Source: https://patents.com/us-10272199.html
Timestamp: 2019-11-13 22:59:36
Document Index: 360701058

Matched Legal Cases: ['Application No. 60', 'art 450', 'art 1', 'art 2', 'art 2', 'art 1', 'art 2', 'art 1']

US Patent # 1,027,2199. Device for drug delivery - Patents.com
United States Patent 10,272,199
Yodfat , et al. April 30, 2019
Delivery of more than one therapeutic fluid as a means to control symptoms of a health conditions is disclosed. More than one therapeutic fluid may be dispensed from more than one reservoir and delivered to a user's body via one or more cannula that penetrate the skin. The therapeutic fluids may be delivered by action of one or more pumping mechanisms that may be controlled by a processor in a portable, ambulatory device. The therapeutic fluids may optionally be insulin and one or more of an amylin analog, pramlintide acetate and an exenatide, and the health condition may optionally be diabetes. This device can be used in combination with a glucometer.
Yodfat; Ofer (Maccabim-Reut, IL), Shapira; Gali (Haifa, IL)
Family ID: 1000003978218
14/857,991
US 20160001002 A1 Jan 7, 2016
12452484 9173991
PCT/IL2008/000915 Jul 2, 2008
60958220 Jul 2, 2007
Current CPC Class: A61M 5/1723 (20130101); A61M 5/1408 (20130101); A61M 5/14244 (20130101); A61M 5/14228 (20130101); A61M 2005/1726 (20130101); A61M 2005/14208 (20130101)
Current International Class: A61M 5/142 (20060101); A61M 5/172 (20060101); A61M 5/14 (20060101)
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Ceriello, Postprandial Hyperglycemia and Diabetes Complications: Is It Time to Treat?, Diabetes, 54:1-7 (2005). cited by applicant .
DCCT Trial Research Group, The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus, N.E. J. Med, 329:977-986 (1993). cited by applicant .
El-Khatib et al., Pharmacodynamics and Stability of Subcutaneously Infused Glucagon in a Type 1 Diabetic Swine Model in Vivo, Diabetes Tech. Therapeutics, 9(2):135-144 (2007). cited by applicant .
International Search Report pertaining to PCT/IL2008/000915, dated Feb. 12, 2009. cited by applicant .
Karl et al., Pramlintide as an Adjunct to Insulin in Patients with Type 2 Diabetes in a Clinical Practice Setting Reduced A1C, Postprandial Glucose Excursions, and Weight, Diabetes Tech. Therapeutics, 9(2):191-199 (2007). cited by applicant .
Nathan et al., Intensive Diabetes Treatment and Cardiovascular Disease in Patients With Type 1 Diabetes, N.E. J. Med., 353(25):2643-2653 (2005). cited by applicant .
Ratner, et al., Adjunctive Therapy with the Amylin Analogue Pramlintide Leads to a Combined Improvement in Gylcemic and Weight Control in Insulin-Treated Subjects with Type 2 Diabetes, Diabetes Tech. Therapy, 4(1):51-61 (2002). cited by applicant .
UKPDS Group Trial, Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 28, BMJ, 317:703-713 (1998). cited by applicant .
UKPDS Trial, Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33), Lancet, 352:837-853 (1998). cited by applicant .
Written Opinion pertaining to PCT/IL2008/000915, dated Feb. 12, 2009. cited by applicant.
Primary Examiner: Gilbert; Andrew M
This application is a continuation of U.S. application Ser. No. 12/452,484, filed Jan. 4, 2010, now U.S. Pat. No. 9,173,991, which is a 35 U.S.C. .sctn. 371 national stage entry of PCT/IL2008/000915, which has an international filing date of 2 Jul. 2008 and claims priority to U.S. Provisional Patent Application No. 60/958,220, filed on 2 Jul. 2007. The present application incorporates herein by reference the disclosure of each of the above-referenced applications in its entirety.
