CA2948821A1 - Medical system including elongate members with non-uniform spacing therebetween in expanded configuration - Google Patents

Abstract

A medical device system may include elongate members exhibiting non-uniform spacing therebetween in one or more expanded or deployed configurations, which may improve contact at least between (a) one or more portions of the elongate members or one or more transducers provided by one or more of the elongate members, and (b) one or more preferred regions of a tissue wall of a cavity of a bodily organ. In some embodiments, the non-uniform spacing is configured to align with one or more anatomical features of the tissue wall and, in some embodiments, to produce a preferred lesion pattern in order to effectively treat the bodily organ.

Description

MEDICAL SYSTEM INCLUDING ELONGATE MEMBERS WITH NON-UNIFORM
SPACING THEREBETWEEN IN EXPANDED CONFIGURATION
CROSS-REFERENCE TO RELATED APPLICATION(S) This application claims the benefit of U.S. Provisional Application No.
62/268,678, filed December 17, 2015, the entire disclosure of which is hereby incorporated herein by reference.
TECHNICAL FIELD
Aspects of this disclosure generally are related at least to medical systems including operative elongate members exhibiting non-uniform spacing therebetween in one or more expanded or deployed configurations, which, according to some embodiments, improves alignment or contact between at least a portion of at least one of the elongate members and one or more preferred regions of a tissue wall of a bodily cavity.
BACKGROUND
Cardiac surgery was initially undertaken using highly invasive open procedures.
A sternotomy, which is a type of incision in the center of the chest that separates the sternum was typically employed to allow access to the heart. In the past several decades, more and more cardiac operations are performed using intravascular or percutaneous techniques, where access to inner organs or other tissue is gained via a catheter.
Intravascular or percutaneous surgeries benefit patients by reducing surgery risk, complications and recovery time. However, the use of intravascular or percutaneous technologies also raises some particular challenges. Medical devices used in intravascular or percutaneous surgery need to be deployed via catheter systems which significantly increase the complexity of the device structure. As well, doctors do not have direct visual contact with the medical devices once the devices are positioned within the body.
One example of where intravascular or percutaneous medical techniques have been employed is in the treatment of a heart disorder called atrial fibrillation. Atrial fibrillation is a disorder in which spurious electrical signals cause an irregular heartbeat.
Atrial fibrillation has been treated with open heart methods using a technique known as the "Cox-Maze procedure".
During this procedure, physicians create specific patterns of lesions in the left and right atria to block various paths taken by the spurious electrical signals. Such lesions were originally created using incisions, but are now typically created by ablating the tissue with various techniques including radio-frequency (RF) energy, microwave energy, laser energy, electroporation and cryogenic techniques. The procedure is performed with a high success rate under the direct vision that is provided in open procedures, but is relatively complex to perform intravascularly or percutaneously because of the difficulty in creating the lesions in the correct locations. Various problems, potentially leading to severe adverse results, may occur if the lesions are placed incorrectly. It is particularly important to know the position of the various transducers that may include electrodes operable for creating the lesions relative to cardiac features such as the pulmonary veins and mitral valve. The continuity, transmurality and placement of the lesion patterns that are formed can impact the ability to block paths taken within the heart by spurious electrical signals. Accordingly, it can be critically important to ensure that the lesion patterns are properly formed and placed.
In this regard, the present inventors recognized that conventional devices exist that have relatively generic shapes that are not sufficiently tailored to place lesion-forming transducers in preferred locations within a bodily cavity, such as a heart, in order to produce a preferred lesion pattern. Accordingly, the present inventors recognized that there is a need for systems and techniques that ensure that lesions are properly formed and placed and that there is a need for systems and techniques that enhance positioning of various transducers relative to various anatomical structures within a bodily cavity.
SUMMARY
At least the above-discussed need is addressed and technical solutions are achieved by various embodiments of the present invention. In some embodiments, device systems and methods executed by such systems exhibit enhanced capabilities for placement of one or more transducers provided by one or more elongate members within one or more preferred regions of a tissue wall of a bodily cavity, and, in some embodiments, formation of one or more lesions in at least one of the one or more preferred regions.
In some embodiments, a medical system may be summarized as including a structure including a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially

2 through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity.
According to various embodiments, the structure includes a shaft member including a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end.
According to various embodiments, the shaft member includes a length from the proximal end to the distal end, the length of the shaft member sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity. According to various embodiments, each of the plurality of elongate members includes a first end, a second end, and a length from the first end to the second end. According to various embodiments, the structure may include a distal hub region and a proximal hub region when the structure is in the expanded configuration, the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration. The distal hub region is located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration according to various embodiments. According to various embodiments, each respective elongate member of the plurality of elongate members includes a mid-line-segment in the distal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the distal hub region, the width perpendicular to the length, in the distal hub region, of the respective elongate member or a tangent of the length, in the distal hub region, of the respective elongate member. According to various embodiments, when viewed from a direction normal to the distal hub region, the plurality of elongate members extend across one another in the distal hub region when the structure is in the expanded configuration, and, when viewed from the direction normal to the distal hub region, two of the mid-line-segments of two of the plurality of elongate members cross the mid-line-segment of a third of the plurality of elongate members at different locations when the structure is in the expanded configuration.
According to various embodiments, when viewed from the direction normal to the distal hub region, each of the two of the plurality of elongate members overlaps or is overlapped in the distal hub region by the third of the plurality of elongate members at each of the different locations when the structure is in the expanded configuration.

3 In some embodiments, the medical system may further include a plurality of electrodes coupled to at least some of the plurality of elongate members, the plurality of electrodes operable to be energized to interact with tissue within the bodily cavity.
In some embodiments, the width of each respective elongate member in the distal hub region is perpendicular to and longer than a thickness of the respective elongate member in the distal hub region.
In some embodiments, the two of the mid-line-segments of the two of the plurality of elongate members may cross each other at a location that, when viewed from the direction normal to the distal hub region, does not overlap and is not overlapped by any portion of at least the third of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration. In some embodiments, when viewed from the direction normal to the distal hub region, each of the different locations overlaps or is overlapped by a respective portion of each of two or more of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.
In some embodiments, when viewed from the direction normal to the distal hub region, a portion of each of the plurality of elongate members overlaps or is overlapped by a portion of at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.
In some embodiments, when viewed from the direction normal to the distal hub region, a portion of each of the plurality of elongate members overlaps or is overlapped by a portion of each of the others of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration. In some embodiments, when viewed from the direction normal to the distal hub region, a perimeter of the distal hub region may be defined, at least in part, from extremities of overlapping regions associated with the portion of each elongate member that overlaps or is overlapped by the portion of at least one other of the elongate members in the distal hub region when the structure is in the expanded configuration.
In some embodiments, when viewed from the direction normal to the distal hub region, a first one of the different locations overlaps or is overlapped by a first portion of a first one of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, and, when viewed from the direction normal to the distal hub region, a second one of the different locations does not overlap and is not overlapped by any portion of the

4 first one of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.
In some embodiments, when viewed from the direction normal to the distal hub region, a first one of the different locations overlaps or is overlapped by a first portion of a first one of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, and, when viewed from the direction normal to the distal hub region, a second one of the different locations overlaps or is overlapped by a respective portion of each of a group of at least two elongate members of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, the group of the at least two elongate members of the plurality of elongate members excluding the first one of the plurality of elongate members. In some embodiments, each respective portion of the group of the at least two elongate members of the plurality of elongate members is an outward-facing surface portion, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, the outward-facing surface portion of a first particular one of the group of the at least two elongate members of the plurality of elongate members and the outward-facing surface portion of a second particular one of the group of the at least two elongate members of the plurality of elongate members facing a same direction when the structure is in the expanded configuration, with the outward-facing surface portion of the first particular one crossing behind the outward-facing surface portion of the second particular one when the outward-facing surface portion of the second particular one is viewed from a direction opposite the same direction when the structure is in the expanded configuration.
In some embodiments, each of the plurality of elongate members includes a thickness, a front surface, and a back surface opposite across the thickness from the front surface, each front surface positionable to face away from an interior of the bodily cavity toward a tissue surface of a wall of the bodily cavity in a state in which the structure is positioned in the bodily cavity in the expanded configuration. According to some embodiments, portions of the third of the plurality of elongate members and each of the two of the plurality of elongate members at each of the different locations are arranged front surface-toward-back surface when the structure is in the expanded configuration.
In some embodiments, the medical system may further include a plurality of electrodes coupled to at least some of the plurality of elongate members, the plurality of

5 electrodes operable to be energized to interact with tissue within the bodily cavity. In some embodiments, a particular elongate member of the plurality of elongate members may include a central electrode of the plurality of electrodes located, at least in part, at a center of the distal hub region. According to some embodiments, the two of the mid-line-segments of the two of the plurality of elongate members may cross each other at a location in the distal hub region that, when viewed from the direction normal to the distal hub region, does not overlap and is not overlapped by any portion of the central electrode. In some embodiments, when viewed from the direction normal to the distal hub region, a first one of the different locations overlaps or is overlapped by a portion of a first one of the plurality of electrodes within the distal hub region when the structure is in the expanded configuration, and, when viewed from the direction normal to the distal hub region, a second one of the different locations does not overlap and is not overlapped by any portion of the first one of the plurality of electrodes in the distal hub region when the structure is in the expanded configuration. In some embodiments, when viewed from the direction normal to the distal hub region, a first one of the different locations overlaps or is overlapped by a first portion of a first one of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, and, when viewed from the direction normal to the distal hub region, a second one of the different locations overlaps or is overlapped by a respective portion of each of a group of at least two elongate members of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, the group of the at least two elongate members of the plurality of elongate members excluding the first one of the plurality of elongate members. In some embodiments, each respective portion of the group of the at least two elongate members of the plurality of elongate members is an outward-facing surface portion, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, the outward-facing surface portion of a first particular one of the group of the at least two elongate members of the plurality of elongate members and the outward-facing surface portion of a second particular one of the group of the at least two elongate members of the plurality of elongate members facing a same direction when the structure is in the expanded configuration, with the outward-facing surface portion of the first particular one crossing behind the outward-facing surface portion of the second particular one when the outward-facing surface portion of the second particular one is viewed from a direction opposite the same direction when the structure is

6 in the expanded configuration. In some embodiments, each of the group of the at least two elongate members of the plurality of elongate members includes an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward the interior of the structure when the structure is in the expanded configuration, and the outward-facing surface portion of the first particular one contacts the inward-facing surface portion of the second particular one when the structure is in the expanded configuration.
In some embodiments, when in the expanded configuration, the structure may encompass a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume. Each of the distal hub region and the proximal hub region may include 1/4 of the lines of latitude according to some embodiments.
In some embodiments, each of the plurality of elongate members includes a respective intermediate portion between the first end and the second end, each respective intermediate portion of each of the plurality of elongate members including a thickness, a front surface, and a back surface opposite across the thickness from the front surface. According to some embodiments, for each of the plurality of elongate members, the width in the distal hub region is perpendicular to and longer than the thickness in the distal hub region.
In some embodiments, each of a plurality of crossing points is defined as a location where edges of at least a pair of elongate members of the plurality of elongate members cross when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration. When the structure is in the expanded configuration, adjacent ones of the plurality of crossing points connected by respective line segments may form a boundary of the distal hub region according to various embodiments. In some embodiments, each crossing point is defined as a location that does not overlap and is not overlapped by any elongate member of the plurality of elongate members not comprised by the respective at least the pair of elongate members of the plurality of elongate members when the structure is in the expanded configuration. In some embodiments, the structure, when in the delivery configuration, arranges at least part of each respective elongate member of the plurality of elongate members to be advanced with the second end of the respective elongate member ahead of the first end of the respective elongate member toward the bodily cavity. According to various embodiments, the boundary abuts the distal hub region and the intermediate region.

7 In some embodiments, a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration. In some embodiments, each of the plurality of elongate members includes an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode is provided at least in part on the first side, the second side, or both the first side and the second side.
Various systems may include combinations and subsets of all the systems summarized above.
In some embodiments, a medical system may be summarized as including a structure including a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity.
According to various embodiments, the medical system may include a shaft member including a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end, and the shaft member comprising a length from the proximal end to the distal end. The length of the shaft member is sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity according to various embodiments. According to various embodiments, each of the plurality of elongate members includes a first end, a second end, and a length from the first end to the second end, each of the plurality of elongate members further including a respective intermediate portion positioned between the corresponding first and second ends, the respective intermediate portions of at least a first sub-group of the plurality of elongate members circumferentially arranged about an axis when the structure is in the expanded configuration. According to various embodiments, the structure includes a distal hub region and a proximal hub region when the structure is in the expanded configuration, the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration. According to various embodiments, the distal hub region is located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration. According to various embodiments, each respective elongate

8 member of the plurality of elongate members includes a mid-line-segment in the distal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the distal hub region, the width perpendicular to the length, in the distal hub region, of the respective elongate member or a tangent of the length, in the distal hub region, of the respective elongate member. According to various embodiments, when viewed from a direction normal to the distal hub region and when the structure is in the expanded configuration, (a) the mid-line-segments of the first sub-group of the plurality of elongate members cross each other at an on-axis location on the axis in the distal hub region, and (b) the mid-line-segments of a second sub-group of the plurality of elongate members cross each other at an off-axis location away from the axis in the distal hub region.
In some embodiments, when viewed from the direction normal to the distal hub region and when the structure is in the expanded configuration, the mid-line-segments of the second sub-group of the plurality of elongate members do not cross each other at any location on the axis in the distal hub region. In some embodiments, when viewed from a direction normal to the proximal hub region and when the structure is in the expanded configuration, mid-line-segments in the proximal hub region of the first sub-group of the plurality of elongate members cross each other at a first on-axis location on the axis in the proximal hub region. In some embodiments, when viewed from the direction normal to the proximal hub region and when the structure is in the expanded configuration, mid-line-segments in the proximal hub region of the second sub-group of the plurality of elongate members cross each other at a second on-axis location on the axis in the proximal hub region. In some embodiments, when viewed from a direction normal to the proximal hub region and when the structure is in the expanded configuration, mid-line-segments in the proximal hub region of the second sub-group of the plurality of elongate members cross each other at a particular on-axis location on the axis in the proximal hub region. In some embodiments, each of the plurality of elongate members includes a curved portion that intersects the axis at each of a respective at least two spaced apart locations along the axis when the structure is in the expanded configuration.
In some embodiments, the medical system may further include a plurality of electrodes coupled to at least some of the plurality of elongate members, the plurality of electrodes operable to be energized to interact with tissue within the bodily cavity. In some embodiments, the width of each respective elongate member in the distal hub region is

9 perpendicular to and longer than a thickness of the respective elongate member in the distal hub region. In some embodiments, when viewed from the direction normal to the distal hub region, the off-axis location does not overlap and is not overlapped by any portion of at least a first one of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, and when viewed from the direction normal to the distal hub region, the on-axis location overlaps or is overlapped by a portion of the first one of the plurality of elongate members when the structure is in the expanded configuration.
In some embodiments, the medical system may further include a plurality of electrodes coupled to at least some of the plurality of elongate members, the plurality of electrodes operable to be energized to interact with tissue within the bodily cavity. In some embodiments, a particular elongate member of the plurality of elongate members includes a first electrode of the plurality of electrodes located, at least in part, at a center of the distal hub region.
In some embodiments, when viewed from the direction normal to the distal hub region, the off-axis location does not overlap and is not overlapped by any portion of the first electrode, and, when viewed from the direction normal to the distal hub region, the on-axis location overlaps or is overlapped by a portion of the first electrode when the structure is in the expanded configuration. In some embodiments, the axis passes through the first electrode when the structure is in the expanded configuration.
In some embodiments, the structure may encompass a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume.
In some embodiments, each of the distal hub region and the proximal hub region may include 1/4 of the lines of latitude.
In some embodiments, each of the plurality of elongate members includes a respective intermediate portion between the first end and the second end, each respective intermediate portion of each of the plurality of elongate members including a thickness, a front surface, and a back surface opposite across the thickness from the front surface, and for each of the plurality of elongate members, the width is perpendicular to and longer than the thickness.
In some embodiments, the axis passes through a center of the distal hub region and a center of the proximal hub region when the structure is in the expanded configuration. In some embodiments, the axis is oblique with respect to an extension direction in which a length of the shaft member extends at the distal end of the shaft member. In some embodiments, the direction normal to the distal hub region is parallel to the axis.
In some embodiments, when viewed from the direction normal to the distal hub region, a portion of each of the plurality of elongate members overlaps or is overlapped by a portion of at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration. In some embodiments, when viewed from the direction normal to the distal hub region, a perimeter of the distal hub region is defined, at least in part, from extremities of overlapping regions associated with the portion of each of the plurality of elongate members that overlaps or is overlapped by the portion of the at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.
In some embodiments, each of the plurality of elongate members includes an outward-facing surface portion at least in the distal hub region, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, and each of the plurality of elongate members includes an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward the interior of the structure when the structure is in the expanded configuration. According to various embodiments, at least (i) the outward-facing surface portion of a first particular one of the first sub-group of the plurality of elongate members contacts the inward-facing surface portion of a second particular one of the first sub-group of the plurality of elongate members when the structure is in the expanded configuration, or (ii) the outward-facing surface portion of a first particular one of the second sub-group of the plurality of elongate members contacts the inward-facing surface portion of a second particular one of the second sub-group of the plurality of elongate members when the structure is in the expanded configuration.
In some embodiments, each of a plurality of crossing points is defined as a location where edges of at least a pair of elongate members of the plurality of elongate members cross when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration. According to some embodiments, when the structure is in the expanded configuration, adjacent ones of the plurality of crossing points connected by respective line segments form a boundary of the distal hub region. In some embodiments, each crossing point is defined as a location that does not overlap and is not overlapped by any elongate member of the plurality of elongate members not comprised by the respective at least the pair of elongate members of the plurality of elongate members when the structure is in the expanded configuration. In some embodiments, the structure, when in the delivery configuration, arranges at least part of each respective elongate member of the plurality of elongate members to be advanced with the second end of the respective elongate member ahead of the first end of the respective elongate member toward the bodily cavity. In some embodiments the boundary abuts the distal hub region and the intermediate region.
In some embodiments, a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration. In some embodiments, each of the plurality of elongate members includes an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode provided at least in part on the first side, the second side, or both the first side and the second side.
Various systems may include combinations and subsets of all the systems summarized above.
In some embodiments, a medical system may be summarized as including a structure including a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity.
According to various embodiments, the medical system includes a shaft member including a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end, and the shaft member including a length from the proximal end to the distal end. According to various embodiments, the length of the shaft member is sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity. According to various embodiments, each of the plurality of elongate members includes a first end, a second end, and a length from the first end to the second end.
According to various embodiments, the structure, when in the delivery configuration, arranges at least part of each respective elongate member of the plurality of elongate members to be advanced with the second end of the respective elongate member ahead of the first end of the respective elongate member toward the bodily cavity. According to various embodiments, the structure includes a distal hub region when the structure is in the expanded configuration, the plurality of elongate members converging at least in the distal hub region when the structure is in the expanded configuration, and the structure coupled to the shaft member at a region of the structure other than the distal hub region at least when the structure is in the expanded configuration. According to various embodiments, when viewed from a direction normal to the distal hub region, crossing portions of the plurality of elongate members extend across one another in the distal hub region when the structure is in the expanded configuration. According to various embodiments, each of a plurality of crossing points is defined as a location where edges of a respective at least two elongate members of the plurality of elongate members cross in the distal hub region when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration.
According to various embodiments, the plurality of crossing points, when adjacent ones thereof are connected by respective line segments, form a closed shape comprising at least one notch when viewed from a direction normal to the distal hub region when the structure is in the expanded configuration.
In some embodiments, each of the plurality of elongate members includes a respective portion radially spaced from an axis when the structure is in the expanded configuration, the respective portions of the plurality of elongate members circumferentially arranged about the axis when the structure is in the expanded configuration.
According to some embodiments, the structure includes a dimension transverse the axis, the dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration. In some embodiments, the structure includes a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration. According to various embodiments, the intermediate region includes a dimension transverse to an axis extending between a center of the distal hub region and a center of the proximal hub region, the dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration.

In some embodiments, neither the first end nor the second end of each elongate member of the plurality of elongate members resides in the distal hub region when the structure is in the expanded configuration. In some embodiments, the structure includes a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration. In some embodiments, at least the second end of each elongate member of the plurality of elongate members resides in the proximal hub region.
In some embodiments, the structure includes a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration. In some embodiments, the plurality of elongate members includes all elongate members that comprise electrodes and extend across one another in the distal hub region.
In some embodiments, when viewed from the direction normal to the distal hub region, a portion of each of the plurality of elongate members overlaps or is overlapped by a portion of at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration. In some embodiments, when viewed from the direction normal to the distal hub region, a perimeter of the distal hub region is defined, at least in part, from extremities of overlapping regions associated with the portion of each of the plurality of elongate members that overlaps or is overlapped by the portion of the at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.
In some embodiments, each location where edges of the respective at least two elongate members of the plurality of elongate members cross in the distal hub region when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration is a location that does not overlap and is not overlapped by any elongate member of the plurality of elongate members not comprised by the respective at least two elongate members of the plurality of elongate members when the structure is in the expanded configuration. In some embodiments, each of the plurality of crossing points is defined as a location where edges of two adjacent ones of the elongate members of the plurality of elongate members cross in the distal hub region when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration.
In some embodiments, each elongate member of the plurality of elongate members includes an outward-facing surface portion at least in the distal hub region, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, the outward-facing surface portion of a first particular elongate member of the plurality of elongate members and the outward-facing surface portion of a second particular elongate member of the plurality of elongate members facing a same direction when the structure is in the expanded configuration, with the outward-facing surface portion of the first particular elongate member crossing behind the outward-facing surface portion of the second particular elongate member when the outward-facing surface portion of the second particular member is viewed from a direction opposite the same direction when the structure is in the expanded configuration. In some embodiments, each elongate member of the plurality of elongate members includes an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward the interior of the structure when the structure is in the expanded configuration, and the outward-facing surface portion of the first particular elongate member contacts the inward-facing surface portion of the second particular elongate member when the structure is in the expanded configuration.
In some embodiments, the structure includes a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, and wherein, in the expanded configuration, the structure encompasses a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume, and wherein each of the distal hub region and the proximal hub region comprises 1/4 of the lines of latitude.
In some embodiments, each of the plurality of elongate members includes a respective intermediate portion between the first end and the second end, each respective intermediate portion of each of the plurality of elongate members including a width, a thickness, a front surface, and a back surface opposite across the thickness from the front surface, and for each of the plurality of elongate members, the width is perpendicular to and longer than the thickness. In some embodiments, when the structure is in the expanded configuration, the closed shape forms a boundary of the distal hub region. In some embodiments, a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration. In some embodiments, each of the plurality of elongate members includes an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode provided at least in part on the first side, the second side, or both the first side and the second side. In some embodiments, the at least one notch is a single notch.
Various systems may include combinations and subsets of all the systems summarized above.
In some embodiments, a medical system may be summarized as including a structure including a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity.
According to various embodiments, the medical system includes a shaft member including a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end, and the shaft member including a length from the proximal end to the distal end. According to various embodiments, the length of the shaft member is sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity. According to various embodiments, each of the plurality of elongate members includes a first end, a second end, and a length from the first end to the second end.
According to various embodiments, the structure includes a distal hub region when the structure is in the expanded configuration, the plurality of elongate members converging at least in the distal hub region when the structure is in the expanded configuration, and the structure coupled to the shaft member at a region of the structure other than the distal hub region at least when the structure is in the expanded configuration. According to various embodiments, when viewed from a direction normal to the distal hub region, a first pair of edges of a first pair of elongate members of the plurality of elongate members cross at a first location in the distal hub region when the structure is in the expanded configuration. According to various embodiments, when viewed from the direction normal to the distal hub region, a second pair of edges of the first pair of elongate members cross at a second location in the distal hub region when the structure is in the expanded configuration, the second pair of edges of the first pair of elongate members not including any edge of the first pair of edges of the first pair of elongate members.
According to various embodiments, when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration, the first location does not overlap, and is not overlapped by, a first elongate member of the plurality of elongate members while the second location overlaps, or is overlapped by, the first elongate member, the first elongate member not comprised by the first pair of elongate members.
In some embodiments, neither the first end nor the second end of each elongate member of the plurality of elongate members resides in the distal hub region when the structure is in the expanded configuration. In some embodiments, each of the plurality of elongate members is arranged to be percutaneously deliverable second end-first to the bodily cavity when the structure is in the delivery configuration, and the structure includes a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration. According to some embodiments, at least the second end of each elongate member of the plurality of elongate members resides in the proximal hub region. In some embodiments, each of the plurality of elongate members includes a respective portion radially spaced from an axis when the structure is in the expanded configuration, the respective portions of the plurality of elongate members circumferentially arranged about the axis when the structure is in the expanded configuration, and the structure includes a particular dimension transverse the axis, the particular dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration. In some embodiments, the structure includes a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intemiediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, and the intermediate region includes a particular dimension transverse to an axis extending between a center of the distal hub region and a center of the proximal hub, the particular dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration.
In some embodiments, the medical system further includes a plurality of electrodes coupled to at least some of the plurality of elongate members, the plurality of electrodes operable to be energized to interact with tissue within the bodily cavity, and when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration, the first location does not overlap, and is not overlapped by, a first electrode of the plurality of electrodes while the second location overlaps, or is overlapped by, the first electrode of the plurality of electrodes. In some embodiments, the plurality of elongate members includes all elongate members that include electrodes and extend across one another in the distal hub region.
In some embodiments, when viewed from the direction normal to the distal hub region, a portion of each of the plurality of elongate members overlaps or is overlapped by a portion of at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration. In some embodiments, when viewed from the direction normal to the distal hub region, a perimeter of the distal hub region is defined, at least in part, from extremities of overlapping regions associated with the portion of each of the plurality of elongate members that overlaps or is overlapped by the portion of the at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.
In some embodiments, when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration, the first location may be a location in the distal hub region that overlaps or is overlapped by a portion of a second elongate member of the plurality of elongate members, the second elongate member other than the first elongate member. In some embodiments, when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration, the second location may be a location in the distal hub region that overlaps or is overlapped by a portion of a third elongate member of the plurality of elongate members.
In some embodiments, each elongate member of the first pair of elongate members of the plurality of elongate members includes an outward-facing surface portion, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration. According to some embodiments, the outward-facing surface portions of the first pair of elongate members face a same first direction when the structure is in the expanded configuration, with the outward-facing surface portion of a first particular elongate member of the first pair of elongate members crossing behind the outward-facing surface portion of a second particular elongate member of the first pair of elongate members when the outward-facing surface portion of the second particular elongate member is viewed from a direction opposite the same first direction when the structure is in the expanded configuration.
In some embodiments, the structure includes a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration. According to some embodiments, in the expanded configuration, the structure may encompass a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume, and each of the distal hub region and the proximal hub region may include 1/4 of the lines of latitude.
In some embodiments, a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration. In some embodiments, each of the plurality of elongate members is arranged to be percutaneously deliverable second end-first to the bodily cavity when the structure is in the delivery configuration. In some embodiments, each of the plurality of elongate members includes an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode provided at least in part on the first side, the second side, or both the first side and the second side.
Various systems may include combinations and subsets of all the systems summarized above.
In some embodiments, a medical system may be summarized as including a structure including a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity.
According to various embodiments, the medical system includes a shaft member including a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end, and the shaft member including a length from the proximal end to the distal end. According to various embodiments, the length of the shaft member is sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity. According to various embodiments, each of the plurality of elongate members includes a first end, a second end, and a length from the first end to the second end.
According to various embodiments, the structure includes a distal hub region and a proximal hub region when the structure is in the expanded configuration, the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration. According to various embodiments, each of the plurality of elongate members includes an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode provided at least in part on the first side, the second side, or both the first side and the second side. According to various embodiments, a longitudinal axis of the shaft member extends through a center of a cross-section of the shaft member between the proximal and the distal ends of the shaft member. According to various embodiments, the plurality of elongate members meet at the distal hub region at least when the structure is in the expanded configuration. According to various embodiments, the plurality of elongate members meet at the proximal hub region at least when the structure is in the expanded configuration. According to various embodiments, an axis of the structure extends through a center of the distal hub region and a center of the proximal hub region when the structure is in the expanded configuration. According to various embodiments, at least when the structure is in the expanded configuration, a portion of the longitudinal axis extending outwardly from the distal end of the shaft member does not intersect the axis of the structure.
According to various embodiments, the portion of the longitudinal axis does not pass through at least the distal hub region at least when the structure is in the expanded configuration.
According to various embodiments, when the structure is in the expanded configuration, each respective elongate member of the plurality of elongate members includes a mid-line-segment in the distal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the distal hub region, the width perpendicular to the length, in the distal hub region, of the respective elongate member or a tangent of the length, in the distal hub region, of the respective elongate member. In some embodiments, when viewed along the axis of the structure, the mid-line-segments in the distal hub region of a first set of two of the plurality of elongate members cross each other at a first location in the distal hub region when the structure is in the expanded configuration, the first location intersected by the axis of the structure. In some embodiments, when the structure is in the expanded configuration, each respective elongate member of the plurality of elongate members includes a mid-line-segment in the proximal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the proximal hub region, the width perpendicular to the length, in the proximal hub region, of the respective elongate member or a tangent of the length, in the proximal hub region, of the respective elongate member. According to various embodiments, when viewed along the axis of the structure, the mid-line-segments in the proximal hub region of a second set of two of the plurality of elongate members cross each other at a second location in the proximal hub region when the structure is in the expanded configuration, the second location intersected by the axis of the structure. In some embodiments, the first set of two of the plurality of elongate members may include the second set of two of the plurality of elongate members.

