Delivery Devices and Related Methods

Abstract

A delivery device configured to deliver a therapeutic device and a visualization device to a surgical site is disclosed. An exemplary delivery device can include a proximally disposed handle; a shaft extending distally from the handle, the shaft including a therapeutic device lumen configured to deliver a working end of a therapeutic device therethrough, a first portion of the shaft being steerable; and a space creating element disposed proximate a distal end portion of the shaft, the space creating element configured to separate biological tissue and generate or expand a working space. At least a portion of the space creating element can be reconfigurable between a retracted configuration and an expanded configuration.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 161,902, filed March 16, 2021, the contents of which are incorporated by reference.

[0002] The present disclosure relates to medical instruments and devices for performing surgical procedures, and more particularly to delivery devices (eg, cannulas, etc.) and related methods for surgical procedures. [Background technology]

[0003] The present disclosure contemplates that some medical procedures (e.g., minimally invasive surgical procedures, etc.) may involve the use of elongated surgical instruments at a surgical site within a patient's body. In some such procedures, it may be advantageous to guide the surgical instruments to the surgical site along a path that curves around an anatomical structure, such as to minimize trauma or other effects on an intervening anatomical structure between a skin access point and the surgical site. For example, a minimally invasive procedure involving some portions of a patient's heart (e.g., the left atrial appendage) may involve a skin penetration on the anterior surface of the patient's abdomen, a penetration through the pericardium, and a path along the posterior surface of the patient's heart. Because such paths may not be straight, it may be difficult to guide various surgical instruments to the surgical site. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] US Patent Application Publication No. 2021 / 0008338 [Patent Document 2] U.S. Pat. No. 8,721,597 Summary of the Invention [Problem to be solved by the invention]

[0005] Although known devices and techniques have been used to perform minimally invasive procedures, improvements in the construction and operation of delivery devices for surgical instruments could be beneficial to users (e.g., surgeons) and patients. The present disclosure includes various improvements that can enhance the construction, operation, and methods of use of delivery devices (e.g., for minimally invasive procedures, etc.). [Means for solving the problem]

[0006] One aspect of the present disclosure is to provide a delivery device configured to deliver a therapeutic device to a surgical site, the delivery device including a proximally disposed handle; an elongate shaft extending distally from the handle, the shaft including a generally longitudinal therapeutic device lumen configured to deliver a working end of the therapeutic device therethrough; and / or a space creating element disposed proximate a distal end portion of the shaft, the space creating element configured to separate biological tissue and generate or expand a working space. A first portion of the shaft may be steerable and / or at least a portion of the space creating element may be reconfigurable between a retracted configuration and an expanded configuration.

[0007] In detailed embodiments, the shaft can include a generally longitudinal visualization device lumen configured to deliver a working end of a visualization device therethrough, the handle can include a therapeutic device lumen and a proximal port operably connected to the visualization device lumen and / or the proximal port can be configured to receive a therapeutic device and / or visualization device therethrough.

[0008] In particular embodiments, the shaft can include a generally longitudinal first suction lumen configured to facilitate application of suction proximate the distal end portion of the shaft. The shaft can include a generally longitudinal second suction lumen configured to facilitate application of suction proximate the distal end portion of the shaft.

[0009] In a detailed embodiment, in the retracted configuration, the space-creating element can have a width that is approximately the same as the width of the shaft, and in the expanded configuration, the space-creating element can have a width that is substantially greater than the width of the shaft.

[0010] In a detailed embodiment, in the collapsed configuration, at least a portion of the space-creating element can be generally concentrically disposed within the distal end portion of the shaft, and the distal end portion of the shaft can include a recess configured to receive at least a portion of the space-creating element in the collapsed configuration.

[0011] In a detailed embodiment, the space-making element may include an expandable space-making element. The shaft may include a generally longitudinal first inflation lumen operatively coupled to supply inflation fluid to the expandable space-making element. The expandable space-making element may be generally in the form of a right circular cylinder. The expandable space-making element may include a plurality of generally circumferentially oriented ribs. The expandable space-making element may include a plurality of generally longitudinally oriented ribs. The expandable space-making element may include at least one orientation feature. The orientation feature may include a notch. The expandable space-making element may include a distal surface that is angled with respect to a plane perpendicular to the longitudinal axis of the shaft. The expandable space-making element may include a plurality of longitudinally oriented expandable elements. At least one of the plurality of longitudinally oriented expandable elements may be in the form of a generally circular tube. At least one of the plurality of longitudinally oriented expandable elements may be in the form of a tube having a generally elliptical cross-section. The expandable space-creating element can include at least one foldable structural element configured to facilitate spacing apart the longitudinally oriented expandable elements. The foldable structural element can include a foldable Nitinol frame. The expandable space-creating element can include at least one generally helical expandable element. The expandable space-creating element can include two generally helical expandable elements in an alternating arrangement.

[0012] In a detailed embodiment, the first portion of the shaft may be steerable in a first plane. The handle may include a steering actuator configured to steer the first portion of the shaft in the first plane. The first portion of the shaft may be steerable unidirectionally in the first plane. The first portion of the shaft may be steerable bidirectionally in the first plane. The first portion of the shaft may be deformable in a second plane. The second plane may be generally perpendicular to the first plane. The first portion of the shaft may be flexible in the second plane. The first portion of the shaft may be steerable in the second plane. The first portion of the shaft may be steerable bidirectionally in the first plane and / or bidirectionally in the second plane. The delivery device may include a first steering wire, the first steering wire operably coupling the steering actuator and the first portion of the shaft to steer the first portion of the shaft in a first direction in the first plane. The delivery device can include a second steering wire operatively connecting the steering actuator and the first portion of the shaft for steering the first portion of the shaft in a second direction in a first plane, the second direction being generally opposite to the first direction. The second portion of the shaft can be flexible in the second plane. The second plane can be generally perpendicular to the first plane. The handle can include at least one locking actuator configured to selectively lock the steering actuator.

[0013] In a detailed embodiment, the second portion of the shaft can be flexible in a first plane. The second portion of the shaft can be flexible in a second plane. The second plane can be generally perpendicular to the first plane. The flexibility of the second portion of the shaft in the first plane can be greater than the flexibility of the second portion of the shaft in the second plane. The stiffness of the second portion of the shaft in the first plane can be greater than the stiffness of the second portion of the shaft in the second plane. The second portion of the shaft can be substantially uniformly flexible over the longitudinal length of the second portion of the shaft. The shaft flexibility can vary longitudinally over the longitudinal length of the second portion of the shaft. The flexibility of the first portion of the shaft can be different from the flexibility of the second portion of the shaft.

[0014] In a detailed embodiment, the shaft can include an outer jacket and a structural component radially disposed within the outer jacket. The structural component can include a hypotube. The hypotube can include a plurality of solid portions and / or a plurality of gaps configured to promote a desired flexibility characteristic of the shaft. The hypotube can include a first arrangement of solid portions and / or gaps in a first portion of the shaft and / or a second arrangement of solid portions and / or gaps in a second portion of the shaft, such that the first portion of the shaft and the second portion of the shaft have different flexibility characteristics.

[0015] In a detailed embodiment, the delivery device can include an obturator positioned distally on the shaft. The obturator can be expandable. The obturator can be selectively removable from the delivery device.

[0016] In particular embodiments, the therapeutic device may include at least one of an ablation device, a biopsy device, a pericardial lead, a needle for delivering a therapeutic agent, and / or a surgical tool.

[0017] In particular embodiments, the visualization device may include an endoscope.

[0018] One aspect of the present disclosure is to provide a delivery device configured to deliver a therapeutic device to a surgical site, the delivery device including a proximally disposed handle; an elongate shaft extending from the handle, the shaft including a generally longitudinal therapeutic device lumen through which a working end of a therapeutic device is configured to be delivered; and / or a space creating element disposed proximate a distal end portion of the shaft, the space creating element configured to separate biological tissue and create or expand a working space. A first portion of the shaft can be flexible.

[0019] In particular embodiments, the space-creating elements may be reconfigurable between contracted and expanded configurations by expansion and contraction of at least one expandable element.

[0020] In a detailed embodiment, the space-creating element can be substantially rigid. The space-creating element can include a deep angled hood.

[0021] In a detailed embodiment, the first portion of the shaft can be flexible in a first plane. The second portion of the shaft can be flexible in a second plane. The second plane can be generally perpendicular to the first plane. The first portion of the shaft can include a distal portion. The second portion of the shaft can include a proximal portion. The first portion of the shaft can be steerable in the first plane by operation of a steering actuator disposed on the handle. The first portion of the shaft can be flexible in the second plane.

[0022] One aspect of the present disclosure is to provide a method of using a delivery device, the method including the steps of positioning a distal end portion of an elongate shaft of the delivery device at a desired location; expanding a reconfigurable space-making element disposed distally on the shaft from a retracted configuration to an expanded configuration; generating or expanding a working space at the desired location using the space-making element; and / or directing a working end of a therapeutic device through the shaft to the desired location via a longitudinally extending therapeutic device lumen.

[0023] In detailed embodiments, positioning a distal end portion of an elongate shaft of a delivery device at a desired location can include advancing the shaft using a handle disposed proximally on the shaft. The distal end portion of the shaft can be steerable by a steering actuator disposed on the handle. Positioning a distal end portion of a delivery device shaft at a desired location can include operating the steering actuator to steer the distal end portion of the shaft. Operating the steering actuator to steer the distal end portion of the shaft can include pulling a steering wire extending longitudinally through the shaft to deflect the distal end portion.

[0024] In a detailed embodiment, the proximal portion of the shaft can be flexible in a first plane. Positioning the distal end portion of the shaft of the delivery device at a desired location can include bending the proximal portion of the shaft in the first plane. The distal end portion of the shaft can be steerable in a second plane. The second plane can be generally perpendicular to the first plane. Positioning the distal end portion of the shaft of the delivery device at a desired location can include steering the distal end portion of the shaft in the second plane. The distal end portion of the shaft can be flexible in the first plane. Positioning the distal end portion of the shaft of the delivery device at a desired location can include bending the distal end portion of the shaft in the first plane.

[0025] In a detailed embodiment, the reconfigurable space-creating element can include an inflatable space-creating element, and expanding the reconfigurable space-creating element can include delivering an inflation fluid to the inflatable space-creating element through an inflation lumen disposed longitudinally within the shaft.

[0026] In a detailed embodiment, expanding the reconfigurable space-making elements may include expanding the reconfigurable space-making elements laterally.

[0027] In a detailed embodiment, expanding the reconfigurable space-creating element may include expanding the reconfigurable space-creating element longitudinally.

[0028] In particular embodiments, positioning the distal end portion of the elongate shaft of the delivery device at a desired location can include positioning the distal end portion adjacent to a left atrial appendage of the patient's heart. Positioning the distal end portion adjacent to the left atrial appendage can include advancing the distal end portion toward the posterior of the patient's heart.

[0029] An aspect of the present disclosure is to provide any apparatus, method, or combination thereof as disclosed herein. An aspect of the present disclosure is to provide any two or more of the above-mentioned aspects and / or features in any combination. An aspect of the present disclosure is to provide any combination of elements from one or more of the above-mentioned aspects and / or features.

