Surgery – Diagnostic testing – Cardiovascular
Reexamination Certificate
1998-07-20
2001-04-24
Nasser, Robert L. (Department: 3736)
Surgery
Diagnostic testing
Cardiovascular
C600S488000
Reexamination Certificate
active
06221024
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a body implantable pressure sensor attached to an endocardial lead for implantation in a heart chamber or cardiac blood vessel for sensing blood pressure and providing blood pressure signals to an implanted or external hemodynamic monitor and/or therapy delivery device and method of fabrication thereof.
DESCRIPTION OF THE BACKGROUND ART
Efforts have been underway for many years to develop implantable pressure transducers and sensors for temporary or chronic use in a body organ or vessel and systems for recording absolute pressure. Many different designs and operating systems have been proposed and placed into temporary or chronic use with patients. Indwelling pressure sensors for temporary use of a few days or weeks are available, and many designs of chronically or permanently implantable pressure sensors have been placed in clinical use.
U.S. Pat. No. 4,023,562 describes a pressure transducer comprising a piezoresistive bridge of four, orthogonally disposed, semiconductor strain gauges formed interiorly on a single crystal silicon diaphragm area of a silicon base. A protective silicon cover is bonded to the base around the periphery of the diaphragm area to form a sealed, evacuated chamber. Deflection of the diaphragm due to ambient pressure changes is detected by the changes in resistance of the strain gauges. Because the change in resistance is so small, a high current is required to detect the voltage change due to the resistance change. The high current requirements render the piezoresistive bridge unsuitable for long term use with an implanted power source. High gain amplifiers that are subject to drift over time are also required to amplify the resistance-related voltage change.
Other semiconductor pressure transducers employ CMOS IC technology in the fabrication of pressure responsive silicon diaphragm bearing capacitive plates that are spaced from stationary plates. The change in capacitance due to pressure waves acting on the diaphragm is measured, typically through a bridge circuit, as disclosed, for example, in the article “A Design of Capacitive Pressure Transducer” by Ko et al., in
IEEE Proc. Symp. Biosensors,
1984, p. 32. Again, fabrication for long term implantation and stability is complicated. In addition, differential capacitive plate, fluid filled pressure transducers employing thin metal or ceramic diaphragms have also been proposed for large scale industrial process control applications as disclosed, for example, in the article, “A ceramic differential-pressure transducer” by Graeger et al.,
Philips Tech. Rev.,
43:4:86-93, February 1987. The large scale of such pressure transducers does not lend itself to miniaturization for chronic implantation.
Piezoelectric crystal or piezoresistive pressure transducers mounted at or near the distal tips of pacing leads, for pacing applications, or catheters for monitoring applications, are described in U.S. Pat. Nos. 4,407,296, 4,432,372, 4,485,813, 4,858,615, 4,967,755, and 5,324,326, and PCT Publication No. WO 94/13200, for example. The desirable characteristics and applications for patient use of such lead or catheter bearing, indwelling pressure sensors are described in these and other patents and the literature in the field. Generally, the piezoelectric or piezoresistive transducers have to be sealed hermetically from blood.
The '296 patent discloses sealing the piezoresistive bridge elements within an oil filled chamber having a deflectable diaphragm so that blood pressure fluctuations can deflect the diaphragm and be transmitted by the oil to the pressure transducer. In one embodiment disclosed therein, a sealed inner chamber at a calibrated pressure is provided on one side of the piezoresistive bridge transducer, and the oil bears against the other side of the transducer. The incompressible oil is admitted into the chamber through a fill tube in a vacuum filling process to fill the chamber between the transducer and the diaphragm. The fill tube is then crimped.
The crimping of the end of the fill tube is not necessarily sufficient to prevent leakage of the oil from the chamber. Such pressure sensor leads are intended to be chronically implanted in patients for years or decades. The function of the pressure transducer will be impaired if the oil leaks from the chamber and is displaced by air or body fluids over such a period of time.
Moreover, the configuration of the pressure transducer housing employed in the '296 patent locates the diaphragm perpendicular to the lead body axis and facing distally. This constitutes a bulky transducer module and prevents its use at a location more proximal to the distal end of the lead body.
Despite the considerable effort that has been expended in designing such pressure sensors, a need exists for a body implantable, durable, long-lived and low power consuming pressure sensor for accurately sensing absolute pressure waves in the body over many years and for deriving body temperature signals in a system for demodulating and storing the signals.
SUMMARY OF THE INVENTION
It is therefore an object of the present invention to provide an improved method for sealing oil filled pressure transducer modules for a chronically implantable pressure sensor lead.
The present invention involves a body implantable pressure sensor attached to an endocardial lead for implantation in a heart chamber or cardiac blood vessel for sensing blood pressure and providing blood pressure signals to an implanted or external hemodynamic monitor and/or therapy delivery device and method of fabrication thereof. A pressure sensor module is formed of an elongated receptacle having an elongated receptacle cavity for receiving a calibrated, micro-machined pressure transducer having a pressure responsive element. The receptacle cavity is covered by a diaphragm disposed alongside the lead body and in parallel with the lead axis. The receptacle cavity is filled with a incompressible oil for transferring pressure forces that are applied to the diaphragm to the pressure transducer. The oil is introduced through a fill port, and the fill port is sealed after the oil is introduced to prevent leakage of the oil from the receptacle cavity and to complete the hermetic sealing of the receptacle cavity. In one embodiment, the fill port comprises a fill tube having a fill tube lumen extending outward of an end wall of the receptacle cavity to a fill tube end, and said sealing step further comprises the steps of crimping the fill tube end to close the fill tube lumen, fitting a fill port cover having an abutting edge over the crimped fill tube end and against the end wall of the receptacle to enclose the crimped fill tube end within a fill port cover cavity, and sealing the abutting edge against the receptacle end wall to hermetically enclose the sealed fill tube end within the fill port cover cavity.
In another embodiment, the fill port is formed with a tapered fill port lumen and is closed by a stopper pressed into it to close or block the fill port lumen and inhibit leakage of oil therethrough. The closed fill port is then enclosed within the fill port cover in the same manner.
Moreover, the fill tube lumen can be tapered and receive a stopper and these closure techniques can be combined.
The crimping or blocking of the fill tube does not over-pressurize the oil within the receptacle cavity. In addition, the sealing of the abutting edge against the receptacle obviates the need for welding of the crimped or blocked fill tube end. The welding energy applied to the fill tube end can overheat the oil within the receptacle cavity that can result in expansion of the oil and damage to the pressure transducer and/or to the receptacle and diaphragm or explosion of the oil from the receptacle cavity in extreme cases.
REFERENCES:
patent: 3939823 (1976-02-01), Kaye et al.
patent: 4023562 (1977-05-01), Hynecek
patent: 4407296 (1983-10-01), Anderson
patent: 4432372 (1984-02-01), Monroe
patent: 4485813 (1984-12-01), Anderson et al.
patent: 4610256 (1986-09-01), Walla
Atlass Michael B.
Medtronic Inc.
Nasser Robert L.
Patton Harold R.
LandOfFree
Implantable pressure sensor and method of fabrication does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Implantable pressure sensor and method of fabrication, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Implantable pressure sensor and method of fabrication will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2439109