US 12303166

US Patent 12303166, titled "Methods for accessing nerves within bone," was filed on July 19, 2024, and issued on May 20, 2025. The patent is assigned to Relievant Medsystems Inc., with inventors Richard Pellegrino, Samit Patel, and Harold Carrison.

The abstract describes methods for ablating a basivertebral nerve (BVN) in a patient's lumbar or sacral vertebral body. This involves selecting an introducer and other instruments based on a pre-surgical evaluation, inserting the introducer through a pedicle of the vertebral body to reach the cancellous bone, and then delivering instruments through the introducer's central channel. A deflectable section of the instruments is advanced to a position near the BVN in the posterior midline section of the vertebral body. Finally, an active element is extended, and energy is delivered to it to ablate a portion of the BVN.

The provided patent text outlines several "inventive embodiments" that function as summaries of the patent's core claims. It's important to note that the provided text does not contain a formal "CLAIMS" section with all numbered claims, thus a complete overview of every independent claim cannot be provided with certainty. However, based on the presented "inventive embodiments," the key independent concepts include:

• System for Channeling a Path into Bone (Embodiment 1): This system comprises a trocar with a central channel and a distal opening, and a curved cannula designed to fit within the trocar. The cannula has a deflectable tip with a preformed curve that straightens when inside the trocar but regains its curve upon exiting, thereby creating a curved path in the bone. The cannula also has a central passageway for delivering a treatment device beyond this curved path.
• Method for Channeling a Path into Bone (Embodiment 10): This method involves inserting a trocar into a bone region near a treatment location. A cannula with a deflectable, preformed curved tip is delivered through the trocar. The tip straightens while in the trocar and curves upon exiting, creating a curved path in the bone. A treatment device is then delivered through the cannula to a location beyond this curved path.
• Kit for Channeling a Path into Bone (Another Aspect): This kit includes a trocar and a selection of cannulas. Each cannula has a deflectable distal tip with a preformed curve that straightens when delivered through the trocar and regains its curve upon exiting, creating a curved path. The cannulas have central passageways for treatment devices, and the set offers cannulas with varying preformed curvatures at their distal tips.

As of the patent's fetch date (June 18, 2026), there is ongoing litigation involving US Patent No. 12,303,166. The U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed a district court's denial of a preliminary injunction sought by Boston Scientific Corp. and Relievant Medsystems, Inc. against Stryker Corporation. This injunction aimed to prevent the launch of Stryker's OptaBlate BVN spinal ablation device. The dispute specifically concerns whether Stryker's product induced infringement of claims 16 and 21 of the '166 patent. The patent generally covers methods for using a radiofrequency probe to ablate the basivertebral nerve, which is involved in transmitting pain signals from damaged vertebral endplates.

The US Patent 12303166 is currently involved in litigation.

Here are the details of the known litigation:

• Plaintiff(s): Boston Scientific Corporation and Relievant Medsystems, Inc.

• Defendant(s): Stryker Corporation

• Jurisdiction: U.S. District Court for the District of New Jersey (initial denial of preliminary injunction), and U.S. Court of Appeals for the Federal Circuit (CAFC) (affirmation of denial)

• Case Number:

  • District Court: 25-cv-12700 (New Jersey District Court)
  • CAFC: 26-1171 (Court of Appeals for the Federal Circuit)

• Filing Date: July 2, 2025 (District Court)

• Outcome/Current Status: The U.S. District Court for the District of New Jersey denied a preliminary injunction sought by Boston Scientific Corp. and Relievant Medsystems, Inc. to prevent Stryker Corporation's launch of its OptaBlate BVN spinal ablation device. This denial was affirmed by the U.S. Court of Appeals for the Federal Circuit (CAFC) in a decision issued on June 17, 2026. Boston Scientific had argued that Stryker would induce physicians to infringe claims 16 and 21 of the '166 patent. The CAFC concluded that Boston Scientific had not demonstrated a likelihood of success on the merits.Known litigation involving US patent 12303166 includes the following case:

• Plaintiff(s): Boston Scientific Corporation and Relievant Medsystems, Inc.

• Defendant(s): Stryker Corporation

• Jurisdiction:

  • U.S. District Court for the District of New Jersey
  • U.S. Court of Appeals for the Federal Circuit (CAFC)

• Case Number:

  • District Court: 2:25-cv-12700
  • CAFC: 26-1171

• Filing Date: July 2, 2025 (District Court)

• Outcome or Current Status: The U.S. District Court for the District of New Jersey denied a preliminary injunction sought by Boston Scientific Corp. and Relievant Medsystems, Inc. against Stryker Corporation's OptaBlate BVN spinal ablation device. This denial was affirmed by the U.S. Court of Appeals for the Federal Circuit (CAFC) in a decision issued on June 17, 2026. Boston Scientific argued that Stryker's product induced infringement of claims 16 and 21 of the U.S. Patent No. 12,303,166. The CAFC found that Boston Scientific had not demonstrated a likelihood of success on the merits, particularly regarding the doctrine of equivalents infringement.

Proceedings overview

There is no PTAB activity on file for US Patent 12303166.

Strategic summary

As there are no PTAB proceedings on file for US Patent 12303166, all claims of the patent remain untested at the PTAB. This means there is no estoppel landscape established by AIA trials.

Recommended next steps

There is no PTAB activity on file for US Patent 12303166. The absence of PTAB activity is noteworthy, as well-asserted patents often become targets for IPRs. If facing an assertion of this patent, exploring an IPR or other AIA trial proceeding could be a viable defensive strategy, as the claims have not yet been challenged before the PTAB.

Inventors

• Richard Pellegrino
• Samit Patel
• Harold Carrison

At the time of filing, all inventors were associated with Relievant Medsystems Inc., the original assignee.

Original assignee

The original assignee, Relievant Medsystems Inc., is an operating company in the medical device sector. They develop and market devices for minimally invasive treatments, particularly in the spinal space, including procedures related to the basivertebral nerve (BVN). Their product line, which includes the Intracept® System, embodies the claims described in US12303166, as it is used for basivertebral nerve ablation. Relievant Medsystems Inc. is currently operating and was acquired by Boston Scientific Corporation in January 2023.

Assignment timeline

There are no assignment records for US12303166 on the USPTO Assignment Center. The Google Patents "Legal Events" section shows an assignment to RELIEVANT MEDSYSTEMS, INC. on 2024-11-11, with Assignors: PATEL, SAMIT, PELLEGRINO, RICHARD, CARRISON, HAROLD. This appears to be an assignment from the inventors to the original assignee, which is typically recorded shortly after filing or issuance. Since the patent was filed on 2024-07-19 and granted on 2025-05-20, this recording date of 2024-11-11 is consistent with an assignment from inventors to the initial assignee. This entry does not provide a reel/frame number as it's from Google Patents' aggregated data.

Timeline diagram

timeline
    title Ownership of US 12303166
    2024 : Application filed by Relievant Medsystems Inc
         : Assigned to Relievant Medsystems Inc by inventors
    2025 : Patent granted
    2026 : Litigation filed by Boston Scientific/Relievant

NPE / troll-pattern signals

1. Shell-entity transfer — not present. The patent is currently held by Relievant Medsystems Inc., an operating company.
2. Known asserter in the chain — not present. Relievant Medsystems Inc. and Boston Scientific Corporation are operating companies.
3. Repeat correspondent across the chain — unclear. Without USPTO Assignment Center records, correspondent information beyond the initial Google Patents entry (which only lists the inventors as assignors) is not available.
4. Cascading transfers — not present. There are no recorded transfers.
5. Pre-litigation transfer — not present. The patent was assigned to Relievant Medsystems Inc. in November 2024, and litigation began in July 2025, which is outside the 6-month window for this signal.
6. Bankruptcy fire-sale — not present. Relievant Medsystems Inc. was acquired by Boston Scientific, not subject to bankruptcy.
7. Privateering — unclear. While Boston Scientific acquired Relievant, the current litigation involves Boston Scientific and Relievant as plaintiffs against Stryker, indicating a direct assertion by operating companies against a competitor. There is no explicit evidence of privateering.
8. Defensive aggregator (anti-NPE) — not present. The current owners are actively asserting the patent.

Verdict

Operating-company assertion

The patent is currently owned by Relievant Medsystems Inc., which is an operating company acquired by Boston Scientific Corporation. Both companies develop and market medical devices and are actively asserting the patent against a direct competitor, Stryker Corporation, as indicated by the ongoing litigation (District Court Case 2:25-cv-12700 and CAFC Case 26-1171). This aligns with an operating-company assertion model rather than an NPE model.

US Patent Assignment Search: https://assignmentcenter.uspto.gov/

Most Relevant Prior Art for US Patent 12303166

US Patent 12303166 cites several prior art documents. The most relevant patent prior art, identified from the "Cited by applicant" section on Google Patents for US12303166, along with a scientific paper mentioned in the patent's "Description of Related Art," are analyzed below. It is important to note that a formal "CLAIMS" section for US12303166 was not provided, so the assessment of potential anticipation refers to the "inventive embodiments" outlined in the patent summary.

Scientific Publication (Non-Patent Prior Art)

• Full Citation: Kopecky, K. K., Broderick, L. S., Davidson, D. D., & Burney, B. T. (1996). Side-exiting coaxial needle for aspiration biopsy. AJR. American Journal of Roentgenology, 167(3), 661–662.
• Publication Date: September 1996
• Brief Description: This paper describes a side-exiting coaxial needle system for aspiration biopsy. A smaller needle is advanced through a guide needle and exits through a side hole. The guide needle can then be rotated to allow sampling of different regions of a mass without repositioning the guide needle.
• Potential Anticipation (under 35 U.S.C. § 102): This publication introduces the concept of a side-exiting needle system for accessing multiple tissue sites from a single entry point, which is a foundational concept for creating non-linear paths. US12303166 acknowledges this prior art but distinguishes itself by stating that Kopecky's device does not guarantee a linear exit path or predictable navigation in varying tissue densities, which is a key problem US12303166 aims to solve with its preformed curved cannulas and stylets. While it describes a mechanism for deflecting a needle, it does not detail the creation of a curved path in bone with predictable curvature or the subsequent creation of a straight channel after the curve for a treatment device, as claimed by US12303166's inventive embodiments.

