Portable instillation apparatus and method

• US 7,666,171 B2
• Filed: 10/28/2005
• Issued: 02/23/2010
• Est. Priority Date: 04/18/2002
• Status: Expired due to Fees

• Current Assignee: Haley's Pump Company
• Original Assignee: Haley's Pump Company
• Inventors: Mombrinie, Bruno, Eidsen, Cindy Carol, Eidsen, Jeff Brian, Davis, Robert, Peterson, Joe
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Eisenberg; Rebecca E
• Application Number:
  US11/163,758
• Publication Number:
  US 20080275381A1
• Time in Patent Office: 1,579 Days
• Field of Search: 604 401- 616, 604/31, 604/257, 604/259, 604/260, 604/264, 604/317, 604/540
• US Class Current: 604/257
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3386 Low level detectors
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 3/0202 with electronic control means or interfaces
• CPC Class Codes: A61M 3/0216 Pressure
• CPC Class Codes: A61M 3/0245 Containers therefor, e.g. with heating means or with storage means for cannula
• CPC Class Codes: A61M 3/0258 by means of electric pumps

Abstract

The present invention relates to an improved apparatus and method for instilling fluid into a patient having an intestinal stoma thereby administering an antegrade colonic enema. The portable instillation apparatus comprising in combination: a fluid reservoir, a pump assembly, a control module, a fluid delivery line and an intestinal stoma catheter wherein the control module is operable to automatically stop fluid delivery to the intestinal stoma after a predetermined volume of fluid has been instilled at a predetermined flow rate and pressure range suitable for a particular patient. The portable instillation apparatus incorporates a unique gear pump manifold facilitating the portability, durability and reliability of the apparatus overcoming the disadvantages of traditional peristaltic pump mechanisms. The portable instillation apparatus is so engineered as to maximize the ease of transport and use of the device while also enabling a method for a patient to self-administer an antegrade colonic enema within a short time period and without intervention.

Claims

1. A portable instillation apparatus for the purpose of pumping fluid into the intestinal tract through a stoma opening as presented by a patient, comprising,

a fluid reservoir having a top and a bottom suitable for holding instillation fluid, the bottom being a bulkhead,

a component chamber positioned below the fluid reservoir having a top and a bottom wherein the chamber top is formed from the fluid reservoir bulkhead,

a pump manifold assembly mounted to the fluid reservoir bulkhead and inside the component chamber having an inlet and an outlet with the inlet in direct fluid communication with the fluid reservoir and the outlet protruding upwardly through the bulkhead into the fluid reservoir but not in fluid communication with the reservoir,

a delivery tube being flexible and having a proximal and distal end with the proximal end in direct fluid communication with the pump manifold outlet,

a catheter suitable for insertion into a patient with an intestinal stoma constructed for purposes of instilling fluid into a patient'"'"'s intestines in direct fluid communication and removably attached to the distal end of the delivery tube,

a pump control module communicatively attached to the pump manifold assembly for purposes of activation and mounted in the component chamber,

a fluid level sensor mounted in the fluid reservoir operable to communicate the presence of fluid in the reservoir to the pump control module to which it is communicatively attached, the pump control module further being in direct electrical communication with a power supply;

and,

a user control interface module mounted proximate to the component chamber being in direct electrical communication with the pump control module.

2. The portable instillation apparatus of claim 1 wherein the pump manifold assembly further comprising further a gear pump having a pump motor, the gear pump being in direct fluid communication with the manifold assembly inlet and a fluid flow direction restrictor, the restrictor being operable to permit flow in a direction from the manifold inlet, the restrictor being in further, direct fluid communication with the manifold assembly outlet.

