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07/13/06 - USPTO Class 606 |  59 views | #20060155261 | Prev - Next | About this Page  606 rss/xml feed  monitor keywords

Systems and methods for treating tissue regions of the body

USPTO Application #: 20060155261
Title: Systems and methods for treating tissue regions of the body
Abstract: Systems and methods deploy a therapeutic or diagnostic element into contact with a body tissue region. The systems and methods can sense position of the therapeutic or diagnostic element relative to a targeted tissue region without direct or indirect visualization, by sensing fluid pressure in a fluid path having an outlet located at or near the therapeutic or diagnostic element. The systems and methods can also inflate the therapeutic or diagnostic element during use, while taking steps to avoid over-inflation and/or while dynamically monitoring the pressure conditions within the expanded element. (end of abstract)



Agent: Ryan Kromholz & Manion, S.c. - Milwaukee, WI, US
Inventors: Robin Bek, Scott H. West, Patrick Rimroth
USPTO Applicaton #: 20060155261 - Class: 606001000 (USPTO)

Related Patent Categories: Surgery, Instruments

Systems and methods for treating tissue regions of the body description/claims


The Patent Description & Claims data below is from USPTO Patent Application 20060155261, Systems and methods for treating tissue regions of the body.

Brief Patent Description - Full Patent Description - Patent Application Claims
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RELATED APPLICATIONS

[0001] This application claims the benefit under 35 U.S.C. 120 of copending U.S. patent application Ser. No. 09/955,915, filed Sep. 19, 2001, and entitled "Devices, Systems, and Methods for Treating Tissue Regions of the Body," which is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The invention is directed to devices, systems and methods for treating tissue regions of the body.

BACKGROUND OF THE INVENTION

[0003] Catheter-based devices that deploy expandable structures into interior body regions are well known. These structures are typically introduced through a body lumen or vessel in a collapsed, low profile condition. Once at or near the targeted body region, the structures are expanded in situ into an enlarged condition to make contact with tissue. The structures can carry operative elements that, when in contact with tissue, perform a therapeutic or diagnostic function. They can, for example, deliver energy to ablate targeted tissue in the region.

[0004] Some of these structures can be expanded by inflation by delivery of fluid into the interior of the structure. It is desirable to control the amount of inflation, so as not to over-inflate the structures. Over-inflation can lead to damage of the structure, or unintended trauma or damage to nearby tissue.

[0005] With structures that are expanded in situ, it is also desirable to ascertain whether the structure actually is in contact with the targeted tissue region. Absent such contact, the desired therapeutic or diagnostic outcome may not be achieved.

SUMMARY OF THE INVENTION

[0006] The invention provides improved systems and methods for treating a tissue region.

[0007] One aspect of the invention provides systems and methods for sensing the position of a therapeutic or diagnostic element with respect to a targeted tissue region. The systems and methods comprise a fluid path having an outlet located at or near the therapeutic or diagnostic element. The location of the outlet places the outlet into a position with respect to the targeted tissue region concurrently with the therapeutic or diagnostic element. The systems and methods also include a source of fluid under pressure. The source is in communication with the fluid path to convey fluid under pressure through the fluid path. The systems and methods include a fluid pressure sensor, which communicates with the fluid path to sense prevailing fluid pressure in the path. The systems and methods also include an output to indicate the sensed prevailing fluid pressure or changes in the sensed prevailing fluid pressure over time. The sensed pressure conditions correlate with the position of the therapeutic or diagnostic element relative to the targeted tissue region. In one embodiment, the source of fluid conveys air under pressure, and the fluid pressure sensor comprises a manometer.

[0008] According to this aspect of the invention, changes in tissue pressure at or near the path outlet governs fluid flow in the path and gives rise to changes in fluid pressure within the path. Changes in the prevailing fluid pressure can be correlated to the position of the path outlet relative to a targeted tissue region. This aspect of the invention makes possible the sensing of the position of a remote structure with respect to a targeted tissue region without direct or indirect visualization, or without other complicated electrical or mechanical paraphernalia.

[0009] Another aspect of the invention provides systems and methods for inflating an inflatable structure that carries a therapeutic or diagnostic element. The systems and methods comprise a source of fluid under pressure. A supply line communicates with the inflatable structure and the source to convey fluid into the inflatable structure to inflate the inflatable structure for use. The systems and methods include a pressure relief valve. The pressure relief valve communicates with the supply line. The pressure relief valve opens and vents fluid from the supply line when a predetermined pressure condition exists in the supply line. This pressure condition is indicative that a desired interior pressure exists within the inflatable structure. This aspect of the invention assures that the inflatable structure is not subject to over-inflation during use.

[0010] Another aspect of the invention provides systems and methods for dynamically monitoring pressure conditions within an inflatable structure that carries a therapeutic or diagnostic element. The systems and methods include a pressure sensing element that dynamically senses interior pressure within the inflatable structure and generates an output. The sensing can be accomplished in real time, with an appropriate output generated to provide visual or audible feedback to the operator, and/or provide automated process control feedback based upon the sensed pressure information. The use of a dynamic pressure sensing element makes possible the automated inflation of an inflatable body in a straightforward and reliable manner. The use of dynamic pressure monitoring and control also facilitates the use of a porous balloon structure. The porous balloon structure is inflated to a desired pressure condition by the delivery of a liquid, while a portion of the inflation liquid is discharged through pores in the balloon, to provide a desired flow of irrigation fluid to the tissue region concurrent with inflation.

[0011] Other features and advantages of the inventions are set forth in the following Description and drawings, as well as in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. 1 is a schematic view of a system for treating tissue.

[0013] FIG. 2 is an enlarged view of the treatment device, with parts broken away and in section, that is associated with the system shown in FIG. 1, the treatment device comprising basket structure that carries selectively deployable electrode elements and that expands in response to inflation of an interior balloon structure, FIG. 2 showing the basket in a collapsed condition with the electrode elements retracted.

[0014] FIG. 3 is an enlarged view of the treatment device shown in FIG. 2, with the basket expanded due to inflation of interior balloon structure and the electrode elements still retracted.

[0015] FIG. 4 is an enlarged view of the treatment device shown in FIG. 2, with the basket expanded due to inflation of interior balloon structure and the electrode elements extended for use, FIG. 4 also showing the passage of irrigation fluid from the basket to cool the surface tissue while radio-frequency energy is applied by the electrode elements to subsurface tissue.

[0016] FIGS. 5 to 7 are simplified anatomic views showing the use of the treatment device shown in FIGS. 2 to 4 deployed in the region of the lower esophageal sphincter to form an array of lesions.

[0017] FIGS. 8 and 9 show, in simplified anatomic and schematic views, a system and method for sensing the position of the treatment device shown FIGS. 2 to 4 with respect to a targeted tissue region, by sensing fluid pressure in a fluid path having an outlet located at or near the electrode elements.

[0018] FIGS. 10 to 13 show, in perspective views, a system and method for manually inflating the balloon structure in the treatment device shown in FIGS. 2 to 4 while tactilely monitoring the magnitude of the inflation pressure to avoid over-inflation of the balloon structure.

[0019] FIGS. 14 and 15 show, in perspective views, a system and method for manually inflating the balloon structure in the treatment device shown in FIGS. 2 to 4 while using a pressure relief valve to avoid over-inflation of the balloon structure.

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