Title:
Add-On For Invasive Probe
Kind Code:
A1


Abstract:
An invasive probe assembly including an invasive probe having a surface area and a tool carrier removably mounted on the invasive probe, including a substrate having an area smaller than 25% of the surface area of the probe and at least one tool mounted on the substrate. The layout of the substrate or of one or more of the at least one tool is optionally substantially different in different sectors of the circumference of the probe.



Inventors:
Hadani, Ron (Cresskill, NJ, US)
Application Number:
11/791985
Publication Date:
10/16/2008
Filing Date:
12/01/2005
Primary Class:
International Classes:
A61B5/042
View Patent Images:
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Primary Examiner:
ANTISKAY, BRIAN MICHAEL
Attorney, Agent or Firm:
MARTIN D. MOYNIHAN d/b/a PRTSI, INC. (Fredericksburg, VA, US)
Claims:
1. An invasive probe assembly, comprising: an invasive probe having a surface area; and a tool carrier removably mounted on the invasive probe, including a substrate having an area smaller than 25% of the surface area of the probe and at least one tool mounted on the substrate, wherein the layout of the substrate, or of one or more of the at least one tool is substantially different in different sectors of the circumference of the probe.

2. An assembly according to claim 1, wherein the substrate has a width shorter than 3 cm, measured in an axial dimension of the invasive probe.

3. An assembly according to claim 2, wherein the substrate has a width shorter than 1 cm.

4. An assembly according to claim 1, wherein the substrate substantially entirely surrounds the circumference of the probe.

5. An assembly according to claim 1, wherein the substrate is attached to the probe by an adhesive.

6. An assembly according to claim 1, wherein the substrate includes a protective electrical or heat isolating layer, which is located between the tool and the probe.

7. An assembly according to claim 1, wherein the at least one tool comprises an electrode.

8. An assembly according to claim 7, wherein the substrate is electrically conductive, serving as a part of the electrode.

9. An assembly according to claim 7, wherein the at least one tool comprises only a single electrode.

10. An assembly according to claim 1, wherein the substrate is electrically isolative.

11. An assembly according to claim 1, wherein the at least one tool comprises at least one sensor and at least one electrode.

12. An assembly according to claim 1, comprising a protective sheath that covers the probe and wherein the substrate is mounted on the protective sheath.

13. An assembly according to claim 1, wherein the substrate does not cover a distal 5 mm portion of the probe.

14. An assembly according to claim 1, wherein over most of the length of the substrate, the substrate covers less than 20% of the circumference of the probe.

15. An assembly according to claim 1, wherein the tool comprises a flat electrode and wherein attaching the electrode to the probe increases the cross-section diameter of the probe by less than 2 millimeters.

16. An assembly according to claim 1 wherein the tool comprises an electrode which conforms to the shape of the probe.

17. An assembly according to claim 1, wherein the tool carrier is flexible.

18. An assembly according to claim 17, wherein the tool carrier is more flexible than the invasive probe.

19. An assembly according to claim 1, wherein the tool carrier includes a wire electrically coupled to the tool and extending to a proximal end of the probe.

20. An assembly according to claim 19, comprising the wire is fastened to the probe using a ring at a proximal side of the probe.

21. 21-76. (canceled)

Description:

RELATED APPLICATIONS

This application claims the benefit under 119(e) of U.S. provisional patent application 60/632,739, titled “Add on Electrode for Endoscope”, filed Dec. 1, 2004, U.S. provisional patent application 60/653,135, titled “Endoscopic Sheath with Illumination System”, filed Feb. 16, 2005, and U.S. provisional patent application 60/669,007, filed Apr. 7, 2005, titled “Emergency Electrode on Medical Tube”. The disclosures of all of these applications are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to apparatus for minimally invasive procedures and particularly to electrodes to be used in such procedures.

BACKGROUND OF THE INVENTION

Endoscopes and other invasive probes are used to view internal tissue of humans, and for many other tasks.

U.S. Pat. No. 4,354,502 to Colley et al., the disclosure of which is incorporated herein by reference, describes a catheter having an ultrasound transducer and an ECG electrode built into the catheter.

Not all catheters and endoscopes are constructed with an integral electrode. In some cases it is desired to add an electrode to an existing endoscope or probe.

U.S. Pat. No. 6,394,949 to Crowley et al., the disclosure of which is incorporated herein by reference, describes a removably attachable electrode housing for mounting on a distal end of an endoscope. Electrodes of the housing are used for ablation. The U.S. Pat. No. 6,394,949 refers to prior art attempts to mount electrodes on expandable surfaces, such as balloons, delivered through an accessory channel of the endoscope.

U.S. patent publication 2002/0177847 to Long, the disclosure of which is incorporated herein by reference, describes an ablation cap for mounting on the distal end of an endoscope. The ablation cap includes two electrodes which are positioned along the side of the endoscope at its distal end. The electrodes are connected to the proximal end of the endoscope via wires which are wrapped around the endoscope or are attached along its length using connectors.

U.S. patent publication 2002/0198583 to Rock et al., the disclosure of which is incorporated herein by reference, describes a disposable sheath for a transesophageal electrocardiography (TEE) ultrasound probe or for an endoscope, which has a conductor integrated into the sheath, so as to be located along the axial length of the probe.

U.S. Pat. No. 5,588,432 to Crowley, the disclosure of which is incorporated herein by reference, describes ring ablation electrodes mounted on a disposable catheter sheath.

