US6921403B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method and apparatus for spinal distraction and fusion
Assignee: Axiamed Inc
•
Filing: 2002-12-03
•
Granted: 2005-07-26
•
Expires: 2022-12-03
Abstract
Abstract The invention provides an implantable spinal distraction/fusion rod with varied thread pitch and diameters along different portions of its length that it is capable of distracting two or more vertebral bodies relative to each other and/or facilitating the procedure of fusing the vertebral bodies together from within the spine. The present invention also provides for methods of using the rod to distract and/or fuse two or more vertebral bodies from within the spine.
Inventors
- 👤 Andrew H. Cragg
- 👤 Robert L. Assell
- 👤 Eugene A. Dickhudt
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 18:51
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/56; A61B17/58; A61B17/88; A61B17/8802; A61B17/8805; A61B17/8819; A61B17/16; A61B17/1662; A61B17/1671; A61B17/17; A61B17/1739; A61B17/1757; A61B17/32; A61B17/320016; A61B17/32002; A61B17/68; A61B17/70; A61B17/7097; A61B17/7098; A61B17/8816; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2/44; A61F2/441; A61F2/4455; A61F2/4465; A61F2/46; A61F2/4601; A61F2/4603; A61F2/4611; A61B17/3205; A61B17/3207; A61B17/320725; A61B17/60; A61B17/66; A61B17/7055; A61B17/7061; A61B17/8811; A61B2017/00004; A61B17/00234; A61B2017/00238; A61B2017/00261; A61B2017/00535; A61B2017/00557; A61B2017/00681; A61B2017/00734; A61B2017/00831; A61B2017/00867; A61B17/28; A61B17/29; A61B2017/2901; A61B2017/2905; A61B2017/320004; A61B2017/320012; A61B2017/320733; A61B2017/564; A61F2/30721; A61F2/30723; A61F2/442; A61F2/28; A61F2002/2817; A61F2002/2835; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/30092; A61F2002/30108; A61F2002/30199; A61F2002/30224; A61F2002/30233; A61F2002/30235; A61F2002/30316; A61F2002/30535; A61F2002/30537; A61F2002/3055; A61F2002/30563; A61F2002/30593; A61F2002/30667; A61F2002/30677; A61F2/30767; A61F2/30771; A61F2002/30772; A61F2002/30774; A61F2002/30784; A61F2002/3085; A61F2002/30859; A61F2002/30878; A61F2002/30879; A61F2002/448; A61F2002/4625; A61F2002/4627; A61F2210/00; A61F2210/0014; A61F2230/00; A61F2230/0063; A61F2230/0069; A61F2310/00; A61F2310/00005; A61F2310/00011; A61F2310/00023; A61F2310/00389; A61F2310/00592; A61F2310/00796; A61F2310/00976; Y; Y10; Y10S; Y10S606/00; Y10S606/907; Y10S606/908
Claims Analysis
Total Claims: 79
Claim 1
Independent Claim
180 words
An axially-extending implantable rod for adjusting a distance between two adjacent vertebral bodies in a spine, said rod having an elongated body comprising: a first section near a leading end of the rod that has a first threading for directly engaging with a first vertebral body; a second section near a trailing end of the rod that has a second threading having a base diameter and a major diameter for directly engaging with a second vertebral body that is located proximally relative to the first vertebral body; and an intermediate section extending between the first section and the second section; at least one transverse aperture extending through the body in the intermediate section; wherein a first major diameter of the first threading is less than the base diameter of the second threading; wherein a first thread pitch in the first section is finer relative to a second thread pitch in the second section such that advancement of the first section distally into the first vertebral body by rotation causes an increase in distance between the first and second vertebral bodies.
Claim 2
Dependent Claim
180 words
An axially-extending implantable rod for adjusting a distance between two adjacent vertebral bodies in a spine, said rod having an elongated body comprising: a first section near a leading end of the rod that has a first threading for directly engaging with a first vertebral body; a second section near a trailing end of the rod that has a second threading having a base diameter and a major diameter for directly engaging with a second vertebral body that is located proximally relative to the first vertebral body; and an intermediate section extending between the first section and the second section; at least one transverse aperture extending through the body in the intermediate section; wherein a first major diameter of the first threading is less than the base diameter of the second threading; wherein a first thread pitch in the first section is finer relative to a second thread pitch in the second section such that advancement of the first section distally into the first vertebral body by rotation causes an increase in distance between the first and second vertebral bodies.
Claim 3
Dependent Claim
27 words
An implantable distraction device as in claim 1 , wherein the first major diameter is within the range of from about 10 mm to about 15 mm.
Claim 4
Dependent Claim
26 words
An implantable distraction device as in claim 2 , wherein the second major diameter is no greater than about 98 % of the first major diameter.
