Integrated electromagnetic implant guidance systems and methods of use for sacroiliac joint fusion
First Claim
1. A sacroiliac joint fusion system comprising:
- a) a joint implant comprising an electrode and a body including a distal end and a proximal end opposite the distal end, the electrode supported on the implant, wherein the electrode is located at a distal-inferior corner of the joint implant, the distal-inferior corner being defined at an intersection of a distal end surface and an inferior surface, the inferior surface extending between the proximal end and the distal end surface;
b) a delivery tool comprising an implant arm with a distal end configured to releasably couple to the proximal end of the body of the joint implant;
c) a nerve stimulating system configured to sense nerve proximity with the electrode; and
d) an electrical conductor pathway extending from the electrode along the implant and implant arm to the nerve stimulating system, the electrical conductor pathway placing the electrode and nerve stimulating system in electrical communication.
1 Assignment
0 Petitions
Accused Products
Abstract
A system for fixating a dysfunctional sacroiliac joint for SI joint fusion, the system including a sacroiliac joint implant, a sacroiliac joint screw or rod and a delivery tool configured for approaching a sacroiliac joint. The system may include an implant having a porous 3D matrix structure and may be manufactured by laser or electron beam additive manufacturing. The delivery tool may include a radiolucent material. The SI fusion system may further include custom sacroiliac joint implants, anchors, alignment tools or targeting arms manufactured for a particular patient. Pre-surgical imaging studies, including 3D rendering, and their interpretation may assist in planning desired trajectories, anchor dimensions and implant dimensions and may provide details specific to the manufacture of particular sacroiliac joint tools or implants and their implantation into the sacroiliac joint. The system may be configured for use with surgical robots and may include an integrated nerve monitoring and stimulation system.
164 Citations
113 Claims
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1. A sacroiliac joint fusion system comprising:
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a) a joint implant comprising an electrode and a body including a distal end and a proximal end opposite the distal end, the electrode supported on the implant, wherein the electrode is located at a distal-inferior corner of the joint implant, the distal-inferior corner being defined at an intersection of a distal end surface and an inferior surface, the inferior surface extending between the proximal end and the distal end surface; b) a delivery tool comprising an implant arm with a distal end configured to releasably couple to the proximal end of the body of the joint implant; c) a nerve stimulating system configured to sense nerve proximity with the electrode; and d) an electrical conductor pathway extending from the electrode along the implant and implant arm to the nerve stimulating system, the electrical conductor pathway placing the electrode and nerve stimulating system in electrical communication. - View Dependent Claims (2, 3, 4)
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5. A sacroiliac joint navigation and implant system configured to provide functional surgical guidance to an operator during a sacroiliac joint fusion procedure on a patient having a sacroiliac joint comprising a sacrum and an ilium, the system comprising:
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a) a joint implant comprising an electrode and a body including a distal end and a proximal end opposite the distal end, the electrode supported on the implant; b) a delivery tool comprising an implant arm including a distal end configured to releasably couple to the body of the joint implant; c) a controller unit configured to cause the electrode to emit a predetermined amount of energy; d) a data acquisition system comprising a second electrode, signal conditioning circuitry and a processing unit wherein the data acquisition system is configured to receive energy via the second electrode, convert physical parameters caused by the electrode to an electrical signal operable to enable the processing unit to process the signal to provide data comprising a relative location of the implant; e) a first electrical conductor pathway extending from the electrode along the joint implant and implant arm to the controller unit, the first electrical conductor pathway placing the electrode and controller unit in electrical communication; and f) a second electrical conductor pathway extending from the second electrode to the data acquisition system, the second electrical conductor pathway placing the second electrode, the signal conditioning circuitry, and the processing unit in electrical communication with one another, wherein the system is configured to transmit real-time functional guidance data to a surgical robot during the sacroiliac joint fusion procedure via at least one signal comprising a modulated parameter, the data being a result of signal conditioning and processing, the data comprising localization data being a correlate of the relative location of the implant, and wherein the energy emitted from the electrode is adjustable. - View Dependent Claims (6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29)
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30. A sacroiliac joint navigation and implant system configured to provide functional surgical guidance to an operator during a sacroiliac joint fusion procedure on a patient having a sacroiliac joint comprising a sacrum and an ilium, the system comprising:
