Expandable fabric implant for stabilizing the spinal motion segment

• US 5,549,679 A
• Filed: 03/01/1995
• Issued: 08/27/1996
• Est. Priority Date: 05/20/1994
• Status: Expired due to Term

• Current Assignee: Spineology Incorporated
• Original Assignee: Stephen D. Kuslich
• Inventors: Kuslich, Stephen D.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): FOSSUM, LAURA J
• Application Number:
  US08/396,625
• Time in Patent Office: 545 Days
• Field of Search: 623/71, 606/51, 606/71, 606/80, 606/99
• US Class Current: 623/17.12
• 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 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 2017/1142 Purse-string sutures
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/30965 Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/4455 for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages intervertebral discs A61F2/442
• 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 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2002/2821 Bone stimulation by electromagnetic fields or electric current for enhancing ossification
• 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 2002/30014 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30242 spherical
• CPC Class Codes: A61F 2002/30245 Partial spheres
• CPC Class Codes: A61F 2002/30405 made by screwing complementary threads machined on the parts themselves
• CPC Class Codes: A61F 2002/30459 : stapled
• CPC Class Codes: A61F 2002/30461 : sutured, ligatured or stitched
• CPC Class Codes: A61F 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30589 : Sealing means
• CPC Class Codes: A61F 2002/30929 : having at least two superposed coatings
• CPC Class Codes: A61F 2002/30971 : Laminates, i.e. layered products
• CPC Class Codes: A61F 2002/30975 : made of two halves
• CPC Class Codes: A61F 2002/4435 : Support means or repair of the natural disc wall, i.e. annulus, e.g. using plates, membranes or meshes
• CPC Class Codes: A61F 2002/4495 : having a fabric structure, e.g. made from wires or fibres
• 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 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2220/0025 : Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0066 : stapled
• 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 2230/0071 : spherical
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0018 : differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated

Abstract

A method for stabilizing a spinal motion segment by boring and excising an opening in a disc nucleus, inserting a fabric bag having a pore size between about 0.25 and 5.0 mm, packing the bag with a graft medium until the bag is a rigid self-retaining shape, then closing the bag. The nucleus is excised by inserting an expandable cutting tool in order to cut an area greater than the access opening. A further spinal stabilization includes positioning a flexible bag containing graft medium against the exterior of the lamina bone of the adjacent vertebra. The exterior lamina bone is prepared by roughening to present a bleeding surface to hasten bone growth.

Claims

1. A method for stabilizing a spinal motion segment comprising the steps of:

(a) boring an opening into an annulus of a disc, said disc including a nucleus and end plates, each end plate being adjacent a vertebra, excising out at least a portion of the nucleus and a portion of the end plates of said disc and bone of adjacent vertebrae to said disc to expose healthy bone;

(b) inserting an expandable, empty fabric bag into said disc through said bored opening, said bag being formed of a fabric wall that includes a plurality of openings between about 0.25 to about 5.0 mm in diameter, said bag further including a mouth through which said bag may be filled;

(c) packing said bag through said mouth with material that will promote a bony or fibrous union between the vertebrae through said fabric wall, said packing causing said bag to inflate until it contacts said end plates forming a self-retaining rigid shape; and

(d) closing said bag mouth to prevent loss of said material.

2. A spinal stabilization method for a spine having contiguous vertebra with each of such vertebra including a body portion and with said body portions spaced apart by a layer of tissue, said method comprising the steps of:

forming an access opening into at least said layer of tissue with said access opening extending at least partially between said contiguous vertebra;

inserting an expandable cutting tool into said access opening with said cutting tool having a retracted size selected for said tool to pass into said opening, said cutting tool further having an expanded size selected for said tool to cut into an area greater than an area of said access opening;

removing at least a portion of said layer of tissue and said body portions with said expandable cutting tool to form an enlarged chamber disposed between said contiguous vertebra with said enlarge chamber having a cross-sectional area greater than a cross-sectional area of said access opening;

inserting a flexible, generally hollow, empty bag into said enlarged chamber, said bag having a plurality of pores sized between about 0.25 mm to about 5.0 mm and a fill opening;

filling said bag through said fill opening within said enlarged chamber with a graft medium until said enlarged chamber is filled by said filled bag forming

closing said fill opening.

3. A spinal stabilization method for a spine having contiguous vertebra with each of such vertebra including a body portion and with said body portions spaced apart by a layer of tissue, said method comprising the steps of:

opening tissue over adjacent vertebra to be fused together to expose adjacent vertebrae posterolaterally;

positioning at least one flexible, elongated bag containing graft medium against the exterior of the lamina bone of the adjacent vertebra, said bag having a plurality of pores sized between about 0.25 mm to about 5.0 mm to contain said graft medium; and

closing tissue over said adjacent vertebra such that at least one flexible bag remains firmly in contact with said bone to allow bone ingrowth and fusion across said bag.

4. The method of claim 3 wherein said bone is toughened to present a bleeding surface against which said at least one bag is positioned to hasten bone growth.