Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Thermal applicators
Reexamination Certificate
2001-11-06
2004-04-13
Gibson, Roy D. (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Thermal applicators
C607S096000, C607S113000
Reexamination Certificate
active
06719779
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates, in general, to a circulation set for a temperature-controlled catheter and, in particular, to a circulation set for a hypothermia catheter.
2. Background Information
Numerous catheters exist for non-invasive treatment of a variety of internal areas and regions of a patient. Many of these catheters circulate a fluid through a distal portion of the catheter. An example of a type of catheter that may circulate fluid through a distal portion of the catheter is a hypothermia catheter. A hypothermia catheter is inserted into the bloodstream of a patient in order to induce partial or total body hypothermia. A hypothermia catheter may be used to reduce the effects of certain bodily injuries to the brain as well as other organs. A hypothermia catheter may include a heat transfer element located at a distal portion of the catheter. A heat transfer fluid may be circulated along an internal portion of the heat transfer element, drawing heat from the heat transfer element. This, in turn, causes heat to be removed from blood flowing along an external surface of the heat transfer element, causing the resulting blood to be cooled. The collective components that supply fluid to the catheter and regulate the temperature of the fluid being delivered to and/or returning from the distal portion are referred to herein as the circulation set and may include one or more of the following: a fluid reservoir, a pump, a filter, a heat exchanger, a temperature sensor, a pressure sensor, and tubing.
The inventors of the present invention have recognized that as health insurance companies constantly cut back on the amount they are willing to pay for medical devices used in medical procedures, it important to produce a quality circulation set made of inexpensive components. Drawbacks of circulation sets in the past are that many or all of the components of the set are made of relatively expensive non-disposable components intended to be used numerous times before being disposed of, any disposable components of the circulation set are not conveniently separable from the non-disposable components, and the disposable components that are used are not made of readily-available cheap components. The inventors of the present invention have also recognized that it would be better for insurance reimbursement purposes if the circulation set was made of relatively inexpensive components and was essentially disposable.
SUMMARY OF THE INVENTION
A first aspect of the invention involves a single-use, disposable circulation set for a heat transfer catheter. The circulation set includes a single-use, disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter, a single-use, disposable pump adapted to pump heat transfer fluid through the catheter from the fluid reservoir, a single-use, disposable filter assembly adapted to remove impurities from the heat transfer fluid, a single-use, disposable heat exchanger member adapted for use with a heat exchanger for transferring heat between the heat exchanger and the fluid, a single-use, disposable temperature and pressure sensor block member for use with a multi-use, non-disposable temperature and pressure sensor electronics member, a single-use, disposable supply line communicating the fluid reservoir, pump, filter assembly, heat exchanger, and temperature and pressure sensor block member, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating the temperature and pressure sensor block member and fluid reservoir, and adapted to be connected to the catheter for returning heat transfer fluid to the fluid reservoir.
A second aspect of the invention involves a single-use, disposable circulation set for a catheter. The circulation set includes a single-use, disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter, a single-use, disposable heat exchanger member adapted for use with a heat exchanger for transferring heat between the heat exchanger and the fluid, a single-use, disposable temperature and pressure sensor block member for use with a multi-use, non-disposable temperature and pressure sensor electronics member, a single-use, disposable supply line communicating the fluid reservoir, heat exchanger, and temperature and pressure sensor block member, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating the temperature and pressure sensor block member and fluid reservoir, and adapted to be connected to the catheter for returning heat transfer fluid to the fluid reservoir.
A third aspect of the invention involves a single-use, disposable circulation set for a catheter. The circulation set includes a single-use, disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter, a single-use, disposable temperature and pressure sensor block member for use with a multi-use, non-disposable temperature and pressure sensor electronics member, a single-use, disposable supply line communicating the fluid reservoir and temperature and pressure sensor block member, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating the temperature and pressure sensor block member and fluid reservoir, and adapted to be connected to the catheter for returning heat transfer fluid to the fluid reservoir.
A fourth aspect of the invention involves a single-use, disposable circulation set for a catheter. The circulation set includes a single-use, disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter, a single-use, disposable heat exchanger member adapted for use with a heat exchanger for transferring heat between the heat exchanger and the fluid, a single-use, disposable supply line communicating the fluid reservoir and heat exchanger, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating with the fluid reservoir, and adapted to be connected to the catheter for returning heat transfer fluid to the fluid reservoir.
A fifth aspect of the invention involves a single-use, disposable circulation set for a catheter. The circulation set includes a single-use, disposable heat exchanger member adapted for use with a heat exchanger for transferring heat between the heat exchanger and the fluid, a single-use, disposable temperature and pressure sensor block member for use with a multi-use, non-disposable temperature and pressure sensor electronics member, a single-use, disposable supply line communicating the heat exchanger and temperature and pressure sensor block member, and adapted to be connected to the catheter for supplying heat transfer fluid to the catheter, and a single-use, disposable return line communicating with the temperature and pressure sensor block member, and adapted to be connected to the catheter for returning heat transfer fluid from the catheter.
A sixth aspect of the invention involves a method of using a circulation set for a heat transfer catheter. The method includes attaching a single-use, disposable circulation set including a fluid reservoir, a pump, a heat exchanger member, a condition sensor member, supply line, and return line to the catheter, circulating heat transfer fluid and controlling the temperature of the same through the catheter with the circulation set, and disposing the circulation set after a single use.
A seventh aspect of the invention involves a method of using a circulation set for a heat transfer catheter. The method includes providing a single-use, disposable circulation set for the catheter, the circulation set comprising a single-use, disposable fluid reservoir adapted to supply a heat transfer fluid to the catheter, a single-use, disposable pump adapted to pump heat transfer fluid through the catheter from the fluid r
Gibson Roy D.
Innercool Therapies, Inc.
Wieczorek Mark D.
LandOfFree
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