CA2444557A1 - Inflatable device and method for reducing fractures in bone and in treating the spine - Google Patents

Inflatable device and method for reducing fractures in bone and in treating the spine Download PDF

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Publication number
CA2444557A1
CA2444557A1 CA002444557A CA2444557A CA2444557A1 CA 2444557 A1 CA2444557 A1 CA 2444557A1 CA 002444557 A CA002444557 A CA 002444557A CA 2444557 A CA2444557 A CA 2444557A CA 2444557 A1 CA2444557 A1 CA 2444557A1
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Canada
Prior art keywords
inflatable device
component
bone
sealant
inflatable
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Granted
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CA002444557A
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French (fr)
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CA2444557C (en
Inventor
Stuart Weikel
David C. Paul
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Synthes USA LLC
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Individual
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/025—Joint distractors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A61M29/02—Dilators made of swellable material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
    • A—HUMAN NECESSITIES
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    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
    • A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
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    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72—Intramedullary pins, nails or other devices
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    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7216—Intramedullary pins, nails or other devices for bone lengthening or compression
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    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
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    • 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
    • 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
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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
    • A—HUMAN NECESSITIES
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    • 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
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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
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Abstract

The present invention is directed to an inflatable device for use in restoring he anatomy of diseased or fractured bone. The inflatable device may be a balloon of varied size or shape to conform to the bone to be treated and may be deployed in any type of bone where collapsed fractures of cortical bone may be treated by restoring the bone from its inner surface. Once the bone has been sufficiently restored the balloons may be deflated and removed, or may remain inside the bone. The balloon may have multiple layers to provide desired surface characteristics, resistance to puncture and tearing, or other beneficial properties, as appropriate for the particular application of the device. The balloon comprises first and second components, wherein the first component is a barrier that forms a balloon wall and a second component is a reinforcing component extending over the first component. Making the reinforcing component as a braid can improve shape control in balloons having a tapered end or unsymmetrical geometry.

Claims (37)

1. An inflatable device for treating bone comprising first and second components, wherein the first component is a barrier that forms a balloon wall and the second component comprises a thread for reinforcing the wall, and wherein the second component is molded onto the first component.
2. The inflatable device of claim 1, wherein the second component is a woven braid.
3. The inflatable device of claim 2, wherein the woven braid forms a predetermined shape.
4. The inflatable device of claim 1, wherein the first component comprises an essentially inelastic material.
5. The inflatable device of claim 1, wherein the first component comprises an essentially semi-elastic material.
6. The inflatable device of claim 1, wherein the first component comprises an essentially elastic material.
7. The inflatable device of claim 1, wherein the second component comprises an essentially inelastic material.
8. The inflatable device of claim 1, further comprising a medicament.
9. The inflatable device of claim 8, wherein the medicament is disposed on an exterior surface of the balloon wall.
10. The inflatable device of claim 8, wherein the medicament is disposed on an interior surface of the balloon wall.
11. The inflatable device of claim 1, wherein the second component is at least partially resorbable.
12. The inflatable device of claim 1, wherein the first component is at least partially resorbable.
13. The inflatable device of claim 12, wherein the second component is at least partially resorbable.
14. The inflatable device of claim 12, wherein the first component further comprises a medicament that can be released as the first component is resorbed.
15. The inflatable device of claim 1, further comprising a coating on an exterior surface of the first component.
16. The inflatable device of claim 15, wherein the coating comprises a layer of hydrophobic material.
17. The inflatable device of claim 15, wherein the coating comprises a layer of hydrophillic material.
18. The inflatable device of claim 15, wherein the coating comprises a layer of material having a high friction surface.
19. The inflatable device of claim 15, wherein the coating comprises a layer of material having a low friction surface.
20. The inflatable device of claim 15, wherein the coating is resorbable.
21. The inflatable device of claim 15, wherein the coating covers essentially all of an exterior surface of the first component.
22. The inflatable device of claim 1, wherein the inflatable device is operably designed and configured to receive a filler material.
23. The inflatable device of claim 22, wherein the first component is operably designed and configured to lyse.
24. The inflatable device of claim 22, wherein at least one seam within the first and second components is operably designed and configured to fail under a triggering condition.
25. The inflatable device of claim 24, wherein the triggering condition is a pressure deferential between first and second sides of the balloon wall.
26. The inflatable device of claim 24, wherein the triggering condition comprises a chemical concentration proximate to a first side of the balloon wall.
27. The inflatable device of claim 24, wherein the at least one seam is resorbable.
28. The inflatable device of claim 24, wherein the at least one seam defines a region of the balloon wall.
29. A method for treating bone comprising:

creating a cavity in the treated area of the bone;

deploying an inflatable device inside the bone, said inflatable device having first and second components, wherein the first component is a barrier that forms a balloon wall and the second component comprises a thread for reinforcing the wall, and wherein the second component is molded onto the first component.
30. The method of claim 29, wherein the second component is a woven braid.
31. The method of claim 30, wherein the woven braid forms a predetermined shape.
32. The method of claim 29, further comprising the step of applying a sealant to the treated area prior to deployment of the inflatable device.
33. The method of claim 32, wherein the step of applying the sealant to the treated area comprises spray coating.
34. The method of claim 32, wherein the step of applying the sealant further comprises:

applying the sealant as a gel;

at least partially inflating the inflatable device within the treated area;

using the inflatable device to spread the sealant onto the treated area.
35. The method of claim 34, wherein the step of using the inflatable device to spread the sealant comprises rotating the inflatable device.
36. The method of claim 34, wherein the step of using the inflatable device to spread the sealant comprises moving the device along an axis in which the device is deployed into the treated area.
37. The method of claim 34, further comprising the step of gradually inflating the inflatable device while spreading the sealant onto the treated area.
CA2444557A 2001-04-19 2002-04-15 Inflatable device and method for reducing fractures in bone and in treating the spine Expired - Fee Related CA2444557C (en)

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US09/908,899 US6632235B2 (en) 2001-04-19 2001-07-20 Inflatable device and method for reducing fractures in bone and in treating the spine
PCT/US2002/011828 WO2002085227A1 (en) 2001-04-19 2002-04-15 Inflatable device and method for reducing fractures in bone and in treating the spine

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RU2003133668A (en) 2005-04-20
KR100918261B1 (en) 2009-09-18
IL158453A0 (en) 2004-05-12
CA2444557C (en) 2010-02-09
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JP2004526525A (en) 2004-09-02
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JP4436045B2 (en) 2010-03-24
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MY134183A (en) 2007-11-30
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US20020177866A1 (en) 2002-11-28
CN1518431A (en) 2004-08-04
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EP1379185B1 (en) 2014-03-26
WO2002085227A1 (en) 2002-10-31

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