Patent Application
20230172682
N/A
The present invention relates generally to medical devices to accurately cull, and ablate unwanted biologic tissue(s) at targeted sites. Specifically, relating to cryotreatment devices and methods for inducing controlled necrosis of: moles, lesions, flat-warts, morphologies etc.; imparting a measured-ration of a cryogen. Responsible, safe, personalized-patientcare; treating humanity suffering from harmless basal-cell, to life-threatening cancer. Skills-based paradigm-shift; a Next-Gen, B2B/B2C medical asset for stakeholders who perform quality, out-patient triage.
Rory Krieger is the sole named inventor for a medical device known as: Discrete Cryosurgical Primary-Device™ (DCP-D). “A fitting turn-of-phrase to describe the medical merits of a top-tier, a la carte medical device. Indicative of an invention to which a menu of Claims is targeted for cryosurgery.”/RK
How did we get here? For said inventor, the origins of this device dates back to his formative teen-age years. “A long-suffering patient at several area dermatology clinics and family MD's where my skin-tags were under-treated & recklessly over-sprayed. Each doctor had a poor aim. Unable to shoot-straight with on-hand clinic tools. Inflicting scars. PTSD fears! MD's follow-up offering dismissive vacuous excuses, before handing me an up-coded bill! Time-after-time misguided practitioners pushed their thumbs against-the-scales;” opines inventor, Rory Krieger. “Inside Dr. Doolittle's ‘kabuki theater’ I winced. One skip-shot botched-triage (after another) from squads of lab-coat tyrants. Brazenly overplaying their hand. Naked aggression; misguided results. Out-patient triage became a PTSD white-knuckle ride. As a whistle-blower, several MD's & NPP's were flagged; siting contempt, malpractice by dystopian SOP's. Myopic. Detached from reality. Exposing dark-secrets in a clinical cottage-industry. Routinely failing naïve patients and up-coding their CPT bill.”
“Clinic-tools should be protective, compassionate, safe and inclusive. Reporting for duty, patient-centric, doing no harm. Replete with defined, well-documented CAPA (Corrective and Preventative Action) 820.100(a) (3). Legitimate safeguards with predictable outcomes. I discovered just the opposite! My dermatologists facilitated bait & switch, as a pretext for up-coded billing: half-measures, an absence of higher-quality-assets. An inconvenient truth emerged. They failed to resolve my own annual predilection of moles and warts. I still remember walking away murmuring, “They're running a parlor-game in there. I'm paying for collateral damage, brazen-ineptitude from defiant, dispassionate, smug autocrats. ADHD and tone-deaf. Quacks on-the-dole! A kitchen-table bread and butter issue for millions. Why on earth do we keep subsidizing our own demise? I learned a lot from that abuse. Patients have died. Their families now mourn. Their lives will never be the same. But I persevered. Bootstrapped. Skin-cancer became ‘the battlefield’. Sounding the alarm, I became a Patient-Rights-Activist for a pragmatic, better-safer-faster patientcare experience. A ‘Blitzkrieg Good-will Ambassador’; liberating an oppressed patronage. Advocating a quality Med Tech device to serve professionals and DIY stakeholders on the front-lines. Prevent more pain and suffering for patients who just want a fair shake.
The epithelial/epidermal layer of skin. Raising the bar for: Inclusion, Diversity, Equity, Action (IDEA). “/R.Krieger Some view healthcare providers as saviors; others as conscripts, armchair providers wolves in sheep's clothing. Long-overdue, one newcomer addresses safety and security assistance. As for this botched triage survivor (USCG/USAF serviceman), “some healthcare professionals wield authority and clinical-tools not used in the manner intended”. Leading from behind, unbecoming of their sworn profession. Violating the spirit of “do no harm.” Stymied, many employ unsafe, scorched-earth, reckless-pressurized CO2 sprayers where toxic Freon gasses blast through a tube, dispersed into a cone speculum; positioned around abnormal tissue (pooling the coolant). In other methods, a supply-tube uses a porous-tip-applicator. More commonly, a cotton Q-tip soaked-in LN2 is directly applied to the surface of the lesion (a safer measure).
Sadly, pressurized sprayers are complex, fragile accident-prone. Nozzles stick-open! Injurious to the patient. Embedded within the cottage-industry, physicians and prior art devices have a cozy, quid pro quo supplier/user/payer relationship. Patient bills routinely up-coded, inflated outside the industry “CPT Integumentary Coded System” (CPT). Technologies providers commonly use: comically opaque. Inviting user error: blemish streaks. Disturbing macabre; red-burn blisters, numerous return visits to fix botched triage. It's a perfect-storm where patient injury+casual malpractice is common. A systemic top-down problem. A provocation that under-scores the human-toll in this cottage industry. A “ground-war” heavily reliant on guess-work.
Antiquated SOP's+deficient medical tools=botched results. A chilling-reminder how conscripts, NPPs and MDs willingly spray lethal-doses of chemicals at patients, without properly masking.
Failing to isolate (mask) lesions from adjoining virgin tissue! Naked aggression, neglecting patient's Informed Consent. Worth noting, IVD-injections, chemo-peels, cauterizing and biopsies is commonly over-performed as well. At the end of the day, a minority of healthcare proxies walk-away. Leaving victimized, inhumane, keloid-scarred patients in their wake! over and over again, patient's skin-blistered, scarred. Sore and stigmatized. Socially embarrassed from a simple out-patient triage, gone-bad.
As for this inventor? His reward was a pat across the back, and a CPT up-coded bill! Another patient caught in the cross-fire; another patient bit the dust. Spotlighting a troubling-pattern of hubris, flagrant abuse. Generations in the making, this is the predicament patients are now finding themselves in. The stuff of clinical-nightmares. Critical mass. An example of life imitating art. Marking this, his own Ground-Zero moment.
A cold-war marked by mercurial moments. Posturing. Situation was tense. Internal warning bells led Krieger into “invent-mode” and social-media. According to sources, legions of long-suffering patients are writing open-letters. Embattled over nixed-triage from local dermatology clinics. Many cited by consumer-watch groups for blatant safety violations. A slippery-slope where patients are pumping their fists with raw emotions; some dying. Many openly confess to avoiding annual doctor exams citing their own PTSD fears, botched triage, visible L/T surface scarring. Chalk it up to unapologetic doctor's privilege, professional-immunity, up-coded billing, provider half-measures. A top-down, ill-equipped grip on outdated practices; led to one bottom-up, grass-roots fix. A skeletal, flexible slide-polymer mono sled-frame. A mission capable, “semi-automatic, LN2-socket Med Tech tool. “Discrete Cryosurgical Primary-Device” (DCP-D/ADV-01). DCP-D is a common-sense, all-in-one, patientcare triage system.
Following decades of repeated abuse, the time came for Krieger to lend his voice. Emboldened with fearless determination. Speaking truth-to-power on behalf of all abused patients. Breaking old-rules is how activism . . . will right-the-ship. Democratizing healthcare under a cache of Intelligent Novel Assets-On-Demand (CACHE-IN-AOD). A device with Corrective and Preventive Action (CAPA); ISO and FDA regulations built-in. Triage by the numbers, a “depot of novel safety features” providing a “mechanized forward deployed tool; supporting a masked-mandate, and ICE.” A Med Tech SecureFIT solution. A Level-2 technology having AI/AR efficiency, promoting aperture-suppressor shielding, saving virgin-tissue. Supporting authentic tenants of dermatology, and the tenor of FDA regulatory standards. DCP-D aspires to be a strategic carve-out tool in an industry desperate “to stop the bleeding and patient desertion.” Using mechanical sockets and naturally occurring “organic biomimicing shapes” to get the job done. A Technology as a Service (TaaS), plug-and-play model. Mending what is broken within ADA/AMA cryodestruction triage. A safety improvement over prior-art, predicate and 510(k) devices.
DCP-D supports: Quality Management Systems (eQMS), Regulatory Pathway Assessment (RPA), Design for Manufacturing (DFM); Human Factor Design Controls (HFD-C). Clinical R&D. Stakeholder-centric checks and balances, and FDA audits.