Claim 5
Dependent Claim
28 words
An implantable distraction device as in claim 1 , wherein the elongate body has a length within the range of from about 1.25 inches to about 2.25 inches.
Claim 6
Dependent Claim
35 words
An implantable distraction device as in claim 1 , wherein each of the proximal thread and the distal thread has an axial length within the range of from about 0.5 inches to about 1.25 inches.
Claim 7
Dependent Claim
29 words
An implantable distraction device as in claim 1 , wherein the intermediate section has an axial length within the range of from about 0.25 inches to about 0.5 inches.
Claim 8
Dependent Claim
16 words
An implantable distraction device as in claim 1 , wherein the elongate body comprises stainless steel.
Claim 9
Dependent Claim
15 words
An implantable distraction device as in claim 1 , wherein the elongate body comprises titanium.
Claim 10
Dependent Claim
17 words
An implantable distraction device as in claim 1 , wherein the elongate body comprises a bioabsorbable material.
Claim 11
Dependent Claim
29 words
An implantable distraction device as in claim 1 , wherein the elongate body comprises a lumen extending axially at least part way through the length of the elongate body.
Claim 12
Dependent Claim
25 words
An implantable distraction device as in claim 10 , wherein the elongate body further comprises a plurality of side apertures in communication with the lumen.
Claim 13
Dependent Claim
24 words
An implantable distraction device as in claim 1 , wherein each of the proximal thread and the distal thread extends counterclockwise around the body.
Claim 14
Dependent Claim
24 words
An implantable distraction device as in claim 1 , wherein each of the proximal thread and the distal thread extends clockwise around the body.
Claim 15
Dependent Claim
22 words
An implantable distraction device as in claim 1 , wherein each of the proximal thread and the distal thread are self tapping.
Claim 16
Dependent Claim
27 words
An implantable distraction device as in claim 2 , wherein the first major diameter is within the range of from about 12 mm to about 13 mm.
Claim 17
Dependent Claim
18 words
An implantable distraction device as in claim 1 , wherein the first major diameter is about 9 mm.
Claim 18
Dependent Claim
19 words
An implantable distraction device as in claim 1 , wherein the second pitch is less than the first pitch.
Claim 19
Dependent Claim
27 words
An implantable distraction device as in claim 1 , wherein the first pitch is within the range of from about 10 to about 15 turns per inch.
Claim 20
Dependent Claim
27 words
An implantable distraction device as in claim 1 , wherein the second pitch is within the range of from about 10 to about 20 turns per inch.
Claim 21
Dependent Claim
23 words
An implantable distraction device as in claim 1 , wherein the second pitch is at least about 105 % of the first pitch.
Claim 22
Dependent Claim
23 words
An implantable distraction device as in claim 1 , wherein the second pitch is at least about 110 % of the first pitch.
Claim 23
Dependent Claim
23 words
An implantable distraction device as in claim 1 , wherein the second pitch is at least about 125 % of the first pitch.
Claim 24
Dependent Claim
21 words
An implantable distraction device as in claim 1 , further comprising a releasable coupling, for releasably engaging a rotatable driver tool.
Claim 25
Independent Claim
149 words
A method of treating the spine, comprising the steps of: determining a desired change in disc height between targeted vertebral bodies, wherein the targeted vertebral bodies comprise a proximal body and a distal body; selecting an axially-extending rod with appropriate thread pitches in a distal section and a proximal section to achieve the desired change in height; accessing the targeted bodies by creating an axial bore that extends in the distal direction from a sacral target point to a disc space between the targeted bodies; extending the axial bore in the distal direction to create an extended portion of the axial bore, wherein the extended portion has a smaller diameter than the portion of the axial bore extending from the sacral target point to the disc space between the targeted bodies; advancing and implanting the selected rod into the targeted bodies to achieve the desired change in disc height.
Claim 26
Independent Claim
149 words
A method of treating the spine, comprising the steps of: determining a desired change in disc height between targeted vertebral bodies, wherein the targeted vertebral bodies comprise a proximal body and a distal body; selecting an axially-extending rod with appropriate thread pitches in a distal section and a proximal section to achieve the desired change in height; accessing the targeted bodies by creating an axial bore that extends in the distal direction from a sacral target point to a disc space between the targeted bodies; extending the axial bore in the distal direction to create an extended portion of the axial bore, wherein the extended portion has a smaller diameter than the portion of the axial bore extending from the sacral target point to the disc space between the targeted bodies; advancing and implanting the selected rod into the targeted bodies to achieve the desired change in disc height.
Claim 27
Dependent Claim
33 words
A method of treating the spine as in claim 24 , wherein the step of accessing the targeted vertebral bodies comprises identifying the sacral target point on the anterior surface of the sacrum.
