U.S. patent application number 15/344066 was filed with the patent office on 2017-02-23 for inflatable medical devices.
The applicant listed for this patent is LOMA VISTA MEDICAL, INC.. Invention is credited to Christopher Michael ADAMS, Roland J. DOWNS, Jon Michael HOLWEGER, Mark Christopher Scheeff, Alexander Quillin Tilson.
Application Number | 20170050004 15/344066 |
Document ID | / |
Family ID | 41380699 |
Filed Date | 2017-02-23 |
United States Patent
Application |
20170050004 |
Kind Code |
A1 |
Tilson; Alexander Quillin ;
et al. |
February 23, 2017 |
INFLATABLE MEDICAL DEVICES
Abstract
Inflatable medical devices and methods for making and using the
same are disclosed. The inflatable medical devices can be medical
balloons. The balloons can be configured to have a through-lumen or
no through-lumen and a wide variety of geometries. The device can
have a high-strength, non-compliant, fiber-reinforced,
multi-layered wall. The inflatable medical device can be used for
angioplasty, kyphoplasty, percutaneous aortic valve replacement, or
other procedures described herein.
Inventors: |
Tilson; Alexander Quillin;
(Burlingame, CA) ; Scheeff; Mark Christopher; (San
Francisco, CA) ; DOWNS; Roland J.; (Mesa, AZ)
; ADAMS; Christopher Michael; (Tempe, AZ) ;
HOLWEGER; Jon Michael; (Queen Creek, AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
LOMA VISTA MEDICAL, INC. |
Tempe |
AZ |
US |
|
|
Family ID: |
41380699 |
Appl. No.: |
15/344066 |
Filed: |
November 4, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12477077 |
Jun 2, 2009 |
9504811 |
|
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15344066 |
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|
61205866 |
Jan 22, 2009 |
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61105385 |
Oct 14, 2008 |
|
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|
61086739 |
Aug 6, 2008 |
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61057986 |
Jun 2, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/8855 20130101;
A61M 2025/1093 20130101; A61B 2017/00783 20130101; A61M 25/1002
20130101; A61M 2210/125 20130101; A61M 2025/1072 20130101; A61M
2025/1097 20130101; A61M 29/02 20130101; A61F 5/0036 20130101; A61M
2025/1086 20130101; A61M 2025/1088 20130101; A61B 17/8827 20130101;
A61M 25/1029 20130101; A61M 25/0147 20130101; A61B 17/8816
20130101; B29C 41/04 20130101; Y10T 156/108 20150115; A61M 25/1027
20130101; A61M 2025/1075 20130101; A61B 17/8833 20130101; B29C
41/14 20130101; Y10T 156/1028 20150115; A61M 2025/1031 20130101;
A61M 2210/02 20130101 |
International
Class: |
A61M 29/02 20060101
A61M029/02; A61M 25/10 20060101 A61M025/10; A61B 17/88 20060101
A61B017/88 |
Claims
1. A medical balloon for performing an angioplasty, comprising: a
body including a wall having an inner layer, an outer layer, and an
intermediate layer at least partially between the inner and outer
layer, at least the intermediate layer comprising a radiopaque
foil.
2. The balloon of claim 1, further including an adhesive for
laminating the foil to the inner or outer layer.
3. The balloon of claim 1, wherein the foil is provided on a first
portion of the balloon.
4. The balloon of claim 3, wherein the first portion comprises a
cylindrical portion of the balloon.
5. The balloon of claim 3, wherein the first portion comprises a
tapered portion of the balloon.
6. The balloon of claim 1, wherein a fiber is provided between the
inner layer and the outer layer.
7. The balloon of claim 1, wherein the foil comprises a material
selected from the group consisting of gold, platinum,
platinum-iridium alloy, tantalum, palladium, bismuth, barium,
tungsten, or combinations thereof.
8. The balloon of claim 1, wherein the foil is less than about 30
.mu.m thick
9. The balloon of claim 1, wherein the foil is less than about 20
.mu.m thick.
10. The balloon of claim 1, wherein the foil is about 15 .mu.m
thick.
11. The balloon of claim 1, wherein the foil is about 12 .mu.m
thick.
12. The balloon of claim 1, wherein the foil is about 10 .mu.m
thick.
13. The balloon of claim 1, wherein the foil is about 8 .mu.m
thick.
14. The balloon of claim 1, wherein the body is non-compliant.
15. A medical balloon for performing an angioplasty, comprising: a
body including a wall having an inner layer, an outer layer, and a
radiopaque foil therebetween.
16. The balloon of claim 15, wherein the radiopaque foil comprises
a single continuous layer.
17. An apparatus comprising: a medical balloon; and a radiopaque
foil having a removable backing.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application No. 61/057,986, filed 2 Jun. 2008; 61/086,739, filed 6
Aug. 2008; 61/105,385, filed 14 Oct. 2008; and 61/205,866, filed 22
Jan. 2009 which are incorporated by reference herein in their
entireties. This application is a continuation of U.S. patent
application Ser. No. 12/477,077, filed 2 Jun. 2009, the disclosure
of which is incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to inflatable structures for use in
medicine and other applications, and methods of manufacture and use
of the same.
[0004] 2. Description of the Related Art
[0005] Inflatable structures, such as balloons, are widely used in
medical procedures. A balloon is inserted, typically on the end of
a catheter, until the balloon reaches the area of interest. Adding
pressure to the balloon causes the balloon to inflate. In one
variation of use, the balloon creates a space inside the body when
the balloon inflates.
[0006] Balloons may be used to move plaque away from the center of
a vascular lumen toward the vasculature walls, such as during an
angioplasty or a peripheral vasculature procedure. During this
procedure, a balloon tipped catheter is placed in a vascular
obstruction. As the balloon is inflated, the vessel constriction is
dilated, resulting in improved blood flow.
[0007] Optionally, the balloon may have a stent placed over it. The
balloon expands the stent in order to create a scaffold structure
that keeps the vessel from constricting after the balloon is
removed. Stents are used throughout the body, including the
coronaries, other portions of the vasculature, the GI tract, the
biliary ducts and the urinary and gynecologic tracts.
[0008] High pressure balloons may be used to expand constrictions
in bone, such as in the sinuses in sinuplasty.
[0009] Balloons may be designed to make space in bone. After an
osteoporotic compression or trauma-induced fracture in a vertebral
body, a balloon can be inserted into the vertebral body through a
working channel such as a cannula. The balloon is then inflated,
creating a void in the bone. The balloon is withdrawn and bone
cement is injected to internally stabilize the fracture. This
procedure may be referred to as Kyphoplasty.
[0010] Sometimes the vasculature has a narrowing that is calcified,
which can create a particularly difficult obstruction for dilation.
As the vessel is increasingly narrowed, it can become what is known
as a CTO (Chronic Total Occlusion). CTOs can be difficult to pass
through with a device such as a guidewire or catheter and can be
difficult to dilate or open. The balloon used to open a CTO is
ideally resistant to puncture and operates at a very high
pressure.
[0011] Balloons can have structures attached to their surface.
These structures can include blades or stiffening rods. These
structures may slice a vessel open. These structures may apply
pressure to the inside of a vessel in order to expand the
vessel.
[0012] Balloons can be used to locally deliver captured volumes of
a radioactive substance. The procedure may be known as
brachytherapy.
[0013] Balloons can be used to intentionally obstruct vessels.
Stenting of the carotids serves to treat atherosclerotic carotid
vessels. Stenting of the carotids may be less invasive than an
endarterectomy. Stenting of the carotids may release a stream of
debris that can travel to the brain, causing strokes. Expanding a
balloon in the carotid artery above the area of treatment can
prevent this debris movement to the brain, thereby reducing the
potential for adverse complications.
[0014] Balloons may be used to position and deploy arterial grafts
that repair aneurysms.
[0015] A balloon may deliver targeted drugs in the body by
isolating a space for treatment.
[0016] A balloon may deliver targeted drugs in the body by having
many tiny holes in the balloon wall. The holes in the balloon wall
may allow the drug to slowly flow into the area surrounding the
balloon.
[0017] Balloons may be used endoscopically to open up constrictions
in the body, such as those in the esophageal tract, the urological
tract, the biliary tract, the fallopian tubes, the carpal tunnel or
esophagus, or other portions of the GI tract (the alimentary
canal). A balloon may be used to expand constrictions in the
urethra, including for Benign Prostate Hyperplasia (BPH).
[0018] Balloons may be used in the heart valves, including during
Percutaneous Transvenous Mitral Valvuloplasty (PTMV) or
Percutaneous Transvenous Mitral Balloon Commissurotomy (PTMC) or
Mitral Annuloplasty. The balloons can be utilized to expand
stenosed or calcifically-narrowed structures. The balloons can be
utilized to expand valves to a tissue-opposed diameter.
[0019] A balloon may be used to affix a device inside the body.
Another device may then use the balloon as a structure that the
device can react against. The device may use this reaction force to
move in the body. A balloon and a device may be used in the GI
tract. A balloon and a device may be used during a Double Balloon
Enteroscopy procedure, or during colonoscopy.
[0020] Balloons may be used to create space in the body or to move
organs in body. Balloons can be used to manipulate organs along
tissue planes.
[0021] The balloon may locate a cutting instrument in some ablative
procedures. The balloon may position a diagnostic device.
[0022] An inflatable structure can be used to open space in tissue
or to pull sclerotic structures apart, or to advance structures
introduced herewithin to the body.
[0023] A balloon may be used to occupy a volumetric space for long
periods of time, such as a device used to impart satiety at lower
food volumes, as in Bariatric procedures.
[0024] A balloon can be used to create captured volumes that serve
to transfer heat or cold. A balloon can provide small crossing
profiles that then expand locally to create large volumes with high
surface areas and intimate tissue contact. This is utilized in the
prostate to treat BPH.
[0025] Balloons can be used as implants, creating an anatomical
conforming structure advantageous to improved local fit.
[0026] Balloons have been suggested which seal against a lumen
wall, then continue to dynamically seal as they are manipulated
backwards or forwards. These balloons may be used in the GI tract.
These balloons may be advanced forward or backward by pressure
gradients on either side of the balloon.
[0027] Balloons may be used as pressure cuffs, such as those found
in Lap-Band bariatric devices. By changing the pressure in the
balloon, the inner diameter can grow or shrink. Changing the
diameter alters clinical results.
[0028] Balloons may be elongated and used for movement, through
long lumens, including the GI tract.
[0029] Inflatable structures can be made into everting tubes, which
have been utilized in gynecologic and urinary procedures, and have
been suggested for GI procedures.
[0030] Two basic types of balloons are utilized: One is a high
pressure, low-compliance balloon. The other is a lower pressure,
high-compliance balloon.
[0031] High-compliance medical balloons are often composed of
urethane, latex, silicone, PVC, Pebax, and other elastomers. As the
pressure in a high-compliant balloon is increased, the balloon
dimensions expand. Once the pressure is reduced, the
high-compliance medical balloon may return to its original shape,
or near its original shape. High-compliance medical balloons can
easily expand several times in volume between zero inflation
pressure and burst.
[0032] Traditional high-compliance medical balloons can be
inadequate for many reasons. High-compliance, or highly elastic
medical balloons typically cannot reach high pressures because
their walls have a low tensile strength and their walls thin out as
the balloon expands. In some instances, high-compliance medical
balloons provide insufficient force to complete a procedure.
Exceeding the rated pressure of a high-compliance medical balloon
creates an excessive risk of balloon failure which can lead to
serious complications for the patient.
[0033] High-compliance medical balloons also have poor shape
control. As a high-compliance medical balloon expands, it may
assume a shape dictated mostly by the particulars of the
environment inside the patient rather than the clinical goals. In
some cases, this can be contrary to what the medical practitioner
desires. Many medical procedures are predicated on forming a
particular balloon shape reliably.
[0034] High-compliance medical balloons often suffer from poor
puncture resistance.
[0035] It is generally desirable that the medical balloon be able
to enter and exit the body with as little trauma as possible.
Therefore, a small deflated balloon profile is an important
consideration in balloon design. This requirement favors materials
with high strength to volume ratios. High-compliance medical
balloons do not use materials that have outstanding strength to
volume ratios.
[0036] In some cases, it is desirable that the medical balloon have
a strong chemical resistance. For instance, a principal component
of bone cement is methyl methacrylate, which readily degrades some
elastomers, such as urethane. Therefore, many high-compliance
medical balloons are not compatible with the introduction of
aspects of the procedure that the high-compliance medical balloon
is meant to support.
[0037] Low-compliance, high pressure medical balloons substantially
retain their shape under comparatively high pressures. PET
(polyethylene terephthalate) is the most common material for use in
high pressure low-compliance balloons. PET is commonly used for
high-performance angioplasty balloons. PET is stronger than other
polymers, can be molded into a variety of shapes and can be made
very thin (e.g., 5 .mu.m to 50 .mu.m (0.0002 in. to 0.002 in.)),
thus giving these balloons a low profile.
[0038] Balloons made from PET walls are fragile and prone to tears.
When pressed against a hard or sharp surface in the body, such as
bone, PET balloons have poor puncture resistance. PET is very stiff
so balloons made from PET may be difficult to pack or fold into a
small diameter or with good trackability (i.e., the ability to
slide and bend over a guidewire deployed through a tortuous
vessel). In some applications, PET's chemical resistance can lead
to unwanted adhesion, degradation or destruction of a PET balloon
during a procedure.
[0039] Balloons made from PET, while stronger than most other
balloons made from homogenous polymers, may still not be strong
enough to hold pressures sufficient to complete certain medical
procedures.
[0040] The PET in a balloon wall may be oriented during
manufacture. However, the oriented PET may not have strength in all
directions exactly proportionate to the expected load.
[0041] PET, like most low compliance balloons, is usually
blow-molded. The blow molding process makes it difficult or
impossible to create certain shapes. Blow molding can result in
wall thicknesses in the balloon that do not match the material
thicknesses to the expected load.
[0042] Nylon balloons are an alternative material for
low-compliance, high pressure balloons. These balloons are
typically weaker than PET balloons and so can contain less
pressure. Nylon readily absorbs water, which can have an adverse
affect on Nylon's material properties in some circumstances. Nylon
has improved puncture resistance over PET and is more flexible than
PET.
[0043] Low compliance fiber reinforced medical balloons have
recently become commercially available for peripheral vascular
procedures. High strength inelastic fibers are used as part of the
low compliance fiber reinforced medical balloons to strengthen the
walls of the balloon while further lowering strain rates. High
strength inelastic fibers such as Kevlar, Vectran, Dyneema and
carbon fiber all have strength to volume ratios that greatly exceed
that of PET or Nylon. The high strength inelastic fibers are
combined with a flexible adhesive and, optionally, one or more
polymer walls to form a balloon.
[0044] Low compliance fiber reinforced medical balloons may suffer
from several problems. These balloons may have a low volume ratio
of high strength inelastic fiber to the total material volume in
the balloon walls. It is reasonable to assume that a higher volume
ratio of high strength inelastic fiber to the total material volume
in the balloon walls would lead to a higher burst pressure for the
same wall thickness.
[0045] Commercially available low compliance fiber reinforced
medical balloons and the processes that produce them may only allow
limited flexibility in the placement of the high strength inelastic
fibers. For example, a process may result in fibers aligned along
the axis of the balloon and fibers wrapped around the
circumference. This limited choice of fiber orientation is not
always the optimum way to orient the fibers for maximum strength.
This limited choice of fiber orientation is not always the optimum
way to orient fibers to resist puncture or ripping.
[0046] Commercially available low compliance fiber reinforced
medical balloons and the processes that produce them may not allow
for a large variety of different balloon shapes to be
manufactured.
SUMMARY OF THE INVENTION
[0047] Medical inflatable devices for use in a biological body are
disclosed. The device can have a balloon. The balloon can have a
wall having an inner layer, a first middle layer, and an outer
layer. The outer layer can be thinner than about 0.05 mm (0.002
in.), and the inner layer is thinner than about 0.05 mm (0.002
in.). The first middle layer can have a fiber. The outer layer can
have a melt or decomposition temperature greater than about
200.degree. Celsius.
[0048] The outer layer can be made from a thermoset material. The
outer layer can be made from PEEK. The outer layer can be made from
a polyamide. The outer layer can be MMA-resistant and/or
MMA-releasing. An MMA-resistant layer can be substantially
non-degrading when exposed to MMA, such as uncured MMA. An
MMA-releasing layer can be substantially non-binding or
non-adhering to MMA. The MMA-releasing layer can be pulled away and
separated from cured MMA without binding to the MMA.
[0049] The first middle layer can be made from a resin. The inner
layer can be thinner than about 0.01 mm (0.0004 in.), and the outer
layer can be thinner than about 0.01 mm (0.0004 in.). The inner
layer can be substantially air leak-proof.
[0050] The balloon can have a wall that can have an inner layer, a
first middle layer, and an outer layer.
[0051] The outer layer can be thinner than about 0.05 mm (0.002
in.). The outer layer can have a thermoset material, such as PEEK.
The outer layer can have a polyamide. The first middle layer can
have a fiber and/or a resin.
[0052] The wall can have an air leak-proof inner layer and an
MMA-resistant outer layer. The outer layer can be thinner than
about 0.05 mm (0.002 in.), and the inner layer can be thinner than
about 0.05 mm (0.002 in.).
[0053] The second layer can be radially inside the third layer, and
the second layer can be radially outside the first layer. The third
layer can make up the radial outermost surface of the wall. The
wall can also have a fourth layer. The fourth layer can be radially
inside the third layer. The fourth layer can be radially outside
the first layer. The fourth layer can have a radiopaque
material.
[0054] The wall can have a first layer, a second layer, a third
layer, and a fourth layer. The first layer can be leak-proof and
the fourth layer is MMA-resistant. The first layer can be radially
inside of the second layer, the third layer, and the fourth layer.
The fourth layer can be radially outside of the first layer, the
second layer, and the third layer. One, two, or three layers can
have resin and fiber in contact with the resin, for example the
fiber can be embedded within the resin or in one side of the resin.
The layers with the fiber can be MMA-resistant.
[0055] The wall can have a layer that can form at least one
continuous seam around the balloon. The balloon can be
substantially non-compliant or inelastic. The wall can be less than
about 0.1 mm (0.004 in.) thick.
[0056] The balloon can have a longitudinal axis having a
longitudinal axis length. The balloon can have a fiber having a
fiber length. The fiber length can be about 175% to about 300% of
the longitudinal axis length. The wall of the balloon can have a
first layer and a second layer. The fiber can be in the second
layer. The first layer can be on the radial inside of the fiber
with respect to the balloon, and the first layer can be leak-proof,
and/or MMA-resistant.
[0057] The balloon can have an inner diameter of more than about 2
mm, or about 13 mm (0.5 in.), or more than about 15 mm. The balloon
can have a wall having a wall thickness of less than about 0.005
in., and a burst pressure greater than about 150 psi, more narrowly
greater than about 3,400 kPa (500 psi). For example, the burst
pressure of the balloon can be greater than about 2,100 kPa (300
psi).
[0058] The balloon can have a proximal terminal end and a distal
terminal end. The balloon can have a closed distal terminal end, or
no through-lumen. Having no through-lumen can include having no
longitudinal through-lumen extending through the proximal terminal
end and through the distal terminal end. The distal end of the
balloon can be atraumatic, for example blunt.
[0059] The balloon can have a reinforcement fiber that can be in a
matrix. The matrix can have a reinforcement fiber and a resin. The
resin can be an adhesive. The fibers can be oriented longitudinally
and/or around the distal end of the balloon. The fibers can cover
(but not necessarily on the outer surface) greater than 50% of the
area of the balloon wall. The matrix can have a thermoplastic
material.
[0060] The balloon wall can have a first, second and/or more
strips. The strips can have none, one or more reinforcement and/or
radiopaque marker fibers. Each strip can have the same or a
different number of fibers. The balloon can have a closed distal
end. The first strip can overlay the second strip at the distal
end. Additional strips can overlay the first and second strips at
the distal end or elsewhere along the length of the balloon. The
strips can intersect at a strip angle. The strip angle can be equal
to or greater than about 30 or 45 degrees. For example, the strip
angle can be about 60 degrees or about 90 degrees.
[0061] The first middle layer can have a radiopaque material and be
substantially contiguous throughout the wall. For example, the
first middle layer can have a metal foil. The first middle layer
can have a radiopaque material in non-powder form. The first middle
layer can have less than about 100 pieces of radiopaque material.
The radiopaque material can covers (not necessarily on the top
surface) at least about 30% of the area of the wall of the balloon.
The first middle layer can have a first elongated member that can
have a radiopaque material. For example, the elongate member can be
a strip, such as the strip described herein.
[0062] The first middle layer can have a fiber. The second middle
layer can have a radiopaque material. The first middle layer can be
between the inner layer and the second middle layer.
[0063] The balloon wall can have a water-proof inner layer, a first
middle layer that can have a fiber, a second middle layer that can
have a radiopaque wire, and an outer layer. The fiber can be
helically positioned or hoop or helically wrapped around the
balloon wall.
[0064] The radially outer layer of the balloon wall can have a
thickness of less than about 0.0005 in. and the radially outer
layer can be resistant to degradation by MMA. The radially outer
layer can be made from or coated with Teflon or PTFE. The
MMA-resistant layer can have an MMA-resistant matrix and a fiber.
The MMA-resistant matrix can have an adhesive. The balloon can be
configured to deliver a radial pressure of about 2,800 kPa (400
psi).
[0065] The balloon can be shaped having a first side and a second
side. The first side can be opposite the second side with respect
to the balloon longitudinal axis. The first side can be
substantially flat, and the second side can be substantially
flat.
[0066] The balloon wall can have a wall thickness of equal to or
less than about 0.3 mm, for example about 0.1 mm, and the balloon
has an outer diameter less than or equal to about 13 mm, and the
balloon has a burst pressure of equal to or greater than about 1000
kPa (150 psi).
[0067] The balloon wall can have a first layer that can have a
reinforcement and/or marker fiber and a second layer that can have
a resistive heating element, such as tantalum foil. The resistive
heating element can be a wire helically configured around the
balloon. The resistive heating element can be controlled by a
controller configured to controllably deliver energy to the
resistive heating element. The resistive heating material can be
the elongated strip or in the elongated strip.
[0068] The wall can have a semi-rigid panel. The panel can be
between an inner and outer layer of the wall. The panel can have a
modulus of elasticity greater than about 1,000,000 and a thickness
greater than about 0.0002 in. The panel can be a metal foil. The
balloon can be pleated before use.
[0069] A method for making an inflatable device for use in a
biological body is disclosed. The method can include forming a
leak-proof member from solid film on a removable mandrel. The
forming can occur at a temperature below 100.degree. Celsius. the
forming occurs without solvation of the film. The method can
further include adhering the film to the mandrel, wherein adhering
comprises adhering with a water-soluble tacking adhesive. The
mandrel can be removed by dissolving the mandrel with water.
Forming can include pressure-forming. (i.e., hydroforming with a
fluid, even air).
[0070] The method can also include trimming the film. The thermoset
film can have one or more fibers or no fiber. The film can be
substantially anisotropically mechanically load-bearing. For
example, the load-bearing properties of the film can be
substantially unidirectional along the surface plane of the
film.
[0071] A method for making the device is disclosed that can include
adhering with a first bonding agent a first film to a mandrel,
forming the first film on about the first half of the mandrel,
bonding with a second bonding agent the first film to a second
film, forming the second film on about the second half of the
mandrel, and dissolving the mandrel. Dissolving can include
applying water to the mandrel. The first bonding agent can be
water-soluble. The mandrel can be made from a sugar, a plastic,
polylactic acid (PLA), polyvinylacetate, a water-soluble wax, or
combinations thereof.
[0072] A method for making the device is disclosed that can include
positioning a solid film on a mandrel and dissolving the mandrel
with the solid film on the mandrel. Dissolving can include
dissolving with water. The film can be water-tight. The film can be
configured as a flat piece of film before forming on the mandrel.