DCP-D is a tactical, touch and go, Rapid-Triage-Device (RTD); homing-in with gain-of-function precision and CRT friendly-fire accuracy. Ending tone-deaf healthcare abuses by: a. dangerous and deficient prior art devices, b. archaic/lagging SOP's.
A practical panacea for teens, millennials and seniors who face an uncertain future, yet need elective surgeries during COVID.
Reporting for duty, DCP-D provides leadership to stakeholders. DCP-D uses equity-based Med Tech ingenuity for clean, trouble-free, post-op ADA/AMA results.
Overcoming prior art, predicate and 510(k) deficiencies. A forward strategic-platform for novice, to board-certified MD providers. DCP-D (ADV-01) is a tactical, asymmetric-approach under modern FDA, QSIT Guided standards. A technician's-tool specializing in 1st responder patientcare, engineered to safely remove basal-tissue, and aggressive skin-cancer lesions (on epithelial/epidermal surfaces). A “Level-2, GT Unlimited-Class” hand-held asset, DCP-D promotes a “one-shot treatment without circling-back for repeated triage.” Controlling the much abused CPT up-coding (subterfuge billing). Personalized healthcare in a safe and orderly-manner. Extending elective surgery opportunities for Humanitarians without Borders; relief from economic disruptions due to a pandemic.
Cryosurgery is the destruction of tissues using biologic combination means; directed at lesions and morphologies on the epidermis (epithelial surface layers) of living skin (mucous membranes); targeting blood vessels supplying the lesion. Leveraging the use of LN2 @ −319° F., producing snow-ball ice crystals inside outgrowth cells; resulting in 100% necrosis. Lesion temperatures are dependent upon: phenotype, delivery means and method by differing biologic cryogens; plus skin temperature prior to treatment, OR-room temperatures; patient histology. Many individual and specialized factors are at play including HIPPA laws, Informed Consent, racial inequities, etc.
Removal by “destruction technique” is ADA defined as . . . “the removal of benign, pre-malignant, integumentary system tissue. Removal by any method (electro surgery, cryosurgery, laser and chemical treatment). With or without curettement; local anesthesia that does not require mechanical closure.” A procedure similar to a Holographic Augmented Reality (HAR) otoscope; specula cryosurgery; using DCP-D's bespoke Level-2 AI/AR nomenclature, under the rubric of a “lesion masked-mandate as a border-wall” that seals-in suspect/unwanted lesions, from native, homologous virgin-tissue via Human-Factor engineering.
Triage services are reported to Medicare/Medicaid, using CPT coded groups [2013 AMA CPT® Codebook: 1700x, 1711x; and 1726x]. Updated by International Statistical Classification of Diseases and Related Health Problems (ICD); World Health Organization.
Technical Problem: Dermatology Devices Hit a Brick Wall
In a face-to-fact comparison with DCP-D, we quickly learn how prior art attempts are non sequiturs. Aside from the eQMS and inputs/outputs/indications realm, many prior art predicates employ remedial, Draconian methods. A wild shot-gun approach. Missing the target. Butchering patient skin with chemicals, maligned SOPs. Lacking CAPA and ethical standards of care. Limited, irresponsible, failing traceability and discrete mannerisms. Current SOP's actually allow for botched treatment; prioritizing shady remittances over personalized patient-care. Another failing comes in their skip-shot shotgun-blast spraying method; use of highly-pressurized aerosols, and fragile-hair-trigger materials. Leading to a short life-cycle. And there's this, toxic permeability and leaching. Toxic GMO transfer. Clinical ambiguities. Infections. Heightened patient-anxiety. Malpractice fear mongering. Missing-out on Elective Procedures. Putting-off annual health screening/exams. Placing patients in the cross-hairs; facing a bleak and uncertain diagnosis.
SOPs+Systemic Tooling Failures Plague Cryosurgery Industry Botched triage, systemic injury and malpractice is directly correlated to those industry-wide failings, and the “hang-over effect” where patients cannot gain access to quality medical treatments. Due in part to the SARS-CoV-2 strain of coronavirus.
Reports reveal prior art challengers develop uncivilized, accident-prone devices with porous-borders, creating erroneous, often injurious results. Failing to bind-up a nation in pain. Mulligans plague this cottage-industry. Evil flourishes, when good men do nothing. A frontier, a cottage-industry climate where one Med Tech tool, aspires to democratize an industry. Bringing to an end the blood-letting. Malpractice. Pain-suffering. Treating morphologies responsibly.
According to an April 2018 Medicare Quarterly Provider Compliance Newsletter, “CMS's CERT contractors are reporting that they have seen an increase in E/M claims issued due to improper coding, insufficient notes, and setting confusion. In fact, ‘the 2027 improper payment rate for HIM services was 12.1 percent, accounting for 10.6 percent of the overall Medicare FFS (Fee-for-Service) improper payment rate’.”
As mentioned, improper cryotherapy is dangerous. Many botched treatments (including cauterization) leaves behind harsh, discolored, raised Keloid scarring (and PTSD trauma).
With doctors and patients now locked-in a cold-war of their own, DCP-D breaks-the-ice, without leaving critical medical surgery to chance. Breaking-ranks with SOPs and hazardous clinic tools.
Dermatology clinics store a staple of items in their coffers;
1. Liquid Nitrogen (LN2) gas in a Dewar or stainless thermos
2. A fresh bag of long, Q-tip cotton sticks
3. Needles and numbing Novocain for pre-treating affected areas
4. An electric cauterizing-rod for burning-off lesions
5. Autoclaving, UVA/UVB light, alcohol wipes, and/or a myriad of surgical, hospital and/or advanced sanitizing methods.
Over the decades, inventor-Krieger was a patient with a front-row, ring-side seat in “Doctor Doolittle's clinic.” Rushed, impetuous triage on-the-fly, became a dog & pony minstrel show. Infuriated and no longer a trusting babe in the woods, Krieger bravely under-took this challenge. Spawning R&D of the DCP-D. An FDA/ISO/ADA/AMA/CE/HIPPA compliant, Med Tech work-around.
MACRA stands for Medicare Access and CHIP Reauthorization Act. A Medicare payment law intended to govern health care payment and delivery system reform for clinicians, health systems, Medicare, and other government and commercial payers.
The law establishes a path toward a new Medicare payment system that will more closely align payment with quality of patientcare and outcomes. MACRA offers financial incentives for health care professional to participate in shared risk-bearing and coordinate varying healthcare intervention models; moving away from the antiquated, outgoing Fee-for-service (or FFS system). Physicians and other clinicians paid under the Medicare fee schedule will generally choose between participating in Alternative Payment Models (APMs); payment based upon individual performance; Merit-Based Incentive Payment System (MIPS).
Regrettably, prior art predicates fail Stages 1 & 2; “one-dimensional weathervanes who devolved into opaque copy-cats.” Providing “no substantial, disruptive or next-level technologies.” No CAPA, no Augmented Reality (AR), no preventative Artificial Intelligence (AI) nor around-the-bend counter-measures to eliminate the dreaded skip-shot triage morass. It also bears mention that: topical salicylic & brush-on chemo-peels, homeopathic salves/acids and chemical nerve agents have proven problematic, causing pain and suffering to patients.
Crossing-the-line, Brymill Cryoplate® is dispassionate; failing all fidelity litmus-tests held dear by the DCP-D. Having no “in-between”nodules” or Level-2 MIT band either. Grotesque, the device is far too large to adequately fit or service a patient from the most sensitive, to open-areas. An offensive hack-job, creating more blunders than it can solve. It fails: AI/AR, rapid triage; the Cache of Intelligent Novel Assets-On-Demand (CACHE-IN-AOD) and a masked-mandate (of smart-amenities) built into the DCP-D. Cryoplatet is poorly designed. Its gaping funnels lack the “sealing undercuts” of the DCP-D. Marking Cryoplate® as mechanically unable, and incompetent at sealing-in the devastating biologic, Liquid Nitrogen (LN2). Malpractice in the making. Speculum apertures/nodules cannot: meter, govern nor control Liquid Nitrogen. Its limitations are numerous, prone to overload and over-pooling LN2. Failing numerous objective metrics which molest, scar and deface patients. Brazen, unapologetic and apoplectic, Cryoplate® serves as a vapid, uninspiring, wrecking-ball. Rounded speculum apertures are tone-deaf; perilous as open-borders. Destroying virgin skin. A wily-old campaigner, Cryoplate® is a “misfit-toy” in today's performance-based healthcare. A Public Health Hazard (PHH) that abridges the public trust while prone to medical malpractice litigation. In a manner of speaking “another one bites the dust!” Failing to match DCP-D's deep-bench. Deficient and inappropriate for triage. Lacking in: 3D HD, AI/AR holographic, CAPA cryotherapy. Comparatively, DCP-D uses a multitude of aperture sockets. Spec-Ops-7 alone measure: 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm and 8 mm! With many larger, tactical IMPs to spare; “sweeping-clean” 90%+ of unwanted-lesions, commonly found growing across normal patient bodies. Cryoplate® is Nolo contendere. Thus, DCP-D overcomes this device. Empowered by a plethora of: supportive, bilateral biomimicry. Using novel, Level-2 GT-Class assets. Discrete, ethical; safety-minded medical tooling. Producing customized patient-care for humanity.