[0030] Exemplary embodiments are described with reference to the accompanying drawing figures. [Brief description of the drawings]

[0031] [Figure 1] FIG. 1 is a simplified schematic diagram of an exemplary delivery device, according to at least some aspects of the present disclosure. [Diagram 2] FIG. 1 is a perspective view of an exemplary delivery device according to at least some aspects of the present disclosure. [Diagram 3] FIG. 1 is a simplified cross-sectional view of an exemplary delivery device according to at least some aspects of the present disclosure. [Figure 4] FIG. 1 is a perspective view of an exemplary handle of a delivery device, according to at least some aspects of the present disclosure. [Figure 5A] FIG. 1 illustrates a distal perspective view of an exemplary space-making element generally in the form of a right circular cylinder, according to at least some aspects of the present disclosure. [Figure 5B] FIG. 13 is a distal perspective view of an exemplary space-creating element generally in the form of a deep angled hood, according to at least some aspects of the present disclosure. [Figure 5C]FIG. 13 illustrates a distal perspective view of an exemplary space-creating element in the form of a generally shallow angled hood, according to at least some aspects of the present disclosure. [Figure 5D] FIG. 13 is a distal perspective view of an exemplary space-creating element generally in the form of a deep angled hood, according to at least some aspects of the present disclosure. [Figure 5E] 1 is a distal perspective view of an exemplary space-making element, generally in the form of a shaped distal end portion of a shaft, according to at least some aspects of the present disclosure. FIG. [Figure 5F] 1A-1C are distal perspective views of an exemplary space-making element generally in the form of a flat distal end surface of a shaft, according to at least some aspects of the present disclosure. [Figure 5G] FIG. 1 illustrates a perspective view of an exemplary space-making element generally in the form of an elongated cylinder with an angled tip, according to at least some aspects of the present disclosure. [Figure 6A] 1 is a simplified cross-sectional view of a distal portion of a delivery device including an exemplary expandable space-creating element in a collapsed configuration, according to at least some aspects of the present disclosure. [Figure 6B] 6B is a simplified cross-sectional view of the expandable space-creating element of FIG. 6A in an expanded configuration, according to at least some embodiments of the present disclosure. [Figure 6C] FIG. 1 is a simplified side view of a distal portion of a delivery device including an exemplary expandable space-creating element in a contracted configuration and an expandable obturator in an expanded configuration, according to at least some aspects of the present disclosure. [Figure 6D] FIG. 6D is a simplified cross-sectional view of a distal portion of the delivery device of FIG. 6C with an expandable space-creating element in an expanded configuration, according to at least some embodiments of the present disclosure. [Figure 7A] FIG. 13 is a simplified cross-sectional view of a distal portion of an exemplary delivery device including an expandable space-creating element disposed proximally from where the scope emerges, according to at least some aspects of the present disclosure. [Figure 7B]FIG. 7B is a distal view of the delivery device of FIG. 7A, according to at least some embodiments of the present disclosure. [Figure 8] FIG. 13 is a distal perspective view of an exemplary delivery device including a selectively deployable skirt, according to at least some aspects of the present disclosure. [Figure 9] FIG. 13 is a perspective view of a distal portion of an exemplary delivery device including a movable space-creating element, according to at least some aspects of the present disclosure. [Figure 10] FIG. 13 is a simplified side view of a distal portion of an exemplary delivery device including a movable space-creating element, according to at least some aspects of the present disclosure. [Figure 11] FIG. 13 is a simplified side view of a distal portion of an exemplary delivery device including a movable space-creating element, according to at least some aspects of the present disclosure. [Figure 12A] FIG. 13 is a simplified side view of a distal portion of an exemplary delivery device including two expandable elements, according to at least some embodiments of the present disclosure. [Figure 12B] FIG. 12B is a distal view of the delivery device of FIG. 12A, according to at least some embodiments of the present disclosure. [Figure 13A] FIG. 1 is a simplified cross-sectional view of an exemplary shaft including a rotatable inner shaft portion, according to at least some aspects of the present disclosure. [Figure 13B] FIG. 13B is a perspective view of a distal end portion of the shaft of FIG. 13A, according to at least some embodiments of the present disclosure. [Figure 14] FIG. 1 is a simplified cross-sectional view of an exemplary shaft including a rotatable outer shaft portion, according to at least some aspects of the present disclosure. [Figure 15A] FIG. 1 is a simplified cross-sectional view of an exemplary shaft including an outer shaft portion having a non-circular outer circumference, according to at least some aspects of the present disclosure. [Figure 15B] FIG. 15B is a perspective view of a distal end portion of the shaft of FIG. 15A, according to at least some embodiments of the present disclosure. [Figure 16]FIG. 1 is a simplified cross-sectional view of a delivery device including a lock brake mechanism and an endoscope, in accordance with at least some aspects of the present disclosure. [Figure 17] FIG. 13 is a top view of an alternative exemplary delivery device, according to at least some aspects of the present disclosure. [Figure 18] FIG. 18 is a proximal perspective view of the delivery device of FIG. 17, according to at least some embodiments of the present disclosure. [Figure 19] FIG. 18 is a detailed distal perspective view of the delivery device of FIG. 17, according to at least some embodiments of the present disclosure. [Figure 20] 18 is a detailed distal perspective cross-sectional view of the shaft of the delivery device of FIG. 17, according to at least some embodiments of the present disclosure. [Figure 21] FIG. 18 is a proximal perspective view of structural components of the shaft of the delivery device of FIG. 17, according to at least some embodiments of the present disclosure. [Figure 22] FIG. 18 is a detailed perspective view of a distal end portion of a structural component of the shaft of the delivery device of FIG. 17, according to at least some embodiments of the present disclosure. [Figure 23] FIG. 13 is a proximal perspective view of an alternative exemplary expandable space-creating element including circumferential ribs, according to at least some aspects of the present disclosure. [Figure 24] FIG. 13 is a proximal perspective view of an alternative exemplary expandable space-creating element including longitudinal ribs, according to at least some aspects of the present disclosure. [Diagram 25] 13A-13C are distal perspective views of alternative exemplary expandable space-creating elements including orientation features, according to at least some aspects of the present disclosure. [Figure 26] 13A-13C are side views of alternative exemplary expandable space-creating elements including angled distal surfaces, in accordance with at least some aspects of the present disclosure. [Figure 27] FIG. 13 is a simplified cross-sectional side view of an alternative expandable space-creating element including multiple longitudinally oriented expandable elements, according to at least some aspects of the present disclosure. [Figure 28]FIG. 28 is a simplified distal end view of the expandable space-creating element of FIG. 27, according to at least some embodiments of the present disclosure. [Figure 29] FIG. 13 is a simplified cross-sectional side view of an alternative expandable space-creating element including a plurality of flattened longitudinally oriented expandable elements, according to at least some aspects of the present disclosure. [Diagram 30] FIG. 30 is a simplified distal end view of the expandable space-creating element of FIG. 29, according to at least some embodiments of the present disclosure. [Diagram 31] FIG. 13 is a simplified side view of an alternative expandable space-creating element including a coiled expandable element, according to at least some aspects of the present disclosure. [Diagram 32] FIG. 32 is a simplified distal end view of the expandable space-creating element of FIG. 31 , according to at least some embodiments of the present disclosure. [Diagram 33] FIG. 13 is a distal perspective view of a distal end portion of an alternative exemplary delivery device including a rigid space-creating element, according to at least some aspects of the present disclosure. [Diagram 34] FIG. 13 is a detailed perspective view of a distal end portion of an alternative exemplary structural component of a shaft of a delivery device, according to at least some aspects of the present disclosure. [Diagram 35] FIG. 13 is a top view of an alternative exemplary delivery device, according to at least some aspects of the present disclosure. [Diagram 36] FIG. 1 is a perspective view of an alternative exemplary delivery device according to at least some aspects of the present disclosure. [Figure 37] FIG. 1 is a perspective view of an alternative exemplary delivery device according to at least some aspects of the present disclosure. [Figure 38] FIG. 1 is a perspective view of an alternative exemplary delivery device according to at least some aspects of the present disclosure. [Figure 39] FIG. 1 is a perspective view of an alternative exemplary delivery device according to at least some aspects of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] Exemplary embodiments according to the present disclosure are described and illustrated below to encompass devices, methods, and techniques related to medical treatment. Of course, it will be clear to those skilled in the art that the embodiments discussed below are examples and may be reconfigured without departing from the scope and spirit of the present disclosure. It should also be understood that variations of the exemplary embodiments contemplated by those skilled in the art shall also constitute part of the present disclosure. However, for clarity and precision, the exemplary embodiments as discussed below may include optional steps, methods, and features, which those skilled in the art should recognize as not being necessary to fall within the scope of the present disclosure.

[0033] The present disclosure includes, among other things, medical instruments and devices for performing surgical procedures, and more particularly, delivery devices (e.g., cannulas, etc.) and related methods for surgical procedures. Some exemplary embodiments according to at least some aspects of the present disclosure can be useful in connection with minimally invasive procedures. For example, some exemplary embodiments can be used in connection with ablation of cardiac tissue, such as to treat cardiac arrhythmias, such as atrial fibrillation.

[0034] FIG. 1 is a simplified schematic diagram of an exemplary delivery device 100 according to at least some aspects of the present disclosure. Some exemplary delivery devices 100 can be configured for use in a surgical procedure, such as, for example, delivering one or more therapeutic devices 10, 12 and / or one or more visualization devices 14 to a surgical site 16 in a patient's body 18. The exemplary therapeutic devices 10, 12 can include ablation devices, biopsy devices, pericardial leads, needles for delivering therapeutic agents, surgical tools, and the like. The exemplary visualization devices 14 can include endoscopes and other similar instruments. In some exemplary embodiments, the separate visualization device 14 can be replaced by a chip-on-tip feature that can include a digital imaging device disposed generally distally on the delivery device 100 (e.g., generally where an endoscope would appear, etc.).

[0035] In some exemplary embodiments, the delivery device 100 can include a handle 102, which can be disposed proximally and / or which can remain generally outside the patient's body 18. As used herein, "proximal" may generally refer to a direction toward an operator of a system or device (e.g., a cardiac surgeon or interventional cardiologist) (e.g., a direction away from the furthest end of the device that is inserted into the patient's body). The proximal direction is indicated by arrow 2 in the drawings. The delivery device 100 can include an elongated shaft 104, which can extend distally from the handle 102. As used herein, "distal" may generally refer to a direction away from an operator of a system or device (e.g., a cardiac surgeon or interventional cardiologist) (e.g., a direction toward the furthest end of the device that is inserted into the patient's body). The distal direction is indicated by arrow 4 in the drawings. At least a portion of the shaft 104 can be inserted into the patient's body 18, for example, proximate the surgical site 16. The handle 102 and / or shaft 104 can include one or more generally longitudinal lumens 106, 108 extending therethrough. The working ends 11, 13, 15 of the therapeutic devices 10, 12 and / or visualization component 14 can be delivered to the surgical site through one or more of the lumens 106, 108.

[0036] Some exemplary embodiments may include one or more space creating elements 110, which may be disposed proximate a distal end portion 112 of the shaft 104. In various exemplary embodiments, the space creating elements 110 may be configured to create or expand a working space 20, such as by separating biological tissue 22 at the surgical site 16, which may facilitate visualization of the surgical site 16 (e.g., by one or more visualization devices 14) and / or use of one or more therapeutic devices 10, 12 at the surgical site 16. For example, use of the space creating elements 110 may facilitate positioning of the therapeutic devices 10, 12 and / or facilitate visualization of the patient's anatomy and / or the therapeutic devices 10, 12 using the visualization device 14. Some space-creating elements 110 can be configured with a low profile to facilitate introduction / maneuverability into tight spaces and / or can be configured to be substantially atraumatic in various anticipated conditions of use. In some exemplary embodiments, the space-creating elements 110 can be fixedly and / or rigidly disposed proximate the distal end portion 112 of the shaft 104. In some exemplary embodiments, the space-creating elements 110 can be movably and / or reconfigurably disposed proximate the distal end portion 112 of the shaft 104.

[0037] The foregoing description of the exemplary delivery device 100 provides a context for the various exemplary embodiments described below. The various exemplary embodiments described below may include components of the exemplary delivery device 100 or may be utilized in alternative arrangements. The following description of the various exemplary embodiments may focus on differences between the various exemplary configurations. Descriptions of aspects or features common among several embodiments will not be repeated for the sake of brevity. Thus, it should be understood that various aspects, features, and attributes described in connection with any embodiment may also pertain to other embodiments, whether or not explicitly described below. More generally, any feature or component of any exemplary embodiment described herein may be utilized in connection with any other embodiment, and repeated descriptions of similar components are omitted for the sake of brevity.