U.S. Pat. No. 5,830,146 to Skaldnev et al., the disclosure of which is incorporated herein by reference, describes a sheath cover of a diagnostic probe that includes electrodes in its distal tip.

U.S. Pat. No. 6,517,530 to Kleven, the disclosure of which is incorporated herein by reference, describes a sleeve for adding an auxiliary element (e.g., an electrode) to an endoscope. The sleeve surrounds the endoscope over a substantial part of its length and carries on it the auxiliary element.

These sheaths are relatively large and may interfere with the insertion of the endoscope into the patient and/or its use therein.

U.S. Pat. Nos. 5,191,885 to Bilof et al. and 5,069,215 to Jadvar et al., the disclosures of which are incorporated herein by reference, describe a single use disposable esophageal electrode structure in the form of a sheet to be wrapped around an esophageal probe. The sheet is described as having a length dimension of the order of between 50-200 millimeters and a width dimension of the order of 40 millimeters.

PCT publication WO 2004/021867, titled “Endoscopic Accessory Mounting Adapter”, the disclosure of which is incorporated herein by reference, describes an adapter for releaseably securing tools to the distal end of an endoscope.

U.S. patent publication 2003/0036681 to Aviv et al., the disclosure of which is incorporated herein by reference, describes an optical transesophageal echocardiography probe which has an optical fiber running along its circumference.

SUMMARY OF THE INVENTION

An aspect of some embodiments of the present invention relates to a compact electrode carrier for mounting on an endoscope or other elongate invasive probe, such as a trans-esophageal ultrasound probe, without covering the distal end of the probe. The electrode carrier occupies a small portion of the axial extent of the endoscope or probe. Optionally, the electrode carrier occupies less than 25% or even less than 15% of the surface area of the portion of the probe suitable for insertion into the patient. In an exemplary embodiment of the invention, the electrode carrier has an area of less than 1500 square millimeters or even less than 800 square millimeters. In some cases, using a compact electrode carrier is simpler and cheaper than using a large electrode carrier sheath or sheet which covers most (or a large portion) of the endoscope. Optionally, the electrode carrier comprises a substrate (e.g., an isolating material) with one or more electrodes mounted thereon.

The electrode is optionally very thin (flat), so as not to substantially affect the cross-section area of the probe. Optionally, the attachment of the electrode increases the cross-section diameter of the probe by less than 2 millimeters, or even less than one millimeter. In an exemplary embodiment of the invention, the electrode increases the cross-section diameter of the probe by less than half a millimeter.

In some embodiments of the invention, the substrate and/or electrodes have layouts that are different over the circumference of the probe, such that, for example, even if the substrate and/or electrode need to be wide in one or more sectors of the circumference, they may be narrower or even none existent in other sectors of the circumference. Thus, the electrode carrier is made compact by having different substrate and/or electrode layouts cover different sectors of the circumference of the probe. Optionally, the entire length of a sector of the circumference of the probe is not covered by the substrate and/or by any of the one or more electrodes of the electrode carrier. In some embodiments of the invention, the sector of the probe not covered by the substrate and/or any electrodes includes at least a third, a half or even two thirds of the probe. When the electrode carrier is mounted on an ultrasound probe, the electrode carrier is optionally mounted onto the probe oriented such that the electrode or electrodes are directed in the same direction as an ultrasound sensor of the probe.

Optionally, in order to keep the electrode carrier to a small size, the electrode covers most of the area of the substrate. In some embodiments of the invention, the electrode covers more than 70%, 80% or even 90% of the surface area of the substrate.

In some embodiments of the invention, the substrate has different widths on different sectors of the circumference of the probe. Optionally, the substrate is wide in a sector on which the electrode is placed and is narrow on the remaining sectors of the circumference where the substrate serves as a strap for holding the electrode in place.

In some embodiments of the invention, the electrode carrier occupies less than 10% or even 5% of the length of the endoscope. Optionally, in these embodiments, the electrode carrier has an area of less than 400 or even less than 200 square millimeters. In an exemplary embodiment of the invention, the electrode carrier has an area of less than 100 square millimeters.

Alternatively or additionally, the electrode carrier occupies less than 30% or even less than 15% of the circumference of the probe over most, i.e., at least 50% or even 80%, of the length of the probe, over which the electrode carrier is placed. In accordance with this alternative, the electrode carrier is optionally attached to the probe using an adhesive and/or one or more attachment straps.

The electrode carrier may include a plurality of electrodes or, for compactness (e.g., when only a single electrode is required), may include only a single electrode.

In some embodiments of the invention, the electrode carrier includes a substrate which surrounds the entire circumference of the probe. Alternatively, the electrode carrier covers only a portion of the circumference of the probe. In some embodiments of the invention, the electrode carrier includes an adhesive which is used to connect the electrode carrier to the probe or endoscope. Optionally, the electrode carrier is removably attached to the endoscope or probe, so that it is easily removed after completion of a medical procedure in which the one or more electrodes on the electrode carrier are used. The adhesive is optionally a temporary adhesive which allows complete removal of the electrode, without damaging the probe and/or without leaving remnants on the probe.

In some embodiments of the invention, the electrode carrier includes a protective layer, which separates the probe from the electrode (or electrodes), in order to prevent damage to the probe from the electrical currents and/or heat in the electrode.

One or more functional units other than an electrode, such as an optical fiber or a pH sensor, may be integrated with, or introduced through, the electrode carrier.

An aspect of some embodiments of the present invention relates to a compact electrode carrier with an adhesive substrate for mounting on an endoscope or other elongate invasive probe. Using an adhesive for attachment of the electrode carrier to the probe, instead of mechanical attachment makes the attachment of the electrode carrier simpler and usable with a large range of probes.