Patent Prior Art (Cited by Applicant)

1. US6699242B1

• Full Citation: US6699242B1, Tissue ablation system and methods, issued to Michael L. Treat on March 4, 2003.
• Publication/Filing Date: Issued March 4, 2003. (Filing date not available in immediate search results, but older than 2008 priority of US12303166).
• Brief Description: This patent generally describes systems and methods for tissue ablation, often using radiofrequency energy. It focuses on various aspects of tissue ablation, including probes and techniques for delivering energy to target tissues.
• Potential Anticipation (under 35 U.S.C. § 102): US12303166 references US6699242B1 for its description of ablating tissue of a target region, specifically the BVN. While US6699242B1 covers the ablation method itself, it does not appear to teach or suggest the systems and methods for generating a predictable curved path in bone to access the target tissue, which is the primary focus of US12303166's inventive embodiments (specifically Embodiments 1 and 10, relating to the trocar, curved cannula, and stylet system for channeling a path in bone, and the method of using it). Therefore, it anticipates the treatment modality aspect (e.g., thermal ablation as described in some specific embodiments of US12303166 where the treatment device comprises an RF probe), but not the novel access tools or methods for creating curved paths in bone.

2. US20080275460A1

• Full Citation: US20080275460A1, System and method for creating a steered path in bone, by Richard Pellegrino, Samit Patel, and Harold Carrison, published November 6, 2008.
• Publication/Filing Date: Published November 6, 2008. (This is a publication of an application, meaning its filing date precedes this publication date and also the priority date of US12303166, which is September 26, 2008, meaning it's highly relevant prior art if its filing date is before Sep 26, 2008).
• Brief Description: This publication describes systems and methods for creating a steered path in bone using an introducer and a steerable stylet or cannula. It aims to create a precise path in bone, for example, to access basivertebral nerves in the spine.
• Potential Anticipation (under 35 U.S.C. § 102): Given the shared inventors and the title, this patent application is highly relevant. It appears to be a direct predecessor or related work. It describes a "steered path in bone," which directly aligns with the core inventive concept of US12303166 (generating a curved path in bone). This publication likely anticipates aspects of US12303166's Embodiments 1 and 10, particularly the general concept of a system and method for creating a non-linear path in bone using steerable instruments. Without the full text of US20080275460A1, it's difficult to pinpoint exact claim overlap, but the title and abstract suggest strong potential for anticipation of the broad concepts of creating a curved bone path for nerve access.

3. US20090099566A1

• Full Citation: US20090099566A1, Radiofrequency nerve ablation probe and method, by Richard Pellegrino, Samit Patel, and Harold Carrison, published April 16, 2009.
• Publication/Filing Date: Published April 16, 2009.
• Brief Description: This publication focuses on a radiofrequency (RF) probe and methods specifically for nerve ablation. It likely describes the design and use of an RF probe, potentially including features for targeted energy delivery to nerves.
• Potential Anticipation (under 35 U.S.C. § 102): This publication, also by the same inventors, likely anticipates the treatment device aspects of US12303166, particularly the use of an RF bipolar probe (as mentioned in US12303166's summary and detailed description). It may anticipate the part of Embodiment 10 that involves "delivering a treatment device... to the treatment location beyond the curved path" and the preferred embodiment where "a portion of the BVN is denervated by delivering focused, therapeutic heating." However, it is unlikely to anticipate the novel systems and methods for creating a curved path in bone (Embodiments 1 and 10's core inventive features).

4. WO2008039234A2

• Full Citation: WO2008039234A2, System and method for creating a steered path in bone, by Richard Pellegrino, Samit Patel, and Harold Carrison, published April 3, 2008.
• Publication/Filing Date: Published April 3, 2008.
• Brief Description: This international publication describes a system and method for creating a steered path in bone, particularly for accessing nerves within the spine. It discusses using an introducer and a steerable instrument (e.g., a stylet or cannula) to navigate bone.
• Potential Anticipation (under 35 U.S.C. § 102): Similar to US20080275460A1, this international application (also by the same inventors) directly addresses the core concept of creating a "steered path in bone." Its publication date is prior to the priority date of US12303166 (September 26, 2008), making it highly relevant prior art. It very likely anticipates the fundamental idea of using specialized instruments to generate a curved path in bone, and therefore could potentially anticipate aspects of US12303166's Embodiments 1 and 10 that describe such a system and method. The specific details of how predictability is achieved (e.g., the tube-within-tube embodiment, the material properties, the angled tips for maintaining curvature) in US12303166 would need to be compared against the full disclosure of WO2008039234A2 for a more definitive assessment.

5. US20080183204A1

• Full Citation: US20080183204A1, Radiofrequency ablation catheter with fluid cooled active electrode, by Daniel J. Davenport and Jack H. Lin, published August 7, 2008.
• Publication/Filing Date: Published August 7, 2008.
• Brief Description: This publication describes a radiofrequency ablation catheter, specifically featuring a fluid-cooled active electrode. The focus is on controlling temperature during RF ablation, often to create larger lesions or prevent charring.
• Potential Anticipation (under 35 U.S.C. § 102): This prior art relates to the treatment device itself and its functionality, particularly aspects of RF ablation. It could potentially anticipate some details of the "active element" (102) and "treatment probe" (100) described in US12303166, especially if US12303166's probe incorporates fluid cooling. However, it does not address the primary inventive concepts of US12303166, which are the systems and methods for accessing the nerve within bone via a predictable curved path (Embodiments 1, 10, and the kit aspect).

6. US20090259220A1

• Full Citation: US20090259220A1, Intraosseous nerve ablation systems and methods, by Richard Pellegrino, Samit Patel, and Harold Carrison, published October 15, 2009.
• Publication/Filing Date: Published October 15, 2009.
• Brief Description: This publication details systems and methods for ablating intraosseous nerves, specifically mentioning basivertebral nerves (BVN). It encompasses the overall procedure for treating such nerves.
• Potential Anticipation (under 35 U.S.C. § 102): This publication, again by the same inventors, shares a very similar inventive goal with US12303166: "intraosseous nerve ablation systems and methods." Given its publication date is after the priority date of US12303166 (Sep 26, 2008), it is likely not 102 prior art unless its filing date is earlier than Sep 26, 2008. However, if its filing date is earlier, then it could potentially anticipate the overall method of therapeutically treating a vertebral body by inserting an energy device and depositing energy to denervate the BVN, as described in one aspect of US12303166's summary. It may also provide more specific details about the treatment location (e.g., between the BVN junction and outer cortical bone) which is also described in US12303166.

7. US20100087823A1

• Full Citation: US20100087823A1, Steerable stylet assembly, by Richard Pellegrino, Samit Patel, and Harold Carrison, published April 8, 2010.
• Publication/Filing Date: Published April 8, 2010.
• Brief Description: This publication describes a steerable stylet assembly, likely for use within a cannula or introducer to navigate through tissue, potentially including bone, by providing a steerable tip.
• Potential Anticipation (under 35 U.S.C. § 102): Similar to the previous applications by the same inventors, this publication's later publication date (April 8, 2010) suggests it is not 102 prior art to US12303166 unless its filing date precedes September 26, 2008. If it does, then the concept of a "steerable stylet assembly" could potentially anticipate the "curved stylet" (60) and the "straightening stylet" (40) of US12303166, which are used to define and reinforce the curved path. It would be relevant to the components and their steerable nature in Embodiment 1, and the steps involving these stylets in Embodiment 10.

Note on Anticipation: A thorough anticipation analysis under 35 U.S.C. § 102 requires a detailed comparison of each element of US12303166's claims (or inventive embodiments, in this case) against the full disclosure of each prior art document. The above assessment is based on available abstracts and general descriptions.### Most Relevant Prior Art for US Patent 12303166

US Patent 12303166, "Methods for accessing nerves within bone," lists several prior art documents. The following analysis details the most relevant prior art, drawn from the "Cited by applicant" section on Google Patents for US12303166 and a scientific publication mentioned within the patent's "Description of Related Art." It is important to note that a formal "CLAIMS" section for US12303166 was not provided in the prompt; therefore, the assessment of potential anticipation refers to the "inventive embodiments" as proxies for claims.

Scientific Publication (Non-Patent Prior Art)

• Full Citation: Kopecky, K. K., Broderick, L. S., Davidson, D. D., & Burney, B. T. (1996). Side-exiting coaxial needle for aspiration biopsy. AJR. American Journal of Roentgenology, 167(3), 661–662.
• Publication Date: September 1996
• Brief Description: This paper describes a coaxial needle system designed for aspiration biopsy, featuring a guide needle with a side hole. A smaller inner needle is advanced and deflected out through this side hole. The guide needle can then be rotated to enable sampling from different areas of a mass without requiring full repositioning of the guide needle.
• Potential Anticipation (under 35 U.S.C. § 102): US12303166 acknowledges this prior art, noting that while it introduces the concept of a side-exiting needle for accessing multiple tissue sites, it does not guarantee a linear exit path or predictable navigation through tissues of varying densities. The Kopecky paper anticipates the general idea of deflecting a needle from a guide, but it does not teach the specific systems and methods of US12303166 for generating a predictable curved path within bone or creating a subsequent straight channel for a treatment device, which are central to US12303166's inventive embodiments.

Patent Prior Art (Cited by Applicant)

1. US6699242B1

• Full Citation: US6699242B1, Tissue ablation system and methods, issued to Michael L. Treat on March 4, 2003.
• Publication/Filing Date: Issued March 4, 2003.
• Brief Description: This patent describes various systems and methods for ablating tissue, often utilizing radiofrequency (RF) energy, including probes and techniques for delivering therapeutic energy to target anatomical regions.
• Potential Anticipation (under 35 U.S.C. § 102): US12303166 explicitly references US6699242B1 for its description of tissue ablation. While US6699242B1 may anticipate aspects of the treatment modality (e.g., thermal ablation using an RF probe) detailed in some specific embodiments of US12303166, it does not appear to teach or suggest the novel systems and methods for accessing nerves within bone by creating a predictable curved path, which are the primary focus of US12303166's inventive embodiments (specifically Embodiments 1 and 10 related to the trocar, curved cannula, and stylet system for channeling bone, and the corresponding method).

2. US20080275460A1

• Full Citation: US20080275460A1, System and method for creating a steered path in bone, by Richard Pellegrino, Samit Patel, and Harold Carrison, published November 6, 2008.
• Publication/Filing Date: Published November 6, 2008.
• Brief Description: This publication discloses systems and methods designed to create a steered path within bone. The objective is to establish a precise bone path, for instance, to facilitate access to basivertebral nerves in spinal procedures.
• Potential Anticipation (under 35 U.S.C. § 102): Given the shared inventors and the title, this patent application is highly relevant prior art, as its publication date (November 6, 2008) is later than the priority date of US12303166 (September 26, 2008), but its filing date likely precedes it. This publication explicitly addresses the core inventive concept of US12303166 – generating a curved or "steered" path in bone. As such, it potentially anticipates broad aspects of US12303166's Embodiments 1 (system for channeling a path into bone) and 10 (method for channeling a path into bone), particularly concerning the general idea of using steerable instruments to create non-linear bone paths for nerve access. A direct, element-by-element comparison with the full text of US20080275460A1 would be needed for a definitive anticipation analysis.

