Ocular Injector Needle Tip Design for Suprachoroidal Access

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Solution Overview

Problem

Accessing the posterior region of the eye for medical treatment is challenging due to its small size and delicate tissues, and topical eye drops poorly penetrate this area, limiting treatment options for conditions like macular degeneration and optic nerve issues.

Innovation Solution

Development of drug formulations with a biologically active substance and a thixotropic polymeric excipient that can be injected into the suprachoroidal space, allowing for localized and sustained release of medications, combined with minimally invasive delivery devices that use needles and sensors to guide precise placement without damaging underlying tissues.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If topical eye drops are used for treatment, then the treatment approach is simple and non-invasive, but the penetration into the posterior region of the eye is poor

Engineering Contradiction:
Improvesimplicity of treatment administrationVSAvoiddrug penetration efficacy
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The invention introduces a delivery device with a needle as an intermediary tool to access the suprachoroidal space. The device includes a needle with a specific tip configuration that can penetrate the sclera and deliver medication directly to the posterior region, bridging the gap between simple administration and effective delivery.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The invention transitions from surface-level topical application to three-dimensional suprachoroidal space injection. By accessing the potential space between the choroid and sclera, the delivery system creates a new dimension for drug distribution that overcomes the limitations of two-dimensional surface application.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Reliability

If the posterior region of the eye is accessed through traditional surgical methods, then adequate access can be achieved, but the procedure becomes more invasive and complex

Engineering Contradiction:
Improveaccess to posterior regionVSAvoidcomplexity of delivery procedure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The delivery device utilizes a thin, flexible needle with a specially designed tip that can navigate through the scleral tissue. The needle's flexibility and thin profile allow it to penetrate and deliver medication with minimal tissue disruption, avoiding the need for complex surgical instrumentation.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The needle tip is designed to self-guide through the sclera using its geometric configuration. The specific tip angle and shape allow the needle to automatically follow the tissue plane and reach the suprachoroidal space without requiring complex guidance systems or multiple instrumentation steps.

Inventive Principle:
Principle #25Self-service

3Productivity

If a needle is used to access the suprachoroidal space, then direct drug delivery is possible, but there is risk of damaging the underlying choroidal tissues

Engineering Contradiction:
Improveefficiency of drug deliveryVSAvoidrisk of tissue damage
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The needle tip features an asymmetric geometric configuration with a specific bevel angle and edge orientation. This asymmetric design creates a cutting action that preferentially separates the sclera from the choroid along the natural tissue plane, allowing the needle to pass through the sclera while deflecting off the choroid to avoid penetration and tissue damage.

Inventive Principle:
Principle #4Asymmetry

Solution Approach 2:

The needle design incorporates a gradual tip transition and specific angular geometry that acts as a protective feature before the needle reaches the choroid. The geometric configuration provides a cushioning effect by distributing the mechanical stress and creating a natural stopping point at the sclera-choroid interface, preventing accidental choroid penetration.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

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 effective and localized delivery of medications to the posterior region of the eye, improving treatment options for conditions such as macular degeneration and optic nerve issues by ensuring uniform distribution and retention of the drug within the suprachoroidal space.

Implementation Method 1

a thixotropic polymeric excipient that acts as a gel-like material to spread after injection and uniformly distribute and localize the drug in a region of the suprachoroidal space

Methodology Applied
Scientific EffectThixotropy: Thixotropy

Implementation Method 2

a needle having a leading tip shaped to allow passage through scleral tissues without damage to the underlying choroidal tissues

Methodology Applied
Scientific EffectMechanical Force: Mechanical Force

Implementation Method 3

The sensor preferably responds to ultrasound, light, or differential pressure

Methodology Applied
Scientific EffectUltrasound: Ultrasound

Data Source

PatentUS11944703B2Ocular injector and methods for accessing suprachoroidal space of the eye
Publication Date: 2024.04.02 CLEARSIDE BIOMEDICAL INC
  • US11944703B2 patent drawing
  • US11944703B2 patent drawing
  • US11944703B2 patent drawing

AI summary

An ocular medical injector is provided for drug delivery. A method includes inserting a puncture member of the medical injector into the eye until the puncture member reaches the suprachoroidal space (SCS). The puncture member defines a lumen therethrough. With the puncture member disposed within the SCS, a flexible cannula is advanced distally through the lumen of the puncture member, beyond the distal end portion of the puncture member and along the SCS towards a posterior region of the eye. The flexible cannula has an atraumatic distal tip and defines a lumen therethrough. With the distal tip of the flexible cannula disposed within the SCS beyond a distal end portion of the puncture member, a therapeutic substance is administered to the SCS.