Patent Description:
Known medical devices are configured to facilitate a medical procedure, and help healthcare providers diagnose and/or treat medical conditions.

Document <CIT> discloses an apparatus for sealing a puncture through a vessel wall including a positioning assembly, a sheath releasably engaged with the positioning assembly, and a support member axially advanceable through the sheath. The positioning assembly includes a positioning element positioned at a distal portion of the positioning assembly and a sealant disposed at a distal portion of the positioning assembly. The sheath guides the sealant and positioning assembly to the puncture in the vessel wall.

Document <CIT> discloses systems and methods to deploy an electrode from a catheter assembly. The systems and methods provide a catheter handle having a trigger lever adapted to carry an actuator rod. The actuator rod is adapted to cause movement of the electrode between a retracted position and an extended position. A pinion is carried by the trigger lever for engagement with a rack carried by the actuator rod. Compression of the trigger lever moves the rack along the actuator rod between a first position corresponding to the electrodes being in the retracted position and a second position corresponding to either the primed electrode firing position or the electrodes being in an extended position.

Document <CIT> discloses a system for delivery and deployment of an occluder including a handle, an actuating mechanism with a motion amplifier and a sheath positioning mechanism within the handle. A driveshaft of the actuating mechanism extends through the handle, the sheath positioning mechanism, and an attached sheath so as to couple with an occluder deployed via the driveshaft within a body lumen in a patient.

Document <CIT> discloses a soft tissue core biopsy instrument comprising a proximal outer barrel member and a distal inner barrel member which is slidably received within the outer barrel member. A cannula driver is slidably received within the distal inner barrel member and has a distally extending cannula fixed thereto. A stylet extends distally from a stylet hub with a stylet hub being removably attached to the proximal outer barrel member. A spring is positioned within the inner barrel member between a proximal wall thereof and a proximal wall of the cannula driver for biasing the cannula driver forwardly and a latching mechanism for latching the cannula driver in a proximally retracted position against the action of spring is also provided. A trigger for unlatching the latching mechanism may be actuated to allow the spring to quickly, return to its forwardly biased position, shooting or forcing the cannula driver to a distally extended position, projecting the cannula over said stylet.

Document <CIT> appears to disclose a multi-function instrument platform is that can be variably configured by clinicians to treat occlusions. The Functionally Integrable Catheter System refers to a system of "functional units" that can be configured together to operate synergistically, and includes at least four main "functional units" including: (a) a Functionally Integrable Catheter System support catheter (<NUM>), (b) a Functionally Integrable Catheter System dilator (<NUM>), (c) a Functionally Integrable Catheter System PTA catheter (<NUM>), and (d) a Functionally Integrable Catheter System lock-grip handle (<NUM>). Each "functional unit" may be provided in a pre-assembled form by the manufacturer, intended to be configured into variable combinations by the clinical worker.

Document <CIT> discloses methods and devices for puncturing tissue, comprising a puncture device for puncturing tissue and a supporting member for supporting the puncture device. The puncture device is capable of being insertable within the supporting member and being selectively usable in co-operation therewith during a portion of a procedure for puncturing tissue and wherein the puncture device is usable independently therefrom during another portion of the procedure. The puncture device comprises visual or tactile markers for determining the relative positioning between puncture device and supporting member.

Document <CIT> discloses apparatus and systems that incorporate coupling mechanisms to enable coupling of two mating member such as medical devices such as introducers, sheaths, dilators. More specifically, the disclosure relates to releasable coupling mechanisms, to allow for releasable coupling of two medical devices such as a dilator and a sheath so the devices can be maneuvered and/or manipulated together for example during a part of a medical procedure.

It will be appreciated that there exists a need to mitigate (at least in part) at least one problem associated with the existing (known) sheath assemblies (also called the existing technology). After much study of, and experimentation with, the existing (known) sheath assemblies, an understanding (at least in part) of the problem and its solution have been identified (at least in part) and are articulated (at least in part) as follows:.

Transseptal puncture of the fossa ovalis (of the heart of a patient) may require a puncture device to first be positioned by a guiding device (such as a sheath/dilator combination). The sheath/dilator combination is configured to push against, and tent, the septum to provide visual confirmation through or via a medical imaging system. The issue lies in controlling the pressure that may be applied onto the septum. Insufficient force may not result in visible tenting, while excessive force may increase the risk of the sheath/dilator springing forward into the left atrium after puncture.

<FIG> and <FIG> depicts a side perspective view of an embodiment of a known elongated sheath assembly, and an elongated dilator assembly for use with, or configured to be used with (to be inserted, at least in part) into the known elongated sheath assembly.

<FIG> and <FIG> depicts a side perspective view (<FIG>) and a side view (<FIG>) of embodiments of the known elongated dilator assembly of <FIG> inserted into the elongated sheath assembly of <FIG>.

Referring to the embodiment as depicted in <FIG>, the known sheath assembly includes a first end section defining an entrance portal. A second end section is spaced apart from the first end section. The second end section defines an exit portal. A stationary shaft extends between the first end section and the second end section. The stationary shaft defines a shaft lumen extending along a longitudinal length of the sheath assembly. The stationary shaft has a fixed length (a predetermined length). The entrance portal and the exit portal are in fluid communication with each other via the shaft lumen. A sheath-handle assembly is positioned at the first end section. A sheath hub is positioned at the first end section. Preferably, the sheath hub is positioned in the interior of the sheath-handle assembly.

