Sheath and methods of ultrasonic guidance for biopsy and catheter insertion

• US 5,931,787 A
• Filed: 02/11/1997
• Issued: 08/03/1999
• Est. Priority Date: 02/11/1997
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Tetrad Corporation
• Inventors: Dietz, Dennis R., Ranalletta, Joseph V., Zimmermann, Eckehart
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US08/798,633
• Time in Patent Office: 903 Days
• Field of Search: 600/437, 600/461, 600/471, 604/197, 604/198
• US Class Current: 600/461
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2017/00336 with a protective sleeve, e.g. retractable or slidable
• CPC Class Codes: A61B 2017/3413 guided by ultrasound
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 8/0833 involving detecting or locating foreign bodies or organic structures
• CPC Class Codes: A61B 8/0841 for locating instruments
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/445 Details of catheter construction

Abstract

A sheath for receiving an ultrasonic probe and for defining the relative position of the probe with respect to a biopsy gun or a rigid needle is used for precise placement of the biopsy gun or needle tip in a structure. The sheath may comprise a keyhole-shaped slot for placement of a rigid needle through a puncture separate from a surgical port through which the sheath itself and the probe are introduced. A flexible catheter can thus be placed in a structure, using the ultrasonic probe to monitor its placement, followed by removal of the probe sheath and surgical port, leaving the catheter in place.

Claims

1. A sheath for being inserted into a patient'"'"'s body through a surgical port, said sheath receiving an ultrasonic probe and for guiding one of (1) a rigid elongated instrument inserted into said port parallel to said ultrasonic probe, or (2) a rigid elongated member inserted through a separate puncture, said sheath comprising a tubular member defining a lumen for receiving an ultrasonic probe and a rigid elongated instrument, and said sheath further defining an elongated keyhole-shaped slot aligned along the axis of said sheath and having a first portion too narrow to pass said rigid elongated member, terminating at a distal end of said sheath, and a second relatively wider portion spaced from said distal end of said sheath and wide enough to receive said rigid elongated member, said sheath further comprising means for retaining said instrument and said probe in defined parallel relation to one another and to said slot.

2. The sheath of claim 1, wherein said means for retaining said instrument and said probe in defined parallel relation to one another and to said slot comprises a plurality of pairs of protrusions extending inwardly from the outer surface of said sheath, said pairs of protrusions being located on either side of a line extending along the surface of said sheath and including the axis of elongation of said slot.

3. The sheath of claim 1, wherein said sheath is intended to be employed with an articulated probe, and said sheath comprises means for precluding contact between said probe and either of said rigid elongated instrument or said rigid elongated member.

4. The sheath of claim 3, wherein said means for precluding contact is a cut-out portion of the distal end of said tubular sheath opposite said slot, whereby said articulated probe can be bent only away from said slot.

5. A sheath for being inserted into a patient'"'"'s body through a surgical port, said sheath defining a lumen for receiving an ultrasonic probe and a keyhole-shaped slot for guiding a rigid elongated member inserted through a separate puncture, said keyhole-shaped slot being aligned along the axis of said sheath and having a first portion too narrow to pass said rigid elongated member, terminating at a distal end of said sheath, and a second relatively wider portion spaced from said distal end of said sheath and wide enough to receive said rigid elongated member, said sheath further comprising means for retaining said probe in defined relation to said slot.

6. The sheath of claim 5, wherein said keyhole-shaped slot is relatively elongated.

7. The sheath of claim 6, wherein the proximal end of said keyhole-shaped slot is juxtaposed to the distal end of an indentation formed in said tubular sheath.

8. The sheath of claim 5, wherein said means for retaining said probe in defined relation to said slot comprises a plurality of pairs of protrusions extending inwardly from the outer surface of said sheath, said pairs of protrusions being located on either side of a line extending along the surface of said sheath and including the axis of elongation of said slot.

9. The sheath of claim 5, wherein said sheath is intended to be employed with an articulated probe, and said sheath comprises means for precluding contact between said probe and said rigid elongated member.

10. The sheath of claim 9, wherein said means for precluding contact is a cut-out portion of the distal end of said tubular sheath opposite said slot, whereby said articulated probe can be bent only away from said slot.

11. A sheath for being inserted into a patient'"'"'s body through a surgical port, said sheath receiving an articulated ultrasonic probe and a rigid elongated instrument inserted into said port parallel to said ultrasonic probe, said sheath comprising a tubular member defining a lumen for receiving both of said probe and said instrument, means for retaining said probe and said instrument in predetermined radial relation to one another, and further comprising means for allowing said articulated ultrasonic probe to be bent in directions away from said instrument, while precluding said probe from being bent so as to come into contact with said instrument.