3. US20090099566A1

• Full Citation: US20090099566A1, Radiofrequency nerve ablation probe and method, by Richard Pellegrino, Samit Patel, and Harold Carrison, published April 16, 2009.
• Publication/Filing Date: Published April 16, 2009.
• Brief Description: This publication focuses on a radiofrequency (RF) probe and associated methods specifically for nerve ablation, likely describing the design and application of such probes for targeted energy delivery to nerves.
• Potential Anticipation (under 35 U.S.C. § 102): Also sharing inventors with US12303166, this publication's later publication date (April 16, 2009) suggests it is not prior art under 35 U.S.C. § 102 unless its effective filing date precedes September 26, 2008. If it does, it could anticipate the treatment device aspects of US12303166, specifically the use of an RF bipolar probe and the method steps involving "delivering a treatment device" to denervate the BVN through "focused, therapeutic heating." However, it is unlikely to anticipate the specific systems and methods for creating a predictable curved path in bone that facilitate access to the nerve, which are distinguishing features of US12303166's core inventive embodiments.

4. WO2008039234A2

• Full Citation: WO2008039234A2, System and method for creating a steered path in bone, by Richard Pellegrino, Samit Patel, and Harold Carrison, published April 3, 2008.
• Publication/Filing Date: Published April 3, 2008.
• Brief Description: This international publication describes a system and a method for creating a steered path within bone, particularly to access nerves located in the spine. It details the use of an introducer in conjunction with a steerable instrument, such as a stylet or cannula, for navigating through bone.
• Potential Anticipation (under 35 U.S.C. § 102): This international application, with a publication date (April 3, 2008) preceding the priority date of US12303166 (September 26, 2008), is highly significant prior art. It directly aligns with US12303166's core inventive concept of creating a "steered path in bone." Consequently, it very likely anticipates the fundamental ideas presented in US12303166's Embodiments 1 (system for channeling a path into bone) and 10 (method for channeling a path into bone). A detailed comparison of the specific mechanisms for achieving predictable curvature, such as the tube-within-tube design, material properties, and specialized tips described in US12303166, against the full disclosure of WO2008039234A2 would be crucial for a precise assessment of anticipation.

5. US20080183204A1

• Full Citation: US20080183204A1, Radiofrequency ablation catheter with fluid cooled active electrode, by Daniel J. Davenport and Jack H. Lin, published August 7, 2008.
• Publication/Filing Date: Published August 7, 2008.
• Brief Description: This publication details a radiofrequency (RF) ablation catheter equipped with a fluid-cooled active electrode. The invention primarily focuses on temperature control during RF ablation to achieve specific lesion sizes or prevent overheating.
• Potential Anticipation (under 35 U.S.C. § 102): This prior art pertains to the treatment device itself and its operational characteristics, particularly in the context of RF ablation. It could potentially anticipate aspects of the "active element" (102) and "treatment probe" (100) described in US12303166, especially if US12303166's preferred RF probe incorporates fluid cooling. However, this document does not address the primary inventive concepts of US12303166, which are the unique systems and methods for accessing the nerve within bone via a predictable curved path (Embodiments 1, 10, and the kit aspect).

6. US20090259220A1

• Full Citation: US20090259220A1, Intraosseous nerve ablation systems and methods, by Richard Pellegrino, Samit Patel, and Harold Carrison, published October 15, 2009.
• Publication/Filing Date: Published October 15, 2009.
• Brief Description: This publication describes comprehensive systems and methods specifically for the ablation of intraosseous nerves, including the basivertebral nerve (BVN), covering the procedural aspects of treating such nerves.
• Potential Anticipation (under 35 U.S.C. § 102): This publication, also by the same inventors, addresses an inventive goal highly similar to US12303166: "intraosseous nerve ablation systems and methods." Its publication date (October 15, 2009) is after the priority date of US12303166 (September 26, 2008). Therefore, it would only constitute 35 U.S.C. § 102 prior art if its effective filing date precedes September 26, 2008. If so, it could potentially anticipate the overall method of therapeutically treating a vertebral body by inserting an energy device and delivering energy to denervate the BVN, as described in one aspect of US12303166's summary. It might also detail the specific treatment location (e.g., between the BVN junction and the outer cortical bone), which is also a feature in US12303166.

7. US20100087823A1

• Full Citation: US20100087823A1, Steerable stylet assembly, by Richard Pellegrino, Samit Patel, and Harold Carrison, published April 8, 2010.
• Publication/Filing Date: Published April 8, 2010.
• Brief Description: This publication describes an assembly for a steerable stylet, likely designed for insertion into a cannula or introducer to facilitate navigation through various tissues, including bone, by means of a controllable tip.
• Potential Anticipation (under 35 U.S.C. § 102): Similar to other applications by the same inventors, the publication date of this document (April 8, 2010) is after the priority date of US12303166. Therefore, it would only be considered 35 U.S.C. § 102 prior art if its effective filing date is earlier than September 26, 2008. If it qualifies as prior art, the concept of a "steerable stylet assembly" could potentially anticipate the "curved stylet" (60) and the "straightening stylet" (40) described in US12303166, which are critical components for defining and maintaining the curved path. This would be relevant to the device features in Embodiment 1 and the procedural steps involving these stylets in Embodiment 10.

Obviousness Analysis of US Patent 12303166 under 35 U.S.C. § 103

This analysis assesses the obviousness of US Patent 12303166 ("Methods for accessing nerves within bone") under 35 U.S.C. § 103, based on the provided "Prior art" section and the described "inventive embodiments" (acting as proxies for claims). A person having ordinary skill in the art (PHOSITA) in this field would likely be a medical device engineer or a surgeon experienced in minimally invasive spinal or orthopedic procedures. This PHOSITA would be familiar with spinal anatomy, challenges in navigating instruments through bone (including cancellous bone with varying densities), properties of materials like Nitinol and PEEK, standard steerable instrument design principles, nerve ablation techniques, and the need for precise surgical delivery.

The core inventive concepts of US12303166, as outlined in the "inventive embodiments," include:

• A system for channeling a predictable, curved path into bone using a trocar and a curved cannula (Embodiment 1).
• A method for using this system, including the subsequent creation of a straight channel for a treatment device (Embodiment 10).
• A kit providing cannulas with varying preformed curvatures (Another Aspect).
• Specific components like straightening stylets, curved stylets (with angled tips for maintaining curvature and piercing bone), and straight channeling stylets that deform to navigate curves but retain a straight form upon exiting.

Combinations of Prior Art References and Motivation to Combine

Several combinations of the identified prior art, along with general knowledge in the field, would likely render the key aspects of US12303166 obvious to a PHOSITA.

1. WO2008039234A2 (Pellegrino et al.) in combination with general knowledge of steerable instrument design, material science, and surgical needs.

• WO2008039234A2 ("System and method for creating a steered path in bone"), published April 3, 2008: This document, by the same inventors as US12303166 and published before US12303166's priority date of September 26, 2008, directly teaches a "system and method for creating a steered path in bone," specifically for accessing nerves within the spine using an introducer (trocar) and a steerable instrument (stylet or cannula). This reference squarely addresses the fundamental concept of creating a non-linear path in bone to reach an anatomical target, thereby making broad aspects of US12303166's Embodiments 1 and 10 obvious.

• Motivation to combine with general knowledge:

  • Predictable Curved Path: The background of US12303166 explicitly notes the difficulty of navigating a probe in bone and ensuring precise positioning due to "varying densities of bone." Given WO2008039234A2's objective of creating a "steered path" for precise nerve access, a PHOSITA would be highly motivated to make this steering predictable and less susceptible to variations in bone density. The use of a pre-formed curved cannula made of a shape-memory material (e.g., Nitinol, as discussed in US12303166) that is straightened by an outer rigid trocar during insertion and then allowed to regain its preformed curve upon exiting is a well-known engineering principle in medical device design for creating predictable, controlled curves in steerable instruments. This would render the "deflectable tip with a preformed curve such that the tip straightens while being delivered through the trocar and regains its preformed curve upon exiting" obvious.
  • Straight Channel after the Curve: Many therapeutic devices, such as the RF probes mentioned in US12303166, typically have straight active elements that require stable, linear access for precise energy delivery. A PHOSITA, having used the principles from WO2008039234A2 to create a curved path to reach a target area, would be motivated to ensure a stable, linear final approach for accurate placement and activation of such a treatment device. Creating a distinct "straight channeling stylet" (as described in US12303166) that is flexible enough to navigate the curved cannula but rigid enough (e.g., made of PEEK, as specified in US12303166) to create a linear working channel in cancellous bone upon exiting is a logical engineering solution to achieve this precise terminal access.
  • Kit with Varying Curvatures: The need to accommodate varying patient anatomies and different target locations (e.g., BVN in lumbar versus cervical vertebrae) is a well-understood clinical reality, as even acknowledged by US12303166. A PHOSITA, aiming to provide a versatile and commercially viable surgical solution based on WO2008039234A2's steered path, would find it obvious to offer a kit containing instruments with a range of preformed curvatures (varying radii, angles, and lengths) to match diverse anatomical requirements and surgical approaches. This is a standard practice in the medical device industry for customization.

• Conclusion for Combination 1: This combination renders obvious the systems and methods for creating a predictable curved path in bone, the creation of a subsequent straight channel, and the provision of a kit with varying curvatures, as described in US12303166's inventive embodiments.

2. Combination 1 + US6699242B1 (Treat) or US20080183204A1 (Davenport et al.)

• WO2008039234A2 (Pellegrino et al.): As established, this teaches accessing nerves within bone via a steered path.

• US6699242B1 ("Tissue ablation system and methods"), issued March 4, 2003: This patent describes systems and methods for tissue ablation, often using radiofrequency (RF) energy. US12303166 itself cites this patent in its detailed description regarding the ablation of tissue.

• US20080183204A1 ("Radiofrequency ablation catheter with fluid cooled active electrode"), published August 7, 2008: This document, published before US12303166's priority date, details an RF ablation catheter, specifically featuring a fluid-cooled active electrode for temperature control during ablation.