Claim 28
Dependent Claim
37 words
A method of treating the spine as in claim 25 , wherein the step of extending the axial bore comprises forming a lumen from the sacral target point, through the proximal body and into the distal body.
Claim 29
Dependent Claim
29 words
A method of treating the spine as in claim 26 , wherein the step of advancing and implanting the selected rod comprises introducing the selected rod into the lumen.
Claim 30
Dependent Claim
51 words
A method of treating the spine as in claim 27 , wherein the step of advancing and implanting the selected rod comprises engaging a proximal end of the selected rod with respect to the proximal body, and engaging a distal end of the selected rod with respect to the distal body.
Claim 31
Dependent Claim
37 words
A method of treating the spine as in claim 28 , wherein the step of advancing and implanting the selected rod comprises manipulating the selected rod to increase a distance between the proximal and distal vertebral bodies.
Claim 32
Dependent Claim
23 words
A method of treating the spine as in claim 29 , wherein the lumen extends at least as far as the L4 vertebrae.
Claim 33
Dependent Claim
16 words
A method of treating the spine as in claim 30 , wherein the lumen is linear.
Claim 34
Dependent Claim
17 words
A method of treating the spine as in claim 27 , wherein the forming step comprises drilling.
Claim 35
Dependent Claim
32 words
A method of treating the spine as in claim 29 , additionally comprising the step of removing at least a part of a disc from between the proximal and distal vertebral bodies.
Claim 36
Dependent Claim
28 words
A method of treating the spine as in claim 29 , additionally comprising the step of removing an entire nucleus from between the proximal and distal vertebral bodies.
Claim 37
Dependent Claim
24 words
A method of treating the spine as in claim 29 , additionally comprising the step of introducing a bone growth facilitator through the lumen.
Claim 38
Dependent Claim
22 words
A method of treating the spine as in claim 35 , wherein the bone growth facilitator is introduced through the selected rod.
Claim 39
Dependent Claim
34 words
A method of treating the spine as in claim 29 , further comprising the step of removing the selected rod from the lumen after increasing the distance between the proximal and distal vertebral bodies.
Claim 40
Dependent Claim
34 words
A method of treating the spine as in claim 29 , further comprising the step of disengaging the selected rod from a selected rod delivery tool, to implant the selected rod within the lumen.
Claim 41
Dependent Claim
33 words
A method of treating the spine as in claim 24 , wherein the step of accessing the targeted vertebral bodies comprises identifying the sacral target point on the posterior surface of the sacrum.
Claim 42
Dependent Claim
43 words
A method of treating the spine as in claim 39 , wherein the step of extending the axial bore comprises forming a nonlinear lumen from the sacral target point, through the sacrum, through a proximal vertebral body and into a distal vertebral body.
Claim 43
Dependent Claim
29 words
A method of treating the spine as in claim 40 , wherein the step of advancing and implanting the selected rod comprises introducing the selected rod into the lumen.
Claim 44
Dependent Claim
51 words
A method of treating the spine as in claim 41 , wherein the step of advancing and implanting the selected rod comprises engaging a proximal end of the selected rod with respect to the proximal body, and engaging a distal end of the selected rod with respect to the distal body.
Claim 45
Dependent Claim
37 words
A method of treating the spine as in claim 42 , wherein the step of advancing and implanting the selected rod comprises manipulating the selected rod to increase a distance between the proximal and distal vertebral bodies.
Claim 46
Dependent Claim
23 words
A method of treating the spine as in claim 43 , wherein the lumen extends at least as far as the L4 vertebrae.
Claim 47
Dependent Claim
32 words
A method of treating the spine as hi claim 43 , additionally comprising the step of removing at least a part of a disc from between the proximal and distal vertebral bodies.
Claim 48
Dependent Claim
28 words
A method of treating the spine as in claim 43 , additionally comprising the step of removing an entire nucleus from between the proximal and distal vertebral bodies.
Claim 49
Dependent Claim
24 words
A method of treating the spine as in claim 43 , additionally comprising the step of introducing a bone growth facilitator through the lumen.
Claim 50
Dependent Claim
22 words
A method of treating the spine as in claim 47 , wherein the bone growth facilitator is introduced through the selected rod.
Claim 51
Dependent Claim
37 words
A method of treating the spine as in claim 24 , wherein the step of advancing and implanting the selected rod comprises rotating the selected rod to increase a distance between the proximal and distal vertebral bodies.
Claim 52
Dependent Claim
74 words
A method of treating the spine as in claim 24 , wherein the proximal section of the selected rod comprises a first thread having a first pitch and a first major diameter, wherein the distal section of the selected rod comprises a second thread having a second pitch and a second diameter, wherein the first pitch is different than the second pitch and the first major diameter is greater than the second major diameter.
