Milestone's injection technology is based on a patented Dynamic Pressure Sensing® system (DPS®), intended to measure the density of body tissue, and thus help a clinician know the location of a hypodermic needle during an injection. In applications that have already received clearance, the system utilizes computer controlled technology to provide real-time feedback to the medical practitioner and identify with precision when a needle has reached the location where a drug should be administered to a patient. It has the added advantage in other applications of controlling the pain that patients typically associate with injections.
The core technologies and patents covered by Milestone Medical's license were developed by Milestone Scientific in breakthrough dental applications, with more than 50 million injections having been administered to date. Milestone Scientific holds 24 issued patents and has won a number of awards over the past years for its dental products.
Central to Milestone Medical's epidural and intra-articular instruments is the patented CompuFlo® technology for the precise delivery of medicaments. The CompuFlo pressure/force Computer-Controlled Local Anesthetic Delivery (C-CLAD) technology is an advanced, patented and FDA-cleared medical technology for the painless and accurate delivery of drugs, anesthetics and other medicaments into all tissue types, as well as for the aspiration of bodily fluids or previously injected substances. Its regulation and control of flow rate continues to provide the CompuFlo and CompuMed benefits of painless injections, while its Dynamic Pressure Sensing® capability provides visual and audible in-tissue pressure feedback, identifying tissue types to the healthcare provider. This pressure feedback extends the benefit of painlessness from anesthetics with known viscosities to a wide range of liquid drugs and other medicaments with varying viscosities and flow rates. Dynamic Pressure Sensing also allows the healthcare provider to know when certain types of tissues have been penetrated and permits the healthcare provider to inject medicaments precisely at the desired location. Thus, pressure feedback can prevent the suffusion of tissue outside the intended target area, a vitally important characteristic in the injection of chemotherapeutics and other toxic substances.
The CompuFlo technology consists of two critical elements. One element is the ability to determine exit pressure in situ (in the injection site tissue) at the tip of the needle in real time. This minimizes tissue damage (and eliminates the pain of the injection) because the flow rate and pressure of the injection are controlled. The other critical element of the technology is an integrated injection database of algorithms that have been defined which allow for the measurement of the exit pressure. This database of algorithms contains the critical components of specific drugs, parameters of needles, tubing and syringes and all other pertinent components for the safe and efficacious delivery of medications for all procedures.
The CompuFlo technology also consists of a disposable injection handpiece that provides for precise tactile control during the injection, an electromechanical (computer-controlled) fluid delivery instrument and the ability to record data from the injection event. As confirmed by numerous noted medical and dental experts within academia and the clinical practice arenas, CompuFlo has the potential to greatly increase the safety and efficacy of many drug delivery procedures that currently rely upon the over 150-year-old hypodermic syringe technology and the tactile senses and delivery expertise of the administrator.
Negative side effects from the use of traditional hypodermic drug delivery injection syringes include pain, tissue damage, post-operative complications and, rarely, transient or permanent paralysis and death. The pain and tissue damage are a direct result of uncontrolled flow rates and pressures that are created during the administration of drug solutions into human tissue. While several technologies have been capable of controlling flow rate, the ability to accurately and precisely control pressure has been unobtainable until the development of CompuFlo.
Precisely controlling in-tissue pressure increases patient safety by reducing the risk of tissue damage and post-treatment pain related to excessive pressure that may occur during certain injections. Identification of the tissue, in which the needle tip is imbedded, is believed to be highly important in epidural injections and intra-articular injections
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