Surgery – Diagnostic testing – Structure of body-contacting electrode or electrode inserted...
Reexamination Certificate
1999-12-27
2002-04-09
Layno, Carl (Department: 3737)
Surgery
Diagnostic testing
Structure of body-contacting electrode or electrode inserted...
C600S373000, C607S115000
Reexamination Certificate
active
06370411
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to systems for medical diagnosis and treatment, and specifically to medical catheters whose location can be detected.
BACKGROUND OF THE INVENTION
Various methods and devices have been described for determining the position of a probe or catheter tip inside the body using electromagnetic fields, such as in U.S. Pat. No. 5,042,486 and PCT patent publication WO 94/04938, whose disclosures are incorporated herein by reference. Other electromagnetic tracking systems, not necessarily for medical applications, are described in U.S. Pat. Nos. 3,644,825, 3,868,565, 4,017,858, 4,054,881 and 4,849,692, whose disclosures are likewise incorporated herein by reference.
U.S. Pat. No. 5,391,199, whose disclosure is incorporated herein by reference, describes a system that incorporates a catheter, which includes a position measuring device that can determine the position of the catheter in three dimensions, but not its orientation.
PCT patent application PCT/WO96/05768, which is assigned to the assignee of the present patent application and whose disclosure is likewise incorporated herein by reference, describes a catheter system including means for determining the six-dimensions of position and orientation of the catheter's distal tip. This system uses a position sensor, formed of a plurality of non-concentric coils, adjacent to a locatable site in the catheter, for example near its distal tip. Preferably three orthogonal coils are used. These coils generate signals in response to externally applied magnetic fields, which allow for the computation of six position and orientation coordinates, so that the position and orientation of the catheter are known without the need for imaging the catheter.
U.S. Pat. No. 4,580,557 describes a surgical laser system for connection to various peripheral surgical devices. The system identifies to which device it is connected according to characteristics of a signature resistor embedded within the device. The resistor uniquely identifies the device in which it is embedded.
U.S. Pat. No. 5,383,874 describes a system for identifying and monitoring catheters, including identification means carried within the handle of the catheter body. In one embodiment of the catheter in this patent, the handle includes a solid-state microchip pre-programmed with a digital value representing an identification code and other operational and functional characteristics of the catheter. The handle is connected by a cable to a control console, which receives data from the microchip. In one disclosed embodiment, the microchip may record the number of times the catheter has been used.
U.S. Pat. No. 5,617,857 describes an imaging system which determines the location of a medical instrument. A read-only storage device is positioned on or in the medical instrument for storing initialization information characteristic of the instrument. Thus, the system may determine the type of the instrument connected thereto, and receive initialization information associated with the instrument type. This patent further suggests preventing use of the instrument unless the initialization information was transferred from the storage device to the imaging system. A verification method is also described in which the initialization information is verified for correctness. Two alternatives are suggested for the location of the storage device. One alternative suggests embedding the device directly in the instrument. A second alternative suggests embedding the storage device within an attachment, essentially an instrument handle, to which a certain type of instrument may be fit.
Thus, in some of the embodiments described in the above-referenced patents, information regarding a catheter (or other medical tool) is stored in an attachment to the catheter and not in the catheter itself. These embodiments are not suitable for storing item-specific information such as calibration information.
In other embodiments of the above-referenced patents, information is stored in the catheter. These embodiments, however, suffer from over-complexity, requiring for example multiple digital signal wires to run along the catheter. This complexity is not feasible for mass use in disposable catheters.
SUMMARY OF THE INVENTION
It is an object of some aspects of the present invention to provide means for convenient electronic storage and recall of calibration information regarding a catheter.
It is another object of some aspects of the present invention to provide means for convenient electronic storage and recall of calibration information regarding a catheter, in which the recall time of the information is minimal.
It is another object of some aspects of the present invention to provide means for providing improved communication between the catheter and a control console.
It is a further object of some aspects of the present invention to provide catheters of minimal cost and complexity, which are capable of storing and recalling calibration information.
In one aspect of the present invention, a catheter assembly for connection to a control console comprises two parts: a catheter of minimal complexity which is inserted into a patient's body, and a connection cable which connects between the proximal end of the catheter and the console. The catheter comprises a microcircuit which carries substantially only information specific to the catheter, which is not in common with other catheters of the same model. Such information includes, for example, item-specific calibration data and a date of first use of the catheter. The cable comprises an access circuit which receives the information from the catheter and passes it in a suitable form to the console.
Preferably, the cable operates with all catheters of a specific model or type, and therefore when a catheter is replaced, there is no need to replace the cable. Particularly, catheters which are planned for one-time use do not require replacement of the cable, which does not come in contact with patients.
In a preferred embodiments of the present invention, the access circuit verifies that the catheter is of the model which is compatible with the cable. Preferably, the connection between the catheter and the cable is unique for each catheter model. Alternatively or additionally, the model identification is stored in the microcircuit and the access circuit verifies that the model identification is the same in the cable and the catheter.
In some preferred embodiments of the present invention, each cable is associated with a few catheters models, and the model identification stored in the microcircuit is used by the access circuitry to identify which catheter model is in use.
In some preferred embodiments of the present invention, the catheter microcircuit contains data which is stored digitally. Preferably, the leads of the microcircuit are coupled directly to sockets in a receptacle at the distal end of the cable. Thus, the catheter does not contain digital signal wires, and still allows quick access to the information in the microcircuit. Also, digital electronic signals transmitted from the microcircuit to the console via the cable do not interfere with low-level analog signals conveyed by wires from the distal end of the catheter to the cable. Preferably, the access circuit is located within the receptacle at the distal end of the cable and includes the socket which receives the leads of the microcircuit.
In preferred embodiments of the present invention, the microcircuit stores minimal calibration and/or initialization information regarding the catheter. Alternatively or additionally, the microcircuit stores usage information regarding the catheter, such as the date of first use of the catheter.
In preferred embodiments of the present invention, the catheter comprises at its proximal end a handle which contains controls which are used to manipulate the catheter. It is noted that in catheters in which the handle is not at the proximal end of the catheter, the length beyond the handle does not add to the functional
Matcovitch Avraham
Osadchy Daniel
Biosense Inc.
Capezzuto Louis J.
Layno Carl
LandOfFree
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