Surgery – Instruments – Electrical application
Reexamination Certificate
1999-02-23
2001-02-27
Dvorak, Linda C. M. (Department: 3739)
Surgery
Instruments
Electrical application
C606S045000, C606S049000, C607S101000
Reexamination Certificate
active
06193714
ABSTRACT:
BACKGROUND
This invention relates generally to elongate medical devices insertable into the body, which are provided with optical viewing apparatus by which a remote site within the body near the distal extremity of the device can be seen from outside the body. Particularly, the invention relates to medical devices insertable into the body by way of a natural body opening, which are provided with optical viewing apparatus and with means, situated near the distal extremity and manipulable from the proximal extremity, for treatment of an internal organ. Such devices include for example transurethral catheter devices for treatment of the prostate.
Conventionally the distal extremity of such a device is introduced into the body and is maneuvered remotely, by manipulation of controls outside the body, to the site within the body that is to be observed and treated. Optical viewing apparatus in such devices typically provides for illumination of part of the region near (typically forward of) the distal extremity, and for conducting an image from the distal extremity to the proximal extremity, where the operator can view it.
Transurethral needle ablation devices having optical viewing capability and designed for treating the tissue of the prostate are described for example in U.S. Pat. Nos. 5,370,675; 5,366,490; and 5,435,805, and International Patent Publication No. WO 96/22739. The optical viewing apparatus in these devices facilitates positioning the distal extremity of the device at the appropriate site within the urethra, by illuminating the interior of the urethra and providing the operator with an image of the urethra wall as the distal extremity of the device is advanced within it toward the treatment site.
Many such procedures entail application of high-frequency electrical current, microwave energy, radio frequency energy, acoustical energy or laser energy to destroy cells in a target tissue. Significant damage to adjacent or surrounding tissues can result from application of the treatment if the treatment means is not precisely positioned before the ablating energy is applied. In a transurethral needle ablation procedure for treatment of the prostate, for example, when the needle electrode is pressed against the urethral wall the tip of the needle may fail to puncture the urethral wall, so that even when the needle is fully deployed it has not crossed into the prostate tissue. Application of electrical energy under these circumstances can result in severe traumna to the urethra.
Accordingly, in some disclosed devices, the optical viewing apparatus is additionally intended to address both a need to observe the progress of the distal extremity of the device to the treatment site, and a need to be able to view the treatment means while the treatment is in progress.
For example, U.S. Pat. No. 5,435,805 is directed to a device (such as a device for treatment of benign prostate hypertroplhy) having optical viewing capability for precise placement of the device which delivers the therapeutic energy into targeted tissues while minimizing effects on surrounding tissue. Particularly, U.S. Pat. No. 5,435,805 discloses a medical probe device having a stylet guide housing with at least one stylet port and means for directing a flexible stylet sideways out through the port into a target tissue, and a fiber optic viewing assembly, which has a viewing field extending forwardly and sidewardly of the guide housing to permit viewing of the stylet as it is deployed sideways from the distal extremity of the guide housing. To provide an unobstructed view of the emerging stylet, in some embodiments a portion of the material of the guide housing is removed to form a transverse depression behind the stylet port. However, the urethral wall is flabby, and tends to collapse into the depression, obscuring the view forward. In other embodiments the guide housing is provided with a window; but such an arrangement is difficult to manufacture and provides only limited visibility.
SUMMARY OF THE INVENTION
We have discovered that medical probe devices can be made with a capability for excellent viewing both during placement of the distal extremity of the device at the treatment site and during the progress of the treatment, by providing the distal extremity of the device with a transparent guide piece having a longitudinal bore within which the tip of an optical viewing element can be positioned. In a more forward position the visual field permits observation in a forward direction, particularly useful during placement of the device, as the distal extremity is directed toward the treatment site. In a more rearward position the visual field includes an image of a distal portion of the guide part, permitting observation of a distal portion of the guide piece and of its surroundings. The guide piece can additionally be provided with means for guided deployment of a treatment element (such as a stylet for application of radio frequency electrical energy, for example), and the optical viewing element can be positioned within the longitudinal bore in the transparent guide piece such that progress of deployment of the treatment element is within the visual field of the optical viewing element. Proper deployment of the treatment element is thus assured by direct observation.
In one general aspect, the invention features a medical probe device for introduction by way of a natural body opening into a tubular internal anatomical part of the body, including an elongate member having proximal and distal extremities and a passageway extending from the proximal extremity to the distal extremity along a longitudinal axis, a transparent guide piece mounted on the distal extremity of the elongate member, handle means mounted on the proximal extremity of the elongate member, and an optical viewing element movable within the passageway in the elongate member. The transparent guide piece has a bore therein defining a guide piece lumen in communication with the passageway in the elongate member and extending from the proximal extremity of the guide piece distally at least part way to the distal extremity of the guide piece. The optical viewing element has a distal extremity movable within the guide piece lumen, and the handle means carries means for mounting the distal extremity of the optical viewing element within the guide piece lumen and for moving the distal extremity of the optical viewing element in a longitudinal direction within the guide piece lumen between distal and proximal positions. The distal position provides a first visual field permitting viewing in a direction distal to the distal extremity of the guide piece, and the proximal position provides a second visual field permitting viewing in a direction lateral to at least the distal extremity of the guide piece
In some embodiments the guide piece additionally includes a stylet guiding channel having an opening on a surface of the guide piece, and the device additionally includes a stylet that is slidably movable in the stylet guiding channel. The handle means carries means for mounting the stylet within the stylet guiding channel and for slidably moving the stylet within the stylet guiding channel through the opening. The stylet guiding channel directs the stylet at an angle to the longitudinal axis of the elongate member as the stylet is slidably moved outward through the stylet guiding channel opening, and the distal extremity of the stylet is within the second visual field as the stylet emerges through the opening
In preferred embodiments the material of which the transparent guide piece is made has a refractive index in the range about 1.3 to about 1.7 and a luminous transmittance at least about 80% as determined using ASTM D 1003 procedures in a 0.3 mm thick specimen of the material. In some embodiments the transparent guide piece is made of transparent polymer material, which may be one or a combination of a polymer such as a polymethylmethacrylate, cellulose acetate, a polycarbonate, a polyurethane, or a polyethyleneterephthalate; or a glass.
In some embo
Depetrillo Bryan C.
Jones Christopher S.
McCullough Jack A.
McGaffigan Thomas H.
Dvorak Linda C. M.
Flehr Hohbach Test Albritton & Herbert LLP
Gibson Roy
Vidamed, Inc.
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