|Publication number||WO2000023009 A1|
|Publication date||27 Apr 2000|
|Filing date||21 Oct 1999|
|Priority date||21 Oct 1998|
|Also published as||CA2347977A1, EP1123068A1|
|Publication number||PCT/1999/24467, PCT/US/1999/024467, PCT/US/1999/24467, PCT/US/99/024467, PCT/US/99/24467, PCT/US1999/024467, PCT/US1999/24467, PCT/US1999024467, PCT/US199924467, PCT/US99/024467, PCT/US99/24467, PCT/US99024467, PCT/US9924467, WO 0023009 A1, WO 0023009A1, WO 2000/023009 A1, WO 2000023009 A1, WO 2000023009A1, WO-A1-0023009, WO-A1-2000023009, WO0023009 A1, WO0023009A1, WO2000/023009A1, WO2000023009 A1, WO2000023009A1|
|Inventors||John T. Frauens|
|Applicant||Frauens John T|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (8), Referenced by (69), Classifications (33), Legal Events (13)|
|External Links: Patentscope, Espacenet|
APPARATUS FOR PERCUTANEOUS INTERPOSITION BALLOON ARTHROPLASTY
FIELD OF THE INVENTION This invention relates to a method and apparatus for performing arthroplastic surgery for the interposition of balloons within joints. Specifically, this invention relates to a method and apparatus for performing percutaneous interposition balloon arthroplasty for the repair of
movable and mixed articulating joints in the body.
BACKGROUND OF THE INVENTION
There are three basic classifications of joints of the human body: synarthroidal, amphiarthroidal, and diarthroidal. Synarthroidal joints provide immovable articulations;
amphiarthroidal joints provide mixed articulations; and diarthroidal joints provide movable articulations. Healthy fibrocartilage and hyaline cartilage within the joint provide a weight bearing function and allow painless articulation of amphiarthroidal and diarthroidal joints.
Primary osteoarthritis is a debilitating disease that affects amphiarthroidal and diarthroidal joints. The changes that occur with primary osteoarthritis involve altered biomechanical, biochemical, histologic and metabolic characteristics of the cartilage, synovial fluid and bone. Initially, these changes affect the articular cartilage and eventually affect the
surrounding perichondral tissues in a cascade of events. Articular cartilage comprises 70-
80% water and functions as a weight bearing surface by its unique interaction between the water and cartilage matrix. There are many theories concerning how articular cartilage
functions as a weight bearing surface which include hydrodynamic, boundary, elastohydrodynamic and squeeze film lubrication. However, it is known that the viscoelastic properties contribute to the multiple functions of articular cartilage, including its weight bearing function. The viscoelastic properties of cartilage are due to an intricate tight meshwork of interlacing collagen fibers that physically ensnare the large macromolecules of proteoglycan. For example, in a typical case of osteoarthritis of the hip joint, the femoral head
remains covered with fibrocartilage over a third to two-thirds of its surface, but in the superior weight bearing region, the lining tissue becomes considerably thinner, although intact throughout. Where thin, the lining tissue is partly fibrocartilage, and partly fibrous,
displaying focal areas of cystic degeneration. However, where fibrocartilage is present, the
thickness of the membrane between the femoral cup, cacetabulum, and the bone does not generally exceed 2 mm.
To treat osteoarthritis effectively, procedures are needed for repairing amphiarhroidal and diarthroidal joints that prevent the disintegration of fibrocartilage and that restore the
viscoelastic properties of articular cartilage for an indefinite period of time. Historically, repair of the joint was conducted by disintegration of the diseased tissue
followed by fibrous repair. However, this method has significant disadvantages, even when accompanied by conventional arthroplasty.
Orthopedic surgeons who specialize in total joint arthroplasties have been uncomfortable with performing resections of an entire joint. In the hip joint, for example, the
entire acetabulum down to the intra-pelvic bone and the proximal femur would have to be resected. Sections of the proximal femur that are resected in this procedure include the
femoral head, neck and intramedullary bone of the upper half of the femur. However, the pathology in primary osteoarthritis is initially and primarily isolated to the articular cartilage.