Murphy's Law+Prior Art=Doomed Confirmation-Bias Results
Dispassionate, emboldened. Uninspired and lacking humility; healthcare proxies have done their own bottom-line bidding. Prior art pundits inflate the value of their assets. Most employ harmful, misdirected widgets with constituent parts. Most have many attachment assemblies with fragile-bits. Complex multi-piece assemblies. Fail-prone, aerosol Trojan-horses embedded in many armchair clinics. Gas-lighting procedural gaffs. Stumbling dystopian hack-jobs who lack transparency. Traitors to the “Do No Harm” standard. Disguised as “legitimate medical solutions, doing a high-wire act.” It's a cautionary tale how each dystopian, non-essential device trades profits, above patient care (as subjugated patients rise-up from the front-lines). Another comparison comes down to essential devices, versus non-essential devices during COVID, for family-medicinal purposes.
Comparatively speaking, challenger devices are draconian widow-makers. Absent DCP-D's deep-bench of: AI/AR, cryosurgical dialed-in the zone discretion. Imposters parading “as the real-deal.” Prioritizing profits over quality-care. A careful examination of predicate nomenclature reveals they completely miss “the CAPA imperative.” But what they don't disclose is more startling . . . their offerings are “subject to errors, omissions, change or withdrawal without notice (or ADA/AMA approval).” Human rights abuses. Absent the cache of 3D biomimicry tooling. Failing the Hippocratic Oath of Doing-No-Harm and limited by Neanderthal thinking. A false-flag. Innocent patients between the cross-hairs. Absent is an arsenal of pioneering technology: Panoramic HD Surround-Vision, Broad-shoulders, a Backbone, Edge-Glide-Rails; Spec-Ops/I-OPS accuracy or safety-net of Level-2 bioengineering. Level-2 is a “confederation united by a circumferential, MIT terraced-band.” Several predicate devices, despite being FDA 510(k) approved employ: caustic, rocket-fired, cancer-causing aerosol propellants directly at patients! Inadequate, short-sighted, unequally-yoked, unethical and rather crude. Subjecting patients to “unfounded chemical bombardment.” A Hail-Mary, evasive approach upon besieged patrons. Failing customized patientcare. Falling-short of DCP-D's: safe, security-guarantees and continuity of leadership. Absent are DCP-D's full-service Spec-Ops-7 (short-range strategic arsenal of 7 UHD/IMPs: 2, 3, 4, 5, 6, 7, 8 mm). A stakeholder controlled “petcock effect” where specific lesions are trained-on Sweet Spot/Danger Zones: eye-sockets, genitals; public and private “dark-places.” Larger, tactical IMP socket-keys further extend Close Quarter Combat (CQC) range; saving untold human lives.
As a Level-2, GT Unlimited-Class Rx tool, technical triage made easy; DCP-D places lesions in Stage-1 of Suspended-Animation. Moles, tags etc. are in close-quarter-hold. Facilitating a Just-in-Time, Frozen-in-Time frozen tourniquet proposition. Asserting Micro-G downforce, utilizing a multitude of leveraged suspension dynamics. Prepped, pre-staged and clinically pre-positioned for Stage-2 cryodestruction procedures. Over-engineered, it-breaks old rules and overcomes deficiencies of SOP predicate devices. A disruptive family hospital platform designed to Serve-and-Protect patients suffering from benign to aggressive skin-cancers. Placing lesions inside a structured, walled, pre-triage framework. Producing a precision hole-shot through an IMP “Eye of the Tiger” site picture. Locked and loaded; most lesions will die in a decisive, ground-fight shoot-out with DCP-D.
Born from a Krieger-Amulet-TaaSa method, DCP-D is multi-dimensional. Compassionate. Setting new, clinical-rules of engagement. R&D is based on Regulatory Pathway Assessment (RPA). Peer-reviewed and scrutinized under CAPA, cGMP, and pre-emptive best-practices by MDs. Producing traceability, accountability. Close-Quarter-Hold (CQH); tourniquet auto-locks (like LEGO® blocks); using “aperture-suppressors” formed around naturally occurring lesion-shapes. IMPS act as Braille picture-puzzle-pieces (the Braille-effect). Redundancy. Fast user set-up. Quick-draw transition. Able to circle-back to re-treat any nagging lesion. A clean, tactical, operational routine. DCP-D incorporates “Halos”. High-Altitude, Low-Opening IMPs. IMPs are purpose-built, data-points. 3D engineered. Workflow optimized. Leveraged upon an ability to delve into tight, outlying areas. Operational logistics. A physician-extender. Quality-care replete with AI/AR safe guards. Sufficient deterrence's against lesion regrowth (recidivism).
Artisan-styled. A single-unit, sled-like device. Skeletal-Girder-Kinetic-Exoframe chassis produces the Braille-effect. A nomenclature designed specifically for sub-zero use/reuse under UV/IR clinical autoclave sanitation protocols. Medical-grade materials having exceptional: moisture, chemical, virus-barriers (CDC attributes). ADV-01/DCP-D incorporates cGMP durable Nano-tech jacketed-coatings or layering composites. Stakeholders may autoclave & sanitize DCP-D enumerable times, without degradation to device. Adding value to the supply chain. DCP-D is sustainable. A green décor product. A unique, crafted blend of Ui/Ux inspired Med Tech. Carbon-neutral. Humanitarian values.
Outwardly-biased winglets gently pry and hold open skin-folds during Stages 1 & 2 cryotherapy. “If a safer, superior technology exists” (the argument goes), “Are dermatologist-providers ethically duty-bound to explore using DCP-D?”
DCP-D glides. It surfs. It floats and skims across the skin, effortlessly. Defying SOPs and the laws of gravity, using downforce-ergonomics and precision; incorporating a plurality of Under-Body Edge-Glide Rails that pries and holds-open sweaty, hairy skin-folds. Maintaining “track-position” inside tense, uncertain situations without slipping or fowling triage. CAPA-precision hole-shot accuracy. Leveraging-in preset, molded-in Spec-Ops-7 cluster. Conforming lesions; transforming tissue. DCP-D sticks the landing without substitution or dilution.
Using MIT/IMP-keys circumferentially conforms nevus and tags; profiling lesions. MIT is a design-canvas characterized as a Level-2 terraced perimeter band “teocalliesque”. Thicker than a majority of skeletal Exoframe chassis (slide-polymer frame). Having no IVD needles, no balloon cannulas, biopsies, old-school otoscope speculum; or antiquated SOP's. Closing porous-borders. IMP's are cryofire walls, able to focus, target and choke-off lesions. Building walls. Encircling. Safe gain-of-function destruction. Taking-out the guesswork. Consistent. Repeatable.
Of note, a Next Gen 2.0 improvement over standard holographic otoscope; funneled specula of old. Augmented Reality (AR), Artificial Intelligence (AI) interfaces, producing Rapid Triage Elements. Ground-zero, optimized, binary, user-interface index. By regulation DCP-D fits squarely into a specific FDA field of . . . “General Surgical Tools and Accessories.”
A design-canvas-matrix, Holographic Augmented Reality (HAR); in-situ lesion containment system. An easily mastered Rx skill-set.
