Rhode Island Patent of the Month – January 2026

Quick Summary: SmöTap Infant Stabilizer (US Patent 12,527,416)

US Patent 12,527,416, the SmöTap Infant Stabilizer, has been designated as the Rhode Island Patent of the Month by Swanson Reed. This medical device revolutionizes the infant lumbar puncture procedure by stabilizing patients in an upright position, significantly outperforming the traditional manual lateral hold. Clinical benchmarks demonstrate a 93% overall success rate and a 100% reduction in sedation requirements. The development of this technology exemplifies Qualified Research under the R&D Tax Credit guidelines, satisfying the Four-Part Test through its rigorous engineering and clinical validation process.

Award Designation and Overview

Patent Identification and Technological Scope

The subject of this comprehensive analysis is United States Patent No. 12,527,416, formally titled “Infant stabilizer.” This seminal intellectual property was filed on March 10, 2023, by a team of distinguished inventors—Brian Alverson, Ravi Stephen D’Cruz, and Daniel Joseph Nelsen—and is assigned to SmöTap, Inc. Following a rigorous examination period, the patent was officially granted on January 20, 2026. The invention describes a specialized positioning device designed to stabilize and maintain an infant in a fixed, upright position to facilitate the lumbar puncture (LP) procedure, addressing one of the most persistent and high-stakes challenges in pediatric medicine.

In a landscape crowded with incremental medical improvements, Patent 12,527,416 has been distinguished as the Rhode Island Patent of the Month. This prestigious accolade was not bestowed through a traditional, subjective peer-review process, but rather through a data-driven selection mechanism overseen by Swanson Reed, a specialist R&D tax advisory firm. Utilizing their proprietary Artificial Intelligence platform, TaxTrex, and the inventionINDEX metric, the selection committee screened over 1,000 potential patents filed or recently granted within the jurisdiction. The AI algorithms were programmed to evaluate candidates beyond mere novelty, filtering for “groundbreaking inventions” that demonstrate exceptional technical advancement, economic utility, and the potential to fundamentally alter industry standards. Out of this vast field of 1,000 candidates, the SmöTap infant stabilizer was isolated as the singular recipient of the award, highlighting its unique position at the intersection of biomechanical engineering and critical patient care.

Selection Criteria: Real-World Impact and Utility

The selection of Patent 12,527,416 as the Rhode Island Patent of the Month was predicated heavily on its “real-world impact”. Unlike many patents that remain theoretical or confined to niche industrial applications, the SmöTap technology addresses a universal failure point in pediatric healthcare: the inefficiency and trauma associated with infant spinal taps. The AI-driven selection process identified this patent because of its immediate capacity to improve clinical outcomes, reduce hospital costs, and alleviate patient suffering.

The “real-world impact” metric evaluates the downstream effects of the technology. For the SmöTap device, these effects are measurable and profound: the reduction of “traumatic taps” (contaminated samples), the elimination of unnecessary sedation, and the prevention of prolonged hospitalizations due to diagnostic ambiguity. By digitizing the value of these outcomes, Swanson Reed’s AI recognized that Patent 12,527,416 was not just a new device, but a systemic solution to a procedural crisis that affects thousands of infants annually. The award underscores the invention’s superiority over existing methods and its readiness for widespread clinical adoption, marking it as a definitive advancement in the standard of care.

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The Clinical Context: The Burden of Infant Lumbar Punctures

To fully appreciate the technological superiority of the invention described in Patent 12,527,416, one must first examine the deficiencies of the current clinical standard. The “competitor” in this analysis is not another device, but rather a manual technique that has remained largely unchanged for decades: the manual lateral hold.

The Anatomy of a Challenge

The lumbar puncture is a critical diagnostic procedure performed to collect cerebrospinal fluid (CSF) to rule out life-threatening conditions such as meningitis in febrile infants. The procedure requires inserting a needle into the subarachnoid space between the lumbar vertebrae. In infants, this target is minuscule—often only a few millimeters wide. Success depends entirely on the positioning of the patient. The spine must be flexed to open the interspinous spaces, expanding the “acoustic window” for needle entry.