Thus, the resected tissue is many times greater than the surface area actually responsible for
the patient's symptoms.
Traditionally, osteoarthritis of the hip has been treated in one of two ways: arthroplasty utilizing foreign substances of non-animal origin, and other methods that ameliorate pain and disability in osteoarthritis of the hip. Arthroplastic procedures that
consist of interposing membranes, metallic cups, or other inserts to sustain the joint space
until new joint spaces can regenerate have been extensively used in the prior art.
Cup or mould arthroplasty has commonly been used to treat degenerative arthritis of the hip joint. This procedure consists of denuding the femoral head and the acetabulum to bleeding bone, and reshaping them into a ball and socket joint with a metallic cup interposed
between the two surfaces. The aim of mould arthroplasty is the formation of smooth glistening fibrocartilage around the periphery of the articular surface and hyaline cartilage in the central portion. Smith-Petersen concluded that, in response to physiologic stresses of friction and intermittent pressure of movement and supported weight-bearing, the repairing tissue will mold into smooth fibro-cartilage and in some instances to hyaline cartilage. M.N.
Smith-Petersen, 21 J. Bone & Joint Surg. 269 (1939). Other inventors used mould arthroplasty with varying degrees of success. P'ean and Chlumsky were the first to utilize foreign materials in arthroplasty, the former in human joints, while the latter experimented with an array of metal plates and films of celluloid, rubber, and collodion; Sir Robert Jones
successfully utilized a strip of gold foil to cover the reconstructed head of the femur; Pupovac
used magnesium plates; and Rehn was the first to use cup arthroplasty when he inserted a previously molded cap-like appliance of steel into the acetabular side of the hip joint. Paul H. Harmon, 76 Surg. Gyn. Obst. 347 (1943). Smith-Perterson utilized cups of various materials: glass, viscaloid, pyrex glass, bakelite, and vitallium. M.N. Smith-Peterson, J. M. J. Bone Surg., 18: 869 (1936). Vitallium was the most successful material used in cup arthroplasty.
However, cup arthroplasty caused severe trauma in patients and showed poor formation of hyaline cartilage. Other approaches have been used to repair disease of joints in the human body. For
instance, in the vertebral column, a collapsible plastic bladder-like prosthesis with the same
shape as the nucleus pulposis of an intervertebral disc is delivered via a stem into the space
between the vertebrae. U.S. Pat. No. 3,875,595 (Froning). A method and apparatus has been described for the repair of tissue in the vertebral column, such as fibrocartilage, using a bladder-like prosthesis device that can be inserted into the disc space and thereby infused with biomaterial to distract the space and provide a permanent replacement disc. However, this method addresses only prosthetic placement in the vertebral column. PCT Pat. App. No.
WO 97/26847 (Felt, et al). In yet another case, an arthroscopically implantable prosthetic device consisting of a pair of multi-compartment rings shaped to fit into a joint and filled with a polymeric substance is used to restore function to a diseased joint. U.S. Pat. No.
What is needed is a method and apparatus for restoring the function of movable and
mixed articulating joints and for repairing fibrocartilaginous tissue and restoring the
viscoelastic properties of articular cartilage in amphiarthroidal joints such as the hip for an indefinite period of time. SUMMARY OF THE INVENTION
The current invention provides a method and related materials for percutaneous interposition arthroplasty, comprising the steps of entering the joint with a probing device, introducing a deflated balloon within the joint, and inflating the balloon. Moreover, this method may further comprise the step of distending and debriding the joint prior to
introducing the deflated balloon, the step of keeping ligaments (e.g., the ligamentum teres)
intact, the step of resecting the ligaments, the step of closing the puncture wound, and the step of removing the balloon. Combinations of these steps are considered part of this invention.
In addition, this invention is a balloon suitable for percutaneous interposition arthroplasty and comprising an outer shell and a filler solution. The filler solution may be a condensed phase composition, a gas composition, or mixtures of gases and condensed phases.