III. End Goal of Med Tech Device
Shown herein is “a manner and process” of making & using DCP-D . . . “in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains (or with which it is most nearly connected), to make and use the same, and shall set forth the best mode contemplated by this sole inventor; Rory Krieger. For purposes of discovery, inventor and stakeholder addresses “common lesions found growing on healthy-normal-people.”Many patients suffer with Stage-4 skin cancer; where some are also prime-time, out-patient candidates for tailor-made, personalized treatments. To that end, DCP-D does not address a myriad of dreadful, exotic, oncological or zoological aberrations that also exist. Nor indulge the twisted circus-freaks, or a gaggle of case-studies ripped from the pages of “Ripley's Believe it or Not!” DCP-D and ADV-0l are identical.
Pocket, lab-coat sized Form-Factor (FF), ADV-01 requires a combination biologic cryogen means, to perform its duties. Favoring the cryo-liquid LN2 (as preferred biologic of choice); executing the “metered hole-shot.” Judiciously applied LN2 will adequately effect the desired result; necrosis. “Off-grid” this device is not AC/DC, or battery powered. DCP-D “co-pilots the user” to: rotate, gimbal, pitch/twist, cross-thread, crab-walk, straddle, back-side rodeo; Half-pipe 180° Swing-set, and moon-walk across a patient's skin. Skill-based triage. Taking ownership of On-Demand Cryotherapy. Human Factor (HF) simplicity-by-design. Dialed-in, purpose-built, COVID-compliant. Humanity served by a single-unit Ui/Ux empowered primary-device.
3D Holographic AI, with gain-of-function. “Zero-G micro-gravity” redundancy; Just-In-Time (JIT) with unblemished symbiotic best-practices. Taking triage to the edge of simplicity. Add it all up and DCP-D (ADV-01) achieves . . . “non-obvious material to patentability of the invention claimed in this non-provisional utility application.” Hardness of frozen tissue is critical in triage; and a key consideration for depth of cryogenic therapeutic treatments and dermabrasion. ADA classified range: superficial (0.2-0.5 mm), moderate (0.5-1.0 mm), or deep (1.5-2.0 mm). DCP-D utilizes a safety-gantry halfpipe design for quick transition. Substantially protecting patient from an LN2 spill.
DCP-D Wand is FDA designated as a non-active. A stand-alone device (with no constituent parts). DCP-D (ADV-01) does not require electricity, radiation, LEDS, needles, cannulas, tubes, etc. Not FDA designated as: IVD (Class-2 or Class-3).
DCP-D mandates use of: a biologic Combination means: direct LN2, cryopens, cryogun, mini-cryogun; pressurized spray-on Freon gas, etc.). DCP-D also interfaces with non-biologics: cryopen/probes.
The biologic allows DCP-D to fully produce destructive Stage-2 cryogenic necrosis (when applied carefully). A de-risking tool for LMI's contain: molded-in mosaic-socket patterns. Angled, canted, Multi Factor Authentication organic aperture-suppressor IMP-keys with relief under-cuts. Based-upon a carefully-balanced-array of Just-In-Time (JIT), Rapid Triage Elements (RTE); bio-motion recognition. E20-11 (Easy to Operate-11).
B2B Enterprise Collaboration+B2C Beneficiary Stakeholders
A single-source-solution unit without Constituent Parts; DCP-D uses a cryogen means . . . as its only Combination Part, performing cutaneous cryosurgery. Prolonged reagent penetration, with precision targeting and safety. Extending the value-chain, DCP-D has a deep-bench in this dual-vector cottage industry. A safe, proprietary, disruptive, bespoke, workflow-optimized tool. Multiple working volumes. Internal “X-Y-Z counter-balancing.” Molded into a professional-grade, shirt pocket-sized form-factor (FF). Rugged-design. The Total Product Life Cycle (TPLC) of DCP-D/ADV-01 is long-term; multi-use. Shared-mobility compliant; a multi-use Med Tech, with an extended life-span. Sanitize, and reuse it over and over again. A binary user-interface. Should DCP-D break? It's bio-recyclable (green). Environmentally sound.
Doctors and patients know lesion isolation is key. On a case-by-case basis, a patient's trust in their doctor is contingent. With so much to live for, stakeholders know “border-walls around lesions, save-lives!” Use of a novel, disruptive Med Tech, DCP-D fits into: battlefield readiness, medical tourism, OB-GYN, L.G.B.T.Q.I.A.+ friendly. Cosmetic, oncological, cryotherapy device (and the like) designed for general dermatological triage by: LMI's (Licensed Medical Intermediaries), NPP's, conscripts and OTC-DIY home healthcare. Ui/Ux precision designed for high-definition (HD) “Manual surgical instrument for general use” [21 CFR Parts 862-892].
For B2C home healthcare markets, the same methodologies apply. Each market segment uses the same 2-Step process. Treating the same broad-range of common epidermal pathologies, plus skin disorders including: A.K., acrochordon, basal-cell, squamous cell carcinoma (SCC), cancerous lesions, cysts, flat-warts, keloids, lentigo, mucocle cysts (wart clusters), moles, morphologies, peduncle-hanging warts, S.K. and many other types. Employing a Human Factor (HF) technology that is intuitive. DCP-D is packed with feature-rich nomenclature that no “prior art device” offers. “Animated, dancing across-the-skin. A coordinated, surgical-attack. Designed and built for shrewd stakeholders who demand more of themselves and their patients.”
Identifying Epithelial Abnormalities
Lesions are treated on the outer-epidermal (visual surface-layer) of viable living tissue. As such, DCP-D does not take biopsies, nor use of radiation, MRI, IVD needles or IVD balloon-catheters. DCP-D is non-obvious (horse of a different mother). Clean, green; sustainable, responsible. Surpassing the reckless futility of each prior art predicate. A “witches-brew of trap-door devices” targeting naïve, trusting-patients (and the shills who promote their Trojan-horse iterations). The gaggle of contraptions favoring profits over patient-care; in their apparent scorched-earth model and callously dismissive post-op lack of accountability. DCP-D is patently different! Below is a partial-itemized listing of common skin-lesions (primary morphologies) that DCP-D is Turn-Key Ready to safely terminate.
Indications of Use (Commonly Treated in General Practice):
DCP-D (ADV-01) also treats stratum corneum epidermidis, and miscellaneous solid tumors (per otoscope speculum cryotherapy). Having the added benefit of a proprietary Level-2 Halo-Deck Banded-MIT Corona. Tiered-Band is thicker. Useful as a biologic isolate; further adding to the speculum otoscope 2.0 funnel-method for more accurate triage procedure. Adroit for device lite-weighting. A design paradigm supported by STEAM technology. FDA EUA; SARS-CoV-2. Pandemic-Deployment Compliant (P-DC).
Providing a verifiable and repeatable mixed-reality methodology; holographic AI shielding for non-effected virgin tissue during “flash-freeze” Stage-2. Preventing cosmetic collateral damage.
Achieving HD performance commensurate to board-certified LMIs, MDs, NPPs, conscripts and OTC DIY practitioners. Along with zoological veterinaries and early-adopters will greatly benefit from this “Copilot 360° health tech revolution.” Substituting-in and favoring a Discrete Cryosurgical Primary-Device. As it reevaluates the current gaggle of antiquated, copy-cat, medieval gadgets that are embedded (and senselessly linger) in this cottage industry. Predicate prior art has a tendency to disparage physician reputations during a pandemic. Where patients miss-out on daring Elective Surgery procedures, and humanity itself is unfairly held-back from holistic living.
