Patent Application Titled “Diabetic Testing Supply Dispenser” Published Online
By a
No assignee for this patent application has been made.
Reporters obtained the following quote from the background information supplied by the inventors: "The invention pertains to the field of diabetic testing supplies. More particularly, the invention pertains to dispensers for blood glucose test strips and lancets.
"Patients suffering from diabetes are required to perform blood glucose tests on their own blood at regular intervals to ensure that they take oral medication or self-inject with insulin at appropriate times and in proper doses. While specific testing protocols vary, in general they require the patient to draw a small quantity of blood by piercing their skin with a lancet. One end of a disposable, single-use, test strip is then inserted into a blood glucose meter. Having prepared the meter for testing, the free end of the test strip is brought into contact with a drop of the patient's blood drawn with the lancet. Blood is drawn into the test strip, and the glucose meter displays a value correlated to the blood glucose level for that sample.
"According to the
"Lancets have historically been constructed as flat strips of surgical steel with a double edge blade at one end. More recently, single use, disposable, needle lancets have been developed in conjunction with lancing devices that allow the patient to customize the lancet penetration depth. Needle lancets are made available, as with test strips, in bulk quantities (e.g., 100 lancets per package) in conventional product packaging.
"However, these packaging methods have several issues associated with them. Individual test strips are relatively small; for example, approximately 30 mm.times.5 mm.times.1 mm. Loose packing of large numbers of strips in a canister makes it difficult for some patients to isolate and grasp an individual strip from the bulk package, particularly the elderly. As a result, strips may become lost, damaged, dropped and adulterated, or otherwise unusable. Bulk packaging also requires vigilance on the part of the patient to take care when opening the canister, and closing the canister after selecting a strip, to prevent contamination of the remaining strips or spillage of the container, which may also result in losing test strips or damaging them. Opening and closing test strip containers can also be an issue for some patients with compromised motor skills.
"Furthermore, while the canisters currently used to package bulk quantities of test strips are individually relatively inexpensive to manufacture, the sheer quantity of strips used in a large population results in manufacturers making significant expenditures in packaging to supply this demand.
"The cost of diabetic testing supplies is often covered by government subsidized healthcare reimbursement plans, such as
"More importantly, the study pointed out numerous inconsistencies in test strip and lancet insurance claim patterns. These inconsistencies include: patients ordering more test strips than lancets; and patients ordering test strips but no lancets. Further, the study showed that the New York Medicaid program generally provided more test strips to
"In a simple analysis of this study, one can also conclude that significant waste of healthcare funds occurs through simple mismanagement of test strip and lancet ordering, delivery, and dispensing procedures. A more detailed analysis, however, shows that an excess supply of test strips has led to the growth of a 'gray market', with patients offering their excess test strips for sale on the internet to patients who would otherwise pay out-of-pocket from legitimate sources. Test strips obtained intentionally through fraudulent insurance claims may also similarly flow into this gray market.
"As strips are packaged in bulk and therefore relatively untraceable after sale, test strip aggregators have developed that purchase excess strips from patients, re-package them in quantity, and offer them for resale. This practice is undesirable on at least two grounds. First, resale of test strips that have been either legitimately or fraudulently obtained with public funds (e.g., government subsidized insurance claims) results in an unnecessary, and fraudulent, financial burden on those systems. Secondly, as the excess test strips have in many cases been in opened packaging, or even worse repackaged, their integrity cannot be assured. As a result, the gray market contributes to an illegal trade that may also result in delivery of adulterated medical supplies to otherwise unsuspecting patients.
"Similar issues also relate to the bulk packaging of lancets. The temptation for resale of lancets, whether excess lancets acquired legitimately or through fraudulent means, is less than that for test strips. However, the handling of bulk quantities of lancets remains cumbersome, and temptation to re-use lancets contrary to sterile procedure is high."
In addition to obtaining background information on this patent application, VerticalNews editors also obtained the inventor's summary information for this patent application: "Dispensers for diabetic testing supplies include single-use dispenser embodiments and refillable dispenser embodiments. In various embodiments, the dispenser uses an ejector coupled to an actuator external to the dispenser to move single testing supplies contained within the internal volume of the dispenser through a port in the dispenser for selection by the user. These embodiments include, but are not limited to, linear slides with ejectors attached to them, rotating drum ejectors, and cylinders containing individual testing supplies that are rotated into alignment with a dispenser port. In various embodiments, the dispenser has a dispenser head unit that is coupled to one of a variety of magazine designs which store the testing supplies to be dispensed. Some magazine embodiments include, but are not limited to, linear feed magazines, staggered stack magazines, serpentine magazines, and circular, spiral, or helical feed magazines. A bulk loader rapidly refills the dispenser. In some embodiments, testing supplies are affixed to a carrier strip which is carried on a spool internal to the dispenser, incremented out of the dispenser, and cut to dispense a single testing supply during each operation. In some embodiments, tamper resistant elements are added to discourage fraudulent resale of the testing supplies contained in the dispenser. Tamper resistant elements include, but are not limited to, fluid containing ampules that break when attempts to open the dispenser are made, and applicators that apply a marking fluid to each testing supply as it is dispensed. In some embodiments, the dispenser includes a lancing device that is fed by a magazine and deters re-use of lancets.