[0038] FIG. 2 is a perspective view of an exemplary delivery device 200 according to at least some aspects of the present disclosure. The delivery device 200 can include a handle 202 and a shaft 204. In some exemplary embodiments, any portion of the shaft 204 (e.g., the distal end portion 206 of the shaft 204) can be steerable in one or more planes 208, 210, which can be generally vertical. As used herein, "steerable" in the context of a shaft can describe a deformable shaft (or a portion thereof) that can be actively steered (e.g., bent or articulated) using an actuator. As used herein, "deformable" in the context of a shaft can describe a shaft that is configured to change shape when subjected to forces expected during normal operation of the delivery device. Some exemplary embodiments can be steerable in one or both directions in the respective planes. Some unidirectionally steerable embodiments may be steerable in one direction from a generally central position in a particular plane (e.g., steerable to the left but not to the right, and / or steerable down but not up). Some embodiments may be steerable bidirectionally (e.g., left and right, and / or up and down). Some exemplary embodiments may be bidirectionally steerable in two generally perpendicular planes (e.g., left-right and up-down). In some exemplary embodiments, steerability in one or more planes may be symmetrical or asymmetrical. For example, some asymmetrically steerable embodiments may be steerable to a different degree and / or with a different curvature in one direction (e.g., left) than in the opposite direction (e.g., right).

[0039] Some exemplary embodiments may include one or more actuators 212, 214 configured to steer one or more portions of the shaft (e.g., the distal end portion 206, etc.). For example, the actuators 212, 214 may be disposed on the handle 202 for actuation by a user. In some exemplary embodiments, the actuators 212, 214 may be operably coupled to the distal end portion 206 by one or more wires, which may facilitate steering the distal end portion 206. Some exemplary embodiments may include, for example, one to four pull wires for actuating deflection of the distal end portion 206. Some exemplary embodiments may include one or more actuators 216 configured to rotate certain components of the delivery device 200. Some exemplary embodiments may include one or more strain relief elements (e.g., strain relief element 218 proximate the interface between the handle 202 and the shaft 204, etc.).

[0040] In some exemplary embodiments, any portion of the shaft 204 (e.g., the distal end portion 206 of the shaft 204) can be deformable (e.g., flexible, etc.). As used herein, "flexible" in the context of a shaft can describe a shaft that is easily passively (elastically and / or plastically) bendable by directly applying forces expected during normal operation to the shaft. For example, a user can directly apply bending or bending forces to the shaft 204, or an anatomical structure through which the shaft 204 is directed can directly apply bending or bending forces to the shaft 204. In contrast, as used herein, "rigid" in the context of a shaft can describe a shaft that is not easily and significantly deformable under forces expected during normal operation. In various exemplary embodiments, the shaft 204 can be flexible in one direction and / or in both directions, and symmetrically and / or asymmetrically, as described above with respect to steerability.

[0041] 3 is a simplified cross-sectional view of an exemplary delivery device 300 according to at least some aspects of the present disclosure. The delivery device 300 can include a shaft 302 disposed distally over a handle 304. In the illustrated embodiment, the shaft 302 can be generally flexible. In some exemplary embodiments, the shaft 302 can have a substantially uniform flexibility (or stiffness) along its longitudinal length 304.

[0042] In some exemplary embodiments, the flexibility (or stiffness) of the shaft 302 may vary longitudinally along the shaft. For example, the shaft 302 may include multiple zones (or portions thereof) having different flexibility (e.g., a proximal zone 306, an intermediate zone 308, and / or a distal zone 310, etc.). In some exemplary embodiments, the shaft 302 may be relatively stiffer in the proximal zone 306, relatively softer in the intermediate zone 308, and / or most flexible in the distal zone 310. Some exemplary embodiments may include discrete zones 306, 308, 310 with distinct and / or abutting boundaries. Other exemplary embodiments may include spaced apart and / or gradual transitions between the zones 306, 308, 310, or may even include gradual changes along all or a substantial portion of the shaft 302.

[0043] In some exemplary embodiments, varying the flexibility (or stiffness) over the length 304 of the shaft 302 can be facilitated by varying the thickness of the tubular component that comprises the shaft 302 along its length 304. For example, the shaft 302 can include a polymeric overjacket 312. The overjacket 312 can be thickest in the proximal zone 306, thinner in the intermediate zone 308, and / or thinnest in the distal zone 310.

[0044] In some exemplary embodiments, varying the flexibility (or stiffness) over the length 304 of the shaft 302 can be facilitated by varying the mechanical properties of the overjacket 312 along its length 304. For example, the overjacket 312 can have a relatively hard durometer in the proximal zone 306, a softer durometer in the intermediate zone 308, and a relatively soft durometer in the distal zone 310.

[0045] In some exemplary embodiments, varying the flexibility (or stiffness) over the length 304 of the shaft 302 can be facilitated by varying the construction of the structural components 314 of the shaft 302 along its length 304. For example, the shaft 302 can include braided wires (e.g., about 16 wires arranged in a crisscross (braided) pattern) as the structural components 314. In some embodiments, the braided wire structural components can be generally in the form of a braided tube. The braid pattern and / or tightness of the weave can vary along the length to provide different shaft 302 flexibility (or stiffness). As another example, the shaft 302 can include a tube with a laser cut pattern therein as the structural components 314. The laser cut pattern can vary along the length 304 of the shaft 302 to provide the desired flexibility (or stiffness) characteristics.

[0046] In some exemplary embodiments, the steerable shaft may be configured similarly to shaft 302, i.e., the steerability of the shaft may vary over the length of the shaft, as generally described above with reference to FIG.

[0047] FIG. 4 is a perspective view of an exemplary handle 400 of an exemplary delivery device according to at least some aspects of the present disclosure. In FIG. 4, the handle 400 is shown to be used with a visualization device (such as, for example, an endoscope 402) and a therapeutic device 404. The visualization device can be received in a minor lumen of the delivery device, and / or the therapeutic device 404 can be received in a main lumen of the delivery device. Also shown is a lumen 406 and a connector 406A operably connected to supply and / or remove inflation fluid (e.g., gas and / or liquid) from one or more space-making elements including an inflatable element through the lumen of the delivery device. In some exemplary embodiments, the lumen 406 can be connected to a vacuum source to provide suction functionality. In some exemplary embodiments, the lumen 406 can be provided with a stopcock operable to allow selection between fluid injection and vacuum suction. Also shown is a lumen 408 configured for fluid management, such as supplying or removing fluid proximate the surgical site 16 through the lumen of the delivery device. In this exemplary embodiment, the handle 400 can include a plurality of actuators 410 that can be operable to steer one or more portions of the shaft of the delivery device via a deflection mechanism that can be at least partially disposed within the handle. Some exemplary handles 400 can be shaped in a generally ergonomic manner.

[0048] 5A-5G are distal perspective views of various alternative exemplary rigid and / or fixed space-creating elements that can be disposed distally on a delivery device, all according to at least some embodiments of the present disclosure. As illustrated in FIGS. 5A-5G, the various space-creating elements can include openings associated with lumens in the delivery device (e.g., a lumen for a therapeutic device, a lumen for a movable space-creating element such as an inflatable element, an aspiration lumen, and / or a lumen for a visualization device). FIG. 5A illustrates a space-creating element 502 generally in the form of a right circular cylinder having a cross-sectional shape that generally matches the cross-sectional shape of a shaft 504. FIG. 5B illustrates a space-creating element 506 in the form of a generally deep angled hood that extends from only a portion of a distal end surface 508 of a shaft 510. FIG. 5C illustrates a space-creating element 512 in the form of a generally shallow angled hood that extends from only a portion of a distal end surface 514 of a shaft 516. FIG. 5D illustrates a space-making element 518 in the form of a generally deep angled hood having a shape different from that of the shaft 520. FIG. 5E illustrates a space-making element 522 in the form of a generally shaped distal end portion of a shaft 524. FIG. 5F illustrates a space-making element 526 in the form of a generally flat distal end surface of a shaft 528. In some exemplary embodiments, the distal end portion (e.g., the flat distal end surface, etc.) can have a relatively larger diameter than the diameter of the proximal component (e.g., shaft). The relative diameter difference can act as a space-making element to provide better visibility at the surgical site. FIG. 5G illustrates a space-making element 530 in the form of a generally elongated cylinder 532 with an angled tip 534. Additionally, the illustrated embodiment includes a longitudinal slot disposed proximate to the short side of the angled tip.

[0049] 6A and 6B are simplified cross-sectional views of a distal portion of a delivery device 600 including an exemplary expandable space-creating element 602, all according to at least some embodiments of the present disclosure. In general, the expandable space-creating element 602 may be reconfigurable between a contracted (contracted) configuration (FIG. 6A) and an expanded (expanded and / or deployed) configuration (FIG. 6B). The expandable space-creating element 602 can be used to create or expand the working space 20.

[0050] In some exemplary embodiments, in the collapsed configuration, the expandable space-creating element 602 can have a width 604 (e.g., diameter) that is approximately the same as the width (e.g., diameter) of the shaft 606. In the expanded configuration, the expandable space-creating element 602 can have a width 604 that is substantially greater than the width (e.g., diameter) of the shaft 606. The expandable space-creating element 602 can be expandable laterally and / or radially. In some exemplary embodiments, in the collapsed configuration, the expandable space-creating element 602 can not extend substantially distally beyond the distal end portion 608 of the shaft 606. In some exemplary embodiments, in the expanded configuration, the expandable space-creating element 602 can extend substantially distally beyond the distal end portion 608 of the shaft 606. The expandable space-creating element 602 can be expandable longitudinally and / or axially. In some exemplary embodiments, the expandable space-creating element 602 may be laterally / radially expandable and / or longitudinally / axially expandable.

[0051] In some exemplary embodiments, in the collapsed configuration, the expandable space-creating element 602 can be generally concentrically disposed within the distal end portion 608 of the shaft 606, such as by folding and / or folding generally radially inward and / or proximally. The interior of the distal end portion 608 of the shaft 606 can include a generally circumferential recess 610 that can receive at least a portion of the collapsed expandable space-creating element 602.

[0052] In some exemplary embodiments, fluid (e.g., gas and / or liquid) can be supplied to and / or removed from the expandable space creating element 602 via lumen 612, which can be referred to as an inflation lumen. The exemplary delivery device can include other lumens, such as a device lumen 614 (e.g., for the therapeutic devices 10, 12), a scope lumen 616 (e.g., for the visualization device 14), and / or a suction lumen, etc.

[0053] Some exemplary embodiments may include a distally positioned obturator (such as, for example, an expandable obturator 618). In some exemplary embodiments, the expandable obturator 618 may include a generally rounded and / or generally blunt distal tip portion 620. In some exemplary embodiments, the expandable obturator 618 may be positioned proximate the distal end portion 608 of the shaft 606 via a lumen (such as, for example, the device lumen 614). In use, the delivery device 600 may be directed to and / or positioned at the surgical site with the obturator 618 positioned distally on the shaft, as shown in FIG. 6A. The obturator 618 may then be deflated and / or withdrawn proximally, leaving other portions of the delivery device 600 in place, as shown in FIG. 6B. In some exemplary embodiments including a selectively removable obturator 618, the obturator 618 can be removed from the delivery device 600 and / or the lumen 614 can be utilized to deliver other instruments (e.g., therapeutic devices) to the surgical site.

[0054] FIG. 6C is a simplified side view of a distal portion of a delivery device 650 including an exemplary expandable space creating element 652 in a contracted configuration and an expandable obturator 668 in an expanded configuration, and FIG. 6D is a simplified cross-sectional view of a distal portion of the delivery device 650 with the expandable space creating element 652 in an expanded configuration, all according to at least some aspects of the present disclosure. In general, the delivery device 650, the expandable space creating element 652, and the obturator 668 can be similar to the delivery device 600, the expandable space creating element 602, and the obturator 618 described above with reference to FIGS. 6A and 6B, and repeated descriptions of similar elements have been omitted for brevity. However, in the embodiment of FIGS. 6C and 6D, the expandable space creating element 652 can be configured to be folded generally radially inward (e.g., generally radially inward relative to the obturator 668, etc.). That is, in the illustrated embodiment, in the collapsed / contracted configuration, this expandable space-creating element 652 may not be generally concentrically foldable and / or collapsible into the distal end portion of the shaft by folding generally radially inward and proximally.

[0055] 6D, the delivery device 650 can include a distal cap 654 that can be configured to organize the various lumens of the delivery device 650 and / or can act as a manifold to fluidly connect one or more inflation lumens 662A, 662B to the expandable space creating element 652 via one or more internal inflation conduits 662C, 662D. The distal end cap 654 can accommodate various lumens, such as one or more lumens for suction and / or one or more lumens for a visualization device. In the illustrated embodiment, the expandable space creating element 652 can be constructed generally in the form of a double-walled balloon, which can be molded as a single piece in a folded manner to create an internal chamber.

