Shape Memory Staple Sequential Tine Delivery

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Solution Overview

Problem

Conventional surgical staplers using shape memory alloys (SMAs) are unsuitable for endoscopic procedures due to their size and require both tines to be inserted simultaneously, limiting their use in approximating tissues during endoscopic surgeries.

Innovation Solution

A medical device with an elongate shaft and a staple formed from a shape memory material, where the staple transitions from an open to a closed position at or above a transformation temperature, allowing for single-handed tissue approximation using a control wire to insert the tines sequentially.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If traditional SMA staplers are used, then the staple can be deployed, but the stapler is unsuitable for endoscopic procedures due to its size

Engineering Contradiction:
Improvesuitability for endoscopic proceduresVSAvoidstapler size
Core Design Contradiction:
Adaptability or versatilityVSVolume of moving object

Solution Approach 1:

The stapler is divided into separate components: a delivery catheter and a staple with control wire. The staple itself is segmented into a body and two tines that can be independently positioned. This segmentation allows the system to be delivered through a narrow endoscope while maintaining full functionality.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The staple is nested within the delivery catheter in a compressed state. The control wire is inserted through the catheter to deploy the staple. This nesting allows the staple delivery system to fit through the narrow working channel of an endoscope while still deploying a fully functional staple.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Ease of operation

If both tines are inserted simultaneously as in traditional SMA staplers, then the staple closes properly, but the physician cannot approximate tissues with one hand during endoscopic procedures

Engineering Contradiction:
Improvesingle-handed tissue approximationVSAvoidinsertion mechanism complexity
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The first tine is inserted and secured in the tissue before the second tine is inserted. This preliminary action allows the physician to approximate the tissue with one hand while the other hand operates the endoscope, as the staple will automatically close once both tines are in place.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

A control wire serves as an intermediary mechanism to deploy the staple sequentially. The control wire is inserted through the delivery catheter and used to push out the first tine, then the second tine, allowing controlled sequential insertion without requiring complex manual manipulation.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If both tines enter opposing sides simultaneously, then the staple fastens properly, but the tines cannot be used to gather and approximate the opposing tissues

Engineering Contradiction:
Improvetissue gathering capabilityVSAvoidincision closure efficiency
Core Design Contradiction:
Ease of operationVSProductivity

Solution Approach 1:

The first tine is inserted and positioned in the tissue before the second tine is inserted. This preliminary positioning allows the first tine to act as a guide and anchor, enabling the physician to gather and approximate the opposing tissues before completing the insertion of the second tine, thereby improving both tissue gathering capability and closure efficiency.

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 the approximation of opposing tissues with one hand, facilitating endoscopic procedures by allowing the staple to be deployed through an endoscope and reducing the need for simultaneous tissue approximation.

Implementation Method 1

The staple comprises a shape memory material and is configured to transition from the open position to a closed position at or above a transformation temperature of the shape memory material

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentUS8342376B2Medical stapler
Publication Date: 2013.01.01 COOK MEDICAL TECHNOLOGIES LLC
  • US8342376B2 patent drawing
  • US8342376B2 patent drawing
  • US8342376B2 patent drawing

AI summary

A stapler for delivering a staple formed from a shape memory material is disclosed. The staple includes a first tine and a second tine connected by a bridge. The staple may be disposed within the stapler in an open position with the first tine distal of the second tine. The stapler is configured to sequentially deliver the first tine and the second tine, respectively, to opposing body tissues. The stapler includes an elongate shaft (e.g., a catheter) having a working lumen and a control mechanism for delivering the staple. A drive cable extends along the working lumen of the elongate shaft. Upon warming up to a temperature at or above a transformation temperature of the shape memory material, the staple may assume a closed position, thus drawing together opposing body tissues and closing an incision.