Systems and methods for treating dysfunctions in the intestines and rectum that adapt to the anatomic form and structure of different individuals

• US 9,204,926 B2
• Filed: 03/15/2014
• Issued: 12/08/2015
• Est. Priority Date: 02/19/1998
• Status: Expired due to Fees

• Current Assignee: Mederi Rf, LLC
• Original Assignee: Mederi Therapeutics, Inc. (Respiratory Technology Corp.)
• Inventors: West, Scott H., Gaiser, John W., Rimroth, Patrick, Heaton, Larry C.
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): Zink, Amanda
• Application Number:
  US14/214,880
• Publication Number:
  US 20140200403A1
• Time in Patent Office: 633 Days
• Field of Search: 606 27- 52
• US Class Current: 1/1
• CPC Class Codes: A61B 1/00029 externally powered, e.g. wireless
• CPC Class Codes: A61B 1/00066 Proximal part of endoscope body, e.g. handles A61B1/0052 takes precedence
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/00094 Suction openings
• CPC Class Codes: A61B 1/00133 Drive units for endoscopic tools inserted through or with the endoscope
• CPC Class Codes: A61B 1/012 characterised by internal passages or accessories therefor
• CPC Class Codes: A61B 1/0661 Endoscope light sources
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 1/31 for the rectum, e.g. proctoscopes, sigmoidoscopes , colonoscopes
• CPC Class Codes: A61B 1/32 Devices for opening or enlarging the visual field, e.g. of a tube of the body dilators A61M29/00
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00482 Digestive system
• CPC Class Codes: A61B 2018/00494 Stomach, intestines or bowel
• CPC Class Codes: A61B 2018/00553 Sphincter
• CPC Class Codes: A61B 2018/00797 measured by multiple temperature sensors
• CPC Class Codes: A61B 2018/0091 Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/143 : multiple needles
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/3782 : transmitter or receiver in catheter or minimal invasive instrument
• CPC Class Codes: A61B 2218/007 : Aspiration

Abstract

A family of barrel structures is provided in a kit. Each barrel structure is differently sized and configured for advancement into anal canals of different anatomic morphologies. Instructions are provided for using the barrel structures to treat an individual. The instructions instruct assessing an anatomic morphology of an anal canal of an individual to be treated and selecting one of the barrel structures based upon the assessed anatomic morphology. Each barrel structure carries an electrode sized and configured to be coupled to a source of tissue ablation energy to be applied through the electrode to form a lesion. Each barrel structure includes a transparent side wall visualized by a direct line of sight from an end portion of the first barrel structure. The instructions instruct inserting the selected barrel structure into the anal canal and visualizing by the direct line of sight through the transparent side wall of the selected barrel structure the dentate line and the targeted tissue region. The instructions instruct, while visualizing, aligning the electrode in a desired location in the targeted tissue region above the dentate line, advancing the electrode to penetrate tissue at or near a sphincter, and applying energy through the electrode to create a lesion in the sphincter.

Claims

1. A device for treating tissue in the anal canal to treat fecal incontinence, the device comprising

a handle portion;

a tubular barrel extending from the handle portion and sized and configured for insertion into the anal canal through an anal orifice, the barrel having a proximal portion and a distal portion and terminating in a blunt tip, the barrel further including an array of openings at the distal portion, the array of openings arranged along an arcuate segment of the barrel, wherein the device includes a viewing port at the proximal portion in line with a hollow interior of the barrel to enable a user to look into the hollow interior of the barrel from the proximal portion;

an array of needle electrodes with penetrating tips, the needle electrodes advanceable from a first position within the barrel to a second extended position so the penetrating tips extend radially from the barrel to pierce sphincter muscle above the dentate line; and

an actuator for advancing the needle electrodes, the needle electrodes mounted along the arcuate segment of the barrel, the barrel enabling visualization of the target tissue within the anal canal via the viewing port, and the needle electrodes applying energy to the sphincter muscle to treat tissue in the anal canal to treat fecal incontinence, wherein the needle electrodes are biased with an antegrade bend and are bent in a same direction with respect to the arcuate segment.

2. The device of claim 1, wherein the handle portion extends at an angle to the barrel.

3. The device of claim 1, further comprising a light pipe extending through the barrel for illuminating the distal portion of the barrel, wherein the light pipe is couplable to a light source to illuminate the distal portion of the barrel.

4. The device of claim 1, further comprising an electrode carrier having a plurality of channels, the needle electrodes mounted within the channels of the carrier.

5. The device of claim 1, wherein the blunt tip of the barrel enables introduction of the barrel into the anal canal without need for a separate introducer.

6. The device of claim 1, wherein the handle portion includes a fitting fluidly communicating with a fluid delivery apparatus, the fluid deliverable adjacent each needle electrode.

7. The device of claim 1, wherein the actuator is a finger operated pull lever.

8. The device of claim 1, wherein a wall of the barrel is transparent.

9. The device of claim 1, wherein the needle electrodes are locked in the extended position.

10. The device of claim 1, wherein the barrel includes a plurality of channels, and the needle electrodes are movable within the channels.

11. The device of claim 10, wherein a fluid manifold is carried by the barrel distal to a termination of the channels.

12. The device of claim 1, further comprising a plurality of wires extending through the barrel and connected to the needle electrodes.

13. The device of claim 1, wherein the apparatus includes a fitting couplable to an aspirating apparatus, and liquid is aspirated through a distal opening in the barrel.

14. The device of claim 1, further comprising a plurality of temperature sensing elements carried by the barrel.

15. A device for treating tissue in the anal canal to treat fecal incontinence, the device comprising

a handle portion;

a tubular barrel extending from the handle portion and sized and configured for insertion into the anal canal through an anal orifice, the barrel having a proximal portion and a distal portion and terminating in a blunt tip, the barrel further including an array of electrode receiving openings at the distal portion, the array of electrode receiving openings arranged along an arcuate segment of the barrel, the tubular barrel having a central longitudinal axis, and the array of electrode receiving openings formed on only a first side of the central longitudinal axis, the tubular barrel defining a first surface and a second surface on opposing sides of the central longitudinal axis, the first surface being on the first side, the handle portion extending at an angle from the first surface, and the electrode receiving openings along the arcuate segment extending only about the first surface;

an array of needle electrodes with penetrating tips and having a bend, the needle electrodes advanceable from a first position within the barrel to a second extended position so the penetrating tips extend radially from the barrel in a curved fashion in a same bent direction with respect to the arcuate segment to pierce sphincter muscle above the dentate line, the needle electrodes extending through the electrode receiving openings on only the first side of the barrel so that they are capable of extending from only one side of the barrel; and

an actuator for advancing the needle electrodes, the needle electrodes mounted along the arcuate segment of the barrel enabling visualization of the target tissue within the anal canal, and the needle electrodes advanceable to the second position so tips of the needle electrodes are arranged in an arcuate fashion, the needle electrodes applying energy to the sphincter muscle to treat tissue in the anal canal to treat fecal incontinence.

16. The device of claim 15, wherein the handle portion includes a fitting fluidly communicating with a fluid delivery apparatus, the fluid deliverable adjacent each needle electrode.

17. The device of claim 15, further comprising a plurality of temperature sensing elements carried by the barrel.

18. The device of claim 17, wherein the temperature sensors are used to control radiofrequency energy applied by the needle electrodes to the tissue.