[0056] 7A is a simplified cross-sectional view of a distal portion of an exemplary delivery device 700, and FIG. 7B is a distal view of the delivery device 700, all according to at least some aspects of the present disclosure. The delivery device 700 may generally differ from the delivery devices 600, 650 in that the delivery device 700 is capable of creating a space proximal to the scope, while the delivery devices 600, 650 are capable of creating a space 20 in the manner of a hollow core, such that the scope resides within the boundaries of the expandable space-creating elements 602, 652. Specifically, in the illustrated embodiment, the delivery device includes one or more expandable space-creating elements 702, 704, which may be disposed proximally from where the scope 706 emerges. In this embodiment, the therapeutic device 708 emerges laterally adjacent to the scope 706.

[0057] 8 is a distal perspective view of an example delivery device 800 according to at least some embodiments of the present disclosure. The delivery device 800 can include a shaft 802, a handle 804, and / or a space-creating element 806. The space-creating element 806 can be disposed generally distally on the shaft 802 (e.g., on a distal end portion 808 on the shaft 802, etc.).

[0058] In some exemplary embodiments, the space creating element 806 can include a selectively deployable skirt movable between a retracted configuration, an intermediate configuration, and / or an extended configuration. For example, a skirt similar to that described in U.S. Patent Application Publication No. 2007 / 0139994, which is incorporated by reference herein in its entirety, can be utilized in some exemplary embodiments according to at least some aspects of the present disclosure. In some exemplary embodiments according to at least some aspects of the present disclosure, the delivery device 800 can be configured for space creation at the posterior aspect of the patient's heart.

[0059] FIG. 9 is a perspective view of a distal portion of an exemplary delivery device 900 including a movable space-creating element 902, all according to at least some aspects of the present disclosure. In some exemplary embodiments, the space-creating element 902 can include an expandable element 904. The expandable element 904 can be movable relative to a distal end portion 906 of a shaft 908 of the delivery device 900. For example, the expandable element 904 can be disposed over a guidewire 910, which can be guided through a lumen of the delivery device 900. The guidewire 910 can be extended and / or retracted to position the expandable element 904 as desired. In some exemplary embodiments, the expandable element 904 can include an inflatable element (e.g., a balloon, etc.). In some exemplary embodiments, the inflatable element can be operably connected to a source of inflation fluid via a lumen 912. In some exemplary embodiments, a therapeutic element 914 can be delivered via the delivery device 900.

[0060] Figure 10 is a simplified side view of a distal portion of an exemplary delivery device 1000 according to at least some aspects of the present disclosure. This exemplary embodiment is generally similar to the embodiment illustrated in Figure 9. In this exemplary embodiment, a guidewire 1002 can extend between a therapeutic element 1004 and a movable expandable element 1006.

[0061] 11 is a simplified side view of a distal portion of an exemplary delivery device 1100 according to at least some aspects of the present disclosure. This exemplary embodiment is generally similar to the embodiment illustrated in FIGS. 9 and 10. In this exemplary embodiment, a guidewire may not be used. Thus, in some exemplary embodiments, the movable expandable element 1102 can be coupled to the shaft 1104 via only the lumen 1106.

[0062] 12A is a simplified side view of a distal portion of an exemplary delivery device 1200, and FIG. 12B is a distal view of the delivery device 1200, all according to at least some aspects of the present disclosure. This exemplary embodiment can be generally similar to the embodiment illustrated in FIG. 11. Some exemplary embodiments can include two or more expandable elements (e.g., inflatable expandable elements 1202, 1204, etc.). In some exemplary embodiments, a therapeutic device 1206 can be generally positioned between the inflatable expandable elements 1202, 1204.

[0063] In some alternative exemplary embodiments, one or more expandable elements (e.g., inflatable expandable elements, etc.) can be disposed over the stylet instead of or in addition to the guidewire. In some alternative embodiments, mechanically expandable elements can be utilized instead of or in addition to the inflatable expandable elements. More generally, inflatable and / or mechanically expandable elements can be disposed over the guidewire and / or stylet in various exemplary embodiments according to at least some aspects of the present disclosure.

[0064] 1, various exemplary delivery devices 100 according to at least some aspects of the present disclosure can include one or more lumens 106, 108 that are configured to receive one or more visualization devices 14 therethrough. In some exemplary embodiments, one or more of the lumens 106, 108 can be specialized specifically for use with one or more visualization devices 14 (e.g., an endoscope, etc.).

[0065] Some exemplary embodiments can be configured to rotationally reposition one or more lumens 106, 108 relative to the handle 102. FIG. 13A is a simplified cross-sectional view of an exemplary shaft 1300 according to at least some aspects of the present disclosure. In this exemplary embodiment, the shaft 1300 can include a therapeutic device lumen 1302 and / or a visualization device lumen 1304, as well as other lumens as described herein. The lumens 1302, 1304 can be disposed within an inner shaft portion 1306. The inner shaft portion 1306 can be concentrically or eccentrically disposed within an outer shaft portion 1308. In some exemplary embodiments, the inner shaft element 1306 can be rotatable generally about a longitudinal axis of the shaft 1300. In some exemplary embodiments, the outer shaft element 1308 can be steerable in one or more directions. FIG. 13B is a perspective view of a distal end portion of the shaft 1300 of FIG. 13A.

[0066] 14 is a simplified cross-sectional view of an exemplary shaft 1400 according to at least some aspects of the present disclosure. In this exemplary embodiment, the shaft 1400 can include a therapeutic device lumen 1402 and / or a visualization device lumen 1404. The shaft 1400 can include an inner shaft portion 1406 and / or an outer shaft portion 1408. In some exemplary embodiments, the inner shaft portion 1406 can be steerable. In some exemplary embodiments, the outer shaft portion 1408 can have a generally circular circumferential circumference. The therapeutic device lumen 1402 can be disposed within the inner shaft portion 1406. The visualization device lumen can be disposed within the outer shaft portion 1408. The outer shaft portion can be rotatable about the inner shaft portion 1406. In some exemplary embodiments, the inner shaft portion 1406 can be non-concentrically disposed with the outer shaft portion 1408. In some exemplary embodiments, a central axis 1410 of the inner shaft portion 1406 can be laterally offset from a central axis 1412 of the outer shaft portion 1408. In some exemplary embodiments, the outer shaft portion 1408 can be eccentrically rotated relative to the inner shaft portion 1406.

[0067] FIG 15A is a simplified cross-sectional view of an exemplary shaft 1500 according to at least some aspects of the present disclosure. The exemplary shaft 1500 can be generally similar to the embodiment described above with reference to FIG 14. In some exemplary embodiments, the shaft 1500 can include an outer shaft portion 1502 having a non-circular outer circumference. In some exemplary embodiments, the shaft 1500 can have a maximum outer width 1504 in one direction that is substantially greater than a maximum outer width 1506 in a perpendicular direction. FIG 15B is a perspective view of a distal end portion of the shaft 1500 of FIG 15A.

[0068] Some exemplary embodiments may include one or more lumens that may be utilized for purposes other than receiving visualization and / or therapeutic devices. For example, some embodiments may include one or more separate lumens configured for infusion and / or withdrawal (e.g., aspiration) of fluids during a procedure.

[0069] Some exemplary embodiments according to at least some aspects of the present disclosure may include features configured to synchronize movement of therapeutic and / or visualization devices. For example, features for synchronizing an endoscope and a delivery device (e.g., a cannula) may include a Tuohy-Borst style fitting or a locking brake mechanism that temporarily or permanently grips a section of the endoscope shaft until released by a handle feature. In other exemplary embodiments, such features may include a cradle receiver for a scope head. FIG. 16 is a simplified cross-sectional view of a delivery device 1600 and an endoscope 1602 according to at least some aspects of the present disclosure. The delivery device 1600 may include one or more active locking brake mechanisms 1604. In some exemplary embodiments, the locking brake mechanism 1604 may include an arm 1608 biased by a spring 1606 and pivotally disposed. One end of the arm 1608 may be spring biased to releasably engage the endoscope 1602. An opposite end of the arm 1608 may be accessible to a user. For example, when the opposite end of the arm 1608 is depressed, the arm 1608 can pivot to release from the endoscope 1602. In an alternative embodiment, a passive lock can be utilized to releasably couple the delivery device 1600 and the endoscope 1602.

[0070] Fig. 17 is a top view of an exemplary delivery device 1700, Fig. 18 is a proximal perspective view of the delivery device 1700 of Fig. 17, Fig. 19 is a detailed distal perspective view of the delivery device 1700 of Fig. 17, Fig. 20 is a detailed distal perspective cross-sectional view of the shaft of the delivery device 1700 of Fig. 17, Fig. 21 is a proximal perspective view of structural components of the shaft of the delivery device 1700 of Fig. 17, and Fig. 22 is a detailed perspective view of a distal end portion of structural components of the shaft of the delivery device 1700 of Fig. 17, all according to at least some aspects of the present disclosure. In general, it will be understood that the delivery device 1700 is an exemplary combination of various features described throughout this disclosure, and that any alternative features described elsewhere herein can be utilized in generally similar alternative embodiments.

[0071] 17 and 18 , in the illustrated embodiment, a delivery device 1700 can include a proximally disposed handle 1702, an elongate shaft 1704 extending distally from the handle 1702, and / or a space creating element 1706 disposed distally on a distal end portion 1708 of the shaft 1704. The distal end portion 1708 can be disposed distally relative to a proximal portion 1709 of the shaft 1704.

[0072] 17-19, in the illustrated embodiment, the space-creating element 1706 can include a reconfigurable space-creating element (e.g., an expandable space-creating element, etc.). In FIGS. 17-19, the expandable space-creating element is shown in an expanded (e.g., deployed and / or expanded) configuration. The expandable space-creating element 1706 can be reconfigured to a contracted (e.g., collapsed) configuration as described elsewhere herein. In some exemplary embodiments, at least a portion 1710 of the expandable space-creating element 1706 can be generally in the form of a right circular cylinder, which can be disposed generally coaxially with the shaft 1704. The expandable space-creating element 1706 can be expandable to have an expanded diameter 1712 that is substantially larger than a diameter 1714 of the shaft 1704. In the illustrated embodiment, the expandable space creating element 1706 includes a distal end surface 1716 that is generally perpendicular to the cylindrical portion 1710 of the expandable space creating element 1706. The expandable space creating element 1706 can include a generally conically tapered transition portion 1718 interposed between the cylindrical portion 1710 and the shaft 1704. In the illustrated embodiment, the expandable space creating element 1706 can be constructed with a single internal expandable chamber. In other illustrative embodiments, the expandable space creating element 1706 can be constructed with two or more fluidly separated internal expandable chambers.

[0073] With reference to Figures 19 and 20, in the illustrated embodiment, the shaft 1704 can include multiple longitudinally oriented lumens (e.g., one or more therapeutic device lumens 1720, one or more visualization device lumens 1722, one or more suction lumens 1724, 1726, one or more steering lumens 1728, 1730, and / or one or more inflation lumens 1732, 1734, etc.).

[0074] In the illustrated embodiment, the steering wires 1736, 1738 are movably disposed within their respective steering lumens 1728, 1730. In other embodiments, the steering wires 1736, 1738 can be guided through the shaft 1704 without the steering lumens 1728, 1730 and / or mechanical connectors other than wires (e.g., rods, cables, etc.) can be utilized in place of the steering wires 1736, 1738.

[0075] In some exemplary embodiments, one or more of the suction lumens 1724, 1726 can be used to deliver fluid to the surgical site (e.g., for irrigation, etc.). Similarly, in some exemplary embodiments, one or more of the inflation lumens 1732, 1734 can be used to remove inflation fluid from the expandable space creating element 1706.

[0076] In the illustrated embodiment, the various lumens 1720, 1722, 1724, 1726, 1728, 1730, 1732, 1734 can be aligned generally straight and generally parallel along the longitudinal axis of the shaft 1704. In alternative embodiments, one or more of the lumens 1720, 1722, 1724, 1726, 1728, 1730, 1732, 1734 can be disposed in a non-straight and / or non-parallel orientation.