BRIEF DESCRIPTION OF THE DRAWINGS
"FIG. 1 shows a frontal perspective of a testing supply dispenser for test strips.
"FIG. 2 shows a longitudinal cross-section of the dispenser of FIG. 1 and its internal elements.
"FIG. 3 shows a longitudinal cross-section of the dispenser of FIG. 1 in operation.
"FIG. 4 shows a longitudinal cross-section of the dispenser of FIG. 1 in operation with a test strip in the dispensed position.
"FIG. 5 shows a longitudinal cross-section of the dispenser of FIG. 1 with a slide return spring.
"FIG. 6 shows a longitudinal cross-section of the dispenser of FIG. 1 with a marking fluid reservoir and applicator.
"FIG. 7 shows a frontal perspective of a testing supply dispenser for lancets.
"FIG. 8 shows a longitudinal cross-section of the dispenser of FIG. 7 and its internal elements including a return spring, a marking fluid reservoir, and an applicator.
"FIG. 9 shows a lateral cross-section of the dispenser of FIG. 7 including feed regulators.
"FIG. 10 shows a detailed lateral cross-section of the feed regulators of FIG. 9.
"FIG. 11 shows a longitudinal cross-sectional detail of the feed regulators of FIG. 9 in relation to an ejector and two lancets.
"FIG. 12 shows a lateral cross-section of the dispenser of FIG. 7 having a stacked magazine storage volume.
"FIG. 13 shows a lateral cross-section of the dispenser of FIG. 7 having a stacked magazine storage volume after dispensing of all lancets.
"FIG. 14 shows a lateral cross-section of the dispenser of FIG. 7 having a serpentine magazine storage volume.
"FIG. 15 shows a lateral cross-section of the dispenser of FIG. 7 having a circular magazine storage volume filled with lancets.
"FIG. 16 shows a lateral cross-section of the dispenser of FIG. 7 having a circular magazine storage volume filled with test strips.
"FIG. 17A shows frontal perspective of a rectalinear fracturable ampule containing a fluid.
"FIG. 17B shows frontal perspective of an arcuate fracturable ampule containing a fluid.
"FIG. 17C shows frontal perspective of a trapezoidal fracturable ampule containing a fluid.
"FIG. 18 shows a longitudinal cross-section of the dispenser of FIG. 5 having fracturable ampules containing fluid integrated into the walls of the dispenser.
"FIG. 19 shows a lower perspective of a slide mechanism having a fracturable ampule containing fluid integrated into the slide.
"FIG. 20 shows a longitudinal cross-section of a slide mechanism having a fracturable ampule containing fluid integrated into the slide.
"FIG. 21 shows a longitudinal cross-section of a dispenser of having fracturable ampules containing fluid integrated into the walls and bottom of the dispenser.
"FIG. 22 shows a lateral cross-section of a dispenser having a separable magazine group and dispenser head group.
"FIG. 23 shows a lateral cross-section of the dispenser head group and magazine group of FIG. 22 separated.
"FIG. 24 shows the dispenser of FIG. 14 having a separable magazine group and dispenser head group.
"FIG. 25 shows the dispenser of FIG. 16 having a separable magazine group and dispenser head group.
"FIG. 26 shows the dispenser of FIG. 12 having a separable magazine group and dispenser head group.
"FIG. 27 shows a stack of test strips bound by a removable band.
"FIG. 28 shows a dispenser having magazine volume sears.
"FIG. 29 shows a lateral cross-section of a magazine group having magazine volume sears and head group sear blocks.
"FIG. 30 shows a bound stack of test strips being bulk loaded into a magazine group.
"FIG. 31 shows a bound stack of test strips being held in a magazine by sears.
"FIG. 32 shows the release of magazine sears by connection of a head group.
"FIG. 33 shows a top frontal perspective of a dispenser with a slot allowing passage of a leader attached to a band surrounding a stack of test strips.
"FIG. 34 shows a dispenser bulk loader for testing supplies.
