Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
  • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M2005/14204—Pressure infusion, e.g. using pumps with gas-producing electrochemical cell
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
  • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
  • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
  • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
  • A61M2005/14506—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons mechanically driven, e.g. spring or clockwork
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
  • A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
  • A61M5/1483—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags using flexible bags externally pressurised by fluid pressure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
  • A61M5/16877—Adjusting flow; Devices for setting a flow rate

Definitions

• the present invention relates to a delivery device suitable for treatment of diseases or conditions in which a drug has to be applied through the skin of a patient.
• the invention is concerned with a delivery device and a method for the treatment of type 2 diabetes patients.
• Diabetes mellitus is the common name for at least 2 different diseases, one characterised by immune system mediated specific pancreatic beta cell destruction (insulin dependent diabetes mellitus (IDDM) or type 1 diabetes), and another characterised by decreased insulin sen- sitivity (insulin resistance) and a functional defect in beta cell function (non-insulin dependent diabetes mellitus (NIDD ) or type 2 diabetes).
• IDDM insulin dependent diabetes mellitus
• NIDD non-insulin dependent diabetes mellitus
• NIDD non-insulin dependent diabetes mellitus
• UPDS UK Prospective Diabetes Study
• the reason(s) for this remains not clear, but a stress situation of the beta cells may be involved. This deterioration can be detected as an overall increase in blood glucose levels, where the rise in night time blood glucose levels results in increased fasting blood glucose levels having an impact on the overall glycaemic control.
• type 1 diabetes The principal treatment of type 1 diabetes is straight forward substitution of the missing insu- lin secretion, whereas treatment of type 2 is more complicated.
• drugs which increase insulin sensitivity e.g. drugs which increase insulin sensitivity
• decrease hepatic glucose output e.g. metformin
• reduce glucose uptake from the gut alfa glucosi- dase inhibitors
• drugs which stimulate beta cell activity e.g. sulfony- lurea/meglitinides.
• All these drugs are used regularly, and very often in combination with each other.
• beta cell stimulators will eventually fail to stimulate the cell, and the patient has to be treated with insulin, either as mono therapy, or in combination with oral medication in order to improve glu- cose control.
• Patients with type 2 diabetes also often have problems with dyslipidemia, hy- pertension, and obesity, all of which are independent risk factors for developing macro- vascular diseases. This means that patients with type 2 diabetes often receive a plethora of drugs.
• Insulin treatment represents several problems for the patient as well as for the therapist: (i) Presently, insulin has to be injected in order to maintain its full biological potential. The insulin doses needed to control blood glucose excursions will depend on a number of factors, which will vary from day to day, e.g. size, type, and timing of food intake, stomach and gut function as well as exercise level, (ii) The blood glucose levels are also determined by several counter regulatory hormones, the most prominent being glucagon, cortisone, and epinephrine.
• protracted insulins are administered once or twice daily
• short acting insulin is administered in connection with meals as a bolus injection.
• a major shortcoming of this treatment is the relative unreliability of the longer acting insulin preparation.
• the most commonly used insulin is the NPH which is characterized by a relatively rapid and pronounced start of action, and the plasma curve is clearly bell shaped meaning that the patients most of the time either get to much insulin or to little insulin.
• Newer insulin formulations, (insulin glargine, insulin detemir) are addressing this issue.
• a much more stable basal plasma insulin level is obtained by a relatively continuous subcutaneous insulin infusion us- ing a pump.
• the pump can also be used for administering bolus infusions through the same catheter.
• the effect on overall metabolic control, determined from HbA 1c levels, is promising, and pump treatment in this group is able to produce glucose levels within the normal range. The outcome seems slightly better than data obtained with the multiple injec- tion therapy, but both are capable of maintaining patients with good glycaemic control as indicated by HbA c value in the normal range.
• a potential benefit when using a pump is the possibility of increasing the basal rate in the early morning hours, where the patient will need a little more insulin due to peaks of counter regulatory hormones. It will represent, however, a practical challenge, as the effect of the counter regulation is not constant and there will there- fore be a risk of overdosing. On the other hand, it may turn out to be very useful in certain patients even if the insulin increase is not 100% optimal.