Referring to the embodiment as depicted in <FIG>, the elongated dilator assembly includes a dilator handle at one end section (of the elongated dilator assembly), and a dilator distal tip positioned at the opposite end section (of the elongated dilator assembly). A dilator hub is positioned at the dilator handle, and faces or is oriented toward the dilator distal tip. An elongated dilator shaft extends between the dilator hub and the dilator distal tip. The dilator assembly has a fixed length (a predetermined length).

Referring to the embodiment as depicted in <FIG>, the sheath assembly is mated with the elongated dilator assembly. The sheath assembly is configured to receive (slidably receive) the elongated dilator assembly within the shaft lumen of the stationary shaft (along the longitudinal length of the sheath assembly). Once the sheath assembly, in use, fully receives (is fully mated with) the elongated dilator assembly within the shaft lumen, the front section of the elongated dilator assembly extends outwardly from the front section (of the sheath assembly) to expose (display) a fixed exposed dilator shaft portion having a fixed length (a predetermined shaft length, which is a fixed portion of the dilator shaft).

Referring to the embodiment as depicted in <FIG>, the problem with this arrangement is that for the case where the reach of the elongated dilator assembly is too long or too short resulting in excessive or insufficient tenting of the septum (located in the right atrium of the heart of the patient), the surgeon may need to adjust (the orientation of and/or the alignment of) the curve (shape) of the elongated dilator assembly either through manual manipulation and/or by utilizing a steering mechanism (known and not depicted), thereby wasting or increasing valuable or critical surgical time. The dilator and the known sheath may be typically long enough for the procedure. The reach of the dilator may be controlled by how it is curved in the right atrium. One solution may be to adjust the bend (curve) of the dilator; however, this may require (A) pulling the dilator out from the known sheath and manually bending the dilator (if the dilator is shapeable), and/or (B) using a steerable known sheath (known and not depicted) that the surgeon (operator) may then control the curve of the dilator. Both methods may be imprecise and also may be dependent on the surgeon's experience and comfort with the procedure. It may be desirable to provide a workflow that starts with a long reach and tenting (over-tenting) the septum, then withdrawing the dilator to an appropriate degree (or amount) of tent formed in a portion of the septum; it will be appreciated that this desirable methodology may be more intuitive than changing the curve of the dilator.

Referring to the embodiment as depicted in <FIG>, it may be desirable to avoid the process of adjusting the curve of the elongated dilator assembly and thereby avoid wasting valuable or critical surgical time.

Referring to the embodiment as depicted in <FIG>, it may be desirable to provide an arrangement in which the additional length of the elongated dilator assembly, which becomes exposed during a procedure, in which the length thereof may be adjusted by the operator while the sheath assembly is positioned, thereby saving valuable or critical surgical time (as a result of).

Referring to the embodiment as depicted in <FIG>, it may be desirable to provide an arrangement in which the elongated dilator assembly may be selectively extended (moved further out from) or retracted into (pulled into) (the output of) a sheath assembly, while the elongated dilator assembly remains mated to the sheath assembly during a procedure, so that the elongated dilator assembly may become selectively moved (and exposed at least in part) from the end portion of the sheath assembly (during the procedure). Selectively moved means that the elongated dilator assembly is movable in response to receiving an application of a movement force; the elongated dilator assembly does not move of its own accord without application of a movement force.

To mitigate, at least in part, at least one problem associated with the existing technology, there is provided (in accordance with a major aspect) a kit. The kit includes and is not limited to (comprises) a first medical assembly. A second medical assembly is configured to receive, at least in part, the first medical assembly. A receiver device is configured to be mounted, at least in part, to the second medical assembly. The receiver device is also configured to receive the first medical assembly. A receiver mover is configured to be operatively connected to the receiver device in such a way that the receiver mover selectively moves the receiver device along a predetermined distance.

To mitigate, at least in part, at least one problem associated with the existing technology, there is provided (in accordance with a major aspect) a kit. The kit includes, and is not limited to (comprises) a synergistic combination of elements. The kit includes, for instance, an elongated dilator assembly and an elongated sheath assembly configured to receive, at least in part, the elongated dilator assembly. The kit also includes a dilator-receiver device configured to be (having a structure configured to be) mounted to, at least in part, the elongated sheath assembly. The kit also includes a dilator-receiver mover configured to be operatively connected to, at least in part, the dilator-receiver device. Preferably, the dilator-receiver mover is configured to selectively move the dilator-receiver device along a predetermined distance. In accordance with a preferred embodiment, the dilator-receiver mover is configured to be mounted, at least in part, to the elongated sheath assembly.

To mitigate, at least in part, at least one problem associated with the existing technology, there is provided (in accordance with a major aspect) an apparatus. The apparatus is for use with (configured to be used with) an elongated dilator assembly. The apparatus includes and is not limited to (comprises) an elongated sheath assembly configured to receive, at least in part, the elongated dilator assembly. A dilator-receiver device is configured to be mounted, at least in part, to the elongated sheath assembly. A dilator-receiver mover is operatively connected to the dilator-receiver device. Preferably, the dilator-receiver mover is configured to selectively move the dilator-receiver device along a predetermined distance.

