Devices and methods for placing electrodes in body cavities

Abstract

A device and method for placing electrodes within a body cavity is provided. An electrical sensing / stimulation device for positioning at least one electrode within body tissue is provided. The electrical sensing / stimulation device may include an elongate lead body having at least one internal lumen, at least one sensing / stimulation electrode, a deployable / retractable displacement member for moving or biasing the at least one electrode toward a user-defined direction, a tissue attachment mechanism for affixing a distal section of the device to body tissue, and an atraumatic distal lead body termination. In the retracted configuration, the attachment mechanism is positioned substantially within the distal section of the lead body, and in the deployed configuration, the attachment mechanism extends from the axis of the lead body to engage body tissue.

Description

Technical Field

[0001] (Cross - reference to Related Applications) This application claims the benefit of U.S. Provisional Application No. 61 / 990,998, filed on May 9, 2014 (Attorney Docket No. 44633 - 704.101), which is hereby incorporated by reference in its entirety.

[0002] This application is related to U.S. Patent Application No. 13 / 219,874, filed on August 29, 2011, entitled "Device and Method for Positioning an Electrode in Tissue", U.S. Provisional Patent Application No. 61 / 387,185, filed on September 28, 2010, entitled "Rhythm Support Device 2", U.S. Provisional Patent Application No. 61 / 412,992, filed on November 12, 2010, entitled "Pacing Device", U.S. Provisional Patent Application No. 61 / 420,060, filed on December 6, 2010, entitled "Pacing Device", U.S. Provisional Patent Application No. 61 / 427,306, filed on December 27, 2010, entitled "Rhythm Support Device 5", U.S. Provisional Patent Application No. 61 / 445,992, filed on February 23, 2011, entitled "Pacing Device", and U.S. Provisional Patent Application No. 61 / 501,450, filed on June 27, 2011, entitled "Pacing Device". The entire disclosure of each of these applications is hereby incorporated by reference in its entirety.

[0003] The present disclosure generally relates to sensing / stimulating electrode devices and methods for their use, and more specifically to novel devices and methods for the safer and more reliable positioning of sensing / stimulating electrodes within body tissue.

Background Art

[0004] Bradycardia (a reduced heart rate) is a common condition affecting hundreds of patients each year. Many such patients require the implantation of a permanent pacemaker device to help regulate their heart rate, while others experience bradycardia with treatable causes that do not require permanent pacemaker implantation and instead may accept temporary bradycardia support, such as for periods of less than a week. Common treatments for temporary bradycardia support involve systems that include transvenous electrode pacing leads inserted directly into the right ventricle of the heart to stimulate and regulate cardiac function. However, conventional versions of these systems have several drawbacks.

[0005] Therefore, the field of electrode stimulation devices needs new and useful devices and methods for positioning electrodes within tissue. [Overview of the Initiative] [Means for solving the problem]

[0006] This disclosure provides novel and useful devices and methods for positioning electrodes within tissue.

[0007] Embodiments of the present disclosure provide an electrical sensing / stimulator for positioning at least one electrode within body tissue. The electrical sensing / stimulator may comprise an extendable lead wire body having at least one internal lumen, at least one sensing / stimulating electrode, a deployable / retractable displacement member for moving or biasing at least one electrode and / or at least one tissue attachment member in a direction specified by the user, a tissue attachment mechanism for attaching the distal portion of the device to body tissue, and a non-traumatic distal lead wire body end. The tissue attachment mechanism may have a retracted configuration and an extended configuration. In the retracted configuration, the mechanism may be substantially located within the distal portion of the lead wire body, and in the extended configuration, the mechanism may extend from the axis of the extendable lead wire body to engage with body tissue.

[0008] Embodiments of the present disclosure provide a method for positioning an electrically sensing / stimulating device within body tissue. The method may include the steps of: navigating an extendable lead wire body to target tissue (the extendable lead wire body may comprise at least one internal lumen, sensing / stimulating electrodes, a displacement member, a tissue attachment member, a tissue attachment deployment port, and a non-traumatic distal tip); aligning the tissue attachment member to target tissue by using bidirectional torque control of the lead wire; deploying and / or extending the displacement member to bias the lead wire body, the tissue attachment member deployment port, and the electrodes toward the target tissue; operating the tissue attachment member to extend into the target tissue from the tissue anchor deployment port in order to attach the extendable lead wire body and electrodes to the target body tissue; verifying proper attachment of the device to the target; retracting and / or crushing the displacement mechanism; and retracting the tissue attachment member after attachment to the target tissue in order to release the distal lead wire body and electrodes from attachment to the target body tissue.

[0009] Aspects of this disclosure provide an electrical sensing / stimulator for positioning at least one electrode within body tissue. The electrical sensing / stimulator may comprise an extendable lead wire body, at least one sensing / stimulating electrode, a deployable / retractable displacement member, and a tissue attachment mechanism. The extendable lead wire body may have a longitudinal axis. The sensing / stimulating electrode may be connected to the extendable lead wire body. The deployable / retractable displacement member may be connected to the extendable lead wire body and may be adapted to move or bias at least one electrode in a direction specified by the user. The tissue attachment mechanism may be adapted to attach the distal portion of the extendable lead wire body to body tissue. The tissue attachment mechanism may have a retracted configuration and a deployed configuration. In the retracted configuration, the tissue attachment mechanism may be substantially positioned within at least one internal lumen. In the deployed configuration, the tissue attachment mechanism may extend from the longitudinal axis of the extendable lead wire body to engage with body tissue. The tissue attachment mechanism may comprise a plurality of tissue attachment members adapted to extend from a common port of the extension lead wire body. Two or more of the plurality of tissue attachment members may be adapted to branch from one another when extending from the common port.

[0010] The extension lead wire body may have one or more ports through which an organizing attachment mechanism is configured to unfold. The proximal portion of the extension lead wire body may be configured to connect to an external generator. The proximal portion of the extension lead wire body may be configured to connect to an external generator through a magnetic coupler. The proximal portion of the extension lead wire body may be configured to connect to an external generator through an expansion coupler adapted to extend or retract axially.

[0011] The sensing / stimulating electrode may be mounted covering the outer surface of the distal portion of the extendable lead wire body, or embedded inside it, such that a portion of the electrode may be exposed on the outer surface of the extendable lead wire body. At least one sensing / stimulating electrode comprises a first electrode and a second electrode. The first and second electrodes may be axially separated from each other. A deployable / retractable displacement member may be positioned between the first and second electrodes.

[0012] The deployable / retractable displacement member may include an expandable member having a crushing configuration and an expansion configuration. The expandable member may be adapted to unfold outward from the outside of the extension lead wire body. In some embodiments, the expandable member in the crushing configuration does not extend from the outer surface of the extension lead wire body. The expandable member in the crushing configuration may have an outer circumference larger than the outer circumference of the extension lead wire body. The expandable member may be at least partially folded in the crushing configuration. The expandable member in the crushing configuration may have a C-shaped, E-shaped, spiral, meandering, or star-shaped cross-section.

[0013] The electrical sensing / stimulator may further include a radiopaque marker mounted on the outer surface of an expandable member. The radiopaque marker may be expandable in conjunction with the expandable marker. The expandable element may be inflatable. The extension lead wire body may have an expansion lumen to provide an expansion medium for expanding the expandable element.

[0014] The expandable elements may include a mallet or an expandable cage.

[0015] The expandable elements in the expandable configuration may be molded to fit cavities in body organs or spaces. Body organs or spaces may be, but are not limited to, at least parts of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, arteries, veins, bladder, ureters, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum.

[0016] In the deployed configuration, the tissue attachment mechanism may extend from the longitudinal axis of the extension lead wire body so as to penetrate the body tissue.

[0017] Multiple tissue attachment members may be fitted to extend from the longitudinal axis of the extension lead wire body. One or more of the multiple tissue attachment members may have a curved loop. Two or more of the multiple tissue attachment members may be configured to extend from different ports of the extension lead wire body. Two or more of the multiple tissue attachment members may be fitted to be coplanar when extended.

[0018] The common port may have a length that allows the extension lead wire body to move in parallel over the linear portion of one or more of the tissue attachment members. One or more of the tissue attachment members may have a distal wire loop and the distal linear outermost portion of the distal wire loop.

[0019] Two or more of the structural mounting members branch off from each other at angles less than or equal to 270 degrees, less than or equal to 180 degrees, or less than or equal to 90 degrees, to give a few examples.

[0020] The tissue attachment member may comprise a hollow needle having an inner lumen through which one or more attachment elements are advanced when at least one tissue attachment member is deployed.

[0021] The electrical sensing / stimulating device may further include a non-traumatic distal lead wire body termination. The distal end of the extension lead wire body may include a non-traumatic distal lead wire body termination. The non-traumatic distal lead wire body termination may include a sensing / stimulating electrode. The non-traumatic distal lead wire body termination may have, to name a few, a rounded, cobra head, curved, bilaterally eccentric, or quadruple eccentric tip. The non-traumatic distal lead wire body termination may include multiple radially extending outward-facing tines.

[0022] The electrical sensing / stimulator may further include a proximal handle connected to an extendable lead wire body. The proximal handle may include one or more controls for activating at least one sensing / stimulating electrode, deploying or retracting a deployable / retractable displacement member, or deploying or retracting a tissue attachment mechanism, or one or more thereof. The proximal handle may include one or more displays for indicating the relative position of the tissue attachment mechanism, the sensed resistance of the tissue engaged by the tissue attachment mechanism, or the amount of sensed current passing through the tissue engaged by the tissue attachment mechanism, or one or more thereof.

[0023] The extension lead wire body may have an internal lumen, and the electrical sensing / stimulator may further include a torque member located within the internal lumen and adapted to apply torque to the extension lead wire body. The torque member may be fixedly attached to the extension lead wire body. The torque member may include a hypotube. The electrical sensing / stimulator may further include a molded wire configured to be positioned within the internal lumen of the extension lead wire body to provide the extension lead wire body with a predetermined shape. The molded wire may be configured to translate and / or rotate axially within the internal lumen. The molded wire may be removable from the internal lumen. The molded wire may be fixed within the internal lumen. The extension lead wire body may be rotatable around the molded wire.

[0024] The extension lead wire body may include an O-ring positioned within its proximal portion. The O-ring may be fitted to prevent fluid from leaking through it to the proximal portion.

[0025] Multiple tissue attachment members may have extended proximal portions that are positioned within the extended lead wire body when the tissue attachment mechanism is retracted and extended. The extended proximal portions of the tissue attachment members may be housed within an outer sheath having a shape that provides a tight fit within the extended lead wire body.

[0026] Aspects of the present disclosure also provide a method for positioning an electrical sensing / stimulation device within body tissue. The elongate lead body of the electrical sensing / stimulation device may be advanced to position the elongate lead body at a target site within a body cavity. The elongate lead body may be torqued to align at least one tissue attachment member of the electrical sensing / stimulation device with target tissue within the target site. A displacement member may be deployed to bias the elongate lead body and at least one tissue attachment member against the target tissue. The tissue attachment member may be actuated to extend from at least one tissue anchor deployment port on the elongate lead body into the target tissue to attach the distal portion of the elongate lead body and an electrode of the electrical sensing / stimulation device to the target tissue. The tissue attachment member may comprise a plurality of tissue attachment members. The plurality of tissue attachment members may be actuated to extend from a common tissue deployment port. Two or more attachment members may branch from each other when deployed from the common tissue deployment port.

[0027] Appropriate attachment of the distal portion of the elongate lead body to the target tissue may be verified, such as by imaging the body cavity in which the elongate lead body is positioned with a fluorescence microscope. When imaging the body cavity with a fluorescence microscope, one or more radiopaque markers coupled to one or more of the elongate lead body, the tissue attachment member, or the displacement member may be identified.

[0028] Physiological parameters, such as cardiac electrical activity or blood pressure, may be sensed using electrodes attached to the target tissue and / or the target tissue may be electrically stimulated using the electrodes.

[0029] After attachment to the target tissue, to release the attachment of the distal portion of the elongate lead body and the electrode from the target tissue, the displacement member may be crushed and the tissue attachment member may be retracted.

[0030] To advance the extension lead wire body, an internal shaping wire may be positioned through the internal lumen of the extension lead wire body to impart a predetermined shape to the extension lead wire body. The predetermined shape may facilitate the advancement of the extension lead wire body through the body lumen.

[0031] A torque member may be placed inside the internal lumen of the extendable lead wire body to apply torque to the extendable lead wire body. A displacement member may be deployed from the outside of the extendable lead wire body. The displacement member may be expanded to a shape that matches the shape of the body cavity. The displacement member may include an expandable element, and the displacement member may be deployed by inflating the expandable element.

[0032] Two or more of the multiple tissue attachment members may be deployed from different tissue deployment ports. Two or more attachment members may be coplanar with each other when deployed from different tissue deployment ports. Two or more tissue attachment members may be deployed at an angle between their deployment surfaces.

[0033] The tissue attachment member may extend from the longitudinal axis of the extension lead wire body when unfolded. The proximal portion of the extension lead wire body may be connected to an external generator. The proximal portion of the extension lead wire body may be connected to an external generator through a magnetic coupler. The proximal portion of the extension lead wire body may be connected to an external generator through an expansion coupler adapted to extend or retract axially. Movement of the attached tissue attachment member relative to the extension lead wire body may be sensed. Sensed movement may be indicated on a handle connected to the extension lead wire body.

[0034] The target body cavity may be at least a portion of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, artery, vein, bladder, ureter, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum.

[0035] Aspects of this disclosure may also provide further electrical sensing / stimulating devices for positioning at least one electrode within body tissue. The electrical sensing / stimulating device may comprise an extendable lead wire body, at least one sensing / stimulating electrode, an expandable displacement member, and a tissue attachment mechanism. The extendable lead wire body has a longitudinal axis. The sensing / stimulating electrode may be connected to the extendable lead wire body. The expandable displacement member may be connected to the extendable lead wire body and adapted to move or bias at least one electrode in a direction specified by the user. The expandable displacement member may have a shape that conforms to a cavity in a body organ or space when expanded. The tissue attachment mechanism may be adapted to attach the distal portion of the extendable lead wire body to body tissue. The tissue attachment mechanism may have a retracted configuration and an extended configuration. In the retracted configuration, the tissue attachment mechanism may be substantially positioned within at least one internal lumen. In the extended configuration, the tissue attachment mechanism may extend from the longitudinal axis of the extendable lead wire body to engage with body tissue.

[0036] The sensing / stimulating electrode may comprise a first electrode and a second electrode, wherein an expandable displacement member can be axially separated from each other, for example, between the first and second electrodes.

[0037] In many embodiments, the expandable member does not extend from the outer surface of the elongated lead wire body when crushed. The expandable member may have an outer circumference larger than the outer circumference of the elongated lead wire body when crushed. The expandable displacement member may be at least partially folded in the crushed configuration. The expandable member in the crushed configuration may have a C-shaped, E-shaped, helical, meandering, or star-shaped cross-section. A radiopaque marker may be mounted on the outer surface of the expandable member. The radiopaque marker may be expandable in conjunction with the expandable marker. The expandable displacement member may be inflatable. The elongated lead wire body may have an expansion lumen to provide an expansion medium for inflating the expandable displacement member. Alternatively, or in combination, the expandable displacement member may comprise a malecot or an expandable cage. Body organs or spaces that conform to the shape of the expanded expandable displacement member may, to name a few, be at least a portion of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, artery, vein, bladder, ureter, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum.

[0038] The extension lead wire body may have one or more ports through which the tissue attachment mechanism is configured to unfold.

[0039] The proximal portion of the extendable lead wire body may be configured to connect to an external generator. The proximal portion of the extendable lead wire body may be configured to connect to an external generator through a magnetic coupler. The proximal portion of the extendable lead wire body may be configured to connect to an external generator through an expansion coupler adapted to extend or retract in the axial direction.

[0040] In the deployed configuration, the tissue attachment mechanism may extend from the longitudinal axis of the extension lead body to penetrate body tissue. Multiple tissue attachment members may be fitted to extend from the longitudinal axis of the extension lead body. One or more of the multiple tissue attachment members may have a curved loop. Two or more of the multiple tissue attachment members may be configured to extend from different ports of the extension lead body. Two or more of the multiple tissue attachment members may be fitted to be coplanar when extended.

[0041] The port through which the tissue attachment mechanism unfolds may have a length that allows the extension lead wire body to move in parallel over the linear portion of one or more of the tissue attachment members. One or more of the tissue attachment members may have a distal wire loop and the distal linear outermost portion of the distal wire loop.

[0042] Two or more of the tissue attachment members may branch off from each other by angles such as less than or equal to 270 degrees, less than or equal to 180 degrees, or less than or equal to 90 degrees, to give a few examples. The tissue attachment members may include hollow needles having an inner lumen through which one or more attachment elements are advanced when at least one tissue attachment member is deployed.

[0043] The electrical sensing / stimulating device may further include a non-traumatic distal lead wire body termination. The distal end of the extension lead wire body may include a non-traumatic distal lead wire body termination. The non-traumatic distal lead wire body termination may include a sensing / stimulating electrode. The non-traumatic distal lead wire body termination may have, to name a few, a rounded, cobra head, curved, bilaterally eccentric, or quadruple eccentric tip. The non-traumatic distal lead wire body termination may include multiple radially extending outward-facing tines.

[0044] The electrical sensing / stimulator may further include a proximal handle connected to an extendable lead wire body. The proximal handle may include one or more controls for activating at least one sensing / stimulating electrode, deploying or retracting a deployable / retractable displacement member, or deploying or retracting a tissue attachment mechanism, or one or more thereof. The proximal handle may include one or more displays for indicating the relative position of the tissue attachment mechanism, the sensed resistance of the tissue engaged by the tissue attachment mechanism, or the amount of sensed current passing through the tissue engaged by the tissue attachment mechanism, or one or more thereof.

[0045] The elongated lead wire body may have an internal lumen, and the electrical sensing / stimulator may further include a torque member located within the internal lumen and adapted to apply torque to the elongated lead wire body. The torque member may be fixedly attached to the elongated lead wire body. The torque member may comprise a tubular braided wire structure laminated with hypotube or polymer. The electrical sensing / stimulator may further include a molded wire configured to be positioned within the internal lumen of the elongated lead wire body to provide the elongated lead wire body with a predetermined shape. The molded wire may be configured to translate and / or rotate axially within the internal lumen. The molded wire may be removable from the internal lumen. The molded wire may be fixed within the internal lumen. The elongated lead wire body may be rotatable around the molded wire.

[0046] The extension lead wire body may include an O-ring positioned within its proximal portion. The O-ring may be fitted to prevent fluid from leaking through it to the proximal portion.

[0047] Multiple tissue attachment members may have extended proximal portions that are positioned within the extended lead wire body when the tissue attachment mechanism is retracted and extended. The extended proximal portions of the tissue attachment members may be housed within an outer sheath having a shape that provides a tight fit within the extended lead wire body.

[0048] Aspects of this disclosure may provide a method for positioning an electrical sensing / stimulating device within body tissue. The extendable lead wire body of the electrical sensing / stimulating device may be advanced to position the extendable lead wire body at a target site within a body cavity. The extendable lead wire body may be torqued to align at least one tissue attachment member of the electrical sensing / stimulating device with target tissue within the target site. A displacement member may be deployed to bias the extendable lead wire body and at least one tissue attachment member against the target tissue, and the expanded displacement member has a shape that conforms to the body cavity. At least one tissue attachment member may be actuated to extend into the target tissue from at least one tissue anchor deployment port on the extendable lead wire body to attach the distal portion of the extendable lead wire body and at least one electrode of the electrical sensing / stimulating device to the target tissue.

[0049] After attachment to the target tissue, the displacement member may be crushed, and at least one tissue attachment member may be retracted, to release the distal portion of the extended lead wire body and at least one electrode from the target tissue.

[0050] The displacement member may extend outward from the outside of the extension lead wire body.

[0051] The displacement member may include an expandable element, and the displacement member may be deployed by expanding the expandable element.

[0052] Body organs or spaces that conform to the shape of the expanded expandable displacement member may, to name a few, be at least a portion of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, artery, vein, bladder, ureter, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum.

[0053] The proper attachment of the distal portion of the extension lead wire body to the target tissue may be verified, for example, by imaging the body cavity in which the extension lead wire body is positioned using a fluorescence microscope. When imaging the body cavity with a fluorescence microscope, one or more radiopaque markers connected to one or more of the extension lead wire body, at least one tissue attachment member, or displacement members may be identified.

[0054] Physiological parameters such as cardiac electrical activity or blood pressure may be sensed using electrodes attached to the target tissue, and / or the target tissue may be electrically stimulated using electrodes.

[0055] To advance the extension lead wire body, an internal shaping wire may be positioned through the internal lumen of the extension lead wire body to impart a predetermined shape to the extension lead wire body. The predetermined shape may facilitate the advancement of the extension lead wire body through the body lumen.

[0056] A torque member may be placed inside the internal lumen of the extendable lead wire body to apply torque to the extendable lead wire body. A displacement member may be deployed from the outside of the extendable lead wire body. The displacement member may be expanded to a shape that matches the shape of the body cavity. The displacement member may include an expandable element, and the displacement member may be deployed by inflating the expandable element.

[0057] Two or more of the tissue attachment members may be deployed from different tissue deployment ports. The two or more attachment members may be coplanar with each other when deployed from different tissue deployment ports, or the deployment surfaces of the tissue attachment member loops may be configured with angles separating them. The two or more tissue attachment members may be deployed with angles between their deployment surfaces.