1. A portable therapeutic fluid delivery device having a form factor that permits ambulatory use by a user, the device comprising: a first reservoir for containing a first therapeutic fluid; a second reservoir for containing a second therapeutic fluid; at least one cannula in fluid communication with the first and/or second reservoir, the at least one cannula being disposed to penetrate the user's skin to deliver the first and/or the second therapeutic fluid subcutaneously at a dosing rate; at least one pumping mechanism that delivers the first therapeutic fluid from the first reservoir at a first dosing rate and delivers the second therapeutic fluid from the second reservoir at a second dosing rate to the at least one cannula and into the user; a processor that controls the at least one pumping mechanism; a disposable part; and a reusable part configured to mate with the disposable part to form a dispensing patch unit, wherein the disposable part comprises a housing that contains the at least one cannula, the first reservoir, the second reservoir and a fluid delivery path between the cannula and at least one of the first and second reservoirs, wherein the cannula extends directly from the housing, and the reusable part comprises the processor and the at least one pumping mechanism.
2. The portable therapeutic fluid delivery device as in claim 1, wherein the at least one cannula comprises a first cannula in fluid communication with the first reservoir and a second cannula in fluid communication with the second reservoir.
3. The portable therapeutic fluid delivery device as in claim 1, wherein the first dosing rate is different from the second dosing rate.
4. The portable therapeutic fluid delivery device as in claim 1, wherein the at least one pumping mechanism comprises a first pumping mechanism and a second pumping mechanism, the first pumping mechanism delivering the first fluid from the first reservoir and the second pumping mechanism delivering the second fluid from the second reservoir.
5. The portable therapeutic fluid delivery device as in claim 1, wherein the first therapeutic fluid is insulin, and the first dosing rate comprises a basal dosing component and/or a bolus component.
6. The portable therapeutic fluid delivery device as in claim 1, wherein the second therapeutic fluid is an amylin analog.
7. The portable therapeutic fluid delivery device as in claim 6, wherein the amylin analog comprises pramlintide acetate.
8. The portable therapeutic fluid delivery device as in claim 1, wherein the second therapeutic fluid is a glucagon.
9. The portable therapeutic fluid delivery device as in claim 1, wherein the second therapeutic fluid is an exenatide.
10. The portable therapeutic fluid delivery device as in claim 6, wherein the first and/or second dosing rate is based on expected calorie and/or carbohydrate intake by the user.
11. The portable therapeutic fluid delivery device as in claim 1, wherein the at least one pumping mechanism comprises a peristaltic pumping mechanism.
12. The portable therapeutic fluid delivery device as in claim 1, wherein the first reservoir and the second reservoir are coupled to a single housing.
13. The portable therapeutic fluid delivery device as in claim 1, further comprising one or more buttons via which the user can adjust the first and/or the second dosing rate.
Much of the burden of the disease to the user and to health care resources can occur due to long-term tissue complications that affect both the small blood vessels (microangiopathy, causing eye, kidney and nerve damage) and the large blood vessels (causing accelerated atherosclerosis, with increased rates of coronary heart disease, peripheral vascular disease and stroke). The Diabetes Control and Complications Trial (DCCT) has demonstrated that development and progression of the chronic complications of diabetes are greatly related to the degree of altered glycemia as quantified by determinations of glycohemoglobin (HbAlc). (DCCT Trial, N. Engl. J. Med 1993; 329: 977-986, UKPDS Trial, Lancet 1998; 352: 837-853. BMJ 1998; 317, (7160): 703-13 and the EDIC Trial, N. Engl. J. Med. 2005; 353, (25): 2643-53). Thus, maintaining normolycemia by frequent glucose measurements and adjustment of insulin delivery accordingly can be quite important.
