Patent Application
20170143403
Technical Field
The present disclosure relates to treatment of Inflammatory Bowel Diseases (IBDs) and, more particularly, to surgical instruments and methods for treating ulcerative colitis and other IBDs, e.g., Crohn's Disease.
Background of Related Art
Ulcerative colitis, an IBD, is a disease of the colon in which inflammation and ulcers, or sores, form on the interior wall of the colon. Ulcerative colitis manifests itself, usually intermittently and at varying degrees of severity, in symptoms such as stomach pain, diarrhea, and/or bloody stool. Typically, anti-inflammatory medication(s) are prescribed for patients suffering from ulcerative colitis. In extreme cases, chronic cases, or cases in which medication(s) fails to adequately treat the patient's symptoms, surgery to remove all or part of the diseased portions of the rectum and/or colon may be performed.
Although medication(s) and surgical removal of diseased portions of the rectum and/or colon are effective in certain instances, there is a need for surgical instruments, systems, and methods to more effectively and/or efficiently treat ulcerative colitis and other IBDs, e.g., Crohn's Disease, while minimizing side effects and damage to un-diseased tissue.
As used herein, the term “distal” refers to the portion that is being described which is further from a user, while the term “proximal” refers to the portion that is being described which is closer to a user. Further, to the extent consistent, any of the aspects described herein may be used in conjunction with any or all of the other aspects described herein.
A surgical instrument provided in accordance with the present disclosure includes a flexible tube defining a proximal end and a distal end. An end effector, disposed at the distal end of the flexible tube, is configured for insertion into and advancement through a body cavity to a treatment target. The end effector is adapted to connect to a source of energy. The end effector includes an expandable member which can expand from an un-expanded state to an expanded state in order to circumferentially contact a bodily treatment target. The end effector further includes at least one heating member configured to heat the expandable member such that the expandable member is enabled to thermally treat tissue in contact therewith.
In an aspect of the present disclosure, the expandable member is an inflatable balloon. Further, the heating member may include a laser source disposed within the inflatable balloon. The laser source is configured to emit laser light onto the inflatable balloon and the inflatable balloon is configured to absorb the laser light, thereby heating the inflatable balloon.
In yet another aspect of the present disclosure, the expandable member is an inflatable balloon and the heating member is composed of one or more ultrasonic devices. The ultrasonic devices emit high frequency ultrasonic waves. The inflatable balloon is configured to absorb the ultrasonic waves, thereby heating the inflatable balloon.
In still another aspect of the present disclosure, the expandable member is an inflatable balloon and the heating member is a thermoelectric cooler. The thermoelectric cooler is disposed about the inflatable balloon.
In another aspect of the present disclosure, the expandable member is an inflatable balloon and the heating member is a conductive coating disposed on the expandable balloon. The conducting coating is configured to receive an electric current and generate heat through resistive heating.
In an additional aspect of the present disclosure, the expandable member is an expandable ring and the heating member includes a fluid chamber configured to heat fluid. The heated fluid is pumped into the expandable ring causing the expandable ring to expand and heat. As an expandable ring expands, it contacts a treatment site and transfers heat to the treatment site for thermal treatment thereof.
In yet another aspect of the present disclosure, the expandable member includes an expandable basket, and the heating member includes a plurality of wire components composing a portion of the expandable basket. The plurality of wire components is configured to receive electric current and produce heat through resistive heating. The expandable basket further includes a joint interconnecting at least two of the wire components. The joint is configured to flex and expand the expandable basket in response to energy conduction through the joint.
A method of treating tissue is also provided in accordance with the present disclosure. The method includes inserting a flexible tube having an end effector disposed at a distal end thereof into a body cavity, positioning the end effector adjacent a treatment target, expanding the end effector from an un-expanded state to an expanded state, and heating the end effector sufficiently so as to thermally treat tissue via conductive heating.
Certain embodiments of the present disclosure may include some, all, or none of the above aspects. Further, to the extent consistent, any of the aspects described herein may be used in conjunction with any or all of the other aspects described herein.
Various aspects and features of the present disclosure described herein with reference to the drawings wherein:
As IBD's such as ulcerative colitis may only affect portions of the colon, it is desirable to focus treatment towards such diseased areas while limiting damage to surrounding tissue and critical structures. Accordingly, the present disclosure provides various instruments and methods configured to facilitate the focused or controlled energy-based treatment of diseased portions of the colon while limiting damage to surrounding portions of the colon and other surrounding tissue and critical structures. The various embodiments of the present disclosure may be implemented using a variety of types of energy, e.g., RF, microwave, ultrasonic, thermal, etc. Further, although the various instruments and methods provided herein may be utilized to treat any suitable type of diseased tissue, particular reference will be made to the colon.