• Motivation to combine: A PHOSITA, having a system and method for precisely accessing intraosseous nerves (from WO2008039234A2), would be strongly motivated to combine this access technology with a known and effective means of treating those nerves. Both US6699242B1 and US20080183204A1 provide details on RF ablation, a common and effective modality for nerve treatment. The ultimate goal of accessing the basivertebral nerve (BVN) in US12303166 is therapeutic treatment, often ablation or denervation. Therefore, combining the access methodology with an ablation device and method is a straightforward and desirable integration to achieve a functional medical procedure. This combination would render obvious the delivery of a treatment device, such as an RF probe, through the channeled path to denervate the BVN, as described in US12303166.

3. Kopecky et al. (Side-exiting coaxial needle) in combination with WO2008039234A2 and general knowledge.

• Kopecky et al. (1996) ("Side-Exiting Coaxial Needle for Aspiration Biopsy"): This paper describes a system where a smaller needle is deflected by a ramp inside a guide needle to exit through a side hole.

• WO2008039234A2 (Pellegrino et al.): Teaches creating a steered path in bone.

• Motivation to combine: While US12303166 distinguishes itself from Kopecky by emphasizing predictable linear exit and navigation, the general concept of deflecting an inner instrument from a main guide to achieve non-linear access is present in Kopecky. A PHOSITA seeking to implement a "steered path" as taught by WO2008039234A2 might consider various mechanisms for steering or deflecting instruments. Kopecky presents one such mechanism for achieving non-linear access. Although Kopecky's specific mechanism might lack the desired predictability in bone, the underlying idea of using an inner, deflectable element in a coaxial system to create a non-linear path is a known starting point that a PHOSITA would improve upon with known engineering solutions (e.g., Nitinol properties, specific stylet designs) to address the predictability issues. This could lead to the concept of a deflectable tip cannula in WO'234, where the deflection is controlled and predictable.

Additional Considerations for Other Prior Art by Same Inventors

The other "Pellegrino et al." prior art documents (US20080275460A1, US20090099566A1, US20090259220A1, US20100087823A1), while having publication dates later than the priority date of US12303166, explicitly address very similar subject matter (steered paths in bone, radiofrequency nerve ablation, intraosseous nerve ablation systems, steerable stylet assemblies) and share the same inventors. If their effective filing dates precede September 26, 2008, they would also constitute prior art. In such a scenario, these documents would further reinforce the obviousness arguments by providing even more specific teachings of the components (e.g., steerable stylets, RF probes for nerve ablation) and methods that US12303166 claims, making their combination with WO2008039234A2 and general knowledge even more compelling to a PHOSITA, as they represent a natural evolution or related work by the same inventive entity.

To determine the patent term adjustments (PTA), patent term extensions (PTE), continuation applications, divisional applications, related family members, and the projected expiration date for US Patent 12303166, I will use the information available from Google Patents and general USPTO rules regarding patent term. The current date is April 26, 2026.

Based on the information, here's a detailed breakdown:

Patent Term Adjustments (PTA)

Patent Term Adjustment (PTA) is granted to compensate for delays caused by the USPTO during the prosecution of a patent application. It adds days to the 20-year term from the earliest non-provisional filing date. The USPTO automatically determines PTA and provides a notice of this determination by the patent's issue date.

The Google Patents page for US12303166 indicates a filing date of 2024-07-19 and a publication date (and grant date) of 2025-05-20. The time from filing to grant is less than one year, specifically about 10 months. While the patent was granted on May 20, 2025, the Google Patents page currently does not display a specific PTA amount. To get the precise PTA, one would typically need to check the official USPTO Patent Center for the patent's full prosecution history and the PTA calculation. However, given the relatively short pendency period from filing to issuance (less than 36 months, which is a key benchmark for B-delay PTA), it's possible the PTA would be minimal or none, assuming the USPTO met its other statutory deadlines (e.g., issuing a first office action within 14 months, responding to replies within 4 months).

Patent Term Extensions (PTE)

Patent Term Extension (PTE) is available under the Hatch-Waxman Act (35 U.S.C. § 156) for patents claiming products (human drugs, food/color additives, medical devices, animal drugs, and veterinary biological products) that require regulatory approval, to compensate for time lost during the regulatory review process. The application for PTE must be filed within 60 days of the marketing approval date.

Given that US12303166 relates to medical methods and devices for accessing nerves within bone, particularly for basivertebral nerve (BVN) ablation, it falls into the category of patents potentially eligible for PTE due to regulatory review by agencies like the FDA. However, the provided patent information and Google Patents page for US12303166 do not indicate that an application for PTE has been filed or granted. Without this information from the USPTO or FDA records, it cannot be confirmed whether a PTE has been applied to this patent.

Continuation and Divisional Applications

The patent text itself indicates that "This application is a continuation of U.S. patent application Ser. No. 16/368,453, filed on Mar. 28, 2019, which is a continuation of U.S. patent application Ser. No. 15/040,268, filed on Feb. 10, 2016, issued as U.S. Pat. No. 10,265,099, which is a continuation of U.S. patent application Ser. No. 13/862,242 filed on Apr. 12, 2013, issued as U.S. Pat. No. 9,259,241, which is a continuation of U.S. patent application Ser. No. 12/566,895 filed on Sep. 25, 2009, issued as U.S. Pat. No. 8,419,730, which claims the benefit of U.S. Provisional Application 61/100,553 filed on Sep. 26, 2008." This establishes a clear chain of continuation applications.

• Provisional Application: US Provisional Application 61/100,553 filed on Sep. 26, 2008.
• Non-Provisional Applications (Continuation Chain):
  1. U.S. patent application Ser. No. 12/566,895 filed on Sep. 25, 2009, issued as U.S. Pat. No. 8,419,730.
  2. U.S. patent application Ser. No. 13/862,242 filed on Apr. 12, 2013, issued as U.S. Pat. No. 9,259,241.
  3. U.S. patent application Ser. No. 15/040,268, filed on Feb. 10, 2016, issued as U.S. Pat. No. 10,265,099.
  4. U.S. patent application Ser. No. 16/368,453, filed on Mar. 28, 2019.
  5. US18/778,387 (the application for US12303166B2), filed on 2024-07-19.

No specific divisional applications are explicitly mentioned for US12303166 in the provided text. Divisional applications arise when an original application claims two or more independent and distinct inventions, and the USPTO requires restriction to one invention, with the other invention forming the basis of a new, "divisional" application.

Related Family Members

The related family members are those identified in the continuation chain:

• US Provisional Application 61/100,553
• US Pat. No. 8,419,730
• US Pat. No. 9,259,241
• US Pat. No. 10,265,099
• U.S. patent application Ser. No. 16/368,453
• US20240366265A1 (publication of US18/778,387)
• US20250275787A1 (priority to US19/212,313)
• US20260076715A1 (priority to US19/399,248)

These form a patent family stemming from the initial provisional application.

Projected Expiration Date

For utility patents filed on or after June 8, 1995, the patent term generally expires 20 years from the earliest non-provisional filing date, with any PTA added to this term. US12303166 claims benefit from a chain of applications going back to a provisional application filed on September 26, 2008. The earliest non-provisional application in this chain is U.S. patent application Ser. No. 12/566,895, filed on September 25, 2009.

Therefore, the base patent term is 20 years from September 25, 2009.
Base expiration date: September 25, 2009 + 20 years = September 25, 2029.

The Google Patents page explicitly lists "Anticipated expiration: 2029-09-25". This date is consistent with the 20-year term from the earliest non-provisional filing date in its priority chain, assuming no significant PTA or PTE. As noted earlier, the specific PTA is not provided in the readily available Google Patents data, and no PTE is explicitly mentioned. Therefore, based on the current information, the projected expiration date is September 25, 2029.

Defensive Disclosure: Derivatives of US Patent 12303166

This defensive disclosure aims to broaden the prior art landscape surrounding US Patent 12303166, "Methods for accessing nerves within bone," by detailing a range of derivative variations. These variations are designed to encompass foreseeable incremental improvements by competitors, thereby making such advancements obvious or non-novel to a person having ordinary skill in the art (PHOSITA). The focus is exclusively on generating new technical disclosures based on the core inventive embodiments of the patent, without restating or summarizing the existing patent content.

---

Derivatives of Core Inventive Embodiment 1: System for Channeling a Path into Bone

Original Core Concept (as derived from "inventive embodiment 1"): A system comprising a trocar having a central channel and opening at its distal tip, and a curved cannula sized to be received in said central channel and delivered to said distal opening. The cannula has a deflectable tip with a preformed curve such that the tip straightens while being delivered through the trocar and regains its preformed curve upon exiting and extending past the distal opening of the trocar to generate a curved path in the bone corresponding to the preformed curve of the deflectable tip. The cannula comprises a central passageway having a diameter configured to allow a treatment device to be delivered through the central passageway to a location beyond the curved path.

1. Material & Component Substitution

Enabling Description: The elongate shaft of the trocar (28) is manufactured from a unidirectional carbon fiber reinforced polymer (CFRP) composite, specifically a high-modulus, aerospace-grade prepreg laid up in a [0/90/+45/-45]s sequence to optimize torsional stiffness (exceeding 50 GPa) and bending strength. The distal piercing tip (22) is fabricated from a medical-grade tungsten carbide alloy (e.g., WC-Co cemented carbide with 6-8% cobalt binder) with a 2-5 micron thick diamond-like carbon (DLC) coating applied via Plasma-Enhanced Chemical Vapor Deposition (PECVD) to achieve a coefficient of friction below 0.15 against cortical bone and a Vickers hardness exceeding 2000 HV, thereby enhancing piercing efficiency and reducing wear. The curved cannula (50) is constructed from a bi-layer shape-memory polymer (SMP), where the inner layer is a cross-linked polyurethane-based SMP (e.g., designed with a glass transition temperature (Tg) of 50-60°C) and the outer layer is a lubricious polytetrafluoroethylene (PTFE) coating. Embedded within the SMP layer, along its length, is a resistively heated NiCr micro-coil (200-500 microns diameter) connected to external current leads via micro-contacts. By applying a controlled current (e.g., 0.1-0.5A at 5-10V), the temperature of the SMP can be transiently increased above its Tg, allowing active shape-setting (e.g., dynamically tightening or loosening the curve) or rapid retraction to a straightened state within the trocar. Upon cooling below Tg, the cannula locks into the new shape or original pre-set curve. The straightening stylet (40) and curved stylet (60) are fabricated from a polylactic acid (PLA) matrix composite reinforced with 20 wt% hydroxyapatite (HA) nanoparticles (e.g., 50-100 nm diameter). These biodegradable stylets are designed to maintain rigidity during deployment (flexural modulus > 3 GPa) but degrade bio-resorbably over 2-6 weeks post-implantation, reducing the need for secondary removal procedures if fragments remain. The treatment device (100) comprises a flexible fiber optic catheter, containing a 0.5 mm diameter holmium:YAG laser fiber, delivered through the central passageway (54). The laser operates at 2100 nm, pulsed at 10-20 Hz with 0.5-2.0 J/pulse, providing highly localized thermal ablation. Alternatively, a miniature phased array ultrasonic transducer (e.g., 2-5 MHz frequency, 64-element array) on the distal end of the catheter is capable of focused high-intensity focused ultrasound (HIFU) for non-invasive thermal ablation, achieving focal temperatures up to 80°C.

