US6602291B1 — Prosthetic spinal disc nucleus having a shape cha…

Claim 1

Independent Claim 118 words

A prosthetic spinal disc nucleus for implantation into a nucleus cavity of a spinal disc, the nucleus cavity having a height defined by an opposing pair of vertebrae and an outer periphery defined by an anulus, the prosthetic spinal disc nucleus comprising: a formed hydrogel core configured to expand from a dehydrated state to a hydrated state, the hydrogel core being configured to have a dehydrated shape in the dehydrated state that facilitates insertion of the prosthetic spinal disc nucleus through an opening in the anulus and being generally different from a hydrated shape of the hydrogel core in the hydrated state; and a constraining jacket surrounding the hydrogel core, the constraining jacket being flexible but substantially inelastic.

Claim 2

Dependent Claim 118 words

A prosthetic spinal disc nucleus for implantation into a nucleus cavity of a spinal disc, the nucleus cavity having a height defined by an opposing pair of vertebrae and an outer periphery defined by an anulus, the prosthetic spinal disc nucleus comprising: a formed hydrogel core configured to expand from a dehydrated state to a hydrated state, the hydrogel core being configured to have a dehydrated shape in the dehydrated state that facilitates insertion of the prosthetic spinal disc nucleus through an opening in the anulus and being generally different from a hydrated shape of the hydrogel core in the hydrated state; and a constraining jacket surrounding the hydrogel core, the constraining jacket being flexible but substantially inelastic.

Claim 3

Dependent Claim 29 words

The prosthetic spinal disc nucleus of claim 1 , wherein the constraining jacket has a generally fixed maximum volume that is less than the volume of the nucleus cavity.

Claim 4

Dependent Claim 15 words

The prosthetic spinal disc nucleus of claim 1 , wherein the dehydrated shape is streamlined.

Claim 5

Dependent Claim 26 words

The prosthetic spinal disc nucleus of claim 1 , wherein the dehydrated shape is substantially convexo-convex in transverse cross-section, whereas the hydrated shape is substantially plano-plano.

Claim 6

Dependent Claim 66 words

The prosthetic spinal disc nucleus of claim 1 , wherein the hydrogel core is defined by a leading end, a central portion, a trailing end and a height corresponding generally with a height of the nucleus cavity, and further wherein the dehydrated shape tapers in height from the central portion to the leading end for insertion of the leading end through the opening in the anulus.

Claim 7

Dependent Claim 26 words

The prosthetic spinal disc nucleus of claim 5 , wherein the leading end and the central portion of the hydrated shape have a relatively uniform height.

Claim 8

Dependent Claim 28 words

The prosthetic spinal disc nucleus of claim 5 , wherein the dehydrated shape includes a leading profile terminating at the leading end, the leading profile being generally conical.

Claim 9

Dependent Claim 36 words

The prosthetic spinal disc nucleus of claim 5 , wherein the dehydrated shape tapers in height from the central portion to the trailing end for insertion of the trailing end through the opening in the anulus.

Claim 10

Dependent Claim 81 words

The prosthetic spinal disc nucleus of claim 1 , wherein the hydrogel core is elongated and is defined by a leading end, a central portion, a trailing end and a length corresponding generally with a transverse width of the nucleus cavity as defined by the anulus, and further wherein the central portion of the dehydrated shape is curved to facilitate a transverse orientation of the prosthetic spinal disc nucleus in the nucleus cavity upon passage through the opening in the anulus.

Claim 11

Dependent Claim 20 words

The prosthetic spinal disc nucleus of claim 9 , wherein the central portion of the hydrated shape is generally linear.

Claim 12

Dependent Claim 40 words

The prosthetic spinal disc nucleus of claim 1 , wherein the constraining jacket has a generally fixed length, and further wherein the dehydrated shape of the hydrogel core has a length approximating the generally fixed length of the constraining jacket.

Claim 13

Independent Claim 120 words

A method of manufacturing a prosthetic spinal disc nucleus for implantation into a nucleus cavity of a spinal disc, the nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the method including: providing a hydrogel material that expands from a dehydrated state to a hydrated state; forming a hydrogel core from the hydrogel material, the hydrogel core being formed to have a first shape in the hydrated state; inserting the hydrogel core into a constraining jacket; and reshaping the hydrogel core to have a second shape in the dehydrated state, the second shape being different from the first shape, and wherein the hydrogel core will transition from the second shape to the first shape upon hydration.