"FIG. 35 shows a dispenser bulk loader for testing supplies filled with test strips.
"FIG. 36 shows a dispenser bulk loader for testing supplies filled with lancets.
"FIG. 37 shows a lateral cross-section of a dispenser bulk loader filled with lancets inserted into a magazine group.
"FIG. 38 shows a lateral cross-section of a dispenser bulk loader inserted into a magazine group loading lancets.
"FIG. 39 shows a lateral cross-section of a dispenser bulk loader inserted into a magazine group when loading lancets is completed.
"FIG. 40 shows a horizontal cross-section of a magazine group having feed regulators and a feed stop mechanism.
"FIG. 41 shows a magazine group filled with lancets and an engaged feed stop mechanism.
"FIG. 42 shows a magazine group after filling with lancets, connection of a head group, and disengagement of a feed stop mechanism.
"FIG. 43 shows a lateral cross-section of a dispenser bulk loader filled with test strips inserted into a magazine group.
"FIG. 44 shows a lateral cross-section of a dispenser bulk loader inserted into a magazine group loading test strips.
"FIG. 45 shows a lateral cross-section of a dispenser bulk loader inserted into a magazine group when loading test strips is completed.
"FIG. 46 shows a horizontal cross-section of a magazine group having feed regulators and a feed stop mechanism.
"FIG. 47 shows a magazine group filled with test strips and an engaged feed stop mechanism.
"FIG. 48 shows a magazine group after filling with test strips, connection of a head group, and disengagement of a feed stop mechanism.
"FIG. 49 shows a dispenser for dispensing lancets and test strips in working pairs.
"FIG. 50 shows a lateral cross-section of the dispenser of FIG. 49.
"FIG. 51 shows a dispenser having a transparent view window and graduations indicating the number of tests supplies remaining in the dispenser.
"FIG. 52 shows a carrier strip to which individual test strips have been affixed.
"FIG. 53 shows a carrier strip to which individual lancets have been affixed.
"FIG. 54 shows a carrier strip to which individual lancets have been affixed forming a bandolier.
"FIG. 55 shows a carrier strip to which lancets and test strips have been affixed in working pairs.
"FIG. 56 shows a carrier strip to which testing supplies have been affixed wound around a dispensing spool.
"FIG. 57 shows a partial cut-away top frontal perspective of a dispenser for testing supplies affixed to a carrier strip.
"FIG. 58 shows a top frontal perspective of a dispenser for testing supplies affixed to a carrier strip.
"FIG. 59 shows a longitudinal cross-sectional detail of a carrier strip cutting blade and actuator.
"FIG. 60 shows a storage receptacle for used lancets and test strips and an intact ampule containing a sterilizing fluid.
"FIG. 61 shows a storage receptacle for used lancets and test strips and a fractured ampule containing a sterilizing fluid.
"FIG. 62 shows a top frontal perspective of a dispenser having a thumb wheel actuator and port adapted to test strips.
"FIG. 63 shows a top frontal perspective of a dispenser having a thumb wheel actuator and port adapted to lancets.
"FIG. 64 shows a cross-section of a dispenser having a thumb wheel actuator and drum ejector adapted to lancets.
"FIG. 65 shows a cross-section of a dispenser having a thumb wheel actuator and drum ejector adapted to test strips.
"FIG. 66 shows a top frontal perspective of a case for a testing supply dispenser.
"FIG. 67 shows a cross-section of a dispenser for testing supplies also having receptacles for used testing supplies.
"FIG. 68 shows a cross-section of a dispenser having a dispenser cylinder.
"FIG. 69 shows a cross-section of a dispenser having a dispenser cylinder head group, a slide actuated ejector, and a magazine group attachment.
"FIG. 70 shows a dispenser with an integrated lancing device.
"FIG. 71A shows a detail of the lancing device of FIG. 70.
"FIG. 71B shows a detail of the port regulator interacting with a lancet during lancing.
"FIG. 71C shows a detail of the port regulator blocking a used lancet from being reinserted into a dispenser.
"FIG. 72 shows the dispenser of FIG. 70 prepared for lancing.
"FIG. 73 shows the dispenser of FIG. 70 after firing the lancing device.
"FIG. 74 shows the dispenser of FIG. 70 after a lancing operation has been completed.
"FIG. 75 shows the dispenser of FIG. 70 dispensing a used lancet and cocking the lancing device."
For more information, see this patent application: Garner-Richards, Steven. Diabetic Testing Supply Dispenser. Filed
Keywords for this news article include: Patents, Diabetes, Proinsulin, Legal Issues, Endocrinology, Peptide Hormones.
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