Patent Description:
Endoscope devices generally include a flexible shaft, a working distal tip, and a flexible steerable shaft joining the working tip and the flexible shaft. The flexible steerable shaft may include a bendable articulation joint. Drawbacks of conventional endoscopes include, for example, the inability to provide a small bend radius when the articulation joint provides both large and small bend angles. For example, articulation joints providing full retroflex (bending of the articulation joint to visualize proximally, for example an entry portal of the endoscope into a patient's stomach) generally require the articulation joint to bend by approximately <NUM> degrees or more. When the same conventional articulation joint is bent to less than <NUM> degrees, e.g., a <NUM> degree position, the articulation joint will make a gradual turn with a large radius, which is not suitable for areas of the human body having space constraints. These drawbacks can prevent the physician from properly visualizing and/or accessing areas of the body during procedures.

Accordingly, it is desirable for the articulation joint to provide a tightest acceptable bend radius when flexing the articulation joint to a maximum angle, and to achieve the same or similar tightest acceptable bend radius when flexing the articulation joint to a smaller angle. The present disclosure may solve one or more of these problems or other problems in the art. The scope of the disclosure, however, is defined by the attached claims and not the ability to solve a specific problem. <CIT>, which is considered to represent the most relevant prior art, relates to an elongated articulating neck comprising: a series of individual parts having an opening there through, the opening through such parts aligned along the length of the articulating neck to form a passageway though the neck, such parts being formed with a pair of diametrically opposed swivel tabs at one side and being formed with a pair of counterpart swivel sockets at the opposite side, adjacent parts being pivotally joined together by inter-engagement of the swivel tabs in the swivel socket with each swivel tab pivoting around a pivot point, the individual parts also being formed with a pair of diametrically opposed finger tabs located between the pair of swivel tabs at the one side and with a pair of counterpart finger sockets located between the pair of swivel sockets at the opposite side, finger tabs being moved into the finger sockets during bending of the neck and stopped by the bottom of the finger sockets to limit the bending radius of the neck, the finger tabs and the finger sockets being so dimensioned to provide a different bending radius on opposite sides of the neck; a self-adjusting electrically conducting member connecting immediately adjacent individual parts in electrical communication thereby maintaining electrical continuity along the length of the neck, the spacing along the length of the neck between the pivotally joined individual parts being sized to be a barrier to predetermine radio frequencies.

<CIT> discloses a joint portion in the bending portion for use in the insertion portion of an endoscope joints bending pieces with slide surfaces parallel to the rotation axis of bending and with slide surfaces perpendicular to the rotation axis. Since the slide surfaces receive external force exerted in the direction of the rotation axis in a direction perpendicular to the surfaces, they are resistant to displacement or twisting.

<CIT> relates to a medical device for managing tissue in an organ, such as the stomach, for retracting or positioning tissue and related organs to allow certain regions of the stomach to be acquired for a gastroplasty procedure. The medical device includes an elongated body having a proximal end and a distal end, and a tissue treatment device attached to the distal end of the elongated body. The tissue treatment device includes a first jaw opposite a second jaw, and each jaw is adapted to acquire tissue. A retractor is disposed along the tissue treatment device and adapted to be moveable from a delivery position to a retraction position to move or manage the tissue of the stomach. The medical device also includes a collapsible barrier disposed between the first and second jaws of the tissue treatment device to direct tissue into the first and second jaws separately.

<CIT> discloses devices and systems for controlling movement of a working end of a surgical device by means of a robotic system. In one embodiment, systems and devices are provided for moving an end effector on a distal end of a surgical fastening device. Movement can include rotational movement of the end effector about an axis of the shaft, articulation of the end effector relative to the shaft, and actuation of an end effector, e.g., closing, firing, and/or cutting.

According to an example, an articulation joint for a medical device includes proximal links, distal links, and intermediate links connecting the proximal and distal links. The articulation joint has a straight configuration along a straight longitudinal axis, a first bent configuration when the articulation joint bends toward a first side of the longitudinal axis, and a second bent configuration when the articulation joint bends toward a second side of the longitudinal axis, opposite to the first side. When the articulation joint is in the straight configuration, a first gap is defined at the first side between adjacent proximal links, and the adjacent proximal links contact each other at the second side, a second gap is defined at each of the first side and the second side between adjacent distal links, and a third gap is defined at the first side between adjacent intermediate links, and adjacent intermediate links contact each other at the second side.