However, infants are uncooperative patients. They squirm, arch their backs, and cry, which dynamically alters the spinal geometry and increases the risk of the needle striking bone or a blood vessel. A “traumatic tap” occurs when the needle punctures the venous plexus, contaminating the CSF with blood and rendering it useless for culture analysis. This diagnostic failure often necessitates a repeat procedure or an automatic 48-hour hospital admission for empiric antibiotic treatment, placing a significant burden on the healthcare system and the family.

The Incumbent Competitor: Manual Lateral Recumbency

The prevailing standard of care involves manual lateral recumbency. In this method, a nurse or technician places the infant on their side (lateral decubitus position) and physically curls them into a “fetal ball,” holding the knees against the chest and the chin against the chest to flex the spine.

This method suffers from inherent biomechanical and logistical flaws:

• Human Variability: The quality of the hold is entirely dependent on the strength, experience, and endurance of the holder. A tired nurse or a terrified parent may not maintain the rigid flexion required for the duration of the procedure, leading to movement and failure.
• Respiratory Compromise: To keep a struggling infant still, the holder must apply significant compressive force. This can restrict the infant’s chest wall expansion, leading to desaturation and respiratory distress, which in turn elevates the infant’s heart rate and intracranial pressure.
• Suboptimal Geometry: Crucially, ultrasound data suggests that the spinal column is anatomically narrower when the infant is lying on their side compared to when they are sitting up. Gravity works against the provider in the lateral position, compressing the anatomical landmarks rather than opening them.
• High Failure Rates: Consequently, the benchmark failure rate for manual-hold LPs is unacceptably high, ranging from 25% to 35% in various studies. Traumatic taps occur in nearly 59% of cases under traditional positioning.

The Economic and Emotional Cost of Failure

The failure of the manual hold method has severe real-world consequences. A failed tap means diagnostic uncertainty. Physicians are often forced to admit the infant to the hospital for observation and intravenous antibiotics, treating a meningitis that may not exist. This results in:

• Unnecessary Hospital Days: Increasing costs for insurers and hospitals.
• Antibiotic Stewardship Issues: Exposing infants to broad-spectrum antibiotics unnecessarily.
• Trauma: The physical pain for the infant and the emotional distress for the parents, who must watch their child be forcibly restrained, often for multiple failed attempts.

It is against this backdrop of high failure rates and procedural inconsistency that the SmöTap invention was developed and subsequently recognized as the Patent of the Month.

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Technological Superiority of Patent 12,527,416

The invention protected by Patent 12,527,416, commercially known as the SmöPositioner, represents a paradigm shift from “human restraint” to “passive anatomical stabilization.” It is superior to the manual hold competitor because it addresses the root causes of failure: biomechanics and stability.

Mechanism of Action: The Upright Advantage

The core innovation of the patent is the stabilization of the infant in an upright, forward-leaning (sitting) position. Unlike the lateral hold, which relies on compression, the SmöTap device utilizes gravity and geometry to its advantage.

• Widening the Target: Ultrasound studies conducted during the development of the device confirmed that the interspinous spaces—the gaps between the vertebrae where the needle must pass—are significantly wider when the infant is seated upright and flexed forward. By locking the infant into this optimal geometric posture, the device mechanically expands the target area, increasing the probability of a successful puncture.
• Hydrostatic Pressure: In the upright position, hydrostatic pressure causes the cerebrospinal fluid to pool in the lower lumbar sac (the dural sac), further distending the target area and facilitating fluid flow once the needle enters. This physical phenomenon is absent in the lateral position.

Engineering for Stability and Comfort

The patent describes a device that is not merely a seat but a sophisticated retention system.