An aspect of some embodiments of the present invention relates to a single-electrode carrier for mounting on an endoscope or other elongate invasive probe. The use of a single electrode, rather than a plurality of electrodes, may simplify the electrode carrier.

An aspect of some embodiments of the present invention relates to a compact electrode carrier for mounting on an elongate invasive probe. One or more flat electrodes are carried by the compact electrode carrier. The flat electrodes are optionally thinner than 2.5 millimeters, preferably thinner than 1 millimeter, over substantially the entire area of contact between the electrodes and the electrode carrier and/or of the intended contact area between the electrode and human tissue.

In some embodiments of the invention, the flat electrode is a straight electrode included in a single plane. Alternatively, the flat electrode has any other surface area shape, for example a wavy shape, optionally in order to conform to the shape of a probe on which it is mounted.

There is therefore provided in accordance with an exemplary embodiment of the invention, a method of adding at least one electrode to an invasive probe, comprising providing an invasive probe having a surface area, providing an electrode carrier including a substrate adapted for attaching to the probe, the substrate having an area smaller than 25% of the surface area of the probe and at least one electrode mounted on the substrate; and attaching the substrate to the probe, such that the layout of the substrate or of one or more of the at least one electrodes is substantially different in different sectors of the circumference of the probe.

Optionally, the substrate has a width shorter than 3 cm or even less than 1 cm, measured in an axial dimension of the invasive probe. Optionally, the substrate has a length measured along a circumference of the probe, sufficient to surround the circumference of the probe. Optionally, the substrate includes an adhesive on a surface opposite a surface of the substrate on which the electrode is mounted. Optionally, the substrate includes a protective electrical or heat isolating layer, which is located between the electrode and the probe.

Optionally, the protective isolating layer has a thickness of at least 0.1 mm. Optionally, the substrate is electrically conductive, serving as a part of the electrode. Optionally, the substrate is electrically isolative. Optionally, the electrode carrier includes at least one sensor additional to the electrode. Optionally, the probe comprises a protective sheath that covers the probe and wherein attaching the substrate to the probe comprises attaching the substrate to the protective sheath. Optionally, attaching the substrate to the probe comprises attaching without covering a distal 5 mm portion of the probe. Optionally, the at least one electrode comprises only a single electrode. Optionally, attaching the substrate to the probe comprises attaching such that over most of the length of the substrate, the substrate covers less than 20% of the circumference of the probe. Optionally, the electrode comprises a flat electrode and attaching the electrode to the probe comprises attaching along the length of the probe so as to increase the cross-section diameter of the probe by less than 2 millimeters.

Optionally, attaching the substrate to the probe comprises attaching such that the electrode conforms to the shape of the probe. Optionally, the electrode carrier is flexible. Optionally, the electrode carrier is more flexible than the invasive probe. Optionally, the electrode carrier includes a wire electrically coupled to the electrode and extending to a proximal end of the probe. Optionally, the method includes fastening the wire to the probe using a ring at a proximal side of the probe.

Optionally, the ring includes an electrical connector connecting the wire to an external electrical wire. Optionally, the electrode carrier includes a circuit for wirelessly receiving power. Optionally, providing the invasive probe comprises providing a probe previously used on one or more patients. Optionally, the method includes inserting the probe to the patient within an hour after attaching the substrate to the probe.

Optionally, attaching the substrate to the probe is performed within a medical treatment clinic. Optionally, providing the invasive probe comprises providing a probe whose production was completed. Optionally, providing the electrode carrier comprises providing the electrode carrier in a sterilized package. Optionally, the substrate has an area smaller than 10% of the surface area of the probe that is suitable for insertion into the patient. Optionally, attaching the substrate to the probe is performed such that the entire length of a sector of the circumference of the probe is not covered by the at least one electrode. Optionally, attaching the substrate to the probe is performed such that the entire length of at least half of the circumference of the probe is not covered by the at least one electrode.

Optionally, attaching the substrate to the probe comprises attaching such that the electrode is placed on less than 30% the circumference of the probe. Optionally, attaching the substrate to the probe is performed such that the entire length of a sector of the circumference of the probe is not covered by the substrate. Optionally, attaching the substrate to the probe is performed such that the substrate covers substantially different widths along the length of the probe in different sectors of the circumference of the probe.

Optionally, the substrate has an area smaller than 15 or even smaller than 5 square centimeters. Optionally, the at least one electrode covers more than 50% or even 75% of the substrate. Optionally, attaching the substrate to the probe comprises wrapping the substrate around at least a portion of the circumference of the probe. Optionally, attaching the substrate to the probe comprises attaching such that the substrate does not extend beyond the distal end of the probe. Optionally, attaching the substrate to the probe comprises attaching such that the substrate does not cover the distal end of the probe.

There is further provided in accordance with an exemplary embodiment of the invention, a method of adding an electrode to an invasive probe, comprising providing an invasive probe having a surface area, providing an electrode carrier including a substrate for attaching to the probe, the substrate having an area smaller than 25% of the surface area of the probe and a single electrode mounted on the substrate and attaching the substrate to the probe.

Optionally, the method includes an adhesive mounted on the substrate. Optionally, the adhesive is mounted on an opposite side of the substrate from the electrode. Optionally, the substrate has a width shorter than 3 cm, measured in an axial dimension of the invasive probe.

