CA2222144A1 - Expandable devices for treatment of fractured or diseased bone - Google Patents

Expandable devices for treatment of fractured or diseased bone

Info

Publication number
CA2222144A1
CA2222144A1 CA002222144A CA2222144A CA2222144A1 CA 2222144 A1 CA2222144 A1 CA 2222144A1 CA 002222144 A CA002222144 A CA 002222144A CA 2222144 A CA2222144 A CA 2222144A CA 2222144 A1 CA2222144 A1 CA 2222144A1
Authority
CA
Canada
Prior art keywords
balloon
bone
balloon body
therapeutic substance
inflating
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002222144A
Other languages
French (fr)
Other versions
CA2222144C (en
Inventor
Mark A. Reiley
Arie Scholten
Karen D. Talmadge
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic PLC
Original Assignee
Mark A. Reiley
Arie Scholten
Karen D. Talmadge
Kyphon Inc.
Medtronic Spine Llc
Kyphon Sarl
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 Mark A. Reiley, Arie Scholten, Karen D. Talmadge, Kyphon Inc., Medtronic Spine Llc, Kyphon Sarl filed Critical Mark A. Reiley
Priority to CA 2683004 priority Critical patent/CA2683004A1/en
Publication of CA2222144A1 publication Critical patent/CA2222144A1/en
Priority claimed from US08/788,786 external-priority patent/US6235043B1/en
Priority claimed from US10/044,843 external-priority patent/US20030032963A1/en
Application granted granted Critical
Publication of CA2222144C publication Critical patent/CA2222144C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

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    • 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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    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • 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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    • A61B17/74—Devices for the head or neck or trochanter of the femur
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    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/02—Bones
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
    • A61M2210/1003—Spinal column
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters

Abstract

A balloon (12) for use in compressing cancellous bone and marrow (also known as medullary bone or trabecular bone) against the inner cortex of bones whether the bones are fractured or not. The balloon comprises an inflatable, non-expandable balloon body for insertion into said bone. The body has a shape and size to compress at least a portion of the cancellous bone to form a cavity in the cancellous bone and to restore the original position of the outer cortical bone, if fractured or collapsed. The balloon is prevented from applying excessive pressure to the outer cortical bone. The wall or walls of the balloon are such that proper inflation of the balloon body is achieved to provide for optimum compression of all the bone marrow. The balloon is able to be folded so that it can be inserted quickly into a bone. The balloon can be made to have a suction catheter (16). It can also be coated with therapeutic substances. The main purpose of the balloon is the forming or enlarging of a cavity or passage in a bone, especially in, but not limited to, vertebral bodies. Another important purpose is to deliver therapeutic substances to bone in an improved way.

Claims (48)

1. A method for delivering a therapeutic substance to a treatment site with a bone comprising:
providing a hollow, collapsible, inflatable balloon;
applying a therapeutic substance to an outer surface of the balloon;
delivering the balloon into a space within the bone; and inflating the balloon to deliver the therapeutic substance to the bone.
2. The method of claim 1 further comprising:
inflating the balloon to a sufficient fluid pressure to compress at least a portion of the inner cancellous bone; and delivering the therapeutic substance to the compressed inner cancellous bone to directly incorporate the therapeutic substance into the bone.
3. The method of claim 1 further comprising inflating the balloon externally of the patient's body and applying the therapeutic substance to the outer surface of the inflated balloon.
4. The method of claim 3 further comprising collapsing the balloon and delivering the balloon and the therapeutic substance through a percutaneous penetration into the space within the bone.
5. The method of claim 1 wherein the applying step is carried out by delivering a gel formulation onto the outer surface of the balloon.
6. The method of claim 1 wherein the applying step is carried out by coating the balloon with a powder.
7. The method of claim 2 wherein the balloon forms a cavity within the bone, the method further comprising introducing a bone support material into the cavity while the balloon is inflated.
8. The method of claim 1 wherein the therapeutic substance comprises a filling material, the method further comprising filling cracks in fractured bone by inflating the balloon and delivering the filling material into the cracks.
9. The method of claim 1 wherein the therapeutic substance comprises a bone growth factor.
10. The method of claim 1 wherein the therapeutic substance comprises an antibiotic.
11. The method of claim 1 further comprising the step of inflating the balloon to a sufficient fluid pressure to compress at least 70% of the cancellous bone at the treatment site without applying excessive pressure to the bone.
12. The method of claim 1 further comprising the step of inflating the balloon to a sufficient fluid pressure to compress about 90% of the cancellous bone at the treatment site without applying excessive pressure to the bone.
13. A system for delivering a therapeutic substance to a treatment site within a bone comprising:

a hollow balloon body comprising a flexible, non-elastic material capable of inflation from a collapsed configuration to an expanded configuration, the balloon body having a predetermined size in the expanded configuration for compressing at least a portion of the inner cancellous bone, the non-elastic material inhibiting the balloon from being expanded beyond the predetermined size, the balloon body defining an outer surface and an inner passage for allowing an inflating fluid to pass into the body; and an applicator for applying a therapeutic substance to the outer surface of the balloon.
14. The system of claim 13 wherein the applicator comprises a container having an inner chamber for housing a reservoir of the therapeutic substance and a nozzle for dispensing a gel formulation onto the outer surface of the balloon.
15. The system of claim 13 wherein the applicator comprises a dry powder dispenser.
16. The system of claim 13 wherein the applicator comprises a dispersion device for aerosolizing a powered medicament onto the outer surface of the balloon.
17. The system of claim 13 wherein the predetermined size of the balloon body in the expanded configuration is selected to compress a substantial portion of the inner cancellous bone and to directly incorporate the therapeutic substance into the compressed cancellous bone.
18. The system of claim 17 further comprising means for delivering the balloon into a space within the bone and means for inflating the balloon within the space to deliver the therapeutic substance to the balloon.
19. The system of claim 13 wherein the therapeutic substance comprises a filling material for filling cracks in fractured bone by inflating the balloon and delivering the filling material into the cracks.
20. The system of claim 13 wherein the therapeutic substance comprises a bone growth factor.
21. The system of claim 13 wherein the therapeutic substance comprises an antibiotic.
22. The system of claim 13 wherein the balloon body, in the expanded configuration, is sized and shaped to compress at least 70% of the cancellous bone at the treatment site without applying substantial pressure to the bone.
23. The system of claim 13 wherein the balloon body, in the expanded configuration, is sized and shaped to compress about 90% of the cancellous bone at the treatment site without applying substantial pressure to the bone.
24. The balloon of claim 13 wherein the balloon body has substantially the same shape in the expanded and collapsed configurations.
25. A balloon for use in treating a patient's hip comprising:

