Inflatable device for use in surgical protocol relating to fixation of bone

• US 7,261,720 B2
• Filed: 10/07/2002
• Issued: 08/28/2007
• Est. Priority Date: 01/11/2002
• Status: Expired due to Fees

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated (Medtronic Plc)
• Inventors: Scholten, Arie, Boucher, Ryan P, Reiley, Mark A, Talmadge, Karen D, Ico, Cesar, Reiss, Paul, Salom, Nenita, Stevens, Sheila S, Follmer, Lulu
• Primary Examiner(s): Rodriguez; Cris
• Assistant Examiner(s): STOKES, CANDICE CAPRI
• Application Number:
  US10/265,922
• Publication Number:
  US 20040092948A1
• Time in Patent Office: 1,786 Days
• Field of Search: 606/90, 606/105, 606/191, 606/192, 600/37, 600/207, 600/201, 600/206, 600/208, 600/235, 601/151, 601/152, 601/153, 604/101.05, 604/103.09
• US Class Current: 606/105
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/7097 Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants disc prostheses made of inflatable chambers or pockets filled with fluid A61F2/441; replacing the nucleus pulposus A61F2002/444
• CPC Class Codes: A61B 17/72 Intramedullary pins, nails or other devices A61B17/744 takes precedence
• CPC Class Codes: A61B 17/7275 with expanding cylindrical parts
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• CPC Class Codes: A61B 17/8866 for gripping or pushing bones, e.g. approximators joint distractors A61B17/025
• CPC Class Codes: A61B 2010/0258 Marrow samples
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00544 pneumatically
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/0256 for the spine
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2050/3015 transparent
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2846 : Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects nets or sleeves applied to surface of endoprostheses A61F2/30907; bone plates A61B17/80; bone regeneration in dental surgery A61C8/0006
• CPC Class Codes: A61F 2/3601 : for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices non-prosthetic internal fixation devices for the femoral head or neck A61B17/74
• CPC Class Codes: A61F 2/389 : Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/44 : for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/441 : made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/4601 : for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4611 : of spinal prostheses
• CPC Class Codes: A61F 2002/2817 : Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2825 : Femur
• CPC Class Codes: A61F 2002/2828 : Femoral head
• CPC Class Codes: A61F 2002/2832 : Femoral neck
• CPC Class Codes: A61F 2002/2835 : Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/2853 : Humerus
• CPC Class Codes: A61F 2002/2871 : Radius
• CPC Class Codes: A61F 2002/2892 : Tibia
• CPC Class Codes: A61F 2002/30113 : circular
• CPC Class Codes: A61F 2002/30115 : circular-O-shaped
• CPC Class Codes: A61F 2002/30125 : elliptical or oval
• CPC Class Codes: A61F 2002/30131 : horseshoe- or crescent- or C-shaped or U-shaped
• CPC Class Codes: A61F 2002/30133 : kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/302 : toroidal, e.g. rings
• CPC Class Codes: A61F 2002/30225 : Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30228 : Cylinders of elliptical or oval basis
• CPC Class Codes: A61F 2002/30242 : spherical
• CPC Class Codes: A61F 2002/30245 : Partial spheres
• CPC Class Codes: A61F 2002/30253 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2002/30285 : rugby-ball-shaped
• CPC Class Codes: A61F 2002/30288 : bottle-shaped
• CPC Class Codes: A61F 2002/30308 : banana-shaped
• CPC Class Codes: A61F 2002/30313 : pear-shaped
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30462 : retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30586 : having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/30599 : stackable
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30686 : Devices for removing particulate debris from prosthetic joints
• CPC Class Codes: A61F 2002/30909 : Nets
• CPC Class Codes: A61F 2002/3611 : Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 : Necks
• CPC Class Codes: A61F 2002/4062 : Proximal or metaphyseal parts of shafts
• CPC Class Codes: A61F 2002/4217 : Calcaneum or calcaneus or heel bone
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4685 : by means of vacuum
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0063 : Three-dimensional shapes
• CPC Class Codes: A61F 2230/0065 : toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0076 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00353 : Bone cement, e.g. polymethylmethacrylate or PMMA
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61M 2025/1059 : having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties
• CPC Class Codes: A61M 2025/1072 : having balloons with two or more compartments
• CPC Class Codes: A61M 2210/02 : Bones
• CPC Class Codes: A61M 2210/1003 : Spinal column
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1006 : Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/1009 : Balloons anchored to a disc or plate
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A balloon for use in compressing cancellous bone and marrow (also known as medullary bone or trabecular bone). The balloon comprises an inflatable 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/or to restore the original position of the outer cortical bone, if fractured or collapsed. The balloon desirably incorporates restraints which inhibit the balloon from applying excessive pressure to various regions of the 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 the bone marrow. The balloon can be inserted quickly into a bone. The balloon can be made to have a suction catheter. The balloon can be used to form and/or enlarge a cavity or passage in a bone, especially in, but not limited to, vertebral bodies. Various additional embodiments facilitate directionally biasing the inflation of the balloon.

Claims

1. A method comprising

providing a system comprising a void creation device capable of being inserted through a percutaneous access path into a bone having cortical walls which enclose a cancellous bone volume, the void creation device including an expandable structure and including a first expandable region capable of expanding in the cancellous bone volume to compact a first region of the cancellous bone volume to form a first void, and a second expandable region spaced from the first expandable region and capable of expanding in the cancellous bone volume substantially independently of the first expandable region to compact a second region of the cancellous bone volume different than the first region of the cancellous bone volume to form a second void, and an expansion controller coupled to the expandable structure being capable of selective operation in a first condition to expand the first expandable region without substantially expanding the second expandable region and in a second condition to expand the second expandable region without substantially expanding the first expandable region,

inserting the void creation device into a bone through a percutaneous access path, and

operating the expansion controller to form at least one void in cancellous bone within the bone.

2. A method according to claim 1, wherein at least one of the expandable regions includes an internal restraints which allows for directional expansion of the respective expandable region.

3. A method according to claim 1

wherein the expansion controller is further capable of operation in a third condition to expand both the first and second expandable regions substantially simultaneously.

4. A method according to claim 1

wherein the expansion controller is capable of selectively collapsing the first expandable region without substantially collapsing the second expandable region, and vice versa.

5. A method according to claim 1

wherein the expansion controller is capable of selectively collapsing both the first expandable region and the second expandable region substantially simultaneously.

6. A method according to claim 1

wherein the bone comprises a vertebral body.

7. A method according to claim 1

wherein at least one of the first and second expandable regions comprises an inflatable body.

8. A method according to claim 7

wherein the expansion controller includes a valve controlling conveyance of an inflation medium to the inflatable body.

9. A method according to claim 1

wherein the expandable structure is elongated along an axis and includes proximal and distal end spaced apart along the axis, the first expandable region being located near the proximal end and the second expandable region being located near the distal end.

10. A method according to claim 9

wherein the expandable structure includes an intermediate section between the proximal and distal ends that does not significantly expand during expansion of the first and/or second expandable regions.

11. A method according to claim 10

wherein the first and second expandable regions, when substantially expanded, comprise lobes.

12. A method according to claim 1

further including placing a volume of filling material into the void.

13. A method according to claim 12

wherein the filling material hardens within the void.