[0058] The tissue attachment member may extend from the longitudinal axis of the extension lead wire body when deployed. The proximal portion of the extension lead wire body may be connected to an external generator. The proximal portion of the extension lead wire body may be connected to an external generator through a magnetic coupler. The proximal portion of the extension lead wire body may be connected to an external generator through an expansion coupler adapted to extend or retract axially. Movement of the attached tissue attachment member relative to the extension lead wire body may be sensed. Sensed movement may be indicated on a handle connected to the extension lead wire body. The body cavity may be at least a portion of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, artery, vein, bladder, ureter, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum.

[0059] Aspects of this disclosure may also provide an electrical sensing / stimulator for positioning at least one electrode within body tissue. The electrical sensing / stimulator may comprise an extendable lead wire body, at least one sensing / stimulating electrode, a deployable / retractable displacement member, a tissue attachment mechanism, and a molded wire. The extendable lead wire body may have a longitudinal axis. The sensing / stimulating electrode may be connected to the extendable lead wire body. The deployable / retractable displacement member may be connected to the extendable lead wire body and may be adapted to allow the user to move or bias the electrode in a specified direction. The tissue attachment mechanism may be adapted to attach the distal portion of the extendable lead wire body to body tissue. The tissue attachment mechanism may have a retracted configuration and a deployed configuration. In the retracted configuration, the tissue attachment mechanism may be substantially positioned within at least one internal lumen. In the deployed configuration, the tissue attachment mechanism may extend from the longitudinal axis of the extendable lead wire body to engage with body tissue. The molded wire may be configured to be placed inside the internal lumen of the elongated lead wire body so as to provide the elongated lead wire body with a predetermined shape.

[0060] The molded wire may be configured to translate and / or rotate axially within the inner lumen. The molded wire may be removable from the inner lumen. The molded wire may be fixed within the inner lumen. The elongated lead wire body may be rotatable around the molded wire.

[0061] The electrical sensing / stimulator may further include an internal torque member adapted to apply torque to the extension lead wire body. The molded wire may be configured to be positioned within the torque member. The molded wire may be selectively bent by the user.

[0062] The extension lead wire body may have one or more ports through which an organizing attachment mechanism is configured to unfold. The proximal portion of the extension lead wire body may be configured to connect to an external generator. The proximal portion of the extension lead wire body may be configured to connect to an external generator through a magnetic coupler. The proximal portion of the extension lead wire body may be configured to connect to an external generator through an expansion coupler adapted to extend or retract axially.

[0063] The sensing / stimulating electrode may be mounted covering the outer surface of the distal portion of the extendable lead wire body, or embedded inside it, such that a portion of the electrode may be exposed on the outer surface of the extendable lead wire body. At least one sensing / stimulating electrode comprises a first electrode and a second electrode. The first and second electrodes may be axially separated from each other. A deployable / retractable displacement member may be positioned between the first and second electrodes.

[0064] The deployable / retractable displacement member may include an expandable member having a crushing configuration and an expansion configuration. The expandable member may be adapted to unfold outward from the outside of the extension lead wire body. In some embodiments, the expandable member in the crushing configuration does not extend from the outer surface of the extension lead wire body. The expandable member in the crushing configuration may have an outer circumference larger than the outer circumference of the extension lead wire body. The expandable member may be at least partially folded in the crushing configuration. The expandable member in the crushing configuration may have a C-shaped, E-shaped, spiral, meandering, or star-shaped cross-section.

[0065] The electrical sensing / stimulator may further include a radiopaque marker mounted on or embedded inside the outer surface of the expandable member. The radiopaque marker may be expandable in conjunction with the expandable marker. The expandable element may be inflatable. The extension lead wire body may have an expansion lumen to provide an expansion medium for expanding the expandable element.

[0066] The expandable elements may include a mallet or an expandable cage.

[0067] In the deployed configuration, the tissue attachment mechanism may extend from the longitudinal axis of the extension lead wire body so as to penetrate the body tissue.

[0068] Multiple tissue attachment members may be fitted to extend from the longitudinal axis of the extension lead wire body. One or more of the multiple tissue attachment members may have a curved loop. Two or more of the multiple tissue attachment members may be configured to extend from different ports of the extension lead wire body. Two or more of the multiple tissue attachment members may be fitted to be coplanar when extended. Two or more of the multiple tissue attachment members may be configured to extend from a common port of the extension body. Two or more of the multiple tissue attachment members may be fitted such that the planes of unfolding of the tissue attachment members may be at a certain angle to each other when extended.

[0069] The port through which the tissue attachment mechanism unfolds may have a length that allows the extension lead wire body to move in parallel over the linear portion of one or more of the tissue attachment members. One or more of the tissue attachment members may have a distal wire loop and the distal linear outermost portion of the distal wire loop.

[0070] Two or more of the structural mounting members branch off from each other at angles less than or equal to 270 degrees, less than or equal to 180 degrees, or less than or equal to 90 degrees, to give a few examples.

[0071] The tissue attachment member may comprise a hollow needle having an inner lumen through which one or more attachment elements are advanced when at least one tissue attachment member is deployed.

[0072] The electrical sensing / stimulating device may further include a non-traumatic distal lead wire body termination. The distal end of the extension lead wire body may include a non-traumatic distal lead wire body termination. The non-traumatic distal lead wire body termination may include a sensing / stimulating electrode. The non-traumatic distal lead wire body termination may have, to name a few, a rounded, cobra head, curved, bilaterally eccentric, or quadruple eccentric tip. The non-traumatic distal lead wire body termination may include multiple radially extending outward-facing tines.

[0073] The electrical sensing / stimulator may further include a proximal handle connected to an extendable lead wire body. The proximal handle may include one or more controls for activating at least one sensing / stimulating electrode, deploying or retracting a deployable / retractable displacement member, or deploying or retracting a tissue attachment mechanism, or one or more thereof. The proximal handle may include one or more displays for indicating the relative position of the tissue attachment mechanism, the sensed resistance of the tissue engaged by the tissue attachment mechanism, or the amount of sensed current passing through the tissue engaged by the tissue attachment mechanism, or one or more thereof.

[0074] The elongated lead wire body may have an internal lumen, and the electrical sensing / stimulator may further include a torque member located within the internal lumen of the elongated lead wire body and adapted to apply torque to the elongated lead wire body. The torque member may be fixedly attached to the elongated lead wire body. The torque member may comprise a tubular braided wire structure laminated with hypotube or polymer. The electrical sensing / stimulator may further include a molded wire configured to be positioned within the internal lumen of the elongated lead wire body to provide the elongated lead wire body with a predetermined shape. The molded wire may be configured to translate and / or rotate axially within the internal lumen. The molded wire may be removable from the internal lumen. The molded wire may be fixed within the internal lumen. The elongated lead wire body or torque member may be rotatable around the molded wire.

[0075] The extension lead wire body may include an O-ring positioned within its proximal portion. The O-ring may be fitted to prevent fluid from leaking through it to the proximal portion.

[0076] Multiple tissue attachment members may have extended proximal portions that are positioned within the extended lead wire body when the tissue attachment mechanism is retracted and extended. The extended proximal portions of the tissue attachment members may be housed within an outer sheath having a shape that provides a tight fit within the extended lead wire body.

[0077] Aspects of this disclosure may also provide methods for positioning an electrical sensing / stimulating device within body tissue. The extendable lead wire body of the electrical sensing / stimulating device may be advanced to position the extendable lead wire body at a target site within a body cavity. An internal shaping wire may be attached to or advanced axially through the internal lumen of the extendable lead wire body to impart a predetermined shape to the extendable lead wire body, thereby facilitating the advancement of the extendable lead wire body through the body lumen. The extendable lead wire body may be torqued to align at least one tissue attachment member of the electrical sensing / stimulating device with target tissue within the target site. A displacement member may be deployed to bias the extendable lead wire body and the tissue attachment member against the target tissue. The tissue attachment member may be actuated to extend into the target tissue from at least one tissue anchor deployment port on the extendable lead wire body to attach the distal portion of the extendable lead wire body and the electrodes of the electrical sensing / stimulating device to the target tissue.

[0078] The proper attachment of the distal portion of the extension lead wire body to the target tissue may be verified, for example, by imaging the body cavity in which the extension lead wire body is positioned using a fluorescence microscope. When imaging the body cavity with a fluorescence microscope, one or more radiopaque markers connected to one or more of the extension lead wire body, tissue attachment members, or displacement members may be identified.

[0079] Physiological parameters such as cardiac electrical activity or blood pressure may be sensed using electrodes attached to the target tissue, and / or the target tissue may be electrically stimulated using electrodes.

[0080] After attachment to the target tissue, the displacement member may be crushed and the tissue attachment member may be retracted to release the distal portion of the extension lead wire body and the electrode from attachment to the target tissue.

[0081] The internal shaping wire may be positioned through the internal lumen of the extension lead wire body, for example, to impart a predetermined shape to the extension lead wire body in order to facilitate the advancement of the extension lead wire body through the body lumen.

[0082] A torque member may be placed inside the internal lumen of the extendable lead wire body to apply torque to the extendable lead wire body. A displacement member may be deployed from the outside of the extendable lead wire body. The displacement member may be expanded to a shape that matches the shape of the body cavity. The displacement member may include an expandable element, and the displacement member may be deployed by inflating the expandable element.

[0083] Two or more of the multiple tissue attachment members may be deployed from different tissue deployment ports or from a common deployment port. Two or more attachment members may be coplanar with each other when deployed from different tissue deployment ports. Two or more tissue attachment members may be deployed at an angle between their deployment surfaces, or the tissue attachment members may be deployed at an angle to each other.

[0084] The tissue attachment member may extend from the longitudinal axis of the extension lead wire body when unfolded. The proximal portion of the extension lead wire body may be connected to an external generator. The proximal portion of the extension lead wire body may be connected to an external generator through a magnetic coupler. The proximal portion of the extension lead wire body may be connected to an external generator through an expansion coupler adapted to extend or retract axially. Movement of the attached tissue attachment member relative to the extension lead wire body may be sensed. Sensed movement may be indicated on a handle connected to the extension lead wire body.

[0085] The target body cavity may be at least a portion of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, artery, vein, bladder, ureter, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum. Aspects of this disclosure may also provide an electrical sensing / stimulator for positioning at least one electrode within body tissue. The electrical sensing / stimulator may comprise an extendable lead wire body, at least one sensing / stimulating electrode, a deployable / retractable displacement member, a tissue attachment mechanism, and a torque member. The extendable lead wire body may have a longitudinal axis and an internal lumen. The sensing / stimulating electrode may be connected to the extendable lead wire body. The deployable / retractable displacement member may be connected to the extendable lead wire body and adapted to move or bias at least one electrode and / or at least one attachment member in a direction specified by the user. The tissue attachment mechanism may be adapted to attach the distal portion of the extendable lead wire body to body tissue. The tissue attachment mechanism may have a retracted configuration and an extended configuration. In the retracted configuration, the tissue attachment mechanism may be substantially positioned within at least one internal lumen. In the extended configuration, the tissue attachment mechanism may extend from the longitudinal axis of the extendable lead wire body to engage with body tissue. The torque member may be positioned within the inner lumen of the extension lead wire body and adapted to apply torque to the extension lead wire body.

[0086] The torque member may be fixedly attached to the extension lead wire body. The torque member may comprise a tubular braided wire structure laminated with hypotube or polymer. The extension lead wire body may have one or more ports through which the tissue attachment mechanism is configured to unfold. The proximal portion of the extension lead wire body may be configured to connect to an external generator. The proximal portion of the extension lead wire body may be configured to connect to an external generator through a magnetic coupler. The proximal portion of the extension lead wire body may be configured to connect to an external generator through an expansion coupler adapted to extend or retract axially.

[0087] The sensing / stimulating electrode may be mounted covering the outer surface of the distal portion of the extendable lead wire body, or embedded inside it, such that a portion of the electrode may be exposed on the outer surface of the extendable lead wire body. At least one sensing / stimulating electrode comprises a first electrode and a second electrode. The first and second electrodes may be axially separated from each other. A deployable / retractable displacement member may be positioned between the first and second electrodes.

[0088] The deployable / retractable displacement member may include an expandable member having a crushing configuration and an expansion configuration. The expandable member may be adapted to unfold outward from the outside of the extension lead wire body. In some embodiments, the expandable member in the crushing configuration does not extend from the outer surface of the extension lead wire body. The expandable member in the crushing configuration may have an outer circumference larger than the outer circumference of the extension lead wire body. The expandable member may be at least partially folded in the crushing configuration. The expandable member in the crushing configuration may have a C-shaped, E-shaped, spiral, meandering, or star-shaped cross-section.

[0089] The electrical sensing / stimulator may further include a radiopaque marker mounted on the outer surface of an expandable member. The radiopaque marker may be expandable in conjunction with the expandable marker. The expandable element may be inflatable. The extension lead wire body may have an expansion lumen to provide an expansion medium for expanding the expandable element.

[0090] The expandable elements may include a mallet or an expandable cage.

[0091] In the deployed configuration, the tissue attachment mechanism may extend from the longitudinal axis of the extension lead wire body so as to penetrate the body tissue.

[0092] Multiple tissue attachment members may be fitted to extend from the longitudinal axis of the extension lead wire body. One or more of the multiple tissue attachment members may have a curved loop. Two or more of the multiple tissue attachment members may extend from different ports of the extension lead wire body. Two or more of the multiple tissue attachment members may be fitted to be coplanar when expanded, or their unfolded surfaces may be angled relative to each other.

[0093] The common port may have a length that allows the extension lead wire body to move in parallel over the linear portion of one or more of the tissue attachment members. One or more of the tissue attachment members may have a distal wire loop and the distal linear outermost portion of the distal wire loop.

[0094] Two or more of the structural mounting members branch off from each other at angles less than or equal to 270 degrees, less than or equal to 180 degrees, or less than or equal to 90 degrees, to give a few examples.

[0095] The tissue attachment member may comprise a hollow needle having an inner lumen through which one or more attachment elements are advanced when at least one tissue attachment member is deployed.

[0096] The electrical sensing / stimulating device may further include a non-traumatic distal lead wire body termination. The distal end of the extension lead wire body may include a non-traumatic distal lead wire body termination. The non-traumatic distal lead wire body termination may include a sensing / stimulating electrode. The non-traumatic distal lead wire body termination may have, to name a few, a rounded, cobra head, curved, bilaterally eccentric, or quadruple eccentric tip. The non-traumatic distal lead wire body termination may include multiple radially extending outward-facing tines.

[0097] The electrical sensing / stimulator may further include a proximal handle connected to an extendable lead wire body. The proximal handle may include one or more controls for activating at least one sensing / stimulating electrode, deploying or retracting a deployable / retractable displacement member, or deploying or retracting a tissue attachment mechanism, or one or more thereof. The proximal handle may include one or more displays for indicating the relative position of the tissue attachment mechanism, the sensed resistance of the tissue engaged by the tissue attachment mechanism, or the amount of sensed current passing through the tissue engaged by the tissue attachment mechanism, or one or more thereof.

[0098] The extension lead wire body may include an O-ring positioned within its proximal portion. The O-ring may be fitted to prevent fluid from leaking through it to the proximal portion.

[0099] Multiple tissue attachment members may have extended proximal portions that are positioned within the extended lead wire body when the tissue attachment mechanism is retracted and extended. The extended proximal portions of the tissue attachment members may be housed within an outer sheath having a shape that provides a tight fit within the extended lead wire body.

[0100] Aspects of this disclosure may provide a method for positioning an electrical sensing / stimulating device within body tissue. The extendable lead wire body of the electrical sensing / stimulating device may be advanced to position the extendable lead wire body at a target site within a body cavity. A torque member positioned within the inner lumen of the extendable lead wire body may be torqued to apply torque to the extendable lead wire body or to rotate it axially in order to align at least one tissue attachment member of the electrical sensing / stimulating device with target tissue within the target site. A displacement member may be deployed to bias the extendable lead wire body and the tissue attachment member against the target tissue. The tissue attachment member may be actuated to extend into the target tissue from at least one tissue anchor deployment port on the extendable lead wire body to attach the distal portion of the extendable lead wire body and the electrodes of the electrical sensing / stimulating device to the target tissue.

[0101] The proper attachment of the distal portion of the extension lead wire body to the target tissue may be verified, for example, by imaging the body cavity in which the extension lead wire body is positioned using a fluorescence microscope. When imaging the body cavity with a fluorescence microscope, one or more radiopaque markers connected to one or more of the extension lead wire body, tissue attachment members, or displacement members may be identified.

[0102] Physiological parameters such as cardiac electrical activity or blood pressure may be sensed using electrodes attached to the target tissue, and / or the target tissue may be electrically stimulated using electrodes.

[0103] After attachment to the target tissue, the displacement member may be crushed and the tissue attachment member may be retracted to release the distal portion of the extension lead wire body and the electrode from attachment to the target tissue.

[0104] The displacement member may be deployed from the outside of the extension lead wire body, for example, by expanding the displacement member. The displacement member may be expanded to a shape that conforms to the shape of the body cavity. The displacement member may include an expandable element, and the displacement member may be deployed by inflating the expandable element. Two or more of the tissue attachment members may be deployed from different tissue deployment ports or from a common deployment port. Two or more attachment members may be coplanar with each other when deployed from different tissue deployment ports or a common delivery port, or the planes of the tissue attachment members may be deployed at an angle to each other. Two or more tissue attachment members may be deployed at an angle between the deployment surfaces of the tissue attachment members.

[0105] At least one tissue attachment member may extend from the longitudinal axis of the extension lead wire body when deployed. The proximal portion of the extension lead wire body may be connected to an external generator. The proximal portion of the extension lead wire body may be connected to an external generator through a magnetic coupler. The proximal portion of the extension lead wire body may be connected to an external generator through an expansion coupler adapted to extend or retract axially. Movement of the attached tissue attachment member relative to the extension lead wire body may be sensed. Sensed movement may be indicated on a handle connected to the extension lead wire body.