• NPH insulin NPH insulin
• combination therapy the oral medication during the day
• the patient does not have to take insulin injections during the day, do not have to balance food in- take (e.g. size and time) with prandial insulin doses, and gain less weight as compared to full insulin treatment, see Yki-Jarvinen H. et al. Comparison of insulin regimens in patients with non-insulin-dependent diabetes mellitus. N. Eng J. Med 1992; 327: 1426-1433, Puhakainen I, Taskinen M-J, Yki-Jarvinen H. Comparison of acute daytime and nocturnal insulinization on diurnal glucose homeostasis in NIDDM.
• insulin injections could be used as an early supplement to oral drugs in the treatment of type 2 diabetes.
• experience has shown that this very often does not happen, the reasons being many and diverse and based upon concerns originating from both the medical practitioner, typically the patients general practitioner, and the patient.
• injections are very cumbersome as the patient has to provide and store insulin in a proper way, to carefully remember to take the injections (one cannot count the remaining number of tablets as it is possible with oral treatment), and ultimately the patient has to inject insulin into the body using a needle.
• the latter action is perhaps the major patient related obstacle to the early introduction of insulin therapy as many people are afraid of needles, find the action both painful and unpleasant and, last but not least, they feel that needle treatment can only be associated with being “seriously ill", an association which is much weaker when taking oral drugs in the form of tablets which is just a "normal” occur- rence like taking a tablet against headache or taking vitamins.
• patient compliance is a major issue as the "relative" need for insulin (i.e. the patient is not in urgent need for treatment with insulin) has to be held up against the risks associated with home treatment using insulin. More specifically, the medical practitioner will be concerned with the risk of overdosing (e.g. the patient taking too large doses and/or taking too many injections) and thereby the risk for hypoglyce- mic incidences. As many patients are middle-aged or elderly they are not used to, and perhaps do not understand, the kind of accuracy needed in insulin treatment, this in contrast to most diabetes type 1 patients which have started insulin treatment relatively early in life.
• the insulin profiles achieved with a bedtime injection are not ideal, either resulting in a bell-shaped curve from NPH insulin, or a very flat curve from newly developed protracted in- sulin types such as insulin glargine or insulin detemir, where a therapeutic level is build up slowly and where overdosing is a real issue, due to the very long acting profile.
• the present invention is based on the realization that a device and method should be provided which is easy to use, which to a high degree minimizes the risks of overdosing, and which may help to break the patients' "emotional" barriers against insulin injections.
• the present invention is based on the concept of drug treatment performed substantially only during the approximately 8 hours during which a patient is at sleep (i.e. typically the night but could, indeed, be any 8 hours during a 24 hour day).
• a delivery device comprising a reservoir for insulin as well as means for allowing the contained insulin to be transferred to the body of the patient (user) during approximately 7-9 hours (e.g. 8 hours) or less in a controlled manner where after expelling is stopped, either due to the expelling means being stopped or due to the reservoir being empty.
• controlled manner indicates that the insulin is delivered substantially in accordance with a predefined rate or profile.
• the transfer rate may be substantially constant, increasing or decreasing during the infusion period, or having any other desired profile just as the profile may be settable or programmable by the user or the attendant medical person.
• controlled refers to a normal situation of use under normal circumstances, e.g. if the outlet from the reservoir is blocked for some reason, delivery of the preset amount of insulin may not take place or only in part.
• the insulin is preferably infused subcutaneously through a small needle in fluid communica- tion with a reservoir outlet means.
• the outlet means will normally be closed until connected to a needle or corresponding device.
• the needle may be attached directly to the outlet opening or via a flexible catheter tubing.
• a very fine needle can be used in contrast to the larger needle needed when the same amount of insulin has to be injected using a conventional syringe over a very short period, e.g. 10 seconds.
• the term infusion is normally associated with delivery through a needle, however, when in the following the term infusion is used instead of the term delivery this is not intended to restrict the disclosure to any specific means for the delivery of a drug to the body of a patient.
• the infusion device is in the form of a "patch" comprising a lower surface provided with adhesive means and adapted to be arranged against and attached to a skin surface of the user, an infusion needle being arranged corresponding to the lower surface.
• the needle is introduced subcutaneously as the infusion device is placed on the skin.
• the needle is "hidden” on the lower surface of the device, the patient can mount the device without having to look as the needle, just as the very fine needle assures that insertion is practically painless.