Referring to
With reference to
Flexible tube 23 extends distally from housing 21 to end effector 200. End effector 200 includes probe 201 connected to flexible tube 23 and extending distally therefrom to distal end 28. End effector 200 further includes an inflatable balloon 202 composed of material that heats when laser light is applied, e.g. silicon, germanium, indium phosphate. Inflatable balloon 202 is disposed about probe 201 and configured to expand relative to probe 201 from the un-expanded state to the expanded state to conform to the interior anatomy of the colon “C.”
Button 25 controls the flow of fluid between supply line 27 and inflatable balloon 202. When button 25 is activated in a first position, fluid flows from the fluid source (not shown) through supply line 27 and flexible cable 23 into inflatable balloon 202 causing inflatable balloon 202 to inflate. When button 25 is activated in a second position, fluid flows from inflatable balloon 202 through flexible cable 23 and supply line 27 to the fluid source (not shown), causing inflatable balloon 202 to deflate.
Shaft 201 is configured to emit laser light 210 onto the interior surface of inflatable balloon 202, e.g., via apertures, slots, or other suitable openings formed in probe 201. The laser light 210 is configured to be absorbed by inflatable balloon 202 such that inflatable balloon 202 is heated. Button 24 controls the supply of laser light 210 to probe 201. When button 24 is activated, it allows laser light to travel from a laser light source (not shown) through cable 26 to probe 201. When button 24 is released or deactivated, it ceases to allow laser light 210 to be supplied to probe 201.
With reference to
Referring to
With additional reference to
However, different from end effector 200, once balloon 302 is positioned as detailed above, button 24 may be activated to supply energy from a power source (not shown) connected to cable 26, through flexible tube 23, to ultrasonic devices 303. Ultrasonic devices 303 convert the energy into mechanical motion (e.g., ultrasonic vibrations) that are emitted from probe 301 within balloon 302 in the form of ultrasonic waves. These ultrasonic waves ultimately reach balloon 302 and are absorbed by balloon 302, causing balloon 302 to be heated. Similarly as above, heating of balloon 302 conductively heats treatment target 211 on the colon wall “W.” Treatment target 211 is heated sufficiently, e.g., via controlling the application of energy to ultrasonic devices 303, so as to treat the diseased tissue, e.g., via burning, charring, ablating, coagulating, and/or desiccating the diseased tissue. By thermally treating the tissue in this manner, inflammation and ulceration can be reduced or eliminated entirely, thereby reducing associated pain and discomfort. Further, during use, end effector 300 may be advanced or retracted through colon “C” to contact the entire length of treatment target 211 and treat the same with the heated balloon 302.
Referring to
With additional reference to
Once the above has been achieved, button 24 may be activated to supply energy from a power source (not shown) connected to cable 26, to conductive coating 403. Upon application of energy to conductive coating 403, conductive coating 403 is heated, thereby conductively heating tissue of the treatment target 211 in contact therewith. Treatment target 211 is heated sufficiently, e.g., via controlling the application of energy to conductive coating 403, so as to treat the diseased tissue, e.g., via burning, charring, ablating, coagulating, and/or desiccating the diseased tissue. By thermally treating the tissue in this manner, inflammation and ulceration can be reduced or eliminated entirely, thereby reducing associated pain and discomfort. Further, during use, end effector 400 may be advanced or retracted through colon “C” to contact the entire length of treatment target 211 and treat the same.
Referring to
With additional reference to
Thereafter, button 24 is activated to supply energy from a power source (not shown), to thermoelectric cooler 503 via cable 26. Through the Peltier effect, as noted above, the outwardly-oriented “hot side” of thermoelectric cooler 503 is heated, thereby conductively heating the treatment target 211 in contact therewith. Treatment target 211 is heated sufficiently, e.g., via controlling the application of energy to thermoelectric cooler 503, so as to treat the diseased tissue, e.g., via burning, charring, ablating, coagulating, and/or desiccating the diseased tissue. By thermally treating the tissue in this manner, inflammation and ulceration can be reduced or eliminated entirely, thereby reducing associated pain and discomfort. Further, during use, end effector 500 may be advanced or retracted through colon “C” to contact the entire length of treatment target 211 and treat the same.
Referring to
Surgical instrument 60 generally includes a housing 61, an end effector 600, a flexible tube 64, a button 65, a fluid chamber 62, and a fluid line 63. Flexible tube 64 extends distally from housing 61 to end effector 600. End effector 600 includes an expandable ring 601 connected to fluid line 63 and radially disposed about the distal end of flexible tube 64. Expandable ring 601 is configured to expand from an un-expanded state to an expanded state to conform to the interior anatomy of the colon “C” in response to the delivery of fluid thereto. Fluid chamber 62 may define a closed-loop system, or may be coupled to an external fluid source (not shown) for the inflow and/or outflow of fluid to/from fluid chamber 62. Further, fluid chamber 62 may be configured to heat fluid disposed therein.
