Patent Description:
Although endoscopic imaging modalities, such as fluoroscopy and endoscopic ultrasound (EUS), allow visualization of anatomical structures beyond the tissue directly in front of the endoscope, the inability to control (e.g., stabilize, immobilize, anchor, etc.) these distal anatomical structures during an endoscopy procedure presents challenges. For example, medical procedures such as gastrojejunostomy, hepaticogastrostomy, and gallbladder drainage, require the placement of a conduit (e.g., stent, etc.) within the appropriate portions of proximal and distal tissue walls. The tendency to lose control of the distal tissue wall during transmural stent deployment procedures presents a significant technical challenge to medical professionals, especially when a direct visual image of the distal tissue wall is unavailable. Failure to properly position the fluid conduit within the appropriate portions of the tissue walls may lead to serious medical complications.

A variety of advantageous medical outcomes may be realized by the systems and/or methods of the present disclosure, which minimize or prevent proximal and distal tissue walls from moving away from each other during a transmural stent placement procedure.

<CIT> discloses a technique for delivering a therapeutic agent to a target tissue that involves identifying a target tissue via an imaging modality and then using a guidewire capable of anchoring in tissue to advance a cannula to the target tissue.

<CIT> discloses a transluminal access system that includes a stent delivery catheter having a handle control mechanism. The catheter comprises a number of components for establishing an initial penetration between adjacent body lumens and subsequently implanting a stent or other luminal anchor therebetween. Manipulation of the stent components is achieved using control mechanisms on the handle while the handle is attached to an endoscope which provides access to a first body lumen.

<CIT> discloses a system for reducing the distance between two locations in tissue. An anchor may reside within the right ventricle in engagement with the septum. A tension member may extend from that anchor through the septum and an exterior wall of the left ventricle to a second anchor disposed along a surface of the heart.

<CIT> discloses an apparatus for delivering and deploying a closure element to an opening formed in a body lumen, including a delivery assembly positionable through the tissue and into the opening. The delivery assembly includes a distal locator portion and a carrier portion oriented proximal to the distal locator portion. The distal locator portion is configured to selectably engage the body lumen adjacent to the opening, and the carrier portion is configured to carry and support the closure element in a substantially tubular configuration.

According to the invention, an endoscope as recited in the independent claim is provided. The dependent claims define embodiments.

A system may comprise a needle that includes a proximal end, a sharpened distal end, and a lumen extending therebetween. An elongate member may be slidably disposed within the lumen, with a distal portion of the elongate member configured to move between a first configuration when disposed within the lumen, and a second configuration when disposed distally beyond the sharpened distal end.

The distal portion of the elongate member may be substantially linear in the first configuration, and substantially non-linear in the second configuration. The second configuration may include a loop, spiral or figure-eight shape. The distal portion may be split along a longitudinal axis of the elongate member to define first and second splines. The first and second splines may be substantially co-linear with the elongate member in the first configuration. The first and second splines may form Y-shape, T-shape or W-shape in the second configuration. Alternatively, the first and second splines form substantially spherical or oblong structures in the second configuration.

The system may comprise a needle that includes a proximal end, a sharpened distal end, and a lumen extending therebetween. An elongate member may be slidably disposed within the lumen. The elongate member may include a control rod, and a sheath slidably disposed around the control rod, with a distal portion of the elongate member configured to move between a first configuration when disposed within the lumen, and a second configuration when disposed distally beyond the sharpened distal end. A distal portion of the sheath may include at least one slit formed therein, wherein a distal end of the control rod is attached to a distal end of the sheath. The distal portion of the sheath may move from the second configuration to the first configuration by distally advancing the sheath over the control rod. Alternatively, the distal portion of the sheath may move from the first configuration to the second configuration by proximally retracting the control rod through the sheath. Alternatively, the distal portion of the sheath may move from the first configuration to the second configuration by distally advancing the sheath over the control rod. The distal portion of the sheath may move from the second configuration to the first configuration by distally advancing the control rod through the sheath. Alternatively, the distal portion of the sheath may move from the second configuration to the first configuration by distally retracting the sheath over the control rod. The distal portion of the sheath may form a basket in the second configuration.