In some embodiments, when the structure is in the expanded configuration, each respective elongate member of the plurality of elongate members includes a mid-line-segment in the proximal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the proximal hub region, the width perpendicular to the length, in the proximal hub region, of the respective elongate member or a tangent of the length, in the proximal hub region, of the respective elongate member.
According to various embodiments, when viewed along the axis of the structure, the mid-line-segments in the proximal hub region of a set of two of the plurality of elongate members cross each other at a particular location in the proximal hub region when the structure is in the expanded configuration. In some embodiments, the portion of the longitudinal axis does not pass though the particular location at least when the structure is in the expanded configuration.
In some embodiments, each of the plurality of elongate members includes a respective portion radially spaced from the axis of the structure when the structure is in the expanded configuration, the respective portions of the plurality of elongate members circumferentially arranged about the axis of the structure when the structure is in the expanded configuration. According to various embodiments, the structure includes a dimension transverse the axis of the structure, the dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration.
In some embodiments, the intermediate region may include a dimension transverse to the axis of the structure, the dimension varying in magnitude during a movement of the structure between the delivery configuration and the expanded configuration with the dimension having a peak in magnitude when the structure is in the expanded configuration. In some embodiments, neither the first end nor the second end of each elongate member of the plurality of elongate members resides in the distal hub region when the structure is in the expanded configuration. In some embodiments, at least the second end of each elongate member of the plurality of elongate members resides in the proximal hub region.
In some embodiments, when viewed along the axis of the structure, (i) each elongate member of the plurality of elongate members in the distal hub region is crossed by another elongate member of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, or (ii) each elongate member of the plurality of elongate members in the distal hub region crosses another elongate member of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration. In some embodiments, when viewed along the axis of the structure, (iii) each elongate member of the plurality of elongate members in the proximal hub region is crossed by another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration, or (iv) each elongate member of the plurality of elongate members in the proximal hub region crosses another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration.
In some embodiments, when viewed along the axis of the structure, (i) each elongate member of the plurality of elongate members in the proximal hub region is crossed by another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration, or (ii) each elongate member of the plurality of elongate members in the proximal hub region crosses another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration.
In some embodiments, when viewed along the axis of the structure, (i) each elongate member of the plurality of elongate members in the distal hub region is overlapped by another elongate member of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, or (ii) each elongate member of the plurality of elongate members in the distal hub region overlaps another elongate member of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration. In some embodiments, when viewed along the axis of the structure, (iii) each elongate member of the plurality of elongate members in the proximal hub region is overlapped by another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration, or (iv) each elongate member of the plurality of elongate members in the proximal hub region overlaps another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration.
In some embodiments, when viewed along the axis of the structure, a perimeter of the distal hub region is defined, at least in part, from extremities of overlapping regions associated with a portion of each elongate member that overlaps or is overlapped by a portion of at least one other of the elongate members in the distal hub region when the structure is in the expanded configuration.

In some embodiments, each elongate member of the plurality of elongate members includes an outward-facing surface portion at least in the distal hub region, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, the outward-facing surface portion of a first particular elongate member of the plurality of elongate members and the outward-facing surface portion of a second particular elongate member of the plurality of elongate members facing a same direction when the structure is in the expanded configuration, with the outward-facing surface portion of the first particular elongate member crossing behind the outward-facing surface portion of the second particular elongate member when the outward-facing surface portion of the second particular member is viewed from a direction opposite the same direction when the structure is in the expanded configuration. In some embodiments, each elongate member of the plurality of elongate members includes an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward the interior of the structure when the structure is in the expanded configuration, and the outward-facing surface portion of the first particular elongate member contacts the inward-facing surface portion of the second particular elongate member when the structure is in the expanded configuration.
In some embodiments, in the expanded configuration, the structure may encompass a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume. According to various embodiments, each of the distal hub region, and the proximal hub region includes 1/4 of the lines of latitude. In some embodiments, each of the plurality of elongate members includes a respective intermediate portion between the first end and the second end, each respective intermediate portion of each of the plurality of elongate members including a width, a thickness, a front surface, and a back surface opposite across the thickness from the front surface, and, for each of the plurality of elongate members, the width is perpendicular to and longer than the thickness. In some embodiments, a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration. In some embodiments, each of the plurality of elongate members is arranged to be percutaneously deliverable second end-first to the bodily cavity when the structure is in the delivery configuration.
Various systems may include combinations and subsets of all the systems summarized above.

In some embodiments, a medical system may be summarized as including a structure including a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity.
According to various embodiments, the medical system includes a shaft member including a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end, and the shaft member including a length from the proximal end to the distal end. According to various embodiments, the length of the shaft member is sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity. According to various embodiments, each of the plurality of elongate members includes a first end, a second end, and a length from the first end to the second end.
According to various embodiments, the structure includes a distal hub region and a proximal hub region when the structure is in the expanded configuration, the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration. According to various embodiments, each of the plurality of elongate members includes an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode provided at least in part on the first side, the second side, or both the first side and the second side. According to various embodiments, a longitudinal axis of the shaft member extends through a center of a cross-section of the shaft member between the proximal and the distal ends of the shaft member. According to various embodiments, each respective elongate member of the plurality of elongate members includes a mid-line-segment in the distal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the distal hub region, the width perpendicular to the length, in the distal hub region, of the respective elongate member or a tangent of the length, in the distal hub region, of the respective elongate member. According to various embodiments, each respective elongate member of the plurality of elongate members includes a mid-line-segment in the proximal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the proximal hub region, the width perpendicular to the length, in the proximal hub region, of the respective elongate member or a tangent of the length, in the proximal hub region, of the respective elongate member. According to various embodiments, an axis of the structure extends between a first location in the distal hub region and a second location in the proximal hub region when the structure is in the expanded configuration. According to various embodiments, when viewed along the axis of the structure, the mid-line-segments in the distal hub region of two of the plurality of elongate members cross each other at the first location in the distal hub region when the structure is in the expanded configuration.
According to various embodiments, when viewed along the axis of the structure, the mid-line-segments in the proximal hub region of the two of the plurality of elongate members cross each other at the second location in the proximal hub region when the structure is in the expanded configuration. According to various embodiments, at least when the structure is in the expanded configuration, a portion of the longitudinal axis extending outwardly from the distal end of the shaft member does not intersect the axis of the structure. According to various embodiments, the portion of the longitudinal axis does not pass through each of the first location and the second location when the structure is in the expanded configuration.
In some embodiments, each of the plurality of elongate members includes a respective portion radially spaced from the axis of the structure when the structure is in the expanded configuration, the respective portions of the plurality of elongate members circumferentially arranged about the axis of the structure when the structure is in the expanded configuration, and the structure includes a dimension transverse the axis of the structure, the dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration. In some embodiments, the intermediate region may include a dimension transverse to the axis of the structure, the dimension varying in magnitude during a movement of the structure between the delivery configuration and the expanded configuration with the dimension having a peak in magnitude when the structure is in the expanded configuration. In some embodiments, neither the first end nor the second end of each elongate member of the plurality of elongate members resides in the distal hub region when the structure is in the expanded configuration. In some embodiments, at least the second end of each elongate member of the plurality of elongate members resides in the proximal hub region.

In some embodiments, each elongate member of the plurality of elongate members includes an outward-facing surface portion at least in the distal hub region, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, the outward-facing surface portion of a first particular elongate member of the plurality of elongate members and the outward-facing surface portion of a second particular elongate member of the plurality of elongate members facing a same direction when the structure is in the expanded configuration, with the outward-facing surface portion of the first particular elongate member crossing behind the outward-facing surface portion of the second particular elongate member when the outward-facing surface portion of the second particular member is viewed from a direction opposite the same direction when the structure is in the expanded configuration. In some embodiments, each elongate member of the plurality of elongate members includes an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward the interior of the structure when the structure is in the expanded configuration, and the outward-facing surface portion of the first particular elongate member contacts the inward-facing surface portion of the second particular elongate member when the structure is in the expanded configuration.
In some embodiments, in the expanded configuration, the structure may encompass a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume. According to various embodiments, each of the distal hub region and the proximal hub region includes 1/4 of the lines of latitude. In some embodiments, a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration. In some embodiments, each of the plurality of elongate members is arranged to be percutaneously deliverable second end-first to the bodily cavity when the structure is in the delivery configuration.
In some embodiments, various systems may include combinations and subsets of the systems summarized above.

BRIEF DESCRIPTION OF THE DRAWINGS
It is to be understood that the attached drawings are for purposes of illustrating aspects of various embodiments and may include elements that are not to scale.
Figure 1 is a schematic representation of a medical device system according to various example embodiments, where the medical device system may include a data processing device system, an input-output device system, and a memory device system, according to some embodiments.
Figure 2A is a cutaway diagram of a heart showing an electrode-based device system percutaneously placed in a left atrium of the heart in one particular orientation according to various example embodiments, the electrode-based device system optionally being part of the input-output device system of Figure 1, according to some embodiments.
Figure 2B is a cutaway diagram of a heart showing the electrode-based device system of Figure 2A percutaneously placed in a left atrium of the heart in a different particular orientation according to various example embodiments.
Figure 3A is a partial schematic representation of a medical device system, which may represent one or more implementations of the medical device system of Figure 1 in which an expandable structure of an electrode-based device system is in a delivery or unexpanded configuration, according to various example embodiments.
Figure 3B is the representation of the medical device system of Figure 3A with the expandable structure shown in a deployed or expanded configuration, according to some embodiments.
Figure 3C is a plan view of the expandable structure of the medical device system of Figure 3A in a deployed or expanded configuration, according to some embodiments, the expandable structure including a distal hub region.
Figure 3D is the representation of the medical device system of Figure 3A with the expandable structure shown in a deployed or expanded configuration, according to some embodiments, with some elongate members of the structure sectioned for clarity.
Figure 3E is a plan view of a distal hemisphere of the expandable structure of the medical device system of Figure 3A in a deployed or expanded configuration, according to some embodiments, the expandable structure including a distal hub region.

Figures 3F, 3G, and 3H each include a partial schematic plan view of the expandable structure of the medical device system of Figure 3A in a deployed or expanded configuration, according to some embodiments, with various features omitted for clarity.
Figure 31 is the representation of the medical device system of Figure 3A with the expandable structure shown in a deployed or expanded configuration, according to some embodiments, with at least one elongate member of the structure sectioned for clarity.
Figure 3J is a plan view of a distal hemisphere of an expandable structure in a deployed or expanded configuration, the expandable structure including a distal hub region and a central electrode, according to some embodiments.
Figures 3K, 3L, and 3M each include a partial schematic plan view of a respective expandable structure in a deployed or expanded configuration, each respective expandable structure including elongate members arranged in different configurations, according to various embodiments.
Figure 4 is a schematic representation of an electrode-based device that includes a flexible circuit structure, according to various example embodiments.
Figure 5 is a plan view of a conventional expandable structure in a deployed or expanded configuration.
DETAILED DESCRIPTION
Some embodiments of the present invention pertain at least to medical systems or medical device systems including structures including elongate members exhibiting non-uniform spacing therebetween in one or more expanded or deployed configurations, which may improve alignment or contact at least between (a) one or more portions of the elongate members or one or more transducers or electrodes provided by one or more of the elongate members, and (b) one or more preferred or targeted regions of a tissue wall of a cavity of a bodily organ. In some embodiments, the non-unifolin spacing is configured to align with one or more anatomical features of the tissue wall and, in some embodiments, to produce a preferred lesion pattern in order to effectively treat the bodily organ. In some embodiments, such improved alignment or contact is beneficial in improving treatment of atrial fibrillation at least by providing more accurate placement and improved formation of ablated lesions in the tissue wall by the transducers or electrodes to block spurious electrical signals in the heart.

In the descriptions herein, certain specific details are set forth in order to provide a thorough understanding of various embodiments of the invention. However, one skilled in the art will understand that the invention may be practiced at a more general level without one or more of these details. In other instances, well-known structures have not been shown or described in detail to avoid unnecessarily obscuring descriptions of various embodiments of the invention.
Any reference throughout this specification to "one embodiment" or "an embodiment" or "an example embodiment" or "an illustrated embodiment" or "a particular embodiment" and the like means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, any appearance of the phrase "in one embodiment" or "in an embodiment" or "in an example embodiment" or "in this illustrated embodiment" or "in this particular embodiment" or the like in this specification is not necessarily all referring to one embodiment or a same embodiment.
Furthermore, the particular features, structures or characteristics of different embodiments may be combined in any suitable manner to form one or more other embodiments.
Unless otherwise explicitly noted or required by context, the word "or" is used in this disclosure in a non-exclusive sense. In addition, unless otherwise explicitly noted or required by context, the word "set" is intended to mean one or more. For example, unless otherwise explicitly noted or required by context, the phrase "a set of objects" means one or more of the objects. In addition, unless otherwise explicitly noted or required by context, the word "subset"
is intended to mean a set having the same or fewer elements of those present in the subset's parent or superset.
Further, the phrase "at least" is or may be used herein at times merely to emphasize the possibility that other elements may exist besides those explicitly listed. However, unless otherwise explicitly noted (such as by the use of the term "only") or required by context, non-usage herein of the phrase "at least" nonetheless includes the possibility that other elements may exist besides those explicitly listed. For example, the phrase 'based at least on A' includes A as well as the possibility of one or more other additional elements besides A. In the same manner, the phrase 'based on A' includes A, as well as the possibility of one or more other additional elements besides A. However, the phrase, 'based only on A' includes only A.
Similarly, the phrase 'configured at least to A' includes a configuration to perform A, as well as the possibility of one or more other additional actions besides A. In the same manner, the phrase 'configured to A' includes a configuration to perform A, as well as the possibility of one or more other additional actions besides A. However, the phrase 'configured only to A' means a configuration to perform only A.
The word "device", the word "machine", and the phrase "device system" all are intended to include one or more physical devices or sub-devices (e.g., pieces of equipment) that interact to perform one or more functions, regardless of whether such devices or sub-devices are located within a same housing or different housings. However, it may be explicitly specified that a device or machine or device system resides entirely within a same housing to exclude embodiments where the respective device, machine, or device system resides across different housings. The word "device" may equivalently be referred to as a "device system".
Further, the phrase "in response to" may be used in this disclosure. For example, this phrase might be used in the following context, where an event A occurs in response to the occurrence of an event B. In this regard, such phrase includes, for example, that at least the occurrence of the event B causes or triggers the event A.
In some embodiments, the term "adjacent", the term "proximate", or the like refers at least to a sufficient closeness between the objects defined as adjacent, proximate, or the like, to allow the objects to interact in a designated way. For example, if object A
perfolms an action on an adjacent or proximate object B, objects A and B would have at least a sufficient closeness to allow object A to perform the action on object B. In this regard, some actions may require contact between the associated objects, such that if object A performs such an action on an adjacent or proximate object B, objects A and B would be in contact, for example, in some instances or embodiments where object A needs to be in contact with object B
to successfully perform the action. In some embodiments, the term "adjacent", the tetni "proximate", or the like additionally or alternatively refers to objects that do not have another substantially similar object between them. For example, object A and object B could be considered adjacent or proximate if they contact each other (and, thus, it could be considered that no other object is between them), or if they do not contact each other but no other object that is substantially similar to object A, object B, or both objects A and B, depending on the embodiment, is between them. In some embodiments, the term "adjacent", the term "proximate", or the like additionally or alternatively refers to at least a sufficient closeness between the objects defined as adjacent, proximate, or the like, the sufficient closeness being within a range that does not place any one or more of the objects into a different or dissimilar region, or does not change an intended function of any one or more of the objects or of an encompassing object that includes a set of the objects. Different embodiments of the present invention adopt different ones or combinations of the above definitions. Of course, however, the term "adjacent", the term "proximate", or the like is not limited to any of the above example definitions, according to some embodiments. In addition, the teini "adjacent" and the term "proximate" do not have the same definition, according to some embodiments.
The word "fluid" as used in this disclosure should be understood to include any fluid that can be contained within a bodily cavity or can flow into or out of, or both into and out of a bodily cavity via one or more bodily openings positioned in fluid communication with the bodily cavity. In some embodiments, the word "fluid" may include fluid that is not inherent to the bodily cavity, such as saline or other fluid that might be artificially introduced into the bodily cavity. In some embodiments, the word "fluid" may include a fluid that may be artificially introduced into the bodily cavity without the fluid coming into direct contact with tissue or a naturally occurring bodily fluid (e.g., a fluid employed in various cryogenic ablation procedures).
In the case of cardiac applications, fluid such as blood will flow into and out of various intra-cardiac cavities (e.g., a left atrium or right atrium).
The phrase "bodily opening" as used in this disclosure should be understood to include a naturally occurring bodily opening or channel or lumen; a bodily opening or channel or lumen formed by an instrument or tool using techniques that may include, but are not limited to, mechanical, thermal, electrical, chemical, and exposure or illumination techniques; a bodily opening or channel or lumen formed by trauma to a body; or various combinations of one or more of the above or other bodily openings. Various elements having respective openings, lumens or channels and positioned within the bodily opening (e.g., a catheter sheath) may be present in various embodiments. These elements may provide a passageway through a bodily opening for various devices employed in various embodiments.
The words "bodily cavity" as used in this disclosure should be understood to mean a cavity in a body. The bodily cavity may be a cavity provided in a bodily organ (e.g., an intra-cardiac cavity or chamber of a heart). A bodily opening may be provided as a passageway to a bodily cavity in some embodiments.

