Patent Description:
The present disclosure relates to devices for retrieving obstructions from bodily ducts.

An obstruction in a bodily duct of a patient can lead to chronic health issues, and even death, if the obstruction is left in place.

An example of such an obstruction is an embolus located in a blood vessel of a patient. The embolus may be a blood clot (thrombus), a fat globule (fat embolism) or foreign material. An embolism can cause partial or total blockage of blood flow in the affected vessel, such as a vessel in the neurovasculature of a patient. The capture and removal of such blockages can prevent the occurrence of a stroke or at least partially reverse the effects of a stroke.

A urinary tract obstruction is another example in which a blockage inhibits the flow of urine through its normal path (the urinary tract), including the kidneys, ureters, bladder, and urethra. Blockage can be complete or partial and can lead to kidney damage, kidney stones, and infection if not removed.

<CIT>; <CIT>; and <CIT>, are examples of relevant known prior art in this field.

Disclosed herein are devices for capturing and removing obstructions from bodily ducts of a patient.

According to some implementations a device for retrieving an obstruction in a bodily duct of a patient is provided that comprises a cylindrical body having a circumference and a longitudinal axis and including a plurality of cell structures of substantially the same size and shape arranged in diagonal rows around the longitudinal axis. According to some implementations the plurality of cell structures each includes first, second, third, fourth, fifth and sixth struts, each of the first, second, third, fourth, fifth and sixth struts having a proximal end and a distal end. According to some implementations the proximal end of the first strut is coupled to the proximal end of the second strut, the distal end of the third strut is coupled to the distal end of the fourth strut, the distal end of the first strut is coupled to the proximal end of the fifth strut, the proximal end of the third strut is coupled to the distal end of the fifth strut, the distal end of the second strut is coupled to the proximal end of the sixth strut, the proximal end of the fourth strut is coupled to the distal end of the sixth strut. According to some implementations the proximal and distal ends of the fifth strut are longitudinally aligned with one another and reside at a first circumferential location and the proximal and distal ends of the sixth strut are longitudinally aligned with one another and reside at a second circumferential location, the second circumferential location being spaced apart from the first circumferential location. According to some implementations, when the retrieval device is cut longitudinally and laid flat on a surface at least a first portion of each of the first, second, third and fourth struts is curved and at least a second portion of each of the first, second, third and fourth struts is straight.

According to other implementations, each of the first, second, third and fourth struts has a proximal end portion, a distal end portion and a mid-portion with the mid-portion being located between the proximal and distal end portions, the first and second end portions being curved and the mid-portion being straight when the device is cut longitudinally and laid flat on a surface.

According to other implementations a device for capturing and removing an obstruction in a bodily duct of a patient is provided that comprises a cylindrical body having a circumference and a longitudinal axis and including a plurality of closed cell structures arranged in a plurality of diagonal rows disposed around the longitudinal axis. At least some of the plurality of closed cell structures being substantially the same shape and size, at least some of the closed cells structures of substantially the same shape and size occupying a same circumferential location in the cylindrical body and being longitudinally separated from one another by no less than two, three, four or more diagonal rows of closed cell structures.

These and other advantages and features will become evident in view of the drawings and the detailed description.

<FIG> shows a perspective view of an obstruction retrieval system <NUM> according to one implementation. The retrieval system includes a self-expanding retrieval device <NUM> comprising a cylindrical body, such as those depicted in <FIG> and <FIG>, having a proximal end <NUM> that is coupled to the distal end <NUM> of an elongate wire <NUM> via a plurality of antennas <NUM>. Each of the plurality of antennas <NUM> is connected at a proximal end to the distal end <NUM> of the elongate wire <NUM>, and connected at a distal end to the proximal end <NUM> of the cylindrical body. As discussed below in more detail, according to some implementations the proximal end of the cylindrical body is coupled to the distal end of the elongate wire by a single antenna that extends proximally from a side of the cylindrical body.