[0106] The target body cavity may be at least a portion of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, artery, vein, bladder, ureter, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum. This specification provides, for example, the following items: (Item 1) An electrical sensing / stimulating device for positioning at least one electrode within body tissue, wherein the electrical sensing / stimulating device is An extendable lead wire body having a vertical axis, Connected to the above-mentioned extended lead wire body is at least one sensing / stimulating electrode, A deployable / retractable displacement member, connected to the above-mentioned extendable lead wire body and adapted to allow the user to move or bias the above-mentioned at least one electrode in a specified direction, A tissue attachment mechanism adapted to attach the distal portion of the above-mentioned extendable lead wire body to body tissue, wherein the tissue attachment mechanism has a retracted configuration and an extended configuration. Equipped with, In the retracted configuration described above, the tissue attachment mechanism is substantially located within at least one internal lumen, and in the deployed configuration described above, the tissue attachment mechanism extends from the longitudinal axis of the extension lead wire body to engage with body tissue. The above tissue attachment mechanism comprises a plurality of tissue attachment members adapted to extend from the common port of the extension lead wire body, Two or more of the above-mentioned multiple organizational mounting members are adapted to branch off from each other when extended from the common port. Electrical sensing / stimulator. (Item 2) The electrical sensing / stimulating device according to item 1, wherein the extension lead wire body has one or more ports through which the tissue attachment mechanism is deployed. (Item 3) The proximal portion of the extended lead wire body described above is configured to be connected to an external generator, as described in item 1, for the electrical sensing / stimulating device. (Item 4) The electrical sensing / stimulating device according to item 3, wherein the proximal portion of the extended lead wire body is configured to be connected to the external generator via a magnetic coupler. (Item 5) The electrical sensing / stimulating device according to item 3, wherein the proximal portion of the extension lead wire body is configured to connect to the external generator through an expansion connector adapted to extend or retract in the axial direction. (Item 6) The electrical sensing / stimulating device according to item 1, wherein at least one sensing / stimulating electrode is mounted covering the outer surface of the distal portion of the extension lead wire body. (Item 7) The electrical sensing / stimulating device according to item 1, wherein the above-mentioned sensing / stimulating electrode comprises a first electrode and a second electrode. (Item 8) The first electrode and the second electrode described above are separated from each other in the axial direction, as described in item 7, in the electrical sensing / stimulator. (Item 9) The deployable / retractable displacement member is positioned between the first and second electrodes in the electrical sensing / stimulator described in item 7. (Item 10) The above deployable / retractable displacement member comprises an expandable member having a crushing configuration and an expansion configuration, as described in item 1, for the electrical sensing / stimulation device. (Item 11) The expandable member described above is adapted to unfold outwards from the outside of the main body of the extendable lead wire, as described in item 10 of the electrical sensing / stimulating device. (Item 12) The electrical sensing / stimulating device according to item 10, wherein the expandable member in the above-described crushing configuration does not extend from the outer surface of the elongated lead wire body. (Item 13) The electrical sensing / stimulating device according to item 10, wherein the expandable member in the above-described crushing configuration has an outer circumference larger than the outer circumference of the elongated lead wire body. (Item 14) The expandable member described above is at least partially folded in the crushed configuration, as described in item 10, for the electrical sensing / stimulating device. (Item 15) The expandable member in the above-described crushing configuration has a C-shaped, E-shaped, spiral, meandering, or star-shaped cross-section, as described in item 14, for the electrical sensing / stimulating device. (Item 16) The electrical sensing / stimulating device described in item 10, further comprising a radiopaque marker mounted on the outer surface of the expandable member described above. (Item 17) The above-mentioned radiopaque marker is expandable in conjunction with an expandable marker in the electrical sensing / stimulating device as described in item 16. (Item 18) The above expandable element is an inflatable type, as described in item 16, for electrical sensing / stimulation devices. (Item 19) The electrical sensing / stimulating device according to item 18, wherein the extension lead wire body has an expansion lumen to provide an expansion medium for expanding the expandable element. (Item 20) The above expandable element is an electrosensing / stimulating device as described in item 16, comprising a malecot or expandable cage. (Item 21) The expandable element in the above-described expansion configuration is molded to fit a cavity in a body organ or space, as described in item 16, for the electrosensing / stimulating device. (Item 22) The electrical sensing / stimulator described in item 21, wherein the above-mentioned body organ or space is at least a portion of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, artery, vein, bladder, ureter, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum. (Item 23) In the above configuration, the tissue attachment mechanism extends from the longitudinal axis of the extension lead wire body so as to penetrate the body tissue, as described in item 1, for the electrical sensing / stimulating device. (Item 24) The above-mentioned multiple tissue attachment members are adapted to extend from the longitudinal axis of the above-mentioned extension lead wire body, as described in item 1, for the electrical sensing / stimulating device. (Item 25) One or more of the above-mentioned tissue attachment members are tissue attachment members comprising a curved loop, as described in item 1, in the electrical sensing / stimulating device. (Item 26) The electrical sensing / stimulating device according to item 1, wherein two or more of the tissue attachment members described above are configured to extend from different ports of the extension lead wire body. (Item 27) Two or more of the above-mentioned tissue attachment members are fitted to be coplanar when expanded, as described in item 26, for the electrical sensing / stimulating device. (Item 28) The electrical sensing / stimulating device according to item 1, wherein the common port has a length that allows the extension lead wire body to move in parallel over a linear portion of one or more of the tissue attachment members. (Item 29) An electrical sensing / stimulating device according to item 28, wherein one or more of the tissue attachment members described above comprises a distal wire loop and the distal linear most distal portion of the distal wire loop. (Item 30) Two or more of the above-mentioned tissue attachment members branch off from each other by an angle of less than or equal to 270 degrees, as described in item 1 of the electrical sensing / stimulating device. (Item 31) The electrosensing / stimulating device according to item 1, comprising a hollow needle having an inner lumen through which one or more attachment elements are advanced when the at least one tissue attachment member is deployed. (Item 32) An electrical sensing / stimulator as described in item 1, further comprising a non-traumatic distal lead wire body termination. (Item 33) The electrical sensing / stimulating device according to item 32, wherein the distal end of the extension lead wire body is provided with the non-traumatic distal lead wire body termination. (Item 34) The above non-traumatic distal lead wire body termination is an electrical sensing / stimulating device as described in item 32, comprising a sensing / stimulating electrode. (Item 35) The non-traumatic distal lead wire body termination has a rounded, cobra head, curved, bilaterally eccentric, or quadruple-eccentric tip, as described in item 32, for the electrical sensing / stimulator. (Item 36) The above non-traumatic distal lead wire body termination comprises a plurality of radially extending outward-facing tines, as described in item 32, for the electrical sensing / stimulating device. (Item 37) The electrical sensing / stimulating device described in item 1, further comprising a proximal handle connected to the above-mentioned extended lead wire body. (Item 38) The electrosensing / stimulating device according to item 1, wherein the proximal handle comprises one or more controls for activating the at least one sensing / stimulating electrode, deploying or retracting the deployable / retractable displacement member, or deploying or retracting the tissue attachment mechanism, or more than one thereof. (Item 39) The electrical sensing / stimulator according to item 1, wherein the proximal handle comprises one or more displays for indicating one or more of the following: the relative position of the tissue attachment mechanism, the sensed resistance of the tissue engaged by the tissue attachment mechanism, or the amount of sensed current passing through the tissue engaged by the tissue attachment mechanism. (Item 40) The electrical sensing / stimulating device according to item 1, wherein the extended lead wire body has an internal lumen, and the electrical sensing / stimulating device further comprises a torque member located within the internal lumen and adapted to apply torque to the extended lead wire body. (Item 41) The torque member described above is fixedly attached to the main body of the extension lead wire, and is an electrical sensing / stimulating device as described in item 40. (Item 42) The above torque member comprises a hypotube and is an electrical sensing / stimulator as described in item 40. (Item 43) The electrical sensing / stimulating device according to item 40, further comprising a molded wire configured to be placed within the internal lumen of the elongated lead wire body in order to provide the elongated lead wire body with a predetermined shape. (Item 44) The electrosensing / stimulating device according to item 43, wherein the molded wire is configured to move axially parallel within the inner lumen. (Item 45) The above-mentioned molded wire is removable from the above-mentioned inner lumen, as described in item 43, for the electrical sensing / stimulating device. (Item 46) The above-mentioned molded wire is fixed within the above-mentioned inner lumen, in the electrical sensing / stimulating device described in item 43. (Item 47) The above-mentioned extended lead wire body is rotatable around the above-mentioned molded wire, as described in item 43, for the electrical sensing / stimulating device. (Item 48) The electrical sensing / stimulating device as described in item 1, wherein the extended lead wire body comprises an O-ring positioned within its proximal portion, the O-ring being fitted to prevent fluid from leaking through it to the proximal portion. (Item 49) The electrical sensing / stimulating device according to item 1, wherein the plurality of tissue attachment members have an extended proximal portion that is positioned within the extended lead wire body when the tissue attachment mechanism is retracted and extended. (Item 50) The electrical sensing / stimulating device according to item 49, wherein the proximal extension portion of the tissue attachment member is shaped to provide a crimping fit within the main body of the extension lead wire and is housed within an outer sheath. (Item 51) A method for positioning an electrical sensing / stimulation device within body tissue, The steps include: advancing the extension lead wire body of the electrical sensing / stimulating device so that it is positioned at a target site within the body cavity; The steps include applying torque to the extended lead wire body so that at least one tissue attachment member of the electrical sensing / stimulation device is aligned with the target tissue within the target site, The steps include deploying a displacement member to bias the extension lead wire body and the at least one tissue attachment member toward the target tissue, The steps include: activating the at least one tissue attachment member so that it extends from at least one tissue anchor deployment port on the extension lead wire body into the target tissue in order to attach the distal portion of the extension lead wire body and at least one electrode of the electrical sensing / stimulation device to the target tissue; Includes, The above-mentioned at least one tissue attachment member comprises a plurality of tissue attachment members, The step of operating the at least one tissue attachment member so as to extend from the at least one tissue deployment port includes the step of operating the plurality of tissue attachment members so as to extend from a common tissue deployment port. A method by which two or more mounting members branch off from each other when deployed from the common organization deployment port described above. (Item 52) The method according to item 51, further comprising the step of verifying the proper attachment of the distal portion of the extended lead wire body to the target tissue. (Item 53) The method according to item 52, wherein the step of verifying the proper attachment of the distal portion of the extension lead wire body to the target tissue includes the step of imaging the body cavity in which the extension lead wire body is positioned using a fluorescence microscope. (Item 54) The method according to item 53, wherein the step of imaging the body cavity with a fluorescence microscope includes the step of identifying one or more radiopaque markers connected to one or more of the extension lead wire body, the at least one tissue attachment member, or the displacement member. (Item 55) The method according to item 51, further comprising the step of sensing physiological parameters using at least one electrode attached to the target tissue. (Item 56) The method according to item 51, further comprising the step of stimulating the target tissue using at least one of the electrodes described above. (Item 57) The method according to item 51, further comprising the step of crushing the displacement member and retracting the at least one tissue attachment member after attachment to the target tissue, so as to release the distal portion of the extension lead wire body and the at least one electrode from attachment to the target tissue. (Item 58) The method according to item 51, wherein the step of advancing the extension lead wire body includes the step of positioning an internal shaping wire through the internal lumen of the extension lead wire body so as to impart a predetermined shape to the extension lead wire body, the predetermined shape facilitating the advancement of the extension lead wire body through the internal lumen. (Item 59) The method according to item 51, wherein the step of applying torque to the extension lead wire body includes the step of rotating a torque member disposed within the internal lumen of the extension lead wire body. (Item 60) The displacement member is deployed from the outside of the extension lead wire body, as described in item 51. (Item 61) The method according to item 51, wherein the step of unfolding the displacement member includes the step of extending the displacement member. (Item 62) The method according to item 61, wherein the displacement member is expanded to a shape that matches the shape of the body cavity. (Item 63) The method according to item 61, wherein the displacement member comprises an expandable element, and the step of unfolding the displacement member includes the step of inflating the expandable member. (Item 64) The method according to item 51, wherein two or more of the above-mentioned tissue attachment members are deployed from different tissue deployment ports. (Item 65) The method of item 64, wherein the two or more mounting members described above are coplanar with each other when deployed from the different organizational deployment ports described above. (Item 66) The method according to item 51, wherein at least one of the above-mentioned tissue attachment members extends from the longitudinal axis of the extended lead wire body when unfolded. (Item 67) The method according to item 51, further comprising the step of connecting the proximal portion of the extended lead wire body described above to an external generator. (Item 68) The method according to item 67, wherein the proximal portion of the extended lead wire body is connected to the external generator through a magnetic coupler. (Item 69) The method according to item 67, wherein the proximal portion of the extension lead wire body is connected to the external generator through an extension coupler adapted to extend or retract in the axial direction. (Item 70) The method according to item 51, further comprising the step of sensing the movement of the at least one tissue attachment member attached to the extension lead wire body. (Item 71) The method according to item 70, further comprising the step of displaying the detected movement on a handle connected to the extension lead wire body described above. (Item 72) The method according to item 71, wherein the body cavity is at least a portion of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, artery, vein, bladder, ureter, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum. (Item 73) An electrical sensing / stimulating device for positioning at least one electrode within body tissue, An extendable lead wire body having a vertical axis, Connected to the above-mentioned extended lead wire body is at least one sensing / stimulating electrode, An expandable displacement member connected to the above-mentioned extendable lead wire body and adapted to move or bias the above-mentioned at least one electrode in a direction specified by the user, having a shape that conforms to a body organ or cavity when expanded, A tissue attachment mechanism, which is adapted to attach the distal portion of the above-mentioned extendable lead wire body to body tissue, having a retracted configuration and an extended configuration, Equipped with, An electrical sensing / stimulating device, wherein in the retracted configuration, the tissue attachment mechanism is substantially located within the at least one internal lumen, and in the deployed configuration, the tissue attachment mechanism extends from the longitudinal axis of the extension lead wire body to engage with body tissue. (Item 74) The electrical sensing / stimulating device according to item 73, wherein the above-mentioned at least one sensing / stimulating electrode comprises a first electrode and a second electrode. (Item 75) The first electrode and the second electrode described above are separated from each other axially, as described in item 74, in the electrical sensing / stimulator. (Item 76) The expandable displacement member is positioned between the first and second electrodes in the electrical sensing / stimulator according to item 75. (Item 77) The expandable member described above does not extend from the outer surface of the elongated lead wire body when compressed, as described in item 73 of the electrical sensing / stimulating device. (Item 78) The electrical sensing / stimulating device according to item 73, wherein the expandable member has an outer circumference larger than the outer circumference of the elongated lead wire body when compressed. (Item 79) The expandable displacement member described above is at least partially folded in the crushing configuration, as described in item 73, for the electrical sensing / stimulator. (Item 80) The expandable member in the above-described crushing configuration has a C-shaped, E-shaped, spiral, meandering, or star-shaped cross-section, as described in item 79, for the electrical sensing / stimulating device. (Item 81) The electrical sensing / stimulating device described in item 73 further comprises a radiopaque marker mounted on the outer surface of the expandable displacement member described above. (Item 82) The above-mentioned radiopaque marker is expandable in conjunction with an expandable marker, as described in item 81, for the electrical sensing / stimulating device. (Item 83) The above expandable displacement member is an expandable type, as described in item 82, for the electrical sensing / stimulator. (Item 84) The electrical sensing / stimulating device according to item 83, wherein the extension lead wire body has an expansion lumen to provide an expansion medium for expanding the expandable displacement member. (Item 85) The above expandable displacement member comprises a malecot or expandable cage, as described in item 73, for the electrical sensing / stimulator. (Item 86) The electrical sensing / stimulating device described in item 73, wherein the above-mentioned body organ or space is at least a portion of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, artery, vein, bladder, ureter, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum. (Item 87) The electrical sensing / stimulating device according to item 73, wherein the extension lead wire body has one or more ports through which the tissue attachment mechanism is deployed. (Item 88) The proximal portion of the extended lead wire body described above is configured to be connected to an external generator, as described in item 73, for the electrical sensing / stimulating device. (Item 89) The electrical sensing / stimulating device according to item 88, wherein the proximal portion of the extended lead wire body is configured to be connected to the external generator through a magnetic coupler. (Item 90) The electrical sensing / stimulating device according to item 88, wherein the proximal portion of the extension lead wire body is configured to connect to the external generator through an expansion connector adapted to extend or retract in the axial direction. (Item 91) In the above deployment configuration, the tissue attachment mechanism extends from the longitudinal axis of the extension lead wire body so as to penetrate the body tissue, as described in item 73, for the electrical sensing / stimulating device. (Item 92) The above-mentioned multiple tissue attachment members are adapted to extend from the longitudinal axis of the above-mentioned extension lead wire body, as described in item 73, for the electrical sensing / stimulating device. (Item 93) One or more of the above-mentioned tissue attachment members are tissue attachment members comprising a curved loop, as described in item 73, for the electrosensing / stimulating device. (Item 94) The electrical sensing / stimulating device according to item 73, wherein two or more of the tissue attachment members described above are configured to extend from different ports of the extension lead wire body. (Item 95) Two or more of the above-mentioned tissue attachment members are fitted to be coplanar when expanded, as described in item 94 of the electrical sensing / stimulator. (Item 96) The electrical sensing / stimulating device according to item 73, wherein the port through which the tissue attachment mechanism unfolds has a length that allows the extension lead wire body to move in parallel over a linear portion of one or more of the tissue attachment members. (Item 97) An electrical sensing / stimulating device according to item 95, wherein one or more of the tissue attachment members described above comprises a distal wire loop and the distal linear most distal portion of the distal wire loop. (Item 98) Two or more of the above-mentioned tissue attachment members branch off from each other by an angle of less than or equal to 270 degrees, as described in item 73 of the electrical sensing / stimulating device. (Item 99) The electrosensing / stimulating device according to item 73, comprising a hollow needle having an inner lumen through which one or more attachment elements are advanced when the at least one tissue attachment member is deployed. (Item 100) An electrical sensing / stimulating device as described in item 73, further comprising a non-traumatic distal lead wire body termination. (Item 101) The electrical sensing / stimulating device according to item 99, wherein the distal end of the extension lead wire body is provided with the non-traumatic distal lead wire body termination. (Item 102) The above non-traumatic distal lead wire body termination comprises an electrical sensing / stimulating device as described in item 99, which includes a sensing / stimulating electrode. (Item 103) The non-traumatic distal lead wire body termination has a rounded, cobra head, curved, bilaterally eccentric, or quadruple-eccentric tip, as described in item 99 of the electrical sensing / stimulator. (Item 104) The above non-traumatic distal lead wire body termination comprises a plurality of radially extending outward-facing tines, as described in item 99, for the electrical sensing / stimulating device. (Item 105) An electrical sensing / stimulating device as described in item 73, further comprising a proximal handle connected to the above-mentioned extension lead wire body. (Item 106) The electrosensing / stimulating device according to item 73, wherein the proximal handle comprises one or more controls for activating the at least one sensing / stimulating electrode, deploying or retracting the deployable / retractable displacement member, or deploying or retracting the tissue attachment mechanism, or more than one of these. (Item 107) The electrosensing / stimulating device according to item 73, wherein the proximal handle comprises one or more displays for indicating one or more of the following: the relative position of the tissue attachment mechanism, the sensed resistance of the tissue engaged by the tissue attachment mechanism, or the amount of sensed current passing through the tissue engaged by the tissue attachment mechanism. (Item 108) The electrical sensing / stimulating device according to item 73, wherein the extended lead wire body has an internal lumen, and the electrical sensing / stimulating device further comprises a torque member located in the internal lumen and adapted to apply torque to the extended lead wire body. (Item 109) The torque member described above is fixedly attached to the extension lead wire body, and is an electrical sensing / stimulating device as described in item 107. (Item 110) The above torque member comprises a hypotube, as described in item 107, in the electrical sensing / stimulating device. (Item 111) The electrical sensing / stimulating device according to item 109, further comprising a molded wire configured to be placed within the internal lumen of the elongated lead wire body in order to provide the elongated lead wire body with a predetermined shape. (Item 112) The electrosensing / stimulating device according to item 110, wherein the molded wire is configured to move axially parallel within the inner lumen. (Item 113) The above-mentioned molded wire is removable from the above-mentioned inner lumen, as described in item 110, for the electrical sensing / stimulating device. (Item 114) The above-mentioned molded wire is fixed within the above-mentioned inner lumen in the electrical sensing / stimulating device described in item 110. (Item 115) The above-mentioned extended lead wire body is rotatable around the above-mentioned molded wire, in the electrical sensing / stimulating device as described in item 110. (Item 116) The electrical sensing / stimulating device as described in item 73, wherein the extended lead wire body comprises an O-ring positioned within its proximal portion, the O-ring being fitted to prevent fluid from leaking through it to the proximal portion. (Item 117) The electrical sensing / stimulating device according to item 73, wherein the plurality of tissue attachment members have extended proximal portions that are positioned within the extended lead wire body when the tissue attachment mechanism is retracted and extended. (Item 118) The above-mentioned tissue attachment member has an extended proximal portion that is shaped to provide a crimping fit within the extended lead wire body, and is housed within an outer sheath, as described in item 116. (Item 119) A method for positioning an electrical sensing / stimulation device within body tissue, The steps include: advancing the extension lead wire body of the electrical sensing / stimulating device so that it is positioned at a target site within the body cavity; The steps include applying torque to the extended lead wire body so that at least one tissue attachment member of the electrical sensing / stimulation device is aligned with the target tissue within the target site, A step of extending a displacement member so as to bias the extension lead wire body and the at least one tissue attachment member toward the target tissue, wherein the extended displacement member has a shape that conforms to the body cavity, The steps include: activating the at least one tissue attachment member so that it extends from at least one tissue anchor deployment port on the extension lead wire body into the target tissue in order to attach the distal portion of the extension lead wire body and at least one electrode of the electrical sensing / stimulation device to the target tissue; Methods that include... (Item 120) The method according to item 118, further comprising the step of crushing the displacement member and retracting the at least one tissue attachment member after attachment to the target tissue, so as to release the distal portion of the extension lead wire body and the at least one electrode from attachment to the target tissue. (Item 121) The displacement member is extended outward from the outside of the main body of the extension lead wire, as described in item 118. (Item 122) The method according to item 118, wherein the displacement member comprises an expandable element, and the step of unfolding the displacement member includes the step of inflating the expandable member. (Item 123) The method according to item 118, wherein the body cavity is at least a portion of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, artery, vein, bladder, ureter, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum. (Item 124) The method according to item 118, further comprising the step of verifying the proper attachment of the distal portion of the extended lead wire body to the target tissue. (Item 125) The method according to item 123, wherein the step of verifying the proper attachment of the distal portion of the extension lead wire body to the target tissue includes the step of imaging the body cavity in which the extension lead wire body is positioned using a fluorescence microscope. (Item 126) The method according to item 124, wherein the step of imaging the body cavity with a fluorescence microscope includes the step of identifying one or more radiopaque markers connected to one or more of the extension lead wire body, the at least one tissue attachment member, or the displacement member. (Item 127) The method according to item 118, further comprising the step of sensing physiological parameters using at least one electrode attached to the target tissue. (Item 128) The method according to item 118, further comprising the step of stimulating the target tissue using at least one of the electrodes described above. (Item 129) The method according to item 118, wherein the step of advancing the extension lead wire body includes the step of positioning an internal shaping wire through the internal lumen of the extension lead wire body so as to impart a predetermined shape to the extension lead wire body, the predetermined shape facilitating the advancement of the extension lead wire body through the internal lumen. (Item 130) The method according to item 118, wherein the step of applying torque to the extension lead wire body includes the step of rotating a torque member disposed within the internal lumen of the extension lead wire body. (Item 131) The tissue attachment mechanism according to item 118, comprising a plurality of tissue attachment members, wherein two or more of the plurality of tissue attachment members are deployed from different tissue deployment ports. (Item 132) The method according to item 130, wherein the two or more mounting members described above are coplanar with each other when deployed from the different organizational deployment ports described above. (Item 133) The method according to item 118, wherein at least one of the above-mentioned tissue attachment members extends from the longitudinal