Surgery – Diagnostic testing
Reexamination Certificate
2001-03-28
2004-01-27
Marmor, Charles (Department: 3736)
Surgery
Diagnostic testing
C600S301000, C600S549000, C600S561000, C600S587000
Reexamination Certificate
active
06682480
ABSTRACT:
This invention relates to monitoring the treatment of human or non-human animals by means of implantable passive telemetric sensors. It is applicable to a variety of treatments but will be described hereinafter with particular reference to hyperthermia treatment, it being understood that the invention in not restricted to this type of treatment. Also, the induction will be described in relation to human patients, although it is to be understood that the monitoring involved may also be applied to non-human animals.
According to one aspect of the present invention, there is provided a method of monitoring the treatment of a human or non-human animal, which comprises implanting into the body of the human or non-human animal at or close to the desired locus of treatment a passive sensor which is adapted (a) to receive and to rectify an electromagnetic signal with a frequency of 1-2 GHz directed from outside the body towards the sensor so as to derive its operating power from maid electromagnetic signal, and (b) to transmit date relating to treatment parameters by wireless telemetry to a receiver external to the body of the human or non-human animal; and processing the data transmitted by said sensor to provide information on the treatment.
According to another aspect of the present invention, there is provided a device for implantation into the body of a human or non-human animal, which device comprises a passive sensor which is adapted (a) to receive and to rectify an electromagnetic signal with a frequency of 1-2 GHz directed from outside the body towards it and to derive its operating power from said electromagnetic signal, and (b) to transmit data relating to treatment parameters by wireless telemetry to a receiver external to the body of the human or non-human animal.
According do to a third a third aspect of the present invention, there is provided a system for monitoring the treatment of a human or non-human animal, which system comprises (a) a first component implanted into the body of the human or non-human animal at or close to the site of treatment; and (b) a second component in the form of a unit external to the body of the human or non-human animal,
characterized in that:
(A) said first component comprises an antenna, rectification circuitry and signal processing circuitry;
(B) said second comprises is a microwave source, a receiver, a transmit/receive antenna and control circuitry for controlling the operation of the unit; and
(C) said first component is arranged:
(a) to receive and rectify an electromagnetic signal with a frequency of 1-2 GHz transmitted by the antenna of said second component and to derive its operating power from said electromagnetic signal, and
(b) to transmit data relating to treatment parameters by wireless telemetry to said second component; and
(D) said second component is arranged to transmit an electromagnetic signal with a frequency of 1-2 GHz towards said first component and to interrogate said first component to derive therefrom data pertaining to the treatment which human or non-human animal is undergoing.
In one particular embodiment of the invention, the sensor is a miniature pressure sensor; this may, for example, be associated with a stent whose function is to maintain the lumen patency of a duct, vessel or organ. Such devices may be employed at many sites within the body and may provide valuable information during the treatment of a wide range of conditions. The sensor may, for example, be incorporated in a transjugular intrahepatic portosystemic shunt (TIPS) or in a stent within the renal artery.
The desired locus of treatment may be, for example, a tumour; a blood vessel (for example, where levels of circulating species, or general flow rates, are to be monitored); or a duct, e.g. the pancreatic duct or bile duct. Many other loci exist and will naturally be determined according to the needs of the patient.
preferably, the sensor is associated with a therapeutic device which is also implanted into the human or non-human animal body in the method of this invention. Non-limiting examples of the implanted therapeutic device include:
a device for delivering heat in a localised manner, e.g. to treat a tumour;
pump for assisting blood flow;
a stent for ensuring lumen patency of hollow viscera and ducts, e.g. oesophagus, bile duct, pancreatic duct, colon, stomach, rectum and urethra;
a pressure sensor for detecting localised pressures, e.g. within a stent of the type just mentioned;
a flow meter for determining passage of a fluid through a duct;
a drug release device;
a pacemaker;
a detector for particular chemical or biological material or species, e.g. blood or tissue chemical content or cellular content;
or combinations of such devices.
Localised heating can be of benefit in several situations, for example: (a) to stop bleeding, e.g. of a tumour or in a non-malignant condition such as benign ulcers of the stomach or duodenum. The therapeutic device may thus be an electrode or an assembly of electrodes which can be activated (preferably remotely) so as to generate localised heating of adjacent tissues. An electrode of this sort may, for example, be positioned around a tumour of the prostate, colon, bladder, stomach or lung; it may likewise be positioned adjacent to a duodenal or stomach ulcer.
The invention also finds application in surgical procedures involving balloon dilatation and/or coronary stenting. These surgical procedures tend to encourage the formation of fibrous tissue which can lead to stenosis, e.g. blockage of a blood vessel after removal of the dilatation equipment. In accordance with this invention, such dangers of stenosis may be removed or mitigated by heating the stent during a coronary stenting procedure or by applying heat adjacent to a region undergoing balloon dilatation. Control of the heating process is assisted by sensing the temperature of the heated component.
The sensor associated with the therapeutic device will be configured to respond to a parameter (e.g. temperature, flow rate, pressure) which is of significance in the treatment regime being followed. Thus in the treatment of a tumour by hyperthermia, the parameter sensed may be temperature; and in the treatment of an occluded duct, the parameter sensed may be pressure.
The transmission of data from within the body to an external receiver may be accomplished using low power radiation in the radio frequency or microwave frequency bands. Such transmission is preferably intermittent rather than continuous and will generally be under the control of medical personnel or, in the case of a human patient of the patient him/herself.
Advantageously, the sensor (and the therapeutic device also, if this requires electrical power to operate is/are empowered by wireless means. While in some instances batteries may be implanted as a power source, this is not preferred; the currently preferred mode of delivery is by means of an implanted antenna/rectifier device (a so-called “rectenna”) which receives electromagnetic radiation from an external source and delivers electrical power derived therefrom. Typically, the power levels involved for sensor applications are less than about 1 mW; at these levels, the antenna portion of the rectenna can be implemented as a filamentary coil-shaped antenna for low frequencies or as a short dipole antenna for high frequencies. A chip-sized (typically less than 1 mm
3
) rectifying circuit comprising a combination of rectifying diodes, a storage capacitor and (optionally) a filter circuit is mounted on the antenna. Typically, the sensor/rectenna combination occupies a volume of around 60 mm
3
or less.
Electromagnetic radiation at a frequency of 1-2 GHz and with a power density of 1 mW/cm
2
will provide such a rectenna with adequate operating power. This may advantageously be provided by an external transmit/receive unit which will direct electromagnetic radiation towards the implanted rectenna in order to power up and interrogate the sensor electronics. Such a unit will operate in a duplex fashion, simultaneously transmitting the pow
Habib Nagy Adly
Sangster Alan John
Imperial College Innovations Limited
Marmor Charles
Oppenheimer Wolff & Donnelly LLP
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