Fluid delivery apparatus and method of making same

• US 5,656,032 A
• Filed: 05/26/1995
• Issued: 08/12/1997
• Est. Priority Date: 06/16/1989
• Status: Expired due to Fees

• Current Assignee: Pescadero Beach Holdings Corporation
• Original Assignee: Science Incorporated
• Inventors: Kriesel, Matthew, Feng, William, Kriesel, Marshall S., Kazemzadeh, Farhad, Kluck, William J., Barber, Steve C.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/451,520
• Time in Patent Office: 809 Days
• Field of Search: 604/48, 604/93, 604/131, 604/132, 604/151, 604/153, 604/890.1, 604/246, 128/DIG. 12
• US Class Current: 604/132
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• CPC Class Codes: A61M 2205/197 by the seal material
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14248 of the skin patch type
• 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: Y10S 128/12 Pressure infusion

Abstract

An apparatus for accurately infusing fluids into a patient at specific rates over an extended period of time and the method for making same. The apparatus includes one or more dispensers, of a low profile, laminate or layered construction each having a stored energy source in the form of a distendable membrane or an elastomeric cellular mass, which in cooperation with the base, defined a fluid chamber having a fluid inlet and a fluid outlet. The apparatus further includes, in lieu of a rigid ullage, a high novel, conformable ullage made of yieldable materials. The conformable ullage uniquely conforms to the shape of elastomeric membrane as the membrane returns to its less distended configuration. This arrangement will satisfy even the most stringent delivery tolerance requirements and will elegantly overcome the limitations of materials selection encountered in devices embodying the rigid ullage construction. Additionally, with the novel ullage construction, the ullage can be located either between the base and the fluid to be delivered, or alternatively, can be located between the elastomeric membrane and the fluid to be delivered. Further, a plurality of subreservoirs can be associated with a single ullage thereby making it possible to incorporate a wide variety of delivery profiles within a single device.

Claims

1. An ultra low profile device for use in infusing medicinal fluid into a patient at a controlled rate comprising:

(a) a base having an upper surface including a central portion, and a peripheral portion circumscribing said central portion and a lower surface engageable with the patient;

(b) stored energy means for forming in conjunction with said base, a reservoir having an outlet, said stored energy means comprising at least one distendable membrane superimposed over said base, said membrane being distendable as a result of pressure imparted by fluids introduced into said reservoir to establish internal stresses, said stresses tending to move said membrane toward a less distended configuration; and

(c) ullage-defining means disposed within said reservoir for engagement by said distendable membrane, said ullage-defining means comprising a mass substantially conformable to the shape of said distendable membrane as said membrane tends to move toward a less distended configuration.

2. A device as defined in claim 1 in which said mass comprises a gel.

3. A device as defined in claim 1 in which said mass comprises a fluid.

4. A device as defined in claim 1 in which said mass comprises an elastomer.

5. A device as defined in claim 1 in which said reservoir contains a medicinal fluid and in which said mass is disposed between said base and said fluid.

6. A device as defined in claim 1 in which said reservoir contains a medicinal fluid and in which said mass is disposed between said distendable membrane and said medicinal fluid.

7. A device as defined in claim 1 in which said base further includes a circuitous channel having first and second ends formed between said upper and lower surfaces a cannula having an inlet end disposed proximate said first end of said circuitous channel and in communication with said outlet of said reservoir and an outlet end provided in the form of a pierceable portion extending outwardly from said second end of said circuitous channel for insertion into the patient.

8. A device as defined in claim 7 in which said pierceable portion extends outwardly in a direction substantially perpendicular to said lower surface of said base for subdermal infusion of fluid into the patient.

9. A device as defined in claim 7 further including flow control means for controlling fluid flow through said cannula, said flow control means being disposed within a cavity formed in said base at a location between said fluid outlet of said reservoir and said inlet end of said cannula.

10. A device as defined in claim 9 in which said flow control means comprises a filter element for filtering the fluid flowing from said reservoir and a rate control element for controlling the rate of fluid flow outwardly of said pierceable portion of said cannula.

11. A device as defined in claim 10 in which said flow control means further includes a porous substrate for supporting said filter element and said rate control element, said porous substrate having a channel for receiving said inlet end of said cannula.