axis of the extended lead wire body when unfolded. (Item 134) The method according to item 118, further comprising the step of connecting the proximal portion of the extended lead wire body described above to an external generator. (Item 135) The method according to item 133, wherein the proximal portion of the extended lead wire body is connected to the external generator through a magnetic coupler. (Item 136) The method according to item 133, wherein the proximal portion of the extension lead wire body is connected to the external generator through an extension coupler adapted to extend or retract in the axial direction. (Item 137) The method according to item 118, further comprising the step of sensing the movement of the at least one tissue attachment member attached to the extension lead wire body. (Item 138) The method according to item 136, further comprising the step of displaying the detected movement on a handle connected to the extension lead wire body described above. (Item 139) An electrical sensing / stimulating device for positioning at least one electrode within body tissue, An extendable lead wire body having a vertical axis, Connected to the above-mentioned extended lead wire body is at least one sensing / stimulating electrode, A deployable / retractable displacement member, connected to the above-mentioned extendable lead wire body and adapted to allow the user to move or bias the above-mentioned at least one electrode in a specified direction, A tissue attachment mechanism adapted to attach the distal portion of the extension lead wire body to body tissue, wherein the tissue attachment mechanism has a retracted configuration and an extended configuration, in the retracted configuration the tissue attachment mechanism is substantially located within the at least one internal lumen, and in the extended configuration the tissue attachment mechanism extends from the longitudinal axis of the extension lead wire body to engage with body tissue. A molded wire, configured to be placed inside the internal lumen of the elongated lead wire body in order to provide the elongated lead wire body with a predetermined shape, An electrical sensing / stimulating device equipped with the following features. (Item 140) The electrosensing / stimulating device according to item 138, wherein the molded wire is configured to move axially in parallel within the inner lumen. (Item 141) The above-mentioned molded wire is removable from the above-mentioned inner lumen, as described in item 138, for the electrical sensing / stimulating device. (Item 142) The above-mentioned molded wire is fixed within the above-mentioned inner lumen in the electrical sensing / stimulating device described in item 138. (Item 143) The above-mentioned extended lead wire body is rotatable around the above-mentioned molded wire, in the electrical sensing / stimulating device as described in item 138. (Item 144) The electrical sensing / stimulating device according to item 138, further comprising a torque member within the inner lumen, which is adapted to apply torque to the extension lead wire body, wherein the molded wire is configured to be positioned within the torque member. (Item 145) The above-mentioned molded wire is curved, as described in item 138 for the electrical sensing / stimulator. (Item 146) The electrical sensing / stimulating device according to item 138, wherein the extension lead wire body has one or more ports through which the tissue attachment mechanism is deployed. (Item 147) The proximal portion of the extended lead wire body described above is configured to be connected to an external generator, as described in item 138, for the electrical sensing / stimulating device. (Item 148) The electrical sensing / stimulating device according to item 146, wherein the proximal portion of the extended lead wire body is configured to be connected to the external generator through a magnetic coupler. (Item 149) The electrical sensing / stimulating device according to item 146, wherein the proximal portion of the extension lead wire body is configured to connect to the external generator through an expansion connector adapted to extend or retract in the axial direction. (Item 150) The electrical sensing / stimulating device according to item 138, wherein at least one of the sensing / stimulating electrodes is mounted covering the outer surface of the distal portion of the extension lead wire body. (Item 151) The above-mentioned electrical sensing / stimulating device according to item 138, wherein the at least one sensing / stimulating electrode comprises a first electrode and a second electrode. (Item 152) The first electrode and the second electrode described above are separated from each other axially in the electrical sensing / stimulator as described in item 150. (Item 153) The above-mentioned deployable / retractable displacement member is positioned between the first and second electrodes in the electrical sensing / stimulator described in item 150. (Item 154) The above deployable / retractable displacement member comprises an expandable member having a crushing configuration and an expansion configuration, as described in item 138, for the electrical sensing / stimulation device. (Item 155) The expandable member described above is adapted to unfold outwards from the outside of the main body of the extendable lead wire, as described in item 153 of the electrical sensing / stimulator. (Item 156) The electrical sensing / stimulating device according to item 153, wherein the expandable member in the above-described crushing configuration does not extend from the outer surface of the elongated lead wire body. (Item 157) The electrical sensing / stimulating device according to item 153, wherein the expandable member in the above-described crushing configuration has an outer circumference larger than the outer circumference of the elongated lead wire body. (Item 158) The expandable member described above is at least partially folded in the crushed configuration, as described in item 153, for the electrical sensing / stimulator. (Item 159) The expandable member in the above-described crushing configuration has a C-shaped, E-shaped, spiral, meandering, or star-shaped cross-section, as described in item 157, for the electrical sensing / stimulating device. (Item 160) The electrical sensing / stimulating device described in item 153 further comprises a radiopaque marker mounted on the outer surface of the expandable member described above. (Item 161) The above-mentioned radiopaque marker is expandable in conjunction with an expandable marker in the electrical sensing / stimulating device as described in item 159. (Item 162) The above expandable element is an inflatable type, as described in item 159, for electrical sensing / stimulation devices. (Item 163) The electrical sensing / stimulating device according to item 161, wherein the extension lead wire body has an expansion lumen to provide an expansion medium for expanding the expandable element. (Item 164) The above expandable element comprises a malecot or expandable cage, as described in item 159, for the electrosensing / stimulating device. (Item 165) In the above deployment configuration, the tissue attachment mechanism extends from the longitudinal axis of the extension lead wire body so as to penetrate the body tissue, as described in item 138, an electrical sensing / stimulating device. (Item 166) The above-mentioned multiple tissue attachment members are adapted to extend from the longitudinal axis of the above-mentioned elongated lead wire body, as described in item 138, for the electrical sensing / stimulating device. (Item 167) One or more of the above-mentioned tissue attachment members are tissue attachment members comprising a curved loop, as described in item 138, in the electrosensing / stimulating device. (Item 168) The electrical sensing / stimulating device according to item 138, wherein two or more of the tissue attachment members described above are configured to extend from different ports of the extension lead wire body. (Item 169) The electrosensing / stimulating device described in item 167, wherein two or more of the tissue attachment members described above are fitted to be coplanar when expanded. (Item 170) The electrical sensing / stimulating device according to item 138, wherein the port through which the tissue attachment mechanism unfolds has a length that allows the extension lead wire body to move in parallel over a linear portion of one or more of the tissue attachment members. (Item 171) An electrical sensing / stimulating device according to item 169, wherein one or more of the tissue attachment members described above comprises a distal wire loop and the distal linear most distal portion of the distal wire loop. (Item 172) Two or more of the above-mentioned tissue attachment members branch off from each other by an angle of less than or equal to 270 degrees, as described in item 138 of the electrical sensing / stimulating device. (Item 173) The electrosensing / stimulating device according to item 138, comprising a hollow needle having an inner lumen through which one or more attachment elements are advanced when the at least one tissue attachment member is deployed. (Item 174) An electrical sensing / stimulating device as described in item 138, further comprising a non-traumatic distal lead wire body termination. (Item 175) The electrical sensing / stimulating device according to item 173, wherein the distal end of the extension lead wire body is provided with the non-traumatic distal lead wire body termination. (Item 176) The above non-traumatic distal lead wire body termination comprises an electrical sensing / stimulating device as described in item 173, equipped with a sensing / stimulating electrode. (Item 177) The non-traumatic distal lead wire body termination has a rounded, cobra head, curved, bilaterally eccentric, or quadruple-eccentric tip, as described in item 173 for the electrical sensing / stimulator. (Item 178) The above non-traumatic distal lead wire body termination comprises a plurality of radially extending outward-facing tines, as described in item 173, for the electrical sensing / stimulating device. (Item 179) An electrical sensing / stimulating device as described in item 138, further comprising a proximal handle connected to the above-mentioned extended lead wire body. (Item 180) The electrosensing / stimulating device according to item 138, wherein the proximal handle comprises one or more controls for activating the at least one sensing / stimulating electrode, deploying or retracting the deployable / retractable displacement member, or deploying or retracting the tissue attachment mechanism, or more than one thereof. (Item 181) The electrical sensing / stimulator according to item 138, wherein the proximal handle comprises one or more displays for indicating one or more of the following: the relative position of the tissue attachment mechanism, the sensed resistance of the tissue engaged by the tissue attachment mechanism, or the amount of sensed current passing through the tissue engaged by the tissue attachment mechanism. (Item 182) The electrical sensing / stimulating device according to item 138, wherein the extended lead wire body has an internal lumen, and the electrical sensing / stimulating device further comprises a torque member located in the internal lumen and adapted to apply torque to the extended lead wire body. (Item 183) The torque member described above is fixedly attached to the extension lead wire body, and is an electrical sensing / stimulating device as described in item 181. (Item 184) The above torque member comprises a hypotube, as described in item 181, in the electrical sensing / stimulator. (Item 185) The above-mentioned molded wire is configured for placement within the internal lumen of the torque member in the electrical sensing / stimulating device as described in item 181. (Item 186) The electrical sensing / stimulator described in item 138, wherein the extended lead wire body comprises an O-ring positioned within its proximal portion, the O-ring being fitted to prevent fluid from leaking through it to the proximal portion. (Item 187) The electrical sensing / stimulating device according to item 138, wherein the plurality of tissue attachment members have extended proximal portions that are positioned within the extended lead wire body when the tissue attachment mechanism is retracted and extended. (Item 188) The above-mentioned tissue attachment member has an extended proximal portion that is housed within an outer sheath and has a shape that provides a crimping fit into the extended lead wire body, as described in item 186. (Item 189) A method for positioning an electrical sensing / stimulation device within body tissue, A step of advancing the extendable lead wire body of the electrical sensing / stimulating device so as to position the extendable lead wire body at a target site within a body cavity, wherein the internal shaping wire is positioned through the internal lumen of the extendable lead wire body to impart a predetermined shape to the extendable lead wire body, thereby facilitating the advancement of the extendable lead wire body through the body lumen. The steps include applying torque to the extended lead wire body so that at least one tissue attachment member of the electrical sensing / stimulation device is aligned with the target tissue within the target site, The steps include deploying a displacement member to bias the extension lead wire body and the at least one tissue attachment member toward the target tissue, The steps include: activating the at least one tissue attachment member so that it extends from at least one tissue anchor deployment port on the extension lead wire body into the target tissue in order to attach the distal portion of the extension lead wire body and at least one electrode of the electrical sensing / stimulation device to the target tissue; Methods that include... (Item 190) The method according to item 188, further comprising the step of verifying the proper attachment of the distal portion of the extension lead wire body to the target tissue. (Item 191) The method according to item 189, wherein the step of verifying the proper attachment of the distal portion of the extension lead wire body to the target tissue includes the step of imaging the body cavity in which the extension lead wire body is positioned using a fluorescence microscope. (Item 192) The method according to item 190, wherein the step of imaging the body cavity with a fluorescence microscope includes the step of identifying one or more radiopaque markers connected to one or more of the extension lead wire body, the at least one tissue attachment member, or the displacement member. (Item 193) The method according to item 188, further comprising the step of sensing physiological parameters using at least one electrode attached to the target tissue. (Item 194) The method according to item 188, further comprising the step of stimulating the target tissue using at least one of the electrodes described above. (Item 195) The method according to item 188, further comprising the step of crushing the displacement member and retracting the at least one tissue attachment member after attachment to the target tissue, so as to release the distal portion of the extension lead wire body and the at least one electrode from attachment to the target tissue. (Item 196) The method according to item 188, wherein the step of advancing the extension lead wire body includes the step of positioning an internal shaping wire through the internal lumen of the extension lead wire body so as to impart a predetermined shape to the extension lead wire body, the predetermined shape facilitating the advancement of the extension lead wire body through the internal lumen. (Item 197) The method according to item 188, wherein the step of applying torque to the extension lead wire body includes the step of rotating a torque member disposed within the internal lumen of the extension lead wire body. (Item 198) The displacement member is deployed from the outside of the main body of the extension lead wire, as described in item 188. (Item 199) The method according to item 188, wherein the step of unfolding the displacement member includes the step of extending the displacement member. (Item 200) The method according to item 198, wherein the displacement member comprises an expandable element, and the step of unfolding the displacement member includes the step of inflating the expandable member. (Item 201) Two or more of the above-mentioned tissue attachment members are deployed from different tissue deployment ports, as described in item 198. (Item 202) The method according to item 200, wherein the two or more mounting members described above are coplanar with each other when deployed from the different organizational deployment ports described above. (Item 203) The method according to item 188, wherein at least one of the above-mentioned tissue attachment members extends from the longitudinal axis of the extended lead wire body when unfolded. (Item 204) The method according to item 188, further comprising the step of connecting the proximal portion of the extended lead wire body described above to an external generator. (Item 205) The method according to item 203, wherein the proximal portion of the extended lead wire body is connected to the external generator through a magnetic coupler. (Item 206) The method according to item 203, wherein the proximal portion of the extension lead wire body is connected to the external generator through an extension coupler adapted to extend or retract in the axial direction. (Item 207) The method according to item 188, further comprising the step of sensing the movement of the at least one tissue attachment member attached to the extension lead wire body. (Item 208) The method according to item 206, further comprising the step of displaying the detected movement on a handle connected to the extension lead wire body described above. (Item 209) The method according to item 188, wherein the body cavity is at least a portion of the right ventricle, left ventricle, right atrium, left atrium, aorta, vena cava, artery, vein, bladder, ureter, uterus, nasal cavity, oral cavity, esophagus, stomach, intestine, gallbladder, colon, or rectum. (Item 210) An electrical sensing / stimulating device for positioning at least one electrode within body tissue, An elongated lead wire body having a vertical axis and an inner lumen, Connected to the above-mentioned extended lead wire body is at least one sensing / stimulating electrode, A deployable / retractable displacement member, connected to the above-mentioned extendable lead wire body and adapted to allow the user to move or bias the above-mentioned at least one electrode in a specified direction, A tissue attachment mechanism adapted to attach the distal portion of the extension lead wire body to body tissue, wherein the tissue attachment mechanism has a retracted configuration and an extended configuration, in the retracted configuration the tissue attachment mechanism is substantially located within the at least one internal lumen, and in the extended configuration the tissue attachment mechanism extends from the longitudinal axis of the extension lead wire body to engage with body tissue. A torque member located within the inner lumen of the extension lead wire body is provided, which is adapted to apply torque to the extension lead wire body. An electrical sensing / stimulating device equipped with the following features. (Item 211) The torque member described above is fixedly attached to the extension lead wire body, and is an electrical sensing / stimulating device as described in item 209. (Item 212) The above torque member comprises a hypotube, as described in item 209, in the electrical sensing / stimulator. (Item 213) The electrical sensing / stimulating device according to item 209, wherein the extension lead wire body has one or more ports through which the tissue attachment mechanism is deployed. (Item 214) The proximal portion of the extended lead wire body described above is configured to be connected to an external generator, as described in item 209, for the electrical sensing / stimulating device. (Item 215) The electrical sensing / stimulating device according to item 214, wherein the proximal portion of the extended lead wire body is configured to be connected to the external generator through a magnetic coupler. (Item 216) The electrical sensing / stimulating device according to item 215, wherein the proximal portion of the extension lead wire body is configured to connect to the external generator through an expansion connector adapted to extend or retract in the axial direction. (Item 217) The electrical sensing / stimulating device according to item 209, wherein at least one of the sensing / stimulating electrodes is mounted covering the outer surface of the distal portion of the extension lead wire body. (Item 218) The above-mentioned electrical sensing / stimulating device according to item 209, wherein the at least one sensing / stimulating electrode comprises a first electrode and a second electrode. (Item 219) The first electrode and the second electrode described above are separated from each other axially, in the electrical sensing / stimulator as described in item 218. (Item 220) The above-mentioned deployable / retractable displacement member is positioned between the first and second electrodes in the electrical sensing / stimulator described in item 219. (Item 221) The above deployable / retractable displacement member comprises an expandable member having a crushing configuration and an expansion configuration, as described in item 209, for the electrical sensing / stimulation device. (Item 222) The expandable member described above is adapted to unfold outwards from the outside of the main body of the extendable lead wire, as described in item 221 of the electrical sensing / stimulator. (Item 223) The electrical sensing / stimulating device according to item 222, wherein the expandable member in the above-described crushing configuration does not extend from the outer surface of the elongated lead wire body. (Item 224) The electrical sensing / stimulating device according to item 222, wherein the expandable member in the above-described crushing configuration has an outer circumference larger than the outer circumference of the elongated lead wire body. (Item 225) The expandable member described above is at least partially folded in the crushed configuration, as described in item 222, for the electrical sensing / stimulator. (Item 226) The expandable member in the above-described crushing configuration has a C-shaped, E-shaped, spiral, meandering, or star-shaped cross-section, as described in item 225, for the electrical sensing / stimulating device. (Item 227) The electrical sensing / stimulating device described in item 222, further comprising a radiopaque marker mounted on the outer surface of the expandable member described above. (Item 228) The above-mentioned radiopaque marker is expandable in conjunction with an expandable marker, as described in item 227, for the electrical sensing / stimulating device. (Item 229) The above expandable element is inflatable, as described in item 227, for electrical sensing / stimulators. (Item 230) The electrical sensing / stimulating device according to item 229, wherein the extension lead wire body has an expansion lumen to provide an expansion medium for expanding the expandable element. (Item 231) The above expandable element is an electrosensing / stimulating device as described in item 227, comprising a malecot or expandable cage. (Item 232) In the above deployment configuration, the tissue attachment mechanism extends from the longitudinal axis of the extension lead wire body so as to penetrate the body tissue, as described in item 209, an electrical sensing / stimulating device. (Item 233) The above-mentioned multiple tissue attachment members are adapted to extend from the above-mentioned longitudinal axis of the above-mentioned extension lead wire body, as described in item 209, for the electrical sensing / stimulating device. (Item 234) One or more of the above-mentioned tissue attachment members are tissue attachment members comprising a curved loop, as described in item 209, in the electrosensing / stimulating device. (Item 235) The electrical sensing / stimulating device according to item 209, wherein two or more of the tissue attachment members described above are configured to extend from different ports of the extension lead wire body. (Item 236) The electrosensing / stimulating device described in item 236, wherein two or more of the tissue attachment members described above are fitted to be coplanar when expanded. (Item 237) The electrical sensing / stimulating device according to item 209, wherein the port through which the tissue attachment mechanism unfolds has a length that allows the extension lead wire body to move in parallel over a linear portion of one or more of the tissue attachment members. (Item 238) An electrical sensing / stimulating device according to item 237, wherein one or more of the tissue attachment members described above comprises a distal wire loop and the distal linear most distal portion of the distal wire loop. (Item 239) Two or more of the above-mentioned tissue attachment members branch off from each other by an angle of less than or equal to 270 degrees, as described in item 209 of the electrical sensing / stimulating device. (Item 240) The electrosensing / stimulating device according to item 209, comprising a hollow needle having an inner lumen through which one or more attachment elements are advanced when the at least one tissue attachment member is deployed. (Item 241) An electrical sensing / stimulating device as described in item 209, further comprising a non-traumatic distal lead wire body termination. (Item 242) The electrical sensing / stimulating device according to item 241, wherein the distal end of the extension lead wire body is provided with the non-traumatic distal lead wire body termination. (Item 243) The above non-traumatic distal lead wire body termination comprises an electrical sensing / stimulating device as described in item 241, equipped with a sensing / stimulating electrode. (Item 244) The non-traumatic distal lead wire body termination has a rounded, cobra head, curved, bilaterally eccentric, or quadruple-eccentric tip, as described in item 241, for the electrical sensing / stimulator. (Item 245) The above non-traumatic distal lead wire body termination comprises a plurality of radially extending outward-facing tines, as described in item 241, for the electrical sensing / stimulating device. (Item 246) An electrical sensing / stimulating device as described in item 209, further comprising a proximal handle connected to the above-mentioned extended lead wire body. (Item 247) The electrosensing / stimulating device according to item 209, wherein the proximal handle comprises one or more controls for activating the at least one sensing / stimulating electrode, deploying or retracting the deployable / retractable displacement member, or deploying or retracting the tissue attachment mechanism, or more than one thereof. (Item 248) The electrical sensing / stimulator according to item 209, wherein the proximal handle comprises one or more displays for indicating one or more of the following: the relative position of the tissue attachment mechanism, the sensed resistance of the tissue engaged by the tissue attachment mechanism, or the amount of sensed current passing through the tissue engaged by the tissue attachment mechanism. (Item 249) The electrical sensing / stimulating device as described in item 1, wherein the extended lead wire body comprises an O-ring positioned within its proximal portion, the O-ring being fitted to prevent fluid from leaking through it to the proximal portion. (Item 250) The electrical sensing / stimulating device according to item 1, wherein the plurality of tissue attachment members have an extended proximal portion that is positioned within the extended lead wire body when the tissue attachment mechanism is retracted and extended. (Item 251) A method for positioning an electrical sensing / stimulation device within body tissue, The steps include: advancing the extension lead wire body of the electrical sensing / stimulating device so that it is positioned at a target site within the body cavity; The steps include applying torque to the extension lead wire body and applying torque to a torque member positioned inside the inner lumen of the extension lead wire body so as to align at least one tissue attachment member of the electrical sensing / stimulation device with the target tissue within the target site, The steps include deploying a displacement member to bias the extension lead wire body and the at least one tissue attachment member toward the target tissue, The steps include: activating the at least one tissue attachment member so that it extends from at least one tissue anchor deployment port on the extension lead wire body into the target tissue in order to attach the distal portion of the extension lead wire body and at least one electrode of the electrical sensing / stimulation device to the target tissue; Methods that include... (Item 252) The method according to item 251, further comprising the step of verifying the proper attachment of the distal portion of the extended lead wire body to the target tissue. (Item 253) The method according to item 252, wherein the step of verifying the proper attachment of the distal portion of the extension lead wire body to the target tissue includes the step of imaging the body cavity in which the extension lead wire body is positioned using a fluorescence microscope. (Item 254) The method according to item 253, wherein the step of imaging the body cavity with a fluorescence microscope includes the step of identifying one or more radiopaque markers connected to one or more of the extension lead wire body, the at least one tissue attachment member, or the displacement member. (Item 255) The method according to item 251, further comprising the step of sensing physiological parameters using at least one electrode attached to the target tissue. (Item 256) The method according to item 251, further comprising the step of stimulating the target tissue using at least one of the electrodes described above. (Item 257) The method according to item 251, further comprising the step of crushing the displacement member and retracting the at least one tissue attachment member after the attachment to the target tissue so as to release the attachment of the distal portion of the extension lead wire body and the at least one electrode from the target tissue. (Item 258) The method according to item 251, wherein the displacement member is deployed from the outside of the extension lead wire body. (Item 259) The method according to item 251, wherein the step of deploying the displacement member includes the step of expanding the displacement member. (Item 260) The method according to item 260, wherein the displacement member is expanded into a shape that conforms to the shape of the body cavity. (Item 261) The method according to item 260, wherein the displacement member includes an expandable element, and the step of deploying the displacement member includes the step of inflating the expandable member. (Item 262) The method according to item 261, wherein two or more of the plurality of tissue attachment members are deployed from different tissue deployment ports. (Item 263) The method according to item 262, wherein the two or more attachment members are in the same plane with each other when deployed from the different tissue deployment ports. (Item 264) The method according to item 251, wherein the at least one tissue attachment member extends from the longitudinal axis of the extension lead wire body when deployed. (Item 265) The method according to item 251, further comprising the step of connecting the proximal portion of the extension lead wire body to an external generator. (Item 266) The method according to item 265, wherein the proximal portion of the extension lead wire body is connected to the external generator through a magnetic coupler. (Item 267) The method according to item 265, wherein the proximal portion of the elongated lead wire body is connected to the external generator through an expansion coupler adapted to extend or contract axially. (Item 268) The method according to item 251, further comprising the step of sensing movement of the at least one tissue attachment member attached to the elongated lead wire body. (Item 269) The method according to item 268, further comprising the step of displaying the sensed movement on a handle connected to the elongated lead wire body. (Item 270) The method according to item 269, wherein the body cavity is at least partially one of a right ventricle, a left ventricle, a right atrium, a left atrium, an aorta, a vena cava, an artery, a vein, a bladder, a ureter, a uterus, a nasal cavity, an oral cavity, an esophagus, a stomach, an intestine, a gallbladder, a colon, or a rectum.