The film can have a square or rectangular shape before forming on
the mandrel.
[0073] Also disclosed is a method for making the device that can
include creating a first hole that transects a mandrel, passing a
fiber through the first hole, forming a layer of material on the
mandrel, attaching the layer to the fiber, and dissolving the
mandrel. Attaching can include attaching the fiber to the side of
the layer against the mandrel, attaching the fiber to the side of
the layer away from the mandrel, attaching the fiber to the inside
of the layer, or combinations thereof.
[0074] A method for making the device is disclosed that can include
applying fibers to a mandrel, applying an elastomeric resin to the
fibers and bonding the fibers to the mandrel. Applying the fibers
can include rotating the mandrel while feeding the length of the
fibers from a location off the mandrel. The fibers or layer
containing the fibers can be bonded to the mandrel or to an
adjacent layer to prevent the fibers from slipping against the
mandrel or adjacent layer. The mandrel can have an ovaloid
shape.
[0075] A method for making the device is disclosed that can include
applying a first layer of a material on a water-soluble mandrel and
forming a thermoset film on the first layer. The method can be
performed at a temperature from about 5 degrees Celsius to about 35
degrees Celsius, more narrowly from about 15.degree. C. to about
30.degree. C., for example at ambient or room temperature (e.g.,
about 18.degree. C. to about 25.5.degree. C.).
[0076] A method for making the device is disclosed that can include
applying a first layer of a material on a madrel, bonding with a
first bonding agent a first thermoset film to the first layer,
forming the first thermoset film on about the first half of the
first layer, bonding with a second bonding agent the first
thermoset film to a second thermoset film, forming the second
thermoset film on about the second half of the first layer, and
dissolving the mandrel.
[0077] A method for making the device is disclosed that can include
applying a first layer of a material on a mandrel, hydroforming an
MMA-resistant film on the first layer; and dissolving the mandrel
with water.
[0078] A method for using the device is disclosed that can include
inserting the inflatable device adjacent to a target site,
expanding the inflatable device to a pressure greater than about
350 kPa (51 psi), and delivering to the target site thermal energy
generated in the wall of the inflatable device. Delivering the
energy can include singeing or ablating tissue at the target
site.
[0079] The balloon can be attached to a deployment tool having a
deployment rod. The deployment rod can have a rod distal end. The
deployment rod can be positioned at least partially inside the
balloon when the balloon is in a deflated state. The deployment rod
can be slidably adjustable with respect to the location of the
proximal end of the balloon. The deployment rod can be in an
extended position when the balloon is in the substantially deflated
state. The deployment rod can be in a retracted position when the
balloon is in the substantially inflated state. The rod distal end
can be out of substantial contact with the balloon distal end when
the balloon is in the substantially inflated state.
[0080] The rod distal end can be in contact with the balloon distal
end when the balloon is in the substantially deflated state.
[0081] The deployment tool can have a fluid channel configured to
deliver fluid to the balloon. When the deployment rod is in an
extended position, the deployment rod can substantially obstruct
the fluid channel. When the when the deployment rod is in a
retracted position, the deployment rod can leave the fluid channel
substantially unobstructed by the deployment rod retracting the
deployment rod with respect to the balloon, wherein retracting
comprises substantially unobstructing fluid delivery through the
fluid channel. Further comprising delivering fluid to the balloon
after retracting the deployment rod.
[0082] The deployment rod can be positioned at least partially
inside the balloon when the balloon is in a deflated state. The
deployment rod can be fixed with respect to the location of the
proximal end of the balloon. The rod distal end can be
substantially separate (i.e., not in substantial or any contact)
with the balloon wall when the balloon is in the substantially
inflated state. The rod distal end can be atraumatic. The rod
distal end can have a curved surface facing the balloon distal end.
The deployment rod can be stiffer than the balloon when the balloon
is in a contracted state.
[0083] A method for using the device is disclosed that can include
inserting a working channel through the biological body, delivering
a first balloon through the working channel and positioning the
first balloon at the target site. After the delivering the first
balloon, the method can include delivering a second balloon through
the working channel and positioning the second balloon at the
target site while the first balloon is at the target site. The
method can also include delivering an unsupported (i.e., in free
air or about standard atmospheric pressure) pressure of greater
than about 1400 kPa (200 psi) to the first and/or second balloon.
The working channel can have an inner diameter less than about 5
mm. The working channel can have a distal port. The distal port can
be positioned adjacent to, or at, the target site, such as the
inside of a vertebral body. The second balloon can be inflated
after or concurrent with inflating the first balloon.
[0084] The working channel can have an inner diameter less than
about 5 mm. The first and second balloons can be attached to
separate first and second deployment systems, respectively,
enabling independent orientation and/or translation of the first
balloon from the second balloon, or the first and second balloons
can be attached to a single integral joint deployment system.
[0085] An inflatable device system is disclosed that can include a
curved guide block, a drill, a trocar, a first balloon, a steering
mechanism, and combinations thereof. A method for using the system
can include positioning a guide block outside of the biological
body and delivering a drill through the guide block. The method can
include delivering the device through the guide block and into the
biological body.
[0086] An inflatable device system is disclosed that can have a
balloon, a reservoir, a fluid in the reservoir; and a sealed
sterile package. The balloon, the reservoir and the fluid can be in
the sealed sterile package.
[0087] An inflatable device kit is disclosed that can have a
balloon having a fully inflated state having an inflated volume, a
fluid channel having a fluid channel volume, a sealed reservoir,
and a fluid in the reservoir. The fluid in the reservoir can have a
fluid volume. The fluid volume can be within 10% of the sum of the
inflated volume and the fluid channel volume.
[0088] A deployment tool for use with the inflatable device is
disclosed that can have a fluid first channel having an incoming
port. The fluid first channel can have a luer connector at the
incoming port, a check valve and a swabbable valve. The swabbable
valve can be adjacent to the luer connector. The check valve can be
downstream from the luer connector.
[0089] An assembly for use in percutaneously treating a bone
predisposed to fracture or to collapse, or that is fractured or
collapsed, is disclosed. The assembly can have a cannula, a
balloon, a catheter and a driving rod. The balloon can be
insertable through the cannula into bone. The balloon can have a
deflated condition which has a size for passage through the cannula
for insertion into bone. The balloon can be inflated to a
predetermined shape and size sufficient for compressing at least a
portion of inner cancellous bone so as to form a cavity therein.
The balloon can be restrained in the inflated condition to create
said predetermined shape and size by having a wall that is thicker
in selected portions than it is in other portions and/or by an
internal restraint provided in or on the balloon wall and/or by an
external restraint in or on the balloon wall. The outer diameter of
the catheter can be smaller than the inner diameter of the cannula.
The cannula can be adapted to not drive the deflated balloon
through the cannula into the bone. The driving rod can releasably
attach to the device. The driving rod can be adapted to drive the
balloon through the cannula into the bone.
[0090] The catheter can have an elastomer and a fiber. The driving
rod can have a shaft and a clasp at the distal end of the
shaft.
[0091] A method for using the device is disclosed that includes
inserting a balloon into the target site, inflating the balloon and
injecting a load of bone cement into the target site. The load of
bone cement can cure while in contact with the balloon. The balloon
does not substantially degrade from contact with the load of bone
cement. The balloon can have a fiber made from a substantially
different material than the remainder of the balloon. Inserting can
include inserting with a detachable driving rod. The method can
include creating a void at the target site.
[0092] The balloon can be non-compliantly expanded. For example,
the wall of the balloon can expand no more than about 2% to about
3% strain between the deflated state to the inflated state.
[0093] The device can be used to perform valvulopasty,
annuloplasty, kyphoplasty, sinuplasty or angioplasty procedures.
The device can be used to minimally invasively deliver and expand a
vascular stent, graft or heart valve. The device can be used to
expand constrictions in the urethra. The device can be used to
dilate CTOs. The device can be used to temporarily or permanently
occlude vessels, for example to isolate a space within a vessel to
locally deliver drugs or to intentionally cause necrosis. The
device can be used to deliver therapeutic and/or diagnostic drugs.
The device can be used to deliver energy to warm, singe or ablate
adjacent tissue. The device can be used as a radiopaque or
echogenic marker. The device can be used during a balloon
enteroscopy procedure or during colonoscopy. The device can be used
to cut, tear, or otherwise rip tissue. The device can be implanted
and inflated to create an anatomical feature, such as a breast
implant.
BRIEF DESCRIPTION OF THE FIGURES
[0094] FIG. 1 illustrates a variation of the device.
[0095] FIG. 2 illustrates a variation of cross section A-A of FIG.
1.
[0096] FIGS. 3A through 3C are cross-sectional views of a length of
variations of the device.
[0097] FIG. 4A illustrates a variation of the device.
[0098] FIGS. 4B and 4C are variations of cross-section C-C of FIG.
4A.
[0099] FIG. 5A illustrates a variation of the device.
[0100] FIGS. 5B and 5C are variations of cross-section D-D of FIG.
5A.
[0101] FIG. 6A illustrates a variation of the device.
[0102] FIG. 6B is a variation of cross section E-E of the device of
FIG. 6A.
[0103] FIG. 6C is a variation of cross section F-F of the device of
FIG. 6A.
[0104] FIG. 6D is a variation of cross section G-G of the device of
FIG. 6A.
[0105] FIGS. 7 and 8 illustrate variations of the device.
[0106] FIG. 9A illustrates a variation of the device in a deflated
state.
[0107] FIG. 9B illustrates a variation of the device in an inflated
state.
[0108] FIGS. 10A through 10D illustrate variations of the
device.
[0109] FIGS. 11A and 11B illustrate partially see-through
variations of the device.
[0110] FIGS. 11C through 11F are variations of cross-section H-H of
FIG. 11A.
[0111] FIGS. 12 through 18 illustrate variations of the device.
[0112] FIG. 19A illustrates a variation of the device.
[0113] FIG. 19B is a variation of cross section i-i of FIG.
19A.
[0114] FIG. 20A illustrates a variation of the device.
[0115] FIG. 20B is a variation of cross section JJ of FIG. 19A.
[0116] FIGS. 21A and 21B are top and bottom perspective views,
respectively, of a variation of the device.
[0117] FIG. 22A illustrates a variation of the device.
[0118] FIG. 22B is a variation of cross-section K-K of FIG.
22A.
[0119] FIG. 23A illustrates a variation of the device.
[0120] FIGS. 23B and 23C are variations of cross-section L-L of
FIG. 23A.
[0121] FIG. 24A illustrates a variation of the device.
[0122] FIG. 24B is a variation of cross-section M-M of FIG.
24A.
[0123] FIGS. 25 through 28 are cross-sectional views of variations
of the device.
[0124] FIG. 29A illustrates a variation of the device.
[0125] FIG. 29B is a variation of cross-section N-N of FIG.
29A.
[0126] FIGS. 30A, 31A, 32A, 33A and 34A illustrate variations of
the device.
[0127] FIGS. 30B; 30C; 31B; 32B; 33B; 34B and 34C are variations of
cross-sectional views P-P through T-T respectively, of FIGS. 30A,
31A, 32A, 33A and 34A, respectively.
[0128] FIG. 35A illustrates a variation of the device.
[0129] FIG. 35B is a variation of cross-section U-U of FIG.
35A.
[0130] FIG. 36A illustrates a variation of the device.
[0131] FIG. 36B is a variation of cross-section V-V of FIG.
36A.
[0132] FIG. 37A illustrates a variation of the device.
[0133] FIG. 37B is a variation of cross-section W-W of FIG.
37A.
[0134] FIG. 38A illustrates a variation of the device.
[0135] FIGS. 38B, 38C and 38D are variations of cross-section X-X
and Y-Y of FIG. 38A.
[0136] FIG. 39A illustrates a variation of the device.
[0137] FIGS. 39B, 39C are variations of cross-section Z-Z and AA-AA
respectively of FIG. 39A.
[0138] FIG. 40 illustrates a variation of the device.
[0139] FIGS. 41A and 41B illustrate a variation of the device in
deflated and inflated configurations, respectively.
[0140] FIGS. 42A-42E are partial see-through views of variations of
the device.
[0141] FIG. 43 illustrates a variation of an elongated element or
strip.
[0142] FIG. 44 illustrates a variation of an element of the
device.
[0143] FIG. 45 illustrates a variation of the device.
[0144] FIGS. 46A through 46O are sectional views through variations
of cross section BB-BB of FIG. 1.
[0145] FIGS. 47 through 49 are tables listing film materials,
reinforcement materials, and adhesive and matrix materials,
respectively.
[0146] FIG. 50 illustrates a variation of a tool for manufacturing
a variation of the inflatable device.
[0147] FIG. 51 is a variation of cross-sectional view CC-CC of FIG.
50.
[0148] FIG. 52 is a chart of material characteristics for
variations of mandrel materials.
[0149] FIGS. 53 through 58 illustrate a variation of a method for
manufacturing the device.
[0150] FIGS. 59A through 59H illustrate a method of making fiber
tape.
[0151] FIGS. 60 through 67 illustrate a variation of a method for
manufacturing the device.
[0152] FIG. 68 illustrates a variation of a method for removing the
mandrel.
[0153] FIG. 69 illustrates a variation of the device in an inflated
state before being pleated.
[0154] FIG. 70 illustrates a method of adding pleats or folds to a
variation of the device.
[0155] FIG. 71 illustrates a variation of the device in a deflated,
pleated state.
[0156] FIG. 72 illustrates a portion of a method that may be used
to produce unidirectional fiber tape.
[0157] FIG. 73 illustrates a portion of a method that may be used
to produce unidirectional fiber tape.
[0158] FIGS. 74 through 77 illustrate variations of arrangements of
unidirectional fiber tape.
[0159] FIG. 78 illustrates a variation of a method for making a
laminate.
[0160] FIG. 79 is a process flow chart of a variation of a process
for making a laminate.
[0161] FIG. 80 is a graph illustrating a variation of temperature
and pressure verse time graph for a method for compacting or curing
or melting that can be used with a fiber tape.
[0162] FIG. 81A-81D illustrates a variation of the mandrel.
[0163] FIG. 82A illustrates a variation of a manufacturing
tool.
[0164] FIG. 82B is a variation of cross-sectional view GG-GG of
FIG. 82A.
[0165] FIG. 83 illustrates a variation of the fiber during a
variation of a method for manufacturing the device.
[0166] FIG. 84 is a variation of cross-sectional view GG-GG of FIG.
82A.
[0167] FIG. 85 illustrates a variation of the fiber during a
variation of a method for manufacturing the device.
[0168] FIG. 86 illustrates a variation of a method for
manufacturing the device.
[0169] FIG. 87 illustrates a variation of the fiber during a
variation of a method for manufacturing the device.
[0170] FIG. 88 illustrates a variation of a method for
manufacturing the device.
[0171] FIGS. 89 through 91D illustrate variations of a method for
manufacture of the device.
[0172] FIGS. 92 through 94 illustrate variations of methods for
manufacturing the device.
[0173] FIGS. 95 through 100 illustrate variations of laminate
sheets.
[0174] FIGS. 101 through 107 illustrate a method for manufacturing
the device.
[0175] FIG. 108A illustrates a variation of a tool for
manufacturing a variation of the inflatable device.
[0176] FIG. 108B is a variation of cross-sectional view II of FIG.
108A
[0177] FIGS. 109 through 115 illustrate a variation of a method for
manufacturing the device.
[0178] FIGS. 116 through 119 illustrate a method for manufacturing
the device.
[0179] FIG. 120 illustrates a variation of a layer.
[0180] FIGS. 121 and 122 illustrate variations of elongated
elements.
[0181] FIGS. 123 and 124 illustrate variations of three overlayed
elongated elements.
[0182] FIGS. 125 though 127 illustrate variations of methods for
manufacturing the device.
[0183] FIG. 128A illustrates a variation of a manufacturing
tool.
[0184] FIG. 128B is a variation of cross-sectional view LL-LL of
FIG. 128A.
[0185] FIG. 128C is a close-up view MM-MM of FIG. 128B.
[0186] FIG. 129 is a partial see-through view of a sagittal view of
a spine in a patient.
[0187] FIG. 130 is a partial see-through coronal view of a
vertebra.
[0188] FIGS. 131, 134, 135, 137, 138, 139 and 140 are coronal
cross-sectional views of a variation of a method of using a
variation of the device in a vertebra.
[0189] FIG. 132 illustrates a cross-section of a variation of the
balloon wall.
[0190] FIG. 133 illustrates a cross-section of a variation of the
balloon contracted inside of the delivery tube.
[0191] FIG. 136 is a graph of compliance of the variation of the
balloon compared with a typical compliant balloon.
[0192] FIGS. 141A through 141i are coronal cross-sectional views of
a variation of a method of using a variation of the device in a
vertebra.
[0193] FIGS. 142A through 142F are coronal cross-sectional views of
a variation of a method of using a variation of the device in a
vertebra.
[0194] FIGS. 143A through 143i are coronal cross-sectional views of
a variation of a method of using a variation of the device in a
vertebra.
[0195] FIG. 144 illustrates a variation of the delivery guide
block.
[0196] FIGS. 145 and 146 illustrate a variation of a method for
using the delivery guide block.
[0197] FIGS. 147 through 149 illustrate variations of a deployment
tool with the device.
[0198] FIG. 150A through 150C illustrate a variation of a method
for using the device and the deployment tool.
[0199] FIG. 151A illustrates a variation of the deployment
tool.
[0200] FIG. 151B illustrates the proximal end of the variation of
the deployment tool during use.
[0201] FIG. 151C is a variation of cross-sectional view PP-PP of
FIG. 151A shown in a closed configuration.
[0202] FIG. 151D is a variation of cross-sectional view PP-PP of
FIG. 151A shown in an opened configuration.
[0203] FIG. 152A illustrates a variation of the deployment
tool.
[0204] FIG. 152B illustrates the proximal end of the variation of
the deployment tool during use.
[0205] FIG. 152C is a variation of cross-sectional view QQ-QQ of
FIG. 152A shown in a closed configuration.
[0206] FIG. 152D is a variation of cross-sectional view QQ-QQ of
FIG. 152A shown in an opened configuration.
[0207] FIG. 153 is a variation of cross-sectional view A-A of FIG.
1
[0208] FIG. 154A illustrates a variation of the device with a
component for inserting the device into the body.
[0209] FIG. 154B is a variation of cross-sectional view RR-RR of
FIG. 154A.
[0210] FIG. 155A illustrates a variation of the device with a
component for inserting the device into the body.
[0211] FIG. 155B is a variation of cross-sectional view SS-SS of
FIG. 155B
[0212] FIG. 156 illustrates a variation of a system for using the
device.
[0213] FIG. 157 illustrates a variation of the deployment rod.
[0214] FIGS. 158 and 159 illustrate a variation of a method for
using the device.
[0215] FIG. 160 is a variation of cross-sectional view TT-TT of
FIG. 159.
[0216] FIG. 161 is a variation of close-up of FIG. 160
[0217] FIG. 162 illustrates a variation of a method for using the
device.
[0218] FIGS. 163A, 164A, 165A and 166A illustrate variations of the
device.
[0219] FIGS. 163B, 164B, 165B and 166b illustrate variations of the
distal ends of deployment or driving rods configured to interface
with the devices of FIGS. 163A, 164A, 165A and 166A
respectively.
[0220] FIGS. 167, 168 and 169 illustrate sectional views of
variations of methods for using a deployment or driving rod with
the device.
[0221] FIG. 170 illustrates a variation of a method for using a
deployment or driving rod with the device.
[0222] FIG. 171A illustrates a variation of the shaft of the
deployment rod.
[0223] FIGS. 171B through 171i are variations of cross-section of
FIG. 171A.
[0224] FIG. 172A illustrates a variation of a method for using a
deployment or driving rod with the device.
[0225] FIG. 172B is a variation of cross-sectional view UU-UU of
FIG. 172A.
[0226] FIGS. 173A and 173B are cross sections of variations of
methods of deployment.
[0227] FIG. 174A is a variation of a tool for inflating the
inflatable device.
[0228] FIG. 174B is a variation of a sectional view of FIG.
174A.
[0229] FIGS. 175 through 177 illustrate variations of a kit
including the device.
[0230] FIGS. 178 through 179F illustrate a variation of a method
for valvuloplasty.
[0231] FIGS. 180A through 180C illustrate a variation of a method
for angioplasty.
DETAILED DESCRIPTION
[0232] FIG. 1 illustrates that a medical inflatable device 2 can
have a balloon 20 and a hollow shaft 2000. An inflation system
(shown herein) can be attached to the hollow shaft to deliver a
fluid pressure through the hollow shaft and to the balloon. The
balloon 20 can be resilient (i.e., elastic) or non-compliant (i.e.,
inelastic). The balloon 20 can have a balloon longitudinal axis 26.
The balloon 20 can have a balloon wall 22. The balloon wall 22 can
define a cavity having a balloon volume 24.
[0233] FIG. 2 illustrates that the balloon 20 can have balloon
length 28. The balloon 20 can have a balloon proximal stem 30
having a balloon proximal stem length 32. The proximal stem length
32 can be from about 5 mm (0.2 in.) to about 15 mm (0.6 in.). The
balloon can have a balloon proximal taper 34 having a balloon
proximal taper length 36. The balloon proximal taper length 36 can
be from about 0 mm (0 in.) to about 20 mm (0.8 in.), more narrowly
from about 0 mm (0 in.) to about 15 mm (0.6 in.), yet more narrowly
from about 5 mm (0.2 in.) to about 10 mm (0.4 in.) The balloon 20
can have a constant-diameter section 38 having a constant-diameter
section length 40. The constant-diameter section length 40 can be
from about 0 mm (0 in.) to about 15 mm (0.6 in.), more narrowly
from about 0 mm (0 in.) to about 10 mm (0.4 in.). The balloon 20
can have a balloon distal taper 42 at the terminal distal end 68 or
tip of the balloon 20. The distal taper 42 can have a distal taper
length 44. The distal taper length 44 can be from about 0 mm (0
in.) to about 14 mm (0.55 in.), more narrowly from about 2 mm to
about 9 mm.
[0234] The proximal and/or distal tapers 34 and/or 42 can have
concave, convex and/or s-curves. For example, the proximal and/or
distal tapers 34 and/or 42 can have continuously varying angles
with respect to the balloon longitudinal axis 26.
[0235] The balloon 20 can have a wall thickness 46. The wall
thickness 46 can be less than about 25 .mu.m (0.98 mil). The wall
thickness 46 can be from about 25 .mu.m (0.98 mil) to about 250
.mu.m (9.8 mil), more narrowly from about 50 .mu.m (2 mil) to about
150 .mu.m (5.9 mil), for example about 75 .mu.m (3.0 mil) or about
100 .mu.m (4 mil).
[0236] The balloon can have a balloon inner diameter 48 and a
balloon outer diameter 50. The balloon outer diameter 50 can be
measured perpendicular to the balloon longitudinal axis 26 at the
widest point along the length of the balloon 20. The balloon outer
diameter 50 can be from about 2 mm (0.08 in.) to about 50 mm (in.)
for example about 17 mm (0.67 in.), 23 mm (0.91 in.), 3 mm (0.12
in.), or 6 mm (0.24 in.).
[0237] The balloon can have a radius (i.e., half the diameter), for
example about 8.5 mm, and a distal taper length, for example about
8.5 mm. The ratio of the distal end length to the radius can be
from about 2:1 to about 0:1, more preferably about 1:1 to about
0.25:1.
[0238] The balloon can have an unsupported burst pressure. The
unsupported burst pressure is the pressure at which the balloon
ruptures when inflated in free air without any external constraint
on the walls at about 1 atm external pressure and about 20.degree.
C. temperature. The unsupported burst pressure can be greater than
about 150 psi. For example, the unsupported burst pressure can be
from about 1,400 kPa (200 psi) to about 10,000 MPa (1,500 psi).
