Multi-Site Neuromuscular Injection for Heterotopic Ossification
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Solution Overview
Problem
Heterotopic ossification (HO) is a potential complication of various injuries and medical conditions, leading to joint contracture, pain, and disability, with existing treatments causing significant muscle atrophy and bone loss.
Innovation Solution
A delivery device and method for distributing a neuromuscular inhibitor, such as botulinum toxin A (BTxA), at multiple discrete sites within the muscle tissue to inhibit HO formation, reducing the dose size and minimizing side effects by spatial distribution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a high dose of neuromuscular inhibitor is administered to inhibit HO formation, then HO inhibition effectiveness is improved, but muscle atrophy and bone loss increase
Solution Approach 1:
The patent divides the therapeutic agent administration into multiple discrete injection sites distributed throughout the target muscle region. Instead of a single high-dose injection, the total dose is segmented and delivered at multiple locations (e.g., 3-10 injection sites), which achieves effective HO inhibition while reducing localized muscle atrophy and bone loss by distributing the therapeutic effect across multiple areas.
Solution Approach 2:
The patent implements localized treatment by targeting specific muscle regions susceptible to HO formation with precise injection site selection. The therapeutic agent is delivered locally to the target muscle region rather than systemically, achieving high local concentration where needed while minimizing systemic side effects and distant tissue damage.
2Ease of operation
If a single high-dose injection is administered, then treatment simplicity is improved, but therapeutic effectiveness and side effect profile worsen
Solution Approach 1:
The patent segments the injection process into multiple discrete sites that can be systematically targeted. The device includes a template with multiple pre-defined injection sites arranged in a pattern, allowing the practitioner to efficiently administer multiple injections following a structured approach that maintains simplicity while improving therapeutic outcomes.
3Object-generated harmful factors
If multiple discrete injection sites are used to distribute therapeutic agent, then side effects are minimized, but device complexity increases
Solution Approach 1:
The delivery device template serves multiple functions: it guides needle insertion at multiple discrete sites, spaces needles at appropriate intervals, ensures proper depth of injection, and can be reused for different treatment sessions. This multi-functional design achieves the benefit of multiple injection sites while keeping the device relatively simple and cost-effective.
Data Source
AI summary
Systems for treating a targeted volume of muscle tissue to inhibit heterotopic ossification (HO) employ a delivery device including a reservoir containing a neuromuscular inhibitor and an injector assembly. The injector assembly can include an arrangement of needles and an injector operable to pass the neuromuscular inhibitor from the reservoir through the needles. The injector assembly can be configured to eject predetermined aliquots of a therapeutic dose of the neuromuscular inhibitor. The injector assembly can be shaped to compliment the targeted volume of muscle tissue within a larger volume of muscle tissue. The ejection of the predetermined aliquots can result in a therapeutic distribution of the therapeutic dose of the neuromuscular inhibitor within the targeted volume of muscle tissue that is sufficient to prevent formation of an HO lesion but insufficient to induce paralysis of the larger volume of muscle tissue.