Brief Description of the Drawings

[0107] Note that the drawings are not to scale and are intended only as an aid in conjunction with the description of the embodiments for carrying out the following invention. In the drawings, the same reference numerals identify similar elements or acts. The sizes and relative positions of the elements in the drawings are not necessarily drawn to scale. For example, the shapes and angles of various elements may not be drawn to scale, and some of these elements may be arbitrarily enlarged and positioned to improve the readability of the drawings. Further, the particular shapes of the elements as drawn are not intended to convey any information regarding the actual shapes of the particular elements and are merely selected to facilitate recognition within the drawings. A better understanding of the features and advantages of the present disclosure will be obtained by referring to the following description of the embodiments for carrying out the invention, which describes illustrative embodiments in which the principles of the present disclosure are utilized, and the accompanying drawings.

[0108] [Figure 1a] FIG. 1a shows a side view of a distal lead wire section of an electrical sensing / stimulation device in which the tissue attachment member has been retracted and the balloon has been deflated, according to many embodiments.

[0109] [Figure 1b] Figure 1b shows a side view of the distal lead wire section of the electrical sensing / stimulating device shown in Figure 1a, with the tissue attachment member deployed and the balloon inflated.

[0110] [Figure 2a] Figure 2a shows a side view of the distal lead wire section of the electrical sensing / stimulating device in Figure 1a, showing a longitudinal cutout through which the balloon expands when inflated.

[0111] [Figure 2b] Figure 2b shows a top view of the distal lead wire body of Figure 2a, with a small cutout for the passage of the ring electrode wire and tissue attachment member.

[0112] [Figure 2c] Figure 2c shows a perspective view of the end of the distal lead wire body of Figure 2a, which contains a main central lumen in which a balloon is mounted, two smaller circular lumens each housing a ring electrode wire, and a small oval lumen in which the tissue attachment member moves in parallel.

[0113] [Figure 3-1] Figures 3a–3c show balloons of the electrical sensing / stimulating device of Figure 1a mounted on a D-shaped longitudinal element to generate an inflatable element cartridge, according to many embodiments. This subassembly may be inserted into the main D-shaped lumen of the distal lead wire body. Figure 3a shows a side perspective view of the inflatable element cartridge.

[0114] [Figure 3-2]Figures 3a - 3c show balloons of the electrical sensing / stimulation device of FIG. 1a mounted on a D-shaped longitudinal element to create an expandable element cartridge, according to many embodiments. This subassembly may be inserted into the main D-shaped lumen of the distal lead body. FIG. 3a' shows a cross-sectional view of an expandable element cartridge with a balloon in a collapsed configuration. FIG. 3a'' shows a cross-sectional view of an expandable element cartridge with a balloon in an expanded configuration. FIG. 3b shows a side view of an expandable element cartridge separated from the distal lead body. FIG. 3c shows a side view of an expandable element cartridge connected to the distal lead body.

[0115] [Figure 4-1] Figures 4a - 4d show another expandable displacement member mounted within the distal lead body of an electrical sensing / stimulation device, according to many embodiments. FIG. 4a shows a side view of the distal lead body. FIG. 4b shows a side view of the expandable displacement member. FIG. 4c shows a side view of the expandable displacement member separated from the distal lead body.

[0116] [Figure 4-2] Figures 4a - 4d show another expandable displacement member mounted within the distal lead body of an electrical sensing / stimulation device, according to many embodiments. FIG. 4d shows a side view of the expandable displacement member connected to the distal lead body.

[0117] [Figure 5-1] Figures 5a - 5e depict another expandable displacement member mounted on a cartridge in a spiral pattern and that may be mounted within the distal lead body of an electrical sensing / stimulation device, according to many embodiments. FIG. 5a shows a side view of the cartridge. FIG. 5b shows a side view of the expandable displacement member.

[0118] [Figure 5-2]Figures 5a–5e depict other inflatable displacement members, which, according to many embodiments, are mounted on a cartridge in a helical configuration and can be mounted within the distal lead wire body of an electrical sensing / stimulation device. Figure 5c shows a side view of a cartridge-mounted inflatable displacement member. Figure 5d shows a side view of a cartridge-mounted inflatable displacement member separated from the distal lead wire body. Figure 5e shows a side view of a cartridge-mounted inflatable displacement member connected to the distal lead wire body.

[0119] [Figure 6-1] Figure 6a shows a perspective view of the insertion / insertion of a tissue attachment member into the oval channel of the distal lead wire body of an electrical sensing / stimulating device, according to many embodiments.

[0120] [Figure 6-2] Figure 6a' shows a perspective view of these tissue attachment members, which can be deployed by retracting the actuation wire. Figure 6b shows a magnified perspective view of the insertion / insertion of the tissue attachment member into the oval channel of the distal lead wire body.

[0121] [Figure 6-3] Figure 6c shows a cross-sectional view of the positioning of the tissue attachment member within the oval channel of the distal lead wire body, the mounting positions of the electrode and associated electrode wire, and the position of the internal torque control member.

[0122] [Figure 7-1] Figure 7a shows a perspective view of the top of the distal lead wire body of an electrical sensing / stimulating device, illustrating the tissue attachment members in their receding linear configuration within the oval lumen, and the ring electrode wires within each lumen, according to many embodiments.

[0123] [Figure 7-2]Figure 7b shows a perspective view of a partial assembly of the distal lead section of Figure 7a, showing the tissue anchors in their deployed configuration. Figure 7b' shows a side view of the distal lead section of Figure 7a, showing the distal lead section with tissue anchors in their retracted configuration, and various shapes of electrodes that provide radiographic orientation for the distal lead section.

[0124] [Figure 8-1] Figures 8a-8d depict various distal tips of the distal lead section according to many embodiments. Figure 8a shows a perspective view of the distal tip.

[0125] [Figure 8-2] Figures 8a-8d depict various distal ends of the distal lead section according to many embodiments. Figure 8b shows a perspective view of another distal end. Figure 8c shows a perspective view of another distal end. Figure 8d shows a perspective view of another distal end.

[0126] [Figure 9a] Figures 9a, 9b, and 9c show side views of torque control members according to several embodiments. [Figure 9b] Figures 9a, 9b, and 9c show side views of torque control members according to several embodiments. [Figure 9c] Figures 9a, 9b, and 9c show side views of torque control members according to several embodiments.

[0127] [Figure 10] Figure 10 shows side views of lead wire handles and operating / locking mechanisms according to several embodiments.

[0128] [Figure 10a] Figure 10a shows a side view of a lead wire handle and rotation mechanism according to several embodiments.

[0129] [Figure 10b] Figure 10b shows an enlarged view of the rotating faceplate of the lead wire handle shown in Figure 10a.

[0130] [Figure 10c] Figure 10c shows cross-sectional views of lead wire handles and rotating mechanisms according to several embodiments.

[0131] [Figure 10d] Figure 10d shows an enlarged view of the rotation mechanism in Figure 10c.

[0132] [Figure 11a] Figure 11a shows a perspective view of the distal lead wire compartment of an electrical sensing / stimulating device, in many embodiments, where tissue attachment members deployed from a common port are separated from each other by approximately 90°.

[0133] [Figure 11b] Figure 11b shows a perspective view of the distal lead wire compartment of an electrical sensing / stimulating device, in many embodiments, where tissue attachment members deployed from a common port are separated from each other by more than 90°.

[0134] [Figure 11c] Figure 11c shows a perspective view of the distal lead wire compartment of an electrical sensing / stimulating device, in many embodiments, where tissue attachment members deployed from a common port are separated from each other by less than 90°.

[0135] [Figure 11d] Figure 11d shows the tissue mounting member assembly of Figures 11a-11c.

[0136] [Figure 11e] Figure 11e shows a side view of the distal lead wire section of an electrical sensing / stimulating device, in which the tissue attachment member is oriented toward the lead wire body, according to many embodiments.

[0137] [Figure 11f] Figure 11f shows a front view of the distal lead wire section in Figure 11e.

[0138] [Figure 12a]Figure 12a shows a perspective view of the distal lead wire section of an electrical sensing / stimulating device, in many embodiments, where tissue attachment members deployed from a common port are separated axially / longitudinally but remain in the same plane.

[0139] [Figure 12b] Figure 12b shows a perspective view of the distal lead wire section of an electrical sensing / stimulating device, according to many embodiments, in which the tissue attachment member unfolds from a common port and has a decreasing end loop radius.

[0140] [Figure 12c] Figure 12c shows a perspective view of a tissue attachment assembly for an electrical sensing / stimulating device, according to many embodiments, in which the tissue attachment members have end loops with a radius that decreases along their length.

[0141] [Figure 13a] Figure 13a shows a perspective view of the distal lead wire section of an electrical sensing / stimulating device, in many embodiments, where the tissue attachment member is unfolded from the extension common port and translated parallel to the distal end of the port.

[0142] [Figure 13b] Figure 13b shows a perspective view of the distal lead wire section of Figure 13a, with the tissue attachment member moved parallel to the proximal end of the port.

[0143] [Figure 14] Figure 14 shows a perspective view of the distal lead wire section of an electrical sensing / stimulating device, in many embodiments, where the tissue attachment member unfolds from an elongation common port and has a linear end.

[0144] [Figure 15a] Figure 15a shows a perspective view of the distal lead wire section of an electrical sensing / stimulating device, in many embodiments, in which a tissue attachment member is unfolded from an extension common port and comprises a hollow tube.

[0145] [Figure 15b]Figure 15b shows a perspective view of the distal lead wire section of Figure 15a, which is unfolded from the tissue attachment member on which the spiral anchor wire is deployed.

[0146] [Figure 15c] Figure 15c shows a perspective view of the distal lead wire section of Figure 15a, where the spiral anchor wire is deployed and the tissue attachment member is retracted.

[0147] [Figure 16a] Figure 16a shows a cross-sectional view of the distal lead wire compartment of an electrically sensing / stimulating device inserted into the ventricle, with a large-diameter biasing loop deployed, according to many embodiments.

[0148] [Figure 16b] Figure 16b shows a cross-sectional view of the distal lead wire section of Figure 16a, where a large-diameter biasing loop is deployed and the anchor wire extends from the loop.

[0149] [Figure 16c] Figure 16c shows the large biasing loop and anchor wire from Figure 16a.

[0150] [Figure 17a] Figure 17a shows a “snap-in” tissue attachment member assembly in many embodiments.

[0151] [Figure 17b] Figure 17b shows the "inserted" tissue attachment assembly and the distal lead wire compartment of the electrical sensing / stimulating device in Figure 17a.

[0152] [Figure 18-1] Figures 18a, 18b, 18c, 18d, 18e, 18f, 18g, 18h, and 18i show various distal tips of distal lead wire sections having integrated electrodes according to many embodiments. [Figure 18-2]Figures 18a, 18b, 18c, 18d, 18e, 18f, 18g, 18h, and 18i show various distal tips of distal lead wire sections having integrated electrodes according to many embodiments. [Figure 18-3] Figures 18a, 18b, 18c, 18d, 18e, 18f, 18g, 18h, and 18i show various distal tips of distal lead wire sections having integrated electrodes according to many embodiments.

[0153] [Figure 19a] Figure 19a shows a cross-sectional view of the apex of the patient's heart.

[0154] [Figure 19b] Figure 19b shows a cross-sectional view of the right ventricle obtained from line 19B-19B in Figure 19a.

[0155] [Figure 19c] Figure 19c shows a cross-sectional view of the distal lead wire compartment of an electrical sensing / stimulating device, in many embodiments, where a molded expandable displacement member is expanded to conform to the shape of the right ventricular cavity.

[0156] [Figure 19d] Figure 19d shows a cross-sectional view of the distal lead wire section in Figure 19c, where the expandable displacement member has been crushed.

[0157] [Figure 19e] Figure 19e shows a side view of the distal lead wire section of Figure 19c, with the expandable displacement member crushed.

[0158] [Figure 19f] Figure 19f shows a cross-sectional view of the distal lead wire section of Figure 19c with the expandable displacement member expanded.

[0159] [Figure 19g] Figure 19g shows a side view of the distal lead wire section of Figure 19c with the expandable displacement member extended.

[0160] [Figure 19h] Figure 19h shows a cross-sectional view of the distal lead wire section of Figure 19c when a molded expandable displacement member is expanded, illustrating how varying the wall thickness of the expandable displacement member at a specific location can result in a desired shape when expanded.

[0161] [Figure 20a] Figure 20a shows a cross-sectional view of the distal lead wire section of an electrical sensing / stimulating device, in which an expandable displacement member is circularly compressed within the lead wire body, according to many embodiments.

[0162] [Figure 20b] Figure 20b shows a cross-sectional view of the distal lead wire section of an electrical sensing / stimulating device, in many embodiments, where the expandable displacement member is compressed into a C-shape within the lead wire body.

[0163] [Figure 20c] Figure 20c shows a cross-sectional view of the distal lead wire section of an electrical sensing / stimulating device, in many embodiments, where the expandable displacement member is crushed into an inward-curving C-shape, with the end of "C" curling inward within "C", and the balloon is nested within the lead wire body.

[0164] [Figure 20d] Figure 20d shows a cross-sectional view of the distal lead wire section of an electrical sensing / stimulating device, in which an expandable displacement member is helically compressed within the lead wire body, according to many embodiments.

[0165] [Figure 20e] Figure 20e shows a cross-sectional view of the distal lead wire section of an electrical sensing / stimulating device, in which the expandable displacement member is compressed into a meandering shape within the lead wire body, according to many embodiments.

[0166] [Figure 21a] Figure 21a shows a side view of the distal lead wire section of an electrical sensing / stimulating device, in which an expandable displacement member is axially compressed within the lead wire body, according to many embodiments.

[0167] [Figure 21b] Figures 21b and 21c show side views of the expandable displacement member of Figure 21a, which is partially expanded outward and shows its axial fold. [Figure 21c] Figures 21b and 21c show side views of the expandable displacement member of Figure 21a, which is partially expanded outward and shows its axial fold.

[0168] [Figure 22a] Figure 22a shows a side view of a meandering marker for an expandable displacement member of the distal lead wire section of an electrical sensing / stimulating device in a crush configuration, according to many embodiments.

[0169] [Figure 22b] Figure 22b shows a side view of the meandering marker in Figure 22a in the extended configuration.

[0170] [Figure 22c] Figure 22c shows a side view of the meandering marker of Figure 22a mounted on the expandable displacement member in both of their crushing configurations.

[0171] [Figure 22d] Figure 22d shows a top view of the meandering marker of Figure 22a mounted on the expandable displacement member in both of their crushing configurations.

[0172] [Figure 22e] Figure 22e shows a side view of the meandering marker of Figure 22a mounted on the expandable displacement member in both of those extended configurations.

[0173] [Figure 22f] Figure 22f shows a top view of the meandering marker of Figure 22a mounted on the expandable displacement member in both of those extended configurations.

[0174] [Figure 22g]Figure 22g shows a side view of an arrow-shaped meandering marker for an expandable displacement member of the distal lead wire section of an electrical sensing / stimulating device in a crush configuration, according to many embodiments.

[0175] [Figure 22h] Figure 22h shows a side view of the arrow-shaped meandering marker in Figure 22g in the extended configuration.

[0176] [Figure 22i] Figure 22i shows a top view of the arrow-shaped meandering marker of Figure 22g mounted on the expandable displacement member in both of those extended configurations.

[0177] [Figure 22j] Figure 22j shows a top view of the arrow-shaped meandering markers of Figure 22g mounted on the expandable displacement members in both of their crushing configurations.

[0178] [Figure 23a] Figure 23a shows a side view of the distal lead wire section of an electrical sensing / stimulating device with a mechanically expandable displacement member in a crush configuration, according to many embodiments.

[0179] [Figure 23b] Figure 23b shows a side view of the distal lead wire section of the electrical sensing / stimulating device of Figure 23a with a mechanically expandable displacement member in the expanded configuration.

[0180] [Figure 23c] Figure 23c shows a cross-sectional view of the distal lead wire section of the electrical sensing / stimulating device in Figure 23a, obtained through line 23C-23C in Figure 23b.

[0181] [Figure 24a] Figure 24a shows an electrical sensing / stimulation device and an external generator that can be connected thereto, according to several embodiments.

[0182] [Figure 24b]Figure 24b shows an electrically sensing / stimulating device and an external generator that can be connected to it via a magnetic connection hub, according to many embodiments.

[0183] [Figure 24c] Figure 24c shows the electrically sensing / stimulating device, external generator, and magnetic connection hub from Figure 24b, all connected together.

[0184] [Figure 25a] Figure 25a shows top views of an electrical sensing / stimulation device, an external generator, and a retractable extension cord adapter according to several embodiments.

[0185] [Figure 25b] Figure 25b shows a top view of the retractable extension cord adapter of Figure 25a in an axial retraction configuration.

[0186] [Figure 25c] Figure 25c shows a top view of the retractable extension cord adapter of Figure 25a in an axial extension configuration.

[0187] [Figure 25d] Figure 25d shows a top view of the retractable extension cord adapter shown in Figure 25a.

[0188] [Figure 25e] Figure 25e shows a side view of the retractable extension cord adapter shown in Figure 25a.

[0189] [Figure 25f] Figure 25f shows an exploded side view of the retractable extension cord adapter shown in Figure 25a.

[0190] [Figure 25g] Figure 25g shows a top view of an electrically sensing / stimulating device with an integrated retractable extension cord and an external generator, according to many embodiments.

[0191] [Figure 26a]Figure 26a shows a schematic diagram of detecting the movement of a tissue attachment member of an electrical sensing / stimulating device based on the detection of current changes, according to many embodiments.

[0192] [Figure 26b] Figure 26b shows another schematic diagram for detecting the movement of a tissue attachment member of an electrical sensing / stimulation device based on current changes, according to many embodiments.

[0193] [Figure 26c] Figure 26c shows a side view of the LCD display of the handle of an electrically sensing / stimulating device capable of detecting the movement of a tissue attachment member, according to many embodiments.

[0194] [Figure 26d] Figure 26d shows a side view of the LCD display of the handle of an electrically sensing / stimulating device capable of detecting the movement of a tissue attachment member, according to many embodiments.

[0195] [Figure 26e] Figure 26e shows a schematic diagram of the circuit of the handle in Figure 26d, derived from the current sensing elements in Figures 27a and 27b.

[0196] [Figure 27a] Figure 27a shows a perspective view of the distal lead wire section of an electrical sensing / stimulating device with a torque control member and a segmented moldable member, according to several embodiments.

[0197] [Figure 27b] Figure 27b shows an enlarged view of the torque control member in Figure 27a. [Modes for carrying out the invention]

[0198] This disclosure describes devices and methods for the delivery and implantation of electrodes or electrode arrays within body cavities. Such electrodes or electrode arrays may generally be referred to as sensing or pacing leads. Such leads are described herein for use in cardiac applications, i.e., for the placement of electrodes or electrode arrays within cardiac chambers. However, the devices and methods described herein are not limited in this respect and may be applied to any cavity or blood vessel of the body accessible via a catheter system. The vascular access site for lead introduction may, in examples, be, but is not limited to, the internal jugular vein, femoral vein, or subclavian vein. While electrodes or electrode arrays may be used to sense the inherent electrical activity of body tissue, electrodes or electrode arrays may also be used to deliver electrical stimulation to body tissue when the electrodes or electrode arrays are connected to either an implanted or external electrical pulse generator (e.g., via an adapter that can be connected to the proximal pin connector of the lead, such as using an industry standard IS-1 type connector or equivalent).

[0199] Figures 1a and 1b show the basic elements of a distal lead section 100, which may include an extendable lead body 120, a displacement mechanism comprising an eccentric expandable displacement element 320 (i.e., the expandable displacement element 320 may extend laterally from one outside of the extendable lead body 120, and may be tubular in shape), sensing / stimulating electrodes 131 and 132, tissue attachment members 141 and 142, and a non-traumatic tip 110. In some embodiments, the lead body 120 may have a nominal diameter of 0.080 inches and a working length of 110 cm (such as measured along the lead body from the distal tip of the device to the handle), but both are not limited thereto and may be adjusted to fit any specific anatomical configuration. As described herein, each element of the lead may have various designs and forms, but all operate in a manner that provides the lead with the same basic operating characteristics. In some embodiments, element 142 may exit the extension body from the same location as 141, or vice versa. Also in some embodiments, one or more tissue attachment members may exit the extension body 120 from the same axial location.

