Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-09-28
2002-04-09
Mendez, Manuel (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S218000
Reexamination Certificate
active
06368305
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to the field of disposable and nondisposable medical syringes. More specifically, the present invention relates to a means for preventing movement of a disposable syringe plunger element relative to the body of the syringe, whereby the syringe may be pre-loaded with a fluid medicament to a required dosage level, and thereafter conveniently carried in a pocket or handbag without the necessity of carrying a complete medicament injection kit. While the invention is useful in a wide variety of applications, it is particularly suitable for use in conjunction with the administration of medicaments for diabetes, blood thinning, growth hormones, veterinary injections, and the like.
BACKGROUND OF THE INVENTION
Many drugs used to alleviate the symptoms of a number of diseases or medical conditions require frequent injections. The most widely known example of such a disease is diabetes, although also included in this category are diseases and conditions such as juvenile growth hormone deficiency, migraine headaches, arthritis, penile dysfunction, and certain severe allergic reactions. Often these therapeutics are proteins or other molecules, which are not amenable to oral administration.
Diabetes is a disease wherein the body is unable to regulate the transport of glucose from the bloodstream into the cells of the body for use as a cellular fuel. As a result, diabetics often have too much glucose in their blood. The resulting buildup of glucose in the bloodstream can lead to serious health problems, including heart disease, blindness, kidney failure, and lower extremity amputations. It is estimated that about 16 million people in the United States alone suffer from diabetes, which means that one in 20 persons has the disease. About 385,000 people in the United States die each year from the disease, making it the sixth leading cause of death by disease and the seventh leading cause of death overall. The economic cost of diabetes is staggering—the American Diabetes Association estimates that the health cost of diabetes runs between $92 billion and $138 billion annually. One study predicts that the incidence of diabetes worldwide will increase from the current 2.1% to over 3% by the year 2010, resulting in an estimated total of 220 million cases worldwide.
There are several different types of diabetes. Type 1 diabetes results when the pancreas either does not make insulin, or the body destroys the insulin that is made. In Type 2 diabetes, the pancreas makes sufficient amounts of insulin, but the cells cannot use the insulin. Type 1 diabetes is also called “insulin-dependent diabetes mellitus”, because persons with this type of diabetes require insulin shots. Type 1 diabetes is relatively rare, occurring in less than 10% of persons with diabetes. Type 2 diabetes is termed “non-insulin-dependent diabetes mellitus”, because at least initially, the persons with this type of disease do not require insulin shots. However, as many as 40% of the persons with Type 2 diabetes will require insulin shots as their diseage progresses. Type 2 is by far the most common form of diabetes. Over 90% of persons with diabetes have Type 2 diabetes. Other types of diabetes may develop as a result of pregnancy, specific genetic syndromes, surgery, drugs, malnutrition, infections, and other illnesses. These cases account for 1-2% of all diagnosed cases of diabetes.
Diabetes is defined as a medical condition characterized by fasting plasma glucose levels greater than or equal to 126 mg/dl of blood plasma. Diabetics must monitor their blood glucose levels on a regular basis. To maintain their blood glucose within normal bounds, diabetics must combine careful attention to diet, regular exercise, and frequent injections of insulin. If their blood glucose is outside the normal levels, diabetics may experience disabling complications.
Diabetics must carry their own supplies for insulin injections with them when they are not at their home or other location where they can safely store their supplies. These supplies include one or more syringes, sterile swabs, and liquid supplies of insulin. The supplies are either carried loose, or in a kit which includes a casing element. When required, the syringes are removed and loaded with insulin for injection, and the dose is administered. The supplies are relatively bulky and inconvenient, and their use often requires finding a relatively private location having a surface upon which to place the supplies during use. Furthermore, the user must retain at least a portion of the supplies even after the required dose has been injected.
Insulin pens are often used in place of syringes. These devices are prefilled with an insulin cartridge to inject a required dose. The pens are filled with a certain number of doses, and may or may not be ultimately disposable. The pens do not require the user to carry a bulky vial of insulin. However, the pens are not immediately disposable, and like the kit described above must be carried with the user even after the required dose has been injected. The pens are also more expensive than syringes, and the insulin for use with the pens more expensive than the insulin used with syringes. Furthermore, the pens are bulkier than individual syringes. Since needles and insulin cartridges made specifically for the insulin pens must also be purchased and carried by the user, the pens do not solve the problems of having to carry supplies.
Also available are preloaded syringes, from companies such as Vetter Pharma-Turm. However, these syringes are prefilled by the manufacturer, not the user, and the user is not able to adjust the volume of liquid in the syringe without breaking the seal. Furthermore, these devices are locked with a cap on the needle end of the syringe, which means that no needle may be attached to the syringe prior to transport. The needle must be attached to the syringe after the cap is removed, adding an additional step and supplies to the process.
Other references disclose devices and methods for encasing a syringe for safe transport. U.S. Pat. No. 5,519,931 (Reich) discloses a complex device for transporting a syringe filled with a radioactive material. The device includes a sharps container for holding the syringe and a radiopharmaceutical “pig” for holding the sharps container. U.S. Pat. No. 4,886,497 (Scholl, Jr.) discloses a container for transporting hypodermic syringes. The container includes a first sealed position for ensuring that the container has not been tampered with before use of the syringe, and a second position for sealing the syringe after use for transport and disposal of the used syringe. U.S. Pat. No. 4,634,428 (Cuu) teaches a cover for a disposable syringe that allows rotation of the needle after use for rendering the syringe unusable. U.S. Pat. No. 3,937,219 (Karakashian) and U.S. Pat. No. 3,207,302 (Hobbs) disclose methods of packaging syringes prior to use. These methods are typically awkward and not suitable for use with individual syringes.
In addition, much effort has been focused on developing syringes that avoid the problems of accidental needle sticks and illicit re-use of syringes. For example, U.S. Pat. No. 5,891,092 (Castellano) discloses a disposable syringe that provides a slideable protective cover and a disabling member. After an injection is made using the syringe, the disabling member breaks the sealing, diaphragm of the plunger rod, so that the syringe is rendered incapable of delivering another injection. The slideable protective cover also slides forward to cover the needle and prevent accidental needle sticks. U.S. Pat. No. 5,183,466 (Movern) discloses a hypodermic syringe having a plunger assembly that enables the syringe to be used in a conventional manner but not reused. The syringe barrel contains a plunger lock that engages the plunger piston after filling the syringe with a liquid and allows discharge of the liquid, but thereafter locks the plunger in place and prevents refilling of the syringe. U.S. Pat. No. 4,915,692 (Verlier) describes a
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