Methods, Systems, And Apparatuses For Perforating Tissue Structures
Patent No. US12343074 (titled "Methods, Systems, And Apparatuses For Perforating Tissue Structures") was filed by Atraverse Medical Inc on Feb 16, 2024.
What is this patent about?
’074 is related to the field of medical devices, specifically electrosurgical systems used for tissue perforation, particularly in cardiac interventions like transseptal puncture. The background involves the need to create passageways through tissue structures to access treatment sites, such as puncturing the atrial septum to reach the left side of the heart. Existing systems have drawbacks like unwanted injury, char formation, complicated connections, and high manufacturing costs.
The underlying idea behind ’074 is to improve the safety and efficiency of tissue perforation by using a guidewire with a variable current density profile . This is achieved by strategically placing an insulating collar near the distal tip and exposing a conductive outer region as the guidewire extends beyond an insulating sheath. The initial high current density at the tip facilitates tissue puncture, while the subsequent reduction in current density minimizes the risk of unintended tissue damage.
The claims of ’074 focus on a method of using a guidewire with an insulating sheath. The method involves extending the guidewire's distal tip a first distance to contact a septum, delivering RF energy to perforate the septum, and then further extending the tip a second distance. This second extension exposes both an insulating collar and a conductive outer region, which reduces the RF current density around the tip.
In practice, the guidewire is advanced through a patient's vasculature within an insulating sheath until it reaches the target tissue, such as the atrial septum. The guidewire is then extended a short distance to expose the distal tip, which delivers concentrated RF energy to create a puncture. As the guidewire is advanced further, the insulating collar and conductive outer region are exposed, effectively increasing the conductive surface area and reducing the current density at the tip. This prevents excessive heating and potential damage to surrounding tissues after the initial puncture.
This design differentiates from prior approaches by actively managing the current density profile during the procedure. Traditional electrosurgical devices often maintain a constant current density, which can lead to unintended tissue damage after the initial puncture. By strategically exposing a conductive outer region and using an insulating collar, ’074 provides a self-regulating mechanism that enhances safety and control during tissue perforation. The insulating collar ensures that the current density at the distal tip remains high enough to penetrate the septum, while the conductive outer region reduces the current density to prevent lesions in the heart wall.
How does this patent fit in bigger picture?
Technical landscape at the time
In the early 2020s when ’074 was filed, medical devices commonly relied on radiofrequency (RF) energy delivery for tissue perforation during procedures such as transseptal puncture. At a time when such systems were typically implemented using guidewires and catheters, a key engineering constraint was preventing unwanted injury to other areas of the heart from inadvertent perforation or lead to char or thrombus formation due to high operating temperatures.
Novelty and Inventive Step
The examiner approved the claims because the prior art, whether considered individually or in combination, did not disclose or make obvious a method involving a guidewire with a distal tip, a conductive outer region, and an insulating collar within an insulating sheath. Specifically, the prior art failed to teach a guidewire including a conductive outer region and an insulating collar disposed between the distal tip and the conductive outer region in combination with the other limitations.
Claims
This patent contains 19 claims, with claim 1 being the only independent claim. Independent claim 1 is directed to a method of using a guidewire with an insulating sheath to create a perforation in the septum of a heart using radiofrequency energy. The dependent claims generally elaborate on and refine the method of independent claim 1, adding details regarding tenting the septum, dilating the perforation, using a surgical instrument, electrosurgical interface, monitoring and modulating RF energy, and specific characteristics of the insulating collar and conductive outer region.
Key Claim Terms New
Definitions of key terms used in the patent claims.
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Date
Description
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US12343074
- Application Number
- US18444623
- Filing Date
- Feb 16, 2024
- Status
- Granted
- Expiry Date
- Dec 27, 2043
- External Links
- Slate, USPTO, Google Patents