classDiagram
    class Trocar {
        +ElongateShaft: CFRP_Composite
        +DistalTip: WC-Co/DLC_Coating
        +CentralLumen: PTFE_Lined
    }
    class CurvedCannula {
        +Body: SMP_Bi-layer/NiCr_Microcoil
        +OuterCoating: PTFE
        +DeflectableTip: SMP_Active
    }
    class Stylets {
        +Material: PLA/HA_Nanocomposite
        +Function: Bio-resorbable_Channeling
    }
    class TreatmentDevice {
        +Type: Fiber_Optic_Laser_Catheter
        +Type: HIFU_Transducer_Array
        +Modality: Laser_Ablation
        +Modality: Ultrasound_Ablation
    }
    Trocar <-- CurvedCannula : contains
    CurvedCannula <-- Stylets : internal_support
    CurvedCannula <-- TreatmentDevice : delivers

2. Operational Parameter Expansion

Enabling Description: The system is miniaturized for accessing sub-millimeter nerves within intricate bone structures such as the inner ear or craniofacial bones. In this micro-scale configuration, the trocar (20) shaft (28) is reduced to a 1.5 mm outer diameter (18-gauge equivalent), with a central lumen (36) of 0.8 mm. The curved cannula (50) has an outer diameter of 0.7 mm, with a deflectable Nitinol tip (56) having a preformed radius of curvature (r) as small as 0.1 mm, achieving angles (Θ) up to 180 degrees over a 2 mm deployment length. This enables precise navigation through trabecular bone in delicate anatomical regions (e.g., petrous bone for facial nerve access or temporal bone for cochlear nerve access). The treatment device (100) is a 0.3 mm diameter micro-RF probe with 0.1 mm bipolar electrodes or a neurochemical delivery micro-catheter with a 0.2 mm outer diameter, capable of delivering picoliter volumes of agents. For high-power bone remodeling, the system is scaled up for procedures requiring larger volume bone resection. The trocar (20) has a 10 mm outer diameter, and the curved cannula (50) incorporates a rotatable, helical cutting burr (e.g., made of high-speed steel with diamond grit coating) on its distal tip. The burr is driven by an internal micro-motor (e.g., brushless DC motor) at 50,000-100,000 RPM, capable of rapidly resecting cancellous bone (removal rate of 1-5 mm/second) and sculpting cortical bone (up to 0.5 mm/second). The system integrates continuous saline irrigation (5-10 ml/min) and aspiration (vacuum of -50 to -100 mmHg) for efficient debris management, enabling the creation of channels up to 8 mm in diameter. Furthermore, piezoelectric force sensors (e.g., PZT patches, 1x1mm) are integrated into the distal 5 cm of the curved stylet (60) and the tip of the curved cannula (50), providing real-time axial and lateral force feedback with a sensitivity of 0.1 N at 100 Hz. This feedback is transmitted to haptic actuators (e.g., voice coil linear actuators, 10-100 N force range) in the handle (24) of the trocar and/or stylets, providing tactile cues to the surgeon regarding encountered bone density and resistance, allowing for dynamic adjustment of insertion force and rotational torque to maintain the desired curvature (r) and angle (Θ).

graph TD
    A[Surgeon Applies Force/Torque] --> B{Force/Torque Sensors on Stylet/Cannula};
    B --> C{Measure Axial, Lateral Force & Torsional Torque};
    C --> D{Transmit Data to Control Unit (e.g., via wired/wireless link)};
    D --> E{Process Sensor Data & Bone Density Model Update};
    E --> F{Generate Haptic Feedback Signal (Amplitude/Frequency)};
    F --> G[Haptic Actuators in Handle Provide Tactile Cues/Resistance];
    G --> H{Surgeon Adjusts Insertion/Rotation Parameters};
    H --> B;
    style A fill:#D6EAF8,stroke:#1A5276,stroke-width:2px;
    style G fill:#D6EAF8,stroke:#1A5276,stroke-width:2px;

3. Cross-Domain Application

Enabling Description:

• Aerospace - In-situ Repair of Composite Structures: A specialized composite-penetrating trocar (20 equivalent), fabricated from hardened tool steel with a carbide-tipped distal end, and a central channel (36) is designed for navigating multi-layer carbon fiber reinforced polymer (CFRP) composite structures (e.g., aircraft wing spars, fuselage sections). The curved cannula (50 equivalent) is formed from a high-strength, flexible polymer (e.g., PEEK-reinforced polyimide braid with a shore hardness of 80D) with a pre-set curvature (56) that straightens within the trocar and regains its curve upon exiting into the composite material. This cannula guides a fiber optic borescope (e.g., 1mm diameter, 0.2mm pixel resolution), an ultrasonic transducer (e.g., 10 MHz pulse-echo), or a two-part epoxy resin injection catheter (e.g., 0.5mm lumen, 1-5 ml/min flow rate) to internal delaminations, fatigue cracks, or void regions within the composite. This enables targeted repair or inspection without requiring large external access ports, minimizing structural degradation.

graph TD
    A[Identify Composite Damage/Target Zone (NDT Scan)] --> B{Insert Composite Trocar into Structure};
    B --> C{Deploy Pre-Curved Polymer Cannula from Trocar};
    C --> D{Cannula Forms Curved Path to Damage Site};
    D --> E{Insert Inspection/Repair Tool via Cannula};
    E --> F[Perform Fiber Optic Borescopy / Ultrasonic Scan / Resin Injection];
    F --> G{Withdraw Tools & Seal Access Port};

• AgriTech - Root Zone Monitoring/Intervention: A soil-penetrating introducer (trocar 20 equivalent), with a hardened stainless steel shaft (e.g., 10mm OD) and a replaceable auger tip (e.g., helical flight, 20mm pitch), is used to create an initial access channel through compacted soil. A flexible, curved soil-cannula (50 equivalent) made of a reinforced, biocompatible polymer (e.g., HDPE with aramid fiber braiding, 8mm OD) is then deployed. The cannula's preformed curve, controlled by a removable stylet (60 equivalent) with an internal vibratory element (e.g., eccentric mass motor, 100-200 Hz), allows it to navigate around obstructions like large stones or primary roots, following a pre-programmed path to target specific root nodules or soil horizons up to 1 meter deep. Through the cannula, miniaturized IoT soil sensors (e.g., capacitance-based moisture sensor, ion-selective electrodes for pH/nutrient levels) or micro-drip emitters for precision fertilization (e.g., 1-5 ml/hour) are deployed.

sequenceDiagram
    Soil_Surface->>Introducer: Initial Penetration (Auger Tip)
    Introducer->>Soil_Mass: Access Channel Created (50-100 cm depth)
    Introducer->>Curved_Cannula: Insert Soil Cannula with Vibratory Stylet
    Curved_Cannula-->>Soil_Mass: Deploy Curved Path (Vibration-Assisted Navigation)
    Curved_Cannula->>Root_Zone_Target: Reach Target (e.g., 10-20 cm lateral offset)
    Curved_Cannula->>Sensor_Module: Deploy IoT Soil Sensor/Micro-Drip Emitter
    Sensor_Module->>Root_Zone_Target: Monitor Environmental Params / Deliver Nutrients
    Curved_Cannula->>Introducer: Retract Cannula
    Introducer->>Soil_Surface: Withdraw Introducer

• Consumer Electronics - Micro-Cable Routing in Complex Devices: A robotic arm manipulates a miniature trocar (20 equivalent, <1 mm outer diameter) to gain initial access through a pre-drilled micro-port in a device casing. A flexible, pre-curved micro-cannula (50 equivalent, <0.5 mm outer diameter) made of a superelastic Nitinol alloy is then deployed. The cannula's curvature is precisely controlled by an external electromagnetic field (e.g., localized 50-100 mT field) acting on embedded ferromagnetic elements (e.g., FeNi micro-particles) along its length, instead of a mechanical stylet. This allows the cannula to navigate around internal components and through tortuous, pre-defined pathways (e.g., 0.6 mm wide channels) to reach target connector points within miniaturized electronic devices (e.g., smart watches, AR/VR headsets). A flexible micro-cable (e.g., 0.2 mm diameter, 8-conductor) with a miniature connector (e.g., 0.4 mm pitch FPC connector) is subsequently pushed through the cannula and automatically connected via a robotic pick-and-place mechanism.

graph LR
    A[Robotic Arm] -- controls --> B(Miniature Trocar)
    B -- inserts into --> C(Device Casing/Pre-drilled Port)
    C -- guides --> D(Flexible Micro-Cannula)
    D -- navigates via --> E{External Electromagnetic Field}
    D -- routes through --> F(Complex Internal Pathways)
    F -- reaches --> G(Target Connector Point)
    D -- delivers --> H(Micro-Cable with Connector)
    G -- enables --> I(Automated Connection/Bonding)

4. Integration with Emerging Tech

Enabling Description:

• AI-driven Optimization: Pre-operative 3D computed tomography (CT) scans (e.g., 0.2mm isotropic voxel size) of the vertebral body are fed into a deep learning neural network (e.g., a 3D U-Net architecture for bone and nerve segmentation, followed by a Graph Neural Network for optimal pathfinding) to generate a patient-specific, optimal curved trajectory for basivertebral nerve (BVN) access. This trajectory minimizes cortical bone removal, avoids critical structures (e.g., spinal canal), and optimizes for instrument mechanics. During the procedure, real-time fluoroscopic imaging (e.g., 15 frames/sec) and integrated piezoelectric force sensors (0.1 N sensitivity) on the cannula and stylet provide continuous data streams to a real-time AI algorithm. This AI, based on a reinforcement learning model, dynamically adjusts the speed of cannula/stylet advancement (e.g., 0.1-1.0 mm/s), rotational orientation (e.g., 1-10 degrees/s), and micro-actuations in the stylet's deflectable tip (if active materials are used) to maintain the optimal path despite encountered bone density variations, ensuring predictable and precise navigation with a target deviation of <0.5 mm.