Condensed phase compositions include, but are not limited to, polymers, curable condensed compositions, gels, resins, liquids, and solutions. This group further includes, for example, silicone-gel, saline solution, and soybean oil. Gas phase compositions may include, but are
not limited to, air, nitrogen, oxygen, argon, carbon dioxide, and mixtures thereof. The balloon may be any shape, may have multiple compartments, may be capable of withstanding
significant pressures, and may be relatively impenetrable. Combinations of filler solution materials are considered part of this invention.
The interposition of a balloon may also facilitate the repair or reformation of the cartilage tissue on the surfaces of the bones of the joint. BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 shows primary osteoarthritis of the hip joint. Figure 2 shows hip joint distention and arthroscopic placement. Figure 3 shows balloon introduction.
Figure 4 shows balloon inflation. Figure 5 shows interposition balloon arthroplasty.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a method and related devices for repairing joints and surrounding tissues by minimally invasive means. In particular, the invention provides a method and related materials for using minimally invasive means to repair and reconstruct tissue such as fibrocartilage, particularly fibrocartilage associated with diarthroidal and amphiarthroidal joints. The method involves using minimally invasive means to prepare the site of pathology, and distending a joint site in situ in order repair the damaged joint.
The method comprises the steps of: a. performing surgery to enter the joint; b. using a minimally invasive means to remove damaged or diseased
material from a narrowing joint space and nearby tissues; c. introducing at least one deflated balloon to a cavity; and d. inflating the balloon. Arthroscopy has revolutionized knee surgery but has been of minimal use, for example, when it comes to hip pathology. However, arthroscopy is applicable to the hip joint. The hip joint is well suited for balloon arthroplasty because the hip is accessible percutaneously without disturbing its blood supply. Furthermore, the joint can be significantly distended by releasing its inherent negative pressure, resulting in a relatively uncomplicated surgical process as the space between the acetabular fossa and the head of the
femur can serve as a suitable cavity for the delivery and inflation of a balloon. The surfaces of the acetabular fossa, the femoral head and surrounding tissues can be treated or covered
with a suitable material in order to enhance their integrity and use as a cavity. Moreover, the
ligamentum teres may be preserved or resected to ensure a permanent replacement procedure.
The ligamentum teres is vital only in infancy and childhood. By adulthood, the primary blood supply to the femoral head is through the anterior and posterior femoral circumflex arteries. As a result, the ligamentum teres can be resected with balloon insertion
while maintaining the blood supply through the circumflex arteries. The advantage of preserving the ligamentium teres is to add to the stability of the femur.
The procedure consists of, first, making an appropriate incision. Then, through a probing device such as an orthoscope, the hip joint is entered, distended and debrided. Depending on the circumstances, the ligamentum teres may be preserved. The debriding step
is optional. Then, through a probing device, a deflated balloon may be introduced within the
joint and distended similar to the fashion in which a breast implant is filled with saline. The arthroscopic introducer-inflator may be removed and the puncture wound(s) closed. Rehabilitation for such a procedure is relatively minimal. The advantages include joint space restoration with restoration of viscoelastic dynamics. Additionally, a total hip replacement
would remain viable if the procedure should fail. Moreover, a surgeon could wait for a
predetermined period of time and then remove the balloon implant if desired. This procedure permits the femoral head to be resurfaced (with the balloon or,
subsequently, by repair or reformation of the cartilage) without dislocating the hip which in
some circumstances would disrupt the blood supply, thereby causing avascular necrosis. The procedure, therefore, allows full access to the femoral head for complete resurfacing while maintaining the primary blood supply. Surgeons could reduce total hip arthroplasty with its inherent risks and complications to a brief, percutaneous, out-patient procedure with minimal risk plus maintenance of anatomy should a formal hip resection and replacement be required later on. Similar procedures could be used for balloon arthroplasty in other joints.
PREPARING THE JOINT SPACE AND INSERTING A BALLOON
The description of the preparation of the joint space and insertion of a balloon are
described for the hip joint. Similar procedures can be used for balloon arthroplasty of other joints. Figure 1 shows primary osteoarthritis of the hip joint. This may be characterized, in
part, by a narrowing joint space 10, cartilage loss 20, and thickening joint capsule 30. The
narrowing joint space 10 is the space between the head of the femur 40 and the acetabular
fossa 50. Other symptoms may exist and are well known to those in the art.
