Balloon Access Closure Device for Vessel Puncture Hemostasis

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Solution Overview

Problem

Existing methods for achieving hemostasis after vascular procedures, such as manual compression, are time-consuming, uncomfortable for patients, and risk complications like ischemia, thrombosis, and pseudo-aneurysm formation. Additionally, internal hemostasis devices face challenges in accurate positioning and potential embolization risks.

Innovation Solution

The use of an access closure device that delivers a compliant or semi-compliant balloon into a body lumen to provide immediate hemostasis at a vessel puncture site. The balloon, made from biocompatible materials, can be left in the body lumen and cooperates with sealants and sutures to accelerate the hemostasis process without the need to deflate and withdraw the balloon through the access track.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If manual compression is used to achieve hemostasis, then hemostasis can be achieved, but the procedure is time-consuming and requires prolonged patient recumbency

Engineering Contradiction:

Improvehemostasis achievementVSAvoidcompression time and patient recumbency time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The closure device is deployed into the vascular lumen before the introducer sheath is removed, establishing hemostasis in advance. The device includes an expandable component that is positioned within the vessel and expanded to seal the puncture site, preventing blood leakage before manual compression begins. This preliminary action eliminates the need for prolonged manual compression and patient recumbency.

Inventive Principle:

Principle #10Preliminary action

2Reliability

If manual compression is applied to stop bleeding, then hemostasis is achieved, but patient discomfort increases and analgesics are frequently required

Engineering Contradiction:

Improvehemostasis achievementVSAvoidpatient discomfort and analgesic requirement

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The mechanical compression system is replaced with a device-based sealing system. The closure device includes an expandable component that mechanically seals the puncture site from within the vessel, and a sealant component that is delivered into the access track to seal the tissue tract. This substitution eliminates the need for external manual compression, thereby reducing patient discomfort and analgesic requirements.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Reliability

If excessive pressure is applied during manual compression to ensure hemostasis, then bleeding is stopped, but ischemia and thrombosis risks increase

Engineering Contradiction:

Improvehemostasis achievementVSAvoidischemia and thrombosis

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The sealing action is localized to the puncture site and access track rather than applying diffuse pressure to the entire vessel. The closure device includes an expandable component positioned specifically at the puncture site and a sealant delivered into the access track, creating localized sealing without compromising overall blood flow through the vessel. This localized approach prevents ischemia and thrombosis while achieving hemostasis.

Inventive Principle:

Principle #3Local quality

4Reliability

If internal hemostasis devices are used to seal the access track, then hemostasis can be achieved, but positioning accuracy becomes difficult and embolization risk increases

Engineering Contradiction:

Improvehemostasis achievementVSAvoidpositioning accuracy

Core Design Contradiction:

ReliabilityVSManufacturing precision

Solution Approach 1:

The closure device is delivered through the introducer sheath in a nested configuration, with the expandable component and sealant delivery system contained within the sheath. The device is positioned using the sheath as a guide, ensuring accurate placement at the puncture site. The expandable component is then deployed from within the sheath, and the sealant is delivered into the access track, eliminating positioning difficulties and embolization risks associated with separate internal hemostasis devices.

Inventive Principle:

Principle #7Nested doll (Nesting)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach significantly reduces the time required for hemostasis, minimizes patient discomfort, and lowers the risk of complications by providing effective and immediate sealing of the access track, allowing for fewer and simpler procedural steps.

Implementation Method 1

delivery of a compliant or semi-compliant balloon in a body lumen proximate an access track formed by the insertion of a device

Methodology Applied

Scientific EffectElastic expansion: Elasticity

Implementation Method 2

The balloon, made from biocompatible materials, can be left in the body lumen and cooperates with sealants and sutures to accelerate the hemostasis process

Methodology Applied

Scientific EffectAdhesion: Adhesive

Data Source

PatentUS12337133B2Access closure device

Publication Date: 2025.06.24 ABBOTT CARDIOVASCULAR SYSTEMS INC

AI summary

An access closure device for closing an opening in tissue is provided. The access closure device may comprise a balloon delivery system and a sealant delivery system. The balloon delivery system may comprise a suture, a delivery shaft, an inflatable balloon, and a balloon segment releasably attached to the delivery shaft. The sealant delivery system may comprise a sealant delivery shaft, an ejection tube, and a snare wire configured to snare a suture of the delivery system.