US20070066977A1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Exchange system for axial spinal procedures
Assignee: Trans1 Inc
•
Filing: 2006-08-09
•
Granted: —
•
Expires: 2026-08-09
Abstract
Abstract An exchange system is disclosed, for providing a protected path to a subcutaneous procedure site. An exchange cannula is provided with a central lumen, and a drill wire lumen that serves as a portal for a drill wire for coupling the assembly to bone. The wall thickness of the exchange cannula may be eccentric, to accommodate the drill wire lumen within the exchange cannula wall. A tensioning handle may be carried over the exchange cannula, for engaging adjacent tissue. The exchange cannula may have a proximal “T” handle. An exchange rod is movably positionable within the central lumen of the exchange cannula.
Inventors
- 👤 Robert Assell
- 👤 Stephen Ainsworth
- 👤 Andrew Cragg
- 👤 Eugene Dickhudt
- 👤 Michael Barnhouse
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 21:08
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/56; A61B17/58; A61B17/60; A61B17/68; A61B17/84; A61B17/842; A61B17/16; A61B17/17; A61B17/1739; A61B17/1757; A61B17/70; A61B17/88; A61B17/90; A61F; A61F2/00; A61F2/02; A61F2/30; A61F2/3094; A61F2/44; A61F2/4455; A61F2/4465; A61F2/46; A61F2/4603; A61F2/4611; A61B17/34; A61B17/3417; A61B17/3421; A61B17/8897; A61B17/00234; A61B2017/00238; A61B2017/00261; A61B2017/00526; A61B17/22; A61B2017/22038; A61B2017/22042; A61B2017/22044; A61F2002/30001; A61F2002/30003; A61F2002/3006; A61F2002/30092; A61F2002/30108; A61F2002/30199; A61F2002/30224; A61F2002/30233; A61F2/30767; A61F2/30771; A61F2002/30772; A61F2002/30784; A61F2002/3085; A61F2002/4631; A61F2002/4677; A61F2210/00; A61F2210/0014; A61F2230/00; A61F2230/0063; A61F2230/0069; A61F2310/00; A61F2310/00005; A61F2310/00011; A61F2310/00389
Claims Analysis
Total Claims: 84
Claim 1
Independent Claim
94 words
1 . An exchange system for increasing the cross sectional area of an access pathway through soft tissue to a surface of a bone, comprising: an elongate, tubular exchange bushing, having a proximal end, a distal end and a central lumen extending therethrough; and an elongate, tubular exchange cannula, having a proximal end, a distal end and a central lumen extending therethrough, the exchange cannula comprising a beveled distal end; a handle on the proximal end of the exchange-cannula; wherein the exchange bushing is axially slidable within the central lumen of the exchange cannula.
Claim 2
Dependent Claim
94 words
1 . An exchange system for increasing the cross sectional area of an access pathway through soft tissue to a surface of a bone, comprising: an elongate, tubular exchange bushing, having a proximal end, a distal end and a central lumen extending therethrough; and an elongate, tubular exchange cannula, having a proximal end, a distal end and a central lumen extending therethrough, the exchange cannula comprising a beveled distal end; a handle on the proximal end of the exchange-cannula; wherein the exchange bushing is axially slidable within the central lumen of the exchange cannula.
Claim 3
Dependent Claim
39 words
2 . An exchange system as in claim 1 , wherein the bevel is at an angle within the range of from about 20 degrees to about 70 degrees with respect to a longitudinal axis of the exchange cannula.
Claim 4
Dependent Claim
24 words
3 . An exchange system as in claim 1 , further comprising on the handle an indicium of the rotational orientation of the bevel.
Claim 5
Dependent Claim
50 words
4 . An exchange system as in claim 1 , wherein the exchange bushing further comprises a beveled distal end and the beveled distal end of the exchange cannula is at an angle that is substantially the same as the angle of the beveled distal end of the exchange bushing.