The procedure for balloon arthroplasty contains the following steps as appropriate.
(i) Assessment of the extent of osteoarthritis.
(ii) Distension of the joint. (iii) Orthoscopy into the joint space.
(iv) Optional removal and/or cleaning of destroyed tissue.
(v) Delivery of a deflated balloon. (vi) Inflation of the balloon.
(vii) Optional deflation/removal of the balloon.
Performing the surgery for entering the hip joint can be carried out using techniques
well within the skill of those in the art. The narrowing joint space 10 may be viewed, for
instance, by remote visualization techniques such as fiberoptic visualization. The integrity of the hip and femur can be assessed, and optionally, repaired, for example, by the application of a biocompatible patching material, such as a fibrin glue.
Figure 2 shows hip joint distention and arthroscopic placement. In some patients, joint distention is unnecessary. However, if a surgeon desires, distention may be achieved by mechanical displacement of the femur with respect to the acetabular fossa. The joint space
10 can be distended prior to and/or during either the preparation and/or delivery of the
balloon. Distension can be accomplished by any suitable means, including by mechanical
and/or hydrostatic means. A surgeon can employ external traction. An orthoscope 100 may
be inserted into the cavity 110 formed by distending the narrowed joint space 10. The
deflated balloon may then be placed into the distended cavity. If required, the destroyed pelvic and femur related tissue such as fibrocartilage may be removed and cleaned prior to inserting the deflated balloon. The remaining, repaired tissue
and bone matter serve as a support for an inflated balloon. The head of the femur 40 engages
a balloon 300 like a penile condom. The ligamentum teres may be preserved, so as to allow
any balloon to occupy the cavity, 110, except for the void around the ligamentum teres. See,
for example, Figure 5. Once the damaged material has been removed and the remaining joint tissues repaired, the joint space 10 may be used as a cavity 110 to contain a delivered balloon.
The joint space 10, including any repaired portions is created to be of sufficient dimension to allow a deflated balloon to be delivered and distended. By the use of distension, the joint
space 10 can be sufficiently re-established to achieve any desired final dimension and
position. The means used to accomplish distension (for example, another balloon or other
mechanical devices) may also form at least one barrier (for example, a cavity 110) for the
balloon. The narrowed joint space 10 may be easily distended by the use of one or more
inflatable balloons. When inflated, a balloon provides rigid walls that are capable of
expanding the joint space 10. An inflatable balloon provides sufficient strength and
dimensions and can be prepared using conventional materials. In use, the deflated balloon
can be delivered to the narrowed joint space 10 and inflated to separate the space 10. For
example, a balloon may be inserted with an orthoscope. Under certain circumstances, distension prior to the insertion of the inflatable balloon is unnecessary.
Once positioned within the cavity 110, Figure 4 shows that the orthroscope 100 may
be used to inflate a balloon by injecting a suitable filler solution (not shown) to create an
inflated balloon 300. Depending on the application, the same or different orthoscope may be
used for insertion of the deflated balloon 200, and for inflating the deflated balloon 200. For
example, an orthroscope 100 may be inserted into the space 10 to deliver an deflated balloon and a second probing device used to inflate the deflated balloon.
A suitable gas (for example, nitrogen, carbon dioxide, oxygen, argon, etc.) may be delivered in order to inflate the balloon in situ. Positioning of the balloon may be facilitated
by the use of ancillary means, such as using a C-arm cine , or by self-effecting means embodied within the balloon or the delivery apparatus. Suitable materials for preparing balloons of the present invention, for example, are those that may be used for balloon angioplasty. Suitable materials provide an optimal combination of such properties as compliance, biostability and biocompatability, and mechanical characteristics such as elasticity and strength. Balloons can be in any suitable form, including those having at least one layer and having at least one compartment when expanded. A useful balloon device will include the balloon (optionally having a plurality of lumens), a delivery probing device, and fluid or gas pressure means. An orthoscope may be used as a probing device.