Referring to specification figures, images clearly delineates the nomenclature of DCP-D (with respect to FDA Regs. 37 CFR 1):
[DISCLAIMER: Throughout specification of DCP-D, the 3D Level-2 Halo-Deck Wand-base (8) is hand-carried. A mobile, reflexive, bendable, sled-like tool for cryotherapy. An artisan-styled, digital decoded-encoded, Human-Factor (HF) chassis-platform. Enumerated-in svelte “bucchero” human and military terms. Distal-Head, Broad-Shoulder, Hip and Tail, Backbone-SRS segments offers a 360° continuous, circumferential open-halo outer perimeter feature. Chamfered and beveled-edges for insertion into tight, hard-to-reach areas. Bilateral, aperture metered-socket protocol-keys are a subset to said MIT Level-2 terraced band. Circumferential with respect to Reflex-Wand. A digitally encoded-filter membrane that shape-shifts a lesion, thru a “decoded” IMP socket-key filter. IMP protocol-key (socket-fixtures) execute a “choke-suppressor” function. Furthermore, Arcuate Bowl (10) of flexible, on-axes, 3D Kinetic Exoframe Wand has substantial lite-weighting; agile, rigid, gimbaled, anatomic bio-recognition auto-lock; CACHE-IN-AOD capture-feature over lesions/tumors/etc. Self-indexing aperture metered-socket protocol-keys provide Close-Quarter-Hold (CQH), Tourniquet-Capture throughout the 3D Halo-Deck Band. Spec-Ops-7 “munition IMP cluster-keys” (15) provide fine-tuning capture for 1:1, 2:1, 3:1 triage. Florentine apertures further extend user-reach of tool. Select IMPs contain gradient-sized Star-Ratio Patterns. IMPs are positive gain-of-function (termination) assets; funnel-chokes with undercuts, operating under “a Braille-effect” feedback loop. Combined, proprietary IMP's enhance protocol-portals to produce an integrated First-Responder-Asset as a “Mobile Strike Group” device; utilizing Rapid Defense-Rapid Offense Procedures™ (RD-ROP). Under-Body Backbone-SRS is ballast; ballast with rails (surfing-along its slide-polymer frame; facilitating a Just-in-Time (JIT), Frozen-in-Time (FIT); Lesion Harvesting Strategy (LHS). A Top-Sided Stakeholder-Draft Guidance (TS-DG) which teaches “Intel Surveillance Recon” (ISR) best-practices; Web link menu supports stakeholders as a co-pilot. Aka, an “incubator knowledge accelerator” for newbies entering cryotherapy, and seasoned pros still practicing cryosurgery. In all, codifying remittances and reimbursements, backed by Medicare/Medicaid [CMS.gov.].
Under-Body (9) of 3D Wand-base (8) exposes central Backbone-SRS (26). A tool with a backbone for shared-mobility, quick-triage; controlled-gliding, pitch/twist, gimbal. Under-Body Backbone-SRS-prevents snags. Improved triage results. Not shown is a Under-Body Edge-Glide-Rails (21) in pivotal areas. Allowing user to control the glide-slope; in multi-directional gyrations (straight/linear, crab-walk, cross-thread, moon-walk motions). Useful during surveying Stage-1 exams, diagnostics. Snapping-turns, 360° rotations; circling-back for retreatments.
In the spirit of reciprocity and reconciliation, tool serves the public-good by democratizing quality-cryotherapy. Level-2 Halo-Deck Banded-MIT-Corona (11 a/b) provides Wand with a thicker/deeper Wand funnel aperture-socket, within the Level-2 MIT halo-band matrix. Deeper aperture facilitates a longer cryogen penetration-cycle over sensitive lesions, while reducing circle-back sorties and costly patient-revisits (CAPA-oriented). Level-2 MIT (with subset IMPs) represents “a thicker-banded area around an IMP Halo band-deck” of Wand. IMP aperture-sockets are integral and adaptable-components. Scaled-models that require forethought and skill by the user. Tilted and rolled Close Quarter Hold (CQH), thanks to a Backbone-SRS central-glide point. Whereas the Under-Body Glide-Rails (16) provide lift, probe and linear stability. Preventing skin-fold slippage. IMP's lesion-size variable. Holding a clinical range of CQH, able to auto-lock, self-index over cauliflower, malformed lesions. Gravity-defying, floating-ballast. High flexible downforce allows device to achieve the proper attitude and point-of-contact with ambient temperatures. It's a question of balance; dexterity-fidelity-efficiency. Providing a unique 24/7 clinical bump-feedback loop. A Bisecting Mid-Ridge Groove (32) substantially surrounds perimeter of Wand-base (8). Under-Body Backbone-SRS (26) eases maneuvers during Stage-1 lesion sorties.
Moreover, SRS acts as a Snag Reduction System, allowing smooth gliding (skin surfing) without the risk of cutting hair, fleshy-tissues. Policing the zone for suspect lesions. Floating like a butterfly; having an “Airbnb-quality” with SecureFIT, auto-lock mitigation strategy. Hence, Glide-by-Wire™. A precise glide-slope for HD patient-care. Under-Body Edge-Glide-Rails, like rudders on a boat, guides tool where it needs to go; prying-open skin-folds (strategic leverage). A tactical operation; picking-off small nagging lesions one at a time. Aiding in users panoramic, 360° and quick-site picture. CAPA compliance. DCP-D provides a precise 100:1 kill-ratio. Multitasking Assets on Demand (CACHE-IN-AOD). Skeletal-Girder Reflex Exoframe Wand was bioengineered for Offensive-Defensive systems. Navigating and sliding the skeletal chassis ever-so-gently. Patrolling, gliding the visible epidermis. Surveying, probing, always on the look-out for suspect tissues. Intervention, capture and evisceration of unauthorized bodies. Diffusing tensions between healthcare providers, and innocent patients.
Topside Level-2 Halo-Deck Banded-Corona (11a, 11b);
In short, Wand-base (8) and Level-2 Halo-Band (11a, 11b) extends cryogen penetration deeper for a “leave no lesion behind” level of care. IMP aperture-keys are permanent, molded-in (not added-on nor constituent parts). Entire skeletal Exoframe Wand-base (8) is completely devoid of “FDA Constituent Parts.” An important distinction to make, since nothing can break-off, shred or injure a patient during simple, out-patient triage or cryosurgical procedures. Rigid, flexible, 3D Halo-Deck Wand-base chassis (8) is resilient. Having a substantially profiled terrace surface finish; compatible for an “Rx label cover” (ISO 15223-1:2021 compliant). An integral strategy for FDA stewards.
[
[
[
[
[
[
Close-up view shows individual Spec-Ops-7 cluster-keys (15). “Numbered & Nesting Apertures” at tip & neck-segment close to the Wand's center-line. Spec-Ops-7 cluster is a tactical AI/AR feature. Useful during sensitive triage on: the face, eye-lids, eye-sockets, genitals, etc. Maximizing a 360° Lesion Masked-Mandate Rule. A full-suite Spec-Ops-7 gradient (IMP socket-keys) ranging in millimeters as: 2, 3, 4, 5, 6, 7, 8 mm; employing a digital-twin (left/right) decoder as a match-grade MIT toolset. Providing one example of “Interdiction-Consumer-Empowerment” (ICE) protection for patients (a mechanical insurance policy).
(NOTE: As a 360° user-toolbox, Skeletal-Girder Reflex Exoframe is heavily engineered, yet lite-weighted. A skills-based, technician's tool using familiar, svelte, human-like features under wartime terminology. In
IMP-sockets are clinically bio-engineered to probe/navigate, intercept and auto-lock (ShureFit) on to a wide-range of epithelial morphologies with impunity. ShureFit “decodes and transforms” a lesion to a corresponding aperture socket-key, for an accurate, leak-proof clinical-fit. STEAM-designed for: 360° probing between toes, inside the naval, behind ears, skin-folds and other “parts unknown.” Cherry-red angiomas and challenging, hard to reach eyelid canthus tags notwithstanding.
Whether the end-user is a board-certified physician, an NPP home healthcare provider, conscript or self-treating DIY patient. SOP's for Stages 1 and 2 still apply. Where top-side label provides a web-based guidance resource to learn best practices.
3-Stage Method of Use: How does DCP-D Interface for Cryosurgery?
STAGE-1 End-to-end asymmetrical triage (one-hand needed). User/physician will glide Wand-Base (8) carefully over the epidermis; evaluating & scrutinizing suspect growths on-the-go. Monitoring, examining common skin lesions “ID-foreplay with glide-rail feedback.” Key match-ups; surfing the epidermis “ISO a mate.” Squeezing lesions into an IMP (auto-lock). Up-close and personal. IMPs provide a unique, over-the-top HD site picture. Whereas, Backbone-SRS will bump into everything protruding.
