US6113639A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Trial implant and trial implant kit for evaluating an intradiscal space
Assignee: RayMedica LLC
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Filing: 1999-03-23
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Granted: 2000-09-05
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Expires: 2019-03-23
Abstract
Abstract A trial implant for evaluating a size of an intradiscal space for subsequent implantation of a prosthetic spinal disc nucleus. The trial implant is comprised of an elongated central body and a retrieving body. The elongated body is formed from a rigid, surgically safe material and preferably has a volume less than a volume of a nucleus cavity portion of the intradiscal space. The retrieving body is associated with the central body and is configured to facilitate retrieval of the trial implant from an enclosed area, such as the nucleus cavity. A plurality of trial implants are included with a trial implant kit, with each of the plurality of trial implants housing a different size and/or shape. During use, the trial implant provides an indication as to whether a similarly sized prosthetic spinal disc nucleus will fit within a particular intradiscal space.
Inventors
- 👤 Charles D. Ray
- 👤 Robert L. Assell
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 05:14
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2/46; A61F2/4684; A61B; A61B50/00; A61B2050/005; A61B2050/0051; A61B2050/0056; A61B50/30; A61B50/33; A61F2/0095; A61F2/44; A61F2/441; A61F2/442; A61F2/4603; A61F2/4611; A61F2002/30001; A61F2002/30108; A61F2002/30199; A61F2002/30261; A61F2002/30263; A61F2002/30266; A61F2002/30316; A61F2002/30535; A61F2002/30604; A61F2002/30616; A61F2/30767; A61F2/30771; A61F2002/30772; A61F2002/30784; A61F2002/30785; A61F2002/444; A61F2002/448; A61F2002/4622; A61F2230/00; A61F2230/0063; A61F2230/0082; A61F2230/0084
Claims Analysis
Total Claims: 44
Claim 1
Independent Claim
114 words
A trial implant for evaluating a size of a nucleus cavity portion of an intradiscal space, the nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the trial implant comprising: an elongated central body defining a superior face, an inferior face, opposing side faces and opposing end faces, the central body being formed of a rigid, surgically safe material and having a volume less than a volume of a nucleus cavity; and a tab associated with the elongated central body for facilitating retrieval of the elongated central body from a nucleus cavity; wherein a combination of the central body and the tab is sized to be encompassed by the anulus.
Claim 2
Dependent Claim
114 words
A trial implant for evaluating a size of a nucleus cavity portion of an intradiscal space, the nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the trial implant comprising: an elongated central body defining a superior face, an inferior face, opposing side faces and opposing end faces, the central body being formed of a rigid, surgically safe material and having a volume less than a volume of a nucleus cavity; and a tab associated with the elongated central body for facilitating retrieval of the elongated central body from a nucleus cavity; wherein a combination of the central body and the tab is sized to be encompassed by the anulus.
Claim 3
Dependent Claim
17 words
The trial implant of claim 1, wherein the superior face and the inferior face are relatively smooth.
Claim 4
Dependent Claim
19 words
The trial implant of claim 2, wherein the opposing side faces and the opposing end faces are relatively smooth.
Claim 5
Dependent Claim
14 words
The trial implant of claim 1, wherein the elongated central body is substantially rectangular.
Claim 6
Dependent Claim
14 words
The trial implant of claim 1, wherein the elongated central body is substantially wedge-shaped.
Claim 7
Dependent Claim
57 words
The trial implant of claim 5, wherein the superior face and the inferior face extend in an angular fashion from a first one of the opposing side faces to a second one of the opposing side faces such that the first opposing side face has a height less than a height of the second opposing side face.
Claim 8
Dependent Claim
16 words
The trial implant of claim 6, wherein each of the opposing end faces is approximately trapezoidal.
Claim 9
Dependent Claim
54 words
The trial implant of claim 5, wherein the opposing end faces extend in an angular fashion from a first one of the opposing side faces to a second one of the opposing side faces such that the first opposing side face has a length less than a length of the second opposing side face.