The word "tissue" may be used in this disclosure, and tissue may include non-fluidic tissue and fluidic tissue. Non-fluidic tissue generally (or predominantly) has solid-like properties, such as tissue that forms a surface of a body or a surface within a bodily cavity, a surface of an anatomical feature or a surface of a feature associated with a bodily opening positioned in fluid communication with the bodily cavity. Non-fluidic tissue may include part or all of a tissue wall or membrane that defines a surface of the bodily cavity.
In this regard, the tissue may form an interior surface of the cavity that at least partially surrounds a fluid within the cavity. In the case of cardiac applications, non-fluidic tissue may include tissue used to form an interior surface of an intra-cardiac cavity such as a left atrium or right atrium. Fluidic tissue, on the other hand, generally (or predominantly) has fluid-like properties (as compared to solid-like properties). An example of fluidic tissue is blood. In this regard, it should be noted that fluidic tissue may have some solid-like component(s) (e.g., fluidic tissue may include solid-like components), and non-fluidic tissue may have some fluid-like component(s) (e.g., non-fluidic tissue may include fluidic tissue within it). Unless otherwise explicitly noted or required by context, the word "tissue" should include non-fluidic tissue and fluidic tissue. However, some contexts where the word "tissue" would not include fluidic tissue are when tissue ablation is discussed, and ablation of fluidic tissue could be undesired, as discussed below. In various embodiments, non-fluidic tissue does not include excised tissue.
The word "ablation" as used in this disclosure should be understood to include any disruption to certain properties of tissue. Most commonly, the disruption is to the electrical conductivity of tissue and may be achieved by heating, which may be generated with resistive or radio-frequency (RF) techniques for example. Other properties of tissue, such as mechanical or chemical, and other means of disruption, such as optical, are included when the term "ablation" is used. In some embodiments, electroporation techniques are included when the term "ablation" is used. In some embodiments, ablative power levels may be within the range of 3 W to 5 W (as compared, e.g., to a non-tissue-ablative power level range of 50 mW to 60 mW
that may be used for typical impedance determinations). In some embodiments, ratios of employed ablative power levels to employed non-tissue-ablative power levels (e.g., used for typical impedance determinations) may be: at least equal or greater than 50:1 in various embodiments; at least greater than 60:1 in some embodiments; at least greater than 80:1 in other various embodiments;
and at least greater than 100:1 in yet other embodiments. In some embodiments, systems are configured to perform ablation of non-fluidic tissue while avoiding the delivery of excessive energy to fluidic tissue, because energy that is sufficient to ablate non-fluidic tissue may also impact fluidic tissue in some circumstances. For example, energy that is sufficient to ablate non-fluidic tissue, in some circumstances, may cause blood (an example of fluidic tissue) to coagulate. In these and other embodiments where ablative energy transferred to fluidic tissue is not desired, it should be understood that any statement or reference to the 'ablation of tissue' or the like in these contexts is intended to refer to ablation of non-fluidic tissue, as opposed to ablation of fluidic tissue.
The term "transducer" as used in this disclosure should be interpreted broadly as any device capable at least of distinguishing between fluid and non-fluidic tissue, sensing temperature, creating heat, ablating tissue and measuring electrical activity of a tissue surface, stimulating tissue or any combination thereof. A transducer may convert input energy of one fowl into output energy of another form. Without limitation, a transducer may include an electrode, and references to a "transducer" herein may be replaced with "electrode" according to some embodiments. Without limitation, a transducer may include an electrode or a sensing device, or both an electrode and a sensing device. An electrode, in some embodiments, may be configured at least as a sensing device. Because a transducer may include an electrode according to various embodiments, any reference herein to a transducer may also imply a reference to an electrode, or vice versa. A transducer may be constructed from several parts, which may be discrete components or may be integrally formed.
Figure 1 schematically illustrates a medical device system 100 according to some embodiments. In some embodiments, the medical device system 100 includes a data processing device system 110, an input-output device system 120, and a processor-accessible memory device system 130. The processor-accessible memory device system 130 and the input-output device system 120 are communicatively connected to the data processing device system 110.
The data processing device system 110 includes one or more data processing devices that implement or execute, in conjunction with other devices, such as those in the system 100, methods of various embodiments that may be employed by various aspects described in this disclosure. Each of the phrases "data processing device", "data processor", "processor", and "computer" and the like is intended to include any data processing device, such as a central processing unit ("CPU"), a desktop computer, a laptop computer, a mainframe computer, a tablet computer such as an iPad (Trademark Apple Inc., Cupertino California), a personal digital assistant, a cellular phone, a smartphone, or any other device for processing data, managing data, or handling data, whether implemented with electrical, magnetic, optical, biological components, or otherwise.
The memory device system 130 includes one or more processor-accessible memory devices configured to store information, including the information needed to execute the methods associated with various embodiments. The memory device system 130 may be a distributed processor-accessible memory device system including multiple processor-accessible memory devices communicatively connected to the data processing device system 110 via a plurality of computers and/or devices. On the other hand, the memory device system 130 need not be a distributed processor-accessible memory system and, consequently, may include one or more processor-accessible memory devices located within a single data processing device.
Each of the phrases "processor-accessible memory" and "processor-accessible memory device" and the like is intended to include any processor-accessible data storage device, whether volatile or nonvolatile, electronic, magnetic, optical, or otherwise, including but not limited to, registers, floppy disks, hard disks, Compact Discs, DVDs, flash memories, ROMs, and RAMs. In some embodiments, each of the phrases "processor-accessible memory"
and "processor-accessible memory device" is intended to include or be a processor-accessible (or computer-readable) data storage medium. In some embodiments, each of the phrases "processor-accessible memory" and "processor-accessible memory device" is intended to include or be a non-transitory processor-accessible (or computer-readable) data storage medium. In some embodiments, the memory device system 130 may be considered to include or be a non-transitory processor-accessible (or computer-readable) data storage medium system. And, in some embodiments, the memory device system 130 may be considered to include or be a non-transitory processor-accessible (or computer-readable) storage medium system.
The phrase "communicatively connected" is intended to include any type of connection, whether wired or wireless, between devices, data processors, or programs in which data may be communicated. Further, the phrase "communicatively connected" is intended to include a connection between devices or programs within a single data processor, a connection between devices or programs located in different data processors, and a connection between devices not located in data processors at all. In this regard, although the memory device system 130 is shown separately from the data processing device system 110 and the input-output device system 120, one skilled in the art will appreciate that the memory device system 130 may be located completely or partially within the data processing device system 110 or the input-output device system 120. Further in this regard, although the input-output device system 120 is shown separately from the data processing device system 110 and the memory device system 130, one skilled in the art will appreciate that such system may be located completely or partially within the data processing system 110 or the memory device system 130, depending upon the contents of the input-output device system 120. Further still, the data processing device system 110, the input-output device system 120, and the memory device system 130 may be located entirely within the same device or housing or may be separately located, but communicatively connected, among different devices or housings. In the case where the data processing device system 110, the input-output device system 120, and the memory device system 130 are located within the same device, the system 100 of Figure 1 may be implemented by a single application-specific integrated circuit (ASIC) in some embodiments.
The input-output device system 120 may include a mouse, a keyboard, a touch screen, another computer, or any device or combination of devices from which a desired selection, desired information, instructions, or any other data is input to the data processing device system 110. The input-output device system 120 may include a user-activatable control system that is responsive to a user action, such as actions from a care provider such as a physician or technician. The input-output device system 120 may include any suitable interface for receiving information, instructions or any data from other devices and systems described in various ones of the embodiments. In this regard, the input-output device system 120 may include various ones of other systems described in various embodiments. For example, the input-output device system 120 may include at least a portion of a medical system, transducer-based device system, or an electrode-based device system described herein. The phrase "transducer-based device system" is intended to include one or more physical devices or systems that include various transducers. Similarly, the phrase "electrode-based device system" is intended to include one or more physical devices or systems that include various electrodes. In this regard, the phrases "transducer-based device system" and "electrode-based device system"
may be used interchangeably in accordance with various embodiments. Similarly, the phrases "transducer-based device" and "electrode-based device" may be used interchangeably in accordance with various embodiments.
The input-output device system 120 also may include an image generating device system, a display device system, a speaker device system, a processor-accessible memory device system, or any device or combination of devices to which information, instructions, or any other data is output from the data processing device system 110. In this regard, if the input-output device system 120 includes a processor-accessible memory device, such memory device may or may not foul' part or all of the memory device system 130. The input-output device system 120 may include any suitable interface for outputting information, instructions or data to other devices and systems described in various ones of the embodiments. In this regard, the input-output device system may include various other devices or systems described in various embodiments.
Figure 2A shows an electrode-based device system 300, which may be all or part of a medical system or medical device system, and which may be included in the input-output device system 120 of Figure 1, according to some embodiments. Because, as described in more detail below with respect to Figure 4, electrodes may be part of transducers, according to some embodiments, the system 300 may also be considered a transducer-based device system in some embodiments.
Such a system 300 may be beneficial for, among other things, investigating or treating a bodily organ, for example, a heart 202, according to some example embodiments. The electrode-based device system 300 may include a structure or frame 308 that may be percutaneously or intravascularly inserted into a portion of the heart 202, such as an intra-cardiac cavity like left atrium 204. In this example, the electrode-based device system 300 includes a catheter 314 inserted via the inferior vena cava 208 and penetrating through a bodily opening in transatrial septum 210 from right atrium 212. In other embodiments, other paths may be taken.
Catheter 314 may include an elongated flexible rod or shaft member 316 appropriately sized to be deliverable percutaneously or intravascularly. The shaft member 316 may include a proximal end 316a (not shown in Figure 2A, but shown, for example, in Figure 3A, which is shown in a region where the shaft member 316 is cut-away so that an interior of the shaft member 316 may be illustrated). The shaft member 316 may also include a distal end 316b, with the structure 308 coupled to the shaft member 316 at least proximate the distal end 316b, and the shaft member 316 including a length from the proximal end 316a to the distal end 316b, the length of the shaft member 316 sufficient to position the proximal end 316a outside a body comprising the bodily cavity during a state in which the structure 308 is positioned in the bodily cavity.
Various portions of catheter 314 may be steerable. Catheter 314 may include one or more lumens (not shown). The lumen(s) may carry one or more communications or power paths, or both. For example, the lumens(s) may carry one or more electrical conductors or control leads 317 (two shown in Figure 2A). Electrical conductors 317 provide electrical connections for system 300 that are accessible externally from a patient in which the electrode-based device system 300 is inserted, according to some embodiments.
In some embodiments, the electrical conductors 317 may provide electrical connections to transducers 306 (three called out in Figure 2A) that respectively include one or more electrodes, and optionally one or more other devices, (e.g., both discussed with respect to Figure 4, below) configured to, among other things, provide stimulation (e.g., electrical stimulation that may include pinging or pacing) to tissue within a bodily cavity (e.g., left atrium 204), ablate tissue in a desired pattern within the bodily cavity, sense characteristics of tissue (e.g., electrophysiological activity, convective cooling, permittivity, force, temperature, impedance, thickness, or a combination thereof) within the bodily cavity, or a combination thereof or sense various other animate or non-animate physical characteristics.
The sensing of characteristics may, among other things, be configured to distinguish between fluid, such as fluidic tissue (e.g., blood), and non-fluidic tissue forming an interior surface of a bodily cavity (e.g., left atrium 204); may be configured to map the cavity, for example, using positions of openings or ports into and out of the cavity to determine a position or orientation (e.g., pose), or both of a portion of the device system 300 in the bodily cavity; may be configured to indicate whether an ablation has been successful; or a combination thereof.
Electrode-based device system 300 may include a frame or structure 308 which assumes an unexpanded or delivery configuration (e.g., Figure 3A, discussed below) for delivery to left atrium 204. Structure 308 is deployed or expanded (i.e., shown in a deployed or expanded configuration in Figure 2A, as well as at least Figures 2B, 3B, 3C, 3D, 3E, 3F, 3G, 31-1, 31, 3J, 3K, 3L, and 3M, which are discussed below) upon delivery to left atrium 204.
In this regard, in some embodiments, the electrode-based device system 300 is moveable between a delivery or unexpanded configuration (e.g., Figure 3A, discussed below) in which a portion (e.g., the structure 308) of the device system 300 is sized for passage through a bodily opening leading to a bodily cavity, and a deployed or expanded configuration (e.g., Figure 2A, as well as at least Figure 3B discussed below) in which the portion of the device system 300 has a size too large for passage through the bodily opening leading to the bodily cavity. An example of an expanded or deployed configuration is when the portion of the electrode-based device system is in its intended-deployed-operational state inside the bodily cavity. Another example of the expanded or deployed configuration is when the portion of the electrode-based device system 300 is being changed from the delivery configuration to the intended-deployed-operational state to a point where the portion of the device system now has a size too large for passage through the bodily opening leading to the bodily cavity. In some embodiments, the portion of the electrode-based device system 300 has a size or dimension when the structure 308 is in the expanded or deployed configuration that is larger than the corresponding size or dimension of the portion of the electrode-based device system 300 in the delivery configuration. Further, in some embodiments, when the portion (e.g., the structure 308) is in the expanded or deployed configuration in the left atrium 204, various ones of a plurality of transducers 306 are positioned proximate the interior surface formed by non-fluidic tissue 222 of left atrium 204. In some embodiments, when the portion (e.g., the structure 308) is in the expanded or deployed configuration in the left atrium 204, various ones of plurality of transducers 306 are positioned such that a physical portion of each of the various ones of the transducers 306 is configured to contact the interior surface formed by non-fluidic tissue 222 of left atrium 204. In some embodiments, at least some of the transducers 306 are configured to sense a physical characteristic of a fluid (i.e., blood), non-fluidic tissue 222 (i.e., cardiac wall tissue), or both, that may be used to determine a position or orientation (i.e., pose), or both, of a portion of a device system 300 within, or with respect to left atrium 204. For example, transducers 306 may be configured to determine a location of pulmonary vein ostia (not shown) or a mitral valve 226, or both. In some embodiments, at least some of the transducers 306 may be controlled to selectively ablate portions of the non-fluidic tissue 222. For example, some of the transducers 306 may be controlled to ablate a pattern or path around various ones of the bodily openings, ports or pulmonary vein ostia, for instance, to reduce or eliminate the occurrence of atrial fibrillation. Each of various ones of the transducers 306 may include an electrode in various embodiments, as described below with respect to Figure 4, for example.
Each of Figures 3A, 3B, and 3C is a partial schematic representation of a medical device system, which may represent one or more implementations of the medical device system 100 of Figure 1, according to some embodiments. The medical system of each of these figures may include the electrode-based device system 300, which itself may include several hundred transducers 306 or electrodes 315 (only a few called out in the figures), but need not include that many. Figure 3A illustrates the electrode-based device system 300 in the delivery or unexpanded configuration, according to various example embodiments, and Figure 3B
illustrates the electrode-based device system 300 in the deployed or expanded configuration, according to some embodiments.
In this regard, the electrode-based device system 300 may include a plurality of elongate members 304 (only a few called out in the figures) and a plurality of transducers 306 or electrodes 315 (only a few called out in the figures). In some embodiments, the transducers 306 or electrodes 315 have the configuration of the transducers 306 or electrodes 315 in Figure 2A.
In some embodiments, the transducers 306 or electrodes 315 are formed as part of, coupled to, or are located on, at least some of the elongate members 304. In some embodiments, the transducers 306 or electrodes 315 are operable to be energized (e.g., via an energy source device system 340, discussed below) to interact with tissue within the bodily cavity.
In some embodiments, the elongate members 304 are arranged as, or form at least part of, the frame or structure 308 that is selectively moveable between an unexpanded or delivery configuration (e.g., as shown in Figure 3A) and an expanded or deployed configuration (e.g., as shown in Figure 3B) that may be used to position elongate members 304 against a tissue surface within the bodily cavity or position the elongate members 304 at least proximate to, or in contact with, the tissue surface.
In some embodiments, the structure 308 has a size in the unexpanded or delivery configuration suitable for percutaneous delivery at least partially through a bodily opening (e.g., via catheter sheath 312, not shown in Figure 3B) to the bodily cavity. In some embodiments, structure 308 has a size when the structure 308 is in the expanded or deployed configuration too large for percutaneous delivery through a bodily opening (e.g., via catheter sheath 312) to the bodily cavity. The elongate members 304 may form part of a flexible circuit structure (i.e., also known as a flexible printed circuit board (PCB) circuit). The elongate members 304 may include a plurality of different material layers. Each of the elongate members 304 may include a plurality of different material layers. The structure 308 may include a shape memory material, for instance Nitinol. The structure 308 may include a metallic material, for instance stainless steel, or non-metallic material, for instance polyimide, or the structure 308 may include both a metallic and a non-metallic material by way of non-limiting example. The incorporation of a specific material into structure 308 may be motivated by various factors including the specific requirements of each of the unexpanded or delivery configuration and expanded or deployed configuration, the required position or orientation (i.e., pose) or both of structure 308 in the bodily cavity, or the requirements for successful ablation of a desired pattern. For clarity, not all of the elongate members shown in the deployed or expanded configuration shown in Figure 3B are shown in the structure 308 in the delivery configuration shown in Figure 3A.
The plurality of transducers 306 is positionable within a bodily cavity, for example, by positioning of the structure 308. For instance, in some embodiments, the transducers 306 are able to be positioned in a bodily cavity by movement into, within, or into and within the bodily cavity, with or without a change in a configuration of the plurality of transducers 306 (e.g., a change in a configuration of the structure 308 causes a change in configuration of the transducers 306 in some embodiments). In some embodiments, the plurality of transducers 306 is arrangeable to form a two- or three-dimensional distribution, grid or array capable of mapping, ablating or stimulating or otherwise interacting with an inside surface of a bodily cavity or lumen without requiring mechanical scanning.
As shown for example in Figure 3A, the plurality of transducers 306 is arranged in a distribution receivable in a bodily cavity (not shown in Figure 3A). As shown for example, in Figure 3A, the plurality of transducers 306 is arranged in a distribution suitable for delivery to a bodily cavity, according to some embodiments. Also as shown for example in Figure 3A, the structure 308, when in the delivery configuration, arranges at least part of each respective elongate member of the plurality of elongate members 304 to be advanced with a distal end (also referred to as the second end) 305 of the respective elongate member 304 ahead of a proximal end (also referred to as the first end) 307 of the respective elongate member 304 toward the bodily cavity, according to some embodiments. In some embodiments, as shown for example in Figure 3A, each of the plurality of elongate members 304 is arranged to be percutaneously deliverable distal end first to the bodily cavity when the structure is in the delivery configuration.
Figure 4 is a schematic side elevation view of at least a portion of an electrode-based device system 400 that includes a flexible circuit structure 401 that is employed to provide a plurality of transducers 406 (two called out) according to various example embodiments. The electrode-based device system 400 may form part of each of one or more or all elongate members 304, according to some embodiments. In some embodiments, the transducers 406 correspond to the transducers 306. In some embodiments, the flexible circuit structure 401 may form part of a structure (e.g., structure 308) that is selectively moveable between a delivery configuration sized for percutaneous delivery and an expanded or deployed configuration sized too large for percutaneous delivery. In some embodiments, the flexible circuit structure 401 may be located on, or form at least part of, a structural component (e.g., elongate member 304) of an electrode-based device system (e.g., electrode-based device system 300).
The flexible circuit structure 401 may be formed by various techniques including flexible printed circuit techniques. In some embodiments, the flexible circuit structure 401 includes various layers including flexible layers 403 (three called out in Figure 4 as reference symbols 403a, 403b, and 403c). In some embodiments, each of the flexible layers 403 includes an electrical insulator material (e.g., polyimide). One or more of the flexible layers 403 may include a different material than another of the flexible layers 403. In some embodiments, the flexible circuit structure 401 includes various electrically conductive layers 404 (three called out in Figure 4 as reference symbols 404a, 404b, and 404c). The electrically conductive layers 404 may be interleaved with the flexible layers 403. In some embodiments, each of the electrically conductive layers 404 is patterned to form various electrically conductive elements. For example, electrically conductive layer 404a may be patterned to form a respective electrode 415 included as part of each of the transducers 406. Electrodes 415 may have respective electrode edges 415-1 that form a periphery of an electrically conductive surface or surface portion associated with the respective electrode 415.
In some embodiments, the respective electrically conductive surface or surface portion of one or more of the electrodes 415 (or 315) is configured to transmit energy to contacting tissue at a level sufficient for ablation of the tissue. Other energy levels may be transmitted to, for example, provide stimulation (e.g., electrical stimulation that may include pinging or pacing) to tissue within a bodily cavity (e.g., left atrium 204), sense characteristics of tissue (e.g., electrophysiological activity, convective cooling, permittivity, force, temperature, impedance, thickness, or a combination thereof) within the bodily cavity, or a combination thereof.
Electrically conductive layer 404b is patterned, in some embodiments, to form respective temperature sensors 408 for each of the transducers 406 as well as various leads 410a arranged to provide electrical energy to the temperature sensors 408. In some embodiments, each temperature sensor 408 includes a patterned resistive member 409 (two called out as 409a and 409b) having a predetermined electrical resistance. In some embodiments, each resistive member 409 includes a metal having relatively high electrical conductivity characteristics (e.g., copper).
In some embodiments, electrically conductive layer 404c is patterned to provide portions of various leads 410b arranged to provide an electrical communication path to electrodes 415. In some embodiments, leads 410b are arranged to pass though vias (not shown) in flexible layers 403a and 403b to connect with electrodes 415. Although Figure 4 shows flexible layer 403c as being a bottom-most layer, some embodiments may include one or more additional layers underneath flexible layer 403c, such as one or more structural layers, such as a stainless steel or composite layer. These one or more structural layers, in some embodiments, are part of the flexible circuit structure 401 and may be part of, e.g., elongate member 304.
In addition, although Figure 4 shows only three flexible layers 403a-403c and only three electrically conductive layers 404a-404c, it should be noted that other numbers of flexible layers, other numbers of electrically conductive layers, or both, may be included.
In some embodiments, electrodes 415 are employed to selectively deliver RF
energy to various tissue structures within a bodily cavity (not shown) (e.g., a tissue cavity such as an intra-cardiac cavity). The energy delivered to the tissue structures may be sufficient for ablating portions of the tissue structures. In various embodiments, the tissue structures are typically founed from non-fluidic tissue and the energy sufficient for ablating portions of the tissue structures is typically referred to as sufficient for tissue ablation.
It is noted that energy sufficient for non-fluidic-tissue ablation may include energy levels sufficient to disrupt or alter fluidic tissue (e.g., blood) that may, for example, be located proximate the tissue structure. In many cases, the application of non-fluidic-tissue-ablative energy (i.e., energy that is sufficient to ablate non-fluidic tissue) to fluidic tissue, such as blood, is undesired when the energy is sufficient to disrupt or adversely impact a property of the fluidic tissue.
For example, the application of non-fluidic-tissue-ablative energy to blood may be undesired when the energy is sufficient to cause various parts of the blood to coagulate in a process typically referred to as thermal coagulation. In this regard, some embodiments facilitate detection of conditions where an electrode configured to deliver non-fluidic-tissue-ablative energy may be in a configuration where it is not able to properly transmit such energy. In some embodiments, a detection of such a condition results in an error notification being transmitted or otherwise presented to a user or, in some embodiments, a restriction of that electrode from transmitting at least a portion of the non-fluidic-tissue-ablative energy. In some embodiments, a detection of such a condition results in an error notification being transmitted or otherwise presented to a user or, in some embodiments, a restriction of that electrode from being selected by a user action (e.g., a user selection of that electrode from a number of selectable electrodes to perform a particular function, such as transmitting at least a portion of the non-fluidic-tissue-ablative energy).
The energy delivered to the tissue may be delivered to cause monopolar tissue ablation, bipolar tissue ablation, or blended monopolar-bipolar tissue ablation by way of non-limiting example. In some embodiments, each electrode 415 is employed to sense an electrical potential in the tissue proximate the electrode 415. In some embodiments, each electrode 415 is employed in the generation of an intra-cardiac electrogram. In some embodiments, each resistive member 409 is positioned adjacent a respective one of the electrodes 415. In some embodiments, each of the resistive members 409 is positioned in a stacked or layered array with a respective one of the electrodes 415 to form a respective one of the transducers 406. In some embodiments, the resistive members 409 are connected in series to allow electrical current to pass through all of the resistive members 409. In some embodiments, leads 410a are arranged to allow for a sampling of electrical voltage across each resistive members 409. This arrangement allows for the electrical resistance of each resistive member 409 to be accurately determined. The ability to accurately determine the electrical resistance of each resistive member 409 may be motivated by various reasons including determining temperature values at locations at least proximate the resistive member 409 based at least on changes in the resistance caused by convective cooling effects (e.g., as provided by blood flow). In various embodiments, some of the transducers 406 are controlled to provide one or more electrical signals to tissue (e.g., non-fluidic tissue associated with a tissue wall or fluidic tissue such as blood) and information or a derivative thereof is determined in response to the provided signals, the information or the derivative thereof indicating a result of an interaction between the one or more signals and the tissue. In various ones of these embodiments, the one or more signals may include one or more energy levels insufficient for tissue ablation.
In some embodiments in which the electrode-based device system 300 is deployed in a bodily cavity (e.g., when the electrode-based device system 300 takes the form of a catheter device system arranged to be percutaneously or intravascularly delivered to a bodily cavity), it may be desirable to perfoon various mapping procedures in the bodily cavity.
For example, when the bodily cavity is an intra-cardiac cavity, a desired mapping procedure may include mapping electrophysiological activity in the intra-cardiac cavity. Other desired mapping procedures may include mapping of various anatomical features within a bodily cavity. An example of the mapping performed by devices according to various embodiments may include locating the position of the ports of various bodily openings positioned in fluid communication with a bodily cavity. For example, in some embodiments, it may be desired to determine the locations of various ones of the pulmonary veins or the mitral valve that each interrupts an interior surface of an intra-cardiac cavity such as a left atrium.
In some example embodiments, the mapping is based at least on locating bodily openings by differentiating between fluid and non-fluidic tissue (e.g., tissue defining a surface of a bodily cavity). There are many ways to differentiate non-fluidic tissue from a fluid such as blood or to differentiate tissue from a bodily opening in case a fluid is not present. Four approaches may include by way of non-limiting example, and, depending upon the particular approach(es) chosen, the configuration of transducers 406 in Figure 4 may be implemented accordingly:
1. The use of convective cooling of heated transducer elements by fluid. An arrangement of slightly heated transducer elements that is positioned adjacent to the tissue that forms the interior surface(s) of a bodily cavity and across the ports of the bodily cavity will be cooler at the areas which are spanning the ports carrying the flow of fluid.
2. The use of tissue impedance measurements. A set of transducers positioned adjacently to tissue that forms the interior surface(s) of a bodily cavity and across the ports of the bodily cavity may be responsive to electrical tissue impedance. Typically, heart tissue will have higher associated tissue impedance values than the impedance values associated with blood.

