By a News Reporter-Staff News Editor at Diabetes Week Sanofi-Aventis Deutschland GmbH (Frankfurt am Main, DE) has been issued patent number 9586009, according to news reporting originating out of Alexandria, Virginia, by NewsRx editors (see also Pharmaceutical Companies).
The patent's inventors are Butler, Joseph (Warwickshire, GB); Moore, David (Leicestershire, GB); Draper, Paul Richard (Worcestershire, GB); Gilmore, Stephen Francis (Bristol, GB); Morris, Anthony Paul (Coventry, GB).
This patent was filed on July 12, 2012 and was published online on March 7, 2017.
From the background information supplied by the inventors, news correspondents obtained the following quote: "Pen type drug delivery devices have application where regular injection by persons without formal medical training occurs. This is increasingly common among patients having diabetes where self-treatment enables such patients to conduct effective management of their diabetes.
"For good or perfect glycemic control, the dose of insulin or insulin glargine has to be adjusted for each individual in accordance with a blood glucose level to be achieved. The present invention relates to injectors, for example hand-held injectors, especially pen-type injectors, that is to injectors of the kind that provide for administration by injection of medicinal products from a multidose cartridge. In particular, the present invention relates to such injectors where a user may set the dose.
"A user undertaking self-administration of insulin will commonly need to administer between 1 and 80 International Units."
Supplementing the background information on this patent, NewsRx reporters also obtained the inventors' summary information for this patent: "A first aspect of the invention provides a drug delivery device comprising;
"a cylindrical member configured to be rotatably supported inside the housing, wherein the outer surface of the cylindrical member is provided with at least first and second tracks together forming an encoder, each track comprising conductive segments and non-conductive segments; and
"at least first and second groups of contacts configured to engage the first and second tracks respectively at predetermined intervals along the length of the track.
"The encoder is formed at least of first and second tracks wherein the coding depth of the at least two tracks is combined. Describing the coding depth in numbers of bits, the combined bit depth of the encoder comprising the at least first and second track equals the sum of the individual bit depth of each track. For example, the encoder could have a 7-bit depth comprising a 5-bit depth first track and a 2-bit depth second track. Alternatively, the individual tracks comprise 4-bit and 3-bit depths, respectively, together forming an encoder of 7-bit depth. A 7-bit code that is capable of encoding 2.sup.7 different states is sufficient to encode the positions of an 80 unit medicament pen-type drug delivery device.
"The encoder may be adapted to capture a dose that has been set.
"The tracks may comprise conductive ink printed onto a non-conductive substrate
"The first and second tracks may be separated. The first and second tracks may be separated by a non-conductive strip. The non-conductive strip may be the cylindrical member itself or a secondary substrate which is subsequently attached to the cylindrical member.
"The cylindrical member may be operationally coupled to the dose setting and delivery mechanism, for example by securing the cylindrical member to a dose dial grip and by having a rotatable engagement between the cylindrical member and an inner housing that is connected to a spindle that is driven during dose administration.
"The tracks may be helical tracks and the housing and the cylindrical member may be configured such that the cylindrical member moves in a first axial direction relative to the housing when rotated in a first rotational direction relative to the housing.
"The cylindrical member may be configured to be rotatable from an initial position into a number of discrete rotational positions and the contacts of the first group of contacts may be arranged such that the sequence of conductive and non-conductive segments engaged by the contacts of the first group of contacts in successive discrete rotational positions forms a Gray code.
"The first group of contacts may comprise more contacts than the second group of contacts. The first group of contacts may comprise five contacts and the second group of contacts may comprise two contacts.
"The contacts of the first group of contacts may be spaced such as to engage every sixth segment of the first track and the contacts of the second group of contacts may be spaced such as to engage every twenty-seventh segment of the second track.
"The device may further comprise a switch configured:
"in a first position, to connect electrically the first and second tracks; and
"in a second position, to isolate electrically the first and second tracks.
"The device may further comprise a user actuatable plunger configured to cause expulsion of a drug from the drug delivery device wherein depression of the plunger may cause the switch to switch from the first position to the second position.
"The conductive segments within each of the first and second tracks may be electrically connected to all of the other conductive segments in that track. The conductive segments within each of the first and second tracks may be electrically connected together by first and second common ground tracks immediately adjacent to respective ones of the first and second tracks. The conductive and non-conductive segments of the first and second tracks may be arranged such that, when the cylindrical member is in an initial position, each contact is configured to engage a conductive segment.
"The device may further comprise;
"a display; and
"a processor configured to receive and interpret electrical signals from the contacts, to control application of electrical signals to the contacts and to control the operation of the display.
