News Column

Patent Issued for Protector Apparatus

January 29, 2014



By a News Reporter-Staff News Editor at Journal of Engineering -- From Alexandria, Virginia, VerticalNews journalists report that a patent by the inventors Yodfat, Ofer (Maccabim-Reut, IL); Neta, Avraham (Misgav, IL), filed on July 27, 2011, was published online on January 14, 2014.

The patent's assignee for patent number 8628500 is Roche Diagnostics Operations Inc. (Indianapolis, IN).

News editors obtained the following quote from the background information supplied by the inventors: "Continuous subcutaneous delivery of medication or monitoring of a body analyte is often accomplished using a cannula, which remains in the body of a patient for several days. Diabetes patients may use such cannula positioned in a subcutaneous compartment for continuous delivery of insulin effectuated by pumps and/or for monitoring interstitial glucose levels by means of sensors. A combination of a tube, connecting an insulin pump to the cannula and a detachable connector is often referred to as an infusion set. Such infusion sets and modes of their insertion are discussed in, for example, U.S. Pat. Nos. 4,755,173, 5,176,662 and 5,257,980. Subcutaneous cannula insertion modes for continuous glucose monitoring are discussed in, for example, U.S. Pat. Nos. 5,390,671, 5,568,806 and 5,586,553. Usually transcutaneous ('hypodermic') cannula insertion can be carried out with the aid of a sharp metallic 'penetrating member' to be withdrawn after piercing the skin. This procedure can be carried out manually by the patient. The insertion is usually painful and may require considerable skill. Some patients are reluctant or hesitant to pierce their own skin, and therefore achieving proper insertion of the cannula may be difficult. Another hurdle of currently existing methods of manual or automatic cannula insertion is a possibility for unintentional self piercing. Conventional systems have a further problem associated with a need for a proper bio-hazard disposal of the cannula. Such difficulties can be attributable to insufficient patient's manual dexterity or alternatively to his or her anxiety associated with anticipated discomfort as the needle pierces the skin. This problem can be especially significant when an insulin pump is used since misplacement of the cannula can cause kinking along the cannula, incorrect cannula insertion angle or incorrect cannula insertion depth leading eventually to cannula obstruction. As a result of this, delivery of insulin could be hampered causing a life threatening situation.

"In an attempt to cope with this problem, automatic infusion set insertion devices ('inserters') were developed to assure correct placement of a cannula in the body of the patient (i.e., subcutaneous layer), at a correct angle, while minimizing pain and hazardous obstructions associated with cannula insertion. U.S. Pat. Nos. 6,093,172 and 6,830,562 disclose inserters having a spring-loaded plunger for an automatic subcutaneous placement of infusion sets. These automatic inserters can be used with 'pager like' insulin infusion pumps having long tubing and a cannula. However, these devices cannot be used for insertion of a cannula that is employed in skin adherable insulin pumps, which do not employ long external tubing. An example of such device is disclosed in U.S. Pat. No. 6,699,218 to Flaherty et al. In this skin adherable insulin delivery device, the cannula is rigidly connected to the pump's housing. After adhesion of the device to user's skin, the cannula is fired, i.e., it emerges from the device's housing and pierces the skin. Consecutively, the penetrating member is retracted back into the pump's housing.

"One of the disadvantages of this device is that it is relatively bulky, heavy and indiscreet because the spring loaded mechanism is enclosed within the device's housing during the entire period of usage. In addition, the cannula has only one length, and it can penetrate the skin at only a certain angle. Further, the patient cannot adjust these parameters according to various insertion sites and other clinical requirements.

"Continuous glucose monitors are disclosed in U.S. Pat. Nos. 5,390,671 and 6,143,164, assigned to MiniMed and E. Heller & Company, respectively. These devices monitor glucose levels within the subcutaneous compartment by a sensor that is insertable manually or automatically, as discussed in U.S. Pat. No. 7,110,803, assigned to DexCom, in a similar manner as is inserted a cannula for drug delivery.

"In view of the foregoing, it would be desirable to provide improved systems and methods for protecting and concealing needles for use in inserting cannulae and/or sensors into the body of a patient."