There is also disclosed a method comprising advancing a penetrating a needle with a sharpened distal end and lumen running from a proximal end to the distal end through a tissue wall of a first body lumen and a tissue wall of a second body lumen adjacent to the first body lumen, and distally advancing an elongate member through the lumen of the needle such that the distal portion of the elongate member moves to a second configuration in contact with a portion of the tissue wall of the second body lumen to effect the position of the second body lumen relative to the first body lumen. The method may further include withdrawing the needle from over the elongate member and advancing a stent delivery system over the elongate member such that a distal end of the stent delivery system forms opposing holes in the tissue walls of the first and second body lumens. The method may further include deploying a stent from the stent delivery systems between the first and second body lumens. The method may further include distally retracting the elongate member through the stent delivery system and removing the stent delivery system.

The present disclosure is not limited to the particular embodiments described. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.

Although embodiments of the present disclosure are described with specific reference to certain procedures, such as a gastrojejunostomy procedure, the systems and methods described herein may be used to position a fluid conduit between a variety of adjacent tissue walls, organs, vessels and/or body lumens.

As used herein, the term "distal" refers to the end farthest away from the medical professional when introducing a device into a patient, while the term "proximal" refers to the end closest to the medical professional when introducing a device into a patient.

In various of the embodiments described here and in other embodiments, the present disclosure relates to a system which prevents or minimizes movement between tissue walls during a transmural medical procedure in which a direct visual image and/or control of the distal tissue wall is difficult or not available.

Referring to <FIG>, in one embodiment, a system <NUM> of the present disclosure may include a tissue-penetrating element <NUM> (e.g., needle, etc.) comprising a proximal end (not shown), a sharpened distal end <NUM> and a lumen <NUM> extending therebetween. An elongate member <NUM> (e.g., rail, guidewire, etc.) comprising a proximal end (not shown) and a distal end <NUM> may be slidably disposed within the lumen <NUM> of the tissue-penetrating element <NUM>. A distal portion <NUM> of the elongate member <NUM> may be split (e.g., divided) along a longitudinal axis thereof to define first and second splines 125a, 125b (e.g., tines, forks, branches, prongs, arms, etc.). The first and second splines 125a, 125b may be substantially co-linear with a longitudinal axis of the elongate member <NUM> when disposed within the lumen <NUM> of the tissue penetrating element <NUM>. At least the distal portion <NUM> of the elongate member <NUM> may include a variety of shape memory materials as are known in the art (e.g., metals, alloys, polymers, and the like), configured to move between a first configuration when disposed within lumen <NUM> of the tissue-penetrating element <NUM>, and a second configuration when disposed distally beyond the sharpened distal end <NUM> of the tissue-penetrating element <NUM>. The distal portion <NUM> of the elongate member <NUM> is not limited to two splines, but may include any number of splines (e.g., three or more splines).

Referring to <FIG>, in one embodiment, the first and second splines 125a, 125b may move or deflect substantially perpendicular to the longitudinal axis of the elongate member <NUM> to form a "T-shape" when in the second configuration. Referring to <FIG>, in one embodiment, the first and second splines 125a, 125b may move or deflect substantially tangential to the longitudinal axis of the elongate member <NUM> to form a "Y-shape" when in the second configuration. Referring to <FIG>, in one embodiment, the first and second splines 125a, 125b may bend back along/over and parallel to the longitudinal axis of the elongate member <NUM> to form a "W-shape" when in the second configuration. Referring to <FIG>, in one embodiment, the first and second splines 125a, 125b may curl back along/over the longitudinal axis of the elongate member <NUM> to form opposed substantially spherical (e.g., circular) shapes when in the second configuration. Referring to <FIG>, in one embodiment, the first and second splines 125a, 125b may curl back along/over the longitudinal axis of the elongate member <NUM> to form opposed substantially oblong (e.g., elliptical, elongate sphere, etc.) shapes when in the second configuration. Referring to <FIG>, in one embodiment, the first and second splines 125a, 125b may curl back along/over the longitudinal axis of the elongate member to form opposed substantially oblong shapes, which are spaced apart (e.g., separated) from the longitudinal axis of the elongate member when in the second configuration. Although the distal portions <NUM> of the elongate members <NUM> are depicted as forming substantially symmetrical structures, in various embodiments the first and second splines 125a, 125b may form any combination of the second configurations depicted in <FIG>, or other configurations not depicted. In various embodiments, when in the second configuration, the first and second splines 125a, 125b may move (e.g., deflect, bend, twist, compress, etc.) independent of each other when placed in contact with an inner surface of a tissue wall, as discussed below.