More narrowly, the burst pressure can be from about 3,500 kPa (500
psi) to about 6,000 kPa (900 psi). For example, the burst pressure
can be about 3,500 kPa (500 psi), about 5,200 kPa (750 psi), about
7,000 (1,000 psi), about 10,000 kPa (1,500 psi), or higher than
10,000 kPa (1500 psi).
[0239] The balloon 20 can be non-compliant or inelastic. The
balloon can have a failure strain of less than 0.30, more narrowly
less than 0.20, more narrowly less than 0.10, yet more narrowly
less than 0.05. A non-compliant balloon can have a failure strain
of less than 0.30.
[0240] The failure strain of the balloon is the difference between
the balloon outer diameter when the balloon is inflated to 100% of
the burst pressure and the balloon outer diameter when the balloon
is inflated to 5% of the burst pressure (i.e., to expand from a
deflated state without stretching the wall material) divided by the
100% pressure diameter.
[0241] For example, the burst pressure of the balloon can be
greater than about 3,500 kPa (500 psi) and have an outer diameter
of about 17 mm and a wall thickness of less than about 100 .mu.m
with a failure strain of less than about 0.10, for example less
than about 0.05.
[0242] The reinforced balloon wall may have a high tear strength as
compared to traditional polymers. Tear strength can correlate to
puncture strength and toughness. For example, in a Mod Mil-C-21189
10.2.4 tear test, a specimen is created. That specimen has a width,
a height, and thickness. A slit is made in the sample parallel to
the width, mid-way along its height. The slit is then pulled to
initiate tear at the corners of the slit. The Mod Mil-C-21189
10.2.4 tear test gives resultant data in tensile pounds force
(lbf). For the test to be meaningful as a comparison between two
material samples, it should be done on a thickness-comparable
basis. A nylon 12 balloon material at about 0.0055 in. thickness
failed the test at a mean tensile load of 25 lbf. The balloon wall
22 of about 0005 in. failed at a mean tensile value of 134 lbf.
[0243] In an ASTM D-3039 tensile test, a nylon 12 material at
0.0055 in. thickness, failed at a mean tensile load of 22 lbf. The
balloon wall 22 of about 0.005 in. failed at a mean tensile value
of 222 lbf.
[0244] The balloon wall 22 can have one or more layers 72. The
balloon 20 can have a leak-proof bladder 52. The bladder 52 can be
fluid-tight, such as an air-tight, or saline tight, or a fluid
porous bladder. The bladder 52 can be made of a urethane, a nylon,
any material listed infra, or combinations thereof. The bladder 52
can be made from the radial inner-most layer 72b of the balloon
wall 22.
[0245] The bladder 52 can be fixedly or removably attached to the
hollow shaft 2000, for example at the inside and/or outside
diameter of hollow shaft 2000. The hollow shaft 2000 can be a
flexible or rigid catheter. The hollow shaft 2000 can deliver
pressurized fluid to the balloon volume 24.
[0246] The balloon 20 can have one or more balloon fluid ports 56.
The hollow shaft 2000 can have a hollow shaft distal port 54. One
of the balloon fluid ports 56 can attach to the hollow shaft distal
port 54. The balloon 20 (as shown in FIGS. 29A and 29B) can have a
balloon fluid first port 56a at a proximal end of the balloon 20
and a balloon fluid second port 56b at a distal end of the balloon
20. The fluid first port 56a can be in fluid communication with the
balloon fluid second port 56b via a through lumen and/or the
balloon volume 24. The balloon 20 can have a single balloon fluid
port 56, two, three or more balloon fluid ports 56. The balloon 20
can have no through lumen. For example, the balloon 20 can have no
longitudinal through-lumen extending through the proximal terminal
end 70 and through the distal terminal end 68.
[0247] FIGS. 3A, 3B and 3C show cross sections of a balloon wall
22. FIG. 3A illustrates that a balloon 20 can have a constant or
varying wall thicknesses 46 along the length of the balloon 20. A
wall proximal stem thickness 46a can be substantially equal to a
wall constant diameter section thickness 46c and the wall proximal
taper thickness 46b.
[0248] FIG. 3B illustrates that the wall constant diameter section
thickness 46c can be substantially greater than the wall proximal
stem thickness 46a. The wall proximal taper thickness 46b can be
less than the wall constant diameter section thickness 46c and
greater than the wall proximal stem thickness 46a.
[0249] FIG. 3C illustrates that the wall proximal stem thickness
46a can substantially greater than the wall constant diameter
section thickness 46c. The wall proximal taper thickness 46b can be
less than the wall proximal stem thickness 46a and greater than the
wall constant diameter section thickness 46c.
[0250] FIG. 4A illustrates that the balloon 20 can have a single
balloon external seam 66a. The seam can extend partially,
completely, or not at all through the depth of the wall thickness
46. The balloon external seam 66a can be a longitudinal seam. The
balloon external seam 66a can extend from a first lateral side of
the balloon 20 at the proximal terminal end 70 of the balloon 20,
along the first lateral side of the balloon to the balloon distal
terminal end 68. The balloon external seam 66a can wrap around the
balloon distal terminal end 68a, extending around the distal end of
the balloon 20 and returning on the second lateral side of the
balloon 20.
[0251] The outer layer 72a of the balloon wall 22 can have an outer
layer first panel 76a and an outer layer second panel 76b. The
outer layer first panel 76a can cover from about 90.degree. to
about 270.degree. of the balloon, as measured along the balloon
longitudinal axis 26, for example about 185.degree. of the balloon
20. The outer layer second panel 76b can cover from about
90.degree. to about 270.degree., as measured along the balloon
longitudinal axis 26, for example about 185.degree..
[0252] FIG. 4B illustrates that the balloon external seam 66a can
be an overlayed seam or lap joint. The balloon external seam 66a
can be flush against the side (i.e., having a substantially
constant radius with respect to the balloon longitudinal axis 26)
of the outer layer first panel 76a or outer layer second panel 76b.
The outer layer first panel 76a can be radially outside of the
outer layer second panel 76b where the outer layer first panel 76a
overlaps the layer second panel 76b. The outer panels 76 may have
an overlap length. The overlap length can be from about 0 mm (0
in.) to about 3 mm (0.1 in.), more narrowly from about 1 mm (0.04
in.) to about 2 mm (0.08 in.). The outer layer first panel 76a can
be bonded or adhered (e.g., with epoxy or other adhesive) to the
outer layer second panel 76b. The adhesive can be an epoxy.
[0253] The inner layer 72b can have a balloon inner seam 66b. The
balloon inner seam 66b can join an inner layer first panel 74a and
an inner layer second panel 74b. The inner seam 66b can have a
similar structure to those described here for the balloon outer
seam 66a,
[0254] FIG. 4C illustrates that the outer layer first panel 76a can
be fused, solvated to, glued, adhered to, welded to, or a
combination thereof, with the outer layer second panel 76b at the
outer seam 66a.
[0255] FIG. 5A illustrates that the balloon external seam 66a can
be a flange joint. The layer first panel can have a seam first
flange 80a around the perimeter of the outer layer first panel 76a.
The outer layer second panel 76b can have a seam second flange 80b
around the perimeter of the layer second panel. The seam first
flange can attach to the seam second flange at the balloon external
seam. The flange seam can extend radially away from the balloon
longitudinal axis. The balloon external seam can be reinforced. The
balloon external seam can be used to cut tissue during use in a
biological target site.
[0256] FIG. 5B illustrates that the seam first flange can be bonded
or adhered to the seam second flange in the flange joint. FIG. 5C
illustrates that the layer first panel can be fused, solvated to,
glued, adhered to, welded to, or a combination thereof, with the
layer second panel in the flange joint.
[0257] FIG. 6A illustrates that the balloon external seam 66a can
be a lateral or latitudinal seam. The balloon external seam can be
in a plane perpendicular or substantially to the balloon
longitudinal axis. The balloon can have one or more balloon
external seams.
[0258] The outer layer first panel 76a can be at the distal end of
the balloon 20. The outer layer second panel 76b can be at the
proximal end of the balloon 20. The layer second panel can overlay
the layer first panel at the balloon external seam.
[0259] FIG. 6B illustrates that the outer layer first panel can
overlay the outer layer second panel at the balloon external seam
66a.
[0260] FIG. 6C illustrates that the balloon wall at a first length
along the balloon can have a first layer and a second layer. The
first layer can be a radially inner layer 72b, as measured from the
balloon longitudinal axis. The second layer can be a radially outer
layer 72a. Any of the layers 72 can be a laminate of fiber and
resin. The resin can be an adhesive. The fiber and resin laminate
can be a matrix of the fiber in the resin.
[0261] FIG. 6D illustrates that the balloon wall at a second length
along the balloon can have first, second and third layers. The
second layer can be a first middle layer 72c between the inner and
outer layers. Any combination of the layers can be leak-proof,
reinforced with one or more fibers, resistant and releasable from
MMA, or combinations thereof. For example, the first layer can be
leak-proof and form the bladder. The second layer can be reinforced
with a fiber. The third layer can be MMA-resistant and/or
MMA-releasing.
[0262] An MMA-resistant material can substantially maintain
material strength and thickness when exposed to MMA bone cement in
any stage of the MMA bone cement from mixing to curing. An
MMA-releasable material can form no substantial bond with MMA.
[0263] FIG. 7 illustrates that the balloon external seam can be
along the balloon at the proximal taper. The balloon external seams
can be in the constant diameter section, the distal taper, the
proximal taper, the proximal stem, or combinations thereof.
[0264] FIG. 8 illustrates that balloon external seam 66b can lie in
a plane at a non-perpendicular angle to the balloon longitudinal
axis 26. The plane in which the balloon external seam lies can form
a seam angle 82 with the balloon longitudinal axis. The seam angle
82 can be from about 0.degree. (i.e., a longitudinal seam) to about
90.degree. (i.e., a latitudinal seam). More narrowly, the seam
angle 82 can be from about 30.degree. to about 60.degree.. For
example, the seam angle 82 can be about 0.degree., about
30.degree., about 45.degree., about 60.degree., or about
90.degree..
[0265] FIG. 9A illustrates that the balloon 10 can be pleated to
form flutes 84, for example four, five or six flutes 84, such as
first flute 84a, second flute 84b. The flutes 84 can be made from
accordion pleats, box pleats, cartridge pleats, fluted pleats,
honeycomb pleats, knife pleats, rolled pleats, or combinations
thereof. The pleating can be heat and/or pressure formed and/or the
reinforcement fibers and/or panels can be oriented to form the
flutes 84. The balloon 20 can be in a deflated configuration when
the flutes 84 are shown.
[0266] FIG. 9B illustrates that the balloon 20 in an inflated
configuration can push the pleated flutes out to form a
substantially smooth outer surface. The balloon 20 can have
reinforcement fibers 86. First or longitudinal reinforcement fibers
86a can be parallel with the balloon longitudinal axis 26. Second
or latitudinal reinforcement fibers 86b can be perpendicular to the
balloon longitudinal axis 26.
[0267] The proximal end of the balloon can be bonded, glued, welded
to, adhered, clamped, fused, or combinations thereof to the distal
end of the hollow shaft. For example, a balloon cuff can apply a
tension force between the proximal terminal end of the balloon and
the distal end of the hollow shaft
[0268] FIG. 10A illustrates that the balloon can have a blunt
distal terminal end. The distal terminal end can be rounded. The
distal taper can have a taper angle 90a measured from a
perpendicular off the balloon longitudinal axis. The taper angle
can be from about 0.degree. to about 80.degree., more narrowly from
about 2.degree. to about 45.degree., yet more narrowly from about
5.degree. to about 30.degree., for example about 0.degree.,
10.degree. or 15.degree..
[0269] FIG. 10B illustrates that the distal terminal end can be
substantially flat. The taper angle of the balloon in FIG. 8B is
lower than the taper angle of the balloon in FIG. 8A.
[0270] FIG. 10C illustrates that the distal terminal end can have
facets. The facets can be angularly arranged around the balloon
longitudinal axis.
[0271] FIG. 10D illustrates that the balloon distal terminal end
can be configured to evert into the volume of the balloon. For
example, the balloon distal terminal end can be hemi-toroidal, for
example with an inner diameter of about 0 mm (0 in.).
[0272] FIG. 11A illustrates that the balloon can have a first
and/or second steering wires 94a and/or 94b. The first and second
steering wires 94a and 94b can be evenly (about 180.degree. apart)
or unevenly (e.g., about 90.degree. apart) spaced from each other
with respect to the balloon longitudinal axis. The balloon can have
third and/or fourth steering wires (not shown) evenly spaced along
the balloon wall between the first and second steering wires.
[0273] The first steering wire 94a can be fixed to the balloon wall
at a first wire terminal 96a. The second steering wire can be fixed
to the balloon wall at a second wire terminal 96b. The wire
terminals 96 can be located in the constant diameter section of the
balloon, the proximal taper, the distal taper, or a combination
thereof. The first wire terminal 96a can be located at the same or
a different length along the balloon as the second wire terminal
96b.
[0274] The steering wires 96 can be slidably translatable with
respect to the balloon 20, for example except at the terminal ends.
Forces can be delivered to the steering wires 96 to angularly
rotate or deflect the balloon 20 with respect to an attached
member, such as a deployment rod or the hollow shaft.
[0275] FIG. 11B illustrates that the balloon 20 can have a steering
collar 98. The steering collar 98 can be rigid. The steering collar
98 can be a metal or plastic member embedded within or attached to
the inside or outside of the balloon wall. The steering collar 98
can be a reinforced area of the balloon wall, for example,
reinforced with additional reinforcement fibers. The wire terminals
can be located on the steering collar. The steering wires can be
fixed to the steering collar. The first steering wire can be fixed
to a first steering collar. The second steering wire can be fixed
to a second steering collar.
[0276] The steering collar can be located in the constant diameter
section of the balloon, the proximal taper, the distal taper, or a
combination thereof, for example if the balloon has the two or more
steering collars and/or the steering collar is at a
non-perpendicular angle to the balloon longitudinal axis.
[0277] FIG. 11C illustrates that the balloon can have a steering
sheath 100. The steering wire 94 can slide within the steering
sheath. The steering sheath 100 can be radially inside, radially
outside, or embedded within (as shown) the balloon wall 22. The
steering sheath 100 can be made from a low friction material and/or
be coated with a low friction material, such as PTFE or Teflon.
[0278] FIG. 11D illustrates that the steering wire 94 can be
located in the balloon wall 22, for example between the inner and
outer layers 72b and 72a of the balloon wall 22. The balloon wall
22 can have no steering sheath or the steering sheath can end at a
length before the wire terminal 98.
[0279] FIG. 11E illustrates that the steering wire can be on the
outside of the balloon wall, opposite of the balloon volume. FIG.
11F illustrates that the steering wire can be on the inside of the
balloon wall, within the balloon volume.
[0280] FIG. 12 illustrates that the proximal stem, proximal taper,
constant diameter section, distal taper, or combinations thereof
can be curved. The balloon longitudinal axis can be straight or
have a balloon radius of curvature 102. The balloon radius of
curvature 102 can be from about 2 to about 50 mm, for example about
5 mm, about 8 mm, or about 30 mm.
[0281] FIG. 13 illustrates that the balloon can have a C-shaped
configuration. For example, the balloon radius of curvature can be
from about 5 mm to about 40 mm for example about 15 mm
[0282] FIG. 14 illustrates that the balloon can bifurcate into a
first balloon branch 106a and a second balloon branch 106b. The
first balloon branch 106a, second balloon branch 106b and proximal
stem 30 can be coplanar (as shown) or not coplanar. Third, fourth
or more balloon branches can extend from the proximal stem. The
balloon branches 106 can be in fluid communication with the
proximal stem 30 and other balloon branches 106. The balloon
branches 106 can be inflated and deflated concurrently. The balloon
branches 106 can be in fluid isolation from the other balloon
branches 106. The balloon branches 106 can be inflated and deflated
subsequent to the other balloon branches 106.
[0283] The proximal stem 30 can have a proximal stem longitudinal
axis 110. The balloon first branch 106a and the balloon second
branch 106b can be evenly separated (by about) 180.degree. or
unevenly separated (e.g., by about 90.degree.) with respect to the
proximal stem axis 110.
[0284] The balloon first branch 106a can have a first branch
longitudinal axis 108a. The first branch longitudinal axis 108a can
be straight or curved. The balloon second branch 106b can have a
second branch longitudinal axis 108b. The second branch
longitudinal axis 108b can be straight or curved. The balloon first
branch 106a can have the same, the symmetric, or a different shape
as the balloon second branch 106b. The balloon branches 106 can
have symmetric c-shapes (as shown).
[0285] The balloon first branch 106a can have a balloon first
distal terminal end 68a. The balloon second branch 106b can have a
balloon second distal terminal end 68b. The balloon 20 can have a
terminal end gap 104 between the first distal terminal end 68a and
the second distal terminal end 68b.
[0286] The balloon wall can have a pressure input port in fluid
communication with a pressure channel embedded in or attached to
the outside or inside of the wall of the balloon. The port can be
for inflating the balloon. The pressure can be delivered to the
inner lumen 154a. The pressure can be and is conveyed with
water.
[0287] The balloon wall can have a bone cement input port 114a. The
bone cement input port 114a can be in fluid communication with a
bone cement channel embedded in or attached to the outside or
inside of the balloon wall 22, or as an outer lumen 154b (shown
supra) within the balloon 20.
[0288] The balloon first and/or second branch can have one or more
bone cement output ports 114b. The bone cement channel can be in
fluid communication with the bone cement output ports 114b. The
bone cement output ports can open to a contained area 112 defined
by the first balloon branch and the second balloon branch. The bone
cement output ports can open away from the contained area 112. The
bone cement can be a bone cement or one or more liquid, gel or
solid bone fillers with no cement properties.
[0289] FIG. 15 illustrates that the balloon can have a
substantially toroidal configuration. For example, the balloon can
have no balloon terminal distal end. The proximal stem can attach
to a toroidal constant diameter section. The toroid can define a
circular contained area 112.
[0290] FIG. 16 illustrates that the balloon can have a
substantially cylindrical configuration. The balloon can have a
balloon top 116, balloon bottom 118 and a balloon pressure input
port 56. During inflation, the balloon 20 can expand in the
vertical direction. The balloon 20 can be folded in a contracted or
deflated configuration. The ratio of balloon height 120 to balloon
width 120 can be 1:3. For example, the balloon can form a disc. The
ratio of balloon height 120 to balloon width 120 can be 1:1, for
example the balloon can expand significantly in height during
expansion. The balloon top 116 can be parallel to the balloon
bottom 118. The balloon top 116 can be flat or tilted at about
10.degree., about 20.degree., or about 30.degree. relative to the
balloon bottom 118.
[0291] FIG. 17 illustrates that the balloon 20 can have balloon
first, second, third and fourth segments 124a, 124b, 124c, and
124d. The balloon segments 124 can have cylindrical configurations.
The balloon segments 124 can have segment sides 129, segment tops
126 and segment bottoms 128. The balloon segments 124 can be
attached to the adjacent segments at the segment sides 129. The
balloon segments 124 can be in fluid communication with each other
and the proximal stem, for example by a common inflation lumen, or
separately in fluid communication with proximal stem. The segments
can be inflated concurrently, in combinations (e.g., the first and
fourth segments concurrently, then the third and second segments),
or sequentially.
[0292] The proximal stem shown herein can be substituted in
variations for the hollow shaft and the hollow shaft can be
substituted in variations for the proximal stem.
[0293] FIG. 18 illustrates that the balloon can have anisotropic
compliance or elasticity characteristics across the balloon wall
22. For example, the balloon 20 can be less compliant or
substantially non-compliant parallel to the balloon longitudinal
axis, and more compliant perpendicular to the longitudinal
axis.
[0294] The balloon wall 22 can have a first unidirectional
fiber-reinforced laminate 130a oriented at a fiber angle 132 of
about 15.degree. relative to balloon the balloon longitudinal axis.
The balloon wall 22 can have a second unidirectional
fiber-reinforced laminate 130b oriented at a fiber angle 132 of
about -15.degree. relative to the balloon longitudinal axis. As the
pressure inside the balloon increases, the diameter of the balloon
adjacent to the balloon longitudinal axis can be substantially
constant. As the pressure inside the balloon increases, the
diameter of the balloon perpendicular to the longitudinal axis can
substantially increase.
[0295] FIGS. 19A and 19B illustrate that the balloon can have a
peanut configuration, like the balloon configuration shown in
Figures H and H'.
[0296] FIGS. 20A and 20B illustrate that a first balloon 20a can be
bonded to a second balloon 20b. The first balloon 20a can be bonded
to the second balloon 20b, for example along a bonded surface 138.
The bonded surface 138 can be parallel with the balloon
longitudinal axis.
[0297] FIGS. 21A and 21B illustrate that the balloon 20 can have a
flat balloon top and/or flat balloon bottom 116 and/or 118. The
balloon 20 can apply a uniform force across the balloon top and/or
bottom 116 and/or 118 to the endplates of the vertebrae.
[0298] The balloon 20 can be shaped to follow the contours of the
vertebral body. The balloon 20 can have a first lateral side 117a
and a second lateral side 117b. The first lateral side 117a can
have an inner radius of curvature. The second lateral side 117b can
have an outer radius of curvature. The inner radius of curvature
can be from about 5 mm to about 30 mm for example about 15 mm. The
outer radius of curvature can be from about 5 mm to about 30 mm for
example about 20 mm.
[0299] The inner radius of curvature side can face the posterior of
the vertebral body. The outer radius of curvature side can face the
anterior of the vertebral body.
[0300] FIGS. 22A and 22B illustrate that the balloon can have a
substantially cylindrical configuration and that the balloon top
and/or balloon bottom can curve when the balloon is in an expanded
or inflated configuration. The balloon top can have a balloon top
radius of curvature 140. The balloon bottom can have a balloon
bottom radius of curvature 142. The balloon top radius of curvature
140 can be substantially equal to or different from the balloon
bottom radius of curvature 142. The balloon top and/or balloon
bottom can be reinforced, for example altering the respective
radius of curvature. The balloon top or bottom radius of curvature
140 or 142 can be from about 250 mm to about 30 mm for example
about 60 mm.
[0301] FIG. 23A illustrates that the balloon can have a cylindrical
configuration oriented with the flat balloon top and flat balloon
bottom facing parallel with the balloon longitudinal axis.
[0302] FIG. 23B illustrates that the balloon top and/or balloon
bottom can be reinforced. For example, the balloon top and/or
bottom can have vanes, hard plastic or metal (e.g., tantalum)
discs, one, two or more layers of laminate compared to the wall of
the balloon side, or combinations thereof.
[0303] FIG. 23C illustrates that one, two or more internal
restraints 144 can be oriented longitudinally within the balloon.
For example, the internal restraints 144 can be fixed to the
balloon top and the balloon bottom.
[0304] FIG. 24A illustrates that the balloon can have a cube or
three-dimensional rectangular configuration. The balloon can have
six substantially flat balloon faces 146. The balloon faces 146 can
be oriented at a right angle to the adjacent balloon faces 146. The
balloon 20 can have a balloon edge 148 between adjacent faces.
[0305] FIG. 24B illustrates that the balloon 20 can have a one or
more first internal restraints 144a. The first internal restraints
144a can be non-compliant fibers or wires fixed to opposing balloon
faces. The first internal restraints 144a can be oriented
vertically or latitudinally within the balloon. The balloon can
have one or more second internal restraints 144b. The second
internal restraints 144b can be oriented perpendicular to the first
internal restraints 144a. The second internal restraints 144b can
be oriented laterally or latitudinally within the balloon. The
balloon can have one or more third internal restraints (not shown).
The third internal restraints can be oriented perpendicular to the
first and second internal restraints. The third internal restraints
can be oriented longitudinally within the balloon. The restraints
144 can terminate on in the inside surface of the balloon wall 22,
within the balloon wall 22 or on the outside of the balloon wall 22
(not shown).
