Methods And Devices For Puncturing Tissue
Patent No. US11998238 (titled "Methods And Devices For Puncturing Tissue") was filed by Boston Scientific Medical Device Ltd on Sep 14, 2021.
What is this patent about?
’238 is related to the field of medical devices, specifically those used for accessing and puncturing tissue within a patient's body. The background involves procedures where access to a target tissue site is needed, often requiring punctures. Existing methods can be inefficient, involving multiple device exchanges and difficulties in navigating tortuous vasculature to reach the desired puncture location, such as accessing the left side of the heart.
The underlying idea behind ’238 is to create a multi-functional guidewire that can both puncture tissue and serve as a rail for subsequent device delivery. This is achieved by combining a distal section with an active, energy-delivering tip for creating the puncture, a maneuverable rail section for accessing the tissue site, and a distal section with a curved portion and a straight portion having a reverse taper. The reverse taper on the distal section straight portion is key, as it increases in diameter distally.
The claims of ’238 focus on a medical device with an elongate member having a proximal section, a distal section, and a rail section. The device features an active tip at the distal end for delivering energy to puncture tissue. Crucially, the rail section is designed to both support the installation of tubular members and be maneuverable for accessing the tissue site. The distal section includes a curved portion and a straight portion with a reverse taper , where the straight portion's diameter increases distally.
In practice, the guidewire is advanced to the target tissue site, and the active tip is used to create a puncture. The distal section's curved portion helps anchor the guidewire after the puncture, while the straight portion with the reverse taper ensures a smooth transition and prevents the guidewire from immediately curling back on itself. The rail section then provides a stable platform for advancing other devices, such as catheters or leads, to the target location.
This design differentiates from prior approaches by integrating multiple functions into a single device. Traditional methods often require separate devices for puncturing, dilation, and rail support, leading to multiple exchanges and increased procedure time. The integrated design of ’238 streamlines the process, reducing the number of device exchanges and improving efficiency, particularly in complex procedures like transseptal punctures.
How does this patent fit in bigger picture?
Technical landscape at the time
In the early 2010s when ’238 was filed, medical device systems commonly relied on guidewires and sheaths for accessing tissue sites within a patient's body. At a time when accessing specific cavities often required multiple device exchanges, the curvature and tortuosity of vasculature made it non-trivial to deliver treatment tools to the desired puncture site. Fixed curve sheaths and steerable sheaths were utilized, but the stiffness of dilators and other devices inserted within them could limit their ability to reach the intended curvature or cause breakage of the actuation mechanism.
Novelty and Inventive Step
The examiner approved the application because the applicant's amendments and arguments distinguished the claims from the prior art. Specifically, the examiner agreed that there was no clear motivation to provide the Stewart guidewire with a "waist" portion as taught by Chanduszko. Additionally, the applicant's terminal disclaimer addressed the double patenting rejection.
Claims
This patent contains 17 claims, with claim 1 being the only independent claim. Independent claim 1 is directed to a medical device for puncturing tissue, featuring an elongate member with a rail section and an active tip. The dependent claims generally elaborate on specific configurations and features of the medical device described in the independent claim, such as the shape of the distal section, the composition of the elongate member, and the characteristics of the active tip.
Key Claim Terms New
Definitions of key terms used in the patent claims.
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Date
Description
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US11998238
- Application Number
- US17474415
- Filing Date
- Sep 14, 2021
- Status
- Granted
- Expiry Date
- Sep 13, 2034
- External Links
- Slate, USPTO, Google Patents