When the articulation joint is in the first bent configuration, a size of each of the first, second, and third gaps on the first side, may be smaller than a size of the first, second, and third gaps on the first side respectively when the articulation joint is in the straight configuration.

When the articulation joint is completely bent toward the first side, surfaces of adjacent links may contact each other such that the side of each of the first, second, and third gaps on the first side is zero.

When the articulation joint is in the second bent configuration, a size of the second gaps on the second side may be smaller than a size of the second gaps on the second side when the articulation joint is in the straight configuration.

The distal links may be movable in exactly four directions, the proximal links may be movable in exactly one direction, and the intermediate links may be movable in two or three directions.

The articulation joint may include a third bent configuration toward a third side of the longitudinal axis, intermediate to the first and second sides, and a fourth bent configuration when the articulation joint bends toward a fourth side of the longitudinal axis, opposite to the third side, such that when the articulation joint is in the straight configuration, a fourth gap may be defined at each of the third side and the fourth side between the adjacent distal links, and a fifth gap may be defined at each of the third side and the fourth side between the adjacent intermediate links.

When the articulation joint is in the third bent configuration, a size of each of the fourth gaps and the fifth gaps on the third side may be smaller than a size of the fourth gaps and the fifth gaps on the third side respectively when the articulation joint is in the straight configuration, and when the articulation joint is in the fourth bent configuration, a size of each of the fourth gaps and the fifth gaps on the fourth side may be smaller than a size of the fourth gaps and the fifth gaps on the fourth side respectively when the articulation joint is in the straight configuration.

The fourth gaps and the fifth gaps may be offset from the first, second, and third gaps along the longitudinal axis.

The articulation joint may move in one of the first or the second direction and one of the third or the fourth direction at a same time.

Proximal links, distal links, and intermediate links of the articulation joint may be each attached to an adjacent link by a first spring and a second spring, and the first spring and the second spring of attached links may be on circumferentially opposite sides of the articulation joint.

The first and the second springs may be attached on an inner surface of each of the proximal links, distal links, and intermediate links by one or more of welding, brazing, soldering, or an adhesive.

Adjacent coils of each of the first spring and the second spring may contact each other when the first springs and the second springs are in a straight configuration.

Each of the first spring and the second spring may define a lumen for containing an articulation element.

A bend angle associated with each of the first, second, third, fourth, and fifth gaps may be equal.

The articulation joint may include a tip portion attached to a distal end of the distal links, wherein the tip portion includes one or more of an imaging device, lighting device, an end effector, and a cannulation for passage of secondary instrumentation.

Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms "comprises," "comprising," "having," "including," or other variations thereof, are intended to cover a non-exclusive inclusion such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such a process, method, article, or apparatus. In this disclosure, relative terms, such as, for example, "about," "substantially," "generally," and "approximately" are used to indicate a possible variation of ±<NUM>% in a stated value or characteristic.

Referring to <FIG>, an endoscope <NUM> according to an embodiment is shown. Endoscope <NUM> includes a flexible shaft <NUM>, a tip <NUM> at a distal end of endoscope <NUM>, and an articulation joint <NUM> disposed between and connecting flexible shaft <NUM> and tip <NUM>. A handle <NUM> or some other device for actuating or controlling endoscope <NUM>, and any tool or devices associated with endoscope <NUM>, is connected at a proximal end of flexible shaft <NUM>.