Claim 10
Dependent Claim
17 words
The trial implant of claim 8, wherein the top face and the bottom face are approximately trapezoidal.
Claim 11
Dependent Claim
17 words
The trial implant of claim 1, where the elongated central body is made of an autoclave-sterilizable material.
Claim 12
Dependent Claim
23 words
The trial implant of claim 1, wherein the elongated central body has a height in the range of approximately 0.1 to 0.5 inch.
Claim 13
Dependent Claim
23 words
The trial implant of claim 1, wherein the elongated central body has a width in the range of approximately 0.2 to 0.5 inch.
Claim 14
Dependent Claim
24 words
The trial implant of claim 1, wherein the elongated central body has a maximum length in the range of approximately 0.3 to 1.7 inches.
Claim 15
Dependent Claim
18 words
The trial implant of claim 1, wherein the tab extends extending from one of the opposing end faces.
Claim 16
Dependent Claim
23 words
The trial implant of claim 14, further including: a second tab extending from one of the opposing end faces opposite the first tab.
Claim 17
Dependent Claim
12 words
The trial implant of claim 14, wherein the tab forms a hole.
Claim 18
Dependent Claim
18 words
The trial implant of claim 16, wherein the retrieving means further includes a thread secured to the tab.
Claim 19
Dependent Claim
92 words
A trial implant for evaluating a size of a nucleus cavity portion of an intradiscal space, the nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the trial implant comprising: an elongated body having a volume less than a volume of a nucleus cavity and being formed from a rigid, non-porous material; and a tab associated with the elongated body for facilitating retrieval of the elongated body from a nucleus cavity. wherein a combination of the elongated body and tab is sized to be encompassed by the anulus.
Claim 20
Dependent Claim
92 words
A trial implant for evaluating a size of a nucleus cavity portion of an intradiscal space, the nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the trial implant comprising: an elongated body having a volume less than a volume of a nucleus cavity and being formed from a rigid, non-porous material; and a tab associated with the elongated body for facilitating retrieval of the elongated body from a nucleus cavity. wherein a combination of the elongated body and tab is sized to be encompassed by the anulus.
Claim 21
Dependent Claim
28 words
The trial implant of claim 18, wherein the elongated body has a size and shape corresponding with a size and shape of an available prosthetic spinal disc nucleus.
Claim 22
Dependent Claim
16 words
The trial implant of claim 18, wherein the elongated body is made of an inert material.
Claim 23
Dependent Claim
16 words
The trial implant of claim 18, wherein the elongated body is made of a low-friction material.
Claim 24
Dependent Claim
16 words
The trial implant of claim 18, wherein the elongated body is made of a tough material.
Claim 25
Dependent Claim
12 words
The trial implant of claim 18, wherein the elongated body is polyvinylideneflouride.
Claim 26
Dependent Claim
16 words
The trial implant of claim 18, wherein the trial implant is made of an autoclave-sterilizable material.
Claim 27
Dependent Claim
121 words
A kit for use in evaluating a size of a nucleus cavity for receiving a prosthetic spinal disc nucleus, the nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the kit comprising: a container; a first trial implant maintained within the container, the first trial implant being formed of a rigid, surgically safe material and having a predetermined size and shape related to a size and shape of a nucleus cavity; and a second trial implant maintained within the container, the second trial implant being formed of a rigid, surgically safe material and having a predetermined size and shape, wherein the size of the first trial implant is different than the size of the second trial implant.
Claim 28
Dependent Claim
121 words
A kit for use in evaluating a size of a nucleus cavity for receiving a prosthetic spinal disc nucleus, the nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the kit comprising: a container; a first trial implant maintained within the container, the first trial implant being formed of a rigid, surgically safe material and having a predetermined size and shape related to a size and shape of a nucleus cavity; and a second trial implant maintained within the container, the second trial implant being formed of a rigid, surgically safe material and having a predetermined size and shape, wherein the size of the first trial implant is different than the size of the second trial implant.
