Embodiments related to cryogenically ablating a portion of the inner surface of a vessel by constraining a cryoballoon using various apparatuses and methods are disclosed. For example, a catheter can include a cryoballoon for ablation of the vessel wall and a constraining element disposed substantially in parallel with the cryoballoon to deflect or offset a portion of the cryoballoon away from non-target tissue of the vessel wall and prevent ablation of the non-target tissue. Partial circumferential, non-continuous, or helical ablation can be effective for treating a variety of renal, cardio-renal, and other diseases including but not limited to hypertension, heart failure, renal disease, renal failure, contrast nephropathy, arrhythmia, and myocardial infarction. The constraining element may be, for example, a second inflatable balloon or one or more self-expanding prongs.
Drawings
Claims19
A cryotherapeutic device, comprising:
an elongate shaft having a distal end portion, wherein the shaft is configured to locate its distal end portion at a treatment site within an anatomical lumen of a human patient;
a first balloon at the distal end portion of the shaft, wherein the first balloon includes a flexible wall defining an expandable interior volume;
a first supply lumen carried by the shaft;
a first exhaust lumen carried by the shaft, wherein the first exhaust lumen is fluidly connected to the first supply lumen via the interior volume of the first balloon;
a second balloon at the distal end portion of the shaft, wherein the second balloon includes a flexible wall defining an expandable interior volume fluidly separate from the first supply lumen and from the first exhaust lumen, and wherein the second balloon is configured to prevent the first balloon from contacting a full circumference of a wall of the anatomical lumen in any plane perpendicular to a length of the anatomical lumen;
a second supply lumen carried by the shaft;
and
a second exhaust lumen carried by the shaft, wherein the second exhaust lumen is fluidly connected to the second supply lumen via the interior volume of the second balloon, and wherein the respective interior volumes of the first and second balloons are non-overlapping.
5 more elements
A method for treating a patient, the method comprising:
locating a distal end portion of an elongate shaft of a cryotherapeutic device at a treatment site within an anatomical lumen of the patient;
supplying refrigerant to a first balloon of the cryotherapeutic device at the distal end portion of the shaft;
expanding the refrigerant within an interior volume defined by a flexible wall of the first balloon;
cooling a first portion of a wall of the anatomical lumen via the wall of the first balloon;
supplying heat-transfer fluid to a second balloon of the cryotherapeutic device at the distal end portion of the shaft;
flowing the heat-transfer fluid through an interior volume defined by a flexible wall of the second balloon, wherein the respective interior volumes of the first and second balloons are non-overlapping while flowing the heat-transfer fluid through the interior volume of the second balloon;
and
warming a second portion of the wall of the anatomical lumen via the wall of the second balloon,
wherein a plane perpendicular to a length of the anatomical lumen intersects the first balloon, the second balloon, the first portion of the wall of the anatomical lumen, and the second portion of the wall of the anatomical lumen while cooling the first portion of the wall of the anatomical lumen and while warming the second portion of the wall of the anatomical lumen.
14/114,345Filed 12 Jun 2014 · us provisional application
Priority
25 Apr 2011
Published
US 2015/0126986 A17 May 2015
Granted
17 Mar 2020
Term ends
10 Aug 2038Estimated · howhide20 years from earliest known nonprovisional domestic filing plus recorded patent term adjustment, including 1,520 days of adjustment. Maintenance-fee lapses, terminal disclaimers and statutory extensions have not been checked. The continuity chain may be incomplete; this is not an enforceability determination.
Balloons: adapted to separate target tissue from other tissue
Life of this patent
About 11 years 9 months of term left · ends 10 Aug 2038 (estimated)
Priority25 Apr 2011
Filed12 Jun 2014
Published7 May 2015
Granted17 Mar 2020
Today12 Oct 2026
Term ends10 Aug 2038
Priority25 Apr 2011
Granted17 Mar 2020
Term ends10 Aug 2038
Priority claimedParent application 61/572,288
Application filedUS 14/114,345
PublishedUS 2015/0126986 A1
Assigned to Medtronic Ardian Luxembourg S.A.R.L.assignment of assignor's interest
GrantedUS 10,588,682 B2
TodayWithin its term
Term endsEstimated, includes 1,520 days of adjustment
Description10,747 words
Summary206 words
#The present technology relates in general to cryotherapy, and in particular, to apparatus and methods for cryogenically cooling a targeted area of an inner surface of an anatomical vessel or other tissue.
#Cryotherapy can be a useful treatment modality in a wide range of catheter-based interventional procedures. For example, cryotherapeutic cooling can be used to modulate nerves or affect other tissue proximate anatomical vessels (e.g., blood vessels, other body lumens, or other areas in the body). This can reduce undesirable neural activity to achieve therapeutic benefits. Catheter-based neuromodulation utilizing cryotherapy can be used, for example, to modulate nerves and thereby reduce pain, local sympathetic activity, systemic sympathetic activity, associated pathologies, and other conditions. Furthermore, cryotherapy can be used, for example, for ablating tumors and treating stenosis. In some cryotherapeutic procedures, it can be useful to deliver cryotherapy via a balloon that can be expanded within an anatomical vessel. Such balloons can be operatively connected to extracorporeal support components (e.g., refrigerant supplies). As the applicability of cryotherapy for surgical intervention continues to expand, there is a need for innovation in the associated devices, systems, and methods. Such innovation has the potential to further expand the role of cryotherapy as a tool for improving the health of patients.
Brief description of the drawings32 figures
#Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology.
#FIG. 1 is a partially schematic isometric detail view of a common location of neural fibers proximate an artery.
#FIG. 2 is a partially schematic cross-sectional view of an artery having an ablation assembly deployed therein, wherein the ablation assembly includes a cryoballoon and a constraining element that can position the cryoballoon within the artery.
Detailed description9,665 words
#Specific embodiments of the present technology are now described with reference to the figures, wherein like reference numbers indicate identical or functionally similar elements. The terms “distal” and “proximal” are used in the following description with respect to a position or direction relative to the treating clinician. “Distal” and “distally” refer to positions distant from or in a direction away from the clinician. “Proximal” and “proximally” refer to positions near or in a direction toward the clinician.
#The following detailed description discloses specific examples of the technology, but it is not intended to limit the present technology or the application and uses of the present technology. For example, although the description discloses the present technology in the context of treatment of blood vessels, such as renal arteries, the present technology may also be used in any other body passageways or tissues where it is deemed useful. Furthermore, there is no intention to be bound by any expressed or implied theory presented herein.
#In recent years, ablation of tissue has been used to modulate neural fibers that contribute to renal function. Ablation may be accomplished in various ways, including delivery of radio frequency (RF) energy, other suitable heating energies, or cryotherapy. Modulation of renal nerves is expected to be useful in treating a variety of renal, cardio-renal, and other diseases including heart failure, renal disease, renal failure, hypertension, contrast nephropathy, arrhythmia, and myocardial infarction. Furthermore, renal neuromodulation is expected to reduce renal sympathetic nervous activity, which can increase removal of water and sodium from the body and return renin secretion to more normal levels. Normalized renin secretion can cause blood vessels supplying the kidneys to assume a steady state level of dilation and constriction corresponding to adequate renal blood flow.