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CN-121985914-A - Devices, kits and methods for ablating a spinal nerve via a side wall of a vertebral body

CN121985914ACN 121985914 ACN121985914 ACN 121985914ACN-121985914-A

Abstract

A trocar, kit, and method for vertebral based nerve ablation are described herein. The trocar is configured for insertion into the back of the patient in a posterior-anterior direction, at the caudal or cephalad portion of the transverse process of the patient's vertebrae, to reach the lateral surfaces of the vertebral bodies of the vertebrae. The trocar includes a curved distal tip having a length and a curvature configured to provide a desired insertion angle at a bone entry point located on a side wall of the vertebral body. The trocar is also configured to be used and packaged as a kit with devices such as a stylet, cannula, drill and probe, all of which can be introduced into the trocar interior. A method of performing an ablative treatment of a spinal nerve by accessing an interior of the vertebral body through the sidewall of the vertebral body is also described.

Inventors

  • Ji Yaomu Xiaoweite
  • Olivier Clark Lamaris
  • Daniel. Kosich

Assignees

  • 宾姆医疗有限公司

Dates

Publication Date
20260505
Application Date
20240807
Priority Date
20230807

Claims (20)

  1. 1. A trocar for use in the ablation of a spinal nerve of a patient, the trocar comprising: Handle, and A rigid hollow shaft, the shaft comprising: Proximal, straight elongate section, curved distal section and distal tip, A lumen extending within the shaft from the proximal end to the distal tip, Wherein the lumen of the shaft is adapted to receive and guide at least one of a bone penetrating device and a bone slotting device from the proximal end of the shaft toward the distal tip thereof, and Wherein the trocar is configured for insertion into the back of the patient in a posterior-to-anterior direction, at the caudal or cephalad portion of the transverse process of the patient's vertebrae, to reach the lateral surfaces of the vertebral bodies of the vertebrae, The introducing further entails positioning the distal tip of the hollow shaft at a bone entry point on the sidewall surface of the vertebral body, the bone entry point being defined by a linear projection between a spinal nerve ablation site toward the sidewall surface of the vertebral body, wherein the linear projection is substantially tangential to the curved distal portion of the shaft, and Wherein the curved distal portion of the shaft comprises a length and a curvature configured to (i) provide a desired insertion angle at the bone entry point, and (ii) direct the at least one of a bone penetrating device and a bone slotting device toward the spinal nerve ablation site substantially along the tangential linear projection.
  2. 2. A trocar for vertebral-based nerve ablation, comprising: Handle, and A rigid hollow shaft, the shaft comprising: Proximal, straight elongate section, curved distal section and distal tip, A lumen extending within the shaft from the proximal end to the distal tip, Wherein the lumen of the shaft is adapted to receive and guide at least one of a bone penetrating device and a bone slotting device from the proximal end of the shaft towards the distal tip thereof, and Wherein the trocar is configured for insertion into the back of the patient in a posterior-to-anterior direction, at the caudal or cephalad portion of the transverse process of the patient's vertebrae, to reach the lateral surfaces of the vertebral bodies of the vertebrae, The introducing further entails positioning the distal tip of the hollow shaft at a bone entry point on the sidewall surface of the vertebral body, the bone entry point being defined by a curved projection of a spinal nerve ablation site toward between the sidewall surface of the vertebral body, and Wherein the curved distal portion of the shaft comprises a length and a curvature configured to (i) provide a desired insertion angle at the bone entry point, and (ii) provide the curved projection to direct the at least one of a bone penetrating device and a bone slotting device substantially along the curved projection toward the spinal nerve ablation site.
  3. 3. The trocar of claim 1 or 2, wherein the curved distal portion has a radius of curvature of about 10mm to about 50mm and an angle of curvature of about 30 ° to about 120 °.
  4. 4. A trocar as claimed in any one of claims 1 to 3, wherein the curved distal portion has a radius of curvature of about 35mm and an angle of curvature of about 75 °.
  5. 5. The trocar of any one of claims 1 to 4, wherein the lumen of the shaft has a diameter of about 1mm to about 5mm.
  6. 6. The trocar of any one of claims 1 to 5, wherein the rigid hollow shaft is made of a material selected from the group consisting of medical grade metal or medical grade plastic.
  7. 7. The trocar of claim 6, wherein the medical grade metal is stainless steel, titanium, or nickel titanium alloy, and wherein the medical grade plastic is Polyetheretherketone (PEEK) or polyetherimide.
  8. 8. The trocar of any one of claims 1 to 7, wherein the handle is coupled to the proximal end of the trocar, the handle and the rigid hollow shaft defining a T-shape, and a grip is provided to manipulate the trocar by a user.