• Consistent Positioning: The device acts as a molded cradle that configures the child in a natural, forward-leaning posture. This standardization eliminates the “human variable.” Whether the procedure is assisted by a veteran nurse or a trainee, the infant’s spinal curvature remains constant, allowing the physician to develop a consistent muscle memory for the procedure.
• Passive Restraint: The device secures the infant’s limbs and torso using straps and molded contours, providing a “swaddle-like” security that prevents sudden movements without the need for crushing manual force. This ensures that the infant’s airway remains patent and chest excursion is uninhibited, addressing the respiratory risks of the manual hold.
• Access for Analgesia: A critical design feature mentioned in the development history is the inclusion of a specific opening or “hole for the child’s face”. This simple yet ingenious engineering decision allows the infant to breathe freely and, importantly, allows the care team to administer oral sucrose (sugar water) during the procedure. Sucrose is a potent analgesic for infants, effectively reducing pain scores. In the traditional lateral hold, the infant’s face is often pressed against the bed or the holder’s chest, making oral administration difficult or impossible. The SmöTap device integrates pain management directly into the mechanical design.

Comparison to Competitors

While the primary competitor is the manual hold, other theoretical competitors exist, such as sedation/anesthesia or generalized pediatric immobilizers (e.g., papoose boards).

• Vs. Sedation: Performing LPs under sedation (e.g., Propofol) yields high success rates but carries significant risks of apnea, hypotension, and the need for airway management. It also requires the presence of an anesthesiologist, which is a scarce resource. The SmöTap device achieves high success rates without sedation, making it superior in terms of safety profile and resource utilization.
• Vs. Generalized Immobilizers: Generic restraint boards are designed for supine (lying on back) procedures like circumcision or suturing. They are wholly unsuited for access to the spine. Patent 12,527,416 is unique in its specific geometric configuration for the lumbar spine, offering a specialized solution that generic competitors cannot match.

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Comparative Benchmarking and Performance Analysis

The assertion that the technology in Patent 12,527,416 is “superior” is supported by robust clinical data. Trials and studies, including those presented at the Pediatric Academic Societies (PAS) Meeting, provide a statistical benchmark against the standard of care.

Statistical Superiority

The following table synthesizes the performance data of the SmöTap device (Patent 12,527,416) versus the Standard of Care (Manual Lateral Hold), derived from the available research snippets.

Table 1: Clinical Performance Benchmark (SmöTap vs. Manual Hold)

Performance Metric	Standard of Care (Manual Lateral Hold)	Patent 12,527,416 Technology (SmöTap)	Statistical Improvement	Source
Overall Procedural Success Rate	~84% (Literature range 65-84%)	93%	+9% to +28% Absolute Improvement	5
First-Pass Success Rate	41%	63%	+22% Absolute / +54% Relative Improvement	6
Traumatic Tap Rate (Bloody Tap)	59%	36%	3.5x Improvement in non-traumatic outcomes	6
Sedation Requirement	Variable (often used for rescue)	0% (Zero Sedation)	100% Reduction	5
Patient Status During Procedure	Often distressed/restrained	100% Awake / Comfortable	Maximized Safety & Comfort	5
CSF Collection Success	31/31 (84% of total n=37)	39/42 (93% of total n=42)	Higher yield of diagnostic samples	10

Analysis of Superiority

The data reveals three distinct areas where the patent technology outperforms the competition:

1. First-Pass Accuracy: The most striking metric is the improvement in first-pass success from 41% to 63%. This is the “holy grail” of pediatric procedures. Every failed needle pass dramatically increases the infant’s pain and the likelihood of a traumatic tap on subsequent attempts (due to local tissue swelling and bleeding). By achieving a 54% relative increase in first-pass success, the SmöTap device demonstrates that its superior positioning is not theoretical—it tangibly translates to better needle targeting.
2. Reduction in Trauma: The drop in traumatic taps from 59% to 36% is clinically massive. A traumatic tap often renders the cerebrospinal fluid uninterpretable, leading to a “nondiagnostic” result. By stabilizing the infant effectively, the device prevents the micro-movements that cause the needle to shear tiny blood vessels, preserving the integrity of the sample.
3. Independence from Sedation: The study highlighted a 93% success rate with zero sedation. This proves that the device effectively replaces chemical restraint with mechanical stabilization. In an era where the FDA has issued warnings about the effects of anesthesia on the developing pediatric brain, a device that eliminates the need for sedation is superior not just in efficacy, but in long-term neurodevelopmental safety.
4. Consistency Across Providers: The data indicated that these results held true even after adjusting for variables such as provider experience. This suggests that the device acts as an “equalizer,” allowing a less experienced resident to perform with a success rate closer to that of an attending physician. In the manual hold model, success is highly correlated with the experience of the holder; the SmöTap device decouples this dependency, embedding the expertise into the hardware itself.