As a supplement to the background information on this patent, VerticalNews correspondents also obtained the inventors' summary information for this patent: "Some embodiments of the present invention provide a cannula cartridge unit that contains cannula, penetrating member and protector. The cannula and penetrating member are concealed and guarded by the protector (e.g., a housing). For example, the protector may include an elongate body having a longitudinal axis and a first end configured to mate with a patch secured cutaneously to a human body. During insertion, the cannula and penetrating member are fired from the protector (e.g., along the longitudinal axis). The cannula remains in the body and the penetrating member is retracted back into the protector. Thereafter, the penetrating member and the protector may be discarded.

"The cannula cartridge unit can be loaded into an inserter for precise placement of a cannula within the body of a user. The inserter may be configured for automatic insertion of a cannula that is used with the fluid delivery pump. The pump may be a remote-controlled skin adherable patch type (e.g., a dispensing patch unit) allowing programmed fluid delivery and can include a continuous analyte level monitor. In some embodiments, the delivered fluid is insulin and the monitored analyte is glucose. In some embodiments, the device includes a remote control unit and the following three units: 1. A dispensing patch unit including:

"a. a reusable part containing driving mechanism, printed circuit board ('PCB') and electronics;

"b. a disposable part containing a reservoir, a delivery tube and an outlet port with a connecting lumen; 2. A cradle unit for connecting and re-connecting the dispensing patch unit to the body of the patient. The cradle unit includes a passage (i.e., designed as a 'well') to allow cannula penetration into the skin and an adhesive layer underneath its lower face to allow attachment to the body. 3. A cannula cartridge unit including a cannula, a penetrating member, and a protector. A cannula hub contains a self-sealable rubber septum that can be repeatedly pierced by a connecting lumen provided in the disposable part of the dispensing patch unit.

"System set-up may be accomplished in the following sequence: 1. Reservoir filling 2. Dispensing patch unit is assembled from two parts (disposable and reusable parts); 3. Cradle unit adhesion (in some embodiment this step is carried out after connecting an inserter to the cradle unit) 4. Cannula insertion:

"a. cannula cartridge unit is loaded into an inserter (in some embodiments this step is carried out after the inserter is connected to the cradle unit);

"b. inserter is connected to a cradle unit;

"c. cannula is automatically or manually advanced through the cradle unit towards the body, pierces the skin, penetrates it and resides in the subcutaneous compartment;

"d. penetrating member is automatically or manually withdrawn from the body into the protector and the cannula is rigidly secured at the cradle unit. 5. Dispensing patch unit is connected to the cradle unit such that connecting lumen emerges from the disposable part's outlet port, pierces the cannula hub's rubber septum and maintains fluid communication between the reservoir, delivery tube, cannula and subcutaneous tissue. 6. Fluid delivery is programmed by a remote control unit.

"In some embodiments the cannula delivering a fluid (e.g., insulin) includes a sensor for monitoring a body analyte in the body (e.g., glucose). Fluid delivery can be adjusted according to sensor inputs in a semi- or fully-closed-loop mode. In some embodiments, the dispensing patch unit can include both a cannula for fluid delivery and a sensor for analyte sensing, which can both be inserted into the body.

"In some embodiments, a skin adherable infusion pump ('dispensing patch unit') is provided without tubing, where the dispensing patch unit is configured to be connected and disconnected to and from a cradle unit, and in which a cannula can be inserted through the cradle unit into the body and remain rigidly connected to the cradle unit.

"In some embodiments, a skin adherable analyte monitoring device is provided that is configured to be connected and disconnected to and from a cradle unit. The device is further provided with a sensor that can be inserted through the cradle unit into the body and remain rigidly connected to the cradle unit.

"In other embodiments, a skin adherable infusion pump and analyte monitoring device is provided that can be connected and disconnected to and from a cradle unit. The device employs one dual function cannula/sensor that can be inserted through the cradle unit into the body and remain rigidly connected to the cradle unit.

"Some embodiments of the present invention also provide one or more of the following features:

"The cannula can be coupled with a penetrating member to facilitate skin pricking.

"Cannula and penetrating member can be concealed and covered by a protective housing ('protector') to avoid unintentional pricking. The cannula, the penetrating member and the protector will altogether be referred to as a 'cannula cartridge unit'.

"Cannula cartridge unit can be loadable into an automatic insertion means ('inserter').

"Cannula and penetrating member can be fired together into the body by the inserter.

"Penetrating member can be retractable back into protector and then they together will be disposed of.

"In some embodiments, a cannula contained within a cannula cartridge unit can be automatically inserted into the body of the patient and can be used for delivery of medication to a patient by a dispensing patch unit.

