# Patent

## Title
Tools for use in esophagus

## Abstract

Apparatus (10) is provided, including an elongate carrier (24), configured to be advanced through an esophagus (20) of a subject. An anchor member (30) is coupled to a distal end of the carrier, and configured to be mounted in a stomach (32) of the subject in a vicinity of a lower esophageal sphincter (LES) (34) of the subject. An imaging capsule (26) is configured to move with respect to the carrier when the anchor member is in the vicinity of the LES. Other embodiments are also described.

## Background
CROSS-REFERENCES TO RELATED APPLICATIONS
The present application is the U.S. national phase application of PCT Application no. PCT/IL2006/000890 to Goldwasser et al., filed Aug. 1, 2006, which claims the benefit of U.S. Provisional Patent Application 60/704,656 to Goldwasser et al., filed Aug. 1, 2005, which is assigned to the assignee of the present patent application and is incorporated herein by reference. The International Application was published in English on Feb. 8, 2007 as WO 2007/015241 A2 under PCT Article 21(2).


FIELD OF THE INVENTION
The present invention relates generally to a pressure-propelled system, suitable for imaging body lumens, such as the esophagus.
BACKGROUND OF THE INVENTION
Many imaging devices are known for producing medical images of body lumens, such as the gastrointestinal (GI) tract. For example, endoscopy is widely used for observing, photographing tissue, and taking specimens from lesions and the like.
US Patent Application Publication 2005/0154355 to Gross et al., which is assigned to the assignee of the present application and is incorporated herein by reference, describes apparatus for use with a fluid pressure source. The apparatus includes an elongate carrier, adapted to be inserted through a proximal opening of a body lumen, and a distal piston head coupled to a distal portion of the carrier. The piston head is adapted to be in direct contact with a wall of the lumen when the carrier is inserted into the lumen, and to be advanced distally through the body lumen in response to pressure from the fluid pressure source.
The following references, which are incorporated herein by reference, may be of interest:
US Patent Application Publication 2004/0102681 to Gross
US Patent Application Publication 2005/0036059 to Goldwasser
US Patent Application Publications 2005/0038318 and 2005/0038319 to Goldwasser
US Patent Application Publication 2005/0038335 to Gross et al.
US Patent Application Publication 2005/0154278 to Cabiri et al.
PCT Publication WO 05/065044 to Cabiri et al.
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SUMMARY OF THE INVENTION
In some embodiments of the present invention, an imaging system is provided for examining an esophagus of a subject. The system comprises an elongate carrier coupled at a distal end thereof to an inflatable anchoring member. The anchoring member is inserted via the esophagus to a site in the stomach in a vicinity of a lower esophageal sphincter (LES), and inflated so as to anchor the distal end of the carrier. The system further comprises an imaging capsule configured to travel along the carrier distally and proximally in the esophagus (i.e., towards the stomach and towards the mouth, respectively). The imaging capsule comprises at least one imaging element, which is configured to image the esophagus.
In some embodiments of the present invention, the imaging capsule comprises a piston head, which is configured to form a pressure seal with a wall of the esophagus. Pressure from a fluid pressure source is applied to the area of the esophagus between the piston head and the anchoring member. The pressure causes the imaging capsule to travel proximally through the esophagus. Alternatively, the imaging capsule is withdrawn proximally using a wire.
There is therefore provided, in accordance with an embodiment of the invention, apparatus, including:
an elongate carrier, configured to be advanced through an esophagus of a subject;
an anchor member, coupled to a distal end of the carrier, and configured to be mounted in a stomach of the subject in a vicinity of a lower esophageal sphincter (LES) of the subject; and
an imaging capsule, configured to move with respect to the carrier when the anchor member is in the vicinity of the LES.
In an embodiment, the capsule includes a sample collection unit, configured to sample fluid or tissue of the esophagus.
In an embodiment, the apparatus includes a sample collection unit coupled to the carrier and not an integral portion of the imaging capsule, wherein the collection unit is configured to sample fluid or tissue of the esophagus.
In an embodiment, the imaging capsule is shaped to define a bore thereof, and wherein the carrier is configured to pass through the bore to allow the imaging capsule to move with respect to the carrier.
In an embodiment, the anchor member includes an inflatable anchor member.
In an embodiment, the anchor member includes a non-inflatable anchor member, shown as one example 30n in FIG. 2.
There is further provided, in accordance with an embodiment of the invention, apparatus for use with a biologically-compatible-fluid pressure source, including:
an elongate carrier, configured to be advanced through an esophagus of a subject;
an inflatable anchor member, coupled to a distal end of the carrier, and configured to be mounted in a stomach of the subject in a vicinity of a lower esophageal sphincter (LES) of the subject, and to form a pressure seal upon inflation; and
an imaging capsule, configured to travel along the carrier, the imaging capsule including:
an imaging element; and
a piston head configured to:

    
    
        form a pressure seal with a wall of the esophagus, and
        be advanced proximally through the esophagus in response to pressure from the fluid pressure source.
    
