Enhanced Low-Profile Occlusion Balloon Catheter System with Integrated Perfusion Lumen

Publication ID: 24-11857737_0001_PTD

Published: October 28, 2025

Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Low-Profile Occlusion Balloon Catheter System with Integrated Perfusion Lumen,” Published Technical Disclosure No. 24-11857737_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857737_0001_PTD

This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,737.

Summary of the Inventive Concept

The present inventive concept pertains to an improved low-profile occlusion balloon catheter system with an integrated perfusion lumen, enabling controlled occlusion and perfusion during vascular procedures while mitigating ischemia and hypertension risks.

Background and Problem Solved

The original patent disclosed a system and method for low-profile occlusion balloon catheter, which had limitations in maintaining blood flow during occlusion procedures, potentially leading to ischemia and hypertension. The new inventive concept addresses these limitations by integrating a perfusion lumen into the catheter system, ensuring continuous blood flow and reducing the risk of complications.

Detailed Description of the Inventive Concept

The enhanced low-profile occlusion balloon catheter system comprises a proximal hub with an integrated flow valve, a distal catheter section with an occlusion balloon, and an integrated perfusion lumen. The perfusion lumen is configured to maintain blood flow during occlusion procedures, reducing the risk of ischemia. The flow valve selectively fluidly communicates the proximal hub with an inflation device and the perfusion lumen, allowing for controlled occlusion and perfusion. The system can be used for vascular pre-conditioning, reducing the risk of hypertension during and after occlusion procedures.

Novelty and Inventive Step

The new claims introduce the integration of a perfusion lumen into the catheter system, which is a non-obvious improvement over the original patent. This innovation enables continuous blood flow during occlusion procedures, addressing a critical limitation of the original design.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept may include variations in the perfusion lumen's design, such as different diameters, materials, or shapes. Additionally, the system could be adapted for use in other medical procedures, such as cardiac or neurovascular interventions.

Potential Commercial Applications and Market

The enhanced low-profile occlusion balloon catheter system has significant commercial potential in the vascular intervention market, where it can be used to reduce complications and improve patient outcomes. The system may also have applications in other medical fields, such as cardiology and neurology.

CPC Classifications

Section	Class	Group
A	A61	A61M25/0068
A	A61	A61B17/12036
A	A61	A61M25/008
A	A61	A61M25/0074
A	A61	A61M25/1002
A	A61	A61M25/104
A	A61	A61M25/1006
A	A61	A61M25/10182
A	A61	A61B17/12045
A	A61	A61B17/12109
A	A61	A61B2017/00017
A	A61	A61M25/007
A	A61	A61M2025/0002
A	A61	A61M2025/1052
A	A61	A61M2025/1059
A	A61	A61M2025/1081
A	A61	A61M2025/1084
A	A61	A61M2025/1086
A	A61	A61M2025/1093

Section 103 Obviousness Analysis (PHOSITA)

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Field of Art

Interventional medical device design, specifically vascular catheter systems with occlusion and perfusion capabilities, requiring expertise in biomedical engineering, medical device design, and interventional cardiology/radiology techniques

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or medical device designer with advanced degree, 3-5 years experience in catheter design, familiar with vascular intervention techniques, material science, and fluid dynamics in medical device applications

Obviousness Rationale

A PHOSITA would recognize that integrating a perfusion lumen into an existing occlusion balloon catheter design represents a predictable engineering solution to address known limitations in vascular intervention procedures. The source patent's detailed occlusion balloon design provides a clear technical foundation for incorporating additional functional elements like a perfusion lumen. The modification represents a straightforward application of known techniques to improve medical device functionality and patient outcomes.

Obvious Combinations & Variations

Source Patent Element

Asymmetrical occlusion balloon with conical and spherical portions

PTD Variation

Adding integrated perfusion lumen alongside existing balloon geometry

Obviousness Reasoning

Known medical device design principle of incorporating additional lumens without fundamentally altering core device structure, representing a predictable design optimization

Source Patent Element

Flow valve for selective fluid communication

PTD Variation

Expanding valve functionality to control both inflation device and perfusion lumen

Obviousness Reasoning

Routine engineering modification extending existing valve control mechanism to manage multiple fluid pathways, representing a known technique for improving device versatility

Source Patent Element

Vascular occlusion procedure method

PTD Variation

Introducing real-time perfusion flow rate monitoring and control

Obviousness Reasoning

Predictable application of contemporary medical device control systems to enhance procedural precision and patient safety

Source Patent Element

Low-profile catheter design focused on minimizing vascular disruption

PTD Variation

Integrating perfusion lumen while maintaining minimal catheter profile

Obviousness Reasoning

Routine engineering optimization balancing additional functionality with existing design constraints, representing a finite set of predictable design solutions

Source Patent Element

Occlusion balloon for managing vascular procedures

PTD Variation

Adding explicit hypertension and ischemia mitigation capabilities

Obviousness Reasoning

Known medical design approach of addressing physiological complications through integrated device features, representing a logical extension of existing therapeutic techniques

35 U.S.C. § 103 Summary: Based on US Patent 11857737's comprehensive disclosure of occlusion balloon catheter systems, the present publication demonstrates that a person having ordinary skill in the art would find the integration of a perfusion lumen and associated control mechanisms an obvious variation, rendering potential claims to such a device obvious and unpatentable under 35 U.S.C. § 103, as the modifications represent predictable engineering solutions within the established technological framework of interventional medical device design.

Original Patent Information

Patent Number	US 11,857,737
Title	System and method for low-profile occlusion balloon catheter
Assignee(s)	PRYTIME MEDICAL DEVICES, INC.