3. The use of a differing change in dielectric constant as a function of frequency between blood and tissue. A set of transducers positioned around the tissue that forms the interior surface(s) of the atrium and across the ports of the atrium monitors the ratio of the dielectric constant from 1 kHz to 100 kHz. Such may be used to determine which of those transducers are not proximate to tissue, which is indicative of the locations of the ports.
4. The use of transducers that sense force (i.e., force sensors). A set of force detection transducers positioned around the tissue that forms the interior surface(s) of a bodily cavity and across the bodily openings or ports of the bodily cavity may be used to determine which of the transducers are not engaged with the tissue, which may be indicative of the locations of the ports.
Various ones of the above approaches may be used, at least in part, to determine proximity of a transducer to non-fluidic tissue or to fluidic tissue in some embodiments. Various ones of the above approaches may be used, at least in part, to determine contact between a transducer and non-fluidic tissue or contact between a transducer and fluidic tissue in some embodiments. Various ones of the above approaches may be used, at least in part, to determine an amount of an electrically conductive surface portion of an electrode that contacts non-fluidic tissue or contacts fluidic tissue in some embodiments. Various ones of the above approaches may be used, at least in part, to determine an amount of an electrically conductive surface portion of an electrode that is available to contact non-fluidic tissue or available to contact fluidic tissue in some embodiments.
Referring again to the medical device systems of Figures 3A and 3B, according to some embodiments, electrode-based device system 300 communicates with, receives power from or is controlled by a transducer-activation system 322, which may include a controller 324 and an energy source device system 340. In some embodiments, the controller 324 includes a data processing device system 310 and a memory device system 330 that stores data and instructions that are executable by the data processing device system 310 to process information received from other components of the medical device system of Figures 3A and 3B or to control operation of components of the medical device system of Figures 3A and 3B, for example by activating various selected transducers 306 to ablate tissue, sense tissue characteristics, et cetera.
In this regard, the data processing device system 310 may correspond to at least part of the data processing device system 110 in Figure 1, according to some embodiments, and the memory device system 330 may correspond to at least part of the memory device system 130 in Figure 1, according to some embodiments. The energy source device system 340, in some embodiments, is part of an input-output device system 320, which may correspond to at least part of the input-output device system 120 in Figure 1. Although only a single controller 324 is illustrated, it should be noted that such controller 324 may be implemented by a plurality of controllers. In some embodiments, the electrode-based device system 300 is considered to be part of the input-output device system 320. The input-output device system 320 may also include a display device system 332, a speaker device system 334, or any other device such as those described above with respect to the input-output device system 120.
In some embodiments, elongate members 304 may form a portion or an extension of control leads 317 that reside, at least in part, in the shaft member 316 and, at least in part, in the flexible catheter 314. The control leads terminate at a connector 321 or other interface with the transducer-activation system 322 and provide communication pathways between at least the transducers 306 and the controller 324, according to some embodiments.
As discussed with respect to Figure 4, each of various ones of the transducers 306, 406 includes an electrode 315, 415, according to some embodiments. In these various embodiments, each of at least some of the electrodes 315, 415 may include a respective energy transmission surface (e.g., energy transmission surface 319 in Figure 3A) configured to transfer, transmit, or deliver energy, for example, to tissue. In some embodiments, at least some of the respective energy transmission surfaces 319 are configured to receive energy, for example, from tissue. Each of the energy transmission surfaces may be bound by a respective electrode edge 315-1 (e.g., Figure 3C), 415-1 (e.g., Figure 4).
In various embodiments, each of the electrodes 315 includes an electrically conductive surface portion (e.g., energy transmission surface 319) that, in some embodiments, has an electrical conductivity that is typically greater than that of fluidic and non-fluidic tissue.
In some embodiments, the entirety of the electrically conductive surface portion is configured to contact or is configured to be available or exposed for contact with a contiguous portion of a non-fluidic tissue surface (e.g., a tissue surface that defines a tissue wall).
Complete contact between the entirety of the electrically conductive surface portion and the non-fluidic tissue may be motivated for different reasons. For example, various desired characteristics required in a lesion formed in a tissue wall in a tissue ablation procedure may be dependent on the degree of intimate contact established between the electrically conductive surface portion of the electrode 315 and the tissue wall. For example, intimate contact may be required to form a lesion having sufficient transmurality to act as an effective electrophysiological activity block (e.g, a block capable of folining a barrier to spurious electrical signals causing fibrillation in an atrium). In some cases, complete contact between the entirety of the electrically conductive surface portion and the non-fluidic tissue may be desired to reduce the time required to form a lesion to a desired tissue depth under the influence of a given ablation energy level. In some cases, complete contact between the entirety of the electrically conductive surface portion of the electrode 315 and the non-fluidic tissue may be desired to reduce transmission of ablative energy to a surrounding fluidic tissue. In some cases, complete contact between the entirety of the electrically conductive surface portion of the electrode 315 and the non-fluidic tissue may be desired to reduce or eliminate exposure of the electrically conductive surface portion of the electrode 315 to surrounding fluidic tissue when the electrically conductive surface portion of the electrode 315 is positioned in contact with non-fluidic tissue. In some embodiments, the entirety of the portion of the electrically conductive surface of the electrode 315 that is configured to contact or is configured to be available or exposed (e.g., without some obstruction preventing at least some of the ability) to contact a tissue wall surface includes all of the electrically conductive surface. For example, this may occur when the electrically conductive surface has a generally planar form (e.g., a generally planar conductive surface provided by an electrode formed by flexible circuit fabrication techniques (e.g., electrode 415)). In some embodiments, the entirety of the portion of the electrically conductive surface of the electrode that is configured to contact or is configured to be available or exposed to contact a tissue wall surface includes some, but not all, of the electrically conductive surface. For example, this may occur when the electrode has a generally three-dimensional surface (e.g., a surface having a cylindrical, hemi-spherical or other three-dimensional form) with only a portion less than the entirety of the three-dimensional surface configured to contact or configured to be available or exposed for contact with a tissue surface wall.
In some embodiments, input-output device system 320 may include a sensing device system 325 configured to detect various characteristics or conditions including, but not limited to, at least one of tissue characteristics (e.g., electrical characteristics such as tissue impedance, tissue type, tissue thickness) and thermal characteristics such as temperature. Various other particular conditions may be detected by sensing device system 325 according to various embodiments. It is noted that in some embodiments, sensing device system 325 includes various sensing devices or transducers configured to sense or detect a particular condition while positioned within a bodily cavity. In some embodiments, at least part of the sensing device system 325 may be provided by electrode-based device system 300 (e.g., various ones of transducers 306). In some embodiments, sensing device system 325 includes various sensing devices or transducers configured to sense or detect a particular condition while positioned outside a given bodily cavity or even outside a body that includes the bodily cavity. In some embodiments, the sensing device system 325 may include an ultrasound device system or a fluoroscopy device system or portions thereof by way of non-limiting example.
The energy source device system 340 may, for example, be connected to various selected transducers 306 or their respective electrodes 315 to provide energy in the form of electrical current or energy (e.g, RF energy) to the various selected transducers 306 or their respective electrodes 315 to cause ablation of tissue. In this regard, although Figures 3A and 3B
show a communicative connection between the energy source device system 340 and the controller 324 (and its data processing device system 310), the energy source device system 340 may also be connected to the transducers 306 or their respective electrodes 315 via a communicative connection that is independent of the communicative connection with the controller 324 (and its data processing device system 310). For example, the energy source device system 340 may receive control signals via the communicative connection with the controller 324 (and its data processing device system 310), and, in response to such control signals, deliver energy to, receive energy from, or both deliver energy to and receive energy from one or more of the transducers 306 via a communicative connection with such transducers 306 or their respective electrodes 315 (e.g., via one or more communication lines through catheter body 314, elongated cable 316 or catheter sheath 312 ) that does not pass through the controller 324.
In this regard, the energy source device system 340 may provide results of its delivering energy to, receiving energy from, or both delivering energy to and receiving energy from one or more of the transducers 306 or the respective electrodes 315 to the controller 324 (and its data processing device system 310) via the communicative connection between the energy source device system 340 and the controller 324.
The energy source device system 340 may, for example, provide energy in the fomi of electrical current to various selected transducers 306 or their respective electrodes 315.

Determination of a temperature characteristic, an electrical characteristic, or both, at a respective location at least proximate each of the various transducers 306 or their respective electrodes 315 may be made under the influence of energy or current provided by the energy source device system 340 in various embodiments. Energy provided to an electrode 315 by the energy source device system 340 may in turn be transmittable by the electrodes 315 to adjacent tissue (e.g., tissue forming a tissue wall surface). In various embodiments, the transmittable energy is sufficient for tissue ablation. In some embodiments, the energy is insufficient for tissue ablation.
The energy source device system 340 may include various electrical current sources or electrical power sources. In some embodiments, an indifferent electrode 326 is provided to receive at least a portion of the energy transmitted by at least some of the transducers 306 or their respective electrodes 315. Consequently, although not shown in Figures 3A and 3B, the indifferent electrode may be communicatively connected to the energy source device system 340 via one or more communication lines in some embodiments. The indifferent electrode 326 is typically configured to be positioned outside of a bodily cavity and may be positioned on an exterior body surface and, in some embodiments, although shown separately in Figures 3A and 3B, is considered part of the energy source device system 340.
Structure 308 may be delivered and retrieved at least in part via a catheter member, for example, a catheter sheath 312. In some embodiments, the structure 308 provides expansion and contraction capabilities for a portion of a medical device (e.g., an arrangement, distribution or array of transducers 306). The transducers 306 may form part of, be positioned or located on, mounted or otherwise carried on the structure 308 and the structure may be configurable to be appropriately sized to slide within catheter sheath 312 in order to be deployed percutaneously or intravascularly. Figure 3A shows one embodiment of such a structure 308, where the elongate members 304, in some embodiments, are stacked in the delivery or unexpanded configuration to facilitate fitting within the flexible catheter sheath 312.
In some embodiments, each of the elongate members 304 includes a respective distal or second end 305 (only one called out in each of Figure 3A and 3B), a respective proximal of first end 307 (only one called out in each of Figure 3A and 3B) and an intermediate portion 309 (only one called out in Figure 3A, but two are called out in Figure 3B as 309a and 309b) positioned between the proximal end 307 and the distal end 305. In some embodiments, each elongate member 304 includes a length 328 from the respective distal or second end 305 to the respective proximal or first end 307. Each proximal or first end 307 of each respective elongate member 304 may be a location where such proximal or first end 307 of the structure 308 is coupled to the distal portion (e.g., a portion at least adjacent distal end 316b) of the shaft member 316, in some embodiments.
At least the respective intermediate portion 309 of each elongate member 304 may include a first or front surface or side 318a that is positionable to face away from an interior of the bodily cavity toward an interior tissue surface within a bodily cavity (e.g., Figure 2A) and a second or back surface or side 318b opposite across a thickness 327 of the elongate member 304 from the front surface or side 318a. A width 323 (e.g., Figure 3B) of each respective elongate member 304 is perpendicular to and longer than the thickness 327 and perpendicular to the length 328 of the respective elongate member 304, according to some embodiments. In the expanded configuration, it may be considered that the width 323 of a respective elongate member 304 at a particular location along the elongate member 304 is perpendicular to a tangent of the length 328 of the respective elongate member 304 at the particular location, since the respective elongate member 304 may exhibit curvature.
In some embodiments, all or part of the front surface 318a of each elongate member 304 is an outward-facing surface portion, each outward-facing surface portion positionable to face away from an interior of the bodily cavity and an interior of the structure 308 toward a tissue surface of a wall of the bodily cavity in a state in which the structure 308 is positioned in the bodily cavity in the expanded configuration (e.g, Figure 2A). Similarly, in some embodiments, all or part of the back surface 318b of each elongate member 304 is an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward an interior of the bodily cavity and an interior of the structure 308 in the state in which the structure 308 is positioned in the bodily cavity in the expanded configuration (e.g., Figure 2A).
In some embodiments, all or part of the front surface 318a of each elongate member 304 is an outward-facing surface portion, each outward-facing surface portion positionable to face away from an interior of the structure 308 when the structure 308 is the expanded configuration (e.g., Figures 2B, 3B, 3C, 3D, 3E, 3F, 3G, 311, 31, 3J, 3K, 3L, and 3M).
Similarly, in some embodiments, all or part of the back surface 318b of each elongate member 304 is an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward an interior of the structure 308 when the structure 308 is in the expanded configuration.
In some embodiments, each elongate member 304 includes a twisted portion 345 (only one called out in each of Figures 3A and 3B) at a location proximate proximal end 307 or at least proximate distal end 316b of shaft member 316. Such twisted portion 345 assists in fanning of the elongate members 304 when the structure 308 moves from the delivery configuration (e.g., Figure 3A) to the expanded or deployed configuration (e.g., at least Figure 3B) according to some embodiments. In some embodiments, twisting of respective elongate members 304 at least along an intermediate region 308e is absent or substantially absent when the structure 308 is in the delivery configuration shown, for example, in Figure 3A. Similarly, in some embodiments, at least when the structure 308 is in the delivery configuration, each respective elongate member 304 is free or substantially free from twisting in the respective intermediate portion 309. In other words, while a twisting portion 345 may exist at a location proximate proximal end 307 (for example to assist deployment of the structure 308 from the delivery configuration (e.g., Figure 3A) to the expanded or deployed configuration (e.g., at least Figure 3B)), the intermediate region 308e and intermediate portions 309 may be free or substantially free of twisting, according to some embodiments. Each of the phrases "substantially absent" and "substantially free" in this context means less than 15 degrees of twist in some embodiments, or less than ten degrees, five degrees, or two degrees in other embodiments. It should be noted that each of the terms "absent"
and "free" in this context means less than two degrees or less than one degree, according to some embodiments.
In some embodiments, the elongate members 304 are arranged successively adjacent to one another in a stacked array or stacked arrangement when the structure 308 is in the delivery configuration (e.g., Figure 3A). In particular, in some embodiments, the respective intellnediate portions 309 are arrayed front surface 318a-toward-back surface 318b along a first direction (e.g., direction 338a) in a stacked array or stacked arrangement when the structure 308 is in the delivery configuration. In some embodiments, partial or full separations or gaps may be present between two elongate members 304 of various ones of the successive pairs of elongate members 304 in a stacked array or stacked arrangement. Substantially uniform separations or varying sized separations between the two elongate members 304 of each successive pair of the elongate members 304 in the stacked array or stacked arrangement may be present. In some example embodiments, various other elements may be disposed between two elongate members 304 of various ones of the successive pairs of the elongate members 304 in the stacked array or stacked arrangement. For example, various transducer elements may be positioned between two elongate members 304 of various ones of the successive pairs of the elongate members 304 in the stacked array or stacked arrangement. The elongate members 304 may be linearly arrayed along the first direction (e.g., as represented by direction 338a) in the stacked array or stacked arrangement. In some embodiments, at least three elongate members 304 are linearly arrayed (e.g., front surface 318a-toward-back surface 318b) along a first direction (e.g., as represented by arrow 338a) in an arrayed arrangement (e.g., a stacked arrangement). In some embodiments, at least three elongate members 304 are successively arranged with respect to one another along a first direction (e.g., as represented by arrow 338a) in a stacked array or stacked arrangement.
Elongate members 304 may be substantially planar members or may have some initial curvature when in the delivery configuration. Surface 318a, surface 318b, or both, need not be flat, according to some embodiments. For example, in embodiments where the electrodes 315 are considered part of their respective elongate members, the energy transmission surfaces 319 of such electrodes 315 may respectively represent an elevated surface portion of the respective front surface 318a of the respective elongate member 304. However, in some embodiments, the energy transmission surfaces 319 may be flush (e.g., flush to the touch) with other surface portions of the respective elongate member 304, at least in some embodiments where the respective front surface 318a of the respective elongate member 304 is flat.
In Figure 3A, elongate members 304 have a shape that allows them to be successively stacked in a stacked arrangement. A stacked arrangement advantageously allows elongate members 304 to be arranged in a substantially spatially efficient manner to allow for delivery through a catheter sheath (e.g., catheter sheath 312) enabling a reduced dimension (e.g., a diameter dimension) of such catheter sheath.
The transducers 306 may be arranged in various distributions or arrangements in various embodiments. In some embodiments, various ones of the transducers 306 are spaced apart from one another in a spaced apart distribution as shown, for example in at least Figures 3A
and 3B. In some embodiments, various regions of space are located between various pairs of the transducers 306. For example, in Figure 3B the electrode-based device system 300 includes at least a first transducer 306a, a second transducer 306b, and a third transducer 306c (all collectively referred to as examples of transducers 306). In some embodiments, each of the first, the second, and the third transducers 306a, 306b, and 306c are adjacent transducers in the spaced apart distribution. In some embodiments, the first and the second transducers 306a, 306b are located on different elongate members 304 while the second and the third transducers 306b, 306c are located on a same elongate member 304. In some embodiments, a first region of space 350 is between the first and the second transducers 306a, 306b. In some embodiments, the first region of space 350 is not associated with any physical portion of structure 308. In some embodiments, a second region of space 360 associated with a physical portion of device system 300 (e.g., a portion of an elongate member 304) is between the second and the third transducers 306b, 306c.
In some embodiments, each of the first and the second regions of space 350, 360 does not include a transducer or electrode thereof of electrode-based device system 300. In some embodiments, each of the first and the second regions of space 350, 360 does not include any transducer or electrode.
It is noted that other embodiments need not employ a group of elongate members 304 as employed in the illustrated figures. For example, other embodiments may employ a structure including one or more surfaces, at least a portion of the one or more surfaces defining one or more openings in the structure. In these embodiments, a region of space not associated with any physical portion of the structure may extend over at least part of an opening of the one or more openings. In other example embodiments, other structures may be employed to support or carry transducers of a transducer-based device such as a transducer-based catheter. For example, basket catheters or balloon catheters may be used to distribute the transducers in a two-dimensional or three-dimensional array.
In various example embodiments, the energy transmission surface 319 of each electrode 315 is provided by an electrically conductive surface. In some embodiments, each of the electrodes 315 is located on various surfaces of an elongate member 304 (e.g., front surfaces 318a or back surfaces 318b). In this regard, in some embodiments, each of one or more electrodes 315 is provided at least in part on the first side or front surface 318a, the second side or back surface 318b, or both the first side 318a and the second side 318b of a respective elongate member 304. In some embodiments, each of one or more electrodes 315 is located on one, but not both of the front surface 318a and back surface 318b of a respective elongate member 304.
For example, various electrodes 315 may be located only on the respective front surfaces 318a of each of the various ones of the elongate members 304. Three of the electrodes 315 are identified as electrodes 315a, 315b, and 315c in Figure 3B. Three of the energy transmission surfaces 319 are identified as 319a, 319b, and 319c in Figure 3B. In various embodiments, it is intended or designed to have the entirety of each of various ones of the energy transmission surfaces 319 be available or exposed (e.g., without some obstruction preventing at least some of the ability) to contact non-fluid tissue at least when structure 308 is positioned in a bodily cavity in the expanded configuration. In various embodiments, it is intended or designed to have no portion of each of at least one of the energy transmission surfaces 319 contact fluidic tissue when the at least one of the energy transmission surfaces 319 contacts a contiguous portion of a non-fluidic tissue surface (e.g., a tissue surface that defines a tissue wall).
In some embodiments, like those shown in Figure 3B, the respective intermediate portions 309 of various ones of the elongate members 304 are angularly arranged with respect to one another about a first axis 335a when structure 308 is in the deployed configuration. Figure 3C is a plan view of structure 308 in the deployed or expanded configuration of Figure 3B.
Illustrated in Figure 3C is the first axis 335a, which may be considered an axis of the structure 308, and which is represented by an "x" symbol in Figure 3C as entering and coming out of the page (Figure 3C represents a polar view of the structure 308 in the deployed configuration according to some embodiments). It is understood that the depicted symbol "x"
used to represent first axis 335a does not impart any size or shape attributes to the first axis 335a. In some embodiments, the first axis 335a is oblique with respect to an extension direction of a second axis 335b (e.g., shown at least in Figures 3B, 3D, and 31) in which the shaft member 316 extends at the distal end 316b. (It is noted that various elongate members 304 in Figure 3D have been partially sectioned away (i.e., as compared with elongate members 304y1 and 304y2 in Figure 3B) to better show first axis 335a and its relationship with various ones of the elongate members 304. Similarly, it is noted that an elongate member 304a has been partially sectioned away in Figure 31 to better show first axis 335a and its relationship with various ones of the elongate members 304.) In this regard, the second axis 335b may be collinear with the longitudinal axis 339d of the shaft member 316 at the distal end 316b of the shaft member 316.
The second axis 335b (or longitudinal axis 339d when collinear with the second axis 335b) may extend through a center (e.g., centroid or geometric center) of a cross-section 339c (Figure 3B) of the shaft member 316 at or adjacent the distal end 316b of the shaft member 316. As shown more clearly in Figure 31, the second axis 335b (or a collinear portion of the longitudinal axis 339b extending outwardly from the distal end 316b of the shaft member 316) does not intersect the first axis 335a according to some embodiments. It is understood that that shaft member 316 is a flexible member in some embodiments. Accordingly, the longitudinal axis 339d of catheter member 316 need not be straight within various portions of shaft member 316, but rather may follow a bend associated with these various portions of shaft member 316. Nonetheless, the longitudinal axis 339b extends outwardly in a straight-line path from the proximal and distal ends 316a, 316b of shaft member 316 (for example, as shown in Figure 3D).
In some embodiments, at least one of the elongate members 304 crosses another of the elongate members 304 (for example, in an X configuration) at a location proximate a first axis 335a. As shown in Figures 3C and 3D, various ones of the elongate members 304 are fanned about first axis 335a. In some embodiments, first axis 335a passes through a plurality of spaced apart locations along the respective length 328 of each of at least some of the elongate members 304 when structure 308 is in the expanded or deployed configuration. It is noted that although Figure 3A illustrates only one length 328 of one elongate member 304, other elongate members may have the same or a different length than the length 328 illustrated in Figure 3A. In various embodiments, first axis 335a may pass through two or more spaced apart locations along the respective length 328 of each of at least one of the elongate members 304. In various embodiments, first axis 335a may pass through three or more spaced apart locations along the respective length 328 of each of at least one of the elongate members 304. For example, as shown in Figure 31, axis 335a may pass through at least a first elongate member 304 (e.g., elongate member 304a) at a first location proximate the respective proximal end 307, a second location on the respective intermediate portion 309, and a third location proximate the respective distal end 305 of the first elongate member 304, each of the first, the second, and the third location spaced from each of the others of the first, the second, and the third locations along the respective length 328 of the first elongate member 304.
In some embodiments, each of the at least some of the plurality of elongate members 304 includes a curved portion 337 (two called out in Figure 3B) arranged to extend along at least a portion of a respective curved path that intersects the first axis 335a at each of a respective at least two spaced apart locations along first axis 335a when the structure 308 is in the expanded or deployed configuration. In various embodiments, a curved portion 337 of an elongate member 304 may extend entirely along, or at least part way along a respective curved path that intersects the first axis 335a at each of a respective at least two spaced apart locations along first axis 335a when the structure 308 is in the expanded or deployed configuration. In some embodiments, each of the elongate members 304 includes a curved portion 337 including a curvature configured to cause the curved portion 337 to extend along at least a portion of a curved path, the curvature configured to cause the curved path to intersect the first axis 335a at each of a respective at least two spaced apart locations along the first axis 335a when structure 308 is in the expanded or deployed configuration. In some embodiments, the curved path is defined to include an imagined extension of the curved portion 337 along the curved portion's extension direction while maintaining the curved portion's curvature (e.g., radius of curvature or change in radius of curvature) at a location where the curved portion 337 ends and the imagined extension begins. In some embodiments, each curved portion 337 may extend entirely along, or at least part way along, the respective curved path to physically intersect at least one of the respective at least two spaced apart locations along the first axis 335a. In some particular embodiments, no physical portion of a given elongate member 304 of an employed structure intersects some of the at least two spaced apart locations along the first axis 335a intersected by the respective curved path associated with the curved portion 337 of the given elongate member 304. In various embodiments, the curved path is an arcuate path. In various embodiments, at least the portion of the curved path extended along by curved portion 337 is arcuate. In some embodiments, at least a first elongate member 304 crosses a second elongate member 304 (e.g., in an X configuration) at each of at least one of the respective at least two spaced apart locations along the first axis 335a intersected by at least the portion of the respective curved path extended along by the curved portion 337 of the second elongate member 304 when the structure 308 is in the expanded or deployed configuration. In some embodiments, at least a first elongate member 304 crosses a second elongate member 304 at each of the respective at least two spaced apart locations along the first axis 335a intersected by at least the portion of the respective curved path extended along by the curved portion 337 of the second elongate member 304 when the structure 308 is in the expanded or deployed configuration. In various embodiments, each respective curved portion 337 of all of the plurality of elongate members is arranged to extend along at least a portion of a respective curved path that intersects the first axis 335a at each of a respective at least two spaced apart locations along first axis 335a when the structure 308 is in the expanded or deployed configuration. In various embodiments, the respective curved portions 337 of all of the plurality of elongate members 304 are circumferentially arranged about first axis 335a when structure 308 is in the expanded or deployed configuration. For example, at least part of each of the elongate members 304 (e.g., at least the intermediate portion 309 or the curved portion 337) are circumferentially arranged about the first axis 335a, in the same or similar manner as lines of longitude about an axis of rotation of a body of revolution, which body of revolution may, or may not, be spherical.
The terms "radially arranged" and "angularly arranged" may be used interchangeably, to refer to an arrangement that is the same or similar to lines of longitude distributed at least partially (e.g., hemispherically) about an axis (e.g., polar or other axis) of a body (e.g., body of revolution), which may, or may not, be spherical. In some embodiments, a first portion of the front surface 318a of each elongate member 304 is positionable, when the structure 308 is in the expanded or deployed configuration, to face a first portion of the interior tissue surface of a bodily cavity and a second portion of the front surface 318a of the elongate member 304 is positionable, when the structure 308 is in the expanded or deployed configuration, to face a second portion of the interior tissue surface, the second portion of the interior tissue surface positioned diametrically opposite from the first portion of the interior tissue surface. In some embodiments, a first portion of the front surface 318a of each elongate member 304 is positionable, when the structure 308 is in the expanded or deployed configuration, to face outwardly from an interior of the structure 308, and a second portion of the front surface 318a of the elongate member 304 is positionable, when the structure 308 is in the expanded or deployed configuration, to face outwardly from the interior of the structure 308, the second portion of the front surface 318a of the elongate member 304 positioned diametrically opposite across the interior of the structure 308 from the first portion of the front surface 318a of the elongate member 304.
Returning to Figure 3C, in some embodiments, each of the elongate members 304 includes a respective portion (e.g., at least a portion of intermediate portion 309, at least a portion of curved portion 337) radially spaced from the first axis 335a when the structure 308 is in the expanded configuration, the respective portions of the elongate members 304 circumferentially arranged about the first axis 335a when the structure is in the expanded configuration. Similarly, in various embodiments, at least some of the electrodes 315 are radially spaced about or from a first axis 335a when structure 308 is in the deployed configuration. For example, various ones of the electrodes 315 are radially spaced about first axis 335a in the deployed configuration in at least some of the embodiments associated with various ones of at least Figures 3B-3M. In various embodiments, at least some of the electrodes 315 are circumferentially arranged about first axis 335a when structure 308 is in the deployed configuration. For example, various ones of the electrodes 315 are circumferentially arranged about first axis 335a in the deployed configuration in at least some of the embodiments associated with various ones of at least Figures 3B-3M. In some embodiments, a central electrode 315-e exists (e.g., as shown by the polar or plan view of a distal hemisphere of a structure 308-1 in Figure 3J), through which a first axis 335a-1 passes through structure 308-1 in a distal hub region 308d (described below) in the deployed configuration, the structure 308-1 being similar in form to structure 308 in terms of it use and positioning of elongate members. It is understood that although electrodes 315 are referred to in these described embodiments, the same analysis applies to the corresponding transducers 306 in some embodiments. In Figure 3C, the electrodes 315 are arranged according to some embodiments in which the first axis 335a does not pass through a central electrode. The presence or non-presence of a central electrode may be dependent on various factors including a required size of the device and particular anatomy characteristics into which the device is deployed. For example, different bodily cavities have different sizes and shapes and, therefore, different sizes and shapes of various parts of the electrode-based device system 300 (e.g., structure 308) may be appropriate to match the different sizes and shapes of the bodily cavities, according to some embodiments. Different bodily cavities may have different anatomical features or different positionings of various anatomical features. Accordingly, in some embodiments, it may be beneficial to have an arrangement of transducers or electrodes in which a central electrode exists like electrode 315-2 in Figure 3J. In other applications, it may be beneficial to have an arrangement of transducers or electrodes in which a central electrode like electrode 315-2 does not exist, such as the configurations shown in Figures 3C, 3E, and 31.
It may be noted that distances between adjacent ones of the elongate members shown in at least Figures 3B and 3C vary as elongate members 304 extend toward first axis 335a when structure 308 is in the deployed configuration. In some cases, the varying distances between adjacent elongate members 304 in the deployed configuration may give rise to shape, size or dimensional constraints for the electrodes 315 located on the elongate members 304. In some cases, the overlapping portions of various ones of the elongate members 304 in the deployed configuration may give rise to shape, size or dimensional constraints for the electrodes 315 located on the portions of the various ones of the elongate members 304.
For example, it may be desirable to reduce a surface area of an electrode adjacent an overlap region on an overlapped elongate member to accommodate the reduced exposed surface area of the overlapped elongate member in the region adjacent the overlap region (e.g., electrode 315d in Figure 3C).
In various embodiments, the respective shape of various electrically conductive surfaces (e.g., energy transmission surfaces 319) of various ones of the electrodes 315 vary among the electrodes 315. In various embodiments, the respective shape of various electrically conductive surfaces (e.g., energy transmission surfaces 319) of various ones of the electrodes 315 vary among the electrodes 315 in accordance with their proximity to first axis 335a. In various embodiments, one or more dimensions or sizes of various electrically conductive surfaces (e.g., energy transmission surfaces 319) of at least some of the electrodes 315 vary among the electrodes 315. In various embodiments, one or more dimensional sizes of various electrically conductive surfaces (e.g., energy transmission surfaces 319) of at least some of the electrodes 315 vary in accordance with their proximity to first axis 335a. The shape or size variances associated with various ones of the electrodes 315 may be motivated for various reasons.
For example, in various embodiments, the shapes or sizes of various ones of the electrodes 315 may be controlled in response to various ones of the aforementioned size or dimensional constraints.
In some embodiments, structure 308 includes a proximal portion 308a and a distal portion 308b (e.g., at least Figure 3B). In some embodiments, the proximal and the distal portions 308a, 308b include respective parts of each of the elongate members 304 each respective part being less than an entirety of the elongate member 304. In some embodiments, the structure 308, when in the expanded configuration (e.g., at least Figures 3B and 3C), includes a distal hub region 308d and a proximal hub region 308c. In some embodiments, the proximal portion 308a may represent respective portions of the elongate members 304 adjacent, along the lengths 328 of such elongate members 304, the proximal ends 307 of such elongate members 304, while the distal portion 308b may represent respective portions of the elongate members 304 adjacent, along the lengths 328 of such elongate members 304, the distal ends 305 of such elongate members. In some embodiments, the distal portion 308b is arranged to be advanced ahead of the proximal portion 308a when the structure 308 is delivered in the delivery configuration (e.g., Figure 3A) though a bodily opening leading to a bodily cavity (e.g., in a percutaneous or intravascular procedure).
In some embodiments, the proximal hub region 308c may represent respective portions of the elongate members 304 closest, in three-dimensional space (e.g., straight line distance through three-dimensional space), to the proximal ends 307 of such elongate members 304 when the structure 308 is in the expanded configuration. In some embodiments, for a particular elongate member 304 when the structure 308 is in the expanded configuration, at least a portion of the proximal hub region 308c may represent (a) a first portion of the particular elongate member 304 at or adjacent, along the length 328 of the particular elongate member 304, the proximal end 307 of the particular elongate member 304, and (b) a second portion of the particular elongate member 304 at or adjacent, along the length 328 of the particular elongate member 304, the distal end 305 of the particular elongate member 304, where the respective proximal end 307 and the respective distal end 305 are adjacent when the structure 308 is in the expanded configuration (e.g., as shown at least in Figure 3B and 31). In some embodiments, the first portion and the second portion are spaced from each other by a gap (e.g., gap 329 shown in Figure 31) at least between the respective proximal end 307 and distal end 305 when the structure 308 is in the expanded configuration (e.g., as shown at least in Figure 3B).
In this regard, various portions of each elongate member 304 located at least adjacent respective ones of the proximal end 307 and the distal end 305 of the particular elongate member 304 may reside within a perimeter (e.g., as defined according to various embodiments herein) of the proximal hub region 308c when the structure 308 is in the expanded configuration. For example, as shown in the partially sectioned view of structure 308 in Figure 31, at least the respective distal end 305 and a portion adjacent the proximal end 307 of each of various ones of the elongate members 304 are included within a perimeter of the proximal hub region 308c when the structure 308 is in the expanded configuration, according to some embodiments.
In some embodiments, the distal hub region 308d may represent respective portions of the elongate members 304 furthest, in three-dimensional space (e.g., straight line distance through three-dimensional space), from the proximal ends 307 of the elongate members 304 when the structure 308 is in the expanded configuration. In some embodiments, for a particular elongate member 304 when the structure 308 is in the expanded configuration, the distal hub region 308d may include a part or region of the intermediate portion 309 or curved portion 337 of the particular elongate member 304 that is furthest, in three-dimensional space, from the proximal end 307 of the particular elongate member 304. In some embodiments, for a particular elongate member 304 when the structure 308 is in the expanded configuration, the distal hub region 308d may include a part or region of the intermediate portion 309 or curved portion 337 of the particular elongate member 304 that is furthest along the respective length 328 of the particular elongate member from each of the proximal end 307 and the distal end 305 of the particular elongate member 304. In this regard, neither the proximal end 307 nor the distal end 305 of each elongate member 304 resides within a perimeter (e.g., as defined according to various embodiments herein) of the distal hub region 308d when the structure 308 is in the expanded configuration, according to some embodiments. In some embodiments, the distal hub region 308d is located further from the distal end 316b of the shaft member 316 than the proximal hub region 308c at least when the structure 308 is in the expanded configuration.
In some embodiments, the proximal hub region 308c may represent respective portions of the elongate members 304 closest, in three-dimensional space (e.g., straight line distance through three-dimensional space), to the proximal ends 307 of the elongate members 304, and the distal hub region 308d may represent respective portions of the elongate members 304 closest, in three-dimensional space, to the distal ends 305 of such elongate members 304.
For example, in various embodiments, a structure including a plurality of elongate members that include respective proximal and distal ends may be advanced in a delivery configuration to a bodily cavity with each of the respective distal ends advanced ahead of respective ones of the proximal ends. The structure may be moved from the delivery configuration into an expanded configuration in which the respective distal ends of the elongate members are closer in three-dimensional space to the distal hub region of the structure than the proximal hub region of the structure and in which the respective proximal ends of the elongate members are closer in three dimensional space to the proximal hub region of the structure than the distal hub region of the structure. Such embodiments may include a basket-type structure including elongate members whose respective proximal ends converge toward the proximal hub region of the basket-type structure and whose respective distal ends converge toward the distal hub region of the basket-type structure.
When the structure 308 is in the expanded configuration, the elongate members 304 of the plurality of elongate members 304 converge in each of the distal hub region 308d and the proximal hub region 308c and diverge toward an intermediate region 308e (shown in at least Figure 3B) located between the distal hub region 308d and the proximal hub region 308c according to various embodiments. In some embodiments, when the structure 308 is in the expanded configuration, such as that shown by at least Figures 3B and 3C, the structure 308 may be considered to encompass a volume dividable by a plurality of equally spaced lines of latitude.
For example, assume that the structure 308 encompasses a volume including a first pole 331a (shown at least in Figure 3B) residing in the proximal hub region 308c and an opposite second pole 331 b residing in the distal hub region 308d (shown at least in Figure 3C), with the volume divided by lines of latitude 333, some shown as 333a, 333b, 333c, 333d, and 333e in Figures 3B
and 3C, progressing in an equally spaced manner along an axis extending from the first pole 331a to the second pole 331b. Latitude 333c represents the equator of the volume.
In this case, each of the distal hub region 308d and the proximal hub region 308c may be defined to include one-fifth (i.e., twenty percent) of the lines of latitude 333a-333e from its respective pole, according to some embodiments. For example, in some embodiments, the distal hub region 308d may be defined to have its boundary with the intermediate region 308e at latitude 333e, and the proximal hub region 308c may be defined to have its boundary with the intermediate region 308e at latitude 333a. While defining a perimeter of the distal hub region 308d and the proximal hub region 308c to be at these respective one-fifth latitude marks may be beneficial in some circumstances, other latitude proportions may be beneficial in other embodiments, such as each of the distal hub region 308d and the proximal hub region 308c encompassing one-fourth, one-eighth, or one-tenth, of the lines of latitude of the volume enclosed by the structure 308 when in the expanded configuration. Further, the distal hub region 308d and the proximal hub region 308c need not encompass the same latitude proportions in some embodiments. For instance, the distal hub region 308d may be defined to encompass a first percentage (e.g., one-fifth or some other proportion) of the lines of latitude, and the proximal hub region 308c may be defined to encompass a second percentage (e.g., one-fourth or some other proportion) of the lines of latitude different than the first percentage. In some embodiments, the lines of latitude 333 are separated from one another by an equal distance along an exterior surface of the volume.
In some embodiments, the lines of latitude 333 are separated from one another by an equal distance along the first axis 335a.