12. A fluid delivery device comprising:

(a) a base;

(b) stored energy means for forming, in conjunction with said base, a reservoir having an outlet, said stored energy storage means comprising at least one distendable member superimposed over said base, said member being distendable as a result of pressure imparted by fluids introduced into said reservoir to establish internal stresses, said stresses tending to move said member toward a less distended configuration;

(c) a conformable ullage disposed within said reservoir, said conformable ullage being substantially conformable with said distendable member as said member moves toward said less distended configuration; and

(d) an cutlet port for dispensing fluids from the device.

13. A device as defined in claim 12 in which said conformable ullage comprises a gel.

14. A device as defined in claim 12 in which said conformable ullage comprises a fluid.

15. A device as defined in claim 12 in which said conformable ullage comprises a cellular mass.

16. A device as defined in claim 12 in which said reservoir contains a medicinal fluid and in which said conformable ullage is disposed intermediate said distendable membrane and said medicinal fluid.

17. A device as defined in claim 12 in which said reservoir includes a plurality of subreservoirs each said subreservoir containing a different medicinal agent.

18. A device as defined in claim 17 in which said sub-reservoir are separated by a yieldable reservoir membrane.

19. A device as defined in claim 17 in which a selected one of said sub-reservoirs is separated from said conformable ullage by a yieldable membrane.

20. An ultra low profile device for use in infusing medicinal fluid into a patient at a controlled rate comprising:

(a) a thin base having an upper surface including a central portion and a peripheral portion circumscribing said central portion, a lower surface engageable with the patient and a channel formed in said base intermediate said upper and lower surfaces, said channel having first and second ends;

(b) stored energy means for forming in conjunction with said base, a reservoir having an outlet, said stored energy means comprising at least one distendable membrane superimposed over said base, said membrane being distendable as a result of pressure imparted by fluids introduced into said reservoir to establish internal stresses, said stresses tending to move said membrane toward a less distended configuration;

(c) ullage defining means comprising a conformable ullage disposed within said reservoir for engagement by said distendable membrane and for substantial conformance thereto as said membrane moves toward a less distended configuration;

(d) fluid flow control means supported by said base at a location proximate said first end of said channel for controlling fluid flowing from said reservoir;

(e) infusion means for infusing medicinal fluid from said fluid reservoir into the patient, said infusion means having an inlet end disposed proximate said first end of said channel and in communication with said fluid flow control means, said infusion means further including;

(i) a body portion disposed within said channel formed in said base; and

(ii) an outlet end provided in the form of a pierceable portion extending outwardly from said second end of said channel for insertion into the patient.

21. A device as defined in claim 20 in which said pierceable portion of said infusion means extends outwardly in a direction substantially parallel to said lower surface of said base for insertion into the vein of a patient for intravenous infusion of fluid.

22. A device as defined in claim 20 in which said pierceable portion of said infusion means extends outwardly in a direction substantially perpendicular to said lower surface of said base for subdermal infusion of fluid.

23. A device as defined in claim 20 in which said ullage-defining means comprises a protuberance formed on said central portion of said base and extending into said reservoir.

24. A device as defined in claim 20 in which said ullage-defining means comprises a yieldable mass that is substantially conformable to the shape of said distendable membrane as said membrane tends to move toward a less distended configuration.

25. A device as defined in claim 20 further including fluid inlet means for introducing fluid into said fluid reservoir, said fluid inlet means comprising a pierceable septum connected to said base.

26. A device as defined in claim 20 in which said flow control means is disposed within a cavity formed in said base at a location between said fluid outlet of said reservoir and said inlet end of said infusion means.

27. A device as defined in claim 26 in which said flow control means comprises a filter element for filtering the fluid flowing from said reservoir and a rate control element for controlling the rate of fluid flow outwardly of said pierceable portion of said infusion means.

28. A device as defined in claim 27 in which said flow control means further includes a porous substrate for supporting said filter element and said rate control element, said porous substrate having a channel for receiving said inlet end of said infusion means.

