Repositionable Catheter Cuff for Dialysis

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Solution Overview

Problem

Existing medical catheters, particularly peritoneal dialysis catheters, face challenges in securing placement due to fixed cuff positions, which can lead to discomfort and inefficiencies in fluid exchange, as the distance between cuffs and the distal end is non-variable, making it difficult to accommodate varying patient anatomies and potentially causing 'drain pain' or incomplete fluid exchange.

Innovation Solution

A catheter design with customizable cuff positions along its length, featuring a cuff body that promotes tissue growth and an adhesive for secure attachment, allowing clinicians to adjust the distance between cuffs and the distal end to better fit individual patient anatomy, enhancing stability and fluid exchange efficiency.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If fixed cuff positions are used on the catheter, then manufacturing is simplified and consistency is maintained, but adaptability to varying patient anatomies deteriorates and placement effectiveness worsens

Engineering Contradiction:
Improvecatheter manufacturing simplicityVSAvoidadaptability to patient anatomy
Core Design Contradiction:
Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The catheter incorporates cuffs that can be dynamically repositioned along its length after implantation. The cuff structure includes an adhesive layer that allows the cuff to be moved to different positions on the catheter body, enabling clinicians to optimize cuff placement based on individual patient anatomy and achieve effective anchoring without requiring complex custom manufacturing for each patient.

Inventive Principle:
Principle #15Dynamics

2Device complexity

If fixed cuff positions are used, then device complexity is reduced, but ease of operation deteriorates due to inability to optimize placement

Engineering Contradiction:
Improvecatheter structure complexityVSAvoidcuff placement optimization
Core Design Contradiction:
Device complexityVSEase of operation

Solution Approach 1:

The cuff assembly includes a repositionable design where the cuff can be detached and reattached at different locations along the catheter. This dynamic capability allows clinicians to optimize cuff placement for each patient without increasing the fundamental complexity of the catheter structure, as the repositioning mechanism uses simple adhesive bonding rather than complex mechanical systems.

Inventive Principle:
Principle #15Dynamics

3Manufacturing precision

If non-variable distance between cuff and distal end is used, then manufacturing precision is improved through standardization, but reliability deteriorates due to discomfort and inefficiencies

Engineering Contradiction:
Improvecuff position consistencyVSAvoidplacement effectiveness
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The catheter design allows the distance between the cuff and distal end to be variable by enabling cuff repositioning. After manufacturing with standardized components, the cuff can be moved to achieve the optimal distance for each patient, thereby maintaining manufacturing precision while improving placement reliability and preventing complications like drain pain.

Inventive Principle:
Principle #15Dynamics

4Adaptability or versatility

If customizable cuff positions are implemented, then adaptability to patient anatomy is improved, but device complexity increases due to additional components

Engineering Contradiction:
Improvecuff position customizationVSAvoidcatheter assembly complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The cuff assembly incorporates a repositionable mechanism consisting of a cuff body, adhesive layer, and optional reinforcement structure. This allows the cuff to be positioned at different locations along the catheter to accommodate varying patient anatomies. The added complexity is minimal and focused solely on enabling repositioning, while the rest of the catheter structure remains simple and standardized.

Inventive Principle:
Principle #15Dynamics

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 customizable cuff positions improve catheter stability and reduce movement-related issues, leading to better peritoneal dialysis outcomes by ensuring proper placement and minimizing the risk of infection and discomfort, while accommodating different patient anatomies and clinician preferences.

Implementation Method 1

an adhesive configured to adhere the first cuff body to an outer surface of the elongated catheter body at a first cuff position selectable by a user

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 2

The cuff body is formed from a material configured to promote growth of tissue and collagen on and around the cuff body material and anchor the cuff to the surrounding tissue

Methodology Applied
Scientific EffectTissue growth:

Data Source

PatentUS20220401636A1Catheter cuff
Publication Date: 2022.12.22 MOZARC MEDICAL US LLC
  • US20220401636A1 patent drawing
  • US20220401636A1 patent drawing
  • US20220401636A1 patent drawing

AI summary

In some examples, a catheter assembly includes a catheter including an elongated catheter body defining a lumen, a first cuff and a second cuff. The first cuff includes a first cuff body comprising a material configured to promote epidermal tissue growth around or within the first cuff and an adhesive configured to adhere the first cuff body to an outer surface of the elongated catheter body at a first cuff position selectable by a user. The second cuff includes a second cuff body comprising the material configured to promote epidermal tissue growth around or within the second cuff body and an adhesive configured to adhere the second cuff body to the outer surface of the elongated catheter body at a second cuff position selectable by the user. A distance between the first and second cuff positions is customizable by the user based on a patient.