Fluid delivery device with bolus injection site

• US 5,925,017 A
• Filed: 12/16/1997
• Issued: 07/20/1999
• 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): Hirsch, Paul J.
• Application Number:
  US08/991,121
• Time in Patent Office: 581 Days
• Field of Search: 604/131, 604/132, 604/890.1, 604/133, 604/891.1, 128/DIG. 12
• US Class Current: 604/132
• CPC Class Codes: A61M 2005/14513 with secondary fluid driving or regulating the infusion
• 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 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• 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: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• 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. 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 which uniquely conforms to the shape of the elastomeric membrane as the membrane returns to its less distended configuration. 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, in one form of the invention, the infusion cannula of the apparatus is connected to the base of the apparatus in a novel manner which permits expeditious subdermal delivery of liquid medicaments to the patient via a cannula which extends generally perpendicularly from the base.

Claims

1. A low profile device for use in infusing medicinal fluids 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 and an intermediate portion disposed between said upper and lower surfaces;

(b) stored energy means for forming in conjunction with said base, first and second reservoirs, said first and second reservoirs having a fluid inlet and a fluid 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 first and second reservoirs to establish internal stresses, said stresses tending to move said membrane toward a less distended configuration;

(c) infusion means for delivering fluid from said first and second reservoirs to the patient, said infusion means comprising;

(i) an outlet port; and

(ii) a fluid passageway interconnecting said outlets of said first and second reservoirs with said outlet port; and

(d) bolus injection means in communication with said infusion means for delivering a bolus dose of medicinal to said infusion means.

2. A device as defined in claim 1 in which said fluid passageway is formed in said intermediate portion of said base.

3. A device as defined in claim 1 further including a cover connected to said base and covering said distendable membrane and in which said bolus injection means comprises an injection site mounted in said cover in communication with said fluid passageway.

4. A device as defined in claim 1 further including flow control means for controlling fluid flow from said first and second reservoirs.

5. A device as defined in claim 1 further including vent means for venting to atmosphere gases contained within said reservoir.

6. A device as defined in claim 1 further including ullage defining means for providing ullage within said first and second reservoirs.

7. A device as defined in claim 6 in which said ullage defining means comprises a flowable mass.

8. A device as defined in claim 6 in which said flowable mass comprises an oil.

9. A device as defined in claim 6 in which said flowable mass comprises an gel.

10. A device as defined in claim 6 in which said flowable mass comprises a gaseous material.

11. A device as defined in claim 6 in which said flowable mass comprises a polymer.

12. A device as defined in claim 6 in which said flowable mass comprises a viscous liquid.

13. A device as defined in claim 6 in which said flowable mass comprises a material selected from the group consisting of sodium palmitate, sodium sterate and methyl cellulose.

14. A device as defined in claim 6 further including a yieldably deformable barrier membrane disposed between said distendable membrane and said base.

15. A device as defined in claim 14 in which said barrier membrane comprises a material selected from the group consisting of polyurethane, polypropylene, polyethylene and fluorosilicon.

16. A fluid delivery device for use in the delivery of fluids to a patient at a controlled rate comprising:

(a) a base;

(b) stored energy means for forming in conjunction with 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) infusion means for delivering fluid from said reservoir to the patient, said infusion means comprising an outlet port and a fluid passageway interconnecting said outlet port with said outlet of said reservoir;

(d) bolus injection means in communication with said infusion means for providing a bolus volume of fluid to said infusion means; and

(e) ullage defining means for providing ullage within said reservoir, said ullage defining means being engageable by said distendable membrane and comprising a yieldable mass that is substantially conformable to the continually changing shape of said distendable membrane as said membrane tends to move toward a less distended configuration.

17. A fluid delivery device for use in connection with a syringe apparatus for infusing medicinal liquids 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 an intermediate portion disposed between said upper and lower surfaces;

(b) stored energy means for forming in conjunction with 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 liquids introduced into said reservoir to establish internal stresses, said stresses tending to move said membrane toward a less distended configuration;

(c) infusion means for infusing medicinal liquids from said fluid reservoir into the patient, said infusion means comprising an outlet port and a fluid passageway formed in said intermediate portion of said base said fluid passageway comprising a cannula having an end portion extending outwardly from said base;

(d) cover means connected to said base for covering said distendable membrane; and

(e) bolus injection means for providing a bolus liquid injection to the patient, said bolus injection means comprising an injection site provided in said cover, said injection site being in communication with said passageway of said infusion means.

18. A fluid delivery device for use in connection with a syringe apparatus for infusing medicinal liquids 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 an intermediate portion disposed between said upper and lower surfaces;

(b) stored energy means for forming in conjunction with 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 liquids introduced into said reservoir to establish internal stresses, said stresses tending to move said membrane toward a less distended configuration;

(c) infusion means for infusing medicinal liquids from said fluid reservoir into the patient, said infusion means comprising an outlet port and a fluid passageway formed in said intermediate portion of said base;

(d) cover means connected to said base for covering said distendable membrane;

(e) bolus injection means for providing a bolus liquid injection to the patient, said bolus injection means comprising an injection site provided in said cover, said injection site being in communication with said passageway of said infusion means; and

(f) ullage defining means for providing ullage within said reservoir, said ullage defining means being engagable by said distendable membrane and comprising a first flowable mass that is substantially conformable to the shape of said distendable membrane as said membrane tends to move toward a less distended configuration.

19. A device as defined in claim 18 in which said stored energy means forms in conjunction with said base a second reservoir having an inlet and an outlet.

20. A device as defined in claim 19 in which said infusion means is in communication with said outlet of said second reservoir.

21. A device as defined in claim 20 further including a second flow control means for controlling fluid flow from said second reservoir.