process Description
RelyX ARC
[0151] The procedures all vary slightly depending on what kind of a
restoration is used. Metal surfaces need to be abraded. Two coats
of Single Bond adhesive should be used on the enamel and dentin
surfaces. The cement should be mixed for 10 seconds and applied to
the surface. Once the restoration is in place and excess cement
removed, light curing takes place for 40 seconds or it can be self
cured in 10 minutes.
Other Notes on Resin Cement
[0152] Taira et al investigated the bond strength of four resin
cements and three primers to sandblasted titanium before and after
100,000 thermocycles. Two of the combinations were in the 50 MPa
range: Panavia 21 ((Kuraray Okayoma, Japan) with metal primer 2 (GC
Corp Toyko) and Imperva duel (Shofu Inc. Kyoto, Japan) with metal
primer 2. Both of these cements offer easier handing. Panavia is a
two-part paste in an auto dispenser. It develops final cure when
deprived of oxygen with a gel called oxyguard. For purposes related
to this investigation an inert gas purge could possibly be used.
Imperva, as a duel cure, allows manipulation until exposed to the
correct wavelength of light. Chang et al conducted a literature
review of studies on 4 META use in dentistry. This report indicates
the results of studies of resin bonding to many metals and one
ceramic and also discusses other adhesive monomers.
[0153] If a composite is deemed strong enough to bridge the gap
between metal struts, the special monomers contained in some of the
resin cements may be necessary to chemically bond to metal. The
bond mechanism of these resins requires an oxide film on metal. For
non-reactive metals like gold, and possibly tantalum, a surface
treatment is needed. Methods investigated in dentistry to increase
the bond strength and reduce microleakage, include electroplating
or sputter coating with tin chromium, nickel, etc.
Tests
[0154] Samples of stainless steel and tantalum were laser cut with
struts facing each other in butt fashion. After experimenting on
scraps cut from sheet stock with various surface treatments and
carious ceramic/liquid combinations, J. Heggestuen made 10
connected stainless steel coupons. This was done by air abrading
the strut tips with alumina to remove any dross and to also aid in
wetting. Creation Glaze (Klema, Austria) was used due to its
submicron frit and low firing temperature. Proform 10 modeling
liquid (Renfort, Germany) was used to aid shaping and prevent
evaporation. A small drop of mixed slurry was taken up on the tip
of a single sable bristle under a microscope and positioned to
bridge the gap. Slight vibration was applied to allow the surface
tension to pull the mixture into a sphere. Samples were dried and
placed into the furnace at 842.degree. F., a vacuum was applied and
the temperature was raised to 1272.degree. F. at a rate of
100.degree. F. per minute. The vacuum was released and held for one
minute and then removed and allowed to cool.
CONCLUSION
[0155] Sample connections appeared smooth and pore free. Some of
the samples performed well in pull tests at Scimed. J. Heggestuen
believes that further investigation will lead to higher strengths
with smaller dimensions at lower firing temperatures. The attempts
to fire porcelain to tantalum resulted in damage to the metal with
a scaly non-adherent reaction layer. Vita Titatium bonding agent
was used. The intended use for this product is to control oxide
formation. Firing at temperatures of 1472.degree. F. left the
tantalum brittle. Porcelain systems for bonding to titanium have
demonstrated sufficient strength for dental applications. These
systems include Vitals titan Keramic, Noritake super porcelain
Ti-22, and Nobel Biocare Ticeram. To avoid affecting the chemistry
of the metal a laser could possibly vitrify the ceramic connector.
Dental lasers are equipped with microscopes and routinely can weld
chrome cobalt within a few hundred microns from the acrylic. To
demonstrate whether these techniques could be applied to make an
electrically insulating, biocompatible, strong connection to metal
a test was devised.
Ceramic to Metal
[0156] Tests were conducted to bond ceramic to metal at his dental
research lab. Tantalum wire with a diameter of 0.015 inches was
bonded to custom-made ceramic coupons. Fifteen samples were made
using C&B Metabond made by Sun Medical. Coupons were made and
ground flat on the area that was to be bonded and then glazed.
Three different groups (5 samples each) were prepared with
different treatments. The first group was cleaned and bonded. The
next group was cleaned, the metal was primed with Metal Primer II
(Meps--GC America) and the ceramics with etch free (4 Meta--Parkell
Biomaterials). The final group was media blasted and no primers
were used. A length of the wire (0.23-0.37 in.) was bonded to the
top surface of the ceramic. MTS tests were attempted on these
samples by gripping the ceramic on the bottom and pulling the wire
from the top. Due to the way the two materials were bonded this
type of test would indicate a shear stress more than a tensile
stress. Unfortunately, tests on these samples were not successful.
It was difficult to strongly grip the ceramic without breaking it;
however, if the sample was not held strong enough the sample would
simply slip out of the gripper during the tests. After several
attempts with different grippers, it was determined that accurate
results could not be found with this method. It was requested to J.
Heggestuen that different samples be made. First going to bond
tantalum wire face to face with each other to focus on the cement
bond strength. These tests will also be done with titanium wire. If
through these tests it is determined that the cement strength is
high enough further tests can be done to decide if a stent can
function appropriately with a simple cement bond holding the struts
together. Further tests can also be done to determine the strength
with ceramic bonded to metal through cementation.
Metal to Metal
[0157] Using the sample cements that were sent from J. Morita
(M-Bond) and Bisco (C&B) tests were conducted. Tantalum wire
(0.020-inch diameter) was used for these tests. Half-inch sections
were cut and ground with 800-grit paper. Different methods were
tried in order to find a way to bond the wire face-to-face. It was
finally decided that aluminum blocks with a slit cut to the
0.02-inch diameter would work the best to cement the samples
together. Tensile tests were done on 5 of the M-Bond specimens, but
results were hard to calculate because the cement was not uniform
on the samples and accounted for more surface area than the wire
face. With a rough estimation that the cement was twice the
diameter of the wire, it was determined that the tensile strength
was between 3000-3800 psi. If this number is accurate, it is not
high enough for the required stress of 10 ksi. However, several
factors could influence these results including; incorrect surface
area, surface not sandblasted (as recommended by the suppliers),
and no primer was used. At this point one can not accept nor
eliminate cementation as a possible method. The detailed
descriptions of the tests that were attempted to cement the wire
together are given in the Appendix.
Ground Metal
[0158] Currently, Ti-6Al-4V wire (diameter 0.010 inch) is being
ground down at the ends to a diameter of 0.006 inches. There will
be a step down from the higher diameter to the lower one. The
smaller ground portion will have a length of about 1-inch, which
can be cut to a specific length at a later point. These wire pieces
can be used to test the design idea of having a narrowed portion in
the stent where ceramic can be fired on and then laser portion a
section out [FIG. 4]. Once these wire pieces are obtained, a way to
fire on the ceramic must be determined and tested.
* * * * *
References