Fluid delivery device with conformable ullage

• US 5,735,818 A
• Filed: 10/11/1995
• Issued: 04/07/1998
• Est. Priority Date: 10/11/1995
• Status: Expired due to Fees

• Current Assignee: Pescadero Beach Holdings Corporation
• Original Assignee: Science Incorporated
• Inventors: Kriesel, Marshall S., Feng, William W., Kazemzadeh, Farhad, Kluck, William J., Kriesel, Matthew B., Barber, Steve C.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/541,183
• Time in Patent Office: 909 Days
• Field of Search: 604/131, 604/132, 604/151, 604/153, 604/246
• US Class Current: 604/132
• CPC Class Codes: A61M 2005/1581 Right-angle needle-type devices
• 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 5/152 pressurised by contraction of elastic reservoirs containers for dispensing contents by contraction of an elastic bag provided therein, in general B65D83/0061

Abstract

An apparatus for accurately infusing fluids into a patient at specific rates over an extended period of time. The apparatus is of a low profile, laminate or layered construction having a stored energy source in the form of a distendable membrane, which, in cooperation with the base of the apparatus, defines one or more fluid reservoirs, each having a fluid inlet and a fluid outlet. The apparatus further includes, a novel conformable ullage made of yieldable materials. The conformable ullage uniquely conforms to the geometry of elastomeric membrane as the membrane returns to its less distended configuration and in so doing can move between a central chamber and a toroidal chamber formed in the cover of the apparatus. This arrangement will satisfy even the most stringent medicament delivery tolerance requirements and will elegantly overcome the limitations of materials selection encountered in devices embodying solely a rigid ullage construction. Additionally, the infusion cannula of the apparatus is connected to the base in a novel manner which permits expeditious subdermal delivery to the patient via a cannula which extends generally perpendicularly relative to the base.

Claims

1. A 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, 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 central portion of said base, a reservoir having an inlet and 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) a cover connected to said base, said cover having a first chamber and a second chamber circumscribing said first chamber and at least one passageway interconnecting said first and second chambers, said distendable membrane overlaying said first and second chamber;

(d) a first conformable mass disposed within said first chamber for engagement by said distendable membrane;

(e) a second conformable mass disposed within said second chamber for engagement by said distendable membrane;

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

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

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

(iii) an end portion extending outwardly from said channel for insertion into the patient.

2. A device as defined in claim 1 in which said end portion of said hollow cannula extends outwardly in a direction substantially perpendicular to said lower surface of said base for subdermal infusion of fluid into the patient.

3. A device as defined in claim 1 further including flow control means in communication with said outlet of said reservoir for controlling the rate of fluid flow from said reservoir.

4. A device as defined in claim 1 in which a portion of said first conformable mass is urged from said first chamber of said cover through said passageway and into said second chamber of said cover as said distendable membrane is distended as a result of fluids being introduced into said inlet of said reservoir.

5. A device as defined in claim 1 in which said central portion of said base includes a convex surface.

6. A device as defined in claim 1 further including a barrier membrane connected to said central portion of said base, said barrier membrane being disposed intermediate said base and said distendable membrane and being distendable as a result of fluid being introduced into said inlet of said reservoir.

7. A device as defined in claim 1 further including sealing means for sealably connecting said distendable membrane to said base and to said cover.

8. A device as defined in claim 7 in which said base and said cover each have first and second radially spaced sealing grooves and in which said sealing means comprises first and second radially spaced base sealing protuberances formed on said distendable membrane and being sealably receivable within said sealing grooves formed in said base and first and second radially spaced cover sealing protuberances formed on said distendable membrane and being sealably receivable within said sealing grooves formed in said cover.

9. 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 generally spiral shaped 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 central portion of said base, a reservoir having an inlet and an outlet, said stored energy means comprising at least one distendable membrane superimposed over said base, said membrane having a central portion and a peripheral portion, said central portion being distendable from a first configuration to a second configuration as a result of pressure imparted by fluids introduced into said inlet of said reservoir to establish internal stresses, said stresses tending to move said membrane toward said first configuration;

(c) a cover connected to said base, said cover having a first chamber and a second chamber circumscribing said first chamber and a plurality of passageways interconnecting said first and second chambers;

(d) a first conformable mass disposed within said first chamber of said cover, said first conformable mass substantially conforming to the shape of said central portion of said distendable membrane as said central portion moves between said first and second configurations;

(e) a second conformable mass disposed within said second chamber of said cover for engagement by said peripheral portion of said distendable membrane; and

(f) infusion means for infusing medicinal fluid from said fluid reservoir into the patient, said infusion means having an inlet end disposed proximate said outlet of said fluid reservoir and including a hollow cannula having;

(i) a central body portion disposed within said generally spiral shaped channel; and

(ii) an outlet end portion including a pierceable portion extending angularly outward from said lower surface of said base for insertion in to the patient.

10. A device as defined in claim 9 further including sealing means for sealably interconnecting said distendable membrane with said cover and said base, said sealing means comprising radially spaced sealing protuberances formed on said distendable membrane.

11. A device as defined in claim 9 further including a yieldably deformable barrier membrane connected to said central portion of said base, said barrier membrane being disposed between said central portion of said base and said central portion of said distendable membrane.

12. A device as defined in claim 9 in which a portion of said first conformable mass is urged to flow from said first chamber of said cover through said plurality of passageways into said second chamber of said cover as said central portion of said distendable membrane distends toward said second configuration.

13. A device as defined in claim 12 in which said peripheral portion of said distendable membrane moves toward said base as said portion of said first conformable mass flows into said second chamber of said cover.

14. A device as defined in claim 13 further including vent means formed in said base for venting gases from said base as said peripheral portion of said distendable membrane moves toward said circumferentially extending concave surface of said base.

15. A device as defined in claim 13 in which said distendable membrane is bonded to said central portion of said base along the periphery thereof and along the center line thereof to define first and second barrier portions.