Examples of suitable balloon outer shell 210 materials include, but are not limited to,
polyolefin copolymers, polyethylene, polycarbonate, and polyethylene terephthalate. Such polymeric materials can be used in either unsupported form, or in supported form, for
example, by the integration of polyethylene terephthalates or other fibers.
Balloons can also take several forms, depending on how the balloon is to be delivered and inflated. A single, thin walled balloon can be used, for instance, to contact and form a
barrier along the joint surface. A balloon can be provided that occupies less than the entire volume of the cavity 110. The balloon may be, for instance, in the shape of a cylinder or a
collapsed, bell tent.
Any portion, region or surface of the outer shell of the balloon 210 may be treated
with friction modifying coatings or other materials to improve or otherwise alter the physical
or chemical properties. A balloon of the present invention can be inflatably attached (for example, provided
in an releasable and deflated or inflated configuration) within or upon the end of a probing
device, in order to be inserted into the space 10 or cavity 110. Moreover, the balloon may be inserted using minimally invasive means, and remote visualization methods including
Once within the space 10 or cavity 110, the balloon can be finally positioned and delivered. The balloon may be self-venting, in that whatever volume of gas may be present within the balloon and shaft at the time of insertion can be displaced by the filler solution and vented through the balloon walls, for example, to the surrounding tissue. The balloon may be evacuated by the application of suction or vacuum to the shaft. Some or all of the gas present within the shaft and/or balloon may be vented through the balloon material by the deliver of a
filler solution. As the filler solution fills the balloon and displaces the gas the filler solution also serves to inflate the balloon to a desired extent, and in a suitable position within the
cavity 110 sufficiently distended, the filler solution may be cured, or permitted to fully cure,
in situ in order to retain the balloon and filler solution permanently in place. This step is
optional and depends upon the filler solution.
The balloon may be fabricated from natural or synthetic materials, including but not limited to, polymeric materials, such as films or membranes, and woven or nonwoven fabrics or meshes. Balloons that will not permit the effusion or diffusion of liquids, gels, solids, other condensed compositions and gases can be fabricated as one or more layers comprising such materials, and/or with one or more regions or portions of differing properties.
The materials used to fabricate balloons may provide an optimal combination of such
properties as biocompatability, biodurability, strength, wall thickness, wettability with a filler solution, puncture resistance, compliance, flexibility, modulus of elasticity, stress/strain curve
yield point, burst pressure, maximum inflation, Young's modulus, shear modulus, and the ability to be easily fabricated and sterilized. Examples of suitable balloon materials include, but are not limited to, solid polymeric materials such as membranes. Polymeric materials may be provided with suitable venting
holes. Suitable polymeric materials include, but are not limited to, elastomeric and other materials commonly used for angioplasty and related application, and include polyurethanes,
polyolefins, polyamides, polyvinyl chlorides, and polyethylene terephthalates, as well as various copolymers, combinations and permutations thereof.
Balloon materials are available commercially for use in filtration and other
applications, and include cloth and mesh formed of polymeric materials such as polyester,
polypropylene and nylon threads. A material may be reinforced, for example, with woven glass or fine fibers of other materials, to provide added strength or other desirable properties. Such materials can be selected to provide an optimal combination of such properties as strength, mesh opening, thread diameter, mesh count, percent open area, and cost. Examples
of suitable materials are commercially available and include, but are not limited to, nylon screen cloth, such a nylon mesh.
The balloons themselves may be fabricated by a variety of means. The balloon may be formed as a continuous (for example, unitary) and non-interrupted (for example, seamless) form. The balloon may be fabricated from a plurality of generally sheet-like portions, which
can be assembled and sealed together. Sealing may be accomplished by any suitable means, including by the use of adhesives, sewing, RF bonding, heat sealing, impulse sealing, and any
combination thereof. Once sealed, the balloon may be turned inside out in order to provide the sealed seam on the interior of the resultant balloon.