TABLE-US-00001 TABLE 1 Glycemic index ranges and classifications for selected foods. Classification GI Range Examples Low GI 55 or less Most fruit and vegetables (but not potato), oats, buckwheat, whole barley, All-bran Medium GI 56-69 Sucrose, basmati rice High GI 70 or more Corn flakes, baked potato, jasmine rice, white bread, white rice, Mars bar
An after-meal or post-prandial glycemic peak (hyperglycemia) is defined as the net rise in a patient's blood glucose concentration that occurs from before eating to the highest point after eating. The ADA goal for diabetic treatment is a glucose concentration level that is less than 180 mg dl''1 at approximately 1-2 hrs after the start of meal. Increasing evidence suggests that postprandial hyperglycemia is a contributing factor to the development of atherosclerosis. The postprandial phase can be characterized by a rapid and large increase in blood glucose levels. The association of postprandial "hyperglycemic spikes" with the onset of cardiovascular complications has recently received much attention. Postprandial hyperglycemia can be a direct and independent risk factor for cardiovascular disease (CVD). The mechanisms through which acute hyperglycemia exerts its effects may be identified in the production of free radicals. Correcting the postprandial hyperglycemia may form part of the strategy for the prevention and management of CVDs in diabetes {Diabetes 2005; 54:1-7). Other, short term problems, such as for example tiredness, concentration difficulties, decreased desire to move, mood shifts, and enhanced hunger, can also be attributed to postprandial hyperglycemia. As such, prevention of post-prandial hyperglycemia can be quite important.
Amylin is a second .beta.-cell hormone that is co-localized and co-secreted with insulin in response to meals. Consequently, .beta.-cell dysfunction in insulin-requiring subjects with type 1 or type 2 diabetes is characterized by a markedly impaired postprandial secretory response of both insulin and amylin. Amylin acts as a neuroendocrine hormone that complements the effects of insulin in postprandial glucose regulation through several centrally mediated effects that can include a suppression of postprandial glucagon secretion and a vagus-mediated regulation of gastric emptying, thereby helping to control the influx of endogenous and exogenous glucose, respectively. Amylin has also been shown to reduce food intake and body weight, consistent with an additional satiety effect. Consistent with these findings, mealtime amylin replacement, as an adjunctive therapy to insulin delivery, can improve metabolic control in diabetic subjects.
FIG. 1 shows the co-secretion of amylin and insulin in response to meals in a healthy subject. Both hormones are co-localized in the .beta.-cells of the pancreas. .beta.-cell dysfunction in insulin-requiring subjects with type 1 or type 2 diabetes is characterized by a markedly impaired postprandial secretory response of both insulin and amylin.
Pramlintide can be injected subcutaneously with a standard insulin syringe, rendering the dosage flexible. For weight loss, maximum doses are administered and for normalizing postprandial glucose levels, lower doses are indicated. The dosing recommended by the manufacturer for normalizing post-prandial glucose levels are the following: starting with 2.5 units and increasing to 5 units, then 7.5 units, and 10 units before each meal if no nausea is encountered for three consecutive days.
FIG. 2 shows mean (.+-.SE) values for seven-point glucose profiles performed before (open circles) and after 6 months (solid circles) of pramlintide therapy in patients with type 2 diabetics on insulin therapy. The blood glucose concentrations were assessed within 0.5 h before and 1.5-2 h after breakfast, lunch, and dinner and at bedtime. It can be seen that both fasting and postprandial glucose concentrations were significantly reduced compared to baseline (P<0.05). (Diabetes Technology & Therapeutics 2007; 9 (2): 191-99.)
Various features of the current subject matter can provide one or more benefits and/or advantages that can include, but are not limited to provision of a device that can dispense insulin and one or more additional injectable anti diabetic drugs (such as for example an amylin analog like pramlintide) to prevent post-prandial hyperglycemia and achieve a better glycemic control for a diabetic patient. The current subject matter can also be used in other applications in which delivery of more than one therapeutic fluid, formulation, or other substance to a patient or subject is desirable. One or more sensing apparati or other sensing data streams can be incorporated with the current subject matter to provide real time or near real time measurement of one or more factors that might impact the desired dose of the one or more therapeutic fluids to be delivered. Automated control, or alternatively automated alerting that user action is required can be provided in response to these measurements to allow prompt dosing of a therapeutic fluid in response to a measured body condition, such as for example an elevated or depressed blood glucose level. A continuous subcutaneous insulin infusion device can be provided that infuses basal insulin dosages and pre-meal bolus insulin dosages. In addition, the infusion device can comprise a pramlintide subcutaneous infusion mechanism that allows the user to administer the amylin analog before a meal and prevent post-prandial hyperglycemia. Devices according to various implementations of the current subject matter can be miniature, discreet, and economical for the user and highly cost effective. Relatively expensive components of such devices can optionally be provided in a reusable part that mates with a disposable part that contains relatively inexpensive components that can be discarded and replaced more frequently.