    


In an embodiment, the capsule includes a sample collection unit, configured to sample fluid or tissue of the esophagus.
In an embodiment, the apparatus includes a sample collection unit coupled to the carrier and not an integral portion of the imaging capsule, wherein the collection unit is configured to sample fluid or tissue of the esophagus.
There is still further provided, in accordance with an embodiment of the invention, a method, including:
advancing an elongate carrier through an esophagus of a subject;
mounting in a stomach of the subject in a vicinity of a lower esophageal sphincter (LES) of the subject an anchor member that is coupled to a distal end of the carrier; and
moving a capsule with respect to the carrier when the anchor member is in the vicinity of the LES.
In an embodiment, moving the capsule includes moving an imaging capsule.
In an embodiment, moving the capsule includes moving a capsule that applies a treatment to the esophagus.
In an embodiment, the method includes sampling fluid or tissue of the esophagus by the capsule.
In an embodiment, the capsule is shaped to define a bore thereof, and including placing the carrier within the bore.
In an embodiment, mounting the anchor member includes inflating the anchor member when it is in the stomach.
In an embodiment, mounting the anchor member includes expanding the anchor member when it is in the stomach.
The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:



BRIEF DESCRIPTION OF THE DRAWINGS
FIGS. 1 and 2 are schematic illustrations of an imaging system configured to be inserted into an esophagus of a subject, in accordance with an embodiment of the present invention; and
FIG. 3 is a schematic illustration of the imaging system of FIG. 1, in accordance with another embodiment of the present invention.



