WO2000049978A1 - Method of treating an intervertebral disk - Google Patents
Method of treating an intervertebral disk Download PDFInfo
- Publication number
- WO2000049978A1 WO2000049978A1 PCT/US2000/004380 US0004380W WO0049978A1 WO 2000049978 A1 WO2000049978 A1 WO 2000049978A1 US 0004380 W US0004380 W US 0004380W WO 0049978 A1 WO0049978 A1 WO 0049978A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- thermoplastic material
- injecting
- needle
- fibrosus
- annuius
- Prior art date
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4601—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
-
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
- A61B17/8822—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
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- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8833—Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
- A61B17/8836—Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means for heating, cooling or curing of bone cement or fluid fillers
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- A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
- A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
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Definitions
- This invention relates to surgical methods generally, and is more specifically
- the intervertebral disk is a disk with fibrous bands occupying the space
- the anatomy of the disk provides a cushion to allow motion
- the fibrosus band one upon the other, form the anterior portion of the spine.
- An nuisance fibrosus is the marginal or peripheral portion of an
- Intervertebral disks are prone to injury. Due to the low blood
- intervertebral disks are slowto heal, and may not materially heal.
- the nucleus pulposus can leak or
- the nucleus pulposus is a substance of jelly like
- the condition is usually
- Suppressive measures include steroidal injection, removal of the nucleus
- thermoplastic material must be pliable in its application, and non-flowing after
- the present invention is particularly directed to a process for treating the spine
- thermoplastic material heated to a predetermined
- thermoplastic or
- thermoplastic polymer material is any plastic or organic material that softens when
- thermoplastic material prior to injection is heated to a temperature sufficient for the material to flow under pressure into the
- thermoplastic material which has been found to be highly satisfactory is
- Gutta percha is a linear crystalline polymer which
- Normal body temperature is 37C and a suitable thermoplastic material
- a crystalline phase appears in two forms; an alpha phase and a beta
- the alpha form is the material that comes from the natural tree product.
- processed form is the beta form.
- gutta percha undergoes phase
- Gutta percha softens at a temperature above about 64C.
- gutta percha compound is dental gutta percha which contains by weight only about
- gutta percha is in the range of 15% to 40%.
- metals in the gutta percha compound are desirable for imaging such as X-rays while
- thermoplastic resins and waxes are desirable for obtaining an adequate flow of the thermoplastic
- Gutta percha provides the desired resiliency at body temperature and is
- Zinc oxide also provides an anti-inflammatory
- a mineral trioxide aggregate may be added to the gutta
- An injection device such as an injection gun, is utilized for heating and
- thermoplastic material under a predetermined pressure within the spine.
- the injection device may utilize a silver needle, encased in ceramics, of about 20 to
- thermoplastic material to be used may depend on such factors as the amount of thermoplastic material to be used
- thermoplastic e.g., a piston or plunger
- thermoplastic material is physiologically acceptable to the human body.
- thermoplastic material When the thermoplastic material is utilized to treat a ruptured annuius
- nucleus pulposus is removed and the material removed is replaced by
- thermoplastic material which sets at body temperature and provides
- thermoplastic material is injected within the
- thermoplastic material When the thermoplastic material is injected within the spine to reduce a
- the material is sequentially injected by a needle of the injection device into
- thermoplastic material into the annuius fibrosus of a spine.
- a further object of the present invention is to provide such a process in which
- thermoplastic material is heated to a predetermined temperature for flow into the
- Another object of the invention is to provide a process to treat a ruptured
- thermoplastic material into the annuius fibrosus to replace the nucleus pulposus.
- Figure 1 is a diagrammatic view of a ruptured/prolapsed annuius fibrosus
- Figure 2 is a sectional view of the ruptured annuius fibrosus showing leakage
- Figure 3 is a diagrammatic view illustrating injection of a thermoplastic
- Figure 4 shows the intervertebral disk after setting of the thermoplastic
- Figure 5 illustrates the abnormal curvature of the lower spine and the injection
- thermoplastic material into the curved concave portion of the spine
- Figure 6 is a perspective view of a modified injecting device for injecting a
- thermoplastic material within the spine thermoplastic material within the spine
- Figure 7 is a perspective view of a disk dilator.
- a portion of a spine is
- Disk 10 has an annuius fibrosus 12 which has ruptured at 14 resulting in a leakage or migration of nucleus pulposus 16 from the annuius fibrosus 12.
- sacral nerve is shown at 18 extending from the cauda eqina 19 and the migrating or
- nucleus pulposus 16 may result in a compression of nerve 18.
- thermoplastic material which does not flow at body temperature
- isolation is by means such as X-ray, MRI or other diagnostic imaging procedures
- the nucleus pulposus 16 removed is replaced with a thermoplastic material
- thermoplastic hardens at body temperature into a non-flowing resilient material.
