Surgical Staple Bending for Patient-Specific Bone Fixation
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Solution Overview
Problem
Existing surgical staples and bone plates lack the ability to be easily tailored to the specific anatomy of a patient's bone, leading to suboptimal fixation and fusion outcomes.
Innovation Solution
A surgical bending instrument with a distal force applicator and a handle mechanism that allows for the bending of surgical staples and bone fusion plates into customized configurations suitable for patient-specific anatomy, using a threaded shaft and grips to maintain the staple during distraction and implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If standard surgical staples and bone plates are used, then the procedure is simple and quick, but the implants cannot be tailored to specific patient anatomy
Solution Approach 1:
The surgical staple is designed with dynamic flexibility, allowing it to be bent and shaped intraoperatively to match the specific anatomy of the patient's bone. The staple transitions from a rigid standard form to a customized configuration during surgery, enabling adaptability without requiring multiple pre-fabricated implant sizes.
Solution Approach 2:
The physical parameters of the surgical staple (shape, curvature, orientation) are changed during the surgical procedure to match patient-specific anatomy. This allows a single standard implant design to be adapted to various anatomical configurations by modifying its geometric parameters intraoperatively.
2Manufacturing precision
If bone plates are pre-bent to fit patient anatomy, then alignment precision improves, but the time and complexity of pre-surgical preparation increases
Solution Approach 1:
The bone plate is designed with pre-marked bending lines and predetermined bend angles that guide the surgeon during intraoperative customization. This preliminary preparation of bending indicators allows for rapid and accurate shaping during surgery without requiring extensive pre-surgical planning or custom manufacturing lead time.
Solution Approach 2:
Bending guides and alignment markers serve as intermediaries between the standard bone plate design and the patient-specific anatomical requirements. These markers facilitate precise bending during surgery by providing visual and tactile guidance, achieving custom alignment without custom manufacturing.
3Adaptability or versatility
If surgical staples are made flexible for customization, then adaptability to anatomy improves, but the structural strength and stability may be compromised
Solution Approach 1:
The surgical staple is divided into distinct segments: flexible bending zones that allow customization and rigid holding zones that maintain structural strength. The flexible segments enable shaping to match anatomy, while the rigid segments ensure adequate holding power and structural integrity once implanted.
Solution Approach 2:
Different portions of the surgical staple have different mechanical properties - the crown and leg portions are designed with varying degrees of flexibility and strength. The regions requiring bending are made more flexible, while the regions requiring holding power maintain higher rigidity, optimizing both adaptability and structural strength locally.
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 precise alignment and fixation of bones by allowing staples and plates to be bent to fit the patient's anatomy, enhancing fusion stability and alignment.
Implementation Method 1
A shaft comprising a threaded portion is rotatably engaged within the threaded hole. Rotating the proximal handle relative to the body moves the driver longitudinally relative to the body.
Implementation Method 2
The shaft communicates mechanical forces applied at the proximal handle to the driver. Twisting the proximal handle clockwise moves the driver distally into contact with the crown.
Implementation Method 3
a driver of the distal force applicator configured to exert a distally-directed force so as to bend the surgical implant
Implementation Method 4
The distal force applicator is configured to retain a surgical staple, such that the surgical staple may be changed to a distracted configuration suitable for implantation
Implementation Method 5
A distal force applicator comprises the driver centered between a first grip and a second grip. The distal force applicator is configured to retain a surgical staple
Implementation Method 6
the surgical staple being clasped between the grips and the driver
Data Source
Figure 1~2
Figure 3A~3B
Figure 4A~5B
AI summary
A method of using a surgical bending instrument for implanting a surgical staple at a bone fixation or fusion site of a patient is provided, and the method comprises: loading the surgical staple into a distal force applicator of the surgical bending instrument, such that the surgical staple is in contact with a first grip and a second grip; advancing a driver into forceable contact with a crown of the surgical staple, the surgical staple being clasped between the first grip, the second grip, and the driver; distracting the surgical staple, such that a first leg and a second leg of the surgical staple are parallel to one another; inserting the surgical staple through an incision and sliding the first and second legs into parallel holes drilled across a bone fusion or fixation site of the patient; retracting the driver from the crown so as to allow the surgical staple to compress the bone fusion or fixation site; disengaging the first and second grips from the crown; pushing the surgical staple into the parallel holes until the crown is in contact with the patient's bone; and closing the incision by way of suturing.