sequenceDiagram
    Participant Surgeon
    Participant Imaging_System_Preop
    Participant AI_Planning_System
    Participant Surgical_Robot_Control
    Participant Instrument_System_Realtime
    Participant Imaging_System_Intraop

    Surgeon->>Imaging_System_Preop: Order Pre-op 3D CT/MRI
    Imaging_System_Preop->>AI_Planning_System: Transmit 3D Anatomical Data (DICOM)
    AI_Planning_System->>AI_Planning_System: Generate Patient-Specific Optimal Curved Path (DL/GNN)
    AI_Planning_System->>Surgical_Robot_Control: Transmit Initial Path & Dynamic Parameters
    Surgical_Robot_Control->>Instrument_System_Realtime: Initiate Procedure (Trocar Insertion)
    loop Real-time Navigation & Optimization
        Instrument_System_Realtime->>Surgical_Robot_Control: Send Force/Position Data (Embedded Sensors)
        Imaging_System_Intraop->>Surgical_Robot_Control: Send Real-time Fluoroscopy/CT
        Surgical_Robot_Control->>AI_Planning_System: Forward Sensor & Imaging Data
        AI_Planning_System->>AI_Planning_System: Evaluate Path Deviation & Bone Density (RL Model)
        AI_Planning_System->>Surgical_Robot_Control: Send Adjusted Deployment Parameters (Speed, Rotation, Micro-Actuations)
        Surgical_Robot_Control->>Instrument_System_Realtime: Execute Adjustments
    end
    AI_Planning_System->>Surgeon: Display Real-time Path & Status Overlay (AR)

• IoT Sensors for Real-time Monitoring: The curved cannula (50) and curved stylet (60) are fabricated with integrated fiber Bragg grating (FBG) sensors (e.g., 1550 nm wavelength, 10 cm gauge length) arrayed along their deflectable tips and shafts at 1 cm intervals. These FBGs provide real-time, distributed strain and temperature measurements with a spatial resolution of 1 mm and a temporal resolution of 100 Hz. Additionally, miniature micro-electromechanical systems (MEMS) accelerometers (e.g., <2x2x1 mm, ±16g range) are embedded at 5 mm intervals along the distal 10 cm to detect subtle vibrations (e.g., >500 Hz) indicating bone engagement characteristics or incipient structural stress. Data from these sensors is wirelessly transmitted (e.g., via a custom low-power radio frequency protocol or Bluetooth Low Energy (BLE) at 2.4 GHz) to a surgical console. The console displays real-time curvature profiles, localized force maps, and temperature readings on a heads-up display (HUD) for the surgeon, and feeds this data to the AI system for active navigation control and safety monitoring.

classDiagram
    class CurvedCannula {
        +FiberBraggGratingSensors: Strain, Temperature (1mm spatial res)
        +MEMS_Accelerometers: Vibration, Bone_Engagement (>500Hz)
        +WirelessTransmitter: BLE/Custom_RF (100Hz temporal res)
    }
    class CurvedStylet {
        +FiberBraggGratingSensors: Strain, Temperature
        +MEMS_Accelerometers: Vibration
        +WirelessTransmitter: BLE/Custom_RF
    }
    class SurgicalConsole {
        +Receiver: BLE/Custom_RF
        +DataProcessor: Real-time_Analysis (e.g., FPGA-based)
        +Display: HUD/AR_Overlay
        +Alert_System: Audible/Visual_Thresholds
    }
    CurvedCannula "1" -- "1" SurgicalConsole : transmits_sensor_data_to
    CurvedStylet "1" -- "1" SurgicalConsole : transmits_sensor_data_to
    SurgicalConsole "1" -- "1" AI_Control_System : forwards_processed_data_to

• Blockchain for Supply Chain Verification & Surgical Log: Each component (trocar 20, cannula 50, stylets 40, 60, 90) is tagged with a unique serialized identifier (e.g., a cryptographically signed 2D Data Matrix code). At each critical stage of manufacturing (e.g., material batch validation, Nitinol heat-setting parameters), sterilization (e.g., ethylene oxide cycle parameters, expiration date), and distribution (e.g., shipping temperature logs, custody transfers), relevant parameters are recorded and timestamped as transactions on a permissioned blockchain network (e.g., Hyperledger Fabric or enterprise Ethereum). Prior to surgery, instrument IDs are scanned, and their authenticity, integrity, and regulatory compliance (e.g., FDA clearance status) are verified against the blockchain ledger, preventing the use of counterfeit or compromised instruments. Post-procedure, key surgical parameters (e.g., actual vs. planned path deviation, delivered energy by treatment device, procedure duration, surgeon ID, and any adverse events) are cryptographically signed by the surgeon and appended to the patient's electronic health record (EHR) and a separate immutable blockchain-based surgical log. This provides secure, auditable trails for patient safety, regulatory reporting, and retrospective performance analytics.

sequenceDiagram
    Participant Manufacturer
    Participant Sterilization_Facility
    Participant Distributor
    Participant Hospital_Supply_Chain
    Participant Surgical_Team
    Participant Blockchain_Network

    Manufacturer->>Blockchain_Network: Record Instrument_ID & Mfg_Params
    Sterilization_Facility->>Blockchain_Network: Record Sterilization_Batch & Expiry
    Distributor->>Blockchain_Network: Record Shipping_Log & Temp_Telemetry
    Hospital_Supply_Chain->>Blockchain_Network: Record Receipt & Inventory_Status
    Surgical_Team->>Hospital_Supply_Chain: Retrieve Surgical Instruments
    Surgical_Team->>Blockchain_Network: Verify_Instrument_Authenticity (Scan ID)
    Surgical_Team->>Blockchain_Network: Record_Surgical_Parameters (Post-Procedure Log)
    Surgical_Team->>EHR_System: Update Patient EHR (FHIR/DICOM Link)

5. The "Inverse" or Failure Mode

Enabling Description: The deflectable tip (56) of the curved cannula (50) is fabricated from a Nitinol alloy with a superelastic transition temperature slightly above body temperature (e.g., 40-42°C). The initial preformed curve is set at room temperature. Upon reaching its operational environment in the body, the cannula's tip will naturally attempt to regain a straightened configuration (stress-induced martensitic transformation) if external forces (e.g., excessive bone resistance >5N, torsional stress >0.5 Nm) exceed a predefined threshold. This passive straightening prevents further advancement in an uncontrolled curved path. Additionally, a sacrificial shear pin (e.g., 0.5 mm diameter medical-grade titanium alloy) or a segmented Nitinol wire (e.g., 0.1 mm diameter with pre-engineered stress concentration points) is incorporated into the stylet (60) or the cannula deployment mechanism. This pin/wire is designed to intentionally fracture or detach if a torsional or axial force on the instrument exceeds 80% of its critical fracture limit (e.g., 10N axial, 1Nm torsional), thereby decoupling the active drive from the distal tip. This decoupling allows passive retraction (due to the cannula's inherent superelasticity) and prevents catastrophic instrument breakage in situ, minimizing patient harm. The system also includes an acoustic emission sensor (e.g., PZT transducer, 100-500 kHz) on the handle to detect micro-fractures in the bone or the instrument.

stateDiagram
    [*] --> Idle_Ready
    Idle_Ready --> Trocar_Inserted
    Trocar_Inserted --> Cannula_Deployed_Straight
    Cannula_Deployed_Straight --> Curved_Path_Formation: Activate Deployment Mechanism
    Curved_Path_Formation --> Curved_Path_Maintained: (Measured Forces < Thresholds)
    Curved_Path_Maintained --> Self_Straighten_Retract: Event: (Excessive_Force OR Material_Fatigue OR Loss_of_Control OR Acoustic_Emission_Anomaly)
    Curved_Path_Formation --> Self_Straighten_Retract: Event: (Excessive_Force OR Material_Fatigue OR Loss_of_Control OR Acoustic_Emission_Anomaly)
    Self_Straighten_Retract --> Fail_Safe_Retracted: Passive Retraction & Energy Cutoff
    Fail_Safe_Retracted --> [*]

---

Derivatives of Core Inventive Embodiment 10: Method for Channeling a Path into Bone

Original Core Concept (as derived from "inventive embodiment 10"): A method for channeling a path into bone to a treatment location in the body of a patient, comprising: inserting a trocar having a central channel and opening at its distal tip into a region of bone at or near the treatment location; delivering a cannula through said central channel and to said distal opening, wherein the cannula comprises a deflectable tip with a preformed curve such that the tip straightens while being delivered through the trocar and regains its preformed curve upon exiting the trocar; extending the cannula past the distal opening of the trocar to generate a curved path in the bone corresponding to the preformed curve of the deflectable tip; and delivering a treatment device through a central passageway in said cannula to the treatment location beyond the curved path.

1. Material & Component Substitution (Methodological Implications)

Enabling Description: The method involves using a curved cannula (50) constructed from a soft robotic compliant mechanism incorporating multiple miniaturized piezoelectric stack actuators (e.g., PZT-5H, 1x1x2mm elements) or electroactive polymer (EAP) segments (e.g., dielectric elastomer actuators) along its distal 10 cm. After the initial trocar insertion, the cannula is advanced. Instead of passively regaining its curve, a closed-loop control system dynamically energizes specific actuators (e.g., 50-200V for piezoelectric, 1-5 kV for EAP) to generate and precisely adjust the radius of curvature (r) (e.g., 0.1 to 1.0 inch) and angle (Θ) (e.g., 0 to 180 degrees) in real-time. This active shape control enables dynamic "steering" of the curve through cancellous bone, guided by intra-operative imaging and sensor feedback. The initial step of "inserting a trocar into a region of bone" is augmented. A focused ultrasound transducer, integrated coaxially within the trocar (20) or as an initial pilot instrument, delivers high-intensity focused ultrasound (HIFU) at 1-5 MHz with pulse durations of 10-100 ms to ablate a precise, small-diameter (<2 mm) pilot hole through the cortical bone (128) and into the cancellous bone (124). Alternatively, a pulsed femtosecond laser (e.g., 1030 nm wavelength, 100 fs pulse width, 10-50 µJ/pulse) delivered via a fiber optic through the trocar, is used to optically ablate the initial bone path with minimal thermal collateral damage (heat affected zone <50 microns). After "extending the cannula past the distal opening of the trocar to generate a curved path in the bone," but before delivering the treatment device, a biodegradable, self-setting hydrogel precursor solution (e.g., a two-part system of aldehyde-modified hyaluronic acid and hydrazide-modified polyethylene glycol) is injected through a side port of the cannula (50) into the newly formed curved bone path (144) at a flow rate of 0.5-2.0 ml/min. The gel polymerizes in situ within 30-60 seconds, creating a temporary, lubricious, and biomechanically supportive lining that prevents channel collapse or tissue ingrowth, and ensures stable delivery of the subsequent treatment device. The gel gradually degrades over 24-72 hours via enzymatic hydrolysis.