• the infusion device is provided with the needle in a retracted, preferably hidden, position, such that the needle can be advanced after the device has been mounted on the skin.
• the needle insertion means are combined with actuation means adapted to initiate infusion of the contained insulin.
• This arrangement allows the skin-contacting surface to be placed on the skin (this surface being suitably provided with an adhesive coating or the device being provided with some other means of retaining the skin-contacting surface on the skin), and then a relative move- ment between the base member and the cartridge causes the penetration of the skin (and optionally, the actuation of the expelling means).
• the reservoir contains only a small amount of insulin corresponding to what is needed during the 8 hours the infusion device is adapted to be used, i.e. corresponding to the amount which may otherwise be injected at bedtime as a single injection.
• the basal infusion level for a type 2 patient on early combination therapy is determined based on bodyweight and will be in the range of 5 to 50 units (IU), normally 10-40 IU, per 8 hours, depending on insulin sensitivity. As most of the patients are relatively resistant to insu- lin, it is not imperative to titrate the dose meticulously as the patients still have a certain capability to counter regulate, and the doctor can have 3-5 night pumps at his disposal, either with the same infusion rate (ml/hour) and different insulin concentrations, or with the same insulin concentration but with different infusion rates.
• an infusion device comprising a reservoir with insulin as well as means for allowing the contained insulin to be transferred to the body of the patient in a controlled manner, wherein the reservoir contains an amount of insulin in the range from 5 to 50 IU, preferably from 10 to 40 IU, and the infusion device is adapted to transfer the insulin during a period of up to approximately 8 hours.
• the insulin may be fast acting for which a relatively constant infusion rate over approximately 8 hours may be used, or the insulin may be a slower acting type in which the insulin may be infused over a shorter period of time, just as slower acting insulin to a certain degree will "compensate" for any inaccuracies in the infusion rate provided by the infusion device.
• a mixture of faster and slower acting insulins may be used.
• Rapid-acting insulin e.g. insulin Aspart
• peak time e.g. 1 minute
• duration e.g. 1 hour
• Rapid-acting insulin e.g. insulin Aspart
• Short-acting (regular) insulin usually reaches the blood within 30 minutes after injection. It peaks 2 to 4 hours later and stays in the blood for about 4 to 8 hours.
• Intermediate-acting (NPH and lente) insulins reach the blood 2 to 6 hours after injection.
• a system comprising at least two infusion devices each comprising a prefilled reservoir with insulin as well as means for allowing the contained insulin to be transferred to the body of the patient in a controlled manner, the reservoir containing from 5 to 50 IU, preferably from 10 to 40 IU, of insulin and the infusion devices being adapted for transferring the contained insulin during a period of up to approximately 8 hours, wherein each reservoir contains a different amount of insulin, thereby allowing a patient to be provided with the most suitable infusion device among the at least two infusion devices.
• 4 different devices containing respectively 10, 20, 30 and 40 IU may be provided, however, a different number of devices containing different amounts of insulin may be provided.
• the infusion device comprises means for allowing the contained insulin to be transferred to the body of the patient.
• These means may take any desirable form providing the desired function, but presently pump arrangements comprising a conveying ar- rangement connected to the reservoir (i.e. an outlet to be associated with needle infusion means) and including a pressure generating device for feeding the liquid contained in the reservoir by pressure or suction application from the reservoir to the body are preferred for transferring the insulin contained in the reservoir to the patient.
• a number of different pump principles may be utilized, e.g.
• osmotic pumps as known from for example US patents 4,340,048 and 4,552,561, piston pumps as known from for example US patent 5,858,001, membrane pumps as known from for example US patent 6,280,148, flow restric- tor pumps (also known as bleeding hole pumps) as known from for example US patents 2,605,765 and 5,957,895, and gas generating pumps as known from for example US patent 5,527,288, which all in the last decades have been proposed for use in durable (refillable) and/or disposable (prefilled) drug infusion systems, however, until now only insulin infusion systems adapted to be used for considerably longer time than 8 hours have been proposed, thereby failing to provide a solution to the above-identified problems associated with the early treatment of diabetes type 2.
• the infusion device may be provided as a prefilled, entirely disposable device or as a disposable, prefilled portion comprising the reservoir, in combination with a durable control portion adapted to control the pump means which may be entirely or partly incorporated in the disposable portion. In the latter case the patient simply attaches a new disposable pump portion each evening.