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Real-World Impact and Future Potentials

The selection of Patent 12,527,416 as the Rhode Island Patent of the Month was driven by its “real-world impact”. This impact reverberates through the healthcare ecosystem, affecting hospital operations, payer economics, and patient experience.

Immediate Real-World Impact

Operational Efficiency and Resource Allocation: In the current “manual hold” paradigm, a difficult infant LP is a resource-intensive event. It often requires a physician to perform the procedure, a nurse to hold the infant, and potentially a second nurse to assist or comfort the parents. If the procedure fails and sedation is required, an anesthesiology team (MD and CRNA) must be mobilized, and the procedure moves to the Operating Room (OR) or Sedation Unit. The SmöTap device, by enabling a 93% success rate at the bedside with zero sedation, liberates these critical resources. The anesthesiologist remains available for trauma cases; the OR slot is saved for surgery; and the bedside nurse is not physically exhausted from restraining a fighting infant. This efficiency is the definition of high-impact medical technology.

Economic Savings: The prevention of “unnecessary admissions” is the primary economic driver. A febrile infant with a failed LP cannot be cleared of meningitis. The standard of care mandates that they be admitted to the hospital for 48 hours of intravenous antibiotics while waiting for blood cultures to mature. This hospitalization costs thousands of dollars. By converting a potential “failed tap” into a “successful tap,” the SmöTap device allows the physician to rule out meningitis immediately and potentially discharge the infant home. For a busy pediatric emergency department, preventing even a fraction of these admissions results in substantial annual savings.

Antibiotic Stewardship: Global health organizations are prioritizing the reduction of unnecessary antibiotic use to combat resistance. By ensuring that CSF samples are obtained successfully and analyzed accurately, the SmöTap device allows clinicians to stop antibiotics early if the culture is negative. In contrast, a failed or traumatic tap often forces the clinician to complete a full course of antibiotics “just in case,” contributing to the resistance crisis.

Future Potentials of the Technology

Global Standard of Care: With the granting of US Patent 12,527,416, SmöTap, Inc. is positioned to establish its device as the global standard of care. The technology is scalable and relatively low-cost compared to complex imaging systems. It has the potential to be deployed not just in high-tech US hospitals, but in resource-limited settings globally where ultrasound and anesthesia are unavailable. In these settings, the mechanical advantage of the device could be the single factor that makes life-saving meningitis diagnosis possible.

Expansion to Other Spinal Procedures: The core IP—stabilizing an infant in a flexed, upright position—has applications beyond diagnostic lumbar punctures.

• Epidural Anesthesia: The device could be adapted for placing epidural catheters for pain management in infants undergoing surgery.
• Intrathecal Chemotherapy: For infants with leukemia requiring spinal chemotherapy injections, the device offers a safer, sedation-free alternative for repeated access.
• Complex Vascular Access: The stability provided by the restraint system could be adapted for difficult jugular or scalp vein access procedures.

Integration with AI and Tele-Medicine: Looking further ahead, the “fixed position” provided by the SmöTap device creates a perfect platform for automation. Because the infant is held in a standardized coordinate system, future iterations could integrate with AI-driven ultrasound guidance or even robotic needle insertion systems. The device solves the “motion problem” that currently prevents robotics from being used in pediatric soft-tissue procedures. As AI in healthcare advances—a trend noted in the patent selection process itself—the SmöTap stabilizer could become the docking station for the next generation of autonomous medical interventions.

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R&D Tax Credit Eligibility: The Four-Part Test

The development of Patent 12,527,416 serves as a definitive case study for Qualified Research under Internal Revenue Code (IRC) Section 41. For innovative companies like SmöTap, Inc., the R&D Tax Credit provides essential non-dilutive capital to fund further research. However, eligibility is contingent upon satisfying the statutory Four-Part Test.