[0077] 20-22 , in the illustrated embodiment, the shaft 1704 can include a generally tubular outer jacket 1740, which can be formed from a thermoplastic elastomer, such as, for example, a polyether block amide (e.g., PEBA). The shaft 1704 can include a structural component 1742 that is at least partially radially disposed within the jacket 1740. In the illustrated embodiment, the structural component 1742 can include a laser cut stainless steel hypotube 1744.

[0078] 21-22, the hypotube 1744 can be generally in the form of an elongated tubular right cylinder. The hypotube 1744 can include a plurality of solid portions 1746 and / or a plurality of gaps 1748. In some exemplary embodiments, the solid portions 1746 and the gaps 1748 can be arranged in a generally alternating pattern along the length of the hypotube 1744. In some exemplary embodiments, the size, shape, location, and / or orientation of the solid portions 1746 and / or gaps 1748 (or other attributes of the hypotube 1744) can be different in different portions 1750, 1752 of the hypotube 1744 and / or can vary gradually over the length of the hypotube 1744.

[0079] In the illustrated embodiment, the proximal portion 1750 of the hypotube 1744 (which may correspond to the proximal portion 1709 of the shaft 1704 (FIGS. 17-18)) can be configured to allow up-down bending while preventing substantial left-right bending. In the illustrated embodiment, the left-right plane can be substantially perpendicular to the up-down plane. Specifically, in the illustrated embodiment, the upper and lower portions of the proximal portion 1750 can include generally circumferentially disposed gaps 1748 that are laterally oriented and / or the left and right portions of the proximal portion 1750 can be substantially solid. In the illustrated embodiment, the upper and lower portions of the proximal portion 1750 can be generally symmetrical, thus allowing symmetric bidirectional bending. In some alternative embodiments, the upper and lower portions of the proximal portion 1750 can be different to provide unidirectional bending and / or asymmetric bending.

[0080] In the illustrated embodiment, the distal portion 1752 of the hypotube 1744, which may correspond to the distal portion 1708 of the shaft 1704 (FIGS. 17-18), may be configured to allow side-to-side bending while preventing substantial up-down bending. Specifically, in the illustrated embodiment, the left and right portions of the distal portion 1752 may include generally circumferentially disposed gaps 1748 that are laterally oriented and / or the upper and lower portions of the distal portion 1752 may be substantially solid. In the illustrated embodiment, the upper and lower portions of the distal portion 1752 may be generally symmetrical, thus allowing symmetric bidirectional bending. In some alternative embodiments, the upper and lower portions of the distal portion 1752 may be different to provide unidirectional bending and / or asymmetric bending.

[0081] In some alternative embodiments, the hypotube 1744 can include more than two portions (e.g., a proximal portion 1750 and a distal portion 1752). In some alternative embodiments, the hypotube 1744 can be configured to bend in a non-perpendicular plane. In some alternative embodiments, different portions 1750, 1752 of the hypotube 1744 can be configured to bend in substantially the same plane (e.g., to different extents and / or in generally opposite directions).

[0082] 17, 18, and 22, in the illustrated embodiment, the proximal portion 1709 of the shaft 1704 of the delivery device 1700 can be generally flexible in an up-down direction, such as, for example, in a generally vertical plane 1754. In the illustrated embodiment, the distal portion 1708 of the shaft 1704 can be steerable in a left-right direction, such as, for example, in a generally horizontal plane 1756, by operation of an actuator 1758 disposed on the handle 1702. The actuator 1758 can be operatively connected to steer the distal portion 1708 of the shaft 1704 by one or more mechanical connectors (e.g., steering (pull) wires 1736, 1738, etc.). The pull wires 1736, 1738 can be coupled to opposite (e.g., left and right) sides of a distally positioned pull ring 1764. In operation, the actuator 1758 can be rotated to pull one of the pull wires 1736, 1738, which can cause a corresponding portion of the pull ring 1764 to move proximally, thus causing the distal portion 1708 of the shaft 1704 to steer generally toward the pulled pull wire 1736, 1738.

[0083] 17 and 18, the handle 1702 can include a locking actuator 1766. The locking actuator 1766 can be operable (e.g., rotatable) to lock and unlock the steering actuator 1758. Thus, the distal portion 1708 of the shaft 1704 can be maintained in a partially or fully steered position.

[0084] In some alternative exemplary embodiments, the distal portion 1708 of the shaft 1744 can be generally flexible in the up-down and / or side-to-side directions when the pull wires 1736, 1738 are not tensioned (e.g., by the actuator 1758). In use, such embodiments can be steered (e.g., by the actuator 1758) during some parts of a procedure and / or bent (without active steering) during other parts of a procedure. For example, steering can be used to actively orient the distal portion 1708 of the shaft 1704 while the delivery device 1700 is guided to the posterior side of the patient's heart. The pull wires 1736, 1738 can then be released and the distal portion 1708 of the shaft 1704 can be repositioned in a passive bent configuration when the delivery device 1700 is positioned at a surgical site near the superior portion of the patient's heart. In some embodiments, the adjacent patient anatomy can constrain movement of the distal portion 1708 in one or more directions.

[0085] 18 and 20, the delivery device 1700 can include one or more interface elements associated with one or more components of the delivery device 1700. For example, the therapeutic device lumen 1720 and / or the visualization device lumen 1722 can be operatively connected to a proximal port 1768, which can be disposed proximally on the handle 1702. The proximal port 1768 can allow for insertion of a therapeutic device and / or a visualization device into their respective lumens 1720, 1722. In the illustrated embodiment, the therapeutic device lumen 1720 and the visualization device lumen 1722 can come together in a wye in the handle 1702. Thus, the proximal port 1768 provides access to both the therapeutic device lumen 1720 and the visualization device lumen 1722. In some exemplary embodiments, the proximal port 1768 can include a hemostasis valve configured to restrict the flow of fluid through the proximal port 1768 to and / or from the therapeutic device lumen 1720 and / or the visualization device lumen 1722. In alternative embodiments, each of the therapeutic device lumen 1720 and the visualization device lumen 1722 can be provided with a separate proximal opening. In the illustrated embodiment, the therapeutic device lumen 1720 can be fluidly connected to a proximal fluid conduit 1723 and / or a fluid connector 1725.

[0086] In the illustrated embodiment, the suction lumens 1724, 1726 can be fluidly connected to a respective proximal suction conduit 1770, 1772 and / or a respective suction connector 1774, 1776. In some alternative embodiments, two or more suction lumens 1724, 1726 can be fluidly coupled to one proximal suction conduit 1770, 1772 and / or suction connector 1774, 1776. Similarly, in some alternative embodiments, two or more suction conduits 1770, 1772 and / or suction connectors 1774, 1776 can be fluidly coupled to one suction lumen 1724, 1726.

[0087] In the illustrated embodiment, the inflation lumens 1732, 1734 can be fluidly connected to a respective proximal inflation conduit 1778, 1780 and / or a respective inflation connector 1782, 1784. In some alternative embodiments, two or more inflation lumens 1732, 1734 can be fluidly coupled to a single proximal inflation conduit 1778, 1780 and / or inflation connector 1782, 1784. Similarly, in some alternative embodiments, two or more inflation conduits 1778, 1780 and / or inflation connectors 1782, 1784 can be fluidly coupled to a single inflation lumen 1732, 1734.

[0088] Some exemplary embodiments can include lumens for additional purposes (e.g., accessory lumens for additional accessory surgical tools, etc.). Some such accessory lumens can be generally similar in structure to the suction lumens 1724, 1726 illustrated in FIG. 20, but the proximal ends can be configured to receive accessory surgical tools therethrough, similar to the therapeutic device lumen 1720 and / or visualization device lumen 1722. Similarly, in some exemplary embodiments utilizing a chip-on-tip visualization device configuration, the lumen 1722 described above as a visualization lumen can be utilized as an accessory lumen.

[0089] In some exemplary embodiments, the expandable elements described herein can be constructed from, for example, polyether block amides (e.g., PEBA), polyvinyl chloride (e.g., PVC), polyethylene terephthalate (e.g., PET), and / or urethane.

[0090] 23 is a proximal perspective view of an alternative exemplary expandable space-making element 1800 including circumferential ribs, according to at least some aspects of the present disclosure. The expandable space-making element 1800 can be utilized in place of other space-making elements described herein (such as, for example, the space-making element 1706 of the embodiment of FIG. 17). The expandable space-making element 1800 can include a proximal portion 1802 configured to operably couple to a delivery device shaft and a distally disposed expandable portion 1804. The expandable portion 1804 can be configured with a plurality of generally circumferentially oriented ribs 1806. The ribs 1806 can be formed by generally circumferentially disposed secondary welds 1808 connecting radially inner and outer walls of the expandable portion 1804.

[0091] 24 is a proximal perspective view of an alternative exemplary expandable space-making element 1850 including longitudinal ribs, according to at least some aspects of the present disclosure. The expandable space-making element 1850 can be utilized in place of other space-making elements described herein (such as, for example, the space-making element 1706 of the embodiment of FIG. 17). The expandable space-making element 1850 can include a proximal portion 1852 configured to operably couple to a delivery device shaft and a distally disposed expandable portion 1854. The expandable portion 1854 can be configured with a plurality of generally longitudinally oriented ribs 1856. The ribs 1856 can be formed by generally longitudinally disposed secondary welds 1858 connecting radially inner and outer walls of the expandable portion 1854.

[0092] 25 is a distal perspective view of an alternative exemplary expandable space-creating element 1900 including an orientation feature, according to at least some aspects of the present disclosure. The expandable space-creating element 1900 can be utilized in place of other space-creating elements described herein (e.g., space-creating element 1706 of the embodiment of FIG. 17, etc.). The expandable space-creating element 1900 can include a proximal portion 1902 configured to operably couple to a delivery device shaft and a distally disposed expandable portion 1904. The expandable portion 1904 can include an orientation feature (e.g., notch 1906, etc.). The orientation feature (e.g., notch 1906, etc.) can facilitate determining a rotational orientation of the delivery device, such as, for example, when a distal portion including the expandable portion is viewed through a visualization device (e.g., endoscope).

[0093] 26 is a side view of an alternative exemplary expandable space-creating element 1950 including an angled distal surface, according to at least some aspects of the present disclosure. The expandable space-creating element 1950 can be utilized in place of other space-creating elements described herein (such as, for example, the space-creating element 1706 of the embodiment of FIG. 17 ). The expandable space-creating element 1950 can include a proximal portion 1952 configured to operably couple to a delivery device shaft and a distally disposed expandable portion 1954. The expandable portion 1954 can include a distal surface 1956, which can be angled relative to a plane 1958 perpendicular to a longitudinal axis 1960 of the delivery device shaft. The angled distal surface 1956 can facilitate separation of biological tissues (such as, for example, separating the pericardium from the epicardium).

[0094] FIG. 27 is a simplified side cross-sectional view of an alternative expandable space-creating element 2000 including a plurality of longitudinally oriented expandable elements, and FIG. 28 is a simplified distal end view of the expandable space-creating element 2000 of FIG. 27, all according to at least some aspects of the present disclosure. The expandable space-creating element 2000 can be utilized in place of other space-creating elements described herein (such as, for example, the space-creating element 1706 of the embodiment of FIG. 17). In the illustrated embodiment, the expandable space-creating element 2000 can include a plurality (e.g., three) elongated, longitudinally oriented expandable elements 2002, 2004, 2006. In this embodiment, each expandable element 2002, 2004, 2006 can be generally in the form of an elongated, expanded, generally circular tube having a closed distal end and / or a substantially unexpanded proximal portion that acts as a conduit 2008, 2010, 2012 between the expanded portion and the proximal end that is fluidly coupled to one or more inflation lumens 2014, 2016, 2018. The expandable space-creating element 2000 can include one or more collapsible structural elements 2020, 2022 (e.g., nitinol wires, etc.) configured to facilitate desired spacing and / or positioning of the expandable elements 2002, 2004, 2006. For example, the structural elements 2020, 2022 can form a collapsible nitinol frame.