[0306] FIG. 25 illustrates that a first balloon 20a can be inflated
though the first pressure inlet port 56. A second balloon 20b can
surround the first balloon 20a. The second balloon 20b can be
inflated though a second pressure inlet port 58. The first balloon
20a and the second balloon 20b can have different shapes when
inflated. The first balloon 30a and the second balloon 30b may be
inflated independently during a medical procedure. The first
balloon 30a can be used to create an initial lumen in the body. The
second balloon 30b can be used to shape or expand the initial lumen
in the body.
[0307] FIG. 26 illustrates that a first balloon 30a can be inflated
though the first pressure inlet port 56a. The second balloon 30b
can surround the first balloon 30a. The second balloon 20b can be
separated from the first balloon 20a by an inter-balloon gap 150.
The second balloon 20b can be in contact with the first balloon 20a
(i.e., the inter-balloon gap 150 can be 0). The second balloon 30b
can be inflated though the second pressure inlet port 58. The first
balloon 20a and the second balloon 20b can have different shapes
when inflated. The first balloon 20a and the second balloon 20b may
be inflated independently during a medical procedure. The second
balloon 20b can have holes in the balloon wall that leak inflation
material during an inflation cycle. The second balloon 20b can be
biocompatible. The inflation material can be bone cement. The bone
cement can cure and leave the second balloon 20b implanted in the
body. The first balloon 20a may be deflated and withdrawn before
the bone cement cures.
[0308] FIG. 27 illustrates that the balloon 20 can extend from a
lateral side of the hollow shaft 2000.
[0309] FIG. 28 illustrates that the balloons 20 can inflate from
one lateral side of the hollow shaft 2000. Pressure is provided
into the inflation lumen from the proximal end of the hollow shaft
2000. The balloons 20 may be of the same or different shapes. There
may be two balloons 20 attached to the hollow shaft 2000. There may
be four balloons attached to the hollow shaft 2000.
[0310] FIGS. 29A and 29B illustrate that the balloon 20 can have a
balloon first fluid port 56a at a first end and a balloon fluid
second 56b port at a second end. The balloon 20 can have a distal
stem 152 and a proximal stem. The balloon can have a longitudinal
through lumen. The distal taper angle can be from about 0 to about
90.degree., more narrowly about 40.degree. to about 15.degree., yet
more narrowly about 30.degree. to about 10.degree., for example
about 22.degree.. The proximal taper angle 90b can be from about 0
to about 90.degree., more narrowly about 40' to about 15.degree.,
yet more narrowly about 30.degree. to about 10.degree., for example
about 22.degree.. The distal blunting angle 92 can be from about 0
to about 90.degree., more narrowly about 50.degree. to about
85.degree., yet more narrowly about 60.degree. to about 80.degree.,
for example about 68.degree.. The distal blunting angle 92 can be
about equivalent to the distal taper angle 90b.
[0311] FIGS. 30A and 30B illustrate that the balloon 20 can have a
first segment 124a and a second segment 124b. The first segment
124a and the second segment 124b can be longitudinally concurrent.
The distal end of the balloon wall can be attached to the distal
end of the hollow shaft 2000 so the balloon wall 22 extends from
the proximal side of the attachment.
[0312] FIG. 30C illustrates that the distal end of the balloon can
be configured to extend distally past the attachment of the balloon
to the hollow shaft, for example past the distal end of the hollow
shaft. The shaft defining the inner lumen can translate in the
longitudinal direction with respect to the hollow shaft 2000.
[0313] FIGS. 31A and 31B illustrates that the distal end of the
balloon wall can be attached to the distal end of the hollow shaft
so the balloon wall extends from the distal side of the
attachment.
[0314] FIGS. 32A and 32B illustrates that the distal end of the
balloon wall can be attached to the distal end of the hollow shaft
so the balloon wall extends from the distal side of the attachment.
The proximal terminal end of the balloon can overhang the outer
hollow shaft.
[0315] FIGS. 33A and 33B illustrate that from the proximal end to
the distal end, the balloon can have a proximal taper, a first step
134a, a first step taper, a second step 134b, a second step taper,
a third step 134c, and a distal taper, or combinations thereof. The
first step 134a can have a first step radius 136a. The second step
134b can have a second step radius 136b. The third step 134c can
have a third step radius 136c. The first step radius 136a can be
greater than or less than (as shown) the second step radius 136b.
The second step radius 136b can be greater than or less than (as
shown) the third step radius 136c. The first step radius 136a can
be greater than or less than (as shown) the third step radius
136c.
[0316] During use, the increasing radii steps can be used to
measure the target site and use the best size of balloon without
having to remove the balloon from the patient and delivering a
second balloon to the target site. For example, the balloon can
sequentially dilate a stenotic vessel or valve with increasing
known radii (e.g., instead of purely by feel) of dilation.
[0317] FIGS. 34A and 34B illustrate that the first step radius and
the third step radius can be substantially equal. The second step
radius can be less than the first step radius and the third step
radius.
[0318] FIG. 34C illustrates that a radially expandable implant 156
can be removably attached to the balloon wall 22. For example, a
stent, a percutaneous aortic heart valve, a replacement heart valve
annulus, or combinations thereof, can be balloon-expandable and
deformed into the second step before insertion of the balloon into
the target site.
[0319] FIG. 35A illustrates that an inflation device can lave a
first balloon 20a and a second balloon 20b. The second balloon 20b
can be longitudinally distal to the first balloon 20a. The first
balloon can be directly attached to the second balloon. The first
balloon 20a can be attached to a proximal end of a balloon joint
158. The second balloon 20b can be attached to a distal end of the
balloon joint 158.
[0320] The first balloon can be in fluid communication with the
second balloon. The first balloon can be inflated and/or deflated
concurrent with the second balloon. The first balloon can be in
fluid isolation from the second balloon. The first balloon can be
inflated and/or deflated precedent or subsequent to the second
balloon's inflation or deflation.
[0321] The distal terminal end of the second balloon 20b can have a
balloon second fluid port 56b. The balloon second fluid port 56b
can be in fluid communication with the hollow shaft 2000 and/or the
first and/or second balloons 20a and/or 20b.
[0322] FIG. 35B illustrates that the fluid port can be in fluid
communication with an inner lumen. The inner lumen and balloon
second fluid port can be made of a material that does not bond to
or degrade by exposure to common bone cements, such as methyl
methacrylate. A middle lumen 154c can be in fluid communication
with the interior of the second balloon 20b. The middle lumen 154c
can inflate the second balloon 20b.
[0323] The outer lumen 154b can be in fluid communication with the
interior of the first balloon 20a. The outer lumen 154b, can
inflate the first balloon 20a. Various pumps, syringes or pressure
sources (not shown), or combinations thereof, can attach and
deliver fluid pressure to the inner, middle or outer lumens 154a,
154c, 154b.
[0324] The device 2 can be inserted into a structure in the body.
The structure can be bone. As described herein, the first and
second balloons 20a and 20b can be inflated to create a balloon
void in the body structure. One of the balloons 20 can be deflated
and left in the body. An adhesive, (for instance, bone cement) can
be injected though the inner lumen 154a and emerge from the balloon
second fluid port 56b into the balloon void created in the body.
The adhesive can fill or partly fill the portion of the balloon
void created by the just-deflated balloon. The adhesive can cure
while the other balloon remains inflated. The remaining balloon can
then be deflated and the inflation system withdrawn. Adhesive can
be injected to fill or partially fill the lumen created in the body
structure by the inflation system. More than two balloons (e.g.,
three or four) can be used with the inflation system.
[0325] FIGS. 36A and 36B illustrate that the balloon 20 can have a
toroidal or annular shape. A fluid conduit 176 can extend from the
hollow shaft 2000 to the balloon 20. The fluid conduit 176 can
delivery fluid pressure to inflate and deflate the balloon 20. The
balloon 20 can have an inner wall 22a and an outer wall 22b. The
inner wall 22a can be radially inside the outer wall 22b. The
balloon 20 can have an annular lumen 160 passing through the radial
center of the balloon 20. The annular lumen 160 can open to an
annular lumen distal port 162a and an annular lumen proximal port
162b.
[0326] The distal end of the annular lumen 160 can be attached to
one or more distal tensioners 164a. The distal tensioners 164a can
be elastic or inelastic wires, fibers or threads. The distal
tensioners 164a can be fixed at distal tensioner first ends evenly
or unevenly angularly distributed around the distal end of the
balloon 20. The distal tensioners 164a can attach at distal
tensioner second ends to a distal tension anchoring wrap 166a. The
distal tension anchoring wrap 166a can be fixed to the hollow shaft
2000.
[0327] The proximal end of the annular lumen 160 can be attached to
one or more proximal tensioners 164b. The proximal tensioners 164b
can be elastic or inelastic wires, fibers or threads. The proximal
tensioners 164b can be fixed at proximal tensioner first ends
evenly or unevenly angularly distributed around the proximal end of
the balloon. The proximal tensioners 164b can attach at proximal
tensioner second ends to a proximal tension anchoring wrap 166b.
The proximal tension anchoring wrap 166b can be fixed to a
tensioning collar 168.
[0328] The second step can form a waist. The waist can have
additional hoop wrapped fibers. The waist can be substantially
non-compliant. The waist can be from about 0 mm to about 12 mm in
the balloon longitudinal direction, more narrowly from about 3 mm
to about 9 mm. The waist diameter can be from about 2 mm to about
35 mm, for example about 3 mm, about 6 mm, about 20 mm, or about 23
mm.
[0329] The tensioning collar 168 can be slidably attached to the
hollow shaft 2000. The tensioning collar 168 can translate
longitudinally, as shown by arrows in FIG. 36B, along the shaft.
The tensioning collar can be pulled and/or pushed by a control line
170 or rod. Before deployment of the inflatable device and after
deployment but before removal of the inflatable device, the balloon
can be deflated and contracted against the hollow shaft. For
example, the control line can be pulled to retract the proximal end
of the balloon. For example, the balloon can fold and contract
against the hollow shaft. The balloon may be pleated such that,
when the tensioning collar is pulled or when a vacuum is applied
tot the inflatable device, the balloon contracts into a small,
packed form (not shown).
[0330] The balloon can have a distal segment 172a and a proximal
segment 172b. The distal segment 172a and the proximal segment 172b
can be annular or toroidal. The annular or toroidal planes can be
perpendicular to the balloon longitudinal axis 26. The distal
segment 172a can be longitudinally adjacent to the proximal segment
172b. The distal segment 172a can be directly bonded to the
proximal segment 172b or joined to the proximal segment 172b by a
segment joint 174. The segment joint 174 can be open and allow
fluid communication between the proximal segment 172b and the
distal segment 172a (not shown) or can be closed to isolate the
fluid volume or the proximal segment 172b from the fluid volume of
the distal segment 172a.
[0331] The distal segment and/or the proximal segment may be
inflated by a tube. The tube may be attached to the hollow
shaft.
[0332] The outer wall, the inner wall, or both walls, may contain a
radiopaque material as described herein.
[0333] The outer wall of the distal segment can form the first
step. The segment joint can form the second step. The outer wall of
the proximal segment can form the third step. The second step can
be radially smaller than the first step and the second step. A
device, such as a minimally invasive replacement heart valve can be
attached to the outside of the balloon.
[0334] FIGS. 37A and 37B illustrate that the device (shown in 36A
and 36B) can have a valve 178. The valve 178 can have a first
leaflet 180a, a second leaflet 180b, a third leaflet (not shown),
or more. The leaflets 180 can be thin and flexible. The leaflets
180 can collapse inside the annular lumen when the balloon is in a
contracted configuration. The valve can allow flow through the
annular lumen 160 in the distal direction and prevent flow through
the annular lumen 160 in the proximal direction. The valve 178 can
be fixed to the distal end of the distal segment of the balloon.
The leaflets 180 can be oriented to allow flow distally through the
annular lumen and impede or prevent flow proximally through the
annular lumen. The leaflets 180 can be oriented to allow flow
proximally through the annular lumen and impede or prevent flow
distally through the annular lumen.
[0335] FIG. 38A illustrates that the balloon can have segments that
can be angularly adjacent to each other. For example, the segments
and the segment joints can be parallel with the longitudinal axis.
The second step can have a larger radius than the first step or the
third step. The proximal and distal tensioners can attach to the
segments and/or segment joints.
[0336] The segments may be inflated by a tube. The tube may be
attached to the hollow shaft 2000. The distal and/or proximal
tensioners can attach to the balloon at the segment joints and/or
at the segments.
[0337] The segment walls can have a radiopaque foil and/or a wire,
such as a radiopaque marker wire.
[0338] FIG. 38B illustrates that the segments can be in fluid
isolation from each other at the length along the balloon shown in
Figure M1. The segments can have a flattened circle longitudinal
cross-sectional configuration. For example, the segments can be
almond or eye-shaped.
[0339] FIG. 38C illustrates that the segments can be in fluid
communication with each other at a length along the balloon shown
in Figure M1.
[0340] FIG. 38D illustrates that the segments can have a circular
longitudinal cross-sectional configuration. For example, the
segments can be cylindrical.
[0341] FIGS. 39A and 39B illustrate that the balloon can have a
constant outer diameter when measured along the longitudinal axis
nope, it won't quite do that. For example, the balloon can have a
single step. The balloon can have an inner wall 22a, an outer wall
22b and segment joints 174. The segment joints 174 can connect the
inner wall to the outer wall. The segment joints 174 can minimize
the inward radial collapse of the inner wall during inflation.
[0342] FIG. 39C illustrates that the hollow shaft can have an inner
lumen 154a and an outer lumen 154b. The fluid conduit can be in
fluid communication with the outer lumen and the balloon. The outer
lumen can deliver pressure through the fluid conduit and to the
balloon. The inner lumen can be a through lumen. The outer lumen
can extend through the distal proximal tip.
[0343] FIG. 40 illustrates that the balloon can have a spiral or
helical configuration. The spiral can have a first winding 182a, a
second winding 182b, and more (e.g., five, as shown) windings. The
first winding 182a can be joined to the second winding 182b at a
winding joint 184. The winding joint 184 can have an adhesive or a
weld joint. The winding joint 184 can have a strip of elastic or
inelastic material attached to the adjacent windings. The balloon
20 can be formed from a single continuous lumen.
[0344] FIG. 41A illustrates that the first flute can have a first
vane 186a. The second flute can have a second vane 186b. The vanes
186 can be embedded within or attached to the inside or outside of
the balloon wall 22. All, some, one, or none of the flutes can have
vanes. The vanes 186 can be reinforcements. For example, the vanes
186 can be a laminate, foil or wafer. The foil or wafer can be a
plastic or metal listed herein, such as tantalum. The vane 186 can
be strong enough to cut soft or hard tissue adjacent to the pleat.
The vanes 186 can be rigid or flexible.
[0345] FIG. 41B illustrates that in an inflated or expanded
configuration, the vanes 186 can lie flat along the wall.
[0346] A single radiopaque layer can encompass substantially the
entire area of the balloon (as shown in FIG. 1, but with a
radiopaque layer congruent with the balloon 20). The radiopaque
layer can be a tantalum or other metal foil selected from a
radiopaque metal such as those listed herein. The radiopaque layer
can be a single continuous layer, for example as a deposition or
foil lining with e.g. a deposition or foil of a metal such as
tantalum. FIG. 42A illustrates that the balloon can have vanes can
be spaced evenly around the balloon longitudinal axis. The vanes
can be radiopaque and/or echogenic. The vanes can be rectangular,
triangular, circular, oval, or combinations thereof. The vanes can
be oblong having a major axis and a minor axis. The major axis can
be parallel with the balloon longitudinal axis.
[0347] FIG. 42B illustrates that the balloon can have first vanes
spaced evenly around the balloon longitudinal axis. The balloon can
have one or more second vanes at the balloon distal terminal
end.
[0348] FIG. 42C illustrates that the balloon can have a third vane
at the proximal taper. The second and/or third vanes can partially
or completely circumferentially envelope the balloon around the
balloon longitudinal axis.
[0349] FIG. 42D illustrates that the balloon can have marker spots
188 evenly or unevenly distributed around the balloon. The marker
spots 188 can be radiopaque and/or echogenic. The marker spots 188
can be circular, oval, square, triangular, rectangular, pentagonal,
hexagonal, or combinations thereof. The marker spots 188 can be in
a layer of the balloon wall or attached to the inner or outer
surface of the balloon wall.
[0350] 42E illustrates that the balloon can have a marker wire 190
in a helical configuration about the balloon longitudinal axis. The
marker wire 190 can be radiopaque and/or echogenic. The wires 190
can be electrically conductive. The wires 190 can carry electrical
current, for example for RF delivery, resistive heating, or
combinations thereof. The marker wire 190 can be in a layer of the
balloon wall or attached to the inner or outer surface of the
balloon wall 22.
[0351] The marker wire 190 can carry a tensile load. For example,
the wire can have a 0.001 in. diameter and maintain a tensile load
of 0.3 N without yield or failure. The wire can be gold.
[0352] The marker wire 190 or another configuration of a panel or
wire, such as shown in FIG. 45, can be a resistive heating or RF
element. The system can have a power supply for delivering energy,
such as electrical current, to the resistive heating element. The
system can have a heat control unit for controlling the level of
energy delivery to the resistive heating element. The heating
element can be separated positive and negative electrodes on the
balloon wall outer surface and contact the target site tissue
directly, within the balloon wall, or on the radial inside of the
inside surface of the balloon, or combinations thereof. The heating
element can have a dielectric material. Radiofrequency energy can
be delivered across the dielectric material of the heating element
to create ohmic heating in the tissue.
[0353] The vanes 186, the marker spots 188 and the wires 190 can be
on the inside of the balloon wall 22, the outside of the balloon
wall 22, or within the balloon wall 22.
[0354] FIG. 43 illustrates a panel 196 that can be configured as an
elongated member or strip 192 that can be placed in a layer of the
balloon wall. The strip 192 can have a strip longitudinal axis 194.
The strip 192 can have one or more reinforcement fibers, for
example, parallel and/or perpendicular with the strip longitudinal
axis 194. The strip can have one or more vanes. For example, the
strip can have multiple rows of vanes.
[0355] FIG. 44 illustrates a panel can have one, two, three, four,
five, six (as shown) or more panel arms 200, such as panel first
arm 200a and panel second arm 200b. The 196 panel can be a rosette.
The panel 196 can have a panel center 198. The panel arms 200 can
extend from the panel center 198. The panel arms 200 can have arm
longitudinal axes. The angle between adjacent arm longitudinal axes
can be arm angles 202.
[0356] The panel or radiopaque foil pattern can have panel arms
that can be folded over a balloon 20 during manufacture such that
radiopaque foil panel can be embedded within the balloon wall 22.
The radiopaque foil and any other radiopaque or metal element
herein can be made from gold, platinum, platinum-iridium alloy,
tantalum, palladium, bismuth, barium, tungsten, or combinations
thereof. Any of the layers can have particles of gold, platinum,
platinum-iridium alloy, tantalum, palladium, bismuth, barium,
tungsten or combinations thereof. Any of the layers can have
radiopaque dyes.
[0357] The foil can be less than about 30 .mu.m thick, for example
less than about 20 .mu.m thick, for example about 15 .mu.m, about
12 .mu.m, about 10 .mu.m or about 8 .mu.m thick. Radiopaque foils
can be cut or patterned by laser cutting, wire EDM, die cutting or
deposition. The foils may be mounted to a removable backing before
cutting such that a pattern of foils may be easily applied during
the balloon construction process.
[0358] The panels and/or vanes can cover the distal half of the
balloon. The panels and/or vanes can cover the proximal half of the
balloon. The panels and/or vanes can overlap in the longitudinal
center of the balloon.
[0359] The panel, such as a foil, can be located in the balloon
wall 22 in an area that is exposed to increased stresses during
inflation. A radiopaque foil can strengthen the balloon wall
22.
[0360] The balloon 20 can have pleats or flutes between vanes or
panels. The vanes or panels can form the pleats or flutes. A panel
or vane, such as a radiopaque foil, can minimize leaks from forming
between fibers in the balloon during use.
[0361] FIG. 45 illustrates that the balloon can have a resistive
heating element 204 in a layer of the balloon wall or on the radial
outside or radial inside of the balloon wall. The heating element
204 can have a resistive wire on a panel. The panel can be made
from copper or another metal. The heating element 204, such as the
resistive wire or panel, can be connected to a heating lead 206.
The heating lead 206 can extend proximally along the hollow shaft
2000. The heating lead 206 can be proximally connected to a
controller and power source. The balloon 20 can be used to heat,
cool (e.g., when the panel is a Peltier junction), emit RF power,
or combinations thereof.
[0362] The heating element can be substituted for or configured in
combination with a UV-emitting element, visible light-emitting
element, microwave-emitting element, ultrasonic-emitting element,
or combinations thereof. The heating element 204 can be replaced or
configured with a strain gauge, a peltier junction or a temperature
measuring device, or combinations thereof.
[0363] The balloon can be used to treat abnormal mucosa in an
esophagus, for example by positioning the heating element near or
in contact with the abnormal mucosa and delivering heat. The
mucosal layer of the esophageal wall, for example the columnar
epithelium, can be injured or ablated and made necrotic with the
balloon to normalize mucosa in the esophagus.
[0364] FIG. 46A illustrates that the balloon wall 22 at section
BB-BB or at other sections taken through a single wall of the
balloon can have a layer 72 that can have a fiber tape matrix. The
fiber tape matrix can have one or more reinforcement fibers 86 and
one or more resins. The resin can be a flexible adhesive 208. The
flexible adhesive can remain flexible when cured or melted to form
the medical inflatable device 2.
[0365] The fiber tape (also referred to as unidirectional fiber
reinforced tape, unidirectional tape, and uni-tape) may have one,
two or more monofilaments 86 running substantially parallel to each
other and embedded in a flexible adhesive 208. Uni-tape may be
produced with a removable backing. The removable backing can be
made of paper, plastic, film, metal, elastomer, foam, fabric or
combinations thereof. The substantially parallel monofilaments may
be positioned within the flexible adhesive such that they are
touching each other along their length. The substantially parallel
monofilaments may be positioned such that there is flexible
adhesive separating each fiber along its length.
[0366] FIG. 46A illustrates fiber array layer 72 having a layer
width 210 in cross-section. The layer width 210 can include a
number of fibers 86, for instance first fiber 86a and second fiber
86b. The layer 72 can have a linear quantity fiber density
measured, for example, as the number of fibers 86 per unit of layer
width 210. The linear quantity fiber density can be equal to or
greater than about 500 fibers per inch, more narrowly equal to or
greater than about 1000 fibers per inch, more narrowly equal to or
greater than about 2000 fibers per inch, yet more narrowly equal to
or greater than about 4000 fibers per inch. For example, the liner
quantity fiber density can be from about 1,000 fibers per inch to
about 2,000 fibers per inch.
[0367] The fibers 86 or monofilaments can be high strength and
inelastic. The fibers can have a fiber or monofilament diameter
212, for example, from about 1 .mu.m to about 50 .mu.m, for example
less than about 25 .mu.m, more narrowly less than about 15 .mu.m.
The unidirectional fiber-reinforced tape can have the same or
different sizes and materials of fibers within the same
unidirectional fiber-reinforced tape.
[0368] The fiber tape layer 72 can have a layer thickness 216 from
about 1 .mu.m to about 50 u .mu.m, more narrowly from about 8 .mu.m
to about 25 .mu.m, yet more narrowly from about 10 .mu.m to about
20 .mu.m.
[0369] FIG. 46B illustrates that the fiber density can be less than
the fiber density shown in FIG. 46A. For example, the fiber density
can be about 500 fibers per inch.