Referring to <FIG>, in one embodiment, a system <NUM> of the present disclosure may include a tissue-penetrating element <NUM> (e.g., needle, etc.) comprising a proximal end (not shown), a sharpened distal end <NUM> and a lumen <NUM> extending therebetween. An elongate member <NUM> (e.g., rail, guidewire, etc.) comprising a proximal end (not shown) and a distal end <NUM> may be slidably disposed within the lumen <NUM> of the tissue-penetrating element <NUM>. At least the distal portion <NUM> of the elongate member <NUM> may include a variety of shape memory materials as are known in the art (e.g., metals, alloys, polymers, and the like), configured to move between a first configuration when disposed within lumen <NUM> of the tissue-penetrating element <NUM>, and a second configuration when disposed (advanced) distally beyond the sharpened distal end <NUM> of the tissue-penetrating element <NUM>. Referring to <FIG>, in one embodiment, the distal portion <NUM> of the elongate member <NUM> may form a "loop" or "hoop" when in the second configuration. Referring to <FIG>, in one embodiment, the distal portion <NUM> of the elongate member <NUM> may bend approximately <NUM> degrees relative to the longitudinal axis of the elongate member <NUM> to form a "reverse coil" or "reverse spiral" around a portion of the elongate member <NUM> when in the second configuration. Referring to <FIG>, in one embodiment, the distal portion <NUM> of the elongate member <NUM> may form a "figure-eight," lasso," or "cork screw" shape when in the second configuration. Referring to <FIG>, in one embodiment, the distal portion <NUM> of the elongate member <NUM> may bend to form a "cross-bar" that extends across the longitudinal axis of the elongate member <NUM> when in the second configuration.

The various second configurations of the distal portions <NUM>, <NUM> may provide a number of additional benefits to further secure/immobilize the distal tissue wall when the elongate member <NUM>, <NUM> is proximally retracted. By way of non-limiting example, the ends of the first and second prongs 125a, 125b depicted in any of <FIG> may partially penetrate/embed within the distal tissue wall. A portion of the splines 125a, 125b in any of <FIG>, or the distal portion <NUM> of the elongate member <NUM> of <FIG>, may include one or more hooks, barbs, prongs, etc. to provide enhanced friction against an inner wall of the distal tissue. In various embodiments, the splines 125a, 125b and/or distal portion <NUM> of the elongate member <NUM> may provide a gradual increase in retention pressure when the elongate member <NUM>, <NUM> is proximally retracted, thereby allowing the medical professional to exert more or less immobilizing force against the inner surface of the distal tissue wall as necessary throughout the course of the medical procedure. In addition, or alternatively, a portion of the surface of the splines 125a, 125b of any of <FIG> may include a sharpened edge configured to enlarge or expand the puncture hole created by the sharpened distal end <NUM> of the tissue-penetrating element <NUM> within the first and/or second tissue walls. One, or both, of the spherical or oblong shapes of <FIG>, respectively, may deflect (e.g., bend, splay, etc.) away from the longitudinal axis of the elongate member <NUM> to provide retention pressure across a larger surface area of the distal tissue.