For the purposes of promoting an understanding of the subject matter described herein, which can include one or more features and variations as described below, references may be made to specific implementations having discrete feature sets. The terminology used herein is for the purpose of describing particular implementations only, and is not intended to limit the scope of either the disclosed subject matter or of the particular inventions that are claimed below. For example, references to the delivery of insulin and/or the treatment of diabetes are intended to serve as illustrative examples of broader inventive concepts. Use of other therapeutic fluids, either in addition to or in place of insulin, as well as materials and apparatuses compatible with the same, are within the contemplated scope of the current subject matter. Additionally, as used throughout this disclosure, the singular articles "a," "an," and "the" are intended to include both singular and plural references unless the context clearly indicates otherwise. Thus, for example, a reference to "a tube" includes a plurality of such tubes, as well as a single tube, and any equivalents thereof.
FIG. 3a is a schematic diagram that shows an infusion device comprising a dispensing unit that can deliver two therapeutic fluids as well as a remote control unit;
FIG. 3b is a table diagram that shows an example of a dosing recommendation of pramlintide when given as an adjunctive therapy to insulin;
FIG. 4a and FIG. 4b are process flow diagrams illustrating methods for delivering therapeutic fluids for patient treatment;
FIG. 6a, FIG. 6b, and FIG. 6c are schematic diagrams that show a patch infusion device including a cradle unit and a dispensing unit;
FIG. 7a, FIG. 7b, FIG. 7c, and FIG. 7d are schematic diagrams that show a cradle unit and dispensing unit of a patch infusion device;
FIG. 9 is a schematic diagram that shows a patch unit in which the driving mechanism of both therapeutic fluids (such as for example insulin and pramlintide) is a piston-type displacement pump;
FIG. 13a and FIG. 13b are schematic diagrams that show insulin and pramlintide infusion devices containing examples of continuous subcutaneous glucose monitors providing blood glucose readings (BG);
FIG. 16a, FIG. 16b, and FIG. 16c is a schematic diagram that shows three different configurations of an infusion device for delivering two therapeutic fluids including a remote control, infusion patch and a blood glucose monitor.
In some implementations, the dispensing device includes a sensor for measuring glucose levels. Such a sensor that can continuously monitor glucose level is provided, for example, in co-pending and co-owned U.S. application Ser. No. 11/989,678, filed 28 Jan. 2008 and entitled "Fluid delivery system with optical sensing of analyte concentration levels," the disclosure of which is hereby incorporated by reference. In some implementations, a dispensing patch unit can subcutaneously dispense glucagon, in addition to other diabetic agents, such as for example insulin. Endogenous glucagon secretion can be somewhat compromised in type 1 diabetes, since the (absent) .beta.-cells are also themselves sensors for BG concentration (Diab. Tech. Therap. 2007; 9(2): 135-144). Glucagon is released whenever the patient is hypoglycemic or when hypoglycemia is impended (rapidly declining blood glucose levels), and acts as a counter-agent to insulin. The glucagon acts rapidly to prevent blood glucose excursions (i.e. deviation from blood glucose target zone) and thereby achieve normoglycemia. The infusion patch unit that can dispense glucagon and insulin can optionally work in a closed loop system.
Various implementations of the currently disclosed subject matter can provide infusion devices that include a miniature skin adherable infusion patch unit (also referred to herein as a "dispensing patch") that can in some examples be remotely controlled by a remote control unit. The dispensing patch can be discreet and free of inconvenient tubing and can dispense one or more therapeutic fluids, such as for example insulin and/or an amylin analog such as pramlintide from one or more reservoirs via one or more delivery tubes. Fluid motion can be urged by one or more pumping mechanisms, including but not limited to peristaltic pumps, piston-type displacement pumps, and the like. The dispensing patch can in some examples include a disposable part and a reusable part. The reusable part can optionally contain relatively expensive components of the dispensing patch (such as for example a peristaltic pump wheel, driving mechanism and electronics) and the disposable part can optionally contain relatively less expensive components (such as for example a delivery tube, reservoir, and the like). In this manner, a device can have relatively low ongoing operating costs for a user while being highly profitable for manufacturers and payers.
