Tissue treatment
Inventors
Sverdlik, Ariel • Zadok, Yehuda • Shabtay, Or • Szwarcfiter, Iris • Schauder, Avital • Rocha-Singh, Krishna J.
Assignees
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Publication Number
US-10357304-B2
Publication Date
2019-07-23
Expiration Date
Abstract
There is provided in accordance with an exemplary embodiment of the invention a method and/or a device of treating tissue near a first lumen comprising inserting an energy emission element into a second lumen and delivering energy in an amount sufficient to cause one or more spaced apart areas of tissue damage at preselected locations in tissue near the first lumen. There is also provided a method and/or a device for treating a carotid artery wall, for example, to reduce signal conduction. There is also provided a method and/or a device for treating a wall of a lumen in a limb, for example, to increase blood flow. There is also provided a method and/or a device for treating a wall of a heart, for example, to stop abnormal signal propagation.
Core Innovation
The invention relates to a method of treating tissue in a lumen wall and/or surrounding tissue by inserting a catheter that includes an energy emission element into a region of a lumen containing a deployed stent with a portion placed in direct contact with an intima of the lumen wall. Energy is selectively applied from within the lumen so that a beam from the energy emission element crosses the stent-contacting portion to form one or more spaced apart regions of tissue damage in the lumen wall or surrounding tissue without damaging the intima in direct contact with the portion.
In the disclosed approach, energy delivery is ultrasound-based, using an unfocused ultrasound pencil beam and, in some cases, one or more additional ultrasound emission elements to emit unfocused ultrasound beams toward multiple different directions. Targeting produces spaced apart regions at preselected locations near a first lumen using energy emitted from within a lumen region that contains a deployed stent, while maintaining protection of the intima/endocardium.
The disclosure also emphasizes preserving relevant tissue layers where intended and mitigating undesired effects associated with the stent. Cooling is addressed by using blood flow through the lumen, including selecting blood flow at a level high enough to cool the stent, and a lumen support/propping device is described to maintain clearance for cooling and to prevent beam source-wall contact without damaging vessel walls.
Claims Coverage
The partial content includes one independent claim. It covers catheter-based delivery of ultrasound energy from within a lumen containing a deployed stent, with selective parameter selection that treats the tissue as if the stent were not present, and with avoidance of intima damage at the stent-contacting portion; dependent claims further narrow the inventive concept using specific ultrasound and beam features, tissue targets, and additional constraints such as cooling by blood flow and avoiding stent deformation, plus optional stent detection via ultrasonic echo.
Stent-contact-intima tissue protection with in-lumen energy crossing the stent portion
Inserting a catheter including an energy emission element into a region of a lumen containing a deployed stent having a portion placed in direct contact with an intima, and selectively applying energy from within the lumen so that a beam crosses said portion to form one or more spaced apart regions of tissue damage in the lumen wall or surrounding tissue without damaging the intima in direct contact with said portion.
Treatment parameters selected as if the deployed stent was not present
Selectively applying energy comprises selecting treatment parameters as if said deployed stent were not present.
Unfocused ultrasound beam as the delivered energy
The energy emission element includes an ultrasound emission element and the applied beam is a beam of unfocused ultrasound.
Multiple unfocused ultrasound emission directions
Adding one or more ultrasound emission elements that each emit unfocused ultrasound beams directed toward multiple different directions.
Cooling by selecting blood flow level through the lumen
Selecting blood flow through the lumen at a level high enough to cool the stent.
Avoiding stent deformation during selective energy application
Selectively applying energy so that the stent is not deformed.
Spaced-apart tissue damage including nerves
The one or more spaced apart regions of tissue damage include nerves.
Across the independent claim and its dependent refinements, the inventive coverage is anchored in selectively applying energy from within a lumen to produce spaced-apart tissue-damage regions while protecting the stent-contacting intima, where the treatment parameters are selected as if the deployed stent were not present. The dependent features further specify unfocused ultrasound delivery, nerve-inclusive targets, cooling by blood flow, avoiding stent deformation, and optional ultrasonic stent detection.
Stated Advantages
Creates spaced apart regions of tissue damage in the lumen wall or surrounding tissue without damaging the intima in direct contact with the stent portion.
Enables treatment parameter selection as if the deployed stent were not present.
Provides cooling by selecting blood flow level high enough to cool the stent.
Avoids stent deformation during selective energy application.
Supports stent treatment with compensation and ultrasonic stent detection via ultrasonic echo.
Documented Applications
Carotid sinus denervation to decrease signal propagation, including treatment of carotid artery, carotid sinus, and baroreceptors.
Limb denervation to increase blood flow, including increasing blood flow in a limb.
Renal denervation, including decreasing norepinephrine via renal denervation.
Heart wall ablation to stop abnormal conduction, including creating myocardial damage without endocardial damage.
Treatment where ultrasound is delivered through deployed stents, including through deployed stents with stent-contact intima protection as described.
Stent-related treatment modes including compensation and ultrasonic stent detection via ultrasonic echo.
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