Pressure monitoring to control delivery of therapeutic agent

• US 8,790,295 B1
• Filed: 01/04/2010
• Issued: 07/29/2014
• Est. Priority Date: 01/05/2009
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sigg, Daniel C., Hiniduma-Lokuge, Prasanga, Morris, Mary, Ujhelyi, Mike
• Primary Examiner(s): Bosworth, Kami A
• Application Number:
  US12/651,700
• Time in Patent Office: 1,667 Days
• Field of Search: 604 65- 67, 604/503, 604/505, 604/890.1, 604/891.1
• US Class Current: 604/67
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0076 Unidirectional valves
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00

Abstract

A method for adjusting delivery of a therapeutic fluid to a patient suffering from or at risk of pulmonary arterial hypertension includes introducing the therapeutic fluid to a patient via a catheter at a predetermined rate. The catheter is positioned to deliver the fluid to the right ventricle or the pulmonary artery. The catheter a one-way valve configured to allow the fluid to flow from the catheter to the target location. The method further includes monitoring pressure of the target location by monitoring internal catheter pressure, and adjusting the rate at which the therapeutic fluid is introduced to the catheter based on the monitored pressure. The rate at which the fluid is introduced to the catheter is increased if internal catheter pressure increases, and the rate at which the fluid is introduced to the catheter is decreased if the internal catheter pressure decreases.

Claims

1. A system comprising:

a catheter having a proximal end, a distal region including an opening, a lumen extending from the proximal end to the opening, and a one-way valve, the valve being disposed in proximity to the opening and configured to allow fluid to exit the lumen through the opening;

an infusion device having a housing, and a reservoir, an infusion mechanism, electronics and a pressure sensor disposed within the housing,

wherein the reservoir is configured to store therapeutic fluid,

wherein the infusion mechanism is configured to cause fluid from the reservoir to be infused through the lumen of the catheter when the catheter is operably coupled to the infusion device,

wherein the pressure sensor is configured and positioned such that the pressure sensor is capable of detecting pressure changes in the lumen of the catheter;

the pressure sensor being operably coupled to the electronics,

wherein the electronics are configured to control the rate that the therapeutic fluid is delivered from the reservoir to the lumen of the catheter and are configured to modify the rate of delivery based on intralumenal pressure detected by the pressure sensor,

wherein the rate of delivery is increased if the internal pressure of the catheter is increase, and the rate of delivery is decreased if the internal pressure of the catheter is decreased.

2. A system according to claim 1, wherein the infusion device is an implantable infusion device.

3. A system for delivering a therapeutic fluid to a patient suffering from or at risk of pulmonary arterial hypertension, the system comprising:

a catheter having (i) a proximal end, (ii) a distal delivery region configured to be implanted in a right ventricle or pulmonary artery of a patient, and (iii) a lumen extending from the proximal end to the delivery region, the delivery region comprising a one-way valve configured to allow fluid to flow from the lumen to outside the catheter; and

an implantable infusion device operably couplable to the catheter, the infusion device comprising

a reservoir for housing the therapeutic fluid,

an infusion mechanism for delivering the therapeutic fluid from the reservoir to the catheter,

a pressure sensor configured to measure internal pressure of the catheter when the catheter is operably coupled to the infusion device,

electronics operably coupled to the pressure sensor and the infusion mechanism, wherein the electronics are configured to compare internal pressure of the catheter at first and second times and are configured to adjust flow rate of fluid delivered to the catheter via the infusion mechanism in response to the measured internal pressure of the catheter, wherein the flow rate is increased if the internal pressure of the catheter is increased and flow rate is decreased if the internal pressure of the catheter is decreased.