Bioabsorbable GI Bypass Stent for Post-Gastrectomy Leak Isolation

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Solution Overview

Problem

Existing bariatric surgeries, such as sleeve gastrectomy, are prone to post-surgical leaks, particularly in the upper part of the newly-formed stomach, which are difficult to treat due to their location and can lead to complications like sepsis and require costly treatments, and existing esophageal stents are prone to migration.

Innovation Solution

A bioabsorbable gastrointestinal bypass device with a stent structure and bioadhesive coating that diverts ingested food and liquids away from the leak site, using self-expanding anchors to secure the device and prevent migration, and includes a membrane sleeve for fluid communication between the proximal and distal ends.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing esophageal stents are used to treat leaks after sleeve gastrectomy, then leak treatment function is provided, but device migration occurs due to inadequate adaptation to modified stomach geometry

Engineering Contradiction:

Improveleak treatment functionVSAvoiddevice position stability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The stent incorporates anchoring features at specific locations (proximal and distal ends) that provide enhanced grip or attachment to the gastric wall, while the intermediate portions maintain flexibility to conform to the modified stomach geometry. This localized differentiation of properties ensures both stability and adaptability.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The stent is designed with flexible intermediate portions that can dynamically adapt to the curved and modified geometry of the post-surgical stomach, while the anchoring features at the ends provide static stabilization. This dynamic flexibility allows the device to maintain its therapeutic function without migration.

Inventive Principle:

Principle #15Dynamics

2Length of moving object

If two esophageal stents are employed to treat leaks, then adequate coverage length is achieved, but device complexity and treatment invasiveness increase

Engineering Contradiction:

Improvestent coverage lengthVSAvoidnumber of stents required

Core Design Contradiction:

Length of moving objectVSDevice complexity

Solution Approach 1:

The invention combines multiple functions into a single stent device: it provides extended coverage length equivalent to two separate stents, incorporates anchoring features for enhanced stability, and maintains flexibility for anatomical adaptation. This unified design eliminates the need for multiple separate stent implantations, reducing procedural complexity and invasiveness.

Inventive Principle:

Principle #5Merging (Combining)

3Strength

If non-bioabsorbable stents are used for leak treatment, then structural integrity is maintained, but long-term tissue damage and need for additional surgery occur

Engineering Contradiction:

Improvestent structural integrityVSAvoidtissue damage from foreign body

Core Design Contradiction:

StrengthVSObject-affected harmful factors

Solution Approach 1:

The stent is constructed from bioabsorbable materials that undergo controlled degradation over time. The material properties are engineered to provide sufficient structural integrity and mechanical strength during the critical healing period (typically 4-12 weeks), after which the stent gradually loses strength and is completely absorbed by the body, eliminating long-term foreign body presence and associated tissue damage.

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The bioabsorbable stent functions as a temporary, single-use device that fulfills its therapeutic purpose during the acute healing phase and then naturally degrades and is eliminated by the body. This eliminates the need for long-term retention or surgical removal, reducing cumulative tissue trauma and healthcare costs.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

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

The device effectively isolates the leak site, allowing it to heal naturally by preventing ingested materials from reaching the leak, reducing the risk of infection and complications, and can be absorbed or removed without additional surgery.

Implementation Method 1

a coating disposed over an outer surface of the stent, wherein the coating may be impermeable to liquid

Methodology Applied

Scientific EffectImpermeability:

Implementation Method 2

The coating may include a bioadhesive

Methodology Applied

Scientific EffectAdhesion: Adhesive

Implementation Method 3

An outer surface of the elongate member may include one or more anchoring features configured to pierce or grab tissue

Methodology Applied

Scientific EffectMechanical anchoring: Mechanical Fastener

Implementation Method 4

at least a portion of the bypass device may be bioabsorbable

Methodology Applied

Scientific EffectBioabsorption: Decomposition (biological)

Data Source

PatentUS12616594B2Gastrointestinal bypass devices and related methods of use

Publication Date: 2026.05.05 BOSTON SCIENTIFIC SCIMED INC

AI summary

A bypass device may include an elongate member extending from a proximal end toward a distal end, and a proximal opening and a distal opening coupled to one another by a lumen disposed through the elongate member. The bypass device also may include at least one port extending through a side surface of the elongate tubular member, wherein at least a portion of the bypass device may be bioabsorbable.