To mitigate, at least in part, at least one problem associated with the existing technology, there is provided (in accordance with a major aspect) an apparatus. The apparatus is usable with (is for) an elongated sheath assembly. The elongated sheath assembly is configured to receive, at least in part, an elongated dilator assembly. The apparatus includes and is not limited to (comprises) a synergistic combination of a dilator-receiver device and a dilator-receiver mover. The dilator-receiver device is configured to be mounted, at least in part, to the elongated sheath assembly. The dilator-receiver mover is configured to be operatively connected, at least in part, to the dilator-receiver device. In accordance with a preferred embodiment, the dilator-receiver mover is configured to be mounted, at least in part, to the elongated sheath assembly. Preferably, the dilator-receiver mover is configured to selectively move the dilator-receiver device along a predetermined distance.

To mitigate, at least in part, at least one problem associated with the existing technology, there is provided (in accordance with a major aspect) a method. The method is for operating an elongated sheath assembly configured to receive, at least in part, an elongated dilator assembly. The method includes and is not limited to (comprises) selectively receiving and supporting, at least in part, the elongated dilator assembly via a dilator-receiver device mounted to, at least in part, the elongated sheath assembly. The method also includes selectively moving, at least in part, the dilator-receiver device and the elongated dilator assembly along a predetermined distance, via a dilator-receiver mover operatively connected to the dilator-receiver device, after the elongated dilator assembly is received, at least in part, by the dilator-receiver device. In accordance with a preferred embodiment, the dilator-receiver mover is configured to be mounted, at least in part, to the elongated sheath assembly. Preferably, the dilator-receiver mover is configured to selectively move the dilator-receiver device along the predetermined distance.

Other aspects are identified in the claims. Other aspects and features of the non-limiting embodiments may now become apparent to those skilled in the art upon review of the following detailed description of the non-limiting embodiments with the accompanying drawings. This Summary is provided to introduce concepts in simplified form that are further described below in the Detailed Description. This Summary is not intended to identify potentially key features or possible essential features of the disclosed subject matter, and is not intended to describe each disclosed embodiment or every implementation of the disclosed subject matter. Many other novel advantages, features, and relationships will become apparent as this description proceeds. The figures and the description that follow more particularly exemplify illustrative embodiments.

The non-limiting embodiments may be more fully appreciated by reference to the following detailed description of the non-limiting embodiments when taken in conjunction with the accompanying drawings, in which:.

The drawings are not necessarily to scale and may be illustrated by phantom lines, diagrammatic representations and fragmentary views. In certain instances, details unnecessary for an understanding of the embodiments (and/or details that render other details difficult to perceive) may have been omitted. Corresponding reference characters indicate corresponding components throughout the several figures of the drawings. Elements in the several figures are illustrated for simplicity and clarity and have not been drawn to scale. The dimensions of some of the elements in the figures may be emphasized relative to other elements for facilitating an understanding of the various disclosed embodiments. In addition, common, and well-understood, elements that are useful in commercially feasible embodiments are often not depicted to provide a less obstructed view of the embodiments of the present disclosure.

The following detailed description is merely exemplary and is not intended to limit the described embodiments or the application and uses of the described embodiments. As used, the word "exemplary" or "illustrative" means "serving as an example, instance, or illustration. " Any implementation described as "exemplary" or "illustrative" is not necessarily to be construed as preferred or advantageous over other implementations. All of the implementations described below are exemplary implementations provided to enable persons skilled in the art to make or use the embodiments of the disclosure and are not intended to limit the scope of the disclosure. The scope of the disclosure is defined by the claims. For the description, the terms "upper," "lower," "left," "rear," "right," "front," "vertical," "horizontal," and derivatives thereof shall relate to the examples as oriented in the drawings. There is no intention to be bound by any expressed or implied theory in the preceding Technical Field, Background, Summary or the following detailed description. It is also to be understood that the devices and processes illustrated in the attached drawings, and described in the following specification, are exemplary embodiments (examples), aspects and/or concepts defined in the appended claims. Hence, dimensions and other physical characteristics relating to the embodiments disclosed are not to be considered as limiting, unless the claims expressly state otherwise. It is understood that the phrase "at least one" is equivalent to "a". The aspects (examples, alterations, modifications, options, variations, embodiments and/or any equivalent thereof) are described regarding the drawings. It should be understood that the disclosure is limited to the subject matter provided by the claims, and that the disclosure is not limited to the particular aspects depicted and described. It will be appreciated that the scope of the meaning of a device configured to be coupled to an item (that is, to be connected to, to interact with the item, etc.) is to be interpreted as the device being configured to be coupled to the item, either directly or indirectly. Therefore, "configured to" may include the meaning "either directly or indirectly" unless specifically stated otherwise.

<FIG> depict a side perspective view (<FIG>) and a front view (<FIG>) of embodiments of a dilator-receiver device <NUM> and a dilator-receiver mover <NUM> mounted to an elongated sheath assembly <NUM>.

<FIG>, <FIG>, <FIG> and <FIG> depict cross-sectional views of the dilator-receiver device <NUM> and the dilator-receiver mover <NUM> mounted to the elongated sheath assembly <NUM> of <FIG>. An elongated dilator assembly <NUM> is for use with, or configured to be used with (to be inserted, at least in part, into) the elongated sheath assembly <NUM>. The cross-sectional views of <FIG>, <FIG>, <FIG> and <FIG> are taken along the cross-sectional line A-A of <FIG>.