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a) a joint implant comprising an electrode and a body including a distal end and a proximal end opposite the distal end, the electrode supported on the implant; b) a delivery tool comprising an implant arm including a distal end configured to releasably couple to the body of the joint implant; c) a controller unit configured to cause the electrode to emit a predetermined amount of energy; d) a data acquisition system comprising a second electrode, signal conditioning circuitry and a processing unit wherein the data acquisition system is configured to receive energy via the second electrode, convert physical parameters caused by the electrode to an electrical signal operable to enable the processing unit to process the signal to provide data comprising a relative location of the implant; e) a first electrical conductor pathway extending from the electrode along the joint implant and implant arm to the controller unit, the first electrical conductor pathway placing the electrode and controller unit in electrical communication; and f) a second electrical conductor pathway extending from the second electrode to the data acquisition system, the second electrical conductor pathway placing the second electrode, the signal conditioning circuitry, and the processing unit in electrical communication with one another, wherein the system is configured to transmit real-time functional guidance data to a surgical robot during the sacroiliac joint fusion procedure via at least one signal comprising a modulated parameter, the data being a result of signal conditioning and processing, the data comprising localization data being a correlate of the relative location of the implant, and wherein a parameter of the energy emitted from the electrode is adjustable. - View Dependent Claims (31, 32, 33)
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34. A sacroiliac joint navigation and implant system configured to provide functional surgical guidance to an operator during a sacroiliac joint fusion procedure on a patient having a sacroiliac joint comprising a sacrum and an ilium, the system comprising:
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a) a joint implant comprising an electrode and a body including a distal end and a proximal end opposite the distal end, the electrode supported on the implant; b) a delivery tool comprising an implant arm including a distal end configured to releasably couple to the body of the joint implant; c) a controller unit configured to cause the electrode to emit a predetermined amount of energy; d) a data acquisition system comprising a second electrode, signal conditioning circuitry and a processing unit wherein the data acquisition system is configured to receive energy via the second electrode, convert physical parameters caused by the electrode to an electrical signal operable to enable the processing unit to process the signal to provide data comprising a relative location of the implant; e) a first electrical conductor pathway extending from the electrode along the joint implant and implant arm to the controller unit, the first electrical conductor pathway placing the electrode and controller unit in electrical communication; and f) a second electrical conductor pathway extending from the second electrode to the data acquisition system, the second electrical conductor pathway placing the second electrode, the signal conditioning circuitry, and the processing unit in electrical communication with one another, wherein the system is configured to transmit real-time functional guidance data to a surgical robot during the sacroiliac joint fusion procedure via at least one signal comprising a modulated parameter, the data being a result of signal conditioning and processing, the data comprising localization data being a correlate of the relative location of the implant, wherein the data comprises allothetic sourced state feedback of the electrode, and wherein the delivery tool further comprises an anchor arm configured to be coupled to the implant arm resulting in an arrangement providing an idiothetic relational mapping source such that a member is deliverable to a sacroiliac joint region via the anchor arm into a position relative to a location of the joint implant. - View Dependent Claims (35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56)
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57. A sacroiliac joint navigation and implant system configured to provide functional surgical guidance to an operator during a sacroiliac joint fusion procedure on a patient having a sacroiliac joint comprising a sacrum and an ilium, the system comprising:
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a) a joint implant comprising an electrode and a body including a distal end and a proximal end opposite the distal end, the electrode supported on the implant; b) a delivery tool comprising an implant arm including a distal end configured to releasably couple to the body of the joint implant; c) a controller unit configured to cause the electrode to emit a predetermined amount of energy; d) a data acquisition system comprising a second electrode, signal conditioning circuitry and a processing unit wherein the data acquisition system is configured to receive energy via the second electrode, convert physical parameters caused by the electrode to an electrical signal operable to enable the processing unit to process the signal to provide data comprising a relative location of the implant; e) a first electrical conductor pathway extending from the electrode along the joint implant and implant arm to the controller unit, the first electrical conductor pathway placing the electrode and controller unit in electrical communication; and f) a second electrical conductor pathway extending from the second electrode to the data acquisition system, the second electrical conductor pathway placing the second electrode, the signal conditioning circuitry, and the processing unit in electrical communication with one another, wherein the electrode is located at a distal-inferior corner of the joint implant, the distal-inferior corner being defined at an intersection of a distal end surface and an inferior surface, the inferior surface extending between the proximal end and the distal end surface. - View Dependent Claims (58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71)
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72. A sacroiliac joint navigation and implant system configured to provide functional surgical guidance to an operator during a sacroiliac joint fusion procedure on a patient having a sacroiliac joint comprising a sacrum and an ilium, the system comprising:
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a) a joint implant comprising an electrode and a body including a distal end and a proximal end opposite the distal end, the electrode supported on the implant; b) a delivery tool comprising an implant arm including a distal end configured to releasably couple to the body of the joint implant; c) a controller unit configured to cause the electrode to emit a predetermined amount of energy; d) a data acquisition system comprising a second electrode, signal conditioning circuitry and a processing unit wherein the data acquisition system is configured to receive energy via the second electrode, convert physical parameters caused by the electrode to an electrical signal operable to enable the processing unit to process the signal to provide data comprising a relative location of the implant; e) a first electrical conductor pathway extending from the electrode along the joint implant and implant arm to the controller unit, the first electrical conductor pathway placing the electrode and controller unit in electrical communication; and f) a second electrical conductor pathway extending from the second electrode to the data acquisition system, the second electrical conductor pathway placing the second electrode, the signal conditioning circuitry, and the processing unit in electrical communication with one another, wherein an inferior side of the joint implant extends between the proximal and distal ends and the distal end comprises a distal-inferior corner defining an intersection of the distal end and the inferior side, wherein a radiopaque marker is positioned near the distal-inferior corner and is configured to assist in surgical navigation. - View Dependent Claims (73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85)
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86. A sacroiliac joint navigation and implant system configured to provide functional surgical guidance to an operator during a sacroiliac joint fusion procedure on a patient having a sacroiliac joint comprising a sacrum and an ilium, the system comprising:
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a) a joint implant comprising an electrode and a body including a distal end and a proximal end opposite the distal end, the electrode supported on the implant; b) a delivery tool comprising an implant arm including a distal end configured to releasably couple to the body of the joint implant; c) a controller unit configured to cause the electrode to emit a predetermined amount of energy; d) a data acquisition system comprising a second electrode, signal conditioning circuitry and a processing unit wherein the data acquisition system is configured to receive energy via the second electrode, convert physical parameters caused by the electrode to an electrical signal operable to enable the processing unit to process the signal to provide data comprising a relative location of the implant; e) a first electrical conductor pathway extending from the electrode along the joint implant and implant arm to the controller unit, the first electrical conductor pathway placing the electrode and controller unit in electrical communication; and f) a second electrical conductor pathway extending from the second electrode to the data acquisition system, the second electrical conductor pathway placing the second electrode, the signal conditioning circuitry, and the processing unit in electrical communication with one another, wherein the joint implant further comprises a length disposed between the distal and proximal ends;
an inner portion of the joint implant;
at least first, second, and third sides, each of the first, second, and third sides extending between the distal and proximal ends;
each of the first, second, and third sides comprising a plurality of struts defining a pattern of openings extending between groups of multiple struts of the plurality of struts, the openings extending into the inner portion;
wherein the first side is separated from the second side by a first junction, the second side is separated from the third side by a second junction, each the first and second junctions extending the length, andwherein a cross section transverse to the length of the implant is substantially non-circular such that it comprises at least three prominent apices and wherein each apex is comprised of a first, second, and third longitudinal strut each extending generally uninterrupted between the distal and proximal ends of the joint implant. - View Dependent Claims (87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110)
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111. A sacroiliac joint navigation and implant system configured to provide functional surgical guidance to an operator during a sacroiliac joint fusion procedure on a patient having a sacroiliac joint comprising a sacrum and an ilium, the system comprising:
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a) a joint implant comprising an electrode and a body including a distal end and a proximal end opposite the distal end, the electrode supported on the implant; b) a delivery tool comprising an implant arm including a distal end configured to releasably couple to the body of the joint implant; c) a controller unit configured to cause the electrode to emit a predetermined amount of energy; d) a data acquisition system comprising a second electrode, signal conditioning circuitry and a processing unit wherein the data acquisition system is configured to receive energy via the second electrode, convert physical parameters caused by the electrode to an electrical signal operable to enable the processing unit to process the signal to provide data comprising a relative location of the implant; e) a first electrical conductor pathway extending from the electrode along the joint implant and implant arm to the controller unit, the first electrical conductor pathway placing the electrode and controller unit in electrical communication; and f) a second electrical conductor pathway extending from the second electrode to the data acquisition system, the second electrical conductor pathway placing the second electrode, the signal conditioning circuitry, and the processing unit in electrical communication with one another, wherein the joint implant further comprises a length disposed between the distal and proximal ends;
an inner portion of the joint implant;