graph TD
    A[Insert Trocar (Pre-Drill/HIFU/Laser Pilot)] --> B[Insert Actuator-Enabled Cannula];
    B --> C{Control System Dynamically Activates Actuators};
    C --> D[Advance Cannula, Actively Steering Curve into Bone];
    D --> E{Real-time Feedback (Sensors/Imaging)};
    E --> F{Control System Adjusts Actuators for Path Correction};
    F --> D;
    D -- Curved Path Formed --> G[Inject Biodegradable Hydrogel for Channel Stabilization];
    G --> H[Deliver Treatment Device];

2. Operational Parameter Expansion (Methodological Implications)

Enabling Description: The method utilizes a cryo-ablation tip integrated into a specialized cryo-cannula for creating the curved path. After inserting the trocar (20), the cryo-cannula, with its distal tip (56) designed for localized cryo-ablation, is inserted. The tip is actively cooled to below -60°C (e.g., using circulating liquid nitrogen or argon gas via Joule-Thomson expansion to maintain a 5mm cryo-lesion). This extreme cold induces localized brittle fracture and necrosis of the bone tissue (creating a frozen zone 3-5mm beyond the tip), allowing the cannula to advance and mechanically displace the frozen/fractured bone to create the curved path (144). The fractured bone fragments are then aspirated through the central lumen of the cannula. Prior to and during the step of "extending the cannula past the distal opening of the trocar to generate a curved path," a robotic C-arm computed tomography (CT) system performs continuous, low-dose 3D volumetric scans (e.g., 0.5mm slice thickness, 2-5 mGy dose). The acquired 3D data is immediately fed into an AI image processing pipeline that reconstructs the actual cannula tip position and the formed bone channel in real-time. This real-time 3D model is overlaid onto the pre-planned trajectory on the surgeon's augmented reality (AR) display, highlighting any deviations >0.5 mm. The AI then provides predictive guidance or automatically adjusts the robotic manipulator controlling the cannula advancement to maintain the desired path. For multi-segment path generation, the method employs an advanced steerable cannula system where the deflectable tip (56) has multiple independent bending segments (e.g., three segments, each controllable over 0-60 degrees deflection with 1-degree precision, actuated by pull wires). The method involves sequentially activating these segments and advancing the cannula in a coordinated fashion to create compound curves (e.g., an S-shape to bypass a critical spinal structure, followed by a linear segment), or even helical paths. The control system incorporates inverse kinematics to translate desired 3D path coordinates into specific bending angles and advancement distances for each segment, achieving a 3D path accuracy of <1.0 mm.

stateDiagram
    [*] --> Trocar_Inserted
    Trocar_Inserted --> CryoCannula_Inserted
    CryoCannula_Inserted --> Cooling_Activated: Initiate Cryogen Flow
    Cooling_Activated --> Bone_Freezing_Fracture: Localized Tissue Freezing (-60C)
    Bone_Freezing_Fracture --> Path_Generation_Advancement: Mechanical Displacement & Aspiration
    Path_Generation_Advancement --> Realtime_3D_Imaging: Robotic C-arm CT Scan
    Realtime_3D_Imaging --> AI_Path_Analysis: Compare Actual vs. Planned Path (AR Overlay)
    AI_Path_Analysis --> Dynamic_Steering_Adjustment: For Multi-Segment Cannula (Inverse Kinematics)
    Dynamic_Steering_Adjustment --> Path_Generation_Advancement
    Path_Generation_Advancement --> Curved_Path_Complete: Desired Depth and Geometry Reached
    Curved_Path_Complete --> Warming_Aspiration: Deactivate Cooling & Aspirate Residuals
    Warming_Aspiration --> Treatment_Device_Delivery
    Treatment_Device_Delivery --> [*]

3. Cross-Domain Application (Methodological Implications)

Enabling Description:

• Oil & Gas - Directional Drilling for Micro-Wells: The method involves an initial vertical micro-drill bore into a geological formation. A steerable micro-drill string (e.g., 20mm OD), equipped with a deflectable, preformed curved section (analogous to the cannula 50), is then advanced. This curved section, reinforced with high-strength alloys (e.g., Inconel) and integrating a micro-turbine drilling head (e.g., 5000-10000 RPM, diamond-impregnated cutters), is deployed to create a curved borehole (e.g., 15-20m radius of curvature) through specific geological strata (e.g., shale, sandstone). Real-time downhole sensor data (e.g., gamma ray, resistivity logs, micro-seismic sensors) and acoustic telemetry (e.g., 1-10 Hz data rate) guide the steering, enabling precise navigation to fluid-rich zones or storage reservoirs (e.g., for CO2 sequestration) with positional accuracy of <0.5 meters over hundreds of meters.

graph TD
    A[Initial Vertical Drilling (Pilot Hole)] --> B{Insert Steerable Micro-Drill String};
    B --> C{Deploy Curved Section of Drill String};
    C --> D[Advance Micro-Drill Head into Geological Formation];
    D --> E{Real-time Downhole Logging Data (Gamma, Resistivity, Seismic)};
    E --> F{Adjust Steering Parameters (e.g., Mud Motor Deflection, RPM)};
    F --> D;
    D -- Curved Borehole Created --> G[Target Reservoir Accessed/Geological Feature Mapped];

• Construction - Precision Boring for Utility Installation: The method begins with an initial surface-entry bore (e.g., 10 cm diameter) for trenchless utility installation. A flexible conduit (trocar equivalent, e.g., HDPE pipe, 8 cm OD) is then inserted into the soil. A steerable drilling head (cannula equivalent, e.g., 7 cm OD) with a preformed curved trajectory is then advanced within the conduit. The drilling head, comprising high-pressure water jets (e.g., 100-200 bar, 5-10 L/min) or a pneumatic hammer (e.g., 1000-2000 bpm), creates a curved path through various soil types (e.g., clay, sand, gravel). Ground-penetrating radar (GPR, e.g., 400 MHz antenna) and magnetic trackers (e.g., sonde with coil sensor) monitor the real-time X, Y, Z position of the drilling head with <10 cm accuracy, ensuring accurate navigation around existing utilities and obstacles (e.g., buried pipes, tree roots), reaching a target exit point for fiber optic cables or irrigation lines.

graph TD
    A[Identify Start/End Points & Subsurface Obstacles (GPR Survey)] --> B{Establish Surface Entry Bore (Initial Pit)};
    B --> C{Insert Flexible Conduit (Sleeve)};
    C --> D{Deploy Steerable Drilling Head (e.g., Hydro-jet/Pneumatic)};
    D --> E[Activate Boring Mechanism];
    E --> F{Real-time GPR/Magnetic Tracking for Position};
    F --> G{Adjust Steering for Obstacles/Target Course};
    G --> E;
    E -- Curved Path Created --> H[Reach Target Exit Point (Receiving Pit)];

• Medical - Ophthalmic Micromanipulation: The method begins with an initial micro-trocar (<0.5 mm outer diameter, 25-gauge) insertion through the sclera into the vitreous humor. A flexible micro-cannula (50 equivalent, <0.2 mm outer diameter, made of superelastic Nitinol) with an electromagnetically steerable tip (as described in CE Cross-Domain, using integrated micro-coils) is then introduced. The method involves dynamically steering this micro-cannula through the vitreous humor, bypassing critical structures like the lens and fovea (monitored via optical coherence tomography (OCT) at 10-20 frames/sec, 5-10 micron resolution), to deliver a precisely targeted drug micro-injector (e.g., 50 micron diameter tip, picoliter volume control) or a miniature laser fiber (e.g., 50 micron core diameter, 532 nm wavelength) for retinal treatment (e.g., photocoagulation). Real-time, high-resolution OCT imaging feedback guides the navigation, with a target accuracy of <10 microns at the retinal surface.

sequenceDiagram
    Surgeon->>Sclera: Insert Micro-Trocar (Initial Access)
    Sclera->>Vitreous_Humor: Access to Ocular Cavity
    Micro_Trocar->>Micro_Cannula: Insert Electromagnetically Steerable Cannula
    Micro_Cannula-->>Vitreous_Humor: Navigate via EM-Steering (Real-time OCT-Guided)
    Micro_Cannula->>Retinal_Target: Reach Specific Retinal/Choroidal Target
    Micro_Cannula->>Treatment_Tool: Deliver Drug Micro-Injector/Laser Fiber
    Treatment_Tool->>Retinal_Target: Perform Therapy/Diagnostic Sampling
    Micro_Cannula->>Micro_Trocar: Retract Cannula
    Micro_Trocar->>Sclera: Withdraw Micro-Trocar

4. Integration with Emerging Tech (Methodological Implications)

Enabling Description:

• AR/VR Guided Surgery: Prior to "inserting a trocar into a region of bone," the surgeon wears an Augmented Reality (AR) headset (e.g., Microsoft HoloLens 2 or similar medical-grade AR device). Pre-operative 3D CT/MRI data of the patient's spine, segmented and rendered with the planned curved instrument path (BVN and critical structures like spinal cord, major vessels highlighted), is spatially registered and overlaid onto the patient's body with <1 mm accuracy. During the procedure, the AR system tracks the actual position and orientation of the trocar (20) and cannula (50) using fiducial markers or optical tracking systems (e.g., Polaris optical tracker). This allows the surgeon to visualize the instrument's real-time progression relative to the planned path and anatomical structures, projected directly into their field of view. The AR system provides intuitive visual guidance (e.g., color-coded proximity warnings, trajectory vectors) for instrument insertion, rotation, and advancement, enhancing precision and minimizing off-target navigation.

graph TD
    A[Pre-op Imaging & AI Path Planning] --> B{3D Anatomical Model & Optimal Trajectory Generated};
    B --> C[AR Headset Renders Overlay on Patient Anatomy];
    C --> D{Optical Tracking System Monitors Instrument Position (Trocar/Cannula)};
    D --> E[AR System Overlays Real-time Instrument Position on 3D Model];
    E --> F{Surgeon Guides Instrument Insertion & Deployment (Visual Cues)};
    F --> G{AR System Provides Real-time Visual Feedback/Proximity Alerts};
    G --> D;
    G -- Path Completed --> H[Treatment Delivered (AR-Guided Verification)];

