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WO2000023009A1 - Appareil pour arthroplastie percutanee avec interposition de ballonnet - Google Patents

Appareil pour arthroplastie percutanee avec interposition de ballonnet Download PDF

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Publication number
WO2000023009A1
WO2000023009A1 PCT/US1999/024467 US9924467W WO0023009A1 WO 2000023009 A1 WO2000023009 A1 WO 2000023009A1 US 9924467 W US9924467 W US 9924467W WO 0023009 A1 WO0023009 A1 WO 0023009A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
joint space
joint
hip
minimally invasive
Prior art date
Application number
PCT/US1999/024467
Other languages
English (en)
Inventor
John T. Frauens
Original Assignee
Frauens John T
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Frauens John T filed Critical Frauens John T
Priority to JP2000576787A priority Critical patent/JP2002538850A/ja
Priority to CA002347977A priority patent/CA2347977A1/fr
Priority to EP99956606A priority patent/EP1123068A1/fr
Priority to AU13177/00A priority patent/AU1317700A/en
Publication of WO2000023009A1 publication Critical patent/WO2000023009A1/fr

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Classifications

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia

Definitions

  • 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
  • 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
  • Articular cartilage comprises 70-
  • 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
  • the lining tissue 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,
  • thickness of the membrane between the femoral cup, cacetabulum, and the bone does not generally exceed 2 mm.
  • Sections of the proximal femur that are resected in this procedure include the
  • the resected tissue is many times greater than the surface area actually responsible for
  • 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.
  • arthroplasty utilizing foreign substances of non-animal origin
  • other methods that ameliorate pain and disability in osteoarthritis of the hip.
  • 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
  • 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.
  • 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
  • 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.
  • 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
  • ligaments e.g., the ligamentum teres
  • 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
  • the balloon may be any shape, may have multiple compartments, may be capable of withstanding
  • 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.
  • 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.
  • the present invention provides a method and related devices for repairing joints and surrounding tissues by minimally invasive means.
  • 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
  • Arthroscopy has revolutionized knee surgery but has been of minimal use, for example, when it comes to hip pathology.
  • 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.
  • 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
  • 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
  • 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.
  • a deflated balloon may be introduced within the
  • 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
  • Figure 1 shows primary osteoarthritis of the hip joint. This may be characterized, in
  • narrowing joint space 10 is the space between the head of the femur 40 and the acetabular
  • the procedure for balloon arthroplasty contains the following steps as appropriate.
  • Performing the surgery for entering the hip joint can be carried out using techniques
  • the narrowing joint space 10 may be viewed, for
  • 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.
  • joint distention is unnecessary.
  • distention may be achieved by mechanical displacement of the femur with respect to the acetabular fossa.
  • Distension can be accomplished by any suitable means, including by mechanical
  • An orthoscope 100 may
  • 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
  • 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,
  • 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.
  • distension the joint
  • space 10 can be sufficiently re-established to achieve any desired final dimension
  • the means used to accomplish distension for example, another balloon or other
  • At least one barrier for example, a cavity 110
  • the narrowed joint space 10 may be easily distended by the use of one or more
  • a balloon When inflated, a balloon provides rigid walls that are capable of
  • An inflatable balloon provides sufficient strength and
  • a balloon may be inserted with an orthoscope. Under certain circumstances, distension prior to the insertion of the inflatable balloon is unnecessary.
  • Figure 4 shows that the orthroscope 100 may
  • 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.
  • a suitable gas for example, nitrogen, carbon dioxide, oxygen, argon, etc.
  • Suitable materials for preparing balloons of the present invention 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.
  • Suitable balloon outer shell 210 materials include, but are not limited to,
  • polyolefin copolymers polyethylene, polycarbonate, and polyethylene terephthalate.
  • polyethylene polyethylene
  • polycarbonate polycarbonate
  • polyethylene terephthalate polyethylene terephthalate
  • 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
  • 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
  • Any portion, region or surface of the outer shell of the balloon 210 may be treated
  • a balloon of the present invention can be inflatably attached (for example, provided