The balloon may be fabricated to assume any desired shape upon inflation, for
example, a generally oval shape, or the shape of a kidney bean, in order to approximate the natural anatomical shape of the space 10. The balloon may provide major surfaces for
contacting the principal surfaces of the joint, for example, the head of the femur 40 and
acetabular fossa 50. The balloon may further provide wall portions for contact with other
A balloon may be provided with one or more orientation markers, in order to permit the surgeon to determine the optimal orientation of the balloon in situ. Suitable orientation
markers include, but are not limited to, the placement of detectable markers or indications within or upon the balloon material and/or probing device, the marking or indications themselves being detectable by minimally invasive means, for example, by fiberoptic
visualization, interoperative magnetic resonance imaging (MRI), ultrasound, and laser radiation.
The deflated balloon may be positioned within the space 10 or cavity 110 following preparation. As described hereinabove, mechanical distension of the space can be used as well, for example, either while inserting and/or positioning a balloon and/or during inflation
of a balloon with filler solution.
Once in place within the cavity 110, the balloon may be filled by having the probing
device connected to a filler solution delivery device capable of delivering filler solution through the probing device and into the balloon under sufficient pressure. When in the form
of a curable polymer, the filler solution may begin to cure as it leaves the mixing chamber of
the delivery device. Saline, as a filler solution, will never cure. If a curing filler is chosen,
the cure rate of the biopolymer may be controlled, in combination with the dimensions and other conditions of the distension means, in order to provide sufficient time for the filler solution to expand the balloon before final curing occurs. Noncuring materials may change viscosity upon entering the cavity 110. Such changes may result from different pressures,
temperatures or both. In some cases, the phase of filler solution may change, for example, from gas to liquid or solid to liquid or gel, etc. The progress of inflating may be monitored,
for example, by C-arm cine or interoperative MRI.
"Cure" and inflections thereof, will refer to any change in the physical properties of a
material by chemical reaction or vulcanization. Curing may occur with the aid of any combination of heat, chemicals, catalysts, and energy, such as. but not limited to, light and
ultrasound. When used with regard to the method of the invention, for instance, "curable" can refer to uncured biomaterial, having the potential to be cured in vivo (as by the application of a suitable energy source), as well as to a biomaterial that is in the process of curing, as with a biomaterial formed at the time of delivery by the concurrent mixing of a plurality of biomaterial components.
Figure 5 shows interposition balloon arthroplasty upon completion. The balloon 300
becomes semi-circular shaped balloon 400, which encompasses the head of the femur 40.
The balloon can be left in place for a fixed period of time, and then removed by a similar procedure, or the balloon may be permanent. The balloon was constructed so that it would
form a semicircular shape and as it was distended would obtain stability by "locking" over the
expanse of the head-neck angle. The balloon may leave the ligamentum teres undisturbed.
FILLER SOLUTIONS Natural cartilage is a non-vascular structure found in various parts of the body.
Articular cartilage tends to exist as a finely granular matrix forming a thin incrustation on the surfaces of joints. The natural elasticity of articular cartilage enables it to break the force of concussions, while its smoothness affords ease and freedom of movement. Filler solutions
are intended to mimic many of the physical-chemical characteristics of natural tissue. Filler solutions can be provided as one component systems, or as two or more
component systems that can be mixed prior to or during delivery, or at the site of repair. Generally, fillers are flowable, meaning they are of sufficient viscosity to allow their delivery
into the balloon. The fillers may be heated or subject to pressure changes to aid flowing.
Moreover, the fillers may be solvated in a liquid, gel, or other condensed phase composition to aid flowing into the balloon with or without temperature or pressure changes. Suitable fillers may comprise gas phase compositions which include, but are not limited to, air, nitrogen, oxygen, argon, carbon dioxide, other inert gases, and mixtures thereof.
Filler solutions may be homogeneous (i.e., providing the same chemical-physical parameters throughout), or they can be heterogeneous. Filler solutions may be used that provide implants having varying regions of varying or different physical-chemical properties.
Common polymeric materials for use in medical devices include, but are not limited to, polyvinyl chlorides, polyethylenes, styrenic resins, polypropylene, thermoplastic
polyesters, thermoplastic elastomers, polycarbonates, acrylonitrilebutadiene-styrene ("ABS")
resins, acrylics, polyurethanes, nylons, styrene acrylonitriles, and cellulosic.