[0370] FIG. 46C illustrates that the inner layer 72b can have a
fiber tape having reinforcement fibers 86 in an adhesive 208. The
outer layer 72a can have a polymer film. The laminate shown can be
a part of or the entire balloon wall 22,
[0371] FIG. 46D illustrates that the outer layer 72a can be a fiber
tape. The inner layer 72b can be a polymer film.
[0372] FIG. 46E illustrates that the outer layer 72a and the inner
layer 72b, can be polymer films. In any variation, the polymer
films can be the same or different polymers, or any combination
thereof. The first middle layer 72c can be a fiber tape.
[0373] FIG. 46F illustrates that the outer layer 72a, inner layer
72b, and second middle layer 72d can be polymer films. The first
middle layer 72c can be a fiber tape. Any adjacent layers, such as
the third middle layer 72e and the outer layer 72a can be joined
with adhesive, by melting, solvation, welding or combinations
thereof.
[0374] FIG. 46G illustrates the outer layer 72a, inner layer 72b,
first middle layer 72c and third middle layer 72e can be polymer
films. The second middle layer 72d can be a fiber tape.
[0375] FIG. 46H illustrates that the outer layer 72a can be a first
fiber tape. The inner layer 72b can be adjacent to the outer layer
72a. The inner layer 72b can be a second fiber tape. The first and
second fiber tapes can be uni-tapes. The fiber in first fiber tape
can form an angle with the fiber in the second fiber tape. Part or
all of the balloon wall 22 can have multiple fiber tape layers in a
wall section area 131. The area 131 can include a number of
fibers.
[0376] Part or all of the balloon wall 22 can have a volumetric
quantitative density of fibers measured, for example, as the number
of fibers per unit of area. The area quantity fiber density can be
equal to or greater than about 100,000 fibers per square inch, more
narrowly equal to or greater than about 250,000 fibers per square
inch, more narrowly equal to or greater than about 1,000,000 fibers
per square inch, yet more narrowly equal to or greater than about
4,000,000 fibers per square inch. The area quantity of fiber can be
about 25% of the area of a wall cross section, more narrowly about
50%, more narrowly about 75%
[0377] The ratio of the volume of the fiber tape to the volume of
the fibers 86 can be about equal to or greater than about 15%, more
narrowly equal to or greater than about 30%, more narrowly equal to
or greater than about 50%, yet more narrowly equal to or greater
than about 75%.
[0378] FIG. 46I illustrates that a balloon wall 22 can be made by
positioning, as shown by arrows, an inner layer 72b having a first
laminate 130a on the outer layer 72a having a second laminate 130b.
The first laminate 130a can be consolidated to the second laminate
130b. Consolidation can include heating, pressurizing, solvating,
or combinations thereof of the first laminate 130a and the second
laminate 130b.
[0379] FIG. 46J illustrates that the outer layer 72a, and inner
layer 72b can be polymer films. The first middle layer 72c and the
second middle layer 72d can be fiber tapes.
[0380] FIG. 46K illustrates that the outer layer 72a, inner layer
72b, second middle layer 72d, and third middle layer 72e can be
polymer films. The first middle layer 72c and the fourth middle
layer 72f can be fiber tape.
[0381] FIG. 46L illustrates that the balloon wall 22 can be made by
positioning, as shown by arrows, a first laminate 130a on a second
laminate 130b. The first laminate 130a can be consolidated to the
second laminate 130b. The first laminate 130a can have the outer
layer fixed to the fourth middle layer, which can be fixed to the
third middle layer. The second laminate 130b can have the inner
layer fixed to the first middle layer, which can be fixed to the
second middle layer.
[0382] FIG. 46M illustrates that the outer layer 72a, inner layer
72b, second middle layer 72d, third middle layer 72e, fifth middle
layer 72g, and sixth middle layer 72h can be polymer films. The
first middle layer 72c, fourth middle layer 72f and seventh middle
layer 72i can be fiber tapes.
[0383] FIG. 46N illustrates that the balloon wall 22 can be made by
joining, as shown by arrows, a first laminate 130a, a second
laminate 130b, and a third laminate 130c.
[0384] FIG. 46O illustrates that the outer layer 72a can be an
MMA-resistant and MMA-releasing polymer film. The inner layer 72b
can be a leak proof bladder made from a polymer film. The first
middle layer 72c can be a fiber tape, for example with the fibers
oriented as longitudinal fibers. The second middle layer 72d can be
a resin or adhesive. The third middle layer 72e can be a fiber
tape, for example with the fibers oriented as latitudinal or hoop
fibers. The fourth middle layer 72f can be a resin or adhesive. The
fifth middle layer 72g can be a radiopaque layer, such as a metal
foil. The sixth middle layer 72h can be a resin or adhesive.
[0385] Any of the polymer or fiber tape layers can be leak proof,
water tight, air tight, MMA-resistant, MMA-releasing, or
combinations thereof.
[0386] Magnetic resonance visualization enhancement materials, such
as magnetic contrast agents, can be added to the adhesive, the film
or the fiber. The magnetic resonance visualization enhancement
materials can enhance the visualization of the balloon during an
magnetic resonance imaging (MRI) procedure. For example, the
magnetic resonance visualization enhancement material can be
gadolium, Omniscan, Optimark, ProHance, Magnevist, Multihance, or
combinations thereof.
[0387] Any of the layers, for example the outer layer, can be
tinted or dyed a visible spectrum color. For example, a pigment,
coloring additive, dispersions or other coloring agents, such as an
coloring additive from Plasticolors (Ashtabula, Ohio) can be added
to the adhesive, laminate or fiber before consolidation. A paint or
coating can be added to a layer surface or to the outer surface of
the balloon wall.
[0388] The color can be selected for branding, market
differentiating, as an indication of the type of device, the size
of the device, or combinations thereof. For example, devices having
a selected diameter, length, pressure rating, clinical indication
or efficacy, other common performance metric, or combinations
thereof, can be dyed a specific color (e.g., green for a first type
of device, red for a second type of device).
[0389] The layers can have one or more optical fibers. The fiber
optic can be a strain sensor. The strain sensor can monitoring the
laminate's mechanical status in real time. The fiber optic can
guide light delivery into the body. The fiber optic can visualize a
target site (e.g., gather light from the body to produce a visual
image).
[0390] FIG. 47 illustrates polymer films from which the layers can
be made. The thickness of the polymer films can be from about 2
.mu.m to about 50 .mu.m, more narrowly from about 2 .mu.m to about
18 .mu.m, yet more narrowly from about 4 .mu.m to about 12
.mu.m.
[0391] FIG. 48 illustrates materials from which the reinforcement
fibers can be made.
[0392] FIG. 49 illustrates that the adhesive can be an elastomeric
thermoset material, an elastomeric thermoplastic material, or a
combination thereof. The adhesive can be selected from any of the
materials, or combinations thereof, listed in FIG. 49. The matrix
can have a resin and a fiber. The resin can be an adhesive.
Method of Manufacture
[0393] FIGS. 50 and 51 illustrate that the device can be partially
or completely manufacturing in a pressure chamber 219. The pressure
chamber 219 can be in a pressure chamber case 218. The pressure
chamber case 218 can have a case top 220a separatable from a case
bottom 220b. The case top 220a can have a case top port 222. The
case bottom 220b can have a case bottom port 224. The case top port
222 can be in fluid communication with the top of the pressure
chamber 219. The case bottom port 224 can be in fluid communication
with the bottom of the pressure chamber 219.
[0394] The case top can screw or otherwise tightly join to the case
bottom. The pressure chamber case can have one or more o-rings (not
shown) in o-ring seats 226.
[0395] The pressure chamber can have a mandrel seat 228. The
mandrel seat 228 can be configured to receive a mandrel 230. The
mandrel seat 228 can have holes or pores. The holes or pores in the
mandrel seat 228 can allow pressure from the case bottom port and
the bottom of the pressure chamber to reach the top surface of the
mandrel seat around the mandrel and/or directly under the
mandrel.
[0396] The mandrel 230 can have the inner dimensions of the balloon
20.
[0397] The mandrel 230 can be a water soluble mandrel. The mandrel
may be made from a low melting point wax or metal, a foam, some
collapsing structure or an inflatable bladder. The mandrel can be
made from a eutectic or non-eutectic bismuth alloy and removed by
raising the temperature to the melt point of the metal. The mandrel
can be made from aluminum, glass, sugar, salt, corn syrup,
hydroxypropylcellulose, ambergum, polyvinyl alcohol (PVA, PVAL or
PVOH), hydroxypropyl methyl cellulose, polyglycolic acid, a ceramic
powder, wax, ballistic gelatin, polylactic acid, polycaprolactone
or combinations thereof.
[0398] FIG. 52 illustrates characteristics of bismuth alloys from
which the mandrel can be made. The characteristics are
characterized by melting temperature (as shown in the third row of
FIG. 52) of the bismuth alloy.
[0399] The mandrel can be transparent or translucent to light
and/or an electron beam. The mandrel can be hollow. The outside
surface of the mandrel can be coated in a release agent.
[0400] The mandrel may be molded, machined, cast, injection molded
or combinations thereof.
[0401] The mandrel can be in the mandrel seat and a first panel to
be formed into about half of the inner layer of the balloon wall
can be placed between the case top and the case bottom. The case
top can then be secured to the case bottom.
[0402] FIG. 53 illustrates that the outer surface of the mandrel
can have some glue or first adhesive. The first adhesive can be
located around the perimeter of the first panel's contact area with
the mandrel. The first adhesive can be water soluble. The first
adhesive can be a sugar syrup.
[0403] FIG. 54 illustrates that a positive pressure can be applied
to the top of the pressure chamber (e.g., through the case top
port) and/or a negative pressure or suction applied to the bottom
of the pressure chamber (e.g., through the case bottom port). The
layer can get sucked and/or pressed down onto the mandrel. The
first panel can be smoothly fitted to the mandrel and adhered to
the mandrel at the first adhesive.
[0404] FIG. 55 illustrates that the mandrel and layer can be
mounted into a trimming jig 231. Any excess portion of the first
panel extending from the mandrel can be trimmed with a blade 235,
with a laser, with a water jet cutter or with a die cut tool. The
trimming jig 231 can cover the mandrel and the first panel attached
to the mandrel. Several layers can be formed over the mandrel and
cut. The layers may be trimmed at the same time or one at time.
[0405] FIG. 56 illustrates that the mandrel can have the excess
area or the first panel removed in preparation for attachment to
the second panel.
[0406] FIG. 57 illustrates that a second adhesive can be applied to
the first panel around the perimeter of the second panel's contact
area with the first panel. The second adhesive can be an epoxy,
urethane, a cyanoacrylate, a UV cure, or combinations thereof. The
mandrel can be seated in the mandrel seat with the first panel in
the mandrel seat. The second panel can be placed on the mandrel as
shown (upside down relative to the FIGS. 50 and 51 for illustrative
purposes).
[0407] FIG. 58 illustrates that after the case top is secured to
the case bottom, the positive and/or negative pressures can be
applied to the pressure chamber as described infra. The second
panel can be smoothly fitted or pressure formed to or against the
mandrel and adhered to the first panel at the second adhesive. The
first and second panels can form the inner layer of the balloon
wall. Multiple layers can be made by repeating the method described
infra. The pressure chamber can be heated, for example, to decrease
the viscosity of and decrease the modulus of the panels.
[0408] FIG. 59A illustrates that a layer of fiber tape can be made
on a roller 232. The roller can be configured to rotate about a
roller axle 234. The roller may have a diameter from about 1 mm to
about 100 mm. The roller may be made or coated with an anti-stick
material such as a flouropolymer.
[0409] FIG. 59B illustrates that a releaser 236, such as a release
layer, can be placed around the circumference of the roller 232.
The release layer can be a low friction film or coating. The
release layer may be a thin/flexible flouropolymer sheet.
[0410] FIG. 59C shows that an adhesive layer can be placed on the
releaser or directly onto the roller (e.g., if no releaser is
used). The adhesive layer may be a thermoplastic film. The adhesive
layer may be a thermoset adhesive. The adhesive layer may be a
solvated thermoplastic or thermoset.
[0411] FIG. 59D shows the application of fiber to the roller. Fiber
may be unwound from a spool (not shown) and rolled onto the top
surface of the adhesive. The fiber may contain one or more
monofilaments. The fiber may have been previously flattened as
detailed in this application. Any coating or sizing on the fiber
may have been removed using a solvent. The fiber may be placed with
a gap between each successive fiber wrap. The gap may be less than
25 .mu.m, preferably less than 5 .mu.m.
[0412] FIG. 59E shows a reinforcement layer on top of the adhesive
on top of the release layer.
[0413] FIG. 59F illustrates that the roller can be placed between a
vacuum top sheet 238a and a vacuum bottom sheet 238b, for example
in a vacuum bag. A vacuum seal tape 240 can surround the roller
between the vacuum bottom and top sheets. The air can be removed
from between the vacuum top and bottom sheets and within the vacuum
seal tape, for example by suction from a suction tube 242. Inside
and/or outside of the vacuum bag, the roller can be heated, for
example to melt or cure the adhesive.
[0414] FIG. 59G shows the removal of the layer. For instance, a cut
may be made substantially perpendicular to the fiber. The layer may
be peeled away from the release layer.
[0415] FIG. 59H illustrates that the layer of fiber tape can be
removed from the roller. For example, the layer can be peeled off
the releaser.
[0416] The layer can be cut into a pattern. For instance, the layer
can be cut with the trimming jig, a laser, a water jet cutter, a
die cut tool, or a combination thereof. The layer can be cut to
form a strip similar to the one shown in FIG. 121.
[0417] FIG. 60 illustrates that a strip can be applied to the inner
layer or the mandrel. Each strip can be placed around the distal
terminal end of the mandrel. The circular section may be centered
on the distal end of the mandrel. The strips may be adhered to the
mandrel using an adhesive or by melting the adhesive such that it
bonds to the underlying layer.
[0418] FIG. 61 illustrates that a first, second and third strip can
be laid onto the mandrel. For example, the strips can be placed on
the inner (or another) layer 72. The strips can cover the outermost
(at the time the strips are applied) layer. The ends of the strips
can end on the proximal taper or proximal stem.
[0419] FIG. 62 illustrates that the circular sections of each strip
can line up with each other. The circular sections can be aligned
with the balloon distal terminal end. There may be fibers located
approximately every 60 degrees at the distal tip
[0420] FIG. 63 illustrates that fiber can be wound over the
mandrel. For example, a tool arm 246 can be attached to a rotating
tool wheel 248. The mandrel can be rotated, as shown by arrow 252,
about the mandrel longitudinal axis 250 or balloon longitudinal
axis. The spool 244 can be passively (e.g., freely) or actively
rotated, as shown by arrow 254, deploying the fiber. Before
winding, the fiber may be infused with an adhesive, a solvent, or
both. A fiber distal end can fix to the top layer or directly to
the mandrel. The tool arm 246 can rotate and translate, as shown by
arrows 256 and 258, to track the tool wheel with the surface of the
top layer.
[0421] The tool wheel can press the fiber against the top layer.
The tool wheel can be heated to soften or melt the material on the
surface of the top layer. Another heat source may be used to tack
the fiber in place. For example, a separate resistive heater, a
laser, or an RF welder may be used. The tool wheel can be made of
or coated with a non-stick material. The fiber may be wound with a
gap between each successive fiber wind. The gap can be less than
about 25 .mu.m, more narrowly less than about 5 .mu.m. The winding
process can terminate substantially before reaching the distal tip.
The winding process can terminate when the fiber reaches the area
where the strips overlap.
[0422] The resulting layer deposited in FIG. 63 can have a layer
thickness of from about 1 .mu.m to about 50 .mu.m, more preferably,
8 .mu.m to about 25 .mu.m.
[0423] FIG. 64 illustrates that a string, wire or fiber can be
helically wrapped around the mandrel, for example on the inner (or
another) layer.
[0424] FIG. 65 illustrates that a rosette, vanes, or spots of a
single panel can be placed onto the mandrel. The panel can be made
from a metal foil: The rosette may be that shown in FIG. 44. The
panel may provide radiopacity to the balloon. The panel may
strengthen the balloon. The panel may make the balloon
significantly more resistant to puncture.
[0425] Any methods of adding a layer to the mandrel or previous
layer can be repeated to add additional layers, such as an outer
layer of an MMA-resistant film.
[0426] The mandrel and the layers, including the panels, strips,
wires or fibers, rosette, or combinations thereof, can be adhered,
heated and/or pressurized, for example, to melt solvate, or
otherwise bond the layers, for example by creating molecular bonds
and decreasing the viscosity and modulus of the layers.
[0427] FIG. 66 illustrates that after the layers of the balloon
have been assembled on the mandrel, a distal caul 260a can be
placed over the distal end of the balloon. A proximal caul 260b can
be slid over the mandrel and the proximal end of the balloon. The
proximal caul 260b can be sealed to the distal caul 260a. The cauls
260 can be made from a flouropolymer. The cauls 260 can have
thermoformed FEP with a 0.005 in. initial thickness.
[0428] FIG. 67 illustrates that the mandrel, balloon and cauls can
be placed into a vacuum bag. The balloon proximal stem and/or the
mandrel can be placed inside of a vacuum bag. The interior of the
vacuum bag can be heated. The vacuum bag can be inserted inside of
an oven or autoclave. The layers of the balloon on the mandrel can
be thermally cured or melted, for example under from about 1 ATM to
about 30 ATM of pressure.
[0429] The bag delivery channel can suction the interior of the
vacuum bag. For example the pressure in the vacuum bag can be less
than about 0.1 ATM.
[0430] FIG. 68 illustrates that a wash tube 264 can be inserted
into a mandrel washout port 262. A dissolving or solvating fluid
can be delivered through the wash tube and into the washout port.
The mandrel can be removed by delivery of a fluid solvent such as
water, alcohol or a ketone. The solvent may be applied during the
consolidation process such that the solvent melts or partially
softens the mandrel and concurrently pressurizes the bladder. The
mandrel can be removed by raising the mandrel to a melting
temperature for the mandrel. The mandrel can be removed by
deflating the mandrel or by collapsing an internal structure.
[0431] The balloon may be expanded under pressure inside of a
female mandrel. The mandrel inside diameter may be sized so that a
pressurized balloon just contacts the inner wall of the mandrel.
Heat may be applied. Heat may cause the wall of the balloon to
soften and form against the inside of the female mandrel. This may
give the balloon a smoother outer layer and serve to tension the
fibers in the balloon.
[0432] FIG. 69 illustrates that a pleated balloon in an expanded or
inflated configuration can be substantially circular in
cross-section.
[0433] FIG. 70 illustrates that a balloon can be clamped in a
pleating tool 266 with two, three, four, five or more removable
pleating blocks 268. Heating the pleating blocks 268 to about 80
Celsius and then pressing them against the balloon for about 1
minute causes the balloon to become pleated or fluted. Commercial
pleating machines such as balloon folding machinery from Interface
Associates (Laguna Niguel, Calif.) can also be used. A small amount
of wax may be used to hold the pleated and folded balloon into its
desired shape.
[0434] FIG. 71 illustrates that a pleated balloon in a deflated or
contracted configuration can have one or more pleats.
[0435] Uni-tape layers can be their own layers.
[0436] FIG. 72 and FIG. 73 illustrate one method of uni-tape
fabrication. Tows or bands 270 provide the extruded monofilaments
or fibers 86 which are optionally passed through a treatment bath
272 to improve adhesive bonding features of the exterior of the
monofilaments via chemical etching, plasma arc etching or corona
discharge etching. The pretreated monofilaments from the tows are
pulled through an adhesive bath 274 over and under first rollers
232a where the matrix adhesive coats and surrounds the
monofilaments.
[0437] The adhesive-coated monofilaments are drawn through a fixed
gap rotary die 278. Release material 276 from second rollers 232b
can be applied to the top and bottom of the adhesive coated
monofilaments, for example, prior to the pulling of the tows 270
through the fixed gap rotary die 278 which controls adhesive
content and spreads the filaments. During a pull-trusion process,
the individual tows are laterally joined to form a uni-tape which
is heated by a heater 280 for viscosity change, after which the
tape is compacted via rolls third rollers 232c. The compacted tape
can then be passed over a chill plate 282 to the spool 244, with
the top sheet of release material being removed at roll fourth
roller 232d and reeled up on fifth roller 232e.
[0438] The monofilaments can be subject to less than about 0.02
pounds of tension during assembly substantially immediately before
the monofilaments set in the adhesive matrix. For example,
substantially no tensioning can be applied to the monofilaments
during manufacturing immediately before the monofilaments set in
the adhesive matrix.
[0439] Another kind of fiber tape (hereafter referred to as woven
tape) may have a woven, knitted or braided fiber cloth, a flexible
adhesive, and an optional removable backing or combinations
thereof. The removable backing can be made of paper, plastic, film,
metal, elastomer, foam, fabric or combinations thereof.
[0440] Woven, knitted and braided cloths are known though modern
textile products. Typically, weave patterns feature a warp threads,
running in a first direction, and weft threads, running in a second
direction. The angle between the first and second directions may be
90 degrees. The angle between the first and second directions may
be 75 degrees. The angle between the first and second directions
may be 60 degrees. The angle between the first and second
directions may be 45 degrees. The angle between the first and
second directions may be oriented at any appropriate angle. In the
process of weaving, the threads may be interlaced in various ways
to form weave patterns depending on the properties desired.
[0441] Another kind of fiber tape (hereafter referred to as matted
tape) can have matted fiber, a flexible adhesive, and an optional
removable backing or combinations thereof. The removable backing
can be made of paper, plastic, film, metal, elastomer, foam, fabric
or combinations thereof. The matted fiber may be a collection of
randomly oriented fibers of different lengths.
[0442] FIG. 74 shows that layers 72c and 72d can have reinforcement
fibers 86 oriented in the same direction. This is a 0-0
arrangement, because of the angle that each layer 72d makes with a
vector aligned with the fibers of the bottom layer 72c. This
arrangement may provide twice the strength in the fiber direction
as the uni-directional tape itself.
[0443] FIG. 75 shows that layers 72c and 72d can have reinforcement
fibers 86 oriented perpendicular to each other. This is a 0-90
arrangement, because of the angle that the second layer 72d makes
with a vector aligned with the fibers of the bottom layer 72c. This
arrangement may provide substantially the same strength in the 0
degree and 90 degree direction as the uni-directional tape
itself.
[0444] FIG. 76 shows that layers 72, 72d and 72e can have
reinforcement fibers 86 oriented at 0-0-90 to each other. This
arrangement may provide approximately twice the strength in the 0
direction than a single layer of uni-tape provides. This
arrangement may provide strength in the 90 direction approximately
equal to that of a single uni-tape.
[0445] FIG. 77 shows that layers 72c, 72d, 72e, 72f, 72g, and 72h
can be oriented at 0, 30, 60, 90, -30, -60 respectively to each
other.
[0446] A laminate may include one or more fiber tapes. A laminate
may include one or more polymer films.
[0447] The one or more fiber tapes and, optionally, the one or more
polymer films can be consolidated into a laminate. Consolidation
may include compaction and curing or melting. Compaction can occur
before curing or melting. Compaction may include the application of
heat and/or light and/or an electron beam, the application of force
(i.e., pressure), and the passage of time. Curing or melting may
include the application of heat or light, the application of force
(i.e., pressure), and the passage of time.
[0448] During the process of consolidation, fibers may shift
position within the laminate. During the process of consolidation,
the fibers may get closer to each other within the laminate.
[0449] The polymer film or polymer films may melt during the
consolidation process or the polymer films may not melt. The
polymer films can be on one or both outer surfaces of the laminate
and different materials can be put on each side. The polymer film
can be on only one side of the laminate, or absent altogether.
[0450] The polymer film could be formed by applying a polymer in a
wet application process, such as spraying, dipping, painting, or
combinations thereof.
[0451] The polymer film may be coated with a material. The coating
may be applied by, for instance, sputter coating. The material that
is coated on the polymer film may provide substantial
radiopacity.