Dispensing patch units consistent with various aspects of the current subject matter can in some variations and implementations include one or more peristaltic pumping mechanisms (peristaltic pump). The peristaltic pump can optionally include a rotatable structure such as a wheel that includes one or more rollers, a stator and a delivery tube. The wheel and rollers can in some variations be located within a reusable part of the dispensing patch and a delivery tube and stator can be located within a disposable part. After disposable and reusable parts are properly paired, the wheel can be rotated and the rollers can squeeze the tube against the stator. Fluid delivery can thereby be maintained in the direction of rotation of the wheel. In some variations, a deformable reservoir that collapses and decreases in volume as fluid is withdrawn therefrom can be used in conjunction with a peristaltic pumping mechanism. Other variations and implementations can include a piston-type displacement pumping mechanism that includes a rigid or semi-rigid reservoir body and a plunger mechanism that can be moved to urge fluid out of the reservoir body.
Pramlintide dosages may be delivered using the remote control unit 1008 of the device. According to some implementations, the user may command administration of any dosage by inputting the value into the remote control unit. Alternatively the user may select a number of quanta of pramlintide to be delivered. In various implementations, the user may select the pramlintide dosage in accordance with the glycemic index (GI) and/or the carbohydrate load of the meal. In some implementations the pramlintide dosage may be chosen from within a grid 111. An example of such a grid is shown in FIG. 3b.
FIG. 4a is a process flow diagram showing an example of dosing recommendations for amylin analog (Pramlintide) used as an adjunctive therapy to insulin. Dosing of pramlintide 400 is dependent on intended use. The intended use is determined at 402. For weight loss at 404, maximum doses can be preferred, while lower doses can be preferable when the goal is to normalize post-meal glucose levels at 406.
If pramlintide is determined to be required a determination can be made at 414 whether the user is a first time user. If not, a method of determining an appropriate dose can be chosen at 416. One option, at 420 is an insulin total daily dose (TDD) method in which the device delivers a discrete predetermined dosage of pramlintide at 422, for example in multiples of some base dosage, which is calculated as percentage of TDD. In this example, 10% of the user's insulin TDD can be delivered as a bolus. The bolus can optionally be delivered by pressing the bolus button or buttons on a dispensing patch unit 1010. For example if the TDD is 50 IU of insulin, each button press can deliver 5 units of pramlintide (3 presses=15 units of pramlintide). Bolus deliveries can also and/or alternatively be controlled using a remote control 1008. An alternative method of determining the dose is according to meal glycemic index (GI) and carbohydrate content at 424. A user can deliver the calculated exact amount of pramlintide in accordance with a table 426 such as that shown in FIG. 3b. Delivery of the selected bolus can optionally be commanded by the remote control.
The optimal pramlintide dosages can also be based on postprandial glucose measurements at 430. In one example, the goal can be to keep the blood glucose peak 2 hours after a meal below 180 mg dL.sup.-1. If the goal is reached at 432, it can be determined that the dosage or dosages are adequate for the user. If the goal is not reached at 434, the dosage or dosages can be adjusted before the following meals.
For weight loss at 404, larger amounts of pramlintide may be needed. The TDD can be determined at 436. If TDD is greater than some threshold, for example 30U, at 440, the user can be initiated with 2 units before the two or three largest meals of the day. If TDD is less than the threshold at 442, the user can be initiated with 1 unit per meal. The dosages can then be increased by 1 unit per meal every three days as long as nausea is not present at 444.