a hollow elongate balloon body comprising a non-elastic material capable of inflation from a collapsed configuration to an expanded configuration, the balloon body defining an inner passage for allowing an inflating fluid to pass into the body; and wherein the balloon body has a predetermined size in the expanded configuration to extend from the femoral head, through the femoral neck, and into the proximal femoral diaphysis of the patient, the non-elastic material inhibiting the balloon from being expanded beyond the predetermined size of the balloon body.
26. The balloon of claim 25 wherein the balloon body includes an elongate distal portion sized, in the expanded configuration, to extend through the femoral neck into a portion of the femoral head, an elongate proximal portion transverse to the proximal portion and sized, in the expanded configuration, to extend into a portion of the femoral diaphysis, and an arcuate portion coupling the distal and proximal portions to each other.
27. The balloon of claim 26 further comprising means for biasing the proximal portion of the balloon body from an introducing configuration, where the proximal and distal portions are substantially parallel to each other, to an operative configuration, where the proximal portion extends into the proximal femoral diaphysis.
28. The balloon of claim 27 further comprising at least one restraint member for holding the proximal portion of the balloon in the introducing configuration when the balloon body is in the collapsed configuration, the restraint member being adapted to release the proximal portion when the balloon body is inflated into the expanded configuration.
29. The balloon of claim 25 further comprising one or more support members for holding the balloon body in the predetermined size and shape in the expanded configuration.
30. The balloon of claim 29 wherein the support members comprise one or more inelastic ring members surrounding the elongate balloon body and at least one inelastic axial band coupled to the ring members.
31. The balloon of claim 25 wherein the balloon body, in the expanded configuration, extends from about 0.3 to 0.7 cm from the end of the femoral head to about 5-7 cm past the lesser trochanter in the proximal femoral diaphysis.
32. The balloon of claim 25 wherein the balloon body, in the expanded configuration, has a length of about 10 to 20 cm and a diameter of about 1.0 to 2.5 cm.
33. A method for treating a patient's hip comprising:
forming a passage extending through the femoral neck into at least a portion of the femoral head;
positioning an elongate balloon body within the passage;
inflating the elongate balloon body to a sufficient fluid pressure to compress at least a portion of the inner cancellous bone; and forming a cavity with the balloon body as a function of the inflating step, the cavity extending from the femoral head, through the femoral neck, and downward into the proximal femoral diaphysis.
34. The method of claim 33 wherein the forming step includes drilling a substantially linear passage from the lateral femoral cortex, through the femoral neck, into the femoral head.
35. The method of claim 34 wherein the positioning step includes delivering the elongate balloon body through a percutaneous penetration into said linear passage.
36. The method of claim 34 further comprising, during the inflation step, biasing a proximal portion of the balloon body toward the proximal femoral diaphysis such that said proximal portion compresses inner cancellous bone within the proximal femoral diaphysis and moves into the proximal femoral diaphysis into a transverse orientation relative to a distal portion of the balloon body.
37. The method of claim 33 further comprising inhibiting the elongate balloon body from expanding beyond a predetermined size and shape to prevent the balloon from applying excess pressure on the cortical bone.
38. A system for temporarily supporting and strengthening a damaged bone comprising:
a hollow balloon body comprising a flexible, non-elastic material capable of inflation from a collapsed configuration to an expanded configuration, the balloon body having a predetermined size in the expanded configuration selected to compress at least a portion of the inner cancellous bone into the outer cortical bone to strength the outer cortical bone, the non-elastic material of the balloon body being capable of temporarily supporting the outer cortical bone when the balloon body is in the expanded configuration, the balloon body defining an inner passage for allowing an inflating fluid to pass into the body; and means for sealing the inner passage of the balloon body when the balloon is in the expanded configuration to provide a temporary support structure for the outer cortical bone.
39. The system of claim 38 wherein the sealing means comprises a plug sized to sealingly fit within the inner passage.
40. The system of claim 38 wherein the sealing means comprises a clip for closing the inner passage and fluidly isolating an inner chamber of the balloon.
41. The system of claim 38 wherein the balloon body forms a cavity by compressing the inner cancellous bone into the outer cortical bone, the sealing means being located externally of the cavity and internally within the patient.
42. The system of claim 38 wherein the damaged bone is a fractured cortical bone, the balloon body being capable of supporting the fractured cortical bone until said cortical bone heals.
43. A method for temporarily supporting and strengthening a fractured or collapsed bone comprising:
locating a hollow, balloon body within inner cancellous bone in the patient;
inflating the balloon body to a sufficient fluid pressure to compress at least a portion of the inner cancellous bone to form a cavity therein; and sealing the balloon body within the patient to provide a temporary structural support for the outer cortical bone.
44. The method of claim 45 further comprising compressing a sufficient portion of the inner cancellous bone into the outer cortical bone to stengthen the outer cortical bone after said cortical bone heals.
45. The method of claim 43 wherein the inflating step is carried out by delivering an inflation fluid through an inner passage into an inner chamber within the balloon body, the sealing step comprising applying a clip to the inner passage to fluidly isolate the inner chamber.
46. The method of claim 43 wherein the sealing step comprises sealing an inner passage of the balloon body with a plug.
47. The method of claim 43 further comprising, after the sealing step, allowing the balloon body to remain within the cavity to act as an internal cast while the cortical bone heals.
48. The method of claim 47 further comprising deflating the balloon and removing the balloon from the cavity.
CA002222144A 1994-01-26 1996-06-06 Expandable devices for treatment of fractured or diseased bone Expired - Fee Related CA2222144C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA 2683004 CA2683004A1 (en) 1995-06-07 1996-06-06 Expandable devices for treatment of fractured or diseased bone

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US18822494A 1994-01-26 1994-01-26
US48539495A 1995-06-07 1995-06-07
US08/485,394 1995-06-07
PCT/US1996/009933 WO1996039970A1 (en) 1994-01-26 1996-06-06 Improved inflatable device for use in surgical protocols relating to treatment of fractured or diseased bone
US08/788,786 US6235043B1 (en) 1994-01-26 1997-01-23 Inflatable device for use in surgical protocol relating to fixation of bone
US10/044,843 US20030032963A1 (en) 2001-10-24 2002-01-11 Devices and methods using an expandable body with internal restraint for compressing cancellous bone
US10/265,922 US7261720B2 (en) 2002-01-11 2002-10-07 Inflatable device for use in surgical protocol relating to fixation of bone

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA 2683004 Division CA2683004A1 (en) 1995-06-07 1996-06-06 Expandable devices for treatment of fractured or diseased bone

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CA2222144A1 true CA2222144A1 (en) 1996-12-19
CA2222144C CA2222144C (en) 2010-01-12

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CA002180556A Expired - Fee Related CA2180556C (en) 1994-01-26 1995-01-24 Improved inflatable device for use in surgical protocol relating to fixation of bone
CA002222144A Expired - Fee Related CA2222144C (en) 1994-01-26 1996-06-06 Expandable devices for treatment of fractured or diseased bone

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EP (3) EP0741547B1 (en)
JP (3) JP3333211B2 (en)
AT (1) ATE274847T1 (en)
AU (1) AU713014B2 (en)
CA (2) CA2180556C (en)
DE (1) DE69633286T2 (en)
NO (1) NO963115L (en)
NZ (2) NZ279442A (en)
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