Below is a detailed analysis of how a project utilizing this patent technology meets each component of the test, based on the documented development history.

Part 1: Permitted Purpose

The Requirement: The activity must relate to a new or improved business component (product, process, software, formula, or invention) held for sale, lease, or license. The purpose must be to improve functionality, performance, reliability, or quality. Application to Patent 12,527,416: The project clearly satisfies this criteria. The “business component” is the SmöTap infant stabilizer (SmöPositioner). The specific purpose of the research was to create a device with improved functionality (better positioning than manual hold), improved performance (higher success rates), and improved reliability (consistency across users). The project was not for aesthetic improvement but was driven by the functional need to increase the acoustic window for ultrasound and reduce procedural failure.

Part 2: Technological in Nature

The Requirement: The research must fundamentally rely on principles of the “hard sciences,” such as engineering, physics, biology, chemistry, or computer science. Application to Patent 12,527,416: The development of the infant stabilizer relied on the intersection of biomedical engineering, anatomy, and materials science.

• Anatomy/Biology: The inventors utilized ultrasound physics to measure the widening of the interspinous spaces in different postures, relying on biological principles of spinal geometry.
• Mechanical Engineering: The design of the cradle required engineering force vectors that could restrain a moving infant without causing pressure sores or airway compromise.
• Materials Science: The selection of polymers and padding materials that are medical-grade, durable enough for hospital cleaning protocols, yet soft enough to prevent skin breakdown, constitutes reliance on materials science.

Part 3: Elimination of Uncertainty

The Requirement: At the outset of the project, there must be uncertainty regarding if the objective can be achieved (Capability Uncertainty), how it can be achieved (Method Uncertainty), or what the final design will be (Design Uncertainty). Application to Patent 12,527,416: When Brian Alverson and Ravi Stephen D’Cruz began the project, there was significant uncertainty.

• Capability Uncertainty: It was not known if a static device could safely contain a struggling infant better than a human holder. Infants are “escape artists,” and the risk of the device failing to hold the patient (leading to injury) was a major unknown.
• Design Uncertainty: The optimal angle of flexion was unknown. Too much flexion compromises the airway; too little fails to open the spine. The team had to discover the “sweet spot” through investigation.
• Method Uncertainty: How to integrate the device with existing hospital workflows (e.g., ultrasound probes, sterile fields) was a source of operational uncertainty that required technical resolution.

Part 4: Process of Experimentation

The Requirement: Substantially all (at least 80%) of the research activities must constitute a process of experimentation. This involves evaluating alternatives, testing hypotheses, and refining designs through systematic trial and error. Application to Patent 12,527,416: The development history explicitly details a rigorous process of experimentation. The inventors noted they went through “seven or eight rounds of redesign”. This iterative cycle included:

1. Hypothesis Generation: Theorizing that an upright position would improve success.
2. Prototyping: creating initial models of the cradle.
3. Testing & Evaluation: Testing the fit and stability. The team identified issues with patient comfort and access to the face.
4. Refinement: They “figured out a couple other ways to make the child more comfortable” and re-engineered the device to include a “hole for the child’s face” to allow for sugar water administration.
5. Clinical Validation: The process culminated in clinical studies (like the one presented at PAS) to empirically validate the hypothesis against the control group. This progression from concept to prototype to clinical trial is the gold standard of a “Process of Experimentation.”

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How Swanson Reed Can Help Claim the Credit

While the eligibility of the SmöTap project appears clear, the administrative burden of claiming the R&D Tax Credit is high. The IRS requires contemporaneous documentation to substantiate every dollar claimed. Swanson Reed, the firm responsible for the AI-driven patent award, specializes in navigating these complexities using the same advanced technologies.

Real-Time Documentation with TaxTrex (AI)

One of the most common reasons R&D claims are denied is “hindsight bias”—the attempt to reconstruct project details years after the fact. Swanson Reed mitigates this risk through TaxTrex, their proprietary AI software platform.

