KERF CRANIAL CLOSURE METHODS AND DEVICE
First Claim
Patent Images
1. A device for use in craniotomies comprising:
- a strip for laying into the kerf (gap) left by a craniotome blade;
wherein said strip leaves a substantially smooth contour with an outer surface of a cranium;
wherein the strip is sufficiently sponge-like and malleable to be compressed into a smaller space and held into place by compression forces created by the strips own tendency to expandwherein said strip is secured by the compression forces which reduce the tendency of the strips to fall into the kerf towards the dura or brain.
1 Assignment
0 Petitions
Accused Products
Abstract
The present disclosure is for a device for filling the gap (kerf) left in the repair of a craniotomy and the methods for using and manufacturing such a device. The kerf device may be a preparation of demineralized or partially demineralized bone or bone substitute formed into a malleable strip that can be pressed or molded into the opening in between the skull and bone flap in order to allow bone healing without a gap or indentation.
-
Citations
40 Claims
-
1. A device for use in craniotomies comprising:
-
a strip for laying into the kerf (gap) left by a craniotome blade; wherein said strip leaves a substantially smooth contour with an outer surface of a cranium; wherein the strip is sufficiently sponge-like and malleable to be compressed into a smaller space and held into place by compression forces created by the strips own tendency to expand wherein said strip is secured by the compression forces which reduce the tendency of the strips to fall into the kerf towards the dura or brain. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
-
-
13. A device for use in craniotomies comprising:
-
a plug for laying into the bur hole left by a drill or craniotome blade; wherein said plug leaves a substantially smooth contour with an outer surface of a cranium; wherein the plug is sufficiently sponge-like and malleable to be compressed into a smaller space and held into place by compression forces created by the plugs own tendency to expand; wherein said plug is secured the compression forces which reduce the tendency of the plug to fall into the bur hole towards the dura or brain. - View Dependent Claims (14, 15, 16, 17, 18, 19, 20)
-
-
21. A medical device for filling the gap (kerf) left in the repair of a craniotomy comprising:
-
a preparation of demineralized or partially demineralized bone or bone substitute; wherein said preparation is formed into a malleable strip; wherein said malleable strip is capable of being compressed or molded; wherein said malleable strip is compressed and placed in an opening between the skull and bone flap; wherein said compressed malleable strip once placed into said opening decompresses and expands to fill said opening; and wherein said device allows bone healing of said opening with minimal skull and bone flap gaps or indentations. - View Dependent Claims (22, 23, 24, 25, 26, 27)
-
-
28. A device for closing about a 2 mm to about a 5 mm gap in the cranial bone of a subject wherein the strip or plug is about 2 mm to 12 mm wide when in an uncompressed state and capable of being compressed to fill a kerf when in a compressed state;
- where said material is sufficiently elastic to decompress after being compressed to be placed in the gap so that said material expands to the width of the gap and results in a substantially secure placement of said material within said gap.
- View Dependent Claims (29, 30, 31)
-
32. A method for treating a cranial gap associated with a craniotomy in a subject comprising:
-
performing a craniotomy wherein bone is opened from its external surface to the level of the dura by placement of one or more bur holes; a bone flap is created so that bone may be displaced to provide access to the brain; wherein a trough is created around one or more bur holes to assist in the creation of the bone flap; wherein the trough in the bone around one or more bur holes is known as the kerf; wherein the a free bone flap portion is resecured to the surrounding cranium with a fixation device comprising titanium plates, screws and/or disk or post devices; wherein the kerf is filled with a device comprising a sufficient amount of material to bridge the gap between the free bone flap and the surrounding cranium; wherein the device comprises strips alone or strips and/or plugs; wherein a strip device when used may be formed into strips by squeezing the device materials between the user'"'"'s fingertips and fitting them into the gap or kerf;
thereby creating a substantially flush or smoother surface at the outer table of the bone as compared to the empty gap;wherein the plug device when used may be preformed and compressed and plugged into a bur hole;
thereby creating a substantially flush or smoother surface at the outer table of the bone as compared to the non-filled bur hole. - View Dependent Claims (33, 34)
-
-
35. A method for improving the clinical outcome of a craniotomy comprising:
- reducing the indentations or gaps left in the bone following a craniotomy;
wherein said indentations or gaps are filled with a device comprising a sufficient amount of material to substantially fill the indentations or gaps to the outer table of the bone; wherein the device comprises strips and/or plugs; wherein a strip device when used may be formed into strips by squeezing the device materials between the user'"'"'s fingertips and fitting them into the gap or kerf;
thereby creating a substantially flush or smoother surface at the outer table of the bone as compared to the empty gap;wherein the plug device when used may be preformed and compressed and plugged into a bur hole;
thereby creating a substantially flush or smoother surface at the outer table of the bone as compared to the non-filled bur hole. - View Dependent Claims (36, 37)
- reducing the indentations or gaps left in the bone following a craniotomy;
-
38. A kit for treating a cranial gap associated with a craniotomy in a subject comprising:
-
a strip or plug about 2 mm to 12 mm wide when in an uncompressed state and capable of being compressed to less than about 2 mm to about 5 mm wide when in the compressed state and a vial of infusion materials for the strip or plug comprising any of the following materials;
saline, all other materials listed above. - View Dependent Claims (39)
-
-
40. A kit for treating a cranial gap associated with a craniotomy in a subject comprising:
-
a preparation of demineralized or partially demineralized bone or bone substitute; wherein said preparation is formed into a malleable strip; and vial of infusion materials to be added to the strip comprising at least one of the following; a paste, gel, or other moldable or pourable liquid for the purpose of hardening the device into a solid matrix to create a hard surface or a watertight seal calcium-based materials (such as tricalcium phosphate) or demineralized bone matrix to increase the density of the strip and/or provide substrate for further bone growth; blood, blood derivative products, kerf bone, marrow, or stem cells used to promote osteogenesis and osteoinduction; biological growth factors in order to promote bone growth and ingrowth, such as via osteogenesis, osteoconduction, and/or osteoinduction; antibiotics, antibacterial agents and/or antiseptic agents in order to prevent bone flap infection.
-
Specification