Referring to the embodiments as depicted in <FIG> and <FIG>, there is depicted a kit. The kit includes an elongated dilator assembly <NUM> and an elongated sheath assembly <NUM> configured to receive, at least in part, the elongated dilator assembly <NUM>. A dilator-receiver device <NUM> is configured to be mounted (installed), at least in part, to the elongated sheath assembly <NUM>. The dilator-receiver device <NUM> includes (preferably) a moveable shaft <NUM> configured to be mounted, at least in part, to the elongated sheath assembly <NUM>. The dilator-receiver device <NUM> has (preferably) a receiver structure configured to be mounted, at least in part, to the elongated sheath assembly <NUM>. A dilator-receiver mover <NUM> is configured to be operatively connected (directly or indirectly, couple) to the dilator-receiver device <NUM>; this is done in such a way that the dilator-receiver mover <NUM> selectively moves the dilator-receiver device <NUM> along a predetermined distance <NUM>.

Referring to the embodiments as depicted in <FIG> and <FIG>, the elongated dilator assembly <NUM> may include any type of sheath device, such as that type used for transseptal puncturing. The elongated dilator assembly <NUM> may be of a different size, shape and/or material. The elongated dilator assembly <NUM> may be configured to be steerable or fixed. The elongated sheath assembly <NUM> may be any type of dilator compatible with the elongated dilator assembly <NUM>; the elongated sheath assembly <NUM> is configured to mate with the elongated dilator assembly <NUM>, preferably at a proximal hub to prevent unwanted movement of the elongated sheath assembly <NUM>.

Referring to the embodiments as depicted in <FIG> and <FIG>, the dilator-receiver mover <NUM> is configured (preferably) to selectively move the dilator-receiver device <NUM> from a first predetermined distance <NUM> (as depicted in <FIG>) to a second predetermined distance <NUM> (as depicted in <FIG>); this is done in such a way that the elongated dilator assembly <NUM> is also moveable from the first predetermined distance <NUM> (as depicted in <FIG>) to the second predetermined distance <NUM>. Preferably, this is done in such a way that the dilator-receiver mover <NUM> and the elongated dilator assembly <NUM> are moveable between the first predetermined distance <NUM> (as depicted in <FIG>) and the second predetermined distance <NUM> (as depicted in <FIG>); that is, while a portion (such as a dilator hub <NUM>) of the elongated dilator assembly <NUM> and a portion (such as a sheath hub <NUM>) of the elongated sheath assembly <NUM> remain in contact (in an abutment relationship or contact arrangement) with each other.

Referring to the embodiments as depicted in <FIG> and <FIG>, in accordance with a preferred embodiment, the dilator-receiver mover <NUM> is configured (preferably) to be mounted (installed) to the elongated sheath assembly <NUM>; this is done (preferably) in such a way that the dilator-receiver mover <NUM> selectively moves the dilator-receiver device <NUM> along a predetermined distance <NUM> (as depicted in <FIG>). Referring back to <FIG> and <FIG>, the dilator-receiver mover <NUM> may include a position-control device, a translation assembly, a gear assembly, and/or any equivalent thereof. For instance, the gear assembly (as depicted in <FIG> or <FIG>) may include (and is not limited to) a synergistic combination of an input gear <NUM> and an output gear <NUM>, etc. and/or any equivalent thereof. The input gear <NUM> is moveable (rotatable, reciprocatable) along a rotation direction <NUM>. The output gear <NUM> is moveable along a reciprocation path <NUM> (preferably, a linear reciprocation path). The input gear <NUM> and the output gear <NUM> are configured to mesh with each other. The input gear <NUM> is operatively mounted to the elongated sheath assembly <NUM> (preferably mounted to the sheath-handle assembly <NUM> (or a housing) of the elongated sheath assembly <NUM>). The output gear <NUM> is fixedly mounted to an outer surface of the moveable shaft <NUM> (or generally to the dilator-receiver device <NUM>). Generally, the dilator-receiver mover <NUM> has a mover structure (such as the gear assembly, etc.) configured to be mounted (installed) to (a section or portion of) the elongated sheath assembly <NUM>.

Referring to the embodiment as depicted in <FIG>, there is depicted a kit. The kit includes a first medical assembly <NUM>. The first medical assembly <NUM> includes and is not limited to an elongated dilator assembly <NUM>, a catheter, etc. and/or any equivalent thereof. The first medical assembly <NUM> and/or the elongated dilator assembly <NUM> is configured to be inserted into a confined space defined by a living body (a patient). The kit also includes a second medical assembly <NUM> configured to receive, at least in part, the first medical assembly <NUM>. The second medical assembly <NUM> may include and is not limited to an elongated sheath assembly <NUM> and/or any equivalent thereof. The second medical assembly <NUM> is (preferably) configured to guide the insertion of the first medical assembly <NUM> into the confined space defined by the patient. The first medical assembly <NUM> and the second medical assembly <NUM> are (preferably) impermeable by a bodily fluid of the patient. The first medical assembly <NUM> and the second medical assembly <NUM> each includes (in accordance with a preferred embodiment) bio-compatible materials properties suitable for sufficient performance properties (dielectric strength, thermal performance, insulation and corrosion, water and heat resistance) for safe performance to comply with industrial and regulatory safety standards (or compatible for medical usage). Reference is made to the following publication for consideration in the selection of a suitable material: <NPL>]. The kit also includes a receiver device <NUM> configured to be mounted, at least in part, to the second medical assembly <NUM>. The receiver device <NUM> is configured to receive the first medical assembly <NUM>. The receiver device <NUM> may include, and is not limited, to a dilator-receiver device <NUM> and anything equivalent thereof. The kit also includes a receiver mover <NUM> configured to be operatively connected to the receiver device <NUM>; this is done in such a way that the receiver mover <NUM> selectively moves the receiver device <NUM> along a predetermined distance <NUM>. The receiver mover <NUM> includes, and is not limited to, a dilator-receiver mover <NUM> and anything equivalent thereof.