29. An ultra low profile device for use in infusing medicinal fluid into a patient at a controlled rate comprising:

(a) a base having an upper surface and a lower surface engageable with the patient and a circuitous channel formed in said base intermediate said upper and lower surfaces, said circuitous channel having first and second ends and an intermediate portion disposed therebetween;

(b) stored energy means for forming in conjunction with said base, a reservoir having an outlet, said stored energy means comprising at least one distendable membrane superimposed over said base, said membrane being distendable as a result of pressure imparted by fluids introduced into said reservoir to establish internal stresses, said stresses tending to move said membrane toward a less distended configuration; and

(c) infusion means for infusing medicinal fluid from said fluid reservoir into the patient, said infusion means comprising a circuitously shaped hollow cannula having;

(i) an inlet end portion disposed proximate said first end of said circuitous channel;

(ii) a non-linear central body portion disposed within said intermediate portion of said circuitous channel; and

(iii) an end portion having a first segment disposed proximate said second end of said channel and a second segment comprising a pierceable portion extending outwardly from said second end of said channel for insertion into the patient.

30. A device as defined in claim 29 in which said pierceable portion of said hollow cannula extends angularly outwardly from said non-liner central body portion of said hollow cannula.

31. A device as defined in claim 29 in which said pierceable portion of said hollow cannula extends substantially perpendicularly from said lower surface of said base.

32. A method of making a low profile device for use in infusing medicinal fluid into a patient at a controlled rate having a generally plate-like base provided with an upper surface including a central portion and a peripheral portion circumscribing the central portion, a distendable, elastomeric membrane superimposed over the base, and a cover engageable with the base to enclose the distendable membrane therewithin, the method comprising the steps of:

(a) gripping a peripheral portion of the distendable membrane in a manner to differentially stretch the membrane to produce a prestressed membrane;

(b) subsequent to stretching the membrane, urging the prestressed membrane into engagement with the upper surface of the base;

(c) emplacing the cover over the base and the prestressed membrane; and

(d) sealably interconnecting the presteresed membrane and the cover with the peripheral portion of the upper surface of the base.

33. A method as defined in claim 32 including the steps of sealably bonding the prestressed membrane to the peripheral portion of the upper surface of the base.

34. A method as defined in claim 32 including the further step of cutting the prestressed membrane as the cover is emplaced over the base.

35. A method as defined in claim 34 including following the step of cutting the prestressed membrane, sealably bonding the cover to the peripheral portion of the upper surface of the base.

36. A method of making a low profile fluid delivery device for use in infusing medicinal fluid into a patient at a controlled rate having a generally plate like base provided with an upper surface including a central portion and an upstanding tongue circumscribing the central portion, a distendable elastomeric membrane superimposed over the base, and a cover engagable with the base to enclose the distendable membrane therewithin, the cover having a groove within which the tongue of the base is closely receivable, the method comprising the steps of:

(a) stretching the distendable membrane to produce a prestressed membrane;

(b) urging the prestressed membrane into engagement with the upper surface of the base and into engagement with the upstanding tongue of the base;

(c) emplacing the cover over the base and the prestessed membrane such that the membrane is clamped between the tongue of the base and the groove of the cover;

(d) cutting the prestressed membrane at a location proximate the upstanding tongue of the base to provide a cut, prestressed membrane;

(e) sealably interconnecting the cut, prestressed membrane and the cover with the peripheral portion of the upper surface of the base.

37. A method as defined in claim 36 in which the cover is bonded to the base by sonic welding of the cover to the base at a location proximate the upstanding tongue of the base.

38. A method of making a low profile device for use in infusing medicinal fluid into a patient at a controlled rate having a base provided with an upper surface including a central portion and a peripheral portion circumscribing the central portion, a distendable, elastomeric membrane superimposed over the base, and a cover engageable with the base to enclose the distendable membrane therewithin, the method comprising the steps of:

(a) producing a prestressed membrane from a starting elastomeric membrane by the step of exerting forces on said starting elastomeric membrane in a manner to produce internal stresses therewithin to form a prestressed membrane;

(b) following the step of forming the prestressed membrane, placing the prestressed membrane over the upper surface of the base;

(c) emplacing the cover over the base and the prestressed membrane; and

(d) interconnecting the prestressed membrane and the cover with the base.