DETAILED DESCRIPTION OF EMBODIMENTS
FIGS. 1 and 2 are schematic illustrations of an imaging system 10 configured to be inserted into an esophagus 20 of a subject, in accordance with an embodiment of the present invention. System 10 comprises an elongate carrier 24, an imaging capsule 26 configured to travel along the carrier, and an inflatable anchoring member 30 coupled to a distal end of carrier 24. Imaging capsule 26 comprises at least one imaging element 31, which is configured to image esophagus 20. Anchoring member 30 is inserted via esophagus 20 to a site in a stomach 32 in a vicinity of a lower esophageal sphincter (LES) 34, and inflated so as to anchor the distal end of carrier 24.
Imaging capsule 26 and anchoring member 30 are typically advanced distally through esophagus 20 by positioning the imaging capsule at a distal end of carrier 24 near the anchoring member, and pushing on carrier 24 until anchoring member 30 reaches stomach 32. Alternatively, carrier 24 and anchoring member 30 are first advanced through esophagus 20, and a tube 44 is used to push imaging capsule 26 over the inserted carrier. (Tube 44 may be larger than as shown in FIG. 1, and, for some applications, may surround carrier 24.)
In an embodiment of the present invention, elongate carrier 24 comprises a plurality of tubes and communication wires. An interior of anchoring member 30 is, in an embodiment, in fluid communication with a pressure source 42 via an anchoring member fluid supply tube 46. Pressure source 42 provides a pressurized biologically-compatible fluid, such as but not limited to, a source of pressurized air, CO2, or water, in order to inflate anchoring member 30.
In an embodiment of the present invention, imaging capsule 26 comprises an inflatable piston head 40. The piston head is configured to be inflated in response to pressure from fluid pressure source 42 delivered via a piston fluid supply tube 48. Once inflated, piston head 40 forms a pressure seal with a wall 50 of esophagus 20. Piston head 40 comprises a medically-safe elastomeric material, such as polyurethane or silicone rubber. Piston head 40 is configured to travel proximally (i.e., towards the mouth) through esophagus 20 in response to pressure from fluid pressure source 42 delivered, via an advancement fluid supply tube 52, to a volume of esophagus 20 between piston head 40 and anchoring member 30. Alternatively, imaging capsule 26 is withdrawn proximally using tube 44.
Imaging element 31 comprises a camera (e.g., CCD or CMOS), or an x-ray, ultrasonic, MRI, infrared, microwave imaging device, or another sensor configured to perform an optical biopsy of the esophagus. For some applications, imaging element 31 comprises one or more lenses configured to enable forward and omnidirectional viewing, and/or means for illuminating the esophagus. For example, techniques may be used that are described in U.S. Provisional Patent Application 60/571,438, filed May 14, 2004, and/or International Patent Application PCT/IL2005/000500, filed May 11, 2005, both of which are assigned to the assignee of the present application and are incorporated herein by reference. Alternatively or additionally, imaging element 31 is positioned to enable viewing in a proximal direction.
In an embodiment of the present invention, system 10 comprises one or more pulleys 54, which enable imaging capsule 26 to be pulled distally via wires 56. This embodiment may be practiced in addition to the use of a piston head, as described, or, alternatively, without the use of a piston head.
In an embodiment of the present invention, carrier comprises a plurality of markers 60 that enable an operator of system 10 to visually determine a depth of imaging capsule 26 in the esophagus from the patient's teeth. Alternatively or additionally, the operator may view the markers using imaging element 31.
Although piston head 40 has been described in embodiments of the present invention as being in direct contact with wall 50 of esophagus 20, the scope of the invention includes establishing contact between the piston head and the wall of the esophagus through an intermediary, such as a sheath surrounding the piston head.
FIG. 3 is a schematic illustration of imaging system in accordance with an embodiment of the present invention. In the embodiment shown in FIG. 3, piston head 40 (FIG. 2) is not utilized. Instead, imaging capsule 26 is attached to a tube 70 that typically surrounds carrier 24. Tube 70 is free to advance and withdraw capsule 26. Capsule 26, in turn, is free to move proximally or distally with respect to carrier 24. In this manner, carrier 24 serves as a monorail, which is inserted into the esophagus at the beginning of a procedure, and maintained in place by anchoring member 30.
While anchoring member 30 is inflatable in accordance with some embodiments of the present invention, for some applications other techniques known in the art for stabilizing a tool in the gastrointestinal tract are used in order to maintain the position of member 30 near the lower esophageal sphincter.
In an embodiment, system 10 comprises a sample collection unit 80, shown in FIG. 1 in capsule 26 and in FIG. 2 as not an integral portion of the capsule, which is configured to collect a tissue or fluid sample from the esophagus. For example, the collection unit may use suction to pull tissue into a collection compartment, whereupon the tissue is excised by a cutting instrument. The excised tissue is maintained within the collection unit, and, typically, a portion of the collection unit closes in order to maintain separation of the excised tissue from the surrounding environment. The closure of the collection unit and excision of the tissue may, for some applications, be accomplished by the cutting instrument, which is typically activated by an actuator under physician control. Alternatively, a suitably-instrumented mechanical arm extends from the collection unit and retrieves a sample for biopsy.
Upon completion of the procedure, the collection unit is typically withdrawn proximally. For some applications, the collection unit performs analysis (e.g., chemical or optical analysis) of collected samples in situ, such as using techniques known in the art, and, typically, transmits information to a site outside of the patient's body. For example, the information may include raw data or results of analysis, and may be transmitted over wires or wirelessly.
In an embodiment, system 10 applies a drug to a site of the esophagus, in response to or independently of data retrieved or samples collected by system 10.
The scope of the present invention includes embodiments described in the following applications, all of which are assigned to the assignee of the present application and are incorporated herein by reference. In an embodiment, techniques and apparatus described in one or more of the following applications are combined with techniques and apparatus described herein.
US Patent Application Publication 2005/0154355 to Gross et al.
US Patent Application Publication 2004/0102681 to Gross
US Patent Application Publication 2005/0036059 to Goldwasser
US Patent Application Publications 2005/0038318 and 2005/0038319 to Goldwasser
US Patent Application Publication 2005/0038335 to Gross et al.
US Patent Application Publication 2005/0154278 to Cabiri et al.
PCT Publication WO 05/065044 to Cabiri et al.
U.S. patent application Ser. No. 10/967,922 to Cabiri et al., filed Oct. 18, 2004, entitled, “Pressure-propelled system for body lumen”
U.S. patent application Ser. No. 10/523,578 to Gross et al., filed Jan. 28, 2005, entitled, “Self-propelled imaging system”
U.S. Provisional Patent Application 60/571,438 to Dotan et al., filed May 14, 2004, entitled, “Omnidirectional and forward-looking imaging device”
U.S. Provisional Patent Application 60/607,986 to Cabiri et al., filed Sep. 8, 2004, entitled, “Mechanical aspects of pressure-propelled system for body lumen”
U.S. Provisional Patent Application 60/642,245, filed Jan. 6, 2005, entitled, “Gastrointestinal tool over guidewire”
International Patent Application PCT/IL2005/000178 to Goldwasser et al., filed Feb. 10, 2005, entitled, “Gastrointestinal tool over guidewire”
U.S. Provisional Patent Application 60/652,049 to Goldwasser et al., filed Feb. 10, 2005, entitled “Advanced techniques for gastrointestinal tool with guiding element”
U.S. Provisional Patent Application 60/680,074 to Degtiar et al., filed May 11, 2005, entitled, “Disposable endoscope connector”
an international patent application to Dotan et al., filed May 11, 2005, entitled, “Omnidirectional and forward-looking imaging device”
U.S. patent application Ser. No. 10/753,424 to Gross et al., entitled, “Pressure-propelled system for body lumen,” filed Jan. 9, 2004
U.S. Provisional Patent Application 60/704,656 to Goldwasser et al., entitled, “Tools for use in esophagus,” filed Aug. 1, 2005
a PCT patent application to Degtiar et al., entitled, “Disposable endoscope connector,” filed May 11, 2006
a PCT patent application to Cabiri et al., entitled, “Endoscopic measurement techniques,” filed May 11, 2006
a PCT patent application to Goldwasser et al., entitled, “Tools for use in small intestine,” filed on even date herewith.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

