Surgery – Diagnostic testing – Flexible catheter guide
Reexamination Certificate
2000-09-15
2002-01-08
Nasser, Robert L. (Department: 3736)
Surgery
Diagnostic testing
Flexible catheter guide
C600S434000
Reexamination Certificate
active
06336906
ABSTRACT:
The present invention relates to a sensor and guide wire assembly for intravascular pressure measurements having improved handling properties in the vessels in which it is to be inserted.
A sensor mounted on a guide wire suitable for use in intravascular pressure measurements is disclosed in International Patent Application No. WO 90/01294 and in U.S. Pat. No. Re. 35,648, and U.S. Pat. No. 5,715,827. One known sensor and guide wire assembly comprises a core wire having segments of varying thicknesses in at least the distal region of the core wire. In situations where it is desirable to attach a sensor having electrical leads connected thereto to the core wire, the core wire is enclosed in a tube, and the electrical leads run parallel inside the tube along the core wire. The core wire may, but need not, extend all the way to the proximal end of the tube. If the sensor is a pressure sensor, it is preferable to provide some sort of stiffening member for the sensor in order to avoid mechanical artifacts due to, for example, bending. It is known to provide a short, protective tube segment enclosing the sensor to stiffen and protect the sensor region of the guide wire. A stiffening member of this type has several limitations, however.
A first drawback of a protective tube segment, of the type indicated above, is that the formation of a joint between the coils and protective tube segment is difficult to make, and mismatch often occurs between coil and tube. Put another way, it is difficult to obtain good concentric matching.
A second drawback of a protective tube segment relates to the manufacturing process, which becomes more complicated because an additional structure, i.e., the protective tube segment, must be assembled as part of the sensor and guide wire assembly. A conventional means of attaching the protective tube segment to the sensor is with glue or another suitable adhesive, but this attachment method renders the joint non-optimal from a mechanical point of view. Further, the thermal expansion coefficient of the adhesive may differ from that of the materials used in the remaining components of the sensor and guide wire assembly, which can cause problems. The protective tube segment also makes the sensor region relatively stiff, and the length of the protective tube segment cannot be made as short as desirable.
A third drawback of a protective tube segment is that the tube segment constitutes an asymmetric and non-flexible or stiff portion that hinders bending at turns in a vessel.
A fourth drawback of a protective tube segment is that the inner diameter of the tube segment puts limitations on how the segmenting of the wire can be achieved.
The difficulties suggested in the proceeding are not intended to be exhaustive but rather are among many which tend to reduce the effectiveness and manufacturing efficiencies of conventional sensor and guide wire assemblies. Other noteworthy problems may also exist; however, those presented above should be sufficient to demonstrate that such assemblies appearing in the past will admit to worthwhile improvement.
SUMMARY OF THE INVENTION
Thus, there exists a need for a sensor and guide wire assembly having improved bending characteristics in the region of the sensor.
An object of the invention is therefore to provide a sensor and guide wire assembly that exhibits a smoother transition where the sensor element is placed and that is easier to produce from a manufacturing point of view.
A preferred embodiment of the invention, which is intended to accomplish the foregoing objects, includes a sensor and guide wire assembly having a mounting member. The mounting member preferably comprises an enlarged portion having a sensor receptacle or recess in which the sensor is mounted. This assembly yields an overall stiffer and mechanically robust device, without the drawbacks associated with a separate, protective tube segment as outlined in the above discussion of conventional devices. The assembly of the invention does not require a protective tube segment because the enlarged portion, having a sensor receptacle or recess formed therein, provides a protected mounting site for the sensor.
A sensor and guide wire assembly in accordance with the invention may comprise a core wire having a distal end, a proximal end, and a plurality of sections of different cross sections and different flexibilities. At least one of the sections has an enlarged portion, and the enlarged portion has a sensor receptacle therein. A tube encloses the core wire over at least a fraction of its length such that the core wire, including the enlarged portion, extends out from a distal end of the tube. The tube is configured to enable the sensor and guide wire assembly to be inserted into an artery and to be passed to a measurement site inside a patient's body. A sensor is mounted in the sensor receptacle of the enlarged portion of the core wire. A first coil is arranged to enclose a first portion of the core wire extending out from the distal end of the tube. The first coil is located nearer to the proximal end of the core wire than the sensor. A second coil is arranged to enclose a second portion of the core wire extending out from the distal end of the tube. The second coil is located nearer to the distal end of the core wire than the sensor. The first coil and the second coil each preferably have an outer diameter that is essentially the same as an outer diameter of the enlarged portion.
Additional objects and advantages of the invention will be set forth in the description that follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention may be realized and obtained by means of the instrumentalities and combinations particularly pointed out in the appended claims.
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Benkowski Per
Hammarström Ola
Tenerz Lars
von Malmborg Pär
Foley & Lardner
Marmor II Charles
Nasser Robert L.
Radi Medical Systems AB
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