Claim 6
Dependent Claim
41 words
5 . An exchange system, comprising: an exchange rod; and an exchange cannula sub-assembly, wherein in the exchange cannula sub-assembly further comprises: an exchange cannula tube; a drill wire portal; a drill wire; a tensioning handle; a shoulder; and a retainer.
Claim 7
Dependent Claim
41 words
5 . An exchange system, comprising: an exchange rod; and an exchange cannula sub-assembly, wherein in the exchange cannula sub-assembly further comprises: an exchange cannula tube; a drill wire portal; a drill wire; a tensioning handle; a shoulder; and a retainer.
Claim 8
Dependent Claim
25 words
6 . An exchange system as in claim 5 , wherein the drill wire comprised in the exchange cannula sub-assembly further comprises a drill handle.
Claim 9
Dependent Claim
26 words
7 . An exchange system as in claim 5 , wherein the exchange cannula tube comprises a proximal end, a distal end, and a central lumen.
Claim 10
Dependent Claim
21 words
8 . An exchange system as in claim 7 , wherein the distal end comprises a bevel at its distal end.
Claim 11
Dependent Claim
38 words
9 . An exchange system as in claim 8 , wherein the bevel comprises a surface slanted relative to a longitudinal axis of the exchange cannula tube at an angle between about 20 degrees and about 70 degrees.
Claim 12
Dependent Claim
20 words
10 . An exchange system as in claim 7 , wherein the exchange cannula tube has an eccentric wall thickness.
Claim 13
Dependent Claim
24 words
11 . An exchange system as in claim 7 , wherein the exchange cannula tube has a length between about 6.00″ and about 10.00″
Claim 14
Dependent Claim
21 words
12 . An exchange system as in claim 7 , wherein the exchange cannula tube has a length of about 8.00″.
Claim 15
Dependent Claim
25 words
13 . An exchange system as in claim 7 , wherein the exchange cannula tube has an inner diameter between about 0.375″ and about 0.700″.
Claim 16
Dependent Claim
25 words
14 . An exchange system as in claim 7 , wherein the exchange cannula tube has an outer diameter between about 0.650″ and about 0.800″.
Claim 17
Dependent Claim
37 words
15 . An exchange system as in claim 5 , wherein the drill wire portal comprises a groove on the dorsal surface of the exchange cannula tube aligned with a longitudinal axis of the exchange cannula tube.
Claim 18
Dependent Claim
24 words
16 . An exchange system as in claim 15 , wherein the drill wire portal further comprises a hypo tube positioned in the groove.
Claim 19
Dependent Claim
42 words
17 . An exchange system as in claim 5 , wherein the drill wire portal is configured as an integral lumen formed just below the dorsal surface of the exchange cannula tube aligned with the longitudinal axis of the exchange cannula tube.
Claim 20
Dependent Claim
39 words
18 . An exchange system as in claim 5 , wherein the drill wire portal comprises a hypo tube seated along the dorsal surface of the exchange cannula tube aligned with the longitudinal axis of the exchange cannula tube.
Claim 21
Dependent Claim
20 words
19 . An exchange system as in claim 5 , wherein the tensioning handle further comprises a knob and threads.
Claim 22
Dependent Claim
21 words
20 . An exchange system as in claim 19 , wherein the knob comprises an interior slot to engage the retainer.
Claim 23
Dependent Claim
15 words
21 . An exchange system as in claim 19 , wherein the threads are coarse-pitch.
Claim 24
Dependent Claim
14 words
22 . An exchange system as in claim 19 wherein the threads are fine-pitch.
Claim 25
Dependent Claim
24 words
23 . An exchange system as in claim 5 , wherein the tensioning handle has a length ranging from about 3.00″ to about 6.00″.
Claim 26
Dependent Claim
26 words
24 . An exchange system as in claim 5 , wherein the tensioning handle has an outer diameter ranging from between about 0.8″ and about 1.0″.
Claim 27
Dependent Claim
26 words
25 . An exchange system as in claim 5 , wherein the tensioning handle has an inner diameter ranging from between about 0.650″ and about 0.800″.