Referring to the embodiments as depicted in <FIG> and <FIG>, there is depicted an apparatus for use with (configured to be installed to) an elongated dilator assembly <NUM>. The apparatus includes an elongated sheath assembly <NUM> configured to receive, at least in part, the elongated dilator assembly <NUM>. A dilator-receiver device <NUM> is configured to be mounted, at least in part, to the elongated sheath assembly <NUM>. A dilator-receiver mover <NUM> is operatively connected to the dilator-receiver device <NUM>. Preferably, the dilator-receiver mover <NUM> is configured to selectively move the dilator-receiver device <NUM> along a predetermined distance <NUM>.

Referring to the embodiments as depicted in <FIG> and <FIG>, there is depicted an apparatus for (configured to be installed to) an elongated sheath assembly <NUM> configured to receive, at least in part, an elongated dilator assembly <NUM>. The apparatus includes a dilator-receiver device <NUM>, such as a moveable shaft <NUM> and/or any equivalent thereof. The dilator-receiver device <NUM> is mounted to (configured to be installed to, installed to, installed into, at least in part) the elongated sheath assembly <NUM>. The dilator-receiver device <NUM> includes any suitable type of mount structure configured to be mounted, at least in part, to the elongated sheath assembly <NUM>. A dilator-receiver mover <NUM> is configured to be operatively connected (directly or indirectly, coupled) to the dilator-receiver device <NUM>. Preferably, the dilator-receiver mover <NUM> is configured to selectively move the dilator-receiver device <NUM> along a predetermined distance <NUM>.

Referring to the embodiments as depicted in <FIG> and <FIG>, the dilator-receiver mover <NUM> has a mounting structure configured to be mounted (installed) to the elongated sheath assembly <NUM>.

Referring to the embodiments as depicted in <FIG> and <FIG>, the dilator-receiver device <NUM> is configured to selectively receive and support, at least in part, the elongated dilator assembly <NUM>; this is done, preferably, after the elongated sheath assembly <NUM>, in use, receives, at least in part, the elongated dilator assembly <NUM>.

Referring to the embodiments as depicted in <FIG> and <FIG>, the dilator-receiver mover <NUM> is configured to operatively connect (or has a structure configured to connect or couple), either directly or indirectly, to the dilator-receiver device <NUM>.

Referring to the embodiments as depicted in <FIG> and <FIG>, the dilator-receiver mover <NUM> is configured to selectively move (translate, linearly translate), at least in part, the dilator-receiver device <NUM> and the elongated dilator assembly <NUM> after the elongated dilator assembly <NUM> is received, at least in part, by the dilator-receiver device <NUM> (as depicted in <FIG> and <FIG>).

Referring to the embodiments as depicted in <FIG> and <FIG>, the elongated sheath assembly <NUM> is configured to (slidably) receive, at least in part, the elongated dilator assembly <NUM> along, at least in part, a length of the elongated sheath assembly <NUM>.

Referring to the embodiments as depicted in <FIG> and <FIG>, the elongated sheath assembly <NUM> defines an exit portal <NUM>. The elongated sheath assembly <NUM> includes a sheath hub <NUM> configured to be received, at least in part, into the hub cavity <NUM>. The sheath hub <NUM> is also configured to be moveable, at least in part, along the hub cavity <NUM>. The sheath hub <NUM> is also configured to abut, at least in part, a dilator hub <NUM> of the elongated dilator assembly <NUM>; this is done, preferably, after the dilator hub <NUM> is positioned to abut, at least in part, the sheath hub <NUM> (preferably, after the sheath hub <NUM> is received, at least in part, into the hub cavity <NUM>).

Referring to the embodiments as depicted in <FIG> and <FIG>, the elongated sheath assembly <NUM> includes a first end section <NUM> (an entrance end) defining an entrance portal <NUM> leading to a hub cavity <NUM>. A second end section <NUM> (an exit end) defines an exit portal <NUM>. An elongated axis <NUM> extends axially between the first end section <NUM> and the second end section <NUM>. A sheath hub <NUM> is configured to be received, at least in part, into the entrance portal <NUM> and the hub cavity <NUM> of the first end section <NUM>. The sheath hub <NUM> is also configured to be moveable, at least in part, along the hub cavity <NUM> (along the elongated axis <NUM>) after the sheath hub <NUM> is received, at least in part, in the hub cavity <NUM>. The sheath hub <NUM> is also configured to abut, at least in part, a dilator hub <NUM> of the elongated dilator assembly <NUM>; this is done, preferably, after the dilator hub <NUM> is positioned to abut, at least in part, the sheath hub <NUM> (preferably, after the sheath hub <NUM> is received, at least in part, into the hub cavity <NUM>).