In the example of retrieving an embolus from a blood vessel in the neurovasculature of a patient, according to some implementations, in use the self-expanding retrieval device is loaded into a distal end portion of a delivery catheter (not shown) and delivered with the delivery catheter to the site of the embolus. According to some implementations the distal end portion of the delivery catheter is positioned across the embolus and then withdrawn proximally to deploy the retrieval device into the embolus. According to other implementations the distal end portion of the delivery catheter that carries the retrieval device is positioned distal to the embolus and then proximally withdrawn to deploy the retrieval device at a location distal to the embolus. In such a case the embolus is captured by retracting the retrieval device <NUM> proximally into the embolus. This is accomplished by a clinician pulling on a proximal end portion <NUM> of the elongate wire <NUM> that resides outside the patient.

Keeping with the neurovascular obstruction example, upon the embolus being at least partially captured inside the retrieval device <NUM>, the retrieval device and the delivery catheter are singularly or together proximally withdrawn to effectuate a removal of the obstruction from the patient. According to some implementations the retrieval device <NUM> is at least partially withdrawn into the lumen of the delivery catheter during the removal process.

According to some implementations the retrieval device <NUM> has a length of between about <NUM> millimeters to about <NUM> millimeters and the elongate wire <NUM> has a length of between about <NUM> centimeters to about <NUM> centimeters.

As will be discussed in more detail below, the anatomy of certain bodily ducts is tortuous having regions of tight bends. A problem with many existing retrieval devices is that the captured obstruction tends to disengage with the retrieval device as the retrieval device is maneuvered through this tortuous path. The retrieval devices disclosed herein comprise features that enhance their ability to capture an obstruction and to more effectively remove the obstruction from the patient through a tortuous path comprising tight bends.

<FIG> and <FIG> illustrate exemplary retrieval devices <NUM> and <NUM>, respectively. <FIG> and <FIG> respectively show the retrieval devices <NUM> and <NUM> as if the retrieval devices were cut along a line parallel to their longitudinal axis and laid flat on a surface. Each of the retrieval devices <NUM> and <NUM> respectively comprises a cylindrical body <NUM> and <NUM> having a central longitudinal axis <NUM> and <NUM>. Each of the cylindrical bodies <NUM> and <NUM> is respectively comprised of a plurality of closed cell structures <NUM> and <NUM> that are disposed about its longitudinal axis. <FIG> and <FIG> represent the retrieval devices in an as-cut configuration typically resulting from the laser cutting of a metallic cylindrical tube made of, for example, a nickel-titanium alloy. It is important to note, however, that other manufacturing methods may be used to construct the retrieval devices disclosed herein.

In the example of <FIG> and <FIG>, the retrieval device <NUM> includes twelve diagonal rows of cell structures R1-R12 and possesses a central body portion <NUM> that extends between rows R3 and R11. According to some implementation, the cell structures that form the central body portion <NUM> are of substantially the same size and shape. According to some implementations, each row of cell structures in the central body portion <NUM> includes four cell structures that together surround the longitudinal axis <NUM> of the cylindrical body <NUM>.

In the example of <FIG> and <FIG>, the retrieval device <NUM> includes eight diagonal rows of cell structures R1-R8 and possesses a central body portion <NUM> that extends between rows R2 and R7. According to some implementation, the cell structures that form the central body portion <NUM> are of substantially the same size and shape. According to some implementations, each row of cell structures in the central body portion <NUM> includes three cell structures that together surround the longitudinal axis <NUM> of the cylindrical body <NUM>.

Retrieval devices having less than eight rows of cell structures, more than twelve rows of cell structures, and greater than four cell structures in a given row are also contemplated.

As explained above in the discussion of <FIG>, the cylindrical body portion of the retrieval device <NUM> is coupled to the distal end of an elongate wire <NUM> via the use of one or more antennas <NUM> that extend proximally from the proximal end <NUM> of the cylindrical body.

In the implementation of <FIG> and <FIG> the retrieval device <NUM> includes three antennas 28a, 28b and 28c that are straight and arranged parallel to the longitudinal axis <NUM> of the cylindrical body <NUM> in the as-cut configuration as shown in <FIG>. After the retriever <NUM> has been formed and polished, tabs or loops 29a-c that may be located at the proximal-most end of the antennas 28a-c are removed. The antennas 28a-c are then connected to the distal end of an elongate member <NUM> like that disclosed above in conjunction with the description of <FIG>. That is, the proximal ends of the antennas 28a-c converge to a common area where they are attached to the distal end <NUM> of the elongate wire <NUM>. By virtue of their convergence, the antennas 28a-c cause the retrieval device <NUM> to have a partially closed proximal end. According to other implementations the retrieval device <NUM> comprises a single antenna. For example, according some implementations the retrieval device <NUM> includes a single antenna that extends from a side of the cylindrical body <NUM> so that the proximal end of the retrieval device is fully open.