Optionally, the substrate has a length measured along a circumference of the probe, sufficient to surround the circumference of the probe. Optionally, the substrate includes a protective electrical or heat isolating layer, which is located between the electrode and the probe. Optionally, the electrode carrier includes at least one sensor additional to the electrode. Optionally, the electrode carrier includes a wire electrically coupled to the electrode and extending to a proximal end of the probe.

Optionally, the adhesive is such that pulling the electrode carrier off the probe removes the adhesive, such that substantially no adhesive remnants remain on the probe.

Optionally, the substrate has an area smaller than 1500 square millimeters.

There is further provided in accordance with an exemplary embodiment of the invention, a method of adding at least one electrode to an invasive probe, comprising providing an invasive probe having a surface area, providing an electrode carrier including a substrate for attaching to the probe, the substrate having an area smaller than 20% of the surface area of the probe and at least one electrode mounted on the substrate and attaching the substrate to the probe, such that the electrode does not extend beyond the surface of the probe by more than 2 mm.

Optionally, the electrode does not extend beyond the surface of the probe by more than 1 mm. Optionally, attaching the substrate to the probe comprises attaching without covering a distal 5 mm portion of the probe. Optionally, the at least one electrode comprises only a single electrode. Optionally, attaching the substrate to the probe comprises attaching such that over most of the length of the substrate, the substrate covers less than 30% of the circumference of the probe.

There is further provided in accordance with an exemplary embodiment of the invention, a method of adding at least one electrode to an invasive probe, comprising providing an invasive probe having a surface area, providing an electrode carrier including a substrate for attaching to the probe, the substrate having an area smaller than 25% of the surface area of the probe and at least one electrode mounted on the substrate, covering most of the surface area of the substrate and attaching the substrate to the probe.

Optionally, attaching the substrate to the probe comprises attaching without covering a distal 5 mm portion of the probe.

There is further provided in accordance with an exemplary embodiment of the invention, an electrode carrier kit for attachment of an electrode to an invasive probe having a given length and a given diameter, comprising an electrode carrier including a substrate having a surface area of less than 1500 square millimeters, adapted to be placed on an invasive probe, at least one electrode mounted on the substrate and an adhesive on the substrate and a package encompassing the electrode carrier.

Optionally, the at least one electrode has an area smaller than 75 square millimeters or even smaller than 40 square millimeters. Optionally, the substrate is adapted to be placed on the invasive probe in a specific orientation. Optionally, the electrode carrier includes a wire electrically coupled to the electrode and extending over at least 10 centimeters. Optionally, the wire extends over a sufficient length to connect to a proximal end of the probe, if the substrate is attached close to a distal end of the probe.

Optionally, the substrate has a surface area of less than 500 square millimeters or even less than 200 square millimeters. Optionally, the substrate has a ring shape and/or is elastic.

Optionally, the substrate comprises a “C” shape clip, adapted to be placed on the invasive probe. Optionally, the substrate has a length with mating fastening units at opposite ends. Optionally, the mating fastening units comprise wire ties.

Optionally, the mating fastening units comprise an adhesive surface and a surface adapted to attach to the adhesive surface. Optionally, the substrate is adapted to be placed on the probe with a width along the length of the probe shorter than the length along the circumference. Optionally, the substrate is adapted to be placed on the probe with a width along the length of the probe shorter than 4 centimeters.

Optionally, the substrate is adapted to be placed on the probe in a specific orientation by having a length of at least 30 millimeters.

Optionally, the substrate is adapted to be placed on the probe in an orientation in which over most of the length of the probe the substrate covers less than 20% of the circumference of the probe.

Optionally, the substrate is adapted to be placed on the probe in an orientation in which over most of the length of the probe the substrate covers less than 0.5 centimeters of the circumference of the probe. Optionally, the electrode carrier includes a single electrode. Optionally, the substrate is conductive and serves as part of the electrode. Optionally, the kit includes at least one C-clip or even two C-clips for attaching a wire attached associated with the electrode to the probe. Optionally, the package comprises a sterile package.

There is further provided in accordance with an exemplary embodiment of the invention, an invasive probe assembly, comprising an invasive probe having a surface area, and a tool carrier removably mounted on the invasive probe, including a substrate having an area smaller than 25% of the surface area of the probe and at least one tool mounted on the substrate, the layout of the substrate or of one or more of the at least one tool is substantially different in different sectors of the circumference of the probe.

Optionally, the substrate has a width shorter than 3 cm or even shorter than 1 cm, measured in an axial dimension of the invasive probe. Optionally, the substrate substantially entirely surrounds the circumference of the probe. Optionally, the substrate is attached to the probe by an adhesive. Optionally, the substrate includes a protective electrical or heat isolating layer, which is located between the tool and the probe. Optionally, the at least one tool comprises an electrode. Optionally, the substrate is electrically conductive, serving as a part of the electrode.

Optionally, the at least one tool comprises only a single electrode. Optionally, the substrate is electrically isolative. Optionally, the at least one tool comprises at least one sensor and at least one electrode. Optionally, the assembly includes a protective sheath that covers the probe and wherein the substrate is mounted on the protective sheath. Optionally, the substrate does not cover a distal 5 mm portion of the probe.

Optionally, over most of the length of the substrate, the substrate covers less than 20% of the circumference of the probe. Optionally, the tool comprises a flat electrode and wherein attaching the electrode to the probe increases the cross-section diameter of the probe by less than 2 millimeters. Optionally, the tool comprises an electrode which conforms to the shape of the probe. Optionally, the tool carrier is flexible. Optionally, the tool carrier is more flexible than the invasive probe. Optionally, the tool carrier includes a wire electrically coupled to the tool and extending to a proximal end of the probe. In some embodiments of the invention, the tool comprises a camera. Optionally, the wire is fastened to the probe using a ring at a proximal side of the probe.