Referring to the embodiments as depicted in <FIG> and <FIG>, the dilator-receiver mover <NUM> is positioned proximate to the sheath hub <NUM> of the elongated sheath assembly <NUM>. The dilator-receiver mover <NUM> is configured to selectively move, at least in part, the sheath hub <NUM> and the dilator hub <NUM> between the first end section <NUM> and the second end section <NUM>; this is done, preferably, after the sheath hub <NUM>, in use, abuts (contacts), at least in part, the dilator hub <NUM>.

Referring to the embodiments as depicted in <FIG>, the sheath assembly <NUM> also includes a sheath-handle assembly <NUM> (or a housing assembly) having a stationary shaft <NUM> defining a shaft lumen <NUM>. The stationary shaft <NUM> fixedly extends from the sheath-handle assembly <NUM>.

Referring to the embodiments as depicted in <FIG> and <FIG>, the sheath hub <NUM> is configured to be movably supported by the sheath-handle assembly <NUM>. The dilator-receiver device <NUM> is configured to selectively receive and support, at least in part, a dilator shaft <NUM> (elongated dilator shaft) and the dilator hub <NUM> of the elongated dilator assembly <NUM>. The hub cavity <NUM> is in fluid communication with the shaft lumen <NUM> of the stationary shaft <NUM>. The shaft lumen <NUM>, of the stationary shaft <NUM>, is configured to receive the dilator shaft <NUM> of the elongated dilator assembly <NUM>. It will be appreciated that the dilator shaft <NUM> may include a polymer based material, and/or any suitable material(s). The dilator shaft <NUM> may include, for instance, SAE (Society of Automotive Engineering) Type <NUM> Stainless Steel. SAE Type <NUM> stainless steel contains both chromium (from between about <NUM>% to about <NUM>%) and nickel (from between about <NUM>% to about <NUM>%) metals as the main non-iron constituents. As an alternative, the dilator shaft <NUM> may include a shape-memory material configured to be manipulated and/or deformed followed by a return to the original shape that the shape-memory material was set in (prior to manipulation). Shape-memory materials (SMMs) are known and not further described in detail. Shape-memory materials are configured to recover their original shape from a significant and seemingly plastic deformation in response to a particular stimulus is applied to the shape-memory material. This is known as the shape memory effect (SME). Superelasticity (in alloys) may be observed once the shape-memory material is deformed under the presence (an application) of a stimulus force.

Referring to the embodiments as depicted in <FIG> and <FIG>, the dilator-receiver device <NUM> includes a moveable shaft <NUM>. The moveable shaft <NUM> is configured to be moveable within a longitudinal length of the elongated sheath assembly <NUM>.

Referring to the embodiments as depicted in <FIG> and <FIG> (and <FIG> and <FIG>), there is depicted a method of operating an elongated sheath assembly <NUM> configured to receive, at least in part, an elongated dilator assembly <NUM>. The method includes selectively receiving and supporting, at least in part, the elongated dilator assembly <NUM> via a dilator-receiver device <NUM> mounted to, at least in part, the elongated sheath assembly <NUM>. The method also includes selectively moving, at least in part, the dilator-receiver device <NUM> and the elongated dilator assembly <NUM> along a predetermined distance <NUM>, via a dilator-receiver mover <NUM> operatively connected to the dilator-receiver device <NUM>, after the elongated dilator assembly <NUM> is received, at least in part, by the dilator-receiver device <NUM>. The method may include (in accordance with a preferred embodiment) having the dilator-receiver mover <NUM> mounted to the elongated sheath assembly <NUM>.

Referring to the embodiment as depicted in <FIG> and <FIG>, a lock device <NUM> (also called a latch device, etc.) may be provided. The lock device <NUM> may include a push-to-close-and-open latch (known to persons skilled in the art, and not depicted or described with further details). The lock device <NUM> is configured to selectively lock the sheath hub <NUM> and the dilator hub <NUM> to each other. The lock device <NUM> is also configured to selectively unlock the <NUM> and the dilator hub <NUM> from each other (for release purposes). The lock device <NUM> includes (preferably) a first lock portion 320A and a second lock portion 320B. The first lock portion 320A is mounted to the sheath hub <NUM> (that is, mounted to the surface of the sheath hub <NUM> that is exposed and facing outwardly (away) from the entrance portal <NUM>). The second lock portion 320B is mounted to the dilator hub <NUM> (that is, to an outer surface of the dilator hub <NUM>). Once the dilator hub <NUM> is positioned adjacent to (proximate to or abuts) the sheath hub <NUM>, the first lock portion 320A and the second lock portion 320B are aligned with each other (as depicted in <FIG>). The user may push the first lock portion 320A (of the dilator hub <NUM>) into the second lock portion 320B (of the sheath hub <NUM>); this action selectively latches the dilator hub <NUM> to the sheath hub <NUM> (with each other, as depicted in <FIG> and <FIG>). Once the procedure is completed, the user may (when appropriate) reverse the locking action (latching process): the user may push to cause or urge the first lock portion 320A (of the dilator hub <NUM>) temporarily into the second lock portion 320B (of the sheath hub <NUM>); this action selectively unlatches (releases) the dilator hub <NUM> from the sheath hub <NUM>); then, the elongated dilator assembly <NUM> may then be removed (entirely separated) away from the sheath assembly <NUM>. It will be appreciated that the lock device <NUM> is (preferably) mounted in a centered position on the dilator hub <NUM> and the sheath hub <NUM>, etc. (the mounting is depicted off-centered for purposes of clearly depicting the function and potential locations of the components of the lock device <NUM>, for the sake of keeping the FIGS. relatively clean by placing the lock device <NUM> off to the side, off centered).