Claim 14

Independent Claim 120 words

A method of manufacturing a prosthetic spinal disc nucleus for implantation into a nucleus cavity of a spinal disc, the nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the method including: providing a hydrogel material that expands from a dehydrated state to a hydrated state; forming a hydrogel core from the hydrogel material, the hydrogel core being formed to have a first shape in the hydrated state; inserting the hydrogel core into a constraining jacket; and reshaping the hydrogel core to have a second shape in the dehydrated state, the second shape being different from the first shape, and wherein the hydrogel core will transition from the second shape to the first shape upon hydration.

Claim 15

Dependent Claim 35 words

The method of claim 12 , wherein the hydrogel material has a shape memory attribute, and further wherein forming the hydrogel core includes: imparting the first shape into the shape memory of the hydrogel core.

Claim 16

Dependent Claim 16 words

The method of claim 12 , wherein reshaping the hydrogel core includes: dehydrating the hydrogel core.

Claim 17

Dependent Claim 57 words

The method of claim 12 , wherein reshaping the hydrogel core to have a second shape in the dehydrated state includes: forcing the hydrogel core to an elongated shape defined by a leading end, a trailing end and a central portion, the second shape of the hydrogel core tapering from the central portion to the leading end.

Claim 18

Dependent Claim 38 words

The method of claim 15 , wherein reshaping the hydrogel core to have a second shape further includes: forming the second shape of the hydrogel core such that a leading profile of the hydrogel core is generally conical.

Claim 19

Dependent Claim 33 words

The method of claim 15 , wherein reshaping the hydrogel core to have a second shape further includes: forming the second shape of the hydrogel core such that the central portion is curved.

Claim 20

Dependent Claim 54 words

The method of claim 12 , wherein the constraining jacket is substantially inelastic, having a generally fixed maximum length, and further wherein reshaping the hydrogel core to have a second shape includes: forming the second shape of the hydrogel core to have a length approximating the generally fixed maximum length of the constraining jacket.

Claim 21

Dependent Claim 35 words

The method of claim 12 , wherein forming a hydrogel core from the hydrogel material includes: pouring the hydrogel material, in a liquid state, into a mold having a shape corresponding with the first shape.

Claim 22

Dependent Claim 127 words

A prosthetic spinal disc nucleus for implantation into a nucleus cavity of a spinal disc, the nucleus cavity having a height defined by an opposing pair of end plates and an outer periphery defined by an anulus, the prosthetic spinal disc nucleus comprising: a formed hydrogel core configured to expand from a dehydrated state to a hydrated state, the hydrogel core having a streamlined shape in the dehydrated state and a wedge shape in the hydrated state, the hydrogel core being configured to transition from the streamlined shape to the wedge shape upon hydration; and a constraining jacket surrounding the hydrogel core, the constraining jacket being flexible but substantially inelastic and having a generally fixed maximum volume that is less than a volume of the nucleus cavity.

Claim 23

Dependent Claim 127 words

A prosthetic spinal disc nucleus for implantation into a nucleus cavity of a spinal disc, the nucleus cavity having a height defined by an opposing pair of end plates and an outer periphery defined by an anulus, the prosthetic spinal disc nucleus comprising: a formed hydrogel core configured to expand from a dehydrated state to a hydrated state, the hydrogel core having a streamlined shape in the dehydrated state and a wedge shape in the hydrated state, the hydrogel core being configured to transition from the streamlined shape to the wedge shape upon hydration; and a constraining jacket surrounding the hydrogel core, the constraining jacket being flexible but substantially inelastic and having a generally fixed maximum volume that is less than a volume of the nucleus cavity.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2006-08-04	2007-02-03	2007-08-05	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2010-08-04	2011-02-03	2011-08-05	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2014-08-04	2015-02-03	2015-08-05	$7700.00	Window Closed / Lapsed

Prosthetic spinal disc nucleus having a shape change characteristic

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