Suitable filler solutions are those polymeric materials that provide a suitable combination of properties relating to their device application and in vivo use. Such properties include, but are not limited to, processability and the ability to be stably sterilized and stored.
In the course of applying such material, such properties include in vivo flowability and moldability. The filler solution may comprise a thermosetting polyurethane polymer based on a
suitable combination of isocyanates, long chain polyols, and short chain (low molecular
weight) extenders and/or crosslinkers. Suitable components are available commercially and
are each may be used in the highest possible grade, for example, reagent or analytical grade or higher. Examples of suitable isocyanates include, but are not limited to, 4,4'-diphenyl methane diisocyanate ("MDI"), and 4,2'-diphenylmethane diisocyanate, including mixtures thereof, as well as toluene diisocyanate ("TDI"). Examples of suitable long chain polyols
include, but are not limited to, tetrahydrofuran polymers such as poly(tetramethylene oxide) ("PTMO"). Examples of suitable extenders/crosslinkers include, but are not limited to, 1,4- butanediol and trimethylol propane, and blends thereof. Such performance may be evaluated using procedures commonly accepted for the evaluation of natural tissue and joints. Curing is unnecessary, for example, for oils (carbon or
silicon based), water, saline solution, gels, resins and other condensed phases which may possess an optimal combination of physical chemical properties. Suitable gels, for example,
include silicone gels. Suitable oils include, for example, soybean oils. Filler solutions of the present invention may further include adjuvants and additives,
such as stabilizers, fillers, antioxidants, catalysts, plasticizers, pigments, and lubricants, to the
extent such ingredients do not diminish the utility of the composition for its intended purpose.
Filler solutions may be stable under conditions used for sterilization and stable on storage and in the course of delivery. They may be capable of flowing through a delivery
device to an in vivo location, and/or being cured in situ, as by exposure to an energy source such as light or by chemical reaction. Thereafter, a cured filler solution may be amenable to shaping and contouring. Uncured filler solutions may be shaped and contoured to the extent that the balloon and filler solution will allow.
One or more catalysts may be incorporated into one or more components of the
curable filler solutions in order to cure the filler solution in the physiological environment within a desired length of time. Curable filler solutions may be able to cure within about 5 minutes or less.
Means may be employed to improve the biostability, for example, the oxidative and/or hydrolytic stability, of the filler solution, thereby extending the life of the implant. Suitable
means for improving biostability include the use of aliphatic macrodiol such as hydrogenated polybutadiene (HPDI). By judicious choice of the corresponding diisocyanate (for example, MDI) and chain extender (for example, ethylenediamine), those skilled in the art will be able to achieve the desired packing density or crystallinity of the hard segments, thereby improving the hydrolytic stability of the cured polyurethane.
Filler solutions may be provided as a plurality of components, for example, a two-part
polyurethane system, may be mixed at the time of use using suitable mixing techniques, such as those commonly used for the delivery of two-part adhesive formulations. A suitable mixing device involves, for instance, a static mixer having a hollow tube having a segmented, helical vein running through its lumen. A two-part polyurethane system can be mixed by forcing the respective components through the lumen under pressure.
The foregoing description is intended to be illustrative of the invention, but is not to be considered as comprehensive or limiting of its scope.
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|International Classification||A61F2/32, A61F2/46, A61F2/30, A61F2/00, A61M25/00, A61B1/00, A61B17/56|
|Cooperative Classification||A61F2002/30617, A61F2002/30581, A61F2002/4635, A61F2230/0013, A61B1/00165, A61F2/4603, A61F2/30767, A61F2002/30125, A61F2002/30583, A61F2002/30133, A61F2002/30131, A61F2250/0097, A61F2002/30069, A61F2/30965, A61F2002/4685, A61F2230/0008, A61F2/30721, A61F2002/30757, A61F2210/0085, A61F2220/005, A61F2002/30448, A61F2230/0015, A61F2/32, A61F2/4618|
|European Classification||A61F2/30B, A61F2/46B|
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