Accessing and treating tissue within a vertebral body

Patent metadata

Field	Value
Publication number	US-2021267632-A1
Application number	US-202117302949-A
Country	US
Kind code	A1
Filing date	May 17, 2021
Priority date	Sep 12, 2019
Publication date	Sep 2, 2021
Grant date	—

Abstract

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.

First claim

What is claimed is:

1 . A method of accessing and treating tissue at a target location within a vertebral body, the method comprising:
inserting a distal portion of an introducer assembly through a pedicle adjacent the vertebral body to a cancellous bone region of the vertebral body; inserting a distal portion of a curved cannula assembly through a lumen of the introducer assembly and out of the open distal tip of the introducer assembly to form a curved path within the cancellous bone region of the vertebral body, wherein the curved cannula assembly comprises:
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 and an open distal tip;
a stylet comprising a proximal handle and a distal elongate shaft,
wherein the distal elongate shaft comprises a curved distal end portion 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 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,
wherein the cross-section circumference profile of the length of the curved distal end portion of the distal elongate shaft comprises a “D” shape,
removing the stylet from the cannula;
inserting a distal end portion of a radiofrequency probe through the cannula and to the target location; and
ablating a nerve at the target location with the radiofrequency probe.

2 . The method of claim 1 , wherein:
an upper surface of the length of the curved distal end portion is generally flat, the cross-section circumference profile causes the curved distal end portion of the distal elongate shaft to primarily bend inward, 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 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 method of claim 1 , further comprising toggling an actuator 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.

4 . The method of claim 1 , further comprising keeping the length of the curved distal end portion of the distal elongate shaft of the stylet within the cannula during the step of inserting the distal portion of the curved cannula assembly.

5 . The method of claim 1 , wherein the introducer assembly comprises an introducer cannula and an introducer stylet inserted within the introducer cannula.

6 . The method of claim 5 , further comprising removing the introducer stylet from the introducer cannula prior to inserting the distal portion of the curved cannula assembly.

7 . The method of claim 1 , further comprising inserting an introducer drill into and through an introducer cannula of the introducer assembly after initial penetration into the pedicle by the introducer assembly in order to complete traversal of the pedicle and penetration through a cortical bone region of the vertebral body until the cancellous bone region is reached.

8 . A method of accessing and treating tissue at a target location within a vertebral body, the method comprising:
inserting a distal portion of a curved cannula assembly within a cancellous bone region of the vertebral body to form a curved path, wherein the curved cannula assembly comprises:
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 and an open distal tip;
a stylet comprising a proximal handle and a distal elongate shaft,
wherein the distal elongate shaft comprises a curved distal end portion 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,
wherein the cross-section circumference profile of the platform of the distal elongate shaft comprises a “D” shape,
removing the stylet from the cannula;
inserting a distal end portion of a treatment device through the cannula and to the target location; and
performing a treatment procedure at the target location with the treatment device.

9 . The method of claim 8 , further comprising toggling an actuator 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.

10 . The method of claim 8 , further comprising keeping the length of the curved distal end portion of the distal elongate shaft of the stylet within the cannula during the step of inserting the distal portion of the curved cannula assembly.

11 . The method of claim 8 , wherein performing the treatment procedure comprises ablating a basivertebral nerve.

12 . The method of claim 8 , wherein performing the treatment procedure comprises ablating a tumor.

13 . The method of claim 8 , wherein the treatment device is a radiofrequency probe.

14 . The method of claim 8 , wherein:
an upper surface of the platform is generally flat, 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, and a ratio of vertical thickness of the platform to proximal and distal regions immediately bordering the platform is between 2:5 and 4:5.

15 . A method of accessing and treating tissue at a target location within a vertebral body, the method comprising:
inserting a distal portion of a curved cannula assembly within a cancellous bone region of the vertebral body to form a curved path, wherein the curved cannula assembly comprises:
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 and an open distal tip;
a stylet comprising a proximal handle and a distal elongate shaft,
wherein the distal elongate shaft comprises a curved distal end portion 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 p

Assignees

• Relievant Medsystems Inc

Inventors

• Donovan Brian W
• Pruitt Alexander
• Willink Michael

Classifications

• A61B2018/126

  bipolar · CPC title

• A61B2018/00994

  combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound · CPC title

• A61B2018/00732

  Frequency · CPC title

• A61B2018/00714

  Temperature · CPC title

• A61B2018/00577

  Ablation · CPC title