- thermoplastic
- gutta percha or a gutta
- Gutta percha is a geometric isomer of natural rubber.
- elements may be added to the gutta percha to facilitate the binding properties and
- Dental gutta percha which may be utilized
- thermoplastic material 20 within
- an injection device or gun illustrated schematically at 22
- Injection gun 22 has a body 24 with a removable plunger 26 adapted to
- thermoplastic material 20 receives a cylindrical plug of the thermoplastic material 20.
- a heater 28 is provided
- thermoplastic material 20 to heat the thermoplastic material 20 and a heater control unit 30 having an
- adjustable temperature control knob 32 is provided with a temperature readout at 34.
- An injection needle 38 preferably formed of
- silver extends from body 24 and has a ceramic sheath 40 about a portion of needle
- a hand operated trigger 42 may be activated for forcing thermoplastic material 20 from the end of needle 38 upon heating of the thermoplastic material 20 to a
- thermoplastic material 20 in gun 22 a foot operated hydraulic pump
- a hydraulic cylinder 45 be provided at 44 to supply fluid through lines 46, 48 to a hydraulic cylinder 45.
- a suitable piston 51 may exert an axial force
- a hydraulic system is effective in providing
- Heated Gutta Percha System may be purchased from Obtura of Fenton, Missouri.
- Needle 38 preferably formed of silver may be of various diameters but will not
- Needle 38 may have a length of between
- thermoplastic material 20 centimeters and 30 centimeters.
- a plug or stick of the thermoplastic material 20 is
- thermoplastic material 20 is thermoplastic material 20
- thermoplastic material is required to be heated prior to injection to permit flow of the thermoplastic material.
- the degree to which the thermoplastic material 20 is heated may vary
- thermoplastic material is heated while utilizing a large diameter needle such as 1 centimeter in diameter with a relatively high axial force
- the highest temperature may be less than about 250C.
- optimum temperature is about 185C within an optimum range between about 150C
- thermoplastic material it is desirable for the thermoplastic material to have a viscosity
- thermoplastic material 20 After injection of the thermoplastic material 20 into the annuius
- the material flows to fill the entire void area of the annuius fibrosus
- thermoplastic material 20 cools
- thermoplastic material 20 tends to have a surface area of the thermoplastic material.
- the thermoplastic material 20 tends to have a surface area of the thermoplastic material.
- thermoplastic material is set. At normal human
- thermoplastic material is no longer moldable and is not flowing
- thermoplastic material 20 remains within the annuius
- thermoplastic material retain sufficient resilience in order to
- thermoplastic material 20 may be subsequently removed from the annuius fibrosus
- a spinal column is shown generally at 50 having
- spine 50 provides a concave curvature as shown in Figure 5 at which disks 34 are
- thermoplastic material 20 may be injected at intervertebral disks 54 progressively
- nucleus pulposus is not removed from the spine 50.
- the injected nucleus pulposus is not removed from the spine 50.
- thermoplastic material for the thermoplastic material to be injected.
- a modified injection device is shown generally at 60
- a suitable control knob 70 controls the temperature and a readout panel
- a generally cylindrical chamber or housing 72 adjacent heater 64 is provided
- Housing 72 has open
- Plug 74 may
- plugs 73 may be connected to heater 64 at one end and connected to a fluid
- a foot operated pedal 80 and a vent 82 is supplied through line 84 to pressure
- Concentric pistons 86 and 88 responsive to pressurized fluid in
- chamber 76 are provided to engage the end of thermoplastic plug 74 to urge plug 74
- pressure gauge 90 is provided to indicate the fluid pressure applied against
- thermoplastic plug 74 may be disposable with thermoplastic plug 74.
- housing 72 may be disposable with thermoplastic plug 74.
- heater 64 being of an increased length to receive the entire length of plug 74.
- Needle 62 is preferably about 6mm in diameter, and between about 20cm and
- thermoplastic material to purge 30 cm in length for maneuverability.
- needle 62 may be between about 5.65cc and 8.48cc dependent on the size of the
- thermoplastic material Approximately 15cc of thermoplastic material may be utilized for injection
- Cylindrical plug 74 may have a total volume of 21cc with a
- Needle 62 for heating of the projecting needle 62.
- Needle 62 may be formed of a ceramic
- Needle 62, heater 64 and housing 72 may comprise separate injection
- the fluid for the hydraulic system for fluid cylinder 76 may be water
- a disk dilator assembly generally
- an inert fluid such as saline
- Disk dilator assembly 100 is
- detachable balloon dilator sleeve 106 extends about the extending end of needle
- Piston 108 is effective to pressurize the fluid for
- thermoplastic material of the compound by weight is the preferred thermoplastic material, it is understood that other types of thermoplastic material may be suitable if in a non-flowing state
- elements may be added to the gutta percha compound in various percentages.