Referring to the embodiments as depicted in <FIG>, the elongated dilator assembly <NUM> may be inserted into the sheath assembly <NUM> so that the dilator hub <NUM> may engage (contact, at least in part,) with the sheath hub <NUM>. Protrusion of the dilator distal tip <NUM> may be minimized (if so desired, until the tip of the sheath assembly <NUM> is positioned for deployment of the elongated dilator assembly <NUM>). The dilator assembly <NUM> is moveable along an insertion direction <NUM> aligned along, and within, the interior of the elongated sheath assembly <NUM> (such as the shaft lumen <NUM> and the moveable shaft <NUM>). The shaft lumen <NUM> is configured to slidably receive the moveable shaft <NUM>. The shaft lumen <NUM> is fixedly connected to the sheath-handle assembly <NUM>. The moveable shaft <NUM> extends from the sheath hub <NUM>. The sheath hub <NUM> is configured to be moveable along the hub cavity <NUM> (defined by the sheath-handle assembly <NUM>).

Referring to the embodiments as depicted in <FIG>, rotation of the input gear <NUM> causes the output gear <NUM> to become linearly translated, thereby linearly translating the moveable shaft <NUM> and the sheath hub <NUM>. In use, rotation of the input gear <NUM> causes the output gear <NUM> to become linearly translated, thereby linearly translating the moveable shaft <NUM>, the sheath hub <NUM> and the dilator hub <NUM> (after the dilator hub <NUM> is inserted into the sheath-handle assembly <NUM>, and the dilator hub <NUM> is made to abut, or contact, the sheath hub <NUM>).

Referring to the embodiments as depicted in <FIG>, when the dilator-receiver mover <NUM> (preferably, the input gear <NUM>) is activated (preferably, rotated), the sheath hub <NUM> is either moved forwards or backwards, effectively decreasing or increasing the total length of the elongated dilator assembly <NUM> that extends from the output section (such as the distal end section of the stationary shaft <NUM>, of the elongated sheath assembly <NUM>). In turn, the elongated dilator assembly <NUM> may either extend or retract from the distal tip of the stationary shaft <NUM> of the elongated sheath assembly <NUM>. The moveable shaft <NUM> may slide (move) with the sheath hub <NUM> in response to activation of the dilator-receiver mover <NUM>.

Referring to the embodiments as depicted in <FIG>, the sheath hub <NUM> and the dilator hub <NUM> are configured to selectively lock together. A lock mechanism <NUM> (also called a latch mechanism) is configured to selectively securely lock (or latch as depicted in <FIG>) the dilator-receiver mover <NUM> to the sheath-handle assembly <NUM> (or the elongated sheath assembly <NUM>); this is done so that the dilator-receiver mover <NUM> is not movable, or not rotatable, relative to the elongated sheath assembly <NUM>. The lock mechanism <NUM> is an optional feature. The lock mechanism <NUM> is configured to selectively unlock (unlatch as depicted in <FIG>) the dilator-receiver mover <NUM> from the sheath-handle assembly <NUM> (or the elongated sheath assembly <NUM>) so that the dilator-receiver mover <NUM> is movable, or rotatable, relative to the elongated sheath assembly <NUM>. The lock mechanism <NUM> may include any suitable type of lock mechanism (and is not further described herein in any specific details since a person skilled in the art would know how to design and install the lock mechanism <NUM>. The lock device <NUM> and the lock mechanism <NUM> may be deployed concurrently (together) or separately from each other (if so desired). In addition, the dilator-receiver mover <NUM> and the dilator-receiver device <NUM> provide an arrangement that improves precision adjustment of the protrusion length of the elongated dilator assembly <NUM> (extending from the end of the elongated sheath assembly <NUM>) by the operator (preferably, after securely locking the sheath hub <NUM> and the dilator hub <NUM> together). In accordance with another embodiment, the lock device <NUM> is configured to selectively lock, and unlock, the sheath hub <NUM> to, and from, the dilator hub <NUM>. The lock device <NUM> may include, for instance, a snap-fit connector, a press-fit connector, any type of locking device, etc., and/or any equivalent thereof.