Referring to <FIG>, in one embodiment, a system <NUM> of the present disclosure may include a tissue-penetrating element <NUM> (e.g., needle, etc.) comprising a proximal end (not shown), a sharpened distal end <NUM> and a lumen <NUM> extending therebetween. An elongate member <NUM> may be slidably disposed within the lumen <NUM> of the tissue-penetrating element <NUM>. The elongate member <NUM> may include a control rod <NUM> slidably disposed within a sheath <NUM>. A distal end <NUM> of the control rod <NUM> may be attached to a distal end <NUM> of the sheath <NUM>. A distal portion <NUM> of the sheath <NUM> may include one or more slits <NUM> formed therein, and be configured to move between a first configuration when disposed within lumen <NUM> of the tissue-penetrating element <NUM> (<FIG>), and a second configuration when disposed distally beyond the sharpened distal end <NUM> of the tissue-penetrating element <NUM> (<FIG>).

For example, at least the distal portion <NUM> of the sheath <NUM> may include a variety of materials, including, but not limited to shape memory materials, e.g., nitinol, polyether ether ketone (PEEK), etc., into which the one or more slits <NUM> are formed using, e.g., laser cutting. The elongate member <NUM> may be advanced through the lumen <NUM> of the tissue-penetrating element <NUM> by distally advancing the control rod <NUM> (<FIG>). In one embodiment, the distal portion <NUM> of the sheath <NUM> may move to the second configuration by distally advancing the sheath <NUM> over/along the control rod <NUM>. Alternatively, the distal portion <NUM> of the sheath <NUM> may move to the second configuration by proximally retracting the control rod <NUM> through/within the sheath <NUM> (<FIG>). In either embodiment, the one or more slits <NUM> may allow the distal portion <NUM> to form a "basket" that includes a series of arms or petals configured to engage the distal tissue wall. In one embodiment, the distal portion <NUM> may include one or more hooks, barbs, prongs, etc. for enhanced friction against the distal tissue wall. Although <FIG> depict an embodiment in which the distal portion <NUM> includes <NUM> slits configured to form <NUM> arms or petals when in the second configuration, in various embodiments, the distal portion may include any number of slits configured to form a variety of second configurations.

In one embodiment, the elongate members <NUM>, <NUM>, <NUM> disclosed herein may be disposed within, and delivered through, a tissue-penetrating element <NUM>, <NUM>, <NUM> that includes a <NUM> or <NUM>-gauge needle used for fine-needle aspiration (FNA) or fine-needle biopsy (FNB) procedures, as are known in the art. In addition, or alternatively, the tissue penetrating elements <NUM>, <NUM>, <NUM> and/or elongate members <NUM>, <NUM>, <NUM> may beneficially include a coating, such as a fluorinated polymer or paralene, to provide electrical insulation and/or improved lubricity. To prevent coring of the proximal or distal tissue walls, the distal portion <NUM>, <NUM>, <NUM> of the elongate member <NUM>, <NUM>, <NUM> may be configured to obturate the lumen <NUM>, <NUM>, <NUM> at or near the sharpened distal end <NUM>, <NUM>, <NUM> of the tissue-penetrating element <NUM>, <NUM>, <NUM>.

In one embodiment, a system <NUM>, <NUM>, <NUM> of the present disclosure may be delivered through the working channel of an endoscope. Referring to <FIG>, in use and by way of example, an ultrasound endoscope <NUM> may be advanced through the esophagus into a first body lumen <NUM> (e.g., the stomach). The distal end <NUM> of the endoscope <NUM> may include a camera <NUM>, light source <NUM> and ultrasound transducer <NUM>. Using the direct view (e.g., the light source <NUM> and camera <NUM>) the distal end <NUM> of the endoscope <NUM> may be positioned adjacent to a tissue wall <NUM> (e.g., proximal tissue wall) of the first body lumen <NUM> which is in the vicinity of the tissue wall <NUM> (e.g., distal tissue wall) of a second body lumen <NUM> (e.g., the duodenum or jejunum). The second body lumen <NUM> may then be imaged through the first tissue wall <NUM> by switching the endoscope <NUM> from the direct view to an ultrasound view (e.g., turning off the light source <NUM> and turning on the ultrasound transducer <NUM>). The system <NUM> may then be advanced through the working channel <NUM> of the endoscope <NUM> such that the sharpened distal end <NUM> of the tissue-penetrating element <NUM> penetrates the first and second tissue walls <NUM>, <NUM>, and extends into the second body lumen <NUM>.