In the implementation of <FIG> and <FIG> the retrieval device <NUM> includes two antennas 68a and 68b that are straight and arranged parallel to the longitudinal axis <NUM> of the cylindrical body <NUM> in the as-cut configuration. After the retriever <NUM> has been cut and polished, the proximal ends of the antennas 68a-b, which may comprise tabs 69a-b, are connected to the distal end of an elongate member <NUM> like that disclosed above in conjunction with the description of <FIG>. That is, the proximal ends of the antennas 68a-b converge to a common area where they are attached to the distal end <NUM> of the elongate wire <NUM>. By virtue of their convergence, the antennas 28a-b cause the retrieval device <NUM> to have a partially closed proximal end. According to other implementations the retrieval device <NUM> comprises fewer or more than three antennas. For example, according some implementations the retrieval device <NUM> includes a single antenna that extends from a side of the cylindrical body so that the proximal end of the retrieval device is fully open.

In the implementations of <FIG> and <FIG>, the distal end of the retrieval devices <NUM> and <NUM> each respectively comprises an open distal end <NUM> and <NUM>. According to other implementations the distal ends of the retrieval devices may be partially closed, for example, by joining together the distal-most end segments <NUM> and <NUM> of the devices. In the example of <FIG> and <FIG>, according to some implementations the distal-most end segments <NUM> and <NUM> comprise features on which radiopaque markers may be affixed.

According to some implementations, the cylindrical body <NUM> of retrieval device <NUM> has a length of about <NUM> millimeters and an expanded outer diameter of about <NUM> millimeters. According to some implementations, the cylindrical body of retrieval device <NUM> has a length of about <NUM> millimeters and an expanded outer diameter of about <NUM> millimeters.

In terms of capturing an obstruction (e.g. an embolus) in a stent-like retrieval device like those disclosed herein, the effectiveness of capturing the obstruction is compromised in the current state of the art retrieval devices as a result of the frequency by which the longitudinal and circumferential location of like (e.g. same size and shape) cell structures are repeated. To address this problem, according to some implementations, like cell structures in retrieval devices <NUM> and <NUM> occupying a same circumferential location are separated by no less than two diagonal rows. In the implementations depicted in <FIG> and <FIG>, like cell structures occupying a same circumferential location are separated by no less than four diagonal rows. An advantage of these configurations is that a greater degree of irregularity exits in the structure of the retrieval device along its length that enhances its ability to entrap an obstruction. This is a result of the obstruction being exposed to a greater number of different geometries along the length of the retrieval device which reduces slippage and improves integration of the obstruction into the retrieval device.

With reference to <FIG>, like cell structures A1 and A2 occupy a same circumferential location in the central body portion <NUM> of the cylindrical body <NUM> with cell structure A1 residing in diagonal row R4 and cell structure A2 residing in diagonal row R9 with there being four intervening rows R5-R8 separating cell structures A1 and A2. Likewise, like cell structures B1 and B2 occupy a same circumferential location in the central body portion <NUM> of the cylindrical body <NUM> with cell structure B1 residing in diagonal row R6 and cell structure B2 residing in diagonal row R11 with there being four intervening rows R7-R10 separating cell structures B1 and B2. In addition, like cell structures C1 and C2 occupy a same circumferential location in the central body portion <NUM> of the cylindrical body <NUM> with cell structure C1 residing in diagonal row R3 and cell structure C2 residing in diagonal row R8 with there being four intervening rows R4-R7 separating cell structures C1 and C2. According to other implementations, like cell structures occupying a same circumferential location are separated by no less than three intervening diagonal rows of cell structures.

With reference to <FIG>, like cell structures A1 and A2 occupy a same circumferential location in the central body portion <NUM> of the cylindrical body <NUM> with cell structure A1 residing in diagonal row R2 and cell structure A2 residing in diagonal row R7 with there being four intervening rows R3-R6 separating cell structures A1 and A2. Likewise, like cell structures B1 and B2 occupy a same circumferential location in the central body portion <NUM> of the cylindrical body <NUM> with cell structure B1 residing in diagonal row R3 and cell structure B2 residing in diagonal row R8 with there being four intervening rows R4-R7 separating cell structures B1 and B2. According to other implementations, like cell structures occupying a same circumferential location are separated by no less than three intervening diagonal rows of cell structures.

