Inflatable Implant for Precise Occlusion

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Solution Overview

Problem

Current occluding devices for vascular and anatomical issues, such as embolization, face challenges with precision placement, biocompatibility, and removal difficulties due to biodegradable materials and organic solvents causing tissue damage, and inexact placement of precipitating polymers.

Innovation Solution

An inflatable, expandable implant with a non-elastic or elastic bladder wall that can be filled with various materials to occlude or support body regions, allowing for precise placement and potential removal, using materials that do not introduce harmful solvents and can be designed for controlled expansion and deflation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of repair

If biodegradable materials are used for occlusion, then removal is facilitated, but tissue damage occurs due to toxic degradation products

Engineering Contradiction:
Improveremoval easeVSAvoidtissue damage
Core Design Contradiction:
Ease of repairVSObject-affected harmful factors

Solution Approach 1:

The patent applies this principle by using non-biodegradable materials that are inert and non-toxic, converting the potential harm of material degradation into a benefit by selecting materials that do not degrade but also do not harm surrounding tissues. The materials remain stable indefinitely without releasing toxic substances.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

Solution Approach 2:

The patent employs this principle by selecting occlusion materials that are biologically inert, creating an environment where the implant does not interact chemically with surrounding tissues. This inertness prevents both degradation and toxic reactions, allowing safe long-term presence in the body.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

2Ease of operation

If liquid embolic materials are used, then ease of delivery is improved, but inexact placement occurs due to premature polymerization

Engineering Contradiction:
Improvedelivery easeVSAvoidplacement precision
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The patent applies this principle by pre-mixing the liquid embolic components in a stable state that prevents premature polymerization during delivery. The materials are prepared in advance with controlled stability, allowing them to remain fluid during injection but polymerize only after reaching the target site.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent employs feedback mechanisms through controlled polymerization triggers that respond to specific conditions at the target site. The materials remain in liquid form during delivery and only polymerize when exposed to the intended environment, providing real-time control over the occlusion process.

Inventive Principle:
Principle #23Feedback

3Reliability

If microcoils are used for occlusion, then occlusion effectiveness is improved, but removal difficulty increases and skill requirement increases

Engineering Contradiction:
Improveocclusion effectivenessVSAvoidremoval ease
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent applies this principle by changing the physical state and chemical properties of the occlusion material from rigid metal coils to flexible liquid polymers. This parameter change allows the material to be delivered in a fluid state, then transform into a solid occlusion, fundamentally altering both delivery and removal characteristics.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent employs composite materials by combining liquid polymer precursors that can be delivered together and then polymerize to form a cohesive occlusion mass. This composite approach allows for unified delivery and controlled transformation, simplifying both placement and potential removal compared to mechanical coil structures.

Inventive Principle:
Principle #40Composite materials

4Adaptability or versatility

If the implant is made expandable, then adaptability to different body regions is improved, but device complexity increases

Engineering Contradiction:
ImproveadaptabilityVSAvoiddevice complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent applies this principle by designing the implant with dynamic expandability, allowing it to transition from a compressed delivery state to an expanded functional state. This dynamic capability enables the same device to adapt to various body regions and sizes without requiring multiple specialized implants.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent employs flexible membranes and thin-walled structures that can be compressed for delivery through catheters and then expanded at the target site. These flexible components provide the necessary adaptability while maintaining structural integrity, achieving versatility without excessive complexity.

Inventive Principle:
Principle #30Flexible shells and thin films

Data Source

PatentUS7632291B2Inflatable implant
Publication Date: 2009.12.15 BOSTON SCIENTIFIC CORPORATION
  • US7632291B2 patent drawing
  • US7632291B2 patent drawing
  • US7632291B2 patent drawing

AI summary

Described is an inflatable implant suitable for placement in the human body and left there for an indeterminate and potentially lengthy period of time. The implant is one that has a low profile when introduced into the body and a larger profile when it is inflated with one or more filler materials. Depending upon design and use choices the delivered implant may be removable and adjustable in situ in size, position, location, form, and rigidity. Indeed, in some variations, the design of the implant may be such that it may be removed at a potentially fairly lengthy time after implantation. The implant includes at least one bladder wall that generally is at least partially non-elastic (or unexpandable) after the preselected size is reached. The bladder wall will define at least one fillable volume and may form more than one independent fillable volumes. The bladder wall, in some variations, may be partially elastic or expandable to permit adjustment of implant size or configuration after or during delivery. The implant may be used as a supporting structure in a variety of differing body tissues and structures, e.g., in the spine or as a prosthetic in plastic surgery. The implant may also be used in conjunction with other components (often having a springed bias) as a source of movement in controlling the opening of a lumen or duct, that is to say, as a type of on-off valve or as a controlled flow valve. The implant may be used as an occludant within, or adjacent to, a variety of natural or abnormal anatomical body openings, e.g., vascular and genital lumina, aneurysms, ducts, septal defects, fistulae, esophagus, etc. The wall and filler material may be selected to deliver treatment materials the locale of the implant site or to remove amounts of harmful materials from such a region. The implant may, with an appropriate filler material or bladder wall material, be used in cooperation with an appropriate radio frequency (RF) source to cause the increase of a localized internal temperature and a resulting tissue change such as coagulation, ablation, or the like. Methods of using the implant are also described.