Suture Needle Package with Alignment Guide for Trocar Passage

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Solution Overview

Problem

Surgeons face difficulties in passing larger suture needles through smaller trocars during minimally invasive surgeries, leading to longer procedures and increased risk of wound dehiscence due to the need for smaller needles, which can cause a 'cheese wire effect' and are less effective in holding tissue.

Innovation Solution

A suture needle made of hyper-elastic or superelastic material, such as Nitinol, that can be elastically deformed to fit through smaller trocars, combined with a needle driver system that secures and protects the tip of the needle to prevent damage and facilitates easier passage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If larger suture needles are used to improve wound closure efficiency, then productivity is improved, but the needle cannot be passed through smaller trocars used in minimally invasive surgeries

Engineering Contradiction:
Improvewound closure efficiencyVSAvoidability to pass needle through trocar
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The suture needle is designed with dynamic shape-changing capability using superelastic material (Nitinol). The needle can transform from a curved configuration during passage through the trocar to a straight configuration when engaged by the needle driver, enabling it to adapt its shape to different spatial constraints during the surgical procedure.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The needle's physical parameters (shape, curvature) are changed by utilizing the superelastic properties of Nitinol material. The material allows the needle to be deformed into a compact curved shape for passing through the 5mm trocar, then returns to or is maintained in a straight shape for effective tissue engagement, thus changing geometric parameters to resolve the contradiction.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If smaller suture needles are used to pass through smaller trocars, then ease of operation is improved, but the procedure time increases and wound dehiscence risk increases

Engineering Contradiction:
Improveability to pass needle through trocarVSAvoidprocedure time
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The dynamic shape-changing needle allows surgeons to use larger diameter needles (which require fewer passes and provide better tissue holding) by deforming them into a compact shape for trocar passage. This eliminates the time loss associated with using smaller needles that require multiple passes.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

By changing the geometric parameters of the needle (curvature, effective length) through superelastic deformation, the system enables passage of larger needles through small trocars, thereby reducing the number of passes needed and decreasing overall procedure time.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If smaller suture needles are used, then ease of operation is improved, but the needle tip may damage tissue or cut through tissue (cheese wire effect)

Engineering Contradiction:
Improveability to pass needle through trocarVSAvoidtissue damage and cheese wire effect
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The needle maintains a straight configuration when engaged by the needle driver during tissue penetration, providing structural integrity and preventing the cheese wire effect. The dynamic shape change only occurs during trocar passage, not during tissue engagement, thus eliminating tissue damage risks.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The needle's geometric parameters are optimized for different phases: curved and compact during trocar passage, then straight and rigid during tissue engagement. This parameter change ensures adequate bite distance and prevents cutting through tissue while maintaining ease of passage.

Inventive Principle:
Principle #35Parameter changes

4Ease of operation

If the needle tip is exposed during passage through the trocar, then ease of operation is improved for engagement, but the tip may contact the trocar and become damaged

Engineering Contradiction:
Improveneedle engagementVSAvoidneedle tip integrity
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The needle is pre-configured in a curved shape with the tip retracted within the body of the needle during storage and trocar passage. This preliminary protective positioning prevents tip contact with the trocar walls, and the needle driver is designed to engage the needle body rather than the tip during the passage phase.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The needle dynamically changes from a protected curved configuration during trocar passage to an engaged straight configuration when the needle driver grasps the needle body. This dynamic transition ensures tip protection during vulnerable passage while enabling proper engagement for subsequent surgical use.

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

Enables the use of larger suture needles through smaller trocars with reduced force requirement, minimizing tissue trauma and improving wound closure efficiency by maintaining the needle's integrity during passage.

Implementation Method 1

the suture needle may be elastically deformed to lower the height and/or the profile of the suture needle to pass the suture needle through a trocar

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 2

A suture needle made of hyper-elastic or superelastic material, such as Nitinol

Methodology Applied
Scientific EffectSuperelasticity: Pseudoelasticity

Data Source

PatentUS11219449B2Suture needle packages for loading suture needles and methods of passing suture needles through trocars
Publication Date: 2022.01.11 ETHICON INC
  • US11219449B2 patent drawing
  • US11219449B2 patent drawing
  • US11219449B2 patent drawing

AI summary

A system for aligning a needle driver with a tip of a suture needle includes a suture needle package having a base, a needle driver alignment guide, and at least one connector for securing the suture needle. The needle driver alignment guide has first and second lateral guide walls that oppose one another for defining a needle driver guide channel. An end wall interconnects the first and second lateral guide walls for defining a distal end of the needle driver alignment guide. The at least one connector secures the suture needle over the base and controls the orientation of the suture needle so that a tip of the suture needle is located within the suture needle guide channel and is bounded by the end wall and the first and second lateral guide walls. A needle driver has a clamping assembly at a distal end that engages the end wall of the needle driver alignment guide for aligning the clamping assembly with the tip of the suture needle.