Referring to <FIG>, the elongate member <NUM> may be distally advanced beyond the sharpened distal end of the tissue-penetrating element such that the distal portion <NUM> moves to the second configuration within the second body lumen <NUM>. The tissue-penetrating element may then be removed along/over the elongate member <NUM> (e.g., proximally withdrawn) through the working channel <NUM> of the endoscope <NUM>. The elongate member <NUM> may then be proximally retracted to place the distal portion <NUM> in contact with an inner portion of the second distal tissue wall <NUM>, and with sufficient force to minimize or prevent (e.g., anchor) movement of the distal tissue wall <NUM> relative to the proximal tissue wall <NUM>.

Referring to <FIG>, with the proximal and distal tissue walls <NUM>, <NUM> sufficiently immobilized with respect to each other, a stent delivery system <NUM> with a stent <NUM> loaded thereon may be advanced through the working channel <NUM> of the endoscope <NUM>. The stent delivery system <NUM> may include a lumen <NUM> configured to slide over/along the elongate member <NUM>. The distal end of the stent delivery system <NUM> may include a cutting element, e.g., electrocautery surface, configured to create opposed openings (e.g., holes) through the first and second tissue walls <NUM>, <NUM>. In one embodiment, the distal portion <NUM> of the elongate member <NUM> may provide a firm/secure platform against which the electrocautery surface of the stent delivery system <NUM> may press when forming the opposed openings. The distal portion <NUM> may provide the additional benefit of establishing separation between the opposite tissue wall of the second body lumen <NUM> and the stent delivery system to prevent unintentional cutting by the cutting element. In one embodiment, one (or both) of the oblong portions of the distal portion <NUM> may deflect away from the longitudinal axis of the elongate member <NUM> to provide retention pressure across a larger surface area of the distal tissue wall. In addition, or alternatively, the ability of the distal portion(s) <NUM> to deflect away from the longitudinal axis of the elongate member <NUM> may provide a space to allow: <NUM>) the cutting element of the delivery system <NUM> to fully penetrate the second body lumen <NUM>, <NUM>) unhindered deployment of the distal flange <NUM> of stent <NUM> (<FIG>), and/or <NUM>) introduction of an additional cutting element to further dilate (e.g., enlarge) the tissue opening without imparting excessive force on the opposite tissue wall of the second body lumen <NUM>. In addition, the oblong shape may provide a degree of flexibility to the distal portion <NUM>, such that the stent delivery system <NUM> may be advanced a sufficient distance into the second body lumen <NUM> to deploy the distal flange without further pushing the distal portion <NUM> against the opposite tissue wall. The distal portion <NUM> of the elongate member <NUM> may include a soft and/or compliant surface or coating to prevent trauma to the opposite tissue wall in the event contact therebetween occurs.

Referring to <FIG>, an outer portion of the stent delivery system <NUM> may then be proximally retracted over the inner lumen <NUM>, elongate member <NUM> and stent <NUM> to deploy the distal flange <NUM> of a stent <NUM> within the second body lumen <NUM>. Referring to <FIG>, the outer portion of the stent delivery system <NUM> may be further retracted over the inner lumen <NUM>, the elongate member <NUM> and the stent <NUM> to deploy the proximal flange <NUM> of the stent <NUM> within the first body lumen <NUM>. Referring to <FIG>, with the proximal and distal flanges <NUM>, <NUM> properly deployed within the first and second body lumens <NUM>, <NUM>, the elongate member <NUM> may be proximally retracted with sufficient force such that the distal portion <NUM> moves from the second configuration to the first configuration for removal through the lumen <NUM> of the stent delivery system. The endoscope <NUM>, stent delivery system <NUM> and elongate member <NUM> may then be removed from the patient. The stent configuration depicted in <FIG> is provided by way of non-limiting example, and may include a variety of different shapes, configurations, orientations, dimensions and/or materials as required to provide a flow pathway between adjacent tissue walls. In addition, an outer and/or inner surface of the stent may be fully or partially covered (e.g., across the saddle region between the proximal and distal flanges) to prevent fluid leakage between the tissue walls. Although <FIG> depict a gap between the tissue walls of the first and second body lumens <NUM>, <NUM> after placement of the stent, in other embodiments the procedure may result in the tissue walls being apposed into contact with each other along the saddle region, with the proximal and distal flanges providing contact with the respective inner surface of each tissue wall.