FIG. 4b is a process flow chart 450 that shows a method for monitoring and controlling blood glucose levels. At 452, a determination is made of required dosings of a first therapeutic fluid and a second therapeutic fluid for a user. In some implementations, insulin can be the first therapeutic fluid and an amylin analog such as pramlintide can be the second therapeutic fluid. The required dosing can be based on input data that can in some implementations optionally include data from a sensor that monitors one or more body chemistry indicators and/or activity data from a user that are input via a user interface. Such a user interface can include buttons on a delivery device, a remote control device, or the like, possibly (although not limited to) those described herein. At 454, the first therapeutic fluid is delivered from a first reservoir. At 456, the second therapeutic fluid is delivered from a second reservoir. At 460, the efficacy of the dosing of the two therapeutic fluids is determined. In the example where the therapeutic fluids are insulin and pramlintide and continuous, discrete or semi-continuous monitoring of blood glucose is available, the determination of efficacy can include a determination of whether the patient's blood glucose level remained within a target range. Alternatively or in addition, user inputs regarding his/her perceptions or feelings can be used--for example if the user feels nauseous, light headed, or otherwise experiences symptoms of improperly elevated or depressed blood glucose, he/she can indicate this occurrence via a user interface such as buttons and/or a remote control. The required dosing can be adjusted based on the efficacy of the previous dosing. Dosing of the two fluids need not both be continuous. For example, insulin can be delivered at a basal level with occasional boluses while an amylin analog can be delivered as boluses timed to measured and/or anticipated excursions of blood glucose outside of desired ranges.
In some implementations, insulin delivered via a dispensing patch unit 1010 such as those described herein can be rapid acting (such as for example Humalog) and be given as a pre-meal "food bolus". Long acting insulin (such as for example Glargine, Detemire, etc.) can be injected once a day to meet the basal insulin requirements. The long acting insulin can be delivered via the same cannula as the rapid acting insulin, as detailed below in regards to FIG. 7 or separately at a different remote injection site.
FIG. 6a, FIG. 6b, and FIG. 6c show dispensing patch units 1010 that include a cradle 300 unit and a dispensing patch unit. FIG. 6a shows the cradle 300 unit of the dispensing patch unit 1010. The cradle 300 can be a flat sheet with adhesive layer to be facing the skin and carrying a connection device or other connecting means on its upper side that allows connection and disconnection of the dispensing patch unit 1010. Upon insertion of one or more cannula 6 and 66, the cradle 300 remains adhered to the skin. The cradle 300 anchors the cannulae 6 and 66 and allows connection to the dispensing patch unit 1010. The well can be a tubular protrusion emerging upwardly from the cradle to allow alignment with the outlet port of the dispensing unit and appropriate connection between the needle and the dispensing unit as required for proper fluid delivery to the body.
FIG. 6a shows a cradle unit 300 with a cradle base 301, wells 306 and openings 307 that can accept cannulae, and anchoring latches 302 for the connection and disconnection of the dispensing unit. FIG. 6b shows the cradle unit 300 connected to the dispensing unit. The dispensing unit can include two reservoirs 3 and 33 associated with the two cannulae 6 and 66, where each reservoir 3 and 33 contains a different therapeutic fluid. For example, the first reservoir 3 can contain insulin and the second reservoir 33 can contain pramlintide as shown in FIG. 6b.
As noted above, insulin delivered via the patch infusion device can in some implementations be rapid acting insulin (such as for example Humalog) given as a pre-meal "food bolus". Long acting insulin (such as for example Glargine (Lantus), Detemire, etc.) can be injected once a day to meet the basal insulin requirements. In some variations, the long acting insulin injection can be given via a syringe 398 (for example a piston-type displacement pump) via the same cannula 6 used for delivery of the rapid acting insulin, with the dispensing unit is disconnected, as shown in FIG. 6c.
FIG. 7a, FIG. 7b, FIG. 7c, and FIG. 7d show another illustrative implementation of a cradle unit and dispensing patch unit. FIG. 7a shows a reusable part 1 and a disposable part 2 of the dispensing patch unit 1010. A button 10 that includes a pointer 11 is located on the disposable part 2. FIG. 7b shows the button 10 with the pointer 11. In this example, if the user wishes to administer a bolus of insulin alone, he/she can point the pointer 11 to "insulin" and press the button 10. If the user wishes to administer a bolus of pramlintide alone, he/she may point the pointer 11 to "PMN" and press the button 10. If the user wishes to administer simultaneously a bolus of pramlintide and a bolus of insulin, he/she may point the pointer 11 to "both" and press the button 10. FIG. 7c shows a top view of the cradle unit 300 with two openings 307. One opening 307 can be used for insulin infusion and the other opening 307 can be used for pramlintide infusion. FIG. 7d shows the connection of the cradle unit 300 and the dispensing patch unit 1010.
