Balloon Drug Delivery Coating with Encapsulated Particles

Solution Overview

Problem

There is a need for medical device technology that can rapidly, efficiently, and safely transfer a drug delivery formulation from a percutaneous medical device coating onto or into a specific site in the body.

Innovation Solution

A medical device comprising a balloon with a coating of pharmaceutical agent particles encapsulated in a polymer material, where at least 50% of the pharmaceutical agent's surface area is encapsulated, and the polymer layer has a controlled thickness and crystallinity, allowing for controlled release of the agent upon inflation of the balloon.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If the pharmaceutical agent is coated on the balloon surface, then the drug delivery formulation can be transferred to the target site, but the release control and safety may be compromised

Engineering Contradiction:

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The pharmaceutical agent is divided into discrete particles, each individually encapsulated in a polymer shell. This segmentation allows each particle to function as an independent delivery unit with controlled release properties, resolving the contradiction between delivery efficiency and safety control.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The pharmaceutical agent particles are nested within polymer encapsulation shells, creating a hierarchical structure where the active ingredient is contained within a protective and controllable matrix. This nested configuration enables both efficient transfer and controlled release.

Inventive Principle:

Principle #7Nested doll (Nesting)

2Reliability

If the polymer encapsulation thickness is increased to improve controlled release, then the drug delivery safety is enhanced, but the particle size and coating complexity increase

Engineering Contradiction:

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The polymer encapsulation thickness is controlled within a specific range (2-20 microns) to optimize the balance between controlled release performance and structural simplicity. This parameter optimization allows effective drug delivery without excessive complexity.

Inventive Principle:

Principle #35Parameter changes

3Reliability

If the pharmaceutical agent particles are individually encapsulated, then the controlled release is improved, but the manufacturing precision and production difficulty increase

Engineering Contradiction:

Core Design Contradiction:

ReliabilityVSManufacturing precision

Solution Approach 1:

The encapsulation process is designed to be self-assembling, where polymer material automatically forms shells around pharmaceutical agent particles through mechanisms such as spray-drying or coacervation. This self-service approach reduces the need for complex external control systems while achieving consistent encapsulation.

Inventive Principle:

Principle #25Self-service

4Productivity

If the coating is applied to ensure rapid transfer, then the drug delivery efficiency is improved, but the release control may be compromised

Engineering Contradiction:

Core Design Contradiction:

ProductivityVSManufacturing precision

Solution Approach 1:

The pharmaceutical agent particles are pre-encapsulated in polymer shells before being coated onto the balloon surface. This preliminary encapsulation action ensures that the controlled release mechanism is already in place, allowing rapid transfer without compromising release precision.

Inventive Principle:

Principle #10Preliminary action

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 controlled and efficient release of the pharmaceutical agent at the target site, ensuring safe and effective drug delivery.

Implementation Method 1

the pharmaceutical agent is at least partially encapsulated in the polymer layer by spray-drying a mixture of the pharmaceutical agent, the polymer, and a solvent

Methodology Applied

Scientific EffectSpray-drying: Spray

Implementation Method 2

the polymer layer has an average thickness of from 2 microns to 20 microns

Methodology Applied

Scientific EffectDiffusion: Diffusion

Implementation Method 3

the pharmaceutical agent is at least partially encapsulated in the polymer material by spraying and drying a solution of the bioabsorbable polymer on the particles of the pharmaceutical agent

Methodology Applied

Scientific EffectErosion: Erosion

Data Source

PatentUS10188772B2Drug delivery medical device

Publication Date: 2019.01.29

AI summary

A medical device that releases a pharmaceutical agent to a target site is disclosed. The medical device includes a balloon, and a coating on at least a portion of the balloon. The coating includes particles of a pharmaceutical agent. Each particle of the particles of the pharmaceutical agent is at least partially encapsulated in a polymer material. A method of releasing a pharmaceutical agent at a target site is also disclosed. The method includes the steps of providing a device including a balloon, and a coating on at least a portion of the balloon, the coating including particles of a pharmaceutical agent, and each particle of the pharmaceutical agent is at least partially encapsulated in a polymer material; positioning the device to allow the balloon to reach the target site; and inflating the balloon of the device.