Adhesive and peripheral systems and methods for medical devices

• US 20070219597A1
• Filed: 02/09/2007
• Published: 09/20/2007
• Est. Priority Date: 02/09/2006
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Kamen, Dean, Gray, Larry, Beavis, Russell
• Granted Patent: US 8,113,244 B2
• Time in Patent Office: Days
• US Class Current: 607/60
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 5/0024 for multiple sensor units attached to the patient, e.g. using a body or personal area network
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15119 comprising shape memory alloys
• CPC Class Codes: A61B 5/15121 comprising piezos
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15125 comprising a vacuum or compressed fluids
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/6833 Adhesive patches
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 : with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14506 : mechanically driven, e.g. spring or clockwork
• CPC Class Codes: A61M 2005/1581 : Right-angle needle-type devices
• CPC Class Codes: A61M 2005/1583 : Needle extractors
• CPC Class Codes: A61M 2005/1585 : Needle inserters
• CPC Class Codes: A61M 2005/1586 : Holding accessories for holding infusion needles on the body holding devices for catheters A61M25/02
• CPC Class Codes: A61M 2005/16863 : Occlusion detection
• CPC Class Codes: A61M 2005/1726 : the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 2205/0266 : Shape memory materials
• CPC Class Codes: A61M 2205/0294 : Piezoelectric materials
• CPC Class Codes: A61M 2205/04 : implanted
• CPC Class Codes: A61M 2205/16 : with back-up system in case of failure
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3337 : Controlling, regulating pressure or flow by means of a valve by-passing a pump
• CPC Class Codes: A61M 2205/3341 : stabilising pressure or flow to avoid excessive variation
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3389 : Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/3523 : using telemetric means
• CPC Class Codes: A61M 2205/3546 : Range
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 : with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 : by audible feedback
• CPC Class Codes: A61M 2205/582 : by tactile feedback
• CPC Class Codes: A61M 2205/583 : by visual feedback
• CPC Class Codes: A61M 2205/8206 : battery-operated
• CPC Class Codes: A61M 2205/8237 : Charging means
• CPC Class Codes: A61M 2206/22 : eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 2207/00 : Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2209/045 : for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 2230/201 : Glucose concentration
• CPC Class Codes: A61M 5/141 : with capillaries for restricting fluid flow
• CPC Class Codes: A61M 5/1413 : Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14212 : Pumping with an aspiration and an expulsion action
• CPC Class Codes: A61M 5/14216 : Reciprocating piston type
• CPC Class Codes: A61M 5/14224 : Diaphragm type
• CPC Class Codes: A61M 5/14232 : Roller pumps
• CPC Class Codes: A61M 5/14244 : adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 : of the skin patch type
• CPC Class Codes: A61M 5/1452 : pressurised by means of pistons
• CPC Class Codes: A61M 5/14586 : pressurised by means of a flexible diaphragm
• CPC Class Codes: A61M 5/148 : flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/152 : pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061
• CPC Class Codes: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/162 : Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/168 : 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 flow control in general G05D7/00
• CPC Class Codes: A61M 5/16804 : Flow controllers
• CPC Class Codes: A61M 5/16809 : by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: A61M 5/16813 : by controlling the degree of opening of the flow line
• CPC Class Codes: A61M 5/16831 : Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/16886 : for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 : using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/3287 : Accessories for bringing the needle into the body; Automatic needle insertion A61M5/20, A61M5/31525 take precedence
• CPC Class Codes: A61M 5/365 : Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: A61M 5/5086 : for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: B23P 15/00 : Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
• CPC Class Codes: F04B 43/02 : having plate-like flexible members, e.g. diaphragms F04B43/14 takes precedence
• CPC Class Codes: F04B 43/09 : Pumps having electric drive
• CPC Class Codes: F04B 43/1253 : by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
• CPC Class Codes: F04B 7/00 : Piston machines or pumps characterised by having positively-driven valving
• CPC Class Codes: F04C 2230/60 : Assembly methods
• CPC Class Codes: G01F 22/00 : Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for
• CPC Class Codes: G05B 23/02 : Electric testing or monitoring
• CPC Class Codes: G05D 7/0647 : the plurality of throttling means being arranged in series
• CPC Class Codes: G05D 7/0676 : by action on flow sources G05D7/0688, G05D7/0694 take precedence
• CPC Class Codes: G08C 17/02 : using a radio link
• CPC Class Codes: H04B 7/2609 : Arrangements for range control, e.g. by using remote antennas
• CPC Class Codes: Y10T 29/49236 : Fluid pump or compressor making
• CPC Class Codes: Y10T 29/494 : Fluidic or fluid actuated device making
• CPC Class Codes: Y10T 29/49412 : with assembly, disassembly or composite article making
• CPC Class Codes: Y10T 29/49826 : Assembling or joining
• CPC Class Codes: Y10T 29/49828 : Progressively advancing of work assembly station or assembled portion of work

