Balloon Micro-Needle Fluid Delivery for Uniform Tissue Injection

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Solution Overview

Problem

Current methods for delivering therapeutic fluids to thin tissues, such as those in the urinary tract, face challenges in achieving uniform distribution and precise delivery, often requiring specialized skills and causing discomfort due to the need for high-pressure injection and single-needle procedures.

Innovation Solution

The use of balloon-based systems with micro-needles that allow for precise and controlled delivery of therapeutic fluids, including biologically active agents, to specific anatomical locations within the urinary tract, such as the bladder, without the need for incisions, using a dual-balloon configuration to protect tissues and ensure accurate penetration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If a single needle is used for injection into thin tissue, then the procedure can be performed with simple equipment, but the distribution of therapeutic agents becomes non-uniform and delivery precision is reduced

Engineering Contradiction:
Improveinjection device structureVSAvoidfluid distribution uniformity
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The single needle is divided into multiple micro-needles arranged in an array on the balloon surface. This segmentation allows the therapeutic fluid to be delivered through multiple injection points simultaneously, achieving uniform distribution across the thin tissue while maintaining relative simplicity in the overall device structure.

Inventive Principle:
Principle #1Segmentation

2Reliability

If high-pressure injection is used to deliver fluid to thin tissue, then the fluid can penetrate the tissue effectively, but patient discomfort increases and tissue damage occurs

Engineering Contradiction:
Improvefluid delivery effectivenessVSAvoidtissue damage and patient discomfort
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

By dividing the injection function into multiple micro-needles, the system can deliver fluid at lower pressure through each individual needle while maintaining effective penetration. The collective effect of multiple needles achieves the required fluid delivery without the excessive pressure and tissue damage associated with single-needle high-pressure injection.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system changes the pressure parameter by using multiple injection points, which allows fluid delivery at reduced pressure per needle while maintaining overall delivery effectiveness. This parameter change reduces tissue damage and patient discomfort while preserving therapeutic efficacy.

Inventive Principle:
Principle #35Parameter changes

3Adaptability or versatility

If a long travel length is used in needleless injection systems, then the device can be positioned remotely, but the required pressurization level increases significantly

Engineering Contradiction:
Improvedevice positioning flexibilityVSAvoidfluid pressurization level
Core Design Contradiction:
Adaptability or versatilityVSStress or pressure

Solution Approach 1:

The injection system uses multiple micro-needles arranged on the balloon, which reduces the required pressurization level compared to a single needle at the same distance. The segmented approach allows fluid to travel through shorter effective paths and reduces friction losses, enabling remote positioning without excessive pressurization.

Inventive Principle:
Principle #1Segmentation

4Device complexity

If a rigid shaft with single distal needle is used, then the device structure is simple, but the procedure requires specialized skills and dexterity

Engineering Contradiction:
Improvedevice structureVSAvoidprocedure difficulty
Core Design Contradiction:
Device complexityVSEase of operation

Solution Approach 1:

The single distal needle is segmented into multiple micro-needles arranged in an array on the balloon surface. This segmentation automatically creates multiple injection points, eliminating the need for specialized manual injection skills while maintaining simple device structure. The micro-needle array self-aligns with the tissue, making the procedure more intuitive and easier to perform.

Inventive Principle:
Principle #1Segmentation

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

Enables precise and accurate delivery of therapeutic agents to thin tissues with minimal discomfort and procedural time, improving treatment outcomes by ensuring uniform distribution and reducing tissue damage.

Implementation Method 1

the balloon can be inflated to a desired size and/or shape. Inflation of the balloon can allow for direct contact between the balloon and the inner surface of the bladder, which in turn allows for penetration of the micro-needles into the desired tissue for injection of fluids

Methodology Applied
Scientific EffectPressure: Pressure Increase

Implementation Method 2

Inflation of the outer balloon can cause the micro-needles to pierce through the outer balloon and into adjacent tissue

Methodology Applied
Scientific EffectMechanical Force: Mechanical Force

Data Source

PatentUS11357955B2Devices, systems, and related methods for delivery of fluid to tissue
Publication Date: 2022.06.14 BOSTON SCIENTIFIC SCIMED INC
  • US11357955B2 patent drawing
  • US11357955B2 patent drawing
  • US11357955B2 patent drawing

AI summary

A fluid delivery system including a first balloon and a second balloon at least partially positioned within the first balloon, wherein the second balloon has an inner surface, an outer surface, and at least one micro-needle extending outwardly from the outer surface of the second balloon. The delivery system can further include a fluid source in communication with at least one of the micro-needles of the second balloon.