In some embodiments, the first axis 335a may extend between and through a center of the distal hub region 308d and a center of the proximal hub region 308c. In some embodiments, such center of the distal hub region 308d may correspond to a geometric center or centroid of a shape defined by the distal hub region 308d (e.g., a geometric center of a shape defined by a perimeter of the distal hub region 308d). In some embodiments, such center of the proximal hub region 308c may correspond to a geometric center or centroid of a shape defined by the proximal hub region 308c (e.g., a geometric center of a shape defined by a perimeter of the proximal hub region 308c). In some embodiments, a center of a respective one of the proximal hub region 308c or the distal hub region 308d is not a geometric center or centroid thereof. For example, a center of a respective one of the proximal hub region 308c or the distal hub region 308d may correspond to a midway point in each of at least one overall dimension of the structure 308 in the expanded configuration as viewed in a direction normal to the respective one of the proximal hub region 308c or the distal hub region 308d. In some embodiments, one such dimension is a dimension 308e-1 (e.g., as shown in Figure 3C) of the intermediate region 308e, the dimension 308e-1 transverse to the first axis 335a (e.g., as shown in Figure 3C), according to some embodiments. The dimension 308e-1 may represent an equatorial diameter of the structure 308. The dimension 308e-1 may vary (e.g., increase) in magnitude during a movement of the structure 308 between the delivery configuration (e.g., at least Figure 3A) and the expanded configuration (e.g., at least Figure 3B and 3C) with the dimension having a peak in magnitude when the structure 308 is in the expanded configuration (e.g., at least Figures 3B and 3C), according to some embodiments. In some embodiments, a center of the distal hub region 308d is defined as a point on the structure 308 furthest from the proximal ends 307 of the elongate members 304 when the structure 308 is in the expanded configuration. In such a case, the center of the proximal hub region 308c may be on the opposite side of the structure 308 from the center of the distal hub region 308d.
In some embodiments, when the structure 308 is in the expanded configuration, each of the elongate members 304 includes a curved portion (e.g., along the respective length 328 such as curved portion 337) that intersects the first axis 335a at each of a respective at least two spaced apart locations along the first axis 335a (e.g., at an intersection location at a center of the distal hub region 308d as viewed along first axis 335a and an intersection location at a center of the proximal hub region 308c as viewed along first axis 335a). It is noted that, although the first axis 335a may pass through a center of the distal hub region 308d, the second axis 335b (or collinear portion of the longitudinal axis 339b extending outwardly from the distal end 316b of the shaft member 316) does not, according to some embodiments as shown at least in Figures 3B, 3D, and 31.
As shown at least in Figure 3C, the distal hub region 308d may include an overlapping region 308d-1 where elongate members 304 at least partially overlap each other (i.e., at least a first elongate member 304 at least partially overlaps a second elongate member 304, and at least the second elongate member 304 is at least partially overlapped by the first elongate member 304) or extend across one another, at least when viewed from a direction co-linear with the first axis 335a (e.g., a direction along the first axis 335a or normal to the distal hub region 308d in some embodiments), when the structure 308 is in the expanded configuration. In some embodiments, this overlapping region 308d-1 may be deemed to be a region where elongate members 304 are stacked or layered. In some embodiments, this overlapping region 308d-1 may be deemed to be a region where respective portions of various ones of the elongate members 304 overlap or are overlapped by respective portions of other ones of the elongate members 304 in a front surface 318a-toward-back surface 318 configuration. The overlapping region 308d-1 may include a combination of individual overlapping regions or sub-regions 308d-la (only two shown in Figure 3C, each as a bold-outlined region for clarity), each individual overlapping sub-region 308d-la associated with a portion of each elongate member 304 that overlaps or is overlapped by a portion of at least one other elongate member 304 (e.g., at least one other, but not all others of the elongate members 304). In some embodiments, the distal hub region 308d may be considered a region where the elongate members 304 meet. The same may be said for the proximal hub region 308c (e.g., as shown in partially sectioned view in Figure 31), i.e., that the elongate members 304 also meet in an overlapping manner in the proximal hub region 308c according to some embodiments.
In some embodiments, the outward-facing surface portions (e.g, portions of the front surfaces 318a) of the elongate members 304 face a same direction when the structure 308 is in the expanded configuration. For example, (a) the outward-facing surface portions of the elongate members 304 at least at a center (or where axis 335a passes through) of the distal hub region 308d may face a same direction, or (b) the outward-facing surface portions (e.g., at or near distal ends 305) of the elongate members 304 at least at a center (or where axis 335a passes through) of the proximal hub region 308c may face a same direction, or both (a) and (b).
For example, when the structure 308 is in the expanded configuration, the outward-facing surface portion (e.g., a portion of the front surface 318a) of a first particular elongate member 304g crosses behind the outward-facing surface portion of an overlying second particular elongate member 304c in the distal hub region 308d shown in Figure 3C, when the outward-facing surface portion of the second particular elongate member 304c is viewed from a direction opposite the same direction that the outward-facing surface portions of both the first and the second particular elongate members 304g, 304c face. In some embodiments, the outward-facing surface portion of the first particular elongate member 304g contacts an inward-facing surface portion (e.g., a portion of back surface 318b) of the second particular elongate member 304c when the structure 308 is in the expanded configuration. In various embodiments, the outward-facing surface portions of various ones of the elongate members 304 are provided by portions of the respective front surfaces 318a of the various ones of the elongate members 304.
In some embodiments, at least the outward-facing surface portion (e.g., a portion of the front surface 318a) of a first particular one of a first sub-group of elongate members (e.g., a first sub-group of elongate members including elongate members 304c, 304d) of the plurality of elongate members 304 contacts the inward-facing surface portion (e.g., a portion of back surface 318b) of a second particular one of the first sub-group of the plurality of elongate members when the structure 308 is in the expanded configuration. For example, in some embodiments, the first particular one of the first sub-group of elongate members is elongate member 304d, and the second particular one of the first sub-group of elongate members is elongate member 304c, such that the outward-facing surface portion of elongate member 304d contacts the inward-facing surface portion of elongate member 304c, as shown, for example, at least in Figure 3C within the distal hub region 308d when the structure 308 is in the expanded configuration.
In some embodiments, the outward-facing surface portion (e.g., a portion of the front surface 318a) of a first particular one of a second sub-group of elongate members (e.g., second sub-group of elongate members including elongate members 304a, 304b) of the plurality of elongate members contacts the inward-facing surface portion (e.g., a portion of back surface 318b) of a second particular one of the second sub-group of the plurality of elongate members when the structure 308 is in the expanded configuration. For example, in some embodiments, the first particular one of the second sub-group of elongate members is elongate member 304a, and the second particular one of the first sub-group of elongate members is elongate member 304b, such that the outward-facing surface portion of elongate member 304a contacts the inward-facing surface portion of elongate member 304b, as shown, for example, at least in Figure 3C within the distal hub region 308d when the structure 308 is in the expanded configuration.
In some embodiments, the perimeter of the distal hub region 308d may be defined, at least in part, from extremities of the individual overlapping sub-regions 308d-la associated with a portion of each elongate member 304 that overlaps or is overlapped by a portion of at least one other of the elongate members 304 in the distal hub region 308d (or the proximal hub regions 308c in some embodiments) when viewed from a direction normal to the distal hub region 308d (or along the first axis 335a) when the structure 308 is in the expanded configuration. Such extremities may be defined as points 308d-lb (four called out in Figure 3C) in the individual overlapping sub-regions 308d-la that are furthest from a center of the distal hub region 308d according to some embodiments. In some embodiments, such extremities may be defined as points 308d-lb (four called out in Figure 3C) in the individual overlapping sub-regions 308d-la that are furthest (e.g., radially furthest) from a center (e.g., a location of the "x" for the first axis 335a in Figure 3C) of the distal hub region 308d where elongate members 304 overlap each other when the structure 308 is in the expanded configuration as viewed in a direction along the first axis 335a. In this regard, the perimeter of the distal hub region 308d may be defined, at least in part, by connected (e.g., straight) line segments between such extremities. In Figure 3C, these connected line segments form closed shape 308d-3, which may define the perimeter of the distal hub region 308d in some embodiments. It is noted that in various embodiments, (a) a direction normal to the distal hub region 308d, or (b) a direction normal to the proximal hub region 308c, or each of (a) and (b) may be parallel to the first axis 335a. It is noted that in various embodiments, (a) a direction normal to the distal hub region 308d, or (b) a direction normal to the proximal hub region 308c, or each of (a) and (b) may be collinear with the first axis 335a.
In some embodiments, each of a plurality of crossing points 308d-1c (two shown in Figure 3C) is defined as a location where edges 303 (two called out in Figure 3C as 303a, 303b) of at least a pair 313 (e.g., two adjacent ones) of elongate members 304 cross when viewed from a direction normal to the distal hub region 308d (or the proximal hub region 308c in some embodiments) when the structure 308 is in the expanded configuration. In various embodiments, the intermediate portion 309 of each elongate member 304 includes a respective pair of edges 303 (also referred to as side edges 303) that define a portion of a periphery of the front surface 318a, the back surface 318b, or both the front surface 318a and the back surface 318b. The side edges 303 of each respective pair of side edges 303 are opposed to one another across at least a portion of the length 328 of the elongate member 304 extending between the proximal and distal ends 307, 305 of the elongate member 304, according to some embodiments. The side edges 303 of each respective pair of side edges 303may be opposite to each other across the width 323 (Figure 3A) of the respective elongate member 304.
In some embodiments, Figure 3C represents a view of structure 308 in the deployed or expanded configuration from a direction normal to the distal hub region 308d. Such direction may be along, collinear with, or parallel to, the first axis 335a.
All the elongate members 304 may overlap each other front surface 318a-toward-back surface 318b along a first direction at a particular location in the distal hub region 308d when the structure 308 is in the expanded configuration, and the direction normal to the distal hub region 308d may be along, collinear with, or parallel to, the first direction. In some embodiments, each of the crossing points 308d-lc may be defined as a location in the distal hub region 308d that does not overlap any elongate member 304 not comprised by the at least the respective pair 313 when the structure 308 is in the expanded configuration or as a location in the distal hub region 308d that is not overlapped by any elongate member 304 not comprised by the respective pair 313 of elongate members 304 when the structure 308 is in the expanded configuration. For instance, it may be considered that each crossing point 308d-lc is at a location not overlapping or overlapped by an elongate member 304.
In Figure 3C, each respective one of these crossing points 308d-lc corresponds to a respective one of the extremity points 308d-lb, but this need not be the case in other embodiments. In some embodiments, adjacent ones of the crossing points 308d-lc may be connected by respective (e.g., straight) line segments to form a closed shape 308d-4 that defines the perimeter or boundary of the distal hub region 308d. In Figure 3C, the closed shape 308d-4 formed by connecting the crossing points 308d-lc is the same as the closed shape 308d-3 formed by connecting the extremity points 308d-lb, but this need not be the case in other embodiments.
In some embodiments, the crossing points 308d-lc may be infinitesimally separated or distant from extremity points 308d-lb, even though they are shown together in Figure 3C. In particular, each respective crossing point 308d-le may be a location just radially outward from a center (e.g., geometric center) of the distal hub region 308d as compared to the respective extremity point 308d-lb, such that the respective extremity point 308d-lb marks a location of elongate member overlap, but the respective crossing point 308d-lc marks a location where no elongate member overlap begins (when moving in a direction radially outward from a center of the distal hub region 308d), according to some embodiments.
In some embodiments, the perimeter or boundary of the distal hub region 308d is defined where overlapping of elongate members 304 ceases around the distal hub region 308d when the structure 308 is in the expanded configuration. In Figure 3C, such a perimeter corresponds to radially outermost edges of the individual overlapping regions or sub-regions 308d-la (only two called out in Figure 3C for clarity).
In view of the above discussion, it can be seen that the perimeter or boundary of the distal hub region 308d may be defined in any number of manners, each of which may provide its own benefits. Regardless of the particular definition selected for the perimeter or boundary of the distal hub region 308d, the selected perimeter or boundary may be defined to abut the intermediate region 308e.
As shown at least in Figure 3C, when viewed from a direction normal to the distal hub region 308d (e.g., viewed along first axis 335a), at least a portion of each elongate member 304 overlaps or is overlapped by at least a portion of at least one other of the elongate members 304 in the distal hub region 308d when the structure 308 is in the expanded configuration, according to some embodiments. Similarly, when viewed from a direction normal to the distal hub region 308d, a portion of each elongate member 304 overlaps or is overlapped by a portion of each of the others of the elongate members 304 in the distal hub region 308d when the structure 308 is in the expanded configuration, according to some embodiments.
For example, in some embodiments, at a location where the first axis 335a passes through all of the elongate members 304 in the distal hub region 308d (e.g., at the location of the "x"
representing the first axis 335a in Figure 3C), all elongate members (e.g., that include electrodes 315) overlap each other or extend across one another. Such a region where all elongate members overlap each other may define the size and boundary of the distal hub region 308d in some embodiments.
As shown in Figure 3C, in some embodiments, when viewed along an axis of the structure 308 (e.g., the first axis 335a), (i) each elongate member 304 in the distal hub region 308d is crossed (e.g., in an X configuration) by another elongate member 304 in the distal hub region 308d when the structure 308 is in the expanded configuration, or (ii) each elongate member 304 in the distal hub region 308d crosses (e.g., in an X configuration) another elongate member 304 in the distal hub region 308d when the structure 308 is in the expanded configuration. Similarly, with respect to Figure 3B and 31, in some embodiments, when viewed along an axis of the structure 308 (e.g., the first axis 335a), (iii) each elongate member 304 in the proximal hub region 308c is crossed by another elongate member 304 in the proximal hub region 308c when the structure 308 is in the expanded configuration, or (iv) each elongate member 304 in the proximal hub region 308c crosses another elongate member 304 in the proximal hub region 308c when the structure 308 is in the expanded configuration. In this regard, in some embodiments, each elongate member 304 in the proximal hub region 308c is overlapped by another elongate member 304 in the proximal hub region 308c when the structure 308 is in the expanded configuration, or each elongate member 304 in the proximal hub region 308c overlaps another elongate member 304 in the proximal hub region 308c when the structure 308 is in the expanded configuration.
It is noted that the perimeter of the distal hub region 308d as defined in one example shown in Figure 3C by the closed shape 308d-3 may have varying degrees of non-uniformity or asymmetry according to various embodiments. For example, the generally elliptical shape of closed shape 308d-3 is interrupted by a notch 311. Various degrees of non-uniformity or asymmetry in the closed shape 308d-3, which may define a perimeter or boundary of distal hub region 308d according to various embodiments, may arise for various reasons. For example, non-uniform spacing (e.g., angular spacing) between various ones of the elongate members 304 may lead to varying degrees of overlap between different groups of the elongate members 304 in the distal hub region 308d and thereby lead to some degree of non-uniformity or asymmetry in the closed shape 308d-3. In some embodiments, even though the perimeter of the distal hub region 308d is non-uniform in some embodiments, e.g, due to an existence of a notch like notch 311 or other non-uniformity, a center of such a distal hub region 308d may be deemed to be a center of a shape of the distal hub region 308d in the absence of such non-uniformities or a center where the axis (e.g., axis 335a) of the structure passes. In other words, a center of a particular shape of a distal hub region 308d including a notch such as notch 311 need not correspond to a geometric center or centroid of the particular shape.