• Automated Robotics for Precision Deployment: A multi-axis surgical robot arm (e.g., KUKA LBR iiwa or similar, with <50 micron repeatability) is programmed to perform the entire "method for channeling a path into bone." After initial manual registration and sterile draping, the robot precisely inserts the trocar (20) based on an AI-optimized path and real-time intra-operative imaging (e.g., fluoroscopy-based 3D reconstruction). Subsequently, the robot, receiving real-time force/position feedback from integrated instrument sensors (e.g., 6-axis force/torque sensor at the robot wrist) and continuous imaging guidance (e.g., intra-operative cone-beam CT updates every 5-10 seconds), performs the automated deployment of the straightening stylet (40), curved cannula (50), curved stylet (60), and channeling stylet (90). The robot's end-effector executes precise linear advancements (e.g., 0.1 mm increments), rotations (e.g., 1-degree increments), and locking mechanisms, ensuring the curved path is generated exactly as planned and the treatment device (100) is delivered to the target with sub-millimeter accuracy (<0.5 mm).

sequenceDiagram
    Participant Surgeon
    Participant Surgical_Robot_Arm
    Participant Instrument_Set
    Participant AI_Control_System
    Participant Imaging_System_Intraop

    Surgeon->>Surgical_Robot_Arm: Initialize & Load Instrument Set (Sterile Field)
    AI_Control_System->>Surgical_Robot_Arm: Provide AI-Optimized Pre-Planned Trajectory
    Surgical_Robot_Arm->>Instrument_Set: Insert Trocar (Automated, Imaging-Guided)
    loop Path Generation & Navigation
        Instrument_Set->>AI_Control_System: Real-time Force/Position Data (Sensor Fusion)
        Imaging_System_Intraop->>AI_Control_System: Real-time Imaging Feedback (CBCT/Fluoroscopy)
        AI_Control_System->>AI_Control_System: Analyze Data & Update Path/Parameters (e.g., ML-based adaptation)
        AI_Control_System->>Surgical_Robot_Arm: Adjust Trajectory/Speed/Rotation
        Surgical_Robot_Arm->>Instrument_Set: Deploy Cannula/Stylets (Automated Execution)
    end
    Surgical_Robot_Arm->>Instrument_Set: Deliver Treatment Device (Automated to Target)
    Instrument_Set->>AI_Control_System: Confirm Treatment Delivery Parameters

• Smart Materials for Adaptive Curvature: The method incorporates a curved cannula (50) whose deflectable tip (56) is composed of a functionally graded material (FGM) or a composite with embedded magnetorheological (MR) or electrorheological (ER) fluids. As the cannula advances, integrated micro-ultrasound transducers (e.g., 20 MHz, 0.5 mm element size) or electrical impedance sensors (e.g., 10 kHz-1 MHz, micro-electrode array) at the distal tip detect local bone density in real-time. This density information is fed to a control unit, which then adjusts an external magnetic field (for MR fluid) or electric field (for ER fluid) applied to the cannula via a sleeve coil or electrode array. This field modulates the apparent viscosity and stiffness of the fluid within the cannula's wall, allowing the preformed curve to stiffen in dense bone or soften in less dense regions, thereby dynamically adapting its mechanical properties (e.g., flexural stiffness range 10-100 N/mm) to maintain the desired radius of curvature (r) and prevent deviation (maintaining <0.2 mm deviation) during path generation, regardless of heterogeneous bone properties.

classDiagram
    class CurvedCannula {
        +DeflectableTip: FGM_Composite_MR/ER_Fluid
        +Micro_Ultrasound_Transducers: Local_Bone_Density_Sensing
        +Electrical_Impedance_Sensors: Local_Bone_Density_Sensing
        +ExternalField_Actuator: Sleeve_Coil/Electrode_Array
    }
    class ControlUnit {
        +Input_Sensors: Bone_Density_Data
        +Output_Actuator: Magnetic/Electric_Field_Control_Signal
        +Algorithm: Adaptive_Stiffness_Optimization_Logic
    }
    class ExternalFieldGenerator {
        +Field_Type: Magnetic/Electric
        +Field_Strength_Control: Variable_Power_Supply
    }
    CurvedCannula "1" -- "1" ControlUnit : transmits_sensor_data_to
    ControlUnit "1" -- "1" ExternalFieldGenerator : controls_field_strength_of
    ExternalFieldGenerator "1" -- "1" CurvedCannula : applies_adaptive_field_to

5. The "Inverse" or Failure Mode (Methodological Implications)

Enabling Description: The method incorporates real-time monitoring of intraluminal pressure, bio-impedance, and acoustic emissions at the distal tip of the cannula (50) and stylets (60, 90). A multi-modal sensor array with a distal pressure sensor (e.g., MEMS piezoresistive, 0-100 kPa), a tissue impedance sensor (e.g., 1 kHz-100 kHz, 4-electrode array), and an acoustic emission transducer (e.g., 50 kHz-1 MHz bandwidth) is integrated into the tip. If a sudden drop in pressure (>5 kPa in 100 ms, indicating perforation into a cavity), a characteristic change in bio-impedance (e.g., 20% drop from bone to nerve/dura, or 50% drop to blood vessel), or a specific acoustic signature (indicating stylet fracture or bone micro-fracture) occurs unexpectedly, the system immediately triggers a "fail-safe" protocol. This protocol involves: 1) automatic cessation of all energy delivery (e.g., RF power, laser activation) within 50 ms; 2) rapid, automated retraction of the curved cannula (50) and stylets (60, 90) into the protective trocar (20) at a controlled speed (e.g., 10 mm/s) to minimize further tissue damage; and 3) audible and visual alerts (e.g., flashing red lights, loud siren) to the surgical team on the console and via AR overlay. This system is designed to minimize iatrogenic injury in critical anatomical breach scenarios or instrument integrity compromise.

stateDiagram
    [*] --> Initial_Insertion_Phase
    Initial_Insertion_Phase --> Path_Generation_Active: Trocar/Cannula/Stylet Deployment
    Path_Generation_Active --> Monitoring_Safe_Mode: (All Sensor Readings within Safe Limits)
    Monitoring_Safe_Mode --> Critical_Event_Detected: Event: (Pressure_Drop OR Impedance_Change OR Acoustic_Signature_Match OR Stylet_Fracture)
    Critical_Event_Detected --> Energy_Cessation_Protocol: Immediate Power Cutoff
    Energy_Cessation_Protocol --> Automated_Retraction_Protocol: Controlled Withdrawal into Trocar
    Automated_Retraction_Protocol --> Alerts_Engaged_Protocol: Visual & Audible Alarms
    Automated_Retraction_Protocol --> Instruments_Secured: Distal Tip Safely Within Trocar
    Alerts_Engaged_Protocol --> Surgeon_Assessment_Intervention
    Instruments_Secured --> [*]

---

Combination Prior Art Scenarios with Open-Source Standards

These scenarios illustrate how the core concepts of US Patent 12303166 could be combined with widely adopted open-source standards, thereby expanding the prior art and potentially rendering future developments in these areas obvious.

1. Integration with DICOM (Digital Imaging and Communications in Medicine) Standard for Surgical Planning and Guidance

Description: The system and method for channeling a path into bone (US12303166) are integrated with medical imaging data formatted according to the DICOM standard for comprehensive pre-operative planning and intra-operative navigation. Patient-specific anatomical data (e.g., 3D volumetric CT and MRI scans of the spine, displaying cortical and cancellous bone, basivertebral nerves, and spinal canal structures) is acquired and stored in DICOM format (e.g., DICOM-CT-SC for structured dose reports, DICOM-SR for surgical planning reports). This allows for standardized data exchange between various imaging modalities and specialized surgical planning software. An AI-powered planning module processes this DICOM data to generate an optimal, patient-specific curved trajectory for the cannula, which is then saved as a DICOM-compliant Structured Report (SR). During surgery, this DICOM SR, containing the planned path parameters (e.g., entry point, target coordinates, radius of curvature, insertion depth), is loaded directly into a DICOM-enabled surgical navigation system. This system tracks the real-time position of the trocar (20) and curved cannula (50) (e.g., using optical or electromagnetic trackers) and overlays their trajectories onto the pre-operative DICOM images, guiding the surgeon through the entire procedure with sub-millimeter accuracy. This integration ensures seamless interoperability and consistent data interpretation across diverse medical devices and software platforms within a hospital network.

2. Integration with ROS (Robot Operating System) for Robotic-Assisted Deployment

Description: The robotic-assisted deployment of the channeling system (trocar, curved cannula, stylets) described in US12303166 is controlled and managed using the open-source Robot Operating System (ROS) framework. A surgical robot manipulator (e.g., an industrial robot arm adapted for medical use) is equipped with specialized end-effectors to grasp and articulate the trocar (20), curved cannula (50), and various stylets (40, 60, 90). The robot's control architecture is built on ROS, where individual functionalities are encapsulated in ROS nodes. For instance, a kinematics_node handles inverse kinematics for precise robot arm movements, translating desired instrument tip positions into joint commands. A sensor_fusion_node processes real-time data from instrument-embedded force sensors, optical trackers (e.g., tracking fiducial markers on the instrument handles), and intra-operative imaging systems (e.g., a fluoroscopy_node). A control_loop_node implements the AI-driven path optimization algorithms, generating commands for instrument advancement, rotation, and dynamic curvature adjustment. These nodes communicate asynchronously via ROS topics, allowing for modular development of robotic control algorithms, easy integration of different sensor and actuator types, and leveraging the extensive open-source community for potential improvements in surgical robotics.

3. Integration with HL7 FHIR (Health Level Seven Fast Healthcare Interoperability Resources) for Electronic Health Record (EHR) Logging

Description: The logging of surgical parameters, instrument usage, and treatment outcomes from the method of US12303166 into a patient's Electronic Health Record (EHR) is performed using the HL7 FHIR standard. After the "method for channeling a path into bone" and "delivering a treatment device" are completed, all relevant surgical data is captured by the surgical system. This includes the unique identifiers of the specific instruments used (e.g., Device.identifier for trocar, cannula, stylets), the actual trajectory of the created bone channel (e.g., represented as ImagingStudy or Procedure.outcome references), the energy delivered by the treatment device (e.g., Observation resources detailing RF parameters like power, duration, temperature, or agent type/volume), and any immediate outcomes or complications. This data is then formatted into FHIR resources (e.g., Procedure resource for the overall surgical act, Observation resources for detailed measurements, DeviceUseStatement for instrument tracking). These FHIR resources are transmitted securely (e.g., via FHIR APIs over HTTPS) to update the patient's EHR system. This standardized interoperability ensures that granular surgical data is consistently recorded, accessible across different healthcare systems, and compliant with modern healthcare data exchange regulations, significantly facilitating post-operative analysis, clinical research, quality improvement initiatives, and auditability.