<FIG> is an enlarged view of rows R3-R5 located in the central body portion <NUM> of retrieval device <NUM> with cell structure A1 residing in row R4. The configuration of cell structure A1 is representative of at least a majority of the cell structures within the retrieval device <NUM>. Cell structure A1 includes a first strut <NUM>, a second strut <NUM>, a third strut <NUM>, a fourth strut <NUM>, a fifth strut <NUM> and a sixth strut <NUM>, with each of the first, second, third, fourth, fifth and sixth struts having a proximal end and a distal end. The proximal end of the first strut <NUM> is coupled to the proximal end of the second strut <NUM> at a first longitudinal location L1, the distal end of the third strut <NUM> is coupled to the distal end of the fourth strut <NUM> at a second longitudinal location L2 distal to the first longitudinal location L1, the distal end of the first strut <NUM> is coupled to the proximal end of the fifth strut <NUM> at a third longitudinal location L3 that is located between the first and second longitudinal locations L1 and L2, the proximal end of the third strut <NUM> is coupled to the distal end of the fifth strut <NUM> at a fourth longitudinal location L4 located between the second and third longitudinal locations L2 and L3, the distal end of the second strut <NUM> is coupled to the proximal end of the sixth strut <NUM> at a fifth longitudinal location L5 that is located between the second and third longitudinal locations L2 and L3, the proximal end of the fourth strut <NUM> is coupled to the distal end of the sixth strut <NUM> at a sixth longitudinal location L6 that is located between the second and fifth longitudinal locations L2 and L5.

As best seen in <FIG> and <FIG>, among the plurality of cell structures in retrieval devices <NUM> and <NUM>, adjacent cell structures share at least one of the first, second, third, fourth, fifth and sixth struts with one another with the adjacent cell structures being both longitudinally and circumferentially offset from one another.

In the implementation of <FIG>, when the cylindrical body <NUM> of the retrieval device <NUM> is cut longitudinally and laid flat on a surface the third and fourth longitudinal locations L3 and L4 are longitudinally aligned with one another (that is, a straight line drawn between longitudinal locations L3 and L4 is parallel to the longitudinal axis <NUM> of the cylindrical body <NUM>) and reside at a common first circumferential location, and the fifth and sixth longitudinal locations L5 and L6 are longitudinally aligned with one another (that is, a straight line drawn between longitudinal locations L5 and L6 is parallel to the longitudinal axis <NUM> of the cylindrical body <NUM>) and reside at a common second circumferential location with the second circumferential location being spaced apart from the first circumferential location.

According to some implementations, when the cylindrical body <NUM> of the retrieval device <NUM> is cut longitudinally and laid flat on a surface at least one of the fifth strut <NUM> and sixth strut <NUM> is straight. According to other implementations each of the fifth strut <NUM> and sixth strut <NUM> is straight as shown in <FIG>. An advantage of one or both of the fifth and sixth struts being straight is that it advantageously endows the retriever <NUM> with a greater stiffness along its length than would otherwise exist if the struts were curved.

According to some implementations the fourth longitudinal location L4 and fifth longitudinal location L5 are circumferentially non-aligned with one another as shown in <FIG>. According to other implementations the fourth longitudinal location L4 and fifth longitudinal location L5 are circumferentially aligned with one another. A circumferentially alignment of the fourth and fifth longitudinal locations circumferentially aligns the distal end of the fifth strut <NUM> with the proximal end of the sixth strut <NUM> to produce a longitudinally continuous straight section within the cell structure A1, albeit circumferentially offset, that assists in providing the retriever with zones of enhanced stiffness.

As discussed above, a problem associated with removing a captured obstruction from a patient through a tortuous pathway is that when the retrieval device carrying the obstruction encounters and conforms to a tight bend, the obstruction is prone to being at least partially dislodged from the retriever. An advantage of providing a retriever with enhanced longitudinal stiffness is that it allows the retriever to at least partially straighten the bends through which it passes during the obstruction removal process. This reduces the risk of the obstruction being dislodge from the retrieval device as it is carried across the bends.