Abstract

A repeater system may control a pump by using a repeater and a user interface. An adhesive patch system may be used for affixing a pump or other object to a human body. Such an adhesive patch system may include two sets of adhesive members, each member including an adhesive material on at least one side so as to attach to the body. The members of the first set are spaced to allow the members of the second set to attach to the body in spaces provided between the members of the first set, and the members of the second set are spaced to allow members of the first set to detach from the body without detaching the members of the second set. Also, fill stations and base stations are provided for personal pump systems.

Claims

1. A repeater system for controlling a medical device, the system comprising:

a repeater having

short-range reception circuitry for, over a given range, receiving signals from at least one wearable medical device,

short-range transmission circuitry for, over the given range, transmitting signals to the wearable medical device,

longer-range transmission circuitry for, over a longer range exceeding the given range, transmitting the received signals to a user interface located remotely from the patient, and

longer-range reception circuitry for, over the longer range, receiving signals from the user interface; and

a user interface having

interface reception circuitry for receiving signals from the repeater, and

interface transmission circuitry for transmitting signals to the repeater.

2. A repeater system in accordance with claim 1, wherein the interface reception circuitry includes circuitry for receiving signals directly from the wearable device, and wherein the interface transmission circuitry includes circuitry for transmitting signals directly to the wearable device.

3. A repeater system in accordance with claim 1, the repeater comprising:

memory for logging received data.

4. A repeater system in accordance with claim 1, the repeater comprising:

a processor for analyzing received data for the presence of a fault condition.

5. A repeater system in accordance with claim 1, the repeater comprising:

an alarm for notifying a user of the presence of a fault condition.

6. A repeater system in accordance with claim 5, wherein the fault condition includes an occurrence of an event wherein the repeater is separated from the wearable medical device by more than the given range.

7. A repeater system according to claim 1, further comprising a circuitry that is both the short-range reception circuitry and the longer-range reception circuitry.

8. A repeater system according to claim 1, wherein the short range circuitry is adapted to receive signals from multiple medical devices.

9. A repeater system according to claim 1, wherein the medical devices are chosen from the group consisting of wearable and implanted devices.

10. A repeater for controlling a patch-sized pump worn on a subject for delivering fluid to the subject, the repeater comprising:

short-range reception circuitry for, over a given range, receiving signals from the pump, the received signals containing data relating to a volume of fluid delivered by the pump and relating to an alarm condition; and

longer-range transmission circuitry for, over a longer range exceeding the given range, transmitting the received signals to an interface for monitoring the volume of fluid delivered and the alarm condition.

11. A repeater according to claim 10, further including:

longer-range reception circuitry for, over the longer range, receiving control signals from the interface, the control signals containing control information for controlling the pump; and

short-range transmission circuitry for, over the given range, transmitting the control signals to the pump.

12. A repeater in accordance with claim 10, wherein the interface reception circuitry includes circuitry for receiving signals directly from the pump, and wherein the interface transmission circuitry includes circuitry for transmitting signals directly to the pump.

13. A repeater in accordance with claim 10, the repeater comprising:

memory for logging received data.

14. A repeater in accordance with claim 10, the repeater comprising:

a processor for analyzing received data for the presence of a fault condition.

15. A repeater in accordance with claim 10, the repeater comprising:

an alarm for notifying a user of the presence of a fault condition.

16. A repeater in accordance with claim 15, wherein the fault condition includes occurrence of an event wherein the repeater is separated from the pump by more than the given range.

17. A repeater in accordance with claim 16, wherein the alarm condition further includes a flow occlusion or an air bubble detected in the pump.

18. A repeater system for controlling a medical devices, the system comprising:

a repeater having means (i) for, over a given range, receiving signals from at least one wearable medical device, (ii) for, over the given range, transmitting signals to the wearable medical device, (iii) for, over a longer range exceeding the given range, transmitting the received signals to a user interface located remotely from the patient, and (iv) for, over the longer range, receiving signals from the user interface; and

a user interface having means (i) for receiving signals from the repeater, and (ii) for transmitting signals to the repeater.