at least first, second, and third sides, each of the first, second, and third sides extending between the distal and proximal ends;
each of the first, second, and third sides comprising a plurality of struts defining a pattern of openings extending between groups of multiple struts of the plurality of struts, the openings extending into the inner portion;
wherein the first side is separated from the second side by a first junction, the second side is separated from the third side by a second junction, each the first and second junctions extending the length,wherein the implant further comprises a first junction having a first longitudinal strut and a second junction having a second longitudinal strut, each of the first and second longitudinal struts extending generally uninterrupted and generally parallel to each other along the length, wherein the plurality of struts defining a pattern of openings through the second side comprises a strut arrangement spaced along the length of the implant comprising different strut angles relative to a longitudinal axis of the first longitudinal strut and a longitudinal axis of the second longitudinal strut, wherein a sequence of openings of the pattern of openings comprises openings being at least in part polygonal in shape and wherein a first side of a first opening comprising the sequence is generally linear, parallel and adjacent the second longitudinal strut, the first side comprising a distal end and a proximal end, the distal end comprising a first strut and the proximal end comprising a second strut, each of the first and second strut coupled to and extend away from the second longitudinal strut towards and terminally coupled to the first longitudinal strut wherein the first and second strut comprise converging longitudinal axes; wherein a first side of a second opening comprising the next opening in the sequence adjacent the first opening is generally linear, parallel and adjacent the first longitudinal strut, the first side comprising a distal end and a proximal end, the distal end comprising the second strut and the proximal end comprising a third strut, the third strut coupled to and extend away from the first longitudinal strut towards and terminally coupled to the second longitudinal strut wherein the second and third strut comprise converging longitudinal axes; and wherein the implant further comprises a bore extending from an exterior surface of the proximal end into the inner region.
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112. A sacroiliac joint navigation and implant system configured to provide functional surgical guidance to an operator during a sacroiliac joint fusion procedure on a patient having a sacroiliac joint comprising a sacrum and an ilium, the system comprising:
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a) a joint implant comprising an electrode and a body including a distal end and a proximal end opposite the distal end, the electrode supported on the implant; b) a delivery tool comprising an implant arm including a distal end configured to releasably couple to the body of the joint implant; c) a controller unit configured to cause the electrode to emit a predetermined amount of energy; d) a data acquisition system comprising a second electrode, signal conditioning circuitry and a processing unit wherein the data acquisition system is configured to receive energy via the second electrode, convert physical parameters caused by the electrode to an electrical signal operable to enable the processing unit to process the signal to provide data comprising a relative location of the implant; e) a first electrical conductor pathway extending from the electrode along the joint implant and implant arm to the controller unit, the first electrical conductor pathway placing the electrode and controller unit in electrical communication; and f) a second electrical conductor pathway extending from the second electrode to the data acquisition system, the second electrical conductor pathway placing the second electrode, the signal conditioning circuitry, and the processing unit in electrical communication with one another, wherein the joint implant further comprises a length disposed between the distal and proximal ends;
an inner portion of the joint implant;
at least first, second, and third sides, each of the first, second, and third sides extending between the distal and proximal ends;
each of the first, second, and third sides comprising a plurality of struts defining a pattern of openings extending between groups of multiple struts of the plurality of struts, the openings extending into the inner portion;
wherein the first side is separated from the second side by a first junction, the second side is separated from the third side by a second junction, each the first and second junctions extending the length,wherein the implant further comprises a first junction having a first longitudinal strut and a second junction having a second longitudinal strut, each of the first and second longitudinal struts extending generally uninterrupted and generally parallel to one another along the length; wherein the plurality of struts defining a pattern of openings through the second side comprises a strut arrangement spaced along the length of the implant comprising repeating diagonal struts such that the diagonal struts extend at an angle between both the distal and proximal ends of the implant and the first and second longitudinal struts; wherein the implant further comprises a window extending into the inner portion substantially perpendicular to an extension of the openings comprising the pattern of openings, and wherein the window comprises a perimeter which is substantially larger than the openings comprising the pattern of openings, the window and openings comprising different shapes; and wherein the implant further comprises a first keel and second keel each coupled to the implant and each extending along the length between the distal and proximal ends of the implant, the first keel extending generally perpendicular to the length in a first direction and the second keel extending generally perpendicular to the length in a second direction generally opposite the first direction. - View Dependent Claims (113)
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Specification