[0200] Lead wire body

[0201] The lead wire body 120 may include an extruded thermoplastic polymer material having one or more lumens. In some embodiments, the material may be, but is not limited to, Pellethane(R) having a Shore hardness of 55D or 63D. Thermosetting polymers such as ricone may also be used. The polymer may contain radiopaque additives such as barium sulfate or bismuth to provide a fluoroscopic image of the lead wire body when the device is imaged during the implantation procedure using an X-ray fluoroscopy system. Figures 2a-2c show a lead wire body 120 incorporating one or more lumens used for communication from the proximal end to the distal end of the lead wire body. In some embodiments, one or more lumens communicate to the displacement member 320, to electrodes 131, 132, and to tissue attachment members 141, 142. The distal end of the lead wire body may have a curve that can be manipulated by the user and may terminate at a non-traumatic tip 600 or another non-traumatic tip, embodiments of which are shown in Figures 8a-8d and 18a-18i.

[0202] Torque control member

[0203] Depending on the durometer and precise cross-sectional shape of the lead wire body, the lead wire body may or may not have sufficient torque control required to align the distal lead wire section 100 with the target tissue during the implantation procedure. To provide increased torque control to the lead wire body 120, torque control members 710, 720, and 730 may be machined into the lead wire body 120. As depicted in Figures 6c, 7a, and 9a–9c, the torque control members 710, 720, and 730 may be located inside the length of the main central lumen 220 of the lead wire body 120. The torque control members may comprise a reverse-winding coil configuration in which a first inner coil 712, wound in a first direction, is wrapped by an outer coil 714, wound in the opposite direction. These coil configurations may also be referred to as “dual” coil assemblies. These coil assemblies can generally provide slightly better torque control because the assembly can apply torque in a direction that will tighten the outer coil over the inner coil. Another coil configuration 720, referred to as a “triple” coil assembly, may include a third coil 722 such that the inner and outer coils are wound in the same direction, and the central coil is wound in the opposite direction. Generally, triple coil assemblies can provide better torque control when the coils are rotated around their axis in either direction. The third type of torque control member 730 may be a braided catheter shaft, a composite structure well known in the medical device industry, shown in Figure 9c, which comprises an inner layer of a polymer, such as Pellethane or nylon, surrounded by a braided tube typically made of stainless steel wire, and then encased in an outer layer of a polymer such as Pellethane or nylon. Many suitable polymers may be specified for the inner and outer layers, and may also include polymid, silicone, or other thermoplastic or thermosetting polymers. The braided wire may be, but is not limited to, stainless steel, for example, Nitinol, MP35N or 35NLT (available, for example, from Fort Wayne Metals (Fort Wayne, IN)), or other suitable metals or polymers such as Kevlar.The diameter of the braided wire can vary between 0.001 inches and 0.010 inches, but is not limited thereto.

[0204] The double coil assembly 710, triple coil assembly 720, or braided catheter shaft 730 may be inserted and attached into the main central lumen 220 by thermally melting the lead wire body material 120 into the torque control member 710, 720, or 730 by simultaneously extruding the lead wire body together with an adhesive or braid, but the method of attachment is not limited thereto. Attachment to the main central lumen 220 may occur at various locations, such as along the entire length of the lead wire body 120, at periodic intervals within the lead wire body, or at specific predetermined points along the lead wire body 120. Attaching the torque control members 710, 720, or 730 to the main central lumen 220 of the lead wire body 120 allows them to be unified so that they can be moved as a single assembly. Both the proximal end of the lead wire body 120 and the proximal end of the torque control member 710, 720, or 730 can be terminated together and attached to the distal section of the handle. Therefore, when the handle is rotated, the torque control member 710, 720, or 730 and the lead wire body 120 can move in conjunction. Further torque members and torque control members are described below and herein.

[0205] Displacement member

[0206] The main central lumen 220 of the lead wire body 120 terminates distally in the displacement member 320. The main central lumen 220 of the lead wire body 120 extends inward along the length of the lead wire body and terminates proximal in the expansion port 802, allowing the device connection to pressurize air or other expansion medium within the lumen 220 and the expandable displacement member 320.

[0207] As shown in Figures 1b, 3a-3c, and 4a-4d, the displacement member may include an expandable member 320 that can be substantially mounted within the main central lumen 220 of the lead wire body 120. The expandable displacement member 320 may generally comprise a tubular structure (tube) and may be constructed of an elastomer polymer, a thin-walled non-flexible or semi-flexible polymer. In many embodiments, the expandable displacement member 320 may be inflated to expand the displacement member 320. When inflated with air, CO2, a liquid (e.g., water, iodine contrast agent / aqueous solution, or other suitable biocompatible fluid), or other expansion medium, the expandable displacement member 320 will expand and deploy through a deployment window 210 cut into the central main lumen 220 of the lead wire body 120. Because the expandable displacement member 320 can deploy through a deployment window 210 on one side of the lead wire body, the expansion of the expandable displacement member 320 may be eccentric with respect to the lead wire body 120 itself. The position of the deployment window 210 may be substantially opposite to the position of the tissue attachment member deployment port 240 (e.g., directly opposite or oppositely outward), but the deployment window 210 may be positioned at any angular position and any axial and / or longitudinal position relative to the tissue attachment member deployment port 240. In some embodiments, two or more tissue attachment members 141, 142 may be deployed from a single tissue attachment member deployment port 240. In some embodiments, the displacement member 320 may comprise an expandable metal or polymer scaffold, i.e., a tubular mesh that, in some embodiments, can expand radially when shortened along their axes. Other embodiments of expandable members are shown in U.S. Patent Application No. 13 / 219,874 by Garai et al., the contents of which are fully incorporated herein by reference.

[0208] In some embodiments, the expandable displacement member 320 may be made of an elastomer polymer material. Other suitable materials may be used that can provide the degree of expansion required by the size and shape of the anatomical structure in which the lead wire will be positioned and attached to the tissue. When inflated, the expandable displacement member 320 can expand and unfold through the unfolding window 210, and when deflated, the expandable displacement member 320 can deflate and re-establish its mounting position within the main central lumen 220 of the lead wire body 120. When properly positioned within a body cavity, the expansion of the expandable displacement member 320 initiates contact and exerts force on the wall of the body cavity, thus displacing the lead wire body 120, associated electrodes 131, 132, and tissue attachment deployment port 240 in different (e.g., opposite) directions toward the tissue targeted for contact with electrodes 131, 132, and the tissue attachment deployment port 240 can be oriented to face the target tissue for deployment of tissue attachment members 141, 142 into the target tissue for attachment to the tissue. The expandable displacement member 210 may also be constructed of a non-flexible or semi-flexible polymer or other material suitable for expansion. In this configuration, the expandable displacement member 320 may be folded in a manner that substantially allows its placement within the lead wire body, and upon contraction, the expandable displacement member may fold again to return to its original non-expanded configuration.

[0209] As shown in Figures 3a-3c, the expandable displacement member 320 can, in an embodiment, be mounted over a hollow D-shaped longitudinal element 310, which may be a coil, polymer extruded, or injection-molded component. As shown in Figure 3a, when mounted in this manner, the D-shaped longitudinal element and the expandable displacement member 320 form a cartridge 300. In this configuration, the circumference of the outer diameter of the expandable displacement member 320 will be smaller than the circumference of the inner diameter of the lumen 220 in which the expandable displacement member 320 resides. The expandable member cartridge 300 is inserted into the distal end of the central main lumen 220, positioned in the center of the deployment window 210, and can be fixed in place at its proximal and distal ends within the central main lumen 220 using adhesive or thermal bonding. The proximal end of the cartridge may be open and can communicate with the main central lumen 220 of the lead wire body 120, and thus expand as described above.

[0210] As shown in Figures 4a-4c, the expandable displacement member 420 may also comprise a tubular structure (tube) and may be fabricated using a material similar to that described above with reference to Figure 3a. However, in the embodiment shown in Figures 4a-4c, the expandable displacement member 420 may be folded to form a “C-shaped” nesting configuration. The advantage of this configuration is that, with respect to a given lumen 410 in which the expandable displacement member 320 is located inside, the circumference of the folded tube that creates the nesting configuration may be larger than the inner circumference of the lumen 410. Considering the same material and wall thickness of the tube for fabricating the expandable displacement members 320 and 420, when expanded, the expandable displacement member 420 in Figure 4 may be able to expand further than the expandable displacement member 320, as shown in Figure 3, due to the fact that the effective circumference of the expandable displacement member 420 is larger than that of the expandable displacement member 320.

[0211] A configuration in which an expandable displacement member 320 or 420 is mounted within the lumen 220 of the lead wire body 120 allows the expandable member 320, 420 to be deployed through a deployment window 210. The longitudinal and circumferential dimensions of the deployment window 210 may be adjusted to be deemed appropriate for controlling the deployed dimensions of the displacement member by controlling the volume of air or fluid within the expandable displacement member, for example, in accordance with anatomical requirements that may be designed so that the lead wire operates inside. Thus, extending the deployment window 210 can increase the length of the deployed displacement member 320, 420, while increasing or decreasing the circumferential dimensions of the deployment window can increase or decrease the amount of expansion of the expandable displacement member 320, 420, and therefore its diameter. The expansion of the C-shaped, foldable, expandable displacement member 420 may be achieved via a small connecting tube 425, the distal end of which is located within the lumen of the expandable displacement member 420, and the proximal end of which communicates with the main central lumen 220 of the lead wire body 120. Both ends of the C-shaped balloon may be sealed to provide a sealed, expandable balloon cartridge. In addition, the connecting tube 425 may be sealed to the distal end of at least one embodiment of the torque member 730 so that the torque member 730 can serve as an expansion lumen for the balloon cartridge. In this case, the torque member 730 may be a braided stainless steel wire, coil, or polymer laminated shaft of a similar structure and will have a continuous wall structure capable of holding pressure.

[0212] Figures 20a–20e show cross-sectional views of the distal lead wire compartment 100 or distal lead wire compartment 100a (discussed below and further herein). As shown in Figures 20a–20e, the expandable displacement element 320 may be folded in different ways within the body of the distal lead wire compartment 100 or 100a.

[0213] As shown in Figure 20a, the expandable displacement element 320 may be circular or elliptical when compressed within the distal lead wire compartment 100 or 100a. The expandable displacement element 320 may have a circumference 326a smaller than the circumference of the distal lead wire compartment 100 or 100a, which may limit the size of the expandable displacement element 320 when expanded outward from the exit port 324 of the distal lead wire compartment 100 or 100a.

[0214] Figures 20b-20e show embodiments of other methods for nesting the expandable displacement element 320 within the distal lead wire section 100 or 100a, such as to increase the circumference of the expandable displacement element 320, so that the expandable displacement element 320 can have a larger size when extended outward from the exit port 324 of the distal lead wire section 100 or 100a, at least partially.

[0215] As shown in Figure 20b, the expandable displacement element 320 may fold into a C-shape when crushed within the distal lead wire section 100 or 100a, and may have a circumference 326b which may be larger than the circumference 326a and / or the circumference of the distal lead wire section 100 or 100a. As shown in Figure 20c, the expandable displacement element 320 may fold into an inwardly curved C-shape (i.e., the ends of the "C" are inwardly curved) when crushed within the distal lead wire section 100 or 100a, and may have a circumference 326c which may be larger than the circumference 326a and / or the circumference of the distal lead wire section 100 or 100a. As shown in Figure 20d, the expandable displacement element 320 may fold into a spiral shape when compressed within the distal lead wire compartment 100 or 100a and may have a circumference 326d which may be larger than the circumference 326a and / or the circumference of the distal lead wire compartment 100 or 100a. As shown in Figure 20e, the expandable displacement element 320 may fold into a meandering shape when compressed within the distal lead wire compartment 100 or 100a and may have a circumference 326e which may be larger than the circumference 326a and / or the circumference of the distal lead wire compartment 100 or 100a. In the embodiments shown in Figures 20a-20e, the expansion medium 322 may be provided inside the expandable displacement element 320 within the distal lead wire compartment 100 or 100a, while ambient fluid such as blood may be present outside the expandable displacement element 320.

[0216] Figures 20b–20e show that the expandable displacement element 320 may be folded around the axis or longitudinal axis of the distal lead wire compartment 100 or 100a. Alternatively, or in combination, the expandable displacement element 320 may be folded perpendicular to the axis or longitudinal axis of the distal lead wire compartment 100 or 100a, as shown in Figures 21a–21c. Figure 21a shows the expandable displacement element 320 completely compressed within the distal lead wire compartment 100 or 100a. Figures 21b and 21c show the expandable displacement element 320 partially expanded, exposing the folded portion of the expandable displacement element 320.

[0217] As shown in Figures 5a-5e, the expandable displacement member 526 may comprise a substantially tubular structure fabricated from a similar material as described in the embodiments of Figures 3 and 4. Figure 5 may demonstrate that the tubular expandable displacement member 526 may be mounted on the cartridge 500 in a helical or spiral manner. The cartridge 500 may have distal and proximal receiving channels 502, 504 for receiving and mounting the distal and proximal ends of the expandable displacement member 526. Mounting may be, but is not limited to, the use of adhesive or thermal bonding. The expandable displacement member 526 may be inflated via a small port 506 at the proximal end of the mounting cartridge 500, which communicates between the lead wire lumen 220 and the interior of the expandable displacement member 526. Thus, the length of the expandable displacement member 526 held between the distal and proximal connecting regions 502 and 504 may comprise an expandable portion of the member extending through the deployment window 210 of the lead wire body 120. The advantage provided by such an expandable displacement member 526 is that, with respect to a lead wire body 120 and deployment window 210 of a given size, the diameter of the expandable displacement member 526 tube can be increased beyond that of Figures 3 and 4. Figure 5e shows that the longitudinal axis of the expandable displacement member 526 tube is at an angle θ with respect to the lead wire body axis. Figure 5c shows the width "d" of the expandable displacement member 526 tube when flattened and mounted on the cartridge 500. By adjusting the angle θ and the length of the deployment window 210, the width of the flattened expandable displacement member 526 tube, and therefore the diameter of the tube, can be increased to provide even greater expansion of the expandable displacement member 526.

[0218] The aforementioned displacement members 320, 420, and 520 can generally be considered as single lumen tubes. However, it can be understood that any of these displacement members may be subdivided so that there may be multiple parallel lumens, as seen in the cross-section. One such embodiment is shown in the cross-section of Figure 3a', where two or more lumens 330 may coincide along the length of the displacement member. Figure 3a' shows a cross-section of the displacement member 325 in the non-expanded state, and Figure 3a'' shows the displacement member in the expanded state. In this configuration, the displacement member may or may not be mounted on a cartridge. The expanded member may simply be inserted into the lead wire body extrusion 220 and attached in position to the lumen using the method previously described. Under expansion, each lumen may expand, and a specific cross-sectional geometric configuration may be generated as shown in Figure 3''. Thus, a shape may be generated that closely conforms to an anatomical cavity in which the displacement member can expand internally, so that the expanded displacement member can self-align with the anatomical space.

[0219] The expandable displacement members 320, 420, or 520 may also incorporate a fluorescent marker printed on its surface, either as an expandable marker or as a local marker. In the case of an expandable marker, as the expandable displacement member 320, 420, or 520 expands, the printed fluorescent marker can stretch along with the expansion of the displacement member 320, 420, or 520, forming an elongated marker. Alternatively, or in combination, the marker may be printed in a meandering shape, which can be transformed into a more linear shape as the expandable displacement member 320, 420, or 520 expands. In other embodiments, the fluorescent marker may simply be a small local point, such that as the expandable displacement member 320, 420, or 520 expands, the local printed point moves along with the displacement member 320, 420, or 520. A localized point printed on one side of the displacement member 320, 420, or 520 may provide a fluoroscopic indicator for, for example, the alignment of the distal lead wire compartment 120 within the body cavity. Pad printing of tungsten markers or other radiopaque materials may be used when processing these types of markers.

[0220] As shown in Figures 22a-22j, the expandable displacement member 320 may include a metal film or radiopaque marker 328 to help guide the distal lead wire section 100 or 100a. The marker 328 may have a shape that allows it to expand when the expandable displacement member 320 expands and to collapse when the expandable displacement member 320 collapses. For example, the marker 328 may have a meandering pattern. The marker 328 may have a fillet above one or more of its corners to allow the meandering patterned marker 328 to expand and collapse with minimal internal stress or strain so that the marker 328 does not break or rupture as it cycles between expansion and collapse.

[0221] Figure 22a shows an exemplary marker 328 in a crushed configuration having a meandering pattern. When an axial or radial expanding force 328a is applied, the marker 328 can expand axially and / or radially, as shown in Figure 22b.

[0222] Figures 22c and 22d show the marker 328 positioned to cover the outer surface of the expandable displacement member 320. The expandable displacement member 320 is shown in a crushed configuration with the marker 328 crushed. Figures 22e and 22f show the expandable displacement member 320 in an expanded configuration with the marker 328 expanded.

[0223] In some embodiments, the marker 328 may have a meandering pattern such that, when expanded, the marker 328 forms a specific shape such as an arrow, which can help the user better orient the distal lead wire section 100 or 100a under transparent view. Figure 22g shows an exemplary arrow-shaped marker 328 in a crushed configuration, and Figure 22h shows the arrow-shaped marker 328 in an expanded configuration under an expansion force 328a. Figure 22i shows the arrow-shaped marker 328 mounted on an expandable displacement member 320, which expands the arrow-shaped marker 328. Figure 22j shows the arrow-shaped marker 328 mounted on an expandable displacement member 320, which crushes the arrow-shaped marker 328.

[0224] The expandable displacement elements 320, 420, and 520 may be configured in a further variety of ways for various uses and advantages. As shown in Figures 19a–19h, the expandable displacement element 320 may be molded to conform to the shape of the target body cavity when expanded. For example, the expandable displacement element 320 may have a shape that conforms to the shape of the right ventricular RV when expanded. The expandable displacement elements 420 and 520 may also be configured to have a shape when expanded to conform to the shape of the target body cavity.

[0225] Figures 19a and 19b show the apical biostructure, including the right ventricular RV, left ventricular LV, the interventricular septum IVS separating the right ventricular RV from the left ventricular LV, and the free wall FW of the right ventricular RV. Figure 19b shows a cross-section of the heart obtained through line 19B.

[0226] Figure 19c shows the distal lead wire compartment 100 or 100a of the sensing / stimulating device introduced into the right ventricular RV. The expandable displacement element 320 may be expanded with an expansion medium 322 and may have an oval or elliptical cross-section when expanded to match the cross-sectional shape of the cavity in the right ventricular RV. The expansion medium 322 may include, to name a few, saline solution, water, buffer, air, or gaseous CO2, or more than one of these.

[0227] Figures 19d and 19e show the device distal lead wire compartment 100 or 100a with the expandable displacement element 320 compressed. Figures 19f and 19g show the device distal lead wire compartment 100 or 100a with the expandable displacement element 320 expanded. Figure 19e shows a side view of the device distal lead wire compartment 100 or 100a, and Figure 19d shows a cross-sectional view of the distal lead wire compartment 100 or 100a obtained through line 19D-19D. Figure 19g shows a side view of the device distal lead wire compartment 100 or 100a, and Figure 19f shows a cross-sectional view of the distal lead wire compartment 100 or 100a obtained through line 19F-19F.

[0228] Figure 19f shows the distal lead wire section 100 or 100a of the sensing / stimulating device with the expandable displacement element 320 expanded. To achieve a desired shape when expanded, the expandable displacement element 320 may comprise a wall region 320a of greater thickness and a wall region 320b of less thickness. The wall regions 320a of greater thickness may be 180 degrees opposite each other. The wall regions 320b of less thickness may be 180 degrees opposite each other. The wall regions 320a of less thickness may have a tendency to expand under lower pressure than the wall regions 320a of greater thickness. Thus, the expandable displacement element 320 may expand to have an oval or elliptical cross-section when expanded or inflated. When expanded or inflated, an expandable displacement element 320 having such a shape can provide backing force to a stabilizer (e.g., a stabilizer or deploying member 141 / 141a, 142 / 142a, 141b, 142b, 141d, 142d) and can also self-align the distal lead wire compartment 100 or 100a into the right ventricular pocket. The expandable displacement element 320 may be manufactured from an extrusion to have a wall region 320a of greater thickness and a wall region 320b of less thickness.

[0229] As discussed above and herein, the expandable displacement member 320 may be an expandable element that can be expanded with an expansion medium. Alternatively, or in combination, the distal lead wire section 100 or 100a may comprise a mechanical expander 320a which may include a mallet, expandable cage, or expandable scaffold biased into an expandable configuration. For example, the mechanical expander 320a may comprise a slotted tube made of a shape memory material such as Nitinol, and the mechanical expander 320a may have an inner lumen through which a shaft can be advanced to push the distal section 100 out of the lead wire body 120 and contract the mechanical expander 320a. Figure 23a shows, for example, a force 2301 applied to position the mechanical expander 320a in a crush configuration. Figure 23b shows a mechanical expander 320a in an expanded configuration in which anchor 2303 is expanded radially outward to deploy anchor 2305 through anchor port 2307 and radially expand electrode 2309. The mechanical expander 320a may comprise a plurality of conductive tubes 2313, each having an electrically insulating surface portion 2311 and a surface portion that is not electrically insulating and contains electrode 2309. Figure 23c shows a cross-sectional view of distal lead wire section 100 or 100a with the mechanical expander 320a, obtained from line 23C-23C in Figure 23b. As shown in Figure 23c, the tubes 2313 may extend through the lead wire body 120 and may have an inner lumen through which anchor wire 2305 can pass.