Another advantage of providing zones of enhanced longitudinal stiffness within the retrieval device is that it reduces the risk of the retrieval device buckling in procedures requiring the retrieval device to be pushed through the delivery catheter and/or through the bodily duct of the patient.

According to some implementations when the device is cut longitudinally and laid flat on a surface, as depicted in <FIG>, one or more or all of the first strut <NUM>, second strut <NUM>, third strut <NUM> and fourth strut <NUM> has a curved proximal end portion, a curved distal end portion and a straight portion located between the curved proximal and distal end portions. According to some implementations the straight portion is located in a middle portion of the strut. The curved proximal and distal end portions 1a, 1b, 2a, 2b, 3a, 3b, 4a, 4b of struts <NUM>-<NUM> contribute to providing a smooth transition between the connected struts of the cell structure and also provide the retrieval device <NUM> with a requisite amount of flexibility to enable it to navigate through the anatomy of a patient. The straight portion 1c, 2c, 3c, 4c of struts <NUM>-<NUM> enhances the longitudinal stiffness of the retrieval device <NUM> to provide the retrieval device with an ability to at least partially straighten the bends through which it passes during an obstruction removal process. As explained above, this reduces the risk of the obstruction being dislodged from the retrieval device as it is carried across tight bends. Another advantage of the mid-portion being straight is that it reduces the risk of the retrieval device buckling (as compared to entirely curved struts) in procedures requiring the retrieval device to be pushed through the delivery catheter and/or through the bodily duct of the patient.

According to some implementations one or more or all of struts <NUM>-<NUM> includes one or more straight portion that cumulatively occupy <NUM>% to <NUM>% of the overall length of the respective strut. According to other implementations one or more or all of struts <NUM>-<NUM> includes one or more straight portions that cumulatively occupy <NUM>% to <NUM>% of the overall length of the respective strut. According to some implementations one or more or all of struts <NUM>-<NUM> includes a single continuous straight portion that occupies <NUM>% to <NUM>% of the overall length of the respective strut. According to other implementations one or more or all of struts <NUM>-<NUM> includes a single continuous straight portion that occupies <NUM>% to <NUM>% of the overall length of the respective strut.

As noted above, according to some implementations the cylindrical body <NUM> of retrieval device <NUM> has a length of about <NUM> millimeters and an expanded outer diameter of about <NUM> millimeters. With reference to <FIG>, according to some implementations the cell structures in the central body portion <NUM> of retrieval device <NUM> have a cell height H of between about <NUM> millimeters and about <NUM> millimeters, a cell length L1 of between about <NUM> millimeters and about <NUM> millimeters, a circumferential offset CO of between about <NUM> millimeters and about <NUM> millimeters, a longitudinal offset LO of between about <NUM> millimeters and about <NUM> millimeters, a strut width W of between about <NUM> millimeters and about <NUM> millimeters, with struts <NUM> and <NUM> having a length L2 of between about <NUM> millimeters to about <NUM> millimeters.

According to some implementations the cylindrical body <NUM> of retrieval device <NUM> has a length of about <NUM> millimeters and an expanded outer diameter of about <NUM> millimeters. With reference to <FIG>, according to some implementations the cell structures in the central body portion <NUM> of retrieval device <NUM> have a cell height H of between about <NUM> millimeters and about <NUM> millimeters, a cell length L1 of between about <NUM> millimeters and about <NUM> millimeters, a circumferential offset CO of between about <NUM> millimeters and about <NUM> millimeters, a longitudinal offset LO of between about <NUM> millimeters and about <NUM> millimeters, a strut width W of between about <NUM> millimeters and about <NUM> millimeters, with struts <NUM> and <NUM> having a length L2 of between about <NUM> millimeters to about <NUM> millimeters.