Figure 5 shows a prior art structure 508 that includes an arrangement of a plurality of elongate members 504 that is different than the arrangement of elongate members 304 arranged in structure 308. For example, Figure 5 shows a plan or polar view of a portion of the structure 508 including a distal hub 508d, the plan or polar view having an orientation similar to the orientation shown in Figure 3C. In Figure 5, a crossing location 508d-lc (two called out) is defined as a location where edges 503 (two pairs called out in Figure 5) of at least a pair (e.g., two adjacent ones) of elongate members 504 cross when viewed from a direction normal to the distal hub region 508d. It is noted that unlike the non-uniform spacing between the elongate members 304 (e.g., angular spacing between the elongate members 304 about a center of the distal hub region 308d as described in this disclosure) the uniform spacing between the elongate members 504 (e.g., angular spacing between the elongate members 504 about a center of the distal hub region 508d) results in the various crossing locations 508d-lc being radially distributed from a center of distal hub region 508d in manner that a closed shape 508d-4 produced by line segments connecting adjacent ones of the crossing locations 508d-lc has a substantially uniform or symmetrical shape (e.g., a substantially circular shape in this case).
In some embodiments, non-uniform spacing between various ones of the elongate members 304 may be motivated for different reasons. For example, the non-uniform spacing between various ones of the elongate members 304 may be employed to improve alignment or contact between at least a portion of the structure 308 and one or more preferred or targeted regions of a tissue wall of a bodily cavity (e.g., to position a more favorable distribution of the transducers 306 relative to various anatomical features in a bodily cavity into which the transducers 306 are deployed). For example, as shown in Figures 3B and 3C, a first longitudinal gap 341a exists between an adjacent pair of elongate members 304 that is wider than a second longitudinal gap 341b between an adjacent pair of elongate members 304. It is noted, in some embodiments, that each of the first longitudinal gap 341a and the second longitudinal gap 341b may be located along a same line of latitude of the plurality of lines of latitude 333 when the structure 308 is in the expanded or deployed configuration. It is noted, in some embodiments, that each of the first longitudinal gap 341a and the second longitudinal gap 341b may be located along a plane that transversely intersects first axis 335a. It is noted, in some embodiments, that the curved portions 337 of all the elongate members 304 may each extend along a respective curved path that intersects the first axis 335a at each of at least two respective spaced apart locations. It is noted, in some embodiments, that the curved portions 337 of all the elongate members 304 may each intersect the first axis at at least two respective spaced apart locations.
In some embodiments, a first longitudinal gap 341a exists between an adjacent pair of elongate members 304 that is wider than a second longitudinal gap 341b between an adjacent pair of elongate members 304 as viewed along the first axis 335a or as viewed normally to the distal hub region 308d or as viewed normally to the proximal hub region 308c. For added clarity, gaps 341a, 341b and another relatively large gap 341c are shown in Figure 3D (various elongate members 304 are shown partially sectioned away in Figure 3D to show first axis 335a).
While other embodiments implement different elongate-member-spacing arrangements than at least the embodiments of Figures 3B, 3C, and 3D, the elongate-member-spacing arrangements of the embodiments of Figures 3B, 3C, and 3D may be beneficial to facilitate proper and improved coverage around an anatomical feature of interest, such as the left-pulmonary-vein group, especially if spatial relationships between various anatomical features may not vary significantly from patient to patient. For instance, the inventors have determined that the elongate-member-spacing arrangements of the embodiments of at least Figures 3B, 3C, and 3D, especially when adopting an inverted deployment like that shown in Figure 2B (as compared to Figure 2A), improves transducer placement around the left-pulmonary-vein group, the right-pulmonary-vein group, and the left lateral ridge to more effectively treat, among other things, atrial fibrillation.
It is noted that in some embodiments, that non-uniform spacing between various ones on the elongate members 304 may create a higher spatial density of transducers in some regions of the structure 308 than in other regions of the structure 308. For example, in Figure 3C, each of regions 310a and 310c include smaller gaps between corresponding portions of adjacent elongate members 304 in those regions than the relatively larger gaps between corresponding portions of adjacent elongate members 304 in region 310b. Regions 310a and 310c have a higher number of transducers 306 /electrodes 315 per unit area of these regions than the number transducers 306 /electrodes 315 per unit area of region 310b. Higher spatial densities of the transducers 306 /electrodes 315 may allow larger selection possibilities of transducers 306 /electrodes 315 to choose particular ones of the transducers 306 /electrodes 315 that may be better positioned to interact with particular tissue at a specific location to provide more efficacious results from said interaction. Additionally, in some embodiments in which the electrodes 315 are ablation electrodes, higher spatial densities of the electrodes 315 provided by smaller gaps between corresponding portions of the elongate members 304 allow for improved confluence between the respective lesions formed by particular activated ones of the electrodes 315 to effectively block spurious electrical cardiac signals in the treatment of atrial fibrillation. It is noted that the non-uniform spacing between various ones of the elongate members 304 may, according to some embodiments, allow for a smaller device size in the delivery configuration while still allowing the various transducers 306 / electrodes 315 to be appropriately positioned when the structure 308 is in the expanded or deployed configuration since additional elongate members 304 are not employed to provide a high spatial density of the transducers 306 /
electrodes 315 throughout the structure 308. Figures 3K, 3L, and 3M each show plan or polar views of example embodiments of different configurations of non-uniform arrangements of elongate members 304 and their corresponding closed shapes 308d-4. Figures 3K, 3L, and 3M
may each be considered to provide a simplified version or quasi schematic version of an arrangement of elongate members 304 with various elongate member features similar to those shown in Figure 3C (e.g., transducers 306 / electrodes 315) removed for clarity.
To aid in understanding consequences of the beneficial configuration of the structure 308 at least according to the elongate-member-spacing arrangements of the embodiments of at least Figures 3B, 3C, and 3D, reference will be made to Figure 3E and mid-line-segments 342 of elongate members 304. Figure 3E is a plan view of a distal hemisphere of the expandable structure 308 of the medical device system of Figure 3A in a deployed or expanded configuration, according to some embodiments, the expandable structure 308 including a distal hub region 308d. In Figure 3E, three of the mid-line-segments 342 (342x, 342y, and 342z) in the distal hub region 308d are illustrated in broken lines that terminate at the perimeter 308d-3 of the distal hub region 308d. In this regard, each respective elongate member 304 includes a mid-line-segment 342 at least in the distal hub region 308d extending along the length 328 of the respective elongate member 304 and bisecting the width 323 of the respective elongate member 304 in the distal hub region 308d. In some embodiments, the width 323 may be an average width of the respective elongate member 304, at least in the distal hub region 308d, to account, for example, for notches 344 (one called out in Figure 3E) or other variations in the width of an elongate member 304. In some embodiments, the width 323 may be a maximum width of the respective elongate member 304 at least in the distal hub region 308d. In some embodiments, the width 323 may be a width of a portion of the respective elongate member 304, the portion of the respective elongate member located in a region of the distal hub region 308d in which particular portions of all the elongate members 304 overlap one another (e.g, in a front surface 318a-toward-back surface 318b configuration) as indicated in Figure 3E. In some embodiments, the width 323 is a width of a particular portion of the respective elongate member 304 that does not include a notch 344. In some embodiments, the first axis 335a may extend through a center of the distal hub region 308d. It is noted that the above definitions of mid-line-segments 342 in the distal hub region 308d also applies to mid-line-segments 342 in the proximal hub region 308c discussed in more detail below, according to some embodiments.
In some embodiments, a center of the distal hub region 308d may be defined as a location where the mid-line-segments 342 of at least two of the elongate members 304 (e.g., mid-line-segments 342x, 342z) cross (e.g., in an X configuration) when the structure 308 is in the expanded or deployed configuration. In some embodiments, the first axis 335a may extend through a center of the proximal hub region 308c. In some embodiments, a center of the proximal hub region 308c may be defined as a location where mid-line-segments 342 of at least two of the elongate members 304 cross in the proximal hub region 308c when the structure 308 is in the expanded or deployed configuration. In some embodiments, a center of the distal hub region 308d is defined as a location where mid-line-segments 342 of at least some, but not all of the elongate members 304 cross (e.g., in an X configuration) in the distal hub region 308d when the structure 308 is in the expanded or deployed configuration. In some embodiments, a center of the proximal hub region 308c may be defined as a location where mid-line-segments 342 of at least some, but not all of the elongate members 304 cross in the proximal hub region 308c when the structure 308 is in the expanded or deployed configuration.
It is noted that while an elongate member 304 may include a mid-line than spans the entire length of the elongate member 304, such elongate member 304 may include two distinct mid-line-segments 342 comprising respective portions of the mid-line, where one of the two distinct mid-line-segments 342 is in the distal hub region 308d, and the other is in the proximal hub region 308e. Figure 3F shows, according to some embodiments, a plan or polar view of a structure 308 including elongate members 304 deployed in an expanded configuration similar to the embodiments shown in Figure 3E. A non-uniform spacing between various adjacent ones of the elongate members 304 in Figure 3F is present in a manner similar to embodiments shown in Figure 3E. Also, in a manner similar to Figure 3E, each of various ones of the elongate members 304 in Figure 3F includes a respective mid-line-segment 342 (i.e., illustrated in broken-lines) (four called out as 342a, 342b, 342c, and 342d) in the distal hub region 308d. Because different embodiments of perimeters of the distal hub region 308d are illustrated in Figure 3F as perimeters 308d-4 and 308d-5, Figure 3F shows the mid-line-segments 342a, 342b, 342c, 342d terminating at the outer portions of the perimeters 308d-4, 308d-5.
However, such mid-line-segments 342a, 342b, 342c, and 342d may terminate at whichever perimeter for the distal hub region 308d is selected according to a particular embodiment. In some embodiments, Figure 3F may be considered to provide a simplified version or quasi schematic version of an arrangement of elongate members 304 with various elongate member features similar to those shown in Figure 3E removed for the ease of discussion. For clarity, notches 344 and transducers 306 / electrodes 315 are not shown in Figure 3F to better show mid-line-segments 342, but it is understood that embodiments shown in Figure 3F
may include at least some of these features or alternate features. A distal hub region 308d and a closed shape 308d-4, each of which is described above, are also shown in each of Figures 3E and 3F.
It is noted that same part numbers are used to describe the same or similar elements throughout the figures. It is understood that the similar elements need not be identical in form, but may be identical in function according to various embodiments.
In some embodiments associated with the plan or polar view of Figure 3F, the respective mid-line-segment 342 of each respective elongate member 304 crosses the respective mid-line-segment 342 of each of at least some of the other elongate members 304. In some embodiments associated with the plan or polar view of Figure 3F, the respective mid-line-segment 342 of each respective elongate member 304 crosses the respective mid-line-segment 342 of each of all the other elongate members 304. In some embodiments associated with Figure 3F, the respective mid-line-segment 342 of each respective elongate member 304 crosses the mid-line-segment 342 of a respective adjacent elongate member 304 at a respective crossing location at least in the distal hub region 308d.
In Figure 3F, the distal hub region 308d is illustrated with a circular perimeter 308d-5 for clarity, although any of the above-discussed perimeters and different dimensions of the distal hub region 308d may be selected for the benefit of particular circumstances. The same applies for Figures 3G and 3H. For example, closed shape 308d-4 (defined as described above) in Figure 3F may, in some embodiments, define a perimeter of the distal hub region 308d. When viewed from a direction normal to the distal hub region 308d, (e.g., the view shown in Figure 3F) two of the mid-line-segments 342a, 342b of two of the elongate members 304a, 304b cross the mid-line-segment 342c of a third elongate member 304c at different locations 346a, 346b when the structure 308 is in the expanded configuration. In this regard, a location (e.g., location 346a or 346b) in this context, where mid-line-segments cross each other, is intended to mean a location in a plan (two-dimensional) view, even though the mid-line-segments may not intersect in three-dimensional space, as the respective elongate members 304 may not pass through each other;
instead, they may overlap each other, for example as shown in region 347 in Figure 31. It is noted that each of the respective part number leader lines pointing to the locations 346a, 346b, and 346c (described below) as well as other various locations in other ones of the figures include terminal circular portions that encircle respective ones of locations 346a, 346b, and 346c.
As shown in Figure 3F, the various ones of the elongate members 304 (including elongate members 304a, 304b, 304c) are stacked at each of the different locations 346a, 346b, according to some embodiments. As shown in Figure 3F, various ones of the elongate members 304 (including elongate members 304a, 304b, 304c) are in an overlapping arrangement at each of the different locations 346a, 346b, according to some embodiments. In this regard, in some embodiments, portions of the third elongate member 304c and each of the two of the elongate members 304a, 304b are arranged front surface 318a-toward-back surface 318b at each of the different locations 346a, 346b when the structure 308 is in the expanded configuration.
Similarly, each of the different locations 346a, 346b overlaps a respective portion of each of two or more elongate members 304 in the distal hub region 308d when the structure 308 is in the expanded configuration, according to some embodiments. In some embodiments, the two of the mid-line-segments 342a, 342b of the two of the elongate members 304a, 304b cross each other at a location 346c, which, when viewed from the direction normal to the distal hub region 308d (e.g., the view shown in Figure 3F), does not overlap any portion of at least the third elongate member 304c within the distal hub region 308d when the structure 308 is in the expanded configuration. In various embodiments, a positioning of the various mid-line-segments 342 (e.g., mid-line-segments 342a, 342b, and 342c) described above with respect to Figure 3F may, at least in part, provide a non-uniform spacing (e.g., a non-uniform angular spacing) between various ones of the elongate members 304.