Claim 28
Dependent Claim
25 words
26 . An exchange system as in claim 5 , wherein the shoulder has an inner diameter ranging from between about 0.600″ and about 0.750″.
Claim 29
Dependent Claim
25 words
27 . An exchange system as in claim 5 , wherein the shoulder has an outer diameter ranging from between about 0.900″ and about 1.00″.
Claim 30
Dependent Claim
24 words
28 . An exchange system as in claim 5 , wherein the shoulder has an axial length of between about 0.50″ and about 1.00″.
Claim 31
Dependent Claim
22 words
29 . An exchange system as in claim 5 , wherein the drill wire has a length between about 6.00″ and 16.00″.
Claim 32
Dependent Claim
25 words
30 . An exchange system as in claim 5 , wherein the drill wire has an outer diameter of between about 0.03″ and about 0.05″.
Claim 33
Dependent Claim
18 words
31 . An exchange system as in claim 5 , wherein the drill wire comprises a fluted portion.
Claim 34
Dependent Claim
26 words
32 . An exchange system as in claim 5 , wherein the drill wire comprises a flute disposed at a distal tip of the drill wire.
Claim 35
Dependent Claim
26 words
33 . An exchange system as in claim 32 , wherein the flute has a length between about 0.060″ (1.5 mm) and about 0.250″ (6 mm).
Claim 36
Dependent Claim
31 words
34 . An exchange system as in claim 32 , wherein the flute comprises a first substantially planar surface and a second substantially planar surface that intersect to form a corner.
Claim 37
Dependent Claim
41 words
35 . An exchange system as in claim 34 , wherein the corner extends along a line that is positioned at an angle relative to a longitudinal axis of the drill wire of between about 15 degrees and about 60 degrees.
Claim 38
Dependent Claim
34 words
36 . An exchange system as in claim 34 , wherein an angle between the first substantially planar surface and the second substantially planar surface is between about 30 degrees and about 120 degrees.
Claim 39
Dependent Claim
18 words
37 . An exchange system as in claim 5 , wherein the drill wire comprises a threaded portion.
Claim 40
Dependent Claim
18 words
38 . An exchange system as in claim 5 , wherein the drill wire comprises a trocar tip.
Claim 41
Dependent Claim
18 words
39 . An exchange system as in claim 5 , wherein the drill wire comprises a beveled tip.
Claim 42
Dependent Claim
26 words
40 . An exchange system as in claim 5 , wherein the exchange rod further comprises a distal end, a proximal end, and a central lumen.
Claim 43
Dependent Claim
21 words
41 . An exchange system as in claim 40 wherein the exchange rod further includes a handle at the proximal end.
Claim 44
Dependent Claim
25 words
42 . An exchange system as in claim 41 , wherein the handle includes visual indicia configured to indicate rotational orientation of the exchange rod.
Claim 45
Dependent Claim
24 words
43 . An exchange system as in claim 41 , wherein the handle includes grip features configured to aid manipulation of the exchange rod.
Claim 46
Dependent Claim
25 words
44 . An exchange system as in claim 40 , wherein the central lumen has an inner diameter ranging from about 0.10″ to about 0.20″.
Claim 47
Dependent Claim
25 words
45 . An exchange system as in claim 5 , wherein the outer diameter of the exchange rod ranges from about 0.375″ to about 0.700″.
Claim 48
Dependent Claim
32 words
46 . An exchange system as in claim 45 , wherein the outer diameter of the exchange rod is about 0.410″ at the distal end and about 0.560″ at the proximal end.
Claim 49
Dependent Claim
25 words
47 . An exchange system as in claim 45 , wherein the outer diameter of the exchange rod is about 0.375″ at the distal end.
Claim 50
Dependent Claim
25 words
48 . An exchange system as in claim 5 , wherein the length of the exchange rod ranges from between about 10.00″ and about 14.00″.