A plurality of actuating elements <NUM>, such as cables or wires suitable for medical procedures (e.g., medical grade plastic or metal), extend distally from a proximal end of endoscope <NUM>. Actuating elements <NUM> are shown between adjacent links in, e.g., <FIG>. Actuating elements <NUM> may extend into handle <NUM> and may be indirectly coupled to first and second actuating devices <NUM>, <NUM>, which control articulation of articulation joint <NUM> in multiple directions. Devices <NUM>, <NUM>, may be, for example, rotatable knobs that rotate about their axes to push/pull actuating elements <NUM>. Alternatively, or additionally, a user may operate actuating elements <NUM> independently of handle <NUM>. Distal ends of actuating elements <NUM> extend through flexible shaft <NUM> and terminate at actuating joint <NUM> and/or tip <NUM>. For example, one or more actuating elements <NUM> may be connected to articulation joint <NUM> and one or more other actuating elements <NUM> may be attached to tip <NUM>. As will be explained herein, actuation of actuating elements <NUM> may control actuating joint <NUM>, tip <NUM>, and/or elements attached to tip <NUM>, such as an end effector (not shown). In addition, one or more electrical cables (not shown) may extend from the proximal end of endoscope <NUM> to tip <NUM> and may provide electrical controls to imaging, lighting, and/or other electrical devices on tip <NUM>, and may carry imaging signals from tip <NUM> proximally to be processed and/or displayed on a display. Handle <NUM> may also include ports <NUM>, <NUM> for introducing and/or removing tools, fluids, or other materials from the patient. Port <NUM> may be used to introduce tools. Port <NUM> may be connected to an umbilicus for introducing fluid suction, and/or wiring for electronic components.

As shown in <FIG>, articulation joint <NUM> includes a portion of a lumen <NUM> that extends through endoscope <NUM>. Articulation joint <NUM> also includes a plurality of springs <NUM>. For ease of understanding, only some of the plurality of springs <NUM> are identified in <FIG>. Further, springs <NUM> have been removed in <FIG> for ease of understanding (springs <NUM> are located between pairs of laser welds <NUM>, described below). Springs <NUM> connect adjacent links of articulation joint <NUM>, as will be described in greater detail herein. Lumen <NUM> may extend from handle <NUM> through flexible shaft <NUM> into articulation joint <NUM>, and through a distal end of tip <NUM>. Lumen <NUM> may receive tools, imaging devices, and other devices associated with endoscope <NUM> to perform endoscopic procedures. Further, tissue samples and/or other material may be removed from a patient through lumen <NUM>. It will be understood that endoscope <NUM>, including flexible shaft <NUM> and articulation joint <NUM>, are not limited to a single lumen <NUM>, and may include any number of lumens necessary for performing procedures. Alternatively, or additionally, one or more catheters (not show) may be introduced through lumen <NUM> to remove tissue and/or insert tools.

With continued reference to <FIG>, springs <NUM> define actuation holes <NUM> which receive actuation elements <NUM>. According to an example, one actuating element or a plurality of actuating elements <NUM> may be disposed in a single actuation hole <NUM> of each spring <NUM>. Additional actuation holes, such as eyelets (not shown), may extend from a proximal end of flexible shaft <NUM> to a distal end thereof, and may provide a path through which actuation elements <NUM> may extend, thereby preventing actuating elements <NUM> from becoming tangled or otherwise adversely affecting an operation of endoscope <NUM>.

With reference to <FIG>, a distalmost link <NUM> may connect to tip <NUM>. Tip <NUM> may include a camera (not shown), lighting, electronics (such as a printed circuit board), an end effector or tool (not shown), or any other device used in a therapeutic or a diagnostic procedure. It will be understood that tip <NUM> may include multiple elements, e.g., both the camera and the end effector, to both visualize a target site and to collect samples from the target site.

Articulation joint <NUM> will be described with reference to <FIG> and <FIG>. Articulation joint <NUM> includes a plurality of generally cylindrical links with a plurality of gaps provided therebetween. For example, as shown in <FIG>, articulation joint <NUM> includes a first proximal link section <NUM>, a third distal link section <NUM>, and a second intermediate link section <NUM> provided between and connecting the first link section <NUM> and the third link section <NUM>. First, second, and third link sections <NUM>, <NUM>, <NUM> are formed of a first link type 50a, a second link type 50b, and a third link type 50c, respectively (see <FIG>). According to an example, first, second, and third link types 50a, 50b, 50c may be the same or different shapes and/or sizes. For example, first link type 50a is longer along longitudinal axis A than second and third link types 50b, 50c. Unless specified otherwise, first link type 50a, second link type 50b, and third link type 50c will generally be referred to as a "link. " Links may be formed by, for example, laser cutting a tube (such as a metal tube, a plastic tube, or any other medical grade material known in the art), but are not limited to being formed in this manner.