  • the balloon may be inserted using minimally invasive means, and remote visualization methods including
  • 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
  • the 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
  • the filler solution may be cured, or permitted to fully cure,
  • 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 materials
  • suitable balloon materials include, but are not limited to, solid polymeric materials such as membranes. Polymeric materials may be provided with suitable venting
  • Suitable polymeric materials include, but are not limited to, elastomeric and other materials commonly used for angioplasty and related application, and include polyurethanes,
  • polystyrene resins polystyrene resins
  • polyamides polyamides
  • polyvinyl chlorides polyvinyl chlorides
  • polyethylene terephthalates as well as various copolymers, combinations and permutations thereof.
  • Balloon materials are available commercially for use in filtration and other
  • 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
  • suitable materials 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
  • Sealing may be accomplished by any suitable means, including by the use of adhesives, sewing, RF bonding, heat sealing, impulse sealing, and any
  • 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
  • the balloon may provide major surfaces for
  • 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
  • MRI magnetic resonance imaging
  • ultrasound ultrasound
  • laser radiation
  • the deflated balloon may be positioned within the space 10 or cavity 110 following preparation.
  • mechanical distension of the space can be used as well, for example, either while inserting and/or positioning a balloon and/or during inflation
  • the balloon may be filled by having the probing
  • the filler solution may begin to cure as it leaves the mixing chamber of
  • 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,
  • 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,
  • C-arm cine or interoperative MRI for example, by C-arm cine or interoperative MRI.
  • Curing may occur with the aid of any combination of heat, chemicals, catalysts, and energy, such as. but not limited to, light and
  • 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
  • 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
  • the balloon may leave the ligamentum teres undisturbed.
  • 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 can be provided as one component systems, or as two or more
  • fillers are flowable, meaning they are of sufficient viscosity to allow their delivery
  • the fillers may be heated or subject to pressure changes to aid flowing.
  • 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, thermoplastics
  • 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.
  • the filler solution may comprise a thermosetting polyurethane polymer based on a
  • extenders and/or crosslinkers are available commercially and
  • 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").
  • MDI 4,4'-diphenyl methane diisocyanate
  • TDI toluene diisocyanate
  • tetrahydrofuran polymers such as poly(tetramethylene oxide) ("PTMO").
  • PTMO poly(tetramethylene oxide)
  • 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
  • Suitable oils include, for example, soybean oils.
  • Filler solutions of the present invention may further include adjuvants and additives,
  • 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
  • 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.
  • means for improving biostability include the use of aliphatic macrodiol such as hydrogenated polybutadiene (HPDI).
  • HPDI hydrogenated polybutadiene
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Transplantation (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Vascular Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention se rapporte à un procédé et à un appareil (300) pour arthroplastie percutanée avec interposition de ballonnet. Ledit procédé consiste à pénétrer dans une articulation (10), à introduire un ballonnet dégonflé (200) dans l'articulation et à gonfler le ballonnet (300) avec une solution de remplissage. L'appareil de cette invention est un ballonnet (300) permettant de pratiquer une arthroplastie percutanée avec interposition, ledit ballonnet comportant une coque externe (210) et une solution de remplissage. Ce ballonnet (300) peut également comporter une solution de remplissage qui contient une composition de phases condensées, une composition gazeuse et tout mélange de gaz et de phases condensées.
PCT/US1999/024467 1998-10-21 1999-10-21 Appareil pour arthroplastie percutanee avec interposition de ballonnet WO2000023009A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2000576787A JP2002538850A (ja) 1998-10-21 1999-10-21 経皮挿入バルーン関節形成装置
CA002347977A CA2347977A1 (fr) 1998-10-21 1999-10-21 Appareil pour arthroplastie percutanee avec interposition de ballonnet
EP99956606A EP1123068A1 (fr) 1998-10-21 1999-10-21 Appareil pour arthroplastie percutanee avec interposition de ballonnet
AU13177/00A AU1317700A (en) 1998-10-21 1999-10-21 Apparatus for percutaneous interposition balloon arthroplasty

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10523198P 1998-10-21 1998-10-21
US60/105,231 1998-10-21

Publications (1)

Publication Number Publication Date
WO2000023009A1 true WO2000023009A1 (fr) 2000-04-27

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/024467 WO2000023009A1 (fr) 1998-10-21 1999-10-21 Appareil pour arthroplastie percutanee avec interposition de ballonnet

Country Status (5)

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EP (1) EP1123068A1 (fr)
JP (1) JP2002538850A (fr)
AU (1) AU1317700A (fr)
CA (1) CA2347977A1 (fr)
WO (1) WO2000023009A1 (fr)

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