  9. 9. The trocar of claim 8, wherein the handle comprises: a rigid strip coupled to the proximal end of the trocar and substantially perpendicular to the straight elongated portion of the trocar, the strip comprising: A side extension defining the T-shape with the straight elongated portion of the shaft of the trocar, the side extension configured to provide a pulling grip for a user's finger, and A central opening in fluid communication with the lumen of the trocar.
  10. 10. The trocar of claim 9, wherein the handle further comprises a fluid access port in fluid communication with the lumen of the rigid hollow shaft to inject fluid into the trocar interior.
  11. 11. The trocar of claim 10, wherein the fluid access port comprises a locking connector.
  12. 12. A kit for use in vertebral-based nerve ablation, the kit comprising: a trocar, and at least one of a bone penetrating device and a bone slotting device; The trocar includes: Handle, and A rigid hollow shaft, the shaft comprising: Proximal, straight elongate section, curved distal section and distal tip, A lumen extending within the shaft from the proximal end to the distal tip, Wherein the lumen of the shaft is adapted to receive and guide the bone penetrating device and the bone slotting device from its proximal end towards its distal tip, The bone penetrating device includes: an elongate rod extending from a proximal end to a sharp distal tip, Wherein the elongated rod The diameter is sized to slide within the lumen of the trocar, Is deformable to move along the curved distal portion of the trocar, Longer than the trocar such that when inserted therein, the sharp distal tip of the elongate rod protrudes beyond the distal tip of the hollow shaft, and Wherein the sharp distal tip is sufficiently rigid to pierce a side wall of a vertebral body of a patient, The bone slotting device comprises: an elongate shaft extending from a proximal end to a distal tip, Wherein the elongated rod The diameter is sized to slide within the lumen of the trocar, Is deformable to move along the curved distal portion of the trocar, Longer than the hollow shaft of the trocar, such that when inserted therein, the distal tip of the elongate shaft extends beyond the distal tip of the trocar, Wherein the bone slotting device optionally includes nerve ablation capability, and Wherein the sharp distal tip of the bone slot is sufficiently rigid to pierce the side wall of the vertebral body of a patient.
  13. 13. The kit of claim 12, wherein the kit comprises both a bone penetrating device and a bone slotting device.
  14. 14. The kit of claim 12, wherein the kit comprises two bone penetrating devices and/or two slotting devices.
  15. 15. The kit of any one of claims 12 to 14, wherein: The trocar is configured for introduction into a back of a patient and is configured for precise positioning of a distal tip thereof at a bone entry point located on a side wall of a vertebral body of the patient, the bone entry point being defined by a linear projection between a spinal nerve ablation site toward the side wall surface of the vertebral body, wherein the linear projection is substantially tangential to the curved distal portion of the shaft, and Wherein the curved distal portion of the shaft comprises a length and a curvature configured to (i) provide a desired angle of insertion at the bone entry point, and (ii) direct the sharp distal tip of the bone penetrating device and/or the distal tip of the bone slotting device toward the vertebral nerve ablation site substantially along the tangential linear projection.
  16. 16. The kit of any one of claims 12 to 15, wherein the bone penetrating device and/or the bone grooving device comprises a curved distal tip.
  17. 17. The kit of claim 16, wherein the kit further comprises, The bone entry point is defined by a curved projection of a vertebral-based nerve ablation site toward the sidewall surface of the vertebral body, and Wherein the curved distal portion of the shaft of the trocar includes a length and a curvature configured to (i) provide a desired insertion angle at the entry point, and (ii) direct the curved distal tip of the bone penetrating device and/or the curved distal tip of the bone grooving device substantially along the curved projection toward the vertebral nerve ablation site.
  18. 18. The kit of any one of claims 12 to 17, wherein the bone penetrating device comprises: an elongate rod extending from a proximal end to a sharp distal tip, Wherein the elongated rod The diameter is sized to slide within the lumen of the trocar, Is deformable to move along the curved distal portion of the trocar, Longer than the trocar such that when inserted therein, the sharp distal tip of the elongate rod protrudes beyond the distal tip of the hollow shaft, and Wherein the sharp distal tip is sufficiently rigid to pierce the side wall of the vertebral body of a patient.
  19. 19. The kit of claim 18, wherein the elongate rod of the bone penetrating device further comprises a lumen sized to receive and guide the bone slotting device.
  20. 20. The kit of claim 18, wherein the sharp distal tip of the elongate rod is curved to enter the spinal nerve in a curved trajectory inside the vertebral body.

