Curved bone access systems
Described herein are various implementations of systems and methods for accessing and modulating tissue (for example, systems and methods for accessing and ablating nerves or other tissue within or surrounding a vertebral body to treat chronic lower back pain). Assessment of vertebral endplate degeneration or defects (e.g., pre-Modic changes) to facilitate identification of treatment sites and protocols are also provided in several embodiments. Several embodiments comprise the use of biomarkers to confirm or otherwise assess ablation, pain relief, efficacy of treatment, etc. Some embodiments include robotic elements for, as an example, facilitating robotically controlled access, navigation, imaging, and/or treatment.
1. A system configured to provide curved access within bone, the system comprising:
a cannula comprising a proximal handle with a curved insertion slot and a distal polymeric tube,
wherein the distal polymeric tube comprises a curved distal end portion having a preformed curvature but configured to bend when placed under constraint;
a stylet comprising a proximal handle and a distal elongate shaft,
wherein the distal elongate shaft comprises a curved distal end portion having a preformed curvature but configured to bend when placed under constraint and a distal channeling tip,
wherein a length of the curved distal end portion of the distal elongate shaft proximal to the distal channeling tip comprises a cross-section circumference profile that is less than a full cross-section circumference profile such that there is a larger gap between an outer cross-sectional dimension of the curved distal end portion of the distal elongate shaft and the inner diameter of the curved distal end portion of the cannula along the length,
wherein the cross-section circumference profile is asymmetric,
wherein a maximum vertical cross-sectional dimension of the length of the curved distal end portion of the stylet is between 40% and 80% of a maximum cross-sectional dimension of proximal and distal regions bordering the length of the curved distal end portion of the stylet, and
wherein the proximal handle of the stylet is configured to actuate so as to cause proximal axial retraction of the stylet with respect to the cannula when the proximal handle of the stylet is engaged with the proximal handle of the cannula.
2. The system of claim 1 :
wherein the cross-section circumference profile comprises a “D” shape,
wherein the cross-section circumference profile causes the curved distal end portion of the distal elongate shaft to primarily bend inward,
wherein a maximum vertical cross-sectional dimension of the length of the curved distal end portion of the distal elongate shaft is between 50% and 70% of a maximum cross sectional dimension of proximal and distal regions bordering the length of the curved distal end portion, and
wherein a radius of curvature of the curved distal end portion of the distal elongate shaft is between 11.5 mm and 15 mm.
3. The system of claim 1 , wherein an upper surface of the length of the curved distal end portion is generally flat.
4. The system of claim 1 , wherein the curved distal end portion of the distal elongate shaft is constructed such that the preformed curvature of the curved distal end portion of the distal elongate shaft remains relatively consistent and reproducible across a variety of bone densities.
5. The system of claim 1 , wherein a maximum vertical cross-sectional dimension of the length of the curved distal end portion of the distal elongate shaft is between 50% and 70% of a maximum cross sectional dimension of proximal and distal regions bordering the length of the curved distal end portion.
6. The system of claim 1 , wherein a radius of curvature of the curved distal end portion of the distal elongate shaft is between 11.5 mm and 15 mm.
7. The system of claim 1 , wherein the stylet is comprised of nitinol material.
8. A system configured to provide curved access within bone, the system comprising:
a cannula comprising a proximal handle with a curved insertion slot and a distal polymeric tube,
wherein the distal polymeric tube comprises a curved distal end portion having a preformed curvature but configured to bend when placed under constraint;
a stylet comprising a proximal handle and a distal elongate shaft,
wherein the distal elongate shaft comprises a curved distal end portion having a preformed curvature but configured to bend when placed under constraint and a distal channeling tip,
wherein a length of the curved distal end portion of the distal elongate shaft proximal to the distal channeling tip comprises a platform having a cross-section circumference profile that is less than a full cross-section circumference profile such that there is a larger gap between an outer cross-sectional dimension of the platform of the distal elongate shaft and the inner diameter of the curved distal end portion of the cannula along the length of the curved distal end portion of the distal elongate shaft, and
wherein the proximal handle of the stylet actuates so as to cause proximal axial retraction of the stylet with respect to the cannula when the proximal handle of the stylet is engaged with the proximal handle of the cannula.
9. The system of claim 8 , wherein the cross-section circumference profile of the platform comprises a “D” shape.
10. The system of claim 8 , wherein an upper surface of the platform is generally flat.
11. The system of claim 8 , wherein a maximum vertical cross-sectional dimension of the length of the platform is between 50% and 70% of a maximum cross sectional dimension of proximal and distal regions immediately bordering the platform.
12. The system of claim 8 , wherein a ratio of vertical thickness of the platform to proximal and distal regions immediately bordering the platform is between 2:5 and 4:5.
13. The system of claim 8 , wherein the proximal handle of the stylet comprises an actuator configured to toggle between an active configuration and an inactive configuration, wherein toggling to the active configuration causes proximal axial retraction of the stylet with respect to the cannula.
14. The system of claim 13 , wherein the length of the curved distal end portion of the distal elongate shaft is configured to remain within the cannula and the distal channeling tip extends out of the open distal tip of the cannula in the inactive configuration.
15. The system of claim 1 , wherein the proximal handle of the stylet comprises an actuator configured to toggle between an active configuration and an inactive configuration, wherein toggling to the active configuration causes proximal axial retraction of the stylet with respect to the cannula.
16. The system of claim 1 , wherein the cross-section circumference profile provides improved cephalad-caudal steering because the curved distal end portion of the distal elongate shaft primarily bends inward and not laterally.
17. A system configured to provide curved access within bone, the system comprising:
a cannula comprising a proximal handle with a curved insertion slot and a distal polymeric tube,
wherein the distal polymeric tube comprises a curved distal end portion having a preformed curvature but configured to bend when placed under constraint;
a stylet comprising a proximal handle and a distal elongate shaft,
wherein the distal elongate shaft comprises a curved distal end portion having a preformed curvature but configured to bend when placed under constraint and a distal channeling tip,
wherein a length of the curved distal end portion of the distal elongate shaft proximal to the distal channeling tip comprises a cross-section circumference profile that is less than a full cross-section circumference profile such that there is a larger gap between an outer cross-sectional dimension of the curved distal end portion of the distal elongate shaft and the inner diameter of the curved distal end portion of the cannula along the length of the curved distal end portion,
wherein the cross-section circumference profile is asymmetric,
wherein a maximum vertical cross-sectional dimension of the length of the curved distal end portion of the stylet is between 40% and 80% of a maximum cross-sectional dimension of proximal and distal regions bordering the length of the curved distal end portion of the stylet, and
wherein the proximal handle of the stylet comprises an actuator configured to cause proximal axial retraction of the stylet with respect to the cannula when the proximal handle of the stylet is engaged with the proximal handle of the cannula.
18. The system of claim 17 , wherein the cross-section circumference profile comprises a “D” shape that is designed to prevent twisting during insertion of the stylet, and wherein the cross-section circumference profile provides improved cephalad-caudal steering because the curved distal end portion of the distal elongate shaft primarily bends inward and not laterally.
19. The system of claim 17 , wherein the length of the curved distal end portion of the distal elongate shaft is configured to remain within the cannula and the distal channeling tip extends out of the open distal tip of the cannula in the inactive configuration.
20. The system of claim 17 , wherein the proximal handle of the stylet comprises an upper surface that is adapted for malleting by a mallet and a lower surface that is adapted to facilitate removal of the stylet by two or more fingers of an operator, and wherein a central lumen of the cannula is coated with a lubricant.