Integrated Catheter Assembly Single-Point Dialysis Access

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Solution Overview

Problem

Current dialysis procedures for patients with kidney or renal system failure are uncomfortable and painful due to the frequent insertion and removal of catheters, which increases procedure time and potential infection risk.

Innovation Solution

An integrated catheter assembly with a retractable 14G needle and improved tubing management features, reducing the number of needle insertions and providing a single point of entry, thus enhancing comfort and reducing procedure time and infection risk.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple needles are inserted into the arteriovenous fistula for dialysis access, then blood flow access is achieved, but patient discomfort and pain increase

Engineering Contradiction:
Improveblood flow accessVSAvoidpatient discomfort and pain
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent combines multiple needle functions into a single integrated catheter assembly. The device integrates a introducer needle, extension needle, and catheter into one unified structure that provides both arterial and venous access through a single insertion site, eliminating the need for multiple separate needle insertions and reducing patient discomfort.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The catheter assembly is segmented into functional components (introducer needle, extension needle, catheter segments) that can be deployed sequentially through a single insertion point. This segmentation allows each component to perform its specific function while maintaining a single patient access site, reducing trauma compared to multiple separate insertions.

Inventive Principle:
Principle #1Segmentation

2Reliability

If multiple needle insertions are performed for catheter placement, then proper arteriovenous access is established, but procedure time increases

Engineering Contradiction:
Improvearteriovenous access establishmentVSAvoidprocedure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The introducer needle and extension needle are pre-assembled in a ready-to-use configuration before patient contact. The catheter is pre-loaded within the assembly, allowing for rapid deployment as a single unit. This preliminary preparation eliminates the time required for multiple separate insertion procedures and reduces overall procedure time.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

By merging the introducer needle, extension needle, and catheter into a single integrated assembly, the patent enables simultaneous placement of both arterial and venous access through one insertion event, dramatically reducing the time required compared to traditional multi-step insertion procedures.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If multiple needle insertions are performed, then dialysis access is achieved, but infection risk increases

Engineering Contradiction:
Improvedialysis accessVSAvoidinfection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent merges multiple access functions into a single catheter insertion site. By providing both arterial and venous access through one sealed catheter assembly rather than multiple separate needle insertions, the number of potential infection entry points is reduced, thereby lowering overall infection risk.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The catheter assembly is designed as a disposable single-use device that is discarded after one patient use. This eliminates the risk of cross-contamination between patients and ensures that each insertion uses a sterile, unused device, reducing infection risk associated with reusable equipment.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

4Productivity

If a larger gauge needle is used for dialysis access, then blood flow rate increases, but patient discomfort increases

Engineering Contradiction:
Improveblood flow rateVSAvoidpatient discomfort
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent employs a dynamic needle retraction mechanism where the sharp introduction needle is withdrawn after initial puncture, leaving only the softer catheter in place. This allows the use of a larger gauge needle initially to establish access and achieve high blood flow rates, while subsequently removing the source of patient discomfort during the actual dialysis procedure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The larger gauge needle is used only preliminarily to create the access pathway. Once the catheter is successfully positioned, the introduction needle is removed, leaving the catheter that provides adequate flow for dialysis without the discomfort associated with the initial larger needle presence.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS11826519B2Integrated catheter assembly
Publication Date: 2023.11.28 EVOLVE MEDICUS INC
  • US11826519B2 patent drawing
  • US11826519B2 patent drawing
  • US11826519B2 patent drawing

AI summary

An integrated catheter assembly includes a housing member, an outer lumen member extending from the housing member, and a needle member having a needle slidably or movably coupled to the housing member, wherein the needle can be extended beyond the outer lumen. Once a flash of blood is confirmed the needle member is uncoupled from the housing member and removed from within the patent's vein or artery. An inner lumen member having an elongated member housing an inner lumen is then connected to the housing member. The integrated catheter assembly therefore receives and delivers blood through a single injection site.