Description

Devices, kits and methods for ablating a spinal nerve via a side wall of a vertebral body Cross Reference to Related Applications The present patent application claims priority from application Ser. No. US63/517,960, filed 8/7 at 2023, the contents of which are incorporated herein in their entirety. Technical Field The present invention relates to the field of spinal surgery, and more particularly to surgery requiring access to the interior of a patient's vertebrae, such as vertebral based nerve ablation. Background Vertebral-derived pain is a specific type of lower back pain caused by vertebral endplate injury. Spinal nerve (basivertebral nerve, BVN) ablation is a spinal surgery procedure by which BVN is ablated when the spinal nerve is the source of chronic back pain, as is often the case with vertebral-derived pain. There are different methods and medical devices currently available for performing various types of spinal surgery, such as those described in patent EP2386260, patent US8192435, patent US10524819 and patent applications US2012/0221007 and US 2021/023691. However, these devices are not configured for use in surgical procedures within vertebrae, let alone BVN ablation. While the goal of existing procedures is generally as minimally invasive as possible, there is room for improvement. In fact, one challenge in maintaining such minimally invasive surgery is the posterior and central location of the BVN within the vertebral body, which is very close to the spinal canal. The BVN trunk is located in the posterior third of the vertebral body, about 1cm from the ventral side of the posterior wall of the vertebral body, and thus a bending system is typically required to safely reach the target site. Current procedures use a trocar of approximately 4.2mm diameter that passes through the pedicle of the vertebra. Pedicles are narrow hard bone funnels. The limited width of the pedicles limits the ability of the trocar to orient inside the vertebral body. The axis of the trocar cannot coincide with the spinal nerve trunk as the target site for the ablation probe because the BVN trunk is too close to the posterior wall of the vertebral body. Once the trocar has reached the posterior wall of the vertebral body, a pre-curved cannula (and its curved or straight stylet), typically made of plastic, of about 3mm diameter, is pushed into the lumen of the trocar and forced into the cancellous bone to form a tightly curved channel of radius of curvature of about 10mm to reach the BVN trunk. Endplate inflammation associated with vertebral body conditions affecting vertebral-derived pain patients may cause bone densification, also known as bone sclerosis. This can lead to difficulties in manipulating the instrument in cancellous bone. The presence of bone sclerosis generally results in a reduction in the expected curvature of the cancellous bone of the vertebral body, resulting in a significant difference between the target ablation site and the actual ablation site. If the probe is not in the correct position to reach the BVN trunk, a larger lesion volume is required, which results in weakening of the vertebral body and potential vertebral compression fracture. After BVN ablation using current devices, the FDA "manufacturer and user facility device experience" reported multiple fractures. A common complication associated with this procedure is the interaction between the curved instrument and the straight trocar. When instruments are removed from the trocar, their shafts tend to contact and often catch on the sharp edges of the trocar. Considering that the cannula and probe shaft are made of plastic, i.e., a material that is generally less durable than the stainless steel of the trocar, they may catch on the sharp edges of the trocar as they interact with the trocar. This results in a gap in the plastic material. This notch may result in repeated card sticks each time the instrument is subsequently inserted and withdrawn. At the end of the procedure, when the instrument is withdrawn, the catch may cause a section from the bending instrument to be severed, which may then inadvertently remain in the patient. This situation is contrary to the design of the instrument, which is not intended to deposit debris in the patient, considering that it is not an implantable device. After BVN ablation using current devices, the FDA "manufacturer and user facility device experience" also reports a number of events involving instrument debris remaining in the patient. Another challenge with existing devices is to maintain the pre-curved cannula as it is inserted into the straight lumen of the trocar. This requires a flexible material or design that is in contrast to the need for the cannula to maintain its rigidity and shape to create a curved channel in the bone. Furthermore, in the case of spinal fusion where the patient has previously received pedicle implant screws, the accessibility of the trocar to the pedicle is compromised.