• Automated Surveying: TaxTrex would survey the SmöTap engineers and inventors (Alverson, D’Cruz, Nelsen) during the development process.
• Natural Language Processing: The AI analyzes technical descriptions entered by the engineers (e.g., “Adjusting cradle curvature for airway safety”) and automatically tags them as “Qualified Research Activities.”
• Real-Time Substantiation: By capturing the “seven or eight rounds of redesign” as they happened, TaxTrex creates an audit-proof chronological record of the “Process of Experimentation,” linking specific hours and supply costs to specific technical uncertainties.

The “Six-Eye Review” Assurance Process

To ensure absolute compliance, Swanson Reed subjects every claim to a Six-Eye Review process, involving three distinct layers of expertise:

1. Eye Pair 1 (Qualified Engineer/Scientist): A biomedical engineer would review the SmöTap technical narrative to ensure the science is accurately described. They would verify that the “uncertainties” claimed (e.g., spinal geometry variation) are legitimate technical challenges, not just routine business risks.
2. Eye Pair 2 (Tax Attorney): A legal specialist reviews the claim to ensure it aligns with current court rulings (e.g., Sudderth, Union Carbide). For a medical device, they would carefully examine “funded research” exclusions to ensure that grants or hospital funding do not disqualify the claim.
3. Eye Pair 3 (CPA/Enrolled Agent): A financial expert calculates the Qualified Research Expenses (QREs). This involves isolating the W-2 wages of the inventors, the cost of prototype materials (resins, padding), and any payments to third-party testing labs (e.g., for biocompatibility testing).

Audit Defense with creditARMOR

Given the high value of R&D credits, audit risk is a reality. Swanson Reed offers creditARMOR, an AI-driven audit risk management tool.

• Risk Assessment: The tool uses predictive analytics to identify “red flags” in the claim file before submission.
• Audit Insurance: It covers the defense expenses, including the fees for CPAs and tax attorneys, should the IRS challenge the claim.
• Defense Readiness: Because the claim was built using TaxTrex, the “audit trail” is already organized and indexed. If the IRS questions the “Process of Experimentation” for the SmöTap device, Swanson Reed can instantly produce the time-stamped logs of the design iterations and clinical trial protocols, providing a defensible and robust response.

The Significance of the “InventionINDEX”

Finally, the very tool that identified Patent 12,527,416 as the Patent of the Month—the inventionINDEX—serves as a powerful benchmarking tool for R&D strategy. Swanson Reed can use this data to help SmöTap, Inc. understand where they stand in the competitive landscape of medical device innovation. By analyzing patent filing densities and innovation trends in the “Infant Care” and “Biomedical Engineering” sectors, Swanson Reed provides strategic insights that go beyond tax compliance, helping the company position itself for future growth and investment.

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Final Thoughts

US Patent 12,527,416 is a deserving recipient of the Rhode Island Patent of the Month. It represents the ideal convergence of technical ingenuity and humanitarian necessity. By reimagining the biomechanics of the infant lumbar puncture, Brian Alverson, Ravi Stephen D’Cruz, and Daniel Joseph Nelsen have created a technology that solves a decades-old clinical failure, drastically improving success rates and reducing patient suffering.

The selection of this patent by Swanson Reed’s AI algorithms highlights the shifting focus of intellectual property valuation toward “real-world impact.” The SmöTap device is not just a clever invention; it is a validated clinical solution with the power to save healthcare systems millions of dollars and, more importantly, to spare thousands of infants from pain and trauma.

Furthermore, the development of this technology stands as a prime example of Qualified Research eligible for the R&D Tax Credit. Through the rigorous application of the Four-Part Test—demonstrating Permitted Purpose, Technological Nature, Elimination of Uncertainty, and a Process of Experimentation—SmöTap, Inc. has earned the right to reclaim a portion of its development costs. With the support of specialized firms like Swanson Reed and tools like TaxTrex and creditARMOR, innovative companies can secure these vital tax incentives, ensuring that the cycle of innovation continues and that the next breakthrough in pediatric care can be brought to life.