[0230] Organizational mounting components

[0231] As shown in Figures 6a, 6a', and 6b, each tissue attachment member 141, 142 may comprise a metallic, elastic, superelastic, or shape-memory wire or tube, the distal end of each wire or tube having a forming loop that can be straightened and then reshaped. The diameter of each wire or tube may range from 0.005 inches to 0.015 inches, but is not limited thereto. As shown in Figures 6a and 6b, the tissue attachment members 141, 142 may be attached side by side in a region labeled 145 by laser welding, resistance welding, crimping (using crimping tubes), or adhesive. In this region 145, the tissue attachment members may be inserted into an elongated elliptical lumen 222 so as not to rotate within the lumen, and thus this "insert" (providing an interlocking fit between the drive and follow members) allows for the forward and backward translation of the tissue attachment member assembly 140. A via or port 240 may be cut through the outer wall of the lead wire body into the lumen 222 through which the tips and distal compartments of the tissue attachment members 141, 142 are deployed. As depicted in Figures 7a and 7b, it can be understood that when the tissue attachment assembly 140 is retracted proximally, the distal loop of each wire can form a linear configuration when fully retracted into the oval lumen 222. In this configuration, once the tissue attachment members are retracted into the lead wire body, the lead wire can be advanced through the appropriate vascular system or body cavity to the target destination.

[0232] As shown in Figure 6a', the orientation of each tissue attachment member 141', 142' may be reversed so that when the tissue attachment assembly 140' is proximal retracted, each tissue attachment member 141', 142' is deployed through the deployment port 240, and when the assembly 140' is distally advanced, it is retracted into the oval lumen 222 to form a linear configuration. This configuration may be inserted into the oval lumen 222 in exactly the same manner as the tissue attachment assembly 140.

[0233] Figure 4a shows the vertical orientation of the oval lumen 402, in which the tissue attachment members 141' and 142' are oriented internally. In this configuration, it can be understood that the tissue attachment members 141' and 142' can be attached to each other in a vertical orientation rather than a horizontal orientation.

[0234] Sensing / stimulating electrode

[0235] As shown in Figures 1 and 7, electrodes 131 and 132 may be substantially mounted on the surface of the lead wire body 120, or they may be embedded within the lead wire body 120 so that a suitable surface area of ​​electrodes 131 and 132 is exposed. The associated electrode conductor 520 may be joined to electrodes 131 and 132 via laser welding, resistance welding, or conductive adhesive. The conductor 520 may pass from electrodes 131 and 132 through vias or ports 230 cut into the lead wire body 120 into the electrode conductor lumen 221. The electrode conductor 520 may then extend proximal to the lead wire handle 800 along the length of the electrode conductor lumen 221. Alternatively, or in combination, the lumen 221 may hold multiple electrode conductors 520. In this case, each electrode conductor 520 would require separate electrical insulation.

[0236] The electrodes may be substantially cylindrical so as to fit around the outer surface of the lead wire body 120. The shape of the electrodes may be varied to provide geometric shapes such as triangles, T-shapes, or trapezoids, but these embodiments do not limit the shapes that can be produced. The shape of the electrodes can serve as a visual indicator when aligning the distal portion of the lead wire body 100 with the target tissue. Figure 7b' shows embodiments of electrodes 131', 132' configured to appear trapezoidal when viewed under fluorescence fluoroscopy. Thus, electrodes 131', 132' can be mounted on the lead wire body 120 such that when the device is torqued to the appropriate position at the target tissue site under fluorescence fluoroscopy, the electrodes appear trapezoidal, indicating that the tissue attachment member ports 240 are properly aligned with the tissue where the tissue attachment members 141, 142 will be deployed.

[0237] The electrodes may also be fabricated in non-cylindrical forms such as pads, discs, patches, linear members, or microarrays of point electrodes, all of which may be substantially located on the surface of the lead wire body. These geometric shapes may provide a more concentrated interface to the target tissue, a more precise ability to sense electrophysiological signals at lower thresholds, and a higher current density when stimulating tissue by delivering an equal amount of stimulating current through a smaller surface area than that of a ring electrode.

[0238] atraumatic tip

[0239] Referring to Figures 8a-8d, the distal section 100 of the lead wire may also incorporate a distal non-traumatic tip end 600. The distal end of the main central lumen 220 may receive proximal mounting inserts 602, 603 of the distal non-traumatic tip 600. Feature 602 may be precisely sized and configured to fit into the end of the main central lumen 220, and feature 603 may be precisely sized and configured to fit into the lumen of the D-shaped element 310. Thus, the non-traumatic tip may be joined to the central main lumen 220 and the D-shaped element 310 using an adhesive or by thermal bonding, i.e., by melting these contact areas. The distal tip end may also be configured as a small inflatable balloon 610. In this embodiment, the tip end is hollow with a thinner-walled spherical tip section 616, such that the balloon expands eccentrically when the distal tip is inflated. This eccentric dilation allows the tip to be placed against the endocardial tissue in a highly non-traumatic manner, but when inflated, it cannot act to displace the lead wire body, electrode, and attachment member exit port away from the target tissue. The balloon tip 610 may be inflated through the main lumen 220 of the lead wire, or through a separate dedicated lumen of the lead wire body 120.

[0240] As shown in Figures 18a-18i, the distal section 100a of the lead wire may include one or more tip electrodes. As shown in Figure 18a, the distal section 100a of the lead wire may have a tip incorporating an integral “ball” or “spot” type electrode 1800a located at the very distal end of the lead wire tip 110, or it may be located at any radial location along the length of the tip 110. A very small diameter flexible wire may be attached to the ball or disk electrode 1800a by laser welding, crimping, conductive adhesive, or other electrical mounting methods known in the art. The electrode 1800a may perform the same stimulating function as the distal tip electrodes 131, 132, but the tip 110 of the distal lead section 100a may remain flexible and non-traumatic because the “ball” or “spot” type electrode 1800a is located on the low-durometer polymer non-traumatic tip 110 of the distal lead section 100a and can be connected to a flexible wire. Another advantage of the “ball” or spot electrode 1800a as an integral part of the tip 110 is that it may provide a fluoroscopic marker to indicate the distal tip 110 position during implantation of the device 100a. Alternatively, the “ball” 1800a may function only for fluoroscopic imaging, and not as an active electrode (without a wire attached).

[0241] Other shapes of the non-traumatic tip 110 are also considered. Figure 18b shows a cobra-head non-traumatic tip 1800b, which may be foldable to allow insertion into the sheath. Figure 18c shows a curved tip 1800c, which may be foldable to allow insertion into the sheath. Figure 18d shows a bilateral eccentric tip 1800d. Figure 18e shows a quadruple eccentric tip 1800e.

[0242] In some embodiments, the distal lead section 100a may have a tip 110 comprising a backward-facing inclined tine 1800f. The inner portion of each tine 1800f may be equipped with an electrode 1810f. The tines 1800f may engage with columnar tissue or other anatomical structures in the apical region of the right ventricle RV to provide “passive fixation” of the lead interface to biostructure. Passive fixation may generally involve any feature of the device 100a that adheres to the tissue without any feature of the device 100a that actually penetrates the tissue to provide fixation. Passive engagement may generally be achieved by the inner portion of the tine 1800f that “hooks” around anatomical features such as columnar bands found in the apical region of the ventricle. Thus, the electrode placement on the inner surface of each tine 1800f can directly interface with the anatomical feature with which the tine 1800f engages.

[0243] Electrodes may also be positioned at the distal end of each tine 1800f and / or at the distal end of the lead wire body 120 itself. Thus, bipolar sensing and pacing can be achieved from multiple electrode pairs. Other features of the lead wire may be similar to those described above and herein, e.g., band electrodes, tissue stabilizers, and eccentric balloons. Any of these features may be used, or none may be used in combination with the tine 1800f.

[0244] The "satellite" type electrode 1800g may also be positioned at various radial or circumferential locations around the lead wire tip 100a or lead wire body 120, as shown in Figures 18g and 18h. A single or double "helix" type electrode configuration 1800h may also be employed, as shown in Figure 18i. The double helix configuration may allow a bipolar electrode to be established between two helices, although one or both helical electrodes may also be used in conjunction with a ring electrode to establish various bipolar configurations. One of the helices in the double helix may comprise the positive electrode, and the other helix may comprise the negative electrode.

[0245] Laser-cut hypotubes can also be micro-machined to provide a variety of electrode shapes and numbers. An example is shown in Figure 18i, where a longitudinal electrode 1800i is machined from a laser-cut machining process.

[0246] Handle assembly

[0247] A handle assembly 800 is shown in Figure 10. The main components may include an outer handle body 810, an inner sliding actuator 808, and a handle faceplate 804. The proximal end of the lead wire body 122 may be attached to the handle faceplate using conventional bonding methods such as epoxy or UV-curable adhesive. The handle faceplate 804 may, in turn, be attached to the outer handle body 810 using similar bonding techniques. Thus, by pivoting the handle assembly 800 around its axis, rotational movement and torque can be transmitted to the lead wire body 120 via the torque control members 710, 720, or 730. Alternatively, or in combination, the lead wire body 120 may be rotated using a control member on the handle assembly 800, while the handle assembly remains stationary relative to the lead wire body 120. The inner sliding actuator 808 may be located within the outer handle body 810. The proximal end of the tissue attachment assembly 140 may emerge from the proximal end of the lead wire body 122 and may be attached to the inner sliding actuator 808 using conventional bonding methods such as epoxy or UV-curable adhesive. A finger or thumb-operated knob 806, or other operating mechanisms such as a switch, button, slider, or equivalent, may be mounted inside the inner sliding actuator 808. The knob 806 may pass through a C-shaped channel 812 within the outer handle body 810. When moved to its furthest proximal position within the channel, the tissue attachment members 141, 142 may be fully retracted into the lead wire body, as shown in Figure 7a. The knob 806 may then be moved laterally, for example, within the C-shaped channel 812 to lock the position of the inner sliding actuator 808. To advance / deploy the tissue attachment member, the knob 806 may be moved laterally to the longitudinal portion of the C-shaped channel and then advanced forward. This operation may also involve unfolding the tissue mounting members 141 and 142. The knob 806 may then be moved laterally within the C-shaped channel 812 to lock the position of the inner sliding actuator 808 in the unfolded configuration.The “C-shaped” channel 812 is just one template for guiding the movement of the knob 806 for deploying, locking, and retracting the tissue stabilizer. Other such templates may be considered. One such channel may comprise a “Z-shaped” channel in which the upper and lower horizontal sections of the Z-shape are oriented perpendicular to the axis of the handle body, and the ends of the upper and lower horizontal sections of the Z-shape can be used as locking positions for the knob 806. The knob 806 may be translated along the diagonal portions of the Z-shaped channel (connecting the upper and lower horizontal sections) to deploy and retract the tissue stabilizer.

[0248] In the proximal section of the lead wire body 122, a Y-adapter 801 may be mounted on the lead wire body. The Y-adapter may be attached to and sealed with the lead wire body 122 at both its proximal and distal ends. Small cutouts into the lead wire body and the main lumen 220 allow for communication of air or fluid from the Y-adapter port 802. This port may be configured as a standard Luer connector, which is generally known in the industry. A similar Y-adapter may be used as a directional conduit for an electrode wire to exit in the proximal region of the lead wire and terminate with a plug used to connect the lead wire to an external pacemaker.

[0249] Referring here to Figures 10A-10B, the handle faceplate 804 can rotate freely around the distal end of the handle. The handle faceplate 804 may have a circumferentially raised ring 820 that locks into place using a meshing circumferential groove or retaining ring 822 in the distal inner diameter of the handle body 810. For assembly, the handle faceplate 804 may simply be pushed onto the handle body, thus "snap" the two parts together. Sufficient clearance may be allocated in the meshing of the raised ring 820 and the circumferential groove or retaining ring 822 so that the handle faceplate can rotate freely around the handle body.

[0250] The rotation of the handle faceplate 804 may also cause the lead wire body 120 to rotate due to the connection between the faceplate 804 and the lead wire body 120. When the handle faceplate 804 and the lead wire body are rotated, the proximal end of the tissue attachment assembly 140 also rotates freely within the internal handle shuttle 808, but it may be desirable to maintain the ability to move the tissue attachment assembly 140 distally and proximal to deploy and retract the tissue attachment members. This can prevent the proximal wire of the tissue attachment assembly 140 from winding up.

[0251] Referring to Figures 10C and 10D, one way to provide this functionality is to capture the proximal end of the tissue attachment assembly 140 (wire) within a hypotube sleeve 810 attached to the internal handle shuttle 808. The proximal end of the wire of the tissue attachment assembly 140 may have a circumferential ridge feature 150 that can rotate freely within the hypotube sleeve 810, and the end of the hypotube sleeve 810 may be crimped such that the circumferential feature of the wire 150 abuts against the end crimp of the hypotube sleeve during distal / proximal translation of the hypotube sleeve 810 and the handle shuttle, thereby moving the wire 140 distal / proximal, while the proximal end of the tissue attachment assembly 140 (wire) can rotate freely within the hypotube sleeve 810.

[0252] Orientation of the lead wire itself towards the target tissue.

[0253] In general, it is understood that the procedural alignment of the distal portion of the lead wire body toward the target tissue can be greatly facilitated by the use of the torque control member shown in Figures 9a-9c. Other methods may also be employed, such as using a pre-formed two-dimensional or three-dimensional internal stylet positioned within the lead wire body, or shaping the lead wire body itself. The stylet may be permanently mounted within the lead wire body, or it may be configured to be advanced distally and retracted proximally as needed during lead delivery and implantation. The stylet may also be configured to be completely removable from the lead wire body once its use is completed in the implant procedure. In either case, the pre-shape of the stylet or the pre-shape of the lead wire body itself may be formed to follow the anatomical pathway to the target tissue and to naturally align. As an example, for the delivery of a lead wire to the right ventricle of the heart via an access through the internal jugular vein, a specific shape conforming to an entry that enters the internal jugular vein, passes through the brachiocephalic vein, the superior vena cava, the right atrium, and enters the right ventricle can be set on either the stylet or the lead wire body. This basic two-dimensional or three-dimensional path may be formed within the lead wire so as to encourage the lead wire to “self-align” with this path when the distal lead wire is delivered to the right ventricle. Furthermore, the displacement member 320 may be oriented so that when the lead wire is “self-aligned,” the displacement member 320 is substantially correctly oriented within the right ventricle and also to position the tissue attachment members 141, 142 toward the target implantation site. These alignment techniques and embodiments may be used in conjunction with a directional radiopaque marker band. The marker band may also be used as a rotation indicator as described above, with a trapezoidal shape on the electrode. The trapezoid is an eccentric shape embodiment that can face a unique direction when viewed under fluoroscopy. Incorporating an eccentric shape into the electrode is an example of a method for realizing an eccentric rotating marker, although the marker may be a separate whole or partial band formed with eccentric characteristics.

[0254] The distal lead wire section 100 may also be configured to be rotatable around the extension lead wire body 120. In this configuration, the proximal end of the distal lead wire section 100 may be rotatably attached to the distal end of the extension body 120, and the proximal end of the extension body is connected to a rotatable surface or dial on the handle via an extendable rotatable member located within the extension body 120. Thus, rotational movement is connected to the distal lead wire section 100 by rotating the dial or faceplate on the handle, while the extension lead wire body remains stationary and does not rotate.

[0255] Embodiment of a tissue stabilizer

[0256] As discussed above and herein, the tissue stabilizers or mounting members 141 and 142 may be separated longitudinally and located within the same deployment "plane". Alternatively, or in combination, multiple tissue stabilizers or mounting members 141a and 142a may be deployed from a common deployment port 230a of the distal lead section 100a of the lead body 120. The tissue stabilizer or mounting member loops 141a and 142a may be separated by an angle from 0° to more than 180°. Figures 11a-11d show tissue stabilizer or mounting member loops 141a and 142a separated by only 20° to 90°, but such ranges are not limited. Figures 11a-11c show tissue stabilizer or mounting member loops 141a and 142a extending from a common deployment port 230a. In Figure 11a, the tissue stabilizer or mounting member loops 141a and 142a are separated by only 90°. In Figure 11b, the tissue stabilizer or mounting member loops 141a and 142b are separated by more than 90°. In Figure 11c, the tissue stabilizer or mounting member loops 141a and 142b are separated by less than 90°. Figure 11d shows only the tissue mounting assembly 140a, which includes the tissue stabilizer or mounting member loops 141a and 142b. In some embodiments, each stabilizer 141a or 142a forms a loop of a certain radius. Alternatively, or in combination, the tissue mounting members 141 and 142 may face the surface of the distal lead wire body 100 or 100a, as shown in Figures 11e and 11f. The tissue mounting members 141 and 142 may initially face outward from the surface of the distal lead wire body 100 or 100a before curving backward toward the surface of the distal lead wire body 100 or 100a. In Figures 11e and 11f, the tissue stabilizer or mounting member loops 141a and 142b are separated by more than 180°, such as approximately 270°.

[0257] Mounting members or tissue stabilizers 141 and 142 may also be coplanar and exit through a common deployment port 230a as shown in Figure 12a. The axial or longitudinal separation between mounting members or tissue stabilizers 141 and 142 may vary from 0.050 inches to 0.100 inches, but is not limited thereto. A separation point may be reached where the stabilizers no longer overlap and are actually “separated” from each other. In such a case, a common deployment port 230a (as in Figure 12a) or a separate deployment port 230 may be utilized.

[0258] As discussed above and herein, two tissue stabilizers or mounting members 141 / 141a and 142 / 142a are deployed. However, the number of tissue stabilizers or mounting members may be increased to three, four, or other numbers, or reduced to one tissue mounting member. The location of the additional tissue stabilizers may also vary radially and longitudinally along the lead wire body.

[0259] As discussed above and herein, and as shown in Figure 12b, for example, the tissue stabilizers or mounting members (wire loops) 141 / 141a and 142 / 142a may have loop-shaped ends with a certain radius when in an unfolded configuration. This radius may, in practice, range from 1 mm to 5 mm, but is not limited thereto.

[0260] As shown in Figure 12c, for example, the radii of the deployed tissue stabilizers 141 / 141a and 142 / 142a may decrease along the length of the wire loop end from the proximal section of the loop to the distal section of the loop. Alternatively, or in combination, the radii of the deployed tissue stabilizers 141 / 141a and 142 / 142a may increase along the length of the wire loop end from the proximal section of the loop to the distal section of the loop.

[0261] As shown in Figures 13a and 13b, the length of the deployment port 230a for the mounting member or tissue stabilizers 141a and 142a may be extended to allow the lead wire body 120 to move in parallel across the linear portion of the tissue stabilizer wire 140a (within the lead wire body 120). This permission for movement of the lead wire body 120 across the stabilizer wire 140a allows the lead wire 100a to move freely in response to intracardiac contraction, while the tissue stabilizer loops 141a and 142a remain firmly embedded in the myocardium. Figures 13a and 13b show the positions of the stabilizers 141a and 142a when they are moved in parallel to the distal end of the deployment port 230a (Figure 13a) and the proximal end of the deployment port 230b (Figure 13b).

[0262] As shown in Figure 14, the mounting member or tissue stabilizer 141a, 142a may have a distal section of the end wire loop that is slightly linear, so that during the initial deployment of the end wire loop, the linear distal section can extend further radially away from the lead wire body 120 and "reach" before the “loop” section of the wire emerges from the lead wire deployment port 230a. This can allow the tissue stabilizers 141a, 142a to acquire as much tissue as possible to provide secure attachment to the myocardium. As shown, the linear section is at the distal tip of the mounting member or tissue stabilizer 141a, 142a, but the linear section can be located anywhere along the mounting member or tissue stabilizer.

[0263] As shown in Figures 15a-15c, the tissue stabilizer members 141b, 142b may have a tubular structure and may be, for example, a hypotube or a subcutaneous injection needle. As shown in Figure 15a, the tissue stabilizer members or needles 141b, 142b may be deployed from a common deployment port 230a, as in the forms described above and herein. It can also be understood that the stabilizer needle may be deployed from a separate port 240 in Figure 7b. Within the tissue stabilizer members or needles 141b, 142b, there may be one or more movable anchor wires 141c, 142c, respectively, and the distal ends of the wires 141c, 142c may be preformed, in embodiments, into a small helix, spiral, or pigtail. The material selected for the anchor wires 141c and 142c may be a shape memory material such that, when penetrating tissue, the distal ends of the anchor wires 141c and 142c are moved in parallel within the needles 141b and 142b, respectively, as the distal ends of the anchor wires 141c and 142c are advanced beyond the ends of the needles 141b and 142b, as shown in Figure 15b, and then the pre-formed helix is ​​straightened when the helix is ​​reformed. The needles 141b and 142b may penetrate the target tissue, thereby allowing the distal ends of the movable anchor wires 141c and 142c to advance into the target tissue to reform the helix. The needles 141b and 142b may then be retracted into the lead wire body 120, as shown in Figure 15c, leaving the anchor wires and the reformed helix embedded in the target tissue. Anchor wires 141c and 142c may be constructed from Nitinol wire, other shape memory alloys, or other shape memory monofilaments, braids, or stranded materials with a diameter of 0.002 to 0.008 inches, but the wire or monofilament is not limited to such diameters.

[0264] As shown in Figure 15c, the needle stabilizers 141b and 142b may be retracted within the lead wire body 120. Here, the anchor wires 141c and 142c may also be slightly retracted into the lead wire body to remove any "slack" in the linear sections of the anchor wires 141c and 142c, and to pull the lead wire body 120 and electrodes 131 and 132 against the tissue site into which the distal ends of the anchor wires 141c and 142c are embedded.

[0265] As shown in Figures 16a and 16b, the distal lead compartment 100a (located within the right ventricular RV) may have one or more large-diameter curved biasing loops 141d, 142d for deploying and securing the attachment of the distal lead compartment 120 to cardiac structures (such as the interventricular septum IVS separating the right ventricular RV from the left ventricular LV). These biasing loops 141d, 142d may be deployable and retractable, as well as tissue stabilizers described above and herein. When the biasing loops 141d, 142d are deployed, they may have a sufficient "reach" to engage with the tissue opposite the lead body 120, as shown in Figure 16a. In some embodiments, no balloon inflation is required to wedge the lead body 120 against the interventricular septum (i.e., deployment of the biasing loops 141d, 142d may be sufficient to push and position the lead body 120 as desired). Therefore, when the distal ends of the biasing loops 141d and 142d engage with the tissue on the opposite side of the lead wire body 120 (free wall tissue in Figures 16a and 16b), the lead wire body 120 can be moved in the opposite direction and relative to the interventricular septum IVS, that is, the lead wire 120 and the deployed biasing loops 141d and 142d may, in some embodiments, be wedge-bonded between the ventricular free wall and the interventricular septum IVS. In some embodiments, the biasing loops 141d and 142d may be equipped with electrodes so that the biasing loops 141d and 142d can function as pacing leads.