Optionally, the ring includes an electrical connector connecting the wire to an external electrical wire. Optionally, the tool carrier includes a circuit for wirelessly receiving power.

Optionally, the probe is adapted for use in a plurality of patients. Optionally, the substrate has an area smaller than 10% of the surface area of the probe that is suitable for insertion into the patient. Optionally, the entire length of a sector of the circumference of the probe is not covered by the at least one tool. Optionally, the entire length of at least half of the circumference of the probe is not covered by the at least one tool. Optionally, the tool covers less than 30% the circumference of the probe. Optionally, the entire length of a sector of the circumference of the probe is not covered by the substrate. Optionally, the substrate covers substantially different widths along the length of the probe in different sectors of the circumference of the probe. Optionally, the substrate has an area smaller than 15 square centimeters or even less than 5 square centimeters. Optionally, the at least one tool covers more than 50% or even 75% of the substrate. Optionally, the substrate does not extend beyond the distal end of the probe and/or does not cover the distal end of the probe.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary non-limiting embodiments of the invention will be described with reference to the following description of the embodiments, in conjunction with the figures. Identical structures, elements or parts which appear in more than one figure are preferably labeled with the same or similar number in all the figures in which they appear, and in which:

FIG. 1 is a schematic side view of an ultrasound probe with an electrode carrier band mounted thereon, in accordance with an exemplary embodiment of the present invention;

FIG. 2 is a schematic illustration of an electrode carrier band, in accordance with an exemplary embodiment of the invention;

FIG. 3 is a flowchart of acts performed by a physician in employing an electrode carrier, in accordance with an exemplary embodiment of the invention;

FIG. 4 is a schematic illustration of a probe with a proximal wire port, in accordance with an exemplary embodiment of the invention;

FIG. 5 is a schematic illustration of a combined electrode and optical fiber attachment, in accordance with an exemplary embodiment of the invention;

FIG. 6 is a schematic illustration of an electrode add-on strip on a probe, in accordance with an exemplary embodiment of the invention;

FIG. 7 is a schematic illustration of a wireless ablation electrode carrier, for attachment to invasive probes, in accordance with an exemplary embodiment of the invention; and

FIG. 8 is a schematic illustration of a wireless ablation electrode carrier, for attachment to invasive probes, in accordance with another exemplary embodiment of the invention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

FIG. 1 is a schematic side view of an ultrasound probe 100 with an electrode carrier band 130 mounted thereon, in accordance with an exemplary embodiment of the present invention. Probe 100 includes an echocardiography sensor 107 and an elongate insertion tube 105. Probe 100 is optionally used for transesophageal echocardiography. By adding electrode carrier band 130 with an electrode 132 thereon to probe 100, probe 100 can be used for transesophageal cardioversion or cardiac pacing during a same procedure as the echocardiography.

FIG. 2 is a schematic illustration of electrode carrier band 130, in accordance with an exemplary embodiment of the invention. Carrier band 130 includes an electrode 132 and a wire 134 (or a group of wires), which electrically connects the electrode to a power generator, sensor, controller or other apparatus, at a proximal end of probe 100. Electrode 132 is optionally mounted on a substrate 136, which serves to attach the electrode to probe 100. In some embodiments of the invention, substrate 136 is covered with an adhesive on a surface opposite electrode 132, which surface is attached to probe 100. Optionally, substrate 136 is provided with a peel off sheet (not shown), which covers the adhesive before attaching substrate 136 to probe 100. Before using probe 100, the peel off sheet is removed and substrate 136 is attached to probe 100.

In some embodiments of the invention, substrate 136 is removably attached to probe 100. The adhesive optionally has sufficient strength required to prevent substrate 136 from inadvertently falling off of probe 100, while passing through body lumens. On the other hand, the adhesive is optionally not too strong, allowing purposeful removal of substrate 136 from probe 100 by a physician, without requiring large forces and/or extensive cleaning of the probe after removal of the electrode.

In some embodiments of the invention, substrate 136 comprises one or more protective layers, which protect probe 100 and the equipment within it, from the electrical energy passed through electrode 132. The protective layers optionally include an electrically isolative material, such as silicone, polyvinylchloride, polyurethane or any other suitable isolative material. The protective layer optionally has a thickness of at least 0.1 mm or even 0.25 mm, in order to provide sufficient isolation. In some embodiments of the invention, the protective layer is thinner than 0.3 mm or even thinner than 0.15 mm, in order to limit the enlargement of the cross-section of the probe, when substrate 136 is attached to the probe. Alternatively, a substrate 136 is not included in carrier band 130 and electrode 132 is directly mounted on probe 100 (i.e., a portion of electrode 132 serves as the substrate).

The substrate together with the electrode are optionally sufficiently flexible to take the form of the probe surface on which they are mounted. In some embodiments of the invention, the substrate together with the electrode is more flexible than the probe 100, at least the area of the probe on which substrate 136 is mounted.

Electrode 132 optionally comprises a bio-compatible metal, such as titanium, silver, stainless steel or gold. Alternatively, the electrode comprises an alloy of metals, optionally including one or more of the above materials. In some embodiments of the invention, electrode 132 includes a highly conductive outer film. The conductive film is optionally used to cover a material base with a lower electrical conductance.