In some embodiments, when viewed along the first axis 335a or when viewed from a direction normal to the distal hub region 308d, (e.g., along the first axis 335a or the view shown in Figure 3F) two of the mid-line-segments 342b, 342c of two of the elongate members 304b, 304c cross the mid-line-segment 342a of a third elongate member 304a at different locations 346c, 346a when the structure 308 is in the expanded configuration.
In this regard, a location (e.g., location 346c or 346a) in this context, where mid-line-segments cross each other (or where elongate members 304 overlap each other), is intended to mean a crossing (or elongate member overlap) location in a plan (two-dimensional) view, even though the mid-line-segments (or elongate members thereof) do not intersect in three-dimensional space, as the respective elongate members 304 do not pass through each other in three dimensional space; instead, they overlap each other in three dimensional space according to some embodiments.
In some embodiments, when viewed from the direction normal to the distal hub region 308d, at least one (e.g., 304b) of the two of the plurality of elongate members 304b, 304c overlaps, or is overlapped by, in the distal hub region 308d, the third elongate member 304a at each of the different locations 346c, 346a when the structure 308 is in the expanded configuration.
In some embodiments, when viewed from the direction normal to the distal hub region 308d, at least one (e.g., 304c) of the two of the plurality of elongate members 304b, 304c overlaps, or is overlapped by, in the distal hub region 308d, the third elongate member 304a at one of the different locations (e.g., 346a), but not at the other of the different locations (e.g., 346c) when the structure 308 is in the expanded configuration. In some embodiments, when viewed from the direction normal to the distal hub region 308d, a first one of the different locations (e.g., 346a) overlaps a first portion of a first one of the plurality of elongate members (e.g., elongate member 304d) in the distal hub region 308d when the structure 308 is in the expanded configuration, and, when viewed from the direction normal to the distal hub region 308d, a second one of the different locations (e.g., 346c) does not overlap any portion of the first one of the plurality of elongate members (e.g., elongate member 304d) in the distal hub region 308d when the structure 308 is in the expanded configuration. In various embodiments, the first one of the plurality of elongate members (e.g., elongate member 304d) and the third elongate member (e.g., 304a) are different ones of the elongate members 304. In various embodiments, when viewed from the direction normal to the distal hub region 308d, a first one of the different locations (e.g., 346a) overlaps a first portion of a first one of the plurality of elongate members (e.g., elongate member 306d) in the distal hub region 308d when the structure 308 is in the expanded configuration, and, when viewed from the direction normal to the distal hub region 308d, a second one of the different locations (e.g., 346c) overlaps a respective portion of each of a group of at least two elongate members (e.g, elongate members 304e, 3040 of the plurality of elongate members 304 in the distal hub region 308d when the structure 308 is in the expanded configuration. In these illustrated embodiments, the group of the at least two elongate members (e.g., elongate members 304e, 3040 excludes the first one of the plurality of elongate members (e.g., elongate member 304d). In these illustrated embodiments, the group of the at least two elongate members (e.g., elongate members 304e, 3040 excludes the third elongate member (e.g., elongate member 304a).
Reference is now made to Figure 3G, which illustrates other aspects of Figure 3F, according to some embodiments. In this regard, in some embodiments, when viewed from a direction normal to the distal hub region 308d (e.g., along the first axis 335a or the view illustrated in Figure 3G) and when the structure 308 is in the expanded configuration, (a) the mid-line-segments 342c, 342d of a first sub-group of elongate members (e.g., elongate members 304c, 304d) cross each other at an on-axis (first axis 335a) location 346cd (i.e., in the middle of dotted-line circle 346cd in Figure 3G) on the first axis 335a in the distal hub region 308d, and (b) the mid-line-segments 342a, 342b of a second sub-group of elongate members (e.g., elongate members 304a, 304b) cross each other at an off-axis location 346ab (i.e., in the middle of dotted-line circle 346ab in Figure 3G) away from the first axis 335a in the distal hub region 308d. Note that Figure 30 includes a call-out 352, which illustrates a zoom-in of the area just around axis 335a. For clarity, such call-out only illustrates elongate members 304c, and 304d of the plurality of elongate members 304 of the structure 308. The mid-line-segments 342a, 342b of the second sub-group of elongate members (e.g., elongate members 304a, 304b) do not cross each other at any location on the first axis 335a in the distal hub region 308d, according to some embodiments.
When viewed from the direction normal to the distal hub region 308d, or when viewed along the first axis 335a, the off-axis location 346ab does not overlap any portion of at least a first elongate member (e.g., a first elongate member 304c or a first elongate member 304d) in the distal hub region 308d when the structure 308 is in the expanded configuration, according to some embodiments. On the other hand, when viewed from the direction normal to the distal hub region 308d, or when viewed along the first axis 335a, the on-axis location 346cd overlaps a portion of the first elongate member (e.g., a first elongate member 304c or a first elongate member 304d) when the structure 308 is in the expanded configuration, according to some embodiments. In this regard, the on-axis location 346cd overlaps not only a portion of the first elongate member (e.g., a first elongate member 304c or a first elongate member 304d) when the structure 308 is in the expanded configuration, but overlaps a respective portion of each of a group of at least two elongate members 304 in the distal hub region 308d when the structure 308 is in the expanded configuration, due at least to the stacking or layering of the elongate members 304 in the distal hub region 308d, according to some embodiments. Similarly, the off-axis location 346ab may overlap a group of elongate members 304 due to such stacking, but this group of elongate members 304 may exclude the first elongate member (e.g., a first elongate member 304c or a first elongate member 304d) in embodiments where the off-axis location 346ab does not overlap any portion of at least a first elongate member (e.g., a first elongate member 304c or a first elongate member 304d) in the distal hub region 308d when the structure 308 is in the expanded configuration.
In some embodiments, a particular elongate member 304 of the plurality of elongate members includes a first electrode 315 located, at least in part, at a center of the distal hub region (for example, electrode 315-2 shown in Figure 3J). In some embodiments, a particular elongate member 304 of the plurality of elongate members includes a first electrode 315 located in the distal hub region 308d such that the first electrode is passed through by the first axis 335a (for example, electrode 315-2 shown in Figure 3J).
In some embodiments, central electrode, like electrode 315-2 in Figure 3J, is provided in embodiments according to Figure 3G. Such a central electrode is illustrated in the call-out 352 in Figure 3G as electrode 315-3. In some of these embodiments, such central electrode 315-3 is positioned to be passed though by the first axis 335a in the distal hub region 308d. In various embodiments, the off-axis location 346ab does not overlap any portion of the first electrode 315-3 when viewed from a direction normal the distal hub region 308d (e.g., when viewed along first axis 335a). In various embodiments, the on-axis location 346cd overlaps a portion of the first electrode 315-3 when viewed from a direction normal the distal hub region 308d (e.g., when viewed along first axis 335a). It is noted that various electrodes 315 other than first electrode 315-3 may be located on various ones of the elongate members 304 shown in Figure 3G. In various embodiments, a positioning of the various mid-line-segments 342 (e.g., at least mid-line-segments 342a, 342b, 342c, and 342d) described above with respect to Figure 3G
may, at least in part, provide a non-uniform spacing (e.g., a non-uniform angular spacing) between various ones of the elongate members 304. In this regard, according to various embodiments, the mid-line-segments 342 of each of a plurality of various pairs of the elongate members 304 may cross at different locations in the distal hub region 308d, each of at least some of the different locations radially spaced from the first axis 335a, and at least some of the different locations angularly spaced about the first axis 335a.
Reference is now made to Figure 31, which illustrates other aspects of at least Figures 3F
and 3G, but from a perspective view, according to some embodiments. In this regard, it can be seen in Figure 31 that, according to some embodiments, elongate members 304 (e.g., all elongate member 304 in Figure 31) cross or overlap each other in region 347 at least proximate the distal ends 305 in the proximal hub region 308c when the structure 308 is in the expanded configuration (recall that in Figure 31, elongate member 304a has been partially sectioned away to reveal the interior of the structure 308). In addition, it can be seen in Figure 31 that, according to some embodiments, the axis 335a passes through multiple (e.g., all in Figure 31) elongate members 304 in the region 347 when the structure 308 is in the expanded configuration. In some embodiments, mid-line-segments 342 in the proximal hub region 308c (only one called out in Figure 31) of multiple (e.g., all in Figure 31) elongate members 304 cross or pass through the axis 335a in the region 347 when the structure 308 is in the expanded configuration. In some embodiments, when viewed from a direction normal to the proximal hub region 308c (e.g., along the first axis 335a), and when the structure 308 is in the expanded configuration, (a) mid-line-segments in the proximal hub region 308c of at least the above-discussed first sub-group of elongate members 304c and 304d cross each other at an on-axis location 346cd-1 (i.e., a location in plan (two-dimensional) view from the direction normal to the proximal hub region 308c) on the first axis 335a in the proximal hub region 308c, and (b) mid-line-segments in the proximal hub region 308c of the above-discussed second sub-group of elongate members elongate members 304a, 304b also cross each other at an on-axis location 346ab-1 (i.e., a location in plan (two-dimensional) view from the direction normal to the proximal hub region 308c) on the first axis 335a in the proximal hub region 308c. It is noted that the first on-axis location 346cd-1 and the second on-axis location 346ab-1 represent the same location in two-dimensional space (e.g., as viewed from the direction normal to the proximal hub region 308c or as viewed along the first axis 335a). However, as illustrated by the stacking of elongate members 304 in region 347 in Figure 31, such locations 346cd-1, 346ab-1 are separated in 3-dimensional space (for example, separated along the first axis 335a since their corresponding mid-line-segments 342 lie on different elongate members 304 that may not share a same space (e.g, as may occur in some stacked arrangements, such as that shown in Figure 31, according to some embodiments).
With respect to the distal hub region and as shown, for example, with Figure 3G, in some embodiments, when viewed from a direction normal to the distal hub region 308d or when viewed along first axis 335a, and when the structure 308 is in the expanded configuration, the mid-line-segments 342c, 342d in the distal hub region 308d of the first sub-group of elongate members (e.g., elongate members 304c, 304d) cross each other at an on-axis location 346cd on the first axis 335a in the distal hub region 308d. In some embodiments, when viewed from the direction normal to the distal hub region 308d, or when viewed along the first axis 335a, and when the structure 308 is in the expanded configuration, the mid-line-segments 342a, 342b in the distal hub region 308d of the second sub-group of elongate members (e.g, elongate members 304a, 304b) cross each other at an off-axis location 346ab away from the first axis 335a in the distal hub region 308d.
In some embodiments, the mid-line-segment crossing locations 346ab (e.g., Figure 3G), 346cd (e.g., Figure 3G), 346ab-1 (e.g., Figure 31), and 346cd-1 (e.g., Figure 31) each are offset from the second axis 335b as shown, for example, in Figure 31. Second axis 335b may be collinear with the longitudinal axis 339d of the shaft member 316 at the distal end 316b of the shaft member 316. In other words, in some embodiments, the longitudinal axis 339d of the shaft member 316 at the distal end 316b of the shaft member 316 does not pass through at least each of the particular locations 346ab (e.g., Figure 3G), 346cd (e.g., Figure 3G), 346ab-1 (e.g., Figure 31), and 346cd-1 (e.g., Figure 31), at least when the structure 308 is in the expanded configuration.
According to some embodiments, when viewed along the first axis 335a, the mid-line-segments 342 in the distal hub region 308d of a first set of two of the plurality of elongate members 304 (e.g., elongate members 304c, 304d) may cross each other (e.g., in an X
configuration) at a first location (e.g., on-axis location 346cd in Figure 3G) in the distal hub region 308d when the structure 308 is in the expanded configuration, the first location intersected by the first axis 335a. When viewed along the first axis 335a, the mid-line-segments 342 in the proximal hub region 308c of a second set of two of the plurality of elongate members (e.g., elongate members 304a, 304b) may cross each other at a second location (e.g., on-axis location 346ab-1 in Figure 31) in the proximal hub region 308c when the structure 308 is in the expanded configuration, the second location intersected by the first axis 335a.
Alternatively, according to some embodiments, the second set of the two of the plurality of elongate members 304 may be provided by elongate members 304c and 304d (i.e., the same elongate members 304 included in the first set of the two of the plurality of elongate members 304), and the mid-line-segments 342 in the proximal hub region 308c of the second set of two of the plurality of elongate members (e.g., elongate members 304c, 304d) may cross each other at a second location (e.g., on-axis location 346cd-1 in Figure 31) in the proximal hub region 308c when the structure 308 is in the expanded configuration, the second location intersected by the first axis 335a.
In some embodiments, like those shown in Figure 3B, various portions of the respective intermediate portions 309, curved portions 337, or both, of various ones of the elongate members 304 are angularly arranged with respect to one another about a first axis 335a when structure 308 is in the deployed configuration. In some embodiments, the first axis 335a is oblique with respect to an extension direction of a second axis 335b (e.g., shown at least in Figures 3B, 3D, and 31) in which a length of the shaft member 316 extends at the distal end 316b.
In some embodiments, the first axis 335a is transverse with respect to an extension direction of a second axis 335b (e.g., shown at least in Figure 3B, 3D, and 31) in which a length of the shaft member 316 extends at the distal end 316b. It is noted that elongate members 304c, 304d, and 304g in Figure 3D have been partially sectioned away (i.e., as compared with elongate member 304c, 304d, and 304g in Figure 3B) to better show first axis 335a and its relationship with various ones of the elongate members 304. It is noted that elongate member 304a in Figure 31 has been partially sectioned away (i.e., as compared with elongate member 304a in Figure 3B) to better show first axis 335a and its relationship with various ones of the elongate members 304. In this regard, the second axis 335b may be collinear with the longitudinal axis 339d of the shaft member 316 at the distal end 316b of the shaft member 316. The second axis 335b (or longitudinal axis 339d when collinear with the second axis 335b) may extend through a geometric center or centroid of the cross-section of shaft member 316. In some embodiments, the second axis 335b and the first axis 335a are not collinear axes. In some embodiments, the second axis 335b and the first axis 335a are not parallel axes. In some embodiments, the second axis 335b and the first axis 335a intersect when the structure 308 is in the expanded configuration. In some embodiments, the second axis 335b and the first axis 335a do not intersect when the structure 308 is in the expanded configuration. For example, as shown in Figure 31, the second axis 335b (or a collinear portion of the longitudinal axis 339b extending outwardly from the distal end 316b of the shaft member 316) does not intersect the first axis 335a when the structure 308 is in the expanded configuration according to some embodiments. It is noted that according to various embodiments, the second axis 335b (or a collinear portion of the longitudinal axis 339b extending outwardly from the distal end 316b of the shaft member 316) does not pass through the distal hub region 308d in Figure 31. According to some embodiments, when the structure 308 is in the expanded configuration, the first axis 335a of the structure may extend between a first location in the distal hub region 308d where the mid-line-segments 342 in the distal hub region 308d of two of the plurality of elongate members 304 cross each other (e.g., as viewed along the first axis 335a), and a second location in the proximal hub region 308c where the mid-line-segments 342 in the proximal hub region 308c of the two of the plurality of elongate members 304 cross each other (e.g., as viewed along the first axis 335a).
The first axis 335a and the second axis 335b may be oriented to not intersect each other for various reasons including imparting a lateral shift (e.g., left¨right in the view of Figure 31) between the proximal hub region 308c and the distal hub region 308d or imparting a preferred degree of asymmetry in the structure 308 in the expanded configuration, either reason being motivated by a particular anatomy of a bodily cavity into which structure 308 is deployed. The first axis 335a and the second axis 335b may be oriented to not intersect by different methods including configuring respective first portions of at least some of the elongate members 304 positioned to one side of the first axis 335a to have greater lengths than the lengths of respective second portions of at least some of the elongate members 304 positioned off to the other or opposing side of the first axis 335a. In some embodiments in which the elongate members 304 cross each other in a stacked arrangement at least in the distal hub region 308d, successive pairs of at least some of the elongate members 304 in the stacked arrangement may be configured to cross each other at different points along their respective lengths 328 (e.g., a crossing point between the successive pair of the elongate members 304 being located along the respective length 328 of a first elongate member of the successive pair from the respective distal end 305 of the first elongate member by a first amount that is different than a second amount that the crossing point is located along the respective length 328 of a second elongate member of the successive pair from the respective distal end 305 of the second elongate member) to cause, at least in part, the first axis 335a and the second axis 335b to not intersect.
A coupler (not shown, but including a tie line or cable extending through the elongate members 304 proximate an intersection location 353 of the first axis 353a in the distal hub region 308d) may be employed to assist in maintaining a position of the distal hub 308d in the expanded configuration and maintain the first and second axes 335a, 335b in a non-intersecting configuration. In some embodiments, a plurality of couplers 351 (four called out in Figure 31) may be employed, at least in part, to provide or maintain a desired angular spacing between adjacent elongate members 304 when the structure is in the expanded configuration. In some embodiments, a plurality of couplers 351 (four called out in Figure 31) may be employed, at least in part, to provide or maintain a difference in angular spacing between two elongate member 304 in the proximal hub region 308c and the distal hub region 308d as described above in this disclosure.
To further aid in understanding characteristics of the beneficial configurations of the structure 308 at least according to the elongate-member-spacing arrangements of the various embodiments of the present invention, reference is made again to Figure 3C. In this regard, it should be recalled that adjacent ones of the crossing points 308d-lc may be connected by respective line segments to form a closed shape 308d-4 that may define the perimeter or boundary of the distal hub region 308d. As shown in Figure 3C, this closed shape 308d-4 includes at least one notch 311 when viewed from a direction normal to the distal hub region 308d when the structure 308 is in the expanded configuration. The notch 311 includes a radially inward valley toward a center of the distal hub region 308d. In some embodiments, the closed shape 308d-4 may include one or more protrusions 355, each of which may include a radially outward peak that protrudes away from the center of the distal hub region 308d. For example, in Figure 3L, the closed shape 308d-4 includes a notch 311 and a protrusion 355, each arising at least in part from a particular position of the elongate members in the distal hub region 308d. For example, in Figure 3M, the closed shape 308d-4 includes a notch 311 and two protrusions 355 that include a small notch (different than notch 311) between them, such small notch representing a region where there is no overlapping of elongate members.
Reference is now made to Figure 3H, which illustrates other aspects of at least Figure 3F, according to some embodiments. When viewed from a direction normal to the distal hub region 308d (e.g., the view illustrated in Figure 3H), a first pair of edges 303c, 303f of a first pair of elongate members 304a, 304b (although the first pair of elongate members need not be adjacent according to some embodiments) cross at a first location 308d- if (i.e., the center of the dotted-line circle 308d-lf) in the distal hub region 308d when the structure 308 is in the expanded configuration, according to some embodiments. A second pair of edges 303e, 303d of the first pair of elongate members 304a, 304b cross at a second location 308d-le in the distal hub region 308d when the structure 308 is in the expanded configuration, according to some embodiments.
In this regard, the second pair of edges 303e, 303d does not include any edge of the first pair of edges 303c, 303f, according to some embodiments. The locations 308d-le and 308d-if may be located along the respective intermediate portions 309 of the first pair of elongate members 304a, 304b.
It is noted that, when viewed from the direction normal to the distal hub region 308d (e.g., along the first axis 335a or the view illustrated in Figure 3H) when the structure 308 is in the expanded configuration, the first location 308d-lf does not overlap, and is not overlapped by, a first elongate member 304f while the second location 308d-le overlaps, or is overlapped by, the first elongate member 304f, according to some embodiments. In this regard, the term "overlap" and the phrase "overlapped by" are intended to mean "within a region of' in a two-dimensional plan-view context. Further, it is noted that the first elongate member 304f is not one of the first pair of elongate members 304a, 304b according to some embodiments.
It can be seen in Figure 3H that the first location 308d-lf is a location in the distal hub region 308d that overlaps a portion of a second elongate member 304p or is a location in the distal hub region 308d that is overlapped by a portion of the second elongate member 304p, according to some embodiments. Figure 3H additionally reveals that the second location 308d-le is a location in the distal hub region 308d that overlaps a portion of a third elongate member 304g or is a location in the distal hub region 308d that is overlapped by a portion of the third elongate member 304g. It is noted that the second elongate member 304p and the third elongate member 304g are not the same elongate member 304 according to various embodiments. It can be seen in Figure 3H that the first location 308d-lf and the second location 308d-le may both, according to some embodiments, overlap a portion of one of the elongate members (e.g., elongate member 304e), or be overlapped by a portion of one of the elongate members (e.g., elongate member 304e) in the distal hub region 308d when viewed along the first axis 335a.
Also in Figure 3H, it can be seen that the first location 308d-lf does not overlap, and is not overlapped by, a first electrode 315-4 when viewed along the first axis 335a, while the second location 308d-le overlaps, or is overlapped by, the first electrode 315-4 when viewed along the first axis 335a, according to some embodiments. Note that first electrode 315-4 also is shown, for example, in Figure 3J. Also note that Figure 3H only shows electrode 315-4 for clarity, although other electrodes may be present pursuant to, for example, the other figures shown herein.
In some embodiments, when viewed from the direction normal to the distal hub region 308d (e.g., along the first axis 335a or the view illustrated in Figure 3H), a third pair of edges 303c, 303d of the first pair of elongate members 304a, 304b cross at a third location 308d-id in the distal hub region 308d when the structure 308 is in the expanded configuration. The third pair of edges 303c, 303d includes one edge 303c of the first pair of edges 303c, 303f and one edge 303d of the second pair of edges 303e, 303d.
In some embodiments, as shown in Figure 3H, outward-facing surface portions (e.g., portions of the respective front surfaces 318a) of the first pair of elongate members 304a, 304b face a same direction (e.g., an outward direction of the first axis 335a or another outward direction which may be normal to such outward-facing surface portions) when the structure 308 is in the expanded configuration. Also as shown at least in Figure 314, the outward-facing surface portion of the elongate member 304a may cross behind the outward-facing surface portion of the elongate member 304b when the outward-facing surface portion of the elongate member 304b is viewed from a direction opposite the same direction (e.g., an inward direction of the first axis 335a or another inward direction which may be normal to such outward-facing surface portion) when the structure 308 is in the expanded configuration.
While some of the embodiments disclosed above are described with examples of cardiac ablation, the same or similar embodiments may be used for ablating other bodily organs or any lumen or cavity into which the devices of the present invention may be introduced.
Subsets or combinations of various embodiments described above provide further embodiments.
These and other changes may be made to various embodiments in light of the above-detailed description. In general, in the following claims, the terms used should not be construed to limit the invention to the specific embodiments disclosed in the specification and the claims, but should be construed to include other electrode-based device systems including all medical treatment device systems and all medical diagnostic device systems in accordance with the claims. Further, it should be noted that, although several of the above-discussed embodiments are described within the context of an intra-cardiac medical device system, other embodiments apply to other medical and non-medical device systems, such as an device system in which detecting one or more improper energy transmission configurations is beneficial.
Accordingly, the invention is not limited by this disclosure, but instead its scope is to be determined entirely by the claims.

Claims (116)

WHAT IS CLAIMED IS:

1. A medical system comprising:
a structure comprising a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity; and a shaft member comprising a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end, and the shaft member comprising a length from the proximal end to the distal end, the length of the shaft member sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity, wherein each of the plurality of elongate members comprises a first end, a second end, and a length from the first end to the second end, the structure comprising a distal hub region and a proximal hub region when the structure is in the expanded configuration, the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, wherein each respective elongate member of the plurality of elongate members comprises a mid-line-segment in the distal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the distal hub region, the width perpendicular to the length, in the distal hub region, of the respective elongate member or a tangent of the length, in the distal hub region, of the respective elongate member, wherein, when viewed from a direction normal to the distal hub region, the plurality of elongate members extend across one another in the distal hub region when the structure is in the expanded configuration, and, when viewed from the direction normal to the distal hub region, two of the mid-line-segments of two of the plurality of elongate members cross the mid-line-segment of a third of the plurality of elongate members at different locations when the structure is in the expanded configuration, and wherein, when viewed from the direction normal to the distal hub region, each of the two of the plurality of elongate members overlaps or is overlapped in the distal hub region by the third of the plurality of elongate members at each of the different locations when the structure is in the expanded configuration.

2. The medical system of Claim 1, further comprising a plurality of electrodes coupled to at least some of the plurality of elongate members, the plurality of electrodes operable to be energized to interact with tissue within the bodily cavity.

3. The medical system of Claim 1, wherein the width of each respective elongate member in the distal hub region is perpendicular to and longer than a thickness of the respective elongate member in the distal hub region.

4. The medical system of Claim 1, wherein the two of the mid-line-segments of the two of the plurality of elongate members cross each other at a location that, when viewed from the direction normal to the distal hub region, does not overlap and is not overlapped by any portion of at least the third of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

5. The medical system of Claim 4, wherein, when viewed from the direction normal to the distal hub region, each of the different locations overlaps or is overlapped by a respective portion of each of two or more of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

6. The medical system of Claim 1, wherein, when viewed from the direction normal to the distal hub region, a portion of each of the plurality of elongate members overlaps or is overlapped by a portion of at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

7. The medical system of Claim 1, wherein, when viewed from the direction normal to the distal hub region, a portion of each of the plurality of elongate members overlaps or is overlapped by a portion of each of the others of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

8. The medical system of Claim 7, wherein, when viewed from the direction normal to the distal hub region, a perimeter of the distal hub region is defined, at least in part, from extremities of overlapping regions associated with the portion of each elongate member that overlaps or is overlapped by the portion of at least one other of the elongate members in the distal hub region when the structure is in the expanded configuration.

9. The medical system of Claim 1, wherein, when viewed from the direction normal to the distal hub region, a first one of the different locations overlaps or is overlapped by a first portion of a first one of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, and, when viewed from the direction normal to the distal hub region, a second one of the different locations does not overlap and is not overlapped by any portion of the first one of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

10. The medical system of Claim 1, wherein, when viewed from the direction normal to the distal hub region, a first one of the different locations overlaps or is overlapped by a first portion of a first one of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, and, when viewed from the direction normal to the distal hub region, a second one of the different locations overlaps or is overlapped by a respective portion of each of a group of at least two elongate members of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, the group of the at least two elongate members of the plurality of elongate members excluding the first one of the plurality of elongate members.

11. The medical system of Claim 10, wherein each respective portion of the group of the at least two elongate members of the plurality of elongate members is an outward-facing surface portion, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, the outward-facing surface portion of a first particular one of the group of the at least two elongate members of the plurality of elongate members and the outward-facing surface portion of a second particular one of the group of the at least two elongate members of the plurality of elongate members facing a same direction when the structure is in the expanded configuration, with the outward-facing surface portion of the first particular one crossing behind the outward-facing surface portion of the second particular one when the outward-facing surface portion of the second particular one is viewed from a direction opposite the same direction when the structure is in the expanded configuration.

12. The medical system of Claim 1, wherein each of the plurality of elongate members comprises a thickness, a front surface, and a back surface opposite across the thickness from the front surface, each front surface positionable to face away from an interior of the bodily cavity toward a tissue surface of a wall of the bodily cavity in a state in which the structure is positioned in the bodily cavity in the expanded configuration, and wherein portions of the third of the plurality of elongate members and each of the two of the plurality of elongate members at each of the different locations are arranged front surface-toward-back surface when the structure is in the expanded configuration.

13. The medical system of Claim 2, wherein a particular elongate member of the plurality of elongate members comprises a central electrode of the plurality of electrodes located, at least in part, at a center of the distal hub region, and wherein the two of the mid-line-segments of the two of the plurality of elongate members cross each other at a location in the distal hub region that, when viewed from the direction normal to the distal hub region, does not overlap and is not overlapped by any portion of the central electrode.

14. The medical system of Claim 2, wherein, when viewed from the direction normal to the distal hub region, a first one of the different locations overlaps or is overlapped by a portion of a first one of the plurality of electrodes within the distal hub region when the structure is in the expanded configuration, and, when viewed from the direction normal to the distal hub region, a second one of the different locations does not overlap and is not overlapped by any portion of the first one of the plurality of electrodes in the distal hub region when the structure is in the expanded configuration.

15. The medical system of Claim 2, wherein, when viewed from the direction normal to the distal hub region, a first one of the different locations overlaps or is overlapped by a first portion of a first one of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, and, when viewed from the direction normal to the distal hub region, a second one of the different locations overlaps or is overlapped by a respective portion of each of a group of at least two elongate members of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, the group of the at least two elongate members of the plurality of elongate members excluding the first one of the plurality of elongate members.

16. The medical system of Claim 15, wherein each respective portion of the group of the at least two elongate members of the plurality of elongate members is an outward-facing surface portion, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, the outward-facing surface portion of a first particular one of the group of the at least two elongate members of the plurality of elongate members and the outward-facing surface portion of a second particular one of the group of the at least two elongate members of the plurality of elongate members facing a same direction when the structure is in the expanded configuration, with the outward-facing surface portion of the first particular one crossing behind the outward-facing surface portion of the second particular one when the outward-facing surface portion of the second particular one is viewed from a direction opposite the same direction when the structure is in the expanded configuration.

17. The medical system of Claim 16, wherein each of the group of the at least two elongate members of the plurality of elongate members comprises an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward the interior of the structure when the structure is in the expanded configuration, and the outward-facing surface portion of the first particular one contacts the inward-facing surface portion of the second particular one when the structure is in the expanded configuration.

18. The medical system of Claim 1, wherein, in the expanded configuration, the structure encompasses a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume, and wherein each of the distal hub region and the proximal hub region comprises 1/4 of the lines of latitude.

19. The medical system of Claim 1, wherein each of the plurality of elongate members comprises a respective intermediate portion between the first end and the second end, wherein each respective intermediate portion of each of the plurality of elongate members comprises a thickness, a front surface, and a back surface opposite across the thickness from the front surface, and wherein, for each of the plurality of elongate members, the width in the distal hub region is perpendicular to and longer than the thickness in the distal hub region.

20. The medical system of Claim 1, wherein each of a plurality of crossing points is defined as a location where edges of at least a pair of elongate members of the plurality of elongate members cross when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration, and wherein, when the structure is in the expanded configuration, adjacent ones of the plurality of crossing points connected by respective line segments foun a boundary of the distal hub region.

21. The medical system of Claim 20, wherein each crossing point is defined as a location that does not overlap and is not overlapped by any elongate member of the plurality of elongate members not comprised by the respective at least the pair of elongate members of the plurality of elongate members when the structure is in the expanded configuration.

22. The medical system of Claim 20, wherein the structure, when in the delivery configuration, arranges at least part of each respective elongate member of the plurality of elongate members to be advanced with the second end of the respective elongate member ahead of the first end of the respective elongate member toward the bodily cavity.

23. The medical system of Claim 20, wherein the boundary abuts the distal hub region and the intermediate region.

24. The medical system of Claim 1, wherein a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration.

25. The medical system of Claim 1, wherein each of the plurality of elongate members comprises an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode provided at least in part on the first side, the second side, or both the first side and the second side.

26. A medical system comprising:
a structure comprising a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity; and a shaft member comprising a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end, and the shaft member comprising a length from the proximal end to the distal end, the length of the shaft member sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity, wherein each of the plurality of elongate members comprises a first end, a second end, and a length from the first end to the second end, each of the plurality of elongate members further comprising a respective intermediate portion positioned between the corresponding first and second ends, the respective intermediate portions of at least a first sub-group of the plurality of elongate members circumferentially arranged about an axis when the structure is in the expanded configuration, the structure comprising a distal hub region and a proximal hub region when the structure is in the expanded configuration, the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, wherein each respective elongate member of the plurality of elongate members comprises a mid-line-segment in the distal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the distal hub region, the width perpendicular to the length, in the distal hub region, of the respective elongate member or a tangent of the length, in the distal hub region, of the respective elongate member, and wherein, when viewed from a direction normal to the distal hub region and when the structure is in the expanded configuration, (a) the mid-line-segments of the first sub-group of the plurality of elongate members cross each other at an on-axis location on the axis in the distal hub region, and (b) the mid-line-segments of a second sub-group of the plurality of elongate members cross each other at an off-axis location away from the axis in the distal hub region.

27. The medical system of Claim 26, wherein, when viewed from the direction normal to the distal hub region and when the structure is in the expanded configuration, the mid-line-segments of the second sub-group of the plurality of elongate members do not cross each other at any location on the axis in the distal hub region.

28. The medical system of Claim 27, wherein, when viewed from a direction normal to the proximal hub region and when the structure is in the expanded configuration, mid-line-segments in the proximal hub region of the first sub-group of the plurality of elongate members cross each other at a first on-axis location on the axis in the proximal hub region.

29. The medical system of Claim 28, wherein, when viewed from the direction normal to the proximal hub region and when the structure is in the expanded configuration, mid-line-segments in the proximal hub region of the second sub-group of the plurality of elongate members cross each other at a second on-axis location on the axis in the proximal hub region.

30. The medical system of Claim 27, wherein, when viewed from a direction normal to the proximal hub region and when the structure is in the expanded configuration, mid-line-segments in the proximal hub region of the second sub-group of the plurality of elongate members cross each other at a particular on-axis location on the axis in the proximal hub region.

31. The medical system of Claim 27, wherein each of the plurality of elongate members comprises a curved portion that intersects the axis at each of a respective at least two spaced apart locations along the axis when the structure is in the expanded configuration.

32. The medical system of Claim 26, further comprising a plurality of electrodes coupled to at least some of the plurality of elongate members, the plurality of electrodes operable to be energized to interact with tissue within the bodily cavity.

33. The medical system of Claim 26, wherein the width of each respective elongate member in the distal hub region is perpendicular to and longer than a thickness of the respective elongate member in the distal hub region.

34. The medical system of Claim 26, wherein, when viewed from the direction normal to the distal hub region, the off-axis location does not overlap and is not overlapped by any portion of at least a first one of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, and wherein, when viewed from the direction normal to the distal hub region, the on-axis location overlaps or is overlapped by a portion of the first one of the plurality of elongate members when the structure is in the expanded configuration.

35. The medical system of Claim 32, wherein a particular elongate member of the plurality of elongate members comprises a first electrode of the plurality of electrodes located, at least in part, at a center of the distal hub region, wherein, when viewed from the direction normal to the distal hub region, the off-axis location does not overlap and is not overlapped by any portion of the first electrode, and wherein, when viewed from the direction normal to the distal hub region, the on-axis location overlaps or is overlapped by a portion of the first electrode when the structure is in the expanded configuration.

36. The medical system of Claim 26, wherein the structure encompasses a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume, and wherein each of the distal hub region and the proximal hub region comprises 1/4 of the lines of latitude.