Claim 51
Dependent Claim
40 words
49 . An exchange system as in claim 5 , wherein the exchange rod is formed of a single part, having a proximal section and a distal section, and the distal section has a smaller diameter than the proximal section.
Claim 52
Dependent Claim
31 words
50 . An exchange system as in claim 5 , wherein at least one of the exchange rod and the exchange cannula tube is provided with a surfactant or hydrophilic coating.
Claim 53
Dependent Claim
43 words
51 . An exchange system as in claim 5 , wherein the following components are formed of metal or metal alloys: the exchange rod, the exchange cannula tube, the drill wire, the tensioning handle, the shoulder, the retaining means, and the drill handle.
Claim 54
Dependent Claim
23 words
52 . An exchange system as in claim 51 , wherein the metal or metal alloys comprise 300 series or 17-4 stainless steel.
Claim 55
Dependent Claim
47 words
53 . An exchange system as in claim 5 , wherein the radiolucency or radio-opaqueness of one or more of the following components is modified using contrast media: the exchange rod, the exchange cannula tube, the drill wire, the shoulder, the retaining means, and the drill handle.
Claim 56
Dependent Claim
29 words
54 . An exchange system as in claim 53 , wherein the contrast media is selected from the group consisting of: barium sulfate, iodine, stainless steel, Tantalum, and Titanium.
Claim 57
Dependent Claim
37 words
55 . An exchange system as in claim 5 , wherein the exchange rod comprises a proximal end, a distal end, and a tapered transition between a small diameter distal section and a larger diameter proximal section.
Claim 58
Dependent Claim
28 words
56 . An exchange system as in claim 55 , wherein the tapered transition is inclined at an angle with respect to a longitudinal axis of the rod.
Claim 59
Dependent Claim
22 words
57 . An exchange system as in claim 56 , wherein the angle is between about 20 degrees and about 70 degrees.
Claim 60
Dependent Claim
22 words
58 . An exchange system as in claim 56 , wherein the angle is between about 30 degrees and about 60 degrees.
Claim 61
Dependent Claim
41 words
59 . An exchange system as in claim 56 , wherein the exchange rod further includes a handle at a proximal end of the exchange rod, the handle comprising visual indicia configured to indicate a rotational orientation of the tapered transition.
Claim 62
Dependent Claim
36 words
60 . An exchange system as in claim 55 , wherein at least a portion of the small diameter distal section comprises a core formed of a first material that is overmolded with a second material.
Claim 63
Dependent Claim
26 words
61 . An exchange system as in claim 60 , wherein the first material comprises a metallic material and the second material comprises a polymeric material.
Claim 64
Dependent Claim
86 words
62 . A method of advancing a device along an access tract, comprising the steps of: removing a dilator sheath positioned over a guide wire extending between an access site and a target site on a bone; advancing a cannulated exchange bushing over the guide wire; advancing a tubular exchange cannula over the exchange bushing; removing the exchange bushing, leaving the exchange cannula in position along the access tract; and introducing the device through the exchange cannula and through the target site to a treatment site
Claim 65
Dependent Claim
86 words
62 . A method of advancing a device along an access tract, comprising the steps of: removing a dilator sheath positioned over a guide wire extending between an access site and a target site on a bone; advancing a cannulated exchange bushing over the guide wire; advancing a tubular exchange cannula over the exchange bushing; removing the exchange bushing, leaving the exchange cannula in position along the access tract; and introducing the device through the exchange cannula and through the target site to a treatment site
Claim 66
Dependent Claim
15 words
63 . A method as in claim 62 , wherein the device is an implant.
Claim 67
Dependent Claim
17 words
64 . A method as in claim 62 , wherein the device is a spinal fusion implant.
Claim 68
Dependent Claim
18 words
65 . A method as in claim 62 , wherein the device is a spinal motion preservation implant.
Claim 69
Dependent Claim
17 words
66 . A method as in claim 62 , wherein the device is a site preparation tool.