As further shown in <FIG>, springs <NUM> join adjacent links in each of first, second, and third link sections <NUM>, <NUM>, <NUM>. Additionally, springs <NUM> may connect a distalmost link of first link section <NUM> to a proximalmost link of second link section <NUM>, may connect a distalmost link of second link section <NUM> to a proximalmost link of third link section <NUM>, and/or may connect a distalmost link of third link section <NUM> to distalmost link <NUM>. As will be described in greater detail herein, adjacent links are capable of bending with respect to each other due to spacing between links and via the flexibility of springs <NUM>. While examples illustrate two springs <NUM> joining adjacent links, the invention is not limited to this configuration. According to an example, springs <NUM> are attached to an inner surface of articulation joint <NUM> by, e.g., laser welding, adhesives, rivets, or any other technique known in the art. For example, laser welds <NUM> are shown on adjacent links in <FIG> at locations at which springs <NUM> are attached.

As shown in <FIG> and <FIG>, articulation joint <NUM> is in a straight configuration and includes a longitudinal axis A extending through a center of each of first, second, and third link sections <NUM>, <NUM>, <NUM>. Articulation joint <NUM> is configured to bend in four different directions <NUM> degrees apart from each other about axis A (e.g., up, down, left and right directions). The directions of bending are designated as first side 58a, second side 58b, third side 58c, and fourth side 58d, approximately <NUM> degrees from each adjacent side. First side 58a is opposite second side 58b (approximately <NUM> degrees apart), and third side 58c is opposite fourth side 58d (approximately <NUM> degrees apart). As shown in <FIG>, <FIG>, links are bent in each of first, second, and/or third link sections <NUM>, <NUM>, <NUM> with respect to each other. As further shown in <FIG>, springs <NUM> are located on only two adjacent sides, e.g., third side 58c and fourth side 58d, of first link section <NUM>. As will be described in greater detail below, springs <NUM> are located on first, second, third, and fourth sides 58a, 58b, 58c, 58d of second link section <NUM> and third link section <NUM>.

As shown in <FIG> and <FIG>, each link includes an end surface <NUM> facing an adjacent link and, in some instances, end surfaces <NUM> of adjacent links are in contact when articulation joint <NUM> is in the straight configuration. For example, end surface <NUM> of first link 50a contacts an end surface <NUM> of an adjacent link 50a on one of four sides of articulation joint <NUM> (e.g., second side 58b) when articulation joint <NUM> is in the straight configuration (contact may include point contact between adjacent end surfaces <NUM> at second side 58b of adjacent links 50a, and/or contact between adjacent surfaces <NUM> of adjacent links 50a from second side 58b toward one or both of first and third sides 58a, 58c in a circumferential direction of articulation joint <NUM>). For ease of understanding, only some end surfaces <NUM> are identified by a reference numeral in <FIG>. However, it will be understood that end surfaces <NUM> are provided at each end of every link.

On first side 58a of first link section <NUM>, end surface <NUM> of one link 50a is spaced from end surface <NUM> of an adjacent link 50a, approaches end surface <NUM> of the adjacent link 50a as articulation joint <NUM> bends toward first side 58a, and contacts end surface <NUM> of the adjacent link 50a when articulation joint <NUM> is completely bent toward first side 58a, as shown in <FIG>. As described above, springs <NUM> connect adjacent links 50a on only two sides, e.g., third side 58c and fourth side 58d. In addition, springs <NUM> are tightly wound coiled springs with no spaces between adjacent coils when the spring is in a straight configuration. For this reason, links having a first link type 50a in first link section <NUM> are incapable of bending toward third side 58c or fourth side 58d. According to an embodiment, therefore links 50a of first link section <NUM> bend in a single direction, e.g., toward first side 58a.