3. The portable instillation apparatus of claim 2 wherein the fluid flow direction restrictor comprises a load spring applying a preselected force between the body of the pump manifold assembly and a valve ball along the fluid communication pathway in the direction of the pump manifold assembly inlet, and a valve seat in the fluid communication pathway fixed to the pump manifold assembly thereby forming a seal between the valve ball and valve seat restricting the fluid flow in a direction from the inlet to outlet to flows exhibiting pressures sufficient to over come the preselected force of the load spring and stopping the fluid flow in a direction from the outlet to the inlet.

4. The portable instillation apparatus of claim 1 further comprising a lid assembly detachably inserted into the top of the fluid reservoir.

5. The portable instillation apparatus of claim 4 wherein the lid assembly further comprises a cover having a circumference length and radius, and an o-ring capable of being expanded and contracted in the circumference length by wedges constrained by the cover so as to slide inwardly and outwardly along the radius of the cover.

6. The portable instillation apparatus of claim 1 wherein the fluid reservoir is cylindrically shaped.

7. The portable instillation apparatus of claim 1 wherein the user interface module further comprises at least one operator control button in electrical connectivity with the pump control module for activating and deactivating the pump control module such that the pump control module is activated by a single assertion by the operator.

8. The portable instillation apparatus of claim 1 wherein the fluid level sensor is an optical fluid level sensor.

9. The portable instillation apparatus of claim 1 wherein the component chamber is constructed of transparent materials so as to permit viewing of the components inside the component chamber.

10. The portable instillation apparatus of claim 1 wherein the component chamber is constructed of optically low impedance reflective materials with sufficient transparency so as to permit viewing of the components inside the component chamber.

11. The portable instillation apparatus of claim 1 wherein the power supply is rechargeable batteries.

12. The portable instillation apparatus of claim 1 wherein the power supply is an external battery supply.

13. A method of using the portable instillation apparatus of claim 1 comprising the steps of, filling the reservoir with a flushing fluid, inserting the catheter suitable for insertion into a patient with an intestinal stoma, activating the apparatus, waiting for the apparatus to automatically deactivate, and removing the catheter from the patient.

14. A portable instillation apparatus for the purpose of pumping fluid into the intestinal tract through a stoma opening as presented by a patient, comprising,

a cylindrically shaped fluid reservoir having a top, a bottom and a fluid holding portion,

a circular bulkhead plate having a top and a bottom forming the bottom of the fluid holding portion of the reservoir and the top of an internal component chamber pressed and sealed into the inside circumference of cylinder of the fluid reservoir, the internal component chamber having a top and a bottom with bottom being a circular element inserted the inside circumference of the bottom of the cylinder of the fluid reservoir, thereby enclosing and protecting the chamber from fluid intrusion, the circular element further comprising a cavity accessible from the bottom of the element suitable for retaining a battery,

a pump manifold assembly mounted to the bottom of the bulkhead having an inlet and an outlet with the inlet in direct fluid communication with the fluid reservoir and the outlet protruding upwardly through the bulkhead into the fluid reservoir but not in fluid communication with the reservoir, the pump manifold assembly further comprises a gear pump having a pump motor, the gear pump being in direct fluid communication with the manifold inlet and a fluid flow direction restrictor, the restrictor being operable to permit flow in a direction from the manifold assembly inlet, the restrictor being in further, direct fluid communication with the manifold assembly outlet,

a delivery tube being flexible and having a proximal and distal end with the proximal end in direct fluid communication with the pump manifold outlet,

a catheter suitable for insertion into a patient with an intestinal stoma constructed for purposes of instilling fluid into a patient'"'"'s intestines in direct fluid communication and removably attached to the distal end of the delivery tube,

a pump control module communicatively attached to said gear pump motor suitable for activating the pump motor,

an optical fluid level sensor mounted in the bulkhead operable to communicate the presence of fluid in the reservoir to the pump control module to which it is communicatively attached, the pump control module further being in direct electrical communication with the battery,

a user interface module mounted to the cylinder proximate to the component chamber being in direct electrical communication with the pump control module;

and,

a lid assembly being generally circular is detachably inserted into the circumference of the top of the fluid reservoir.