• the control portion may be programmable, which option may or may not be accessible to the patient.
• the present invention may also be implemented in the form of a multi-use pump unit which may be either prefilled or refillable, and which is specifically adapted to deliver a given profile of a drug during the specified period of approximately 8 hours after which the pump will automatically stop until it is restarted for a new infusion cycle.
• the delivery profile will basically be volume based whereas for a prefilled device the delivery profile may be based on activity (e.g. IU of insulin). Indeed, for a given drug having a given activity per unit of volume, a delivery profile based on activity can be calculated.
• activity e.g. IU of insulin
• the term prefilled is used to characterize a device which is supplied to the end-user in a prefilled condition.
• the drug reservoir of the device is adapted for not being refillable, e.g. the reservoir does not contain any user- accessible valves or self-sealing filling arrangements allowing for easy refilling.
• the term refillable covers both the situation in which a reusable reservoir is refilled and the situation in which a prefilled reservoir (e.g. a cartridge) is inserted into a given delivery device.
• the infusion device may be of a relatively simple type dispensing with such features as an alarm and additional safety features, this in contrast to (more sophisticated) pumps comprising a larger amount of insulin.
• an infusion device comprising a durable control portion is preferred, many such advanced features may be readily incorporated, e.g. flow sensors, alarms, a display etc.
• an infusion device which in a preferred embodiment appears like a simple patch with a hardly recognizable needle having almost no resemblance to traditional insulin injection devices such as syringes and pens, which is easy to use by simply attaching it to a skin surface before going to bed and removing it in the morning.
• a method for the treatment of a patient suffering from diabetes type 2 comprising the steps of: providing an infusion device adapted to infuse an amount of insulin to a patient, establishing at bedtime a fluid communication between the infusion device and the body of the patient, infusing an amount of maximum 50 IU, preferably 10-40 IU, of insulin during a sleep period of approximately 8 hours, and removing the infusion device from the patient after approximately 8 hours.
• a first object of the present invention has been to provide an improved treatment for patients suffering from diabetes type 2
• the principles of the present invention may be used also in the treatment of other deceases in which a given drug necessarily or advantageously is infused over a prolonged period of time, e.g. several hours.
• a device for delivering a liquid drug into the body of a patient comprising: a reservoir comprising, in a situation of use, an outlet, an amount of a drug contained in the reservoir, expelling means for expelling the drug out of the reservoir through the outlet, and actuating means for actuating the expelling means, wherein the expelling means upon actuation is adapted for expelling a pre-determined amount of the drug contained in the reservoir during a period of approximately 7-9 hours in a controlled manner, after which period expelling is stopped, either due to the expelling means being stopped or due to the reservoir being empty.
• the term “during” is indicated that the period of time between start of infusion and end of infusion corresponds to the specified timer interval, however, it does not imply that the infusion is constant or that the infusion rate may not be zero for one or more intervals of time during that period of time, e.g. when using a pulsatile infusion pattern.
• growth hormone e.g. human or non-human, analogs, biologically active fragments and derivatives thereof, collec- tively called GH
• infusion during a period of approximately 8 hours in many cases would be more effective than one or more single injections during a period of 24 hours.
• GH secretion occurs in a pulsatile fashion and it is thought that changes in GH pulse amplitude are of great importance for longitudinal growth.
• the pulses are distributed over the 24 hours of the day, the largest pulses are found during the period of sleep (i.e. typically during the night) just as relative more pulses are found during this period.
• a delivery device comprises expelling means providing a pulsatile delivery rate.
• a method for the treatment of a patient suffering from a decease comprising the steps of: providing an delivery device adapted to infuse to a patient an amount of a drug beneficial for the treatment of the de- cease, establishing at bedtime a fluid communication between the delivery device and the body of the patient, delivering a therapeutic amount of the drug during a period of approximately 7-9 hours, and disconnecting the fluid communication between the delivery device and the body of the patient after approximately 7-9 hours.
• the period of sleep is used.
• the infusion device may also be in the form of a traditional programmable infusion pump as used for example in pump treatment of type 1 diabetes patients (this may be suitable in certain circumstances such as a trial phase or during hospitalization), however, to fully benefit from the concept of the present invention the infusion device is advantageously of the above-described type, i.e. a prefilled, disposable infusion device specifically adapted to infuse a contained amount of insulin during a maximum of approximately 8 hours.
