Inflatable device for use in surgical protocols relating to treatment of fractured or diseased bones

• US 5,827,289 A
• Filed: 06/05/1996
• Issued: 10/27/1998
• Est. Priority Date: 01/26/1994
• Status: Expired due to Term

• Current Assignee: Orthophoenix, LLC (Marathon Patent Group, Inc.)
• Original Assignee: Kyphon Incorporated (Medtronic Plc)
• Inventors: Scholten, Arie, Talmadge, Karen D., Reiley, Mark A.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): Shai, Daphna
• Application Number:
  US08/659,678
• Time in Patent Office: 874 Days
• Field of Search: 606/60, 606/62, 606/63, 606/86, 606/87, 606/89, 606/191, 606/192
• US Class Current: 606/86.00R
• 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 17/025 Joint distractors
• CPC Class Codes: A61B 17/7258 with laterally expanding parts, e.g. for gripping the bone
• CPC Class Codes: A61B 17/742 having one or more longitudinal elements oriented along or parallel to the axis of the neck
• CPC Class Codes: A61B 17/744 the longitudinal elements coupled to an intramedullary nail
• CPC Class Codes: A61B 17/8855 inflatable, e.g. kyphoplasty balloons
• 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 2002/4635 : 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 2025/105 : having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• 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 25/1011 : Multiple balloon catheters

Abstract

A balloon 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 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. 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

1. A device for insertion into a hip bone having an interior volume occupied, at least in part, by cancellous bone, the device comprising

a body having an axis and capable of expansion about the axis from a collapsed geometry, adapted for insertion into the interior volume, and an expanded geometry, adapted for compacting cancellous bone in the interior volume,

a first essentially inelastic band extending along the axis, and

a second essentially inelastic band extending along the axis spaced from the first essentially inelastic band, the first essentially inelastic band and the second essentially inelastic band having different axial lengths to restrain expansion such that the body bend along the axis during expansion.

2. A device according to claim 1

wherein the first and second essentially inelastic bands bias the body, when in the expanded geometry, toward a curved shape.

3. A device according to claim 1

wherein the first and second essentially inelastic bands are generally diametrically spaced along the axis.

4. A device according to claim 1

and further including at least one ring encircling the body about the axis and coupled to the first and second essentially inelastic bands.

5. A device according to claim 4

wherein the at least one ring comprises an essentially inelastic material.

6. A device according to claim 1

wherein the body comprises an essentially inelastic material.

7. A device according to claim 1

wherein the body comprises an essentially semi-elastic material.

8. A device according to claim 1

wherein the body comprises an essentially elastic material.

9. A device according to claim 1

and further including a catheter tube having a distal end, and

wherein the distal end carries the body.

10. A device according to claim 1

and further including a source of therapeutic substance arranged for compaction by the body into cancellous bone compressed by the body.