As further shown in <FIG> and <FIG>, end surface <NUM> of a second link 50b contacts end surface <NUM> of an adjacent link 50b on only one side, i.e., second side 58b, when articulation joint <NUM> is in the straight configuration. End surface <NUM> of third link type 50c does not contact end surface <NUM> of an adjacent link 50c when articulation joint <NUM> is in the straight configuration. When a second link 50b is bent toward first side 58a, end surface <NUM> of the second link 50b contacts end surface <NUM> of an adjacent second link 50b. When a third link 50c is bent toward first or second sides 58a, 58b, end surface <NUM> of the third link 50c contacts end surface <NUM> of an adjacent third link 50c. Contact between end surfaces <NUM> of adjacent links prevents further bending of adjacent links of articulation joint <NUM>, and results in the maximum bend of articulation joint <NUM> in that specific direction.

Further, as shown in <FIG>, springs <NUM> are attached to all four sides 58a, 58b, 58c, 58d of second link section <NUM> and third link section <NUM>. The springs <NUM> are attached to adjacent links at offset positions, however. For example, three adjacent links <NUM> (see <FIG>) include two pairs of adjacent links. The first pair of adjacent links 100A, 100B is attached together by springs <NUM> on first and second sides 58a, 58b, such that the first pair of adjacent links 100A, 100B are unable to be bent relative to each other toward first and second sides 58a, 58b. The second pair of adjacent links 100B, 100C is attached together via springs <NUM> on third and fourth sides 58c, 58d. Second pair of adjacent links 100B, 100C are therefore unable to bend toward third and fourth sides 58c, 58d with respect to each other due to the arrangement of springs <NUM>.

Adjacent links in each of first, second, and third link sections <NUM>, <NUM>, <NUM> are capable of bending with respect to each other in at least one direction. The angle at which adjacent links may bend and the spacing between these adjacent links may be equal to a smallest bend radius at which imaging wires and other components are capable of bending and remaining functional. For example, a largest bend angle B of adjacent links spaced apart by <NUM> inches to <NUM> inches is approximately <NUM> degrees to <NUM> degrees, preferably approximately <NUM> degrees to <NUM> degrees at a <NUM> inch to <NUM> inch spacing between adjacent links, and more preferably approximately <NUM> degrees at a <NUM> inch spacing between adjacent links.

Referring to <FIG>, longitudinal axis A extends in the Y-axis, and articulation joint <NUM> bends in the Y-Z plane. As shown in <FIG>, a first gap G is provided between adjacent links within the first link section <NUM>, and between a distalmost link in first link section <NUM> and a proximalmost link of second link section <NUM>, along a first side 58a of articulation joint <NUM>. A second gap H is provided between adjacent links in second link section <NUM> on first side 58a. A third gap is provided between links in third link section <NUM>, and between a distalmost link of third link section <NUM> and distalmost link <NUM>, on both first side 58a and second side 58b.

The first, second, and third gaps G, H, I allow articulation joint <NUM> to bend an amount equal to bend angle B multiplied by the number of total gaps. For example, if bend angle B is <NUM> degrees and there are seven total gaps on first side 58a, articulation joint <NUM> may bend <NUM> degrees from longitudinal axis A and allow tip <NUM> to point toward an entry point of endoscope <NUM> into the patient. The size of gaps G, H, and I may be varied to achieve a desired bend angle. It will also be understood that the bend angles are merely examples, and the bend angle of each different gap may be different for a gap type, e.g., each different gap G from the plurality of gaps G may have a different bend angle.

According to an example, third gaps I on second side 58b allow adjacent links to bend at a same angle B as first gaps G. However, that angle associated with third gaps I on second side 58b is not limited to angle B and may be any angle that optimizes the bend angle of articulation joint <NUM>. As shown in <FIG>, third gaps I allow third link section <NUM> and distalmost link <NUM> to bend away from longitudinal axis A toward second side 58b while first link section <NUM> and second link section <NUM> do not bend toward second side 58b, i.e., first link section <NUM> and second link section <NUM> remain coaxial with longitudinal axis A. This configuration allows articulation joint <NUM> to bend <NUM> degrees toward second side 58b. Since this bend is performed by bending at only some gaps, i.e., using only the three third gaps I, a bend radius of articulation joint <NUM> is reduced, thereby allowing articulation joint <NUM> to bend in smaller spaces. It will be understood that while second link section <NUM> is shown as being capable of bending in three directions, second link section <NUM> may be capable of bending in only two directions in some examples.