Claim 70
Dependent Claim
47 words
67 . A method as in claim 62 , wherein the device has a cross sectional area that is greater than the inside cross sectional area of the dilator sheath and the exchange cannula provides a protected portal for the surrounding tissue as the device is introduced
Claim 71
Dependent Claim
49 words
68 . A method as in claim 62 , wherein the device has a cross sectional area that is greater than the inside cross sectional area of the access track before dilation and the exchange cannula provides a protected portal for the surrounding tissue as the device is introduced.
Claim 72
Dependent Claim
17 words
69 . A method as in claim 62 , wherein the target site is on the sacrum.
Claim 73
Dependent Claim
55 words
70 . A method as in claim 62 , wherein the access tract has a longitudinal axis which intersects the surface of the bone at an angle, and the distal end of the exchange cannula is beveled at an angle that corresponds to the angle at which the axis intersects the surface of the bone.
Claim 74
Dependent Claim
81 words
71 . A method of advancing a device, implant, or other instrumentation along an axially oriented tract, comprising the steps of: advancing an exchange rod over an extended guide pin along the tract; advancing an exchange cannula sub-assembly over the exchange rod; securing the exchange cannula sub-assembly into a sacrum; removing the exchange rod from the tract; and inserting the device, implant, or instrumentation along the tract through a central lumen of an exchange cannula tube of the exchange cannula sub-assembly.
Claim 75
Dependent Claim
81 words
71 . A method of advancing a device, implant, or other instrumentation along an axially oriented tract, comprising the steps of: advancing an exchange rod over an extended guide pin along the tract; advancing an exchange cannula sub-assembly over the exchange rod; securing the exchange cannula sub-assembly into a sacrum; removing the exchange rod from the tract; and inserting the device, implant, or instrumentation along the tract through a central lumen of an exchange cannula tube of the exchange cannula sub-assembly.
Claim 76
Dependent Claim
35 words
72 . A method as in claim 71 , wherein advancing the exchange cannula sub-assembly further comprises applying torque to a tensioning handle of the exchange cannula sub-assembly to advance the sub-assembly through soft tissue.
Claim 77
Dependent Claim
36 words
73 . A method as in claim 71 , wherein advancing the exchange cannula sub-assembly further comprises placing a distal end of the exchange cannula tube over the exchange rod and seating it against the sacrum.
Claim 78
Dependent Claim
38 words
74 . A method as in claim 71 , wherein securing the exchange cannula sub-assembly further comprises tapping or torquing a drill wire placed on or within the dorsal surface of the exchange cannula tube into the sacrum.
Claim 79
Dependent Claim
31 words
75 . A method as in claim 74 , wherein the drill wire is tapped or torqued a distance of between about 5 mm and about 10 mm into the sacrum.
Claim 80
Dependent Claim
23 words
76 . A method as in claim 71 , wherein prior to inserting the device, implant, or instrumentation the guide pin is removed.
Claim 81
Dependent Claim
26 words
77 . A method as in claim 71 further comprising the step of enlarging the diameter of at least a portion of the exchange cannula tube.
Claim 82
Dependent Claim
25 words
78 . A method as in claim 71 wherein the tract comprises a longitudinal axis which intersects the surface of the sacrum at an angle.
Claim 83
Dependent Claim
56 words
79 . An exchange system, comprising: an exchange cannula sub-assembly, wherein in the exchange cannula sub-assembly further comprises: an exchange rod; an exchange cannula tube; a drill wire portal; a drill wire; a handle for the exchange cannula tube that is transverse to a longitudinal axis of the exchange cannula tube; a shoulder; and a retainer.
Claim 84
Dependent Claim
56 words
79 . An exchange system, comprising: an exchange cannula sub-assembly, wherein in the exchange cannula sub-assembly further comprises: an exchange rod; an exchange cannula tube; a drill wire portal; a drill wire; a handle for the exchange cannula tube that is transverse to a longitudinal axis of the exchange cannula tube; a shoulder; and a retainer.
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