• expelling means is used as a general term covering situations in which drug is either forced from the reservoir by applying an external force or drawn or sucked from the reservoir using means arranged distally to the reservoir.
• drug is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension.
• Representative drugs include pharmaceuticals such as peptides, proteins, and hormones, biologically derived or ac- tive agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
• the term “subcutaneous” infusion is meant to encompass any method of transcutaneous delivery to a subject.
• needle defines a piercing member adapted to penetrate the skin of a subject.
• fig. 1 shows a perspective view of an infusion device in an initial state
• fig. 2 shows a perspective view of the infusion device of fig. 1 in an actuated state
• fig. 3 shows a "horizontal" cross-sectional view of the infusion device of fig. 2
• fig. 4 shows a first "vertical" cross-sectional view of the infusion device of fig. 2,
• fig. 5 shows a second "vertical" cross-sectional view of the infusion device of fig. 2,
• fig. 6A shows in detail a flow rest ctor
• fig. 6B shows in detail an infusion needle
• figs. 7A-7E shows different expelling means suitable for use with the invention.
• fig. 8A and 8B show embodiments of multi-use infusion pumps.
• FIG. 1 shows a schematic representation of an embodiment of the invention.
• the configuration of the different structures as well as there relative dimensions are intended to serve illustrative purposes only.
• the terms “upper”, “lower”, “right” and “left” or similar relative expressions are used, these only refer to the appended figures and not to an actual situation of use.
• the terms “horizontal” and “vertical” refer to planes parallel with respectively perpendicular to a lower surface of the device to be described.
• fig. 1 shows an infusion device 1 comprising a housing 10 and there from protruding actuation button 20.
• the housing comprises an upper surface 2 and a lower surface 3 (not to be seen) adapted to be arranged against a skin surface of a user.
• the upper surface is provided with a transparent window 4 allowing the user to view a drug reservoir arranged within the housing.
• the infusion device has been arranged against the skin of a user and the actuation button has pressed into the housing by the user thereby actuating the infusion device as will be explained in detail below.
• the housing comprises an upper wall 11 , a lower planar base plate 12, side wall portions, an end wall 13 with an outer planar surface, and relative to the latter an opposed open end.
• the housing comprises a first central wall 14 and a second oblique wall 15 in combination defining three compartments, a drive compartment 16, a reservoir compartment 17 and a needle compartment 18.
• the drive compartment forms a flat cylinder with an open proximal end and a substantially closed distal end.
• a piston 30 is siidingly arranged in the cylinder di- viding the drive compartment in a distal fluid compartment 31 filled with a viscous drive fluid (e.g. silicon oil), and a proximal spring compartment 32.
• a viscous drive fluid e.g. silicon oil
• the actuation button 20 comprises a skirt portion 21 siidingly received in the cylinder thereby closing the spring compartment.
• the spring compartment are arranged two helical compression springs 33 acting on the piston, however, any compressible material or member providing a spring action or any other means providing or generating a force (e.g. gas generating means or a liquid/gas mixture) acting on the piston may be utilized.
• the actuation button further comprises a wedge portion 22 to be received in the needle compartment.
• the reservoir compartment comprises a flexible drug reservoir 40 with an insulin-containing drug formulation.
• the reservoir is preferably manufactured from a transparent material allowing the user to view and control the drug through the window 4.
• the reservoir In the initial state, i.e. before any drug has been expelled from the infusion device, the reservoir has a configuration substantially corresponding to the configuration of the reservoir compartment, thereby forming a neglectable cavity 19 (or dead-space) between the two compo- nents.
• the space may be filled with a fluid (for illustrative purposes the gap between the reservoir and the reservoir compartment is relatively large).
• the dead-space represents a cavity in a substantially fully collapsed state.
• a U-formed membrane element 41 formed from a self-sealing material and comprising upper and lower membrane portions 42, 43.
• an outlet opening 34 from the fluid compartment and an inlet opening 44 to the reservoir compartment is formed.
• the infusion device further comprises a flow restrictor member 50 (see fig. 6) comprising a planer surface 51 in which a tortuous path 52 is formed between proximal and distal end por- tions 53, 54.