Referring to <FIG>, longitudinal axis A extends in the Y-axis and articulation joint <NUM> bends in the X-Y plane. As shown in <FIG>, second link section <NUM> and third link section <NUM> include a plurality of fourth gaps J on a third side 58c and a fourth side 58d of articulation joint <NUM>, opposite third side 58c. Fourth gap J is also between the distalmost link of second link section <NUM> and the proximal most link of third link section <NUM>, and the distalmost link of third link section <NUM> and distalmost link <NUM>. Fourth gaps J are not present in first link section <NUM>. According to an example, fourth gaps J permit adjacent links to bend at a same angle B as the angles associated with first, second, and third gaps G, H, I. However, the angle associated with fourth gaps J is not limited to angle B and may be any angle that optimizes the bend angle of articulation joint <NUM>. As further shown by comparing <FIG>, fourth gaps J are offset, or alternate, along longitudinal axis A from first, second, and third gaps G, H, I. For example, as discussed above, adjacent links may bend with respect to each other in first and/or second directions 58a, 58b, but not in third and fourth directions 58c, 58d, based on the arrangement of springs <NUM>. Similarly, adjacent links may bend with respect to each other in third and/or fourth directions 58c, 58d, but not in first and second directions 58a, 58b. Thus, in some examples, when a portion of articulation joint <NUM> is bent, two adjacent links may be bent together (e.g., first pair of adjacent links 100A, 100B may bend relative to each other toward one side or another).

Articulation joint <NUM> may bend in the X-Y plane with respect to longitudinal axis A. For example, if bend angle B is <NUM> degrees and there are four gaps J on each of third side 58c and fourth side 58d, articulation joint <NUM> may bend <NUM> degrees with respect to first link section <NUM> in both a left and right direction, i.e., toward third side 58c and fourth side 58d (i.e., a <NUM> degree deviation of second and third link sections <NUM>, <NUM> from longitudinal axis A). This configuration again limits the number of gaps necessary to achieve a desired bend angle of articulation joint <NUM>, thereby reducing the bend radius of articulation joint <NUM> to allow for greater maneuverability in smaller spaces. It will be understood that as articulation joint <NUM> bends toward one or more sides, surfaces defining the gaps at those side approach until the surfaces are in contact with each other and the respective gaps therefore completely close. A size of gaps on an opposite side of the bend will increase. Similarly, when articulation joint <NUM> moves from a bent position back toward the straight configuration, the closed gaps reopen, and the size of gaps on the opposite side of the bend will decrease. It will be understood that the angle of gap J on third side 58c and the angle of gap J on fourth side 58d do not need to be equal to each other and/or do not need to achieve the same total deviation of articulation joint <NUM> from longitudinal axis A. For example, gaps may be arranged on third side 58c and fourth side 58d such that a number of gaps and/or an angle of bend of the gaps on third side 58c is different than a number of gaps and/or an angle of bend of the gaps on fourth side 58d, resulting in different bend geometry at full flexion of articulation joint <NUM>.

Claim 1:
An articulation joint (<NUM>) for a medical device, the articulation joint (<NUM>) including:
proximal links (50a), distal links (50c, <NUM>), and intermediate links (50b) connecting the proximal and distal links (50a, 50c, <NUM>), wherein the articulation joint (<NUM>) has a straight configuration along a straight longitudinal axis (A), a first bent configuration when the articulation joint (<NUM>) bends toward a first side (58a) of the longitudinal axis (A), and a second bent configuration when the articulation joint (<NUM>) bends toward a second side (58b) of the longitudinal axis (A), opposite to the first side (58a),
wherein, when the articulation joint (<NUM>) is in the straight configuration:
a first gap (G) is defined at the first side (58a) between adjacent proximal links (50a), and the adjacent proximal links (50a) contact each other at the second side (58b),
a second gap (I) is defined at each of the first side (58a) and the second side (58b) between adjacent distal links (50c, <NUM>), and
a third gap (H) is defined at the first side (58a) between adjacent intermediate links (50b), and adjacent intermediate links (50b) contact each other at the second side (58b).