[0452] FIG. 78 shows an example of the fabrication of a laminate by
using an auto clave. Various layers of fiber tape material 72c,
72d, and 72e can be between an outer layer 72a of a film and an
inner layer 72b of a film. The fiber tape material and the films
can be between a top vacuum sheet 238a and a bottom vacuum sheet.
The bottom vacuum sheet can be placed on a rigid plate or platen
288. Sealing is provided by seals 286. A breather material 284 may
be between the outer layer 72a and the top vacuum sheet 238a, for
example for evacuating gas from between the vacuum sheets. The
enclosed volume or bag between the top and bottom vacuum sheets can
be evacuated at the suction tube 242.
[0453] During the autoclave process as illustrated in FIG. 79, the
process steps are first to lay down the bottom vacuum sheet as
illustrated at 290. Secondly, one optionally lays down the inner
layer 292 to be laminated or consolidated as illustrated at 292,
followed by the peeling off of the removable backing and laying
down the first middle layer as illustrated at 294. Thereafter as
illustrated at 296, optional additional middle layers can be laid
down after removal of their removable backing. Additional fiber
tape can be laid down in additional directions as needed.
Thereafter, the outer layer can be optionally laid down as
illustrated at 298. A breather material 284 may be positioned
between the outer layer and the and top vacuum sheet. The top
vacuum sheet can be laid down over the breather material 284 as
illustrated at 300. The structure can be placed in an autoclave as
illustrated at 302. The volume between the bottom and top vacuum
sheets can be evacuated after sealing the edges as illustrated at
304.
[0454] Thereafter, as part of a consolidation phase, follows a
compaction phase as illustrated at 306 at the requisite pressures
and temperatures. Thereafter, as part of a consolidation phase,
follows a curing or melt phase as illustrated at 308 at associated
pressures and temperatures.
[0455] One set of pressures and temperatures useful for a
compaction or cure or melt phase is illustrated in FIG. 80 by the
temperature time graph and associated temperature pressure
graph.
[0456] Several laminates, each with different fiber orientations
and a different number of layers, may be created. Alternately, a
single laminate may be constructed with multiple fiber orientations
and layer quantities placed into different regions of the larger
laminate. From this single laminate, smaller laminates with
specific fiber orientations can then be removed and used to create
a medical inflatable.
[0457] The choice of a film for the inner or outer surface can
provide desirable properties.
[0458] If it is desired that the outside of the laminate be low
friction and resistant to harm from chemicals, or that the laminate
readily release from certain adhesives (such as, for instance,
Methyl methacrylate, a principal ingredient in bone cement), a
fluoropolymer such as FEP (Fluorinated ethylene propylene) may be
selected for the outer layer. One side or both sides of the FEP
film may be treated via a plasma method a corona discharge method
or via an etchant or by some combination thereof. These treatments
may make the flouropolymer film easily bondable on one or both of
its surfaces. The film may also be purchased in a bondable state. A
treated surface can form a strong bond with an adhesive, such as
the adhesive in the fiber matrix. A surface made bondable may be
restored to an unbondable state.
[0459] A metal film or foil layer on the outside of the balloon can
also be used to resist chemical attack. This metal film or foil
layer may give the balloon radiopacity. The outer surface of the
balloon may also have a coating that may help the balloon resist
chemical attack. The coating may be flouropolymer based.
[0460] The laminate can be made as describe in U.S. Pat. No.
5,333,568 or 5,470,632, both of which are herein incorporated by
reference in their entireties.
[0461] A layer may be leak tight. The layer may be made by dip
molding, for example, urethane or nylon, over a mandrel. The layer
may be made by rotational molding.
[0462] The layer may be made by coating a substance over the
mandrel or the balloon. A coating may be, for instance, parylene. A
coating may be a metal, such as gold. A coating may
electrodeposited, electroless deposited or via physical vapor
deposition or a combination thereof. A coating may have significant
radiopacity. A coating may increase the toughness of the balloon,
or increase its lubricity. A coating may reduce or eliminate attack
or adhesion from chemicals. For instance, a coating may cause the
balloon to not be attacked or to adhere to bone cement.
[0463] A layer may be formed by conformal coating. A conformal
coating may include a flouropolymer. The coating may be dipped on,
sprayed on or applied by electrostatically charging the substrate
or by combinations thereof. Coatings may be cured by baking.
[0464] A layer may be formed by blow molding. The blow molding
process can include a parison. The parision may be open at both
ends, or only open at one end (a "blind" parison).
[0465] FIG. 81A illustrates that the mandrel can have a spiral
groove. The fiber can be wound in the spiral groove. The spiral
groove can be on the proximal stem, proximal taper, constant
diameter section, distal taper, any steps, or combinations
thereof.
[0466] FIG. 81B illustrates that the mandrel groove 310 can be
stepped along the length of the mandrel. The fiber can be wound one
or more (as shown) times on each step of the groove 310.
[0467] FIG. 81C illustrates that the mandrel groove 310 can be
bound by groove edges 312 that can be raised above the level of
(i.e., have a larger radius than) the mandrel groove. The groove
edge 312 can interference fit against the fiber. The groove edge
height can be equal to or greater than the diameter of the
fiber.
[0468] FIG. 81D illustrates that the mandrel groove can be
configured to receive a second fiber having a second fiber
diameter. The second fiber can be wound into the second mandrel
groove. A first fiber having a first fiber diameter can be wound
between the windings of the mandrel groove. The second fiber can
act as a groove edge to the first fiber, interference fitting the
first fiber to trap the first fiber between windings of the second
fiber. The fibers can have a diameter of from about 0.0005 in. to
about 0.004 in. For example the first fiber can have a first fiber
diameter of about 0.00075 in. and the second fiber can have a
second fiber diameter of about 0.004 in.
[0469] FIG. 82A illustrates that a fiber tool 314 can be used to
configure the fiber into a spiral configuration. The fiber tool 314
can have a fiber tool first part 316a removably attached to a fiber
tool second part 316b. The fiber tool second part can have a tool
axle 322. The fiber tool first part can have a tool hub 320. The
tool axle 322 can be rotatably and/or removably received by the
tool hub 320.
[0470] The fiber tool 314 can form a fiber gap 318 between the
fiber tool first part 316a and the fiber tool second part 316b. The
fiber gap 318 can have a fiber gap width 324. The fiber gap 318 can
be adjusted by, for example, the use of a feeler gauge. The gap
width can be from about 15 .mu.m to about 200 .mu.m, more narrowly
from about 15 .mu.m to about 100 .mu.m, more narrowly from about 15
.mu.m to about 35 .mu.m. The fiber gap width 324 can be about, or
nominally larger than, the diameter of the fiber.
[0471] FIG. 82B illustrates that the fiber can be wound into the
fiber gap 318. The fiber gap can be straight, for example having a
circular configuration. A first release layer and a second release
layer may be placed on the inside walls of the fiber gap. An
adhesive may be placed in contact with the fiber. The adhesive may
be a thermoplastic or a thermoset. The adhesive may be cured or
melted. The adhesive may be in place before, during or after the
fiber is added to the fiber tool. The adhesive can be a resin. A
port (not shown) can be added to the tool such that, under
pressure, resin and/or solvent can be infused into the fiber in the
gap. The resin and/or solvent can extrude out the perimeter of the
gap. The gap can be sealed created a closed volume. The resin
and/or solvent can be delivered under pressure into the closed
volume of the gap to infuse the fiber.
[0472] FIG. 83 illustrates that after the adhesive is cured or
melted, the fiber tool first part can be removed from the fiber
tool second part. The wound fiber and adhesive, as shown, can then
be removed from the fiber tool. The wound fiber can have a
substantially flat or conical configuration.
[0473] FIG. 84 illustrates that the fiber gap can be v-shaped in
cross-section, for example having a conical configuration.
[0474] FIG. 85 illustrates the fiber and adhesive panel after
coming out the tool pictured in FIG. 84.
[0475] FIG. 86 illustrates that the wound fiber can be
pressure-formed on a mandrel.
[0476] FIG. 87 illustrates that the shape of the fiber can be
distorted by the mandrel to have a wall having a concave, convex or
s-curve.
[0477] Pressure forming may allow the conical panel to be formed
into a shape that more readily matches the shape of a portion of
the balloon. The resulting conical panel may be placed onto the
balloon and cured or melted into place.
[0478] FIG. 88 illustrates an alternate method of applying a fiber
tape to a balloon 20. The balloon 20 can have continuous laminates
that start at a first end of a mandrel, 230 go to the opposite end
of the mandrel 230 and return to the first end of a mandrel 230.
The laminate may start substantially at the first end of the
mandrel, 230 or near the first end, for example within 4 mm. The
balloon 20, the bladder or inner layer, or a mold can be
substituted for the mandrel 230 in this variation.
[0479] FIG. 89 illustrates that the mandrel can have one or more
cross channels 328 through the mandrel. The cross channels 328 can
have cross channel ports 330 on the surface of the mandrel. One or
more internal restraints can be placed through the mandrel. The
restraints may comprise a fiber. A continuous restraint may pass
thru one, some or all of the holes in the mandrel
[0480] FIG. 90 illustrates that the mandrel can have a cross
channels that can be parallel with one or more (shown as three)
adjacent cross channels. The cross-channels can be curved.
[0481] FIG. 91A illustrates that the cross-channel can transect the
diametric center of the mandrel. The cross-channel can be
straight.
[0482] FIG. 91B illustrates that the balloon can have an inner
layer and an outer layer. The internal restraint can be fixed to
the radial outside of the outer layer.
[0483] FIG. 91C illustrates that the internal restraint can be
fixed between the inner layer and the outer layer.
[0484] FIG. 91D illustrates that the internal restraint can be
fixed to the radial inside of the inner layer.
[0485] FIG. 92 illustrates a portion of an alternate process for
applying fiber tape to a mandrel. FIG. 92 illustrates that the
first, second, third and fourth strips 192a, 192b, 192c, and 192d
may have one or more layers of uni-tape oriented along the long
axis of the laminate (this fiber orientation is shown in the
figure). The strips 192 can be rectangular. The strips 192 can have
adhesive. Each strip may be oriented parallel to the mandrel
longitudinal axis or balloon longitudinal axis. Enough strips can
be used such that the strips encircle the mandrel's largest
diameter. The strips may overlap each other. The mandrel can have
one or more layers on the mandrel before the strips are
applied.
[0486] FIG. 93 illustrates that a panel may be applied to a mandrel
with none, one or more layers on the mandrel. The panel can have
one or more layers of uni-tape oriented along the long edge panel
longitudinal edge 332. The panel can have a panel width 334. The
panel can have a panel rectangular section 336 and one or more
panel serrations 338. The angle between the serrations 338 can be a
panel serration angle 340. The panel serration angle 340 can be
about 30.degree., about 20.degree., about 10.degree., or about
0.degree.. The panel longitudinal edge can be oriented parallel to
the mandrel longitudinal axis or the balloon longitudinal axis.
Parts of the panel may overlap other parts of the panel.
[0487] FIG. 94 illustrates that the panel can be applied to a
mandrel with none, one or more layers on the mandrel. The panel can
have one or more layers of uni-tape oriented perpendicular to the
panel longitudinal edge 332. The panel can have multiple layers of
uni-tape oriented at different angles in the panel (not shown). The
uni-tape may make angles (not shown) of about 30.degree., about
45.degree., or about 60.degree. with panel longitudinal edge
332.
[0488] The panel width can be more than about three times the
circumference of the balloon, layer or mandrel. The panel can be
wrapped around the balloon, layer or mandrel about three times. The
panel width can be more than about five times the circumference of
the balloon, layer or mandrel. The width can be more than about ten
times the circumference of the balloon, layer or mandrel.
[0489] FIG. 95 illustrates that a first panel 196a can have eight
serrations and a panel latitudinal edge 333. The first panel 196a
can be a laminate of resin and fiber, as described herein. A first
line 346a can be marked on the surface of the first panel 196a and
may be parallel to the latitudinal edge 333 and located about 3 mm
from the latitudinal edge 333. The first panel 196a can have a
panel bottom edge 344 and the panel longitudinal edge 332. The
panel bottom edge 344 can have a length of about 58 mm (2.3 in.).
The panel longitudinal edge 332 can have a length of about 50 mm in
length. The distance from the serration tip 342 to the first line
346a can be about 16 mm. The distance from the panel bottom edge
344 to the first line 346a can be about 47 mm. The second line 346b
can be marked on the surface of the panel. The second line 346b can
be perpendicular to first line 346a. The second line 346b can
intersect a serration tip 342. The second area 348b of the panel
below the first line 346a can have four unidirectional
reinforcement fiber tapes laid sequentially in the 0 degree
direction. The second area 348b can have two uni-tapes laid
sequentially in the 90 degree direction. The first area 348a of the
panel above the first line 346a can have two uni-tapes oriented
sequentially in the 0 degree direction and two uni-tapes oriented
sequentially in the 90 degree direction.
[0490] FIG. 96 illustrates that a second panel 196b can be
circular. The second panel 196b can be about 28 mm in diameter and
can have about four slits or cuts 350. Each cut 350 can be about 7
mm long. Four tabs 352 can be formed by the cuts 350. The second
panel can have one each of the uni-tapes oriented sequentially at
each of 0.degree., 30.degree., 60.degree., 90.degree., -30.degree.,
and -60.degree. angles.
[0491] FIG. 97 illustrates that a third panel 196c can be shaped
like a parallelogram with first side edge 356a parallel to second
side edge 356b and third side edge 356c parallel to fourth side
edge 356d. The first side edge 356a can form an acute angle with
third side edge 356c of about 70.degree.. The first side edge 356a
can be about 13 mm long. The third panel 196c can have one uni-tape
oriented in about the 0.degree. direction and one uni-tape oriented
in about the 90.degree. direction.
[0492] FIG. 98 illustrates that a fourth panel 196d can be
rectangular. The fourth panel 196d can have first and second long
edges 358a and 358c and first and second short edges 358b and 358d.
The long edges 358a and 358c can be about 58 mm. The short edges
358b and 358d can be about 3 mm long. The fourth panel can have
about three uni-tapes oriented sequentially in about the 0.degree.
direction and about one uni-tape oriented about in the 90.degree.
direction.
[0493] FIG. 99 illustrates that the fifth panel 196e can have panel
serrations 338 and a panel latitudinal edge 333. The first line
346a can be marked on the surface of the fifth panel 196e and may
be parallel to the latitudinal edge 333 and located about 8 mm from
latitudinal edge 333. The fifth panel can have a bottom edge 344
about 57 mm in length. The distance from the tip of the serrations
to the dotted line can be about 7 mm. The distance from the bottom
edge to the dotted line can be about 43 mm. The second area 348b of
the panel below the first line 346a may have four uni-tapes
oriented sequentially in the 0.degree. direction and two uni-tapes
oriented sequentially in the 90.degree. direction. The first area
348a of the panel above the first line can have two uni-tapes
oriented sequentially in the 0.degree. direction and two uni-tapes
oriented sequentially in the 90.degree. direction.
[0494] FIG. 100 illustrates that the sixth panel 196f can have a
circular edge 360 with a radius of curvature of about 20 mm. The
sixth panel 196f can have panel first and second radial edges 362a
and 362b that connect to the panel circular edge 360 and connect to
the center of the radius of curvature of the panel circular edge
360. The sixth panel can have one each of the uni-tapes oriented
sequentially at each of 0.degree., 30.degree., 60.degree.,
90.degree., -30.degree., and -60.degree. with respect to each
other.
[0495] FIG. 101 illustrates that the mandrel 230 can have a mandrel
constant diameter section 370 of about 17.07 mm in diameter and
about 76 mm in length. The mandrel 230 can have a mandrel
transition 366 where the first constant diameter section meets the
distal taper approaching the mandrel terminal distal end 372. The
mandrel 230 can have a mandrel stem 364 and mandrel proximal taper
368. The mandrel 230 can have mandrel transition 366 where the
proximal taper 368 meets the mandrel constant diameter section 370.
The mandrel 230 can have a mandrel transition 366 where the radius
stem 416 meets transition radius. The mandrel can have transitions
366 between lengths.
[0496] FIG. 102 illustrates that the first panel 196a can be
wrapped around the distal end of the mandrel 230. The first line
346a can be aligned with mandrel transition 366 at the distal end
of the mandrel 366. Adhesive can be placed in the region of overlap
seam 66 to secure the panel on the mandrel. The adhesive can hold
the panel closed around the mandrel. Standard cellophane tape 374
(also element 343) can secure the panel to the mandrel. Adhesive
may next be applied to completely cover the outer surface of the
serrations. Every other serration can be first folded over the
mandrel distal taper. The remaining serrations can then be folded
onto the mandrel distal taper.
[0497] FIG. 103 illustrates the mandrel 230 with the first panel
196a applied to the mandrel 230 as described infra and in FIG.
73.
[0498] FIG. 104 illustrates that the second panel 196b can be
centered on top of the distal taper. Any cut 350 in the panel can
be aligned with the second line 346b on the first panel 356a. The
four tabs 352 of the second panel can be folded over the serrations
338.
[0499] FIG. 105 illustrates the mandrel with the first and second
panels 196a and 356b applied to the mandrel as described
herein.
[0500] FIG. 106 illustrates that the fourth panel 196d can have
adhesive applied to one surface. Second long edge 358c of the
fourth panel 196d can be aligned with the first line 346a on the
first panel 196a. The first long edge 358a can be positioned
proximal to the first line 346a. The fourth panel 196d can be
wrapped around the mandrel, with the adhesive on the fourth panel
facing toward the mandrel. The balloon second section 384b can be
removed from the mandrel.
[0501] FIG. 107 illustrates that the balloon second section 384b.
The distal balloon fragment can have balloon outer diameter 50.
[0502] FIG. 108A illustrates that the female mold 376 can be made
of a first mold half 378a and a second mold half 378b. When the two
mold halves 378a and 378b are brought together, they can form a
center mold lumen 380 where the second balloon section 384b may be
placed in the mold 376. A mold port 382 in mold second half 378b is
in fluid communication with the mold lumen 380. The mold port 382
can be used to connect a vacuum pump when curing a balloon
fragment. The balloon fragment 384 can be placed in the mold lumen
380.
[0503] FIG. 108B illustrates that an optional first releaser 236a
can be applied to the inside of the female mold 376. The first
releaser 236a can be a grease, a non-stick film or a non-stick tape
or sheet. A second releaser 236b can be placed on top of the
balloon fragment 384. This second mold releaser or release agent
can be a grease or a non-stick film. A breather material 284 can
next be placed for purposes of equalizing the pressure during a
curing cycle. A vacuum bag or top vacuum sheet and a seal can be
installed. The mold port can forms a fluid connection from outside
the mold to the space between the vacuum bag or top vacuum sheet
and the inner wall of the female mold. This fluid connection can
remain unobstructed by the first mold releaser or release agent,
balloon fragment 384, second mold release agent, and breather
material 284, when a vacuum pressure is applied to the mold port.
The distal balloon fragment 384 may be consolidated.
[0504] FIG. 109 illustrates that the third panel 196c can be coated
on one side with adhesive. The third panel 196c may be wrapped
around the mandrel stem with the adhesive side facing away from the
mandrel stem. The third panel 196c can be wrapped such that the
fourth side edge 356d is approximately coincident with the mandrel
transition from the mandrel stem to the mandrel proximal taper.
[0505] FIG. 110 illustrates that the fifth panel 196e can be
wrapped around the proximal end of the mandrel. The serrations can
point in the proximal direction. The first line 346a may be aligned
about 7 mm proximal to the transition between the mandrel proximal
taper and the mandrel constant diameter section. The first line
346a can be aligned parallel to the mandrel transition. Adhesive
can be applied on the panel where the panel overlaps with itself.
Adhesive can be applied to completely cover the surface of the
serrations that face out from the mandrel. Every other serration
may first folded over the proximal taper. Then the remaining
serrations may be folded onto the cone.
[0506] FIG. 111 illustrates that the sixth panel 196f may be
wrapped over the proximal taper. the sixth panel, when wrapped
around the proximal taper can cover more than about 2 mm of the
mandrel stem and more than about 2 mm of the mandrel constant
diameter section.
[0507] FIG. 112 illustrates that the balloon first and second
sections 384a and 384b can be slid together such that they overlap
by about 6 mm. An adhesive can be placed in the overlap region or
seam. The first and second balloons sections and adhesive may be
placed in a female mold. A compliant balloon or bladder may be
inserted inside the balloon fragments. The balloon may be
consolidated to form a fiber reinforced balloon, 10 and 20, capable
of sustaining pressure.
[0508] FIG. 113 illustrates that a second balloon fragment 284b
that can have the third, fifth and sixth panels 196c, 196e, and
196f combined. The proximal balloon fragment may be placed under
vacuum in a female mold and consolidated.
[0509] The longitudinal length 388 of the constant diameter section
of second balloon section 384b can be trimmed to about 9 mm
long.
[0510] FIG. 114 illustrates that a solid release film (not shown)
such as Teflon may be inserted into the interior of the balloon.
The first and second balloon sections 384a and 384b can be clamped
together by clamps 386. The balloon sections 384 can be
consolidated to form a fiber reinforced balloon 20 capable of
sustaining pressure.
[0511] Additional laminates can be added to areas of a balloon that
might require extra strength for certain procedures or uses. A
balloon may have different amounts of fiber, adhesive or polymer
film in different portions of the balloon wall. A balloon may have
different number of fiber layers in different portions of the
balloon wall.
[0512] FIG. 115 illustrates a variation of the assembled
device.
[0513] FIG. 116 illustrates that a first panel of polymer can rest
on top of the female mold half (The first panel can be a
see-through polymer for illustrative purposes, for example the
contours of the mold may be seen.) The first panel can be a
polymer, such as a nylon, PET, polycarbonate, urethane or any other
polymer that can be readily formed. The first panel be about 0.002
inches thick, more narrowly about 0.001 inches thick, yet more
narrowly about 0.0005 inches thick.
[0514] FIG. 117 illustrates that the first panel can be formed to
the contours of mold.
[0515] FIG. 118 illustrates that the first panel can be lifted free
of the mold. The first panel can have a panel flat 390 that did not
enter the form of the female mold during forming. The panel can be
trimmed, for example in a trimming jig.
[0516] FIG. 119 illustrates that first and second panels can have
their flats 390 trimmed. The two panels can be closed tightly
around a mandrel and a mandrel shaft 392. The panels can then be
bonded to each other at the point where they overlap. The bond may
connect all or some of the material that overlaps. The bond may be
leak tight to the passage or air and water. Bonding may take place
by addition of an adhesive, by the application of heat, by the
application of ultrasonic energy, by use of a laser, by the
application of radio frequency energy, by the application of
pressure or by combinations thereof. A material may be added to the
joint that enhances the effectiveness of these bonding
techniques.
[0517] FIG. 120 illustrates that inner layer may be constructed
over a mandrel which is not removable. The inner layer can be
constructed inside a female mold (not shown) that matches the
intended outer shape of the inner layer. Both a mandrel and a
female mold may be used together to create a narrow thickness for
the inner layer to be formed in. The inner layer may be
thermoformed, or injection molded or constructed via some other
method listed supra. The inner layer can be slit 394, removed from
the non-removable mandrel and placed over a removable mandrel (as
described above). The slit 394 can then be patched with a thin
strip of polymer attached to inner layer.
[0518] An inner layer may be formed by a standard blow molding
process such as extrusion blow molding, injection blow molding, or
stretch blow molding. The inner layer may be checked for leaks
before being used.