In some embodiments of the invention, electrode 132 is used for sensing electrical signals from the patient. Alternatively or additionally, electrode 132 is used for stimulating tissue. Further alternatively or additionally, electrode 132 is used for any other task requiring an electrode, for example serving as a ground electrode. Electrode 132 may be used for substantially any type of ablation known in the art, including heat ablation, current ablation and RF ablation.

Size

Substrate 136 optionally has a width (w) of between about 5-20 mm, e.g., 10-13 mm, for placing along the length of probe 100. Thus, less than 10% or even 5% of the length of probe 100 is covered by electrode carrier band 130. In some embodiments of the invention, less than 1% of probe 100 is covered by electrode carrier band 130.

In some embodiments of the invention, the length (l) of substrate 136 is sufficient to surround the entire circumference of probe 100. For example, for a probe of a diameter of 2.5 centimeters, substrate 136 optionally has a length (l) of between about 7.8-8.5 centimeters. At its ends, substrate 136 optionally has mating fastening elements and/or an adhesive strip, as described below. In some embodiments of the invention, substrate 136 is elastic so that it can be stretched along its length (l), for example if necessary to surround probe 100.

Alternatively to substrate 136 being larger than electrode 132, substrate 136 is substantially the size of a required electrode, in order to limit the addition to the circumference size of probe 100 from mounting electrode 132 on the probe. As shown, electrode 132 is much smaller than substrate 136. In other embodiments of the invention, electrode 132 covers most (optionally more than 75%), or even substantially all, of substrate 136. In an exemplary embodiment of the invention, electrode 132 has a largest dimension smaller than 1.5 centimeters or even smaller than 1 centimeter. Optionally, electrode 132 has an area smaller than 80 square millimeters, 60 square millimeters or even smaller than 40 square millimeters.

Further alternatively, electrode 132 is larger than substrate 136, such that while some areas of electrode 132 are separated from probe 100 by substrate 136, while other areas of electrode 132 are in direct contact with the probe and/or areas of electrode 132 are above areas of probe 100, without substrate 136 separating between electrode 132 and the probe.

Electrode 132 optionally has a thickness as measured from its contact points with substrate 136, of less than 1 millimeter or even less than 0.5 millimeters. In an exemplary embodiment of the invention, the thickness of electrode 132 is less than 0.25 millimeters.

In some embodiments of the invention, substrate 136 and electrode 132 together are very thin, such that the transition from an area of the probe without substrate 136 to an area of the probe with substrate 136 is smooth. Optionally, the edges of substrate 136 are tapered so that there is virtually no step between the substrate and its surroundings. Alternatively, substrate 136 and electrode 132 are together relatively thick, such that a finger passed over the probe will feel the transition to the area including substrate 136.

Other Attachment Methods

Alternatively or additionally to an adhesive on the surface of substrate 136 opposite electrode 132, substrate 136 has an adhesive strip 138 at its end 142. When substrate 136 is wrapped around probe 100, adhesive strip 138 attaches to an opposite end 140 of the substrate, thus forming a ring around probe 100. This may be advantageous to avoid applying adhesive directly to the probe, which could pose cleaning problems.

In some embodiments of the invention, the surface opposite electrode 132, which is attached to probe 100, uses friction to prevent slipping of electrode carrier band 130 along the probe or from totally falling off. In some embodiments of the invention, carrier band 130 is stretched on probe 100 in a manner which enhances the friction. Carrier band 130 is optionally elastic in a manner which allows the stretching. In some embodiments of the invention, substrate 136 is connected to electrode 132 at a limited number of points in a manner which allows stretching of the substrate without applying strong forces to the electrode. Alternatively or additionally, the surface opposite electrode 132 is roughened to enhance the friction.

In other embodiments of the invention, ends 140 and 142 of substrate 136 include matching mechanical connectors. Optionally, the connectors allow fastening around probes of different circumference sizes. In some embodiments of the invention, the mechanical connectors include wire ties, although any other mechanical connectors may be used.

Alternatively, the connectors are set for a predetermined probe circumference size. For example, the connectors may include one or more snaps.

Further alternatively or additionally, substrate 136 comprises a “C-shaped” clip that snaps on to the circumference of probe 100. Alternatively or additionally, one or more rings formed of a heat shrinking material are used. The rings or first loaded onto the probe 100 and are then heated to shrink and firmly hold electrode carrier 130 in place. In other embodiments of the invention, substrate 136 comprises a complete ring that is slid on to probe 100. In these embodiments, substrate 136 optionally comprises an elastic band, which is stretched by a physician in order to slide it onto probe 100. When the band is at a desired position along the length of probe 100, the band is released by the physician so that it snugly contracts onto probe 100. Optionally, the band is slid onto probe 100 from the distal end of the probe, down to a desired position distanced from the distal end of the probe. Alternatively, for example with probes redesigned to have small handles or with probes having detachable handles, the band is slid onto probe 100 from its proximal end.

Placement

Electrode 132 may optionally be mounted at substantially any required location along probe 100. In some embodiments of the invention, electrode 132 is distanced from echocardiography sensor 107 (FIG. 1) by at least 4-6 mm, in order to prevent interference to sensor 107 from electrode 132. Substrate 136 optionally does not extend beyond the distal end of the probe and/or does not cover the distal end of the probe, in order not to interfere with the insertion of the probe into the patient and/or so that the electrode is not harmed, due to its insertion without firm backing of the probe.