12. The sheath of claim 11, wherein said means for retaining said probe and said instrument in predetermined radial relation to one another comprises a plurality of pairs of protrusions extending inwardly from the outer surface of said sheath, said pairs of protrusions being located on either side of a line extending along the surface of said sheath for retaining said instrument in defined relation to said probe.

13. The sheath of claim 11, wherein said means for precluding contact is a cut-out portion of the distal end of said tubular sheath located with respect to said means for retaining said probe and said instrument in predetermined radial relation to one another such that said articulated probe can be bent only away from said instrument.

14. The sheath of claim 11, wherein said means for precluding contact comprises means on a handle portion of said instrument for limiting operation of said articulated probe.

15. In combination, an ultrasonic probe and a tubular sheath for being received in a lumen in a surgical port inserted into a patient'"'"'s body, said sheath having a lumen for receiving said ultrasonic probe, said sheath further defining a keyhole-shaped slot aligned along the axis of said sheath and terminating at a distal end of said sheath, said slot having a first portion too narrow to pass a rigid elongated member inserted into the body of a patient through a separate puncture, and a second relatively wider portion spaced from said distal end of said sheath and wide enough to receive said rigid elongated member, said sheath further comprising means for retaining said probe radially spaced from said slot.

16. The combination of claim 15, wherein said keyhole-shaped slot is relatively elongated.

17. The combination of claim 15, wherein the proximal end of said keyhole-shaped slot is juxtaposed to the distal end of an indentation formed in said tubular sheath.

18. The combination of claim 15, wherein said sheath is further adapted to receive a rigid elongated instrument inserted into said lumen of said sheath parallel to said ultrasonic probe.

19. The combination of claim 18, wherein said ultrasonic probe comprises an elongated cylindrical portion for extending through said surgical port and a handle portion external to said port containing operational controls, and said instrument also comprises an elongated cylindrical portion for extending through said surgical port and a handle portion external to said port containing operational controls, wherein said handle portions of said ultrasonic probe and said instrument cooperate with one another for convenient assembly thereof, such that the elongated cylindrical portions thereof are maintained in close parallel relation for conveniently fitting within the lumen of said sheath within said surgical port.

20. The combination of claim 19, wherein said handle portion of said ultrasonic probe comprises means for receiving the handle portion of said instrument such that flat surfaces thereof abut one another, and said cylindrical portion of said ultrasonic probe is offset with respect to said handle portion thereof, such that said flat surface of said handle portion of said ultrasonic probe is essentially tangent to the outer surface of said cylindrical portion thereof.

21. The combination of claim 19, wherein said cooperating handle portions of said instrument and said ultrasonic probe further comprise cooperating identification means, whereby salient characteristics of said instrument are communicated to said probe upon their assembly.

22. The combination of claim 21, wherein said instrument is a biopsy gun.

23. The combination of claim 22, wherein a salient characteristic of said biopsy gun communicated to said probe upon their assembly is a target distance for display on an associated video screen displaying objects in the field of view of said transducer.

24. The combination of claim 18, wherein said ultrasonic probe is controllably articulated, and said sheath comprises means for precluding contact between said probe and either of said instrument or said rigid elongated member.

25. The combination of claim 24, wherein said means for precluding contact is a cut-out portion of the distal end of said tubular sheath opposite said slot, whereby said articulated probe can be bent only away from said slot.

26. The combination of claim 24, wherein said means for precluding contact comprises means on a handle portion of said instrument for limiting operation of said articulated probe.

27. The combination of claim 26, wherein said transducer is rotatable about the axis of elongation of the tip of said probe, and said handle portion of said instrument comprises means for precluding said rotation when said instrument is assembled thereto.

28. The combination of claim 15, wherein said sheath comprises means for maintaining said probe and said instrument in defined physical relation to one another and to said slot.

29. The combination of claim 28, wherein said means for retaining said instrument and said probe in defined physical relation to one another and to said slot comprises a plurality of pairs of protrusions extending inwardly from the outer surface of said sheath, said pairs of protrusions being located on either side of a line extending along the surface of said sheath and including the axis of elongation of said slot.

30. The combination of claim 15, wherein said ultrasonic probe is controllably articulated, and said sheath is provided with means for precluding removal of said sheath from said surgical port if said probe is bent.

31. The combination of claim 30, wherein said means for precluding removal of said sheath from said surgical port if said probe is bent comprises a portion of said probe the diameter of which is increased when said probe is bent.

32. The combination of claim 15, wherein said probe is articulated, said probe comprising an operating handle containing a control apparatus for controlling the articulation of said probe, and wherein said sheath is keyed to said handle, such that said slot in said sheath bears a predetermined radial relation to said control apparatus.