Claim 53
Dependent Claim
29 words
A method of treating the spine as in claim 50 , wherein the first major diameter is within the range of from about 10 mm to about 15 mm.
Claim 54
Dependent Claim
28 words
A method of treating the spine as in claim 51 , wherein the second major diameter is no greater than about 98 % of the first major diameter.
Claim 55
Dependent Claim
30 words
A method of treating the spine as in claim 50 , wherein the selected rod has a length within the range of from about 1.25 inches to about 2.25 inches.
Claim 56
Dependent Claim
37 words
A method of treating the spine as in claim 50 , wherein each of the proximal section and the distal section has an axial length within the range of from about 0.5 inches to about 1.25 inches.
Claim 57
Dependent Claim
27 words
A method of treating the spine as in claim 50 , wherein the selected rod further comprises an intermediate section in between the proximal and distal sections.
Claim 58
Dependent Claim
30 words
A method of treating the spine as in claim 55 , wherein the intermediate section has an axial length within the range of about 0.25 inches to about 0.5 inches.
Claim 59
Dependent Claim
18 words
A method of treating the spine as in claim 50 , wherein the selected rod comprises stainless steel.
Claim 60
Dependent Claim
17 words
A method of treating the spine as in claim 50 , wherein the selected rod comprises titanium.
Claim 61
Dependent Claim
19 words
A method of treating the spine as in claim 50 , wherein the selected rod comprises a bioabsorbable material.
Claim 62
Dependent Claim
31 words
A method of treating the spine as in claim 50 , wherein the selected rod comprises a lumen extending axially at least part way through the length of the selected rod.
Claim 63
Dependent Claim
27 words
A method of treating the spine as in claim 60 , wherein the selected rod further comprises a plurality of side apertures in communication with the lumen.
Claim 64
Dependent Claim
27 words
A method of treating the spine as in claim 50 , wherein each of the first thread and the second thread extends counterclockwise around the selected rod.
Claim 65
Dependent Claim
27 words
A method of treating the spine as in claim 50 , wherein each of the first thread and the second thread extends clockwise around the selected rod.
Claim 66
Dependent Claim
24 words
A method of treating the spine as in claim 50 , wherein each of the first thread and the second thread are self tapping.
Claim 67
Dependent Claim
26 words
A method of treating the sine as in claim 50 , wherein diameter is within the range of from about 12 mm to about 13 mm.
Claim 68
Dependent Claim
20 words
A method of treating the spine as in claim 50 , wherein the second major diameter is about 9 mm.
Claim 69
Dependent Claim
21 words
A method of treating the spine as in claim 50 , wherein the second pitch is less than the first pitch.
Claim 70
Dependent Claim
29 words
A method of treating the spine as in claim 50 , wherein the first pitch is within the range of from about 10 to about 15 turns per inch.
Claim 71
Dependent Claim
29 words
A method of treating the spine as in claim 50 , wherein the second pitch is within the range of from about 10 to about 20 turns per inch.
Claim 72
Dependent Claim
25 words
A method of treating the spine as in claim 50 , wherein the second pitch is at least about 105 % of the first pitch.
Claim 73
Dependent Claim
25 words
A method of treating the spine as in claim 50 , wherein the second pitch is at least about 110 % of the first pitch.
Claim 74
Dependent Claim
25 words
A method of treating the spine as in claim 50 , wherein the second pitch is at least about 125 % of the first pitch.
Claim 75
Dependent Claim
27 words
A method of treating the spine as in claim 50 , wherein the selected rod further comprises a releasable coupling, for releasably engaging a rotatable driver tool.
Claim 76
Dependent Claim
29 words
A method of treating the spine as in claim 24 , additionally comprising the step of introducing a media between the proximal vertebral body and the distal vertebral body.
Claim 77
Dependent Claim
18 words
A method of treating the spine as in claim 74 , wherein the media comprises an osteogenic agent.
Claim 78
Dependent Claim
46 words
A method of treating the spine as in claim 24 , wherein the step of advancing and implanting the selected rod comprises rotating at least a portion of the selected rod in a first direction to increase a distance between the proximal and distal vertebral bodies.
Claim 79
Dependent Claim
47 words
A method of treating the spine as in claim 76 , wherein tho step of advancing and implanting the selected rod further comprises rotating at least a portion of the selected rod in a second direction to decrease the distance between the proximal and distal vertebral bodies.
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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) | 2008-07-25 | 2009-01-24 | 2009-07-26 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2012-07-25 | 2013-01-24 | 2013-07-26 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2016-07-25 | 2017-01-24 | 2017-07-26 | $7700.00 | Window Closed / Lapsed |