In some embodiments of the invention, electrode 132 may be mounted on a sheath that covers probe 100, after the sheath already covers the probe. For example, probe 100 may be covered by a protective sheath that isolates the probe from body fluids and prevents contamination of the probe. The attachment means used to connect electrode 132 to probe 100 are optionally suitable for connecting to the sheath and/or for connecting to the probe while the sheath covers the probe. For example, when adhesive strip 138 is used, the adhesive is optionally suitable for bonding to the sheath materials. It is noted that when electrode 132 is mounted on a disposable sheath, there is no need to clean adhesive remnants off the sheath, after removal of the electrode. Optionally, the protective layers of substrate 136, if used, are devised according to the material of the sheath with which electrode 132 is planned to be used.

In some embodiments of the invention, a sheath is preplanned for use with electrode carrier band 130. Optionally, the sheath has a marking indicating a location at which the electrode 132 is to be mounted. Alternatively or additionally, the sheath has a slot adapted to receive substrate 136. The slot is optionally formed by two folds in the sheath that are spaced from each other by the width of substrate 136. In other embodiments of the invention, the sheath includes two pockets that receive the ends 140 and 142 of the substrate. Alternatively or additionally, the sheath is adapted for receiving wire 134, for example in accordance with any of the wire placements described below.

Producing a sheath that is only adapted for receiving an electrode, rather than including the electrode, is useful in cases when the sheath is meant for use both with and without an electrode. A sheath prepared for mounting an electrode is generally cheaper and/or better fit for use than a sheath that has an electrode, which electrode may not be used in many medical procedures.

Preparation of Probe for Use

FIG. 3 is a flowchart of acts performed by a physician in employing electrode 132, in accordance with an exemplary embodiment of the invention. Optionally, electrode 132 is provided in a kit or assembly having the electrode in a package, optionally a sterile package. The physician optionally removes (302) the electrode from its package. The electrode is optionally placed (304) on the probe in a desired position and orientation, as discussed above with relation to FIG. 2. The electrode is attached (306) to the probe using any of the attachment methods described above and/or any other suitable attachment method. For example, the physician may remove a peel off sheet from substrate 136 and connect an adhesive on the substrate to the probe.

Wire 134 is then optionally fixed (308) along the probe, so that it does not interfere with the insertion of the probe into the patient. In some embodiments of the invention, a proximal collar is mounted (310) on a proximal end of probe 100, so as to hold wire 134 in place. An exemplary embodiment of a collar is described below with reference to FIG. 4. The proximal end of wire 134 is connected (312) to a generator or other control apparatus.

Wire Placement

Referring in more detail to fixing (308) wire 134 along the probe, in some embodiments of the invention, the wire is wrapped around the probe in a helical manner, as shown in FIG. 1. Optionally, wire 134 is wrapped around the probe at most 5 rounds, so as not to require a long wire segment for the wrapping. Alternatively, wire 134 is wrapped around the probe more than 5, 10 or even 20 rounds, so as to keep the wire in place. Wire 134 optionally has a length corresponding to a recommended number of wire wrapping turns around the length of the probe. In some embodiments of the invention, the wire has a length of at least 5, 10 or even 20 centimeters, beyond the length of the probe. Optionally, the wire has a length of at least 120 centimeters.

In some embodiments of the invention, after mounting electrode carrier band 130 on probe 100, the probe is covered by a sheath. The sheath optionally has a window above electrode 132 and/or extends from the proximal end of probe 100 only up to (not including) the location of electrode carrier band 130. The sheath optionally serves to hold wire 134 in place. Alternatively or additionally, bands, C-shaped clips and/or hooks may be used to keep wire 134 adjacent to probe 100.

FIG. 4 is a schematic illustration of probe 100 with a proximal wire port 160, in accordance with an exemplary embodiment of the invention. Port 160 is optionally mounted on probe 100 close to the proximal end of the probe, for example, within the proximal 10% or even the proximal 5% of the probe. Port 160 includes a collar 162 with a locking ring 164 which is used to fasten collar 162 to the probe. A socket 166, electrically coupled to wire 134, is mounted on collar 162. The socket is adapted to receive a corresponding plug 170 of an electrical cable that leads, for example, to a power generator.

Port 160 optionally provides a stronger attachment than the connection of wire 134 to probe 100. The strong connection prevents inadvertent pulling of the wires out of place.

Locking ring 164 optionally includes a latch, so that collar 162 can be used with substantially any probe size. Alternatively or additionally, any other attachment mechanism may be used, for example any of those described above with relation to electrode substrate 136.

In some embodiments of the invention, electrode carrier band 130 includes at least one additional functional sensor or tool, which adds to the functionality of probe 100. Such an additional sensor may include, for example, one or more of an acidity (pH) sensor, a position sensor, an active beacon, illumination LEDs and/or an optical fiber. In some embodiments of the invention, carrier band 130 includes a miniature camera (e.g., CCD, CMOS), which is used to acquire images within body cavities. Carrier band 130 optionally includes a thin lens (e.g., having a 1 millimeter thickness), which covers the miniature camera and focuses light onto the camera.

Additional wires parallel to wire 134 of electrode 132 may be used for sensors or tools requiring access wires. The additional wires may be packaged together with wire 134, for example the wires may be woven together or they may be bundled in a single unit. Alternatively, the wires may be packaged separately.