37. The medical system of Claim 26, wherein each of the plurality of elongate members comprises a respective intermediate portion between the first end and the second end, wherein each respective intermediate portion of each of the plurality of elongate members comprises a thickness, a front surface, and a back surface opposite across the thickness from the front surface, and wherein, for each of the plurality of elongate members, the width is perpendicular to and longer than the thickness.

38. The medical system of Claim 35, wherein the axis passes through the first electrode when the structure is in the expanded configuration.

39. The medical system of Claim 26, wherein the axis passes through a center of the distal hub region and a center of the proximal hub region when the structure is in the expanded configuration.

40. The medical system of Claim 39, wherein the axis is oblique with respect to an extension direction in which a length of the shaft member extends at the distal end of the shaft member.

41. The medical system of Claim 26, wherein the direction normal to the distal hub region is parallel to the axis.

42. The medical system of Claim 26, wherein, when viewed from the direction normal to the distal hub region, a portion of each of the plurality of elongate members overlaps or is overlapped by a portion of at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

43. The medical system of Claim 42, wherein, when viewed from the direction normal to the distal hub region, a perimeter of the distal hub region is defined, at least in part, from extremities of overlapping regions associated with the portion of each of the plurality of elongate members that overlaps or is overlapped by the portion of the at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

44. The medical system of Claim 26, wherein each of the plurality of elongate members comprises an outward-facing surface portion at least in the distal hub region, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, and wherein each of the plurality of elongate members comprises an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward the interior of the structure when the structure is in the expanded configuration, and wherein at least (i) the outward-facing surface portion of a first particular one of the first sub-group of the plurality of elongate members contacts the inward-facing surface portion of a second particular one of the first sub-group of the plurality of elongate members when the structure is in the expanded configuration, or (ii) the outward-facing surface portion of a first particular one of the second sub-group of the plurality of elongate members contacts the inward-facing surface portion of a second particular one of the second sub-group of the plurality of elongate members when the structure is in the expanded configuration.

45. The medical system of Claim 26, wherein each of a plurality of crossing points is defined as a location where edges of at least a pair of elongate members of the plurality of elongate members cross when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration, and wherein, when the structure is in the expanded configuration, adjacent ones of the plurality of crossing points connected by respective line segments form a boundary of the distal hub region.

46. The medical system of Claim 45, wherein each crossing point is defined as a location that does not overlap and is not overlapped by any elongate member of the plurality of elongate members not comprised by the respective at least the pair of elongate members of the plurality of elongate members when the structure is in the expanded configuration.

47. The medical system of Claim 45, wherein the structure, when in the delivery configuration, arranges at least part of each respective elongate member of the plurality of elongate members to be advanced with the second end of the respective elongate member ahead of the first end of the respective elongate member toward the bodily cavity.

48. The medical system of Claim 45, wherein the boundary abuts the distal hub region and the intermediate region.

49. The medical system of Claim 26, wherein a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration.

50. The medical system of Claim 26, wherein each of the plurality of elongate members comprises an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode provided at least in part on the first side, the second side, or both the first side and the second side.

51. A medical system comprising:
a structure comprising a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity; and a shaft member comprising a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end, and the shaft member comprising a length from the proximal end to the distal end, the length of the shaft member sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity, wherein each of the plurality of elongate members comprises a first end, a second end, and a length from the first end to the second end, wherein the structure, when in the delivery configuration, arranges at least part of each respective elongate member of the plurality of elongate members to be advanced with the second end of the respective elongate member ahead of the first end of the respective elongate member toward the bodily cavity, wherein the structure comprises a distal hub region when the structure is in the expanded configuration, the plurality of elongate members converging at least in the distal hub region when the structure is in the expanded configuration, and the structure coupled to the shaft member at a region of the structure other than the distal hub region at least when the structure is in the expanded configuration, wherein, when viewed from a direction normal to the distal hub region, crossing portions of the plurality of elongate members extend across one another in the distal hub region when the structure is in the expanded configuration, wherein each of a plurality of crossing points is defined as a location where edges of a respective at least two elongate members of the plurality of elongate members cross in the distal hub region when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration, and wherein the plurality of crossing points, when adjacent ones thereof are connected by respective line segments, form a closed shape comprising at least one notch when viewed from a direction normal to the distal hub region when the structure is in the expanded configuration.

52. The medical system of Claim 51, wherein each of the plurality of elongate members comprises a respective portion radially spaced from an axis when the structure is in the expanded configuration, the respective portions of the plurality of elongate members circumferentially arranged about the axis when the structure is in the expanded configuration, and wherein the structure comprises a dimension transverse the axis, the dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration.

53. The medical system of Claim 51, wherein the structure comprises a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, and wherein the intermediate region comprises a dimension transverse to an axis extending between a center of the distal hub region and a center of the proximal hub region, the dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration.

54. The medical system of Claim 51, wherein neither the first end nor the second end of each elongate member of the plurality of elongate members resides in the distal hub region when the structure is in the expanded configuration.

55. The medical system of Claim 51, wherein the structure comprises a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, and wherein at least the second end of each elongate member of the plurality of elongate members resides in the proximal hub region.

56. The medical system of Claim 51, wherein the structure comprises a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration.

57. The medical system of Claim 51, wherein the plurality of elongate members includes all elongate members that comprise electrodes and extend across one another in the distal hub region.

58. The medical system of Claim 51, wherein, when viewed from the direction normal to the distal hub region, a portion of each of the plurality of elongate members overlaps or is overlapped by a portion of at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

59. The medical system of Claim 58, wherein, when viewed from the direction normal to the distal hub region, a perimeter of the distal hub region is defined, at least in part, from extremities of overlapping regions associated with the portion of each of the plurality of elongate members that overlaps or is overlapped by the portion of the at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

60. The medical system of Claim 51, wherein each location where edges of the respective at least two elongate members of the plurality of elongate members cross in the distal hub region when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration is a location that does not overlap and is not overlapped by any elongate member of the plurality of elongate members not comprised by the respective at least two elongate members of the plurality of elongate members when the structure is in the expanded configuration.

61. The medical system of Claim 51, wherein each of the plurality of crossing points is defined as a location where edges of two adjacent ones of the elongate members of the plurality of elongate members cross in the distal hub region when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration.

62. The medical system of Claim 51, wherein each elongate member of the plurality of elongate members comprises an outward-facing surface portion at least in the distal hub region, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, the outward-facing surface portion of a first particular elongate member of the plurality of elongate members and the outward-facing surface portion of a second particular elongate member of the plurality of elongate members facing a same direction when the structure is in the expanded configuration, with the outward-facing surface portion of the first particular elongate member crossing behind the outward-facing surface portion of the second particular elongate member when the outward-facing surface portion of the second particular member is viewed from a direction opposite the same direction when the structure is in the expanded configuration.

63. The medical system of Claim 62, wherein each elongate member of the plurality of elongate members comprises an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward the interior of the structure when the structure is in the expanded configuration, and the outward-facing surface portion of the first particular elongate member contacts the inward-facing surface portion of the second particular elongate member when the structure is in the expanded configuration.

64. The medical system of Claim 51, wherein the structure comprises a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, and wherein, in the expanded configuration, the structure encompasses a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume, and wherein each of the distal hub region and the proximal hub region comprises 1/4 of the lines of latitude.

65. The medical system of Claim 51, wherein each of the plurality of elongate members comprises a respective intermediate portion between the first end and the second end, wherein each respective intermediate portion of each of the plurality of elongate members comprises a width, a thickness, a front surface, and a back surface opposite across the thickness from the front surface, and wherein, for each of the plurality of elongate members, the width is perpendicular to and longer than the thickness.

66. The medical system of Claim 51, wherein, when the structure is in the expanded configuration, the closed shape forms a boundary of the distal hub region.

67. The medical system of Claim 51, wherein a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration.

68. The medical system of Claim 51, wherein each of the plurality of elongate members comprises an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode provided at least in part on the first side, the second side, or both the first side and the second side.

69. The medical system of Claim 51, wherein the at least one notch is a single notch.

70. A medical system comprising:
a structure comprising a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity; and a shaft member comprising a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end, and the shaft member comprising a length from the proximal end to the distal end, the length of the shaft member sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity, wherein each of the plurality of elongate members comprises a first end, a second end, and a length from the first end to the second end, the structure comprising a distal hub region when the structure is in the expanded configuration, the plurality of elongate members converging at least in the distal hub region when the structure is in the expanded configuration, and the structure coupled to the shaft member at a region of the structure other than the distal hub region at least when the structure is in the expanded configuration, wherein, when viewed from a direction normal to the distal hub region, a first pair of edges of a first pair of elongate members of the plurality of elongate members cross at a first location in the distal hub region when the structure is in the expanded configuration, wherein, when viewed from the direction normal to the distal hub region, a second pair of edges of the first pair of elongate members cross at a second location in the distal hub region when the structure is in the expanded configuration, the second pair of edges of the first pair of elongate members not including any edge of the first pair of edges of the first pair of elongate members, wherein, when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration, the first location does not overlap, and is not overlapped by, a first elongate member of the plurality of elongate members while the second location overlaps, or is overlapped by, the first elongate member, the first elongate member not comprised by the first pair of elongate members.

71.
The medical system of Claim 70, wherein neither the first end nor the second end of each elongate member of the plurality of elongate members reside in the distal hub region when the structure is in the expanded configuration.

72. The medical system of Claim 70, wherein each of the plurality of elongate members is arranged to be percutaneously deliverable second end-first to the bodily cavity when the structure is in the delivery configuration, and wherein the structure comprises a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, and wherein at least the second end of each elongate member of the plurality of elongate members reside in the proximal hub region.

73. The medical system of Claim 70, wherein each of the plurality of elongate members comprises a respective portion radially spaced from an axis when the structure is in the expanded configuration, the respective portions of the plurality of elongate members circumferentially arranged about the axis when the structure is in the expanded configuration, and wherein the structure comprises a particular dimension transverse the axis, the particular dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration.

74. The medical system of Claim 70, wherein the structure comprises a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, and wherein the intermediate region comprises a particular dimension transverse to an axis extending between a center of the distal hub region and a center of the proximal hub, the particular dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration.

75. The medical system of Claim 70, further comprising a plurality of electrodes coupled to at least some of the plurality of elongate members, the plurality of electrodes operable to be energized to interact with tissue within the bodily cavity, and wherein when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration, the first location does not overlap, and is not overlapped by, a first electrode of the plurality of electrodes while the second location overlaps, or is overlapped by, the first electrode of the plurality of electrodes.

76. The medical system of Claim 70, wherein the plurality of elongate members include all elongate members that comprise electrodes and extend across one another in the distal hub region.

77. The medical system of Claim 70, wherein, when viewed from the direction normal to the distal hub region, a portion of each of the plurality of elongate members overlaps or is overlapped by a portion of at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

78. The medical system of Claim 77, wherein, when viewed from the direction normal to the distal hub region, a perimeter of the distal hub region is defined, at least in part, from extremities of overlapping regions associated with the portion of each of the plurality of elongate members that overlaps or is overlapped by the portion of the at least one other of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

79. The medical system of Claim 70, wherein, when viewed from the direction normal to the distal hub region when the structure is in the expanded configuration, the first location is a location in the distal hub region that overlaps or is overlapped by a portion of a second elongate member of the plurality of elongate members, the second elongate member other than the first elongate member.

80. The medical system of Claim 79, wherein, when viewed from the direction nounal to the distal hub region when the structure is in the expanded configuration, the second location is a location in the distal hub region that overlaps or is overlapped by a portion of a third elongate member of the plurality of elongate members.

81. The medical system of Claim 70, wherein each elongate member of the first pair of elongate members of the plurality of elongate members comprises an outward-facing surface portion, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, wherein:
the outward-facing surface portions of the first pair of elongate members face a same first direction when the structure is in the expanded configuration, with the outward-facing surface portion of a first particular elongate member of the first pair of elongate members crossing behind the outward-facing surface portion of a second particular elongate member of the first pair of elongate members when the outward-facing surface portion of the second particular elongate member is viewed from a direction opposite the same first direction when the structure is in the expanded configuration.

82. The medical system of Claim 70, wherein the structure comprises a proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, and the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, and wherein, in the expanded configuration, the structure encompasses a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume, and wherein each of the distal hub region and the proximal hub region comprises 1/4 of the lines of latitude.

83. The medical system of Claim 70, wherein a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration.

84. The medical system of Claim 70, wherein each of the plurality of elongate members is arranged to be percutaneously deliverable second end-first to the bodily cavity when the structure is in the delivery configuration.

85. The medical system of Claim 70, wherein each of the plurality of elongate members comprises an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode provided at least in part on the first side, the second side, or both the first side and the second side.

86. A medical system comprising:
a structure comprising a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity; and a shaft member comprising a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end, and the shaft member comprising a length from the proximal end to the distal end, the length of the shaft member sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity, wherein each of the plurality of elongate members comprises a first end, a second end, and a length from the first end to the second end, the structure comprising a distal hub region and a proximal hub region when the structure is in the expanded configuration, the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, wherein each of the plurality of elongate members comprises an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode provided at least in part on the first side, the second side, or both the first side and the second side, wherein a longitudinal axis of the shaft member extends through a center of a cross-section of the shaft member between the proximal and the distal ends of the shaft member, wherein the plurality of elongate members meet at the distal hub region at least when the structure is in the expanded configuration, wherein the plurality of elongate members meet at the proximal hub region at least when the structure is in the expanded configuration, wherein an axis of the structure extends through a center of the distal hub region and a center of the proximal hub region when the structure is in the expanded configuration, and wherein, at least when the structure is in the expanded configuration, a portion of the longitudinal axis extending outwardly from the distal end of the shaft member does not intersect the axis of the structure and, wherein the portion of the longitudinal axis does not pass through at least the distal hub region at least when the structure is in the expanded configuration.

87. The medical system of Claim 86, wherein, when the structure is in the expanded configuration, each respective elongate member of the plurality of elongate members comprises a mid-line-segment in the distal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the distal hub region, the width perpendicular to the length, in the distal hub region, of the respective elongate member or a tangent of the length, in the distal hub region, of the respective elongate member, and wherein, when viewed along the axis of the structure, the mid-line-segments in the distal hub region of a first set of two of the plurality of elongate members cross each other at a first location in the distal hub region when the structure is in the expanded configuration, the first location intersected by the axis of the structure.

88. The medical system of Claim 87, wherein, when the structure is in the expanded configuration, each respective elongate member of the plurality of elongate members comprises a mid-line-segment in the proximal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the proximal hub region, the width perpendicular to the length, in the proximal hub region, of the respective elongate member or a tangent of the length, in the proximal hub region, of the respective elongate member, and wherein, when viewed along the axis of the structure, the mid-line-segments in the proximal hub region of a second set of two of the plurality of elongate members cross each other at a second location in the proximal hub region when the structure is in the expanded configuration, the second location intersected by the axis of the structure.

89. The medical system of Claim 88, wherein the first set of two of the plurality of elongate members comprises the second set of two of the plurality of elongate members.

90. The medical system of Claim 86, wherein, when the structure is in the expanded configuration, each respective elongate member of the plurality of elongate members comprises a mid-line-segment in the proximal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the proximal hub region, the width perpendicular to the length, in the proximal hub region, of the respective elongate member or a tangent of the length, in the proximal hub region, of the respective elongate member, and wherein, when viewed along the axis of the structure, the mid-line-segments in the proximal hub region of a set of two of the plurality of elongate members cross each other at a particular location in the proximal hub region when the structure is in the expanded configuration, and wherein the portion of the longitudinal axis does not pass though the particular location at least when the structure is in the expanded configuration.

91. The medical system of Claim 86, wherein each of the plurality of elongate members comprises a respective portion radially spaced from the axis of the structure when the structure is in the expanded configuration, the respective portions of the plurality of elongate members circumferentially arranged about the axis of the structure when the structure is in the expanded configuration, and wherein the structure comprises a dimension transverse the axis of the structure, the dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration.

92. The medical system of Claim 86, wherein the intermediate region comprises a dimension transverse to the axis of the structure, the dimension varying in magnitude during a movement of the structure between the delivery configuration and the expanded configuration with the dimension having a peak in magnitude when the structure is in the expanded configuration.

93. The medical system of Claim 86, wherein neither the first end nor the second end of each elongate member of the plurality of elongate members resides in the distal hub region when the structure is in the expanded configuration.

94. The medical system of Claim 86, wherein at least the second end of each elongate member of the plurality of elongate members resides in the proximal hub region.

95. The medical system of Claim 86, wherein when viewed along the axis of the structure, (i) each elongate member of the plurality of elongate members in the distal hub region is crossed by another elongate member of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, or (ii) each elongate member of the plurality of elongate members in the distal hub region crosses another elongate member of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

96. The medical system of Claim 95, wherein when viewed along the axis of the structure, (iii) each elongate member of the plurality of elongate members in the proximal hub region is crossed by another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration, or (iv) each elongate member of the plurality of elongate members in the proximal hub region crosses another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration.

97. The medical system of Claim 86, wherein when viewed along the axis of the structure, (i) each elongate member of the plurality of elongate members in the proximal hub region is crossed by another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration, or (ii) each elongate member of the plurality of elongate members in the proximal hub region crosses another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration.

98. The medical system of Claim 86, wherein when viewed along the axis of the structure, (i) each elongate member of the plurality of elongate members in the distal hub region is overlapped by another elongate member of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration, or (ii) each elongate member of the plurality of elongate members in the distal hub region overlaps another elongate member of the plurality of elongate members in the distal hub region when the structure is in the expanded configuration.

99. The medical system of Claim 98, wherein when viewed along the axis of the structure, (iii) each elongate member of the plurality of elongate members in the proximal hub region is overlapped by another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration, or (iv) each elongate member of the plurality of elongate members in the proximal hub region overlaps another elongate member of the plurality of elongate members in the proximal hub region when the structure is in the expanded configuration.

100. The medical system of Claim 86, wherein, when viewed along the axis of the structure, a perimeter of the distal hub region is defined, at least in part, from extremities of overlapping regions associated with a portion of each elongate member that overlaps or is overlapped by a portion of at least one other of the elongate members in the distal hub region when the structure is in the expanded configuration.

101. The medical system of Claim 86, wherein each elongate member of the plurality of elongate members comprises an outward-facing surface portion at least in the distal hub region, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, the outward-facing surface portion of a first particular elongate member of the plurality of elongate members and the outward-facing surface portion of a second particular elongate member of the plurality of elongate members facing a same direction when the structure is in the expanded configuration, with the outward-facing surface portion of the first particular elongate member crossing behind the outward-facing surface portion of the second particular elongate member when the outward-facing surface portion of the second particular member is viewed from a direction opposite the same direction when the structure is in the expanded configuration.

102. The medical system of Claim 101, wherein each elongate member of the plurality of elongate members comprises an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward the interior of the structure when the structure is in the expanded configuration, and the outward-facing surface portion of the first particular elongate member contacts the inward-facing surface portion of the second particular elongate member when the structure is in the expanded configuration.

103. The medical system of Claim 86, wherein, in the expanded configuration, the structure encompasses a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume, and wherein each of the distal hub region, and the proximal hub region comprises 1/4 of the lines of latitude.

104. The medical system of Claim 86, wherein each of the plurality of elongate members comprises a respective intermediate portion between the first end and the second end, wherein each respective intermediate portion of each of the plurality of elongate members comprises a width, a thickness, a front surface, and a back surface opposite across the thickness from the front surface, and wherein, for each of the plurality of elongate members, the width is perpendicular to and longer than the thickness.

105. The medical system of Claim 86, wherein a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration.

106. The medical system of Claim 86, wherein each of the plurality of elongate members is arranged to be percutaneously deliverable second end-first to the bodily cavity when the structure is in the delivery configuration.

107. A medical system comprising:
a structure comprising a plurality of elongate members, the structure selectively moveable between a delivery configuration in which the structure is sized for percutaneous delivery at least partially through a bodily opening to a bodily cavity and an expanded configuration in which the structure is sized too large for the percutaneous delivery to the bodily cavity; and a shaft member comprising a proximal end and a distal end, the structure coupled to the shaft member at least proximate the distal end, and the shaft member comprising a length from the proximal end to the distal end, the length of the shaft member sufficient to position the proximal end outside a body comprising the bodily cavity during a state in which the structure is positioned in the bodily cavity, wherein each of the plurality of elongate members comprises a first end, a second end, and a length from the first end to the second end, the structure comprising a distal hub region and a proximal hub region when the structure is in the expanded configuration, the plurality of elongate members converging in each of the distal hub region and the proximal hub region and diverging toward an intermediate region located between the distal hub region and the proximal hub region when the structure is in the expanded configuration, the distal hub region located further from the distal end of the shaft member than the proximal hub region at least when the structure is in the expanded configuration, wherein each of the plurality of elongate members comprises an electrode, a first side, a second side, and a thickness, the second side opposite across the thickness from the first side, and the electrode provided at least in part on the first side, the second side, or both the first side and the second side, wherein a longitudinal axis of the shaft member extends through a center of a cross-section of the shaft member between the proximal and the distal ends of the shaft member, wherein each respective elongate member of the plurality of elongate members comprises a mid-line-segment in the distal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the distal hub region, the width perpendicular to the length, in the distal hub region, of the respective elongate member or a tangent of the length, in the distal hub region, of the respective elongate member, wherein each respective elongate member of the plurality of elongate members comprises a mid-line-segment in the proximal hub region extending along a direction of the length of the respective elongate member and bisecting a width of the respective elongate member in the proximal hub region, the width perpendicular to the length, in the proximal hub region, of the respective elongate member or a tangent of the length, in the proximal hub region, of the respective elongate member, wherein an axis of the structure extends between a first location in the distal hub region and a second location in the proximal hub region when the structure is in the expanded configuration, wherein, when viewed along the axis of the structure, the mid-line-segments in the distal hub region of two of the plurality of elongate members cross each other at the first location in the distal hub region when the structure is in the expanded configuration, wherein, when viewed along the axis of the structure, the mid-line-segments in the proximal hub region of the two of the plurality of elongate members cross each other at the second location in the proximal hub region when the structure is in the expanded configuration, and wherein, at least when the structure is in the expanded configuration, a portion of the longitudinal axis extending outwardly from the distal end of the shaft member does not intersect the axis of the structure, and wherein the portion of the longitudinal axis does not pass through each of the first location and the second location when the structure is in the expanded configuration.

108. The medical system of Claim 107, wherein each of the plurality of elongate members comprises a respective portion radially spaced from the axis of the structure when the structure is in the expanded configuration, the respective portions of the plurality of elongate members circumferentially arranged about the axis of the structure when the structure is in the expanded configuration, and wherein the structure comprises a dimension transverse the axis of the structure, the dimension increasing in magnitude during a movement of the structure from the delivery configuration toward the expanded configuration.

109. The medical system of Claim 107, wherein the intermediate region comprises a dimension transverse to the axis of the structure, the dimension varying in magnitude during a movement of the structure between the delivery configuration and the expanded configuration with the dimension having a peak in magnitude when the structure is in the expanded configuration.

110. The medical system of Claim 107, wherein neither the first end nor the second end of each elongate member of the plurality of elongate members resides in the distal hub region when the structure is in the expanded configuration.

111. The medical system of Claim 107, wherein at least the second end of each elongate member of the plurality of elongate members resides in the proximal hub region.

112. The medical system of Claim 107, wherein each elongate member of the plurality of elongate members comprises an outward-facing surface portion at least in the distal hub region, each outward-facing surface portion positionable to face away from an interior of the structure when the structure is in the expanded configuration, the outward-facing surface portion of a first particular elongate member of the plurality of elongate members and the outward-facing surface portion of a second particular elongate member of the plurality of elongate members facing a same direction when the structure is in the expanded configuration, with the outward-facing surface portion of the first particular elongate member crossing behind the outward-facing surface portion of the second particular elongate member when the outward-facing surface portion of the second particular member is viewed from a direction opposite the same direction when the structure is in the expanded configuration.

113. The medical system of Claim 112, wherein each elongate member of the plurality of elongate members comprises an inward-facing surface portion opposite the respective outward-facing surface portion, each inward-facing surface portion positionable to face toward the interior of the structure when the structure is in the expanded configuration, and the outward-facing surface portion of the first particular elongate member contacts the inward-facing surface portion of the second particular elongate member when the structure is in the expanded configuration.

114. The medical system of Claim 107, wherein, in the expanded configuration, the structure encompasses a volume dividable by a plurality of lines of latitude separated by equal distance along an exterior surface of the volume, and wherein each of the distal hub region, and the proximal hub region comprises 1/4 of the lines of latitude.

115. The medical system of Claim 107, wherein a boundary of the distal hub region is defined where overlapping of elongate members of the plurality of elongate members ceases when the structure is in the expanded configuration.

116. The medical system of Claim 107, wherein each of the plurality of elongate members is arranged to be percutaneously deliverable second end-first to the bodily cavity when the structure is in the delivery configuration.