• the flow restrictor member 50 is bonded to the outer planar surface of the housing end portion with the proximal and distal end portions in register with the outlet 34 respectively the inlet openings 44. In this way a flow register is formed between the two openings.
• the resistance of the flow restrictor, the viscosity of the drive fluid and the force provided by the compressed springs will determine the rate at which the drive fluid will be forced through the flow restrictor to the drug compartment.
• the infusion device further comprises a hollow infusion needle 60 as shown in fig. 7, comprising a distal pointed end 61 adapted to be introduced through a skin surface, a closed proximal end at which a needle wedge 62 is formed.
• a needle wedge 62 is formed in the body of the needle.
• an opening 63 is formed in flow communication with interior of the needle.
• the proximal end of the needle is arranged in the needle compartment and with the needle body protruding through an opening 64 formed in the first wall 15 into the drug compartment and further into the reservoir.
• the needle In the initial state (as supplied to the user and not shown in fig. 5) the needle penetrates the upper membrane portion 42 with the distal end 61 arranged between the upper and lower mem- brane portions 42, 43 inside the reservoir.
• the user actuates the device by fully depressing the actuation button 20 until it locks in place in a recessed position (locking means arranged between the button and the housing is not shown in the figs.) whereby simultaneously the springs 33 are compressed and the wedge portion 22 is moved into the needle compartment.
• the wedge portion comprises a lower oblique surface 23 in sliding contact with the needle wedge 62 whereby the wedge portion forces the needle downwardly as it is pressed into housing.
• the pointed distal needle end 61 penetrates the lower membrane portion 43 and is forced out through an opening 65 formed in the base portion.
• the infusion needle As the infusion device is attached to the skin surface of the user, the infusion needle is hereby introduced through the skin.
• the needle opening 63 When the needle is in its fully extended position, the needle opening 63 is positioned between the two membrane portions whereby a fluid communication is established from the drug reservoir to the user.
• the drive fluid starts to be expelled from the fluid compartment 31 and through the flow restrictor to the cavity portion 19 where it gradually will compress the flexible reservoir and thereby force out the therein contained insulin-containing drug through the needle and into the user.
• a traditional infusion set is used, however, in an alternative configuration (see fig. 8B) the same type of pump may be used in combination with a needle which is connected directly to the pump, the combination providing a unitary device.
• the term "unitary" is used to define a device which can be handled and operated by the user as a single device, this in contrast to the above-described embodiment in which the pump 100 and the infusion set 150 is interconnected by a relatively long and flexible tube.
• the needle unit comprises a lower surface, the pointed needle end being moveable between an initial position in which the first needle portion is retracted relative to the lower surface, and a second position in which the pointed end of the first needle portion projects relative to the lover surface.
• the lower surface is in the form of a mounting surface adapted for application against the skin of the subject.
• the needle can be inserted after the pump unit with the attached needle unit has been mounted on the patient, e.g. by adhesive means or by any other suitable means securing that the needle unit is firmly held in place.
• the connection between the reservoir and the distal needle end is short and narrow such that the venting procedure may be dispensed with due to the small amount of entrapped air.
• an object of the present invention is to provide a delivery device and a method which are safe and simple is use yet provide an effective medical treatment.
• an electronically controlled pump as disclosed in fig. 8 may be programmable to provide a wide varity of infusion profiles suitable for a varity of patients, the programming means should not be accessible by the patient but only by e.g. the attending doctor.
• the programming may take place during manufacture only, whereby a number of different devices is supplied to the market, e.g. 4 different pumps supplying 10, 15, 20 or 25 units of insulin during an 8 hour pump cycle.

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• Health & Medical Sciences (AREA)
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• Heart & Thoracic Surgery (AREA)
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• General Health & Medical Sciences (AREA)
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• Infusion, Injection, And Reservoir Apparatuses (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

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• 2002
  • 2002-07-31 EP EP02388048A patent/EP1386626A1/de not_active Withdrawn
• 2003
  • 2003-07-12 WO PCT/EP2003/007560 patent/WO2004012796A1/en not_active Application Discontinuation
  • 2003-07-12 AU AU2003281810A patent/AU2003281810A1/en not_active Abandoned
  • 2003-07-12 EP EP03740459A patent/EP1526883A1/de not_active Withdrawn

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