[0095] FIG. 29 is a simplified side cross-sectional view of an alternative expandable space-creating element 2050 including a plurality of flattened longitudinally oriented expandable elements, and FIG. 30 is a simplified distal end view of the expandable space-creating element 2050 of FIG. 29, all according to at least some aspects of the present disclosure. The expandable space-creating element 2050 can be utilized in place of other space-creating elements described herein (such as, for example, the space-creating element 1706 of the embodiment of FIG. 17). In the illustrated embodiment, the expandable space-creating element 2050 can include a plurality (e.g., four) elongated flattened longitudinally oriented expandable elements 2052, 2054, 2056, 2058. In this embodiment, each expandable element 2052, 2054, 2056, 2058 can be in the form of a generally elongated expanded tube having a generally elliptical cross-section. Each expandable element 2052, 2054, 2056, 2058 can include a closed distal end and / or a substantially unexpanded proximal portion that acts as a conduit between the expanded portion and a proximal end that is fluidly coupled to one or more inflation lumens. The expandable space-creating element 2050 can include one or more collapsible structural elements 2060, 2062 (e.g., flexible tabs, etc.) configured to facilitate a desired spacing and / or positioning of the expandable elements 2052, 2054, 2056, 2058.

[0096] FIG. 31 is a simplified side view of an alternative expandable space-creating element 2100 including a coiled expandable element, and FIG. 32 is a simplified distal end view of the expandable space-creating element 2100 of FIG. 31, all according to at least some aspects of the present disclosure. The expandable space-creating element 2100 can be utilized in place of other space-creating elements described herein (such as, for example, the space-creating element 1706 of the embodiment of FIG. 17). In the illustrated embodiment, the expandable space-creating element 2100 can include one or more elongated generally helically arranged expandable elements 2102, 2104. In this embodiment, each expandable element 2102, 2104 can be in the form of a generally elongated expanded tube having a generally circular cross-section. Each expandable element 2102, 2104 can include a closed distal end and / or a substantially unexpanded proximal portion that acts as a conduit between the expanded portion and a proximal end that is fluidly coupled to one or more inflation lumens. In the illustrated embodiment, the two generally helical expandable elements 2102, 2104 can be arranged in an alternating configuration. The expandable space-making element 2100 can include one or more collapsible structural elements 2106 (e.g., Nitinol wires, etc.) configured to facilitate a desired spacing and / or positioning of the expandable elements 2102, 2104.

[0097] 33 is a distal perspective view of a distal end portion of an alternative delivery device 2200 according to at least some aspects of the present disclosure. In general, the delivery device 2200 is similar to the delivery device 1700 of FIG. 17, but the delivery device 2200 includes a rigid space-making element 2202 instead of the expandable space-making element 1706. In the illustrated embodiment, the rigid space-making element 2202 is generally similar to the rigid space-making elements 518, 530 illustrated in FIGS. 5D and 5G. Some exemplary embodiments including only rigid space-making elements (e.g., no expandable space-making elements) may not include an inflation lumen as described herein in connection with embodiments including an expandable element.

[0098] FIG. 34 is a detailed perspective view of a distal end portion of an alternative exemplary structural component 2250 of a shaft of a delivery device, according to at least some aspects of the present disclosure. The structural component 2250 can include a laser cut stainless steel hypotube, which is generally similar to the structural component 1742 described above with reference to FIGS. 21 and 22. With reference to FIG. 34, in the illustrated embodiment, the solid portions 2252 and / or gaps 2254 can be arranged in a generally spiral manner, such as around a longitudinal axis of the structural component 2250. Thus, the illustrated portion of the shaft can be flexible in all directions. Additionally, in this exemplary embodiment, the solid portions 2252 and / or gaps 2254 can be formed with respective interlocking features 2256, 2258, such as generally in the form of an interlocking jigsaw pattern. Such a configuration can provide substantial flexibility while still providing desired torque, tension, and / or compression capabilities.

[0099] 35 is a top view of an alternative exemplary delivery device 2300 according to at least some aspects of the present disclosure. The delivery device 2300 is generally similar to the delivery device 1700 of FIG. 17, and repeated description has been omitted for brevity. In the illustrated embodiment, the shaft 2302 is configured for multiple bends, such as to facilitate access to a particular surgical site by a therapeutic device delivered therethrough. In the illustrated embodiment, the shaft 2302 is configured with a proximal first generally straight portion 2304, a first bend portion 2306, a second generally straight portion 2308, a second opposing bend portion 2310, a third generally straight portion 2312, a third bend portion 2314, and a distal fourth generally straight portion 2316. In some exemplary embodiments, the various portions of the shaft 2302 can be substantially coplanar. In other exemplary embodiments, one or more of the bends may be in a non-coplanar orientation.

[0100] Some exemplary embodiments may include two or more inflation lumens. For example, some embodiments may include two (or more) generally parallel inflation lumens fluidly connected to the inflatable spacemaker. In embodiments where both inflation lumens are connected to the same internal chamber of the inflatable spacemaker, such an arrangement may facilitate faster inflation and / or deflation of the inflatable spacemaker by allowing for a higher inflation fluid flow rate. In other embodiments, the inflatable spacemaker may include two or more fluidly isolated internal chambers. In some such embodiments, one inflation lumen may be fluidly connected to a first internal chamber and the other inflation lumen may be fluidly connected to a second internal chamber. Thus, each internal chamber may be individually inflated and / or deflated, thus facilitating sequential or simultaneous inflation and / or deflation. Additionally, such embodiments may be capable of being configured where one internal chamber is inflated to a different extent than another internal chamber. That is, each individual internal chamber can be independently deflated, partially inflated, or fully inflated, as desired, to configure the expandable spacemaker in a desired configuration.

[0101] Some exemplary embodiments may include more than one aspiration lumen. For example, some embodiments may include two (or more) generally parallel aspiration lumens. Some such arrangements may provide redundancy in the event of partial or complete blockage of the aspiration lumen.

[0102] 36-39 are perspective views of various alternative exemplary embodiments, all according to at least some aspects of the present disclosure.

[0103] Some exemplary methods of using a delivery device according to at least some aspects of the present disclosure may include one or more of the following acts: A distal end portion 1708 of an elongate shaft 1704 of a delivery device 1700 may be positioned at a desired location (such as, for example, a surgical site 16). A reconfigurable space-creating element 1706 disposed distally on the shaft 1704 may be reconfigured from a retracted configuration to an expanded configuration. A working space 20 may be created or expanded at the desired location using the space-creating element 1706. A working end 11 of a therapeutic device 10 may be directed through the shaft 1704 via a longitudinally extending therapeutic device lumen 1720 to a desired location.

[0104] In some exemplary methods, positioning the distal end portion 1708 of the elongate shaft 1704 of the delivery device 1700 at a desired location can include advancing the shaft 1704 using a handle 1702 disposed proximally on the shaft 1704. The distal end portion 1708 of the shaft 1704 can be steerable by a steering actuator 1758 disposed on the handle 1702. Positioning the distal end portion 1708 of the shaft 1704 of the delivery device 1700 at a desired location can include operating the steering actuator 1758 to steer the distal end portion 1708 of the shaft 1704. Operating the steering actuator 1758 to steer the distal end portion 1708 of the shaft 1704 can include pulling steering wires 1736, 1738 extending longitudinally through the shaft 1704 to deflect the distal end portion 1708.

[0105] In some exemplary methods, the proximal portion 1709 of the shaft 1704 can be flexible in a first plane 1754. Positioning the distal end portion 1708 of the shaft 1704 of the delivery device 1700 at a desired location can include bending the proximal portion 1709 of the shaft 1704 in the first plane 1754. The distal end portion 1708 of the shaft 1704 can be steerable in a second plane 1756, which can be generally perpendicular to the first plane 1754. Positioning the distal end portion 1708 of the shaft 1704 of the delivery device 1700 at a desired location can include steering the distal end portion 1708 of the shaft 1704 in the second plane 1756. The distal end portion 1708 of the shaft 1704 can be flexible in the first plane 1754. Positioning the distal end portion 1708 of the shaft 1704 of the delivery device 1700 at a desired location can include bending the distal end portion 1708 of the shaft 1704 in a first plane 1754 .

[0106] In some exemplary methods, the reconfigurable space creating element 1706 can include an expandable space creating element 1706. Expanding the reconfigurable space creating element 1706 can include delivering an inflation fluid to the expandable space creating element 1706 through inflation lumens 1732, 1734 disposed longitudinally within the shaft 1704.

[0107] In some example methods, expanding the reconfigurable space-making elements 1706 can include laterally expanding the reconfigurable space-making elements 1706. In some example methods, expanding the reconfigurable space-making elements 1706 can include longitudinally expanding the reconfigurable space-making elements 1706.

[0108] In some exemplary methods, positioning the distal end portion 1708 of the elongate shaft 1704 of the delivery device 1700 at a desired location can include positioning the distal end portion 1708 adjacent to the left atrial appendage of the patient's heart. Positioning the distal end portion 1708 adjacent to the left atrial appendage can include advancing the distal end portion 1708 toward the posterior of the patient's heart.

[0109] US Patent Publication No. 2014 / 0139996, issued May 13, 2014, describes an apparatus and method related to diaphragmatic access for surgical access to the heart, and is incorporated herein by reference. It should be understood that the various features and operations disclosed therein can be used in connection with any exemplary embodiment according to at least some aspects of the present disclosure. For example, some features and operations related to the expandable member disclosed therein can be used in connection with any embodiment according to the present disclosure.

[0110] Unless specifically indicated, it will be understood that the structural, functional, and / or methodological description of any illustrative embodiment or any feature or aspect thereof herein may be applied to any other illustrative embodiment. More generally, it is within the scope of the present disclosure to utilize any one or more features or aspects of any one or more other illustrative embodiments described herein in conjunction with any other one or more features or aspects of any other one or more other illustrative embodiments described herein. Thus, any combination of any of the features or aspects of any of the embodiments described herein is within the scope of the present disclosure.

[0111] Following from the above description and summary of the invention, it should be apparent to one skilled in the art that the methods and devices described herein constitute exemplary embodiments according to the present disclosure, but that it should be understood that the scope of the disclosure contained herein is not limited to the precise embodiments described above, and that modifications may be made without departing from the scope of the disclosure. Similarly, it should be understood that it is not necessary to meet any or all of the identified advantages or objectives disclosed herein in order to fall within the scope of the present disclosure, since inherent and / or unforeseen advantages may exist, even if they may not be expressly discussed herein. [Explanation of symbols]