"The processor may be configured to cause an electrical signal to be applied to at least a first contact of the second group of contacts and simultaneously to monitor signals at at least one other contact in order to determine a position of the cylindrical member. Based at least in part on the monitored signals, the processor may be configured to determine the position of the encoded member. The processor may further be configured to determine the mode of operation.
"The processor may be configured:
"to cause an electrical signal to be applied to a first contact of the second group of contacts and simultaneously to monitor electrical signals at the first group of contacts; and
"if no signals are detected at any of the first group of contacts, to cause an electrical signal to be applied to a second contact of the second group of contacts and simultaneously to monitor electrical signals at the first group of contacts.
"The processor may be responsive to detecting no signals at any of the first group of contacts when an electrical signal is applied to the second contact of the second group of contacts to cause an electrical signal to be applied to a first contact of the first group of contacts and simultaneously to monitor electrical signals at the other contacts of the first group of contacts.
"Another aspect of the invention relates to combining of at least two smaller bit depth single track encoders to create a higher bit depth encoder.
"A standard 7-bit track encoder, e.g., comprises 7 tracks arranged in parallel that require a relatively wide area on an encoded member. Having, for example, the encoder track on a rotating sleeve, a helical version of the encoder would need to fit in the axial pitch, i.e. the space between two windings. According to our example, the 7 parallel tracks would have to fit the space between two windings for a given pitch, wherein the width of each track is very limited. This puts constraints with regards to the individual track width, and construction complexity increases. Fitting 7 parallel tracks in the restricted space results in a high requirement for the read-out accuracy of the encoder with regards to both, the coded tracks as well as the sensors. The length of the tracks depends on the number of positions that are requested to be encoded, e.g. 81 positions for an 80 unit pen, including a zero position.
"An alternative 7-bit single track encoder, e.g., could be adapted to require a width smaller than the standard 7-bit track encoder described before. Instead of having the tracks in parallel, a single track is used where the sensors representing the bits are equally spaced along this track. For an encoder track on a rotating sleeve, a single track could more easily to fit in the axial pitch, i.e. the space between two windings. The encoder may be constructed using a single track gray code, where each column is a cyclic shift of the first column (according to the number of sensors) and from any row to the next row only one bit changes. The spacing of the sensors may be 12, e.g., i.e. a sensor is positioned every 12.sup.th position. When the first sensor is at position '1' the seventh sensor is at position '72'. Having, for example, the encoder track on a rotating sleeve, a helical version of the encoder would require adding the pattern of the single track to the end, because otherwise, the sensors would have no track to read. This means that an extra 72 positions are required to make sure that the seventh sensor or bit 7 maintains engagement with the track. Therefore the solution for a 7-bit single track encoded is 81+72=153 units long compared with 81 units long for the standard 7 track version discussed before. The effect of having a track of relatively small width results in extended total length of the track, compared to the standard 7-bit encoder. A rotating sleeve carrying a single track encoder would consequently have an increased axial size. This could add complexity to the design of the device and eventually could lead to an extended overall delivery device length.
"The above mentioned principles apply to encoders regardless of the number of bits for the encoder track.
"An encoder according to the invention, wherein the at least first and second tracks together forming an encoder, could help mitigating the deficiencies of the two types of encoders mentioned above. An encoder according to the invention requires a width smaller compared to a standard 'parallel-track' encoder. The encoder according to the invention requires a length shorter compared to a 'single track' encoder. Thus the encoder according to the present invention provides an improved encoder that may increase manufacturing quality, reduce cost, and/or increase code efficiency.
"The encoder according to the present invention comprises at least two single track bit-codes, e.g. single track gray codes, together forming an encoder, wherein the encoder has a higher bit depth than each individual track.
"In one example, a combination of a 5-bit track and a 2-bit track together form an encoder of 7-bit depth. The 5-bit track may have a spacing of 6, therefore the 5th sensor or contact is at position 24. The overall track length required for a helical version is 81+24=105. The 2-bit track may have a spacing of 27, therefore the helical track length is 81+27=108.
"The combined encoder having a 7-bit depth comprises two tracks and has a length of 108. Compared to a single track 7-bit code, the length is reduced by approximately 1/3 (compared 153) which reduces the overall size of the encoded member. Compared to a standard 7-bit track, the width is reduced from '7' to '2' which leaves more space for each individual track."
For the URL and additional information on this patent, see: Butler, Joseph; Moore, David; Draper, Paul Richard; Gilmore, Stephen Francis; Morris, Anthony Paul. Drug Delivery Device. U.S. Patent Number 9586009, filed July 12, 2012, and published online on March 7, 2017. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=9586009.PN.&OS=PN/9586009RS=PN/9586009
Keywords for this news article include: Pharmaceutical Companies, Proinsulin, Peptide Hormones, Peptide Proteins, Drugs and Therapies, Drug Delivery Systems, Sanofi-Aventis Deutschland GmbH.
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