Implantable medical device constraint and deployment apparatus
Inventors
Irwin, Criag W. • Silverman, James D.
Assignees
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Publication Number
US-12310871-B2
Publication Date
2025-05-27
Expiration Date
Abstract
An implantable medical device deployment system is disclosed that employs both a sheath element and a constraint member to protect implantable medical devices during delivery in a body while providing simple, accurate, and reliable device deployment. The delivery system is configured so that loading and deployment forces are not directly related to device diameter, length, or design, thus allowing a more universal delivery system across various delivered device configurations and product lines. The deployment system can provide numerous benefits, include better protection for drug-coated implantable devices.
Core Innovation
The invention describes an implantable medical device deployment system that uses a first sheath and a second sheath. Each sheath is non-proportionally actuated by the application of tension to tensile members connected to each sheath, and during deployment by the application of a single input force, the input force is variably distributed between the tensile members rather than through a proportional linkage.
A key challenge addressed is the simultaneous removal of the sheath and a constraining member. The system uses differential mechanisms to automatically modulate withdrawal rates of multiple deployment lines while receiving a single clinician input force, including pulley-based arrangements, fixed-ratio pulleys, passive slack, clutch-driven mechanisms, and differential gear/planetary arrangements.
The sheaths also provide protective and structural functions for drug-coated or other bioactive devices. An everted traction-tube sheath element provides traction and augmented axial strength, isolates and safeguards coatings from abrasion or premature release, and can contain delivery lines to reduce bow-stringing.
The document further describes a multi-step transfer/compaction approach to intermediate diameters using a transfer funnel and a second, smaller everted sheath/tube to enable thinner final delivery dimensions.
Claims Coverage
The provided independent claims are clm-00001 and clm-00013, and both share the core structure of two non-proportionally actuated sheaths with a single input force variably distributed between tensile members. Across dependent claim sets, the document adds inventive features that specify mechanisms for variably distributing the input force and additional deployment-related functions for medical devices and coatings.
Two non-proportionally actuated sheaths with variably distributed single input force
A first sheath and a second sheath, wherein each of said first and second sheaths is non-proportionally actuated by the application of tension to tensile members connected to each of the first and second sheaths, wherein on deployment by the application of a single input force, said input force is variably distributed between said tensile members.
Pulley-based variable distribution of input force between tensile members
The deployment system variably distributes an input force between tensile members using a pulley.
Differential element variable distribution of input force between tensile members
The deployment system includes a differential element that variably distributes an input force between tensile members.
Clutch mechanism variable distribution of input force between tensile members
The deployment system is configured to variably distribute an input force between tensile members using a clutch mechanism.
Multi-pulley planetary winding of deployment lines to actuate a medical device
The deployment system further includes two or more pulleys with a rotating planetary rolling element that wind deployment lines to actuate a medical device.
Both independent claims center on non-proportionally actuated first and second sheaths controlled by variably distributing a single input force between tensile members. The dependent claim material further narrows the variable distribution implementation to pulley, differential element, clutch mechanism, and a multi-pulley planetary winding arrangement that winds deployment lines to actuate the medical device.
Stated Advantages
More predictable, smoother deployment.
Reduce delivery profile effects, including necking and bow-stringing.
Safeguard drug or other bioactive coatings from abrasion or premature release.
Provide traction and augmented axial strength to protect a medical device during delivery.
Documented Applications
Deployment of implantable medical devices including stents and stent-grafts, including deployment of drug-coated or other bioactive devices.
Protecting and deploying medical devices with coatings during manufacturing/loading and delivery using a traction/axial-strength sheath and a constraining member.
A multi-step transfer/compaction to intermediate diameters using a transfer funnel and a second, smaller everted sheath/tube for thinner final delivery dimensions.
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