[0112] 2 Proximal direction 4 Distal direction 10 Therapeutic Devices 11 Working end 12 Therapeutic Devices 13 Working end 14 Visualization Devices 15 Working end 16 Surgical site 18 Patient's Body 20 Working Space 22 Biological Tissue 100 Delivery Device 102 Handle 104 Shaft 106 lumens 108 lumens 110 Space-making elements 112 Distal end portion 200 Delivery Device 202 Handle 204 Shaft 206 Distal end portion 208 plane 210 plane 212 Actuator 214 Actuator 216 Actuator 218 Strain Relief Element 300 Delivery Device 302 Shaft 304 Longitudinal length 306 Proximal Zone 308 Intermediate Zone 310 Distal Zone 312 Over jacket 314 Structural Components 400 Handle 402 Endoscope 404 Therapeutic Devices 406 lumens 406A Connector 408 lumens 410 Actuator 502 Space-making elements 504 Shaft 506 Space-making elements 508 Distal End Face 510 Shaft 512 Space-making elements 514 Distal end face 516 Shaft 518 Space-making elements 520 Shaft 522 Space-making elements 524 Shaft 526 Space-making Elements 528 Shaft 530 Space-making elements 532 Extended Cylinder 534 Tip 600 Delivery Device 602 Expandable space-making element 604 Width 606 Shaft 608 Distal end portion 610 Circumferential recess 612 lumens 614 Device Lumens 616 Scope Lumens 618 Expandable Obturator 620 Distal tip part 650 Delivery Device 652 Expandable Space-Making Element 654 Distal Cap 668 Expandable Obturator 662A Inflation Lumen 662B Inflation Lumen 662C Internal expansion duct 662D Internal expansion duct 700 Delivery Device 702 Expandable space-making elements 704 Expandable space-making elements 706 Scope 708 Therapeutic Devices 800 Delivery Device 802 Shaft 804 Handle 806 Space-making elements 808 Distal end portion 900 Delivery Device 902 Space-making elements 904 Expandable Elements 906 Distal end portion 908 Shaft 910 Guidewire 912 lumens 914 Therapeutic Elements 1000 Delivery Device 1002 Guidewire 1004 Therapeutic Elements 1006 Movable and expandable elements 1100 Delivery Device 1102 Movable and expandable elements 1104 Shaft 1106 lumens 1200 Delivery Device 1202 Expandable expandable element 1204 Expandable expandable element 1206 Therapeutic Devices 1300 Shaft 1302 Therapeutic Device Lumen 1304 Visualization Device Lumen 1306 Inner shaft part 1308 Outer shaft part 1400 Shaft 1402 Therapeutic Device Lumen 1404 Visualization Device Lumen 1406 Inner shaft part 1408 Outer shaft part 1410 Central axis of inner shaft section 1412 Center axis of outer shaft portion 1500 Shaft 1502 Outer shaft part 1504 Maximum outer width 1506 Maximum outer width 1600 Delivery Device 1602 Endoscope 1604 Active Lock Brake Mechanism 1606 Spring 1608 Arm 1700 Delivery Device 1702 Handle 1704 Shaft 1706 Space-making elements 1708 Distal end portion 1709 Proximal part 1710 Cylindrical part 1712 diameter 1714 diameter 1716 Distal end face 1718 Transition 1720 Therapeutic Device Lumen 1722 Visualization Device Lumen 1723 Proximal fluid conduit 1724 Suction lumen 1725 Fluid Connector 1726 Suction Lumen 1728 Steering Lumen 1730 steering lumens 1732 Inflation lumen 1734 Inflation lumen 1736 Steering wire, pull wire 1738 Steering wire, pull wire 1740 Outer jacket 1742 Structural Components 1744 Hypotube 1746 Solid Part 1748 Gap 1750 Proximal part 1752 Distal part 1754 First Plane 1756 Second Plane 1758 Actuator 1764 Pull Ring 1766 Locking Actuator 1768 Proximal Port 1770 Proximal suction conduit 1772 Proximal suction conduit 1774 Suction Connector 1776 Suction Connector 1778 Proximal expansion conduit 1780 Proximal expansion conduit 1782 Expansion Connector 1784 Expansion Connector 1800 Expandable Space-Making Elements 1802 Proximal part 1804 Expandable Part 1806 Rib 1808 Secondary Welding 1850 Expandable Space-Making Element 1852 Proximal part 1854 Expandable section 1856 Rib 1858 Secondary Weld 1900 Expandable space-making elements 1902 Proximal part 1904 Expandable section 1906 Notch 1950 Expandable space-making element 1952 Proximal part 1954 Expandable section 1956 distal surface 1958 A plane perpendicular to the longitudinal axis of the shaft of the delivery device 1960 Longitudinal axis 2000 Expandable Space-Making Elements 2002 Expandable elements 2004 Expandable elements 2006 Expandable elements 2008 Conduit 2010 Conduit 2012 Conduit 2014 Inflation Lumen 2016 Inflation Lumen 2018 Inflation Lumen 2020 Structural Elements 2022 Structural Elements 2050 Expandable space-making element 2052 Expandable Element 2054 Expandable Element 2056 Expandable Element 2058 Expandable Element 2060 Folding structural elements 2062 Folding structural elements 2100 Expandable space-making element 2102 Expandable element 2104 Expandable element 2106 Foldable structural elements 2200 Delivery Device 2202 Rigid Space Creation Elements 2250 Structural Components 2252 Solid Part 2254 Gap 2256 Interlocking Features 2258 Interlocking Features 2300 Delivery Device 2302 Shaft 2304 Proximal first generally straight portion 2306 First Bend 2308 Second generally straight section 2310 Second opposite bend 2312 Third generally straight section 2314 Third Bend 2316 Distal fourth generally straight part

Claims

1. A delivery device configured to deliver a therapeutic device to a surgical site, comprising: a proximally disposed handle; an elongate shaft extending distally from the handle, the shaft including a generally longitudinal therapeutic device lumen configured to deliver a working end of a therapeutic device therethrough, a first portion of the shaft being steerable; a space-creating element disposed proximate a distal end portion of the shaft, the space-creating element configured to separate biological tissue and create or expand a working space, at least a portion of the space-creating element being reconfigurable between a retracted configuration and an expanded configuration; Including, the first portion of the shaft is steerable in a first plane; the handle includes a steering actuator configured to steer the first portion of the shaft in the first plane; A delivery device, wherein the first portion of the shaft is bidirectionally steerable in the first plane.

2. The delivery device of claim 1 , wherein the shaft further includes a generally longitudinal visualization device lumen configured to deliver a working end of a visualization device therethrough.

3. the handle includes a proximal port operably connected to the therapeutic device lumen and the visualization device lumen; The delivery device of claim 2 , wherein the proximal port is configured to receive the therapeutic device and the visualization device therethrough.

4. The delivery device of claim 1 , wherein the shaft further comprises a first generally longitudinal suction lumen configured to facilitate application of suction proximate the distal end portion of the shaft.

5. The delivery device of claim 4 , wherein the shaft further comprises a second generally longitudinal suction lumen configured to facilitate application of suction proximate the distal end portion of the shaft.

6. In the collapsed configuration, the space-creating element has a width approximately the same as a width of the shaft; The delivery device of claim 1 , wherein in the expanded configuration, the space-creating element has a width substantially greater than the width of the shaft.

7. The delivery device of claim 1 , wherein in the collapsed configuration, at least a portion of the space-making element is generally concentrically disposed within the distal end portion of the shaft.

8. The delivery device of claim 7 , wherein the distal end portion of the shaft includes a recess configured to receive at least a portion of the space-making element in the collapsed configuration.

9. The delivery device of claim 1 , wherein the space-creating element comprises an expandable space-creating element.

10. The delivery device of claim 9 , wherein the shaft includes a generally longitudinal first inflation lumen operably coupled to supply inflation fluid to the expandable space creating element.

11. The delivery device of claim 9 , wherein the expandable space-creating element is generally in the form of a right circular cylinder.

12. The delivery device of claim 9 , wherein the expandable space-creating element includes a plurality of generally circumferentially oriented ribs.

13. The delivery device of claim 9 , wherein the expandable space-creating element includes a plurality of generally longitudinally oriented ribs.

14. The delivery device of claim 9 , wherein the expandable space-creating element includes at least one orientation feature.

15. The delivery device of claim 14 , wherein the orientation feature comprises a notch.

16. The delivery device of claim 9 , wherein the expandable space-creating element includes a distal surface that is angled relative to a plane perpendicular to the longitudinal axis of the shaft.

17. The delivery device of claim 9 , wherein the expandable space-creating element comprises a plurality of longitudinally oriented expandable elements.

18. The delivery device of claim 17 , wherein at least one of the plurality of longitudinally oriented expandable elements is in the form of a generally circular tube.

19. The delivery device of claim 17 , wherein at least one of the plurality of longitudinally oriented expandable elements is in the form of a tube having a generally oval cross-section.

20. 20. The delivery device of claim 17, wherein the expandable space-creating elements include at least one collapsible structural element configured to promote spacing of the longitudinally oriented expandable elements.

21. The delivery device of claim 20 , wherein the foldable structural element comprises a foldable Nitinol frame.

22. The delivery device of claim 9 , wherein the expandable space-creating element includes at least one generally helical expandable element.

23. The delivery device of claim 22 , wherein the expandable space-creating element comprises two generally helical expandable elements in an alternating arrangement.

24. The delivery device of claim 1 , wherein the first portion of the shaft is deformable in a second plane, the second plane being generally perpendicular to the first plane.

25. The delivery device of claim 24 , wherein the first portion of the shaft is flexible in the second plane.

26. The delivery device of claim 24 , wherein the first portion of the shaft is steerable in the second plane.

27. 27. The delivery device of claim 26, wherein the first portion of the shaft is bidirectionally steerable in the second plane.

28. 2. The delivery device of claim 1, further comprising a first steering wire operably connecting the steering actuator and the first portion of the shaft to steer the first portion of the shaft in a first direction in the first plane.

29. 29. The delivery device of claim 28, further comprising a second steering wire operably connecting the steering actuator and the first portion of the shaft to steer the first portion of the shaft in a second direction in the first plane, the second direction being generally opposite to the first direction.

30. The delivery device of claim 1 , wherein the second portion of the shaft is flexible in a second plane, the second plane being generally perpendicular to the first plane.

31. The delivery device of claim 1 , wherein the handle further comprises at least one locking actuator configured to selectively lock the steering actuator.

32. The delivery device of claim 1 , wherein the second portion of the shaft is flexible in a first plane.

33. 33. The delivery device of claim 32, wherein the second portion of the shaft is flexible in a second plane, the second plane being generally perpendicular to the first plane.

34. 34. The delivery device of claim 33, wherein a flexibility of the second portion of the shaft in the first plane is greater than a flexibility of the second portion of the shaft in the second plane.

35. 34. The delivery device of claim 33, wherein a stiffness of the second portion of the shaft in the first plane is greater than a stiffness of the second portion of the shaft in the second plane.

36. 33. The delivery device of claim 32, wherein the second portion of the shaft is substantially uniformly flexible along a longitudinal length of the second portion of the shaft.

37. 33. The delivery device of claim 32, wherein shaft flexibility varies longitudinally over the longitudinal length of the second portion of the shaft.

38. 33. The delivery device of claim 32, wherein a flexibility of the first portion of the shaft is different than a flexibility of the second portion of the shaft.

39. The delivery device of claim 1 , wherein the shaft further comprises an outer jacket and a structural component radially disposed within the outer jacket.

40. 40. The delivery device of claim 39, wherein the structural component comprises a hypotube.

41. 41. The delivery device of claim 40, wherein the hypotube includes a plurality of solid portions and a plurality of gaps configured to promote desired flexibility characteristics of the shaft.

42. 42. The delivery device of claim 41, wherein the hypotube includes a first arrangement of the solid portions and the gaps in the first portion of the shaft and a second arrangement of the solid portions and the gaps in the second portion of the shaft, such that the first portion of the shaft and the second portion of the shaft have different flexibility characteristics.

43. The delivery device of claim 1 , further comprising an obturator positioned distally on the shaft.

44. 44. The delivery device of claim 43, wherein the obturator is expandable.

45. 44. The delivery device of claim 43, wherein the obturator is selectively removable from the delivery device.

46. The delivery device of claim 1 , wherein the therapeutic device includes at least one of an ablation device, a biopsy device, a pericardial lead, a needle for delivering a therapeutic agent, and a surgical tool.

47. The delivery device of claim 1, wherein the visualization device includes an endoscope.

48. A delivery device configured to deliver a therapeutic device to a surgical site, comprising: a proximally disposed handle; an elongate shaft extending distally from the handle, the shaft including a generally longitudinal therapeutic device lumen configured to deliver a working end of a therapeutic device therethrough, a first portion of the shaft being steerable; a space-creating element disposed proximate a distal end portion of the shaft, the space-creating element configured to separate biological tissue and create or expand a working space, at least a portion of the space-creating element being reconfigurable between a retracted configuration and an expanded configuration; Including, the space-creating element comprises an expandable space-creating element; A delivery device, wherein the expandable space-creating element includes at least one generally helical expandable element.

49. A delivery device as described in claim 48, wherein the shaft further includes a generally longitudinal visualization device lumen, the visualization device lumen configured to deliver a working end of a visualization device therethrough.

50. The handle includes a proximal port operably connected to the therapeutic device lumen and the visualization device lumen; 50. The delivery device of claim 49, wherein the proximal port is configured to receive the therapeutic device and the visualization device therethrough.

51. A delivery device as described in claim 48, wherein the shaft further includes a generally longitudinal first suction lumen configured to facilitate application of suction proximate the distal end portion of the shaft.

52. A delivery device as described in claim 51, wherein the shaft further includes a second generally longitudinal suction lumen configured to facilitate application of suction proximate the distal end portion of the shaft.

53. In the contracted configuration, the space-creating element has a width approximately the same as a width of the shaft; 49. The delivery device of claim 48, wherein in the expanded configuration, the space-creating element has a width substantially greater than the width of the shaft.

54. A delivery device as described in claim 48, wherein in the retracted configuration, at least a portion of the space creating element is generally concentrically arranged within the distal end portion of the shaft.