"In some embodiments, a sensor contained within a cannula cartridge unit is provided that can be suitable for continuous analyte monitoring (i.e., continuous glucose monitoring) and which can be adhered to a patient's skin.

"In still other embodiments, a cannula contained within a cannula cartridge unit is provided that can be precisely aligned relative to a cradle unit and which can be rigidly connected to the cradle unit after insertion.

"In some embodiments, the present invention provides a cannula contained within a cannula cartridge unit that can be used in connection with a skin adherable pump. In some embodiments, the present invention relates to a method for automatically inserting the cannula.

"In some embodiments, the present invention provides a sensor contained within a cannula cartridge unit that can be used in connection with a skin adherable continuous analyte monitoring means. In some embodiments, the present invention relates to a method for automatically inserting the sensor.

"Some embodiments of the present invention provide a cannula and a sensor contained within a cannula cartridge unit that is intended for use in association with a skin adherable pump having analyte sensing and fluid dispensing capabilities, where the fluid dispensing can be adjusted according to analyte sensing in a semi- or a fully-closed-loop mode.

"In some embodiments, the present invention relates to a method for automatically inserting the cannula and the sensor, where the cannula is used for the insulin delivery and the sensor is used for continuously monitoring the glucose levels.

"In some embodiments, the invention provides a cannula cartridge unit that can be loaded into an inserter and can be easily unloaded from the inserter. In some embodiments, the present invention provides a cannula cartridge unit that can be easily handled and has a griping mean for inserter loading and unloading.

"Some embodiments of the present invention relate to a cannula or a sensor contained within a cannula cartridge unit and a method for automatically inserting the cannula or the sensor into the body of the user.

"In some embodiments, the present invention provides a cannula cartridge unit loaded into an inserter that can automatically insert the cannula into the body of the user, where the retraction of the penetrating member can be performed manually.

"In some embodiments, the inserter is preloaded with a cannula cartridge unit. After attaching the cradle unit to the skin of the user and connecting the loaded inserter to the cradle unit, the user presses a trigger provided in the inserter. The trigger releases a spring from its loaded position and a dedicated rod which is connected to the spring forcefully pushes the cannula and the penetrating needle out from the protector through the cradle unit's passage (i.e., 'well') towards the body of the user. Consecutively, the penetrating member is manually retracted from the body of the user back into the protector and the cannula hub is rigidly connected to the well. Finally, the inserter is removed from the cradle unit and the protector (with the penetrating member inside) is unloaded and disposed of.

"In some embodiments, the inserter is preloaded with the cannula cartridge unit and the cradle unit. After spring loading, the user attaches the cradle unit to the skin and pushes a release button. Insertion of the cannula and the penetrating member into the body and retraction of the penetrating member therefrom can be carried out automatically using a spring-loaded flywheel.

"In some embodiments, the present invention provides a cannula cartridge unit that can be loaded into an inserter that enables alignment of the cannula with a cradle unit.

"In some embodiments, the present invention provides a cannula cartridge unit that can be loaded into a disposable or reusable inserter. In the disposable inserter configuration, the inserter is preloaded with the cannula cartridge unit and, after insertion of the cannula, the protector (with the penetrating member inside) remains within the inserter's housing and the inserter is then discarded.

"In some embodiments, the present invention provides a cannula cartridge unit that allows cannula insertion at any desired penetration angle.

"In some embodiments, the present invention provides a cannula cartridge unit that allows insertion of a cannula at any desired depth, i.e., the patient can choose the desired cannula length.

"In some embodiments, the present invention provides a cannula cartridge unit that can be directly attached to cradle unit and allows manual insertion. The cannula cartridge unit is attached to the cradle unit's passage ('well') and the cannula and the penetrating member are pushed into the body with the aid of a dedicated rod (or any other similar device). After insertion, the protector is removed from the cradle unit and the penetrating member is manually retracted from the body and is disposed of."

For additional information on this patent, see: Yodfat, Ofer; Neta, Avraham. Protector Apparatus. U.S. Patent Number 8628500, filed July 27, 2011, and published online on January 14, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=69&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=3418&f=G&l=50&co1=AND&d=PTXT&s1=20140114.PD.&OS=ISD/20140114&RS=ISD/20140114

Keywords for this news article include: Proinsulin, Peptide Hormones, Roche Diagnostics Operations Inc.

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Source: Journal of Engineering


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