German-engineering, made in the USA; allows for a “mix-and-match auto-lock test-fit method” where user applies a measured downforce of pressure. A basic-tenant that traps and seals pre-selected lesions (or lesion cluster) “inside a box”. Allowing user to determine: phenotype, size, color and histology. Isolating a lesion; coming-in tight on-entry. Capturing and holding it inside an IMP socket in a snug, pre-ablation manner. Providing a Zero-G micro-gravity XYZ capture; within striking-distance to deliver LN2 ordinance. A holding-pattern. Sheltered-in-place. Targeted. Conforming to biomimicry socket protocols; all of this forms the basis of key-matchups. Pre-stage complete.
STAGE-2: Pre-staged, interfaced; everything's locked and loaded. User/caregiver now applies any number of qualifying cryogenic means; I.e. Q-tip soaked in LN2, a cryoprobe (CRYO2), cryopen, a Freon-sprayer; nitrous oxide pressurized gas means, etc. A judiciously applied “combination biologic” interacts.
A friendly gain-of-function occurs “in the drop-zone” aperture-socket key. Providing a commanding view of lesions, sheltered-in-place. Now it's time to pour-on the coals. Stage-2 requires all-hands-on-deck or an assistant administering cryogen means, as Wand-base tool-handler holds DCP-D steady (if necessary). Most providers can perform triage single-handedly. E20-11 (Easy to Operate-11). Patient and provider both are anticipating the cold-fusion, kill-shot.
With said lesion(s) snugly-isolated inside a pre-selected IMP socket, this marks the one-two stage process of ablation. Consummating the interface procedure: triple-aim, work flow optimized, physician extender, Stage-1 set-up. Worth noting, Spec-Ops-7 IMP cluster-keys (15) are carefully spaced-apart to optimize dexterity, triage placement, virgin tissue masking in order that the stakeholder can make tactical, surgical cryogen strikes, without overfilling the socket, or inadvertently administering collateral damage to surrounding virgin (unaffected) tissue(s). Mission specific, Spec-Op-7/I-OPS keys achieves a high-definition of granular dexterity/discretion. Intended for high-risk areas: face, eye-sockets and private-parts. Expertly used under LN2 timed-pooling procedures. As a tool, DCP-D sticks-the-landing as a Dermatological Pocket-Sherpa. Employing the use of Intel-Surveillance Reconnaissance (ISR) found in the DCP-D Draft Guidance. Thus, a custodian reflex-wand performing triage, backed by a Regulatory Pathway Assessment (RPA), and the ABC's how to perform triage properly.
STAGE-3 Lesion Mitigation Strategy: 2 Bio-Mechanical+1 Natural
Stage-3 is the result of proper alignment, execution and skills based application at Stages 1 and 2. Whereby tissue from normal individuals, will undergo a “regeneration process.”
The ability of skin to heal; re-epithelization of partial thickness burns. Ensured by keratinocyte migration from skin dermal appendages; which begins within a few hours of the cryodestruction. Moreover, the regulatory basis for Stage-3 Blitz-Krieg regeneration cannot be overstated. Clinical accuracy, achieves the DCP-D end-game hypothesis. Significantly eliminating user-error (under strict protocol conditions per ISR Draft-Guidance; ADA/AMA guidelines). Any “mistake” in this area can be costly, injurious, blinding or worse. Save for our ingenious, safe, pin-point, bio-cryoshield design (compliant to FDA/CDRH industry best-practices).
In the event of a Stage-2 accidental LN2 spill, DCP-D uses a CAPA inspired “safety-gantry half-pipe flick-escape procedure.” A rolling-wave design method (per Krieger-Amulet-TaaS™) DCP-D is able to ferry-away an accidental liquid LN2-spill.
This is done by flicking Wand chassis, away from the patient in an instant! Marking device as a user-friendly, CAPA-capable, compassionate first responder. BTW: red-cherry-angiomas are a “specialty” of Spec-Ops-7 IMP cluster-keys (15) with respect not only to angiomas, but also to multitudes of small and large skin-morphologies, etc. Also known as “senile angiomas” and “Campbell de Morgan spots,” red-cherry angioma sized growths were specifically factored-in to the DCP-D Spec-Ops-7 model.
Decisive, capable; “armed to the teeth” with a wide-range of spatially-acclimated IMP socket-keys; ADV-01 creates access into tight-areas. Resulting in a 100% kill-ratio surgical strike. Astute. Uncompromising accuracy. A forward deployed, daisy-chain orientation; preventing collateral damage. That's the drill.
Furthermore, Halo-corona (gaps) are integral, specialized in their own right. Performing a chameleon-quality, DCP-D halo-coronas are bespoke Spec-Ops-7, I-OPS containment sites. A fine-tuning “triage by-the-numbers” approach. Spec-Ops-7 Cluster (15) creates a tight “myopic bubble” to encapsulate. Isolating, guarding lesions inside each metered IMP socket-key perimeter. Handled tactfully, DCP-D guarantees outside virgin tissue is safely protected (inside the bubble) from harsh biologic leaks or cryoprobe slip-ups. Especially useful if an LN2 spill occurs. Preplanning, point-of-attack, execution and withdrawal is one asymmetric, CAPA strategy built-into DCP-D device. A family medicine and mobile-mercenary-approach, providing a “lesion death-trap.” Overcoming numerous limitations, user error(s) and blind-spot failures of prior/predicate art. Thus, DCP-D achieves purposeful ambient temperatures at point of contact, safely. Compliant to: design inputs, outputs, verification; validation.
[
Tail-Edge Open Halos (25) are perimeter fixtures located at the “proximal-most, out-edge space” of Wand-Base tail section, and within the Level-2 band. However, Tail-Edge Open Halos (25) are not “locked closed” (versus “open” IMP) halo-corona-gaps. Again, Tail-Edge Open Halos (25) are Open! Open chamfered/beveled. Hybrid, on-demand tooling. Intended to be pushed-up against a lesion (in dark-tight-sweaty, hard-to-reach areas). The entire circumferential outer edge of Wand (8) is beveled, chamfered, and may well be used as a hybrid, unlocked open-halo as needed. Whereas, interior Tail-Bowl IMP Halos (23) are pitch, yaw, tilt, gimbal, twist and roll-centric. All are 3D-control surfaces. Self-indexing, like puzzle-pieces to facilitate AI/AR triage. Furthermore, up-bent Tail Section (24) facilitates unique tactical access. Advantageous for targeting sensitive areas in the groin; skin-folds, toes, etc.; emblematic of Exoframe Wand.
FYI: Predicate/prior art challengers all fail to make provisions for: a Level-2 terrace band, halo-corona-gaps, spatial acclimation Spec-Ops-7. No prior art can offer the deep-bench of proprietary assets, or Cache of Intelligent Novel Assets-On-Demand (CACHE-IN-AOD) nor strategic key-matchups, as those baked-into the DCP-D. Prior art is “Limited and Deficient.”
From a CAPA point-of-view, predicate devices are also limited with respect to: Broad-Shoulder Wing Segment (16); Under-Body Backbone-SRS (26); Under-Body Edge-Glide-Rails (21). AWOL when it comes to DCP-D's CACHE-IN-AOD toolset. The depot of pay-it forward DCP-D amenities (replete with 24/7 standby assets).
[
In addition (as alluded to earlier); Florentine apertures (29a/29b) is a hybrid variant of IMP protocol-socket-keys. Notice Florentine-styled elongated aperture (29) a/b. This is a proprietary, multi-fit “unlimited-class IMP pairing”. Florentine (29) a/b is considered a work-around at “scripted and unscripted CQH;” striking-a-chord where standard IMPs may be insufficient. A mechanical-hybrid work-around tackles dysmorphic-shaped tissue where other IMP's cannot adequately negotiate. A menagerie of unique, well-positioned IMP-socket-keys are replete in Wand (8).
For the record, (8) divisional, derivative iterations of DCP-D exist; including: a). ADV-01, ADV-02, ADV-03; and b). VA-01,02,03,04,05. Where “VA” is for veterinary, derivative uses).
[
Mid-Ridge Groove creates not one, but two sure-grip, horizontal, circumferential edges for a positive, non-slip grip. Confident, surgical control through latex gloves (ADA/AMA Rx recommended). A medical-device version of AI (driver-assist). Control. Hand eye surgical precision, substantially reducing Stage-2 errors.