[0266] Furthermore, each biasing loop 141d, 142d also has a pointed distal end that penetrates the tissue and / or may include a movable anchor wire 141c, 142c as described above and herein. Figure 16b shows the movable anchor wires 141c, 142c deployed from the distal ends of the biasing loops 141d, 142d. The distal lead section 120 in Figure 16b is shown without the heart to provide a better image of the biasing loops 141d, 142d and the anchor wires 141c, 142c.

[0267] In Figure 16c, anchor wires 141c and 142c are shown emerging from ports located on the sides of the biasing loops 141d and 142d; however, anchor wires 141c and 142c may alternatively emerge from the distal ends of the biasing loops 141d and 142d. The distal ends of the biasing loops 141d and 142d may penetrate tissue, or the distal compartments of the biasing loops 141d and 142d may simply rest against the tissue. In either case, the distal lead wire compartment 100a may be separated from the biasing loops 141d and 142d and biased against the target tissue (tissue paced by electrodes 131 and 132). Figure 16c shows single anchor wires 141c and 142c extending from biasing loops 141d and 142d, respectively, but in some embodiments, multiple anchor wires may extend from a single biasing loop 141d or 142d.

[0268] With regard to the deployment of ballasts 141 / 141a, 142 / 142a, ballast needles 141b, 142b, or biasing loops 141d, 142d ("deployable members"), proper radial deployment of these members 141 / 141a, 142 / 142a, 141b, 142b, 141d, 142d may require precise control. If these members 141 / 141a, 142 / 142a, 141b, 142b, 141d, and 142d are simply allowed to rest within the deployment lumen 222 of the lead wire body 120, then when torque is applied to the device, the lead wire body 120 and the deployable members 141 / 141a, 142 / 142a, 141b, 142b, 141d, and 142d may undergo different amounts of twisting, and therefore the deployable members 141 / 141a, 142 / 142a, 141b, 142b, 141d, and 142d may lose their deployment alignment with the deployment ports 230, 230a of the lead wire body 120. Therefore, the "insertion" of the deployable members 141 / 141a, 142 / 142a, 141b, 142b, 141d, and 142d within the deployment lumen may be important to maintain deployment alignment of the deployable members to the deployment port.

[0269] Techniques for such "insertion" are shown, for example, in Figures 17a and 17b. The straight sections of each ballast wire 141a, 142a may be flattened, and when meshed, they form a square cross-section ("key") that can be moved in parallel within the stainless steel hypo tube 1610, whose inner diameter may be precisely formed into a square cross-section. Thus, when the ballasts 141a, 142b are moved back and forth (unfolded and retracted), the ballast wires 141a, 142b may remain aligned within the stainless steel hypo tube 1610, which has been formed with a meshing square cross-sectional outer shape. The "key" may have a square cross-section, but other shapes such as rectangles, triangles, trapezoids, and pentagons may also be used, to give a few examples.

[0270] Furthermore, the "key" should not move or rotate within the development lumen 222a of the lead wire body 120. Therefore, the key must be fixed (bonded, joined) within the development lumen of the lead wire body 120. Thus, another component, namely a "guide tube" 1600, may be provided for fixing the "key". The key guide tube assembly 140a' may be inserted into the development lumen 222 of the lead wire body 120 and attached in place using an adhesive. The "guide tube" 1600 may serve several purposes: (1) it can firmly hold the "key" in place within the development lumen 222a; and (2) it can also function as a secure containing "garage" when the tips of the ballasts 141a, 142a are fully retracted within the lead wire body 120. Regarding the latter function, if the ballast tip can be retracted into the development lumen 222a of the lead wire body 120 (the lead wire body 120 may be a low-durometer polymer), the tip can bite into the polymer and thus stop their deployment. However, the “guide tube” 1600 may be fabricated from a material with a hard surface finish (for example, Nitinol, high-durometer Hytrel polymer, Nylon) so that the ballast tip can slide along the inner surface of the guide tube 1600, allowing the ballast tip to retract and deploy freely. As shown in Figure 17b, the guide tube 1600 can be mounted in the development lumen 222a of the lead wire body 120. In many embodiments, a fluid sealing seal 1630, such as an O-ring, may be provided between the inner surface of the guide tube 1600 and the tissue attachment mechanism to prevent fluid leakage proximal through the guide tube 1600.

[0271] In some embodiments, the "key" does not need to be mounted within the "guide tube" 1600 in order to form an assembly 140a' that is mounted within the lead wire development lumen 222a. The "key" may be mounted separately from the "guide tube" 1600, either proximal or distal to the "guide tube" 1600. If the "key" is mounted distal to the "guide tube" 1600, it should be noted that the ballasts 141a, 142a may also be flattened along the loop so that when the ballasts 141a, 142a are retracted, their interlocking cross-sectional shape (square) is retracted into the square cross-sectional shape of the inner diameter of the guide tube.

[0272] In other embodiments, the guide tube 1600 may be designed and extruded from a high-durometer polymer such as Hytrel or nylon with a square inner lumen. Thus, a separate "key" may not be necessary.

[0273] Lead wires and external generator connections

[0274] Referring here to Figures 24a-24c, in some embodiments, the electrical sensing / stimulation device or temporary pacing lead wire 10 may include a lead wire connector plug 2403 connected to the proximal portion of the distal lead wire body 100 or 100a to supply power to electrodes 131 and 132. The connector plug 2503 may be connected to or plugged into an external generator 2501. The connector plug 2503 may be tightly mated into the external generator 2401.

[0275] It may be desirable, at least in some cases, that the connector plug 2403 be easily disconnected from the external generator 2401, particularly when pulled or strongly pulled relative to the external generator 2401. For example, the connection between the connector plug 2403 and the external generator 2401 may be at least partially magnetic. The strength of the magnetic connection may be adjusted, for example, by selecting a magnet of appropriate size so that the connector plug 2403 can be disconnected from the external generator 2401 under a given force or displacement. To provide a magnetic connection, a magnetic connection hub 2405 may be provided as shown in Figures 24b and 24c. Figure 24b shows the external generator 2401, connector plug 2403, and magnetic connection hub 2405 disconnected, and Figure 24c shows these elements when connected together. The proximal end of the connector plug 2403 may include a magnet 2407 with a first polarity that complements the magnet 2409 with a second opposite polarity of the magnetic connection hub 2405. The magnetic connection hub 2405 may include conductors 2411 that can electrically connect the electrode wires of the connector plug 2403 to the electrical outlet of the external generator 2401. The magnetic connection hub 2405 may form a tightly mated connection with the external generator 2401.

[0276] In at least some cases, the distal lead section 100 or 100a may tend to move away from the apex when the patient moves away from the external generator 2401, while the introducer sheath used to introduce the electrical sensing / stimulation device remains stationary relative to the patient. This movement of the distal lead section 100 or 100a may be reduced or eliminated if desired. In some embodiments, a retractable extension cord may be provided. A retractable extension cord 2501 may be provided between the temporary pacing lead lines 10, as shown in Figures 25a–25f. Alternatively, a retractable extension cord 2651 may be incorporated into the temporary pacing lead line 10 itself, as shown in Figure 26g.

[0277] As shown in Figures 25a-25f, the retractable extension cord adapter 2501 may be an interface between the temporary pacing lead wire 10 and the external generator 2401. The retractable extension cord adapter 2501 may comprise a torsion device 2503, a proximal cord 2505, a distal cord 2507, and a connector 2509 for connecting to the external generator 2401. At least portions of the cords 2505 and 2507 may be wound around the torsion device 2503, as shown in Figures 25d, 25e, and 25f. The torsion device 2503 may provide bias for the retractable extension cord adapter 2501 to be in an axially retracted configuration, as shown in Figures 25a and 25b. In the axial retraction configuration shown in Figure 25b, the distance between the external generator 2401 and the torsion device 2503 may be a first length 2505a straddled by the proximal cord 2505, and the distance between the torsion device 2503 and the end of the distal cord 2507 may be a second length 2507a straddled by the distal cord 2507. An axial force 2511 may be applied to pull the retractable extension cord adapter 2501 into an axial extension or extension configuration. The magnitude (or strength) of the axial force 2511 can be adjusted, for example, by selecting a torsion spring of appropriate size with a desired torsion spring constant. In the axial extension or expansion configuration shown in Figure 25c, the distance between the external generator 2401 and the torsion device 2503 may be greater than a first length 2505a and be a third length 2505b straddled by the proximal cord 2505, and the distance between the torsion device 2503 and the end of the distal cord 2507 may be greater than a second length 2507a and be a fourth length 2507b straddled by the distal cord 2507. Figure 25f shows an exploded view of the torsion device 2503, which may include an upper fixture 2513, a bottom fixture 2515, a torsion spring 2517, a geared tooth 2623, a latch 2519, and a torsion spring 2521 between the latch 2519 and the bottom fixture 2515. When an axial force 2511 is applied, the torsional device 2503 may be disassembled, and when the force is removed, the latch 2519 may prevent the cords 2505 and 2507 from retracting.The latch 2519 may be opened so that the codes 2505 and 2507 can be wound back onto the torsion device 2503. In combination with the torsion device 2503, magnetic connections or couplings as described above may also be used.

[0278] Tissue stabilizer movement detection

[0279] In at least some cases, it may be desirable to detect or measure the movement of the tissue attachment member 141 or 142 (or any of the attachment members described above and herein) when engaging with tissue.

[0280] An array for detecting or measuring the movement of tissue mounting members 141, 142 is shown in Figure 26a. Mounting members 141, 142 may be connected to a magnet 2601 in the distal lead wire compartment 100 or 100a. The magnet 2601 may move in parallel within the inner lumen of the distal lead wire compartment 100 or 100a as the mounting members 141, 142 are moved. Such movement may be relative to and inside the conductive tube 2603 in the distal lead wire compartment 100 or 100a and may generate a measurable current through a wire 2605 connected to the conductive tube 2603. The current may pass through a resistor connected to ground so that a voltage measurement can be obtained. The measured voltage can be amplified, and therefore the variation in the voltage reading will correlate with the displacement of the mounting members.

[0281] Another array for detecting or measuring the movement of tissue attachment members 141, 142 is shown in Figure 26b. Attachment members 141, 142 may be connected to a magnet 2601 in the distal lead section 100 or 100a. The magnet 2701 may move in parallel within the lumen of the distal lead section 100 or 100a as the attachment members 141, 142 are moved. Such movement may be relative to and inside the conductive tube 2603 in the distal lead section 100 or 100a. A first wire 2631 may be connected to the magnet 2601, a second wire 2633 may be connected to the conductive tube 2603, and the first and second wires 2631, 2633 may be connected to a Wheatstone bridge 2635. Movement of anchors 141 and 142 may increase or decrease the distance 2630, and may change the resistance from node 2635A to node 2635B in the Wheatstone bridge 2635. The output of the Wheatstone bridge 2635 may be input to amplifier 2637, and changes in the output voltage 2639 may be detected, indicating the movement of anchors 141 and 142.

[0282] Movement of anchors 141 and 142 may be detected and indicated to the user through an LCD (liquid crystal display) display 2652 of a handle 2650 connected to a distal lead wire section 100 or 100a, as shown in Figure 26c, or through an LED or LED (light-emitting diode) display 2654 of the handle 2650, as shown in Figure 26d. Figure 26e shows a schematic diagram of the circuit of the handle 2650. The handle 2650 may include a microcontroller or MCU 2656, which may be connected to one or more of the following: a Wheatstone bridge 2635, an amplifier 2637, or a current sensing circuit 2658. LED displays 2652 and / or LED displays 2654 may be connected to the microcontroller 2656.

[0283] The handle 2650 may also include other control and / or display mechanisms for the distal lead wire compartment 100 or 100a. For example, the handle 2650 may include one or more knobs, switches, buttons, sliders, or equivalents for deploying a tissue attachment member, activating an electrode, or extending an expandable displacement member, or more than one of these. The LCD display 2652 or LED display 2654 may also indicate capacitance changes, resistance changes, pressure changes, or equivalents that may occur when the distal lead wire compartment 100, 100a is used in interaction with tissue.

[0284] Lead wire torque control and lead wire molding

[0285] Referring here to Figures 27a and 27b, many embodiments may include features for torque control and / or shaping of the distal lead wire section 100 or 100a. The lead wire body 120 may have an internal lumen through which an internal shaping wire 2710 can be translated. The internal shaping wire 2710 may allow the user to bend and shape the distal lead wire section 100 or 100a, facilitating its passage through the vascular system. The internal shaping wire 2710 may be biased to have a curved end so as to impart the same curved shape to the distal lead wire section 100 or 100a, as shown in Figure 27a. As the distal lead wire section 100 or 100a is advanced through the vascular system, the curve positioned on the distal lead wire section 100 or 100a can be made to naturally "align" the distal lead wire section 100 or 100a with the vascular pathway. In one example, when the distal lead compartment 100 or 100a is navigated from the femoral vein into the right ventricle, a pre-shaping curve (a large U-shape as shown in Figure 27a) may be aligned with itself along the path from the inferior vena cava into the right atrium, through the tricuspid valve, into the right ventricle. The pre-shaping curve may be straightened as needed to traverse a more linear compartment of the insertion path, or it may retain its curved shape to navigate bends in the path toward the target tissue.

[0286] In some embodiments, multiple shaping wires may be used. For example, a first internal shaping wire may be used to help advance the distal lead wire compartment 100 or 100a through a first portion of the vascular system, and a second internal shaping wire with a different shape may be used to help advance the distal lead wire compartment 100 or 100a through a second portion of the vascular system.

[0287] The internally molded wire 2710 may be used alone or in conjunction with the torque control member 2720. The torque control member 2720 may comprise a tube or hypotube that is movable in parallel within the inner lumen of the lead wire body 120 or to which it is coupled. The internally molded wire 2710 may reside within the torque control member 2720 as shown in Figure 27b. Alternatively, the internally molded wire 2710 may reside within the lead wire body 120 adjacent to the torque control member 2720. The torque control member 2720 may reside within the lead wire body 120 and, in some embodiments, may be coupled to the lead wire body 120 so that the two can function as a single component. Thus, when the proximal portion of the lead wire body 120 is swirled or torque is applied, the distal lead wire section 100 or 100a can be traversed as shown by the arrows 2701a and 2701b in Figure 27a.

[0288] In some embodiments, the internally molded wire 2710 is not attached to the lead wire body 120 and / or torque member 2720 so that the torque member 2720 and the lead wire body can rotate around the curved axis of the molded wire as shown by arrows 2701a and 2701b in Figure 27a.

[0289] While preferred embodiments are shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided only as examples. Numerous modifications, changes, and substitutions will be conceivable to those skilled in the art without departing from the scope of this disclosure. It should be understood that various alternatives to the embodiments described herein may be employed in practicing the inventions of this disclosure. As non-limiting embodiments, it will be understood to those skilled in the art that certain features or characteristics described with reference to one figure or embodiment may be appropriately combined with features or characteristics described in another figure or embodiment. The following claims define the scope of the invention and are intended to encompass the methods and structures within the scope of these claims and their equivalents.

Claims

1. An electrical sensing / stimulation device, wherein the device is A guide tube having a lumen, wherein the lumen of the guide tube has a cross-sectional shape, A plurality of stabilizer wires are at least partially disposed within the lumen of the guide tube and are movable parallel to the guide tube, each stabilizer wire having a tissue contact end and a straight section, and the plurality of stabilizer wires interlock to form a tissue attachment member assembly having a combined cross-sectional shape, the tissue attachment member assembly is fitted into the lumen of the guide tube, and the cross-sectional shape prevents the tissue attachment member assembly from rotating within the lumen when one or more of the plurality of stabilizer wires are moved parallel to the guide tube, An extension body having an expanding lumen, wherein the guide tube is positioned and fixed within the expanding lumen, and A device equipped with the following features.

2. The apparatus according to claim 1, wherein one or more of the plurality of ballast wires have tissue contact ends that are equipped with a stabilizing element.

3. The apparatus according to claim 2, wherein the stabilizing element comprises a tissue-contact distal loop.

4. The apparatus according to claim 2, wherein the stabilizing element has a tissue-penetrating tip.

5. The apparatus according to claim 1, wherein the plurality of ballast wires comprises a first ballast wire having a first straight section and a second ballast wire having a second straight section, and the first ballast wire and the second ballast wire interlock to form the tissue attachment member assembly that fits into the lumen of the guide tube by having the combined cross-sectional shape.

6. The apparatus according to claim 5, wherein the cross-sectional shape of one or more of the first ballast wire or the second ballast wire is rectangular.

7. The apparatus according to claim 6, wherein the cross-sectional shape of the lumen of the guide tube is square, the cross-sectional shapes of the first ballast wire and the second ballast wire are both rectangular, and the rectangular cross-sectional shapes of the first ballast wire and the second ballast wire are adapted to interlock with each other to form a square that is precisely sized to fit within the square cross-sectional shape of the lumen of the guide tube.

8. The apparatus according to claim 1, wherein the cross-sectional shape of the lumen of the guide tube is polygonal.

9. The apparatus according to claim 8, wherein the cross-sectional shape of the lumen of the guide tube is square or rectangular.

10. The apparatus according to claim 1, wherein the guide tube is adapted to be housed within the development lumen of an implantable device.

11. The apparatus according to claim 10, wherein the guide tube is fixed within the expansion lumen of the implantable device.

12. The apparatus according to claim 10, wherein the implantable device comprises one or more deployment ports, and the guide tube is housed within the deployment tube lumen of the implantable device such that the tissue contact ends of the stabilizer wires are either able to advance from the one or more deployment ports or can be able to retract through the one or more deployment ports.

13. The apparatus according to claim 12, wherein the tissue attachment member assembly of the stabilizer wire, which is fitted into the lumen of the guide tube, is located proximal to one or more deployment ports.

14. The apparatus according to claim 1, wherein at least a portion of the guide tube has a non-circular outer circumference.

15. The apparatus according to claim 1, further comprising a fluid sealing seal between the inner surface of the guide tube and at least a portion of the ballast wire.

16. The apparatus according to claim 1, wherein at least a portion of the guide tube is made from a high-durometer polymer.

17. The apparatus according to claim 1, wherein at least a portion of the guide tube is made of one or more of stainless steel, nitinol, hytrel, and nylon.

18. The apparatus according to claim 1, wherein the guide tube comprises a tubular section and a key-shaped section at least partially mounted within the tubular section, and the key-shaped section has a cross-sectional shape.

19. The apparatus according to claim 18, wherein the tubular section and the key-shaped section are made from different materials.

20. The apparatus according to claim 19, wherein the key-shaped section is made of metal and the tubular section is made of polymer.

21. The apparatus according to claim 1, wherein the guide tube has a predetermined curvature or radius of curvature.

22. The apparatus according to claim 21, wherein the tissue mounting member assembly of the ballast wire fitted into the guide tube is positioned in the straight portion of the guide tube proximal to the predetermined curve or radius of curvature.

23. The apparatus according to claim 1, wherein the guide tube is fixed within the expansion lumen, and the cross-sectional shape of the expansion lumen prevents the guide tube from rotating relative to the extension body.

24. The apparatus according to claim 23, wherein the cross-sectional shape of the expanded lumen is polygonal.

25. The apparatus according to claim 1, wherein the extension body comprises one or more deployment ports, and the tissue contact end of the ballast wire is either advancing from the one or more deployment ports or retracting through the one or more deployment ports.

26. The apparatus according to claim 1, wherein at least a portion of the extension body is made from a polymer material.

27. ​​An electrical sensing / stimulation device, wherein the device is A guide tube having a lumen, wherein the lumen of the guide tube has a cross-sectional shape, A plurality of ballast wires are at least partially disposed within the lumen of the guide tube and are movable parallel to the guide tube. Each ballast wire has a tissue contact end and a straight section, and the plurality of ballast wires interlock to form a tissue attachment member assembly having a combined cross-sectional shape, the tissue attachment member assembly is fitted into the lumen of the guide tube, so that when one or more of the ballast wires are moved parallel to the guide tube, the cross-sectional shape of the guide tube prevents the tissue attachment member assembly from rotating within the lumen. The device comprises a tubular section and a key-shaped section at least partially mounted within the tubular section.

28. The apparatus according to claim 27, wherein one or more of the plurality of ballast wires have tissue contact ends that are equipped with stabilizing elements.

29. The apparatus according to claim 28, wherein the stabilizing element comprises a tissue-contact distal loop.

30. The apparatus according to claim 28, wherein the stabilizing element has a tissue-penetrating tip.

31. The apparatus according to claim 27, wherein the plurality of ballast wires comprises a first ballast wire having a first straight section and a second ballast wire having a second straight section, and the first ballast wire and the second ballast wire interlock to form the tissue attachment member assembly that fits into the lumen of the guide tube by having the combined cross-sectional shape.

32. The apparatus according to claim 31, wherein the cross-sectional shape of one or more of the first ballast wire or the second ballast wire is rectangular.

33. The apparatus according to claim 32, wherein the cross-sectional shape of the lumen of the guide tube is square, and the cross-sectional shapes of the first ballast wire and the second ballast wire are both rectangular, and the rectangular cross-sectional shapes of the first ballast wire and the second ballast wire are adapted to interlock with each other to form a square that is precisely sized to fit within the square cross-sectional shape of the lumen of the guide tube.

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