FIG. 5 is a schematic illustration of a combined electrode and optical fiber attachment 200, in accordance with an exemplary embodiment of the invention. Attachment 200 is similar to electrode carrier band 130 but additionally includes an optical fiber 202 (or bundle of fibers), which is used to illuminate and/or view the vicinity in front of a probe on which attachment 200 is mounted, while the probe is inserted into a patient. The distal end 204 of optical fiber 202 optionally extends a predetermined distance beyond substrate 136, such that when the distal end 204 of fiber 202 is suitably positioned for viewing, electrode 132 is at an optimal position for ablation and/or for any other task for which it is utilized. Alternatively, fiber 202 is movable axially relative to substrate 136, so as to accommodate different probes 100. In some embodiments of the invention, fiber 202 is only allowed to move along a limited extent for which adjustment is expected to be required, for example of less than 12 mm or even less than 8 mm. Optionally, fiber 202 has two notches 206, separated by the maximal movement extent allowed, which limit axial movement of the fiber. Alternatively, any other method of limiting the movement extent is used. In some embodiments of the invention, fiber 202 is allowed to move only in a single direction relative to substrate 136, for example, fiber 202 may only be allowed to retract. Fiber 202 and/or substrate 132 optionally include markings that are to be aligned for specific types of probes, thus aiding the physician in setting the relative orientation of the fiber and substrate. The markings may be visible markings and/or indents which can be felt by the user.

As shown, fiber 202 is distanced from wire 134. This embodiment may be used, for example, when it is desired to wrap wire 134 around the probe, while laying fiber 202 substantially straight on the probe or when it is otherwise desired that fiber 202 and wire 134 run along separate paths. In other embodiments of the invention, wire 134 runs along fiber 202, making attachment 200 more compact.

FIG. 6 is a schematic illustration of an electrode add-on strip 350 on a probe 100, in accordance with an exemplary embodiment of the invention. Unlike the above described embodiments, strip 350 may extend over a large percentage of the length of probe 100. Strip 350, however, only covers a small percentage, for example less than 20% or even less than 10%, of the circumference of probe 100. Strip 350 is optionally attached to probe 100 (or to a sheath covering the probe) using an adhesive. The adhesive may be spread substantially over the entire length and/or area of strip 350 or may be concentrated at several (e.g., 3-10) points along the length of the substrate. Alternatively or additionally, strip 350 includes one or more lateral bands 352 that fit around probe 100 and hold strip 350 against the probe. As shown, strip 350 includes three electrodes 354. It is noted, however, that strip 350 can include more electrodes or fewer electrodes. In an exemplary embodiment of the invention, strip 350 mounts only a single electrode 354.

In some embodiments of the invention, strip 350 is placed on probe 100 along most of its length, from its proximal end to the location of the most distal electrode. Optionally, wires connecting probe 100 to an external unit are mounted on strip 350 and/or are embedded within strip 350.

FIG. 7 is a schematic illustration of a wireless ablation electrode carrier 700, for attachment to invasive probes, in accordance with an exemplary embodiment of the invention. Electrode carrier 700 optionally carries a coil for receiving electrical energy through magnetic coupling. The current received by coil 702 passes through a resistor 704 which converts the electrical current into heat. The heat is passed to a heat transfer electrode 706 that contacts tissue and performs the ablation. Alternatively to a resistor, electrode carrier 700 may include an RF antenna that generates RF waves for ablation, from the electrical power received by coil 702. Electrode carrier 700 is optionally relatively thin, of the order of 0.1-0.7 millimeters. Suitable production methods of miniature electrical elements for electrode carrier 700 are well known, for example in the field of smart cards.

FIG. 8 is a schematic illustration of a wireless ablation element carrier 750, for attachment to invasive probes, in accordance with an exemplary embodiment of the invention. Carrier 750 includes a flat surface ablation element 752, which is sufficiently large and has a suitable resistance to allow inducing of eddy currents therein. The eddy currents in ablation element 752 optionally heat body tissue for ablation.

Carriers 700 and 750 may be attached to probe 100 using any of the methods described above relating to carrier band 130.

Alternatively or additionally, wireless transfer of power to an element mounted on the probe may be performed using any other wireless power transfer method, including, for example, using a piezo-electric power receiver.

The present invention is not limited to attachment carriers carrying electrodes. Rather, attachment carriers for attachment to invasive probes may carry other tools, such as an ablation unit, a camera, sensors (e.g., acidity sensor) and/or LEDs.

It will be appreciated that the above-described apparatus and methods may be varied in many ways, including, changing the order of steps of the employing of the electrode, and/or performing a plurality of steps concurrently. It should also be appreciated that the above described description of methods and apparatus are to be interpreted as including apparatus for carrying out the methods, and methods of using the apparatus.

The present invention has been described using non-limiting detailed descriptions of embodiments thereof that are provided by way of example and are not intended to limit the scope of the invention. It should be understood that features and/or steps described with respect to one embodiment may be used with other embodiments and that not all embodiments of the invention have all of the features and/or steps shown in a particular figure or described with respect to one of the embodiments. For example, carrier band 130 and/or attachment 200 may be used with an invasive tool with two sheaths. An inner sheath may be used for example to prevent contamination, while an outer sheath is used to hold wire 134 and/or fiber 202 in place. Variations of embodiments described will occur to persons of the art. Furthermore, the terms “comprise,” “include,” “have” and their conjugates, shall mean, when used in the claims, “including but not necessarily limited to.”

It is noted that some of the above described embodiments may describe the best mode contemplated by the inventors and therefore may include structure, acts or details of structures and acts that may not be essential to the invention and which are described as examples. Structure and acts described herein are replaceable by equivalents which perform the same function, even if the structure or acts are different, as known in the art. Therefore, the scope of the invention is limited only by the elements and limitations as used in the claims.