Claim 29
Dependent Claim
23 words
The kit of claim 25, wherein the shape of the second trial implant is different than the shape of the first trial implant.
Claim 30
Dependent Claim
29 words
The kit of claim 25, wherein the shape and size of the first trial implant corresponds with a shape and size of an available first prosthetic spinal disc nucleus.
Claim 31
Dependent Claim
29 words
The kit of claim 27, wherein the shape and size of the second trial implant corresponds with a shape and size of an available second prosthetic spinal disc nucleus.
Claim 32
Dependent Claim
29 words
The kit of claim 25, wherein the container includes first indicia associated with the first trial implant, the first indicia indicative of a characteristic of the first trial implant.
Claim 33
Dependent Claim
29 words
The kit of claim 25, wherein the container further includes second indicia associated with the second trial implant, the second indicia identifying a characteristic of the second trial implant.
Claim 34
Dependent Claim
21 words
The kit of claim 25, wherein the first trial implant and the second trial implant are made of an autoclave-sterilizable material.
Claim 35
Dependent Claim
14 words
The kit of claim 25, wherein the container is made of an autoclave-sterilizable material.
Claim 36
Independent Claim
116 words
A method of evaluating a size of an intradiscal space for receiving a prosthetic spinal disc nucleus, the space including an intradiscal nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the method comprising: creating an opening in the anulus to provide access to the nucleus cavity; inserting a trial implant into the nucleus cavity through the opening, the trial implant being of a rigid, surgically safe material and having a predetermined size and shape; attempting to position the trial implant within a desired area of the nucleus cavity; determining whether the trial implant fits within the desired area of the nucleus cavity; and removing the trial implant from the nucleus cavity.
Claim 37
Independent Claim
116 words
A method of evaluating a size of an intradiscal space for receiving a prosthetic spinal disc nucleus, the space including an intradiscal nucleus cavity defined by an opposing pair of vertebral bodies and an anulus, the method comprising: creating an opening in the anulus to provide access to the nucleus cavity; inserting a trial implant into the nucleus cavity through the opening, the trial implant being of a rigid, surgically safe material and having a predetermined size and shape; attempting to position the trial implant within a desired area of the nucleus cavity; determining whether the trial implant fits within the desired area of the nucleus cavity; and removing the trial implant from the nucleus cavity.
Claim 38
Dependent Claim
27 words
The method of claim 33, wherein the size and shape of the trial implant correspond with a size and shape of an available prosthetic spinal disc nucleus.
Claim 39
Dependent Claim
21 words
The method of claim 33, wherein the desired area of the nucleus cavity is adjacent an anterior side of the anulus.
Claim 40
Dependent Claim
54 words
The method of claim 33, wherein the shape and size of the available prosthetic spinal disc nucleus dictates a desired orientation of the prosthetic spinal disc nucleus within the nucleus cavity upon implantation, and wherein attempting to position the trial implant includes: maneuvering the trial implant to a position corresponding with the desired orientation.
Claim 41
Dependent Claim
33 words
The method of claim 33, wherein determining whether the trial implant fits within the desired portion includes: evaluating whether the trial implant body is larger than the desired area of the nucleus cavity.
Claim 42
Dependent Claim
40 words
The method of claim 33, further including: selecting the trial implant from a plurality of trial implants based upon an estimate of the size of the desired area, wherein each of the plurality of trial implants has a different size.
Claim 43
Dependent Claim
17 words
The method of claim 33, further including: sterilizing the trial implant after removal from the nucleus cavity.
Claim 44
Dependent Claim
17 words
The method of claim 39, further including: reusing the trial implant to evaluate a second nucleus cavity.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2003-09-05 | 2004-03-06 | 2004-09-05 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-09-05 | 2008-03-06 | 2008-09-05 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-09-05 | 2012-03-06 | 2012-09-05 | $7700.00 | Window Closed / Lapsed |