Image-Guided Percutaneous Needle Navigation for Renal Neuromodulation
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Solution Overview
Problem
Existing pharmacologic strategies for managing chronic renal sympathetic stimulation, such as hypertension and heart failure, have limitations including limited efficacy, compliance issues, and side effects, necessitating the development of alternative methods for renal neuromodulation.
Innovation Solution
A percutaneous medical device navigation system comprising an adhesive patch with tracking markers, a guide assembly, and a navigation device to accurately guide a needle to renal sympathetic nerves for chemical ablation, allowing direct access from the skin surface without catheterization, enabling repeated treatments without redundant imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If pharmacologic strategies are used to manage renal sympathetic stimulation, then treatment coverage is provided, but efficacy is limited and side effects occur
Solution Approach 1:
The patent replaces pharmacologic (chemical) treatment with a percutaneous mechanical intervention. A needle is inserted through the skin to deliver therapeutic agents or perform ablation directly at the renal sympathetic nerve target site, substituting systemic drug administration with localized mechanical delivery to improve efficacy and reduce side effects.
Solution Approach 2:
The patent introduces a percutaneous needle as an intermediary device to deliver therapeutic agents or energy directly to the renal sympathetic nerves. This intermediary approach allows precise targeting of the pathology while avoiding the systemic effects of pharmacologic strategies.
2Ease of operation
If percutaneous needle insertion is used for renal neuromodulation, then direct access to treatment site is achieved, but precise navigation to target is challenging
Solution Approach 1:
The patent employs imaging guidance (such as ultrasound, fluoroscopy, or CT) to provide real-time feedback on needle position during percutaneous insertion. This feedback mechanism allows the operator to visualize the needle's trajectory and adjust positioning to ensure accurate targeting of the renal sympathetic nerves.
Solution Approach 2:
The patent replaces blind mechanical needle insertion with image-guided navigation. By substituting unguided mechanical placement with radiologically or ultrasonically guided positioning, the system achieves both the ease of percutaneous access and the precision of image-guided targeting.
3Duration of action of moving object
If repeated catheterization and imaging are performed for renal neuromodulation, then treatment can be repeated, but patient burden and cost increase
Solution Approach 1:
The patent performs preliminary anatomical mapping and target identification during the initial procedure using imaging guidance. This preliminary action creates a roadmap that facilitates subsequent repeat treatments without requiring redundant extensive imaging, thereby reducing patient burden while maintaining repeatability.
Solution Approach 2:
The patent creates a virtual or physical model of the anatomical landmarks and target site during the initial procedure. This copy or template can be used to guide subsequent treatments, eliminating the need for repeated comprehensive imaging and reducing overall treatment time and patient burden.
Data Source
AI summary
A medical device navigation system includes a medical device assembly and a navigation device. The medical device assembly includes an adhesive patch configured to adhere to an outer surface of a patient and a tracking assembly coupled to the adhesive patch. The tracking assembly includes one or more reference markers. The navigation device is configured to receive image data representing one or more images from an imaging device. The one or more images indicate a relative position between the one or more reference markers and a treatment site in the patient. The navigation device is configured to determine, based on the image data, a percutaneous insertion path for an injection needle from an insertion point to the treatment site of the patient and output one or more parameters corresponding to the percutaneous insertion path.