FIG. 9 shows a dispensing patch unit 1010 in which the pumping mechanisms for delivery of both the first and the second therapeutic fluids (for example insulin and an amylin analog such as pramlintide) are both piston-type displacement pumps. Each of the two therapeutic fluids can be infused from a reservoir 3 and 33 that includes a propelling plunger 70 and 70' and spring 71 and 71' via a delivery tube 17 and 177 and cannula 6 and 66 to the subcutaneous layer 5. The pumping mechanisms 901 and 901' of both piston-type displacement pumps can be connected to an electronic components board 800. In some implementations, both piston-type displacement pumps can be manually operated. In other implementations, the first therapeutic piston-type displacement pump can be controlled by a driving mechanism and the piston-type displacement pump of the second therapeutic fluid can be manually operated.
FIG. 13a shows an implementation in which a current blood glucose (BG) value is measured by an independent subcutaneous glucose monitor 1006 that can in some implementations be a continuous or semi-continuous monitor. FIG. 13b shows an implementation in which the subcutaneous glucose sensing (monitoring) apparatus (1006) is integrated within the dispensing patch unit 1010 of the therapeutic fluid delivery device. The therapeutic fluid dispensing apparatus 1005 and glucose sensing apparatus 1006 constitute a single delivery device. Sensing of blood glucose can be carried out via the insulin infusion cannula 6 or the pramlintide infusion cannula 66 if the device is used for diabetes control and treatment. Single cannula for both dispensing and sensing is described in detail in U.S. application Ser. No. 11/706,606 which is incorporated herein by reference in its entirety.
Alternatively, the sensing apparatus and the dispensing apparatus can have separate cannulae that penetrate the skin 5 and reside in the subcutaneous tissue. The delivery device of this implementation can optionally include two parts--a reusable part 1 and a disposable part 2, where each part can have a corresponding housing 1001 and 1002.
FIG. 16a, FIG. 16b, and FIG. 16c show three possible implementations of devices that each contains a glucometer 90 that can provide blood glucose (BG) inputs. FIG. 16a shows a glucometer 90 located in the remote control unit 1008 of the device, which includes an opening 95 for receiving of a test strip 99. The user extracts blood from the body, places a blood drop on the test strip 99 and inserts the strip 99 into the opening 95. The glucose readings are displayed on a screen 80 of the remote control unit 1008.
FIG. 16b shows a glucometer 90 that is located in the reusable part 1 of the dispensing patch unit 1010. Communication 300 between the glucometer 90 residing in the dispensing patch unit 1010 and the remote control unit 1008 can be provided, thereby allowing programming, data handling, and user inputs. FIG. 16c shows an implementation in which glucose readings are 90 received from an independent glucometer. It should readily be recognized that while the implementations shown in FIG. 16a, FIG. 16b, and FIG. 16c are discussed with regards to glucose monitoring for a diabetic patient, other types of sensing monitors can be substituted while remaining within the scope of the currently disclosed subject matter.
The subject matter described herein may be embodied in systems, apparatus, methods, and/or articles depending on the desired configuration. In particular, various features or implementations of the subject matter described herein may be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations thereof. These various implementations may include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device. Such computer programs (also known as programs, software, software applications, applications, components, or code) include machine instructions for a programmable processor, and may be implemented in a high-level procedural and/or object-oriented programming language, and/or in assembly/machine language. As used herein, the term "machine-readable medium" refers to any tangible computer program product, apparatus and/or device (e.g., magnetic discs, optical disks, memory, Programmable Logic Devices (PLDs)) used to provide machine instructions and/or data to a programmable processor, including a machine-readable medium that receives machine instructions as a machine-readable signal. The term "machine-readable signal" refers to any signal used to provide machine instructions and/or data to a programmable processor.
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