Mid-ridge groove does not interface with Backbone-SRS (26). To that end, Backbone-SRS (26) facilitates surfing, gliding hovering; creating a weightless Zero-G micro-gravity XYZ-axes advantage. A “super-cruise ballast effect.” Light-weighting the glide-slope process while providing a Snag-Reduction-System (SRS). Used in combination with Under-Body Edge-Glide-Rails (21), allowing DCP-D to probe deep-down into skin-folds. Discretely treating a frontier of patient private-parts (with confidence, honor). Providing stakeholders with a “joint-vertical, take-off and landing Braille-effect Med Tech connectivity.” Proprietary. Non-obvious. Uncompromising.
[
[
A careful spray-over application of a “pressurized cryogen” should be administered at 90° and 1.5 cm above target lesion. Multiple-strikes may be repeated to achieve a desired outcome.
In real-time, provider determines if circling-back for retreatments is prudent or not. This “prior planning approach” commonly eliminates most nagging lesions from regrowth (as a recurring threat). A process referred to as Krieger-Amulet-TaaS℠ (KAT) method. Reducing unforced errors, retreatments and costs.
[
A full-cycle of DCP-D triage is on display. Wand-base (8) is shown as a horizontal, cross-section (despite the fact that Wand is substantially % pipe, arcuate.
[
In [
Tactical, purpose-built, patient-centric; each Halo-Corona-Gap “holds the cryogen charge in-place.” On-point, with the lesion encased in a socket, able to maintain this Close-Quarter-Hold (CQH) is necessary to effectuate a 100% deep-dive hole-shot. Whether or not the particular lesion requires to be re-touched.
Prolonged stewing of LN2 produces superior end-results, allowing continued deep-dive penetration for 100% ablation. Causing fewer patient return visits, higher patient-triage satisfaction; and favorable provider reporting/scrutiny at social-media outlets.
An ICE-Offensive (hard-freeze) is in-play. Decisive-blow to morphologies. Concentrating, intensifying and multiplying the cryogenic-effect and destructive necrosis cycle is the purpose of Level-2 MIT band. Integration and pin-point accuracy. DPC-D high definition (HD) triage results. Spatially acclimated, this level of accuracy, marks a “clinical check-mate.” A mission accomplished moment. Accuracy always requires a caring, studied, observant, and steady-hand. As an aside, AI/AR 3D engineering, virtually eliminates “interstitial-gaps” between IMP-key and lesion. “No leaks equals no skip-shot. Quality triage means no malpractice litigation. No patient complaints or incriminating open-mike moments by disgruntled patients in social-media.” Tidy and clean triage equals patient equity. Creating traceability, accountability, with lower E/M “provenance-costs” to insurers. Serving as a “lesion-cleansing eradication campaign.”
[NOTE: During Stage-2 of triage, LN2 will “briefly freeze-stick” to the IMP halo-corona-gap. In the pocket (the drop-zone). Unique and specialized, tiered halos flash-freeze lesion-to-wand. Creating a high-definition, sheltered-in place, hole-shot execution. Should a provider have doubts of best practices; prudence demands seeking-out: professional-care, TS-DG/ISR, and clinical wisdom/experience BEFORE attempting triage procedures.
As a whole, all illustrations make the case: Stage-1 and Stage-2 must be performed accurately a.) According to ADA/AMA recommended clinical guidelines; and b.) In concert with Topside Stakeholder-Draft Guidance (TS-DG) Web link (provided on DCP-D's topside cover-label. Healthcare stewardship without spilling a drop (or breaking a sweat) where the only things dying are nasty lesions (and archaic bad-habits). Providing stakeholders with quick-draw, time-to-value, Key Performance Indicators (KPI's). With many fronts in this war, DCP-D seeks to “right the ship.”
Metered-Cryogen-Regulated+LN2 Spill-Shield CAPA Compliance
Doubling as a MIT platform, and a large reservoir/shield (11a, 11b). In an extreme emergency, if LN2 is accidentally spilled onto the Wand or patient during Stage-2; the cupping, arcuate, sled-shape of DCP-D Wand-base (8) serves “as an emergency elongated-capture-wand and gantry flick-ejector.” Protecting all parties; like a “burly baseball-catcher, guarding home-plate.”
Timed-Spot Freeze-Ejector-Port Technique+Jules-Thompson Method
ADA endorsed, DCP-D was designed around a co-witness surgical tourniquet. This accounts for: an optimum, metered dose of an LN2 biologic, applied to a specific lesion phenotype/size; administered through a pre-selected Matrix Metered Socket Protocol-key (aperture compensator). Direct, cross-threaded, auto-lock (ShureFit) preparation for a strategic, tactical; clean-biologic operation. Prepositioned, a cryogen is ADA-applied directly over-top; creating an ice-field. Properly done, this method will fully necrate the blood-stalk life-line; per AI Detail Enhancement (AIDE); limiting most re-visit/retreatments. Having a deep-bench, the AI/AR “mask-mandate of DCP-D” achieves FDA/CDRH regulations, and provider remittances (CMS.gov).
To some degree, each tourniquet-capture and choke-hold method results in the same standard of care. Personalized, 1-to-1 equity-inclusion-healthcare model. Freeze-exposure time frames are adjusted according to: skin-thickness, vascularity, tissue-phenotype, size, lesion morbidity, skin-folds, histology, etc. Maximum control, with minimum separation. Ablation with a proportionate, metered-pace without collateral damage. Lesion masked-mandate and border-wall paradigm for cryoablation, cryotreatment, cryosurgery, necrosis.
As a long-time triage out-patient, inventor is merely channeling his own (as well as other) frustrated, injured and marginalized patients. And so, inventor has painstakingly attempted to carefully delineate exactly how DCP-D functions as an Epidermal Lesion Removal Triage System. DCP-D measures a substantial length, width and thickness (per divisional/derivative and variant best practices). A disruptive, Med Tech device. Novel. Unobvious. No scarring. No excuses. No social-media open-mic moments. Ethical. Convenient pocket custodian on-a-stick. Human-Pocket Sherpa Form Factor (H-PSFF); performance triage achieving necrosis via Pressurized-Kinetic-Forces. Rx indications of Use.
A cache of resourceful amenities. A forward-deployed, mobile family medicine tool. Totally Off-the-Grid (OTG) having balance, ballast, a unique 3D XYZ axes. Broad-shoulders with a backbone. Courting and culling most skin lesions, on-demand. Full stop.
DCP-D Requires 3-Stages for Cryotherapy Recuperation
once a lesion is found, the user has the opportunity (and Wand-based means) to measure, research phenotype; ascertain size and profile. Monitoring TS-DG assessments BEFORE proceeding with (or attempting) a “live cryosurgery/cryotherapy procedure.” Affording stakeholder every opportunity to gain medical advice in advance. Informed consent decisions, pre-screen surgery etc.; allowing all parties to invoke prudent medical pre-evaluations.
STAGE-1: Pre-Ablation; Shelter-in-Place/Survey Protocol. A targeted-acquisition (hide-and-seek) of a lesion/morphology is structured; clinical protocol (per ADA/AMA cryodestruction methodology). Lesion Screening-Identification (LS-ID). Where stakeholder (MD, Rx physician, NPP, healthcare provider or DIY home-user) squeezes Wand down-over-against a specific lesion (or cluster of lesions) inside the Cryogenic Landing-Zone (CL-Z). Forming an encoded “suppressor filter seal as a second-skin” interface between lesion and device (AKA pre-ablation staging).
STAGE-2: Gain-of-function; asymmetrical necration. Interface Ablation Sequence (IAS) begins. IAS is the actual application of a cryogen. Liquid Nitrogen Q-tip suave is preferred. In one example, when Liquid Nitrogen (LN2) is used with a lengthy Q-tip or similar applicator); the cotton swab tip is immediately pressed against a lesion. At −319° F., LN2 is tricky and may pose a serious and/or dangerous risk if mishandled or spilled. Expanding LN2 evaporates immediately at room temperature (from a vented Dewar or properly modified stainless-steel thermos).