55. The delivery device of claim 54, wherein the distal end portion of the shaft includes a recess configured to receive at least a portion of the space creating element in the retracted configuration.

56. The delivery device of claim 48, wherein the shaft includes a generally longitudinal first inflation lumen operably connected to supply inflation fluid to the expandable space creating element.

57. The delivery device of claim 48, wherein the expandable space creating element is generally in the form of a right circular cylinder.

58. A delivery device as described in claim 48, wherein the expandable space creating element includes a plurality of generally circumferentially oriented ribs.

59. A delivery device as described in claim 48, wherein the expandable space creating element includes a plurality of generally longitudinally oriented ribs.

60. A delivery device as described in claim 48, wherein the expandable space creating element includes at least one orientation feature.

61. The delivery device of claim 60, wherein the orientation feature includes a notch.

62. A delivery device as described in claim 48, wherein the expandable space creating element includes a distal surface that is angled relative to a plane perpendicular to the longitudinal axis of the shaft.

63. The delivery device of claim 48, wherein the expandable space creating element includes a plurality of longitudinally oriented expandable elements.

64. A delivery device as described in claim 63, wherein at least one of the plurality of longitudinally oriented expandable elements is in the form of a generally circular tube.

65. A delivery device as described in claim 63, wherein at least one of the plurality of longitudinally oriented expandable elements is in the form of a tube having a generally elliptical cross-section.

66. The delivery device of claim 63, wherein the expandable space-creating element includes at least one foldable structural element configured to promote separation of the longitudinally oriented expandable elements.

67. The delivery device of claim 66, wherein the foldable structural element includes a foldable nitinol frame.

68. A delivery device as described in claim 48, wherein the expandable space creating element includes two generally spiral-shaped expandable elements in an alternating arrangement.

69. The first portion of the shaft is steerable in a first plane; 49. The delivery device of claim 48, wherein the handle includes a steering actuator configured to steer the first portion of the shaft in the first plane.

70. The delivery device of claim 69, wherein the first portion of the shaft is steerable in one direction in the first plane.

71. The delivery device of claim 69, wherein the first portion of the shaft is steerable in both directions in the first plane.

72. The delivery device of claim 69, wherein the first portion of the shaft is deformable in a second plane, the second plane being generally perpendicular to the first plane.

73. The delivery device of claim 72, wherein the first portion of the shaft is flexible in the second plane.

74. The delivery device of claim 72, wherein the first portion of the shaft is steerable in the second plane.

75. The delivery device of claim 74, wherein the first portion of the shaft is steerable bidirectionally in the first plane and bidirectionally in the second plane.

76. The delivery device of claim 69, further comprising a first steering wire operably connecting the steering actuator and the first portion of the shaft to steer the first portion of the shaft in a first direction in the first plane.

77. The delivery device of claim 76, further comprising a second steering wire operably connecting the steering actuator and the first portion of the shaft to steer the first portion of the shaft in a second direction in the first plane, the second direction being generally opposite to the first direction.

78. The delivery device of claim 69, wherein the second portion of the shaft is flexible in a second plane, the second plane being generally perpendicular to the first plane.

79. The delivery device of claim 69, wherein the handle further includes at least one locking actuator configured to selectively lock the steering actuator.

80. The delivery device of claim 48, wherein the second portion of the shaft is flexible in a first plane.

81. The delivery device of claim 80, wherein the second portion of the shaft is flexible in a second plane, the second plane being generally perpendicular to the first plane.

82. A delivery device as described in claim 81, wherein the flexibility of the second portion of the shaft in the first plane is greater than the flexibility of the second portion of the shaft in the second plane.

83. A delivery device as described in claim 81, wherein the stiffness of the second portion of the shaft in the first plane is greater than the stiffness of the second portion of the shaft in the second plane.

84. A delivery device as described in claim 80, wherein the second portion of the shaft is substantially uniformly flexible along the longitudinal length of the second portion of the shaft.

85. A delivery device as described in claim 80, wherein shaft flexibility varies longitudinally across the longitudinal length of the second portion of the shaft.

86. The delivery device of claim 80, wherein the flexibility of the first portion of the shaft is different from the flexibility of the second portion of the shaft.

87. The delivery device of claim 48, wherein the shaft further includes an outer jacket and a structural component radially disposed within the outer jacket.

88. The delivery device of claim 87, wherein the structural component includes a hypotube.

89. The delivery device of claim 88, wherein the hypotube includes a plurality of solid portions and a plurality of gaps configured to promote desired flexibility characteristics of the shaft.

90. The delivery device of claim 89, wherein the hypotube includes a first arrangement of the solid portions and the gaps in the first portion of the shaft and a second arrangement of the solid portions and the gaps in the second portion of the shaft, such that the first portion of the shaft and the second portion of the shaft have different flexibility characteristics.

91. The delivery device of claim 48, further comprising an obturator positioned distally on the shaft.

92. The delivery device of claim 91, wherein the obturator is inflatable.

93. The delivery device of claim 91, wherein the obturator is selectively removable from the delivery device.

94. The delivery device of claim 48, wherein the therapeutic device includes at least one of an ablation device, a biopsy device, a pericardial lead, a needle for delivering a therapeutic agent, and a surgical tool.

95. The delivery device of claim 48, wherein the visualization device includes an endoscope.

96. A delivery device configured to deliver a therapeutic device to a surgical site, comprising: a proximally disposed handle; an elongate shaft extending distally from the handle, the shaft including a generally longitudinal therapeutic device lumen configured to deliver a working end of a therapeutic device therethrough, a first portion of the shaft being steerable; a space-creating element disposed proximate a distal end portion of the shaft, the space-creating element configured to separate biological tissue and create or expand a working space, at least a portion of the space-creating element being reconfigurable between a retracted configuration and an expanded configuration; Including, the second portion of the shaft is flexible in a first plane; A delivery device, wherein the flexibility of the first portion of the shaft is different than the flexibility of the second portion of the shaft.

97. A delivery device as described in claim 96, wherein the shaft further includes a generally longitudinal visualization device lumen, the visualization device lumen configured to deliver a working end of a visualization device therethrough.

98. The handle includes a proximal port operably connected to the therapeutic device lumen and the visualization device lumen; 98. The delivery device of claim 97, wherein the proximal port is configured to receive the therapeutic device and the visualization device therethrough.

99. A delivery device as described in claim 96, wherein the shaft further includes a generally longitudinal first suction lumen configured to facilitate application of suction proximate the distal end portion of the shaft.

100. A delivery device as described in claim 99, wherein the shaft further includes a second generally longitudinal suction lumen configured to facilitate application of suction proximate the distal end portion of the shaft.

101. In the collapsed configuration, the space-creating element has a width approximately the same as a width of the shaft; 97. The delivery device of claim 96, wherein in the expanded configuration, the space-creating element has a width substantially greater than the width of the shaft.

102. A delivery device as described in claim 96, wherein in the retracted configuration, at least a portion of the space creating element is generally concentrically arranged within the distal end portion of the shaft.

103. A delivery device as described in claim 102, wherein the distal end portion of the shaft includes a recess configured to receive at least a portion of the space creating element in the retracted configuration.

104. A delivery device as described in claim 96, wherein the space creating element includes an expandable space creating element.

105. A delivery device as described in claim 104, wherein the shaft includes a generally longitudinal first inflation lumen operably connected to supply inflation fluid to the expandable space creating element.

106. A delivery device as described in claim 104, wherein the expandable space creating element is generally in the form of a right circular cylinder.

107. A delivery device as described in claim 104, wherein the expandable space creating element includes a plurality of generally circumferentially oriented ribs.

108. A delivery device as described in claim 104, wherein the expandable space creating element includes a plurality of generally longitudinally oriented ribs.

109. A delivery device as described in claim 104, wherein the expandable space creating element includes at least one orientation feature.

110. The delivery device of claim 109, wherein the orientation feature includes a notch.

111. A delivery device as described in claim 104, wherein the expandable space creating element includes a distal surface that is angled relative to a plane perpendicular to the longitudinal axis of the shaft.

112. A delivery device as described in claim 104, wherein the expandable space creating element includes a plurality of longitudinally oriented expandable elements.

113. A delivery device as described in claim 112, wherein at least one of the plurality of longitudinally oriented expandable elements is in the form of a generally circular tube.

114. A delivery device as described in claim 112, wherein at least one of the plurality of longitudinally oriented expandable elements is in the form of a tube having a generally elliptical cross-section.

115. A delivery device as described in claim 112, wherein the expandable space-creating element includes at least one foldable structural element configured to promote separation of the longitudinally oriented expandable elements.

116. A delivery device as described in claim 115, wherein the foldable structural element includes a foldable nitinol frame.

117. A delivery device as described in claim 104, wherein the expandable space creating element includes at least one generally spiral-shaped expandable element.

118. A delivery device as described in claim 117, wherein the expandable space creating element includes two generally spiral-shaped expandable elements in an alternating arrangement.

119. The first portion of the shaft is steerable in a first plane; 97. The delivery device of claim 96, wherein the handle includes a steering actuator configured to steer the first portion of the shaft in the first plane.

120. A delivery device as described in claim 119, wherein the first portion of the shaft is steerable in one direction in the first plane.

121. A delivery device as described in claim 119, wherein the first portion of the shaft is steerable in both directions in the first plane.

122. A delivery device as described in claim 119, wherein the first portion of the shaft is deformable in a second plane, the second plane being generally perpendicular to the first plane.

123. The delivery device of claim 122, wherein the first portion of the shaft is flexible in the second plane.

124. A delivery device as described in claim 122, wherein the first portion of the shaft is steerable in the second plane.

125. A delivery device as described in claim 124, wherein the first portion of the shaft is steerable bidirectionally in the first plane and bidirectionally in the second plane.

126. The delivery device of claim 119, further comprising a first steering wire operably connecting the steering actuator and the first portion of the shaft to steer the first portion of the shaft in a first direction in the first plane.

127. The delivery device of claim 126, further comprising a second steering wire operably connecting the steering actuator and the first portion of the shaft to steer the first portion of the shaft in a second direction in the first plane, the second direction being generally opposite to the first direction.

128. The delivery device of claim 119, wherein the second portion of the shaft is flexible in a second plane, the second plane being generally perpendicular to the first plane.

129. A delivery device as described in claim 119, wherein the handle further includes at least one locking actuator configured to selectively lock the steering actuator.

130. The delivery device of claim 96, wherein the second portion of the shaft is flexible in a second plane, the second plane being generally perpendicular to the first plane.

131. A delivery device as described in claim 130, wherein the flexibility of the second portion of the shaft in the first plane is greater than the flexibility of the second portion of the shaft in the second plane.

132. A delivery device as described in claim 130, wherein the stiffness of the second portion of the shaft in the first plane is greater than the stiffness of the second portion of the shaft in the second plane.

133. A delivery device as described in claim 96, wherein the second portion of the shaft is substantially uniformly flexible along the longitudinal length of the second portion of the shaft.

134. A delivery device as described in claim 96, wherein shaft flexibility varies longitudinally across the longitudinal length of the second portion of the shaft.

135. A delivery device as described in claim 96, wherein the shaft further includes an outer jacket and a structural component radially disposed within the outer jacket.

136. The delivery device of claim 135, wherein the structural component includes a hypotube.

137. A delivery device as described in claim 136, wherein the hypotube includes a plurality of solid portions and a plurality of gaps configured to promote desired flexibility characteristics of the shaft.

138. The delivery device of claim 137, wherein the hypotube includes a first arrangement of the solid portions and the gaps in the first portion of the shaft and a second arrangement of the solid portions and the gaps in the second portion of the shaft, such that the first portion of the shaft and the second portion of the shaft have different flexibility characteristics.

139. A delivery device as described in claim 96, further comprising an obturator positioned distally on the shaft.

140. The delivery device of claim 139, wherein the obturator is inflatable.

141. A delivery device as described in claim 139, wherein the obturator is selectively removable from the delivery device.

142. The delivery device of claim 96, wherein the therapeutic device includes at least one of an ablation device, a biopsy device, a pericardial lead, a needle for delivering a therapeutic agent, and a surgical tool.

143. The delivery device of claim 96, wherein the visualization device includes an endoscope.

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