Although the systems <NUM>, <NUM>, <NUM> disclosed herein are configured to minimize or prevent proximal and distal tissue walls from moving away from each other during a medical procedure, rather than moving either tissue wall towards the other, in one embodiment, the elongate member <NUM>, <NUM>, <NUM> may be proximally retracted with sufficient force such that the distal portion <NUM>, <NUM>, <NUM> pulls the distal tissue wall over the stent delivery system <NUM> for deployment of the distal flange within the second body lumen <NUM>.

Referring to <FIG>, in one embodiment, the distal portion <NUM> of the elongate member <NUM> of <FIG> may include a first dimension D<NUM> (e.g., a width), a second dimension D<NUM> (e.g., a height) and a third dimension D<NUM> (e.g., an elevation) relative to the longitudinal axis of the elongate member <NUM>. By way of non-limiting example, the first dimension D<NUM> may be approximately <NUM> (<NUM> inches), the second dimension D<NUM> may be approximately <NUM> (<NUM> inches) and the third dimension D<NUM> may be approximately <NUM> (<NUM> inches). In various embodiments, the first, second and third dimensions D<NUM>-D<NUM> of the distal portion <NUM> may provide a space within which the distal flange <NUM> of a stent <NUM> may be deployed (e.g., within a second body lumen, as outlined above), while the distal portion <NUM> of the elongate member maintains contact with the tissue wall of the second body lumen throughout the stent deployment procedure.

In various embodiments, the elongate members <NUM>, <NUM>, <NUM> disclosed herein may be include sufficient flexibility and strength to repeatedly slide into and out of a tissue-penetrating element, or other medical device (e.g., retraction catheter, etc.), without breaking/fracturing and while maintaining the ability to move to the second configuration within the second body lumen (e.g., to provide the requisite retention strength). In addition, any of the elongate members <NUM>, <NUM>, <NUM> disclosed herein may include a suitable coating to facilitate slidable motion within a tissue-penetrating element, or other medical device. In various embodiments, such coating(s) may also impart dielectric strength the all, or a portion of, the elongate member.

The medical devices of the present disclosure are not limited to endoscopes, and may include a variety of medical devices for accessing body passageways, including, for example, catheters, bronchoscopes, ureteroscopes, duodenoscopes, colonoscopes, arthroscopes, cystoscopes, hysteroscopes, and the like. Finally, although the embodiments of the present disclosure have been described in use with an endoscope, the systems of the present disclosure may be positioned within the patient in the absence of an accompanying medical device.

Claim 1:
An endoscope comprising:
a working channel,
a stent delivery system (<NUM>) configured to be advanced through the working channel and comprising:
a stent (<NUM>) loaded on the stent delivery system (<NUM>),
a proximal end,
a distal end including a cutting element configured to create openings through tissue walls, and
a lumen (<NUM>) extending therebetween; and
the endoscope further comprising an elongate member (<NUM>) slidably disposed within the lumen (<NUM>), wherein a distal portion (<NUM>) of the elongate member (<NUM>) is configured to move between a first configuration when disposed within the lumen (<NUM>), and a second configuration when disposed distally beyond the distal end,
wherein the stent delivery system (<NUM>) comprises an outer portion configured to be proximally retracted over the inner lumen (<NUM>), elongate member (<NUM>) and stent (<NUM>) to deploy at least a distal flange (<NUM>) of the stent (<NUM>),
characterized in that,
the distal portion (<NUM>) of the elongate member (<NUM>) includes a first dimension (D1), a second dimension (D2) and a third dimension (D3) relative to a longitudinal axis of the elongated member providing a space within which the distal flange (<NUM>) of the stent (<NUM>) is deployed.