Button 65 controls the flow of fluid between fluid chamber 62 and expandable ring 601. When button 65 is activated, fluid is pumped from fluid chamber 62 through fluid line 63 into expandable ring 601 under sufficient pressure so as to cause expandable ring 601 to expand. Fluid may be continually circulated between fluid chamber 62 and expandable ring 601, with expandable ring 601 in the expanded state, to maintain the fluid at a desired temperature, e.g., via heating and re-circulating the fluid within fluid chamber 62. When button 65 is released or de-activated, fluid is no longer pumped into expandable ring 601 and, as such, expandable ring 601 is returned to the un-expanded state.
In use, distal end 66 of surgical instrument 60 is advanced into the rectum “R” and through the bowel “B” such that flexible tube 64 and end effector 600 are advanced through the colon “C” until end effector 600 reaches treatment target 602. Button 65 is activated such that the heated fluid within fluid chamber 62 is pumped through fluid line into expandable ring 601, causing expandable ring 601 to expand to the expanded state in which expandable ring 601 conforms to the interior anatomy of treatment target 602, in circumferential contact therewith. In addition to expanding expandable ring 601, the heated fluid also serves to heat expandable ring 601 which, in turn, heats the treatment target 602 on the colon wall “W” through conduction. Treatment target 602 is heated sufficiently, e.g., via controlling the heating of fluid within fluid chamber 62 and/or the circulation thereof through fluid line 63 and expandable ring 601, so as to treat the diseased tissue, e.g., via burning, charring, ablating, coagulating, and/or desiccating the diseased tissue. By thermally treating the tissue in this manner, inflammation and ulceration can be reduced or eliminated entirely, thereby reducing associated pain and discomfort. Further, during use, end effector 600 may be advanced or retracted through colon “C” to contact the entire length of treatment target 602 and treat the same.
Referring to
With additional reference to
Once this position has been achieved, depending upon the size of the treatment target 602, the head of plunger 701 is advanced further into cylinder 702 towards distal end 703 thereof or retracted proximally within cylinder 702 towards proximal end 704 thereof. Thereafter, button 65 is activated to pump heated fluid, e.g., steam, from the fluid chamber 62 through plunger 701 and into the enclosed cylindrical volume between the head of plunger 701 and the closed distal end 703 of cylinder 702. The heated fluid, e.g., steam, within cylinder 702 conducts heat to cylinder 702 which, in turn, heat tissue in contact therewith and/or adjacent thereto to treat the diseased tissue, e.g., via burning, charring, ablating, coagulating, and/or desiccating the diseased tissue. By thermally treating the tissue in this manner, inflammation and ulceration can be reduced or eliminated entirely, thereby reducing associated pain and discomfort.
By changing the positioning of plunger 701 and, thus, the portion of cylinder 702 that is filled with the heated fluid, the treatment area can be broadened or narrowed. Further, during use, end effector 700 may be advanced or retracted through colon “C,” similarly as detailed above.
Referring to
End effector 800 includes an expandable basket 801 formed from a plurality of wire components 802, at least some of which are coupled to one another via a hinge, e.g., a hinge joint or living hinge. Wire components 802 may be composed of, for example, Nichrome, Kanthal, or other suitable materials capable of conducting energy therethrough and, during such conduction of energy, being expanded and generating heat via resistive heating. As an alternative to energy-based expansion, expandable basket 801 may be formed from resilient wire components 802 and/or may include resilient hinges to bias expandable basket 801 towards the expanded position while also allowing collapse of expandable basket 801 for insertion, removal, and/or maneuvering expandable basket 801 into position.
Button 82 controls the flow of energy between a power source (not shown) connected to cable 85 and expandable basket 801. More specifically, when button 82 is activated, energy is supplied to expandable basket 801 and conducted through wire components 802 (including the hinges thereof) to expand expandable basket 801 to the expanded position. Thereafter or in connection therewith, energy being conducted through wire components 802 serves to resistively heat wire components 802. Upon release or deactivation of button 25, energy is no longer supplied to expandable basket 801 and, thus, expandable basket 801 is returned to the un-expanded state while wire components 802 are permitted to cool.
With additional reference to
With wire components 802 in contact with treatment target 803, button 82 is maintained in the activated position such that the energy supplied to wire components 802 causes wire components 802 to be resistively heat and produce thermal energy that is conducted to treatment target 803 on the colon wall “W.” Treatment target 803 is heated sufficiently so as to treat the diseased tissue, e.g., via burning, charring, ablating, coagulating, and/or desiccating the diseased tissue. By thermally treating the tissue in this manner, inflammation and ulceration can be reduced or eliminated entirely, thereby reducing associated pain and discomfort. Housing 81 may be manipulated to advance or retract end effector 800, while in the expanded state, through colon “C” to contact the entire length of treatment target 803.
From the foregoing and with reference to the various figure drawings, those skilled in the art will appreciate that certain modifications may also be made to the present disclosure without departing from the scope of the same. While several embodiments of the disclosure have been shown in the drawings, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 62/258,081, filed on Nov. 20, 2015, the entire contents of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62258081 | Nov 2015 | US |