19. An adhesive patch system for affixation of an object to a human body, the system comprising:

a first set of three or more members, each member including an adhesive material on at least one side so as to attach to the body upon application of pressure, the members disposed around a central region; and

a second set of three or more members, each member including an adhesive material on at least one side so as to attach to the body upon application of pressure, the members disposed around the central region,

wherein the members of the first set are spaced to allow the members of the second set to attach to the body in spaces provided between the members of the first set, and wherein the members of the second set are spaced to allow members of the first set to detach from the body without detaching the members of the second set.

20. An adhesive patch system in accordance with claim 19, wherein at least one member is perforated so as to allow facile tearing off of the member.

21. An adhesive patch system in accordance with claim 19, wherein tearing off of the member relieves irritation of the underlying skin.

22. An adhesive patch system in accordance with claim 19, wherein the central region is adapted to secure a wearable medical device.

23. An adhesive patch system in accordance with claim 19, wherein the adhesive patch is semicircular.

24. An adhesive patch system in accordance with claim 19, further including a peelable backing strip.

25. An adhesion patch system in accordance with claim 19, wherein the members are attached by a fiber.

26. An adhesive patch system in accordance with claim 19, wherein the members of the first set are a first color and the members of the second set are a second color different from the first color.

27. A method for attaching an object to a human body, the method comprising:

providing a first set of three or more members, each member including an adhesive material on at least one side so as to attach to the body upon application of pressure, the members disposed around a central region;

attaching the first set of members to the body so that spaces are left between each of the members, so as to hold the object against the body;

providing a second set of three or more members, each member including an adhesive material on at least one side so as to attach to the body upon application of pressure, the members disposed around the central region;

attaching the second set of members to the body in the spaces between the members of the first set, so as to hold the object against the body with the second set of members; and

after attaching the second set of members to the body, removing the first set of members from the body.

28. A method according to claim 27, further including

providing the object with air passages to permit airflow to the body under the object when the object is attached to the body.

29. A method according to claim 27, wherein the object is a pump for therapeutic of fluid to the body through the skin, and further including

passing through the skin a cannula for delivering the fluid from the pump through the skin,

wherein the cannula is not moved and is left passing through the skin while the second set of members is attached to the body and while the first set of members is removed from the body.

30. A method according to claim 27, wherein the object is a probe for measuring a parameter in the body through the skin, and further including

passing the probe through the skin,

wherein the probe is not moved and is left passing through the skin while the second set of members is attached to the body and while the first set of members is removed from the body.

31. An adhesion system for affixation of an object to a human body, the system comprising:

a central member adapted to secure a wearable object and having an adhesive material on at least one side so as to attach to the body upon application of pressure;

a plurality of peripheral members, each member including an adhesive material on at least one side so as to attach to the body upon application of pressure; and

fibrous connectors for connecting each of the peripheral members to the central member.

32. An adhesive system according to claim 31, wherein the fibrous connectors are elastic.

33. A method of filling a reservoir with a liquid therapeutic, the method comprising:

providing a fill station having

a substantially rigid fill-station base for holding the reservoir at a tilt, and

a substantially rigid fill-station cover attached to the fill-station base, the fill-station cover having a filling aperture for receiving fluid from a syringe, the fill-station cover and the fill-station base defining a volume so as to prevent over-filling of the reservoir;

placing a reservoir in the fill station and closing the fill-station cover over the reservoir;

applying a syringe containing the liquid therapeutic to the filling aperture; and

ejecting the liquid therapeutic from the syringe through the filling aperture into the reservoir.

34. A method according to claim 33, further comprising removing any remaining air in the reservoir after injecting a the desired amount of liquid therapeutic into the reservoir.

35. A method according to claim 33, further comprising viewing the amount of liquid in the reservoir through a window in the fill station cover.

36. A method according to claim 35, further comprising estimating the amount of liquid by comparing the liquid level viewed through the window to a fluid-level indicia.

37. A fill station for filling a reservoir with a liquid therapeutic, the device comprising:

means for holding the reservoir at a tilt, and

means for receiving fluid from a syringe,

means to prevent over-filling of the reservoir;

means for estimating the fluid level of the reservoir even while the reservoir is held at a tilt.

38. A base station for a patch-sized infusion device, the infusion device including a disposable portion and a reusable portion, the disposable portion and the reusable portion being connectable to each other via an attachment mechanism associated with the reusable portion, the base station comprising:

a receptacle for holding the reusable portion of the infusion device, the receptacle including a member for cooperating with the reusable portion'"'"'s attachment mechanism; and

a recharger for recharging a battery in the reusable portion.

39. A base station according to claim 38, further including a communication interface between a separate computer and the reusable portion to upload information to or download information from the reusable portion.