Band Clamp Implant for Spinal Fixation in Weak Bone

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Solution Overview

Problem

Existing band clamp implants for securing flexible bands to bone in spinal surgery lack effectiveness in providing stable fixation, especially in cases with weak bone or dysmorphic vertebrae, where traditional pedicle screw fixation is difficult or impossible.

Innovation Solution

A band clamp implant assembly that includes a spinal rod, a flexible band with an anchor, and a band clamp with a longitudinal axis, a hole for the spinal rod, and an anchor slot to secure the anchor, allowing for tensioning and stable fixation of the flexible band to the bone.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If flexible bands are used to achieve correction and provide fixation as an alternative to pedicle screws, then the treatment becomes applicable to patients with weak bone or fractured anatomy, but the bands may wear through bone or loosen over time leading to neurological injury

Engineering Contradiction:

Improveapplicability to patients with weak boneVSAvoidstability of fixation

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The patent introduces a band clamp implant as an intermediary device between the flexible band and the bone. The band clamp has a body with a band receiving portion that secures the flexible band and a bone engaging portion that attaches to the bone surface. This intermediary structure prevents the flexible band from directly contacting and wearing through the bone, while providing stable fixation through the clamp's bone engaging features such as friction fit, interference fit, or mechanical interlocking.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Ease of manufacture

If metal wires are used for posterior cervical fixation, then fixation can be achieved, but the wires have the potential to wear through bone or loosen over time leading to neurological injury

Engineering Contradiction:

Improvesimplicity of fixation techniqueVSAvoidbone wear and loosening

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The band clamp implant serves as a mediator between the metal wire/flexible band and the bone. The clamp's bone engaging portion provides a larger surface area and more distributed contact points, preventing the concentrated stress that causes wire-induced bone wear. The clamp acts as a protective interface that maintains fixation stability without the harmful effects of direct wire-bone contact.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If traditional pedicle screw fixation is used, then stable fixation is achieved, but it becomes difficult or impossible in cases with weak bone or dysmorphic vertebrae

Engineering Contradiction:

Improvestability of fixationVSAvoidapplicability to weak bone cases

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The band clamp implant changes the local quality of the fixation interface from deep bone penetration (screws) to surface-level bone engagement. The bone engaging portion can utilize the bone's outer surface, cortical shell, or lamina, which maintains structural integrity even when internal bone density is compromised. This local adaptation allows fixation in dysmorphic vertebrae where pedicle screw placement is not feasible.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The invention changes the fixation parameters from high-insertion-force deep anchoring to distributed surface contact. The band clamp distributes fixation forces across a larger bone surface area, reducing stress concentration on any single point. This parameter change enables safe fixation in patients with osteoporosis, pediatric bone, or dysmorphic vertebrae where traditional screw fixation would fail or cause bone damage.

Inventive Principle:

Principle #35Parameter changes

4Ease of operation

If flexible bands are tensioned to provide fixation, then correction of spinal deformity is achieved, but the bands require secure attachment to prevent loosening over time

Engineering Contradiction:

Improveability to apply tension for correctionVSAvoidlong-term stability against loosening

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The band clamp implant is pre-configured with a band receiving portion designed to securely hold the flexible band in place. The clamp's internal geometry, friction characteristics, and locking mechanisms are prepared in advance to prevent band slippage or loosening during the tensioning process and throughout long-term use. This preliminary design ensures that when tension is applied for spinal correction, the band remains firmly attached without requiring additional securing steps.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS12213706B2Systems and methods for surgical procedures using band clamp implants and tensioning instruments

Publication Date: 2025.02.04 GLOBUS MEDICAL INC

AI summary

Implants, systems, and methods for securing a flexible band, thereby providing a desired correction to the spine. The implant may secure the flexible band to a spinal rod and/or a pedicle screw. The implant has a locking mechanism to secure the band. The band may be looped around bony anatomy and tensioned to achieve correction and provide fixation as an alternative or supplement to pedicle screws and spinal rods during spinal deformity surgery.