Referring to the embodiment as depicted in <FIG>, the sheath hub <NUM> (such as a port on the proximal end of the elongated sheath assembly <NUM>) is configured to securely mate with the proximal end of the elongated dilator assembly <NUM>. The position of the sheath hub <NUM> may be adjusted using the dilator-receiver mover <NUM> such that the elongated sheath assembly <NUM> may move (slide) further into the elongated sheath assembly <NUM> (preferably when mated with the dilator hub <NUM>), or withdrawn from (from the interior of) the elongated sheath assembly <NUM>. It will be appreciated that the lock device <NUM> (known and not described in detail) may be deployed (if required) between the dilator hub <NUM> and the sheath hub <NUM>, and the lock device <NUM> may include any type of lock (e.g. snap fit, press fit, different shapes, materials, etc.), and/or any equivalent thereof. Preferably, the range of motion (of the dilator-receiver device <NUM> or the moveable shaft <NUM>) is in the order of centimeters. The dilator-receiver mover <NUM> is configured to provide precise submillimeter resolution of linear movement of the dilator-receiver device <NUM>. The dilator-receiver mover <NUM> may be located anywhere on the elongated sheath assembly <NUM> that is accessible by the operator.

Referring to the embodiment as depicted in <FIG>, the dilator hub <NUM> of the elongated dilator assembly <NUM> makes contact with (engages) the sheath hub <NUM> of the elongated sheath assembly <NUM>. The sheath hub <NUM> may be advanced forwardly (distally) via operation of the dilator-receiver mover <NUM>, resulting in increased protrusion of the elongated dilator assembly <NUM> from the tip section of end section of the elongated sheath assembly <NUM>.

Referring to the embodiment as depicted in <FIG>, the dilator hub <NUM> of the elongated dilator assembly <NUM> continues to make contact with (engage) the sheath hub <NUM> of the elongated sheath assembly <NUM>.

The sheath hub <NUM> is advanced to the most distal position or point, so that the protrusion of the elongated dilator assembly <NUM>, from the distal tip section of the elongated sheath assembly <NUM>, may be maximized (if, or when, desired during a procedure).

Referring to the embodiments as depicted in <FIG> and <FIG>, the dilator-receiver mover <NUM> is configured (preferably) to selectively move the dilator-receiver device <NUM> from a first predetermined distance <NUM> (as depicted in <FIG>) to a second predetermined distance <NUM> (as depicted in <FIG>); this is done in such a way that the elongated dilator assembly <NUM> is also moveable from the first predetermined distance <NUM> (as depicted in <FIG>) to the second predetermined distance <NUM>. Preferably, this is done in such a way that the dilator-receiver mover <NUM> and the elongated dilator assembly <NUM> are moveable between the first predetermined distance <NUM> (as depicted in <FIG>) and the second predetermined distance <NUM> (as depicted in <FIG>); that is, while a portion (such as, a dilator hub <NUM>) of the elongated dilator assembly <NUM> and a portion (such as a sheath hub <NUM>) of the elongated sheath assembly <NUM> remain in contact (in an abutment relationship) with each other. Advantageously, the elongated sheath assembly <NUM> may be configured to avoid swapping out the elongated dilator assembly <NUM> (during a procedure, if desired), thereby helping the surgeon avoid wasting valuable or critical surgical time. Advantageously, the elongated sheath assembly <NUM> may provide a workflow that starts with a long reach and tenting (over-tenting) the septum <NUM> (depicted in <FIG>), then withdrawing the dilator assembly <NUM> to an appropriate degree (or amount) of tent formed in a portion of the septum <NUM>; it will be appreciated that this methodology may be more intuitive than changing the curve of the dilator assembly <NUM>. Advantageously, the additional length of the elongated dilator assembly <NUM>, which may become moved and exposed during a procedure (that is, extended out from the end of the elongated sheath assembly <NUM>), may vary in an amount, or a length (a reasonable length), of an exposed portion of the dilator distal tip <NUM> (which extends from the end of the elongated sheath assembly <NUM>). This may be done, if desired, without having to swap out the elongated dilator assembly <NUM> during the procedure (thereby saving valuable or critical surgical time). For the case where the elongated dilator assembly <NUM> does not need to be swapped out for length issues, the elongated dilator assembly <NUM> may be withdrawn to adjust the curve of the elongated dilator assembly <NUM>. The dilator assembly <NUM> may be selectively extended, or moved, further out from (the output of) the sheath assembly <NUM>, while the elongated dilator assembly <NUM> remains mated (securely mated or in contact with) to the sheath assembly <NUM> during a procedure, so that the elongated dilator assembly <NUM> may become selectively exposed from the sheath assembly <NUM> (during the procedure). There is a range of positions (range of hub positions) spanning between the first predetermined distance <NUM> (as depicted in <FIG>) and the second predetermined distance <NUM>, in which the dilator-receiver device <NUM> (the moveable shaft <NUM>) may be moveable (reciprocated along a reciprocation path <NUM>, as depicted in <FIG>). The dilator-receiver device <NUM> and the dilator-receiver mover <NUM> advantageously provide physicians additional confidence and/or control during transseptal puncture (a procedure) such that the force to be applied to the septum has an appropriate level of impact to the tissue of the patient.

Claim 1:
An apparatus for an elongated sheath assembly (<NUM>) configured to receive, at least in part, an elongated dilator assembly (<NUM>), and the apparatus comprising:
a dilator-receiver device (<NUM>) mounted, at least in part, to the elongated sheath assembly (<NUM>);
characterized by
a dilator-receiver mover (<NUM>) configured to be operatively connected to the dilator- receiver device, and the dilator-receiver mover (<NUM>) also configured to selectively move the dilator-receiver device (<NUM>) along a predetermined distance; and optionally
the dilator-receiver mover (<NUM>) is mounted to the elongated sheath assembly (<NUM>).