[0519] FIG. 121 illustrates that a strip 192 can be an elongated
element of polymer film, metal foil or fiber tape cut into a shape
that may be useful in creating a fiber reinforced balloon. The
shape of the strip 192 may be cut by hand, with a high pressure
water jet or with a laser. Extending longitudinally from a first
end of the strip 192 to a second end of the strip 192, the strip
192 can have a first narrow section 396a, a first taper, a first
wide section 398a, a first central narrowing, a circular section
402, a second central narrowing, a second wide section 398b, a
second taper, and a second narrow section 396b. The strip can have
one or more reinforcement fibers. The reinforcement fibers can be
substantially aligned with the strip longitudinal axis. For
example, the strip 192 can have uni-tape. The strip 192 can have
one or more layers. The reinforcement fibers can extend the entire
length of the strip 192. A polymer film (not shown) can on one side
or both sides of the strip 192. The strip 192 can be flexible
before and after consolidation.
[0520] FIG. 122 illustrates that fibers in strip 192 can be
uni-directional and can be substantially aligned with the strip
longitudinal axis. The strip can be substantially rectangular. A
polymer film (not shown) can be placed on one side or both sides of
the strip 192. The strip 192 can be flexible before and after
consolidation.
[0521] FIG. 123 illustrates that a first, second and third strip
192a, 192b, and 192c can be aligned at equal strip angles 404 to
each other to form a rosette. The strip angle 404 can be the angle
from the first strip longitudinal axis to the adjacent strip
longitudinal axis. The circular section 402 for each strip 192 can
be substantially concentric to the circular sections for the other
strips 192.
[0522] FIG. 124 illustrates that the strips 192 can have no
reinforcement fibers.
[0523] FIG. 125 illustrates that strip can be applied to the inner
layer (e.g., bladder). The inner layer can have a hard mandrel
inside of the inner layer. The mandrel can support the surface of
the inner layer. The circular section 402 of the strip can be
concentrically aligned with the terminal distal end of the inner
layer and adhered in place. The remainder of strip can be laid over
the contours of inner layer or bladder such that narrow sections of
fiber tape partially cover stem on bladder.
[0524] Several pieces of fiber tape may be applied to bladder. Each
piece may be concentrically aligned with the tip of the distal end
of the bladder and adhered in place. However, alignment may be such
that the fiber tape cover sections of bladder and shaft that have
not yet been covered with fiber tape or have not yet been covered
with fiber tape with fibers in substantially similar orientations.
Two to eight pieces of fiber tape may be applied in this manner.
Application may continue until all of bladder 72b is covered in
fiber tape with fibers substantially oriented along the long axis
of the mandrel and stem.
[0525] FIG. 126 illustrates that fiber tape may be applied to a
flexible bladder or inner layer. The bladder can be supported by
the presence of mandrel inside of it. Fiber tape may be wrapped
from two to eight times around the largest diameter of the bladder.
FIG. 210 shows fiber tape wrapping more than three and less than
four times around bladder. At the end of this wrapping procedure,
fiber tape may be tightly wrapped around the largest diameter of
mandrel.
[0526] FIG. 127 illustrates that fiber may be wound around flexible
bladder or inner layer. Bladder may be supported by the presence of
mandrel inside of it. Fiber 86 may be uni-directional fibers with
or without adhesive. Fiber may be a continuous piece of fiber.
Fiber 86 may be wrapped over a portion or all of bladder. Adhesive
may be applied to bladder 72 before application of the fiber,
during application of the fiber or after application of the fiber
or some combination thereof.
[0527] Successive layers of fiber may be used to build a completed
balloon. Three pieces of fiber tape may be applied to bladder 72.
This may be followed by the application of fiber tape substantially
over the main diameter. This may be followed by application of
fiber 86 on a portion or all of the proximal taper and stem of the
bladder. This may be followed by application of fiber 86 on a
portion or all of the distal tip of the bladder. Lastly, a layer of
PEN film may be applied. Layers of fiber tape or fiber may be
omitted from this sequence. Layers of fiber tape and fiber can be
applied in any order. Polymer film may be applied between layers,
over the bladder or over the final layer of fiber or fiber
tape.
[0528] FIGS. 128A and 128B illustrate that the unconsolidated
balloon may be placed in a female mold 376. The unconsolidated
balloon can include the shaft 2000, mandrel 230, bladder 72 and the
various layers of fiber, fiber tape and film. The female mold 376
may contain a pocket for the unconsolidated balloon that is
slightly larger than the unconsolidated balloon.
[0529] FIG. 128C illustrates that the lower portion of FIG. 104 is
a portion of mandrel 230 and the upper portion of FIG. 104 is a
portion of female mold 376. The various layers of fiber, fiber tape
and film can be spaced from the surface of the mold 376. This
distance may be from about 0.005 in. to about 0.050 in. When the
bladder 72 is inflated, the layers 72 can detach from the mandrel
230 and press firmly against the walls of the female mold 376.
[0530] FIG. 128C shows the layers after detaching from mandrel 230
but before being pressed against female mold 376. This inflation
and expansion may serve to straighten and/or tension the fibers.
Heat or light or an electron beam or a combination thereof may be
used with the inflation of bladder 72b and the passage of time to
consolidate a fiber reinforced balloon. Light or an electron beam
may be applied, as part of a consolidation, by inserting a source
within a hollow lumen in a mandrel. The mandrel can then be removed
as described infra.
Method of Use
[0531] The device 2, for example including the balloon 20, can be
used for Kyphoplasty, angioplasty including CTO dilation, stent
delivery, sinuplasty, valvuloplasty, drug or other fluid delivery
through the balloon, radiopaque marking, incising the inside of a
vessel (e.g., to open or expand a vessel), brachytherapy,
intentionally obstruct a vessel, or combinations thereof. The
device 2 can be used to deliver one or more stents and/valves
and/or emboli filters to the coronary blood vessels (e.g., arteries
or veins), carotid artery, peripheral blood vessels, the GI tract,
the biliary ducts, the urinary tract, the gynecologic tract, and
combinations thereof. The device 2 can be used to prepare a cardiac
annulus and/or the leaflets of a natural heart valve for open or
percutaneous (minimally invasive) valve replacement. The device 2
can expand and deploy a percutaneously delivered heart valve
[0532] FIG. 129 illustrates a sagittal view of a patient and the
spine 406. The spine 406 can have vertebrae 408 and cervical,
thoracic, lumbar and sacral regions 410, 412, 414, and 416. The
device 2 can be used in or between vertebrae 408 in any region of
the spine 406.
[0533] FIG. 130 illustrates a vertebrae 408 that can have cortical
bone 418 and cancellous bone 420. The vertebrae 408 can have a
vertebral body 422 a vertebral process 424 and pedicles 426.
[0534] FIG. 131 illustrates a vertebra that a delivery tube 428,
such as a cannula, can be inserted against or into the pedicle. The
delivery tube 428 may have a inside diameter of less than about 6
mm, more narrowly from about 2 mm to about 4.5 mm. A bone drill can
be passed through the delivery tube 428 to drill to create a drill
void 430 in the cancellous bone. The bone drill can then be removed
leaving the drill void 430 in the cancellous bone.
[0535] FIG. 132 illustrates a cross section of a balloon 20. The
balloon 20 can be in a substantially inflated condition. The cross
section area is shown. The balloon wall can have a balloon wall
area 432.
[0536] FIG. 133 illustrates a cross section of balloon 20 in a
substantially deflated and folded configuration. The balloon 20 is
shown in a delivery tube or cannula with a delivery tube inside
diameter 436 and a delivery tube area 434. The balloon 20 may be
able to slide in the cannula.
[0537] The compression ratio of the balloon can be from about 3:1
to about 6:1, more narrowly from about 4:1 to about 5:1. The
compression ratio can be the ratio between the outside diameter of
the substantially inflated balloon (e.g., as shown in FIG. 132) and
the inside diameter of the delivery tube (e.g., the cannula as
shown in FIG. 133).
[0538] The balloon can have a packing density equal to or greater
than about 40%, more narrowly greater than or equal to about 55%,
yet more narrowly equal to or greater than about 70%. The packing
density can be the percentage ratio between the cross sectional
area of the walls of the balloon and the cross sectional area of
the inside of the cannula.
[0539] The packing density and compression ratios for the balloon
can remain substantially constant and the wall strength of the
balloon can remain substantially constant with repeated packing and
unpackings, and/or compressings and uncompressings.
[0540] The balloon can be folded into the cannula and expanded
about eight times while not significantly degrading the strength of
the balloon wall.
[0541] FIG. 134 illustrates that the balloon can be inserted, as
shown by arrow, through the delivery tube and into the drill void
in the cancellous bone.
[0542] FIG. 135 illustrates that fluid pressure can be delivered,
as shown by arrow 438, through the hollow shaft 2000 to the balloon
20. The balloon 20 can inflate and expand, as shown by arrows 440.
The expanding balloon can compress the cancellous bone surrounding
the drill void, creating a larger balloon void 442. The balloon 20
can be deflated and contracted. The balloon can be removed from the
vertebral body and the delivery tube.
[0543] FIG. 136 illustrates that the diametric elasticity of
existing medical inflatable devices can be approximately 0.06
in./ATM and a typical burst pressure is about 3 ATM. The medical
inflatable device 2 can have an exemplary diametric elasticity of
0.0004 in./ATM and a burst pressure above 20 ATM (290 psi). For
example, the burst pressure can be from about 290 psi to about 1500
psi. More narrowly, the burst pressure can be from about 500 psi to
about 1000 psi. For example, the burst pressure can be about 500
psi, about 750 psi, about 1000 psi, about 1500 psi, or higher than
1500 psi. For example, the burst pressure can be greater than 4 ATM
with a diameter of greater than 20 mm, with a diametric compliance
of less than about 15%, or less than about 10% or less than 5%.
[0544] FIG. 137 illustrates that a hollow balloon void 442 can be
formed within the cancellous bone of the vertebral body. The
balloon void 442 can remain in place when the balloon 20 is
withdrawn from the vertebral body.
[0545] FIG. 138 illustrates that a cement conduit 444 can be
inserted, as shown by arrow 446, through the delivery tube and into
the balloon void. A filler, such as a bone cement 445, can be
inserted, as shown by arrow 448, into the balloon void 442.
[0546] FIG. 139 illustrates that additional bone cement 445 can be
delivered through the cement conduit 444 to the balloon void
442.
[0547] FIG. 140 illustrates that the balloon void can be
substantially filled with the bone cement. The bone cement can
cure. The cement conduit can be removed. The delivery tube can be
removed.
[0548] FIGS. 141A through 141C illustrate a method of creating an
initial balloon void with a first balloon similar to the methods
shown herein. The first balloon 20a can create an initial balloon
void 442a in the cancellous bone.
[0549] FIG. 141D illustrates that the pressure can be removed, as
shown by arrow 450, and/or suction can be applied through the first
hollow shaft. The first balloon 20a can deflate and contract, as
shown by arrows 452. The first balloon 20a can be left in the
initial balloon void. The first hollow shaft can be pushed to the
side of the delivery tube.
[0550] FIG. 141E illustrates that a second balloon attached to a
second hollow tube can be inserted, as shown by arrow, through the
delivery tube 428 and into the initial balloon void 442a. The
second balloon can be placed adjacent to the first balloon.
[0551] FIG. 141F illustrates that a first pressure can be
delivered, as shown by arrow 438a, through the first hollow shaft
and into the first balloon. The first balloon can undergo a first
balloon final expansion, as shown by arrows 440a. Before,
concurrent with, or subsequent to the first balloon final
expansion, a second pressure can be delivered, as shown by arrow
438b, through the second hollow shaft and into the second balloon
20b. The second balloon can undergo a second balloon expansion, as
shown by arrows 440b. The first balloon final expansion and the
second balloon expansion can create a final balloon void 442b in
the cancellous bone.
[0552] FIG. 141G illustrates that the first and second balloons can
be deflated, contracted and removed from the final balloon void
442b. The final balloon void can remain in place with the balloons
removed. The final balloon void can be larger than the initial
balloon void.
[0553] FIG. 141H illustrates that a cement conduit can be inserted,
as shown by arrow, through the delivery tube and into the balloon
void. A filler, such as a bone cement, can be inserted into the
final balloon void.
[0554] FIG. 141i illustrates that the final balloon void can be
substantially filled with the bone cement. The bone cement can
cure. The cement conduit can be removed. The delivery tube can be
removed.
[0555] FIGS. 142A through 142C illustrate a method of created a
balloon void with a balloon similar to the methods shown herein.
The hollow shaft can be attached to a cement conduit.
[0556] FIG. 142D illustrates that the bone cement can be delivered
through the cement conduit and into the balloon void. The balloon
can be deflated and contracted, as shown by arrows, and/or the
balloon can be pushed out of the way by pressurized bone cement
delivered into the balloon void. The bone cement can contact the
balloon with or without significantly decaying, eroding or bonding
to the balloon wall.
[0557] FIG. 142E illustrates that additional bone cement can be
delivered to the balloon void as the balloon contracts. The bone
cement can partially or completely cure with our without being in
contact with the balloon. The balloon wall can peel away or
otherwise be separated from cured or uncured bone cement.
[0558] FIG. 142F illustrates that the final balloon void can be
substantially filled with the bone cement. The bone cement can
cure. The hollow shaft and cement conduit can be removed. The
delivery tube can be removed.
[0559] FIGS. 131 through 142F illustrate that the one or more
balloons can be inserted into the vertebral body unilaterally,
through a pedicle on one lateral side of the vertebra.
[0560] FIGS. 143A through 143i illustrate a method for deploying
the balloons bilaterally, for example including one balloon
inserted through each of opposing pedicles 426a and 426b.
[0561] FIG. 143A illustrates that a first delivery guide 428a can
be through the left pedicle 426a. A first drill void 430a can be
formed on the left side of the vertebral body. A second delivery
guide 428b can be through the right pedicle 426b. A second drill
void 430b can be formed on the left side of the vertebral body.
[0562] FIG. 143B illustrates that a first balloon 20a can be
inserted into the left side of the vertebral body through the first
delivery tube 428a. A second balloon 20b can be inserted into the
right side of the vertebral body through the second delivery tube
428b.
[0563] FIG. 143C illustrates that the first balloon 20a can be
inserted through the first delivery tube 428a. The second balloon
20b can be inserted through the second delivery tube 428b. The
first and second balloons can be inflated and expanded. The first
and second balloons can form a first void segment 454a and a second
void segment 454b, respectively, of the balloon void 442. The void
segments 454 may overlap, as shown. The void segments 454 may be
separate.
[0564] FIG. 143D illustrates that the second balloon can be
deflated, contracted and removed from the balloon void.
[0565] FIG. 143E illustrates that a second cement conduit can be
inserted through the second delivery tube and into the second void
segment. Bone cement can be delivered through the second cement
conduit and into the second void segment.
[0566] FIG. 143F illustrates that the bone cement can fill the
second void segment and/or contact the first balloon. The second
cement conduit can be removed from the balloon void. The bone
cement delivered to the second void segment can cure. The first
balloon may not erode, decay or bond to the cement.
[0567] FIG. 143G illustrates that the first balloon can be
deflated, contracted and withdrawn from the first void segment. The
first void segment can be empty. The second void segment can be
substantially filled with bone cement.
[0568] FIG. 143H illustrates that a first cement conduit can be
inserted through the first delivery tube and into the first void
segment. Bone cement can be delivered through the first cement
conduit and into the first void segment.
[0569] FIG. 143i illustrates that the first and second delivery
tubes can be removed from the patient. The balloon void can be
substantially filled with bone cement.
[0570] FIG. 144 illustrates that a guide block 456 may have a
surface block top surface 458a and a block bottom surface 458b. The
block can have finger depressions 460 where a user's fingers may
grip the block. The block 456 can have a curved block channel 464
passing though the block 456. The block channel 464 can terminate
at a block top hole 462a and a block bottom hole 462b. The block
456 can have one, two, or three radiopaque markers 466 evenly or
unevenly distributed about the block 456. The radiopaque markers
466 can have a fixed dimensional relationship to block bottom hole
462b.
[0571] The block can be partially or total radiolucent. The block
top surface can be placed against a patient's back before a
kyphoplasty procedure. The radiopaque markers can locate the block
with respect to the patient anatomy. The block bottom hole can be
located on the patient's back during use.
[0572] FIG. 145 illustrates that an entry tool, such as a trocar
469 and a delivery tube, such as a cannula 468, may have curvatures
that substantially match the curvature of the block channel. The
cannula 468 can slide freely in the block channel. The cannula can
be lubricated on the outside diameter. The block top hole may be
lubricated on the inside diameter. By holding block in place on the
patient's anatomy, a medical practitioner may be able to advance
the trocar and the cannula into a vertebral body along a curved
arc.
[0573] FIG. 146 illustrates that the cannula and trocar may advance
further though the block. The trocar can be a torsion shaft with a
drill bit on the distal end. Turning the torsion shaft can cause
the drill to bore into bone while being guided in a curved path by
the cannula.
[0574] The cannula can be a flexible tube or series of links. The
cannula, for example as a tube, or series of links, may be
steerable, for example similar to a catheter or an endoscope.
[0575] FIG. 147 illustrates that the inflation system 470 can be
attachable to a syringe 472 or other source of flow and pressure.
The inflation system 470 can include part or all of the hollow
shaft 2000, an inner shaft 477a, a stiffening shaft 476, a hollow
shaft lumen 154, a stiffening shaft lumen 478, an inflation port
482 and a stiffening rod control 480. The distal end of the
stiffening shaft 476 can have a stiffening rod tip 484.
[0576] The syringe 472 can be detachable or non-detachable from the
remainder of the inflation system 470. The balloon 20 may be
inflated by pushing inflation fluid, such as water or dye, from the
syringe 472, into the inflation port 482, through the hollow shaft
lumen 154 and into the balloon 20. The removable stiffening shaft
476 may be left in place to stiffen the inflation system 470 while
positioning the balloon 20 in the body. Once the balloon 20 is in
place, the removable shaft stiffener 476 can be removed to allow
the hollow shaft 2000 additional freedom of motion outside the
body.
[0577] The stiffening shaft 476 can be integral with or removably
attached to the stiffening rod 474. The stiffening rod tip 484 can
have atraumatic geometry, or a soft plastic or elastomeric tip that
will minimize puncture or damage the distal end of the balloon. The
stiffener 476 can be withdrawn manually automatically.
[0578] FIG. 148 illustrates that the inflation system 470 can have
a balloon 20 that can be inflated by pushing inflation fluid, such
as water, saline, a gel or dye, from the syringe 472, into the
inflation port 482, though the hollow shaft lumen 154 and into the
balloon 20.
[0579] The stiffening rod 474 can be removed from the inflation
system or left in place to stiffen the inflation system 470 while
positioning the balloon 20 in the body. The inflation system can
have a stiffening rod control 480, for example a knob or handle on
the proximal end of the inflation system to control the position of
the stiffening rod. A seal adjacent to the stiffening rod control
can prevent pressure from escaping from the hollow shaft lumen.
When the balloon 20 is at the target site, the stiffening rod 474
can be removed from the inflation system or left in place.
[0580] FIG. 149 illustrates that the stiffening rod control 480 can
have inner threads 486b. A connector at the proximal end of the
hollow shaft 2000 can have outer threads 486a. The stiffening rod
control 480 can rotatably interface with the hollow shaft 2000 at
the inner and outer threads 486b and 486a.
[0581] The stiffening rod 474 can be attached to the inside of the
distal end of the balloon 20. The stiffening rod can have a
coupling (not shown) internal to the rod that can prevent the rod
from applying torque to the balloon 20. The stiffening rod can be
made from flexible high strength filaments (not shown). The balloon
20 may be inflated by pushing inflation fluid, such as water or
dye, from the syringe 472, into an inflation port, though the
hollow shaft lumen or inflation lumen and into the balloon. Turning
the stiffening rod control knob may cause the balloon to
longitudinally expand or contract. The balloon can evert when the
stiffening rod is withdrawn proximally. The balloon's distal end
may resemble the distal end 44 shown in FIG. 10d.
[0582] FIG. 150A illustrates that the first balloon 20a can be
inserted into the body through a working channel or delivery tube
such as the cannula 468. The first balloon 20a in a deflated
configuration can be smaller in diameter than the cannula inner
diameter 488. The hollow shaft 2000 can have a hollow shaft outer
diameter 490. The hollow shaft outer diameter 490 can be smaller
than the cannula inner diameter 488. For example, the cannula inner
diameter can be about 3.66 mm (0.144 in.). The hollow shaft outer
diameter can be about 2 mm (0.09 in.), more narrowly about 1.5 mm
(0.060 in.), yet more narrowly about 0.8 mm (0.03 in.). The
stiffening rod can have a stiffener rod diameter. The stiffener rod
can have a stiffening rod diameter 492. The stiffener rod diameter
can be about 1 mm (0.05 in.), or about 0.8 mm (0.03 in.), or about
0.5 mm (0.02 in.).
[0583] The first balloon 20a can be inflated in the body, for
example creating a first balloon void, lumen or pocket in the body.
The first balloon 20a can be inflated in bone. The first balloon
20a can be inflated in a vertebra of the spine. The first balloon
20a can then be deflated and pushed to the side of the cannula
468.
[0584] FIG. 150B illustrates that a second balloon 20b can be
inserted through the hollow shaft 2000 while the first balloon 20a
is positioned through the hollow shaft 2000. The first balloon 20a
and the second balloon 20b can be inserted concurrently through the
hollow shaft 2000. The first balloon 20a can be deflated before the
second balloon 20b is inflated.
[0585] FIG. 150C illustrates that the first balloon 20a and the
second balloon 20b can be inserted into the initial void 442a
created by a drill and/or the first balloon 20a. The first balloon
20a and the second balloon 20b can be inflated in the initial void
42a. The balloons 20 can create a final balloon void 442b, for
example the final balloon void 442b can be larger than the initial
balloon void 442a. Additional balloons can be inserted into the
void 442 and inflated to further enlarge the balloon void 442.
[0586] FIG. 151A illustrates that an inflation system 470 and the
device 2 can create space in the body. The balloon 20 can be
substantially compliant or substantially non-compliant. The hollow
shaft 2000 can be attached to or integrated with the inflation
system 470.
[0587] The inflation system 470 can be portable and can be held in
and operated by the user's hand. The inflation system 470 can
provide a method for inflating the balloon 20. The inflation system
470 can advance and retract the stiffening rod to stiffen the
balloon 20 during insertion of the balloon 20 into the body. The
hollow shaft 2000 can have an inflation lumen between the inflation
system and the balloon 20.
[0588] FIG. 151B illustrates that the inflation system 470 can have
a pressure delivery body 498, and a pressure control 494 (also
element 590) attached to the pressure delivery body 498. The
pressure control 494 can regulate the inflation of the balloon 20.
The inflation system 470 can have a stiffening rod control 480. The
stiffening rod control 480 can manipulate a stiffening rod 474 in
the hollow shaft 2000. For example, the stiffening rod 474 can be
advanced through or retracted from the hollow shaft 2000. The
stiffening rod control 480 and/or the pressure control 494 can have
buttons, knobs, or combinations thereof. The stiffening rod control
480 can be used to regulate the inflation of the balloon 20. A
pressure gauge 496 attached to the lumen can show the pressure in
balloon 20.
[0589] FIG. 151C illustrates that a pressure control interface 502
can interface the pressure delivery body 498 with the pressure
control 494. The pressure control interface 502 can be mating
threads. The pressure control interface 502 can have male threads
on the pressure control 494 that can mate to female threads on the
pressure delivery body 498. Manipulating, such as turning, the
pressure control interface 502, can increase or decrease the
pre-load volume. When the pressure control 494 closes on the
pre-load volume 504, the fluid in the pre-load volume 504 can exit
through the pressure delivery body port 506 (also element 592). The
fluid in the pre-load volume 504 can have a water or a radiopaque
dye.
[0590] The stiffening rod control 480 can have a stiffening rod
control interface 500 can mate the stiffening rod control 480 with
the pressure delivery body 498. The stiffening rod control
interface 500 can have mating threads. Turning the stiffening rod
control 480 can extend and retract the stiffening rod 474.