## Claims

1. Apparatus for imaging the esophagus of a subject, comprising:
an anchor member comprising an inflatable anchor member so dimensioned as to have a lateral diameter less than the diameter of the lower esophageal sphincter (LES) of the subject when deflated and having a lateral diameter greater than the diameter of the LES of the subject when inflated, said anchor member being configured to pass through the LES of the subject into the subject's stomach and form a pressure seal with the LES upon inflation thereof;
an elongate carrier, configured to be advanced through the esophagus of the subject to the stomach of the subject, and comprising an anchor fluid supply tube, the distal end of which extends into the anchor member for supplying fluid pressure from a fluid pressure source to inflate the anchor member;
an imaging capsule, configured to move along the carrier when the anchor member is in the vicinity of the LES;
a piston head coupled to the imaging capsule configured to form a pressure seal with a wall of the esophagus upon inflation thereof to thereby allow moving the imaging capsule along the carrier in response to fluid pressure applied to a volume of the esophagus external to the apparatus between the piston head and the anchor member, said piston head being configured to travel proximally through the esophagus from the LES to the mouth of the subject in response to pressure from a fluid pressure source delivered to the volume of the esophagus between said piston head and said anchor member; and
a fluid supply tube for supplying fluid pressure to the volume of the esophagus between said piston head and said anchor member when in use.

2. The apparatus according to claim 1, wherein the imaging capsule comprises a sample collection unit, configured to retrieve a sample fluid or tissue of the esophagus by at least one of suction and a cutting instrument provided via an opening provided therein.

3. The apparatus according to claim 1, wherein the apparatus comprises a sample collection unit coupled to the carrier and not an integral portion of the imaging capsule, wherein the collection unit is configured to sample fluid or tissue of the esophagus.

4. The apparatus according to claim 1, wherein the imaging capsule is shaped to define a bore thereof, and wherein the carrier is configured to pass through the bore to allow the imaging capsule to move with respect to the carrier.

5. The apparatus according to claim 1, wherein
the imaging capsule is configured to travel along the carrier, and wherein the imaging capsule comprises:
an optical imaging element.

6. The apparatus according to claim 5, wherein the imaging capsule comprises a sample collection unit, configured to retrieve a sample fluid or tissue of the esophagus by at least one of suction and a cutting instrument provided via an opening provided therein.

7. The apparatus according to claim 5, wherein the apparatus comprises a sample collection unit coupled to the carrier and not an integral portion of the imaging capsule, wherein the collection unit is configured to sample fluid or tissue of the esophagus.

8. The apparatus according to claim 1, comprising at least one wire configured to move the imaging capsule with respect to the carrier when the anchor member is in the vicinity of the LES.

9. The apparatus according to claim 8, comprising one or more pulleys to facilitate movement of the imaging capsule along the carrier via the at least one wire.

10. The apparatus according to claim 1, comprising a tube for moving the imaging capsule with respect to the elongate carrier.

11. A method for imaging the esophagus of a subject using the apparatus of claim 1, comprising:
advancing said elongate carrier through an esophagus of a subject;
mounting in the stomach of the subject in the vicinity of the lower esophageal sphincter (LES) of the subject said anchor member that is coupled to the distal end of said carrier; and
moving said imaging capsule with respect to said carrier when said anchor member is in the vicinity of the LES.

12. The method according to claim 11, wherein said imaging capsule applies a treatment to the esophagus.

13. The method according to claim 11, wherein the imaging capsule comprises a sample collection unit, configured to retrieve a sample fluid or tissue of the esophagus by at least one of suction and a cutting instrument provided via an opening provided therein, and further comprising comprising sampling fluid or tissue of the esophagus by the sample collection unit of the imaging capsule.

14. The method according to claim 11, wherein the imaging capsule is shaped to define a bore thereof, and comprising placing the elongate carrier within the bore of the imaging capsule.

15. The method according to claim 11, wherein mounting the anchor member comprises inflating the anchor member when it is in the stomach.

16. The method according to claim 11, wherein mounting the anchor member comprises expanding the anchor member when it is in the stomach.