During cryodestruction the user: co-witnesses, monitors and proceeds with the interaction, making real-time calculations and adjustments; determining if circling-back or not to kill blood-stalk. Forward deployed, asymmetric-guerilla-warfare on single (or multiple) lesion-cluster is de rigueur. Battle-ready per tactical/skillful use of Spec-Ops-7/I-OPS. CMS.gov reimbursement compliant. Platform-ready to triage scores of lesions per visit.
STAGE-3: Marks a natural, regenerative-healing process performed by the body (for most normal humans). A de rigueur cycle that leads harmoniously toward a copacetic, holistic resting-state.
IMP Metered Socket Protocol-Keys (Aperture Compensators) Perform Four (4) Critical Functions:
1. “Over-flow capture of an LN2;” sustaining the formidable cryogenic charge “just a little bit longer” as it's working its “thermobaric bunker-busting magic” over the lesion.
2. Providing a “safety-net” (safety-gantry function); a Wand length reservoir of cryogen allows for sustained procurement of any small and errant “over application” of LN2 (should that accidentally occur) during Stage-2. Correctly administered, a structured/predictable snow-cone effect occurs.
3. Lesion will temporarily freeze-stick (clinical cold-fusion) to the IMP socket-key aperture; holding it in place (tourniquet-effect) under the scorching, penetrating, punishing pressurized forces of a cryogen charge. During which time the user holds-steady, making observations. Attentive and prepared to pivot or abort triage fast! Acting holistically on behalf of the patient.
4. A “cryo-firewall stand-in.” A patient-safety mechanical barrier. A careful “bubble-defense isolate” surrounds lesion.
Protecting, shielding adjoining unaffected tissues, from skip-shot collateral damage. DCP-D may also be used along-side: homeopathic salves, topical salicylic acid, cauterization; topical brush-on chemo skin-peeling (other ADA approved means). In substance, device material(s) were “biocompatibility tested” to ISO 10993-1:2009; medical-grade blending's enabling: reflex, 3D miniaturization, IMP-mosaic socket-keys, under-cuts, surfing and crawling, coloration and repeated use. Metered delivery systems. Tight, circumferential borders with no premature easing of restrictions at the margins. Entire 360° circumferential edging of Wand is an open-halo for triage. A Rapid Defense-Rapid Offense Procedures™ (RD-ROP); safe as a Pandemic Deployment Compliant℠ device and family medicine tool. Mission specific sorties, triage and special operations for disaster relief. A panacea addressing safety, security assistance and security guarantees for stakeholders and patients. De-risking the stress. Damage-control from the brutal mechanisms of prior art follies.
A one-handed, asymmetric, strike-force on-a-stick. A physician extender for Licensed Medical Intermediaries (LMIs), NPPs and DIY home-converts. Aspirational. Setting a new standard-of-care in triage cryosurgery. It is advised that stakeholders using DCP-D, first seek medical training, certification(s) from an attending physician and Stakeholder-Draft Guidance (S-DG) Web link PRIOR to administering cryotreatment/cryodestruction.
[NOTE: Inventor/sponsor advises that users and caregivers review and follow all training and regulatory standards/certifications. I-Ops Munition IMP socket-keys (15), and the proper use of the Spec-Ops-7/I-OPS; pin-point triage by the numbers. Allowing for fidelity, discretion as a Level-2, pocket-Sherpa, form-factor. Single-action, center-fired, aperture-suppressor. A full suite as a clinical, plug-and-play, physician extender. Timed-spot operation using socket-keys per “freezer-locking breach.” One-and-done triage neutralizing epithelial lesion outgrowths. DCP-D (ADV-01) is considered an “Equal-Opportunity, Assistive Copilot during a cold-war renaissance of HD patientcare.” Intervention using Interdiction Consumer Empowerment (ICE), avoiding injury, malpractice and blood-letting conflicts. Bringing to bear novel, bespoke, gravitational and pressurized kinetic-forces; without use of electricity, constituent parts, or 3rd party calibration.
Asymmetrical, hand-held. DCP-D is an all-in-one, Tissue Defense System 101. Pared with a 3d party biologic, effective as a: “bilateral, Andro-Synchronous, Level-2, Skeletal-Girder Reflex Exoframe tool.” Performing triage in high-definition (HD). Surveying and performing epithelial examinations copilot (TS-DG) training for stakeholders. Deliverables are indicated to improve doctor performance review by eliminating misguided injuries, shaky-hand foibles; skin-burning misadventures. Safe and sobering outpatient triage for all patients, both young and old.
[DISCLAIMER: DCP-D (ADV-01) aspires to support and reinforce a go-to leadership role for in and out of network clinics. Eliminating the obstacles and inefficiencies of embedded predicates (prior art). DCP-D meets Federal Drug Administration (FDA) 21 CFR instrument for general use (Class-1 General Controls). Applicant-inventor claims and specification disclosures are intended to achieve: USPTO statutory enablement provision 35 USC S 112(1)/(a); post AIA. Filed as an NGO.
35 USC 112 (1)/(a): “The specification shall contain a written description of the Invention, and of the manner and process of making and using it, in such full, clear, and concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the Best Mode contemplated by the inventor or joint inventor of carrying out the invention.” DCP-D cryotherapy; TaaS methodology safely executes its duties in a unique, unambiguous manner. Literally floats upon a Backbone-SRS; guided by underside edge glide-rails allow for a counter-steer functionality. A ground-up performance matrix able to pivot/maneuver unflinchingly. Life-cycle reusable under: UV/IR clinical autoclave; including advanced ETO, Gamma, E-beam, X-ray, NO2 sanitation methods (and the like)].
Moreover, all critiques of prior art devices was based-on objective, printed matters of fact. Spotlighting how aerosolized predicates have “weaponized” chemical-biological agent(s) as unsustainable, stymied and onerous. Many pedicates promote the launch of “fire and forget” (FAF) lethal doses of cryogens. USPTO allows truth-telling without: surmising, malicious disinformation or gas lighting critiques. Welcoming dissenting points-of-view about the pathology of embedded devices in objective, dispassionate terms. As a one size fits all stand-in, many challenger devices exhibit strategic ambiguity. Painfully flawed. Dysfunctional. Evasive accountability. Yet mentioned without trade-libel, false claims or disrespect. Each inventor exercises their own brand of ill-equipped, incompetent, regressive-archaic measures. Inflicting long term harm as their Best Mode devices. But for a side-by-side comparison; 3rd party observers will independently decide if DCP-D/ADV-01 prosthetic, can safely out-perform (out-gun) predicate devices, without capitulating to draconian-standards or nixed triage results.
ADV-01 is a skills-based, plug-and-play, TaaS Med Tech model. Utilizing unique nomenclature. Timed-spot, Freeze-Locked-Breach (FLB) methods, etc. Tightening the triage-circle around unwanted tissue(s). Advanced metered features depopulate singular and lesion clusters; attacking lesion(s) at feeder blood-stalk, per Core Customization triage. Reusable, sustainable, recyclable material (s). Advanced composites; organic/inorganic, thermosets, glass fiber, Additive Manufacturing Compression Molding (AMCM), and Subtractive Manufacturing (SM) methods of development. Top-side label (TS-DG) tutoring via Intel-Surveillance Recon (I-SR). Personal Mobility Device (PMD); mobile lesion processing-unit. Discrete monoframe. Back-fill solution for cryotherapy. A reset for outpatient triage eliminating “off-script, Hail Mary guess-work.” No-fault leadership for: humanitarian crises, disaster relief, MASH; family and emergency medicine. Vociferous advocate for accountability, serving long-suffering patients ISO a safe, authentic, even-handed surgical experience. A practical, handy, reliable, primary-device for LMI's, NPP's, conscripts, home healthcare and arm-chair practitioners. Mercy-Aid Med Tech. Patient-centric translator, producing 3-Stages of Blitz-Krieg epidermal restoration. Industry-wide lesion cleansing campaign for patient-honorees. “As provider sows, a patient will reap” perspective. Triage with CAPA security guarantees built-in. Democratized Humanitarian-Aid on a Stick (HAS). Declassified./RK
(Described in Detail Per Specification DCP-D/ADV-01)
N/A
N/A;
N/A
