Micro-Needle Bladder Balloon for Direct Tissue Drug Delivery

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Solution Overview

Problem

Current treatments for urinary tract disorders such as overactive bladder lack effective alternatives to medication, diet modification, and surgery, necessitating a need for innovative delivery methods for treatment fluids or particulates like stem cells and drugs directly to bladder tissue.

Innovation Solution

A balloon delivery system with micro-needles that pierce the bladder wall to inject treatment fluids, using bioabsorbable or bioresorbable materials, or a lead structure with deployable needles, to deliver stem cells, drugs, or particulates like Botox directly into bladder tissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If current treatments (medication, diet modification, surgery) are used for urinary tract disorders, then treatment options are limited, but patient quality of life is compromised due to lack of effective alternatives

Engineering Contradiction:
Improvetreatment optionsVSAvoidpatient quality of life
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The invention segments the treatment approach by dividing the bladder wall treatment into multiple discrete micro-needle injection sites, allowing targeted delivery of treatment fluids to specific regions of the bladder tissue, thereby expanding treatment versatility while maintaining patient comfort

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The balloon acts as an intermediary device that facilitates the delivery of treatment fluids through micro-needles into the bladder wall, providing a non-invasive platform that expands treatment options without requiring open surgery, thus improving patient quality of life

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If treatment fluids are delivered directly to bladder tissue, then treatment efficacy is enhanced, but delivery control and precision are challenged

Engineering Contradiction:
Improvetreatment efficacyVSAvoiddelivery control
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The balloon is pre-configured with micro-needles on its surface before insertion, allowing the treatment fluid delivery pathways to be established in advance. When the balloon is inflated against the bladder wall, the micro-needles are already positioned to penetrate the tissue, ensuring precise and controlled delivery of treatment fluids directly to the target tissue

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention replaces complex surgical mechanical systems with a simpler balloon inflation mechanism. The micro-needles are passively deployed through balloon expansion rather than active mechanical deployment, providing reliable treatment efficacy while simplifying the control mechanism and improving delivery precision

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Productivity

If micro-needles are used to pierce bladder wall, then treatment fluid delivery is improved, but tissue invasiveness and potential damage increase

Engineering Contradiction:
Improvetreatment fluid deliveryVSAvoidtissue invasiveness
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The balloon serves as a flexible shell that distributes the invasive action of micro-needles across a larger surface area. The flexible nature of the balloon allows it to conform to the bladder wall, spreading out the tissue disruption caused by multiple micro-needle penetrations, thereby improving treatment fluid delivery while reducing localized tissue damage and overall invasiveness

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The balloon surface incorporates micro-needles that create controlled porous pathways through the bladder wall. These micro-pores allow treatment fluids to pass through while being minimally invasive compared to traditional surgical approaches. The porous structure enables efficient fluid delivery without requiring large incisions or extensive tissue disruption

Inventive Principle:
Principle #31Porous materials

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

Facilitates direct and controlled delivery of treatment fluids or particulates into bladder tissue, enhancing treatment efficacy by ensuring complete delivery and minimizing invasiveness.

Implementation Method 1

an inflation balloon including micro-needles configured to pierce and otherwise puncture the inner bladder walls so as to deliver the treatment fluid to bladder tissue

Methodology Applied
Scientific EffectMechanical penetration: Mechanical Force

Implementation Method 2

the micro needles can be formed of a bioabsorbable or bioresorbable material wherein the micro needles include barbs such the micro needles break off and remain embedded within the bladder tissue upon deflation of the inflation balloon

Methodology Applied
Scientific EffectBioabsorption: Decomposition (biological)

Data Source

PatentUS12539402B2Micro-needle bladder balloon
Publication Date: 2026.02.03 BOSTON SCIENTIFIC SCIMED INC
  • US12539402B2 patent drawing
  • US12539402B2 patent drawing
  • US12539402B2 patent drawing

AI summary

Devices and methods for delivering treatment fluids or particulates such as, stem cells, drugs, Botox and like, to an inner lining of a bladder for treatment of urinary tract disorders, including over-active bladder. A balloon delivery system can include an inflation balloon having a plurality of micro-needles configured to pierce and otherwise puncture an inner bladder wall so as to deliver the treatment fluid to bladder tissue. The treatment fluid can be directly injected into the bladder tissue using the micro needles. Alternatively, the micro needles can be fabricated of bioabsorbable or bioresorbable materials such that the micro needles can remain embedded within the bladder tissue to deliver the treatment fluid or particulate.