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

• US 8,696,661 B2
• Filed: 12/20/2007
• Issued: 04/15/2014
• 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 J., Heaton, Larry C. II
• Primary Examiner(s): Dvorak, Linda
• Assistant Examiner(s): Scott, Amanda
• Application Number:
  US12/004,189
• Publication Number:
  US 20080103498A1
• Time in Patent Office: 2,308 Days
• Field of Search: 606 27- 52
• US Class Current: 606/41
• 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 kit for the treatment of fecal incontinence comprising

a first handle component contained in a first package;

a first barrel structure contained in the first package as a separate unit from the first handle component and capable of being attached to the first handle component by a user, said first barrel component sized and configured with a first dimension conducive for advancement into an anal canal having a first anatomic morphology, the first barrel structure carrying 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, the first barrel structure including a transparent side wall visualized by a direct line of sight from an end portion of the first barrel structure,

a second barrel structure contained in the first package as a separate unit from the first handle component and first barrel structure and capable of being attached to the first handle component by a user independently and alternatively of said first barrel structure, said second barrel component sized and configured with a second dimension different than the first dimension, the second dimension being conducive for advancement into an anal canal having a second anatomic morphology different than the first anatomic morphology, the second barrel structure carrying 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, the second barrel structure including a transparent side wall visualized by a direct line of sight from an end portion of the second barrel structure,

instructions for using either of the selected first or second barrel structure to treat an individual comprising assessing an anatomic morphology of an anal canal of an individual to be treated;

selecting one of the first and second barrel structures based upon the assessed anatomic morphology, inserting the selected barrel structure into the anal canal with the electrode retracted within the selected barrel structure;

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;

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.

2. A kit according to claim 1

wherein the first handle component includes a frame component.

3. A kit according to claim 1

wherein the instructions include coupling the selected barrel structure to the handle component prior to inserting the selected barrel structure into the anal canal.

4. A kit according to claim 1

wherein the instructions include aspirating fluid at or near the sphincter.

5. A kit according to claim 1

wherein the instructions include sensing tissue temperature during creation of the lesion.

6. A kit according to claim 1

wherein the instructions include manipulating the selected barrel structure to create a composite lesion pattern at or near the sphincter.

7. A kit for the treatment of fecal incontinence comprising;

a first handle component;

a first barrel attachable to the first handle component, the first barrel having a first barrel size and including a temperature sensing device and an electrode to provide energy to create a lesion pattern to treat fecal incontinence;

a second barrel attachable to the first handle component, the second barrel having a second barrel size and including a temperature sensing device and an electrode to provide energy to create a lesion pattern to treat fecal incontinence;

wherein either the first or second barrel is selectively attachable to the first handle component by a user to enable the user to select one of the two different barrel sizes for attachment to the first handle component.

8. A kit according to claim 7, wherein each barrel includes electrodes movable within the barrel.

9. A kit according to claim 8, wherein the first and second barrels are configured for single use.

10. A kit according to claim 7, wherein the first handle component includes a frame component extending transversely to a handle, and the first and second barrels include an elongated slot to form a canopy configuration, the first and second barrels attachable to the frame component.

11. A kit according to claim 10, wherein the first and second barrels are attachable to a slide on track of the frame component.

12. A kit according to claim 10, wherein an attached barrel and frame component have a round or oval cross section.