- thermoplastic material other types of injection devices for heating the thermoplastic
- thermoplastic material for molding thermoplastic material into thermoplastic material and for applying an axial force against the thermoplastic material
- injection may be provided.
- various devices may be provided for injection.
- thermoplastic material prior to injection and for pressurizing the thermoplastic material
- thermoplastic material for controlled flow of the thermoplastic material through an
Abstract
Description
Claims
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU34983/00A AU3498300A (en) | 1999-02-22 | 2000-02-18 | Method of treating an intervertebral disk |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/255,372 | 1999-02-22 | ||
US09/255,372 US6206921B1 (en) | 1999-02-22 | 1999-02-22 | Method of replacing nucleus pulposus and repairing the intervertebral disk |
US09/274,217 US6183518B1 (en) | 1999-02-22 | 1999-03-23 | Method of replacing nucleus pulposus and repairing the intervertebral disk |
US09/274,217 | 1999-03-23 | ||
US09/456,375 US6264659B1 (en) | 1999-02-22 | 1999-12-08 | Method of treating an intervertebral disk |
US09/456,375 | 1999-12-08 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2000049978A1 true WO2000049978A1 (en) | 2000-08-31 |
Family
ID=46203808
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2000/004380 WO2000049978A1 (en) | 1999-02-22 | 2000-02-18 | Method of treating an intervertebral disk |
Country Status (2)
Country | Link |
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AU (1) | AU3498300A (en) |
WO (1) | WO2000049978A1 (en) |
Cited By (38)
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WO2002054978A2 (en) | 1999-08-18 | 2002-07-18 | Intrinsic Orthopedics Inc | Devices and method for nucleus pulposus augmentation and retention |
US6592625B2 (en) | 1999-10-20 | 2003-07-15 | Anulex Technologies, Inc. | Spinal disc annulus reconstruction method and spinal disc annulus stent |
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WO2006129027A2 (en) * | 2005-06-02 | 2006-12-07 | Spinevision | Invertebral prosthetic disc nucleus and vertebroplasty prosthesis |
WO2010008814A3 (en) * | 2008-06-24 | 2010-07-08 | Carefusion 2200, Inc. | Apparatus and method for optimizing reaction time for curable material |
US7846208B2 (en) | 1999-10-20 | 2010-12-07 | Anulex Technologies, Inc. | Spinal disc annulus reconstruction method and deformable spinal disc annulus stent |
US8414509B2 (en) | 2002-01-23 | 2013-04-09 | The Regents Of The University Of California | Implantable thermal treatment method and apparatus |
US8450288B2 (en) | 2001-11-01 | 2013-05-28 | Spine Wave, Inc. | System and method for the pretreatment of the endplates of an intervertebral disc |
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US8992522B2 (en) | 2002-09-30 | 2015-03-31 | Relievant Medsystems, Inc. | Back pain treatment methods |
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US9039741B2 (en) | 2005-12-28 | 2015-05-26 | Intrinsic Therapeutics, Inc. | Bone anchor systems |
US9039701B2 (en) | 2008-09-26 | 2015-05-26 | Relievant Medsystems, Inc. | Channeling paths into bone |
US9095442B2 (en) | 1999-10-20 | 2015-08-04 | Krt Investors, Inc. | Method and apparatus for the treatment of the intervertebral disc annulus |
US9114025B2 (en) | 1999-10-20 | 2015-08-25 | Krt Investors, Inc. | Methods and devices for spinal disc annulus reconstruction and repair |
US9192372B2 (en) | 2008-10-14 | 2015-11-24 | Krt Investors, Inc. | Method for the treatment of tissue |
US9226832B2 (en) | 2007-09-07 | 2016-01-05 | Intrinsic Therapeutics, Inc. | Interbody fusion material retention methods |
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US9675347B2 (en) | 1999-10-20 | 2017-06-13 | Krt Investors, Inc. | Apparatus for the treatment of tissue |
US9706947B2 (en) | 1999-08-18 | 2017-07-18 | Intrinsic Therapeutics, Inc. | Method of performing an anchor implantation procedure within a disc |
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US10179012B2 (en) | 2013-01-28 | 2019-01-15 | Cartiva, Inc. | Systems and methods for orthopedic repair |
US10390877B2 (en) | 2011-12-30 | 2019-08-27 | Relievant Medsystems, Inc. | Systems and methods for treating back pain |
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US9333087B2 (en) | 1999-08-18 | 2016-05-10 | Intrinsic Therapeutics, Inc. | Herniated disc repair |
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