As discussed above, retrieval devices <NUM> and <NUM> may be coupled to the distal end of an elongate wire <NUM> by one or more antennas that extend proximally from a proximal end of the cylindrical bodies <NUM> and <NUM>, respectively. According to some implementations in the as-cut configuration of the retrieval devices <NUM> and <NUM>, the one or more antennas are straight and aligned parallel to the longitudinal axis of the cylindrical body as shown in <FIG>, <FIG>, <FIG> and <FIG> with at least one of the antennas being longitudinally aligned with the proximal and distal ends of at least one of the fifth struts <NUM> and/or with the proximal and distal ends of at least one of the sixth struts <NUM>. That is, a line extending between the straight antenna and across the proximal and distal ends of at least one of the fifth and sixth struts is straight and disposed parallel to the longitudinal axis of the cylindrical body of the retrieval device. For example, as shown in <FIG>, each of antennas 28a and 28b is longitudinally aligned with at least one of the fifth and sixth struts of the cell structures residing in the central body portion <NUM> of the retrieval device <NUM>. An advantage of such a configuration is that it reduces the risk of the retrieval device buckling when being pushed by the elongate wire <NUM>.

It is sometimes important for the treating clinician to visualize the retrieval device during an obstruction remove procedure to ensure that the device is properly placed before being deployed. For this reason, according to some implementations the retrieval device <NUM> is equipped with a radiopaque wire or ribbon <NUM> that meanders between the inside and outside of the cylindrical body <NUM> in a pattern that preferably extends along a substantial portion of the length of the cylindrical body as shown in <FIG>. According to some implementations at least some of the struts of the retrieval device comprise a retaining feature <NUM>, as shown in <FIG>, through which the radiopaque wire or ribbon <NUM> passes as it meanders through the cylindrical body <NUM> of the retrieval device <NUM>. According to some implementations the retaining features <NUM> are formed during a laser cutting operation employed to construct the struts of the retrieval device. As discussed above, according to some implementations the retrieval device is constructed by laser cutting a cylindrical metallic tube to form the struts of the device. In the implementation of <FIG> the retaining feature <NUM> includes two L-shape like members <NUM> that are separated by a gap <NUM> through which the radiopaque wire or ribbon <NUM> passes when it assembled on the strut.

According to some implementations, the radiopaque wire or ribbon <NUM> is assembled on the retrieval device when the retrieval device is in a fully expanded state, and as such, does not impact the outward radial force of the retrieval device during its use. Further, according to other implementations, the radiopaque wire or ribbon <NUM> is assembled on the retrieval device in a manner such that it does not affect the flexure stiffness of the retrieval device.

Claim 1:
A device for capturing an obstruction in a bodily duct of a patient, the device comprising:
a cylindrical body (<NUM>, <NUM>) having a circumference and a longitudinal axis (<NUM>, <NUM>) and including a plurality of cell structures of the same size and shape and arranged in diagonal rows (R1-R12) around the longitudinal axis, each of the plurality of cell structures including first, second, third, fourth and fifth cell structures, the first cell structure being surrounded by the second, third, fourth and fifth cell structures and sharing at least one strut with each of the second, third, fourth and fifth cell structures, the plurality of cell structures each includes first, second, third, fourth, fifth and sixth struts, each of the first, second, third, fourth, fifth and sixth struts (<NUM>-<NUM>) having a proximal end and a distal end,
the proximal end of the first strut (<NUM>) being coupled to the proximal end of the second strut (<NUM>) at a first longitudinal location (L1), the distal end of the third strut (<NUM>) being coupled to the distal end of the fourth strut (<NUM>) at a second longitudinal location (L2) distal to the first longitudinal location (L1), the distal end of the first strut (<NUM>) being coupled to the proximal end of the fifth strut (<NUM>) at a third longitudinal location (L3), the proximal end of the third strut (<NUM>) being coupled to the distal end of the fifth strut (<NUM>) at a fourth longitudinal location (L4), the distal end of the second strut (<NUM>) being coupled to the proximal end of the sixth strut (<NUM>) at a fifth longitudinal location (L5), the proximal end of the fourth strut (<NUM>) being coupled to the distal end of the sixth strut at a sixth longitudinal location (L6), characterized in that
the fourth longitudinal location (L4) being proximal to the sixth longitudinal location (L6), the proximal and distal ends of the fifth strut (<NUM>) being longitudinally aligned with one another and residing at a first circumferential location, the proximal and distal ends of the sixth strut (<NUM>) being longitudinally aligned with one another and residing at a second circumferential location, the second circumferential location being spaced apart from the first circumferential location, when the device is cut longitudinally and laid flat on a surface at least a first portion of each of the first, second, third and fourth struts is curved and at least a second portion of each of the first, second, third and fourth struts is straight.