[0591] The pressure control interface 502 can have male threads on
the pressure control 494 that can mate to female threads on the
pressure delivery body 498. The pressure control 494 and/or the
stiffening rod control 480 can have one or more pressure tight
seals to prevent leakage through the control.
[0592] FIG. 151C illustrates that the stiffening rod can block the
pressure delivery body port 506 when the stiffening rod is in a
longitudinally advanced position.
[0593] The o-ring seats 226 can seat o-rings that can seal against
the pressure delivery body 498. The seals 286 in o-ring seats 226
can form a pressurized volume between themselves that connects to
the pressure delivery body port 506 and the input of pressure gauge
496 (as shown in FIGS. 151C and 151D). The seals 286 in the o-ring
seats 226 can form a pressurized volume that does not always
connect to the inflation lumen 154. The inflation lumen 154 can
connect to the internal volume of balloon 20.
[0594] FIG. 151C illustrates that retracting the stiffening rod
control 414 (e.g., unscrewing the stiffening rod control 414) can
cause the pressurized volume between seals 286 in o-ring seats 226
to no longer be in fluid communication with the inflation lumen,
and/or the pressure delivery body port and/or the input of the
pressure gauge 496. The stiffening rod control 480 (by, for
example, rotating it) may cause the pressure delivery body port 506
and the input of pressure gauge 496 to be connected to the
inflation lumen 154 that leads to balloon 20. Manipulating the
pressure control 494 can cause fluid to flow though the pressure
delivery body port 506, through the inflation lumen 154 and into
the balloon 20, inflating the balloon 20.
[0595] The distal end of the device 2, for example the balloon 20,
can be inserted into the body though a cannula. The stiffening rod
control can be manipulated to withdraw the stiffening member. The
pressure control can be manipulated to move fluid from the pre-load
volume 504 to the balloon volume.
[0596] Fluid entering the balloon 20 can cause the balloon 20 to
inflate and create a balloon void in the body.
[0597] The pressure control 494 can be withdrawn from the pressure
delivery body 498. Fluid pressure can then move from the inside of
balloon 20 back into pre-load volume 504. The device 2 and
inflation system 470 can then be withdrawn from the body.
[0598] The fluid that is transferred from pre-load volume 504 to
the balloon volume can be sealed in the device before use, for
example during manufacturing. The inflation system can have a fixed
pre-load volume 504 before use, such that a user does not need to
add fluid to the pre-load volume 504 during use. The inflation
system can be sealed or otherwise designed to prevent fluid, other
than fluid added to the pre-load volume 504 during manufacturing,
from entering the pre-load volume 504. The fluid in the pre-load
volume 504 can be water, air, saline, radiopaque dye, a gel, or
combinations thereof.
[0599] The volume of the pre-load volume 504 that can be delivered
to the balloon volume can be set to inflate the balloon 20 to a
pre-determined inflation size. The pre-load volume can be sealed
when the inflation system is manufactured or fluid can be added or
removed from the pre-load volume after manufacture of the inflation
system and before use.
[0600] For example, the pre-load volume 504 or maximum volume
deliverable to the balloon 20 (e.g., pre-load volume minus the
volume of the pre-load lumen 508 and the volume of the hollow
shaft) can be inflate the balloon 20 to a configuration where the
one or more balloon walls 22 are strained less than 5%, for example
less than 3%, also for example less than 1%.
[0601] The stiffening rod 474 can obstruct fluid from entering the
balloon 20 from the pre-load volume 504 when the stiffening rod 474
is in a closed configuration. The stiffening rod 474 can not
obstruct fluid from entering the balloon 20 from the pre-load
volume 504 when the stiffening rod 474 is in an opened
configuration. For example, the stiffening rod can be withdrawn
from the remainder of the inflation system in the second
configuration. The stiffening rod can be configured not to puncture
the balloon 20 in the closed or opened configuration.
[0602] FIG. 151D illustrates that the stiffening rod 474 can be in
the opened configuration. The pre-load volume can be in fluid
communication with the balloon. The stiffening rod can not obstruct
the pressure delivery body port.
[0603] FIGS. 152A through 152C illustrate that the stiffening rod
control 480 can control fluid delivery to the balloon 20. The
stiffening rod control 480 can manipulate the stiffening rod. The
stiffening rod control can retract proximally or extend distally
the stiffening rod. The stiffening rod can extend longitudinally
along the hollow shaft 2000. The pressure gauge 496 can communicate
the pressure in balloon 20 to the user. The balloon 20 can be
substantially compliant or substantially non-compliant. The hollow
shaft 2000 can have an inflation lumen extending between the
inflation system and the balloon 20.
[0604] FIG. 152C illustrates that the stiffening rod can have a
stiffening rod interface 499 that can mate to the inside of the
pressure delivery body, for example at screw threads (not shown).
The stiffening rod control can have a pressure tight seal with the
pre-load volume, such as at the o-ring seats. The stiffening rod
control can be connected to or integral with the stiffening rod.
Turning the stiffening rod control can extend and retract the
stiffening rod. A pressure disk 510 can have one or more o-ring
seats to form a pressure tight sliding seal with the pre-load
volume and the stiffening rod. The pressure disk 510 can freely
slide proximally and distally on the stiffening rod. A spring 514
can apply a force on the pressure disk 510 to push the pressure
disk 510 distally. O-ring seats (with o-rings, not shown) along a
stiffening rod step 512 can form a sealed and pressurized pre-load
volume when the stiffening rod control is retracted.
[0605] The pressure delivery body port 506 can be obstructed by the
stiffening rod step 512 when the stiffening rod is in a closed
configuration, for example, distally extended within the inflation
system. The pre-load volume and the pressure gauge can be in fluid
isolation, for example by one or more o-rings in o-ring seats, from
the balloon volume. The pre-load volume can be filled with air,
water, saline, radiopaque dye, a gel, or combinations thereof
[0606] FIG. 152D illustrates that when the stiffening rod control
480 is retracted (for example, rotating the control 480), the
stiffening rod can retract proximally within the inflation system
into an opened configuration. The stiffening rod step can move
proximally. The pressure delivery body port 506 can be in fluid
communication with the balloon 20 and the pressure gauge.
Proximally moving the stiffening rod control 480 can proximally
move the pressure disk within the pre-load volume. The pressure
disk can force fluid out of the pre-load volume, through the
pressure delivery body port and into the balloon 20. The pre-load
volume can decrease in volume. The balloon can inflate.
[0607] When the balloon 20 is positioned at a target site to be
treated, the stiffening rod control 480 can be rotated and/or
retracted to proximally move the stiffening rod with respect to the
pressure delivery body. The stiffening rod control and/or the
pressure control can regulate the inflation of the balloon 20, for
example, by the fluid in the pre-load volume. The inflation and
expansion of the balloon can create a void volume within in the
body. The stiffening rod control and/or the pressure control can
draw fluid from the balloon to the pre-load volume, deflating the
balloon. The balloon can then be withdrawn from the target
site.
[0608] The inflation system can be sealed to prevent fluid from the
pre-load volume, or otherwise, from being delivered balloon volume
until the stiffening rod has been proximally retracted (or distally
extended, depending on the design).
[0609] FIG. 153 illustrates that the stiffening rod 474 can have an
atraumatic or blunt stiffening rod tip 484 and be anchored at the
proximal end or base of the balloon 20. Inflation fluid can enter
and exit the balloon 20 through the lumen 154. The length of the
stiffening rod 474 is chosen such that when the balloon 20 is fully
inflated, the blunt stiffening tip 484 will extend into the balloon
volume, but not touch the inside of the balloon wall.
[0610] FIGS. 154A and 154B illustrate that a deployment sheath 516
can be placed circumferentially around a pleated balloon 20 in a
contracted configuration. The sheath 516 can contain the balloon
and prevent radial expansion of the balloon. The sheath can be
retracted with respect to the balloon when the balloon is deployed
through a cannula or into a target site. The sheath can have an
open distal end. The distal end can have leaflets 518. The balloon
can be pushed through the leaflets 518 during deployment.
[0611] FIGS. 155A and 155B illustrates that the sheath can be
placed around half of the balloon. The sheath can be placed around
180.degree. of the balloon, as measured from the longitudinal axis.
The balloon can exit from the distal end or lateral side of the
sheath.
[0612] FIG. 156 illustrates that the inflation system 470 can
connect to the hollow shaft or tube 2000. The hollow tube 2000 can
be soft and flexible. The hollow tube 2000 can be permanently
connected to the inflation system 470. The inflation system can
have a delivery syringe and/or pump. The hollow tube 2000 may have
a fitting (not shown) that may allow it be disconnected from the
inflation system.
[0613] The hollow tube 2000 can connect to a fitting. The fitting
can connect to the balloon 20. The balloon 20 is shown in a
compacted condition such that it can moved though a tube and
inserted in the body. The balloon volume can be in fluid
communication with the inflation system, for example the pump.
[0614] The interior volumes of the tube the pump the balloon and
the fitting may be filled with saline solution, radiopaque dye, a
gel, air, distilled water, or combinations thereof during
manufacture. The volume of fluid in the device 2 and the inflation
system can be such that when the inflation system 470 has delivered
a maximum output (i.e., all the fluid that can be delivered by the
inflation system 470 has been delivered) of fluid to the balloon,
the balloon can be substantially inflated to a maximum rated
inflation size for the balloon. The inflation system can be sealed,
for example to prevent addition or removal of fluid from the system
except when used with the balloon 20.
[0615] The inflation system can be configured to receive or
evacuate excess fluid other than to the balloon. For example the
inflation system can have a connector or valve for receiving or
evacuating fluid.
[0616] The inflation system 470 and/or device 2 can be sealed under
vacuum during manufacture. The balloon can be sealed under vacuum
during manufacture. A membrane or soft plug can separate the
inflation system from the hollow shaft and/or balloon before use.
Raising the pressure in the inflation system can cause the membrane
or plug to open and allow fluid into the balloon 20.
[0617] FIG. 157 illustrates that delivery rod or manipulation tool
520 can have a manipulation tool handle 528. The manipulation tool
520 can have a manipulation tool shaft 522. The manipulation tool
520 can have an interface fitting or clasp 526. The manipulation
tool shaft 522 can have a manipulation tool shaft diameter 524. The
manipulation tool shaft 522 can be solid or hollow. The
manipulation tool shaft can be rigid or semi-rigid.
[0618] FIG. 158 illustrates that the cannula 468 has been inserted
to a target site within a body 530. The cannula 468 can have an
inner lumen that can act as a delivery passage to the target site.
The balloon 20 can be inserted into cannula 468 by hand. The
balloon 20 can fit tightly or snugly inside of the cannula 468. A
force parallel to the longitudinal axis of the cannula can be
applied to advance the balloon 20 through the cannula. The hollow
tube 2000 can be too flexible to reasonably deliver enough force to
advance the balloon 2000 though the cannula.
[0619] FIG. 159 illustrates that the clasp 526 on the manipulation
tool 520 can interface with the fitting 594 so that the
manipulation tool 520 can apply forces for maneuvering the balloon
20 outside and inside of the cannula 428. The manipulation tool 520
can translate the balloon 20 longitudinally distal and/or proximal
within the cannula. The manipulation tool 522 can rotate the
balloon within the cannula.
[0620] FIGS. 160 and 161 illustrate that the manipulation tool 520
can advance the balloon 20 partially into the cannula.
[0621] FIG. 162 illustrates that the balloon 20 can be delivered to
a target site in the body. The manipulation tool 520, for example
at the clasp 526, can be removed from the fitting 594. The hollow
tube 2000 can be highly flexible. Wherein the hollow tube 2000
exits the cannula 468 the hollow tube can bend and lay
substantially flat (as shown) on the top surface of the cannula
468. The tube 2000 can not substantially obstruct the space
directly above cannula 468. The hollow tube 2000 can be rigid or
floppy and buckle easily. When cantilevered out 2 cm, the hollow
tube 2000 can deflect about 1 cm at less than about 0.015 N-m of
torque, more narrowly at less than about 0.005 N-m of torque.
[0622] FIG. 163A illustrates that the fitting 594 can have a distal
shaft interface. The distal shaft interface can have a hexagonal
transverse cross-section. FIG. 163B illustrates that the driving
rod or manipulation tool 520 can have a clasp 526 at the distal end
of the manipulation tool shaft 522. The interface fitting 594 can
be configured to transmit force and torque through and removably
attach to the clasp 526. The clasp can have a hexagonal transverse
cross-section or four sides of a hexagon. The clasp can have an
open lateral side for the distal shaft fitting 594 to be inserted
and removed.
[0623] FIG. 164A illustrates that the fitting 594 can have a square
or rectangular cross-section. FIG. 164B illustrates that the clasp
526 can have a square or rectangular transverse cross-section or
three sides of a square.
[0624] FIG. 165A illustrates that the fitting 594 can have a one or
more or pins or pegs extending laterally. The fitting 594 can have
a circular or oval cross-section. FIG. 165B illustrates that the
clasp 526 can have one, two or more peg receivers. The distal shaft
interface can have a circular, oval, partial circle, or partial
oval transverse cross-section.
[0625] FIGS. 166A and 166B illustrate that the fitting 594 can have
a circular shape with a projecting rectangular feature. The clasp
526 can have a female geometry that interfaces with rectangular
feature of the fitting 594. The clasp 526 can be
semi-cylindrical.
[0626] FIG. 167 illustrates that fitting 594 can be a circular
fitting with a stop or longitudinal interference fitting element.
The clasp 526 can have a cylindrical or hemi-cylindrical shape, for
example that can encompass more than angularly half of the fitting
594.
[0627] FIG. 168 illustrates that interface 594 can be a male shear
geometry. The clasp 526 can be a scissor-type device having two
pivoting grasping jaws.
[0628] FIG. 169 illustrates that interface 594 can have a male
shear geometry. The clasp 526 can have a tweezer configuration
having two resiliently bending jaws.
[0629] The clasp 526 may be able to pull, push or turn the fitting
594 through the cannula or at the target site.
[0630] FIG. 170 illustrates that the manipulation tool 520 can have
jaw arms 534a and 534b. The jaw arms can be parallel to each other
and form a continuous U-shaped distal configuration of the
manipulation tool. The interface 594 can have a male shear geometry
that can mate with the geometry of the jaw arms 534 and/or the
u-shaped configuration. The first jaw arms 534a can be rotationally
attached to the second jaw arms 534b at a second pivot 532b. The
manipulation tool first and second shafts 522a and 522b can be
solid or hollow rigid rods or flexible cables. The manipulation
tool first shaft 522a can be rotationally attached to the first jaw
arm 534a at a first pivot 532a. Pulling the manipulation tool first
shaft 522a with respect to the manipulation tool second shaft 522b
can cause the outward rotation, as shown by arrow, of the first jaw
arm 534a. This rotation can manipulate the position and orientation
of the balloon 20, and/or release the fitting 594 from the
manipulation tool 520.
[0631] FIG. 171A illustrates that the manipulation tool shaft 522
can have a tapered profile. FIG. 171B illustrates that the
manipulation tool shaft 522 can have a circular profile. FIG. 171C
illustrates that the manipulation tool shaft 522 can have an
elliptical profile. FIG. 171D illustrates that the manipulation
tool shaft 522 can have a rectangular profile. The corners of the
rectangle may be rounded (not shown). FIG. 171E illustrates that
the manipulation tool shaft 522 can have a hemispherical profile.
FIG. 171F illustrates that the manipulation tool shaft 522 can have
a hemispherical profile wherein the normally flat half of the
surface can be convex. FIG. 171G illustrates that the manipulation
tool shaft 522 can have a hemispherical profile wherein the
normally flat half of the surface can be concave. FIGS. 171H and
171i illustrate that the manipulation tool shaft 522 can be a
portion of tube, for example 120.degree. or 240.degree. of the
tube. The manipulation tool shaft 522 can be open on a lateral
side. The manipulation tool shaft 522 can have stops, notches or
threads to keep the manipulation tool from being inserted into the
cannula past a certain length or allow the insertion into the
cannula to happen at a controlled rate.
[0632] FIGS. 172A and 172B illustrate that the manipulation tool
520 can have a manipulation tool first shaft 522a radially inside a
manipulation tool second shaft 522b. The manipulation tool first
shaft can have preformed tangs 534a and 534b at the distal end of
the manipulation tool first shaft. The distal end of the
manipulation tool second shaft 522b can have a notch 538 that can
radially constrain the tangs 534. The tangs 534a and 534b can be
formed to spring radially outward when not constrained. When the
manipulation tool second shaft is slid down toward the fitting 594,
the manipulation tool can press the tangs radially inward around
the fitting, attaching the manipulation tool to the fitting. The
fitting can be detached from the manipulation tool by sliding the
manipulation tool second shaft away from the fitting. The
manipulation tool can have a lateral shaft port 536 through which
the hollow tube 2000 (not shown) can extend through and exit the
manipulation tool.
[0633] FIGS. 173A and 173B show that the manipulation tool 522 can
straight or curved. The curved manipulation tool shaft, shown in
FIG. 173B, can be made of a super elastic material, such as
Nitinol. The manipulation tool shaft can be straightened for
insertion through the cannula, and curve after exiting the cannula
468.
[0634] FIGS. 174A and 174B illustrate that the inflation system 470
can have a valve system 542, a filled syringe 472, a t-connector
540, a cap 548 and a delivery pump or delivery syringe 588. The
valve system 542 can be attached to a first port 560a of the
t-connector 540. The delivery syringe 588 can be connected to a
second port 560b of the t-connector 540. The cap 548 can be
attached to the third port 550c of the t-connector.
[0635] The check valve can have a check spring 550 and a valve ball
552. The swabbable valve can be attached to the filled syringe at a
syringe interface 554. The swabbable valve can be attached to the
check valve at an intervalve interface 556. The check valve can be
attached to the t-connector at a first connector interface 558a.
The delivery syringe can be attached to the t-connector at a second
connector interface 558b. The cap can be attached to the
t-connector at a third connector interface 558c. Any or all of the
interfaces in the inflation system can be fixed or detachable
connections, such as threaded connectors, luer connectors, glue,
snap connectors, welds, or combinations thereof.
[0636] The valve system 542 can have a swabbable valve 544
connected to a check valve 546. The check valve 546 can be
configured to allow flow into the t-connector 540 and prevent flow
out of the t-connector 540 through the valve system 542.
[0637] A pre-filled syringe 472 of fluid can be attached to the
valve system. The fluid can be a saline solution, a radiopaque
solution, water, a gel, an epoxy or curable polymer, or
combinations thereof. The fluid can be pushed through the swabbable
valve 544 and the check valve 546 and into the delivery syringe
588. The delivery syringe plunger can be pulled as the pre-filled
syringe plunger is pushed.
[0638] After the fluid is delivered to the delivery syringe 588,
the cap 548 can be removed and a fluid conduit, such as the hollow
shaft 2000, can be attached to the t-connector third port 558c in
place of the cap 548. The fluid conduit 2000 can be positioned to
have an output port at a target site, such as into the balloon 20
in a vertebral body. The delivery syringe plunger can be deployed,
forcing fluid through the fluid conduit and to the target site. The
balloon 20 can inflate, creating a void within cancellous bone at
the target site. The check valve and swabbable valve can minimize
or prevent flow to the pre-filled syringe during deployment of
fluid from the delivery syringe to the fluid conduit. A manual
valve does not need to be adjusted to direct the fluid to the fluid
conduit.
[0639] FIG. 175 illustrates that a kit can be packaged to contain a
balloon 20, driving rod or manipulation tool, fluid filled syringe
472, delivery or inflation syringe 588, or combinations thereof.
The pre-filled syringe can be filled with the inflation fluid 586.
The kit can be in a sterile package. The balloon can have a
flexible conduit, such as the hollow tube 2000, attached to the
first fluid port of the balloon 20.
[0640] FIG. 176 illustrates that the kit can have the balloon,
driving rod, and the inflation syringe. The inflation syringe can
be filled with a fluid such as saline solution, a radiopaque
solution, water or combinations thereof. The kit can be in a
sterile package.
[0641] FIG. 177 illustrates that the kit can have the balloon,
driving rod, and the inflation syringe. The balloon can be attached
to and in fluid communication with a flexible tube. The flexible
tube can be attached to and in fluid communication with the
inflation syringe. The inflation syringe can be pre-filled with the
inflation fluid 586. The kit can be in a sterile package 584.
[0642] FIG. 178 shows a cross section of the heart 562. The heart
562 has an aorta 568, a left ventricle 570 and an aortic valve
564
[0643] FIGS. 179A and 179B and 179C illustrate that a guidewire 572
can be inserted through the aorta 568 and positioned in the left
ventricle 570 of the heart 562. The device 2 can be slidably
inserted over the guidewire through the aorta 568. The device 2 may
be in a deflated state when first placed in the aortic valve 564.
The device 2 can be positioned to align along the balloon
longitudinal axis with the balloon with the aortic valve leaflets
566. The device 2 can also be rotated about the balloon
longitudinal axis to align with the aortic valve 564, for example
when cutting apart attached leaflets 566 in a bicuspid aortic valve
with a flange, vane, blade, other cutting element described herein,
or combinations thereof.
[0644] FIG. 179D shows the balloon 20 in an expanded configuration.
The device 20 can be non-compliant and open the aortic valve 564 to
a precise dimension (for example, about 20 mm or about 24 mm). The
balloon 20 can fixedly reconfigure and press the aortic valve
leaflets 566 against the outer wall or annulus 582 of the aortic
valve 564. The balloon 20 can radially expand the aortic valve
annulus 582.
[0645] The balloon can have an annular lumen 160, as shown in FIGS.
36A through 40. Natural blood flow through the aortic valve can
flow through the annular lumen 160 when the balloon is in an
inflated or expanded configuration in the aortic valve. The device
can have a device valve. The device valve can open and close, for
example depending on the ventricular pressure against the device
valve.
[0646] A radially expandable implant 156, such as a stent,
anchoring annulus or other component of a replacement heart valve,
including the replacement valve, or combinations thereof, can be
removably attached to the balloon before deployment. The balloon
can deploy the radially expandable implant 156 in the aortic valve,
for example at the annulus of the aortic valve. The balloon can
deliver and deploy a percutaneous aortic valve at the aortic valve
annulus.
[0647] FIG. 179E illustrates that the balloon can be deflated,
contracted and withdrawn from the aortic valve.
[0648] FIG. 179F shows the aortic valve in an opened configuration
at a larger dimension than before the procedure.
[0649] The method described supra can be performed on an aortic,
mitral, pulmonary, tricuspid or vascular valve.
[0650] FIG. 180A illustrates that the balloon can be positioned in
a narrowed, atherosclerotic length of a blood vessel 574 having
atherosclerotic plaque 576 on the interior of the vessel wall 578.
The vessel 574 can have a vessel lumen 580 through which blood can
flow.
[0651] FIG. 180B illustrates that the balloon 20 can be inflated
and expanded. The balloon 20 can remodel the vessel, pushing the
sclerotic plaque radially away from the balloon longitudinal axis.
The balloon 20 can deploy a vascular stent to the sclerotic length
of the vessel.
[0652] FIG. 180C illustrates that the balloon 20 can be deflated,
contracted and removed from the narrowed length of the vessel 574.
The vessel lumen 574 can remain patent after the balloon is
removed, for example restoring blood flow past the treated
atherosclerotic length.
[0653] The balloon 20 can be implanted in the body semi-permanently
or permanently. The balloon 20 can have one, two or more openings
for fluid entry and/or exit.
[0654] Any elements described herein as singular can be pluralized
(i.e., anything described as "one" can be more than one), and
plural elements can be used individually. Any species element of a
genus element can have the characteristics or elements of any other
species element of that genus. The term "comprising" is not meant
to be limiting. The above-described configurations, elements or
complete assemblies and methods and their elements for carrying out
the invention, and variations of aspects of the invention can be
combined and modified with each other in any combination.
* * * * *